0001213900-26-036937
SEC filingCadrenal Therapeutics reported Q4 and FY 2025 financial results with reduced net loss, $4.0 million cash position, and progress on CAD-1005 Phase 3 trial following positive FDA End-of-Phase 2 meeting.
Cadrenal Therapeutics issued its Q4 and full-year 2025 financial results alongside a significant clinical update on its lead asset CAD-1005, a first-in-class 12-LOX inhibitor for heparin-induced thrombocytopenia (HIT). The Phase 2 trial delivered encouraging efficacy data, demonstrating a greater than 25% absolute reduction in new or worsening thrombotic events compared to placebo when added to standard anticoagulant therapy, addressing a critical unmet need in this life-threatening condition with high mortality (up to 18-20%) and amputation risks. The End-of-Phase 2 FDA meeting on March 26, 2026, provided clarity on a potential registrational Phase 3 path, with protocol incorporation underway, reinforcing CAD-1005 as the near-term priority backed by Orphan Drug, Fast Track, and EMA orphan designations.
Financially, Q4 R&D expenses declined 53% to $0.7 million from $1.5 million year-over-year, reflecting efficient resource allocation post-Phase 2 completion, while G&A edged down to $2.4 million from $2.7 million. Full-year operating expenses rose to $13.5 million from $11.0 million, driven by higher G&A, yielding a net loss of $13.2 million ($6.64/share) versus $10.7 million ($8.73/share) in 2024, partially offset by interest income. Balance sheet shows $4.0 million in cash as of December 31, 2025, down from $10.0 million, with 2.3 million shares outstanding. Management is pursuing financing and strategic alternatives to support Phase 3 initiation, highlighting capital constraints amid promising clinical momentum. CEO Quang X. Pham emphasized CAD-1005's differentiated potential in HIT while noting broader 12-LOX opportunities in obesity and diabetes.