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 UNITED
STATES

 SECURITIES
AND EXCHANGE COMMISSION

 Washington,
D.C. 20549

 Form

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

 For
the fiscal year ended December 31, 2023

 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 001-13467

 Inhibitor
Therapeutics, Inc.

 (Exact
name of registrant as specified in its charter)

 Delaware

 30-0793665

 (State
 or other jurisdiction of

 incorporation or organization)

 (I.R.S.
 Employer

 Identification No.)

 4905
 South West Shore Blvd
 Tampa, FL

 33611-3329

 (Address of principal
 executive offices)

 (Zip Code)

 Issuer's
telephone number: 813 - 864-2562

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

 Title
 of each class

 Name
 of exchange on which registered

 None

 n/a

 Securities
registered pursuant to Section 12(g) of the Act: Common stock, par value $.0001

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

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

by check mark whether the registrant (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

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

by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained,
to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. Yes No

by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, a smaller reporting
company or an emerging growth company. See definition 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.

by check mark whether the registrant 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. 7262(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.

by check mark whether any of those error corrections are restatements that require 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).

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

 The
aggregate market value of the voting and non-voting common equity held by non-affiliates as of June 30, 2023 was approximately $ 3.2 million
based on the closing sale price of the company's common stock on such date of $0.04 per share, as reported by the OTC Markets Group,
Inc.

 As
of March 29, 2024, there were 172,023,545 shares of company common stock issued and outstanding.

 Inhibitor
Therapeutics, Inc.

 Annual
Report on Form 10-K

 For
the fiscal year ended December 31, 2023

 TABLE
OF CONTENTS

 Cautionary Note on Forward-Looking Statements

 Summary of Material Risks Associated With Our Business

 Item
 1.

 Description of Business

 Item
 1A.

 Risk Factors

 Item
 1B.

 Unresolved Staff Comments

 Item
 1C.

 Cybersecurity

 Item
 2.

 Description of Property

 Item
 3.

 Legal Proceedings

 Item
 4.

 Mine Safety Disclosure

 Item
 5.

 Market for Common Equity and Related Stockholder Matters

 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

 Item
 9.

 Changes In and Disagreements with Accountants on Accounting and Financial Disclosure

 Item
 9A.

 Controls and Procedures

 Item
 9B.

 Other Information

 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, Financial Statement Schedules

 Item
 16.

 Form 10-K Summary

 Unless
we have indicated otherwise, or the context otherwise requires, references in this Report to "INTI," the "Company,"
"we," "us" and "our" or similar terms refer to Inhibitor Therapeutics, Inc., a Delaware corporation.

 CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS

 This
Report and the documents we have filed with the Securities and Exchange Commission (the "SEC") that are incorporated by reference
herein contain forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), that involve significant risks and uncertainties.
Any statements contained, or incorporated by reference, in this Report that are not statements of historical fact may be forward-looking
statements. When we use the words "anticipate," "believe," "could," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "will" and other
similar terms and phrases, including references to assumptions, we are identifying forward-looking statements. Forward-looking statements
involve risks and uncertainties which may cause our actual results, performance or achievements to be materially different from those
expressed or implied by those forward-looking statements.

 A
variety of factors, some of which are outside our control, may cause our operating results to fluctuate significantly. They include:

 acceptance
 of our business model by investors and potential commercial collaborators;

 our future capital requirements
 and our ability to satisfy our capital needs;

 our ability to commence
 and complete required clinical trials of our product candidates and obtain approval from the U.S. Food and Drug Administration (FDA)
 or other regulatory agencies in different jurisdictions;

 our ability to secure and
 maintain key development and commercialization partners for our product candidates;

 our ability to obtain,
 maintain or protect the validity of our owned or licensed patents and other intellectual property;

 our ability to internally
 develop, acquire or license new inventions and intellectual property;

 our ability to retain key
 executive members; and

 interpretations of current
 laws and the passages of future laws, rules and regulations applicable to our business.

 The
foregoing does not represent an exhaustive list of risks that may impact upon the forward-looking statements used herein or in the documents
incorporated by reference herein. Please see "Risk Factors" for additional risks which could adversely impact our business
and financial performance and related forward-looking statements.

new risks regularly emerge, and it is not possible for our management to predict all risks, nor can we assess the impact of all risks
on our business or the extent to which any risk, or combination of risks, may cause actual results to differ from those contained in
any forward-looking statements. All forward-looking statements included in this Report are based on information available to us on the
date hereof. Except to the extent required by applicable laws or rules, we undertake no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or otherwise. All subsequent written and oral forward-looking statements
attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained throughout
this Report and the documents we have filed with the SEC.

 SUMMARY
OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

 The
following is a summary of risks, uncertainties and other factors related to our company. 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.

 From 2018 through 2022
 we conducted only minimal operations due to litigation that was recently settled that was impeding our ability to finance and progress
 our business. Since closing the litigation on December 13, 2022, our efforts are centered on revising our business plan, including
 a website overhaul to reflect our 2023 direction to continue development of our intellectual property and acquire additional assets
 to enhance shareholder value.

 We are a pre-revenue pharmaceutical
 development company and are thus subject to the risks associated with early-stage businesses in that industry.

 Raising additional capital
 or issuing new securities in connection with strategic transactions may cause dilution to our stockholders, restrict our operations
 or require us to relinquish rights to our technologies or product candidates.

 We are early in our development
 efforts. Assuming we are able to raise new funding, if we are unable to clinically develop and ultimately commercialize Itraconazole
 or other product candidates, or experience significant delays in doing so, our business will be materially harmed.

 Clinical drug development
 involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing,
 or ultimately be unable to complete, the development and commercialization of our product candidate.

 Even if any of our product
 candidates receive marketing approval for any indication, they may fail to achieve the degree of market acceptance by physicians,
 patients, third-party payors and others in the medical community necessary for commercial success.

 We face substantial competition,
 which may result in others discovering, developing or commercializing products before or more successfully than we do.

 If we are unable to obtain
 and maintain patent protection for our technology and products (particularly itraconazole as an anti-cancer therapy), or if the scope
 of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products
 similar or identical to ours, and our ability to commercialize our technology and products may be impaired.

 Intellectual property litigation
 could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

 If we fail to obtain, or
 if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidate, and
 our ability to generate revenue and the viability of our company will be materially impaired.

 Special FDA regulatory
 designations, such as fast track, breakthrough therapy and orphan designation may not be available for our product candidates.

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

 Even if a market for our
 common stock develops, the market price of our common stock may be significantly volatile, which could result in substantial losses
 for purchasers.

 PART
I

 Item 1.
 Description
 of Business.

 Overview

 The
Company is a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics
based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with
certain cancers and certain non-cancerous proliferation disorders. We have explored and expect to continue to explore acquiring or licensing
other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other diseases based
on repurposing active ingredients of already approved drugs.

 Our
current primary focus is on the development of therapies initially for basal cell carcinoma ("BCC"), prostate and lung cancers
in the United States utilizing itraconazole, a drug currently approved by the FDA to treat fungal infections, and which has an extensive
history of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of
cancer patients using itraconazole. In particular, on December 12, 2023, the Company entered into an Exclusive License Agreement (the
"Agreement") with Johns Hopkins University ("JHU"). Pursuant to the Agreement, JHU granted to the Company the
exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled "New Angiogenesis Inhibitors" (the "Patent").
The Patent relates to the treatment of prostate cancer, BCC including basal cell carcinoma nevus syndrome ("BCCNS"), and
lung cancer.

to the Agreement: (i) the Company has received an exclusive worldwide license to the Patent; (ii) the Company paid JHU an upfront license
fee in December 2023, (iii) the Company shall be required to make certain Minimum Annual Royalty ("MAR") payments to JHU
no later than January 1st of each calendar year in accordance with an agreed upon schedule, (iv) the Company shall be required to pay
to JHU a royalty on cumulative net sales, with an additional supplement due where a licensed product is given exclusivity in the U.S.
by patent rights, (v) if the Company enters into any sublicense they will pay to JHU a certain percentage of all consideration received
from sublicensee but excluding (i) any consideration received by Licensee for Royalties on Sublicensee Sales (Royalties on Sales by Sublicensees
will be treated as if Licensee made the Sale), and (ii) any payment of Past Patent Costs or Patent Costs made by Sublicensee to License),
(vi) should the Company receive compensation in the form of a voucher, the Company will pay a certain percentage of the sale to JHU and
(vii) the Company shall be required to pay to JHU certain development-related milestone payments upon the Company meeting each of a series
of agreed upon milestones. The Agreement contains other customary terms and conditions.

 JHU
has the right to terminate the Agreement upon the occurrence of certain events, including delinquency in payments, failure to timely
reach milestones, noncompliance with audit or insurance obligations, or the Company entering into voluntary bankruptcy or insolvency.
The Company may terminate the Agreement without cause upon 90 days advance written notice.

 A
minority shareholder of the Company was involved in extended litigation for approximately five years with the former majority shareholder
of the Company, which through mediation finalized in late 2022 resulting in the forfeiture of all equity securities of the Company for
cancellation by the former majority shareholder and resignation of all Directors and Officers. As part of the settlement, the Company
received a cash payment of $14.25 million, forgiveness of certain debts owed by the Company to the former majority shareholder, new officers
and directors were elected, and the Company continued under new management.

 Following
the resolution of the litigation involving the Company in December 2022 and the resulting settlement agreement, the new Board and management
of the Company intend to continue the development of itraconazole for BCCNS, and other cancers and non-cancerous proliferative disorders.
To that end, the development or acquisition of its own proprietary and patent-protected formulation of itraconazole is anticipated, such
as the Agreement with JHU in December 2023, as well as exploring the addition of other product candidates that meet our strict criteria:
products that target an unmet medical need of significant clinical value, and are patent protected, and that qualify for the 505(b)2
regulatory pathway.

 Intellectual
Property

 We
strive to protect the intellectual property that we believe will be important to our business, including seeking our own patent protection
(or seeking licenses to patents) intended to cover the composition of matter of our product candidates, their methods of use, related
technology and other inventions that are important to our business.

 We
have developed, licensed, optioned to license, and are seeking to acquire and/or license, intellectual property and know-how related
to the treatment of cancer patients using itraconazole-based compounds.

 The
following is a summary of intellectual property in the form of issued U.S. patents we own, or for which we have exclusive licenses, regarding
the use of itraconazole as an anti-cancer therapy.

 Name

 Application
 Date

 Issuance
 Date

 Expiration
 Date

 Treatment and Prognostic
 Monitoring of Proliferation Disorders Using Hedgehog Pathway Inhibitors

 9,129,609

 February 5, 2014

 November 24, 2015

 Treatment and Prognostic
 Monitoring of Cancerous Proliferation Disorders Using Hedgehog Pathway Inhibitors

 9,962,381

 January 31, 2017

 May 8, 2018

 Treatment and Prognostic
 Monitoring of Non-Cancerous Proliferation Disorders Using Hedgehog Pathway Inhibitors

 9,968,600

 January 31, 2017

 May 15, 2018

 Treatment of Lung Cancer
 Using Hedgehog Pathway Inhibitors

 10,328,072

 April 30, 2018

 June 25, 2019

 Treatment of Prostate Cancer
 Using Hedgehog Pathway Inhibitors

 10,363,252

 April 30, 2018

 July 30, 2019

 Administering Itraconazole
 to Inhibit Angiogenesis in Undesired Tissue

 8,980,930

 June 27, 2005

 March 17, 2015

 February 4, 2029

 We
also plan to continue to expand our intellectual property estate and are filing additional patent applications directed to dosage forms,
methods of treatment, therapies for other cancers and additional Hedgehog inhibitor compounds and their derivatives.
W e will also rely on trade secrets and careful monitoring of our proprietary information to protect
aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

 The
Company and Mayne Pharma Ventures Pty Ltd. ("Mayne Pharma") entered into a license agreement (the "License Agreement")
pursuant to which the Company grants Mayne Pharma a worldwide, royalty-free, nonexclusive, perpetual, irrevocable license to certain
of the Company's Patents (as defined in the License Agreement) to the extent they relate to or have potential application in connection
with the Product (as defined in the License Agreement). Notwithstanding the foregoing, the Company has retained a royalty on future net
sales of SUBA-Itraconazole BCCNS in the United States, subject to credit for previously paid advances of $3.0 million by Mayne Pharma, after which any further royalty payments
due to the Company will be paid in full.

 The
Hedgehog Pathway

 Based
on the results of physician-sponsored studies conducted by others (including in vitro, animal, and human studies), we believe
that itraconazole affects the Hedgehog signaling pathway in cells and that it is a potent antiangiogenic, which in turn impacts the development
and growth of certain cancers. The studies, conducted at prominent medical institutions, primarily in the United States, were published
in the Journal of Thoracic Oncology, The Oncologist and the Journal of Clinical Oncology between May 2013 and February 2014. Based
on these studies, it appears that itraconazole has notable anti-cancer effects by one or more independent or synergistic mechanisms,
some of which are not clearly understood and will continue to be the subject of ongoing research. These studies, and our own work in
the clinic, formed the basis of our continued interest in the clinical development of itraconazole for treatment of human cancers.

 The
Hedgehog signaling pathway is a major regulator of many fundamental cellular processes in vertebrates, including primarily at the embryonic
stage of development but also as it relates to stem cell maintenance, cell differentiation, tissue polarity and cell proliferation. Based
on published research and our experience in human testing, we believe that inhibiting the Hedgehog pathway can delay or possibly prevent
the development of certain cancers in patients. Research has shown that activation of the Hedgehog pathway can lead to the formation
of cancerous tumors (a process known as tumorigenesis) such as the most common form of skin cancer known as BCC. It is apparent, however,
that other mutations seem to be required in order for the development of a basal cell carcinoma even in BCCNS. The antiangiogenic effects
of itraconazole, therefore, play a key role in its ability to treat cancers. A variety of other human cancers, including brain, gastrointestinal,
lung, breast and prostate cancers, also demonstrate inappropriate activation of this pathway. Hedgehog signaling from the tumor to the
surrounding cell structures has been shown to sometimes promote further tumorigenesis as well. This pathway has also been shown to regulate
proliferation of cancer stem cells and to increase tumor invasiveness.

 We
believe that the targeted inhibition of Hedgehog signaling is or may be effective in the treatment and prevention of many types of human
cancers. We also believe that the discovery and synthesis of specific Hedgehog pathway inhibitors may have significant clinical implications
regarding the development of novel cancer therapies. Several synthetic Hedgehog antagonists are now being studied, some of which are
undergoing clinical evaluation. The orally available compound, Erivedge, vismodegib, developed by Curis and sold to Genentech,
Inc. (a subsidiary of Roche), was the first Hedgehog inhibitor based therapy and Odomzo, sonidegib (developed by Novartis
and sold to Sun Pharma in 2015 by Novartis) is the second orally available compound, that has been approved for treatment of advanced
stages of BCC by the FDA. Most recently, in 2018, Daurismo, glasdegib oral capsules developed by Pfizer, was approved
by FDA for use in combination with low dose cytarabine for patients with newly diagnosed acute myeloid leukemia (AML), aged 75 or older
who are too frail to be treated with intensive chemotherapy.

 Repurposing
Itraconazole for Treating Cancer

 We
are implementing clinical and regulatory plans to enable the repurposing of itraconazole. This strategy is intended to significantly
reduce the risk and time to potential FDA approvals for marketing in the United States.

 Itraconazole
appears to have notable anti-cancer effects by one or more independent or synergistic mechanisms, some of which are not clearly understood
and continue to be the subject of ongoing research. These anti-cancer effects have been demonstrated in various animal models and, subsequently
in human studies over the last several years.

 In
animal models, itraconazole has also demonstrated an anti-angiogenic effect (i.e., inhibiting the formation of new blood vessels), which
may be important in controlling the proliferation of cancerous cells and tumors in humans based upon its interaction with certain cell-based
growth factors. Itraconazole also appears to induce changes related to the mTOR pathway, an important regulator of cell growth, proliferation
and survival which, when unregulated, can also lead to cancer. These effects have been demonstrated in a physician-based study conducted
to test the effects of itraconazole on late-stage lung cancer.

 Prostate

 Itraconazole
has already been tested as a treatment for men with metastatic castrate resistant prostate cancer ("mCRPC") in a multi-institutional
Phase 2 trial completed in 2011 and led by Johns Hopkins University which was published in 2013. This study showed that, at a specified
dose, there was a significant correlation to slowing the progression of cancer and extending survival.

 Lung

 Physicians
treating patients with advanced non-squamous non-small cell lung cancer ("NSCLC"), most often caused by cigarette smoking
have a variety of options when considering therapies to extend survival, particularly based upon recent approvals of immunotherapies,
known as checkpoint inhibitors for PD-L1 (programmed death ligand 1) such as Keytruda, pembrolizumab marketed by Merck and approved
by FDA in 2017 and potentially useful in about 25% of patients. However, if patients are not candidates for immunotherapy based on genetic
marker testing (PD-L1 positive) or do not have mutations for EGFR (epidermal growth factor receptor, 15% of patients), ALK (anaplastic
lymphoma kinase, 3-5% of patients), ROS1 (c-ros oncogene 1, 1-2% of patients) or BRAF (proto-oncogene B-Raf, 1-3% of patients) in order
to be treated with tyrosine kinase inhibitors, they will be given chemotherapy, in particular platinum based doublet therapy with pemetrexed
(Alimta).With a median survival of only 8-10 months while on these approved chemotherapy regimens, we believe that new therapies
for these patients are needed. We believe that the pre-clinical data and reported human data between 2011 and 2018 on the use of itraconazole
in conjunction with chemotherapy reflects positively on the use of itraconazole as an anti-cancer therapy for this form of lung cancer
in patients who do not present with markers that enable their treatment with the agents mentioned above. If these data prove to be applicable
to human treatment by improving survival, while dosing Itraconazole in combination with chemotherapy therapy (the combination of platinum-based
chemotherapy drugs in conjunction with pemetrexed), the treatment may qualify for one or more FDA accelerated programs, such as a breakthrough
therapy or fast track status.

 Basal
Cell Carcinoma

 Utilizing
SUBA-Itraconazole (a branded formulation of itraconazole) to treat BCC in patients with Gorlin Syndrome was the first indication that
we studied in a Phase 2b trial which was launched in August of 2015. We began recruiting and dosing subjects during the fourth quarter
of 2015, and we completed enrollment in the fourth quarter of 2017. Individuals who were enrolled in this trial must have been diagnosed
with Gorlin Syndrome and had numerous BCC tumors as well as met well-defined inclusion criteria in order to qualify for enrollment and
treatment with SUBA-Itraconazole (the patented formulation of itraconazole owned by Mayne).

 Gorlin
Syndrome is caused by a mutation in a gene called PTCH1. This mutation causes PTCH to lose its ability to inhibit SMO (a protein receptor
of the Hedgehog pathway) which controls Hedgehog Pathway signaling. With SMO not being inhibited, BCCNS patients develop multiple BCC
tumors over weeks, months and years on a continued basis. SUBA-Itraconazole is therefore being tested to study its ability to bind to
SMO (itraconazole has demonstrated SMO binding in animal and human studies), thus inhibiting Hedgehog pathway activity which leads to
the formation of the BCC tumors in these patients. The key objective of our Phase 2b trial was to demonstrate patient benefit by reducing
tumor burden that requires on-going intervention for tumor growth via surgery and/or use of more toxic Hedgehog inhibitor therapies.
After the Company completed the phase 2b study on 447 distinct basal cell carcinomas demonstrating an ORR in over 50% of these basal
cell carcinomas, Mayne Pharma assumed control of the SUBA-Itraconazole BCCNS program in December 2018 in exchange for (among other consideration)
a 9% quarterly cash royalty on future net sales, if any, of SUBA-Itraconazole BCCNS in the United States. To the best of the Company's
knowledge, Mayne Pharma has discontinued its development efforts of SUBA itraconazole for BCCNS and the Company is unaware of any plans
for its future development by Mayne. The aforementioned settlement agreement provides INTI with the right to pursue development or licensure
of an itraconazole formulation for any indication and the right to pursue a license to the JHU patents.

 Our
Potential Market

 The
following table depicts our current estimate of the total available market opportunity for our proposed anti-cancer therapies based upon
independent market research, scientific and industry publications, and management's knowledge of the U.S. oncology market. Our
estimates (including estimated product pricing) are based on assumptions and are subject to change.

 Inhibitor
Therapeutics, Inc. – Summary Estimated U.S. Market Opportunity

 Type

 Therapy
 Indication

 Potential
 for Itraconazole

 Target
 Patient Population

 U.S.
 Total Estimated Available Market (*)

 Prostate
 (1)

 Patients
 with metastatic castrate resistant prostate cancer (mCRPC) and rising PSA levels no longer responding to androgen deprivation therapy
 (ADT) or have discontinued use of newer anti-androgen therapies due to lack of efficacy or toxicity

 Delay
 the progression of metastatic disease

 23,000
 high-risk men with metastatic prostate cancer who are no longer responding to currently approved therapies due to biochemical resistance
 or toxicity

 $215M
 at year 5 ($843M cumulative from launch) based on Inhibitor Therapeutics estimates of $4,000 - $5,000 monthly cost of 2 nd
 line therapy

 Lung
 (2)

 Patients
 with advanced non-squamous cell, non-small cell lung cancer (NSCLC) who will be placed on Platinum Doublet/Pemetrexed IV Therapy

 Improve
 the current median 8 - 10 month survival achieved with best supportive care for patients who are not eligible for treatment with
 tyrosine kinase or checkpoint inhibitors

 45,000
 men and women with late-stage disease who may be treated with chemotherapy if not eligible for other therapies

 $270M
 at year 5 ($945M cumulative from launch based on Inhibitor Therapeutics estimates of $4,000 - $5,000 monthly cost of 2 nd
 or 3 rd line therapy

 Skin
 (3)

 Patients
 with BCC (basal cell carcinoma) lesions

 First
 indication: BCC tumors in Gorlin Syndrome Patients requiring surgery.

 Potential
for follow-on Indication: Patients with BCC facial lesions pending MOHs or other surgical procedures.

 Less
 toxic therapy than vismodegib or sonidegib for Gorlin Patients to delay surgeries; low toxicity therapy to delay or minimize surgical
 intervention for head and neck BCC tumors

 10,000
 Gorlin patients needing chronic BCC therapy; 65,000 BCC patients pending surgical treatment for facial tumors that require excision
 and potential plastic surgery

 $300M
 for Gorlin patients for which Inhibitor Therapeutics receives a 9% royalty on net sales in the U.S.; and $600M for patients with
 BCC facial lesions requiring surgery based upon estimates of $4,000 - $5,000 monthly cost of therapy for target populations

 (*)
estimated pricing subject to adjustment at the time of launch taking into consideration comparable products and required gross-to-net
adjustments.

 References:

 (1)

 J.
 Urology, 2003; Oncology, 2004; American J. Hematologic Oncology, 2014; NIH NCI SEER 2014; Medscape, 2015; Future Oncology
 2015; Global Data2015; Pennside Partners 2017

 (2)

 STATS
 MGU, 2009; Global Industry Analysts, 2010; World Health Organization, 2015; Cost of Treating Lung Cancer, 2012; LUNGevity Foundation
 2017; NEJM 2015; Pennside Partners 2017

 (3)

 J
 Am Academy Dermatology, 2006; Skin Cancer Foundation, 2009; International Medicine News, 2011; Seeking Alpha, 2017; BCCNS Life Support
 Network 2017, Genetics Home Reference 2015; Pennside Partners 2016

 Our
Strategy

 Our
goal is to be a leader in the development and commercialization of itraconazole-based therapeutics for the treatment of cancer patients
and patients with non-cancerous proliferation disorders, assuming in all cases that we obtain sufficient funding to recommence and thereafter
continue our operations. We believe that we can accomplish this goal by implementing the following key elements of our business strategy:

 Seek
 FDA Programs to Expedite Drug Approvals. The FDA has various programs intended to facilitate
 and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions.
 These expedited programs help ensure that therapies for serious conditions are available as soon as it can be concluded that the
 therapies' benefits justify their risks, taking into account the seriousness of the condition and the availability of alternative
 treatments. These programs include breakthrough therapy designation, fast track designation, accelerated approval, and priority review.
 We believe that Itraconazole for the treatment of cancer may qualify for one or more of these designations, which could help expedite
 the regulatory review process.

 Commercialize
 and Market with Exclusivity. We are developing specific clinical trial designs to address different forms of cancer and non-cancerous
 proliferation disorders in order to pursue FDA approvals for multiple indications. Further, we believe Itraconazole can be commercialized
 in a way that maximizes benefits for patients, based on our specific therapy regimens, while eliminating generic substitution and
 providing us with market exclusivity protections through our intellectual property rights.

 Formation
 of Scientific Advisory Board. In 2023, we were successful in creating a premier Scientific Advisory Board consisting of five
 experienced Mohs surgeons to critically review the outcomes of our Phase 2b clinical trial in BCCNS, and to provide continuing guidance
 to us as we navigate the FDA approval process and corporate strategy.

 Pursuing
 Strategic Partnerships. We have partnered with Avior Bio, Inc. for the creation of a new, patentable formulation of Itraconazole.
 Avior will assist us with FDA proceedings to ensure the best possible opportunity for approval.

 Exploring
 potential acquisitions. We continue to review the market for potential acquisitions. We have explored and will continue to explore
 acquiring or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs and orphan indications
 for the treatment of cancer and other diseases.

 We
have and expect to continue to finance our research and development, commercialization and distribution efforts and our working capital
needs primarily through:

 proceeds
 from public and private financings and, potentially, from other strategic transactions, including potential royalty-related financing
 transactions. Our attempts through 2022 to secure such financing were not successful, due to, among other factors, our prior litigation
 (finalized in December 2022) and the lack of market liquidity for our common stock;

 potential
 partnerships with other pharmaceutical companies to assist in the supply, manufacturing and distribution of our products for which
 we would expect to receive milestone and royalty payments;

 potential
 licensing and joint venture arrangements with third parties, including other pharmaceutical companies where we would receive funding
 based on out-licensing our product; and/or

 government
 or private foundation grants or loans which would be awarded to us to further develop our current and future anti-cancer therapies.

 Notwithstanding
the foregoing, our only source of financial liquidity as of the date of this Report is the cash on hand realized from the net proceeds
of the payment required pursuant to the settlement with the former majority shareholder of the Company.

 Background
on Cancer

is a heterogeneous group of diseases characterized by uncontrolled cell division and growth. Cancerous cells that arise in the lymphatic
system and bone marrow are referred to as hematological tumors. Cancer cells that arise in other tissues or organs are referred to as
solid tumors. Researchers believe that exposure to some chemicals, viruses and various forms of radiation can cause genetic alterations
that cause cancer. Genetic predispositions also can increase the risk of cancer in some people.

is the second leading cause of death in the United States, exceeded only by heart disease. The American Cancer Society reported that
an estimated total of approximately 1.9 million new cancer cases diagnosed and approximately 610,000 deaths occurred in the United States
in 2023.

 The
most common methods of treating patients with cancer are surgery, radiation and drug therapy. A cancer patient often receives treatment
with a combination of these methods. Surgery and radiation therapy are particularly effective in patients in whom the disease is localized
(not spread beyond the initial site of disease). Physicians generally use systemic drug therapies in situations in which the cancer has
spread beyond the primary site or cannot otherwise be treated through surgery. The goal of drug therapy is to damage and kill cancer
cells or to interfere with the molecular and cellular processes that control the development, growth and survival of cancer cells or
tumors. In many cases, drug therapy entails the administration of several different drugs in combination. Over the past several decades,
drug therapy has evolved from non-specific drugs that damage both healthy and cancerous cells, to drugs that target specific molecular
pathways involved in cancer and more recently to therapeutics that target the specific oncogenic "drivers" of cancer.

 Cytotoxic
Chemotherapies. The earliest approach to pharmacological cancer treatment was to develop drugs, referred to as cytotoxic drugs, which
kill rapidly proliferating cancer cells through non-specific mechanisms, such as disrupting cell metabolism or causing damage to cellular
components required for survival and rapid growth. While these kinds of drugs have been effective in the treatment of some cancers, many
unmet medical needs for the treatment of cancer remain. Also, cytotoxic drug therapies act in an indiscriminate manner, acting upon the
metabolism of healthy as well as cancerous cells. Due to their mechanism of action, many cytotoxic drugs have a narrow dose range above
which the toxicity causes unacceptable or even fatal levels of damage and below which the drugs are not effective in eradicating cancer
cells.

 Targeted
Therapies. The next approach to pharmacological cancer treatment was to develop drugs, referred to as targeted therapeutics, that
target specific biological molecules in the human body that play a role in rapid cell growth and the spread of cancer. Targeted therapeutics
include vascular disruptors, also referred to as angiogenesis inhibitors, which prevent the formation of new blood vessels and restrict
a tumor's blood supply. Other targeted therapies affect cellular signaling pathways that are critical for the growth of cancer.
While these drugs have been effective in the treatment of some cancers, most do not address the underlying cause of the disease. These
drugs focus on inhibiting processes that help the cancer cell survive, but not the oncogenes that are the drivers or cause of the cancer
itself.

 Oncogenic
Therapies. A more recent approach to pharmacological cancer treatment is to develop drugs that affect the drivers that cause uncontrolled
growth of cancer cells because of a specific genetic alteration. In some cases, these agents were identified as therapeutics without
knowledge of the underlying genetic change causing the disease. To date, the shortcoming of this research approach has been that it often
follows a conventional trial and error approach to drug discovery. In this approach, clinical development involves the treatment of large
populations from which a defined subpopulation that responds to treatment is identified. As a result, this approach can be time-consuming
and costly, with success often uncertain. Another major concern of these newly discovered drugs, some of which have been recently approved,
is that resistance to them occurs as the cancer finds new ways to circumvent the genetic pathway.

 Immunotherapies.
 Immunotherapy is the use of medicines to stimulate a person's own immune system to recognize and destroy cancer cells more
effectively. Immunotherapy can be used to treat many different types of cancer, including lung cancer, melanoma, renal, liver, cervical
and gastric cancers. An important part of the immune system is its ability to keep itself from attacking normal cells in the body. To
do this, it uses "checkpoints" – molecules on immune cells that need to be turned on (or off) to start an immune response.
Cancer cells sometimes use these checkpoints to avoid being attacked by the immune system. But newer drugs that target these checkpoints
are demonstrating a lot of promise as cancer treatments. These drugs target PD-1, a protein on immune system T cells that normally helps
keep these cells from attacking other cells in the body. By blocking PD-1, these drugs boost the immune response against cancer cells.
This can shrink many types of tumors or slow their growth. The new drugs can also target PD-L1, a protein related to PD-1 that is found
on some tumor cells and immune cells. Blocking this protein can also help boost the immune response against cancer cells. These drugs
can be used in people with certain types of cancer which starts growing again after chemotherapy or other drug treatments. They are also
used as a first treatment (instead of chemo) in some people and are given as an intravenous (IV) infusion every 2 or 3 weeks.

 The
Itraconazole Approach to Treating Cancer

 We
are focusing our developments on Hedgehog pathway inhibitor therapeutics for patients with certain cancers.

 Background
of Itraconazole. Itraconazole is FDA approved for and used to treat serious fungal or yeast
infections. This medicine works by killing the fungus or yeast and preventing its growth. Itraconazole is a prescription-based medication,
available as an IV solution, oral liquid, capsule or tablet.

and Hedgehog Inhibitors. The Hedgehog (also known as Hh) proteins comprise a group of secreted
proteins that regulate cell growth, differentiation and survival. They are involved in organogenesis (the formation of organs) and have
been shown to promote adult stem cell proliferation. Inappropriate activation of the Hh signaling pathway has been implicated in the
development of several types of cancers including prostate, lung, pancreas, breast, brain and skin. Hedgehog pathway inhibitors are a
relatively new class of therapeutic agents that act by targeting the proteins involved in the regulation of the Hh pathway. Many of these
newly discovered inhibitors are currently undergoing preclinical testing and some have entered clinical studies as anti-cancer agents
for a variety of cancers. Vismodegib was approved for treatment of locally advanced and metastatic basal cell carcinoma in early 2012,
 sonidegib was approved for locally advanced BCC in mid-2015 and glasdegib was approved in late 2018 for treatment of acute myeloid
leukemia.

 Similarly,
itraconazole has also been shown to suppress growth of brain tumors in animal models. It has also been shown to have anti-cancer effects
in basal cell carcinoma, lung cancer and prostate cancer in human clinical trials. Itraconazole acts as a SMO (a protein receptor of
the Hh pathway) antagonist (blocker), in a manner distinct from its anti-fungal activity which targets a compound found in fungi and
yeast known as ergosterol (a steroid found in the cell walls of fungi and yeast that functions in a fashion similar to cholesterol in
humans) as well as having anti-angiogenic properties.

 Sales
and Marketing

 We
are currently a pharmaceutical development company with no FDA approved products, and thus have not yet established a sales, marketing
or product distribution infrastructure because our product candidates are still in development. We may either license commercialization
rights to our product candidate to larger third-party partners, who will be responsible for sales, distribution and marketing efforts,
or we may (assuming adequate resources are available) retain commercial rights for our product candidates, in which case we would seek
to access the oncology market through a focused, specialized sales force of our own or in conjunction with a marketing partner under
a co-promotion agreement.

 Competition

 The
pharmaceutical industry is highly competitive and subject to rapid and substantial regulatory and technological changes, particularly
in the oncology field. Developments by others may render our itraconazole therapies, or any proposed product candidates and formulations
under development, non-competitive or obsolete, or we may be unable to keep pace with anti-cancer therapy developments or other market
factors. Anti-cancer therapy competition from pharmaceutical and biotechnology companies, universities, governmental entities and others
diversifying into the field is intense and is expected to increase.

 Government
Regulation and Product Approval

 Government
authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things,
the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing,
import and export of pharmaceutical products such as those we are developing. The processes for obtaining regulatory approvals in the
United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure
of substantial time and financial resources.

 United
States Government Regulation

 In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations.
The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes
and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States
requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety
of administrative or judicial sanctions, such as the FDA's refusal to approve pending NDAs, withdrawal of an approval, imposition
of a clinical hold, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production
or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

 The
process required by the FDA before a drug may be marketed in the United States generally involves the following:

 completion
 of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA's good laboratory practice,
 or GLP regulations;

 submission
 to the FDA of an IND application which must become effective before human clinical trials may begin;

 approval
 by an independent institutional review board (or IRB) at each clinical site before each trial may be initiated;

 performance
 of human clinical trials, including adequate and well-controlled clinical trials, in accordance with good clinical practices, or
 GCP, to establish the safety and efficacy of the proposed drug product for each indication;

 submission
 to the FDA of an NDA;

 satisfactory
 completion of an FDA advisory committee review, if applicable;

 satisfactory
 completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance
 with current good manufacturing practices (of cGMP) and to assure that the facilities, methods and controls are adequate to preserve
 the drug's identity, strength, quality and purity, as well as satisfactory completion of an FDA inspection of selected clinical
 sites to determine GCP compliance; and

 FDA
 review and approval of the NDA.

 Preclinical
Studies. Preclinical studies include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies
to assess potential safety and efficacy. An IND sponsor must submit the results of the preclinical tests, together with manufacturing
information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some preclinical
testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless
before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on
a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.
As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

 We
successfully avoided pre-clinical studies or any Phase 1 studies to demonstrate safety based on the fact that itraconazole has an established
history of safe and effective use in humans for anti-fungal indications and the fact that human data are already available and published
regarding use of itraconazole in humans for anti-cancer indications, such as basal cell carcinoma, lung cancer and prostate cancer.

 Clinical
Trials. Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified
investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent
in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things,
the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol
for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at
each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that
institution, and the IRB must continue to oversee the clinical trial while it is being conducted. Information about certain clinical
trials must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov
website.

 Human
clinical trials are typically conducted in three sequential phases, which may overlap or be combined. In Phase 1, the drug is initially
introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption,
metabolism, distribution, excretion and, if possible, to gain an initial indication of its effectiveness. In Phase 2, the drug typically
is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the
efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. In Phase 3, the drug is
administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical
trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall
risk-benefit profile of the product and to provide adequate information for the labeling of the product.

 Progress
reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse
events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all.
Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that
the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical
trial at its institution if the clinical trial is not being conducted in accordance with the IRB's requirements or if the drug
has been associated with unexpected serious harm to patients.

 Marketing
Approval. Assuming successful completion of the required clinical testing, the results of the preclinical and clinical studies, together
with detailed information relating to the product's chemistry, manufacture, controls and proposed labeling, among other things,
are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the
submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act ("PDUFA")
guidelines that are currently in effect, the FDA has agreed to certain performance goals regarding the timing of its review of an application.

 The
FDA also may require submission of a risk evaluation and mitigation strategy ("REMS") plan to mitigate any identified or
suspected serious risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and elements
to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools. We believe that a REMS
program, which includes intellectual property related to SUBA-Itraconazole and itraconazole, and the specific use of SUBA-Itraconazole
for anti-cancer indications, may likely provide additional protection of our proposed therapies from generic substitution.

 The
FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to determine
whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an
NDA for filing. In this event, the application must be resubmitted with additional information. The resubmitted application is also subject
to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review.
The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it
is manufactured, processed, packaged or held meets standards designed to assure the product's continued safety, quality and purity.

 The
FDA typically refers a question regarding a novel drug to an external advisory committee. An advisory committee is a panel of independent
experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application
should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers
such recommendations carefully when making decisions.

 Before
approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve
an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate
to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically
inspect one or more clinical trial sites to assure compliance with GCP.

 After
evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding
the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter.
A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of
the NDA and may require additional clinical or preclinical testing in order for FDA to reconsider the application. Even with submission
of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
If and when those conditions have been met to the FDA's satisfaction, the FDA will typically issue an approval letter. An approval
letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. Even if the FDA approves
a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included
in the product labeling, including a boxed warning, require that post-approval studies, including Phase 4 clinical trials, be conducted
to further assess a drug's safety after approval, require testing and surveillance programs to monitor the product after commercialization,
or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS (Risk Evaluation Mitigation
Strategy) which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing
of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved
product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements
and FDA review and approval.

 Special
FDA Expedited Review and Approval Programs. The FDA has various programs, including fast track designation, accelerated approval,
priority review and breakthrough designation, that are intended to expedite or simplify the process for the development and FDA review
of drugs that are intended for the treatment of serious or life-threatening diseases or conditions and demonstrate the potential to address
unmet medical needs. The purpose of these programs is to provide important new drugs to patients earlier than under standard FDA review
procedures. To be eligible for a fast-track designation, the FDA must determine, based on the request of a sponsor, that a product is
intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need.
The FDA will determine that a product will fill an unmet medical need if it will provide a therapy where none exists or provide a therapy
that may be potentially superior to existing therapy based on efficacy or safety factors.

 The
FDA may give a priority review designation to drugs that offer major advances in treatment or provide a treatment where no adequate therapy
exists. A priority review means that the goal for the FDA to review an application is six months, rather than the standard review of
ten months under current PDUFA guidelines. These six and ten-month review periods are measured from the "filing" date rather
than the receipt date for NDAs for new molecular entities, which typically adds approximately two months to the timeline for review and
decision from the date of submission. Most products that are eligible for fast-track designation are also likely to be considered appropriate
to receive a priority review.

 In
addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful
therapeutic benefit over existing treatments may receive accelerated approval and may be approved on the basis of adequate and well-controlled
clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical
benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to
predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence
of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require a sponsor of
a drug receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity
or mortality or other clinical endpoint, and the drug may be subject to accelerated withdrawal procedures.

under the provisions of the new Food and Drug Administration Safety and Innovation Act, or FDASIA, enacted in 2012, a sponsor can request
designation of a product candidate as a "breakthrough therapy." A breakthrough therapy is defined as a drug that is intended,
alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical
evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant
endpoints, such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies are
also eligible for accelerated approval. The FDA must take certain actions, such as holding timely meetings and providing advice, intended
to expedite the development and review of an application for approval of a breakthrough therapy.

 Even
if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for
qualification or decide that the time period for FDA review or approval will not be shortened. We believe that we may qualify for one
or more of these expedited approvals since our itraconazole anti-cancer therapies offer significant improvements in therapy for all of
our targeted anti-cancer indications should they be approved by FDA.

 Post-Approval
Requirements. Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the
FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising
and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding
new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing annual user fee requirements
for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental
applications with clinical data.

 The
FDA may impose a number of post-approval requirements as a condition of approval of an NDA. For example, the FDA may require post-NDA
analyses, such as overall survival (OS) or post-marketing testing, including Phase 4 clinical trials and surveillance to further assess
and monitor the product's safety and effectiveness after commercialization. In addition, drug manufacturers and other entities
involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies
and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements. Changes
to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also
require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor
and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money
and effort in the area of production and quality control to maintain cGMP compliance.

 Once
an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained
or if problems occur after the product reaches the market.

 Later
discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing
processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety
information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other
restrictions under a REMS program. Other potential consequences include, among other things:

 restrictions
 on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

 fines,
 warning letters or holds on post-approval clinical trials;

 refusal
 of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;

 product
 seizure or detention, or refusal to permit the import or export of products; or

 injunctions
 or the imposition of civil or criminal penalties.

 The
FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on the market. Although physicians,
in the practice of medicine, may prescribe approved drugs for unapproved indications, pharmaceutical companies generally are required
to promote their drug products only for the approved indications and in accordance with the provisions of the approved label. The FDA
and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found
to have improperly promoted off-label uses may be subject to significant liability.

 In
addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (or PDMA), which
regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation
of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples
and impose requirements to ensure accountability in distribution.

 Federal
and State Fraud and Abuse and Data Privacy and Security Laws and Regulations. In addition to FDA restrictions on marketing of pharmaceutical
products, federal and state fraud and abuse laws restrict business practices in the biopharmaceutical industry. These laws include anti-kickback
and false claims laws and regulations as well as data privacy and security laws and regulations.

 The
federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration
to induce or in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any item
or service reimbursable under Medicare, Medicaid, or other federal healthcare programs. The term "remuneration" has been
broadly interpreted to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical
manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. Although there are a number of statutory
exemptions and regulatory safe harbors protecting some common activities from prosecution, the exemptions and safe harbors are drawn
narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases, or recommendations
may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Several courts have interpreted the statute's
intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare
covered business, the statute has been violated.

 The
reach of the Anti-Kickback Statute was also broadened by the Patient Protection and Affordable Care Act of 2010, as amended by the Health
Care and Education Reconciliation Act of 2010 (which we refer to collectively as the PPACA), which, among other things, amended the intent
requirement of the federal Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of this statute
or specific intent to violate it in order to have committed a violation. In addition, PPACA provides that the government may assert that
a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the civil False Claims Act or the civil monetary penalties statute, which imposes penalties against any person
who is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know
is for an item or service that was not provided as claimed or is false or fraudulent. PPACA also created new federal requirements for
reporting, by applicable manufacturers of covered drugs, payments, and other transfers of value to physicians and teaching hospitals.

 The
federal False Claims Act prohibits any person from 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. A claim includes "any request or demand" for money or property presented to the U.S. government.
Several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing free product to customers
with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing
false claims to be submitted because of the companies' marketing of products for unapproved, and thus non-reimbursable, uses. The
federal Health Insurance Portability and Accountability Act of 1996 (or HIPAA) created new federal criminal statutes that prohibit 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. Also, many states have similar fraud and abuse statutes or
regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless
of the payor.

 In
addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct
our business. HIPAA, as amended by the Health Information Technology and Clinical Health Act (or HITECH) and its implementing regulations,
imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information. Among
other things, HITECH makes HIPAA's privacy and security standards directly applicable to "business associates," defined
as independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing
a service on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities,
business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions
in federal courts to enforce the federal HIPAA laws and seek attorney's fees and costs associated with pursuing federal civil actions.
In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each
other in significant ways and may not have the same effect, thus complicating compliance efforts.

 Coverage
and Reimbursement. The commercial success of our product candidate and our ability to commercialize any approved product candidate
will depend in part on the extent to which governmental authorities, private health insurers and other third-party payors provide coverage
for and establish adequate reimbursement levels for our therapeutic product candidates and related companion diagnostics. Government
health administration authorities, private health insurers and other organizations generally decide which drugs they will pay for and
establish reimbursement levels for healthcare. In particular, in the United States, private health insurers and other third-party payors
often provide reimbursement for products and services based on the level at which the government (through the Medicare or Medicaid programs)
provides reimbursement for such treatments. In the United States, government authorities and third-party payors are increasingly attempting
to limit or regulate the price of medical products and services, particularly for new and innovative products and therapies, which often
has resulted in average selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the
United States will put additional pressure on product pricing, reimbursement and usage, which may adversely affect our future product
sales and results of operations. These pressures can arise from rules and practices of managed care groups, judicial decisions and governmental
laws and regulations related to Medicare, Medicaid and healthcare reform, pharmaceutical reimbursement policies and pricing in general.

 Third-party
payors are increasingly imposing additional requirements and restrictions on coverage and limiting reimbursement levels for medical products.
For example, federal and state governments reimburse covered prescription drugs at varying rates generally below average wholesale price.
These restrictions and limitations influence the purchase of healthcare services and products. Legislative proposals to reform healthcare
or reduce costs under government insurance programs may result in lower reimbursement for our products and product candidates or exclusion
of our products and product candidates from coverage. The cost containment measures that healthcare payors and providers are instituting
and any healthcare reform could significantly reduce our revenues from the sale of any approved product candidates. We cannot provide
any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for our product candidate in
whole or in part.

 Impact
of Healthcare Reform on Coverage, Reimbursement, and Pricing. The Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (or MMA) imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries. Under Part
D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities that provide coverage of outpatient prescription
drugs. Part D plans include both standalone prescription drug benefit plans and prescription drug coverage as a supplement to Medicare
Advantage plans. Unlike Medicare Part A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required
to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover
and at what tier or level. However, Part D prescription drug formularies must include drugs within each therapeutic category and class
of covered Part D drugs, though not necessarily all the drugs in each category or class. Any formulary used by a Part D prescription
drug plan must be developed and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of prescription
drugs may increase demand for any products for which we receive marketing approval. However, any negotiated prices for our future products
covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies
only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting
their own payment rates. Any reduction in payment that results from Medicare Part D may result in a similar reduction in payments from
non-governmental payors.

 The
American Recovery and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different
treatments for the same illness. A plan for the research will be developed by the Department of Health and Human Services, the Agency
for Healthcare Research and Quality and the National Institutes for Health, and periodic reports on the status of the research and related
expenditures will be made to Congress. Although the results of the comparative effectiveness studies are not intended to mandate coverage
policies for public or private payors, it is not clear what effect, if any, the research will have on the sales of any product, if any
such product or the condition that it is intended to treat is the subject of a study. It is also possible that comparative effectiveness
research demonstrating benefits in a competitor's product could adversely affect the sales of our product candidates. If third-party
payors do not consider our product candidates to be cost-effective compared to other available therapies, they may not cover our product
candidates, once approved, as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell
our products on a profitable basis.

 The
United States is considering enacting or has enacted a number of additional legislative and regulatory proposals to change the healthcare
system in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the United States and
elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs,
improving quality and expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts
and has been significantly affected by major legislative initiatives, including, most recently, PPACA, which became law in March 2010
and substantially changes the way healthcare is financed by both governmental and private insurers. Among other cost containment measures,
the PPACA establishes an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and
biologic agents; a new Medicare Part D coverage gap discount program; and a new formula that increases the rebates a manufacturer must
pay under the Medicaid Drug Rebate Program. In the future, there may continue to be additional proposals relating to the reform of the
U.S. healthcare system, some of which could further limit the prices we are able to charge for our product candidates, once approved,
or the amounts of reimbursement available for our product candidates once they are approved.

 Exclusivity
and Approval of Competing Products

 Hatch-Waxman
Patent Exclusivity. In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with
claims that cover the applicant's product or a method of using the product. Upon approval of a drug, each of the patents listed
in the application for the drug is then published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations,
commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval
of an abbreviated new drug application (or ANDA), or a 505(b)(2) NDA.

 Generally,
an ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths, dosage form and route of
administration as the listed drug and has been shown to be bioequivalent through in vitro or in vivo testing or otherwise
to the listed drug. ANDA applicants are not required to conduct or submit results of preclinical or clinical tests to prove the safety
or effectiveness of their drug product, other than the requirement for bioequivalence testing. Drugs approved in this way are commonly
referred to as "generic equivalents" to the listed drug, and these drugs can often be substituted by pharmacists under prescriptions
written for the original listed drug. 505(b)(2) NDAs generally are submitted for changes to a previously approved drug product, such
as a new dosage form or indication. The 505(b)(2) regulatory pathway appears to be available for our proposed application of itraconazole
as an anti-cancer therapy based upon our communications with FDA to date.

 The
ANDA or 505(b)(2) NDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA's
Orange Book, except for patents covering methods of use for which the ANDA applicant is not seeking approval. Specifically, the applicant
must certify with respect to each patent that:

 the required
 patent information has not been filed;

 the listed patent has expired;

 the listed patent has not
 expired, but will expire on a particular date and approval is sought after patent expiration; or

 the listed patent is invalid,
 unenforceable, or will not be infringed by the new product.

 Generally,
the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired, except when the ANDA or 505(b)(2) NDA applicant challenges
a listed drug. A certification that the proposed product will not infringe the already approved product's listed patents or that
such patents are invalid or unenforceable is called a Paragraph IV certification. If the applicant does not challenge the listed patents
or indicate that it is not seeking approval of a patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until
all the listed patents claiming the referenced product have expired.

 If
the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the
Paragraph IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent
holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a
patent infringement lawsuit within 45 days after the receipt of notice of the Paragraph IV certification automatically prevents the FDA
from approving the ANDA or 505(b)(2) NDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit or a decision
in the infringement case that is favorable to the ANDA applicant.

 Hatch-Waxman
Non-Patent Exclusivity. Market and data exclusivity provisions under the FDCA also can delay the submission or the approval of certain
applications for competing products. The FDCA provides a five-year period of non-patent data exclusivity within the United States to
the first applicant to gain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously
approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the activity of the drug
substance. During the exclusivity period, the FDA may not accept an ANDA for review or a 505(b)(2) NDA submitted by another company that
contains the previously approved active moiety. However, an ANDA or 505(b)(2) NDA may be submitted after four years if it contains a
certification of patent invalidity or non-infringement.

 The
FDC also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA, or supplement to an existing NDA or 505(b)(2) NDA if
new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant, are deemed by the
FDA to be essential to the approval of the application or supplement. Three-year exclusivity may be awarded for changes to a previously
approved drug product, such as new indications, dosages, strengths or dosage forms of an existing drug. This three-year exclusivity covers
only the conditions of use associated with the new clinical investigations and, as a general matter, does not prohibit the FDA from approving
ANDAs or 505(b)(2) NDAs for generic versions of the original, unmodified drug product. Five-year and three-year exclusivity will not
delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a
right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety
and effectiveness.

 Orphan
Drug Exclusivity. The Orphan Drug Act provides incentives for the development of drugs intended to treat rare diseases or conditions,
which generally are diseases or conditions affecting less than 200,000 individuals annually in the United States. If a sponsor demonstrates
that a drug is intended to treat a rare disease or condition, the FDA grants orphan drug designation to the product for that use. The
benefits of orphan drug designation include research and development tax credits and exemption from user fees. A drug that is approved
for the orphan drug designated indication is granted seven years of orphan drug exclusivity. During that period, the FDA generally may
not approve any other application for the same product for the same indication, although there are exceptions, most notably when the
later product is shown to be clinically superior to the product with exclusivity. We obtained orphan drug designation for SUBA-Itraconazole
BCCNS in May 2016.

 Foreign
Regulation. Although it is not presently our intention to seek approval of our product candidates outside of the United States, in
the future we may do so, either directly or in conjunction with a marketing partner. 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 regarding safety and efficacy and
governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our products. We do however
intend to include sites outside the United States for our clinical trials in order to be able to recruit more patients for testing at
a greater number of locations and in less time than if we were to focus only on US-based sites. For example, in the European Union, we
would need to obtain authorization of a clinical trial application in each member state in which we intend to conduct a clinical trial.
Whether or not we obtain FDA approval for a product, 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 product 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.

 Human
Capital Resources

 As
of the date of this Report, we have three full-time employees and six part-time employees. The full-time employees include our Executive
Chairman who is involved in our clinical development program history and status, as well as vetting additional opportunities and operations.
The part-time employees include our Interim CFO, as well as administrative, legal and accounting functions. None of our employees are
covered by collective bargaining agreements. From time to time, we also employ independent contractors to support our clinical development
and administrative functions. We consider the number of our employees, their compensation, and their functions to be appropriate for
the current status of our business, and we also consider relations with each of our employees to be good. Each of our employees has entered
into confidentiality, intellectual property assignment and non-competition agreements with us.

 Corporate
History

 We
were founded under the name "Commonwealth Biotechnologies, Inc." in Virginia in 1992, and completed an initial public offering
in October 1997 (we refer to our company prior to our emergence from bankruptcy as CBI). CBI previously provided, on a contract basis,
specialized life sciences services to the pharmaceutical and biotechnology sector. On January 20, 2011, CBI filed a voluntary petition
for bankruptcy. We recommenced our business operations in August 2013 as a Delaware corporation following the emergence of CBI from its
voluntary bankruptcy.

 After
approximately five years of extended litigation between a minority shareholder and the former majority shareholder of the Company was
finalized through mediation in 2022, the former majority shareholder surrendered all equity securities of the Company for cancellation.
Certain defendants in the litigation were directors and officers of the Company at the time, and as a result of the legal settlement,
resigned from these positions. New officers and directors were then elected and the Company continued under new management.

 Available
Information

 Our
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to
Sections 13(a) and 15(d) of the Exchange Act are filed with the SEC. Such reports and other information that we file with the SEC are
available free of charge on our website at  when such reports are available on the SEC website. The SEC maintains
an Internet site that contains reports, proxy and information statements and other information regarding issuers like us that file electronically
with the SEC at  The contents of these websites are not incorporated into this filing. Further, the foregoing references
to the URLs for these websites are intended to be inactive textual references only.

 Item 1A.
 RISK
 FACTORS

 Investing
in our common stock is highly speculative and involves a high degree of risk. Before purchasing our common stock, you should carefully
consider the following risk factors as well as all other information contained in this Report, including our consolidated financial statements
and the related notes. The risks and uncertainties described below are not the only ones facing us. Additional risks and uncertainties
that we are unaware of, or that we currently deem immaterial, also may become important factors that affect us. If any of the following
risks occur, our business, financial condition or results of operations could be materially and adversely affected. In that case, the
trading price of our common stock could decline, and you may lose some or all of your investment.

 Risks
Relating to Our Business

 We
presently conduct only minimal operations. We are also subject to the risks associated with early-stage businesses in the pharmaceutical
industry.

 We
are a pharmaceutical development company with no history of revenue-generating operations. Therefore, we are, and expect for the foreseeable
future to be, subject to all the risks and uncertainties inherent in an early-stage pharmaceutical development company.

 Accordingly,
you should consider our prospects in light of the ongoing costs, uncertainties, delays and difficulties frequently encountered by companies
in their pre-revenue generating stages, particularly those in the pharmaceutical field. Potential investors should carefully consider
the risks and uncertainties that a company with no operating history will face. In particular, potential investors should consider that
there is a significant risk that we will not be able to:

 implement or
 execute our current business plan, or that our business plan is sound;

 maintain our management
 team or board of directors;

 raise sufficient funds
 in the capital markets or otherwise to effectuate our business plan;

 determine that the processes
 and technologies that we have developed are commercially viable; and/or

 attract, enter into or
 maintain contracts with potential commercial partners such as licensors of technology and suppliers.

 If
we cannot execute any one of the foregoing, our business may fail, in which case you may lose the entire amount of your investment in
our company.

 In
addition, we have in the past and expect that we may in the future encounter unforeseen expenses, difficulties, complications, delays
and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to
a company capable of supporting commercial activities. We may not be able to reach such point of transition or make such a transition,
which would have a material adverse effect on our company.

 Our
limited operating history makes it difficult for you to evaluate our business to date and to assess our future viability.

 Currently,
our primary line of business is the development and potential marketing of our itraconazole anti-cancer therapies, although presently
we are only conducting minimal operations due to the recent change in control and reconfiguration of our license/IP relationships as
described elsewhere herein. We acquired the assets related to this business opportunity on August 13, 2013 as part of our emergence from
bankruptcy. Our pre-bankruptcy historic business operations ceased contemporaneously with our becoming subject to bankruptcy proceedings
in 2011, and all assets supporting our earlier lines of business have been disposed of. Accordingly, we only recommenced active operations
on August 13, 2013, the date we emerged from bankruptcy.

 Our
operations presently consist of planning and conducting of pre-clinical testing and potential additional clinical trials, evaluating
opportunities for the raising of capital, developing our technology or seeking technology licenses or acquisitions, and identifying potential
commercial partners. We have not yet demonstrated our ability to obtain regulatory approvals, manufacture a commercial scale product,
or arrange for a third-party to do so on our behalf, or conduct sales and marketing activities necessary for product commercialization.
Consequently, any predictions you make about our future viability or ability to accomplish our business goals may not be as accurate
as they could be if we had a longer operating history.

 We
may be unable to acquire or license additional technologies to expand our product development pipeline.

 The
growth of our business will likely depend in part on our ability to acquire or in-license additional proprietary technologies related
to pharmaceutical therapies. The licensing and acquisition of third-party intellectual property rights is a competitive practice and
companies that may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party
intellectual property rights that we may consider attractive. More established companies may have a competitive advantage over us due
to their larger size and cash resources or greater clinical development and commercialization capabilities. There can be no assurance
that we will be able to successfully complete such negotiations and ultimately acquire or license the rights to additional product candidates
that we may seek to acquire.

 We
are dependent upon our officers and directors and their loss could adversely affect our ability to operate.

 Our
operations are dependent upon a very small group of individuals and, in particular, our current officers and directors, including most
notably Dr. Francis E. O'Donnell. We believe that our ability to implement our business plans depends on the continued service
of these individuals and/or other officers and directors. The unexpected loss of the services of one or more of our directors or officers
could have a detrimental effect on us.

 The
requirements of being a public company may strain our resources and divert management's attention.

 As
a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Act and other
applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance
costs, make some activities (including activities previously undertaken in a private company context) more difficult, time-consuming
or costly and increase demand on our systems and resources. The Sarbanes-Oxley Act requires, among other things, that we maintain effective
disclosure controls and procedures and internal control over financial reporting. In order to maintain and, if required, improve our
disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management
oversight may be required. As a result, management's attention may be diverted from other business concerns, which could adversely
affect our ability to implement our business plans. We may need to hire more employees in the future or engage outside consultants to
comply with these requirements, which will increase our costs and expenses.

 In
addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for
public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations
and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application
in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty
regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to
invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative
expenses and a diversion of management's time and attention from business development activities to compliance activities. If our
efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due
to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business
may be adversely affected.

 Our
business and operations would suffer in the event of system failures.

 Our
internal computer systems and those of our current and any future partners, contractors, and consultants are vulnerable to damage from
cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures.
This is particularly true in the case of collecting and analyzing clinical data, which is a key component of our business. System failures,
accidents, or security breaches could cause interruptions in our operations, and could result in a material disruption of our commercialization
activities, development programs and our business operations, in addition to possibly requiring substantial expenditures of resources
to remedy. The loss of clinical trial data from future clinical trials could result in delays in our regulatory approval efforts and
significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result
in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could
incur liability and the commercialization of any potential product candidate could be delayed.

 Risks
Related to Our Financial Position and Need For Additional Capital

 We
have no cash generating operations and may consume resources faster than expected.

 We
currently do not generate any revenue from product sales, royalties, or otherwise, and we therefore have a limited source of cash to
meet our future capital requirements. We do not expect to generate revenues or receive royalty revenue for the foreseeable future, and
we may not be able to raise funds in the future due to the nature of our company or other factors (some of which are beyond our control),
and our inability to raise funds would leave us without resources to continue operations and force us to resort to stockholder investments
or loans, which may not be available to us on reasonable terms or at all.

 Additionally,
we may have difficulty raising needed capital in the near or longer term as a result of, among other factors, the clinical stage nature
of our business, as well as the inherent business risks associated with our company and present and future market conditions. Also, we
may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated.
Our inability to raise funds could lead to decreases in the price of our common stock and the failure of our business.

 Raising
additional capital or issuing new securities in connection with strategic transactions may cause dilution to our stockholders, restrict
our operations or require us to relinquish rights to our technologies or product candidates.

 Since
we will be unable to generate any revenue from actual sales of products and expect to be in the development stage for the foreseeable
future, we will need to seek equity or debt financing to provide the capital required to execute our business plan. We will need significant
funding for developing, acquiring, or licensing our intellectual property, conducting clinical trials and entering into collaborations
with third-party partners as well as for working capital requirements and other operating and general corporate purposes.

 There
can be no assurance that we will be able to raise sufficient capital on acceptable terms, or at all. If such financing is not available
on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities
and our operations and financial condition may be adversely affected to a significant extent.

 If
we raise additional capital by issuing equity securities, the percentage and/or economic ownership of our existing stockholders may be
reduced, and accordingly these stockholders may experience substantial dilution. We may also issue equity securities that provide for
rights, preferences and privileges senior to those of our common stock.

 Debt
financing, if obtained, may involve agreements that include liens on our assets, covenants limiting or restricting our ability to take
specific actions, such as incurring additional debt, increases in our expenses and requirements that our assets be provided as a security
for such debt. Debt financing would also be required to be repaid regardless of our operating results.

 If
we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish some rights to our technologies
or product candidate, or to grant licenses on terms that are not favorable to us.

 Funding
from any source may be unavailable to us on acceptable terms, or at all. If we do not have sufficient capital to fund our operations
and expenses, our business could fail or become subject to bankruptcy.

we may issue equity securities in connection with potential strategic transactions such as acquisitions or licenses of other companies
or technologies. Such issuances could be in significant amounts and would also cause dilution to our stockholders and grant the recipients
of such securities varying amounts of control over our company and our business.

 Risks
Related to the Clinical Development of Our Product Candidate

 We
are early in our development efforts. Although we were able to settle our recent extended litigation and have adequate cash for near-term
planned operations, if we are unable to clinically develop and ultimately commercialize Itraconazole or other product candidates, or
experience significant delays in doing so, our business will be materially harmed.

 We
are early in our development efforts as of the date of this Report. Therefore, our ability to generate product or royalty revenues, which
we do not expect will occur for several years, if ever, will depend heavily on our ability to prevail in or settle our ongoing litigations,
and thereafter to raise new funding and develop and eventually commercialize our product candidate. The positive development of our product
candidate will depend on several factors, including the following:

 our ability
 to raise funds to progress our business, of which no assurances can be given;

 positive commencement and
 completion of clinical trials;

 successful preparation
 of regulatory filings and receipt of marketing approvals from applicable regulatory authorities;

 obtaining and maintaining
 patent and trade secret protection and potential regulatory exclusivity for our product candidate and protecting our rights in our
 intellectual property portfolio;

 launching commercial sales
 of our product, if and when approved for one or more indications, whether alone or in collaboration with others;

 acceptance of the product
 for one or more indications, if and when approved, by patients, the medical community and third-party payors;

 protection from generic
 substitution based upon our own or licensed intellectual property rights;

 effectively competing with
 other therapies;

 obtaining and maintaining
 adequate reimbursement from healthcare payors; and

 maintaining a continued
 acceptable safety profile of our product following approval, if any.

 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
clinically develop and commercialize therapies for cancer and non-cancerous proliferation disorders, which would materially harm our
business.

 Clinical
drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays
in completing, or ultimately be unable to complete, the development and commercialization of our product candidate.

 The
risk of failure for product candidates in clinical development is high. Clinical testing is expensive, difficult to design and implement,
can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing.
Moreover, the outcome of early clinical trials may not be predictive of the success of later clinical trials, and interim results of
a clinical trial do not necessarily predict final results. In addition, preclinical and clinical data are often susceptible to varying
interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials
have nonetheless failed to obtain marketing approval of their products.

 We
may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive
marketing approval or commercialize our product candidate, including:

 regulators
 or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial
 at a prospective trial site;

 we may experience delays
 in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial
 sites;

 clinical trials of our
 product candidate may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional
 clinical trials or abandon product development programs, which would be time consuming and costly;

 the number of patients
 required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may
 be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

 we may have to suspend
 or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed
 to unacceptable health risks;

 regulators or institutional
 review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance
 with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

 the cost of clinical trials
 may be greater than we anticipate;

 the supply or quality of
 materials necessary to conduct clinical trials of our product candidate may be insufficient or inadequate;

 our product candidate may
 have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators, or institutional
 review boards to suspend or terminate the trials; and

 interactions with other
 drugs.

 If
we are required to conduct additional clinical trials or other testing of our product candidate beyond those that we currently contemplate,
if we are unable to complete clinical trials of our product candidates or other testing, if the results of these trials or tests are
not positive or are only modestly positive or if there are safety concerns, we may:

 be delayed
 in obtaining marketing approval for our product candidate for one or more indications;

 not obtain marketing approval
 at all for one or more indications;

 obtain approval
 for indications or patient populations that are not as broad as intended or desired (particularly, in our case, for different types
 of cancer);

 obtain approval with labeling
 that includes significant use or distribution restrictions or safety warnings;

 be subject to additional
 post-marketing testing requirements; or

 have the product removed
 from the market after obtaining marketing approval.

 Our
product development costs will also increase if we experience delays in testing or marketing approvals. We do not know which, if any,
of our clinical trials will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical
trial delays also could shorten any periods during which we may have the right to commercialize our product candidate or allow our competitors
to bring products to market before we do and impair our ability to commercialize our product candidate and may harm our business and
results of operations.

 If
we experience delays or difficulties in the enrollment of patients in any future clinical trials, our receipt of necessary regulatory
approvals could be delayed or prevented.

 We
may not be able to initiate or continue future clinical trials for our present or future product candidates if we are unable to locate
and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities
outside the United States. In addition, some of our competitors have ongoing clinical trials for product candidates that treat the same
indications as our product candidate, and patients who would otherwise be eligible for our future clinical trials may instead enroll
in clinical trials of our competitors' product candidates.

 Patient
enrollment is affected by other factors including:

 the severity
 of the disease under investigation;

 the eligibility criteria
 for the study in question;

 the perceived risks and
 benefits of the product candidate under study;

 the patient referral practices
 of physicians;

 the ability to monitor
 patients adequately during and after treatment; and

 the proximity and availability
 of clinical trial sites for prospective patients.

 Our
inability to enroll a sufficient number of patients for any future clinical trials would result in significant delays and could require
us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs
for our product candidate, which would cause the value of our company to decline and otherwise materially and adversely affect our company.

 If
serious adverse or unacceptable side effects are identified during the development of our product candidate, we may need to abandon or
limit such development, which would adversely affect our company.

 If
clinical testing of our product candidates results in undesirable side effects or demonstrates characteristics that are unexpected, we
may need to abandon such development or limit such development to more narrow uses or subpopulations in which the undesirable side effects
or other characteristics are less prevalent, less severe, or more acceptable from a risk-benefit perspective. Many compounds that initially
showed promise in early-stage testing for treating cancer have later been found to cause side effects that prevented further development
of the compound.

 We
expect to rely on collaborations with third parties for key aspects of our business. If we are unable to secure or maintain any of these
collaborations, or if these collaborations do not achieve their goals, our business would be adversely affected.

 We
presently have very limited capabilities for drug development and do not yet have any capability for manufacturing, sales, marketing
or distribution. Accordingly, we expect to enter into collaborations with other companies that we believe can provide such capabilities.
These collaborations may also provide us with important funding for our development programs.

 There
is a risk that we may not be able to maintain our current collaboration or to enter into additional collaborations on acceptable terms
or at all, which would leave us unable to progress our business plan. We will face significant competition in seeking appropriate collaborators.
Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator's
resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator's evaluation of a
number of factors. If we are unable to maintain or reach agreements with suitable collaborators on a timely basis, on acceptable terms,
or at all, we may have to curtail the development of our product candidate, reduce or delay its development program, delay its potential
commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or
commercialization activities at our own expense.

even if we are able to maintain and/or enter into such collaborations, such collaborations may pose a number of risks, including the
following:

 collaborators
 may not perform their obligations as expected;

 disagreements with collaborators,
 including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays
 or termination of the research, development or commercialization of our product candidate, might lead to additional responsibilities
 for us with respect to such product candidate, or might result in litigation or arbitration, any of which would be time-consuming
 and expensive;

 collaborators could independently
 develop or be associated with products that compete directly or indirectly with our product candidate;

 collaborators could have
 significant discretion in determining the efforts and resources that they will apply to our arrangements with them;

 should our product candidate
 achieve regulatory approval, a collaborator with marketing and distribution rights to our product candidate may not commit sufficient
 resources to the marketing and distribution of such product;

 collaborators may not properly
 maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation
 that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; and

 collaborations may be terminated
 for the convenience of the collaborator and, if terminated, we could be required to either find alternative collaborators (which
 we may be unable to do) or raise additional capital to pursue further development or commercialization of our product candidate on
 our own.

 Our
business could be materially harmed if any of the foregoing or similar risks comes to pass with respect to our key collaborations.

 Risks
Related to the Commercialization of Our Product Candidates

 Even
if any of our product candidates receive marketing approval for any indication, they may fail to achieve the degree of market acceptance
by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

 Even
if product candidates we may acquire or license receive marketing approval for any indication, they may nonetheless fail to gain sufficient
market acceptance by physicians, patients, third-party payors and others in the medical community. For example, current cancer treatments
such as chemotherapy, immunotherapy and radiation therapy are well established in the medical community, and doctors may continue to
rely on these treatments. If our product candidate does not achieve an adequate level of acceptance, we may not generate significant
product revenues and we may not become profitable. The degree of market acceptance of product candidates for the treatment of cancer
and non-cancerous proliferation disorders, if approved for commercial sale, will depend on a number of factors, including:

 the efficacy
 and potential advantages compared to alternative treatments;

 our ability to offer our
 products for sale at competitive prices;

 the convenience and ease
 of administration compared to alternative treatments;

 the willingness of the
 target patient population to try new therapies and of physicians to prescribe these therapies;

 the strength of marketing
 and distribution support;

 the availability of third-party
 coverage and adequate reimbursement;

 the prevalence
 and severity of any side effects; and

 any restrictions on the
 use of our product together with other medications.

 If
we are unable to establish sales, marketing and distribution capabilities, we may not be able to commercialize our product candidate
if and when it is approved.

 We
currently do not have a sales or marketing infrastructure. To achieve any level of commercial success for any product for which we have
obtained marketing approval, we will need to establish a sales and marketing organization or outsource sales and marketing functions
to third parties.

 There
are risks involved with establishing our own sales, marketing and distribution capabilities. For example, recruiting and training a sales
force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we
recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or
unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or
reposition our sales and marketing personnel.

 If
approved, factors that may inhibit our efforts to commercialize our product on our own include:

 our inability
 to recruit, train and retain adequate numbers of effective sales and marketing personnel;

 the inability of sales
 personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe our product;

 the lack of complementary
 products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive
 product lines; and

 unforeseen costs and expenses
 associated with creating an independent sales and marketing organization.

 If
we are unable to or choose not to establish our own sales, marketing and distribution capabilities and instead enter into arrangements
with third parties to perform these services, our product revenues and our profitability, if any, are likely to be lower than if we were
to market, sell and distribute any products that we develop ourselves. In addition, we may be unable to enter into arrangements with
third parties to sell, market and distribute our product candidate or may be unable to do so on terms that are favorable to us. We likely
will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and
market our product effectively. If we do not establish sales, marketing and distribution capabilities, either on our own or in collaboration
with third parties, we will not be able to commercialize our product candidate, which would have a material adverse effect on our company.

 We
face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully
than we do.

 The
development and commercialization of new drug products is highly competitive. We face competition with respect to our current product
candidate and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future,
from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of
large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products
for the treatment of cancer. Potential competitors also include academic institutions, government agencies and other public and private
research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development,
manufacturing and commercialization.

 Our
commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,
have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors
also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result
in our competitors establishing a strong market position before we are able to enter the market.

 Many
of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources
and expertise in research and development, manufacturing, conducting clinical trials, obtaining regulatory approvals and marketing approved
products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being
concentrated among a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors,
particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting
and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical
trials, as well as in acquiring technologies complementary to, or necessary for, our programs, and we may be unable to effectively compete
with these companies for these or other reasons.

 Even
if we are able to commercialize any product candidates, the products 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 drug products vary widely from country to country.
Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause
delays in obtaining approvals.

 Our
ability to commercialize any product candidate also will depend in part on the extent to which coverage and adequate reimbursement for
our product candidate will be available from government health administration authorities, private health insurers and other organizations.
Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications
they will pay for and establish reimbursement levels. A primary 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 reimbursement for
particular medications. Increasingly, third-party payors are requiring that drug companies provide them with 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, even if these are available, the level of reimbursement may not be satisfactory. Reimbursement may
affect the demand for, or the price of, any product candidate for which we obtain marketing approval. Obtaining and maintaining adequate
reimbursement for our products may be difficult. We may be required to conduct expensive pharmacoeconomic studies to justify coverage
and reimbursement or the level of reimbursement relative to other therapies. If coverage and adequate reimbursement are not available
or reimbursement is available only to limited levels, we may not be able to commercialize any product candidate for which we obtain marketing
approval.

 In
addition, there may be significant delays in obtaining reimbursement for newly approved drugs, and coverage may be more limited than
the purposes for which the drug is approved by the FDA. Moreover, eligibility for reimbursement does not imply that a drug will be paid
for in all cases or at a rate that covers our costs, including research, development, 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. Reimbursement rates
may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already
set for lower cost drugs and 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. Third-party payors often rely upon Medicare coverage
policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and adequate reimbursement
rates from both government-funded and private payors for any approved products that we develop could have a material adverse effect on
our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

 Product
liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we
may develop.

 We
face an inherent risk of product liability exposure related to the testing of our product candidate in human clinical trials and will
face an even greater risk if we commercially sell any products that we may develop. If we cannot defend ourselves against claims that
our product candidate or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability
claims may result in:

 decreased demand
 for any product candidates or products that we may develop;

 damage to our reputation
 and significant negative media attention;

 withdrawal of clinical
 trial participants;

 significant costs to defend
 the related litigation;

 substantial monetary awards
 to trial participants or patients;

 loss of revenue;

 reduced resources of our
 management to pursue our business strategy; and

 the inability to commercialize
 any products that we may develop.

 We
currently do not have product liability insurance coverage, which leaves us exposed to any product-related liabilities that we may incur.
We may be unable to obtain insurance on reasonable terms or at all. Insurance coverage is increasingly expensive. 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.

 Risks
Related to Our Intellectual Property

 If
we are unable to obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained
is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and
our ability to commercialize our technology and products may be impaired.

 Our
business plan depends in large part on our ability to obtain and maintain patent protection in the United States with respect to our
proprietary technology and products. We will also need to obtain and maintain patent protection for any technologies we may acquire or
license in the future.

 The
patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent
applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our
research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have the
right to control (in whole or in part) the preparation, filing and prosecution of patent applications, or to maintain the patents, covering
technology that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner
consistent with the best interests of our business.

 The
patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions
and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to
the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment
of the human body more than United States law does. Publications of discoveries in the scientific literature often lag behind the actual
discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing,
or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our
owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions.
As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our pending
and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part,
or which effectively prevent others from commercializing competitive technologies and products. 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.

 Specifically,
United States Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances. From time to time,
the United States Supreme Court, other federal courts, the United States Congress, or interpretation by the United States Patent and
Trademark Office or USPTO, may change the standards of patentability and any such changes could have a negative impact on our business.
Some cases decided by the United States Supreme Court have involved questions of when claims reciting abstract ideas, laws of nature,
natural phenomena and/or natural products are eligible for a patent, regardless of whether the claimed subject matter is otherwise novel
and inventive. These cases include Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), also known
as the Myriad decision; Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), also known as the Alice decision; and Mayo
Collaborative Services v. Prometheus Laboratories, Inc., also known as the Prometheus decision, 566 U.S. 66 (2012). The full impact
of these decisions is not yet known. In view of these and subsequent court decisions, the USPTO has issued materials to patent examiners
providing guidance for determining the patent eligibility of claims reciting laws of nature, natural phenomena, or natural products.

 In
addition, patent reform legislation could further increase the uncertainties and costs surrounding the prosecution of our patent applications
and the enforcement or defense of our issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith
Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions
that affect the way patent applications are prosecuted and may also affect patent litigation. The United States Patent Office has developed
regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated
with the Leahy-Smith Act, and in particular, the first to file provisions, became effective on March 16, 2013. Accordingly, since we
have patent applications pending and plan to file for additional patents in the future, it is not clear what, if any, impact the Leahy-Smith
Act will have on the operation of our business. However, the Leahy-Smith Act 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, all of which could
have a material adverse effect on our business and financial condition.

we may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office, or become involved in
opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent
rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope
of, or invalidate our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without
payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition,
if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from
collaborating with us to license, develop or commercialize current or future product candidates.

 Even
if our owned and licensed patent applications are issued as patents, they may not issue in a form that will provide us with any meaningful
protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be
able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

 The
issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents
may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity
or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our
ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent
protection of our technology and products. Given the amount of time required for the development, testing and regulatory review of our
product candidate, patents protecting such candidate might expire before or shortly after such candidates are commercialized. As a result,
our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar
or identical to ours.

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

 Competitors
may infringe on our owned or licensed patents or other intellectual property. To counter infringement or unauthorized use, we may be
required to file infringement claims, which can be expensive and time consuming. Any claims we assert against perceived infringers could
provoke these parties to assert counterclaims against us alleging that we infringe their patents. In addition, in a patent infringement
proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent's claims
narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology
in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted
narrowly.

 We
have licensed or expect to license certain intellectual property from third parties, and such licenses may not continue to be available
or may not be available on commercially reasonable terms.

 We
have and/or expect to enter into licenses with third parties that hold intellectual property, including patent rights, that are important
or necessary to the development of itraconazole as an anti-cancer therapy, and it may be necessary for us to use the patented or proprietary
technology of third parties to commercialize itraconazole as an anti-cancer therapy, in which case we have or would be required to obtain
a license from these third parties on commercially reasonable terms, or else our business could be harmed, possibly materially. Even
though we have had patents issued for our own inventions in the United States in November 2015, May 2018, June 2019 and July 2019, if
we were not able to maintain our current license or obtain additional licenses or were not able to maintain or obtain such licenses on
commercially reasonable terms, our business could be harmed, possibly substantially.

 Third
parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would
be uncertain and could have a material adverse effect on our business.

 Our
business will depend upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our product candidates
and use our proprietary technologies without infringing the proprietary rights of third parties. There is considerable intellectual property
litigation in the biotechnology and pharmaceutical industries. We may become party to, or threatened with, future adversarial proceedings
or litigation regarding intellectual property rights with respect to our primary product candidate or other products and technology,
including interference or derivation proceedings before the U.S. Patent and Trademark Office. Third parties may assert infringement claims
against us based on existing patents or patents that may be granted in the future.

 If
we are found to infringe a third party's intellectual property rights, we could be required to obtain a license from such third
party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on
commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors
access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing
technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys' fees
if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates
or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the
confidential information or trade secrets of third parties could have a similar negative impact on our business.

 If
we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose rights that are important
to our business.

 We
are and expect to be party to one or more license or similar agreements that may impose due diligence, development and commercialization
timelines, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with our obligations under current
or future licenses, our counterparties may have the right to terminate these agreements, in which case we might not be able to develop,
manufacture or market any product that is covered by these agreements or may face other penalties under the agreements. Such an occurrence
could materially adversely affect the value of the product candidate being developed under any such agreement. Termination of these agreements
or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with
less favorable terms or cause us to lose our rights under these agreements, including our rights to important intellectual property or
technology.

 Intellectual
property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

 Even
if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant
expenses and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public
announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors
perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or
proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future
sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings
adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because
of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings
could compromise our ability to compete in the marketplace.

 Risks
Related to Regulatory Approval of Our Product Candidates and Other Legal and Compliance Matters

 If
we fail to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product
candidate, and our ability to generate revenue and the viability of our company will be materially impaired.

 Our
product candidates and the activities associated with their clinical development and commercialization, including matters relating to
design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution,
are subject to comprehensive regulation by the FDA (including under the Federal Food, Drug and Cosmetic Act) and other regulatory agencies
in the United States and by the European Medicines Agency (known as the EMA) and similar regulatory authorities outside the United States.
Failure to obtain marketing approval for our product candidates will prevent us from commercializing the product candidate.

 Securing
marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities
for each therapeutic indication to establish the product candidate's safety and efficacy. Securing marketing approval also requires
the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory
authorities. Our product candidate may not be effective, may be only moderately effective or may prove to have undesirable or unintended
side effects, toxicities or other characteristics that may preclude us from obtaining marketing approval or prevent or limit commercial
use of our product. In particular, new cancer drugs frequently are indicated only for patient populations that have not responded to
an existing therapy or have relapsed.

 The
process of obtaining marketing approvals in the United States is very expensive, may take many years, if approval is obtained at all,
and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidate involved.
Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations,
or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application.
Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that
our data are insufficient for approval and require additional preclinical, clinical or other studies.

 In
addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing
approval of our product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval
commitments that render the approved product not commercially viable.

 If
we experience delays in obtaining approval or if we fail to obtain approval of our product candidate, the commercial prospects for our
product candidate will be harmed and our ability to generate revenues, and the viability of our company generally, will be materially
impaired.

 We
may also be subject to healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse
effect on our results of operations and financial conditions.

 Although
we currently do not directly market or promote any products, we may also be subject to several healthcare regulations and enforcement
by the federal government and the states and foreign governments in which we conduct our business. The laws that may affect our ability
to operate include:

 the federal
 HIPAA and HITECH laws, which govern the conduct of certain electronic healthcare transactions and protects the security and privacy
 of protected health information;

 the federal healthcare
 programs' Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving,
 offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or
 the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such
 as the Medicare and Medicaid programs;

 federal false claims laws
 which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment
 from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

 federal criminal laws that
 prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
 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 payor, including commercial insurers.

 If
our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us,
we may be subject to penalties, including civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations,
the exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability
to operate our business and our financial results.

 Orphan
designation for our product candidates may be difficult to obtain, and if our competitors are able to obtain orphan drug exclusivity
for their products that are the same drug or a similar medicinal product as our product candidates, we may not be able to have competing
products approved by the applicable regulatory authority for a significant period of time.

 Regulatory
authorities may designate drugs for relatively small patient populations as "orphan" drugs. Generally, if a product with
an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the
product is entitled to a period of market exclusivity, which, subject to certain exceptions, precludes the FDA from approving another
marketing application for the same drug for the same indication for that time period. The applicable market exclusivity period is seven
years in the United States.

 Obtaining
orphan drug exclusivity for our product candidates may be important to our commercial strategy. If a competitor obtains orphan drug exclusivity
for and approval of a product with the same indication as our product candidates before we do, and if the competitor's product
is the same drug or a similar medicinal product as ours, we could be excluded from the market. Even if we obtain orphan drug exclusivity
after FDA approval, we may not be able to maintain it. For example, if a competitive product that is the same drug or a similar medicinal
product as our product candidate is shown to be clinically superior to our product candidate, any orphan drug exclusivity we have obtained
will not block the approval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product
that is the same drug as our product candidates if the FDA finds that we cannot assure the availability of sufficient quantities of the
drug to meet the needs of the persons with the disease or condition for which the drug was designated. If one or more of these events
occur, it could have a material adverse effect on our company.

 Even
if we obtain marketing approval for our product candidates, we could be subject to post-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.

 Even
if we obtain marketing approval for our product candidates, along with the manufacturing processes, post-approval clinical data, labeling,
advertising and promotional activities for such product, we will be subject to continual requirements of and review by the FDA and other
regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration
and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance
of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. In addition, even if marketing
approval of our product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product
may be marketed or to the conditions of approval, including the requirement to implement a risk evaluation and mitigation strategy. New
drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed. If our product
candidates receive marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales
of the products.

 The
FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy
of our products. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the
approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers'
communications regarding off-label use and if we or any third-party partners of ours do not market our products for their approved indications,
we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act relating to the
promotion of prescription drugs may lead to investigations alleging violations of federal and state health care fraud and abuse laws,
as well as state consumer protection laws.

 In
addition, later discovery of previously unknown adverse events or other problems with our product, manufacturers or manufacturing processes,
or failure to comply with regulatory requirements, may yield various results, including:

 restrictions
 on such product, our manufacturers or manufacturing processes;

 restrictions on the labeling
 or marketing of the product;

 restrictions of product
 distribution use;

 requirements to conduct
 post-marketing studies or clinical trials;

 the need to utilize warning
 letters;

 suspension or withdrawal
 of marketing approvals;

 withdrawal of the product
 from the market or product recalls;

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

 fines, restitution or disgorgement
 of profits or revenues;

 product seizure; or

 injunctions or the imposition
 of civil or criminal penalties.

 We
may face similar issues in connection with non-compliance with non-U.S. regulatory requirements.

 Risks
Related to Our Securities

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

 An
investment in our company will likely require a long-term commitment, with no certainty of return. Although our common stock is listed
for quotation on the OTCQB marketplace operated by OTC Markets Group, Inc., trading has been very limited, and we cannot predict whether
an active market for our common stock will ever develop in the future. In the absence of an active trading market:

 investors may
 have difficulty buying and selling or obtaining market quotations;

 market visibility for shares
 of our common stock may be limited; and

 a lack of visibility for
 shares of our common stock may have a depressive effect on the market price for shares of our common stock.

 The
OTCQB market is a relatively unorganized, inter-dealer, over-the-counter market that provides significantly less liquidity than NASDAQ
or the NYSE American (formerly known as the American Stock Exchange). This illiquid trading market for our common stock may make it difficult
for you to dispose of your common stock at desirable prices or at all.

 The
lack of an active market impairs 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 market value of your shares. An inactive market may also impair our ability to
raise capital to continue to fund operations by selling shares and may impair our ability to acquire additional intellectual property
assets by using our shares as consideration.

while we may seek to have our common stock listed on the NASDAQ Stock Market, there is a risk that we will be unable to do so, which
would leave our common stock listed on the OTCQB and subject to the foregoing risks of illiquidity.

 We
may not maintain qualification for OTCQB inclusion, and therefore you may be unable to sell your shares.

 Our
common stock is eligible for quotation on the OTCQB. However, trading of our common stock could be suspended, including due to our inability
to pay the required fees to the OTC Markets for listing our common stock on the OTCQB. If for any reason our common stock does not become
eligible or maintain eligibility for quotation on the OTCQB or a public trading market does not develop, purchasers of shares of our
common stock may have difficulty selling their shares should they desire to do so. If we are unable to satisfy the requirements for quotation
on the OTCQB, any quotation in our common stock could be conducted on the OTC Pink Market, which is an unorganized and often illiquid
market. As a result, a purchaser of our common stock may find it more difficult to dispose of, or to obtain accurate quotations as to
the price of their shares. This would materially and adversely affect the liquidity of our securities.

 Even
if a market for our common stock develops, the market price of our common stock may be significantly volatile, which could result in
substantial losses for purchasers.

 The
market price for our common stock may be significantly volatile and subject to wide fluctuations in response to factors including the
following:

 actual or anticipated
 fluctuations in our quarterly or annual operating results;

 changes in financial or
 operational estimates or projections;

 conditions in markets generally;

 changes in the economic
 performance or market valuations of companies similar to ours;

 general economic or political
 conditions in the United States or elsewhere; and

 litigation.

 In
particular, the market prices for securities of biotechnology companies have historically been particularly volatile. Some of the factors
that may cause the market price of our common stock to fluctuate include:

 any delay in
 or the results of our clinical trials;

 the announcements of clinical
 trial data, and the investment community's perception of and reaction to those data;

 the results of clinical
 trials conducted by others on products that would compete with our product candidate;

 any litigation in which
 the Company is a party, including the Action;

 any delay or failure to
 receive NDA acceptance and approval by FDA and other regulatory agencies or bodies;

 our inability to commercially
 launch our product or market and generate sales of our product;

 failure of our product,
 even if approved for marketing, to achieve any level of commercial success;

 our failure to obtain or
 maintain patent protection for any of our technologies and product or the issuance of third-party patents that cover our technologies
 or product;

 developments or disputes
 concerning our product's intellectual property rights;

 our competitors'
 technological innovations;

 general and industry-specific
 economic conditions that may affect our expenditures;

 changes in market valuations
 of similar companies;

 announcements by us or
 our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies,
 or patents;

 failure to
 adequately manufacture our product through third parties for purposes of clinical trials or actual sales;

 future sales of our common
 stock or other securities;

 period-to-period fluctuations
 in our financial results;

 low trading volume of our
 common stock; and

 failure to obtain or maintain
 license agreements.

 In
addition, if we fail to reach an important research, development or commercialization milestone or result by a publicly expected deadline,
even if by only a small margin, there could be significant impact on the market price of our common stock. Additionally, as we approach
the announcement of anticipated significant information and as we announce such information, we expect the price of our common stock
to be particularly volatile, and negative results would have a substantial negative impact on the price of our common stock.

 In
some cases, following periods of volatility in the market price of a company's securities, stockholders have often instituted class
action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion
of management attention and resources, which could significantly harm our business operations and reputation.

 Our
management and three significant stockholders collectively own a substantial majority of our common stock and voting power.

 Collectively,
our officers, our directors and three significant stockholders own or exercise voting and investment control of approximately 53% of
our common stock as of the date of this Report. As a result, investors may be prevented from affecting matters involving our company,
including:

 the composition
 of our Board of Directors and, through it, any determination with respect to our business direction and policies, including the appointment
 and removal of officers;

 any determinations with
 respect to mergers or other business combinations;

 our acquisition or disposition
 of assets; and

 our corporate financing
 activities.

 Furthermore,
this concentration of voting power could have the effect of delaying, deterring or preventing a change of control or other business combination
that might otherwise be beneficial to our stockholders. This significant concentration of share ownership may also adversely affect the
trading price for our common stock because investors may perceive disadvantages in owning stock in a company that is controlled by a
small number of stockholders.

 Future
sales of our common stock in the public market could lower the price of our common stock and impair our ability to raise funds in future
securities offerings.

 Significant
blocks of our stock and options to purchase our common stock are held by our management and significant shareholders. Future sales of
a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could adversely
affect the then prevailing market price of our common stock and could make it more difficult for us to raise funds in the future through
a public offering of our securities.

 Our
common stock is considered a "penny stock," and thereby is subject to additional sale and trading regulations that may make
it more difficult to sell.

 Our
common stock is considered a "penny stock" as it does not qualify for one of the exemptions from the definition of "penny
stock" under Section 3a51-1 of the Securities Exchange Act of 1934. Our common stock will be a "penny stock" for so
long as it meets one or more of the following conditions: (i) the stock trades at a price less than $5 per share; (ii) it is not traded
on a "recognized" national exchange; or (iii) is issued by a company (such as ours) that has been in business less than three
years with net tangible assets less than $5 million.

 The
principal result or effect of being designated a "penny stock" is that securities broker-dealers participating in sales of
our common stock will be subject to the "penny stock" regulations set forth in Rules 15g-2 through 15g-9 promulgated under
the Exchange Act. For example, Rule 15g-2 requires broker-dealers dealing in penny stocks to provide potential investors with a document
disclosing the risks of penny stocks and to obtain a manually signed and dated written receipt of the document at least two business
days before effecting any transaction in a penny stock for the investor's account. Moreover, Rule 15g-9 requires broker-dealers
in penny stocks to approve the account of any investor for transactions in such stocks before selling any penny stock to that investor.
This procedure requires the broker-dealer to: (i) obtain from the investor information concerning his or her financial situation, investment
experience and investment objectives; (ii) reasonably determine, based on that information, that transactions in penny stocks are suitable
for the investor and that the investor has sufficient knowledge and experience as to be reasonably capable of evaluating the risks of
penny stock transactions; (iii) provide the investor with a written statement setting forth the basis on which the broker-dealer made
the determination in (ii) above; and (iv) receive a signed and dated copy of such statement from the investor, confirming that it accurately
reflects the investor's financial situation, investment experience and investment objectives. Compliance with these requirements
may make it more difficult and time-consuming for holders of our common stock to resell their shares to third parties or to otherwise
dispose of them in the market or otherwise.

 FINRA
sales practice requirements may also limit your ability to buy and sell our common stock, which could depress the price of our shares.

 FINRA
rules require broker-dealers to have reasonable grounds for believing that an investment is suitable for a customer before recommending
that investment to the customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers
must make reasonable efforts to obtain information about the customer's financial status, tax status and investment objectives,
among other things. Under interpretations of these rules, FINRA believes that there is a high probability such speculative low-priced
securities will not be suitable for at least some customers. Thus, FINRA requirements make it more difficult for broker-dealers to recommend
that their customers buy our common stock, which may limit your ability to buy and sell our shares, have an adverse effect on the market
for our shares, and thereby depress our share price.

 You
may face significant restrictions on the resale of your shares due to state "blue sky" laws.

 Each
state has its own securities laws, often called "blue sky" laws, which (1) limit sales of securities to a state's residents
unless the securities are registered in that state or qualify for an exemption from registration, and (2) govern the reporting requirements
for broker-dealers doing business directly or indirectly in the state. Before a security is sold in a state, there must be a registration
in place to cover the transaction, or it must be exempt from registration. The applicable broker-dealer must also be registered in that
state.

 We
do not know whether our securities will be registered or exempt from registration under the laws of any state. A determination regarding
registration will be made by those broker-dealers, if any, who agree to serve as market makers for our common stock. We have not yet
applied to have our securities registered in any state and will not do so until we receive expressions of interest from investors resident
in specific states after they have viewed this Report. There may be significant state blue sky law restrictions on the ability of investors
to sell, and on purchasers to buy, our securities. You should therefore consider the resale market for our common stock to be limited,
as you may be unable to resell your shares without the significant expense of state registration or qualification.

 There
may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may
materially harm our company.

 Proper
systems of internal controls over financial accounting and disclosure are critical to the operation of a public company. Given the size
of our company and the limited number of full-time employees that we have employed, there may be certain limitations on the effectiveness
of our internal controls. Moreover, we do not expect that disclosure controls or internal control over financial reporting will prevent
all errors and all fraud, if any. A control system, no matter how well designed and operated, can provide only reasonable, not absolute,
assurance that the control system's objectives will be met. Further, the design of a control system must reflect the fact that
there are resource constraints and the benefits of controls must be considered relative to their costs. 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. Failure of our control systems to prevent error or fraud could materially and adversely impact us.

 Because
we became public by means other than a traditional initial public offering, we may not be able to attract the attention of major brokerage
firms.

 Our
business was created when certain operating assets were contributed to our company in August 2013 as our company was a "shell company"
emerging from bankruptcy. Since our current business became a public company by means other than a traditional initial public offering,
investors and securities analysts may be reluctant to invest in or provide research coverage of us. This stigma could impair our fundraising
opportunities and our reputation generally.

 If
securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding
our stock adversely, our stock price and trading volume could decline.

 The
trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about
us or our business. We do not currently have and may never obtain research coverage by industry or financial analysts. If no or few analysts
commence coverage of us, the trading price of our stock would likely decrease. Even if we do obtain analyst coverage, if one or more
of the analysts who cover us downgrade our stock, our stock price would likely decline. If one or more of these analysts cease coverage
of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock
price or trading volume to decline.

 Anti-takeover
provisions in our charter documents and Delaware law could discourage, delay or prevent a change in control of our company and may affect
the trading price of our common stock.

 We
are a Delaware corporation and the anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent
a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three years
after the person becomes an interested stockholder, even if a change in control would be beneficial to our existing stockholders.

 In
addition, our certificate of incorporation and amended and restated bylaws may discourage, delay or prevent a change in our management
or control over us that stockholders may consider favorable. In particular, our certificate of incorporation and amended and restated
bylaws, among other matters:

 permit our
 Board of Directors to issue up to 10,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate;

 provide that all vacancies
 on our Board of Directors, including as a result of newly created directorships, may, except as otherwise required by law, be filled
 by the affirmative vote of a majority of directors then in office, even if less than a quorum;

 provide that stockholders
 seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of
 stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder's
 notice; and

 do not provide for cumulative
 voting rights, thereby allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors
 to elect all of the directors standing for election;

 The
financial and operational projections that we may make from time to time are subject to inherent risks.

 The
projections that our management may provide from time to time (including, but not limited to, those relating to potential peak sales
amounts, product approval, production and supply dates, commercial launch dates, and other financial or operational matters) reflect
numerous assumptions made by management, including assumptions with respect to our specific as well as general business, economic, market
and financial conditions and other matters, all of which are difficult to predict and many of which are beyond our control. Accordingly,
there is a risk that the assumptions made in preparing the projections, or the projections themselves, will prove inaccurate. There will
be differences between actual and projected results, and actual results may be materially different from those contained in the projections.
The inclusion of the projections in this Report should not be regarded as an indication that we or our management or representatives
considered or consider the projections to be a reliable prediction of future events, and the projections should not be relied upon as
such.

 We
do not intend to pay dividends on our common stock.

 We
have never declared or paid any cash dividend on our common stock. We currently intend to retain any future earnings and do not expect
to pay any dividends for the foreseeable future. Therefore, you should not invest in our common stock in the expectation that you will
receive dividends.

 Item 1B.
 Unresolved
 Staff Comments.

 None.

 Item 1C.

 Cybersecurity

 We
recognize the importance of assessing, identifying, and managing material risks associated with cybersecurity threats, as such term is
defined in Item 106(a) of Regulation S-K. These risks include, among other things: operational risks, intellectual property theft, fraud,
extortion, harm to employees or customers and violation of data privacy or security laws.

 Identifying
and assessing cybersecurity risk is integrated into our overall risk management systems and processes. Cybersecurity risks related to
our business, technical operations, privacy and compliance issues are identified and addressed through a multi-faceted approach including
third party assessments, internal IT Audit, IT security, governance, risk and compliance reviews. To defend, detect and respond to cybersecurity
incidents, we, among other things: conduct proactive privacy and cybersecurity reviews of systems and applications, audit applicable
data policies, perform penetration testing using external third-party tools and techniques to test security controls, conduct employee
training, monitor emerging laws and regulations related to data protection and information security and implement appropriate changes.

 Our
risk management program also assesses third party risks, and we perform third-party risk management to identify and mitigate risks from
third parties such as vendors, suppliers, and other business partners associated with our use of third-party service providers. Cybersecurity
risks are evaluated when determining the selection and oversight of applicable third-party service providers and potential fourth-party
risks when handling and/or processing our employee, business or vendor data. In addition to new vendor onboarding, we would perform risk
management during potential third-party cybersecurity compromise incidents, should they occur, to identify and mitigate risks to us from
third-party incidents. In addition, we maintain cybersecurity insurance coverage (first and third-party) with an insurance carrier that
is a leader in the cybersecurity insurance industry.

 Item
2.
 Description
 of Property.

 We
currently lease office space under a short-term lease in Tampa, Florida from which our finance and operations staff work.

 Item
3.
 Legal
 Proceedings.

 On
July 9, 2019, Hedgepath, LLC ("HPLLC"), a significant minority stockholder of the Company, filed a civil action in the Delaware
Court of Chancery (the "Court") captioned Hedgepath, LLC v. Magrab, et al., C.A. No. 2019-0529-JTL (the "Action")
against certain of the Company's current and former directors, and its President and Chief Executive Officer (the "Individual
Defendants"), as well as the Company's majority stockholder, Mayne Pharma Ventures Pty Ltd. ("Mayne Pharma",
and collectively with the Individual Defendants, the "Defendants"). The Company was named as a nominal defendant given the
derivative nature of the claims. On December 3, 2019, HPLLC filed its Verified Amended and Supplemental Complaint (the "Complaint").
As previously disclosed in further detail by the Company, the Complaint asserts various claims, either directly on behalf of HPLLC or
derivatively on behalf of the Company, for alleged breaches of fiduciary duty, violation of Delaware statute, waste, fraudulent misrepresentation,
declaratory judgment, and dilution of stockholder equity arising out of transactions previously entered into between the Company and
Mayne Pharma and Mayne Pharma's relationship with the Company generally. The Complaint seeks unspecified damages and other relief.
Additionally, on March 23, 2020, a Stockholder Class Action Complaint was filed in the Court by Company stockholder and purported class
representative Samuel P. Sears purportedly on behalf of a class of certain holders of the Company's common stock. That lawsuit,
captioned Sears v. Magrab et al., C.A. No. 2020-0215-JTL (the "Putative Class Action"), asserts claims against the
same Defendants (with the exception of the Company), and the facts underlying the claims largely mirror those alleged in the Action.
On December 10, 2020, the Court entered a stipulated Order coordinating the Action and the Putative Class Action (together, the "Coordinated
Actions").

 On
September 9, 2022, HPLLC, Sears, the Company, the Individual Defendants and Mayne Pharma entered into a Stipulation and Agreement of
Compromise, Settlement, and Release, dated and filed with the Court (together with the exhibits thereto, the "Settlement Agreement"),
which the Court approved, and the Settlement Agreement went into effect on December 13, 2022 (the "Effective Date").

to the Settlement Agreement, (i) the Defendants caused $14,250,000 in cash (to be funded via Mayne Pharma's director and officer
insurance) to be paid to the Company (the "Cash Consideration"); (ii) Mayne Pharma surrendered all equity securities in the
Company for cancellation, and will forgive certain debts it is owed by the Company; (iii) stock options and warrants held by the Individual
Defendants were cancelled; (iv) certain intellectual property licenses to and from the Company, on one hand, and Mayne Pharma, on the
other, were converted or terminated, with only certain obligations remaining in place; (v) each of the Individual Defendants retired
from their positions with the Company, including as members of the Company's Board of Directors and management; (vi) the previously-disclosed
Third Amended and Restated Supply and License Agreement, dated December 17, 2018, between the Company and Mayne was cancelled, with the
Company retaining a royalty on future net sales of SUBA-Itraconazole BCCNS in the United States subject to certain contingent payment
obligations; and (vii) various releases were exchanged among the parties to the Coordinated Actions. After the Effective Date, Mayne
Pharma has also agreed it will remain amenable to discussing with the Company, in good faith, the potential licensing and/or sub-licensing
of the JHU Patents (as defined in the Settlement Agreement), for a commercially reasonable licensing fee, to the extent the Company seeks
to engage in such discussions and that it will not take the position that the Company or persons affiliated with the Company, including
Dr. Francis E. O'Donnell, Jr., are prohibited from developing or commercializing Non-SUBA Formulations of Itraconazole for any
cancer or non-cancer indications. Nor shall Mayne Pharma take any action intended to restrict or limit the Company's ability or
efforts to develop or commercialize Non-SUBA Formulations of Itraconazole for any cancer or non-cancer indications.

 Upon
approval by the Court, the Coordinate Actions were deemed fully resolved and all asserted claims were dismissed with prejudice on the
Effective Date.

 We
are not currently subject to any material legal proceedings. However, we may from time to time become a party to various legal proceedings
arising in the ordinary course of our business.

 Item
4.
 Mine
 Safety Disclosures.

 Not
applicable.

 PART
II

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

 Our
common stock is listed for quotation on the OTCQB market under the symbol "INTI". The range of reported high and reported
low sales prices per share for our common stock for each fiscal quarter during 2023 and 2022, as reported by the OTC Markets Group, is
set forth below.

 Quarterly
 common stock Price Ranges

 Fiscal
 Year 2023, Quarter Ended:

 High

 Low

 March 31, 2023

 $
 0.09

 $
 0.06

 June 30, 2023

 $
 0.10

 $
 0.02

 September 30, 2023

 $
 0.05

 $
 0.02

 December 31, 2023

 $
 0.30

 $
 0.04

 Fiscal
 Year 2022, Quarter Ended:

 High

 Low

 March 31, 2022

 $
 0.16

 $
 0.10

 June 30, 2022

 $
 0.15

 $
 0.08

 September 30, 2022

 $
 0.11

 $
 0.05

 December 31, 2022

 $
 0.10

 $
 0.04

 Since
our common stock is not listed on a national exchange, any over-the-counter market quotations shown above reflect inter-dealer prices,
without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.

 As
of the date of this Report, we had approximately 86 holders of record of our common stock. No cash dividends have been paid on the common
stock to date. We currently intend to retain earnings for further business development and do not expect to pay cash dividends in the
foreseeable future.

 Securities
Authorized for Issuance Under Equity Compensation Plans

 The
following table provides information as of December 31, 2023 with respect to the shares of our common stock that may be issued under
our existing equity compensation plan.

 Awards
 under equity compensation plans approved by security holders (1)

 of securities

 to
 be issued upon

 exercise
 of outstanding options,

 warrants
and rights

 price of

 outstanding
 options,

 warrants
 and rights

 of securities

 remaining
 available

 for
 future issuance

 under
 equity

 compensation
 plans

 (excluding
 securities

 reflected
in the first column)

 Sam Sears

 150,000

 $
 0.24

 James McNulty

 150,000

 $
 0.24

 Garrison J. Hasara (2)

 260,000

 $
 0.272

 Debra Peattie (3)

 210,000

 $
 0.05

 Debra Peattie (3)

 1,000,000

 $
 0.05

 Garrison J. Hasara (2)

 100,000

 $
 0.54

 Garrison J. Hasara (2)

 125,000

 $
 0.31

 Debra
 Peattie (3)

 580,646

 $
 0.31

 Total

 2,575,646

 $
 0.09

 8,424,354

 (1)

 The
 2014 Equity Incentive Plan (the "EIP") was adopted by the Board of Directors and approved by a majority of our stockholders
 on September 30, 2014. The Board of Directors approved an increase to the number of shares available for issuance under the EIP of
 11,000,000 shares which was subsequently approved by our majority shareholder in December 2018. As of December 31, 2023, there are
 8,424,354 shares available for issuance under the EIP.

 (2)

 Garrison
 J. Hasara is the former Chief Financial Officer and resigned from such position on December 13, 2022.

 (3)

 Debra
 Peattie is a former Board member and resigned from the Board on June 1, 2022.

 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 related notes appearing elsewhere in this Report. This discussion and analysis contains forward-looking statements
that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking
statements as a result of certain factors, including, but not limited to, those which are not within our control.

 Background
of Our Company

 The
Company is a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics
based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with
certain cancers and certain non-cancerous proliferation disorders. We also have explored and expect to continue to explore acquiring
or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other
diseases based on repurposing active ingredients of already approved drugs.

 Our
current primary focus is on the development of therapies initially for basal cell carcinoma ("BCC"), prostate and lung cancers
in the United States utilizing itraconazole, a drug currently approved by the FDA to treat fungal infections, and which has an extensive
history of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of
cancer patients using itraconazole. In particular, on December 12, 2023, the Company entered into an Exclusive License Agreement (the
"Agreement") with Johns Hopkins University ("JHU"). Pursuant to the Agreement, JHU granted to the Company the
exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled "New Angiogenesis Inhibitors" (the "Patent").
The Patent relates to the treatment of prostate cancer, BCC including basal cell carcinoma nevus syndrome ("BCCNS"), and
lung cancer.

 Critical
Accounting Policies and Estimates

 Estimates

 The
preparation of financial statements 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 financial statements and the reported amounts
of revenues and expenses during the period. Actual results could differ from those estimates.

 Stock-Based
Compensation

 We
account for stock-based awards to employees and non-employees using Financial Accounting Standards Board ("FASB") Accounting
Standards Codification ("ASC") Topic 718 – Accounting for Share-Based Payments, which provides for the use of the fair
value-based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation.
Fair values of restricted stock units issued are determined by the Company based predominantly on the trading price of the common stock
on the date of grant. Fair value of each common stock option is estimated on the date of grant using the Black-Scholes valuation model
that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatility
is based on historical volatility of a peer group's common stock and other factors estimated over the expected term of the options.
The expected term of the options granted is derived using the "simplified method" which computes the expected term as the
average of the weighted-average vesting term and the contract term. The risk-free rate is based on the U.S. Treasury yield.

 Results
of Operations

 For
the Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022

 Research
and Development Expenses. We incurred $1.4 million and $6,150 in research and development expenses during the years ended December
31, 2023 and 2022, respectively. The R&D expenses are primarily internal personnel costs, consisting of salaries, benefits and other
related costs, as well as amounts paid to third parties to support the Company's research and development activities. The increase
in research and development expenses is the result of the relative significance of R&D activity during the year ended December 31,
2023 compared to the year ended December 31, 2022.

 General
and Administrative Expenses. We incurred approximately $2.0 million and $0.7 million in general and administrative expenses during
the years ended December 31, 2023 and 2022, respectively. During the year ended December 31, 2023, general and administrative expenses
were composed primarily of compensation costs of $0.9 million, insurance costs of $0.5 million, professional services fees of $0.5 million
and general corporate overhead costs of $0.1 million. The increase of approximately $1.3 million was due primarily to the increase in
the various G&A costs incurred as a result of the governance and management transitions related to litigation that resolved in late
2022 and the subsequent execution of the Company's operations.

 Gain
on legal settlement. We recognized a $12.6 million gain on legal settlement during the year ended December 31, 2022 related to
a legal settlement awarded to the Company as a result of the resolution of litigation, along with various other items stipulated within
the Settlement Agreement, including legal costs incurred relating to the litigation and forgiveness of certain balances previously owed
to the defendants. There was no such gain on legal settlement during the year ended December 31, 2023.

 Gain
on forgiveness of legal fees. We recognized a $0.2 million gain on forgiveness of legal fees during the year ended December 31,
2022 related to the forgiveness of accumulated legal fees owed to external legal counsel. There was no such gain on forgiveness of legal
fees during the year ended December 31, 2023.

 Interest
expense. We incurred approximately $23,000 in interest expense during the year ended December 31, 2022 related to the outstanding
notes payable to Mayne Pharma. There was no such interest incurred during the year ended December 31, 2023 due to the legal settlement
with Mayne Pharma and repayment of the notes payable.

 Interest
income. We recognized approximately $0.4 million of interest income during the year ended December 31, 2023. The interest income
was generated from the proceeds resulting from the legal settlement received by the Company in December 2022 which earned interest within
the Company's depository accounts during the period. There was no such interest income earned during the year ended December 31,
2022.

tax expense. We incurred approximately $55,000 in income tax expense during the year ended December 31, 2022 due to the state
and federal income taxes owed as a result of the taxable income generated from the legal settlement awarded to the Company. There was
no income tax expense incurred during the year ended December 31, 2023.

 Liquidity
and Capital Resources

 We
are presently focused on our business plan of developing and ultimately commercializing innovative therapeutics based on already approved
active pharmaceuticals that have patent-protected methods of use and/or methods of delivery. We expect to progress with the FDA in 2024
to reach a conclusion on whether any additional clinical trials are required before submitting our New Drug Application (NDA). Our current
cash on hand, approximately $8.8 million on December 31, 2023, is sufficient to continue to execute our business plan as currently anticipated,
without another required clinical trial. Based on our current operational plan and budget, we expect that we will have sufficient cash
to manage our business and continue to pursue clinical trials and acquire other drug development opportunities, as needed once we determine
our requirements for the BCCNS product. As we determine capital requirements for additional opportunities, we will consider raising additional
capital in the public market.

 Contractual
Obligations and Commercial Commitments

 In accordance with the Exclusive License Agreement (the "Agreement") with Johns Hopkins University ("JHU"),
we are contractually obligated to make Minimum Annual Royalty ("MAR") payments to JHU, as defined within the Agreement. As
of December 31, 2023, the remaining MAR payments owed are as follows: By January 1, 2025: $10,000; By January 1, 2026: $15,000; By January
1, 2027 and every year thereafter until the first commercial sale of an associated licensed product: $50,000.

 Item
7A.
 Quantitative
 and Qualitative Disclosures About Market Risk.

 We
are a "smaller reporting company" as defined by Regulation S-K and as such, are not required to provide the information contained
in this item pursuant to Regulation S-K.

 Item
8.
 Financial
 Statements and Supplementary Data.

 Our
Financial Statements and Notes thereto and the report of Cherry Bekaert LLP, our independent registered public accounting firm (PCAOB
ID 677), are set forth beginning on page F-1 of this Report.

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

 None.

 Item
9A.
 Controls
 and Procedures.

 Evaluation
of Disclosure Controls and Procedures

 Under
the supervision and with the participation of our management, including our Chief Executive Officer and our Interim Chief Financial Officer,
we carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in
Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, our Chief Executive Officer and our Interim Chief Financial
Officer have concluded that, at December 31, 2023, such disclosure controls and procedures were effective.

 Disclosure
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our
reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified
in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed
to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated
to management, including our Chief Executive Officer and Interim Chief Financial Officer, or persons performing similar functions, as
appropriate, to allow timely decisions regarding required disclosure.

 Limitations
on the Effectiveness of Controls

 Our
disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure
control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance
that all control issues, if any, within a company have been detected. Our Chief Executive Officer and Interim Chief Financial Officer
have concluded that, based on their evaluation as of the end of the period covered by this Report, our disclosure controls and procedures
were effective.

 Changes
in Internal Control over Financial Reporting

 There
were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2023 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 Management's
Report on Internal Control Over Financial Reporting

 As
required by the SEC rules and regulations for the implementation of Section 404 of the Sarbanes-Oxley Act, our management is responsible
for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is
designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements
for external reporting purposes in accordance with U.S. GAAP. Our internal control over financial reporting includes those policies and
procedures that:

 (1)

 pertain
 to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the
 assets of our company,

 (2)

 provide
 reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with
 accounting principles generally accepted in the United States of America, and that our receipts and expenditures are being made only
 in accordance with authorizations of our management and directors, and

 (3)

 provide
 reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that
 could have a material effect on the financial statements.

 In
the course of completing its assessment of internal control over financial reporting as of December 31, 2023, management did not identify
any material weaknesses but did identify a significant deficiency in the number of personnel available to serve the Company's accounting
function, specifically management believes that we may not be able to adequately segregate responsibility over financial transaction
processing and reporting. A significant deficiency is a deficiency, or a combination of deficiencies, in internal control over financial
reporting, that is less severe than a material weakness yet important enough to merit attention by those responsible for oversight of
the Company's financial reporting. Although we are unable to remediate the significant deficiency with current personnel, we are
mitigating its potential impact, primarily through greater involvement of senior management in the review and monitoring of financial
transaction processing and financial reporting.

 Management
assessed the effectiveness of our internal control over financial reporting at December 31, 2023. In making these assessments, management
used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control —
Integrated Framework. Based on our assessments and those criteria, management determined that we maintained effective internal control
over financial reporting at December 31, 2023.

 Item
9B.
 Other
 Information.

 None

 Item
9C.
 Disclosure
 Regarding Foreign Jurisdictions that Prevent Inspections.

 Not
applicable.

 PART
III

 Item
10.
 Directors,
 Executive Officers and Corporate Governance.

 Our
directors and executive officers and their ages as of the date of this Report are as follows:

 Name

 Age

 Position

 E. O'Donnell

 Executive
 Chairman of the Board and Chief Executive Officer

 James
 A. McNulty

 Interim
 Chief Financial Officer, Treasurer and Secretary

 Samuel
 J. Sears

 Niraj
 Vasisht

 Michelle
 Yanez

 Michael
 Jerman

 and Audit Committee Financial Expert

 Ronald
 E. Osman

 There
are no family relationships between any of our directors or executive officers.

 To
the best of our knowledge, during the past ten years, none of the following occurred with respect to a present director or executive
officer of the Company: (1) any bankruptcy petition filed by or against any business of which such person was a general partner or executive
officer either at the time of the bankruptcy or within two years prior to that time; (2) any conviction in a criminal proceeding or being
subject to a pending criminal proceeding (excluding traffic violations and other minor offenses); (3) being subject to any order, judgment
or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining,
barring, suspending or otherwise limiting his or her involvement in any type of business, securities or banking activities; (4) being
found by a court of competent jurisdiction (in a civil action), the SEC or the Commodities Futures Trading Commission to have violated
a federal or state securities or commodities law, and the judgment has not been reversed, suspended or vacated; (5) being subject of,
or a party to, any Federal or State judicial or administrative order, judgment, decree or finding relating to an alleged violation of
the federal or state securities, commodities, banking or insurance laws or regulations or any settlement thereof or involvement in mail
or wire fraud in connection with any business entity not subsequently reversed, suspended or vacated and (6) being subject of, or a party
to, any disciplinary sanctions or orders imposed by a stock, commodities or derivatives exchange or other self-regulatory organization.

E. O'Donnell, Jr. M.D. is the founder of several specialty pharmaceutical companies. He is the founder of BioDelivery Sciences
Int. Inc (BDSI: NASDAQ) and served in various leadership positions including President, CEO, Executive Chairman, and Chairman at the
Company. BDSI was acquired by Collegium Pharmaceuticals in April 2022. He is also the founder of Repurposed Therapeutics, Inc (RPTI dba
Defender Pharma). RPTI is a privately-held pharma company which has partnered with the Dept. of Defense and the National Aeronautical
and Space Administration (NASA) to develop pharmaceuticals (such as intranasal scopolamine for the prevention of motion sickness) and
chemical countermeasures to address unmet medical needs in operational personnel. Since September 2014, he has served as Executive Chairman.
Dr. O'Donnell is also the founder of the Company (then called Hedgepath Pharmaceuticals, Inc. with OTCQB stock symbol HPPI) where
he served as Executive Chairman until 2016. Dr. O'Donnell is a graduate of the Johns Hopkins university (BS) and the JHU School
of Medicine (MD). He received his specialty training at the Wilmer Ophthalmologic Institute. He is the former Professor and Chairman
of the Dept. of Ophthalmology, St. Louis University School of Medicine. He served on the Board of Trustees of St. Louis University for
over 17 years. He is an inventor or co-inventor on over twenty patents, including patents assigned to the Company.

 James
A. McNulty, CPA, was CFO of Mira Pharmaceuticals, Inc. and Telomir Pharmaceuticals, Inc. prior to the respective initial public offerings
of the companies in 2023 and 2024. Mr. McNulty was the CEO of MYMD Pharmaceuticals, Inc. until it became a public company in 2020. After
leaving public accounting in 1998 after a 26-year career in Tampa as founder of three CPA firms, he served as CFO in the biopharmaceutical
industry including 15 years with BioDelivery Sciences International, Inc. (NASDAQ: BDSI). He served five years on the board as Lead Director/Audit
Committee Chair of CV Sciences, Inc (OTC: CVSI). He has extensive experience in privately held companies, including five years as a Director
of Quantum Technology Sciences, Inc. until its acquisition by a public company, and since 2000 as CFO of Hopkins Capital Group, an affiliation
of limited liability companies which engage in venture activities primarily in the development of pharmaceuticals, including CFO of Defender
Pharmaceuticals, Inc. He is a partner in Perfect Golf Event, LLC, an online organizer of approximately 5,000 charity golf events annually.
Mr. McNulty's career in accounting and consulting services includes expert testimony as a Certified Public Accountant, primarily
in construction litigation and personal injury cases. He is a 1972 graduate of the University of South Florida.

 Samuel
J. Sears, Jr. has been a corporate attorney for over 40 years and is currently Of Counsel to the Boston law firm Cetrulo LLP, a position
he has held since 2019; he was Managing Partner of that firm from 2006 through 2018. He was also Managing Partner of the Boston law firm
Burns & Levinson from 1981 to 1993. Mr. Sears has extensive experience as a member of the Board of Directors of publicly owned corporations.
He was a Director of Hedgepath Pharmaceuticals, Inc. (predecessor of the Company) and its predecessor, Commonwealth Biotechnologies,
Inc. from 1998 to 2017, serving as Chairman of its Compensation Committee from 2012 to 2017. He has been a Director of six other publicly
owned corporations, including, most recently, BioDelivery Sciences International, Inc. (Chairman of the Compensation Committee) from
2011 to 2017. Mr. Sears is a 1965 graduate of Harvard College and a 1968 graduate of Boston College Law School.

 Niraj
Vasisht, PhD, has been the Chairman of Board, President and CEO of Avior Bio Inc. since March 2018. He has over thirty years of experience
in the pharmaceutical industry. Under his leadership, he built Avior into a clinical-stage, a manufacturing-integrated pharmaceutical
company that is developing a treatment for pruritus and skin inflammation for patients suffering from chronic liver and kidney diseases.
Before Avior, Dr. Vasisht was the Chief Technology Officer at BioDelivery Sciences (BDSI). He spent 13 years in multiple roles and oversaw
the development, approval, and manufacturing of Belbuca, Bunavail, and Onsolis for the US and ROW market addition. Before
BDSI, he was the Director at Southwest Research Institute', where he ran the pharmaceutical and nanomaterials business unit. At
Southwest Research, he developed several drug delivery technologies and assisted the development of third-party commercial products,
i.e., Citracal, Meg-3, and Probuphine. Dr. Vasisht received a bachelor degree in Chemical Engineering from the Indian
Institute of Technology, India, and a Doctorate in Chemical Engineering from Rensselaer Polytechnic Institute. He has over 25 US patents
and numerous publications and authored a book on Microencapsulation and Controlled Release.

 Michelle
Yanez, MBA, is a senior financial executive with over 25 years of experience in public and privately held biotech, pharmaceuticals,
and life science companies. She currently serves as CFO of MIRA Pharmaceuticals, Inc. and Controller of Telomir Pharmaceuticals, Inc.
(NASDAQ: MIRA/TELO). Ms. Yanez' experience includes a broad range of responsibilities in a highly complex and regulated market.
She also brings deep corporate governance experience through her work with corporate boards, including audit and finance committees and
is qualified to serve on audit committees as a financial expert. Ms. Yanez held various positions, including the Director of Financial
Reporting, of BioDelivery Sciences International, Inc., (Nasdaq: BDSI). In her role, she led financial offerings, managed due diligence
for product acquisitions and financings and managed finance documents and filings for the tender offer, leading to the acquisition of
BDSI in April 2022 for over $600M. Ms. Yanez is a member of the Institute of Management Accountants and a member of the SEC Professionals
Group. Ms. Yanez received her MBA from Rutgers School of Business, Cum Laude.

 Michael
Jerman, CPA, has previously been a chief financial officer of multiple private equity-backed companies in the energy, Software as
a Service (SaaS), and manufacturing industries, was a Captain with the United States Air Force and was a Director with PricewaterhouseCoopers
(PwC) in the US and UK. He was a member of the PwC national office within the SEC PCAOB quality group supporting Europe and the EMEA
regions with complex accounting and audit consultations. He has significant experience in a wide variety of technical accounting and
finance matters as well as stakeholder management. He has specialized in rapid project mobilization and deployment of skilled resources
for emergency issues, design, and implementation of small to large scale assurance requirements and advisory projects. The Company believes
Mr. Jerman is qualified to serve on the Board and as a qualified financial expert on the Company's Audit Committee due to his substantial
experience with the SEC PCAOB quality group at PwC and his experience assisting public reporting companies with their annual and quarterly
requirements.

 Ronald
E. Osman is the founder of Ronald E. Osman & Associates, Ltd. He has been a licensed attorney for over 40 years, representing
clients in a variety of issues before both state and federal courts. His practice has concentrated on complex civil litigation, including
actions brought under the Federal False Claims Act which resulted in recovery of over $500 Million for Medicare, Medicaid, and other
federal health insurance programs. He has provided expert testimony to the United States Senate and numerous federal courts regarding
the Federal False Claims Act and has been actively involved in drafting and modifying both federal and state legislation, including the
Federal False Claims Act, Liability Standards for Medicare Contractors, and the Illinois Hydraulic Fracturing Regulatory Act. In addition
to his law practice, Mr. Osman is Chairman of the Board of Cell Culture, Inc. (C3), one of the founders of Rural Health, Inc., a not-for-profit
Illinois corporation that provides medical services to patients in southern Illinois counties, and he supports the efforts of several
charitable not-for-profits in Missouri and Illinois. He has been involved in efforts with the United States Department of Health and
Human Services and Federal Drug Administration related to standards for use in testing and approving cancer treatment methods. Prior
to becoming an attorney, Mr. Osman served in the United States Marine Corp, where he was a Commanding Officer of Artillery Battery and
Headquarters Company and received an Officer of the Deck qualification from the U.S. Navy. Additionally, both prior to becoming an attorney
and concurrently with his practice of law, Mr. Osman worked in the agriculture industry, starting as a farm laborer on his father's
vegetable farm at age 12 and going on to own and operate an approximate 5,000 acre farming operation with his brother and to own and
lease approximately 5,160 acres of farm ground in the State of Bahia, Brazil.

 Board
Committees and Director Independence

Independence

 Of
our current directors, we have determined that Samuel J. Sears, Jr., Niraj Vasisht, Michelle Yanez and Michael Jerman are "independent"
as defined by NASDAQ Stock Market rules. Accordingly, a majority of our Board of Directors is "independent."

 Board
Committees

 Our
Board of Directors has established four standing committees – Audit, Nominating and Corporate Governance, Compensation and a Scientific
Advisory Board. All standing committees operate under a charter that has been approved by our Board of Directors.

 Audit
Committee

 Our
Board of Directors has an Audit Committee established in accordance with Section 3(a)(58)(A) of the Exchange Act, composed of Samuel
J. Sears, Jr., Niraj Vasisht, Michelle Yanez and Michael Jerman. All members are independent directors as defined in accordance with
Rule 10A-3 of the Exchange Act and the rules of the NASDAQ Stock Market. Mr. Jerman serves as chairman of the committee. The Board of
Directors has determined that Mr. Jerman is an "audit committee financial expert" as defined in Item 407(d)(5)(ii) of Regulation
S-K.

 Our
Audit Committee oversees our corporate accounting, financial reporting practices and the audits of financial statements. For this purpose,
the Audit Committee has a charter (which is reviewed annually) and performs several functions. The Audit Committee:

 evaluates
 the independence and performance of, and assesses the qualifications of, our independent auditor and engages such independent registered
 public accounting firm;

 approves
 the plan and fees for the annual audit, quarterly reviews, tax and other audit-related services and approves in advance any non-audit
 service and fees therefor to be provided by the independent registered public accounting firm;

 monitors
 the independence of the independent registered public accounting firm and the rotation of partners of the independent auditor on
 our engagement team as required by applicable regulations;

 reviews
 the financial statements to be included in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and reviews with management
 and the independent registered public accounting firm the results of the annual audit and reviews of our quarterly financial statements;
 and

 provides
 oversight assistance in connection with legal, ethical and risk management compliance programs established by management and the
 board, including compliance with requirements of Sarbanes-Oxley and makes recommendations to the Board of Directors regarding corporate
 governance issues and policy decisions.

 Nominating
and Corporate Governance Committee

 Our
Board of Directors has a Nominating and Corporate Governance Committee composed of Samuel J. Sears, Jr., Niraj Vasisht, Ph. D., and Michelle
Yanez. Dr. Vasisht serves as the chairman of the committee. The Nominating and Corporate Governance Committee is charged with the responsibility
of reviewing our corporate governance policies and with proposing potential director nominees to the Board of Directors for consideration.
The Nominating and Corporate Governance Committee has a charter which is reviewed annually. All members are independent directors in
accordance with the rules of the NASDAQ Stock Market. The Nominating and Corporate Governance Committee will consider director nominees
recommended by security holders.

 Compensation
Committee

 Our
Board of Directors also has a Compensation Committee, which reviews or recommends the compensation arrangements for our management and
employees and assists the Board of Directors in reviewing and approving matters such as company benefit and insurance plans, including
monitoring the performance thereof. The Compensation Committee has a charter (which is reviewed annually) and is composed of three members:
Samuel J. Sears, Jr., Niraj Vasisht, Ph. D., and Michelle Yanez. Mr. Sears serves as chairman of this committee. All members are independent
in accordance with rules of the NASDAQ Stock Market.

 Scientific
Advisory Board

 On
October 13, 2023, the Board of Directors created a Scientific Advisory Board ("SAB") to provide input and advice to the Company's
management and to the Board on various aspects of the Company's clinical development activities and strategies. The duties of the
SAB will include but are not limited to advising the Board regarding endorsement to current and planned research and development programs,
validating timelines, budget and key milestones; advising the Board about the progress on the approved research and development activities;
advising the Board regarding the scientific merit of compounds for licensing and acquisition opportunities; providing strategic advice
regarding emerging science, therapeutic trends and foreseeable opportunities; and providing advice to the Company's scientific
team on aspects of the programs as requested.

 The
Board has entered into a form of consulting agreement with Dr. Elizabeth Billingsley for provision of consulting services related to
the Company's clinical development activities. The Board has appointed Dr. Billingsley as the initial member and Chairperson of
the SAB, to be compensated for her time and efforts on behalf of the Company's SAB pursuant to the terms of the consulting agreement.

 Dr.
Elizabeth M. Billingsley, MD, is a Professor of Dermatology with Penn State Health Hershey Medical Center, and Penn State College
of Medicine. She received her undergraduate degree from Cornell University and her medical degree from Penn State University College
of Medicine. She is a Mohs micrographic surgeon with more than 30 years' experience in Mohs Surgery and skin cancer management.
She also has performed numerous clinical trials related to skin cancer. Dr Billingsley is a past president of the American College of
Mohs Surgery. She is affiliated with the Gorlin Syndrome Alliance and is a member of their Medical and Scientific Advisory Committee.

 Dr.
Marc D. Brown, MD, completed a dermatology residency at the University of Michigan in 1987. Following this came a two-year fellowship
training for Mohs Surgery and Cutaneous Oncology. He joined the faculty at the University of Rochester Medical Center in 1989 and is
a tenured professor of Dermatology and Oncology and is a member of the Wilmot Cancer Center. He served as the director of the Dermatology
Residency Program and the Mohs Surgery Fellowship Program at the Rochester Medical Center. He has been included in the Best Doctors in
America directory and has published a lengthy list of literature. Dr. Brown performs Mohs surgery on over 2,000 patients per year and
has performed a total of more than 50,000 Mohs procedures.

 Dr.
Allison Vidimos, RPH, MD, was appointed Chairman of the Department of Dermatology at Cleveland Clinic 2005 and Vice Chairman of the
Dermatology and Plastic Surgery Institute in 2006. She was appointed Professor of Dermatology, Cleveland Clinic Lerner College of Medicine,
Case Western Reserve University in 2011. She became the program director of the Micrographic Surgery and Dermatologic Oncology fellowship
in 2013. She was a member of the Scientific Assembly Committee and Membership Committee for the American Academy of Dermatology (AAD)
2012-17. She was elected to the Board of Directors of the AAD in 2022. She served as President of the American College of Mohs Surgery
(ACMS) in 2017-2018. Dr. Vidimos received the Frederic Mohs Lifetime Achievement Award in 2021. She was appointed to the Board of Directors
for the American Board of Dermatology for 2019-2027 and is a member and Chairman of the board question writing committee for dermatologic
surgery. She was elected to the Board of Directors of the Ohio Dermatological Association (ODA) in 2019-21 and is President of ODA 2022-23.
Her clinical practice and research encompass skin cancer prevention, diagnosis and treatment, and patient safety.

 Dr.
Sean R. Christensen, MD, PhD, is an Associate Professor of Dermatology; Director of Resident Education in Dermatologic Surgery; Director
of Dermatologic Surgery at Yale Dermatology-Branford. Dr. Christensen has been practicing dermatologic surgery since completing training
in 2013. His surgical specialization includes Mohs surgery, treatment of early-stage melanoma, and surgical reconstruction. Additionally,
Dr. Christensen focuses on complex skin cancer issues such as field characterization, preventative strategies in high-risk patients and
management of advanced or aggressive skin cancer. Dr. Christensen has published extensively on skin cancer pathogenesis and treatment
and has experience in clinical trials for basal cell carcinoma. He is a frequent lecturer at national meetings for organizations such
as the American Academy of Dermatology and the American College of Mohs surgery, and currently serves as the Treasurer for the International
Transplant Skin Cancer Collaborative.

 Dr.
Iam Maher, MD, is a Professor of Dermatology and Director of Dermatologic Surgery at University of Minnesota. He is board certified
in Mohs surgery, specializing in the treatment of a broad range of common and rare skin cancers as well as post-skin cancer reconstruction.
Dr. Maher has served on the Boards of multiple national Dermatologic organizations. He has published over 100 peer-reviewed articles.

 Following
the formation of the SAB, the members were tasked with reviewing the clinical study report SCORING Trial: Phase 2(b) Open-Label Trial
of SUBATM-Itraconazole in Subjects with Basal Cell Carcinoma Nevus Syndrome and answering a series of three questions, as detailed in
the Q&A below:

 1)
Question: Do you agree that multiple BCC tumors in each patient represent distinct tumors and not metastatic lesions?

 Answers:

 Dr.
Ian Maher: Yes. Absolutely.

 Dr.
Allison Vidimos: Yes.

 Dr.
Elizabeth Billingsley: Yes.

 Dr.
Marc Brown: Correct, multiple BCC tumors are NOT metastatic lesions. Mets with highly aggressive BCCs is extremely rare. Certainly,
BCC tumors can be locally recurrent, but that is different than metastatic spread.

 Dr.
Sean Christensen: Yes. I agree that the multiple tumors in each patient in this trial were all independent, primary tumors. They were
not metastatic. Each of these tumors within a single patient likely has a slightly different mutational profile and may respond different
to therapy.

 2)
Question: As such, should an efficacy assessment be based on the effects on each tumor rather than be limited to aggregate effects on
each patient (so called RECIST criteria)?

 Answers:

 Dr.
Ian Maher: The development of some new tumors in BCCNS is expected. Maintaining stability of disease alone, even if in a subset of tumors,
is a valid and valuable outcome for Gorlin patients. Tumors that are prevented from growing are less likely to require surgery or further
disfigurement/disability thus decreasing the burden of disease on the patient in terms of syndrome associated costs and QOL.

 Dr.
Allison Vidimos: Each tumor.

 Dr.
Elizabeth Billingsley: Yes.

 Dr.
Marc Brown: Efficacy assessment is best done on distinct tumors. An aggregate assessment could also be performed, but not at the exclusion
of measuring distinct BCC tumors, which should be the primary measurement.

 Dr.
Sean Christensen: Yes, I believe it is reasonable to perform an analysis of response of individual tumors, rather than individual patients.
In such an analysis based on individual tumors, 57.7% of 477 tumors had a partial response, defined as at least a 30% reduction in diameter,
and 27.3% of individual tumors had a complete response.

 3)
Question: Do you believe that this clinical study supports the proposition that Itraconazole is a clinically useful option as part of
therapeutic management of BCC's in Gorlin Syndrome (BCCNS)?

 Answers:

 Dr.
Ian Maher: Yes. While the efficacy as rated in this study may be slightly lower than vismo, the tolerability seems to be better. In my
mind that makes it a viable and valuable alternative.

 Dr.
Allison Vidimos: Yes.

 Dr.
Elizabeth Billingsley: Management of Gorlin patients requires multiple modalities and approaches – surgical, medical, laser, topical
treatments. Any approach that can decrease the tumor burden through limiting growth of current lesions, or the prevention of development
of new lesions is of significant benefit to these patients. The surgical fatigue and disfigurement can be lessened by decreasing the
absolute number of tumors that need surgery, even if by 25%.

 Dr.
Marc Brown: Yes, based on these results, itraconazole is a clinically useful option. Given the fact that Gorlin syndrome is a long-term
chronic condition, any drug that even shows a modest benefit clinically would be a welcome addition. Surgical fatigue is a real problem
in this patient population; thus, medical interventions are beneficial. If the drug is affordable and with minimal side effects, all
the better. As an example, look at the popularity of nicotinamide to decrease new SCCs; despite showing less than a 25% decrease, it
has been widely embraced. Even if there is a modest benefit to itraconazole to decrease the tumor size or the development of new BCC
tumors, it would be advantageous and beneficial to Gorlin patients.

 Dr.
Sean Christensen: Yes, I believe that this clinical study (particularly when analyzed by response of individual tumors) supports the
use of itraconazole as a therapy in Gorlin syndrome. However, I do not know that the FDA will respond to a tumor-based analysis such
as this when it was not a primary endpoint of the trial. I'm sure this is worth some additional discussion.

 Board
Meetings and Attendance

 The
Board of Directors held three meetings in 2023. The Audit, Nominating and Corporate Governance, and Compensation Committees met
three times in 2023, convening each time there was a meeting of the Board of Directors. The Scientific Advisory Board, which was
created on October 13, 2023, convened once for a formal meeting in 2023. All directors attended the meetings of the Board for the
periods in which they were directors.

 Section
16(a) Beneficial Ownership Reporting Compliance

 Section
16(a) of the Exchange Act requires that our directors and executive officers and persons who beneficially own more than 10% of our common
stock (referred to herein as the "reporting persons") file with the SEC various reports as to their ownership of and activities
relating to our common stock. Such reporting persons are required by the SEC regulations to furnish us with copies of all Section 16(a)
reports they file.

 Based
solely upon a review of copies of Section 16(a) reports and representations received by us from reporting persons, and without conducting
any independent investigation of our own, in fiscal year 2023, all Forms 3, 4 and 5 were timely filed with the SEC by such reporting
persons.

 Code
of Ethics

 We
have adopted a formal code of ethics that applies to our directors and principal executives and financial officers or persons performing
similar functions. A copy of our Code of Ethical Conduct can be found on our website under "Investors" at

 Item
11.
 Executive
 Compensation.

 The
following table sets forth all compensation paid to our named executive officers at the end of the fiscal years ended December 31, 2023
and 2022. Individuals we refer to as our "named executive officers" include our Executive Chairman and Chief Executive Officer
and our Interim Chief Financial Officer, Secretary and Treasurer.

 Name
 and principal position

 Year

 Salary
 ($)

 Bonus
 ($)

 Stock
 Awards ($)

 Option
 Awards ($)

 Non-
 Equity Incentive Plan Compensation ($)

 Nonqualified
 Deferred Compensation Earnings ($)

 All
 Other Compensation ($)

 Total
 ($)

 Francis E. O'Donnell

 2023

 $
 598,000

 $
 408,002

 -

 -

 -

 -

 $
 83,335

 $
 1,089,337

 Executive Chairman and Chief
 Executive Officer (1)

 2022

 $
 30,000

 -

 -

 -

 -

 $
 155,644
 (3)

 -

 $
 185,644

 James A. McNulty

 2023

 $
 200,000

 $
 113,717

 -

 -

 -

 -

 $
 24,241

 $
 337,958

 Interim Chief Financial Officer,
 Secretary and Treasurer (2)

 2022

 $
 10,270

 -

 -

 -

 -

 $
 52,055
 (3)

 -

 $
 62,325

 (1)

 E. O'Donnell was appointed as Executive Chairman and Chief Executive Officer on December 13, 2022.

 (2)

 James
 A. McNulty was appointed as Interim Chief Financial Officer, Secretary and Treasurer on December 13, 2022.

 (3)

 Includes
 compensation for the period between the date of stipulation and date of settlement prior to the appointment as an executive officer
 of the Company.

 Narrative
Disclosure to Summary Compensation Table

 Employment
Agreements

 Except
as set forth below, we currently have no written employment agreements with any of our officers, directors, or key employees.

E. O'Donnell, Executive Chairman and Chief Executive Officer

 On
December 13, 2022, pursuant to Dr. O'Donnell's appointment as Executive Chairman of the Board and Chief Executive Officer,
the Company entered into an employment agreement with Dr. O'Donnell (the "FEO Employment Agreement"). In addition to
his duties as a director and officer of the Company, Dr. O'Donnell's duties shall include clinical development, corporate
development, intellectual property, and licensing. The FEO Employment Agreement is not for a definite time period, but rather, will continue
until terminated in accordance with its terms. Pursuant to the FEO Employment Agreement, Dr. O'Donnell will earn $598,000 per year.
Dr. O'Donnell shall also be entitled to a sign-on bonus for his services related to the change of control of the Company. In addition,
Dr. O'Donnell shall be eligible to receive a discretionary annual bonus based on his achievement of performance objectives as mutually
agreed between Dr. O'Donnell and the Board. The FEO Employment Agreement further provides that Dr. O'Donnell is entitled
to participate in any employee benefit plans that the Company has adopted or may adopt. Dr. O'Donnell did not receive any equity
compensation in connection with his appointment as Executive Chairman and CEO of the Company.

 The
FEO Employment Agreement is terminable for "Cause" (as defined in the FEO Employment Agreement) or without "Cause"
by the Company, and for "Good Reason" (as defined in the FEO Employment Agreement) or voluntarily by Dr. O'Donnell.
In the event of Dr. O'Donnell death or disability, or termination for "Cause" by the Company or without "Good
Reason" by Dr. O'Donnell, Dr. O'Donnell (or his estate) is entitled to receive any unpaid base salary through the termination
date, reimbursement for unreimbursed business expenses, accrued but unused vacation time in accordance with the Company's policy
and any other payments or benefits that Dr. O'Donnell as entitled to in accordance with any Company benefit plans (collectively,
the "Accrued Benefits"). Upon termination without "Cause" (other than by reason of death or disability) or resignation
for "Good Reason," Dr. O'Donnell will be entitled to receive an amount equal to two times the sum of his annual base
salary and target annual bonus, in addition to all Accrued Benefits. Any outstanding unvested securities owned by Dr. O'Donnell
on the termination date will vest (or terminate) in accordance with the terms of such grant.

 James
A. McNulty, Interim Chief Financial Officer, Treasurer and Secretary

 On
December 13, 2022, pursuant to Mr. McNulty's appointment as Interim Chief Financial Officer and Treasurer, the Company entered
into an employment agreement with Mr. McNulty (the "JAM Employment Agreement"). The JAM Employment Agreement is not for a
definite time period, but rather, will continue until terminated in accordance with its terms. Pursuant to the JAM Employment Agreement,
Mr. McNulty will earn $200,000 per year. Mr. McNulty shall also be entitled to a sign-on bonus for his services related to the change
of control of the Company. In addition, Mr. McNulty shall be eligible to receive a discretionary annual bonus based on his achievement
of performance objectives as mutually agreed between Mr. McNulty and the Board. The JAM Employment Agreement further provides that Mr.
McNulty is entitled to receive a long-term incentive bonus and participate in any employee benefit plans that the Company has adopted
or may adopt. Mr. McNulty did not receive any equity compensation in connection with his appointment as Interim CFO of the Company.

 The
JAM Employment Agreement is terminable for any or no particular reason or cause, In the event of termination of the JAM Employment Agreement
by either party, Mr. McNulty (or his estate) is entitled to receive any unpaid base salary through the termination date, reimbursement
for unreimbursed business expenses, accrued but unused vacation time in accordance with the Company's policy and any other payments
or benefits that Mr. McNulty as entitled to in accordance with any Company benefit plans. Any outstanding unvested securities owned by
Mr. McNulty on the termination date will vest (or terminate) in accordance with the terms of such grant.

 Outstanding
equity awards

 The
following table summarizes outstanding unexercised options held by each of our named executive officers and directors, as of December
31, 2023. There were no outstanding unvested stock or equity incentive plan awards held by our named executive officers, as of December
31, 2023.

 OPTION
 AWARDS

 STOCK
 AWARDS

 Name

 of Securities Underlying Unexercised Options (#) Exercisable

 of Securities Underlying Unexercised Options (#) Unexercisable

 Equity
 Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)

 Options
 Exercise Prices ($)

 Option
 Expiration Date

 of Shares or Units of Stock That Have Not Vested (#)

 Market
 Value of Shares or Units of Stock That Have Not Vested ($)

 Equity
 Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Been
 Issued (#)

 Equity
 Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That
 Have Not Been Issued ($)

 Samuel J. Sears
 Jr.

 150,000

 —

 —

 $
 0.24

 July 1, 2026

 —

 —

 —

 —

 James A. McNulty

 150,000

 —

 —

 $
 0.24

 July 1, 2026

 —

 —

 —

 —

 2014
Equity Incentive Plan

 In
July 2014, our Board of Directors adopted our EIP. On September 30, 2014, the EIP was approved by the majority of stockholders pending
delivery of required notice to all Company stockholders. On December 31, 2018, the EIP was comprised of 32,583,475 shares. In December
2018, the Board of Directors approved an increase to the number of shares available for issuance under the EIP of 11,000,000 shares which
was subsequently approved by our majority shareholder in December 2018, resulting in a total of 43,583,475 shares available for issuance
under the EIP (ranking pari passu with our issued and outstanding common stock) to be available in the form of incentive stock options,
non-qualified stock options, restricted stock, restricted stock units, performance awards and other customary equity incentives.

 The
purpose of our EIP is to attract and retain directors, officers, consultants, advisors, and employees whose services are considered valuable,
to encourage a sense of proprietorship and to stimulate an active interest of such persons in our development and financial achievements.
The EIP is administered by the Compensation Committee of our Board of Directors or by the full Board of Directors, which may determine,
among other things, (a) the persons who are to receive awards, (b) the type or types of awards to be granted to such persons, (c) the
number of shares of common stock to be covered by, or with respect to which payments, rights, or other matters are to be calculated in
connection with the awards, (d) the terms and conditions of any awards, (e) whether, to what extent, and under what circumstances awards
may be settled or exercised in cash, shares of common stock, other securities, other awards or other property, or canceled, forfeited,
or suspended and the method or methods by which awards may be settled, exercised, canceled, forfeited, or suspended, (f) whether, to
what extent, and under what circumstances the delivery of cash, shares of common stock, other securities, other awards or other property
and other amounts payable with respect to an award, (g) interpret, administer, reconcile any inconsistency in, settle any controversy
regarding, correct any defect in and/or complete any omission in the EIP and any instrument or agreement relating to, or award granted
under, the EIP, (h) establish, amend, suspend, or waive any rules and regulations and appoint such agents as the Compensation Committee
deems appropriate for the proper administration of the EIP, (i) accelerate the vesting or exercisability of, payment for or lapse of
restrictions on, awards and (j) make any other determination and take any other action that the compensation committee deems necessary
or desirable for the administration of the EIP.

 The
EIP provides that in the event of a change of control event, (i) all of the then outstanding options and stock appreciation rights granted
pursuant to the EIP will immediately vest and become immediately exercisable as of a time prior to the change in control, (ii) any performance
goal restrictions related to an award will expire as of a time prior to the change in control and (iii) any performance periods that
relating to an award which have not yet expired on the date the change in control occurs will end on such date, and the compensation
committee will (a) determine the extent to which performance goals with respect to each such performance period have been met based upon
such audited or unaudited financial information or other information then available as it deems relevant and (b) cause the relevant participant
to receive partial or full payment of awards for each such performance period based upon the compensation committee's determination
of the degree of attainment of the performance goals, or assuming that the applicable "target" levels of performance have
been attained or on such other basis determined by the compensation committee.

 In
addition, subject to our Equity Holders Agreement, our Board of Directors may amend our EIP at any time. However, without stockholder
approval, our EIP may not be amended in a manner that would:

 increase
 the number of shares that may be issued under our EIP;

 materially
 modify the requirements for eligibility for participation in our EIP;

 materially
 increase the benefits to participants provided by our EIP; or

 otherwise
 disqualify our EIP for coverage under Rule 16b-3 promulgated under the Exchange Act.

 Awards
previously granted under our EIP may not be impaired or affected by any amendment of our EIP, without the consent of the affected grantees.

 Option
Exercises and Stock Vested

 There
were no options exercised by the executive officers during the years ended December 31, 2023 or 2022.

 Pension
Benefits

 None
of our employees participate in or have account balances in qualified or non-qualified defined benefit plans sponsored by us. Our Compensation
Committee may elect to adopt qualified or non-qualified benefit plans in the future if it determines that doing so is in our company's
best interest.

 Non-qualified
Deferred Compensation

 None
of our employees participate in or have account balances in non-qualified defined contribution plans or other non-qualified deferred
compensation plans maintained by us. Our Compensation Committee may elect to provide our officers and other employees with non-qualified
defined contribution or other non-qualified compensation benefits in the future if it determines that doing so is in our company's
best interest.

 Compensation
of Directors

 The
following table sets forth all compensation paid to our Board members during the year ended December 31, 2023:

 Name

 Fees
 Earned or Paid in Cash ($)

 Stock
 Awards ($)

 Option
 Awards ($)

 Non-Equity
 Incentive Plan Compensation ($)

 Change
 in Pension Value and Nonqualified Deferred Compensation Earnings ($)

 All
 Other Compensation ($)

 Total
 ($)

 Samuel J. Sears
 Jr. (1)

 $
 20,000

 $
 3,500

 -

 -

 -

 -

 $
 23,500

 Niraj Vasisht (1)

 $
 20,000

 $
 3,500

 -

 -

 -

 -

 $
 23,500

 Michelle Yanez (2)

 $
 15,000

 $
 1,750

 -

 -

 -

 -

 $
 16,750

 Michael Jerman (3)

 $
 10,000

 $
 1,034

 -

 -

 -

 -

 $
 11,034

 Ronald E. Osman (4)

 $
 5,000

 $

 -

 -

 -

 -

 $
 5,500

 (1)

 Samuel
 J. Sears Jr. and Niraj Vasisht were appointed to the Board on December 13, 2022.

 (2)

 Michelle
 Yanez was appointed to the Board on December 13, 2022; resigned from the Board on May 24, 2023; appointed to the Board again on October
 13, 2023.

 (3)

 Michael
 Jerman was appointed to the Board on May 24, 2023.

 (4)

 Ronald
 E. Osman was appointed to the Board on August 23, 2023.

 Item
12.
 Security
 Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

 The
following table sets forth, as of the date of this Report, the ownership of our securities by: (i) each of our directors, (ii) all persons
who, to our knowledge, are the beneficial owners of more than 5% of the outstanding shares of common stock, (iii) each of the executive
officers, and (iv) all of our directors and executive officers, as a group. Each person named in this table has sole investment power
and sole voting power with respect to the shares of common stock set forth opposite such person's name, except as otherwise indicated.

 Name
 and address of beneficial owners (1)

 and

 nature
 of

 beneficial

 ownership
 of

 Common
 Stock

 Approximate

 percentage
 of

 outstanding

 common
 stock (2)

 Named Executive
 Officers and Directors

 Francis O'Donnell

 50,000

 *

 James McNulty (3)

 27,347,192

 %

 Samuel J. Sears, Jr. (4)

 1,229,543

 *

 Michelle Yanez

 846,271

 *

 Niraj Vasisht

 50,000

 *

 Michael Jerman

 30,411

 *

 Ronald E. Osman (5)

 23,514,985

 %

 All directors and executive
 officers as a group (7 persons)

 53,068,402

 %

 5% Stockholders

 TPB 2012 LLC (6)

 27,917,250

 %

 MOAB Investments LP (6)

 10.555,000

 %

 Nicholas Virca (7)

 8,727,519

 %

 *

 Less
 than 1%

 (1)

 The
 address of each holder listed below, except as otherwise indicated, is 4905 South West Shore Blvd, Tampa, FL 33611.

 (2)

 Applicable
 percentages are based on 172,023,545 common shares outstanding, and 2,575,646 shares to be issued upon the exercise of vested outstanding
 options, as of the date of this filing. This table is based upon information supplied by officers, directors, and principal stockholders
 and Schedule 13D(s) and Schedule 13G(s) filed with the SEC. Unless indicated in the footnotes to this table and subject to community
 property laws where applicable, we believe that each of the stockholders named in this table has sole voting and investment power
 with respect to the shares indicated as beneficially owned.

 (3)

 Includes
 20,101,057 shares of common stock held by Black Robe Capital LLC, 6,000,000 shares of common stock held by Hopkins Capital Group
 II, LLC, as well as 150,000 shares to be issued upon the exercise of vested stock options. Our Interim Chief Financial Officer, Treasurer
 and Secretary, James A. McNulty, has sole voting and dispositive power over the securities held by Black Robe Capital LLC and Hopkins
 Capital Group II, LLC. Mr. McNulty disclaims beneficial ownership of the shares held by Black Robe Capital LLC and Hopkins Capital
 Group II, LLC in which he does not have a pecuniary interest.

 (4)

 Includes
 150,000 shares to be issued upon the exercise of
 vested stock options.

 (5)

 Includes
 23,489,985 shares of common stock held by Ronald E. Osman Irrevocable Trust III.

 (6)

 Jim
 Donovan is the Manager of TPB 2012 LLC and MOAB Investments LP, with sole voting and dispositive powers over the subject securities.
 Mr. Donovan disclaims beneficial ownership of the shares held by TPB 2012 LLC and MOAB Investments LP. The address of TPB 2012 LLC
 and MOAB Investments LP is 12412 Powerscourt Drive, Suite 35, Saint Louis, MO, 63131.

 (7)

 Nicholas
 Virca is the former Chief Executive Officer and President of the Company. Mr. Virca's address is 449 South 12th Street, Unit
 1705 Tampa, FL 33602.

 Item
13.
 Certain
 Relationships and Related Transactions, and Director Independence.

to the Settlement Agreement, which was effective December 13, 2022, Mayne Pharma surrendered all equity securities in the Company for
cancellation, forgave certain debts owed by the Company and cancelled, converted or terminated all previous agreements between the Company
and Mayne Pharma. Accordingly, as of December 31, 2023 and the date of this report, Mayne Pharma is no longer deemed a related party
of the Company and none of the previously disclosed agreements with Mayne Pharma, which were required to be included in this Item 13,
are in effect as of the date of this report.

 See
"Item 10. Directors, Executive Officers and Corporate Governance " regarding the FEO Employment Agreement and JAM Employment
Agreement.

 All
future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no
less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent directors
who do not have an interest in the transactions and who had access, at our expense, to our independent legal counsel. The Board has determined
that Samuel J. Sears, Jr. Niraj Vasisht, Michelle Yanez and Michael Jerman are independent directors as defined under Regulation S-K.

 Item
14.
 Principal
 Accountant Fees and Services.

 Audit
Fees. The aggregate fees billed by Cherry Bekaert LLP for professional services rendered for the audit of our annual financial statements,
review of the financial information included in our Forms 10-Q for the respective periods and other required filings with the SEC for
the years ended December 31, 2023 and 2022 totaled $68,250 and $44,000, respectively.

 Audit-Related
Fees. There were no aggregate fees billed by Cherry Bekaert LLP for professional services for the years ended December 31, 2023 and
December 31, 2022.

 Tax
Fees. The aggregate fees billed by Cherry Bekaert LLP for professional services rendered for tax compliance, for the years ended
December 31, 2023 and 2022 totaled $13,902 and $4,300, respectively.

 All
Other Fees. None.

 PART
IV

 Item
15.
 Exhibits,
 Financial Statement Schedules.

 The
following exhibits are filed with this Report.

 Exhibit
 No.

 Description

 3.1

 Certificate of Incorporation of the Company, dated July 30, 2013 as filed on 8-K on August 16, 2013

 3.2

 Certificate of Amendment to the Company's Certificate of Incorporation, dated May 19, 2016, as filed with Form 8-K, dated May 26, 2016

 3.3

 Certificate of Amendment to the Company's Certificate of Incorporation, dated July 13, 2015, as filed with Form S-1/A on July 22, 2015

 3.4

 Second Amended and Restated Bylaws of the Company, adopted July 12, 2023, as filed with Form 8-K, dated August 29, 2023

 3.5

 Amended and Restated Certificate of Designation of Series B Preferred Stock of the Company, dated February 1, 2019, filed with Definitive Information Statement, filed on January 8, 2019

 3.6

 Certificate of Amendment to the Company's Certificate of Incorporation, dated August 20, 2019, as filed with Form 8-K dated August 20, 2019

 3.7

 Charter of the Scientific Advisory Board, dated October 13, 2023, filed with Form 8-K dated October 13, 2023

 4.1

 Warrant, dated June 24, 2014 issued to Hedgepath, LLC, as filed with Form 8-K, dated June 30, 2014

 10.1 +

 Master Clinical Services Agreement, dated June 15, 2015, by and between the Company and SciQuus, Inc., as filed with Form 10-Q on August 14, 2015

 10.2

 Stipulation and Agreement of Compromise, Settlement, and Release, dated September 9, 2022, as filed with Form 8-K, dated December 19, 2022

 10.3

 License Agreement by and between the Company and Mayne Pharma, dated December 13, 2022, as filed with Form 8-K, dated December 19, 2022

 10.4

 Employment Agreement by and between the Company and Francis E. O'Donnell, dated December 13, 2022, as filed with Form 8-K, dated December 19, 2022

 10.5

 Employment Agreement by and between the Company and James A. McNulty, dated December 13, 2022, as filed with Form 8-K, dated December 19, 2022

 10.6

 License Agreement by and between the Company and Johns Hopkins University, Dated December 12, 2023 (Portions of this exhibit have been redacted pursuant to a request for confidential treatment.)

 Code of Ethical Conduct, as filed with Form 10-K on February 13, 2015

 23.1*

 Consent of Cherry Bekaert LLP

 31.1*

 Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 31.2*

 Certification of the Interim Chief Financial Officer pursuant to Rule 13a-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 Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 32.2* #

 Certification of the Interim Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 101.ins

 101.sch

 101.cal

 101.def

 101.lab

 101.pre

 XRL Taxonomy Presentation Linkbase Document

 *

 Filed
 herewith

 +

 Confidential
 treatment has been granted for certain portions of this exhibit pursuant to 17 C.F.R. Sections 200.8(b)(4) and 240.24b-2.

 #

 A
 signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
 and furnished to the Securities and Exchange Commission or its staff upon request.

 Item
16.
 Form
 10-K Summary.

 We
have elected not to include a summary pursuant to this Item 16.

 Report of Independent Registered Public Accounting Firm – Cherry Bekaert LLP (PCAOB ID 677)

 Balance Sheets as of December 31, 2023 and 2022

 Statements of Operations for the years ended December 31, 2023 and 2022

 Statements of Stockholders' Equity for the years ended December 31, 2023 and 2022

 Statements of Cash Flows for the years ended December 31, 2023 and 2022

 Notes to Financial Statements

 F- 1

 REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 To
the Board of Directors and Stockholders

 Inhibitor Therapeutics, Inc.

 Opinion
on the Financial Statements

 We
have audited the accompanying balance sheets of Inhibitor Therapeutics, Inc. (the "Company") as of December 31, 2023, and
2022, and the related statements of operations, stockholders' equity, and cash flows for the years 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, 2023, and 2022, and the results of its operations
and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

 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 audits 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 audits,
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
audits 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 audits 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 audits
provide a reasonable basis for our opinion.

 Critical
Audit Matters

 Critical
audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be
communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and
(2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters.

 /s/
 Cherry Bekaert LLP

 We
have served as the Company's auditors since 2013.

 Tampa,
Florida

 March

 F- 2

 BALANCE
SHEETS

 DECEMBER
31, 2023 AND 2022

 December
 31, 2023

 December
 31, 2022

 ASSETS

 Current assets:

 Cash
 and cash equivalents

 $
 8,839,912

 $
 11,951,224

 Prepaid
 expenses and other assets

 109,243

 23,900

 Total
 current assets

 8,949,155

 11,975,124

 Total
 assets

 $
 8,949,155

 11,975,124

 LIABILITIES
 AND STOCKHOLDERS' EQUITY

 Current liabilities:

 Accounts
 payable

 $
 33,731

 145,161

 Notes
 payable

 -

 411,000

 Accrued
 expenses and other liabilities

 631,433

 122,621

 Total
 current liabilities

 665,164

 678,782

 Deferred
 revenue

 3,000,000

 3,000,000

 Total
 liabilities

 3,665,164

 3,678,782

 Commitments and contingencies
 (Note 8)

 -

 -

 Stockholders' equity:

 Series
 A Preferred Stock, $ 0.0001 par value; 500,000 shares authorized; no shares issued and outstanding at December 31, 2023 and December
 31, 2022

 -

 -

 Series
 B Convertible Preferred Stock, $ 0.0001 par value; 7,246,377 shares authorized; no shares issued and outstanding at December 31, 2023
 and December 31, 2022

 -

 -

 Undesignated
 Preferred Stock, $ 0.0001 par value; 2,253,623 shares authorized; no shares issued or outstanding at December 31, 2023 and December
 31, 2022

 -

 -

 Preferred Stock, value

 -

 -

 Common stock, $ 0.0001 par
 value; 500,000,000 shares authorized; 172,023,545 and 171,793,134 shares issued and outstanding at December 31, 2023 and December
 31, 2022

 17,202

 17,179

 Additional
 paid-in capital

 54,046,845

 54,033,084

 Accumulated
 deficit

 ( 48,780,056
)

 ( 45,753,921
)

 Total
 stockholders' equity

 5,283,991

 8,296,342

 Total
 liabilities and stockholders' equity

 $
 8,949,155

 $
 11,975,124

 See
notes to financial statements

 F- 3

 STATEMENTS
OF OPERATIONS

 YEARS

 2023

 2022

 Year
 Ended December 31,

 2023

 2022

 Revenues:

 $
 -

 $
 -

 Expenses:

 Research
 and development

 1,381,066

 6,150

 General
 and administrative

 2,023,913

 651,776

 Total
 expenses

 3,404,979

 657,926

 Loss from
 operations

 ( 3,404,979
)

 ( 657,926
)

 Other income/(expenses):

 Gain on legal settlement

 -

 12,619,492

 Gain on forgiveness of legal
 fees

 -

 223,007

 Interest expense

 -

 ( 23,234
)

 Interest
 income

 378,844

 -

 (Loss) income before income tax expense

)

 12,161,339

 tax expense

 -

 55,109

 Net (loss) income

 $
)

 12,106,230

 Preferred
 stock dividend

 -

 ( 189,042
)

 Net (loss) income applicable to common shareholders

)

 11,917,188

 Basic and diluted (loss) income per share

 $
 ( 0.02
)

 $
 0.03

 Weighted average common
 shares outstanding – basic and diluted

 171,950,108

 366,183,697

 See
notes to financial statements

 F- 4

 STATEMENTS
OF STOCKHOLDERS' EQUITY

 YEARS

 Shares

 Shares

 Capital

 Deficit

 (Deficit)

 Preferred

 Stock–Series
 B

 Common
 Stock

 Additional

 Paid-In

 Accumulated

 Total

 Stockholders'
 Equity

 Shares

 Shares

 Capital

 Deficit

 (Deficit)

 Balances, January
 1, 2022

 5,797,102

 $
 3,960,866

 376,858,323

 $
 37,686

 $
 50,051,711

 $
 ( 57,671,109
)

 $
 ( 3,620,846
)

 Preferred stock dividends

 —

 —

 —

 —

 —

 ( 189,042
)

 ( 189,042
)

 Cancellation of preferred
 and common stock

 ( 5,797,102
)

 ( 3,960,866
)

 ( 205,065,189
)

 ( 20,507
)

 3,981,373

 —

 Net
 income

 —

 —

 —

 —

 —

 12,106,230

 12,106,230

 Balances, December 31, 2022

 —

 $
 —

 171,793,134

 $
 17,179

 $
 54,033,084

 $
 ( 45,753,921
)

 $
 8,296,342

 Balances

 —

 $
 —

 171,793,134

 $
 17,179

 $
 54,033,084

 $
 ( 45,753,921
)

 $
 8,296,342

 Issuance of common stock under
 equity incentive plan

 —

 —

 230,411

 13,761

 —

 13,784

 Net
 loss

)

)

 Net
 income (loss)

)

)

 Balances,
 December 31, 2023

 —

 $
 —

 172,023,545

 $
 17,202

 $
 54,046,845

 $
 ( 48,780,056
)

 $
 5,283,991

 Balances

 —

 $
 —

 172,023,545

 $
 17,202

 $
 54,046,845

 $
 ( 48,780,056
)

 $
 5,283,991

 See
notes to financial statements

 F- 5

 STATEMENTS
OF CASH FLOWS

 YEARS

 2023

 2022

 Year
 Ended December 31,

 2023

 2022

 OPERATING
 ACTIVITIES

 Net (loss) income

 $
)

 $
 12,106,230

 Adjustments to reconcile net (loss) income to net cash flows (used
in) provided by operating activities

 Stock
 based compensation

 13,784

 -

 Gain on
 legal settlement

 -

 ( 330,830
)

 Gain on
 forgiveness of legal fees

 -

 ( 176,889
)

 Changes in assets and liabilities:

 Prepaid
 expense and other assets

 ( 85,343
)

 4,258

 Accounts
 payable and other current liabilities

 397,382

 137,829

 Net
 cash (used in) provided by operating activities

 ( 2,700,312
)

 11,740,598

 FINANCING
 ACTIVITIES

 Proceeds from notes payable

 -

 180,000

 Payments
 made on notes payable

 ( 411,000
)

 -

 Net
 cash (used in) provided by financing activities

 ( 411,000
)

 180,000

 Net (decrease) increase in
 cash and cash equivalents

 ( 3,111,312
)

 11,920,598

 Cash
 and cash equivalents at beginning of year

 11,951,224

 30,626

 Cash
 and cash equivalents at end of year

 $
 8,839,912

 $
 11,951,224

 Supplemental disclosure of
 non-cash financing activities:

 Cancellation
 of Mayne equity

 $
 -

 $
 3,981,373

 Accrued,
 but unpaid dividends

 $
 -

 $
 189,042

 Supplemental disclosures of
 cash flow information:

 Cash paid
 for taxes

 $
 53,088

 $
 -

 See
notes to financial statements

 F- 6

 NOTES

 YEARS

 1. Corporate Overview

 Overview

 The
accompanying audited financial statements of Inhibitor Therapeutics, Inc., a Delaware corporation (the "Company", "INTI",
"we", "us" or similar terminology) have been prepared by the Company as a going concern, and in accordance with
accounting principles generally accepted in the United States of America ("GAAP"). As used herein, the term "common
stock" means the Company's common stock, $ 0.0001 par value per share.

 Nature
of the Business

 The
Company is a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics
based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with
certain cancers and certain non-cancerous proliferation disorders. We also have explored and expect to continue to explore acquiring
or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other
diseases based on repurposing active ingredients of already approved drugs.

 Our
current primary focus is on the development of therapies initially for basal cell carcinoma ("BCC"), prostate and lung cancers
in the United States utilizing itraconazole, a drug currently approved by the FDA to treat fungal infections, and which has an extensive
history of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of
cancer patients using itraconazole. In particular, on December 12, 2023, the Company entered into an Exclusive License Agreement (the
"Agreement") with Johns Hopkins University ("JHU"). Pursuant to the Agreement, JHU granted to the Company the
exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled "New Angiogenesis Inhibitors" (the "Patent").
The Patent relates to the treatment of prostate cancer, BCC including basal cell carcinoma nevus syndrome ("BCCNS"), and
lung cancer.

 2. Liquidity and Management's
Plans

 The Company is presently focused on its
business plan of developing and ultimately commercializing innovative therapeutics based on already approved active pharmaceuticals that
have patent-protected methods of use and/or methods of delivery. The Company expects to progress with the FDA in 2024 to reach a conclusion
on whether any additional clinical trials are required before submitting a New Drug Application (NDA). The current cash on hand, approximately
$ 8.8 million on December 31, 2023, is sufficient to continue to execute the Company's business plan as currently anticipated, without
another required clinical trial. Based on the current operational plan and budget, the Company expects to have sufficient cash to manage
its business and continue to pursue clinical trials and acquire other drug development opportunities, as needed. As capital requirements
for additional opportunities are determined, the Company will consider raising additional capital in the public market.

 3. Summary of Significant Accounting Policies

 Recent
Accounting Pronouncements

 Management
has considered all other recent accounting pronouncements that are issued, but not effective, and it does not believe that they will
have a significant impact on the Company's results of operations or financial position.

 Estimates

 The
preparation of financial statements 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 financial statements and the reported amounts
of revenues and expenses during the period. Actual results could differ from those estimates.

 Revenue
Recognition

 The
Company currently has no ongoing source of revenue. Miscellaneous income, including interest, is recognized when earned by the Company.
Deferred revenue represents cash received for royalties in advance of being earned. Such payments are reflected as deferred revenue until
recognized under the Company's revenue recognition policy. Deferred revenue would be classified as current if management believes
the Company will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. Deferred revenue
will be recognized when the product is sold and the royalty is earned. Since all deferred revenue is related to the BCCNS product, which
is yet to be approved by FDA, the Company has determined that 100 % of the advances of the royalty received from Mayne Pharma should be
classified as non-current. As of December 31, 2023 and 2022, deferred revenue consisted of $ 3.0 million of royalties advanced by Mayne
Pharma under the Third Amended Supply and License Agreement ("SLA").

 F- 7

 NOTES

 YEARS

 3.
 Summary
 of Significant Accounting Policies (continued)

 Legal
Settlement

 Gain
on legal settlement includes a legal settlement awarded to and received by the Company in accordance with a Settlement Agreement, along
with various other items, including legal costs incurred relating to the litigation and forgiveness of certain balances due to the Defendants.

 Forgiveness
of Legal Fees

 Gain
on forgiveness of legal fees includes the forgiveness of legal fees previously incurred and owed to external legal counsel.

 Cash
and Cash Equivalents

 The
Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents.
At times, the Company may maintain cash balances in bank accounts in excess of Federal Deposit Insurance Corporation insured amounts.
The Company continues to monitor the third-party depository institutions that hold the Company's cash and limits its cash deposits
to financial institutions with high credit standing.

 Research
and Development Expenses

 Research
and development ("R&D") costs are expensed in the period in which they are incurred and include salaries, benefits and
other related costs to support the Company's R&D operations, amounts paid to third parties who conduct research and development
activities on behalf of the Company, as well as the costs of discovery research, preclinical and clinical development, drug formulation
and licensing payments. Upfront and advanced licensing payments for future use in R&D activities are recorded as prepaid expenses
and are expensed as the related services are performed.

 General
and Administrative Expenses

 General
and administrative ("G&A") expenses are expensed in the period in which they are incurred and include operating expenses
not classified as R&D expenses, such as salaries, benefits, insurance, board of directors' fees, travel costs, as well as fees
for professional services related to accounting, tax and legal matters. Penalties and interest assessed as a result of unresolved tax
liabilities are also classified as G&A expenses.

 Stock-Based
Compensation

 The
Company accounts for stock-based awards to employees and non-employees using Financial Accounting Standards Board ("FASB")
Accounting Standards Codification ("ASC") Topic 718 – Accounting for Share-Based Payments, which provides for the use
of the fair value-based method to determine compensation for all arrangements where shares of stock or equity instruments are issued
for compensation. Fair values of restricted stock units issued are determined by the Company based predominantly on the trading price
of the common stock on the date of grant. Fair value of each common stock option is estimated on the date of grant using the Black-Scholes
valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected
volatility is based on historical volatility of a peer group's common stock and other factors estimated over the expected term
of the options. The expected term of the options granted is derived using the "simplified method" which computes the expected
term as the average of the weighted-average vesting term and the contract term. The risk-free rate is based on the U.S. Treasury yield.
During the year ended December 31, 2023, we granted 230,411 shares of restricted common stock that are restricted as to trading for a
period of one year from the date of grant. No stock-based awards were issued during the year ended December 31, 2022.

Taxes

 Deferred
tax assets and liabilities are recognized for future tax consequences attributed to differences between the financial statement carrying
amounts of existing assets and liabilities and their respective tax bases and are measured using enacted tax rates that are expected
to apply to the differences in the periods that they are expected to reverse. Management has evaluated the guidance relating to accounting
for uncertainty in income taxes and has determined that the Company had no uncertain income tax positions that could have a significant
effect on the financial statements for the years ended December 31, 2023 or 2022.

 Effective January 1, 2022, a provision of the Tax Cuts and Jobs Act (TCJA) took effect creating a significant change
to the treatment of research and experimental expenditures under Section 174 of the Internal Revenue Code (Sec. 174 expenses). Historically,
businesses have had the option of deducting Sec. 174 expenses in the year incurred or capitalizing and amortizing the costs over five
years. The new TCJA provision, however, eliminates this option and will require Sec. 174 expenses associated with research conducted in
the United States to be capitalized and amortized over a five-year period.

 F- 8

 NOTES

 YEARS

 4. Notes Payable

 On
December 12, 2020, the Company and Mayne Pharma entered into a letter agreement for a term debt facility (the "Loan Agreement")
pursuant to which Mayne Pharma provided an aggregate $ 231,000 credit facility to the Company (the "Facility"). The Facility
would bear interest at the rate equal to the interest rate tied to the US Bank Prime Rate plus 5.00% (the "Interest Rate")
with a maturity date of twenty-four ( 24) months from the date of the first drawdown (the "Maturity Date"). The Interest Rate
would be adjusted for each drawdown on the Facility in accordance with changes in the monthly average of the US Bank Prime Rate, as reported
in the Federal Reserve Statistical Release H.15 for the month preceding the week in which the Company shall make a drawdown against the
Facility. Proceeds drawn from the Facility were used by the Company for general working capital and corporate purposes.

 The
Facility was available to the Company as follows: (i) $ 81,000 may be drawn upon request at any time in the first annual quarter of the
Facility starting December 14, 2020 and (ii) so long as there is no event of default and Mayne Pharma does not give notice in its discretion
30 days before the start of a quarter that it is discontinuing the funding, $ 75,000 may be drawn in the second and third annual quarters
of the Facility, respectively. Any drawdown by the Company must equal or exceed $ 25,000. The Company had one twelve-month repayment free
advance period from its first drawdown on the Facility. Each other advance on the Facility would be amortized over twelve equal monthly
payments of principal plus interest. No premium was payable in the event that the Company pays all principal, interest and other outstanding
amounts due to Mayne Pharma prior to the Maturity Date.

 The
Facility was unsecured, contained no financial covenants, required no guarantees and was not accompanied by any equity component. The
Loan Agreement included certain limited representations and warranties and negative covenants of the Company.

 The
Loan Agreement was negotiated and approved on behalf of the Company by a special committee of disinterested, independent members of the
Company's Board of Directors which was formed on November 17, 2020 for such purpose. The special Board committee consisted of W.
Mark Watson, R. Dana Ono and Debra Peattie, who were each disinterested with respect to Mayne Pharma. The balance at December 31, 2021
was $ 231,000.

 During
2022, the Company executed several agreements with Mayne Pharma to amend the Loan Agreement and the Facility (the "Loan Amendments").
Under the terms of the Loan Amendments: (i) the amount of the Facility was increased several times, ultimately to $ 411,00 0, (ii) the
maturity date of the Facility was extended several times and the outstanding balance was ultimately agreed to be repaid per the settlement
relating to the Company's litigation proceedings described in Note 8. Except as modified by the Loan Amendment, the terms and conditions
of the Loan Agreement and the Facility remained in full force and effect. The proceeds of the expanded Facility were used by the Company
for general working capital purposes, including the payment of a portion of previously deferred employee compensation to allow the Company
to continue to operate until the proceeds from the legal settlement were received. Proceeds of $ 180,000 related to this letter agreement
were received during the year ended December 31, 2022. The balance outstanding at December 31, 2022 was $ 411,000 and was repaid in February
2023.

 5. Income Taxes

 The
components of the income tax expense for the years ended December 31, 2023 and 2022 were as follows:

of Components of Income Tax Expense

 2023

 2022

 Years
 Ended December 31,

 2023

 2022

 Current:

 Federal

 $
 -

 $
 22,850

 State

 -

 32,259

 Total
 current expense

 -

 55,109

 Deferred:

 Federal

 -

 -

 State

 -

 -

 Total
 deferred expense

 -

 -

 tax expense

 $
 -

 $
 55,109

 F- 9

 NOTES

 YEARS

 5.
 Taxes (continued)

 The
difference between expected income tax expense (benefit) and income tax expense (benefit) recorded in the financial statements is explained
below:

of Expected Income Tax Expense (Benefit)

 2023

 2022

 Years
 Ended December 31,

 2023

 2022

 Income taxes (benefit)
 expense computed at statutory rate

 $
 ( 635,488
)

 $
 2,514,182

 State income tax (benefit)
 expense, net

 ( 131,486
)

 520,196

 Other

 45,096

 ( 70,951
)

 Change
 in valuation allowance

 721,878

 ( 2,908,318
)

 Total

 $
 —

 $
 55,109

 The
significant components of deferred income tax assets and liabilities consist of the following:

of Significant Components of Deferred Income Tax Assets and Liabilities

 Deferred
 tax assets (liabilities)

 2023

 2022

 December
 31,

 Deferred
 tax assets (liabilities)

 2023

 2022

 In-process research
 and development

 $
 742,574

 $
 742,574

 Net operating loss carry forward

 3,516,913

 3,870,413

 Capitalized research expense

 315,028

 —

 Deferred income

 760,350

 —

 R&D credit

 78,336

 78,336

 Share-based compensation

 34,231

 34,231

 Other

 6,061

 6,061

 Total deferred tax assets

 5,453,493

 4,731,615

 Less:
 valuation allowance

 ( 5,453,493
)

 ( 4,731,615
)

 Total

 $
 —

 $
 —

 In
accordance with GAAP, it is required that a deferred tax asset be reduced by a valuation allowance if, based on the weight of available
evidence it is more likely than not (a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized.
At December 31, 2023 and 2022, the Company recorded a 100 % valuation allowance against its deferred tax assets as it has determined such
amounts will not be currently realizable.

 The
Company has historically generated federal and state net operating loss ("NOLs"). Under Section 382 and 383 of the Internal
Revenue Code, if an ownership change occurs with respect to a "loss corporation", as defined, there are annual limitations
on the amount of the NOLs and other deductions which are available to the Company. Although the NOLs are available to be used to offset
the taxable income generated from the Settlement Agreement, otherwise the NOLs incurred prior to December 13, 2022 are subject to this
limitation. As such, the use of these NOLs to offset taxable income was limited to approximately $ 37,000
 in 2022 subsequent to the Effective Date of the
Settlement Agreement and approximately $ 0.7
 million per year in 2023 and future periods.
As of December 31, 2023 and 2022, the Company's federal and state NOLs are approximately $ 14
 million and $ 15
 million, respectively.

 Penalties
and interest incurred by the Company as a result of unresolved tax liabilities during the year ended December 31, 2023 totaled approximately
$ 17,000. These costs are included in General and administrative expenses within the Statement of Operations and are accrued within Accrued
expenses and other liabilities on the balance sheet as of December 31, 2023.

 The Company follows the provisions of ASC 740-10 "Uncertainty in Income Taxes" wherein certain recognition
thresholds must be met before a tax position is recognized in the financial statements. An entity may only recognize or continue to recognize
tax positions that meet a "more-likely-than-not" threshold. As of December 31, 2023 and 2022, the Company does not believe
it has any uncertain tax positions that would require either recognition or disclosure in the accompanying financial statements.

 6. Stockholders' Equity

 Employee
Stock Plans

 A
2009 Stock Incentive Plan was adopted by the Board of Directors and approved by the shareholders of CBI, the Company's predecessor
company. There are no options outstanding under this plan. On July 18, 2014, the Equity Incentive Plan ("EIP") was adopted
by the Company's Board of Directors. On September 30, 2014, the EIP was approved by the majority of stockholders. The 2014 EIP
initially authorized the issuance of up to 32,583,475 shares of the Company's common stock. An additional 11 million shares were
added to the 2014 EIP for a total of 43,583,475 shares pursuant to the agreement entered into by the Company and Mayne Pharma in December
2018.

 F- 10

 NOTES

 YEARS

 6.
 Stockholders'
 Equity (continued)

to the Settlement Agreement, Mayne Pharma agreed to surrender for cancellation 205,065,189 shares of common stock and 5,797,102 shares
of preferred stock, which were convertible to 17,391,306 shares of common stock. Additionally, 4,347,827 warrants held by Mayne Pharma
and 10,773,815 options held by former officers and directors named as Individual Defendants were cancelled pursuant to the Settlement
Agreement.

 Stock
option activity for the years ended December 31, 2023 and 2022 is as follows:

of Stock Option Activity

 of Shares

 Weighted
 Average

 Price Per

 Share

 Aggregate

 Intrinsic

 Value

 Outstanding at
 December 31, 2021

 13,349,461

 $
 0.10

 $
 1,072,144

 Granted

 -

 -

 -

 Forfeited

 ( 10,773,815
)

 Outstanding at December 31,
 2022

 2,575,646

 $
 0.09

 $
 111,774

 Granted

 -

 -

 -

 Forfeited

 -

 Outstanding at December 31,
 2023

 2,575,646

 $
 0.09

 $
 93,633

 Options
outstanding (all are exercisable) at December 31, 2023 are as follows:

of Stock Options Outstanding

 Range
 of
 Prices

 Outstanding

 Weighted
 Average
Remaining
Contractual Life
(Years)

 Weighted
 Average
 Price

 Aggregate
 Intrinsic
 Value

 $ 0.03 - $ 0.10

 2,015,646

 6.5

 $
 0.04

 $
 93,633

 $ 0.11
 - $ 0.30

 560,000

 3.3

 $
 0.25

 $
 -

 2,575,646

 $
 93,633

 There
were no options issued during the years ended December 31, 2023 and 2022. As of December 31, 2023, there was no unamortized stock-based
compensation.

 Incentive
awards may be in the form of stock options, restricted stock, restricted stock units and performance and other awards. In the case of
incentive stock options, the exercise price will not be less than 100 % of the fair market value of shares covered at the time of the
grant, or 110 % for incentive stock options granted to persons who own more than 10 % of the Company's voting stock. Options granted
will generally vest over a three-year period from the date of grant and will be exercisable for ten years, except that the term may not
exceed five years for incentive stock options granted to persons who own more than 10 % of the Company's outstanding common stock.
Stock-based compensation expense is determined based on the fair value of the stock-based awards and recognized over the vesting period.
Fair values of restricted stock units issued are determined by the Company based predominantly on the trading price of the common stock
on the date of grant.

 During
the year ended December 31, 2023, the Company granted 230,411 restricted common shares with an aggregate grant date fair value of approximately
$ 0.01 million to the members of our Board of Directors under the equity incentive plan. The common shares are fully vested upon issuance
but are restricted to trading for a period of one year from the date of grant. There was no stock-based compensation for the year ended
December 31, 2022.

 F- 11

 NOTES

 YEARS

 7. Related Party Transactions

 The
Company had significant contractual agreements with Mayne Pharma, a majority stockholder prior to the Settlement Agreement discussed
in Note 8. There were amounts due to Mayne Pharma at December 31, 2022 as discussed in Note 4, which were repaid in February 2023. Following
the resolution of the litigation in December 2022 and the resulting Settlement Agreement that resulted in Mayne Pharma surrendering all
equity securities in the Company for cancellation, Mayne Pharma is no longer considered a related party of the Company.

 8. Commitments and Contingencies

 Exclusive
License Agreement with Johns Hopkins University

 On
December 12, 2023, the Company entered into an Exclusive License Agreement (the "Agreement") with Johns Hopkins University
("JHU"). Pursuant to the Agreement, JHU granted to the Company the exclusive worldwide patent rights to a Granted US Patent,
No 8,980,930 entitled "New Angiogenesis Inhibitors" (the "Patent"). The Patent relates to the treatment of prostate
cancer, basal cell carcinoma including basal cell carcinoma nevus syndrome, and lung cancer.

to the Agreement: (i) the Company has received an exclusive worldwide license to the Patent; (ii) the Company paid JHU an upfront license
fee in December 2023, (iii) the Company shall be required to make certain Minimum Annual Royalty ("MAR") payments to JHU
no later than January 1st of each calendar year in accordance with an agreed upon schedule, (iv) the Company shall be required to pay
to JHU a royalty on cumulative net sales, with an additional supplement due where a licensed product is given exclusivity in the U.S.
by patent rights, (v) if the Company enters into any sublicense they will pay to JHU a certain percentage of all consideration received
from sublicensee but excluding (i) any consideration received by Licensee for Royalties on Sublicensee Sales (Royalties on Sales by Sublicensees
will be treated as if Licensee made the Sale), and (ii) any payment of Past Patent Costs or Patent Costs made by Sublicensee to License),
(vi) should the Company receive compensation in the form of a voucher, the Company will pay a certain percentage of the sale to JHU and
(vii) the Company shall be required to pay to JHU certain development-related milestone payments upon the Company meeting each of a series
of agreed upon milestones. The Agreement contains other customary terms and conditions.

 JHU
has the right to terminate the Agreement upon the occurrence of certain events, including delinquency in payments, failure to timely
reach milestones, noncompliance with audit or insurance obligations, or the Company entering into voluntary bankruptcy or insolvency.
The Company may terminate the Agreement without cause upon 90 days advance written notice.

 In
compliance with the agreement, the Company paid in December 2023 (i) the upfront license fee of $ 40,000, which has been recorded as a
prepaid expense and will be expensed over the term of the Agreement and (ii) the first MAR of $ 10,000. The remaining MAR payments required
to be paid by the Company no later than January 1 st of each calendar year are as follows:

 By
January 1, 2025: $ 10,000

 By
January 1, 2026: $ 15,000

 By
January 1, 2027 and every year thereafter until the first commercial sale of an associated licensed product: $ 50,000

 Legal
Proceedings

 The
Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. Except as discussed
below, the Company is not the subject of any pending legal proceedings.

 On
September 15, 2022, Hedgepath, LLC ("HPLLC"), a significant minority stockholder of the Company at the time, filed a civil
action in the Delaware Court of Chancery (the "Court") captioned Hedgepath, LLC v. Magrab, et al., C.A. No. 2019-0529-JTL
(the "Action") against certain of the Company's current and former directors, and its President and Chief Executive
Officer (the "Individual Defendants"), as well as the Company's majority stockholder, Mayne Pharma Ventures Pty Ltd.
("Mayne Pharma", and collectively with the Individual Defendants, the "Defendants"). The Company was named as
a nominal defendant given the derivative nature of the claims. On December 3, 2019, HPLLC filed its Verified Amended and Supplemental
Complaint (the "Complaint"). The Complaint asserts various claims, either directly on behalf of HPLLC or derivatively on
behalf of the Company, for alleged breaches of fiduciary duty, violation of Delaware statute, waste, fraudulent misrepresentation, declaratory
judgment, and dilution of stockholder equity arising out of transactions previously entered into between the Company and Mayne Pharma
and Mayne Pharma's relationship with the Company generally. The Complaint seeks unspecified damages and other relief. Additionally,
on March 23, 2020, a Stockholder Class Action Complaint was filed in the Court by Company stockholder and purported class representative
Samuel P. Sears purportedly on behalf of a class of certain holders of the Company's common stock. That lawsuit, captioned Sears
v. Magrab et al., C.A. No. 2020-0215-JTL (the "Putative Class Action"), asserts claims against the same Defendants (with
the exception of the Company), and the facts underlying the claims largely mirror those alleged in the Action. On December 10, 2020,
the Court entered a stipulated Order coordinating the Action and the Putative Class Action (together, the "Coordinated Actions").

 F- 12

 NOTES

 YEARS

 On
September 9, 2022, HPLLC, Sears, the Company, the Individual Defendants and Mayne Pharma entered into a Stipulation and Agreement of
Compromise, Settlement, and Release, dated and filed with the Court (together with the exhibits thereto, the "Settlement Agreement"),
which the Court approved, and the Settlement Agreement went into effect on December 13, 2022 (the "Effective Date").

to the Settlement Agreement, (i) the Defendants will cause $ 14,250,000 in cash (to be funded via Mayne Pharma's director and officer
insurance) to be paid to the Company (the "Cash Consideration"); (ii) Mayne Pharma will surrender all equity securities in
the Company for cancellation, and will forgive certain debts it is owed by the Company; (iii) stock options and warrants held by the
Individual Defendants will be cancelled; (iv) certain intellectual property licenses to and from the Company, on one hand, and Mayne
Pharma, on the other, will be converted or terminated, with only certain obligations remaining in place; (v) each of the Individual Defendants
will retire from their positions with the Company, including as members of the Company's Board of Directors and management; (vi)
the Third Amended and Restated Supply and License Agreement, dated December 17, 2018, between the Company and Mayne will be cancelled,
with the Company retaining a royalty on future net sales of SUBA-Itraconazole BCCNS in the United States subject to certain contingent
payment obligations; and (vii) various releases will be exchanged among the parties to the Coordinated Actions. After the Effective Date,
Mayne Pharma has also agreed it will remain amenable to discussing with the Company, in good faith, the potential licensing and/or sub-
licensing of the JHU Patents (as defined in the Settlement Agreement), for a commercially reasonable licensing fee, to the extent the
Company seeks to engage in such discussions and that it will not take the position that the Company or persons affiliated with the Company,
including Dr. Francis E. O'Donnell, Jr., are prohibited from developing or commercializing Non-SUBA Formulations of Itraconazole
for any cancer or non-cancer indications. Nor shall Mayne Pharma take any action intended to restrict or limit the Company's ability
or efforts to develop or commercialize Non- SUBA Formulations of Itraconazole for any cancer or non-cancer indications. Upon approval
by the Court, the Coordinate Actions were deemed fully resolved and all asserted claims were dismissed with prejudice on the Effective
Date.

 The
Cash Consideration received by the Company pursuant to the Settlement Agreement in the amount of $ 14.25 million is reflected as a Gain
on legal settlement within the Statement of Operations along with various other items stipulated within the Settlement Agreement, including
(i) legal costs incurred by the Company relating to the litigations of $ 2.0 million, (ii) forgiveness of certain balances due to Mayne
Pharma of approximately $ 0.3 million and (iii) various compensation-related items owed to the Individual Defendants of approximately
$ 0.04 million. As discussed in Note 5, the potential income taxes generated from the taxable income resulting from this settlement is
mitigated substantially from the utilization of federal and state NOLs, resulting in a cash tax liability for 2022 of approximately $ 55,000.

 On
December 10, 2022, and in furtherance of the transactions contemplated by the Settlement Agreement, W. Mark Watson, Stefan J. Cross,
Dr. R. Dana Ono, and Robert D. Martin (collectively, the "Resigning Directors") gave notice of the Company of their resignation
from the Board to be effective on December 13, 2022. The purpose of resignation of the Resigning Directors is in relation to the Settlement
Agreement and not based on any disagreement with the Company on any matter relating to the Company's operations, policies, or practices.
Pursuant to the Settlement Agreement, the stock options and warrants held by the Resigning Directors were cancelled.

 On
December 10, 2022, and in furtherance of the transactions contemplated by the Settlement Agreement, Nicholas J. Virca and Garrison J.
Hasara (collectively, the "Resigning Officers") gave notice of the Company of their resignation from their officer positions
to be effective on December 13, 2022. The purpose of resignation of the Resigning Officers is in relation to the Settlement Agreement
and not based on any disagreement with the Company on any matter relating to the Company's operations, policies, or practices.
Pursuant to the Settlement Agreement, the stock options and warrants held by the Resigning Officers were cancelled.

 Office Lease

 The company leases office space
under a non-cancelable operating lease with an expiration date of May 31, 2024. Due to the short-term nature of the agreement, the Company
has elected not to apply the recognition requirements of ASC Topic 842 - Leases for
this lease agreement in accordance with ASC 842-20-25-2. The rent expense associated with the lease agreement is recognized on a straight-line
basis over the lease term within General and administrative expenses within the Statement of Operations. Rent expense for the years ended
December 31, 2023 and 2022 totaled approximately $ 25,000
 and $ 0,
respectively.

 9.
 Subsequent Events

 In
February 2024, the Company approved a proposal with Avior Bio, Inc. ("Avior") for the creation of a new patentable formulation
of itraconazole. Avior will develop, manufacture and release the formulation and assist with the regulatory process. The Company expects
to pay fees of approximately $ 0.3 million for these services, all of which are expected to be incurred in 2024. The Chief Executive Officer
of Avior is a member of the Company's Board of Directors, and as a result Avior is deemed to be a related party of the Company.

 F- 13

 SIGNATURES

 In
accordance with Section 13 or 15(d) of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.

 Date:
 March 29, 2024

 By:

 /S/
 Francis E. O'Donnell

 Name:

 E. O'Donnell

 Title:

 Chief
 Executive Officer

 (Principal
 Executive Officer)

 By:

 /s/
 James A. McNulty

 Name:

 James
 A. McNulty

 Title:

 Interim
 Chief Financial Officer, Treasurer and Secretary

 (Principal
 Accounting Officer)

 In
accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.

 Person

 Capacity

 Date

 /S/
 Francis E. O'Donnell

 Chairman
 and Director

 March

 E. O'Donnell

 /S/
 Samuel J. Sears

 March

 Samuel
 J. Sears

 /S/
 Niraj Vasisht

 March

 Niraj
 Vasisht

 /S/
 Michelle Yanez

 March

 Michelle
 Yanez

 /S/
 Michael Jerman

 March

 Michael
 Jerman

 /S/
 Ronald E. Osman

 March

 Ronald
 E. Osman