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

☐ 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

CADRENAL THERAPEUTICS, INC.

(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 ☒

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

Yes ☒ No ☐

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

Yes ☒ No ☐

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

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

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

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

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

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). ☐

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

The aggregate market value of the voting and non-voting common equity held by non-affiliates 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

CADRENAL THERAPEUTICS, INC.

		Page
PART I

Item 1.	Business	4
Item 1A.	Risk Factors	30
Item 1B.	Unresolved Staff Comments	71
Item 1C.	Cybersecurity	71
Item 2.	Properties	71
Item 3.	Legal Proceedings	71
Item 4.	Mine Safety Disclosures	71

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	72
Item 6.	[Reserved]	73
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	73
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	76
Item 8.	Financial Statements and Supplementary Data	F-1
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	77
Item 9A.	Controls and Procedures	77
Item 9B.	Other Information	78
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	78

PART III

Item 10.	Directors, Executive Officers and Corporate Governance	79
Item 11.	Executive Compensation	87
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	96
Item 13.	Certain Relationships and Related Transactions, and Director Independence	97
Item 14.	Principal Accountant Fees and Services	99

PART IV

Item 15.	Exhibits and Financial Statement Schedules	100
Item 16.	Form 10-K Summary	100

PART 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 co

SEC Form 10-K filed by Cadrenal Therapeutics Inc.