VarmX partners with CSL in a strategic collaboration and option agreement to develop novel investigational coagulation treatment

More than 600.000 people in the Netherlands use so-called DOAC blood thinners to prevent life-threatening blood clotting events. In emergency surgery and severe bleeding situations, blood clotting should be restored immediately. While current treatments are limited, the VarmX candidate medicine VMX-C001 could change that.

VarmX is a UNIIQ company from day one.

In 2016, UNIIQ was the first investor in VarmX. At that stage, the technology was still in proof of concept and commercial success was uncertain. Together with the founders, UNIIQ helped shape the company, structure the early phase and prepare VarmX for future investment rounds. Since 2017, InnovationQuarter Capital has backed the company through multiple growth rounds, helping it scale from Leiden-based startup to global medtech innovator.

Today’s partnership with CSL shows what early-stage validation can lead to.

VarmX announced it has entered a strategic collaboration with CSL to support the company’s development of VMX-C001. CSL has also entered into an exclusive option agreement with VarmX shareholders to acquire all issued and outstanding shares of the company. VMX-C001 is a novel treatment to help restore blood coagulation in patients requiring urgent surgery or experiencing severe bleeding while on Factor Xa direct oral anticoagulants (FXa DOACs).

Under the terms of the strategic collaboration agreement, CSL will fully fund VarmX’s global Phase 3 trial evaluating VMX-C001 in patients taking FXa DOACs who require urgent surgery (EquilibriX-S). 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 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 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.

“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.”

– John Glasspool, Chief Executive Officer of VarmX.

“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.”

– Dr. Paul McKenzie, CSL’s Chief Executive Officer.

“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.”

– Bill Mezzanotte, CSL’s Executive Vice President and Head of Research & Development.

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 published 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.

The treatment could be launched as early as the 2029 financial year.

This milestone is the result of long-term public-private support

VarmX is grateful for the continued support of its investors, including Sound Bioventures, EIC, EQT Life Sciences, INKEF, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures, InnovationQuarter, LEH and UNIIQ,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.

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