UNITED STATES

 SECURITIES AND EXCHANGE COMMISSION

 Washington, D.C. 20549

 FORM 10-K

 (Mark One)

 ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 For the fiscal year ended December 31, 2024

 OR

 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 For the transition period from
to

 Commission File Number: 001-41294

 Onconetix, Inc.

 (Exact name of registrant as specified in its
charter)

 Delaware

 81-2262816

 (State or other jurisdiction of

incorporation or organization)

 (I.R.S. Employer

Identification No.)

 201 E. Fifth Street, Suite 1900
 Cincinnati, OH

 45202

 (Address of principal executive offices)

 (Zip Code)

 Registrant's telephone number, including
area code: (513) 620-4101

 Securities registered pursuant to Section 12(b)
of the Act:

 Title of each class

 Trading Symbol(s)

 Name of exchange on which registered

 Common stock, $0.00001 par value

 ONCO

 The Nasdaq Stock Market LLC

 Securities registered pursuant to Section 12(g)
of the Act:

 None

 Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No

 Indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or 15(d) of the Act. Yes No

(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes No

has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
 No

is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company,"
and "emerging growth company" in Rule 12b-2 of the Exchange Act.

 Large accelerated filer

 Accelerated filer

 Non-accelerated filer

 Smaller reporting company

 Emerging Growth Company

 If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.

has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 726(b)) by the registered public accounting firm that prepared or
issued its audit report.

 If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements.

 Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's
executive officers during the relevant recovery period pursuant to §240.10D-1(b).

is a shell company (as defined in Rule 12b-2 of the Act). Yes
No

 Based on the closing price as reported on the
Nasdaq Capital Market, the aggregate market value of the Registrant's Common Stock held by non-affiliates on June 30, 2024 (the
last business day of the Registrant's most recently completed second fiscal quarter) was approximately $ 3.6 million. Shares of Common
Stock held by each executive officer and director and by each stockholder affiliated with a director or an executive officer have been
excluded from this calculation because such persons may be deemed to be affiliates. This determination of affiliate status is not necessarily
a conclusive determination for other purposes.

 As of May 30, 2025, the registrant had 44,358,422
shares of common stock, $0.00001 par value per share, outstanding.

 DOCUMENTS INCORPORATED BY REFERENCE

 None.

 EXPLANATORY NOTE

 On September 24, 2024, the Company effected a
Reverse Stock Split of all shares of its issued and outstanding Common Stock at a ratio of one-for-forty (1:40). The Company accounted
for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification
("ASC") 260, Earnings Per Share. All issued and outstanding common stock, common stock warrants, and share-based
awards' exercise prices and per share data in this report and the consolidated financial statements have been adjusted, on a retrospective basis,
to reflect the reverse stock split for all periods presented. The number of authorized shares and par value of the
preferred stock and common stock were not adjusted because of the reverse stock split.

 Page

 Cautionary Note Regarding Forward-Looking Statements

 ii

 Summary of Material Risks Associated with our Business

 iv

 Item 1.

 Business

 Item 1A.

 Risk Factors

 Item 1B.

 Unresolved Staff Comments

 Item 1C.

 Cybersecurity

 Item 2.

 Properties

 Item 3.

 Legal Proceedings

 Item 4.

 Mine Safety Disclosures

 Item 5.

 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 Item 6.

 [Reserved]

 Item 7.

 Management's Discussion and Analysis of Financial Condition and Results of Operations

 Item 7A.

 Quantitative and Qualitative Disclosures About Market Risk

 Item 8.

 Financial Statements and Supplementary Data

 Item 9.

 Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

 Item 9A.

 Controls and Procedures

 Item 9B.

 Other Information

 Item 9C.

 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

 Item 10.

 Directors, Executive Officers and Corporate Governance

 Item 11.

 Executive Compensation

 Item 12.

 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 Item 13.

 Certain Relationships and Related Transactions, and Director Independence

 Item 14.

 Principal Accountant Fees and Services

 Item 15.

 Exhibits and Financial Statement Schedules

 Item 16.

 Form 10-K Summary

 Signatures

 i

 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 This Annual Report on Form
10-K (this "Report") contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking
statements are contained principally in the sections titled "Risk Factors," "Management's Discussion and Analysis
of Financial Condition and Results of Operations," and "Business," but are also contained elsewhere in this Report.

 In some cases, you can identify
forward-looking statements by the words "may," "might," "will," "could," "would,"
"should," "expect," "intend," "plan," "objective," "anticipate,"
"believe," "estimate," "predict," "project," "potential," "continue"
and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future,
although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance
or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity,
performance, or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking
statements include, but are not limited to, statements about:

 our projected financial position and estimated cash burn rate;

 our estimates regarding expenses, future revenues and capital requirements;

 our ability to continue as a going concern;

 our need to raise substantial additional capital to fund our operations;

 our ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix AG ("Proteomedix");

 our reliance on third parties, including Laboratory Corporation of America ("LabCorp"), to develop, market, distribute and sell Proclarix;

 the successful development of our commercialization capabilities, including sales and marketing capabilities.

 our ability to maintain the necessary regulatory approvals to market and commercialize our product;

 the results of market research conducted by us or others;

 our ability to obtain and maintain intellectual property protection for our current product;

 our ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights;

 the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us;

 ii

 our reliance on third parties, including manufacturers and logistics companies;

 the success of competing therapies or diagnostics and products that are or become available;

 our ability to successfully compete against current and future competitors;

 our ability to expand our organization to accommodate potential growth and our ability to attract, motivate and retain key personnel;

 the potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization of our product;

 market acceptance of our product, the size and growth of the potential markets for our current product, and our ability to serve those markets; and

 disruptions in the business of Onconetix or Proteomedix, which could have an adverse effect on their respective businesses and financial results.

 These forward-looking statements
involve numerous risks and uncertainties. Although we believe that our expectations in these forward-looking statements are reasonable,
our expectations may later be found to be incorrect. Our actual results of operations or the results of other matters that we anticipate
herein could be materially different from our expectations. Important risks and factors that could cause our actual results to be materially
different from our expectations are generally set forth in "Risk Factors," Management's Discussion and Analysis of Financial
Condition and Results of Operations," and other sections of this Report. You should thoroughly read this Report and the documents
that we refer to with the understanding that our actual future results may be materially different and worse than what we expect. We qualify
all our forward-looking statements by these cautionary statements.

 The forward-looking statements
made in this Report relate only to events or information as of the date on which the statements were made. Except as required by law,
we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future
events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should
read this Report and the documents that we refer to in this Report and have filed as exhibits to this Report, completely and with the
understanding that our actual future results may be materially different from what we expect.

 iii

 SUMMARY OF MATERIAL RISKS
ASSOCIATED WITH OUR BUSINESS

 The following is a summary
of certain risks, uncertainties and other factors related to our company. These do not represent all of the risks we face. You should
carefully consider all of the risk factors presented in "Item 1A. Risk Factors" and all other information contained in this
Report including the financial statements in order to provide a more complete picture of the risk factors we face.

 Our business is subject
to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business,
financial condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our
common stock. These risks are discussed more fully in "Risk Factors" beginning on page 28 of this Report. These risks include,
but are not limited to, the following:

 Company shareholders may not realize a benefit from the ENTADFI or
 Proteomedix ("Proteomedix") acquisitions commensurate with the ownership dilution they have experienced in connection
 with the transactions.

 We may fail or elect not to commercialize our product.

 Disruptions to or significantly increased costs associated with transportation
 and other distribution channels for Proclarix may adversely affect our margins and profitability.

 Proclarix is subject to competition from other prostate cancer diagnostics
 and larger, well-established companies with substantially greater resources than us.

 We may not be able to successfully implement our strategy to grow sales of Proclarix in the European market or other markets, if authorized, grow sales in the United States market.

 We have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

 We have incurred significant net losses since inception, have only generated minimal revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability. Our stock is a highly speculative investment.

 We depend entirely on the success of a single product. If we do not successfully commercialize our product or we experience significant delays in doing so, this product may not be profitable.

 There is substantial doubt about our ability to continue as a "going concern," and we will require significant additional capital to make the investments we need to execute our business plan. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate commercialization efforts or certain operations, and we may be unable to continue as a going concern in the long term. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us.

 We may not be able to gain and retain market acceptance for our product.

 We expect to rely on third party manufacturers for Proclarix.

 It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product, others could compete against us more directly, which would harm our business, possibly materially.

 The market price of our common stock has been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their investment.

 iv

 There can be no assurance that we will be able to comply with the continued listing requirements of, and remain trading on, the Nasdaq Stock Market, LLC ("Nasdaq").

 We are an "emerging growth company" and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

 Our amended and restated certificate of incorporation ("Amended and Restated Certificate of Incorporation") and our amended and restated bylaws ("Amended and Restated Bylaws"), and Delaware law may have anti-takeover effects that could discourage, delay, or prevent a change in control, which may cause our stock price to decline.

 A possible "short squeeze" due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.

 We may have violated Section 13(k) of the Exchange Act of 1934, as amended ("Exchange Act") (implementing Section 402 of the Sarbanes-Oxley Act of 2002) and may be subject to sanctions as a result.

 Misconduct and errors by our current and former employees and our third-party service providers could cause a material adverse effect on our business and reputation.

 We may consider strategic alternatives in order to maximize stockholder value, including financing, strategic alliances, licensing arrangements, acquisitions or the possible sale of our business. We may not be able to identify or consummate any suitable strategic alternatives and any consummated strategic alternatives may not be successful.

 If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. We have identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated, or that additional material weaknesses will not occur in the future.

 The issuance or conversion of securities would result in significant dilution in the equity interest of existing shareholders and adversely affect the marketplace of the securities.

 If completed, the Ocuvex Business Combination may not achieve its intended results and may result in us assuming unanticipated liabilities.

 The transactions contemplated by the Ocuvex LOI are subject to conditions that may not be satisfied on a timely basis or at all. Failure to complete the transactions contemplated by the Ocuvex LOI could have material and adverse effects on us.

 We will be subject to business uncertainties while the Ocuvex Business Combination is pending, which could adversely affect our business.

 We expect to incur significant transaction costs in connection with the Ocuvex Business Combination.

 v

 Item 1. Business

 Company Overview

 We are a commercial stage biotechnology company
focused on the research, development, and commercialization of innovative solutions for men's health and oncology. Through our recent
acquisition of Proteomedix, we own Proclarix, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and
approved for sale in the European Union under the In Vitro Diagnostic Regulation ("IVDR"), which we anticipate will be marketed
in the U.S. as a lab developed test through our license agreement with LabCorp. We also own ENTADFI, an FDA-approved, once daily pill
that combines finasteride and tadalafil for the treatment of BPH, a disorder of the prostate.

 Proclarix is an easy-to-use next generation protein-based
blood test that can be done with the same sample as a patient's regular Prostate-Specific Antigen ("PSA") test. The
PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample. A high level
of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections, prostate
stimulation, vigorous exercise or even certain medications. PSA results can be confusing for many patients and even physicians. It is
estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment
that impacts the physician's routine, our healthcare system, and the quality of patients' lives. Proclarix helps doctors and
patients with unclear PSA test results through the use of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic
support for further treatment decisions. No additional intervention is required, and results are available quickly. Local diagnostic laboratories
can integrate this multiparametric test into their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay
(ELISA) standard, which most diagnostic laboratories are already equipped to process.

 In light of (i) the time and resources needed
to continue pursuing commercialization of ENTADFI, and (ii) the Company's cash runway and indebtedness, the Company has abandoned
commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI
assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other
transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.

 We rely and will continue to rely on third parties
for the manufacturing of Proclarix. We have no internal manufacturing capabilities, and we will continue to rely on third parties, of
which the main suppliers are single-source suppliers, for commercial products.

 We do not have any products approved for sale,
aside from Proclarix, from which we have generated revenue since acquisition, and ENTADFI, from which we have not generated any revenue
from product sales, and for which we have now abandoned commercialization activities. To date, we have financed our operations primarily
with proceeds from our sale of preferred securities to seed investors, the initial public offering ("IPO"), and subsequent
offerings of debt and equity securities. We will continue to require significant additional capital to commercialize Proclarix and to
fund operations for the foreseeable future. Accordingly, until such time as we can generate significant revenue, if ever, we expect to
finance our cash needs through public or private equity or debt financings, third-party (including government) funding and to rely on
third-party resources for marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing
arrangements, or any combination of these approaches, to support our operations.

 We have incurred net losses since inception and
expect to continue to incur net losses in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and
year-to-year, depending in large part on the timing of our preclinical studies, clinical trials and manufacturing activities, our expenditures
on other research and development activities and commercialization activities. As of December 31, 2024, the Company had a working capital
deficit of approximately $17.3 million and an accumulated deficit of approximately $113.0 million. We will need to raise additional capital
within the next 12 months to sustain operations.

 Until we generate revenue sufficient to support
self-sustaining cash flows, if ever, we will need to raise additional capital to fund our continued operations, including our product
development and commercialization activities related to our current and future products. There can be no assurance that additional capital
will be available to us on acceptable terms, or at all, or that we will ever generate revenue sufficient to provide self-sustaining cash
flows. These circumstances raise substantial doubt about our ability to continue as a going concern. The accompanying consolidated financial
statements of Onconetix, as of and for the year ended December 31, 2024, included elsewhere in this Report do not include any adjustment
that might be necessary if the Company is unable to continue as a going concern.

 Because of the numerous risks and uncertainties
associated with our business, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve
or maintain profitability. Additionally, even if we are able to generate revenue from Proclarix, we may not become profitable. If we fail
to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at
planned levels and may be forced to reduce our operations.

 On April 30, 2025, Proteomedix, in accordance
with Swiss law, provided notice to three employees that their respective employment relationships will end on July 31, 2025. This change
is not expected to significantly impact operations.

 Potential Ocuvex Transaction

 On April 1, 2025, the
Company and Ocuvex Therapeutics, Inc. ("Ocuvex") signed a Non-Binding Letter of Intent (the "Ocuvex LOI") contemplating
a potential business combination transaction with Ocuvex, pursuant to which the Company will acquire all the issued and outstanding equity
interests of Ocuvex in exchange for newly issued shares of common stock of the Company. Immediately following the closing of the proposed
transaction, the pre-closing Ocuvex equity holders will own approximately 90% of the equity interests in the combined company.

 The Ocuvex LOI only represents
a mutual indication of interest regarding the proposed transaction, and the terms of such transaction are subject to a number of contingencies,
including the completion of customary due diligence and the negotiation and execution of definitive agreements. Upon execution of the
definitive agreement, the completion of the transaction will be subject to, among other matters, satisfaction of the conditions negotiated
therein, the buyer having secured adequate financing, and receipt of all third party (including governmental) approvals, licenses, consents,
and clearances, as and when applicable.

 Management and History

 Onconetix, Inc. (formerly Blue Water Vaccines
Inc. and Blue Water Biotech, Inc.) was founded in October 2018. The Company's initial goal was to develop a transformational universal
flu vaccine to treat and prevent infections in patients globally. After deprioritizing our vaccine programs, the Company subsequently
shifted its focus toward building a foundation of therapeutic, diagnostic, and service products in the field of men's health and
oncology.

 Karina M. Fedasz, our Interim Chief Financial
Officer since June 2024, was appointed as Interim Chief Executive Officer on April 2, 2025. For more than two decades, Ms. Fedasz has
helped companies raise capital, model and forecast business, manage cash flow and conduct mergers and acquisitions. She is a dynamic,
data-driven executive with a bold, high-growth mindset. From January 2023 to June 2024, Ms. Fedasz worked with various clients, including
a not-for-profit and an early-stage artificial intelligence and data-driven health and wellness tracker. From February 2022 to December
2022, Ms. Fedasz served as Head of Business Development for Evofem Biosciences, a Nasdaq-listed public biotech company developing innovative
products for women's health. From August 2019 to October 2021, Ms. Fedasz served in various positions of increasing responsibility, including
Chief Financial Officer, at IDW Media Holdings, a micro-cap media company, where she managed the company's initial public offering. From
April 2018 to August 2019, Ms. Fedasz served as Chief Financial Officer of MOCEAN, an integrated agency for entertainment, gaming, and
brands. Ms. Fedasz's breadth of experience has seen her lead teams in media, technology, services, manufacturing, and education, and she
has worked with companies whose clients and customers include Fortune 500 companies such as Netflix, Disney, Amazon, Apple, Activision,
and EA. Ms. Fedasz received an MBA with an emphasis in finance from Columbia Business School and a BA from University California at Los
Angeles (UCLA). She holds an inactive CPA in the state of California.

 Additionally, members of our board of directors
("Board") have extensive expertise in the fields of life sciences, business and finance. Our directors include Andrew Oakley,
who had held several CFO positions at publicly-traded pharmaceutical companies, Simon Tarsh, a retired Deloitte Consulting managing director
with experience in life sciences, Ajit Singh, a partner at a Silicon Valley-based fund, and Timothy Ramdeen, who has nearly a decade of
experience in private equity and hedge fund investing, capital markets, and company formation.

 Nasdaq Compliance

 On January 24, 2025, the Company received a letter
from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of the Company's Common Stock
from November 25, 2024 to January 10, 2025, the Company is no longer in compliance with the requirement for continued listing on The Nasdaq
Capital Market to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the "Minimum
Bid Price Rule"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq provided the Company with 180 calendar days to regain
compliance with the Minimum Bid Price Rule.

 On April 14, 2025, Nasdaq issued a further notice
(the "Notice") to the Company that it determined that the Company's securities had a closing bid price of $0.10 or less
for ten consecutive trading days. Accordingly, the Company is subject to the provisions under Nasdaq Listing Rule 5810(c)(3)(A)(iii).
As a result, unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the "Panel"), trading of the
Common Stock would be suspended at the opening of business on April 23, 2025, and a Form 25-NSE would be filed with the SEC, which would
remove the Company's securities from listing and registration on Nasdaq. On May 27, 2025, the Company appeared before the Nasdaq
Hearings Panel and requested a stay of suspension. The Panel's decision about the stay request is still pending as of the date these
financials were filed.

 On April 24, 2025, the Company received an additional
deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq's continued listing standards as set forth in Listing
Rule 5250(c)(1) given the Company's failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31,
2024, and that this matter serves as an additional basis for delisting the Company's securities from Nasdaq. As the Company was
already before a Panel for its failure to comply with Minimum Bid Price Rule, the Company had seven calendar days from the date of the
Notice, or until May 1, 2025, to request a stay of the suspension, which request would stay the suspension of the Company's securities
pending the Panel's decision. The Company submitted a stay request on or before May 1, 2025.

 On May 20, 2025, the Company received an additional
deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq's continued listing standards as set forth in Listing
Rule 5250(c)(1) given the Company's failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025,
and that this matter serves as an additional basis for delisting the Company's securities from Nasdaq. The Company had seven calendar
days from the date of the Notice, or until May 27, 2025, to request a stay of the suspension, which would stay the suspension of the Company's
securities pending the Panel's decision. On May 27, 2025, the Company appeared before the Nasdaq Hearings Panel and requested a
stay of suspension. The Panel's decision about the stay request is still pending as of the date these financials were filed.

 However, there are no assurances that the Panel will grant the Company's
request for continued listing or an extension to demonstrate compliance. If the Company does not obtain a favorable decision from the
Panel, its Common Stock will become subject to delisting.

 Acquisitions

 Proteomedix

 On December 15,
2023, Onconetix entered into a Share Exchange Agreement (the "Share Exchange Agreement"), by and among (i) Onconetix,
(ii) Proteomedix, (iii) each of the holders of outstanding capital stock, convertible securities, or stock options of Proteomedix
named therein (collectively, the "Sellers") and (iv) Thomas Meier, in the capacity as the representative of Sellers in
accordance with the terms and conditions of the Share Exchange Agreement.

 Pursuant to the Share
Exchange Agreement, subject to the terms and conditions set forth therein, the Sellers agreed to sell to Onconetix, and Onconetix
agreed to buy, all of the issued and outstanding voting equity interests of Proteomedix in exchange for newly issued shares of Common
Stock and newly issued shares of Series B Preferred Stock (the "Share Exchange").

 The consummation of the
Share Exchange (the "Share Exchange Closing") was subject to customary closing conditions and the execution of the Subscription
Agreement entered into with Altos Ventures, a shareholder of Proteomedix prior to the closing of the Share Exchange (the "PMX Investor"). The
Share Exchange closed on December 15, 2023 (the "Share Exchange Closing Date"). The closing of the acquisition of Proteomedix
for all stock consideration provided Proteomedix shareholders with an initial 16.4% ownership stake of Onconetix, and Series B Preferred
Stock convertible into 6,741,820 shares of Onconetix Common Stock, subject to Onconetix stockholder approval of the same ("Stockholder
Approval"). On September 5, 2024, at the annual stockholders' meeting of the Company, the Company obtained the requisite
Stockholder Approval from Onconetix stockholders. On September 24, 2024, all outstanding shares of Series B Preferred Stock converted
into an aggregate of 6,741,820 shares of Onconetix Common Stock.

 Founded in 2010, Proteomedix
develops, markets and sells non-invasive diagnostic tests accompanied by decision support systems to detect and assess the prognosis
of cancer. Proteomedix's lead product, Proclarix, is an in vitro diagnostic test for prostate cancer. Proteomedix
is working to address all stages in cancer management by developing tools for both more accurate detection and more efficient treatment
of cancer including (i) diagnostic tests to early detect and define the stage of cancer; (ii) prognostic tools for the identification
of patients with aggressive disease; and (iii) stratification biomarkers to match patients with therapies that are more likely to be safe
and effective.

 Currently, prostate cancer
stands as the most prevalent and second most fatal cancer type affecting men. The widespread utilization of PSA screening since it became
broadly available in the 1980s helped reduce the occurrence of metastatic prostate cancers by over half, but also led to a notable increase
in overdiagnosis, sometimes resulting in excessive treatment, severe complications, and potential psychological distress. There exists
a considerable population of men each year who are notified of their heightened risk for prostate cancer based on elevated PSA levels,
with limited options beyond invasive needle biopsies for managing their cancer risk.

 Proclarix addresses the
unsolved problem of prostate cancer overdiagnosis, which can lead to negative prostate biopsies that increase costs for the healthcare
system and uncertainty for patients. Proclarix is approved for sale in the European Union under the IVDR. Proclarix was first CE marked
under the IVD Directive in Europe on January 31, 2019. On October 7, 2022, Proclarix gained CE marking under the IVD Regulation (IVDR)
and was registered in the United Kingdom and Switzerland under applicable regulations. Clinical studies have confirmed that Proclarix
accurately identifies clinically significant prostate cancer through a risk score derived from a clinical decision support system and
could help avoid many unneeded biopsies. Proclarix as a clinical support system is designed to aggregate multimodal information in an
effort to develop a patient-centric diagnostic approach. We intend to add more information to the risk score in the future, such as other
biomarkers or magnetic resonance imaging data, to provide an even more powerful tool to guide the patient's diagnostic journey.
The markers and the bioinformatics algorithm used are patent-protected.

 The
guidelines of the European Association of Urology ("EAU") and of the American Urological Association/Society of Urologic Oncology
("AUA/SUO") both recommend the use of blood-based biomarker tests, such as Proclarix, to aid in the early detection and evaluation
of prostate cancer. Proclarix can be performed in any laboratory using standard equipment. Proteomedix announced commercial availability
of Proclarix in Europe on February 26, 2020 and began marketing Proclarix to selected pilot laboratories offering Proclarix in Switzerland,
Germany, Italy and the United Kingdom. Proclarix is currently not reimbursed in Europe, and therefore patients pay for Proclarix out of
pocket. The number of sold Proclarix tests current corresponds to the early market development stage and selected few laboratories offering
Proclarix. In 2024, we had revenues of $86,957 from sales of Proclarix. Prior to being acquired by Onconetix in 2023, Proteomedix had
$67,380 from sales of Proclarix. In the United States, the development and commercialization of Proclarix is being pursued by Laboratory
Corporation of America Holdings, more commonly called LabCorp, pursuant to an exclusive license agreement entered into between Proteomedix
and LabCorp in 2023.

 Proteomedix was founded
by a multi-disciplinary group of scientists and clinicians that include Prof. Emeritus Dr. Thomas Cerny, president of the Swiss Cancer
Research Foundation, Prof. Ruedi Aebersold, a pioneer in proteomics technology development, and the late Prof. Wilhelm Krek, a leader
in cancer research. Proteomedix's management consists of Dr. Ralph Schiess (Chief Executive Officer), who developed the biomarker
technology, and Christian Br hlmann (Chief Business Officer), with seasoned experience in finance, business development and product
management. On February 18, 2025, Christian Br hlmann resigned from his position as Chief Strategy Officer of the Company. Mr. Br hlmann
will remain in his position as Chief Business Officer of Proteomedix. On February 24, 2025, Dr. Schiess resigned from his positions as
the Interim Chief Executive Officer of the Company and Chief Science Officer of Proteomedix, effective immediately, and from his position
as Chief Executive Officer of Proteomedix, effective May 31, 2025.

 Terms of the PMX Transaction

 Consideration

 Pursuant to the Share
Exchange Agreement, on December 15, 2023, in full payment for the Purchased Shares, Onconetix issued shares (the "Exchange Shares")
consisting of: (i) 91,885 shares of Common Stock equal to approximately 19.99% of the total issued and outstanding Common Stock prior
to the acquisition and (ii) 2,696,729 shares of Series B Preferred Stock convertible into 6,741,820 shares of Common
Stock. The parties agreed that the aggregate value of the Exchange Shares at the Share Exchange Closing was equal to approximately Seventy-Five
Million U.S. Dollars ($75,000,000) (the "Exchange Consideration") less the value of the Proteomedix Shares for which the Proteomedix
Stock Options (as defined below) are exercisable immediately prior to the Share Exchange Closing, subject to adjustment for indemnification
as described below. Following the Share Exchange Closing, 571,049 and 558,114 shares of Common Stock were issued and outstanding, respectively.

 The fair value of the
91,885 shares of Common Stock, was determined using the closing price of the Common Stock as of the Share Exchange Closing Date,
which was $9.528. The fair value of the 2,696,729 shares of Series B Preferred Stock was based on the underlying fair value of the
common shares issuable upon conversion, also based on the closing price of the Common Stock as of the Share Exchange Closing Date. The
aggregate fair value of the common and preferred shares issued as consideration was equal to approximately $65.1 million.

 Tungsten Advisors acted
as financial advisor to Proteomedix at Proteomedix's expense. As part of compensation for services rendered by Tungsten Advisors,
the parties agreed that $7,500,000 in Exchange Shares were issued to certain affiliates of Tungsten Advisors (the "Advisor Parties")
out of the total Exchange Consideration issued by Onconetix.

 As a result of the PMX
Transaction, Proteomedix became a direct, wholly owned subsidiary of Onconetix. Immediately following the Conversion (as defined below)
and closing of the investment pursuant to the Subscription Agreement (as defined below), Sellers owned approximately 87.2% of the outstanding
equity interests of Onconetix, the PMX Investor owned approximately 7.5% of the outstanding equity interests of Onconetix, and the stockholders
of Onconetix immediately prior to the Share Exchange Closing owned approximately 5.3% of the outstanding equity interests of Onconetix.

 Each option to purchase
shares of Proteomedix (each, a "Proteomedix Stock Option") outstanding immediately before the Share Exchange Closing, whether
vested or unvested, remained outstanding until the Conversion unless otherwise terminated in accordance with its terms. At the Conversion,
each outstanding Proteomedix Stock Option, whether vested or unvested, was assumed by Onconetix and converted into the right to receive
(a) an option to acquire shares of Common Stock (each, an "Assumed Option") or (b) such other derivative security as Onconetix
and Proteomedix agreed, subject in either case to substantially the same terms and conditions as were applicable to such Proteomedix Stock
Option immediately before the Share Exchange Closing. Each Assumed Option: (i) represented the right to acquire a number of shares of
Common Stock equal to the product of (A) the number of Proteomedix Common Shares that were subject to the corresponding Proteomedix Option
immediately prior to the Share Exchange Closing, multiplied by (B) the Exchange Ratio (as defined in the Share Exchange Agreement); and
(ii) had an exercise price (as rounded down to the nearest whole cent) equal to the quotient of (A) the exercise price of the corresponding
Proteomedix Option, divided by (B) the Exchange Ratio.

 From and
after the Share Exchange Closing and until the first anniversary of the Share Exchange Closing, Sellers, severally and not jointly, are
required to indemnify Onconetix and its affiliates and their respective representatives (collectively, the "Onconetix Indemnitees")
against (i) any inaccuracy in or breach of any of the representations or warranties of such Seller contained in the Share Exchange
Agreement and (ii) breach or non-fulfillment of any covenant, agreement or obligation to be performed by such Seller pursuant
to the Share Exchange Agreement. Any payment due from any Seller in respect of an indemnification claim by any Onconetix Indemnitee shall
solely be satisfied by recourse to the Exchange Shares and the shares of Common Stock issuable upon the Conversion, with each share of
Common Stock valued at the same price per share of Common Stock used to determine the Exchange Ratio.

 Lock-Up Agreement

 Simultaneously with the
execution of the Share Exchange Agreement, the Sellers and the Advisor Parties, as shareholders of Proteomedix, entered into Lock-Up Agreements
(each, a "Lock-Up Agreement"). Pursuant to each Lock-Up Agreement, each signatory thereto will agree not to, during the period
commencing from the Share Exchange Closing Date and ending on the 6-month anniversary of the date of Stockholder Approval: (i) lend,
offer, pledge, hypothecate, encumber, donate, assign, sell, contract to sell, sell any option or contract to purchase, purchase any option
or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, the
Exchange Shares or the Conversion Shares, (ii) enter into any swap or other arrangement that transfers to another, in whole or in
part, any of the economic consequences of ownership of the Exchange Shares or the Conversion Shares, or (iii) publicly disclose the
intention to do any of the foregoing, whether any such transaction described in clauses (i), (ii) or (iii) above is to be settled by delivery
of the Exchange Shares or the Conversion Shares or other securities, in cash or otherwise (subject to certain exceptions).

 Non-Competition and Non-Solicitation Agreement

 Simultaneously with the
execution of the Share Exchange Agreement, certain executive officers (each, a "Management Shareholder") of Proteomedix each
entered into a non-competition and non-solicitation agreement (collectively, the "Non-Competition and Non-Solicitation Agreements")
with Onconetix. Under the Non-Competition and Non-Solicitation Agreements, each Management Shareholder agreed not to compete with Proteomedix,
and after the Share Exchange Closing, Onconetix, and their respective affiliates during the three-year period following the Share Exchange
Closing and, during such three-year restricted period, not to solicit employees or customers of such entities. Each Non-Competition and
Non-Solicitation Agreement also contains customary confidentiality and non-disparagement provisions.

 Stockholder Support Agreement

 Simultaneously with the
execution of the Share Exchange Agreement, Onconetix, Proteomedix and certain directors of Onconetix who are stockholders of Onconetix,
entered into a Stockholder Support Agreement (the "Stockholder Support Agreement"), pursuant to which, among other things,
each such stockholder of Onconetix has agreed (a) to support the adoption of the Share Exchange Agreement and the approval of the PMX
Transaction, subject to certain customary conditions, and (b) not to transfer any of their subject shares (or enter into any arrangement
with respect thereto), subject to certain customary conditions.

 Stockholder Subscription Agreement and Debenture

 In connection with the PMX Transaction, on December
18, 2023, Onconetix entered into a Subscription Agreement (the "Subscription Agreement") with the PMX Investor for a private
placement of $5.0 million of units (the "Units"), each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded
warrant (collectively, the "Warrants") to purchase 0.3 shares of Common Stock at an exercise price of $0.04 per share, for
an aggregate purchase price per Unit of $10.00 (the "Purchase Price"). Additional shares are issuable to the PMX Investor
to the extent the PMX Investor continues to hold Common Stock included in the Units and if the VWAP during the 270 days following the
Share Exchange Closing is less than the Purchase Price, as set forth in the Subscription Agreement.

 On January 23, 2024, the Company issued a non-convertible
debenture (the "Altos Debenture") to the PMX Investor in the principal sum of $5.0 million, the payment of which shall offset
the $5.0 million subscription amount for the Units pursuant to the Subscription Agreement.

 The Altos Debenture had
an interest rate of 4.0% per annum, and the principal and accrued interest was originally repayable in full upon the earlier of (i) the
closing under the Subscription Agreement and (ii) June 30, 2024. Additionally, the $5.0 million subscription amount under the Subscription
Agreement shall be increased by the amount of interest payable under the Altos Debenture.

 On April 24, 2024, the Altos Debenture was amended
to extend the maturity date to the earlier of (i) the closing under the Subscription Agreement and (ii) October 31, 2024 (the
"Altos Amendment"). On September 24, 2024, upon obtaining stockholder approval and pursuant to the Subscription Agreement,
the Company issued an aggregate of 513,424 units (the "Units") to Altos, each Unit comprised of (i) one share of Common Stock
and (ii) one pre-funded warrant (collectively, the "Altos Warrants") to purchase 0.3 shares of Common Stock at an exercise
price of $0.04 per share. The Altos Warrants were immediately exercisable at any time on or after the date of issuance and had a term
of exercise of five (5) years from the date of issuance. The outstanding debt, as per the Altos Debenture agreement, is considered settled
through the unit issuance.

 Additional shares are issuable to Altos to the
extent Altos continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than $10.00,
as set forth in the Subscription Agreement.

 On September 24, 2024, Altos exercised all the
Altos Warrants, and the Company issued to Altos an additional 154,027 shares of Common Stock upon such exercise.

 ENTADFI

 On April 19, 2023, the Company entered into
an asset purchase agreement with Veru Inc., a Wisconsin corporation ("Veru") (the "Veru APA"). Pursuant to, and
subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets related to Veru's ENTADFI business.
The transaction closed on April 19, 2023.

 The Company purchased substantially all of Veru's
assets, rights and property related to ENTADFI for a total possible consideration of $100.0 million (as described below). The acquisition
of ENTADFI capitalizes on the demonstrable success of the FDA-approved drug ENTADFI for treating benign prostatic hyperplasia and
counteracting negative sexual side effects seen in men on alternative BPH therapies.

 Pursuant to the terms of the Veru APA, the Company
agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the
transaction, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) an
additional $10.0 million in the form of two equal (i.e. each for $5.0 million) non-interest bearing notes payable, each due on April 19,
2024 and September 30, 2024. On April 24, 2024, Veru agreed to forbear its rights and remedies until March 31, 2025, which forbearance
period was further extended until June 30, 2025 by limited waiver on March 31, 2025 and April 24, 2025, with respect to, among other things,
our inability to pay amounts due on April 19, 2024, and on September 19, 2024, Veru agreed to forbear its rights and remedies until June
30, 2025 with respect to, among other things, our inability to pay amounts due on September 30, 2024. In addition, on November 26, 2024,
the Company and Veru entered into a waiver and amendment to the forbearance agreement, pursuant to which Veru agreed to waive the due
date for payment of applicable Company cash receipt payments generated in October 2024 in consideration for an increase in payments to
be made to Veru out of future financing and strategic transactions through June 30, 2025.

 On September 29, 2023, the Company entered into
an amendment (the "Veru Amendment") of the Veru APA. Pursuant to the Veru Amendment, the $4.0 million note payable originally
due on September 30, 2023 was deemed paid and fully satisfied upon (1) the payment to Veru of $1.0 million in immediately available funds
on September 29, 2023, and (2) the issuance to Veru by October 3, 2023 of 3,000 shares of Series A Preferred Stock of the Company, which
converted in to 142,749 shares of Common Stock on September 24, 2024.

 Additionally, the terms of the Veru APA require
the Company to pay Veru up to an additional $80.0 million based on the Company's net sales from the ENTADFI business after
closing. The Milestone Payments are payable as follows: (i) $10.0 million is payable if the Company's annual net sales from
the ENTADFI business equal or exceed $100.0 million, (ii) $20.0 million is payable if the Company's annual net sales from
the ENTADFI business equal or exceed $200.0 million, and (3) $50.0 million is payable if annual net sales from the ENTADFI business
equal or exceed $500.0 million. No more than one Milestone Payment shall be made for the achievement of each net sales milestone. There
can be no assurance that the net sales milestones for payment of any of the Milestone Payments will be reached.

 Furthermore, in connection with the transaction,
the Company assumed royalty and milestone obligations under an asset purchase agreement for tadalafil-finasteride combination entered
into by Veru and Camargo Pharmaceutical Services, LLC on December 11, 2017. The Camargo Obligations assumed by the Company include a 6%
royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $22.5 million as follows: (i) $5.0 million is
payable upon the first time the Company achieves net sales from ENTADFI of $100.0 million during a calendar year, (ii) $7.5 million
is payable upon the first time the Company achieves net sales from ENTADFI of $200.0 million during a calendar year, and (3) $10.0 million
is payable upon the first time the Company achieves net sales from ENTADFI of $300.0 million during a calendar year.

 In light of (i) the time and resources needed
to continue pursuing commercialization of ENTADFI, and (ii) the Company's cash runway and indebtedness, the Company has abandoned
commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI
assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other
transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product. In addition, as part of cost reduction
efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three employees involved with the ENTADFI program,
effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting basis. Based on the
current circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired.

 WraSer

 On June 13, 2023 (the "Execution Date"),
the Company entered into an asset purchase agreement with the WraSer Seller and Parent (the "WraSer APA"). Pursuant to, and
subject to the terms and conditions of, the WraSer APA, on the WraSer Closing Date (as defined below) the Company will purchase six FDA-approved
pharmaceutical assets across several indications, including cardiology, otic infections, and pain management (the "WraSer Assets").

 Under the terms of the WraSer APA, the Company
will purchase the WraSer Assets for (i) $3.5 million in cash at signing of the WraSer APA (the "Signing Cash"); (ii) $4.5
million in cash on the later of (x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the
WraSer APA are met or otherwise waived (the "WraSer Closing Date"); (iii) 1.0 million shares of the Company's common
stock (the "Closing Shares") issuable on the WraSer Closing Date, and (iv) $500,000 in cash one year from the WraSer Closing
Date. The closing of the transaction is subject to certain customary closing conditions and the delivery to the Company of financial statements
of WraSer Seller and Parent for the fiscal years ended December 31, 2022 and 2021 audited by a qualified auditor reasonably acceptable
to the Company.

 Within 90 days of the WraSer Closing Date, the
Company will use its best efforts to file with the SEC, (at its sole cost and expense,) a registration statement to register on Form S-3
registering under the Securities Act, the resale of the Closing Shares and will use its best efforts to have the registration statement
declared effective as soon as practicable after filing.

 In conjunction with the WraSer APA, the Company
and the WraSer Seller entered into a Management Services Agreement (the "MSA") on the Execution Date. Pursuant to the terms
of the MSA, the Company was to act as the manager of the WraSer Seller's business during the period between the Execution Date and
WraSer Closing Date. During this period, the Company was to make advances to WraSer, if needed to sustain operations. The Company's
involvement as manager of the WraSer Seller's business ended when WraSer filed for relief under chapter 11 of the U.S. Bankruptcy
Code in the Bankruptcy Court (see below). If, on the WraSer Closing Date, the WraSer Seller's cash balance is in excess of the target
amount specified in the MSA of $1.1 million (the "Cash Target"), the Company was to apply that excess to the $4.5 million
cash payment due upon closing. Conversely, if there is a shortfall, the Company would have been required to remit the difference to the
WraSer Seller over time. Specifically, as the Company would have collected accounts receivable generated after the WraSer Closing Date,
the Company would have been required to remit 50% of the collections to the WraSer Seller until the shortfall is paid in full. The MSA
terminates on the WraSer Closing Date.

 The WraSer APA can be terminated prior to closing
as follows (i) upon agreement with all parties; (ii) upon breach of contract of either party, uncured within 20 days of notice. If the
WraSer APA is terminated upon agreement with all parties or upon uncured breach of contract by the WraSer Seller, the initial $3.5 million
payment is retained by the WraSer Seller. If it is determined that there is an uncured breach of contract by the WraSer Seller, and the
WraSer APA is terminated, the Company will have an unsecured claim against WraSer for the $3.5 million payment made by the Company upon
execution of the WraSer APA. The closing of the transaction was subject to various closing conditions, including submission of the FDA
transfer documentation to transfer ownership of the acquired product regulatory approvals to the Company.

 On September 26, 2023, WraSer and its affiliates
filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court.

 On October 4, 2023, the parties agreed to amend
the WraSer APA, subject to court approval. Shortly after its bankruptcy filing, WraSer filed a motion seeking approval of the WraSer APA
as amended. The amendment, among other things, eliminates the $500,000 post-closing payment due June 13, 2024 and staggers the $4.5 million
cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to
be paid in monthly installments of $150,000 commencing January 2024 (the "Post-Closing Payment") and (iii) 789 shares of Series
A Preferred Stock to be paid at closing. The amendment also reduced the number of products we were acquiring by excluding pain medications
and including only (i) Ciprofloxacin 0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL and its Authorized Generic
Version approved under US FDA NDA No. 208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark CETRAXAL, and (iii) Vorapaxar
Sulfate tablets under the trademark Zontivity approved under US FDA NDA N204886.

 In October 2023, WraSer alerted us that its sole
manufacturer for the active pharmaceutical ingredient ("API") for Zontivity, the key driver for the WraSer acquisition, would
no longer manufacture the API for Zontivity. We believe that this development constituted a Material Adverse Effect under the APA enabling
us to terminate the APA and MSA. On October 20, 2023, we filed a motion for relief from the automatic stay in the Bankruptcy Court to
exercise our termination rights under the WraSer APA, as amended. On December 18, 2023, the Bankruptcy Court entered an Agreed Order
lifting the automatic stay to enable us to exercise our rights to terminate the APA and the MSA without prejudice to the parties'
respective rights, remedies, claims, and defenses they had against one another under the APA and MSA. On December 21, 2023, we filed
a Notice with the Bankruptcy Court terminating the APA and MSA. WraSer has advised us that it does not believe that a Material Adverse
Event occurred. Due to the WraSer bankruptcy filing and our status as an unsecured creditor of WraSer, it is also unlikely that we will
recover the $3.5 million Signing Cash or any costs and resources in connection with services provided by the Company under the WraSer
MSA.

 Business of the Company

 Business Model

 Proteomedix develops novel diagnostic tests in
a highly regulated field. Proteomedix's core competencies include the development of high-quality immunoassays and management of
regulatory affairs. Our expertise in immunoassay development is the result of a highly specialized workforce that, together with an external
software development company, developed the proprietary software integrated in the company's lead IVD product, Proclarix. Our personnel
also have extensive experience in implementing and maintaining a state-of-the-art quality management system to comply with regulatory
requirements, including performing clinical studies and managing key opinion leaders ("KOLs"). Our experience and expertise
in these fields was obtained by hiring experienced personnel as well as through key advisors.

 Proteomedix is initially focusing on seeking to
license its intellectual property to third party laboratories. Sales will be through a specialized distributor and/or laboratory partner,
but Proteomedix will still provide technical customer support to laboratories that offer the testing service to physicians. Proteomedix
does not have production capabilities built up in-house, and instead outsources manufacturing to a CMO in Germany. All of the key reagents
used in Proteomedix's IVD kits (i.e., antigens and antibodies) are proprietary and owned exclusively by Proteomedix, which uses
an independent supplier in Germany to produce these reagents and supply them to its CMO.

 Proclarix

 Proteomedix is seeking to develop diagnostic,
prognostic and predictive tools to enable more efficient cancer management at all stages of disease progression. Proteomedix's tests
use proprietary protein biomarkers to address the limitations in current cancer detection, prognosis, and therapy prediction. In addition,
Decision Support Systems support the clinical decision-making by integrating different inputs in a risk score (see Figure 1).

 Figure 1: Product Pipeline

 Proclarix

 Proclarix

 Proclarix is used to indicate the risk of clinically
significant prostate cancer through a risk score derived from a clinical decision support system (Figure 2). On the reagent side it is
comprised of two quantitative Enzyme-linked Immunosorbent Assays ("ELISA") that measure the concentration of thrombospondin
1 ("THBS1") and cathepsin D ("CTSD") in human serum. The clinical decision support system is a web-based software
running a proprietary algorithm that integrates the values for THBS1 and CTSD, the patient's age and total and free PSA levels from
third party providers (e.g., Roche Diagnostics, Siemens Healthineers) to calculate a risk score.

 Figure 2: Proclarix: Assays and software algorithm for risk
score calculation.

 Proclarix is used as an aid in prostate cancer
diagnosis as a second-line test after PSA and DRE testing. It enables a personalized decision for each patient based on objective risk
parameters (4 serum glycoproteins + age) to triage between biopsy or a monitoring approach. Proclarix has been validated and approved
for use in men with elevated total PSA (2.0 to 10.0 ng/mL), a normal DRE not suspicious for cancer and an elevated prostate volume ( 35
mL) (Figure 3). The Proclarix decision support tool returns a risk score that can be used as an aid in discriminating between clinically
significant (grade group 2 or higher [GG2+]) and insignificant prostate cancer or benign prostate disease. The risk score of Proclarix
gives the physician and patient actionable information to confidently make decisions when considering the necessity of a prostate biopsy
which is required for diagnosis of prostate cancer.

 Figure 3: Proclarix: Finding clinically significant prostate
cancer in the diagnostic "grey zone."

 Clinical Studies

 Proteomedix's biomarkers have been tested
in clinical studies including a total of more than 2,000 patient samples from multiple clinical sites, and results have been published
in peer-reviewed journals. We believe these results demonstrate that Proclarix is a valuable test identifying clinically significant prostate
cancer thereby facilitating informed decision making for patients considering a prostate biopsy.

 Validation Study. The study leading to
the granting of regulatory approval in Europe included 955 samples collected at two clinical sites, a screening center in Innsbruck, Austria,
as well as a referral center in Hamburg, Germany. The results of this study demonstrated that by using the Proclarix test the burden of
unneeded biopsies could have been lowered by approximately 43% — twice as much compared to clinical comparators percent free PSA
("%fPSA") or PSA density. High sensitivity of 90% and a negative predictive value of 95% for clinically significant prostate
cancer indicated that the diagnosis of very few cancers would have been delayed.

 PROPOSe Study. The PROPOSe study evaluated
the accuracy of Proclarix in prostate biopsy decision making. Ten clinical sites in Germany, Denmark and Austria prospectively enrolled
457 men presenting for prostate biopsy. Proclarix detected clinically significant cancer with high sensitivity above 90% and reliably
ruled out patients with no or indolent cancer with a negative predictive value greater than 90%. When the biopsy performed was guided
by magnetic resonance imaging ("MRI"), both sensitivity (97%) and negative predictive value (96%) were even higher. Importantly,
Proclarix was significantly superior to the current clinical standard, %fPSA, in ruling out unneeded biopsies (22% vs. 14%) and the primary
study endpoint was met (p-value < 0.005).

 Naples Study. A two-center study evaluated
Proclarix and the Prostate Health Index (phi) test from Beckman Coulter, Inc. for predicting clinically significant prostate cancer in
a total of 344 men. Both Proclarix and the phi test accurately predicted clinically significant cancer. When using predefined cut-offs
recommended by the manufacturers, Proclarix (cut-off 10) outperformed phi (cut-off 27) in terms of specificity and positive predictive
value (p < 0.002) at similar sensitivities.

 Clinical evaluation of Proclarix. Results
of multiple clinical evaluations using Proclarix together with MRI for prostate cancer diagnosis showed that Proclarix can be used in
a broad range of patients without the need for prostate volume restriction. The aim of one such evaluation was the assessment of the diagnostic
performance of Proclarix in combination with MRI. Blood samples from 721 men undergoing MRI followed by biopsy at two clinical centers
were analyzed. The combined Proclarix-MRI score's specificity (68%) was significantly (p<0.001) better compared to Proclarix
(27%) or MRI (28%) alone for diagnosing clinically significant prostate cancer. Importantly, Proclarix by itself was found to be useful
in men with indetermined imaging results by outperforming PSA density in terms of specificity (25% vs 13%, p=0.004) at 100% sensitivity.
In another evaluation of a study of 517 men with suspected prostate cancer, Proclarix performed well in accurately diagnosing prostate
cancer in the overall study population and in a subset of men with elevated PSA 2 to 10 ng/mL, prostate volume 35 mL, and normal DRE
(n=281). In addition, a sub-analysis of was performed specifically analyzing 169 men with an indeterminate MRI result and Proclarix was
more accurate in selecting appropriate candidates for prostate biopsy when compared to PSA density and online risk calculators. A third
evaluation describes which patients with suspected prostate cancer can benefit from Proclarix after MRI and concluded that Proclarix outperformed
PSA density in the selection of candidates for prostate biopsy, especially in men with PI-RADS 1-3. In these studies, Proclarix proved
to be effective before, after, and together with MRI assessment to identify men at risk of clinically significant prostate cancer and
those who can safely avoid biopsy. Proclarix in combination with MRI reliably predicted clinically significant prostate cancer and ruled
out men with no or indolent cancer.

 Clinical Guidelines

 Guidelines assist clinicians in making informed
treatment decisions, taking into account the available scientific data. To reduce the number of negative biopsies in asymptomatic men
with a PSA level between 3–10 ng/mL and a normal DRE, the EAU guidelines recommend using an online risk-calculator that is correctly
calibrated to the population prevalence, MRI of the prostate or an additional biomarker test such as Proclarix. The EAU guidelines specifically
state that Proclarix has been correlated with the detection of significant prostate cancer, notably in case of equivocal MRI results.

 Proclarix was also included in the 2023 AUA/SUO
clinical practice guideline. The AUA/SUO guideline covers recommendations on the early detection of prostate cancer and provides a framework
to facilitate clinical decision-making in the implementation of prostate cancer screening, biopsy, and follow-up. The AUA/SUO guideline
concludes that the evaluation of prostate cancer risk should be focused on the detection of clinically significant prostate cancer (GG2+).
The AUA/SUO guidelines advice that use of laboratory biomarkers such as Proclarix, prostate MRI, and biopsy techniques may improve detection
and safety when a prostate biopsy is deemed necessary following prostate cancer screening.

 The inclusion of Proclarix in the European and
U.S. guidelines is an important recognition of the clinical value of Proclarix. It serves as a validation for the clinical utility and
importance of using Proclarix in the detection of prostate cancer and we believe it will lead to broader acceptance of Proclarix and accelerate
payor adoption.

 Product Quality and Safety

 Proteomedix's quality management system
is ISO (International Organization for Standardization) 13485:2016 certified for the "Design and development, production and distribution
of in-vitro diagnostic reagents and stand-alone software for prostate cancer management". Proteomedix is annually audited by T V
S D Product Service GmbH, an internationally recognized notified body headquartered in Germany. ISO certification is a prerequisite
for obtaining CE-mark, the regulatory clearance requirement for market access, recognized by the European Commission ("EC")
in the IVDR. Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low risk)
to class D (highest risk). Proclarix, as class C device, was assessed by T V S D for conformity resulting in IVDR certification.
The certification of Proclarix under the new IVDR demonstrates compliance to the highest quality standard currently in force for tests
used in screening, diagnosis, or staging of cancer. Proteomedix is marketing Proclarix as one of the first IVDR compliant cancer tests
demonstrating the commitment to highest analytical and clinical performance.

 Prosgard

 Prosgard as a clinical support system is designed
to aggregate multimodal information in an effort to develop a patient centric diagnostic approach. The vision for Prosgard is to add more
information to the existing Proclarix risk score in the future such as other biomarkers, clinical information, or MRI imaging data to
provide an even more powerful tool to guide the patient's diagnostic journey.

 Prognosis (Px)

 A subset of Proteomedix's protein biomarkers
also correlate with prostate cancer prognosis. Radical prostatectomy provides excellent cancer control of clinically localized prostate
cancer. However, approximately 30% of surgically treated men will experience cancer recurrence within 10 years of surgery. Several clinical
parameters and the combination thereof (e.g., the Cancer of the Prostate Risk Assessment ("CAPRA") score) have been shown
to be reliable predictors of treatment failure. Still, there is a compelling need to identify novel markers that are specifically linked
to the presence of biologically aggressive prostate cancer for improved prediction of outcome in populations with moderately elevated
PSA levels.

 A novel serum biomarker quintet that improves disease prognosis
in men with confirmed prostate cancer

 A clinical evaluation of a multivariable model
comprising fibronectin 1, galectin-3-binding protein, lumican, matrix metalloprotease 9, thrombospondin-1 and PSA together with clinical
Grade Group (GG) and clinical stage (cT) was performed. The prognostic utility of the proposed marker combination was assessed in serum
samples from 557 men with confirmed localized prostate cancer. The analysis showed that the proposed model had a better prediction for
disease progression and thus prostate cancer aggressiveness compared to the "CAPRA" score. This novel biomarker test has the
potential to improve prostate cancer patient management by indicating who needs active treatment. In contrast to the existing biomarker
tests from competitors that all need tissue specimens, the test is non-invasive and can be directly measured in patients' blood
samples.

 Prediction (Rx)

 Proteomedix's protein biomarkers further
have the potential to predict the response of patients treated with drugs that inhibit the PI3K signaling pathway. Proteomedix analyzed
the blood of patients participating in a Phase II trial (SAKK 08/08). The patients were treated with Novartis AG's Everolimus, a
drug inhibiting the PI3K pathway signaling by blocking mTOR. A subset of 8 serum biomarkers could individually predict reaching the primary
endpoint (progression free survival at 12 weeks) with an accuracy of at least 75%.

 Decision Support Systems

 Recent initiatives are incorporating as well as
interpreting clinical information from various sources (e.g., biomarker information and other patient data) enabling physicians to have
more comprehensive biochemical insight into each patient's disease in order to determine the optimal treatment plan for the patient.
Collating multiple data sources in clinical workflows allows precision-medicine resulting in cost-effective diagnostics and therapies.
Proclarix already consists of a decision support system integrating different values in a risk score. In the future, additional clinical
information like the results of an MRI scan could be integrated in the report to provide a complete picture of the diagnostic situation
of the patient to enable effective patient management.

 Commercialization Strategy

 Proclarix

 Proclarix is currently not reimbursed in Europe,
and therefore patients pay for Proclarix out of pocket. We intend to pursue reimbursement from public and private payors in key European
markets to secure broad adoption in the longer term. The market introduction of Proclarix has followed a two-phased approach: first a
market preparation phase in which we reach out to key opinion leaders in selected European countries to solicit their support for Proclarix,
followed by a market development phase where we begin commercializing Proclarix in those markets with focused marketing and sales activities
to urologists and general practitioners. We intend to secure access to testing through partnerships with reference diagnostic labs. We
have initiated outreach to commercial laboratories and hospital laboratories that are routinely serving study sites and academic collaboration
partners, and have established pilots with laboratories in Switzerland, Germany, Italy, and the United Kingdom.

 In the United States, Proteomedix entered into
an exclusive partnership with LabCorp in 2023 pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix,
and other products developed by LabCorp using Proteomedix's intellectual property covered by the license, in the United States for
identification, screening, staging, predisposition, diagnosis, prognosis, monitoring, prevention or treatment selection with respect to
prostate cancer. In consideration for granting LabCorp an exclusive license, Proteomedix received an upfront license fee and is entitled
to royalty and milestone payments based upon sales of licensed products or services in the United States. LabCorp is wholly responsible
for the cost of research, development and commercialization of licensed products or services in the United States but has the right to
offset a portion of those costs against future royalty and milestone payments otherwise due to Proteomedix.

 Sales, Distribution, Marketing and Advertising

 In clinical diagnostics high throughput assay
parameters like PSA typically are performed on closed, fully integrated systems that use proprietary reagents. Integrated systems are
provided by a few mid-sized to large diagnostic companies (e.g., Roche Diagnostics, Abbott Laboratories, Siemens Healthineers AG, DiaSorin
S.p. A.) with a worldwide distribution network. Reagents are provided in a closed-system approach, access is through collaboration agreements
only. Business development discussions with multiple diagnostic companies have already started.

 Lower volume parameters are run on smaller, open
systems that are used in laboratories for tests with lower throughput to complement the test menu. Access to these open systems presents
an option for direct commercialization in selected markets during market introduction. First, the goal is to establish commercial proof
of concept and drive initial market adoption.

 Market adoption of a new test is driven by KOLs
and clinical urology centers. Publication of clinical studies proving the medical benefit of the test and KOLs advocating it at scientific
conferences will trigger the usage by other physicians. Additionally, demand is created through urology centers specialized in prostate
cancer that cover a large geographical area. Their influence on other urologists and general practitioners in the region will lead to
multiplier effects. Diagnostic testing in clinical urology centers is provided either by an in-house hospital laboratory or a commercial
laboratory where Proclarix will be implemented.

 General practitioners recruit patients for screening
and decide whether to refer a patient to a specialist. They have an important gatekeeper role and Proclarix is a helpful tool for this
triage. Marketing outreach of commercial laboratory networks (e.g., Unilabs, Switzerland; Sonic Healthcare, Australia; LabCorp, U.S.A.)
provides an opportunity to directly address the large number of general practitioners and urologists in private practices through their
specialized sales force.

 Market Opportunity

 Proclarix, the first diagnostic product of Proteomedix,
is addressing unmet medical needs related to prostate cancer, which is the second most frequently diagnosed cancer in men. There were
1,467,854 new cases of prostate cancer and 397,430 prostate cancer related deaths worldwide in 2022 according to World Cancer Research
Fund International.

 The PSA test represents the current standard of
care in prostate cancer diagnosis. It accurately identifies individuals with no sign of disease. Approximately 10% of all men have elevated
PSA levels, commonly referred to as the diagnostic "grey zone", of which only 20-40% present clinically with cancer. Proclarix
is intended for use in diagnosing these patients where it is difficult to decide if a biopsy is necessary to verify a potential clinically
significant cancer diagnosis. The high unmet need for improved patient stratification or diagnostic triage in this segment is addressed
only by a few tests. Compared to those tests Proclarix has important competitive advantages: (i) it shows comparable or often superior
clinical performance, (ii) it is blood-based and therefore minimally invasive and (iii) it is highly reproducible in comparison to e.g.,
urine-based tests. The use of Proclarix does not require prior prostate massage. Samples are stable and can be shipped at ambient temperature.
Proclarix has a high accuracy and negative predictive value (NPV) and is easy to automate on equipment readily available as well as adaptable
to current laboratory practice and thus clinical routine.

 The worldwide market for in vitro diagnostic ("IVD")
products was valued at $101 billion in 2024. Europe and North America are the largest markets, followed by Asia, mainly Japan and China,
according to MarketsandMarkets.

 About two-thirds of prostate cancer diagnoses
occur in countries ranking very high in the Human Development Index, where only 18% of the world's male population resides, according
to the American Cancer Society. This underscores a significant market demand for improved diagnostic tools, especially in regions with
robust healthcare infrastructure where early detection and treatment are paramount. Our innovative test aims to meet this demand by offering
enhanced accuracy, accessibility, and efficiency, positioning it as a valuable asset in the fight against prostate cancer while also presenting
lucrative commercial opportunities for stakeholders.

 Currently, standard prostate cancer screening
combines a digital rectal exam ("DRE") with the measurement of PSA. PSA is not a highly cancer specific marker, meaning it
picks up many benign conditions of raised PSA levels in the blood—such as clinically not significant enlargement of the prostate
or inflammation. The consequences are prostate cancer overdiagnosis, leading to unnecessary prostate biopsies. It is currently estimated
that more than 60% of men that undergo a biopsy have no clinically significant prostate cancer, but due to the biopsy become exposed to
potential side effects such as infections, bleeding and incontinence.

 The use of MRI for the diagnosis of prostate cancer
has been rapidly adopted during the last decade. There is clinical evidence that MRI allows clinicians to verify diagnosis and improve
localization, risk stratification and staging of clinically significant prostate cancer over other methods. MRI-guided biopsy has a higher
accuracy than ultrasound-guided biopsy. However, MRI-based diagnosis of prostate cancer is hampered by the relatively high costs of US$415
– US$900 and limited availability. Still, up to one-third of MRIs are inconclusive. Thus, there is a clear need for an improved
non-invasive diagnostic test with higher specificity for clinically significant prostate cancer to aid in selecting patients undergoing
MRI, MRI-guided biopsy, and biopsy. Proper classification in clinically significant cancer and non-significant type or non-cancer conditions
such as benign prostate hyperplasia is important to prevent overtreatment and its associated side-effects and costs. Proteomedix is developing
diagnostic tools for disease prognosis and monitoring that are essential for reliable, patient-friendly, and cost-effective disease management.
Proteomedix's biomarkers have shown the potential to distinguish between those prostate cancer patients who are more likely to respond
to certain drug-based interventions. With this information, better choices for drug therapies can be made to maximize the likelihood of
efficacious treatment. Proteomedix's biomarkers could also aid in clinical drug development.

 Competition

 Proclarix Competition Analysis

 The molecular diagnostics field is intensely competitive
and characterized by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition,
evolving industry standards, reimbursement uncertainty and price competition. Moreover, recent consolidation in the industry permits larger
clinical laboratory service providers to increase cost efficiencies and service levels, resulting in more intense competition.

 The market for assessing men at risk for prostate
cancer is large, with many competitors some of which possess substantially greater financial, selling, logistical and laboratory resources,
more experience in dealing with third-party payors, and greater market penetration, purchasing power and marketing budgets, as well as
more experience in providing diagnostic services. Some companies and institutions are developing liquid biopsy (blood and urine)-based
tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids, or the presence of fragments of mutated genes that
are associated with prostate cancer. These competitors could have technological, financial, reputational, and market access advantages
over us.

 There are a number of tests already on the market
or in clinical testing or commercial development that are also intended to triage diagnostics in men with moderately elevated PSA levels.
Of these tests the majority also target solely PSA as a biomarker. Certain isoforms of PSA are differentiated, or transcript levels (mRNA)
are determined in addition to protein levels. Of these tests the best established is %fPSA, which is also available from all suppliers
of the PSA test, including market leaders Abbott Laboratories, Roche Diagnostics, Siemens Healthineers AG and Beckman Coulter, Inc. However,
the sensitivity and specificity improvements are very modest.

 The 4Kscore from OPKO Health, Inc. (Nasdaq: OPK)
and the phi score from Beckman Coulter, Inc. measure additional forms of PSA and related proteins but they do not include additional biomarkers
either. The 4Kscore test is a blood based 4-plex test which combines the results of the blood test with clinical information in an algorithm
that calculates a patient's percent risk for aggressive prostate cancer prior to an initial or repeat biopsy (no previous diagnosis
of prostate cancer). The 4Kscore test received marketing approval from the FDA in December 2021. The phi score combines the results of
three blood tests to provide information about what elevated PSA levels might mean and the probability of finding prostate cancer on biopsy.
The IsoPSA test of Cleveland Diagnostics, Inc. analyzes structural changes of PSA to detect underlying cancer biology.

 Over the last decade, gene-based testing in urine
targeting additional biomarkers became available. The PCA3 test from Gen-Probe Inc. (now a part of Hologic, Inc.) was the first genetic
assay to be introduced to the market. The SelectMDx test from MdxHealth SA measures a combination of two genes and integrates them together
with PSA value, prostate volume, patient age and digital rectal exam to a risk score. The assay targets mRNA transcripts in the patient's
urine. mRNA is normally not sufficiently shed into urine to allow for direct analysis. Therefore, this test method requires prostate massage
prior to sample collection and the urine samples will be collected in a specialized practice. The ExoDx IntelliScore from Exosome Diagnostics,
Inc., a subsidiary of Bio-Techne Corporation, measures PCA3 as well as other gene transcripts in exosomes harvested from urine. The method
does not require prostate massage, however, because mRNA is relatively unstable, the samples require cold storage in shipment and relatively
rapid testing turn-around.

 The Stockholm3 test is part of an academic initiative,
OncoWatch, led by the Karolinska Institute, Sweden and funded by the European Institute of Innovation and Technology Health program. Established
in 2020, A3P Biomedical AB (publ) is commercializing the Stockholm3 test. It is a blood-based test that predicts the risk for aggressive
prostate cancer at biopsy by analyzing five protein markers, more than 100 genetic markers and clinical data.

 Except for PCA3, Prostate Health Index and 4Kscore,
all of the above-mentioned tests are only available as a testing service through specialized reference laboratories, they are not offered
as commercial products. Testing is performed centrally as a laboratory developed test ("LDT") by a single diagnostic laboratory.
Uptake of LDTs in the United States has been limited, and in Europe they are mostly not known to urologists.

 In recent years, MRI-based diagnosis followed
by targeted biopsy is becoming the standard of choice in specialized centers. As MRI instrumentation is costly and its availability is
still limited, there is a need for diagnostics supporting the decision to perform MRI that Proclarix can fulfill. MRI is not regarded
as competitive to the Proclarix positioning, but complementary.

 Competitive Advantages of Proclarix

 We believe Proclarix has important competitive
advantages:

 Blood-based test

 -

 Minimally invasive, high reproducibility, no prostate massage required, suitably stable for shipment, the most common sample type in clinical laboratories and therefore fitting in current lab workflow

 Immunoassay-based

 -

 Compatible with existing laboratory instrumentation in local laboratory

 Easy to automate

 -

 Adaptable to clinical routine, fast time to result

 Objective result generation

 -

 Comparable results independent of operator

 Genetics-guided discovery

 -

 Cancer-related, highly plausible biomarkers

 Proclarix can be applied in any diagnostic laboratory,
using readily available immunoassay technology platforms. Furthermore, Proclarix fits very well into the current laboratory workflow,
which is important for laboratories that are driven by efficiency and cost.

 The stakeholders benefit in various ways from
Proclarix:

 Patients: Gain more certainty whether
a biopsy is really needed through a minimally invasive procedure with a fast time to result. This results in reduced anxiety about prostate
cancer diagnosis and less complications and side effects from biopsies.

 Physicians: Focus on relevant patients
with clinically significant cancer and increased patient satisfaction by significantly reducing unneeded prostate biopsies and its accompanying
complications. No need for additional training or new logistic processes: Standard blood-drawing equipment can be used, and the blood
sample sent to the current laboratory.

 Laboratory: Increase revenue with
no additional investment for new equipment because Proclarix is readily applicable in most laboratories.

 Payer (insurance company): Increase
profits by saving costs for avoided biopsies (accompanied by risk of complications, discomfort) and resulting overtreatment.

 Government Regulation

 The FDA and other regulatory authorities at federal,
state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing,
manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval,
advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and diagnostics.

 Foreign Regulation

 In order to market any product outside of the
United States, we need to comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy and
governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our product candidates.
For example, in the EU, we must obtain authorization of a clinical trial application, or CTA, in each member state in which we intend
to conduct a clinical trial. Whether or not we obtain FDA approval for a drug, we would need to obtain the necessary approvals by the
comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the drug in those countries.
The approval process varies from country to country and can involve additional product testing and additional administrative review periods.
The time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA approval. Regulatory
approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one
country may negatively impact the regulatory process in others.

 Further, some countries outside of the United
States, including the EU member states, Switzerland and the United Kingdom, have also adopted data protection laws and regulations, which
impose significant compliance obligations. In the EU, the collection and use of personal health data is governed by the provisions of
the General Data Protection Regulation, or GDPR. The GDPR became effective on May 25, 2018, repealing its predecessor directive and increasing
responsibility and liability of pharmaceutical companies in relation to the processing of personal data of EU subjects. The GDPR, together
with the national legislation of the EU member states governing the processing of personal data, impose strict obligations and restrictions
on the ability to process personal data, including health data from clinical trials and adverse event reporting. In particular, these
obligations and restrictions concern potentially burdensome documentation requirements, granting certain rights to individuals to control
how we collect, use, disclose, retain and process information about them, the information provided to the individuals, the transfer of
personal data out of the EU, security breach notifications, and security and confidentiality of the personal data. The processing of sensitive
personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest
among foreign regulators. In addition, the GDPR provides for more robust regulatory enforcement and fines of up to 20 million or
4% of the annual global revenue of the noncompliant company, whichever is greater. Data protection authorities from the different EU member
states may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing
personal data in the EU. Guidance on implementation and compliance practices are often updated or otherwise revised.

 European Union

 European Union Coverage Reimbursement and Pricing

 In the European Union, pricing and reimbursement
schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price
has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug
candidate to currently available therapies, or so-called health technology assessments, in order to obtain reimbursement or pricing approval.
For example, the European Union provides options for its member states to restrict the range of drug products for which their national
health insurance systems provide reimbursement and to control the prices of medicinal products for human use. European Union member states
may approve a specific price for a drug product or may instead adopt a system of direct or indirect controls on the profitability of the
company.

 EU Drug regulation

 In order to market any product outside of the
United States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding
quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution
of our product. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable
foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions
such as in China and Japan. Although many of the issues discussed above with respect to the United States apply similarly in the context
of the EU, the approval process varies between countries and jurisdictions and can involve additional product testing and additional administrative
review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required
to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure
or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others. Failure
to comply with applicable foreign regulatory requirements may be subject to, among other things, fines, suspension or withdrawal of regulatory
approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

 Non-clinical studies and clinical trials

 Similarly to the United States, the various phases
of non-clinical and clinical research in the EU are subject to significant regulatory controls.

 Non-clinical studies are performed to demonstrate
the health or environmental safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with
the principles of good laboratory practice (GLP) as set forth in EU Directive 2004/10/EC. In particular, non-clinical studies, both in
vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which
define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These
GLP standards reflect the Organization for Economic Co-operation and Development requirements.

 Clinical trials of medicinal products in the EU
must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (ICH) guidelines on
good clinical practices (GCP) as well as the applicable regulatory requirements and the ethical principles that have their origin in the
Declaration of Helsinki. Additional GCP guidelines from the European Commission, focusing in particular on traceability, apply to clinical
trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU, it must appoint
an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU
member states, the sponsor is liable to provide 'no fault' compensation to any study subject injured in the clinical trial.

 Certain countries outside of the United States,
including the EU, have a similar process that requires the submission of a clinical study application (CTA) much like the IND prior to
the commencement of human clinical studies. A CTA must be submitted to each country's national health authority and an independent
ethics committee, much like the FDA and the Institutional Review Board ("IRB"), respectively. Once the CTA is approved by
the national health authority and the ethics committee has granted a positive opinion in relation to the conduct of the trial in the relevant
member state(s), in accordance with a country's requirements, clinical study development may proceed.

 The CTA must include, among other things, a copy
of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the
medicinal product under investigation. Currently, CTAs must be submitted to the competent authority in each EU member state in which the
trial will be conducted. Under the new Regulation on Clinical Trials, which is currently expected to become applicable by early 2022,
there will be a centralized application procedure where one national authority takes the lead in reviewing the application and the other
national authorities have only a limited involvement. Any substantial changes to the trial protocol or other information submitted with
the CTA must be notified to or approved by the relevant competent authorities and ethics committees. Medicines used in clinical trials
must be manufactured in accordance with good manufacturing practice (GMP). Other national and EU-wide regulatory requirements also apply.

 Marketing Authorizations

 To market a medicinal product in the EU and in
many other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EU, medicinal product candidates
can only be commercialized after obtaining a Marketing Authorization (MA). To obtain regulatory approval of an investigational medicinal
product under EU regulatory systems, we must submit a marketing authorization application ("MAA"). The process for doing this
depends, among other things, on the nature of the medicinal product. There are two types of Mas:

 the "Union MA", which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ("EMA") and which is valid throughout the entire territory of the EU. The Centralized Procedure is mandatory for certain types of products, such as (i) medicinal products derived from biotechnology medicinal products, (ii) designated orphan medicinal products, (iii) advanced therapy products (such as gene therapy, somatic cell therapy or tissue-engineered medicines), and (iv) medicinal products containing a new active substance indicated for the treatment certain diseases, such as HIV/AIDS, cancer, neurodegenerative diseases, diabetes, other auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or technical innovation or that the granting of authorization would be in the interest of public health in the EU; and

 "National Mas", which are issued by the competent authorities of the EU member states and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in an EU member state, this National MA can be recognized in another member state through the Mutual Recognition Procedure. If the product has not received a National MA in any member state at the time of application, it can be approved simultaneously in various member states through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which is selected by the applicant as the Reference member state.

 Under the above-described procedures, in order
to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk-benefit balance of the product
on the basis of scientific criteria concerning its quality, safety and efficacy.

 Under the Centralized Procedure, the maximum timeframe
for the evaluation of a MAA by the EMA is 210 days. Where there is a major public health interest and an unmet medical need for a product,
the CHMP may perform an accelerated review of a MA in no more than 150 days (not including clock stops). Innovative products that target
an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and
review programs, such as the PRIME scheme, which provides incentives similar to the breakthrough therapy designation in the US PRIME is
a voluntary scheme aimed at enhancing the EMA's support for the development of medicines that target unmet medical needs. It is
based on increased interaction and early dialogue with companies developing promising medicines, to optimize their product development
plans and speed up their evaluation to help them reach patients earlier. Product developers that benefit from PRIME designation can expect
to be eligible for accelerated assessment, but this is not guaranteed. The benefits of a PRIME designation include the appointment of
a CHMP rapporteur before submission of a MAA, early dialogue and scientific advice at key development milestones, and the potential to
qualify products for accelerated review earlier in the application process.

 Mas have an initial duration of five years. After
these five years, the authorization may be renewed for an unlimited period on the basis of a reevaluation of the risk-benefit balance,
unless the EMA decides, on justified grounds relating to pharmacovigilance, to mandate one additional five-year renewal period.

 Data and marketing exclusivity

 The EU also provides opportunities for market
exclusivity. Upon receiving MA, new chemical entity, or reference product candidates, generally receive eight years of data exclusivity
and an additional two years of market exclusivity. If granted, the data exclusivity period prevents generic or biosimilar applicants from
relying on the pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar
MA in the EU during a period of eight years from the date on which the reference product was first authorized in the EU. The market exclusivity
period prevents a successful generic or biosimilar applicant from commercializing its product in the EU until 10 years have elapsed from
the initial authorization of the reference product in the EU. The overall 10-year market exclusivity period can be extended to a maximum
of eleven years if, during the first eight years of those 10 years, the MA holder obtains an authorization for one or more new therapeutic
indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in
comparison with existing therapies. However, there is no guarantee that a product will be considered by the EU's regulatory authorities
to be a new chemical entity, and products may not qualify for data exclusivity.

 Pediatric Development

 In the EU, MAAs for new medicinal products candidates
have to include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan (PIP) agreed
with the EMA's Pediatric Committee (PDCO). The PIP sets out the timing and measures proposed to generate data to support a pediatric
indication of the drug for which MA is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures
of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to
provide pediatric clinical trial data can be waived by the PDCO when these data is not needed or appropriate because the product is likely
to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations,
or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the MA
is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible
for six months' supplementary protection certificate extension (if any is in effect at the time of authorization).

 Post-Approval Requirements

 Similar to the United States, both MA holders
and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the
competent regulatory authorities of the member states. The holder of a MA must establish and maintain a pharmacovigilance system and appoint
an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited
reporting of suspected serious adverse reactions and submission of periodic safety update reports (PSURs).

 All new MAA must include a risk management plan
(RMP) describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks
associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA. Such risk-minimization
measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct
of additional clinical trials or post-authorization safety studies.

 The advertising and promotion of medicinal products
is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising
and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary
of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines
is also prohibited in the EU. Although general requirements for advertising and promotion of medicinal products are established under
EU directives, the details are governed by regulations in each member state and can differ from one country to another.

 The aforementioned EU rules are generally applicable
in the European Economic Area ("EEA") which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.

 For other countries outside of the EU, such as
countries in Latin America or Asia (e.g., China and Japan), the requirements governing the conduct of clinical studies, product licensing,
pricing and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with GCP
and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If we fail
to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of
regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

 Privacy and data protection laws

 We are also subject to laws and regulations in
non-US countries covering data privacy and the protection of health-related and other personal information. For instance, EU member states
and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. Laws and regulations
in these jurisdictions apply broadly to the collection, use, storage, disclosure, processing, and security of personal information that
identifies or may be used to identify an individual, such as names, contact information and sensitive personal data such as health data.
These laws and regulations are subject to frequent revisions and differing interpretations,

 As of May 2018, the General Data Protection Regulation
(GDPR) replaced the Data Protection Directive with respect to the processing of personal data in the European Union. The GDPR imposes
many requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent from
individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime, shortened
timelines for data breach notifications, limitations on retention and secondary use of information, increased requirements pertaining
to health data and pseudonymized (i.e., key-coded) data and additional obligations when we contract third-party processors in connection
with the processing of the personal data. The GDPR allows EU member states to make additional laws and regulations further limiting the
processing of genetic, biometric or health data. Failure to comply with the requirements of GDPR and the applicable national data protection
laws of the EU member states may result in fines of up to 20,000,000 or up to 4% of the total worldwide annual turnover of the preceding
financial year, whichever is higher, and other administrative penalties.

 EU Medical device legislation

 Medical device legislation is harmonized in the
European Union (EU) through the European Commission's New Legislative Framework. The new regulatory framework for medical devices,
published in April 2017, is based on the Medical Devices Regulation (MDR) (EU) 2017/745 applicable for medical devices and active implantable
medical devices and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 applicable for in vitro diagnostic medical
devices (IVDs). The dates of application of the MDR were May 26, 2021 (Article 123(2) as amended by Regulation (EU) 2020/561 and Regulation
2023/607) and May 26, 2022 (Article 113(2)), respectively. As regulations, the legislation applies to all the EU Member States as drafted
and is applicable in the European Economic Area (EEA) which consists of the 27 EU Member States plus Norway, Liechtenstein, and Iceland.

 The new regulatory framework in EU was triggered
by the breast implant scandal (2012) and various similar case scenarios, where the cause identified significant gaps in the market surveillance
and supply chain oversight as well as insufficient controls and compliance to state-of-the-art standards and documentation. Europe's
new regulatory framework for IVDs introduced significant changes for IVD manufacturers; the most important is the up-classification of
IVDs (introduction of 7 classification rules and four risk classes A to D harmonized with the international classification system), which
require independent conformity assessments for most IVD Classes by independent regulatory compliance assessors (Notified Bodies, NB).
Other changes under the IVDR are the increased NB-involvement, a new risk-based classification system and classification rules, increased
elements and compliance to General Safety and Performance Requirements (GSPR), stricter demands on clinical evidence (scientific validity,
analytical and clinical performance), stronger focus for post-market surveillance (PMS) and post-market performance follow-up (PMPF),
stricter regulatory responsibilities throughout the supply chain for economic operators (like importers or distributors) and traceability
through Unique Device Information (UDI, labelling). Overall, the IVDR is a significant expansion of the previous EU-Directive 98/79/EC
(IVDD), which has been effective for IVDs since 1998.

 Since 2022, due to different reasons, the European
Commission issued various updates to the IVDR to introduce transitional provisions for certain IVDs, which are already on the EU market
prior to the Date of Application (legacy devices) and which are not to be substantially changed by function and design (Regulation (EU)
2022/112 and Regulation (EU) 2023/6074). The current accepted transitional periods provided for in IVDR Article 120 will end on either
December 31, 2027, or December 31, 2028. Currently a new proposal (2024/0021 (COD)) is even proposing extended transitional periods up
to December 31, 2029, for some devices (Class B and Class A sterile) and December 31, 2028, for medium risk IVDs (Class C). Due to these
extended transition timelines for legacy devices, many IVD manufacturers are not yet setting compliance to IVDR on their highest priority.

 For the Proclarix IVDs (Assays and Risk Calculator
software), which are class C devices under IVDR, Proteomedix has already CE marked them in 2019 under IVDD and since then started to comply
with IVDR. This includes the performance and safety of the device, specifically clinical performance testing and addressing the clinical
evidence for Proclarix.

 Irrespective of the amendments for extended transition
timelines to IVDR published since 2022 by the European Commission – Proteomedix AG has selected and streamlined the interaction
with a NB (T V S D) for a conformity assessment under IVDR and passed this NB conformity assessment for their Technical Documentation
and Quality Management System according to international standard ISO 13485:2016 ("Design and development, production and distribution
of in-vitro diagnostic reagents and stand-alone software for prostate cancer management") in July 2022.

 Proteomedix AG has agreements signed with Emergo
Europe B.V. acting as their EU Authorized Representative (EU AR, also referred as EC REP).

 The IVDR-compliance of Proclarix devices makes
them as one the first IVDs under the new EU regime and this will have several advantages to other devices marketed under IVDD or without
CE mark yet. Because of the mentioned significant changes introduced with the IVDR, other competitors might face problems and delays when
trying to get to this stage of IVDR compliance. As mentioned before, every new device or substantially changed device would not be able
to use the amended timelines and must fully comply with IVDR before placing them on the EU market. Second, clients (users, laboratories)
might expect compliance with the IVDR at some degree as the new normal (of state-of-the-art quality). Third, for the Proclarix devices
marketed since 2019 in EU, there is automatically systematic post market surveillance data collected from the field, which further can
support the clinical evidence (validity) of the Proclarix devices.

 Proteomedix AG also has an appointed Data Protection
Officer (DPO) for data safety in line to requirements from General Data Protection Regulation (EU) 2016/679 (GDPR) and Swiss Data Protection
Act although there are no personnel data included or affected in the Proclarix IVDs.

 Switzerland and United Kingdom (UK) Medical
Device Regulation

 Switzerland and United Kingdom (UK) are not part
of the EU market and in principle, become third countries with different jurisdictions and differing product regulations. However, these
two countries still align to a certain degree on the European CE Mark and CE marked devices currently can be marketed without significant
additional approval in Switzerland and UK.

 For Switzerland, the new EU Regulations (MDR/IVDR)
required an update of the Mutual Recognition Agreements to include the EU Regulations, which has so far not been negotiated by the Switzerland–EU
Joint Committee for Switzerland and the EU at international treaty level. Therefore, trading of devices can no longer move freely between
the Swiss market and the EU market and the sharing of information between authorities (incl. EUDAMED) or the mutual recognition of certificates
of conformity are not possible and must be regulated through Swiss law separately in Switzerland. The new Swiss law for medical devices,
the Medical Devices Ordinance (MedDO) was introduced in 2020 together with certain obligations for Swiss manufacturers such as registration
with Swissmedic. As a consequence, Swiss manufacturers must appoint an EU-based AR and/or importer in line with Article 11 and Article
13 of the IVDR.

 For UK, IVD manufacturers must comply with the
UK MDR 2002 (Medical device Regulation), which has been revised several times with new guidelines addressed in the Guidance on the Regulation
of In Vitro Diagnostic Medical Devices in Great Britain. Similar to EU, IVD manufacturers must identify the appropriate conformity assessment
procedure for their device and demonstrate compliance with relevant requirements of the applicable legislation for IVDs in the UK for
the purpose of affixing the UKCA mark to their device (UK MDR 2002 Part IV). UKCA marking (UK Conformity Assessed marking) is the UK product
marking requirement that will be needed for devices being placed on the market in UK, substituting the EU requirements for CE Marking
(CE marking will continue to be accepted in Northern Ireland). Most of these IVDs will then require a designated UK Authorized Body (UKAB)-issued
certificate (similar to an EU CE Marking Certificate). EN ISO 13485:2016 is the designated standard under the UK MDR 2002 that covers
QMS requirements for medical device manufacturers. In the UK, device manufacturers must further appoint a single "UK Responsible
Person" for all of their devices, who will act on the manufacturer's behalf to perform tasks, including product registration.
However, for medical devices with a valid CE marking placed on the UK-market, there was a transition time until 1 July 2023 (no requirement
to re-label the device with a UKCA mark), and the UK government recently has extended acceptance of CE marked devices in UK beyond 30
June 2023 (MDR 2002, SI 2002 No 618, as amended).

 Therefore, Proteomedix AG with a valid CE mark
for EU (IVDR) and appointed EU-AR, and local registration in Switzerland (Swissmedic) is in full compliance to the current changed requirements
on the EU, Swiss and UK markets. Proteomedix AG has agreements signed with Emergo Consulting (UK) Ltd. acting as their UK Responsible
Person. The requirement to comply with UKCA marking would apply after 30 June 2030.

 EU – Impact and market opportunities
on other non-EU markets

 With the overall intend from regulators to harmonize
regulation, the CE marking and compliance to European IVDR for the Proclarix can be considered as a state-of-the-art regulatory compliance
with high potential to enter other markets. Some of these like Australia, New Zealand or Singapore and other markets recognize the CE
mark and – though they might have separate approval procedures – are expected to mainly rely on the CE Certificate. For example,
Australia and New Zealand have a Trans-Tasman Mutual Recognition Arrangement (TTMRA), which means that CE mark can be recognized and sold
without additional regulatory processes. Brazil's medical device market regulator, ANVISA, recently announced updates to the IVD
legislation as Resolution (RDC) 830/2023 similar to the EU definition and classification of IVD under IVDR. For US, the FDA recently in
January 2024 amended their title of their Quality System regulation part 820 (QSR), and integrated elements and concepts from ISO 13485:2016
into their new Quality Management System Regulation (QMSR).

 These examples demonstrate that Proclarix with
established CE mark (IVDR) and ISO 13485:2016 QMS has high potential to get faster market access in other non-EU countries, too. It can
be expected that more non-EU country legislations will further adapt their approval or acceptance process to the level of IVDR or ISO
13485 in the forthcoming years.

 Intellectual Property

 Proteomedix's biomarkers were discovered
using a genetics-guided discovery approach focusing on the PI3K/PTEN cancer pathway that plays a dominant role in prostate cancer development.
Applying proteomics technology to a disease-relevant mouse model allowed the identification of proteins specifically linked to the molecular
cause of prostate cancer. The biomarkers and the bioinformatics algorithm used in Proclarix are protected by issued and pending patents
in Europe, the United States, and other countries.

 Cancer arises from different genetic mutations
that can be linked to specific signaling pathways often referred to as cancer pathways. Depending on what pathway is affected in a patient,
results in different cancer subtypes that are more or less aggressive and further determines if a patient responds to a certain drug treatment
or not.

 Proteomedix's biomarkers were discovered
by a group of researchers at ETH Zurich using a genetics-guided discovery approach focusing on the PI3K/PTEN cancer pathway that plays
a dominant role in prostate cancer development. Using a mouse model and mass-spectrometry based proteomics technology including a glycoprotein
enrichment technology led to the identification of proteins directly linked to the molecular cause of cancer and therefore correlating
to the disease status in the prostate. Different serum glycoproteins were combined to form multiplexed biomarker signatures predictive
for tissue PI3K/PTEN status as well as diagnosis and prognosis of prostate cancer (Figure 5). The genetic-guided proteomics approach enabled
the fast discovery and validation of several biomarkers which in different combinations correspond to diagnosis, prognosis and potentially
to therapy response.

 Figure 5: Proteomics approach to improve prostate cancer disease
management.

 The biomarker assays were transferred from a mass
spectrometry-based to an immunoassay-based platform. Immunoassay-based measurement offers several advantages compared to other analytical
methods. In general, immunoassays provide a rapid, sensitive, reproducible, cost effective and easily manageable analysis. The reagents
used are stable and the method is established in routine diagnostic laboratories guaranteeing broad compatibility of Proteomedix's
tests on established automated clinical platforms and thus rapid adoption rates and platform flexibility of the diagnostic tests. The
deep knowledge in selecting novel biomarkers, assay development and clinical development enabled Proteomedix to enable several R&D
partnerships.

 In 2021, Proteomedix entered into a research and
development partnership with New Horizon Health Limited, Grand Cayman, Cayman Islands. The partnership builds on complimentary platform
and biomarker developments with utility in cancer patient management.

 In 2022, Immunovia AB (Sweden) partnered with
Proteomedix to leverage Proteomedix's research and development capabilities and advances their research and development efforts.
With this partnership, Immunovia gained a more flexible research and development organization, increased its research and development
productivity, and refocused internal resources on commercial build up, thus further accelerating the roll-out of their proprietary IMMray TM
Pan Can-d test. The partnership capitalizes on the combined expertise of two leading innovators in proteomics-based diagnostics, who have
both launched innovative oncology tests, Immunovia with IMMray TM Pan Can-d in the U.S. and Proteomedix with Proclarix in
Europe.

 Patents

 Proteomedix has exclusively licensed worldwide
rights to one patent family from ETH Zurich and the State Hospital of St. Gallen, which describes and protects the use of the proprietary
biomarkers for diagnosing and monitoring prostate cancer. The parent international patent application WO 2009138392 A1 was filed on May
12, 2009, claims a priority date of May 14, 2008 (priority date) and was granted in China (CN201027373B), Europe (EP2281201B1), Japan
(JP6025607B) and the United States (US10151755B2/ US9377463B2).

 Proteomedix has also obtained a non-exclusive
license from ETH Zurich for certain patents pertaining to specific enrichment of glycoproteins, including EP1514107 (expired June 3, 2023)
and US7183118 (to expire May 3, 2024), that ETH Zurich licensed from the Institute for Systems Biology (ISB), Seattle. The license enables
Proteomedix to use the glycoprotein technology for the development of new diagnostic products.

 In addition, a new patent covering the latest
development and clinical results was filed by Proteomedix on July 11, 2017, claiming a priority of July 15, 2016. The patent covers the
specific test format and algorithm contained in Proteomedix's first product (Proclarix) for the improved diagnosis of prostate cancer.
An international application (WO2018011212A1) was filed, and the patent was granted in Europe (EP3270163B1), Japan (JP6979712B2), South
Korea (KR102408276B1), Australia (AU2017294979B2), United States (US11320435B2, with term extension of 377 days) and China (CN109477836B)
with the application still pending in Canada (CA3028874A1).

 A patent application describing and claiming a
method combining Proclarix and magnetic resonance imaging to diagnose prostate cancer was filed by Proteomedix on June 29, 2021. The patent
was originally filed in Switzerland and subsequently as PCT application (WO2023274742A1) and as national applications in the United States
and China.

 A patent application describing and claiming a
method measuring a blood-based protein combination with prognostic utility in prostate cancer patients was filed by Proteomedix on June
29, 2021. The patent was originally filed in Switzerland followed by an international application (WO2018011212A1). National applications
were filed in Europe, United States and China.

 Trademarks

 The brand "Proteomedix" was filed
on June 4, 2010, and registered under no. 602190 in Switzerland on June 22, 2010. This application served as the basis for the international
trademark application. The product name "Proclarix" was filed on July 1, 2019, and registered under no. 733974 in Switzerland
on July 22, 2019. This application served as the basis for the international trademark application. The product name "Prosgard"
was filed on July 1, 2019, and registered under no. 733975 in Switzerland on July 22, 2019.

 Manufacturing and Supply

 We currently do not own or operate any manufacturing
facilities. For Proclarix, we outsource manufacturing to a CMO in Germany. All of the key reagents used in Proteomedix's IVD kits
(i.e., antigens and antibodies) are proprietary and owned exclusively by Proteomedix. These reagents are produced by an independent supplier
in Germany and shipped to the CMO for manufacturing of the IVD kits. The development and production of the Proclarix risk calculator software
and the hosting of the Proclarix risk calculator software are performed by external suppliers.

 Employees

 As of May 30, 2025, we had 5 full-time and 2 subcontracted
employees. None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage.
We believe we have good relations with our employees.

 Properties and Facilities

 We currently lease an office located at 201 E
Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.

 Additionally, Proteomedix leases office and lab
space located at Wagistrasse 23, 8952 Schlieren, Switzerland. This lease expires on June 30, 2025, subject to renewal for successive two-year
terms. The lease will automatically renew unless terminated. Either party may terminate the lease with 12 months' written notice.

 Corporate Information

 We were incorporated on October 22, 2018 under
the laws of the State of Delaware. Our principal executive offices are located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202,
and our telephone number is (513) 620-4101. Our corporate website address is www.onconetix.com. We make available free of charge
on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy
statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act
as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the SEC. Alternatively, you may
also access our reports at the SEC's website at www.sec.gov.

 Buyback Program

 On November 10, 2022, the Board approved a stock
repurchase program (the "Repurchase Program") to allow the Company to repurchase up to 125,000 shares of common stock with
a maximum price of $1.00 per share, with discretion to management to make purchases subject to market conditions. On November 18, 2022,
the Board approved an increase to the maximum price to $2.00 per share. There was no expiration date for this program and the maximum
price per share was not adjusted in connection with the reverse split. Shares that are repurchased are classified as treasury stock pending
future use and reduce the number of shares outstanding used in calculating earnings per share.

 On November 13, 2024, the Board terminated the
Repurchase Program. During the fiscal year ended December 31, 2024, there were no repurchases. During the fiscal year ended December 31,
2023, the Company repurchased 1,441 shares of common stock under the Repurchase Program, for an aggregate of approximately $59,000, at
an average price of $40.8 per share.

 Fundraising Activities

 On July 11, 2024, the Company entered into the
Inducement Letters with certain holders of existing preferred investment options to purchase shares of the Company's common stock
at the original exercise prices of $101.84 and $43.60 per share, issued on August 11, 2022 and August 2, 2023, respectively, pursuant
to which the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 186,466 shares of the Company's
common stock, at a reduced exercise price of $6.00 per share, in consideration for the Company's agreement to issue new preferred
investment options (the "Inducement PIOs") to purchase up to an aggregate of 559,397 shares of the Company's common
stock. Of the 559,397 PIOs issued, 186,465 have a contractual term of 5 years, while the remaining 372,932 have a contractual term of
2 years. Aside from the contractual terms, the Inducement PIOs have substantially the same terms as the Existing PIOs.

 On July 11, 2024, the Company consummated the
transaction contemplated by the Inducement Letters upon unanimous written consent of the Board (the "Warrant Inducement").
The Company received aggregate net proceeds of approximately $0.9 million from the exercise of the Existing PIOs by the holders and the
sale of the Inducement PIOs, after deducting placement agent fees and other offering expenses payable by the Company.

 On October 1, 2024, the Board authorized the Company
to create a series of 10,000 shares of preferred stock designated as "Series C convertible Preferred Stock", with a par value
of $0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible Preferred
Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. On October
2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the "PIPE Investors"), pursuant
to the securities purchase agreement an aggregate of 3,499 shares of Series C convertible preferred stock, par value $0.00001 per share,
which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the PIPE Investors'
irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 591,856 shares of Common Stock, (together,
the "PIPE Securities") for aggregate net cash proceeds to the Company of $1.9 million.

 On October 2, 2024, the Company entered into a
Common Stock ELOC Purchase Agreement relating to a Committed Equity Facility with an institutional investor (the "ELOC Purchaser"),
whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase,
up to $25.0 million of the Company's newly issued Common Stock, subject to certain limitations. As of December 31, 2024 and May
30, 2025, the Company has sold approximately 2,757,933 shares and 33,256,563 shares under the ELOC Purchase Agreement for aggregate proceeds
of approximately $0.9 million and $5.3 million, respectively, totaling 36,014,496 shares sold under the ELOC Purchase Agreement for gross
proceeds of approximately $6.2 million. In January 2025, there were 3,492,067 shares that were settled bringing the total sold shares
to approximately 6,250,000 shares under the ELOC Purchase Agreement. Additionally, as of May 30, 2025, an aggregate of 2,130 Series C
Preferred Stock was outstanding, after redemptions of 1,369 shares for an aggregate of $1.71 million. An additional amount of $150,531
is due to the PIPE Series C investors for 120 Series C preferred shares that remain due from the most recent ELOC draw. These 120 shares
remain subject to future redemption.

 Legal Proceedings

 From time to time we may be involved in various
disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings.

 Item 1A. Risk Factors.

 Investing in our common
stock involves a high degree of risk. You should carefully consider the following information about these risks, together with the other
information appearing elsewhere in this Report, including our financial statements, the notes thereto and the section entitled "Management's
Discussion and Analysis of Financial Condition and Results of Operations," before deciding to invest in our common stock. The occurrence
of any of the following risks could have a material adverse effect on our business, reputation, financial condition, results of operations
and future growth prospects, as well as our ability to accomplish our strategic objectives. As a result, the trading price of our common
stock could decline, and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or
that we currently deem immaterial may also impair our business operations and the market price of our common stock.

 Risks Related to our Financial Position and
Need for Capital

 We have incurred significant net losses
since inception, have only generated minimal revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable
future and may never achieve profitability. Our stock is a highly speculative investment.

 We are a commercial-stage biotechnology company
that was incorporated in October 2018. Our net loss was $58.7 million and $37.4 million for the years ended December 31, 2024 and 2023,
respectively. As of December 31, 2024, we had an accumulated deficit of $115.7 million. We also generated negative operating cash flows
of $10.5 million for the year ended December 31, 2024.

 We expect to continue to spend significant resources
to commercialize our product. We expect to incur substantial and increasing operating losses over the next several years. As a result,
our accumulated deficit will also increase significantly. Additionally, there can be no assurance that our current product or those that
may be under development by us in the future will be commercially viable. If we are unable to achieve profitability or raise sufficient
working capital, we may be unable to continue our operations.

 There is substantial doubt about our ability
to continue as a "going concern," and we will require substantial additional funding to finance our long-term operations.
If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate our product or other operations.

 The Company
has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable
future. As of December 31, 2024, the Company had cash of approximately $0.6 million, a working capital deficit of approximately
$17.3 million and an accumulated deficit of approximately $115.7 million.

 We estimate, as of the date of this Report, that
our current cash balance is not sufficient to fund operations through the end of May 2026. We believe that we will need to raise substantial
additional capital to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support the
Company's working capital needs and business activities, including the commercialization of Proclarix, which is still subject to
further successful development and commercialization activities within certain jurisdictions.

 Management also intends to secure additional required
funding through equity or debt financings if available. In December 2024, the Company began utilizing the ELOC entered into in October
2024 (see Note 9) on an as-needed basis to fund current operating needs, subject to certain restrictions and beneficial ownership constraints.
However, based on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under
the ELOC will not be sufficient to sustain operations. In addition, there are currently no other commitments in place for further financing
nor is there any assurance that such financing will be available to the Company on favorable terms, if at all. This creates significant
uncertainty whether the Company will have the funds available to be able to sustain its operations and expand commercialization of Proclarix.
If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization
of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient
to sustain operations and meet its obligations, or, if its required to, file for bankruptcy.

 These conditions raise substantial doubt about
the Company's ability to continue as a going concern for a period of time within one year following the date of this Report. Our
future capital requirements will depend on many factors, including:

 the costs of future development and commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for Proclarix, and other products for which we have received or will receive marketing approval;

 our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement;

 any product liability or other lawsuits related to our product;

 the expenses needed to attract, hire, and retain skilled personnel;

 the revenue, if any, received from commercial sales of Proclarix or other products for which we may receive marketing approval;

 the costs to establish, maintain, expand, enforce, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending, and enforcing our patents or other intellectual property rights; and

 the costs of operating as a public company.

 Our ability to raise additional funds will depend
on financial, economic, and other factors, many of which are beyond our control. We cannot be certain that additional funding will be
available on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital
in sufficient amounts or on terms acceptable to us, we may be forced to delay, reduce or terminate our business activities.

 We owe a significant amount of money to
Veru, which funds we do not have. Veru may take action against us to enforce its rights to payment in the future, which could have a material
adverse effect on us and our operations.

 Due to recent financial constraints, the Company
may be unable to timely pay amounts due to Veru, from whom we purchased ENTADFI in April 2023. We may not have sufficient funds to pay
amounts due to Veru in the near term, if at all, including but not limited to $10 million, $5 million of which was due on April 19, 2024
and is subject to certain forbearance terms, and $5 million of which was due on September 30, 2024 and was subject to certain forbearance
terms. On April 24, 2024, Veru agreed to forbear its rights and remedies until March 31, 2025, which forbearance period was further extended
until June 30, 2025 by limited waiver on March 31, 2025 and April 24, 2025, with respect to, among other things, our inability to pay
amounts due on April 19, 2024, and on September 19, 2024, Veru agreed to forbear its rights and remedies until June 30, 2025 with respect
to, among other things, our inability to pay amounts due on September 30, 2024. In addition, on November 26, 2024, the Company and Veru
entered into a waiver and amendment to the forbearance agreement, pursuant to which Veru agreed to waive the due date for payment of applicable
Company cash receipt payments generated in October 2024 in consideration for an increase in payments to be made to Veru out of future
financing and strategic transactions through June 30, 2025. However, Veru may take future action against us, including filing legal proceedings
against us seeking amounts due and interest accrued or attempting to terminate its relationship with us. If Veru were to take legal action
against us, we may be forced to scale back our business plan and/or seek bankruptcy protection. We may be subject to litigation and damages
for our failure to pay amounts due to Veru, and may be forced to pay interest and penalties, which funds we do not currently have.

 In light of (i) the time and resources needed to continue pursuing
commercialization of ENTADFI, and (ii) the Company's cash runway and indebtedness, the Company has abandoned commercialization of
ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There
is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction
of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.

 We plan to seek funding to support our operations
and to pay amounts due to Veru, through a combination of equity offerings, debt financing or other capital sources, including potential
collaborations, licenses, sales, and other similar arrangements, which may not be available on favorable terms, if at all. The sale of
additional equity or debt securities, if accomplished, may result in dilution to our stockholders. Furthermore, any revenue or financing
proceeds that we are required to pay to Veru will detract from our ability to use such funds to support our operations.

 Our current liabilities are significant,
and if those to whom we owe accounts payable, such as Veru or other vendors, were to demand payment, we would be unable to pay.

 As of December 31, 2024, we had total current
liabilities of approximately $18.3 million, including accounts payable of approximately $3.8 million, accrued expenses of approximately
$0.9 million, and approximately $9.3 million (net of discount) related to the notes payable due to Veru. As of the same date, we had cash
of only $0.6 million. In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company's
cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist
with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI,
and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy
our inventory of the product. We plan to seek funding to support our operations. We have also concurrently reduced our liabilities by
entering into a settlement agreement, dated January 15, 2025, with IQVIA, Inc. concerning potential termination payments, whereby we recorded
an adjustment of approximately ($0.9) million in accounts payable. However, the level of our current liabilities may make it more difficult
for us to obtain adequate financing on favorable terms, if at all. If those to whom these payments are due were to demand immediate payment,
as they are entitled to do, and we are not able to make the required payments, we would be subject to liability if our creditors chose
to enforce their rights, which could result in our bankruptcy and insolvency. Under such a scenario, our assets would be distributed to
our creditors leaving nothing to be distributed to our stockholders.

 Risks Related to the Commercialization of our Product

 The marketing approval
processes in the United States are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing
approval for Proclarix, our business may be harmed.

 Although the FDA regulates
in vitro diagnostic devices, some laboratory companies like LabCorp have successfully commercialized diagnostic tests for various conditions
and disease states without seeking clearance or approval for such tests through a 510(k) or Premarket Application ("PMA")
approval process. These tests are known as LDTs and are designed, manufactured, and used within a single laboratory that is certified
under the Clinical Laboratory Improvement Amendments ("CLIA"). CLIA is a federal law that regulates clinical laboratories
that perform testing on specimens derived from humans for the purpose of providing information for diagnostic, preventative or treatment
purposes. Such LDT testing is currently under the purview of the Centers for Medicare & Medicaid Services ("CMS") and
state agencies that provide oversight of the safe and effective use of LDTs. A large number of laboratory testing in the United States
consists of LDTs.

 Proclarix has not yet
advanced to the point when LabCorp could seek marketing approval for commercialization by CMS and state agencies in the United States.
LabCorp cannot commercialize Proclarix in the United States without first obtaining approval from the CMS and state agencies, and Proclarix
marketing approval could be delayed.

 On May 6, 2024,
the FDA issued a final rule to amend its regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic
Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration
is phasing out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory will generally fall under
the same enforcement approach as other IVDs. If the new requirements are phased in, future offerings may require a 510(k) submission or
a PMA application to the FDA.

 This regulatory review
and approval process for medical devices can be costly, timely, and uncertain. This process may involve, among other things, successfully
completing additional clinical trials and submitting a premarket clearance notice or filing a premarket approval application with the
FDA. If premarket review is required by the FDA, there can be no assurance that Proclarix will be cleared or approved on a timely basis,
if at all. In addition, there can be no assurance that the labeling claims cleared or approved by the FDA will be consistent with our
current claims or adequate to support continued adoption of and reimbursement for our products. Ongoing compliance with FDA regulations
could increase the cost of conducting business, subject us to FDA inspections and other regulatory actions, and potentially subject us
to penalties in the event we fail to comply with such requirements.

 We depend entirely on the success of a single
product. If we do not successfully commercialize our product or we experience significant delays in doing so, this product may not be
profitable.

 Our business currently depends heavily on the
successful commercialization of our product. We cannot be certain that our product will be successfully commercialized. The manufacturing,
safety, efficacy, labeling, sale, marketing, and distribution of our product are, and will remain, subject to comprehensive regulation
by the FDA and similar foreign regulatory authorities. The success of our product will depend on several additional factors, including:

 establishing commercial manufacturing capabilities;

 launching commercial sales, marketing and distribution operations;

 establishing relationships with partners having established distribution, marketing and sales capabilities;

 the prevalence and severity of adverse events experienced with our product;

 acceptance of our product by patients, the medical community, and third-party payors;

 a continued acceptable safety profile following approval;

 obtaining and maintaining healthcare coverage and adequate reimbursement for our product;

 competing effectively with other therapies and diagnostics, including with respect to the sales and marketing of our product; and

 qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.

 Many of these factors are beyond our control,
including potential threats to our intellectual property rights and changes in the competitive landscape. If we do not achieve one or
more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize
our product, which would materially harm our business, financial condition, and results of operations.

 Obtaining and maintaining regulatory approval
of our product in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions.

 Obtaining and maintaining regulatory approval
of our product in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction,
while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process
in others. For example, even if the FDA grants marketing approval of a pharmaceutical product, comparable regulatory authorities in foreign
jurisdictions must also approve the manufacturing, marketing and promotion of the product in those countries. Approval procedures vary
among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United
States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted
by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product must be approved for reimbursement
before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our product is also subject
to approval.

 We may also submit marketing applications in other
countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of pharmaceutical or diagnostic
products with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with
foreign regulatory requirements could result in significant delays, difficulties, and costs for us and could delay or prevent the introduction
of our product in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable
marketing approvals, our target market will be reduced and our ability to realize the full market potential of our vaccine candidates
will be harmed.

 Even if we are able to commercialize our
product, it may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives,
which would harm our business.

 The regulations that govern marketing approvals,
pricing, coverage, and reimbursement for new drugs and diagnostics vary widely from country to country. In the United States, new and
future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in
obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing
review period begins after marketing or product-licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing
remains subject to continuing governmental control even after initial marketing approval is granted.

 Our ability to commercialize our product successfully
also will depend in part on the extent to which coverage and adequate reimbursement for this product and related treatments will be available
from government health programs, private health insurers, integrated delivery networks and other third-party payors. Third-party payors
decide which drugs they will pay for and establish reimbursement levels. A significant trend in the U.S. healthcare industry and elsewhere
is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount
of payment for particular drugs. Increasingly, third-party payors are requiring that drug companies provide predetermined discounts from
list prices and are challenging the prices charged for medical products. Coverage and reimbursement may not be available for any product
that we commercialize and, if reimbursement is available, the level of reimbursement may not be sufficient for commercial success. Coverage
and reimbursement may impact the demand for, or the price of, our product. If coverage and reimbursement is not available or is available
only to limited levels, we may not be able to successfully commercialize our product.

 There may be significant delays in obtaining coverage
and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved
by the FDA or similar regulatory authorities outside the United States. Moreover, eligibility for coverage and reimbursement does not
imply that any product will be paid for in all cases or at a rate that covers our costs, including manufacture, sale and distribution.
Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.
Coverage and reimbursement rates may vary according to the use of the drug and the medical circumstances under which it is used may be
based on reimbursement levels already set for lower cost products or procedures or may be incorporated into existing payments for other
services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private
payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices
than in the United States. Commercial third-party payors often rely upon Medicare coverage policies and payment limitations in setting
their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded programs
and private payors for our product could have a material adverse effect on our operating results, our ability to raise capital needed
to commercialize our product and our overall financial condition.

 Our product could be subject to marketing
restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if
we experience unanticipated problems with our product.

 Our product, along with the manufacturing processes
and facilities, post-approval clinical data, labeling, advertising, and promotional activities for such product, will be subject to continual
requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of promotional materials
and safety and other post-marketing information and reports, registration and listing requirements, current Good Manufacturing Practice
("cGMP") requirements for product facilities, quality assurance and corresponding maintenance of records and documents and
requirements regarding the distribution of samples to physicians and related recordkeeping. The FDA closely regulates the post-approval
marketing and promotion of drugs to ensure that they are marketed only for the approved indications and in accordance with the provisions
of the approved labeling. However, companies may share truthful and not misleading information that is otherwise consistent with the product's
FDA approved labeling. The FDA imposes stringent restrictions on manufacturers' communications regarding off-label use and if we
do not comply with these restrictions, we may be subject to enforcement actions.

 In addition, later discovery of previously unknown
problems with our product, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements,
may result in, among other things:

 restrictions on our product, manufacturers or manufacturing processes or facilities;

 restrictions on the labeling, marketing, distribution, or use of a product;

 requirements to conduct post-approval clinical trials, other studies, or other post-approval commitments;

 warning or untitled letters;

 withdrawal or recall of our product from the market;

 refusal to approve pending applications or supplements to approved applications that we submit;

 fines, restitution or disgorgement of profits or revenue;

 suspension or withdrawal of marketing approval;

 refusal to permit the import or export of our product;

 product seizure; and

 injunctions or the imposition of civil or criminal penalties.

 Failure to obtain regulatory approvals in
foreign jurisdictions will prevent us from marketing our product and product candidates internationally.

 We intend to market our product and product candidates
in international markets. In order to market our product in regions such as the EEA, Asia Pacific, and many other foreign jurisdictions,
we must obtain separate regulatory approvals.

 For example, in the EEA, medicinal products can
only be commercialized after obtaining a Marketing Authorization, or MA. Before granting the MA, the European Medicines Agency, or the
competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific
criteria concerning its quality, safety and efficacy. In Japan, the Pharmaceuticals and Medical Devices Agency, or the PMDA, of the Ministry
of Health Labour and Welfare, or MHLW, must approve an application under the Pharmaceutical Affairs Act before a new drug product may
be marketed in Japan.

 We have had limited interactions with foreign
regulatory authorities. The approval procedures vary among countries and can involve additional clinical testing, and the time required
to obtain approval may differ from that required to obtain FDA approval. Moreover, clinical studies conducted in one country may not be
accepted by regulatory authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other
countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign
countries or by the FDA. However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the
regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.
We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and even
if we file, we may not receive necessary approvals to commercialize our product in any market.

 Company shareholders may not realize a benefit from the ENTADFI
or Proteomedix acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions.

 If the Company is unable to realize the full strategic and financial
benefits previously anticipated from the recent ENTADFI and Proteomedix acquisitions, our shareholders may experience a dilution of their
ownership interests in our Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the
extent the Company is able to realize only part of the strategic and financial benefits previously anticipated from the transactions.
In light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company's cash runway
and indebtedness, the Company has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the
potential sale or other transaction of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such,
if we are not able to consummate a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory
of the product.

 Disruptions to or significantly increased
costs associated with transportation and other distribution channels for Proclarix may adversely affect our margins and profitability.

 We expect to rely on the uninterrupted and efficient
operation of third-party logistics companies to transport and deliver Proclarix. These third-party logistics companies may experience
disruptions to the transportation channels used to distribute our product, increased airport and shipping port congestion, a lack of transportation
capacity, increased fuel expenses, and a shortage of manpower or capital or due to other business interruptions. Disruptions to the transportation
channels experienced by our third-party logistics companies may result in increased costs, including the additional use of airfreight
to meet demand. Disruptions to this business model or our relationship with the third party if, for example, performance fails to meet
our expectations, could harm our business.

 We may fail or elect not to commercialize
our product.

 We may not successfully commercialize our product.
We or our collaboration partners in any potential commercial marketing efforts of our product may not be successful in achieving widespread
patient or physician awareness or acceptance of this product. Also, we may be subject to pricing pressures from competitive products or
from governmental or commercial payors or regulatory bodies that could make it difficult or impossible for us to commercialize our product.
Any failure to commercialize our product could have a material adverse effect on our future revenue and our business.

 In light of (i) the time and resources needed
to continue pursuing commercialization of ENTADFI, and (ii) the Company's cash runway and indebtedness, the Company has abandoned
commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction of the ENTADFI
assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other
transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product.

 If we fail to commercialize Proclarix, our business,
financial condition, results of operations and prospects may be materially adversely affected and our reputation in the industry and in
the investment community would likely be damaged.

 We are dependent on third parties, including
LabCorp, to develop, market, distribute and sell our product.

 Our ability to receive revenues is dependent upon
the sales and marketing efforts of co-marketing partners and third-party distributors. In particular, the development and commercialization
of Proclarix in the United States is being pursued by LabCorp, pursuant to an exclusive license agreement that grants LabCorp the exclusive
right to develop and commercialize Proclarix, and other products developed by LabCorp using Proteomedix's intellectual property
covered by the license, in the United States for identification, screening, staging, predisposition, diagnosis, prognosis, monitoring,
prevention or treatment selection with respect to prostate cancer. However, we do not have control over LabCorp's development and
commercialization of Proclarix, and there can be no guarantee that LabCorp will continue to advance development and commercialization
efforts, or that LabCorp will successfully commercialize Proclarix in the United States.

 LabCorp may terminate or seek to renegotiate the
terms of this agreement, which could adversely affect our business operations and financial condition. If LabCorp terminates the agreement
or demands terms that are less favorable to us, we may experience disruptions in our product development and commercialization efforts,
potentially leading to a loss of revenue and market share.

 Additionally, if LabCorp is unable to commercialize
Proclarix in the United States, and we fail to reach an agreement with any other commercialization partner, or upon reaching such an agreement
that partner fails to sell a large volume of our product, it may have a negative impact on our business, financial condition, and results
of operations.

 We may not be able to gain and retain market
acceptance for our product.

 Physicians and other authorized health care practitioners
may not prescribe our product, which would prevent our product from generating revenue. Market acceptance of our product by healthcare
providers, patients and payors, will depend on a number of factors, many of which are beyond our control, including the following:

 the clinical indications for which our product is approved;

 acceptance by healthcare providers and payors of our product as safe and effective treatment or test;

 the cost in relation to alternative treatments or tests;

 the relative convenience and ease of administration of our product for the conditions for which it is intended;

 the availability and efficacy of competitive drugs or tests;

 the effectiveness of our sales and marketing efforts;

 the extent to which our product is approved for inclusion on formularies of hospitals and managed care organizations;

 the availability of coverage and adequate reimbursement by third parties, such as insurance companies and other health care payors, or by government health care programs, including Medicare and Medicaid;

 limitations or warnings contained in a product's FDA or other applicable regulatory agency's approved labeling; and

 prevalence and severity of adverse side effects.

 Even if the medical community accepts that our
product is safe and efficacious for its approved indications, healthcare providers may not immediately be receptive to the use or may
be slow to adopt such product as an accepted treatment or test for the conditions for which it is intended. Without head-to-head comparative
data, we will also not be able to promote our product as being superior to competing products. If our product does not achieve an adequate
level of acceptance by healthcare providers and payors, we may not generate sufficient or any revenue from this product. In addition,
our efforts to educate the medical community and third-party payors on the benefits of our product may require significant resources and
may never be successful.

 In addition, even if our product achieves market
acceptance, we may not be able to maintain that market acceptance over time if:

 new products or technologies are introduced that are more favorably received than our product, are more cost effective or render our product obsolete;

 unforeseen complications arise with respect to use of our product or

 sufficient third-party insurance coverage or reimbursement does not remain available.

 Proclarix is subject to competition from
other prostate cancer diagnostics and larger, well-established companies with substantially greater resources than us.

 The molecular diagnostics field is intensely competitive
and characterized by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition,
evolving industry standards, reimbursement uncertainty and price competition. Moreover, recent consolidation in the industry permits larger
clinical laboratory service providers to increase cost efficiencies and service levels, resulting in more intense competition.

 The market for assessing men at risk for prostate
cancer is large, with many competitors some of which possess substantially greater financial, selling, logistical and laboratory resources,
more experience in dealing with third-party payors, and greater market penetration, purchasing power and marketing budgets, as well as
more experience in providing diagnostic services. Some companies and institutions are developing liquid biopsy (blood and urine)-based
tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids, or the presence of fragments of mutated genes that
are associated with prostate cancer. These competitors could have technological, financial, reputational, and market access advantages
over us.

 The commercial success of our in-development
and future diagnostic tests and services and our revenue growth depend upon attaining significant market acceptance among payers, providers,
clinics, patients, and biopharmaceutical companies.

 Our commercial success depends, in part, on the
acceptance of our diagnostic tests and services as being safe and relatively simple for medical personnel to learn and use, clinically
flexible, operationally versatile and, with respect to providers and payers, cost effective. We cannot predict how quickly, if at all,
payers, providers, clinics, and patients will accept future diagnostic tests and services or, if accepted, how frequently they will be
used. These constituents must believe that our diagnostic tests offer benefits over other available alternatives.

 The degree of market acceptance of our current
and future diagnostic tests and services depends on a number of factors, including:

 whether there is adequate utilization of our tests by clinicians, laboratories and other target groups based on the potential and perceived advantages of our diagnostic tests over those of our competitors;

 the convenience and ease of use of our diagnostic tests relative to those currently on the market;

 the effectiveness of our sales and marketing efforts;

 the ability of our distribution partners to meet sales forecasts;

 our ability to provide incremental data that show the clinical benefits and cost effectiveness, and operational benefits, of our diagnostic tests;

 the coverage and reimbursement acceptance of our product and services;

 pricing pressure, including from group purchasing organizations ("GPOs"), seeking to obtain discounts on our diagnostic tests based on the collective bargaining power of the GPO members;

 negative publicity regarding our or our competitors' diagnostic tests resulting from defects or errors; and

 the diagnostic sensitivity and diagnostic specificity of our tests relative to those of our competitors.

 Additionally, even if our diagnostic tests achieve
widespread market acceptance, they may not maintain that market acceptance over time if competing diagnostic tests or technologies, which
are more cost effective or are received more favorably, are introduced. Failure to achieve or maintain market acceptance and/or market
share would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition, and results
of operations.

 If we fail to increase our sales and marketing
capabilities or develop broad awareness of our diagnostic tests in a cost-effective manner, we may not be able to generate revenue growth.

 We plan to dedicate significant resources to the
expansion of our distribution network and to supporting their marketing efforts. It will negatively affect our business, financial condition,
and results of operations if our marketing efforts and expenditures do not generate a corresponding increase in revenue. In addition,
we believe that developing and maintaining broad awareness of our diagnostic tests in a cost-effective manner is critical to achieving
broad acceptance of our diagnostic tests. Promotional activities may not generate patient or physician awareness or increase revenue,
and even if they do, any increase in revenue may not offset the costs and expenses we incur in building our brand. If we fail to successfully
promote, maintain and protect our brand, we may fail to attract or retain the physician acceptance necessary to realize a sufficient return
on our brand building efforts, or to achieve the level of brand awareness that is critical for broad use of our diagnostic tests, which
in turn could have a material adverse effect on our business, financial condition and results of operations.

 If we cannot maintain our current relationships,
or enter into new relationships, with CROs, universities, clinics, laboratories or tissue sample banks, our revenue prospects could be
reduced.

 We engage contract research organizations, universities,
clinics, and tissue banks to enroll or access patients primarily to support clinical studies. The ability of our contractors to enroll
patients in clinical studies may also fluctuate in the future, which could have a material adverse effect on our product development timelines,
financial condition and results of operations. In addition, the termination of these relationships could result in a temporary or prolonged
delay in commercial launches resulting in a loss of revenue.

 We engage in conversations with diagnostic laboratories
regarding potential commercial opportunities on an ongoing basis. There is no assurance that any of these conversations will result in
a commercial agreement, or if an agreement is reached, that the resulting relationship will be successful or that clinical or research
studies conducted as part of the engagement will produce successful outcomes. Speculation in the industry about our existing or potential
relationships with diagnostic laboratories and biopharmaceutical companies can also be a catalyst for adverse speculation about us, our
tests and our technology, which can adversely affect our reputation and our business.

 We need to ensure strong product performance
and quality to maintain and grow our business.

 We will need to maintain and continuously improve
the performance of our diagnostic tests to maintain CE marking or other applicable market approvals and compliance with QMS (ISO 13485).
Poor product performance and quality could lead to customer dissatisfaction, adversely affect our reputation and revenues, and increase
our service and distribution costs and working capital requirements. Our diagnostic tests may contain errors or defects, and while we
have made efforts to control them extensively, we cannot assure that our current diagnostic tests, or those developed in the future, will
not have performance problems. Any performance issues with our diagnostic tests now or in the future will increase our costs and accordingly
adversely affect our business, financial condition, and results of operations.

 The sizes of the markets for our diagnostic
tests and services and any future diagnostic tests and services may be smaller than we estimate and may decline.

 Our estimates of the annual total addressable
market for our diagnostic tests and services are based on a number of internal and third-party estimates and assumptions, including, without
limitation, the assumed prices at which we can sell our diagnostic tests and services in the market. While we believe our assumptions
and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting
our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.

 As a result, our estimates of the annual total
addressable market for our diagnostic tests and services in different market segments may prove to be incorrect. If the actual number
of patients who would benefit from our diagnostic tests, the price at which we can sell them or the annual total addressable market for
them is smaller than we have estimated, it may impair our sales growth and negatively affect our business, financial condition and results
of operations.

 We have a significant customer concentration,
with a limited number of customers accounting for a large portion or all of our revenues.

 We derive a large portion or all of our revenues
from a few major customers. For the year ended December 31, 2024, 100% of our development service revenue came from Immunovia, and 73%
and 18% of our product sales revenue came from LabCorp and Cambridge, respectively. For the year ended December 31, 2023, we generated
100% of our revenue from one customer, in the context of a partnership with Immunovia AB (Sweden). In 2022, Immunovia AB partnered with
Proteomedix to leverage Proteomedix's research and development capabilities and to advance their research and development efforts.

 There are inherent risks whenever a large percentage
of the total revenue is concentrated with a few customers. It is not possible for us to predict the future level of demand for our product
that will be generated by these customers or the future demand for our product by these customers. If any of these customers' demands
decline or delayed demands due to market, economic or competitive conditions, we could be pressured to reduce our prices, which could
have an adverse effect on our financial position and could negatively affect our revenues and results of operations. If any of our largest
customers terminate the purchase of our product, such termination would materially negatively affect our revenues, results of operations
and financial condition.

 Our results of operations will be materially
harmed if we are unable to accurately forecast customer demand for, and utilization of, our diagnostic tests and manage our inventory.

 To ensure adequate inventory supply, we must forecast
inventory needs and manufacture our diagnostic tests based on our estimates of future demand for our diagnostic tests. Our ability to
accurately forecast demand for them could be negatively affected by many factors, including our failure to accurately manage our expansion
strategy, product introductions by competitors, an increase or decrease in customer demand for our diagnostic tests or for those of our
competitors, our failure to accurately forecast customer acceptance of new diagnostic tests, unanticipated changes in general market conditions
or regulatory matters and weakening of economic conditions or consumer confidence in future economic conditions. Inventory levels in excess
of customer demand may result in inventory write-downs or write-offs, which would cause our gross margin to be adversely affected and
could impair the strength of our brand. Conversely, if we underestimate customer demand for our diagnostic tests, our supply chain, manufacturing
partners and/or internal manufacturing team may not be able to deliver components and diagnostic tests to meet our requirements, and this
could result in damage to our reputation, sales growth and customer relationships. In addition, if we experience a significant increase
in demand, additional supplies of raw materials or additional manufacturing capacity may not be available when required on terms that
are acceptable to us, or at all, or suppliers may not be able to allocate sufficient capacity in order to meet our increased requirements,
which will adversely affect our business, financial condition and results of operations.

 The timing of our new product offerings
is uncertain.

 There can be no assurance that our development
activities will always produce tests with the sensitivity and specificity necessary to be clinically and commercially competitive, or
that any test will result in a commercially successful product. In addition, before we can develop diagnostic tests for new cancers
or other diseases and commercialize any new products, we will need to:

 conduct substantial research and development;

 conduct analytical and clinical performance testing (verification and validation); and

 expend significant funds.

 Our product development process involves a high
degree of risk and may take several years in some instances. Our product development efforts may fail for many reasons, including,
but not limited to:

 failure of the product at the research or development phase;

 difficulty in accessing samples, especially samples with known clinical results; or

 lack of clinical performance data to support the safety and effectiveness of the product.

 Few research and development projects result in
commercial products, and success in early clinical trials often is not replicated in later studies. At any point, we may abandon
development of a product candidate, or we may be required to expend considerable resources repeating clinical trials, which would adversely
impact the timing for generating potential revenues from those product candidates. In addition, as we develop products, we will have
to make significant investments in product development. If a clinical validation study fails to demonstrate the prospectively defined
endpoints of the study, we might choose to abandon the development of the product or product feature that was the subject of the clinical
trial, which could harm its business. In addition, our competitors may develop and commercialize competing products faster than we
are able to do so.

 Our access to samples may hinder our ability
to research, develop, and commercialize future products.

 Our planned and future products are focused primarily
on exploitation of blood plasma or serum as a medium for both biomarker identification and validation and ultimately for our commercial
testing applications. Our clinical development relies on our ability to secure access to high quality, well-characterized samples, as
well as information pertaining to the samples associated clinical outcomes. Our competitors have demonstrated their ability to obtain
these samples and often compete with us for access to such samples. Additionally, the process of negotiating access to samples is lengthy
since it typically involves numerous parties and approval levels to resolve complex issues such as usage rights, institutional review
board (ethical) approval, privacy rights, publication rights, intellectual property ownership and research parameters. If we are not able
to negotiate access to samples with hospitals, clinical partners, or other companies on a timely basis, or at all, or if competitors secure
access to these samples before us, then our ability to research, develop, and commercialize future products will be limited or delayed.

 Adherence to complex test protocols is required.

 We validate our tests in our lab in Switzerland
using blood samples obtained from a variety of sources. Tests results can be affected by a number of variables including how the blood
is extracted, how the blood is handled, the type of test tube used, the number and speed of centrifuge spins, the temperature the blood
is exposed to during processing, the concentration of the reagents, and the timing of reagent use. All of these and other variables in
the process are set forth in an assay protocol that we provide to our distributor lab partners along with training in proper compliance.
If, due to human or equipment failure, there is material deviation from the protocols, the accuracy of our tests can be negatively impacted.
If that occurs, the reputation of our product and our revenue could be negatively impacted.

 Risks Related to our Business and Industry

 Our reliance on third parties heightens the risks faced by our
business.

 We rely on suppliers, vendors, subcontractors,
and partners for certain key aspects of our business, including support for information technology systems and certain human resource
functions. We do not control these partners, but we depend on them in ways that may be significant to us. However, if these parties fail
to meet their defined obligations to us, we may fail to receive the expected benefits. In addition, if any of these third parties fails
to comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held
responsible for such violations as well. This risk is particularly serious in emerging markets, where corruption is often prevalent and
where many of the third parties on which we rely do not have internal compliance resources comparable to our own. Any such failures by
third parties, in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.

 We are dependent on third parties to market,
distribute and sell our product.

 Our ability to receive revenues is dependent upon
the sales and marketing efforts of co-marketing partners and third-party distributors. If we fail to reach an agreement with any commercialization
partner, or upon reaching such an agreement that partner fails to sell a large volume of our product, it may have a negative impact on
our business, financial condition, and results of operations.

 We have no experience manufacturing our
product on a commercial scale and are dependent on third parties for the manufacture of our product. If we experience problems with any
of these third parties, they could delay our ability to sell our product.

 We do not have any manufacturing facilities. We
will rely on third-party manufacturers for commercial supply of Proclarix.

 We may be unable to establish agreements with
third-party manufacturers for commercial supply on terms favorable to us, or at all. Even if we are able to establish agreements with
third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

 reliance on the third party for regulatory compliance and through quality management system;

 the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines; and

 the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

 Third-party manufacturers may not be able to comply
with U.S. cGMPs, QSR or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers,
to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product, could result in
sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of
approvals, license revocation, seizures or product recalls, operating restrictions and criminal prosecutions, any of which could adversely
affect supplies of our product and harm our business and results of operations.

 Our product may compete with other products and/or
product candidates for access to these manufacturing facilities. There are a limited number of manufacturers that operate under cGMPs
and that might be capable of manufacturing for us.

 Any performance failure on the part of our manufacturers,
including a failure that may not relate specifically to our product, could adversely impact our ability to generate commercial sales.
If our contract manufacturers cannot perform as agreed, we may be required to replace that manufacturer.

 Our anticipated future dependence upon others
for the manufacture of our product may adversely affect our future profit margins and our ability to commercialize our product on a timely
and competitive basis.

 Moreover, our manufacturers and suppliers may
experience difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of
supply of our product.

 Manufacturing risks may adversely affect
our ability to manufacture our product and could reduce our gross margin and profitability.

 Our business strategy depends on our ability to
manufacture our product in sufficient quantities and on a timely basis so as to meet consumer demand, while adhering to product quality
standards, complying with regulatory requirements and managing manufacturing costs. We are subject to numerous risks relating to our manufacturing
capabilities, including:

 quality or reliability defects in product components that we source from third-party suppliers, including manufacturing compliance with federal and state regulations;

 our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms;

 our failure to increase production of product to meet demand;

 our inability to modify production lines to enable us to efficiently implement changes in response to regulatory requirements; and

 Potential damage to or destruction of our manufacturing equipment or manufacturing facility.

 If demand for our product increases in the future,
we will have to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing processes.
If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins
could fluctuate or decline. Manufacturing of our product may require the modification of our production lines, the hiring of specialized
employees, the identification of new suppliers for specific components, or the development of new manufacturing technologies. It may not
be possible for us to manufacture this product at a cost or in quantities sufficient to make this product commercially viable. Any of
these factors may affect our ability to manufacture our product and could reduce our gross margin and profitability.

 We maintain single supply relationships
for certain key components, and our business and operating results could be harmed if supply is restricted or ends or the price of raw
materials used in its manufacturing process increases.

 We are dependent on sole suppliers or a limited
number of suppliers for certain components that are integral to our finished product. If these or other suppliers encounter financial,
operating or other difficulties or if our relationship with them changes, we may be unable to quickly establish or qualify replacement
sources of supply and could face production interruptions, delays and inefficiencies. In addition, technology changes by our vendors could
disrupt access to the required manufacturing capacity or require expensive, time-consuming development efforts to adapt and integrate
new equipment or processes. Our growth may exceed the capacity of one or more of these suppliers to produce the needed equipment and materials
in sufficient quantities to support our growth. Any one of these factors could harm our business and growth prospects.

 We may not be able to manage our manufacturing
and supply chain effectively, which would harm our results of operations.

 We must accurately forecast market demand for
our product in order to have adequate product inventory available to fulfil our timeline and customer orders timely. Our forecasts will
be based on multiple assumptions that may cause our estimates to be inaccurate, and thus affect our ability to ensure adequate manufacturing
capability to satisfy market demand. Any material delay in our ability to obtain timely product inventories from our manufacturing facility
and our ingredient suppliers could prevent us from satisfying increased consumer demand for our product, resulting in material harm to
our brand and business. In addition, we will need to continuously monitor our inventory and product mix against forecasted demand to avoid
having inadequate product inventory or having too much product inventory on hand. If we are unable to manage our supply chain effectively,
our operating costs may increase materially.

 We may in the future have conflicts with
our current or future partners or third-party providers that could delay or prevent the commercialization of our current product.

 We may in the future have conflicts with our current
or future partners or third-party providers, such as conflicts concerning the achievement of milestones, the interpretation of contractual
obligations, payments for services, development obligations or the ownership of intellectual property developed during our collaboration.
If any conflicts arise with any of our partners, such partner may act in a manner that is adverse to our best interests. Any such disagreement
could result in one or more of the following, each of which could delay or prevent the commercialization of our current product, and in
turn prevent us from generating revenues:

 unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

 uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;

 unwillingness by the partner to cooperate in the manufacture of the product, including providing us with product data or materials;

 unwillingness on the part of a partner to keep us informed regarding the progress of its commercialization activities or to permit public disclosure of the results of those activities;

 initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or

 attempts by either party to terminate the agreement.

 Product liability lawsuits against us could
cause us to incur substantial liabilities and to limit commercialization of our product.

 We face an inherent risk of product liability
exposure related to the commercialization of our product. Product liability claims may be brought against us by patients, healthcare providers
or others using, administering, or selling our product.

 In addition, we face an inherent risk of product
liability as a result of the marketing and sale of Proteomedix's diagnostic tests and services. For example, we may be sued if the
diagnostic tests or services cause or are perceived to cause injury or are found to be otherwise unsuitable during manufacturing, marketing
or sale. Any such product liability claim may include allegations of defects in manufacturing, defects in design, a failure to warn of
dangers inherent in the product, negligence, strict liability, or a breach of warranties. In addition, we may be subject to claims against
us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, medical personnel,
care partners and patients collect samples for our diagnostic tests. If these medical personnel, care partners or patients are not properly
trained, are negligent or use our diagnostic tests incorrectly, the capabilities of such tests may be diminished, or the patient may suffer
critical injury. We may also be subject to claims that are caused by the activities of our suppliers, such as those who provide us with
components and sub-assemblies for our diagnostic tests.

 If we cannot successfully defend ourselves against
product liability claims, we may incur substantial liabilities or be required to limit or halt the marketing and sale of our diagnostic
tests and services. Even a successful defense would require significant financial and management resources. Regardless of the merits or
eventual outcome, liability claims may result in:

 decreased demand for our product;

 injury to our reputation and significant negative media attention;

 significant costs to defend the related litigation;

 substantial monetary awards to patients;

 loss of revenue;

 diversion of management and scientific resources from our business operations;

 the inability to commercialize our product;

 the initiation of investigations by regulators; and

 product recalls, withdrawals or labeling, marketing, or promotional restrictions.

 We have product liability insurance coverage at
a level that we believe is customary for similarly situated companies and adequate to provide us with insurance coverage for foreseeable
risks. However, we may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability
that may arise, and such insurance may not be adequate to cover all liabilities that we may incur. Furthermore, we intend to expand our
insurance coverage for product to include the sale of commercial product if we obtain regulatory approval for our product candidates in
development, but we may be unable to obtain commercially reasonable product liability insurance for any products that receive regulatory
approval. Large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful
product liability claim, or series of claims brought against us, particularly if judgments exceed our insurance coverage, could decrease
our cash, and adversely affect our business.

 We may engage in acquisitions that could
disrupt our business, cause dilution to our stockholders or reduce our financial resources.

 In the future, we may enter into transactions
to acquire other businesses, products or technologies. If we do identify suitable candidates, we may not be able to make such acquisitions
on favorable terms, or at all. Any acquisitions we make may fail to strengthen our competitive position and these transactions may be
viewed negatively by customers or investors. We may decide to incur debt in connection with an acquisition or issue our common stock or
other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.
We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we
may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies, and operations
into our existing business in an effective, timely and non-disruptive manner. Acquisitions may also divert management attention from day-to-day
responsibilities, increase our expenses and reduce our cash available for operations and other uses. We cannot predict the number, timing
or size of future acquisitions or the effect that any such transactions might have on our operating results.

 Security threats to our information technology
infrastructure and/or our physical buildings could expose us to liability and damage our reputation and business.

 It is essential to our business strategy that
our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners
to be secure. Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security
threats. We may face cyber-attacks that attempt to penetrate our network security, sabotage, or otherwise disable our, product and services,
misappropriate our or our customers' and partners' proprietary information, which may include personally identifiable information,
or cause interruptions of our internal systems and services. Despite security measures, we also cannot guarantee the security of our physical
buildings. Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network infrastructure
and our ability to deploy our product and services, harm our relationship with customers and partners that are affected, and expose us
to financial liability.

 Additionally, there are a number of state, federal
and international laws governing the collection, use, processing and protection of health information and personal data. Most states have
data security breach laws requiring data protection measures and potentially requiring notification to regulators and impacted consumers.
The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical
Health Act of 2009 (collectively, "HIPAA"), imposes limitations on the use and disclosure of an individual's healthcare
information "covered entities," which include by healthcare providers who submit certain standard transactions electronically
(mostly related to claims for payment from health insurers), healthcare clearinghouses, and health insurance plans, and also grants individuals
rights with respect to their health information. Although we do not currently submit standard transactions electronically and therefore
are not a HIPAA covered entity, HIPAA has been in effect for over 20 years and accordingly individuals expect that providers of health
care items or services will safeguard their health information in accordance with HIPAA. Moreover, many states' laws impose similar
or more stringent limitations on uses and disclosures of healthcare information than does HIPAA, and such laws also provide individuals
rights to access, amend, and withhold sharing of their health information. HIPAA also requires reporting of certain impermissible uses
and disclosures of health information, including security breaches, to affected individuals, the Office for Civil Rights of the U.S. Department
of Health and Human Services, and in some cases the media. Notification is not required under HIPAA if the health information that is
improperly used or disclosed is deemed secured in accordance with encryption or other standards developed by the U.S. Department of Health
and Human Services. Most states also have laws requiring notification of affected individuals and/or state regulators in the event of
a breach of personal information, which is a broader class of information than the health information protected by HIPAA. Many state laws
impose significant data security requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal
information. Activities outside of the U.S. implicate local and national data protection standards, impose additional compliance requirements
and generate additional risks of enforcement for non-compliance. We may be required to expend significant capital and other resources
to ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate
problems caused by such breaches.

 We will need to grow the size of our organization
in the future, and we may experience difficulties in managing this growth.

 As of May 30, 2025, we had 5 full-time and 2 subcontracted
employees. We will need to increase the size of our organization in order to support our continued commercialization of our product. As
our commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales,
marketing, financial and other resources may increase. Our management, personnel and systems currently in place may not be adequate to
support this future growth. Future growth would impose significant added responsibilities on members of management, including:

 identifying, recruiting, maintaining, motivating, and integrating additional employees;

 managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;

 improving our managerial, development, operational, information technology and finance systems; and

 expanding our facilities.

 If our operations expand, we will also need to
manage additional relationships with various strategic partners, suppliers and other third parties. Our future financial performance and
our ability to commercialize our product and to compete effectively will depend, in part, on our ability to manage any future growth effectively,
as well as our ability to develop a sales and marketing force when appropriate. To that end, we must be able to hire, train and integrate
additional management, manufacturing, administrative and sales and marketing personnel. The failure to accomplish any of these tasks could
prevent us from successfully growing our company.

 Our future success depends on our ability
to retain our executive officers and to attract, retain and motivate qualified personnel.

 We are highly dependent upon our personnel and
executive officers. We have not obtained, do not own, nor are we the beneficiary of, key-person life insurance. Our future growth and
success depend on our ability to recruit, retain, manage and motivate our employees. The loss of any member of our senior management team
or the inability to hire or retain experienced management personnel could compromise our ability to execute our business plan and harm
our operating results. Because of the specialized scientific and managerial nature of our business, we rely heavily on our ability to
attract and retain qualified scientific, technical and managerial personnel. The competition for qualified personnel in the biotechnology
field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary for the development
of our business.

 Members of our management team and board
of directors have significant experience as founders, board members, officers, or executives of other companies. As a result, certain
of those people have been and may become involved in proceedings, investigations and litigation relating to the business affairs of the
companies with which they were, are, or may in the future be, affiliated. This may have an adverse effect on us, could damage our reputation
and business.

 During the course of their careers, members of
our management team and Board have had significant experience as founders, board members, officers or executives of other companies. As
a result of their involvement and positions in these companies, certain persons were, are now, or may in the future become, involved in
litigation, investigations or other proceedings relating to the business affairs of such companies or transactions entered into by such
companies. Any such litigation, investigations or other proceedings may divert our management team's and board's attention
and resources away from our affairs and may negatively affect our reputation and our business.

 Inadequate funding for the FDA, the SEC
and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent review of regulatory
submissions in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of
our business may rely, which could negatively impact our business.

 The ability of the FDA to review regulatory submissions
can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and
accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in
recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely is
subject to the political process, which is inherently fluid and unpredictable.

 Disruptions at the FDA and other agencies may
also slow the time necessary for regulatory submissions to be reviewed by necessary government agencies, which would adversely affect
our business. For example, over the last several years, including beginning on December 22, 2018, the U.S. government has shut down several
times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees
and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely
review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations
as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in
order to properly capitalize and continue our operations.

 We may be adversely affected by natural
disasters, pandemics and other catastrophic events, and by man-made problems such as terrorism and acts of war, that could disrupt our
business operations and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

 If a disaster, power outage or other event occurred
that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as enterprise
financial systems, manufacturing resource planning or enterprise quality systems, or that otherwise disrupted operations, it may be difficult
or, in certain cases, impossible for us to continue our business for a substantial period of time. Our contract manufacturers' and
suppliers' facilities are located in multiple locations, where other natural disasters or similar events, such as blizzards, tornadoes,
fires, explosions or large-scale accidents or power outages, and other public health emergencies could severely disrupt our operations
and have a material adverse effect on our business, financial condition, operating results and prospects. A public health emergency could
also affect the operations of the FDA and other regulatory or public health authorities, resulting in delays to meetings and ultimately
review of regulatory submissions.

 Our employees, independent contractors,
principal investigators, consultants, and vendors and engage in misconduct or other improper activities, including noncompliance with
regulatory standards and requirements.

 We are exposed to the risk that our employees,
independent contractors, consultants, and vendors may engage in fraudulent or other illegal activity. Misconduct by these persons could
include intentional, reckless, or negligent conduct or unauthorized activity that violates laws or regulations, including those laws requiring
the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities; manufacturing standards; federal,
state and foreign healthcare fraud and abuse laws and data privacy; or laws that require the true, complete and accurate reporting of
financial information or data. In particular, sales, marketing and other business arrangements in the healthcare industry are subject
to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws may restrict or prohibit
a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales
commission, customer incentive programs, patient rebate programs, and other business arrangements. Activities subject to these laws also
involve the improper use of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which
could result in regulatory sanctions or other actions or lawsuits stemming from a failure to comply with such laws or regulations, and
serious harm to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in connection with government
contracts and require certain contractors to maintain a code of business ethics and conduct. If any such actions are instituted against
us, we may have to terminate employees or others involved and the impact of such termination can result in our experiencing delays and
additional costs associated with replacing the services being provided. If we are not successful in defending ourselves or asserting our
rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative
penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs,
FDA debarment, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any
of which could adversely affect our ability to operate our business and our operating results.

 Macroeconomic pressures in the markets in
which we operate, including, but not limited to, the current conflicts in Ukraine and the Middle East may alter the ways in which we conduct
our business operations and manage our financial capacities.

 To varying degrees, the ways in which we conduct
our business operations and manage our financial capacities are influenced by macroeconomic conditions that affect companies directly
involved in or providing services related to the drug development. For example, real GDP growth, business and investor confidence, the
conflicts in Ukraine and the Middle East, inflation, employment levels, oil prices, interest rates, tax rates, availability of consumer
and business financing, housing market conditions, foreign currency exchange rate fluctuations, costs for items such as fuel and food
and other macroeconomic trends can adversely affect not only our decisions and ability to engage in research and development and clinical
trials, but also those of our management, employees, third-party contractors, manufacturers and suppliers, competitors, stockholders and
regulatory authorities. In addition, geopolitical issues around the world and how our markets are positioned can also impact the macroeconomic
conditions and could have a material adverse impact on our financial results.

 Economic uncertainty may adversely affect
our access to capital, cost of capital and ability to execute our business plan as scheduled.

 Generally, worldwide economic conditions remain
uncertain. Access to capital markets is critical to our ability to operate. Traditionally, biotechnology companies have funded their research,
development and commercialization expenditures through raising capital in the equity markets. Declines and uncertainties in these markets
in the past have severely restricted raising new capital and have affected companies' ability to continue to expand or fund existing
research, development, and commercialization efforts. We require significant capital for the commercialization of our product. The general
economic and capital market conditions, both in the U.S. and worldwide, have been volatile in the past and at times have adversely affected
our access to capital and increased the cost of capital. There is no certainty that the capital and credit markets will be available to
raise additional capital on favorable terms. If economic conditions become worse, our future cost of equity or debt capital and access
to the capital markets could be adversely affected. In addition, if we are unable to access the capital markets on favorable terms, our
ability to execute our business plan as scheduled would be compromised. Moreover, we rely and intend to rely on third-parties, including
CROs, CMOs and other important vendors and consultants. Global economic conditions may result in a disruption or delay in the performance
of our third-party contractors and suppliers. If such third-parties are unable to adequately satisfy their contractual commitments to
us in a timely manner, our business could be adversely affected.

 Conditions in the global economy may adversely
affect our business, financial condition and results of operations.

 Although demand for in vitro diagnostics is considered
inelastic in developed economies, the in vitro diagnostic industry that we sell to may be affected by material changes in supply, market
prices, exchange rates and general economic conditions. Delays or reductions in our customers' purchasing or shifts to lower-cost
alternatives that result from tighter economic market conditions would reduce demand for our product and services and could, consequently,
have a material adverse effect on our business, financial condition, and results of operations.

 Misconduct and errors by our current and
former employees and our third-party service providers could cause a material adverse effect on our business and reputation.

 Our employees and third-party service providers
are integral to our business operations, including confidential information. If any such information were leaked to unintended recipients
due to human error, theft, malicious sabotage or fraudulent manipulation, we may be subject to liability for loss of such information.
Further, if any of our employees or third-party service providers absconded with our proprietary data or know-how in order to compete
with us, our competitive position may be materially and adversely affected.

 Any improper conduct or use of funds by any
of our employees or third-party service providers in contravention of our protocols and policies may lead to regulatory and disciplinary
proceedings involving us. We may be perceived to have facilitated or participated in such conduct and we could be subject to liability,
damages, penalties and reputational damage. It is impossible to completely identify and eradicate all risks of misconduct or human errors,
and our precautionary measures may not be able to effectively detect and prevent such risks from happening.

 The occurrence of any of the above risks could
result in a material adverse effect on our business and results of operations, as we are exposed to potential liability to borrowers and
investors, reputational damage, regulatory intervention, financial harm. Our ability to attract new and retain existing borrowers and
investors and operate as an ongoing concern may be impaired.

 Our industry is subject to rapid change,
which could make our solutions and the diagnostic tests we develop and services we offer, obsolete. If we are unable to continue to innovate
and improve our diagnostic tests and services, we could lose customers or market share.

 Our industry is characterized by rapid changes,
including technological and scientific breakthroughs, frequent new product introductions and enhancements and evolving industry standards,
all of which could make our current diagnostic tests and others we are developing obsolete. Our future success will depend on our ability
to keep pace with the evolving needs of our customers on a timely and cost-effective basis and to pursue new market opportunities that
develop as a result of scientific and technological advances. In recent years, there have been numerous advances in technologies relating
to the diagnosis and treatment of cancer. There have also been advances in methods used to analyze very large amounts of molecular information
as well as new imaging-based technologies used of the early assessment and monitoring of disease. We must continuously enhance our offerings
and develop new and improved diagnostic tests to keep pace with evolving standards of care. If we do not leverage or scale our sample
and data biobank, discover new diagnostic biomarkers or applications, or update our diagnostic tests to reflect new scientific knowledge,
including about prostate cancer biology, and information about new cancer therapies or relevant clinical trials, our diagnostic tests
could become obsolete and sales of our current diagnostic tests and any new tests we develop could decline or fail to grow as expected.
This failure to make continuous improvements to our diagnostic tests to keep ahead of those of our competitors could result in the loss
of customers or market share that would adversely affect our business, financial condition, and results of operations. The development
of new liquid biopsy and imaging technologies could negatively impact demand for our product.

 In the event that our product is the subject of
guidelines, clinical studies or scientific publications that are unhelpful or damaging, or otherwise call into question the benefits of
our product, we may have difficulty in convincing prospective customers to adopt our test. Moreover, the perception by the investment
community or shareholders that recommendations, guidelines, or studies will result in decreased use of our product could adversely affect
the prevailing market price for our common stock.

 We face competition from many sources, including
larger companies, and we may be unable to compete successfully.

 There are a number of diagnostic solutions companies
in the United States, Europe and Asia. Notable competitors in the United States include, but are not limited to OPKO Health, Beckman Coulter,
BioTechne, MdxHealth, A3P Biomedical AB. These competitors all provide diagnostic tests or testing services to hospitals, researchers,
clinicians, laboratories, and other medical facilities. Many of these organizations are significantly larger with greater financial and
personnel resources than us and enjoy significantly greater market share and have greater resources than we do. As a consequence, they
may be able to spend more on product development, marketing, sales and other product initiatives than we can. Some of our competitors
have:

 substantially greater name recognition;

 broader, deeper, or longer-term relations with healthcare professionals, customers, and third-party payers;

 more established distribution networks;

 additional lines of diagnostic tests and the ability to offer rebates or bundle them to offer greater discounts or other incentives to gain a competitive advantage;

 greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for diagnostic tests; and

 greater financial and human resources for product development, mergers and acquisitions, sales and marketing and possible patent litigation.

 Our continued success depends on our ability to:

 Further penetrate the diagnostic solutions market and increase utilization of our diagnostic tests;

 attract and retain a sufficient number of qualified employees;

 maintain and widen our technology lead over competitors by continuing to innovate and deliver new product enhancements on a continuous basis; and

 cost-effectively manufacture our diagnostic tests and their component parts as well as drive down the cost of service.

 As we attain greater commercial success, our competitors
are likely to develop diagnostic tests that offer features and functionality similar to our diagnostic tests that are currently on the
market. Improvements in existing competitive diagnostic tests or the introduction of new competitive diagnostic tests may make it more
difficult for us to compete for sales, particularly if those competitive diagnostic tests demonstrate better reliability, convenience
or effectiveness or are offered at lower prices.

 Performance issues, service interruptions
or price increases by our shipping carriers and warehousing providers could adversely affect our business and harm our reputation and
ability to provide our services on a timely basis.

 Expedited, reliable shipping and delivery services
and secure warehousing are essential to our operations. We rely heavily on providers of transport services for reliable and secure point-to-point
transport of our diagnostic tests to our customers and for tracking of these shipments, and from time to time require warehousing for
our diagnostic tests, sample collection kits and supplies. Should a carrier encounter delivery performance issues such as loss, damage,
or destruction of any systems, it would be costly to replace such systems in a timely manner and such occurrences may damage our reputation
and lead to decreased demand for our diagnostic tests and increased cost and expense to our business. In addition, any significant increase
in shipping or warehousing rates could adversely affect our operating margins and results of operations. Similarly, strikes, severe weather,
natural disasters, civil unrest and disturbances or other service interruptions affecting delivery or warehousing services we use would
adversely affect our ability to process orders for our diagnostic tests on a timely basis.

 For our clinical studies, we rely on commercial
courier delivery services to transport samples to our laboratory facility in a timely and cost-efficient manner and if these delivery
services are disrupted, our business will be harmed. Disruptions in delivery service, whether due to labor disruptions, bad weather, natural
disaster, civil unrest or disturbances, terrorist acts or threats or for other reasons could adversely affect specimen integrity and our
ability to process samples in a timely manner and to service our customers, and ultimately our reputation and our business. In addition,
if we are unable to continue to obtain expedited delivery services on commercially reasonable terms, our operating results may be adversely
affected.

 We rely on software hosting our online risk calculator
needed to be accessed by the user to calculate the test result. Any internet service interruption or hardware failure could affect availability
of the online resource and thus negatively impact our business.

 Cost-containment efforts of our customers,
purchasing groups and governmental purchasing organizations could have a material adverse effect on our future sales and profitability.

 In an effort to reduce costs, many hospitals in
the United States have become members of GPOs and Integrated Delivery Networks (IDNs). GPOs and IDNs negotiate pricing arrangements with
medical device companies and distributors and then offer these negotiated prices to affiliated hospitals and other members. GPOs and IDNs
typically award contracts on a category-by-category basis through a competitive bidding process. Bids are generally solicited from multiple
providers with the intention of driving down pricing or reducing the number of vendors. Due to the highly competitive nature of the GPO
and IDN contracting processes, we may not be able to obtain new contract positions with major GPOs and IDNs. Furthermore, the increasing
leverage of organized buying groups may reduce market prices for our diagnostic tests, thereby reducing our revenue and margins.

 While having a contract with a GPO or IDN for
a given product category can facilitate sales to members of that GPO or IDN, such contract positions can offer no assurance that any level
of sales will be achieved, as sales are typically made pursuant to individual purchase orders. Even when a provider is the sole contracted
supplier of a GPO or IDN for a certain product category, members of the GPO or IDN are generally free to purchase from other suppliers.
Furthermore, GPO and IDN contracts typically are terminable without cause by the GPO or IDN upon 60 to 90 days' notice. Accordingly,
the members of such groups may choose to purchase alternative diagnostic tests due to the price or quality offered by other companies,
which could result in a decline in our revenue.

 We are highly dependent on our senior management
team and key personnel, and our business could be harmed if we are unable to attract and retain the personnel necessary for our success.

 We are highly dependent on our senior management
and other key personnel. Our success will depend on our ability to retain senior management and to attract and retain qualified personnel
in the future, including sales and marketing professionals, scientists, clinical specialists, and other highly skilled personnel and to
integrate current and additional personnel in all departments. The loss of members of our senior management, sales and marketing professionals,
scientists, clinical and regulatory specialists could result in delays in product development and harm our business. If we are not successful
in attracting and retaining highly qualified personnel, it would have a material adverse effect on our business, financial condition,
and results of operations.

 Our laboratory operations depend on our ability
to attract and retain highly skilled scientists and technicians. We may not be able to attract or retain qualified scientists and technicians
in the future due to the competition for qualified personnel among life science businesses, particularly near our laboratory facility
in Zurich-Schlieren, Switzerland. We also face competition from universities and public and private research institutions in recruiting
and retaining highly qualified scientific personnel.

 We may also have difficulties locating, recruiting,
or retaining qualified salespeople. Recruiting and retention difficulties can limit our ability to support our research and development
and sales programs. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have issued and
may continue to issue equity awards that vest over time. Our employment arrangements with our employees provide for at-will employment,
which means that any of our employees could leave our employment at any time, with or without notice, which may lead to more difficulty
in retaining qualified salespeople and other talent.

 We depend on our information technology
systems and any failure of these systems could harm our business.

 We depend on information technology and telecommunications
systems, including third-party cloud computing infrastructure and operating systems, for significant elements of our operations, including
our online risk analysis software.

 We have installed, and expect to expand, a number
of enterprise software systems that affect a broad range of business processes and functional areas, including systems handling human
resources, financial controls and reporting, contract management, regulatory compliance and other infrastructure operations.

 Information technology and telecommunications
systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts (such
as ransomware) and natural disasters. Moreover, despite network security and back-up measures, some of our external servers are potentially
vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionary measures we
have taken to prevent unanticipated problems that could affect our information technology and telecommunications systems, failures or
significant downtime of these systems or those used by our partners or subcontractors could prevent us from conducting our diagnostic
products development, preparing and providing reports to researchers, clinicians and our partners, billing payors, handling enquiries,
and managing the administrative aspects of our business. Any disruption or loss of information technology or telecommunications systems
on which critical aspects of our operations depend could have an adverse effect on our business and our reputation, and we may be unable
to regain or repair our reputation in the future.

 Risks Related to Our Intellectual Property

 It is difficult and costly to protect our
proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product
and/or product candidates, others could compete against us more directly, which would harm our business, possibly materially.

 Our commercial success will depend in part on
obtaining and maintaining patent protection and trade secret protection of our current product candidates and future product candidates,
the processes used to manufacture them and the methods for using them, as well as successfully defending these patents against third-party
challenges. Our ability to stop third parties from making, using, selling, offering to sell or importing our product and/or product candidates
is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

 The patent positions of biotechnology and pharmaceutical
companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.
No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the U.S. or in foreign jurisdictions
outside of the U.S. Changes in either the patent laws or interpretations of patent laws in the U.S. and other countries may diminish the
value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be enforced in the patents that may
be issued from the applications we currently license or may in the future own or license from third parties. Further, if any patents we
obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product and/or product candidates
or technology could be adversely affected.

 Others may file patent applications covering products
and technologies that are similar, identical, or competitive to ours or important to our business. We cannot be certain that any patent
application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our licensors
will not be involved in interference, opposition, re-examination, review, reissue, post grant review or invalidity proceedings before
U.S. or non-U.S. patent offices. Such proceedings are also expensive and time consuming.

 The degree of future protection for our proprietary
rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain
or keep our competitive advantage. For example:

 others may be able to make compounds/assays that are similar to our product and/or product candidates and/or assays, but that are not covered by the claims of our licensed patents;

 any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;

 any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and

 the patents of others may have an adverse effect on our business.

 We are dependent on licensed intellectual
property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing
our product and/or product candidates, if approved. If we breach any of the agreements under which we license the use, development, and
commercialization rights to our product and/or product candidates or technology from third parties or, in certain cases, we fail to meet
certain development deadlines, we could lose license rights that are important to our business.

 Proteomedix owns the patents and patent applications
detailed above in the chapter entitled "Intellectual Property". Apart from this we do not currently own any further patents,
and we are heavily reliant upon a number of license agreements under which we are granted rights to intellectual property that are important
to our business, and we may need or choose to enter into additional license agreements in the future. Our existing license agreements
impose, and we expect that future license agreements will impose on us, various development, regulatory and/or commercial diligence obligations,
payment of milestones and/or royalties and other obligations. If we fail to comply with our obligations under these agreements, or we
are subject to a bankruptcy, the licensor may have the right to terminate the license, in which event we would not be able to market products
covered by the license. Our business could suffer, for example, if any current or future licenses terminate, if the licensors fail to
abide by the terms of the license, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable
to enter into necessary licenses on acceptable terms.

 Licensing of intellectual property is of critical
importance to our business and involves complex legal, business, and scientific issues. Disputes may arise between us and our licensors
regarding intellectual property subject to a license agreement, including:

 the scope of rights granted under the license agreement and other interpretation-related issues;

 whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

 our right to sublicense patent and other rights to third parties;

 our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product and/or product candidates, and what activities satisfy those diligence obligations;

 our obligation to pursue or license others to pursue development of indications we are not currently pursuing;

 the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;

 our right to transfer or assign the license; and

 the effects of termination.

 If disputes over intellectual property that we
own or have licensed prevent or impair our ability to maintain our patents or current licensing arrangements on acceptable terms, we may
be unable to successfully develop and commercialize the affected products and/or product candidates.

 We have entered into several licenses to support
our various programs. Termination of any of these license agreements would have a material adverse impact on our ability to develop and
commercialize derived products under each respective agreement.

 We may enter into additional licenses to third-party
intellectual property that are necessary or useful to our business. Our current licenses and any future licenses that we may enter into
impose various royalty payment, milestone, and other obligations on us. Under some license agreements, we may not control prosecution
of the licensed intellectual property or may not have the first right to enforce the intellectual property. In those cases, we may not
be able to adequately influence patent prosecution or enforcement or prevent inadvertent lapses of coverage due to failure to pay maintenance
fees. If we fail to comply with any of our obligations under a current or future license agreement, the licensor may allege that we have
breached our license agreement and may accordingly seek to terminate our license. Termination of any of our current or future licenses
could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to
develop and commercialize a product candidate or product, if approved, as well as harm our competitive business position and our business
prospects. Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual
property and information related to the product candidate being developed under the license, such as regulatory information.

 The agreements under which we license intellectual
property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple
interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope
of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations
under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations
and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current
licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected products
and/or product candidates.

 In addition, if our licensors fail to abide by
the terms of the license, if the licensors fail to prevent infringement by third parties, if the licensed patents or other rights are
found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms, our business could suffer.
Moreover, our licensors may own or control intellectual property that has not been licensed to us, and, as a result, we may be subject
to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor's rights.

 Similarly, if we are unable to successfully obtain
rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have
to seek alternative options, such as developing new products and/or product candidates with design-around technologies, which may require
more time and investment, or abandon development of the relevant research programs or products and/or product candidates and our business,
financial condition, results of operations and prospects could suffer.

 Some of the intellectual property owned
by Proteomedix and/or covered by our licenses concerns patent applications and provisional applications. We cannot assure investors that
any of the currently pending or future patent applications will result in granted patents, nor can we predict how long it will take for
such patents to be granted.

 Some of intellectual property covered by our licenses
concerns certain specified patent rights (including patent applications, provisional patent applications and PCT patent applications).
While in some instances, the licensors have agreed to assume responsibility for the preparation, filing, prosecution and maintenance of
patent applications covered by the licensed patent rights, we cannot be certain as to when or if final patents will be issued for those
patent applications covered by the licensed patent rights. However, the licensors may not successfully prosecute certain patent applications,
the prosecution of which they control, under which we are only a licensee and on which our business substantially depends. Even if patents
issue from these applications, there is no assurance that the patents will be free from defects or survive validity or enforceability
challenges, the licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may
fail to prove infringement or may fail to defend against counterclaims of patent invalidity or unenforceability.

 Moreover, it is possible that the patent applications
owned by Proteomedix and/or licensed pending patent applications will not result in granted patents, and even if such pending patent applications
grant as patents, they may not provide a basis for intellectual property protection of commercially viable vaccine products or may not
provide us with any competitive advantages. Further, it is possible that, for any of the patents that may be granted in the future, others
will design around the licensed patent rights or identify methods of diagnosis or for preventing or treating infectious diseases that
do not concern the rights covered by our patents and/or licenses. Further, we cannot assure investors that other parties will not challenge
any patents granted to Proteomedix or the licensors or that courts or regulatory agencies will hold Proteomedix and/or licensor's
patents to be valid or enforceable. We cannot guarantee investors that, if required to defend the covered patents, we will have the funds
to or be successful in defending challenges made against the Proteomedix and/or licensed patents and patent applications. Any successful
third-party challenge to the Proteomedix and/or licensed patents could result in the unenforceability or invalidity of such patents, or
to such patents being interpreted narrowly or otherwise in a manner adverse to our interests. Our ability to establish or maintain a technological
or competitive advantage over our competitors may be diminished because of these uncertainties.

 Even if patents are issued based on patent
applications to which we have been granted a license or owned by Proteomedix, because the patent positions of diagnostic methods and/or
pharmaceutical and biotechnology products are complex and uncertain, we cannot predict the scope and extent of patent protection for our
product and/or product candidates.

 Any patents that may be issued based on patent
applications that we have been granted licenses to or owned by Proteomedix will not ensure sufficient protection with respect to our activities
for a number of reasons, including without limitation the following:

 any issued patents may not be broad or strong enough to prevent competition from other diagnostic and/or vaccine products including identical or similar products;

 if patents are not issued or if issued patents expire, there would be no protections against competitors making generic equivalents;

 there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;

 there may be other patents existing, now or in the future, in the patent landscape for our product and/or product candidates that we seek to commercialize or develop, if any, that will affect our freedom to operate;

 if patents that we have been granted licenses to are challenged, a court could determine that they are not valid or enforceable;

 a court could determine that a competitor's technology or product does not infringe patents that we have been granted licenses to;

 patents to which we have been granted licenses could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing; and

 if we encounter delays in our development or clinical trials, the period of time during which we could market our product under patent protection would be reduced.

 Obtaining and maintaining patent protection
depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent
agencies, and patent protection could be reduced or eliminated for noncompliance with these requirements.

 Periodic maintenance fees on any issued patent
are due to be paid to the United States Patent and Trademark Office ("USPTO") and foreign Intellectual Property Offices in
several stages over the term of the patent. Maintenance fees are also due for pending patent applications in some countries. The USPTO
and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar
provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by
other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of
the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events
that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to office
actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event,
our competitors might be able to enter the market, which would have a material adverse effect on our business.

 The life of patent protection is limited,
and third parties could develop and commercialize methods, products, and technologies similar or identical to ours and compete directly
with us after the patent licensed to us expires, which could materially and adversely affect our ability to commercialize our product
and technologies.

 The life of a patent and the protection it affords
is limited. For example, in the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20 years from its earliest U.S. non-provisional filing date. In Europe, the expiration of an invention patent is 20 years from its filing
date. Even if we successfully obtain patent protection for a diagnostic method and/or an approved vaccine candidate, it may face competition,
e.g., from biosimilar medications. Diagnostic companies or manufacturers of biosimilar drugs may challenge the scope, validity or enforceability
of the patents underlying our technology in court or before a patent office, and the patent holder may not be successful in enforcing
or defending those intellectual property rights and, as a result, we may not be able to develop or market the relevant method/product
candidate exclusively, which would materially adversely affect any potential sales of that product.

 Given the amount of time required for the development,
testing and regulatory review of new diagnostic methods and/or vaccine candidates, patents protecting such diagnostic methods and/or vaccine
candidates might expire before or shortly after such methods or vaccine candidates are commercialized. As a result, the patents and patent
applications owned or licensed to us may not provide us with sufficient rights to exclude others from commercializing methods/products
similar or identical to ours. Even if we believe that the patents involved are eligible for certain (and time-limited) patent term extensions,
there can be no assurance that the applicable authorities, including the FDA and the USPTO, and any equivalent regulatory authority in
other countries, will agree with our assessment of whether such extensions are available, and such authorities may refuse to grant extensions
to such patents, or may grant more limited extensions than requested. For example, depending upon the timing, duration and specifics of
any FDA marketing approval of any product candidates we may develop, one or more of the U.S. patents licensed to us may be eligible for
limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.
The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory
review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product
approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing
it may be extended. However, we may not be granted an extension because of, for example, failing to exercise due diligence during the
testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant
patents, or otherwise failing to satisfy applicable requirements.

 Moreover, the applicable time period or the scope
of patent protection afforded could be less than requested. If we are unable to obtain patent term extension or term of any such extension
is less than requested, our competitors may obtain approval of competing products following our patent expiration, and our business could
be harmed. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish
the value of our patents or narrow the scope of our patent protection.

 The patents and pending patent applications licensed
to us for our diagnostic methods and product candidates are expected to expire on various dates. Upon the expiration, we will not be able
to assert such licensed patent rights against potential competitors, which would materially adversely affect our business, financial condition,
results of operations and prospects.

 We may need to license intellectual property
from third parties, and such licenses may not be available or may not be available on commercially reasonable terms or at all.

 There may be intellectual property rights existing
now, or in the future, relevant to our methods and/or product and/or product candidates that we seek to commercialize or develop, if any,
that may affect our ability to commercialize such methods and/or product and/or product candidates. Although the Company is not aware
of any such intellectual property rights, a third-party may hold intellectual property rights, including patent rights, that are important
or necessary to the development or manufacture of our methods and/or product and/or product candidates. Even if all our main methods and/or
product and/or product candidates are covered by patents, it may be necessary for us to use the patented or proprietary technology of
third parties to commercialize our methods and/or product and/or product candidates, in which case we would be required to obtain a license
from these third parties. Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept
unfavorable contractual terms. In that event, we may be required to expend significant time and resources to redesign our technology,
methods and/or product and/or product candidates, or the methods for manufacturing them or to develop or license replacement technology,
all of which may not be feasible on a technical or commercial basis. If we are unable to do so, our business could be harmed.

 The licensing or acquisition of third-party intellectual
property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third party
intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage
over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies
that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third
party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable
to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights
we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on
our business, financial condition, results of operations and prospects.

 We may infringe the intellectual property
rights of others, which may prevent or delay our method and/or product development efforts and stop us from commercializing or increase
the costs of commercializing our methods and/or product and/or product candidates.

 Our success will depend in part on our ability
to operate without infringing the proprietary rights of third parties. We are not aware of any third-party proprietary rights that our
planned methods and/or product will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the
earliest stages of development. We thus cannot guarantee that our methods and/or product and/or product candidates, or manufacture or
use of our product and/or product candidates, will not infringe third-party patents. Furthermore, a third party may claim that we are
using inventions covered by the third party's patent rights and may go to court to stop us from engaging in our normal operations
and activities, including making or selling our methods and/or product and/or product candidates. These lawsuits are costly and could
affect our results of operations and divert the attention of managerial and scientific personnel. Some of these third parties may be better
capitalized and have more resources than us. There is a risk that a court would decide that we are infringing the third party's
patents and would order us to stop the activities covered by the patents. In that event, we may not have a viable way around the patent
and may need to halt commercialization of our methods and/or product and/or product candidates. In addition, there is a risk that a court
will order us to pay the other party damages for having violated the other party's patents. In addition, we may be obligated to
indemnify our licensors and collaborators against certain intellectual property infringement claims brought by third parties, which could
require us to expend additional resources. The diagnostic, pharmaceutical and biotechnology industries have produced a proliferation of
patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of
use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.

 If we are sued for patent infringement, we would
need to demonstrate that our product and/or product candidates or methods either do not infringe the patent claims of the relevant patent
or that the patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving
invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even
if we are successful in these proceedings, we may incur substantial costs and diversion of management's time and attention in pursuing
these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others,
we may be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents
in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful
conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action
successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing
our methods and/or product and/or product candidates to market and be precluded from manufacturing or selling our product and/or product
candidates.

 Some of our competitors may be able to sustain
the costs of complex patent litigation more effectively than us or the third parties from whom we license intellectual property because
they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation
could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

 We may become involved in lawsuits to protect
or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.

 In addition to the possibility of litigation relating
to infringement claims asserted against it, we may become a party to other patent litigation and other proceedings, including inter
partes review proceedings, post-grant review proceedings, derivation proceedings declared by the USPTO and similar proceedings in
foreign countries, regarding intellectual property rights with respect to our current or future technologies or methods and/or product
and/or product candidates. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial.
Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their
substantially greater financial resources. Patent litigation and other proceedings may also absorb significant management time. Uncertainties
resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace.

 Competitors may infringe or otherwise violate
our intellectual property, including patents that may be issued to or be licensed by us. As a result, we may be required to file claims
in an effort to stop third-party infringement or unauthorized use. Any such claims could provoke these parties to assert counterclaims
against us, including claims alleging that we infringe their patents or other intellectual property rights, and/or that any of our intellectual
property, including licensed intellectual property, is invalid and/or unenforceable. This can be prohibitively expensive, particularly
for a company of our size, and time-consuming, and even if we are successful, any award of monetary damages or other remedy we may receive
may not be commercially valuable. In addition, in an infringement proceeding, a court may decide that our asserted intellectual property
is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our intellectual
property does not cover its technology. An adverse determination in any litigation or defense proceedings could put our intellectual property
at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not being issued.

 If the breadth or strength of our patent or other
intellectual property rights is compromised or threatened, it could allow third parties to exploit and, in particular, commercialize our
technology or methods and/or product or result in our inability to exploit and/or commercialize our technology and methods and/or product
without infringing third-party intellectual property rights. Further, third parties may be dissuaded from collaborating with us.

 Interference or derivation proceedings brought
by the USPTO, or its foreign counterparts may be necessary to determine the priority of inventions with respect to our patent applications,
and we may also become involved in other proceedings, such as re-examination proceedings, before the USPTO or its foreign counterparts.
Due to the substantial competition in the pharmaceutical space, the number of such proceedings may increase. This could delay the prosecution
of our pending patent applications or impact the validity and enforceability of any future patents that we may obtain. In addition, any
such litigation, submission or proceeding may be resolved adversely to us and, even if successful, may result in substantial costs and
distraction to our management.

 If we are not able to adequately prevent
disclosure of trade secrets and other proprietary information, the value of our technology and product could be significantly diminished.

 We also rely on trade secrets to protect our proprietary
technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult
to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored
researchers, and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent
disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential
information. In addition, others may independently discover our trade secrets and proprietary information. For example, the FDA, as part
of its transparency initiative, is currently considering whether to make additional information publicly available on a routine basis,
including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time
how the FDA's disclosure policies may change in the future, if at all. Costly and time-consuming litigation could be necessary to
enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect
our competitive business position.

 We may be subject to claims that our employees
or consultants have wrongfully used or disclosed alleged trade secrets.

 As is common in the biotechnology and pharmaceutical
industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors
or potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how
of others in their work for us, we may be subject to claims that we or our employees or consultants have inadvertently or otherwise used
or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these
claims. If we fail to defend any such claims, in addition to paying monetary damages, we could lose valuable intellectual property rights
or personnel, which could adversely impact our business. Even if we are successful in defending against these claims, litigation could
result in substantial costs and be a distraction to management.

 Our intellectual property may not be sufficient
to protect our methods and/or product and/or product candidates from competition, which may negatively affect our business as well as
limit our partnership or acquisition appeal.

 We may be subject to competition despite the existence
of intellectual property we license or own or may in the future own. We can give no assurances that our intellectual property claims will
be sufficient to prevent third parties from designing around patents we own or license and developing and commercializing competitive
products. The existence of competitive products that avoid our intellectual property could materially adversely affect our operating results
and financial condition. Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest of third
parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable risk to commercialization
of our methods and/or product and/or product candidates or future product and/or product candidates.

 We may elect to sue a third party, or otherwise
make a claim, alleging infringement or other violation of patents, trademarks, trade dress, copyrights, trade secrets, domain names or
other intellectual property rights that we either own or license from a third party. If we do not prevail in enforcing our intellectual
property rights in this type of litigation, we may be subject to:

 paying monetary damages related to the legal expenses of the third party;

 facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product; and

 restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.

 A third party may also challenge the validity,
enforceability, or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the
scope or claims of or invalidate patents that are integral to our product and/or product candidates in the future. There can be no assurance
that we will be able to successfully defend patents we own or license in an action against third parties due to the unpredictability of
litigation and the high costs associated with intellectual property litigation, amongst other factors.

 Intellectual property rights may be less extensive
and enforcement more difficult in jurisdictions outside of the U.S. Therefore, we may not be able to protect our intellectual property
and third parties may be able to market competitive products that may use some or all of our intellectual property.

 Intellectual property rights do not necessarily
address all potential threats to our competitive advantage and changes in patent laws or patent jurisprudence could diminish the value
of patents in general, thereby impairing our ability to protect our product.

 The America Invents Act ("AIA") has
been enacted in the United States, resulting in significant changes to the U.S. patent system. An important change introduced by the AIA
is that, as of March 16, 2013, the United States transitioned to a "first-to-file" system for deciding which party should
be granted a patent when two or more patent applications are filed by different parties claiming the same invention. A third party that
files a patent application in the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours
even if we had made the invention before it was made by the third party. This will require us to be cognizant going forward of the time
from invention to filing of a patent application, but circumstances could prevent us from promptly filing patent applications on our inventions.

 Among some of the other changes introduced by
the AIA are changes that limit where a patentee may file a patent infringement suit and provide opportunities for third parties to challenge
any issued patent in the USPTO. This applies to all of our U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary
standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third
party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence
would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to
use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as
a defendant in a district court action. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution
of our patent applications and the enforcement or defense of our issued patents.

 Additionally, the U.S. Supreme Court has ruled
on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening
the rights of patent owners in certain situations. This is in particular the case in the field of diagnostic patents based on biomarkers
(Mayo v. Prometheus, 566 U.S. 66 (2012)), where Proteomedix is active. In addition to increasing uncertainty with regard to our ability
to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
Depending on decisions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change
in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that we might
obtain in the future.

 Any inability of us to protect our competitive
advantage with regard to any of our product candidates may prevent us from successfully monetizing such product candidate and this could
materially adversely affect our business, prospects, financial condition and results of operations.

 Risks Related to Healthcare Compliance and
Other Regulations

 If we fail to comply with healthcare regulations,
we could face substantial enforcement actions, including administrative, civil, and criminal penalties and our business, operations and
financial condition could be adversely affected.

 We could be subject to healthcare fraud and abuse
laws and health information privacy and security laws of both the federal government and the states in which we conduct our business.
The laws include:

 the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

 Federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which can be enforced by individuals through civil whistleblower and qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.;

 The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by Covered Recipients, as defined at 42 CFR Part 403, Subpart I;

 HIPAA which prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services, and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information and certain notification requirements and criminal and civil penalties for failure to comply with those requirements;

 the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; and

 state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

 If our operations are found to be in violation
of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including administrative,
civil, and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment
or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Although compliance
programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal
expenses and divert management's attention from the operation of our business. Moreover, achieving and sustaining compliance with
applicable federal and state privacy, security and fraud laws may prove costly.

 Healthcare reform in the United States has
been implemented in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare
industry. Violations of healthcare laws can have an adverse impact on our ability to advance our product and our operating results.

 In the United States, there have been, and continue
to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future results
of pharmaceutical manufactures' operations. In particular, there have been and continue to be a number of initiatives at the federal
and state levels that seek to reduce healthcare costs. For example, the Affordable Care Act, or the ACA, which was originally enacted
in March 2010 and subsequently amended, includes measures to significantly change the way healthcare is financed by both governmental
and private insurers.

 In August 2022, President Biden signed the Inflation
Reduction Act, which extended enhanced subsidies, passed as part of the American Rescue Plan Act in 2021, and prevented insurance companies
from imposing significant increases in healthcare premiums for low-income exchange customers through 2025. In addition, under this legislation,
Medicare will have the ability to negotiate drug prices for a select list of pharmaceuticals in Medicare Part D drugs, with the list of
included drugs expected to increase over the coming years and incorporate drugs in Medicare Parts B and D.

 Our employees may engage in misconduct or other
improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us
and harm our reputation.

 We are exposed to the risk of employee fraud or
other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory
authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards
we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established
and enforced by comparable foreign regulatory authorities, report financial information or data accurately or disclose unauthorized activities
to us. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity
may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other
actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against
us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business
and results of operations, including the imposition of significant civil, criminal and administrative penalties, damages, fines, imprisonment,
exclusion from government funded healthcare programs, such as Medicare and Medicaid, and integrity oversight and reporting obligations.

 We may rely on government funding and collaboration
with government entities for our product development, which adds uncertainty to our research and development efforts and may impose requirements
that increase the costs of development, commercialization and production of any programs developed under those government-funded programs.

 Because we anticipate the resources necessary
to develop our product and/or product candidates will be substantial, we may explore funding and development collaboration opportunities
with the U.S. government and its agencies. For example, we may apply for certain grant funding from BARDA, the NIH or other government
agencies to further the research, development, manufacture, testing, and regulatory approval of our product and/or product candidates.
We have no control or input over whether an application for BARDA grant funding or any other funding will be accepted or approved, in
full or in part, and we cannot provide investors with any assurances that we will receive such funding.

 Contracts and grants funded by the U.S. government
and its agencies, contain provisions that reflect the government's substantial rights and remedies, many of which are not typically
found in commercial contracts, including powers of the government to:

 reduce or modify the government's obligations under such agreements without the consent of the other party;

 claim rights, including Intellectual Property rights, in products and data developed under such agreements;

 audit contract-related costs and fees, including allocated indirect costs;

 suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations.

 impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;

 suspend or debar the contractor or grantee from doing future business with the government;

 control and potentially prohibit the export of products;

 pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and

 limit the government's financial liability to amounts appropriated by the U.S. Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.

 If we received such grants or agreements, we may
not have the right to prohibit the U.S. government from using certain technologies developed by us, and we may not be able to prohibit
third parties, including our competitors, from using those technologies in providing products and services to the U.S. government. Further,
under such agreements we could be subject to obligations to and the rights of the U.S. government set forth in the Bayh-Dole Act of 1980,
meaning the U.S. government may have rights in certain inventions developed under these government-funded agreements, including a non-exclusive,
non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government could
have the right to require us to grant exclusive, partially exclusive, or nonexclusive licenses to any of these inventions to a third party
if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet
public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations,
also referred to as "march-in rights." Although the U.S. government's historic restraint with respect to these rights
indicates they are unlikely to be used, any exercise of the march-in rights could harm our competitive position, business, financial condition,
results of operations and prospects. In the event we would be subject to the U.S. government's exercise such march-in rights, we
may receive compensation that is deemed reasonable by the U.S. government in its sole discretion, which may be less than what we might
be able to obtain in the open market.

 Additionally, the U.S. government requires that
any products embodying any invention generated through the use of U.S. government funding be manufactured substantially in the United
States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but
unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially
in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. manufacturers
may limit our ability to contract with non-U.S. manufacturers for products covered by such intellectual property.

 Although we may need to comply with some of these
obligations, not all of the aforementioned obligations may be applicable to us unless and only to the extent that we receive a government
grant, contract or other agreement. However, as an organization, we are relatively new to government contracting and new to the regulatory
compliance obligations that such contracting entails. If we were to fail to maintain compliance with those obligations, we may be subject
to potential liability and to termination of our contracts, which may have a materially adverse effect on our ability to develop our product
and/or product candidates.

 We are subject to U.S. and certain foreign
export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with
these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other
serious consequences for violations, which can harm our business.

 We are subject to export control and import laws
and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions
regulations administered by the U.S. Treasury Department's Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices
Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act
and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption
laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing,
promising, offering or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private
sector. We may engage third parties for clinical trials outside of the United States, to sell our product abroad once we enter a commercialization
phase and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions
with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can
be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we
do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may
result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments,
breach of contract and fraud litigation, reputational harm and other consequences.

 Risks Related to Owning our Common Stock

 The market price of our common stock has
been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could
lose all or part of their investment.

 The market price of our common stock may be highly
volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:

 whether we achieve our anticipated corporate objectives;

 actual or anticipated fluctuations in our financial condition and operating results;

 changes in financial or operational estimates or projections;

 our execution of our sales and marketing, manufacturing and other aspects of our business plan;

 performance of third parties on whom we rely to manufacture our product and product components, including their ability to comply with regulatory requirements;

 results of operations that vary from those of our competitors and the expectations of securities analysts and investors;

 changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors;

 our announcement of significant contracts, acquisitions, or capital commitments;

 announcements by our competitors of competing products or other initiatives;

 announcements by third parties of significant claims or proceedings against us;

 regulatory and reimbursement developments in the United States and abroad;

 future sales of our common stock;

 product liability claims;

 healthcare reform measures in the United States;

 additions or departures of key personnel; and

 general economic or political conditions in the United States or elsewhere.

 In addition, the stock market in general, and
the stock of medical biotechnology companies like ours, in particular, have experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of the issuer. For example, on September 27, 2024 and December 24,
2024, the closing price of our common stock on Nasdaq was $5.96 and $0.34, respectively, and daily trading volume on these days was approximately
872,668 and 506,500 shares, respectively. These broad market fluctuations may adversely affect the trading price of our common stock.
In particular, a proportion of our common stock may be traded by short sellers which may put pressure on the supply and demand for our
common stock, further influencing volatility in its market price. Additionally, these and other external factors have caused and may continue
to cause the market price and demand for our common stock to fluctuate, which may limit or prevent investors from readily selling their
shares of common stock and may otherwise negatively affect the liquidity of our common stock. While the market price of our common stock
may respond to developments regarding operating performance and prospects, expansion plans, developments regarding our participation in
direct contracting, and developments regarding our industry, we believe that the extreme volatility we experienced in recent periods reflects
market and trading dynamics unrelated to our underlying business, our actual or expected operating performance, our financial condition,
or macro or industry fundamentals, and we do not know if these dynamics will continue or how long they will last. Under these circumstances,
we caution you against investing in our common stock, unless you are prepared to incur the risk of losing all or a substantial portion
of your investment.

 We may be subject to securities litigation, which is expensive
and could divert our management's attention.

 The market price of our securities may be volatile,
and in the past, companies that have experienced volatility in the market price of their securities have been subject to securities class
action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial
costs and divert our management's attention from other business concerns, which could seriously harm our business.

 We may have violated Section 13(k) of the
Exchange Act (implementing Section 402 of the Sarbanes-Oxley Act of 2002) and may be subject to sanctions as a result.

 Section 13(k) of the Exchange Act
provides that it is unlawful for a company that has a class of securities registered under Section 12 of the Exchange Act to,
directly or indirectly, including through any subsidiary, extend or maintain credit in the form of a personal loan to or for any of its
directors or executive officers. In the fiscal year ended December 31, 2022 and the nine months ended September 30, 2023,
we paid certain expenses of our former Chief Executive Officer and Chairman of the Board, which may be deemed to be personal loans made
by us to our former Chief Executive Officer and Chairman of the Board that are not permissible under Section 13(k) of the Exchange Act.
Specifically, after a review completed by the Audit Committee, it was determined that our former
CEO and an accounting employee charged certain personal expenses on their corporate credit cards that were not recorded as related party
receivables. The aggregate amount of such unauthorized charges ranged from approximately (i) $257,000 to $405,000 for all of 2022, (ii)
$86,000 to $122,000 for the quarter ended March 31, 2023 and (iii) $79,000 to $150,000 for the quarter ended June 30, 2023. The accounting
employee was also the CEO's assistant and had roles in the Company's system of internal control over financial reporting,
including controls relating to the Company's corporate credit cards. Issuers that are found to have violated Section 13(k) of
the Exchange Act may be subject to civil sanctions, including injunctive remedies and monetary penalties, as well as criminal sanctions.
The imposition of any of such sanctions on us could have a material adverse effect on our business, financial position, results of operations
or cash flows.

 If we fail to maintain
proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. We have
identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated,
or that additional material weaknesses will not occur in the future.

 We are subject to the reporting requirements of
the Exchange Act, the Sarbanes-Oxley Act and Nasdaq rules and regulations. The Sarbanes-Oxley Act requires, among other
things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. Effective internal
control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls
and procedures, is designed to prevent fraud. We must perform system and process evaluation and testing of our internal controls over
financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting in our Annual
Report on Form 10-K for each year, as required by Section 404 of the Sarbanes-Oxley Act ("Section 404").
This requires significant management efforts and requires us to incur substantial professional fees and internal costs to expand our accounting
and finance functions. Any failure to implement required new or improved controls, or difficulties encountered in their implementation,
could cause us to fail to meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection
with Section 404, or any subsequent testing by our independent registered public accounting firm, as and when required, may reveal
deficiencies in our internal controls over financial reporting that are deemed to be significant deficiencies or material weaknesses or
that may require prospective or retroactive changes to our financial statements, or may identify other areas for further attention or
improvement. Furthermore, we cannot be certain that our efforts will be sufficient to remediate or prevent future material weaknesses
or significant deficiencies from occurring.

 We do not yet have effective disclosure controls
and procedures, or internal controls over all aspects of our financial reporting. Specifically, we have identified the following control
deficiencies which we believe are material weaknesses.

 We did not maintain an effective control environment as there was an inadequate segregation of duties with respect to certain cash disbursements.

 We do not have an effective risk assessment process or effective monitoring of compliance with established accounting policies and procedures, and do not demonstrate a sufficient level of precision in the application of our controls.

 Our controls over the approval and reporting of expense payments were not designed and maintained to achieve the Company's objectives.

 We have insufficient accounting resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements.

 The Company did not design, implement, and maintain effective controls to ensure information technology ("IT") policies and procedures set the tone at the top, to mitigate the risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer operations domains. Specifically, the design and implementation of user authentication, user access privileges, data backup and data recovery controls as well as the monitoring controls of excessive user access and elevated privileged access to financial applications and data were not appropriately designed and maintained. In addition, these inadequate ITGC controls combined with the use of personal devices to conduct business, can lead to an IT control environment vulnerable to breaches and social engineering persuasion.

 We cannot provide assurances
that these weaknesses will be effectively remediated, or that additional material weaknesses will not occur in the future.

 As a result of the material
weaknesses in our internal controls over financial reporting described above, and other matters raised or that may in the future be raised
by the SEC, we may face for the prospect of litigation or other disputes which may include, among others, claims invoking the federal
and state securities laws, contractual claims or other claims arising from the material weaknesses in our internal control over financial
reporting and the preparation of our financial statements, any of which claims could result in adverse effects to our business. As of
the date hereof, we have no knowledge of any such litigation or dispute.

 Our Amended and Restated Certificate of
Incorporation requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors,
officers, other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery
in the State of Delaware and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service
of process on such stockholder's counsel, which may have the effect of discouraging lawsuits against our directors, officers, other
employees or stockholders.

 Our Amended and Restated Certificate of Incorporation
requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers,
other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in
the State of Delaware and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service
of process on such stockholder's counsel except any action (A) as to which the Court of Chancery in the State of Delaware determines
that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent
to the personal jurisdiction of the Court of Chancery within ten days following such determination), (B) which is vested in the exclusive
jurisdiction of a court or forum other than the Court of Chancery, (C) for which the Court of Chancery does not have subject matter jurisdiction,
or (D) any action arising under the Securities Act, as to which the Court of Chancery and the federal district court for the District
of Delaware shall have concurrent jurisdiction. Any person or entity purchasing or otherwise acquiring any interest in shares of our capital
stock shall be deemed to have notice of and consented to the forum provisions in our Amended and Restated Certificate of Incorporation.
This choice of forum provision may make it more costly for a stockholder to bring a claim, and it may also limit a stockholder's
ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees
or stockholders, which may discourage lawsuits with respect to such claims, although our stockholders cannot waive our compliance with
federal securities laws and the rules and regulations thereunder. Alternatively, if a court were to find the choice of forum provision
contained in our Amended and Restated Certificate of Incorporation to be inapplicable or unenforceable in an action, we may incur additional
costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.

 Our Amended and Restated Certificate of Incorporation
provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable law. Section 27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the
rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability
created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. In addition, our Amended and
Restated Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative forum, the federal
district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum for the resolution
of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, or the rules and regulations promulgated
thereunder. We note, however, that there is uncertainty as to whether a court would enforce this provision and that investors cannot waive
compliance with the federal securities laws and the rules and regulations thereunder. Section 22 of the Securities Act creates concurrent
jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the Securities Act or the
rules and regulations thereunder.

 An active trading market for our common
stock may not develop or be sustained.

 Although our common stock is listed on The Nasdaq
Capital Market, an active trading market for our common stock may not develop, or if developed, be sustained. The lack of an active market
may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of
an active market may also reduce the fair value of your shares.

 Further, an inactive market may also impair our
ability to raise capital by selling shares of our common stock may impair our ability to enter into strategic partnerships or acquire
companies or products by using our shares of common stock as consideration.

 Our principal stockholders and management
own a significant percentage of our capital stock and will be able to exert a controlling influence over our business affairs and matters
submitted to stockholders for approval.

 As of May 30, 2025, our officers and directors,
together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 2,695,931
shares of our common stock, which in the aggregate represents approximately 6.08% of the outstanding shares of our common stock. As a
result, if some of these persons or entities act together, they will have the ability to exercise significant influence over matters submitted
to our stockholders for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate
of Incorporation and Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.
These actions may be taken even if they are opposed by other stockholders. This concentration of ownership may also have the effect of
delaying or preventing a change of control of our company or discouraging others from making tender offers for our shares, which could
prevent our stockholders from receiving a premium for their shares. Some of these persons or entities who make up our principal stockholders
may have interests different from yours.

 There can be no assurance that we will be
able to comply with the continued listing standards of Nasdaq.

 Our continued eligibility for listing on Nasdaq
depends on our ability to comply with Nasdaq's continued listing requirements.

 On January 24, 2025, the Company received a letter
from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of the Company's Common Stock
from November 25, 2024 to January 10, 2025, the Company is no longer in compliance with the requirement for continued listing on The Nasdaq
Capital Market to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the "Minimum
Bid Price Rule"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq provided the Company with 180 calendar days to regain
compliance with the Minimum Bid Price Rule.

 On April 14, 2025, Nasdaq issued a further notice
to the Company that it determined that the Company's securities had a closing bid price of $0.10 or less for ten consecutive trading
days. Accordingly, the Company is subject to the provisions under Nasdaq Listing Rule 5810(c)(3)(A)(iii). As a result, unless the Company
timely requested a hearing before the Nasdaq Hearings Panel (the "Panel"), trading of the Common Stock would be suspended
at the opening of business on April 23, 2025, and a Form 25-NSE would be filed with the SEC, which would remove the Company's securities
from listing and registration on Nasdaq. On May 27, 2025, the Company appeared before the Nasdaq Hearings Panel and requested a stay of
suspension. The Panel's decision about the stay request is still pending as of the date these financials were filed.

 On April 24, 2025, the Company received an additional
deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq's continued listing standards as set forth in Listing
Rule 5250(c)(1) given the Company's failure to timely file its Annual Report on Form 10-K for the fiscal year ended December 31,
2024, and that this matter serves as an additional basis for delisting the Company's securities from Nasdaq. As the Company was
already before a Panel for its failure to comply with Minimum Bid Price Rule, the Company had seven calendar days from the date of the
Notice, or until May 1, 2025, to request a stay of the suspension, which request would stay the suspension of the Company's securities
pending the Panel's decision. The Company submitted a stay request on or before May 1, 2025.

 On May 20, 2025, the Company received an additional
deficiency notice from Nasdaq that the Company was not in compliance with Nasdaq's continued listing standards as set forth in Listing
Rule 5250(c)(1) given the Company's failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025,
and that this matter serves as an additional basis for delisting the Company's securities from Nasdaq. The Company had seven calendar
days from the date of the Notice, or until May 27, 2025, to request a stay of the suspension, which would stay the suspension of the Company's
securities pending the Panel's decision. On May 27, 2025, the Company appeared before the Nasdaq Hearings Panel and requested a
stay of suspension. The Panel's decision about the stay request is still pending as of the date these financials were filed.

 There are no assurances that the Panel will grant
the Company's request for continued listing or an extension to demonstrate compliance. If the Company does not obtain a favorable
decision from the Panel, its Common Stock will become subject to delisting.

 If Nasdaq delists our common stock from trading
on its exchange for failure to meet the Bid Price Rule or any other listing standards, we and our stockholders could face significant
material adverse consequences including:

 a limited availability of market quotations for our securities;

 a determination that our common stock is a "penny stock," which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;

 a limited amount of analyst coverage; and

 a decreased ability to issue additional securities or obtain additional financing in the future.

 If our shares become subject to the penny stock rules, it would
become more difficult to trade our shares.

 The SEC has adopted rules that regulate broker-dealer
practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00,
other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems,
provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system.
If we do not retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny
stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to
deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before
effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination
that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser's written acknowledgment of the receipt
of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of
a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market
for our common stock, and therefore stockholders may have difficulty selling their shares.

 Future sales of our shares by existing stockholders could cause
our stock price to decline.

 If
 we or our existing stockholders, directors and officers sell, or indicate an intent to sell,
 substantial amounts of our common stock or securities convertible into our common stock in
 the public market after contractual lock-up and other legal restrictions on resale lapse,
 the trading price of our common stock could decline significantly and could decline below
 the initial public offering price. We have outstanding 44,358,422 shares of common stock
 as of the date hereof, assuming no exercise of outstanding options or warrants, are or will
 be freely tradable, without restriction, in the public market. If our existing stockholders
 sell substantial amounts of our common stock in the public market, or if the public perceives
 that such sales could occur, this could have an adverse impact on the market price of our
 common stock, even if there is no relationship between such sales and the performance of
 our business. We have previously registered 1,450,000 shares of common stock under our equity
 compensation plans. These shares can be freely sold in the public market upon issuance, subject
 to volume limitations applicable to affiliates and lock-up agreements.

 Upon issuance, the 13,674 shares subject to outstanding
options under our stock option plan and the shares reserved for future issuance under our stock option plan will become eligible for
sale in the public market in the future, subject to certain legal and contractual limitations. If our existing stockholders sell substantial
amounts of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse
impact on the market price of our common stock, even if there is no relationship between such sales and the performance of our business.

 The issuance or conversion of securities would result in significant
dilution in the equity interest of existing shareholders and adversely affect the market price of the securities.

 The issuance or conversion of common shares or other securities convertible
into common shares would result significant dilution in the equity interest of existing shareholders and adversely affect the market price
of the common shares.

 In particular, the Company is party to an ELOC,
pursuant to which it may offer and sell, from time to time at its sole discretion, up to $25.0 million of newly issued Common Stock, subject
to certain limitations. As of December 31, 2024 and May 30, 2025, the Company has sold approximately 2,757,933 shares and 33,256,563 shares
under the ELOC Purchase Agreement for aggregate proceeds of approximately $0.9 million and $5.3 million, respectively, totaling 36,014,496
shares sold under the ELOC Purchase Agreement for gross proceeds of approximately $6.2 million. In January 2025, there were 3,492,067
shares that were settled bringing the total sold shares to approximately 6,250,000 shares under the ELOC Purchase Agreement. Additionally,
as of May 30, 2025, an aggregate of 2,130 Series C Preferred Stock was outstanding, after redemptions of 1,369 shares for an aggregate
of $1.71 million. An additional amount of $150,531 is due to the PIPE Series C investors for 120 Series C preferred shares that remain
due from the most recent ELOC draw. These 120 shares remain subject to future redemption.

 If we fail to maintain an effective system
of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory
sanctions, harm our business and operating results and cause the trading price of our stock to decline.

 Effective internal controls required under Section
404 of the Sarbanes-Oxley Act are necessary for us to provide reliable financial reports and effectively prevent fraud. If we cannot provide
reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed. We have discovered, and may
in the future discover, areas of our internal controls that need improvement. We cannot be certain that the measures we have taken or
intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future. Any failure to
implement the required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions,
harm our business and operating results or cause us to fail to meet our reporting obligations. Inferior internal controls could also harm
our reputation and cause investors to lose confidence in our reported financial information, which could have a negative impact on the
trading price of our stock.

 We are an "emerging growth company"
and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

 We are an "emerging growth company,"
as defined in the JOBS Act. We may remain an "emerging growth company" until as late as December 31, 2027 (the fiscal year-end
following the fifth anniversary of the completion of our initial public offering, which closed during February 2022), though we may cease
to be an "emerging growth company" earlier under certain circumstances, including (1) if the market value of our common stock
that is held by nonaffiliates exceeds $700 million as of any June 30, in which case we would cease to be an "emerging growth company"
as of the following December 31, or (2) if our gross revenue exceeds $1.235 billion in any fiscal year. "Emerging growth companies"
may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies, including
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations
regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding
advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Investors could
find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

 In addition, Section 102 of the JOBS Act also
provides that an "emerging growth company" can take advantage of the extended transition period provided in Section 7(a)(2)(B)
of the Securities Act, for complying with new or revised accounting standards. An "emerging growth company" can therefore
delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

 We are subject to increased costs as a result
of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.

 As a public company, we incur significant legal, accounting, and other
expenses that we did not incur as a private company, including costs associated with public company reporting requirements. The Sarbanes-Oxley
Act of 2002, as amended, or Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The Nasdaq Capital Market to implement
provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance
of effective disclosure and financial controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall
Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are significant corporate governance and executive
compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas, such
as "say on pay" and proxy access. Emerging growth companies may implement many of these requirements over a longer period
of up to five years from the pricing of their initial public offering. We intend to take advantage of these extended transition periods
but cannot guarantee that we will not be required to implement these requirements sooner than budgeted or planned and thereby incur unexpected
expenses. Stockholder activism, the current political environment and the current high level of government intervention and regulatory
reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the
manner in which we operate our business in ways we cannot currently anticipate. Our management and other personnel will devote a substantial
amount of time to these compliance programs and monitoring of public company reporting obligations and as a result of the new corporate
governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act and further regulations
and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply with such compliance
programs and rules. These rules and regulations will cause us to incur significant legal and financial compliance costs and will make
some activities more time-consuming and costly.

 To comply with the requirements of being a public
company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting
or internal audit staff. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control
over financial reporting. We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure
that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported
within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Securities
Exchange Act of 1934, as amended, or the Exchange Act, is accumulated and communicated to our principal executive and financial officers.
Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial
reporting may be discovered in the future. Any failure to develop or maintain effective controls when we become subject to this requirement
could negatively impact the results of periodic management evaluations and annual independent registered public accounting firm attestation
reports regarding the effectiveness of our internal control over financial reporting that we may be required to include in our periodic
reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, harm our operating results,
cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial statements. In the event that
we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived
as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating
results and the price of our common stock could decline. In addition, if we are unable to continue to meet these requirements, we may
not be able to remain listed on Nasdaq.

 The rules and regulations applicable to public
companies have substantially increased our legal and financial compliance costs and make some activities more time-consuming and costly.
If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse
effect on our business, financial condition, and results of operations. The increased costs will decrease our net income and may require
us to reduce costs in other areas of our business or increase the prices of our product or services. For example, these rules and regulations
made it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial
costs in the future to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we
may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain
qualified persons to serve on our board of directors, our board committees or as executive officers.

 Our management team has limited experience
managing a public company.

 Several members of our management team have limited
experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly complex laws
pertaining to public companies. Our management team may not successfully or efficiently manage our transition to being a public company
subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of
securities analysts and investors. These new obligations and constituents require significant attention from our senior management and
could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial
condition and operating results.

 If securities or industry analysts do not
publish research, or publish inaccurate or unfavorable research, about our business, our stock price and our trading volume could decline.

 The trading market for our common stock depends,
in part, on the research and reports that securities or industry analysts publish about us or our business. While we currently have certain
analyst coverage, if one or more of the analysts who cover us downgrade our common stock or publish inaccurate or unfavorable research
about our business, our stock price could decline. In addition, if our operating results fail to meet the forecast of analysts, our stock
price could decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our
common stock could decrease, which might cause our stock price and trading volume to decline.

 Failure in, or security breaches or incidents
impacting, our information technology or storage systems could significantly disrupt our operations and our research and development efforts.

 Our ability to execute our business strategy will
depend, in part, on the continued and uninterrupted performance of our information technology, or IT, systems, which support our operations,
including at our proposed clinical laboratories. We are dependent on our IT systems for many aspects of our business, including our needs
to retain and store our confidential and proprietary business information and to receive and process test orders, securely store patient
health records and deliver the results of our tests. The integrity and protection of our own data, and that of our customers and employees,
is critical to our business. The regulatory environment governing information, security and privacy and data protection laws is increasingly
demanding and continues to evolve. IT systems are vulnerable to damage from a variety of sources, including telecommunications or network
failures, cyberattacks (including ransomware attacks) and other malicious human acts from criminal hackers, hacktivists, state-sponsored
intrusions and other attacks, industrial espionage and employee malfeasance, breaches and incidents due to employee error or negligence,
and natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical
or electronic break-ins, computer viruses and other malicious code or similar disruptive problems.

 Proclarix is comprised of two components: Proclarix
Assays and Proclarix Risk Calculator. The Proclarix Risk Calculator is cloud-based software to integrate the results from Proclarix Assays
for THBS1 and CTSD together with age, total and free PSA (from third party manufacturers) to calculate the Proclarix Risk Score. When
entering the Patient ID, a warning indicates that the Patient ID shall not contain any sensitive personal patient data. After the risk
report is generated, the patient data including values for THBS1, CTSD, total and free PSA together with age and Patient ID is stored
for six months and is then automatically deleted.

 High-profile security breaches and incidents at
other companies and in government agencies have increased in recent years, particularly in the healthcare sector, and security industry
experts and government officials have warned about the risks of hackers and cyber-attacks targeting businesses such as ours. Cyber-attacks
are becoming more sophisticated and frequent, and in some cases have caused significant harm. Computer hackers and others routinely attempt
to breach the security of technology products, services, and systems, and to fraudulently induce employees, customers, or others to disclose
information or unwittingly provide access to systems or data. Much of our workforce currently works remotely rather than in our offices,
and we may be more susceptible to security breaches and incidents as a result. Our service providers also may accommodate remote workers
and therefore may be more susceptible to security breaches and other security incidents.

 We have experienced and may in the future experience
attempted or successful cyber-attacks of our IT systems or networks. To date, we have not experienced any material cyber-attacks. However,
any security breach or incident or interruption could compromise our networks and the information stored therein, including algorithms
relating to our product, could be accessed by unauthorized parties, publicly disclosed, lost, rendered inaccessible or unavailable, corrupted,
or stolen. Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, unauthorized
access to our systems, or disruptions or other security breaches impacting our IT systems, any unauthorized access to, or, loss, inaccessibility,
unavailability, corruption, theft, or disclosure could also disrupt our operations, including our ability to:

 process tests, provide test results, bill patients;

 provide customer assistance services;

 collect, process and prepare company financial information;

 provide information about our tests and other patient and healthcare provider education and outreach efforts through our website; and

 manage the administrative aspects of our business and damage our reputation.

 Any such breach, incident, or other compromise
of IT systems or data, or the perception that any of these has occurred, could result in liability under laws that protect the privacy
of personal information, such as the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information
Technology for Economic and Clinical Health Act of 2009 (collectively, "HIPAA"), similar U.S. state data privacy and security
laws and regulations, and other regulations, as well as in legal claims, complaints, regulatory investigations or proceedings, significant
fines or other penalties, or the requirement to enter into a multi-year settlement and remediation agreement with federal or state agencies.
We also may be required to incur significant costs in an effort to prevent, detect, and remediate security breaches and other security-related
incidents. Additionally, information obtained by third parties in connection with past or future cyberattacks, or other security breaches
or incidents could be used in ways that adversely affect our company or our stockholders.

 Further, third-party service providers who support
our operations, and our independent contractors, consultants, collaborators, and service providers also may suffer interruptions and disruptions
of systems and other breaches, incidents, or other compromises of their IT systems or data that they process or maintain for us, which
may lead to any of the foregoing. We and our third-party service providers may not have the resources or technical sophistication to anticipate
or prevent all cyberattacks or other sources of security breaches or incidents, and we or they may face difficulties or delays in identifying
and responding to cyberattacks and data security breaches and incidents. In addition, the interpretation and application of consumer or
health related data security, privacy and protection laws in the United States, Europe and elsewhere are often uncertain, contradictory
and in flux, such as in the area of international transfers of personal data. Complying with these various laws and satisfying healthcare
providers' and patients' evolving expectations with respect to data protection, could cause us to incur substantial costs
or require us to change our business practices and compliance procedures in a manner adverse to our business.

 We do not maintain insurance policies for cybersecurity-related
matters, data handling or data security liabilities. The successful assertion of one or more large claims against us could have a material
adverse effect on our business, including our financial condition, operating results, and reputation.

 Our Amended and Restated Certificate of
Incorporation and our Amended and Restated Bylaws and Delaware law may have anti-takeover effects that could discourage, delay or prevent
a change in control, which may cause our stock price to decline.

 Our Amended and Restated Certificate of Incorporation
and our Amended and Restated Bylaws and Delaware law could make it more difficult for a third party to acquire us, even if closing such
a transaction would be beneficial to our stockholders. Our Amended and Restated Certificate of Incorporation authorizes us to issue up
to 10 million shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined
at the time of issuance by our board of directors without further action by stockholders. The terms of any series of preferred stock may
include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion
and redemption rights and sinking fund provisions. The issuance of any preferred stock could materially adversely affect the rights of
the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future
holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve
control by the present management.

 Provisions of our Amended and Restated Certificate
of Incorporation, our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals
or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such
provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, our Amended
and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:

 provide the board of directors with the ability to alter the bylaws without stockholder approval;

 place limitations on the removal of directors;

 establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and

 provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

 These provisions, alone or together, could delay
or prevent hostile takeovers and changes in control or changes in our management.

 As a Delaware corporation, we are also subject
to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which prevents certain stockholders holding
more than 15% of our outstanding capital stock from engaging in certain business combinations without approval of the holders of at least
two-thirds of our outstanding common stock not held by such stockholder.

 Any provision of our Amended and Restated Certificate
of Incorporation, Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing, or deterring a change in control
could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the
price that some investors are willing to pay for our common stock.

 We do not anticipate paying any cash dividends
on our common stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source
of gain for the foreseeable future.

 We have never declared or paid cash dividends
on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend
to retain all available funds and any future earnings to fund the development and growth of our business. In addition, any future loan
arrangements we enter into may contain terms prohibiting or limiting the amount of dividends that may be declared or paid on our common
stock. As a result, capital appreciation, if any, of our common stock, which may never occur, will be your sole source of gain for the
foreseeable future.

 A possible "short squeeze" due
to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.

 Investors may purchase our common stock to hedge
existing exposure in our common stock or to speculate on the price of our common stock. Speculation on the price of our common stock may
involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for
purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders
of our common stock. Those repurchases may in turn dramatically increase the price of our common stock until investors with short exposure
are able to purchase additional common shares to cover their short position. This is often referred to as a "short squeeze."
A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance, or prospects
of our company and once investors purchase the shares of common stock necessary to cover their short position the price of our common
stock may decline.

 Risks Related to Pending Business Combination

 If completed, the Ocuvex Business Combination may not achieve
its intended results and may result in us assuming unanticipated liabilities.

 We entered into the Ocuvex LOI with the expectation
that the Ocuvex Business Combination would result in various benefits and growth opportunities. Achieving the anticipated benefits of
the transaction is subject to a large number of risks and uncertainties, including our ability to raise the substantial capital required
for the Ocuvex Business Combination. Additionally, the success of the Ocuvex Business Combination depends on, among other things, the
accuracy of our assessment of the assets associated with the acquired assets, operating costs and various other factors. These assessments
are necessarily inexact. As a result, we may not recover the purchase price for the acquisition or recognize an acceptable return on sales.

 The transactions contemplated by the Ocuvex
LOI are subject to conditions that may not be satisfied on a timely basis or at all. Failure to complete the transactions contemplated
by the Ocuvex LOI could have material and adverse effects on us.

 Completion of the Ocuvex Business Combination
is subject to a number of conditions, including the accuracy of the parties' representations in the transactions as contemplated
by the Ocuvex LOI. Such conditions, some of which are beyond our control, may not be satisfied or waived in a timely manner or at all
and therefore make the completion and timing of the completion of the Ocuvex Business Combination uncertain. In addition, the Ocuvex LOI
contains certain termination rights for both parties, which if exercised will also result in the Ocuvex Business Combination not being
consummated.

 If the transactions contemplated by the Ocuvex
LOI are not completed, our business may be adversely affected and, without realizing any of the benefits of having completed the Ocuvex
Business Combination, we will be required to pay our costs relating to the Ocuvex Business Combination, such as legal, accounting, and
financial advisory fees. In addition, time and resources committed by our management to matters relating to the Ocuvex Business Combination
could otherwise have been devoted to pursuing other beneficial opportunities; and the market price of our common stock could be impacted
to the extent that the current market price reflects a market assumption that the Ocuvex Business Combination will be completed.

 We will be subject to business uncertainties
while the Ocuvex Business Combination is pending, which could adversely affect our business.

 It is possible that certain persons with whom
we have a business relationship may delay certain business decisions relating to us, or seek to terminate, change or renegotiate their
relationships with us, in connection with the pendency of the Ocuvex Business Combination. This could negatively affect our revenues,
earnings and cash flows, as well as the market price of our common stock, regardless of whether the Ocuvex Business Combination is completed.

 We expect to incur significant transaction
costs in connection with the Ocuvex Business Combination.

 We expect to incur a number of non-recurring costs
associated with negotiating and completing the Ocuvex Business Combination. These fees and costs have been, and will continue to be, substantial
and, in many cases, will be borne by us whether or not the Ocuvex Business Combination is completed. A substantial majority of our non-recurring
expenses will consist of transaction costs related to the Ocuvex Business Combination and include, among others, fees paid to financial,
legal, accounting and other advisors. We will continue to assess the magnitude of these costs, and we may incur additional unanticipated
costs. The costs described above and any unanticipated costs and expenses, many of which will be borne by us even if the Ocuvex Business
Combination is not completed, could have an adverse effect on our financial condition and operating results.

 Item 1B. Unresolved Staff Comments.

 None.

 Item 1C. Cybersecurity.

 Cybersecurity Risk Management and Strategy

 We, like other companies in our industry, face
several cybersecurity risks in connection with our business. Our business strategy, results of operations, and financial condition have
not, to date, been materially affected by risks from cybersecurity threats. During the reporting period, we have not experienced any material
cyber incidents, nor have we experienced a series of immaterial incidents, which would require disclosure.

 We are in the process of implementing our cybersecurity
program, which is aimed at safeguarding the confidentiality, integrity, and availability of our essential systems and information, and
is designed to detect and mitigate risks from cybersecurity threats to our data and our systems. Central to our cybersecurity efforts
is a robust incident response plan designed to address potential cyber incidents swiftly and effectively.

 In designing and evaluating our cybersecurity
program, we have adopted the National Institute of Standards and Technology Cybersecurity Framework ("NIST CSF 2.0") as a
guiding principle. It is important to clarify that our use of the NIST CSF 2.0 is for guidance purposes to frame our risk identification,
assessment, and management processes and does not equate to compliance with any specific technical standards or requirements.

 The key components of our cybersecurity program
will include:

 conducting risk assessments to pinpoint material cybersecurity threats to our critical systems, data, product, services, and overall IT infrastructure;

 a third-party security expert consultant overseeing the risk assessment process, maintenance of security controls, and coordination of responses to cybersecurity incidents;

 engagement with external service providers to evaluate, enhance, or support our security measures;

 an incident response plan outlining specific procedures for managing cybersecurity incidents; and

 Cybersecurity Governance

 The governance of cybersecurity risks is a critical
function of our Board, with the Audit Committee playing a key role in the oversight of cybersecurity and related technology risks. The
Audit Committee is tasked with monitoring the effectiveness of our cybersecurity risk management program as implemented by management.

 The Audit Committee receives regular updates from
management on the state of cybersecurity risks facing the Company. This includes briefings on any significant cyber incidents and ongoing
risk management efforts. These updates enable the Audit Committee to provide informed reports on cybersecurity matters to the full Board.

 The responsibility for day-to-day management of
cybersecurity risks lies with our management team, including the Interim Chief Financial Officer. This team is at the forefront of our
cybersecurity initiatives, coordinating both internal and external resources to anticipate, identify, and mitigate cyber threats. Our
approach includes regular updates from our third-party security expert consultant, leveraging intelligence from various sources, and utilizing
advanced security tools to protect our digital environment. Our third-party security expert consultant has over 30 years of experience
with cybersecurity, information technology development and deployment, and information technology risk assessment and management, including
information security management.

 Item 2. Properties

 We currently lease an office located at 201 E
Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.

 Additionally, Proteomedix leases office and lab
space located at Wagistrasse 23, 8952 Schlieren, Switzerland. This lease expires on June 30, 2025, subject to renewal for successive two-year
terms. The lease will automatically renew unless terminated. Either party may terminate the lease with 12 months' written notice.

 Item 3. Legal Proceedings.

 From time to time, we may be involved in various
disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings.

 Item 4. Mine Safety Disclosures.

 Not applicable.

 Item 5. Market for Registrant's Common
Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

 Market Information

 Our common stock is traded on Nasdaq under the symbol "ONCO."

 Holders

 As of May 30, 2025, there were approximately 30
holders of record of our common stock. This number does not include stockholders who are beneficial owners, but whose shares are held
in street name by brokers and other nominees. This number of holders of record also does not include stockholders whose shares may be
held in trust by other entities.

 Recent Sales of Unregistered Securities

 None.

 Dividend Policy

 As of the date of this Annual Report on Form 10-K,
we have not paid any cash dividends to stockholders. The declaration of any future cash dividend will be at the discretion of our board
of directors and will depend upon our earnings, if any, our capital requirements and financial position, the general economic conditions,
and other pertinent conditions. It is our present intention not to pay any cash dividends in the foreseeable future, but rather to reinvest
earnings, if any, in our business operations.

 Item 6. Reserved.

 Item 7. Management's Discussion and Analysis of Financial
Condition and Results of Operations.

 The following discussion and analysis of our
financial condition and results of operations should be read in conjunction with our consolidated financial statements and the related
notes to those statements included elsewhere in this Annual Report on Form 10-K. In addition to historical financial information, the
following discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Some of the
numbers included herein have been rounded for the convenience of presentation. Our actual results may differ materially from those anticipated
in these forward-looking statements as a result of many factors, including those discussed under Part I. "Item 1A. Risk Factors"
and elsewhere in this Annual Report on Form 10-K.

 Overview

 We are a commercial stage biotechnology company
focused on the research, development, and commercialization of innovative solutions for men's health and oncology. Through our acquisition
of Proteomedix, which closed on December 15, 2023, we own Proclarix, an in vitro diagnostic test for prostate cancer originally developed
by Proteomedix and approved for sale in the European Union under the In Vitro Diagnostic Regulation ("IVDR"), which we anticipate
will be marketed in the U.S. as a lab developed test through our license agreement with LabCorp.

 We also own ENTADFI, an FDA-approved, once daily
pill that combines finasteride and tadalafil for the treatment of BPH, a disorder of the prostate. However, in light of (i) the time and
resources needed to continue pursuing commercialization of ENTADFI, and (ii) the Company's cash runway and indebtedness, the Company
has abandoned commercialization of ENTADFI and is working with an investment advisor to assist with the potential sale or other transaction
of the ENTADFI assets. There is currently no plan to resume commercialization of ENTADFI, and as such, if we are not able to consummate
a sale or other transaction of the ENTADFI assets, we may abandon the assets and destroy our inventory of the product. In addition, as
part of cost reduction efforts and in connection with our initial pause in commercializing ENTADFI, we terminated three employees involved
with the ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting
basis. Based on the current circumstances surrounding ENTADFI, at June 30, 2024, the ENTADFI assets were fully impaired. Refer to Note
4 and 5 in the accompanying consolidated financial statements included elsewhere in the Report for further discussion.

 The Company continues to search for a permanent
Chief Executive Officer and Chief Financial Officer.

 We are currently focusing our efforts on commercializing
Proclarix.

 Proclarix is an easy-to-use next generation
protein-based blood test that can be done with the same sample as a patient's regular Prostate-Specific Antigen ("PSA")
test. The PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample.
A high level of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections,
prostate stimulation, vigorous exercise or even certain medications. PSA results can be confusing for many patients and even physicians.
It is estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment
that impacts the physician's routine, our healthcare system, and the quality of patients' lives. Approximately 10% of all
men have elevated PSA levels., commonly referred to as the diagnostic "grey zone", of which only 20 – 40% present clinically
with cancer. Proclarix is intended for use in diagnosing these patients where it is difficult to decide if a biopsy is necessary to verify
a potential clinically significant cancer diagnosis. Proclarix helps doctors and patients with unclear PSA test results through the use
of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic support for further treatment decisions. No additional
intervention is required, and results are available quickly. Local diagnostic laboratories can integrate this multiparametric test into
their current workflow because Proclarix assays use the enzyme-linked immunosorbent assay (ELISA) standard, which most diagnostic laboratories
are already equipped to process.

 Since our
inception in October 2018 until April 2023, when we acquired ENTADFI, we devoted substantially all of our resources to performing
research and development, undertaking preclinical studies and enabling manufacturing activities in support of our product development
efforts, hiring personnel, acquiring and developing our technology and now deprioritized vaccine candidates, organizing and staffing our
company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand such
activities.

 During the third quarter of 2023, we halted our
vaccine discovery and development programs, and accordingly, we now operate in one segment: commercial. The commercial segment was new
in the second quarter of 2023 and is currently dedicated to the development and commercialization of Proclarix.

 Given Proclarix is CE-marked for sale in
the European Union, we expect to generate revenue from sales of Proclarix by 2027. Although we anticipate these sales to offset some expenses
relating to commercial scale up and development, we expect our expenses will increase substantially in connection with our ongoing activities,
as we:

 commercialize Proclarix

 hire additional personnel;

 operate as a public company; and

 obtain, maintain, expand, and protect our intellectual property portfolio.

 We rely and will continue to rely on third parties
for the manufacturing of Proclarix. We have no internal manufacturing capabilities, and we will continue to rely on third parties, of
which the main suppliers are single-source suppliers, for commercial product.

 We do not have any products approved
for sale, aside from Proclarix and ENTADFI, from which we have not generated any revenue from product sales and for which we have determined
to abandon commercialization activities To date, we have financed our operations primarily with proceeds from our sale of preferred securities
to seed investors, the initial public offering ("IPO"), and subsequent offerings of debt and equity securities. We will continue
to require significant additional capital to commercialize Proclarix, and to fund operations for the foreseeable future. Accordingly,
until such time as we can generate significant revenue, if ever, we expect to finance our cash needs through public or private equity
or debt financings, third-party (including government) funding and to rely on third-party resources for marketing and distribution arrangements,
as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches, to support our
operations.

 Some recent key developments affecting our business
include the following:

 Altos Units

 On January 23, 2024, the Company issued a
non-convertible debenture (the "Altos Debenture") in the principal sum of $5.0 million, in connection with a Subscription
Agreement, to Altos Ventures, a stockholder of the Company and related party ("Altos"). The Altos Debenture was originally
payable in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024. On April 24,
2024, the Altos Debenture was amended to extend the maturity date to the earlier of (i) the closing under the Subscription Agreement
and (ii) October 31, 2024 (the "Altos Amendment"). On September 24, 2024, upon obtaining stockholder approval and pursuant
to the Subscription Agreement, dated December 18, 2023, the Company issued an aggregate of 513,424 units (the "Units") to
Altos, each Unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant (collectively, the "Altos Warrants")
to purchase 0.3 shares of Common Stock at an exercise price of $0.04 per share. The Altos Warrants were immediately exercisable at any
time on or after the date of issuance and had a term of exercise of five (5) years from the date of issuance. The outstanding debt, as
per the Altos Debenture agreement, is considered settled through the unit issuance.

 Additional shares are issuable to Altos to the
extent Altos continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than $10.00,
as set forth in the Subscription Agreement.

 On September 24, 2024, Altos exercised all the
Altos Warrants, and the Company issued to Altos an additional 154,027 shares of Common Stock upon such exercise.

 Amended Forbearance Agreement

 On September 19, 2024, the Company entered into
an Amended and Restated Forbearance Agreement with Veru (the "Amended and Restated Forbearance Agreement" or "A&R
Forbearance Agreement"), which amends and restates the Original Forbearance Agreement in its entirety. Pursuant to the A&R Forbearance
Agreement, Veru will forbear from exercising its rights under both April Veru Note and the September Veru note, subject to the terms and
conditions set forth below.

 The A&R Forbearance Agreement extends the
due date for the April 2024 and September 2024 Veru Notes until the earlier to occur of (i) June 30, 2025 or (ii) the occurrence of any
Event of Default. The Amended and Restated Forbearance Agreement also effected certain modifications to the payment terms in the Original
Forbearance Agreement and amended certain terms of the September Veru Note as summarized below.

 Pursuant to the A&R Forbearance Agreement,
the Company agreed to make the following required payments (the "Required Payments") during the April 2024 Forbearance Period
first to accrued and unpaid interest under the April Veru note and then any remainder to the outstanding principal amount of the April
Veru Note:

 Interest at the rate of 10% per annum shall accrue on any unpaid principal balance of the April Veru Note commencing on April 20, 2024 through the date that the outstanding principal balance under the April Veru Note is paid in full;

 Monthly payments equal to 25% (increased from 15% in the Original Forbearance Agreement) of (i) the monthly cash receipts of Proteomedix for the licensing or sale of any products or services, (ii) monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix anywhere in the world, and (iii) monthly cash receipts of the Company or any of its subsidiaries for milestone payments or royalties from LabCorp cash receipts of the Company of its subsidiaries from certain sale or licensing revenues or payments (the "Ordinary Cash Revenue"), which increased amount shall begin October 20, 2024 for cash receipts in September 2024;

 Payment of 20% (increased from 10% in the Original Forbearance Agreement) of the net proceeds from certain financing or other transactions outside the ordinary course of business completed by the Company or any of its subsidiaries during the April 2024 Forbearance Period, which increased amount will begin for any net proceeds received after September 19, 2024; and

 The remaining balance of the April Veru Note will be due at the end of the April 2024 Forbearance Period.

 The Company
and Veru also agreed to the following amendments to the September Veru Note in the A&R Forbearance Agreement:

 As noted above, an extension of the maturity date to June 30, 2025;

 The accrual of interest at the rate of 10% per annum on any unpaid principal balance of the September Veru Note commencing on October 1, 2024 through the date that the outstanding principal balance under the September Veru Note is paid in full;

 Any amounts owed on the September Veru Note, including but not limited to unpaid principal and accrued interest, will be paid in cash or, upon the mutual written consent of Veru and the Company, in shares of the Company's Common Stock or a combination of cash and the Company's Common Stock;

 Following full repayment of all principal and interest under the April Veru Note, the Company will make the Required Payments first towards accrued and unpaid interest under the September Veru Note and then towards the remaining principal balance payable under the September Veru Note; and

 November Amended and Restated Forbearance Agreement
with Veru

 On November 26, 2024, the Company entered into
another Amended and Restated Forbearance Agreement with Veru (the "November Amended and Restated Forbearance Agreement" or
"November A&R Forbearance Agreement"), which amends and restates certain terms of the A&R Forbearance Agreement. Pursuant
to the November A&R Forbearance Agreement, Veru agreed to waive the due date for payment of applicable Cash Receipt Payments (as such
term is defined in the A&R Forbearance Agreement) generated in October 2024 until the Company receives funds of at least $97,000 pursuant
to its equity line of credit facility with Keystone Capital Partners LLC. In exchange, the Company agreed to increase its payments to
be made to Veru out of future financing and strategic transactions through June 30, 2025, from 20% to 25% of net proceeds generated from
such transactions. All other terms of the A&R Forbearance Agreement with Veru remain the same.

 March 2025 Amended and Restated Forbearance
Agreement with Veru on April 2025

 On March 31, 2025, Veru
and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024
Promissory Note to April 14, 2025.

 On April 23, 2025, Veru
and the Company entered into a limited waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the
April 2024 Promissory Note to June 30, 2025.

 Warrant Inducement

 On July 11, 2024, the Company entered into the
Inducement Letters with certain holders of existing preferred investment options to purchase shares of the Company's common stock
at the original exercise prices of $101.84 and $43.60 per share, issued on August 11, 2022 and August 2, 2023, respectively, pursuant
to which the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 186,466 shares of the Company's
common stock, at a reduced exercise price of $6.00 per share, in consideration for the Company's agreement to issue new preferred
investment options (the "Inducement PIOs") to purchase up to an aggregate of 559,397 shares of the Company's common
stock. Of the 559,397 PIOs issued, 186,465 have a contractual term of 5 years, while the remaining 372,932 have a contractual term of
2 years. Aside from the contractual terms, the Inducement PIOs have substantially the same terms as the Existing PIOs.

 On July 11, 2024, the Company consummated the
transaction contemplated by the Inducement Letters upon unanimous written consent of the Board (the "Warrant Inducement").
The Company received aggregate net proceeds of approximately $0.9 million from the exercise of the Existing PIOs by the holders and the
sale of the Inducement PIOs, after deducting placement agent fees and other offering expenses payable by the Company.

 The Company agreed to file a registration statement
covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs (the "Resale Registration
Statement") within 30 days after the date of the Inducement Letter and to use commercially reasonable efforts to cause such Resale
Registration Statement to be declared effective by the SEC within 60 days following the date of the Inducement Letter (or within 90 days
following the date of the Inducement Letter in the case of full review of the Resale Registration Statement by the SEC).

 The Company engaged H.C. Wainwright & Co.,
LLC ("Wainwright") to act as its exclusive placement agent in connection with the transactions summarized herein and will
pay Wainwright a cash fee equal to 7.5% of the gross proceeds received form the exercise of the Existing PIOs as well as a management
fee equal to 1.0% of the gross proceeds from the exercise of the Existing PIOs. The Company also agreed to reimburse Wainwright for its
expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement PIOS, up to $50,000 for fees and expenses
of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable expenses in the amount of $35,000.
The Company also agreed to issue to Wainwright or its designees warrants (the "Placement Agent Warrants"), and as such shares
of common stock issuable thereunder, (the "Placement Agent Warrant Shares") to purchase (i) 13,054 shares of common stock
which will have the same terms as the Inducement PIOs except for an exercise price equal to $7.50 per share and a term of five (5) years
following the date of stockholder approval and (ii) upon any exercise for cash of the Inducement PIOs, 7.5% of the aggregate exercise
price and that number of shares of common stock equal to 7.0% of the aggregate number of such shares of common stock underlying the Inducement
PIOs that have not been exercised, which will have substantially the same terms as the Placement Agent Warrants.

 The Company evaluated the terms of the Inducement
PIOs and the Wainwright Inducement Warrants (collectively, the "August 2023 Inducement Warrants"), and determined that they
should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40. The Company also evaluated
the unissued shares held in abeyance, which represent a prepaid forward contract, and determined that it is an equity instrument based
on the guidance provided in ASC 480 and ASC 815-40.

 The Warrant Inducement, which resulted in the
lowering of the exercise price of the Existing PIOs and the issuance of the Inducement PIOs, is considered a modification of the Existing
PIOs under the guidance of Accounting Standards Update ("ASU") No. 2021-04, Issuer's Accounting for Certain Modifications
or Exchanges of Equity Classified Written Call Options. The modification is consistent with the "Equity Issuance" classification
under that guidance as the reason for the modification was to induce the holders of the Existing PIOs to cash exercise their warrants,
resulting in the imminent exercise of the Existing PIOs, which raised equity capital and generated net proceeds for the Company of approximately
$0.9 million. As the Existing PIOs and the Inducement PIOs were classified as equity instruments before and after the exchange, and as
the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of approximately $1.9
million as an equity issuance cost.

 In addition, the change in fair value of the contingent
warrant liability associated with 3,729 of the August 2022 Contingent Warrants and 7,459 of the August 2023 Contingent Warrants was decreased
to $0 upon the agreement with Wainwright that all prior contingent warrants were no longer issuable or due upon the Warrant Inducement
Transaction. The fair value of the contingent warrant liability of approximately $2,700 was derecognized as of the settlement date, with
the corresponding amount, representing the fair value of the Wainwright Inducement Warrants, was recognized as additional paid-in capital.

 The Company evaluated the terms of the 39,158
Inducement Contingent Warrants (equivalent to 7.0% of the aggregate number of such shares of common stock underlying the Inducement PIOs
that have not been exercised), which are issuable upon a future inducement, and determined that they should be classified as a liability
based upon accounting guidance provided in ASC 815-40. Since the Inducement Contingent Warrants are a form of compensation to Wainwright,
the Company recorded the value of the liability of approximately $158,000 as a reduction of additional paid in capital, with subsequent
changes in the value of the liability recorded in other income (expense) in the accompanying statements of operations.

 Reverse Stock Split

 On September 24, 2024, the Company effected a
Reverse Stock Split of all shares of its issued and outstanding Common Stock at a ratio of one-for-forty (1:40). The Company accounted
for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification
("ASC") 260, Earnings Per Share. All issued and outstanding common stock, common stock warrants, and share-based
awards' exercise prices and per share data have been adjusted in the consolidated financial statements, on a retrospective basis,
to reflect the reverse stock split for all periods presented. The number of authorized shares and par value of the
preferred stock and common stock were not adjusted because of the reverse stock split.

 Conversion of Series A Preferred Stock

 On September 24, 2024, the Company issued an aggregate
of 142,749 shares of Common Stock to Veru Inc., following Veru's election to convert all the 3,000 shares of Series A preferred
stock ("Series A Preferred Stock") of the Company issued to it on September 29, 2023. The Series A Preferred Stock was originally
issued to Veru pursuant to an Amendment to the Asset Purchase Agreement, dated September 29, 2023, between the Company and Veru.

 Conversion of Series B Preferred Stock

 On September 24, 2024 the Company issued an aggregate
of 6,741,820 shares of Common Stock (the "PMX Converted Shares") to certain stockholders of the Company who were formerly
holders of outstanding capital stock or convertible securities (the "Sellers") of PMX, pursuant to the automatic conversion
of all the 2,696,729 shares of Series B preferred stock ("Series B Preferred Stock") of the Company, which Series B Preferred
Stock was originally issued to the Sellers on December 15, 2023. The Series B Preferred Stock was originally issued to the Sellers pursuant
to a Share Exchange Agreement, dated December 15, 2023, between the Company, PMX, and the Sellers (the "Share Exchange Agreement"),
and was subject to the automatic conversion following (i) the Company's receipt of stockholder approval for the issuance of the
PMX Converted Shares and ii) the effectiveness of the Reverse Stock Split, which provided for a sufficient number of authorized shares
to issue the PMX Converted Shares, as contemplated by the Share Exchange Agreement.

 Series C Preferred Stock

 On October 1, 2024, the Board authorized the Company
to create a series of 10,000 shares of preferred stock designated as "Series C convertible Preferred Stock", with a par value
of $0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible Preferred
Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. The holders
of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends actually
paid on shares of Common Stock, when and if actually paid. Each holder is entitled to convert any portion of the outstanding Preferred
Shares held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which can be determined
by dividing (x) the Conversion Amount of such Preferred Share by (y) the Conversion Price, $4.5056, subject to adjustment as provided
in the Certificate of Designations. As of May 30, 2025, an aggregate of 2,130 Series C Preferred Stock was outstanding, after redemptions
of 1,369 shares for an aggregate of $1.71 million. An additional amount of $150,531 is due to the PIPE Series C investors for 120 Series
C preferred shares that remain due from the most recent ELOC draw. These 120 shares remain subject to future redemption.

 PIPE Financing and ELOC

 On October 1, 2024, the Board authorized the Company
to create a series of 10,000 shares of preferred stock designated as "Series C convertible Preferred Stock", with a par value
of $0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible Preferred
Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. The holders
of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends actually
paid on shares of Common Stock, when and if actually paid. In addition, from and after the occurrence and during the continuance of any
Triggering Event, dividends ("Default Dividends") will accrue on the Stated Value of each Preferred Share at a rate of fifteen
percent (15.0%) (the "Default Rate") per annum. Each holder is entitled to convert any portion of the outstanding Preferred
Shares held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which can be determined
by dividing (x) the Conversion Amount of such Preferred Share by (y) the Conversion Price, $4.5056, subject to adjustment as provided
in the Certificate of Designations.

 After the Stockholder Approval Date, if a Triggering
Event occurs and is continuing at any time after the earlier of the holders' receipt of a Triggering Event Notice and such holder
becoming aware of such Triggering Event (such earlier date, the "Alternate Conversion Right Commencement Date") and ending
on the twentieth (20 th) Trading Day after the later of (x) the date of such Triggering Event is cured and (y) such holder's
receipt of a Triggering Event Notice (such ending date, the "Alternate Conversion Right Expiration Date"), and each such period,
an "Alternate Conversion Right Period"), such holder may, at such holder's option, by delivery of a Conversion Notice
to the Company (the date of any such Conversion Notice, each an "Alternate Conversion Date"), convert all, or any number of
Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an "Alternate Conversion").
Alternate Conversion Price means, with respect to any Alternate Conversion that price will be the lowest of (i) the applicable Conversion
Price as in effect on the applicable Conversion Date of the applicable Alternate Conversion, and (ii) the greater of (x) the Floor Price
and (y) 80% of the lowest VWAP of the Common Stock during the five (5) consecutive Trading Day period ending and including the Trading
Day immediately preceding the delivery or deemed delivery of the applicable Conversion Notice (such period, the "Alternate Conversion
Measuring Period").

 At any time, the Company has the right to redeem
in cash all, but not less than all, of the Preferred Shares then outstanding at a price (the "Company Optional Redemption Price")
equal to 125% of the greater of (i) the Conversion Amount being redeemed and (ii) the product of (1) the Conversion Rate with respect
to the Conversion Amount being redeemed multiplied by (2) the greatest closing sale price of the Company's Common Stock on any Trading
Day during the period commencing on the date immediately preceding the date the Company notifies the holders of its elections to redeem
and the date the Company makes the entire payment required. Upon the occurrence of a Bankruptcy Triggering Event, the Company will immediately
redeem, in cash, each of the Preferred Shares then outstanding at a redemption price equal to the greater of (i) the product of (A) the
Conversion Amount to be redeemed multiplied by (B) 125% and (ii) the product of (X) the Conversion Rate with respect to the Conversion
Amount in effect immediately following the date of initial public announcement of such Bankruptcy Triggering Event multiplied by (y) the
product of (1) 125% multiplied by (2) the greatest closing sale price of the Common Stock on any Trading Day during the period commencing
on the date immediately preceding such Bankruptcy Triggering Event and ending on the date the Company pays the entire payment required.

 In no event may any Preferred Shares be converted
(or Warrants be exercised) and shares of Common Stock be issued to any holder if after giving effect to the issuance of shares of Common
Stock upon such conversion of the Preferred Shares (or exercise of the Warrants), the holder (together with its affiliates, if any) would
beneficially own more than 4.99% of the outstanding shares of Common Stock, which we refer to herein as the "PIPE Blocker".
The PIPE Blocker may be raised or lowered to any percentage not in excess of 9.99% at the option of the applicable holder of the Preferred
Shares (or Warrants), except that any raise will only be effective upon 61-days' prior notice to the Company.

 On October 2, 2024, the Company entered into,
and sold, to six institutional investors (collectively, the "PIPE Investors"), pursuant to the securities purchase agreement
an aggregate of 3,499 shares of Series C Preferred Stock which includes an issuance of 840 shares of Series C Preferred Stock to the lead
investor in consideration for the PIPE Investors' irrevocable commitment to purchase shares of the Series C Preferred Stock, and
warrants to purchase 591,856 shares of Common Stock, (together, the "PIPE Securities") for aggregate net cash proceeds to
the Company of $1.9 million. The exercise price of the warrants is $4.38, and the warrants are exercisable six months after the issuance
date and expire on the third anniversary of the initial exercisability date.

 On October 2, 2024, the Company entered into a
Common Stock ELOC Purchase Agreement relating to a Committed Equity Facility with an institutional investor (the "ELOC Purchaser"),
whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase,
up to $25.0 million of the Company's newly issued Common Stock, subject to certain limitations. Concurrently with entering into
the ELOC Purchase Agreement, the Company also entered into a registration rights agreement with the ELOC Purchaser, pursuant to which
it agreed to provide the ELOC Purchaser with certain registration rights related to the shares issued under the ELOC Purchase Agreement
(the "ELOC Registration Rights Agreement"). In no event will the Company issue to the Purchaser under the ELOC Purchase Agreement
more than 1,658,525 shares of Common Stock, representing 19.99% of the total number of shares of Common Stock outstanding immediately
prior to the execution of the Common Stock Purchase Agreement (the "Exchange Cap"), unless (i) the Company obtains the approval
of the issuance of such shares by its stockholders in accordance with the applicable stock exchange rules or (ii) sales of Common Stock
are made at a price equal to or in excess of the lower of (A) the closing price immediately preceding the delivery of the applicable notice
to the Purchaser and (B) the average of the closing prices of the Common Stock for the five business days immediately preceding the delivery
of such notice, such that the sales of such Common Stock to the Purchaser would not count toward the Exchange Cap because they are "at
market" under applicable stock exchange rules.

 The Company may not issue or sell any shares of
Common Stock to the ELOC Purchaser under the Common Stock Purchase Agreement, if it would result in the ELOC Purchaser beneficially owning
more than 4.99% of the outstanding shares of Common Stock (the "ELOC Blocker"). The ELOC Blocker may be raised or lowered
to any other percentage not in excess of 9.99% at the option of the ELOC Purchaser, except that any raise will only be effective upon
61 days' prior notice to the Company.

 Potential Ocuvex Transaction

 On April 1, 2025, the
Company and Ocuvex Therapeutics, Inc. signed a Non-Binding Letter of Intent contemplating a potential business combination transaction
with Ocuvex. The Company and Ocuvex intend to continue negotiations to enter into a definitive agreement. Upon closing of the proposed
transaction, the Company will acquire all the issued and outstanding equity interests of Ocuvex in exchange for newly issued shares of
common stock of the Company. Immediately following the closing of the proposed transaction, the pre-closing Ocuvex equity holders will
own approximately 90% of the equity interests in the combined company.

 Certain Significant Relationships

 We have entered into grant, license and collaboration
arrangements with various third parties as summarized below. For further details regarding these and other agreements, see the section
titled "Business - Intellectual Property" and Note 6 to our consolidated financial statements included elsewhere in this Report.

 Laboratory Corporation of America

 On March 23, 2023, Proteomedix entered into a
license agreement with LabCorp pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix and other products
developed by LabCorp using Proteomedix's intellectual property covered by the license, in the United States ("Licensed Products").
In consideration for granting LabCorp an exclusive license, Proteomedix received an initial license fee in the mid-six figures upon signing
of the contract. Additionally, Proteomedix is entitled to royalty payments between 5% and 10% on the net sales recognized by LabCorp of
any Licensed Products plus milestone payments as follows:

 after the first sale of Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures;

 after LabCorp achieves a certain amount in the low seven figures in net sales of the Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures; and

 after a certain amount in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures.

 A total of $2.5 million in milestone payments
are payable under the license agreement. An additional $0.5 million was paid to Proteomedix as an initial license fee in 2023.

 LabCorp is wholly responsible for the cost, if
any, of research, development and commercialization of Licensed Products in the United States but has the right to offset a portion of
those costs against future royalty and milestone payments. Additionally, LabCorp may deduct royalties or other payments made to third
parties related to the manufacture or sale of Licensed Products up to a maximum amount of any royalty payments due to Proteomedix.

 The license agreement and related royalty payment
provisions expire during 2038, which approximates the expiration of the last patent covered by the license agreement. LabCorp has the
right to terminate the license agreement for any reason by providing 90 days written notice to Proteomedix. Either party may terminate
the license agreement due to a material breach of the terms of the license agreement with 30 days' notice, provided such breach
is not cured within the foregoing 30-day period. Finally, Proteomedix may terminate the license agreement with 60 days' notice in
the event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit the payment within the foregoing 60-day
period.

 Services Agreement

 On July 21, 2023, the Company, entered into a
Licensing and Services Master Agreement ("Master Services Agreement") and a related statement of work with IQVIA, pursuant
to which IQVIA was to provide to the Company commercialization services for the Company's products, including recruiting, managing,
supervising and evaluating sales personnel and providing sales-related services for such products, for fees totaling up to $29.1 million
over the term of the statement of work. The statement of work had a term through September 6, 2026, unless earlier terminated in accordance
with the Master Services Agreement and the statement of work. On July 29, 2023, a second statement of work was entered into with IQVIA
for certain subscription services providing prescription market data access to the Company. The fees under the second statement of work
totaled approximately $800,000, and the term was through July 14, 2025. On October 12, 2023, the Company terminated the Master Services
Agreement and the statements of work. The Company recorded net credits of approximately $0.5 million related to this contract during the
year ended December 31, 2024, which is included in selling, general and administrative expense in the accompanying consolidated statements
of operations and comprehensive loss. The Company had approximately $1.1 million and $1.8 million recorded in related accounts payable
as of December 31, 2024 and 2023, respectively, which includes amounts due for early termination of the contract. See Note 6 to our consolidated
financial statements included elsewhere in this Report.

 On January 15, 2025, the Company and IQVIA entered
into a Settlement Agreement (the "Settlement Agreement") concerning potential termination payments under the Master Services
Agreement and statements of work. Pursuant to the Settlement Agreement, the Company agreed to pay to IQVIA an aggregate of $150,000 in
exchange for a mutual release of all claims in connection with the Master Services Agreement. As a result of the Settlement Agreement,
the Company will record an adjustment of approximately $(0.9) million in accounts payable.

 Components of Results of Operations

 Selling, General and Administrative Expenses

 Selling, general and administrative expenses consist
principally of commercialization activities, payroll, and personnel expenses, including salaries
and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, information
technology costs, costs incurred with respect to acquisitions and potential acquisitions, and other general operating expenses.

 We anticipate that our selling, general and administrative
expenses related to Proteomedix will increase when compared to historical levels as a result of efforts to commercialize Proclarix, and
costs associated with integration of Proteomedix's operations.

 Research and Development Expenses

 Historically, substantially all of our research
and development expenses consisted of expenses incurred in connection with the development of our product candidates. These expenses historically
have included fees paid to third parties to conduct certain research and development activities on our behalf, consulting costs, costs
for laboratory supplies, product acquisition and license costs, certain payroll, and personnel-related expenses, including salaries and
bonuses, employee benefit costs and stock-based compensation expenses for our research and product development employees. We expense both
internal and external research and development expenses as they are incurred.

 We do not allocate our costs by product candidate,
as a significant amount of research and development expenses include internal costs, such as payroll and other personnel expenses, laboratory
supplies, and external costs, such as fees paid to third parties to conduct research and development activities on our behalf, that are
not tracked by product candidate.

 As discussed above, we have terminated the vaccine
programs that substantially all of our research and development historically related to. We do not anticipate incurring significant research
and development expenses in the near future, unless we are able to resume such activities. Predicting the timing or cost to complete our
clinical programs for future product candidates, or validation of our commercial manufacturing and supply processes is difficult and delays
may occur because of many factors, including factors outside of our control, such as regulatory approvals. Furthermore, we are unable
to predict when or if our future product candidates will receive regulatory approval with any certainty.

 Other Income (Expense)

 Other income (expense) is comprised of interest
expense on notes payable, the change in fair value of financial instruments that are recorded as liabilities, which includes the related
party subscription agreement liability and the contingent warrant liability, and other financing-related costs.

 Results of Operations

 Comparison of the Years Ended December 31, 2024 and 2023

 The following table summarizes our statements
of operations and comprehensive loss for the periods indicated:

 Year Ended
 2024

 Year Ended
 2023

 $
 Change

 %
 Change

 Revenue

 $
 2,524,116

 $

 $
 2,465,651

 4217.3
 %

 Cost of revenue

 1,469,018

 1,185,630

 283,388

 23.9
 %

 Gross profit (loss)

 1,055,098

 (1,127,165
)

 2,182,263

 (193.6
)%

 Operating expenses

 Selling, general and administrative

 $
 11,231,982

 $
 14,770,678

 (3,538,696
)

 (24.0
)%

 Research and development

 154,359

 1,949,406

 (1,795,047
)

 (92.1
)%

 Impairment of ENTADFI assets

 3,530,716

 14,687,346

 (11,156,630
)

 (76.0
)%

 Impairment of Goodwill

 32,347,000

 -

 32,347,000

 100.0
 %

 Impairment of Intangibles

 10,279,796

 -

 10,279,796

 100.0
 %

 Impairment of deposit on asset purchase agreement

 -

 3,500,000

 (3,500,000
)

 (100.0
)%

 Total operating expenses

 57,543,853

 34,907,430

 22,636,423

 64.8
 %

 Loss from operations

 (56,488,755
)

 (36,034,595
)

 (20,454,160
)

 56.8
 %

 Other income (expense)

 Loss on extinguishment of note payable

 -

 (490,000
)

 490,000

 (100
)%

 Interest expense – related party

 (534,245
)

 -

 (534,245
)

 %

 Interest expense

 (873,433
)

 (671,625
)

 (201,808
)

 %

 Interest Income

 -

 %

 Change in fair value of subscription agreement liability

 (3,259,000
)

 (134,100
)

 (3,124,900
)

 2330.3
 %

 Change in fair value of contingent warrant liabilities

 1,250,466

 (91,967
)

 1,342,433

 (1459.7
)%

 Other

 168,746

 -

 168,746

 %

 Total other (expense)

 (3,247,448
)

 (1,387,692
)

 (1,859,756
)

 %

 Loss before income taxes

 (59,736,203
)

 (37,422,287
)

 (22,313,916
)

 59.6
 %

 Income tax benefit

 1,045,180

 12,593

 1,032,587

 8199.7
 %

 $
 (58,691,023
)

 $
 (37,409,694
)

 (21,281,329
)

 56.9
 %

 Deemed dividend Series C preferred stock

 (206,404
)

 -

 (206,404
)

 %

 Net loss applicable to common stockholders'

 $
 (58,897,427
)

 $
 (37,409,694
)

 (21,487,733
)

 57.4
 %

 Revenue, Cost of Revenue, and Gross Margin

 For the year ended December 31, 2024, the Company
had $2.5 million in revenue, which was attributable to Proteomedix revenue. Cost of revenue of approximately $1.5 million, and the resulting
positive margin, is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset
of approximately $457,000, and standard cost of production and sales of $1.01 million.

 Selling, General and Administrative Expenses

 For the year ended December 31, 2024, selling,
general and administrative expenses decreased by approximately $3.5 million to $11.2 million compared to $14.8 million in 2023. The decrease
was mainly due to approximately $1.3 million in expense reduction due to the halting of most of operations in late 2023. In addition,
the Company incurred approximately $2.2 million related to the acquisition of Proteomedix, which consists primarily of transaction costs
and Proteomedix's selling, general and administrative expenses since the acquisition date.

 Research and Development Expenses

 For the year ended December 31, 2024, research
and development expenses decreased by approximately $1.8 million compared to 2023. The decrease
was primarily due to the Company's decision to deprioritize its vaccine programs and focus on commercialization activities, which
occurred during the third quarter of 2023. Decrease is also attributable due to the halting of research and development programs in late
2023 and offset by the true up of accrual estimates in Q2 2024.

 Impairments

 The Company recorded impairment charge of $3.5
million on a deposit that was made as part of the WraSer APA in 2023. In addition, the Company recorded an impairment charge of $14.7
million on the assets acquired as part of the ENTADFI acquisition during the fourth quarter of 2023.

 The Company recorded an impairment of goodwill
related to the PMX acquisition during the year ended December 31, 2024 totaling $32.3 million. The Company also recorded an impairment
of intangible assets related to the PMX acquisition during the year ended December 31, 2024 totaling $10.3 million.

 Other Income (Expense)

 Other expense incurred during the year ended December
31, 2024 increased by approximately $1.9 million compared to 2023 and relates to the change in fair value of the subscription agreement
liability of approximately $3.1 million, $0.7 million of interest expense, $0.2 million that is attributable to transaction exchange rate
gains and losses, and offset by the change in fair value of the contingent warrant liability of approximately $1.3 million.

 Income Tax Benefit

 The Company recorded an income tax benefit of
approximately $1.0 million during the year ended December 31, 2024, in connection with the acquisition accounting for the Proteomedix
transaction.

 Liquidity and Capital Resources

 The Company's operating activities to date
have been primarily devoted to seeking licenses, engaging in research and development activities, potential asset and business acquisitions,
and expenditures associated with the now halted commercial launch of ENTADFI and the commercialization of Proclarix.

 The Company has incurred substantial operating
losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of December 31, 2024,
the Company had cash of approximately $0.6 million, a working capital deficit of approximately $17.3 million and an accumulated
deficit of approximately $115.7 million. During the year ended December 31, 2024, the Company used approximately $10.5 million in cash
for operating activities. The Company's current cash balance is not sufficient to fund its operations through the end of December
2025. In December 2024, the Company began drawing on the Equity Financing Line of Credit ("ELOC"), which it entered into on
October 2, 2024, referred herein as the ELOC Purchase Agreement. These conditions raise substantial doubt about the Company's ability
to continue as a going concern within one year from the date of the issuance of these consolidated financial statements. The Company's
projections are also indicative that it is currently unable to meet its contractual commitments and obligations as they come due in the
ordinary course of business. The Company will require significant additional capital in the short-term to fund its continuing operations,
satisfy existing and future obligations and liabilities, including the remaining payments due for the acquisition of the ENTADFI assets,
and funds needed to support the Company's working capital needs and business activities. These business activities include the development
and commercialization of Proclarix, and the development and commercialization of the Company's future product candidates.

 Management's plans for funding the Company's
operations include generating product revenue from sales of Proclarix, which is still subject to further successful commercialization
activities within certain jurisdictions. Management also intends to secure additional funding through equity or debt financings if available,
and to utilize the ELOC entered into in October 2024 (see Note 9) on an as-needed basis to assist with the paydown of the notes and to
fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based on the terms of the
ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will not be sufficient
to sustain operations. In addition, there are currently no other commitments in place for further financing nor is there any assurance
that such financing will be available to sustain its operations and expand commercialization of Proclarix. If the Company is unable to
secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of Proclarix
and any future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient
to sustain operations and meet its obligations, or, if it is required to, file for bankruptcy.

 Because of historical and expected operating losses,
net operating cash flow deficits, and debts due within one year, there is substantial doubt about the Company's ability to continue
as a going concern for one year from the issuance of the consolidated financial statements, which is not alleviated by management's
plans. The consolidated financial statements have been prepared assuming the Company will continue as a going concern. These consolidated
financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

 Future Funding Requirements

 We anticipate that we will continue to incur significant
expenses for the foreseeable future as we continue to commercialize Proclarix.

 We will require significant amounts of additional
capital in the short-term, to continue to fund our continuing operations, satisfy existing and future obligations and liabilities, including
the remaining payments due under the Veru APA and other contracts entered into in support of the Company's commercialization plans,
in addition to funds needed to support our working capital needs and business activities, including the development and commercialization
of Proclarix, and the development and commercialization of our future product candidates. Until we can generate a sufficient amount of
revenue from sales of Proclarix if at all, we expect to finance our future cash needs through public or private equity or debt financings,
third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements,
or any combination of these approaches. The future sale of equity or convertible debt securities may result in dilution to our stockholders,
and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges
senior to those of our common stock. Debt financing may subject us to covenant limitations or restrictions on our ability to take specific
actions, such as incurring additional debt, making capital expenditures, or declaring dividends. There can be no assurance that we will
be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If
we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the
scope of our business activities.

 Our future capital requirements will depend on many factors, including:

 the costs of future commercialization activities, including product manufacturing, marketing, sales, royalties, and distribution, for Proclarix, and other products for which we may receive marketing approval;

 the timing, scope, progress, results and costs of research and development, testing, screening, manufacturing, preclinical and non-clinical studies and clinical trials;

 the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform field efficacy studies, require more studies than those that we currently expect or change their requirements regarding the data required to support a marketing application;

 our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

 any product liability or other lawsuits related to our product;

 the expenses needed to attract, hire and retain skilled personnel;

 the revenue, if any, received from commercial sales of Proclarix, or other products for which we may have received or will receive marketing approval;

 the costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing our patents or other intellectual property rights; and

 the costs of operating as a public company.

 A change in the outcome of any of these or other variables could significantly
change the costs and timing associated with our business activities. Furthermore, our operating plans may change in the future, and we
may need additional funds to meet operational needs and capital requirements associated with such change.

 Cash Flows

 The following table summarizes our cash flows for the periods indicated:

 Year Ended
 2024

 Year Ended
 2023

 Net cash used in operating activities

 $
 (10,495,816
)

 $
 (13,581,018
)

 Net cash used in investing activities

 (28,471
)

 (8,649,035
)

 Net cash provided by financing activities

 6,743,110

 1,035,060

 Effect of exchange rate changes on cash

 (126,658
)

 (3,331
)

 Net (decrease) in cash

 $
 (3,907,835
)

 $
 (21,198,324
)

 Cash Flows from Operating Activities

 Net cash used in operating activities for the
year ended December 31, 2024 was approximately $10.5 million, which primarily resulted from the net loss of $58.7 million. This was offset
by impairment losses of goodwill of $32.3 million related to the acquisition of Proteomedix, loss on impairment of ENTADFI assets of $3.5
million, impairment of cash the fair value of the subscription liability agreement of $3.3 million, impairment of intangibles related
to the acquisition of Proteomedix of $10.3 million, depreciation and amortization of $0.7 million noncash stock-based compensation expense
$0.4 million, change in the fair value of contingent warrant liability of $1.3 million, and a net change in our operating assets and liabilities
of $1.5 million.

 Net cash used in operating activities for the
year ended December 31, 2023 was $13.6 million, which primarily resulted from a net loss of $37.4 million. This was offset by impairment
losses of $19.3 million related to the ENTADFI assets and the WraSer APA, the fair value of the subscription liability agreement of $0.7
million, non-cash interest expense of $0.7 million, a loss on the extinguishment of a note payable of $0.5 million, noncash stock-based
compensation expense of $0.3 million, $0.3 million loss on impairment of long-lived assets, other non-cash items of $0.4 million, and
a net change in our operating assets and liabilities of $1.6 million.

 Cash Flows from Investing Activities

 Net cash used in investing activities for the
year ended December 31, 2024 was approximately $30,000, of which all was due to the purchase of property and equipment.

 Net cash used in investing activities for the year
ended December 31, 2023 was approximately $8.6 million, of which approximately $6.1 million was used for the acquisition of ENTADFI,
$3.5 million was used for the deposit in connection with the potential WraSer APA, and $0.1 million is the net change in the receivable
from related parties and purchases of long-lived assets. This was offset by approximately $1.1 million in cash acquired in connection
with the acquisition of Proteomedix.

 Cash Flows from Financing Activities

 Net cash provided by financing activities for
the year ended December 31, 2024 was approximately $6.7 million, which resulted from proceeds from issuance of notes payable for related
parties of $5.0 million, net proceeds from the exercise of preferred investment options of $0.9 million, proceeds from the purchase of
series C preferred stock of $1.9 million, and proceeds from purchases of common stock of $0.7 million. These proceeds from investing activities
was offset by payments in deferred financing costs and payments of note payable totaling $1.7 million.

 Net cash
provided by financing activities for the year ended December 31, 2023 was approximately $1.0 million, and resulted from net proceeds from
the exercise of preferred investment options in connection with the warrant inducement transaction of $2.3 million offset by $1.0 million
in principal payments on a note payable, $59,000 in purchases of treasury shares, and $205,000 of payment in deferred offering costs.

 Legal Contingencies

 From time to time, we may become involved in legal
proceedings arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses
will be incurred and that such losses can be reasonably estimated.

 Off-Balance Sheet Arrangements

 During the periods presented we did not have,
nor do we currently have, any off-balance sheet arrangements as defined in the rules and regulations of the SEC.

 Recent Accounting Pronouncements Not Yet Adopted

 See Note 3 to our consolidated financial statements
included elsewhere in this Report for more information.

 Critical Accounting Policies and Estimates

 Our consolidated financial statements have been
prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP"). The preparation of these consolidated
financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses
and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our
estimates and judgments. We base our estimates on historical experience, known trends and events and various other factors that are believed
to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets
and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions
or conditions.

 While our significant accounting policies are
described in more detail in Note 3 to our consolidated financial statements included elsewhere in this Report, we believe the following
accounting policies and estimates to be most critical to the judgments and estimates used in the preparation of our consolidated financial
statements.

 Acquisitions

 The Company evaluates acquisitions to first
determine whether a set of assets acquired constitutes a business and should be accounted for as a business combination. If the assets
acquired are not a business, the transaction is accounted as an asset acquisition in accordance with Accounting Standards Codification
("ASC") 805-50, Asset Acquisitions ("ASC 805-50"), which requires the acquiring entity to recognize
assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, except for non-qualifying assets including
financial assets such as inventory. Further, the cost of the acquisition includes the fair value of consideration transferred and direct
transaction costs attributable to the acquisition. Goodwill is not recognized in an asset acquisition and any excess consideration transferred
over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration
payments in asset acquisitions are recognized when the contingency is determined to be probable and reasonably estimable. If the assets
acquired are a business, the Company accounts for the transaction as a business combination. Business combinations are accounted for by
using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their
respective fair values. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded
as goodwill. Acquisition-related expenses are expensed as incurred, and are included in selling, general and administrative expenses in
the consolidated statements of operations and comprehensive loss.

 Goodwill and Other Intangible Assets

 Goodwill represents the excess of the cost
of a business combination over the fair value of the net assets acquired. Goodwill and intangible assets deemed to have
indefinite lives are not amortized but are subject to impairment tests on an annual basis, and whenever events or changes in circumstances
indicate that the carrying value may not be recoverable. Goodwill is allocated to the reporting unit from which it was
created. A reporting unit is an operating segment or sub-segment to which goodwill is assigned when initially recorded. The
Company tests indefinite lived intangible assets for impairment, on an annual basis in the fourth quarter, or more frequently if an event
occurs or circumstances indicate that the indefinite lived assets may be impaired. The Company may perform a qualitative assessment to
determine whether it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. If the Company
determines this is the case, the Company then performs further quantitative analysis to identify and measure the amount of goodwill impairment
loss to be recognized, if any. To perform its quantitative test, the Company compares the fair value of the reporting unit to its carrying
value. If the fair value of the reporting unit exceeds the carrying value of its net assets, goodwill is not impaired, and no
further testing is required. If the fair value of the reporting unit is less than the carrying value, the Company measures the amount
of impairment loss, if any, as the excess of the carrying value over the fair value of the reporting unit. The Company did not test
its goodwill or indefinite lived assets for impairment during the year ended December 31, 2023, given that the acquisition date occurred
after the annual testing date and given that there were no impairment indicators from the date of acquisition through the end of the reporting
period. The Company performed an evaluation of goodwill and indefinitely lived assets for impairment during the year ended December 31,
2024 and has determined that impairment of its goodwill and indefinite lived intangible assets occurred as of December 31, 2024.

 Intangible assets with finite lives are reported
at cost, less accumulated amortization, and are amortized over their estimated useful lives, starting when sales for the related product
begin. Amortization is calculated using the straight-line method, and recorded within selling, general, and administrative expenses, or
cost of revenue, depending on the nature and use of the asset.

 During the ordinary course of business, the Company
has entered into certain license and asset purchase agreements. Potential milestone payments for development, regulatory, and commercial
milestones are recorded when the milestone is probable of achievement. Upon a milestone being achieved, the associated milestone payment
is capitalized and amortized over the remaining useful life for approved products, or expensed as research and development expense for
milestones relating to products whose FDA approval has not yet been obtained.

 Impairment of Long-Lived Assets

 The Company reviews long-lived assets, including
intangible assets with finite useful lives, for impairment whenever events or changes in business circumstances indicate that the carrying
amount of the assets may not be fully recoverable (a "triggering event"). Factors that the Company considers in deciding when
to perform an impairment review include significant underperformance of the long-lived asset in relation to expectations, significant
negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is
performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result
from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated
undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount.

 Subscription Agreement

 The Subscription Agreement is accounted for as
a liability in accordance with ASC 480, Distinguishing Liabilities from Equity, ("ASC 480"), as the make-whole provision
could result in a variable number of shares being issued upon settlement. The related party subscription agreement liability is measured
at fair value at the commitment date and at each subsequent reporting period, with changes in fair value recorded as a component of other
income (expense), net in the consolidated statements of operations and comprehensive loss.

 Quantitative and Qualitative Disclosures About
Market Risk

 We are a smaller reporting company as defined
by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.

 JOBS Act

 Section 107 of the JOBS Act also provides that
an "emerging growth company" can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities
Act for complying with new or revised accounting standards. In other words, an "emerging growth company" can delay the adoption
of new or revised accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves
of this extended transition period.

 For as long as we remain an "emerging growth
company" under the recently enacted JOBS Act, we will, among other things:

 be exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act, which requires that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting;

 be permitted to omit the detailed compensation discussion and analysis from proxy statements and reports filed under the Exchange Act and instead provide a reduced level of disclosure concerning executive compensation; and

 be exempt from any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor's report on the financial statements.

 We currently intend to take advantage of some
or all of the reduced regulatory and reporting requirements that will be available to us so long as we qualify as an "emerging growth
company," including the extension of time to comply with new or revised financial accounting standards available under Section 102(b)
of the JOBS Act. Among other things, this means that our independent registered public accounting firm will not be required to provide
an attestation report on the effectiveness of our internal control over financial reporting so long as we qualify as an emerging growth
company, which may increase the risk that weaknesses or deficiencies in our internal control over financial reporting go undetected. Likewise,
so long as we qualify as an emerging growth company, we may elect not to provide you with certain information, including certain financial
information and certain information regarding compensation of our executive officers, that we would otherwise have been required to provide
in filings we make with the SEC, which may make it more difficult for investors and securities analysts to evaluate our company. As a
result, investor confidence in our company and the market price of our common stock may be materially and adversely affected.

 Item 7A. Quantitative and Qualitative Disclosures About Market Risk

 As a smaller reporting company, we are not required
to provide the information required by this item.

 Item 8. Financial Statements and Supplementary Data.

 Reference is made to pages F-1 through F-52
comprising a portion of this report, which are incorporated herein by reference.

 Item 9. Changes in and Disagreements With Accountants
on Accounting and Financial Disclosure.

 On October 15, 2024, EisnerAmper LLP ("EA")
submitted its resignation as the Company's independent registered public accounting firm, effective upon the Company's filing
of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.

 The Company's Audit
Committee of the Board (the "Audit Committee") appointed EA to serve as the Company's independent registered public
accounting firm on July 6, 2023 (the "Appointment Date"). EA's audit report on the Company's financial statements
as of, and for the fiscal year ended December 31, 2023, dated April 11, 2024, did not contain any adverse opinion or a disclaimer of opinion,
nor was it qualified or modified as to uncertainty, audit scope or accounting principles, other than that it contained an explanatory
paragraph regarding the Company's ability to continue as a going concern.

 From the Appointment
Date to the date of EA's resignation (the "Engagement Period), there were no disagreements between the Company and EA on any
matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if
not resolved to the satisfaction of EA, would have caused EA to make reference to the subject matter of the disagreements in connection
with its audit reports on the Company's financial statements for such periods.

 During the Engagement
Period, there were no "reportable events", as defined in Regulation S-K Item 304(a)(1)(v), except as previously disclosed
in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and the Company's Quarterly Reports
on Form 10-Q for the periods ended March 31, 2024, June 30, 2024, and September 30, 2024, Company management identified certain material
weaknesses in internal controls as follows: (a) the Company did not maintain an effective control environment with adequate segregation
of duties with respect to cash disbursements; (b) the Company did not have an effective risk assessment process and effective monitoring
of compliance with established accounting policies and procedures, and did not demonstrate a sufficient level of precision in the application
of the Company's controls, including the maintenance of board committee minutes and unanimous written consents; (c) the Company's
controls over the approval and reporting of expenses paid with the Company's credit cards and certain bank wires were not designed
and maintained to achieve the Company's objectives; (d) the Company lacked accounting resources to maintain optimal segregation
of duties, maintain adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in
order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial
statements; (e) the Company did not maintain adequate controls for the timely identification, approval or reporting of related party transactions,
and (f) the Company did not maintain effective controls to ensure information technology policies and procedures set the tone at the top,
to mitigate risks and achieve information technology objectives and ITGCs in the change management, logical security and computer
operations domains.

 Effective February 13, 2025, the Audit Committee
authorized the appointment of MaloneBailey LLP (" MaloneBailey ") as the Company's new independent registered public
accounting firm for the fiscal year ended December 31, 2024, and MaloneBailey was appointed as the Company's independent registered
public accounting firm. During the Company's two most recent fiscal years ended December 31, 2024 and 2023, and the subsequent interim
period through February 13, 2025, neither the Company nor anyone acting on behalf of the Company had consulted MaloneBailey regarding
either: (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit opinion
that might be rendered on the Company's financial statements, nor did MaloneBailey provide a written report or oral advice to the
Company that MaloneBailey concluded was an important factor considered by the Company in reaching a decision as to the accounting, auditing
or financial reporting issues; or (ii) any matter that was either the subject of a "disagreement" (as defined in Item 304(a)(1)(iv)
of Regulation S-K and the related instructions) or a "reportable event" (as described in Item 304(a)(1)(v) of Regulation S-K).

 Item 9A. Controls and Procedures.

 Evaluation of Disclosure Controls and Procedures

 The Sarbanes-Oxley Act requires, among other things,
that we maintain effective disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) that are designed to ensure
that information required to be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended, is
recorded, processed, summarized and reported within the appropriate time periods, and that such information is accumulated and communicated
to the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure.
 Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer has evaluated the effectiveness of our disclosure controls and procedures. Management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily
applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on that evaluation, our Chief
Executive Officer and Chief Financial Officer has concluded that the Company's disclosure controls and procedures were not effective
as of December 31, 2024, as a result of the material weaknesses described below.

 Management's Annual Report on Internal
Control Over Financial Reporting

 Our management is responsible for establishing
and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act). Our management
assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this assessment, our management
used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO") in Internal Control-Integrated
Framework (2013 framework).

 Based on our assessment under the framework in
Internal Control-Integrated Framework (2013 framework), our management concluded that our internal control over financial reporting was
not effective as of December 31, 2024, due to the existence of the material weaknesses described below.

 A material weakness in internal control is a deficiency
in internal control, or combination of control deficiencies, that adversely affects the Company's ability to initiate, authorize,
record, process, or report external financial data reliably in accordance with GAAP such that there is more than a remote likelihood that
a material misstatement of the Company's annual or interim financial statements will not be prevented or detected.

 This Annual Report on Form 10-K does not include
an attestation report of our registered public accounting firm regarding internal control over financial reporting. Our auditors will
not be required to formally opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 until
we are no longer an "emerging growth company" as defined in the JOBS Act.

 Material Weaknesses
in Internal Control Over Financial Reporting

 We have identified the
following internal control deficiencies, which we believe to be material weaknesses as of December 31, 2024:

 We did not maintain an effective control environment as there was an inadequate segregation of duties with respect to certain cash disbursements.

 We do not have an effective risk assessment process and effective monitoring of compliance with established accounting policies and procedures, and do not demonstrate a sufficient level of precision in the application of our controls.

 Our controls over the approval and reporting of expense payments were not designed and maintained to achieve the Company's objectives.

 We do not yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions."

 We have insufficient accounting resources to maintain adequate segregation of duties, maintain adequate controls over the approval and posting of journal entries, and to provide optimal levels of oversight in order to process financial information in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements.

 The Company did not design, implement and
maintain effective controls to ensure information technology ("IT") policies and procedures set the tone at the top, to mitigate
the risks to the achievement of IT objectives and ITGCs in the change management, logical security and computer operations domains. Specifically,
the design and implementation of user authentication, user access privileges, data backup and data recovery controls as well as the monitoring
controls of excessive user access and elevated privileged access to financial applications and data were not appropriately designed and
maintained. In addition, these inadequate ITGC controls combined with the use of personal devices to conduct business, can lead to an
IT control environment vulnerable to breaches and social engineering persuasion.

 The above material weaknesses
did not result in a material misstatement of our previously issued financial statements but could have resulted in material misstatements
of our account balances or disclosures of our annual or interim financial statements that would not be prevented or detected. We have
developed a remediation plan for these material weaknesses which is described below in Remediation of Material Weaknesses.

 Remediation of Material Weaknesses

 As of the date of this
Annual Report on Form 10-K, management is re-assessing the design of controls and modifying processes designed to improve our internal
control over financial reporting and remediate the control deficiencies that led to the material weaknesses, including but not limited
to (a) improving consistency in change management supported by standard operating procedures to govern the authorization, testing and
approval of changes to information technology systems supporting all of the Company's internal control processes, (b) enhancing
design and implementation of our control environment, including the expansion of formal accounting and IT policies and procedures and
financial reporting controls, (c) continuing to identify and design and implement effective review and approval controls, and (d) implementing
appropriate timely review and oversight responsibilities within the accounting and financial reporting functions and ensuring appropriate
segregation of duties.

 We will consider the
material weaknesses remediated after the applicable controls operate for a sufficient period of time, and management has concluded, through
testing, that the controls are operating effectively.

 The process of designing
and implementing an effective accounting and financial reporting system is a continuous effort that requires us to anticipate and react
to changes in our business and the economic and regulatory environments and to expend significant resources to maintain an accounting
and financial reporting system that is adequate to satisfy our reporting obligations. As we continue to evaluate and take actions to improve
our internal control over financial reporting, we may determine to take additional actions to address control deficiencies or determine
to modify certain of the remediation measures described above. We cannot assure you that the measures we have taken to date, or any measures
we may take in the future, will be sufficient to remediate the material weakness we have identified or avoid potential future material
weaknesses.

 Inherent Limitation
on the Effectiveness of Internal Control Processes

 Our Interim Chief Executive
Officer and Interim Chief Financial Officer does not expect that our disclosure controls or our internal control over financial reporting
will prevent all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent
limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error
or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by
management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures
may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur
and not be detected.

 Changes in Internal Control over Financial
Reporting

 During the year ended December 31, 2024, there
were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange
Act) that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 Item 9B. Other Information.

 None.

 Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.

 None.

 Item 10. Directors, Executive Officers, and
Corporate Governance.

 Directors and Executive Officers

 The following table provides information regarding our executive officers
and directors as of May 30, 2025:

 Name

 Age

 Position(s)

 Executive Officers and Directors

 Interim Chief Executive Officer, Interim Chief Financial Officer

 Non-Employee Directors

 Andrew Oakley

 Non-Executive Chairman

 Simon Tarsh

 Timothy Ramdeen

 Thomas Meier

 Ajit Singh

 Executive Officers and Directors

 Executive Officers and Directors

 Ms. Fedasz has helped companies raise capital,
model and forecast business, manage cash flow and conduct mergers and acquisitions. She is a dynamic, data-driven executive with a bold,
high-growth mindset. From January 2023 to June 2024, Ms. Fedasz worked with various clients, including a not-for-profit and an early-stage
artificial intelligence and data-driven health and wellness tracker. From February 2022 to December 2022, Ms. Fedasz served as Head of
Business Development for Evofem Biosciences, a Nasdaq-listed public biotech company developing innovative products for women's health.
From August 2019 to October 2021, Ms. Fedasz served in various positions of increasing responsibility, including Chief Financial Officer,
at IDW Media Holdings, a micro-cap media company, where she managed the company's initial public offering. From April 2018 to August 2019,
Ms. Fedasz served as Chief Financial Officer of MOCEAN, an integrated agency for entertainment, gaming, and brands. Ms. Fedasz's breadth
of experience has seen her lead teams in media, technology, services, manufacturing, and education, and she has worked with companies
whose clients and customers include Fortune 500 companies such as Netflix, Disney, Amazon, Apple, Activision, and EA. Ms. Fedasz received
an MBA with an emphasis in finance from Columbia Business School and a BA from University California at Los Angeles (UCLA). She holds
an inactive CPA in the state of California.

 Non-Executive Directors

 Andrew Oakley, our Non-Executive Chairman
since February 2025, is an experienced pharmaceutical and biotech industry professional. Previously, he held CFO positions at listed pharmaceutical
companies Autolus Therapeutics plc (NASDAQ: AUTL) from 2018 to 2022 and Sosei Group (TSE:4565) from 2017 to 2018, as well as Vectura Group
plc (LSE: VEC) and Actelion Ltd, where he led the finance function for over a decade. Additionally, he is a board member at a number of
privately held Biotech companies. Mr. Oakley holds a Bachelor of Economics Degree from Macquarie University and an MBA from London Business
School and has been a Member of the Australian Institute of Chartered Accountants since 1987.

 Simon Tarsh, one of our directors since
August 2022, has more than 40 years of financial experience, working in both the UK and the U.S. He has recently retired from Deloitte
Consulting LLP, where he was a Senior Managing Director in Finance and Enterprise Performance Practice, where he had served global clients
since 2007. He led a growing global practice focused around Operational Transformation, including supporting Carve Out transactions, joint
ventures and hybrid structures, both in the US and in international locations, such as India, China, Eastern Europe and Latin America.
He supported high growth companies with their finance operations as they globalized, and was able to advise them on their expansion, while
balancing growth with appropriate controls. Prior to moving to the United States in 2007, Mr. Tarsh's consulting career began with
PA Consulting Group, London in 1988, where he was elected as a Partner in 1997, and he built ISG's business process outsourcing
advisory practice in Europe between 2001 and 2006. Mr. Tarsh's early career was in finance, working with Marathon Oil and Dow Chemical,
and during this period, he qualified as a Chartered Accountant. Mr. Tarsh received a Bachelor of Science undergraduate degree in Business
and Administration from the University of Salford, Manchester, UK in 1981, and an MBA from City University Business School, London, UK
in 1988. He is a Fellow of the Chartered Institute of Management Accountants (1984), which is considered as a CPA equivalent. Mr. Tarsh's
deep financial experience at Deloitte Consulting LLP for fifteen years offers valuable insights to our Board, particularly given the enhanced
accounting rules and regulations affecting public companies.

 Timothy Ramdeen, one of our directors since
January 2023, has nearly a decade of experience in private equity and hedge fund investing, capital markets, and company formation. Since
June 2022, Mr. Ramdeen has been founder and managing partner of Dharma Capital Advisors, an investment and advisory firm focused on early-stage
private and public companies. From March 2021 to March 2022, Mr. Ramdeen was co-founder, chief investment officer, and portfolio manager
at Sixth Borough Capital Management, a multi-stage, event-driven hedge fund focused on both private and public equities. Since 2022, Mr.
Ramdeen has been the co-founder of Amplexd Therapeutics, which is a women's health/biotechnology company focused on providing low-cost,
effective, safe and accessible treatments for early cervical and HPV-related cancers worldwide. Mr. Ramdeen also serves as a corporate
advisor/board member to multiple early-stage companies and investment funds. Previously, Mr. Ramdeen was the fifth hire at Altium Capital
Management ("Altium"), a healthcare-focused investment firm, where from July 2019 to March 2021 he served as the sole investment
analyst on the private capital markets/special situations desk (privately-negotiated financings, direct investments, event-driven long/short,
and private to public investments in micro and small-cap companies). During his tenure at Altium, Mr. Ramdeen was instrumental in co-creating
the firm's SPAC and reverse merger investment efforts and establishing extensive relationships with sell-side constituents, buy-side
counterparts, and hundreds of private and publicly traded companies across biotechnology, therapeutics, healthcare services, medical devices
and medtech. From 2017 to 2018, Mr. Ramdeen worked for Brio Capital Management, an event-driven hedge fund focused on small and micro
cap equities. Mr. Ramdeen received his B.S. in Biology from Temple University, where he conducted scientific research across neurology,
oncology, and developmental biology. In addition, Mr. Ramdeen earned his MBA in Finance from NYU Stern School of Business. Mr. Ramdeen
brings to our Board extensive experience in capital advisement and company development, specifically within the life science industry
and for publicly traded companies.

 Thomas Meier, one of our directors since
February 1, 2024, has close to 25 years' experience as a life-science and biotech entrepreneur, executive manager, and board member.
Since June 2022, Dr. Meier has served as Chairman of, and member of the Audit and Compensation Committees of, Santhera Pharmaceuticals
Holding AG (SIX: SANN), a publicly listed Swiss specialty pharmaceutical company focused on the development and commercialization of innovative
medicines for rare neuromuscular and pulmonary diseases. Dr. Meier has served on the board of Santhera since 2017 and stepped down as
the company's CEO in November 2019 after having served 15 years as executive manager, the last 8 years as CEO. In 2020, Dr. Meier
became managing partner of Viopas Venture Consulting GmbH, a Swiss consultancy and advisory firm for the healthcare industry. Since 2020,
Dr. Meier has served as a board member of Novaremed AG, a privately held Swiss company developing innovative treatment options for the
management of chronic pain and alternatives to opioids. Dr. Meier has served on Novaremed's Audit Committee since October 2021 and
became Executive Chairman of the company in January 2024. Since January 2022, Dr. Meier also serves on the board of Visgenx Inc. (USA).
In September 2021, he co-founded SEAL Therapeutics AG, a privately owned Swiss gene therapy company for which he also serves as Chairman.
Between July 2020 and November 2021, he served as Chairman of privately held Pharmabiome AG (Switzerland). Dr. Meier has a PhD in Biology
and qualified as lecturer in neurosciences at the Biozentrum, University of Basel (Switzerland). Dr. Meier brings to our board experience
as an internationally recognized scientist with track record in clinical research of orphan diseases.

 Ajit Singh, one of our directors since
February 7, 2024, is a Partner at Silicon Valley based Artiman Ventures, focused on early-stage technology and life science investments,
with over $1 billion in assets under management. Besides serving on the board of directors of Artiman portfolio companies, he has served
on the boards of Sofie Biosciences, a PET radiopharmaceuticals company focused on Oncology and Neurology, Leo Cancer Care, focused on
radiation oncology since 2013, Artidis, an oncology diagnostics company with nanomechanical biomarkers for cancer, and Chronus Health,
in the area of Point-of-Care diagnostics since 2023. He also serves on the Board of Trustees of American Association for Cancer Research
(AACR) Foundation, the oldest and the largest cancer research organization globally. Dr. Singh is an Adjunct Professor in the School of
Medicine at Stanford where he teaches clinical diagnostics and entrepreneurship. In the past, Dr. Singh has served as a Lead Director
on the board of directors of Max Healthcare, and as a Senior Advisor to the Tata Trusts Cancer program, which developed a "plan
centrally, deliver locally" platform for cancer care, and delivered it via comprehensive cancer centers built bespoke with funding
from the Tata Group. Until 2023, he also served on the board of directors of Cadila Pharmaceuticals. Prior to joining Artiman, Dr. Singh
was the President and CEO of BioImagene, a company specializing in AI-based Cancer Diagnostics, based in California. BioImagene was acquired
by Roche Pharmaceuticals in September 2010. Before BioImagene, Dr. Singh spent nearly twenty years at Siemens in various roles, in the
United States and Germany, most recently as the global CEO of Siemens Oncology, and Siemens Digital Imaging Systems. Before transitioning
to these executive responsibilities, Dr. Singh spent several years in R&D at Siemens Research in Princeton, responsible for research
in the areas of artificial intelligence and robotics. During this time, he concurrently served as an adjunct faculty at Princeton University.
Dr. Singh has a Ph. D. in Computer Science from Columbia University, a Master's degree in Computer Engineering from Syracuse University,
and a Bachelor's in Electrical Engineering from Indian Institute of Technology (IIT) in Varanasi, India. He has published two books
and numerous refereed articles and holds five patents. His Top-10 Book Review is carried by various blogs and reading journals in December
every year. Mr. Singh brings to our board significant experience in the biotech industry and diagnostic field, particularly in a commercial
execution capacity.

 Board of Directors and Corporate Governance

 General

 Our business and affairs are organized under the
direction of our Board, which currently consists of five members. Our Board is divided into three classes, Class I, Class II and Class
III, with members of each class serving staggered three-year terms. Our directors are divided among the three classes as follows:

 the Class I directors are Simon Tarsh and Thomas Meier, and their term will expire at our 2025 annual meeting of stockholders;

 the Class II director is Andrew Oakley, and his term will expire at our 2026 annual meeting of stockholders; and

 the Class III directors are Timothy Ramdeen and Ajit Singh, and their term will expire at our 2025 annual meeting of stockholders.

 Our Amended and Restated Certificate of Incorporation
and our Amended and Restated Bylaws provide that the authorized number of directors may be changed only by resolution of the Board. Our
directors hold office until the earlier of their death, resignation, removal, or disqualification, or until their successors have been
elected and qualified. Our board of directors does not have a formal policy on whether the roles of Chief Executive Officer and Chairman
of our Board should be separate. The primary responsibilities of our Board are to provide oversight, strategic guidance, counselling,
and direction to our management.

 We have no formal policy regarding board diversity.
Our priority in selection of board members is identification of members who will further the interests of our stockholders through his
or her established record of professional accomplishment, the ability to contribute positively to the collaborative culture among board
members, knowledge of our business and understanding of the competitive landscape.

 Directors and Executive Officers Qualifications

 We believe that the collective skills, experiences,
and qualifications of our directors provide our Board with the expertise and experience necessary to advance the interests of our stockholders.
In selecting directors, the Board considers candidates that possess qualifications and expertise that will enhance the composition of
the Board. Nominees for director will be selected on the basis of, among other things, leadership experience, knowledge, skills, expertise,
integrity, diversity, ability to make independent analytical inquiries, understanding of the Company's business environment and
willingness to devote adequate time and effort to Board responsibilities. The Nominating & Corporate Governance Committee may require
certain skills or attributes, such as financial or accounting experience, to meet specific board needs that arise from time to time and
will also consider the overall experience and makeup of its members to obtain a broad and diverse mix of board members. We believe that
our directors should have the highest professional and personal ethics and values, consistent with our longstanding values and standards.
They should have broad experience at the policy-making level in business, exhibit commitment to enhancing stockholder value and have sufficient
time to carry out their duties and to provide insight and practical wisdom based on their past experience.

 Committees of the Board

 Our Board has established three standing committees—audit,
compensation and nominating and corporate governance—each of which operates under a charter that has been adopted by our Board.
Copies of each committee's charter are posted on the "Investor Relations" section of our website, which is located at
  Each committee has the composition and responsibilities described
below. Our Board may from time to time establish other committees.

 Audit Committee

 Our audit committee (" Audit Committee ")
consists of Simon Tarsh, who is the chair of the committee, Timothy Ramdeen, and Andrew Oakley. Our Board has determined that each of
the members of our Audit Committee satisfies the Nasdaq Marketplace Rules and SEC independence requirements. The functions of this committee
include, among other things:

 evaluating the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or engage new independent auditors;

 reviewing and approving the engagement of our independent auditors to perform audit services and any permissible non-audit services;

 reviewing our annual and quarterly financial statements and reports, including the disclosures contained under the caption "Management's Discussion and Analysis of Financial Condition and Results of Operations" and discussing the statements and reports with our independent auditors and management;

 reviewing with our independent auditors and management significant issues that arise regarding accounting principles and financial statement presentation and matters concerning the scope, adequacy, and effectiveness of our financial controls;

 reviewing and approving, in accordance with the Company's policies, any related party transaction as defined by applicable rules and regulations

 reviewing our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented; and

 reviewing and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.

 The Board has determined
that Simon Tarsh qualifies as an "audit committee financial expert" within the meaning of applicable SEC regulations and meets
the financial sophistication requirements of the Nasdaq Marketplace Rules. In making this determination, the Board has considered Mr.
Tarsh's extensive financial experience and business background. Both our independent registered public accounting firm and management
periodically meet privately with our Audit Committee.

 Compensation Committee

 Our compensation committee (" Compensation
Committee ") consists of Thomas Meier, who is the chair of the committee, Simon Tarsh, and Timothy Ramdeen. Our board of directors
has determined that each of the members of our Compensation Committee is an outside director, as defined pursuant to Section 162(m) of
the Internal Revenue Code of 1986, as amended, or the Code, and satisfies the Nasdaq Marketplace Rules independence requirements. The
functions of this committee include, among other things:

 reviewing, modifying, and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall compensation strategy and policies;

 reviewing and approving the compensation, the performance goals, and objectives relevant to the compensation, and other terms of employment of our executive officers;

 reviewing and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive plans, compensation plans and similar programs advisable for us, as well as modifying, amending, or terminating existing plans and programs;

 reviewing and approving the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory arrangements for our executive officers;

 reviewing with management and approving our disclosures under the caption "Compensation Discussion and Analysis" in our periodic reports or proxy statements to be filed with the SEC; and

 preparing the report that the SEC requires in our annual proxy statement.

 Nominating and Corporate Governance Committee

 Our nominating and corporate governance committee
(" Nominating Committee ") consists of Timothy Ramdeen, who is the chair of the committee, and Simon Tarsh. Our Board
has determined that each of the members of this committee satisfies the Nasdaq Marketplace Rules independence requirements. The functions
of this committee include, among other things:

 identifying, reviewing, and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;

 evaluating director performance on the board and applicable committees of the board and determining whether continued service on our board is appropriate;

 evaluating, nominating, and recommending individuals for membership on our board of directors; and

 evaluating nominations by stockholders of candidates for election to our board of directors.

 Board Leadership Structure

 Our board of directors is free to select the Chairman
of the board of directors and the Chief Executive Officer in a manner that it considers to be in the best interests of our company at
the time of selection. Currently, Karina Fedasz serves as our Interim Chief Executive Officer and Interim Chief Financial Officer. All
five members of our board of directors have been deemed to be "independent" by the board of directors, which we believe provides
sufficient independent oversight of our management.

 Our board of directors, as a whole and also at
the committee level, plays an active role overseeing the overall management of our risks. Our Audit Committee reviews risks related to
financial and operational items with our management and our independent registered public accounting firm. Our board of directors is in
regular contact with our Chief Executive Officer, who reports directly to the board of directors and supervises day-to-day risk management.

 Role of Board in Risk Oversight Process

 We face a number of risks, including those described
under the caption "Risk Factors" contained elsewhere in this Report. Our board of directors believes that risk management
is an important part of establishing, updating, and executing our business strategy. Our board of directors has oversight responsibility
relating to risks that could affect the corporate strategy, business objectives, compliance, operations, and the financial condition and
performance of our Company. Our board of directors focuses its oversight on the most significant risks facing us and, on our processes
to identify, prioritize, assess, manage, and mitigate those risks. Our board of directors receives regular reports from members of our
senior management on areas of material risk to us, including strategic, operational, financial, legal and regulatory risks. While our
board of directors has an oversight role, management is principally tasked with direct responsibility for management and assessment of
risks and the implementation of processes and controls to mitigate their effects on us.

 Our board is generally responsible for the oversight
of corporate risk in its review and deliberations relating to our activities. Our principal source of risk falls into two categories,
financial and product commercialization. Our Audit Committee oversees management of financial risks; our board regularly reviews information
regarding our cash position, liquidity, and operations, as well as the risks associated with each. The board regularly reviews plans,
results and potential risks related to our product offerings, growth and strategies. Our Compensation Committee oversees risk management
as it relates to our compensation plans, policies and practices for all employees including executives and directors, particularly whether
our compensation programs may create incentives for our employees to take excessive or inappropriate risks which could have a material
adverse effect on our company.

 Board Member Attendance at Annual Stockholder Meetings

 Although we do not have a formal policy regarding director attendance
at annual stockholder meetings, directors are encouraged to attend these annual meetings. All of our directors attended our 2024 virtual
annual meeting of stockholders held on September 5, 2024

 Number of Meetings

 During the fiscal year ended December 31, 2024,
our Board met eighteen times, the audit committee met five times, the compensation committee met four times, and the nominating and corporate
governance committee met two times. In the fiscal year ended December 31, 2024, each of our directors attended at least 75% of the meetings
of the Board and committees on which he served as a member.

 Code of Business Conduct and Ethics

 We have adopted a written code of business conduct
and ethics that applies to our directors, officers, and employees, including our principal executive officer, principal financial officer,
principal accounting officer or controller, or persons performing similar functions. The code of business conduct and ethics is posted
on our website at www.onconetix.com. We expect that any amendments or waivers to the code that are required by law or Nasdaq Marketplace
Rules will be disclosed on our website.

 Insider Trading Policy

 We have adopted insider trading policies and procedures
governing the purchase, sale, and/or other dispositions of our securities by directors, officers, and employees, which are reasonably
designed to promote compliance with insider trading laws, rules and regulations, and applicable Nasdaq listing standards (the " Insider
Trading Policy ").

 The foregoing
description of the Insider Trading Policy does not purport to be complete and is qualified in its entirety by the terms and conditions
of the Insider Trading Policy, a copy of which is attached hereto as Exhibit 19 and is incorporated herein by reference.

 Compensation Recovery Policy

 On January 17, 2024, our Board adopted a policy
(commonly known as a "clawback" policy) which provides for the recovery of erroneously awarded incentive compensation to certain
of our officers in the event that we are required to prepare an accounting restatement due to material noncompliance by us with any financial
reporting requirements under the federal securities laws. This policy is designed to comply with Section 10D of the Securities Exchange
Act of 1934, as amended, related rules and the listing standards of Nasdaq Stock Market or any other securities exchange on which our
shares are listed in the future. The policy is administered by our Board or, if so designated by the Board, the Compensation Committee.
Any determinations made by the Board shall be final and binding on all affected individuals.

 The individuals covered by the policy (the "Covered
Executives") are any current or former employee who is or was identified as our president, principal financial officer, principal
accounting officer (or if there is no such accounting officer, the controller), any vice-president in charge of a principal business unit,
division, or function (such as sales, administration, or finance), any other officer who performs a policy-making function, or any other
person (including any executive officer of our subsidiaries or affiliates) who performs similar policy-making functions for us.

 The policy covers our recoupment of "Incentive-Based
Compensation" (as defined in the policy) received by a person after beginning service as a Covered Executive and who served as a
Covered Executive at any time during the performance period for that Incentive-Based Compensation. In the event we are required to prepare
an accounting restatement, the policy requires us to recover, reasonably promptly, any excess incentive compensation (as determined by
our Board or Compensation Committee) received by any Covered Executive during the three completed fiscal years immediately preceding the
date on which we are required to prepare such accounting restatement.

 The foregoing description of our clawback does
not purport to be complete and is qualified in its entirety by the terms and conditions of such policy, a copy of which is filed as an
exhibit to the registration statement filed on October 8, 2021 and is incorporated herein by reference.

 Communications with the Board

 Any stockholder or any other interested party
who desires to communicate with our Board, our non-management directors, or any specified individual director, may do so by directing
such correspondence to the attention of the Interim Chief Executive Officer, Onconetix, Inc., 201 E. Fifth Street, Suite 1900, Cincinnati,
OH. The Interim Chief Executive Officer will forward the communication to the appropriate director or directors as appropriate.

 Delinquent Section 16(a) Reports

 Section 16(a) of the Exchange Act requires the
Company's directors, executive officers, and persons who own more than 10% of a registered class of the Company's equity securities,
to file with the SEC reports of beneficial ownership and reports of changes in beneficial ownership in the Company's securities.
Based solely upon a review of Forms 3, 4 and 5, and amendments thereto, filed electronically with the SEC during the year ended December
31, 2024, the Company believes that all Section 16(a) filings applicable to its directors, officers, and 10% stockholders were filed on
a timely basis during the year ended December 31, 2024, except that due to an administrative oversight, a Form 4 was not timely filed
to report a transaction that occurred in December 2024 by each of Christian Br hlmann and Ralph Schiess.

 Item 11. Executive Compensation.

 Summary Compensation Table

 The following table sets forth total compensation
paid to our named executive officers for the years ended December 31, 2024 and 2023. Individuals we refer to as our "named executive
officers" include (i) all individuals serving as our Chief Executive Officer during the fiscal year ended December 31, 2024; (ii)
our two most highly compensated executive officers other than our Chief Executive Officer who were serving as executive officers at the
end of the fiscal year ended December 31, 2024, whose salary and bonus for services rendered in all capacities exceeded $100,000 during
the fiscal year ended December 31, 2024 and (iii) up to two of our most highly compensated executive officers other than our Chief Executive
Officer who served as executive officers during the fiscal year ended December 31, 2024 but not at the end of the fiscal year ended December
31, 2024 whose salary and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2024.

 Name and Principal Position

 Year

 Salary
 ($)

 Bonus
 ($)

 Stock
 Awards
 ($) (1)

 Option
 Awards
 ($) (1)

 All
 Other
 Compensation
 ($)

 Total
 ($)

 Ralph Schiess (2)

 2024

 265,176

 40,000
 (3)

 -

 -

 -

 305,176

 Former Chief Executive Officer and Former Chief Science Officer

 2023

 11,228

 94,317

 -

 -

 -

 105,545

 Neil Campbell (4)

 2024

 5,481

 -

 -

 -

 158,333
 (5)

 163,814

 Former Chief Executive Officer

 2023

 114,792

 75,000

 -

 186,377

 -

 376,169

 Bruce Harmon (6)

 2024

 166,491

 -

 -

 -

 66,153
 (7)

 232,644

 Former Chief Financial Officer

 2023

 78,542

 24,375

 -

 62,126

 -

 165,043

 Christian Br hlmann (8)

 2024

 265,176

 -

 -

 -

 -

 265,176

 Former Chief Strategy Officer

 2023

 11,228

 94,317

 -

 -

 81,250

 186,795

 Karina Fedasz (9)

 2024

 197,125

 -

 -

 -

 -

 197,125

 Interim Chief Executive Officer and Interim Chief Financial Officer

 2023

 -

 -

 -

 -

 -

 -

 (1)

 This figure represents the aggregate grant date fair value of stock-based awards granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718. Assumptions used in the calculation of these amounts are included in the notes to our consolidated financial statements included elsewhere in this Report. Does not include restricted stock units ("RSUs") granted to Ralph Schiess and Christian Br hlmann, as such RSUs were granted in exchange for options to purchase shares of Proteomedix AG ("PMX"), pursuant to the Share Exchange Agreement, dated December 13, 2023, between the Company and PMX, and not as compensation for services rendered to the Company.

 (2)

 Mr. Schiess was appointed as Interim Chief Executive Officer on January 12, 2024 and as Chief Science Officer on December 15, 2023. His salary for 2023 is noted as pro-rata for such time as effective in 2023. The bonus for Mr. Schiess noted in 2023 is for the amount earned in 2023 but paid in full in 2024.

 (3)

 Mr. Schiess was awarded a bonus of $40,000 for his role as Interim Chief Executive Officer. A 2024 bonus for services rendered as Chief Science Officer during the fiscal year ended December 31, 2024 is omitted as it cannot be calculated because it has not yet been determined. If and when such amount becomes calculable in whole or part, the Company will disclose such amounts on a Current Report on Form 8-K

 (4)

 Mr. Campbell was appointed by the Board to serve as Chief Executive Officer on October 4, 2023, and resigned on January 10, 2024.

 (5)

 Mr. Campbell received a severance payment of $158,333,

 (6)

 Mr. Harmon was appointed by the Board to serve as Chief Financial Officer on October 4, 2023 and resigned as Chief Financial Officer on June 8, 2024.

 (7)

 Mr. Harmon received a severance of $66,153 upon his resignation.

 (8)

 Mr. Br hlmann was appointed as Chief Strategy Officer on December 15, 2023. His salary for 2023 is noted as pro-rata for such time as effective in 2023. The bonus for Mr. Br hlmann noted in 2023 is for the amount earned in 2023 but paid in full in 2024. A 2024 bonus for services rendered as Chief Strategy Officer during the fiscal year ended December 31, 2024 is omitted as it cannot be calculated because it has not yet been determined. When such amount becomes calculable in whole or part, the Company will disclose such amounts on a Current Report on Form 8-K.

 (9)

 Ms. Fedasz was appointed Interim Chief Financial Officer effective June 10, 2024 and Interim Chief Executive Officer effective April 2, 2025.

 Employment Agreements of Named Executive Officers

 Set forth below is a summary of many of the material
provisions of the employment agreements with our named executive officers and other executive officers, of which summaries do not purport
to contain all of the material terms and conditions of each such agreement.

 Neil Campbell

 In connection with Dr. Campbell's appointment,
the Company and Dr. Campbell entered into an employment agreement (the "Campbell Employment Agreement"), pursuant to which
Dr. Campbell served as President and Chief Executive Officer of the Company and was paid a signing bonus of $75,000 and an annual base
salary of $475,000. In addition, Dr. Campbell was entitled to receive, subject to employment by the Company on the applicable date of
the bonus payout, an annual target discretionary bonus of up to 50% of his annual base salary, payable at the discretion of the Compensation
Committee of the Board. Dr. Campbell was also eligible to receive healthcare benefits as may be provided from time to time by the Company
to its employees generally, and to receive paid time off annually.

 Pursuant to the Campbell Employment Agreement,
Dr. Campbell was granted a long-term equity incentive grant in the form of an option to purchase 3% of the total outstanding shares of
the Company's common stock as of the Effective Date. Such award vests in quarterly increments over a period of three years from
the Effective Date, subject to Dr. Campbell's continued employment by the Company on the applicable vesting date. Dr. Campbell's
option grant has an exercise price per share equal to $0.4305, which was the closing price of the Company's common stock on Nasdaq
on the grant date.

 Pursuant to the Campbell Employment Agreement,
Dr. Campbell agreed to be bound by certain non-compete and non-solicitation covenants contained therein.

 Effective as of January 10, 2024, Dr. Campbell resigned as President
and Chief Executive Officer and a member of the Board. The Company entered into a Release of Claims with Dr. Campbell, pursuant to which
Dr. Campbell will receive a severance payment of $158,333 in two equal payments.

 Bruce Harmon

 In connection with Mr. Harmon's appointment,
the Company and Mr. Harmon entered into an employment agreement (the "Harmon Employment Agreement"), pursuant to which Mr.
Harmon will serve as Chief Financial Officer of the Company and will be paid an annual base salary of $325,000. In addition, Mr. Harmon
is entitled to receive, subject to employment by the Company on the applicable date of bonus payout, an annual target discretionary bonus
of up to 30% of his annual base salary, payable at the discretion of the Compensation Committee of the Board. Pursuant to the Harmon Employment
Agreement, Mr. Harmon is also eligible to receive healthcare benefits as may be provided from time to time by the Company to its employees
generally, and to receive paid time off annually.

 Pursuant to the Harmon Employment Agreement, Mr.
Harmon was granted a long-term equity incentive grant in the form of an option to purchase 1% of the total outstanding shares of the Company's
common stock as of the Effective Date. Such award vests in quarterly increments over a period of three years from the Effective Date,
subject to Mr. Harmon's continued employment by the Company on the applicable vesting date. Mr. Harmon's option grant has
an exercise price per share equal to $0.4305, which was the closing price of the Company's common stock on the Nasdaq Stock Market
on the grant date.

 Pursuant to the Harmon Employment Agreement, Mr.
Harmon agreed to be bound by certain non-compete and non-solicitation covenants contained therein.

 Mr. Harmon resigned as Chief Financial Officer
of the Company effective as of June 8, 2024. On June 10, 2024, the Company entered into a Release Agreement with Mr. Harmon, which provides
for two months of severance payment.

 Christian Br hlmann

 In November 2011, Christian Br hlmann entered
into an employment agreement with Proteomedix (as amended, the "Br hlmann Employment Agreement"), pursuant to which Mr.
Br hlmann serves as Chief Financial Officer of Proteomedix and was paid a base salary of 233,100 Swiss francs ("CHF")
in the fiscal year ended December 31, 2024. Mr. Br hlmann is also eligible to participate in the stock option plan sponsored by Proteomedix
(the "PMX Option Plan") and to receive accident insurance, sick pay insurance, a pension plan, and certain government-mandated
child allowance benefits.

 Pursuant to the Br hlmann Employment Agreement,
Mr. Br hlmann agreed to be bound by certain non-compete and non-solicitation covenants contained therein.

 The Br hlmann Employment Agreement may be
terminated with notice in writing by either Proteomedix or Mr. Br hlmann. In the event of a change of control, either party must
give twelve months' notice, but for a period starting six months prior to and two years after a change of control becomes effective,
Proteomedix must, upon request of Mr. Br hlmann, release him from his working obligations ("Garden Leave") within 30
days after receipt of such request. During the Garden Leave, Mr. Br hlmann may enter into consulting arrangements and accept board
positions, provided that Mr. Br hlmann' statutory and contractual confidentiality, non-competition and non-solicitation obligations
remain unchanged and in effect. If the termination of the Br hlmann Employment Agreement is for any other reason than a change of
control, then either party must give five months' notice.

 On February 18, 2025, Christian Br hlmann
resigned from his position as Chief Strategy Officer of the Company, effective immediately. Mr. Br hlmann will remain in his position
as Chief Business Officer of Proteomedix AG.

 Ralph Schiess

 In November 2011, Ralph Schiess entered into an
employment agreement with Proteomedix (as amended, the "Schiess Employment Agreement"), pursuant to which Dr. Schiess serves
as Chief Executive Officer of Proteomedix and was paid a base salary of CHF 233,100 in the fiscal year ended December 31, 2023. Dr. Schiess
is also eligible to participate in the PMX Option Plan and to receive accident insurance, sick pay insurance, a pension plan, and certain
government-mandated child allowance benefits. Dr. Schiess received a bonus of CHF 90,804 for 2023.

 Pursuant to the Schiess Employment Agreement,
Dr. Schiess agreed to be bound by certain non-compete and non-solicitation covenants contained therein.

 The Schiess Employment Agreement may be terminated
with notice in writing by either Proteomedix or Dr. Schiess. In the event of a change of control, either party must give twelve months'
notice, but for a period starting six months prior to and two years after a change of control becomes effective, Proteomedix must, upon
request of Dr. Schiess, must provide Garden Leave within 30 days after receipt of such request. During the Garden Leave, Dr. Schiess may
enter into consulting arrangements and accept board positions, provided that Dr. Schiess' statutory and contractual confidentiality,
non-competition and non-solicitation obligations remain unchanged and in effect. If the termination of the Schiess Employment Agreement
is for any other reason than a change of control, then either party must give five months' notice.

 On February 24, 2025, Dr. Schiess resigned from
his positions as the Interim Chief Executive Officer and Chief Science Officer of the Company, effective immediately, and from his position
as Chief Executive Officer of Proteomedix, effective May 31, 2025.

 On June 10, 2024, the Company appointed Karina
M. Fedasz as Interim Chief Financial Officer of the Company, effective immediately. In connection with Ms. Fedasz's appointment
as Interim Chief Financial Officer, on June 10, 2024, the Company and Ms. Fedasz entered into a consulting agreement (the "Fedasz
Consulting Agreement"), pursuant to which Ms. Fedasz will serve as Interim Chief Financial Officer of the Company and will be paid
$15,000 per month for up to 80 hours of monthly service to the Company and will provide signatory services for $2,500 per month. The Fedasz
Consulting Agreement is for a term of one year, subject to early termination by either party upon thirty (30) days' written notice.

 On April 2, 2025, Ms. Fedasz was appointed Interim
Chief Executive Officer of the Company. No additional compensation was granted in connection with this appointment.

 Potential Payments Upon Termination or Change-in-Control

 See "Employment Agreements of Named Executive Officers"
above.

 Outstanding Equity Awards at Fiscal Year-End

 None of our named executive officers had any outstanding equity incentive
plan awards as of December 31, 2024.

 Director Compensation

 The Board has approved cash and equity compensation
of directors, such that we pay each of our non-employee directors an annual cash retainer for service on the Board and for service on
each committee on which the director is a member. The chair of each committee receives an additional annual retainer for such service.
All retainers are payable in arrears in four equal quarterly installments. The retainers paid to non-employee directors for service on
the Board and for service on each committee of the Board on which the director is a member are as follows:

 Annual Board Service Retainer

 All non-employee directors

 $
 45,000

 Annual Committee Member Service Retainer

 Member of the Audit Committee

 $
 10,000

 Member of the Compensation Committee

 $
 7,500

 Member of the Nominating and Corporate Governance Committee

 $
 5,000

 Annual Committee Chair Service Retainer

 (in addition to Committee Member Service Retainer above):

 Chair of the Audit Committee

 $
 15,000

 Chair of the Compensation Committee

 $
 7,500

 Chair of the Nominating and Corporate Governance Committee

 $
 5,000

 Certain members of our Board have voluntarily
elected to waive payment of their annual cash retainers.

 Additionally, each non-director will receive an
annual grant of restricted stock awards equal to 0.04% of the shares of Common Stock outstanding as of the date of the Company's
annual meeting, such restricted stock vesting approximately one year from the grant dates and upon the director's death or disability
or upon a change of control of the Company.

 Our Compensation Committee will continue to review
and make recommendations to the Board regarding compensation of directors, including equity-based plans. We will reimburse our non-employee
directors for reasonable travel expenses incurred in attending board and committee meetings.

 Director Compensation Table

 The following table sets forth information concerning
the compensation of our directors for the year ended December 31, 2024:

 Fees
 Earned or
 Paid In
 Cash

 Stock
 Awards

 Option
 Awards

 All Other
 Compensation

 Total

 Name

 ($)

 ($) (1)

 ($) (1)

 ($)

 ($)

 Thomas Meier

 11,250
 (2,4)

 5,120
 (3)

 —

 40,067
 (4)

 56,437

 Timothy Ramdeen

 72,500
 (5)

 5,120
 (3)

 —

 —

 77,620

 James Sapirstein (9)

 176,250
 (6)

 5,120
 (3)

 —

 —

 181,370

 Ajit Singh

 45,000
 (2)

 5,120
 (7)

 —

 —

 50,120

 Simon Tarsh

 82,500
 (8)

 5,120
 (3)

 —

 —

 87,620

 (1)

 This figure represents the aggregate grant date fair value of stock-based awards granted in the fiscal year, computed in accordance with the provisions of FASB ASC 718. Assumptions used in the calculation of these amounts are included in the notes to our consolidated financial statements included elsewhere in this Report.

 (2)

 Represents fees earned for serving as a member of the Board.

 (3)

 These directors were each granted 3,318 shares of restricted stock on September 26, 2024, which vest on August 31, 2025. All such shares are unvested and remain outstanding as of December 31, 2024.

 (4)

 Represents fees earned for serving as a seller's representative in connection with the PMX merger.

 (5)

 Represents fees earned by Mr. Ramdeen, for serving as a member of the Board, Audit Committee, and Compensation Committee, as well as Chairman of the Nominating Governance Committee totaling $72,500.

 (6)

 Represents fees earned by Mr. Sapirstein, for serving as a member of the Board, Audit Committee, and Nominating Governance Committee, as well as Chairman of the Compensation Committee, totaling $75,000. This figure also includes $101,250 of fees earned by Mr. Sapirstein for his role as Lead Independent Director and non-executive Chairman of the Board.

 (7)

 Mr. Singh was granted 3,318 shares of restricted stock, which vest on August 31, 2025. All such shares are unvested and remain outstanding as of December 31, 2024. Mr. Sing was also granted 78 shares on February 14, 2024 when he joined the Board, which vested in full on June 30, 2024.

 (8)

 Represents fees earned by Mr. Tarsh for serving as a member of the Board, Compensation Committee, and Nominating Governance Committee, as well as Chairman of the Audit Committee, totaling $82,500.

 (9)

 As of March 28, 2025, James Sapirstein resigned as Executive Chairman and a member of the Board.

 Securities Authorized for Issuance under
Equity Compensation Plans

 The following table provides information as of
December 31, 2024, regarding our common stock that may be issued under the Company's 2019 Equity Incentive Plan (the "2019
Plan") and the Company's 2022 Equity Incentive Plan (the "2022 Plan").

 Plan category:

Securities to

be issued

Upon

Exercise of

Outstanding

Options,

Warrants,

and Rights (a)

Exercise

Price of

Outstanding

Options (b)

Securities

Remaining

Available for

Future

Issuance

Under Equity

Compensation

Plans

(Excluding

Securities

Reflected in

column (a)) (c)

 Equity compensation plans approved by stockholders

 2019 Plan (1)

 -

 -

 -

 (1)(2)

 2022 Plan (3)

 13,674

 $

 156.96

 719,660

 Total

 13,674

 $

 156.96

 719,660

 (1)

 The 2019 Plan permits grants of equity awards to employees, directors, consultants, and other independent contractors. Our board of directors and stockholders have approved a total reserve of 35,000 shares for issuance under the 2019 Plan.

 (2)

 Once the 2022 Plan became effective, no further grants were made under the 2019 Plan and all shares that remained available for the issuance of awards under our 2019 Plan as of immediately prior to the time our 2022 Plan became effective were rolled over into the 2022 Plan.

 (3)

 The 2022 Plan permits grants of equity awards to employees, directors, consultants, and other independent contractors. Our board of directors and stockholders have approved a total reserve of 1,450,000 shares for issuance under the 2022 Plan, of which 719,660 are remaining.

 The following table provides
information as of December 31, 2024, regarding common stock of Proteomedix that may be issued under a stock option plan sponsored by Proteomedix
(the "PMX Option Plan").

 Plan category:

 Securities to
 be issued
 Upon
 Exercise of
 Outstanding
 Options
 (a)

 Exercise
 Price of
 Outstanding
 Options (b)

 Securities
 Remaining
 Available for
 Future
 Issuance
 Under Equity
 Compensation
 Plans
 (Excluding
 Securities
 Reflected in
 column (a)) (c)

 Equity compensation plans approved by Proteomedix board of directors

 PMX Option Plan (1)

 58,172

 3.46

 n/a
 (1)(2)

 Total

 58,172

 3.46

 (1)

 The PMX Option Plan permits grants of equity awards to employees and consultants. The board of directors of Proteomedix approves shares issued under this plan and there is no maximum number of shares that may be issued.

 (2)

 The PMX Option Plan does not have a maximum number of shares that may be issued.

 2022 Equity Incentive Plan

 Our board of directors adopted, and our stockholders
approved, our 2022 Plan effective upon the completion of our initial public offering. Our 2022 Plan is a successor to and continuation
of our 2019 Plan. Our 2022 Plan became effective on the date of the completion of our initial public offering. Once the 2022 Plan became
effective, no further grants will be made under the 2019 Plan.

 Awards. Our 2022 Plan provides for the
grant of incentive stock options, or ISOs, within the meaning of Section 422 of the Internal Revenue Code, or the Code, to employees,
including employees of any parent or subsidiary, and for the grant of nonstatutory stock options, or NSOs, stock appreciation rights,
restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and consultants,
including employees and consultants of our affiliates.

 Authorized Shares. Initially, the maximum
number of shares of our common stock that may be issued under our 2022 Plan was 40,000 shares of our common stock, which is the sum of
(i) 5,000 new shares, plus (ii) an additional number of shares not to exceed 35,000 (calculated after giving effect to the Pre-IPO Stock
Split), consisting of (A) shares that remain available for the issuance of awards under our 2019 Plan as of immediately prior to the time
our 2022 Plan becomes effective and (B) shares of our common stock subject to outstanding stock options or other stock awards granted
under our 2019 Plan that, on or after the 2022 Plan becomes effective, terminate or expire prior to exercise or settlement; are not issued
because the award is settled in cash; are forfeited because of the failure to vest; or are reacquired or withheld (or not issued) to satisfy
a tax withholding obligation or the purchase or exercise price, if any, as such shares become available from time to time.

 On August 22, 2022, at the Company's 2022
annual meeting of stockholders, the Company's stockholders approved an additional 25,000 shares of common stock that may be issued
under the 2022 Plan. On May 31, 2023, at the Company's 2022 annual meeting of stockholders, the Company's stockholders approved
an additional 13,750 shares of common stock that may be issued under the 2022 Plan. On September 5, 2024, at the Company's 2024
annual meeting of stockholders, the Company's stockholders approved an additional 1,371,250 shares of common stock that may be issued
under the 2022 Plan.

 The number of shares of common stock available
for issuance under our 2022 Plan will be reduced by: one share for each share of common stock issued pursuant to a stock option or stock
appreciation right with respect to which the exercise or strike price is at least 100% of the Fair Market Value of the Common Stock subject
to the stock option or appreciation right on the grant date; and (ii) 1.20 shares for each share of common stock issued pursuant to any
restricted stock unit or other "full value award." The maximum number of shares of our common stock that may be issued on
the exercise of ISOs under our 2022 Plan is equal to the number of shares reserved under the 2022 Plan at any time.

 Shares subject to stock awards granted under our
2022 Plan that expire or terminate without being exercised in full or that are paid out in cash rather than in shares do not reduce the
number of shares available for issuance under our 2022 Plan. Shares withheld under a stock award to satisfy the exercise, strike, or purchase
price of a stock award or to satisfy a tax withholding obligation do not reduce the number of shares available for issuance under our
2022 Plan. If any shares of our common stock issued pursuant to a stock award are forfeited back to or repurchased or reacquired by us
(i) because of a failure to meet a contingency or condition required for the vesting of such shares, (ii) to satisfy the exercise, strike
or purchase price of an award or (iii) to satisfy a tax withholding obligation in connection with an award, the shares that are forfeited
or repurchased or reacquired will revert to and again become available for issuance under the 2022 Plan. Any shares previously issued
which are reacquired in satisfaction of tax withholding obligations or as consideration for the exercise or purchase price of a stock
award will again become available for issuance under the 2022 Plan. The number of shares available for issuance under our 2022 Plan will
increase by 1.20 shares for each share subject to restricted stock units or other full value awards (not including stock options or stock
appreciation rights) which are forfeited or reacquired for the reasons described in the preceding two sentences.

 Plan Administration. Our Board of Directors
has assigned the authority to administer the 2022 Plan to our Compensation Committee, but may, at any time, re-vest in itself some or
all of the power delegated to our Compensation Committee. The Compensation Committee may delegate to one or more of our officers the authority
to (i) designate employees (other than officers) to receive specified stock awards and (ii) determine the number of shares subject to
such stock awards. Under our 2022 Plan, our Compensation Committee has the authority to determine award recipients, grant dates, the numbers
and types of stock awards to be granted, the applicable fair market value, and the provisions of each stock award, including the period
of exercisability and the vesting schedule applicable to a stock award.

 Stock Options. ISOs and NSOs are granted
under stock option agreements in a form approved by the Compensation Committee. The Compensation Committee determines the exercise price
for stock options, within the terms and conditions of the 2022 Plan, provided that the exercise price of a stock option generally cannot
be less than 100% of the fair market value of our common stock on the date of grant. Options granted under the 2022 Plan vest at the rate
specified in the stock option agreement as determined by the Compensation Committee.

 The Compensation Committee determines the term
of stock options granted under the 2022 Plan, up to a maximum of 10 years. Unless the terms of an option holder's stock option agreement,
or other written agreement between us and the recipient approved by the Compensation Committee, provide otherwise, if an option holder's
service relationship with us or any of our affiliates ceases for any reason other than disability, death or cause, the option holder may
generally exercise any vested options for a period of three months following the cessation of service. This period may be extended in
the event that exercise of the option is prohibited by applicable securities laws. If an option holder's service relationship with
us or any of our affiliates ceases due to death, or an option holder dies within a certain period following cessation of service, the
option holder or a beneficiary may generally exercise any vested options for a period of 18 months following the date of death. If an
option holder's service relationship with us or any of our affiliates ceases due to disability, the option holder may generally
exercise any vested options for a period of 12 months following the cessation of service. In the event of a termination for cause, options
generally terminate upon the termination date. In no event may an option be exercised beyond the expiration of its term.

 Acceptable consideration for the purchase of common
stock issued upon the exercise of a stock option will be determined by the Compensation Committee and may include (i) cash, check, bank
draft or money order, (ii) a broker-assisted cashless exercise, (iii) the tender of shares of our common stock previously owned by the
option holder, (iv) a net exercise of the option if it is an NSO or (v) other legal consideration approved by the Board of Directors.

 Unless the Compensation Committee provides otherwise,
options or stock appreciation rights generally are not transferable except by will or the laws of descent and distribution. Subject to
approval of the Compensation Committee or a duly authorized officer, an option may be transferred pursuant to a domestic relations order,
official marital settlement agreement or other divorce or separation instrument.

 Tax Limitations on ISOs. The aggregate
fair market value, determined at the time of grant, of our common stock with respect to ISOs that are exercisable for the first time by
an award holder during any calendar year under all of our stock plans may not exceed $100,000. Options or portions thereof that exceed
such limit will generally be treated as NSOs. No ISO may be granted to any person who, at the time of the grant, owns or is deemed to
own stock possessing more than 10% of our total combined voting power or that of any of our parent or subsidiary corporations unless (i)
the option exercise price is at least 110% of the fair market value of the stock subject to the option on the date of grant and (ii) the
term of the ISO does not exceed five years from the date of grant.

 Restricted Stock Unit Awards. Restricted
stock unit awards are granted under restricted stock unit award agreements in a form approved by the Compensation Committee. Restricted
stock unit awards may be granted in consideration for any form of legal consideration that may be acceptable to our board of directors
and permissible under applicable law. A restricted stock unit award may be settled by cash, delivery of stock, a combination of cash and
stock as deemed appropriate by the Compensation Committee or in any other form of consideration set forth in the restricted stock unit
award agreement. Additionally, dividend equivalents may be credited in respect of shares covered by a restricted stock unit award. Except
as otherwise provided in the applicable award agreement, or other written agreement between us and the recipient approved by the Compensation
Committee, restricted stock unit awards that have not vested will be forfeited once the participant's continuous service ends for
any reason.

 Restricted Stock Awards. Restricted stock
awards are granted under restricted stock award agreements in a form approved by the Compensation Committee. A restricted stock award
may be awarded in consideration for cash, check, bank draft or money order, past or future services to us or any other form of legal consideration
that may be acceptable to our board of directors and permissible under applicable law. The Compensation Committee determines the terms
and conditions of restricted stock awards, including vesting and forfeiture terms. If a participant's service relationship with
us ends for any reason, we may receive any or all of the shares of common stock held by the participant that have not vested as of the
date the participant terminates service with us through a forfeiture condition or a repurchase right.

 Stock Appreciation Rights. Stock appreciation
rights are granted under stock appreciation right agreements in a form approved by the Compensation Committee. The Compensation Committee
determines the strike price for a stock appreciation right, which generally cannot be less than 100% of the fair market value of our common
stock on the date of grant. A stock appreciation right granted under the 2022 Plan vests at the rate specified in the stock appreciation
right agreement as determined by the Compensation Committee. Stock appreciation rights may be settled in cash or shares of common stock
or in any other form of payment as determined by the Board and specified in the stock appreciation right agreement.

 The Compensation Committee determines the term
of stock appreciation rights granted under the 2022 Plan, up to a maximum of 10 years. If a participant's service relationship with
us or any of our affiliates ceases for any reason other than cause, disability or death, the participant may generally exercise any vested
stock appreciation right for a period of three months following the cessation of service. This period may be further extended in the event
that exercise of the stock appreciation right following such a termination of service is prohibited by applicable securities laws. If
a participant's service relationship with us, or any of our affiliates, ceases due to disability or death, or a participant dies
within a certain period following cessation of service, the participant or a beneficiary may generally exercise any vested stock appreciation
right for a period of 12 months in the event of disability and 18 months in the event of death. In the event of a termination for cause,
stock appreciation rights generally terminate immediately upon the occurrence of the event giving rise to the termination of the individual
for cause. In no event may a stock appreciation right be exercised beyond the expiration of its term.

 Performance Awards. The 2022 Plan permits
the grant of performance awards that may be settled in stock, cash, or other property. Performance awards may be structured so that the
stock or cash will be issued or paid only following the achievement of certain pre-established performance goals during a designated performance
period. Performance awards that are settled in cash or other property are not required to be valued in whole or in part by reference to,
or otherwise based on, the common stock.

 The performance goals may be based on any measure
of performance selected by the board of directors or the Compensation Committee. The performance goals may be based on company-wide performance
or performance of one or more business units, divisions, affiliates, or business segments, and may be either absolute or relative to the
performance of one or more comparable companies or the performance of one or more relevant indices. Unless specified otherwise by the
board of directors at the time the performance award is granted, the board or Compensation Committee will appropriately make adjustments
in the method of calculating the attainment of performance goals as follows: (i) to exclude restructuring and/or other nonrecurring charges;
(ii) to exclude exchange rate effects; (iii) to exclude the effects of changes to generally accepted accounting principles; (iv) to exclude
the effects of any statutory adjustments to corporate tax rates; (v) to exclude the effects of items that are "unusual" in
nature or occur "infrequently" as determined under generally accepted accounting principles; (vi) to exclude the dilutive
effects of acquisitions or joint ventures; (vii) to assume that any portion of our business which is divested achieved performance objectives
at targeted levels during the balance of a performance period following such divestiture; (viii) to exclude the effect of any change in
the outstanding shares of our common stock by reason of any stock dividend or split, stock repurchase, reorganization, recapitalization,
merger, consolidation, spin-off, combination or exchange of shares or other similar corporate change or any distributions to common stockholders
other than regular cash dividends; (ix) to exclude the effects of stock based compensation and the award of bonuses under our bonus plans;
(x) to exclude costs incurred in connection with potential acquisitions or divestitures that are required to be expensed under generally
accepted accounting principles; (xi) to exclude the goodwill and intangible asset impairment charges that are required to be recorded
under generally accepted accounting principles; and (xi) to exclude the effects of the timing of acceptance for review and/or approval
of submissions to the U.S. Food and Drug Administration or any other regulatory body.

 Other Stock Awards. The Compensation Committee
may grant other awards based in whole or in part by reference to our common stock. The Compensation Committee will set the number of shares
under the stock award (or cash equivalent) and all other terms and conditions of such awards.

 Non-Employee Director Compensation Limit. The
aggregate value of all compensation granted or paid to any non-employee director with respect to any calendar year, including awards granted
and cash fees paid by us to such non-employee director, will not exceed $150,000 in total value; provided that such amount will increase
to $200,000 for the first year for newly appointed or elected non-employee directors.

 Changes to Capital Structure. In the event
there is a specified type of change in our capital structure, such as a stock split, reverse stock split or recapitalization, appropriate
adjustments will be made to (i) the class and maximum number of shares reserved for issuance under the 2022 Plan, (ii) the class and maximum
number of shares by which the share reserve may increase automatically each year, (iii) the class and maximum number of shares that may
be issued on the exercise of ISOs and (iv) the class and number of shares and exercise price, strike price or purchase price, if applicable,
of all outstanding stock awards.

 Corporate Transactions. The following applies
to stock awards under the 2022 Plan in the event of a corporate transaction (as defined in the 2022 Plan), unless otherwise provided in
a participant's stock award agreement or other written agreement with us or one of our affiliates or unless otherwise expressly
provided by the Board or Compensation Committee at the time of grant.

 In the event of a corporate transaction, any stock
awards outstanding under the 2022 Plan may be assumed, continued, or substituted for by any surviving or acquiring corporation (or its
parent company), and any reacquisition or repurchase rights held by us with respect to the stock award may be assigned to the successor
(or its parent company). If the surviving or acquiring corporation (or its parent company) does not assume, continue or substitute for
such stock awards, then (i) with respect to any such stock awards that are held by participants whose continuous service has not terminated
prior to the effective time of the corporate transaction, or current participants, the vesting (and exercisability, if applicable) of
such stock awards will be accelerated in full to a date prior to the effective time of the corporate transaction (contingent upon the
effectiveness of the corporate transaction), and such stock awards will terminate if not exercised (if applicable) at or prior to the
effective time of the corporate transaction, and any reacquisition or repurchase rights held by us with respect to such stock awards will
lapse (contingent upon the effectiveness of the corporate transaction), and (ii) any such stock awards that are held by persons other
than current participants will terminate if not exercised (if applicable) prior to the effective time of the corporate transaction, except
that any reacquisition or repurchase rights held by us with respect to such stock awards will not terminate and may continue to be exercised
notwithstanding the corporate transaction.

 In the event a stock award will terminate if not
exercised prior to the effective time of a corporate transaction, the board of directors may provide, in its sole discretion, that the
holder of such stock award may not exercise such stock award but instead will receive a payment equal in value to the excess (if any)
of (i) the per share amount payable to holders of common stock in connection with the corporate transaction over (ii) any per share exercise
price payable by such holder, if applicable. In addition, any escrow, holdback, earn out or similar provisions in the definitive agreement
for the corporate transaction may apply to such payment to the same extent and in the same manner as such provisions apply to the holders
of common stock.

 Plan Amendment or Termination. Our board
of directors has the authority to amend, suspend or terminate our 2022 Plan, provided that such action does not materially impair the
existing rights of any participant without such participant's written consent. Certain material amendments also require the approval
of our stockholders. No ISOs may be granted after the tenth anniversary of the date our board of directors adopts our 2022 Plan. No stock
awards may be granted under our 2022 Plan while it is suspended or after it is terminated.

 2019 Equity Incentive Plan

 Our board of directors adopted, and our stockholders
approved our 2019 Equity Incentive Plan (the "2019 Plan") in July 2019 for grants of awards to employees, directors, officers,
and consultants of us or any of our subsidiaries. Once the 2022 Plan became effective, no further grants will be made under the 2019 Plan.
However, the 2019 Plan will continue to govern the terms and conditions of the outstanding awards previously granted under the 2019 Plan.

 Awards. Our 2019 Plan provides for the
grant of stock awards (collectively, "Stock Awards") to employees, directors, officers and consultants of us or any of our
subsidiaries, consisting of (i) incentive stock options, ("ISOs"), within the meaning of Section 422 of the Internal Revenue
Code (the "Code"); (ii) nonstatutory stock options ("NSOs"); (iii) stock appreciation rights; (iv) restricted
stock awards; (v) restricted stock unit awards, and (vi) other forms of awards.

 Authorized Shares. Once the 2022 Plan became
effective, no further grants were made under the 2019 Plan and all shares that remained available for the issuance of awards under our
2019 Plan as of immediately prior to the time our 2022 Plan became effective were rolled over into the 2022 Plan.

 Plan Administration. The 2019 Plan may
be administered by our board of directors, and our board of directors may delegate such administration to a committee of the board of
directors (as applicable, the "Administrator"). The Administrator, in its discretion, selects the individuals to whom awards
may be granted, the time or times at which such awards are granted and the terms and conditions of such awards.

 Stock Options. Stock options entitle the
holder to purchase a specified number of shares of common stock at a specified price (the exercise price), subject to the terms and conditions
of the stock option grant. Our board of directors may grant either incentive stock options, which must comply with Code Section 422, or
non-qualified stock options. ISO's may only be granted to employees of the Company or a "parent corporation" or "subsidiary
corporation" thereof (as such terms are defined in Sections 424(e) and 424(f) of the Code). Our Administrator sets exercise prices
and terms and conditions; except that stock options must be granted with an exercise price not less than 100% of the fair market value
of our common stock on the date of grant. Unless our Administrator determines otherwise, fair market value means, as of a given date,
the closing price of our common stock. At the time of grant, our board of directors determines the terms and conditions of stock options,
including the quantity, exercise price, vesting periods, term (which may not exceed 10 years) and other conditions on exercise. Pursuant
to the 2019 Plan, we may only issue 35,000 ISOs.

 Eligibility. Awards may be granted under the 2019 Plan to officers,
employees, directors, officers and of us and our subsidiaries. Incentive stock options may be granted only to employees of us or our subsidiaries.

 Restricted Stock, Restricted Stock Units and Other
Stock-Based Awards. Our board of directors may grant awards of restricted stock, which are shares of common stock subject to specified
restrictions, and restricted stock units, or RSUs, which represent the right to receive shares of our common stock in the future. These
awards may be made subject to repurchase, forfeiture or vesting restrictions at the discretion of our board of directors' discretion.
The restrictions may be based on continuous service with us or the attainment of specified performance goals, as determined by the board
of directors. Stock units may be paid in stock or cash or a combination of stock and cash, as determined by the board of directors. Other
stock awards valued in whole or in part by reference to, or otherwise based on, Common Stock, including the appreciation in value thereof
(e.g., options or stock rights with an exercise price or strike price less than one hundred percent (100%) of the fair market value of
the common stock at the time of grant) may be granted either alone or in addition to stock awards provided for under the 2019 Plan.

 Stock Appreciation Rights. Upon exercise,
SARs entitle the holder to receive payment per share in stock or cash, or in a combination of stock and cash, equal to the excess of the
share's fair market value on the date of exercise over the aggregate strike price of the number of Common Stock equivalents with
respect to which the Participant is exercising the SAR on such date (the "grant price". Exercise of a SAR issued in tandem
with a stock option will reduce the number of shares underlying the related stock option to the extent of the SAR exercised. The term
of a SAR cannot exceed 10 years.

 Changes to Capital Structure. In the event
there is a specified type of change in our capital structure, such as a stock split, reverse stock split or recapitalization, appropriate
adjustments will be made to (i) the class and maximum number of shares subject to the 2019 Plan, (ii) the class and maximum number of
shares that may be issued on the exercise of ISOs and (iii) the class and number of shares and exercise price, strike price or purchase
price, if applicable, of all outstanding stock awards.

 Corporate Transactions. The following applies
to Stock Awards under the 2019 Plan in the event of a corporate transaction (as defined in the 2019 Plan), unless otherwise provided in
a participant's stock award agreement or other written agreement with us or one of our affiliates or unless otherwise expressly
provided by the Board at the time of grant.

 In the event of a corporate transaction, the board
of directors may take one of the following actions, contingent on the completion of the corporate transaction: (i) arrange for the surviving
or acquiring corporation (or its parent company) to assume, continue or substitute the Stock Award for a similar stock award; (ii) arrange
for the assignment of any reacquisition or repurchase rights held by the Company in respect of common stock issued pursuant to the Stock
Award to the surviving or acquiring corporation (or its parent company); (iii) accelerate the vesting (in whole or in part) of the Stock
Award; (iv) arrange for the lapse, in whole or in part, of any reacquisition or repurchase rights held by the Company with respect to
the Stock Award; (v) cancel or arrange for the cancellation of the Stock Award, to the extent not vested or not exercised prior to the
effective time of the corporate transaction, in exchange for such cash consideration that the Board; and (vi) make a payment equal to
the excess, if any, of (A) the value of the property the participant would have received upon the exercise of the Stock Award immediately
prior to the effective time of the corporate transaction, over (B) any exercise price payable by such holder in connection with such exercise
The Board need not take the same action or actions with respect to all Stock Awards or portions thereof or with respect to all participants.
The Board may also take different actions with respect to the vested and unvested portions of a Stock Award.

 Additionally, under the 2019 Plan, a Stock Award
may be subject to additional acceleration of vesting and exercisability upon or after a Change in Control (as defined in the 2019 Plan)
as may be provided in the Grant Agreement for such Stock Award or as may be provided in any other written agreement between the participant
and the Company or any of its subsidiaries which may employ the participant, but in the absence of such provision, no such acceleration
will occur.

 Plan Amendment or Termination. Our board
of directors has the authority to amend, suspend or terminate our 2019 Plan, subject to certain conditions, including that such action
does not materially impair the existing rights of any participant without such participant's written consent. Certain material amendments
also require the approval of our stockholders. No ISOs may be granted after the tenth anniversary of the date our board of directors adopted
our 2019 Plan.

 Proteomedix Stock Option Plan

 The PMX Option Plan was approved by Proteomedix's
board of directors as of July 1, 2015, and provides for the grant of options to acquire shares in Proteomedix. The terms of the PMX Option
Plan are described in more detail below.

 The PMX Option Plan is administered by a plan
administrator (one or several persons) elected by Proteomedix's board of directors (the "Proteomedix Board") from time
to time. The plan administrator acts within the guidelines set and approved by Proteomedix's board of directors or a committee thereof
and is authorized to, among others, determine (i) which eligible persons are to receive awards under the PMX Option Plan, (ii) the time
or times when such options grants are to be made, (iii) the nature and the number of options covered by each such grant, (iv) the time
or times at which each option right is to become exercisable, (v) the vesting conditions applicable to the options, (vi) the maximum term
for which the options are to remain outstanding, and (vii) any terms and conditions of the options granted, in each case, subject to the
guidelines set and approved by Proteomedix's board of directors or a committee thereof. Persons eligible to participate in the PMX
Option Plan are employees, members of Proteomedix's board of directors and consultants of Proteomedix or a subsidiary. The plan
administrator determines within the guidelines set and approved by Proteomedix's board of directors or a committee which eligible
persons are to receive rights to acquire options under the PMX Option Plan.

 The number of shares that may be issued under
the PMX Option Plan is determined by the Proteomedix's board of directors. In the event common shares that otherwise would have
been issuable under the PMX Option Plan are withheld by Proteomedix in payment of the exercise price or withholding obligations, such
shares shall remain available for issuance under the PMX Option Plan. In the event that an outstanding award expires or is cancelled,
forfeited or terminated for any reason, the shares allocable to the unexercised or unsettled portion shall remain available for issuance
under the PMX Option Plan.

 A participant may only exercise an option or stock
appreciation right to the extent that the option or stock appreciation right has vested and has not lapsed under the PMX Option Plan.
Unless otherwise determined by Proteomedix's board of directors at the grant date or set forth in the grant notice, an option or
an award in the form of a restricted stock unit or stock appreciation right granted under the PMX Option Plan typically vests as to 25.0%
of the award at the end of the first year following the vesting start date, with the remaining 75.0% of the award vesting monthly over
the 3 years after the first year following the vesting start date.

 If indicated in the grant notice or otherwise
resolved by Proteomedix's board of directors, upon the occurrence of a "Corporate Transaction" (as defined in the PMX
Option Plan), all options (i) shall fully vest and (ii) may be immediately exercised, except if such options are canceled by the plan
administrator in exchange for compensation equivalent to the economic value of the option under the PMX Option Plan.

 Proteomedix has complete and exclusive power and
authority to amend or modify the PMX Option Plan in any or all respects. No such amendment or modification shall, without the consent
of the grantee, adversely affect his/her rights and obligations under the PMX Option Plan.

 Item 12. Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters.

 The following table sets forth certain information
concerning the ownership of our common stock, with respect to: (i) each person, or group of affiliated persons, known to us to be the
beneficial owner of more than five percent of our common stock; (ii) each of our directors; (iii) each of our named executive officers;
and (iv) all of our current directors and executive officers as a group.

 Applicable percentage ownership is based on 44,358,422 shares of common
stock outstanding as of May 30, 2025.

 We have determined beneficial ownership in accordance
with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting
or investment power with respect to such securities. In addition, pursuant to such rules, we deemed outstanding shares of common stock
subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days of May 30, 2025. We did
not deem such shares outstanding, however, for the purpose of computing the percentage ownership of any other person. Except as indicated
by the footnotes below, we believe, based on the information furnished to us, that the beneficial owners named in the table below have
sole voting and investment power with respect to all shares of our common stock that they beneficially own, subject to applicable community
property laws.

 Shares of Common
 Stock Owned

 Name and Address of Beneficial Owner (1)

 Percentage

 Executive Officers and Directors

 James Sapirstein

 3,477
 (10)

 *

 Simon Tarsh

 3,477
 (2)

 *

 Timothy Ramdeen

 3,477
 (3)

 *

 Thomas Meier

 3,318
 (4)

 *

 Ajit Singh

 3,396
 (5)

 *

 Karina M. Fedasz

 -

 -

 Ralph Schiess

 673,365
 (6)

 1.5
 %

 Christian Br hlmann

 611,372
 (7)

 1.4
 %

 Bruce Harmon

 29,574
 (8)

 *

 Neil Campbell

 -
 (9)

 *

 Andrew Oakley

 1,709
 (11)

 All directors and named executive officers as a group (11 persons)

 1,333,165

 %

 5% Stockholders

 Altos Venture AG

 2,695,931
 (12)

 %

 *

 Represents beneficial ownership of less than 1%.

 (1)

 Unless otherwise noted, the business address of each of the following entities or individuals is c/o Onconetix, Inc., 201 E. Fifth Street, Suite 1900, Cincinnati, Ohio 45202.

 (2)

 Includes 3,477 restricted stock awards of which 3,318 do not vest until August 31, 2025 and 101 shares of common stock underlying options that are currently exercisable within 60 days of November 1, 2024.

 (3)

 Includes 3,477 restricted stock awards of which 3,318 do not vest until August 31, 2025 and 59 shares of common stock underlying options that are currently exercisable within 60 days of November 1, 2024.

 (4)

 Includes 3,318 restricted stock awards of which 3,318 do not vest until August 31, 2025.

 (5)

 Includes 3,396 restricted stock awards of which 3,318 do not vest until August 31, 2025.

 (6)

 Includes 177,462 shares of common stock issuable upon settlement of RSUs. Dr. Schiess resigned as Chief Science Officer and Interim Chief Executive Officer on February 24, 2025.

 (7)

 Includes 177,462 shares of common stock issuable upon settlement of RSUs. Mr. Br hlmann resigned as Chief Strategy Officer on February 18, 2025.

 (8)

 Consists of 29,574 shares of common stock. Mr. Harmon resigned as Chief Financial Officer on June 8, 2024.

 (9)

 Mr. Campbell resigned as Chief Executive Officer on January 10, 2024.

 (10)

 Consists of 3,477 shares of common stock underlying options that are currently exercisable within 60 days of April 5, 2024.

 (11)

 Includes 1,709 restricted stock awards of which 1,709 do not vest until August 31, 2025.

 (12)

 Per Schedule 13D filed on September 26, 2024, Altos Venture AG ("Altos") is the beneficial owner of 2,695,931 shares of Common Stock. The address of Altos is Obertorweg 64, CH-4123, Allschwil, Switzerland.

 Item 13. Certain Relationships and Related
Transactions, and Director Independence.

 The following is a description of transactions
since January 1, 2023 to which we were a party in which (i) the amount involved exceeded or will exceed the lesser of $120,000 of one
percent (1%) of our average total assets at year-end for the last two completed fiscal years and (ii) any of our directors, executive
officers or holders of more than 5% of our capital stock, or any member of the immediate family of, or person sharing the household with,
any of the foregoing persons, who had or will have a direct or indirect material interest, other than equity and other compensation, termination,
change in control and other similar arrangements, which are described under "Executive and Director Compensation."

 Debenture

 On January 23, 2024, the Company issued a non-convertible
debenture (the "Debenture") in the principal sum of $5.0 million, in connection with a Subscription Agreement, to Altos Ventures,
a stockholder of the Company. The Debenture has an interest rate of 4.0% per annum, and the principal and accrued interest are payable
in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024. Additionally, the $5.0 million subscription
amount under the Subscription Agreement shall be increased by the amount of interest payable under the Debenture.

 Related party advances

 During the year ended December 31, 2023, the Company's
Audit Committee completed a review of the Company's expenses due to certain irregularities identified with regards to the related
party balance. Based on the results of the review, it was determined that the Company paid and recorded within selling, general and administrative
expenses, personal expenditures of the Company's former CEO and an accounting employee who was also the former CEO's assistant,
during 2022 and during the first three quarters of 2023. The Company evaluated the receivable, which was approximately $363,000, after
recording a recovery of approximately $159,000, and which represented the total of the items identified as personal in nature for which
the Company did not anticipate recovery from the related party. During 2023, the Company recorded a corresponding reserve for the full
amount, resulting in a net related party receivable balance of $0 as of December 31, 2023. There were no such transactions during the
year ended December 31, 2024.

 Lease Agreements

 The Company entered into a short-term lease in
Palm Beach, Florida with an unrelated party, with a commencement date of May 1, 2022, for approximately $14,000 per month. The lease,
which was personally guaranteed by the Company's former CEO, ended on April 30, 2023. During the year ended December 31, 2023, the
Company incurred rent expense on this lease of approximately $51,000, and variable lease expense of approximately $4,000.

 Consulting Agreement

 On February 6, 2024,
the Company appointed Thomas Meier, PhD, as a member of the Company's board of directors. Dr. Meier provides consulting services
to Proteomedix, through a consulting agreement that was effective January 4, 2024. The Company recorded approximately $58,000 in related
expenses during the year ended December 31, 2024, of which approximately $11,000 is included in accrued expenses in the accompanying consolidated
financial statements as of December 31, 2024.

 On February 28, 2025, the Company and James Sapirstein
entered into a consulting agreement, pursuant to which Mr. Sapirstein will be compensated on an hourly basis at a rate of $400 per hour
for up to twenty hours per week. As of March 28, 2025, James Sapirstein resigned as Executive Chairman and a member of the Board.

 Director Independence

 The Board has evaluated each of its directors'
independence from the Company based on the definition of "independence" established by Nasdaq and has determined that each
of Simon Tarsh, Timothy Ramdeen, Andrew Oakley and Ajit Singh are independent directors, constituting a majority of the Board. The Board
has further determined that each member of our Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee
is "independent" under applicable Nasdaq rules.

 The Board has also determined that each member
of our audit committee is "independent" for purposes the Exchange Act.

 In its evaluation of each director's or
nominee's independence from the Company, the Board reviewed whether any transactions or relationships currently exist or existed
during the past year between each director or nominee and the Company and its subsidiaries, affiliates, equity investors, or independent
registered public accounting firm, and whether there were any transactions or relationships between each director or nominee and members
of the senior management of the Company or their affiliates.

 Item 14. Principal Accounting Fees and Services.

 Audit and Non-Audit Fees

 EisnerAmper served as the independent registered
public accounting firm to audit our books and accounts for the fiscal year ended December 31, 2023. Malone-Bailey served as the independent
registered public accounting firm to audit our books and accounts for the fiscal year ended December 31, 2024.

 The table below presents the aggregate fees billed
for professional services rendered by Malone-Bailey and EisnerAmper (prior auditor) for the years ended December 31, 2024 and
2023, respectively.

 EiEisnerAmper

 2024

 2023

 Audit fees

 $
 742,827

 $
 951,818

 Audit-related fees

 —

 —

 Tax fees

 —

 —

 All other fees

 —

 —

 Total fees

 $
 742,827

 $
 951,818

 Malone-Bailey

 2024

 2023

 Audit fees

 $
 267,800

 $
 —

 Audit-related fees

 —

 —

 Tax fees

 —

 —

 All other fees

 —

 —

 Total fees

 $
 267,800

 $
 —

 In the above table, "audit
fees" are fees billed for services provided related to the audit of our annual consolidated financial statements, quarterly reviews
of our interim condensed financial statements, and services normally provided by EisnerAmper and Malone-Bailey in connection with regulatory
filings or engagements for that fiscal period.

 Pre-Approval Policy

 It is the Audit Committee's policy to approve
in advance the types and amounts of audit, audit-related, tax, and any other services to be provided by our independent registered public
accounting firm. In situations where it is not practicable to obtain full Audit Committee approval, the Audit Committee has delegated
authority to the Chair of the Audit Committee to grant pre-approval of audit and permissible non-audit services and any associated fees.
Any pre-approved decisions by the Chair are required to be reviewed with the Audit Committee at its next scheduled meeting.

 Our Audit Committee was formed upon the consummation
of our initial public offering. As a result, the audit committee did not pre-approve all of the foregoing services, although any services
rendered prior to the formation of our audit committee were approved by our board of directors. Since the formation of our Audit Committee,
and on a going-forward basis, the Audit Committee has and will pre-approve all auditing services and permitted non-audit services to
be performed for us by our auditors, including the fees and terms thereof (subject to the de minimis exceptions for non-audit services
described in the Exchange Act which are approved by the audit committee prior to the completion of the audit).

 Item 15. Exhibit and Financial Statement Schedules.

 INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

 Page

 Consolidated Financial Statements

 Report of Independent Registered Public Accounting Firm (PCAOB ID 206)

 Report of Independent Registered Public Accounting Firm (PCAOB ID 274)

 Consolidated Balance Sheets as of December 31, 2024 and 2023

 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023

 Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) for the years ended December 31, 2024 and 2023

 Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023

 F- 1

 Report
of Independent Registered Public Accounting Firm

 To the Board of Directors and Stockholders of

 Onconetix, Inc.

 Opinion on the Financial Statements

 We have audited the accompanying consolidated
balance sheet of Onconetix Inc. and its subsidiary (collectively, the "Company") as of December 31, 2024, and the related
consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders' equity (deficit), and
cash flows for the year then ended, and the related notes (collectively referred to as the "financial statements"). In our
opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024,
and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted
in the United States of America.

 Going Concern

 The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has
suffered recurring losses from operations and has a net capital deficiency that raises substantial doubt about its ability to continue
as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include
any adjustments that might result from the outcome of this uncertainty.

 Basis for Opinion

 These financial statements are the responsibility
of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our
audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB")
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.

 We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion.

 Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.

 /s/ MaloneBailey, LLP

 www.malonebailey.com

 We have served as the Company's auditor
since 2025.

 MALONEBAILEY LLP

 Houston, Texas

 May 30, 2025

 F- 2

 Report
of Independent Registered Public Accounting Firm

 To the Board of Directors and Stockholders of

 Onconetix, Inc.

 Opinion on the Financial Statements

 We have audited the accompanying consolidated
balance sheet of Onconetix Inc. and Subsidiary (the "Company") as of December 31, 2023, and the related consolidated statements
of operations and comprehensive loss, convertible preferred stock and stockholders' equity (deficit), and cash flows for the year
then ended, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial
statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023, and the
consolidated results of their operations and their cash flows for the year then ended, in conformity with accounting principles generally
accepted in the United States of America.

 Going Concern

 The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has
incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable
future, which raises substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters
are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 Basis for Opinion

 These financial statements are the responsibility
of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB")
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.

 We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's
internal control over financial reporting. Accordingly, we express no such opinion.

 Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.

 /s/ EisnerAmper LLP

 We served as the Company's auditor from
2023 to 2024.

 EISNERAMPER LLP

 Iselin, New Jersey

 April 11, 2024, except for the effects of the reverse stock split discussed
in Note 1 to the financial statements, as to which the date is May 30, 2025.

 F- 3

Consolidated Balance Sheets

 2024

 2023

 ASSETS

 Current assets

 Cash

 $
 646,500

 $
 4,554,335

 Accounts receivable, net

 25,717

 149,731

 Inventories

 64,079

 364,052

 Prepaid expenses and other current assets

 213,971

 770,153

 Total current assets

 950,267

 5,838,271

 Prepaid expenses, long-term

 -

 17,423

 Deferred offering costs

 -

 366,113

 Property and equipment, net

 62,896

 60,654

 Operating right of use asset

 119,427

 148,542

 Intangible assets, net

 -

 25,410,887

 Goodwill

 27,048,973

 55,676,142

 Total assets

 $
 28,181,563

 $
 87,518,032

 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY

 Current liabilities

 Accounts payable

 $
 3,787,564

 $
 5,295,114

 Accrued expenses

 888,988

 2,199,867

 Notes payable, net of debt discounts of $ 4,966 and $ 381,627 at December 31, 2024 and 2023, respectively

 9,328,061

 9,618,373

 Operating lease liability, current

 119,427

 74,252

 Subscription agreement liability - Related Party

 4,123,000

 -

 Contingent warrant liabilities

 43,089

 2,641

 Total current liabilities

 18,290,129

 17,190,247

 Note payable, net of current portion

 -

 118,857

 Subscription agreement liability, long-term related party

 -

 864,000

 Pension benefit obligation

 280,879

 556,296

 Operating lease liability, net of current portion

 -

 74,290

 Deferred tax liability, net

 -

 3,073,781

 Total liabilities

 18,571,008

 21,877,471

 Commitments and Contingencies (see Note 10)

 Series B Convertible Redeemable Preferred stock, $ 0.00001 par value, 2,700,000 shares authorized at December 31, 2024 and 2023, 0 and 2,696,729 shares issued and outstanding at December 31, 2024 and 2023, respectively

 -

 Series C Redeemable Preferred Stock, $ 0.00001 par value, 10,000 shares authorized, 3,499 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively

 1,067,928

 -

 Stockholders' equity

 Series A Convertible Preferred stock, $ 0.00001 par value, 10,000 shares authorized at December 31, 2024 and 2023; 0 and 3,000 shares issued and outstanding at December 31, 2024 and 2023, respectively; Liquidation preference of $ 0 and $ 3,000,000 at December 31, 2024 and 2023, respectively.

 -

 -

 Common stock, $ 0.00001 par value, 250,000,000 shares authorized at December 31, 2024 and 2023; 11,767,443 and 571,033 the shares issued at December 31, 2024 and 2023, respectively; 11,754,509 and 558,099 shares outstanding at December 31, 2024 and 2023, respectively

 Additional paid-in capital

 127,825,626

 49,429,031

 Treasury stock, at cost; 12,934 shares of common stock at December 31, 2024 and 2023

)

)

 Due from shareholders

 ( 250,308
)

 -

 Accumulated deficit

 ( 115,683,621
)

 ( 56,786,194
)

 Accumulated other comprehensive income (loss)

 ( 2,723,397
)

 2,380,920

 Total Onconetix, Inc. stockholders' equity (deficit)

 8,542,627

 ( 5,602,028
)

 Non-controlling interest

 -

 Total stockholders' equity

 8,542,627

 1,404,476

 Total liabilities, convertible preferred stock, and stockholders' equity

 $
 28,181,563

 $
 87,518,032

 The accompanying notes are an integral part
of these consolidated financial statements.

 F- 4

Consolidated Statements of Operations and Comprehensive Loss

 2024

 2023

 Revenue

 $
 2,524,116

 $

 Cost of revenue

 1,469,018

 1,185,630

 Gross profit

 1,055,098

 ( 1,127,165
)

 Operating expenses

 Selling, general, and administrative

 11,231,982

 14,770,678

 Research and development

 154,359

 1,949,406

 Impairment of ENTADFI

 3,530,716

 14,687,346

 Impairment of intangibles

 10,279,796

 -

 Impairment of goodwill

 32,347,000

 -

 Impairment of deposit on asset purchase agreement

 -

 3,500,000

 Total operating expenses

 57,543,853

 34,907,430

 Loss from operations

 ( 56,488,755
)

 ( 36,034,595
)

 Other (expense) income

 Loss on extinguishment of note payable

 -

 ( 490,000
)

 Interest expense - related party

 ( 534,245
)

 -

 Interest expense

 ( 873,433
)

 ( 671,625
)

 Interest income

 -

 Change in fair value of subscription agreement liability

 ( 3,259,000
)

 ( 134,100
)

 Change in fair value of contingent warrant liabilities

 1,250,466

 ( 91,967
)

 Other

 168,746

 -

 Total other (loss)

 ( 3,247,448
)

 ( 1,387,692
)

 Loss before income taxes

 ( 59,736,203
)

 ( 37,422,287
)

 Income tax benefit

 1,045,180

 12,593

 $
)

 $
)

 Deemed dividend Series C preferred stock

 ( 206,404
)

 -

 Net loss applicable to common stockholders

 ( 58,897,427
)

)

 Net loss per share, basic and diluted

 $
 ( 21.45
)

 $
 ( 87.45
)

 Weighted average number of common shares outstanding, basic and diluted

 2,745,564

 427,784

 Other comprehensive income (loss)

 $
)

 $
)

 ( 5,342,327
)

 2,374,957

 Change in pension benefit obligation

 238,010

 5,963

 Total comprehensive loss

 $
 ( 63,795,340
)

 $
 ( 35,028,774
)

 The accompanying notes are an integral part
of these consolidated financial statements.

 F- 5

 Consolidated Statements of Convertible Preferred
Stock and Stockholders' Equity (Deficit)

 Series
 A Preferred Stock

 Common
 Stock

 Additional

 Paid-in

 Treasury
 Stock

 Accumulated

 Accumulated

 Other
 Comprehensive

 Due
 from

 Total

 Onconetix

 Non-controlling

 Total

 Stockholders'

 Capital

 Deficit

 Income

 Shareholders

 Balance at December 31, 2023

 3,000

 —

 571,033

 $

 49,429,031

 ( 12,934
)

)

 $
 ( 56,786,194
)

 $
 2,380,920

 $
 -

 $
 ( 5,602,028
)

 $
 1,404,476

 Issuance of common stock
 and warrants from exercise of preferred investment options, net of issuance costs

 —

 —

 186,466

 765,027

 —

 —

 —

 —

 —

 765,029

 —

 765,029

 Grant and immediate exercise
 of warrants

 —

 —

 154,027

 6,153

 —

 —

 —

 —

 —

 6,155

 —

 6,155

 Issuance of shares in connection
 with related party subscription agreement

 —

 —

 513,424

 5,134,242

 —

 —

 —

 —

 —

 5,134,247

 —

 5,134,247

 Conversion of Series A Preferred
 Stock to common stock

 ( 3,000
)

 —

 142,749

 ( 1
)

 —

 —

 —

 —

 —

 —

 —

 —

 Conversion of Series B Preferred
 Stock to common stock

 —

 —

 6,741,820

 64,236,018

 —

 —

 —

 —

 —

 —

 Exercise of stock options

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 260,406

 —

 —

 —

 —

 —

 260,406

 178,247

 438,653

 Issuance of restricted common
 stock

 —

 —

 16,668

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 Forfeitures of restricted stock

 —

 —

 ( 312
)

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 Cash in lieu of shares

 —

 —

 ( 227
)

 —

 ( 719
)

 —

 —

 —

 —

 —

 ( 719
)

 —

 ( 719
)

 adjustment

 —

 —

 —

 —

 —

 —

 —

 —

 ( 5,342,327
)

 —

 ( 5,342,327
)

 —

 ( 5,342,327
)

 Issuance of common stock
 in connection with the ELOC

 —

 —

 2,757,933

 935,562

 —

 —

 —

 —

 ( 250,308
)

 685,282

 —

 685,282

 Issuance of restricted common
 stock in exchange in exchange for options

 —

 —

 683,456

 7,184,744

 —

 —

 —

 —

 —

 7,184,751

 ( 7,184,751
)

 —

 Adjustment to redeemable
 Series C preferred Stock

 —

 —

 —

 —

 ( 125,000
)

 —

 —

 ( 206,404
)

 —

 —

 ( 331,404
)

 —

 ( 331,404
)

 Changes in pension benefit
 obligation

 —

 —

 —

 —

 —

 —

 —

 —

 238,010

 —

 238,010

 —

 238,010

 Net
 loss

 —

 —

 —

 —

 —

 —

 —

)

 —

 —

)

 —

)

 Balance
 at December 31, 2024

 —

 —

 11,767,443

 $
 127,825,626

 ( 12,934
)

)

 $
 ( 115,683,621
)

 $
 ( 2,723,397
)

 $
 ( 250,308
)

 $
 8,542,627

 —

 $
 8,542,627

 Series A

 Accumulated

 Non-

 Total

 Preferred

 Additional

 Other

 Total

 controlling

 Stockholders'

 Stock

 Common
 Stock

 Paid-in

 Treasury
 Stock

 Accumulated

 Comprehensive

 Onconetix

 Capital

 Deficit

 Income

 Deficit

 Balance at December 31, 2022

 —

 —

 393,107

 $

 42,331,308

 ( 11,493
)

 ( 566,810
)

 $
 ( 19,376,500
)

 $
 —

 $
 22,388,002

 $
 —

 $
 22,388,002

 Issuance of common stock
 from exercise of preferred investment options

 —

 —

 62,155

 —

 2,272,838

 —

 —

 —

 —

 2,272,838

 —

 2,272,838

 Issuance of warrants for
 settlement of contingent warrants

 —

 —

 —

 —

 129,184

 —

 —

 —

 —

 129,184

 —

 129,184

 Issuance of Series A Preferred
 Stock

 3,000

 —

 —

 —

 3,490,000

 —

 —

 —

 —

 3,490,000

 —

 3,490,000

 Issuance of common stock
 and Series B Preferred Stock in connection with PMX Transaction

 —

 —

 91,885

 875,482

 —

 —

 —

 —

 875,484

 —

 875,484

 Assumption of stock-based
 compensation plan awards in connection with PMX Transaction

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 Exercise of stock options

 —

 —

 1,148

 —

 —

 —

 —

 —

 —

 Exercise of pre-funded warrants

 —

 —

 16,166

 —

 —

 —

 —

 —

 —

 —

 —

 —

 Issuance of restricted stock

 —

 —

 12,823

 —

 —

 —

 —

 —

 —

 —

 —

 —

 Forfeitures of restricted
 stock

 —

 ( 6,251
)

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 —

 Purchase of treasury shares

 —

 —

 —

 —

 —

 ( 1,441
)

 ( 58,981
)

 —

 —

 ( 58,981
)

 —

 ( 58,981
)

 adjustment

 —

 —

 —

 —

 —

 —

 —

 —

 2,374,957

 2,374,957

 —

 2,374,957

 Changes in pension benefit
 obligation

 —

 —

 —

 —

 —

 —

 —

 —

 5,963

 5,963

 —

 5,963

 —

 —

 —

 —

 —

 —

 —

)

 —

)

 —

)

 Balance at December 31,
 2023

 3,000

 —

 571,033

 $

 $
 49,429,031

 ( 12,934
)

 $
)

 $
 ( 56,786,194
)

 $
 2,380,920

 $
 ( 5,602,028
)

 $

 $
 1,404,476

 The accompanying notes are an integral part
of these consolidated financial statements.

 F- 6

Consolidated Statements of Cash Flows

 For the year

ended

2024

 For the year

ended

2023

 Cash flows from operating activities

 $
)

 $
)

 Adjustments to reconcile net loss to net cash used in operating activities:

 Impairment of deposit on asset purchase agreement

 -

 3,500,000

 Impairment of other long-lived assets

 -

 267,019

 Loss on impairment of goodwill

 32,347,000

 -

 Loss on impairment of ENTADFI

 3,530,717

 14,687,346

 Loss on impairment of intangibles

 10,279,796

 -

 Amortization of debt discount

 376,660

 671,373

 Amortization of debt discount - related party

 400,000

 -

 Loss on related party receivable

 -

 265,648

 Loss on extinguishment of note payable

 -

 490,000

 Depreciation and amortization

 731,345

 43,937

 Fair value of subscription agreement liability

 -

 729,900

 Net periodic pension benefit cost

 ( 48,423
)

 13,875

 438,653

 Loss on impairment of inventory of ENTADFI

 356,637

 -

 Change in fair value of contingent warrant liabilities

 ( 1,250,466
)

 91,967

 Change in fair value of subscription agreement liability

 3,259,000

 134,100

 Recovery of related party receivable

 -

 ( 159,000
)

 Provision for excess inventory

 -

 1,152,369

 Deferred tax benefit

 ( 1,045,181
)

 ( 12,593
)

 Amortization of deferred offering costs

 366,113

 -

 Gain on settlement of contingent warrant liabilities

 ( 5,282
)

 -

 Changes in assets and liabilities:

 Accounts receivable

 116,676

 ( 62,286
)

 Inventory

 ( 62,273
)

 ( 315,828
)

 Prepaid expenses and other assets

 1,018,109

 ( 412,601
)

 Prepaid expenses, LT

 ( 7,749
)

 ( 16,883
)

 Accounts payable

 ( 1,477,075
)

 3,372,648

 Accrued expenses

 ( 1,129,050
)

 ( 942,075
)

 Net cash used in operating activities

 ( 10,495,816
)

 ( 13,581,018
)

 Cash flows from investing activities

 Acquisition of assets

 -

 ( 6,079,771
)

 Cash acquired through business combination

 -

 1,056,578

 Deposit made in connection with asset purchase agreement

 -

 ( 3,500,000
)

 Purchase of other long-lived assets

 -

 ( 51,744
)

 Receivable from related party

 -

 ( 70,798
)

 Purchase of property and equipment

 ( 28,471
)

 ( 3,300
)

 Net cash used in investing activities

 ( 28,471
)

 ( 8,649,035
)

 Cash flows from financing activities

 Proceeds from issuance of notes payable - related party

 5,000,000

 -

 Payment of financing costs

 ( 400,000
)

 -

 Payment on note payables

 ( 1,345,521
)

 ( 1,000,000
)

 Proceeds from exercise of preferred investment options, net

 922,749

 2,298,675

 Proceeds from exercise of stock options

 Proceeds from exercise of warrants

 6,155

 -

 Proceeds from issuance of Series C Preferred Stock and warrants

 1,875,000

 -

 Proceeds from purchases of common stock

 685,282

 -

 Cash in lieu of shares

 ( 718
)

 -

 Deferred financing costs

 -

 ( 205,093
)

 Purchase of treasury shares

 -

 ( 58,981
)

 Net cash provided by financing activities

 6,743,110

 1,035,060

 Effect of exchange rate changes on cash

 ( 126,658
)

 ( 3,331
)

 Net (decrease) in cash

 ( 3,907,835
)

 ( 21,198,323
)

 Cash, beginning of period

 4,554,335

 25,752,659

 Cash, end of period

 $
 646,500

 $
 4,554,335

 Cash paid for interest

 $
 379,409

 $
 -

 Noncash investing and financing activities:

 Inventory and intangible assets acquired through issuance of notes payable

 $
 -

 $
 12,947,000

 Incremental fair value of exchanged preferred investment options

 $
 -

 $
 2,613,011

 Deferred offering costs included in accounts payable and accrued expenses

 $
 -

 $
 150,000

 Recognition of contingent warrant liability

 $
 157,720

 $
 25,837

 Warrants issued for settlement of contingent warrants

 $
 -

 $
 129,184

 Deferred offering costs previously included in prepaid expenses

 $
 -

 $
 ( 11,020
)

 Effect of business combination (Note 5)

 $
 -

 $
 64,054,991

 Conversion of Series B Preferred Stock to common stock

 $

 $
 -

 Settlement of related party note payable and accrued interest through issuance of common stock

 $
 5,134,247

 $
 -

 Settlement of note payable through issuance of Series A convertible preferred stock

 $
 -

 $
 3,490,000

 Exercise of pre-funded warrants

 $
 -

 $

 Issuance of restricted stock

 $
 -

 $

 Restricted stock forfeitures

 $
 -

 $
 ( 3
)

 Establishment of operating right-of-use asset

 $
 87,864

 $
 -

 Conversion to equity of non-controlling interest

 $
 7,184,751

 $
 -

 D&O insurance premium financed

 $
 678,548

 $
 -

 Receivable from shareholders for shares issued

 $
 250,308

 $
 -

 Measurement Period Adjustments from Proteomedix acquisition

 $
 10,321,000

 $
 -

 Adjustment to redeemable Series C preferred stock

 $
 125,000

 $
 -

 Deemed dividend Series C preferred stock

 $
 206,404

 $
 -

 The accompanying notes are an integral part
of these consolidated financial statements.

 F- 7

 Note 1 — Organization and Basis of Presentation

 Organization and Nature of Operations

 Onconetix, Inc. (formerly known as Blue Water
Biotech, Inc. and Blue Water Vaccines Inc.) (the "Company" or "Onconetix") was formed on October 26, 2018, and
is a commercial stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men's
health and oncology.

 On December 15, 2023, Onconetix acquired
 100 % of the issued and outstanding voting equity interests in Proteomedix AG, a Swiss company ("Proteomedix"), and its related
diagnostic product Proclarix. As a result of this transaction, Proteomedix became a wholly owned subsidiary of Onconetix (see Note 5).
Proteomedix is a healthcare company whose mission is to transform prostate cancer diagnosis. Proteomedix has identified novel biomarker
signatures with utility in prostate cancer diagnosis, prognosis and therapy management.

 In April 2023, the Company acquired ENTADFI,
a Food and Drug Administration ("FDA")-approved, once daily pill that combines finasteride and tadalafil for the treatment
of benign prostatic hyperplasia.

 Historically, the Company's focus was on
the research and development of transformational vaccines to prevent infectious diseases worldwide, until the third quarter of 2023, at
which time the Company halted its efforts on vaccine development activities to focus on commercialization activities for ENTADFI and pursue
other potential acquisitions. However, in light of (i) the time and resources needed to continue pursuing commercialization of ENTADFI,
and (ii) the Company's cash runway and indebtedness, the Company has abandoned commercialization of ENTADFI and is still working
with an investment advisor to assist with the potential sale or other transaction of the ENTADFI assets. There is currently no plan to
resume commercialization of ENTADFI, and as such, if we are not able to consummate a sale or other transaction of the ENTADFI assets,
we may abandon the assets and destroy our inventory of the product. Based on the circumstances surrounding ENTADFI, the ENTADFI assets
were fully impaired at June 30, 2024 (see Notes 4 and 5).

 On April 21, 2023, the Company filed an amendment
to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to change its corporate name from "Blue
Water Vaccines Inc." to "Blue Water Biotech, Inc." The name change was effective as of April 21, 2023. On December 15,
2023, the Company filed an amendment to its Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware
to change its corporate name from "Blue Water Biotech, Inc." to "Onconetix, Inc." In connection with each of the
name changes, the Company also amended the Company's bylaws to reflect the new corporate name.

 Reverse Stock Split

 On September 24, 2024, the Company effected a
reverse stock split of all shares of its issued and outstanding Common Stock at a ratio of one-for-forty (1:40). The Company accounted
for the reverse stock split on a retrospective basis pursuant to Accounting Standards Codification ("ASC") 260, Earnings
Per Share. All issued and outstanding common stock, common stock warrants, and share-based awards' exercise prices and per share
data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all
periods presented. The number of authorized shares and par value of the preferred stock and common stock were not adjusted because of
the reverse stock split.

 Basis of Presentation and Principles of Consolidation

 The Company's consolidated financial statements
have been prepared in conformity with accounting principles generally accepted in the United States of America ("U.S. GAAP")
and include the accounts of Onconetix and its 100 % wholly owned subsidiary, Proteomedix, since the acquisition date of December 15, 2023.
All significant intercompany balances and transactions have been eliminated in consolidation.

 The non-controlling interest recorded in the accompanying
consolidated financial statements as of December 31, 2023 relates to currently outstanding stock-based awards issued by Proteomedix, which
were assumed by Onconetix in connection with the acquisition of Proteomedix (see Note 5). During the year ended December 31, 2024, the
non-controlling interest converted to equity with the issuance of restricted common stock in exchange for PMX options.

 F- 8

 Note 2 — Going Concern and Management's
Plans

 The Company's operating activities to date
have been devoted to seeking licenses, engaging in research and development activities, potential asset and business acquisitions, and
expenditures associated with the previously planned commercial launch of ENTADFI, and the commercialization of Proclarix.

 The Company has incurred substantial operating
losses since inception and expects to continue to incur significant operating losses for the foreseeable future.

 As of December 31, 2024, the Company had cash
of approximately $ 0.6 million, a working capital deficit of approximately $ 17.3 million and an accumulated deficit of approximately $ 115.7
million. During the year ended December 31, 2024, the Company used approximately $ 10.5 million in cash for operating activities. In addition,
as of May 30, 2025, the Company's cash balance was approximately $ 0.5 million. The Company's current cash balance is not sufficient
to fund its operations through the end of December 2025. In December 2024, the Company began drawing on the Equity Financing Line of Credit
("ELOC"), which it entered into on October 2, 2024, referred herein as the ELOC Purchase Agreement; however, projections are
indicative that it will be unable to meet its contractual commitments and obligations as they come due in the ordinary course of business.
Effective in 2025, the Company has redeemed the preferred stock of approximately $ 1.71 million. The Company will require significant additional
capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the funds
needed to support the Company's working capital needs and business activities. These business activities include the commercialization
of Proclarix, and the development and commercialization of the Company's future product candidates. These factors raise substantial
doubt about the Company's ability to continue as a going concern within one year from the date of the issuance of these consolidated
financial statements.

 Management's plans for funding the Company's
operations include generating product revenue from sales of Proclarix, which may still be subject to further successful commercialization
activities within certain jurisdictions. Management also intends to secure additional required funding through equity or debt financings
if available, and to utilize the ELOC entered into in October 2024 (see Note 9) on an as-needed basis to assist with the paydown of notes
issued to Veru and to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based
on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will
not be sufficient to sustain operations. In addition, there are currently no other commitments in place for further financing nor is there
any assurance that such financing will be available to the Company on favorable terms, if at all. This creates significant uncertainty
whether the Company will have the funds available to be able to sustain its operations and expand commercialization of Proclarix. If the
Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development, and/or commercialization
of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient
to sustain operations and meet its obligations.

 Because of historical and expected operating losses
and net operating cash flow deficits, there is substantial doubt about the Company's ability to continue as a going concern for
one year from the issuance of the consolidated financial statements, which is not alleviated by management's plans. The consolidated
financial statements have been prepared assuming the Company will continue as a going concern. These consolidated financial statements
do not include any adjustments that might be necessary from the outcome of this uncertainty.

 F- 9

 Note 3 — Summary of Significant Accounting Policies

 Use of Estimates

 The preparation of the consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported
amounts of revenue and expenses during the reporting periods. The most significant estimates in the Company's consolidated financial
statements relate to accounting for acquisitions, valuation of inventory, the useful life of the amortizable intangible assets, estimates
of future cash flows used to evaluate impairment of intangible assets, accrued research and development expenses, assumptions related
to the pension benefit obligation, stock-based compensation, the valuation of preferred stock, valuation of subscription agreement liability,
and the valuation allowance of deferred tax assets. These estimates and assumptions are based on current facts, historical experience
and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual
results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and
actual results, the Company's future results of operations will be affected.

 Concentration of Credit Risk

 Financial instruments that potentially subject
the Company to concentrations of credit risk consist of cash accounts in financial institutions, which, at times, exceed the Federal Depository
Insurance Coverage limit for those maintained in the United States and exceed the Swiss Financial Market Supervisory Authority for those
maintained in Switzerland. As of December 31, 2024 and 2023, the Company has not experienced losses on these accounts and management believes
the Company is not exposed to significant risks on such accounts.

 Foreign Currency Translation

 The financial statements of Proteomedix, the Company's
foreign subsidiary, are measured using the local currency, which is the Swiss Franc, as the functional currency. Assets and liabilities
of this subsidiary are translated into U.S. dollars at exchange rates as of the consolidated balance sheet date. Equity is translated
at historical exchange rates. Revenues and expenses are translated into U.S. dollars at average rates of exchange in effect during the
period. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders' equity, as
accumulated other comprehensive income or loss. Foreign currency transaction gains and losses are included in the results of operations.
For the years ended December 31, 2024 and 2023, foreign currency translation gain (loss) was approximately $( 5.3) million and $ 2.4 million.

 Accounts receivable

 The Company
performs periodic credit evaluations of its customers' financial condition and extends credit to virtually all of its customers
on an uncollateralized basis. Credit losses to date have been insignificant and within management's expectations. The Company provides
an allowance for credit losses that is based upon a review of outstanding receivables, historical collection information, expected future
losses, and existing economic conditions. As of December 31, 2024, there was no allowance for credit losses. As of December 31,
2024, substantially all of the Company's accounts receivable are due from a single customer.

 Inventories

 Inventories consist of product acquired in the
Proteomedix transaction. Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out
basis, aside from inventories acquired in an asset acquisition or business combination, which are recorded at fair value. The Company
periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking
into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable
items are observed and there are no alternative uses for the inventory, the Company records a write-down to net realizable value in the
period that the decline in value is first recognized.

 Property and Equipment

 Property and equipment consists of laboratory
equipment, computers, and office furniture and fixtures, all of which are recorded at cost. Depreciation is recorded using the straight-line
method over the respective useful lives of the assets ranging from two to ten years. Depreciation expense was approximately $ 22,000 and
$ 7,000 for the years ended December 31, 2024 and 2023 and is included in selling, general and administrative expenses in the accompanying
consolidated statements of operations and comprehensive loss.

 F- 10

 Acquisitions

 The Company evaluates acquisitions to first
determine whether a set of assets acquired constitutes a business and should be accounted for as a business combination. If the assets
acquired are not a business, the transaction is accounted as an asset acquisition in accordance with Accounting Standards Codification
("ASC") 805-50, Asset Acquisitions ("ASC 805-50"), which requires the acquiring entity to recognize
assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, except for non-qualifying assets including
financial assets such as inventory. Further, the cost of the acquisition includes the fair value of consideration transferred and direct
transaction costs attributable to the acquisition. Goodwill is not recognized in an asset acquisition and any excess consideration transferred
over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration
payments in asset acquisitions are recognized when the contingency is determined to be probable and reasonably estimable. If the assets
acquired are a business, the Company accounts for the transaction as a business combination. Business combinations are accounted for by
using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their
respective fair values. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded
as goodwill. Acquisition related expenses are expensed as incurred, and are included in selling, general and administrative expense in
the consolidated statements of operations and comprehensive loss.

 Goodwill and Other Intangible Assets

 Goodwill represents the excess of the cost
of a business combination over the fair value of the net assets acquired. Goodwill and intangible assets deemed to have
indefinite lives are not amortized but are subject to impairment tests on an annual basis, and whenever events or changes in circumstances
indicate that the carrying value may not be recoverable. Goodwill is allocated to the reporting unit from which it was
created. A reporting unit is an operating segment or sub-segment to which goodwill is assigned when initially recorded. The
Company tests indefinite lived intangible assets for impairment, on an annual basis in the fourth quarter, or more frequently if an event
occurs or circumstances indicate that the indefinite lived assets may be impaired. The Company may perform a qualitative assessment to
determine whether it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. If the Company
determines this is the case, the Company then performs further quantitative analysis to identify and measure the amount of goodwill impairment
loss to be recognized, if any. To perform its quantitative test, the Company compares the fair value of the reporting unit to its carrying
value. If the fair value of the reporting unit exceeds the carrying value of its net assets, goodwill is not impaired, and no
further testing is required. If the fair value of the reporting unit is less than the carrying value, the Company measures the amount
of impairment loss, if any, as the excess of the carrying value over the fair value of the reporting unit. The Company did not test
its goodwill or indefinite lived assets for impairment during the year ended December 31, 2023, given that the acquisition date occurred
after the annual testing date and given that there were no impairment indicators from the date of acquisition through the end of the reporting
period. For the year ended December 31, 2024, the Company recorded losses on impairment of goodwill of approximately $ 32.3 million.

 Intangible assets with finite lives are reported
at cost, less accumulated amortization, and are amortized over their estimated useful lives, starting when sales for the related product
begin. Amortization is calculated using the straight-line method, and recorded within selling, general, and administrative expenses, or
cost of revenue, depending on the nature and use of the asset.

 During the ordinary course of business, the Company
has entered into certain license and asset purchase agreements. Potential milestone payments for development, regulatory, and commercial
milestones are recorded when the milestone is probable of achievement. Upon a milestone being achieved, the associated milestone payment
is capitalized and amortized over the remaining useful life for approved products, or expensed as research and development expense for
milestones relating to products whose FDA approval has not yet been obtained.

 Impairment of Long-Lived Assets

 The Company reviews long-lived assets, including
intangible assets with finite useful lives, for impairment whenever events or changes in business circumstances indicate that the carrying
amount of the assets may not be fully recoverable (a "triggering event"). Factors that the Company considers in deciding when
to perform an impairment review include significant underperformance of the long-lived asset in relation to expectations, significant
negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is
performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result
from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated
undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would
be based on the excess of the carrying value of the impaired asset over its fair value. During the years ended December 31, 2024 and 2023,
the Company determined that there were certain triggering events that indicated that the carrying amount of the assets recorded in connection
with the ENTADFI acquisition (see Note 5) may not be fully recoverable. Impairment losses of $ 3.5 million and $ 14.7 million were recorded
during the years ended December 31, 2024 and 2023, respectively (see Note 4). The Company also recorded an impairment loss of approximately
$ 267,000 during the year ended December 31, 2023, related to implementation costs incurred under cloud computing hosting arrangements
that were capitalized during the year.

 During the year ended December 31, 2024, the Company
determined there were certain triggering events that indicated the carrying amounts of the assets recorded in connection with the PMX
acquisition (see Note 5) may not be fully recoverable. Impairment losses of approximately $ 10.3 million related to the Company's
intangible assets were recorded during the year ended December 31, 2024 resulting in a zero balance of the intangible assets as of December
31, 2024. See Note 4 for further details.

 F- 11

 Fair Value Measurements

 Fair value is defined as the price that would
be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement
date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and
the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

 Level 1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets;

 Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

 Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

 In some circumstances, the inputs used to measure
fair value might be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is
categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement.
Financial instruments, including cash, inventory, accounts receivable, receivables from related party, accounts payable, accrued liabilities,
operating lease liabilities, and notes payable are carried at cost, which management believes approximates fair value due to the short-term
nature of these instruments.

 The fair value of the contingent warrant liability
and the related party subscription agreement liability are valued using significant unobservable measures and other fair value inputs
and are therefore classified as Level 3 financial instruments.

 The fair value of financial instruments measured on a recurring basis
is as follows as of December 31, 2024 and 2023:

 As of December 31, 2024

 Description

 Total

 Level 1

 Level 2

 Level 3

 Liabilities:

 Contingent warrant liabilities

 $
 43,089

 —

 —

 $
 43,089

 Subscription agreement liability – related party

 4,123,000

 —

 —

 4,123,000

 Total

 $
 4,166,089

 $
 —

 $
 —

 $
 4,166,089

 As of December 31, 2023

 Description

 Total

 Level 1

 Level 2

 Level 3

 Liabilities:

 Contingent warrant liability

 $
 2,641

 —

 —

 $
 2,641

 Subscription agreement liability – related party

 864,000

 —

 —

 864,000

 Total

 $
 866,641

 —

 —

 866,641

 During the year ended December 31, 2023, in connection
with the acquisition of Proteomedix, the Company recorded intangible assets, which were recognized at fair value (see Note 5). Additionally,
as a result of the impairment losses recorded on the Company's ENTADFI asset group during the year ended December 31, 2024, the
related assets were recorded at fair value as of December 31, 2024. These non-financial assets were valued using significant unobservable
measures and other fair value inputs and are therefore classified as Level 3 measurements.

 None of the Company's other non-financial
assets or liabilities are recorded at fair value on a non-recurring basis as of December 31, 2024 and 2023. There were
no transfers between levels during the periods presented.

 The following table summarizes the activity for
the related party subscription agreement liability, using unobservable Level 3 inputs, for the years ended December 31, 2024 and 2023:

 Subscription
 Agreement
 Liability

 Balance at December 31, 2022

 $
 —

 Fair value upon issuance

 729,900

 134,100

 Balance at December 31, 2023

 864,000

 3,259,000

 Balance at December 31, 2024

 $
 4,123,000

 F- 12

 Valuation of Subscription Agreement Liability

 The Subscription Agreement is accounted for as a liability in accordance
with ASC 480, Distinguishing Liabilities from Equity, ("ASC 480"), as the make-whole provision could result in a variable
number of shares being issued upon settlement. The related party subscription agreement liability is measured at fair value at the commitment
date and at each subsequent reporting period, with changes in fair value recorded as a component of other income (expense), net in the
consolidated statements of operations and comprehensive loss. As of December 31, 2024 and December 31, 2023, the fair value of the related
party subscription agreement liability is estimated to be approximately $ 4,123,000 and $ 864,000, respectively, and the change in fair
value of the related party subscription agreement liability for the year ended December 31, 2024 was an increase of approximately $ 3,259,000.
The fair value was determined using a Monte-Carlo option pricing model, and as of December 31, 2024 and 2023, the Company utilized 100 %
and 55 % probability, respectively, that the Subscription Agreement will close.

 The following table summarizes the activity for
the contingent warrant liabilities, using unobservable Level 3 inputs, for the years ended December 31, 2024 and 2023:

 Contingent
 Warrant
 Liabilities

 Balance at December 31, 2022

 $
 14,021

 Fair value at issuance

 25,837

 Reclassification to equity

 ( 129,184
)

 91,967

 Balance at December 31, 2023

 2,641

 Fair value at issuance

 1,296,196

 ( 1,250,466
)

 Gain on settlement of contingent warrant liability

 ( 5,282
)

 Balance at December 31, 2024

 $
 43,089

 Deferred Offering Costs

 The Company capitalizes certain legal, professional
accounting and other third-party fees that are directly associated with in-process equity financing as deferred offering costs until such
financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders' equity as a reduction
of proceeds generated as a result of the offering. Should the in-process equity financing be abandoned, the deferred offering costs will
be expensed immediately as a charge to expenses in the consolidated statements of operations and comprehensive loss.

 Leases

 The Company accounts for leases in accordance
with ASC 842, Leases. The Company has one lease agreement for office space, which contains an initial term of two years with renewal
options. The Company determines if an arrangement is a lease at inception. This determination generally depends on whether the arrangement
conveys to the Company the right to control the use of an explicitly or implicitly identified asset for a period of time in exchange for
consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to
obtain substantially all of the economic benefits from using the underlying asset.

 Operating lease right of use assets and operating
lease liabilities are recognized on the lease commencement date. Operating lease right of use assets represent the Company's right
to use an underlying asset for the estimated lease term and operating lease liabilities represent the Company's present value of
its future lease payments. In assessing its lease and determining its lease liability at lease commencement or upon modification, the
Company was not able to readily determine the rate implicit for its lessee arrangements and thus has used its incremental borrowing rate
on a collateralized basis to determine the present value of the lease payments. The Company's right of use asset is measured as
the balance of the lease liability plus or minus any prepaid or accrued lease payments and any unamortized initial direct costs. The operating
lease payments are recognized as lease expense on a straight-line basis over the lease term, and are included in selling, general and
administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. Lease payments included in the
measurement of the lease liability are comprised of fixed payments. If the Company's lease agreements include renewal option periods,
the Company includes such renewal options in its calculation of the estimated lease term when it determines whether the options are reasonably
certain to be exercised. When such renewal options are deemed to be reasonably certain, the estimated lease term determined under ASC
842 will be greater than the non-cancellable term of the contractual arrangement.

 Leases with an initial term of 12 months or less
are not recorded on the consolidated balance sheet and the Company recognizes lease expense for these leases on a straight-line basis
over the lease term. The Company applies this policy to all underlying asset categories.

 The Company additionally evaluates leases at their
inception to determine if the leases are to be accounted for as an operating lease or a finance lease. Lease expense for operating leases
is recognized on a straight-line basis over the lease term. Variable lease payments are recognized in the period in which the obligations
for those payments are incurred. Lease expense for finance leases is bifurcated into two components, with the amortization expense component
of the right-of-use asset recognized on a straight-line basis and the interest expense component recognized using the effective interest
method over the lease term. The Company has no financing leases as of December 31, 2024 or 2023.

 F- 13

 Defined Benefit Pension Plan

 Proteomedix sponsors
a defined benefit pension plan (the "Swiss Plan") covering its eligible Swiss employees. The Swiss Plan is government-mandated
and provides retirement benefits based on employees' years of service and compensation levels. The Company recognizes an asset for
the Swiss Plan's overfunded status or a liability for underfunded status in its consolidated balance sheets. Additionally, the Company
measures its plan's assets and obligations that determine its funded status as of the end of the year and recognizes the changes
in the funded status in the year in which the changes occur. Those changes are reported in accumulated other comprehensive loss in the
accompanying consolidated statements of convertible preferred stock and stockholders' equity. The Company uses actuarial valuations
to determine its pension and postretirement benefit costs and credits. The amounts calculated depend on a variety of key assumptions,
including discount rates and expected return on plan assets. Current market conditions are considered in selecting these assumptions.

 Collaborative Agreements

 The Company periodically enters into strategic
alliance agreements with counterparties to produce products and/or provide services to customers. Alliances created by such agreements
are not legal entities, have no employees, no assets and have no true operations. These arrangements create contractual rights and the
Company accounts for these alliances as a collaborative arrangement by reporting costs incurred and reimbursements received from transactions
within research and development expenses within the consolidated statements of operations and comprehensive loss.

 Revenue Recognition

 Development Services

 Proteomedix
provides a range of services to life sciences customers referred to as "Development Services" including testing for biomarker
discovery, assay design and development. These Development Services are performed under individual statement of work ("SOW")
arrangements with specific deliverables defined by the customer. Development Services are generally performed on a time and materials
basis. During the performance and through completion of the service to the customer in accordance with the SOW, the Company has the right
to bill the customer for the agreed upon price and recognizes the Development Services revenue over the period estimated to complete the
SOW. The Company generally identifies each SOW as a single performance obligation.

 Completion
of the service and satisfaction of the performance obligation under a SOW is typically evidenced by access to the data or test made available
to the customer or any other form or applicable manner of delivery defined in the SOW. However, for certain SOWs under which work is performed
pursuant to the customer's highly customized specifications, the Company has the enforceable right to bill the customer for work
completed, rather than upon completion of the SOW. For those SOWs, the Company recognizes revenue over a period of time during which the
work is performed based on the expended efforts (inputs). As the performance obligation under the SOW is satisfied, any amounts earned
as revenue and billed to the customer are included in accounts receivable

 F- 14

 Product Sales

 The Company derives revenue through sales of its
products, which includes Proclarix, its diagnostic product, directly to end users, including laboratories, hospitals, and medical centers,
and to distributors. As of the year ended December 31, 2024, the majority of the Company's product revenue was generated from sales
of Proclarix assays to LabCorp for review and testing in connection with the Company's license agreement with LabCorp (see Note
6). The Company considers customer purchase orders, which in some cases are governed by master sales agreements or standard terms and
conditions, to be the contracts with a customer. For each contract, the Company considers the promise to transfer products, each of which
is distinct, to be the identified performance obligations. In determining the transaction price, the Company evaluates whether the price
is subject to a refund or adjustment to determine the net consideration to which it expects to be entitled. The Company fulfills its performance
obligation applicable to product sales once the product is transferred to the customer.

 The Company's revenue was generated from
the following geographic regions during the year ended December 31, 2024:

 European
 Union

 Non-European
 Union (UK)

 United
 States

 Development services

 %

 -

 %

 -

 %

 Product sales

 %

 %

 %

 European
 Union

 Non-European
 Union (UK)

 United
 States

 Total Revenue

 Development services

 $
 2,275,088

 $
 -

 $
 -

 $
 2,275,088

 Product sales

 162,071

 23,842

 $
 63,115

 249,028

 Total

 $
 2,437,159

 $
 23,842

 $
 63,115

 $
 2,524,116

 The Company's revenue was generated from
the following geographic regions during the year ended December 31, 2023:

 European
 Union

 Non-European
 Union (UK)

 United
 States

 Development services

 %

 -

 %

 -

 %

 Product sales

 %

 -

 %

 -

 %

 European
 Union

 Non-European
 Union (UK)

 United
 States

 Total Revenue

 Development services

 $

 $
 -

 $
 -

 $

 Total

 $

 $
 -

 $
 -

 $

 The Company had the following customer concentrations
for its revenue during the years ended December 31, 2024 and 2023:

 For
 the Year Ended
 December 31, 2024

 For
 the Year Ended
 December 31, 2023

 Development

 Services

 Product

 Sales

 Development

 Services

 Product
 Sales

 Customer A

 %

 %

 %

 —
 %

 Customer B

 —
 %

 %

 —
 %

 —
 %

 Customer C

 —
 %

 %

 —
 %

 —
 %

 Customer D

 —
 %

 %

 —
 %

 —
 %

 F- 15

 Any revenues earned but not yet billed to the
customer as of the date of the consolidated financial statements are recorded as contract assets and are included in prepaid expenses
and other current assets in the accompanying consolidated financial statements. The Company had no unbilled accounts receivable as of
December 31, 2024 and an insignificant balance as of December 31, 2023. Amounts recorded in contract assets are reclassified to accounts
receivable in our consolidated financial statements when the customer is invoiced according to the billing schedule in the contract. Accounts
receivable was approximately $ 26,000 and $ 150,000 as of December 31, 2024 and December 31, 2023, respectively.

 In relation to customer contracts, the Company
incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria
for capitalization and are expensed as incurred.

 In circumstances where a SOW includes a variable
consideration component, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing
either the expected value method or the most likely amount method, depending on which method is expected to better predict the amount
of consideration to which the Company will be entitled. The value of variable consideration is included in the transaction price if, and
to the extent, it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur when the uncertainty
associated with the variable consideration is subsequently resolved. These estimates are reassessed each reporting period, as required,
and any adjustment required is recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.

 Research and Development

 The Company expenses the cost of research and
development as incurred. Research and development expenses include costs incurred in funding research and development activities, license
fees, and other external costs. Advance payments for goods and services that will be used in future research and development activities
are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and
milestone payments due to third parties that perform research and development services on the Company's behalf will be expensed
as services are rendered or when the milestone is achieved. When billing terms under research and development contracts do not coincide
with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations as of period end to
those third parties. Accrual estimates are based on several factors, including the Company's knowledge of the progress towards completion
of the research and development activities, invoicing to date under the contracts, communication from the research institution or other
companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. Significant
judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ
from the estimates made by the Company. The historical accrual estimates made by the Company have not been materially different from the
actual costs (see Note 6).

 In accordance with the Financial Accounting Standards
Board ("FASB") Accounting Standards Codification ("ASC") Topic 730-10-25-1, Research and Development, costs
incurred in obtaining licenses and patent rights are charged to research and development expense if the technology licensed has not reached
commercial feasibility and has no alternative future use. The licenses purchased by the Company (see Note 6) require substantial completion
of research and development, regulatory and marketing approval efforts to reach commercial feasibility and have no alternative future
use. Accordingly, the total purchase price for the licenses acquired is reflected as research and development on the Company's consolidated
statements of operations and comprehensive loss.

 Contingencies

 Accruals are recorded for loss contingencies when
it is probable that a liability has been incurred, and the amount of the related loss can be reasonably estimated. The Company evaluates,
on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the
liability that has been accrued previously. Considering facts known at the time of the assessment, the Company determines whether potential
losses are considered reasonably possible or probable and whether they are estimable. Based upon this assessment, the Company carries
out an evaluation of disclosure requirements and considers possible accruals in the consolidated financial statements.

 Stock-Based Compensation

 The Company expenses stock-based compensation
to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards. Stock-based
awards to employees with graded-vesting schedules are recognized, using the accelerated attribution method, on a straight-line basis over
the requisite service period for each separately vesting portion of the award.

 F- 16

 The Company estimates the fair value of stock
option grants using the Black-Scholes option pricing model and the assumptions used in calculating the fair value of stock-based awards
represent management's best estimates and involve inherent uncertainties and the application of management's judgment.

 Expected Term — The expected
term of options represents the period that the Company's stock-based awards are expected to be outstanding based on the simplified
method, which is the half-life from vesting to the end of its contractual term. The simplified method is used as the Company has insufficient
historical information to provide a basis for an estimate of the expected term.

 Expected Volatility —
Volatility is a measure of the amount by which the Company's share price has historically fluctuated or is expected to fluctuate
(i.e., expected volatility) during a period. Due to the lack of an adequate history of a public market for the trading of the Company's
common stock and a lack of adequate company-specific historical and implied volatility data, the Company computes stock price volatility
over expected terms based on comparable companies' historical common stock trading prices. For these analyses, the Company has selected
companies with comparable characteristics, including enterprise value, risk profiles, and position within the industry.

 Common Stock Fair Value —
The fair value of the common stock underlying the Company's stock options is based on the closing price of the Company's common
stock, as reported by the Nasdaq Capital Market, on the grant date of the award.

 Risk-Free Interest Rate —
The Company bases the risk-free interest rate on the implied yield available on U.S. Treasury securities with a remaining term commensurate
with the estimated expected term.

 Expected Dividend — The
Company has never declared or paid any cash dividends on its shares of common stock and does not plan to pay cash dividends in the foreseeable
future, and, therefore, uses an expected dividend yield of zero in its valuation models.

 The Company recognizes forfeitures
of equity awards as they occur.

 Income Taxes

 Income taxes are accounted for under the asset
and liability method. Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax
credit carryforwards.

 Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the jurisdictions and years in which those temporary differences are expected
to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rate is recognized in operations in the
period that includes the enactment date. Deferred tax assets are reduced to estimated amounts expected to be realized by the use of a
valuation allowance.

 Comprehensive Loss

 The Company is required to report all components
of comprehensive loss, including net loss, in the accompanying consolidated financial statements in the period in which they are recognized.
Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner
sources. The Company's comprehensive losses for the years ended December 31, 2024 and 2023 are comprised of net loss, the effect
of currency translation adjustments, and the change in pension benefit obligation.

 F- 17

 Financial instruments

 The Company determines the accounting classification
of financial instruments that are issued, including its warrants and a subscription agreement, as either liability or equity, by first
assessing whether the financial instruments are freestanding financial instruments, and if they meet liability classification in accordance
with ASC 480, Distinguishing Liabilities from Equity, ("ASC 480"), and then in accordance with ASC 815-40, Derivatives
and Hedging – Contracts in Entity's Own Equity ("ASC 815-40"). Under ASC 480-10, financial instruments are
considered liability-classified if the instruments are mandatorily redeemable, obligate the issuer to settle the instruments or the underlying
shares by paying cash or other assets, or must or may require settlement by issuing a variable number of shares.

 If the instruments do not meet liability classification
under ASC 480, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer
to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that
triggers the net cash settlement feature. If the financial instruments do not require liability classification under ASC 815-40, in order
to conclude equity classification, the Company assesses whether the instruments are indexed to the Company's common stock and whether
the instruments are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, the Company
concludes whether the instruments are classified as liability or equity. Liability-classified instruments are required to be accounted
for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after
the issuance date recorded as a component of other income (expense), net in the consolidated statements of operations and comprehensive
loss. Equity-classified instruments are accounted for at fair value on the issuance date with no changes in fair value recognized after
the issuance date.

 Preferred Stock

 The Company applies the guidance enumerated in
ASC 480, when determining the classification and measurement of preferred stock. Preferred stock subject to mandatory redemption, if any,
is classified as a liability and is measured at fair value. The Company classifies conditionally redeemable preferred stock, which includes
preferred stock that features redemption rights that are either within the control of the holder or subject to redemption upon the occurrence
of uncertain events not solely within the Company's control, as temporary equity. At all other times, the Company classifies
its preferred stock in stockholders' equity.

 Treasury Stock

 The Company records treasury stock activities under the cost method
whereby the cost of the acquired stock is recorded as treasury stock.

 F- 18

 Recently Adopted Accounting Standards

 Effective with the 2024 consolidated financial
statements, the Company adopted Accounting Standards Update (ASU) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable
Segment Disclosures, which requires disclosure of significant segment expenses and other segment items on an annual and interim basis.
The standard expanded disclosures that are required on an interim basis. Additionally, it requires a public entity to disclose the title
and position of the Chief Operating Decision Maker ("CODM"). The ASU does not change how a public entity identifies its operating
segments, aggregates them, or applies the quantitative thresholds to determine its reportable segments. The adoption of this standard
only impacted the Company's disclosures, which were made on a retrospective basis, with no impact to the results of operations,
cash flows or financial condition.

 Recent Accounting Pronouncement s Not Yet Adopted

 In December 2023, the FASB issued ASU No. 2023-09,
Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires disclosure of specific categories in the rate
reconciliation and additional information for reconciling items that meet a quantitative threshold. The amendment also includes other
changes to improve the effectiveness of income tax disclosures, including further disaggregation of income taxes paid for individually
significant jurisdictions. This ASU is effective for annual periods beginning after December 15, 2024. Adoption of this ASU should be
applied on a prospective basis. Early adoption is permitted. The Company is currently evaluating the impact that this guidance will have
on its consolidated financial statements.

 In November 2024, the FASB issued ASU No. 2024-03,
 Disaggregation of Income Statement Expenses. This guidance will require additional disclosures and disaggregation of certain costs
and expenses presented on the face of the income statement. The amendments are effective for annual reporting periods beginning after
December 15, 2026 and interim reporting period beginning after December 15, 2027 with early adoption permitted. The Company is currently
evaluating the impact of this new guidance to our consolidated financial statements.

 The Company's management does not believe
that any other recently issued, but not yet effective, accounting standards, if currently adopted, would have a material effect on the
accompanying consolidated financial statements.

 Note 4 — Balance Sheet Details

 Inventories

 Inventories, which primarily relate to Proclarix
product as of December 31, 2024 and ENTADFI product as of December 31, 2023, consisted of the following:

 2024

 2023

 Raw materials

 $
 57,446

 $
 139,208

 Work-in-process

 —

 194,805

 Finished goods

 6,633

 30,039

 Total

 $
 64,079

 $
 364,052

 The Company recorded an impairment on the ENTADFI
inventory in the amount of approximately $ 0.4 million during the year ended December 31, 2024. During the year ended December 31, 2023,
$ 1.2 million of an impairment was recorded (see Note 5).

 F- 19

 Note 4 — Balance Sheet Details (cont.)

 Prepaid Expenses and Other Current Assets

 Prepaid expenses and other current assets consisted of the following
as of December 31, 2024 and 2023:

 2024

 2023

 Prepaid insurance

 $
 101,999

 $
 122,004

 Prepaid regulatory fees

 —

 312,551

 Prepaid research and development

 —

 89,195

 Prepaid professional fees

 7,487

 70,708

 VAT taxes receivable

 28,756

 —

 Prepaid other

 33,894

 175,695

 Other Receivable

 41,835

 —

 Total

 $
 213,971

 $
 770,153

 Intangible Assets

 Intangible assets, which were recorded during
the year ended December 31, 2023 in connection with the ENTADFI and Proteomedix acquisitions (see Note 5), is comprised of customer relationships,
product rights for developed technology and a trade name, and consisted of the following as of December 31, 2024 and 2023:

 Trade name

 Product rights

 for developed

 technology

 Customer

 relationships

 Total intangible

 assets, net

 Balance at January 1, 2023

 $
 -

 $
 -

 $
 -

 $
 -

 Additions

 9,018,000

 28,447,771

 1,891,000

 39,356,771

 Impairment

 -

 ( 14,610,128
)

 -

 ( 14,610,128
)

 Amortization

 -

 ( 31,213
)

 ( 5,599
)

 ( 36,812
)

 Effect of Foreign Currency Translation

 294,739

 344,514

 61,803

 701,056

 Balance at December 31, 2023

 $
 9,312,739

 $
 14,150,944

 $
 1,947,204

 $
 25,410,887

 Measurement period adjustments related to the Proteomedix acquisition (Note 5)

 ( 6,239,000
)

 ( 3,264,000
)

 ( 818,000
)

 ( 10,321,000
)

 Impairment

 ( 2,676,441
)

 ( 9,912,392
)

 ( 987,607
)

 ( 13,576,440
)

 Amortization

 ( 185,396
)

 ( 457,144
)

 ( 66,502
)

 ( 709,042
)

 Effect of Foreign Currency Translation

 ( 211,902
)

 ( 517,408
)

 ( 75,095
)

 ( 804,405
)

 Balance at December 31, 2024

 $
 -

 $
 -

 $
 -

 $
 -

 The finite lived intangible assets held by the
Company, which includes trade name, customer relationships and product rights for developed technology, were being amortized over their
estimated useful lives, which is 15 years. Amortization expense related to intangible assets was approximately $ 0.7 million for the year
ended December 31, 2024, of which approximately $ 457,000 and $ 252,000 was recorded as cost of revenue and selling, general, and administrative
expenses, respectively, in the accompanying consolidated statements of operations and comprehensive loss. Amortization expense related
to intangible assets was approximately $ 37,000 for the year ended December 31, 2023, of which approximately $ 31,000 and $ 6,000 was recorded
as costs of revenue and selling, general, and administrative expenses, respectively.

 F- 20

 Note 4 — Balance Sheet Details (cont.)

 ENTADFI Intangible Asset Impairment

 During the three months ended March 31, 2024,
the Company became aware of a new competitor that received approval by the FDA for a combined finasteride-tadalafil capsule, which is
a direct competitor product to ENTADFI. This was determined to be a triggering event that could result in a decrease in future expected
cash flows, and thus indicated the carrying amount of the ENTADFI asset group may not be fully recoverable. The Company performed an
undiscounted cash flow analysis over the ENTADFI asset group and determined that the carrying value of the asset group is not recoverable.
The Company then estimated the fair value of the asset group to measure the impairment loss for the period. Significant assumptions used
to determine this non-recurring fair value measurement included projected sales driven by market share and product sales price estimates,
associated expenses, growth rates, the discount rate used to measure the fair value of the net cash flows associated with this asset
group, as well as Management's estimates of an expected sales price for the asset group, and the probability of each potential
strategic alternative taking place.

 During the three months ended June 30, 2024, the
Company reevaluated the probability of each potential strategic alternative occurring and determined that the change in probabilities
is a triggering event that could result in a decrease in future expected cash flows. Based on the Company's evaluation, there was
no plan to resume commercialization of ENTADFI, the Company had not identified any buyers interested to consummate a sale or other transaction
of the ENTADFI assets and was considering abandoning the product, all of which indicated the carrying amount of the ENTADFI asset group
may not be fully recoverable. The Company further determined that the asset group was fully impaired at June 30, 2024, and recorded a
corresponding impairment charge during the three months ended June 30, 2024, thus resulting in no remaining carrying value for the assets
in the ENTADFI asset group. The Company further determined that the asset group was fully impaired at June 30, 2024, and recorded a corresponding
impairment charge during the three months ended June 30, 2024, thus resulting in no remaining carrying value for the assets in the ENTADFI
asset group. There were no additional impairments for the remainder of the year ending December 31, 2024.

 Proteomedix Intangible Assets Impairment

 The Company assesses the recoverability of its
intangible with definite lives whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
During the three months ended March 31, 2024, June 30, 2024 and September 30, 2024, the Company did identify certain impairment indicators
such as the decrease in the Company's stock price; however, the Company concluded the intangible assets' values were recoverable
based on its quantitative analyses to assess the projected future undiscounted cash flows associated with the intangible assets compared
to their carrying value. Therefore, the Company recorded no impairment charges on its intangible assets during the three months
ended March 31, 2024, June 30, 2024 and September 30, 2024.

 During the three months ended December 31, 2024,
the Company identified indicators of impairment related to the intangible assets acquired in connection with the PMX acquisition. Although
the Company continued to view the underlying technologies as strategically important, it determined that it no longer possessed the operational
or financial resources required to advance their development. This conclusion was based on several factors including the Company experiencing
a substantial decline in market capitalization and share price during the three months ended December 31, 2024. The decrease in market
capitalization and share price was driven by significant recurring net losses and a decrease in the Company's liquidity position.
The Company's updated financial forecasts reflected continued and increasing net losses associated with the development and commercialization
of the PMX-related assets; however, the Company's weakened financial condition constrained its ability to raise the capital necessary
to support the continued investment in the PMX assets. This limited access to capital raise led the Company to conclude it no longer has
the ability to support the continued operation and commercialization efforts associated with the PMX assets. As a result of these factors,
the Company recorded a full impairment charge on the remaining balance of its intangible assets resulting in a zero balance at December
31, 2024.

 F- 21

 Note 4 — Balance Sheet Details (cont.)

 Goodwill

 During the three months ended March 31, 2024,
the Company's stock price and market capitalization declined, and the Company determined that this was an indicator of a potential
impairment of its goodwill, and accordingly, as of March 31, 2024, the Company performed a quantitative analysis to identify and
measure the amount of impairment loss to be recognized, if any. To perform its quantitative test, the Company compared the fair value
of the Proteomedix reporting unit to its carrying value and determined that the fair value of the reporting unit was less than its carrying
value. The Company determined the amount of impairment charges to its goodwill for the three months ended March 31, 2024 to be approximately
$ 5.2 million.

 Historically, the Company was organized in two
reporting units, Proteomedix and ENTADFI. The goodwill arising from the Proteomedix acquisition was assigned solely to the Proteomedix
reporting unit. The Company reevaluated its reporting units during the three months ended June 30, 2024, and determined that as of April
30, 2024, ENTADFI no longer qualified as a separate reporting unit. As a result, since that date, the Company's goodwill is assigned
to a single reporting unit. Accordingly, the Company performed a quantitative analysis immediately prior to the change in reporting units,
and immediately after the change in reporting units, to identify and measure the amount of impairment loss to be recognized, if any.
To perform its quantitative tests, the Company compared the fair value of the reporting unit to its carrying value and determined that
the fair value of the reporting unit was less than its carrying value. The Company determined the amount of impairment charges to its
goodwill for the three months ended June 30, 2024 to be approximately $ 10.3 million.

 During the three months ended September 30, 2024,
the Company's re-evaluation of market conditions and anticipated timing of projected sales prompted the Company to determine that
there was an indicator of a potential impairment of its related intangible assets and goodwill, and accordingly, as of September 30, 2024,
the Company performed a quantitative analysis to identify and measure the amount of impairment loss to be recognized, if any. It was determined
no further impairment on goodwill was required for the three months ended September 30, 2024.

 During the three months ended December 31, 2024,
the Company identified a measurement period adjustment relating from the Proteomedix acquisition resulting in an increase to the acquired
goodwill of approximately $ 8.4 million (see Note 5). In addition, the Company performed a re-evaluation of market conditions and anticipated
timing of projected sales which prompted the Company to determine that there was an indicator of a potential impairment of its related
goodwill. Accordingly, as of December 31, 2024, the Company performed a quantitative analysis to identify and measure the amount of impairment
loss to be recognized. It was determined there was an additional impairment on goodwill of $ 16.8 million for the three months ended December
31, 2024.

 The Company has recorded a cumulative $ 32.3 million
in impairment charges related to its goodwill for the year ended December 31, 2024.

 The fair value estimate of the reporting units
for the quarters ended March 31, 2024 and June 30, 2024 was derived from a combination of an income approach and a market approach, and
a reconciliation to the Company's market capitalization. The fair value estimate of the reporting units for the quarter ended September
30, 2024 was derived from the income approach and reconciled to the Company's market capitalization. The method was changed for
the quarter ended September 30, 2024 to reflect the disparity between the Company and the guideline transactions that were previously
selected in prior quarters. The fair value estimate of the reporting units for the quarter ended December 31, 2024 was derived from the
Company's market capitalization. Under the income approach, the Company estimated the fair value of the reporting unit based on
the present value of estimated future cash flows, which the Company considers to be a Level 3 unobservable input in the fair value hierarchy.
The Company prepared cash flow projections based on management's estimates of future revenue and operating costs, taking into consideration
the historical performance and the current macroeconomic, industry, and market conditions. The Company based the discount rate on the
weighted-average cost of capital considering Company-specific characteristics and changes in the reporting unit's projected cash
flows. Under the market approach, the Company estimated the fair value of the reporting unit based on revenue market multiples derived
from comparable companies with similar characteristics as the reporting unit, as well as an estimated control premium.

 F- 22

 Note 4 — Balance Sheet Details (cont.)

 Goodwill consisted of the following as of December
31, 2024 and 2023:

 Balance as of January 1, 2023

 $
 -

 PMX transaction goodwill

 53,914,055

 1,762,087

 Balance as of December 31, 2023

 55,676,142

 Measurement period adjustment related to the Proteomedix acquisition

 8,393,843

 Impairment loss

 ( 32,347,000
)

 ( 4,674,012
)

 Balance as of December 31, 2024

 $
 27,048,973

 Accrued Expenses

 Accrued expenses consisted of the following as of December 31,
2024 and 2023:

 2024

 2023

 Accrued compensation

 $
 186,956

 $
 487,579

 Accrued research and development

 320,096

 616,707

 Accrued professional fees

 161,981

 550,415

 Accrued implementation fees

 —

 93,787

 Accrued franchise taxes

 40,000

 60,530

 Accrued interest

 139,409

 —

 Accrued deferred offering costs

 —

 125,000

 Accrued license fees

 14,705

 —

 Other accrued expenses

 25,841

 265,849

 Total

 $
 888,988

 $
 2,199,867

 Note 5 — Acquisitions

 ENTADFI

 On April 19, 2023, the Company and Veru,
Inc. ("Veru") entered into an Asset Purchase Agreement (the "Veru APA"). Pursuant to, and subject to the terms
and conditions of, the Veru APA, the Company purchased substantially all of the assets related to Veru's ENTADFI product ("ENTADFI")
(the "Transaction") for a total possible consideration of $ 100 million.

 In accordance with the Veru APA, the Company agreed
to provide Veru with initial consideration totaling $ 20.0 million, consisting of (i) $ 6.0 million paid upon the closing of the Transaction
on April 19, 2023, (ii) an additional $ 4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii)
an additional $ 10.0 million in the form of two $ 5.0 million non-interest bearing notes payable, each due on April 19, 2024 and September
30, 2024.

 F- 23

 Additionally, the terms of the Veru APA require
the Company to pay Veru up to an additional $ 80.0 million based on the Company's net sales of ENTADFI after closing (the "Milestone
Payments"). The Milestone Payments are payable as follows: (i) $10.0 million is payable upon the first time the Company achieves
net sales from ENTADFI of $100.0 million during a calendar year, (ii) $20.0 million is payable upon the first time the Company
achieves net sales from ENTADFI of $200.0 million during a calendar year, and (3) $50.0 million is payable upon the first time the Company
achieves net sales from ENTADFI of $500.0 million during a calendar year.

 In connection with the Transaction, the Company
also assumed royalty and milestone obligations under an asset purchase agreement for tadalafil-finasteride combination entered into
by Veru and Camargo Pharmaceutical Services, LLC on December 11, 2017 (the "Camargo Obligations"). The Camargo Obligations
assumed by the Company include a 6 % royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $ 22.5 million,
payable to Camargo as follows: (i) $5.0 million is payable upon the first time the Company achieves net sales from ENTADFI of $100.0
million during a calendar year, (ii) $7.5 million is payable upon the first time the Company achieves net sales from ENTADFI of $200.0
million during a calendar year, and (3) $10.0 million is payable upon the first time the Company achieves net sales from ENTADFI of $300.0
million during a calendar year.

 On September 29, 2023, the Company entered into
an amendment to the Veru APA (the "Veru APA Amendment"), which provides that the $ 4.0 million note payable originally due
on September 30, 2023 was deemed paid and fully satisfied upon (1) the payment to the Seller of $ 1.0 million in cash on September 29,
2023, and (2) the issuance to the Seller by October 3, 2023 of 3,000 shares of Series A Convertible Preferred Stock (the "Series
A Preferred Stock") of the Company (see Note 9). Pursuant to the Veru APA Amendment, the Series A Preferred Stock will convert to
common stock of the Company one year from the date of issuance if the required stockholder approval is obtained. The Series A Preferred
Stock, which was issued to the Seller on October 3, 2023 is initially convertible, in the aggregate, into 142,479 shares of the Company's
common stock, subject to adjustment and certain stockholder approval limitations specified in the Certificate of Designations. Pursuant
to the Veru APA Amendment, the Company agreed to use commercially reasonable efforts to obtain such stockholder approval by December 31,
2023, however, such shareholder approval was not obtained as of December 31, 2023. The Company also agreed to include the shares of common
stock issuable upon conversion of the Series A Preferred Stock in the next resale registration statement filed with the SEC.

 On April 24, 2024, the Company entered into a
Forbearance Agreement with Veru in connection with the Company's default on the $ 5.0 million non-interest bearing note payable that
was due on April 19, 2024 (see Note 7).

 On September 19, 2024, the Company entered into
an Amended and Restated Forbearance Agreement with Veru, which further modified the terms of both the April and September Veru notes outstanding
(see Note 7).

 Also, in connection with, and at the time of the
Transaction, and pursuant to the Veru APA, the Company entered into non-competition and non-solicitation agreements (the "Non-Competition
Agreements") with two of Veru's key stockholders and employees (the "Restricted Parties"). The Non-Competition
Agreements generally prohibit the Restricted Parties from either directly or indirectly engaging in the Restricted Business (as such term
is defined in the Veru APA) for a period of five years from the closing of the Transaction.

 The acquisition of ENTADFI was accounted
for as an asset acquisition in accordance with ASC 805-50 because substantially all of the fair value of the assets acquired is concentrated
in a single asset, the ENTADFI product rights. The ENTADFI products rights consist of trademarks, regulatory approvals, and other records,
and are considered a single asset as they are inextricably linked.

 The following table summarizes the aggregate consideration
transferred for the assets acquired by the Company in connection with the Veru APA:

 Consideration
 Transferred

 Consideration transferred at closing

 $
 6,000,000

 Fair value of notes payable issued

 12,947,000

 Transaction costs

 79,771

 Total consideration transferred

 $
 19,026,771

 The fair value of the non-interest bearing notes
payable was estimated using a net present value model using discount rates averaging 8.2 %. The resulting fair value is being accreted
to the face value of the notes, through the respective maturity dates. Management evaluated the Milestone Payments and determined that
at the close of the Transaction, they are not considered probable, and as such, the Company did not recognize any amount related to the
Milestone Payments in the consideration transferred.

 Management evaluated the Camargo Obligations and
determined that at the close of the Transaction, the related sales milestone payments are not considered probable, and as such, the Company
did not recognize any related liability at the date of the Transaction.

 F- 24

 The following table summarizes the assets acquired with the Veru APA:

 Assets Recognized

 Inventory

 $

 1,120,000

 ENTADFI Intangible

 17,906,771

 Total fair value of identifiable assets acquired

 $

 19,026,771

 In accordance with ASC 805-50, the acquired inventory
was recorded at fair value. The remaining consideration transferred was allocated to the ENTADFI intangible asset, which will be
amortized over its estimated useful life, starting when ENTADFI sales begin. Acquired inventory is comprised of work-in-process
and raw materials. The fair value of work-in-process inventory was determined based on an estimated sales price of the finished goods,
adjusted for costs to complete the manufacturing process, costs of the selling effort, a reasonable profit allowance for the
remaining manufacturing and selling effort, and an estimate of holding costs, and resulted in a fair value adjustment of approximately
$ 0.3 million. The fair value of raw materials was determined to approximate replacement cost.

 The Company recorded an impairment charge on the
ENTADFI asset group of $ 3.5 million during the year ended December 31, 2024 (see Note 4), and an impairment charge on the ENTADFI inventory
of approximately $ 0.4 million during the year ended December 31, 2024. In addition, during the fourth quarter of 2023, the Company recorded
an impairment charge of approximately $ 14.7 million on the ENTADFI asset group, as well as an impairment charge on the ENTADFI acquired
inventory of approximately $ 1.2 million, which included impairment of 100 % of the acquired work-in-progress inventory.

 WraSer:

 On June 13, 2023 (the "Execution Date"),
the Company entered into an asset purchase agreement with WraSer, LLC, and affiliates (the "WraSer Seller") (the "WraSer
APA"). Pursuant to, and subject to the terms and conditions of, the WraSer APA, on the WraSer Closing Date (as defined below) the
Company was to purchase six FDA-approved pharmaceutical assets across several indications, including cardiology, otic infections, and
pain management (the "WraSer Assets").

 Under the terms of the WraSer APA, the Company
was to purchase the WraSer Assets for (i) $3.5 million in cash at signing of the WraSer APA; (ii) $4.5 million in cash on the later of
(x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the WraSer APA are met or otherwise
waived (the "WraSer Closing Date"); (iii) 25,000 shares of the Company's common stock (the "Closing Shares")
issuable on the WraSer Closing Date, and (iv) $500,000 in cash one year from the WraSer Closing Date.

 In conjunction with the WraSer APA, the Company
and the WraSer Seller entered into a Management Services Agreement (the "MSA") on the Execution Date. Pursuant to the terms
of the MSA, the Company will act as the manager of the WraSer Seller's business during the period between the Execution Date and
the WraSer Closing Date. During this period, the Company will make advances to WraSer, if needed. If, on the WraSer Closing Date, the
WraSer Seller's cash balance is in excess of the target amount ("Cash Target") specified in the MSA, the Company will
apply that excess to the $ 4.5 million cash payment due upon closing. Conversely, if there is a shortfall, the Company will be required
to remit the difference to the WraSer Seller over time.

 The WraSer APA could be terminated prior to the
closing upon agreement with all parties or upon breach of contract of either party, uncured within 20 days of notice. If the WraSer APA
was terminated upon agreement with all parties or upon uncured breach of contract by the Company, the initial $ 3.5 million payment would
be retained by the WraSer Seller. If it is determined that there is an uncured breach of contract by the WraSer Seller, and the WraSer
APA was terminated, the Company will have an unsecured claim against WraSer for the $ 3.5 million payment made by the Company upon execution
of the WraSer APA. The closing of the transaction is subject to certain customary closing conditions, including submission of the FDA
transfer documentation to transfer ownership of the acquired product regulatory approvals to the Company.

 F- 25

 Management evaluated the terms of the WraSer APA
and the WraSer MSA, and determined that, at the Execution Date, control under the provisions of ASC 805, Business Combinations ("ASC
805"), did not transfer to the Company; if the transaction closes, control will transfer then, and the acquisition date will be
the closing date. Management further evaluated the requirements pursuant to ASC 810, Consolidations, and determined based on the
terms of the MSA, and the Company's involvement in the WraSer Seller's business, that the WraSer Seller is a variable interest
entity ("VIE") to the Company. Management determined that the Company is not the primary beneficiary of the VIE as the WraSer
APA and MSA do not provide the Company with the power to direct the activities of the VIE that most significantly impact the VIE's
economic performance. While the Company was involved in the day-to-day business activities of the VIE until WraSer filed for relief under
Chapter 11 of the U.S. Bankruptcy Court (see below), the WraSer Seller had to approve substantially all business activities and transactions
that significantly impact the economic performance of WraSer during the term of the MSA. Additionally, the Company is not required to
absorb the losses of WraSer if the WraSer APA does not close. As such, the Company was not required to consolidate WraSer in the Company's
financial statements as of the years ended December 31, 2024 and 2023.

 The Company recorded the initial $ 3.5 million
payment as a deposit. The Company does not have any liabilities recorded as of December 31, 2024 and 2023 associated with its variable
interest in the WraSer Seller, and its exposure to the WraSer Seller's losses is limited to no more than the shortfall, if any,
of the Cash Target amount of approximately $ 1.1 million compared to the WraSer Seller's cash balance on the WraSer Closing Date.

 On September 26, 2023, WraSer and its affiliates
filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court. On October 4, 2023, the parties agreed to amend
the WraSer APA, which was subject to court approval. Shortly after its bankruptcy filing, WraSer filed a motion seeking approval of the
WraSer APA as amended. The amendment, among other things, eliminates the $ 500,000 post-closing payment due June 13, 2024 and
staggers the $ 4.5 million cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to
be paid at closing, (ii) $2.3 million, to be paid in monthly installments of $150,000 commencing January 2024 and (iii) 789 shares
of Series A Preferred Stock to be paid at closing. The amendment also reduced the number of products the Company was acquiring by
excluding pain medications and including only (i) Ciprofloxacin 0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL
and its Authorized Generic Version approved under US FDA NDA No. 208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark
CETRAXAL, and (iii) Vorapaxar Sulfate tablets under the trademark Zontivity approved under US FDA NDA N204886.

 In October 2023, WraSer alerted the Company
that its sole manufacturer for the active pharmaceutical ingredient ("API") for Zontivity, the key driver for the WraSer acquisition,
would no longer manufacture the API for Zontivity. The Company believes that this development constituted a Material Adverse Effect under
the WraSer APA and the WraSer MSA, enabling the Company to terminate the WraSer APA and the WraSer MSA. On October 20, 2023, the Company
filed a motion for relief from the automatic stay in the Bankruptcy Court so that the Company can exercise the termination rights under
the WraSer APA, as amended. On December 18, 2023, the Bankruptcy Court entered into an Agreed Order lifting the automatic stay to
enable the Company to exercise its rights to terminate the WraSer APA and the WraSer MSA. On December 21, 2023, the Company
filed a Notice with the Bankruptcy Court terminating the WraSer APA and the WraSer MSA. WraSer has advised the Company that it does
not believe that a Material Adverse Effect occurred. Due to the WraSer bankruptcy filing and the Company's status as an unsecured
creditor of WraSer, it is unlikely that the Company will recover the $ 3.5 million initial payment made, or any costs and resources in
connection with services provided by the Company under the WraSer MSA, and therefore the Company recorded a loss on impairment for the
$ 3.5 million deposit during the year ended December 31, 2023.

 F- 26

 Proteomedix

 On December 15, 2023 (the "Acquisition Date"), Onconetix
entered into a Share Exchange Agreement (the "Share Exchange Agreement") with Proteomedix and each of the holders of outstanding
capital stock or Proteomedix convertible securities (other than Proteomedix stock options) (collectively the "Sellers"), pursuant
to which the Company acquired 100 % of the outstanding common shares and voting interest of Proteomedix, through the issuance of
 91,885 shares of common stock and 2,696,729 shares of Series B Convertible Preferred Stock (the
"PMX Transaction") convertible into 6,741,820 shares of Common Stock.

 Upon approval by
the requisite vote of stockholders of Onconetix at the Special Meeting of the Stockholders ("Stockholder Approval"), each
share of Series B Convertible Redeemable Preferred Stock ("Series B Preferred Stock") was automatically convertible into 100 shares
of common stock in accordance with the terms of the Series B Certificate of Designation (the "Conversion"). If Stockholder
Approval was not obtained by January 1, 2025, Onconetix was, at the option of the holders, obligated to cash settle the Series B Preferred
Stock at the option of the holders. The Series B Preferred Stock outstanding as a result of the PMX Transaction was convertible into 6,741,820 shares
of common stock. Stockholder Approval was obtained on September 5, 2024 and the Conversion occurred subsequently on September 24, 2024
(see Note 9).

 The consummation (the "Closing")
of the PMX Transaction was subject to customary closing conditions and the agreement to enter into a subscription agreement (see Note
8) with Altos Ventures, a shareholder of Proteomedix, prior to the closing of the PMX Transaction (the "PMX Investor").

 In addition, each option to purchase
shares of Proteomedix (each, a "Proteomedix Stock Option") outstanding immediately before the Closing, whether vested or unvested,
remains outstanding until the Conversion unless otherwise terminated in accordance with its terms. At the Conversion, each outstanding
Proteomedix Stock Option, whether vested or unvested, shall be assumed by Onconetix and converted into the right to receive (a) an option
to acquire shares of common stock (each, an "Assumed Option") or (b) such other derivative security as Onconetix and Proteomedix
may agree, subject in either case to substantially the same terms and conditions as were applicable to such Proteomedix Stock Option immediately
before the Closing. Each Assumed Option shall: (i) represent the right to acquire a number of shares of common stock equal to the product
of (A) the number of Proteomedix common shares that were subject to the corresponding Proteomedix Option immediately prior to the Closing,
multiplied by (B) the Exchange Ratio (as defined in the Share Exchange Agreement"); and (ii) have an exercise price (as rounded
down to the nearest whole cent) equal to the quotient of (A) the exercise price of the corresponding Proteomedix Option, divided by (B)
the Exchange Ratio. The Company completed the Conversion on September 24, 2024, and the Company is in process of exchanging
the Proteomedix Stock Options into Onconetix restricted stock units as of the date of this filing. As of December 31, 2024, the PMX option
holders continue to own Proteomedix Stock Options.

 Management determined
that the PMX Transaction was a business combination as defined within ASC 805, and that Onconetix was the accounting acquirer.
The Company determined that Onconetix was the accounting acquirer based on the guidance contained within ASC 805-10. The significant factors
that led to the Company's conclusion were ( i) the Company obtained 100% of the outstanding common stock and voting interest of PMX,
(ii) at closing of the PMX Transaction, the PMX shareholders were issued approximately 17% of Onconetix's outstanding common stock
and none of the former PMX shareholders held more than 5% of Onconetix's common stock individually, (iii) the composition of executive
management and the governing body did not change sufficiently to give PMX or its former shareholders control over these functions within
Onconetix, and (iv) Onconetix was significantly larger when considering both total assets and operations. As a result, the
Company has applied purchase accounting as of the Closing of the PMX Transaction. The assets, liabilities, and non-controlling interest
of Proteomedix were recognized at fair value as of the Closing and the results of its operations have been included within Onconetix's
consolidated statements of operations and comprehensive loss from that date forward.

 F- 27

 The acquisition-date fair value of the consideration
transferred totaled approximately $ 65.1 million, which consisted of the following:

 Consideration
 Transferred

 Common stock

 $
 875,484

 Series B convertible preferred stock

 Total consideration transferred

 $
 65,111,569

 The fair value of the Company's common shares
issued as consideration was based on the closing price of the Company's common stock as of the Acquisition Date. The fair value
of the Series B Preferred Stock issued as consideration was based on the underlying fair value of the number of common shares that the
Series B Preferred Stock converts into, also based on the closing price of the Company's common stock as of the Acquisition Date.

 The fair value of the Proteomedix stock options
assumed as part of the PMX Transaction was determined using a Black-Scholes option pricing model with the following significant assumptions:

 Exercise price

 $
 1.15 – 28.83

 Stock price

 $
 128.11

 Term (years)

 0.17 – 3.59

 Expected stock price volatility

 %

 Risk-free rate of interest

 4.07 % – 5.47
 %

 We finalized the purchase price allocation on
December 15, 2024. The following table summarizes the fair values of the assets acquired, and liabilities assumed at the acquisition date:

 As Initially

Reported

 Measurement

Period

Adjustments

 As
Adjusted

 Cash

 $
 1,056,578

 $
 -

 $
 1,056,578

 Accounts receivable

 87,445

 -

 87,445

 Inventories

 80,593

 -

 80,593

 Prepaid expenses and other current assets

 114,615

 -

 114,615

 Right of use asset

 149,831

 -

 149,831

 Property and equipment, net

 39,779

 -

 39,779

 Trade name

 9,018,000

 ( 6,239,000
)

 2,779,000

 Customer relationships

 1,891,000

 ( 818,000
)

 1,073,000

 Product rights for developed technology

 10,541,000

 ( 3,264,000
)

 7,277,000

 Goodwill

 53,914,055

 8,393,843

 62,307,898

 Total assets acquired

 76,892,896

 ( 1,927,157
)

 74,965,739

 Accounts payable

 ( 234,029
)

 -

 ( 234,029
)

 Accrued expenses

 ( 732,814
)

 -

 ( 732,814
)

 Operating lease liability

 ( 149,831
)

 -

 ( 149,831
)

 Deferred tax liability

 ( 2,994,669
)

 1,927,157

 ( 1,067,512
)

 Pension benefit obligation

 ( 548,384
)

 -

 ( 548,384
)

 Note payable

 ( 115,096
)

 -

 ( 115,096
)

 Total liabilities assumed

 ( 4,774,823
)

 1,927,157

 ( 2,847,666
)

 Net assets

 72,118,073

 -

 72,118,073

 Less non-controlling interest

 ( 7,006,504
)

 -

 ( 7,006,504
)

 Net assets acquired

 $
 65,111,569

 $
 -

 $
 65,111,569

 F- 28

 During the year ended December 31, 2024, we recorded
measurement period adjustments to decrease intangible assets, specifically the trade name, customer relationships, and product rights
for developed technology, as a result of revised future cash flow estimates and to decrease deferred tax liability as a result of changes
in net operating loss estimates from the initial purchase price allocation. In addition, the measurement period adjustment included a
change in the useful life determination of the tradename from indefinite to 15-years. These measurement period adjustments were made to
reflect facts and circumstances that existed as of the acquisition date. The net effect of these adjustments would have resulted in an
insignificant decrease in amortization expense recorded during the year ended December 31, 2024. The measurement period adjustments were
recorded in our consolidated financial statements as of and for the year ended December 31, 2024.

 The goodwill recognized as a result of the PMX
Transaction is attributable primarily to expected synergies and the assembled workforce of Proteomedix. None of the goodwill is expected
to be deductible for income tax purposes.

 The fair values of the acquired tangible and intangible
assets were determined using variations of the cost, income approach using the excess earnings, lost profits and relief from royalty methods.
The income approach valuation methodology used for the intangible assets acquired in the PMX Transaction makes use of Level 3 inputs.

 The trade name intangible asset represents the
value of the Proclarix brand name and was valued using a relief from royalty method under an income approach. A royalty rate of
 6 % was utilized in determining the fair value of this intangible asset. The fair value of this asset was determined based on a cash flow
model using forecasted revenues and expenses specifically tied to Proclarix. Those cash flows were then discounted at 10 % determined
by the use of a weighted average return on assets analysis The estimated useful life of the trade name of 15-years was determined based
on the underlying patent's remaining life.

 The customer relationship intangible assets represent
the value of the existing customer contract with LabCorp (see Note 5) and was valued using the lost profits method under the income approach.
The fair value of this asset was determined based on a cash flow model using forecasted revenues specifically tied to Proteomedix's
LabCorp contract. Those cash flows were then discounted at 10 % determined by the use of a weighted average return on assets analysis.
The estimated useful life of this asset was determined by reference to the estimated life of the product rights associated with the LabCorp
contract.

 The product rights for developed technology acquired
in the PMX Transaction represents know-how and patented intellectual property held by PMX pertaining to its commercial-ready prostate
cancer diagnostic system, Proclarix. The fair value of this asset was determined based on a cash flow model based on forecasted
revenues and expenses specifically tied to Proclarix. Those cash flows were then discounted at 7 % for the period prior to patent
expiration and 14 % for the period thereafter. The discount rates were determined by the use of a weighted average return on assets analysis.
The estimated useful life of the product rights was determined based on the underlying patent's remaining life.

 F- 29

 The fair value of the non-controlling interest
in Proteomedix was estimated to be $ 7.0 million and represented the fair value of the vested Proteomedix stock options outstanding as
of the Acquisition Date. The fair value of the non-controlling interest was valued using the methodology applicable to the Proteomedix
stock options disclosed above. As Proteomedix was a private company as of the Acquisition Date, the fair value measurement is based on
significant inputs that are not observable in the market and thus represents a Level 3 measurement as defined in ASC 820, Fair Value
Measurement.

 The Company recognized approximately $ 1.5 million
of acquisition related costs that were expensed during 2023, including the fair value of the subscription agreement liability, which was
a closing condition for the PMX Transaction (see Note 8).

 The amounts of revenue and loss of Proteomedix,
included in the Company's consolidated statements of operations and comprehensive loss from the Acquisition Date through December
31, 2023 are as follows:

 Revenue

 $

 $
 315,688

 The following summary, prepared on a pro forma
basis, presents the Company's unaudited consolidated results of operations for 2023 and 2022 as if the PMX Transaction had been
completed as of January 1, 2022. The pro forma results below include the impact of amortization of intangible assets. This pro forma
information is presented for illustrative purposes only, is not necessarily indicative of future results of operations and does not include
any impact of transaction synergies. In addition, the pro forma results are not necessarily indicative of the results of operations that
actually would have been achieved had the PMX Transaction been consummated as of that date:

 Unaudited

 2023

 2022

 Revenue

 $
 2,601,310

 $
 392,460

 $
 38,577,046

 $
 16,326,247

 Note 6 — Significant Agreements

 Services Agreement

 On July 21, 2023, the Company, entered into a
Licensing and Services Master Agreement ("Master Services Agreement") and a related statement of work with a vendor, pursuant
to which the vendor was to provide to the Company commercialization services for the Company's products, including recruiting, managing,
supervising and evaluating sales personnel and providing sales-related services for such products, for fees totaling up to $ 29.1 million
over the term of the statement of work. The statement of work had a term through September 6, 2026, unless earlier terminated in accordance
with the Master Services Agreement and the statement of work. On July 29, 2023, a second statement of work was entered into with the same
vendor for certain subscription services providing prescription market data access to the Company. The fees under the second statement
of work totaled approximately $ 800,000, and the term was through July 14, 2025. On October 12, 2023, the Company terminated the Master
Services Agreement and the statements of work. During 2023, the Company recognized a termination fee of approximately $ 1.4 million included
in selling, general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss. Subsequently
during 2024, the Company agreed with the vendor to pay a reduced termination fee of approximately $ 0.9 million and recorded net credits
of $0.5 million for the difference in the termination fee related to this contract during the year ended December 31, 2024, which is included
in selling, general and administrative expense in the accompanying consolidated statements of operations and comprehensive loss. The Company
had approximately $ 1.1 million and $ 1.8 million recorded in related accounts payable as of December 31, 2024 and 2023, respectively, which
includes amounts due for early termination of the contract.

 F- 30

 Note 6 — Significant Agreements (cont.)

 Laboratory Corporation of America

 On March 23, 2023, Proteomedix
entered into a license agreement with LabCorp, pursuant to which LabCorp has the exclusive right to develop and commercialize Proclarix,
and other products developed by LabCorp using Proteomedix's intellectual property covered by the license, in the United States ("Licensed
Products"). In consideration for granting LabCorp an exclusive license, Proteomedix received an initial license fee of in the mid-six
figures upon signing of the contract. Additionally, Proteomedix is entitled to royalty payments of between 5 % and 10 % on the net sales
recognized by LabCorp of any Licensed Products plus milestone payments as follows:

 after the first sale of Proclarix as a laboratory developed test, LabCorp will pay an amount in the mid-six figures,

 after LabCorp achieves a certain amount in the low seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures,

 after a certain amount in the mid-seven figures in net sales of Licensed Products, LabCorp will pay Proteomedix an amount in the low seven figures.

 The total milestone payments available under the
terms of this contract are $ 2.5 million. An additional $ 0.5 million was paid to Proteomedix as an initial license fee in 2023.

 LabCorp is wholly responsible for the cost, if
any, of research, development and commercialization of Licensed Products in the United States but has the right to offset a portion of
those costs against future royalty and milestone payments. Additionally, LabCorp may deduct royalties or other payments made to third
parties related to the manufacture or sale of Licensed Products up to a maximum amount of any royalty payments due to Proteomedix. There
was no such activity under the agreement for the year ended December 31, 2024.

 The license agreement and related royalty payment
provisions expire during 2038, which approximates the expiration of the last patent covered by the license agreement. LabCorp has the
right to terminate the license agreement for any reason by providing 90 days written notice to Proteomedix. Either party may terminate
the license agreement due to a material reach of the terms of the license agreement with 40 days' notice, provided such breach is
not cure within the foregoing 30-day period. Finally, Proteomedix may terminate the license agreement with 60 days' notice in the
event LabCorp fails to make any undisputed payment due, provided that LabCorp does not remit the payment within the foregoing 60-day period.

 As of December 31, 2024, the sale of Licensed
Products by LabCorp under the license agreement has not commenced. The Company has sold product to LabCorp for their use in internal trials
of the test.

 Note 7 — Notes Payable

 Veru Notes Payable

 In connection with the Veru APA (see Note 5),
the Company executed three non-interest bearing notes payable (the "Notes") in the principal amounts of $ 4.0 million, $ 5.0
million and $ 5.0 million with initial maturity dates of September 30, 2023, April 19, 2024, and September 30, 2024, respectively. In accordance
with the Notes, no principal payments are due until maturity, however, the Company may voluntarily prepay the Notes with no penalty. Additionally,
in an Event of Default, as defined in the Notes, the unpaid principal amount of the Notes will accrue interest at a rate of 10.0 % per
annum.

 The Company imputed interest on the Notes using
an average discount rate of 8.2 % and recorded a debt discount of approximately $ 1.1 million at the issuance date. The debt discount is
reflected as a reduction in the carrying amount of the Notes and amortized to interest expense through the respective maturity dates,
using the effective interest method.

 F- 31

 Note 7 — Notes Payable (cont.)

 On September 29, 2023, the Company and the note
holder entered into an amendment to the Veru APA, which provided that the $ 4.0 million note payable originally due on September 30, 2023
was deemed paid and fully satisfied upon (1) the payment to the Seller of $ 1.0 million in cash on September 29, 2023, and (2) the issuance
to the Seller by October 3, 2023 of 3,000 shares of Series A Preferred Stock of the Company (see Note 5). In connection with the Veru
APA Amendment, the Company recorded an extinguishment loss on the note payable of approximately $ 490,000, which represents the difference
between the fair value of the Series A Preferred Stock that was issued to settle the debt and the carrying value of the note payable as
of September 29, 2023. Pursuant to the Veru APA Amendment, the Series A Preferred Stock would convert to common stock of the Company one
year from the date of issuance if the required stockholder approval was obtained. The Series A Preferred Stock, which was issued to the
Seller on October 3, 2023 was initially convertible, in the aggregate, into 142,749 shares of the Company's common stock, subject
to adjustment and certain stockholder approval limitations specified in the Certificate of Designations. Stockholder approval was obtained
during September 2024 and therefore subsequent conversion of the Series A Preferred Stock to common stock was consummated by the Company
during the quarter ended September 30, 2024 (see Note 9). The Company also agreed to include the shares of common stock issuable upon
conversion of the Series A Preferred Stock in the next resale registration statement filed with the SEC. To that end, the Company registered
 130,321 shares of common stock, out of the 142,749 shares issued to Veru, in a registration statement filed with the SEC on November 1,
2024. Of the 142,749 shares issued to Veru originally, 12,428 shares were sold prior to registration. As a result, the remaining unsold
shares of 130,321 were registered.

 On April 24, 2024, the Company entered into a
forbearance agreement with Veru (the "Original Forbearance Agreement") due to the Company's failure to repay the principal
balance on the $ 5.0 million note payable that had a maturity date of April 19, 2024 (the "April Veru Note"). Pursuant to the
Original Forbearance Agreement, Veru will forbear from exercising its rights and remedies under the April Veru Note as a result of this
default, until March 31, 2025 (the "April 2024 Forbearance Period").

 Interest will accrue on any unpaid principal balance
of the April Veru Note at a rate of 10 % per annum, commencing on April 20, 2024 through the date that the outstanding principal balance
under the April Veru Note is paid in full. Any such accrued interest will become immediately due and payable upon the earlier of (i)certain
events of default under the April Veru Note or the $ 5.0 million note payable that matures on September 30, 2024 (the "September
Veru Note"), (ii) a payment default under the September Veru Note and (iii) the final payment of any principal amount payable under
the September Veru Note. No interest was to accrue under the September Veru Note during the April 2024 Forbearance Period unless an Event
of Default (as defined in the Original Forbearance Agreement) occurs, in which case interest will accrue from and after the date on which
such default occurs.

 In consideration for Veru's entrance into
the Original Forbearance Agreement, the Company agreed to pay Veru:

 $ 50,000 of the principal due under the April Veru Note, which was paid on April 25, 2024, and up to $ 10,000 of out-of-pocket expenses incurred by Veru in connection with the Original Forbearance Agreement;

 15 % of (i) the monthly cash receipts of Proteomedix for the licensing or sale of any products or services, (ii) monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix anywhere in the world, and (iii) monthly cash receipts of the Company or any of its subsidiaries for milestone payments or royalties from LabCorp; and

 10 % of the net proceeds from any financing or certain asset sale, transfer or licensing transactions that are consummated prior to March 31, 2025.

 The Company also agreed to a general release of
claims against Veru and its representatives arising out of or relating to any act or omission thereof prior to April 24, 2024.

 The Company determined that the Original Forbearance
Agreement should be accounted for as a modification of the April Veru Note and the September Veru Note in accordance with ASC 470-50,
 Debt - Modifications and Extinguishments ("ASC 470"), as the change in cash flows expected under the April Veru Note
and the September Veru Note was not substantial. A new effective interest rate was established based on the carrying value of the original
Notes and the revised cash flows and no gain or loss was recorded.

 On September 19, 2024, the Company entered into
an Amended and Restated Forbearance Agreement with Veru (the "Amended and Restated Forbearance Agreement" or "A&R
Forbearance Agreement"), which amends and restates the Original Forbearance Agreement in its entirety. Pursuant to the A&R Forbearance
Agreement, Veru will forbear from exercising its rights under both the April Veru Note and the September Veru Note, subject to the terms
and conditions set forth below.

 F- 32

 Note 7 — Notes Payable (cont.)

 The A&R Forbearance Agreement extends the
due date for the April 2024 and September 2024 Veru Notes until the earlier to occur of (i) June 30, 2025 or (ii) the occurrence of any
Event of Default. The Amended and Restated Forbearance Agreement also effected certain modifications to the payment terms in the Original
Forbearance Agreement and amended certain terms of the September Veru Note as summarized below.

 Pursuant to the A&R Forbearance Agreement,
the Company agreed to make the following required payments (the "Required Payments") during the April 2024 Forbearance Period,
first to accrued and unpaid interest under the April Veru Note and then any remainder to the outstanding principal amount of the April
Veru Note:

 Interest at the rate of 10 % per annum shall accrue on any unpaid principal balance of the April Veru Note commencing on April 20, 2024 through the date that the outstanding principal balance under the April Veru Note is paid in full;

 Monthly payments equal to 25 % (increased from 15 % in the Original Forbearance Agreement) of (i) the monthly cash receipts of Proteomedix for the licensing or sale of any products or services, (ii) monthly cash receipts of the Company or any of its subsidiaries for the sales of Proclarix anywhere in the world, and (iii) monthly cash receipts of the Company or any of its subsidiaries for milestone payments or royalties from LabCorp cash receipts of the Company or any of its subsidiaries from certain sale or licensing revenues or payments (the "Ordinary Cash Revenue"), which increased amount began October 20, 2024 for cash receipts in September 2024;

 Payment of 20 % (increased from 10 % in the Original Forbearance Agreement) of the net proceeds from certain financing or other transactions outside the ordinary course of business completed by the Company or any of its subsidiaries during the April 2024 Forbearance Period, which increased amount will begin for any net proceeds received after September 19, 2024; and

 The remaining balance of the April Veru Note will be due at the end of the April 2024 Forbearance Period.

 The Company
and Veru also agreed to the following amendments to the September Veru Note in the A&R Forbearance Agreement:

 As noted above, an extension of the maturity date to June 30, 2025;

 The accrual of interest at the rate of 10 % per annum on any unpaid principal balance of the September Veru Note commencing on October 1, 2024 through the date that the outstanding principal balance under the September Veru Note is paid in full;

 Any amounts owed on the September Veru Note, including but not limited to unpaid principal and accrued interest, will be paid in cash or, upon the mutual written consent of Veru and the Company, in shares of the Company's Common Stock or a combination of cash and the Company's Common Stock;

 Following full repayment of all principal and interest under the April Veru Note, the Company will make the Required Payments first towards accrued and unpaid interest under the September Veru Note and then towards the remaining principal balance payable under the September Veru Note;

 If the aggregate unpaid principal outstanding under the April Veru Note and the September Veru Note and all accrued and unpaid interest thereon is repaid in cash on or before December 31, 2024, then the total principal balance under the September Veru Note that will be payable by the Company in satisfaction of its obligations under the September Veru Note will be reduced from $ 5.0 million to $ 3.5 million.

 The Company determined the A&R Forbearance
Agreement should be accounted for as a modification of both the April and September Veru Notes in accordance with ASC 470-50, Debt
- Modifications and Extinguishments ("ASC 470"), as the change in cash flows expected under the April Veru Note and the
September Veru Note was not substantial. A new effective interest rate was established based on the carrying value of the original Notes
and the revised cash flows and no gain or loss was recorded.

 On November 26, 2024, the Company entered into
another Amended and Restated Forbearance Agreement with Veru (the "November Amended and Restated Forbearance Agreement" or
"November A&R Forbearance Agreement"), which amends and restates certain terms of the Amended and Restated Forbearance
Agreement. Pursuant to the November A&R Forbearance Agreement, Veru agreed to waive the due date for payment of applicable Cash Receipt
Payments (as such term is defined in the A&R Forbearance Agreement) generated in October 2024 until the Company receives funds of
at least $ 97,000 pursuant to its equity line of credit facility with Keystone Capital Partners LLC. In exchange, the Company agreed to
increase its payments to be made to Veru out of future financing and strategic transactions through June 30, 2025, from 20 % to 25 % of
net proceeds generated from such transactions. All other terms of the A&R Forbearance Agreement with Veru remain the same. Management
has evaluated and concluded that there is no accounting impact from the A&R Forbearance Agreement with Veru.

 During the year ended December 31, 2024 and 2023,
the Company recorded approximately $ 1.4 million and $ 0.7 million of associated interest expense, respectively, which includes accrued
interest and amortization of the debt discount. The unamortized debt discount as of December 31, 2024 and 2023 was $ 5,000 and $ 0.4 million.
As of December 31, 2024, the Company has recorded accrued interest of approximately $ 0.1 million on the Notes, which is included in accrued
expenses in the accompanying consolidated balance sheets.

 Future minimum principal payments on the Notes
as of December 31, 2024 include $ 4.3 million in principal payments that are due in March 2025 and $ 5.0 million principal payments that
are due in June 2025.

 F- 33

 Note 7 — Notes Payable (cont.)

 Related Party Debenture

 On January 23, 2024, the Company issued a non-convertible
debenture (the "Debenture") to the PMX Investor, a related party, in the principal sum of $ 5.0 million, in connection with
the Subscription Agreement discussed in Note 8. The Debenture has an interest rate of 4.0 % per annum, and the principal and accrued interest
was originally payable in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June 30, 2024. Additionally,
the $ 5.0 million subscription amount under the Subscription Agreement shall be increased by the amount of interest payable under the Debenture.

 On April 24, 2024, the maturity date of the related
party debenture was extended to October 31, 2024, through the execution of an extension agreement (the "Extension Agreement")
between the Company and the PMX investor. No other terms of the Debenture were modified in connection with the Extension Agreement.

 The Company considered the guidance of ASC 470-60,
 Troubled Debt Restructuring by Debtors, and concluded that the Extension Agreement should be accounted for as a troubled debt restructuring
as the Company is experiencing financial difficulty and since the effective borrowing rate under the Extension Agreement is less than
the effective borrowing rate under the original agreement, which indicates that a concession is deemed to have been granted. This did
not result in a gain on restructuring as the future undiscounted cash outflows required under the Extension Agreement exceed the carrying
value of the Debenture immediately prior to the extension. A new effective rate was established based on the carrying value of the original
Debenture and the revised cash flows.

 In connection with the issuance of the Debenture,
the Company incurred approximately $ 0.4 million in financing fees, which was recorded as a debt discount, and reflected as a reduction
in the carrying amount of the Debenture. The debt discount is being amortized to interest expense through the maturity date. The Company
did not incur any financing fees in connection with the Extension Agreement.

 On September 24, 2024, the Company converted all
unpaid principal and accrued interest due under the Debenture into 500,000 units, attributable to principal, and 13,424 units, attributable
to accrued interest, upon the closing of the Subscription Agreement. Each unit consisted of 1 share of common stock and 0.30 pre-funded
warrants at an exercise price of $ 0.04 per share. As a result of the transaction, 513,424 shares of common stock were issued, and 154,027
pre-funded warrants were issued. As of December 31, 2024, there is no outstanding balance or accrued interest remaining on the Debenture.
The remaining unamortized debt discount was immediately expensed upon settlement.

 The Company recorded approximately $ 0.5 million
of interest expense on the Debenture during the year ended December 31, 2024, respectively, which includes accrued interest and amortization
of the debt discount.

 Insurance Financing

 During the year ended December 31, 2024, the Company
obtained financing for certain Director & Officer liability insurance policy premiums. The agreement assigns the lender a first priority
lien on and security interest in the financed policies and any additional premium required in the financed policies.

 The total premiums, taxes and fees financed are
approximately $ 0.7 million, with an annual interest rate of 7.79 %. In consideration of the premium payment by the lender to
the insurance companies or the agent or broker, the Company unconditionally promised to pay the lender the amount financed plus interest
and other charges permitted under the agreement. As of December 31, 2024, the company had paid off the insurance financing note payable.
The Company paid the insurance financing through monthly installment payments of approximately $ 78,000, the last payment for the note
was paid on November 17, 2024.

 PMX Note Payable

 The Company also assumed an obligation in the
amount of 100,000 CHF, in connection with the Proteomedix acquisition. This obligation relates to a loan from an investor that was advanced
to Proteomedix in March 2010. This loan bears no interest, is unsecured and may be cancelled by the Company at its discretion. The loan
was terminated in the fourth quarter of 2024. The long term note payable has no outstanding balance as of December 31, 2024.

 F- 34

 Note 8 — Subscription Agreement

 On December 18, 2023, the Company entered into
a subscription agreement (the "Subscription Agreement") with the PMX Investor, who became a stockholder of Onconetix at the
closing of the PMX Transaction (see Notes 5 and 11), for the sale of 500,000 units, each comprised of 1 share of common stock and 0.30
pre-funded warrants (the "Units") at $ 10 per Unit. The Subscription Agreement includes a make-whole provision which requires
the issuance of additional shares of common stock in the event that the 270-day volume weighted average price after the closing of the
Subscription Agreement, is below $ 10, and the PMX Investor still holds the common shares acquired upon closing of the Subscription Agreement
270 days after such closing. The Subscription Agreement would only close upon obtaining Stockholder Approval for certain transactions
involving the Company's Series B Preferred Stock, as further described in Note 5. The Subscription Agreement was amended on January
23, 2024 to include a provision for interest on the $ 5 million debenture, accruing at a rate of 4 %, to be included in the calculation
of the units to be issued upon the Conversion. Stockholder approval was obtained on September 5, 2024, and as a result, the Conversion
and the issuance of 500,000 units, attributable to the Subscription Agreement, and 13,424 units, attributable to additional accrued interest
under the debenture to the PMX Investor took place on September 24, 2024. Due to the issuance, the make-whole took effect and remains
in place until June 24, 2025.

 The Subscription Agreement is accounted for as
a liability in accordance with ASC 480, Distinguishing Liabilities from Equity, ("ASC 480"), as the make-whole provision
could result in a variable number of shares being issued upon settlement. The related party subscription agreement liability is measured
at fair value at the commitment date and at each subsequent reporting period, with changes in fair value recorded as a component of other
income (expense), net in the consolidated statements of operations and comprehensive loss. As of December 31, 2024 and December 31, 2023,
the fair value of the related party subscription agreement liability is estimated to be approximately $ 4,123,000 and $ 864,000, respectively,
and the change in fair value of the related party subscription agreement liability for the year ended December 31, 2024 was an increase
of approximately $ 3,259,000. The fair value was determined using a Monte-Carlo option pricing model, and as of December 31, 2024 and 2023,
the Company utilized 100 % and 55 % probability, respectively, that the Subscription Agreement will close. The significant assumptions used
in the Monte-Carlo model, which utilizes Level 3 inputs (see Note 3), are as follows as of December 31, 2024 and 2023:

 2024

 2023

 Exercise price

 $

 $

 Term (years)

 0.48

 1.2

 Expected stock price volatility

 %

 %

 Risk-free rate of interest

 4.25
 %

 4.64
 %

 Authorized Capital

 As of December 31, 2024 and 2023, the Company
is authorized to issue 250,000,000 shares and 10,000,000 shares of common stock and preferred stock, respectively, with a par value of
$ 0.00001 for both common stock and preferred stock.

 At December 31, 2024, the Company had designated 1,150,000 shares,
 10,000 shares, 2,700,000 shares, and 10,000 shares of Series Seed Preferred Stock, Series A Preferred Stock, Series B Preferred Stock
and Series C Preferred Stock, respectively.

 At December 31, 2023, the Company had designated and authorized the
issuance of up to 1,150,000 shares, 10,000 shares, 2,700,000 shares, and 0 shares of Series Seed Preferred Stock, Series A Preferred Stock,
Series B Preferred Stock and Series C Preferred Stock, respectively.

 Preferred Stock

 Series Seed Convertible Preferred Stock

 The Company has 1,150,000 shares of preferred
stock designated as Series Seed Preferred Stock ("Series Seed") and there are no shares of Series Seed outstanding as of December
31, 2024 and 2023.

 F- 35

 Series A Convertible Preferred Stock

 On September 29, 2023, the Company filed a Certificate
of Designations of Rights and Preferences of Series A Preferred Stock of the Company (the "Series A Certificate of Designations")
with the State of Delaware to designate and authorize the issuance of up to 10,000 shares of Series A Preferred Stock.

 On October 3, 2023, the Company issued 3,000 shares
of Series A Convertible Preferred Stock in exchange for the settlement of $ 3.0 million in notes payable due to Veru, Inc. (see Notes 5
and 7).

 On September 24, 2024, Veru converted all 3,000
shares of Series A Convertible Preferred Stock into 142,749 shares of the Company's common stock per the stated conversion ratio.
There were 0 and 3,000 shares of Series A Convertible Stock outstanding as of December 31, 2024 and 2023, respectively.

 Series B Convertible Preferred Stock

 On December 15, 2023, the Company filed a Certificate
of Designations of Rights and Preferences of Series B Convertible Preferred Stock of the Company (the "Series B Certificate of Designations")
with the State of Delaware to designate and authorize the issuance of up to 2,700,000 shares of Series B Preferred Stock.

 On December 15, 2023, in connection with the PMX
Transaction, as part of the purchase consideration, the Company issued 2,696,729 shares of Series B Convertible Preferred Stock (see Note
5). The Series B Preferred Stock was initially convertible into approximately 6,741,820 shares of the Company's common stock,
upon Stockholder Approval as defined in the Series B Certificate of Designation.

 The Company evaluated the terms of the Series
B Preferred Stock, and in accordance with the guidance of ASC 480, the Series B Preferred Stock was classified as temporary equity in
the accompanying consolidated balance sheets, as the shares may be redeemable by the holders for cash, upon certain conditions that are
not within the control of the Company. Additionally, the Company does not control the actions or events necessary to deliver the number
of required shares upon exercise by the holders of the conversion feature. The Series B Preferred Stock was recorded at its fair value
as of the issuance date (see Note 5). The Series B Preferred Stock was not previously redeemable or probable of becoming redeemable because
it was subject to, among other things, Stockholder Approval as described above, and therefore the carrying amount was not accreted to
its redemption value in prior periods.

 On September 5, 2024, Stockholder Approval was
obtained, and on September 24, 2024, the Company effected the conversion of all 2,696,729 shares of Series B Preferred Stock into 6,741,820
shares of the Company's common stock.

 Series C Convertible Preferred Sock

 On October 1, 2024, the Board of Directors authorized
the Company to create a series of 10,000 shares of preferred stock designated as "Series C Convertible Preferred Stock", with
a par value of $ 0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible
Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock.
The holders of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends
actually paid on shares of Common Stock, when and if actually paid. In addition, from and after the occurrence and during the continuance
of any Triggering Event, dividends ("Default Dividends") will accrue on the Stated Value of each Preferred Share at a rate
of fifteen percent ( 15.0 %) (the "Default Rate") per annum. Each holder is entitled to convert any portion of the outstanding
Preferred Shares held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which
can be determined by dividing (x) the Conversion Amount of such Preferred Share by (y) the Conversion Price, $ 4.5056, subject to adjustment
as provided in the Certificate of Designations.

 F- 36

 After the Stockholder Approval Date, if a Triggering
Event occurs and is continuing at any time after the earlier of the holders' receipt of a Triggering Event Notice and such holder
becoming aware of such Triggering Event (such earlier date, the "Alternate Conversion Right Commencement Date") and ending
on the twentieth (20 th) Trading Day after the later of (x) the date of such Triggering Event is cured and (y) such holder's
receipt of a Triggering Event Notice (such ending date, the "Alternate Conversion Right Expiration Date"), and each such period,
an "Alternate Conversion Right Period"), such holder may, at such holder's option, by delivery of a Conversion Notice
to the Company (the date of any such Conversion Notice, each an "Alternate Conversion Date"), convert all, or any number of
Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an "Alternate Conversion").
Alternate Conversion Price means, with respect to any Alternate Conversion that price will be the lowest of (i) the applicable Conversion
Price as in effect on the applicable Conversion Date of the applicable Alternate Conversion, and (ii) the greater of (x) the Floor Price
and (y) 80% of the lowest VWAP of the Common Stock during the five (5) consecutive Trading Day period ending and including the Trading
Day immediately preceding the delivery or deemed delivery of the applicable Conversion Notice (such period, the "Alternate Conversion
Measuring Period").

 At any time, the Company has the right to redeem
in cash all, but not less than all, of the Preferred Shares then outstanding at a price (the "Company Optional Redemption Price")
equal to 125% of the greater of (i) the Conversion Amount being redeemed and (ii) the product of (1) the Conversion Rate with respect
to the Conversion Amount being redeemed multiplied by (2) the greatest closing sale price of the Company's Common Stock on any Trading
Day during the period commencing on the date immediately preceding the date the Company notifies the holders of its elections to redeem
and the date the Company makes the entire payment required. Upon the occurrence of a Bankruptcy Triggering Event, the Company will immediately
redeem, in cash, each of the Preferred Shares then outstanding at a redemption price equal to the greater of (i) the product of (A) the
Conversion Amount to be redeemed multiplied by (B) 125% and (ii) the product of (X) the Conversion Rate with respect to the Conversion
Amount in effect immediately following the date of initial public announcement of such Bankruptcy Triggering Event multiplied by (y) the
product of (1) 125% multiplied by (2) the greatest closing sale price of the Common Stock on any Trading Day during the period commencing
on the date immediately preceding such Bankruptcy Triggering Event and ending on the date the Company pays the entire payment required.
The holders of the Series C Preferred Stock are entitled to be paid a cash amount equal to 30% of the gross proceeds in the event of any
sale of common stock under the ELOC in accordance with the terms stated below within the ELOC securities purchase agreement.

 In no event may any Preferred Shares be converted
(or Warrants be exercised) and shares of Common Stock be issued to any holder if after giving effect to the issuance of shares of Common
Stock upon such conversion of the Preferred Shares (or exercise of the Warrants), the holder (together with its affiliates, if any) would
beneficially own more than 4.99 % of the outstanding shares of Common Stock, which we refer to herein as the "PIPE Blocker".
The PIPE Blocker may be raised or lowered to any percentage not in excess of 9.99 % at the option of the applicable holder of the Preferred
Shares (or Warrants), except that any raise will only be effective upon 61-days' prior notice to the Company.

 F- 37

 Securities Purchase Agreement and ELOC

 On October 2, 2024, the Company entered into a
Securities Purchase Agreement (the "Securities Purchase Agreement") with six institutional and accredited investors. The Company
sold an aggregate of i) 3,499 Series C Preferred Stock, par value $ 0.00001 per share (the "Series C Redeemable Preferred
Stock"), and (ii) a warrants to purchase 591,856 shares of common stock (the "Series C PIPE Warrants"), for
aggregate cash proceeds of $ 2,000,000. The Warrants have an exercise price of $ 4.38 per share, subject to adjustment therein, and
expire on the third anniversary of the initial exercisability date. The warrants issued with the Series C Redeemable Preferred Stock are
accounted for as liabilities in accordance with ASC 815.

 Concurrently, on October 2, 2024, the Company
entered into a Common Stock Equity Line of Credit Purchase Agreement (the "ELOC Purchase Agreement") with an institutional
investor, whereby the Company may sell up to $ 25,000,000 of the Company's new issued Common Stock. Pursuant to the ELOC Purchase
Agreement, the investor shall purchase from the Company up to the lesser of (i) $ 25.0 million in shares of our Common Stock and (ii) 1,658,525
shares, representing 19.99 % of the total number of shares of Common Stock outstanding immediately prior to the execution of the ELOC Purchase
Agreement. Pursuant to the ELOC Purchase Agreement, 30 % of the gross proceeds to the Company from any sale of common stock thereunder
must be applied towards the redemption of the Series C Redeemable Preferred Stock.

 Based on the terms of
the Series C Redeemable Preferred Stock and the Company's Certificate of Designation, and in accordance with ASC 480, the Series
C Redeemable Preferred Stock is accounted for as mezzanine equity due to the contingent redemption feature upon any sale of common
stock under the ELOC Purchase Agreement. The initial cash proceeds of $ 2,000,000 were allocated between the Series C Preferred Stock
and derivative liability warrants, with the amount initially recorded in mezzanine equity based on the guidance in ASC 815 (i.e. the value
of the derivative liability warrant is allocated its full fair value, and the residual is allocated to the Series C Redeemable Preferred
Stock). The derivative liability warrants were measured at fair value at inception in the amount of $ 1,138,476 and the Series C Redeemable
Preferred stock was measured at residual value of $ 861,524. The Series C Redeemable Preferred Stock is subsequently measured at redemption
value as they occur, with the difference between the basis per share of $ 246.22 and redemption value per share recorded as a deemed dividend
in the statements of operations.

 During the year ended
December 31, 2024, the Company received proceeds of $ 935,625 and recorded approximately $ 250,000 of shareholder receivable under the ELOC
and the Company recorded a deemed divided in the amount of $ 206,404 in the statements of operations for the year ended December 31, 2024.

 The Company did not have
the Series C PIPE warrant liabilities at December 31, 2023. The following table presents information about the Company's Series
C PIPE warrant liabilities that are measured at fair value on a recurring basis with changes in fair value presented in the statements
of operations:

 Description

 Level

2024

 Contingent warrant liabilities – Series C PIPE warrants*

 $
 32,892

 Total

 $
 32,892

 *
 Included within contingent warrant liabilities of the accompanying
consolidated balance sheet as of December 31, 2024.

 The following table presents the changes in the
fair value of the Series C PIPE warrants:

 Series C

PIPE

warrants*

 Fair value as of October 2, 2024 (inception)

 $
 1,138,476

 ( 1,105,584
)

 Fair value as of December 31, 2024

 $
 32,892

 *
 Included within Change in Fair Value of Contingent Warrant
Liabilities in the accompanying consolidated statement of operations for the year ended December 31, 2024.

 The following table provides quantitative information
regarding the fair value measurements for the derivative liability warrants using the Monte Carlo pricing model:

 At Inception

2024

 Strike price

 $
 4.38

 $
 4.38

 Expected annual volatility

 %

 %

 Risk-free rate

 3.55
 %

 4.31
 %

 Expected term, years

 3.50

 3.25

 There were no transfers in or out of
Level 3 from other levels in the fair value hierarchy during the year ended December 31, 2024.

 F- 38

 Common Stock

 As of December 31, 2024 and 2023 there were 11,767,443
and 571,033 shares of common stock issued, respectively, and 11,754,509 and 558,099 shares of common stock outstanding, respectively.

 Warrant Inducements:

 July 2024 Inducement

 On July 11, 2024, the Company entered into common
stock preferred investment options exercise inducement offer letters (the "Inducement Letters") with certain holders of existing
preferred investment options to purchase shares of the Company's common stock at the original exercise prices of $ 101.84 and $ 43.60
per share, issued on August 11, 2022 and August 2, 2023, respectively (collectively, the "Existing PIOs"), pursuant to which
the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 186,466 shares of the Company's common stock,
at a reduced exercise price of $ 6.00 per share, in consideration for the Company's agreement to issue new preferred investment options
(the "Inducement PIOs") to purchase up to an aggregate of 559,397 shares of the Company's common stock. Of the 559,397
PIOs issued, 186,465 have a contractual term of 5 years, while the remaining 372,932 have a contractual term of 2 years. Aside from the
contractual terms, the Inducement PIOs have substantially the same terms as the Existing PIOs.

 On July 11, 2024, the Company consummated the
transaction contemplated by the Inducement Letters upon unanimous written consent of the Board of Directors (the "Warrant Inducement").
The Company received aggregate net proceeds of approximately $ 0.9 million from the Warrant Inducement, after deducting placement agent
fees and other offering expenses payable by the Company.

 The Company agreed to file a registration statement
covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs (the "Resale Registration
Statement") within 30 days after the date of the Inducement Letter and to use commercially reasonable efforts to cause such Resale
Registration Statement to be declared effective by the SEC within 60 days following the date of the Inducement Letter (or within 90 days
following the date of the Inducement Letter in the case of full review of the Resale Registration Statement by the SEC).

 The Company engaged H.C. Wainwright & Co.,
LLC ("Wainwright") to act as its exclusive placement agent in connection with the transactions summarized herein and paid
Wainwright a cash fee equal to 7.5 % of the gross proceeds received form the exercise of the Existing PIOs as well as a management fee
equal to 1.0 % of the gross proceeds from the exercise of the Existing PIOs. The Company also agreed to reimburse Wainwright for its expenses
in connection with the exercise of the Existing PIOs and the issuance of the Inducement PIOS, up to $ 50,000 for fees and expenses of legal
counsel and other out-of-pocket expenses and paid Wainwright for non-accountable expenses in the amount of $ 35,000. The Company also issued
to Wainwright or its designees warrants (the "Placement Agent Warrants"), and as such shares of common stock issuable thereunder,
(the "Placement Agent Warrant Shares") to purchase (i) 13,054 shares of common stock which have the same terms as the Inducement
PIOs except for an exercise price equal to $ 7.50 per share and a term of five (5) years following the date of stockholder approval and
(ii) upon any exercise for cash of the Inducement PIOs, 7.5 % of the aggregate exercise price and that number of shares of common stock
equal to 7.0 % of the aggregate number of such shares of common stock underlying the Inducement PIOs that have not been exercised, which
will have substantially the same terms as the Placement Agent Warrants.

 The Company evaluated the terms of the Inducement
PIOs and the Wainwright Inducement Warrants (collectively, the "August 2023 Inducement Warrants"), and determined that they
should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40.

 The Warrant Inducement, which resulted in the
lowering of the exercise price of the Existing PIOs and the issuance of the Inducement PIOs, is considered a modification of the Existing
PIOs under the guidance of Accounting Standards Update ("ASU") No. 2021-04, Issuer's Accounting for Certain Modifications
or Exchanges of Equity Classified Written Call Options. The modification is consistent with the "Equity Issuance" classification
under that guidance as the reason for the modification was to induce the holders of the Existing PIOs to cash exercise their warrants,
resulting in the imminent exercise of the Existing PIOs, which raised equity capital and generated net proceeds for the Company of approximately
$ 0.9 million. As the Existing PIOs and the Inducement PIOs were classified as equity instruments before and after the exchange, and as
the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of approximately $ 1.9
million as an equity issuance cost.

 In addition, the change in fair value of the contingent
warrant liability associated with 3,729 of the August 2022 Contingent Warrants and 7,459 of the August 2023 Contingent Warrants was decreased
to $ 0 upon the agreement with Wainwright that all prior contingent warrants were no longer issuable or due upon the Warrant Inducement
Transaction. The fair value of the contingent warrant liability of approximately $ 2,700 was derecognized as of the settlement date, with
the corresponding amount, representing the fair value of the Wainwright Inducement Warrants, was recognized as additional paid-in capital.

 The Company evaluated the terms of the 39,158
Inducement Contingent Warrants (equivalent to 7.0 % of the aggregate number of such shares of common stock underlying the Inducement PIOs
that have not been exercised), which are issuable upon a future inducement, and determined that they should be classified as a liability
based upon accounting guidance provided in ASC 815-40. Since the Inducement Contingent Warrants are a form of compensation to Wainwright,
the Company recorded the value of the liability of approximately $ 158,000 as a reduction of additional paid in capital, with subsequent
changes in the value of the liability recorded in other income (expense) in the accompanying statements of operations. The fair value
was determined using a Monte-Carlo option pricing model, and as of December 31, 2024 and 2023

 F- 39

 August 2023 Inducement

 On July 31, 2023, the Company entered into a common
stock preferred investment option exercise inducement letter (the "Inducement Letter") with a certain holder of existing preferred
investment options to purchase shares of the Company's common stock at the original exercise price of $ 101.84 per share, issued
on August 11, 2022 (the "Existing PIOs"). Pursuant to the Inducement Letter, the Holder agreed to exercise for cash its Existing
PIOs to purchase an aggregate of 62,155 shares of the Company's common stock (the "Inducement PIO Shares"), at a reduced
exercise price of $ 43.6 per share, in exchange for the Company's agreement to issue new PIOs (the "Inducement PIOs")
to purchase up to 124,311 shares of the Company's common stock. The Inducement PIOs have substantially the same terms as the Existing
PIOs.

 On August 2, 2023, the Company consummated the
transactions contemplated by the Inducement Letter (the "Warrant Inducement"). The Company received aggregate net proceeds
of approximately $ 2.3 million from the Warrant Inducement, after deducing placement agent fees and other offering expenses payable by
the Company.

 Upon close of the transaction, the Company issued
the Holder 39,375 of the 62,155 shares of common stock that were issuable upon exercise of the Existing PIOs. Due to the beneficial ownership
limitation provisions in the Inducement Letter, the remaining 22,780 shares were initially unissued, and held in abeyance for the benefit
of the Holder until notice from the Holder that the shares may be issued in compliance with such limitation is received. These shares
were issued to the Holder in October 2023.

 The Company agreed to file a registration statement
covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs, as soon as practicable,
and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC within 90 days following
the date of the Inducement Letter, and to keep the Resale Registration Statement effective at all times until there are no Inducement
PIO Shares. The provision to register the underlying shares in the Warrant Inducement does not require payment related to the registration
rights provided. As such, while the shares were not registered within 90 days of the date of the Inducement Letter, there is no accounting
impact for this provision.

 The Company engaged Wainwright to act as its placement
agent in connection with the Warrant Inducement and paid Wainwright a cash fee equal to 7.5 % of the gross proceeds received from the exercise
of the Existing PIOs as well as a management fee equal to 1.0 % of the gross proceeds from the exercise of the Existing PIOs. The Company
also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement
PIOs, up to $ 50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable
expenses in the amount of $ 35,000. In addition, the exercise for cash of the Existing PIOs triggered the issuance to Wainwright or its
designees, warrants to purchase 3,729 shares of common stock ("Wainwright Inducement Warrants"), which were issuable in accordance
with the terms of the August Contingent Warrants, and have the same terms as the Inducement PIOs except for an exercise price equal to
$ 54.50 per share. The Company also agreed to issue warrants to Wainwright upon any exercise for cash of the Inducement PIOs, that number
of shares of common stock equal to 6.0 % of the aggregate number of such shares of common stock underlying the Inducement PIOs that have
been exercised, also with an exercise price of $ 54.50 (the "Inducement Contingent Warrants"). The maximum number of Inducement
Contingent Warrants issuable under this provision is 7,459.

 The Company evaluated the terms of the Inducement
PIOs and the Wainwright Inducement Warrants (collectively, the "August 2023 Inducement Warrants"), and determined that they
should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40. The Company also evaluated
the unissued shares held in abeyance, which represent a prepaid forward contract, and determined that it is an equity instrument based
on the guidance provided in ASC 480 and ASC 815-40.

 The Warrant Inducement, which resulted in the
lowering of the exercise price of the Existing PIOs and the issuance of the Inducement PIOs, is considered a modification of the Existing
PIOs under the guidance of Accounting Standards Update ("ASU") No. 2021-04, Issuer's Accounting for Certain Modifications
or Exchanges of Equity Classified Written Call Options. The modification is consistent with the "Equity Issuance" classification
under that guidance as the reason for the modification was to induce the holders of the Existing PIOs to cash exercise their warrants,
resulting in the imminent exercise of the Existing PIOs, which raised equity capital and generated net proceeds for the Company of approximately
$ 2.3 million. As the Existing PIOs and the Inducement PIOs were classified as equity instruments before and after the exchange, and as
the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of approximately $ 2.6
million as an equity issuance cost.

 In addition, the change in fair value of the contingent
warrant liability associated with 3,729 of the August Contingent Warrants that were settled through issuance of the Wainwright Inducement
Warrants, of approximately $ 122,000, was recognized in other income(expense) in the accompanying statements of operations, and the fair
value of the contingent warrant liability of approximately $ 129,000 was derecognized as of the settlement date. The corresponding amount,
representing the fair value of the Wainwright Inducement Warrants, was recognized as additional paid in capital.

 The Company evaluated the terms of the Inducement
Contingent Warrants and determined that they should be classified as a liability based upon accounting guidance provided in ASC 815-40.
Since the Inducement Contingent Warrants are a form of compensation to Wainwright, the Company recorded the value of the liability of
approximately $ 26,000 as a reduction of additional paid in capital, with subsequent changes in the value of the liability recorded in
other income (expense) in the accompanying statements of operations.

 F- 40

 Treasury Stock

 On November 10, 2022, the Board approved a stock
repurchase program (the "Repurchase Program") to allow the Company to repurchase up to 125,000 shares of common stock with
a maximum price of $ 1.00 per share, with discretion to management to make purchases subject to market conditions. On November 18, 2022,
the Board approved an increase to the maximum price to $ 2.00 per share. There was no expiration date for this program and prices are not
adjusted for the reverse stock split to comply with the program.

 There were no repurchases of common stock during
the year ended December 31, 2024. During the year ended December 31, 2023, the Company repurchased 1,441 shares of common stock, for an
aggregate of approximately $ 59,000, at an average price of $ 40.80 (adjusted on a post-reverse stock split basis). Shares that are repurchased
are classified as treasury stock pending future use and reduce the number of shares outstanding used in calculating earnings per share.

 On November 13, 2024, the Board terminated the
Repurchase Program.

 At the Market Offering Agreement

 On March 29, 2023, the Company entered into an
At The Market Offering Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC, as sales agent (the "Agent"),
to create an at-the-market equity program under which it may sell up to $ 3,900,000 of shares of the Company's common stock (the
"Shares") from time to time through the Agent (the "ATM Offering"). Under the ATM Agreement, the Agent will be
entitled to a commission at a fixed rate of 3.0 % of the gross proceeds from each sale of Shares under the ATM Agreement. The Company has
no obligation to sell, and the Agent is not obligated to buy or sell, any of the Shares under the Agreement and may at any time suspend
offers under the Agreement or terminate the Agreement. The ATM Offering will terminate upon the termination of the ATM Agreement
as permitted therein.

 Deferred offering costs associated with the ATM
Agreement are reclassified to additional paid in capital on a pro-rata basis when the Company completes offerings under the ATM Agreement.
Any remaining deferred costs will be expensed to the statements of operations should the planned offering be abandoned.

 As of December 31, 2024, no shares have been sold
under the ATM Offering, and the Company wrote off approximately $ 0.3 million of deferred offering costs in its consolidated balance sheets
as of December 31, 2024.

 F- 41

 Warrants

 The following summarizes activity related to the
Company's outstanding warrants, excluding contingent warrants issuable upon exercise of the preferred investment options, for the
years ended December 31, 2024 and 2023:

 Remaining

 Contractual

 Exercise

 Life

 Price

 (in years)

 Outstanding as of December 31, 2022

 147,773

 $
 94.8

 4.7

 128,040

 44.0

 -

 Exercised

 ( 78,321
)

 34.6

 -

 Cancelled

 -

 -

 -

 Outstanding as of December 31, 2023

 197,492

 $
 67.20

 4.3

 1,318,334

 4.59

 -

 Exercised

 ( 340,493
)

 34.53

 -

 Cancelled

 -

 -

 -

 Outstanding as of December 31, 2024

 1,175,333

 6.72

 2.92

 Warrants vested and exercisable as of December 31, 2024

 583,475

 $
 9.10

 2.57

 As of December 31, 2024, the Company had outstanding
warrants, which are exercisable into 583,475 shares of common stock. The shares of common stock underlying the warrants outstanding had
an exercise price of $ 6.72 per share, based on the closing trading price on December 31, 2024.

 Contingent Warrant Liabilities

 Additionally, as of December 31, 2024, the fair
value of contingent warrant labilities includes the Series C PIPE warrants (see Note 9) of $ 32,982 and those issuable upon exercise of
the Inducement PIOs of approximately $ 10,200 (see Note 9) totaling $ 43,089 included as contingent warrant liabilities in the accompanying
consolidated balance sheets.

 As of December 31, 2023, the fair value of contingent
warrants issuable upon exercise of the August 2022 private placement and August 2023 inducement warrants was approximately $ 3,000. Upon
the PIO inducement in July 2024, the August 2022 and August 2023 contingent warrants were settled and replaced for no consideration.

 The maximum number of warrants issuable upon settlement
of the contingent warrants was 39,158 for the Inducement PIOs contingent warrants and 591,856 for the Series C PIPE warrants as of December
31, 2024. The maximum number of warrants issuable upon settlement of the Inducement contingent warrants was 11,188 as of December 31,
2023.

 Onconetix Equity Incentive Plans

 The Company's 2019 Equity Incentive Plan
(the "2019 Plan") was adopted by its board of directors and by its stockholders on July 1, 2019. On February 23, 2022 the
Company's board of directors adopted the Company's 2022 Equity Incentive Plan (the "2022 Plan"), which is the
successor and continuation of the Company's 2019 Plan. Under the 2022 Plan, the Company may grant stock options, restricted stock,
restricted stock units, stock appreciation rights, and other forms of awards to employees, directors, and consultants of the Company.
In May 2023, the number of shares of common stock reserved for issuance under the 2022 Plan was increased to 78,750, and in September
2024, the number of shares of common stock reserved for issuance under the 2022 Plan was increased to 1,450,000. Stock-based awards granted
during the year ended December 31, 2024 and 2023 were all granted under the 2022 Plan. As of December 31, 2024, there are 719,660 shares
available for issuance under the 2022 Plan.

 F- 42

 Stock Options

 The following summarizes activity related to
the Company's stock options under the 2019 Plan and the 2022 Plan for the years ended December 31, 2024 and 2023:

 Remaining

 Total

 Contractual

 Exercise

 Intrinsic

 Life

 Price

 Value

 (in years)

 Outstanding as of December 31, 2022

 34,816

 $
 132.0

 $
 670,161

 8.2

 24,054

 19.2

 —

 —

 Forfeited / cancelled

 ( 10,103
)

 194.80

 —

 —

 Exercised

 ( 1,148
)

 0.4

 1,148

 —

 Outstanding as of December 31, 2023

 47,619

 65.20

 94,239

 8.4

 —

 —

 —

 —

 Forfeited / cancelled

 ( 33,539
)

 28.35

 —

 —

 Exercised

 ( 406
)

 0.5

 2,512

 —

 Outstanding as of December 31, 2024

 13,674

 156.96

 —

 7.87

 Options vested and exercisable as of December 31, 2024

 9,336

 $
 189.15

 7.65

 There were no stock options granted during the
year ended December 31, 2024. The fair value of options granted during the year ended December 31, 2023 was estimated using the following
assumptions:

 For the Year
 Ended December 31,

 2023

 Exercise price

 $
 10.40 – 51.60

 Term (years)

 5.00 – 10.00

 Expected stock price volatility

 101.1 % – 119.5
 %

 Risk-free rate of interest

 3.5 % – 4.7
 %

 The weighted average grant date fair value of
stock options granted during the year ended December 31, 2023 was $ 16.40. The aggregate fair value of stock options that vested during
the years ended December 31, 2024 and 2023 was approximately $ 0.7 million and $ 0.7 million, respectively.

 On October 4, 2023, the Company's board
of directors granted an aggregate of 17,744 stock options in connection with the appointment of the Company's newly hired Chief
Executive Officer and Chief Financial Officer. The options granted have an exercise price of $ 17.22 per share, vest quarterly over
a three-year period, and have a grant date fair value of approximately $ 0.2 million. The Company recognized less than $ 0.1 million of
stock-based compensation expense related to these awards during the year ended December 31, 2023. Subsequent to December 31, 2023, in
connection with the resignation of the newly hired Chief Executive Officer, 12,199 of these options were forfeited.

 F- 43

 Restricted Stock

 On May 9, 2023, the Board's Compensation
Committee approved the issuance of restricted stock, granted under the Company's 2022 Plan, to the Company's executive officers,
employees, and certain of the Company's consultants. The restricted shares granted totaled 12,188, of which 3,750, 1,875, and 3,750
were granted to the Company's former CEO, former CFO, and former CBO, respectively. All of the restricted shares granted vest as
follows: 50 % in January 2024, 25 % in August 2024, and 25 % in August 2025. In addition, on May 31, 2023, the Board's Compensation
Committee approved the issuance of 636 shares of restricted stock, granted to the Company's non-executive Board members, with full
vesting on May 31, 2024. On February 14, 2024, in connection with the appointment of a non-executive Board member, the Company issued
 78 shares of restricted stock, which vested in full on June 14, 2024. Furthermore, on September 26, 2024, the Company issued its
Board members a total of 16,590 restricted stock, with full vesting August 31, 2025.

 Grant Date

 Fair Value

 Nonvested as of December 31, 2023

 6,414

 $
 41.20

 700,124

 0.42

 Vested

 ( 688,308
)

 0.62

 Forfeited

 ( 313
)

 40.93

 Nonvested as of December 31, 2024

 17,917

 $
 6.15

 Proteomedix Stock Option Plan

 Proteomedix sponsors a stock option plan (the
"PMX Option Plan") which provides common stock option grants to be granted to certain employees and consultants, as was determined
by the board of directors of Proteomedix. In connection with the PMX Transaction, the Company assumed the PMX Option Plan (see Note 5).

 Generally, options issued under the PMX Option
Plan have a term of less than 11 years and provide for a four -year vesting period during which the grantee must remain in the service
of Proteomedix. Stock options issued under the PMX Option Plan are measured at fair value using the Black-Scholes option pricing model.

 On April 16, 2024, the board of directors of Proteomedix
approved a two-year extension of 12,257 vested stock options that were set to expire in April 2024. The extended expiration date for these
options is April 18, 2026. The Company recorded approximately $ 18,000 of expense associated with this modification during the year ended
December 31, 2024.

 There was no other activity under the PMX Option
Plan for the year ended December 31, 2024. In October 2024, 58,172 stock options were converted to shares with a weighted average exercise
price of $ 3.46. As of December 31, 2024, there were no outstanding stock options.

 Stock-Based Compensation

 Stock-based compensation expense for the years ended December 31, 2024
and 2023 was as follows:

 2024

 2023

 Selling, general and administrative

 $
 483,226

 $
 234,298

 Research and development

 ( 44,573
)

 95,462

 Total

 $
 438,653

 $

 During the year ended December 31, 2024, in connection
with the termination of three Company employees, outstanding stock options and restricted stock awards to these individuals were modified
to allow continued vesting during the term of their respective new consulting agreements. The Company recognized a net credit of approximately
$ 58,000 to stock-based compensation expense as a result of these modifications, primarily due to the decrease in the Company's
stock price.

 F- 44

 Note 10 — Commitments and Contingencies

 Leases

 The Company entered into a short-term lease in
Palm Beach, Florida with an unrelated party, with a commencement date of May 1, 2022, for approximately $ 14,000 per month. The lease,
which was personally guaranteed by the Company's former CEO, ended on April 30, 2023. During the year ended December 31, 2023, the
Company incurred rent expense on this lease of approximately $ 51,000, and variable lease expense of approximately $ 4,000.

 Proteomedix leases office and lab space in Zurich
Switzerland. On April 1, 2024, the original lease was amended to add additional office and laboratory space. The lease amendment was
accounted for as a separate lease, resulting in an additional right-of-use asset and lease liability of approximately $ 88,000. The lease,
as amended, requires payments of approximately $ 129,000 for the year ended December 31, 2025.

 Litigation

 From time to time, the Company may be subject
to various legal proceedings and claims that arise in the ordinary course of its business activities. As of December 31, 2024, the Company
is not a party to any material legal proceedings and is not aware of any pending or threatened claims. However, as discussed in Note 5,
on December 21, 2023, the Company filed a notice with the Bankruptcy Court terminating the WraSer APA and the WraSer MSA, after having
determined that a Material Adverse Effect had occurred. WraSer has advised the Company that it does not believe that a Material Adverse
Effect occurred, and they recently filed a plan of reorganization that indicates it may seek damages from the Company due to the termination
of the WraSer APA and WraSer MSA.

 Registration Rights Agreements

 In connection with private placements consummated
in April 2022 and August 2022, the Company entered into Registration Rights Agreements with the purchasers. Upon the occurrence of any
Event (as defined in each Registration Rights Agreement), which, among others, prohibits the purchasers from reselling the securities
for more than ten consecutive calendar days or more than an aggregate of fifteen calendar days during any 12-month period, and should
the registration statement cease to remain continuously effective, the Company would be obligated to pay to each purchaser, on each monthly
anniversary of each such Event, an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of 2.0 % multiplied
by the aggregate subscription amount paid by such purchaser in the private placements. As of December 31, 2024, and as a result of the
consummation of the remaining warrants associated with the April 2022 and August 2022 private placements, the Company has no further obligations
pertaining to the Registration Rights Agreements.

 Indemnification

 In the normal course of business, the Company
enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications.
The Company's exposure under these agreements is unknown because it involves claims that may be made against the Company in the
future but have not yet been made. To date, the Company has not been required to defend any action related to its indemnification obligations.
However, during the third quarter of 2023, the Company received a claim from its former CEO and a former accounting employee requesting
advancement of certain expenses. The Company recorded approximately $ 209,000 in related expenses during the year ended December 31, 2023,
of which approximately $ 159,000 was paid through reduction of the outstanding related party receivable due from the former CEO (see Note
11). The Company recorded a related accrual of approximately $ 50,000, which was included in accrued expenses at December 31, 2023, and
which was paid during 2024, and accordingly there is no related accrual as of December 31, 2024. The maximum potential amount of future
payments the Company could be required to make under these indemnification agreements is not estimable at this time.

 F- 45

 Note 11 — Related Party Transactions

 During 2022, the Company entered into a lease
agreement that was personally guaranteed by the Company's former CEO. The lease expired on April 30, 2023 (see Note 10).

 During the year ended December 31, 2023, the Company's
Audit Committee completed a review of the Company's expenses due to certain irregularities identified with regards to the related
party balance. Based on the results of the review, it was determined that the Company paid and recorded within selling, general and administrative
expenses, personal expenditures of the Company's former CEO and an accounting employee who was also the former CEO's assistant,
during 2022 and during the first three quarters of 2023. The Company evaluated the receivable, which was approximately $ 363,000, after
recording a recovery of approximately $ 159,000, and which represented the total of the items identified as personal in nature for which
the Company did not anticipate recovery from the related party. During 2023, the Company recorded a corresponding reserve for the full
amount, resulting in a net related party receivable balance of $0 as of December 31, 2024 and December 31, 2023.

 On December 18, 2023, the Company entered into
the Subscription Agreement with the PMX Investor, a 5 % stockholder of the Company as of December 31, 2024 (see Note 8). During the year
ended December 31, 2024, the Company issued a non-convertible debenture in the principal amount of $ 5.0 million to the PMX Investor, in
connection with the Subscription Agreement and has settled the principal and accrued interest through the issuance of shares (see Notes
7 and 8).

 On February 6, 2024, the Company appointed Thomas
Meier, PhD, as a member of the Company's board of directors. Dr. Meier provides consulting services to Proteomedix, through a consulting
agreement that was effective January 4, 2024. The Company recorded approximately $ 58,000 in related expenses during the year ended December
31, 2024, of which approximately $ 0 is included in accounts payable in the accompanying consolidated balance sheets as of December 31,
2024.

 F- 46

 Note 12 — Income Taxes

 The components of loss before income taxes are as follows:

 2024

 2023

 U.S.

 $
 ( 58,988,309
)

 $
 ( 37,106,599
)

 Foreign

 ( 747,894
)

 ( 315,688
)

 Total loss before income taxes

 $
 ( 59,736,203
)

 $
 ( 37,422,287
)

 The Company's major tax jurisdictions are
the United States, Switzerland, and various state jurisdictions, and the Company does not have any pending tax audits. The income tax
benefit recorded for the years ended December 31, 2024 and December 31, 2023 related to the Company's deferred foreign taxes. Generally,
the Company's federal returns from 2019 on and state returns from 2018 on, and foreign returns from 2018 on, are subject to examination
by the United States, state, and foreign tax authorities; however, to the extent allowed by law, tax authorities have the ability to adjust
the Company's carryforwards of unutilized net operating losses and research and development credits for all years.

 At December 31, 2024, the Company had a net operating
loss ("NOL") carryforward for federal, foreign, and state income tax purposes totaling approximately $ 42.8 million, $ 15.2
million, and $ 35.7 million, respectively, available to reduce future taxable income. The federal NOL and certain state NOLs of $ 28.6 million
are carried forward indefinitely subject to a limitation of 80 % of taxable income. State NOLs of approximately $ 15.2 million will begin
to expire in 2024 if not utilized, and foreign NOLs of approximately $ 7.1 million will begin to expire in 2024 if not utilized.

 The NOL carry forward is subject to review and
possible adjustment by the Internal Revenue Service and state tax authorities. Under the Internal Revenue Code ("IRC") Sections
382 and 383, annual use of the Company's net operating loss carryforwards and research credit carryforwards to offset taxable income
and tax, respectively, may be limited based on cumulative changes in ownership. The Company has not completed an analysis to determine
whether any such limitations have been triggered as of December 31, 2024. The amount of the annual limitation, if any, will be determined
based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation
in future years.

 The tax effects of the temporary differences and
carryforwards that give rise to deferred tax assets and liabilities consist of the following:

 As of

 2024

 2023

 Deferred tax assets:

 Net-operating loss carryforward

 $
 13,309,416

 $
 10,214,760

 Intangibles

 3,887,855

 3,349,919

 Capitalized research and development

 1,001,916

 1,171,320

 645,113

 690,760

 Deposit on WraSer APA

 854,896

 854,896

 Accrued compensation

 55,193

 150,099

 License agreement

 45,493

 49,157

 Other

 667,065

 520,207

 Gross deferred tax assets

 20,466,947

 17,001,118

 Valuation allowance

 ( 20,441,833
)

 ( 15,697,701
)

 Deferred tax assets, net of allowance

 $
 25,114

 $
 1,303,417

 Deferred tax liabilities:

 Intangible assets

 -

 ( 4,345,449
)

 Fixed assets

 ( 1,378
)

 ( 2,560
)

 Other

 ( 23,736
)

 ( 29,189
)

 Total deferred tax liabilities

 $
 ( 25,114
)

 $
 ( 4,377,198
)

 Net deferred tax liability

 $
 -

 $
 ( 3,073,781
)

 F- 47

 Note 12 — Income Taxes (cont.)

 The Company has evaluated the positive and negative
evidence bearing upon the realizability of its deferred tax assets. The Company has recorded a valuation allowance against its United
States and foreign deferred tax assets in each of the years ended December 31, 2024 and 2023, because the Company's management believes
that it is more likely than not that these assets will not be realized. During the years ended December 31, 2024 and 2023, the valuation
allowance increased by approximately $ 4.7 million and $ 11.2 million, respectively.

 The provision for income taxes on earnings subject
to income taxes differs from the statutory Federal rate at December 31, 2024 and 2023, due to the following:

 2024

 2023

 Expected income tax benefit at Federal statutory tax rate

 $
 ( 12,488,416
)

 $
 ( 7,858,680
)

 State and local taxes, net of Federal tax benefit

 ( 339,155
)

 ( 1,192,605
)

 Research credits

 ( 37,810
)

 —

 Foreign NOL expirations

 —

 315,927

 29,088

 196,025

 Subscription agreement liability

 684,390

 181,440

 Officer's compensation

 —

 ( 126,337
)

 Acquisition related costs

 10,500

 164,073

 Goodwill Impairment

 6,792,870

 —

 Permanent items

 ( 244,395
)

 55,486

 State rate adjustment

 —

 ( 23,135
)

 Foreign rate differential

 7,205

 —

 Currency translation adjustment

 49,773

 —

 Other

 ( 253,362
)

 60,599

 Change in valuation allowance

 4,744,132

 8,214,614

 Income tax benefit

 $
 ( 1,045,180
)

 $
 ( 12,593
)

 Under U.S. GAAP, the impact of an uncertain income
tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit
by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, U.S. GAAP provides guidance on derecognition, classification, interest and penalties, accounting for interim
periods, disclosure, and transition.

 A reconciliation of the beginning and ending amount of unrecognized
tax benefits is as follows:

 2024

 2023

 Beginning balance

 $
 17,010

 $
 17,010

 Increases related to prior year tax positions

 —

 —

 Increases related to current year tax positions

 9,452

 —

 Ending balance

 $
 26,462

 $
 17,010

 At December 31, 2024 and 2023, the Company's
unrecognized tax benefits were $ 26,462 and $ 17,010, respectively. Due to the existence of the valuation allowance, future changes in the
Company's unrecognized tax benefits will not impact the effective tax rate. The Company does not expect its unrecognized tax benefits
to change significantly over the next 12 months.

 The Company's policy is to recognize interest
and penalties related to uncertain tax positions in income tax expense. As of December 31, 2024 and 2023, there were no accrued interest
and penalties associated with uncertain tax positions.

 F- 48

 Note 13 — Net Loss Per Share

 Basic net loss per share is computed by dividing
the net income or loss applicable to common shares by the weighted average number of common shares outstanding during the period. The
weighted average number of shares of common stock outstanding includes pre-funded warrants because their exercise requires only nominal
consideration for delivery of shares; it does not include any potentially dilutive securities or any unvested restricted shares of common
stock. Certain restricted shares, although classified as issued and outstanding at December 31, 2024, are considered contingently returnable
until the restrictions lapse and will not be included in the basic net loss per share calculation until the shares are vested. Unvested
shares of the Company's restricted stock do not contain non-forfeitable rights to dividends and dividend equivalents.

 The two-class method is used to determine earnings
per share based on participation rights of participating securities in any undistributed earnings. Each share of preferred stock that
includes rights to participate in distributed earnings is considered a participating security and the Company uses the two-class method
to calculate net income available to the Company's common stockholders per common share — basic and diluted.

 The following securities were excluded from the
computation of diluted shares outstanding due to the losses incurred in the periods presented, as they would have had an anti-dilutive
impact on the Company's net loss:

 2024

 2023

 Options to purchase shares of common stock

 13,674

 47,619

 Warrants

 1,175,333

 197,492

 Unvested shares of restricted stock

 17,917

 6,414

 Common stock issuable upon conversion of Series A Preferred Stock

 -

 142,749

 Common stock issuable upon conversion of Series C Redeemable Preferred Stock

 776,589

 -

 Total

 1,983,513

 394,274

 Note 14 — Defined Benefit Plan

 Proteomedix sponsors a defined benefit pension
plan (the "Swiss Plan") covering certain eligible employees. The Swiss Plan provides retirement benefits based on years of
service and compensation levels.

 The following significant actuarial assumptions
were used in calculating the benefit obligation and the net periodic benefit cost as of December 31, 2024 and 2023:

2024

2023

 Discount rate

 1.00
 %

 1.45
 %

 Expected long-term rate of return on plan assets

 1.00
 %

 1.45
 %

 Rate of compensation increase

 1.50
 %

 3.00
 %

 Changes in these assumptions may have a material
impact on the plan's obligations and costs.

 The components of net periodic benefit cost
for the year ended December 31, 2024 and for the period from December 15, 2023 to December 31, 2023 are as follows:

 For the year ended

2024

 For the period

 December 15,
 2023

 through December 31,
 2023

 Service cost

 $
 97,964

 $
 4,278

 Interest cost

 30,032

 1,943

 Expected return on plan assets

 ( 23,343
)

 ( 1,581
)

 Amortization of net (gain) loss

 ( 15,346
)

 ( 1,534
)

 Settlements (gain) loss

 -

 ( 1,157
)

 Total

 $
 89,307

 $
 1,949

 During the year ended December 31, 2024 and for
the period ended December 15, 2023 through December 31, 2023, the Company made pension contributions of approximately $ 89,404 and $ 0,
respectively.

 F- 49

 Note 14 — Defined Benefit Plan (cont.)

 The components of accumulated comprehensive loss
attributable to the Company's pension plan for the year ended December 31, 2024 and for the period from December 15, 2023 to December
31, 2023 are as follows:

 For the year ended December 31,

2024

 For the period

December 15,

2023

through

2023

 Net loss (gain)

 $
 ( 190,064
)

 $
 7,277

 Prior service cost (credit)

 ( 63,292
)

 -

 Amortization of net gain

 15,346

 1,534

 Effect of settlement

 -

 1,157

 Other adjustments

 -

 ( 4,005
)

 Total recorded during the period

 $
 ( 238,010
)

 $
 5,963

 As of December 31, 2024 and 2023, the funded status
of the plan and the amounts recognized in the accompanying consolidated balance sheet are as follows:

 2024

 2023

 Projected benefit obligation

 $
 2,593,360

 $
 2,299,970

 Fair value of plan assets

 2,312,481

 1,743,674

 Overfunded (underfunded) status

 $
 ( 280,879
)

 $
 ( 556,296
)

 A reconciliation of the beginning and ending balances
of the accumulated benefit obligation is provided in the table below:

 As of December 31, 2023

 $
 2,299,970

 Service cost

 97,964

 Interest cost

 30,032

 Actuarial (gain) loss

 72,031

 Benefits paid

 ( 20,824
)

 Ordinary contributions paid by employees

 89,404

 Contributions paid by plan participants

 125,553

 Plan amendments

 ( 100,770
)

 Projected benefit obligation as of December 31, 2024

 2,593,360

 Actuarial (gain)/loss due to assumption changes

 ( 37,727
)

 Actuarial (gain)/loss due to plan experience

 109,758

 Accumulated benefit obligation as of December 31, 2024

 $
 2,665,391

 A reconciliation of the beginning and ending balances
of the plan assets is provided in the table below:

 As of December 31, 2023

 $
 1,743,674

 Actual return on plan assets

 285,270

 Contributions paid by employer

 89,404

 Ordinary contributions paid by employees

 89,404

 Contributions paid by plan participants

 125,553

 Benefits paid

 ( 20,824
)

 Settlements

 -

 As of December 31, 2024

 $
 2,312,481

 F- 50

 Note 14 — Defined Benefit Plan (cont.)

 Projected benefit payments for the next five years
as of December 31, 2024 are as follows:

 Years ending December 31,

 2025

 $
 113,000

 2026

 111,000

 2027

 108,000

 2028

 106,000

 2029

 104,000

 Thereafter

 464,000

 Total

 $
 1,006,000

 Note 15 – Segment Information

 The Company conducts its business activities and
reports financial results as one business segment. The presentation of financial results as one reportable segment is consistent with
the way the Company operates its business and is consistent with the manner in which the Chief Operating Decision Maker ("CODM")
evaluates performance and makes resource and operating decisions for the business. The Company's CODM is the Chief Executive Officer.
Furthermore, the Company notes that monitoring financial results as one reportable segment helps the CODM manage costs on a consolidated
basis, consistent with the integrated nature of the operations. The CODM uses net loss, as reported on the Consolidated Statements of
Operations and Comprehensive Loss, in evaluating performance of the Company and determining how to allocate resources of the Company as
a whole. As the CODM evaluates performance on a consolidated basis, all required financial segment information is included in the consolidated
financial statements.

 Geographic Information

 The distribution of revenue by geographical area
was as follows:

 Years Ended

 2024

 2023

 United States

 $
 63,115

 $
 —

 United Kingdom

 23,842

 —

 Switzerland

 2,437,159

 Total

 $
 2,524,116

 $

 The distribution of long-lived assets by geographical
area, which includes property and equipment and the Company's right of use asset, was as follows:

 Years Ended

 2024

 2023

 United States

 $
 5,864

 $
 10,956

 Switzerland

 176,459

 198,240

 Total

 $
 182,323

 $
 209,196

 F- 51

 Note 16 — Subsequent Events

 IQVIA Settlement:

 As previously disclosed
in Current Reports on Form 8-K filed on July 21, 2023 and October 18, 2023, Onconetix, Inc. (the "Company") entered into a
Licensing and Services Master Agreement ("Master Services Agreement") and a related statement of work with IQVIA, Inc. ("IQVIA")
on July 21, 2023, and a second statement of work on July 29, 2023, which were terminated on October 12, 2023. On January 15, 2025, the
Company and IQVIA entered into a Settlement Agreement (the "Settlement Agreement") concerning potential termination payments
under the Master Services Agreement and statements of work. Pursuant to the Settlement Agreement, the Company agreed to pay to IQVIA an
aggregate of $ 150,000 in exchange for a mutual release of all claims in connection with the Master Services Agreement. As a result of
the Settlement Agreement, the Company will record an adjustment of approximately $( 0.9) million in accounts payable.

 Potential Business
Combination:

 On April 8, 2025, the
Company issued a press release announcing the execution of a "Non-Binding Letter of Intent contemplating a potential business combination
transaction with Ocuvex Therapeutics, Inc. ("Ocuvex"), a privately held biopharmaceutical company focused on the development
and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. The
Company and Ocuvex intend to continue negotiations to enter into a definitive agreement. Upon closing of the proposed transaction, the
Company will acquire all the issued and outstanding equity interests of Ocuvex in exchange for newly issued shares of common stock of
the Company. Immediately following the closing of the proposed transaction, the pre-closing Ocuvex equity holders will own approximately
 90 % of the equity interests in the Company.

 ELOC Draws and Series
C Preferred Stock Redemption:

 As of April 15, 2025,
the Company has redeemed approximately 1,369 Series C preferred shares for an aggregate amount of $ 1.71 million. An additional amount
of $ 150,531 is due to the PIPE Series C investors for 120 Series C preferred shares that remain due from the most recent ELOC draw. These
120 shares remain subject to future redemption.

 On May 30, 2025, the
Company has sold approximately 33,256,563 shares under the ELOC Purchase Agreement for aggregate proceeds of approximately $ 5.3 million,
for a total of 36,014,496 shares sold under the ELOC Purchase Agreement for gross proceeds of approximately $ 6.2 million.

 Veru Agreement Waivers:

 On March 31, 2025, Veru
and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024
Promissory Note to April 14, 2025.

 On April 23, 2025, Veru
and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024
Promissory Note to June 30, 2025.

 F- 52

 Exhibit No.

 Description

 2.1

 Share Exchange Agreement, dated December 15, 2023, by and among the Company, Proteomedix, Thomas Meier and the Sellers. (19)

 3.1

 Amended and Restated Certificate of Incorporation filed. (3)

 3.2

 Certificate of Amendment to the Company's Second Amended and Restated Certificate of Incorporation (9)

 3.3

 Certificate of Amendment to the Company's Second Amended and Restated Certificate of Incorporation. (19)

 3.4

 Fourth Amended and Restated Bylaws of the Company. (19)

 3.5

 Certificate
 of Amendment to the Amended and Restated Certificate of Incorporation (12)

 3.6

 Certificate of Amendment to the Amended and Restated Certificate of Incorporation (14)

 3.7

 Certificate of Designations authorizing the issuance of the Series C Preferred Stock (15)

 4.1

 Specimen Common Stock Certificate. (1)

 4.2

 Description of Registered Securities*

 4.3

 Form of Inducement PIO (10)

 4.4

 Form of Altos Warrants (14)

 4.5

 Form of Warrant (15)

 10.1

 2019 Equity Incentive Plan. (1)

 10.2

 2022 Equity Incentive Plan. (8)

 10.3

 2019 Equity Incentive Plan Form of Stock Option Grant Agreement. (1)

 10.4

 2022 Equity Incentive Plan Form of Incentive Stock Option Agreement (Employee). (24)

 10.5

 2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Consultant). (24)

 10.6

 2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Non-Employee Director). (24)

 10.7

 2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Employee). (24)

 10.8

 Form of Employment Agreement with Neil Campbell. (13)

 10.9

 Form of Employment Agreement with Bruce Harmon. (13)

 10.10

 Form of Employment Agreement with Ralph Schiess. (2)

 10.11

 Amendment to Employment Agreement, dated October 15, 2020, by and between Proteomedix and Ralph Schiess. (2)

 10.12

 Amendment to Employment Agreement by and between Proteomedix and Ralph Schiess. (2)

 10.13

 Form of Employment Agreement with Christian Br hlmann. (2)

 10.14

 Amendment to Employment Agreement, dated October 16, 2020, by and between Proteomedix and Christian Br hlmann. (2)

 10.15

 Amendment to Employment Agreement by and between Proteomedix and Christian Br hlmann. (2)

 10.16

 Release, dated January 10, 2024, by and between the Company and Dr. Neil Campbell. (20)

 10.17

 Form of Indemnification Agreement for Directors and Officers. (13)

 10.18

 Asset Purchase Agreement, dated April 19, 2023, between the Company and Veru Inc. (11)

 10.19

 Amendment to Asset Purchase Agreement, dated September 29, 2023, between the Company and Veru Inc. (26)

 10.20

 Form of Non-Competition and Non-Solicitation Agreement, dated April 19, 2023. (11)

 10.21

 Form of Lock-Up Agreement, dated December 15, 2023, by and among the Company and certain stockholders of Proteomedix. (19)

 10.22

 Form of Non-Competition and Non-Solicitation Agreement, dated December 15, 2023, by and among the Company and certain stockholders of Proteomedix. (19)

 10.23

 Form of Stockholder Support Agreement, dated December 15, 2023, by and among the Company, Proteomedix, and certain stockholders of Proteomedix. (19)

 10.24

 Form of Subscription Agreement, dated December 15, 2023, by and among the Company, Proteomedix, and the Investor. (19)

 10.25

 Separation Agreement, dated January 17, 2024, between the Company and Erin Henderson. (21)

 10.26

 Consulting Agreement, dated January 17, 2024, between the Company and The Aetos Group. (21)

 10.27

 Debenture, dated January 23, 2024 issued to the Investor. (22)

 10.28

 Consulting Agreement, dated January 4, 2024, by and between the Company and Thomas Meier. (23)

 10.29

 Forbearance Agreement, dated April 24, 2024, between the Company and Veru (4)

 10.30

 Amendment to Non-Convertible Debenture, dated April 24, 2024, between the Company and Altos. (4)

 10.31

 Master Research Services Agreement, dated October 1, 2022, by and between Proteomedix AG and Immunovia, AB (5)

 10.32

 Collaboration Agreement, dated July 19, 2021, by and between Proteomedix AG and New Horizon Health Limited (5)

 10.33

 Amendment No. 1, dated June 26, 2023, to Collaboration Agreement, dated July 19, 2021, by and between Proteomedix AG and New Horizon Health Limited (5)

 10.34

 Release Agreement, dated June 10, 2024, between the Company and Bruce Harmon. (6)

 10.35

 Consulting Agreement, dated June 10, 2024, between the Company and Karina Fedasz. (7)

 10.36

 Form of Inducement Letter (10)

 10.37

 Amended and Restated Forbearance Agreement between the Company and Veru, dated September 19, 2024 (12)

 10.38

 Form of Securities Purchase Agreement dated October 2, 2024 relating to the sale of the Series C Preferred Stock and Warrants (15)

 10.39

 Form of Registration Rights Agreement dated as of October 2, 2024 relating to the resale of the shares of Common Stock underlying the Series C Preferred Stock and Warrants (15)

 10.40

 Form of ELOC Purchase Agreement dated October 2, 2024 (15)

 10.41

 Form of ELOC Registration Rights Agreement dated October 2, 2024 (15)

 10.42

 Waiver and Amendment No. 1 to Forbearance Agreement, dated November 26, 2024, between the Company and Veru (18)

 Code of Ethics. (25)

 16.1

 Letter from EisnerAmper LLP, dated October 21, 2024. (17)

 Insider Trading Policy, adopted August 7, 2023*

 List of Subsidiaries.*

 23.1

 Consent of Malone Bailey*

 23.2

 Consent of EisnerAmper LLP.*

 31.1

 Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*

 32.1

 Certification of the Principal Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**

 Policy Related to Recovery of Erroneously Awarded Compensation, adopted January 17, 2024.*

 101.INS*

 101.SCH*

 101.CAL*

 101.DEF*

 101.LAB*

 101.PRE*

 104*

 *
 Filed herewith.

 **
 Furnished herewith.

 Certain of the exhibits and
schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Company agrees to furnish a copy
of all omitted exhibits and schedules to the SEC upon its request.

 #
 Certain portions of this exhibit
(indicated by "[***]" have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K as we have determined they (1)
are not material and (2) are the type that the Company treats as private or confidential. The Registrant hereby agrees to furnish a copy
of any omitted portion to the SEC upon request.

 (1)
the Company's Registration Statement on Form S-1, filed with the SEC on October 8, 2021.

 (2)
the Company's Annual Report on Form 10-K, filed with the SEC on April 11, 2024.

 (3)
the Company's Current Report on Form 8-K, filed with the SEC on February 24, 2022.

 (4)
the Company's Current Report on Form 8-K, filed with the SEC on April 26, 2024.

 (5)
the Company's Registration Statement on Form S-1/A filed with the SEC on June 5, 2024.

 (6)
the Company's Current Report on Form 8-K, filed with the SEC on June 13, 2024.

 (7)
the Company's Amendment to Current Report on Form 8-K, filed with the SEC on June 14, 2024.

 (8)
the Company's Registration Statement on Form S-1/A, filed with the SEC on January 6, 2022.

 (9)
the Company's Current Report on Form 8-K filed with the SEC on April 24, 2023.

 (10)
the Company's Current Report on Form 8-K filed with the SEC on July 11, 2024.

 (11)
the Company's Current Report on Form 8-K filed with the SEC on April 20, 2023.

 (12)
the Company's Current Report on Form 8-K filed with the SEC on September 20, 2024.

 (13)
the Company's Current Report on Form 8-K filed with the SEC on October 10, 2023.

 (14)
the Company's Current Report on Form 8-K, filed with the SEC on September 24, 2024.

 (15)
the Company's Current Report on Form 8-K, filed with the SEC on October 3, 2024.

 (16)
the Company's Current Report on Form 8-K, filed with the SEC on September 20, 2024.

 (17)
the Company's Current Report on Form 8-K, filed with the SEC on October 21, 2024.

 (18)
the Company's Current Report on Form 8-K, filed with the SEC on December 3, 2024.

 (19)
the Company's Current Report on Form 8-K filed with the SEC on December 21, 2023.

 (20)
the Company's Current Report on Form 8-K filed with the SEC on January 12, 2024.

 (21)
the Company's Current Report on Form 8-K filed with the SEC on January 19, 2024.

 (22)
the Company's Current Report on Form 8-K filed with the SEC on January 29, 2024.

 (23)
the Company's Current Report on Form 8-K filed with the SEC on February 12, 2024.

 (24)
the Company's Registration Statement on Form S-1/A filed with the SEC on January 6, 2022.

 (25)
the Company's Registration Statement on Form S-1/A, filed with the SEC on November 5, 2021.

 (26)
the Company's Current Report on Form 8-K filed with the SEC on October 3, 2023.

 Item 16. Form 10-K Summary.

 We have elected not to include a summary pursuant to this Item 16.

 SIGNATURES

 Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.

 Onconetix, Inc.

 Date: May 30, 2025

 By:

 /s/ Karina Fedasz

 Interim Chief Executive Officer and

Interim Chief Financial Officer

 Pursuant to the requirements
of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in
the capacities indicated on May 30, 2025.

 Signature

 Title

 /s/ Karina Fedasz

 Interim Chief Executive Officer and Interim Chief Financial Officer

 /s/ Andrew Oakley

 Non-Executive Chairman of the Board

 Andrew Oakley

 /s/ Thomas Meier

 Thomas Meier

 /s/ Timothy Ramdeen

 Timothy Ramdeen

 /s/ Ajit Singh

 Ajit Singh

 /s/ Simon Tarsh

 Simon Tarsh

 Our common stock is traded on The Nasdaq Capital
Market under the trading symbol "ONCO."

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