VolitionRX Limited: Outlines broad strategy to become the 'NETs company' worldwide through licensing and updates progress of Nu.Q® NETs test adoption

, /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces that Chief Commercial Officer, Gael Forterre, has issued a commercial update on Volition's Nu.Q® NETs product. A Message from our Chief Commercial Officer As was stated in our shareholder update recently, 2025 is a pivotal year for Volition as we focus on commercializing our groundbreaking Nu.Q® platform in the human diagnostics market. Today, I would like to focus on the large, and very broad Nu.Q® NETs (NETosis) opportunity. Our efforts on this are two-pronged: 1. Licensing To negotiate with large multi-national companies to launch our Nu.Q® NETs test on their extensive base of installed machines already servicing every hospital in the world, with existing labs and sales teams. The focus of these discussions is centered around significant unmet needs in sepsis and coagulation. The aim, as we successfully achieved in the vet space, is to operate a low CapEx / low OpEx model; Low CapEx for our partners in that they already have a global footprint of their automated systems and low OpEx for Volition as the majority of functions (sales, regulatory and clinical affairs, sales, marketing) are conducted by our partners. Volition simply provides access to its intellectual property and the supply of key components for the test itself. We believe this is a win-win for everyone, allowing broad adoption worldwide with limited investment and giving these large companies a new revenue stream from their installed base. I am delighted to report we are in confidential discussions regarding the licensing and supply of our Nu.Q® NETs assay with seven international companies. Notably, the combined market value of six of these companies is just under $600billion1, underscoring the significant global strength, potential reach and impact our technology could achieve through such partnerships. We are making significant headway in the commercialization of Nu.Q® NETs. Licensing discussions are progressing well with several potential licensing companies having already successfully completed the tech transfer of our assay onto their platform(s). Our goal is to secure multiple licensing agreements in the human diagnostics space, mirroring our successful strategy in the veterinary market, with diverse deal structures, all with ongoing revenue and some to include large milestone payments. Volition's technology has already been successfully transferred and run on several other companies' analyzers. Our strong clinical evidence supports the use of our Nu.Q® NETs technology in a critical area, sepsis. The Total Addressable Market for the testing and monitoring of Intensive Care Patients alone represents a $1 billion opportunity annually2, offering substantial revenue opportunities for Volition and our future partners. We believe, as I will discuss shortly, that the Total Addressable Market for our Nu.Q® NETs assay could be in excess of $10 billion annually2, as the use cases expand far beyond sepsis. 2. Leverage existing CE-marked Nu.Q® NETs test The second prong of our strategy is to leverage our granted CE mark, approved in the EU for any NETs related diseases. As a reminder, Volition's chemiluminescent immunoassay (ChLIA) version of the CE-marked Nu.Q® NETs Test is via the IDS-i10™ automated analyzer platform from Immunodiagnostic Systems, a subsidiary of Revvity. I would like to thank Immunodiagnostic Systems for their collaborative approach. Our aim is to sell this product, either directly or in conjunction with Immunodiagnostic Systems, to institutions for use in the very wide range of clinical applications where NETosis plays a critical role. In a significant commercial milestone, we recorded our first revenue from sales of our CE-Marked Nu.Q® NETs automated product in Europe in Q1 2025. This is the first revenue generated from a regulated clinically approved product. Nine hospital networks in five countries have placed orders and are currently assessing its clinical utility in a range of NETs applications (see table below) with the intention, we believe, of integrating it directly into their routine patient care. In addition, we are in discussions with a further twelve hospital networks, with at least nine evaluations anticipated to start in the second half of 2025. In short, a number of groups are buying our CE marked product with the view to using it clinically in a diverse range of NETs-related uses. We are delighted with the level and breadth of interest that we have seen in the past six months and we continue to receive more inbound enquiries. The range of potential clinical use cases where NETosis plays a role is extremely broad, equating to a mix of potential market sizes (from small to very large); there is clearly wide unmet clinical needs driving these evaluations. NETs are a key part of a broad range of clinical conditions, and our aim is to become the "NETs company" worldwide, by partnering with the very best companies, hospital networks and governments. The level interest in using our Nu.Q® NETs test is notable: clinical use cases include coagulation, cardiac issues, renal disease, trauma, burns, auto immune diseases, organ transplant, pregnancy management and of course the biggest being Sepsis. We expect, through this second prong that our Nu.Q® NETs test will start to be used in routine clinical practice with patients next year in the EU and then expanded to use worldwide through the expected global licensing agreements of the first prong to our strategy. This is a great outcome for Volition; they buy kits, generating not only revenue but also clinical data for a wide range of use cases. We look forward to updating you in the exciting months ahead. Clinical Applications Under Evaluation by Centers of Excellence in Europe with Nu.Q® NETs CE-marked test Sepsis patient management Treatment monitoring of sepsis patients (EMBRACE trial NCT06694701) Sepsis associated Acute Kidney Injury prediction Follow-up of discharged patients from ICU Burns Distinction between SIRS and sepsis patients Cardiac disease x 2 centers Cardiopathy post surgery patient management Acute brain injury Anaphylactic shock during anesthesia Lung post-transplant patient management Autoimmune diseases such as Systemic Lupus Erythematosus, Rheumatoid Arthritis NETosis in synovial fluid for Rheumatoid Arthritis Potential Clinical Applications in Discussion Burns Distinction between SIRS and sepsis patients Sepsis patient management x 6 centers Pediatric sepsis management Pregnancy management x2 centers Inflammatory conditions Combined stock market valuation as of 15th April 2025, data on file Data on file, Volition Total Addressable Market Model 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, [email protected] +44 (0)7557 774620 Investor Relations:Jeremy Feffer, LifeSci Advisors, [email protected] +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 exercise of the milestone-linked warrants upon the achievement of such milestone events or otherwise prior to their expiration, Volition's expectations related to revenue opportunities and growth, the timing, completion, success and delivery of data from clinical studies, the timing of publications, the effectiveness of Volition's cost reduction measures, 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 and/or distribution 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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VolitionRX Limited: Outlines broad strategy to become the 'NETs company' worldwide through licensing and updates progress of Nu.Q® NETs test adoption

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