8-K
Cadrenal Therapeutics, Inc. (CVKD)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934
Date of Report (date of earliest event reported): May 8, 2025
Cadrenal Therapeutics, Inc.
(Exact name of registrant as specified in charter)
| Delaware | 001-41596 | 88-0860746 |
|---|---|---|
| (State or other jurisdictionof incorporation) | (Commission File Number) | (IRS EmployerIdentification No.) |
822 A1A North, Suite 306
Ponte Vedra, Florida 32082
(Address of principal executive offices and zip code)
(904) 300-0701
(Registrant’s telephone number including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities<br>Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12(b) under the<br>Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b)<br>under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c)<br>under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbols | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | CVKD | The Nasdaq Stock Market LLC(Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by checkmark 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. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 8, 2025, Cadrenal Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release that included financial information for the fiscal quarter ended March 31, 2025. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are furnished with this Current Report on Form 8-K:
| Exhibit Number | Exhibit Description |
|---|---|
| 99.1 | Press Release, issued by Cadrenal Therapeutics, Inc. on May 8, 2025 |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within in the inline XBRL<br> document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: May 8, 2025 | CADRENAL THERAPEUTICS, INC. | |
|---|---|---|
| By: | /s/ Quang X. Pham | |
| Name: | Quang X. Pham | |
| Title: | Chairman and Chief Executive Officer |
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Exhibit 99.1
Cadrenal TherapeuticsReports First-Quarter 2025 FinancialResults and Provides Corporate Update
Leadership appointmentstrengthens strategic and development capabilities.
FDA Type D Meeting provides additional guidancefor advancing the clinical development of tecarfarin
Collaboration Agreement with Abbott (NYSE:ABT) validates the need for new anticoagulation options
PONTE VEDRA, Fla., May8, 2025 -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today reported its financial results for the first quarter ended March 31, 2025, and provided an update on the strategic focus of the company and clinical development of tecarfarin.
“In the first quarter of 2025, Cadrenal continued to build on the momentum we achieved during 2024,” said Quang X. Pham, Chairman & CEO. “The appointment of James Ferguson, M.D., FACC, FAHA, as our Chief Medical Officer we believe positions us for success in reviewing potential assets to add to our portfolio and designing and executing our clinical program for tecarfarin. The finalized Collaboration Agreement with Abbott validates the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs). And our meeting with the FDA provided additional guidance in the design of a pivotal trial.”
Highlights from the Quarter Ended March 31,2025, and Other Recent Events:
Leadership Advances
In February 2025, Cadrenal appointed James J. Ferguson, M.D., FACC, FAHA, as Chief Medical Officer to lead the review of business development opportunities to expand the Company’s pipeline and drive the late-stage clinical development of tecarfarin for conditions requiring chronic anticoagulation therapy.
Regulatory Update
In February 2025, Cadrenal met with the U.S. Food and Drug Administration (FDA) for a Type D meeting. The FDA provided additional guidance on the appropriate design for a Phase 3 tecarfarin trial and welcomed submission of a final study design for review.
Collaboration Agreement with Abbott
In March 2025, we announced a Collaboration Agreement with Abbott (NYSE: ABT) to support our pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Under the agreement, Abbott will share insights from recent HeartMate 3™ clinical trials and will support Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise.
Operational Milestones
During the quarter, Cadrenal successfully completed the technical transfer and manufacturing of its tecarfarin drug substance (API) from a CDMO site located in Asia to a CDMO site in the United States. This initiative was done to support the company’s clinical and regulatory development strategy for tecarfarin and to improve supply chain security.
Cadrenal also conducted strategic market opportunity research for multiple indications, including patients with left ventricular assist devices. This research indicates that tecarfarin is uniquely positioned to provide clinical value to patients in the rapidly growing LVAD market, which is projected to nearly double by 2032. This research also showed that tecarfarin has the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients.
Participation in Key Investor, Medical, andBusiness Development Conferences
Cadrenal was active during the first quarter in several significant conferences to build corporate visibility and underscore its commitment to advancing innovation in anticoagulation therapy. Investor interactions included participation at the 43^rd^ Annual J.P. Morgan Healthcare Conference in San Francisco, a Company presentation at the BIO CEO and Investor Conference in New York, and, after the close of the quarter, a Company presentation at the Centri Capital Conference at Nasdaq headquarters in New York. Shortly after the quarter’s close, Cadrenal participated in the 18^th^ National Conference on Anticoagulation Therapy in Washington, D.C.
Strategic Development Collaborations
Cadrenal continues to explore opportunities to add to the Company’s clinical pipeline and collaborate with potential development partners to advance the development of tecarfarin for patients with LVADs and for other indications requiring chronic anticoagulation.
First Quarter 2025 Financial Highlights
Research and development expenses for the quarter ended March 31, 2025, were $1.7 million compared to $0.6 million for the same period in 2024. General and administrative expenses for the quarter ended March 31, 2025, were $2.3 million compared to $1.1 million for the same period in 2024. Cadrenal reported a net loss of $3.8 million for the quarter ending March 31, 2025, compared to $1.7 million for the same period in 2024.
On March 31, 2025, Cadrenal had cash and cash equivalents of $7.3 million, compared to $10.0 million as of December 31, 2024. The Company had approximately 1.9 million shares of common stock outstanding as of March 31, 2025.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options.
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Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).
Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/ and connect with us on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the The the appointment of James Ferguson, M.D., FACC, FAHA, as the Company’s Chief Medical Officer positioning the Company for success in reviewing potential assets to add to its portfolio and designing and executing its clinical program for tecarfarin; the finalized Collaboration Agreement with Abbott validating the critical need in the market for a new anticoagulant for patients with left ventricular assist devices (LVADs); Abbott sharing insights from recent HeartMate 3™ clinical trials and supporting Cadrenal with trial design, site identification, trial awareness, and HeartMate 3™ expertise; the LVAD market projected to nearly double by 2032; and tecarfarin having the potential to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to utilize Abbott’s expertise to advance tecarfarin, the ability to successfully collaborate with Abbott, the initiation of the pivotal clinical trial for tecarfarin in LVAD patients by Cadrenal; for tecarfarin to provide clinical benefit in additional high-need cardiovascular, renal, and mechanical heart valve indications, reinforcing tecarfarin’s potential value proposition for patients; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
(Tables to Follow)
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CADRENAL THERAPEUTICS, INC.
BALANCE SHEETS
| December 31, | |||||
| 2024 | |||||
| Assets: | |||||
| Current assets: | |||||
| Cash and cash equivalents | 7,336,072 | $ | 10,017,942 | ||
| Interest receivable | 24,664 | 38,153 | |||
| Prepaid expenses and other current assets | 575,605 | 42,257 | |||
| Deferred offering costs | 8,451 | 14,445 | |||
| Total current assets | 7,944,792 | 10,112,797 | |||
| Property, plant and equipment, net | 4,678 | 6,944 | |||
| Other assets | 3,792 | 3,792 | |||
| Total assets | 7,953,262 | $ | 10,123,533 | ||
| Liabilities and Stockholders' Equity: | |||||
| Current liabilities: | |||||
| Accounts payable | 1,278,402 | $ | 1,502,468 | ||
| Accrued liabilities | 561,764 | 1,181,490 | |||
| Total current liabilities | 1,840,166 | 2,683,958 | |||
| Total liabilities | 1,840,166 | 2,683,958 | |||
| Stockholders’ equity: | |||||
| Preferred stock, 0.001 par value, 7,500,000 shares authorized, no shares issued and outstanding at March 31, 2025 and December 31, 2024 | - | - | |||
| Common stock, 0.001 par value; 75,000,000 shares authorized, 1,909,732 shares issued and outstanding as of March 31, 2025; 1,782,486 shares issued and outstanding as of December 31, 2024 | 1,909 | 1,782 | |||
| Additional paid-in capital | 35,679,350 | 33,160,576 | |||
| Accumulated deficit | (29,568,163 | ) | (25,722,783 | ) | |
| Total stockholders’ equity | 6,113,096 | 7,439,575 | |||
| Total liabilities and stockholders’ equity | 7,953,262 | $ | 10,123,533 |
All values are in US Dollars.
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CADRENAL THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVELOSS
| Three Months Ended <br> March 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | |||||
| Operating expenses: | ||||||
| General and administrative expenses | $ | 2,254,577 | $ | 1,125,993 | ||
| Research and development expenses | 1,667,882 | 629,025 | ||||
| Depreciation expense | 5,517 | 597 | ||||
| Total operating expenses | 3,927,976 | 1,755,615 | ||||
| Loss from operations | (3,927,976 | ) | (1,755,615 | ) | ||
| Other income | ||||||
| Interest and dividend income | 82,596 | 92,327 | ||||
| Total other income | 82,596 | 92,327 | ||||
| Net loss and comprehensive loss | $ | (3,845,380 | ) | $ | (1,663,288 | ) |
| Net loss per common share, basic and diluted (1) | $ | (2.09 | ) | $ | (1.56 | ) |
| Weighted average number of common shares used in computing net loss per common share, basic and diluted (1) | 1,844,072 | 1,067,231 | ||||
| (1) | All share and per share information has been retroactively<br> adjusted to reflect the 1-for-15 reverse stock split effected on August 20, 2024. | |||||
| --- | --- |
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CONTACTS:
Corporate and Investor RelationsPaul Sagan
LaVoieHealthScience
(617) 865-0041
psagan@lavoiehealthscience.com
Media
Andrew Korda
LaVoieHealthScience
(617) 865-0043
akorda@lavoiehealthscience.com
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