Cadrenal Therapeutics (CVKD) investor relations material

Key announcements and strategic updates

• Recently in-licensed CAD-1005, an IV therapy for heparin-induced thrombocytopenia (HIT), now phase II complete and ready for phase III development.

• CAD-1005 demonstrated a promising reduction in thrombotic events in phase II, with no extra bleeding observed in phase I and II studies.

• The drug holds Orphan Drug and Fast Track status in the US and EU, targeting a significant unmet need in HIT.

• Phase III trial is planned to start in the first quarter, with a 24-month duration and estimated cost of $35–$40 million.

• End-of-phase II meeting with the FDA is scheduled to finalize trial design and endpoints.

Clinical development and trial design

• Phase III will focus on reduction in thrombotic events as the primary endpoint, with a 7–14 day treatment and 30-day follow-up.

• Trial will enroll under 200 patients, powered for superiority over placebo, with background anticoagulant therapy.

• Inclusion/exclusion criteria and site selection are critical to maximize trial success.

• CAD-1005 is intended for use in conjunction with current therapies, not as a replacement.

Mechanism of action and broader potential

• CAD-1005 is a 12-lipoxygenase inhibitor, addressing the underlying platelet activation in HIT, unlike current therapies that only treat clots.

• Preclinical data suggest potential in type 1 and type 2 diabetes and obesity-related inflammation.

• Plans to share preclinical findings to attract potential partners for broader indications.