Cadrenal Therapeutics (CVKD) Investor presentation summary

Disease overview and unmet need

• Heparin-induced thrombocytopenia (HIT) is a severe, immune-mediated condition with high rates of thrombosis, morbidity, and mortality, affecting up to 12 million patients annually in the U.S.

• HIT leads to a dramatic increase in complications, hospital stays, and costs, with mortality and limb loss rates significantly higher than non-HIT patients.

• The addressable HIT patient population in the U.S. is estimated at 154,000, with a projected increase to 188,000 by 2037.

Product and mechanism of action

• CAD-1005 is a first-in-class, selective 12-LOX inhibitor targeting immune-driven platelet activation, directly addressing the root cause of HIT.

• Unlike current therapies that only target thrombus formation, CAD-1005 interrupts the platelet activation cycle without increasing bleeding risk.

• Phase 1 and 2 trials showed CAD-1005 was well-tolerated, with no increased bleeding and a >25% absolute reduction in thrombotic events versus placebo.

Clinical development and regulatory status

• Phase 2 trial demonstrated a reduction in thrombotic events on top of standard care, though not powered for statistical significance; sets the stage for pivotal Phase 3.

• Phase 3 will be a randomized, blinded, placebo-controlled study focusing on clinically meaningful thrombotic events, with interim analyses planned.

• FDA Fast Track and Orphan Drug Designation have been granted in the US and EU, with Phase 3 initiation targeted for the second half of 2027.