CVKD — Cadrenal Therapeutics Inc.

Status note First-in-class 12-LOX inhibitor designed to selectively inhibit 12-lipoxygenase, central to platelet immune activation and thrombo-inflammatory signaling in HIT. EOP2 meeting with FDA completed; pivotal registration design is a 120-patient randomized, blinded, placebo-controlled Phase 3 evaluating CAD-1005 added to standard of care, primary endpoint new or worsening thrombotic events in SRA-confirmed HIT, NDA submission projected 2029. FDA Orphan Drug Designation for prophylaxis of thrombosis in HIT, Fast Track for treatment and prevention of HIT, EMA orphan designation for platelet-activating factor 4 disorders. Company does not currently have funding to commence or complete Phase 3 and will not start trials until funding is secured; corporate strategy pivoted to out-licensing, co-development or acquisition.

Status note Late-stage oral vitamin K antagonist for chronic anticoagulation in end-stage kidney disease, LVAD patients, and potentially Kawasaki disease. Company is seeking pediatric cardiology networks in the U.S. and Japan to finalize a Phase 3 trial design evaluating time in therapeutic range (TTR) in pediatric Kawasaki patients with giant coronary artery aneurysms. FDA Orphan Drug and Fast Track designations received.

Status note Investigational intravenous Factor XIa inhibitor intended to provide anticoagulation for patients undergoing major cardiac surgery; part of the Cardiac Acute Critical Care Franchise. Development milestones in the eXIthera APA reference first patient dosed in a Phase 2 frunexian study.

Status note Second-generation 12-LOX oral therapeutics in preclinical development for chronic cardiorenal inflammatory and thrombotic indications; positioned as an oral follow-on companion to CAD-1005.