Cadrenal Therapeutics, Inc. announced late-breaking Phase 2 data demonstrating that its first-in-class 12-lipoxygenase (12-LOX) inhibitor CAD-1005 achieved an absolute reduction of more than 25% in thrombotic events for patients with Heparin-Induced Thrombocytopenia (HIT). The findings were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The data support the clinical advancement of the program, which is Phase 3-ready, targeting a condition with an estimated $2 billion in peak annual revenue and no currently approved root-cause therapies.

The oral presentation, delivered by Principal Investigator Dr. Steven E. McKenzie, highlighted CAD-1005 as the first randomized, blinded, placebo-controlled trial in HIT. The study was selected as one of three late-breakthrough abstracts in the clinical trials and innovation in thrombosis category. The event attracted over 6,000 registrants and more than 3,100 abstract submissions, marking the largest in-person audience for the ISTH Congress in over a decade.

Key Phase 2 Findings

The trial results indicated that patients treated with CAD-1005 experienced a reduction of more than 25% in new or worsening thrombotic events compared with the placebo arm. The data showed an event rate of 50% for the CAD-1005 group versus greater than 75% for the placebo arm, despite the study not being sufficiently powered for statistical significance.

Safety and Mechanism

The safety profile showed no serious adverse events attributable to CAD-1005, no major bleeding in SRA+ patients, and no deaths. Treatment was associated with fewer thromboembolic events without an increase in major bleeding. Unlike standard-of-care anticoagulants that only reduce thrombin generation, CAD-1005 is designed to directly block the underlying 12-LOX immune signaling loop that drives antibody-mediated platelet activation.

Regulatory Status and Pipeline

CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) and Orphan Drug status from the European Medicines Agency (EMA). Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics, stated that the company is well-positioned to advance partnering opportunities for CAD-1005 and tecarfarin following recent financing. The company's pipeline also includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots.

Cadrenal Therapeutics, Inc. has entered into a definitive agreement with a healthcare-focused institutional investor to raise gross proceeds of up to $8.8 million through a private placement priced at-the-market under Nasdaq rules. The transaction includes the issuance and sale of 960,000 shares of common stock (or pre-funded warrants in lieu thereof), along with series C-1 and series C-2 warrants to purchase up to an aggregate of 960,000 shares each. The combined purchase price is set at $3.125 per share. The potential additional gross proceeds from the full exercise of the warrants could reach approximately $5.8 million.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The securities are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D. The company has agreed to file registration statements with the Securities and Exchange Commission (SEC) to cover the resale of the unregistered securities issued in the offering. The transaction is expected to close on or about July 1, 2026, subject to customary closing conditions.

The series C-1 warrants carry an exercise price of $3.00 per share and are exercisable upon stockholder approval, expiring five years after the later of the stockholder approval date or the effective date of a resale registration statement. The series C-2 warrants also have an exercise price of $3.00 per share, are exercisable immediately upon issuance, and expire twenty-four months after the effective date of a resale registration statement. There is no assurance that the warrants will be exercised or that the company will receive cash proceeds from their exercise.

Cadrenal Therapeutics intends to use the net proceeds from the offering for working capital purposes. The company anticipates that the upfront proceeds will extend its cash runway into the first quarter of 2027. If the warrants are exercised in full for cash, the cash runway is expected to extend into the second half of 2027. This extension is intended to advance partnering opportunities for tecarfarin in Kawasaki Disease and CAD-1005 in Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and heparin-induced thrombocytopenia (HIT).

Key Offering Details

Cadrenal Therapeutics is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for HIT and CSA-AKI, having received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. The company's pipeline also includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation.