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 UNITED
STATES

 SECURITIES
AND EXCHANGE COMMISSION

 Washington,
D.C. 20549

 FORM

 (Mark
One)

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

 For
the fiscal year ended December 31, 2024

 OR

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

Pharma Inc.

 (Exact
name of registrant as specified in its charter)

 Delaware

 001-39318

 46-3973463

 (State
 or Other Jurisdiction

 of
 Incorporation)

 (Commission

 File
 Number)

 (IRS
 Employer

 Identification
 No.)

 1920
 McKinney Avenue, 7th Floor

 Dallas,
 Texas

 75201

 (Address
 of Principal Executive Offices)

 (Zip
 Code)

 (972) 277-1136

 ( Registrant's
telephone number, including area code)

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

 Title
 of each class

 Trading
 Symbol

 Name
 of each exchange on which registered

 Common
 Stock, $0.0001 par value

 LTRN

 The
 Nasdaq Stock Market

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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes No

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

 Large
 accelerated filer

 Accelerated
 filer

 Non-accelerated
 filer

 Smaller
 reporting company

 Emerging
 growth company

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

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 required a recovery analysis of incentive-based compensation
received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b).

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

 State
the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which
the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant's
most recently completed second fiscal quarter: $ 44,285,965.

 As
of March 17, 2025, the registrant had 10,784,725 shares of common stock, $ 0.0001 par value per share outstanding.

 DOCUMENTS
INCORPORATED BY REFERENCE

 Portions
of the registrant's definitive proxy statement for the registrant's 2025 Annual Meeting of Stockholders to be filed pursuant
to Regulation 14A within 120 days of the registrant's year ended December 31, 2024 are incorporated herein by reference into Part
III of this Annual Report on Form 10-K.

 Table
of Contents

 Page

 Forward Looking Statements

 ii

 PART I.

 Item
 1.

 Business

 Item
 1A.

 Risk Factors

 Item
 1B.

 Unresolved Staff Comments.

 Item
 1C.

 Cybersecurity

 Item
 2.

 Properties.

 Item
 3.

 Legal Proceedings.

 Item
 4.

 Mine Safety Disclosures.

 Item
 5.

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

 Item
 6.

 Reserved.

 Item
 7.

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

 Item
 7A.

 Quantitative and Qualitative Disclosures About Market Risk.

 Item
 8.

 Financial Statements and Supplementary Data.

 Item
 9.

 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

 Item
 9A.

 Controls and Procedures.

 Item
 9B.

 Other Information.

 Item
 9C.

 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

 Item
 10.

 Directors, Executive Officers and Corporate Governance.

 Item
 11.

 Executive Compensation.

 Item
 12.

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

 Item
 13.

 Certain Relationships and Related Transactions, and Director Independence.

 Item
 14.

 Principal Accountant Fees and Services.

 Item
 15.

 Exhibit and Financial Statement Schedules.

 Item
 16.

 Form 10–K Summary.

 i

 SPECIAL
NOTE CONCERNING FORWARD-LOOKING STATEMENTS

 This
Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking
statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities
Exchange Act of 1934, as amended, and other federal securities laws. All statements, other than statements of historical fact, contained
in this Annual Report on Form 10-K, including statements regarding our strategy, future preclinical study activities, future clinical
trial activities, future research activities, future financial position, projected costs, prospects, plans and objectives of management,
are forward-looking statements. The words "anticipate," "believe," "contemplate," "could,"
"estimate," "expect," "intend," "seek," "may," "might," "plan,"
"potential," "predict," "project," "target," "model," "objective,"
"aim," "upcoming," "should," 'will," "would," or the negative of these words
or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain
these words. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject
to risks and uncertainties.

 The
forward-looking statements in this Annual Report on Form 10-K include, among other things, statements relating to:

 the
 potential advantages of our RADR platform in identifying drug candidates and patient populations that are likely
 to respond to a drug candidate;

 our
 strategic plans to advance the development of any of our drug candidates;

 our
 strategic plans to expand the number of data points that our RADR platform can access and analyze;

 our
 research and development efforts of our internal drug discovery and development programs and antibody drug conjugate (ADC) development
 program and the utilization of our RADR platform to streamline the drug development process;

 the
 initiation, timing, progress, and results of our preclinical studies or clinical trials for any of our drug candidates;

 our
 intention to leverage artificial intelligence, machine learning and biomarker data to streamline the drug development process and
 to identify patient populations that would likely respond to a drug candidate;

 our
 plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves
 or in collaboration with others;

 our
 expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our existing cash and
 cash equivalents;

 our
 ability to secure sufficient funding and alternative sources of funding to support our existing and proposed preclinical studies
 and clinical trials;

 our
 estimates regarding the potential market opportunity for our drug candidates we or any of our collaborators may in the future develop;

 our
 anticipated growth strategies and our ability to manage the expansion of our business operations effectively;

 our
 expectations related to future expenses and expenditures;

 our
 ability to keep up with rapidly changing technologies and evolving industry standards, including our ability to achieve technological
 advances;

 our
 ability to source our needs for skilled labor in the fields of artificial intelligence, genomics, biology, oncology and drug development;
 and

 the
 impact of government laws and regulations on the development and commercialization of our drug candidates and ADC development program.

 ii

 We
may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations
disclosed in the forward-looking statements we make. Factors that may cause actual results or events to differ materially from current
plans, intentions, and expectations include, among other things:

 We
 have a limited operating history and have never generated any revenues other than from a prior research grant, which may make it
 difficult to evaluate the success of our business to date and to assess our future viability;

 We
 have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses
 for the foreseeable future and may never achieve or maintain profitability;

 We
 will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce
 or eliminate our drug development programs or commercialization efforts;

 Our
 RADR platform may fail to help us discover and develop additional potential drug candidates;

 We
 have limited experience in drug discovery and drug development and may not receive regulatory approval to market our drug candidates;

 Even
 if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing one or
 more of our drug candidates; and

 Those
 other risk factors listed under Part I, Item 1A. "Risk Factors," Part II, Item 7. "Management's Discussion
 and Analysis of Financial Condition and Results of Operations" and elsewhere in this Annual Report on Form 10-K.

 These
factors could cause actual results or events to differ materially from the forward-statements that we make. Furthermore, we operate in
a competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to
predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Annual Report on Form
10-K.

 You
should read this Annual Report on Form 10-K and the documents that we file with the Securities and Exchange Commission, or the SEC, with
the understanding that our actual future results may be materially different from what we expect. These forward-looking statements are
based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different
from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause actual
results or events to differ materially from current plans, intentions, and expectations include, among other things, those listed under
Part I, Item 1A. "Risk Factors," Part II, Item 7. "Management's Discussion and Analysis of Financial Condition
and Results of Operations" and elsewhere in this Annual Report on Form 10-K. Given these uncertainties, you should not rely on
these forward-looking statements as predictions of future events. The forward-looking statements contained in this Annual Report on Form
10-K are made as of the date of this Annual Report on Form 10-K, and we do not assume any obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise, except as required by applicable law.

 In
addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These
statements are based upon information available to us as of the date of this Annual Report on Form 10-K, and while we believe such information
forms a reasonable basis for such statements, such information may be limited or incomplete. Our statements should not be read to indicate
that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are
inherently uncertain and investors are cautioned not to unduly rely upon these statements.

 Unless
the context requires otherwise, references to the "Company," "Lantern," "we," "us," and
"our" in this Annual Report on Form 10-K refer to Lantern Pharma Inc., a Delaware corporation, and, where appropriate, its
wholly-owned subsidiaries.

 iii

 RISK
FACTOR SUMMARY

 Our
business is subject to numerous risks and uncertainties, including those described in Part I, Item 1A. "Risk Factors" in
this Annual Report on Form 10-K. These risks include, but are not limited to the following:

 We will need substantial additional funding in the near future, and if
we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development programs or commercialization
efforts.

 We
 have a limited operating history and have never generated any revenues other than from research grants, which may make it difficult
 to evaluate the success of our business to date and to assess our future viability.

 We
 have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses
 for the foreseeable future and may never achieve or maintain profitability.

 We
 have limited experience in drug discovery and drug development and may not receive regulatory approval to market our drug candidates.

 Our
 business strategy to rescue previously failed drug candidates may not be successful, and important issues relating to safety and
 efficacy remain to be resolved for all of our drug candidates. Our strategy also involves risks and uncertainties that differ from
 other biotechnology companies that focus solely on new drug candidates that do not have a history of failed clinical trials.

 We
 may depend on enrollment of patients with specific genomic or biomarker signatures in our clinical trials in order for us to continue
 development of our drug candidates. If we are unable to enroll patients with specific genomic or biomarker signatures in our clinical
 trials, our research, development and commercialization efforts could be adversely affected.

 Delays
 in clinical testing could result in increased costs to us and delay our ability to generate revenue.

 Disruptions at the FDA and other government agencies caused by
funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel,
or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could
negatively impact our business.

 Change in priorities at the FDA and other government agencies could hinder
our ability to develop and commercialize any of our product candidates in a timely manner.

 Our
 drug candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval,
 limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if
 any.

 Our
 RADR platform may fail to help us discover and develop additional potential drug candidates.

 Any
 failure by us to comply with existing regulations could harm our reputation and operating results.

 Our
 inability to obtain and retain sufficient clinical trial liability insurance at an acceptable cost to protect against potential liability
 claims could prevent or inhibit our ability to conduct clinical trials for drug candidates we develop.

 Even
 if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing one or
 more of our drug candidates.

 If
 our drugs do not gain market acceptance, our business will suffer because we might not be able to fund future operations.

 Failure
 to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad.

 Any
 drug candidate that we obtain marketing approval for could be subject to post-marketing restrictions or withdrawal from the market
 and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated
 problems with our drugs, when and if any of them are approved.

 iv

 Even
 if we obtain regulatory approvals to commercialize LP-300, LP-184, LP-284 or our other drug candidates, our drug candidates may not
 be accepted by physicians or the medical community in general.

 Healthcare
 reform measures could hinder or prevent our drug candidates' commercial success.

 Governments
 outside of the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

 We
 rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully perform
 their contractual legal and regulatory duties or meet expected deadlines, we may not be able to obtain regulatory approval for or
 commercialize our drug candidates and our business could be substantially harmed.

 We
 are substantially dependent on third parties for the manufacture of our clinical supplies of our drug candidates, and we intend to
 rely on third parties to produce commercial supplies of any approved drug candidate. Therefore, our development of our drugs could
 be stopped or delayed, and our commercialization of any future drug could be stopped or delayed or made less profitable if third
 party manufacturers fail to obtain approval of the FDA or comparable regulatory authorities or fail to provide us with drug products
 in sufficient quantities or at acceptable prices.

 We,
 or third-party manufacturers on whom we rely, may be unable to successfully scale-up manufacturing of our drug candidates in sufficient
 quality and quantity, which would delay or prevent us from developing our drug candidates and commercializing approved drugs, if
 any.

 We
 have obtained statistical data, market data and other industry data and forecasts used throughout this report from market research,
 publicly available information and industry publications which we believe are reliable but have not been verified by any third party.

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

 We
 may be subject to claims by third parties asserting that our employees, consultants, contractors or advisors have wrongfully used
 or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their intellectual
 property or claiming ownership of what we regard as our own intellectual property.

 Our
 stock price has been volatile and often thinly traded, which may impair your ability to sell your shares.

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

 We
 may be at risk of securities class action litigation.

 Our
 certificate of incorporation and our by-laws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent
 a change in control, which may cause our stock price to decline.

 v

 PART
I

 Item
1. Business

 We
are an artificial intelligence (A.I.) focused company dedicated to developing cancer therapies and transforming the cost, pace, and timeline
of oncology drug discovery and development. Our development portfolio includes three clinical stage oncology focused product candidates
and consists of small molecules that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds
that we are developing with the assistance of our proprietary A.I. platform and our biomarker driven approach. Our A.I. platform, known
as RADR, currently includes more than 100 billion data points, and uses big data analytics (combining molecular data,
drug efficacy data, data from historical studies, data from scientific literature, phenotypic data from trials and publications, and
mechanistic pathway data) and machine learning to rapidly uncover biologically relevant genomic signatures correlated to drug response,
and then identify the cancer patients that we believe may benefit most from our compounds. This data-driven, genomically-targeted and
biomarker-driven approach allows us to pursue a transformational drug development strategy that identifies, rescues or develops, and
advances potential small molecule drug candidates at what we believe is a fraction of the time and cost associated with traditional cancer
drug development.

 We
now have active clinical programs for our three lead
small molecule drug candidates: LP-300, LP-184, and LP-284. These programs are focused on multiple
important cancer indications, including both solid tumors and blood cancers. We have established a wholly-owned subsidiary, Starlight
Therapeutics, to focus exclusively on the clinical development of our promising opportunities for central nervous system (" CNS")
and brain cancers, many of which have no effective treatment options. We are also advancing an antibody-drug conjugate ("ADC")
program focused on developing highly specific ADCs with highly potent drug-payloads.

 Our
strategy is to both develop new drug candidates using our RADR platform and other machine learning driven methodologies,
and to pursue the development of drug candidates that have undergone previous clinical trial testing or that may have been halted in
development or deprioritized because of insufficient clinical trial efficacy (i.e., a meaningful treatment benefit relevant for the disease
or condition under study as measured against the comparator treatment used in the relevant clinical testing) or for strategic reasons
by the owner or development team responsible for the compound. Importantly, these historical drug candidates appear to have been well-tolerated
in many instances, and often have considerable data from previous toxicity, tolerability and ADME (absorption, distribution, metabolism,
and excretion) studies that have been completed. Additionally, these drug candidates may also have a body of existing data supporting
the potential mechanism(s) by which they achieve their intended biologic effect, but often require more targeted trials in a stratified
group of patients to demonstrate statistically meaningful results. Our dual approach to both develop de-novo, biomarker-guided drug candidates
and "rescue" historical drug candidates by leveraging A.I., recent advances in genomics, computational biology and cloud
computing is emblematic of a new era in drug development that is being driven by data-intensive approaches meant to de-risk development
and accelerate the clinical trial process. In this context, we intend to create a diverse portfolio of oncology drug candidates for further
development towards regulatory and marketing approval with the objective of establishing a leading A.I.-driven, methodology for treating
the right patient with the right oncology therapy.

 A
key component of our strategy is to target specific cancer patient populations and treatment indications identified by leveraging our
RADR platform, a proprietary A.I. enabled engine created and owned by us. We believe the combination of our therapeutic
area expertise, our A.I. expertise, and our ability to identify and develop promising drug candidates through our collaborative relationships
with research institutions in selected areas of oncology gives us a significant competitive advantage. Our RADR platform
has been developed and refined over the last several years and integrates billions of data points immediately relevant for oncology drug
development and patient response prediction using artificial intelligence and proprietary machine learning algorithms. By identifying
clinical candidates, together with relevant genomic and phenotypic data, we believe our approach will help us design more efficient preclinical
studies, and more targeted clinical trials, thereby accelerating our drug candidates' time to approval and eventually to market.
Although we have not yet applied for or received regulatory or marketing approval for any of our drug candidates, we believe our RADR
 platform has the ability to reduce the cost and time to bring drug candidates to specifically targeted patient groups. We believe
we have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that
leverages artificial intelligence along with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic
areas to address today's treatment needs.

 Scientific
literature offers a definition for "drug rescue" as research involving abandoned small molecules and biologics that have
not been approved by the U.S. Food and Drug Administration ("FDA"). These rescued molecular compounds are often abandoned
by pharmaceutical companies in the drug discovery or preclinical testing phase, typically because they do not prove effective for the
specific use for which they were developed. Some of these compounds may be useful in treating other diseases for which they have not
been tested. See, Hemphill, Thomas A., "The NIH Promotes Drug Repurposing and Rescue," Research Technology Management,
v. 5, no. 5, pp. 6-8 (2012). Our use of the term "rescue", "drug rescue", or "drug rescuing" refers
to, " a system of developing new uses for chemical and biological entities that previously were investigated in clinical
studies but not further developed or submitted for regulatory approval, or had to be removed from the market for safety reasons.",
which is a definition we believe is recognized in the drug discovery, drug development and pharmaceutical and biotechnology industries.
 See, Naylor, S. and Schonfeld J., "Therapeutic Drug Repurposing, Repositioning and Rescue," DDW (Drug Discovery World)
Winter 2014, and Mucke, HAM, A New Journal for the Drug Repurposing Community. Drug Repurposing, Rescue & Repositioning 1, 3-4 (2014).
The use of the term "drug rescue," "rescuing," or words of similar meaning in this report should not be construed
to mean that our RADR platform has resolved all issues of safety and/or efficacy for any of our drug candidates. Issues
of safety and efficacy for any drug candidate may only be determined by the U.S. FDA or other applicable regulatory authorities in jurisdictions
outside the United States.

 Our
current portfolio consists of three lead drug candidates that are in clinical phases (known as LP-300, LP-184 and LP-284) and an Antibody
Drug Conjugate (ADC) program that is in preclinical research optimization. In January 2023, we formed a wholly owned subsidiary, Starlight
Therapeutics Inc. ("Starlight"), to develop drug candidate LP-184's central nervous system (CNS) and brain cancer indications
– including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers. Following the formation
of Starlight, we refer to the molecule LP-184, as it is developed in CNS indications, as "STAR-001". All of these drug candidates
and our ADC program are leveraging precision oncology, A.I. and genomic driven approaches to accelerate and direct development efforts.

 We
are currently conducting a targeted phase 2 trial (the Harmonic trial) for LP-300 in never smoking patients with NSCLC in combination
with chemotherapy, under an existing investigational new drug application. Our candidate LP-184 has shown promising in-vitro and
 in vivo anticancer activity in multiple solid tumor indications (including pancreatic, glioblastoma and triple negative breast
cancer), and it is advancing in a Phase 1A clinical trial. Our candidate LP-284 has shown promising in-vitro
 and in vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184.
LP-284 is advancing in a Phase 1A clinical trial that commenced in the fourth quarter of 2023.

 Our
ADC program has also continued to advance. During 2024, we continued to progress the application of our RADR
A.I. platform to advance and refine an A.I. powered module focused on improving the precision, cost and timelines of ADC development for
cancer. In 2023, we entered into a research collaboration with
Bielefeld University in Germany focused on development of ADCs utilizing cryptophycin as the ADC drug-payload. Cryptophycins are promising
antitumor molecules that have demonstrated potency at ultra-low, picomolar, concentrations. In a broad range of preclinical studies,
the cryptophycin-ADC synthesized as part of the Bielefeld collaboration demonstrated promising
picomolar level potency and anti-tumor activity in multiple solid tumor cell lines, including breast, bladder, colorectal, gastric, pancreatic
and ovarian.

 In
addition to our lead drug candidates and ADC program, we also have an additional drug candidate, LP-100, that we believe has potential
for future development in combination with the class of anticancer agents known as PARP inhibitors (PARPi). For LP-100, as well as our
lead drug candidate LP-300, we are leveraging data from prior preclinical studies and clinical trials, along with insights generated
from our A.I. platform, to target the types of tumors and patient groups we believe will be most responsive to the drug. Both LP-100
and LP-300 showed promise in important patient subgroups, but failed pivotal Phase 3 trials when the overall results did not meet the
predefined clinical endpoints. We believe that this was due to a lack of biomarker-driven patient stratification.

has been studied in multiple randomized, controlled, multi-center non-small cell lung cancer, or NSCLC, trials that included administration
of either paclitaxel and cisplatin and/or docetaxel and cisplatin. LP-100 has previously been in a genomic signature guided phase 2 clinical
trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC). 9 patients (out of a targeted enrollment
of 27) were treated in the trial. The median overall survival (OS) for the initial group of 9 patients was approximately 12.5 months,
which is an improvement over other similar fourth-line treatment regimens for mCRPC. Based on our evaluation of the synergies of LP-100
with PARP inhibitors, the decision was made in the first quarter of 2023 to close the phase 2 clinical trial in Denmark, to allow the
focus of LP-100-directed resources on positioning the molecule for development in earlier lines of therapy with potentially larger market
opportunities. LP-100 was previously out-licensed by us to Allarity Therapeutics A/S. In July 2021, we entered into an Asset Purchase
Agreement to reacquire global development and commercialization rights for LP-100 from Allarity.

 Our
development strategy is to pursue an increasing number of oncology focused, molecularly targeted therapies where artificial intelligence
and genomic data can help us provide biological insights, reduce the risk associated with development efforts and help clarify potential
patient response. We plan on strategically evaluating these on a program-by-program basis as they advance into clinical development,
either to be done entirely by us or with out-licensing partners to maximize the commercial opportunity and reduce the time it takes to
bring the right drug to the right patient.

 As
part of our overall growth strategy, we plan to grow our pipeline by identifying new drug candidates and pursuing potential indications
for LP-300, LP-184, LP-284, our ADC program and other drug candidates while leveraging our RADR platform. We are also
pursuing the identification and design of potential combination therapies in cancer for our compounds by leveraging our RADR
 platform to analyze synergistic genomic networks and biological pathways with other currently approved drugs.

 We
have an extensive multi-national portfolio of intellectual property directed to our drug candidates, and to protect the targeted use
and development of our portfolio of compounds in specific patient populations and in specific therapeutic indications. In addition, as
our RADR platform and other machine learning driven methodologies progress and mature, we will continue to evaluate additional
ways to further protect these assets.

 As
of March 1, 2025, we own or control over 195 active patents and patent applications across 15 patent families whose claims are directed
to our drug candidates and what we plan to do with our drug candidates. We have in-licensed or acquired patents and patent applications
from AF Chemicals and BioNumerik Pharmaceuticals that are directed to the compounds LP-184, LP-284, LP-100 and LP-300, and methods of
using the compounds. Additionally, we have also filed patent applications to further enhance, and extend the use of these compounds. Our 15 patent families are directed to our drug candidates, their usage, manufacturing and other matters. These matters are
essential to precision oncology and relate to: (a) data-driven, biologically relevant biomarker signatures, (b) patient selection and
stratification approaches that rely on prediction of response derived from these signatures and, (c) the ability to develop novel, combination
therapy approaches with existing therapeutics.

 Our
Drug Candidate Pipeline

 One
of the ways we built our drug candidate pipeline is by in-licensing clinical stage drug candidates that may have been discontinued for
development. We use our RADR platform to assist in analyzing prior clinical research conducted by others to identify
small-molecule oncology drug candidates that have (i) a well-tolerated profile evidenced by completion of phase 1 clinical trials, and
(ii) demonstrated at least limited antitumor or anticancer activity in clinical trials. We intend to advance the drug candidates in our
pipeline as potential precision medicine treatments for cancer. Our targeted development workflow includes preclinical studies where
drug activity and associated gene signatures are identified, in part through strategic collaborations with some of the top academic institutions
and clinical translational centers in the world. Using this collaborative approach, together with innovative observations from our RADR
 platform, we intend to develop and add drug candidates for our pipeline with the objective of treating the right patient populations
with the right oncology therapies.

 Our
current pipeline of development programs includes our three lead small molecule drug candidates: LP-300, LP-184, and LP-284, and our
Antibody Drug Conjugate (ADC) program.

 (Sodium 2,2'-disulfanediyldiethanesulfonate) (Tavocept): We are currently advancing LP-300 in a phase 2
 clinical trial, the Harmonic trial, in combination with chemotherapy in never-smokers with NSCLC adenocarcinoma who relapsed
 while on tyrosine kinase inhibitor (TKI) therapy.

 LP-184.
 ( (-) hydroxyureamethylacylfulvene): LP-184 is a synthetic small molecule drug with nanomolar potency that has potential for
 treatment of solid tumors including breast, pancreatic, bladder, and lung cancers, and glioblastoma and other CNS cancers. LP-184
 preferentially damages DNA in cancer cells overexpressing specific biomarkers. We are advancing LP-184 in a phase 1 clinical trial.
 Following the formation of Starlight Therapeutics in early 2023, we now refer to the molecule LP-184, as it is developed in CNS indications,
 as "STAR-001".

 LP-284.
 ( (+) hydroxyureamethylacylfulvene): LP-284, the stereoisomer (enantiomer) of LP-184, has shown promising in-vitro
 and in vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184.
 We are advancing LP-284 in a phase 1 clinical trial.

 ADC
 Program: Our ADC program continues to advance. During 2024, we applied our RADR A.I. platform to advance an A.I.
 powered module focused on improving the precision, cost and timelines of ADC development for cancer. In 2023 we entered into a
 research collaboration with Bielefeld University in Germany focused on development of ADCs utilizing cryptophycin as the ADC
 drug-payload. Cryptophycins are promising antitumor molecules that have demonstrated potency at ultra-low, picomolar,
 concentrations.

 We
currently have INDs in the U.S. for LP-300, LP-184 and LP-284.

 Our
Precision Cancer Therapy Development Using Our Innovative RADR Platform

 We
believe RADR is one of the world's largest A.I. and machine learning (M.L.) oncology drug discovery and
development platforms, consisting of over 100+ billion oncology-focused data points. These data points consist of large-scale
multi-omic data, derived from 130,000+ patient records, 150+ drug-tumor interactions, thousands of drug classes, and covering over
135 cancer subtypes. RADR leverages this data and over 200+ advanced ML algorithms to power its drug discovery and
development modules. RADR 's data, capabilities, and insights have powered the development of new Lantern drug
candidates, advancement of new indications for existing drugs, and identification of potential new drug combinations.

 Historically,
cancer treatment protocols include surgery, chemotherapy and radiation therapy. Treatments have been selected based on histologic type
and disease spread, irrespective of genetic differences among patients. With the advent of precision therapies, cancer treatments increasingly
target specific genes or mechanisms of action for a more personalized approach to patient care. This trend represents a substantial advance
in cancer treatment because tumor growth is highly dependent on genetic changes and the genetic profile of the individual and the progression
of the disease is highly variable amongst patients.

 Our
RADR platform is core to our drug development approach for identifying the desired candidates to in-license and develop.
Oncology drug development is exceedingly challenging, with an overall estimated Phase 1-to-approval probability of success of just 3.3
percent (according to reports from DIA Global Forum: What Are the Chances of Getting a Cancer Drug Approved?, May 2019)
and an estimated mean cost to deliver a new oncology medicine of $4.4 billion (Study published in Targeted Oncology, 2023; Analysis
of the Cost of Developing Oncology Drugs Approved by the FDA Between 1997 and 2020). There is a critical need to rescue clinical
research on drugs that have failed clinical trials in order to provide additional possible therapies for patients while reducing the
overall cost of therapeutic development. Many drug failures within oncology may be attributed to the heterogeneity of the tested patient
population, even though there may be a strongly positive therapeutic impact on certain patient subgroups within that population.

 As
data-centric and machine learning approaches are beginning to change the pace and scale of drug discovery and development, research and
development ("R&D") we believe efforts in large biopharma companies are beginning to shift away from traditional approaches
towards new data and A.I.-centric approaches. According to Deloitte Consulting, in Ten Years On | Measuring the return from pharmaceutical
innovation 2019, "decades of advances in science and technology have driven improvements in health care outcomes and influenced
stakeholder expectations of the role of the biopharmaceutical industry (biopharma)". The Deloitte Consulting report further describes
that R&D costs will, "shift from traditional discovery and trial execution to a process driven by large datasets, advanced
computing power and cloud storage". Continuing the trend of scientific advancement impacting biopharma, as noted in Deloitte's
2019 report, the findings in Deloitte's 2023 report show R&D returns rebounding, with regulatory challenges and the need for
AI integration remaining as key future hurdles for the industry.

 Analysts
estimate that this shift from traditional screening, and trial-based studies to leveraging in silico, data and A.I. methodologies has
driven a significant increase in the spending on A.I. by the biopharma and drug discovery community. According to GlobalData, the drive
to reduce drug development time and costs through AI-enhanced computer-aided drug design, coupled with a surge of AI-focused startups,
is projected to result in biopharma AI spending reaching $3 billion by 2025. As a result of these trends and changes in the R&D model
in biopharma, we believe that we, and companies that are using data-centric and A.I. centric approaches to drug discovery and development,
are in an ideal position to benefit from this industry shift that has the potential to help deliver drugs to the right patients faster,
with a higher degree of personalization and a potentially lower amount of average costs in the development cycle.

 Our
drug rescue approach leverages substantial prior research and development investments in candidates that were withdrawn from development
prior to submission for FDA approval. The large volume of failed compounds, recent developments that permit increased access to validated
genomic and biomarker data, and the rapid evolution of A.I. technology creates an opportunity to efficiently capitalize on these investments.

 Our
RADR platform is rapidly emerging as a robust and scalable platform for targeted cancer therapy development. Through
the use of A.I. and machine learning, RADR is designed to quickly identify and guide the development of compounds that
we can develop as potential oncology agents through either a process of drug rescue, drug repositioning or de-novo development. RADR
 is being developed through an accumulation and curation of genomic and biomarker data that is directly relevant to the measurement
and classification drug-tumor interaction, and clinical datapoints related to patient response and patient stratification.

 Predicting
optimal drug responses in cancer patients requires the identification and validation of predictive biomarkers. Our RADR platform
seeks to identify biomarkers to assist in selecting patients who have the highest likelihood to respond to our drug candidates. For
example, the targeted indications for our drug candidate LP-184 were chosen in part because they are known to highly express the
protein coding gene PTGR1. Our clinical development plans for LP-184 are intended to provide additional information regarding
biomarkers related to LP-184's molecular and cellular targets. This method of using and validating targeted biomarkers during
development and then using these biomarkers during future clinical trials can lead to shortening of the development timeline and
compression of costs associated with oncology drug development.

 Similarly,
we believe LP-300 targets molecular pathways that are more common in never smokers than in other groups and also targets kinases involved
in key signaling pathways involving enzymes critical for DNA synthesis and repair, such as Excision Repair Cross-Complementation Group
1 (ERCC1), Ribonucleotide Reductase 1 (RNR1), Ribonucleotide Reductase 2 (RNR2), as well as enzymes and proteins important in regulating
cell redox status, such as Thioredoxin (TRX), Peroxiredoxin (PRX), Glutaredoxin (GRX), and Protein Disulfide Isomerase (PDI).

 Our
RADR Platform

 The
human genome consists of 19,000 to 20,000 protein coding genes. One input record derived from available data bases and analyzed by our
RADR platform consists of datapoints (expression values) from approximately 20,000 genes, another input record type is
drug sensitivity data (IC20, IC50), and other sets include key clinical parameters from HIPAA compliant patient data and clinical histories.
Our RADR platform uses a data-driven gene feature selection methodology that is a combination of biology, informatics,
and statistics – computational biology. The architecture, tools and software of our platform are depicted in the figures below.

 We
developed our platform using primarily open-source third party supervised algorithms such as Neural Networks, Support Vector Machine,
Random Forest, K-Nearest Neighbors, Logistic Regression and Penalized Multivariate Regression. Each algorithm is trained with input data
to predict drug sensitivity (regressor models) and stratify patient response as responder or non-responder (classifier models). Model
tuning and optimization is then performed using a hyperparameter search algorithm in order to produce the predicted lowest cross validation
error. The models are then evaluated using traditional performance metrics such as accuracy, area under the curve, sensitivity, specificity,
precision, root mean square error and mean absolute error calculations.

 A
feature reduction algorithm is then used to reduce the number of genes under analysis to a biomarker gene panel of less than approximately
50 genes. This set of genes is intended to carry the highest coefficient to predict drug sensitivity and the highest variable importance
in classifying a responder from a non-responder. Genes that do not help in predicting the output variable are eliminated sequentially.

 Our
RADR Platform Workflow

 Our
RADR platform's proprietary workflow involves preliminary statistical analysis on approximately 18,000 features
typically from whole transcriptomic datasets reducing the set to approximately 2,000 features. This is followed by gene filtering via
biological and statistical methodologies yielding approximately 200 significant genes. The platform currently contains multiple feature selection
methods and multiple machine learning methods to analyze the drug and omics data, in order to fine tune the model and get better and improved
prediction accuracy. Feature selection ensures that genes that do not contribute to response prediction are excluded from the output
dataset. The prediction component subsequently applies an A.I.-driven reduction algorithm to the previously filtered genes generating
a targeted set of typically less than 50 candidate biomarkers predictive of response to a particular molecule. The figure below illustrates
RADR 's workflow.

 A
distinct and unique benefit of the RADR platform is its ability to integrate biological knowledge and data-driven feature
selection to generate hypothesis-free biomarker signatures. This can then aid in identifying novel targets for predictive screening and
drug development.

 Our
RADR platform is enabled through access to, and analysis of, a number of key datasets: (i) publicly available databases
(ii) data from commercial clinical studies and trials and (iii) our proprietary data generated from ex vivo 3D tumor models specific
to drug-tumor interactions. We incorporate automated supervised machine learning strategies along with big data analytics, statistics
and systems biology to facilitate identification of new correlations of genetic biomarkers with drug activity.

 The
value of the platform architecture is derived from its validation through the analysis of over 100 billion oncology-specific clinical
and preclinical data points, more than 154 drug-cancer interactions, thousands of drug classes, data covering more than 135 cancer subtypes,
and over 130,000 patient records from 16 databases, one of which is our internal database. RADR leverages this data and
over 200+ advanced ML algorithms to power its drug discovery and development modules. Our target objectives for additional data growth
efforts of the RADR platform include a focus on drug sensitivity data, combination treatment outcome data, and biomarker
data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development of new therapies. Additionally,
the RADR platform's generative A.I. capabilities, focusing on molecular optimization and automated feature extraction
to improve understanding and prediction of molecular dynamics, safety, and drug-drug interactions are planned to increase in functionality
and scope for both small molecule development and for ADC development, analytics and characterization.

 We use cancer cell line gene expression
profiles and drug sensitivity data (IC50) as one of the RADR platform's input types. In a population of 10 case studies our platform was able to distinguish
responders from non-responders with an average historical accuracy of over 80%. We have also used our platform to generate genetic signatures
that we believe to have applicability for the majority of FDA approved drug-tumor indications. External validation, through retrospective
data analysis, of patient datasets from 10 independent clinical studies achieved an average response prediction accuracy greater than
80%, and internal analysis of 120 drug-tumor interactions in cell lines achieved an accuracy of greater than 85%. The figure below illustrates
examples of RADR 's algorithms and how they can be used.

 We
have developed our platform in a cloud environment that efficiently uses parallel processing to analyze patient stratification and biomarker
selection. Best software engineering practices are followed while designing and developing our platform's architecture. In order
to track modifications in the software, a version control system is in place. We use a software release process, including a rigorous
regression testing process, to ensure functions and programs are working as designed.

 Our
platform uses a simple user input and GUI based AI architecture that can be used in many pharmaceutical research areas such as biomarker
identification, patient stratification, drug rescue and reposition by bioinformaticians, clinicians and trained wet-lab scientists.

 In
late 2021, the Code Ocean Platform, a secure cloud-based computing environment manager, was integrated into RADR. The
Code Ocean environment has upgraded RADR 's data organization, synchronization, scalability and accessibility. These
architecture changes have enhanced the reproducibility of RADR aided insights and analysis and created an environment
that improves the ability to collaborate and share insights within Lantern and with Lantern's collaborators. The figure below illustrates
ways that RADR 's modules can be used to facilitate drug discovery and development within Lantern and with our collaborators.

 Actuate
Therapeutics Collaboration Utilizing RADR Platform

 In
May 2021, we entered into a Collaboration Agreement with Actuate Therapeutics, Inc. ("Actuate"), a clinical stage private
biopharmaceutical company focused on the development of compounds for use in the treatment of cancer, and inflammatory diseases leading
to fibrosis. Pursuant to the agreement, we have collaborated on utilization of our RADR platform to develop
novel biomarker derived signatures for use with one of Actuate's product candidates. As part of the collaboration, we received shares of Actuate stock subject to meeting certain conditions of the collaboration, as well as the potential to receive
additional Actuate stock if results from the collaboration are utilized in future development efforts.

 TTC
Oncology Collaboration to Expand the Clinical Development of Drug Candidate TTC-352

 In
February 2023, we entered into a Collaboration Agreement with TTC Oncology ("TTC"). The collaboration focused on using RADR
 to accelerate and sharpen the drug development of TTC's Phase 2 ready drug candidate TTC-352. TTC-352, is a novel, first-
and best-in-class selective human estrogen receptor (ER) partial agonist (ShERPA) for the treatment of patients with metastatic ER+ breast
cancer. TTC-352 was evaluated in a Phase 1 accelerated dose escalation study for hormone receptor positive metastatic breast cancer,
and it showed early anti-tumor activity signals in heavily pretreated hormone refractory patients. The aims of the collaboration were
to 1) identify biomarker or gene signatures to power potential patient selection for a planned TTC-352 Phase 2 clinical trial, 2) further
characterize TTC-352's mechanism of action, and 3) discover additional treatment indications for TTC-352.

 Oregon Therapeutics Collaboration to Optimize
Precision Development of Drug Candidate XCE853

 In mid-2024, we entered into a
strategic A.I.-driven collaboration with French biotechnology company, Oregon Therapeutics, to optimize the development of its first-in-class
protein disulfide isomerase (PDI) inhibitor drug candidate XCE853 in novel and targeted cancer indications. As part of the collaboration,
we have leveraged our proprietary RADR A.I. platform to uncover biomarkers and anticancer-associated signatures of XCE853
across solid tumors aimed at assisting in precision development. Oregon Therapeutics has focused on developing XCE853 in various cancer
indications, including drug-resistant ovarian and pancreatic cancer, certain hematological cancers and several pediatric cancers including
CNS cancers. The objectives of the collaboration have included a focus on 1) uncovering biomarkers and efficacy-associated gene signatures
to guide in the eventual stratification and selection of patients for future clinical trials, 2) efforts to identify tumor-based response
and resistance mechanisms to XCE853 and strategies to overcome treatment resistance, and 3) identification of opportunities to expand
the use of XCE853 in additional therapeutic cancer indications for XCE853.

 Our
Strategy

 Our
mission is to bring the right cancer drugs to the right patients by transforming the drug development process through the use of artificial
intelligence and data-driven development approaches. Our proprietary A.I.-enabled, and precision oncology approach, which focuses on
developing our own pipeline of compounds by rescuing drug candidates that have previously failed and developing new compounds that are
targeted to specific biological activity and genomic pathways, has the potential, we believe, to bring drugs to market faster, with lower
costs, and with reduced risk, thereby enabling a change in the cost and availability of precision cancer therapy. We work with leading
research laboratories, translational medicine and cancer centers to develop our studies and clinical trials for our portfolio, and actively
update and improve our RADR platform to incorporate additional biomarker data, patient outcome data, cancer drug efficacy
studies and computational models that relate to oncology drug development and prediction of patient response.

 As
part of our strategy, we plan to:

 Pursue
 existing indications for LP-300, LP-184, LP-284, our ADC program and are other product candidates, leveraging our RADR
 platform to refine and optimize our trial design and biomarker signatures that correlate to potential patient response.

 Expand
 our pipeline by identifying new drug candidates that have either been abandoned or have failed in late stage clinical trials, and
 have the potential to benefit from a precision medicine approach that leverages our expertise and A.I. platform.

 Identify
 and design potential combination therapy approaches to use our compounds in conjunction with currently approved drugs by leveraging
 our RADR platform to analyze and uncover synergistic mechanisms and biological pathways using genomics and machine
 learning.

 Advance
 the algorithms, methodologies and models that underlie our computational and machine learning platform to improve the predictive
 power, and to develop additional capabilities that are focused on accelerating or de-risking oncology drug development.

 Pursue
 collaborations and partnerships with other biotech and pharma companies where our A.I. and precision oncology expertise can be used
 to de-risk or accelerate development programs and where our stockholders can receive a significant economic benefit.

 Continue
 to develop and patent intellectual property and advance our intellectual property portfolio associated with both fundamental patents
 and patents associated with precision, patient stratified, targeted therapies and genomic or biomarker signatures.

 Continue
 to evaluate, select and launch additional clinical development programs.

 We
are currently advancing LP-300 in a Phase 2 clinical trial (the "HARMONIC Study") of LP-300 in combination with carboplatin
and pemetrexed in never smoker patients with relapsed advanced primary adenocarcinoma of the lung after treatment with tyrosine kinase
inhibitors (TKIs).

is a cysteine-modifying molecular entity that works to modulate multiple cellular pathways simultaneously and is a potential combination
agent for targeted indications in NSCLC. LP-300 is a small molecule (molecular weight 326.4 Da) that was in-licensed from BioNumerik
Pharmaceuticals, Inc. in May 2016, and subsequently acquired by us in 2018. We are focused on repositioning LP-300 as a potential combination
therapy for never smokers NSCLC patients with histologically defined adenocarcinoma. Prior clinical trials conducted by BioNumerik for
LP-300 did not meet their primary clinical endpoints, and at least one or more future clinical trials that meet their pre-specified primary
endpoints with statistical significance will be required before we can obtain a regulatory marketing approval, if any, to commercialize
LP-300. Safety and efficacy determinations are solely within the authority of the FDA in the U.S. or other regulatory agencies in other
jurisdictions. Currently there is no approved therapy specifically for the growing indication of never-smokers with NSCLC, and female
never smokers appear to be uniquely responsive to LP-300. With both chemosensitizing and chemoprotective activity, LP-300 has potential
as a combination agent or adjuvant in front line, second line or salvage therapy in newly diagnosed, relapsed, metastatic or advanced
NSCLC for overall survival enhancement and toxicity alleviation from primary chemotherapy or standard of care. We are currently in the
early stages of defining a specific biomarker signature that correlates with heightened sensitivity to LP-300. We believe that this signature
may help accelerate the clinical development of LP-300 and has the potential to guide patient selection for targeted clinical trials.

 Prior
clinical trials conducted by BioNumerik for LP-300 did not meet their primary clinical endpoints and at least one or more future clinical
trials that meet their pre-specified primary endpoints with statistical significance will be required before we can obtain a regulatory
marketing approval, if any, to commercialize LP-300. Prior clinical trial observations are not necessarily predictive of the outcome
of any future clinical trials we may conduct.

has been administered in multiple clinical trials to more than 1,000 subjects and has been generally well-tolerated. Retrospective analyses
of the results of a multi-country phase 3 lung cancer trial (study ID DMS32212R) in subgroups of adenocarcinoma patients receiving LP-300,
paclitaxel and cisplatin demonstrated substantial improvement in overall survival, particularly among female never smokers, where a 13.6
month improvement in overall survival (p-value 0.0167, hazard ratio 0.367) in favor of LP-300 was observed, as compared to placebo in
the subgroup of paclitaxel/cisplatin-treated patients. Similar retrospective findings of increased overall survival in the subgroup of
LP-300/paclitaxel/cisplatin treated female Asian patients with adenocarcinoma of the lung were observed in a randomized, double-blind,
placebo-controlled trial in Japan. Prior historical clinical trial observations are not necessarily predictive of the outcome of future
trials. No assurances can be given that we will be successful in obtaining marketing approval for LP-300. The chemical structure of LP-300
is depicted below.

Chemical Structure

Phase 2 Clinical Trial

 We
are conducting a Phase 2 clinical trial (the "HARMONIC Study") of LP-300 in combination with carboplatin and
pemetrexed in never smoker patients with relapsed advanced primary adenocarcinoma of the lung after treatment with tyrosine kinase
inhibitors. Our purpose in conducting the study is to determine the potential clinical advantages and benefit for this drug
combination in the study-defined patient population. As of the date of this report, we have 7 clinical trial sites in the US, 5
clinical trial sites in Japan, and 5 clinical trial sites in Taiwan. Enrollment of patients on the Harmonic Study in the U.S.
has been challenging, and we have implemented a strategy of increasing enrollment by expanding the study to East Asian countries
where approximately 30-35+% of all lung cancer cases occur in never-smokers with NSCLC.

 The
Harmonic Study is designed as a multicenter, open label, Phase 2 trial with planned future enrollment of approximately 90 patients.
Patients who are never smokers with lung adenocarcinoma and have relapsed after prior treatment with tyrosine kinase inhibitors will
be eligible for enrollment. Following completion of a six-patient safety lead-in stage, the trial advanced to the randomization stage,
which consists of enrolling patients in a 2:1 allocation ratio to one of two arms: Arm A (consisting of carboplatin, pemetrexed, and
LP-300) or Arm B (consisting of carboplatin and pemetrexed).

 The
primary objective of this study is to determine progression-free survival and overall survival in the study-defined patient population
when co-administered LP-300 with combination chemotherapy (carboplatin and pemetrexed) versus carboplatin and pemetrexed alone. The secondary
objectives of the study are to evaluate tumor response measured by objective response rate, duration of objective response, and clinical
benefit rate. We will also determine any associations between the efficacy endpoints and patient biomarkers (e.g., circulating tumor
DNA and tumor genome characteristics) as an exploratory objective. Other exploratory objectives for the study may include evaluating
quality of life in all patients and performance of patients based on the type, duration, and number of tyrosine kinase inhibitors received.

 Key
Findings from Prior LP-300 Clinical Trials

 Summarized
below are some key findings from LP-300's prior clinical trials:

 targets molecular pathways that are more common in female non-smokers than in any other group. Key mechanisms have been elucidated
 to support LP-300's role in the observed treatment benefits for females and never smokers noted in the Phase 3 NSCLC adenocarcinoma
 trial. The rationale for these observations includes the following: (1) Met/ALK & EGFR alterations are more common in non-smokers,
 who are most commonly female and present with advanced stage adenocarcinoma; (2) laboratory data indicate that LP-300 targets both
 EGFR WT/mut+ and Met/ALK; and (3) a high percentage of adenocarcinoma patients are either EGFR mutants or Met/ALK positive.

 There
 are several key pathways in NSCLC adenocarcinoma whose targets are often overexpressed in females, and LP-300 modulates these pathways.
 LP-300 targets the following key pathways: (1) kinases involved in key signaling pathways (ALK, ROS, MET); (2) enzymes critical for
 DNA synthesis and repair (ERCC1, RNR1, RNR2); and (3) enzymes and proteins important in regulating cell redox status (TRX, PRX, GRX,
 PDI). The alterations that are targeted and modulated by LP-300 are more likely in women with lung adenocarcinoma, especially non-smokers.

 showed that females had a survival increase from 13 months to 25 months, based on a retrospective subgroup analysis of a Phase 3
 NSCLC adenocarcinoma trial. Results from a Phase 3 NSCLC adenocarcinoma trial exhibited an overall survival of 25.0 months, with
 a 2-year survival of 51.4%, in the subgroup of females with advanced adenocarcinoma of the lung receiving paclitaxel/cisplatin and
 LP-300. The observed results were statistically significant (p-value = 0.0477; HR=0.579) and were observed in a subgroup of 114 patients
 in retrospective analyses. Consistent statistically significant retrospective subgroup analysis results were observed in female NSCLC
 adenocarcinoma patients receiving paclitaxel/cisplatin and LP-300 in a prior LP-300 double-blind, placebo-controlled phase 3 trial
 conducted in Japan.

 exhibits potential to reduce anemia and protect against chemotherapy-induced kidney toxicity, both of which are conditions that disproportionately
 affect females. The LP-300 arm of the Phase 3 NSCLC adenocarcinoma trial also demonstrated the potential for LP-300 to protect
 against chemotherapy-induced kidney toxicity and anemia. These findings complement earlier clinical observations regarding LP-300's
 potential to protect against neuropathy and other chemotherapy-induced toxicities.

 Background-Scope
of Prior Phase 3 NSCLC Adenocarcinoma Trial (LP-300)

was studied in a randomized, multi-center (trial locations in four US states and five European countries), double-blind and placebo-controlled
Phase 3 trial from 2010 to 2013 in patients with adenocarcinoma of the lung (the "Phase 3 NSCLC adenocarcinoma trial"). The
aim of the trial was to determine whether LP-300, combined with a standard combination of chemotherapy drugs, would increase survival
in patients with advanced NSCLC adenocarcinoma. The secondary aim of the trial was to determine if the chemoprotective properties of
LP-300 were effective in preventing or reducing common side-effects of cancer treatment, including kidney damage, anemia, nausea and
vomiting that can occur with these drug combinations. The trial enrolled NSCLC patients with newly diagnosed or recurrent advanced (stage
IIIB/IV) primary adenocarcinoma of the lung. Patients with confirmed histopathological diagnosis of inoperable and measurable advanced
primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung, and no prior systemic treatment for NSCLC including chemotherapy,
immunotherapy, hormonal therapy, targeted therapies or investigational drugs, were included in the trial. Overall survival was the primary
outcome measure. Patients in the control arm received standard of care (cisplatin and either paclitaxel or docetaxel) plus placebo, whereas
patients in the treatment arm received standard of care (cisplatin and either paclitaxel or docetaxel) plus LP-300. The primary results
of the trial for patients receiving cisplatin and paclitaxel are outlined in the table below. While the overall results of the Phase
3 NSCLC adenocarcinoma trial did not meet the specified endpoint of the trial in increasing overall survival in all patients, when the
data were retrospectively separated by gender and smoking status, the trial data demonstrated that all never smokers, especially female
never smokers, saw increased survival with LP-300 combination treatment with paclitaxel and cisplatin. Furthermore, the LP-300 group
in the phase 3 NSCLC adenocarcinoma trial exhibited well-tolerated advantages relating to the potential to protect against chemotherapy-induced
nephrotoxicity, neuropathy and nausea along with reduced anemia.

 The
figure below depicts the survival curves for cisplatin/paclitaxel subgroups for the Phase 3 NSCLC adenocarcinoma trial that ended in
2013, as summarized. The Kaplan Meier curves maintain consistent separation between treatment arms for the never smokers, females, and
female never smokers.

 Rationale
Behind LP-300 Rescue and Repositioning Efforts

 Based
on the results from the prior Phase 3 NSCL adenocarcinoma trial, we have launched the HARMONIC LP-300 Phase 2 clinical trial to
target the subpopulation of never smokers with adenocarcinoma that saw strong benefit in the previous Phase 3 trial. Although the incidence
of never-smokers with NSCLC is rising currently there is no approved therapy specifically for the growing indication of never-smokers
with NSCLC. Preclinical observations support that LP-300 preferentially modulates ALK and EGFR, two commonly mutated genes in non-smokers
with adenocarcinoma. Based on the findings from the previous Phase 3 NSCL adenocarcinoma trial, it is possible that the benefits of combining
LP-300 with standard of care chemotherapy could be further improved by identifying additional molecular biomarkers in patients who respond
well to LP-300 combination treatment. We continue to seek additional opportunities for LP-300. Some of our considerations include a never
smoker population with a specific genetic signature that correlates to increased LP-300 sensitivity.

 Disease
Background and Opportunity

 Lung
cancer is the second most prevalent cancer globally, and it accounts for the highest level of cancer-related deaths worldwide. Lung cancer
accounts for approximately 12% of all new cancer diagnoses, but 21% of all cancer deaths in the US. Lung cancer kills more people annually
than cancers of the breast, prostate, colon, liver, kidney, pancreatic, and melanoma combined. The American Cancer Society's estimates
for lung cancer in the US for 2025 are:

 226,650 new cases of lung cancer (110,680 in men and 115,970 in women)

 124,730 deaths from lung cancer (64,190 in men and 60,540 in women)

 The
most common type of lung cancer is called non-small cell lung cancer ("NSCLC"), which represents about 80% to 85% of all
lung cancer.

 Lung
adenocarcinoma, a histological subtype of NSCLC that originates within the glands that line the lung, is the most common subtype of lung
cancer in the world inflicting approximately 50% to 65% of non-Asians and approximately 70% to 85% of Asians diagnosed with lung cancer.
According to LUNGevity Foundation, the National Institutes of Health and other published literature, 60% to 65% of all new lung cancer
diagnoses are among people who are former smokers or have never smoked, while 10-15% of new lung cancer cases are among never-smokers.

 Over
one-half of the patients diagnosed with NSCLC in any given year will present with inoperable advanced (stage IV) disease, for which there
is no cure. Patients with stage IV NSCLC exhibit a median overall survival time of 7 to 12 months; approximately one-third of patients
will survive for a year, and only 10% to 21% of those patients will survive for two years.

 Lung
cancer is the most common cause of global cancer-related mortality, leading to over a million deaths each year and adenocarcinoma is
its most common histological subtype. Worldwide, lung cancer occurred in approximately 2.5 million patients in 2022 and caused an estimated
1.8 million deaths. NSCLC is described as any type of epithelial lung cancer other than small cell lung cancer ("SCLC").
The 5-year survival rate for NSCLC is 28%.

 Rapid
advances in understanding the molecular pathogenesis of NSCLC have demonstrated that NSCLC is a heterogeneous group of diseases. Although
the initial treatment of localized disease is the same, the molecular characterization of tumor tissue in patients with NSCLC serves
as a guide to treatment both in those who present with metastatic disease and in those who relapse after primary therapy. Molecularly
targeted therapies have dramatically improved treatment for patients whose tumors harbor somatically activated oncogenes such as mutant
EGFR1 or translocated ALK, RET, or ROS1. Smoking is the major cause of lung adenocarcinoma but, as smoking rates decrease, proportionally
more cases occur in never-smokers (defined as less than 100 cigarettes in a lifetime). KRAS mutations in lung cancer cases are nearly
exclusive to smokers. KRAS, "Kristen rat sarcoma viral oncogene homolog," is a protein involved in regulating cell division.
KRAS mutation is a gain-of-function mutation (i.e. somatic mutation turns RAS, a benign gene "proto-oncogene" into KRAS,
an oncogenic driver of many tumors). KRAS-mutated non-small cell lung cancer represents 20% to 25% of all NSCLC. In 2022, FDA granted
accelerated approval to Antibody Drug Conjugate trastuzumab deruxtecan (Enhertu) for HER2 mutated advanced stages of non-small cell lung
cancer (NSCLC). In 2022, the combination of CTLA-4 inhibitor tremelimumab and the anti-PDL1 antibody durvalumab was approved by FDA for
treating metastatic NSCLC patients lacking EGFR mutation or ALK translocation. In 2023, FDA approvals included pralsetinib (Gavreto)
for RET fusion-positive NSCLC and repotrectinib (Augtyro) for ROS1-positive NSCLC, offering the first approval for both TKI-na ve
and previously treated patients. In 2024, the FDA approved Osimertinib (Tagrisso) in combination with platinum-based chemotherapy for
EGFR-mutated NSCLC. Amivantamab-vmjw (Rybrevant) was also approved, in combination with carboplatin and pemetrexed, as a first-line treatment
for NSCLC with EGFR exon 20 insertion mutations. Additionally, ensartinib was approved for first-line treatment in ALK-positive, advanced
or metastatic NSCLC patients who had not previously received an ALK inhibitor. Tepotinib (Tepmetko) was approved for patients with MET
exon 14 skipping alterations, and alectinib (Alecensa) was approved for adjuvant treatment after tumor resection in ALK-positive NSCLC
patients, as detected by an FDA-approved test. Tumor suppressor gene abnormalities, such as those in TP53, CDKN2A8, KEAP1, and SMARCA4
are also common but are not currently clinically actionable.

 In
reviewing lung cancer incidence and mortality rates among never-smokers in the Journal of Clinical Oncology, Wakelee, H.A. et al. have
reported that the age-adjusted incidence rates of lung cancer among never-smokers aged 40 to 79 years from large population-based cohorts
ranged from 14.4 to 20.8 per 100,000 person-years in women and 4.8 to 13.7 per 100,000 person-years in men, supporting earlier observations
that women are more likely than men to have never smoking-associated lung cancer. The biology of lung cancer in never-smokers is apparent
in differential responses to epidermal growth factor receptor inhibitors and an increased prevalence of adenocarcinoma histology in never-smokers.
Lung cancer in never-smokers is an important public health issue needing further exploration of its incidence patterns, etiology, and
biology. Due to the fact that there are no known therapy options for this group, we believe that aggressive development of therapy options
is needed and is a high unmet clinical need.

 In
the US in 2025, there will be an estimated 11,444 diagnosed cases of NSCLC in female non-smokers, accounting for approximately 5% of
all lung cancer cases. Globally in 2022, there were an estimated 125,231 adenocarcinoma cases of NSCLC in female non-smokers. Due to
the specificity of this indication, it may be possible to classify it as a rare disease. When attempting to explain some gender susceptibility
differences, research has demonstrated that women with NSCLC tend to be:

 Younger;

 Asian;

 2-3
 times more likely to be non-smokers;

 more
 likely to develop adenocarcinoma and;

 more
 likely to have metastatic disease.

 The
high rate of adenocarcinomas in non-smoking women suggests the possible existence of other etiological factors in addition to smoking.
Some factors that have been considered include gender-specific genetic alterations and predispositions, passive smoke effects, different
nicotine metabolism in women, occupational exposure, diet, and chronic obstructive pulmonary disease. Based upon estimates published
by Global Cancer Statistics 2022 and 2025 estimates published by the American Cancer Society, below is an overview of relevant potential
patient population and market sizes that we believe LP-300 could address, if approved:

 Lung cancer

 Global
 (2022)

 US
 (2025)

 Total lung cancer estimated incidence (new cases)

 2,480,301

 226,650

 NSCLC incidence (~85% of all lung cancer cases)

 2,108,256

 192,653

 NSCLC adenocarcinoma incidence (~60% of all NSCLC)

 1,264,954

 115,592

 Never-smokers estimate (~15% of adenocarcinoma)

 189,744

 17,338

 Female never-smoker estimate (~66% of never-smokers with lung cancer are female)

 125,231

 11,444

 Total Potential Patient Segment in New Lung Cancer

 5.0%-7.6
 %

 5.0%-7.6
 %

 Limitations
on Current Treatment

 Treatment
of patients with advanced NSCLC in the first-line setting usually includes chemotherapy (including taxanes, vinorelbine, or gemcitabine)
in combination with a platinum doublet (cisplatin or carboplatin). According to the clinical practice guidelines published by the National
Comprehensive Cancer Network, many of these combinations have reached a plateau in terms of overall response ( 25% to 35%), time
to progression (four to six months), median survival time (eight to ten months), one-year survival rate (30% to 40%), and two-year survival
rate (10% to 15%) in patients with good performance status. Treatment remains palliative and is limited due to inherent toxicities that
may affect the quality of life resulting from treatment. Toxicities can be life-threatening or cause treatment delays, thereby limiting
the intensity of treatment delivered and affecting its efficacy. Common and serious chemotherapy-induced toxicities, such as anemia,
emesis, and peripheral neurotoxicity resulting from treatment with platinum and taxanes, and nephrotoxicity due to cisplatin can result
in treatment delays, dose modifications, and in severe cases, discontinuation of treatment.

 The
identification of gene mutations in lung cancer has led to the development of molecularly targeted therapy to improve the survival of
subsets of patients with metastatic disease. In particular, genetic abnormalities in EGFR, MAPK, and PI3K signaling
pathways in subsets of NSCLC may define mechanisms of drug sensitivity and primary or acquired resistance to tyrosine kinase inhibitors
(TKIs). To date, approximately 21 TKIs have been approved for use in treating NSCLC with identified tyrosine kinase (TK) mutations; the
TKs targeted by these inhibitors include EGFR, ALK, ROS1, BRAF/MEK, RET, and MET. If patients are found to have specific TK mutations
to which inhibitors are known to respond, treatment with such TKIs is currently standard-of-care for this population of advanced NSCLC.
Most tumors will respond to initial treatment with TKIs, exhibiting tumor shrinking or delayed progression. Unfortunately, most patients
will eventually develop resistance to the inhibitory effects of initial used inhibitors. Therefore, second- or third-line therapy often
involves treatment with alternate inhibitors targeting the same kinase but with differing mutations. Such treatment again is often initially
successful, but further kinase mutations, or mutations arising in different kinases, often leads to relapse and the need to switch to
alternative treatment schemes. This next therapy usually involves chemotherapy (often carboplatin plus pemetrexed), sometimes used in
combination with immunotherapy, or enrollment in clinical trials testing new treatment approaches.

 We
believe it is important to pursue the development of novel therapies and combinations thereof that can substantially improve patient
survival and quality of life by potentiating the antitumor activity of chemotherapy treatment while protecting against chemotherapy-induced
toxicity.

Opportunity

 Most
never-smoker patients with lung cancer are women, and adenocarcinoma is the most common type. Non-smoker patients with non-small-cell
lung cancer ("NSCLC") generally have a better response to inhibitors of epidermal-growth-factor receptor (EGFR) tyrosine
kinase, including without limitation gefitinib and erlotinib, than do those with a history of tobacco smoking. Studies have identified
differences in chromosomal aberrations, genetic polymorphisms, gene mutations, and methylation status between lung cancer in non-smokers
and tobacco-associated lung cancer. These clinical and biological differences suggest that the two cancers have overlapping but unique
pathways of carcinogenesis. The EGFR mutation is one of the most important genetic change in lung cancer in people who have never smoked
because it is more common in lung cancer in never-smokers than in tobacco associated lung cancer and is associated with greater therapeutic
benefit from inhibitors of EGFR. Other alterations associated with never-smokers include mutations, fusions or amplifications in ALK,
ROS1, RET and MET genes. Based on published articles in JCI Insight, 2024: The genomic landscape of lung cancer in never-smokers
from the Women's Health Initiative, lung cancer in never-smokers accounts for 10-15% of US cases and up to 20% globally,
with recent trends showing an increase to 17% in men and 24% in women in never-smokers. As detailed in the study "Characteristics
of never-smoker lung cancer patients in Korea" published in Lung Cancer, 2004, in Asia, over 30% of patients with lung cancer
are never-smokers, with at least 50% of lung cancers occurring in women who have never smoked.

 We
are focused on advancing LP-300 as a potential combination therapy for never smoking NSCLC patients with adenocarcinoma by leveraging
our A.I. platform to help uncover the genomic and biomarker networks that are associated with response in the never-smoker and non-smoker
groups. Additionally, through our early, preclinical work to define a gene signature that correlates with heightened sensitivity to LP-300,
we believe there is potential to further expand the indication to include all NSCLC patients that have this identified genetic profile
in their cancer. Currently there is no approved therapy specifically for the growing indication of never-smokers with NSCLC, and female
never smokers appear to be uniquely responsive to LP-300. If successful, LP-300 could provide improved patient benefit in terms of improved
survival, and secondarily through the concurrent prevention and mitigation of common and serious chemotherapy-induced toxicities.

 Prior
Completed Trials of LP-300

 Phase
1. LP-300 has been evaluated in five Phase 1 studies (DMS10001, BioNumerik, 09/1997 through 04/2004; DMS10002, BioNumerik, 12/1997
through 08/2001; DMS12209, ASKA Pharmaceutical, 04/2000 through 12/2001; DMS10011, BioNumerik, 02/2006 through 07/2006; and DMS12307,
Baxter, 07/2002 through 07/2005) to determine the maximum tolerated dose ("MTD"), and to evaluate the safety, tolerability,
pharmacokinetics, and potential efficacy of LP-300 (alone or in combination with cisplatin, cisplatin/paclitaxel, or carboplatin/paclitaxel).
An MTD for LP-300 was not reached in any of the Phase 1 studies at dose levels of up to 41 g/m 2.

 Phase
2. In a U.S. multi-center, randomized, open-label trial (n=160 patients) with advanced (Stage IIIB and IV) NSCLC treated with LP-300
or no LP-300 (DMS22210/CALGB 30303, Cancer and Leukemia Group B, 08/2004 through 03/2007), although the overall population did not meet
the pre-specified primary endpoint, an analysis of a subgroup of patients with adenocarcinoma revealed that the difference in the median
overall survival period between the 2 treatment groups was statistically significant (LP-300 = 15.6 months, no LP-300 = 8.9 months; Log-rank
p=0.0326), and the median overall survival for patients who received LP-300 was 6.7 months longer than that of those who did not receive
LP-300.

 Phase
3. LP-300 has been evaluated in five Phase 3 studies: two in patients with metastatic breast cancer, with a primary endpoint examining
the ability to reduce platinum/taxane induced peripheral neuropathy, and three in patients with NSCLC or advanced primary lung adenocarcinoma.
(DMS32205R, ASKA Pharmaceutical, 08/2005 through 02/2008; DMS30203R, BioNumerik, 09/2001 through 10/2006; DMS30204R, ASKA Pharmaceutical,
04/2003 through 03/2006; DMS32206R, Baxter, 10/2002 through 04/2006; and DMS32212R, BioNumerik, 04/2010 through 06/2013) Although the
overall population did not meet the pre-specified primary endpoints in any of the trials, analysis of subgroups of patients in one multi-country
lung adenocarcinoma trial and one Japanese NSCLC trial revealed differences in the median overall survival between the two treatment
arms (with or without LP-300 treatment). The results from the two key lung cancer trials obtained from retrospective analyses are described
below:

 Multi-country,
 double-blind, randomized, multi-center & placebo-controlled trial (n=540 patients) with advanced primary lung adenocarcinoma
 treated with LP-300 or Placebo & paclitaxel or docetaxel with cisplatin (DMS32212R). (the Phase 3 NSCLC adenocarcinoma trial)

 Treatment
 with LP-300 nearly doubled the Overall Survival in women receiving paclitaxel/cisplatin (25.0-month median OS in LP-300 arm vs. 13.2-month
 OS in control arm) and the results in this subgroup were statistically significant (P-value = 0.0477; HR = 0.579)

 For
 never smoking women with adenocarcinoma of the lung receiving paclitaxel/cisplatin, the Overall Survival in the LP-300 arm was more
 than double the control arm (27.0 months vs. 13.4 months, respectively) also being statistically significant in favor of LP-300 (P-value
 = 0.0167; HR = 0.367) and the 2-year survival was 72.4% in the LP-300 arm vs. 32.3% in the control arm.

 Statistically
 significant subgroup analyses and trends from this LP-300 Phase 3 NSCLC adenocarcinoma trial support repositioning LP-300 for non-
 or never smokers with adenocarcinoma of the lung.

 Randomized,
 double-blind, placebo-controlled and multi-center trial in patients with advanced NSCLC receiving paclitaxel & cisplatin (Japan
 Trial) (DMS32205R). The Japan Trial observations support and complement observations in the multi-country Phase 3 NSCLC adenocarcinoma
 trial. The observations for the female adenocarcinoma patient population in the LP-300 multi-country Phase 3 NSCLC adenocarcinoma
 trial are consistent with observations made for the subgroup of females with adenocarcinoma of the lung receiving paclitaxel/cisplatin
 and LP-300 or placebo in the Japan Trial. Although the overall population in the Japanese trial did not meet the pre-specified primary
 endpoint, a retrospective analysis of the subgroup consisting of female patients with adenocarcinoma revealed that the difference
 in the median overall survival period between the two treatment arms in this subgroup was significant (P-value = 0.0456, HR = 0.376).

 The
LP-300 arm of the multi-country Phase 3 NSCLC adenocarcinoma trial also demonstrated safety profile advantages in terms of the potential
to protect against chemotherapy-induced kidney toxicity and chemotherapy-induced anemia. These observations complemented earlier clinical
observations regarding LP-300's potential to protect against neuropathy and other chemotherapy-induced toxicities. Results from
these trials indicate that treatment with LP-300 may, in further clinical testing, lead to improved survival in female and non- or never
smoking patients with primary adenocarcinoma of the lung receiving cisplatin/paclitaxel combination chemotherapy.

 Phase
2 and 3 LP-300 Adverse Events Summary

 The
following summarizes adverse events reported from a total of 1,712 patients enrolled in five randomized multi-center phase 2 and phase
3 studies with chemotherapy, with or without LP-300. A total of 1,712 patients were enrolled in these studies, of which 856 patients
received LP-300 with chemotherapy.

 All
 Adverse Events (AEs). The most frequently-occurring adverse events in patients receiving LP-300 with chemotherapy were generally
 similar to patients receiving placebo or chemotherapy alone. These events included blood and lymphatic system disorders (myelosuppression
 manifested as anemia, leukopenia, lymphopenia, neutropenia, and thrombocytopenia; also including decreased hematocrit, hemoglobin,
 lymphocyte count, neutrophil count, red blood cell count, platelet count, and white blood cell count), with an incidence ranging
 from 12% to 83%; gastrointestinal disorders including constipation, abdominal pain, diarrhea, nausea, stomatitis, and vomiting, with
 an incidence ranging from 22% to 83%; general disorders and administrative site conditions including fatigue (ranging from 17% to
 85%); infusion/injection site pain/reactions (ranging from 12% to 18%); malaise (ranging from 16% to 28%); peripheral edema (ranging
 from 13% to 22%); pyrexia (ranging from 10% to 17%); infections and infestations disorders including nasopharyngitis (ranging from
 11% to 16%); investigations including increased liver function tests including ALT, AST, and alkaline phosphatase (ranging from approximately
 10% to 55%); increased blood lactate dehydrogenase (ranging from approximately 17% to 26%); increased blood urea or blood uric acid
 (ranging from approximately 11% to 32%); increased gamma-glutamyltransferase (ranging from approximately 23% to 33%); decreased total
 protein (ranging from approximately 12% to 21%); metabolic and nutritional disorders including weight decreased (ranging from 15%
 to 22%), anorexia (ranging from 14% to 82%), and hypomagnesemia (ranging from 22% to 30%); musculoskeletal and connective tissue
 disorders including arthralgia, back pain, and myalgia (ranging from 7% to 80%); nervous system disorders including dysgeusia (ranging
 from 12% to 22%), headache (ranging from 14% to 17%), and peripheral neuropathy (motor and sensory – ranging from 22% to 86%);
 psychiatric disorders including insomnia (ranging from 12% to 17%); respiratory, thoracic, and mediastinal disorders including dyspnea
 (ranging from 12% to 40%); skin and subcutaneous disorders including alopecia (ranging from 33% to 92%); rash (ranging from 22% to
 29%); nail disorder/discoloration (10%); and vascular disorders including angiopathy (ranging from 64% to 69%) and flushing (ranging
 from 15% to 39%).

 Treatment-Related
 Adverse Events. Frequently occurring treatment-related AEs experienced by patients receiving LP-300 with chemotherapy included
 gastrointestinal disorders manifesting as nausea and vomiting (ranging from 12% to 67%, and 12% to 32%, respectively); fatigue (ranging
 from 22% to 82%); infusion/injection site pain/reactions (ranging from 11% to 18%); increased ALT (alanine aminotransferase) and
 gamma-glutamyltransferase (ranging from approximately 13% to 18%, and approximately 11% to 12%, respectively); peripheral neuropathy
 (motor and sensory – ranging from 14% to 54%); and vascular disorders including angiopathy (ranging from 60% to 69%), and flushing
 (ranging from 8% to 11%).

 Serious
 Adverse Events (SAEs). 11% to 49% of patients receiving LP-300 with chemotherapy, and 7% to 42% of patients in control groups
 receiving chemotherapy alone experienced SAEs during randomized multicenter studies. Frequently-occurring SAEs in patients receiving
 LP-300 with chemotherapy included pneumonia, hypersensitivity or drug hypersensitivity, dyspnea, pyrexia and dehydration, diarrhea,
 anaphylactic shock or anaphylactic reactions, vomiting, disease progression, infection, bronchospasm, pleural effusion, pulmonary
 embolism, thrombosis, hemolysis, nausea, chills, fatigue, sudden death, neutropenic infection, sepsis, anorexia, neutropenia, febrile
 neutropenia, pneumonitis, rash, and hypotension. Multiple allergic reactions have been reported in clinical trials of LP-300, and
 some of these reactions have been severe. It is possible that patients could experience an allergic reaction that is life-threatening.
 Five reports of grade 3 or 4 hemolysis events with three fatal outcomes were reported in patients receiving LP-300 with chemotherapy
 in a study involving the weekly drug administration schedule. Two events of hemolysis were reported in a study involving drug administration
 every two weeks. No events of hemolysis were reported in studies using the three weeks schedule of administration, which is the administration
 schedule used for the multi-country Phase 3 NSCLC adenocarcinoma trial.

 Treatment-Related
 Serious Adverse Events. Approximately 7% of patients receiving LP-300 with chemotherapy experienced treatment-related SAEs during
 randomized multicenter studies. The most frequently-occurring treatment-related SAEs experienced by patients receiving LP-300 with
 chemotherapy were hypersensitivity or drug hypersensitivity (five and two patients, respectively) and neutropenia (six patients).
 Other treatment-related SAEs experienced by patients receiving LP-300 with chemotherapy included hemolysis, bronchospasm, febrile
 neutropenia, anemia, nausea, and pulmonary edema (three patients, each); chills, diarrhea, pyrexia, neutropenic infection, hyperglycemia,
 acute respiratory distress syndrome, pulmonary embolism, sudden death, infection, and rash (two patients, each); and angina pectoris,
 cardiac arrest, tachycardia, sudden hearing loss, abdominal pain, vomiting, adverse drug reaction, anaphylactic shock, C. difficile
 colitis, pneumonia, sepsis, chemical cystitis, thrombosis in device, dehydration, leukopenia, anorexia, atrial fibrillation,
 fatigue, weight decrease, muscle disorder, pain in extremity, dizziness, peripheral sensory neuropathy, dyspnea, hypotension, and
 thrombosis (one patient, each).

 Clinical
Evidence of Toxicity Protection by LP-300

 The
data from randomized multicenter studies of LP-300 and chemotherapy demonstrates objective evidence of several instances where treatment
with LP-300 appears to provide potential benefit in terms of preventing and mitigating chemotherapy-induced toxicities, particularly
in studies of LP-300 and chemotherapy in patients with advanced NSCLC. These data support that LP-300 has the potential to protect against
chemotherapy-induced toxicities, including gastrointestinal, renal, electrolyte disturbances, and anemia; and there is data supporting
the potential for LP-300 to protect against severe forms of these toxicities. In addition, treatment with LP-300 may protect against
severe platinum-induced hearing loss and dehydration.

Mechanism of Action

is a water-soluble disulfide compound that lacks a free thiol or sulfate moiety. We postulate this unique structure of LP-300 may allow
it to potentiate antitumor activity of certain types of cytotoxic chemotherapy, and exert chemoprotective effects, through distinct and
interrelated mechanisms. In plasma, the lack of a free thiol prevents untoward reactivity and drug-drug interactions, and thereby may
allow chemotherapeutic agents to retain their efficacy. Once inside the tumor cell, LP-300 is metabolized and may then potentiate antitumor
activity of cytotoxic certain types of chemotherapy. A significant fraction of LP-300 is taken up by the kidneys, where LP-300's
metabolites can interact with chemotherapy drugs, such as cisplatin, and potentially diminish the chemotherapy drug's ability to
cause organ damage. We believe the postulated mechanisms that can enhance tumor directed chemosensitivity include restoration of apoptotic
sensitivity thereby countering drug resistance; oxidative stress enhancement; anti-angiogenesis; decreased DNA synthesis and gene expression;
and decreased glutathione and precursors (limiting glutathione tumor-mediated drug resistance). When LP-300 accumulates in the kidneys
it appears to reduce the toxicity of certain drugs, such as cisplatin, that are excreted through the renal system.

 As
depicted in the model below, we believe LP-300 and its metabolites can modulate key components of the thioredoxin and glutaredoxin systems,
which are believed to be involved as major mechanisms of the potentially enhanced antitumor effects of LP-300 with chemotherapy. The
thioredoxin pathway is commonly upregulated in adenocarcinomas, and examination of primary lung tumors from non-smokers have shown significantly
increased gene expression of thioredoxin. Overexpression of thioredoxin in cancer cells has been postulated to lead to resistance to
apoptosis, increased cellular proliferation, increased gene expression, increased angiogenesis, increased conversion of DNA into RNA,
and resistance to oxidative stress induction. We believe the modulation of thioredoxin expression is important for the observed increases
in patient survival identified in retrospective analyses of certain subgroups of patients with primary adenocarcinoma of the lung receiving
LP-300 in conjunction with cisplatin and paclitaxel chemotherapy. Different glutaredoxin transcript variants have been found to be elevated
in transformed cells, and glutaredoxin isoforms (e.g., variants of glutaredoxin 2) have been found to be elevated in NSCLC cell lines,
lending evidence for potential roles of glutaredoxin in tumor progression.

 We
believe LP-300 and its metabolites may potentiate the antitumor activity of chemotherapy by:

 (1)
shifting the redox balance and concentrations of reduced forms of thioredoxin and glutaredoxin to inactive oxidized forms of thioredoxin
and glutaredoxin, thereby restoring apoptotic sensitivity, increasing sensitivity to oxidative stress, inhibiting cell growth and angiogenesis,
RNA to DNA synthesis, and growth signaling, and

 (2)
forming thioredoxin or glutaredoxin adducts, which as inactive forms lead to thioredoxin- and glutaredoxin-mediated reduction of downstream
targets in the cell that are important for tumor resistance to chemotherapy, angiogenesis and cell growth.

 Working
Model for LP-300 Mechanism of Action

 We
believe that LP-300 may potentiate antitumor activity of certain types of cytotoxic chemotherapy, and exert chemoprotective effects through
several distinct and interrelated mechanisms of action. LP-300 is a cysteine-modifying agent that appears to modulate multiple cellular
pathways simultaneously. Experimental data indicate that LP-300 modifies and/or modulates the following key pathways:

 Kinases
 involved in key signaling pathways (EGFR, ALK, ROS, MET)

 Enzymes
 critical for DNA synthesis and repair (ERCC1, RNR1, RNR2)

 Enzymes
 and proteins important in regulating cell redox status (TRX, PRX, GRX, PDI)

 The
following key mechanisms have been observed to support our belief that LP-300 has potential to play an important role in the treatment
of females and never smokers with NSCLC adenocarcinoma. We believe these mechanisms help to explain the retrospective subgroup observations
for females and never smokers receiving LP-300 together with cisplatin and paclitaxel in the Phase 3 NSCLC adenocarcinoma trial:

 targets cysteine residues. Computational and experimental data indicate that LP-300 demonstrates specificity towards cysteines.
 LP-300-mediated xenobiotic modulation of protein targets on cysteine results in distinct, (multi)target-specific effects correlated
 to the role of the cysteine residue(s) in the target.

 alone inhibits human ALK and stimulates the inhibitory effect of crizotinib on human ALK. Alterations in ALK, along with MET,
 ROS1 & PDGFRA are thought to underlie nearly 10% of NSCLC adenocarcinoma cancers. Liquid Chromatography (LC), Mass Spectrometry
 (MS) and X-ray structural data demonstrate that LP-300 covalently modifies human ALK on Cys1156 and Cys1235. Enzyme assay data demonstrates
 that LP-300 inhibits human ALK's kinase activity and stimulates the inhibitory effect of crizotinib on human ALK's kinase
 activity.

 inhibits human MET kinase activity and stimulates Staurosporine inhibition of human MET kinase activity. Mesenchymal Epithelial
 Transition Factor Kinase (MET) kinase mutations and amplification are an important, specific subset of NSCLC adenocarcinoma. Enzyme
 assays demonstrate that LP-300 inhibits human MET kinase activity and stimulates the inhibitory activity of staurosporine on human
 MET kinase.

 inhibits EGFR kinase activity. EGFR mutations are an important, specific subset of NSCLC adenocarcinoma, particularly in non-smoker
 females. Enzyme assays demonstrate that LP-300 inhibits EGFR kinase activity and potentiates the inhibitory effect of eErlotinib
 on wild type as well as mutant EGFR kinase activity.

 modestly inhibits retinal rod outer segment kinase (ROS1) activity. ROS1 chromosomal rearrangements are a recently identified
 class of mutations in NSCLC. Estimates of frequency of ROS1 rearrangements range from 1% to 2%. Experimental data are as follows:

 Enzyme
 activity data demonstrates that LP-300 has an effect on Human ROS1 activity when ROS1 is preincubated with LP-300. We hypothesize
 that pre-incubation allows slower reacting cysteine residues to be modulated by LP-300.

 Based
 on modeling studies, the cysteines on ROS1 appeared to be in less optimal orientations compared to cysteines in ALK.

 appears not to impact ROS1 activity unless ROS1 and LP-300 are pre-incubated prior to kinase assays. Therefore, to see an effect
 in vivo, it may be necessary to administer LP-300 prior to LP-300's effects on ROS1 through preincubation of ROS1 and
 LP-300, suggesting slower xenobiotic modulation reactions. However, there are several possible explanations for the LP-300 effect
 on ROS1 and in the absence of an X-ray structure this remains a hypothesis.

 modifies Ribonucleotide Reductase 1 and 2 (RNR1 and RNR2). Selective, elevated expression of the RNR1 subunit is associated with
 gemcitabine resistance in NSCLC. RNR1/RNR2 are essential for DNA synthesis, DNA repair & cell proliferation. RNR1/2 catalyzes
 the formation of deoxyribonucleotides needed for DNA synthesis, from ribonucleotides.

 targets proteins that may result in protection against chemotherapy-induced nephrotoxicity and neuropathy. The LP-300 derivative-cisplatin/paclitaxel
 conjugate is inactive and this conjugate is not a substrate for aminopeptidase/ -Glutamyl-transpeptidase (APN/GGT). These LP-300
 heteroconjugates appear to cause potent inhibition of APN/GGT leading to suppression/bypass of renal APN/GGT xenobiotic metabolism
 pathways promoting protection against chemotherapy-induced nephrotoxicity. In addition, binding of the LP-300 derivative with reactive
 cisplatin/paclitaxel species, appears to inactivate the platinum-catalyzed microtubule hyper-polymerization. This action may serve
 to protect against chemotherapy-induced peripheral neuropathy.

 modulates protein function in a way that may promote chemosensitization. LP-300 appears to promote covalent oxidation of redox
 proteins Thioredoxin (TRX), Peroxiredoxin1 (PRX1) and Glutaredoxin (GRX). This action may keep these redox proteins in an inactive
 non-signaling state, which could enhance sensitivity to oxidative stress and apoptosis induced by concomitant chemotherapy.

 Using
various in vitro experimental approaches, LP-300 has been observed to form adducts on cysteines of various protein targets such
as those listed below. For several of these targets, studies evaluating enzyme activity associated with the targets have demonstrated
inhibition, modulation or impairment of such activity. In addition, X-ray crystallographic studies support LP-300 derived adducts at
specific cysteines on these proteins.

 Targeted
Proteins Modified by LP-300

 Cellular
 Target of LP-300

 Cellular
 consequence of LP-300-modification and/or modulation

 Cellular
 thiol/disulfide balance

 and LP-300-derived mesna disulfide heteroconjugates are pharmacological surrogate/modulators of physiological thiols and disulfides
 (e.g., glutathione, cysteine, and homocysteine).

 Gamma-Glutamyltranspeptidase
 Aminopeptidase N

 and LP-300-derived mesna disulfide heteroconjugates can inhibit gamma-glutamyltranspeptidase and aminopeptidase N enzyme activity.

 Tubulin

 exerts direct and indirect protective interactions with tubulin.

 Anaplastic
 Lymphoma Kinase (ALK)

 disrupts/blocks ATP binding site resulting in inhibition of ALK kinase activity (vide infra).

 Mesenchymal
 Epithelial Transition (MET) Factor Kinase

 Modification
 of non-active site cysteine(s) resulting in enzyme inhibition (MET).

 ROS1
 kinase

 xenobiotically modifies ROS1 kinase in a time dependent manner.

 Redox
 Balance

 and LP-300-derived mesna disulfide heteroconjugates assist in the maintenance of cellular redox balance and support cellular defenses
 against oxidative insult.

 Thioredoxin
 (Trx) Glutaredoxin (Grx)

 modifies non-catalytic cysteines important in redox protein function/structure (Grx and Trx).

 Thioredoxin
 (Trx) Glutaredoxin (Grx)

 and/or LP-300-derived mesna disulfide heteroconjugates function as alternative substrates/inhibitors (Trx, Grx) resulting in impaired
 enzyme activity.

 Peroxiredoxin
 (Prx)

 disrupts active site structure (Prx) resulting in impaired enzyme activity.

 Mechanistic
evaluation of LP-300 revealed that it has cysteine-modifying activity on select Receptor Tyrosine Kinases (RTKs) initiating proliferative
signaling such as ALK, EGFR, MET and ROS1. LP-300 may also serve as a potential chemosensitizer for certain combination chemotherapies
by inactivating proteins such as Thioredoxin (TRX), Glutaredoxin (GRX) and Peroxiredoxin (PRX) that are important in modulating cellular
redox status and in turn drug resistance. Higher levels of PRX gene expression have been shown to correlate significantly with the absence
of smoking history and with the female gender.

 We
believe well-tolerated profile advantages of LP-300 are imparted through its chemoprotective action via production of inactive LP-300-chemotherapeutic
conjugates and preventing toxic taxane/platinum metabolites in the kidney, and targeting toxicity-inducing molecules and pathways (e.g.
APN, GGT, and Tubulin).

 Our
RADR Platform's Approach to LP-300 Repositioning

 Our
RADR platform has been implemented with the objective of uncovering insights from LP-300 rescued preclinical data as
well as from lung cancer clinical trial data regarding actionable bioinformatics, biomarkers, target population demographics and smoking
history. Differential expression analyses of RNAseq data on LP-300 pre- and post-exposure in selected NSCLC cell lines has revealed gene
sets that could be upregulated and downregulated in response to LP-300 treatments involving the mapping of genes performing cellular
redox functions, kinases involved in proliferating signaling, and apoptotic markers. We are currently in the early stages of defining
a specific biomarker signature that correlates with heightened sensitivity to LP-300. We believe that this signature may help accelerate
the clinical development of LP-300 and has the potential to guide patient selection for targeted clinical trials. We are also developing
a list of approved cancer drugs that, when used in combination with LP-300, may have potential to improve the overall benefit to patients
through either potentially greater anticancer properties or improved tolerability. We believe identifying such combinations would be
attractive to established pharmaceutical and biotech companies.

 Acquisition
of Tavocept (LP-300) Rights from BioNumerik

 In
January 2018, we entered into an Assignment Agreement (the "Assignment Agreement") with BioNumerik Pharmaceuticals, Inc.
("BioNumerik"), pursuant to which we acquired rights to domestic and international patents, trademarks and related technology
and data relating to LP-300 for human therapeutic treatment indications. Mr. Margrave, our Chief Financial Officer and Secretary, formerly
served as the President, Chief Administrative Officer, General Counsel and Secretary of BioNumerik and has a minority ownership interest
in BioNumerik. The Assignment Agreement replaced a License Agreement that was entered into between us and BioNumerik in May 2016. We
made upfront payments totaling $25,000 in connection with entry into the Assignment Agreement.

 If
we commercialize LP-300 internally, we will be required to pay to the BioNumerik-related payment recipients designated in the Assignment
Agreement a percentage royalty in the low double digits of cumulative net revenue up to $100 million, with incremental increases in the
percentage royalty for net cumulative revenue between $100 million and $250 million, $250 million and $500 million, and $500 million
and $1 billion, with a percentage royalty payment that could exceed $200 million for net cumulative revenue in excess of $1 billion.
In addition, we have the right to first recover certain designated portions of patent costs and development and regulatory costs before
the payment of royalties described above. We are obligated to make royalty payments under the Assignment Agreement during the "Agreement
Term " that started on January 5, 2018 and continues (on a country-by-country and product-by-product basis) until the later
to occur of (i) five (5) years after the expiration of the last to expire Patent Rights, as defined in the Assignment Agreement, in an
applicable country in the Territory, as defined in the Assignment Agreement, and (ii) if no Patent Rights exist in such country, fifteen
(15) years after May 31, 2016.

 If
we enter into a third party transaction for LP-300, we are required to pay the BioNumerik-related payment recipients a specified percentage
of any upfront, milestone, and royalty amounts received by us from the transaction, after first recovering specified direct costs incurred
by us for the development of LP-300 that are not otherwise reimbursed from such third party transaction. In addition, the Assignment
Agreement provides that we will use commercially diligent efforts to develop LP-300 and make specified regulatory filings and pay specified
development and regulatory costs related to LP-300. The Assignment Agreement also provides that we will provide TriviumVet DAC ("TriviumVet")
with (i) specified data and information generated by us with respect to LP-300, and (ii) an exclusive license to use specified LP-300-related
patent rights, trademark rights and related intellectual property to support LP-300 development in non-human (animal) treatment indications.
Under the Assignment Agreement, we are required to pay all patent costs on covered patents related to LP-300. These patent costs are
fully recoverable at the time of any net revenue from LP-300, with up to 50% of net revenue amounts to be applied towards repayment of
patent costs until such costs are fully recovered. In addition to the recovery of patent costs, we have the right to recover the $25,000
upfront payments made in connection with entry into the Assignment Agreement, which payments are recoverable prior to making any royalty
or third-party transaction sharing payments. We also have the right to recover all previously incurred LP-300 development and regulatory
costs, with up to a mid-single digit percentage of net revenue amounts to be applied towards repayment of development and regulatory
costs until such costs are fully recovered.

(hydroxyureamethylacylfulvene) is a small molecule that preferentially damages DNA in cancer cells that overexpress certain biomarkers
or that harbor mutations in DNA repair pathways. LP-184 is converted into an active alkylating agent by the enzyme prostaglandin reductase
1 (PTGR1), which is overexpressed in many tumor types that are resistant to current standard of care treatments. The FDA has granted
LP-184 Orphan Drug Designation for the treatment of pancreatic cancer, glioblastoma and ATRT ( A typical T eratoid R habdoid
 T umors). We believe cancer cells are less likely to develop resistance to LP-184 because of its mode of action that is independent
of efflux pumps and oncogene/tumor suppressor mutations. We also believe that LP-184 has the potential to address a significant unmet
need in the current treatment landscape for multiple important cancer types.

has nanomolar potency and it is a member of a new generation of acylfulvenes, a family of naturally-derived anticancer drug candidates.
Earlier generations of acylfulvenes showed great promise in preclinical studies, but were hampered in human clinical studies because
of the inability to deliver effective therapeutic doses due to unacceptable toxicities to normal cells. In preclinical studies, LP-184
has shown significantly enhanced antitumor activity as compared to earlier generation acylfulvenes. In addition, we have used our RADR
 platform, together with work of collaborators, to develop a patient-specific biomarker test we believe will be predictive of LP-184's
anticancer activity in targeted patient populations. The chemical structure of LP-184 is depicted below.

Chemical Structure

 Starlight
Therapeutics Inc. and STAR-001

 In
January 2023, we formed a wholly owned subsidiary, Starlight Therapeutics Inc. ("Starlight"), to develop drug candidate LP-184's
central nervous system (CNS) and brain cancer indications – including glioblastoma (GBM), brain metastases (brain mets.), and several
rare pediatric CNS cancers. Following the formation of Starlight, we now refer to the molecule LP-184, as it is developed in CNS indications,
as "STAR-001".

 Phase
1 Clinical Trial for LP-184

 We
are advancing LP-184 in a Phase 1 clinical trial focused on patients with advanced solid tumors and glioblastoma, which includes
potential patients with breast, lung, pancreatic, bladder, prostate, and ovarian cancers and other solid tumors. For the dose
escalation portion of the study, in addition to the primary objective of determining the MTD (maximum tolerated dose)/MAD (maximum
administered dose) and another dose for further clinical evaluation in Phase 1B, other objectives include correlations of clinical
activity with tumor expression of the gene PTGR1 (Prostaglandin Reductase 1) and/or genomic alterations in DNA damage repair pathway
genes. We expect to enroll approximately 60 patients in the Phase 1A portion of the study from multiple clinical trial sites. As of
the date of this report, we have 9 clinical trial sites that have been activated in the U.S. for the LP-184 Phase 1A
study.

 Upon
completion of enrollment in Phase 1A and analysis of safety, PK, and clinical activity data, we, together with the clinical investigators
participating in the study, will review the totality of study data to determine the recommended dose(s) to be used in further clinical
testing of LP-184 in Phase 1B. In anticipation of the planned commencement later this year of the Phase 1B portion of the LP-184 clinical
trial, we are currently evaluating the key components to be included in the protocol amendment to be filed in connection with the Phase
1B portion of the trial.

 Potential
Future LP-184 Clinical Studies

 The
following is a summary of potential future clinical studies of LP-184. The conduct of these studies will be subject to the evaluation
of data from the Phase 1a study and obtaining additional funding.

 Phase
1b/2 dose expansion study in adult patients with advanced triple negative breast cancer (TNBC), pancreatic cancer (PDAC), non small cell
lung cancer (NSCLC), and other solid tumors.

 We
plan to conduct a Phase 1b/2 dose expansion study of LP-184 in adult patients with advanced triple negative breast cancer (TNBC), pancreatic
cancer (PDAC), non small cell lung cancer (NSCLC), and other solid tumors. Our objective for the planned conduct of this study will be
to provide safety and potential preliminary efficacy data, and to inform the optimal dose of LP-184 monotherapy that can be administered
in the treatment of a subset of advanced solid tumors with known DNA Damage Repair (DDR) pathways. The Phase 1b portion of the study
is expected to be a multi-center study with the primary objective of determining the recommended Phase 2 dose (RP2D) of LP-184 in TNBC
and other indications, including NSCLC, PDAC, and other solid tumors.

 It
 is estimated that approximately 30% of solid tumors (including ovarian, breast, pancreatic,
 colon, and prostate cancers, as well as melanoma and leiomyosarcoma) harbor alterations in
 DDR pathways. DNA repair targeting therapies exploit DDR alterations in cancer cells to achieve
 synthetic lethality, a therapeutic rationale that has led to the development of a variety
 of DDR inhibitors, such as PARP inhibitors. Although DDR inhibitors that are approved or
 under development have shown promising clinical activity, approximately 40-70% of patients
 develop resistance over time and necessitate additional therapies.

 is a synthetically lethal small molecule that in preclinical studies has been observed to
 induce DNA double strand breaks upon bioactivation by the enzyme prostaglandin reductase
 1 (PTGR1) in cancer cells. In preclinical studies, LP-184 showed a high degree of anti-tumor
 activity in triple-negative breast cancer (TNBC), pancreatic ductal adenocarcinoma (PDAC),
 non-small cell lung cancer (NSCLC) and other solid tumors. Preclinical studies and artificial
 intelligence-driven in silico modeling suggest that cancers with DNA Damage Response
 (DDR) gene alterations may preferentially respond to LP-184.

 Phase
1b/2 Study of LP-184 in combination with olaparib in adult patients with Advanced HR-Negative and HER2-Negative Breast Cancer (Triple-Negative
Breast Cancer; TNBC).

 We
plan to conduct a Phase 1b/2 Study of LP-184 in combination with olaparib in adult patients with Advanced HR-Negative and HER2-Negative
Breast Cancer (Triple-Negative Breast Cancer; TNBC). Our objective for the planned conduct of this study will be to provide safety and
potential preliminary efficacy data, to inform the optimal dose(s) of LP-184 that can be administered in a specified dosing regimen,
in combination with olaparib, in future pivotal clinical studies. This is expected to be a multicenter study with the primary objective
of evaluating the safety, tolerability, and preliminary estimates of clinical activity of LP-184 in combination with olaparib in patients
with HR-negative and HER2-negative breast cancer patients (TNBC).

 TNBC
 accounts for approximately 15% of breast cancers and presents with the worst prognosis. It
 does not benefit from targeted treatment and hormonal treatment options for breast cancer.
 TNBC is a heterogeneous disease with a high frequency of homologous recombination deficiency
 (HRD). Despite advances made in the development of therapies for TNBC, overall survival remains
 poor and strategies to overcome resistance to approved therapies, including approved PARP
 inhibitors like olaparib, are needed.

 In
 vitro, LP-184 has demonstrated inhibitory activity (with sub micromolar IC50 values) in multiple
 TNBC breast cancer cell lines. In vivo, in TNBC PDX models, LP-184 showed 107 – 132%
 tumor growth inhibition with complete tumor regression observed, especially in models harboring
 HRD and irrespective of their sensitivity to PARP inhibitors. In addition, the combination
 of LP-184 with olaparib resulted in synergistic tumor growth inhibition in TNBC PDX models
 when compared to either monotherapy.

 Phase
1b/2 Study of LP-184 in combination with nivolumab and ipilimumab in KEAP1 and/or STK11-mutated and PD-L1-low non-small cell lung cancer
(NSCLC).

 We
plan to conduct a Phase 1b/2 Study of LP-184 in combination with nivolumab and ipilimumab in KEAP1 and/or STK11 -mutated
and PD-L1-low non-small cell lung cancer (NSCLC). Our objective for the planned conduct of this study will be to provide safety and potential
preliminary efficacy data, and to inform the optimal dose(s) and regimen of LP-184 that can be administered in combination with the standard
of care nivolumab and ipilimumab immunotherapy regimen. This is expected to be a multicenter study with the primary objective of evaluating
the safety tolerability, and preliminary estimates of clinical activity of LP-184 in combination with standard of care immunotherapy
treatment in patients with KEAP1 and/or STK11 -mutated and PD-L1-low non-small cell lung cancer (NSCLC).

 Lung
 cancer is the most frequent cause of cancer-related death worldwide with NSCLC being the
 most common type, and accounting for approximately 85% of lung cancers. Despite the progress
 made in the last decade with immunotherapy, targeted therapy, and other treatments, there
 is still a significant unmet need for effective therapies for NSCLC patients. Specifically,
 alterations in the KEAP1 and STK11 genes are common in NSCLC patients and often
 associated with worse prognosis. Most KEAP1 and/or STK11 mutated NSCLC patients
 have no or low PD-L1 expression, further limiting the benefits from PD-(L)1 blockage therapies.
 There is a high unmet need for effective therapies for NSCLC patients harboring the above
 alterations, which have often been considered undruggable and/or associated with mechanisms
 of resistance to approved therapies.

 We
 believe LP-184 has the potential to improve outcomes in the KEAP1 and/or STK11
 mutated NSCLC subset of patients. In the H460 ( KEAP1 and STK11 double mutant)
 human NSCLC cell line derived xenograft tumor model, LP-184 single agent demonstrated 102%
 tumor growth inhibition (TGI). We also believe that LP-184 holds potential promise for boosting
 the efficacy of immune checkpoint inhibitors (ICIs), likely via reprogramming the tumor microenvironment.
 In preclinical studies, we have observed that, when combined with ICIs, LP-184 has the capacity
 to produce a synergistic anti-tumor response by amplifying DNA damage, reducing immunosuppression
 and targeting vulnerabilities underlying KEAP1 and/or STK11 mutations thereby
 also helping to reverse ICI resistance. In a proof-of-concept study in mouse triple-negative
 breast cancer tumor models that were non-hypermutated and ICI resistant, LP-184 combined
 with an anti-PD-1 agent synergized and elicited a greater anti-tumor response than monotherapies.
 The LP-184 and anti-PD-1 combination also enhanced antigen presentation and interferon signaling
 in these models.

LP-184 (STAR-001) Development Opportunities – Starlight Therapeutics Inc.

in Glioblastoma and other CNS Cancers

is an aggressive type of cancer that begins in the brain and accounts for more than half of all brain cancers. Glioblastoma has an overall
five-year survival rate of 5%, meaning that only approximately 5 in 100 people survive GBM for five years and beyond. We believe that
STAR-001's molecular features and distinct mechanism of action, preclinical anti-tumor activity and strong correlation with specific
biomarkers have the potential to provide a unique and powerful approach aimed at addressing high unmet needs in GBM and other aggressive
CNS tumors.

 Data
and observations supporting the development of STAR-001 for GBM and other brain cancers include the following:

 We
 have obtained favorable preclinical in vivo and in vitro data supporting the ability of STAR-001 to cross the blood brain barrier.

 treatment induced tumor regression evidenced by greater than 106% tumor growth inhibition in two subcutaneous xenograft models of
 GBM (U87 and M1123). STAR-001 also prolonged survival in mice bearing an intracranially implanted tumor model of GBM (U87), as compared
 with those that did not receive any drug substance.

 Intravenous
 administration of STAR-001 over two cycles reduced subcutaneous xenograft tumor volume in mice by greater than 85% within the treatment
 group.

 In
 an orthotopic GBM xenograft tumor model in mice, a single cycle of STAR-001 resulted in a statistically significant (p < 0.0001)
 extension of median overall survival in the STAR-001-treated group (42 days) versus the control group (33 days).

 Analyses
 driven by RADR have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects
 in DNA damage repair components as a targeted subset of genetically defined patients who could potentially benefit from STAR-001-based
 therapy.

 data supports the observation that STAR-001 has potential to be an effective treatment in GBM regardless of MGMT (a DNA repair enzyme) status
 of the cancer. This has significant potential to provide a much-needed alternative to the standard-of-care drug, temozolomide (TMZ),
 especially in GBMs that over-express MGMT — which can be up to 50% of GBM cancers.

 In
 August 2021, the FDA granted STAR-001 Orphan Drug Designation for the treatment of GBM and other malignant gliomas.

 The
standard treatment for glioblastoma includes radiation and chemotherapy with temozolomide. Based on an article in the journal Genes and
Diseases ( Temozolomide resistance in glioblastoma multiforme, Genes Dis., 2016 May 11;3(3):198-210) and other publications, at
least fifty percent of temozolomide treated patients do not respond to this treatment, and others often form resistance to temozolomide
based regimens. We have obtained preclinical data supporting the observation that STAR-001 has potential to be an effective treatment in GBM regardless
of the MGMT (a DNA repair enzyme) status of the cancer. This has significant potential to provide a much-needed alternative to the standard-of-care
drug, temozolomide (TMZ), especially in GBMs that over-express MGMT — which can be up to 50% of GBM cancers. Patients that have
GBMs that over-express MGMT are generally unresponsive to TMZ and need new therapy options that can exploit other molecular pathways
and mechanisms.

 We
believe STAR-001's ability to cross the blood-brain barrier, together with its preclinical anti-tumor activity and sensitivity
correlations with relevant biomarkers, highlight STAR-001's potential for use as both monotherapy as well as a synergistic agent
in combination with other drugs to address the unmet needs in GBM and other aggressive central nervous system tumors.

 Potential
Future STAR-001 Clinical Studies

 The
following is a summary of potential future clinical studies of STAR-001. The conduct of these studies will be subject to the evaluation
of data from the LP-184 Phase 1a study and obtaining additional funding.

 A
Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 (LP-184) in combination with Spironolactone
in IDH wild type Supratentorial Glioblastoma at First Progression

 In
preclinical tumor models, co-treatment with Spironolactone (SP), a transcription-coupled nucleotide excision repair (TC-NER) inhibitor,
sensitized GBM cells and xenografts to STAR-001. SP is an FDA approved blood-brain barrier (BBB) permeable aldosterone antagonist that
inhibits TC-NER by inducing ubiquitin-mediated proteolytic degradation of ERCC3. SP and its active metabolites are specific pharmacologic
antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange
site in the distal convoluted renal tubule. SP acts both as a diuretic and as an antihypertensive drug by this mechanism. SP is commonly
used for the treatment of heart failure, hypertension, and complications of cirrhosis by antagonizing the mineralocorticoid receptor.

 The
objective for the planned conduct of this study will be to evaluate the safety and tolerability of STAR-001 when administered with spironolactone
in subjects with recurrent IDH wild type glioblastoma. The trial will also evaluate the pharmacokinetics of STAR-001 with spironolactone
in subjects and the preliminary anti-tumor activity in combination with spironolactone. Additional measures of anti-cancer activity,
including duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival are also expected
to be evaluated.

in ATRT and Pediatric Rare Disease Designation

 ATRTs
( A typical T eratoid R habdoid T umors) are rare neurological tumors that primarily affect children under the
age of three. These clinically aggressive tumors are associated with a very poor prognosis, including a median survival of 6-12 months
and a 5 year survival rate of 30%. The National Cancer Institute (NCI) estimates that in the U.S. there are 600 living ATRT patients
with 60 new patients diagnosed annually. These tumors are typically pathogenetically driven by loss of function of the SMARCB1 or SMARCA4
genes. We believe that STAR-001's molecular features and distinct mechanism of action, observed preclinical anti-tumor activity
and correlation with specific biomarkers have the potential to provide a unique and powerful approach aimed at addressing unmet needs
for this ultrarare pediatric cancer. We plan to pursue further preclinical studies of STAR-001 in this indication.

 Data
and Observations supporting the development of STAR-001 for ATRT include the following:

 We
 have obtained favorable preclinical in vivo and in vitro data supporting the ability of STAR-001 to cross the blood brain barrier.

 was observed to have a potent activity in ATRT cell lines CHLA-02, CHLA-05, and CHLA-06 with IC50s (nM) of 1776, 162, and 37.4, respectively.

 In
 ATRT xenograft tumor models in mice, i.v. injections of STAR-001 at either 2 mg/kg or 4 mg/kg had high in vivo activity. At both
 concentrations xenografts showed complete tumor regression compared to the vehicle control group.

 in vivo and in vitro data supports the in-silico observation that STAR-001 can be an effective treatment for ATRT. Currently, there
 is no standard of care for treatment of children with ATRT.

 has been granted Orphan Drug Designation and Rare Pediatric Disease Designation to treat ATRT.

 The
FDA grants rare pediatric disease designation for serious and life-threatening diseases that primarily affect children ages 18 years
or younger and fewer than 200,000 people in the United States. The Rare Pediatric Disease Priority Review Voucher Program is intended
to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program,
companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if
the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless
changed by legislation. If issued, a sponsor may redeem a priority review voucher for priority review of a subsequent marketing application
for a different product candidate, or the priority review voucher could be sold or transferred to another sponsor.

 Potential
Future STAR-001 Pediatric Clinical Studies

 The
following is a summary of potential future pediatric clinical studies of STAR-001. The conduct of these studies will be subject to the
evaluation of data from the LP-184 Phase 1a study and obtaining additional funding.

 A
Phase 1, Multicenter, Open-Label, Dose Escalation Study of STAR-001 as a Single Agent and in Combination with Spironolactone in Pediatric
Patients with Relapsed or Refractory Central Nervous System Malignancies

 Pediatric
central nervous system (CNS) tumors are the second most common cancer in childhood and the leading cause of childhood death from cancer.
Children and young adults with relapsed or refractory malignant CNS tumors have a dismal prognosis, and outcomes remain very poor. While
many children with CNS malignancies can be cured from multimodal treatment including surgery, radiation, and chemotherapy those with
relapsed or refractory disease post radiation typically do not have curative therapy. Additionally, those children who survive their
brain cancer diagnosis often have significant morbidity from their tumor, hydrocephalus, surgery, or treatment. Thus, novel treatments
are needed in this patient population to improve outcomes in survival and quality of life after treatment.

 The
objective for Part 1 of the planned conduct of this study will be to evaluate the safety, tolerability, MTD and the RP2D of STAR-001
in pediatric patients with relapsed/refractory CNS malignancies who have failed standard therapy or for whom no standard therapy is available.
Part 2 of this planned study is expected to evaluate the safety and tolerability of STAR-001 in combination with spironolactone at the
MTD established in Part 1, in pediatric patients with relapsed/refractory CNS malignancies who have failed standard therapy or for whom
no standard therapy is available.

in Triple Negative Breast Cancer:

 Triple
negative breast cancers (TNBCs) represent approximately 24% of newly diagnosed breast cancers. The median overall survival (mOS) for
TNBC is: 11.6 months after the first line of treatment; 6.5 months after the second line of treatment; and 6.5 months after the third
line of treatment. The mOS for de novo metastatic TNBC is 8.3 months, while the mOS for those with a relapse within 18 months of primary
diagnosis is 10.0 months.

in Pancreatic Cancer

cancer is the 3rd leading cause of cancer death in the U.S. Despite rigorous highly cytotoxic therapies and a few approved targeted therapies,
the 5 year overall survival for advanced pancreatic cancer is approximately 3%, leaving a large number of patients with no additional
treatment options. LP-184 has demonstrated significant potency in multiple preclinical studies focused on pancreatic cancer, and we are
positioning LP-184 for areas of high unmet need in genetically targeted pancreatic cancers.

 Data
and observations supporting the development of LP-184 for pancreatic cancer include the following:

 We
 believe LP-184 acts by selectively damaging DNA in tumors that express high levels of the enzyme PTGR1 – which occurs in several
 solid tumors. Analysis with our data platform, RADR, indicates that 35-40% of pancreatic tumors overexpress PTGR1.

 studies have shown significant and targeted anti-tumor effects of LP-184, even in pancreatic cancers that are resistant to standard-of-care
 drugs.

 tumors with DNA-damage repair deficiencies were significantly more sensitive (by two times) to LP-184 in preclinical studies. This
 and other observations support LP-184's potential as a synthetic lethal agent in many HRD (homologous recombination deficient)
 and NERD (nucleotide excision repair deficient) cancers.

 LP-184,
 demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, in in-vivo mouse models in 8 weeks. In comparison,
 the tumors in the untreated mice grew by over eleven-fold in volume during the same 8 week period.

 positive preclinical data on the anti-cancer activity and potency of LP-184 was gathered from 6 pancreatic cancer cell lines, and
 an additional 5 patient-derived xenograft (PDX) ex-vivo tumor models. Significant reduction of cancer cells and cancer cell
 growth was observed across all pancreatic cancer cell lines and PDX models that were tested in the study with IC50 values in the
 nanomolar range (45-270 nM).

 Our
 A.I. based identification of the key gene in the drug mechanism-of-action for LP-184 was validated by leveraging gene-editing (CRISPR)
 technology to validate PTGR1 as a fundamental driver of tumor sensitivity and cancer cell death.

 treatment of 2 PDX models for HR deficient pancreatic cancer in preclinical studies resulted in 110-140% tumor growth inhibition.

 In
 August 2021, the FDA granted LP-184 Orphan Drug Designation for the treatment of pancreatic cancer.

LP-184 Background

 We
have evaluated LP-184 in a number of solid tumors that overexpress certain biomarkers that have been identified as correlating with potential
response to LP-184. Our analysis indicates that LP-184 is expected to be a pro-drug activated by the enzyme Prostaglandin Reductase 1
("PTGR1"). We believe LP-184's mechanism of action is to alkylate DNA and protein macromolecules, form adducts, and
arrest cells in the S-phase of the cell cycle.

 Using
our RADR platform, we have derived a 10-gene signature composed of candidate biomarkers determining sensitivity to LP-184.
Genes from this signature, such as PTGR1, were found to be implicated in the potential induction of bioactivation of LP-184. We believe
LP-184 may be well positioned as a new drug candidate for individual patient genetic profiles identified as having DNA repair complex
deficiencies or other commonly prevalent gene signatures. LP-184 displayed less bone marrow toxicity in preclinical studies (dog and
mouse), had an improved pharmacokinetic profile (increased bioavailability as reflected by increased AUC), was stable in plasma, and
had an increased shelf life or stability in pharmaceutical grade material (sterile glass containers) for its class of compounds. LP-184
retained selective cytotoxicity towards solid tumor derived cell lines in vitro.

 We
believe LP-184 is a non-hormone, next generation alkylating agent with nanomolar potency that preferentially damages DNA in cancer cells
that overexpress certain biomarkers indicated primarily in solid tumors such as those in prostate, pancreatic and ovarian cancers. LP-184
was developed using combinatorial chemistry approaches. Based on screening against conventional therapies both in vitro and in
vivo, LP-184 cytotoxicity appears to be mediated through the Transcription Coupled Nucleotide Excision Repair (TC-NER) pathway, via
alkylation of DNA leading to cell cycle arrest in S phase. Additional cytotoxic effects on tumors may include the generation of reactive
oxygen species, chemical modification of various intracellular proteins, and induction of the Mitogen Activated Protein Kinase ("MAPK")
pathway followed by apoptosis. A proposed model for the mechanism of action of LP-184 is illustrated below.

 Working
Model for LP-148 Mechanism of Action

 Our
RADR platform has identified multiple solid tumor cancer indications that highly express PTGR1, including prostate, ovarian,
kidney, liver, lung, pancreatic and thyroid cancers. Our RADR platform has and will be employed to correlate results
from ongoing preclinical studies with gene expression data with the aim of determining the likely anticancer activity of LP-184 in these
cancer indications. With the assistance of insights from RADR, we have also conducted studies in patient derived xenografts
(PDX) models to further elucidate precise targets and potential patient groups for future LP-184 clinical trials.

 Use
of RADR in LP-184 Development

 Using
our RADR platform, we matched LP-184 drug response data in cell lines and in ex vivo PDX models with gene expression
from matched RNA-seq experiments in over 100 samples to build models that predict LP-184 response using a small number of gene expression
values. (See Figure A below) The machine learning model was able to accurately predict LP-184 response. (See Figure B below) The final
model required only 10 genes - as opposed to the entire transcriptome - to make predictions, with PTGR1 making a dominant contribution.
This suggests PTGR1 is required for activity or has a strong effect to enhance drug sensitivity. (See Figure C below)

 To
test this hypothesis, PTGR1 was knocked down with a CRISPR-interference construct that ablated PTGR1 expression, and consequently,
LP-184 sensitivity was lost. (See Figure C below) Because the LP-184 model can predict drug response with any RNA data, we surveyed public
RNA-seq data to support targeted cancer indications of interest for LP-184. (See Figure D below)

 We
observed that Atypical Teratoid Rhabdoid Tumor (ATRT) was predicted to be highly responsive to LP-184, and the presence of its characteristic
SWI/SNF-complex mutations in SMARCB1 or SMARCA4 were associated with lower predicted IC50 values. (See Figure E below)
We performed mouse xenografts with an ATRT line and validated extreme responsivity to LP-184 that was previously predicted by RADR. This
demonstrates RADR ability to make valid drug response model predictions based on gene expression, which can be used
to optimize drug positioning, uncover drug mechanism-of-action, and discover relevant biomarkers.

 Disease
Background for Pancreatic Cancer, Glioblastoma, Triple Negative Breast Cancer, Atypical Teratoid Rhabdoid Tumors (ATRT), and Prostate

 Initial
target patient populations for LP-184 include pancreatic cancer, glioblastoma, triple negative breast cancer, atypical teratoid rhabdoid
tumors (ATRT) and prostate cancer.

cancer is the third leading cause of cancer deaths in the United States with a five-year survival rate of 12.8%. This means that only
approximately 13 in 100 people will have survived for five years and beyond. Pancreatic cancer has among the lowest 5-year survival rate
of any of the 22 common cancers. Global Cancer Statistics 2022 estimates that for pancreatic cancer there are approximately 510,566 new
cases of pancreatic cancer globally.

 The
American Cancer Society's estimates for pancreatic cancer in the United States for 2025 are:

 About
 67,440 people (34,950 men and 32,490 women) will be diagnosed with pancreatic cancer; and

 About
 51,980 people (27,050 men and 24,930 women) will die of pancreatic cancer.

 Targeting
a specific subset of pancreatic cancer patients that are genetically defined has the potential to increase beneficial therapeutic options
for patients and may ultimately improve survival for those with this cancer.

is a fast-growing, aggressive type of CNS (Central Nervous System) tumor that forms on the supportive tissue of the brain. Glioblastoma
is the most common high grade glioma (HGG). The American Cancer Society estimates that approximately 25,820 malignant tumors of the brain
or spinal cord (14,040 in males and 10,780 in females) will occur in the U.S. in 2025. It also estimates that in 2025, approximately
18,330 deaths will occur from brain and other nervous system cancers. Approximately 250,000 new glioblastoma cases are estimated to occur
each year worldwide, with approximately 11,000 to 13,000 new glioblastoma cases estimated to occur each year in the U.S. Glioblastomas
usually affect adults. Treating glioblastoma is very difficult due to the brain-blood barrier and treatment often focuses primarily on
relieving symptoms.

 Triple-Negative
Breast Cancer

 Triple-negative
breast cancer (TNBC) accounts for about 15% of all breast cancers. TNBCs lack three hormone receptors that usually exist in healthy breast
cells: estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2). As such, hormone therapy
and medicines that target HER2 protein receptors are not effective against this type of cancer. Triple negative breast cancer is also
more aggressive and has a higher grade than other breast cancers. TNBC is the subtype of breast cancer with the highest rates of recurrence
and mortality.

 The
5-year survival rate for TNBC is set forth below, categorized by the stage of the cancer:

 Local
 or Stage 0–Stage 1: 91%

 Regional
 or Stage II–Stage III: 66%

 Distant
 or Stage IV: 12%

 ATRT

 Atypical
Teratoid Rhabdoid Tumors (ATRT) are rare, rapidly progressing, and malignant pediatric tumors of the central nervous system and are primarily
found in children under the age of three. The National Cancer Institute estimates there are 73 cases of ATRT diagnosed per year and 470
patients currently living with ATRTs, of which only 10% are in adults 20 years or older. Patients with ATRTs have a very poor prognosis
including a median survival of approximately 12 months and a 5 year overall survival of approximately 30%. ATRTs are difficult to treat
due to the very rapid onset of these tumors as well as a requirement for therapies that can penetrate the blood-brain barrier. The U.S.
is expected to capture the majority share of the ATRT market with ~65%.

 Prostate

 Prostate
cancer is the most commonly diagnosed cancer in men in the US and the second leading cause of cancer-related death in men in the US.
The American Cancer Society's estimates for prostate cancer in the United States for 2025 are:

 313,780 new cases of prostate cancer

 35,770 deaths from prostate cancer

50% of patients who die from prostate cancer have metastases at diagnosis. The survival gains over the last decade have been modest with
acceleration in life-extending drug development occurring in the last three years. Hormonal therapy works to reduce testosterone levels
in the body to a level equal to that seen if physical castration were to occur. However, hormonal therapy can become refractory after
one to three years and tumor growth may resume. This is referred to as Castration-Resistant Prostate Cancer ("CRPC"). About
10 - 20 % of prostate cancer patients develop CRPC within five years. Typically, standard hormonal therapy involving Androgen Deprivation
Therapy (ADT) was prescribed in the past for all comer patients. Current prescribed regimens involve intensified therapy for most patients
(docetaxel for high volume disease, and Zytiga for low and high volume disease) whereas upcoming molecularly selected agents in addition
to hormonal therapy are used in an individualized approach to metastasis-directed or local therapy. Standard of care agents for prostate
cancer include without limitation (i) Androgen production suppressors, such as Leuprolide (Lupron, Eligard), Goserelin (Zoladex), Triptorelin
(Trelstar), Histrelin (Vantas), Abiraterone (Zytiga), (ii) Androgen signaling blockers, such as Flutamide (Eulexin), Bicalutamide (Casodex),
Nilutamide (Nilandron), and Enzalutamide (Xtandi), and (iii) chemotherapeutics such as docetaxel and cabazitaxel. In 2022 Pluvicto (active
ingredient lutetium Lu 177 vipivotide tetraxetan) was approved by FDA for the treatment of prostate-specific membrane antigen (PSMA)
positive mCRPC. In 2023, FDA approved Akeega (fixed dose combination of niraparib and abiraterone acetate) with prednisone, targeting
adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC). Drug classes of new
small molecules in development include PARP inhibitors, PI3K inhibitors and DNA Damage Repair (DDR) inhibitors. The PARP inhibitors olaparib
(Lynparza) and rucaparib (Rubraca) and the PD1 inhibitor pembrolizumab (Keytruda) have been approved by the FDA for a subset of the patient
population. The identification and characterization of new molecular targets, agents exploiting new or non-parallel mechanisms of action,
and the discovery of predictive biomarkers for mCRPC, are three of the major unmet needs in the prostate cancer space in the era of precision
medicine that we believe LP-184 may address.

Opportunity for LP-184

 We
are targeting a set of indications for LP-184 based on combining the factors of predicted response, unmet clinical need and market
opportunity. These include triple negative breast cancer, pancreatic cancer, glioblastoma, prostate cancer, and ATRTs. Below is an
overview of relevant patient numbers and estimated market sizes of some of the indications that we believe LP-184 may potentially
address, if approved, based upon published estimates by the Global Cancer Observatory and other published sources:

 Triple
Negative Breast Cancer:

 TNBCs
represent approximately 24% of newly diagnosed breast cancers. The median overall survival (mOS) for TNBC is: 11.6 months after the first
line of treatment; 6.5 months after the second line of treatment; and 6.5 months after the third line of treatment. The mOS for de novo
metastatic TNBC is 8.3 months, while the mOS for those with a relapse within 18 months of primary diagnosis is 10.0 months.

 Pancreatic cancer

 Global
 (2022)

 US
 (2025)

 Pancreatic cancer cases

 510,566

 67,440

 Advanced pancreatic cancer cases (80% of all pancreatic cancer)

 408,453

 53,952

 85% of advanced pancreatic cases are treated in 1 st line setting

 347,185

 45,860

 60% of advanced pancreatic cases treated in 1 st line are treated in 2 nd line

 208,311

 27,516

 30% of advanced pancreatic cases treated 2 nd line are treated in 3 rd line

 62,494

 8,255

 Potential patient percentage in initial targeted segment

 12.2
 %

 12.2
 %

 Global

 US

 Total glioblastoma (GBM) estimated incidence

 250,000

 13,000

 Number of newly diagnosed GBM patients treated (treatment rate 76.6%)

 191,500

 9,958

 Number of newly diagnosed MGMT unmethylated GBM patients

 126,390

 6,572

 Potential patient percentage in initial targeted segment

 50.5
 %

 50.5
 %

 Recurrent patients treated in 1 st line (69% newly diagnosed patients received 1L)

 132,135

 6,872

 Recurrent patients progressing to 2L treatment (70.3% recurred patients receive 2L)

 92,890

 4,831

 Prostate cancer

 Global
 (2022)

 US
 (2025)

 Total prostate cancer estimated incidence (new cases)

 1,466,680

 313,780

 CRPC incidence, ~20% of all prostate cancer

 293,336

 62,756

 Metastatic CRPC incidence, ~80% of newly diagnosed CRPC

 234,669

 50,205

 Potential patient percentage in initial targeted segment

 %

 %

 Strategic
Academic Collaborations for LP-184

 We
are or have been involved in the following academic collaborations for LP-184:

 The
 Research Institute of Fox Chase Cancer Center ("FCCC"). Our collaboration with FCCC has yielded results that
 strongly link LP-184 anti-tumor activity to the expression of PTGR1. PTGR1 was identified by our RADR analysis as the lead gene
 candidate, the expression of which is essential to LP-184 mediated cytotoxicity. Using CRISPR engineered cells, we demonstrated a
 total lack of activity in tumor cell lines where PTGR1 expression is artificially knocked out. These data continue to support our
 RADR based predictions and the strategies of using LP-184 for tumor indications based upon PTGR1 expression. Our RADR analysis has
 identified a multitude of tumors with a higher than required threshold of PTGR1 expression. We have further validated the activity
 of LP-184 in a panel of pancreatic cancer cell lines. We have also conducted studies to evaluate the anti-tumor activity of LP-184
 in pancreatic cancer PDX models and in xenografts. Additional wet lab studies have been conducted with the aim of further validating
 RADR defined combinations with standard of care drugs in order to identify optimal synergistic drugs that could be eventually used
 in potential treatments with LP-184.

 Kennedy
 Krieger Institute and the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. We have collaborated with Kennedy
 Krieger Institute and investigators at the Johns Hopkins School of Medicine. We sought this collaboration following multiple unique
 findings regarding LP-184, including: the preclinical anti-tumor activity of LP-184 in glioblastoma (GBM); a positive result suggesting
 the ability of LP-184 to penetrate the Blood Brain Barrier, in amounts similar to the GBM standard of care agent Temozolomide (TMZ);
 and LP-184's special ability to kill GBM cells irrespective of the methylation status of MGMT promoter. We believe there is
 an urgent unmet need for an effective therapy to treat GBM with unmethylated MGMT. Both wet lab data and RADR based gene correlations
 highlighted sensitivity of tumor cells that carry unmethylated MGMT to LP-184. We have obtained additional data in an expanded panel
 of GBM tumor cell lines, neurospheres obtained from patient biopsies and evaluation of LP-184 in GBM xenografts. Results from this
 collaboration support the promise of LP-184 (STAR-001) for GBM.

 Georgetown
 University. In the first phase of our collaboration with Georgetown University, we confirmed the preclinical anti-tumor activity
 of LP-184 in a panel of prostate cancer organoid models. In the second phase, we focused on wet lab validation of the leads
 generated by our A.I. models of the gene dependency of most sensitive prostate cancers. This project aimed at providing experimental
 data to support use of LP-184 in a personalized medicine approach to treating prostate cancer. Our gene correlation data has highlighted
 the deficiency of several pathways that hypothetically would allow LP-184 to be synthetically lethal in tumors with such
 disruptions. Our RADR analysis also indicates that as many as 20% of prostate cancers carry markers that will make these tumors
 highly sensitive to LP1-84. In Phase 2 or our collaboration with Georgetown, we focused on the development of gene specific
 isogenic engineered prostate cancer cell lines to dissect the pathways as well as extend the 2D and 3D prostate cancer studies to in
 vivo genomically defined prostate cancer PDXs. In addition, we designed studies to test LP-184 in combination with
 several other drugs that are known to inhibit pathways needed to repair damage to DNA caused by LP-184. The potential advantage of
 combining our DNA damaging agent along with a DNA damage repair inhibitor is that it is expected to substantially extend the tumor
 specific anti-tumor activity of LP-184, including prostate cancers that might otherwise not carry deficiencies in the DNA repair
 pathway.

 The
Danish Cancer Society-Research Center. In January of 2022 we entered a research collaboration with the Danish Cancer Society Research
Center (DCRC). The collaboration focused on examining the most common solid tumors in order to determine the patient populations most
likely to benefit from our drug candidates LP-100 (irofulven) and LP-184. LP-100 and LP-184 have both been shown to have a synthetically
lethal impact in tumors that are lacking nucleotide excision repair (NER) capabilities. An additional aim of this collaboration was to
help develop improved diagnostic tools to detect NER deficient patient profiles more accurately. The collaboration included a focus on
the role of NER deficiency in breast, ovarian, prostate, lung, kidney, bladder, stomach, pancreatic, and esophageal cancers. The data,
genomic signatures, and biological models generated from the collaboration have added to the oncology focused RADR data
points.

 The
 Greehey Children's Cancer Research Institute (GCCRI) at the University of Texas Health Science Center-San Antonio. In
 February 2022, we announced a research collaboration with the Greehey Children's Cancer Research Institute (GCCRI) at the
 University of Texas Health Science Center-San Antonio. The GCCRI research collaboration focused on the effectiveness of LP-184 and
 LP-284 in genomically-defined pediatric cancers, including several without any effective therapeutic approach. The collaboration
 leveraged GCCRI's pediatric tumor research models and knowledge base to advance LP-184 for the potential treatment of rare
 pediatric cancers including rhabdomyosarcoma, Ewing sarcoma, MRT (malignant rhabdoid tumor), Wilms tumor, and ATRT (atypical
 teratoid rhabdoid tumor). Dr. Peter Houghton Ph. D. led the collaboration for the GCCRI and is widely regarded as leading
 expert on pediatric cancer research and in the development of novel approaches to treating childhood cancers. An integral component
 of Dr. Houghton's research success has been the development and use of Patient-Derived Xenografts (PDX), which are clinically
 relevant cancer models that allow researchers to test novel therapeutics - such as LP-184 - in-vivo, and to directly study how
 tumors respond to treatment.

 Pre-IND
Enabling Animal Studies

 We
conducted IND enabling studies in rats and Beagle dogs to provide supporting information regarding safety profile and selection of the
starting dose in humans in connection with the IND application for LP-184. These studies included (i) non-GLP dose range finding in rats,
(ii) GLP analysis of toxicity in rats, (iii) non-GLP dose range finding in dogs, (iv) GLP analysis of toxicity in dogs, (v) analytical
method development for the determination of LP-184 levels in rat and dog plasma, (vi) analytical method validation, and (vii) pharmacokinetic
profiling of LP-184 in the plasma of dosed rats and dogs.

Chemical Structure

is a novel small molecule and DNA damaging agent being developed by Lantern for the treatment of several non-Hodgkin's lymphomas
(NHL) including mantle cell lymphoma (MCL)
and double hit lymphoma (DHL). LP-284 belongs to the new generation of acylfulvenes, a family of naturally derived anti-cancer
drug candidates and is the stereoisomer (enantiomer) of our drug candidate LP-184. In comparison to LP-184, LP-284 has distinct anti-tumor
activities in a variety of hematological cancers including lymphoma, multiple myeloma, and leukemia. LP-284 has the potential to be developed
as a monotherapy or combination therapy with other drugs to treat a broad array of hematological cancers. The FDA has granted LP-284
Orphan Drug Designation for the treatment of mantle cell lymphoma, based on LP-284's demonstrated anti-tumor activity across a
comprehensive number of in vitro and in vivo models of MCL. In addition, the FDA has granted a
second LP-284 Orphan Drug Designation for the treatment of high-grade B-cell lymphoma with MYC and BCL2 rearrangements (HGBL-MYC/BCL2),
previously known as DHL.

 In
preclinical studies, LP-284 has shown nanomolar potency in several hematological cell lines. Of the hematological cell lines tested,
LP-284 had the highest potency against all 6 of the mantle cell lymphoma cell lines tested and 4 DHL cell lines tested. LP-284 is also
being explored for use as a combination therapy with spironolactone or rituximab. In the multiple myeloma cell line RPMI8226, combination
of 10 M spironolactone with LP-284 significantly reduced LP-284's IC50 by 2.4 fold. In the DHL cell line OCI-LY1 derived
xenograft model, LP-284 in combination with rituximab inhibited tumor growth by 93%, comparing to 57% tumor growth inhibition by rituximab
alone. In addition, the absence of ataxia telangiectasia mutated (ATM) function in these lymphomas and the need for new agents in the
setting of relapsed refractory mantle cell lymphomas support the development of LP-284 in this indication.

data from in vitro and in vivo studies supports LP-284's development for MCL, an aggressive
form of B-cell non-Hodgkin's lymphoma (NHL) with immediate patient needs. LP-284 treatment was demonstrated to have significantly
greater tumor growth inhibition (TGI) in mice implanted with MCL cell derived xenograft (CDX) tumors, when compared to treatment with
the standard-of-care (SOC) agents Ibrutinib or Bortezomib. The figure below describes results from LP-284 in-vitro and in-vivo
 preclinical studies for MCL and other B-cell Non-Hodgkin's lymphomas.

 Phase
1 Clinical Trial for LP-284

 We
are advancing LP-284 in a Phase 1 clinical trial open to enrollment of patients with relapsed refractory lymphomas and solid tumors.
In addition to determination of the recommended dose(s) for future Phase 1B and Phase 2 studies, we will also evaluate clinical activity
correlations with genomic alterations in DNA damage repair pathway genes. We expect to enroll up to 30 patients in the dose escalation
portion of the LP-284 Phase I trial, with the involvement of multiple clinical trial sites. As of the date of this report, we have four
clinical trial sites in the U.S. for the LP-284 Phase 1A study.

 Upon
completion of enrollment in the Phase 1A and analysis of safety, PK, and clinical activity data, we, together with the clinical investigators
participating in the study, will review the totality of the study data to determine the recommended dose(s) to be used in further clinical
testing of LP-284, including in Phase 1b.

 The
following is a summary of potential future clinical testing of LP-284 in Phase 1b. The conduct of these studies will be subject to the
evaluation of data from the LP-284 Phase 1a study and obtaining additional funding.

 For
Phase 1b, we currently plan to enroll up to 40 additional patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
and Mantle Cell Lymphoma (MCL) at the recommended dose(s) determined in Phase 1a, for further clinical evaluation, to characterize the
preliminary clinical activity, and tolerability of the treatment regimen before confirming the RP2D.

 Alteration
in DDR represents a vulnerability in lymphoma. Molecular profiling of lymphoma samples has shown that DDR is dysregulated in approximately
18% of the samples, with mantle cell lymphoma (MCL, 47%), and diffuse large cell lymphoma (DLBCL, 21%). Lymphoma cells are also characterized
by genomic instability in the form of chromosome translocation and fusion genes, leading to deregulated gene expression and uncontrolled
cell growth. Genetic aberrations in MCL include disrupted DDR response through Ataxia-Telangiectasia Mutated (ATM) gene mutation (which
occurs in approximately 43.5% of the MCL patients at baseline and 57.6% at disease progression) and TP53 gene mutation/deletion (occurring
in approximately 26.8% of MCL patients), deregulated B cell receptor (BCR) signaling pathway, and MYC rearrangement. DLBCL is genetically
heterogeneous. Some common dysregulated oncogenic pathways include PI3K, BCR, NF kappa B, and the apoptotic BCL2 family.

exerts antitumor activity by acting as an alkylating agent, covalently binding to DNA, RNA, and proteins, which leads to DNA damage,
impaired DNA/RNA synthesis, cell cycle arrests, and apoptosis. LP-284's antitumor activities were evaluated in 15 lymphoma
cell lines across various subtypes including MCL, DLBCL, and Burkitt's lymphoma. TP53 mutation, which is typically associated
with worse lymphoma prognosis, did not affect lymphoma cells' sensitivity to LP-284 in these studies. LP-284 appears to be
particularly lethal in cells with deficient DDR, a targetable vulnerability in lymphoma. LP-284 displays a unique profile of
preclinical antitumor activities compared to the FDA-approved alkylating agents for hematologic malignancy treatment. When
LP-284's in vivo anti-tumor activity in JeKo-1 derived MCL xenograft models were benchmarked with bortezomib and ibrutinib,
the percentage of tumor growth inhibition (TGI) in the LP-284 arms of the study outperformed the TGI observed with bortezomib and
ibrutinib and significantly prolonged MCL xenograft mouse survival by at least two-fold compared to control vehicles. JeKo-1 MCL
xenograft tumors refractory to bortezomib and ibrutinib, showed near complete tumor regression after one cycle of LP-284 treatment
in preclinical xenograft studies. In addition, LP-284 resulted in approximately two times longer survival than vehicle treatment in
the bortezomib or ibrutinib pre-treated and refractory xenograft mice. LP-284 treatment may be a viable salvage treatment plan for
patients who are refractory to current approved therapies.

 Disease
Background for Mantle Cell Lymphoma and DHL

 Mantle
Cell Lymphoma (MCL) is a rare, heterogenous and aggressive subtype of B-cell Non-Hodgkin's Lymphoma (NHL). MCL is a blood cancer
of the lymph nodes and tumor cells originating from the "mantle zone" of the lymph node and is characterized by constitutively
dysregulated cyclin D1 ( CCND1) expression. MCL is usually diagnosed at an advanced stage when it is largely considered
incurable.

 Nearly
all MCL patients relapse from the current MCL standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic
options for these patients. According to Leukemia and Lymphoma society about 4,200 new cases of
MCL are diagnosed in the United States annually, representing approximately 6% of all NHL patients.

 In
the most recent WHO classification of hematolymphoid malignancies, the entity diffuse large B-cell
lymphoma/high-grade B-cell lymphoma with MYC and BCL2 rearrangements (DLBCL/HGBL-MYC/BCL2) was named due to its distinct pathogenetic
and genomic features. DLBCL/HGBL-MYC/BCL2 is characterized by rearrangements in MYC and
BCL2 genes, previously known as double-hit or triple-hit lymphoma. This disease entity carries features intermediate between the DLBCL
and Burkitt lymphoma.

 The
prognosis of DLBCL/HGBL-MYC/BCL2 is poor with no standard treatment approach. Combination chemo-immunotherapies such as R-CHOP consisting
of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone is the most commonly used therapy, followed by the more intensive
regimen DA-R-EPOCH (dose-adjusted, rituximab, etoposide, prednisone, vincristine, cyclophosphamide,
and doxorubicin). About 20%-30% of patients are refractory to these frontline chemo-immunotherapies and the 2-year survival is
about 66%. The survival patients with relapsed/refractory (R/R) disease have even poorer prognoses with a reported median survival of
8.6 to 16 months. According to the Leukemia Foundation, HGBL-MYB/BCL2 represents approximately 5% of all DLBCL.

Opportunity for LP-284

presents a potential future market opportunity for relapsed or refractory non-Hodgkin's lymphoma (NHL). Approximately 40,000 to
80,000 patients annually have relapsed or refractory NHL, and many of these patients have limited therapeutic options. Potential LP-284
development opportunities include aggressive NHL subtypes, like mantle cell lymphoma (MCL) and high-grade B-cell lymphomas (HGBL), where
relapse rates are high and current treatments often fail. LP-284's potential is further underscored by the FDA's Orphan Drug
Designations for HGBL and MCL, plus granted patents in the U.S. and Japan.

 ADC
Program

 We
initiated an antibody-drug conjugate (ADC) program in 2021, based on the recognition of antibody drug conjugates as a promising therapeutic
approach for cancer treatment, and one that has growing interest due to the potential to increase targeted cancer cell death. ADCs can
provide the ability to take advantage of the high potency of cytotoxic payloads and the superior specificity of antibodies. The drug
antibody conjugate thus provides the potential to maximize efficacy and minimize systemic toxicity. Since the initiation of our ADC program,
we have evaluated various cytotoxic agents and classes of agents to be used as potential ADC payloads. We have also selected and ranked
multiple targeting antibodies of interest with potential to be linked to selected cytotoxic payloads.

 During 2024, we continued to progress the application of our RADR
A.I. platform to advance and refine an A.I. powered module focused on improving the precision, cost and timelines of ADC development for
cancer. In
2023, we entered into a research collaboration with Bielefeld University in Germany focused on development of ADCs utilizing cryptophycin
as the ADC drug-payload. Cryptophycins are promising antitumor molecules that have demonstrated potency at ultra-low, picomolar, concentrations.
Professor Norbert Sewald, Ph. D., a leading expert in the synthesis of cryptophycins and development of ADCs, led the collaborative
work conducted by Bielefeld University. The collaboration also leveraged insights from Lantern's RADR AI ADC
module.

 The
collaboration terms provided for Dr. Sewald and his group to synthesize, optimize, and provide initial preclinical testing of cryptophycin-ADCs.
Lantern also received an exclusive and worldwide option to license intellectual property (IP)
from Bielefeld University related to the collaboration and IP generated from the collaboration.

 In
a broad range of preclinical studies, the cryptophycin-ADC synthesized as part of the Bielefeld collaboration demonstrated promising
picomolar level potency and anti-tumor activity in multiple solid tumor cell lines, including breast, bladder, colorectal, gastric, pancreatic
and ovarian. We are evaluating these indications for potential further ADC development.

 We
believe the drug-payload, cryptophycin, has the potential to improve upon existing ADCs used in the clinical setting by: 1) improving
the anti-tumor potency of the ADC molecule, and 2) overcoming drug resistance that tumors can frequently develop to existing ADC drug-payloads.
We also believe our strategic, data-driven approach of utilizing cryptophycin as a highly potent and novel payload alongside the prioritization
of biologically novel and relevant targets with scalable and efficient drug conjugate formats will help expand the repertoire and diversity
of ADC opportunities. Lantern is also utilizing our AI platform, RADR to further refine and understand other potential
ADC oncology targets, with a focus on prioritizing targets that are expressed across multiple tumor types or subtypes and have few or
no therapeutic ADC options.

or 6-Hydroxymethylacylfulvene (or irofulven) exploits cancer cells' deficiency in DNA repair mechanisms. We believe LP-100 has
the potential to be an important compound — either as monotherapy or in combination — for several challenging cancers that
are impacting patients globally.

 In
2023, we announced data for LP-100 supporting the development of LP-100 in combination with the class of anticancer agents known as PARP
inhibitors (PARPi). In prostate cancer mouse xenograft studies, LP-100 demonstrated synergistic potency when used in combination with
the FDA-approved PARP inhibitor Olaparib. LP-100 also demonstrated synergy with the FDA-approved PARP inhibitors Olaparib, Rucaparib,
and Niraparib in ovarian cancer cell line studies. The observations from these studies are further supported by in-silico evaluation
of LP-100 in combination with PARP inhibitors using Lantern's RADR platform. We believe this development focus
will enhance the potential to position LP-100 in earlier lines of therapy, while also opening the door to pursue treatment indications
with larger market sizes.

has previously been in a genomic signature guided phase 2 clinical trial in Denmark for patients with metastatic castration resistant
prostate cancer (mCRPC). 9 patients (out of a targeted enrollment of 27) were treated in the trial. The median overall survival (OS)
for the initial group of 9 patients was approximately 12.5 months, which is an improvement over other similar fourth-line treatment regimens
for mCRPC. Based on our evaluation of the synergies of LP-100 with PARP inhibitors, the decision was made to close the phase 2 clinical
trial in Denmark, to allow the focus of LP-100-directed resources on positioning the molecule for development in earlier lines of therapy
with potentially larger market opportunities. Earlier line treatment indications where we believe LP-100 in combination with PARPi could
have potential future treatment benefits include prostate cancer indications such as HRR gene-mutated metastatic castration-resistant
prostate cancer, ovarian cancer indications such as first line platinum-responsive advanced ovarian cancer, and breast cancer indications
such as germline BRCA -mutated metastatic breast cancer.

and PARP inhibitors act by complementary mechanisms. LP-100 acts by a synthetically lethal mechanism of action that preferentially damages
DNA in cancer cells lacking nucleotide excision repair (NER) capabilities. PARP inhibitors have been shown to be effective in the treatment
of tumors with deficiencies in homologous recombination repair (HR). We believe the simultaneous exploitation of both these mechanisms
will enhance the development opportunities for LP-100, while also expanding potential market opportunities for existing PARP inhibitors.

 In
July 2021, we entered into an Asset Purchase Agreement to reacquire global development and commercialization rights for LP-100 from Allarity
Therapeutics A/S, which previously managed the current Phase 2 trial for LP-100. As a result of the Asset Purchase Agreement, we obtained
full authority to manage and guide future clinical development and commercialization of LP-100.

 In
conjunction with our evaluation work on LP-100 with PARP inhibitors, we have been collaborating with the Danish Cancer Society Research
Center (DCSRC) to explore the future clinical potential of LP-100 across 9 different solid tumor types that have known deficiencies
in DNA repair pathway mechanisms. This work has included examination of the role of NER deficiency in breast, ovarian, prostate, lung,
kidney, bladder, stomach, pancreatic, and esophageal cancers, with the aim of identifying the most promising patient populations for
future LP-100 therapy.

 History
of LP-100

shows multiple cytotoxic effects on tumor cell biology such as DNA adduct formation, RNA polymerase stalling and redox protein modification.
It demonstrates enhanced sensitivity in DNA repair deficient (e.g. ERCC3 mutant or knockout) in vitro and in vivo models.
In historical testing, clinical antitumor activity for LP-100 was observed in approximately 10-12% of patients with multidrug resistant
advanced prostate cancer with notable resolution of bone metastases.

belongs to the family of compounds and small molecular entities (molecular weight <330) that represent a class of anticancer agents
derived from fungal toxins called Illudins. Acylfulvenes were originally synthesized and developed by Drs. Michael J. Kelner and Trevor
C. McMorris at University of California at San Diego ("UCSD"). In 1987, Professor McMorris published the first preclinical
evaluation of the Illudins as anticancer agents and a library of hundreds of acylfulvene derivatives was created, many with significant
 in vitro and in vivo antitumor activity and potentially improved selectivity for tumor cells versus normal cells. The compound
Illudin S was found to be highly cytotoxic against cancer cells, but demonstrated a poor therapeutic index. Better understanding of the
mechanism of action led to the development of a novel family of semisynthetic antitumor agents, or next-generation acylfulvenes such
as 6-hydroxymethylacylfulvene, now designated as LP-100. LP-100 is a semisynthetic derivative of Illudin S, one of a series of sesquiterpene
natural products (Illudins) isolated from the Lantern mushroom Omphalotus illudens. LP-100 was selected for further study based
on its potential to demonstrate promising antitumor activity while maintaining a more favorable therapeutic index, compared to previously
studied Illudins. The chemical structure of LP-100 is depicted below.

Chemical Structure

 Mechanism
of Action

leads to rapid inhibition of DNA synthesis and induction of DNA damage. LP-100 is a monofunctional covalent DNA binder that inhibits
DNA synthesis and replication, affects cell cycle and induces apoptosis. DNA repair of LP-100-induced lesions is mediated by components
of the transcription-coupled nucleotide excision repair (TC-NER) pathway. LP-100 produces damage to DNA that can only be repaired by
the TC-NER pathway. The DNA damage is unique, as two enzymes, RNA Polymerase III and Topoisomerase I (Topo 1), associated with the TC-NER
are displaced leading to irreversible inactivation of the repair pathway. Other conventional DNA damaging chemotherapeutic agents, such
as cisplatin, etoposide, doxorubicin and others, produce general damage that can be repaired by the Global Genome Nucleotide Excision
Repair (GG-NER) pathway. Tumor cells often develop multidrug resistance (MDR) making them impossible to kill using conventional drugs.
LP-100 appears to retain activity against MDR tumor cells regardless of the mechanism of resistance and tumor cells appear less likely
to become resistant to LP-100. Killing of MDR tumor cells by LP-100 reflects its unique mechanism of disrupting the TC-NER pathway. Cell-based
studies have demonstrated selective cytotoxicity of LP-100 towards a variety of solid tumor cell lines. The tumor cells cannot recover
from this damage, undergo S-phase arrest, and then irreversibly initiate both caspase-dependent and –independent apoptosis pathways.
LP-100 produces DNA damage and induces apoptotic DNA fragmentation in several tumor cell lines. Normal diploid cells, in contrast, do
not normally need repair by the TC-NER pathway unless exposed to UV light. Treatment of mouse xenografts of human tumors with LP-100
results in tumor shrinkage. Synergistic or additive activity is observed when LP-100 is combined with various traditional anticancer
agents.

Clinical Profile

 Clinical
studies of LP-100 have been conducted in multiple solid tumor indications including prostate, ovarian, colorectal, pancreatic, thyroid,
lung, breast and gastric cancers. More than 38 Phase 1 or Phase 2 trials involving > 1,300 patients have been conducted with LP-100.
In prior clinical trials, LP-100 showed activity and produced regression in a variety of cancers, but failed to meet required endpoints
for clinical trial success. Objective responses were reported for LP-100 single agent therapy in drug-resistant prostate (hormone and
taxotere refractory), ovarian (platinum resistant), pancreatic, sarcoma, kidney, endometrial, and lung cancers. LP-100 also showed cancer
treating potential when administered in combination with a variety of conventional chemotherapeutics including Camptosar, GemZar, Taxotere,
Xeloda, Cisplatin, and Oxaliplatin. In a study of patients who failed prior conventional therapies, two rounds of LP-100 therapy led
to rapid resolution of ovarian cancer metastasis. In a randomized Phase 2b study of patients with metastatic hormone refractory taxotere-resistant
prostate cancer, LP-100 was compared to mitoxantrone. A total of 138 patients were enrolled and specified endpoints included overall
survival, response rate, and safety assessment. The median one-year survival increased from 22% in the mitoxantrone-treated control group
to 41% in the LP-100-treated group. Median overall survival was 10.1 months for treatment arm (LP-100 + Prednisone) and 7.4 months for
control arm (Mitoxantrone + Prednisone), i.e. a 37% increase over standard of care. Treatment was well-tolerated in all arms. The most
frequent Grade 3–4 toxicities (as % of patients in treatment/control arms) were asthenia (8%/0%), and vomiting (4%/0%). Grade 3–4
hematological events included neutropenia (22%/61%) and thrombocytopenia (23%/4%).In 2001, LP-100 received FDA's fast track status
and a Phase 3 international clinical trial for LP-100 in refractory pancreatic patients was started. Clinical trials looked promising
in shrinking tumors of drug-resistant pancreatic cancer. However, MGI Pharma stopped the Phase 3 clinical trial because it was unlikely
for the trial to reach its objective due to a greater than expected survival benefit associated with the comparator agent (5-FU). In
2005, Phase 2 clinical trial results of LP-100 in women with recurrent and heavily pre-treated ovarian cancer revealed retinal toxicity.
This retinal damage was associated with dose and administration of drug.

 AF
Chemicals

 In
January 2015, the Company entered into a Technology License Agreement to exclusively license domestic and international patent rights
from AF Chemicals, LLC ("AF Chemicals") for the treatment of cancer in humans for the compounds LP-100 (Irofulven) and LP-184.
In February 2016, the Company and AF Chemicals entered into an Addendum (the "Addendum") providing for additions and amendments
to the Technology License Agreement. In December 2020, the Company and AF Chemicals entered into a Second Addendum (the "Second
Addendum") providing for further additions and amendments to the Technology License Agreement. The Technology License Agreement,
Addendum and Second Addendum are collectively referred to as the "AFC License Agreement".

to the Second Addendum, the Company made specified payments to AF Chemicals during the 12 months ended December 31, 2024. The Second
Addendum also provides that, from December 30, 2020 until January 15, 2025, the Company will have no obligation to pay annual licensing
fees, development diligence extension payments, or patent maintenance fee payments to AFC under the AFC License Agreement.

 As
part of the Second Addendum, the Company has agreed to apply for specified orphan drug designations for LP-184 in the US and EU. The
Second Addendum also amends and clarifies other provisions of the Technology License Agreement, and provides the Company with the ability
to recover a portion of initial payments made under the Second Addendum from sublicense fees or royalty payments that may be made to
AFC by the Company or third parties prior to January 15, 2025.

to the AFC License Agreement, the Company made annual licensing fee payments to AF Chemicals relating to LP-184 for periods prior to signing
the Second Addendum. In addition, the Company is obligated to make milestone payments to AF Chemicals at the time of an Investigational
New Drug Application ("IND") filing relating to LP-184 and other analogs, such as LP-284, and also upon reaching additional
specified milestones in connection with the development and potential marketing approval of LP-184 and LP-284 in the United States, specified
countries in Europe, and other countries.

 The
AFC License Agreement also provides that the Company will pay AF Chemicals a royalty of at least a very small single digit percentage
of specified net sales of LP-184 and other analogs, such as LP-284. In addition, the AFC License Agreement contains specified time requirements
for the Company to file an IND, enroll patients in clinical trials, and file a potential NDA with respect to LP-184 or other analogs,
with the ability for the Company to pay AF Chemicals additional amounts ranging up to an amount in the low hundreds of thousands of dollars
for each one, two, three and four year extension to such development time requirements, with additional extensions beyond four years
to be negotiated by the Company and AF Chemicals.

to the Second Addendum, no additional payments of annual licensing fees or development diligence extension payments are required to be
made by the Company until January 15, 2025, at which time these obligations have resumed. The Company is also obligated to make annual
licensing fee payments to AF Chemicals relating to LP-100 beginning January 15, 2025, as described below under Allarity Therapeutics.

 In
the event of a sublicense of the rights to LP-184, LP-284 or other analogs to a non-affiliated party, the Company is obligated to pay AF Chemicals (a) a low
double digit percentage of the gross income and fees received by the Company with respect to the United States in connection with
such sublicense, and (b) a lower double digit percentage of the gross income and fees received by the Company with respect to Europe
and Japan in connection with such sublicense.

 The
amounts to be paid to AF Chemicals with respect to LP-100 under the AFC License Agreement are in many ways similar to the amounts to
be paid with respect to LP-184 as described above. In addition, the AFC License Agreement contains specified time requirements for the
Company to enroll patients in clinical trials, and file a potential NDA with respect to LP-100. Extension fees may be paid by the Company
to AF Chemicals from time to time related to these requirements. Pursuant to the Second Addendum with AF Chemicals, no additional payments
of annual licensing fees or development diligence extension payments were required to be made by the Company with respect to LP-100 until
January 15, 2025, at which time these obligations have resumed.

 Allarity
Therapeutics

 In
May 2015, the Company licensed various rights to LP-100 to Oncology Venture (now known as Allarity Therapeutics) pursuant to a Drug License
and Development Agreement. In February 2016, the Company and Allarity Therapeutics entered into an addendum and an amendment providing
for additions and amendments to the Drug License and Development Agreement. In connection with the Drug License and Development Agreement,
as amended (collectively, the "Allarity License and Development Agreement"), Allarity Therapeutics agreed to directly pay
to AF Chemicals on behalf of the Company certain amounts to satisfy the Company's milestone obligations to AF Chemicals with respect
to LP-100 under the AFC License Agreement. Amounts paid by Allarity Therapeutics to AF Chemicals on behalf of the Company would then
be deducted from amounts owed by Allarity Therapeutics to the Company.

 On
July 23, 2021, the Company entered into an Asset Purchase Agreement to reacquire global development and commercialization rights for
Irofulven (LP-100) from Allarity. The transaction included global rights to LP-100, as well as the developed clinical protocol for an
intended study in bladder and prostate cancer patients who have a mutation in the ERCC2/3 genes. As a result of this transaction, the
Company obtained full authority to manage and guide future clinical development and commercialization of LP-100. Under the terms of the
Asset Purchase Agreement, the Company paid an initial upfront payment of $1,000,000 to Allarity, with an additional $1,000,000 held in
escrow. The Company determined there was no planned alternative future use for these assets outside of the clinical development of LP-100
and therefore the full amount of the upfront payment was included in research and development expense during the year ended December
31, 2021. The Company released approximately $459,000 from escrow to Allarity related to recertification of LP-100 drug stock during
the year ended December 31, 2022. The escrow period under the Asset Purchase Agreement ended in July 2023, and the remaining escrow funds
of approximately $541,000 were distributed from escrow to the Company in August 2023. Allarity is also eligible to receive additional
milestone payments over the life of the program based on IP license milestones and regulatory filings and approvals in the US and EU,
and low- to mid-single-digit royalties on future commercial net sales. As part of the Asset Purchase Agreement, the Allarity License
and Development Agreement was terminated.

Research and Development Collaborations for Our Drug Candidates

 Virtually
all of our product candidate developmental work is expected to be performed in contract labs, academic institutions and other external
research centers in the near future, and most of it requires close collaboration with these groups. Our strategic collaborations have
specialized focus areas tailored to advancing our pipeline drug candidates and provide expertise benefits. We are or have been involved
in the following collaborations relating to development of our product candidates.

 Collaborator

 Focus Area

 Drug Candidate

 National Cancer Institute (NCI)

 Gene signature development and drug sensitivity prediction

 LP-184, LP-284

 Georgetown University

 Evaluation of drug activity and sensitivity in prostate and pancreatic cancer organoid models and engineered pancreatic cancer cell lines

 Fox Chase Cancer Center (FCCC)

 Determination of drug activity in PDX tumor models

 Kennedy Krieger Institute and the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

 Evaluation of activity of LP-184 in glioblastoma (GBM).

 Danish Cancer Society Research Center

 Examine and develop genomic signatures of TCNER deficiency that have potential to correlate with sensitivity to LP-100 and LP-184 in solid tumors

 LP-100, LP-184

 Greehey Children's Cancer Research Institute-UT Health San Antonio

 Evaluation of drug activity in pediatric tumor models

 LP-184, LP-284

 Manufacturing

 We
do not currently own or operate any manufacturing facilities or have any manufacturing employees. We currently rely, and expect to continue
to rely, on third party contract manufacturing organizations ("CMOs") for the manufacturing of our drug candidates for preclinical
uses, clinical trials as well as for commercial manufacturing if our drug candidates receive marketing approval. We require that our
CMOs produce bulk drug substances and finished drug products in accordance with current Good Manufacturing Practices ("cGMPs")
and all other applicable laws and regulations. We maintain agreements with our manufacturers that include confidentiality and intellectual
property provisions to protect our proprietary rights related to our drug candidates. We obtain our supplies from these CMOs on a project
by project basis and do not have long-term supply arrangements in place. We do not currently have arrangements in place for redundant
supply. For all of our drug candidates, we intend to identify and qualify additional manufacturers to provide the active pharmaceutical
ingredient and fill-and-finish services prior to seeking regulatory approval.

and LP-284 Manufacturing

 We
have contracted with Shilpa Medicare Limited and affiliates ("Shilpa") for the cGMP synthesis of LP-184 API material as well
as for drug product development and cGMP drug product manufacturing of LP-184. In addition, we have contracted with Shilpa for the cGMP
synthesis of LP-284 API material as well as for drug product development and cGMP drug product manufacturing of LP-284.

Manufacturing

 We
have contracted with Curia Global, Inc. ("Curia") for the manufacture and supply of LP-300 cGMP API material. We have contracted
with Berkshire Sterile Manufacturing ("Berkshire") and Piramal Pharma Solutions ("Piramal") for the provision
of services relating to cGMP drug product manufacturing of LP-300.

 Commercialization

 We
retain worldwide commercialization rights for our product candidates LP-300, LP-184, LP-284, and LP-100. We plan to continue considering
out-license and collaboration opportunities in order to maximize returns and pursue successful development of our key candidates. We
currently have no sales, marketing or product distribution capabilities. However, once we have key candidates closer to FDA approval,
we may build our own specialty sales force, partner with a larger pharmaceutical organization, or out-license our drug candidates.

 We
are continually evaluating out-license opportunities for our candidates at later stages of development in order to focus on identifying
and licensing additional drug candidates for novel indications and/or patient subpopulations with an oncology focus for expansion of
our pipeline.

 Our
commercial plans and strategy for each particular program may change as our programs advance, the markets change, we receive more clinical
data, and depending on availability of capital.

 Intellectual
Property

 We
have an extensive multi-national portfolio of intellectual property rights directed to our drug candidates, and their targeted use and
development in specific patient populations and in specific therapeutic indications.

 As
of March 1, 2025, we own or control rights in over 195 active patents and patent applications across 15 patent families whose claims
are directed to our drug candidates and what we plan to do with our drug candidates. We have in-licensed or acquired patents and patent
applications from AF Chemicals, and BioNumerik directed to the compounds, LP-100, LP-184, LP-284 and LP-300, our RADR platform,
and methods of using the compounds. Additionally, we have also filed patent applications to further enhance and extend the use of these compounds. Our patents are directed to our drug candidates, their usage, manufacturing, and other matters. These matters
are essential to precision oncology and relate to: (a) data-driven, biologically relevant biomarker signatures, (b) patient selection
and stratification approaches that rely on prediction of response deriving from these signatures and, (c) the ability to develop novel,
combination therapy approaches with existing approved therapeutics.

 We
rely on a combination of patents, trade secrets, copyrights, trademarks, license agreements, nondisclosure and other contractual provisions
and technical measures to protect our intellectual property rights. Additionally, we also rely on the patent applications, trade secrets,
and other contractual provisions and technical measures to protect the development of our genomic and biomarker signatures that help
us in making predictions about the sensitivity to our drug candidates, our patient stratification approaches, and the development of
potential combination therapies with our drug candidates.

 Intellectual
Property Portfolio by the Numbers

 As
of March 1, 2025, our intellectual property portfolio consisted of 15 patent families covered by:

 Over
 45 issued patents across our portfolio of compounds in key, commercially important geographies;

 Over
 150 pending patent applications, including eight Patent Cooperation Treaty (PCT) applications;

 as
 well as pending trademark registrations, and trademark applications in Japan, Europe, Canada and Australia.

 Our
policy is to protect the proprietary technologies, inventions, and improvements that are commercially important to our business in the
United States, Europe, Japan, Australia and other key jurisdictions important to our business. We fully expect that additional advances
will come out of our ongoing work in developing biomarker signatures and patient stratification approaches and that these advances will
form the basis of additional intellectual property protection through new patent filings, trademarks, trade secrets, and copyrights.
We will continue to file patent applications and use trade secret laws to protect the uses of our genomic and biomarker signatures, response
prediction and patient stratification discoveries. We plan to rely on these intellectual property advances to develop, strengthen, and
maintain our proprietary position for novel therapeutics and novel formulations and uses of existing and new compounds across multiple
therapeutic areas. We also plan to rely on data exclusivity, market exclusivity and patent term extensions when available.

 Patent
Portfolio

 We
have an extensive multi-national portfolio of intellectual property rights directed to our drug candidates, and their targeted use and
development in specific patient populations and in specific therapeutic indications. Our portfolio consists of over 15 patent families
across issued patents and pending patent applications. We have also filed over 15 patent applications directed to our proprietary drug
programs together with biomarkers and sensitivity parameters, and four additional patent applications directed to our RADR
 platform. These filings include patent applications directed to LP-300 and additional patent applications directed to new manufacturing
methods for novel, synthetic illudins, and gene signatures and biomarker profiles indicating sensitivity to LP-100, LP-184, LP-284 and
synthetic illudins.

 Our
 patent family directed to LP-100 has patents that expire as early as August 2026, and patent applications, if granted, that would
 expire as late as May 2040.

 Our
 patent family directed to LP-184 has patents that expire as early as August 2026, and patent applications, if granted, that would
 expire as late as May 2040.

 Our
 patent family directed to LP-300 has patents that expire as early as March 2028, and patent applications, if granted, that would
 expire as late as March 2044.

 Our
 patent family directed to LP-284 has patents that expire as early as August 2038, and patent applications, if granted, that would
 expire as late as May 2042.

 We
typically file a non-provisional patent application or a PCT within 12 months of filing the corresponding provisional patent application.
While we intend to timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict
whether any of our existing or future patent applications for our existing or future drug candidates will result in the issuance of patents
that effectively protect these candidates, or if any of our issued patents or if any of our licensor's issued patents will effectively
prevent others from commercializing competitive products. Patent protection for the composition of matter of the LP-300 compound itself
is unavailable because the compound was first identified many years ago. For more information regarding the risks related to our intellectual
property, see "Risk Factors – Risks Related to Our Intellectual Property."

 RADR
 Platform

 We
do not own or in-license any patents on our RADR platform, but we have filed at least four patent applications directed
to our RADR platform and rely on trade secrets and confidential procedures directed to protecting:

 our
 A.I. and machine learning and training methodologies for our specific purposes in oncology drug development and drug rescue,

 our
 curation and normalization of select data from both public and proprietary data sources, and

 our
 developing insights that can be modeled to cover biological processes as algorithms inside our RADR platform.

 Our
portfolio directed to LP-100 consists of at least two families of in-licensed patents that were filed in 2006. The patents include European,
Japanese and US patents. US Patent No. 7655695 relates to acylfulvene analogs that are directed to tumor solid tumor growth inhibition.
The nominal expiration for our patents directed to LP-100 is August 2026 and does not account for any applicable patent term adjustments
or extensions. We have also filed multiple patent applications directed to LP-100 that, if granted, would expire as late as May 2040.

& other Novel, Synthetic Illudin Derivatives

 Our
portfolio directed to LP-184 consists of over ten families of patents and patent applications and includes six PCT applications. US Patent
No. 7655695 relates to acylfulvene analogs that are directed to solid tumor growth inhibition. The patent applications include claims
directed to use of LP-184, synthetic illudin analogs or derivatives to treat glioblastoma or other CNS cancers as either a mono or combination
therapy, to treat rhabdoid tumors, brain cancer, brain metastases, and pancreatic cancer also as either a mono or combination therapy.
The nominal expiration for patents and patent applications directed to LP-184 ranges from 2026 to as late as 2042 and does not account
for any applicable patent term adjustments or extensions. We intend to nationalize our patent applications in the US, Australia, Canada,
EU, China, and Japan.

 We
have in-licensed patents from AF Chemicals related to the composition of matter of LP-184. We have also developed additional intellectual
property for this class of compounds related to the development of novel synthetic routes and the preparation of certain illudin derivatives
having therapeutic value. Additionally, we have filed patent applications on the use of LP-184 and these novel synthetic illudin derivatives
in the treatment of glioblastoma and other CNS cancers.

& other Novel, Synthetic Illudin Derivatives

 Our
portfolio directed to LP-284 consists of at least four patent and patent application families. US Patent No. 7655695 relates to acylfulvene
analogs that are directed to solid tumor growth inhibition and US Patent No. 11739043 covers the compound itself. Other patent applications
are directed to using LP-284 to treat leukemia and blood cancers and other cancers (as either a mono or combination therapy). The nominal
expiration for patents and patent applications directed to LP-284 ranges from 2026 to as late as 2042 and does not account for any applicable
patent term adjustments or extensions. We intend file or nationalize our patent applications in the US, Australia, Canada, EU, China,
and Japan.

 Our
portfolio directed to LP-300 consists of at least four families of owned patents. A more recent PCT patent application filed in 2020
is directed to treatment of non-small cell lung cancer (NSCLC) in nonsmokers and never smoking patients using disodium 2,2'-dithio-bis-ethane
sulfonate (dimensa) and has been nationalized in the US, Canada, Brazil, Mexico, EU, China, Japan and Australia. The nominal expiration
for NSCLC related patents and patent applications directed to LP-300 ranges from 2028 to as late as 2040 and does not account for any
applicable patent term adjustments or extensions.

 We
filed an additional PCT application directed to LP-300 and its application to NSCLC, as well as biomarkers that correlate to heightened
response or sensitivity to LP-300.

 Confidentiality
& Trade Secrecy

 We
enter into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research
and development output, such as our employees, collaborators, contract research organizations, contract manufacturers, consultants, advisors
and other third parties. It is possible, however, that any of these parties may breach the agreements and disclose such output before
a patent application is filed, thereby jeopardizing our ability to seek patent protection. These agreements in general provide that all
confidential information developed or made known during the course of an individual or entities' relationship with us must be kept
confidential during and after the relationship. These agreements also generally provide that all inventions resulting from work performed
for us or relating to our business and conceived or completed during the period of employment or assignment, as applicable, shall be
our exclusive property. It is also possible that third parties may develop substantially equivalent proprietary information, platforms
or compounds, or otherwise gain access to our trade secrets.

 Trademarks

 We
own various trademarks, applications and unregistered trademarks in the United States and other commercially important markets, including
our company name, our A.I. platform, and certain compounds in development. Our trademark portfolio is designed to protect the brands
for our Company, our A.I. platform and our portfolio of compounds.

 Other
Intellectual Property

 We
believe that our intellectual property rights on the RADR platform are valuable and important to our business. Our patent
position relating to the RADR platform is generally uncertain and involves complex legal and factual questions, which is consistent with
patent claims regarding intellectual property of this nature. We rely on a combination of trademarks, copyrights, trade secrets, license
agreements, confidentiality procedures, non-disclosure agreements, employee disclosure, and invention assignment agreements, and other
legal and contractual rights to establish and protect our proprietary rights.

 Competition

 We
exist at the intersection of rapidly moving, global industries, namely, the biotechnology industry and the A.I. drug development industry.
This is a unique and rapidly moving category with a variety of business models being developed globally. The pharmaceutical and biotechnology
industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on intellectual property. A.I.
is disrupting and changing all industries, including the biotechnology industry. Although these are competitive industries, we believe
we are uniquely positioned due to our focus on oncology drug development, prediction of patient response, use of computational biology,
and the ability to both rescue and develop compounds.

 We
face potential competition from many different sources, including major pharmaceutical and biotechnology companies, academic institutions
and governmental agencies, and public and private research institutions.

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

 Our
commercial opportunity could be reduced or eliminated if our competitors develop and commercialize medicines that are safer, more effective,
have fewer or less severe side effects, and are more convenient or less expensive than any medicines we may develop. Our competitors
also may obtain FDA or other regulatory approval for their medicines 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. In addition, our ability to compete
may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic medicines.

 Any
drug candidates we successfully develop will compete with current and new therapies that may become available in the future. The key
competitive factors affecting the success of all of our drug candidates, if approved, are likely to be their efficacy, combinability,
safety profile, convenience, cost, the effectiveness of companion diagnostics in guiding the use of related therapeutics, if any, the
level of generic competition, level of promotional activity, intellectual property protection, and the availability of reimbursement
from government and other third-party payors. If any drug candidates under development are approved for the indications in which we are
currently planning clinical trials, they will compete with the drugs discussed below and will likely compete with other drugs in development.

 Artificial
Intelligence and Drug Development

 We
believe our proprietary RADR platform gives us a significant competitive advantage for using AI to both: 1) select, model
and license drugs with a well-tolerated safety profile, and 2) quickly and cost-effectively advance drugs towards market by selecting
biologically relevant mechanisms of action and their associated biomarkers of activity. Recently, there has been an increase in the use
of AI for drug development, and for improved biomarker signature creation correlated to drug response. Due to this recent increase, we
face increasing competition in both: 1) developing new drugs, and 2) biomarker signature development. This includes competition with
respect to the pool of already existing drug candidates that may be amenable for patient stratification. Our competition in AI-driven
drug development for oncology includes, but is not limited to, the following:

 - Oncology-focused
clinical stage companies: Candel Therapeutics, Pyxis Oncology, Foghorn Therapeutics, Prelude Therapeutics, Warewolf
Therapeutics, Xilio Therapeutics, Ikena Oncology, Atossa Therapeutics, Elevation Oncology, Bolt Biotherapeutics.

 -
 AI-focused drug developers with proprietary pipelines: AbCellera, Atomwise, InSilico Medicine, Iktos, Verge Genomics,
Recursion Pharmaceuticals, Schrodinger, and Roivant Sciences.

 There
are approved standards of care agents for treating pancreatic cancer that are dominated by FOLFIRINOX (consisting of leucovorin calcium
(folinic acid), fluorouracil, irinotecan, and oxaliplatin) and gemcitabine-based cytotoxic chemotherapeutic regimens. In February 2024
the FDA approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the
first-line treatment of metastatic pancreatic adenocarcinoma. However, these regimens cause dose limiting toxicities. Liposomal irinotecan
(Onivyde) in combination with 5-FU and LV is recommended in patients that progressed on gemcitabine therapy. In a small subset of
patients exhibiting genetic mutations such as those with neurotrophic receptor tyrosine kinase (NTRK) gene fusions, breast cancer gene
(BRCA) 1/2 mutations, or patients with elevated microsatellite instability (MSI)-DNA mismatch repair (MMR) status, recently approved
targeted therapies such as Vitrakvi and Rozlytrek (approximately 1% of pancreatic cancer patients), poly ADP-ribose polymerase (PARP)
inhibitor Lynparza (approximately 5-8% of pancreatic cancer patients) and Keytruda (approximately 1-2% of pancreatic cancer patients)
are currently included in treatment guidelines. On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri,
Merus N.V.) for adults with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma, both
harboring a neuregulin 1 (NRG1) gene fusion. For eligible patients, paclitaxel (Abraxane) or docetaxel has been used in the third-line
setting in combination with gemcitabine. We believe that currently, no adequate treatment options are available for as much as 80% of
advanced stage pancreatic cancer patients.

 New
agents are also being actively developed for the potential treatment of pancreatic cancer. The competition we may face regarding LP-184
for the potential treatment of pancreatic cancer includes without limitation the following agents that have not yet received marketing
approval for the treatment of pancreatic cancer: the chemotherapeutic agent-glufosfamide; the tyrosine kinase inhibitor-Masiviera (masitinib);
RAS inhibitors MRTX1133 and RMC-6236; the PARP inhibitor fluzoparib; Interleukin 1 receptor antibody nadunolimab; 5' Nucleotidase
Inhibitor quemliclustat; transforming growth factor beta-2 inhibitor trabedersen; and anti PDL-1 antibody spartalizumab.

 The
standard treatment for glioblastoma includes radiation and chemotherapy with temozolomide. Based on an article in the journal Genes and
Diseases ( Temozolomide resistance in glioblastoma multiforme, Genes Dis., 2016 May 11;3(3):198-210) and other publications, at
least fifty percent of temozolomide treated patients do not respond to this treatment, and others often form resistance to temozolomide
based regimens. Bevacizumab is frequently used for recurrent glioblastoma.

 New
agents are also being actively developed for the potential treatment of glioblastoma. The competition we may face regarding LP-184 for
the potential treatment of glioblastoma includes without limitation the following: the chemotherapeutic agents Berubicin, and the protein
kinase inhibitors Stivarga (Regorafenib), DB102 (Enzastaurin hydrochloride) and BDTX-1535 and DNA Damage Repair pathway inhibitors such
as PARP inhibitors. There are also several immunotherapies in late-stage development for glioblastoma, including oncolytic viruses and
tumor cell vaccines.

 Triple
Negative Breast Cancer

 The
absence of ER, PR, HER2 markers predisposes TNBC to rapid metastasis, treatment resistance, and a high recurrence rate. In addition,
the absence of these receptors limits treatment options for TNBC patients. While TNBC can resist hormone therapy, and immunotherapy in
many instances, TNBC is often sensitive to chemotherapeutic agents and radiotherapy.

 Standard
treatment options for TNBC include:

 Chemotherapy:
 Chemotherapy is often the primary systemic treatment for TNBC. Anthracycline-based regimens (such as doxorubicin and epirubicin)
 and taxane-based regimens (such as paclitaxel and docetaxel) are commonly used. Platinum-based drugs like cisplatin or carboplatin
 may also be included in the treatment regimen for some patients.

 Surgery:
 Surgery is usually recommended to remove the tumor, and may involve a lumpectomy or a mastectomy. In some cases, lymph node dissection
 may also be performed to check for the spread of cancer to nearby lymph nodes.

 Radiation
 Therapy: Radiation therapy is often given after surgery to reduce the risk of cancer recurrence. It may also be used as part of the
 primary treatment for patients who opt for breast-conserving surgery (lumpectomy) instead of mastectomy.

 Immunotherapy:
 In recent years, immunotherapy has shown promising results in the treatment of TNBC, particularly in patients whose tumors express
 programmed death-ligand 1 (PD-L1). Pembrolizumab, a PD-1 inhibitor, has been approved for use in combination with chemotherapy as
 first-line treatment for metastatic TNBC with PD-L1 expression.

 PARP
 Inhibitors: Poly (ADP-ribose) polymerase (PARP) inhibitors, such as olaparib and talazoparib, have been approved for the treatment
 of advanced TNBC with germline BRCA mutations.

 If
an early-stage TNBC is small enough to be removed by surgery, then breast-conserving surgery or a mastectomy with a check of the lymph
nodes may be done. In certain cases, such as with a large tumor or if the lymph nodes are found to have cancer, radiation may follow
surgery. Chemotherapy after surgery (adjuvant chemotherapy) can reduce the chances of the cancer coming back. For women who have a BRCA
mutation and at surgery are found to have a tumor larger than 2cm but no bigger than 5cm OR 1 to 3 axillary lymph nodes with cancer,
the targeted PARP inhibitor olaparib might be given for a year after adjuvant chemo. When given this way, it can help some women live
longer. Chemotherapy is often given before surgery (neoadjuvant chemotherapy) by itself or with pembrolizumab (Keytruda) to shrink a
large tumor and/or lymph nodes with cancer. If cancer is still found in the tissue removed by surgery after neoadjuvant chemotherapy
has been given, a few options exist: (i) An oral chemotherapy drug called capecitabine may be prescribed for 18 to 24 weeks. (ii) Additional
pembrolizumab after surgery (adjuvant treatment) can reduce the chances of the cancer coming back. (iii) Olaparib may be given for one
year to women who have a BRCA mutation to help lower the chance of the cancer recurring.

 If
TNBC recurs locally, cannot be removed with surgery, and makes the PD-L1 protein, immunotherapy with the drug pembrolizumab along with
chemotherapy is an option. Similarly, for advanced TNBC in which the cancer cells show high levels of gene changes called microsatellite
instability (MSI) or changes in any of the mismatch repair (MMR) genes (MLH1, MSH2, MSH6, and PMS2), immunotherapy with the drug pembrolizumab
might be used. Pembrolizumab might also be an option for TNBC that has a high tumor mutational burden (TMB-H) which is a measure of the
number of gene mutations (changes) inside the cancer cells. Cells that have many gene mutations (a high TMB) might be more likely to
be recognized as abnormal and attacked by the body's immune system. For advanced or recurrent TNBC that has failed at least 2 other
treatment regimens, the antibody-drug conjugate sacituzumab govitecan (Trodelvy) might be an option. Regardless of the stage of TNBC,
participation in a clinical trial of new or investigational treatments for TNBC is also a frequent option since TNBC tends to have a
poor prognosis compared to other types of breast cancer.

 Prostate

 New
agents are being actively developed to treat specific subtypes of prostate cancer. Our approach is to leverage A.I. and biomarker data
to discover subtypes of prostate cancer and treatments for those subtypes of cancer. We believe our approach and our compounds take advantage
of this improved characterization of prostate cancer.

 There
are approved standard of care agents for treating solid tumor prostate cancer, but there are a lack of approved therapeutic options for
non-metastatic castration-resistant prostate cancer ("nmCRPC") patients and castration-resistant disease in metastatic hormone-na ve
prostate cancer ("mHNPC"). The competition we may face in regards to LP-100 and one of the indications of LP-184, specifically
mCRPC, includes without limitation the following drugs:

 Astellas/Pfizer's
 Xtandi (enzalutamide), Johnson & Johnson's Zytiga (abiraterone acetate), Clovis Oncology's Rubraca (rucaparib), GSK's
 Zejula (niraparib), AstraZeneca's Lynparza (olaparib), and Novartis' Pluvicto (Lu-PSMA-617) are approved for treatment
 of metastatic castration-resistant prostate cancer (mCRPC).

 Xtandi
 Zytiga and Androgen Deprivation Therapy ("ADT") to treat mHNPC and nmCRPC, respectively.

 Pfizer
 has tested Talazoparib and Enzalutamide to treat mCRPC

 We
believe LP-184 is unique and has promise for potential use in multiple proposed biomarker profile targeted indications where there are
unmet treatment needs.

 Non
Small Cell Lung Cancer (NSCLC)

 We
believe LP-300 may have an advantage to approved drugs on the market by serving as a well-tolerated agent in combination with
multiple existing standards of care drugs for portions of the NSCLC patient population or female NSCLC patient population. Beyond
traditional chemotherapies (carboplatin/ pemetrexed and/or cisplatin/paclitaxel), NSCLC treatments with potential use for the never
smoker patient population include targeted small molecules and biologics, which include, without limitation, the approved EGFR
inhibitors erlotinib, gefitinib, afatinib, and osimertinib and monoclonal antibody amivantamab-vmjw; the approved ALK inhibitors
brigatinib, ceritinib, crizotinib, alectinib, and ensartinib; the approved MET inhibitor tepotinib; the approved RET inhibitors
pralsetinib and selpercatinib; and the approved immune checkpoint inhibitors pembrolizumab, atezolizumab, and ramucirumab. Many of
these agents are used in specific NSCLC subtypes either as single agents or in various combinations. Many patients with NSCLC
receive treatment with tyrosine kinase inhibitors (TKI's). Most patients treated with 1st or 2nd generation TKI's will
eventually develop resistance to treatment, therefore requiring additional therapeutic options. H002, a fourth generation EGFR
inhibitor entering phase 1/ 2 trials may have potential for treatment of NSCLC subtypes with various EGFR activating mutations that
are common among never smokers and that also underlie resistance to other therapies.

 Government
Regulation

 Government
authorities in the United States at the federal, state and local level and in other countries regulate, among other things, the research,
development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution,
post-approval monitoring and reporting, marketing and export and import of drug and biological products. Generally, before a new drug
can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific
for each regulatory authority, submitted for review and approved by the regulatory authority.

 U.S.
Drug Development

 In
the United States, the FDA regulates drugs under the Food, Drug, and Cosmetic Act ("FDCA"). Drugs also are subject to other
federal, state and local statutes and 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 U.S. requirements at any time during the product development process, approval process or post-market may
subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions, the FDA's refusal
to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, product recalls or market withdrawals,
product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution,
disgorgement and civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.

 Our
drug candidates are considered small molecule drugs and must be approved by the FDA through the NDA process before they may be legally
marketed in the United States. The process generally involves the following:

 completion
 of extensive preclinical studies in accordance with applicable regulations;

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

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

 performance
 of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice ("GCP"),
 requirements and other clinical trial-related regulations to establish substantial evidence of the safety and efficacy of the investigational
 product for each proposed indication;

 submission
 to the FDA of an NDA;

 a
 determination by the FDA within 60 days of its receipt of an NDA to accept the filing for review;

 satisfactory
 completion of a FDA pre-approval inspection of the manufacturing facility or facilities where the drug will be produced to assess
 compliance with cGMP, requirements to assure that the facilities, methods and controls are adequate to preserve the drug or biologic's
 identity, strength, quality and purity;

 potential
 FDA audit of the preclinical study and/or clinical trial sites that generated the data in support of the NDA filing;

 FDA
 review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing
 or sale of the drug in the United States; and

 compliance
 with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy ("REMS"),
 and the potential requirement to conduct post-approval studies.

 The
data required to support an NDA are generated in two distinct developmental stages: preclinical studies and clinical trials. The preclinical
and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any
approvals for any future drug candidates will be granted on a timely basis, or at all.

Studies and IND

studies generally involve laboratory evaluations of drug chemistry, formulation and stability, as well as studies to evaluate toxicity
in animals, which support subsequent clinical testing. The sponsor must submit the results of the preclinical studies, together with
manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as
part of the IND. An IND is a request for authorization from the FDA to administer an investigational product to humans, and must become
effective before human clinical trials may begin.

studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the
potential for adverse events and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject
to federal regulations and requirements, including GLP regulations for safety/toxicology studies. An IND sponsor must submit the results
of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans
for clinical studies, among other things, to the FDA as part of an IND. Some long-term preclinical testing, such as animal tests of reproductive
adverse events and carcinogenicity, may continue 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
trial on 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.

 Clinical
Trials

 The
clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the
supervision of qualified investigators, generally physicians not employed by or under the trial sponsor's control, in accordance
with GCP requirements, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial,
dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy.
Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical
trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks
to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also
approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative, and must
monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed
clinical trial results to public registries.

 A
sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the
clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical
trial to the FDA in support of an NDA. The FDA will accept a well-designed and well-conducted foreign clinical trial not conducted under
an IND if the trial was conducted in accordance with GCP requirements and the FDA is able to validate the data through an onsite inspection,
if deemed necessary, and the practice of medicine in the foreign country is consistent with the United States.

 Clinical
trials in the United States generally are conducted in three sequential phases, known as Phase 1, Phase 2 and Phase 3, and may overlap.

 Phase
 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to
 a single dose and then multiple doses of the drug candidate. The primary purpose of these clinical trials is to assess the metabolism,
 pharmacologic action, tolerability and safety of the drug.

 Phase
 2 clinical trials involve studies in disease-affected patients to determine the dose and dosing schedule required to produce the
 desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible
 adverse effects and safety risks are identified and a preliminary evaluation of efficacy is conducted.

 Phase
 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to
 demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship
 of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo and/or other
 comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing.

 Post-approval
trials, sometimes referred to as Phase 4 clinical trials, are conducted after initial marketing approval. These trials are used to gain
additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate
the performance of Phase 4 clinical trials as a condition of approval of an NDA.

 Progress
reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA and written
IND safety reports must be submitted to the FDA and the investigators for serious and unexpected suspected adverse events, findings from
other studies suggesting a significant risk to humans exposed to the drug, findings from animal or in vitro testing that suggest
a significant risk for human subjects and any clinically important increase in the rate of a serious suspected adverse reaction over
that listed in the protocol or investigator brochure.

 Phase
1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. 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 or patients
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. Additionally, some clinical trials are overseen by an independent group of qualified experts organized
by the clinical trial sponsor, known as a data safety monitoring board or committee. This group provides authorization for whether a
trial may move forward at designated check-points based on access to certain data from the trial. Concurrent with clinical trials, companies
usually complete additional animal safety studies and also must develop additional information about the chemistry and physical characteristics
of the drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
The manufacturing process must be capable of consistently producing quality batches of our drug candidates. Additionally, appropriate
packaging must be selected and tested and stability studies must be conducted to demonstrate that our drug candidates do not undergo
unacceptable deterioration over their labeled shelf life.

 NDA
Review Process

 Following
completion of the clinical trials, data is analyzed to assess whether the investigational product is safe and effective for the proposed
indicated use or uses. The results of preclinical studies and clinical trials are then submitted to the FDA as part of an NDA, along
with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data. In short, the NDA
is a request for approval to market the drug for one or more specified indications and must contain proof of safety and efficacy for
a drug.

 The
application must include both negative and ambiguous results of preclinical studies and clinical trials, as well as positive findings.
Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product's use or from a number
of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient
in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of FDA. FDA approval
of an NDA must be obtained before a drug may be marketed in the United States.

 Under
the Prescription Drug User Fee Act ("PDUFA"), as amended, each NDA must be accompanied by a user fee. The FDA adjusts the
PDUFA user fees on an annual basis. According to the FDA's fiscal year 2022 fee schedule, effective through September 30, 2022,
the user fee for an application requiring clinical data, such as an NDA, was approximately $3.11 million. PDUFA also imposes an annual
program fee for each marketed human drug ($369,413 in 2022) and an annual establishment fee on facilities used to manufacture prescription
drugs. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application
filed by a small business. Additionally, no user fees are assessed on NDAs for products designated as orphan drugs, unless the product
also includes a non-orphan indication.

 The
FDA reviews all submitted NDAs before it accepts them for filing, and may request additional information rather than accepting the NDA
for filing. The FDA must make a decision on accepting an NDA for filing within 60 days of receipt. Once the submission is accepted for
filing, the FDA begins an in-depth review of the NDA. Under the goals and policies agreed to by the FDA under PDUFA, the FDA has 10 months,
from the filing date, in which to complete its initial review of a new molecular-entity NDA and respond to the applicant, and six months
from the filing date of a new molecular-entity NDA designated for priority review. The FDA does not always meet its PDUFA goal dates
for standard and priority NDAs, and the review process is often extended by FDA requests for additional information or clarification.

 Before
approving an NDA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether
they comply with cGMP requirements. The FDA will not approve the product 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.
The FDA also may audit data from clinical trials to ensure compliance with GCP requirements. Additionally, the FDA may refer applications
for novel drug products or drug products which present difficult questions of safety or efficacy to an advisory committee, typically
a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should
be approved and under what conditions, if any. The FDA is not bound by recommendations of an advisory committee, but it considers such
recommendations when making decisions on approval. The FDA likely will reanalyze the clinical trial data, which could result in extensive
discussions between the FDA and the applicant during the review process. After the FDA evaluates an NDA, it will issue an approval letter
or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for
specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application will
not be approved in its present form. A Complete Response Letter usually describes all of the specific deficiencies in the NDA identified
by the FDA. The Complete Response Letter may require additional clinical data, additional pivotal Phase 3 clinical trial(s) and/or other
significant and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. If a Complete Response
Letter is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw
the application. Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.
Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data.

 Orphan
Drugs

 Under
the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition,
which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals
in the United States and for which there is no reasonable expectation that the cost of developing and making the product available in
the United States for this type of disease or condition will be recovered from sales of the product.

 Orphan
drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the identity of the therapeutic
agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten
the duration of the regulatory review and approval process.

 If
a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such
designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market
the same drug for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing
of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety or providing a major
contribution to patient care or in instances of drug supply issues. However, competitors may receive approval of either a different product
for the same indication or the same product for a different indication but that could be used off-label in the orphan indication. Orphan
drug exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval before we do for
the same product, as defined by the FDA, for the same indication we are seeking approval, or if a drug candidate is determined to be
contained within the scope of the competitor's product for the same indication or disease. If one of our products designated as
an orphan drug receives marketing approval for an indication broader than that which is designated, it may not be entitled to orphan
drug exclusivity. Orphan drug status in the European Union has similar, but not identical, requirements and benefits.

 Expedited
Development and Review Programs

 The
FDA has a fast track program that is intended to expedite or facilitate the process for reviewing new drugs that meet certain criteria.
Specifically, new drugs are eligible for fast track designation if they are intended to treat a serious or life-threatening condition
and preclinical or clinical data demonstrate the potential to address unmet medical needs for the condition. Fast track designation applies
to both the product and the specific indication for which it is being studied. The sponsor can request the FDA to designate the product
for fast track status any time before receiving NDA approval, but ideally no later than the pre-NDA meeting with the FDA.

 Any
product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended
to expedite development and review, such as priority review and accelerated approval. Any product is eligible for priority review if
it treats a serious or life-threatening condition and, if approved, would provide a significant improvement in safety and effectiveness
compared to available therapies.

 A
product may also be eligible for accelerated approval, if it treats a serious or life-threatening condition and generally provides a
meaningful advantage over available therapies. In addition, it must demonstrate 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 ("IMM"),
which is reasonably likely to predict an effect on IMM or other clinical benefit. As a condition of approval, the FDA may require that
a sponsor of a drug or biologic receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. If
the FDA concludes that a drug or biologic shown to be effective can be safely used only if distribution or use is restricted, it may
require such post-marketing restrictions as it deems necessary to assure safe use of the product.

a drug may be eligible for designation as a breakthrough therapy if the product is intended, alone or in combination with one or more
other drugs or biologics, to treat a serious or life-threatening condition and preliminary clinical evidence indicates that the product
may demonstrate substantial improvement over currently approved therapies on one or more clinically significant endpoints. The benefits
of breakthrough therapy designation include the same benefits as fast track designation, plus intensive guidance from the FDA to ensure
an efficient drug development program. Fast track designation, priority review, accelerated approval and breakthrough therapy designation
do not change the standards for approval, but may expedite the development or approval process.

 Post-Approval
Requirements

 Following
approval of a new product, the manufacturer and the approved product are subject to continuing regulation by the FDA, including, among
other things, monitoring and record-keeping requirements, requirements to report adverse experiences and comply with promotion and advertising
requirements, which include restrictions on promoting drugs for unapproved uses or patient populations, known as "off-label use,"
and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe legally available drugs
for off-label uses, manufacturers may not market or promote such uses. Prescription drug promotional materials must be submitted to the
FDA in conjunction with their first use. Further, if there are any modifications to the drug, including changes in indications, labeling
or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or NDA supplement,
which may require the development of additional data or preclinical studies and clinical trials.

 The
FDA may also place other conditions on approvals including the requirement for REMS, to assure the safe use of the product. A REMS could
include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient
registries and other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion,
distribution, prescription or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards
or if problems occur following initial marketing.

 The
FDA may withdraw 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 revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks or imposition
of distribution restrictions 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 studies;

 refusal
 of the FDA to approve pending applications or supplements to approved applications;

 applications,
 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. Drugs may be promoted
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.

 Other
U.S. Regulatory Matters

 Manufacturing,
sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in
the United States in addition to the FDA, including the Centers for Medicare & Medicaid Services, other divisions of the Department
of Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission,
the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency, and state and
local governments.

 For
example, in the United States, sales, marketing and scientific and educational programs also must comply with state and federal fraud
and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws. These
laws include the following:

 the
 federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription drug manufacturer (or a party acting
 on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce or reward referrals,
 including the purchase, recommendation, order or prescription of a particular drug, for which payment may be made under a federal
 healthcare program, such as Medicare or Medicaid. Moreover, the ACA 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;

 the
 federal false claims and civil monetary penalties laws, including the civil False Claims Act that can be enforced by private citizens
 through civil whistleblower or qui tam actions, prohibit individuals or entities from, among other things, knowingly presenting,
 or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement
 to avoid, decrease or conceal an obligation to pay money to the federal government;

 the
 Federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), prohibits, among other things, executing
 or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

 HIPAA,
 as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations, also imposes
 obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually
 identifiable health information;

 the
 federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies
 for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program, with specific exceptions,
 to annually report to CMS information regarding payments and other transfers of value to physicians and teaching hospitals as well
 as information regarding ownership and investment interests held by physicians and their immediate family members; and

 analogous
 state and foreign laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements
 and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers,
 state laws that require biotechnology companies to comply with the biotechnology industry's voluntary compliance guidelines
 and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information
 related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, state laws
 that require biotechnology companies to report information on the pricing of certain drug products, and state and foreign laws that
 govern the privacy and security of health information in some circumstances, many of which differ from each other in significant
 ways and often are not preempted by HIPAA, thus complicating compliance efforts.

 Pricing
and rebate programs must also comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990 and
more recent requirements in the ACA. If products are made available to authorized users of the Federal Supply Schedule of the General
Services Administration, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements
under the U.S. Poison Prevention Packaging Act. Manufacturing, sales, promotion and other activities also are potentially subject to
federal and state consumer protection and unfair competition laws.

 The
distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing,
storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

 The
failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or regulatory action. Depending
on the circumstances, failure to meet applicable regulatory requirements can result in significant civil, criminal and administrative
penalties, including damages, fines, disgorgement, individual imprisonment, exclusion from participation in government funded healthcare
programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished
profits and future earnings, injunctions, requests for recall, seizure of products, total or partial suspension of production, denial
or withdrawal of product approvals or refusal to allow a firm to enter into supply contracts, including government contracts.

 U.S.
Patent-Term Restoration and Marketing Exclusivity

 Depending
upon the timing, duration and specifics of FDA approval of any future drug candidates, some of our U.S. patents may be eligible for limited
patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act permits restoration of the patent term of up to five years as
compensation for patent term lost during product development and FDA regulatory review process. Patent-term restoration, however, cannot
extend the remaining term of a patent beyond a total of 14 years from the product's approval date. The patent-term restoration
period is generally one-half the time between the effective date of an IND or the issue date of the patent, whichever is later, and the
submission date of an NDA plus the time between the submission date of an NDA or the issue date of the patent, whichever is later, and
the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise
due diligence. Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must
be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for
any patent term extension or restoration. In the future, we may apply for restoration of patent term for our currently owned or licensed
patents to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors
involved in the filing of the relevant NDA.

exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides a five-year
period of non-patent marketing 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 action of the drug substance. During the exclusivity period, the FDA may not accept
for review an abbreviated new drug application ("ANDA"), or a 505(b)(2) NDA submitted by another company for another version
of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application
may be submitted after four years if it contains a certification of patent invalidity or non-infringement. The FDCA also provides three
years of marketing exclusivity for a NDA, 505(b)(2) NDA or supplement to an existing 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,
for example, new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the conditions of use
associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original
active agent. 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.

 European
Union Drug Development

 Similar
to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory
controls. Although the EU Clinical Trials Directive 2001/20/EC has sought to harmonize the EU clinical trials regulatory framework, setting
out common rules for the control and authorization of clinical trials in the EU, the EU Member States have transposed and applied the
provisions of the Directive differently. This has led to significant variations in the member state regimes. Under the current regime,
before a clinical trial can be initiated it must be approved in each of the EU countries where the trial is to be conducted by two distinct
bodies: the National Competent Authority ("NCA"), and one or more Ethics Committees ("ECs"). Under the current
regime all suspected unexpected serious adverse reactions to the investigated drug that occur during the clinical trial have to be reported
to the NCA and ECs of the Member State where they occurred.

 The
EU clinical trials legislation currently is undergoing a transition process mainly aimed at harmonizing and streamlining clinical-trial
authorization, simplifying adverse-event reporting procedures, improving the supervision of clinical trials and increasing their transparency.
Recently enacted Clinical Trials Regulation EU No 536/2014 ensures that the rules for conducting clinical trials in the EU will be identical.
In the meantime, Clinical Trials Directive 2001/20/EC continues to govern all clinical trials performed in the EU.

 European
Union Drug Review and Approval

 In
the European Economic Area ("EEA"), which is comprised of the 27 Member States of the European Union (including Norway and
excluding Croatia), Iceland and Liechtenstein, medicinal products can only be commercialized after obtaining a Marketing Authorization
("MA"). There are two types of marketing authorizations.

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

 National
 MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are
 available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized
 for marketing in a Member State of the EEA, this National MA can be recognized in another Member States through the Mutual Recognition
 Procedure. If the product has not received a National MA in any Member State at the time of application, it can be approved simultaneously
 in various Member States through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted
 to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as
 the Reference Member State ("RMS"). The competent authority of the RMS prepares a draft assessment report, a draft summary
 of the product characteristics ("SPC"), and a draft of the labeling and package leaflet, which are sent to the other
 Member States (referred to as the Member States Concerned) for their approval. If the Member States Concerned raise no objections,
 based on a potential serious risk to public health, to the assessment, SPC, labeling or packaging proposed by the RMS, the product
 is subsequently granted a national MA in all the Member States (i.e., in the RMS and the Member States Concerned).

 Under
the above described procedures, before granting the MA, EMA or the competent authorities of the Member States of the EEA make an assessment
of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy. Similar to
the U.S. patent term-restoration, Supplementary Protection Certificates ("SPCs") serve as an extension to a patent right
in Europe for up to five years. SPCs apply to specific pharmaceutical products to offset the loss of patent protection due to the lengthy
testing and clinical trials these products require prior to obtaining regulatory marketing approval.

 Coverage
and Reimbursement

 Sales
of our products will depend, in part, on the extent to which our products will be covered by third-party payors, such as government health
programs, commercial insurance, and managed healthcare organizations. There is significant uncertainty related to third-party payor coverage
and reimbursement of newly approved products. In the United States, for example, principal decisions about reimbursement for new products
are typically made by CMS. CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private
third-party payors often follow CMS's decisions regarding coverage and reimbursement to a substantial degree. However, no uniform
policy of coverage and reimbursement for drug products exists. Accordingly, decisions regarding the extent of coverage and amount of
reimbursement to be provided for any of our products will be made on a payor-by-payor basis.

 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. Further, such payors are increasingly challenging the price, examining the medical necessity and
reviewing the cost effectiveness of medical drug candidates. There may be especially significant delays in obtaining coverage and reimbursement
for newly approved drugs. Third-party payors may limit coverage to specific drug candidates on an approved list, known as a formulary,
which might not include all FDA-approved drugs for a particular indication. We may need to conduct expensive pharmaco-economic studies
to demonstrate the medical necessity and cost effectiveness of our products. As a result, the coverage determination process is often
a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each
payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

 In
addition, in most foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements
governing drug pricing and reimbursement vary widely from country to country. For example, the European Union provides options for its
member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and
to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it
may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.
There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow
favorable reimbursement and pricing arrangements for any of our products. Historically, products launched in the European Union do not
follow price structures of the United States and generally prices tend to be significantly lower.

 Healthcare
Reform

 The
United States government, state legislatures, and foreign governments have shown significant interest in implementing cost containment
programs to limit the growth of government-paid healthcare costs, including price-controls, restrictions on reimbursement, and requirements
for substitution of generic products for branded prescription drugs. For example, in March 2010, the Patient Protection and Affordable
Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the "ACA"), was passed
which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the
U.S. pharmaceutical industry. The ACA contains provisions that may reduce the profitability of drug products through increased rebates
for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain
Medicare Part D beneficiaries and annual fees based on pharmaceutical companies' share of sales to federal health care programs.
The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with
the HHS Secretary as a condition for states to receive federal matching funds for the manufacturer's outpatient drugs furnished
to Medicaid patients. The ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers'
rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs from 15.1% of average manufacturer price
("AMP"), to 23.1% of AMP and adding a new rebate calculation for "line extensions" (i.e., new formulations, such
as extended release formulations) of solid oral dosage forms of branded products, as well as potentially impacting their rebate liability
by modifying the statutory definition of AMP. The ACA also expanded the universe of Medicaid utilization subject to drug rebates by requiring
pharmaceutical manufacturers to pay rebates on Medicaid managed care utilization and by enlarging the population potentially eligible
for Medicaid drug benefits. The Centers for Medicare & Medicaid Services ("CMS"), have proposed to expand Medicaid rebate
liability to the territories of the United States as well. Additionally, for a drug product to receive federal reimbursement under the
Medicaid or Medicare Part B programs or to be sold directly to U.S. government agencies, the manufacturer must extend discounts to entities
eligible to participate in the 340B drug pricing program. The required 340B discount on a given product is calculated based on the AMP
and Medicaid rebate amounts reported by the manufacturer.

 Some
of the provisions of the ACA have yet to be implemented, and there have been judicial and Congressional challenges to certain aspects
of the ACA Congress has recently considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress
has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the ACA have passed. On
December 22, 2017, the Tax Cuts and Jobs Act (the "Tax Act") was enacted, which includes a provision repealing, effective
January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying
health coverage for all or part of a year that is commonly referred to as the "individual mandate." The Bipartisan Budget
Act of 2018 (the "BBA"), among other things, amended the ACA, effective January 1, 2019, to close the coverage gap in most
Medicare Part D drug plans. In July 2018, CMS published a final rule permitting further collections and payments to and from certain
ACA-qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of federal district
court litigation regarding the method CMS uses to determine this risk adjustment. On December 14, 2018, a Texas U.S. District Court Judge
ruled that the ACA is unconstitutional in its entirety because the "individual mandate" was repealed by Congress as part
of the Tax Act. On December 18, 2019, the United States Court of Appeal for the Fifth Circuit ruled that the "individual mandate"
of the ACA is unconstitutional, but remanded the case to the U.S. District Court to reconsider whether the entire ACA is unconstitutional.
In June 2021, the Supreme Court concluded that the challenge to the ACA should be dismissed. It is unclear how this decision, subsequent
appeals and decisions, and other efforts to repeal and replace the ACA will impact the ACA.

 Other
legislative changes have been proposed and adopted in the United States since the ACA was enacted. These changes included aggregate reductions
to Medicare payments to providers of up to 2% per fiscal year, effective April 1, 2013, which, due to subsequent legislative amendments,
will stay in effect through 2027 unless additional congressional action is taken. In January 2013, President Obama signed into law the
American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers, and increased the statute
of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in
additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs,
if approved, and accordingly, our financial operations.

there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products,
which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other
things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for drug products. For example, At the state level, legislatures have increasingly passed
legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient
reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures,
and, in some cases, designed to encourage importation from other countries and bulk purchasing.

 Moreover,
the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("MMA"), established the Medicare Part D program
to provide a voluntary prescription drug benefit to Medicare beneficiaries. Under Part D, Medicare beneficiaries may enroll in prescription
drug plans offered by private entities that provide coverage of outpatient prescription drugs. Unlike Medicare Part A and B, Part D coverage
is not standardized. While all Medicare drug plans must give at least a standard level of coverage set by Medicare, 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 products for which we receive marketing approval. However, any negotiated prices for our
products covered by a Part D prescription drug plan likely will be lower than the prices we might otherwise obtain. Moreover, while the
MMA applies only to drug benefits for Medicare beneficiaries, private third-party payors often follow Medicare coverage policy and payment
limitations in setting their own payment rates.

 Employees

 As
of the date of this report, we employ a total of 24 employees. None of our employees are represented by a labor union or covered under
a collective bargaining agreement. We believe that we maintain strong relations with our employees.

 We
also engage outside consultants to assist with research and development, clinical development and regulatory matters, business development,
operations and other functions from time to time.

 Human
Capital Resources.

 Our
employees drive our mission, and we place a high level of importance on employee engagement and corporate culture. Fostering and maintaining
a strong, healthy culture is a key strategic focus for us, and we regularly engage in independent third-party surveys to gauge the satisfaction
and engagement of our team.

 Our
compensation approach is aimed at attracting, retaining, motivating and rewarding superior employees who operate in a highly competitive
and technologically challenging environment. The structure of our compensation aims to balance incentives for both short-term and long-term
performance.

 Some
examples of the benefits we offer include medical insurance, dental insurance, vision insurance, and an unlimited paid-time off policy.

 A
substantial portion of our employees are focused on leading and advancing our drug development, biology and data science efforts. As
we progress our product candidates and grow and expand our team, we intend to continue to place a significant focus on our human capital
resources.

 Available
Information

 We
maintain a website at www.lanternpharma.com. The contents of our website are not incorporated in, or otherwise to be regarded as part
of, this Annual Report on Form 10-K. We make available, free of charge on our website, access to our Annual Report on Form 10-K, our
Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), as soon as reasonably practicable
after we file or furnish them electronically with the Securities and Exchange Commission ("SEC").

 Copies
of our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q, our Current Reports on Form 8-K and other filings we make with
the SEC are also available at the SEC's Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC
at 1-800-SEC-0330 for further information on the Public Reference Room. Our SEC filings are also available on the SEC's website
at www.sec.gov. Statements contained in this Annual Report on Form 10-K concerning the contents of any contract or any other documents
are not necessarily complete. If a contract or document has been filed as an exhibit to this Annual Report on Form 10-K, please see the
copy of the contract or document that has been filed. Each statement in this this Annual Report on Form 10-K relating to a contract or
document filed as an exhibit is qualified in all respects by the filed exhibit.

 Item
1A. Risk Factors

 An
investment in our common stock involves a high degree of risk. You should give careful consideration to the following risk factors, in
addition to general economic and business risks and the other information included in this Annual Report on Form 10-K, including our
financial statements and related notes, before deciding whether to invest in shares of our common stock. The occurrence of any of the
adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results
of operations or prospects. In that case, the trading price of our common stock could decline, and you may lose all or part of your investment.
Additional risks or uncertainties not presently known to us or that we currently deem immaterial may also materially and adversely harm
our business, financial condition, results of operations or prospects.

 Risks
Related to Financial Position and Need for Capital

 We will need substantial additional funding
in the near future, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development
programs or commercialization efforts.

 We anticipate that our expenses
will increase substantially as we continue to develop and begin and continue clinical trials with respect to LP-300, LP-184, LP-284, LP-100
and our other drug candidates; seek to identify and develop additional drug candidates; acquire or in-license other drug candidates or
technologies; seek regulatory and marketing approvals for our drug candidates that successfully complete clinical trials, if any; establish
sales, marketing, distribution and other commercial infrastructure in the future to commercialize various drugs for which we may obtain
marketing approval, if any; require the manufacture of larger quantities of drug candidates for clinical development and, potentially,
commercialization; maintain, expand and protect our intellectual property portfolio; develop, maintain, and expand our RADR
platform; hire and retain additional personnel, such as clinical, quality control and scientific personnel; add operational, financial
and management information systems and personnel, including personnel to support our drug development and help us comply with our obligations
as a public company; and add equipment and physical infrastructure to support our research and development programs.

 We will be required to expend
significant funds in order to advance the development of LP-300, LP-184, LP-284, LP-100 and our other drug candidates. In addition, while
we may seek one or more collaborators for future development of our current drug candidates or any future drug candidates that we may
develop for one or more indications, we may not be able to enter into a partnership or out-license for any of our drug candidates for
such indications on suitable terms, on a timely basis or at all. In any event, our existing cash, cash equivalents and other capital resources
will not be sufficient to fund all of the efforts that we plan to undertake or to fund the completion of development of our drug candidates
or our other preclinical studies. Accordingly, we will be required to obtain further funding through public or private equity offerings,
debt financings, collaborations and licensing arrangements or other sources. We do not have any committed external source of funds. Further
financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative
impact on our financial condition and our ability to pursue our business strategy.

 Based on our anticipated expenditures
and capital commitments as of the date of this report, we believe our existing cash, cash equivalents, and marketable securities as of
December 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the filing
of this Form 10-K for the year ended December 31, 2024. Our estimate as to how long we expect our existing cash, cash equivalents and
other capital resources to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could
use our available capital resources sooner than we currently expect. Further, changing circumstances, some of which may be beyond our
control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds
sooner than planned. Our future funding requirements, both short-term and long-term, will depend on many factors, including:

 the scope, progress, timing, costs and results of preclinical studies and clinical trials of LP-300, LP-184, LP-284, LP-100 and our other drug candidates;

 the costs associated with maintaining, expanding and updating our RADR platform;

 the costs, timing and outcome of seeking regulatory approvals;

 our headcount growth and associated costs as we expand our research and development as well as potentially establish a commercial infrastructure;

 the costs of our licensing or commercialization activities for any of our drug candidates that receive marketing approval to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing drug sales, marketing, distribution and manufacturing capabilities;

 our ability to enter into and the terms and timing of any collaborations, licensing agreements or other arrangements;

 revenue received from commercial sales, if any, of our current and future drug candidates;

 the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against intellectual property related claims;

 the number of future drug candidates that we pursue and their development requirements;

 changes in regulatory policies or laws that may affect our operations;

 changes in physician acceptance or medical society recommendations that may affect commercial efforts;

 the costs of acquiring potential new drug candidates or technology;

 the costs associated with purchasing data for our RADR platform;

 the costs associated with maintaining and expanding our cybersecurity systems; and

 the costs of operating as a public company.

 We
have a limited operating history and have never generated any revenues other than from research grants, which may make it difficult to
evaluate the success of our business to date and to assess our future viability.

 We
were incorporated in November 7, 2013, and to date have been largely focused on organizing and staffing our company, raising capital,
developing the RADR platform and acquiring the rights to, and advancing the development of, our drug candidates, including
conducting preclinical studies and early phase clinical trials on our drug candidates. We have not yet demonstrated an ability to successfully
complete clinical trials, obtain marketing approvals, manufacture drugs on a commercial scale, or arrange for a third party to do so
on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Consequently, predictions about
our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully
developing and commercializing drugs.

 We
expect our financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety
of factors, many of which are beyond our control. We will need to eventually transition from a company with a research and development
focus to a company capable of undertaking commercial activities. We may encounter unforeseen expenses, difficulties, complications and
delays, and may not be successful in such a transition.

 We
have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses
for the foreseeable future and may never achieve or maintain profitability.

 Since
our inception, we have incurred losses. Our net losses were approximately $20,781,000 and $15,962,000 for the years ended December 31,
2024 and 2023, respectively. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable
future. None of our current drug candidates have been approved for marketing in the United States, or in any other jurisdiction, and
may never receive such approval. It could be several years, if ever, before we have a commercialized drug that generates significant
revenues. As a result, we are uncertain when or if we will achieve profitability and, if so, whether we will be able to sustain profitability.
The net losses we incur may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase
substantially over time as we:

 the development of our drug candidates;

 initiate
 preclinical studies and clinical trials for any additional indications for our current drug candidates and any future drug candidates
 that we may pursue;

 to build our portfolio of drug candidates through the acquisition or in-license of additional drug candidates or technologies;

 to develop, maintain, expand and protect our intellectual property portfolio;

 to develop, maintain, and expand our RADR platform;

 pursue
 regulatory approvals for our current and future drug candidates that successfully complete clinical trials;

 ultimately
 establish a sales, marketing, distribution and other commercial infrastructure to commercialize any drug candidate for which we may
 obtain marketing approval;

 hire
 additional clinical, regulatory, scientific and accounting personnel; and

 incur
 additional legal, accounting and other expenses in operating as a public company.

 To
become and remain profitable, we must develop and eventually commercialize one or more drug candidates with significant market potential
or license one or more of our drug candidates to an industry partner. This will require us to be successful in a range of challenging
activities, including completing clinical trials of our drug candidates, publishing our data and findings on our drug candidates with
peer reviewed publications, developing commercial scale manufacturing processes, obtaining marketing approval, manufacturing, marketing
and selling any current and future drug candidates for which we may obtain marketing approval, and satisfying any post-marketing requirements.
We are only in the preliminary stages of most of these activities and, in some cases, have not yet commenced certain of these activities.
We may never succeed in any or all of these activities and, even if we do, we may never generate sufficient revenue to achieve profitability.

 Because
of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of
expenses or when, or if, we will obtain marketing approval to commercialize any of our drug candidates. If we are required by the U.S.
Food and Drug Administration, or FDA, or other regulatory authorities such as the European Medicines Agency, or EMA, to perform studies
and trials in addition to those currently expected, or if there are any delays in the development, or in the completion of any planned
or future preclinical studies or clinical trials of our current or future drug candidates, our expenses could increase and profitability
could be further delayed.

 Even
if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research
and development efforts, expand our business or continue our operations. A decline in the value of our company also could cause investors
to lose all or part of your investment.

 Risks
Related to the Discovery and Development of Drug Candidates

 Disruptions at the FDA and
other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy
key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in
a timely manner or at all, which could negatively impact our business.

 The ability
of the FDA and other government agencies to review and approve new products can be affected by a variety of factors, including
government budget and funding levels, statutory, regulatory, and policy changes, a government agency's ability to hire and retain
key personnel and accept the payment of user fees, and other events that may otherwise affect the government agency's ability to
perform routine functions. Average review times at the FDA and other government agencies have fluctuated in recent years as a result of
these variances. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or modifications to approved
drugs to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. For example, over
the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had
to furlough critical employees and stop critical activities. With the change in presidential administrations in 2025, there is substantial
uncertainty as to how, if at all, the new administration will seek to modify or revise its funding priorities and staffing. The impending
uncertainty could present new challenges or potential opportunities as we navigate the clinical development and approval process for our
product candidates.

 Change
in priorities at the FDA and other government agencies could hinder our ability to develop and commercialize any of our product candidates
in a timely manner.

 The
change in presidential administrations in 2025 led to a change in government priorities that can affect when, if ever, any of our product
candidates may be marketable. On February 6, 2025, for instance, the new presidential administrative ordered a review of all contracting
with, funding of, and awarding of grants to, third parties, including those receiving government funding for drug and biologic development.
 In addition, government funding of other government agencies that fund research and development activities is subject to the political
process, which is inherently fluid and unpredictable. Any delay, modification, or termination of
any government funding to us could result in delay, hamper, or inability of us being able to develop and market any of our product candidates.
Further, HHS announced on February 18, 2025, a change of its priorities that include, among other things, a review of the safety and efficacy
of certain vaccines and psychiatric drugs. In the event that HHS, FDA, or any other government agency announces any additional priorities
affecting our product candidates, the development and commercialization of any of our product candidates could be adversely delayed or
hampered. We continue to monitor the changes from the new presential administration and its impact on our business.

 We
have limited experience in drug discovery and drug development and may not receive regulatory approval to market our drug candidates.

 Prior
to the acquisition of our rescue drug candidates, we were not involved in and had no control over their preclinical and clinical development.
In addition, we rely upon the parties from whom we have acquired our drug candidates from to have conducted such research and development
in accordance with the applicable protocol, legal, regulatory and scientific standards, having accurately reported the results of all
clinical trials conducted prior to our acquisition of the applicable drug candidate, and having correctly collected the data from these
studies and trials. To the extent any of these has not occurred, our expected development time and costs may be increased, which could
adversely affect our prospects for marketing approval of, and receiving any future revenue from, these drug candidates.

 In
the near term, we are dependent on our ability to advance the development of LP-300, LP-184, LP-284, and our other drug candidates. If
we are unable to initiate or complete the clinical development of, obtain marketing approval for or successfully commercialize LP-300,
LP-184, LP-284, and our other drug candidates, either alone or with a collaborator, or if we experience significant delays in doing so,
our business could be substantially harmed.

 We
currently do not have any drugs that have received regulatory approval and may never be able to develop marketable drug candidates. We
are investing a significant portion of our efforts and financial resources in the advancement of our drug candidates and in the development
of our RADR platform. Our prospects are substantially dependent on our ability, or those of any future collaborator,
to develop, obtain marketing approval for and successfully commercialize drug candidates in one or more disease indications.

 The
success of LP-300, LP-184, LP-284, and our other drug candidates will depend on several factors, including the following:

 following
 submission of an Investigational New Drug Application, or IND, with the FDA or any comparable foreign regulatory authority, receiving
 clearance for the conduct of clinical trials of drug candidates and proposed design of future clinical trials;

 initiation,
 progress, timing, costs and results of clinical trials of our drug candidates and potential drug candidates;

 establishment
 of a safety, tolerability and efficacy profile that is satisfactory to the FDA or any comparable foreign regulatory authority for
 marketing approval;

 adequate
 ongoing availability of quality data sources for our RADR platform and raw materials and drug product for clinical
 development and any commercial sales;

 obtaining
 and maintaining patent, trade secret protection and regulatory exclusivity, both in the United States and relevant global markets;

 the
 performance of our future collaborators, if any;

 the
 extent of any required post-marketing approval commitments to applicable regulatory authorities;

 establishment
 of supply arrangements with third-party raw materials suppliers and manufacturers;

 establishment
 of arrangements with third-party manufacturers to obtain finished drug product that is appropriately packaged for sale;

 protection
 of our rights in our intellectual property portfolio;

 successful
 launch of commercial sales following any marketing approval;

 a
 continued acceptable safety profile following any marketing approval;

 commercial
 acceptance by patients, the medical community and third-party payors; and

 our
 ability to compete with other therapies.

 Many
of these factors are beyond our control, including the results of clinical trials, the time required for the FDA or any comparable foreign
regulatory authorities to review any regulatory submissions we may make, potential threats to our intellectual property rights and the
manufacturing, marketing and sales efforts of any future collaborator. If we are unable to develop, receive marketing approval for and
successfully commercialize our drug candidates, on our own or with any future collaborator or experience delays as a result of any of
these factors or otherwise, our business could be substantially harmed. The regulatory approval processes of the FDA and comparable foreign
authorities are lengthy, time consuming, expensive and inherently unpredictable, and if we are ultimately unable to obtain regulatory
approval for our drug candidates, our business will be substantially harmed.

 The
time required to obtain approval by the FDA and comparable foreign authorities is unpredictable but can take many years following the
commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.
The results of preclinical studies and early clinical trials of our drug candidates may not be predictive of the results of later-stage
clinical trials. Drug candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having
progressed through preclinical studies and initial clinical trials. It is not uncommon for companies in the biotechnology and pharmaceutical
industries to suffer significant setbacks in advanced clinical trials due to nonclinical findings made while clinical studies were underway
and safety or efficacy observations made in clinical studies, including previously unreported adverse events. Our future clinical trial
results may not be successful, and notwithstanding any potential promising results in earlier studies, we cannot be certain that we will
not face similar setbacks. The historical failure rate for drug candidates in our industry is high. In addition, approval policies, regulations,
or the type and amount of clinical data necessary to gain approval may change during the course of a drug candidate's clinical
development and may vary among jurisdictions. We have not obtained final regulatory approval for any drug candidate and it is possible
that none of our existing drug candidates or any drug candidates we may seek to develop in the future will ever obtain regulatory approval.

 Our
drug candidates could fail to receive regulatory clearance or marketing approval for many reasons, including the following:

 the
 FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials, including,
 but not limited to, the use of genomic or biomarker signatures to identify patients that may respond to drug efficacy;

 we
 may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a drug candidate is
 safe and effective for its proposed indication;

 we
 may be unable to identify and recruit a sufficient number of patients with relevant genomic or biomarker signatures or other specified
 enrollment criteria in order to conduct clinical trials on our drug candidates;

 the
 results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory
 authorities for approval;

 the
 FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical
 trials;

 the
 data collected from clinical trials of our drug candidates may not be sufficient to support the submission of a New Drug Application,
 or NDA, or other submission or to obtain regulatory approval in the United States or elsewhere;

 the
 FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers
 with which we contract for clinical and commercial supplies; and

 the
 approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering
 our clinical data insufficient for approval.

 We
have not previously completed all clinical trials for any of our drug candidates. Consequently, we may not have the necessary capabilities,
including adequate staffing, to successfully manage the execution and completion of any clinical trials we initiate in a way that leads
to our obtaining marketing approval for our drug candidates in a timely manner, or at all. This lengthy approval process as well as the
unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our drug candidates,
which would significantly harm our business, results of operations and prospects.

 In
addition, even if we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited
indications than we request, may not approve the price we intend to charge for our drugs, may grant approval contingent on the performance
of costly post-marketing clinical trials, may approve a drug candidate with a label that does not include the labeling claims necessary
or desirable for the successful commercialization of that drug candidate or may restrict its distribution. Any of the foregoing restrictions
or requirements could materially harm the commercial prospects for our drug candidates.

 We
have not previously submitted a new drug application (an "NDA") to the FDA or similar drug approval filings to comparable
foreign authorities, for any drug candidate, and we cannot be certain that any of our drug candidates will be successful in clinical
trials or receive regulatory approval. Further, our drug candidates may not receive regulatory approval even if they are successful in
clinical trials. If we do not receive regulatory approvals for our drug candidates, we may not be able to continue our operations. Even
if we successfully obtain regulatory approvals to market one or more of our drug candidates, our revenues will be dependent, in part,
upon the size of the markets in the territories for which we gain regulatory approval and have commercial rights. If the markets for
patients that we are targeting for our drug candidates are not as significant as we estimate, or if the price we charge for our drug
candidate is too high, we may not generate significant revenues from sales of such drugs, if approved.

 We
plan to seek regulatory approval to commercialize our drug candidates both in the United States and the European Union and in additional
foreign countries. While the scope of regulatory approval is similar in other countries, to obtain separate regulatory approval in many
other countries we must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and
governing, among other things, clinical trials and possible limitations placed upon commercial sales, pricing and distribution of our
drug candidates, and we cannot predict success in these jurisdictions.

 Our
business strategy to rescue previously failed drug candidates may not be successful, and important issues relating to safety and efficacy
remain to be resolved for all of our drug candidates. Our strategy also involves risks and uncertainties that differ from other biotechnology
companies that focus solely on new drug candidates that do not have a history of failed clinical trials.

 Our
drug candidate portfolio includes small molecules that others have tried, but failed, to develop into an approved commercialized drug.
Our strategy to rescue previously failed drug candidates may not be successful, and the use of the term "drug rescue," "rescuing,"
or words of similar meaning in this report should not be construed to mean that our RADR platform has resolved all issues
of safety and/or efficacy for any of our drug candidates. Issues of safety and efficacy for any drug candidate may only be determined
by the U.S. FDA or other applicable regulatory authorities in jurisdictions outside the United States.

 Our
business strategy includes a focus on leveraging A.I. to streamline the drug development process and to identify patients that will benefit
from drug candidates that other biotechnology or pharmaceutical companies have abandoned or shelved after initiating clinical trials
under an IND application filed with the FDA, including candidates that have failed to achieve statistical significance on the original
endpoints established in the clinical trials. We use our RADR platform to assess drug candidates together with big data
sources of information to both target and evaluate sub-populations and identify new therapeutic indices and gene signatures that will
potentially correlate with drug efficacy and patient response to treatment. While we have not yet successfully received regulatory or
marketing approval for any of our drug candidates, and while we believe that our approach has the potential to reduce the cost and time
of drug development through the identification and selection of patient populations more likely to respond to therapy, our strategy involves
risks and uncertainties that differ from other biotechnology companies that focus solely on new drug candidates that do not have a history
of failed clinical development. These risks and uncertainties include, but are not limited to, the following:

 The
 remaining term of the initial patents filed with respect to a rescued and repositioned drug candidate may be significantly less than
 the patent term for a newly discovered drug candidate;

 Potential
 out-licensees, alliance partners and collaborators may view a rescued and repositioned drug candidate with more skepticism because
 of its history of failed clinical trials, thereby requiring a higher level of additional data and further explanations of mechanisms
 of action in order to overcome this skepticism and obtain commercially reasonable terms for future development or collaboration;

 Key
 personnel and institutional knowledge relating to a rescued and repositioned drug candidate may no longer be available for us;

 The
 current standard of care in the targeted therapeutic indication for the rescued and repositioned drug candidate may be different
 than the standard of care that existed during the candidate's last clinical trial, which will require more time and resources
 from us to reassess and redesign the regulatory development path for the rescued and repositioned drug candidate; and

 The
 rescued and repositioned drug candidate may be perceived to be in an "older" therapeutic focus area of oncology, thereby
 generating less enthusiasm and support compared to therapeutic focus areas of oncology that may be perceived as more recent.

 We
may depend on enrollment of patients with specific genomic or biomarker signatures in our clinical trials in order for us to continue
development of our drug candidates. If we are unable to enroll patients with specific genomic or biomarker signatures in our clinical
trials, our research, development and commercialization efforts could be adversely affected.

 The
timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient
number of patients with genomic or biomarker signatures we have identified and who remain in the study until its conclusion. We may experience
difficulties in patient enrollment in our clinical trials for a variety of reasons. Patient enrollment is affected by many factors including
the size and nature of the patient population with the specific genomic or biomarker signature we have identified, the proximity of patients
to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, the size of the patient population required
for analysis of the trial's primary endpoints, the proximity of patients to study sites, our ability to recruit clinical trial
investigators with the appropriate competencies and experience, our ability to obtain and maintain patient consents, the risk that patients
enrolled in clinical trials will drop out of the trials before completion, and competing clinical trials and clinicians' and patients'
perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs
that may be approved for the indications we are investigating. We will compete with other pharmaceutical companies for clinical sites,
physicians and the limited number of patients who fulfill the stringent requirements for participation in oncology clinical trials. Also,
due to the confidential nature of clinical trials, we do not know how many of the eligible patients may be enrolled in competing studies
and who are consequently not available to us for our clinical trials. Our clinical trials may be delayed or terminated due to the inability
to enroll enough patients. The delay or inability to meet planned patient enrollment may result in increased costs and delay or termination
of our trials, which could have a harmful effect on our ability to develop drugs.

 Delays
in clinical testing could result in increased costs to us and delay our ability to generate revenue.

 There
can be no assurance that the FDA or other regulatory authorities will accept our planned or future trial designs for our drug candidates.
We may experience delays in our clinical trials and we do not know whether planned clinical trials will begin on time, need to be redesigned,
enroll patients on time or be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays
related to:

 obtaining
 regulatory clearance to commence a trial;

 reaching
 agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which
 can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

 obtaining
 institutional review board, or IRB, approval at each site;

 recruiting
 suitable patients to participate in a trial;

 identifying
 clinical sites with adequate infrastructure (including data collection) to conduct the trial;

 clinical
 sites deviating from trial protocol or dropping out of a trial;

 addressing
 patient safety concerns that arise during the course of a trial;

 having
 patients complete a trial or return for post-treatment follow-up;

 adding
 a sufficient number of clinical trial sites; or

 manufacturing
 sufficient quantities and quality of a drug candidate for use in clinical trials.

 We
may also 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 drug candidates, including:

 we
 may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials;

 we
 may not have the ability to test patients for our clinical trials that require a specific genomic or biomarker signature in order
 to qualify for enrollment;

 clinical
 trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct
 additional clinical trials or abandon drug development programs;

 the
 number of patients required for clinical trials of our drug 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;

 our
 third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner,
 or at all;

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

 the
 supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient
 or inadequate;

 regulators
 may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; and

 any
 future collaborators that conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they
 view as advantageous to themselves but that are suboptimal for us.

 If
we are required to conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate,
if we are unable to successfully complete clinical trials of our drug 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:

 incur
 unplanned costs;

 be
 delayed in obtaining marketing approval for our drug candidates or not obtain marketing approval at all;

 obtain
 marketing approval in some countries and not in others;

 obtain
 marketing approval for indications or patient populations that are not as broad as intended or desired;

 obtain
 marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

 be
 subject to additional post-marketing testing requirements; or

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

 Furthermore,
we rely and intend to rely in the future on CROs, cancer research centers and clinical trial sites to ensure the proper and timely conduct
of our clinical trials and we intend to have agreements governing their committed activities. They may not perform as required or we
may face competition from other clinical trials being conducted by other pharmaceutical companies.

 We
could encounter delays if a clinical trial is suspended or terminated by us, by the Institutional Review Board or IRB of the institutions
in which such trials are being conducted, by the Data Safety Monitoring Board, or DSMB, for such trial or by the FDA or other regulatory
authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the
clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial
site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side
effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of
adequate funding to continue the clinical trial.

 Further,
conducting clinical trials in foreign countries, as we may do for our current and future drug candidates, presents additional risks that
may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical
protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated
with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries.

 If
we experience delays in the completion of, or termination of, any clinical trial of our drug candidates, the commercial prospects of
our drug candidates will be harmed, and our ability to generate revenues from any of these drug candidates will be delayed. In addition,
any delays in completing our clinical trials will increase our costs, slow down our drug candidate development and approval process and
jeopardize our ability to commence drug sales and generate revenues. Any of these occurrences may harm our business, financial condition
and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical
trials may also ultimately lead to the denial of regulatory approval of our drug candidates.

 Our
drug candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit
the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.

 Undesirable
side effects caused by our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could
result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. It is possible that there may be side effects associated with any of our
drug candidates. In such an event, we, the FDA, the IRBs at the institutions in which our studies are conducted, or the DSMB could suspend
or terminate our clinical trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny
approval of our drug candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment
or the ability of enrolled patients to complete the clinical trial or result in potential product liability claims. In addition, these
side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel
using our drug candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our
drug candidates. Inadequate training in recognizing or managing the potential side effects of our drug candidates could result in patient
injury or death. Any of these occurrences may harm our business, financial condition and prospects significantly.

if one or more of our drug candidates receives marketing approval, and we or others later identify undesirable side effects caused by
such drugs, a number of potentially significant negative consequences could result, including:

 regulatory
 authorities may withdraw approvals of such drugs;

 we
 may be required to recall a drug or change the way such a drug is administered to patients;

 additional
 restrictions may be imposed on the marketing or distribution of the particular drug or the manufacturing processes for the drug or
 any component thereof;

 regulatory
 authorities may require additional warnings on the label, such as a "black box" warning or contraindication;

 we
 may be required to implement Risk Evaluation and Mitigation Strategies, or REMS, or create a medication guide outlining the risks
 of such side effects for distribution to patients;

 we
 could be sued and held liable for harm caused to patients;

 our
 drug may become less competitive; and

 our
 reputation may suffer.

 Any
of these events could prevent us from achieving or maintaining market acceptance of the particular drug candidate or for particular indications
of a drug candidate, if approved, and could significantly harm our business, results of operations and prospects. Our approach to the
discovery and development of drug candidates based on our RADR platform is innovative and in the early stages of development;
and we do not know whether we will be able to develop any drugs of commercial value.

 We
are leveraging our RADR platform in an attempt to create a pipeline of drug candidates using biomarker identification
and patient stratification for the development of oncology drugs. While we believe that applying our RADR platform to
drugs that have failed, been abandoned or otherwise failed to meet clinical endpoints and then developing a precision oncology approach
that identifies the mechanism of action, potential combination drug usage and potentially responsive patient population is a powerful
strategy, our approach is both innovative and in the early stages of development. Because our approach is both innovative and in the
early stages of development, the cost and time needed to develop our drug candidates is difficult to predict, and our efforts may not
result in the successful discovery and development of commercially viable medicines. We may also be incorrect about the effects of our
drug candidates on the diseases of our defined patient populations, which may limit the utility of our approach or the perception of
the utility of our approach. Furthermore, our estimates of our defined patient populations available for study and treatment may be lower
than expected, which could adversely affect our ability to conduct clinical trials and may also adversely affect the size of any market
for medicines we may successfully commercialize. Our approach may not result in time savings, higher success rates or reduced costs as
we expect it to, and if not, we may not attract collaborators or develop new drugs as quickly or cost effectively as expected and therefore
we may not be able to commercialize our approach as originally expected.

 Our
RADR platform may fail to help us discover and develop additional potential drug candidates.

 Any
drug discovery or drug development that we are conducting using our RADR platform may not be successful in identifying
compounds that have commercial value or therapeutic utility. Our RADR platform may initially show promise in identifying
potential drug candidates, yet fail to yield viable drug candidates for clinical development or commercialization for a number of reasons,
including:

 research
 programs to identify new drug candidates will require substantial technical, financial and human resources, and we may be unsuccessful
 in our efforts to identify new drug candidates. If we are unable to identify suitable additional compounds for preclinical and clinical
 development, our ability to develop drug candidates and obtain product revenues in future periods could be compromised, which could
 result in significant harm to our financial position and adversely impact our stock price;

 compounds
 identified through our RADR platform may not demonstrate efficacy, safety or tolerability;

 the
 data available for our RADR platform that seeks to correlate genomic or biomarker signatures with certain cancers
 may be influenced by the race of the patient which may limit the efficacy of our drug candidates;

 potential
 drug candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are
 unlikely to receive marketing approval and achieve market acceptance;

 competitors
 may develop alternative therapies that render our potential drug candidates non-competitive or less attractive; or

 a
 potential drug candidate may not be capable of being produced at an acceptable cost.

 Any
failure by us to comply with existing regulations could harm our reputation and operating results.

 We
will be subject to extensive regulation by U.S. federal and state and foreign governments in each of the markets where we intend to sell
LP-300, LP-184, LP-284, and LP-100 if and after they are approved. For example, we will have to adhere to all regulatory requirements
including the FDA's current GCPs, Good Laboratory Practice, or GLP, and GMP requirements, or that of applicable foreign regulatory
authorities. If we fail to comply with applicable regulations, including FDA pre-or post- approval cGMP requirements, then the FDA or
other foreign regulatory authorities could sanction us. Even if a drug is FDA-approved, regulatory authorities may impose significant
restrictions on a drug's indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing studies.

 Any
action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses,
divert our management's attention from the operation of our business and damage our reputation. We will need to expend significant
resources on compliance efforts and such expenses are unpredictable and might adversely affect our results.

 The
FDA's and other regulatory authorities' policies may change and additional government regulations may be enacted that could
prevent, limit or delay regulatory approval of our drug candidates. For example, in December 2016, the 21st Century Cures Act, or Cures
Act, was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and spur innovation, but
its ultimate implementation is unclear. If we are slow or unable to adapt to changes in existing requirements or the adoption of new
requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have
obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and
results of operations. In addition, the new 2025 U.S. presidential administration has implemented or threatened reductions in force and
work stoppages across several U.S. federal agencies. Any such
reductions or stoppages at the FDA or other federal agencies could delay communications, responses and other agency processes and activities
relating to any of our product candidates, which could negatively impact our business. In addition, the new presidential administration
may institute policies, communications or programs that could negatively impact the biotechnology and pharmaceutical sectors, drug candidates,
and our ability to obtain additional funding.

 In
addition, we cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative
or executive action, either in the United States or abroad. If future legislation or administrative or executive actions impose restrictions
on FDA's ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.
In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or
if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve
or sustain profitability.

 We
may be subject to extensive regulations outside the United States and may not obtain marketing approvals for drugs in Europe and other
jurisdictions.

 In
addition to regulations in the United States, should we or our collaborators pursue marketing approvals for LP-300, LP-184, LP-284 and
our other drug candidates internationally, we and our collaborators will be subject to a variety of regulations in other jurisdictions
governing, among other things, clinical trials and any commercial sales and distribution of our drugs. Whether or not we, or our collaborators,
obtain applicable FDA regulatory clearance and marketing approval for a drug, we must obtain the requisite approvals from regulatory
authorities in foreign countries prior to the commencement of clinical trials or marketing of the drug in those countries. The requirements
and process governing the conduct of clinical trials, drug licensing, pricing and reimbursement vary from country to country.

 Subject
to obtaining necessary clinical data, we intend to pursue marketing approvals for LP-300, LP-184, LP-284 and our other drug candidates
in Europe and other jurisdictions outside the United States with collaborative partners. The time and process required to obtain regulatory
approvals and reimbursement in Europe and other jurisdictions may be different from those in the United States regulatory and approval
in one jurisdiction does not ensure approvals in any other jurisdiction; however, negative regulatory decisions in any jurisdiction may
have a negative impact on the regulatory process in other jurisdictions.

 Today,
the United Kingdom is outside the European Union and mostly no longer subject to its rules. Significant portions of the regulatory framework
in the United Kingdom have been derived from European Union directives and regulations. Any delay in obtaining, or an inability to obtain,
any marketing approvals, would prevent us from commercializing our drug candidates in the United Kingdom and/or the European Union and
restrict our ability to generate revenue and achieve and sustain profitability. If any of these outcomes occur, we may be forced to restrict
or delay efforts to seek regulatory approval in the United Kingdom and/or European Union for our drug candidates, which could materially
and adversely affect our business.

 If
we are found in violation of federal or state "fraud and abuse" laws, we may be required to pay a penalty and/or be suspended
from participation in federal or state health care programs, which may adversely affect our business, financial condition and results
of operations.

 In
the United States, we will be subject to various federal and state health care "fraud and abuse" laws, including anti-kickback
laws, false claims laws and other laws intended to reduce fraud and abuse in federal and state health care programs, which could affect
us, particularly upon successful commercialization of our drugs in the United States. The federal Anti-Kickback Statute makes it illegal
for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive,
offer or pay any remuneration that is intended to induce the referral of business, including the purchase, order or prescription of a
particular drug for which payment may be made under a federal health care program, such as Medicare or Medicaid. Under federal government
regulations, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback Statute. Although we seek
to structure our business arrangements in compliance with all applicable requirements, these laws are broadly written, and it is often
difficult to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices
may be challenged under the federal Anti-Kickback Statute. False claims laws prohibit anyone from knowingly and willfully presenting
or causing to be presented for payment to third-party payers, including government payers, claims for reimbursed drugs or services that
are false or fraudulent, claims for items or services that were not provided as claimed, or claims for medically unnecessary items or
services. Cases have been brought under false claims laws alleging that off-label promotion of pharmaceutical drugs or the provision
of kickbacks has resulted in the submission of false claims to governmental health care programs. Under the Health Insurance Portability
and Accountability Act of 1996, we are prohibited from knowingly and willfully executing a scheme to defraud any health care benefit
program, including private payers, or 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 health care benefits, items or services.
Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and/or exclusion or suspension
from federal and state health care programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In
addition, private individuals have the ability to bring actions on behalf of the government under the federal False Claims Act as well
as under the false claims laws of several states.

 Many
states have adopted laws similar to the federal anti-kickback statute, some of which apply to the referral of patients for health care
services reimbursed by any source, not just governmental payers. Neither the government nor the courts have provided definitive guidance
on the application of fraud and abuse laws to our business. Law enforcement authorities are increasingly focused on enforcing these laws,
and if we are found in violation of one of these laws, we could be required to pay a penalty and could be suspended or excluded from
participation in federal or state health care programs, and our business, results of operations and financial condition may be adversely
affected. We may be unable to maintain sufficient clinical trial liability insurance.

 Our
inability to obtain and retain sufficient clinical trial liability insurance at an acceptable cost to protect against potential liability
claims could prevent or inhibit our ability to conduct clinical trials for drug candidates we develop.

 We
have secured clinical trial liability insurance coverage regarding our clinical trials of LP-300, LP-184 and LP-284 and will be securing
clinical trial liability insurance coverage before commencing patient enrollment for our other future clinical trials. Any claim that
may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our
insurance or that is in excess of the limits of our insurance coverage. We expect we will supplement our clinical trial coverage with
product liability coverage in connection with the potential commercial launch of our drug candidates; however, we may be unable to obtain
such increased coverage on acceptable terms or at all. If we are found liable in a clinical trial lawsuit or a product liability lawsuit
in the future, we will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations
or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

 The
FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

 If
we are found to have improperly promoted off-label uses of our drugs or drug candidates, if approved, we may become subject to significant
liability. Such enforcement has become more common in the industry. The FDA and other regulatory agencies strictly regulate the promotional
claims that may be made about prescription drug products, such as our drug candidates, if approved. In particular, a drug may not be
promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the drug's approved labeling.
If we receive marketing approval for our drug candidates for our proposed indications, physicians may nevertheless use our drugs for
their patients in a manner that is inconsistent with the approved label, if the physicians personally believe in their professional medical
judgment it could be used in such manner. However, if we are found to have promoted our drugs for any off-label uses, the federal government
could levy civil, criminal and/or administrative penalties, and seek fines against us. The FDA or other regulatory authorities could
also request that we enter into a consent decree or a corporate integrity agreement, or seek a permanent injunction against us under
which specified promotional conduct is monitored, changed or curtailed. If we cannot successfully manage the promotion of our drug candidates,
if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

 We
may not experience a faster development or regulatory review or approval process with potential Fast Track designation.

 If
a drug is intended for the treatment of a serious condition and nonclinical or clinical data demonstrate the potential to address unmet
medical need for this condition, a drug sponsor may apply for FDA Fast Track designation. If we seek Fast Track designation for a drug
candidate, we may not receive it from the FDA. However, even if we receive Fast Track designation, Fast Track designation does not ensure
that we will receive marketing approval or that approval will be granted within any particular timeframe. We may not experience a faster
development or regulatory review or approval process with Fast Track designation compared to conventional FDA procedures. In addition,
the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development
program. Fast Track designation alone does not guarantee qualification for the FDA's priority review procedures.

 Risks
Related to Commercialization of Our Drug Candidates

 Even
if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing one or more
of our drug candidates.

 Even
if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and
uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our drug candidates. If we are not
able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our drug candidates,
and our ability to generate revenue will be materially impaired.

 Our
drug candidates and the activities associated with their development and commercialization, including their design, testing, manufacture,
safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, export and import are subject
to comprehensive regulation by the FDA and other regulatory agencies in the United States and by the EMA and similar regulatory authorities
outside of the United States. Failure to obtain marketing approval for a drug candidate will prevent us from commercializing the drug
candidate. We have not submitted an application for or received marketing approval for any of our drug candidates in the United States
or in any other jurisdiction.

 We
have only limited experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party
clinical research organizations or other third-party consultants or vendors to assist us in this process. 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 drug candidate's safety and efficacy. Securing marketing approval also requires the submission of information
about the drug manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our drug candidates
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 our obtaining marketing approval or prevent or limit commercial use. New cancer drugs frequently are
indicated only for patient populations that have not responded to an existing therapy or have relapsed. If any of our drug candidates
receives marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales of the
drug.

 The
process of obtaining marketing approvals, both in the United States and abroad, is 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 drug candidates
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 drug 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 is insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying
interpretations of the data obtained from preclinical studies and clinical trials could delay, limit or prevent marketing approval of
a drug candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments
that render the approved drug not commercially viable.

 If
our drugs do not gain market acceptance, our business will suffer because we might not be able to fund future operations.

 A
number of factors may affect the market acceptance of our drugs or any other products we develop or acquire, including, among others:

 the
 price of our drugs relative to other products for the same or similar treatments;

 the
 perception by patients, physicians and other members of the health care community of the effectiveness and safety of our drugs for
 their indicated applications and treatments;

 our
 ability to fund our sales and marketing efforts; and

 the
 effectiveness of our sales and marketing efforts.

 If
our drugs do not gain market acceptance, we may not be able to fund future operations, including developing, testing and obtaining regulatory
approval for new drug candidates and expanding our sales and marketing efforts for our approved drugs, which would cause our business
to suffer.

 We
may rely on orphan drug status to commercialize some of our drug candidates, and even if orphan drug status is approved, such approval
may not confer marketing exclusivity or other commercial advantages or expected commercial benefits.

 We
may rely on orphan drug exclusivity for our drug candidates. In the United States, orphan drug designation entitles a party to financial
incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In addition, if
a drug that has orphan drug designation subsequently receives the first FDA marketing approval for the disease for which it has such
designation, the drug is entitled to orphan drug exclusivity. Orphan drug exclusivity in the United States provides that the FDA may
not approve any other applications, including a full NDA, to market the same drug for the same indication for seven years, and except
in limited circumstances the applicable exclusivity period is ten years in Europe. The European exclusivity period can be reduced to
six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market
exclusivity is no longer justified.

 Even
if we, or any future collaborators, obtain orphan drug designation for a drug candidate, we, or they, may not be able to obtain or maintain
orphan drug exclusivity for that drug candidate. We may not be the first to obtain marketing approval of any drug candidate for which
we have obtained orphan drug designation for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical
products, and it is possible that another company also holding orphan drug designation for the same drug candidate will receive marketing
approval for the same indication before we do. If that were to happen, our applications for that indication may not be approved until
the competing company's period of exclusivity expires. In addition, exclusive marketing rights in the United States may be limited
if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the
request for designation was materially defective or if we are unable to assure sufficient quantities of the drug to meet the needs of
patients with the rare disease or condition. Further, even if we, or any future collaborators, obtain orphan drug exclusivity for a drug,
that exclusivity may not effectively protect the drug from competition because different drugs with different active moieties may be
approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the same
active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer,
more effective or makes a major contribution to patient care or the manufacturer of the drug with orphan exclusivity is unable to maintain
sufficient drug quantity. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives
the drug any advantage in the regulatory review or approval process, nor does it prevent competitors from obtaining approval of the same
drug candidate as ours for indications other than those in which we have been granted orphan drug designation.

 On
August 3, 2017, the U.S. Congress passed the FDA Reauthorization Act of 2017, or FDARA. FDARA, among other things, codified the FDA's
preexisting regulatory interpretation, to require that a drug sponsor demonstrate the clinical superiority of an orphan drug that is
otherwise the same as a previously approved drug for the same rare disease in order to receive orphan drug exclusivity. The legislation
reverses prior precedent holding that the Orphan Drug Act unambiguously requires that the FDA recognize the orphan exclusivity period
regardless of a showing of clinical superiority. Congress or the FDA may further reevaluate the Orphan Drug Act and its regulations and
policies. We do not know if, when or how congress or the FDA may change the orphan drug regulations and policies in the future, and it
is uncertain how any changes might affect our business. Depending on what changes congress or the FDA may make to orphan drug regulations
and policies, our business could be adversely impacted.

 A
breakthrough therapy designation by the FDA for our drug candidates may not lead to a faster development or regulatory review or approval
process, and it does not increase the likelihood that our drug candidates will receive marketing approval.

 We
may seek a breakthrough therapy designation for some of our drug candidates. 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. For drugs and biologics that have been designated
as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient
path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough
therapies by the FDA are also eligible for accelerated approval.

 Designation
as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our drug candidates meets the criteria
for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. Even if we receive
Breakthrough Therapy designation, the receipt of such designation for a drug candidate may not result in a faster development process,
review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval
by the FDA. In addition, even if one or more of our drug candidates qualify as breakthrough therapies, the FDA may later decide that
the drugs no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

 A
Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process.

 We
have obtained Fast Track Designation for LP-184 (STAR-001) and we may seek additional Fast Track designations for our drug candidates.
If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address
unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation. The FDA has broad discretion whether
or not to grant this designation, so even if we believe a particular drug candidate is eligible for this designation, we cannot assure
you that the FDA would decide to grant it. Even if we do receive Fast Track designation, we may not experience a faster development process,
review or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track designation if it believes that the designation
is no longer supported by data from our clinical development program.

 Failure
to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad.

 In
order to market and sell our drugs in the European Union and many other foreign jurisdictions, we or our potential third-party collaborators
must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies
among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required
to obtain FDA marketing approval. The regulatory approval process outside of the United States generally includes all of the risks associated
with obtaining FDA approval. In addition, in many countries outside of the United States, it is required that the drug be approved for
reimbursement before the drug can be approved for sale in that country. We or our potential third-party collaborators may not obtain
approvals from regulatory authorities outside of the United States on a timely basis, if at all. Approval by the FDA does not ensure
approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside of the United
States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. However, a failure or delay
in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries. We may not be
able to file for marketing approvals and may not receive necessary approvals to commercialize our drugs in any market.

 If
we are required by the FDA to obtain approval of a companion diagnostic in connection with approval of a therapeutic drug candidate,
and we do not obtain or face delays in obtaining FDA approval of a diagnostic device, we will not be able to commercialize the drug candidate
and our ability to generate revenue will be materially impaired.

 According
to FDA guidance, if the FDA determines that a companion diagnostic device is essential to the safe and effective use of a novel therapeutic
drug or indication, the FDA generally will not approve the therapeutic drug or new therapeutic drug indication if the companion diagnostic
is not also approved or cleared for that indication. Under the Federal Food, Drug, and Cosmetic Act, or FDCA, companion diagnostics are
regulated as medical devices, and the FDA has generally required companion diagnostics intended to select the patients who will respond
to cancer treatment to obtain Premarket Approval, or a PMA, for the diagnostic. The PMA process, including the gathering of clinical
and preclinical data and the submission to and review by the FDA, involves a rigorous premarket review during which the applicant must
prepare and provide the FDA with reasonable assurance of the device's safety and effectiveness and information about the device
and its components regarding, among other things, device design, manufacturing and labeling. A PMA is not guaranteed and may take considerable
time, and the FDA may ultimately respond to a PMA submission with a "not approvable" determination based on deficiencies
in the application and require additional clinical trial or other data that may be expensive and time-consuming to generate and that
can substantially delay approval. As a result, if we are required by the FDA to obtain approval of a companion diagnostic for a therapeutic
drug candidate, and we do not obtain or there are delays in obtaining FDA approval of a diagnostic device, we may not be able to commercialize
the drug candidate on a timely basis or at all and our ability to generate revenue will be materially impaired.

 While
it is possible that one or more of our drug candidates may require a companion diagnostic to select the patients who will likely respond
to a cancer therapy involving one of our drug candidates that would require a PMA for the companion diagnostic as a condition to obtaining
marketing approval from the FDA, it is too early in our drug candidates development to identify which drug candidate, if any, would require
a PMA.

 Any
drug candidate that we obtain marketing approval for could be subject to post-marketing restrictions or withdrawal from the market and
we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems
with our drugs, when and if any of them are approved.

 Any
drug candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling,
advertising and promotional activities for such drug, 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. Even if marketing approval of a drug
candidate is granted, the approval may be subject to limitations on the indicated uses for which the drug may be marketed or to the conditions
of approval, including the requirement to implement a REMS. New cancer drugs frequently are indicated only for patient populations that
have not responded to an existing therapy or have relapsed. If any of our drug candidates receives marketing approval, the accompanying
label may limit the approved use of our drug in this way, which could limit sales of the drug.

 The
FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy
of the drug, including the adoption and implementation of REMS. The FDA and other agencies, including the Department of Justice, or the
DOJ, closely regulate and monitor the post-approval marketing and promotion of drugs to ensure they are marketed and distributed only
for the approved indications and in accordance with the provisions of the approved labeling. The FDA and DOJ impose stringent restrictions
on manufacturers' communications regarding off-label use, and if we do not market our drugs for their approved indications, we
may be subject to enforcement action for off-label marketing. Violations of the FDCA and other statutes, including the False Claims Act,
relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions alleging violations
of federal and state healthcare 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 drugs, manufacturers or manufacturing processes,
or failure to comply with regulatory requirements, may have various consequences, including:

 restrictions
 on such drugs, manufacturers or manufacturing processes;

 restrictions
 and warnings on the labeling or marketing of a drug;

 restrictions
 on drug distribution or use;

 requirements
 to conduct post-marketing studies or clinical trials;

 warning
 letters or untitled letters;

 withdrawal
 of the drugs from the market;

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

 recall
 of drugs;

 fines,
 restitution or disgorgement of profits or revenues;

 suspension
 or withdrawal of marketing approvals;

 damage
 to relationships with any potential collaborators;

 unfavorable
 press coverage and damage to our reputation;

 refusal
 to permit the import or export of our drugs;

 drug
 seizure;

 injunctions
 or the imposition of civil or criminal penalties; or

 litigation
 involving patients using our drugs.

 Non-compliance
with European Union requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of
drugs for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the European
Union's requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

 In
addition, manufacturers of approved drugs and those manufacturers' facilities are required to comply with extensive FDA requirements,
including ensuring that quality control and manufacturing procedures conform to cGMPs applicable to drug manufacturers or quality assurance
standards applicable to medical device manufacturers, which include requirements relating to quality control and quality assurance as
well as the corresponding maintenance of records and documentation and reporting requirements. We, any contract manufacturers we may
engage in the future, our future collaborators and their contract manufacturers will also be subject to other regulatory requirements,
including submissions of safety and other post-marketing information and reports, registration and listing requirements, requirements
regarding the distribution of samples to clinicians, recordkeeping, and costly post-marketing studies or clinical trials and surveillance
to monitor the safety or efficacy of the drug such as the requirement to implement a REMS.

 We
operate in a highly competitive and rapidly changing industry.

 Biotechnological
and pharmaceutical drug development is highly competitive and subject to rapid and significant technological advancements. Our success
is highly dependent upon our ability to in-license, acquire, develop and obtain regulatory approval for new and innovative drugs on a
cost-effective basis and to market them successfully. In doing so, we face and will continue to face intense competition from a variety
of businesses, including large, fully integrated, well-established pharmaceutical companies who already possess a large share of the
market, specialty pharmaceutical and biopharmaceutical companies, academic institutions, government agencies and other private and public
research institutions in the United States, the European Union and other jurisdictions.

 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, preclinical testing, conducting clinical trials, obtaining regulatory approvals
and marketing approved drugs than we do. 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. Mergers and acquisitions in the pharmaceutical and biotechnology industries could result in even
more resources being concentrated among a small number of our competitors.

 Competition
may further increase as a result of advances in the commercial applicability of technologies and greater availability of capital for
investment in these industries. Our competitors may succeed in developing, acquiring or licensing, on an exclusive basis, drugs that
are more effective or less costly than any drug candidate that we may develop.

 Established
pharmaceutical and biotechnology companies may invest heavily to accelerate discovery and development of novel compounds or to in-license
novel compounds that could make our drug candidates less competitive. In addition, any new drug that competes with an approved drug must
demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be
commercially successful. Accordingly, our competitors may succeed in obtaining patent protection, discovering, developing, receiving
FDA approval for or commercializing drugs before we do, which would have an adverse impact on our business and results of operations.

 The
availability of our competitors' drugs could limit the demand and the price we are able to charge for any drug candidate we commercialize,
if any. The inability to compete with existing or subsequently introduced drugs would harm our business, financial condition and results
of operations.

 If
we are unable to develop satisfactory sales and marketing capabilities, we may not succeed in commercializing LP-300, LP-184, LP-284
or any other drug candidate.

 We
have no experience in marketing and selling drug products. We have not entered into arrangements for the sale and marketing of LP-300,
LP-184, LP-284 or any other drug candidate. Typically, pharmaceutical companies would employ groups of sales representatives and associated
sales and marketing staff numbering in the hundreds to thousands of individuals to call on this large number of physicians and hospitals.
We may seek to collaborate with a third party to market our drugs or may seek to market and sell our drugs by ourselves. If we seek to
collaborate with a third party, we cannot be sure that a collaborative agreement can be reached on terms acceptable to us. If we seek
to market and sell our drugs directly, we will need to hire additional personnel skilled in marketing and sales. We cannot be sure that
we will be able to acquire, or establish third party relationships to provide, any or all of these marketing and sales capabilities.
The establishment of a direct sales force or a contract sales force or a combination direct and contract sales force to market our drugs
will be expensive and time-consuming and could delay any drug launch. Further, we can give no assurances that we may be able to maintain
a direct and/or contract sales force for any period of time or that our sales efforts will be sufficient to generate or to grow our revenues
or that our sales efforts will ever lead to profits.

 Even
if we obtain regulatory approvals to commercialize LP-300, LP-184, LP-284 or our other drug candidates, our drug candidates may not be
accepted by physicians or the medical community in general.

 There
can be no assurance that LP-300, LP-184, LP-284 and our other drug candidates or any other drug candidate successfully developed by us,
independently or with partners, will be accepted by physicians, hospitals and other health care facilities. LP-300, LP-184, LP-284 and
any future drug candidates we develop will compete with a number of drugs manufactured and marketed by major pharmaceutical and biotech
companies. The degree of market acceptance of any drugs we develop depends on a number of factors, including:

 our
 demonstration of the clinical efficacy and safety of LP-300, LP-184, LP-284 and our other drug candidates;

 timing
 of market approval and commercial launch of LP-300, LP-184, LP-284 and our other drug candidates;

 the
 clinical indication(s) for which LP-300, LP-184, LP-284 and our other drug candidates are approved;

 drug
 label and package insert requirements;

 advantages
 and disadvantages of our drug candidates compared to existing

 continued
 interest in and growth of the market for anticancer or anti-agitation drugs;

 strength
 of sales, marketing, and distribution support;

 drug
 pricing in absolute terms and relative to alternative treatments;

 future
 changes in health care laws, regulations, and medical policies; and

 availability
 of reimbursement codes and coverage in select jurisdictions, and future changes to reimbursement policies of government and third-party
 payors.

 Significant
uncertainty exists as to the coverage and reimbursement status of any drug candidate for which we obtain regulatory approval. In the
United States and markets in other countries, sales of any drugs for which we receive regulatory approval for commercial sale will depend
in part on the availability of reimbursement from third-party payors. Third-party payors include government health administrative authorities,
managed care providers, private health insurers and other organizations.

 Healthcare
reform measures could hinder or prevent our drug candidates' commercial success.

 The
U.S. government and other governments have shown significant interest in pursuing healthcare reform. Any government-adopted reform measures
could adversely impact the pricing of healthcare drugs and services in the United States or internationally and the amount of reimbursement
available from governmental agencies or other third-party payors. The continuing efforts of the U.S. and foreign governments, insurance
companies, managed care organizations and other payors of health care services to contain or reduce health care costs may adversely affect
our ability to set prices for our drugs which we believe are fair, and our ability to generate revenues and achieve and maintain profitability.

 In
the United States, some states have implemented, and other states are considering, pharmaceutical price controls or patient access constraints
under their Medicaid program. There have also been recent state legislative efforts that have generally focused on increasing transparency
around drug costs or limiting drug prices. In addition, the growth of large managed care organizations and prescription benefit managers,
as well as the prevalence of generic substitution, has hindered price increases for prescription drugs. Continued intense public scrutiny
of the price of drugs, together with government and payor dynamics, may limit the ability of producers and marketers to set or adjust
the price of products based on their value. Outside the United States, numerous major markets, including the EU, Japan and China, have
pervasive government involvement in funding healthcare, and, in that regard, fix the pricing and reimbursement of pharmaceutical products.
Consequently, our products generating will be subject to increasing government decision-making and budgetary actions. There can be no
assurance that new or proposed products will be considered cost-effective or that adequate third-party reimbursement will be available
to enable the producer or marketer of such product to maintain price levels sufficient to realize an appropriate return.

 New
laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to healthcare
availability, methods of delivery or payment for products and services, or sales, marketing or pricing, may limit our potential revenue,
and we may need to revise our research and development programs. The pricing and reimbursement environment may change in the future and
become more challenging due to several reasons, including policies advanced by the current executive administration in the United States,
new healthcare legislation or fiscal challenges faced by government health administration authorities. Specifically, in both the United
States and some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system
in ways that could affect our ability to sell our drugs profitably.

 For
example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or the PPACA
has substantially changed the way healthcare is financed by both government health plans and private insurers, and significantly impacts
the pharmaceutical industry. The PPACA contains a number of provisions that are expected to impact our business and operations in ways
that may negatively affect our potential revenues in the future. For example, the PPACA imposes a non-deductible excise tax on pharmaceutical
manufacturers or importers that sell branded prescription drugs to government programs which we believe will increase the cost of our
drugs. In addition, as part of the PPACA's provisions closing a funding gap that currently exists in the Medicare Part D prescription
drug program, we will be required to provide a discount on branded prescription drugs equal to 50% of the government-negotiated price,
for drugs provided to certain beneficiaries who fall within the donut hole. Similarly, PPACA increases the level of Medicaid rebates
payable by manufacturers of brand-name drugs from 15.1% to 23.1% and requires collection of rebates for drugs paid by Medicaid managed
care organizations. The PPACA also includes significant changes to the 340B drug discount program including expansion of the list of
eligible covered entities that may purchase drugs under the program. At the same time, the expansion in eligibility for health insurance
benefits created under PPACA is expected to increase the number of patients with insurance coverage who may receive our drugs. While
it is too early to predict all the specific effects the PPACA or any future healthcare reform legislation will have on our business,
they could have a material adverse effect on our business and financial condition.

 Congress
periodically adopts legislation like the PPACA and the Medicare Prescription Drug, Improvement and Modernization Act of 2003, that modifies
Medicare reimbursement and coverage policies pertaining to prescription drugs. Implementation of these laws is subject to ongoing revision
through regulatory and sub regulatory policies. Congress also may consider additional changes to Medicare policies, potentially including
Medicare prescription drug policies, as part of ongoing budget negotiations. While the scope of any such legislation is uncertain at
this time, there can be no assurances that future legislation or regulations will not decrease the coverage and price that we may receive
for our proposed drugs. Other third-party payors are increasingly challenging the prices charged for medical products and services. It
will be time consuming and expensive for us to go through the process of seeking coverage and reimbursement from Medicare and private
payors. Our proposed drugs may not be considered cost-effective, and coverage and reimbursement may not be available or sufficient to
allow us to sell our proposed drugs on a profitable basis. Further federal and state proposals and health care reforms are likely which
could limit the prices that can be charged for the drug candidates that we develop and may further limit our commercial opportunities.
Our results of operations could be materially adversely affected by proposed healthcare reforms, by the Medicare prescription drug coverage
legislation, by the possible effect of such current or future legislation on amounts that private insurers will pay and by other health
care reforms that may be enacted or adopted in the future.

 In
September 2007, the Food and Drug Administration Amendments Act of 2007 was enacted, giving the FDA enhanced post-marketing authority,
including the authority to require post-marketing studies and clinical trials, labeling changes based on new safety information, and
compliance with risk evaluations and mitigation strategies approved by the FDA. The FDA's exercise of this authority could result
in delays or increased costs during drug development, clinical trials and regulatory review, increased costs to assure compliance with
post-approval regulatory requirements, and potential restrictions on the sale and/or distribution of approved drugs.

 Our
relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse,
false claims, transparency, health information privacy and security, and other healthcare laws and regulations, which, in the event of
a violation, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and
diminished profits and future earnings.

 Healthcare
providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any drug candidates for
which we obtain marketing approval. Our future arrangements with healthcare providers, physicians and third-party payors may expose us
to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements
and relationships through which we market, sell and distribute any drugs for which we obtain marketing approval. In addition, we may
be subject to transparency laws and patient privacy regulation by U.S. federal and state governments and by governments in foreign jurisdictions
in which we conduct our business. Restrictions under applicable federal and state healthcare laws and regulations include the following:

 the
 federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving
 or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral
 of an individual for, or the purchase, order or recommendation or arranging of, any good or service, for which payment may be made
 under a federal healthcare program such as Medicare and Medicaid;

 the
 federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against
 individuals or entities for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for
 payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing
 or concealing an obligation to pay money to the federal government, with potential liability including mandatory treble damages and
 significant per-claim penalties;

 the
 federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing
 a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

 HIPAA,
 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations,
 also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission
 of individually identifiable health information;

 the
 federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs to report payments and other transfers
 of value to physicians and teaching hospitals; and

 analogous
 state and foreign laws and regulations, such as state anti-kickback and false claims laws and transparency statutes, may apply to
 sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors,
 including private insurers.

 Some
state laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the
relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to
payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Additionally, some state
and local laws require the registration of pharmaceutical sales representatives in the jurisdiction. State and foreign laws also govern
the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often
are not preempted by HIPAA, thus complicating compliance efforts.

 Efforts
to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve
substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current
or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations
are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant
civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of drugs from government funded healthcare programs,
such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers
or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal,
civil or administrative sanctions, including exclusions from participation in government funded healthcare programs.

 Currently
enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug
candidates and affect the prices we may obtain for any drugs that are approved in the United States or foreign jurisdictions.

 In
the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes
regarding the healthcare system that could prevent or delay marketing approval of our drug candidates, restrict or regulate post-approval
activities and affect our ability to profitably sell any drug candidates for which we obtain marketing approval. The pharmaceutical industry
has been a particular focus of these efforts and has been significantly affected by legislative initiatives. Current laws, as well as
other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward
pressure on the price that we receive for any FDA approved drug.

 In
the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers
and pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new
reimbursement methodology based on average sales prices for physician-administered drugs. In addition, this legislation provided authority
for limiting the number of drugs that will be covered in any therapeutic class. Cost reduction initiatives and other provisions of this
legislation could decrease the coverage and price that we receive for any approved drugs. 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 reimbursement
rates. Therefore, any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private
payors.

 In
March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Reconciliation Act of 2010, or collectively the ACA. Among the provisions of the ACA of potential importance to our business, including,
without limitation, our ability to commercialize and the prices we may obtain for any of our drug candidates that are approved for sale,
are the following:

 an
 annual, non-deductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents;

 an
 increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;

 expansion
 of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative
 powers and enhanced penalties for noncompliance;

 a
 new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and 70% starting January 1, 2019)
 point-of-sale discounts off negotiated prices;

 extension
 of manufacturers' Medicaid rebate liability;

 expansion
 of eligibility criteria for Medicaid programs;

 expansion
 of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

 new
 requirements to report certain financial arrangements with physicians and teaching hospitals;

 a
 new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and

 a
 new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness
 research, along with funding for such research.

 In
addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes include the Budget Control
Act of 2011, which, among other things, led to aggregate reductions to Medicare payments to providers of up to 2% per fiscal year that
started in 2013 and, due to subsequent legislative amendments to the statute, will stay in effect through 2027 unless additional congressional
action is taken, and the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several types
of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five
years. These new laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we
may obtain for any of our drug candidates for which we may obtain regulatory approval or the frequency with which any such drug candidate
is prescribed or used. Further, there have been several recent U.S. congressional inquiries and proposed state and federal legislation
designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient
programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

 We
expect that these healthcare reforms, as well as other healthcare reform measures that may be adopted in the future, may result in additional
reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward
pressure on the price that we receive for any approved drug and/or the level of reimbursement physicians receive for administering any
approved drug we might bring to market. Reductions in reimbursement levels may negatively impact the prices we receive or the frequency
with which our drugs are prescribed or administered. Any reduction in reimbursement from Medicare or other government programs may result
in a similar reduction in payments from private payors.

 The
costs of prescription pharmaceuticals have also been the subject of considerable discussion in the United States, and members of Congress
have stated that they will address such costs through new legislative and administrative measures. To date, there have been several recent
U.S. congressional inquiries and proposed and enacted state and federal legislation designed to, among other things, bring more transparency
to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare
and reform government program reimbursement methodologies for drug products. While any proposed measures will require authorization through
additional legislation to become effective, Congress has indicated that it will continue to seek new legislative and/or administrative
measures to control drug costs. At the state level, legislatures are increasingly passing legislation and implementing regulations designed
to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions
on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation
from other countries and bulk purchasing.

 Legislative
and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical
products. We cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations
will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. Increased scrutiny
by the U.S. Congress of the FDA's approval process may significantly delay or prevent marketing approval, as well as subject us
to more stringent product labeling and post-marketing testing and other requirements.

 Governments
outside of the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

 In
some countries, particularly the countries of the European Union and Canada, the pricing of prescription pharmaceuticals is subject to
governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt
of marketing approval for a drug. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical
trial that compares the cost-effectiveness of our drug candidate to other available therapies. In the European Union, a member state
may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability
of the company placing the medicinal product on the market. If reimbursement of our drugs is unavailable or limited in scope or amount,
or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially. Historically, products launched in
the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.

 If
we or any third-party manufacturers or contractors we engage now or in the future fail to comply with environmental, health and safety
laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business.

 We
and third-party manufacturers we engage now are, and any third-party manufacturers we may engage in the future will be, subject to numerous
environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage,
treatment and disposal of hazardous materials and wastes. Our operations, including work conducted through third-party manufacturers
or contractors, involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also
produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot
eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of
hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. Liability under
certain environmental laws governing the release and cleanup of hazardous materials is joint and several and could be imposed without
regard to fault. We also could incur significant costs associated with civil or criminal fines and penalties or become subject to injunctions
limiting or prohibiting our activities for failure to comply with such laws and regulations.

 Although
we maintain general liability insurance as well as workers' compensation insurance to cover us for costs and expenses we may incur
due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against
potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us
in connection with our, or our contractors, storage or disposal of biological, hazardous or radioactive materials.

 In
addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.
These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these
laws and regulations also may result in substantial fines, penalties or other sanctions.

 Further,
with respect to the operations of our current and any future third-party contract manufacturers or other contractors, it is possible
that if they fail to operate in compliance with applicable environmental, health and safety laws and regulations or properly dispose
of wastes associated with our drugs, we could be held liable for any resulting damages, suffer reputational harm or experience a disruption
in the manufacture and supply of our drug candidates or drugs. In addition, our supply chain may be adversely impacted if any of our
third-party contract manufacturers become subject to injunctions or other sanctions as a result of their non-compliance with environmental,
health and safety laws and regulations.

 We
may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our RADR
 platform.

 We
operate in businesses that require sophisticated computer systems and software for data collection, data processing, cloud-based platforms,
analytics, statistical projections and forecasting, mobile computing, social media analytics and other applications and technologies.
We seek, in part, to address our technology risks by increasing our reliance on the use of innovations by cross-industry technology leaders
and adapting these for our applicable needs and applications. Some of the technologies supporting our industry are changing rapidly and
we must continue to adapt to these changes in a timely and effective manner at an acceptable cost. We also must continue to obtain and
utilize data to in forms that are easy to use while simultaneously providing clear answers to complex questions. There can be no guarantee
that we will be able to develop, acquire or integrate new technologies, that these new technologies will meet our needs or achieve our
expected goals, or that we will be able to do so as quickly or cost-effectively as our competitors. Significant technological change
could render our RADR platform obsolete. Our continued success will depend on our ability to adapt to changing technologies,
manage and process ever-increasing amounts of data and information and improve the performance, features and reliability of our platform
and capabilities in response to changing internal and industry demands. We may experience difficulties that could delay or prevent the
successful design, development, testing, and introduction of advanced versions of our RADR platform, limiting our ability
to identify new drug candidates. New services, or enhancements to existing services using our RADR platform, may not
adequately meet our requirements. Any of these failures could have a material adverse effect on our operating results and financial condition.

 Risks
Related to Our Reliance on Third Parties

 We
rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully perform their
contractual legal and regulatory duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize
our drug candidates and our business could be substantially harmed.

 We
have relied upon and plan to continue to rely upon third-party medical institutions, clinical investigators, contract laboratories and
other third party CROs to monitor and manage data for our ongoing preclinical and clinical programs. We also rely on these parties for
execution of our preclinical studies and clinical trials, and control only certain aspects of their activities. Nevertheless, we are
responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific
standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities. We and our CROs are required to comply
with cGCPs, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European
Economic Area, or EEA, and comparable foreign regulatory authorities, for all of our drugs in clinical development.

 Regulatory
authorities enforce these cGCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any
of our CROs fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the
FDA, the EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing
applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that
any of our clinical trials comply with cGCP regulations. In addition, our clinical trials must be conducted with product produced under
current good manufacturing practices, or cGMP, regulations. Our failure to comply with these regulations may require us to repeat clinical
trials, which would delay the regulatory approval process.

 If
any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or
to do so on commercially reasonable terms. In addition, our CROs are not our employees, and except for remedies available to us under
our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our on-going clinical, nonclinical
and preclinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if
they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to
our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and
we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates. As a result, our results of operations
and the commercial prospects for our drug candidates would be harmed, our costs could increase and our ability to generate revenues could
be delayed.

 Many
of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for
whom they may also be conducting clinical trials or other drug development activities that could harm our competitive position. If the
third parties conducting our GLP preclinical studies or our clinical trials do not perform their contractual duties or obligations, experience
work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy
of the clinical data they obtain is compromised due to their failure to adhere to our clinical trial protocols or to GCPs, or for any
other reason, we may need to enter into new arrangements with alternative third parties. Switching or adding additional CROs involves
additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work.
As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully
manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future
or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

 We
are substantially dependent on third parties for the manufacture of our clinical supplies of our drug candidates, and we intend to rely
on third parties to produce commercial supplies of any approved drug candidate. Therefore, our development of our drugs could be stopped
or delayed, and our commercialization of any future drug could be stopped or delayed or made less profitable if third party manufacturers
fail to obtain approval of the FDA or comparable regulatory authorities or fail to provide us with drug products in sufficient quantities
or at acceptable prices.

 The
manufacture of pharmaceutical products is complex and requires significant expertise, capital investment, process controls and know-how.
Common difficulties in pharmaceutical manufacturing may include: sourcing and producing raw materials, transferring technology from chemistry
and development activities to production activities, validating initial production designs, scaling manufacturing techniques, improving
costs and yields, establishing and maintaining quality controls and stability requirements, eliminating contaminations and operator errors,
and maintaining compliance with regulatory requirements. We do not currently have nor do we plan to acquire the infrastructure or capability
internally in accordance with cGMP prescribed by the FDA or to produce an adequate supply of compounds to meet future requirements for
clinical trials and commercialization of our drugs. Drug manufacturing facilities are subject to inspection before the FDA will issue
an approval to market a new drug product, and all of the manufacturers that we intend to use must adhere to the cGMP regulations prescribed
by the FDA.

 We
expect therefore to rely on third-party manufacturers for clinical supplies of our drug candidates that we may develop. These third-party
manufacturers will be required to comply with current good manufacturing practices, or GMPs, and other applicable laws and regulations.
We will have no control over the ability of these third parties to comply with these requirements, or to maintain adequate quality control,
quality assurance and qualified personnel. If the FDA or any other applicable regulatory authorities do not approve the facilities of
these third parties for the manufacture of our other drug candidates or any drugs that we may successfully develop, or if it withdraws
any such approval, or if our suppliers or contract manufacturers decide they no longer want to supply or manufacture for us, we may need
to find alternative manufacturing facilities, in which case we might not be able to identify manufacturers for clinical or commercial
supply on acceptable terms, or at all. Any of these factors would significantly impact our ability to develop, obtain regulatory approval
for or market our drug candidates and adversely affect our business.

 We
and/or our third-party manufacturers may be adversely affected by developments outside of our control, and these developments may delay
or prevent further manufacturing of our drugs. Adverse developments may include labor disputes, resource constraints, shipment delays,
inventory shortages, lot failures, impacts related to epidemics or infectious disease outbreaks, geopolitical turmoil in Ukraine, Gaza
and elsewhere, unexpected sources of contamination, lawsuits related to our manufacturing techniques, equipment used during manufacturing,
or composition of matter, unstable political environments, acts of terrorism, war, natural disasters, and other natural and man-made
disasters. If we or our third-party manufacturers were to encounter any of the above difficulties, or otherwise fail to comply with contractual
obligations, our ability to provide any drug for clinical trial or commercial purposes would be jeopardized. This may increase the costs
associated with completing our clinical trials and commercial production. Further, production disruptions may cause us to terminate ongoing
clinical trials and/or commence new clinical trials at additional expense. We may also have to take inventory write-offs and incur other
charges and expenses for drugs that fail to meet specifications or pass safety inspections. If production difficulties cannot be solved
with acceptable costs, expenses, and timeframes, we may be forced to abandon our clinical development and commercialization plans, which
could have a material adverse effect on our business, prospects, financial condition, and the value of our securities.

 We,
or third-party manufacturers on whom we rely, may be unable to successfully scale-up manufacturing of our drug candidates in sufficient
quality and quantity, which would delay or prevent us from developing our drug candidates and commercializing approved drugs, if any.

 In
order to conduct clinical trials of our drug candidates and commercialize any approved drug candidates, we, or our manufacturers, will
need to manufacture them in large quantities. We, or our manufacturers, may be unable to successfully increase the manufacturing capacity
for any of our drug candidates in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up
activities. If we, or any of our manufacturers, are unable to successfully scale up the manufacture of our drug candidates in sufficient
quality and quantity, the development, testing, and clinical trials of that drug candidate may be delayed or infeasible, and regulatory
approval or commercial launch of any resulting drug may be delayed or not obtained, which could significantly harm our business. If we
are unable to obtain or maintain third-party manufacturing for commercial supply of our drug candidates, or to do so on commercially
reasonable terms, we may not be able to develop and commercialize our drug candidates successfully.

 Our
failure to find third party collaborators to assist or share in the costs of drug development could materially harm our business, financial
condition and results of operations.

 Our
strategy for the development and commercialization of our proprietary drug candidates may include the formation of collaborative arrangements
with third parties. Existing and future collaborators have significant discretion in determining the efforts and resources they apply
and may not perform their obligations as expected. Potential third-party collaborators include biopharmaceutical, pharmaceutical and
biotechnology companies, academic institutions and other entities. Third-party collaborators may assist us in:

 funding
 research, preclinical development, clinical trials and manufacturing;

 seeking
 and obtaining regulatory approvals; and

 successfully
 commercializing any future drug candidates.

 If
we are not able to establish further collaboration agreements, we may be required to undertake drug development and commercialization
at our own expense. Such an undertaking may limit the number of drug candidates that we will be able to develop, significantly increase
our capital requirements and place additional strain on our internal resources. Our failure to enter into additional collaborations could
materially harm our business, financial condition and results of operations.

 In
addition, our dependence on licensing, collaboration and other agreements with third parties may subject us to a number of risks. These
agreements may not be on terms that prove favorable to us and may require us to relinquish certain rights in our drug candidates. To
the extent we agree to work exclusively with one collaborator in a given area, our opportunities to collaborate with other entities could
be curtailed. Lengthy negotiations with potential new collaborators may lead to delays in the research, development or commercialization
of drug candidates. The decision by our collaborators to pursue alternative technologies or the failure of our collaborators to develop
or commercialize successfully any drug candidate to which they have obtained rights from us could materially harm our business, financial
condition and results of operations.

 Cash
balances held at banking institutions are in excess of FDIC coverage.

 We
maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured
limits. Interest bearing and non-interest bearing accounts we hold at banking institutions are guaranteed by the Federal Deposit Insurance
Corporation ("FDIC") up to $250,000. Substantially all of our cash balances held at banking institutions are in excess of
FDIC coverage. We consider this to be a normal business risk.

 Risks
Related to Our Business and Industry

 We
will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties
in managing growth.

 As
of the date of this report, we employ a total of 24 employees. Our current internal departments include clinical development, preclinical
research and development, RADR platform and information technology team, and finance and administration. We intend to
expand our management team to include an operation ramp up of additional scientific development and technical staff required to achieve
our business objectives. We also intend to expand our managerial, operational, technical and scientific, financial and other resources
in order to manage our operations and clinical trials, continue our research and development activities, and advance our drug candidates
towards commercializations. Our management and scientific personnel, systems and facilities currently in place may not be adequate to
support our future growth.

 Our
need to effectively manage our operations, growth and various projects requires that we:

 manage
 our clinical trials effectively, including our existing and planned clinical trials;

 manage
 our internal development efforts effectively while carrying out our contractual obligations to licensors, contractors and other third
 parties;

 to improve our operational, financial and management controls and reporting systems and procedures; and

 attract
 and retain sufficient numbers of talented employees.

 We
are utilizing and expect in the future to utilize the services of vendors and research partners or collaborators to perform tasks including
preclinical studies and clinical trial management, statistics and analysis, regulatory affairs, medical advisory, market research, formulation
development, chemistry, manufacturing and control activities, other drug development functions, legal, auditing, financial advisory,
and investor relations. Our growth strategy may also entail expanding our group of contractors or consultants to implement these and
other tasks going forward. Because we rely on numerous consultants to outsource many key functions of our business, we will need to be
able to effectively manage these consultants to ensure that they successfully carry out their contractual obligations and meet expected
deadlines. However, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided
by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain
regulatory approval for our drug candidate or otherwise advance our business. There can be no assurance that we will be able to manage
our existing consultants or find other competent outside contractors and consultants on economically reasonable terms, or at all. If
we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors,
we may be unable to successfully implement the tasks necessary to further develop and commercialize our drug candidates and, accordingly,
may not achieve our research, development and commercialization goals.

 We
depend on our senior management team, and the loss of one or more of our executive officers or key employees or an inability to attract
and retain highly skilled employees could adversely affect our business.

 Our
success depends largely upon the continued services of Panna Sharma, our Chief Executive Officer, President and Director. We do not maintain
"key person" insurance for Mr. Sharma or any of our other key employees. We also rely on employees in the areas of research
and development, artificial intelligence and machine learning services and general and administrative functions, some of which are in
the US on H-1B work visas. From time to time, there may be changes in our executive management and employees resulting from the hiring
or departure of executives or other key employees or the expiration or termination of H-1B work visas, which could disrupt our business.
The replacement of one or more of our executive officers or other key employees would likely involve significant time and costs and may
significantly delay or prevent the achievement of our business objectives.

 To
continue to execute our growth strategy, we also must attract and retain highly skilled personnel. We might not be successful in maintaining
our unique culture and continuing to attract and retain qualified personnel. We have from time to time in the past experienced, and we
expect to continue to experience in the future, difficulty in hiring and retaining highly skilled personnel with appropriate qualifications.
The pool of qualified personnel with experience in artificial intelligence, machine learning, and genomics, or experience working with
the pharma market is limited overall. In addition, many of the companies with which we compete for experienced personnel have greater
resources than we have.

 In
addition, in making employment decisions, particularly in the biotechnology and pharmaceutical industries, job candidates often consider
the value of the stock options or other equity instruments they are to receive in connection with their employment. Volatility in the
price of our stock might, therefore, adversely affect our ability to attract or retain highly skilled personnel. Furthermore, the requirement
to expense stock options and other equity instruments might discourage us from granting the size or type of stock option or equity awards
that job candidates require to join our company. If we fail to attract new personnel or fail to retain and motivate our current personnel,
our business and future growth prospects could be severely harmed.

 Our
employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and
insider trading.

 We
are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with
any regulations applicable to us, to provide accurate information to regulatory authorities, to comply with manufacturing standards we
have established, to comply with federal and state healthcare fraud and abuse laws and regulations, or to report financial information
or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare
industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive
practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission,
customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained
in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have adopted a Code
of Business Conduct, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and
prevent this activity may not be effective in controlling unknown or unmanaged risk. If our employees engage in any such misconduct,
we could face criminal penalties, fines, revocation of regulatory approvals and harm to our reputation, any of which could form a material
adverse effect on our business.

 Business
interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses.

 Our
operations, and those of our directors, advisors, contractors, consultants, CROs, and collaborators, could be adversely affected by earthquakes,
floods, hurricanes, typhoons, extreme weather conditions, fires, water shortages, power failures, business systems failures, medical
epidemics and other natural and man-made disaster or business interruptions. Our phones, electronic devices and computer systems and
those of our directors, advisors, contractors, consultants, CROs, and collaborators are vulnerable to damages, theft and accidental loss,
negligence, unauthorized access, terrorism, war, electronic and telecommunications failures, and other natural and man-made disasters.
Operating as a company where many employees have and are working remotely, our employees conduct business outside of our headquarters
and leased or owned facilities. These locations may be subject to additional security and other risk factors due to the limited control
of our employees. If such an event as described above were to occur in the future, it may cause interruptions in our operations, delay
research and development programs, clinical trials, regulatory activities, manufacturing and quality assurance activities, sales and
marketing activities, hiring, training of employees and persons within associated third parties, and other business activities. For example,
the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and
significantly increase our costs to recover or reproduce the data.

 Likewise,
we rely and will rely on third parties to manufacture LP-300, LP-184, LP-284 and other drug candidates and to conduct clinical trials,
and similar events as those described in the prior paragraph relating to their business systems, equipment and facilities could also
have a material adverse effect on our business. 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 further development and commercialization of our drug candidates could be delayed or altogether terminated.

 Disruptions
to our information technology systems, including future cyber-attacks and security breaches, and the costs of maintaining secure and
effective information technology systems could negatively affect our business and results of operations.

 The
efficient operation of our businesses is highly dependent on computer hardware and software systems, including our customized information
technology systems that form our RADR platform. Information systems are vulnerable to security breaches by computer hackers
and cyber terrorists. We rely on industry accepted security measures and technology to securely maintain confidential and proprietary
information maintained on our information systems, and continue to invest in maintaining and upgrading these systems and applications
to ensure risk is controlled. Regardless of our efforts to maintain and upgrade our cyber security systems, there can be no assurance
that we will not suffer an intrusion, that unauthorized parties will not gain access to confidential or personal information, or that
any such incident will be discovered promptly. The techniques used by criminals to obtain unauthorized access to sensitive data change
frequently and often are not recognized until launched against a target, and we may be unable to anticipate these techniques or implement
adequate preventative measures. The failure to promptly detect, determine the extent of and appropriately respond to a significant data
security breach could have a material adverse impact on our business, financial condition and results of operations. In addition, the
unavailability of the information systems or failure of these systems to perform as anticipated for any reason, including a major disaster
or business interruption resulting in an inability to access data stored in these systems or sustain the data center systems necessary
to support functions to meet our needs, and any inability to respond to, or recover from, such an event, could disrupt our business and
could result in decreased performance and increased overhead costs, causing our business and results of operations to suffer.

our operations involve the receipt and storage of sensitive data, including personal information about our employees and proprietary
business information of ours and our vendors. We may also share information with vendors that assist us in conducting our business, as
required by law, with the permission of the individual or as permitted under applicable privacy policies.

 Despite
the utilization of information security measures, we cannot be certain that all of our IT systems or the IT systems of our vendors are
or will be able to prevent, contain or detect any future cyber-attacks or security breaches from known malware, malware that may be developed
in the future or otherwise. Cyber-attacks are rapidly evolving and becoming increasingly sophisticated and difficult to detect, and therefore,
we may be unable to anticipate these attacks or implement adequate preventive measures. Additionally, unauthorized parties may attempt
to gain access to our or a vendor's systems or facilities through fraud, trickery or other forms of deception involving our employees
or vendors. To the extent that any attack or breach results in the loss, damage or misappropriation of information, we may be adversely
affected by claims from persons participating in our clinical trials, stockholders and others and by costly inquiries or enforcement
actions on the part of regulatory authorities. Our operations could also be significantly disrupted by these claims, as well as by the
need to spend significant time and expense to upgrade, fix or replace our systems. We could also lose credibility with persons participating
in our clinical trials and suffer damage to our reputation and future sales, if any. In addition, the cost of complying with stricter
privacy and information security laws and standards and developing, maintaining and upgrading technology systems to address future advances
in technology, could be significant and we could experience problems and interruptions associated with the implementation of new or upgraded
systems and technology or with maintenance or adequate support of existing systems.

 Unfavorable
geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations.

 Our
business could be adversely affected by conditions in the U.S. and global economies, the United States and global financial markets and
adverse geopolitical and macroeconomic developments, including rising inflation rates, the continuing impact of the COVID-19 pandemic
or other pandemics, geopolitical risk, including in Taiwan where we are pursuing clinical testing of LP-300, the Ukrainian/Russian and
Israeli/Palestinian conflicts and related sanctions, bank failures, and economic uncertainties related to these conditions.

 For
example, inflation rates, particularly in the United States, have increased recently to levels not seen in years, and increased inflation
may result in increases in our operating costs (including our labor costs), reduced liquidity and limits on our ability to access credit
or otherwise raise capital on acceptable terms, if at all. In response to rising inflation, the U.S. Federal Reserve has raised, and
may again raise, interest rates, which, coupled with reduced government spending and volatility in financial markets, may have the effect
of further increasing economic uncertainty and heightening these risks.

 While
the COVID-19 pandemic has abated, many of the consequences of the COVID-19 pandemic continue to cause disruption and increased costs
for businesses. In the case of clinical stage biopharmaceutical companies, we believe there continue to be, among other things, supply
chain disruptions that are causing delays in the delivery of drug candidates and comparator products and healthcare staffing shortages
that are causing delays in the establishment of test sites and the conduct of clinical trials.

financial markets around the world experienced volatility following the invasion of Ukraine by Russia in February 2022 and the eruption
of the Israeli/Palestinian conflict in October 2023, including as a result of economic sanctions and export controls against Russia and
countermeasures taken by Russia. The full economic and social impact of these sanctions and countermeasures, in addition to the ongoing
military conflicts in Ukraine and Gaza, which could conceivably expand, remains uncertain; however, both the conflicts and related sanctions
have resulted and could continue to result in disruptions to trade, commerce, pricing stability, credit availability, and/or supply chain
continuity, in both Europe and globally, and has introduced significant uncertainty into global markets. While we do not currently operate
in Russia, Ukraine or the Middle East, as the adverse effects of these conflicts continue to develop our business and results of operations
may be adversely affected.

 Our
failure to successfully acquire, develop and market additional drug candidates could impair our ability to grow.

 As
part of our growth strategy, we may evaluate, acquire, license, develop and/or market additional drug candidates and technologies. Our
internal research capabilities are limited and we may be dependent upon pharmaceutical and biopharmaceutical companies, academic scientists
and other researchers to sell or license drug candidates or technologies to us. The success of this strategy depends partly upon our
ability to identify, select and acquire promising pharmaceutical drug candidates and technologies. The process of proposing, negotiating
and implementing a license or acquisition of a drug candidate is lengthy and complex. Other companies, including some with substantially
greater financial, marketing and sales resources, may compete with us for the license or acquisition of drug candidates and technologies.
We have limited resources to identify and execute the acquisition or in-licensing of potential drug candidates and technologies and to
integrate them into our current infrastructure. Moreover, we may devote resources to potential acquisitions or in-licensing opportunities
that are never completed, or we may fail to realize the anticipated benefits of such efforts. Furthermore, we may not be able to acquire
the rights to additional drug candidates on terms that we find acceptable, or at all.

 In
addition, future acquisitions of intellectual property rights may entail numerous operational and financial risks, including:

 exposure
 to unknown liabilities;

 disruption
 of our business and diversion of our management's and technical personnel's time and attention to develop acquired drug
 candidates or technologies;

 incurrence
 of substantial debt or dilutive issuances of securities to pay for acquisition costs;

 higher
 than expected acquisition costs; and

 increased
 amortization expenses.

 Any
drug candidate that we acquire may require additional development efforts prior to commercial sale or out-licensing, including extensive
clinical testing and approval by the FDA and applicable foreign regulatory authorities. All drug candidates are prone to risks of failure
typical of pharmaceutical drug development, including the possibility that a drug candidate will not be shown to be sufficiently safe
and effective for approval by regulatory authorities. In addition, we cannot provide assurance that any drugs that we may develop or
approved drugs that we may acquire will be manufactured profitably or achieve market acceptance.

 We
have obtained statistical data, market data and other industry data and forecasts used throughout this report from market research, publicly
available information and industry publications which we believe are reliable but have not been verified by any third party.

 This
report contains estimates, projections and other information concerning our industry, our business and the markets for our drug candidates,
including data regarding the estimated size of such markets and the incidence of certain medical conditions. We obtained the industry,
market and similar data set forth in this report from our internal estimates and research and from academic and industry research, publications,
surveys and studies conducted by third parties, including governmental agencies. In some cases, we do not expressly refer to the sources
from which this data is derived. Information that is based on estimates, forecasts, projections, market research or similar methodologies
is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are
assumed in this information. While we believe our internal research is reliable, such research has not been verified by any third party.

 Risks
Related to Our Intellectual Property

 If
we do not obtain patent term extension for any drug candidates we may develop, our business may be materially harmed.

 In
the United States, depending upon the timing, duration, and specifics of any FDA marketing approval of a drug candidate, the patent term
of a patent that covers an FDA-approved drug may be eligible for limited patent term extension, which permits patent term restoration
as compensation for the patent term lost during the FDA regulatory review process. The Drug Price Competition and Patent Term Restoration
Act of 1984, also known as the Hatch-Waxman Act, permits a patent term extension of up to five years beyond the expiration of the patent.
The length of the patent term extension is related to the length of time the drug is under regulatory review. Patent term extension cannot
extend the remaining term of a patent beyond a total of 14 years from the date of drug approval, and only one patent applicable to an
approved drug may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing
it may be extended. Similar provisions are available in Europe and other non-United States jurisdictions to extend the term of a patent
that covers an approved drug. While, in the future, if and when our drug candidates receive FDA approval, we expect to apply for patent
term extensions on patents directed to those drug candidates, there is no guarantee that the applicable authorities will agree with our
assessment of whether such extensions should be granted, and even if granted, the length of such extensions. We may not be granted an
extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to
apply within applicable deadlines, failing to apply prior to expiration of the relevant patents, or otherwise failing to satisfy applicable
requirements. If we are unable to obtain any patent term extension or the term of any such extension is less than we request, our competitors
may obtain approval of competing drugs following the expiration of our patent rights, and our business, financial condition, results
of operations, and prospects could be materially harmed.

 Changes
to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability
to protect our drugs.

 Changes
in either the patent laws or interpretation of patent laws in the United States, including patent reform legislation such as the Leahy-Smith
America Invents Act, or the Leahy-Smith Act, could increase the uncertainties and costs surrounding the prosecution of our owned and
in-licensed patent applications and the maintenance, enforcement or defense of our owned and in-licensed issued patents. The Leahy-Smith
Act includes a number of significant changes to United States patent law. These changes include provisions that affect the way patent
applications are prosecuted, redefine prior art, provide more efficient and cost-effective avenues for competitors to challenge the validity
of patents, and enable third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack
the validity of a patent at USPTO-administered post-grant proceedings, including post-grant review, inter parties review, and derivation
proceedings. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent
the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled
to the patent.

 After
March 2013, under the Leahy-Smith Act, the United States transitioned to a first-to-file system in which, assuming that the other statutory
requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention
regardless of whether a third party was the first to invent the claimed invention. As such, 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, financial condition, results of operations, and prospects.

 In
addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly
uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened
the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and
enforceability of patents once obtained. Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws
and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our patent rights and
our ability to protect, defend and enforce our patent rights in the future.

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

 Competitors
and other third parties may infringe, misappropriate or otherwise violate our or our licensor's issued patents or other intellectual
property. As a result, we or our licensors may need to file infringement, misappropriation or other intellectual property related claims,
which can be expensive and time-consuming. Any claims we assert against perceived infringers could provoke such parties to assert counterclaims
against us alleging that we infringe, misappropriate or otherwise violate their intellectual property. In addition, in a patent infringement
proceeding, such parties could counterclaim that the patents we or our licensors have asserted are invalid or unenforceable. In patent
litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity
challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement.
Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant
information from the USPTO, or made a misleading statement, during prosecution. Third parties may institute such claims before administrative
bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review,
inter parties review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition
proceedings).

 An
adverse result in any such proceeding could put one or more of our owned or in-licensed patents at risk of being invalidated or interpreted
narrowly, and could put any of our owned or in-licensed patent applications at risk of not yielding an issued patent. A court may also
refuse to stop the third party from using the technology at issue in a proceeding on the grounds that our owned or in-licensed patents
do not cover such technology. Furthermore, because of the substantial amount of discovery required in connection with intellectual property
litigation, there is a risk that some of our confidential information or trade secrets could be compromised by disclosure during this
type of litigation. Any of the foregoing could allow such third parties to develop and commercialize competing technologies and products
and have a material adverse impact on our business, financial condition, results of operations, and prospects.

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

 Our
commercial success depends upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our drug
candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property
and proprietary rights of third parties. There is considerable patent and other intellectual property litigation in the pharmaceutical
and biotechnology industries. We may become party to, or threatened with, adversarial proceedings or litigation regarding intellectual
property rights with respect to our technology and drug candidates, including interference proceedings, post grant review, inter parties
review, and derivation proceedings before the USPTO and similar proceedings in foreign jurisdictions such as oppositions before the European
Patent Office.

 The
legal threshold for initiating litigation or contested proceedings is low, so that even lawsuits or proceedings with a low probability
of success might be initiated and require significant resources to defend. Litigation and contested proceedings can also be expensive
and time-consuming, and our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting
these legal actions than we can. The risks of being involved in such litigation and proceedings may increase if and as our drug candidates
near commercialization and as we gain the greater visibility associated with being a public company. Third parties may assert infringement
claims against us based on existing patents or patents that may be granted in the future, regardless of merit. We may not be aware of
all such intellectual property rights potentially relating to our technology and drug candidates and their uses. Thus, we do not know
with certainty that our technology and drug candidates, or our development and commercialization thereof, do not and will not infringe,
misappropriate or otherwise violate any third party's intellectual property.

 Even
if we believe that third party intellectual property claims are without merit, there is no assurance that a court would find in our favor
on questions of misappropriation, infringement, validity, enforceability, or priority. A court of competent jurisdiction could hold these
third-party patents are valid, enforceable, and infringed, which could materially and adversely affect our ability to commercialize any
technology or drug candidate covered by the asserted third-party patents. In order to successfully challenge the validity of any such
U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present
clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction
would invalidate the claims of any such U.S. patent.

 If
we are found to infringe, misappropriate or otherwise violate a third party's intellectual property rights, we could be required
to obtain a license from such third party to continue developing, manufacturing and marketing our technology and drug candidates. 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 and other third parties access to the same technologies licensed to us and
could require us to make substantial licensing and royalty payments. We could be forced, including by court order, to cease developing,
manufacturing and commercializing the infringing technology or drug. In addition, we could be found liable for significant monetary damages,
including treble damages and attorneys' fees, if we are found to have willfully infringed a patent or other intellectual property
right and could be forced to indemnify our collaborators or others. A finding of infringement could prevent us from commercializing our
drug candidates or force us to cease some of our business operations, which could materially harm our business. In addition, we may be
forced to redesign, modify or reposition our drug candidates, seek new regulatory approvals and indemnify third parties pursuant to contractual
agreements. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material
adverse effect on our business, financial condition, results of operations, and prospects.

 Intellectual
property litigation or other legal proceedings relating to intellectual property 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 and may also have an advantage in such proceedings due to their more mature and developed intellectual
property portfolios. Uncertainties resulting from the initiation and continuation of intellectual property litigation or other proceedings
could compromise our ability to compete in the marketplace.

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

 Periodic
maintenance, renewal and annuity fees and various other government fees on any issued patent and pending patent application must be paid
to the USPTO and foreign patent agencies in several stages or annually over the lifetime of our owned and in-licensed patents and patent
applications. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary,
fee payment and other similar provisions during the patent application process. In certain circumstances, we rely on our licensing partners
to pay these fees to, or comply with the procedural and documentary rules of, the relevant patent agency. With respect to our patents,
we rely on an annuity service to remind us of the due dates and to make payment after we instruct them to do so. While an inadvertent
lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations
in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss
of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent
application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly
legalize and submit formal documents. In such an event, potential competitors might be able to enter the market with similar or identical
products or technology. If we or our licensors fail to maintain the patents and patent applications directed to our drug candidates,
it would have a material adverse effect on our business, financial condition, results of operations, and prospects.

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

 We
are party to license and funding agreements that impose, and we may enter into additional licensing and funding arrangements with third
parties that may impose, diligence, development and commercialization timelines, milestone payment, royalty, insurance and other obligations
on us. Under our existing licensing and funding agreements, we are obligated to pay certain specified milestone payments and royalties
on net drug sales of drug candidates or related technologies to the extent they are covered by the agreements. If we fail to comply with
such obligations under current or future license and funding agreements, our counterparties may have the right to terminate these agreements
or require us to grant them certain rights. Such an occurrence could materially adversely affect the value of any drug candidate being
developed under any such agreement. For example, under our agreement with AF Chemicals, LLC ("AF Chemicals"), we are required
to use commercially reasonable efforts to research, develop and commercialize LP-184. If we fail to meet the foregoing obligation, then,
under certain circumstances, AF Chemicals may terminate the AF Agreement and may exercise the exclusive, sub-licensable and worldwide
license we granted AF Chemicals in and to certain of our intellectual property to develop and commercialize LP-184. 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, which would have a material adverse effect on our business, financial condition, results of operations, and prospects.

these and other license agreements may not provide exclusive rights to use the licensed intellectual property and technology in all relevant
fields of use and in all territories in which we may wish to develop or commercialize our technology and drugs in the future. As a result,
we may not be able to prevent competitors from developing and commercializing competitive products and technology in fields of use and
territories not included in such agreements. In addition, we may not have the right to control the preparation, filing, prosecution,
maintenance, enforcement, and defense of patents and patent applications directed to the technology that we license from third parties.
Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, and defended
in a manner consistent with the best interests of our business. If our licensors fail to prosecute, maintain, enforce, and defend such
patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right
to develop and commercialize any of our drugs that are the subject of such licensed rights could be adversely affected.

 We
may need to obtain additional licenses from others to advance our research or allow commercialization of our drug candidates. It is possible
that we may be unable to obtain additional licenses at a reasonable cost or on reasonable terms, if at all, or such licenses may be non-exclusive.
The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies
may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. These
established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development
and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license
rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make
an appropriate return on our investment or at all.

 If
we are unable to obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights
we have, we may be required to expend significant time and resources to redesign our technology, drug candidates, or the methods for
manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.
If we are unable to do so, we may be unable to develop or commercialize the affected technology and drug candidates, which could harm
our business, financial condition, results of operations, and prospects significantly.

 Disputes
may arise regarding intellectual property subject to a licensing agreement, including:

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

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

 the
 sublicensing of patent and other rights under our collaborative development relationships;

 our
 diligence obligations under the license agreement and what activities satisfy those diligence obligations;

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

 the
 priority of invention of patented technology.

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

 Our
licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not
the sole and exclusive owners of the patents and patent applications we in-licensed. If other third parties have ownership rights to
our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products
and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations,
and prospects.

 In
spite of our best efforts, our licensors might conclude that we have materially breached our license agreements and might therefore terminate
the license agreements, thereby removing our ability to develop and commercialize drug candidates and technology covered by these license
agreements. If these in-licenses are terminated, or if the underlying intellectual property fails to provide the intended exclusivity,
competitors would have the freedom to seek regulatory approval of, and to market, products and technologies identical to ours. This could
have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

 We
may not be able to protect our intellectual property and proprietary rights throughout the world.

 Filing,
prosecuting, and defending patents on drug candidates in all countries throughout the world would be prohibitively expensive, and the
laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Consequently, we may not be
able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing
products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions
where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to
territories where we have patent protection or licenses but enforcement is not as strong as that in the United States. These products
may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them
from competing.

 Many
companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The
legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets,
and other intellectual property protection, particularly those relating to pharmaceutical products, which could make it difficult for
us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary
rights generally. Proceedings to enforce our intellectual property and proprietary rights in foreign jurisdictions could result in substantial
costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or
interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims against
us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.
Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant
commercial advantage from the intellectual property that we develop or license.

 Many
countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition,
many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent
owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors are forced to
grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and
our business, financial condition, results of operations, and prospects may be adversely affected.

 We
may be subject to claims by third parties asserting that our employees, consultants, contractors or advisors have wrongfully used or
disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their intellectual property,
or claiming ownership of what we regard as our own intellectual property.

 Many
of our employees, consultants, contractors and advisors were previously employed, or may currently be employed, at universities or other
pharmaceutical or biotechnology companies, including our competitors or potential competitors. Although we try to ensure that our employees,
contractors and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims
that these individuals or we have used or disclosed intellectual property, including trade secrets or other proprietary information,
of any such individual's current or former employer. Litigation may be necessary to defend against these claims.

 In
addition, while it is our policy to require our employees, consultants, contractors and advisors who may be involved in the development
of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an
agreement with each party who in fact develops intellectual property that we regard as our own. Our intellectual property assignment
agreements with them may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend
claims they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a
material adverse effect on our business, financial conditions, results of operations, and prospects.

 If
we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property
rights or personnel, which could have a material adverse effect on our competitive business position and prospects. Such intellectual
property rights could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize
our technology or products, which license may not be available on commercially reasonable terms, or at all, or such license may be non-exclusive.
Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction
to our management and employees.

 In
addition to seeking patents for some of our technology and drug candidates, we also rely on trade secrets and confidentiality agreements
relating to the development of our RADR platform to protect our unpatented know-how, technology and other proprietary
information, in order to maintain our competitive position. We seek to protect our trade secrets and other proprietary technology, in
part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate
collaborators, outside scientific collaborators, contract research organizations, contract manufacturers, consultants, advisors and other
third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. We
cannot guarantee that we have entered into such agreements with each party that may have or has had access to our trade secrets or proprietary
technology. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including
our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Detecting the disclosure or misappropriation
of a trade secret and enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and
time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside of the United States are less willing or
unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor
or other third party, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information
to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party,
our competitive position would be materially and adversely harmed.

 Intellectual
property rights do not necessarily address all potential threats.

 The
degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations
and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

 our
 RADR platform is not protected by any issued patents, and we may not be able to obtain, develop, acquire or in-license
 any patentable technologies or other intellectual property related to such platform;

 we,
 or our license partners or current or future collaborators, might not have been the first to make the inventions covered by the issued
 patent or pending patent applications that we license or may own in the future;

 we,
 or our license partners or current or future collaborators, might not have been the first to file patent applications covering certain
 of our or their inventions;

 others
 may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or
 in-licensed intellectual property rights;

 it
 is possible that our owned and in-licensed pending patent applications or those we may own or in-license in the future will not lead
 to issued patents;

 issued
 patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

 our
 competitors might conduct research and development activities in countries where we do not have patent rights and then use the information
 learned from such activities to develop competitive products for sale in our major commercial markets;

 we
 may not develop additional proprietary technologies that are patentable;

 the
 patents of others may harm our business; and

 we
 may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a
 patent covering such intellectual property.

 Should
any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and
prospects.

 Risks
Related to Owning our Common Stock

 Our
stock price has been volatile and thinly traded which may impair your ability to sell your shares.

 Our
common stock has traded on the Nasdaq Capital Market since June 11, 2020. From June 12, 2020 through March 17, 2025, our common stock
has frequently been thinly traded, with an average daily trading volume of approximately 75,989 shares and prices ranging from a low
of $2.38 to a high of $24.84 per share. There can be no assurance that the market for our common shares will become more liquid.
The stock market in general, and shares of early stage public companies in particular, have experienced extreme price and volume fluctuations
that have often been unrelated or disproportionate to the operating performance of such companies. If we are unable to increase the trading
volume for our common shares, you may not be able to sell your common shares at prices you consider to be fair or at times that are convenient
for you, or at all.

 Shares
eligible for future sale may adversely affect the market for our common stock.

 As
of the date of this report, virtually all of our outstanding shares are freely tradeable without restriction or are available for sale
pursuant to Rule 144 under the Securities Act. The market price of our common stock could decline as a result of sales of a large number
of shares of our common stock in the market or the perception that these sales could occur. Such sales or offerings could lower the market
price for our common stock and may make it more difficult for us to sell equity securities in the future at a time and at a price that
we deem appropriate. We may in the future sell additional shares of our common stock or equity-linked securities to raise capital. A
substantial number of shares of our common stock could be registered and issued. Furthermore, there are substantial amounts of vested
stock options which are "in the money" which could be exercised and sold in public markets. We continue to expect to issue
stock options as part of compensation. There may be further effect on our stock price upon the vesting and settlement of restricted stock
units and performance units. We cannot predict the size of future issuances or the effect, if any, that they may have on the market price
for our common stock. The issuance and sale of substantial amounts of common stock or equity-linked securities, or the perception that
such issuances and sales may occur, could adversely affect the trading price of our common stock and impair our ability to raise capital
through the sale of additional equity or equity-linked securities. Additional dilution may also result as a consequence of shares of
common stock sold pursuant to potential future offerings as well as if outstanding options to acquire shares of our common stock are
exercised.

 The
price of our common stock may fluctuate substantially.

 You
should consider an investment in our common stock to be risky, and you should invest in our common stock only if you can withstand a
significant loss and wide fluctuations in the market value of your investment. Some factors that may cause the market price of our common
stock to fluctuate, in addition to the other risks mentioned in this "Risk Factors" section and elsewhere in this report,
are:

 sale
 of our common stock by our stockholders, executives, and directors;

 volatility
 and limitations in trading volumes of our shares of common stock;

 our
 ability to obtain financings to conduct and complete research and development activities including, but not limited to, our proposed
 clinical trials, and other business activities;

 possible
 delays in the expected recognition of revenue due to lengthy and sometimes unpredictable product development and sales timelines;

 the
 timing and success of introductions of new technologies, therapeutic approaches, product candidates and product marketing applications
 by us or our competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors,
 customers or strategic partners;

 network
 outages or security breaches;

 the
 lack of market acceptance and sales growth for our drug candidates, if any, that receive marketing approval;

 our
 ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

 commencement,
 enrollment or results of our clinical trials for our drug candidates or any future clinical trials we may conduct;

 in the development status of our drug candidates;

 any
 delays or adverse developments or perceived adverse developments with respect to the FDA's review of our planned preclinical
 studies and clinical trials;

 any
 delay in our submission for studies or drug approvals or adverse regulatory decisions, including failure to receive regulatory approval
 for our drug candidates;

 unanticipated
 safety concerns related to the use of our drug candidates;

 failures
 to meet external expectations or management guidance;

 in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;

 our
 cash position;

 announcements
 and events surrounding financing efforts, including debt and equity securities;

 our
 inability to enter into new markets or develop new drugs;

 reputational
 issues;

 competition
 from existing technologies and drugs or new technologies and drugs that may emerge;

 announcements
 of acquisitions, partnerships, collaborations, joint ventures, new drugs, capital commitments, or other events by us or our competitors;

 in general economic, political and market conditions in any of the regions in which we conduct our business;

 in industry conditions or perceptions;

 in valuations of similar companies or groups of companies;

 analyst
 research reports, recommendations and changes in recommendations, price targets, and withdrawals of coverage;

 departures
 and additions of key personnel;

 disputes
 and litigations related to intellectual properties, proprietary rights, and contractual obligations;

 in applicable laws, rules, regulations, or accounting practices and other dynamics; and

 other
 events or factors, many of which may be out of our control.

 In
addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences
a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition
and results of operations. If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that,
even if unsuccessful, could be costly to defend and a distraction to management.

 We
have broad discretion in the use of our financial resources and may not use them effectively.

 Our
management has broad discretion in the application of our financial resources. Because of the number and variability of factors that
determine our use of our financial resources, their ultimate use may vary substantially from their currently intended use. Our management
may not apply our financial resources in ways that ultimately increase the value of any investment in our securities or enhance stockholder
value. The failure by our management to apply these funds effectively could harm our business. We have invested and may in the future
invest our cash in interest-bearing securities. These investments may not yield a favorable return to our stockholders. If we do not
invest or apply our cash in ways that enhance stockholder value, we may fail to achieve expected financial results, which may result
in a decline in the price of our shares of common stock, and, therefore, may negatively impact our ability to raise capital, invest in
or expand our business, acquire additional drugs or licenses, commercialize our drugs, or continue our operations.

 We
may acquire other companies or technologies, which could divert our management's attention, result in dilution to our stockholders
and otherwise disrupt our operations and adversely affect our operating results.

 We
may in the future seek to acquire or invest in businesses, product applications and services or technologies that we believe could complement
or expand our existing product candidates and business, enhance our technical capabilities or otherwise offer growth opportunities. The
pursuit of potential acquisitions may divert the attention of management and cause us to incur various expenses in identifying, investigating
and pursuing suitable acquisitions, whether or not they are consummated.

 In
addition, we do not have any experience in acquiring other businesses. If we acquire additional businesses, we may not be able to integrate
the acquired personnel, operations and technologies successfully or effectively manage the combined business following the acquisition.
We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:

 inability
 to integrate or benefit from acquired businesses, products, technologies or services in a profitable manner;

 unanticipated
 costs or liabilities associated with the acquisition;

 difficulty
 integrating the accounting systems, operations and personnel of the acquired business;

 difficulties
 and additional expenses associated with supporting legacy drugs and hosting infrastructure of the acquired business;

 difficulty
 maintaining the customers, if any, of the acquired business, including disparities in the revenue, licensing, support or business
 model of the acquired company;

 diversion
 of management's attention from other business concerns;

 adverse
 effects to our existing business relationships with business partners and customers, if any, as a result of the acquisition;

 the
 potential loss of key employees;

 use
 of resources that are needed in other parts of our business; and

 use
 of substantial portions of our available cash to consummate the acquisition.

 In
addition, a significant portion of the purchase price of companies we acquire may be allocated to acquired goodwill and other intangible
assets, which must be assessed for impairment at least annually. In the future, if our acquisitions do not yield expected returns, we
may be required to take charges to our operating results based on this impairment assessment process, which could adversely affect our
results of operations.

 Acquisitions
could also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating results.
In addition, if an acquired business fails to meet our expectations, our operating results, business and financial position may suffer.

and economic conditions, including inflation and changes in interest rates, may negatively impact our business, financial condition and
share price.

 Concerns
over inflation, energy costs, geopolitical issues, the U.S. mortgage market and real estate market, unstable global credit markets and
financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished liquidity and credit
availability, declines in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations
of slower global economic growth going forward, increased unemployment rates, and increased credit defaults in recent years. Our general
business strategy may be adversely affected by any such economic downturns, volatile business environments and continued unstable or
unpredictable economic and market conditions. If these conditions continue to deteriorate or do not improve, it may make any necessary
debt or equity financing more difficult to complete, more costly, and more dilutive. Failure to secure any necessary financing in a timely
manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance, and share price and
could require us to delay or abandon development or commercialization plans.

 Our
marketable securities have had and may in the future have their market value adversely affected due to rises in interest rates. While
we believe our cash, cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that
in the future our investments will not be subject to adverse changes in market value. We formed a wholly owned subsidiary, Lantern Pharma
Australia Pty Ltd, in Australia in September 2021 and experienced foreign currency losses of approximately $220,000 and $12,000 for the
years ended December 31, 2024 and 2023, respectively, in connection with this subsidiary. We will remain subject to the risk of foreign
currency losses in future periods, although we do not expect the impact of any foreign currency losses to be material.

 Inflation
generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect
on our results of operations during the periods presented in this report. Inflation has increased substantially in recent periods and
could have a greater impact on our future results of operations if it remains at current levels or continues to increase.

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

 The
trading market for our common stock will rely in part on the research and reports that industry or financial analysts publish about us,
our business, our markets and our competitors. We do not control these analysts. If securities analysts do not cover our common stock,
the lack of research coverage may adversely affect the market price of our common stock. Furthermore, if one or more of the analysts
who do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price
would likely decline. If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose
visibility in the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline
and may also impair our ability to expand our business with existing customers and attract new customers.

 Because
certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions
requiring stockholder approval.

 Our
directors, executive officers, and their respective affiliates, beneficially own approximately 8.2% of our outstanding shares of common
stock. As a result, these stockholders, acting together, would have the ability to substantially impact the outcome of matters submitted
to our stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially all
of our assets. In addition, these stockholders, acting together, would have the ability to substantially impact the management and affairs
of our company. Accordingly, this concentration of ownership might harm the market price of our common stock by:

 delaying,
 deferring or preventing a change in corporate control;

 impeding
 a merger, consolidation, takeover or other business combination involving us; or

 discouraging
 a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

 Future
sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could
cause our share price to fall.

 We
expect that significant additional capital will be needed in the future to continue our planned operations, including hiring new personnel,
advancing and commercializing our drug candidates, and continuing activities as an operating public company. To the extent we raise additional
capital by issuing equity securities; our stockholders may experience substantial dilution. We may sell common stock, convertible securities
or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock,
convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales.
Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing
stockholders.

 We
do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

 We
currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate
declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the increase,
if any, of our share price.

 We
are an "emerging growth company" and will be able to avail ourselves of reduced disclosure requirements applicable to emerging
growth companies, which could make our common stock less attractive to investors.

 We
are an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we
intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that
are not "emerging growth companies" including not being required to comply with the auditor attestation requirements of Section
404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements,
and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any
golden parachute payments not previously approved. In addition, Section 107 of the JOBS Act also provides that an "emerging growth
company" can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying
with new or revised accounting standards. In other words, an "emerging growth company" can delay the adoption of certain
accounting standards until those standards would otherwise apply to private companies. We have not elected to delay such adoption of
new or revised accounting standards, and as a result, we will comply with new or revised accounting standards on the relevant dates on
which adoption of such standards is required for non-emerging growth companies. We cannot predict if investors will find our common stock
less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may
be a less active trading market for our common stock and our stock price may be more volatile. We may take advantage of these reporting
exemptions until we are no longer an "emerging growth company." We will remain an "emerging growth company" until
the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the last
day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering, or December 31,
2025; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the
date on which we are deemed to be a large accelerated filer under the rules of the SEC.

 We
may be at risk of securities class action litigation.

 We
may be at risk of securities class action litigation. In the past, biotechnology and pharmaceutical companies have experienced significant
stock price volatility, particularly when associated with binary events such as clinical trials and drug approvals. If we face such litigation,
it could result in substantial costs and a diversion of management's attention and resources, which could harm our business and
result in a decline in the market price of our common stock.

 Our
certificate of incorporation and our by-laws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent
a change in control, which may cause our stock price to decline.

 Our
certificate of incorporation, and our by-laws, and Delaware law could make it more difficult for a third party to acquire us, even if
closing such a transaction would be beneficial to our stockholders. We are authorized to issue up to 1,000,000 shares of preferred stock.
This preferred stock may be issued in one or more series, the terms of which may be determined at the time of issuance by our board of
directors without further action by stockholders. The terms of any series of preferred stock may include voting rights (including the
right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking
fund provisions. None of our preferred stock is currently outstanding. The issuance of any preferred stock could materially adversely
affect the rights of the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights
granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party
and thereby preserve control by the present management.

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

 provide
 the board of directors with the ability to alter the by-laws without stockholder approval;

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

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

 Our
by-laws designate the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal
district court for the District of Delaware) as the exclusive forum for certain types of claims, which may limit a stockholder's
ability to bring a claim in a judicial forum that it finds favorable.

 Section
7.06 of our by-laws specifies that unless we consent in writing to the selection of an alternative forum, the court of Chancery of the
State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware)
shall, to the fullest extent permitted by law, be the sole and exclusive forum for: (a) any derivative action or proceeding brought on
our behalf; any action asserting a claim of breach of fiduciary duty owed by any of our directors, officers or other employees to us
or to our stockholders; (b) any action asserting a claim against us arising pursuant to the Delaware General Corporation Law ("DGCL")
or certificate of incorporation or our by-laws; or (c) or any action asserting a claim against us that is governed by the internal affairs
doctrine. There is uncertainty as to whether a court would enforce this provision with respect to claims under the Securities Act and
our stockholders cannot waive compliance with the federal securities laws and the rules and regulations thereunder. The exclusive forum
provision may limit a stockholder's ability to bring a claim in a judicial forum that it finds favorable for disputes against us
and our directors, officers and other employees, which may discourage such lawsuits, or may require increased costs to bring a claim.

 Financial
reporting obligations of being a public company in the United States require well defined disclosure and financial controls and procedures
that are expensive and time-consuming requiring our management to devote substantial time to compliance matters.

 As
a publicly traded company, we incur significant additional legal, accounting and other expenses that a privately held company is not
required to incur. For example, a privately held company is not required to have well defined disclosure and financial controls and procedures
or systems of internal controls over financial reporting that are generally required of publicly held companies. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives
of the control system are 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.

 These
reporting obligations associated with being a public company in the United States require significant expenditures and will place significant
demands on our management and other personnel, including costs resulting from our reporting obligations under the Securities Exchange
Act of 1934, as amended, (the "Exchange Act"), and the rules and regulations regarding corporate governance practices, including
those under the Sarbanes-Oxley Act of 2002, as amended, (the "Sarbanes-Oxley Act"), the Dodd-Frank Wall Street Reform and
Consumer Protection Act, as amended, (the "Dodd-Frank Act"), and the listing requirements of the stock exchange on which
our securities are to be listed. These rules require the establishment and maintenance of effective disclosure and financial controls
and procedures, internal control over financial reporting and changes in corporate governance practices, among many other complex rules
that are often difficult to implement, monitor and maintain compliance with. Moreover, despite recent reforms made possible by the JOBS
Act, the reporting requirements, rules, and regulations make some activities more time-consuming and costly, which will be particularly
true after we are no longer an "emerging growth company." In addition, we expect these rules and regulations will make it
more difficult and more expensive for us to obtain director and officer liability insurance. Our management and other personnel have
to devote a substantial amount of time to ensure that we comply with all of these requirements and to keep pace with new regulations,
otherwise we may fall out of compliance and risk becoming subject to litigation or being delisted, among other potential problems.

 If
we fail to comply with the rules under the Sarbanes-Oxley Act related to accounting controls and procedures in the future, or, if we
discover additional material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could
decline significantly and raising capital could be more difficult.

 Section
404 of the Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control over financial reporting
after a transition period ending with our second annual report on Form 10-K filed under Section 13(a) of the Exchange Act. If we fail
to comply with the rules under the Sarbanes-Oxley Act related to disclosure controls and procedures in the future, or, if in the future
we discover additional material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price
could decline significantly and raising capital could be more difficult.

 Comprehensive
tax reform bills could adversely affect our business and financial condition.

 The
U.S. government has in recent years enacted federal income tax legislation that includes significant changes to the taxation of business
entities. These changes include, among others, a permanent reduction to the corporate income tax rate. Notwithstanding the reduction
in the corporate income tax rate, the overall impact of this tax reform is uncertain, and our business and financial condition could
be adversely affected. This report does not discuss any such tax legislation or the manner in which it might affect purchasers of our
common stock. We urge our stockholders to consult with their legal and tax advisors with respect to any such legislation and the potential
tax consequences of investing in our common stock.

 Item
1B. Unresolved Staff Comments.

 None.

 Item
1C. Cybersecurity.

 Risk
Management and Strategy. We employ processes for assessing, identifying, and managing material risks
from cybersecurity threats that are incorporated into our overall risk management system. These items are designed to help protect our
information assets from internal and external threats and protect the integrity and confidentiality of our data. Our system includes
procedural and technical safeguards, response planning, and reviews of our policies. We engage various external entities, including consultants,
to improve and enhance our cybersecurity processes and oversight. We provide employees and consultants with cybersecurity and prevention
training including timely and relevant topics covering phishing, mobile security, and data protection and the need for reporting incidents
and suspicious events immediately.

 Although
we develop and maintain systems and controls designed to prevent cybersecurity threats from occurring, and we have a process to identify
and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring
and updating as technologies change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our
efforts, the possibility of these events occurring cannot be eliminated entirely. As we outsource more of our information systems to
vendors, engage in more electronic transactions with service providers and relating to patients participating in clinical trials, and
rely more on cloud-based information systems, the related security risks will increase and we will need to expend additional resources
to protect our technology and information systems. In addition, there can be no assurance that our internal information technology systems
or those of our third-party contractors, or our consultants' efforts to implement adequate security and control measures, will
be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction,
or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks or insider
threat attacks which could result in financial, legal, business or reputational harm.

 As
of the date of this report, we are not aware of any risks from cybersecurity threats, including as a result of any previous cybersecurity
incidents, that have materially affected or are reasonably likely to materially affect us, including our business strategy, results of
operations, or financial condition.

 Governance.
 Our senior management team conducts the regular assessment and management of material risks from cybersecurity threats, including review
with our information technology team and third-party service providers. All employees and consultants are directed to report to our senior
management any irregular or suspicious activity that could indicate a cybersecurity threat or incident. The Audit Committee of our Board
of Directors evaluates our cybersecurity assessment and management policies, including quarterly discussions with our senior officers
and independent registered accounting firm.

 Item
2. Properties.

 Our
principal executive office is located at 1920 McKinney Avenue, 7 th Floor, Dallas, Texas 75201. During 2024 and 2023, we leased
access to office space and meeting facilities at this location under month-to-month lease arrangements. We also leased additional office
space in the Dallas, Texas area and in the Atlanta, Georgia area under operating leases that commenced in May 2021. The Dallas operating
lease ends in November 2025, while the Atlanta operating lease ends in August 2026. Our operating lease expense was approximately $191,000
and $178,000 for the years ended December 31, 2024 and 2023, respectively.

 Item
3. Legal Proceedings.

 From
time to time in the future, we may become involved in litigation or other legal proceedings that arise in the ordinary course of business.
We are not currently a party to any legal proceedings, and we are not aware of any pending or threatened litigation against us that we
believe could have a material adverse effect on our business, operating results or financial condition. In the event we are subject to
a legal proceeding, it could have a material adverse impact on us because of litigation costs and diversion of management resources.

 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.

Information

 Our
common stock began trading on the Nasdaq Capital Market under the symbol "LTRN" on June 11, 2020. Prior to that date, there
was no public trading market for our common stock.

 Stockholders

 As
of March 17, 2025, there were 12 stockholders of record of our common stock. The actual number of holders of our common stock is greater
than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by
brokers or held by other nominees.

 Dividend
Policy

 We
have never paid or declared any cash dividends on our common stock, and we do not anticipate declaring or paying, in the foreseeable
future, any cash dividends on our capital stock. We intend to retain all available funds and future earnings, if any, to fund the development
and expansion of our business, and we do not anticipate paying any cash dividends in the foreseeable future. Any future determination
regarding the declaration and payment of dividends, if any, will be at the discretion of our board of directors and will depend on then-existing
conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects
and other factors our board of directors may deem relevant.

 Unregistered
Sales of Securities

 Options

 The
Company issued 20,000 shares of restricted common stock to a consultant with a grant date fair value of approximately $81,000 during
the year ended December 31, 2024.

 The
foregoing transactions did not involve any underwriters, underwriting discounts or commissions, or any public offering. We believe the
offers, sales and issuances of the above securities were exempt from registration under the Securities Act (or Regulation D promulgated
thereunder) by virtue of Section 4(a)(2) of the Securities Act because the issuance of securities to the recipients did not involve a
public offering. The recipients of the securities in each of these transactions represented their intentions to acquire the securities
for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed
upon the stock certificates issued in these transactions. The sales of these securities were made without any general solicitation or
advertising.

 Securities
Authorized for Issuance under Equity Compensation Plans

 The
table below contains information as of December 31, 2024 regarding the Second Amended and Restated Lantern Pharma Inc. 2018 Equity Incentive
Plan, as amended (the "Plan"). Additional information regarding the Plan is contained in Note 6 to our consolidated financial
statements included as part of this report. The Company does not have any equity compensation plans that have not been approved by stockholders.

 Plan
 category

 Number
 of securities to be issued upon exercise of outstanding options, warrants and rights

 Weighted-average
 exercise price of outstanding options, warrants and rights

 Number
 of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))

 (a)

 (b)

 (c)

 Equity
 compensation plans approved by security holders

 1,245,694
 shares of Common Stock

 $5.72
 per share

 423,693
 shares of Common Stock

 Equity
 compensation plans not approved by security holders

 N/A

 N/A

 N/A

 Total:

 1,245,694
 shares of Common Stock

 $5.72
 per share

 423,693
 shares of Common Stock

 Item
6. Reserved.

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

 You
should read the following discussion and analysis of our financial condition and plan of operations together with our financial statements
and the related notes appearing elsewhere in this Annual Report on Form 10-K. In addition to historical information, this discussion
and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially
from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified
below, and those discussed in Item 1A titled "Risk Factors" included elsewhere in this Annual Report on Form 10-K.

 We
are an artificial intelligence (A.I.) focused company dedicated to developing cancer therapies and transforming the cost, pace, and timeline
of oncology drug discovery and development. Our development portfolio includes three clinical stage oncology focused product candidates
and consists of small molecules that others have tried, but failed, to develop into an approved commercialized drug, as well as new compounds
that we are developing with the assistance of our proprietary A.I. platform and our biomarker driven approach. Our A.I. platform, known
as RADR, currently includes more than 100 billion data points, and uses big data analytics (combining molecular data,
drug efficacy data, data from historical studies, data from scientific literature, phenotypic data from trials and publications, and
mechanistic pathway data) and machine learning to rapidly uncover biologically relevant genomic signatures correlated to drug response,
and then identify the cancer patients that we believe may benefit most from our compounds. This data-driven, genomically-targeted and
biomarker-driven approach allows us to pursue a transformational drug development strategy that identifies, rescues or develops, and
advances potential small molecule drug candidates at what we believe is a fraction of the time and cost associated with traditional cancer
drug development.

 We
now have active clinical programs for our three lead
small molecule drug candidates: LP-300, LP-184, and LP-284. These programs are focused on multiple
important cancer indications, including both solid tumors and blood cancers. We have established a wholly-owned subsidiary, Starlight
Therapeutics, to focus exclusively on the clinical development of our promising opportunities for central nervous system (" CNS")
and brain cancers, many of which have no effective treatment options. We are also advancing an antibody-drug conjugate ("ADC")
program focused on developing highly specific ADCs with highly potent drug-payloads.

 Our
strategy is to both develop new drug candidates using our RADR platform, and other machine learning driven methodologies,
and to pursue the development of drug candidates that have undergone previous clinical trial testing or that may have been halted in
development or deprioritized because of insufficient clinical trial efficacy (i.e., a meaningful treatment benefit relevant for the disease
or condition under study as measured against the comparator treatment used in the relevant clinical testing) or for strategic reasons
by the owner or development team responsible for the compound. Importantly, these historical drug candidates appear to have been well-tolerated
in many instances, and often have considerable data from previous toxicity, tolerability and ADME (absorption, distribution, metabolism,
and excretion) studies that have been completed. Additionally, these drug candidates may also have a body of existing data supporting
the potential mechanism(s) by which they achieve their intended biologic effect, but often require more targeted trials in a stratified
group of patients to demonstrate statistically meaningful results. Our dual approach to both develop de-novo, biomarker-guided drug candidates
and "rescue" historical drug-candidates by leveraging A.I., recent advances in genomics, computational biology and cloud
computing is emblematic of a new era in drug development that is being driven by data-intensive approaches meant to de-risk development
and accelerate the clinical trial process. In this context, we intend to create a diverse portfolio of oncology drug candidates for further
development towards regulatory and marketing approval with the objective of establishing a leading A.I.-driven methodology for treating
the right patient with the right oncology therapy.

 A
key component of our strategy is to target specific cancer patient populations and treatment indications identified by leveraging our
RADR platform, a proprietary A.I. enabled engine created and owned by us. We believe the combination of our therapeutic
area expertise, our A.I. expertise, and our ability to identify and develop promising drug candidates through our collaborative relationships
with research institutions in selected areas of oncology gives us a significant competitive advantage. Our RADR platform
has been developed and refined over the last several years and integrates billions of data points immediately relevant for oncology drug
development and patient response prediction using artificial intelligence and proprietary machine learning algorithms. By identifying
clinical candidates, together with relevant genomic and phenotypic data, we believe our approach will help us design more efficient pre-clinical
studies, and more targeted clinical trials, thereby accelerating our drug candidates' time to approval and eventually to market.
Although we have not yet applied for or received regulatory or marketing approval for any of our drug candidates, we believe our RADR
 platform has the ability to reduce the cost and time to bring drug candidates to specifically targeted patient groups. We believe
we have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that
leverages artificial intelligence along with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic
areas to address today's treatment needs.

 Our
current portfolio consists of three lead drug candidates that are in clinical phases (known as LP-300, LP-184 and LP-284) and an Antibody
Drug Conjugate (ADC) program that is in preclinical research optimization. In January 2023, we formed a wholly owned subsidiary, Starlight
Therapeutics Inc. ("Starlight"), to develop drug candidate LP-184's central nervous system (CNS) and brain cancer indications
– including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers. Following the formation
of Starlight, we may also refer to the molecule LP-184, as it is developed in CNS indications, as "STAR-001". All of these
drug candidates and our ADC program are leveraging precision oncology, A.I. and genomic driven approaches to accelerate and direct development
efforts.

 We
are conducting a targeted phase 2 trial (the Harmonic trial) for LP-300 in never smoking patients with NSCLC in combination with
chemotherapy, under an existing investigational new drug application. Our candidate LP-184 has shown promising in-vitro and in
vivo anticancer activity in multiple solid tumor indications (including pancreatic, glioblastoma and triple negative breast cancer),
and it is advancing in a Phase 1A clinical trial. Our candidate LP-284 has shown promising in-vitro and
 in vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184. LP-284
is advancing in a Phase 1A clinical trial that commenced in the fourth quarter of 2023.

 Our
ADC program has also continued to advance. During 2024, we continued to progress the application of our RADR
A.I. platform to advance and refine an A.I. powered module focused on improving the precision, cost and timelines of ADC development for
cancer. In 2023, we entered into a research collaboration with
Bielefeld University in Germany focused on development of ADCs utilizing cryptophycin as the ADC drug-payload. Cryptophycins are promising
antitumor molecules that have demonstrated potency at ultra-low, picomolar, concentrations. In a broad range of preclinical studies,
the cryptophycin-ADC synthesized as part of the Bielefeld collaboration demonstrated promising
picomolar level potency and anti-tumor activity in multiple solid tumor cell lines, including breast, bladder, colorectal, gastric, pancreatic
and ovarian.

 In
addition to our lead drug candidates and ADC program, we also have an additional drug candidate, LP-100, that we believe has potential
for future development in combination with the class of anticancer agents known as PARP inhibitors (PARPi). For LP-100, as well as our
lead drug candidate LP-300, we are leveraging data from prior preclinical studies and clinical trials, along with insights generated
from our A.I. platform, to target the types of tumors and patient groups we believe will be most responsive to the drug. Both LP-100
and LP-300 showed promise in important patient subgroups, but failed pivotal Phase 3 trials when the overall results did not meet the
predefined clinical endpoints. We believe that this was due to a lack of biomarker-driven patient stratification.

has been studied in multiple randomized, controlled, multi-center non-small cell lung cancer, or NSCLC, trials that included administration
of either paclitaxel and cisplatin and/or docetaxel and cisplatin. LP-100 has previously been in a genomic signature guided phase 2 clinical
trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC). 9 patients (out of a targeted enrollment
of 27) were treated in the trial. The median overall survival (OS) for the initial group of 9 patients was approximately 12.5 months,
which is an improvement over other similar fourth-line treatment regimens for mCRPC. Based on our evaluation of the synergies of LP-100
with PARP inhibitors, the decision was made in the first quarter of 2023 to close the phase 2 clinical trial in Denmark, to allow the
focus of LP-100-directed resources on positioning the molecule for development in earlier lines of therapy with potentially larger market
opportunities. LP-100 was previously out-licensed by us to Allarity Therapeutics A/S. In July 2021, we entered into an Asset Purchase
Agreement to reacquire global development and commercialization rights for LP-100 from Allarity.

 Our
development strategy is to pursue an increasing number of oncology focused, molecularly targeted therapies where artificial intelligence
and genomic data can help us provide biological insights, reduce the risk associated with development efforts and help clarify potential
patient response. We plan on strategically evaluating these on a program-by-program basis as they advance into clinical development,
either to be done entirely by us, or with licensing partners, to maximize the commercial opportunity and reduce the time it takes to
bring the right drug to the right patient.

 To
date, except for a prior research grant, we have not generated any revenue, we have incurred net losses and our operations have been
financed primarily by sales of our equity securities. Our net losses were approximately $20,781,000 and $15,962,000 for the years ended
December 31, 2024 and 2023, respectively.

 Our
net losses have primarily resulted from costs incurred in licensing and developing the drug candidates in our pipeline, planning, preparing
and conducting preclinical studies and clinical testing, and general and administrative activities associated with our operations. We
expect to continue to incur significant expenses and corresponding increased operating losses for the foreseeable future as we continue
to develop our pipeline. Our costs may further increase as we conduct additional preclinical studies and clinical trials and potentially
seek regulatory clearance for and prepare to commercialize our drug candidates. We expect to incur significant expenses to continue to
build the infrastructure necessary to support our expanded operations, preclinical studies, clinical trials, and commercialization, including
manufacturing, marketing, sales and distribution functions. We have experienced and will continue to experience substantial costs associated
with operating as a public company.

 Components
of Our Results of Operations

 Revenues

 We
did not recognize revenues for the years ended December 31, 2024 and December 31, 2023.

and Development

and development expenses consist primarily of costs incurred for the research and development of our preclinical and clinical candidates,
which include:

 expenses
 incurred towards research and development employees, consultants, outside contractors, laboratories, clinical sites, and investigators
 that conduct our preclinical or clinical research activities; and

 the
 cost of acquiring and developing preclinical and clinical study materials and lab supplies, including manufacturing costs related
 to our drug candidates.

 We
expense research and development costs to operations as incurred.

 Our
research and development costs by project category for the years ended December 31, 2024 and 2023 are as follows:

 Year Ended
 December 31, 2024

 Year Ended
 December 31, 2023

 $
 4,483,240

 $
 3,532,730

 7,201,286

 4,359,872

 2,192,287

 2,219,492

 63,760

 123,949

 ADC Program

 156,211

 248,665

 RADR Platform

 1,211,709

 976,240

 Other

 817,197

 433,367

 Total research and development expenses

 $
 16,125,690

 11,894,315

 We
expect that our research and development expenses will fluctuate from quarter to quarter and year to year. We
expect that our research and development expenses will increase substantially over time based on the progress of our clinical trials
for LP-300, LP-184 and LP-284, and other programs and drug candidates. We expect to make substantial expenditures associated with
research and service provider agreements for the advancement of our drug candidates and research and development efforts.

 Because
of the numerous risks and uncertainties associated with product development, we cannot determine with certainty the duration and completion
costs of these or other current or future clinical trials of LP-300, LP-184, LP-284 or our other drug candidates. We may never succeed
in achieving regulatory approval for LP-300, LP-184, LP-284 or any of our other drug candidates. The duration, costs and timing of clinical
trials and development of our drug candidates will depend on a variety of factors, including the uncertainties of future clinical and
preclinical studies, uncertainties in clinical trial enrollment rates, significant and changing government regulation, and geopolitical
risk, including in Taiwan where we are pursuing clinical testing of LP-300. In addition, the probability of success for each drug candidate
will depend on numerous factors, including competition, manufacturing capability and commercial viability.

and Administrative

and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, corporate
development and administrative support functions, including stock-based compensation expenses and benefits. Other significant general
and administrative expenses include accounting and legal services, insurance, the cost of various consultants, occupancy costs, investor
relations and information systems costs.

 We
expect increased administrative costs resulting from our existing and anticipated clinical trials and the potential commercialization
of our drug candidates. We believe that these increases will likely include increased costs for hiring additional administrative personnel
to support future market research and future product commercialization efforts and increased fees for outside consultants, attorneys
and accountants.

 Summary
Results of Operations for the Years Ended December 31, 2024 and December 31, 2023

 For the Year Ended

 2024

 2023

 Operating expenses:

 General and administrative

 $
 6,090,747

 $
 5,983,255

 Research and development

 16,125,690

 11,894,315

 Total operating expenses

 22,216,437

 17,877,570

 Loss from operations

 (22,216,437
)

 (17,877,570
)

 Interest income

 742,355

 765,388

 Other income, net

 692,869

 1,150,648

 NET LOSS

 $
 (20,781,213
)

 $
 (15,961,534
)

 Comparison
of the Years Ended December 31, 2024 and December 31, 2023

and Administrative Expenses

and administrative expenses increased approximately $108,000, or 2%, from approximately $5,983,000 for the year ended December 31,
2023 to approximately $6,091,000 for the year ended December 31, 2024. The increase was primarily attributable to increases in other
professional fees of approximately $395,000, offset, in part, by a decrease in wage and benefit costs of approximately $108,000 due to
a decline in stock-based compensation and a decrease in insurance expenses of approximately $185,000.

and Development Expenses

and development expenses increased approximately $4,232,000, or 36%, from approximately $11,894,000 for the year ended December 31, 2023
to approximately $16,126,000 for the year ended December 31, 2024. The increase was primarily attributable to increases in research studies
of approximately $2,947,000 relating to the conduct and support of our clinical trials, increases in contract labor expenses of approximately
$376,000 and increases in research and development wages and benefit expenses of approximately $897,000.

 Interest
Income and Other Income

 Interest
income decreased approximately $23,000 from approximately $765,000 during the year ended December 31, 2023 to approximately $742,000
for the year ended December 31, 2024. This decrease in interest income was offset, in part, by an increase in non-cash income of approximately
$99,000 during the year ended December 31, 2024, due to an increase in accretion of bond discounts. During the years ended December 31,
2024 and 2023, we generated interest income (excluding non-cash income) of approximately $472,000 and $592,000, respectively, from our
cash and cash equivalents and marketable securities.

 Other
income, net decreased approximately $458,000 from approximately $1,151,000 for the year ended December 31, 2023 to approximately $693,000
for the year ended December 31, 2024. This decrease was primarily driven by a decrease in Australian research and development tax incentives
of approximately $404,000 during the year ended December 31, 2024, as a result of completion of animal studies relating to our Phase
1 clinical trials that resulted in reduced activity in our Australian subsidiary. We also reported an increase in foreign currency translation
loss of approximately $208,000 and a decrease in dividend income of approximately $28,000 during the year ended December 31, 2024 compared
to the year ended December 31, 2023. These reductions in other income, net, were offset, in part by an increase in net appreciation in
the fair value of marketable securities of approximately $182,000 during the year ended December 31, 2024.

 Liquidity
and Capital Resources

 We
incurred net losses of approximately $20,781,000 and $15,962,000 for the years ended December 31, 2024 and 2023, respectively. As of
December 31, 2024, we had working capital of approximately $20,916,000.

 We have
not yet generated any revenues from operations, other than revenues from a research grant, and we have not yet achieved profitability.
We expect that we will need substantial additional funding in the near future, and if we are unable to raise capital when needed, we could
be forced to delay, reduce or eliminate our drug development programs or commercialization efforts. We expect that general and administrative
expenses and our research and development expenses will fluctuate from quarter to quarter. In order to achieve profitability, we will
need to generate significant product revenues, which could be several years in the future. We may never achieve significant product revenues
or profitability.

 Since
our inception, our operations have been financed primarily through the sale of equity securities, and, to a much lesser extent, funds
received by us from the PPP Loan and a 2017 grant from the Massachusetts Life Sciences Center. We plan to apply for grant funding in
the future to assist in supporting our capital needs. We may also explore the possibility of entering into commercial credit facilities
as an additional source of liquidity.

the year ended December 31, 2023, we repurchased 145,348 shares of our common stock for approximately $500,000. No shares were repurchased
in 2024.

 As
of December 31, 2024 and 2023, we had cash and cash equivalents of approximately $7,511,000 and $21,938,000, respectively. Based on our
anticipated expenditures and capital commitments as of the date of this report, we believe that our existing cash, cash equivalents,
and marketable securities as of December 31, 2024 will enable us to fund our operating expenses and capital expenditure requirements
for at least 12 months from the date of filing this Form 10-K. As of December 31, 2024 and 2023, we had marketable securities of approximately
$16,502,000 and $19,365,000, respectively.

 Cash
Flows

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

 For the Year ended

 2024

 2023

 Net cash flows used in operating activities

 $
 (17,813,201
)

 $
 (14,346,548
)

 Net cash flows provided by (used in) investing activities

 3,369,368

 (930,210
)

 Net cash flows provided by (used in) financing activities

 66,710

 (499,997
)

 Effect of foreign exchange rates on cash

 (49,547
)

 (28,462
)

 Net decrease in cash and cash equivalents

 $
 (14,426,670
)

 $
 (15,805,217
)

 Operating
Activities

 For
the year ended December 31, 2024, net cash used in operating activities was approximately $17,813,000 compared to approximately $14,347,000
for the year ended December 31, 2023. The increase in net cash used in operating activities was primarily the result of the increase
of approximately $4,820,000 in the net loss for the year ended December 31, 2024 as compared to the year ended December 31, 2023, offset
in part by an increase in accounts payable and accrued expenses of approximately $1,636,000.

 Investing
Activities

 For
the year ended December 31, 2024, net cash provided by investing activities was approximately $3,369,000 compared to net cash used of
approximately $930,000 for the year ended December 31, 2023. The change is primarily a result of investing in more short-term securities
that are considered cash and cash equivalents during the year ended December 31, 2024 than we did during the year ended December 31,
2023.

 Financing
Activities

 For
the year ended December 31, 2024, net cash provided by financing activities was approximately $67,000 compared to net cash used of approximately
$500,000 for the year ended December 31, 2023. The change is primarily due to share repurchases during the year ended December 31, 2023.

 Operating
Capital and Capital Expenditure Requirements

 We
expect to continue to incur significant and often increasing operating losses at least for the next several years as we continue our
clinical development of LP-300, LP-184 and LP-284, pursue development of our other drug candidates and programs, and seek potential
future marketing approval for our drug candidates, which could be several years in the future, if at all. We do not expect to
generate revenue, other than possible license and grant revenue, unless and until we successfully complete development and obtain
regulatory approval for our therapeutic candidates. Our net losses may fluctuate significantly from quarter-to-quarter and
year-to-year, depending on the timing of our existing and planned clinical trials and our expenditures on other research and
development activities.

 We
have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our
available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development
and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. We
anticipate that our expenses will increase substantially as we:

 the development, including preclinical studies and clinical trials, of our drug candidates;

 initiate
 preclinical studies and clinical trials for any additional indications for our current drug candidates and any future drug candidates
 that we may pursue;

 to build our portfolio of drug candidates through the acquisition or in-license of additional drug candidates or technologies;

 to develop, maintain, expand and protect our intellectual property portfolio;

 pursue
 regulatory approvals for those of our current and future drug candidates that successfully complete clinical trials;

 ultimately
 establish a sales, marketing, distribution and other commercial infrastructure to commercialize any drug candidate for which we may
 obtain marketing approval;

 hire
 additional clinical, regulatory, scientific and accounting personnel;

 incur
 additional legal, accounting and other expenses in operating as a public company; and

 to develop, maintain, and expand our RADR platform.

 We
expect that we will need to obtain substantial additional funding in order to complete our clinical trials. To the extent that we raise
additional capital through the sale of common stock, convertible securities or other equity securities, the ownership interests of our
existing stockholders may be materially diluted and the terms of these securities could include liquidation or other preferences that
could adversely affect the rights of our existing stockholders. In addition, debt financing, if available, would result in increased
fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions,
such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct
our business. If we are unable to raise capital when needed or on attractive terms, we could be forced to significantly delay, scale
back or discontinue the development or commercialization of LP-300, LP-184, LP-284, and/or other drug candidates and programs, seek collaborators
at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, and relinquish
or license, potentially on unfavorable terms, our rights to LP-300, LP-184, LP-284, and/or other drug candidates and programs that we
otherwise would seek to develop or commercialize ourselves.

 Critical
Accounting Estimates

 We
prepare our consolidated financial statements in accordance with generally accepted accounting standards in the United States of America.
Our significant accounting policies are described in Note 3 to our consolidated financial statements included as part of this report.
Critical accounting policies and significant accounting estimates made in accordance with such policies are regularly discussed with
the Audit Committee of the Company's board of directors. We believe the following critical accounting policies involve the most
significant judgments and estimates used in the preparation of the consolidated financial statements.

and Development

 All
costs of research and development are expensed as incurred.

 When
preparing our financial statements, we are required to estimate our accrued clinical expenses. This process involves reviewing contracts
and communicating with our personnel and third party vendors to identify services that have been performed on our behalf and estimating
the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified
of actual cost. Payments under some of the contracts we have with third parties depend on factors, such as successful enrollment of certain
numbers of patients, site initiation and the completion of clinical trial milestones.

 When
accruing clinical expenses, we estimate the time period over which services will be performed and the level of effort to be expended
in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be
required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost
associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future
periods. Historically, our estimated accrued clinical expenses have generally approximated actual expense incurred.

 Stock-based
Compensation

 We
have granted stock options to our employees under our equity incentive plan. Stock-based compensation expense from awards granted under
our plan is allocated over the required service period over which those stock option awards vest. Forfeitures are accounted for as they
occur.

 The
stock option awards are valued at fair value on the date of grant and that fair value is recognized over the requisite service period.
The estimated fair value of these stock option awards was determined using the Black Scholes option pricing model on the date of grant.
Some of these grants occurred at a time when we were not a public company. Significant judgment and estimates were used to estimate the
fair value of these awards, as they occurred when our stock was not publicly traded.

 Each
option award is subject to specified vesting schedules and requirements. Compensation expense is charged to us over the required service
period to earn the award which is expected to be up to four years, subject to the achievement of time and event-based vesting requirements.
For the years ended December 31, 2024 and 2023, we have incurred share-based compensation expense related to equity awards totaling approximately
$733,000 and $1,068,000, respectively.

 Quantitative
and Qualitative Disclosure About Market Risk

 Our
primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates.
 Fixed rate securities may have their market value adversely affected due to a rise in interest
rates. Accordingly, our future investment income may fluctuate as a result of changes in interest rates, or we may suffer losses in principal
if we are forced to sell securities that decline in market value as a result of changes in interest rates.

 Historically,
we have raised capital through the issuance of equity securities. We had no long-term debt outstanding as of December 31, 2024 and 2023.

 We
do not believe that our cash and cash equivalents have significant risk of default or illiquidity. Our
cash and cash equivalents consist primarily of cash and money market funds. Our exposure to market risk relating to cash and cash equivalents
due to changes in interest rates is limited because our cash and cash equivalents have a short-term maturity and are used primarily for
working capital purposes. Our marketable securities have had and may in the future have their market value adversely affected
due to rises in interest rates. While we believe our cash, cash equivalents and marketable securities do not contain excessive risk,
we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. In addition,
we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured
limits. Interest bearing and non-interest bearing accounts we hold at banking institutions are guaranteed by the Federal Deposit Insurance
Corporation ("FDIC") up to $250,000. Substantially all of our cash balances held at banking institutions are in excess of
FDIC coverage. We consider this to be a normal business risk.

 We
formed a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia in September 2021 and experienced foreign currency losses
of approximately $220,000 and $12,000 for the years ended December 31, 2024 and 2023, respectively, in connection with this subsidiary.
We will remain subject to the risk of foreign currency losses in future periods, although we do not expect the impact of any foreign
currency losses to be material. We do not participate in any foreign currency hedging activities, and we do not have any other derivative
financial instruments.

 Inflation
generally affects us by increasing our cost of labor and clinical trial costs. We do not believe that inflation has had a material effect
on our results of operations during the periods presented. Inflation could have a greater impact on our future results of operations
if it remains at current levels or increases further.

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

 As
a Smaller Reporting Company, we are exempt from the requirements of Item 7A.

 Item
8. Financial Statements and Supplementary Data.

 LANTERN
PHARMA INC.

TO FINANCIAL STATEMENTS

 Report of Independent Registered Public Accounting Firm (PCAOB ID No. 274)

 Consolidated Balance Sheets – December 31, 2024 and 2023

 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Stockholders' Equity for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Cash Flow for the Years Ended December 31, 2024 and 2023

 Notes to Consolidated Financial Statements

 F- 1

 REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 To
the Board of Directors and Stockholders of

 Opinion
on the Financial Statements

 We
have audited the accompanying consolidated balance sheets of Lantern Pharma Inc. and Subsidiaries (the "Company") as of December
31, 2024 and 2023, and the related consolidated statements of operations, comprehensive loss, stockholders' equity, and
cash flows for each of 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 consolidated financial position of the Company
as of December 31, 2024 and 2023, and the consolidated results of their operations and their cash flows for each of 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.

 /s/
 EisnerAmper LLP

 We
have served as the Company's auditor since 2018.

 EISNERAMPER
LLP

 Philadelphia, Pennsylvania

 March

 F- 2

Balance Sheets

 2024

 2023

 CURRENT ASSETS

 Cash and cash equivalents

 $
 7,511,079

 $
 21,937,749

 Marketable securities

 16,501,984

 19,364,923

 Prepaid expenses & other current assets

 1,234,566

 2,038,653

 Total current assets

 25,247,629

 43,341,325

 Property and equipment, net

 47,440

 52,127

 Operating lease right-of-use assets

 239,985

 228,295

 Other assets

 36,738

 25,869

 TOTAL ASSETS

 $
 25,571,792

 $
 43,647,616

 CURRENT LIABILITIES

 Accounts payable and accrued expenses

 $
 4,140,361

 $
 2,505,211

 Operating lease liabilities, current

 190,814

 172,975

 Total current liabilities

 4,331,175

 2,678,186

 Operating lease liabilities, net of current portion

 52,843

 61,496

 TOTAL LIABILITIES

 4,384,018

 2,739,682

 COMMITMENTS AND CONTINGENCIES (NOTE 4)

 -

 -

 STOCKHOLDERS' EQUITY

 Preferred Stock ( 1,000,000 authorized at December 31, 2024 and December 31, 2023; $.0001 par value)
 ( Zero shares issued and outstanding at December 31, 2024 and December 31, 2023)

 -

 -

 Common Stock ( 25,000,000 authorized at December 31, 2024 and December 31, 2023; $.0001 par value)
 ( 10,784,725 shares issued and outstanding at December 31, 2024; 10,721,192 shares issued and outstanding at December 31, 2023)

 1,078

 1,072

 Additional paid-in capital

 97,058,323

 96,258,726

 Accumulated other comprehensive income (loss)

 153,990

 ( 107,460
)

 Accumulated deficit

 ( 76,025,617
)

 ( 55,244,404
)

 Total stockholders' equity

 21,187,774

 40,907,934

 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 $
 25,571,792

 $
 43,647,616

 See

 F- 3

Statements of Operations

 For
 the Year Ended
 December
 31,

 2024

 2023

 Operating expenses:

 General and administrative

 $
 6,090,747

 $
 5,983,255

 Research and development

 16,125,690

 11,894,315

 Total operating expenses

 22,216,437

 17,877,570

 Loss from operations

 ( 22,216,437
)

 ( 17,877,570
)

 Interest income

 742,355

 765,388

 Other income, net

 692,869

 1,150,648

 NET LOSS

 $
)

 $
)

 Net loss per share of common shares, basic and diluted

 $
 ( 1.93
)

 $
 ( 1.47
)

 Weighted-average number of common shares outstanding, basic and diluted

 10,762,319

 10,842,365

 See

 F- 4

Statements of Comprehensive Loss

 For the Year Ended

 2024

 2023

 NET LOSS

 $
)

 $
)

 Other comprehensive gain

 Unrealized gain on available-for-sale securities

 115,761

 282,252

 Unrealized gain (loss) on foreign currency translation

 145,689

 ( 18,326
)

 Other comprehensive gain

 261,450

 263,926

 Comprehensive loss

 $
 ( 20,519,763
)

 $
 ( 15,697,608
)

 See

 F- 5

Statements of Stockholders' Equity (Deficit)

 Preferred
 Stock
 Number
 of
 Shares

 Preferred
 Stock
 Amount

 Common
 Stock
 Number
 of
 Shares

 Common
 Stock
 Amount

 Paid-in
 Capital

 Accumulated
 Other
 Comprehensive
 Income
 (Loss)

 Accumulated
 Deficit

 Total
 Stockholders'
 Equity

 Balance, January 1, 2023

 -

 $
 -

 10,857,040

 $
 1,086

 $
 95,691,194

 $
 ( 371,386
)

 $
 ( 39,282,870
)

 $
 56,038,024

 Issuance of restricted common stock awards

 -

 -

 12,000

 50,064

 -

 -

 50,065

 Cancellation of restricted common stock awards

 -

 -

 ( 2,500
)

 -

 -

 -

 -

 -

 Share repurchase

 -

 -

 ( 145,348
)

 ( 15
)

 ( 499,982
)

 -

 -

 ( 499,997
)

 -

 -

 -

 -

 1,017,450

 -

 -

 1,017,450

 Net loss

 -

 -

 -

 -

 -

 -

)

)

 Other comprehensive gain

 -

 -

 -

 -

 -

 263,926

 -

 263,926

 Balance December 31, 2023

 -

 $
 -

 10,721,192

 $
 1,072

 $
 96,258,726

 $
 ( 107,460
)

 $
 ( 55,244,404
)

 $
 40,907,934

 Balance

 -

 $
 -

 10,721,192

 $
 1,072

 $
 96,258,726

 $
 ( 107,460
)

 $
 ( 55,244,404
)

 $
 40,907,934

 Issuance of restricted common stock awards

 -

 -

 20,000

 80,798

 -

 -

 80,800

 Proceeds from warrant exercises

 -

 -

 43,533

 66,706

 -

 -

 66,710

 -

 -

 -

 -

 652,093

 -

 -

 652,093

 Net loss

 -

 -

 -

 -

 -

 -

)

)

 Other comprehensive gain

 -

 -

 -

 -

 -

 261,450

 -

 261,450

 Balance, December 31, 2024

 -

 $
 -

 10,784,725

 $
 1,078

 $
 97,058,323

 $
 153,990

 $
 ( 76,025,617
)

 $
 21,187,774

 Balance

 -

 $
 -

 10,784,725

 $
 1,078

 $
 97,058,323

 $
 153,990

 $
 ( 76,025,617
)

 $
 21,187,774

 See

 F- 6

Statements of Cash Flows

 2024

 2023

 CASH FLOWS FROM OPERATING ACTIVITIES

 Net loss

 $
)

 $
)

 Adjustments to reconcile net loss to cash used in operating activities:

 Depreciation and amortization

 17,282

 14,615

 Accretion of investment discounts

 ( 238,574
)

 ( 173,086
)

 Non-cash lease adjustments

 173,211

 160,228

 732,893

 1,067,515

 Foreign currency remeasurement loss

 219,729

 11,500

 Realized (gain) loss on sale of marketable debt securities

 ( 9,065
)

 115,840

 Unrealized gain on marketable equity securities

 ( 155,624
)

 ( 119,650
)

 Changes in assets and liabilities:

 Operating lease liabilities

 ( 175,715
)

 ( 159,255
)

 Prepaid expenses & other current assets

 778,304

 941,440

 Accounts payable and accrued expenses

 1,636,440

 ( 236,181
)

 Other assets

 ( 10,869
)

 ( 7,980
)

 Net cash flows used in operating activities

 ( 17,813,201
)

 ( 14,346,548
)

 INVESTING ACTIVITIES

 Purchase of property and equipment

 ( 12,595
)

 ( 18,734
)

 Purchase of marketable securities

 ( 17,275,680
)

 ( 8,196,143
)

 Redemptions of marketable securities

 20,657,643

 7,284,667

 Net cash flows provided by (used in) investing activities

 3,369,368

 ( 930,210
)

 FINANCING ACTIVITIES

 Proceeds from warrant and stock option exercises

 66,710

 -

 Repurchases of shares including commissions

 -

 ( 499,997
)

 Net cash flows provided by (used in) financing activities

 66,710

 ( 499,997
)

 Effect of foreign exchange rates on cash

 ( 49,547
)

 ( 28,462
)

 CHANGE IN CASH AND CASH EQUIVALENTS FOR THE YEAR

 ( 14,426,670
)

 ( 15,805,217
)

 CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR

 21,937,749

 37,742,966

 CASH AND CASH EQUIVALENTS, END OF YEAR

 $
 7,511,079

 $
 21,937,749

 Non-cash investing and financing activities:

 Operating lease right-of-use asset acquired through operating lease liability

 $
 348,623

 $
 141,989

 Remeasurement of operating lease right-of-use asset and operating lease liability

 -

 198,847

 Removal of operating lease right-of-use assets and related operating lease liabilities upon early termination
 of leases

 163,722

 -

 See

 F- 7

 NOTES
TO FINANCIAL STATEMENTS

 Note
1. Organization, Principal Activities, and Basis of Presentation

Pharma Inc., and Subsidiaries (the "Company") is an artificial intelligence (A.I.) focused company dedicated to developing
cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development. The Company's development
portfolio includes three clinical stage oncology focused product candidates and consists of small molecule drug candidates that others
have tried, but failed, to develop into an approved commercialized drug, as well as new compounds that it is developing with the assistance
of its A.I. platform and its biomarker driven approach. The Company's A.I. platform, known as RADR, uses big data
analytics (combining molecular data, drug efficacy data, data from historical studies, data from scientific literature, phenotypic data
from trials and publications, and mechanistic pathway data) and machine learning. The Company's data-driven, genomically-targeted
and biomarker-driven approach allows it to pursue a transformational drug development strategy that identifies, rescues or develops,
and advances potential small molecule drug candidates.

Pharma Inc. was incorporated under the laws of the state of Texas on November 7, 2013, and thereafter reincorporated in the state of
Delaware on January 15, 2020. The Company's principal operations are located in Texas. The Company formed a wholly owned subsidiary,
Lantern Pharma Limited, in the United Kingdom in July 2017 and a wholly owned subsidiary, Lantern Pharma Australia Pty Ltd, in Australia
in September 2021. In January 2023, the Company formed a wholly owned subsidiary, Starlight Therapeutics Inc. ("Starlight"),
to continue with advancing the development of drug candidate LP-184's central nervous system (CNS) and brain cancer indications.

 Since
inception, the Company has devoted substantially all its activity to advancing research and development, including efforts in connection
with preclinical studies, clinical trials and development of its RADR platform. This now includes three lead drug candidates
and an Antibody Drug Conjugate (ADC) program directed towards 11 disclosed therapeutic targets:

 (Tavocept), which we are advancing in a Phase 2 clinical trial, the Harmonic trial, focused on never smokers with
 advanced non-small cell lung cancer;

 LP-184,
 which we are advancing in a Phase 1 clinical trial, and has potential for treatment of solid tumors including breast, pancreatic,
 bladder, and lung cancers, and glioblastoma and other CNS cancers. Following the formation of Starlight, the Company now refers to
 the molecule LP-184, as it is developed in CNS indications, as "STAR-001";

 LP-284,
 the stereoisomer (enantiomer) of LP-184, is advancing in a Phase 1 clinical trial, and has shown promising in-vitro and in
 vivo anticancer activity in multiple hematological cancers, which are distinct from the indications targeted by LP-184; and

 Our
 ADC program is focused on developing highly specific ADCs with highly potent drug-payloads.

 The
Company's fiscal year ends on December 31 of each calendar year. The accompanying consolidated financial statements have been prepared
in accordance with accounting principles generally accepted in the United States of America ("GAAP") and include all adjustments
necessary for the fair presentation of the Company's financial position, results of operations, and cash flows for each period
presented. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of expenses during the reporting periods. Actual results could differ from these estimates.

 F- 8

 Any
reference in these notes to applicable guidance refers to Accounting Standards Codification ("ASC") and Accounting Standards
Update ("ASU") of the Financial Accounting Standards Board ("FASB"). To date, the Company has operated its business
as one segment. The Company's consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries,
Lantern Pharma Limited, Starlight Therapeutics Inc. and Lantern Pharma Australia Pty Ltd. All intercompany balances and transactions
have been eliminated in consolidation.

 Note
2. Liquidity

 The
Company incurred a net loss of approximately $ 20,781,000 and $ 15,962,000 during the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, the Company had working capital of approximately $ 20,916,000.

 The
Company plans to continue to explore periodic capital raises and also plans to apply for grant funding in the future to assist in supporting
its capital needs. We may also explore the possibility of entering into commercial credit facilities as an additional source of liquidity.
We believe that our existing cash, cash equivalents, and marketable securities as of December 31, 2024, and our anticipated expenditures
and capital commitments, will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from
the date of filing this Form 10-K for the year ended December 31, 2024.

 Note
3. Summary of Significant Accounting Policies

 Use
of Estimates and Assumptions

 The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. The significant areas of estimation include determining research
and development accruals, the inputs in determining the fair value of equity-based awards and warrants issued, the inputs in determining
present value of lease payments, and determining the fair value of marketable securities. Actual results could differ from those estimates.

 Foreign
Currency

 We
translate the financial statements of our Australian subsidiary, which has a functional currency of the Australian dollar, to U.S. dollars
using month-end exchange rates for assets and liabilities and average exchange rates for income and expenses. Translation gains and losses
are recorded in accumulated other comprehensive income (loss) as a component of stockholders' equity. Gains and losses resulting
from foreign currency transactions that are denominated in currencies other than our functional currency (U.S. dollar) are included within
other income, net on the consolidated statements of operations.

 Risks
and Uncertainties

 The
Company operates in an industry that is subject to intense competition, government regulation and rapid technological change. Operations
are subject to significant risk and uncertainties including financial, operational, technological, regulatory, and other risks, including
the potential risk of business failure.

 Our
marketable securities may be impacted by various risks related to interest rates, market conditions and credit risk. Our marketable securities
have had and may in the future have their market value fluctuate due to rises or falls in interest rates. While we believe our cash,
cash equivalents and marketable securities do not contain excessive risk, we cannot provide absolute assurance that in the future our
investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of cash and cash equivalents
at one or more financial institutions that are federally insured. Interest bearing and non-interest bearing accounts we hold at these
banking institutions are guaranteed by the Federal Deposit Insurance Corporation ("FDIC") up to $ 250,000 per depositor, per
FDIC-insured bank, per ownership category. Substantially all of our cash balances held at banking institutions at December 31, 2024 are
in excess of FDIC coverage.

 F- 9

and Development

and development costs are expensed as incurred. These expenses primarily consist of payroll, contractor expenses, research study expenses,
costs for manufacturing and supplies, clinical site costs and other costs for the conduct of clinical trials, costs for technical infrastructure
on the cloud for the purposes of developing the Company's RADR platform, and other costs for identifying, developing,
and testing drug candidates. Development costs incurred by third parties are expensed as the work is performed. Costs to acquire technologies,
including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.

 Cash
and Cash Equivalents

 The
Company considers money market funds and other highly liquid instruments with a short-term maturity of 3 months or less to be cash equivalents.
Cash equivalents at December 31, 2024 and 2023 were approximately $ 6,619,000 and $ 20,881,000, respectively, and are included along with
cash under the caption cash and cash equivalents on the Company's consolidated balance sheets.

 Prepaid
Expenses and Other Current Assets

 Prepaid
expenses and other current assets as of December 31, 2024 totaled approximately $ 1,235,000 and included approximately $ 820,000 of upfront
payments for contractor fees, academic research studies and services, and subscriptions, approximately $ 318,000 of prepaid annual insurance
fees, and approximately $ 97,000 of receivables from dividends and tax incentives.

 Prepaid
expenses and other current assets as of December 31, 2023 totaled approximately $ 2,039,000 and included approximately $ 746,000 of upfront
payments for contractor fees, academic research studies and services, and subscriptions, approximately $ 125,000 of intellectual property
related licensing and other fees, approximately $ 308,000 of prepaid annual insurance fees, and approximately $ 860,000 of receivables
from interest and tax incentives.

 F- 10

 Leases

 The
Company determines whether an arrangement contains a lease at inception. Operating leases are included in operating lease right-of-use
("ROU") assets, current portion of operating lease liabilities, and net of current portion of operating lease liabilities
on our consolidated balance sheets. Lease ROU assets represent the Company's right to use an underlying asset for the lease term
and lease liabilities represent an obligation to make lease payments arising from the lease. Lease ROU assets and lease liabilities are
recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company's
leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement
date in determining the present value of lease payments. The Company does not include options to extend or terminate the lease term unless
it is reasonably certain that the Company will exercise any such options. Rent expense is recognized under the operating leases on a
straight-line basis. The Company does not recognize right-of-use assets or lease liabilities for short-term leases, which have a lease
term of twelve months or less, and instead will recognize lease payments as expense on a straight-line basis over the lease term.

 Marketable
Securities

 The
Company's marketable securities consist of government and agency securities, corporate bonds, mutual funds, and common stock. We
classify our marketable securities as available-for-sale at the time of purchase and reevaluate such classification as of each balance
sheet date. We may sell these securities at any time for use in current operations even if they have not yet reached maturity. As a result,
we classify our investments, including securities with maturities beyond twelve months, as current assets in the accompanying consolidated
balance sheets.

 Available-for-sale
debt securities are recorded at fair value each reporting period. Unrealized gains and losses on available-for-sale debt securities are
excluded from earnings and recorded as a separate component within accumulated other comprehensive income (loss) on the consolidated
balance sheets until realized. Interest is reported within interest income on the consolidated statements of operations. We evaluate
our available-for-sale debt securities to assess whether the amortized cost basis is in excess of estimated fair value and determine
what amount of that difference, if any, is caused by expected credit losses. Allowance for credit losses are recognized as a charge in
other income, net on the consolidated statements of operations, and any remaining unrealized losses are included in accumulated other
comprehensive income (loss) on the consolidated balance sheets. The allowance for credit losses is zero at December 31, 2024 and 2023,
and there were no credit losses recorded for the years ended December 31, 2024 and 2023.

 Equity
securities, which are composed of mutual funds and common stock, are recorded at fair value each reporting period, with changes in fair
value of these investments, as well as dividends earned, recorded within other income, net on the consolidated statements of operations.

 We
determine realized gains and losses on the sale of marketable securities based on the specific identification method and record such
gains and losses within other income, net on the consolidated statements of operations.

 Income
Taxes

 Deferred
tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities
using enacted tax rates which will be in effect when the differences reverse. The Company provides a full valuation allowance against
net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax asset will be realized.

 Stock-based
Compensation

 Stock-based
awards have been accounted for as required by ASC 718 Compensation - Stock Compensation. Under ASC 718, awards are valued at fair
value on the date of grant, and that fair value is recognized over the requisite service period. Forfeitures are accounted for as they
occur.

 Recently
Adopted Accounting Pronouncement

 In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, requiring
public entities to disclose information about their reportable segments' significant expenses and other segment items on an interim
and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07,
as well as all existing segment disclosures and reconciliation requirements in ASC 280, on an interim and annual basis. The Company adopted
ASU 2023-07 during the year ended December 31, 2024. See Note 11 Segment Reporting for further details.

 New
Accounting Pronouncements Not Yet Adopted

 In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires
public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of
income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements
and related disclosures.

 In
November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive and Income - Expense Disaggregation Disclosures
(Subtopic 220-40), requiring public business entities to provide disaggregated disclosures of relevant income statement expenses.
The amendments aim to improve financial reporting by enhancing transparency in the notes to financial statements, specifically regarding
expense categories. The amendments in this update are effective for annual reporting periods beginning after December 15, 2026, and interim
reporting periods beginning after December 15, 2027. The Company is assessing the effect of this update on its consolidated financial
statements and related disclosures.

 F- 11

 Note
4: Commitments and Contingencies

 The
Company has entered into, and expects to enter into from time to time in the future, license agreements, strategic alliance agreements,
assignment agreements, research service agreements, and similar agreements related to the advancement of its product candidates and research
and development efforts. Significant agreements are described in detail below (collectively, the "License, Strategic Alliance,
and Research Agreements").

 Set
forth below are the approximate amounts expensed for License, Strategic Alliance, and Research Agreements during the years ended December
31, 2024 and 2023, respectively. These expensed amounts are included under research and development expenses in the accompanying consolidated
statements of operations.

of Research and Development

 Year Ended

 2024

 2023

 Amount Expensed for License, Strategic Alliance, and Research Agreements

 $
 6,882,000

 $
 5,993,000

 F- 12

 Set
forth below at December 31, 2024 and 2023, respectively, are (1) the approximate amounts accrued and payable under the License, Strategic
Alliance, and Research Agreements, and (2) the approximate amount of prepaid expenses and other current assets under the License, Strategic
Alliance, and Research Agreements. These amounts are included in the accompanying consolidated balance sheets at December 31, 2024 and
2023.

of Accounts Payable and Accrued Liabilities

 2024

 2023

 Amount accrued and payable under License, Strategic Alliance, and
 Research Agreements

 $
 1,725,000

 $
 1,563,000

 Prepaid expenses and other current assets under License, Strategic Alliance, and Research Agreements

 $
 490,000

 $
 511,000

 BioNumerik
Pharmaceuticals

 In
January 2018, the Company entered into an Assignment Agreement (the "Assignment Agreement") with BioNumerik Pharmaceuticals,
Inc. ("BioNumerik"), pursuant to which the Company acquired rights to domestic and international patents, trademarks and
related technology and data relating to LP-300 (Tavocept) for human therapeutic treatment indications. The Assignment Agreement replaced
a License Agreement that was entered into between the Company and BioNumerik in May 2016. The Company made upfront payments totaling
$ 25,000 in connection with entry into the Assignment Agreement.

 In
the event the Company develops and commercializes LP-300 internally, the Company is required to pay to the BioNumerik-related payment
recipients designated in the Assignment Agreement a percentage royalty in the low double digits on cumulative net revenue up to $100
million, with incremental increases in the percentage royalty for net cumulative revenue between $100 million and $250 million, $250
million and $500 million, and $500 million and $1 billion, with a percentage royalty payment that could exceed $200 million for net cumulative
revenue in excess of $1 billion. The Company has the right to first recover certain designated portions of patent costs and development
and regulatory costs before the payment of royalties described above.

 If
the Company enters into a third-party transaction for LP-300, the Company is required to pay the BioNumerik-related payment recipients
a specified percentage of any upfront, milestone, and royalty amounts received by the Company from the transaction, after first recovering
specified direct costs incurred by the Company for the development of LP-300 that are not otherwise reimbursed from such third-party
transaction.

 In
addition, the Assignment Agreement provides that the Company will use commercially diligent efforts to develop LP-300 and make specified
regulatory filings and pay specified development and regulatory costs related to LP-300. The Assignment Agreement also provides that
the Company will provide TriviumVet DAC ("TriviumVet") with (i) specified data and information generated by the Company with
respect to LP-300, and (ii) an exclusive license to use specified LP-300-related patent rights, trademark rights and related intellectual
property to support LP-300 development in non-human (animal) treatment indications.

 The
Company is also required to pay all patent costs on covered patents related to LP-300. These patent costs are included in general and
administrative expenses in the accompanying consolidated statements of operations. These patent costs are fully recoverable at the time
of any net revenue from LP-300, with up to 50% of net revenue amounts to be applied towards repayment of patent costs until such costs
are fully recovered.

 F- 13

 In
addition to the recovery of patent costs, the Company has the right to recover the $ 25,000 upfront payments made in connection with entry
into the Assignment Agreement, which payments are recoverable prior to making any royalty or third-party transaction sharing payments.
The Company also has the right to recover previously incurred LP-300 development and regulatory costs, with up to a mid-single digit
percentage of net revenue amounts to be applied towards repayment of development and regulatory costs until such costs are fully recovered.
No amounts were expensed with respect to BioNumerik during the years ended December 31, 2024 and 2023, respectively.

 AF
Chemicals

 In
January 2015, the Company entered into a Technology License Agreement to exclusively license domestic and international patent rights
from AF Chemicals, LLC ("AF Chemicals") for the treatment of cancer in humans for the compounds LP-100 (Irofulven) and LP-184.
In February 2016, the Company and AF Chemicals entered into an Addendum (the "Addendum") providing for additions and amendments
to the Technology License Agreement. In December 2020, the Company and AF Chemicals entered into a Second Addendum (the "Second
Addendum") providing for further additions and amendments to the Technology License Agreement. The Technology License Agreement,
Addendum and Second Addendum are collectively referred to as the "AFC License Agreement".

to the Second Addendum, the Company made specified payments to AF Chemicals during the twelve months ended December 31, 2024. The Second
Addendum also provides that, from December 30, 2020 until January 15, 2025, the Company will have no obligation to pay annual licensing
fees, development diligence extension payments, or patent maintenance fee payments to AFC under the AFC License Agreement.

 As
part of the Second Addendum, the Company has agreed to apply for specified orphan drug designations for LP-184 in the US and EU. The
Second Addendum also amends and clarifies other provisions of the Technology License Agreement, and provides the Company with the ability
to recover a portion of initial payments made under the Second Addendum from sublicense fees or royalty payments that may be made to
AFC by the Company or third parties prior to January 15, 2025.

to the AFC License Agreement the Company made annual licensing fee payments to AF Chemicals relating to LP-184 for periods prior to signing
the Second Addendum. In addition, the Company is obligated to make milestone payments to AF Chemicals at the time of an Investigational
New Drug Application ("IND") filing relating to LP-184 or LP-284 and also upon reaching additional specified milestones in
connection with the development and potential marketing approval of LP-184 or LP-284 in the United States, specified countries in Europe,
and other countries.

 The
AFC License Agreement also provides that the Company will pay AF Chemicals a royalty of at least a very small single digit percentage
of specified net sales of LP-184, LP-284 and other analogs. In addition, the AFC License Agreement contains specified time requirements
for the Company to file an IND, enroll patients in clinical trials, and file a potential NDA with respect to LP-184, with the ability
for the Company to pay AF Chemicals additional amounts ranging up to an amount in the low hundreds of thousands of dollars for each one,
two, three and four year extension to such development time requirements, with additional extensions beyond four years to be negotiated
by the Company and AF Chemicals.

to the Second Addendum, no additional payments of annual licensing fees or development diligence extension payments related to LP-184
or LP-284 were required to be made by the Company until January 15, 2025, at which time these obligations have resumed. The Company is
also obligated to make payments to AF Chemicals relating to LP-100 beginning January 15, 2025, as described below.

 In
the event of a sublicense of the LP-184 or LP-284 rights to a non-affiliated party, the Company is obligated to pay AF Chemicals (a) a low double-digit
percentage of the gross income and fees received by the Company with respect to the United States in connection with such
sublicense, and (b) a lower double digit percentage of the gross income and fees received by the Company with respect to Europe and
Japan in connection with such sublicense.

 F- 14

 The
amounts to be paid to AF Chemicals with respect to LP-100 under the AFC License Agreement are in many ways similar to the amounts to
be paid with respect to LP-184 as described above. In addition, the AFC License Agreement contains specified time requirements for the
Company to enroll patients in clinical trials and file a potential NDA with respect to LP-100. Extension fees may be paid by the Company
to AF Chemicals from time to time related to these requirements. Pursuant to the Second Addendum with AF Chemicals, no additional payments
of annual licensing fees or development diligence extension payments were required to be made by the Company with respect to LP-100 until
January 15, 2025, at which time these obligations have resumed. Approximately $ 125,000 and $ 175,000 were expensed with respect to the
AFC License Agreement during the years ended December 31, 2024 and 2023, respectively, which amounts are included in research and development
expenses in the accompanying consolidated statements of operations.

 Allarity
Therapeutics (formerly known as Oncology Venture)

 In
May 2015, the Company licensed various rights to LP-100 to Oncology Venture (now known as Allarity Therapeutics) pursuant to a Drug License
and Development Agreement. In February 2016, the Company and Allarity Therapeutics entered into an addendum and an amendment providing
for additions and amendments to the Drug License and Development Agreement. In connection with the Drug License and Development Agreement,
as amended (collectively, the "Allarity License and Development Agreement"), Allarity Therapeutics agreed to directly pay
to AF Chemicals on behalf of the Company certain amounts to satisfy the Company's milestone obligations to AF Chemicals with respect
to LP-100 under the AFC License Agreement. Amounts paid by Allarity Therapeutics to AF Chemicals on behalf of the Company would then
be deducted from amounts owed by Allarity Therapeutics to the Company.

 On
July 23, 2021, the Company entered into an Asset Purchase Agreement to reacquire global development and commercialization rights for
Irofulven (LP-100) from Allarity. The transaction includes global rights to LP-100, as well as the developed clinical protocol for an
intended study in bladder and prostate cancer patients who have a mutation in the ERCC2/3 genes. As a result of this transaction, the
Company has full authority to manage and guide future clinical development and commercialization of LP-100. Under the terms of the Asset
Purchase Agreement, the Company paid an initial upfront payment of $ 1,000,000 to Allarity, with an additional $ 1,000,000 held in escrow,
which were subsequently released to the Company, with the final release occurring in August 2023. The Company determined there was no
planned alternative future use for these assets outside of the clinical development of LP-100 and therefore the full amount of the upfront
payment was included in research and development expense. Allarity is also eligible to receive additional milestone payments over the
life of the program based on IP license milestones and regulatory filings and approvals in the US and EU, and low- to mid-single-digit
royalties on future commercial net sales.

 Fortrea
Inc.

 In
May 2023, the Company entered into initial agreements with Fortrea Inc. ("Fortrea") to begin serving as the lead
contract research organization (CRO) for the Company's Phase 2 clinical trial for LP-300 and the Company's Phase 1
clinical trial for LP-184. In July 2023, the Company entered into a clinical master services agreement and work orders with Fortrea
regarding additional CRO services to be provided by Fortrea relating to the LP-300 Phase 2 trial and the LP-184 Phase 1 trial. In
October 2023, the Company entered into a start-up work order with Fortrea regarding start-up assistance services to be provided by
Fortrea relating to the LP-284 Phase 1 trial, which start-up work order terminated in the first quarter of 2024. The Company and
Fortrea entered into a modification of the work order for the LP-184 Phase 1 trial effective December 2024, which modification
provided for the transition from Fortrea to the Company of all work conducted by Fortrea relating to the LP-184 Phase 1 trial. The
Company is currently discussing with Fortrea a potential amendment to make certain adjustments to the work order with Fortrea
relating to the LP-300 Phase 2 clinical trial. The Company expects to finalize and enter into the amendment to the LP-300 work order
in the second quarter of 2025. Approximately $ 5,487,000
and $ 2,096,000
was expensed with respect to the Fortrea agreements during the years ended December 31, 2024 and 2023, respectively, which amounts
are included in research and development expenses in the accompanying consolidated statements of operations. The Company expects to
make substantial payments to Fortrea over the next 12 to 18 months in connection with services provided by Fortrea as well as
clinical trial site and other pass-through costs relating to the LP-300 Phase 2 trial.

 Patheon
API Services

 The
Company has entered into agreements with Patheon API Services, Inc. ("Patheon") for the manufacture and supply of cGMP material
to support the Company's Phase 2 clinical trial for its product candidate LP-300. In addition to producing LP-300 API (active pharmaceutical
ingredient) under cGMP (current Good Manufacturing Practices) conditions, Patheon transferred previously validated manufacturing processes
and analytical methods for LP-300 and produced non-GMP material for use in support of non-clinical studies for LP-300. The agreements
provided for payments in stages as specified process and manufacturing milestones are achieved. Approximately $ 18,000 and $ 4,000 was expensed
with respect to the Patheon agreements during the years ended December 31, 2024 and 2023, respectively. These expenses were reduced by
approximately $ 30,000 and $ 35,000 during the years ended December 31, 2024 and 2023, respectively, due to a reduction in accrual estimates.
These amounts for the years ended December 31, 2023 and 2024 are included in research and development expenses in the accompanying consolidated
statements of operations. The Company expects to expense additional amounts in future periods in accordance with the progress of work
completed under the Patheon agreements.

 F- 15

 Piramal
Pharma Solutions

 In
January 2021, the Company entered into an agreement with Piramal Pharma Solutions ("Piramal") for the fill and finish manufacture
of LP-300 drug product at Piramal's Lexington, Kentucky site in support of future Phase 2 clinical testing. The agreement, as amended,
and additional agreements entered into with Piramal have provided for Piramal to conduct activities in support of the cGMP manufacturing
of LP-300, including analytical and process transfer activities, manufacture of cGMP clinical batches, and performance of stability studies
on cGMP batches of LP-300 drug product. Approximately $ 130,000 and $ 49,000 was expensed with respect to Piramal agreements during the
years ended December 31, 2024 and 2023, respectively, which amounts are included in research and development expenses in the accompanying
consolidated statements of operations. The Company expects to expense additional amounts in future periods with respect to Piramal relating
to stability studies and analytical support activities.

 vivoPharm

 In
September 2021, the Company's Australian subsidiary entered into an agreement with RDDT, a vivoPharm Company Pty Ltd ("vivoPharm"),
for multiple preclinical studies, including animal studies, as part of an IND-enabling program for LP-184. The Company's Australian
subsidiary entered into an additional agreement with vivoPharm in 2022 as part of an IND-enabling program for LP-284. Amendments to the
vivoPharm agreements were made in 2022 and 2023, and additional agreements were entered into with vivoPharm in 2023 and 2024 relating
to preclinical studies and related data analysis and support work. Approximately $ 56,000 and $ 1,012,000 was expensed with respect to
the vivoPharm agreements during the years ended December 31, 2024 and 2023, respectively, which amounts are included in research and
development expenses in the accompanying consolidated statements of operations.

 TD2

 In
October 2021, the Company entered into a Statement of Work, as amended in March 2022, with Translational Drug Development, LLC ("TD2")
providing for TD2 to serve as the lead contract research organization (CRO) for the Company's Phase 2 clinical trial for its product
candidate LP-300. No amounts were expensed during the year ended December 31, 2024 and approximately $ 420,000 was expensed with respect
to TD2 during the year ended December 31,2023, which amounts are included in research and development expenses in the accompanying consolidated
statements of operations. The Company's agreements with TD2 were terminated in 2023 in connection with the Company's engagement
of Fortrea to provide contract research organization services to the Company.

 Berkshire
Sterile Manufacturing

the years ended December 31, 2023 and 2024, the Company entered into agreements with Berkshire Sterile Manufacturing ("Berkshire")
to support technical transfer and GMP drug product manufacturing of LP-300. Approximately $ 141,000 and $ 334,000 were expensed with respect
to the Berkshire agreements during the years ended December 31, 2024 and 2023, respectively, which amounts are included in research and
development expenses in the accompanying consolidated statements of operations. The Company expects that additional amounts will be expensed
in future periods in accordance with the progress of work completed under the Berkshire agreements.

 F- 16

 Shilpa

 In
March 2022, the Company entered into an agreement with Shilpa Medicare Limited ("Shilpa") for fit-to-purpose process development
and synthesis of a key starting material relating to the synthesis of LP-184 under cGMP. In July 2022, the Company entered into agreements
with Shilpa Pharma Lifesciences for the cGMP synthesis of LP-184 API material as well as for drug product development and cGMP drug product
manufacturing of LP-184. In August 2022, the Company entered into agreements with Shilpa for the cGMP synthesis of LP-284 API material
as well as for drug product development and cGMP drug product manufacturing of LP-284. The Company entered into additional agreements
with Shilpa and its subsidiaries and affiliates in 2023 and in 2024 to support cGMP drug substance and drug product manufacturing and
stability studies for LP-184 and LP-284. Approximately $ 827,000 and $ 1,313,000 were expensed with respect to the Shilpa agreements during
the years ended December 31, 2024 and 2023, respectively, which amounts are included in research and development expenses in the accompanying
consolidated statements of operations. The Company expects that additional amounts will be expensed in future periods in accordance with
the progress of work completed under the Shilpa agreements.

 Curia

the years ended December 31, 2023 and 2024, the Company entered into agreements with Curia Global, Inc. ("Curia") relating
to the cGMP manufacture of LP-300 API and supporting activities. Approximately $ 82,000 and $ 414,000 were expensed with respect to the
Curia agreements during the years ended December 31, 2024 and 2023, respectively, which amounts are included in research and development
expenses in the accompanying consolidated statements of operations. The Company expects that additional amounts will be expensed in future
periods in accordance with the progress of work completed under the Curia agreements.

 LumaBridge
(formerly known as Cancer Insight)

 In
May 2022, the Company entered into an agreement with Cancer Insight, LLC, now known as LumaBridge, LLC ("LumaBridge") for
IND filing, regulatory support, Phase 1 pre-trial startup activities, and strategic program consulting relating to LP-184. No amounts
were expensed during the year ended December 31, 2024 and approximately $ 200,000 was expensed with respect to the LumaBridge agreements
during the year ended December 31, 2023 which amounts are included in research and development expenses in the accompanying consolidated
statements of operations.

 Other
Research and Service Provider Agreements

 In
addition to the agreements described above, the Company has entered into other research and service provider agreements for the advancement
of its product candidates and research and development efforts. The Company expects to expense additional amounts in future periods in
connection with existing and future research and service provider agreements.

 F- 17

 Actuate
Therapeutics

 In
May 2021, the Company entered into a Collaboration Agreement with Actuate Therapeutics, Inc. ("Actuate"), a clinical stage
private biopharmaceutical company focused on the development of compounds for use in the treatment of cancer, and inflammatory diseases
leading to fibrosis. Pursuant to the agreement, the Company and Actuate have collaborated on utilization of the Company's RADR
 platform to develop novel biomarker derived signatures for use with one of Actuate's product candidates. As part of the collaboration,
the Company received 25,000 restricted shares of Actuate stock, subject to meeting certain conditions of the collaboration, as well as
the potential to receive additional Actuate stock if results from the collaboration are utilized in future development efforts. In 2023,
the term of the Collaboration Agreement was extended until March 31, 2024. The Company is currently evaluating the possibility of further collaborations with Actuate. Certain affiliates of Bios Partners beneficially own greater than 10% of the Company's common stock
and also hold substantial beneficial ownership interests in Actuate. Through December 31, 2024, no revenues have been recognized under
the Agreement.

 The
restricted shares of Actuate stock had a nominal value when acquired and, therefore, were recorded at a cost of $ 0.
In August 2024, Actuate announced the closing of its initial public offering ("IPO"), which also included a reverse
stock split. Following the reverse stock split and the IPO, the Company holds 13,889
shares of common stock, which can be sold by the Company without restriction in accordance with Rule 144 of the Securities Act of
1933. At December 31, 2024, the Actuate common stock held by the Company had a fair value of approximately $ 111,000,
which was reported as an unrealized gain in other income, net on the Company's condensed consolidated statements of operations
for the year ended December 31, 2024.

 Note
5. Leases

 The
following provides balance sheet information related to leases as of December 31, 2024 and 2023:

of Balance Sheet Information Related to Leases

 2024

 2023

 Assets

 Operating
 lease, right-of-use asset, net

 $

 239,985

 $

 228,295

 Liabilities

 Current
 portion of operating lease liabilities

 $

 190,814

 $

 172,975

 Operating
 lease liabilities, net of current portion

 52,843

 61,496

 Total
 operating lease liabilities

 $

 243,657

 $

 234,471

 F- 18

 At
December 31, 2024, the future estimated minimum lease payments under non-cancelable operating leases are as follows:

 Schedule of Future Estimated Minimum Lease Payments Under Non-cancelable Operating Leases

 2025

 $
 205,315

 2026

 54,744

 Total minimum lease payments

 260,059

 Less amount representing interest

 ( 16,402
)

 Present value of future minimum lease payments

 243,657

 Less current portion of operating lease liabilities

 ( 190,814
)

 Operating lease liabilities, net of current portion

 $
 52,843

 The
Company leases office space in the Dallas, Texas and Atlanta, Georgia metropolitan areas under non-cancellable operating leases. In January
2023, the Company renewed its existing lease in the Atlanta area for an additional two years ("Colony Square Lease"). Effective
August 31, 2024, the Colony Square Lease was terminated in conjunction with a new lease with the same landlord. The new lease began September
1, 2024 for a period of 24 months, requires payments of approximately $ 6,800 per month, and is subject to automatic renewal on a month-to-month
basis unless the Company provides three-months written notice to the landlord. The exercise of lease renewal options is at the Company's
sole discretion and is assessed as to whether to include any renewals in the lease term at inception.

 In
January 2023, the Company also entered into two new leases in Dallas that commenced in March 2023 and May 2023, respectively ("Legacy
West Leases"). Effective April 30, 2024, the Legacy West Leases were terminated in conjunction with a new lease with the same landlord.
The new lease began May 1, 2024 for a period of 19 months, requires payments of approximately $ 11,200 per month, and is subject to automatic
renewal on a month-to-month basis unless the Company provides three-months written notice to the landlord. The exercise of lease renewal
options is at the Company's sole discretion and is assessed as to whether to include any renewals in the lease term at inception.

 The
following table provides a reconciliation for the Company's right of use assets and lease liabilities:

 Schedule of Reconciliation of Right-of-Use Assets and lease Liabilities

 Right-of-Use Asset

 Operating Lease Liability

 Balance at January 1, 2023

 $
 47,687

 $
 52,890

 Remeasurement of operating lease right-of-use assets and operating lease liability

 198,847

 198,847

 Operating right-of-use asset acquired through operating lease liability

 141,989

 141,989

 Amortizations

 ( 160,228
)

 ( 159,255
)

 Balance at December 31, 2023

 228,295

 234,471

 Early termination of operating leases

 ( 163,722
)

 ( 163,722
)

 Operating right-of-use asset acquired through operating lease liability

 348,623

 348,623

 Amortizations

 ( 173,211
)

 ( 175,715
)

 Balance at December 31, 2024

 $
 239,985

 $
 243,657

 Other
supplemental information related to operating leases is as follows:

 Schedule of Other Supplemental Information Related to Operating Leases

 As of

 2024

 2023

 Weighted average remaining term of operating leases (in years)

 1.30

 1.33

 Weighted average discount rate of operating leases

 9.50
 %

 7.36
 %

 The
Company also leased office space in Dallas, Texas under month-to-month lease arrangements during the years ended December 31, 2024 and
2023. In April 2023, the Company entered into a two -year lease for material storage and handling. The lease is cancellable with 45-days'
written notice. Under these short-term leases, the Company elected the short-term lease measurement and recognition exemption under ASC
842 and recorded rent expense as incurred.

 The
components of lease expense were approximately as follows for the years ended December 31, 2024 and 2023:

 Schedule of Lease Expense

 2024

 2023

 Operating lease cost

 $
 191,000

 $
 178,000

 Short-term lease cost

 19,000

 14,000

 Lease expense

 $
 210,000

 $
 192,000

the years ended December 31, 2024 and 2023, cash used in operating activities associated with these leases was approximately $ 194,000
and $ 177,000, respectively.

 Note
6. Shareholders' Equity

 Preferred
Stock

 Upon
the Company's IPO, all shares of the Company's Series A preferred stock were converted into 2,438,851 shares of common stock
effective June 15, 2020, with fractional share adjustments made in connection with the conversion as discussed below. As of December
31, 2024 and 2023, the Company had 1,000,000 authorized shares of preferred stock, with zero shares of preferred stock issued and outstanding.

 F- 19

 Common
Stock

the year ended December 31, 2023, the Company repurchased 145,348 shares of its common stock for an aggregate purchase price of approximately
$ 500,000. Upon purchase, the repurchased shares ceased to be outstanding and returned to the status of authorized and unissued shares
of common stock.

the year ended December 31, 2023, the Company issued 12,000 shares of restricted common stock to consultants with a grant date fair value
of approximately $ 63,000. 9,500 shares of restricted stock vested during 2023, and the remaining 2,500 were forfeited. The Company reported
approximately $ 50,000 of stock-based compensation related to the vested restricted common stock during the year ended December 31, 2023,
which is included in general and administrative expenses in the accompanying consolidated statements of operations. With the vesting
of the 9,500 shares of restricted stock as described above, no shares of restricted common stock were outstanding at December 31, 2023.

the year ended December 31, 2024, the Company issued 20,000 shares of restricted common stock to a consultant with a grant date fair
value of approximately $ 81,000, which was included as stock-based compensation as part of general and administrative expenses in the
accompanying consolidated statements of operations when the shares vested on October 4, 2024. No shares of restricted common stock were
outstanding at December 31, 2024.

 As
of December 31, 2024 and December 31, 2023, the Company had 25,000,000 authorized shares of Common Stock, of which 10,784,725 and 10,721,192
shares were issued and outstanding, respectively.

 Warrants

 The
Company had warrants to purchase 177,998 shares of common stock outstanding and exercisable as of December 31, 2023 at a weighted average
exercise price of $ 9.27 per share, and with expiration dates ranging from March 7, 2024 to June 10, 2025.

the year ended December 31, 2024, the Company issued 21,313 shares of common stock for aggregate proceeds of $ 66,710, relating to the
exercise of warrants that were expiring. The Company also issued 22,220 shares of common stock relating to the cashless exercise of warrants
to purchase 86,685 shares during the year ended December 31, 2024. The Company had warrants to purchase 70,000 shares of common stock
outstanding and exercisable as of December 31, 2024 at a weighted average exercise price of $ 18.75 per share, which warrants expire on
 June 10, 2025.

 Options

 On
August 29, 2018, the Board of Directors of the Company adopted the Lantern Pharma Inc. 2018 Equity Incentive Plan, which was subsequently
amended on December 17, 2018, February 26, 2020, October 20, 2022, June 16, 2023 and June 13, 2024. The Lantern Pharma Inc. 2018 Equity
Incentive Plan, as amended and restated, is referred to herein as the "Plan". The Company has reserved 1,864,680 shares of
its common stock for issuance under the Plan. The Plan is designed to provide additional incentives to employees, directors and consultants
to remain in the service of the Company as well as to encourage stock acquisition by members of these targeted groups, which in the opinion
of the management will support the alignment of the interests of the members of these groups and stockholders. Options granted under
the Plan are generally exercisable for up to 10 years from grant date. 423,693 shares remain available for future awards under the Plan
at December 31, 2024, following the grant of options and the award of restricted stock grants through December 31, 2024.

 F- 20

 A
summary of stock option activity under the Plan during the years ended December 31, 2024 and 2023 is presented below:

of Stock Option Activity

 Options Outstanding

 Options Exercisable

 Number of
 Shares

 Weighted-Average
 Exercise Price

 Number of
 Options

 Weighted-Average
 Exercise Price

 Outstanding December 31, 2022

 1,037,591

 $
 6.46

 755,073

 $
 5.87

 Granted

 126,000

 4.43

 Cancelled or expired

 ( 72,395
)

 8.20

 Outstanding December 31, 2023

 1,091,196

 6.11

 880,241

 6.25

 Granted

 259,000

 4.56

 Cancelled or expired

 ( 104,502
)

 6.90

 Outstanding December 31, 2024

 1,245,694

 $
 5.72

 971,472

 $
 6.07

 The
weighted average remaining contractual term of outstanding options at December 31, 2024 is 6.14 years. The weighted average remaining
contractual term of exercisable options at December 31, 2024 is 5.27 years. The total intrinsic value of options outstanding at December
31, 2024 and 2023 was approximately $ 1,014,000 and $ 1,552,000, respectively. The total intrinsic value of options exercisable at December
31, 2024 and 2023, was approximately $ 1,014,000 and $ 1,526,000, respectively.

 Approximate
stock-based compensation relating to options was as follows for the years ended December 31, 2024 and 2023:

of Stock-based Compensation

 2024

 2023

 General and administrative

 $
 291,000

 $
 566,000

 Research and development

 361,000

 451,000

 $
 652,000

 $
 1,017,000

 Total
remaining unrecognized compensation expense for non-vested options is approximately $ 908,000 as of December 31, 2024, and is expected
to be recognized over a weighted average period of 1.54 years.

 For
the years ended December 31, 2024 and 2023, the fair value of each option granted was estimated using the Black-Scholes option-pricing
model, using the following weighted average assumptions:

of Weighted Average Assumptions

 2024

 2023

 Term (in years)

 5.58

 5.73

 Risk Free Rate

 4.15
 %

 4.01
 %

 Volatility

 88.35
 %

 86.91
 %

 Dividend Yield

 0.00
 %

 0.00
 %

 Grant Date Fair Value

 $
 3.36

 $
 3.25

 The
fair value of options is recognized as an expense over the vesting period and forfeitures are accounted for as they occur.

 Expected
 Term -

 The
 Company used a weighted average of time to vesting and maturity date.

 Expected
 Volatility-

 Due
 to the Company's limited operating history and a lack of company-specific historical and implied volatility data, the Company
 has in part based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly
 traded commensurate with expected term as of grant date. The historical volatility data was computed using the daily closing prices
 for the selected comparable companies' shares.

 Risk-Free
 Interest Rate-

 The
 Company used the U.S. treasury bill rate commensurate with the expected term as of grant date.

 Expected
 Dividend-

 As
 the Company has not issued any dividends and does not expect to issue dividends over the life of the options, the Company has estimated
 the dividend yield to be zero.

 F- 21

 Note
7. Securities

 At
December 31, 2024, the Company's debt and equity securities, including approximately $ 2,542,000 classified in cash and cash equivalents,
consisted of the following:

 Schedule of Marketable of Securities

 Amortized
 Cost

 Gains

 Losses

 Aggregate
 Fair Value

 $
 11,461,885

 $
 3,270

 $
 ( 1,670
)

 $
 11,463,485

 1,845,226

 ( 944
)

 1,845,235

 Debt securities

 $
 13,307,111

 $
 4,223

 $
 ( 2,614
)

 13,308,720

 Equity securities

 6,429,576

 $
 19,738,296

 Included in cash and cash equivalents

 $
 3,236,312

 Included in marketable securities

 $
 16,501,984

 At
December 31, 2023, the Company's debt and equity securities consisted of the following:

 Amortized
 Cost

 Gains

 Losses

 Aggregate
 Fair Value

 $
 5,576,819

 $
 3,969

 $
 ( 66,680
)

 $
 5,514,108

 8,322,723

 ( 44,872
)

 8,278,365

 Debt securities

 $
 13,899,542

 $
 4,483

 $
 ( 111,552
)

 13,792,473

 Equity securities

 15,825,016

 $
 29,617,489

 Included in cash and cash equivalents

 $
 10,252,566

 Included in marketable securities

 $
 19,364,923

 The
contractual maturities of the Company's debt securities, including approximately $ 2,542,000 classified in cash and cash equivalents,
are as follows:

 Schedule of Contractual Maturities Investments of Marketable Securities

 As of
 December 31, 2024

 Due within one year

 $
 13,308,720

 F- 22

 The
following table presents gross unrealized losses and fair values for those marketable debt securities that were in an unrealized loss
position as of December 31, 2024, aggregated by investment category and the length of time that individual debt securities have been
in a continuous loss position:

 Schedule of Gross Unrealized Losses and Fair Values for Marketable Securities

 As of
December 31, 2024

 Less than 12 months

 More than 12 months

 Fair
 Value

 Loss

 Fair
 Value

 Loss

 $
 1,284,465

 $
 ( 64
)

 $
 797,324

 $
 ( 1,606
)

 -

 -

 297,687

 ( 944
)

 $
 1,284,465

 $
 ( 64
)

 $
 1,095,011

 $
 ( 2,550
)

 We
do not believe the unrealized losses on debt securities represent credit losses based on our evaluation of available evidence as of December
31, 2024, which includes an assessment of whether it is more likely than not we will be required to sell the investment before recovery
of the investment's amortized cost basis.

 Note
8. Fair Value Measurements

 We
determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use
of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would
be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement
date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous
market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions
that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the
hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes
the inputs into three levels that may be used to measure fair value:

 Level
1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.

 Level
2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability,
either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.

 Level
3 - Inputs are unobservable inputs based on our assumptions.

 Financial
Assets

 When
available, our marketable securities are valued using quoted prices for identical instruments in active markets. If we are unable to
value our marketable securities using quoted prices for identical instruments in active markets, we value our investments using broker
reports that utilize quoted market prices for comparable instruments. As of December 31, 2024 and 2023 our available-for-sale debt securities
were valued through use of quoted prices for comparable instruments in active markets and are classified as Level 2, and our money market
accounts, common stock and mutual funds were valued using quoted prices in active markets for identical assets and are classified as
Level 1.

 Based
on our valuation of our marketable securities, we concluded that they are classified in either Level 1 or Level 2, and we have no financial
assets measured using Level 3 inputs. The following table presents information about our assets that are measured at fair value on a
recurring basis using the above input categories.

 F- 23

of Assets are Measured at Fair Value on Recurring Basis

 Fair Value Measurements as of
 December 31, 2024

 Description

 Total

 Level 1

 Level 2

 Level 3

 $
 11,463,485

 $
 -

 $
 11,463,485

 $
 -

 1,845,235

 -

 1,845,235

 -

 Money markets

 694,420

 694,420

 -

 -

 Mutual funds – fixed income

 3,777,950

 3,777,950

 -

 -

 Mutual funds – alternative investments

 1,846,650

 1,846,650

 -

 -

 Common stock

 110,556

 110,556

 -

 -

 Fair
 value recurring basis

 $
 19,738,296

 $
 6,429,576

 $
 13,308,720

 $
 -

 Included in cash and cash equivalents

 $
 3,236,312

 Included in marketable securities

 $
 16,501,984

 Fair Value Measurements as of
 December 31, 2023

 Description

 Total

 Level 1

 Level 2

 Level 3

 $
 5,514,108

 $
 -

 $
 5,514,108

 $
 -

 8,278,365

 -

 8,278,365

 -

 Money markets

 10,252,566

 10,252,566

 -

 -

 Mutual funds – fixed income

 3,733,600

 3,733,600

 -

 -

 Mutual funds – alternative investments

 1,838,850

 1,838,850

 -

 -

 Fair
 value recurring basis

 $
 29,617,489

 $
 15,825,016

 $
 13,792,473

 $
 -

 Included in cash and cash equivalents

 $
 10,252,566

 Included in marketable securities

 $
 19,364,923

 Note
9. Loss Per Share of Common Shares

 Basic
loss per share is derived by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock
outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities,
such as warrants and stock options, which would result in the issuance of incremental shares of common stock unless such effect is anti-dilutive.
In calculating the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remained
the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation. Potentially
dilutive securities outstanding that have been excluded from diluted loss per share due to being anti-dilutive include the following:

of Anti-dilutive Securities Outstanding Diluted Loss Per Share

 For the year ended

 2024

 2023

 Warrants

 70,000

 177,998

 Stock options

 1,245,694

 1,091,196

 Anti-dilutive
 securities

 1,315,694

 1,269,194

 F- 24

 Note
10. Income Taxes

 Our
effective tax rate differs from the statutory federal tax rate as presented in the following table:

of Effective Income Tax Rate

 2024

 2023

 U.S. federal statutory tax rate

 %

 %

 Permanent differences

 %

 -
 %

 Valuation allowance

 ( 25
)%

 ( 21
)%

 Total:

 -
 %

 -
 %

 As
of December 31, 2024 and 2023, the Company was domiciled in Texas, and due to the losses generated and no revenues, it incurred no current
federal or state tax.

 The
tax effect of the temporary differences that give rise to the significant portions of the deferred tax assets and liabilities is presented
below.

of Deferred Tax Assets and Liabilities

 2024

 2023

 Deferred tax assets

 Research and development credits

 $
 2,222,625

 $
 1,436,914

 584,840

 538,771

 Net operating loss carryforwards

 9,353,936

 7,383,777

 Unrealized losses on securities

 -

 22,624

 Research and development amortization

 5,617,727

 3,164,305

 Deferred tax asset

 17,779,128

 12,546,391

 Less: valuation allowance

 ( 17,772,997
)

 ( 12,542,542
)

 Net deferred tax asset

 6,131

 3,849

 Deferred tax liabilities

 Unrealized gains on securities

 ( 1,837
)

 -

 Operating lease right-of-use assets

 ( 776
)

 -

 Fixed assets

 ( 3,518
)

 ( 3,849
)

 Net deferred tax assets

 $
 -

 $
 -

 Due
to a history of losses the Company has generated since inception, the Company believes it is more-likely-than-not that all of the deferred
tax assets will not be realized as of December 31, 2024 and 2023. Therefore, the Company has recorded a full valuation allowance on its
deferred tax assets. At December 31, 2024 and 2023, the Company has net operating loss ("NOL") carryforwards for federal
income tax purposes of approximately $ 43,600,000 and $ 34,500,000, respectively. The NOL carryforwards generated prior to 2018 of approximately
$3,100,000 could expire over time beginning in 2035, if not used. The NOL carryforwards generated from January 1, 2018 through December
31, 2024 of approximately $40,500,000 do not expire and are carried forward indefinitely. The Company has state NOLs of approximately
$ 1,000,000 at December 31, 2024. Australian NOLs were approximately $ 500,000 at December 31, 2024 and can be carried forward indefinitely,
but may be subject to limitation in the event of certain corporate stock transactions the Company may enter into in the future. The Company
also has approximately $ 2,200,000 of research and development tax credit carryforwards for federal purposes. These credits begin expiring
in 2039. Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company's NOL carryforwards
and research and development credit carryforwards may be subject to annual limitations under Section 382 of the Internal Revenue Code
against taxable income in the future period, which could substantially limit the eventual utilization of such carryforwards.

 Entities
are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns.
The Company has analyzed its tax positions and has concluded that as of December 31, 2024, there were no uncertain positions. In addition,
interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision, for which there were
none. The Company's U.S. federal operating losses have occurred since its inception and as such, tax years subject to potential
tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to
audit by the IRS and/or state taxing authorities. The statute of limitations expires three years after the utilization of historical
losses.

 The
Tax Cuts and Jobs Act of 2017 (TCJA) has modified the IRC 174 expenses related to research and development for the tax years beginning
after December 31, 2021. Under the TCJA, the Company must now capitalize the expenditures related to research and development activities
and amortize over five years for U.S. activities and 15 years for non-U.S. activities using a mid-year convention. Therefore, the capitalization
of research and development costs in accordance with IRC 174 resulted in a net deferred tax asset of $ 5,617,727 as of December 31,
2024.

 Note
11: Segment Reporting

 The
Company operates as one operating segment. The Company's chief operating decision maker ("CODM") is its chief executive
officer, who reviews financial information presented on a consolidated basis. The CODM uses expected research and development study and
material costs; cash, cash equivalents and marketable securities balances; operating losses; and budget projections to assess financial performance and allocate resources. During
the years ended December 31, 2024 and 2023, research and development study and material costs, which include clinical trial and product
candidate manufacturing costs, were approximately $ 11,400,000 and $ 8,453,000, respectively. These financial metrics are used by the CODM
to make key operating decisions, such as which research and development studies to commence, extend or discontinue. See the consolidated
balance sheets and statements of operations as of and for the years ended December 31, 2024 and 2023.

 F- 25

 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.

 Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal
financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024. The
term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information
required to be disclosed by a company in the reports that it files or submits 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 by a company in the reports that it
files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive
and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that
any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives
and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 Based
on such evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive Officer and Chief Financial
Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

 Management's
Annual Report on Internal Control Over Financial Reporting.

 Our
management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed under the supervision of our
principal executive officer and principal financial officer to provide reasonable assurance regarding the reliability of our financial
reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
Management assessed our internal control over financial reporting as of December 31, 2024. Management based its assessment on criteria
established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission
(2013 Framework). Based on that evaluation, our management concluded that our internal control over financial reporting was effective
as of December 31, 2024.

 This
Annual Report does not include an attestation report of our independent registered public accounting firm due to an exemption established
by the JOBS Act for "emerging growth companies".

 Changes
in Internal Control Over Financial Reporting.

 There
were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during the three-month period ended December 31, 2024 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.

 Inherent
Limitations on Effectiveness of Controls.

 Our
management, including our principal executive officer and principal financial officer, do not expect that our disclosure controls or
our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are 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. These inherent limitations include the realities that judgments
in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented
by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any
system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance
that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate
because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations
in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 Item
9B. Other Information.

the quarter ended December 31, 2024, no director or officer adopted or terminated (i) any contract, instruction or written plan for the
purchase or sale of securities of the Company intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or (ii) any "non-Rule
10b5-1 trading arrangement" as defined in paragraph (c) of item 408 of Regulation S-K.

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

 Not
Applicable

 PART
III

 Item
10. Directors, Executive Officers and Corporate Governance.

 The
information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement
related to our annual meeting of stockholders to be held in 2025 (the "2025 Annual Meeting of Stockholders"), which we intend
to file with the SEC within 120 days of the year ended December 31, 2024.

 Item
11. Executive Compensation.

 The
information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement
related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31,
2024.

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

 The
information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement
related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31,
2024.

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

 The
information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement
related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31,
2024.

 Item
14. Principal Accountant Fees and Services.

 The
information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement
related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31,
2024.

 PART
IV

 Item
15. Exhibit and Financial Statement Schedules.

 (a)
The following documents are filed as part of this report:

 (1)

 Financial
 Statements

 Report of Independent Registered Public Accounting Firm (PCAOB ID No. 274)

 Consolidated Balance Sheets – December 31, 2024 and 2023

 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Stockholders' Equity (Deficit) for the Years Ended December 31, 2024 and 2023

 Consolidated Statements of Cash Flow for the Years Ended December 31, 2024 and 2023

 Notes to Consolidated Financial Statements

 (2)

 Financial
 Statement Schedules

 All
financial statement schedules are omitted because the information called for is not required or is shown either in the consolidated financial
statements or in the notes thereto.

 (3)

 Exhibits

 The
following exhibits are filed herewith or incorporated by reference herein:

 Exhibit
 No.

 Description

 3.1

 (a)

 Certificate of Conversion (Texas)

 3.2

 (a)

 Certificate of Conversion (Delaware)

 3.3

 (a)

 Certificate of Incorporation

 3.4

 (b)

 Certificate of Amendment to Certificate of Incorporation

 3.5

 (b)

 Amended and Restated Certificate of Incorporation

 3.1.(vi)

 (a)

 By-laws

 4.1

 (a)

 Form of Warrant (2019)

 4.2

 (c)

 Form of Amendment to Series A Preferred Stock Warrant

 4.3

 (i)

 Form of Underwriters' Warrant (2020)

 4.4

 (d)

 Specimen Stock Certificate evidencing shares of common stock

 4.5

 (k)

 Description of Capital Stock

 10.1

 (l)

 Second Amended and Restated 2018 Equity Incentive Plan dated October 20, 2022

 10.2

 (m)

 Amendment to Second Amended and Restated Lantern Pharma Inc. 2018 Equity Incentive Plan

 10.3+

 (a)

 Employment Agreement dated July 23, 2018 with Panna Sharma

 10.4+

 (f)

 Amendment to Employment Agreement dated May 18, 2020 with Panna Sharma

 10.5+

 (c)

 Employment Agreement dated May 18, 2020 with David Margrave

 10.6

 (o)

 Amendment to Employment Agreement with Kishor Bhatia dated December 28, 2023

 10.7

 (o)

 Amendment to Employment Agreement with David Margrave dated December 28, 2023

 10.8+

 (a)

 Form of Indemnification Agreement

 10.9

 (a)

 Amended and Restated Investors' Rights Agreement

 10.10#

 (a)

 Technology License Agreement dated January 15, 2015, with AF Chemicals, LLC

 10.11#

 (a)

 Assignment Agreement dated as of January 5, 2018 with BioNumerik Pharmaceuticals, Inc.

 10.12#

 (a)

 Addendum to Technology License Agreement dated February 8, 2016, with AF Chemicals, LLC

 10.13+

 (c)

 Employment Agreement dated May 18, 2020 with Kishor G Bhatia

 10.14

 (g)

 API Services Project Agreement dated July 10, 2020 with Patheon API Service

 10.15#

 (h)

 Second Addendum to Technology License Agreement dated December 30, 2020 with AF Chemicals, LLC

 10.16

 (n)

 Additional Amendment to Second Amended and Restated Lantern Pharma Inc. 2018 Equity Incentive Plan

 10.17*

 Amendment to Employment Agreement with Kishor Bhatia dated January 1, 2025

 19.1*

 Lantern Pharma Inc. Insider Trading Policy

 21.1

 (l)

 List of Subsidiaries

 23.1*

 Consent of EisnerAmper LLP, independent registered public accounting firm

 31.1*

 Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-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 Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 32.1**

 Certifications of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 97.1

 (o) Lantern Pharma Inc. Executive Officer Clawback Policy

 101.INS*

 101.SCH*

 101.CAL*

 101.DEF*

 101.LAB*

 101.PRE*

 104*

 Cover

 (a)

 by reference from the Registration Statement on Form S-1 filed April 16, 2020.

 (b)

 by reference from Current Report on Form 8-K filed June 17, 2020.

 (c)

 by reference from the Registration Statement on Form S-1/A filed May 19, 2020.

 (d)

 by reference from the Registration Statement on Form S-1/A filed May 12, 2020.

 (e)

 by reference from Current Report on Form 8-K filed August 21, 2020.

 (f)

 by reference from the Registration Statement on Form S-1/A filed June 8, 2020.

 (g)

 by reference from Quarterly Report on Form 10-Q for the period ending September 30, 2020.

 (h)

 by reference from the Registration Statement on Form S-1 filed January 8, 2021.

 (i)

 by reference from Exhibit 1.1 of the Registration Statement on Form S-1/A filed May 19, 2020.

 (j)

 by reference from Exhibit 10.17 of Annual Report on Form 10-K filed March 10, 2021.

 (k)

 by reference from Exhibit 4.3 of Annual Report on Form 10-K filed March 10, 2021.

 (l)

 by reference from Annual Report on Form 10-K filed March 20, 2023.

 (m)

 by reference from Exhibit A to Registrant's Definitive Proxy Statement filed April 28, 2023.

 (n)

 Incorporated by reference from Exhibit A to Registrant's Definitive
Proxy Statement filed April 29, 2024.

 (o)

 Incorporated by reference from Annual Report on Form 10-K filed March 18,
2024.

 +

 Indicates
 a management control or any compensatory plan, contract or arrangement.

 #

 Certain
 confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark) because the identified
 confidential portions (i) are not material and (ii) are of the type that the Registrant treats as private and confidential.

 *

 Filed
 herewith.

 **

 Furnished
 with this report

 Item
16. Form 10–K Summary.

 Not
applicable.

 SIGNATURES

to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.

 Pharma Inc.,

 A
 Delaware Corporation

 Dated:
 March 27, 2025

 By:

 /s/
 Panna Sharma

 Panna
 Sharma, Chief Executive Officer

 Dated:
 March 27, 2025

 By:

 /s/
 David R. Margrave

 David
 R. Margrave, Chief Financial Officer

to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.

 Name

 Title

 Date

 /s/
 Panna Sharma

 President,
 Chief Executive Officer and Director

 March

 Panna
 Sharma

 (Principal
 Executive Officer)

 /s/
 David R. Margrave

 Chief
 Financial Officer

 March

 David
 R. Margrave

 ( Principal
 Financial and Principal Accounting Officer)

 /s/
 Donald J. Keyser

 Chairman
 of the Board

 Donald
 J. Keyser

 March

 /s/
 Maria Maccecchini

 Director

 Maria
 Maccecchini

 March

 /s/
 David S. Silberstein

 Director

 David
 S. Silberstein

 March

 /s/
 Vijay Chandru

 Director

 Vijay
 Chandru

 March