Cadrenal Therapeutics Announces Collaboration Agreement with Abbott in Support of Pivotal Study of Tecarfarin in Patients with HeartMate 3™ LVAD

Cadrenal Therapeutics (CVKD) has announced a significant collaboration agreement with Abbott (ABT) to support their pivotal TECH-LVAD trial, evaluating tecarfarin in patients with Left Ventricular Assist Devices (LVADs).

The collaboration focuses on testing tecarfarin, a new oral Vitamin K antagonist (VKA), with Abbott's HeartMate 3™ LVAD, which is currently the only advanced mechanical circulatory support device available in the United States for patients with advanced heart failure.

Under the agreement, Abbott will provide support in:

• Trial design
• Site identification
• Trial awareness
• HeartMate 3™ expertise

The LVAD market, valued at $1.1 billion in 2023, is projected to reach $2.4 billion by 2032, according to Business Research Insights.

Positive

• Strategic collaboration with major healthcare company Abbott
• Access to key clinical trial sites and enhanced patient enrollment
• Targeting $1.1B LVAD market with projected growth to $2.4B by 2032
• First innovation in vitamin K anticoagulation in 70+ years

Negative

• Late-stage development implies significant ongoing R&D expenses
• Success dependent on clinical trial outcomes

Pharmaceutical Industry Analyst

This collaboration between Cadrenal Therapeutics and Abbott represents a significant strategicadvancement for Cadrenal's clinical development program. The agreement directly supports Cadrenal's pivotal TECH-LVAD trial for tecarfarin, their lead late-stage asset. Abbott's commitment to provide trial design expertise, site identification support, and access to HeartMate 3™ LVAD insights substantially de-risks the execution of this critical study.

The partnership provides Cadrenal with three key advantages: enhanced trial site access, improved patient enrollment capabilities, and validation from a global healthcare leader. For a company with Cadrenal's market cap ($32.7 million), securing support from Abbott significantly strengthens their clinical development position and potentially accelerates their regulatory pathway.

The LVAD market represents a substantial commercial opportunity, valued at $1.1 billion in 2023 with projected growth to $2.4 billion by 2032. Tecarfarin aims to address a critical medical need as potentially the first innovation in vitamin K-targeted anticoagulation in over 70 years. Successful development could position it as a preferred anticoagulant for LVAD patients.

While financial terms weren't disclosed, the non-monetary contributions from Abbott appear substantial. The collaboration structure focuses on clinical development support rather than direct investment, suggesting Abbott sees potential value in improving anticoagulation outcomes for their HeartMate 3™ LVAD patients, which could create future commercial synergies between the two companies' products.

Cardiology Medical Device Expert

This collaboration targets a critical unmet need in advanced heart failure management. Anticoagulation therapy is essential for LVAD patients to prevent thromboembolic complications, but current options present significant clinical challenges. Abbott's HeartMate 3™ LVAD, while the most advanced device in the U.S. market, still requires effective anticoagulation management to optimize patient outcomes.

The technical value of this partnership lies in combining Abbott's device expertise with Cadrenal's specialized anticoagulant. Abbott's willingness to share insights from recent HeartMate 3™ trials suggests they recognize potential benefits from improved anticoagulation specific to their device platform. This data sharing could help Cadrenal optimize their trial design to demonstrate tecarfarin's value specifically in this patient population.

From a clinical perspective, vitamin K antagonists have remained largely unchanged for decades despite their narrow therapeutic window and monitoring challenges. A new VKA specifically studied in LVAD patients could potentially address significant clinical management issues. The collaboration focuses on a well-defined patient population with clear anticoagulation needs, creating a focused regulatory and commercial pathway.

The strategic alignment between Cadrenal's anticoagulant therapy and Abbott's mechanical circulatory support technology could improve the overall therapeutic approach to advanced heart failure patients. If successful, this could establish a new standard of care for anticoagulation in LVAD therapy, particularly for the HeartMate 3™ platform that dominates the U.S. market.

Strengthens the Potential for Improved Patient Outcomes through Improvements in the Quality of Anticoagulation, Enhancing Hemocompatibility in HeartMate 3™ LVAD patients

PONTE VEDRA, Fla.--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD),a late-stage biopharmaceutical company focused on the development of specialized cardiovascular therapeutics, with the late-stage asset tecarfarin, a new oral Vitamin K antagonist (VKA), today announced the signing of a Collaboration Agreement with Abbott (NYSE: ABT) to support Cadrenal’s pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial.

Under the terms of the Collaboration and Data Sharing Agreement, Abbott will support Cadrenal 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 Cadrenal with: trial design, site identification, trial awareness, and HeartMate 3™ expertise.

“We are pleased to have the support of Abbott, a global healthcare leader, which further validates the advancement into late-stage clinical development of tecarfarin. This partnership strengthens our access to key clinical trial sites and enhances patient enrollment efforts,” said Quang X. Pham, Chief Executive Officer, Cadrenal Therapeutics, Inc. “Together, we have a unique opportunity to evaluate tecarfarin in combination with the HeartMate 3™ LVAD, advancing our commitment to bringing forward the first innovation in vitamin K-targeted anticoagulation in over 70 years.”

Abbott’s HeartMate​ 3™​ LVAD is a mechanical circulatory support device designed for patients with advanced heart failure. Abbott’s heart pumps have set the standard in LVAD therapy. The HeartMate 3™ LVAD is the most advanced LVAD yet and the only one currently available in the United States. According to Business Research Insights, the LVAD market was valued at $1.1 billion in 2023 and is projected to reach $2.4 billion by 2032.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developingspecialized 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).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular therapeutics. For more information, visit www.cadrenal.com and connect with us onLinkedIn.

Safe Harbor

Any statements contained 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 collaboration strengthening the potential for improved patient outcomes through improvements in the quality of anticoagulation enhancing hemocompatibility in HeartMate 3™ LVAD patients; Abbott supporting Cadrenal on the planning and execution of the TECH-LVAD trial to evaluate the efficacy and safety of tecarfarin in patients with LVADs; Abbott sharing insight from recent HeartMate 3™ trials and supporting Cadrenal w ith: trial design, site identification, trial awareness, and HeartMate 3™ expertise; the support of Abbott further validating the advancement into late-stage clinical development of tecarfarin; bringing forward the first innovation in vitamin K-targeted anticoagulation in over 70 years; meeting the unmet needs of LVAD patients by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges, Cadrenal building build a pipeline of specialized cardiovascular therapeutics and the LVAD market being projected to reach $2.4 billion by 2032. 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 and for Cadrenal to provide improved patients outcomes and efficacy and safety for LVAD patients; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, 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.

SOURCE Cadrenal Therapeutics, Inc.