- Trial Phase
- Phase 2 completed; pivotal Phase 3 planned (FDA End-of-Phase 2 meeting concluded)
- Time to Market
- Phase 3 not yet started; company projects NDA submission in 2029, implying potential approval no earlier than ~2030 if the pivotal trial succeeds.
- Why 4/10
- No hard, dated binary (PDUFA or pivotal readout) is scheduled within the next ~12 months — the pivotal Phase 3 trial for CAD-1005 in HIT is planned but not yet started, and the company projects an NDA submission in 2029 — so the score is capped at 5; a 4 reflects a mid-stage lead asset at a ~$6M micro-cap whose next meaningful news (Phase 3 initiation, partnering deal) is undated and non-regulatory.
Watch for (1) the start/enrollment of the planned 120-patient pivotal Phase 3 trial in HIT, (2) any outcome of the announced partnering process to out-license or co-develop CAD-1005, and (3) financing news — year-end cash of ~$4M was flagged as insufficient to fund Phase 3, and a July 2026 $3M placement already diluted shareholders by ~33%, so another raise is likely before any 2029 NDA. The stock trades near its 52-week low (~$1.66 vs a $14.64 high), and the only near-term analyst action on record is an HC Wainwright Buy maintain; treat the analyst mean target of $14 as far-dated optionality, not a near-term signal.
Price Chart
Executive Summary
CAD-1005 is Cadrenal Therapeutics' (CVKD, Nasdaq, ~$1.66/share, ~$6M market cap) lead drug: an oral 12-LOX inhibitor being developed for heparin-induced thrombocytopenia (HIT), a rare, life-threatening clotting complication of heparin with no HIT-specific FDA-approved drug. It holds FDA Fast Track and Orphan Drug designations, posted Phase 2 data with a >25% absolute reduction in thrombotic events, and the FDA's End-of-Phase 2 meeting green-lit a pivotal Phase 3 path with an NDA submission projected for 2029. The company has no revenue, ~$4M cash (year-end 2025) that management said may not fund Phase 3, and just did a ~33%-dilutive $3M placement — it has also launched a partnering process to out-license or co-develop CAD-1005 (alongside tecarfarin and frunexian).
How It Works
CAD-1005 is an experimental oral pill that blocks an enzyme called 12-LOX (12-lipoxygenase). In HIT — a dangerous immune reaction to the blood thinner heparin where the body attacks platelets and forms life-threatening clots — blocking 12-LOX is meant to dampen the abnormal platelet/clot cascade and prevent thrombotic events while heparin is being removed. Because the mechanism is anti-inflammatory, the company is also exploring it in metabolic disease.
Trial Status
Positive Phase 2 data in heparin-induced thrombocytopenia (HIT) showed a >25% absolute reduction in thrombotic events and were presented at ISTH 2026. FDA End-of-Phase 2 meeting minutes (received spring 2026) define a path to a planned 120-patient, randomized, placebo-controlled pivotal Phase 3 — described as the first of its kind in HIT — with an NDA submission projected for 2029. Preclinical data (March 2026) also suggest potential metabolic benefit in obesity/Type 2 diabetes, an exploratory expansion beyond HIT.
The Two-Sided Case
Upcoming Catalysts
- Initiation/registration of the planned 120-patient pivotal Phase 3 trial in HIT (no firm date disclosed)
- Any outcome of the formal partnering process to out-license, monetize, or co-develop CAD-1005 (frunexian and tecarfarin are also in the process)
- Additional equity or strategic financing (cash was flagged as insufficient for Phase 3)
- Quarterly results and cash-runway updates (next earnings releases)
- Any FDA interaction or designation news for CAD-1005 (e.g., Rare Pediatric Disease Designation was pursued for tecarfarin, not CAD-1005)
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Cadrenal Therapeutics, Inc. 8-K CVKD ·Originating report