VolitionRx Limited (AMEX:VNRX) Q4 2024 Earnings Call Transcript

VolitionRx Limited (AMEX:VNRX) Q4 2024 Earnings Call Transcript April 1, 2025

Operator: Good afternoon ladies and gentlemen and thank you for standing by. Welcome to VolitionRx Limited Fourth Quarter and Full Fiscal Year 2024 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. [Operator Instructions] This conference call is being recorded today, March 31, 2025. I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.

Louise Batchelor: 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 the key highlights of 2024 and then pass to Terig Hughes, Group Chief Financial Officer, for a full financial report. Dr. Andrew Retter, Chief Medical Officer, will then share some significant progress from the innovation lab, R&D and clinical teams. Cameron will then wrap up with a review of more recent achievements and a look ahead to 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: Thanks, Lou and thank you, everyone, for joining Volition’s fourth quarter and full year 2024 earnings call today. We really appreciate your time given the busy earnings season. Our focus in 2024 was on generating sufficient clinical data to convince the biggest players in the diagnostic screening and liquid biopsy world that our Nu.Q platform will play a significant role in both the oncology and sepsis markets. I believe this was achieved beyond our expectations. We have now completed a number of large independent studies strongly supporting the value of our platform. 2025 will see the publication of many of these studies, as Andy will cover later. Our aim in 2025 is to sign multiple licensing deals in humans and we’re making very good progress on this.

There is a strong and broad interest in potential out-licensing and/or supply agreements for both Nu.Q NETs and our oncology portfolio with the range of commercial discussions progressing well with multiple large companies. We aim to replicate what we previously achieved in the vet space with a range of deal structures, all with ongoing revenue and some with large milestone payments. Volition is at a pivotal juncture, ready to revolutionize the diagnostics and monitoring of life-altering diseases for both animals and humans. The past year has seen significant milestones, including expanding access to the Nu.Q Vet Cancer Test across more than 20 countries, establishing clinical utility for both our Nu.Q Cancer and Nu.Q NETs tests and forging strategic discussions to commercialize our groundbreaking epigenetics portfolio.

As a reminder, all the pillars use almost exactly the same platform, making it extremely effective in both cancer and sepsis for human and animal health use. Volition is a company powered by Nu. Q and focused on one thing, measuring chromatin fragments in circulation. This one thing is the basis of all of our pillars. We now can measure nucleosomes on around half a dozen different established platforms. This broader applicability of what we have developed is, I believe, unprecedented. I’m immensely proud of the innovative clinical and scientific progress we achieved in 2024 and I’m delighted that Dr. Andy Retter, who joined as our Chief Medical Officer in April 2024, will provide a more detailed update later on our call. Before outlining some of our key highlights pillar by pillar, a couple of other notable additions to our team in 2024.

2024 saw the welcome of Chair, Mr. Timothy Still and Independent Director, Dr. Ethel Rubin to Volition. Both Tim and Ethel have tremendous experience in the diagnostic sector from both a commercial and financial perspective and are a real asset to the company. So on to the product pillars. First up, Nu.Q Vet. Expanding access to the Nu.Q Vet cancer test is one of Volition’s primary objectives. We want to ensure veterinarians worldwide can benefit from canine cancer screening, earlier cancer detection and improved outcomes for dogs in their care. We are realizing this aim through our supply agreements with industry organizations such as Antech, part of Mars Science and Diagnostics, Fujifilm Vet Systems, IDEXX and others. As a result of our market expansion activity, we are delighted that our Nu.Q Vet Cancer Test is now available to vets in over 20 countries.

We sold approximately 120,000 tests in 2024, more than double the prior year and resulting in a 75% increase in vet revenue compared to 2023. Our test is a simple, affordable and easy-to-use blood screening test. It can be integrated easily into preventative care programs and used alongside other routine blood work during regular wellness visits. In April 2024, Antech announced that their in-clinic version of the Nu.Q Cancer test was available to vets in the U.S. and Europe, operating on the Element i+ analyzer and providing vets with a rapid, accurate and cost-effective cancer screening tool at the patient side with results in minutes. Since then, Antech has rolled out our test in Canada, Australia, New Zealand, the U.K. and several countries in Asia with further expansions across their global network planned.

In July, VetLab, a leading veterinary lab in Poland, also introduced our test and is actively providing it to its client base. And also in July, Fuji Vet Systems in Japan launched our test nationwide and has achieved significant market penetration. Subsequent to year-end, Fuji extended their contract to utilize a centralized lab automated platform of our Nu.Q Vet Cancer test using the i10. This is the world’s first and will enable a more rapid turnaround and high throughput of our test to meet increasing demand. And it’s worth noting that this automated central lab platform is the same platform Volition utilizes for its human products: Nu.Cancer, Nu.Q NETs and Nu.Q Discover, demonstrating yet again the synergy across Volition’s Nu.Q technology platform.

While we have made strong progress in Nu.Q Vet in signing licensing and supply agreements with such a broad range of companies, we needed to make it scalable in centralized labs to achieve a larger and more consistent revenue ramp. The point-of-care market is very important and growing but it’s still less than 20% of the total market. It is proving difficult to run very large numbers of tests on our current ELISA platform which is based on manual processing. This is where the recently signed deal with Fuji is key. They plan to have our test running on the IDS automated platform this summer. We believe the automation of centralized labs is crucial to accelerating our growth rate. This has become a particular area of focus for us. We aim to get our large customers automated so that they can easily and efficiently handle the much larger numbers of tests that would result from having our tests in annual pet wellness panels.

Next, I wanted to share an update on our Nu.Q Discover pillar. Nu.Q Discover tools provide drug developers and scientists with a range of rapid epigenetic profiling assays across preclinical and clinical development pathways from discovery to market-ready. Nu.Q Discover is built on proprietary nucleosome quantification technology. It is a valuable research tool for R&D professionals working within the field of pharma epigenetics studying the epigenetic basis for variation in response to drugs. The Nu.Q Discover pillar spans activities as simple as supplying research use-only kits either directly or via our U.S. distributor, DIPpharma [ph], to providing services such as sampling processing on-site in Belgium or California, either with assays or our recently announced high-throughput screening method to collaborators with drug developers utilizing our assays as surrogate endpoints or pharmacodynamic marker with a specific drug in development.

We have more than 10 repeat customers for our kits, including large diagnostic and pharmaceutical companies. In 2024, we processed over 2,600 samples at our Belgium facilities for 13 customers, including providing services to 6 pharmaceutical companies, including 2 top 10 pharma companies with at least 3 of these companies commissioning more than 1 project. Discover revenue for 2024 was approximately $400,000 and we have an even stronger pipeline for 2025 which we will discuss in greater detail later. All in all, tremendous progress in 2024 for Nu.Q Discover and I will return to this when reviewing recent events later in the call. But for now, I’ll hand over to Terig for the financial report.

Terig Hughes: Good morning, everyone. As stated on our last call, one of our key financial goals for 2025 is to be cash-neutral on a full-year basis, meaning income, including licensing receipts, matches expenditure on a cash basis. And I’m delighted to report that across a range of financial indicators, we made significant progress towards this target during 2024. In 2024, we recorded $1.2 million in revenue, a growth of 59% over the full year 2023. Revenue from our Nu.Q Vet Cancer Test was $0.8 million and grew by 75% over the prior year. We sold approximately 120,000 Nu.Q Vet cancer tests and test components in 2024, more than double what we sold in 2023. Revenue from Nu.Q Discover was $0.4 million with year-on-year growth of 40%.

We also recorded our first revenue for Nu.Q NET, a significant milestone. It is worth noting, as we have stated previously, that at this early stage of commercialization, revenues remain fairly lumpy and difficult to predict from one quarter to the next. So while we remain confident of seeing solid growth on a full-year basis, we will not be providing revenue guidance for 2025 at this point in time. From an expenditure perspective, we significantly reduced operating expenses which were 23% lower compared to the full year 2023. Moreover, second-half operating expenses were 31% lower compared to the prior year as cost reduction measures disclosed previously took effect. Net cash used in operating activities was $25.9 million in 2024. This compared with $18.1 million in 2023 which benefited from the receipt of $13 million in milestone payments from Heska, now Antech.

Excluding those milestone payments, net cash used in operating activities was down 17% year-on-year. Cash and cash equivalents at the end of the year totaled approximately $3.3 million. During 2024, we continue to receive significant support from agencies of the Walloon region in Belgium, receiving approximately $1.8 million in non-dilutive funding payments. Subsequent to year-end, we received approximately $1.8 million of non-dilutive funding from institutions in Belgium and approximately $2.5 million from equity sales which included a registered direct offering to investors as well as sales through our at-the-market facility of $0.2 million. So to summarize the finance report, key indicators are trending positively. Revenue was up 59% year-on-year.

Operating expenses were down 23% on a full-year basis and trending lower with H2 2024 down 31%. We continue to receive non-dilutive funding support in the form of grants and loans from Belgian institutions and licensing discussions are progressing well. All these items combined support our goal to be cash flow neutral in full year 2025. With that, I will pass over to Andy for a clinical update.

Andrew Retter: Good morning, everybody and thank you, Terig. I’m very pleased with the incredible progress we have made from an innovation, scientific and clinical perspective across both the Nu.Q NETs and Nu.Q Cancer pillars in recent months. And indeed, some of our exciting work we have completed, we’ve got ongoing work with our Nu.Q Discover pillar. A range of large-scale independent studies were completed across the pillars. And whilst not all of this work is publicly reportable at present, we have certainly added it to our out-licensing data rooms in a meaningful way throughout 2024 and anticipate adding more publications in 2025. I have just returned from the European Lung Cancer Congress held in Paris last week and so I’ll begin my update with our Nu.Q Cancer pillar.

Lung cancer is the leading cause of cancer deaths worldwide, accounting for the highest mortality rates among men and women. In the U.S., it kills 3x as many men as prostate cancer and 3x as many women as breast cancer. Currently, lung cancer is often diagnosed at a very advanced stage and treatment options are limited, making it challenging to personalize care and to monitor an individual’s response and disease progression. Throughout 2024, we generated data to support our use cases from Nu.Q from screening to aiding treatment selection at diagnosis and monitoring treatment response and the burden of minimal residual disease and ultimately, disease progression. An 800-patient study demonstrated that Nu.Q Cancer was able to differentiate between malignant and benign pulmonary nodules found on low-dose CT scanning in patients suspected lung cancer.

These results were announced in December and published in March of this year. This is groundbreaking use of our Nu.Q Cancer test, allowing it to support physicians and clinical decision-making following low-dose CT. It enables them to identify patients at highest risk and those whose nodules are more likely to be cancerous. It also potentially identifies patients who present with low-risk lung cancer, therefore, could be followed up and avoid the need for unnecessary interventions such as a biopsy. And this is really reassuring and enables physicians precision medicine to benefit patients and improve their care. Subsequent to the end of the year, the team at NTU has enrolled the first patient in their final validation study funded by the Walloon region.

500 patients will be enrolled and this study is due to complete by the end of 2025. If these findings align with the previous results of the Nu.Q test, it may be considered in combination with national lung cancer screening programs, including but not limited to, Taiwan. More accurate screening potentially leads to a greater uptake of screening by patients, improving both the negative and positive predictive rate. This can lead to diagnosing cancer earlier, reassuring patients when they don’t have cancer and hopefully saving many, many lives. A second key collaborator in lung cancer is the Hospices Civils in Lyon, France. Their research looks at the use of Nu.Q throughout a patient’s cancer journey from aiding treatment selection at diagnosis to monitoring response to treatment and measuring the minimal residual disease burden.

And finally, it can assess disease progression. The initial study was published in 2023 and 2 manuscripts are currently in development for publication this year. Bringing you right up to date, I’ll simply highlight the latest findings reported at the European Lung Cancer Congress in Paris last week. The interim analysis of 832 patients demonstrated that Nu.Q H3K27 trimethyl is a strong prognostic marker in non-small cell lung cancer. H3K27 trimethyl is a noninvasive biomarker that complements circulating tumor DNA and predicts survival regardless of a patient’s previously determined mutation status. These exciting results confirm earlier studies that showed H3K27 trimethyl at diagnosis could help inform treatment decisions and patient monitoring, facilitating personalized care.

This study is now being written up. The aspiration is to submit it for peer-reviewed publication by the end of the second quarter. For further information about Nu.Q Cancer, I can signpost you to a recent report available on our website, hope for a brighter tomorrow. A great read highlighting the potential use of Nu.Q across the disease timeline. Lastly but by no means least from an oncology perspective, the research and development team have made some significant progress with the use of Nu.Q technologies in the diagnosis of solid cancers. Subsequent to year-end, a manuscript was submitted for peer review and is available on med archive detailing the results of the study which shows that an automated Nu.Q Cancer immunoassay currently in development detected a range of 21 different cancers.

This new test could potentially be used as a stand-alone pan-cancer test given its strikingly low false positivity rate among healthy people. And we hope to license out in conjunction with other liquid biopsy techniques to improve accuracy. We are excited to publish this further validation of our Nu.Q platform. It represents a significant potential opportunity to disrupt the liquid biopsy market and bring a new marker for improved multi-cancer detection to market. This is a breakthrough based on 15 years of developmental work by our scientific team at Volition. As Cameron mentioned earlier, we are in active discussions regarding our cancer portfolio with a number of large diagnostic and liquid biopsy companies. Our ambition is to sign at least one licensing agreement with these companies this year.

2024 was also an incredibly busy and productive year for Nu.Q NET2. We processed over 14,000 samples for more than 3,000 patients to generate significant supporting evidence for the use of our H3.1 assay. 2024 was all about completing these studies, 2025 is now about showcasing and presenting the data. Much like an earnings season, March is also conference season for clinicians. And so prior to ELCC, I had the pleasure of attending the International Symposium on Intensive Care and Emergency Medicine, ISICEM, one of the world’s leading intensive care conferences. What a conference it was for H3.1. The review article co-authored by myself and Professor Djillali Annane and Mervin Singer and published in Critical Care Medicine earlier this year has now been accessed over 2,250 times.

It was referenced extensively throughout the meeting with 2 figures, in particular, featuring in multiple presentations. Several key opinion leaders delivered presentations that thoroughly address the role and potential of Nu.Q H3.1. Dr. Love Boost presented our largest study to date of over 1,700 patients. Professor Michael Bauer presented the Jena study of just under 1,000 patients with sepsis and septic shock. And Professor Djillali Annane presented interim findings of the RHU RECORD study in France. The aim is to recruit up to 1,500 patients and Djillali shared data on over 500 patients. All 3 clinical studies use Nu.Q NET test to measure circulating levels of H3.1 nucleosome in the bloodstream. These serve as an excellent surrogate marker of neutrophil CL traps.

All 3 studies clearly and consistently show that an elevated circulating H3.1 nucleosome level in sepsis is associated with an increased risk of mortality, renal failure, multiple organ failure, disseminated intravascular calculation and septic shock. As a clinician, we hope that H3.1 will be extremely helpful. We know that H3.1 levels rise rapidly and early in a patient submission. This gives us a new tool to identify patients at the greatest risk of deteriorating and deteriorating fast. Hopefully, this will enable us to improve triage and act faster to save lives and improve care. We are honored to be working with so many leading clinicians in the intensive care community, having their support and advocacy is really important, not only for clinicians but supporting our ongoing discussions with a number of licensing partners.

Looking forward, we have presentations at other important conferences. I’m going to the American Thoracic Society in San Francisco later this year and the International Society for Thrombosis and Hemostasis in Q2 alone. There are other conferences in Q3 and perhaps one in Q4 as well. And importantly, in addition to all this clinical evidence, we also made great progress throughout 2024 in generating and publishing scientific evidence to support the role of H3.1 in NETosis. These papers from the innovation lab form part of a number of strands that we are weaving together to improve and support the justification for H3.1. And actually, having the scientific work enrich and support the clinical data is critical. We’re incredibly proud of the work from the innovation team.

Three papers have been published, Zukas et al, Atabri et al and Kaferd et al, while another paper, the Methods paper is currently out for peer review. These scientific papers underlie physicians’ scientific expertise and that expertise and knowledge around nucleosome technology and have proved to be of significant interest not only to key opinion leaders and clinicians attending conferences but to our licensing partners and they help reinforce and support the argument supporting the use and scientific justification for the 3.1 nucleosomes. These papers have been critical in answering the very detailed questions we get from licensing companies. All in all, very busy and very exciting times for Nu.Q NETs. And as I said before, 2024 was all about completing the studies, 2025 is about showcasing the data and taking the licensing deals forward.

Before passing back to Cameron, I would also like to touch on our Nu.Q Discover pillar led by my friend and colleague, Dr. Jasmine Qui. As Cameron mentioned at the top of the call, we’ve worked with more than 10 pharmaceutical companies in 2024 with Nu.Q Discover, including a number of companies who are repeat customers. Following a successful pilot study, subsequent to year-end, we announced that our Nu.Q Discover biomarkers are to be utilized in a human clinical study sponsored by a leading pharmaceutical company for the first time. This is a significant milestone for our Nu.Q Discover program, the first human clinical study with a pharmaceutical company sponsor utilizing Volition’s biomarkers to measure disease progression and response to treatment in a longitudinal Phase I, Phase IIb trial of an experimental drug.

We are delighted to support the pharmaceutical companies’ clinical efforts in developing new drugs for the treatment of a large and unmet need. This first study is expected to generate significant revenue for Volition. We are in further discussions with this and other companies and anticipate additional clinical studies. We believe these will not only further validate the capabilities of our technology and strengthen our position in the pharmacoepigenetics market but also generate significant future revenue. From my perspective as a clinician, I think it is incredibly exciting to incorporate Nu.Q Discover technology and biomarkers into a sponsor study design. Volition has been about enrichment, diagnostic enrichment, prognostic enrichment and refined personalized care.

If we improve the accuracy and specificity of diagnosis and treatment, we improve patient care. Both in terms of identifying patients at risk of disease progression, enabling to be diagnosed quicker, faster, more easily with less invasive technologies and hopefully optimize new therapies that they might respond to as well. By identifying specific epigenetic signatures associated with disease states and treatment responses, Volition aims to help clinicians match patients with therapies most likely to benefit them while sparing them from the treatments that are unlikely to be effective. The application Nu.Q Discover in this Phase I/IIb trial demonstrates how Volition’s nucleosome expertise is transitioning from research to clinical applications, creating value for everyone involved, pharmaceutical partners, Volition and most importantly, patients.

As this and future studies generate additional data about nucleosome-based biomarkers’ predictive and prognostic capabilities, Volition is extremely well-positioned to expand its role in precision medicine and targeted therapeutic approaches. In closing, I’d like to make one final point. I can fully appreciate that it sounds like we have an awful lot going on and that’s true. We are busy but it’s important to remember this is all based on one platform. All of our pillars are powered by Nu.Q nucleosomic quantification. The assays are reproducible and cost-effective and have been shown to work on around half a dozen different established platforms. Both sepsis and oncology indications have generated a great deal of interest from key industry players in the diagnostic and liquid biopsy space.

Both sepsis and oncology indications have certainly generated a great deal of interest from key industry players in the diagnostic and liquid biopsy space. Most importantly, they are generating increasing interest with licensing partners, too. Thank you very much for listening and I’ll now pass you back to Cameron.

Cameron Reynolds: Thanks Andy and Terig, for those comprehensive reports. I said at the top of the call, 2024 was about generating robust data to create a comprehensive package to convince the biggest players in the diagnostic, screening and liquid biopsy world that our Nu.Q platform will be a big part of both the oncology and sepsis markets. I believe, as I said before, this was achieved beyond our expectations. We have completed a wide range of large independent studies strongly supporting the value of our platform and we are already seeing a number of publications emanating from these studies. 2025 is about ensuring multiple licensing deals are signed in the human space and we’re making very good progress on this. We aim to leverage the valuable insights gained from our licensing and supply negotiations for Nu.Q Vet.

We have already received milestone payments of $23 million in addition to the ongoing revenue stream from every test sold. The objective to sign multiple human licensing deals is similar to what we previously achieved in the vet space. With a mix of deal structures, all with ongoing revenues and some with large milestone payments, there is a strong and broad interest in our potential out-license and/or supply agreements for both Nu.Q NETs and our oncology portfolio with a range of commercial discussions progressing well with large companies. In addition to licensing out our IP, we’re moving ever closer to having our Nu.Q platform being used in regular clinical settings for both oncology and NETosis. Our CE Marked Nu.Q NETs test has already been purchased by 3 centers of excellence in Europe and discussions are ongoing with 10 more across 6 countries, with the expectation of having clinically used in 2026.

For Nu.Q Cancer, as Andy covered, there are a number of potential applications. A further and likely final validation study in Taiwan is now underway. If successful, we could reasonably expect our test to be added to the national screening program in Taiwan next year. Discussions are also progressing well with several other national lung screening programs. These next few quarters are hugely exciting for our company. I think it is very fair to say that we now have developed a technology platform that has already been a breakthrough in vet oncology and we are demonstrating how we will make a significant contribution to both human oncology and sepsis diagnosis and treatment. We now have evidence to support the use of our platforms across a range of clinical applications with high unmet needs.

It is low-cost, robust and reproducible. Now we need to commercialize our technology as quickly and as well as possible to make our technology accessible worldwide. When successful, this will clearly support our mission of saving lives and improving outcomes for millions of people and animals worldwide. Our strategy to achieve this has been to raise as much nondilutive funds as possible, ramp revenues, reduce expenses and sign commercial deals with large industry players. Completing commercial deals for human indications are the final part of this long journey to complete our mission and we remain focused on achieving that objective. Thank you all for joining the call today. We very much appreciate it. I will now take your questions. Operator?

Operator: [Operator Instructions] Our first question is from Bruce Jackson with The Benchmark Company.

Q&A Session

Bruce Jackson: I wanted to just check on the Heska feline cancer testing program. Is that something that could happen imminently? Or is it a project that’s taking a little bit of time?

Cameron Reynolds: Thanks, Bruce. Yes, so we’ve done a lot of work, obviously, on the feline side. It involved our same platform as everything. We had to reduce the cats have very similar cancers and the same nucleosomes but we’ve adapted it for felines which means a smaller amount of blood. Obviously, cats don’t have as much blood as a dog. We’ve done a lot of adaptation work. That’s gone very well. And we’re in the stage now of seeing how it works in the actual animals themselves. So what we’ve said publicly and it’s still on track is to have that completed sometime this year. As you know, I guess, while you’re asking as well, we have another payment due from Antech of $5 million once that’s completed. So it’s making good progress. And as with everything else, it’s on the same platform, on the same — all of what we do but we’d expect to have that completed later this year.

Bruce Jackson: Okay. So you could get that milestone payment later this year?

Cameron Reynolds: That’s correct.

Bruce Jackson: And then, I wanted to follow up on the Lyon study. On the poster, they’re as excited as scientists ever get. I mean they said that it’s a complement circulating tumor DNA, predict survival regardless of mutation status. Have you had any discussions with them about how this test might be employed in a screening regimen or how it might be used in practice? And are they thinking after you get the results published, are they actually thinking about implementing this test?

Cameron Reynolds: Yes. Andrew, do you want to take that? Do you want to take that? Or shall I take it from a business point of view? Do you want to do the science and I’ll go through what we’ve discussed with them?

Andrew Retter: Yes, they are very excited. Yes, they plan to take it forward with prospective studies. If we confirm the result, there is a history of rapid adoption in cancer programs, then you could see that that is where it would be taken. And obviously, you can see that we’ve worked with two large centers in Taiwan and in Lyon. And obviously, there is crosstalk between those centers as well, really focusing on the work in Lyon, it’s about disease prognostication and following the progression of patients, whereas the work in Taiwan is about screening. And you can see how there is the potential for crosstalk and sort of validation of both those results there. So we’re very excited about the results generated and their future applicability and adoption in medicine. It’s really interesting. I can’t say too much but H3K27 is picking up a really interesting pathway which is great.

Cameron Reynolds: And further to your question, so we’ve obviously gone a long way with the Taiwan screening program on the very fundamental question of is the polyp cancerous or benign. I can’t say too much, obviously, because it’s under a lot of discussions but France is undergoing a national screening program. They’ve made a lot of decisions. We’re in very active discussions with that national screening program. On the fundamental question of screening as in Taiwan, also minimal residual disease and also prognostic value and palliative care. So I think it’s been incredibly exciting and this is something really in the last few months where we’ve really made breakthroughs into national screening programs in Asia and in Europe.

And the Asian one through Taiwan. We’re looking at several other countries in Asia which we’ve got very active discussions in. And of course, hopefully, hear a lot more about France. I’ve got to be careful because we’re in quite active discussions on that. But — and just for an order of magnitude of size, Bruce, smaller countries like Taiwan, we’re looking at tens of thousands of tests per year potentially. We are looking to charge up to $50 per test. So obviously, it’s a quite valuable one for us. And in the large screening programs in large countries in Asia or Europe, the potential is for hundreds of thousands of tests per year. So that would obviously be a transformational event for the company if that’s where Edenizyme going. As Andy said, our test works extremely well in a range of different areas with H3.1 and H3K27.

So I expect to hear a lot more on that later this year, both from Asia and from Europe. And we’re very hopeful France will be a big part of that as well.

Operator: Our next question is from Ilya Zubkov with Freedom Broker.

Ilya Zubkov: Sales volume in Q4 appeared somewhat volatile. So could you elaborate on the key drivers behind the quarterly sales trends and share some high-level outlook on the factors that may state that sales performance in 2025?

Cameron Reynolds: Terig, do you want to take that?

Terig Hughes: Yes, sure. Yes. Thanks for the question. So what we saw in 2024 was that the largest of our company customers tended to buy stock in blocks or batches. And sometimes they order in one quarter and then not in the other. And so that made the revenue pretty lumpy. Remember, a lot of these companies were coming online for the first time in 2024. But we did manage to expand access to over 20 countries. And in the end, we did deliver solid growth with 120,000 vet cancer tests sold which is double the prior year. In 2025, we’ll see automation in the central labs launching which will open up bigger opportunities with the reference labs which account for about 80% of the testing market. And then on the point-of-care side, we will benefit from the rollout of Antech’s Element i+ and growing the installed base.

And I should also mention our Discover pillar where we’re starting to see larger deals materialize and repeat customers which I think is demonstrating the value our customers derive from our technology. And then the key focus for 2025, of course, is on the licensing of our products and technologies in NETs and oncology, where we’re looking for some very large licensing deals with very major players in the industry which we believe will be game-changing for Volition.

Cameron Reynolds: And can I just add to that? I think the really good thing to remember here is all the main indicators are going in the right direction. Thanks to the great work Terig has done. The costs are way down and are going to stay down. I think that’s important to remember now that the bigger studies are all being completed. We’re not going to be having those large costs again. We’ve made very good cuts in every aspect of the company to make sure that the burn is as low as possible as we drive to these human deals which we think we’ll get a range of this year. So, with the cost down, the revenue is growing, as Terig said well. We expect the big pop will become when the centralized labs are running in the vet space. And we’re already seeing that in the Discover space.

You’ll start to see that again this coming quarters where the deals have gone from the tens of thousands to the hundreds of thousands, actually to the mid-hundreds of thousands in the later ones. So, that’s all trending very well. But as Terig said so well, the focus this year and what’s going to make the difference for the company is signing human deals as we did so well in the vet space. And also just something to keep in mind: I’m not sure it’s kind of didn’t get highlighted but I think it’s something will become more important for the company. We’re getting the first revenue on the CE Mark NETosis kits as well as groups in Europe start to buy them to do their own trials for their own launches. So, expect to see that revenue start to trickle in at first and then get bigger and bigger which is a huge milestone for the company, having people buying a regulated product in the human space which we do have on the Nu.Q NETs. So, the vet space will be a little lumpy in the meantime.

As Terig said, because of the nature, they often buy several quarters ahead but it’s all trending in the right direction.

Ilya Zubkov: And I have one more on the financial side. So, you have several non-dilutive financing options on the horizon for 2025. So, could you please share your approach to managing any time and risks associated with securing new financing?

Terig Hughes: So, as I said just now, I think what’s most important to remember is that we have reduced the cash burn coming into the year. Our large clinical studies are now over and the smaller studies that we’ve got ongoing to support the commercialization and licensing, typically with collaborators, are funded by grants from the Wallonia region. I think just in terms of the support that we’ve had from Wallonia region, that will continue. So, we’ve received $1.8 million so far this year. We expect that to continue. And the key focus is on driving towards those licensing agreements. Until then, we’ll keep a very tight grip on the expenses and the cash flows and we’ll continue to go along as we have in the last quarter or 2.

Operator: [Operator Instructions] Our next question is from Steven Ralston with Zacks.

Steven Ralston: One of the results of you producing so much data in 2024 is that I’ve noticed a tremendous step-up in your sharing of data at conferences, producing webinars, et cetera. The final, let’s say, endpoint is pursuing a licensing agreement and you’ve had these data rooms set up. How many do you have? Where are they? And what’s been the tenor of activities when you go to a conference and, say, have 3 different presentations? Does it step up the activity at the data rooms?

Cameron Reynolds: I’ll just take that from a commercial point of view and then Andy can add anything on. I think the data we developed actually very much exceeded our expectations and they were already quite high expectations. And yes, if you look at the data we’ve gone through, the reason for the data now is not data for data’s sake but to energize and keep moving the several numerous discussions we’re having with the biggest companies. So, keeping those discussions moving, the more data you have, you can keep updating them with all the processes and all the systems that we have. So, as we said, we have a data room for both oncology and NETosis. And every time some new data comes in, that’s a very good way to keep the different discussions moving and we’ve got a lot of different stages.

I think if we didn’t have the data, it would be very hard to prove to the biggest companies in the world that we have something very, very special. But as you said, given the huge volume we have, that creates excitement. So, there are several ways of getting the interest from the big companies, obviously, from the top by going through what we’re doing with the data rooms with their top commercialization and licensing people but also from the bottom, if you look at what we’re also doing and we haven’t talked about this a lot but it’s been very active and I think also very successful in getting the attention of the big companies is our big partners. And you can see we have some of the best key opinion leaders on the planet who are very, very enamoured with what we do.

I think it’s a very big part of the solution in oncology and in NETosis. And so having them contacting, they all use different machines from different companies, having them contacting those big companies to tell them that this is the next big thing really helps our case as well. So, I think it helps from the top negotiations that we have going on, the top-level discussions but also it’s bubbling along from the actual users of those machines. If a top key opinion leader in one of the countries for one of the areas and we’ve had several tells the big companies, they’re very supportive of what we do and they want it on their platform. It really helps us push things along. So, I think having the data has been absolutely crucial in getting as far as we have in the wide range of discussions on the licensing side.

And I think we expect to get several. It will be a very big part of that success, having this data and then just a continual updating of all this data really, really helps. Andy, do you want to add to that, in any way, the excitement from the conferences?

Andrew Retter: Yes. I repeatedly got stopped when I was queuing up for lunch and asked questions by people interested around me, et cetera. So certainly, at the ISICEM conference, there were 6 presentations where H3.1, in particular, was referenced directly. The review article that was referenced has now been accessed over 2,300 times. It’s only been published about 2 months ago. So, that’s a phenomenal rate of interest. The data from the data rooms, everyone will appreciate that some is shared under confidentiality agreements. And so there’s actually much more data supporting the science behind the test, the complex techniques behind it. Ideas around technology transfer, stuff that you don’t ever really publish around normal ranges and how those are interpreted and how those are produced and lots of other basic science, too.

So, the data rooms are very carefully curated to try and show all our data. And sort of as an overwhelming principle, it’s about putting patients first and showing the data and showing how it’s interpreted and that’s been very, very helpful in the licensing discussions. As Cameron has referenced, we are in discussion with a significant number of major large diagnostic companies.

Cameron Reynolds: I think it’s also important to mention there also we mentioned this but also probably the first time we mentioned it publicly. For the CE mark kit, we’ve targeted over a dozen different groups in Europe who can use it for different questions. We’re focused like a laser beam on the FDA side and the large company side on sepsis for NETosis but NETosis can be incredibly useful in a range of other areas as varied as cardiac as varied as things like COVID as varied as trauma, organ transplants. So, I think there’s a very good chance we’ll have multiple uses for our CE mark kit in Europe. They’re testing it now. They’re paid for it, for the CE mark kit from our suppliers and be launching that for a lot of different uses in Europe as well this year.

So, from our key opinion leaders from large companies, from different institutions, I think there’s been a really, really loud and growing drumbeat as to how important our NETosis kit will be. And on the cancer side, the publication of the paper, we’ve got it working now as well in liquid tumours in dogs as well as solid tumours in humans on the oncology side. And then you add the screening programs into that, it’s just quite remarkable what this one platform can do in all these different areas. So yes, we’re very excited for the rest of the year.

Steven Ralston: Just turning to Nu.Q Discover. You’ve alluded to both a step-up in activity and the quality of activity, particularly in this human study contract that you’ve landed. I’m going to try to address it in a different way. A few quarters ago, you mentioned that your average contract Nu.Q Discover was around $200,000. The human study one you said is larger and probably more profitable. Can you give us an idea of what the average contract is now?

Cameron Reynolds: Yes. So the smaller contracts, the start of the process, they usually want you to run samples as a sort of proof of concept and that’s in the small tens of thousands. The next level, we get, as you said, $200,000 perhaps $300,000. The next step beyond that is up to $500,000 or more. And then obviously, if you’re part of a companion diagnostic, you get very profitable and much, much higher figures well into the millions. So Nu.Q Discover, I think, is incredibly important at the moment as a big part of our revenue but also really getting out there in front of all these different companies. Now I would expect in 2 or 3 or 4 years’ time, it’s still a lot of money but not a big percentage of what we do because I think the NETs product has been hit out of the park and will become a very big mainstay of the diagnostic world.

But in the short term, the contracts in this stage in the hundreds of thousands and we’re moving into the mid hundreds of thousands. I’ve got to be a little careful because we’re under confidentiality and all these — you notice the press releases can sometimes be a little vague. That’s purely because we’re under confidentiality with these very large pharma companies and we obviously want to stick within the contracts but expect to see some in the more mid-hundreds of thousands of dollars this year and that’s what we’re discussing with several partners. And then that would move to step above that into the millions on the next stage. So very important to us in the short term, both for credibility and having a dozen different companies using our product and giving that kind of money to us starting in the tens of thousands and hundreds is obviously a big deal.

Steven Ralston: And my last question. Obviously, you’ve had 2 huge pillars have a lot of information data coming out during 2024, specifically NETs concerning sepsis and oncology. Not to get really into the weeds but could you just add a little color or expand on the — what you expect from the validation study, this new 500-patient study that’s happening at the National Taiwan University Hospital.

Cameron Reynolds: Yes. Actually, we’ve had updates from them. It’s going very well. They expect it to be finished this year and they’ve only started just very recently and they’ve actually done a lot of patients already. So that’s progressing very, very well. What we’re hoping is actually very simple, Stephen, is it replicates the data. So we’ve had 2 levels of data and the data was outstanding. It tells benign from cancerous nodules very, very well. We can cut back up to 50% of biopsies which is incredibly important. Obviously, biopsies are not something you want to do with a needle in your lung unless you really want — you really need to do it. So it has the potential of making a low-dose CT scanning a viable screening program in a lot of countries.

So all this study is doing is replicating potentially and hopefully and that’s certainly what we expect, replicating the data from the studies also carried out there. But something to really keep in mind, the group doing the study and the same lab are the same place it would be done as in the national screening program. So if it does continue to go well, we could have interim data this year, really supporting that and would expect to be finished by the end of the year is that it would be added to the national screening program. And there’s no more studies. There’s not another FDA route. It would be used in the same lab from the study and put into the screening program quite quickly if it goes as well as we would expect it to go. So very, very exciting.

And Taiwan is a great test market. There are a couple of much bigger countries in Asia we’re talking to. And as we discussed, some very big countries in Europe as well. But it’s not just benign nodules versus cancerous nodules. As you’ve seen in the data from France, it’s also very useful in minimal residual disease. It’s also on whether you need palliative care or not. So it’s — H3K27 is seeming to be a very good marker in lung cancer. And also a lot of the Discover projects or at least one big one is also in human cancer as well. So — and that’s something which we talked about could be a much higher value test per test because there’s 2 markers, one of which is a histone modification, as we talked about. So very exciting and expect to see some of that data later this year, we hope and it should be finished this year.

So it’s all really, really speeding up.

Operator: There are no further questions. I would like to turn the conference back over to Cameron for closing remarks.

Cameron Reynolds: Thank you, everyone. I’ll just give a very quick summary. So obviously, in the vet side, we’ve seen solid organic growth and we’re hoping for that pop from the centralized labs being completed. The first contract is now being signed and we’re hoping to have it several others later this year and that should allow the large quantities of tests to be run efficiently that we would expect from being as part of wellness programs. Also Nu.Q Discover, we’ve reached the next level and we’re starting to get much larger contracts in there with the very large pharma companies and diagnostic companies. So look for a lot there. We had some fantastic breakthroughs in Nu.Q Cancer. It is now working as well in solid tumors in humans as in liquid tumors in dogs which is really quite remarkable for such a low-cost test.

We’re in very active licensing discussions in a range of Nu.Q cancer areas as we are in Nu.Q NETs. The data we have come, I think, has been absolutely fantastic. It’s exactly what we wanted and it’s got the interest of the biggest companies in the world at a very high level and also from a large amount of key opinion leaders who think this is a big part of the solution as outlined by Andy. So 2024 was about getting the data. 2025 is about licensing in the human space which is what we’re really focused on now. And finally, just to remember one more time, this is all the same platform. We do not do 4 or 5 different things. We do one thing and we do it very well which is measuring circulating nucleosomes and chromatin fragments in circulation.

And the platform is now extremely robust, reproducible, reliable and it can be run on a range of different machines and plates and point-of-care. So it should be a very exciting 2025 and we look forward to updating you on all of these as they all come through throughout the year. So, thank you very much for your time.

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