Can you describe Cadrenal Therapeutics and its mission?

Cadrenal Therapeutics (Nasdaq: CVKD) is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options. Cadrenal recently announced a collaboration with Abbott. Can you provide details?

In March 2025, we signed a collaboration agreement with Abbott (NYSE: ABT) to support our pivotal TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices (TECH-LVAD) trial. Abbott will support us in planning and executing our TECH-LVAD trial to evaluate the efficacy and safety of tecarfarin in patients with LVADs. Abbott will further support us with trial design, site identification, trial awareness and HeartMate 3™ expertise. Abbott’s HeartMate 3™ LVAD is the most advanced LVAD in production and the only one currently available in the United States.

This collaboration will help advance our commitment to bringing patients the first innovation in vitamin K-targeted anticoagulation in more than 70 years. What makes tecarfarin different from existing anticoagulants like warfarin?

Tecarfarin is a small-molecule VKA, taken once daily as an oral anticoagulant, similar to warfarin. However, its key differentiator lies in its metabolism. Unlike warfarin, tecarfarin is not metabolized through the CYP450 enzyme pathway, which reduces the risk of drug-drug interactions. Another major distinction is that renal impairment does not affect the half-life and pharmacokinetics of tecarfarin, whereas it does with warfarin. This makes tecarfarin particularly promising for patients with kidney disease who require stable and reliable anticoagulation.

Tecarfarin has the potential to be superior to warfarin, resulting in fewer adverse events such as strokes, bleeding events, and heart attacks for patients with rare cardiovascular conditions. What are the challenges with current treatments, and how does tecarfarin address them?

Patients with LVADs, end-stage renal disease with atrial fibrillation, or mechanical heart valves all face high risks from current anticoagulation therapies. Warfarin’s variable metabolism and narrow therapeutic window, as well as significant drug interactions, require constant monitoring, making it challenging to maintain appropriate anticoagulation levels for these high-risk patient populations. And direct oral anticoagulants, or DOACs (Eliquis-class drugs), are often contraindicated or ineffective for patients with advanced kidney disease or LVADs.

Tecarfarin addresses this treatment gap by offering consistent anticoagulation without being affected by renal impairment, making it a potential game-changer for these underserved patients. What is your pipeline approach, and what is the status of Cadrenal Therapeutics’ clinical trials?

Cadrenal is pursuing a pipeline-in-a product approach with tecarfarin, which has received orphan drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including left ventricular assist devices or LVADs. We have also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation.

Tecarfarin is Phase 3-ready with a positive safety profile, having been evaluated in 11 human clinical trials with more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in healthy adults and patients with ESKD and chronic kidney disease (CKD).

We are currently working with the FDA on the design of a pivotal Phase 3 clinical trial for tecarfarin. This will be a double-blind study comparing tecarfarin to warfarin, evaluating the efficacy and safety of tecarfarin in patients with LVADs. What are your priorities moving forward?

Cadrenal is opportunistically pursuing business development initiatives with a long-term focus on building a pipeline of specialized cardiovascular therapeutics.

With the only new VKA blood thinner being developed for warfarin-dependent patients with implanted cardiac devices or rare cardiovascular conditions, Cadrenal is challenging the status quo to innovate a new anticoagulant that can improve the lives of the thousands of underserved patients who suffer from these serious medical conditions.