VarmX, a Netherlands-based biotech company, announced on Tuesday that it has entered into a strategic collaboration with Australian biotechnology company CSL Limited (ASX:CSL) (USOTC:CSLLY) to advance the development of its lead asset, VMX-C001.

The investigational therapy is designed to restore blood coagulation in patients on Factor Xa direct oral anticoagulants (FXa DOACs) who require urgent surgery or face severe bleeding.

Under the agreement, CSL will fully fund VarmX's global Phase 3 EquilibriX-S trial, as well as late-stage development, manufacturing, and pre-launch activities. VarmX shareholders will receive an upfront payment of USD117m and may earn additional milestone payments of up to USD2.1bn, including sales-based success milestones.

CSL also secured an exclusive option to acquire all issued and outstanding shares of VarmX, exercisable upon positive Phase 3 results and regulatory clearances. The arrangement positions VarmX to accelerate the path to market for VMX-C001, with commercial launch anticipated in 2029.

VMX-C001, a recombinant modified Factor X protein, is administered as a rapid single-dose treatment that bypasses FXa anticoagulation activity and restores coagulation. The therapy has received FDA Fast Track Designation and could address a significant unmet need, as no fully approved treatment currently exists in the United States or Europe for acute major bleeding in patients on FXa inhibitors.