As we head into 2025, Volition is at a pivotal juncture, ready to revolutionize the diagnosis and monitoring of life-altering diseases for both animals and humans. This past year has seen significant milestones, including expanding access to the Nu.Q® Vet Cancer Test across 20 countries, establishing clinical utility for our Nu.Q® Cancer and Nu.Q® NETs tests, and forging strategic discussions to commercialize our groundbreaking epigenetic portfolio.
There is significant interest in potential out-licensing and/or supply agreements for both Nu.Q® NETs and our oncology portfolio, with several commercial discussions progressing well, and we are aiming to sign multiple human licensing deals in 2025. We also anticipate adding a number of clinical papers to our licensing data rooms early in 2025.
Our team’s dedication remains steadfast; driving progress across all our pillars, fostering clinical collaborations, achieving revenue growth and working to license our technologies. With a solid foundation, a focus on financial sustainability, and a clear vision for 2025, we are committed to fulfilling our mission of improving health outcomes for humans and animals worldwide.
Given that 2024 was a challenging year, I’m so proud of and thankful to our whole team for their hard work and support throughout.
Here are our 2024 key highlights with a brief look ahead to 2025:
Financing strategy
Our aim is to ensure that Volition is cash flow neutral in 2025, through a combination of revenues, licensing payments and grant funding and we made significant progress towards this target during 2024.
We have significantly reduced operating expenses whilst ensuring we deliver on our key priorities:
- growing revenue from Nu.Q® Vet through our global supply agreements, and initiating discussions with partners to enable the supply of an automated version of the Nu.Q® Vet Cancer Test in centralized labs.
- delivering the clinical data necessary to advance discussions towards securing several licensing agreements in the human health space in 2025.
Lastly, throughout our history, we have successfully secured non-dilutive funding on favorable terms from agencies in the Walloon Region of Belgium. We received additional funding for our R&D activities in 2024 and expect to secure further funding in 2025. We are immensely grateful for their ongoing support as we move into the next stage of our journey.
Governance and financing
In April, Martin Faulkes announced his retirement from Volition after serving as Executive Chairman since the company’s inception. Known as ‘Dill’, Martin played a crucial role in establishing Volition in 2010 and was instrumental in shaping our company strategy and leading the board of directors. We thank Dill for his leadership through our journey. We also extend our gratitude to Guy Innes, who served as our Interim Non-Executive Chair over the summer and continues to be an active member of the Volition board.
In September, we welcomed Dr Ethel Rubin as an independent director. With over 20 years of experience in the life sciences sector, Ethel has successfully launched commercial products and driven collaborations and strategic initiatives. Her expertise makes her ideally positioned to support us as we commercialize our epigenetic solutions.
In November, we were delighted to announce the appointment of Timothy Still as our new Chairman. Tim has extensive experience in the diagnostic sector and a proven track record of successfully guiding companies from the research and development phase to market readiness, ultimately driving commercial success. We look forward to benefiting from his strategic advice and leadership.
Scaling up Nu.Q® Vet Cancer Test
Expanding access to the Nu.Q® Vet Cancer Test is one of Volition’s primary objectives. We want to ensure veterinarians worldwide can benefit from canine cancer screening, earlier cancer detection, and improved outcomes for dogs in their care. We are realizing this aim through our supply agreements with industry organizations such as Heska (an Antech company, and part of Mars Science & Diagnostics), FujiFilm Vet Systems, IDEXX and others.
In April, Antech announced that their in-clinic version of the Nu.Q® Canine Cancer Test was available to veterinarians in the U.S. and Europe – operating on the Element i+® Analyzer – and providing veterinarians with a rapid, accurate, and cost-effective cancer screening tool at the patient side, with results within minutes.
Since then, Antech also rolled out our test in Canada, Australia, New Zealand, the UK, and several countries in Asia with further expansion across their global network planned.
In July, FujiFilm Vet Systems in Japan launched our test nationwide and has achieved significant market penetration, with nearly 10% of veterinarians ordering the Nu.Q® Vet Cancer Test.
During the same month, Vetlab, a leading veterinary laboratory in Poland, also introduced our test and is actively promoting it to its client base.
As a result of our market expansion activity, we are delighted that the Nu.Q® Vet Cancer Test is now available to veterinarians in 20 countries. We sold over 110,000 tests in the first three quarters of 2024, a 100% increase in revenue versus the same period in 2023.
Licensing our oncology and sepsis portfolio
As we work to commercialize our technologies in the human space, namely Nu.Q® NETs in the sepsis field and Nu.Q® Cancer and Capture-PCR™ in oncology, we are leveraging the valuable insights gained from our licensing and supply negotiations for Nu.Q® Vet (to-date we have received licensing-related payments of $23 million). Our near-term focus is to secure out-licensing deals in the human clinical space and our goal is to maximize the monetization of our intellectual property through up-front and milestone payments, and ongoing license revenues.
In addition, we are also seeking to license out our Nu.Q® NETs test, which detects diseases associated with NETosis such as sepsis, and we are undertaking direct negotiations with several key industry players in the diagnostic space.
It is clear that there is significant interest in potential licensing and/or supply agreements for both Nu.Q® NETs and our oncology portfolio.
Advancing our Nu.Q® NETs and Nu.Q® Cancer pillars by demonstrating clinical utility
I am immensely proud of the progress we achieved in innovation, science, and clinical development in 2024, in both our Nu.Q® NETs and Nu.Q® Cancer pillars. While not all of this progress can be publicly reported at this time, we have significantly enhanced our out-licensing data rooms.
Nu.Q® Cancer
For Nu.Q® Cancer, we aim to develop a low-cost, routine test to help detect disease early, guide tailored treatment, assess response to treatment, identify Minimal Residual Disease, and support continued treatment decisions.
In September, colleagues from Hospices Civils de Lyon presented a poster at the European Society of Clinical Oncology (ESMO) on the potential role of Nu.Q® Cancer in lung cancer monitoring to predict overall survival, indicate early progression risk and identify patients who may benefit from immunotherapy.
The Lyon team is currently conducting several studies and analyses utilizing our nucleosome quantification technology across various cancers and stages of the disease, from diagnosis and treatment response to the detection of minimal residual disease and monitoring for recurrence. It is an honor to work with Professors Payen, You, Duruisseaux, Couraud, Walter, Kepenekian and their whole team, and we look forward to collaborating further with them in 2025.
As 2024 came to a close, we were excited to announce the results of a large-scale study led by Professor Jin-Shing Chen and his team at National Taiwan University Hospital. The study demonstrated that the Nu.Q® Cancer Test could be utilized in lung cancer screening to differentiate between malignant and benign pulmonary nodules identified by Low Dose Computed Tomography (LDCT) scans in patients suspected of having lung cancer.
Lung cancer is a leading cause of cancer-related deaths worldwide. (LDCT is considered to be the gold standard for lung cancer screening and has significantly contributed to reducing mortality among high-risk patients. However, LDCT is highly sensitive, which can lead to a substantial number of false positives and cases of over-diagnosis.
Professor Chen’s research findings suggest that the Nu.Q® Cancer blood test could support physicians with clinical decision-making following LDCT. It could enable them to identify the patients at highest risk and whose nodules are more likely to be cancerous, while potentially identifying patients who present with a low risk of lung cancer for follow-up, to avoid unnecessary biopsy.
Professor Chen’s team has subsequently initiated a prospective validation study involving 500 patients at the National Taiwan University Hospital and the National Taiwan University Hospital Cancer Centre. This study is due to be completed later in 2025 and could potentially result in the inclusion of the Nu.Q® Cancer test in Taiwan’s National Lung Cancer Screening Program.
Nu.Q® NETs
In September, we hosted a Key Opinion Leader roundtable in Paris, which brought together experts in sepsis from across the globe to share research findings and consider how our Nu.Q® NETs test could be introduced in clinical practice.
Nu.Q® NETs is a simple, low-cost, accessible test to detect diseases associated with NETosis. Although NETs play a critical role in our normal immune response, elevated levels of NETs can lead to tissue damage and, in severe cases, sepsis, organ failure, and death.
Our roundtable event was chaired by Professor Djillali Annane, a Professor of Medicine at the University of Paris Saclay-UVSQ. The roundtable was pivotal in shaping our inaugural satellite symposium entitled ‘NETs: Casting a New Light on Sepsis Management,’ which took place at ESICM 2024, the world’s largest intensive care conference, in October.
The symposium explored research findings from three large, independent studies carried out at centers of excellence in France, Germany, and the Netherlands, involving more than 3,000 sepsis patients. All three clinical studies used Volition’s Nu.Q® NETs test to measure levels of circulating H3.1 nucleosomes in the bloodstream, a surrogate marker for Neutrophil Extracellular Traps (NETs).
Findings of these studies, summarized in our symposium report, consistently show that an elevated level of circulating H3.1 nucleosomes in sepsis patients reflects a dysregulated immune response and is associated with an increased risk of mortality, renal failure, respiratory failure, multi-organ failure, and septic shock.
The report concludes that Nu.Q® NETs could be used to predict patients at greater risk of deteriorating from sepsis.
Our satellite symposium Chair, Professor Annane, noted that using the Nu.Q® NETs test to measure elevated H3.1 nucleosome levels as a “treatable trait” in sepsis management could be a game changer in modifying a patient’s trajectory, lead to new ways of treating sepsis and improve patient survival and the quality of life of survivors.
Safe Harbor Statement
Statements in this Business Review 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, Volition’s expectations related to the launch of product sales with Heska and other counterparties to agreements, the success of negotiations and the timing, completion and execution of term sheets and/or agreements with third parties regarding the licensing and distribution of Volition’s products, the timing, completion, success and delivery of data from clinical studies, the potential uses, benefits and effectiveness of its Nucleosomics™ technology platform, including the Nu.Q® NETs test and the Nu.Q® Vet Cancer Test, and the timing and execution of Volition’s strategy with the FDA. 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, a failure by the marketplace to accept Volition’s Nu.Q® NETs test, Nu.Q® Vet Cancer Test or other products based on its Nucleosomics™ platform; Volition’s failure to secure adequate intellectual property protection; Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products; Volition will face fierce competition and its intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring markets and their 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. 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. Forward-looking 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 Business Review, 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™ 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 Business Review are the property of their respective owners.
