• New high-value indication for Phase 3-ready asset with data intended to support clinical development and strategic partnering discussions
  • Additional billion-dollar target- Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), a serious complication affecting 35,000 U.S. patients annually, with no approved FDA-approved targeted therapies
  • Dual-Purpose Synergy - Planned Phase 2a proof-of-concept trial expected to generate safety, renal injury signals, and 12-LOX pathway biology in high-risk cardiac surgery patients, while generating high-value data potentially relevant to the Company's lead HIT indication
  • Capital-Efficient Development: Leverages shared in-hospital ICU infrastructure and an intravenous (IV) formulation to offer a turnkey critical care franchise for a global pharmaceutical partner
  • Maximizes 12-LOX Platform Valuation – Strongly positioned for upcoming strategic collaboration and licensing meetings at BIO 2026
     

PONTE VEDRA, Fla., June 15, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (NASDAQ:CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced that it plans to initiate a Phase 2a proof-of-concept clinical trial of its lead drug candidate, CAD-1005, being studied to prevent Acute Kidney Injury (AKI) in high-risk patients undergoing cardiac surgery. The trial is expected to begin later this year.

The planned study is intended to expand the clinical evaluation of CAD-1005 into a high-unmet-need acute-care setting while generating data that may be relevant to Cadrenal's lead Phase 3-ready program in heparin-induced thrombocytopenia (HIT). HIT is a condition caused by an immune response to the widely used hospital blood thinner, heparin, resulting in blood clots that can cause death, amputation, stroke, and significantly increase healthcare costs. The Company expects to discuss the CSA-AKI clinical plan, its implications for CAD-1005's broader development strategy, and potential non-dilutive collaboration opportunities at the BIO International Convention.