CSL Enters Strategic Collaboration with VarmX for VMX-C001

CSL Limited has entered into an agreement with Dutch biotech company, VarmX, to support the development of its lead asset, VMX-C001, a novel treatment to help restore blood coagulation in patients requiring urgent surgery or experiencing severe bleeding while on FXa DOACs. CSL has also entered into an exclusive option agreement with VarmX shareholders to acquire all issued and outstanding shares of the company.

Under the terms of the strategic collaboration agreement, CSL will fully fund VarmX’s global Phase 3 EquilibriX-S trial evaluating VMX-C001 in patients taking FXa DOACs who require urgent surgery. CSL will also fully fund and support VarmX in late-stage product development, manufacturing and pre-launch commercial and medical affairs activities.

Option to Acquire VarmX

CSL will make an upfront payment to VarmX shareholders of $117 million upon closing of the transaction for an exclusive option to acquire the company. CSL will have the right to exercise the option upon Phase 3 data. Subject to the achievement of certain milestones, following the exercise of the option and customary regulatory clearances, VarmX shareholders will receive a further $388 million in acquisition and additional payments up to the commercial launch of VMX-C001 and up to $1.7 billion in sales-based success milestones thereafter.

John Glasspool, Chief Executive Officer of VarmX, said: “The collaboration with CSL represents a transformative step for VarmX. By securing full funding for the registrational trial, product development, CMC and pre-launch activities, we are well positioned to bring VMX-C001 to patients. We are proud to partner with CSL, whose expertise and global reach will be invaluable as we move forward.”

Dr. Paul McKenzie, Chief Executive Officer of CSL, said: “We are excited to partner with VarmX to develop a novel treatment and address a significant unmet need aligning strongly with our strategic ambition to deliver enduring patient impact. It also aligns with our portfolio of medicines designed to minimize bleeding, preserve a patient’s own blood supply, improve surgical and medical outcomes and support global public health approaches to patient blood management.”

VMX-C001 was recently granted Fast Track Designation by the FDA, as announced on 3 September 2025, recognizing its potential to address a critical unmet medical need in restoring coagulation for patients on FXa DOACs requiring urgent surgery. Commercial launch is anticipated in 2029.