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PONTE VEDRA, Fla., December 31, 2024--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) today recapped its 2024 milestones and highlighted a clear path forward to develop the investigational drug tecarfarin as a superior and safer chronic anticoagulant therapy for warfarin-dependent patients with implanted cardiac devices including left ventricular assist devices (LVAD) or for those with rare cardiovascular conditions.

"This year has marked significant opportunities and advancements for Cadrenal Therapeutics, with a strong focus on clinical indications," said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. "The Company has established a targeted plan to advance the clinical development of tecarfarin and, if approved, to commercialize it as a significant improvement for LVAD patients facing challenges with chronic anticoagulation treatments. We look ahead to 2025 and the initiation of the pivotal Phase 3 clinical trial for tecarfarin in LVAD and developing this much-needed therapeutic solution for advanced heart failure patients with implanted LVADs."

2024 Year-End Highlights:

• FDA Engagement and Tecarfarin Development: Cadrenal Therapeutics held a Type B meeting with the U.S. Food and Drug Administration (FDA) regarding the pivotal Phase 3 clinical trial protocol for tecarfarin in LVAD patients. The Company remains in discussion with the FDA to further refine the trial and expects to provide updates on the anticipated trial in Q1 2025.

• Strategic Development Collaborations: Cadrenal Therapeutics continues to explore collaboration with potential development partners to advance tecarfarin’s pivotal clinical trial for patients with LVAD and other rare cardiovascular conditions.

• Financial Growth and Fundraising Success: Cadrenal Therapeutics raised approximately $9.8 million in recent financing transactions, including $5.1 million through an at-the-market (ATM) facility and $4.7 million from warrant exercises, boosting its cash balance to $11.3 million as of November 2024.

• Industry Recognition and Engagement: In October 2024, Cadrenal Therapeutics joined the Corporate Council of the Anticoagulation Forum (AC Forum). This association will enable the Company to collaborate with anticoagulation therapy thought leaders and 15,000 healthcare professionals to improve anticoagulation outcomes for patients globally. In November 2024, Cadrenal Therapeutics was named Anticoagulation Therapy Company of the Year by Pharma Tech Outlook, an industry publication focused on breakthrough pharmaceutical technologies.

• Operational Milestones: The Company and its pharmaceutical Contract Development and Manufacturing Organization (CDMO) completed necessary operational readiness activities to supply clinical trial materials for the upcoming tecarfarin pivotal Phase 3 trial in compliance with current Good Manufacturing Practices (cGMP). Cadrenal Therapeutics has also conducted market research in multiple indications, including LVAD, research that reinforces Cadrenal Therapeutics’ commitment to continuing pre-commercial work for tecarfarin.

• Orphan Drug Designation for Tecarfarin: In April 2024, Cadrenal Therapeutics received FDA Orphan Drug Designation (ODD) for tecarfarin to prevent thromboembolism in patients with LVADs and other mechanical circulatory support devices, underscoring the investigational drug’s potential impact on rare cardiovascular conditions. Tecarfarin also has ODD and Fast Track designation from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).

• Leadership: Cadrenal appointed Jeff Cole as Chief Operating Officer to oversee manufacturing, supply chain operations, intellectual property, and commercialization strategies.

• Scientific Advocacy and Clinical Evidence: The clinical need for tecarfarin was highlighted at the November 2024 European Association for Cardio-Thoracic Surgery (EACTS) Mechanical Circulatory Support Summit in an address by Mandeep R. Mehra, MD, The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and Professor, Harvard Medical School. Dr. Mehra presented compelling data on the limitations of warfarin for LVAD patients and the potential of tecarfarin, if approved, to provide a safer alternative to these patients.