By David Bautz, PhD
NASDAQ:CVKD
READ THE FULL CVKD RESEARCH REPORT
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, Cadrenal 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 most recent quarter, Cadrenal completed the technical transfer and manufacturing of tecarfarin drug substance (API) from a Contract Development and Manufacturing Organization (CDMO) in Asia to a CDMO in the U.S. This was done in accordance with the company’s strategy for tecarfarin and to improve supply chain security.
Currently, we anticipate initiation of the TECH-LVAD study in the second half of 2025.
Financial Update
On May 8, 2025, Cadrenal announced financial results for the first quarter of 2025. As expected, the company did not record any revenues for the three months ending March 31, 2025. R&D expenses in the first quarter of 2025 were $1.7 million compared to $0.6 million in the first quarter of 2024. The increase was primarily due to increased CMC costs, clinical trial preparation costs, stock-based compensation, and personnel-related expenses. G&A expenses were $2.3 million in the first quarter of 2025 compared to $1.1 million in the first quarter of 2024. The increase was primarily due to increased personnel-related expenses, public company expenses, and non-cash stock-based compensation
As of March 31, 2025, Cadrenal had approximately $7.3 million in cash and cash equivalents. Subsequent to the end of the quarter, the company sold 56,943 shares of common stock through its at-the-market (ATM) facility for net proceeds of approximately $876,000. While the company has sufficient capital to fund operations for the next 12 months, it will need to raise additional capital to conduct the planned Phase 3 tecarfarin trial. The company currently has approximately 2.0 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 3.0 million.
Conclusion
We look forward to additional updates from the company regarding the upcoming Phase 3 trial of tecarfarin in LVAD patients. 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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