Earnings call transcript: VolitionRx Q2 2025 sees revenue rise, stock dips

VolitionRx Limited (VNRX) reported its Q2 2025 earnings, highlighting a 15% year-over-year revenue increase to over $400,000. Despite this growth, the company’s premarket stock price declined by 2.64%, reflecting mixed investor sentiment. The company reported a net cash usage reduction in operating activities and emphasized its strategic focus on achieving cash neutrality by the end of 2025.

Key Takeaways

• Revenue increased by 15% year-over-year to over $400,000.
• Net cash used in operations decreased by 30% year-to-date.
• Stock price fell 2.64% in premarket trading despite financial improvements.
• VolitionRx is focusing on expanding its Nu.Q platform and securing licensing agreements.

Company Performance

VolitionRx demonstrated strong operational performance in Q2 2025, reducing total operating expenses by 9% compared to 2024. The company’s strategic initiatives, including the expansion of its Nu.Q platform, have positioned it well in the competitive diagnostics market. This performance aligns with industry trends focusing on innovative diagnostics solutions.

Financial Highlights

• Revenue: Over $400,000, a 15% increase year-over-year.
• Net cash used in operating activities: $6.3 million, down from $6.7 million in 2024.
• Cash and cash equivalents: $2.3 million, a decrease from $3.3 million in 2024.
• Funding: Received $6 million from a convertible loan note and $1.2 million from a registered direct offering.

Market Reaction

Despite positive financial results, VolitionRx’s stock price dropped by 2.64% in premarket trading, settling at $0.627. This decline may reflect investor concerns over the company’s cash position or broader market trends. The stock remains within its 52-week range of $0.395 to $0.94.

Outlook & Guidance

VolitionRx anticipates securing its first human out-licensing deal in Q3 2025 and aims to become cash neutral by the end of the year. The company projects continued revenue growth, supported by licensing agreements and the expansion of its Nu.Q platform across various medical applications.

Executive Commentary

CEO Cameron Reynolds highlighted the company’s progress: "We now have evidence to support the use of our Nu.Q platform across a range of clinical applications with high unmet needs." He also reiterated the goal of achieving revenue neutrality, emphasizing the strategic focus on expanding the Nu.Q platform.

Risks and Challenges

• Cash Position: The company’s cash and cash equivalents have decreased, posing a potential liquidity risk.
• Market Competition: Intense competition in the diagnostics market could impact growth.
• Regulatory Approvals: The regulatory approval process for new products typically takes 2-3 years, which may delay revenue realization.
• Economic Conditions: Broader economic pressures could affect market demand for diagnostic solutions.

Q&A

During the earnings call, analysts inquired about the timeline for securing licensing agreements and the potential for immediate revenue from new market segments. VolitionRx executives expressed confidence in their strategic initiatives, noting high interest across all Nu.Q platform applications and ongoing discussions with potential partners.

Full transcript - Volitionrx Ltd (VNRX) Q2 2025:

Conference Operator: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited’s Second Quarter twenty twenty five Earnings Conference Call. During today’s presentation, all parties will be in a listen only mode. Following the presentation, the conference call will be opened for questions. This conference is being recorded today, 08/15/2025.

I’d now like to turn the call over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.

Louise Batchelor, Group Chief Marketing and Communications Officer, VolitionRx Limited: Thank you 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 ks, 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. Teri Keyes, our Chief Financial Officer, will open the call with a full financial report before handing over to Doctor. Andrew Retter, our Chief Medical Officer, who will present highlights from across our product pillars. Cameron Reynolds, Group Chief Executive Officer, will then provide 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 Tarek.

Tarek Keyes, Chief Financial Officer, VolitionRx Limited: Thanks, Lou, and thank you everybody for joining Volition’s second quarter twenty twenty five 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, licensing receipts, matches expenditure on a cash basis. This is dependent on executing one or more licensing agreements in the human space with significant upfront payments, receiving certain milestone payments in the vet space and reducing our spend. And I’m happy to report we continue to make solid progress against each of these targets, and Cameron will provide a progress update on the many commercial opportunities later in the call.

Total operating expenses for the second quarter declined 9% compared to the 2024, primarily reflecting lower personnel costs and lower research and development expenses. As a result of the strong cost management, net cash used in operating activities was $6,300,000 for the second quarter twenty twenty five compared to $6,700,000 in 2024. For the 2025, net cash used in operating activities totaled $10,600,000 down 30 over the same period prior year. Revenue wise, we recorded over $400,000 of revenue in the quarter, bringing the first half of total revenue recorded to a little over $650,000 Total revenue was up 15% in the first half, and I’m also delighted we recorded the first revenue for sales of a human product, Nu. Q Net, 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 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 $2,300,000 compared to $3,300,000 at the 2024. Receipts during the second quarter included $6,000,000 in net proceeds from a convertible loan note. Subsequent to quarter end, we also received $1,200,000 from a registered direct offering, which included participation by some of our directors. So to summarize the first half, revenues were higher by 15%, total operating costs lower by 22%, net loss improved by 24%, cash used in operations was lower by 30%, and as Cameron will expand on later, we made great progress in advancing our licensing discussions.

And with that, I will pass over to Andy for a summary of recent achievements in our clinical study program. Andy?

Dr. Andrew Retter, Chief Medical Officer, VolitionRx Limited: Thank you, Tarek, and good morning, everybody. I’m very pleased with the incredible progress we have made from our innovation scientific and clinical perspectives across both Nu. Q Cancer and Nu. Q Nets pillars, and indeed some of the exciting work we have completed and have ongoing in our Nu. Q Discover pillar.

A range of large scale independent studies were completed across the pillars. And while not all of this progress is publicly reportable, we continue to add to our out licensing data rooms and anticipate adding more publications in 2025. In terms of Nu. Q cancer, one of our key collaborators is the Hospice de Seville in Lyon, France, and I’d like to start by discussing some of their recent research, which looks at the use of Nu. Q through the patient’s cancer journey, from aiding treatment selection at diagnosis, to monitoring response to treatment, minimal residual disease, and disease progression.

As a reminder, their initial study was published in 2023, and two manuscripts are currently in development for publication. During a poster session at the recent European Lung Cancer Congress, interim analysis of eight thirty two patients showcased that Nu. Q H3K27 trimethyl is a strong prognostic marker in non small cell lung cancer. H3K27 is a non invasive biomarker that complements circulating tumor DNA and predicts survival regardless of the patient’s cancer mutation status. These were exciting results confirming earlier studies showing that H3K27 nucleosome levels at diagnosis could help inform treatment decisions and patients monitoring, thereby facilitating personalised care.

This study is now being written up, with plans to submit for peer review in coming months. The commercial team, led by our Chief Commercial Officer, Gaelle Forte, are working to facilitate early adoption of this test, and we are very happy with the progress on commercialisation. Another long term collaborator is the National Taiwan University team, who continue to enrol patients at a steady pace in their final validation study, which has been funded by the Walloon Region. We’re aiming for 500 patients, and the study is due for completion by the 2025. We, and indeed the team at NTU, believe our groundbreaking MuQ cancer tests could support physicians with clinical decision making following low dose CT scan, by enabling them to identify the patients at highest risk, and those whose nodules are more likely to be cancerous, while potentially identifying patients who present with a low risk of lung cancer for follow-up, avoiding unnecessary biopsy.

If the findings of this final 500 patient study align with the previous results, the new Q test may be considered for use in combination with any national lung cancer screening programs, not just limited to Taiwan. More accurate screening could lead to a greater uptake of screening by patients and greater adoption of lung cancer screening programmes by governments across the world. This in turn should lead to lung cancer being diagnosed earlier and saving many, many lives. Cancer remains the number one cancer killer worldwide. The NTU team are on track to present interim findings at the European Society of Clinical Oncology meeting, ESMO, in Berlin in October.

Our Chief Scientific Officer, Jake, is heading over to Taiwan with several other Volition members next week to review not only these initial results, but also to discuss how the test could be implemented into the Taiwanese screening program. This reflects great progress indeed. For more information about Q cancer, please could

: I signpost you to a recent report available on our website. Hope for a

Dr. Andrew Retter, Chief Medical Officer, VolitionRx Limited: brighter tomorrow. It is an informative read highlighting the potential use of Nu. Q across the disease timeline. We look forward not only to sharing under NDA the evolving data with our potential licensing partners, but also to submitting manuscripts for peer review and presenting at several conferences in Q4. 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 for multi cancer early detection. Now, from a nu.qnet’s perspective, we were delighted that our large independent study conducted by the Mars consortium was peer reviewed and published in the second quarter. In this large observational study, we demonstrated the plasma nucleosomes, represented by H3.1 nucleosome concentration, are associated with the presence of sepsis, the severity of organ dysfunction, and a hyperinflammatory host response. This study demonstrates and confirms that MuQ H3.1 is a clinically meaningful, biologically specific marker of neurosis, with actual potential in defined subgroups.

Patients with acute kidney injury, disseminated intravascular coagulation, and acute respiratory distress syndrome exhibit significantly higher Nu. Q H3.1 levels when compared to those patients without these conditions. As I have mentioned on previous calls, H3.1 nucleosomes reflect the biological process of NETosis, supporting the emerging concept of treatable traits and biologically informed risk stratification to facilitate and enhance patient care. The implications of our results are that mitosis and H3.1 nucleosomes in particular play at the intersection of infection, organ failure, and inflammation, and they are not simply a surrogate marker of these conditions. This opens up the opportunity of identifying how excessive NETosis can be treated and modified in patients with a high NETosis phenotype, as measured by Nu.

Q H3.1. This evidence positions the assay not just as a traditional rule in, out diagnostic, but as a dynamic tool for prognostic enrichment, for clinical monitoring, and most excitingly, as a potential therapeutic target. This study illustrates the advantages of an industry supported but independently conducted research model. Volition funded the H3.1 measurements but had no access to raw data and did not participate in the statistical analysis. This independence substantially enhances the credibility of the findings, especially in the eyes of regulatory authorities and peer reviewed journals.

The publication of this study in Critical Care, a high impact intensive care journal, confirms the scientific merit of our platform that paves the way for broader academic collaborations going forward. The objectivity of the data and the strength of the associations presented in this paper now provide a powerful platform for advancing regulatory filings under the IVDR framework, particularly for prognostic and monitoring claims. Substantial progress in our Nu. Q. NEXT pillar with lots more to come.

Thank you for listening. And with that, I’ll hand you over to Cameron. Thank you.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you, Andy, 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. As reported previously, we are in confidential discussions with over 10 companies, and I’m very happy with progress on many fronts. We are at various stages of negotiation across our different pillars, ranging from due diligence to tech transfer to evaluation of clinical samples, to term sheet discussioncompletion, and also to the contract finalisation stage.

Fantastic to see things moving through the funnel, albeit obviously confidentially at this stage. Notably, these are not small companies. The combined market value of seven of these companies exceeds $600,000,000,000 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 diagnostic space, mirroring our successful strategy in the veterinary space 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, including as a biomarker of interest to epigenetic drug development and ever expanding area of focus for big pharma. Cancer and sepsis diagnostics alone represent a combined total addressable market opportunity of approximately $25,000,000,000 annually, offering substantial revenue opportunities for Volition and our future partners. As a reminder, all the pillars are founded on materially the same mucousomic technology, which is effective in both cancer and sepsis for both human and animal health uses. Volition is a company powered by Nu. Q and focused on one theme: measuring chromatin fragments in circulation.

This one thing is the basis of all our pillars. We now can measure nucleosomes on around half a dozen different established collaborative platforms. The broad applicability of what we have developed is, I believe, totally unprecedented. Now, taking each pillar in turn, I will start with cancer, a space which is certainly hotting up given the recent exact Phenome deal. We are making significant strides in the commercialization of our cancer diagnostic pillar.

From a licensing perspective, I’m very 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 CapturSeq 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 rapidly. And I’m delighted that the National Taiwan University Hospital team will present interim analysis at the European Society of Medical Oncology Congress in October.

Positive findings would position our Nu. Q test for inclusion in the national lung cancer screening programs, representing a potential market exceeding $1,000,000,000 annually across Taiwan, U. S, U. K, and France alone. And this could be implemented relatively quickly in several countries where Mu2 cancer could be made available as a lab developed test, an LDT, with no need for further regulatory studies.

But we may seek a combination of LDT and regulated products in different markets. As Andy discussed, we’re also making strong progress with other potential use cases for Nu. Q lung cancer, in particular as an aid to personalised care by way of treatment selection and in detecting minimal residual disease. We are also making significant headway in the commercialisation of Nu. Q Nets.

The first prong of our Nu. Q Nets commercial strategy is to leverage our granted CE Marked product approved in The EU for any NETosis related diseases. Just as a reminder, Volition’s chemiluminescent immunoassay, clear version of the CE Mark MuQ test, or NET, is run on the IDS i10 Automated Analyzer platform from IDS, a subsidiary of Revity. I’d like to thank IDS for their collaborative, supportive approach. We are currently selling this product, both directly and in conjunction with IDS, to institutions for use in the very wide range of clinical applications where NETs plays a critical role.

In a very significant commercial milestone, we recorded our first revenue from sales of our CE Mark Nu. Q NETs automated product in Europe in Q1 of this year, and sales have continued in the second quarter. This is our first revenue generated from a regulated, clinically approved product in humans. We are very excited that 11 hospital networks in five countries have placed orders and are currently assessing its clinical utility in a range of NET applications, with the intention, we believe, of integrating it directly into their routine patient care. In addition, we are in discussions with more than 10 other hospital networks, with several evaluations anticipated to start in the second half of this year.

In short, a number of hospital groups in a number of countries are buying our CD March products with a view to using it clinically in a diverse range of NET related uses. We absolutely delight with the level and breadth of interest that we have seen in the past few quarters, and we continue to receive more inbound inquiries. This is a great outcome for Volition. Customers buy kits, generating not only revenue, but also clinical data for a very wide range of NETosis use cases in humans. The CE Mark sales are one of the two pronged approach of Volition’s Nu.

Q Net sales. We expect that our C Mark test will start to be used in routine clinical practice with patients next year in The EU, and then expand to use worldwide through the expected global out licensing in Natosis, the other pong of our strategy. Licensing discussions are progressing well with several potential licensing companies who already successfully completed the tech transfer of our assay onto their platforms. As Andy outlined, our extensive clinical evidence supports the use of our Nu. Q Nest technology in a critical area sepsis.

But our negotiations and potential licensing agreements reach far beyond sepsis to other NETs related conditions. The total addressable market for the testing and monitoring of sepsis intensive care patients alone represents a $1,000,000,000 opportunity annually, offering substantial revenue opportunities for Volition and our future partners. We believe the total addressable market of our Nu. Q Net assay could be in excess of $10,000,000,000 annually, as the use cases expand far beyond sepsis. The range of potential clinical use cases where mitosis plays a role is extremely broad, equating

: to

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: 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 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. On a personal note, in the near future, I firmly believe that level of Nets is something we all should be tested for regularly by a simple low cost test. I, knowing what I do about the importance of NETs in so many conditions, would get tested with my regular blood work regularly.

I foresee a time in the not too distant future when the level of NETs in your system is measured as a standard health check. The level of interest in using our Nu. Q test is notable. Clinical use cases include coagulation, cardiac issues, renal disease, trauma, burns, autoimmune diseases, organ transplant, pregnancy management, and of course, the biggest being sepsis. We are at different stages of the out licensing process in humans and negotiations with a range of companies, and are very excited about the progress.

We look forward to announcing our first deal soon. 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 Antec, part of the Mars Science and Diagnostic 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 the IDS i10. I am delighted to report that the Fuji team have made great progress this second quarter in validating the test in house and are on track to launch the automated platform in the third quarter.

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 numbers of tests that will result from having our tests in annual pet wellness panels. Importantly, this automated 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 technology. 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 for discovery to market ready. Nu. Q Discover is built on proprietary nucleosome quantification technology. It is a valuable research tool for R and 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 US distributor, Diopharma, to providing services such as sample processing on-site in Belgium or 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. Nu. Q Discover is now serving over 20 clients worldwide, accelerating disease research and drug development across multiple therapeutic areas.

We have seen growing demand for our Nu. Q assays as exploratory biomarkers in third parties, multinational clinical trials, with multiple global clients placing repeat orders. The largest of these projects has projected revenue in hundreds of thousands of dollars for ongoing longitudinal Phase one2b study targeting completion next year. We’re delighted to support the pharmaceutical company’s clinical efforts in developing new drugs for the treatment of large unmet clinical need. Pharma companies are using Nu.

Q assays as exploratory biomarkers today, and if when they advance to companion diagnostic use, this could translate into high value, multi million dollar long term partnerships. The evidence to support this pillar has expanded significantly this quarter, not only with the publication of a peer reviewed paper demonstrating the Nu. Q platform’s versatility across biological samples and disease models, but also the issue of three application notes. Interestingly, we’re also actively exploring co marketing partnerships to meet the demand of our Nucle Discover platform we are seeing worldwide, and hope to be able to sign such a deal with a large industry player in the coming quarter. Our robust pipeline and ongoing service expansion suggests continuing strong Nu.

Q Discover revenue growth this year. In drawing to a close, I would just like to reiterate that 2025 is about ensuring licensing deals are signed in the human space, and we’re making very good progress on this. There is 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.

I believe we are close to signing our first, hopefully of many, out licensing deal in the human space. This will make a major milestone in our company’s path to commercialisation and the implementation of our business model. These next few quarters are hugely exciting for our company. I think it is very fair to say that we have now developed a technology platform that has already been a breakthrough in vet oncology, and we are demonstrating how we can also make a significant contribution to both human oncology and sepsis diagnosis and treatment, in addition to supporting PharmEpi drug development. We now have evidence to support the use of our Nu.

Q platform 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 of millions of people and animals worldwide. Our strategy to achieve this has been to raise as much non dilutive funding as possible, ramp revenues, reduce expenses, and sign commercial deals with large industry players.

Completing commercial deals for the 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. And we’ll now take your questions. Operator?

Conference Operator: Thank you. Our first question comes from the line of Justin Walsh with Jones Trading. Please proceed with your question.

Analyst: Hi, thanks for taking the question. Can you comment on which uses of the new Q platform have been attracting the most attention from potential partners in the human health space?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah, good question Justin. Actually, I’d have to say pretty much every area we’ve got, it’s been fifteen years now when we dreamt big that we could get a platform that is very useful in a very wide range of areas, and I think we’ve absolutely cracked it. So mean, you go through all of them, the Discover side, we’ve got over 20 clients now, including the world’s biggest companies, so a lot of excitement there. In Natosis, as we talked about, the biggest diagnostic companies and also the large autoimmune and coagulation companies. And three of those have been now working on their platforms.

So a lot of interest in the NET space. And also our CE Mark kits are now being used by 11 different hospital networks in five different countries for 21 different use cases. You’d have to think that’s actually taken us by surprise how broad and quickly that’s taken off with our sales partners, IDS Revity. Then of course, the oncology space has actually, in this last quarter, come roaring back in a whole lot of areas. Obviously, there’s all the lung uses.

We expect all that data soon. So very big interest from the lung screening programs. Also, we’re in discussions with multiple large liquid biopsy companies about licensing a basic platform. So it’s been very large interest from that space. So I think you’d have to say it’s actually not coming from one area, but pretty much everything we do.

I think there’s a really big understanding now that what we do is incredibly important. Our platform is now stable and it’s all the things they want, low cost, easy to adapt to their platforms and can be rolled out worldwide quite easily. So that’s not an answer directly for which one, but I think you’d have to say at the moment it’s pretty much everything we’re doing is attracting a lot of interest.

Analyst: Great, thanks. Quick We do

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: believe we are very close to that first human out licensing deal, given the very wide range of discussions, including a few at the very final stage. So I do expect to close the first, which will be a massive milestone for us this quarter, which of course means this month or next because it’s September at the end of the quarter. Great.

Analyst: We’re looking forward to that. Maybe a quick follow-up. I’m just curious if you’re starting to see repeat customers as you’re making some of the sales of Nu. Q nets in Europe and they’re figuring out the best use cases there.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Absolutely, yes, very much so actually. Of those 11 networks, multiple of them now have ordered two or three times. They’re very much liking the adaptability of the tests and how well it works. So we’re getting a lot of repeat orders in Nu. Q Discover and Nu.

Q Nets, and actually a lot of people are also just buying the basic microtiter plates to do their own research as well. So if you take over 20 customers in the Nu. Q Discover group of companies, and also the 11 hospital networks on the C Mark kits, as well as all the ones we’re doing on the licensing, A very broad group and many of them are in multiple, some of them on the third or fourth reorders. Thanks for taking the questions. Thanks, Justin.

Take care.

Conference Operator: Thank you. Our next question comes from the line of Jason Kolbert with D. Borel Capital. Please proceed with your question.

Analyst: Hi, guys. Congratulations on the progress. Thank you. As you execute a deal and you bring real capital into the company, how do you use that capital and how does it help you to drive revenues, for example, on the new Cube Vet?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Yeah, so ultimately, our goal is to become revenue neutral, as Terry has pointed out, and that’s all the things he said on the call. We are expecting each deal is going to be different, as in the Vet space, in the net space as well as the discover space and the vet space and the human space. We’re looking to sign a wide range of deals. In the Natosa space, for example, there are 21 different use cases now. So the deals we expect on the sepsis side, we do expect very large payments and ongoing revenues.

Some of the use cases in coagulation and the autoimmune diseases are smaller indications, so we will not be expecting very large checks. But any one of the deals, if they’re spending millions of dollars to launch a product on our intellectual property, it’s a very good thing for us. I think it helps on the revenue side, but also given the number of negotiations we have once we sign the first deal, it also gives everyone else a good nudge to keep those negotiations moving. And as we said, we have a lot going through the space. The next big thing is in the vet space you mentioned specifically, I think we are close, or Fuji are close to their independent validation of the centralized lab to get the i10, the same machine we use in the human space, working in centralized labs in vet.

That would be the time when I think it can allow it to be in wellness panels for dogs, which would then potentially move to those large amounts of tests we all want, the millions of tests, not the 100,000 right now. So that’s progressing very well. We’re also closing in Thank on the

Analyst: you. That’s very helpful. Thank you. Okay. Congratulations on the progress.

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

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

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

Conference Operator: Mr. Chen, it seems you’re on mute.

: Sorry about that. Thank you for taking my question. Could you provide some color on the indication or application of the first human deal? And also, going forward for all those human application deals, do you expect the deals to be mutually exclusive in terms of application or indication?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: A very good question. So we haven’t given the details on what the first deal is in the department. You’ll find it out when they’re released. Obviously there’s confidentiality until they’re finished. But to give some flavor to them all, all of them are dependent on the use of our test.

Our test is now robust, reproducible, reliable. It’s been shown, as Doctor. Redder so well pointed out, in many, many different use cases. So in every deal we expect to get the upside. In every deal we expect them to do the work, to get the regulatory work done, launch the product.

So if you think of it this way, they’re building on our land and then they have to pay us for every process. We are working on some very large deals. We’re also working on some deals on smaller indications, still very important indications where there are millions of people afflicted by that particular area worldwide. Some of those will have smaller milestone payments, some will have bigger ones, but all will give us ongoing revenue. We won’t be specific to what they are until they’re released, of course, for obvious reasons.

We’re also looking at deals to help us co market, for example, the Discover space. Those contracts can be quite large, but we don’t want to hire a large sales force in the Discover space as we have not in the NETs or the oncology space. We’re probably closer to be able to outline the terms, for example, with the national screening programs in lung cancer. We’ve talked about the potential market being millions of tests per year just in the countries we’re working in now. We look to be getting up to about $50 per test in those countries, on if it’s direct sales or through partners.

So obviously those are very large deals and potentially are closer because the final data is now being worked on. So as we said, we are expecting deals in the short term and would expect a steady streamer of them through to the end of next year as we get all these deals done. But our intellectual property is very strong. I think our use cases are very broad and very valuable. So each deal will be a bit different and we’re not afraid of doing very large deals and deals which also make sense just in the smaller numbers of millions of dollars potential revenue per year.

But I think as a package, they’ll be very attractive to our partners and to our shareholders.

: Thank you. And I have a follow-up question. Could you provide some rough estimates as to the length of time required for your customers typically between licensing the deal to commercialization?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: That’s very good question. So obviously in the co market you can discover it would be straight away. We’d be selling the kits and processes immediately. In the vet space it’s also quite much more immediate because of the regulatory process. The CE marked kits are currently CE marked, not surprising.

So we’re selling human kits now, so we have revenue from that today, and we expect that to steadily grow through next year as they go from selling kits for them to complete the cut offs for their own use cases. And as we said, there’s 21 of those we know of now. So we’d expect that through next year. Ones where they have to adapt it to their platform, a lot of those have already done that. That typically takes six to twelve months, but many of those have been done already.

And then a regulatory path for either CE Mark or FDA takes between two to three years depending on the process. The CE Mark IVDR takes about two years. We’d expect the FDA to take about three years, as from what we understand, it is a five ten. And for the moment, on the IVDR, it’s a Class B. We’re So looking more two years than sort of three or four or five, but the FDA can take a little longer than that.

Short answer is, from some of them it’s immediate revenue from the process at the back end it’s more like three or four years. And just to reiterate, the big areas in the NETs case are COVID and sepsis, as we all know, all the autoimmune diseases associated with NETs, which are a very large number, and coagulation. Also, they’re doing a lot of work in things organ rejection, burns, trauma, all different uses. So from today to about three to four years is the different timelines it would take them.

: Thank you. That’s very helpful.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thanks for your time.

Conference Operator: Thank you. Our next question comes from the line of Bruce Jackson with The Benchmark Company. Please proceed with your question.

Analyst: Hi, good morning, thanks for taking my questions. Just two follow ups on the clinical programs. With the Taiwan screening program, let’s say that they did decide to implement this. Are they prepared to scale that type of a program? And do you have the test on a high volume analyzer right now to do that

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: in Yes. So the trials are currently being done in Taiwan, are the final validation study. So hopefully that data continues on with the great results we’ve got, and they’ve worked on cross validation between France and Taiwan, which also worked well. So it is on that machine, which would be the machine they’d launch. There are two methods of launching in Taiwan, like anywhere else.

You can do it in a clear lab, which we would potentially expect that to be particularly for the central region around Taipei. You can also go for Taiwanese FDA to make it more of a product, which we’re reviewing now as to the availability, whether it’s worth doing that. But I think most likely we’d go for a mixed combination of some Clear Labs to get the early revenue and get it out there quickly, and then more of a product. The Taiwanese FDA process would take something around twelve months from what we can tell. So yes, it’s currently on the machine.

No, we don’t need any more tech transfer. Yes, they’re interested in launching it as a clear lab. The clear lab running the current process is very closely associated with the national program, so that could be done quite quickly. So if it went well, we’d expect it could be on the market and generating revenue in the first half of the next year. That’s also obviously dependent on the data and the process, but it’s something that could happen quite quickly.

And we could, if we decided to go that route as well, have it approved by the TFDA as early as the end of next year as a more of a general uptake for any lab or process anyone running the test in Taiwan. On the French side, we’re working with the National Screening Programme as well. It’s currently on the machine again, the Revity machine, so that could be done. They would want to do a validation study similar to what’s being done in Taiwan. So I think the earliest we would be in any part of the national screening program of France would be the next year, 2027.

But the next step would be to sign up for a validation study in Taiwan, in France as we have in Taiwan, and we’re hoping to have news on that this year. So it starts running by the end of this year, and we can do the implementation next year to be part of some regions of the French program by 2027.

Analyst: Okay. And then in Taiwan, in addition to the Taiwanese FDA, are there any other regulatory or guideline bodies that would need to sign off on using the test before it went into full production?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: So it is on the current machine. This is the validation study. It’s in the lab that could be done. So that we’re aware of currently, and we’re in the process. So it’s been worked on very closely with the people doing our trials, Professor Yu and obviously Doctor.

Quay, our Head of Asia, has done a lot of work on this. She was actually there last week and going back again in August with our scientific team. But it’s plausible that if the trial goes well, which is what we expect, but you never know, the data has been very good so far, It could be launched in a clear lab setting and generating us direct sales revenue potentially of around $50 per test. We’re working with them now on that directly to Volition. So it could be something which becomes a big part of our revenue story next year if it continues to go as well as it has.

Analyst: Okay. And then my second line of question is around the lateral flow test for NETs. You did a I guess it was a proof of concept type of study. Was that an internally developed platform or did you work with a partner on that?

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: We haven’t disclosed who the partner, but we worked with several partners on the lateral flow. And it worked very well on venous blood and we’re now working through capillary blood. But we’re extremely happy with the way HAT’s gone and it’s also a quantitative test in the very good range for the ptosis up into very, very high levels. So we, as in the vet space, we think the centralized labs are probably the biggest market. But if you want to have hundreds of millions of tests sold worldwide, having a lateral flow and a point of care are very, very helpful.

And that is something else like the lung program we could potentially keep as direct sales because it doesn’t directly compete with our partners. A hospital will much more likely want just something as a routine blood test that goes to the central lab and comes back. But if you want a take home test or in developing countries or a range of other use cases, we think that could be a very attractive market for the lateral flow as well. So very excited that worked as well as it did. We should have some more news on that later this year and we are working with external partners and contractors, not people we’re directly licensed to.

Aim to keep that for ourselves and be able to sell that directly ourselves as we have in the lung program directly to customers. And the cost of goods typically on those tests are in the very small number of dollars, like $1 or $2 to make, so potentially it’s a very lucrative addition to our revenue stream in the coming years.

Analyst: Okay, great. That’s it for me. Thank you.

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

Conference Operator: Thank you. Ladies and gentlemen, that concludes our question and answer session. I’ll turn the floor back to Mr. Reynolds for any final comments.

Cameron Reynolds, Group Chief Executive Officer, VolitionRx Limited: Thank you very much for your time. It’s been a very interesting quarter and I think the back half of the year should be very interesting as we cement our first out licensing in the human space and hopefully get a lot more data through all of our oncology and discover as well as the Nets platform. It’s been fifteen years now. We really dreamt big to get a platform that’s robust, reliable and useful in a very wide range of areas where measuring chromatin fragments can be useful. But I have to say, it’s happened beyond what we could have dreamed of early on with the addition of Natosis to all the oncology markers and also moving into the animal space.

So keep track of all the things we’re doing. There’s a lot happening all on the same platform. We should have a look to update you on in the coming weeks and months as we deliver on the licensing, as well as all the other areas we’re doing. So thank you very much for your time, and I look forward to updating you all as this all comes through. Thank you.

Conference Operator: Thank you. This concludes today’s conference call. You may disconnect your lines at this time. Thank you for your participation.

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