Cadrenal Therapeutics Third-Quarter Update

Cadrenal Therapeutics, Inc., a late-stage biopharmaceutical firm based in Ponte Vedra, Florida, is focused on the development of tecarfarin, a novel vitamin K antagonist (VKA). This new anticoagulant aims to provide safer and superior anticoagulation therapy for patients with implanted cardiac devices or rare cardiovascular conditions. On November 7, 2024, the company provided an update coinciding with its Quarterly Report on Form 10-Q for the quarter ending September 30, 2024.

In September, Cadrenal's leadership engaged with the U.S. Food and Drug Administration (FDA) to discuss the Phase 3 clinical trial protocol for tecarfarin in patients with left ventricular assist devices (LVAD). These discussions are ongoing. Additionally, Cadrenal has been advancing talks with Abbott concerning a pivotal clinical trial involving patients with the Abbott LVAD HeartMate 3, currently the only LVAD available in the U.S.

In October 2024, the company joined the Corporate Council of the Anticoagulation Forum (AC Forum), the largest professional organization dedicated to improving chronic anticoagulation care worldwide. By participating in the Corporate Council, Cadrenal will collaborate with AC Forum to educate and engage its 15,000 healthcare professional members aimed at enhancing patient outcomes on anticoagulants.

Cadrenal has completed operational readiness activities with its pharmaceutical contract development and manufacturing organization (CDMO) to ensure the supply of active pharmaceutical ingredients and clinical trial materials in compliance with current good manufacturing principles (cGMP).

On October 24, 2024, Cadrenal successfully raised approximately $5.1 million through its at-the-market facility (ATM). Furthermore, on November 1, 2024, the company announced the exercise of warrants, generating gross proceeds of around $4.7 million. These recent financial transactions, totaling $9.8 million, have increased Cadrenal's cash balance to approximately $11.3 million, bolstering its balance sheet and providing additional working capital as it advances tecarfarin toward a pivotal Phase 3 trial.

In the third quarter of 2024, Cadrenal's operating expenses were $2.5 million, including $0.3 million of non-cash expenses. The company used $2.2 million in operating activities during this period. As of November 7, 2024, Cadrenal reported a cash and cash equivalent balance of $11.3 million.

Quang X. Pham, Founder, Chairman, and Chief Executive Officer of Cadrenal Therapeutics, remarked on the company's progress, highlighting the achievement of several critical milestones toward commencing a pivotal clinical trial to evaluate tecarfarin's superiority to warfarin in LVAD patients. Pham emphasized that these accomplishments span finance, operations, partner relations, and clinical development, enhancing Cadrenal's strategic execution as it moves into 2025.

Tecarfarin is distinguished as the only anticoagulant in development globally for patients with implanted cardiac devices and other rare cardiovascular conditions. This oral, reversible drug aims to overcome the challenges associated with warfarin, addressing an unmet need for patients where direct oral anticoagulants (DOACs) are contraindicated or not recommended by leading cardiology associations. If approved, tecarfarin could offer a safer and more effective chronic anticoagulation solution for LVAD patients in the United States.

Additionally, tecarfarin may be beneficial for patients where warfarin fails to provide adequate anticoagulation due to genetic resistance or renal impairment, complicating warfarin metabolism. This includes individuals with end-stage renal disease or atrial fibrillation and those with mechanical heart valves struggling with anticoagulation control, as determined by International Normalized Ratio (INR) measurements—a critical measure of blood clotting time.

Cadrenal Therapeutics continues to focus on developing tecarfarin to offer a safer, more effective chronic anticoagulant for patients with implanted cardiac devices or rare cardiovascular conditions. The company plans to evaluate tecarfarin's efficacy and safety in pivotal clinical trials, aiming to address the limitations and adverse events associated with current anticoagulation therapies.