VarmX, a biotech company specializing in treatments for patients on direct oral anticoagulants targeting activated factor Xa (FXa DOACs), has entered a strategic collaboration with global biotech leader CSL to advance its lead product, VMX-C001. The investigational therapy aims to restore blood coagulation in patients requiring urgent surgery or facing severe bleeding while on FXa DOACs.
As part of the agreement, CSL will fully fund VarmX’s global Phase 3 EquilibriX-S trial, focusing on patients taking FXa DOACs who require emergency surgery. CSL will also support late-stage product development, manufacturing, and pre-launch commercial and medical affairs activities.
CSL has secured an exclusive option agreement to acquire all outstanding shares of VarmX. The deal includes an upfront payment of USD 117 million upon closing, with the option exercisable following Phase 3 trial results. Upon exercising the option and meeting milestones, VarmX shareholders could receive up to USD 388 million in acquisition payments and additional sums up to USD 1.7 billion tied to commercial success.
John Glasspool, CEO of VarmX, called the collaboration a “transformative step” that secures full funding to bring VMX-C001 to patients globally. CSL’s CEO, Dr. Paul McKenzie, highlighted the partnership’s alignment with the company’s mission to improve patient outcomes by addressing significant unmet medical needs.
VMX-C001 is a recombinant modified Factor X protein designed for rapid single-dose administration. It works by bypassing the anticoagulant effect of FXa inhibitors, swiftly restoring coagulation without added thrombotic risk. The treatment has potential applications across all FXa DOACs and may be used alongside other anticoagulants such as heparin.
With an estimated 30 million patients projected to be on FXa DOACs by 2030 in the US, Europe, and Japan, the need for effective treatments for acute bleeding or emergency surgery in these patients is critical. Currently, no fully approved therapies exist in the US or EU for this purpose.
VMX-C001 recently received FDA Fast Track Designation, underscoring its promise in addressing this urgent clinical need. Commercial launch is anticipated in 2029.
VarmX expressed gratitude toward its investors, including Sound Bioventures, EQT Life Sciences, and others, for their ongoing support.
UBS AG and NautaDutilh N.V. are serving as financial and legal advisors to VarmX, respectively.