Cadrenal Therapeutics Q2 2024 Corporate Update

PONTE VEDRA, Fla., Aug. 7, 2024 - Cadrenal Therapeutics, Inc., a biopharmaceutical company listed on Nasdaq as CVKD, is developing tecarfarin, a novel Vitamin K Antagonist (VKA). Tecarfarin is an oral and reversible anticoagulant aimed at preventing heart attacks, strokes, and fatalities due to blood clots in patients with implanted cardiac devices and those suffering from rare cardiovascular conditions. The company has recently provided a corporate update in conjunction with its Quarterly Report on Form 10-Q for the quarter ending June 30, 2024.

Key Developments

Cadrenal Therapeutics and Abbott have initiated a joint venture to push forward the development of tecarfarin specifically for patients using left ventricular assist devices (LVADs). Abbott's HeartMate 3™ is currently the sole LVAD available in the U.S. and has demonstrated superior performance compared to previous models.

In April 2024, tecarfarin was granted FDA Orphan Drug Designation (ODD), specifically for the prevention of blood clots and strokes in patients with LVADs and other mechanical circulatory support systems.

During the International Society for Heart & Lung Transplantation's 44th Annual Meeting in April 2024, Dr. Mandeep Mehra presented a significant secondary data analysis from the ARIES-HM3 study, which was sponsored by Abbott. The study highlighted the limitations of warfarin and the necessity for a new VKA therapy for patients with unique cardiovascular conditions. Dr. Mehra stated, "Tecarfarin could emerge as a vital treatment for LVAD patients who require continuous anticoagulation. Unlike warfarin, it is not influenced by drug interactions or kidney function changes and warrants further exploration."

Additionally, Cadrenal has engaged pharmaceutical contract development and manufacturing organizations to ensure the supply of active pharmaceutical ingredients and clinical trial materials.

Financial Update

The company's operating expenses for Q2 2024, excluding non-cash items, amounted to $2.3 million, with $1.5 million used in operating activities during this period. As of June 30, 2024, Cadrenal Therapeutics had cash reserves totaling $5 million.

"We're making substantial strides in our pivotal trial to assess tecarfarin's efficacy for LVAD patients," said Quang Pham, Founder, Chairman, and CEO of Cadrenal Therapeutics. "Following the acquisition of tecarfarin's orphan drug designation in April 2024, our collaboration with Abbott has intensified to expedite tecarfarin’s development. Our team is formulating an LVAD study protocol and is keen to proceed with Phase 3 trials, aiming to demonstrate tecarfarin’s superiority over warfarin for LVAD patients. Our goal is to offer a superior anticoagulation solution to those in need."

Potential Impact of Tecarfarin

Tecarfarin stands out as the only oral anticoagulant in development globally for patients with implanted cardiac devices and various rare cardiovascular conditions. Designed to address numerous challenges posed by warfarin, tecarfarin could be the sole on-label drug for LVAD patients in the U.S. if approved.

Furthermore, tecarfarin may be beneficial for patients where warfarin is ineffective due to genetic resistance or renal impairment that complicates warfarin metabolism. This includes patients with end-stage renal disease and atrial fibrillation, as well as those with mechanical heart valves and difficult-to-control International Normalized Ratio (INR), which measures blood clotting time.

Upcoming Events

Cadrenal Therapeutics has scheduled presentations at several investment conferences:
- Sidoti Micro Cap Conference: August 14-15, 2024
- Summer 2024 Investor Summit: August 20, 2024
- Emerging Growth Conference: August 21, 2024
- H.C. Wainwright 26th Annual Global Investment Conference: September 9-11, 2024

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics focuses on developing tecarfarin to meet unmet needs in anticoagulation therapy. Tecarfarin is a late-stage, innovative oral and reversible anticoagulant aimed at preventing heart attacks, strokes, and deaths from blood clots in patients with implanted cardiac devices and those with rare cardiovascular conditions. The drug has secured multiple FDA designations, including orphan drug designation for preventing thrombosis in patients with ventricular assist devices (VADs). It has also received orphan drug and fast-track designations for preventing systemic thromboembolism in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Tecarfarin leverages a different metabolic pathway compared to warfarin, the most traditionally prescribed Vitamin K Antagonist. The drug has been tested in eleven human clinical trials involving over 1,000 participants and has generally been well-tolerated.