• Opportunistically Pursuing Business Development Initiatives with a Longer-Term Focus on Creating a Pipeline of Cardiovascular Therapeutics.

• FDA Fast Track and Orphan Drug Designations Obtained.

• New Chief Medical Officer Appointment Strengthens Strategic and Development Capabilities.

• FDA Type D Meeting Provides Additional Guidance for Advancing Clinical Development of Flagship Anticoagulant Drug tecarfarin.

• Aiming to Reduce the Clinical Complexities of Warfarin and Capture Value in a Market with High Demand for Safer, More Manageable Treatment.

• Collaboration Agreement with Abbott (NYSE: ABT) Validates the Need for New Anticoagulation Options.

• Research Indicates tecarfarin is Uniquely Positioned to Provide Clinical Value in the Rapidly Growing LVAD Market, Projected to Nearly Double by 2032.

• Technical & Manufacturing of tecarfarin Transferred from Asia to US for Support of Clinical and Regulatory Strategy and to Improve Supply Chain Security.

• Participation in Key Investor, Medical, and Business Development Conferences.

• Positioned for Huge Revenue Growth in a $34 Billion Market for 2025 Advancing to $45 Billion in 2026.

• CVKD is a Lean Stock, with a Public Float of Less Than 2 Million Shares.

Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. The CVKD 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, CVKD 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. FDA Fast Track and Orphan Drug Designations have already been obtained.

CVKD is pursuing a pipeline-in-a-product approach with tecarfarin. The CVKD tecarfarin product received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). CVKD 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.

CVKD is being positioned for huge revenue growth in a $34 Billion Market for 2025 Advancing to $45 Billion in 2026. For investors CVKD offers a very small share structure with a public float of less than 2 million which should allow the stock to move easily in response to positive developments.

First-Quarter 2025 Corporate Update

On May 8th CVKD 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.

Highlights

In February CVKD 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:

Also is February CVKD 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 CVKD announced a Collaboration Agreement with Abbott (NYSE: ABT) to support its 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, CVKD 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.

CVKD 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, and Business Development Conferences:

CVKD 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 43rd 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 18th National Conference on Anticoagulation Therapy in Washington, D.C.

Strategic Development Collaborations:

CVKD 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.

For more information on $CVKD visit: https://www.cadrenal.com/ and https://pennystocksunited.com/cvkd

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Media Contact
Company Name: Cadrenal Therapeutics, Inc.
Contact Person: Quang X. Pham, Chairman & CEO
Phone: (904) 300-0701
Address:822 A1A North Suite 306
City: Ponte Vedra Beach
State: Florida
Country: United States
Website: https://www.cadrenal.com/