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8-K2026-05-07· grok-4-1-fast-non-reasoning

CVKD · Cadrenal Therapeutics, Inc. Common Stock

0001213900-26-053075

SEC filing

Summary

Cadrenal Therapeutics reported Q1 2026 financial results with reduced operating expenses and net loss, alongside FDA guidance enabling direct advancement to pivotal Phase 3 trial for CAD-1005 in HIT.

Key takeaways

Full analysis

Cadrenal Therapeutics reported significantly lower operating expenses in Q1 2026 compared to the prior year, driven by reductions in both R&D ($0.8 million vs. $1.7 million) and G&A ($1.7 million vs. $2.3 million), resulting in total operating expenses of $2.5 million and a net loss of $2.5 million, or $(1.04) per share, improved from $3.8 million, or $(2.09) per share, in Q1 2025. This reflects disciplined cost management amid advancing its lead program. Cash stood at $2.3 million at quarter-end, bolstered by a $2.5 million financing on April 1, 2026, to fund near-term activities, though the company is pursuing additional financing for the planned Phase 3 trial. The filing's core investor value lies in the FDA End-of-Phase 2 meeting minutes, providing clear guidance on the pivotal Phase 3 design for CAD-1005 in HIT, including protocol, study population, dosing, background therapy, safety database, and primary endpoint of centrally adjudicated new or worsening thrombotic events in SRA-confirmed patients. Phase 2 data demonstrated over 25% absolute reduction in thrombotic events when added to standard anticoagulation, supporting direct progression to this first-ever randomized, blinded, placebo-controlled registration trial in ~120 patients worldwide, with an interim analysis and projected 2029 NDA. CEO Quang X. Pham emphasized the defined registration path, positioning CAD-1005 as a potential first-in-class 12-LOX inhibitor and first new HIT therapy in over two decades, backed by Orphan Drug and Fast Track designations.