VolitionRx Limited (VNRX) Q1 2025 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRX Limited First Quarter 2025 Earnings Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, there will be a question-and-answer session. [Operator Instructions] This conference is being recorded today, May 16, 2025. I'd now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.

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. Terig Hughes, Chief Financial Officer, will open the call with a full financial report before handing over to Cameron Reynolds, Group Chief Executive Officer for a business update and 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 Terig.

Thanks, Lou, and thank you, everyone, for joining Volition's first quarter 2025 earnings call today. We appreciate your time given the busy earnings season. 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 this quarter. Total operating expenses for the quarter declined 35% compared to the first quarter of 2024. This reflected cost reductions across all spending categories. As a result of the strong cost management, net cash used in operating activities was $4.3 million for the first quarter compared to $8.3 million in quarter one of 2024. Revenue-wise, we recorded almost $0.25 million of revenue in the quarter, a growth of 44% over the first quarter of 2024, including the first revenue recorded for sales of human product, a great 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. Cash and cash equivalents at the end of the quarter totaled approximately $2.6 million compared to $3.3 million at the end of 2024. Receipts during the first quarter included $2.3 million from a registered direct offering, $1.6 million in non-dilutive loan financing, and $0.2 million in grant receipts. Subsequent to quarter end, we finalized the convertible loan note to provide $6.25 million in gross proceeds, repayable in cash or shares over 24 months with an initial six-month repayment holiday. So to summarize the finance report, key indicators are trending positively. Revenue was up 44% year-on-year, including our first ever revenue for use of our Nu.Q technology in humans. Total operating expenses were down 35% year-on-year. Cash used in operating activities was down 48% compared to Q1 2024. We continue to receive non-dilutive funding support in the form of grants and loans from Belgian institutions. And last but not least, licensing discussions are progressing well. These items combined support our goal to be cash flow neutral for full year 2025. And with that, I will pass over to Cameron for a business update. Cameron?

Thank you, Terig, and good morning, everyone. 2025 is a pivotal year for Volition as we focus on commercializing our groundbreaking Nu.Q platform in the human diagnostic market. I'm delighted to report we are in confidential discussions with over 10 companies to license our products. Notably, the combined market value of seven of these companies exceeds $600 billion, underscoring the significant global strength, potential reach and impact our technology could achieve through such partnerships. Our goal is to secure multiple licensing agreements in the human diagnostics space, mirroring our successful strategy in the veterinary market, with diverse deal structures, all with ongoing revenue and some to include large milestone payments. Our strong clinical evidence supports the broad applicability of our Nu.Q technology in critical areas such as cancer and sepsis. These two disease areas alone represent a combined total addressable market of about $25 billion annually, offering substantial revenue opportunities for Volition and our future partners. As a reminder, all the pillars use almost exactly the same nucleosome technology, 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 collaborator platforms. The broad applicability of what we have developed is, I believe, completely unprecedented. Taking each pillar in turn, I will start with cancer. We are making significant strides in the commercialization of our cancer diagnostic pillar. From a licensing perspective, I am pleased to report that two major companies are currently in active negotiations and have either commenced or planning to commence the evaluation of our innovative Nu.Q and Capture-Seq technologies, with first results anticipated within the next quarter. Two incredibly exciting projects to look out for. Furthermore, our pivotal final lung cancer screening study in Taiwan is progressing very rapidly, with more than 100 patients already enrolled. The National Taiwan University Hospital, NTU, team is making great progress and aims to present interim analysis at the European Society of Medical Oncology Congress in October. Positive findings could position our Nu.Q test for inclusion in national lung cancer screening programs, representing a potential market exceeding $1 billion across Taiwan, the U.S., UK and France alone. And this could be implemented relatively quickly in several countries assuming Nu.Q Cancer is made available as a lab-developed test with no further need for regulatory studies. We are making significant headway in the commercialization of Nu.Q NETs as well. We have a two-pronged strategy. The first prong of our strategy is licensing to large international players. Licensing discussions are progressing well, with several potential licensing companies having already successfully completed the tech transfer of our assay onto their platforms. Our extensive clinical evidence supports the use of our Nu.Q NETs technology in a critical area, sepsis. The total addressable market for the testing and monitoring of intensive care patients alone represents $1 billion opportunity annually, offering substantial revenue opportunities for Volition and our future partners. We believe that the total addressable market of our Nu.Q NETs assay could be in excess of $10 billion annually as the use cases expand far, far beyond sepsis. The second prong of our Nu.Q NETs commercialization strategy is to leverage our granted CE Mark, which means approved for use in the European Union for any NETosis-related diseases. As a reminder, Volition’s chemiluminescent immunoassay, CLIA, version of the CE Marked Nu.Q NETs test is run on the IDS-i10 automated analyzer platform from Immunodiagnostic Systems, IDS, a subsidiary of Revvity. I would like to thank IDS for their collaborative approach. Our aim is to sell this product, either directly or in conjunction with IDS to institutions for use in a very wide range of clinical applications where NETs plays an active role. In a significant commercial milestone, we recorded our very first revenue from sales of CE Marked Nu.Q NETs automated product in Europe in Q1 of this year. This is our very first revenue generated from a regular clinically approved product in humans, which is quite a milestone for the company. Nine hospital networks in five countries have placed orders and are currently assessing its clinical utility in a range of NETs applications with the intention, we believe, of integrating it directly into their routine patient care. In addition, we are in discussion with a further 12 hospital networks with at least nine evaluations anticipated to start in the second half of this year. In short, a number of hospital groups are buying our CE Marked regulatory product with the view to using in clinically in a diverse range of NETs related uses. We are absolutely delighted with the level and breadth of interest that we have seen in the past six months, and we continue to receive more inbound inquiries. The range of potential clinical use cases where NETosis plays a role is extremely broad, equating to a mix of potential market sizes from small to very large. There is clearly wide unmet clinical needs driving these evaluations. NETs are a key part of a very broad range of clinical conditions, and our aim is to become the NETs company worldwide by partnering with the very best companies, hospital networks and governments. The level of interest in using our Nu.Q NETs test is notable. Clinical use cases include coagulation, cardiac issues, renal disease, trauma, burns, autoimmune diseases, organ transplants, pregnancy management and, of course, the biggest of them all being sepsis. This is an amazing outcome for Volition. Customers buy our kits, generating not only revenue but also clinical data for a wide range of broad clinical use cases. We expect through this second CE Marked sales prong that our Nu.Q NETs test will start to be used in routine clinical practice with patients next year in EU and then expand to use worldwide through the expected global licensing agreements of the first prong of our strategy. Next up, Nu.Q Vet. Expanding the global reach of our Nu.Q Vet Cancer Test remains a key priority enabling vets worldwide to improve canine cancer screening and outcomes. Our supply agreements with leading industry players, including Antech, which is part of the Mars Science & Diagnostics group, FujiFilm Vet Systems and IDEXX are instrumental in achieving this. To further accelerate revenue growth and ensure consistent delivery, we are focused on central lab automation. In March, FujiFilm Vet Systems extended their contract with us to validate and then implement a centralized, automated platform for the Nu.Q Vet Cancer Test using IDS’ i10. This is a world-first for us, and we believe that it will significantly enhance turnaround times and throughput to meet increasing demand. We believe the automation of central labs is crucial to accelerating our growth rate and this has become a particular area of focus for us. We aim to get our large customers automated so that they can easily and effectively handle the much larger number of tests that would result from having our tests in annual pet wellness panels. Importantly, this automated platform is the same technology utilized for our human diagnostic products such as Nu.Q Cancer, Nu.Q NETs and Nu.Q Discover, highlighting the inherent synergy and efficiency of our core Nu.Q technology. Next, our fourth and final pillar, Nu.Q Discover. Our 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 pharmacoepigenetics, studying the epigenetic basis for variation in response to drugs. The Nu.Q Discover pillar spans activities as diverse as supplying research use only kits either directly or via our U.S. distributor DiaPharma to providing services such as sample processing on-site in Belgium and California, either with assays or our recently announced high-throughput screening method. It also spans collaborations with drug developers utilizing our assays as a surrogate endpoint or pharmacodynamic marker with a specific drug in development. Following a successful pilot study, we announced this quarter that our Nu.Q Discover biomarkers are to be utilized in a human clinical study sponsored by a leading pharmaceutical company for the very first time. This was yet another significant milestone for our new Nu.Q Discover program, the first human study with a pharmaceutical company sponsor utilizing Volition’s biomarkers to measure disease progression and response to treatment in a longitudinal Phase 1/2b trial of an experimental drug. We are delighted to support the pharmaceutical company’s clinical efforts in developing new drugs for treatment of a large unmet clinical need. The inclusion of our nucleosome-based biomarkers in this clinical trial demonstrates the growing recognition of their value in clinical development. 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, which we believe will not only further validate the capabilities of our technology and strengthen our position in the pharmacoepigenetics market, but also generate future revenue. This approach represents a significant step forward towards Volition’s long-term goal of enabling precision therapy for patients. By identifying specific epigenetic signatures associated with disease states and treatment responses, Volition aims to help clinicians match patients with the therapies most likely to benefit them, while sparing them from treatments unlikely to be effective. This application of Nu.Q Discover in the Phase 1b/2 trial demonstrates how Volition’s nucleosome expertise is transitioning from research to clinical applications, creating value for pharmaceutical partners while advancing the field of personalized medicine. As this and future studies generate additional data about nucleosome-based biomarkers’ predictive and prognostic capabilities, Volition is well-positioned to expand its role in precision medicine and targeted therapeutic approaches. Another first this quarter was our first commercial sale of our innovative High Throughput Synthetic Sepsis model. This unique tool enables precise real-time measurement of Neutrophil Extracellular Traps, NETs, activation and inhibition in whole blood, supporting the development of new sepsis and other NETs-related disease therapies. We are currently in discussions with five other companies to finalize projects, positioning Nu.Q Discover as a key revenue driver this year. With over 10 repeat customers from our Nu.Q Discover kits and services, we aim to at least double revenue in this pillar in 2025. In drawing this call to a close, I would just like to add that throughout this first quarter and indeed subsequent to quarter end, we will continue to strengthen our clinical evidence supporting our pillars with presentations at several clinical and scientific conferences and the publication of several important manuscripts, with special thanks to our scientific, clinical, manufacturing, operations and intellectual property teams for their continued efforts. 2025 is about ensuring multiple licensing deals are signed in the human space, and we’re making good progress on this. We aim to leverage the valuable insights gained from our licensing and supply negotiations for Nu.Q Vet, where we have already received milestone payments of $23 million in addition to the ongoing revenue stream. The objective to sign multiple human licensing deals is similar to what we previously achieved in the vet space. Deal structure-wise, we aim to receive large milestone payments from some of these deals and ongoing revenue from all of them. 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 a range of commercial discussions progressing well with large companies. Discussions are also progressing well with several national lung screening programs. These next few quarters are hugely exciting for our company. I think it’s very fair to say that we have now developed a technology platform that has already been a breakthrough in veterinary oncology and we are demonstrating how we will also 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 very high unmet needs. It is a low-cost, robust and reproducible platform. 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 non-dilutive funding as possible, ramp revenue, 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 for joining the call today. We very much appreciate it. We will now take your questions. Operator?

Thank you. [Operator Instructions] Our first question comes from the line of Ilya Zubkov with Freedom Broker. Please proceed with your question.

Good morning. Thank you for taking my question.

Good morning.

So I want to start from the operating expenses that remained low this quarter. I’m just curious, is this a comfortable level for Volition to maintain through the rest of the 2025?

I’ll just have a quick answer to that, and then Terig can give you the details. I think it’s very important for us to manage costs. We’re obviously in a very important phase and the commercialization is where we’re focused. So we need to make sure that we’re as lean and putting the money to where it has to go in commercialization and products as possible. Terig, how sustainable is this, do you think where we’re going?

Yes. So this is – it’s a continued effort to keep a tight control over costs, and we’ve looked across all cost categories and all spending types, and we’ve made very good progress across the board. And yes, this is a focus for the rest of the year. So we’ll be looking to keep costs certainly lower than the prior year comparative. So yes, this is sustainable.

And it’s something we take very seriously. There’s been a lot of feedback from shareholders. For a company doing what we do, there are other companies in our space that burn through hundreds of millions of dollars a year. That’s obviously not what we want to do, and we can keep a very low-cost model because we’re licensing to big players. They do their lab work. They have their own machines. And we’re looking to get them to the regulatory studies on their machines. So certainly our aim is to keep it low, and we’re not really looking at adding any big things on because we really understand where the market is at the moment and what we need to do to make sure we keep control of costs. And that’s something that Terig’s done a very good job of, and I take very seriously. So we expect to keep it low.

Thank you. And one more question, if I may. Could you provide an update on the progress of the feline cancer test that is expected to generate a milestone payment?

Yes, absolutely. Actually, that’s an interesting one. So we’ve done a lot of work on that. And obviously, this would be our first species, so it’s a big milestone for us, apart from the products and the money. I’m very happy to be able to say we’ve actually – the next step was getting pre-analytics in cats are working. Now that paper has been published, I believe – already accepted. So it will be published soon. That’s the next step. And now we’re moving on to the clinical data. So it’s been a steady process. We had to show cats have quite a different blood and less of it, obviously, than a human or a dog. So we had to get the limit of quantification down and the pre-analytics, which doesn’t sound very important, but anyone who works in the lab knows is absolutely critical to actually doing a proper clinical study with valid results. So that’s all being done now, and that will be published soon. So yes, we’re making good progress.

That’s great. Thank you very much. I’ll pass the line.

Have a great day. Thank you.

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

Good morning.

Good morning, Steven.

Good morning.

First, on Nu.Q Vet, what’s your operational engagement with your partners like Texas A&M, IDEXX, Heska, Antech. In other words, do you receive any inputs about the potential sales flow?

Actually, we have like, I guess, 9 or 10 different partners now. So everyone is a little different. The bigger ones tend to be not really providing information. It’s commercially sensitive for them. We obviously know how many they buy. We obviously know how many they reorder, but they’re typically quite reticent about giving the very detail. I guess, it’s commercially sensitive to them. I’d very much like some of it. And so with our team, so we can do a deeper dive on analytics. But as a general rule, the answer is, they do not. And that’s not a thing for us. Its thing for anyone. That’s just their policies. And as you probably noticed, even these big companies have quite strict policies for everything. But the short answer is no.

Thank you. And just a follow-on to the previous question about the sustainability of the cost drop. Those two lines of research and development and sales and marketing, they’re down 44%, 45%. First of all, congratulations on that. But just looking – digging into the weeds at the marketing expenses, you are going to, well, or your partners are going to be attending conferences, that sort of thing. And I assume that’s under the marketing budget. Is that going to be a little bit more difficult to remain flattish for the rest of the year?

I do believe that's in the budget, Terig, no?

Yes. So we have planned for a lower level of spending this year. So if you remember last year, we had quite a lot of launches in the year. So spending was naturally higher at that point. And now it's – to a certain extent, it's sort of baked into business as usual. So yes, we will continue to attend conferences, particularly those where our partners are present. And we – if we need to, we will spend money. So it may well be lumpy from one quarter to the next. But overall, we've budgeted to spend less money this year versus last year.

Yes. And one thing I would add as well, Steven, in terms of what we're doing to try and save money is we're not – we're attending the conferences to do the networking and meet with the KOLs, but we're not necessarily hiring a booth because that's often what is the costly item at a conference. And so that definitely help us manage cost, but we are still active, say, for example, Dr. Retter and Dr. Terry Kelly are attending ATS this weekend, the American Thoracic Society. But we don't have a booth at that, so then the costs are limited to just registration and then kind of some of the networking costs. So that's the way that we've kind of clawed back.

Yes. And we still do. Actually our Chief Commercialization Officer, and collaborators also at the MedLab conference in Brussels in the next couple of days. But we just do it as cheaply as we can, but effectively as you can tell by the relationships. But I do think it's very important for a company in this environment. We really get it. It's money. Financing is a premium. So we make sure every dollar is used as wisely as possible. But having said that, we still need to spend money, obviously, to get the product out there, to get the negotiations. We're in front of the biggest companies in the world, so we've got to keep in front of them, but we're very mindful of that. So I believe all the costs we have. And we're actually not sitting on our hands. We are actually continuing to drive costs in every way we can while continuing to deliver licensing deals.

Thank you. And last question. Thank you for the update on the feline side. Could you do something similar to the progress of that human study contract that you entered into in Nu.Q Discover a couple of months, I know it's not much time. But when would we see some revenues or when would you anticipate some revenues from that hitting the income statement?

Yes. So I'll take that one, Steven. That clinical study is actually will run over up to two years. So it will be this year and into next year, so the revenue will be spread. So I think that we are taking the first set of sample in the second quarter, but then it will be spread out over a period of time, so it is a longer-term clinical study.

And just to answer, I've actually had a few questions about that. Obviously, in the press release, we did not mention the name of the company nor the size. That's obviously when you sign with big companies, and this is a big company, that's the stipulation. But there's an amount of money that we're very happy with and an organization which is a very large one and a purpose, which is extremely good and down our fairway. So if people read the press release, it's no wonder why sometimes we don't mention the names. We're very proud of the amounts mentioned and all the company and what they're doing. But those of you who deal with large companies know the first rule is, you don't have to mention any of that in the press release. Certainly not our choice. We're very proud, happy, and it's a landmark contract for us, being a Phase 1b/2 study and the amount of revenue was very meaningful, but we just can't in press releases. So I hope people understand the need for that, but it's certainly not from us, not wanting to talk about it. We're very excited.

Thank you for taking my questions.

Thank you, Steven. Have a great day.

And a good weekend.

Thank you. Ladies and gentlemen, that concludes our time allowed for questions. I'll turn the floor back to Mr. Reynolds for final comments.

Thank you, everyone, and thank you for joining the call today. It's obviously a very important time for us. We're now in the commercialization of all the different things we do. We've obviously just recently strengthened our balance sheet to give us sort of the runway to make sure that we can really kind of deliver on the milestones that we're working on now. It's incredibly exciting this quarter that we had our first revenue from our first licensed human – sorry, our first regulated human product in European Union, a very wide range of hospitals now looking at a very wide range of uses and also all the commercial discussions going on with the large companies on their platforms. So we're progressing very, very well, and the team is really working hard. It's a difficult environment at the moment, obviously, in the macro level. But I think we've done a very good job at staying focused, cutting costs and really getting the job done. So it should be a very exciting year. And I thank you all for your interest in the company. We really do appreciate it, and I'm looking forward to updating you on the next call and we should have made very good progress by then as well. So thank you again for your time.

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.