PONTE VEDRA, Fla. — May 7, 2026 — Leads & Copy — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) reported its financial results for the first quarter ended March 31, 2026, and provided a corporate update highlighting continued progress in its CAD-1005 program for HIT.
The company has received the official minutes from its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), which provided guidance on key elements of the planned pivotal Phase 3 registration trial for CAD-1005, Cadrenal’s investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor being developed to treat suspected heparin-induced thrombocytopenia (HIT).
Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT, based on feedback and Phase 2 data.
According to Quang X. Pham, Chairman & CEO, the company believes the registration path for CAD-1005 in HIT is clearly defined now that it has the official EOP2 meeting minutes. Pham added that the FDA’s guidance on trial design and the primary endpoint of new or worsening thrombotic events reinforces their confidence in advancing directly to a pivotal Phase 3 study, and that the company believes CAD-1005 has the potential to be the first new therapy for HIT in more than two decades.
The planned pivotal Phase 3 study will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029. It is the first randomized, blinded, placebo-controlled registration trial in HIT.
The primary endpoint, centrally adjudicated, is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis.
Phase 2 data showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy.
The company continues to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that targets the underlying immune drivers of HIT, supported by Orphan Drug and Fast Track designations from the FDA and by orphan drug status from the European Medicines Agency.
For the quarter ended March 31, 2026, research and development expenses were $0.8 million compared to $1.7 million for the same period in 2025. General and administrative expenses were $1.7 million compared to $2.3 million for the same period in 2025. Total operating expenses were $2.5 million compared to $3.9 million for the same period in 2025. Cadrenal reported a net loss of $2.5 million, compared to $3.8 million for the same period in 2025.
As of March 31, 2026, Cadrenal had cash and cash equivalents of $2.3 million. Subsequent to quarter end, on April 1, 2026, the company completed a $2.5 million financing, providing additional capital to support near-term development activities.
The company continues to evaluate financing and strategic alternatives to support its planned clinical development activities, including the anticipated pivotal Phase 3 trial of CAD-1005 in HIT.
The company is advancing Phase 3 readiness activities, including protocol finalization, and expects to provide further updates in the coming quarters.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor being developed to treat heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.
The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.
Source: Cadrenal Therapeutics, Inc.
