Cadrenal Therapeutics Presents Late-Breaking Phase 2 Data at ISTH 2026, Showing Greater Than 25% Reduction in HIT Thrombotic Events

Cadrenal Therapeutics, Inc. (NASDAQ: CVKD), a late-stage biopharmaceutical company developing therapies for life-threatening immune and thrombotic conditions, presented late-breaking Phase 2 data for CAD-1005 at the ISTH 2026 Congress in Paris on July 13, 2026. Selected as one of only three late-breaking abstracts in the clinical trials and innovation in thrombosis session—the largest ISTH meeting in more than a decade—the data showed an absolute reduction of more than 25% in thrombotic events in patients with heparin-induced thrombocytopenia (HIT). The FDA has already provided Phase 3 guidance following an April 2026 End-of-Phase 2 meeting, making CAD-1005 Phase 3-ready.

HIT Represents a Life-Threatening Condition With No Approved Root-Cause Therapy

Heparin-induced thrombocytopenia is a severe immune-mediated reaction to heparin, the most widely used parenteral anticoagulant in hospitalized patients. Rather than preventing clots, HIT triggers paradoxical platelet activation and hypercoagulation that can cause life-threatening arterial and venous thromboses. Existing therapies switch patients to alternative anticoagulants but do nothing to address the underlying immune mechanism driving the disorder. CAD-1005 selectively inhibits 12-lipoxygenase (12-LOX), an enzyme that sits at the center of the immune signaling cascade responsible for platelet activation in HIT. By targeting 12-LOX, CAD-1005 attacks the root cause rather than managing downstream consequences—and it does so without replacing the existing anticoagulant, making it a potential add-on therapy for patients already receiving standard of care. Cadrenal estimates peak annual revenue of approximately $2 billion for the indication.

Phase 2 Data Establish the First Controlled Evidence Base in HIT

The Phase 2 trial is the first-ever randomized, blinded, placebo-controlled study in HIT—a striking gap given the severity of the condition. Principal Investigator Dr. Steven E. McKenzie of Thomas Jefferson University delivered the oral presentation at ISTH. The placebo group recorded a high rate of thrombotic events exceeding 75%, while the CAD-1005 group held that rate to approximately 50%—an absolute reduction greater than 25 percentage points. The trial did not meet its pre-specified primary endpoint of platelet count recovery rate, a surrogate chosen by the prior IND sponsor that Cadrenal considers poorly suited to the biology of HIT. The thrombotic event reduction, a key secondary endpoint, drives the clinical advancement case and directly informed the FDA’s April 2026 Phase 3 guidance, which aligned on new or worsening thrombotic events as the primary endpoint for the pivotal trial.

Regulatory Designations and Phase 3 Readiness

CAD-1005 holds FDA Orphan Drug and Fast Track designations and orphan drug status from the European Medicines Agency—a combination that accelerates both review timelines and potential market exclusivity. The April 2026 EOP2 meeting gave Cadrenal FDA guidance on protocol design, study population, dosing, background therapy, exposure requirements, and the safety database needed for approval. That guidance package effectively hands the company a regulatory blueprint for the pivotal trial. In parallel, Cadrenal expanded its 12-LOX platform in early 2026 with the acquisition of oral 12-LOX inhibitor candidates targeting chronic inflammatory indications, extending the pipeline beyond the acute HIT setting and broadening the long-term commercial opportunity of the platform.

Strategic Investment Summary

• ISTH Presentation: Cadrenal Therapeutics (NASDAQ: CVKD) presented late-breaking Phase 2 CAD-1005 data at the ISTH 2026 Congress in Paris on July 13, selected as one of three late-breaking oral presentations at the largest ISTH meeting in over a decade.
• Efficacy Signal: CAD-1005 delivered a greater than 25% absolute reduction in thrombotic events versus placebo when added to standard anticoagulant therapy in HIT patients, with placebo event rates exceeding 75%.
• First-in-Class Mechanism: CAD-1005 selectively inhibits 12-LOX, targeting the root immune signaling mechanism that drives platelet activation in HIT—the only 12-LOX inhibitor in clinical development worldwide.
• Phase 3 Blueprint in Hand: The April 2026 FDA EOP2 meeting delivered guidance on protocol design, study population, dosing, and primary endpoint (new or worsening thrombotic events), making CAD-1005 Phase 3-ready.
• Regulatory Designations: CAD-1005 holds FDA Orphan Drug and Fast Track designations alongside EMA orphan drug status, supporting accelerated review and extended market exclusivity upon approval.
• Market Opportunity: Cadrenal estimates approximately $2 billion in peak annual revenue for CAD-1005 in HIT, a market with no currently approved therapy addressing the root immune cause of the disorder.

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