VolitionRx Limited (VNRX) Q2 2025 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Second Quarter 2025 Earnings Conference Call. [Operator Instructions] This conference is being recorded today, August 15, 2025. I'd now like to turn the call 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, our Chief Financial Officer, will open the call with a full financial report before handing over to Dr. 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 Terig.

Thanks, Lou, and thank you, everybody, for joining Volition's Second 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. 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 second quarter of 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 $6.3 million for the second quarter 2025, compared to $6.7 million in quarter 2 of 2024. For the first half of 2025, net cash used in operating activities totaled $10.6 million, down 30% over the same period prior year. Revenue-wise, we recorded over $400,000 of revenue in the quarter, bringing the first half 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 NETs, 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 $2.3 million, compared to $3.3 million at the end of 2024. Receipts during the second quarter included $6 million in net proceeds from a convertible loan note. Subsequent to quarter end, we also received $1.2 million 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?

Thank you, Terig, and good morning, everybody. I'm very pleased with the incredible progress we have made from our innovation scientific and clinical perspective 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 Civils 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 our poster session at the recent European Lung Cancer Congress, interim analysis of 832 patients showcased that Nu.Q H3K27 trimethyl is a strong prognostic marker in non-small cell lung cancer. H3K27 is a noninvasive biomarker that complements circulating tumor DNA and predict survival regardless of the patient's cancer mutation status. These were exciting results confirming earlier studies showing that H3K27 nucleosome levels of diagnosis could help inform treatment decisions and patient monitoring, thereby facilitating personalized 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, Gael Forterre, are working to facilitate early adoption of this test, and we are very happy with the progress on commercialization. Another long-term collaborator is the National Taiwan University team who continue to enroll 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 end of 2025. We and indeed, the team at NTU believe our groundbreaking Nu.Q 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 Nu.Q test may be considered for use in combination with any national lung cancer screening programs, not just limited to Taiwan. While accurate screening could lead to a greater uptake of screening by patients, and greater adoption of lung cancer screening programs by governments across the world. This, in turn, should lead to lung cancer being diagnosed earlier and saving many, many lives. Lung cancer remains the #1 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 Nu.Q Cancer, please [ could I signpost ] you to a recent report available on our website, Hope for a Brighter Tomorrow. It is an informative read highlighting the potential use of Nu.Q across the disease time line. 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.Q NETs 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 that 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 the Nu.Q H3.1 is a clinically meaningful, biologically specific marker of NETosis, with actionable 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 reflects the biological process, 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 NETosis 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/rule-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 NETs pillar with lots more to come. Thank you for listening. And with that, I'll hand you over to Cameron. Thank you.

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 discussion/completion, and also to the contract finalization 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 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 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, an ever-expanding area of focus for big pharma. Cancer and sepsis diagnostics alone represent a combined total addressable market opportunity of approximately $25 billion annually, offering substantial revenue opportunities for Volition, and our future partners. As a reminder, all the pillars are founded on materially the same [ nucleosemic ] 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 thing, 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 collaborators' 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, Freenome 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 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 rapidly. And I'm delighted that the National Taiwan University Hospital, NTU, 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 billion annually across Taiwan, U.S., U.K. and France alone. And this could be implemented relatively quickly in several countries where Nu.Q 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 are also making strong progress with other potential use cases for Nu.Q lung cancer. In particular, as an aid to personalized care by way of treatment selection and in detecting minimal residual disease. We are also making significant headway in the commercialization 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-marked Nu.Q test, for NETs is run on the IDS i10 automated analyzer platform from IDS, a subsidiary of Revvity. 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-marked 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 5 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 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 CE-marked products with a view to using it clinically in a diverse range of NETs-related uses. We're absolutely delighted 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 marked sales are one of the two-pronged approach of Volition's Nu.Q NETs sales. We expect that our CE marked 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 out-licensing in NETosis, the other prong of our strategy. Licensing discussions are progressing well with several potential licensing companies, who already successfully completed the tech transfer of our asset onto their platforms. As Andy outlined, our extensive clinical evidence supports the use of our Nu.Q NETs 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 billion opportunity annually, offering substantial revenue opportunities for Volition, and our future partners. We believe the total addressable market of our Nu.Q NETs assay could be in excess of $10 billion annually, as the use cases expand far beyond sepsis. 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 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 our 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 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 Antech, part of the Mars Science & 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'm 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 the 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, the 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 the 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&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, through 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 I/IIb study targeting completion next year. We are delighted to support the pharmaceutical companies' 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, multimillion-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 Nu.Q 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 the 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 commercialization 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 pharm-epi 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?

[Operator Instructions] Our first question comes from the line of Justin Walsh with JonesTrading.

Can you comment on which uses of the Nu.Q platform have been attracting the most attention from potential partners in the human health space?

Yes. Good question, Justin. Actually, I have to say pretty much every area we've got. It's been 15 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're absolutely cracked it. So I mean if 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 NETosis, 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 NETs space. And also our CE marked kit has now -- are now being used by 11 different hospital networks in 5 different countries for 21 different use cases, you'd have think -- that's actually taken us by surprise how broad and quickly that's taken off, with our sales partners there, IDS, Revvity. Then of course, the oncology space has actually, in this last quarter really roaring back in a whole lot of areas. Obviously, there's all of 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 our basic platform. And so it's been a 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 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. And to reiterate -- we do 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 -- end of September is the end of the quarter.

Great. 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 you're figuring out the best use cases there?

Absolutely, yes, very much so, actually. Of those 11 networks, multiple of them now have ordered 2 or 3 times. They're very much liking the adaptability of the test 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 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 in the CE marked kits as well as all the ones we're doing in the licensing, a very broad group. And yes, many of them are in multiple -- some of them on the third or fourth reorders.

Our next question comes from the line of Jason Kolbert with D. Boral Capital.

Congratulations on the progress. 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 kind of drive revenues, for example, on the Nu.Q Vet?

Yes. So ultimately, the -- we are -- our goal is to become revenue neutral as Terig has pointed out, and that's -- and all the things he said on the call. So we are expecting each deal is going to be different as in the vet space. In the NETs 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 NETosis 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. And 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 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 vets. That would be the time when I think it can allow it to be in wellness panels for dogs, which would then, I think, potentially move to those large amounts of tests we all want, the millions of tests, not that 100,000 we're at now. So that's progressing very well. We're also closing in on the...

Congratulations on the progress.

Our next question comes from the line of Yi Chen with H.C. Wainwright.

Could you provide some color, 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?

Very good question. So we haven't given the details on what the first deal -- you'll find 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 Dr. Retter 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 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 areas 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 released, of course, for obvious reasons. We're also looking at deals to help us co- market, for example, in 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, depending on if its 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 stream 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 the 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 makes 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.

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?

That's a very good question. So obviously, in the co-marketing Discover, it would be straight away with that we'll 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 once -- 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 cutoffs 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 6 to 12 months, but many of those have been done already. And then a regulatory path for either CE mark or FDA takes between 2 to 3 years depending on the process. The CE mark IVDR takes about 2 years. We'd expect the FDA to take about 3 years as from what we understand, it is a 510(k). And for the moment on the IVDR, it's a Class B, so we're looking more 2 years than sort of 3 or 4 or 5. But the FDA can take a little longer than that. But -- so short answer is from some of them, it's immediate revenue from the process, at the back end, it's more like 3 or 4 years. And just to reiterate, the big areas in the next 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 3 to 4 years is the different time lines that would take them...

Our next question comes from the line of Bruce Jackson with The Benchmark Company.

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 in Taiwan?

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'll launch. There are two methods of launching in Taiwan like anywhere else. You can do it in the CLIA 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 CLIA labs to get the early revenue and get it out there quickly, and then more of a product. And the Taiwanese FDA process would take something around 12 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 in a CLIA lab. The CLIA lab running in 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. That is 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 in -- or any process -- anyone running the test in Taiwan. On the French side, we're working with the national screening program as well. It's currently on the machine, again, the Revvity 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, as we have -- sorry, 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 this -- some regions of the French program by 2027.

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

So it is on the current machine. This is the validation study. It's in the lab that could be done. So not 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 in [indiscernible] and obviously, Dr. Kway, our Head of Asia, has done a lot of work on this. She's 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, but the data has been very good so far. It could be launched in a CLIA lab setting and get -- 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.

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?

We haven't disclosed who are the partners, but we work 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 that's gone, and it's also a quantitative test in the very good range for NETosis, up into 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. So -- 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 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 -- so external partners, we mean contractors, not people would directly license to. We 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 in a very small number of dollars, like $1 or $2 to make. So potentially, it's very lucrative addition to our revenue stream in the coming years.

Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Mr. Reynolds for any final comments.

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 15 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. And I have to say it's happened beyond what we could have dreamed of early on with the addition of NETosis to all the oncology markets, 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, and we should have a lot 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.

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