Cadrenal Therapeutics (CVKD) Summer 2024 Investor Summit Virtual MicroCap Forum summary

Company overview and product focus

• Focused on Tecarfen, a late-stage vitamin K antagonist anticoagulant for patients with implanted heart devices and rare cardiovascular conditions.

• Tecarfen has completed extensive phase 1, 2, and 3 trials in over 1,000 patients.

• FDA has granted Tecarfen multiple orphan drug and fast track designations.

• No FDA-approved anticoagulant exists for LVAD patients; current standard is warfarin, which has significant drawbacks.

• Tecarfen is designed to overcome warfarin's limitations, offering more stable and effective anticoagulation.

Market need and competitive landscape

• Patients with LVADs or rare cardiovascular conditions have no alternatives to warfarin, which is inadequate and risky.

• DOACs (Eliquis, Xarelto) are not approved or effective for these populations and will soon lose patent protection.

• Factor XI inhibitors are in development but not being studied for these rare conditions.

• Physicians and payers express frustration with current options and see strong potential for Tecarfen adoption.

• Addressable U.S. market for Tecarfen is estimated at $2 billion.

Clinical evidence and regulatory status

• Tecarfen has shown stable anticoagulation and fewer major bleeding events compared to warfarin in a 607-patient phase 2/3 study.

• Eleven clinical studies and over 1,000 subjects support Tecarfen's safety and efficacy.

• Orphan and Fast Track designations provide incentives, including seven years of market exclusivity upon approval.

• Only one pivotal phase 3 trial remains before FDA submission.

• Collaboration initiated with Abbott, the sole U.S. LVAD manufacturer, to advance Tecarfen.