Cadrenal Therapeutics, Inc.

The Company is a late-stage biopharmaceutical company focused on developing new treatments for serious immune and thrombotic conditions. Following the acquisition of a 12-lipoxygenase ("12-LOX") platform of assets in December 2025, the company shifted its main strategic focus to developing CAD-1005 for immune-mediated and thrombotic disorders. The company's primary product candidate, CAD-1005, is a selective 12-LOX inhibitor designed to treat heparin-induced thrombocytopenia ("HIT"), a severe immune-mediated thrombotic disorder. CAD-1005 has been tested in a blinded, placebo-controlled Phase 2 clinical trial involving 24 patients, and in Phase 1 clinical trials with over 100 patients. On March 26, 2026, the company completed its End-of-Phase 2 ("EOP2") meeting with the FDA, clarifying a potential path for its planned Phase 3 pivotal trial of CAD-1005 in HIT patients. CAD-1005 has received an orphan drug designation ("ODD") from the FDA for preventing thrombosis in HIT patients, an FDA Fast Track designation for treating and preventing HIT, and an orphan designation from the EMA for treating platelet-activating factor 4 disorders. The company's pipeline also includes two other clinical-stage assets: tecarfarin and frunexian. Tecarfarin is an oral vitamin K antagonist ("VKA") intended as a warfarin replacement for patients with complex needs, designed to prevent heart attacks, strokes, and deaths from blood clots in patients needing chronic anticoagulation. The focus for tecarfarin is for chronic use in patients with kidney dysfunction or left ventricular assist devices ("LVADs"), specifically designed to overcome metabolic factors that can make warfarin less reliable. Frunexian is a Phase 2-ready intravenous ("IV") Factor XIa inhibitor, intended for acute care settings where medical devices or artificial surfaces significantly activate coagulation.