Cadrenal Therapeutics, Inc.

What they do

Cadrenal is a clinical-stage biopharmaceutical company that acquires and advances drug candidates in immune and thrombotic disorders. Its lead asset, CAD-1005, is a first-in-class selective 12-LOX inhibitor that has completed a Phase 2 trial in 24 patients and Phase 1 trials in over 100 patients, and is being developed for HIT. The company also holds tecarfarin, an oral vitamin K antagonist being studied for chronic anticoagulation in kidney dysfunction or LVAD patients, and frunexian, a Phase 2-ready intravenous Factor XIa inhibitor for acute/critical care. Preclinical work includes CAD-2000, an oral 12-LOX inhibitor candidate.

Revenue drivers

• Pre-Operative Safety (Frunexian IV) — Frunexian is positioned as a pre-operative anticoagulant for HIT-susceptible patients undergoing coronary artery bypass graft (CABG) surgery; no revenue is generated yet as it remains in development.
• Orphan Regulatory Acceleration (CAD-1005) — Orphan Drug Designation strategy for HIT patients undergoing cardiac surgery; intended to support seven years of post-approval market exclusivity, fee waivers, and targeted tax credits, but no commercial revenue currently.
• Post-Operative Shield (CAD-1005) — CAD-1005 is being developed for Cardiac Surgery-Associated HIT and Cardiac Surgery-Associated Acute Kidney Injury, supported by Phase 2 data; remains pre-revenue.
• Tecarfarin and CAD-2000 — Tecarfarin is targeting chronic anticoagulation in kidney dysfunction or LVAD patients, and CAD-2000 is a preclinical oral 12-LOX inhibitor; both are developmental and contribute no current revenue.

Recent performance

The company is pre-revenue and reported no product sales in the latest quarter. For the second quarter ended June 30, 2026, Cadrenal had total assets of $5.6 million, total liabilities of $1.5 million, and shareholder equity of $4.1 million, with cash and equivalents of $2.4 million. Net loss for 2025 was $13.2 million, or $6.64 per diluted share, compared to a net loss of $10.7 million, or $8.73 per diluted share, in 2024. Operating cash flow was negative $12.6 million in 2025, compared to negative $7.4 million in 2024. The company reported a receivable from issuance of warrants of $2.7 million as of June 30, 2026.

Strategy

Cadrenal's primary focus is advancing CAD-1005 through a planned Phase 3 pivotal trial in HIT, following an End-of-Phase 2 meeting with the FDA on March 26, 2026, that clarified a potential registrational path. The company has organized its pipeline into a Cardiac Acute Critical Care Franchise with three pillars: pre-operative safety (frunexian), orphan regulatory acceleration (CAD-1005), and post-operative shielding (CAD-1005 for CSA-AKI). In July 2026, Cadrenal launched a structured partnering process to explore development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin, favoring out-licensing and co-development over independently funding late-stage trials. It is also pursuing nondilutive grants and submitted a request for Rare Pediatric Disease Designation for tecarfarin in Kawasaki Disease on July 8, 2026. The company continues preclinical development of CAD-2000.

Risks

• Going concern — The company's financial statements have been prepared assuming it will continue as a going concern, and its cash and proceeds from financings will only fund operations for a limited time.
• Need for additional capital — Cadrenal will need to raise additional capital, which may result in dilution to existing shareholders.
• Clinical and regulatory risk — Future success depends heavily on FDA review of the Phase 3 trial protocol and commencement of the Phase 3 clinical trial, and the 12-LOX platform is subject to significant clinical risks that could impede advancement of CAD-1005.
• No product revenue; history of losses — The company has a limited operating history, a history of losses, expects to continue to incur losses, and may never become profitable.

Outlook

Management stated that the second quarter marked an important milestone with regulatory guidance on the Phase 3 path for CAD-1005 and a late-breaking Phase 2 presentation at ISTH showing an absolute reduction of more than 25% in thrombotic events. The company is pursuing a capital-efficient model focused on strategic out-licensing, portfolio monetization, and commercial co-development rather than independently funding large late-stage clinical trials. It is also seeking multiple nondilutive grants to advance its programs. Cadrenal believes its pipeline addresses critical unmet needs and is structured to demonstrate value to prospective partners across the cardiac surgery continuum.