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NASDAQ:CVKD
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Business Update
Gearing Up for Phase 3 Trial of Tecarfarin
Cadrenal Therapeutics, Inc. (NASDAQ:CVKD) is a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant intended to prevent heart attacks, stroke, and death due to blood clots in patients suffering from rare cardiovascular conditions requiring chronic anticoagulation. These conditions include patients with left ventricular assist devices (LVADs), patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with mechanical heart valves with difficult-to-control time in therapeutic range (TTR).
The company is currently preparing for the Phase 3 TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Recently, Cardrenal announced a collaboration agreement with Abbott in which Abbott will 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.
In February 2025, Cadrenal conducted a Type D meeting with the U.S. FDA at which time the agency provided additional guidance on the design of the planned Phase 3 trial. The FDA requested that Cadrenal provide a full study design synopsis and detailed clinical trial design for review. Tecarfarin was previously granted Orphan Drug Designation (ODD) by the FDA.
During the past year, Cadrenal and its Contract Development and Manufacturing Organization (CDMO) completed activities in support of producing clinical trial materials for the upcoming Phase 3 trial in compliance with current Good Manufacturing Practices (cGMP).
Currently, we anticipate initiation of the TECH-LVAD study in the second half of 2025.
Financial Update
On March 13, 2024, Cadrenal announced financial results for 2024. As expected, the company did not record any revenues in 2024. R&D expenses in 2024 were $4.2 million compared to $4.1 million in 2023. The 2023 expenses included a $3.0 million stock issuance to HESP LLC pursuant to an amendment to the Asset Purchase Agreement. Excluding the $3.0 million stock expense in 2023, expenses increased $3.1 million in 2024, mostly due to increased CMC costs, consulting fees, and personnel-related expenses. G&A expenses were $6.8 million in 2024 compared to $3.5 million in 2023. The increase was primarily due to increased personnel-related expenses, public company expenses, non-cash stock-based compensation, and other general and administrative expenses.