VolitionRx Q1 2026 Earnings Call - Capture-Seq Breakthrough and Licensing Momentum Drive Strategic Pivot

Operator: Hello, everyone. Thank you for standing by. Welcome to VolitionRx Limited’s first quarter 2026 earnings conference 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. This conference is being recorded today, May 15th, 2026. I’d now like to turn the conference call over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.

Louise Batchelor, Group Chief Marketing and Communications Officer, VolitionRx Limited: Thank you, 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 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. Terig Hughes, Group Chief Financial Officer, will open the call providing a financial report before handing over to Cameron Reynolds, Group Chief Executive Officer, who will provide a summary of recent key achievements and upcoming milestones. We will then open the conference call to a question and answer session. With that, I’ll turn the call over to Terig.

Terig Hughes, Group Chief Financial Officer, VolitionRx Limited: Thanks very much, Lou, hello everyone. I’m delighted to provide a financial report for the first quarter ending 31st of March 2026. From a revenue perspective, we recorded approximately $1 million in the first quarter compared to approximately $0.2 million in the same period of 2025. This increase was primarily driven by a $0.7 million increase in deferred revenue recognition related to our Nu.Q Vet agreement with Heska, the result of a periodic review and consistent with our accounting policies. As we have stated previously, at this stage of commercialization, revenues remain fairly lumpy and difficult to predict from 1 quarter to the next. While we 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, the operating expenses for the quarter were $6.3 million compared to $5.8 million in the same period last year. This increase partly reflected severance costs related to cost reduction actions, which will result in future savings, as well as higher R&D costs related to work on our CaptureSeq and completion of certain lung cancer studies. As we reported in the recent 10-K, looking at the trend over the last 2 years, we now operate at significantly lower levels of expenditure. Furthermore, we have and will continue to take measures to reduce costs further in 2026. Net cash used in operating activities was $5.3 million compared with $4.3 million in Q1 2025, partly reflecting the timing of supplier payments.

Cash and cash equivalents at the end of the quarter totaled approximately $3.1 million compared to $1.1 million at the end of December 2025. Receipts in the first quarter included 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 LLC. We also continue to receive significant support from agencies of the Walloon region in Belgium with non-dilutive funding of approximately $1 million received and an additional approximate $0.9 million expected to be received in tranches based on certain time and event milestones over the next 12 months. This takes the non-dilutive funding support from all sources from inception to date to well over $25 million.

To summarize the finance report, revenue was up 300% year-on-year. Operating loss was 3% lower year-on-year. We continue to work on reducing our underlying operating expenses. As reported, we have made progress to secure a $5 million milestone payment from an existing agreement in the vet space. Last but not least, licensing discussions are progressing well, and to provide further detail, I will pass over to Cameron.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you everyone for joining Volition’s earnings call today. As always, we very much appreciate your time given the busy earnings season. The 1st quarter call always comes hot on the heels of the K, so I will try and be brief today. We have made some strong progress across all of our product pillars this year. Taking each in turn. Nu.Q Vet. The 1st quarter is always a busy conference season for the vet team, and this year was no different. With a booth and sponsored symposium at both VMX and WVC, the 2 largest veterinary conferences in the world. 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 for dogs.

This is a world first for us and will significantly enhance turnaround times and throughput to meet increasing demand. We believe that central lab automation is crucial for scaling 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 have also made great progress with our research into the use of Nu.Q in cats. Subsequent to quarter end, we announced the submission for peer review of a clinical manuscript reporting the high accuracy of our Nu.Q Vet Feline prototype assay in detecting lymphoma in cats, the most common cancer in the species. At 97% specificity, the assay detected 86% 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 vet 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 to subsequently unlock a $5 million contractual milestone payment, and we also expect it will generate ongoing revenue in this large and growing market where our technology meets an unmet need. Incredibly quick progress from a product development perspective, given it was only May of last year that we reported detecting nucleosomes in cats, the third species for Nu.Q. Next up, Nu.Q NETs.

NETosis really is an area of increasing scientific interest with a significant number of research articles published in recent years. I’ve spoken before about a number of manuscripts relating to the use of our Nu.Q NETs assay in sepsis, and this quarter, we reported findings in two further clinical indications. Firstly, in January, we shared a new clinical study demonstrating the use of Nu.Q NETs in patient management of a chronic disease, HS, a lifelong disease which affects approximately 1% of the world’s population. HS is a complex immune-mediated disorder with multiple pro-inflammatory cytokines contributing to its pathogenesis. The clinical presentation may also vary from person to person, making it challenging to manage. The findings described in the manuscript demonstrate that for the first time in an easy-to-measure blood test, Nu.Q NETs can be used to classify patients and to surrogate response to treatment.

In February, we sponsored a well-attended satellite symposium with key opinion leader Professor Evangelos and are continuing further work in the field. We look forward to sharing further data as it becomes available. From a chronic disease use case to very much an acute use case. Secondly, at the end of the quarter, we were delighted to announce the publication of a study at the Mayo Clinic in the Shock Journal. 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, are elevated in people that have experienced a traumatic event and are even higher in those patients that go on to have complications from the trauma. The numbers and data are quite stark and some of the most compelling data I have ever seen.

H3.1 levels in healthy people were low at 22.3 nanograms per mil. Those with trauma were elevated to 359.7. Those that went on to get venous thromboembolism, VTE, were 828.4 on average, over 37 times the level in healthies. The identification of reliable biomarkers in trauma patients is a clinical challenge and remains an unmet need in the emergency and surgical setting. Jae K. Oh, M.D., the principal investigator and senior author from the Mayo Clinic, said, These biomarkers could aid in the early risk identification and may inform targeted preventative strategies in trauma care. For my part, I believe this is a significant study with clear data, not only for the clinicians, patients, and their families, but also for Volition.

A peer-reviewed publication with the Mayo Clinic research team can only support our efforts to commercialize our Nu.Q NETs products. The Mayo Clinic team have continued their work with Nu.Q and are very much looking forward to sharing further updates in the coming months. Next up for Nu.Q NETs, a quick update on the DETECSEPS program. As a reminder, DETECSEPS is a French government-sponsored real-world evaluation of the early detection of sepsis and Volition’s Nu.Q NETs assay is the sole biomarker. The DETECSEPS program provides an opportunity to receive individualized and personalized care adjusted to the risk of deterioration and progression to sepsis. I’m very pleased to be able to say the program is on track, and we hope the first patient will be recruited in the third quarter of this year, likely September.

It is a privilege to be involved in such a program, and we hope that through the earlier identification of sepsis, lives can be saved. The quality of life of survivors can be improved, and importantly, the burden on the healthcare system can be reduced. Also, subsequent to quarter end, we were delighted to report the breakthrough finger prick detection of nucleosomes, thereby expanding global market potential for sepsis testing. This was a major technical milestone, the successful detection of nucleosomes in capillary blood from critically ill sepsis patients using our lateral flow prototype. This finger prick test sample could be used at the bedside, in the emergency room, or even at home with a self-test lateral flow kit, similar to COVID-19 or pregnancy testing, thereby greatly expanding the potential market beyond centralized lab testing.

The ability to rapidly identify high-risk patients at the point of care by quantifying their nucleosome levels using a finger prick sample and simple lateral flow device could enable quicker clinical decision-making and consequently better patient outcomes. We believe this is a potential game changer, not only in diseases where time is critical, such as sepsis, but also in significantly expanding potential use cases beyond traditional hospital infrastructure. It also creates a compelling pathway into underserved low-income countries where lab infrastructure may be weak or non-existent. An exciting development and one to keep an eye out for the future updates. Next, I’d like to talk about our Nu.Q Discover pillar, where we are commercializing our service offering for nucleosome-based biomarkers to drug developers and researchers.

The 1st quarter, we were excited to expand our collaborator network and extend the access to Nu.Q Discover through a non-exclusive agreement with Medical & Biological Labs Co, MBL. MBL is a leading provider of clinical research tools in Japan, with a particular focus and track record in autoimmune diseases. 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 pharma companies are progressing to late-stage clinical trials using our assays as pharmacodynamic biomarkers. Subsequent to quarter end, we launched our rNuQ webshop, offering a range of reliable, ready-to-use recombinant nucleosomes that we have developed over the past 10 years. Manufactured in our ISO 13485 certified facility, delivering reliable reproducibility and quality control.

Volition’s nucleosomes are stored and shipped at plus 4 degrees in glycerol-free buffer, simplifying handling while preserving structural integrity and experimental performance, thereby providing rapid access to high-quality nucleosomes for epi drug researchers worldwide. This is a potential new source of revenue on our path to commercializing our very large IP portfolio. Moving on to Nu.Q Cancer, and specifically Nu.Q 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 demonstrates that our Nu.Q Cancer technology empowers clinicians to make more informed treatment decisions and provides valuable new monitoring capabilities throughout the patient journey.

Several manuscripts and conference posters and presentations have already been published, and several more clinical papers have either recently been submitted for peer review or will be in the coming weeks. Together, this evidence provides the basis of our reimbursement submission supported by our long-term collaborators at the Hospices Civils de Lyon, one of Europe’s leading cancer centers. 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 tests to save lives. This submission is a significant undertaking, and we hope to participate in pre-submission meetings with the authorities in the coming weeks. Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q in the human cancer field, and once achieved, we anticipate the introduction into clinical routine use in France late this year.

The final pillar, which has generated a tremendous amount of interest this quarter, is Capture-Seq, which we have had several announcements about. Volition is, I believe, the first company to demonstrate the isolation and analysis of greater than 99% pure circulating tumor-derived DNA, ctDNA. To set the scene, the biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in the blood plasma samples comes from healthy cells, not cancer cells. In a world-first new technology, Volition has overcome this hurdle and produced greater than 99% pure cancer-derived plasma DNA sequencing sets for liquid biopsy.

We resubmitted our manuscript in March, available to view on Research Square. 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 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 the updated manuscript, we report a new 2-step method for preparing virtually pure circulating tumor DNA sets for cancer patients. Firstly, physical enrichment of the samples, and secondly, bioinformatic removal of virtually all remaining non-tumor cell-free DNA sequences from the DNA sequences data set.

This new method produces greater than 99% pure tumor DNA sequencing data sets for blood samples from cancer patients. Whilst we capture a subset of the tumor DNA, i.e., not all the 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 our chief scientist’s opinion, the biggest scientific breakthrough in cancer testing and monitoring in recent years. In addition to the manuscript, we also released data this quarter from a blinded validation cohort of 81 subjects, colorectal and lung cancer patients being 59 and healthy controls being 22. We are extremely encouraged by the results, particularly in early stage cancer detection, where we detected over 95% of stage 1 and 2 cancers.

For patients, the potential significance is huge. If further 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 MRD, 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. Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vets 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 we are now working with governments and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide as quickly as possible. We have continued to make good progress. Indeed, I would say that we’re delighted to have grown the commercial interest in CTCF in the first quarter, with an increase in discussions, including for technical evaluations. We set out 15 years ago 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 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 technology to be incorporated into tests that will be used by first 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 aim to 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.

We are very active with a range of potential partners, and we are continuing our discussions with more than 1 dozen of the world’s leading diagnostic and liquid biopsy companies to license and commercialize our very broad IP and product portfolio. These discussions are at various stages of the negotiation process across all of our different pillars. Our laser focus is on executing licensing agreements, and we’ll update you as they progress. Thank you for joining the call today. We very much appreciate it. We will now take your questions. Operator?

Operator: Thank you. We will now be conducting a question and answer session. Again, 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 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys. One moment please while we poll for questions. Our first question comes from the line of Justin Walsh with JonesTrading. Your line is now live.

Justin Walsh, Analyst, JonesTrading: Hi. Thanks for taking the question. I was curious if you could expand on the potential clinical utility of Nu.Q NETs and HS. Wondering how physicians might use the additional information to inform treatment decisions.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you. A lot of that work has been done by Evangelos Georgiou, who’s one of the world’s leading experts in HS. As we said on the call, we’ve had a satellite symposium. We’re actually working with a lot of other groups getting further data. I won’t go through the technical side. HS is a tricky, complicated condition. What I do know is some of the world’s best people are very keen on how it can be used to help. It is 1% of the world’s population, which honestly was news to me. I’m not familiar with the condition myself, but it’s supposed to be an extremely painful, extremely debilitating condition for a lot of the world’s people.

Evangelos Georgiou’s paper, and now I believe other groups are working on it as well, are very convinced that it could be a very big part of the solution. Yeah, I’m not the scientist involved. I’ll put you over to Louise. You want-

Louise Batchelor, Group Chief Marketing and Communications Officer, VolitionRx Limited: I can add a little bit of color, Justin. The way Evangelos Georgiou has used it thus far is really in helping identify patients that might be having a flare-up. It’s a chronic condition that is kind of often lifelong, and is can be under control with treatment, then people can unfortunately experience flare-ups. Really, they’re using the Nu.Q NETs assay to help monitor patients on an ongoing basis. His hope is actually then to utilize it within clinical studies of new therapeutics that are coming through. That’s kind of the direction of travel for HS. I think it’s definitely one to keep an eye on. I think we’ll have more news out about it throughout the year.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: The current diagnosis is I’ve actually spoken to Evangelos a few times, is a very complicated process, so they’re really hoping to simplify it, and he believes that’s possible with our tests. Just as a background, I guess, obviously in the NET space, there are so many potential uses. You know, obviously working with Werfen on APS, another autoimmune disease. Obviously, with the French government that’s doing this large interventional study in sepsis, so that’s all looking processed. Of course, I mentioned we’re incredibly excited with the Mayo Clinic data. Trauma is, I believe, the biggest cause of emergency in intensive care, emergency visits in the U.S. I think $40 million a year, and obviously it’s something tough to diagnose whether you have trauma or not.

I don’t know if you had a chance to look at the data, but it was quite, Yeah, it was fantastic, with 20 to 360 to over 800. Actually, one of the most important parts of that was the VTE section, whether you go on to having a blood clot, which is obviously incredibly important to know. I think overall, as you know, the Nu.Q NETs platform is extremely stable, now works on the Revvity machine at the point of care, which is fantastic on the pin prick with capillary blood. I think now we have a very wide range of really potentially large uses for it beyond sepsis. Actually, we’re working on another with a group in the U.S. which is exceptionally renowned as well.

We could have a fourth very big use for it as well coming up in the short term as well. Overall, the picture on NETs is really coming together between all those different conditions, and we’re hoping that will lead to the big companies putting it on their platforms and really trying to finish those discussions off with all these different uses.

Justin Walsh, Analyst, JonesTrading: Great. Thanks for taking the question.

Louise Batchelor, Group Chief Marketing and Communications Officer, VolitionRx Limited: Thank you.

Operator: Thank you. Our next question comes from the line of Yi Chen with H.C. Wainwright. Please proceed with your question.

Katie, Analyst (on behalf of Yi Chen), H.C. Wainwright: Hey, good morning. This is Katie on for Yi. You guys have kind of described discussions with a good number of companies at various stages. Can you give us an idea of what how far those have progressed? Have they reached a contract negotiation stage, term sheet? What’s kind of a realistic deal structure for those? I guess, what should we really be expecting from the next agreement?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah, very good question. Yes, we do have a lot of discussions going, and I think in the last quarter it’s actually expanded beyond the very large number we had. I think it’s fair to say a very large percentage of the large diagnostic companies and the liquid biopsy companies, and a range of other companies. As you know, we have signed some deals already with Hologic, with Werfen, and with Revvity being the machine platform for the IVDR launch in Europe and the IVDR. That’s gone extremely well. The NETosis stage, I think it hinges on getting the big agreements with the big diagnostic companies.

These very large use cases really well fleshed out, and I think, as I said, I think we’re getting there definitely on sepsis. Trauma has been a fantastic new entrance in the last quarter, with the Mayo Clinic and then Shock, as was mentioned. As, as I said, we’re also working on another very large use with a fantastic institution in the U.S. Of course, we have the Nu.Q Capture side, which interest has gone up tremendously since the paper was actually in preprint. On the preprint side, just as a background, it’s now been downloaded 2,700 times, which is quite, obviously it’s a huge amount of interest. Very fair to say a large amount of interest from a lot of groups on the Capture side.

Yeah, where we are with the different groups, all of them obviously we’re having discussions with. The more advanced ones are going through the stage of technical validation and their own trials on or at different technologies and their own processes, and that’s progressing well. We’re very happy with how they’re progressing. We’re doing a lot of work with quite a few of them. The actual terms and the processes is confidential until we finish, but what we’ve said, and if you look at deals that have been done in this space, they typically involve upfront payments or milestones and a share of the revenue going forward, either through royalty or through some other process like the sale of key components. We don’t update on each one individually.

Obviously, there’s confidentiality issues, yeah, we’re very happy with how they’re advancing. There’s a lot of discussions going on, we’ll continue to update as they come through. Certainly in the NETosis space and the Capture-Seq space with groups like Revvity, Hologic, and Werfen, we’ve made fantastic progress, we’ll update you as they come through.

Katie, Analyst (on behalf of Yi Chen), H.C. Wainwright: Great. If there’s time, I’d like to have a quick follow-up on Werfen and Hologic.

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

Katie, Analyst (on behalf of Yi Chen), H.C. Wainwright: Could you quantify what revenue has come in from those two so far this year? What kind of format it came in as, and kind of give us an idea of what conditions or triggers might produce more revenue from those deals for the rest of 2026, 2027.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah. Good, good question. Werfen, we’re working on APS. Basically, the NETs platform, as you know, as you can tell from everything, can be used in a very, very wide range of areas, from all the autoimmune diseases, sepsis, COVID, trauma, as we now know, and of course, you know, things like sepsis syndrome. I mean, extremely wide range of uses. What we’ve been working with different groups is getting them to either sign up for a big license for things like sepsis or for smaller uses, which then we hope to expand through other processes. Groups like Werfen, they’re in the process of showing how well it works in that autoimmune disease, as we also have HS on top of that, as you know. There was a small upfront payment which we’ve made.

Part of the contract, we don’t disclose that, but they have paid an upfront payment, and there are further payments being made from them. Not of a large scale yet because they’re still in the process of reviewing in APS, but we are working with them and other groups to broaden it beyond those first beachheads, if you will. Hologic has been working on a few agreements. We don’t break down the different individual revenues, but they are working with us on selling some of the Discover portfolio. Also with them, we’re looking at these as the first beachheads to expand it to other processes and other products. Companies like Hologic and Werfen and Revvity, where we have existing agreements, we are looking to really grow them through the process.

The bigger agreements which we’re working on, we expect to be coming with larger upfront payments and larger milestone payments, but the first ones we’re kind of working through those early projects, working through with Revvity, the launch in Europe, working with Hologic so they can sell our range of Discover products. The revenue from Discover, as you can probably tell, has gone extremely well and is growing strongly. We don’t break out what comes from them, but it’s going strongly as a group. Werfen, they’re working through APS now, and there was that initial payment. They’re all kind of starter agreements. We’re working to get bigger agreements with them and working on a very wide range of big agreements with the other companies.

We’ll update the other ones and the upgrades as they come through.

Katie, Analyst (on behalf of Yi Chen), H.C. Wainwright: Great. Thank you, guys.

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

Operator: Thank you. Our next question comes from the line of Steven Ralston with Zacks. Please proceed with your question.

Steven Ralston, Analyst, Zacks: Good morning, or good afternoon for you. My first question concerns the progress of the prospective clinical study at the Hospices Civils de Lyon. They placed their first commercial order for their internal validation process. How is that process going, and does Volition need to wait for the reimbursement dossier to be completed for an additional order, or is there a possibility it could be an order through I understand there’s funding through the MERRI G03 allocation process.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Okay. Well, Steven, I’ve not heard of the MERRI G03, but we can come back to that. There’s a couple of things that are still going on with the Lyon team. Firstly, from a clinical study point of view, they have a final clinical validation study that is called Ulysses Map, and that is ongoing. The recruitment has been completed, and that study now it just plays out ’cause it’s a longitudinal study. We hope to report that study later this year at ESMO 2026. That’s the clinical study. In terms of the certification of the product for use at the hospital, that has been completed. That work has been completed, so there’s no issues there.

In terms of the reimbursement, from a reimbursement perspective, we have compiled and sent into the relevant authorities, a clinical compendium for their review so that we’ve requested a pre-submission meeting. We’re now just awaiting with the team at Lyon and indeed a couple of other hospitals in France that are supporting us, the pre-sub meeting for reimbursement. A lot of work going on in the background, but we’re kind of on track, I would say, at the moment for Nu.Q Lung Cancer.

Steven Ralston, Analyst, Zacks: Thank you. Could you talk about the documentation that’s being used to support the Nu.Q test in the new in vitro diagnostic requirements for the CE mark?

Louise Batchelor, Group Chief Marketing and Communications Officer, VolitionRx Limited: I don’t have a lot of detail on that to hand, but just suffice to say that there is a team, they’ve worked on the IVDR submission.

all of the documentation that’s gone alongside that. We haven’t yet published some of that information that’s going to be used to support the IVDR application because I myself had sight of it today. The submission for IVDR status is ahead of schedule in terms of our IVDR application, and we’ll update you later in the year as that progresses.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: That’s something which is obviously going to be very important for us, Steven Ralston. Moving from IVDD to IVDR, as we’ve talked about, there’s like a dozen hospital networks now are reviewing it for more than 20 different uses. Beyond those very big ones that we’ve mentioned many times, trauma, sepsis, HS, APS, they’re working on a very wide range of different uses. Having that regulated product move from IVDD to IVDR is a very big point for us. As Louise Batchelor said, we’re very happy with how it’s going and everything is ahead of schedule. Expect to see a lot more on that this year as well.

Steven Ralston, Analyst, Zacks: Lastly, I see the number of this of potential licensees, the discussions with them, has gone up from 10 to 12 according to your latest press release. Could you talk about in general the pathway that leads these companies to initiate discussions with Volition? Is it the clinical papers, or is it the symposiums or the conferences that you attend with your posters and presentations, or are there some other avenues, or is it just a mixed bag?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: It’s interesting. Yeah, it’s a mixed bag. Some are inbound requests. Obviously, let’s just talk about the CaptureSeq paper, for example. You know, it’s been downloaded 2,700 times now. We’ve had some inbound interests. We’ve been in discussions with pretty much everyone for a while now on different things. They’ve often got back to us now that they’ve seen the new data that’s come through. On the Nu.Q NETs side, as we’ve come through with things like the Mayo Clinic paper, we’ve had a lot of discussions progressing, obviously contact them with such a great institute, having such great data in such a key area. We’ve had some very high level, very active discussions for a while and as the negotiations going on.

It’s a mixture of people we know from, you know, been around a long time who we’ve worked with, partners which have followed us in the space. Some have come through key opinion leaders, like in Evangelos’s case in the HS field. Some inbound, some outbound, some long-term relationships. Actually it’s 12, but there’s actually a bunch more that have kind of semi-active that we’ve been working through that have become active. Yeah, we’re very happy there’s been a pickup in all of that. And I think also, I mean, the cat paper’s getting close to we’re moving through the review process. Some vet people we’ve spoken to have contacted us again because of that.

Sometimes beyond the human space, back into the Vet space, obviously some of our groups we’re currently working with become interested in something new. They ask, you know, "Can Capture work in cats or dogs?" We get renewed interest, like that kind of thing as well. A bit of everything. All the things you said, we’ve got interest. I think it’s actually, if you add up all the big players, it’s pretty much everyone is interested at some level in liquid biopsy companies and large diagnostic companies and all the Vet companies. We’re getting a lot of interest. We know now our job is not to get interest, but close deals. We’re working on that very hard.

I’d have to say there’s a big wave of interest coming as the publications get close. For example, Capture paper is also working through the system, so that could be something which is out as well, and that’s another reason to reinvigorate discussions when you actually have a published paper. Yeah, we’re happy with how it’s going, and we’ll have a lot more to talk about this year, we think.

Steven Ralston, Analyst, Zacks: Thank you for taking my questions.

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

Operator: Thank you. Our next question comes from the line of Ilya Jukov with Freedom Broker. Please proceed with your question.

Ilya Jukov, Analyst, Freedom Broker: Hey, good afternoon. Thank you for taking my question. I have a question related to the launch of the rNuQ web shop. Could you provide more detail on your plans for developing this online channel going forward, and how should we think about the revenue contribution of this channel?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah, good question. Obviously we have, I think there’s no doubt now we have a remarkable platform that’s robust, reproducible, reliable. We have a lot of intellectual property, so that’s all fascinating, but people wanna see money. How does that make revenue? Obviously we spend a lot of time thinking beyond Nu.Q Discover, which is growing very well, and Nu.Q Vet, which is also growing, and all the licensing deals. How can we make money with what we have? We’ve become the experts at chromatin fragments and what we do. To get those chromatin fragments on an ELISA, you need a control. As you know, we’ve been making recombinant nucleosomes for a long period of time, and we’re working also on nucleosomes for sequencing. We’ve become very good at making them.

We do actually, it’s like a lot of things. It’s usually worth making 5, quite a large amount of them in one batch, so beyond what we need them for. We’ve had some inbound interest in the past for groups that need recombinant things for a whole lot of uses. They’re useful in a very wide range of, like in Nu.Q Discover, we have 100 clients. People have said, "you know, we are making extremely good recombinant nucleosomes now." We’ve did a bit of a market analysis, and it’s potentially quite a big market. We thought, let’s make it available and easy for people to, who want to order it to order it. On the revenue side, I guess Terry can say. Short answer is we’re not sure exactly how much the take-up’s gonna be.

They’re extremely useful to us, and I think potentially extremely useful to other groups. In the interest of getting all the revenue can wherever we can, we thought it was worth setting up. The cost obviously was quite low when setting up a recombinant shop, and we’ll be adding other things to it as well as we see how these go. We make a lot of different recombinant nucleosomes for our own research and processes, and I said, what we call Mustangs, which are recombinants for sequencing as well, which is potentially a really big market.

We’ll see how it goes in the next few months, and I think there will be an interest, but we’re not releasing projections now. Honestly, we’re not exactly sure what the take-up’s going to be, but we’re hopeful because it is very useful, and it wasn’t a lot of effort to make it out of the process. In the interest of making as much chance of revenue as possible, we put it on the market. We can update you over the coming quarters.

Ilya Jukov, Analyst, Freedom Broker: Mm-hmm. All right, got it. Thank you very much.

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

Operator: Thank you. Our next question comes from the line of Bruce Jackson with StoneX. Please proceed with your question.

Bruce Jackson, Analyst, StoneX: Hi. Good morning. A couple of questions on the vet space. With the feline milestone, that goes to deferred revenue, correct? Have you received the $5 million payment yet?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Terry?

Terig Hughes, Group Chief Financial Officer, VolitionRx Limited: You’re right, Bruce. That goes, that will, when we receive it, go to deferred revenue. We haven’t received it yet. What we have done is we’ve submitted the paper, which is part of the milestone, and when that paper gets published, that’s the completion from our end, at least of our milestone deliverables. After that, it would be a matter of time before we collect that milestone payment. You’re right, when we initially collect it would go to deferred revenue.

Bruce Jackson, Analyst, StoneX: Okay. A question about the product revenue for the quarter. What portion of that was from the vet business?

Terig Hughes, Group Chief Financial Officer, VolitionRx Limited: We don’t split out the individual pillars at this point. What I can say, you know, is that we’ve continued to make progress in the product revenue sales. We did see underlying growth there. As I mentioned in the earnings call itself, the big bump did come from deferred revenue, which we recognized $0.7 million of. That was a result of us reviewing, in line with our accounting policies, the revenue recognition and deciding that we recognize that a bit faster.

Bruce Jackson, Analyst, StoneX: With that, is that kind of the rate going forward, or was that kind of like a catch-up type of recognition?

Terig Hughes, Group Chief Financial Officer, VolitionRx Limited: Yeah. It’s partly a catch-up and, but the rate going forward will be a bit faster as well.

Bruce Jackson, Analyst, StoneX: Okay. That’s it for me. Thank you.

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

Operator: Thank you. We have reached the end of the question and answer session. I would like to turn the floor back to Cameron Reynolds for closing remarks.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you all for coming on the call today. I hope it was a good review. Just to reiterate, we are working very hard on the commercialization side. We’re in a lot of discussions, and we hope to have a lot of news on that throughout the year as well as on all the product developments and particularly in the Capture and the NETs space. Thank you very much for all your interest, and we look forward to catching up with you next quarter. Thanks for your time.

Operator: Thank you. This concludes today’s conference. You may disconnect your line at this time. We thank you for your participation.