VolitionRx Limited Full Fiscal Year 2025 Earnings Call - Clinical commercialization accelerates as NETs and Nu.Q Cancer move into real-world use and Capture-Seq shows >99% pure ctDNA

Operator: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Full Fiscal Year 2025 Earnings Call. During today’s presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be opened for questions. If you have a question, please press the star key followed by the number one on your touch tone phone. If you would like to withdraw your question, please press the star key followed by the number two. If you’re using speaker equipment, please lift the handset before making your selections. This conference call is being recorded today, April 1, 2026. I would now like to turn the call over to Louise Batchelor, Group Chief Marketing & Communications Officer. Please go ahead.

Louise Batchelor, Group Chief Marketing & Communications Officer, VolitionRx Limited: Thank you, and welcome everyone to today’s earnings conference call for VolitionRx Limited. Before we begin, I’d like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties, and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance, or achievements expressed or implied by these statements.

We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call. Cameron Reynolds, Group Chief Executive Officer, will open the call, providing a summary of key achievements in 2025. Terig Hughes, Chief Financial Officer, will then provide a financial report before handing over to Doctors Retter and Micallef, who will present research highlights from across our product pillars. Cameron will close with a discussion of upcoming milestones. We will then open the conference call to a question and answer session. With that, I’ll turn the call over to Cameron.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thanks, Lou, and thank you everyone for joining Volition’s full fiscal 2025 earnings call today. As always, we very much appreciate your time, given the busy earnings call season. Before diving into detail, I would like to take a moment to reflect on our founding mission. We set off over 15 years ago to help save lives and improve outcomes for millions of patients worldwide, and I could not be prouder of the progress we have been making towards that goal. In the fourth quarter of 2025, we not only received our first order for the Nu.Q Cancer assays for clinical certification ahead of routine clinical use in lung cancer, but we also announced the inclusion of our Nu.Q NETs assay in real-world interventional evaluation of early detection of sepsis in a government-backed, approximately $7.3 million program in France.

Our tests are about to be used in both these devastating diseases to help save lives in the real world hospital settings. An extremely proud moment for our entire team. Cancer and sepsis are leading causes of death, accounting for approximately a third of deaths worldwide. With the first clinical use now imminent, we’re about to be part of the solution through simple, easy-to-use, low-cost tests. I believe we will look back on 2025, this first quarter of 2026, and in time, the next few quarters, as transformational for the company. In 2025, efforts for Volition focused on commercializing our groundbreaking Nu.Q platform in the human diagnostic market. We’re excited to start the implementation of our human licensing strategy with the signing of not one, but two agreements. The first with Antiphospholipid Syndrome, APS, with Werfen, and a co-marketing services agreement with Hologic.

Both are multi-billion dollar companies and worldwide leaders in their specialized field, and we are delighted to be working with them. We have further strengthened our intellectual property portfolio and are continuing our licensing discussions with around 10 of the world’s leading diagnostic and liquid biopsy companies. These discussions are at various stages of negotiation process across all our different pillars, and we anticipate announcing additional agreements throughout 2026. Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vet market. We anticipate diverse deal structures with potential for upfront and milestone payments and future recurring revenue. We have developed a truly remarkable, versatile platform and are working with governments and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide as quickly as possible.

Beyond licensing, we also achieved several significant commercial milestones in 2025. In the first quarter, we recorded our first revenue from sales of our CE Mark Nu.Q NETs automated assay, a regulated, clinically approved product. NETs, or more specifically, NETosis, goes far beyond just sepsis. It’s implicated in a very wide range of diseases. Currently, 12 hospital networks across a number of countries are evaluating our Nu.Q NETs assay across 15 different clinical use cases and indications. We believe NETs testing will become a key part of routine blood testing. In February 2025, we announced our first commercial sale of Volition’s proprietary high throughput NETs method that measures neutrophil extracellular traps, NETs activation and inhibition in whole blood in real time, helping companies develop new therapeutics to combat sepsis and other NETs-related disease.

In March, we signed an agreement with a leading pharmaceutical company to utilize Volition’s Nu.Q Discover biomarkers in a longitudinal phase I/IIb study, the first human clinical study with a pharmaceutical company sponsor that our test supports. Through our Nu.Q Discover pillar, we are now serving close to 100 clients worldwide, including many top pharma and diagnostic companies, accelerating disease research and drug development across multiple therapeutic areas. Some of these pharmaceutical companies are progressing to late-stage clinical trials using our assays as pharmacodynamic biomarkers. We estimate the total addressable market for relevant companion diagnostics to be a little under $1 billion. In 2025, we delivered substantial revenue growth for Nu.Q Discover, which Terig will detail, and we anticipate a similar trajectory in 2026.

The Nu.Q Vet Cancer Test is the number one canine cancer screening blood test in the world, now available in over 20 countries. To further accelerate revenue growth and ensure consistent delivery, we focused on central lab automation. In March 2025, Fujifilm Vet Systems extended their contract to implement a centralized automated platform for the Nu.Q Vet Cancer Test using IDS-i10 made by Revvity. Subsequent to year-end, in March of this year, we announced the completion of all validation and verification of the chemiluminescent immunoassay CLIA version of the Nu.Q Vet Cancer Test with Fujifilm Vet Systems in Japan, allowing use of full automation rather than manual plates in central labs. This is a world first and will significantly enhance turnaround times and throughput to meet increasing demand.

We believe that central lab automation is crucial for scaling of our vet business and integrating our test into routine pet wellness panels. Importantly, this automation platform is the same technology utilized for our human diagnostic products, Nu.Q Cancer, Nu.Q NETs, and Nu.Q Discover, highlighting the inherent synergy and efficiency of our core Nu.Q platform. From a product expansion perspective, we made great progress with our research in the use of Nu.Q NETs in cats. In May of 2025, we announced the publication of our first clinical paper reporting the detection of nucleosomes in cats. Subsequent to year-end, in early January of this year, we reported results from a clinical study demonstrating the high accuracy of its Nu.Q Vet feline assay in detection of lymphoma in cats, the most common cancer in the species.

At 100% specificity, meaning no false positives, the assay detected over 80% of feline lymphomas. This breakthrough marks the development of what we expect to be the world’s first simple, affordable, blood-based liquid biopsy test for feline cancer, a significant unmet need in veterinary medicine. This opens up the potential for cancer screening and monitoring in cats. There are more than 60 million cats in the U.S. alone, 25% of which are senior cats and therefore suitable for an annual check. This represents a tremendous commercial opportunity for Volition. The publication of this study in a peer-reviewed journal is expected subsequently to unlock a $5 million milestone contract payment. We will also generate ongoing revenue in this large and growing market where our technology meets an unmet need. Incredibly quick progress from a product development perspective and great to add a third species for Nu.Q.

I will return at the end of this call to discuss some additional recent achievements and upcoming milestones. Now we’ll pass over to Terig for a finance report.

Terig Hughes, Chief Financial Officer, VolitionRx Limited: Thanks very much, Cameron, and hello, everyone. I’m now delighted to provide a full fiscal year financial report for the year to December 31, 2025. From a revenue perspective, we finished the year strongly with year-on-year growth for Q4 of 133%. For the full year 2025, we recorded $1.7 million in revenue, a growth of 40% over the full year 2024. I’m delighted to report we received our first revenue from the CE Mark-marked Nu.Q NETs product in Europe during 2025. We also received our first order for Nu.Q Cancer from Lyon for the certification of our cancer test in their hospital network, more of which from Andy later in the call. As we have stated previously, at this early stage of commercialization, revenues remain fairly lumpy and difficult to predict from one quarter to the next.

While I remain confident of continuing to see solid growth year over year, we will not be providing revenue guidance for 2026 at this point in time. From an expenditure perspective, we significantly reduced operating expenses, which were $4.8 million lower, a reduction of 17% compared to the full year 2024. Indeed, looking at the trend over the last two years, we are now operating at significantly lower levels of expenditure. Furthermore, we will continue to take measures to reduce costs further over the coming year. Net cash used in operating activities was $19.7 million in 2025. This compared with $25.9 million in 2024. Cash and cash equivalents at the end of the year totaled approximately $1.1 million.

However, subsequent to year-end and through March 25, we received approximately $5.4 million in net proceeds from our at-the-market, or ATM, facility, and $1.9 million in net proceeds from issuance of a convertible note to Lind Global Asset Management XII LLC. We continue to receive significant support from agencies of the Walloon region in Belgium, and subsequent to year-end, we announced non-dilutive funding of approximately $2.3 million. This takes the non-dilutive funding support from all sources from inception to date to over $25 million. To summarize the finance report, key indicators are trending positively. Revenue was up 40% year-on-year. Operating expenses were down 17% on a full-year 2025 basis. Net cash used in operating activities was down 24% year-on-year. We continue to work on reducing our underlying operating expenses.

We expect to secure a $5 million milestone payment from our existing agreement in the vet space. Last but not least, licensing discussions are progressing well, and I look forward to providing updates as they progress. Throughout 2025, and indeed subsequent to year-end, we have made significant scientific and clinical progress. With that, I will hand over to Andy and Jake.

Dr. Andy Retter, Chief Medical Officer / Research Lead, VolitionRx Limited: Thank you, Terig, and hello everyone. I appreciate there is an incredible volume of information shared on these calls, so I will try and limit my comments to what I believe are recent important clinical achievements. I’ll start with Nu.Q NETs. NETosis is an area of increasing scientific interest with a significant number of research articles published in recent years. In February, a review article entitled The Net Effect: Neutrophil Extracellular Traps, A Potential Key Component of the Dysregulated Host Immune Response, was written by myself alongside two key opinion leaders in the sepsis arena, Professor Jean-Louis Teboul and Professor Mervyn Singer. This paper has already been accessed more than 11,000 times and cited in almost 60 peer-reviewed publications. From a clinical utility perspective, we have published two key papers. The first was with the team from Amsterdam UMC, looking at more than 1,700 critically ill patients.

That paper is available free to download from Critical Care. The second paper, available on medRxiv, written with our colleagues in Jena, is another independent study looking at 971 patients with sepsis. Together, the data from these studies show that Nu.Q H3.1 accurately distinguishes sepsis from non-infectious systemic inflammation. It is strongly correlated with disease severity and provides excellent prognostic information for outcomes such as organ failure, specifically renal failure, and mortality. The prognostic power of H3.1 measured at ICU admission significantly exceeded existing severity scores such as APACHE II and the SOFA score.

As a result of this convincing evidence, in December, we were delighted to announce the inclusion of our Nu.Q NETs test as the sole biomarker in the DETECSEPS study, a real-world evaluation using H3.1 in combination with the National Early Warning Score to promote the early detection of sepsis and try and promote the flow of patients through emergency rooms. This is a problem every healthcare system in the world faces. Not only is DETECSEPS led by prominent clinicians, it is also backed with financing from the French government. DETECSEPS aligns with Volition’s core purpose of operationalizing our understanding of epigenetics, and in particular of H3.1 in clinical practice, to help identify and monitor the severity of disease.

The DETECSEPS program provides an opportunity to receive individualized care, adjusted to the risk of deterioration or risk of progression to multiple organ failure. It is a great privilege to be involved in such a program, and we hope that through earlier identification and risk stratification of patients, many lives can be saved. We also hope that by improving the flow of patients out of emergency rooms, that we can help hospitals run more efficiently, sending people home safely, escalating and expediting care to those patients who need it most. These efficiency gains could be huge and have a real impact on the entire running of hospitals and improve the delivery of healthcare. I think you can understand why we say it has an impact in all healthcare settings.

A final exciting development in 2025 has the potential to be a game-changing technology, not only in disease where time is critical, such as sepsis, but also in providing our tests to lower-income countries where laboratory infrastructure may be weak or non-existent. Specifically, this is the development of a lateral flow test for point-of-care quantification of nucleosomes. In July 2025, we reported the quantification of nucleosomes in whole blood in minutes utilizing a simple lateral flow device. I’m delighted to say the second phase of research is now well underway, with the first patient recruited for comparison between whole blood and capillary blood in critically ill patients. This really is a technology to look out for in the coming months. Hot off the press, we are delighted to announce this week the publication of a study with our colleagues at the Mayo Clinic in the journal Shock.

The Mayo Clinic study of 674 trauma patients demonstrated that nucleosome levels as measured by Volition’s Nu.Q H3.1 and Nu.Q H3R8 Citrulline tests are elevated in people that go on to have complications from trauma. The identification of reliable biomarkers in trauma is a clinical challenge and remains a significant unmet need in the emergency and surgical settings. Professor Park, the principal investigator and senior author of the paper, said, "These biomarkers could aid in early risk identification and may inform targeted preventive strategies in trauma care." For my part, I believe this is a significant study not only for clinicians, patients, and their families, but also for Volition. A peer-reviewed publication with the Mayo Clinic research team strongly supports our efforts to commercialize our Nu.Q NETs products.

Indeed, my overall sentiment is that this study, together with our previously published evidence, demonstrates that Nu.Q NETs may enable clinicians and researchers to anticipate disease, guide treatment decisions, understand disease trajectory, and monitor patients ahead of time across acute and chronic conditions. Turning to Nu.Q Cancer and in particular lung cancer, where the first clinical use of Nu.Q is now imminent, Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment, selection, and monitoring. Research conducted by our long-term collaborators in Taiwan and Lyon consistently demonstrates that our Nu.Q Cancer technology empowers clinicians to make informed treatment decisions and provides valuable new monitoring capabilities through the patient journey. From a publications perspective, the first NTU manuscript was published in March 2025, coincidentally almost the same day as the first patient was enrolled in their validation study.

The NTU team also presented data at the North American Lung Cancer Conference in Chicago in December, and then as recently as last week’s ESMO’s European Lung Cancer Congress. Both posters support the use of Nu.Q Cancer preoperatively to help identify patients at high risk. High H3K27me3 nucleosome levels predicted poorer recurrence-free and overall survival outcome. Whereas a lower H3K27me3 level indicated a significantly better outcome. Joint lead author Dr. Chen commented that, "The Nu.Q Cancer technology supports a practical approach to empower clinicians to make a more informed treatment decision and provides valuable new monitoring capabilities throughout the patient journey." This is excellent endorsement indeed, and I know from the commercial team that they are now looking forward to how we can provide the test in routine clinical practice.

Together with our colleagues in Lyon, we’ve also presented at a number of conferences and prepared a further two manuscripts for submission, peer review, and publication. The first of which has just been submitted, and the second is due to be submitted in the coming weeks. These results demonstrate that measured methylated nucleosome biomarkers at non-small cell lung cancer diagnosis can provide valuable information about survival, progression-free survival, and crucially help enhance the identification of patients who may benefit from more intensive therapy and potentially offer them curative care. As Cameron said at the top of the call, we made our first sale of our Nu.Q cancer assays to the Hospices Civils de Lyon, one of Europe’s leading cancer centers, and subsequent to year-end, we have announced with the support of our Lyon team, the preparation of our reimbursement submission to the French government.

Reimbursement is the next step on the path to the first use of Nu.Q in clinical practice, an exciting prospect which is core to Volition’s mission using our test to help save lives. Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q Cancer. Once achieved, we anticipate the introduction into routine clinical use in France by the fourth quarter of 2026. This is a truly exciting and rewarding prospect. With that, I will pass you over to Jake, who will give you an update on another significant project. Thank you, everyone. Over to you, Jake.

Dr. Jake Micallef, Chief Scientist, VolitionRx Limited: Thanks very much, Andy. Hello, everyone. I’m just going to be talking about one project today, Capture-Seq, which we’ve had several announcements about, the first in December and others in more recent weeks. Volition is, I believe, the first company to demonstrate the isolation and analysis of greater than 99% pure circulating tumor-derived DNA. To set the scene, the biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not from cancer cells. In a world-first new technology, Volition has overcome this hurdle and produced greater than 99% pure cancer-derived plasma DNA sequence sets for liquid biopsy. Our manuscript, submitted in November and previously announced in December 2025, described a new liquid biopsy chemistry for isolating ctDNA from plasma.

Subsequently, our continuing work on CTCF bound DNA has revealed what we believe to be an unprecedented new discovery, that there is almost no CTCF bound DNA in healthy plasma and almost all CTCF bound DNA in the blood of a cancer patient is derived from cancer cells, i.e., it is virtually pure circulating tumor-derived DNA. Removal of background normal cell-free DNA from the blood to reveal this level of tumor-derived DNA has been a long-term goal of liquid biopsy. In this updated manuscript, we report a new two-step method for preparing virtually pure circulating tumor DNA sets for cancer patients. The first step is the physical enrichment of the sample, and the second step is the bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set. This new method produced more than 99% pure ctDNA sequencing data sets for blood samples from cancer patients.

While we capture a subset of the circulating tumor DNA, not all of the circulating tumor DNA in a sample, it is virtually pure cancer DNA. These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers, representing, in my opinion, the biggest scientific breakthrough in cancer testing and monitoring in recent years. Last week, we released data from a blinded validation cohort of 81 subjects, including 59 colorectal and lung cancer patients and 22 healthy controls, and we were extremely encouraged by the results, particularly in early-stage cancer, where we detected more than 95% of stage 1 and stage 2 cancers. For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq could contribute to multi-cancer early detection, fulfilling a significant unmet clinical need.

We also believe Capture-Seq has the potential to play a role in cancer management, including, but not limited to minimal residual disease detection, including tumor-naive minimal residual disease detection and treatment monitoring, either alone or potentially in combination with other technologies. Volition is, I believe, the first liquid biopsy company to focus on circulating cell-free nuclear proteins, and we have filed a number of new patents to protect this technology. As you can imagine, this has generated a lot of interest, and we’re in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development and launch of this technology as soon as possible. With that, I’ll pass over to Cameron for his commercial perspective and wrap-up. Cameron.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thanks, Jake, and let me start by congratulating you, Andy, and the whole innovation, research and development, and the clinical teams on the truly amazing progress you have made, not only this year, but over the last 15 years. We set out to help save lives and improve outcomes for millions of patients worldwide, and we’re making huge progress towards that goal. With the first clinical use now imminent in both early sepsis detection and lung cancer management, we are about to be part of the solution through simple, easy-to-use, low-cost tests. Our vision is for our technologies to be incorporated into tests that will be used first by millions and ultimately hundreds of millions of people and animals a year. With our platform licensed to a range of large diagnostic and liquid biopsy companies and governments worldwide.

Combining our groundbreaking technology with their installed base of labs, analyzer machines, and sales forces around the world, we will achieve the optimal outcome for us. Large companies have the resources to realize the opportunities better than Volition. The total addressable market, TAMs, for our technologies on an annualized basis are multi-billion-dollar opportunities, not only for Volition, but for our licensing partners too. Volition has made strong progress both clinically and commercially. Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vet market, and anticipate, similar to the vet market, diverse deal structures with potential for upfront and milestone payments and recurring revenue. As mentioned earlier, we are continuing our discussions with around 10 of the world’s leading diagnostic and liquid biopsy companies.

These discussions are at various stages of the negotiation process across all our pillars. Our laser focus is on executing licensing agreements, and we will update you as they complete. Thank you for joining our call today. We very much appreciate it. We will now take your questions. Operator?

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Justin Walsh with JonesTrading. Please proceed.

Justin Walsh, Analyst, JonesTrading: Hi. Thanks for taking the question. As we see more from Capture-Seq, it would be great if you could provide some additional color on the current state of the liquid biopsy field, where maybe the field has seen some success and where alternative approaches have fallen short. Maybe related to this, some takeaways on the failure of the large NHS Galleri trial to achieve its primary endpoint.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah. We tend not to criticize the other companies. I mean, they’re often well-run companies with good people trying to do good things. I think it’s very fair to say our discussions with everyone, no one out there thinks their current testing modality is where they really need it to be in early-stage detection for multi-cancer detection or an MRD for treatment naive. That’s obviously not something either. There is 100% an opportunity for anyone who can develop something which is truly routine, which ours is, low cost and easy to use, which ours is, and it certainly appears to be very accurate. We’re doing more and more studies, but the early work is incredibly encouraging.

I think, you know, in any space like cancer detection, there’s going to be a number of parties. No company, no matter how good the technology will be everything. I think there’s a very strong case to be made, we will be a big part of cancer detection in the human space like we are in the vet space, starting with the fantastic lung work, which is in the process of being reimbursed, which is incredibly encouraging. Of course, the strong promise we have from Nu.Q Capture, which could either be used in conjunction with what’s currently used or potentially a test in itself. Given the early-stage detection that we’ve shown, that’s certainly a possibility.

Overall, I think, we’ve got something which is very special in what we do, and we’re working with a number of groups now. Obviously we can’t say who they are, it’s confidential, but we have a lot of active discussions going. These are things which are far bigger than we can commercialize ourselves. The bigger companies certainly have the installed capacity or the knowledge in particular areas like screening and MRD. We’ll be updating as those hopefully come to fruition, hopefully in the more near term, and we’re expecting a lot of news on that through the year. As far as individual ones go, I guess you can read the news. There’s been a lot of things which have not turned out exactly how they wanted.

You know, we always say we will succeed if we deliver a good platform. We haven’t spent a lot of time concerned about everybody else. There’s always gonna be a place for a routine, accurate, low-cost test, and that’s exactly what we think we’ve developed. We’re working hard on commercializing.

Dr. Andy Retter, Chief Medical Officer / Research Lead, VolitionRx Limited: Thanks for taking the question.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you, Justin.

Operator: Our next question is from Yi Chen with H.C. Wainwright. Please proceed.

Yi Chen, Analyst, H.C. Wainwright: Thank you for taking my questions. My first question is, could you comment on how do you expect the Nu.Q Cancer assays to ramp up in terms of volume throughout 2026? And my second question is, can you just provide some general comments on how many new licensing deals you expect to close this year? Thank you.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: I’ll start with the deals, and the first question I didn’t quite understand. Can you repeat the first question, please, Yi?

Yi Chen, Analyst, H.C. Wainwright: How do you expect the volume of Nu.Q Cancer assays to ramp up through 2026?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Okay. I’ll allow the CFO to answer that. I’ll deal with the deals. Look, it’s very hard to know. We’ve signed several in the human space already with fantastic companies. We’re working with three multi-billion-dollar companies in the human space now. Revvity has launched a CE Mark kit in Europe on its platform. Revvity, the PerkinElmer, obviously a very large company. They very much like what we do. We’re working with Hologic on the Discover side on the marketing, which is very exciting. We’re working with Werfen now on the NET kit and the process. If you look at each individual area, I think ultimately the NET test will be something that’s extremely widely used. The uses, as we’ve said, go way beyond the massive market of sepsis.

Just yesterday, I believe it was yesterday anyway, the past few days, we announced the Mayo Clinic results, which show if you’ve had trauma, a very elevated level. I mean, have a look at the numbers, it’s quite spectacular. Very elevated level if you’ve had trauma and even higher and I mean very, very high. You can go through the numbers again in the paper if you’ve had VTE. Trauma is one of the biggest, well, highest cause of death of people below 50 in the world and one of the major causes of admission to emergency. Another massive use for our NET test. Deal-wise, there’s all the NET tests. We’re talking to several companies now on the capture side, which is obviously very exciting.

The governments are working on the lung cancer monitoring side, as you know. It’s hard to say which of the 10 or so companies will be first and what the order will and how many there will be. I think I’d strongly suggest we will have multiple deals with different companies, different governments, this year. I think it’ll be across cancer and probably NET as well. We’re also working with groups on our recombinant nucleosomes and on Nu.Q Discover. Don’t forget, we do have 100 clients in Nu.Q Discover now, and some of those are coming to the stage where they’re gonna become quite large in process, where they come into clinical studies, where they become very serious amounts of revenue.

Overall, I can’t give you an exact number, but I’m sure I’m quite certain we’ll have deals, and we’re trying to get them out as quickly as possible because we basically stopped the R&D side, and we’re now on just commercialization because we have an absolute mountain of opportunities in all the pillars, and we’re very happy with how those deals are progressing. And the volume, Terry?

Terig Hughes, Chief Financial Officer, VolitionRx Limited: Yeah. I think as Cameron mentioned earlier, we’re in the process of the submission preparation for the reimbursement. Yeah, that’s obviously an H2 event in terms of approval of that. We’d expect it to be about Q4 by the time we get a reimbursed product into routine clinical use.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: We haven’t built a huge amount in this year given the timing, but we would expect it to ramp fairly quickly once it’s in routine clinical use. The Nu.Q NETs is now in IVDD, in the process of being IVDR. We’re recording some revenue for that, but at the moment, we’re not providing guidance to be conservative. Obviously, there’s a lot of things happening, and they’re all moving forward, but exactly when in the year it happens, obviously will greatly affect when they’ll contribute to recurring revenue. They’re all making progress, and they’ll all be coming on stream, we think, in the next few quarters.

Yi Chen, Analyst, H.C. Wainwright: Thank you.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you, Gabe.

Operator: Our next question is from Steven Ralston with Zacks. Please proceed.

Steven Ralston, Analyst, Zacks: Good morning or good evening, as the case may be.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Good morning.

Steven Ralston, Analyst, Zacks: I looked into the revenue streams that you expect from the different pillars going forward. It seems to be quite complex because there are different avenues in each area. The one in Nu.Q vet is developed and it’s basically dependent on the partners and how successful they are in their different geographic regions. Can you make a comment on the rate of acceptance of the vet test for canines among the different partners you have? Are there any commonalities of the more successful ones of how they’ve ramped up usage?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah. I think there’s several different partners there. I think between all of them, the one strong message we got. Obviously, our revenue is growing, but which in a normal company, 40% would be very good, but obviously, we’re looking for a lot more than that to really ramp. The key message from all of them, the key to that is to have it in a centralized lab. Currently, the vast majority of market, like over 80% of testing in dogs, is done through a centralized lab. The only option currently we have available in centralized labs up until a few weeks ago was microtiter plates, the plastic plates. Obviously that’s not great if you’re trying to do millions of tests.

A centralized hospital network, and there are several in the U.S. and foreign. You could get hundreds of thousands or millions of tests per network if it’s part of a wellness panel or what they call the index of individuality. We obviously have not cracked them yet. A key part of that is the acceptance, but also being able to run, you know, maybe potentially hundreds of thousands of tests per month. You’ve probably noticed, Fujifilm, who’ve been fantastic partners and very proactive, have shown it now works on the centralized lab. The fantastic Revvity machine, which we’re now using also for NETosis in Europe, the CE Mark machine, the same one. That’ll start flowing through.

It comes down to, you know, it’s lumpy between quarter and quarter and when they order a batch and when they don’t ’cause the plates can last up to a year. Obviously, Antech has also launched the small machine, but that’s also subject to them selling and getting those machines in lots of different places. That’s not gonna be an exponential growth by any means. It has come down to that. But don’t forget also we are now working on felines, which potentially, I don’t think will actually double the market, but theoretically it doubles the market ’cause there’s more cats than dogs in the world. That’s making good progress. Obviously, we’ve got Nu.Q Capture, which potentially has uses in all this as well.

There’s a lot of things going on in vet, and it’s very hard to predict once, you know, if and when a centralized lab system in the U.S. goes for the centralized machine. I think that’s something that could then accelerate very quickly. In the meantime, it’s kind of lumpy and bumping along at a, you know, the rates of growth you can see. It’s hard to tell. Our commercialization efforts in the last six months are very much focused on the human space. We’re extremely keen, you know, lung reimbursement. In Europe, that’s EUR 50 per test, so it’s a lot more per test as well. And if it’s a...

Once it’s approved, and we expect it to be by the end of this year, then obviously that’s a very good revenue source. The CE Mark kits are out there, so we spend a lot of effort changing from IVDD to IVDR, so it extends indefinitely from the time limits we currently have. Of course, we’ve put a lot of effort into licensing Nu.Q Capture. The vet has not been the focus of the company, but it’s obviously important to keep it ticking over. We have made progress in the cats and centralized labs, and we’re looking perhaps even for transcription factors in dogs and cats.

Steven Ralston, Analyst, Zacks: Now, you even went into an area that I wanted to ask you about next, is that, in Europe, you seem to have a very strong foothold with these hospital networks in the areas of sepsis and,

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yep.

Steven Ralston, Analyst, Zacks: lung cancer.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yep.

Steven Ralston, Analyst, Zacks: Is that a model for your global emphasis, or it just happens to be that this is the first foray?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: It’s a bit of everything. Ultimately, what we have in Europe is a fantastic large multinational company in Revvity, which is the old PerkinElmer, who have a machine which our test works on very well. They’ve undertaken to put it in lots of different locations. There’s over a dozen large hospital networks which are testing. Our CE Mark is any NETs-related inflammation, so that’s obviously a lot of different things. You’ve just seen the Mayo Clinic, that also involves trauma, and trauma is potentially as big as everything else. It’s quite remarkable how versatile it is.

As Volition, we don’t wanna be doing 10 studies in trauma, in sepsis, in COVID, in APS, in HLH, all those things. We’ve shifted a lot to our partners doing the work, like Werfen, for example, in inflammatory diseases, like all the companies doing it in the process. We are also looking for a large or several large diagnostic companies to, you know who large diagnostic companies are, to take it on. I think, as Andy said, the evidence is getting more and more overwhelming that NETs is gonna be a very large product. If you take all the issues in sepsis, all the issues in all the autoimmune diseases, add in trauma, and COVID, it’s just obviously huge. It’s been part of our strategy to get other people to buy our kits and do these studies.

The only issue, it just takes their own time, but we’re not spending. I think the big daddy of all those is the French government, which has spent $7 million-$8 million, whatever it is, on an interventional study to test and hopefully launch our product as the screening test in France in conjunction with NEWS, which are the physical symptoms, the non-biomarkers. Now, if that does go well, I think there’s a very good chance it will. We won’t know till the end, but we’ve seen it work very well in sepsis.

We will become the test in France, which I think then will become the test in Europe, and then it becomes extremely easy to license to a large international diagnostics to do a 510(k) in the U.S., to also launch there. Our strategy has been develop the platform, make sure it’s incredibly robust, reproducible, reliable, make sure it’s certified, which it is now on the first platform, get other people to do the work, and I think that’s been a tremendous success, and get them to do the legwork to show what the cutoff should be. It fits in with our global strategy, and now we’re working with the big diagnostic companies to get the first one of them to license on their large auto analyzer machines beyond the Revvity machine that we have now.

Does that answer your question, Steven?

Steven Ralston, Analyst, Zacks: Oh, yes, very much so. Thank you for taking my questions.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah. Just on a personal note, just to finish, I think it’s incredibly gratifying. I don’t know if everyone understands necessarily. An interventional study means it’s used on real people in real life, and those decisions are taken based on our test, and that’s gonna be this year when the study starts. That’s the confidence they have in the test. This is not a university exercise or someone doing some blood, you know, some samples from the freezer. It’s an interventional study, and I don’t quite know how much that would cost in the U.S. We didn’t get it costed, but it’s an awful lot more than the EUR 8 million I think the French government’s spending on it to do it, say, in the U.S.

Huge amount of very valuable work being done for us, and it shows a level of confidence in what we do. It’s very heartening for us as a team to have it being used on actually saving people’s lives this year.

Steven Ralston, Analyst, Zacks: Thank you.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you.

Operator: Our next question is from Bruce Jackson with The Benchmark Company. Please proceed.

Bruce Jackson, Analyst, The Benchmark Company: Hi. Thanks for taking my questions. I wanted to follow up on the Capture-Seq paper. It’s a fabulous study. I’m curious to know how amenable is this process to front-end automation in the lab, and how easily could it be integrated into, like, an MRD test or a liquid biopsy test in the lab?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Jake is here, our Chief Scientist, so that’s probably a Jake question. Jake.

Dr. Jake Micallef, Chief Scientist, VolitionRx Limited: Hello, Bruce. Thanks for the question. Yeah, very good question. Essentially, well, first of all, the updated revised version of the manuscript is live on Research Square now, so that’s public, and exactly how it works and how we’ve proved that we really have produced pure tumor DNA, all of that’s in the paper and publicly accessible to everybody. In terms of the question, the basic process involves two parts. The first part is a magnetic antibody, so it’s the same as an immunoassay. It’s the same as a Nu.Q immunoassay. The same as a PSA assay or a CEA assay. And the second part is sequencing.

All, you know, immunoassay is easy to automate, and the sequencing is actually much less involved than the sequencing that is involved in other tests because we’ve removed all the background. There’s actually less DNA to sequence, and of course, there’s less analysis in the end because most of the analysis is involved in trying to work out whether any of the DNA came from a cancer or not. But if you’ve removed everything that didn’t come from a DNA, that analysis also becomes like a PSA test. You know, it shouldn’t be there. If it is there, it came from the cancer. I think it’s at the moment what we do is manual, but it is extremely suitable to be automated.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Just some indications of cost, Bruce. People ask us this. It’s. We can answer that in a couple of ways. The capture side, which is, Jake said, the magnetic beads, the antibody, the immunoassay, at the moment may cost us $100, but that’s gonna come down, but not to $10 or $20, but you know, somewhere more like $60, $70, $80, something like that, to do the capture side. As Jake said, it depends on the sequencing. The sequencing really depends on what the panel looks like, how many markers you have, but you know, that could be a few hundred dollars or $500, depending on where we end up and how the panel looks. That’s sort of the cost you’re looking at for the test.

The sort of $80 is for the capture and then the sequencing. If it’s shallow sequencing or oxidizable sequencing and shallow sequencing, it won’t be a lot, but it. That’s really to be determined. That’s actually something our partners are looking at when we’re looking at licensing. Obviously, they’re the sequencing experts. It’s not a low cost test in the sense of ELISA that costs us $1 or $2 to make, but it has a strong potential to be tissue specific and very accurate. I think the market certainly would bear a few hundred dollars for that test, as we talked about, but that’s all in process. No, it’s incredibly encouraging and an amazing breakthrough for a small company to have managed to concentrate.

People say, "How did we do it? What made us able to do it?" We’re the experts of chromatin fragments, CTCF fragments. Everyone’s ignored the ultrashort DNA for a whole lot of reasons. The sequencing machines don’t tend to do much below 100. We’re experts at nucleosomes, and now we’re experts at transcription factor-bound DNA. We’ve really done something, 15 years of heartache and pain getting where we are. Has made us very good at chromatin fragments, and this is just another chromatin fragment. It is actually quite easy process. It’s a magnetic bead, an antibody, and sequencing.

Obviously, it’s a lot of sequence in there and a lot of work to get to where we are, but at its heart, it’s a very simple process which I think can be optimized a lot from where we are.

Bruce Jackson, Analyst, The Benchmark Company: Okay, great. Just a couple of quick finance questions. What’s the anticipated timing of the feline cancer milestone? I know the paper has to be published before you get the milestone, but would that be like a second quarter event, potentially third quarter?

Terig Hughes, Chief Financial Officer, VolitionRx Limited: It’s difficult to predict, but we do expect to collect that money this year. We are in the process of submitting that paper, which is the final step in completing the requirements for the milestone. We do expect to have that completed shortly. Like I said, it’s difficult to know exactly which quarter it’s going to fall into in terms of collecting that money, but we certainly expect to collect it this year.

Bruce Jackson, Analyst, The Benchmark Company: Okay. Last question for me on the operating expense profile for 2026. Would you expect that to be up, down, or about the same as 2025?

Terig Hughes, Chief Financial Officer, VolitionRx Limited: I think we’ve made a lot of progress over the last 18 months in terms of bringing the cost down. We’re now operating at a significantly lower burn rate than we were 18 months ago, for example. Nevertheless, we’re continuing with cost saving actions and, you know, we’re targeting to take out another 25%-30% from the cash OPEX this year. Now, that’s not all gonna happen in one fell swoop. That’s gonna take us, you know, through the end of the year to achieve that so that the exit run rate is that much lower. I think in terms of quarters, it’s a bit lumpy and difficult to predict, but I wouldn’t expect a sequential reduction in the first quarter.

First quarter is always a little bit heavier, and there are obviously some severance costs to take into account. I think I would expect, you know, going through the rest of the year to see the cash OPEX burn rate coming down. Again, yeah, it’s not a one big drop. You won’t see a one big drop. It’s gonna continue to come down over the quarters over the rest of the year.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: I think, Bruce, something just to say from a more of a take a step back. We are obviously cutting because we understand the climate and we understand Volition, and we need to cut. Also it’s a fundamental shift in the company, how we’ve spent a lot of our time and effort on studies, on research, on papers and processes, which we’re just not doing anymore to anywhere near the extent that we were. Because as you said, the French government is funding the interventional study in sepsis. Mayo Clinic did a lot of that work, obviously, in the trauma and is publishing itself. All those groups, Revvity are selling kits to in Europe are on the whole paying for the kits. We’re not funding those studies.

Overall, it’s coming down a lot because we are no longer spending our days doing R&D. We’re commercializing. I think we have an absolute pile of products which I think the world will be able to commercialize now. We’re shifting the cost base down quite a few notches so that we can, A, extend the runway, but B, it’s just a fundamental change in our business. We are not intending to do a lot of research studies anymore. We’re firmly in the commercialization path.

Bruce Jackson, Analyst, The Benchmark Company: Okay, got it. That’s it for me. Thank you for taking my questions.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thanks, Bruce. Take care.

Operator: We have reached the end of our question and answer session. I would like to turn the conference back over to Cameron for closing remarks.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you everyone for listening. I know it’s been a very interesting year for Volition, and obviously we’ve made a tremendous amount of progress. It’s been a tough year in a lot of ways, as you can probably all tell, but I think we’ve made very strong progress in a lot of areas, and I can assure you we’re absolutely focused on getting our products commercialized now. Hopefully we’ll have a lot of news on that through the rest of this year, and we can really turn the corner on the commercial side to be a strong commercial company where we’ve been a very strong R&D and IP company. Keep a close eye out. We should have a lot of news throughout the year. Thanks again for calling in. Bye.

Operator: Thank you. This will conclude today’s conference. You may disconnect at this time, and thank you for your participation.