Q2 2025 VolitionRx Ltd Earnings Call

Speaker #1: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Ltd's second quarter 2025 earnings conference call. During today's presentation, all parties will be in a listen-only mode.

Speaker 1: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited's second quarter 2025 earnings conference call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be open for questions. If you have a question, please press the star key followed by the number one on your touch-tone phone. If you would like to withdraw your question, please press the star key followed by the number two. If you are using speaker equipment, please lift a handset before making your selections. This conference is being recorded today, August 15th, 2025. I would now like to turn the call over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.

Speaker #1: Following the presentation, the conference call will be open for questions. If you have a question, please press the * key followed by the number 1 on your touchtone phone.

Speaker #1: If you'd like to withdraw your question, please press the * key followed by the number 2. If you're using speaker equipment, please lift the handset before making your selections.

Speaker #1: This conference is being recorded today, August 15th, 2025. I'd now like to turn the call over to Louise Batchelor, Group Chief Marketing and Communications Officer.

Speaker #1: Please go ahead.

Speaker #3: Thank you. And welcome, everyone, to today's earnings conference call for VolitionRx Ltd. 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.

Louise Batchelor: Thank you, welcome everyone to today's earnings conference call for VolitionRx Limited. Before we begin, I would 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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 findings with the Securities and Exchange Commission.

Louise Batchelor: 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. With that, I will turn the call over to Terig.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: And with that, I'll turn the call over to Terig.

Speaker #4: 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.

Terig Hughes: Thanks, Lou, and thank you everybody for joining VolitionRx Limited'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 diagnostics space with significant upfront payments, receiving certain milestone payments in the vet space, and reducing our spend. I am happy to report we continue to make solid progress against each of these targets, and Cameron Reynolds 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: As a result of strong cost management, net cash use in operating activities was $6.3 million for the second quarter of 2025, compared to $6.7 million in the second quarter of 2024.

Terig Hughes: As a result of the strong cost management, net cash use in operating activities was $6.3 million for the second quarter of 2025, compared to $6.7 million in Q2 of 2024. For the first half of 2025, net cash use 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 of total revenue recorded to a little over $650,000. Total revenue was up 15% in the first half, and I am also delighted we recorded the first revenue for sales of a human product, Nu.Q® NETs, a great milestone.

Speaker #4: For the first half of 2025, net cash used in operating activities totaled $10.6 million, down 30% compared to the same period in the prior year. Revenue-wise, we recorded over $400,000 in revenue for the quarter, bringing the total revenue for the first half to a little over $650,000.

Speaker #4: 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, NuQ Nets—a great milestone.

Speaker #4: 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. Therefore, we will not be providing revenue guidance for 2025 at this point in time.

Terig Hughes: 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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.

Terig Hughes: 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 Reynolds will expand on later, we made great progress in advancing our licensing discussions. With that, I will pass over to Dr. Andrew Retter for a summary of recent achievements in our clinical study program. Andy?

Speaker #4: And with that, I will pass over to Andy for a summary of recent achievements in our clinical study program. Andy?

Speaker #5: Thank you, Terig, and good morning, everybody. I'm very pleased with the incredible progress we have made from our innovative scientific and clinical perspectives across both NuQ Cancer and NuQ Nets pillars, and indeed some of the exciting work we have completed and have ongoing in our NuQ Discover pillar.

Dr. Andrew Retter: Thank you, Terig, and good morning, everybody. I am very pleased with the incredible progress we have made from our innovations, 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 Séville in Lyon, France, and I would 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.

Speaker #5: 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.

Speaker #5: In terms of NuQ Cancer, one of our key collaborators is the Hospice for Severe in Lyon, France, and I'd like to start by discussing some of their recent research, which looks at the use of NuQ through the patient's cancer journey.

Speaker #5: 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.

Dr. Andrew Retter: As a reminder, their initial study was published in 2023, but two manuscripts are currently in development for publication. During a 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 predicts survival regardless of the patient's cancer mutations 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 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, Gaëlle Forter, are working to facilitate early adoption of this test, and we are very happy with the progress on commercialization.

Speaker #5: During a poster session at the recent European Lung Cancer Congress, an internal analysis of 832 patients showcased that NuQ, H3K27 trimethyl, is a strong prognostic marker in non-small cell lung cancer.

Speaker #5: 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 patient monitoring, thereby facilitating personalized care.

Speaker #5: This study is now being written up, with plans to submit for peer review in the coming months. The commercial team, led by Chief Commercial Officer Gaël Forterre, is working to facilitate early adoption of this test.

Speaker #5: 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.

Dr. Andrew Retter: 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 VolitionRx Limited. We are 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 patient 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.

Speaker #5: Which has been funded by the Wulun region. We're aiming for 500 patients, and the study is due for completion by the end of 2025.

Speaker #5: We, and indeed the team at NTU, believe our groundbreaking NuQ Cancer tests could support physicians with clinical decision-making following low-dose CT scans. By enabling them to identify the patient's 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, we can avoid unnecessary biopsies.

Speaker #5: If the findings of this final 500-patient study align with the previous results, the NuQ test may be considered for use in combination with any national lung cancer screening programs.

Speaker #5: 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 programs by governments across the world.

Dr. Andrew Retter: More 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 number one cancer killer worldwide. The NTU team are on track to present interim findings at the European Society for Medical Oncology meeting, ESMO, in Berlin in October. Our Chief Scientific Officer, Jake, is heading over to Taiwan with several other VolitionRx Limited 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.

Speaker #5: This, in turn, should lead to lung cancer being diagnosed earlier and save many lives. Lung cancer remains the number one cancer killer worldwide.

Speaker #5: The NTU team is 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.

Speaker #5: This reflects great progress, indeed. For more information about NuQ Cancer, please could I signpost you to a recent report available on our website. Hope for a brighter tomorrow.

Speaker #5: It is an informative read, highlighting the potential use of NuQ 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.

Dr. Andrew Retter: 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. From a Nu.Q® NETs perspective, we were delighted that our large independent study conducted by the Marv Consortium was peer-reviewed and published in the second quarter. In this large observational study, we demonstrated that plasma nucleosomes represented by Nu.Q® H3.1 nucleosome concentration are associated with the presence of sepsis, the severity of organ dysfunction, and a hyper-inflammatory host response.

Speaker #5: We are excited to publish this further validation of our NuQ platform. It represents a significant potential opportunity to disrupt the liquid biopsy market for multi-cancer early detection.

Speaker #5: Now, from a NuQ Nets perspective, we were delighted that our large independent study conducted by the Mars Consortium was peer-reviewed and published in the second quarter.

Speaker #5: 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 hyper-inflammatory host response.

Speaker #5: This study demonstrates and confirms that NuQ H3.1 is a clinically meaningful, biologically specific marker of mitosis, with actionable potential in defined subgroups. Patients with acute kidney injury, disseminated intravascular coagulation, and acute respiratory distress syndrome exhibit significantly higher NuQ H3.1 levels compared to those patients without these conditions.

Dr. Andrew Retter: This study demonstrates and confirms that Nu.Q® H3.1 is a clinically meaningful, biologically specific biomarker of mitosis with actional 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 mitosis, 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 mitosis can be treated and modified in patients with a high mitosis phenotype, as measured by Nu.Q® H3.1.

Speaker #5: As I have mentioned on previous calls, H3.1 nucleosomes reflect the biological process of mitosis, supporting the emerging concept of treatable traits and biologically informed risk stratification to facilitate and enhance patient care.

Speaker #5: The implications of our results are that mitosis and H3.1 nucleosomes, in particular, play at the intersection of infection, organ failure, and inflammation. They are not simply a surrogate marker of these conditions.

Speaker #5: This opens up the opportunity of identifying how excessive mitosis can be treated and modified in patients with a high mitosis phenotype, as measured by NuQ H3.1.

Speaker #5: This evidence positions the assay not just as a traditional roll-in, roll-out diagnostic, but as a dynamic tool for prognostic enrichment, for clinical monitoring, and, most excitingly, as a potential therapeutic target.

Dr. Andrew Retter: 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. VolitionRx Limited 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 and 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.

Speaker #5: 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.

Speaker #5: 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 and paves the way for broader academic collaborations going forward.

Speaker #5: 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.

Speaker #5: Substantial progress in our NuQ Nets pillar, with lots more to come. Thank you for listening, and with that, I'll hand you over to Cameron.

Dr. Andrew Retter: Substantial progress in our Nu.Q® NETs pillar, with lots more to come. Thank you for listening, and with that, I will hand you over to Cameron Reynolds. Thank you.

Speaker #5: Thank you.

Speaker #6: Thank you, Andy, and good morning, everyone. 2025 is a pivotal year for Volition as we focus on commercializing our groundbreaking NuQ platform in the human diagnostic market.

Cameron Reynolds: Thank you, Andy, and good morning, everyone. 2025 is a pivotal year for VolitionRx Limited as we focus on commercializing our groundbreaking Nu.Q® platform in the human diagnostics market. As reported previously, we are in confidential discussions with over 10 companies, and I am 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.

Speaker #6: 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.

Speaker #6: 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.

Speaker #6: 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.

Cameron Reynolds: Our goal is to secure multiple licensing agreements in the human diagnostics 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 billion annually, offering substantial revenue opportunities for VolitionRx Limited and our future partners. As a reminder, all the pillars are founded on materially the same nucleosome-based diagnostics technology, which is effective in both cancer and sepsis for both human and animal health uses. VolitionRx Limited is a company powered by Nu.Q® and focused on one theme: measuring chromatin fragments in circulation.

Speaker #6: With diverse deal structures, all with ongoing revenue and some including large milestone payments, our strong clinical evidence supports the broad applicability of our NuQ technology in critical areas such as cancer and sepsis.

Speaker #6: Including as a biomarker of interest to epigenetic drug development, and 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.

Speaker #6: Offering substantial revenue opportunities for Volition and our future partners. As a reminder, all the pillars are founded on materially the same nutraceutical technology, which is effective in both cancer and sepsis for both human and animal health uses.

Speaker #6: Volition is a company powered by NuQ and focused on one thing: measuring chromatin fragments in circulation. This one thing is the basis of all our pillars.

Cameron Reynolds: This one theme 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 XACT FreeNome deal. We are making significant strides in the commercialization of our Nu.Q® Cancer diagnostic pillar. From a licensing perspective, I am 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-PCR™ 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.

Speaker #6: 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.

Speaker #6: 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.

Speaker #6: 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 NuQ and capture-seq technologies.

Speaker #6: 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.

Speaker #6: And I'm delighted that the National Taiwan University Hospital (NTU) team will present intram analysis at the European Society of Medical Oncology Congress in October.

Cameron Reynolds: I am delighted that the National Taiwan University Hospital (NTU) team will present interim analysis at the European Society for 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. 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. We may seek a combination of LDT and regulated products in different markets. As Dr. Andrew Retter 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.

Speaker #6: Positive findings would position our NuQ test for inclusion in the national lung cancer screening programs, representing a potential market exceeding $1 billion annually across Taiwan, the U.S., the U.K., and France alone.

Speaker #6: And this could be implemented relatively quickly in several countries, where NuQ cancer could be made available as a lab development test (LDT), with no need for further regulatory studies. However, we may seek a combination of LDT and regulated products in different markets.

Speaker #6: As Andy discussed, we're also making strong progress with other potential use cases for NuQ Lung Cancer. In particular, as an aid to personalized care by way of treatment selection, and in detecting minimal residual disease.

Speaker #6: We are also making significant headway in the commercialization of NuQ Nets. The first prong of our NuQ Nets commercial strategy is to leverage our granted CE-marked product approved in the EU for any mitosis-related diseases.

Cameron Reynolds: The first prong of our Nu.Q® NETs commercial strategy is to leverage our granted CE-marked product, approved in Europe for any mitosis-related clinical applications. Just as a reminder, VolitionRx Limited’s chemiluminescent immunoassay, a 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 Revity. I would 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.

Speaker #6: Just as a reminder, Volition's chemiluminescent immunoassay (CLIA) version of the CE-marked NuQ test for NETs is run on the IDS-I10 automated analyzer platform from IDS, a subsidiary of Reviti.

Speaker #6: I would 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.

Speaker #6: In a very significant commercial milestone, we recorded our first revenue from sales of our CE-marked NuQ Nets automated product in Europe in Q1 of this year, and sales have continued in the second quarter.

Speaker #6: 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 Nets applications.

Cameron Reynolds: 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 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 product with a view to using it clinically in a diverse range of NET-related uses. We are 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 VolitionRx Limited.

Speaker #6: 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.

Speaker #6: In short, a number of hospital groups in several countries are buying our CE-marked product with a view to using it clinically in the diverse range of NETs-related uses.

Speaker #6: We absolutely delight in the level and breadth of interest that we have seen in the past few quarters, and we continue to receive more inbound inquiries.

Speaker #6: This is a great outcome for Volition. Customers buy kits, generating not only revenue but also clinical data for a very wide range of mitosis use cases in humans.

Cameron Reynolds: Customers buy kits, generating not only revenue but also clinical data for a very wide range of mitosis-related clinical applications in humans. The CE-marked sales are one of the two-pronged approach of VolitionRx Limited'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 Europe and then expand to use worldwide through the expected global out-licensing in mitosis, 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 assay onto their platforms. As Dr. Andrew Retter outlined, our extensive clinical evidence supports the use of our Nu.Q® NETs technology in a critical area, sepsis. Our negotiations and potential licensing agreements reach far beyond sepsis to other NET-related conditions.

Speaker #6: The CE-marked sales are one of the two-pronged approaches of Volition's NuQ 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 mitosis.

Speaker #6: The other prong of our strategy, licensing discussions are progressing well, with several potential licensing companies that have already successfully completed the tech transfer of our assay onto their platforms.

Speaker #6: As Andy outlined, our extensive clinical evidence supports the use of our NuQ Nets technology in a critical area: sepsis. However, our negotiations and potential licensing agreements reach far beyond sepsis to other Nets-related conditions.

Speaker #6: 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.

Cameron Reynolds: 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 VolitionRx Limited 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 mitosis plays a role is extremely broad, equating to a mix of potential market sizes from small to very large. There are clearly wide, unmet clinical needs driving these evaluations. NETs are a key part of a broad range of clinical conditions and are aimed to become the NET company worldwide by partnering with the very best companies, hospital networks, and governments.

Speaker #6: We believe the total addressable market of our NuQ Nets assay could be in excess of $10 billion annually, as the use cases expand far beyond sepsis.

Speaker #6: The range of potential clinical use cases where mitosis plays a role is extremely broad, equating to a mix of potential market sizes, from small to very large.

Speaker #6: 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.

Speaker #6: 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.

Cameron Reynolds: On a personal note, in the near future, I firmly believe the 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 our 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.

Speaker #6: 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 our time in the not-too-distant future when the level of NETs in your system is measured as a standard health check.

Speaker #6: The level of interest in using our NuQ 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.

Speaker #6: We are at different stages of the out-licensing process in humans and negotiations with a range of companies, and I'm very excited about the progress.

Speaker #6: We look forward to announcing our first deal soon. Next up, NuQ Vet. Expanding the global reach of our NuQ Vet cancer test remains a key priority, enabling vets worldwide to improve canine cancer screening and outcomes.

Cameron Reynolds: 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 & Diagnostics Group, Fujifilm Vet Systems, and IDEXX, are instrumental in achieving this. To further accelerate revenue growth and ensure consistent delivery, we are focused on central lab automation. In March, Fujifilm Vet Systems extended their contract with us to validate and then implement a centralized automated platform for the Nu.Q® Vet Cancer Test using 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.

Speaker #6: Our supply agreements with leading industry players, including Antec, part of the Mars Science and Diagnostics Group, Fuji Film Vet Systems, and IDEX, are instrumental in achieving this.

Speaker #6: To further accelerate revenue growth and ensure consistent delivery, we are focused on central lab automation. In March, Fuji Film Vet Systems extended their contract with us to validate and then implement a centralized automated platform for the NuQ Vet cancer test using the IDS-I10.

Speaker #6: I am delighted to report that the Fuji team has made great progress this second quarter in validating the test in-house and is on track to launch the automated platform in the third quarter.

Speaker #6: 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.

Cameron Reynolds: 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 would result from having our tests in annual pet wellness panels. Importantly, this automated platform is the same technology utilized for our human diagnostic products, Nu.Q® Cancer, Nu.Q® NETs, and Nu.Q® Discover, highlighting the inherent synergy and efficiency of our core Nu.Q® platform 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.

Speaker #6: And this has become a particular area of focus for us. We aim to get a large customer's automation so that they can easily and effectively handle the much larger numbers of tests that would result from having our tests in annual pet wellness panels.

Speaker #6: Importantly, this automated platform is the same technology utilized for our human diagnostic products: NuQ Cancer, NuQ Nets, and NuQ Discover, highlighting the inherent synergy and efficiency of our core NuQ technology.

Speaker #6: Our fourth and final pillar, NuQ Discover. Our NuQ 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.

Speaker #6: NuQ 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.

Cameron Reynolds: Nu.Q® Discover is built on proprietary nucleosome quantification technology. It is a valuable research tool for R&D professionals working within the field of pharmacoepigenetics, studying the epigenetic basis for variation in response to drugs. The Nu.Q® Discover pillar spans activities as diverse as supplying research use-only kits, either directly or via our U.S. distributor Diapharma, to providing services such as sample processing on-site in Belgium 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-party multinational clinical trials, with multiple global clients placing repeat orders.

Speaker #6: The NuQ Discover pillar spans activities as diverse as supplying research use-only kits either directly or via our U.S. distributor Diapharma, to providing services such as sample processing on-site in Belgium or California.

Speaker #6: 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.

Speaker #6: NuQ 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 NuQ assays as exploratory biomarkers in third-party multinational clinical trials, with multiple global clients placing repeat orders.

Speaker #6: The largest of these projects has projected revenue in the hundreds of thousands of dollars for an ongoing longitudinal Phase 1, 2b study, targeting completion next year.

Cameron Reynolds: The largest of these projects has projected revenue in hundreds of thousands of dollars for ongoing longitudinal phase 1-2B study targeting completion next year. We are 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, 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.

Speaker #6: We're delighted to support the pharmaceutical company's clinical efforts in developing new drugs for the treatment of large unmet clinical needs. Pharma companies are using NuQ assays as exploratory biomarkers today.

Speaker #6: 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 NuQ platform's versatility across biological samples and disease models but also the issuance of three application notes.

Speaker #6: Interestingly, we're also actively exploring co-marketing partnerships to meet the demand for our NuQ Discover platform that we are seeing worldwide, and hope to be able to sign such a deal with a large industry player in the coming quarter.

Cameron Reynolds: Interestingly, we are 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 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 are 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.

Speaker #6: Our robust pipeline and ongoing service expansion suggest continuing strong NuQ 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.

Speaker #6: There is strong and broad interest in potential out-licensing and/or supply agreements for both NuQ Nets and our oncology portfolio. A range of commercial discussions is progressing well with large companies.

Speaker #6: 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 deals in the human space.

Speaker #6: 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.

Cameron Reynolds: 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 pharma 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.

Speaker #6: 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 pharma EPI drug development.

Speaker #6: We now have evidence to support the use of our NuQ platform across a range of clinical applications with high unmet needs. It is low-cost, robust, and reproducible.

Speaker #6: 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.

Cameron Reynolds: 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 will now take your questions. Operator?

Speaker #6: 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.

Speaker #6: Completing commercial deals for the human indications is the final part of this long journey to complete our mission, and we remain focused on achieving that objective.

Speaker #6: Thank you for joining the call today. We very much appreciate it. And we'll now take your questions. Operator?

Speaker #7: Thank you. As a reminder, if you'd like to join the question queue, please press star one on your telephone keypad. Our first question comes from the line of Justin Walsh with Jones Trading.

Speaker 8: Thank you. As a reminder, if you would like to join the question queue, please press star one on your telephone keypad. Our first question comes from the line of Justin Walsh with Jones Trading. Please proceed with your question.

Speaker #7: Please proceed with your question.

Speaker #8: Hi, thanks for taking the question. Can you comment on which uses of the NuQ platform have been attracting the most attention from potential partners in the human health space?

Justin Walsh: Hi, thanks for taking the question. Can you comment on which uses of the Nu.Q® platform have been attracting the most attention from potential partners in the human diagnostics space?

Speaker #6: Yeah, good question. Justin, actually, I'd have to say pretty much every area we've got. It's been 15 years now since we dreamed big that we could get a platform that is very useful in a very wide range of areas.

Cameron Reynolds: Yeah, good question, Justin. Actually, I would have to say pretty much every area we have got. It has 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 have absolutely cracked it. I mean, if you go through all of them, the Nu.Q® Discover side, we have got over 20 clients now, including the world's biggest companies, so a lot of excitement there. In mitosis-related clinical applications, 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 Nu.Q® NETs space.

Speaker #6: And I think we've absolutely cracked it. I mean, if you go through all of them on the Discover side, we've got over 20 clients now, including the world's biggest companies.

Speaker #6: So, a lot of excitement there. In mitosis, as we talked about, the biggest diagnostic companies and also the large autoimmune and coagulation companies, three of those have been now working on their platforms.

Speaker #6: So a lot of interest in the Nets space. And also, our CE marked kits has now, now been used by, 11 different hospital networks in five different countries.

Cameron Reynolds: Also, our CE-marked kits are now being used by 11 different hospital networks in five different countries for 21 different use cases. You would have to think that has actually taken us by surprise how broad and quickly that has taken off with our sales partners there at IDS Revity. Then, of course, the Nu.Q® Cancer space has actually, in this last quarter, really come roaring back in a whole lot of areas. Obviously, there are all the lung uses. We expect all that data soon, so very big interest from the lung screening programs. Also, we are in discussions with multiple large liquid biopsy companies about out-licensing a basic platform, and so it has been very large interest from that space. So I think you would have to say it is actually not coming from one area, but pretty much everything we do.

Speaker #6: For 21 different use cases, you'd have to think that's actually taking us by surprise how broad and quickly that's taken off. With our sales partners, they're at IDS, Reviti.

Speaker #6: Then, of course, the oncology space has actually, in this last quarter, really, really come roaring back in a whole lot of areas. Obviously, there's all the lung uses.

Speaker #6: We expect all that data soon, so there is very big interest from the lung screening programs. Additionally, we're in discussions with multiple large liquid biopsy companies.

Speaker #6: About licensing our, our basic, our basic platform. And, and so it's been, 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, a really big understanding now that what we do is incredibly important.

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

Speaker #6: 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.

Speaker #6: 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.

Speaker #8: Great, thanks. One, one quick follow-up.

Justin Walsh: Great, thanks. One quick question.

Speaker #6: We 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.

Cameron Reynolds: 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. 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 at the end of September is the end of the quarter.

Speaker #6: So I do expect to close the first, which will be a massive milestone for us. Our this quarter, which of course means this month or next, because it's the end of September, is the end of the quarter.

Speaker #6: Sorry.

Justin Walsh: Great, we're looking forward to that. Maybe a quick follow-up. I am just curious if you are starting to see repeat customers as you are making some of the sales of Nu.Q® NETs in Europe and you are figuring out the best use cases there.

Speaker #8: Great. We're, we're, we're looking forward to that. maybe a quick follow-up. I, I'm just curious if you're starting to see re, repeat customers as you're making some of the sales of, of NuQ Nets in Europe and, and they're figuring out the best use cases there.

Speaker #6: Absolutely. Yeah, 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 test and how well it works.

Cameron Reynolds: Absolutely. Yeah, very much so, actually. Of those 11 networks, multiple of them now have ordered two or three times. They are very much liking the adaptability of the test and how well it works. We are getting a lot of repeat orders in Nu.Q® Discover and Nu.Q® NETs. Actually, a lot of people are also just buying the basic microtiter plates to do their own research as well. If you take over 20 customers in the Nu.Q® Discover group of companies and also the 11 hospital networks on the CE-marked kits, as well as all the ones we are doing on the licensing, a very broad group, and many of them are in multiple, some of them on the third or fourth reorders.

Speaker #6: So we're getting a lot of repeat orders in NuQ Discover and NuQ Nets. And actually, you know, a lot of people are also just buying the basic microtiter plates for their own research as well.

Speaker #6: So, if you take over 20 customers in the NuQ Discover group of companies, and also the 11 hospital networks on the CE-marked kits, as well as all the ones we're doing on the licensing, a very broad group, and, yeah, many of them in multiple; some of them on the third or fourth reorders.

Speaker #8: Thanks for taking the questions.

Justin Walsh: Thanks for taking the questions.

Speaker #6: Thank you, Justin. Take care.

Cameron Reynolds: Thank you, Justin. Take care.

Speaker #7: Thank you. Our next question comes from the line of Jason Culvert with Deep Moral Capital. Please proceed with your question.

Speaker 8: Thank you. Our next question comes from the line of Jason Colbert with Deep Moral Capital. Please proceed with your question.

Speaker #8: Hi, guys. Congratulations on the progress.

Jason Colbert: Hi guys, congratulations on the progress.

Speaker #9: Thank you.

Cameron Reynolds: Thank you.

Speaker #8: 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?

Jason Colbert: 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 Cancer Test?

Speaker #8: For example, in the NuQ Vet.

Speaker #6: Yeah, so ultimately the, you know, our goal is to become revenue neutral, as Terig has pointed out, and that's, and all the things he said on the call.

Cameron Reynolds: Ultimately, our goal is to become revenue neutral, as Terig Hughes just pointed out, and that is in 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 Nu.Q® NETs space, as well as the Nu.Q® Discover space, and the vet space, and the human diagnostics space. We are looking to sign a wide range of deals. In the mitosis-related clinical applications space, for example, there are 21 different use cases now. The deals we expect on the deficit 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.

Speaker #6: So we are expecting each deal is going to be different as in the vet space. in the, in the Nets space as well as the Discover space and the Vet space and the human space.

Speaker #6: We're looking to sign a wide range of deals in the mitosis space. For example, there are 21 different use cases now. The deals we expect on the sepsis side, we do expect very large payments and ongoing revenues.

Speaker #6: Some of the use cases in coagulation and the autoimmune diseases are smaller indications, so we will not be expecting very large checks. However, any one of the deals, if they're spending, you know, millions of dollars to launch a product on our intellectual property, it's a very good thing for us.

Cameron Reynolds: But any one of the deals, if they are spending millions of dollars to launch a product on our intellectual property, it is 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. As we said, we have a lot going through the space. The next big things in the vet space you mentioned specifically, I think we are close, or Fujifilm Vet Systems are close to their independent validation of the centralized lab to get the I10, the same machine we use in the human diagnostics space, working in centralized labs in vet.

Speaker #6: And, and I think it, it helps in 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, keep those negotiations moving.

Speaker #6: And as we said, we have a lot going through the space. The next big things in the vet space you mentioned specifically, I think we are close, or Fuji is close to their independent validation of the centralized lab to get the I10, same machine we use in the human space, working in centralized labs in vet.

Speaker #6: That would be the time when I think it can allow it to be in the wellness panels for dogs. Which would then, I think, potentially move to those large amounts of tests we all want, you know, in the millions of tests, not the 100,000 right now.

Cameron Reynolds: 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 the 100,000 right now. So that is progressing very well. We are also closing in on the.

Speaker #6: So, that's progressing very well. We're also closing in on the...

Speaker #8: Thank you. That's very helpful.

Jason Colbert: Thank you, that is very helpful.

Speaker #6: Thank you.

Cameron Reynolds: Thank you.

Speaker #8: Okay. Congratulations on the progress.

Jason Colbert: Congratulations on the progress.

Speaker #6: Thank you, Jason. Take care.

Cameron Reynolds: Thank you, Jason. Take care.

Speaker #7: Thank you. Our next question comes from the line of Yi Chen with HC Wainwright. Please proceed with your question.

Speaker 8: Thank you. Our next question comes from the line of Yu Chen with HC Wainwright. Please proceed with your question.

Speaker #10: Good morning, Yi.

Cameron Reynolds: Good morning.

Speaker #7: Mr. Chen, it seems you're on mute.

Speaker 8: Mr. Chen, you seem to be on mute.

Speaker #10: 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?

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

Speaker #6: Very good question. So, we haven't given the details on what the first deal is in the part you'll find out when they're released.

Cameron Reynolds: A very good question. We haven't given the details on what the first deal is, but you'll find that out when they're released. Obviously, there's confidentiality until they're finished. 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. Andrew Retter so well pointed out, in many, many different use cases. 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. 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.

Speaker #6: Obviously, there's confidentiality until they're finished. But to give some flavor to them all, all of them depend on the use of our test. Our test is now robust, reproducible, and reliable.

Speaker #6: It's been shown, as Dr. Andrew Retter so well pointed out in many different use cases. 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 and launch the product.

Speaker #6: So if you think of it this way, they're building on our land and then, you know, have to pay us for, for every process.

Speaker #6: We are working on some very large deals. We're also working on some deals in smaller indications, which are still very important—indications where millions of people are afflicted by that particular issue. What particular areas are worldwide?

Cameron Reynolds: 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, in the Nu.Q® Discover space. Those contracts can be quite large, but we don't want to hire a large sales force in the Nu.Q® Discover space, as we have not in the Nu.Q® NETs or the Nu.Q® Cancer space. We're probably closer to be able to outline the terms, for example, with the national screening program in non-small cell lung cancer. We've talked about the potential market being millions of tests per year, just in the countries we're working in now.

Speaker #6: 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 about what they are until they're released, of course.

Speaker #6: 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.

Speaker #6: We're probably closer to being 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.

Speaker #6: 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 whether it's direct sales or through partners.

Cameron Reynolds: We look to be getting up to about $50 per test in those countries, depending on if it's direct sales or through partners. Obviously, those are very large deals and potentially are closer because the final data is now being worked on. 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. Our intellectual property is very strong. I think the use cases are very broad and very valuable. 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. I think as a package, they'll be very attractive to our partners and to our shareholders.

Speaker #6: So obviously, those are very large deals and, potentially, closer because the final data is now being worked on. so as we said, we are expecting, deals in the short term.

Speaker #6: And we'd 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.

Speaker #6: 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 make sense just in the, in the smaller numbers of millions of dollars.

Speaker #6: Potential revenue per year. But I think, as a package, they'll be very attractive to our partners and to our shareholders.

Speaker #10: Thank you. 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?

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

Speaker #6: That's a very good question. So, obviously in the co-marketing and Discover, it would be straight away that would be selling the kits and processes immediately.

Cameron Reynolds: That's a very good question. So, obviously, in the co-marketing 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 D-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 cutoffs for their own use cases. As we said, there are 21 of those we know of now. So, we'd expect that through next year. Ones where they have to adapt 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.

Speaker #6: 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.

Speaker #6: 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 cut-offs for their own, for their own, for their own use cases.

Speaker #6: And as we said, there are 21 of those we know of now, so we'd expect that through next year. For ones where they have to adapt it to their platform, a lot of those have already done that.

Speaker #6: 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.

Cameron Reynolds: A regulatory path for either CE-marked or FDA takes between two to three years, depending on the process. The CE-marked IVDR takes about two years. We'd expect the FDA to take about three years, as from what we understand, it is a 510(k). For the moment, on the IVDR, it's a class B. So, we're looking more two years than sort of three or four or five, but the FDA can take a little longer than that. So, 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. 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.

Speaker #6: The CE mark IVDR takes about two years. We'd expect the FDA to take about three years. As far as we understand, it is a 510(k), and for the moment, on the IVDR, it's a Class B.

Speaker #6: So, we're looking at more like two years than sort of three, four, or five. But the FDA can take a little longer than that. But, the short answer is, for some of them, it's immediate revenue from the process.

Speaker #6: 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, along with all the autoimmune diseases associated with NETs, which are a very large number.

Speaker #6: And coagulation. Also, they're doing a lot of work in organ rejection, burns, trauma—all the different uses. So from today to about three to four years is the different timeline it would take them, Yi.

Cameron Reynolds: 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 some use.

Speaker #10: Thank you, that's very helpful.

Yu Chen: Thank you. That's very helpful.

Speaker #6: Thanks for your time.

Cameron Reynolds: Thanks for your time.

Speaker #7: Thank you. Our next question comes from the line of Bruce Jackson with the Benchmark Company. Please proceed with your question.

Speaker 8: Thank you. Our next question comes from the line of Bruce Jackson with The Benchmark Company. Please proceed with your question.

Speaker #8: Hi, good morning, and 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.

Jason Colbert: Hi, good morning, and thanks for taking my questions. Just two follow-ups on the clinical programs. With the Taiwan screening programs, 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? Do you do that in Taiwan?

Speaker #8: Are they prepared to scale that type of program? And do you have the test on a high-volume analyzer right now to do that in Japan?

Speaker #6: Yeah. Yes. So the trials are currently being done in Taiwan, which are the final validation study. Hopefully, that data continues on with the great results we've got.

Cameron Reynolds: Yes. The trials are currently being done in Taiwan as a final validation study. Hopefully, that data continues on with the great results we have got. They have worked on cross-validation between France and Taiwan, which has also worked well. It is on that machine, which would be the machine they would 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 are reviewing now as to the availability, whether it is worth doing that. I think most likely we would 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.

Speaker #6: and, they've worked on cross-validation between France and Taiwan, which is also worked well. So it is on that machine, which would be the machine they'd launch.

Speaker #6: 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.

Speaker #6: You could also go for the Taiwanese FDA to make it more of a product, which we're reviewing now as to the availability and whether it's worth doing that.

Speaker #6: 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.

Speaker #6: And then more, 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.

Cameron Reynolds: The Taiwanese FDA process would take something around 12 months from what we can tell. Yes, it is currently on the machine. No, we do not need any more tech transfer. Yes, they are interested in launching it in the clear lab. The clear lab running the current process is very closely associated with the national program, so that could be done quite quickly. If it went well, we would expect it could be on the market and generating revenue in the first half of the next year. That is also obviously dependent on the data and the process, but it is something that could happen quite quickly.

Speaker #6: 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.

Speaker #6: So, if it went well, we'd expect it could be on the market and generating revenue in the first half of next year.

Speaker #6: that's also obviously dependent on the data and the, 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 in, or any, any process, anyone running the test in, in Taiwan.

Cameron Reynolds: 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 are working with the national screening program as well. It is currently on the machine again, the Revity machine, so that could be done. They would want to do a validation study similar to what is being done in Taiwan. I think the earliest we would be in any part of the national screening program of France would be the next year, 2027. The next step would be to sign up for a validation study in Taiwan as we have in France as we have in Taiwan.

Speaker #6: On the French side, we're working with the national screening program as well. It's currently on the machine again, the Reviti machine, so that could be done.

Speaker #6: 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, in any part of the national screening program of France would be the next year, 2027.

Speaker #6: But, the next step would be, to sign up for a, a validation study in Taiwan as we have, sorry, in France as we have in Taiwan.

Speaker #6: And we're hoping to have news on that this year, so it starts running by the end of this year. We can do the implementation next year to be part of some regions of the French program by 2027.

Cameron Reynolds: We are 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.

Speaker #10: 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?

Jason Colbert: Okay. 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?

Speaker #6: no, 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.

Cameron Reynolds: It is on the current machine. This is the validation study. It is in the lab that could be done. We are not aware of that currently, and we are in the process. It has been worked on very closely with the people doing the trials in PEST-YU, and obviously, Dr. Quay, our head of ASA, has done a lot of work on this. She was actually there last week and going back again in August with our scientific team. It is 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 get generating us direct sales revenue, potentially of around $50 per test. We are working with them now on that directly to VolitionRx Limited.

Speaker #6: So, it's been worked on very closely with the people doing our trials in PSAU and, obviously, Dr. Kuay. Our head of Asia has done a lot of work on this.

Speaker #6: She was actually there last week and is going back again in August with our scientific team. But it's plausible that if the trial goes well, which is what we expect—you never know—but the data has been very good so far.

Speaker #6: It could be launched in a clear lab setting and generate us direct sales revenue, potentially of around $50 per test, where we're working with them now on that.

Speaker #6: directly to Volition. So it could be something that becomes a big part of our revenue story next year if it continues to go as well as it has.

Cameron Reynolds: 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.

Speaker #10: Okay. And then my second line of questioning is around the lateral flow test for NETs. You did a, I guess it was a proof of concept type of study.

Jason Colbert: Okay. My second line of question is around the lateral flow test for Nu.Q® 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?

Speaker #10: Was that an internally developed platform, or did you work with a partner on that?

Speaker #6: We haven't disclosed who the partner is, but we work with several partners on the lateral flow. It worked very well on venous blood, and we're now working through capillary blood.

Cameron Reynolds: We haven't disclosed who the partner is, but we work with several partners on the lateral flow. It worked very well on venous bloods, and we're now working through capillary blood. We're extremely happy with the way that's gone, and it's also a quantitative test in the very, very good range for mitosis up into very, very high levels. We, as in the vet space, think the centralized labs are probably the biggest market. 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. 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 something as a routine blood test that goes to the central lab and comes back.

Speaker #6: But we're extremely happy with the way that has gone, and it's also a quantitative test in the very, very good range for mitosis, up into very, very high levels.

Speaker #6: So we, as in the vet space, 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 is very, very helpful.

Speaker #6: 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.

Speaker #6: You know, a hospital is much more likely to want just something as a routine blood test that goes to the central lab and comes back.

Speaker #6: But if you want to take-home tests, or in developing countries, or a range of other use cases, we think there could be a very attractive market for the lateral flow as well.

Cameron Reynolds: But if you want a take-home test or in developing countries or a range of other use cases, we think there could be a very attractive market for the lateral flow as well. We are very excited that worked as well as it did. We should have some more news on that later this year. We are working with external partners as in contractors, not people we're directly licensed 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. The cost of goods typically on those tests is in the very small number of dollars, like $1 or $2 to make. Potentially, it's a very lucrative addition to our revenue stream in the coming years.

Speaker #6: So very excited that it worked as well as it did. We should have some more news on that later this year. And we are working with external partners, as in contractors, not people we're directly licensed to.

Speaker #6: We are, we are aimed to keep that, for ourselves and be able to sell that directly ourselves. As we have in the lung program, directly to customers.

Speaker #6: And the cost of goods typically on those tests is in the very small number of dollars, like one or two dollars to make. So potentially, it's a very lucrative addition to our revenue stream.

Speaker #6: in the coming years.

Speaker #10: Okay, great. That's it for me. Thank you.

Jason Colbert: Okay, great. That is it for me. Thank you.

Speaker #6: Thanks, Bruce. Take care.

Cameron Reynolds: Thanks, Bruce. Take care.

Speaker #7: 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.

Speaker 8: Thank you. Ladies and gentlemen, that concludes our question and answer session. I will turn the floor back to Mr. Reynolds for any final comments.

Speaker #6: 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.

Cameron Reynolds: Thank you very much for your time. It has 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 Nu.Q® Cancer and Nu.Q® Discover as well as the Nu.Q® NETs platform. It has been 15 years now. We really dreamt big to get a platform that is robust, reliable, and useful in a very wide range of areas where measuring chromatin fragments can be useful. I have to say, it has happened beyond what we could have dreamed of early on with the addition of mitosis-related clinical applications to all the oncology markers and also moving into the animal space.

Speaker #6: It's been 15 years now. We really dreamed big to get a platform that's robust, reliable, and useful in a very wide range of areas.

Speaker #6: We're measuring chromatin fragments, which can be useful. I have to say it's happened beyond what we could have dreamed of early on with the addition of mitosis to all the oncology markers.

Speaker #6: 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.

Cameron Reynolds: So keep track of all the things we are doing. There is 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 are doing. Thank you very much for your time, and I look forward to updating you all as this all comes through. Thank you.

Speaker #6: 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 addressing.

Speaker #6: Thank you very much for your time. I look forward to updating you all as this all comes through. Thank you.

Speaker 8: Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.