1. CSL to fully fund VMX-C001 Phase 3 trial and development. 2. CSL has an option to acquire VarmX based on Phase 3 outcomes. 3. VarmX expects up to $2.1 billion in potential payments. 4. VMX-C001 addresses a significant unmet medical need in urgent care. 5. Commercial launch of VMX-C001 anticipated by 2029.
CSL's partnership with VarmX enhances its pipeline, similar to past successful collaborations that drove share prices higher.
The collaboration could significantly enhance CSL's market position in treating urgent bleeding, as no current solutions exist.
The ongoing Phase 3 trial and future commercialization of VMX-C001 can positively affect CSLLY's long-term growth.
VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has entered into a strategic collaboration with global biotechnology leader, CSL (ASX:CSL), to support the development of its lead asset, VMX-C001. VMX-C001 is 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.
CSL will make an upfront payment to VarmX shareholders of USD 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 USD 388 million in acquisition and additional payments up to the commercial launch of VMX-C001 and up to USD 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, commented:
"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."
Bill Mezzanotte, CSL Executive Vice President and Head of Research & Development, added:
"CSL was particularly interested in VMX-C001's unique mechanism of action, how it specifically targets Factor Xa inhibitors, compared to the more general action of other treatments, and the preclinical and early clinical data which led to U.S Food and Drug Administration (FDA) approval to proceed straight to a single Phase 3 study."
VMX-C001 is an investigational, recombinant modified Factor X protein administered as a rapid single-dose, effectively bypassing the FXa anticoagulation activity and swiftly restoring coagulation in patients on Factor Xa inhibitors in urgent surgery and severe bleeding situations. It could offer the potential to be used with all FXa DOACs and be administered with other common anticoagulants like heparin, and potentially, with no additional thrombotic risk.
By 2030, an estimated 30 million patients in the US, Europe, and Japan will be on Factor Xa (FXa) direct oral anticoagulants (DOACs) for chronic indications such as stroke prevention in atrial fibrillation and treatment of deep vein thrombosis. While these therapies are highly effective, 2-4% of patients each year face severe, life-threatening bleeding or require emergency surgery, amounting to more than 30,000 affected patients every week.
Despite the unmet clinical need, no fully approved therapeutic agent is currently available in the E.U. or the U.S. for treating acute major bleeding in patients on Factor Xa inhibitors.
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.
John Glasspool, Chief Executive Officer of VarmX concluded:
"We are grateful for the continued support of our investors, including Sound Bioventures, EIC, EQT Life Sciences, INKEF, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures, InnovationQuarter, LEH and UNIIQ, who share our vision of transforming urgent care for patients and have been instrumental in helping the company grow and reach this milestone."
UBS AG is acting as the exclusive financial advisor to VarmX. NautaDutilh N.V. is acting as legal advisor to VarmX.
Notes to Editors
About VarmX
VarmX is a spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX's lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter. For more information, please visit www.varmx.com.
About VMX-C001
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.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 crucially, no additional thrombotic risk.
About CSL
CSL ((ASX:CSL, OTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL, visit www.CSL.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250915030511/en/
For further information, please contact:
Vigo Consulting (media enquiries)
Rozi Morris
+44 20 7390 0230
VarmX@vigoconsulting.com