Volition Signs First Human Out Licensing Deal

Rhea-AI Summary

VolitionRx (NYSE AMERICAN: VNRX) has signed its first human out-licensing deal - a Research License and Exclusive Commercial Option Rights Agreement with Werfen's Immunoassay Technology Center for Antiphospholipid Syndrome (APS) applications.

The agreement grants Werfen access to Volition's proprietary Nu.Q® H3.1 NETs assay components to investigate its clinical utility in APS patient management. Werfen has successfully transferred the Nu.Q® NETs assay to their ACL AcuStar® platform, with early results showing promise in detecting NETs levels in APS patients.

APS affects approximately 4 million people worldwide, causing increased blood clot risks and pregnancy complications. The Nu.Q® NETs test represents the first CE-IVD biomarker being investigated for APS, potentially offering improved diagnostic information and ongoing patient monitoring capabilities.

Positive

• First human out-licensing deal for Volition's Nu.Q® NETs technology
• Successful technology transfer to Werfen's ACL AcuStar® platform already completed
• Early results in detecting NETs levels in APS patients described as encouraging
• Potential to improve diagnosis and monitoring for 4 million APS patients worldwide
• First CE-IVD biomarker being investigated for APS application

Negative

• Financial terms of the agreement not disclosed
• Commercial launch dependent on successful clinical utility validation
• Agreement currently limited to research phase with commercial option rights

Insights

Biotech Licensing Expert

Volition's first human out-licensing deal with Werfen for Nu.Q® NETs testing in APS represents significant commercial validation and revenue potential.

This licensing agreement marks a pivotal strategic milestone for Volition, representing their first human out-licensing deal for their proprietary Nu.Q® NETs technology. The partnership with Werfen—a global leader in specialized diagnostics with established market presence in hemostasis and thrombosis—provides Volition with access to Werfen's technical capabilities, regulatory expertise, and installed base of analyzers.

The deal structure is noteworthy: it begins as a research license with exclusive commercial option rights specifically for Antiphospholipid Syndrome (APS), which affects approximately four million patients worldwide who require lifelong monitoring. This creates substantial recurring revenue potential if commercialized successfully.

Technically, the collaboration has already achieved important validation milestones. Werfen has successfully transferred the Nu.Q® NETs assay to their ACL AcuStar® platform, and early detection results in APS patients are described as "encouraging." The next phase involves clinical utility studies to determine the marker's potential as a thrombosis risk indicator in APS management.

What's particularly valuable is that Volition's Nu.Q® NETs test could potentially be the first CE-IVD biomarker investigated specifically for APS. If successful, this could position their technology as a first-mover in improving APS diagnostics, personalizing care, and providing a cost-effective monitoring solution throughout patients' lifetimes.

While financial terms remain confidential, this partnership represents Volition's execution of their broader commercial strategy to out-license their proprietary technology to established industry players, potentially generating significant licensing revenues while leveraging partners' disease expertise and market access.

HENDERSON, Nev., Sept. 9, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces the signing of a Research License and Exclusive Commercial Option Rights Agreement for Antiphospholipid Syndrome ("APS") with Werfen's Immunoassay Technology Center, a worldwide leader in specialized diagnostics. Full terms of the agreement are confidential.

Commenting on the agreement, Mr. Gael Forterre, Chief Commercial Officer, Volition said:

"We are proud to have entered into this agreement with Werfen, as we implement our strategy to out license our proprietary Nu.Q® NETs test to large worldwide companies to leverage their knowledge of specific diseases, product development, regulatory experience and their installed base of proprietary analyzers. Werfen is a global leader in the field of in vitro diagnostics for hemostasis and thrombosis, among others, where Neutrophil Extracellular Traps ("NETS") play such an important role.

"Under this agreement Werfen will gain access to the components of Volition's proprietary Nu.Q® H3.1 NETs assay and will investigate its clinical utility in the management of APS patients on its platforms. Werfen also has an option to negotiate terms with Volition for it to launch the product commercially under an exclusive license.

"It is an exciting next step in our ongoing collaboration; as we have previously developed a good relationship working on the technology transfer and are very much looking forward to this next phase."

Marta Palicio, Werfen's Immunoassay Technology Center Innovation R&D Director, commented:

"We have already successfully transferred the Nu.Q® NETs assay to our ACL AcuStar® platform. Early results in NETs levels detection in  APS patients with the Nu.Q® test are encouraging. We are excited to validate further and complete a clinical utility study to determine the potential role of this marker as a risk indicator of thrombosis in APS patients, allowing a better management of this very complex syndrome. This could open the possibility to enlarge Werfen's portfolio in APS testing."

Mr. Remi Rabeuf, Vice President Corporate Alliances & Strategic Partnerships, Volition added:

"APS is a complex disorder of the autoimmune system affecting around four million people worldwide. It causes an increased risk of blood clots and their associated complications, such as stroke, heart attack, pulmonary embolism or deep vein thrombosis. It is also associated with recurrent miscarriages and pregnancy complications.

"It is currently diagnosed through a panel of blood tests, requiring two positive results at least 12 weeks apart and is often a life-long condition requiring regular monitoring.

"Emerging evidence suggests increased NET formation appears to be a central mechanism in thrombosis in APS and that targeting NET-pathways could provide future therapeutic avenues for thrombotic complications¹.

"We believe that Volition's Nu.Q® NETs test is the first CE-IVD biomarker being investigated in APS and could provide not only improved diagnostic information to aid clinical decision-making and personalize care, but also a low-cost test to continue to monitor these patients throughout their lifetimes.

"It is exciting to achieve this major milestone with Werfen and we look forward to a fruitful long-term collaboration together."

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1. Ayesha Butt, Anish Sharda, Alfred Ian Lee, Jason S Knight, Analytical Review: Neutrophil Extracellular Traps and Antiphospholipid syndrome, Transfusion Medicine Reviews, 2025,
   https://doi.org/10.1016/j.tmrv.2025.150909

About Antiphospholipid Syndrome

Antiphospholipid syndrome (APS) is a disorder of the immune system that causes an increased risk of blood clots.

In APS, the immune system produces abnormal antibodies that make the blood "stickier" than normal. This means people with APS are more likely to develop blood clots in their veins and arteries, which can cause serious or life-threatening health problems such as stroke, heart attack, pulmonary embolism or deep vein thrombosis. It is also associated with recurrent miscarriages and pregnancy complications.

To diagnose APS, the blood needs to be tested for the abnormal antiphospholipid antibodies. This currently requires a blood test specifically designed to look for these antibodies. A diagnosis of APS can only be made if a patient has consistent symptoms and after two abnormal blood test results, with a minimum 12-week gap between them. There are approximately four million people diagnosed with APS globally.

Most people with APS need to take anticoagulants or antiplatelet medication daily for the rest of their life.

About Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. It is a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.

Werfen operates directly in 30 countries and in more than 100 territories through distributors. It is headquartered in Barcelona, Spain and has Technology Centers located in the United States and Europe. Worldwide sales in 2024 were €2.2 billion.

About Volition

Volition is a multi-national company focused on advancing the science of epigenetics. Volition is dedicated to saving lives and improving outcomes for people and animals with life-altering diseases through earlier detection, as well as disease and treatment monitoring.

Through its subsidiaries, Volition is developing and commercializing simple, easy to use, cost-effective blood tests to help detect and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early detection and monitoring have the potential not only to prolong the life of patients, but also to improve their quality of life.

Volition's research and development activities are centered in Belgium, with an innovation laboratory and office in the U.S. and an office in London.  

The contents found at Volition's website address are not incorporated by reference into this document and should not be considered part of this document. Such website address is included in this document as an inactive textual reference only.

Media Enquiries:

Louise Batchelor, Volition, mediarelations@volition.com +44 (0)7557 774620

Investor Relations:

Jeremy Feffer, LifeSci Advisors, jfeffer@lifesciadvisors.com +1-212-915-2568

Safe Harbor Statement

Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to, among other topics, the total addressable market for Nu.Q® Discover, , Volition's expectations related to revenue opportunities and growth, the timing, completion, success and delivery of data from clinical studies, the effectiveness and availability of Volition's blood-based diagnostic, prognostic and disease monitoring tests, Volition's ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases as well as serving as a diagnostic, prognostic or disease monitoring tools for such diseases, and Volition's success in securing licensing, distribution and/or other agreements with third parties for its products. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including, without limitation, results of studies testing the efficacy of its tests. For instance, if Volition fails to develop and commercialize diagnostic, prognostic or disease monitoring products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition's failure to obtain necessary regulatory clearances or approvals to distribute and market future products; a failure by the marketplace to accept the products in Volition's development pipeline or any other diagnostic, prognostic or disease monitoring products Volition might develop; Volition's failure to secure adequate intellectual property protection; Volition will face fierce competition and Volition's intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring market and its rapid technological change; downturns in domestic and foreign economies; and other risks, including those identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics™, Capture-PCR™, Capture-Seq™ and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners.  Additionally, unless otherwise specified, all references to "$" refer to the legal currency of the United States of America.

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SOURCE VolitionRx Limited

FAQ

What is the new licensing deal between VolitionRx (VNRX) and Werfen?

VolitionRx has signed a Research License and Exclusive Commercial Option Rights Agreement with Werfen for its Nu.Q® NETs assay in Antiphospholipid Syndrome (APS) applications. The deal allows Werfen to investigate the clinical utility of Volition's technology on their platforms.

How many people could benefit from VolitionRx's APS diagnostic technology?

The technology could potentially benefit approximately 4 million people worldwide who are affected by Antiphospholipid Syndrome (APS), a complex autoimmune disorder that increases blood clot risks.

What is the current status of VolitionRx's Nu.Q® NETs test for APS?

The Nu.Q® NETs test is the first CE-IVD biomarker being investigated for APS. Werfen has already successfully transferred the assay to their ACL AcuStar® platform with encouraging early results in detecting NETs levels in APS patients.

What are the potential advantages of VolitionRx's Nu.Q® NETs test for APS patients?

The test could provide improved diagnostic information for clinical decision-making, enable personalized care, and offer a low-cost monitoring solution for lifetime patient management.

What is the significance of this deal for VolitionRx (VNRX)?

This represents VolitionRx's first human out-licensing deal and demonstrates their strategy to partner with large worldwide companies to leverage their disease expertise, product development capabilities, and regulatory experience.