Earnings Call Transcript - VNRX Q4 2025

Operator, Operator

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Full Fiscal Year 2025 Earnings Call. 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 and Communications Officer. Please go ahead.

Louise Batchelor Day, Group Chief Marketing and Communications Officer

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. And with that, I'll turn the call over to Cameron.

Cameron Reynolds, Group Chief Executive Officer (CEO)

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 new 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 real-world hospital settings, an extremely proud moment for our entire team. Cancer and sepsis are leading causes of death, accounting for approximately one-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, in antiphospholipid syndrome (APS), with Werfen; and a co-marketing service agreement with Hologic. Both are multibillion-dollar companies and worldwide leaders in their specialized fields, 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 ten of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the 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-marked Nu.Q NETs automated assay, a regulated, clinically approved product. NETs, or more specifically NETosis, goes far beyond just sepsis and is implicated in a very wide range of diseases. Currently, twelve hospital networks across a number of countries are evaluating our Nu.Q NETs assay across fifteen different clinical use cases and indications. We believe NETs testing will become a key part of routine blood testing. In February of 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 of 2025, Fujifilm Vet Systems extended their contract to implement a centralized automated platform for the Nu.Q Vet Cancer Test using the 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 (ChLIA) version of the Nu.Q Vet Cancer Test with Fuji Vet Systems in Japan, allowing use of full automation rather than microtiter 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 our vet business and integrating our tests 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. And subsequent to year-end, in early January of this year, we reported results from a clinical study demonstrating the high accuracy of our 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. And we will also generate ongoing revenue in this large and growing market where our technology meets an unmet need. Incredible progress from a product development perspective and great to add a third species for Nu.Q. The publication of this study is expected to unlock a $5 million milestone contract payment, and we will also generate ongoing revenue in this large and growing market where our technology meets an unmet need. I will return at the end of this call to discuss some additional recent achievements and upcoming milestones, but now will pass over to Terig for a finance report.

Terig Hughes, Chief Financial Officer (CFO)

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. And I'm delighted to report we received our first revenue from the CE-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. So 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. And 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 (ATM) facility and $1.9 million in net proceeds from issuance of a convertible note to Lind Global Asset Management LLC. We continue to receive significant support from agencies of the Walloon Region in Belgium. Subsequent to year-end, we announced nondilutive funding of approximately $2.3 million. This takes the nondilutive funding support from all sources from inception to date to over $25 million. So 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. And 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. And so with that, I will hand over to Andy and Jake.

Andrew Retter, Chief Medical Officer

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 our 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 Djillali Annane 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 UMC Amsterdam, looking at more than 1,700 critically-ill patients. Our 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 noninfectious 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 to promote the flow of patients for emergency rooms. This is a problem every health care system in the world faces. Not only is DETECSEPS led by prominent clinicians, it's also backed through 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. 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 the emergency rooms, 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 health care. I think you can understand why we say it has an impact in all health care settings. Our 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 nonexistent. 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 over 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 that provide 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 the 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 European Lung Cancer Congress. Both posters support the use of Nu.Q Cancer preoperatively to help identify patients at high risk. High H3K27 trimethyl nucleosome levels predicted poorer recurrence-free and overall survival outcome, whereas a lower H3K27 trimethyl 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 provide 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 to peer review 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 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. 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 of using our tests 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. And 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.

Jacob Micallef, Chief Scientific Officer

Thanks very much, Andy, and 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 CTCF DNA 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 nontumor 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. Whilst 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. 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. And with that, I'll pass over to Cameron for his commercial perspective and wrap-up. Cameron?

Cameron Reynolds, Group Chief Executive Officer (CEO)

Thanks, Jake. 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 markets (TAMs) for our technologies on an annualized basis are multibillion-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 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 ten 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, Operator

Our first question is from Justin Walsh with JonesTrading.

Justin Walsh, Analyst (JonesTrading)

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. And then 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 (CEO)

Yes. So we tend not to criticize the other companies. They are often well-run companies with good people trying to do good things. But I think it's very fair to say our discussions with everyone indicate that no one out there is currently where they really need to be in early-stage detection for multi-cancer detection, or in MRD for treatment-naive cases. There is 100% an opportunity for anyone who can develop something which is truly routine, low cost and easy to use, which we believe ours is. It certainly appears to be very accurate; we're doing more and more study, and the early work is incredibly encouraging. In any space like cancer detection, there will be a number of parties. No company, no matter how good the technology, will be everything. But I think there's a very strong case to be made that we will be a big part of cancer detection in the human space, like we are in the vet space, starting with the lung work, which is in the process of being reimbursed, which is encouraging, and of course the strong promise we have from Nu.Q Capture, which could either be used in conjunction with existing approaches or potentially as a standalone test. Given the early-stage detection that we have shown, that's certainly a possibility. So overall, I think we've got something very special. We're working with a number of groups now. Obviously, we can't disclose specifics; it's confidential. But we have a lot of active discussions going. These opportunities are far bigger than we can commercialize ourselves. The bigger companies certainly have the installed capacity or the expertise in particular areas, like screening and MRD. So we'll be updating as those hopefully come to fruition, hopefully in the near term. We're expecting a lot of news on that through the year. But as far as individual outcomes go, there have been several things in the market that have not met expectations. We always say we will succeed if we deliver a good platform. We haven't spent much time concerned about others. There's always going to be a place for a routine, accurate, low-cost test, and that's exactly what we think we've developed. So we're working hard on commercializing.

Operator, Operator

Our next question is from Yi Chen with H.C. Wainwright.

Yi Chen, Analyst (H.C. Wainwright)

My first question is, could you comment on how 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?

Cameron Reynolds, Group Chief Executive Officer (CEO)

I'll start with the deals. It's very hard to know exact timing. We've signed several in the human space already with strong partners. We're working with three multibillion-dollar companies in the human space now. Revvity has launched a CE-marked kit in Europe on its platform. Revvity via PerkinElmer is a very large company that likes what we do. We're working with Hologic on the Discover side for co-marketing, which is exciting. And we're working with Werfen on the NETs kit and process. If you look at each individual area, the NETs test will be something that's widely used. The uses go way beyond sepsis. The Mayo Clinic results show applicability in trauma with notable elevations. Trauma is a major cause of death and a major cause of emergency admissions, so another large use for our NETs test. We're in discussions with more companies now on the capture side, which is exciting. Governments are working on the lung cancer monitoring side. It's hard to say which of the ten or so companies will be first and in what order, but I strongly expect multiple deals with different companies and governments this year across cancer and NETs. We're also working with groups on our recombinant nucleosomes and on Discover. Don't forget, we have about 100 clients for Nu.Q Discover, and some are progressing into clinical studies that could generate meaningful revenue. Overall, I can't give you an exact number, but I'm quite certain we'll have deals. We're trying to get them out as quickly as possible because we have stopped much of the R&D work and are focused on commercialization. We have a large set of opportunities across all pillars and are pleased with how those deals are progressing. For the volume ramp question, I'll hand over to Terig.

Terig Hughes, Chief Financial Officer (CFO)

Yes. So as Cameron mentioned earlier, we're in the process of preparing the reimbursement submission. That's obviously an H2 event in terms of approval. We'd expect it to be about Q4 by the time we get that reimbursed product into routine clinical use. We haven't built a huge amount into our model for the year given the timing, but we would expect it to ramp fairly quickly once it's in routine clinical use.

Cameron Reynolds, Group Chief Executive Officer (CEO)

And the Nu.Q NETs now is in IVDD and in the process of transitioning to IVDR, so we're recording some revenue for that. But at the moment, we're not providing formal guidance, to be conservative. There's a lot of things happening and they're all moving forward, but exactly when in the year each piece happens will greatly affect when we can start recurring revenues. They're all making progress and we think they'll be coming on stream in the next few quarters.

Operator, Operator

Our next question is from Steven Ralston with Zacks.

Steven Ralston, Analyst (Zacks)

I looked into the revenue streams that you expect from the different pillars going forward and it seems 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 comment on the rate of acceptance of the vet test for canines among the different partners you have? And are there any commonalities of the more successful ones in how they've ramped up usage?

Cameron Reynolds, Group Chief Executive Officer (CEO)

Yes. So there are several different partners. Between them, the strong message we've got is that the key to scalable revenue is central lab adoption. Currently, the vast majority of the market—over 80% of testing in dogs—is done through centralized labs. Until recently, the primary option for centralized labs was microtiter plates, which is not ideal for scaling to hundreds of thousands or millions of tests. Fujifilm have been fantastic partners and proactive; they've now shown it works on centralized lab automation. The Revvity machines are being used for NETosis in Europe and for vet automation. That will start flowing through. The market remains lumpy quarter-to-quarter depending on when partners order batches, because plates can last a long time. Antech has launched smaller machines, but their growth depends on machine deployment. So it's not an immediate exponential growth. However, the completion of centralized lab validation is a major enabler for large-scale rollout. We're also making good progress in feline testing, which opens additional market opportunities. We have Nu.Q Capture potential applications across vet and human too. So while vet has not been the primary focus recently—the company has shifted much effort to the human space—we have made progress in cats and centralized labs, and automation will accelerate throughput when adopted by partners. In the meantime, revenues are lumpy as partners deploy systems and order plates.

Steven Ralston, Analyst (Zacks)

Now you even went into an area that I wanted to ask you about next, that in Europe you seem to have a very strong foothold with hospital networks in the areas of sepsis and lung cancer. Is that a model for your global emphasis or did it just happen to be the first foray?

Cameron Reynolds, Group Chief Executive Officer (CEO)

It's a bit of everything. What we have in Europe includes a strong partner in Revvity/PerkinElmer, whose machines our tests work well on, and there are over a dozen large hospital networks testing our products. Our CE-marked NETs assay is applicable to NETs-related inflammation across many conditions. The Mayo Clinic work demonstrates utility in trauma as well, which is a major clinical area. We don't want to try to run every study; our strategy has been to get partners to do much of the clinical work—Werfen, for example, in inflammatory diseases—and to work with large diagnostic companies to scale adoption. The French government-funded interventional study is a pivotal effort: if it goes well, it could establish our test as the standard in France and help drive adoption across Europe. That would then make it easier to partner for a U.S. regulatory pathway such as a 510(k). So yes, the European hospital-network model is an important part of our global strategy, and now we are engaging large diagnostic companies for global deployment. It's also important to note an interventional study means the test is being used on real patients in real clinical decisions, which shows a high level of confidence from the clinicians and funders involved. That level of clinical trust is very valuable for global commercialization.

Operator, Operator

Our next question is from Bruce Jackson with the Benchmark Company.

Bruce Jackson, Analyst (Benchmark Company)

I wanted to follow up on the Capture-Seq paper; it's a strong study. I'm curious how amenable this process is to front-end automation in the lab and how easily it could be integrated into an MRD test or a liquid biopsy workflow in the lab?

Jacob Micallef, Chief Scientific Officer

Bruce, thanks for the question. The updated, revised version of the manuscript is live on Research Square now, so it's public. The basic process involves two parts. The first part is a magnetic antibody capture—similar in concept to an immunoassay—and the second part is sequencing. Immunoassays are easy to automate, and the sequencing step is actually less involved than many current approaches because we've removed much of the background DNA. With the background removed, sequencing requirements can be lower and data analysis is simpler, since most of the analysis in other methods focuses on distinguishing tumor-derived from non-tumor DNA. If you've removed most non-tumor DNA, detection becomes more straightforward. At the moment we run the process manually, but it is highly suitable for automation.

Cameron Reynolds, Group Chief Executive Officer (CEO)

Just to add some commentary on costs, Bruce, the capture component—the magnetic bead and antibody immunoassay—might cost us around $100 today, though we expect that to decrease with scale, perhaps toward something in the $60–$80 range rather than very low single digits. Sequencing costs depend on the panel design and depth; it could be a few hundred dollars or more depending on how extensive the panel is. Shallow sequencing approaches or optimized panels could reduce costs. This is not a low-cost ELISA-style test, but it has strong potential to be tissue-specific and highly accurate. We believe the market could bear a price of a few hundred dollars for a high-value test like this. Partners and potential licensees are evaluating cost and sequencing design as part of commercialization discussions.

Bruce Jackson, Analyst (Benchmark Company)

Okay. Great. Then 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 a second quarter event potentially or third quarter? And then last, 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 (CFO)

It's difficult to predict exact timing, but we do expect to collect that $5 million milestone this year. We are in the process of submitting the paper, which is the final step to complete the requirements for the milestone. We expect that to be completed shortly, and while I can't specify the exact quarter, we expect to collect the payment this year. Regarding operating expenses, we've made a lot of progress over the last 18 months in bringing costs down. We're operating at a significantly lower burn rate than we were 18 months ago. Nevertheless, we're continuing cost-saving actions and are targeting further reductions of approximately 25% to 30% from cash operating expenditures over the course of this year. That reduction won't all happen in one quarter; it will be phased through the end of the year so that the exit run rate is that much lower. The quarters can be lumpy and the first quarter is often a little heavier with some severance costs to account for, but we expect the cash OpEx burn rate to come down through the rest of the year.

Cameron Reynolds, Group Chief Executive Officer (CEO)

To add a broader perspective, we're cutting costs because it's the right move in the current climate, but it's also a fundamental shift in how the company operates. We've reduced internal R&D spending and are focusing on commercialization. Many studies are now being funded or executed by partners and clinical collaborators—such as the French government funding the interventional study in sepsis and the Mayo Clinic leading the trauma study—so Volition is not funding those studies to the same extent. Overall, the cost base is coming down because we're moving from an R&D-centric company to a commercializing company. This will both extend the runway and support a sustainable commercial path.

Operator, 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 (CEO)

Thank you, everyone, for listening. It's been a very interesting year for Volition and we've made a tremendous amount of progress. It's been a tough year in a lot of ways, but we've made strong progress in many areas. I can assure you we're absolutely focused on getting products commercialized now. Hopefully, we'll have a lot of news 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, Operator

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