Cayuga Biotech to present first Phase 1 data for CAY001 at ASH 2026

Cayuga Biotech will present initial results from the first-in-human Phase 1 study of CAY001 at the 68th American Society of Hematology Annual Meeting in New Orleans on Dec. 14, 2026. The update matters because CAY001 is being developed as an acute treatment for life-threatening hemorrhage, a major unmet medical need.

Why it matters: - CAY001 is being developed as an acute treatment for life-threatening hemorrhage, a condition linked to nearly 2 million deaths each year. - The Phase 1 readout is the first clinical data for Cayuga Biotech's polyP-based approach in humans. - The presentation could help validate whether the program can move toward broader development for bleeding care.

What happened: - Cayuga Biotech said initial results from its first-in-human Phase 1 study of CAY001 in healthy volunteers will be presented at the 68th American Society of Hematology Annual Meeting. - The meeting runs Dec. 12-15, 2026, in New Orleans. - The presentation is scheduled for Monday, Dec. 14, 2026, from 6:00 to 8:00 p.m. Central at the Ernest N. Morial Convention Center, Hall F. - The presentation title is: CAY001, a novel synthetic short-chain polyphosphate–silica nanoparticle complex, shows favorable safety and dose-dependent pro-hemostatic activity in a first-in-human Phase 1a study. - The publication number is 4788. - The session is 321.Coagulation and Fibrinolysis: Basic and Translational.

The details: - CAY001 is an investigational single-dose intravenous treatment designed to accelerate clotting at the site of bleeding. - The program mimics the activity of endogenous platelet polyphosphate, or polyP. - Cayuga Biotech says the product has shown preclinical potential as a universal hemostatic drug. - Preclinical models showed rapid stopping of life-threatening bleeding and performance in difficult coagulation conditions. - Cayuga Biotech's pipeline also includes CAY002, a discovery-stage program for inherited bleeding disorders, plus additional early-stage programs across the healing continuum. - The company identifies bleeding as the first of many therapeutic applications for its proprietary polyP platform. - More information is available in the company's announcement. - The work is sponsored by the Defense Health Agency, Combat Casualty Care Portfolio, through the Medical Technology Enterprise Consortium under Other Transaction Number W81XWH-15-9-0001. - More information on MTEC is available at the consortium's website.

Between the lines: - The ASH presentation gives Cayuga Biotech a key early-stage forum to show whether CAY001's safety and pro-hemostatic effects translate from preclinical work into humans. - The company is positioning polyP-based therapeutics as a broader platform, not just a single-product bet. - The military-linked sponsorship underscores interest in therapies for severe bleeding, including trauma and combat-care use cases.

What's next: - Investors, clinicians and researchers will watch the ASH presentation for the first human safety and activity signals from CAY001. - Any stronger-than-expected dose-response or safety profile could support the next development steps for the program. - Cayuga Biotech is continuing work on CAY001 as a candidate for major hemorrhage and on earlier-stage follow-on programs.