UNITED STATES

 SECURITIES AND EXCHANGE COMMISSION

 Washington, D.C. 20549

 FORM 10-K

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

 For the fiscal year ended December 31, 2024

 OR

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

 For the transition period from ___ to ___

 Commission file number 001-41596

 (Exact name of registrant as specified in its charter)

 Delaware

 88-0860746

 (State or other jurisdiction of

incorporation or organization)

 (I.R.S. Employer

Identification No.)

 822 A1A North, Suite 306

 Ponte Vedra, Florida 32082

 32082

 (Address of principal executive offices)

 (Zip Code)

 Registrant's telephone number, including
area code: (904) 300-0701

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

 Title of each class

 Trading Symbol(s)

 Name of each exchange on which registered

 Common Stock, par value $0.001 per share

 CVKD

 The Nasdaq Stock Market, LLC

 (The Nasdaq Capital Market)

 Securities registered pursuant to Section 12(g)
of the Act: None

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

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

(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days.

 Yes No

has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

 Yes No

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

 Large accelerated filer

 Accelerated filer

 Non-accelerated filer

 Smaller reporting company

 Emerging growth company

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

has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 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.

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

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

 The aggregate market value of the voting and non-voting
common equity held by non-affiliates of the registrant, based on the closing price of a share of the registrant's common stock on
June 30, 2024, as reported by the Nasdaq Capital Market on such date was approximately $ 4,008,255. Shares of the registrant's common
stock held by each executive officer, director and holder of 5% or more of the outstanding common stock have been excluded in that such
persons may be deemed to be affiliates. This calculation does not reflect a determination that certain persons are affiliates of the registrant
for any other purpose.

 As of March 13, 2025, there were 1,879,710 shares of Common Stock, $0.001
par value per share, outstanding.

 DOCUMENTS INCORPORATED BY REFERENCE: None

 Page

 Item 1.

 Business

 Item 1A.

 Risk Factors

 Item 1B.

 Unresolved Staff Comments

 Item 1C.

 Cybersecurity

 Item 2.

 Properties

 Item 3.

 Legal Proceedings

 Item 4.

 Mine Safety Disclosures

 Item 5.

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

 Item 6.

 [Reserved]

 Item 7.

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

 Item 7A.

 Quantitative and Qualitative Disclosures About Market Risk

 Item 8.

 Financial Statements and Supplementary Data

 Item 9.

 Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

 Item 9A.

 Controls and Procedures

 Item 9B.

 Other Information

 Item 9C.

 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

 Item 10.

 Directors, Executive Officers and Corporate Governance

 Item 11.

 Executive Compensation

 Item 12.

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

 Item 13.

 Certain Relationships and Related Transactions, and Director Independence

 Item 14.

 Principal Accountant Fees and Services

 Item 15.

 Exhibits and Financial Statement Schedules

 Item 16.

 Form 10-K Summary

 i

 Forward-Looking Statements

 This Annual Report on Form 10-K (this
"Annual Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I,
Item 1. "Business," Part I, Item 1A. "Risk Factors," and Part II, Item 7. "Management's
Discussion and Analysis of Financial Condition and Results of Operations," but are also contained elsewhere in this Annual Report
in some cases you can identify forward-looking statements by terminology such as "may," "should," "potential,"
"continue," "expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are based on our current beliefs, expectations, and assumptions and
are subject to a number of risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could
cause actual results to differ materially from those expressed, projected or implied in or by the forward-looking statements.

 You should refer to Part I, Item 1A.
"Risk Factors" section of this Annual Report for a discussion of important factors that may cause our actual results to differ
materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that
the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove
to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you
should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and
plans in any specified time frame, or at all. We do not undertake any obligation to update any forward-looking statements. Unless the
context requires otherwise, references to "we," "us," "our," and "Cadrenal," refer to
Cadrenal Therapeutics, Inc.

 This Annual Report also contains market data
related to our business and industry. These market data include projections that are based on a number of assumptions. If these assumptions
turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not
grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may harm on our business,
results of operations, financial condition and the market price of our common stock, par value $0.001 per share (the "Common Stock").

 Note Regarding Company References

 Throughout this Annual Report, "Cadrenal,"
"the Company," "we" and "our" refer to Cadrenal Therapeutics, Inc.

 Summary Risk Factors

 Our business faces significant risks and uncertainties of which investors
should be aware before making a decision to invest in our Common Stock. If any of the following risks are realized, our business, financial
condition and results of operations could be materially and adversely affected. The following is a summary of the more significant risks
relating to the Company. A more detailed description of our risk factors is set forth below under the caption "Risk Factors"
in Item 1A in Part I of this Annual Report.

 Risks Related to Our Financial Position
and Need for Capital

 We have a limited operating history, a history of losses and expect to continue to incur losses;

 Our cash and the proceeds from our financings will only fund our operations
for a limited time; and

 We will need to raise additional capital.

 Risks Related to Product Development, Regulatory
Approval, Manufacturing and Commercialization

 Our
business is dependent upon the success of tecarfarin, which requires additional clinical testing;

 All
of our current data for tecarfarin are the results of clinical trials conducted by third parties;

 Our development efforts may not generate data sufficient to support regulatory
approval and the U.S. Food and Drug Administration (the "FDA") may require additional clinical testing;

 Even
if we complete our clinical trials, we may not receive regulatory approval for tecarfarin;

 Fast
Track designation and Orphan Drug Designation by the FDA does not assure FDA approval;

 Even
if we obtain regulatory approval, we may not enjoy marketing exclusivity and we may face development, regulatory or labeling difficulties;

 Clinical
trials are very expensive, time-consuming and difficult to design and implement.

 We
may experience delays in the enrollment of patients in any or all of our clinical trials;

 If
tecarfarin is approved, our success depends on our commercialization efforts and market acceptance;

 We
have never submitted an NDA to the FDA or comparable applications to other regulatory authorities;

 After
approval of tecarfarin, it will remain subject to regulatory obligations and other restrictions;

 We
are subject to federal and state obligations and regulations applicable to our marketing practices;

 We rely on third-party manufacturers to produce tecarfarin;

 If
the manufacturer fails to comply with stringent regulations, we may face delays;

 We
face substantial competition;

 Serious
adverse effects may be identified with respect to our products, which may harm our business;

 Recently
enacted and future legislation may affect marketing approval and commercialization of tecarfarin;

 We
may be subject to penalties if we violate healthcare fraud and abuse laws or price reporting laws;

 Our
ability to generate product revenues will be diminished if our products sell for inadequate prices;

 The impact of recent healthcare reform legislation in healthcare spending;

 We
 will rely on third parties to conduct all of our clinical trials;

 We
currently have limited distribution, marketing, support and sales capabilities;

 Our
employees, contractors, consultants, commercial partners and vendors may engage in misconduct;

 If
we are not successful in establishing a sales force, our ability to generate sales and profits will be limited;

 We plan to rely on third parties to develop, commercialize, market and
promote our products;

 Our
future growth depends, in part, on our ability to penetrate foreign markets;

 Global
health crises may adversely affect our planned operations; and

 Compliance
with regulations regarding the treatment of animals could increase our costs.

 Risks Related to Our Intellectual Property

 We
may be unable to obtain and maintain market exclusivity or patent protection for tecarfarin;

 We
may become involved in intellectual property lawsuits, which could be costly and time consuming;

 Patent
law changes in the United States and other jurisdictions could diminish the value of patents;

 Patent
protection depends on compliance with requirements imposed by governmental patent agencies;

 We
may not be able to enforce our intellectual property rights throughout the world; and

 Our U.S. patents have expired and our foreign patents will expire in
April 2025.

 Risks Related to Ownership of Our Common
Stock

 An
active public trading market for our Common Stock may not be maintained;

 We
cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market;

 Our
stock price has been extremely volatile;

 If
favorable research or reports about us are not published our stock price could decline;

 Our
officers, directors, and principal stockholders exercise significant control over our Company;

 Sales of Common Stock could result in dilution and depress the market price
of our Common Stock;

 Our
charter documents have anti-takeover provisions;

 Claims
for indemnification by our directors and officers may reduce our available funds;

 We
do not intend to pay dividends in the foreseeable future;

 We
have incurred significant increased costs as a result of operating as a public company;

 We
are an emerging growth company and may avail ourselves of reduced disclosure requirements or extended transition periods for complying
with new or revised accounting standards;

 There
is no public market for our outstanding warrants; and

 Holders
of our outstanding warrants will have no rights as common stockholders with respect to the shares of our Common Stock underlying the
warrants until such holders exercise their warrants and acquire our Common Stock, except as otherwise provided in the warrants.

 General Company-Related Risks

 Our
business depends upon our ability to attract and keep senior management and key scientific personnel;

 We
will need to increase the size of our organization, and we may experience difficulties managing this;

 If
product liability lawsuits are brought against us, we may incur substantial liabilities;

 Computer
system failures could be costly and expose us to litigation and government enforcement actions;

 We are increasingly dependent on information technology and our systems
face certain risks;

 Acquisitions
of other businesses could harm our operating results; and

 Declining
general economic or business conditions may have a negative impact on our business.

 Item 1. Business.

 Overview –

 We are developing tecarfarin, our drug candidate, for
unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) designed
to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions requiring chronic anticoagulation.

 There is a lack of approved anticoagulation therapies for certain rare
cardiovascular conditions requiring chronic anticoagulation, such as patients with left ventricular assist devices (LVADs), patients with
end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with catastrophic or thrombotic anti-phospholipid syndrome
(APS). For patients with these conditions, treatment guidelines, and not FDA-approved labeling, recommended the use of a vitamin K antagonist
(VKA) such as warfarin, despite warfarin's acknowledged challenges in achieving sufficiently stable and reliable anticoagulation
in these patients. Additionally, direct-acting oral anticoagulants (DOACs) like Eliquis and Xarelto have either not shown clinical benefits
in these and certain other patient populations, or their efficacy and safety remain uncertain.

 At the time the initial investigational new drug (IND) application
for tecarfarin was filed by its initial sponsor, warfarin was the only marketed oral anticoagulant, and the strategy was to develop tecarfarin
as an alternative VKA with superior efficacy and safety over warfarin for a broad range of indications including AFib, deep vein thrombosis
(DVT), pulmonary embolism (PE), prevention of pulmonary embolism in patients with venous thrombosis, DVT prevention in patients undergoing
certain surgical procedures, thrombosis prevention in patients with mechanical heart valves, and prevention of thrombotic complications
in patients after a myocardial infarction (heart attack), among others.

 While tecarfarin clinical trials were being conducted by the initial
IND sponsor, the DOACs were advancing through clinical trials and ultimately approved after demonstrating that they were non-inferior
to warfarin in certain indications, including AFib in the general population, prevention of pulmonary embolism in patients with venous
thrombus, and prevention of deep vein thrombosis in patients undergoing certain surgical procedures, among others. These DOAC clinical
studies resulted in a change in the standard of care for a large percentage of the population that had been previously treated with warfarin,
and some of the same population that was initially targeted by prior tecarfarin IND sponsor. Thus, the original broad-label development
plan for tecarfarin became much more challenging.

 Accordingly, we are focusing the development of tecarfarin for rare
cardiovascular conditions where patients are unable to achieve sufficiently reliable chronic anticoagulation with warfarin, and where
DOACs have either failed or their efficacy and safety remain unproven. These include patients with LVADs, patients with ESKD and AFib,
patients with mechanical heart valves and ESKD or resistant to warfarin, and patients with catastrophic or thrombotic APS, among others,
where the need for VKA-dependent chronic anticoagulation has been underscored by recent clinical studies. While warfarin-treated patients
have fared better than DOAC-treated patients in comparative studies in certain of these cardiovascular conditions, the event rates in
these studies remain unacceptably high and the quality of anticoagulation in warfarin-treated patients has repeatedly been shown to be
sub-optimal – hence, there continues to be unmet medical needs surrounding the use of warfarin in these patients that are not addressed
– or not addressable - by DOACs.

 Recent Developments

 Abbott Collaboration

 On March 3, 2025, we entered into a Collaboration
Agreement (the "Collaboration Agreement") with Abbott Global Enterprises Limited ("Abbott") to collaborate on
the Phase 3 randomized, warfarin-controlled, multicenter study with an open-label extension being sponsored by us, entitled "TECarfarin
Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices" (TECH-LVAD; the "Study"), to evaluate the
efficacy and safety of tecarfarin in patients with a left-ventricular assist device (the "Study Device").

 Pursuant to the Collaboration Agreement, Abbott
has agreed to share with us data collected by it on the LVAD population from its MOMENTUM 3 and ARIES HeartMate 3 US IDE trials and further
grant us a non-exclusive, limited, non-transferable, non-sublicensable license to use the data for the purposes of the Study, including
support for protocol development, as well as regulatory submissions related to the Study. We will be the regulatory sponsor of the Study
and will have the obligations of the sponsor pursuant to applicable laws, including, without limitation, monitoring of the Study and interacting
with regulatory authorities with respect to the Study. We are pursuing business development strategies, including licenses and funding
partnerships, to support funding the Phase 3 Study.

 Under the terms of the Collaboration Agreement,
Abbott will support us on the planning and execution of the TECH-LVAD trial to evaluate the efficacy and safety of tecarfarin
in patients with LVADs. Under the Agreement, Abbott will share insights from recent HeartMate 3 trials and will support us with:
biostatistics and trial design, site identification, trial awareness including patient identification and recruitment, and HeartMate 3
expertise.

 On March 5, 2025, we received from the FDA Type
D Meeting Minutes from our February 3, 2025 meeting with the FDA. The FDA acknowledged that designing a superiority trial in the intended
population may not be feasible, but stated that in principle they could support a primary composite clinical endpoint in a non-inferiority
trial as a possible path forward. To facilitate further discussion, the FDA has requested that we submit a full study design synopsis
along with adequate detail pertaining to key design features for FDA review of the IND.

 Background

 The quality of anticoagulation provided by VKAs has been defined by
the assessment of "time in therapeutic range" (TTR) blood tests. This measurement quantifies the percentage of time that a
patient's International Normalized Ratio (INR), a measure of the degree of anticoagulation achieved, is in the target range. A TTR of
70% is generally accepted as the benchmark for well-controlled anticoagulation, however most studies have shown that warfarin frequently
fails to achieve this target, even in optimally controlled clinical trials. A major contributing factor to the failure of warfarin in
achieving a reliable degree of anticoagulation in these circumstances is its metabolism. Specifically, warfarin is metabolized via the
cytochrome p450 (CYP450) pathway which creates opportunities for unstable and highly variable pharmacokinetics (PK) due to 1) a large
number of other drugs that also use this pathway (i.e. competition for the pathway which has limited capacity), 2) genetic variability
in components of the pathway that result in altered rates of metabolism and 3) a number of drugs alter the activity of components of the
pathway, either increasing or decreasing activity and therefore increasing or decreasing clearance of drugs metabolized by the pathway.
The result can be highly variable PK which translates into unstable levels of anticoagulation.

 In 2019, tecarfarin was granted an orphan drug designation (ODD) by
the United States Food and Drug Administration (FDA) for the prevention of systemic thromboembolism (blood clots) of cardiac
origin in patients with ESKD and AFib, and a fast-track designation was granted by the FDA in 2023. Patients with ESKD and AFib have very
high rates of stroke and death however, there is no standard of care for these patients since there has never been a study demonstrating
benefit of any anticoagulant in these clinical circumstances, largely due to the unacceptable risk of placebo controls. There are more
than 809,000 Americans with ESKD, with approximately 70% on dialysis. Approximately 100,000 to 150,000 ESKD patients also have AFib. AFib
nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients. There are currently
no effective anticoagulation treatment options for patients with ESKD and AFib. Commonly prescribed medications, such as warfarin and
apixaban (Eliquis), may cause substantial harm in circumstances of excessive anticoagulation, leading to outcomes such as hemorrhagic
stroke, major bleeding, or death, and most trials of anticoagulant therapy to reduce the risk of such events have excluded these patients
because approved therapies for AFib have metabolic profiles that may increase drug exposure in patients with impaired renal function,
thereby increasing known risks and challenges in managing patients with ESKD and AFib.

 In 2024, tecarfarin was granted ODD by the FDA for the prevention of
thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes left
ventricular assist device (LVAD), a heart pump. There are approximately 15,000 patients in the U.S. with LVADs, and recent randomized
controlled trials in LVAD patients have documented that currently available VKAs (warfarin) yield relatively poor quality anticoagulation
(as reflected by the TTR) despite the attempts at tight management of anticoagulation in the clinical trial setting. Implantable LVAD
therapy is used to improve quality of life, alleviate symptoms, and extend survival rates in patients with advanced heart failure, irrespective
of eligibility for cardiac transplant. Patients with LVADs require chronic anticoagulation to reduce the risk of thromboembolic complications,
and under the currently available anticoagulants, they commonly experience bleeding events. LVAD patients require life-long anticoagulation
to reduce the risk of pump thrombosis and anticoagulation management in patients with LVADs continues to be a challenge. Patients and
their clinicians are faced with the daily challenge of balancing the need for adequate anticoagulation versus the bleeding risks that
are associated with excess anticoagulation. Warfarin is the only available oral anticoagulant for all currently available LVAD devices,
however, warfarin is known to be a difficult medication to manage due to its labile metabolism, and its many drug-drug interactions.

 The FDA grants ODD status to drugs that are intended
for the treatment, diagnosis, or prevention of rare diseases or conditions, which are defined as a disease or condition that affect fewer
than 200,000 people in the U.S. The ODD program provides a drug developer with certain benefits and incentives, including a seven-year
period of U.S. marketing exclusivity from the date of marketing authorization, waiver of FDA user fees, and tax credits for clinical research.
The granting of an orphan drug designation does not alter the FDA's regulatory requirements to establish safety and effectiveness
of a drug through adequate and well-controlled studies to support approval and commercialization. Furthermore, orphan drug designation
does not indicate or guarantee FDA approval of the New Drug Application, or NDA, and we might not receive exclusivity. On January 13,
2023, the FDA designated a Fast Track development program for the investigation of tecarfarin for the prevention of systemic thromboembolism
of cardiac origin in patients with ESKD and AFib. Fast Track is a process designed to facilitate the development and expedite the review
of drugs to treat serious conditions and fill an unmet medical need.

 In patients with LVADs, recent data also highlight the need for a next
generation VKA anticoagulant. The ARIES-HM3 study was designed to evaluate the need for chronic aspirin treatment in patients with the
newest LVAD, the HeartMate3. The use of aspirin in LVAD patients was standard but had never been proven to be beneficial. The ARIES study
randomized LVAD patients to continue aspirin, along with warfarin, versus warfarin alone. The main finding of the study revealed that
aspirin is not helpful in LVAD patients; however, since all patients were receiving warfarin and had careful monitoring of the quality
of anticoagulation, the study also provided the opportunity to determine if the quality of anticoagulation provided by warfarin, had an
impact on patient outcomes. The analysis of this carefully controlled and monitored study showed that the average TTR was only 56% with
warfarin, far below the benchmark for well-controlled anticoagulation of 70%, and that, despite the superior design of the HM3 device,
poor quality anticoagulation was associated with excess thrombotic and bleeding events.

 VKAs block the production of vitamin K-dependent blood clotting factors,
such that the blood is "thinned," preventing clots, while DOACs directly block the activity of single clotting factors. Vitamin
K epoxide Reductase Complex subunit 1 (VKORC1) is a significant enzyme for effective clotting. VKORC1 reduces vitamin K epoxide to its
active form (Vitamin K), which is the rate-limiting step in the physiological process of vitamin K recycling. Vitamin K serves as a cofactor
for normal function of several clotting/anticoagulation factors including Factors II, VII, IX and X and Proteins C, S, and Z. VKORC1 genetic
deficiencies result in increased sensitivity to VKAs, which results in an increase in the risk of significant hemorrhage. We believe tecarfarin
has potency for VKORC1 inhibition similar to warfarin, but it is an investigational new drug, and we will need to demonstrate it is safe
and effective for its proposed indication(s).

 Tecarfarin has been evaluated in eleven (11) human
clinical trials in over 1,000 individuals (269 patients were treated for at least six months and 129 patients were treated for one year
or more). In Phase 1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects
and patients with chronic kidney disease, or CKD. In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having
completed it (including those with mechanical heart valves), only 1.6% of the blinded tecarfarin subjects suffered from major bleeding.

 Tecarfarin is metabolized via a different metabolic pathway, the human
carboxylesterase 2 pathway, thereby avoiding CYP450 metabolism in the liver. This pathway is abundantly distributed through the body –
not confined to the liver like CYP450, and although it has genetic variability, the variants have not been shown to significantly alter
drug clearance. In contrast, patients taking multiple medications that interact with CYP2C9, or CYP3A4, or those with impaired kidney
function, can experience an overload in the pathway, creating a bottleneck that often leads to insufficient clearance, which results in
the unstable levels of anticoagulation that are well documented with warfarin use. This has been demonstrated in clinical studies to result
in more reliable levels of anticoagulation in certain patients at higher risk for CYP450 issues. In the EMBRACE-AC study of 607 patients,
the time in therapeutic range (TTR) was used to compare tecarfarin to warfarin. TTR quantifies the percentage of International Normalized
Ratio (INR) values that are in the appropriate range. When the INR values collected in tecarfarin and warfarin were compared, tecarfarin
TTR was significantly better than warfarin in patients at higher risk for CYP450 issues. This was especially notable because a blinded
team of experts reviewed all INR values (for both tecarfarin and warfarin) and made dose adjustments which resulted in the TTR of warfarin
being even higher than commonly observed in "real world" settings.

 Atrial fibrillation (AFib) is the most frequently encountered human

 arrhythmia, with its incidence and prevalence increasing over the last 20 years. AFib is associated with an approximate
five-fold increased risk of stroke. The risk of developing AFib increases in patients with CKD. According to 2021 estimates by the Centers
for Disease Control and Prevention, or CDC, approximately 15% of the U.S. adult population, or 37 million people, have CKD. An estimated
0.4% of people in the U.S. suffer from Stage 4 CKD and 0.1% of people in the U.S. have ESKD.

 There are more than 809,000 Americans with ESKD, with approximately
70% on dialysis, according to the United States Renal Data System. Approximately 100,000 to 150,000 ESKD patients also have AFib. AFib
nearly doubles the anticipated mortality and increases the stroke risk by approximately five-fold in these patients. There is evidence
that AFib is an independent risk factor for developing ESKD in CKD patients. Both diseases share common risk factors including hypertension,
diabetes, vascular disease, and advancing age. Cardiovascular disease contributes to more than half of all deaths among patients with
ESKD. According to the Annual Data Report published by the United States Renal Data System, total Medicare spending for patients with
ESKD reached $50 billion in 2023, accounting for approximately 7% of the Medicare-paid claims costs.

 Patients with ESKD and AFib have very high rates
of stroke and death however, there is no standard of care for these patients since there has never been a study demonstrating the benefit
of any anticoagulant. These patients have typically been excluded from randomized clinical trials because the approved therapies for AFib
have metabolic profiles that may increase drug exposures, thereby increasing the known risks and challenges in managing these patients.
The presence of either CKD or AFib, increases the risk of serious thromboembolic adverse clinical outcomes, such as stroke and death.
Antithrombotic therapy is typically recommended to decrease this risk in AFib patients, but there are no approved treatment options for
patients with ESKD and AFib. Warfarin may cause substantial harm in these patients. Low-dose apixaban (Eliquis) was approved by the FDA
for use in ESKD patients on hemodialysis based upon limited pharmacokinetic data from 8 subjects. Although randomized trials of apixaban
versus warfarin for AFib have been conducted, those studies excluded patients with severe and end-stage kidney disease. The RENAL-AF (Trial
to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation) was terminated early in 2019 by its sponsor. Accordingly,
there is no evidence to support the use of any drug for the prevention of thromboembolic events in patients with ESKD and AFib.

 Clinical Trials

 Tecarfarin has been evaluated in 11 human clinical
trials in over 1,000 individuals, which includes eight Phase 1 trials, two Phase 2 trials, and one Phase 2/3 trial evaluating the efficacy
and safety of tecarfarin.

 In a Phase 2/3 randomized and blinded trial sponsored by ARYx Therapeutics,
Inc. in 2008 (EMBRACE -AC study), 607 patients with a variety of indications for chronic anticoagulation were treated with either tecarfarin
or warfarin. The primary endpoint of the study was the Time in Therapeutic Range, or TTR, which quantifies the percentage of time a patient
is at the desired level of anticoagulation. The degree of anticoagulation is measured by the INR (international normalized ration) which
measures the clotting ability of the blood. Individuals with normal clotting ability have an INR of ~1. When a patient is on anticoagulation
with a VKA such as warfarin the target range of the INR is usually from 2-3. In clinical practice, the dose of a VKA is adjusted based
on periodic measurement of the INR. If the INR is too low, then the dose of VKA is increased, and if it is too high, then the dose of
VKA is decreased. Studies of warfarin have shown that the TTR in real-world practice is typically around 50-55%, while the benchmark for
well-controlled anticoagulation is a TTR of 70%.

 In the EMBRACE -AC study comparing warfarin to tecarfarin, there was
a committee of experts that reviewed every INR in every patient. As a result, the TTRs in this study were higher than in general practice.
The trial did not meet its primary endpoint of superiority of tecarfarin over warfarin using the interpolation method of calculating TTR.
However, despite this intense oversight of dose adjustment, the INRs actually measured were evaluated and the TTRs for tecarfarin was
significantly higher than the TTR in a subset of warfarin-treated patients who might be expected to have challenges with CYP450 metabolism.
Tecarfarin appeared to be well tolerated with only 1.6% of the blinded tecarfarin subjects suffering from major bleeding and no thrombotic
events. When thrombotic and major bleeding events during the blinded period were combined, a numerical imbalance (but not statistical
significance) favoring tecarfarin over warfarin was seen (warfarin 11 subjects, 3.6%; tecarfarin 5 subjects, 1.6%).

 In a subsequent Phase 1 study with 23 patients
with CKD sponsored by Armetheon, Inc. in 2016, the metabolism of warfarin was shown to be significantly inhibited, whereas tecarfarin
metabolism was not altered in the setting of significant renal insufficiency. The safety of repeated dosing of tecarfarin in CKD patients
was not evaluated in that study. However, if the pharmacokinetic findings of this single-dose study are present with repeated dosing,
tecarfarin may have more predictable levels of anticoagulation than warfarin in severe CKD patients.

 Our Strategy

 Our goal is to build a biopharmaceutical company
with a foundation of product candidates that significantly advance patient care in rare cardiovascular conditions. Key elements of our
strategy are as follows:

 Progress the clinical development of and seek FDA approval for tecarfarin
for patients with unmet needs in anticoagulation therapy. We intend to initiate a pivotal Phase 3 clinical trial in late 2025 or early
2026, subject to funding from additional financings, for at least one indication. We believe, a single pivotal trial, if successful, could
be sufficient for NDA filing.

 If we obtain FDA approval of our NDA for our first indication, we intend
to seek to expand the label for tecarfarin through a supplemental NDA. We ultimately intend to explore the full potential of tecarfarin
in a number of potential indications, including chronic anticoagulation in patients with LVADs, patients with ESKD and AFib, patients
with ESKD and mechanical heart valves, patients with APS, and patients with other thrombophilic disorders who would otherwise require
chronic anticoagulation with warfarin.

 An LVAD is an implantable pump attached to the heart, connecting
the apex of the left ventricle to the ascending aorta. LVADs are intended to treat patients suffering from advanced heart failure.

 APS is an autoimmune disorder characterized by an increased
tendency to form abnormal blood clots, which can form in nearly any blood vessel in the body, and which can also cause miscarriages in
women.

 A mechanical heart valve is a prosthetic device implanted in the heart
to replace the function of normal heart valves – tricuspid, pulmonic, mitral, and aortic.

 If we receive acceptable feedback from the FDA regarding our trial
protocol, and subject to funding from additional financings and/or partnerships, we may choose to advance tecarfarin in patients with
LVADs as our first indication. We may choose to conduct a pilot/proof-of-concept study prior to a pivotal trial.

 We
intend to partner and/or in-license and/or acquire clinical-stage cardiovascular products to augment our current pipeline, which consists
of one investigational product.

 Create a commercial infrastructure for our product candidates.
If tecarfarin is approved by the FDA, we intend to expand our commercial infrastructure and hire and train a focused and dedicated specialty
salesforce which we believe can efficiently cover the top prescribing physicians and approximately 3,000 anticoagulation clinics in the
U.S., which presently monitor patients on warfarin.

 Our Investigational Product Candidate

 Tecarfarin for Use in Patients with LVADs

 We have ODD for the prevention of thrombosis and
thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes left ventricular assist
device (LVAD), a heart pump. There are approximately 15,000 patients in the U.S. with LVADs, and therefore, this meets the prevalence
requirement of fewer than 200,000 patients.

 Implantable left ventricular assist device (LVAD)
therapy is used to improve quality of life, alleviate symptoms, and extend survival rates in patients with advanced heart failure, irrespective
of eligibility for cardiac transplant. Patients with LVADs require chronic anticoagulation to reduce the risk of thromboembolic complications,
and they commonly experience bleeding events. Recent data reveals that the current standard of care anticoagulant, warfarin, yields suboptimal
levels of anticoagulation, leading to excess bleeding complications.

 LVAD patients require life-long anticoagulant
therapy to reduce the risk of pump thrombosis. Anticoagulation management in patients with LVADs continues to be a challenge. Patients
and their clinicians are faced with the daily challenge of needing adequate anticoagulation versus the bleeding risks that are associated
with anticoagulation. Warfarin is the recommended oral anticoagulant for all currently available LVAD devices, however, warfarin is known
to be a difficult medication to manage due to its narrow therapeutic window, and its many interactions. Recent data also highlights the
need for a next generation VKA anticoagulant. The ARIES-HM3 study was designed to evaluate the need for chronic aspirin treatment in patients
with the newest LVAD, the HeartMate3. The use of aspirin in LVAD patients was standard but had never been proven to be beneficial. The
ARIES study randomized LVAD patients to continued aspirin, along with warfarin. The main finding of the study revealed that aspirin is
not helpful in LVAD patients; however, since all patients were receiving warfarin and had careful monitoring of the quality of anticoagulation,
the study also provided the opportunity to determine if the quality of anticoagulation provided by warfarin, had an impact on patient
outcomes. The predominant findings showed that the average TTR was only 56% with warfarin, far below the benchmark for well-controlled
anticoagulation of 70%, and that, despite the superior design of the HM3 device, poor quality anticoagulation was associated with excess
thrombotic and bleeding events.

 Tecarfarin for Use in Patients with ESKD
and AFib

 Thrombosis is the formation or presence of a blood
clot (a thrombus) within a blood vessel that blocks normal blood flow. A formed thrombus can detach from the vessel or heart atrium wall,
resulting in a thromboembolism that causes a blockage of the blood flow to vital organs, such as the brain, heart and lungs. According
to the CDC, each year, approximately 800,000 people in the U.S. experience a new or recurrent stroke, of which approximately 87%
are ischemic strokes, which are caused by either a thrombotic event or embolism, in which blood flow to the brain is blocked. In addition,
the CDC estimates that as many as 900,000 people in the U.S. could be affected by venous thromboembolism (blood clotting in the veins)
or a pulmonary embolism (blood clotting in the lungs) each year.

 Types of Anticoagulants

 The prevailing treatment for patients at risk
of thrombosis is an oral anticoagulant of which there are two common types: vitamin K antagonists, or VKAs, and direct oral anticoagulants,
or DOACs.

 Vitamin K Antagonists: Warfarin

 Vitamin K antagonists, or VKAs, are substances
that block the production of vitamin K-dependent blood clotting factors such that the blood is "thinned," preventing
clots. VKAs are used as anticoagulants in the prevention or treatment of thrombosis. For patients treated with a VKA, the international
normalized ratio, or INR, a system established by the World Health Organization and the International Committee on Thrombosis and Hemostasis,
is a commonly available, inexpensive measure of the body's coagulation status. Each VKA patient's dose must be individualized,
based on a target range for his or her INR test. The percentage of time that a patient's INR is maintained within his or her target
range is known as the time in therapeutic range, or TTR. TTR is a surrogate endpoint used to characterize the quality of anticoagulation
control (and, indirectly, safety and efficacy) of a VKA based on prothrombin time and the INR. When used as a therapy, VKAs are titrated
to a patient's individual INR range and that patient is expected to visit a clinic for regular INR monitoring or use a home INR
monitoring system. A higher TTR reflects better anticoagulation control and is related to improved clinical outcomes, including rates
of death, bleeding, myocardial infarction, stroke and systemic embolism, and a TTR measure of 70% is generally accepted as the benchmark
for well-controlled anticoagulation. When patients are above their individual INR range, they are at higher risk for bleeding, due
to reduced clotting ability, while patients are below their target INR range are at higher risk for thrombotic events. Potential benefits
of monitoring INR include ascertaining patient compliance with their drug treatment regimen, the ability to detect when dose adjustments
are needed and maintaining safety and efficacy of the drug treatment. TTR is predictive of adverse events, including mortality, stroke
and myocardial infarction.

 As depicted in the chart below, higher TTR is
generally correlated with higher survival rates.

 Source: Currie et al. Heart 2006 (92) 196-200

 Impaired kidney function, as measured by marked
reductions in glomerular filtration rate (eGFR), are also associated with much lower TTR, as reported in the Journal of the American Heart
Association in 2017.

 VKAs are reversible, meaning that in cases of
over-anticoagulation, vitamin K or fresh frozen plasma, or a combination, can be administered to bring patients back down into their INR
range.

 Warfarin is currently the predominant VKA treatment
option in the U.S. and has been in use since the early 1950s. However, as reported by the National Center for Biotechnology Information,
there are many adverse events associated with warfarin, including bleeding, skin necrosis and hair loss; notably, warfarin, with substantial
risk of drug-drug interactions, has been reported as number three on the list of drugs implicated in adverse effects causing hospital
admission. Due to these side effects and the increasing availability of DOACs, the use of warfarin has decreased during the last decade,
but it still remains a mainstay of therapy in some clinical circumstances.

 Limitations of Warfarin Treatment

 Warfarin has significant safety risks stemming
from its metabolism, including its pathways for elimination. Other commonly appreciated drawbacks of warfarin include a relatively narrow
therapeutic range, requirements for monitoring and adjustment, slow onset (with initial paradoxical prothrombotic effects due to its early
inhibition of proteins C and S) and a relatively slow offset of action (making it difficult to manage with invasive procedures),
and multiple drug and food interactions.

 Warfarin's efficacy and safety profile are
affected by its metabolism and elimination characteristics and various interactions with other drugs. Warfarin is metabolized through
the CYP450 pathway, primarily by the CYP2C9 enzyme, and approximately 15% of clinically used drugs are metabolized by the same enzyme,
including certain anticoagulants, antiplatelets and non-steroidal anti-inflammatory drugs. Patients taking warfarin and
on CYP2C9 interacting drugs may experience either warfarin being eliminated by the body too quickly, thereby decreasing its anticoagulation
effect, or warfarin being eliminated by the body too slowly, resulting in excessive and dangerous thinning of the blood. In both of these
situations, frequent monitoring is required and dose adjustments are often necessary. Patients who take both warfarin and these CYP2C9
interacting drugs also have an increased risk of being outside their individual INR target range and experiencing lower TTR. For
these patients, their CYP2C9 interacting drugs must be used with caution, or at times, they may need to be discontinued.

 Warfarin's efficacy and safety profile can
also be affected by genetic mutations that lead to a lower activity of the CYP2C9 enzyme. Clinical studies have shown that these individuals
may require lower dosages of warfarin and are at an increased risk of excessive anticoagulation – and bleeding – with standard
doses.

 Currently, warfarin is frequently used in patients
with non-valvular AFib and in patients with valvular heart diseases (VHD) with AFib. However, as reported by an article published
by the Egyptian Heart Journal on March 28, 2022, an analysis of 6,454 patients with AFib taking warfarin showed that almost 50% of
the time the INR was outside the target range of 2–3, leading to a higher risk of bleeding and thrombotic complications. The major
adverse effect associated with warfarin is bleeding, and major and fatal bleeding events occur at rates of 7.2 and 1.3 per 100 patient-years,
respectively, according to a meta-analysis of 33 studies.

 INR needs to be even more frequently monitored
in patients with impaired kidney function, who are known to have a decreased ability to metabolize drugs through the CYP450 pathway, and
accordingly have an increased risk of being outside their individual INR target range and experiencing lower TTR. Further, according
to an article published by Frontiers in Medicine in January 2021, warfarin was associated with an increase in the risk of major bleeding
without reduction in stroke/thromboembolism or mortality in patients with end-stage CKD requiring dialysis.

 Illustrating the challenges with warfarin, trials
have shown that patients treated with warfarin often experience TTRs much lower than 70%, generally accepted as the benchmark for well-controlled
anticoagulation. In a 2019 study conducted to evaluate TTR in 300 patients on long-term warfarin for non-valvular AFib, as reported
by an article published in Health and Quality of Life Outcomes on October 20, 2020, 75.5% of patients had a poor TTR with a mean
of only 39.5%, with the mean TTR of all patients in the study being 47%. In another study of 406 AFib patients conducted in Lithuania
to evaluate the quality of warfarin as anticoagulation therapy, more than half (57.3%) of INR values were outside of the target range,
the median TTR was only 40%, and only 20% of patients had a TTR greater than or equal to 65%.

 Direct Acting Oral Anticoagulants (DOACs)

 DOACs, are a form of treatment that inhibits certain
blood clotting factors. While VKAs block the synthesis of vitamin K-dependent blood clotting factors (II, VII, IX, X, protein
C and protein S), DOACs block the activity of specific clotting factors. There are two classes of DOACs, oral direct thrombin inhibitors
(which act against Factor IIa) and oral direct factor Xa inhibitors. Currently, there are only four DOACs approved by the FDA for use
outside of a hospital setting: apixaban (the generic name for Eliquis), dabigatran (the generic name for Pradaxa), rivaroxaban (the generic
name for Xarelto) and edoxaban (the generic name for Savaysa). DOACs are generally more rapid in onset and offset of action than VKAs,
have few strong drug-to-drug interactions and do not require INR monitoring.

 Limitations of DOAC Treatment

 DOACs have been approved in the U.S. for
the treatment of specific oral anticoagulation indications; however, there are a number of clinical scenarios for which DOACs are contraindicated
or simply not recommended for use, including for anticoagulation treatment in patients with LVADs, patients with ESKD and AFib, patients
with ESKD and mechanical heart valves, and patients with thrombotic APS. DOACs do not have the same broad label indication as warfarin
and are only indicated for some thrombosis indications.

 Our Proposed Solution: Tecarfarin for Treatment
of Patients with LVADs, ESKD and AFib, ESKD and mechanical heart valves, and thrombotic APS

 Tecarfarin, our lead investigational product candidate,
is a VKA, once-daily oral anti-coagulant. The primary differentiating feature of tecarfarin is that it is metabolized via a different
metabolic pathway than warfarin. However, like warfarin, tecarfarin will still require INR monitoring. Tecarfarin is eliminated by large
capacity, non-saturable tissue esterase pathways that exist throughout the body, rather than just in the liver. This is distinct
from the CYP450 pathway and infrequently used by other medications, which could potentially reduce the risk for drug-to-drug interactions.
Moreover, unlike warfarin, tecarfarin's metabolism does not appear to be affected by CYP2C9 genetic variant alleles or by kidney
function.

 Given the metabolic process and related safety
issues with warfarin and the limited treatment indications for which DOACs are approved, we believe there is a significant thrombosis
patient population in need of an alternative anticoagulation treatment. The lack of stable and predictable anticoagulation control is
particularly problematic in large underserved patient subpopulations with risk factors such as:

treated with CYP2C9 interacting drugs;

with severely impaired kidney function;

with genetic variant alleles for CYP2C9;

with LVADs;

with mechanical heart valve implants; and

treated with thrombotic APS

 Tecarfarin Clinical Program

 Tecarfarin
has been evaluated in eleven clinical trials: eight Phase 1 trials, two Phase 2 trials and one Phase 2/3 trial evaluating
the efficacy and safety of tecarfarin.

 A summary of the clinical trials conducted to
date with tecarfarin is shown below.

 Study Number

 Study Description

 Study
 Population

 Number
 Exposed

 Date started

 Date completed

 Sponsor

 ZK-TEK-201905

 Multiple-dose tolerance and PK-PD study of tecarfarin

 Healthy Chinese Volunteers

 2020

 January 2021

 Zhaoke Pharmaceutical (Guangzhou) Co., Ltd

 LP-HK-001

 Phase 1, Sequential Cohort, Single-dose escalation study

 Healthy Chinese Volunteers

 June 2018

 July 2019

 Lee's Pharmaceutical (Hong Kong) Limited

 CLN-512

 Phase 1 pharmacokinetic study in chronic kidney disease subjects

 Chronic kidney disease subjects; healthy volunteers

 November 2015

 May 2016

 Armetheon, Inc.

 CLN-505

 Phase 2/3 randomized, blinded head-to-head anticoagulation in broad indications (EMBRACE-AC)

 Patients (all indications)

 June 2008

 December 2009

 ARYx

 CLN-509

 Pilot Phase 2 study for trial methodology to be used in CLN-505

 Patients (all indications)

 January 2008

 August 2008

 ARYx

 CLN-504

 Phase 2a open-label anticoagulation in AFib

 Patients Requiring Oral Anticoagulation

 December 2006

 October 2007

 ARYx

 CLN-508

 Phase 1 DDI study with amiodarone

 July 2007

 September 2007

 ARYx

 CLN-507

 Phase 1 DDI study with fluconazole

 June 2007

 August 2007

 ARYx

 CLN-503

 Phase 1 Dose titration to target

 October 2006

 January 2007

 ARYx

 CLN-502

 Phase 1 Effect on INR in multiple dose response

 November 2005

 July 2006

 ARYx

 CLN-501 & CLN-501.X

 Phase 1 Safety and human pharmacokinetics

 August 2005

 April 2006

 ARYx

 Phase 1 Studies

 Tecarfarin has been studied in five Phase 1 clinical
trials in a total of 133 healthy volunteers.

 The effects of tecarfarin were evaluated in two
Phase I single-dose studies and a Phase I multiple-dose study, all of which showed no serious side effects and dose-related prolongation
of the INR to the target range after 3 to 14 days of dosing.

 Another multiple-dose study examined the relationship
between the vitamin K-dependent coagulation factors and INR in subjects treated with either warfarin or tecarfarin. This study showed
that the pattern of coagulation factors for tecarfarin were virtually identical to that of warfarin, and tecarfarin was as well tolerated
as warfarin.

 Other studies looked at interactions with a moderate
CYP2C9 inhibitor (amiodarone) and a strong CYP2C9 inhibitor (fluconazole), on the PK and PD of warfarin and tecarfarin. The co-administration
of amiodarone resulted in relatively small increases in drug exposure and INR, but for S-warfarin and racemic warfarin the mean area under
the concentration versus time curve from time 0 to 24 hours (AUC0-24) was significantly increased. The co-administration of fluconazole
prolonged the t of both R- and S-warfarin (from 48 to 104 hours and from 37 to 82 hours, respectively); drug exposure (AUC0-168)
was increased 186% and 256%, respectively. The PK of tecarfarin were unaffected by fluconazole co-administration. Both warfarin and tecarfarin
were well-tolerated.

 Tecarfarin was also studied in an open-label randomized
crossover single dose PK study with warfarin in 10 healthy volunteer subjects and 10 patients with severe chronic kidney disease. This
study demonstrated that exposure to tecarfarin (as measured by AUC and Cmax) was similar between the CKD and healthy subjects. In contrast,
exposure to warfarin showed significant increases of both AUC and Cmax and decreases in clearance for (S)-warfarin and (R,S)-warfarin
in subjects with CKD as compared to healthy subjects, especially so in patients who were either intermediate metabolizers of CYP2C9 or
concomitantly on a drug that inhibited CYP2C9.

 Two additional Phase 1 studies (single ascending
dose and multiple ascending dose) have been conducted in healthy Chinese patients to assess safety and tolerability. Tecarfarin was well
tolerated, and no serious adverse events were observed in either study; levels of tecarfarin were generally dose proportional.

 Phase 2 Trials

 CLN-504 was an open-label study
in which 66 patients with AFib were treated with tecarfarin for a period of six weeks. The trial was conducted by our predecessor
company that owned the rights to tecarfarin, and designed to determine an optimal dosing regimen and to describe the efficacy and quality
of anticoagulation as measured by TTR. Before entering the trial, warfarin-treated patients had a mean TTR of 59.4%. After the
initial three weeks of dose titration, the tecarfarin-treated patients were within the target INR range 71.4% of the time (p<0.001).
The most commonly reported treatment-related adverse events, or TEAEs, were mild hemorrhagic complications of anticoagulation, such
as bruising and epistaxis.

 CLN-509 was a pilot Phase 2 study to assess
clinical trial methodology for future studies in patients having a variety of clinical indications requiring chronic oral anticoagulation,
as measured by INR. Fifty patients with a variety of clinical indications for chronic oral anticoagulation, including patients with atrial
fibrillation, venous thromboembolic disease, prosthetic heart valves, and cardiomyopathy. received daily doses of tecarfarin ranging
from 1 mg to 60 mg adjusted to maintain their individual target INR values. INR control was achieved in all patients; there were no adverse
events due to tecarfarin and no clinically important safety signals.

 CLN-505 (EMBRACE-AC) was a Phase 2/3
trial multi-center, randomized, double-blind, parallel group, active control trial in 607 patients requiring chronic oral anticoagulation
designed to compare the quality of anticoagulation of tecarfarin and warfarin for a minimum period of six months (up to one year)
as determined by TTR. Dosing of study drugs was managed by a centralized dose control center. In EMBRACE-AC the mean TTR with
tecarfarin (the primary endpoint) was numerically higher but not significantly superior to warfarin in terms of the primary endpoint (72.3%
with tecarfarin vs 71.5% with warfarin; p=0.51).

 As part of its original analysis plan, EMBRACE-AC also
included analyses of INR measurements while patients were temporarily off their trial drug due to other medical reasons. In a subsequent
post-hoc analysis excluding these INR values while off therapy the mean TTR was significantly higher on tecarfarin (68.8%) than on
warfarin (66.4%) (p<0.04).

 Additional analyses of other patient subgroups
demonstrated:

 In
the 179 patients taking CYP2C9 interacting drugs, the TTR of patients taking tecarfarin was similar to that of patients taking warfarin
(72.2% and 69.9%, respectively; p=0.15).

 In
the 55 patients taking CYP2C9 interacting drugs who also had a CYP2C9 genetic variant allele, the TTR of patients taking tecarfarin was
similar to that of patients taking warfarin (76.5% and 69.5%, respectively; p=0.09).

 In
the 84 patients with mechanical heart valve implants, the TTR of patients taking tecarfarin was similar to that of patients taking warfarin
(68.4% and 66.3%, respectively; p=0.51).

 Notably,
TTR rates in patients treated with warfarin exceeded previously reported TTR rates for warfarin, which are typically in the 50% to 65%
range, which we believe, in retrospect, was largely due to the use of strict dosing protocols and the use of centralized dose adjustment
centers in the trial.

 The average daily doses required of both tecarfarin
and warfarin was also analyzed in patients who had poor, intermediate or extensive metabolism of CYP2C9. Patients with poor CYP2C9 metabolism
who were treated with warfarin required a significantly lower average daily dose compared to those patients with extensive CY2C9 metabolism.
In contrast, as depicted below, the required dosage of tecarfarin did not vary significantly based on the patient's CYP2C9 metabolic
activity level.

 The trial did have some limitations. Most importantly,
the TTR with warfarin achieved in EMBRACE-AC was much higher than that typically seen in clinical trials and as compared to "real-world
practice," exceeding 71% on an interpolated basis in both treatment arms. The most likely reason for this stemmed from the management
of study drug dosing (for both warfarin and tecarfarin) by a centralized dose control center, which provided a degree of oversight higher
than that seen on normal practice.

 Safety Data

 In EMBRACE-AC, the largest clinical trial to date,
with follow-up out to one year, tecarfarin appeared to be well tolerated with only 1.6% of the blinded tecarfarin subjects suffering from
major bleeding and no thrombotic events were observed. When thrombotic and major bleeding events during the blinded period were combined,
a numerical imbalance favoring tecarfarin over warfarin was seen (warfarin 11 subjects, 3.6%; tecarfarin 5 subjects, 1.6%).

 There were also comparable rates of treatment
emergent adverse events TEAEs – all adverse events observed, regardless of relationship to study drug) between the two treatment
groups. TEAEs were reported for 93.2% of patients who received tecarfarin and 90.5% of patients who received warfarin. TEAEs reported
by 10% of patients in either treatment group were nasopharyngitis (18.6% and 19.3%, blinded tecarfarin and warfarin, respectively),
contusion (15.6% and 14.8%, respectively), epistaxis (8.1% and 11.1%, respectively), upper respiratory tract infection (10.7% and 10.8%,
respectively), diarrhea (10.1% and 9.2%, respectively) and headache (10.7% and 8.9%, respectively). Most TEAEs were mild (32.2%, tecarfarin
and 30.2%, warfarin) or moderate (45.0% and 46.6%, respectively) in severity.

 Five patients died during the trial, with four
deaths occurring during the double-blind period: one patient (tecarfarin; off drug) died due to mantle cell lymphoma, pneumonia and
sepsis; one patient (tecarfarin; on drug) died due to cardiorespiratory arrest and myocardial infarction; one patient (warfarin; off drug)
died due to metastatic colon cancer; one patient (warfarin; off drug) died due to lung cancer; and one patient (not randomized) died due
to intracerebral hemorrhage. The patient who died due to intracerebral hemorrhage was considered to be possibly related to the study drug,
but the remaining four deaths were not attributed to the drug.

 During the blinded period of the trial, five patients
on tecarfarin and six patients on warfarin experienced major bleeding events. The occurrence of major bleeding events for both tecarfarin
and warfarin was lower when compared to prior anticoagulation trials. Among warfarin-treated patients, there were five thrombotic
events (two ischemic strokes, two deep vein thromboses and one pulmonary embolism), while there were no such events among tecarfarin-treated patients.

 Abbott Collaboration

 On March 3, 2025, we entered into the Collaboration
Agreement with Abbott to collaborate on the Phase 3 randomized, warfarin-controlled, multicenter study with an open-label extension being
sponsored by us, named "TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices" (the Study),
to evaluate the efficacy and safety of tecarfarin in patients with a left-ventricular assist device (the Study Device).

 Pursuant to the Collaboration Agreement, Abbott
will share with us data collected by it on the LVAD population via its MOMENTUM 3 and ARIES HeartMate 3 US IDE trials and further grant
us a non-exclusive, limited, non-transferable, non-sublicensable license to use the data for the purposes of the Study, including support
for protocol development, as well as regulatory submissions related to the Study. We will be the regulatory sponsor of the Study and will
have the obligations of the sponsor pursuant to applicable laws, including, without limitation, monitoring of the Study and interacting
with regulatory authorities with respect to the Study. We are pursuing business development strategies, including licenses and funding
partnerships, to support funding the Phase 3 Study.

 The Collaboration Agreement further provides that
we and Abbott will collaborate in the following areas related to the Study: (1) Biostatistics including Statistical Analysis Plan development,
(2) Site and investigator selection, (3) Site qualification/feasibility, (4) Patient identification and recruitment, and (5) Medical science
liaison support.

 The Collaboration Agreement provides that we will
own the Study data and grant Abbott a non-exclusive, royalty-free license to use the Study data for any of the following purposes: (i)
submissions to regulatory authority(ies) worldwide, including submissions relating to label changes or new indications for Abbott's
products; or (ii) research and development purposes relating to Abbott's products or (iii) compliance with applicable laws, including
with respect to safety reporting; or (iv) use of summary level Study data to support Study Device claims.

 Either party may terminate the Collaboration Agreement
without cause upon sixty days written notice to the other party and immediately upon a material breach by the other party of any provision
of the Collaboration Agreement.

 Planned Pivotal Phase 3 Trial in LVAD

 On March 5, 2025, we received FDA Type D Meeting
Minutes from our February 3, 2025 meeting. The FDA acknowledged that designing a superiority trial in the intended population may not
be feasible but stated that in principle they could support a primary composite clinical endpoint in a non-inferiority trial as a possible
path forward.

 Protocol design is ongoing, but in general would
involve approximately 450 HeartMate 3 LVAD patients randomized to either tecarfarin or warfarin, with dose adjustments driven by a central
committee (as in previous studies). Clinical events could include death and major non-fatal or non-surgical hemocompatibility-related
adverse events (i.e., stroke, pump thrombosis, major bleeding, or peripheral arterial thromboembolism), similar to what was used for the
original HeartMate 3 approval, and a non-inferiority margin of approximately 10%.

 To facilitate further discussion, the FDA has
requested that we submit a full study design synopsis along with adequate detail pertaining to key design features for FDA review of the
IND.

 Other Potential Pivotal Phase 3 Trials
being considered

 In 2019, the FDA provided input on the Phase 3 trial design for tecarfarin,
which was originally submitted by Espero BioPharma, Inc. ("Espero"), the previous IND sponsor of tecarfarin, evaluating the
use of tecarfarin in ESKD patients with AFib. ODD for the use of tecarfarin in this clinical circumstance was also received in 2019. We
are still evaluating whether to proceed with this indication, or whether other circumstances where tecarfarin may provide substantial
advantages over warfarin (such as ESKD in patients with mechanical heart valves or in patients with underlying pro-thrombotic disorders)
may have higher priority.

 Our cash and the proceeds from our public and
private offerings that we consummated will only fund our operations for a limited time. The proceeds from our financings to date are insufficient
to allow us to fully fund our planned pivotal Phase 3 clinical trial in LVAD patients. We will not commence a trial unless we have sufficient
funds to complete such trial and therefore, we will need to raise additional capital for the initiation of enrollment of patients and
completion of any planned pivotal Phase 3 trial. There can be no assurance that we will raise sufficient funds to support the planned
Phase 3 trial or that the trial design will be accepted by the FDA.

 Manufacturing

 We do not have a manufacturing infrastructure
and do not intend to develop one. With respect to tecarfarin, we have executed contracts with third-party contract pharmaceutical
manufacturers for the development of validated processes and the supply of active pharmaceutical ingredients and clinical trial material
in accordance with current good manufacturing practices. Such contract manufacturers have the capability to scale up for commercial
production of tecarfarin. However, we have not entered into any long-term supply agreements or commercialization partnerships with
these vendors. Certain material suppliers and manufacturing sites for our product candidate are in locations outside of the U.S.

 While the materials and substances used in our
product candidate are manufactured by more than one supplier, the number of suppliers is limited. In the event it is necessary or advisable
to acquire drug materials, substances, and products from alternative suppliers, we might not be able to obtain them on commercially reasonable
terms, if at all. It could also require significant time and expense to transfer or redesign our manufacturing processes to work with
another company. If approved by the FDA, we anticipate that we will be able to enter into agreements with third parties to manufacture
and distribute tecarfarin on commercially reasonable terms.

 Sales and Marketing

 If any of our product candidates are approved by the FDA or other regulatory
authorities, we intend to commercialize our products by hiring and training a small and dedicated salesforce to commercialize our products
in the U.S., and possibly other major markets. In addition, we anticipate entering into a variety of distribution agreements and commercial
partnerships in those territories where we do not establish an internal sales force, including if we expand outside of the U.S. We
expect that our specialized commercial cardiovascular team would be comprised of experienced marketing and sales management professionals.

 Competition

 The development and commercialization of new drugs is highly competitive.
We face competition with respect to developing our current product candidate, and we will face competition with respect to any products
that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and
biotechnology companies worldwide. We are seeking to develop tecarfarin as a marketable VKA, once-daily oral anticoagulant for chronic
anticoagulation, primarily intended for use in circumstances where warfarin may still be regarded as the standard of care, but with persistent
unmet medical needs that are inadequately addressed by current alternative anticoagulants. If we succeed in developing our planned indications
or additional indications, we will face substantial competition, primarily warfarin as the most widely used VKA. Anticoagulant treatments
for thrombosis include DOACs such as Pradaxa (dabigatran), Xarelto (rivaroxaban), Eliquis (apixaban) and Savaysa (edoxaban) for specific
indications. Warfarin is generic and manufactured by multiple generic pharmaceutical companies.

 Many of these named products are marketed by some of the largest and
most successful pharmaceutical companies worldwide, including generic pharmaceutical companies. The companies that market these products
have substantially more resources than we do and substantially more experience developing and marketing pharmaceuticals. We may not be
able to successfully compete with these existing products. Potential competitors also include academic institutions, government agencies
and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements
for research, development, manufacturing and commercialization of competing drugs and potentially competing drugs. Our competitors are
developing or may be attempting to develop therapeutics for our target indications.

 Factors affecting competition in these markets
include the financial, research and development, testing, and marketing strengths of individual competitors, trends in industry consolidation,
consumers' product options, product quality, price, technology, reputation, customer service capabilities and access to market partners
and customers. Eliquis is manufactured and distributed by Bristol Myers Squibb, Pradaxa is manufactured and distributed by Boehringer
Ingelheim, Xarelto is manufactured and distributed by Janssen Pharmaceuticals, and Savaysa is manufactured and distributed by Daiichi
Sankyo. Each of these organizations has a long operating history, extensive resources, strong brand recognition and large customer base.
As a result, we expect they will be able to devote greater resources than we can to the manufacture, promotion and sale of their products,
receive greater resources and support than we will from market partners and independent distributors, initiate and withstand substantial
price competition, and take advantage more readily than we could of acquisition and other strategic market opportunities. In addition,
these or other organizations could succeed in developing new products that perform better or more cost-effectively than our products
and product candidates in their respective markets. Moreover, changes in health trends, diet or other factors could substantially reduce
the commercial attractiveness or viability of anti-anginal, anticoagulant, anti-arrhythmic and anti-platelet products.

 The high level of competition in these markets and current or future
generic DOAC entrants could result in pricing pressure, reduced margins, the inability of our product candidates to achieve market acceptance
and other impediments to commercial success. As a result, there can be no assurance that we will be able to complete the development of
competitive products and commercialize them on a competitive basis.

 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.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with
large and established companies. These companies 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.

 Intellectual Property

 Our success will significantly depend upon our ability to obtain and
maintain patent and other intellectual property and proprietary protection for our drug candidates, including market and data exclusivity
granted by regulatory agencies and composition of matter, dosage, method of use, and formulation patents, as well as patent and other
intellectual property and proprietary protection for our novel discoveries and other important inventions and know-how. In addition to
patents, we rely upon unpatented trade secrets, know-how, and continuing technological innovation to develop and maintain our competitive
position. We protect our proprietary information, in part, using confidentiality agreements with our commercial partners, collaborators,
employees and consultants and invention assignment agreements with our employees. We also have confidentiality agreements or invention
assignment agreements with our commercial partners and selected consultants. Despite these measures, any of our intellectual property
and proprietary rights could be challenged, invalidated, circumvented, infringed, or misappropriated, or such intellectual property and
proprietary rights may not be sufficient to permit us to take advantage of current market trends or otherwise to provide competitive advantages.
For more information, please see "Risk Factors — Risks Related to Our Intellectual Property."

 We have filed an international patent application for the use of tecarfarin
in patients having undergone implantation of a cardiac device. The two issued U. S. patents, for both composition of matter and method
of treatment, expired on April 8, 2024. Foreign patents directed to tecarfarin, for composition of matter and use, expire in April
2025. In the absence of (i) future ODD marketing exclusivity granted by the FDA, (ii) future market and data exclusivity granted by regulatory
agencies and (iii) additional patent filings covering new inventions, upon expiration of our issued patents, we would not be able to adequately
protect our intellectual property, and competitors would be able to erode or negate any competitive advantage we may have, which could
harm our business and ability to achieve profitability.

 However, in the United States, the term of a patent covering an FDA-approved drug
may be eligible for a patent term extension under the Hatch-Waxman Act as compensation for the loss of patent term during the FDA
regulatory review process. The period of extension may be up to five years beyond the expiration of the patent but cannot extend
the remaining term of a patent beyond a total of fourteen years from the date of product approval. Only one patent among those eligible
for an extension may be extended. For patents that might expire during the application phase, the patent owner may request an interim
patent extension. An interim patent extension increases the patent term by one year and may be renewed up to four times. For each interim
patent extension granted, the post-approval patent extension is reduced by one year. The director of the United States Patent
and Trademark Office must determine that approval of the drug covered by the patent for which a patent extension is being sought is likely.
Interim patent extensions are not available for a drug for which an NDA has not been submitted. Provisions are available in certain other
jurisdictions to extend the term of a patent that covers an approved drug or to provide data exclusivity. For example, data exclusivity
in the EU may be available for ten years from approval and in Japan for eight years from approval. It is possible that issued
U.S. patents covering tecarfarin may be entitled to patent term extensions. If our product candidate receives FDA approval, we intend
to apply for patent term extensions, if available, to extend the term of patents that cover the approved product candidates. We also intend
to seek patent term extensions in any jurisdictions where they are available; however, there is no guarantee that the applicable authorities,
including the FDA, will agree with our assessment of whether such extensions should be granted, and even if granted, the length of such
extensions.

 Data Exclusivity

 If tecarfarin is approved by the FDA, we expect to receive five years
of data exclusivity, often referred to as new chemical entity exclusivity, for our tecarfarin NDA, so long as FDA has not approved a drug
containing the same active moiety as tecarfarin. It is possible that the FDA may disagree with our position and not approve tecarfarin
or grant new chemical exclusivity to our NDA for tecarfarin. Assuming the FDA approves tecarfarin and new chemical entity exclusivity
is granted, during the five-year period, no generic applicant can file an abbreviated new drug application ("ANDA") referencing
our NDA for tecarfarin, unless the generic applicant challenges a patent listed in the FDA Orange Book for the referenced NDA, in which
case the generic applicant can file after four years. If the patent is asserted against the generic applicant within 45 days of receipt
of a required notice letter by the generic applicant, the generic ANDA cannot be approved by FDA for up to thirty months.

 Government Regulation

 The process of obtaining regulatory approvals
and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial
time and financial resources. Failure to comply with the applicable requirements at any time during the product development process, approval
process or after approval, may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA's
refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning or untitled letters, product recalls or withdrawals
from the market, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government
contracts, restitution, disgorgement, or civil or criminal penalties.

 Product development and marketing activities are
subject to extensive regulation by various government authorities, including the FDA, other federal, state and local agencies and comparable
regulatory authorities in other countries, which regulate the design, research, clinical and non-clinical development, testing, manufacturing,
storage, distribution, import, export, labeling, advertising and marketing of pharmaceutical products and devices. Generally, before a
new drug can be sold, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific
to each regulatory authority, submitted for review and approved by the regulatory authority. The data are often generated in two distinct
development states: pre-clinical and clinical.

 Among other matters, U.S. and foreign anti-corruption,
anti-money laundering, export control, sanctions, and other trade laws and regulations, which are collectively referred to as Trade
Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors,
and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper
payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial
criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud
litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government
agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities to
increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations,
and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners,
even if we do not explicitly authorize or have prior knowledge of such activities.

 Development of Drugs in the United States

 Pharmaceutical products must be approved by the FDA before they may
be legally marketed in the United States. Pharmaceutical product development for a new product or certain changes to an approved
product in the U.S. typically involves pre-clinical laboratory and animal tests, the submission to the FDA of an investigational
new drug, or IND, application, which must become effective before clinical testing may commence, and adequate and well-controlled clinical
trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA
pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the
type, complexity and novelty of the product or disease.

 The pre-clinical development stage generally
involves synthesizing the active component, developing the formulation and determining the manufacturing process, as well as carrying
out non-human toxicology, pharmacology and drug metabolism trials that support subsequent clinical testing. These pre-clinical laboratory
and animal tests must comply with federal regulations and requirements, including the FDA's good laboratory practices regulations.
A drug's sponsor must submit the result of the pre-clinical tests, together with manufacturing information, analytical data
and any available clinical data or literature and a proposed clinical protocol to the FDA as part of an IND application. A 30-day waiting
period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented
on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

 Clinical trials involve the administration of
the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must
be conducted (i) in compliance with federal regulations, including good clinical practices, or GCPs, an international standard meant
to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors; and (ii) under
protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be
evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part
of the IND.

 Clinical trials to support NDAs for marketing
approval can generally be divided into three sequential phases that may overlap, Phase 1, Phase 2 and Phase 3 clinical
trials. In Phase 1, generally, small numbers of healthy volunteers are initially exposed to single escalating doses and then multiple
escalating doses of the product candidate. The primary purpose of these trials is to assess the metabolism, pharmacologic action and general
safety of the drug. Phase 2 trials typically involve trials in disease-affected patients to determine the dose required to produce
the desired benefits, common short-term side effects and risks. Phase 2 trials are typically well-controlled, closely monitored,
and conducted in a relatively small number of patients, usually involving no more than several hundred patients. Phase 3 trials are
intended to gather the additional information about effectiveness and safety in a larger number of patients, typically at geographically
dispersed clinical trial sites, that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate
basis for physician labeling. Phase 3 trials usually include from several hundred to several thousand patients and are closely controlled
and monitored. In many cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy
of the drug. A single Phase 3 trial with other confirmatory evidence may be sufficient in some instances. In addition to these Phase 1-3 trials,
other trials may be conducted to gather additional safety, pharmacokinetic and pharmacodynamic information. Pharmaceutical products with
active ingredients that are the same as or similar to those already approved by the FDA may have more streamlined development programs
than new chemical entities.

 The FDA may order the temporary, or permanent,
discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being
conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. Trials must be conducted
in accordance with GCPs and reporting of study progress and any adverse experiences is required. The study protocol and informed consent
information for patients in clinical trials must also be submitted to an institutional review board, or IRB, responsible for overseeing
trials at particular sites and protecting human research trial patients. An independent institutional review board may also suspend or
terminate a trial once initiated, for failure to comply with the IRB's requirements, or may impose other conditions. Accordingly,
we cannot be sure that submission of an IND, will result in the FDA allowing clinical trials to begin, or that once begun, issues will
not arise that could cause the trial to be suspended or terminated.

 Post-approval trials, sometimes referred
to as Phase 4 clinical trials, may be conducted after initial marketing approval. Sometimes, these trials are used to gain additional
experience from the treatment of patients in the intended therapeutic condition. In certain instances, the FDA may mandate the performance
of Phase 4 trials. In other situations, post-approval trials aim to gain additional indications for a medication.

 Changes to some of the conditions established
in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and
FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires
clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements
as it does in reviewing NDAs.

 Review and Approval in the United States

 Following Phase 3 trial completion, data
are analyzed to determine safety and efficacy, with any final such determination to be made by the FDA. Data are then submitted to
the FDA in an NDA, along with proposed labeling for the product and information about the manufacturing and testing processes and facilities
that will be used to ensure product quality. The cost of preparing and submitting an NDA is substantial. Manufacturers may be assessed
up to five program fees for a fiscal year for prescription drug products identified in a single approved NDA. These fees are typically
increased annually. In the United States, FDA approval of an NDA must be obtained before marketing a new drug.

 The FDA has 60 days from its receipt of an
NDA to determine whether the application will be accepted for filing based on the agency's threshold determination that the application
is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review.
The FDA has agreed to certain performance goals in the review of NDAs. Most applications for standard review drug products are reviewed
within 10 to 12 months; most applications for priority review drugs are reviewed in six to eight months. Priority review can
be applied to drugs that the FDA determines offer major advances in treatment, or provide a treatment where no adequate therapy exists.
The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain
late-submitted information, or information intended to clarify information already provided in the submission.

 The FDA may also refer applications for novel
drug products, or drug products that 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. The FDA is not bound by the recommendations of advisory committees, but it generally follows such recommendations.
Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the
FDA will inspect the facility or the facilities at which the drug is manufactured.

 The FDA may conduct a pre-approval inspection of the manufacturing
facilities for the new product to determine whether they comply with current good manufacturing practice requirements. The FDA will not
approve the product unless compliance with current good manufacturing practices, or cGMPs, is satisfactory and the NDA contains data that
provide substantial evidence that the drug is safe and effective in the indication studied.

 After the FDA evaluates the NDA and the manufacturing
facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies
in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application.
If, or when, those deficiencies have been addressed to the FDA's satisfaction in a resubmission of the NDA, the FDA will issue an
approval letter. The FDA has committed to reviewing such resubmissions in two to six months depending on the type of information
included.

 An approval letter authorizes commercial marketing
of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk
evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include
medication guides, communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU can include,
but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances,
special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability
of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug's
safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems
are identified following initial marketing.

 Pediatric Information

 Under the Pediatric Research Equity Act, or PREA,
NDAs or supplements to NDAs must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant
pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective.
The FDA may grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by regulation, PREA does not
apply to any drug for an indication for which orphan designation has been granted.

 The Best Pharmaceuticals for Children Act, or
BPCA, provides NDA holders a six-month extension of any exclusivity — patent or non-patent — for
a drug if certain conditions are met. Conditions for exclusivity include the FDA's determination that information relating to the
use of a new drug in the pediatric population may produce health benefits in that population, the FDA's written request for pediatric
studies, and the applicant's agreeing to perform, and reporting on, the requested studies within the statutory timeframe. Applications
under the BPCA are treated as priority applications, with all of the benefits that designation confers.

 Orphan Drug Designation

 Under the Orphan Drug Act, the FDA may grant orphan
drug designation to a drug 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. Orphan product 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 product designation does not convey any advantage in or shorten the duration of regulatory review and approval process.
It also does not suggest FDA approval or exclusivity. The first NDA applicant to receive FDA approval for a particular active ingredient
to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for
that product, for that indication. In addition to the potential period of exclusivity, orphan designation makes a company eligible for
grant funding of up to $500,000 per year for four years to defray costs of clinical trial expenses, tax credits for clinical research
expenses and potential exemption from the FDA application user fee.

 Orphan drug exclusivity means the FDA may not
approve any other applications to market the same drug for the same indication for seven years, except in limited circumstances,
such as (i) the drug's orphan designation is revoked; (ii) its marketing approval is withdrawn; (iii) the orphan
exclusivity holder consents to the approval of another applicant's product; (iv) the orphan exclusivity holder is unable to
assure the availability of a sufficient quantity of drug; or (v) a showing of clinical superiority to the product with orphan exclusivity
by a competitor product. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition,
or the same drug for a different disease or condition. If a drug designated as an orphan product receives marketing approval for an indication
broader than what is designated, it may not be entitled to orphan drug exclusivity. There has been recent litigation concerning FDA's
interpretation of the orphan drug exclusivity provisions.

 Accelerated Approval

 There are a variety of pathways under which applicants may seek expedited
approval from FDA, including Fast Track, breakthrough therapy, priority review and accelerated approval. Fast Track is a process designed
to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's
development plan, including the design of the proposed clinical trials, use of biomarkers and the extent of data needed to support approval.
Drugs with Fast Track designation may also qualify for accelerated approval and priority review of NDAs if relevant criteria are met.
However, Fast Track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging
in the clinical trial process.

 The FDA accelerated approval program provides
for early approval of drugs based on a drug on a clinical trial(s) showing that the drug meets a surrogate or an intermediate clinical
endpoint rather than a clinical benefit endpoint. Accelerated approval is possible for drugs for serious conditions that fill an unmet
medical need. Under priority review, the FDA reviews an application in six months rather than ten months after it is accepted for filing.

 A surrogate endpoint used for accelerated approval
is a marker, such as a laboratory measurement, that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.
Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is considered reasonably likely to predict the clinical
benefit of a drug, such as an effect on irreversible morbidity and mortality. Because it sometimes can take many years for a drug
trial to show a clinical benefit, the use of a surrogate endpoint or an intermediate clinical endpoint can significantly shorten the time
required to complete clinical trials and obtain FDA approval.

 If a drug receives accelerated approval, the company that sponsored
the application must conduct a post-approval trial to confirm the anticipated clinical benefit. These trials are known as Phase 4
or post-approval confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the
FDA grants traditional approval for the drug. Failure to conduct required post-approval studies, or confirm a clinical benefit during
post-marketing studies, will allow the FDA to withdraw the drug from the market on an expedited basis. All promotional materials
for drug candidates approved under accelerated regulations are subject to prior review by the FDA. If the confirmatory trial does
not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the
market.

 Drug Development in Europe

 In the European Union, our future products may
also be subject to extensive regulatory requirements. Similar to the United States, the marketing of medicinal products is subject
to the granting of marketing authorizations by regulatory agencies. Also, as in the United States, the various phases of pre-clinical and
clinical research in the European Union are subject to significant regulatory controls.

 Review and Approval in the European Union

 In the European Union, approval of new medicinal
products can be obtained through one of three processes: the mutual recognition procedure, the centralized procedure and the decentralized
procedure. We intend to determine which process we will follow, if any, in the future.

 Mutual Recognition Procedure: An applicant
submits an application in one European Union member state, known as the reference member state. Once the reference member state has granted
the marketing authorization, the applicant may choose to submit applications in other concerned member states, requesting them to mutually
recognize the marketing authorizations already granted. Under this mutual recognition process, authorities in other concerned member states
have 55 days to raise objections, which must then be resolved by discussion among the concerned member states, the reference member
state and the applicant within 90 days of the commencement of the mutual recognition procedure. If any disagreement remains, all
considerations by authorities in the concerned member states are suspended and the disagreement is resolved through an arbitration process.
The mutual recognition procedure results in separate national marketing authorizations in the reference member state.

 Centralized Procedure: This procedure is
currently mandatory for products developed by means of a biotechnological process and optional for new active substances and other "innovative
medicinal products with novel characteristics." Under this procedure, an application is submitted to the European Agency for the
Evaluation of Medical Products. Two European Union member states are appointed to conduct an initial evaluation of each application. These
countries each prepare an assessment report that is then used as the basis of a scientific opinion of the Committee on Proprietary Medical
Products. If this opinion is favorable, it is sent to the European Commission, which drafts a decision. After consulting with the member
states, the European Commission adopts a decision and grants a marketing authorization, which is valid throughout the European Union and
confers the same rights and obligations in each of the member states as a marketing authorization granted by that member state.

 Decentralized Procedure: The most recently
introduced of the three processes for obtaining approval of new medicinal processes in the European Union, the decentralized procedure
is similar to the mutual recognition procedure described above, but with differences in the timing that key documents are provided to
concerned member states by the reference member state, the overall timing of the procedure and the possibility of, among other things,
"clock stops" during the procedure.

 Post-Marketing Requirements

 Following approval of a new product, a pharmaceutical
company and the approved product are subject to continuing regulation by the FDA and other regulatory authorities, including, among other
things, monitoring and recordkeeping activities, reporting to applicable regulatory authorities of adverse experiences with the product,
providing the regulatory authorities with updated safety and efficacy information, product sampling and distribution requirements, and
complying with promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising,
restrictions on promoting drugs for uses or in patient populations not described in the drug's approved labeling (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, drugs may be marketed only for the approved indications and in accordance with the provisions of the approved
labeling. Modifications or enhancements to the products or labeling or changes of site of manufacture are often subject to the approval
of the FDA and other regulators, which may or may not be received or may result in a lengthy review process. The FDA regulations require
the products be manufactured in specific approved facilities and in accordance with current good manufacturing practices, and NDA holders
must list their products and register their manufacturing establishments with the FDA. These regulations also impose certain organizational,
procedural and documentation requirements with respect to manufacturing and quality assurance activities. Drug manufacturers and other
entities involved in the manufacture and distribution of approved drugs are subject to periodic unannounced inspections by the FDA and
certain state agencies for compliance with current good manufacturing practice and other laws. NDA holders using contract manufacturers,
laboratories or packagers are responsible for the selection and monitoring of qualified firms. These firms are subject to inspections
by the FDA at any time, and the discovery of violative conditions could result in enforcement actions that interrupt the operation of
any such facilities or the ability to distribute products manufactured, processed or tested by them.

 Other Regulatory Matters

 Manufacturing, sales, promotion and other activities
following product approval are also subject to regulation by numerous regulatory authorities in addition to the FDA, including, in the
United States, the Centers for Medicare & Medicaid Services, or CMS, other divisions of the Department of Health and Human
Services, 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. These laws and regulations
include:

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

 Federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other government reimbursement programs that are false or fraudulent. The government may assert that a claim including items or services resulting from a violation of the federal healthcare program anti-kickback law or related to off-label promotion constitutes a false or fraudulent claim for purposes of the federal false claims laws;

 The Federal Physician Payments Sunshine Act within the Affordable Care Act, or the ACA, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report on an annual basis information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and certain ownership and investment interests held by physicians and their immediate family members, with the information made publicly available on a searchable website; and

 The Health Insurance Portability and Accountability Act, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA's privacy and security standards directly applicable to "business associates" — independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions.

 Applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act.

 The Lanham Act and federal antitrust laws.

 State law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. In addition, several states now require prescription drug companies to report expenses relating to the marketing and promotion of drug products and to report gifts and payments to individual physicians in these states. Other states prohibit various other marketing-related activities, and still other states require the posting of information relating to clinical studies and their outcomes. In addition, California, Connecticut, Massachusetts and Nevada require pharmaceutical companies to implement compliance programs and/or marketing codes. Several additional states are considering similar proposals. Compliance with these laws is difficult and time consuming, and companies that do not comply with these state laws face civil penalties.

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

 Third-Party Payer Coverage and Reimbursement

 Significant uncertainty exists as to the coverage
and reimbursement status of any of our drug candidates that ultimately may obtain regulatory approval. In both the United States
and foreign markets, our ability to commercialize our product candidates successfully, and to attract commercialization partners for
our product candidates, depends in significant part on the availability of adequate financial coverage and reimbursement from third-party payers,
including, in the United States, governmental payers such as the Medicare and Medicaid programs, managed care organizations, and
private health insurers. Medicare is a federally funded program managed by the CMS, through local fiscal intermediaries and carriers
that administer coverage and reimbursement for certain healthcare items and services furnished to the elderly and disabled. Medicaid
is an insurance program for certain categories of patients whose income and assets fall below state defined levels and who are otherwise
uninsured that is both federally and state funded and managed by each state. The federal government sets general guidelines for Medicaid
and each state creates specific regulations that govern its individual program. Each payer has its own process and standards for determining
whether it will cover and reimburse a procedure or particular product. Private payers often rely on the lead of the governmental payers
in rendering coverage and reimbursement determinations. Therefore, achieving favorable CMS coverage and reimbursement is usually a significant
gating issue for successful introduction of a new product. The competitive position of some of our products will depend, in part, upon
the extent of coverage and adequate reimbursement for such products and for the procedures in which such products are used. Prices at
which we or our customers seek reimbursement for our products can be subject to challenge, reduction or denial by the government and
other payers.

 The pharmaceutical industry has been and continues
to be affected by federal and state legislation that alters the pricing, coverage, and reimbursement landscape. The United States
Congress and state legislatures may, from time to time, propose and adopt initiatives aimed at cost containment, which could impact our
ability to sell our products and product candidates profitably. For example, in the first quarter of 2018, President Trump signed a law
requiring pharmaceutical companies to pay for a substantially larger percentage of the coverage gap, or the so-called "donut hole,"
between regular and catastrophic Medicare Part D prescription drug coverage, a change that is estimated to have a multi-billion-dollar effect
on brand-name drug companies. Additional changes could be made in the future to governmental healthcare programs and many other
laws that could significantly impact the success of our products.

 Additionally, in August 2022, President Biden
signed into law the Inflation Reduction Act (IRA), which includes provisions that effectively authorize the government to establish prices
for certain high-spend single-source drugs and biologics reimbursed by the Medicare program, starting in 2026 for Medicare Part D drugs
and 2028 for Medicare Part B drugs. It is not yet certain which products the federal government will select and subject to government-established
prices, or how the federal government will establish prices for selected products, as the IRA specifies a ceiling price but not a minimum
price. One or more of our product candidates, if approved, could be selected and subject to the government-established price.

 The IRA also contains provisions that impose
rebates if certain prices increase at a rate that outpaces the rate of inflation, beginning October 1, 2022, for Medicare Part D drugs
and January 1, 2023, for Medicare Part B drugs. Separate IRA provisions redesign the Medicare Part D benefit in various ways, including
by shifting a greater portion of costs to manufacturers within certain coverage phases and replacing the Part D coverage gap discount
program with a new manufacturer discounting program. Failure to comply with IRA provisions may subject manufacturers to various penalties,
including civil monetary penalties. The impact of the IRA on our business and the broader pharmaceutical industry remains uncertain,
as the federal government has yet to make various IRA implementation decisions.

 The cost of pharmaceuticals continues to generate
substantial governmental and third-party payer interest. We expect that the pharmaceutical industry will experience pricing pressures
due to the trend toward managed healthcare, the increasing influence of managed care organizations and additional legislative proposals.
Our results of operations could be adversely affected by current and future healthcare reforms.

 Some third-party payers also require pre-approval of
coverage for new or innovative devices or drugs before they will reimburse healthcare providers that use such drugs. While we cannot
predict whether any proposed cost-containment measures will be adopted or otherwise implemented in the future, the announcement
or adoption of these proposals could have a material adverse effect on our ability to obtain adequate prices for our products and product
candidates and operate profitably.

 In addition, in some foreign countries, the proposed
pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing 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 tend to be significantly
lower.

 Trade Laws

 Among other matters, U.S. and foreign anti-corruption,
anti-money laundering, export control, sanctions, and other trade laws and regulations, which are collectively referred to as Trade
Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors,
and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper
payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial
criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and
fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of
government agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities
to increase in time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations,
and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners,
even if we do not explicitly authorize or have prior knowledge of such activities.

 Human Capital Employees

 As of March 13, 2025, we had four employees,
all of which are full-time, and engage approximately thirty-five consultants and contractors. Our employees are not represented by labor
unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.

 Corporate Information

 We were incorporated as a Delaware corporation
in January 2022. Our principal executive offices are located at 822 A1A North, Suite 306, Ponte Vedra, Florida 32082, and our telephone
number is (904) 300-0701. Our website address is www.cadrenal.com. The information contained on, or that can be accessed
through, our website is not incorporated by reference into this Annual Report, and you should not consider any information contained
on, or that can be accessed through, our website as part of this Annual Report or in deciding whether to purchase our Common Stock.

 Facilities

 Our corporate headquarters are located at 822
A1A North, Suite 306, Ponte Vedra, Florida 32082, which are leased pursuant to an amended Lease Agreement dated October 21, 2024
with Veranda III Partners, Ltd. (the "Lease Agreement"). The Lease Agreement has a term of 12 months commencing on November 1,
2024. The monthly rent is $2,274. We believe that these headquarters are adequate for our current operations and needs.

 Legal Proceedings

 We are not currently a party to any material
legal proceedings. We may, however, in the ordinary course of business face various claims brought by third parties, and we may, from
time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating
to employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation. If this
were to happen, the payment of any such awards could have a material adverse effect on our business, financial condition and results
of operations. Additionally, any such claims, whether or not successful, could damage our reputation and business.

 Available Information

 Our website address is www.cadrenal.com. We
will file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements and other materials
with the U.S. Securities and Exchange Commission (the "SEC"). We are subject to the informational requirements of the Exchange
Act and will file or furnish reports, proxy statements and other information with the SEC. Such reports and other information filed by
the Company with the SEC are available free of charge on our website at  filings. Information contained
on, or that can be accessed through, our website is not incorporated by reference into this Annual Report, and you should not consider
information on our website to be part of this Annual Report.

 The SEC also maintains a website that contains
reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.

 Implications of Being an Emerging Growth Company
and a Smaller Reporting Company

 We qualify as an "emerging growth company"
as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. For as long as we remain an emerging growth company,
we may take advantage of specified reduced reporting requirements and other burdens that are otherwise applicable generally to other
public companies. These provisions include, but are not limited to:

 Reduced
 obligations with respect to financial data, including presenting only two years of audited
 financial statements and selected financial data, and only two years of related Management's
 Discussion and Analysis of Financial Condition and Results of Operations disclosure in our
 initial registration statement;

 an
 exemption from the auditor attestation requirement in the assessment of our internal control
 over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended;

 reduced
 disclosure about executive compensation arrangements in our periodic reports, registration
 statements and proxy statements; and

 exemptions
 from the requirements to seek non-binding advisory votes on executive compensation or stockholder
 approval of any golden parachute arrangements.

 We may take advantage of some or all of these
provisions until we are no longer an emerging growth company. We will remain an emerging growth company until the earliest of (i) the
last day the fiscal year following the fifth anniversary of the completion of our initial public offering, (ii) the last day of the first
fiscal year in which our annual gross revenues exceed $1.235 billion, (iii) the date on which we have, during the immediately preceding
three-year period, issued more than $1.0 billion in non-convertible debt securities and (iv) the date on which we are deemed to be a
large accelerated filer under the rules of the SEC, or the SEC. We may choose to take advantage of some but not all of these reduced
burdens. For example, we have taken advantage of the reduced reporting requirements with respect to disclosure regarding our executive
compensation arrangements, have presented only two years of audited financial statements and only two years of related "Management's
Discussion and Analysis of Financial Condition and Results of Operations" disclosure in this Annual Report, and have taken advantage
of the exemption from auditor attestation on the effectiveness of our internal control over financial reporting. To the extent that we
take advantage of these reduced burdens, the information that we provide stockholders may be different than you might obtain from other
public companies in which you hold equity interests.

 In addition, the JOBS Act permits emerging growth
companies to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public
companies. We have elected to use this extended transition period. As a result of this election, our timeline to comply with new or revised
accounting standards will in many cases be delayed as compared to other public companies that are not eligible to take advantage of this
election or have not made this election. Therefore, our financial statements may not be comparable to those of companies that comply
with the public company effective dates for these accounting standards.

 We are also a "smaller reporting company"
as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act, and have elected to take advantage of certain of
the scaled disclosures available to smaller reporting companies. To the extent that we continue to qualify as a "smaller reporting
company" as such term is defined in Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company,
certain of the exemptions available to us as an "emerging growth company" may continue to be available to us as a "smaller
reporting company," including exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure
about our executive compensation arrangements. We will continue to be a "smaller reporting company" until we have $250 million
or more in public float (based on our Common Stock) measured as of the last business day of our most recently completed second fiscal
quarter or, in the event we have no public float (based on our Common Stock) or a public float (based on our Common Stock) that is less
than $700 million, annual revenues of $100 million or more during the most recently completed fiscal year.

 Item 1A. Risk Factors.

 Investors should carefully consider the risks
described below before deciding whether to invest in our securities. If any of the following risks actually occur, our business, financial
condition or results of operations could be adversely affected. In such case, the trading price of our Common Stock could decline and
you could lose all or part of your investment. Our actual results could differ materially from those anticipated in the forward-looking
statements made throughout this Annual Report a result of different factors, including the risks we face described below.

 Risks Related to Our Financial Position and
Need for Capital

 We are a clinical development biopharmaceutical
company with a limited operating history.

 We were formed in January 2022 and have had limited
operations to date. We have to manufacture product, complete clinical trials and receive regulatory approval of NDAs before commercial sales of our product candidates can commence. The likelihood of success of our business plan must be considered
in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with building
and expanding clinical development pharmaceutical businesses and the regulatory and competitive environment in which we operate. Pharmaceutical
product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.

 Accordingly, you should consider our prospects
in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the later stage of development,
especially clinical pharmaceutical companies such as ours. Potential investors should carefully consider the risks and uncertainties
that a company with a limited operating history will face. In particular, potential investors should consider that we cannot assure you
that we will be able to:

 complete the clinical trials necessary to obtain regulatory approval for the marketing of
 our product candidate, tecarfarin;

 secure
 acceptance of our product candidate in the medical community and with third-party payors
 and consumers;

 if
 approved for commercial sale, launch commercial sales of our product candidate, whether alone
 or in collaboration with others;

 build an internal sales force meeting our requirements for the marketing and sale of our
 product candidate, tecarfarin;

 manufacture our clinical product and establish commercial drug supply;

 secure
 market exclusivity and/or adequate intellectual property protection for our product candidate;

 attract
 and retain an experienced management, board and scientific advisory team;

 implement or execute our current business plan, and we cannot assure you that our business
 plan is sound; and

 raise
 sufficient funds in the capital markets to effectuate our business plan.

 If we cannot successfully execute any one of
the foregoing, our business may not succeed and your investment will be adversely affected.

 We have a limited operating history upon
which to evaluate our ability to commercialize our product candidate.

 We are a development-stage company and our
success is dependent upon our ability to obtain regulatory approval for and commercialize our product candidate, tecarfarin, and we
have not demonstrated an ability to perform the functions necessary for the approval or successful commercialization of any product
candidate. We have yet to demonstrate our ability to overcome the risks frequently encountered in our industry and are still subject
to many of the risks common to such enterprises, including our ability to implement our business plan, market acceptance of our
proposed business and lead product, under-capitalization, cash shortages, limitations with respect to personnel, financing and other
resources, competition from better funded and experienced companies, and uncertainty of our ability to generate revenues. In fact,
though individual team members have experience running clinical trials and our Chief Executive Officer has been involved with the
development of tecarfarin for six years, as a company we have yet to prove that we can successfully run a clinical trial. There is
no assurance that our activities will be successful or will result in any revenues or profit, and the likelihood of our success must
be considered in light of the stage of our development. In addition, no assurance can be given that we will be able to consummate
our business strategy and plans, or that financial, technological, market, or other limitations may force us to modify, alter,
significantly delay, or significantly impede the implementation of such plans. We have insufficient results for investors to use to
identify historical trends. Investors should consider our prospects in light of the risk, expenses and difficulties we will
encounter as an early-stage company. Our revenue and income potential are unproven and our business model is continually evolving.
We are subject to the risks inherent to the operation of a new business enterprise, and cannot assure you that we will be able to
successfully address these risks.

 We have a history of operating losses and
expect to continue to incur substantial losses for the foreseeable future. We may never become profitable or, if achieved, be able to
sustain profitability.

 To date, we have not generated any revenue from
operations and we expect to continue to incur significant operating losses in connection with the development and sale of tecarfarin.
We may continue to incur operating losses until such time, if ever, as we are able to achieve sufficient levels of revenue from operations.
Our ability to achieve profitability will depend on regulatory approval of our product candidate and if approved, the market acceptance
of our product offering and our capacity to develop, introduce and sell our product to our targeted markets. There can be no assurance
that we will ever generate significant sales or achieve profitability. Accordingly, the extent of future losses and the time required
to achieve profitability, if ever, cannot be predicted at this point.

 Even if we succeed in developing and commercializing
one or more product candidates, we expect to incur substantial losses for the foreseeable future and may never become profitable. We
also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially
in the foreseeable future as we:

 continue
 to undertake the pivotal clinical trial for our product candidate;

 seek
 regulatory approvals for our product candidate;

 implement
 additional internal systems and infrastructure; and

 hire
 additional personnel.

 We may not be able to generate revenue or achieve
profitability in the future. Our failure to achieve or maintain profitability would likely negatively impact the value of our securities
and could prevent us from continuing as a going concern.

 Even if we can secure such arrangements, we may
continue to have obligations and expenses that exceed the revenue generated by these marketed products. In addition, we could incur significant
development and other expenses if we were to make alterations to the manufacturing process for tecarfarin, for preparation and submission
of a supplemental NDA for such alterations, if required by the FDA, and in connection with the launch of tecarfarin, if approved. Further,
as we pursue FDA approval for tecarfarin, we expect that our research and development expenses will continue to increase significantly
as we advance our pivotal Phase 3 clinical trial.

 Our cash and the proceeds from our completed
financings will only fund our operations for a limited time, and we will need to raise additional capital to fund our planned pivotal
Phase 3 clinical trial and to support our development and commercialization efforts for our product candidate, tecarfarin.

 If we do not succeed in raising additional funds
on acceptable terms, we will be unable to commence our planned Phase 3 pivotal clinical trial or obtain approval of our product candidate
from the FDA and other regulatory authorities. In addition, we could be forced to delay, discontinue or curtail product development,
forego sales and marketing efforts, and forego licensing in attractive business opportunities.

 We will also need to raise additional capital
to expand our business to meet our long-term business objectives.

 We believe that our existing cash and cash equivalents
will be sufficient in the aggregate to meet our anticipated cash requirements for at least the next twelve months. We will, however, require
additional financing as we continue to execute our business strategy, including that we will require additional funds for the initiation
of enrollment of patients and completion of the planned pivotal Phase 3 trial. Our liquidity may be negatively impacted as a result of
research and development cost increases in addition to general economic and industry factors. We anticipate that, to the extent that we
require additional liquidity, it will be funded through the incurrence of other indebtedness, additional equity financings, or a combination
of these potential sources of liquidity. In addition, we may raise additional funds to finance future cash needs through grant funding
and/or corporate collaboration and licensing arrangements. If we raise additional funds by issuing equity securities or convertible debt,
our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve
agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making
capital expenditures or declaring dividends. If we raise additional funds through collaboration and licensing arrangements with third
parties, it may be necessary to relinquish valuable rights to our products, future revenue streams or product candidates or to grant licenses
on terms that may not be favorable to us. The covenants under future credit facilities may limit our ability to obtain additional debt
financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Any failure to raise capital
in the future could have a negative impact on our financial condition and our ability to pursue our business strategies.

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

the outcome, timing, and cost of our Phase 3 clinical trial to obtain
regulatory approval for tecarfarin in the United States;

 the costs of manufacturing our clinical product and establishing commercial
drug supply;

 the
 degree and rate of market adoption of our products, if approved;

 the
 emergence of new, competing technologies and products;

 the
 costs of R&D activities we undertake to develop new products and indications;

 the
 costs of commercialization activities, including sales, marketing and manufacturing;

 the
 costs of building an internal sales force meeting our requirements for the marketing and
 sale of our product candidates, if approved;

 our
 ability to collaborate with third parties on the development and commercialization of our
 product candidates and products;

 the
 level of working capital required to support our growth; and

 our
 need for additional personnel, information technology or other operating infrastructure to
 support our growth and operations as a public company.

 Other than our at-the-market facility with H.C.
Wainwright & Co., we do not currently have any arrangements or credit facilities in place as a source of funds, and there can be no
assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all. Availability of funding from the
at-the-market facility is limited due to certain restrictions. We anticipate that the additional funding we require will be funded through
a combination of private and public equity offerings, debt financings and strategic collaborations. Debt financing, if obtained, may involve
agreements that include covenants limiting or restricting our ability to take specific actions, including issuing shares of our Common
Stock or other securities and incurring additional debt, and could increase our expenses and require that our assets secure such debt.
Equity financing, if obtained, could result in dilution to our then existing stockholders and/or require such stockholders to waive certain
rights and preferences. If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay,
scale back or eliminate the development of business opportunities and our operations and financial condition may be materially adversely
affected. We can provide no assurances that any additional sources of financing will be available to us on favorable terms, if at all.
In addition, if we are unable to secure sufficient capital to fund our operations, we might have to enter into strategic collaborations
that could require us to share commercial rights to our products or product candidates with third parties in ways that we currently do
not intend or on terms that may not be favorable to us. If we choose to pursue additional indications and/or geographies for any of our
products or product candidates or otherwise expand more rapidly than we presently anticipate, we may also need to raise additional capital
sooner than expected.

 Our need for future financing may result
in the issuance of additional securities, which will cause investors to experience dilution.

 Our cash requirements may vary from those now
planned, depending upon numerous factors, including the results of future research and development activities. We expect our expenses
to increase if and when we initiate and conduct clinical trials, and seek marketing approval for our product candidates. In
addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses
related to product sales, marketing, manufacturing and distribution. Accordingly, we will need to obtain substantial additional funding
in connection with our continuing operations. There are no other commitments by any person for future financing. Our securities may be
offered to other investors at a price lower than the price per share offered to current stockholders, or upon terms which may be deemed
more favorable than those offered to current stockholders. In addition, the issuance of securities in any future financing may dilute
an investor's equity ownership and have the effect of depressing the market price for our securities. Moreover, we may issue derivative
securities, including options and/or warrants, from time to time, to procure qualified personnel or for other business reasons. The issuance
of any such derivative securities, which is at the discretion of our board of directors, may further dilute the equity ownership of our
stockholders.

 Risks Related to Product Development, Regulatory
Approval, Manufacturing and Commercialization

 Our business is dependent upon the success
of our investigational product candidate, tecarfarin, which requires additional clinical testing before we can seek regulatory approval
and potentially launch commercial sales. We do not own any other product candidates or have any other products in clinical development.

 Our business and future success depends upon
our ability to obtain regulatory approval of and then successfully commercialize our product candidate, tecarfarin. Tecarfarin is in
late clinical stage development. Our main focus and the investment of a significant portion of our efforts and financial resources is
expected to be in the development of our only product candidate, tecarfarin, for which we are currently planning a Phase 3 clinical trial.
Even though we are pursuing a registration pathway based on specific FDA input and guidance, there are many uncertainties known and unknown
that may affect the outcome of the trial. These include adequate patient enrollment, adequate supply of our product candidate, potential
changes in the regulatory landscape, the results of the trial being successful, and FDA acceptance of the data to support approval. We
also rely on third parties to conduct the appropriate clinical trials, and their failure to perform in accordance with applicable law
would have a negative effect on our regulatory submission.

 Our future success depends heavily on our ability
to successfully manufacture, develop, obtain regulatory approval, and commercialize tecarfarin, which may never occur. We currently generate
no revenues from our product candidate, and we may never be able to develop or commercialize a marketable drug.

 All of our current data for our product
candidate are the results of clinical trials conducted by third parties and do not necessarily provide sufficient evidence that our products
are viable as potential pharmaceutical products.

 We possess toxicology, pharmacokinetic, and other
preclinical data and clinical data on tecarfarin from studies and trials conducted several years ago by third parties. As of now, tecarfarin
has been tested in eleven clinical trials and is now in preparation to enter a pivotal Phase 3 trial. There is no guarantee that Phase
1 or Phase 2 results can or will be replicated by the pivotal Phase 3 study. Further, as the clinical trials were conducted by third
parties and were completed prior to our ownership of the technology and data, we cannot be assured that such trials were conducted in
compliance with applicable statutes, rules, regulations, and guidelines applicable to such trials.

 Previous clinical trials using tecarfarin have
had different trial designs, doses, parameters and endpoints than the planned Phase 3 clinical trial that is expected to serve as a basis
for approval of tecarfarin. We intend to design the Phase 3 protocol based on input from our recent meeting with the FDA, however, there
can be no assurance that the protocol will be accepted by the FDA. We plan to use a fixed dose in future clinical trials that we believe
provides good coverage given the dose ranges tested clinically; however, it is possible that the dose selected will not be the optimal
dose and so drug effects may be limited or not be demonstrated sufficiently in clinical testing.

 As all of our clinical trials to date were
conducted by third parties, we cannot be assured that such clinical trials were in compliance with applicable laws, rules and regulations.

 We did not acquire tecarfarin until April of
2022, and do not have first-hand knowledge of how the Phase 1 and Phase 2 clinical trials were completed. As such, we cannot be assured
that such clinical trials were conducted in full compliance with applicable laws, rules and regulations. Additionally, we cannot be assured
historical data for such trials are accurate and sufficient for acceptance by the FDA. While we are not aware of any issues in relation
to such trials and the performance thereof, we cannot be assured that we may learn in the future that there was a failure to abide by
such laws, rules and regulations, which could potentially expose us to issues with regards to our Phase 3 clinical trials or otherwise
create risks unknown to us with regards to our technology.

 Our efforts to develop our product candidate
may not generate data sufficient to support an application for regulatory approval.

 Despite the global burden of cardiovascular disease,
investment in cardiovascular drug development has stagnated over the past two decades, with relative underinvestment compared with other
therapeutic areas. The reasons for this trend are multifactorial, but of primary concern is the high cost of conducting cardiovascular
outcome trials in the current regulatory environment that demands a direct assessment of risks and benefits, using clinically meaningful
cardiovascular endpoints. In addition, clinical trials are difficult to design and implement, can take many years to complete and are
uncertain as to outcome. Success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will
be successful, and interim results of a clinical trial do not necessarily predict final results. There is no guarantee that our clinical
trials will reach statistical significance on their endpoints, or demonstrate superiority to warfarin or any other therapy. A failure
of one or more of clinical trials can occur at any stage of testing. Our product candidate may prove to have undesirable or unintended
side effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial
use with respect to one or all intended indications. In addition, we may experience other numerous unforeseen events during, or as a
result of, the clinical trial process that could delay or prevent our ability to continue development. Development stage risks include
the following:

 although we have FDA minutes documenting our recent meetings with the
FDA, the FDA minutes are not binding on the FDA, and the FDA or comparable foreign regulatory authorities or institutional review boards,
or IRBs, may disagree with the design or implementation of our clinical trial and refuse to let them proceed;

 we
 may not be able to provide acceptable evidence of the safety and efficacy of our product
 candidates or an acceptable benefit/risk profile for our product candidate;

 we
 may not be able to successfully manufacture drug supplies for our clinical trial;

 the
 results of our clinical trial may not be satisfactory or may not meet the level of statistical
 or clinical significance required by the FDA, European Medicines Agency, or EMA, or other
 comparable foreign regulatory authorities to demonstrate effectiveness;

 we
 may not be able to determine the optimal dosing of our product candidates; and

 patients
 in our clinical trial may suffer adverse effects that are deemed related to our product candidates,
 leading us or regulatory authorities to stop clinical trial temporarily or permanently.

 If unacceptable safety concerns or other adverse
events arise in the development of a product candidate, our clinical trials could be suspended or terminated or the FDA or comparable
foreign regulatory authorities could order us to cease clinical trials or deny approval of such product candidate for any or all targeted
indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the
trial or result in potential product liability claims. Inadequate training in recognizing or managing the potential side effects of a
product candidate could result in patient deaths. Any of these occurrences may harm our business, financial condition and prospects significantly.

 Even if we successfully complete our clinical
trials, we may not receive regulatory approval for tecarfarin, and we may not be able to commercialize our product candidate and our
ability to generate revenue will be limited.

 The research, testing, manufacturing, labeling, packaging, storage,
approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive
regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations differ from country
to country. We are not permitted to market our product candidate in the United States until we receive approval of an NDA from the FDA
and in non-U.S. markets until we receive the requisite approval from comparable regulatory agencies in such countries. Of the large number
of drugs in development, only a small number are submitted for approval to the FDA through an NDA and even fewer are eventually approved
for commercialization. We may not succeed at gaining regulatory approval, which would materially harm our business.

 Receipt of necessary regulatory approval is subject
to a number of risks, including the following:

 the
 data collected from pre-clinical and clinical trials may not be accurate or sufficient to
 support the submission of an 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
 relevant laws, 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 cannot guarantee that regulators will agree
with our assessment of the results of our clinical trials or that such trials will be considered by regulators to have shown safety or
efficacy of our product candidates. The FDA, EMA and other regulators have substantial discretion in the approval process and may refuse
to accept any application or may decide that our data are insufficient for approval and require additional clinical trials, or pre-clinical
or other trials. In addition, varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit
or prevent regulatory approval of a product candidate. Failure to obtain regulatory marketing approval for our product candidates in
any indication will prevent us from commercializing the product candidate, and our ability to generate revenue will be materially impaired.

 The process of obtaining regulatory approvals
is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things, the
type, complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and the substantial
discretion of the regulatory authorities. Changes in regulatory review for a submitted product application may cause delays in approval
or rejection of an application. Regulatory approval obtained in one jurisdiction does not necessarily mean that a product candidate will
receive regulatory approval in all jurisdictions in which we may seek approval, but the failure to obtain approval in one jurisdiction
may negatively impact our ability to seek or gain approval in a different jurisdiction. Obtaining foreign regulatory approvals and compliance
with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the
introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or
fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential
of tecarfarin or any future product candidates will be harmed.

 Fast Track designation by the FDA may not
actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidate.

 If a product candidate is intended for the treatment
of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical need for this
condition, the sponsor may apply for FDA Fast Track designation. However, a Fast Track designation does not ensure that the product candidate
will receive marketing approval or that approval will be granted within any particular timeframe. As a result, while we have received
Fast Track designation for tecarfarin for the prevention of systemic thromboembolism of cardiac origin in patients with ESKD and AFib,
we may not experience a faster development process, review or approval 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.

 Even if we obtain regulatory approval,
we will still face ongoing regulatory requirements and tecarfarin may face future development and regulatory difficulties.

 Even if we receive regulatory approval of tecarfarin or any future
product candidates, we will be subject to ongoing regulatory obligations, such as post market surveillance and cGMP requirements, and
continued regulatory review, which may result in significant additional expense. We may also be subject to penalties if we fail to comply
with regulatory requirements or experience unanticipated problems with product candidates. In addition, third parties on whom we rely
must comply with regulatory requirements, and any non-compliance on their part may negatively impact our business, assuming we obtain
regulatory authorization at all.

 Any regulatory approvals that we receive for product candidates will
require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a Risk Evaluation and Mitigation
Strategy ("REMS") program in order to approve product candidates, which could entail requirements for a medication guide,
physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and
other risk minimization tools. The FDA could also require a boxed warning, sometimes referred to as a Black Box Warning on the product
label to identify a particular safety risk, which could affect commercial efforts to promote and sell the product. In addition, if the
FDA or a comparable foreign regulatory authority approves product candidates, the manufacturing processes, labeling, packaging, distribution,
adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for product candidates will be subject to extensive
and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports,
registration, as well as continued compliance with cGMPs and current good clinical practices ("GCPs") for any clinical trials
that we conduct post-approval. We are also subject to certain user fees imposed by the regulatory agencies. Later discovery of previously
unknown problems with product candidates, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers
or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

 import
 alerts or automatic detentions;

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

 fines,
 warning letters or holds on clinical trials;

 refusal
 by the FDA to approve pending applications or supplements to approved applications filed
 by us or suspension or revocation of approvals;

 labeling
 changes;

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

 injunctions
 or the imposition of civil or criminal penalties; and

 inability
 to obtain government contracts.

 The FDA's and other regulatory authorities'
policies may change, such as those required by the 21 st Century Cures Act, and additional government regulations may be enacted
that could prevent, limit or delay regulatory approval of tecarfarin or any future product candidates. In addition, it is unclear what
changes, if any, the new presidential administration may bring. We cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. 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.

 Clinical trials are very expensive, time-consuming
and difficult to design and implement.

 As part of the regulatory process, we must conduct
clinical trials for each product candidate to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities.
As we advance tecarfarin or any future product candidates we expect that our expenses will increase. The number and design of the clinical
trials that will be required varies depending upon product candidate, the condition being evaluated, current medical strategies and the
trial results themselves. Therefore, it is difficult to accurately estimate the cost of the clinical trials. Clinical trials are very
expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial
process is also time consuming. We estimate that clinical trials of product candidates including tecarfarin, will take at least several
years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon
or repeat clinical trials. The commencement and completion of clinical trials may be delayed or prevented by several factors, including:

 unforeseen
 safety issues;

 failure
 to determine appropriate dosing;

 greater
 than anticipated cost of our clinical trials;

 failure
 to demonstrate effectiveness during clinical trials;

 slower
 than expected rates of subject recruitment or difficulty obtaining investigators, particularly
 during COVID-19;

 subject
 drop-out or discontinuation;

 import
 delays of clinical trial materials;

 inability
 to monitor subjects adequately during or after treatment;

 third
 party contractors, including, without limitation, CROs and manufacturers, failing to comply
 with regulatory requirements or meet their contractual obligations to us in a timely manner

 reaching
 agreements with prospective CROs, and trial sites, both of which can be subject to extensive
 negotiation and may vary significantly among different CROs and trial sites;

 insufficient
 or inadequate supply or quality of product candidates or other necessary materials to conduct
 our trials;

 potential
 additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory
 authorities regarding the scope or design of our clinical trials, or other studies requested
 by regulatory agencies;

 problems
 engaging Institutional Review Boards ("IRBs"), to oversee trials or in obtaining
 and maintaining IRB approval of studies;

 imposition
 of clinical hold or suspension of our clinical trials by regulatory authorities; and

 inability
 or unwillingness of medical investigators to follow our clinical protocols.

 In addition, we or the FDA may suspend or terminate
our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies
in our Investigational New Drug, or IND, submissions or the conduct of these trials. Therefore, we cannot predict with any certainty
when, if ever, future clinical trials will commence or be completed.

 Delays in the enrollment of patients in
any or all of our clinical trials could increase our development costs and delay completion of our clinical trials and associated regulatory
submissions.

 We may not be able to initiate or continue clinical trials for our
product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required
by the FDA or other regulatory authorities. A pandemic or epidemic would likely make this even more challenging. Even if we are able to
enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs
for our product candidates may increase, and the completion of our trials may be delayed or our trials could become too expensive to complete.

 Even if approved, tecarfarin may not have
labeling that allows us to successfully commercialize it.

 The commercial success of tecarfarin and any
of our future product candidates will depend in significant measure upon our ability to obtain approval from the FDA and other regulatory
authorities of labeling describing a product candidate's expected features or benefits. Regulatory authorities may approve tecarfarin
for fewer or more limited indications than we request or may approve tecarfarin with labeling that does not include the labeling claims
necessary or desirable for the successful commercialization of that indication. Failure to achieve approval from the FDA or other regulatory
authorities of product labeling containing certain types of information on features or benefits of our products will prevent or substantially
limit our advertising and promotion of such features in order to differentiate our product candidates or any future product candidates
from those products already existing in the market. This may make it difficult or impossible to achieve commercial success.

 If our product candidate is approved, our
success depends on our commercialization efforts, which may not be achieved. If we are unable to commercialize our product candidate,
or experience significant delays in doing so, our business could be materially harmed.

 We will invest a significant portion of our efforts
and financial resources into the development and commercialization of tecarfarin. Product revenues from our product candidate, tecarfarin,
which will not be realized until after regulatory approval, if ever, will depend on the successful development, regulatory approval and
eventual commercialization of these product candidates. The success of our product candidate will depend on several factors, including
the following:

 receipt
 of marketing approvals for our product candidate from the FDA and similar regulatory authorities
 outside the United States;

 obtaining
 product indications, other labeling information and product attributes that are acceptable
 and attractive to the medical community, third-party payors and patients;

 our
 ability to manufacture product commercially at acceptable costs;

 establishing
 and maintaining commercial manufacturing arrangements with third parties;

 commercializing our product candidate, if approved, whether alone or in collaboration with
 others;

 a
 continued acceptable safety profile of the product candidate following approval; and

 obtaining,
 maintaining, enforcing and defending intellectual property rights and claims and available
 product exclusivities.

 If we do not achieve one or more of these factors
in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidate,
which would materially harm our business. In addition, even if we obtain regulatory approvals for tecarfarin, the timing or scope of
any approval may prohibit or reduce our ability to commercialize tecarfarin successfully. For example, if the approval process takes
too long, we may miss market opportunities and give other companies the ability to develop competing products or establish market dominance.
Also, any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render
tecarfarin not commercially viable. For example, regulatory authorities may grant approval contingent on the performance of costly post-marketing
clinical trials or, outside the U.S., they may not accept or approve the price we intend to charge for tecarfarin. Further, the FDA or
comparable foreign regulatory authorities may place conditions on approvals, such as risk management plans and Risk Evaluation and Mitigation
Strategies, or REMS, to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a
proposed REMS; the FDA will not approve the NDA without an approved REMS, if required. A REMS could include medication guides, physician
communication plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization
tools. The FDA may also require a REMS for an approved product when new safety information emerges. Any of these limitations on approval
or marketing could restrict the commercial promotion, distribution, prescription or dispensing of tecarfarin. Moreover, product approvals
may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the product. Any
of the foregoing scenarios could materially harm the commercial success of tecarfarin.

 Our potential future product candidate,
tecarfarin, may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical
community necessary for commercial success.

 The commercial success of any potential future
product candidates, including tecarfarin, for which we may obtain marketing approval from the FDA or other regulatory authorities will
depend upon their acceptance by the medical community and third-party payors as clinically useful, cost-effective and safe. The degree
of market acceptance of any drug depends on a number of factors, such as:

 effectively
 competing with other therapies;

 the
 prevalence and severity of any side effects;

 success
 of patients in well-controlled clinical trials compared to real-world success of patients
 post FDA approval;

 our
 ability to educate and increase physician awareness of the benefits of our products relative
 to competing drugs;

 the
 willingness of physicians and healthcare organizations to change their current treatment
 practices, especially with respect to warfarin, a drug that is dominant in the market and
 with which physicians and healthcare organizations have 60 years of familiarity;

 the
 willingness of hospitals and hospital systems to include our product candidates as treatment
 options;

 efficacy
 and potential advantages compared to alternative treatments;

 the
 price we charge for our product candidates;

 interpretations
 of the results of our clinical trials;

 the
 status of our products on the formularies of third-party payers;

 convenience
 and ease of administration compared to alternative treatments;

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

 the willingness of the
 target patient population to pay for our products, including co-pays under their health coverage plans;

 the
 accuracy of the international normalized ratio, or INR, testing and whether such testing
 can be conducted at home or in a medical facility such as a doctor's office. A prothrombin
 time, or PT, is a test used to help detect and diagnose a bleeding disorder or excessive
 clotting disorder; the INR is calculated from a PT result and is used to monitor how well
 an anticoagulant medication such as tecarfarin is working to prevent thrombosis;

 the
 strength of marketing and distribution support; and

 the
 availability of third-party coverage and adequate reimbursement.

 The failure to attain market acceptance among
the medical community, patients and third-party payors may have an adverse impact on our operations and profitability.

 We have never submitted an NDA to the FDA
or comparable applications to other regulatory authorities and we may not be successful in achieving approval of our product candidates.

 We have never submitted an NDA to the FDA or
comparable applications to other regulatory authorities and expect to rely on consultants and third-party contract research organizations,
or CROs, with expertise in this area to assist us in this process. Securing FDA approval requires the submission of pre-clinical, clinical
and/or pharmacokinetic data, information about product manufacturing processes and inspection of facilities and supporting information
to the FDA for each therapeutic indication to establish a product candidate's safety and efficacy for each indication. Regulatory
authorities in other jurisdictions impose similar requirements. If we are unable to successfully complete the approval process with the
FDA or comparable applications of other regulatory authorities, our business will not be successful.

 Orphan Drug Designation does not translate
to approval and, even if we obtain FDA approval, we may not enjoy marketing exclusivity or other expected benefits.

 Although we have been granted orphan drug designation
for tecarfarin, this does not mean FDA will approve the NDA. Even if we obtain FDA approval, we may not be able to obtain or maintain
orphan drug exclusivity for tecarfarin. We may not be the first to obtain marketing approval of tecarfarin designation for the orphan-designated
indication due to the uncertainties associated with developing pharmaceutical products. 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 product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity for
a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties
may be approved for the same condition, or the competitive product is otherwise outside the scope of exclusivity. 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 product with orphan exclusivity is unable to maintain sufficient product 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 product candidate for indications other than those
in which orphan drug designation have been granted.

 After approval of tecarfarin, tecarfarin
will remain subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional risk
and expense.

 Drug products remain subject to the jurisdiction of the FDA and non-U.S.
regulatory authorities after they have been approved. Even if we obtain regulatory approval of tecarfarin, the FDA and other regulatory
authorities may impose significant restrictions on its indicated uses or marketing or the conditions of approval, or impose ongoing requirements
for potentially costly and time-consuming post-approval trials, including Phase 4 clinical trials, and post-market surveillance to monitor
safety and efficacy. Our product candidate, if approved, as well as our marketed products are subject to ongoing regulatory requirements
governing the manufacturing, labeling, packaging, storage, distribution, safety surveillance, advertising, promotion, sampling, recordkeeping
and reporting of adverse events and other post-market information. These requirements include registration with the FDA and continued
compliance with cGMPs and current Good Clinical Practices requirements, or cGCPs, for any clinical trials that we conduct post-approval.

 After approval, our products could be subject
to labeling and other restrictions and we may be required to withdraw from the market or be subject to penalties if we fail to comply
with regulatory requirements.

 The product labeling, advertising and promotion
of our products and our product candidates, if approved, are subject to regulatory requirements and continuing regulatory review. Government
authorities, including the FDA and the Office of the Inspector General of the Department of Health and Human Services, or OIG, strictly
regulate the promotional claims and activities that may be made about prescription products. A drug product may not be promoted for uses
that are inconsistent with the product's approved labeling. If we receive marketing approval for tecarfarin, physicians may nevertheless
legally prescribe our products to their patients in a manner that is inconsistent with the approved labeling. However, if we are found
to have promoted such off-label uses, we may become subject to significant liability and government fines. The federal government has
extracted very large settlements and levied very large civil and criminal fines against companies for alleged improper promotion, has
enjoined companies from engaging in off-label promotion, and made companies agree to onerous multi-year corporate integrity agreements.
The FDA has also requested that companies enter into consent decrees of permanent injunctions under which specified promotional conduct
is changed or curtailed. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product
candidates and generate revenue. Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability
claims and increase our product liability exposure.

 We are subject, directly or indirectly,
to federal and state obligations and regulations applicable to our marketing practices. If we are unable to comply, or have not complied,
with such laws, we could face substantial penalties.

 Our marketing and sales operations are subject
to various federal and state fraud and abuse laws, including, without limitation, the federal and state anti-kickback statutes and false
claims laws. With respect to sales and marketing activities by us or any future partner, advertising and promotional materials must comply
with FDA rules in addition to other applicable federal, state and local laws in the United States and similar legal requirements in other
countries. We also are subject, directly or indirectly through our customers and partners, to various fraud and abuse laws, including,
without limitation, the U.S. Federal Healthcare Program Anti-Kickback Statute, U.S. False Claims Act, and similar state laws, which impact,
among other things, most of our interactions with customers, including our proposed sales, marketing, and scientific/educational grant
programs. We are also subject to complex laws and regulation regarding reporting and payment obligations as a result of our participation
in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule of the U.S. Department of Veterans Affairs, and other government
drug programs. All of these activities are also potentially subject to U.S. federal and state consumer protection and unfair competition
laws. Similar requirements exist in many of these areas in other countries. If investigated, we could be forced to incur substantial
expense responding to the investigation and defending our actions. If unsuccessful in our defense, we could be found to be in violation
and subject to substantial fines and penalties,

 We currently do not have any long-term
supply agreements or commercialization partnerships with third-party manufacturers for the production and distribution of tecarfarin
and intend to rely upon third parties to produce and distribute our product candidate.

 We have executed contracts with third-party pharmaceutical contract
development and manufacturing organizations ("CDMOs") for the development of validated processes and the supply of active
pharmaceutical ingredients and clinical trial material in accordance with good manufacturing practices. Such CDMOs have the capability
to scale up for commercial production of tecarfarin. However, we have not entered into any long-term supply agreements or commercialization
partnerships with these vendors. Certain material suppliers and manufacturing sites for our products and product candidates are in locations
outside of the U.S. While the materials and substances used in our product candidate are manufactured by more than one supplier, the number
of suppliers is limited. In the event it is necessary or advisable to acquire drug materials, substances, and products from alternative
suppliers, we might not be able to obtain them on commercially reasonable terms, if at all. It could also require significant time and
expense to transfer or redesign our manufacturing processes to work with another company. If approved by the FDA, we anticipate that we
will be able to enter into agreements with third parties to manufacture and distribute tecarfarin on commercially reasonable terms.

 We intend to rely on third-party CDMOs to produce
tecarfarin for our clinical studies who are expected to purchase materials from third-party vendors and transport the materials necessary
to produce tecarfarin, such as the required reagents and containers. This reliance on CDMOs and third-party vendors that we do not own
or operate exposes us to various risks, including:

 Supply Disruptions: Our CDMOs may experience difficulties in manufacturing,
including shortages of raw materials, equipment failures, capacity constraints, or regulatory enforcement actions, any of which could
result in delays or interruptions in supply.

 Regulatory Compliance Risks: Our CDMOs must comply with cGMP and other regulatory
requirements enforced by the U.S. Food and Drug Administration (FDA) and other regulatory authorities. Any failure to meet these standards
could result in delays, batch failures, regulatory sanctions, or product recalls.

 Loss of Key Manufacturing Partners: If a CDMO terminates its relationship
with us, fails to meet our supply needs, or becomes unable to fulfill its obligations due to financial difficulties, insolvency, or acquisition
by a third party, we may not be able to obtain alternative manufacturing sources in a timely or cost-effective manner.

 Limited Control Over Operations: Because we do not own or operate these third-party
facilities, we have limited control over their manufacturing processes, quality systems, and compliance efforts, which increases our exposure
to risks outside of our direct control.

 Capacity and Scalability Risks: If our CDMO partners are unable
to scale production to meet future clinical or commercial demands, we may experience supply shortages that could delay our development
timelines or commercial launch.

 If a third-party manufacturer was to experience any prolonged disruption
for our manufacturing, or face enforcement scrutiny by regulatory authorities, we could be forced to seek additional third-party manufacturing
contracts, thereby increasing our development costs and negatively impacting our timelines and any commercialization costs. If we change
manufacturers at any point during the development process or after approval of a product candidate, we will be required to demonstrate
comparability between the product manufactured by the old manufacturer and the product manufactured by the new manufacturer. If we are
unable to do so, we may need to conduct additional studies or clinical trials with product manufactured by the new manufacturer, thereby
delaying our NDA submission or approval.

 If the manufacturer upon which we rely
fails to comply with stringent regulations, we may face delays in the development and commercialization of, or be unable to meet demand
for, our product candidates and may lose potential revenues.

 Any problems or delays our contract manufacturers
experience in preparing for commercial-scale manufacturing of a product candidate or component may result in a delay in product development
timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability to manufacture
commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention, or impairment
of clinical development and commercialization of our product candidates and may materially harm our business, financial condition, results
of operations, stock price and prospects.

 In addition, manufacturers of drug products and
their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance
with cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents. Although
we do not have day-to-day control over our contract manufacturers' compliance with these requirements, we are responsible for ensuring
compliance with such requirements. Our failure, or the failure of our contract manufacturers, to comply with applicable regulations could
result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal
of approvals, revocation of licenses, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any
of which would significantly and adversely affect supplies of our product candidates and our business. If a contract manufacturer's
facilities do not pass a pre-approval inspection or do not have a cGMP compliance status acceptable to the FDA or a comparable foreign
regulatory authority, our product candidate will not be approved.

 In addition, application holders must obtain
FDA approval for product and manufacturing changes, depending on the nature of the change. Moreover, in the United States, the distribution
of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. In addition, our marketed
products will have to comply with the Drug Supply Chain Security Act of 2013, which requires drug companies to enable electronic tracking
of their products though the U.S. supply chain.

 Any deviations from regulatory requirements may
also require remedial measures that may be costly and/or time-consuming for us or a third-party to implement and that may include the
temporary or permanent suspension of a clinical trial or the temporary or permanent closure of a facility. Any such remedial measures
imposed upon us or third parties with whom we contract could materially harm our business. Any delays in obtaining products or product
candidates that comply with the applicable regulatory requirements may result in delays to product approvals, and commercialization.
It may also require that we conduct additional trials.

 We face substantial competition, which
may result in others discovering, developing or commercializing competing products more successfully than we do, or, perhaps obtaining
approval before our product and, potentially delaying our approval.

 The development and commercialization of new
drugs is highly competitive. We face competition with respect to developing our current product candidates, and we will face competition
with respect to any products that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty
pharmaceutical companies and biotechnology companies worldwide. We are seeking to develop tecarfarin as an oral and reversible anticoagulant
(blood thinner), to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain rare medical conditions. If
we succeed in developing tecarfarin, we shall face substantial competition. Our competitors include major multi-national pharmaceutical
companies and biotechnology companies developing both generic and proprietary anticoagulant therapies, which have substantially more
resources than we do and substantially more experience developing and marketing pharmaceuticals. Many of our competitors have drugs that
have already been commercialized and therefore benefit from being first to market their products. Many of these companies are well-established
and possess technical, human, research and development, financial, and sales and marketing resources significantly greater than ours.
Potential competitors also include academic institutions, government agencies and other public and private research organizations that
conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization
of competing drugs and potentially competing drugs. Our competitors are or may be attempting to develop therapeutics for our target indications.

 Factors affecting competition in these markets include the financial,
research and development, testing, and marketing strengths of individual competitors, trends in industry consolidation, consumers'
product options, product quality, price and technology, reputation, customer service capabilities and access to market partners and customers.
Eliquis is manufactured and distributed by Bristol Myers Squibb, Pradaxa is manufactured and distributed by Boehringer Ingelheim, Xarelto
is manufactured and distributed by Janssen Pharmaceuticals, and Savaysa is manufactured and distributed by Daiichi Sankyo. We may not
be able to successfully compete with these existing products, including their current or future generic equivalents. Each of these organizations
has a long operating history, extensive resources, strong brand recognition and large customer bases. As a result, we expect they will
be able to devote greater resources than we can to the manufacture, promotion and sale of their products; receive greater resources and
support than we will from market partners and independent distributors; initiate and withstand substantial price competition; and take
advantage more readily than we could of acquisition and other strategic market opportunities. In addition, these or other organizations
could succeed in developing new products that perform better or more cost-effectively than our products and product candidates in their
respective markets. Moreover, changes in health trends, diet or other factors could substantially reduce the commercial attractiveness
or viability of the markets for anti-anginal, anticoagulant, anti-arrhythmic and anti-platelet products.

 The high level of competition in these markets
could result in pricing pressure, reduced margins, the inability of our product candidates to achieve market acceptance and other impediments
to commercial success. As a result, there can be no assurance that we will be able to complete the development of competitive products
and commercialize them on a competitive basis.

 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.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large
and established companies. These companies 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.

 If serious adverse effects are identified
with respect to any of our product candidates or any of our approved products, we may need to modify or abandon our development of that
product candidate, discontinue sale of an approved product, or change our labeling to reflect new safety risks.

 It is impossible to guarantee when, or if, any
of our product candidates will prove safe enough to receive regulatory approval. It is impossible to guarantee that safety issues that
may arise during development will not significantly decrease the commercial potential of our product candidates. In addition, there can
be no assurance that our clinical trials will identify all relevant safety issues. Known or previously unidentified adverse effects can
adversely affect regulatory approvals or marketing of approved products. In such an event, we might need to abandon marketing efforts
or development of that product or product candidate or enter into a partnership to continue development.

 If a regulatory agency discovers adverse events
of unanticipated severity or frequency it may impose restrictions on that product or us, including requiring withdrawal of the product
from the market. Among other legal and administrative actions, a regulatory agency may:

 mandate
 modifications to product labelling or promotional materials or require us to provide corrective
 information to healthcare practitioners;

 withdraw
 any regulatory approvals;

 place
 any ongoing clinical trials on clinical hold;

 refuse
 to approve pending applications or supplements to approved applications filed by us, our
 partners or our potential future partners;

 impose
 restrictions on operations, including costly new manufacturing, licensing or packaging requirements;
 or

 seize
 or detain products or require a product recall.

 In addition, the occurrence of any of the foregoing,
even if promptly remedied, could (1) negatively impact the perception of us or the relevant product among the medical community, patients
or third-party payors and (2) result in product liability litigation that could result in the company paying substantial amounts of money
in settlements or verdicts.

 Recently enacted and future legislation
may increase the difficulty and cost for us to obtain marketing approval of and commercialize tecarfarin and affect the prices we may
obtain.

 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 for tecarfarin, restrict or regulate post-approval activities and affect our ability to profitably sell tecarfarin.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities
for pharmaceutical products. We do not know whether additional legislative changes will be enacted, or whether the FDA regulations, guidance
or interpretations will be changed, or what the impact of such changes on the marketing approvals of tecarfarin, if any, may be. In addition,
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.

 In the United States, under the Medicare Modernization
Act, or MMA, Medicare Part D provides coverage to the elderly and disabled for outpatient prescription drugs by approving and subsidizing
prescription drug plans offered by private insurers. The MMA also authorizes Medicare Part D prescription drug plans to use formularies
where they can limit the number of drugs that will be covered in any therapeutic class. The Part D plans use their formulary leverage
to negotiate rebates and other price concessions from drug manufacturers. Also under the MMA, Medicare Part B provides coverage to the
elderly and disabled for physician-administered drugs on the basis of the drug's average sales price, a price that is calculated
according to regulatory requirements and that the manufacturer reports to Medicare quarterly.

 Both Congress and the Centers for Medicare &
Medicaid Services, or CMS, the agency that administers the Medicare program, from time to time consider legislation, regulations, or
other initiatives to reduce drug costs under Medicare Parts B and D. For example, under the 2010 Affordable Care Act, drug manufacturers
are required to provide a 50% discount on prescriptions for branded drugs filled while the beneficiary is in the Medicare Part D coverage
gap, also known as the "donut hole." The Bipartisan Budget Act of 2018 increased the manufacturer's subsidy under the
program from 50% to 70% of the negotiated price, beginning in 2019. There have been legislative proposals to repeal the "non-interference"
provision of the MMA to allow CMS to leverage the Medicare market share to negotiate larger Part D rebates. Further cost reduction efforts
could decrease the coverage and price that we receive for tecarfarin and could seriously harm our business. Private payors often follow
Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement under the
Medicare program may result in a similar reduction in payments from private payors.

 Additionally, in August 2022, President Biden
signed into law the Inflation Reduction Act (IRA), which includes provisions that effectively authorize the government to establish prices
for certain high-spend single-source drugs and biologics reimbursed by the Medicare program, starting in 2026 for Medicare Part D drugs
and 2028 for Medicare Part B drugs. It is not yet certain which products the federal government will select and subject to government-established
prices, or how the federal government will establish prices for selected products, as the IRA specifies a ceiling price but not a minimum
price. One or more of our product candidates, if approved, could be selected and subject to the government-established price.

 The IRA also contains provisions that impose rebates if certain prices
increase at a rate that outpaces the rate of inflation, beginning October 1, 2022, for Medicare Part D drugs and January 1, 2023, for
Medicare Part B drugs. Separate IRA provisions redesign the Medicare Part D benefit in various ways, including by shifting a greater portion
of costs to manufacturers within certain coverage phases and replacing the Part D coverage gap discount program with a new manufacturer
discounting program. Failure to comply with IRA provisions may subject manufacturers to various penalties, including civil monetary penalties.
The impact of the IRA on our business and the broader pharmaceutical industry remains uncertain, as the federal government has yet to
make various IRA implementation decisions.

 The 2010 Affordable Care Act is intended to broaden
access to health Insurance and reduce or constrain the growth of healthcare spending. Further, the Affordable Care Act imposes a significant
annual fee on companies that manufacture or import branded prescription drug products. It also increased the amount of the rebates drug
manufacturers must pay to state Medicaid programs, required that Medicaid rebates be paid on managed Medicaid utilization, and increased
the additional rebate on "line extensions" (such as extended-release formulations) of solid oral dosage forms of branded
products. The law also contains substantial provisions affecting fraud and abuse compliance and transparency, which may require us to
modify our business practices with healthcare practitioners, and incur substantial costs to ensure compliance.

 Many members of the Republican Party have consistently
opposed the Affordable Care Act since it was signed. Efforts to repeal the Act have been attempted numerous times and some portions of
the Act have been amended in 2017 and 2018. It is unclear whether further amendments or repeal will be effectuated and what the effect
on the healthcare sector will be. In addition to potential changes to the Affordable Care Act, there are indications that the Medicaid
and Medicare programs may be restructured, which could lead to revisions in coverage and reimbursement of prescription drugs. While we
are unable to predict what legislation, if any, may potentially be enacted, to the extent that future changes affect how our product
candidates could be paid for and/or reimbursed by the government and private payers, our business could be adversely affected.

 In addition, other legislative changes have been
proposed and adopted in the United States since the Affordable Care Act was enacted. For example, the Budget Control Act of 2011 included,
among other things, provisions that have led to 2% across-the-board reductions in Medicare payment amounts. Several states have adopted
or are considering adopting laws that require pharmaceutical companies to provide notice prior to raising prices and to justify price
increases. We expect that additional healthcare reform measures will be adopted in the future, any of which could limit the amounts that
federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value
of certain development projects and reduce our profitability.

 If we market any of our products in a manner
that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal
penalties.

 The FDA and other government authorities enforce
laws and regulations that require that the promotion of pharmaceutical products be consistent with the approved prescribing information.
While physicians may prescribe an approved product for a so-called "off-label" use under the practice of medicine, it is
unlawful for a pharmaceutical company to promote its products in a manner that is inconsistent with its approved label and any company
which engages in such conduct may be subject to significant liability. Similarly, industry codes in the European Union and other foreign
jurisdictions prohibit companies from engaging in off-label promotion and regulatory agencies in various countries enforce violations
of the code with civil penalties. While we intend to ensure that our promotional materials are consistent with our label, regulatory
agencies may disagree with our assessment and may issue untitled letters, warning letters or may institute other civil or criminal enforcement
proceedings. In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare
fraud and abuse laws have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. These
laws include the U.S. Federal Healthcare Program Anti-Kickback Statute, U.S. False Claims Act and similar state laws. Because of the
breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to
challenge under one or more of these laws.

 The U.S. Federal Healthcare Program Anti-Kickback
Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in
return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable
under Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted broadly to apply to arrangements
between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there
are several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and
safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may
be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not, in all cases, meet all of the criteria
for safe harbor protection from anti-kickback liability. Moreover, recent health care reform legislation has strengthened these laws.
For example, the Affordable Care Act, among other things, amends the intent requirement of the U.S. Federal Healthcare Program Anti-Kickback
Statute and criminal health care fraud statutes; a person or entity no longer needs to have actual knowledge of this statute or specific
intent to violate it. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services
resulting from a violation of the U.S. Federal Healthcare Program Anti-Kickback Statute constitutes a false or fraudulent claim for purposes
of the U.S. False Claims Act. Federal false claims laws, including the U.S. False Claims Act, impose criminal and civil penalties, including
through civil whistleblower or qui tam actions, against individuals or entities for 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.

 Over the past few years, pharmaceutical and other
healthcare companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as: allegedly
providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting to pricing services
inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion
that caused claims to be submitted to Medicare or Medicaid for non-covered, off-label uses; using a charity as an illegal conduit to
cover the copays of Medicare patients; and submitting inflated best price information to the Medicaid Drug Rebate Program to reduce liability
for Medicaid rebates.

 Other restrictions under applicable U.S. federal
and state healthcare laws and regulations may include the following:

 the
 federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal
 and civil liability for, among other things, knowingly and willfully 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, or HITECH,
 Act and its implementing regulations, also imposes obligations, including mandatory contractual
 terms, on certain types of people and entities with respect to safeguarding the privacy,
 security and transmission of individually identifiable health information;

 the
 federal Physician Payment 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 report payments
 and other transfers of value to physicians and teaching hospitals, as well as certain ownership
 and investment interests held by physicians and their immediate family, which includes annual
 data collection and reporting obligations; and

 analogous
 state and foreign laws and regulations, such as state anti-kickback and false claims laws,
 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 to federal and state agencies. 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. Tracking and reporting may be burdensome and require a significant expenditure
to comply with applicable requirements.

 Our ability to generate product revenues
will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.

 Our ability to commercialize our products, alone
or with collaborators, will depend in part on the extent to which reimbursement will be available from:

 government
 and health administration authorities;

 private
 health maintenance organizations and health insurers; and

 other
 healthcare payers.

 Patients generally expect that products such
as ours are covered and reimbursed by third-party payors for all or part of the costs and fees associated with their use. If such products
are not covered and reimbursed then patients may be responsible for the entire cost of the product, which can be substantial. Therefore,
health care providers generally do not prescribe products that are not covered and reimbursed by third-party payors in order to avoid
subjecting their patients to such financial liability. The existence of adequate coverage and reimbursement for the products by government
and private insurance plans is central to the acceptance of tecarfarin and any future products we provide.

 During the past several years, third-party payors
have undertaken cost-containment initiatives including different payment methods, monitoring health care expenditures, and anti-fraud
initiatives. For some governmental programs, such as Medicaid, coverage and reimbursement differ from state to state, and some state
Medicaid programs may not pay an adequate amount for tecarfarin or any of our other products or may make no payment at all. Furthermore,
the health care industry in the United States has experienced a trend toward cost containment as government and private insurers seek
to control health care costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Therefore,
we cannot be certain that our services will be reimbursed at a level that is sufficient to meet our costs.

 Obtaining coverage and reimbursement approval
of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to
the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for a given
product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments
that patients find unacceptably high. Patients are unlikely to use tecarfarin or any future product candidates unless coverage is provided
and reimbursement is adequate to cover a significant portion of the cost of tecarfarin or any future product candidates.

 We intend to seek approval to market tecarfarin
and future product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign
jurisdictions for tecarfarin or any future product candidates, we will be subject to rules and regulations in those jurisdictions. In
some foreign countries, particularly those in the European Union, the pricing of drugs is subject to governmental control. In these countries,
pricing negotiations with governmental authorities can take considerable time after obtaining marketing approval of a product candidate.
In addition, market acceptance and sales of product candidates will depend significantly on the availability of adequate coverage and
reimbursement from third-party payors for product candidates and may be affected by existing and future health care reform measures.

 Third-party payors, whether domestic or foreign,
or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United
States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that
could impact our ability to sell our products profitably. In particular, in the Affordable Care Act, as amended by the Health Care and
Education Affordability Reconciliation Act, among other things, revised the methodology by which rebates owed by manufacturers to the
state and federal government for covered outpatient drugs, including product candidates, under the Medicaid Drug Rebate Program are calculated,
increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug
Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers
to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government's
comparative effectiveness research.

 The impact of recent healthcare reform legislation,
other changes in the healthcare industry, and in healthcare spending is currently unknown and may adversely affect our business model.

 Our revenue prospects could be affected by changes
in healthcare spending and policy in the U.S. and abroad. We operate in a highly regulated industry, and new laws, regulations, judicial
decisions, or new interpretations of existing laws, regulations, or decisions related to healthcare availability, the method of delivery,
or payment for healthcare tests, products, and services could negatively impact our business, operations, and financial condition.

 There have been, and likely will continue to be,
legislative and regulatory proposals at the foreign, federal, and state levels directed at broadening the availability of healthcare and
containing or lowering the cost of healthcare, including proposals aimed at lowering prescription drug prices and increasing competition
for prescription drugs, as well as additional regulation on pharmaceutical transparency and reporting requirements, any of which could
negatively impact our future profitability and increase our compliance burden. We cannot predict the initiatives that may be adopted in
the future, including future challenges or significant revisions to the Affordable Care Act. The continuing efforts of the government,
insurance companies, managed care organizations, and other payors to contain or reduce costs of healthcare and/or impose price controls
may adversely affect:

 the demand for our therapeutic products, if we
or our licensors obtain regulatory approval;

 the ability to set a price that we believe is
fair for a therapeutic product;

 the ability to obtain coverage and reimbursement
approval for a therapeutic product;

 our ability to generate revenue and achieve or
maintain profitability;

 the level of taxes that we are required to pay;
and

 the availability of capital.

 Any reduction in reimbursement from Medicare or
other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.

 There have been, and likely will continue to
be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare
and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future, particularly
in light of the new presidential administration in the United States, and any proposed changes to healthcare laws that could potentially
affect our clinical development or regulatory strategy. The continuing efforts of the government, insurance companies, managed care organizations
and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

 the
 demand for tecarfarin, or future product candidates, if we obtain regulatory approval;

 our
 ability to set a price that we believe is fair for our products;

 our
 ability to generate revenue and achieve or maintain profitability;

 the
 level of taxes that we are required to pay; and

 the
 availability of capital.

 Any reduction in reimbursement from Medicare,
Medicaid or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our
future profitability.

 We will rely on third parties and consultants
to conduct all of our clinical trials. If these third parties or consultants do not successfully carry out their contractual duties,
comply with regulatory requirements, or meet expected deadlines, we may be unable to obtain regulatory approval for any future product
candidates.

 We will rely on medical institutions, clinical
investigators, contract laboratories, collaborative partners and other third parties, such as CROs, to conduct clinical trials on our
product candidates. The third parties with whom we may contract for execution of any of our future clinical trials may play a significant
role in the conduct of these trials and the subsequent collection and analysis of data. These third parties would not be our employees,
and except for contractual duties and obligations, we would have limited ability to control the amount or timing of resources that they
devote to any of our future programs. Although we may rely on these third parties to conduct our clinical trials, we would remain responsible
for ensuring that each of our preclinical trials and clinical trials is conducted in accordance with applicable legal requirements, the
investigational plan and the protocol. Moreover, whether we conduct trials ourselves or hire third parties to do so, the FDA and other
similar regulatory authorities require us to comply with GCPs when we conduct, monitor, record and report the results of clinical trials
to ensure that the data and results are scientifically credible and accurate, and that the trial subjects are adequately informed of
the potential risks of participating in clinical trials.

 In addition, the execution of clinical trials,
and the subsequent compilation and analysis of the data produced, requires coordination among various parties. In order for these functions
to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. Moreover,
these third parties may also have relationships with other commercial entities, some of which may compete with us. If the third parties
or consultants conducting 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 the failure to adhere to our clinical trial protocols or GCPs, or for any other reason, we may need
to conduct additional clinical trials or enter into new arrangements with alternative third parties, which could be difficult, costly
or impossible, and our clinical trials may be extended, delayed or terminated or may need to be repeated. If any of the foregoing were
to occur, we may not be able to obtain, or may be delayed in obtaining, regulatory approval for and will not be able to, or may be delayed
in our efforts to, successfully commercialize any future product candidates being tested in such trials.

 We currently have limited distribution,
marketing, support and sales capabilities and plan to rely on third-party distribution partners for the distribution, marketing, support
and sales of our products which could delay or limit our ability to generate revenue.

 We plan to utilize third-party service providers
for the distribution and marketing and sales of our product candidates, if approved. Upon launch, we intend to promote utilizing third
party collaborations in addition to building our own commercial infrastructure in anticipation of the approval of tecarfarin. Reliance
on third-party service providers may prevent our direct control of key aspects of those critical functions including regulatory compliance,
import and export operations, supply chain security, warehousing and inventory management, distribution, contract administration, invoicing,
sales deductions administration, accounts receivable management and call center management. Any future distribution partners may hold
significant control over important aspects of the commercialization of our products, including market identification, regulatory compliance,
marketing methods, pricing, composition of sales force and promotional activities.

 We may not be able to control the amount and
timing of resources that any future third-party distribution partners may devote to our products, or prevent any third-party from pursuing
the development of alternative technologies or products that compete with our products, except to the extent our contractual arrangements
protect us against such activities. Also, we may not be able to prevent any other third-party from withdrawing its support of our products.

 If third-party service providers fail to comply
with applicable laws and regulations, fail to meet expected deadlines, encounter natural or other disasters at their facilities or otherwise
fail to perform their services to us in a satisfactory or predicted manner, or at all, our ability to deliver product to meet commercial
demand could be significantly impaired. In addition, we may use third parties to perform various other services for us relating to sample
accountability and regulatory monitoring, including adverse event reporting, safety database management and other product maintenance
services. If the quality or accuracy of the data maintained by these service providers is insufficient, our ability to continue to market
our products could be jeopardized or we could be subject to regulatory sanctions, and any indemnity we may receive from such third-party
service providers could be limited by such provider's ability to pay and otherwise might not be sufficient to cover all losses
we may experience.

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

 We are exposed to the risk of employee fraud
or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these
parties could include intentional, reckless and/or negligent conduct that fails to: (i) comply with the laws of the FDA and other similar
foreign regulatory bodies; (ii) provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies;
(iii) comply with manufacturing standards we have established; (iv) comply with healthcare fraud and abuse laws in the United States
and similar foreign fraudulent misconduct laws; or (v) report financial information or data accurately or to disclose unauthorized activities
to us. Any such misconduct or noncompliance could negatively affect the FDA's review of our regulatory submission, including delaying
approval or disallowance of certain information to support the submission, and/or delay a federal or state healthcare programs or a commercial
insurer's determination regarding the availability of future reimbursement for product candidates. If we obtain FDA approval of
any product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase
significantly, and our costs associated with compliance with such laws are also likely to increase. These laws may impact, among other
things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and
education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements
in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s),
certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper
use of information obtained in the course of patient recruitment for clinical trials.

 It is not always possible to identify and deter
employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown
or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure
to be in compliance with such laws or regulations. Efforts to ensure that our business arrangements will comply with applicable healthcare
laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices
may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws
and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights,
those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties,
damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs,
contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could
adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of
any product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned
above, among other foreign laws.

 We intend to establish a sales force to
market our product candidates. If we are not successful in doing so, our ability to generate sales and profits will be limited.

 Although certain of our employees have commercialization
experience, as a company we do not have an internal sales force and we currently have only limited commercial capabilities. We intend
to establish an internal specialty sales force for the promotion and sale of tecarfarin, if approved. Establishing a pharmaceutical sales
force is a difficult undertaking. Experienced and competent sales representatives and sales managers must be recruited, hired, trained,
assigned appropriate territories, managed and compensated in such a way that they can achieve success in selling products to a sophisticated
audience of healthcare professionals who frequently have little or no time to spend with sales personnel. In addition, our prospective
sales force must compete against the sales forces of some of the largest and most successful pharmaceutical companies in the world, who
will be promoting competing products. If we fail to hire and field a high-quality sales force, we may be unable to generate expected
revenues and profits.

 In addition, there are significant expenses and
risks involved with establishing our own sales and marketing capabilities, including our ability to hire, retain and appropriately incentivize
qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage
a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution
capabilities could delay any product launch, which would adversely impact the commercialization of our product candidates. For example,
if we recruit any sales representatives or establish marketing capabilities prior to commercial launch and the commercial launch is delayed
or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly,
and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

 In addition to our own internal sales force,
we may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment
our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into
such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our product candidates. To the extent
we commercialize our product candidates by entering into agreements with third-party collaborators, we may have limited or no control
over the sales, marketing and distribution activities of these third parties, in which case our future revenues would depend heavily
on the success of the efforts of these third parties. If we are not successful in commercializing tecarfarin or any future product candidates,
either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we could incur
significant additional losses.

 We plan to rely on collaborations and license
arrangements with third parties to commercialize, market and promote our marketed products which may limit our ability to generate revenue
and adversely affect our profitability.

 We plan to rely on collaboration and other agreements
with third parties with respect to our product candidates and future marketed products. Our current or any future collaborations or license
arrangements may not be successful. With respect to the product candidates we have out-licensed, including our rights to tecarfarin in
China, we depend upon collaborations with third parties to develop these product candidates in the licensed territories and we will depend
substantially upon third parties to commercialize these product candidates. If we are unable to maintain current collaborations or enter
into additional collaborations with established pharmaceutical or pharmaceutical service companies to provide the services we need, we
may not be able to successfully commercialize our products.

 Our future growth depends, in part, on
our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.

 Although our focus as this time is primarily
on the U.S. market, our future profitability will depend, in part, on our ability to commercialize tecarfarin in foreign markets for
which we intend to rely on collaborations with third parties. If we commercialize tecarfarin in foreign markets, we would be subject
to additional risks and uncertainties, including:

 our
 customers' ability to obtain reimbursement in foreign markets;

 our
 inability to directly control commercial activities because we are relying on third parties;

 the
 burden of complying with complex and changing foreign regulatory, tax, accounting and legal
 requirements;

 different
 medical practices and customs in foreign countries affecting acceptance in the marketplace;

 import,
 export and foreign licensing requirements;

 different
 packaging and labeling requirements;

 longer
 accounts receivable collection times;

 longer
 lead times for shipping;

 language
 barriers for technical training;

 differing
 and/or reduced protection of intellectual property rights in some foreign countries;

 foreign
 currency exchange rate fluctuations; and

 the
 interpretation of contractual provisions governed by foreign laws in the event of a contract
 dispute.

 Foreign sales of tecarfarin could also be adversely
affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs, any
of which may adversely affect our results of operations.

 Global health crises may adversely affect
our planned operations.

 Our business and the businesses of our third-party pharmaceutical manufacturers
could be materially and adversely affected by the risks, or the public perception of the risks, related to a pandemic or other health
crisis. If there is a global health crisis, we could experience delays in patient enrollment and significant disruptions to our clinical
development timelines. If we experience delays in patient enrollment or patient dropouts and we deem it necessary or advisable to improve
patient recruitment by, among other things, opening additional clinical sites, we could incur increased clinical program expenses. Any
such disruptions or delays would, and any such increased clinical program expenses could, adversely affect our business, financial condition,
results of operations and growth prospects. We may experience disruptions as a result of a global health crisis, including:

 unwillingness
 of potential study participants to enroll in our pivotal Phase 3 clinical trial and/or visit
 healthcare facilities;

 postponement
 of enrollment in our pivotal Phase 3 clinical trial

 postponement
 of the initiation of our pivotal Phase 3 clinical trial;

 diversion
 of healthcare resources away from the conduct of clinical trials, including the diversion
 of hospitals serving as our clinical trial sites and hospital staff supporting the conduct
 of our clinical trial;

 interruption
 of key clinical trial activities, such as clinical site visits by study participants and
 clinical trial site monitoring, due to limitations on travel imposed or recommended by federal
 or state governments, employers and others;

 limitations
 in employee resources that would otherwise be focused on the conduct of our pivotal Phase
 3 clinical trial, including because of sickness of employees or their families or the desire
 of employees to avoid contact with large groups of people;

 delays
 in receiving approval from local regulatory authorities to initiate our pivotal Phase 3 clinical
 trial;

 delays
 in clinical sites receiving the supplies and materials needed to conduct our pivotal Phase
 3 clinical trial;

 interruption in global
 shipping that may affect the manufacture and transport of clinical trial materials, such as investigational drug product used in
 our clinical trial;

 changes
 in local regulations as part of a response to the COVID-19 coronavirus outbreak which may
 require us to change the ways in which our pivotal Phase 3 clinical trial is conducted, which
 may result in unexpected costs, or to discontinue the clinical trial altogether;

 delays
 in necessary interactions with local regulators, ethics committees and other important agencies
 and contractors due to limitations in employee resources or forced furlough of government
 employees; and

 delay
 in the timing of interactions with the FDA due to absenteeism by federal employees or by
 the diversion of their efforts and attention to approval of other therapeutics or other activities
 related to COVID-19.

 Our business and the business of the suppliers
of our clinical product candidate may be materially and adversely affected by a global health crisis, including a resurgence of COVID-19,
including the delay or complete or partial closure of clinical trial sites or one or more manufacturing facilities which could impact
our supply of our clinical product candidate. In addition, it could impact economies and financial markets, resulting in an economic
downturn that could impact our ability to raise capital or slow down potential partnering relationships.

 In addition, a global health crisis could disrupt
our operations due to absenteeism by infected or ill members of management or other employees, or absenteeism by members of management
and other employees who elect not to come to work due to the illness affecting others in our office, or due to quarantines. A global
health crisis could also impact members of our Board of Directors resulting in absenteeism from meetings of the directors or committees
of directors, and making it more difficult to convene the quorums of the full Board of Directors or its committees needed to conduct
meetings for the management of our affairs.

 The extent to which a resurgence of COVID-19
or another global health crisis may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence.
While the original spread of COVID-19 has been mitigated, the continued emergence of novel virus strains means there is no guarantee
that a future outbreak of this or any other widespread epidemics will not occur, or that the global economy will recover, either of which
could seriously harm our business.

 Compliance with governmental regulations
regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization
of our products.

 The Animal Welfare Act, or AWA, is the federal
law that covers the treatment of certain animals used in research. Currently, the AWA imposes a wide variety of specific regulations
that govern the humane handling, care, treatment and transportation of certain animals by producers and users of research animals, most
notably relating to personnel, facilities, sanitation, cage size, and feeding, watering and shipping conditions. Third parties with whom
we contract are subject to registration, inspections and reporting requirements under the AWA. Furthermore, some states have their own
regulations, including general anti-cruelty legislation, which establish certain standards in handling animals. Comparable rules, regulations,
and or obligations exist in many foreign jurisdictions. If we or our contractors fail to comply with regulations concerning the treatment
of animals used in research, we may be subject to fines and penalties and adverse publicity, and our operations could be adversely affected.

 General Company-Related Risks

 If we fail to attract and keep senior management
and key scientific personnel, we may be unable to successfully develop tecarfarin or any future product candidates, conduct our clinical
trials and commercialize our product candidates or any future products we develop.

 Our management team has expertise in many different aspects of fundraising,
drug development and commercialization. We believe that our future success is highly dependent upon the contributions of our senior management,
particularly Quang X. Pham, our Chief Executive Officer. We do not have an insurance policy on the life of our Chief Executive Officer
and we do not have "key person" life insurance policies for any of our other officers or advisors. The loss of services of
any of these individuals could delay or prevent the successful development of our product pipeline, completion of our planned clinical
trials or the commercialization of tecarfarin or any other future products we develop, which could adversely affect our operating results.

 We will need to hire additional personnel, including
experienced marketing and sales representatives, as we expand our clinical development and commercial activities. We could experience
difficulties attracting and retaining qualified employees in the future. For example, competition for qualified personnel in the pharmaceuticals
field is intense due to the limited number of individuals who possess the skills and experience required by our industry. Other pharmaceutical
companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles, and a longer
history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some
of these characteristics may be more appealing to high-quality candidates than what we have to offer. We may not be able to attract and
retain quality personnel on acceptable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject
to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information or that
their former employers own their research output. If we are unable to continue to attract and retain high-quality personnel, the rate
and success at which we can develop and commercialize product candidates could be limited.

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

 We will need to continue to expand our managerial,
operational, finance and other resources to manage our operations, commercialize tecarfarin or any other product candidates, if approved,
and continue our development activities. Our management and personnel systems and facilities currently in place may not be adequate to
support this future growth. Our need to effectively execute our growth strategy requires that we:

 manage
 any of our future clinical trials effectively;

 identify,
 recruit, retain, incentivize and integrate additional employees;

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

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

 Due to our limited financial resources and our
limited experience in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our
operations or recruit and train additional qualified personnel. The physical expansion of our operations may lead to significant costs
and may divert our management and business development resources. Any inability to manage growth could delay the execution of our development
and strategic objectives or disrupt our operations.

 If product liability lawsuits are brought
against us, we may incur substantial liabilities and may be required to limit the commercialization of any future products we develop.

 We face an inherent risk of product liability
as a result of the clinical testing of tecarfarin and any of our future product candidates. We will face further risk if we commercialize
tecarfarin or any of our product candidates. For example, we may be sued if any product we sell or any product we develop allegedly causes
injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims
may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence,
strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully
defend ourselves against product liability claims, we may incur substantial losses or be required to limit the commercialization of our
products. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual
outcome, liability claims may result in:

 decreased
 demand for our product candidates or products we develop, including tecarfarin;

 termination
 of clinical trial sites or entire trial programs;

 injury
 to our reputation and significant negative media attention;

 withdrawal
 of clinical trial participants or cancellation of clinical trials;

 significant
 costs to defend the related litigation;

 a
 diversion of management's time and our resources;

 substantial
 monetary awards to trial participants or patients;

 regulatory
 investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;

 loss
 of revenue;

 the
 inability to commercialize any products we develop; and

 a
 decline in our share price.

 Our inability to obtain and maintain sufficient
product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent
or inhibit the commercialization of tecarfarin or any future products that we develop. We currently carry product liability insurance
covering our marketed products and our clinical trials. Although we maintain such insurance, 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. Our insurance policies also have various exclusions and deductibles, and we may be subject
to a product liability claim for which we have no coverage. 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. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient
amounts to protect us against losses. If and when we obtain approval for marketing tecarfarin, we intend to expand our insurance coverage
to include the sale of tecarfarin, however, we may be unable to obtain this liability insurance on commercially reasonable terms.

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

 Despite the implementation of security measures,
our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware,
natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the internet, attachments
to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach
or disruption, particularly through cyber-attacks or cyber-intrusions, including by computer hackers, foreign governments, and cyber-terrorists,
has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased.
If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our current or
future product development programs. For example, the loss of clinical trial data from completed or any future ongoing or planned clinical
trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate
disclosure of confidential or proprietary information, we could incur material legal claims and liability, damage to our reputation,
and the further development of our product candidates could be delayed.

 We are increasingly dependent on information
technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

 Significant disruptions to our information technology systems or breaches
of information security could adversely affect our business. In the ordinary course of business, we collect, store and transmit large
amounts of confidential information and will continue to do so once we commence clinical trials, and it is critical that we do so in a
secure manner to maintain the confidentiality and integrity of such confidential information. The size and complexity of our information
technology systems, and those of our third-party vendors with whom we contract, make such systems potentially vulnerable to service interruptions
and security breaches from inadvertent or intentional actions by our employees, partners or vendors, from attacks by malicious third parties,
or from intentional or accidental physical damage to our systems infrastructure maintained by us or by third parties. Maintaining the
secrecy of this confidential, proprietary, or trade secret information is important to our competitive business position. While we have
taken steps to protect such information and invested in information technology, there can be no assurance that our efforts will prevent
service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential
information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive
information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation
or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud,
trickery or other forms of deception, or for any other reason, could enable others to produce competing products, use our proprietary
technology or information, or adversely affect our business or financial condition. Further, any such interruption, security breach, loss
or disclosure of confidential information, could result in financial, legal, business, and reputational harm to us and could have a material
adverse effect on our business, financial position, results of operations or cash flow.

 Any failure to maintain the security of
information relating to our patients, customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise,
could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm
our reputation.

 In connection with the pre-clinical and clinical
development, sales and marketing of our products and services, we may from time to time transmit confidential information. We also have
access to, collect or maintain private or confidential information regarding our clinical trials and the patients enrolled therein, employees,
and suppliers, as well as our business. Cyberattacks are rapidly evolving and becoming increasingly sophisticated. It is possible that
computer hackers and others might compromise our security measures, or security measures of those parties that we do business with now
or in the future, and obtain the personal information of patients in our clinical trials, vendors, employees and suppliers or our business
information. A security breach of any kind, including physical or electronic break-ins, computer viruses and attacks by hackers, employees
or others, could expose us to risks of data loss, litigation, government enforcement actions, regulatory penalties and costly response
measures, and could seriously disrupt our operations. Any resulting negative publicity could significantly harm our reputation, which
could cause us to lose market share and have an adverse effect on our results of operations.

 We may acquire other businesses or form
joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders'
ownership, increase our debt or cause us to incur significant expense.

 As part of our business strategy, we may pursue
acquisitions of businesses and assets. We also may pursue strategic alliances and joint ventures that leverage our technology and industry
experience to expand our offerings or other capabilities. Though certain company personnel have business development and corporate transaction
experience, including with licensing, mergers and acquisitions, and strategic partnering, as a company we have no experience with acquiring
other companies and limited experience with forming strategic alliances and joint ventures. We may not be able to find suitable partners
or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions,
we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent
liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities,
any of which could have a material adverse effect on our financial condition, results of operations and cash flows. Integration of an
acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing
business. We may experience losses related to investments in other companies, which could have a material negative effect on our results
of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may
not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.

 To finance any acquisitions or joint ventures,
we may choose to issue shares of our Common Stock as consideration, which would dilute the ownership of our stockholders. If the price
of our Common Stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our stock
as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings.
Additional funds may not be available on terms that are favorable to us, or at all.

 Changes in general economic or business
conditions, including tariff and customs regulations, may have a negative impact on our business.

 Continuing concerns over U.S. health care reform
legislation and energy costs, geopolitical issues, the availability and cost of credit and government stimulus programs in the United
States and other countries have contributed to increased volatility and diminished expectations for the global economy. These factors,
combined with low business and consumer confidence, could precipitate an economic slowdown and recession. Additionally, political changes
in the U.S. and elsewhere in the world have created a level of uncertainty in the markets. If the economic climate does not improve or
deteriorate, our business, as well as the financial condition of our suppliers and our third-party payors, could be adversely affected,
resulting in a negative impact on our business, financial condition and results of operations.

 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. In an inflationary environment,
such cost increases may outpace our expectations, causing us to use cash faster than forecasted. In addition, the Federal Reserve has
raised, and may again raise, interest rates in response to concerns about inflation, which coupled with reduced government spending and
volatility in financial markets may have the effect of further increasing economic uncertainty and heightening these risks.

 Changes in U.S. or international social, political, regulatory and
economic conditions or in laws and policies governing trade, manufacturing, development and investment in the countries where we currently
conduct our business could adversely affect our business, reputation, financial condition and results of operations. Changes or proposed
changes in U.S. or other countries' trade policies may result in restrictions and economic disincentives on international trade.
The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain trade partners. Tariffs, economic sanctions
and other changes in U.S. trade policy have in the past and could in the future trigger retaliatory actions by affected countries, and
certain foreign governments have instituted or are considering imposing retaliatory measures on certain U.S. goods. Further, any emerging
protectionist or nationalist trends (whether regulatory- or consumer-driven) either in the United States or in other countries could affect
the trade environment. Our business, like many other corporations, would be impacted by changes to the trade policies of the United States
and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions). Such
changes have the potential to adversely impact the U.S. economy or certain sectors thereof, the global economy, and our industry, and
as a result, could have a material adverse effect on our business, financial condition and results of operations.

 Actual events involving reduced or limited liquidity,
defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services
industry or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past and may
in the future lead to market-wide liquidity problems.

 In addition, the global macroeconomic environment could be negatively
affected by, among other things, pandemics or epidemics, instability in global economic markets, increased U.S. trade tariffs and trade
disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment
as a result of the withdrawal of the United Kingdom from the European Union, the Russian invasion of Ukraine, the war in the Middle East
and other political tensions, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty
and instability in local economies and in global financial markets.

 We are actively monitoring the effects these
disruptions and increasing inflation could have on our operations. These conditions make it extremely difficult for us to accurately
forecast and plan future business activities.

 Global climate change and related regulations
could negatively affect our business.

 The effects of climate change, such as extreme
weather conditions, create financial risks to our business. For example, the demand for our products may be affected by unseasonable
weather conditions. The effects of climate change could also disrupt our operations by impacting the availability and cost of materials
needed for manufacturing and could increase insurance and other operating costs. We could also face indirect financial risks passed through
the supply chain and disruptions that could result in increased prices for our products and the resources needed to produce them.

 Climate change is continuing to receive ever-increasing
attention worldwide. Many scientists, legislators and others attribute climate change to increased levels of greenhouse gases, including
carbon dioxide, which could lead to additional legislative and regulatory efforts to limit greenhouse gas emissions. For example, new
federal or state restrictions on emissions of carbon dioxide that may be imposed on vehicles and automobile fuels could adversely affect
demand for vehicles, annual miles driven or the products we sell or lead to changes in automotive technology. Compliance with any new
or more stringent laws or regulations, or stricter interpretations of existing laws, could require increased capital expenditures to
improve our product portfolio to meet such new laws, regulations and standards. While we have been committed to continuous improvements
to our product portfolio to meet and exceed anticipated regulatory standard levels, there can be no assurance that our commitments will
be successful, that our products will be accepted by the market, that proposed regulation or deregulation will not have a negative competitive
impact or that economic returns will reflect our investments in new product development.

 Risks Related to Our Intellectual Property

 If we are unable to obtain and maintain
sufficient exclusivity and/or patent protection for our product candidates, or if the scope of the exclusivity or patent protection is
not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to commercialize
our product candidates successfully may be adversely affected.

 Our success largely depends on our ability to obtain and maintain exclusivity
for our proprietary product candidates through market and data exclusivity granted by regulatory agencies in the United States and other
countries with respect to our proprietary product candidates as well as through patent protection. If we do not adequately protect our
intellectual property, competitors may be able to erode or negate any competitive advantage we may have, which could harm our business
and ability to achieve profitability. To protect our proprietary position, we file patent applications in the United States and abroad
related to our novel product candidates that are important to our business. The patent application and approval process are expensive
and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in
a timely manner.

 Generally, the patent position of pharmaceutical
companies is highly uncertain. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to
date in the United States or in many foreign jurisdictions. In addition, the determination of patent rights with respect to pharmaceutical
compounds commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation. As a
result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain.

 Assuming the other requirements for patentability
are met, currently, the first to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in
the United States, the first to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag
behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until
18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed
in our patents, or that we were the first to file for patent protection of such inventions.

 Moreover, because the issuance of a patent is
not conclusive as to its inventorship, scope, validity or enforceability, our patents may be challenged in the courts or patent offices
in the United States and abroad. For example, we may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent
and Trademark Office, or USPTO, or become involved in post-grant review procedures, oppositions, derivations, reexaminations, inter
partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights
of others. An adverse determination in any such challenge may result in loss of exclusivity or in patent claims being narrowed, invalidated,
or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical
technology and products or limit the duration of the patent protection of our technology and products. In addition, given the amount
of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might
expire before or shortly after such candidates are commercialized.

 Our future patent applications may not result
in patents being issued which protect our product candidates, in whole or in part, or which effectively prevent others from commercializing
competitive products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries
may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not
protect our rights to the same extent or in the same manner as the laws of the United States. For example, European patent law restricts
the patentability of methods of treatment of the human body more than United States law does.

 Even if our patent applications issue as patents,
they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise
provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative
technologies or products in a non-infringing manner. Our competitors may also seek approval to market their own products similar to or
otherwise competitive with our products. Alternatively, our competitors may seek to market generic versions of any approved products
by submitting ANDAs to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable or not infringed.
In these circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent infringement.
In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or that
our competitors are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may
not provide protection against competing products or processes sufficient to achieve our business objectives.

 Depending upon the timing, duration and conditions
of FDA marketing approval of our product candidates, one or more of our U.S. patents may be eligible for limited patent term extension
under the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved
product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we
may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or
otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. If we are unable
to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our
patent rights for that product will be shortened compared to expectations and our competitors may obtain approval to market competing
products sooner. As a result, our revenue from applicable products could be reduced, possibly materially. Further, if this occurs, our
competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch
their product earlier than might otherwise be the case.

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

 Competitors may infringe our patents, trademarks,
copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims,
which can be expensive and time consuming and divert the time and attention of our management and scientific personnel. Any claims we
assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents,
in addition to counterclaims asserting that our patents are invalid or unenforceable, or both. In any patent infringement proceeding,
there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have
the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents
is upheld, the court will construe the patent's claims narrowly or decide that we do not have the right to stop the other party
from using the invention at issue on the grounds that our patent claims do not cover the invention. An adverse outcome in a litigation
or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors, and may
curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences
could adversely affect our competitive business position, business prospects and financial condition.

 Similarly, if we assert trademark infringement
claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted
trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease the use of
such trademarks.

 Even if we establish infringement, the court
may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not
be an adequate remedy. 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 could be compromised by disclosure during litigation. There could
also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts
or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our Common Stock.
Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims,
which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation
and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the
proceedings.

 Furthermore, while we have engaged intellectual
property counsel to assist in protecting our patent ownership rights, to date, we have not had intellectual property counsel conduct
a freedom to operate analysis regarding our tecarfarin product. As a result, we cannot be certain that we will not be exposed to third-party
legal claims, liabilities and/or litigation actions when we seek to develop, make and market products using our tecarfarin technology.

 If we are sued for infringing the intellectual
property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or
commercializing our product candidates.

 Our commercial success depends, in part, on our
ability to develop, manufacture, market and sell our product candidates without infringing the intellectual property and other proprietary
rights of third parties. If any third-party patents or patent applications are found to cover our product candidates or their methods
of use, we may not be free to manufacture or market our product candidates as planned without obtaining a license, which may not be available
on commercially reasonable terms, or at all.

 There is a substantial amount of intellectual
property litigation in the pharmaceutical industry, and we may become party to, or threatened with, litigation or other adversarial proceedings
regarding intellectual property rights with respect to our product candidates, including interference and other administrative proceedings
before the USPTO. Third parties may assert infringement claims against us based on existing or future intellectual property rights. The
outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance. The pharmaceutical
industry has produced a significant number of patents, and it may not always be clear to industry participants, including us, which patents
cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation
is not always uniform. If we were sued for patent infringement, we would need to demonstrate that our product candidates, products, or
methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we
may not be able to do this. In the United States, proving invalidity (except in proceedings before the USPTO) requires a showing of clear
and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings,
we may incur substantial costs, and the time and attention of our management and scientific personnel could be diverted in pursuing these
proceedings, which could significantly harm our business and operating results. In addition, we may not have sufficient resources to
bring these actions to a successful conclusion.

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

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

 As is the case with other pharmaceutical companies, our success is
heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involves
both technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Recent patent reform legislation
in the United States and other countries, including the Leahy-Smith America Invents Act, or the Leahy-Smith Act, signed into law in September
2011, could increase those uncertainties and costs. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These
include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective
avenues for competitors to challenge the validity of patents. In addition, the Leahy-Smith Act has transformed the U.S. patent system
into a "first to file" system. The first-to-file provisions, however, only became effective on March 16, 2013. Accordingly,
it is not yet clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act
and its implementation could make it more difficult to obtain patent protection for our inventions and increase the uncertainties and
costs surrounding the enforcement or defense of our or our collaboration partner's issued patents, all of which could harm our business,
results of operations, and financial condition.

 The U.S. Supreme Court has ruled on several patent
cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of
patent owners in certain situations. Additionally, there have been recent proposals for additional changes to the patent laws of the
United States and other countries that, if adopted, could impact our ability to enforce our proprietary technology. Depending on future
actions by the U.S. Congress, the U.S. courts, the USPTO, and the relevant law-making bodies in other countries, the laws, and regulations
governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents
and patents that we might obtain in the future.

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

 Periodic maintenance fees on any issued patent
are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various
foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payments and other similar provisions
during the patent application process. While an inadvertent lapse can, in many cases, be cured by payment of a late fee or by other means
in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent
or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that
could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official
actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. If we fail
to maintain the patents and patent applications covering our product candidates, our competitive position would be adversely affected.

 We may not be able to enforce our intellectual
property rights throughout the world.

 Filing, prosecuting, and defending patents on
our product candidates in all countries throughout the world would be prohibitively expensive. The requirements for patentability may
differ in certain countries, particularly in developing countries. 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 may obtain patent protection, but where patent enforcement is not as strong as that in the United States. These products may compete
with our products in jurisdictions where we do not have any issued or licensed patents or where any future patent claims or other intellectual
property rights may not be effective or sufficient to prevent them from competing with us.

 Moreover, our ability to protect and enforce
our intellectual property rights may be adversely affected by unforeseen changes in foreign intellectual property laws. Additionally,
laws of some countries outside of the United States and Europe do not afford intellectual property protection to the same extent as the
laws of the United States and Europe. Many companies have encountered significant problems in protecting and defending intellectual property
rights in certain foreign jurisdictions. This could make it difficult for us to stop the infringement of our patents or the misappropriation
of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner
must grant licenses to third parties. Consequently, we may not be able to prevent third parties from practicing our inventions in certain
countries outside the United States and Europe. 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,
if our ability to enforce our patents to stop infringing activities is inadequate. 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.

 Proceedings to enforce our patent rights in foreign
jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and resources from other aspects of
our business. Furthermore, while we intend to protect our intellectual property rights in major markets for our products, we cannot ensure
that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our products. Accordingly,
our efforts to protect our intellectual property rights in such countries may be inadequate.

 Our two issued U.S. patents with respect
to tecarfarin expired in 2024 and our foreign patents will expire in April 2025 and, therefore, we will lose protection from all of our
patents next month.

 Patents have a limited lifespan. In the United States, the natural
expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and
the protection it affords, is limited. Even if we obtain additional patents covering our product candidates, once the patent life has
expired for a product, we may be open to competition from other products. If the lives of our patents are not sufficient to effectively
protect our products and business, our business and results of operations will be adversely affected. Given the amount of time required
for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or
shortly after such candidates are commercialized.

 We have lost effective patent protection in the United States and will
lose effective patent protection in key countries outside of the United States this year. See supra the section entitled "Intellectual
Property". With respect to tecarfarin, we had two issued U.S. patents directed to tecarfarin for composition of matter and method
of treatment, both of which expired in 2024, and our foreign patents directed to tecarfarin, for composition of matter and use, expire
in April 2025. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension
of up to five years beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications
approved during the period of extension). However, we are no longer able to seek patent extensions for our U.S. patents since they have
expired. If we were to be granted U.S. patents in the future, the applicable authorities, including the FDA and the USPTO in the United
States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available,
and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors
may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data and
launch their product earlier than might otherwise be the case.

 For non-biologic products, loss of exclusivity
(whether by expiration of legal rights or by termination thereof as a consequence of litigation) typically results in the entry of one
or more generic competitors, leading to a rapid and severe decline in revenues, especially in the United States. Historically, outside
the United States, the market penetration of generics following loss of exclusivity has not been as rapid or pervasive as in the United
States; however, generic market penetration is increasing in many markets outside the United States, including Japan, Europe, and many
countries in the emerging markets. Moreover, patents relating to particular products, uses, formulations, or processes do not preclude
other manufacturers from employing alternative processes or marketing alternative products or formulations that compete with our patented
intellectual property.

 We may be subject to claims by third parties
asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own
intellectual property.

 We anticipate that many of the people that we
expect to hire as employees, including our one current employee, were previously employed at other pharmaceutical companies. Some of
these employees may have executed proprietary rights, non-disclosure and non-competition agreements, or similar agreements, in connection
with such previous employment. Although we try to ensure that our employees do not use the proprietary information or know-how of others
in their work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including
trade secrets or other proprietary information, of any such third-party. Litigation may be necessary to defend against such claims. If
we fail to defend any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel
or sustain damages. 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. Such a license may not be available on commercially reasonable terms
or at all. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction
to management.

 In addition, while we typically require our employees,
consultants and contractors 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, which may result in claims by or against us related to the ownership of such intellectual property. If we fail
in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights.
Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction
to our senior management and scientific personnel.

 Risks Related to Ownership of Our Common Stock

 An active public trading market for our
Common Stock may not be maintained.

 Prior to our initial public offering consummated
on January 24, 2023, there was no public market or active private market for trading shares of our Common Stock. Our Common Stock is
currently traded on the Nasdaq Capital Market, but we can provide no assurance that we will be able to maintain an active trading market.
The lack of an active market may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider
reasonable. The lack of an active market may also reduce the price of shares of Common Stock. An inactive market may impair our ability
to raise capital by selling shares and our ability to use our capital stock to acquire other companies or technologies. We cannot predict
the prices at which our Common Stock will trade.

 We cannot be assured that we will be able
to maintain our listing on the Nasdaq Capital Market.

 Our securities are listed on The Nasdaq Capital
Market, a national securities exchange. We cannot be assured that we will continue to comply with the rules, regulations or requirements
governing the listing of our Common Stock on Nasdaq Capital Market or that our securities will continue to be listed on Nasdaq Capital
Market in the future. If Nasdaq should determine at any time that we fail to meet Nasdaq requirements, we may be subject to a delisting
action by Nasdaq.

 On September 6, 2023, we received a letter from Nasdaq stating that
we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the "Rule"), requiring listed securities to maintain a minimum
bid price of $1.00 per share because our closing bid price for the last 30 consecutive business days was below $1.00 per share. On August
20, 2024 we effected a reverse stock split and on September 5, 2024 we were notified by Nasdaq that we had regained compliance with the
Rule. However, there can be no assurance that we will continue to comply with the Rule or the other Nasdaq continued listing requirements.

 If Nasdaq delists our securities from trading
on its exchange at some future date, we could face significant material adverse consequences, including:

 a
 limited availability of market quotations for our securities;

 reduced
 liquidity with respect to our securities;

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

 a
 limited amount of news and analyst coverage for our company; and

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

 Our stock price has fluctuated in the past,
has recently been volatile and may be volatile in the future, and as a result, investors in our Common Stock could incur substantial
losses.

 Investors should consider an investment in our Common Stock risky and
invest only if they can withstand a significant loss and wide fluctuations in the market value of their investment. Investors who purchase
our Common Stock may not be able to sell their shares at or above the purchase price. Our stock price has been volatile and may be volatile
in the future. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility
that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may experience
losses on their investment in our Common Stock. Some of the factors that may cause the market price of our Common Stock to fluctuate include:

 adverse
 results or delays in our clinical trials;

 the
 timing or delay of achievement of our clinical, regulatory, partnering and other milestones,
 such as the commencement of clinical development, the completion of a clinical trial, the
 receipt of regulatory approval or the establishment or termination of a commercial partnership
 for one or more of our product candidates;

 announcement
 of FDA approval or non-approval of our product candidates or delays in the FDA review process;

 actions
 taken by regulatory agencies with respect to our product candidates, our clinical trials
 or our sales and marketing activities;

 the
 commercial success of any product approved by the FDA or its foreign counterparts;

 regulatory
 developments in the United States and foreign countries;

 changes
 in the structure of healthcare payment systems;

 any
 intellectual property infringement lawsuit involving us;

 announcements
 of technological innovations or new products by us or our competitors;

 announcements related to any device used in our clinical trials;

 market
 conditions for the biotechnology or pharmaceutical industries in general;

 changes
 in financial estimates or recommendations by securities analysts;

 sales
 of large blocks of our Common Stock;

 sales
 of our Common Stock by our executive officers, directors and significant stockholders;

 direct
 sales of our Common Stock through financing arrangements;

 restatements
 of our financial results and/or material weaknesses in our internal controls;

 the
 loss of any of our key scientific or management personnel; and

 announcements
 regarding the ongoing exploration of the strategic options available to us.

 These broad market and industry factors may seriously
harm the market price of our Common Stock, regardless of our operating performance. In the past, class action litigation has often been
instituted against companies whose securities have experienced periods of volatility in market price. Any such litigation brought against
us could result in substantial costs, which would hurt our financial condition and results of operations, divert management's attention
and resources, and possibly delay our clinical trials or commercialization efforts.

 If financial or industry analysts do not
publish research or reports about our business or if they issue inaccurate or unfavorable commentary or downgrade our Common Stock, our
stock price and trading volume could decline.

 The trading market for our Common Stock will
be influenced by the research and reports that industry or financial analysts publish about us or our business. We do not control these
analysts or the content and opinions included in their reports. As a new public company, we may be slow to attract research coverage,
and the analysts who publish information about our Common Stock will have had relatively little experience with our company, which could
affect their ability to accurately forecast our results and make it more likely that we fail to meet their estimates. In the event any
of the industry or financial analysts who cover us issue an inaccurate or unfavorable opinion regarding our stock price, our stock price
would likely decline. In addition, the stock prices of many companies in the biopharmaceutical industry have declined significantly after
those companies have failed to meet, or often times failed to exceed, the financial guidance publicly announced by the companies or the
expectations of analysts. If our financial results fail to meet, or significantly exceed, our announced guidance or the expectations
of analysts or public investors, analysts could downgrade our Common Stock or publish unfavorable research about us. If one or more of
these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets,
which in turn could cause our stock price or trading volume to decline.

 Our officers and directors exercise significant
control over our Company and may be able to control our management and operations, acting in their best interests and not necessarily
those of other stockholders.

 Our executive officers and directors, in the aggregate, beneficially
own shares representing approximately 29% of our outstanding capital stock. Quang X. Pham, our Chief Executive Officer, beneficially owns
approximately 22% of our outstanding capital stock. As a result, Mr. Pham alone and together with these other stockholders, acting together,
may be able to significantly influence any matters requiring approval by our stockholders, including the election of directors, the approval
of mergers or other business combination transactions. The interests of this group of stockholders may not always coincide with our interests
or the interests of other stockholders. The significant concentration of stock ownership may adversely affect the trading price of our
Common Stock due to the perception that conflicts of interest may exist or arise. Therefore, you should not invest in reliance on your
ability to have any control over our company.

 Future sales and issuances of our Common
Stock or rights to purchase Common Stock, including pursuant to our equity incentive plans and outstanding warrants, could result in
additional dilution of the percentage ownership of our stockholders and could depress the market price of our Common Stock.

 We expect that significant additional capital
may be needed in the future to continue our planned operations, including conducting clinical trials, commercialization efforts, expanded
research and development activities and costs associated with operating a public company. To raise capital, 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, 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, preferences and privileges
senior to the holders of our Common Stock.

 Pursuant to our 2022 Successor Equity Incentive
Plan, our management is authorized to grant equity awards to our employees, officers, directors and consultants. Increases in the number
of shares available for future grant or purchase may result in additional dilution, which could cause our stock price to decline. Further,
the issuance of the shares of Common Stock underlying outstanding stock options and warrants will have a dilutive effect on the percentage
ownership held by holders of our Common Stock.

 Anti-takeover provisions in our charter
documents, and under Delaware law, could make an acquisition of our company, which may be beneficial to our stockholders, more difficult,
limit attempts by our stockholders to replace or remove our current management and limit the market price of our Common Stock.

 Provisions in our amended and restated certificate
of incorporation and amended and restated bylaws may have the effect of delaying or preventing a merger, acquisition or other change
of control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.
These provisions could also limit the price that investors might be willing to pay in the future for shares of our Common Stock, thereby
depressing the market price of our Common Stock. In addition, because our board of directors is responsible for appointing the members
of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management
by making it more difficult for stockholders to replace members of our board of directors. Among other things, our amended and restated
certificate of incorporation and amended and restated bylaws include provisions that:

 authorize
 our board of directors to issue, without further action by the stockholders, shares of undesignated
 preferred stock with terms, rights, and preferences determined by our board of directors
 that may be senior to our Common Stock;

 require
 that any action to be taken by our stockholders be effected at a duly called annual or special
 meeting and not by written consent;

 specify
 that special meetings of our stockholders can be called only by our board of directors, the
 chairperson of our board of directors, or our Chief Executive Officer;

 establish
 an advance notice procedure for stockholder proposals to be brought before an annual meeting,
 including proposed nominations of persons for election to our board of directors;

 prohibit
 cumulative voting in the election of directors;

 establish
 that our board of directors is divided into three classes — Class I, Class II, and
 Class III — with each class serving staggered three-year terms;

 provide
 that, so long as our board of directors is classified, directors may only be removed for
 cause;

 provide
 that vacancies on our board of directors may be filled only by a majority of directors then
 in office, even though less than a quorum; and

 require
 the approval of our board of directors or the holders of two-thirds of our outstanding shares
 of voting stock to amend our bylaws and certain provisions of our certificate of incorporation.

 These provisions may frustrate or prevent any
attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members
of our board of directors, which is responsible for appointing the members of our management. In addition, we are governed by the provisions
of Section 203 of the Delaware General Corporation Law, which generally, subject to certain exceptions, prohibits a Delaware corporation
from engaging in any of a broad range of business combinations with any "interested" stockholder for a period of three years
following the date on which the stockholder became an "interested" stockholder. Any of the foregoing provisions could limit
the price that investors might be willing to pay in the future for shares of our Common Stock, and they could deter potential acquirers
of our company, thereby reducing the likelihood that you would receive a premium for your shares of our Common Stock in an acquisition.

 Our amended and restated certificate of
incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware or the federal district court
for the District of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could result in increased
costs for our stockholders to bring a claim and could limit our stockholders' ability to obtain a favorable judicial forum for
disputes with us or our directors, officers or employees.

 Our amended and restated certificate of incorporation
and amended and restated bylaws provide that, unless the Company consents in writing to the selection of an alternative forum, the Court
of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court
for the District of Delaware or other state courts of the State of Delaware) is the exclusive forum for (i) any derivative action or
proceeding brought on our behalf; (ii) any action asserting a claim of breach of fiduciary duty owed by, any director, officer, employee
or agent of the Company to the Company or our stockholders; (iii) any action asserting a claim arising pursuant to any provision of the
Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws; or (iv) any
action asserting a claim against us or any director, officer of employee that is governed by the internal affairs doctrine of the law
of the State of Delaware; provided that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for
lack of subject matter jurisdiction, or the Company consents in writing to the selection of an alternative forum, such action may be
brought in another state or federal court sitting in the State of Delaware. Our amended and restated certificate of incorporation and
amended and restated bylaws also provide that the federal district courts of the United States of America is the exclusive forum for
the resolution of any complaint asserting a cause of action arising under the Securities Act. Notwithstanding the foregoing, the exclusive
forum provision will not apply to claims brought to enforce any liability or duty created by the Exchange Act. Nothing in our amended
and restated certificate of incorporation or amended and restated bylaws preclude stockholders that assert claims under the Exchange
Act from bringing such claims in state or federal court, subject to applicable law.

 We believe these provisions may benefit us by
providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable,
particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to
other forums and protection against the burdens of multi-forum litigation. However, this choice of forum provision could result in increased
costs for our stockholders to bring a claim and could may limit a stockholder's ability to bring a claim in a judicial forum that
it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits
with respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws
and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies'
certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisions
to be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid,
a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there
can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choice
of forum provision that is contained in our amended and restated certificate of incorporation and amended and restated bylaws to be inapplicable
or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could
adversely affect our business and financial condition.

 Claims for indemnification by our directors
and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available
to us.

 Our amended and restated bylaws, provide that
we will indemnify our directors and executive officers, in each case to the fullest extent permitted by Delaware law.

 In addition, as permitted by Section 145 of the
DGCL, our amended and restated bylaws and the indemnification agreements that we have entered into with each of our current executive
officers and intend to enter into with our directors and certain other officers, among other things provide that:

 We
 will indemnify our directors and executive officers for serving us in those capacities, or
 for serving as a director, officer, employee or agent of other business enterprises at our
 request, to the fullest extent permitted by Delaware law. Delaware law provides that we may
 indemnify such person if such person acted in good faith and in a manner such person reasonably
 believed to be in or not opposed to our best interest and, with respect to any criminal proceeding,
 had no reasonable cause to believe such person's conduct was unlawful.

 We
 may, in our discretion, indemnify employees and agents in those circumstances where indemnification
 is permitted by applicable law.

 We
 will be required to advance expenses, as incurred, to our directors and officers in connection
 with defending a proceeding, except that such directors or officers shall undertake to repay
 such advances if it is ultimately determined that such person is not entitled to indemnification.

 The
 rights conferred in our bylaws will not be exclusive. We may not retroactively amend our
 bylaw provisions to reduce our indemnification obligations to directors, officers, employees
 and agents.

 As a result, claims for indemnification by our
directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of
money available to us.

 We do not intend to pay dividends in the
foreseeable future. As a result, your ability to achieve a return on your investment will depend on appreciation in the price of our
Common Stock.

 We have never declared or paid any cash dividends
on our Common Stock. We currently intend to retain all available funds and any future earnings for use in the operation of our business
and do not anticipate paying any dividends on our Common Stock in the foreseeable future. Any determination to pay dividends in the future
will be at the discretion of our board of directors. Consequently, your only opportunity to achieve a return on your investment in our
company will be if the market price of our Common Stock appreciates and you sell your shares at a profit. There is no guarantee that
the price of our Common Stock that will prevail in the market will ever exceed the price that you pay. For additional information about
our dividend policy, see the "Dividend Policy" in Part II, Item 5 of this Annual Report.

 Certain members of our management team
have limited experience managing a public company.

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

 We have incurred significant increased
costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.

 As a public company, we have incurred and will
continue to incur legal, accounting and other expenses that we did not incur as a private company. We are subject to the reporting requirements
of the Securities Exchange Act, and are required to comply with the applicable requirements of the Sarbanes-Oxley Act of 2002, or SOX,
and the Dodd-Frank Wall Street Reform and Consumer Protection Act, or Dodd-Frank. The listing requirements of the Nasdaq Stock Market,
and the rules of the SEC require that we satisfy certain corporate governance requirements. Our management and other personnel are required
to devote a substantial amount of time to ensure that we comply with all of these requirements. Moreover, the reporting requirements,
rules and regulations have increased our legal and financial compliance costs and will make some activities more time-consuming and costly.
Any changes we make to comply with these obligations may not be sufficient to allow us to satisfy our obligations as a public company
on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation
exposure associated with being a public company, could also make it more difficult for us to attract and retain qualified persons to
serve on our board of directors or board committees or to serve as executive officers, or to obtain certain types of insurance, including
directors' and officers' insurance, on acceptable terms.

 As a public company, we are required to maintain internal control over
financial reporting and to report any material weaknesses in such internal controls. Section 404 requires an annual management assessment
of the effectiveness of our internal control over financial reporting. The rules governing the standards that must be met for management
to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation.

 To date, we have not identified any material
weaknesses in our review of our internal controls for the purpose of providing the reports required by these rules. In the future, if
we identify material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements of
Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to assert that our internal control over financial reporting
is effective, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our Common
Stock could decline, and we could also become subject to investigations by the stock exchange on which our Common Stock is listed, the
SEC or other regulatory authorities, which could require additional financial and management resources. In addition, as a public company
we are required to file accurate and timely quarterly and annual reports with the SEC under the Exchange Act. Any failure to report our
financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from Nasdaq or other adverse
consequences that would materially harm our business and reputation.

 For so long as we remain an emerging growth company
as defined in the JOBS Act, we intend to take advantage of certain exemptions from various reporting requirements that are applicable
to public companies that are not emerging growth companies, including, but not limited to, not being required to comply with the auditor
attestation requirements of Section 404. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal
year (i) following the fifth anniversary of the completion of our initial public offering, (ii) in which we have total annual gross revenue
of at least $1.235 billion, or (iii) in which we are deemed to be a large accelerated filer, which means the market value of our Common
Stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30 th, and (2) the date on which we have issued
more than $1.0 billion in non-convertible debt during the prior three-year period.

 We are an emerging growth company and we
cannot be certain if (i) the reduced disclosure requirements or (ii) extended transition periods for complying with new or revised accounting
standards applicable to emerging growth companies will make our Common Stock less attractive to investors. In addition, as a smaller
reporting company we will also have reduced disclosure requirements.

 We qualify as an emerging growth company. Under
the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply
to private companies. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent
to the enactment of the JOBS Act until such time as those standards apply to private companies. We have elected to use this extended
transition period for complying with new or revised accounting standards that have different effective dates for public and private companies
until the earlier of the date we (i) are no longer an emerging growth company, or (ii) affirmatively and irrevocably opt out of the extended
transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with
new or revised accounting pronouncements as of public company effective dates.

 In addition, for as long as we continue to be
an emerging growth company, we intend to take advantage of certain exemptions from various reporting requirements that are applicable
to other public companies including, but not limited to, 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. We cannot predict if investors will find our Common Stock
less attractive because we will 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 are also a "smaller reporting company"
as defined in the Securities Exchange Act, and have elected to take advantage of certain of the scaled disclosures available to smaller
reporting companies. To the extent that we continue to qualify as a "smaller reporting company" as such term is defined in
Rule 12b-2 under the Exchange Act, after we cease to qualify as an emerging growth company, certain of the exemptions available to us
as an "emerging growth company" may continue to be available to us as a "smaller reporting company," including
exemption from compliance with the auditor attestation requirements pursuant to SOX and reduced disclosure about our executive compensation
arrangements. We will continue to be a "smaller reporting company" until we have $250 million or more in public float (based
on our Common Stock) measured as of the last business day of our most recently completed second fiscal quarter or, in the event we have
no public float (based on our Common Stock) or a public float (based on our Common Stock) that is less than $700 million, annual revenues
of $100 million or more during the most recently completed fiscal year.

 We have additional securities available
for issuance, which, if issued, could adversely affect the rights of the holders of our Common Stock.

 Our Amended and Restated Certificate of Incorporation, as amended, authorizes
the issuance of 75,000,000 shares of our Common Stock and 7,500,000 shares of preferred stock. We currently have 1,879,710 shares of Common
Stock outstanding, options exercisable to purchase 436,334 shares of Common Stock, and 615,940 warrants exercisable to purchase shares
of Common Stock. In certain circumstances, the Common Stock, as well as the awards available for issuance under our equity incentive plans
and shares of preferred stock, can be issued by our board of directors, without stockholder approval. Any future issuances of such stock
would further dilute the percentage ownership of us held by holders of preferred stock and Common Stock. In addition, the issuance of
certain securities, including pursuant to the terms of our stockholder rights plan, may be used as an "anti-takeover" device
without further action on the part of our stockholders, and may adversely affect the holders of the Common Stock.

 Future sales of our Common Stock could
cause the market price for our Common Stock to decline.

 We cannot predict the effect, if any, that market
sales of shares of our Common Stock or the availability of shares of our Common Stock for sale will have on the market price of our Common
Stock prevailing from time to time. Sales of substantial amounts of shares of our Common Stock in the public market, or the perception
that those sales will occur, could cause the market price of our Common Stock to decline or be depressed.

 There is no public market for the outstanding warrants.

 There is no established public trading market
for any outstanding warrants and we do not expect a market to develop. None of our warrants are listed on a national securities exchange
or other nationally recognized trading system. Without an active market, the liquidity of the warrants will be limited.

 Holders of the outstanding warrants will
have no rights as common stockholders with respect to the shares our Common Stock underlying the warrants until such holders exercise
their warrants and acquire our Common Stock, except as otherwise provided in the warrants.

 Until holders of the outstanding warrants acquire
shares of our Common Stock upon exercise thereof, such holders will have no rights with respect to the shares of our Common Stock underlying
such warrants, except to the extent stated in the warrant. Upon exercise of the warrants, the holders will be entitled to exercise the
rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

 Item 1B. Unresolved Staff Comments.

 None.

 Item 1C. Cybersecurity.

 We maintain a cyber risk management protocol
designed to identify, assess, manage, mitigate, and respond to cybersecurity threats.

 The underlying processes and controls of our
cyber risk management protocol incorporate recognized best practices and standards for cybersecurity and information technology, including
the National Institute of Standards and Technology ("NIST") Cybersecurity Framework ("CSF"). We have undertaken,
on an annual basis, to conduct an assessment of our cyber risk management processes and controls to identify, quantify, and categorize
material cyber risks. In addition, we have developed a risk mitigation plan to address such risks, and where necessary, remediate potential
vulnerabilities identified through the annual assessment process.

 In addition, we maintain policies over areas
such as information security, access on/offboarding, and access and account management, to help govern the processes put in place by
management designed to protect our IT assets, data, and services from threats and vulnerabilities. We consult with a third-party specialist
with regard to our cyber risk management processes and controls.

 Our management team is responsible for oversight
and administration of our cyber risk management protocol, and for informing senior management and other relevant stakeholders regarding
the prevention, detection, mitigation, and remediation of cybersecurity incidents. Cadrenal's management team has prior experience
selecting, deploying, and overseeing cybersecurity technologies, initiatives, and processes and relies on threat intelligence as well
as other information obtained from governmental, public, or private sources. Our Audit Committee also provides oversight of risks from
cybersecurity threats.

 As part of its review of the adequacy of our
system of internal controls over financial reporting and disclosure controls and procedures, the Audit Committee is specifically responsible
for reviewing the adequacy of our computerized information system controls and security related thereof. The cybersecurity stakeholders,
including member(s) of management assigned with cybersecurity oversight responsibility and/or third-party consultants providing cyber
risk services, brief the Audit Committee on cyber vulnerabilities identified through the risk management process, the effectiveness of
our cyber risk management program, and the emerging threat landscape and new cyber risks on at least an annual basis. This includes updates
on Cadrenal's processes to prevent, detect, and mitigate cybersecurity incidents. In addition, cybersecurity risks are reviewed
by our Board of Directors at least annually, as part of the Company's corporate risk oversight processes.

 We face risks from cybersecurity threats that
could have a material adverse effect on our business, financial condition, results of operations, cash flows or reputation. Cadrenal
acknowledges that the risk of cyber incidents is prevalent in the current threat landscape and that a future cyber incident may occur
in the normal course of its business. To date, we have not had a cybersecurity incident. We proactively seek to detect and investigate
unauthorized attempts and attacks against our IT assets, data, and services, and to prevent their occurrence and recurrence where practicable
through changes or updates to internal processes and tools and changes or updates to service delivery; however, potential vulnerabilities
to known or unknown threats will remain. Further, there is increasing regulation regarding responses to cybersecurity incidents, including
reporting to regulators, investors, and additional stakeholders, which could subject us to additional liability and reputational harm.
See Item 1A. "Risk Factors" for more information on cybersecurity risks.

 Item 2. Properties.

 Our corporate headquarters are located at 822 A1A North, Suite 306,
Ponte Vedra, Florida 32082, which are leased pursuant to an amended Lease Agreement dated October 21, 2024 with Veranda III Partners,
Ltd. (the "Lease Agreement"). The Lease Agreement has a term of 12 months commencing on November 1, 2024. The monthly
rent is $2,274. We believe that these headquarters are adequate for our current operations and needs.

 Item 3. Legal Proceedings.

 We are not currently a party to any material
legal proceedings. We may, however, in the ordinary course of business face various claims brought by third parties, and we may, from
time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating
to employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation. If this
were to happen, the payment of any such awards could have a material adverse effect on our business, financial condition and results
of operations. Additionally, any such claims, whether or not successful, could damage our reputation and business.

 Item 4. Mine Safety Disclosures.

 Not applicable.

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

 Market Information

 Our Common Stock has traded on the Nasdaq Capital Market under the
symbol "CVKD" since January 20, 2023. The last price of our Common Stock as reported on the Nasdaq Capital Market on March
12, 2025 was $17.67 per share.

 Stockholders

 We have two classes of stock, undesignated preferred stock, par value
$0.001 per share, and Common Stock, par value $0.001 per share. No shares of preferred stock have been issued or are outstanding. As of
March 13, 2025, we had 20 Common Stock stockholders of record. The number of holders of record is based on the actual number of holders
registered on the books of our transfer agent and does not reflect holders of shares in "street name" or persons, partnerships,
associations, corporations or other entities identified in security position listings maintained by depository trust companies.

 Dividend Policy

 We have never paid any cash dividends on our Common
Stock to date, and do not anticipate paying such cash dividends in the foreseeable future. Whether we declare and pay dividends is determined
by our Board of Directors at their discretion, subject to certain limitations imposed under Delaware corporate law. The timing, amount
and form of dividends, if any, will depend on, among other things, our results of operations, financial condition, cash requirements and
other factors deemed relevant by our Board of Directors.

 Equity Compensation Plan Information

 The Company adopted the Cadrenal Therapeutics, Inc. 2022 Equity Incentive
Plan, (the "Initial Plan"), on July 11, 2022, which was later amended and restated on October 16, 2022, for purposes
of clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment and restatement of
the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the "Successor
Plan") for the issuance and approval of awards after consummation of our initial public offering. On October 16, 2022, the
Board adopted and the Company's stockholders approved the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the
"2022 Plan"), which is a successor to and continuation of the Initial Plan. The 2022 Plan became effective on January 19,
2023, at which time it replaced the Initial Plan, except with respect to awards outstanding under the Initial Plan. No further awards
are available for grant under the Initial Plan.

 The following table presents information as of
December 31, 2024 with respect to shares of our Common Stock that may be issued under our existing equity compensation plans.

 Plan Category

 Securities
 to be Issued
 upon
 of
 Equity

 Plan Options

 Weighted-
 Average
 Price of
 Equity

 Plan Options

 Securities
 Remaining
 Available for
 Future
 Issuance
 Under Equity
 Plans
 (excluding
 securities
 reflected in
 the first
 column)

 Equity compensation plans approved by security holders

 $
 13.20

 147,303

 Equity compensation plans not approved by security holders

 -

 -

 -

 Total

 $
 13.20

 147,303

 2022 Successor Equity Incentive Plan

 See "Equity Incentive Plans—2022 Successor
Equity Incentive Plan" in Part III, Item 11 for a description of the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive
Plan.

 Recent Sales of Unregistered Securities

 We have not issued unregistered securities to any person during the
year ended December 31, 2024 and up to the date of the filing of this Annual Report in transactions that were not previously disclosed
in our filings with the SEC other than as set forth below.

 On January 8, 2025, we issued 25,000 shares of
restricted Common Stock to a consultant as partial compensation for services.

 Use of Proceeds

 All proceeds received from our initial public
offering have been used as planned use of proceeds from our initial public offering as described in our final prospectus filed with the
SEC on January 23, 2023.

 Item
6. [Reserved]

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

 The following discussion of our financial condition
and results of operations should be read in conjunction with the audited financial statements and notes thereto for the period ended
December 31, 2024 found in this Annual Report. In addition to historical information, the following discussion contains forward-looking
statements that involve risks, uncertainties and assumptions. Where possible, we have tried to identify these forward-looking statements
by using words such as "may," "should," "potential," "continue," "expects,"
"anticipates," "intends," "plans," "believes," "estimates," and similar expressions.
Our actual results could differ materially from those anticipated by the forward-looking statements due to important factors and risks
including, but not limited to, those set forth under "Risk Factors" in Part I, Item 1A of this Annual Report.

 Company Overview

 We are developing tecarfarin, our drug candidate, for
unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) designed
to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions requiring chronic anticoagulation.

 There is a lack of approved anticoagulation therapies
for certain rare cardiovascular conditions requiring chronic anticoagulation, such as patients with left ventricular assist devices (LVADs),
patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with catastrophic or thrombotic anti-phospholipid
syndrome (APS). For patients with these conditions, treatment guidelines, and not FDA-approved labeling, recommended the use of a vitamin
K antagonist (VKA) such as warfarin, despite warfarin's acknowledged challenges in achieving sufficiently stable and reliable anticoagulation
in these patients. Additionally, direct-acting oral anticoagulants (DOACs) like Eliquis and Xarelto have either not shown clinical benefits
in these and certain other patient populations, or their efficacy and safety remain uncertain.

 At the time the initial investigational new drug
(IND) application for tecarfarin was filed by its initial sponsor, warfarin was the only marketed oral anticoagulant, and the strategy
was to develop tecarfarin as an alternative VKA with superior efficacy and safety over warfarin for a broad range of indications including
AFib, deep vein thrombosis (DVT), pulmonary embolism (PE), prevention of pulmonary embolism in patients with venous thrombosis, DVT prevention
in patients undergoing certain surgical procedures, thrombosis prevention in patients with mechanical heart valves, and prevention of
thrombotic complications in patients after a myocardial infarction (heart attack), among others.

 While tecarfarin clinical trials were being conducted
by the initial IND sponsor, the DOACs were advancing through clinical trials and ultimately approved after demonstrating that they were
non-inferior to warfarin in certain indications, including AFib in the general population, prevention of pulmonary embolism in patients
with venous thrombus, and prevention of deep vein thrombosis in patients undergoing certain surgical procedures, among others. These DOAC
clinical studies resulted in a change in the standard of care for a large percentage of the population that had been previously treated
with warfarin, and some of the same population that was initially targeted by prior tecarfarin IND sponsor. Thus, the original broad-label
development plan for tecarfarin became much more challenging.

 Accordingly, we are focusing the development of
tecarfarin for rare cardiovascular conditions where patients are unable to achieve sufficiently reliable chronic anticoagulation with
warfarin, and where DOACs have either failed or their efficacy and safety remain unproven. These include patients with LVADs, patients
with ESKD and AFib, patients with mechanical heart valves and ESKD or resistant to warfarin, and patients with catastrophic or thrombotic
APS, among others, where the need for VKA-dependent chronic anticoagulation has been underscored by recent clinical studies. While warfarin-treated
patients have fared better than DOAC-treated patients in comparative studies in certain of these cardiovascular conditions, the event
rates in these studies remain unacceptably high and the quality of anticoagulation in warfarin-treated patients has repeatedly been shown
to be sub-optimal – hence, there continues to be unmet medical needs surrounding the use of warfarin in these patients that are
not addressed – or not addressable - by DOACs.

 Tecarfarin has an orphan drug designation from
the FDA for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support
device, which includes left ventricular assist device (LVAD), a heart pump. Tecarfarin also has orphan drug and fast-track designations
from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial
fibrillation (AFib).

 Tecarfarin has been evaluated in eleven (11) human
clinical trials in over 1,000 individuals; (269 patients were treated for at least six months and 129 patients were treated for one year
or more). In Phase 1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects
and patients with chronic kidney disease (CKD). In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having
completed it, including those with mechanical heart valves, only 1.6% of the blinded tecarfarin subjects suffered from major bleeding
and there were no thrombotic events.

 Private Placement

 On July 12, 2023, we entered into a securities
purchase agreement (the "Purchase Agreement") with an institutional investor (the "Investor") pursuant to which
we sold to the Investor in a private placement priced at-the-market (the "Private Placement") consistent with the rules of
the Nasdaq), (i) an aggregate of 86,667 shares of Common Stock, (ii) in lieu of additional share of Common Stock, pre-funded warrants
(the "Pre-Funded Warrants") to purchase up to an aggregate of 199,047 shares of Common Stock, and (iii) accompanying common
warrants (the "Common Warrants") to purchase up to an aggregate of 285,715 shares of Common Stock. The combined purchase price
of each share and accompanying Common Warrants was $26.25. The combined purchase price of each Pre-Funded Warrant and accompanying Common
Warrants was $26.25.

 The Private Placement closed on July 14, 2023.
We received aggregate gross proceeds from the Private Placement of approximately $7.5 million before deducting the placement agent commissions
and estimated offering expenses payable by us. H.C. Wainwright & Co., LLC ("H.C.W.") acted as the placement agent in the
Private Placement, and as part of its compensation, we issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571
shares of Common Stock.

 Warrant Inducement

 On November 1, 2024, we entered into a warrant inducement letter agreement
(the "Warrant Inducement Agreement") with a holder (the "Holder") of outstanding warrants (the "Existing
Warrants") to purchase up to 285,715 shares of Common Stock (the "Existing Warrant Shares") issued in a private placement
offering on July 14, 2023 pursuant to which such holder exercised the Existing Warrants at a reduced exercise price of $16.50 generating
approximately $4.7 million in gross proceeds. In consideration of the Holder's agreement to exercise the Existing Warrants (the
"Warrant Exercise") in accordance with the Warrant Inducement Agreement, we issued to the Holder new unregistered Series A-1
Common Stock purchase warrants to purchase an aggregate of 285,715 shares of Common Stock, equal to 100% of the number of Existing Warrant
Shares issued upon exercise of the Existing Warrants and new unregistered Series A-2 Common Stock purchase warrants to purchase an aggregate
of 285,715 shares of Common Stock, equal to 100% of the number of Existing Warrant Shares issued upon exercise of the Existing Warrants,
at an exercise price of $16.50 per share.

 ATM Facility

 During the year ended December 31, 2024, we sold
391,243 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W., generating gross proceeds of approximately $5.1
million and net proceeds of approximately $4.8 million.

 From January 1, 2025 through March 13, 2025, we
sold 72,224 shares of our Common Stock through our at-the-market (ATM) facility with H.C.W. These sales were made at a weighted average
price of $20.29 per share, resulting in total gross proceeds of approximately $1,466,000 and net proceeds of approximately $1,419,000.

 Results of Operations

 The following table summarizes our results of
operations for the fiscal year ended December 31, 2024 and 2023.

 2024

 2023

 Change

 Operating expenses:

 General and administrative expenses

 $
 6,753,726

 $
 3,549,516

 $
 3,204,210

 Research and development expenses

 4,205,013

 4,081,347

 123,666

 Depreciation expense

 1,880

 1,980

 (100
)

 Total operating expenses

 10,960,619

 7,632,843

 3,327,776

 Loss from operations

 (10,960,619
)

 (7,632,843
)

 (3,327,776
)

 Other (income) expense:

 Interest and dividend income

 (309,251
)

 (249,092
)

 (60,159
)

 Interest expense

 -

 3,534

 (3,534
)

 Interest expense, amortization of debt discount

 -

 13,567

 (13,567
)

 Change in fair value of derivative liabilities

 -

 216,095

 (216,095
)

 Loss on extinguishment of debt

 -

 740,139

 (740,139
)

 Total other (income) expense

 (309,251
)

 724,243

 (1,033,494
)

 Net loss and comprehensive loss

 $
 (10,651,368
)

 $
 (8,357,086
)

 $
 (2,294,282
)

 General and administrative expenses

 General and administrative expenses for the years
ended December 31, 2024, and 2023 were $6.8 million and $3.5 million, respectively, representing an increase of approximately $3.2 million,
or 90%. The increase can be primarily attributed to a $0.9 million increase in personnel-related expenses as we hired a Chief Operating
Officer in February 2024 as well as annual pay raises for management in January 2024, a $1.4 million increase in expenses related to being
a public company, a $0.7 million increase in stock-based compensation, and a $0.2 million increase in other general and administrative
expenses.

 Research and development expenses

 Research and development expenses for the years
ended December 31, 2024, and 2023 were $4.2 million and $4.1 million, respectively, representing an increase of $0.1 million, or 3%. The
prior year included a $3.0 million expense for the issuance of 40,000 shares of Common Stock (valued at $3.0 million) in January 2023
to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement. Excluding the $3.0 million stock issuance expense
in 2023, research and development expenses increased $3.1 million in 2024 compared to 2023 due to a $1.9 million increase in expenses
associated with chemistry, manufacturing, and controls ("CMC"), a $1.0 million increase in consulting fees, and a $0.1 million
increase in personnel-related expenses.

 Interest and dividend income

 Interest and dividend income for the years ended December
31, 2024, and 2023 were $0.3 million and $0.2 million, respectively. This represents the interest and dividend income earned from our
investments in money market funds. The increase in interest and dividend income in the current years can be attributed to higher balances
in money market funds.

 Change in fair value of derivative
liabilities

 Concurrent with the closing of the IPO in January
2023, note holders converted debt into Common Stock, and accordingly, the derivative financial liabilities were de-recognized and reclassified
to stockholders' equity on January 24, 2023.

 The derivative liabilities were considered a level
3 fair value financial instrument and were remeasured up to January 24, 2023, which was the date of derecognition. We recorded a non-cash
charge of $0.2 million in January 2023. This charge represented the increase in the fair value of the derivative liabilities since the
previous measurement date of December 31, 2022. We did not have such activity during the year ended December 31, 2024.

 Loss on extinguishment of debt

 We recorded a $0.7 million loss on the
extinguishment of debt during the year ended December 31, 2023. This loss represented the unamortized debt discount associated with
the convertible notes and the November promissory notes, which were settled concurrent with the IPO. We did not have such activity
during the year ended December 31, 2024.

 Liquidity and Capital Resources

 Since inception, we have incurred losses and utilized
cash in operations. To date, we have funded our operations from the proceeds of the sale of convertible and promissory notes, our IPO
completed in January 2023, our Private Placement completed in July 2023, our Warrant Inducement completed in November 2024, and the sale
of Common Stock through our ATM facility. We recognized a net loss of $10.7 million for the year ended December 31, 2024 which included
$1.4 million of non-cash expenses. Cash used in operating activities for the year ended December 31, 2024 totaled $7.4 million. As of
March 13, 2025, we had cash and cash equivalents of approximately $7.9 million, which is expected to be sufficient to fund our operations
for at least the next twelve months from the date of the filing of this Annual Report on Form 10-K, however, we will require additional
funding to complete our planned Phase 3 clinical trial and submit our NDA.

 Cash Flows

 The following table summarizes our cash flow for the period presented:

 Years Ended December 31,

 2024

 2023

 Cash used in operating activities

 $
 (7,357,550
)

 $
 (3,530,323
)

 Cash used in investing activities

 (6,537
)

 (3,254
)

 Cash provided by financing activities

 8,979,529

 11,903,491

 Net increase in cash

 1,615,442

 8,369,914

 Cash and cash equivalents, beginning of period

 32,586

 Cash and cash equivalents, end of period

 $
 10,017,942

 $

 Operating activities

 During the year ended December 31, 2024, cash
used in operating activities was $7.4 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used
$9.2 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $1.9 million
in cash primarily from a $1.3 million increase in accounts payable and a $0.5 million increase in accrued liabilities.

 During the year ended December 31, 2023, cash
used in operating activities was $3.5 million. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used
$3.7 million in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $0.1 million
in cash primarily from a $0.7 million decrease in deferred equity offering costs, partially offset by a decrease in accrued liabilities
of $0.2 million and a decrease in accounts payable of $0.2 million.

 Financing activities

 During the year ended December 31, 2024, net cash
provided by financing activities totaled $9.0 million, comprised of net proceeds from our ATM facility of $4.8 million and net proceeds
from our Warrant Inducement Agreement of $4.2 million.

 During the year ended December 31, 2023, net cash
provided by financing activities totaled $11.9 million as we completed our IPO in January 2023, generating net proceeds of $5.4 million,
and we completed a private placement financing in July 2023, generating net proceeds of $6.5 million. We also received $0.3 million from
the exercise of warrants that we issued in November 2022, which proceeds were used to repay the notes that were issued in November 2022.

 Critical Accounting Estimates

 This discussion and analysis of our financial
condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted
accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates
and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at
the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Significant estimates and
assumptions made in the accompanying financial statements include but are not limited to the fair value of financial instruments, the
fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. Our estimates
are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results
of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimated under different assumption or conditions.

 Stock-Based Compensation

 We measure our stock-based awards granted to employees,
consultants and directors based on the estimated grant-date fair values of the awards and recognize the compensation over the requisite
service period. We use the Black-Scholes option-pricing model to estimate the fair value of our stock option awards. Stock-based compensation
is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is
reduced by forfeitures. We account for forfeitures as they occur.

 OFF-BALANCE SHEET ARRANGEMENTS

 We did not have during the periods presented,
and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

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

 Not applicable because we are a smaller reporting
company.

 Item 8. Financial Statements and Supplementary Data.

 FINANCIAL STATEMENTS

 Contents

 INDEX TO FINANCIAL STATEMENTS

 Page

 Report of Independent Registered Public Accounting Firm (PCAOB ID #100)

 Balance Sheets at December 31, 2024 and 2023

 Statements of Operations and Comprehensive Loss for the Years ended December 31, 2024 and 2023

 Statements of Changes in Stockholders' Equity for the Years ended December 31, 2024 and 2023

 Statements of Cash Flows for the Years ended December 31, 2024 and 2023

 Notes to Financial Statements

 F- 1

 Report of Independent Registered Public Accounting
Firm

 Board of Directors and Stockholders of

 Cadrenal Therapeutics, Inc.:

 Opinion on the Financial Statements

 We have audited the accompanying balance sheets
of Cadrenal Therapeutics, Inc. (the "Company") as of December 31, 2024 and 2023, and the related statements of operations
and comprehensive loss, changes in stockholders' equity, and cash flows for the years ended December 31, 2024 and 2023, and the
related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly,
in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and
its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

 Basis for Opinion

 These financial statements are the responsibility
of the Company's management. Our responsibility is to express an opinion on these 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/ WithumSmith+Brown, PC

 We have served as Company's auditor since 2022.

 East Brunswick, New Jersey

 PCAOB ID No. 100

 F- 2

 BALANCE SHEETS

 2024

 2023

 Assets:

 Current assets:

 Cash and cash equivalents

 $
 10,017,942

 $

 Interest receivable

 38,153

 37,248

 Prepaid expenses and other current assets

 42,257

 52,425

 Deferred offering costs

 14,445

 -

 Total current assets

 10,112,797

 8,492,173

 Property, plant and equipment, net

 6,944

 2,287

 Right of use assets

 -

 20,998

 Other assets

 3,792

 3,792

 Total assets

 $
 10,123,533

 $
 8,519,250

 Liabilities and Stockholders' Equity:

 Current liabilities:

 Accounts payable

 $
 1,502,468

 $
 167,319

 Accrued liabilities

 1,181,490

 638,206

 Operating lease liability

 -

 21,350

 Total current liabilities

 2,683,958

 826,875

 Total liabilities

 2,683,958

 826,875

 Stockholders' equity:

 Preferred stock, $ 0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding at December 31, 2024 and December 31, 2023

 -

 -

 Common stock, $ 0.001 par value; 75,000,000 shares authorized, 1,782,486 shares issued and outstanding as of December 31, 2024; 868,184 shares issued and outstanding as of December 31, 2023 (1)

 1,782

 Additional paid-in capital (1)

 33,160,576

 22,762,922

 Accumulated deficit

 ( 25,722,783
)

 ( 15,071,415
)

 Total stockholders' equity

 7,439,575

 7,692,375

 Total liabilities and stockholders' equity

 $
 10,123,533

 $
 8,519,250

 (1)
 All share and per share information has been retroactively adjusted
to reflect the 1-for-15 reverse stock split effected on August 20, 2024. See Note 6, Stockholders' Equity for additional information.

 The accompanying notes are an integral part
of these financial statements.

 F- 3

 STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 Years Ended

 2024

 2023

 Operating expenses:

 General and administrative expenses

 $
 6,753,726

 $
 3,549,514

 Research and development expenses

 4,205,013

 4,081,349

 Depreciation expense

 1,880

 1,980

 Total operating expenses

 10,960,619

 7,632,843

 Loss from operations

 ( 10,960,619
)

 ( 7,632,843
)

 Other (income) expense:

 Interest and dividend income

 ( 309,251
)

 ( 249,092
)

 Interest expense

 -

 3,534

 Interest expense, amortization of debt discount

 -

 13,567

 Change in fair value of derivative liabilities

 -

 216,095

 Loss on extinguishment of debt

 -

 740,139

 Total other (income) expense

 ( 309,251
)

 724,243

 Net loss and comprehensive loss

 $
)

 $
)

 Net loss per common share, basic and diluted (1)

 $
 ( 8.73
)

 $
 ( 9.29
)

 Weighted average number of common shares used in computing net loss per common share, basic and diluted (1)

 1,219,550

 899,465

 (1)
 All share and per share information has been retroactively adjusted
to reflect the 1-for-15 reverse stock split effected on August 20, 2024. See Note 6, Stockholders' Equity for additional information.

 The accompanying notes are an integral part
of these financial statements.

 F- 4

 STATEMENTS OF CHANGES IN STOCKHOLDERS'
EQUITY

 For the Year Ended December 31, 2024

 Additional

 Total

 Common Stock (1)

 Paid-In

 Accumulated

 Stockholders'

 Shares

 Amount

 Capital (1)

 Deficit

 Equity

 Balance, December 31, 2023

 868,184

 $

 $
 22,762,922

 $
 ( 15,071,415
)

 $
 7,692,375

 Issuance of common shares from exercise of pre-funded warrants

 199,047

 -

 Rounding of fractional shares from reverse stock split

 ( 36
)

 -

 -

 -

 -

 Equity-based compensation - options

 -

 -

 747,005

 -

 747,005

 Issuance of common stock for consulting services

 38,333

 671,996

 -

 672,034

 Proceeds from sale of common stock, net issuance costs of $ 337,639

 391,243

 4,805,564

 -

 4,805,955

 Proceeds from warrant inducements, net of issuance costs of $ 541,022

 4,172,990

 -

 4,173,276

 Net loss

 -

 -

 -

)

)

 Balance, December 31, 2024

 1,782,486

 $
 1,782

 $
 33,160,576

 $
 ( 25,722,783
)

 $
 7,439,575

 For the Year Ended December 31, 2023

 Total

 Additional

 Stockholders'

 Common Stock (1)

 Paid-In

 Accumulated

 Equity

 Shares

 Amount

 Capital (1)

 Deficit

 (Deficit)

 Balance, December 31, 2022

 546,258

 $

 $
 1,162,633

 $
 ( 6,714,329
)

 $
 ( 5,551,150
)

 Issuance of common shares in initial public offering, net of offering costs

 93,333

 5,408,482

 -

 5,408,575

 Issuance of common shares to settle convertible debt

 76,047

 1,140,624

 -

 1,140,700

 De-recognition of derivative liabilities

 -

 -

 4,596,039

 -

 4,596,039

 Issuance of common shares, pre-funded warrants and warrants in private placement, net of fees

 86,667

 6,494,829

 -

 6,494,916

 Issuance of common shares from exercise of warrants

 16,667

 249,983

 -

 250,000

 Issuance of common shares to settle asset purchase obligation

 40,000

 2,999,960

 -

 3,000,000

 Issuance of restricted common shares for consulting services

 5,156

 108,271

 -

 108,276

 Equity-based compensation - options, restricted stock and RSUs

 4,056

 602,101

 -

 602,105

 Net loss

 -

 -

 -

)

)

 Balance, December 31, 2023

 868,184

 $

 $
 22,762,922

 $
 ( 15,071,415
)

 $
 7,692,375

 (1)
 All share and per share information has been retroactively adjusted
to reflect the 1-for-15 reverse stock split effected on August 20, 2024. See Note 6, Stockholders' Equity for additional information.

 The accompanying notes are an integral part
of these financial statements.

 F- 5

 STATEMENTS OF CASH FLOWS

 Years Ended

 2024

 2023

 Cash flows from operating activities:

 Net loss

 $
)

 $
)

 Adjustments to reconcile net loss to net cash used in operating activities:

 Depreciation expense

 1,880

 1,980

 Equity-based compensation

 1,419,039

 710,381

 Amortization of debt discount

 -

 13,567

 Change in fair value of derivative liabilities

 -

 216,095

 Loss on extinguishment of debt

 -

 740,139

 Non-cash lease expense

 ( 352
)

 Issuance of shares to settle asset purchase agreement

 -

 3,000,000

 Changes in operating assets and liabilities:

 Interest receivable

 ( 905
)

 ( 37,248
)

 Prepaid expenses

 10,168

 ( 29,710
)

 Deferred offering costs

 ( 14,445
)

 672,295

 Other assets

 -

 2,195

 Accounts payable

 1,335,149

 ( 237,578
)

 Accrued liabilities

 543,284

 ( 225,645
)

 Net cash used in operating activities

 ( 7,357,550
)

 ( 3,530,323
)

 Cash flows used in investing activities:

 Investment in property and equipment

 ( 6,537
)

 ( 3,254
)

 Net cash used in investing activities

 ( 6,537
)

 ( 3,254
)

 Cash flows from financing activities:

 Proceeds from sale of common stock, pre-funded warrants and warrants in private placement, net of fees

 -

 6,494,916

 Proceeds from warrant inducements

 4,714,298

 -

 Issuance costs from warrant inducement

 ( 541,022
)

 -

 Proceeds from sale of common stock

 5,143,594

 -

 Issuance costs from sale of common stock

 ( 337,639
)

 -

 Proceeds from exercise of warrants

 250,000

 Repayment of promissory notes

 -

 ( 250,000
)

 Proceeds from sale of common stock in initial public offering, net of offering costs

 -

 5,408,575

 Net cash provided by financing activities

 8,979,529

 11,903,491

 Net change in cash

 1,615,442

 8,369,914

 Cash and cash equivalents – beginning of the period

 32,586

 Cash and cash equivalents – end of the period

 $
 10,017,942

 $

 Supplemental disclosure of non-cash financing activity:

 Issuance
 of common shares to settle convertible debt

 $
 -

 $
 1,140,700

 De-recognition
 of derivative liabilities

 $
 -

 $
 4,596,039

 The accompanying notes are an integral part
of these financial statements.

 F- 6

Notes to Financial Statements

 Note 1. Description of Business and Summary
of Significant Accounting Policies

 Cadrenal Therapeutics, Inc. (the "Company"
or "Cadrenal") was incorporated on January 25, 2022 in the State of Delaware and is headquartered in Ponte Vedra, Florida.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing specialized therapeutics for rare cardiovascular
conditions. The Company is developing its late-stage asset, tecarfarin, a new oral vitamin K antagonist (VKA) designed to be a better
and safer anticoagulant than warfarin, for individuals with implanted cardiac devices. Although warfarin is widely used off-label for
several rare cardiovascular conditions, extensive clinical and real-world data have shown it to have significant serious side effects.
With its innovation, Cadrenal aims to meet the unmet needs of this patient population by relieving them and their healthcare providers
of some of warfarin's greatest clinical challenges.

 Cadrenal is pursuing a product-in-a-pipeline approach
with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted left ventricular
assist devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation
(ESKD+AFib).

 Basis of Presentation

 The accompanying financial statements have been
prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") and applicable
rules and regulations of the U.S. Securities and Exchange Commission ("SEC") for the fair presentation of the Company's
financial statements for the periods presented. The Company's fiscal year-end is December 31.

 Liquidity

 The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities
and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability
and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since
its inception, the Company has incurred operating losses and negative cash flows from operations. For the year ended December 31, 2024,
the Company had a net loss of $ 10.7 million, which included $ 1.4 million of non-cash expenses. Cash used in operations totaled $ 7.4 million.
As of December 31, 2024, the Company had cash and cash equivalents of $ 10.0 million, net working capital of $ 7.4 million, and an accumulated
deficit of $ 25.7 million.

 During January through March 13, 2025, the Company sold 72,224 shares of
its common stock through its at-the-market (ATM) facility with H.C. Wainwright & Co. These sales were made at a weighted average price
of $ 20.29 per share, resulting in total gross proceeds of approximately $ 1,466,000 and net proceeds of approximately $ 1,419,000.

 The Company's cash and cash equivalents balance of approximately
$ 7.9 million as of March 13, 2025 is expected to be sufficient to fund its operations for at least the next twelve months from the
date of the filing of its Annual Report on Form 10-K, however, the Company will require additional funding to complete its planned Phase 3
clinical trial and submit its new drug application.

 Management intends to raise additional funds through
partnering and equity and debt financings. However, there can be no assurance that the Company will be able to complete partnering transactions
or financings on terms acceptable to the Company or at all. If the Company is unable to raise additional funding to meet its working capital
needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease its operations. The
financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 Emerging Growth Company Status

 As an "emerging growth company" ("EGC")
under the Jumpstart Our Business Startups Act ("JOBS Act"), the Company may elect to take advantage of certain forms of relief
from various reporting requirements that are applicable to public companies. The relief afforded under the JOBS Act includes an extended
transition period for the implementation of new or revised accounting standards. The Company has elected to take advantage of this extended
transition period and, as a result, the Company's financial statements may not be comparable to those of companies that implement
accounting standards as of the effective dates for public companies. The Company may take advantage of the relief afforded under the JOBS
Act up until the last day of the fiscal year following the fifth anniversary of an offering or such earlier time that it is no longer
an EGC.

 F- 7

 Use of Estimates

 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 as of the date of the financial statements and the reported amounts of expenses during the reporting
period. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value
of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. The Company evaluates
its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions
when facts and circumstances change. Actual results could differ from those estimates.

 Concentration of Credit and Other Risks
and Uncertainties

 Financial instruments, which potentially subject
the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents. Cash is maintained at high credit
quality financial institutions and, at times, balances may exceed federally insured limits. All interest-bearing and non-interest-bearing
cash balances are insured up to $ 250,000 at each financial institution. Any loss incurred or a lack of access to such funds could have
a significant adverse impact on the Company's financial condition, results of operations, and cash flows.

 The Company is subject to a number of risks common
for early-stage biopharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of its product
candidate, ability to obtain regulatory approval of its product candidate, the need for substantial additional financing to achieve its
goals, uncertainty of broad adoption of its approved products, if any, by physicians and patients, significant competition and untested
manufacturing capabilities.

 Segment Reporting

 Operating segments are defined as components of
an entity where separate financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to
allocate resources and assess performance. The Company's CODM is the Chief Executive Officer, who reviews financial information
on a company-wide basis for purposes of allocating resources and assessing financial performance. The Company manages its business activities
as a single entity and operates in one reportable segment.

 The CODM assesses performance of its one reportable segment and decides
how to allocate resources based on loss from operations and net loss. The CODM utilizes loss from operation and net loss to
evaluate the Company's business plan, which includes clinical development roadmaps and long-range financial models as key inputs
to decisions on resource allocation and its assessment of the performance of the business.

 Significant expenses within loss from operations, as well as within
net loss include research and development and general and administrative expenses, which are each separately presented on the Company's
statement of operations and comprehensive loss. The accounting policies used to measure the profit and loss of the segment are the
same as those described in the summary of significant accounting policies.

 The measure of segment assets is reported on the balance sheet as total
assets.

 Cash and Cash Equivalents

 The Company considers all highly liquid investments
purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash and cash equivalents
include cash and money market funds.

 Derivative Financial Instruments

 The Company evaluates all of its agreements to
determine whether such instruments are derivatives or contain features that qualify as embedded derivatives. Derivative financial liabilities
are initially recorded at fair value, with gains and losses arising from changes in the fair value recognized in other (income) expense
in the accompanying statements of operations and comprehensive loss for each reporting period while such instruments are outstanding.
Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement
of the derivative instrument could be required within 12 months of the balance sheet date.

 F- 8

 Stock-Based Compensation

 The Company measures its stock-based awards granted
to employees, consultants, and directors based on the estimated grant-date fair values of the awards and recognizes the compensation over
the requisite service period using the straight-line method. The Company uses the Black-Scholes option-pricing model to estimate the fair
value of its stock option awards. The Company accounts for forfeitures as they occur.

 The Black-Scholes model requires the use of highly
subjective and complex assumptions, which determine the fair value of stock-based payment awards, including the option's expected
term and the price volatility of the underlying stock. The Company estimates the fair value of options granted by using the Black-Scholes
model with the following assumptions:

 Expected Volatility—The Company
estimated volatility for option grants by evaluating the historical volatility of a peer group of companies for the period immediately
preceding the option grant for a term that is approximately equal to the options' expected term.

 Expected Term—The expected term
of the Company's options represents the period that the stock-based payment awards are expected to be outstanding. The expected
term was estimated using the simplified method for employee stock options since the Company does not have adequate historical exercise
data to estimate the expected term.

 Deferred Offering Costs

 The Company capitalizes certain legal, professional,
and other third-party costs that are directly associated with in-process equity financings until such financings are consummated, at which
time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred
offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss.

 Income Taxes

 Income taxes are accounted for under the asset
and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial
statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected
to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A
valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
Due to the Company's historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation
allowance.

 The Company recognizes uncertain income tax positions
at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax
position will not be recognized if it has less than a 50 % likelihood of being sustained. Changes in recognition or measurement are reflected
in the period in which judgment occurs. The Company's policy is to recognize interest and penalties related to the underpayment
of income taxes as a component of the provision for income taxes.

 Net Loss Per Common Share

 Basic net loss per common share is calculated
by dividing the net loss by the weighted-average number of shares of common stock and pre-funded warrants outstanding for the period,
without consideration for potential dilutive shares of common stock. Diluted net loss per common share is computed by dividing net loss
by the weighted average number of shares of common stock and common stock equivalents of potentially dilutive securities outstanding for
the period determined using the treasury stock or if-converted methods. Since the Company was in a loss position for all periods presented,
basic net loss per common share is the same as diluted net loss per common share since the effects of potentially dilutive securities
are anti-dilutive. Shares of common stock subject to repurchase are excluded from the weighted-average shares.

 F- 9

 Comprehensive Loss

 Comprehensive loss is defined as the change in
equity during a period from transactions and other events or circumstances from non-owner sources. Net loss and comprehensive loss were
the same for the periods presented in the accompanying financial statements.

 Research and Development Expenses

 Research and development costs are expensed as
incurred and consist of fees paid to other entities that conduct certain research and development activities on the Company's behalf.
Acquired intangible assets are expensed as research and development costs if, at the time of payment, the technology is under development;
is not approved by the United States Food and Drug Administration ("FDA") or other regulatory agencies for marketing; has
not reached technical feasibility; or otherwise has no foreseeable alternative future use. Non-refundable advance payments for goods or
services to be received in the future for use in research and development activities are capitalized and then expensed as the related
goods are delivered or the services are performed.

 On January 19, 2023, the Company issued 40,000 shares of
common stock to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement, dated August 18, 2022, between the Company
and HESP LLC. This payment was determined to be in process research and development with no alternative use. Accordingly, the Company
recorded the common stock payment of $ 3.0 million as research and development expense. This payment settled all obligations under
the Amendment to the Asset Purchase Agreement.

 Patents

 Patent costs are comprised primarily of external
legal fees, filing fees incurred to file patent applications, and periodic renewal fees to keep the patent in force and are expensed as
incurred as a component of general and administrative expenses.

 Reclassification of Prior Year Presentation

 Certain prior year amounts have been reclassified for consistency with
the current year's presentation. These reclassifications had no effect on the reported results of operations. An adjustment has been made
to the balance sheet as of December 31, 2023, to reclassify the Company's interest receivable from prepaid expenses and other current
assets.

 Note 2. Recent Accounting Pronouncements

 Recently Adopted Accounting Pronouncements

 In November 2023, the FASB issued Accounting Standards Update, or ASU,
2023-07, Segment Reporting (Topic280): Improvements to Reportable Segment Disclosures. The ASU expands public entities' segment
disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker,
or CODM, and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment
items, and interim disclosures of a reportable segment's profit or loss and assets. The ASU also allows, in addition to the measure
that is most consistent with GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing
segment performance and deciding how to allocate resources. All disclosure requirements under ASU 2023-07 are also required for public
entities with a single reportable segment. The adoption of this ASU had no material impact on the Company's financial statements.

 Accounting Pronouncements Not Yet Adopted

 In December 2023, the FASB issued ASU 2023-09,
Improvements to Income Tax Disclosures. The ASU requires greater disaggregation of information about a reporting entity's effective
tax rate reconciliation as well as information on income taxes paid. The ASU applies to all entities subject to income taxes and is intended
to help investors better understand an entity's exposure to potential changes in jurisdictional tax legislation and assess income
tax information that affects cash flow forecasts and capital allocation decisions. The ASU is effective for annual periods beginning after
December 15, 2024, with early adoption permitted. The ASU should be applied on a prospective basis although retrospective application
is permitted. The Company is currently evaluating the impact of this standard on its disclosures.

 In November 2024, the FASB issued ASI 2024-03
Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40). The ASU aims to
improve financial reporting by requiring that public business entities disclose additional information about specific expense categories
in the notes to financial statements at interim and annual reporting periods. In January 2025, the ASU was subsequently amended by ASU
2025-01 to clarify the effective date of which all public business entities are required to adopt the guidance in annual reporting periods
beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. Early adoption
of ASU 2024-03 is permitted. The Company is currently evaluating the impact of this guidance on its financial statements.

 F- 10

 Note 3. Fair Value Measurements

 Assets and liabilities recorded at fair value
on a recurring basis in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure
their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid
to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market
participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize
the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for
disclosure of fair value measurements as follows:

 Level 1 —

 Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.

 Level 2 —

 Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

 Level 3 —

 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 The Company classified its embedded derivative
liability as a Level 3 financial instrument and measured and reported its embedded derivatives at fair value. Concurrent with the closing
of the initial public offering in January 2023, the note holders converted the debt into common stock, accordingly, the derivative financial
liabilities were de-recognized and reclassified to stockholders' equity (deficit) on January 24, 2023.

 Financial assets and liabilities subject to fair
value measurements on a recurring basis and the level of inputs used in such measurements by major security type are presented in the
following table:

 December 31, 2024

 Level 1

 Level 2

 Level 3

 Fair Value

 Financial Assets:

 Money market funds

 $
 9,946,189

 $
 -

 $
 -

 $
 9,946,189

 Total financial liabilities

 $
 9,946,189

 $
 -

 $
 -

 9,946,189

 December 31, 2023

 Level 1

 Level 2

 Level 3

 Fair Value

 Financial Assets:

 Money market funds

 $
 8,287,843

 $
 -

 $
 -

 $
 8,287,843

 Total financial liabilities

 $
 8,287,843

 $
 -

 $
 -

 $
 8,287,843

 The following table summarizes the changes
in the fair value of the derivative liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level
3)

 Derivative
 Liabilities

 Balance at December 31, 2022

 $
 4,379,944

 Change in fair value

 216,095

 De-recognition of derivative liabilities

 ( 4,596,039
)

 Balance at December 31, 2023

 $
 -

 F- 11

 The carrying amounts of cash and cash equivalents,
prepaid expenses, deferred offering costs, accounts payable, and accrued liabilities approximate their fair values due to their short-term
nature. There were no transfers of liabilities among the fair value measurement categories during any of the periods presented.

 Note 4. Accrued Liabilities

 Accrued liabilities consist of the following:

 December 31, 2024

 December 31, 2023

 Accrued consulting fees

 $
 162,606

 $
 4,000

 Accrued compensation

 966,575

 596,131

 Other

 52,309

 38,075

 Total accrued liabilities

 $
 1,181,490

 $
 638,206

 Note 5. Leases, Commitments, and Contingencies

 Leases

 In accordance with ASC 842, Leases, the Company
determines if an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right
to control the use of an identified asset for a period of time in exchange for consideration.

 At lease inception, the Company determines whether
an arrangement is an operating or capital lease. For operating leases, the Company recognizes rent expense, inclusive of rent escalation,
on a straight-line basis over the lease term.

 The Company classifies leases at the lease commencement
date as operating or finance leases and records a right-of-use asset and a lease liability on the balance sheet for all leases with an
initial lease term of greater than 12 months. Leases with an initial term of 12 months or less are not recorded in the balance sheet pursuant
to the practical expedient available under ASC 842, but payments are recognized as expenses on a straight-line basis over the lease term.

 Finance and operating right-of-use assets and
lease liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using
the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental
borrowing rate based upon the available information at the lease commencement date. Operating lease assets are further adjusted for prepaid
or accrued lease payments. Operating lease expense is recognized on a straight-line basis over the lease term.

 F- 12

 The Company's operating lease right-of-use
assets and lease liabilities as of December 31, 2024 and 2023 are as follows:

 2024

 2023

 Assets

 Right of use assets

 $
 -

 $
 20,998

 Liabilities

 Current

 Operating lease liabilities

 $
 -

 $
 21,350

 Total operating lease liabilities

 $
 -

 $
 21,350

 In October 2024, the Company amended its
lease for office space to extend the lease term for one additional year. The lease agreement (as amended) has a term that extends
through October 31, 2025 with no option to renew. Operating lease expenses were $ 26,559 and $ 26,555 for the years ended December 31,
2024 and 2023, respectively. Cash paid for amounts included in the measurement of operating lease liabilities included in operating
cash flows was $ 22,319 and $ 26,003 for the years ended December 31, 2024 and 2023, respectively.

 Future annual lease payments under non-cancellable
operating leases as of December 31, 2024 were as follows:

 2025

 $
 22,742

 Total lease payments

 $
 22,742

 Contingencies

 In the normal course of business, the Company
enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications.
The Company's exposure under these agreements is unknown, because it involves claims that may be made against the Company in the
future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will
be made and such expenditures can be reasonably estimated.

 Indemnification

 In accordance with the Company's certificate
of incorporation and bylaws, the Company indemnifies its officers and directors for certain events or occurrences, subject to certain
limits, while they are serving in such capacity. In addition, the Company has entered into indemnification agreements with its officers
and directors. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable
it to recover a portion of any amounts paid for future claims.

 Note 6. Stockholders' Equity and
Warrants

 Reverse Stock Split

 On July 29, 2024, the Company's stockholders
approved amendments to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its shares of common stock,
and its Board of Directors subsequently approved a final reverse stock split ratio of 1-for-15. The reverse stock split became effective
on August 20, 2024. On the effective date, every 15 shares of issued and outstanding common stock were combined and converted into one
issued and outstanding share of common stock. The number of authorized shares of common stock was not reduced and the par value per share
of common stock remains unchanged. Fractional shares were canceled, and stockholders received cash in lieu thereof. A proportionate adjustment
was also made to the maximum number of shares of common stock issuable under the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive
Plan. As a result, the number of common shares, stock options, warrants, net loss per share, and exercise prices disclosed throughout
these notes to the financial statements, as well as the Annual Report on Form 10-K to which these financial statements and notes thereto
are attached, have been retrospectively adjusted to reflect the reverse stock split.

 F- 13

 Common Stock

 The Company is authorized to issue a total of 75,000,000 shares
of common stock with a par value of $ 0.001 per share and 7,500,000 shares of preferred stock, par value $ 0.001 per
share.

 Holders of common stock are entitled to one vote
for each share of common stock held of record for the election of the Company's directors and all other matters requiring stockholder
action. Holders of common stock will be entitled to receive such dividends, if any, as may be declared from time to time by the Company's
Board in its discretion out of funds legally available therefor.

 On January 24, 2023, the Company consummated its
IPO and issued 93,333 shares of its common stock at a public offering price of $ 75.00 per share, generating gross proceeds of $ 7.0 million
and net proceeds of $ 5.4 million.

 In connection with the IPO, on January 19, 2023,
the Company entered into an underwriting agreement (the "Underwriting Agreement") with Boustead Securities, LLC, as representative
of the underwriters (the "Representative"). Pursuant to the Underwriting Agreement, the Company issued to the underwriters
a five-year warrant (the "Representative's Warrant") to purchase an aggregate of 5,600 shares of the Company's common
stock, which was equal to six percent ( 6 %) of the shares of common stock sold in the IPO. The Representative's Warrant has an exercise
price of $ 90.00, which was equal to 120 % of the public offering price of the common stock in the IPO.

 On July 12, 2023, the Company entered into a securities
purchase agreement with an institutional investor (the "Investor Selling Stockholder") pursuant to which the Company sold
to the Investor Selling Stockholder in a private placement (the "Private Placement") (i) an aggregate of 86,667 shares of
common stock (the "Shares"), (ii) in lieu of additional Shares, pre-funded warrants to purchase up to an aggregate of 199,047
shares of common stock (the "Pre-Funded Warrants"), and (iii) accompanying common warrants to purchase up to an aggregate
of 285,715 shares of common stock (the "Common Warrants"). The combined purchase price of each Share and accompanying Common
Warrants was $ 26.25. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $ 26.25.

 The Private Placement closed on July 14, 2023.
The Company received aggregate gross proceeds from the Private Placement of approximately $ 7.5 million before deducting the placement
agent commissions and offering expenses payable by the Company. H.C. Wainwright & Co., LLC ("H.C.W.") acted as the placement
agent in the Private Placement, and as part of its compensation, the Company issued to designees of H.C.W. Placement Agent Warrants to
purchase up to 18,571 shares of common stock at an exercise price of $ 32.81.

 Each Pre-Funded Warrant had an exercise price
equal to $ 0.0015 per share. The Pre-Funded Warrants were exercisable at any time after their original issuance and would not expire until
exercised in full. Each Common Warrant has an exercise price equal to $ 26.25 per share. The Common Warrants are exercisable at any time
after their original issuance and will expire on January 16, 2029. The exercise price and number of shares of common stock issuable upon
exercise of the Common Warrant and Pre-Funded Warrant are subject to appropriate adjustment in the event of stock dividends, stock splits,
reorganizations or similar events.

 During the year ended December 31, 2024, the Company
received notice of the exercise of all of the 199,047 Pre-Funded Warrants. As a result of the respective Pre-Funded Warrant
exercises, the Company issued 199,047 shares of common stock. As of December 31, 2024, there are no Pre-Funded Warrants outstanding.

 The Common Warrants issued in the Private Placement
provide that a holder of Common Warrants, as applicable, will not have the right to exercise any portion of its Common Warrants if such
holder, together with its affiliates, and any other party whose holdings would be aggregated with those of the holder for purposes of
Section 13(d) or Section 16 of the Exchange Act would beneficially own in excess of 4.99 % of the number of shares of common stock outstanding
immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that the
holder may increase or decrease the Beneficial Ownership Limitation by giving notice to the Company, with any such increase not taking
effect until the sixty-first day after such notice is delivered to the Company but not to any percentage in excess of 9.99 %. The Common
Warrants may be exercised on a cashless basis if a registration statement registering the shares of common stock underlying the Common
Warrants is not effective at the time of exercise.

 F- 14

 ATM Facility

 During the year ended December 31, 2024, the Company
sold 391,243 shares of its common stock through its at-the-market (ATM) facility with H.C. Wainwright & Co. These sales
were made at a weighted average price of $ 13.15 per share, resulting in total gross proceeds of $ 5.1 million and net proceeds
of $ 4.8 million.

 Warrant Inducement

 On November 1, 2024, the Company entered into
a warrant inducement letter agreement (the "Inducement Agreement") with a holder of the Company's warrants to purchase
shares of the Company's Common Stock, issued in a private placement offering that closed on July 14, 2023 (the "Existing Warrants").
Pursuant to the Inducement Agreement, the holder of the Existing Warrants agreed to exercise for cash the Existing Warrants to purchase
up to an aggregate of 285,715 registered shares of common stock, at the adjusted exercise price of $ 16.50 per share (reduced from the
initial exercise price of $ 26.25 per share).

 In consideration of the holder's agreement to
exercise the Existing Warrants at the reduced exercise price per share in accordance with the Inducement Agreement, the Company issued
to the holder new unregistered Series A-1 Common Stock warrants (the "Series A-1 Warrants") to purchase 285,715 shares of
common stock and new unregistered Series A-2 Common Stock warrants (the "Series A-2 Warrants") to purchase an aggregate of
 285,715 shares of common stock, at an exercise price of $ 16.50 per share. The Series A-1 Warrants were immediately exercisable for a term
of five years from the date of issuance, and the Series A-2 Warrants were immediately exercisable for a term of 18 months from the date
that the Company's registration statement on Form S-3, has been declared effective (November 22, 2024) by the Securities and Exchange
Commission. The New Warrants contain customary provisions for anti-dilution adjustments to the exercise price, including stock splits,
stock dividends, rights offerings, and pro rata distributions.

 On November 4, 2024, the transactions contemplated by the Inducement Agreement
closed, and the Company received aggregate gross proceeds of approximately $ 4.7 million for the exercise of the Existing Warrants, before
deducting placement agent fees and other expenses totaling $ 0.5 million.

 H.C.W. acted as the placement agent in the Inducement
Agreement, and as part of its compensation, the Company issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571
shares of common stock at an exercise price of $ 20.625. The Placement Agent Warrants expire five years after issuance and contain customary
provisions for anti-dilution adjustments to the exercise price, including for stock splits, stock dividends, rights offerings, and pro
rata distributions.

 The Series A-1 Warrants, Series A-2 Warrants,
and Placement Agent Warrants were classified as equity, and the offering costs were recorded as debit to additional paid-in capital.

 All of the Company's outstanding warrants provide that the holder
thereof has the right to participate in distributions or dividends paid on the Company's shares of common stock on an as-converted
basis.

 F- 15

 Warrant Summary

 The following table summarizes the total warrants
outstanding at December 31, 2024:

 rice

 as of

 as of

 Per

 Expiration

 New

 Issue Date

 Share

 Date

 2023

 Issuance

 Exercised

 2024

 Placement agent warrants

 July - Sept 2022

 $
 45.00

 July - Sept 2027

 -

 -

 Placement agent warrants

 Nov 2022

 $
 15.00

 Nov 2027

 1,000

 -

 -

 1,000

 Representative warrants

 Jan 2023

 $
 90.00

 Jan 2028

 5,600

 -

 -

 5,600

 Pre-funded investor warrants

 July 2023

 $
 0.0015

 Once exercised

 199,047

 -

 ( 199,047
)

 -

 Common warrants

 July 2023

 $
 16.50

 Jan 2029

 -

 ( 285,715
)

 -

 Placement agent warrants

 July 2023

 $
 32.81

 Jan 2029

 18,572

 -

 -

 18,572

 Series A-1 warrants

 Nov 2024

 $
 16.50

 Nov 2029

 -

 -

 Series A-2 warrants

 Nov 2024

 $
 16.50

 May 2026

 -

 -

 Placement agent warrants

 Nov 2024

 $
 20.625

 Nov 2029

 -

 18,571

 -

 18,571

 510,701

 590,001

 ( 484,762
)

 615,940

 Issuance of Restricted Common Stock

 In October 2024, the Company engaged consultants to perform certain
public and investor relations services in partial consideration of 50,000 shares of restricted common stock. The Company issued 25,000
shares of fully vested, nonrefundable restricted common stock on October 9, 2024 and the remaining 25,000 shares of restricted common
stock were issued on January 8, 2025.

 Note 7. Equity-Based Compensation

 The Company adopted the Cadrenal Therapeutics,
Inc. 2022 Equity Incentive Plan (the "Initial Plan"), on July 11, 2022, which was later amended and restated on October 16,
2022, for purposes of clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment
and restatement of the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive
Plan (the "Successor Plan") for the issuance and approval of awards after consummation of the IPO. On October 16, 2022,
the Board adopted and the Company's stockholders approved the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the
"2022 Plan"), which is a successor to and continuation of the Initial Plan and became effective on January 19, 2023. Upon
the effectiveness of the 2022 Plan, it replaced the Initial Plan, except with respect to awards outstanding under the Initial Plan, and
no further awards will be available for grant under the Initial Plan.

 Subject to certain adjustments, the maximum number
of shares of common stock that could have been issued under the Initial Plan and 2022 Plan was initially 133,333 shares. The maximum number
of shares of common stock that may be issued under the 2022 Plan will automatically increase on January 1 of each calendar year for
a period of ten years commencing on January 1, 2024 and ending on (and including) January 1, 2033, to a number of shares
of common stock equal to 20 % of the total number of shares of common stock outstanding on December 31 of the preceding calendar year;
provided, however that the board of directors, or the compensation committee, may act prior to January 1 of a given calendar year
to provide that the increase for such year will be a lesser number of shares of common stock. On January 1, 2024, the maximum number of
shares of common stock that may be issued under the 2022 Plan increased to 173,636. On July 29, 2024, the Company held its 2024 Annual
Meeting of Stockholders (the "2024 Annual Meeting"). At the 2024 Annual Meeting, the Company's stockholders approved
an amendment to the 2022 Plan to increase the number of shares of the Company's common stock that will be available for awards under
the 2022 Plan by 133,333 shares to 306,969 shares and to amend the "evergreen provision" such that the number of reserved
shares of common stock available for issuance each year will be 20 % of: (i) the shares of common stock outstanding at December 31; plus
(ii) the shares of common stock issuable upon exercise of warrants and pre-funded warrants outstanding at December 31. As of December
31, 2024, 141,303 remained available for future issuance. All available shares may be utilized toward the grant of any type of award under
the 2022 Plan.

 Weighted average assumptions used in the Black-Scholes
model are set forth below:

 2024

2023

 Risk-free interest rate

 4.09
- 4.83
 %

 4.51
 %

 Dividend yield

 -

 -

 Expected term (years)

 5.27 - 5.31

 5.33

 Volatility

 76.4 - 77.7
 %

 70.7
 %

 F- 16

 Activity under the Plans for the period from December 31,
2023 to December 31, 2024 is set forth below:

 Weighted-

 Weighted-

 Average

 Average

 Remaining

 Aggregate

 Number

 Price

 Contractual

 Intrinsic

 Per Share

 Life (Years)

 Value

 Outstanding at December 31, 2023

 78,333

 $
 12.92

 8.64

 $
 105,000

 Granted

 78,001

 13.48

 9.07

 78,420

 Exercised

 -

 -

 -

 -

 Canceled/forfeited/expired

 -

 -

 -

 -

 Outstanding at December 31, 2024

 $
 13.20

 8.35

 $
 420,720

 Options vested and exercisable at December 31, 2024

 80,792

 $
 12.80

 7.95

 $
 29,315

 Options vested and expected to vest as of December 31, 2024

 $
 13.20

 8.35

 $
 420,720

 The weighted average grant date fair value of
options granted during the year ended December 31, 2024 was $ 12.67. At December 31, 2024, the Company had $ 0.6 million of unrecognized
stock-based compensation expense related to stock options which will be recognized over the weighted average remaining requisite service
period of 1.4 years. The Company settles employee stock option exercises with newly issued shares of common stock.

 Total stock-based compensation expense and the
allocation of stock-based compensation for the periods presented below were as follows:

 Years Ended

 2024

 2023

 General and administrative

 $
 1,030,657

 $
 340,499

 Research and development

 388,382

 369,882

 Total stock-based compensation

 $
 1,419,039

 $
 710,381

 Note 8. Net Loss Per Share

 The following table sets forth the computation
of the basic and diluted net loss per common share:

 Years Ended

 2024

 2023

 Numerator:

 Net loss

 $
)

 $
)

 Denominator:

 Weighted average common shares outstanding

 1,219,550

 899,465

 Net loss per common share, basic and diluted

 $
 ( 8.73
)

 $
 ( 9.29
)

 Since the Company was in a loss position for the
periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive securities
would have been anti-dilutive. For the periods presented, there were no potential dilutive securities other than stock options and warrants.

 F- 17

 The following common stock equivalents were excluded
from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them
would have had an anti-dilutive effect:

 As of December 31,

 2024

 2023

 Anti-dilutive common stock equivalents:

 Stock options to purchase common stock

 78,333

 Warrants to purchase common stock

 615,940

 510,700

 Total anti-dilutive common stock equivalents

 772,274

 589,033

 Note 9. Income Taxes

 The Company's loss before provision (benefit)
for income taxes for the year ended December 31, 2024 and 2023 was generated in the following jurisdictions:

 2024

 2023

 Domestic

 $
 10,651,368

 $
)

 Foreign

 -

 -

 Loss before income taxes

 $
 10,651,368

 $
)

 The Company's provision is $ 0, which is
primarily driven by the federal and state statutory income tax rates on current-year losses, offset by the Company's full valuation
allowance.

 The components of income tax expense (benefit)
were as follows for the years ended December 31, 2024 and 2023:

2024

2023

 Current

 Federal

 $
 -

 $
 -

 State

 -

 -

 Foreign

 -

 -

 Total current provision

 -

 -

 Deferred:

 Federal

 -

 -

 State

 -

 -

 Foreign

 -

 -

 Total deferred provision

 -

 -

 Provision for income taxes

 $
 -

 $
 -

 F- 18

 A reconciliation of income tax expense (benefit)
to the amount computed by applying the statutory federal income tax rate to the loss from operations is summarized for the years ended
December 31, 2024 and 2023, as follows:

 2024

 2023

 Tax benefit at statutory tax rate

 $
 ( 2,236,787
)

 $
 ( 1,754,988
)

 State benefit, net of federal benefit

 ( 301,209
)

 ( 136,314
)

 Permanent differences

 5,602

 27,006

 Equity-based compensation

 89,753

 3,150

 Deferred rate change

 ( 51,462
)

 17,642

 Derivatives

 -

 141,457

 Other

 ( 68,827
)

 Increase in valuation allowance

 2,562,930

 1,702,000

 $
 -

 $
 -

 Deferred income taxes reflect the net tax effects
of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for
income tax purposes. Significant components of the Company's deferred tax assets and liabilities at December 31, 2024 and 2023 are
shown below. The Company has established a full valuation allowance against net deferred tax assets due to the uncertainty that such assets
will be realized. The Company periodically evaluates the recoverability of its deferred tax assets. At such time as it is determined that
it is more likely than not that the deferred tax asset will be realized, the valuation allowance will be reduced. The increase in the
valuation allowances of approximately $ 2,563,000 for the year ended December 31, 2024 was primarily due to an increase in the Company's
net operating losses and capitalized research costs occurring during the current year.

 The components of deferred tax assets and liabilities
consisted of the following at December 31, 2024 and 2023:

 2024

 2023

 Deferred tax assets:

 Net operating loss carryforwards

 $
 2,748,000

 $
 1,099,000

 Equity-based compensation

 286,000

 138,000

 Capitalized research costs

 1,475,000

 807,000

 Lease liabilities

 -

 5,000

 Accruals and other temporary differences

 235,000

 137,000

 Total deferred tax assets

 4,744,000

 2,186,000

 Convertible debt

 -

 -

 Right of use assets

 -

 ( 5,000
)

 Valuation allowance for deferred tax assets

 ( 4,744,000
)

 ( 2,181,000
)

 Net deferred tax asset

 $
 -

 $
 -

 F- 19

 As of December 31, 2024, the Company has net operating
loss carryforwards of approximately $ 11.3 million and $ 8.7 million available to reduce future taxable income, if any, for federal and
state income tax purposes, respectively. As of December 31, 2023, the Company has net operating loss carryforwards of approximately $ 4.7
million and $ 2.7 million available to reduce future taxable income, if any, for federal and state income tax purposes, respectively. The
Company's US federal and state net operating loss carryovers of $ 11.3 million and $ 4.7 million as of December 31, 2024 and 2023,
respectively, can be carried forward indefinitely, but the deduction related to these net operating losses is limited to 80 % of taxable
income when utilized in future years.

 The utilization of net operating loss carryforwards
and tax credit carryovers could be subject to annual limitations under Section 382 and 383 of the Internal Revenue Code of 1986,
and similar state tax provisions, due to ownership change limitations that may have occurred previously or that could occur in the future.
These ownership changes limit the amount of net operating loss carryforwards and other deferred tax assets that can be utilized to offset
future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382 and 383, results from transactions
increasing ownership of certain stockholders or public groups in the stock of the corporation by more than 50 percentage points over a
three-year period. The Company has not conducted an analysis of an ownership change under section 382. To the extent that a study is completed
and an ownership change is deemed to occur, the Company's net operating losses and tax credits could be limited.

 The Company applies the two-step approach to recognizing
and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of
available evidence indicates it is more likely than not that the position will be sustained upon audit, including resolution of related
appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount, which is more than 50 % likely
of being realized upon ultimate settlement. Income tax positions must meet a more likely than not recognition threshold to be recognized
under ASC 740 upon initial measurement and in subsequent periods. ASC 740-10 also provides guidance on measurement, derecognition,
classification, interest and penalties, accounting in interim periods, disclosure and transition.

 At December 31, 2024, the Company did not have
any significant uncertain tax positions. The Company will recognize interest and penalties related to uncertain tax positions in income
tax expense. As of December 31, 2024, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts
have been recognized in the Company's statement of operations and comprehensive loss. The Company does not anticipate a material
change to unrecognized tax benefits in the next twelve months.

 All of the Company's tax years will
remain open for examination by the federal and state taxing authorities to the extent that the Company's tax attributes are utilized
in future years to offset income or income taxes.

 Note 13. Subsequent Events

 The Company has evaluated events that occurred
through March 13, 2025, the date that the financial statements were issued, and determined that there have been no events that have occurred
that would require adjustments to its disclosures in the financial statements except for the transactions described below.

 From January 1, 2025 through March 13, 2025, the
Company sold 72,224 shares of its common stock through its at-the-market (ATM) facility with H.C.W. These sales were made at a weighted
average price of $ 20.29 per share, resulting in total gross proceeds of approximately $ 1,466,000 and net proceeds of approximately $ 1,419,000.

 F- 20

 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, 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 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, or persons performing
similar functions, as appropriate to allow timely decisions regarding required disclosure. We have adopted and maintain disclosure controls
and procedures (as defined Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to provide reasonable assurance that
information required to be disclosed in the reports filed under the Exchange Act, such as this Annual Report, is collected, recorded,
processed, summarized, and reported within the time periods specified in the rules of the SEC. Our disclosure controls and procedures
are also designed to ensure that such information is accumulated and communicated to management 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 the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief
Executive Officer and Chief Financial Officer concluded that, as of such a date, our disclosure controls and procedures were effective
at the reasonable assurance level.

 Management's Report on Internal Control over Financial Reporting

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

 1.
 pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets
of our company,

 2.
 provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S.
GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors, and

 3.
 provide
reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of our assets that
could have a material effect on the financial statements.

 Because of its inherent limitations, internal
control over financial reporting may not prevent or detect errors or misstatements in our financial statements. Also, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree or compliance with the policies or procedures may deteriorate. Management assessed the effectiveness of our internal
control over financial reporting as of December 31, 2024. In making these assessments, management used the criteria set forth by the Committee
of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013). Based on our assessments
and those criteria, management determined that our internal controls over financial reporting were effective as of December 31, 2024.

 This Annual Report does not include an attestation
report of internal controls from our independent registered public accounting firm due to our status as an emerging growth company under
the JOBS Act.

 Changes in Internal Control over Financial Reporting

 During the quarter ended December 31, 2024, there
were no changes in our internal control over financial reporting (as defined in Rules 13a 15(f) and 15d 15(f) of the Exchange Act) that
occurred that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 Report of Independent Registered Public Accounting Firm

 This Annual Report does not include an attestation
report by WithumSmith+Brown, PC, our independent registered public accounting firm, regarding internal control over financial reporting.
As a smaller reporting company, our internal control over financial reporting was not subject to audit by our independent registered public
accounting firm pursuant to rules of the SEC that permit us to provide only management's report.

 Item 9B. Other Information.

 During the three months ended December 31, 2024,
 no director or officer of the Company adopted or terminated a "Rule 10b5-1 trading arrangement" or
"nonRule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.

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

 Not Applicable.

 Item 10. Directors, Executive Officers and
Corporate Governance.

 Information About our Executive Officers and Directors

 The following table sets forth information concerning
our directors and executive officers, including their ages, as of March 13, 2025. There are no family relationships among any of our directors
or executive officers.

 Name

 Age

 Position

 Executive Officers and Directors

 Chairman and Chief Executive Officer

 Chief Financial Officer

 James Ferguson

 Chief Medical Officer

 Chief Operating Officer

 Non-Employee Directors

 Glynn Wilson

 Steven Zelenkofske

 Quang X. Pham, Chairman and Chief Executive
Officer

 Quang X. Pham has served as our Chief Executive
Officer since he formed the Company. Since October 2023, he has served as a director of Cognition Ads, a privately-held cloud ad tech
company. He previously served as Chief Executive Officer, Chairman of the Board of Directors and co-founder of Espero, the previous sponsor
of the tecarfarin IND, since its formation in March 2015 until July 2020, at which time a petition for assignment for the benefit of creditors
was filed in the Delaware Chancery Court, seeking an assignment of Espero's assets. He then served as a consultant to HESP LLC,
the assignee of Espero, from July 2020 until December 2021. From February 2012 to August 2015, Mr. Pham was a partner with D+R LATHIAN,
LLC, a life sciences multichannel marketing agency. Prior to joining D+R LATHIAN, he founded and served as Chairman and Chief Executive
Officer of Lathian Systems, Inc., a digital and database marketing company serving the pharmaceutical industry from 2000 until 2003 and
from 2008 until 2012 when the company was acquired by D&R Communications, LLC in February 2012. He has a Bachelor of Arts in Economics
from UCLA, and served as a U.S. Marine Corps Officer. We believe Mr. Pham is qualified to serve on our Board of Directors because of his
significant business, mergers and acquisitions, and fundraising experience, numerous interactions with the FDA, continuous eight-year
history with tecarfarin development, and his extensive knowledge of the pharmaceutical industry and our competitors.

 Matthew Szot, Chief Financial Officer

 Matthew Szot has served as our Chief Financial
Officer since May 2022. From March 2010 to November 2021, Mr. Szot served as Executive Vice President and Chief Financial Officer of S&W
Seed Company, a Nasdaq-listed agricultural seed biotechnology company. Since September 2020, Mr. Szot has served on the Board of Directors
and as Chairman of the Audit and Compensation Committees of NAYA Bioscience, Inc., a Nasdaq-listed commercial-stage fertility company.
He also serves on the Board of Directors and serves as Chairman of the Audit Committee of SenesTech, Inc., a Nasdaq-listed life science
company with next-generation technologies for managing animal pest populations through fertility control. From June 2018 to August 2019,
Mr. Szot served on the Board of Directors and as Chairman of the Audit Committee of Eastside Distilling, a Nasdaq-listed craft spirits
company. From 2007 until 2011, Mr. Szot served as the Chief Financial Officer for Cardiff Partners, LLC, a strategic consulting company
that provided executive financial services to various publicly traded and privately held companies. From 2003 to 2006, he served as Chief
Financial Officer of Rip Curl, Inc., a market leader in wetsuit and action sports apparel products. From 1996 to 2003, Mr. Szot was a
Certified Public Accountant with KPMG in the San Diego and Chicago offices and served as an Audit Manager for various publicly traded
companies. Mr. Szot graduated from the University of Illinois, Champaign-Urbana with a BS in Agricultural Economics/Accountancy. He is
a Certified Public Accountant in the State of California. Mr. Szot brings a wealth of knowledge in mergers and acquisitions, corporate
strategy, equity and debt financings, corporate governance, SEC reporting and compliance, and developing and implementing financial and
operational workflows and process improvements. He also has extensive experience in international operations, joint ventures, and technology
license agreements.

 James J. Ferguson III, Chief Medical Officer

 James Ferguson has served as our Chief Medical
Officer since February 2025. Dr. Ferguson is a well-recognized, industry-leading academic and clinical expert with over 25 years of experience
in the cardiovascular space. Prior to joining Cadrenal, he served as the Chief Medical Officer of Matinas BioPharma Holdings, Inc. from
February 2019 until October 2024 and as the Cardiovascular and Bone Therapeutic Area Head for U.S. Medical Affairs, at Amgen, multinational
biopharmaceutical company, from 2016 to 2019. Prior to Amgen Dr. Ferguson held a number of senior positions at AstraZeneca, a multinational
pharmaceutical and biopharmaceutical company, including Vice President of U.S. Cardiovascular Medical and Scientific External Relations,
Therapeutic Area Vice President of Cardiovascular Global Medical Affairs, U.S. Development Brand Leader for BRILINTA,
and Senior Director, Clinical Research. Before joining AstraZeneca, he was Vice President of Surgical and Critical Care for The Medicines
Company. In addition, Dr. Ferguson had more than 20 years of academic experience as the Associate Director of Clinical Cardiology Research
at the Texas Heart Institute, Co-Director of the Cardiology Fellowship Training Program at St. Luke's Episcopal Hospital in Houston,
where he was an Associate Professor of Medicine at Baylor College of Medicine, and a Clinical Assistant Professor at the University of
Texas Health Science Center at Houston. Dr. Ferguson has served on the Editorial Board of numerous peer-reviewed journals and has over
400 publications and book chapters. Dr. Ferguson received his B.A. (cum Laude) in Biology from Harvard University, his M.D. from the University
of Pennsylvania School of Medicine and completed his post-graduate training at the University of Michigan Medical Center, Ann Arbor, Michigan
and Beth Israel Hospital, Boston, Massachusetts.

 Jeffrey Cole, Chief Operating Officer

 Jeffrey Cole has served as our Chief Operating
Officer since February 2024 and has served as a consultant to the Company since November 2023. Mr. Cole brings over 25 years of experience
in global pharmaceutical manufacturing and commercial operations, finance, and corporate development. Since August 2010, Mr. Cole has
served as Principal of J. Scott Capital, LLC, a firm that provides executive and capital resources to emerging growth life science organizations.
From March 2015 to July 2020, he served as President, Chief Financial Officer and co-founder of Espero, where he also served as a director
from April 2016 until August 2018. From August 2010 to February 2015, he served as President and co-founder of MarcasUSA, LLC, a marketer
and distributor of over-the-counter pharmaceuticals. From May 2008 to August 2010, Mr. Cole was Chief Financial Officer of Legacy Pharmaceuticals
International GmbH, a global contract manufacturing organization, and founding President of its generic pharmaceuticals subsidiary Solco
Healthcare U.S., Inc. From February 2002 to May 2008, Mr. Cole held various executive positions at Valeant Pharmaceuticals International,
Inc. (now Bausch Health Companies), a NYSE-listed company, including General Manager, Vice President of Corporate Development, and Chief
Financial Officer for North America. Prior to the pharmaceutical industry, Mr. Cole worked in the technology industry and also served
as Principal in the Financial Management Consulting practice at PricewaterhouseCoopers. Mr. Cole holds an MBA with honors from the University
of Michigan and a BS in accounting from the University of Southern California.

 Mr. Lisicki has served on our Board of Directors since July 2023.
He currently serves as Chief Executive Officer and Director of Zura Bio, a clinical stage auto-immune company. Since October of 2023,
Mr. Lisicki has served as an Independent Director of Adiso Therapeutics, a privately held clinical-stage auto-immune company. From October
2022 until March 2023, he served as the Chief Executive Officer and board member of InCarda Therapeutics, Inc., a privately held clinical-stage
biopharmaceutical company focused on cardiovascular diseases. Previously, he served as Executive Vice President and Chief Commercial
Officer of Arena Pharmaceuticals ("Arena") from November 2018 until March 2022, when Arena was acquired by Pfizer, Inc. Prior
to joining Arena, Mr. Lisicki served as General Manager, Vice President Cardio-Metabolic and Inflammation at Regeneron Pharmaceuticals,
Inc. from June 2018 to November 2018, leading the Company's U.S.-based cardiovascular and inflammation business, and Senior Vice
President of Sales and Marketing and Chief Customer Officer at Daiichi Sankyo, Inc. from August 2014 until February 2018, with responsibility
for the company's U.S.-based cardiovascular and oncology therapeutics. Mr. Lisicki also held several management positions at Amgen
Inc. between 2005 and 2014, including Vice President and General Manager, responsible for a 700+ person sales force in the U.S. His U.S.
leadership experiences included such market shaping products Enbrel and Prolia. During his tenure he also covered several ex-U.S. regions,
and worked as an International Franchise Lead running the development and international strategies and business plans across Amgen's
portfolio including Nephrology, Cardiology, Bone and Oncology. Mr. Lisicki held various sales and marketing positions at Johnson &
Johnson Corporation. Mr. Lisicki brings over 25 years of experience in biopharmaceutical management, sales and marketing to the Company.
Mr. Lisicki holds a Bachelor of Science degree in Finance and Business Administration from the State University of New York at Albany.
Mr. Lisicki is qualified to serve on our Board of Directors due to his public company experience and his biopharmaceutical management,
sales, and marketing experience.

 John R. Murphy has served on our Board of Directors since January 2023.
Since 2003, John R. Murphy has served on the Board of Directors of O'Reilly Automotive, Inc., where he served as Chairman of the
Audit Committee from 2003 until 2019. Currently, he serves on the Audit Committee and Human Capital and Compensation Committee (Chair).
Mr. Murphy also served on the Board of Directors of Summit Materials, Inc. from 2012 to 2024, where he was the Chair of the Audit Committee.
Previously he served as a Director, Audit Committee Chairman, and Member of the Nominating and Governance Committee of Apria, Inc. ("Apria")
from August 2019 until April 2022. He also served on the Board of Directors of Alight Solutions LLC and was the Audit Committee Chairman
from February 2020 until May 2022 and DJO Global, Inc. from 2012 until 2019. Mr. Murphy also previously served on the Board of Directors
of Graham Packaging, Inc. and Accuride Corporation, Inc. He previously served as Interim Chief Financial Officer of Summit Materials,
Inc. in 2013, Senior Vice President and Chief Financial Officer of Smurfit-Stone Container Corporation from 2009 to 2010, and Chief Financial
Officer, then President and Chief Operating Officer, then President and Chief Executive Officer with Accuride Corporation, Inc. from 1998
to 2008. Mr. Murphy holds a Bachelor of Science in Accounting from Pennsylvania State University and a Master of Business Administration
from the University of Colorado, and is a Certified Public Accountant. We believe Mr. Murphy is qualified to serve on our Board of Directors
due to his substantial experience guiding public company boards and knowledge and experience as chief financial officer.

 Glynn Wilson, Ph. D.

 Dr. Glynn Wilson has served on our Board of Directors since January
2023. He is currently Chief Executive Officer and Director of Caring Brands, Inc. He was on the Board of Directors of Jupiter Wellness,
Inc. ("Jupiter") since November 2018, serving as Chairman since October 2019. Dr. Wilson also served as Jupiter's Chief
Scientific Officer since April 2021 and served as its Head of Research and Development from October 2019 to July 2021. Dr. Wilson previously
served as a Director of TapImmune, Inc. from February 2005 until October 2018 and as Chief Executive Officer from July 2009 through September
2017. Dr. Wilson also served as President of Auriga Laboratories, Inc. from June 1, 2005 through March 13, 2006, and as Chief Scientific
Officer from March 13, 2016 through August 25, 2006. He was the Chief Scientific Officer at Tacora Corporation from 1994 to 1997 and was
the Vice-President, R&D, at Access Pharmaceuticals from 1997 to 1998. Dr. Wilson was Research Area Head, Cell and Molecular Biology
in Advanced Drug Delivery at Ciba-Geigy Pharmaceuticals from 1984 – 1989 and Worldwide Head of Drug Delivery at SmithKline Beecham
from 1989 to 1994. He was a faculty member at Rockefeller University, New York, in the laboratory of the Nobel Laureates, Sanford Moore
and William Stein, from 1974 to 1979. Dr. Wilson is a recognized leader in the development of drug delivery systems and has been involved
in taking lead products & technologies from concept to commercialization. Dr. Wilson has a Ph. D. in Biochemistry and conducted medical
research at The Rockefeller University, New York.

 We believe that Dr. Wilson's extensive background
of success in corporate management and product development, with tenures in both multinational and start-up biotech organizations, will
assist us as we work to complete our drug development and commercialization activities.

 Steven Zelenkofske, D.O.

 Dr. Steven Zelenkofske has served on our Board
of Directors since January 2023. Dr. Zelenkofske has served on the Board of Directors of Dinaqor AG since May 2020. He is currently serving
as President of SLZ Consulting, LLC. He has served as Chief Medical Officer of SwanBio Therapeutics since June 1, 2020 until September
2022. Dr. Zelenkofske is also an advisor to Veralox Therapeutics, Inc., as Chair of the Scientific Advisory Board, a position he has held
since March 2020. Previously, he served as Executive Vice President and Chief Medical Officer of Achillion Pharmaceuticals, Inc. from
August 2018 until April 2020. Dr. Zelenkofske also served as Chief Medical Officer of uniQure N.V., from June 2017 to August 2018. Prior
to joining uniQure, N.V., Dr. Zelenkofske was Vice President and Therapeutic Head of Cardiovascular/Metabolism for AstraZeneca, a biopharmaceutical
company, from November 2014 to June 2017. From January 2009 to November 2014, Dr. Zelenkofske was Senior Vice President Clinical and Medical
Affairs and Chief Medical Officer of Regado Biosciences, Inc., a biotechnology company. Dr. Zelenkofske has held leadership positions
at Sanofi-Aventis, Boston Scientific, a medical device company, and Novartis Pharmaceuticals, a global healthcare company. Dr. Zelenkofske
holds Bachelor of Science and Master of Science degrees from Emory University and a Doctor of Osteopathic Medicine degree from the Philadelphia
College of Osteopathic Medicine. He conducted his graduate medical education at the Philadelphia College of Osteopathic Medicine and is
board-certified in internal medicine, cardiology and cardiac electrophysiology. We believe that Dr. Zelenkofske is qualified to serve
on our Board of Directors due to his knowledge and experience working in the biotech and pharmaceutical space will assist us as we work
to complete our drug development and commercialization activities.

 Selection of Officers

 Our executive officers serve at the discretion
of our Board of Directors. There are no familial relationships among our directors and executive officers.

 Board Composition

 Pursuant to our amended and restated certificate
of incorporation, our Board of Directors is divided into three classes — Class I, Class II, and Class III — with each class
serving staggered three-year terms and subject to the terms of our amended and restated certificate of incorporation and amended and
restated bylaws, our Board of Directors consists of five members, as a classified board of directors. As a result, only one class of
directors will be elected at each annual meeting of our stockholders, with the other classes continuing for the remainder of their respective
three-year terms. The terms of the directors will expire upon the election and qualification of successor directors at the annual meeting
of stockholders to be held during 2024 for the Class II directors, 2025 for the Class III directors and 2026 for the Class I directors.
Our directors are divided among the three classes as follows:

 the Class I directors are
 Quang X. Pham and Glynn Wilson and their terms will expire at the annual meeting of stockholders to be held in 2026;

 the Class II directors
 are Robert Lisicki and John Murphy and their terms will expire at the annual meeting of stockholders to be held in 2027; and

 the Class III director
 is Steven Zelenkofske and his term will expire at the annual meeting of stockholders to be held in 2025.

 Upon expiration of the term of a class of directors,
new directors for that class will be elected for three-year terms at the annual meeting of stockholders during the year in which that
term expires. Each director's term shall continue until the election and qualification of his or her successor, or the director's
earlier death, resignation or removal. Any additional directorships resulting from an increase in the number of authorized directors
will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors.

 The classification of our Board of Directors
may have the effect of delaying or preventing a change of our management, a change of control or other corporate actions. Under Delaware
law, our amended and restated certificate of incorporation our directors may be removed only for cause.

 Director Independence

 Under the rules of the Nasdaq Stock Market, independent directors must
comprise a majority of our Board of Directors. The rules of the Nasdaq Stock Market, as well as those of the SEC, impose several requirements
with respect to the independence of our directors. Our Board of Directors has conducted a review of its proposed composition, the composition
of its proposed committees and the independence of each director in accordance with these rules. Based upon information requested from
and provided by each director concerning his background, employment and affiliations, including family relationships, our Board of Directors
has determined that Robert Lisicki, John R. Murphy, Dr. Steven Zelenkofske, and Dr. Glynn Wilson do not have relationships that would
interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these directors
is "independent" as that term is defined under the rules of the Nasdaq Stock Market and the SEC. In making this determination,
our Board of Directors considered relationships that each director has with the Company, including the transactions described under the
section entitled "Certain Relationships and Related Party Transactions."

 Committees of the Board of Directors

 Our Board of Directors has established an Audit
Committee, a Compensation Committee and a Nominating and Corporate Governance Committee, each of which has the composition and responsibilities
described below. Each committee operates under a written charter that satisfies the applicable rules of the SEC and the listing standards
of the Nasdaq Stock Market, copies of which are available on our website at www.cadrenal.com. Members will serve on these committees
until their resignation or until otherwise determined by our Board of Directors. From time to time, our Board of Directors may establish
other committees to facilitate the management of our business as it sees fit and in accordance with applicable law and our corporate
governance documents.

 The following table shows the directors who are
currently members or Chairman of each of the Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee.

 Board Members

 Audit
 Committee

 Committee

 Nominating
 and
 Governance
 Committee

 —

 —

 —

 —

 John Murphy

 Chair

 —

 Glynn Wilson

 —

 Chair

 Steven Zelenkofske

 Chair

 Audit Committee. Our Audit Committee
consists of John Murphy, Dr. Steven Zelenkofske and Dr. Glynn Wilson, with John Murphy serving as the Chair of the Audit Committee. Our
Board of Directors has determined that all of the directors who serve on our Audit Committee are independent within the meaning of the
rules and regulations of the Nasdaq Stock Market and Rule 10A-3 under the Exchange Act. In addition, our Board of Directors has determined
that John Murphy qualifies as an audit committee financial expert within the meaning of SEC regulations and meets the financial sophistication
requirements of the Nasdaq Stock Market. The primary purpose of the audit committee is to oversee the quality and integrity of our accounting
and financial reporting processes and the audit of our financial statements. Specifically, the audit committee will:

 select and hire the independent
 registered public accounting firm to audit our financial statements;

 help to ensure the independence
 and performance of the independent registered public accounting firm;

 approve audit and non-audit
 services and fees;

 review financial statements
 and discuss with management and the independent registered public accounting firm our annual audited and quarterly financial statements,
 the results of the independent audit and the quarterly reviews and the reports and certifications regarding internal controls over
 financial reporting and disclosure controls;

 prepare the audit committee
 report that the SEC requires to be included in our annual proxy statement;

 review reports and communications
 from the independent registered public accounting firm;

 review the adequacy and
 effectiveness of our internal controls and disclosure controls and procedure;

 review our policies on
 risk assessment and risk management;

 review and approve related
 party transactions; and

 establish and oversee procedures
 for the receipt, retention and treatment of accounting related complaints and the confidential submission by our employees of concerns
 regarding questionable accounting or auditing matters.

 Compensation Committee. Our Compensation
Committee consists of Dr. Steven Zelenkofske, Robert Lisicki, and John Murphy, with Dr. Steven Zelenkofske serving as the Chair of the
Compensation Committee. Our Board of Directors has determined that all of the directors who serve on our compensation committee are independent
under the listing standards, are "non-employee directors" as defined in rule 16b-3 promulgated under the Exchange Act and
are "outside directors" as that term is defined in Section 162(m) of the Internal Revenue Code of 1986, as amended, or the
Code. Our compensation committee oversees our compensation policies, plans and benefits programs. The compensation committee will also:

 oversee our overall compensation
 philosophy and compensation policies, plans and benefit programs;

 review and recommend to
 our board of directors for approval compensation for our executive officers and directors;

 prepare the compensation
 committee report that the SEC would require to be included in our annual proxy statement if we were no longer deemed to be an emerging
 growth company or a smaller reporting company; and

 administer our equity compensation
 plans.

 Nominating and Corporate Governance Committee.
 Our Nominating and Corporate Governance Committee consists of Dr. Glynn Wilson, Robert Lisicki and Dr. Steven Zelenkofske, with
Dr. Glynn Wilson serving as the Chair of the Nominating and Corporate Governance Committee. The Nominating and Corporate Governance Committee
oversees and assists our Board of Directors in reviewing and recommending nominees for election as directors. All members who serve on
the Nominating and Corporate Governance Committee are independent directors as defined under the listing standards of the Nasdaq Stock
Market. Specifically, the corporate governance and nominating committee will:

 identify, evaluate and
 make recommendations to our board of directors regarding nominees for election to our board of directors and its committees, including
 consideration of recommendations for election to the Board of Directors by stockholders if submitted in a timely manner in accordance
 with the procedures set forth in our bylaws;

 consider and make recommendations
 to our board of directors regarding the composition of our board of directors and its committees;

 review developments in
 corporate governance practices;

 evaluate the adequacy of
 our corporate governance practices and reporting; and

 evaluate the performance
 of our board of directors and of individual directors.

 Candidates for director should have certain minimum
qualifications, including the ability to understand basic financial statements, being over 21 years of age, having relevant business
experience (taking into account the business experience of the other directors), and having high moral character. The Nominating and
Corporate Governance Committee retains the right to modify these minimum qualifications from time to time.

 In evaluating an incumbent director whose term
of office is set to expire, the Nominating and Corporate Governance Committee reviews such director's overall service to the Company
during such director's term, including the number of meetings attended, level of participation, quality of performance, and any
transactions with the Company engaged in by such director during his term.

 When selecting a new director nominee, the Nominating
and Corporate Governance Committee first determines whether the nominee must be independent for Nasdaq purposes or whether the candidate
must qualify as an "audit committee financial expert." The Nominating and Corporate Governance Committee then uses its network
of contacts to compile a list of potential candidates, but may also engage, if it deems appropriate, a professional search firm to assist
in the identification of qualified director candidates. The Nominating and Corporate Governance Committee also will consider nominees
recommended by our stockholders. The Nominating and Corporate Governance Committee does not distinguish between nominees recommended
by our stockholders and those recommended by other parties. The Nominating and Corporate Governance Committee evaluates the suitability
of potential nominees, taking into account the current board composition, including expertise, diversity and the balance of inside and
independent directors. The Nominating and Corporate Governance Committee does not have a set policy or process for considering diversity
in identifying nominees, but endeavors to establish a diversity of background and experience in a number of areas of core competency,
including business judgment, management, accounting, finance, knowledge of our industry, strategic vision, research and development and
other areas relevant to our business. In considering any person recommended by one of our stockholders, the Nominating and Corporate
Governance Committee will look for the same qualifications that it looks for in any other person that it is considering for a position
on the Board of Directors.

 Compensation Committee Interlocks and Insider
Participation

 No member of our Compensation Committee will
be serving, or will have ever served, as an officer or employee of ours. None of our executive officers currently serves, or has served
during the last completed year, as a member of the Board of Directors, Compensation Committee or other board committee performing equivalent
functions of any entity that has one or more executive officers who served as a member of our Board of Directors during the last completed
year.

 Delinquent Section 16(a) Reports

 Section 16(a) of the Exchange Act
requires our directors and executive officers, and persons who own more than ten percent of a registered class of our equity securities,
to file with the SEC initial reports of ownership and reports of changes in ownership of our Common Stock and our other equity securities.
Officers, directors and greater than ten percent stockholders are required by SEC regulation to furnish us with copies of all Section 16(a) forms
they file.

 To our knowledge, based solely on a review of
the copies of such reports furnished to us and written representations that no other reports were required, during the fiscal year ended
December 31, 2024, all Section 16(a) filing requirements applicable to our officers, directors and greater than ten percent
beneficial owners were complied with other than a late Form 3 filed on April 3, 2024 by Jeffrey Cole upon his employment and
one Form 4 filed on February 12, 2024 by Quang Pham with respect to one transaction.

 Code of Business Conduct and Ethics

 We have adopted a code of business conduct and
ethics (the "Code of Ethics") that is applicable to all of our employees, officers and directors. The full text of our Code
of Ethics is available on our website at www.cadrenal.com. If we amend or grant any waiver of a provision of our Code of Ethics
that applies to our directors or executive officers, we will publicly disclose such amendment or waiver on our website and as required
by applicable law. The information on the website is not and should not be considered part of this Annual Report and is not incorporated
by reference in this Annual Report.

 Insider Trading Policy

 We have adopted an insider trading policy (the "Trading Policy")
that is designed to promote compliance with federal securities laws, rules and regulations, as well as the rules and regulations of the
Nasdaq Stock Market. The Trading Policy provides Cadrenal's standards on trading and causing the trading of our securities or securities
of other publicly traded companies while in possession of confidential information. It prohibits trading in certain circumstances and
applies to us and all of our directors, officers and employees as well as independent contractors or consultants who have access to material
nonpublic information of Cadrenal. Additionally, our Trading Policy imposes special additional trading restrictions applicable to all
of our directors and executive officers. The Trading Policy is annexed to this Annual Report as an exhibit and the full text of the Trading
Policy is available on our website at www.cadrenal.com.

 Limitation of Liability and Indemnification

 Our amended and restated bylaws provide indemnification
for our directors and executive officers to the fullest extent permitted by the Delaware General Corporation Law. The indemnification
agreements that we have entered into with each of our current executive officers and directors may, in some cases, be broader than the
specific indemnification provisions contained under Delaware law.

 In addition, as permitted by Delaware law, our
amended and restated certificate of incorporation includes provisions that eliminate the personal liability of our directors and officers
for monetary damages resulting from breaches of certain fiduciary duties as a director or officer, as applicable, except to the extent
such an exemption from liability thereof is not permitted under the Delaware General Corporation Law. The effect of these provisions
is to restrict our rights and the rights of our stockholders in derivative suits to recover monetary damages against a director or officer
for breach of fiduciary duties as a director or officer, subject to certain exceptions in which case the director or officer would be
personally liable. An officer may not be exculpated for any action brought by or in the right of the corporation. A director may not
be exculpated for improper distributions to stockholders. Further, pursuant to Delaware law a director or officer may not be exculpated
for:

 any
breach of his or her duty of loyalty to us or to our stockholders;

 acts
or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; and

 any
transaction from which the director or officer derived an improper personal benefit.

 If Delaware law is amended to authorize corporate
action further eliminating or limiting the personal liability of directors and officers, then the liability of our directors and officers
will be eliminated or limited to the fullest extent permitted by Delaware law, as so amended. Our certificate of incorporation does not
eliminate the duty of care owed by our directors and officers and, in appropriate circumstances, equitable remedies, such as injunctive
or other forms of non-monetary relief, remain available under Delaware law. This provision also does not affect the responsibilities
of directors and officers under any other laws, such as the federal securities laws or other state or federal laws. Under our amended
and restated bylaws, we will also be empowered to purchase insurance on behalf of any person whom we are required or permitted to indemnify.

 In the case of an action or proceeding by or
in the right of our company or any of our subsidiaries, no indemnification will be provided for any claim where a court determines that
the indemnified party is prohibited from receiving indemnification. We believe that these charter and bylaw provisions are necessary
to attract and retain qualified persons as directors and officers.

 The limitation of liability and indemnification
provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from
bringing a lawsuit against directors and officers for breach of their fiduciary duties. They may also reduce the likelihood of derivative
litigation against directors and officers, even though an action, if successful, might benefit us and our stockholders. Moreover, a stockholder's
investment may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these
indemnification provisions.

 Insofar as indemnification for liabilities arising
under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing provisions, or
otherwise, we have been advised that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities
Act, and is, therefore, unenforceable. There is no pending litigation or proceeding naming any of our directors or officers as to which
indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification
by any director or officer.

 We have entered into separate indemnification
agreements with each of our current executive officers and intend to enter, into separate indemnification agreements with each of our
directors and executive officers, in addition to the indemnification that will be provided for in our amended and restated bylaws. The
indemnification agreements and our amended and restated bylaws require us to indemnify our directors and executive officers to the fullest
extent permitted by Delaware law. See the section titled "Description of Securities — Limitations on Liability and Indemnification
of Officers and Directors" for additional information.

 Item 11. Executive Compensation.

 Our named executive officers for the year ended December 31, 2024,
which consist of our principal executive officer and the next two most highly compensated executive officers, are:

 Quang X. Pham, Chairman and Chief Executive Officer

 Matthew Szot, Chief Financial
 Officer

 Jeffrey Cole, Chief Operating Officer

 Summary Compensation Table

 The following table shows compensation awarded
to or earned by our named executive officers, for the fiscal year ended December 31, 2024 and 2023.

 Name and Principal Position

 Year

 Salary
 ($)

 Bonus
 ($) (1)

 Stock Award
 ($) (2)

 Option Awards ($) (2)

 Non-Equity
 Incentive
 Plan
 ($)

 All Other
 ($)

 Total
 ($)

 2024

 $
 708,750

 $
 407,531

 —

 $
 93,300

 —

 $
 13,800
 (3)

 $
 1,223,381

 Chief Executive Officer

 2023

 $
 662,500

 $
 292,950

 —

 —

 —

 $
 11,550
 (3)

 $
 967,000

 2024

 $
 435,850

 $
 263,126

 —

 $
 155,503

 —

 13,800
 (4)

 $
 868,279

 Chief Financial Officer

 2023

 $
 377,180

 $
 184,053

 $
 250,000

 —

 —

 $
 33,657
 (4)

 $
 844,890

 2024

 363,721

 160,380

 —

 $
 154,950

 —

 $
 47,250
 (5)

 $
 726,301

 Chief Operating Officer

 2023

 —

 —

 —

 —

 —

 $
 24,875
 (5)

 $
 24,875

 (1)

 Bonuses for 2024 were accrued as of December 31, 2024, but such bonuses
were paid in the first quarter of 2025. Bonuses for 2023 were accrued as of December 31, 2023, but such bonuses were paid in February
2024.

 (2)

 In accordance with SEC
 rules, this column reflects the aggregate fair value of the stock and option awards granted as of their respective grant dates in
 accordance with Financial Accounting Standard Board Accounting Standards Codification Topic 718 for stock-based compensation transactions
 (ASC 718). The valuation assumptions used in determining such amounts are described in Note 1 and Note 7 to our audited financial
 statements included elsewhere in this Annual Report. These amounts do not correspond to the actual value that may be realized by
 the Named Executive Officers upon vesting or exercise of such awards.

 (3)

 All other compensation for Mr. Pham included $13,800 and $11,550 of
401K employer match contributions for 2024 and 2023, respectively.

 (4)

 All other compensation for Mr. Szot in 2024 included $13,800 of 401K
employer match contributions. All other compensation for Mr. Szot in 2023 included $12,888 of 401K employer match contributions and $20,769
of consulting fees prior to the Company's IPO.

 (5)

 All other compensation for Mr. Cole in 2024 included $13,500 of 401K
employer match contributions and $33,750 of consulting fees earned prior to his appointment as Chief Operating Officer effective February
8, 2024. All other compensation for 2023 represents $24,875 of consulting fees.

 Agreements with Our Named Executive Officers

 Quang X. Pham Employment Agreement

 We entered into an employment agreement with Quang X. Pham, our Chief
Executive Officer, on March 1, 2022. Mr. Pham's employment is at-will. Mr. Pham's annual base salary pursuant to the employment
agreement was initially $420,000, which increased to $675,000 upon the completion of our initial public offering. On January 1, 2024,
his salary was increased to $708,750 and on January 1, 2025, his salary was increased to $751,275. Mr. Pham is eligible for an annual
target bonus of up to 50% of his base salary, with the actual amount of the bonus, if any, based upon the achievement by Mr. Pham and
us of the applicable performance targets and goals as set by our board of directors or our compensation committee, with individual performance
targets determined in consultation with Mr. Pham.

 Pursuant to Mr. Pham's employment agreement,
we will need to provide 90 days' written notice to terminate his employment without cause. If Mr. Pham resigns for Good Reason,
as such term is defined in the employment agreement, or is terminated without cause (as such terms are defined below), he is entitled
to (i) a lump sum payment equal to 24 months of his base salary, (ii) a lump sum payment equal to his target bonus for the calendar year
in which his termination date occurs, (iii) full acceleration of any outstanding equity or equity-based awards that he has with respect
to us or any of our affiliates as of his termination date, (iv) extension of exercisability for the full term of any stock option, and
(v) payment of his full COBRA premiums for 24 months following his termination date, if applicable conditions are met.

 Mr. Pham is required to provide us 90 days'
written notice of the condition that qualifies as a Good Reason for his resignation and we will have 30 days from receipt of such notice
to remedy such condition. If Mr. Pham fails to provide the required notice such that we have the opportunity to cure the condition prior
to his resignation, or if he resigns more than nine months after the initial existence of the condition, his resignation shall not be
deemed for Good Reason.

 If we terminate Mr. Pham's employment for
Cause, as such term is defined in the employment agreement, or if Mr. Pham voluntarily terminates his employment without Good Reason
upon 30 days written notice to us, Mr. Pham shall be entitled to receive Accrued Obligations, as such term is defined in the employment
agreement and which includes earned, but unpaid, base salary, accrued, but unused, vacation, and vested benefits, as of the date of termination.

 Pursuant to Mr. Pham's employment agreement,
if his employment is terminated due to his death or disability (as defined in the employment agreement), he is entitled to (i) a lump
sum payment equal to twelve months of his base salary, (ii) full acceleration of any outstanding equity or equity-based awards that he
has with respect to us or any of our affiliates as of his termination date, and (iii) Accrued Obligations.

 Matthew Szot Employment Agreement

 Upon completion of the initial public offering, we entered into an
employment agreement with Matthew Szot, our Chief Financial Officer, dated January 24, 2023. He initially received an annual salary of
$375,000, which was increased to $415,000 effective June 1, 2023, $435,750 effective January 1, 2024 and $459,716 effective January 1,
2025. Mr. Szot is eligible for an annual target bonus of up to 50% of his base salary, with the actual amount of the bonus, if any, based
upon the achievement of Mr. Szot and us of the applicable performance targets and goals as set by our board of directors.

 Pursuant to Mr. Szot's employment agreement,
we will need to provide 90 days' written notice to terminate his employment without Cause, as such term is defined in the employment
agreement. If Mr. Szot resigns for Good Reason, as such term is defined in the employment agreement, or is terminated without Cause,
unrelated to a Change of Control, as such term is defined in the employment agreement, he is entitled to (i) continuation of his base
salary in effect immediately prior to termination for a period of 12 months, (ii) a lump sum payment equal to his target bonus for the
calendar year in which his termination date occurs, (iii) full acceleration of any outstanding equity or equity-based awards as of his
termination date, (iv) extension of exercisability for the full term of any stock option, and (v) payment of his full COBRA premiums
for 12 months following his termination date, if applicable conditions are met.

 Mr. Szot will be required to provide us 90 days'
written notice of the condition that qualifies as a Good Reason for his resignation and we will have 30 days from receipt of such notice
to remedy such condition. If Mr. Szot fails to provide the required notice such that we do not have the opportunity to cure the condition
prior to his resignation, or if he resigns more than nine months after the initial existence of the condition, his resignation shall
not be deemed for Good Reason.

 If at any time during a Change of Control Period,
as such term is defined in the employment agreement, Mr. Szot's employment is terminated without Cause or Mr. Szot resigns for
Good Reason, he is entitled to: (i) a lump sum payment equal to 12 months of his base salary in effect immediately prior to termination
plus his target bonus for the fiscal year in which his termination date occurs; (ii) full acceleration of any outstanding equity or equity-based
awards as of his termination date; (iii) extension of exercisability for the full term of any stock option; and payment of his full COBRA
premiums for 12 months following his termination date, if applicable conditions are met.

 If we terminate Mr. Szot's employment for
Cause, or if Mr. Szot voluntarily terminates his employment without Good Reason upon 30 days written notice to us, Mr. Szot shall be
entitled to receive Accrued Obligations, as such term is defined in the employment agreement, as of the date of termination.

 Pursuant to Mr. Szot's employment agreement,
if his employment is terminated due to his death or Disability (as defined in the employment agreement), he is entitled to (i) a lump
sum payment equal to twelve months of his base salary, (ii) full acceleration of any outstanding equity or equity-based awards that he
has with respect to us or any of our affiliates as of his termination date; and (iii) Accrued Obligations.

 Douglas Losordo Employment Agreement

 Upon completion of the initial public offering, we entered into an
employment agreement with Douglas Losordo, effective January 24, 2023. Under the employment agreement, Dr. Losordo continued to serve
as our Chief Medical Officer until February 4, 2025. He initially received an annual base salary of $425,000, which was increased to $435,625
effective January 1, 2024 and increased to $457,406 effective January 1, 2025, with an annual targeted cash bonus of 40% of his base salary.

 On February 4, 2025,
we terminated our employment relationship with Douglas Losordo, on a mutual amicable basis. On February 7, 2025, we entered into a severance
and release letter agreement (the "Severance Agreement"), with Dr. Losordo. Pursuant to the Severance Agreement, Dr. Losordo
will receive (i) a continuation of his base salary for six months, (ii) a lump sum payment equal to 50% of his annual target cash bonus
for fiscal 2025, (iii) reimbursement of COBRA premiums for up to six (6) months, and (iv) accelerated vesting of all outstanding options
issued to him, which shall remain exercisable until their original expiration date. Within seven days of Dr. Losordo's execution
of the Severance Agreement, he could have revoked the terms thereof. Therefore, the Severance Agreement was not effective or enforceable
until the seven-day revocation period expired. The Severance Agreement contains a general release of all claims against us and our current
and former officers, directors, employees and agents, and a non-disparagement clause relating to us or any released party.

 Jeffrey Cole Employment Agreement

 On February 12, 2024, we entered into an employment
agreement with Jeffrey Cole, our Chief Operating Officer, effective February 8, 2024. He initially received an annual salary of $405,000,
which was increased to $425,250 effective January 1, 2025. Mr. Cole is eligible for an annual target bonus of up to 40% of his base salary,
with the actual amount of the bonus, if any, based upon the achievement of Mr. Cole and us of the applicable performance targets and goals
as set by our board of directors.

 Pursuant to Mr. Cole's employment agreement,
we will need to provide 90 days' written notice to terminate his employment without Cause, as such term is defined in the employment
agreement. If Mr. Cole resigns for Good Reason, as such term is defined in the employment agreement, or is terminated without Cause, unrelated
to a Change of Control, as such term is defined in the employment agreement, he is entitled to (i) continuation of his base salary in
effect immediately prior to termination for a period of 12 months, (ii) a lump sum payment equal to his target bonus for the calendar
year in which his termination date occurs, (iii) full acceleration of any outstanding equity or equity-based awards as of his termination
date, (iv) extension of exercisability for the full term of any stock option, and (v) payment of his full COBRA premiums for 12 months
following his termination date, if applicable conditions are met.

 Mr. Cole will be required to provide us 90 days'
written notice of the condition that qualifies as a Good Reason for his resignation and we will have 30 days from receipt of such notice
to remedy such condition. If Mr. Cole fails to provide the required notice such that we do not have the opportunity to cure the condition
prior to his resignation, or if he resigns more than 15 days after expiration of our 30 day period to remedy the condition, his resignation
shall not be deemed for Good Reason.

 If at any time during a Change of Control Period,
as such term is defined in the employment agreement, Mr. Cole's employment is terminated without Cause or Mr. Cole resigns for Good
Reason, he is entitled to: (i) a lump sum payment equal to 12 months of his base salary in effect immediately prior to termination plus
his target bonus for the fiscal year in which his termination date occurs; (ii) full acceleration of any outstanding equity or equity-based
awards as of his termination date; (iii) extension of exercisability for the full term of any stock option; and payment of his full COBRA
premiums for 12 months following his termination date, if applicable conditions are met.

 If we terminate Mr. Cole's employment for
Cause, or if Mr. Cole voluntarily terminates his employment without Good Reason upon 30 days written notice to us, Mr. Cole shall be entitled
to receive Accrued Obligations, as such term is defined in the employment agreement, as of the date of termination.

 Pursuant to Mr. Cole's employment agreement,
if his employment is terminated due to his death or Disability (as defined in the employment agreement), he is entitled to (i) a lump
sum payment equal to twelve months of his base salary, (ii) full acceleration of any outstanding equity or equity-based awards that he
has with respect to us or any of our affiliates as of his termination date; and (iii) Accrued Obligations.

 James Ferguson Employment Agreement

 On February 4, 2025, we entered into an employment
agreement with James Ferguson, our Chief Medical Officer, effective as of February 5, 2025, which provides for: (i) an annual salary of
$505,000, (ii) a discretionary annual target bonus of up to 40% of his base salary, with the actual amount of the bonus, if any, based
upon the achievement of Dr. Ferguson and us of the applicable performance targets and goals as set by our board of directors; and (iii)
a stock option award for 60,000 shares of our Common Stock, which options shall vest 25% on March 1, 2026, with the balance vesting pro
rata over thirty-six (36) months. Dr. Ferguson is also bound by confidentiality provisions.

 If, after the six month anniversary, but prior
to the one year anniversary, of the effective date of Dr. Ferguson's employment agreement, such agreement is terminated by us without
Cause or by Dr. Ferguson for Good Reason (as such terms are defined in the employment agreement), Dr. Ferguson will be entitled to receive
continuation of payment of his base salary and the payment of his COBRA premiums for a period of six months. On or after the one-year
anniversary of the effective date of Dr. Ferguson's employment agreement, if such agreement is terminated by us without Cause or
by Dr. Ferguson for Good Reason, he will be entitled to receive continuation of payment of his base salary and the payment of his COBRA
premiums for a period of 12 months.

 Dr. Ferguson will be required to provide us 90
days' written notice of the condition that qualifies as a Good Reason for his resignation and we will have 30 days from receipt
of such notice to remedy such condition. If Dr. Ferguson fails to provide the required notice such that we do not have the opportunity
to cure the condition prior to his resignation, or if he resigns more than 15 days after expiration of our 30 day period to remedy the
condition, his resignation shall not be deemed for Good Reason.

 If at any time during a Change of Control Period,
as such term is defined in the employment agreement, Dr. Ferguson's employment is terminated without Cause or Dr. Ferguson resigns
for Good Reason, he is entitled to: (i) a lump sum payment equal to 12 months of his base salary in effect immediately prior to termination
plus his target bonus for the fiscal year in which his termination date occurs; (ii) full acceleration of any outstanding equity or equity-based
awards as of his termination date; (iii) extension of exercisability for the full term of any stock option; and payment of his full COBRA
premiums for 12 months following his termination date, if applicable conditions are met.

 If we terminate Dr. Ferguson's employment
for Cause, or if Dr. Ferguson voluntarily terminates his employment without Good Reason upon 30 days written notice to us, Dr. Ferguson
shall be entitled to receive Accrued Obligations, as such term is defined in the employment agreement, as of the date of termination.

 Pursuant to Dr. Ferguson's employment agreement,
if his employment is terminated due to his death or Disability (as defined in the employment agreement), he is entitled to (i) a lump
sum payment equal to twelve months of his base salary, (ii) full acceleration of any outstanding equity or equity-based awards that he
has with respect to us or any of our affiliates as of his termination date; and (iii) Accrued Obligations.

 Outstanding Equity Awards at Fiscal Year End

 The following table sets forth information concerning
the number of shares of Common Stock underlying outstanding equity incentive awards for each of our named executive officers as of December
31, 2024:

 Option Awards

 Stock Awards

 Name

 Grant
 Date

 Securities
 Underlying
 Unexercised
 Options
 Exercisable (#)

 Securities
 Underlying
 Unexercised
 Options
 Unexercisable (#)

 Option
 Price
 ($)

 Option
 Expiration
 Date

 Shares or
 Units of
 Stock
 not yet
 Vested
 (#)

 Market
 Value of
 Shares or
 Units
 not yet
 Vested
 ($)

 01/18/2024 (1)

 —

 10,000

 14.10

 01/17/2034

 01/18/2024 (1)

 —

 16,667

 14.10

 01/17/2034

 07/11/2022 (2)

 3,333

 —

 9.60

 07/10/2032

 01/18/2024 (1)

 —

 10,000

 14.10

 01/17/2034

 04/02/2024 (3)

 —

 10,000

 9.30

 04/01/2034

 (1)

 These options vest 25% on February 1, 2025 and thereafter pro rata
on a monthly basis for the next 36 months.

 (2)

 These options vested monthly for one year and are fully vested.

 (3)

 These options vest 25% on April 1, 2025 and thereafter pro rata on
a monthly basis for the next 36 months.

 Equity Incentive Plans

 2022 Successor Equity Incentive Plan

 In October 2022, the Board adopted, and our stockholders
approved, the 2022 Plan, as a successor to and continuation of the Initial Plan, which became effective on January 19, 2023, upon the
effectiveness of the Registration Statement. All outstanding awards under the Initial Plan remain outstanding but no further grants will
be made under the Initial Plan. The shares of Common Stock underlying any awards under the 2022 Plan and the Initial Plan that are forfeited,
canceled or otherwise terminated, other than by exercise, will be added back to the shares of Common Stock available for issuance under
the 2022 Plan. In addition, if any shares subject to an award under the 2022 Plan and the Initial Plan are tendered or withheld by the
Company to satisfy any exercise price or tax withholding obligation, such tendered or withheld shares will be added back to the shares
of Common Stock available for issuance under the 2022 Plan. Shares of Common Stock repurchased on the open market will not be added back
to the shares of Common Stock available for issuance under the 2022 Plan. The principal purpose of the 2022 Plan is to attract, retain
and incentivize the Company's employees and other service providers through the granting of certain stock-based awards, including
performance-based awards. The material terms of the 2022 Plan are summarized below.

 Administration

 The 2022 Plan vests broad powers in a committee
to administer and interpret the 2022 Plan. Our board of directors has initially designated the compensation committee to administer the
2022 Plan. Except when limited by the terms of the 2022 Plan, the compensation committee has the authority to, among other things: select
the persons to be granted awards; determine the type, size and term of awards; establish performance objectives and conditions for earning
awards; determine whether such performance objectives and conditions have been met; and accelerate the vesting or exercisability of an
award. In its discretion, the compensation committee may delegate all or part of its authority and duties with respect to granting awards
to one or more of our officers, subject to certain limitations and provided applicable law so permits.

 Our board of directors may amend, alter or discontinue
the 2022 Plan and the compensation committee is able to amend any outstanding award at any time; provided, however, that no such amendment
or termination may adversely affect awards then outstanding without the holder's permission. In addition, any amendments seeking
to increase the total number of shares reserved for issuance under the 2022 Plan or modifying the classes of participants eligible to
receive awards under the 2022 Plan requires ratification by our stockholders in accordance with applicable law. Additionally, as described
more fully below, neither the compensation committee nor the board of directors is permitted to reprice outstanding options or stock
appreciation rights without shareholder consent.

 Eligibility

 Any of our employees, directors, and consultants,
or those of our affiliates, are eligible to participate in the 2022 Plan and may be selected by the compensation committee to receive
an award.

 Vesting

 The compensation committee determines the vesting
conditions for awards. These conditions may include the continued employment or service of the participant, the attainment of specific
individual or corporate performance goals, or other factors as determined in the compensation committee's discretion (collectively,
"Vesting Conditions").

 Shares of Stock Available for Issuance

 The maximum number of shares of Common Stock that
may be issued under the 2022 Plan will automatically increase on January 1 of each calendar year for a period of ten years commencing
on January 1, 2024 and ending on (and including) January 1, 2033, pursuant to an "evergreen" provision contained therein,
to a number of shares of Common Stock equal to 20% of the aggregate of: (i) the number of shares of Common Stock outstanding on December
31 of the preceding calendar year, plus (ii) the number of shares issuable upon exercise of outstanding warrants and pre-funded warrants
on December 31 of the preceding calendar year; provided, however that the board of directors, or the compensation committee, may act prior
to January 1 of a given calendar year to provide that the increase for such year will be a lesser number of shares of Common Stock. On
January 1, 2025, the shares available under the 2022 Plan increased by 172,716 shares pursuant to the "evergreen" provision
to a maximum of 479,685 shares. As of the date of this Annual Report, there are 40,019 shares available for future issuance under the
2022 Plan. All available shares may be utilized toward the grant of any type of award under the 2022 Plan. The 2022 Plan imposes a $100,000
limitation on the total grant date fair value with respect to which incentive stock options are exercisable for the first time by an individual
optionee during any single calendar year.

 In the event of any merger, consolidation, sale
or disposition of all or substantially all our assets, sale or disposition of at least 50% of our outstanding securities, or other similar
corporate transaction that affects our Common Stock, the board of directors or compensation committee shall make adjustments to the number
and kind of shares authorized by the 2022 Plan and covered under outstanding 2022 Plan awards as it determines appropriate and equitable.

 Shares subject to 2022 Plan awards that expire
without being fully exercised or that are otherwise forfeited, cancelled or terminated may again be made available for issuance under
the 2022 Plan. In addition, shares withheld in settlement of a tax withholding obligation, or in satisfaction of the exercise price payable
upon exercise of an option, will again become available for issuance under the 2022 Plan.

 Types of Awards

 The following types of awards may be granted
to participants under the 2022 Plan: (i) incentive stock options, or ISOs; (ii) nonqualified stock options, or NQOs and together with
ISOs, options, (iii) stock appreciation rights, (iv) restricted stock, or (v) restricted stock units.

 Stock Options. An option entitles the holder
to purchase from us a stated number of shares of Common Stock. An ISO may only be granted to an employee of ours or our eligible affiliates.
The compensation committee will specify the number of shares of Common Stock subject to each option and the exercise price for such option,
provided that the exercise price may not be less than the fair market value of a share of Common Stock on the date the option is granted.
Notwithstanding the foregoing, if ISOs are granted to any 10% stockholder, the exercise price shall not be less than 110% of the fair
market value of Common Stock on the date the option is granted.

 Generally, options may be exercised in whole or
in part through a cash payment. The compensation committee may, in its sole discretion, permit payment of the exercise price of an option
pursuant to a "cashless exercise," in the form of previously owned shares of Common Stock based on the fair market value of
the shares on the date the option is exercised, or through means of "net settlement," which involves the cancellation of a
portion of the option to cover the cost of exercising the balance of the option or by such other means as it deems acceptable.

 All options shall be or become exercisable in
accordance with the terms of the applicable award agreement. The maximum term of an option shall be determined by the compensation committee
on the date of grant but shall not exceed 10 years (5 years in the case of ISOs granted to any 10% stockholder). In the case of ISOs,
the aggregate fair market value (determined as of the date of grant) of Common Stock with respect to which such ISOs become exercisable
for the first time during any calendar year cannot exceed $100,000. ISOs granted in excess of this limitation will be treated as non-qualified
stock options.

 Stock Appreciation Rights. A stock appreciation
right represents the right to receive, upon exercise, any appreciation in a share of Common Stock over a particular time period. The base
price of a stock appreciation right shall not be less than the fair market value of a share of Common Stock on the date the stock appreciation
right is granted. This award is intended to mirror the benefit the participant would have received if the compensation committee had granted
the participant an option. The maximum term of a stock appreciation right shall be determined by the compensation committee on the date
of grant but shall not exceed 10 years. Distributions with respect to stock appreciation rights may be made in cash, shares of Common
Stock, or a combination of both, at the board of director's discretion.

 Unless otherwise provided in an award agreement
or determined by the compensation committee, if a participant terminates employment with us (or our affiliates) for any reason other
than cause, the participant may exercise his or her unexercised options and stock appreciation rights, to the extent they were exercisable
on the termination date, within the following period of time, provided however that in no event may any award be exercised after termination
of its maximum term: (i) three months following the date of such termination if such termination is a termination without cause (other
than any termination due to the participant's disability or death); (ii) 12 months following the date of such termination if such
termination is due to the participant's disability; (iii) 18 months following the date of such termination if such termination
is due to the participant's death; or (iv) 18 months following the date of the participant's death if such death occurs following
the date of such termination but during the period such Award is otherwise exercisable. If the participant terminates employment with
us (or our affiliates) for cause, all unexercised options and stock appreciation rights (whether vested or unvested) shall terminate
and be forfeited on the termination date. Unless otherwise provided by the compensation committee, any options and stock appreciation
rights that are not exercisable at the time of termination of employment shall terminate and be forfeited on the termination date.

 Restricted Stock. A restricted stock award
is a grant of shares of Common Stock, which are subject to forfeiture restrictions during a restriction period. The compensation committee
will determine the price, if any, to be paid by the participant for each share of Common Stock subject to a restricted stock award. The
restricted stock may be subject to Vesting Conditions. If the specified Vesting Conditions are not attained, the participant will forfeit
the portion of the restricted stock award with respect to which those conditions are not attained, and the underlying Common Stock will
be forfeited to us. At the end of the restriction period, if the Vesting Conditions have been satisfied, the restrictions imposed will
lapse with respect to the applicable number of shares. Unless otherwise provided in an award agreement or determined by the compensation
committee, upon termination a participant will forfeit all restricted stock that then remains subject to forfeiture restrictions.

 Restricted Stock Units. Restricted stock
units are granted in reference to a specified number of shares of Common Stock and entitle the holder to receive, on the achievement of
applicable Vesting Conditions, shares of Common Stock. Unless otherwise provided in an award agreement or determined by the compensation
committee, upon termination a participant will forfeit all restricted stock units that then remain subject to forfeiture.

 Change of Control

 In the event of a change of control, unless otherwise
provided in a grant agreement, employment agreement or other agreement between the Company and the participant, and unless otherwise
determined by an affirmative vote of a majority of the board of directors prior to the occurrence of such change of control: (i) the
vesting and settlement of all outstanding awards to non-employee directors will be automatically accelerated and the shares immediately
issued to the participant (or the Board may direct the payment of a cash settlement equal to the fair market value of the shares that
would otherwise be issued to the participant); (ii) the settlement of vested awards to employees and consultants will automatically be
accelerated and the shares immediately issued to the participant; and (iii) unvested awards to employees and consultants shall be terminated
and forfeited unless the acquiring entity assumes, continues or substitutes any such awards. Notwithstanding the foregoing, to the extent
permitted and in compliance with the requirements of Section 409A of the Code, the Board may in its discretion determine to elect to
accelerate the vesting and settlement of the unvested awards to employees and consultants upon a Change of Control, or direct the payment
of a cash settlement equal to the fair market value of the shares that would otherwise be issued to the participant).

 Repricing

 Neither our board of directors nor the compensation
committee may reduce the exercise price in effect for outstanding options under the 2022 Plan without obtaining the consent of any participant
whose award would be materially impaired by such action.

 Miscellaneous

 Generally, awards granted under the 2022 Plan
shall be nontransferable except by will or by the laws of descent and distribution. No participant shall have any rights as a stockholder
with respect to shares covered by options or restricted stock units, unless and until such awards are settled in shares of Common Stock.
Our obligation to issue shares or to otherwise make payments in respect of 2022 Plan awards will be conditioned on our ability to do so
in compliance with all applicable laws and exchange listing requirements. The awards will be subject to our recoupment and stock ownership
policies, as may be in effect from time to time. The 2022 Plan expires 10 years after it becomes effective.

 2022 Initial Equity Incentive Plan

 We adopted the Initial Plan on July 11, 2022,
which was later amended and restated on October 16, 2022, for purposes of clarifying the application of certain of the rules of the Initial
Plan to awards approved before such amendment and restatement of the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics,
Inc. 2022 Successor Equity Incentive Plan (the "Successor Plan") for the issuance and approval of awards. The principal provisions
of the Initial Plan are summarized below. On October 16, 2022, the Board adopted, and our stockholders approved, the Cadrenal Therapeutics,
Inc. 2022 Plan, as a successor to and continuation of the Initial Plan, which became effective on January 19, 2023. The 2022 Plan replaced
the Initial Plan, except with respect to awards outstanding under the Initial Plan, and no further awards will be available for grant
under the Initial Plan.

 Clawback Policy

 The Board has adopted a clawback policy which
allows us to recover performance-based compensation, whether cash or equity, from a current or former executive officer in the event
of an Accounting Restatement. The clawback policy defines an Accounting Restatement as an accounting restatement of our financial statements
due to our material noncompliance with any financial reporting requirement under the securities laws. Under such policy, we may recoup
incentive-based compensation previously received by an executive officer that exceeds the amount of incentive-based compensation that
otherwise would have been received had it been determined based on the restated amounts in the Accounting Restatement.

 The Board has the sole discretion to determine the form and timing
of the recovery, which may include repayment, forfeiture and/or an adjustment to future performance-based compensation payouts or awards.
The remedies under the clawback policy are in addition to, and not in lieu of, any legal and equitable claims available to the Company.
The clawback policy is incorporated by reference in this Annual Report as an exhibit.

 Equity Compensation Policy and Practices

 While we do not have a formal written policy in
place with regard to the timing of awards of options in relation to the disclosure of material nonpublic information, the Compensation
Committee does not seek to time equity grants to take advantage of information, either positive or negative, about our company that has
not been publicly disclosed. It has been our practice to grant equity awards to our officers and directors upon their appointment. We
intend to issue equity grants to our officers and/or directors at the same time each year, in connection with our first meeting of the
Board of Directors each fiscal year. Option grants are effective on the date the award determination is made by the Compensation Committee,
and the exercise price of options is the closing market price of our Common Stock on the business day of the grant or, if the grant
is made on a weekend or holiday, on the prior business day.

 During the fiscal year ended December 31, 2024,
we did not award any options to a named executive officer in the period beginning four business days before the filing of a periodic report
on Form 10-Q or Form 10-K, or the filing or furnishing of a current report on Form 8-K that discloses material nonpublic information,
and ending one business day after the filing or furnishing of such report.

 Director Compensation

 The following table shows certain information with respect to the compensation
of all of our non-employee directors for the fiscal year ended December 31, 2024:

 Name

 Fees Earned or
 Paid in Cash
 ($)

 Stock
 Awards
 ($)(1)(2)

 Option
 Awards
 ($)(1)(2)

 Total
 ($)

 $
 60,000

 $
 -

 $
 63,303

 $
 123,303

 Steven Zelenkofske, D.O.

 $
 45,000

 $
 -

 $
 63,303

 $
 108,303

 Glynn Wilson, Ph. D.

 $
 45,000

 $
 -

 $
 44,313

 $
 89,313

 $
 35,000

 $
 -

 $
 31,647

 $
 66,647

 (1)

 In accordance with SEC
 rules, this column reflects the aggregate fair value of the stock and option awards granted as of their respective grant dates in
 accordance with Financial Accounting Standard Board Accounting Standards Codification Topic 718 for stock-based compensation transactions
 (ASC 718). The valuation assumptions used in determining such amounts are described in Note 1 and Note 10 to our audited financial
 statements included elsewhere in this Annual Report. These amounts do not correspond to the actual value that may be realized by
 the Directors upon vesting or exercise of such awards.

 For the fiscal year ended December 31, 2024, our directors received
annual cash compensation in the amount of $35,000 and the Chair of the Audit Committee received an additional annual cash compensation
of $25,000 per year and the Chair of the Compensation Committee and Nominating and Corporate Governance Committee each received additional
annual cash compensation of $10,000 per year. From time to time, we may grant additional stock options to certain of our non-employee
directors as compensation for their services as directors.

 (2)

 The table below shows the
 aggregate number of option awards outstanding at fiscal year-end of our non-employee directors.

 Name

 Shares
 Subject to
 Options as of
 2024

 13,334

 Steven Zelenkofske, D.O.

 10,000

 Glynn Wilson, Ph. D.

 8,000

 8,333

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

 The following table sets forth the beneficial
ownership of our Common Stock as of March 13, 2025, by:

 each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our Common Stock;

 each
of the named executive officers;

 each
of our directors and director; and

 all
of our current executive officers and directors as a group

 As of March 13, 2025, we had 1,879,710 shares
of Common Stock outstanding, held by approximately 20 stockholders of record. This number does not include stockholders for whom shares
are held in a "nominee" or "street" name.

 We have determined beneficial ownership in accordance
with the rules of the SEC, and thus it represents sole or shared voting or investment power with respect to our securities. Unless otherwise
indicated below, to our knowledge, the persons and entities named in the table have sole voting and sole investment power with respect
to all shares that they beneficially owned, subject to community property laws where applicable. The information does not necessarily
indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Exchange Act.

 We have based our calculation of the percentage
of beneficial ownership on 1,879,710 shares of our Common Stock outstanding as of March 13, 2025. We have deemed shares of our Common
Stock subject to securities that are currently convertible or exercisable into shares of Common Stock, or convertible or exercisable into
shares of our Common Stock within 60 days of March 13, 2025, to be outstanding and to be beneficially owned by the person holding the
stock option for the purpose of computing the percentage ownership of that person. We did not deem these shares outstanding, however,
for the purpose of computing the percentage ownership of any other person. Unless otherwise indicated, the address of each beneficial
owner listed in the table below is c/o Cadrenal Therapeutics, Inc., 822 A1A North, Suite 306, Ponte Vedra, Florida 32082.

 Name of Beneficial Owner

 Shares
 Beneficially
 Owned

 Percentage

 Named Executive Officers and Directors

 421,250
 (1)

 22.38
 %

 38,194
 (2)

 2.03
 %

 8,750
 (3)

 *

 John Murphy

 53,575
 (4)

 2.83
 %

 Steven Zelenkofske

 12,304
 (5)

 *

 Glynn Wilson

 10,692
 (6)

 *

 6,112
 (7)

 *

 All current executive officers and directors as a group (8 persons)

 550,877

 28.51
 %

 5% Stockholders other than executive officers and directors

 The PVBQ Living Trust

 200,000
 (1)

 10.64
 %

 *
 Represents
beneficial ownership of less than one percent.

 (1)
 Includes (i) 218,333 shares of Common Stock owned by Quang X. Pham;
(ii) 200,000 shares of Common Stock owned by The PVBQ Living Trust; and (iii) 2,917 shares of Common Stock issuable upon the exercise
of options held by Mr. Pham that are exercisable within the 60-day period following March 13, 2025. The beneficiary of The PVBQ Living
Trust (the "Trust") is Mr. Pham's child and Mr. Pham is the trustee of the Trust and has sole voting and disposition
power with respect to the shares owned by the Trust. The address for the Trust is 822 A1A North, Suite 306, Ponte Vedra, Florida 32082.

 (2)

 Includes (i) 33,333 shares of Common Stock; and (ii) 4,861 shares of Common Stock issuable upon the exercise of options held by Mr. Szot that are exercisable within the 60-day period following March 13, 2025.

 (3)

 Includes 8,750 shares of Common Stock issuable upon the exercise of options held by Mr. Cole that are exercisable within the 60-day period following March 13, 2025.

 (4)

 Includes: (i) 40,986 shares of Common Stock; and (ii) 12,589 shares of Common Stock issuable upon the exercise of options held by Mr. Murphy that are exercisable within the 60-day period following March 13, 2025.

 (5)

 Includes: (i) 2,666 shares of Common Stock; and (ii) 9,638 shares of Common Stock issuable upon the exercise of options held by Dr. Zelenkofske that are exercisable within the 60-day period following March 13, 2025.

 (6)

 Includes (i) 3,333 shares of Common Stock; and (ii) 7,359 shares of Common Stock issuable upon the exercise of options held Dr. Wilson that are exercisable within the 60-day period following March 13, 2025.

 (7)

 Includes 6,112 shares of Common Stock issuable upon the exercise of options held by Mr. Lisicki that are exercisable within the 60-day period following March 13, 2025.

 Changes In Control

 None.

 Equity Compensation Plan Information

 See Part II, Item 5— "Equity Compensation
Plan Information" for certain information regarding our equity compensation plans.

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

 Each of the related party transactions described
below was negotiated on an arm's length basis. We believe that the terms of such agreements are as favorable as those we could
have obtained from parties not related to us. The following are summaries of certain provisions of our related party agreements and are
qualified in their entirety by reference to all of the provisions of such agreements. Because these descriptions are only summaries of
the applicable agreements, they do not necessarily contain all of the information that you may find useful. We therefore urge you to
review the agreements in their entirety. Copies of the forms of the agreements have been filed as exhibits to the Registration Statement
and are available electronically on the website of the SEC at www.sec.gov.

 Other than the compensation arrangements, including employment, termination
of employment and change in control arrangements, with our directors and executive officers, including those discussed in the sections
titled "Management" and "Executive Compensation," we have not engaged in any transaction since January 1, 2023
and are not currently engaged in any transaction in which:

 we have been or are to
 be a party to;

 the amount involved exceeded
 or exceeds $120,000 or 1% of the average of our total assets as of the end of the last two completed fiscal years; and

 any of our directors, executive
 officers or holders of more than 5% of our outstanding capital stock, or any immediate family member of, or person sharing the household
 with, any of these individuals or entities, had or will have a direct or indirect material interest.

 For information on our compensation arrangements,
including employment, termination of employment and change in control arrangements, with our directors and executive officers, see the
sections titled "Management" and "Executive Compensation."

 Indemnification Agreements

 We have entered into separate indemnification
agreements with each of our current executive officers and intend to enter into separate indemnification agreements with each of our
directors and executive officers, in addition to the indemnification that will be provided for in our amended and restated bylaws. The
indemnification agreements and our amended restated bylaws require us to indemnify our directors and executive officers to the fullest
extent permitted by Delaware law. See the section titled "Description of Securities — Limitations on Liability and Indemnification
of Officers and Directors" for additional information.

 Our Policy Regarding Related Party Transactions

 Our board of directors recognizes the fact that
transactions with related persons present a heightened risk of conflicts of interest and/or improper valuation (or the perception thereof).
Our board of directors adopted a written policy on transactions with related persons that is in conformity with the requirements for
issuers having publicly held common stock that is listed on the Nasdaq Stock Market. Under the new policy:

 any related person transaction,
 and any material amendment or modification to a related person transaction, must be reviewed and approved or ratified by the Audit
 Committee; and

 any employment relationship
 or transaction involving an executive officer and any related compensation must be approved by the compensation committee of the
 board of directors or recommended by the compensation committee to the board of directors for its approval.

 In connection with the review and approval or
ratification of a related person transaction:

 management must disclose to the committee or disinterested directors, as applicable, the name of the related person and the basis on which the person is a related person, the material terms of the related person transaction, including the approximate dollar value of the amount involved in the transaction, and all the material facts as to the related person's direct or indirect interest in, or relationship to, the related person transaction;

 management must advise the committee or disinterested directors, as applicable, as to whether the related person transaction complies with the terms of our agreements governing our material outstanding indebtedness that limit or restrict our ability to enter into a related person transaction;

 management must advise the committee or disinterested directors, as applicable, as to whether the related person transaction will be required to be disclosed in our applicable filings under the Securities Act or the Exchange Act, and related rules, and, to the extent required to be disclosed, management must ensure that the related person transaction is disclosed in accordance with the Securities Act and the Exchange Act and related rules; and

 management must advise the committee or disinterested directors, as applicable, as to whether the related person transaction constitutes a "personal loan" for purposes of Section 402 of the Sarbanes-Oxley Act.

 In addition, the related person transaction policy
provides that the committee or disinterested directors, as applicable, in connection with any approval or ratification of a related person
transaction involving a non-employee director, should consider whether such transaction would compromise the director's status as
an "independent," "outside," or "non-employee" director, as applicable, under the rules and regulations
of the SEC, the Nasdaq Stock Market, and the Code.

 Director Independence

 The information included under the heading "Directors,
Executive Officers and Corporate Governance—Director Independence" in Part III, Item 10 is hereby incorporated by reference
into this Item 13.

 Item 14. Principal Accounting Fees and Services.

 WithumSmith+Brown, P.C. serves as our independent registered public
accounting firm.

 Independent Registered Public Accounting Firm Fees and Services

 The following table sets forth the aggregate fees
including expenses billed to us for the years ended December 31, 2024 and 2023 by our auditors:

 2024

 2023

 Audit Fees

 $
 185,007

 $
 112,300

 Tax Fees

 -

 -

 Audit-Related Fees

 29,930

 37,901

 All Other Fees

 -

 -

 Total

 $
 214,937

 $
 150,201

 ***

 Audit-related fees represent charges for work on registration statements including comfort letters and consents.

 The Audit Committee has adopted procedures for
pre-approving all audit and non-audit services provided by the independent registered public accounting firm, including the fees and terms
of such services. These procedures include reviewing detailed back-up documentation for audit and permitted non-audit services. The documentation
includes a description of, and a budgeted amount for, particular categories of non-audit services that are recurring in nature and therefore
anticipated at the time that the budget is submitted. Audit Committee approval is required to exceed the pre-approved amount for a particular
category of non-audit services and to engage the independent registered public accounting firm for any non-audit services not included
in those pre-approved amounts. For both types of pre-approval, the Audit Committee considers whether such services are consistent with
the rules on auditor independence promulgated by the SEC and the PCAOB. The Audit Committee also considers whether the independent registered
public accounting firm is best positioned to provide the most effective and efficient service, based on such reasons as the auditor's
familiarity with our business, people, culture, accounting systems, risk profile, and whether the services enhance our ability to manage
or control risks, and improve audit quality. The Audit Committee may form and delegate pre-approval authority to subcommittees consisting
of one or more members of the Audit Committee, and such subcommittees must report any pre-approval decisions to the Audit Committee at
its next scheduled meeting. All of the services provided by the independent registered public accounting firm were pre-approved by the
Audit Committee.

 Item 15. Exhibits and Financial Statement Schedules.

 (a)(1)

 Financial Statements. The financial statements required to be filed in this Annual Report are included in Part II, Item 8 hereof.

 (a)(2)

 All financial statement schedules have been omitted as the required information is either inapplicable or included in the Financial Statements or related notes included in Part II, Item 8 hereof.

 (a)(3)

 Exhibits. The exhibits listed below are required by Item 601 of Regulation S-K. Each management contract or compensatory plan or arrangement required to be filed as an exhibit to this Annual Report has been identified

 Item 16. Form 10-K Summary.

 Not Applicable.

 Exhibit No.

 Description

 3.1

 Amended and Restated Certificate of Incorporation (Incorporated by reference as Exhibit 3.3 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 3.2

 Amended and Restated Bylaws (Incorporated by reference as Exhibit 3.2 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022)

 3.3

 Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Cadrenal Therapeutics, Inc. (Incorporated by reference as Exhibit 3.1 to the Current Report on Form 8-K filed on August 20, 2024)

 4.1

 Specimen Common Stock Certificate (Incorporated by reference as Exhibit 4.1 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 4.2#

 Convertible Promissory Note dated March 1, 2022 issued to John Murphy (Incorporated by reference as Exhibit 4.3 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 4.3

 Form of Convertible Note dated June 13, 2022 (Incorporated by reference as Exhibit 4.4 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 4.4

 Form of Private Placement Convertible Note (Incorporated by reference as Exhibit 4.5 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 4.5

 Form of November Private Placement Promissory Note (Incorporated by reference as Exhibit 4.6 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022)

 4.6

 Form of Amended and Restated November Warrant (Incorporated by reference as Exhibit 4.7 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022)

 4.7

 Form of Amended and Restated Placement Agent Warrant from Private Placement (Incorporated by reference as Exhibit 4.8 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022)

 4.8

 Form of Placement Agent Warrant from November Private Placement (Incorporated by reference as Exhibit 4.9 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022)

 4.9

 Form of Amendment to Convertible Promissory Note (Incorporated by reference as Exhibit 4.10 to the Registration Statement on Form S-1 (333-267562) filed on December 6, 2022)

 4.10

 Representative's Warrant issued to Boustead Securities, LLC dated January 19, 2023 (Incorporated by reference as Exhibit 4.1 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023)

 4.11

 Description of Securities (Incorporated by reference as Exhibit 4.11 to the Annual Report on Form 10-K (001-41596) filed with the SEC on March 30, 2023)

 4.12

 Form of Pre-Funded Warrant (Incorporated by reference as Exhibit 4.1 to the Current Report on Form 8-K 001-41596), as filed with the SEC on July 14, 2023)

 4.13

 Form of Warrant (Incorporated by reference as Exhibit 4.2 to the Current Report on Form 8-K 001-41596), as filed with the SEC on July 14, 2023)

 4.14

 Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.3 to the Current Report on Form 8-K 001-41596), as filed with the SEC on July 14, 2023)

 4.15

 Form of New Warrant (Incorporated by reference as Exhibit 4.1 to the Current Report on Form 8-K filed on November 4, 2024)

 4.16

 Form of Placement Agent Warrant (Incorporated by reference as Exhibit 4.2 to the Current Report on Form 8-K filed on November 4, 2024)

 10.1#

 Cadrenal Therapeutics, Inc. 2022 Equity Incentive Plan and form of Incentive Stock Option Agreement, Non-Qualified Stock Option Agreement for Officers and Other Employees, Non-Qualified Stock Option Agreement for Directors and Consultants, Restricted Stock Agreement, and Restricted Stock Unit Agreement (Incorporated by reference as Exhibit 10.1 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.2#

 Consulting Agreement, dated January 25, 2022, with Phamace LLC (Quang Pham) from company formation until initiation of payroll (Incorporated by reference as Exhibit 10.2 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.3#

 Employment Agreement, dated March 1, 2022 with Quang Pham (Incorporated by reference as Exhibit 10.3 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.4#

 Restricted Stock Purchase Agreement with Matthew Szot (Incorporated by reference as Exhibit 10.5 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.5

 Asset Purchase Agreement dated as of April 1, 2022, between Cadrenal Therapeutics, Inc. and HESP LLC (Incorporated by reference as Exhibit 10.7 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.6

 Patent Assignment Agreement dated as of April 1, 2022, between Cadrenal Therapeutics, Inc. and HESP LLC (Incorporated by reference as Exhibit 10.8 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.7

 Subscription Agreement with Quang Pham, dated January 25, 2022 (Incorporated by reference as Exhibit 10.9 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.8

 Form of Investor Rights and Lockup Agreement (Incorporated by reference as Exhibit 10.10 to the Registration Statement on Form S-1 (333-267562) filed on September 22, 2022)

 10.9+

 License, Development and Commercialization Agreement Effective as of September 16, 2015 by and between Armetheon, Inc. and China Cardiovascular Focus Ltd. (Incorporated by reference as Exhibit 10.13 to the Registration Statement on Form S-1 (333-267562) filed on October 11, 2022)

 10.10#

 Cadrenal Therapeutics, Inc. 2022 Amended and Restated Equity Incentive Plan (Incorporated by reference as Exhibit 10.14 to the Registration Statement on Form S-1 (333-267562) filed on October 17, 2022)

 10.11#

 Form of Stock Option Grant Notice, Stock Option Agreement and Notice of Exercise under the 2022 Amended and Restated Equity Incentive Plan (Incorporated by reference as Exhibit 10.15 to the Registration Statement on Form S-1 (333-267562) filed on October 17, 2022)

 10.12#

 Form of Indemnification Agreement (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023)

 10.13

 Amendment to Asset Purchase Agreement, dated as of August 18, 2022, between Cadrenal Therapeutics, Inc. and HESP LLC (Incorporated by reference as Exhibit 10.2 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023)

 10.14#

 Employment Agreement with Matthew Szot (Incorporated by reference as Exhibit 10.3 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023)

 10.15#

 Employment Agreement with Douglas Losordo (Incorporated by reference as Exhibit 10.4 to the Current Report on Form 8-K (001-41596) filed with the SEC on January 25, 2023)

 10.16#

 Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (Incorporated by reference as Exhibit 10.16 to the Registrant's Registration Statement on Form S-1 (File No. 333-267562) filed with the SEC on January 17, 2023)

 10.17#

 Form of Stock Option Grant Notice, Stock Option Agreement and Notice of Exercise under the 2022 Successor Equity Incentive Plan (Incorporated by reference as Exhibit 10.17 to the Registrant's Registration Statement on Form S-1 (File No. 333-267562) filed with the SEC on January 17, 2023)

 10.18#

 Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the 2022 Successor Equity Incentive Plan (Incorporated by reference as Exhibit 10.18 to the Registrant's Registration Statement on Form S-1 (File No. 333-267562) filed with the SEC on January 17, 2023)

 10.19#

 Amendment No. 1 to Employment Agreement by and between Cadrenal Therapeutics, Inc. and Matthew Szot, dated May 25, 2023 (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K (001-41596) filed with the SEC on May 26, 2023)

 10.20

 Form of Securities Purchase Agreement (Incorporated herein by reference to Exhibit 10.1 of the Registrant's Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023)

 10.21

 Form of Registration Rights Agreement (Incorporated herein by reference to Exhibit 10.2 of the Registrant's Current Report on Form 8-K (001-41596), as filed with the SEC on July 14, 2023)

 10.22#

 Offer Letter dated, February 6, 2024, between Cadrenal Therapeutics, Inc. and Jeffrey Cole (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K filed on February 12, 2024)

 10.23#

 Employment Agreement, effective as of February 8, 2024, between Cadrenal Therapeutics, Inc. and Jeffrey Cole (Incorporated by reference as Exhibit 10.2 to the Current Report on Form 8-K filed on February 12, 2024)

 10.24#

 Amendment to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K filed on July 31, 2024)

 10.25

 Form of Warrant Inducement Agreement (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K filed on November 4, 2024)

 10.26#

 Employment Agreement between Cadrenal Therapeutics, Inc. and James J. Ferguson III, effective February 5, 2025 (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K filed on February 7, 2025)

 10.27#

 Severance and Release Letter Agreement, dated February 7, 2025, between Cadrenal Therapeutics, Inc. and Douglas Losordo (Incorporated by reference as Exhibit 10.2 to the Current Report on Form 8-K filed on February 7, 2025)

 10.28

 Collaboration Agreement between Abbott Global Enterprises Limited and Cadrenal Therapeutics, Inc. (Incorporated by reference as Exhibit 10.1 to the Current Report on Form 8-K filed on March 4, 2025)

 19.1*

 Amended and Restated Insider Trading Policy

 21.1

 Subsidiaries of Registrant (Incorporated by reference as Exhibit 21.1 to the Annual Report on Form 10-K filed on March 11, 2024)

 23.1*

 Consent of Independent Registered Public Accounting Firm

 31.1*

 Certification of the Principal Executive Officer Pursuant to Rule 13a-14 and 15d-14 of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 31.2*

 Certification of the Principal Financial Officer and Principal Accounting Officer Pursuant to Rule 13a-14 and 15d-14 of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 32.1*

 Certification by the Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 32.2*

 Certification by the Principal Financial Officer and Principal Accounting Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 97.1

 Clawback Policy (Incorporated by reference as Exhibit 97.1 to the Annual Report on Form 10-K filed on March 11, 2024)

 101.INS

 101.SCH

 101.CAL

 101.DEF

 101.LAB

 101.PRE

 *

 Filed herewith.

 #

 Management contract or compensatory plan or arrangement required to be identified pursuant to Item 15(a)(3) of this Annual Report.

 +

 Certain portions of this exhibit indicated therein by [***] have been omitted in accordance with Item 601(b)(10) of Regulation S-K.

 SIGNATURES

 Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized
on the 13th day of March, 2025.

 Cadrenal Therapeutics, Inc.

 (Registrant)

 Dated: March 13, 2025

 /s/ Quang X. Pham

 Chairman of the Board and Chief Executive Officer

 KNOW ALL PERSONS BY THESE PRESENTS, that each
person whose signature appears below constitutes and appoints Quang Pham, his true and lawful attorney-in-fact and agent, with full power
of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments
to this report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and
Exchange Commission, granting unto said attorneys-in-fact and agents, full power and authority to do and perform each and every act and
thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person,
hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitutes or substitute, may lawfully do or cause to
be done by virtue hereof.

 Pursuant to the requirements of the Securities
Exchange Act of 1934, this Annual Report has been signed below by the following persons on behalf of the registrant, Cadrenal Therapeutics,
Inc., in the capacities and on the date indicated.

 Signature

 Title

 Date

 /s/

 Chairman of the Board and Chief Executive Officer

 Quang X.
 Pham

 (Principal Executive Officer)

 /s/ Matthew Szot

 Chief Financial Officer (Principal Financial Officer

 and Principal Accounting Officer)

 /s/ John R. Murphy

 /s/ Glynn Wilson

 Glynn Wilson

 /s/ Steven Zelenkofske

 Steven Zelenkofske

 /s/ Robert Lisicki

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