Volitionrx Ltd Q2 FY2025 Earnings Call

Good morning, everyone, and thank you for joining us. Welcome to VolitionRx Limited's Second Quarter 2025 Earnings Conference Call. This conference is being recorded today, August 15, 2025. I will now hand the call over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please proceed.

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 of 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 non-invasive 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 at 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 the 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 refer 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 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.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 that 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 reflect 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 nucleosomic 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 heating 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 are 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, the 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 the 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 have 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 the 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 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&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 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 for 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 suggest 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 mark 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 for 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.

Our first question comes from 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. I can confidently say that nearly every area we've explored has shown promise. It's been 15 years since we envisioned a platform that would be beneficial across a wide variety of fields, and I believe we've achieved that. For instance, in the Discover segment, we now have over 20 clients, including some of the largest companies in the world, which has generated a lot of excitement. In NETosis, we've been collaborating with major diagnostic firms as well as large autoimmune and coagulation companies, three of which are actively working on their platforms. Interest in the NETs area is quite strong. Additionally, our CE-marked kit is being utilized by 11 hospital networks across five countries for 21 different use cases. The rapid expansion and breadth of this have pleasantly surprised us, thanks in part to our sales partners, IDS and Revvity. Moreover, this past quarter, the oncology segment has experienced significant growth across various areas. We anticipate receiving data on lung uses soon, and there's considerable interest from lung screening programs. We're also in talks with several large liquid biopsy companies about licensing our core platform, indicating robust interest from that sector. Overall, it’s not just one specific area that is attracting attention; almost everything we’re doing is gaining recognition for its importance. Our platform is stable and meets the demand for being low-cost, easily adaptable, and suitable for global rollout. While I can't point to one specific area, I can say that almost everything is generating a lot of interest. Furthermore, we strongly believe we are on the verge of securing our first human out-licensing deal, having engaged in a wide range of discussions, some of which are in the final stages. I expect to finalize this deal, which would be a significant milestone for us, by the end of this quarter, meaning either this month or next, as the quarter ends in September.

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?

Yes, we are seeing significant interest from our 11 networks, with several of them placing multiple orders. They appreciate the versatility of the test and its effectiveness. This has led to a number of repeat orders for both Nu.Q Discover and Nu.Q NETs. Additionally, many customers are purchasing the basic microtiter plates for their own research. Overall, we have over 20 customers in the Nu.Q Discover sector and also 11 hospital networks utilizing the CE-marked kits, along with those we're working with on licensing. It's a diverse group, and many of them are already on their third or fourth reorder.

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 drive revenues, for example, on the Nu.Q Vet?

Yes. Our ultimate goal is to achieve revenue neutrality, as Terig has indicated. Each deal we pursue will be unique across various sectors, including veterinary, NETs, and human health. We aim to sign a diverse array of agreements, particularly in the NETosis area, where we currently have 21 different use cases. For the sepsis deals, we anticipate significant payments and continuous revenue. While some indications in coagulation and autoimmune diseases may lead to smaller deals, any agreement involving substantial investments in our intellectual property is beneficial. This not only supports our revenue but also encourages progress in other negotiations. We have many discussions underway, particularly in the veterinary field. I think we're nearing the independent validation of the centralized lab for our i10 machine in that sector. This advancement could lead to the inclusion of wellness panels for dogs and potentially scale our testing operations from hundreds of thousands to millions. Progress is moving along well, and we're also finalizing additional efforts in our various licensing initiatives.

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

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?

Thank you for your question. We haven’t disclosed details about the first deal yet, and confidentiality will remain in place until everything is finalized. However, I can share that all deals are tied to the use of our test, which has proven to be robust, reproducible, and reliable across various use cases. We anticipate benefiting from every deal, as we expect them to complete the necessary regulatory work and launch their products. Essentially, they will be utilizing our resources and compensating us for each process involved. We are exploring several significant deals, as well as opportunities in smaller indications that still affect millions globally. Some will yield smaller milestone payments, while others could be more substantial, but all should contribute to ongoing revenue. We cannot provide specifics on these until they are officially announced. Additionally, we are considering partnerships for co-marketing, particularly in the Discover space, where large contracts can be beneficial; however, we prefer not to expand our sales force significantly in that area, similar to our approach in NETs and oncology. We are getting closer to outlining terms for some national lung cancer screening programs, with the market potential being millions of tests annually in the countries we are currently involved with. We expect to achieve around $50 per test in those markets, whether through direct sales or partners. These represent substantial deals and we are progressing with final data collection. As mentioned, we expect several deals in the near term and anticipate a steady stream of them until the end of next year as we finalize these agreements. Our intellectual property remains strong, and the use cases are extensive and valuable. Each deal will have its unique characteristics, but we are open to pursuing both large and smaller deals that can bring in millions of dollars annually. Overall, I believe this package will be appealing to both our partners and 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. In the co-marketing Discover, we will begin selling the kits and processes right away. In the veterinary space, the process is more immediate due to regulatory requirements. The CE-marked kits are already compliant, so we're currently generating revenue from human kits and anticipate steady growth in that area next year as customers start using them for their specific needs. There are currently 21 known use cases, and we expect developments throughout next year. Many customers have already adapted the kits to their platforms, which usually takes 6 to 12 months. The regulatory path for CE marking or FDA approval typically lasts 2 to 3 years, with the CE mark IVDR taking around 2 years and the FDA process taking about 3 years under the 510(k) classification. In the case of IVDR, it's a Class B, so 2 years is more likely than 3 or 4. However, the FDA process might extend beyond that. In summary, some of our products will generate immediate revenue, while others could take 3 to 4 years. Key areas of focus include COVID, sepsis, various autoimmune diseases linked to NETs, coagulation, organ rejection, burns, and trauma. The timelines for these range from today up to about 3 to 4 years.

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?

The trials currently underway in Taiwan are the final validation study. We hope the data continues to show great results. They've successfully conducted cross-validation between France and Taiwan. This is taking place on the machine that we plan to launch. There are two methods for launching in Taiwan. One option is to do it in a CLIA lab, which we expect to focus on the central region around Taipei. The second option is to pursue approval from the Taiwanese FDA to establish it as a product, which we are currently assessing. We likely will use a combination of some CLIA labs for early revenue and a subsequent product rollout. The Taiwanese FDA approval process is estimated to take about 12 months. The machine is ready, and no further tech transfer is needed. There is interest in launching it in a CLIA lab, as the current lab is closely linked to the national program, allowing for a quick implementation. If successful, we could see it on the market generating revenue in the first half of next year, although that depends on data and the process. If we opt for FDA approval, it could be granted as early as the end of next year for broader access in Taiwan. We are also collaborating with the national screening program in France. The machine is ready there as well, and they wish to conduct a validation study similar to the one in Taiwan. The earliest we could be involved in any part of the French national screening program would be by 2027. The next step is to sign up for a validation study in France, mirroring what we've done in Taiwan, and we expect to have updates on that this year to begin running by year-end, with implementation planned for next year to be part of 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 Taipei, 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 generate 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. My second question is about the lateral flow test for NETs. You conducted a proof-of-concept study. Was that platform developed in-house, or did you collaborate with a partner?

We haven't disclosed the names of our partners, but we collaborate with several on the lateral flow tests, which performed well with venous blood, and we are now focusing on capillary blood. We are very pleased with the progress, and it also serves as a quantitative test for NETosis, demonstrating very high levels. In the veterinary sector, we believe that centralized labs represent the largest market. However, for widespread testing globally, lateral flow and point-of-care tests are incredibly valuable. Similar to our lung program, we may opt for direct sales since it wouldn't directly compete with our partners. Hospitals are more likely to prefer routine blood tests sent to central labs, but the take-home tests could cater to developing countries and other specific needs, making the lateral flow market very appealing. We are thrilled with its success so far and expect to share more updates later this year. Our work with external partners refers to contractors, and we plan to retain direct sales for ourselves without licensing to others, similar to our lung program sales strategy. The production cost of these tests is quite low, typically around $1 or $2, making it a potentially lucrative addition to our revenue 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.