By David Bautz, PhD
READ THE FULL CVKD RESEARCH REPORT
Business Update
Collaboration Agreement with Abbott for Phase 3 TECH-LVAD Trial
On March 4, 2025, Cadrenal Therapeutics, Inc. (NASDAQ:CVKD) announced a collaboration agreement with Abbott for the Phase 3 TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. In August 2024, Cadrenal had announced it was in discussions with Abbott about the pivotal Phase 3 trial of tecarfarin for patients with LVADs, and this agreement between the two companies is the result of those discussions. Specifically, the agreement calls for Abbott to assist Cadrenal with trial design, site identification, trial awareness, and HeartMate 3 expertise. Abbott is the maker of the HeartMate 3 LVAD, which is the only LVAD currently approved in the U.S.
Having Abbott assist with many different facets of the Phase 3 TECH-LVAD trial is going to be a huge advantage for Cadrenal as Abbott has a wealth of experience with LVAD patients. The agreement will allow Cadrenal to utilize Abbott’s network of trial sites and investigators that are familiar with LVAD devices and that patient population, which we believe may expedite patient enrollment.
Previous study results for patients using the HeartMate 3 have shown that while anticoagulation therapy with warfarin is required for this patient population, fewer than 50% of patients are in the target range for proper anticoagulation (Mehra et al., 2022) (Mehra et al., 2023). These data strongly support the idea that an improved anticoagulation treatment is necessary for LVAD patients, which we believe tecarfarin has the potential to do.
Cadrenal is continuing discussions with the FDA on the finalized design for the pivotal Phase 3 trial of tecarfarin in LVAD patients, for which the FDA had previously granted Orphan Drug Designation (ODD). We anticipate an update on the TECH-LVAD trial in the first quarter of 2025 and the trial to initiate in the second half of 2025.
New Chief Medical Officer
In February 2025, Cadrenal announced the appointment of James J. Ferguson, MD, FACC, FAHA as Chief Medical Officer (CMO). Dr. Ferguson brings over 25 years of experience in the cardiovascular field and clinical development. Previously, Dr. Ferguson was CMO at Matinas BioPharma and prior to that he was Head of U.S. Cardiovascular Medical Affairs at Amgen and held several senior positions at AstraZeneca.
Conclusion
Now that the agreement with Abbott is complete, we look forward to updates from the company regarding the finalized Phase 3 protocol and timelines for the trial initiation. Having Abbott as a partner for the Phase 3 trial is a tremendous opportunity for the company as Abbott has extensive experience working with LVAD patients and conducting successful trials with that population. With no changes to our model our valuation remains at $30 per share.
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