Cadrenal Therapeutics Advances CAD-1005 to Phase 3 Following FDA End-of-Phase 2 Meeting for HIT Indication

Receipt of official FDA End-of-Phase 2 meeting minutes has locked in the registration pathway for Cadrenal Therapeutics' CAD-1005, a first-in-class 12-lipoxygenase inhibitor targeting heparin-induced thrombocytopenia (HIT), and the protocol parameters now on record will drive CMC planning, safety database sizing, and NDA preparation timelines for the next three years.

The EOP2 minutes cover protocol design, study population, dosing, background therapy, exposure requirements, safety database scope, and the primary endpoint: centrally adjudicated incidence of new or worsening thrombotic events in Serotonin Release Assay (SRA)-confirmed HIT patients. That level of specificity from FDA at this stage reduces late-cycle protocol amendment risk, a material consideration for a sponsor operating with a lean balance sheet.

Cadrenal will proceed to a randomized, blinded, placebo-controlled Phase 3 study enrolling approximately 120 patients across global clinical centers, with at least one planned interim analysis. The design is notable as the first registration trial of its kind in HIT. Phase 2 data underpinning the advance showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulation, the efficacy signal FDA reviewed in granting EOP2 alignment. CAD-1005 carries both Orphan Drug and Fast Track designations from FDA, as well as orphan drug status from the European Medicines Agency, designations that carry procedural and rolling-review implications for regulatory affairs teams tracking the NDA build toward a projected 2029 submission.

For manufacturing and CMC leads at contract development and manufacturing organizations engaged or being evaluated for this program, the 2029 NDA horizon sets a firm backward-planning window. Safety database requirements confirmed at EOP2 will inform batch production schedules, comparability protocols, and the process validation scope needed to support a 21 CFR Part 211-compliant submission package.

The financial picture warrants attention in that context. R&D spend fell to $0.8 million in Q1 2026 from $1.7 million in Q1 2025, with total operating expenses declining to $2.5 million from $3.9 million. Cash on hand stood at $2.3 million as of March 31, 2026; a $2.5 million financing closed April 1, 2026. Cadrenal has stated it continues to evaluate financing and strategic alternatives to support planned clinical activities, a signal that partnership or licensing discussions may intersect with Phase 3 site activation timelines.

The projected NDA submission in 2029 now represents the measurable checkpoint against which Cadrenal's Phase 3 execution, CMC readiness, and capital position will be assessed.

Source: Cadrenal Therapeutics, Inc. via GlobeNewswire, May 7, 2026.