Cadrenal Therapeutics (CVKD) Investor presentation summary

Portfolio highlights and strategic focus

• Advancing a late-stage portfolio targeting cardiac acute critical care and orphan diseases, with peak annual revenue potential exceeding $3 billion.

• Three orphan drug designations from the FDA and additional regulatory acceleration pathways, including Fast Track and EMA orphan status.

• Over $200 million invested in programs to date, supporting a de-risked, late-stage pipeline.

• Flexible partnering structures available, including co-development, commercial, and geographic licensing.

Lead assets and clinical development

• CAD-1005 (onvoloxastat) is a first-in-class, highly selective 12-LOX inhibitor for HIT and CSA-AKI, with Phase 3 and Phase 2a readiness, respectively.

• Tecarfarin, a next-generation VKA, addresses gaps in chronic anticoagulation for high-risk and orphan populations, with orphan and fast-track designations.

• Frunexian, an intravenous Factor XIa inhibitor, is Phase 2 ready for acute care use, with an orphan drug designation application prepared.

Clinical and regulatory progress

• CAD-1005 demonstrated >25% absolute reduction in thrombotic events in Phase 2 HIT study and was well-tolerated in Phase 1.

• Planned pivotal Phase 3 study for CAD-1005 in HIT will focus on clinically meaningful thrombotic events, with interim analyses and global expansion.

• Tecarfarin showed stable exposure in CKD patients and favorable safety in Phase 2/3 EMBRACE-AC trial, with low major bleeding and no thrombotic events.