• VarmX and Rentschler Biopharma expand collaboration from early development to late‑stage and commercial manufacturing of VMX-C001

   

• VMX‑C001 builds on strong regulatory momentum, including FDA Fast Track Designation and PMDA Phase 1 waiver, as it progresses toward a global Phase 3 trial

   

• Manufacturing will be transferred from Rentschler Biopharma site in Laupheim (Germany) to Milford, MA (USA)

Rentschler Biopharma began supporting early development of VMX-C001 in 2022 at its Laupheim, Germany site and VarmX has since initiated its Phase 3 program using GMP material from Rentschler Biopharma. Building on the successful collaboration between both companies, all subsequent Phase 3 clinical supply, including process validation, will be manufactured at Rentschler Biopharma’s Milford, MA site as part of the seamless transition into late-stage clinical and commercial production. The CDMO brings strong expertise in producing a variety of biologics, including proven capabilities in intensified, perfusion-based processes, while also supporting fed-batch strategies. Rentschler Biopharma provides clients with continuity, speed and reliability from early development through commercialization and beyond.

VMX-C001 is a modified, human factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade. The product candidate was granted Fast Track Designation by the U.S. Food & Drug Administration (FDA) and a Phase 1 waiver from Japanese regulator PMDA in September 2025, recognizing the unmet need for treatments that can rapidly restore coagulation in patients receivingFXa DOACs. VarmX signed a global strategic collaboration and option agreement with CSL in September 2025. VarmX plans to initiate its global Phase 3 EquilibriX-S trial in urgent surgery in early 2026.

John Glasspool, Chief Executive Officer of VarmX, said: “Manufacturing readiness is key as we prepare to commence our landmark global EquilibriX-S Phase 3 trial, evaluating the ability of VMX-C001 to rapidly restore coagulation in patients taking any FXa DOAC undergoing urgent surgery. We’re pleased to extend our partnership with Rentschler Biopharma as we drive VMX-C001 towards becoming a new treatment option for the substantial number of patients on FXa DOACs who need emergency surgery.”

Benedikt von Braunmühl, Chief Executive Officer of Rentschler Biopharma, commented: “We are honored to continue our collaboration with VarmX, which reflects exactly what Rentschler Biopharma stands for: high‑impact technical expertise, long‑term partnership grounded in trust, and tailored solutions that bring breakthrough therapies to patients. As VMX‑C001 advances toward Phase 3, we remain fully committed to delivering seamless continuity, leveraging our FDA‑licensed sites in the EU and the U.S. and deep experience in late‑stage development and market approval. Guided by our vision of advancing medicine to save lives – together, we look forward to supporting VarmX on the path to commercialization.”

By 2030, approximately 30 million patients in the U.S., Europe and Japan are expected to receive FXa DOACs as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, more than 30,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge¹.

VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with common anticoagulants like heparin, and no additional thrombotic risk. This strengthens the position of VMX-C001 to potentially become a new option for the substantial number of patients on FXa DOACs who need emergency surgery.

1: RBC and Cowen (2018–2024), Syneos Health Consulting (incl. Japan), and clinical literature