Q4 2025 VolitionRx Ltd Earnings Call

April 1, 2026

Speaker #1: Good morning , ladies and gentlemen , and thank you for standing by . Welcome to VOLITIONRX LTD Limited . Full Fiscal Year 2025 Earnings Call .

Operator: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Full Fiscal Year 2025 Earnings Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be opened for questions. 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.

Speaker #1: During today's presentation , all parties will be in a listen only mode . Following the presentation , the conference call will be open for questions .

Speaker #1: If you have a question, please press the star key followed by the number one on your touchtone phone. If you would like to withdraw your question, please press the star key followed by the number two.

Speaker #1: If you're using speaker equipment , please lift the handset before making your selections . This conference call is being recorded today , April 1st , 2026 .

Operator: If you're using speaker equipment, please lift the handset before making your selections. This conference call is being recorded today, 1 April 2026. I would now like to turn the call over to Louise Day, Group Chief Marketing and Communications Officer. Please go ahead.

Speaker #1: I would now like to turn the call over to Luis Bachelor, Group Chief Marketing and Communications Officer. Please go ahead.

Speaker #2: 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, 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.

Speaker #2: 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 .

Louise Batchelor: 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 #2: 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.

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.

Speaker #2: We do not undertake an obligation to update any forward-looking statements made during the course of this call. Cameron Reynolds, Group Chief Executive Officer, will open the call, providing a summary of key achievements in 2025.

Louise Batchelor: Cameron Reynolds, Group Chief Executive Officer, will open the call, providing a summary of key achievements in 2025. Terry Hughes, Chief Financial Officer, will then provide a financial report before handing over to Drs. Retter and Micallef, who will present research highlights from across our product pillars. Cameron will close with a discussion of upcoming milestones. We will then open the conference call to a question and answer session. With that, I'll turn the call over to Cameron.

Speaker #2: Terig Hughes, Chief Financial Officer, will then provide a financial report before handing over to Doctors Rita and McAuliffe, who will present research highlights from across our product pillars. Cameron will close with a discussion of upcoming milestones.

Speaker #2: We will then open the conference call to a question-and-answer session. And with that, I'll turn the call over to Cameron.

Speaker #3: Thanks , Lou , and thank you , everyone for joining Volition's full fiscal 2025 earnings call today . As always , we very much appreciate your time .

Cameron Reynolds: Thanks, Lu, and thank you everyone for joining Volition's full fiscal 2025 earnings call today. As always, we very much appreciate your time, given the busy earnings call season. Before diving into detail, I would like to take a moment to reflect on our founding mission. We set off over 15 years ago to help save lives and improve outcomes for millions of patients worldwide, and I could not be prouder of the progress we have been making towards that goal.

Speaker #3: Given the busy earnings call season, before diving into detail, I would like to take a moment to reflect on our founding mission.

Speaker #3: We set off over 15 years ago to help save lives and improve outcomes for millions of patients worldwide, and I could not be prouder of the progress we have been making towards that goal.

Speaker #3: In the fourth quarter of 2025, we not only received our first order from the NUC cancer assays for clinical certification ahead of routine clinical use in lung cancer, but we also announced the inclusion of our new Q assay in a real-world interventional evaluation of early detection of sepsis in a government-backed, approximately $7.3 million program.

Cameron Reynolds: In Q4 of 2025, we not only received our first order from the Nu.Q Cancer assays for clinical certification ahead of routine clinical use in lung cancer, but we also announced the inclusion of our Nu.Q NETs assay in real-world interventional evaluation of early detection of sepsis in a government-backed approximately $7.3 million program in France.

Speaker #3: Program in France. Our tests are about to be used in both these devastating diseases to help save lives in the real world.

Cameron Reynolds: Our tests are about to be used in both these devastating diseases to help save lives in the real-world hospital settings. An extremely proud moment for our entire team. Cancer and sepsis are leading causes of death, accounting for approximately a third of deaths worldwide. With the first clinical use now imminent, we're about to be part of the solution through simple, easy-to-use, low-cost tests.

Speaker #3: Hospital settings and extremely proud moment for our entire team Cancer and sepsis are leading causes of death , accounting for approximately a third of deaths worldwide , with the first clinical use now imminent We're about to be part of the solution through simple , easy to use , low cost tests .

Speaker #3: I believe we will look back on 2025, this first quarter of '26, and even in time for the next few quarters, as transformational for the company in 2025.

Cameron Reynolds: I believe we will look back on 2025, this Q1 of 2026, and even into the next few quarters, as transformational for the company. In 2025, efforts for VolitionRx focused on commercializing our groundbreaking Nu.Q platform in the human diagnostic market. We're excited to start the implementation of our human licensing strategy with the signing of not one, but two agreements. The first with Antiphospholipid Syndrome, APS, with warfarin, and a co-marketing services agreement with Hologic.

Speaker #3: Efforts for Volition focused on commercializing our groundbreaking new platform in the human diagnostic market. We're excited to start the implementation of our human licensing strategy with the signing of not one, but two agreements.

Speaker #3: The first with Antiphospholipid syndrome, APS, with Werfen, and a co-marketing services agreement with Hologic. Both are multi-billion dollar companies and worldwide leaders in their specialized field, and we are delighted to be working with them.

Cameron Reynolds: Both are multi-billion dollar companies and worldwide leaders in their specialized field, and we are delighted to be working with them. We have further strengthened our intellectual property portfolio and are continuing our licensing discussions with around 10 of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of negotiation process across all our different pillars, and we anticipate announcing additional agreements throughout 2026.

Speaker #3: We have further strengthened our intellectual property portfolio and are continuing our licensing discussions with around ten of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the negotiation process across all our different pillars, and we anticipate announcing additional agreements throughout 2026.

Speaker #3: Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vet market, and we anticipate diverse deal structures with potential for upfront and milestone payments and future recurring revenue. We have developed a truly remarkable, versatile platform and are working with governments and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide.

Cameron Reynolds: Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vet market. We anticipate diverse deal structures with potential for upfront and milestone payments and future recurring revenue. We have developed a truly remarkable, versatile platform and are working with governments and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide as quickly as possible.

Speaker #3: As quickly as possible Beyond licensing , we also achieved several significant commercial milestones in 2025 . In the first quarter . We recorded our first revenue from sales of our CE marked new Kusnetz automated assay , a regulated , clinically approved product Nets , or more specifically , Netosis , goes far beyond just sepsis and is implicated in a very wide range of diseases .

Cameron Reynolds: Beyond licensing, we also achieved several significant commercial milestones in 2025. In Q1, we recorded our first revenue from sales of our CE-marked Nu.Q NETs automated assay, a regulated, clinically approved product. NETs, or more specifically, NETosis, goes far beyond just sepsis and is implicated in a very wide range of diseases. Currently, 12 hospital networks across a number of countries are evaluating our Nu.Q NETs assay across 15 different clinical use cases and indications.

Speaker #3: Currently, 12 hospital networks across a number of countries are evaluating our new Q nets assay across 15 different clinical use cases and indications.

Speaker #3: We believe nets testing will become a key part of routine blood testing . In February of 2025 . We announced our first commercial sale of Volition's proprietary high throughput nets method that measures neutrophil extracellular traps , nets activation and inhibition in whole blood in real time , helping companies develop new therapeutics to combat sepsis and other nets related diseases In March , we signed an agreement with a leading pharmaceutical company to utilize Volition's new Q discover biomarkers in a longitudinal phase one Too-b study .

Cameron Reynolds: We believe NETs testing will become a key part of routine blood testing. In February 2025, we announced our first commercial sale of Volition's proprietary high-throughput NETs method that measures neutrophil extracellular traps, NETs, activation and inhibition in whole blood in real time, helping companies develop new therapeutics to combat sepsis and other NETs-related disease.

Cameron Reynolds: In March, we signed an agreement with a leading pharmaceutical company to utilize Volition's Nu.Q Discover biomarkers in a longitudinal phase 1 to 2B study, the first human clinical study with a pharmaceutical company sponsor that our test supports. Through our Nu.Q Discover pillar, we are now serving close to 100 clients worldwide, including many top pharma and diagnostic companies, accelerating disease research and drug development across multiple therapeutic areas.

Speaker #3: The first human clinical study with a pharmaceutical company sponsor that our test supports, through our new COO, Discover Pillar. We are now serving close to 100 clients worldwide, including many top pharma and diagnostic companies.

Speaker #3: Accelerating disease research and drug development across multiple therapeutic areas. Some of these pharmaceutical companies are progressing to late-stage clinical trials using our assays as pharmacodynamic biomarkers.

Cameron Reynolds: Some of these pharmaceutical companies are progressing to late-stage clinical trials using our assays as pharmacodynamic biomarkers. We estimate the total addressable market for relevant companion diagnostics to be a little under $1 billion. In 2025, we delivered substantial revenue growth for Nu.Q Discover, which Terig will detail, and we anticipate a similar trajectory in 2026. The Nu.Q Vet Cancer test is the number one canine cancer screening blood test in the world, now available in over 20 countries.

Speaker #3: We estimate the total addressable market for relevant companion diagnostics to be a little under $1 billion in 2025. We delivered substantial revenue growth for new Q Discover, which we will detail, and we anticipate a similar trajectory in 2026.

Speaker #3: The new Cuvette cancer test is the number one canine cancer screening blood test in the world, now available in over 20 countries. To further accelerate revenue growth and ensure consistent delivery,

Cameron Reynolds: To further accelerate revenue growth and ensure consistent delivery, we focused on central lab automation. In March 2025, Fujifilm Vet Systems extended their contract to implement a centralized automated platform for the Nu.Q Vet Cancer test using IDS-i10 made by Revvity.

Speaker #3: We focused on central lab automation in March of 2025. Fujifilm Vet Systems extended their contract to implement a centralized, automated platform for the new Cuvette cancer test using IDs i10 made by Revati.

Speaker #3: Subsequent to year-end in March of this year, we announced the completion of all validation and verification of the chemical luminescent immunoassay.

Cameron Reynolds: Subsequent to year-end, in March of this year, we announced the completion of all validation and verification of the chemiluminescent immunoassay CLIA version of the Nu.Q Vet Cancer test with Fujifilm Vet Systems in Japan, allowing use of full automation rather than manual plates in central labs. This is a world first and will significantly enhance turnaround times and throughput to meet increasing demand. We believe that central lab automation is crucial for scaling of our vet business and integrating our test into routine pet wellness panels.

Speaker #3: Clear version of the new cuvette cancer test, with Fuji Vet Systems in Japan, allowing use of full automation rather than manual plates in central labs. This is a world first and will significantly enhance turnaround times and throughput to meet increasing demand.

Speaker #3: We believe that central lab automation is crucial for the scaling of our vet business and integrating our test into routine pet wellness panels. Importantly, this automation platform is the same technology utilized for our human diagnostic products.

Cameron Reynolds: Importantly, this automation 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. From a product expansion perspective, we made great progress with our research in the use of Nu.Q NETs in cats. In May 2025, we announced the publication of our first clinical paper reporting the detection of nucleosomes in cats.

Speaker #3: New Q Cancer, New Q Nets, and new discoveries highlighting the inherent synergy and efficiency of our core New Q platform. From a product expansion perspective, we made great progress with our research in the use of New Q Nets in cats.

Speaker #3: In May of 2025 , we announced the publication of our first clinical paper reporting the detection of nucleosomes in cats and subsequent to year end in early January of this year , we reported results from a clinical study demonstrating the high accuracy of its new cuvette feline assay in detection of lymphoma in cats , the most common cancer in the species , at 100% specificity , meaning no false positives The assay detected over 80% of feline lymphomas .

Cameron Reynolds: Subsequent to year-end, in early January of this year, we reported results from a clinical study demonstrating the high accuracy of its Nu.Q Vet Feline assay in detection of lymphoma in cats, the most common cancer in the species. At 100% specificity, meaning no false positives, the assay detected over 80% of feline lymphomas.

Speaker #3: This breakthrough marks the development of what we expect to be the world's first simple , affordable , blood based liquid biopsy test for feline cancer , a significant unmet need in veterinary medicine This opens up the potential for cancer screening , screening , and monitoring in cats .

Cameron Reynolds: This breakthrough marks the development of what we expect to be the world's first simple, affordable, blood-based liquid biopsy test for feline cancer, a significant unmet need in veterinary medicine. This opens up the potential for cancer screening and monitoring in cats. There are more than 60 million cats in the US alone, 25% of which are senior cats and therefore suitable for an annual check. This represents a tremendous commercial opportunity for Volition.

Speaker #3: There are more than 60 million cats in the US alone, 25% of which are senior cats and therefore suitable for an annual check.

Speaker #3: This represents a tremendous commercial opportunity for volition . The publication of this study , in a peer reviewed journal is expected subsequently to unlock a 5 million milestone contract payment , and we will also generate ongoing revenue in this large and growing market where our technology meets an unmet need .

Cameron Reynolds: The publication of this study in a peer-reviewed journal is expected subsequently to unlock a $5 million milestone contract payment. We will also generate ongoing revenue in this large and growing market where our technology meets an unmet need. Incredibly quick progress from a product development perspective and great to add a third species for Nu.Q. I will return at the end of this call to discuss some additional recent achievements and upcoming milestones. Now we'll pass over to Terig for a finance report.

Speaker #3: Incredibly quick progress from a product development perspective, and great to add a third species for new Q. I will return at the end of this call to discuss some additional recent achievements and upcoming milestones.

Speaker #3: But now we'll pass over to Terig Hughes for a finance report . Thanks very much , Cameron , and hello everyone . I am now delighted to provide a full fiscal year financial report for the year to December 31st , 2025 .

Terig Hughes: Thanks very much, Cameron, and hello, everyone. I'm now delighted to provide a full fiscal year financial report for the year to December 31, 2025. From a revenue perspective, we finished the year strongly with year-on-year growth for Q4 of 133%. For the full year 2025, we recorded $1.7 million in revenue, a growth of 40% over the full year 2024. I'm delighted to report we received our first revenue from the CE mark Nu.Q NETs product in Europe during 2025.

Speaker #3: From a revenue perspective , we finished the year strongly with year on year growth for Q4 of 133% . For the full year 2025 , we recorded $1.7 million in revenue , a growth of 40% over the full year 2024 .

Speaker #3: And I'm delighted to report we received our first revenue from the CE-marked new QNET product in Europe during 2025. We also received our first order for new Q Cancer from Leon for the certification of our cancer test in their hospital network, more of which in Romandie.

Terig Hughes: We also received our first order for Nu.Q Cancer from Lyon for the certification of our cancer test in their hospital network, more of which from Andy later in the call. As we have stated previously, at this early stage of commercialization, revenues remain fairly lumpy and difficult to predict from one quarter to the next.

Speaker #3: Later in the call, as we have stated previously, at this early stage of commercialization, revenues remain fairly lumpy and difficult to predict.

Speaker #3: From one quarter to the next . So while I remain confident of continuing to see solid growth year over year , we will not be providing revenue guidance for 2026 at this point in time from an expenditure perspective , we significantly reduced operating expenses which were $4.8 million lower , a reduction of 17% compared to the full year 2024 .

Terig Hughes: While I remain confident of continuing to see solid growth year over year, we will not be providing revenue guidance for 2026 at this point in time. From an expenditure perspective, we significantly reduced operating expenses, which were $4.8 million lower, a reduction of 17% compared to the full year 2024. Indeed, looking at the trend over the last two years, we are now operating at significantly lower levels of expenditure. Furthermore, we will continue to take measures to reduce costs further over the coming year.

Speaker #3: And indeed , looking at the trend over the last two years , we are now operating at significantly lower levels of expenditure . Furthermore , we will continue to take measures to reduce costs further over the coming year .

Terig Hughes: Net cash used in operating activities was $19.7 million in 2025. This compared with $25.9 million in 2024. Cash and cash equivalents at the end of the year totaled approximately $1.1 million.

Speaker #3: Net cash used in operating activities was $19.7 million in 2025. This compared with $25.9 million in 2024. Cash and cash equivalents at the end of the year totaled approximately $1.1 million.

Terig Hughes: However, subsequent to year-end and through 25 March, we received approximately $5.4 million in net proceeds from our at-the-market or ATM facility and $1.9 million in net proceeds from issuance of a convertible note to Lind Global Asset Management XII LLC. We continue to receive significant support from agencies of the Walloon region in Belgium, and subsequent to year-end, we announced non-dilutive funding of approximately $2.3 million.

Speaker #3: However , subsequent to year end and through March 25th , we received approximately $5.4 million in net proceeds from our at the market or ATM facility and $1.9 million in net proceeds from issuance of a convertible .

Speaker #3: Note to Lind Global Asset Management, LLC: We continue to receive significant support from agencies of the Walloon region in Belgium, and subsequent to year end, we announced non-dilutive funding of approximately $2.3 million.

Terig Hughes: This takes the non-dilutive funding support from all sources from inception to date to over $25 million. To summarize the finance report, key indicators are trending positively. Revenue was up 40% year on year. Operating expenses were down 17% on a full year 2025 basis. Net cash used in operating activities was down 24% year on year. We continue to work on reducing our underlying operating expenses.

Speaker #3: This takes the non-dilutive funding support from all sources from inception to date to over $25 million. So, to summarize the finance report: key indicators are trending positively.

Speaker #3: Revenue was up 40% year on year . Operating expenses were down 17% on a full year 2025 basis . Net cash used in operating activities was down 24% year on year .

Speaker #3: We continue to work on reducing our underlying operating expenses. We expect to secure a $5 million milestone payment from our existing agreement in the vet space.

Terig Hughes: We expect to secure a $5 million milestone payment from our existing agreement in the vet space. Last but not least, licensing discussions are progressing well, and I look forward to providing updates as they progress. Throughout 2025, and indeed subsequent to year-end, we have made significant scientific and clinical progress. With that, I will hand over to Andy and Jake.

Speaker #3: And last but not least, licensing discussions are progressing well, and I look forward to providing updates as they progress throughout 2025 and, indeed, subsequent to year-end.

Speaker #3: We have made significant scientific and clinical progress. And so with that, I will hand over to Andy and Jake. Thank you.

Andrew Retter: Thank you, Terig, and hello everyone. I appreciate there is an incredible volume of information shared on these calls, so I will try and limit my comments to what I believe are recent important clinical achievements. I'll start with Nu.Q NETs. NETosis is an area of increasing scientific interest with a significant number of research articles published in recent years. In February, a review article entitled The NET Effect: Neutrophil Extracellular Traps, a potential key component of the dysregulated host immune response, was written by myself alongside two key opinion leaders in the sepsis arena, Professor Djillali Annane, and Professor Mervyn Singer. This paper has already been accessed more than 11,000 times and cited in almost 60 peer-reviewed publications. From a clinical utility perspective, we have published two key papers. The first was with the team from Amsterdam UMC, looking at more than 1,700 critically ill patients.

Andy Retter: Thank you, Terig, and hello everyone. I appreciate there is an incredible volume of information shared on these calls, so I will try and limit my comments to what I believe are recent important clinical achievements. I'll start with Nu.Q NETs. NETosis is an area of increasing scientific interest with a significant number of research articles published in recent years.

Speaker #3: Terig, and hello everyone. I appreciate there is an incredible volume of information shared on these calls, so I will try and limit my comments to what I believe are recent, important clinical achievements.

Speaker #3: I'll start with new keynotes. Mitosis is an area of increasing scientific interest, with a significant number of research articles published in recent years.

Andy Retter: In February, a review article entitled The NET Effect: Neutrophil Extracellular Traps, a potential key component of the dysregulated host immune response, was written by myself alongside two key opinion leaders in the sepsis arena, Professor Djillali Annane, and Professor Mervyn Singer.

Speaker #3: In February, a review article entitled 'The NET Effect: Neutrophil Traps, a Potential Key Component of the Dysregulated Host Immune Response,' was written by myself alongside two key opinion leaders in sepsis, Arena.

Speaker #3: Professor Hannan and Professor Mervyn Singer. This paper has already been accessed more than 11,000 times and cited in almost 60 peer-reviewed publications from a clinical utility perspective.

Andy Retter: This paper has already been accessed more than 11,000 times and cited in almost 60 peer-reviewed publications. From a clinical utility perspective, we have published two key papers. The first was with the team from Amsterdam UMC, looking at more than 1,700 critically ill patients.

Speaker #3: We have published two key papers. The first was with the team from UMC Amsterdam, looking at more than 1,700 critically ill patients.

Andrew Retter: That paper is available free to download from Critical Care. The second paper, available on medRxiv, written with our colleagues in Jena, is another independent study looking at 971 patients with sepsis. Together, the data from these studies show that Nu.Q H3.1 accurately distinguishes sepsis from non-infectious systemic inflammation. It is strongly correlated with disease severity and provides excellent prognostic information for outcomes such as organ failure, specifically renal failure, and mortality. The prognostic power of H3.1 measured at ICU admission significantly exceeded existing severity scores such as APACHE II and the SOFA score.

Andy Retter: That paper is available free to download from Critical Care. The second paper, available on medRxiv, written with our colleagues in Jena, is another independent study looking at 971 patients with sepsis. Together, the data from these studies show that Nu.Q H3.1 accurately distinguishes sepsis from non-infectious systemic inflammation.

Speaker #3: That paper is available free to download from Critical Care. The second paper, available on medRxiv, written with our colleagues in Vienna, is another independent study looking at 971 patients with sepsis.

Speaker #3: Together , the data from these studies show that new QH3 point one accurately distinguishes sepsis from non-infectious systemic inflammation . It is strongly correlated with disease severity and provides excellent prognostic information for outcomes such as organ failure .

Andy Retter: It is strongly correlated with disease severity and provides excellent prognostic information for outcomes such as organ failure, specifically renal failure, and mortality. The prognostic power of H3.1 measured at ICU admission significantly exceeded existing severity scores such as APACHE II and the SOFA score.

Speaker #3: Specifically , renal failure , and mortality . The prognostic power of H 3.1 , measured at ICU admission , significantly exceeded existing severity scores , such as Apache two and the Sofa score .

Andrew Retter: As a result of this convincing evidence, in December, we were delighted to announce the inclusion of our Nu.Q NETs test as the sole biomarker in the DETECSEPS study, a real-world evaluation using H3.1 in combination with the National Early Warning Score to promote the early detection of sepsis and try and promote the flow of patients through emergency rooms. This is a problem every healthcare system in the world faces. Not only is DETECSEPS led by prominent clinicians, it is also backed with financing from the French government. DETECSEPS aligns with Volition's core purpose of operationalizing our understanding of epigenetics, and in particular of H3.1 in clinical practice, to help identify and monitor the severity of disease.

Andy Retter: As a result of this convincing evidence, in December, we were delighted to announce the inclusion of our Nu.Q NETs test as the sole biomarker in the DETECSEPS study, a real-world evaluation using H3.1 in combination with the National Early Warning Score to promote the early detection of sepsis and try and promote the flow of patients through emergency rooms.

Speaker #3: As a result of this , convincing evidence , in December , we were delighted to announce the inclusion of our new Q nets test as the sole biomarker in the detect study , a real world evaluation using H 3.1 in combination with the National Early Warning Score to promote the early detection of sepsis and try and promote the flow of patients through emergency rooms .

Andy Retter: This is a problem every healthcare system in the world faces. Not only is DETECSEPS led by prominent clinicians, it is also backed with financing from the French government. DETECSEPS aligns with Volition's core purpose of operationalizing our understanding of epigenetics, and in particular of H3.1 in clinical practice, to help identify and monitor the severity of disease.

Speaker #3: This is a problem every healthcare system in the world faces. Not only is the tech set led by prominent clinicians, it is also backed with financing from the French government.

Speaker #3: The tech CEP aligns with Volition's core purpose of operationalizing our understanding of epigenetics, and in particular, of H3.1 in clinical practice to help identify and monitor the severity of disease.

Andrew Retter: The DETECSEPS program provides an opportunity to receive individualized care, adjusted to the risk of deterioration or risk of progression to multiple organ failure. It is a great privilege to be involved in such a program, and we hope that through earlier identification and risk stratification of patients, many lives can be saved. We also hope that by improving the flow of patients out of emergency rooms, that we can help hospitals run more efficiently, sending people home safely, escalating, and expediting care to those patients who need it most. These efficiency gains could be huge and have a real impact on the entire running of hospitals and improve the delivery of healthcare. I think you can understand why we say it has an impact in all healthcare settings.

Andy Retter: The DETECSEPS program provides an opportunity to receive individualized care, adjusted to the risk of deterioration or risk of progression to multiple organ failure. It is a great privilege to be involved in such a program, and we hope that through earlier identification and risk stratification of patients, many lives can be saved.

Speaker #3: The Detect Set program provides an opportunity to receive individualized care adjusted to the risk of deterioration or risk of progression to multiple organ failure.

Speaker #3: It is a great privilege to be involved in such a program, and we hope that through earlier identification and risk stratification of patients, many lives can be saved.

Andy Retter: We also hope that by improving the flow of patients out of emergency rooms, that we can help hospitals run more efficiently, sending people home safely, escalating, and expediting care to those patients who need it most. These efficiency gains could be huge and have a real impact on the entire running of hospitals and improve the delivery of healthcare. I think you can understand why we say it has an impact in all healthcare settings.

Speaker #3: We also hope that by improving the flow of patients out of emergency rooms, we can help hospitals run more efficiently, sending people home safely, and escalating and expediting care to those patients who need it most.

Speaker #3: These efficiency gains could be huge and have a real impact on the entire running of hospitals and improve the delivery of healthcare. I think you can understand why we say it has an impact in all healthcare settings.

Andrew Retter: A final exciting development in 2025 has the potential to be a game-changing technology, not only in disease where time is critical, such as sepsis, but also in providing our tests to lower-income countries where laboratory infrastructure may be weak or non-existent. Specifically, this is the development of a lateral flow test for point-of-care quantification of nucleosomes. In July 2025, we reported that a quantification of nucleosomes in whole blood in minutes utilizing a simple lateral flow device. I'm delighted to say the second phase of research is now well underway, with the first patient recruited for comparison between whole blood and capillary blood in critically ill patients. This really is a technology to watch out for in the coming months. Hot off the press, we are delighted to announce this week the publication of a study with our colleagues at the Mayo Clinic in the journal Shock.

Andy Retter: A final exciting development in 2025 has the potential to be a game-changing technology, not only in disease where time is critical, such as sepsis, but also in providing our tests to lower-income countries where laboratory infrastructure may be weak or non-existent. Specifically, this is the development of a lateral flow test for point-of-care quantification of nucleosomes. In July 2025, we reported that a quantification of nucleosomes in whole blood in minutes utilizing a simple lateral flow device.

Speaker #3: A final , exciting development in 2025 has the potential to be a game changing technology . Not only in disease where time is critical , such as sepsis , but also in providing our tests to lower income countries where laboratory infrastructure may be weak or non-existent .

Speaker #3: Specifically , this is the development of a lateral flow test for point of care , quantification of nucleosomes . In July 2025 , we reported that a quantification of nucleosomes in whole blood in minutes utilizing a simple lateral flow device .

Andy Retter: I'm delighted to say the second phase of research is now well underway, with the first patient recruited for comparison between whole blood and capillary blood in critically ill patients. This really is a technology to watch out for in the coming months. Hot off the press, we are delighted to announce this week the publication of a study with our colleagues at the Mayo Clinic in the journal Shock.

Speaker #3: I am delighted to say the second phase of research is now well underway, with the first patient recruited for comparison between whole blood and capillary blood in critically ill patients.

Speaker #3: This really is a technology to watch out for in the coming months, and hot off the press, we are delighted to announce this week the publication of a study with our colleagues at the Mayo Clinic in the journal Shock.

Andrew Retter: The Mayo Clinic study of 674 trauma patients demonstrated that nucleosome levels as measured by Volition's Nu.Q H3.1 and Nu.Q H3R8 Citrulline tests are elevated in people that go on to have complications from trauma. The identification of reliable biomarkers to trauma is a clinical challenge and remains a significant unmet need in the emergency and surgical settings. Professor Park, a principal investigator and senior author of the paper, said, "These biomarkers could aid in early risk identification and may inform targeted preventive strategies in trauma care." For my part, I believe this is a significant study not only for clinicians, patients, and their families, but also for Volition. A peer-reviewed publication with the Mayo Clinic research team strongly supports our efforts to commercialize our Nu.Q NETs products.

Andy Retter: The Mayo Clinic study of 674 trauma patients demonstrated that nucleosome levels as measured by Volition's Nu.Q H3.1 and Nu.Q H3R8 Citrulline tests are elevated in people that go on to have complications from trauma.

Speaker #3: The Mayo Clinic study of 674 trauma patients demonstrated that nucleosome levels, as measured by Volition's new QH3.1 and new QH3R8 Citrulline tests, are elevated in people that go on to have complications from trauma.

Andy Retter: The identification of reliable biomarkers to trauma is a clinical challenge and remains a significant unmet need in the emergency and surgical settings. Professor Park, a principal investigator and senior author of the paper, said, "These biomarkers could aid in early risk identification and may inform targeted preventive strategies in trauma care."

Speaker #3: The identification of reliable biomarkers in trauma is a clinical challenge and remains a significant unmet need in the emergency and surgical settings . Professor , Park , the principal investigator and senior author of the paper , said .

Speaker #3: These biomarkers could aid in early risk identification and may inform targeted preventive strategies in trauma care . For my part , I believe this is a significant study not only for clinicians , patients and their families , but also for volition .

Andy Retter: For my part, I believe this is a significant study not only for clinicians, patients, and their families, but also for Volition. A peer-reviewed publication with the Mayo Clinic research team strongly supports our efforts to commercialize our Nu.Q NETs products.

Speaker #3: A peer reviewed publication with the Mayo Clinic research team strongly supports our efforts to commercialize our new Q nets products . Indeed , my overall sentiment is that this study , together with our previously published evidence , demonstrates that new Q nets may enable clinicians and researchers to anticipate disease guide treatment decisions , understand disease trajectory and monitor patients over time across acute and chronic conditions .

Andrew Retter: Indeed, my overall sentiment is that this study, together with our previously published evidence, demonstrates that Nu.Q NETs may enable clinicians and researchers to anticipate disease, guide treatment decisions, understand disease trajectory, and monitor patients over time across acute and chronic conditions. Turning to Nu.Q Cancer and in particular lung cancer, where the first clinical use of Nu.Q is now imminent. Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring. Research conducted by our long-term collaborators in Taiwan and Lyon consistently demonstrates that our Nu.Q Cancer technology empowers clinicians to make informed treatment decisions and provides valuable new monitoring capabilities through the patient journey. From a publications perspective, the first NTU manuscript was published in March 2025, coincidentally almost the same day as the first patient was enrolled in their validation study.

Andy Retter: Indeed, my overall sentiment is that this study, together with our previously published evidence, demonstrates that Nu.Q NETs may enable clinicians and researchers to anticipate disease, guide treatment decisions, understand disease trajectory, and monitor patients over time across acute and chronic conditions. Turning to Nu.Q Cancer and in particular lung cancer, where the first clinical use of Nu.Q is now imminent.

Speaker #3: Turning to new Q cancer and in particular , lung cancer , where the first clinical use of new Q is now imminent , UQ cancer represents a significant advancement in lung cancer patient management , offering clinicians an additional tool to enhance precision in treatment selection and monitoring .

Andy Retter: Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring.

Andy Retter: Research conducted by our long-term collaborators in Taiwan and Lyon consistently demonstrates that our Nu.Q Cancer technology empowers clinicians to make informed treatment decisions and provides valuable new monitoring capabilities through the patient journey. From a publications perspective, the first NTU manuscript was published in March 2025, coincidentally almost the same day as the first patient was enrolled in their validation study.

Speaker #3: Research conducted by our long-term collaborators in Taiwan and Leon consistently demonstrates that our new Q cancer technology empowers clinicians to make informed treatment decisions and provides valuable new monitoring capabilities through the patient journey from a relations perspective.

Speaker #3: The first NTU manuscript was published in March 2025, coincidentally, almost the same day as the first patient was enrolled in their validation study.

Andrew Retter: The NTU team also presented data at the North America Conference on Lung Cancer in Chicago in December, and then as recently as last week's ESMO's European Lung Cancer Congress. Both posters support the use of Nu.Q Cancer preoperatively to help identify patients at high risk. High H3K27me3 levels predicted poorer recurrence-free, and overall survival outcome. Whereas a lower H3K27me3 level indicated a significantly better outcome. Joint lead author, Dr. Chen, commented that the Nu.Q Cancer technology supports a practical approach to empower clinicians to make a more informed treatment decision and provides valuable new monitoring capabilities throughout the patient journey. This is excellent endorsement indeed, and I know from the commercial team that they are now looking forward to how we can provide the test in routine clinical practice.

Andy Retter: The NTU team also presented data at the North America Conference on Lung Cancer in Chicago in December, and then as recently as last week's ESMO's European Lung Cancer Congress. Both posters support the use of Nu.Q Cancer preoperatively to help identify patients at high risk. High H3K27me3 levels predicted poorer recurrence-free, and overall survival outcome. Whereas a lower H3K27me3 level indicated a significantly better outcome.

Speaker #3: The NTU team also presented data at the North American Lung Cancer Conference in Chicago in December, and then, as recently as last week's SMS, European Lung Cancer Conquest.

Speaker #3: Both posters support the use of new Q cancer preoperatively to help identify patients at high risk. High H3K27 trimethyl nucleosome levels predicted poorer recurrence-free and overall survival outcomes, whereas a lower H3K27 trimethyl level indicated a significantly better outcome.

Andy Retter: Joint lead author, Dr. Chen, commented that the Nu.Q Cancer technology supports a practical approach to empower clinicians to make a more informed treatment decision and provides valuable new monitoring capabilities throughout the patient journey. This is excellent endorsement indeed, and I know from the commercial team that they are now looking forward to how we can provide the test in routine clinical practice.

Speaker #3: Joint lead author Dr. Chen commented that the new Q Cancer technology supports a practical approach to empower clinicians to make more informed treatment decisions and provides valuable new monitoring capabilities throughout the patient journey.

Speaker #3: This is excellent endorsement indeed , and I know from the commercial team that they are now looking forward to how we can provide the test in routine clinical practice , together with our colleagues in Lyon , we have also presented at a number of conferences and prepared a further two manuscripts for submission , review and publication , the first of which has just been submitted , and the second is due to be submitted in the coming weeks .

Andrew Retter: Together with our colleagues in Lyon, we've also presented at a number of conferences and prepared a further two manuscripts for submission, peer review, and publication. The first of which has just been submitted, and the second is due to be submitted in the coming weeks. These results demonstrate that measured methylated nucleosome biomarkers at non-small cell lung cancer diagnosis can provide valuable information about survival, progression-free survival, and crucially, help enhance the identification of patients who may benefit from more intensive therapy and potentially offer them curative care. As Cameron said at the top of the call, we made our first sale of our Nu.Q Cancer assays to the Hospices Civils de Lyon, one of Europe's leading cancer centers, and subsequent to year-end, we have announced with the support of our Lyon team, the preparation of our reimbursement submission to the French government.

Andy Retter: Together with our colleagues in Lyon, we've also presented at a number of conferences and prepared a further two manuscripts for submission, peer review, and publication. The first of which has just been submitted, and the second is due to be submitted in the coming weeks.

Andy Retter: These results demonstrate that measured methylated nucleosome biomarkers at non-small cell lung cancer diagnosis can provide valuable information about survival, progression-free survival, and crucially, help enhance the identification of patients who may benefit from more intensive therapy and potentially offer them curative care.

Speaker #3: These results demonstrate that measured methylated nucleotide biomarkers at non-small cell lung cancer diagnosis can provide valuable information about survival , progression free survival , and , crucially , help enhance the identification of patients who may benefit from more intensive therapy and potentially offer them curative care .

Andy Retter: As Cameron said at the top of the call, we made our first sale of our Nu.Q Cancer assays to the Hospices Civils de Lyon, one of Europe's leading cancer centers, and subsequent to year-end, we have announced with the support of our Lyon team, the preparation of our reimbursement submission to the French government.

Speaker #3: As Cameron said at the top of the call , we made our first sale of our new Q cancer assays to the hospice Civils de Lyon , one of Europe's leading cancer centers , and subsequent to year end , we have announced , with the support of our liaison team , the preparation of our reimbursement submission to the French government .

Andrew Retter: Reimbursement is the next step on the path to the first use of Nu.Q in clinical practice, an exciting prospect which is core to Volition's mission using our test to help save lives. Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q Cancer. Once achieved, we anticipate the introduction into routine clinical use in France by Q4 2026. This is a truly exciting and rewarding prospect. With that, I will pass you over to Jake, who will give you an update on another significant project. Thank you, everyone. Over to you, Jake.

Andy Retter: Reimbursement is the next step on the path to the first use of Nu.Q in clinical practice, an exciting prospect which is core to Volition's mission using our test to help save lives. Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q Cancer.

Speaker #3: Reimbursement is the next step on the path to the first use of new Q in clinical practice. An exciting prospect, which is core to Volition's mission.

Speaker #3: Using our test to help save lives, reimbursement will be a major milestone for Volition in the commercialization and licensing of new Q cancer.

Andy Retter: Once achieved, we anticipate the introduction into routine clinical use in France by Q4 2026. This is a truly exciting and rewarding prospect. With that, I will pass you over to Jake, who will give you an update on another significant project. Thank you, everyone. Over to you, Jake.

Speaker #3: Once achieved , we anticipate the introduction into routine clinical use in France by the fourth quarter of 2026 . This is a truly exciting and rewarding prospect , and with that , I will pass you over to Jake , who will give you an update on another significant project .

Speaker #3: Thank you, everyone. Over to you, Jake.

Jacob Micallef: Thanks very much, Andy. Hello, everyone. I'm just going to be talking about one project today, Capture-Seq, which we've had several announcements about, the first in December, and others in more recent weeks. Volition is, I believe, the first company to demonstrate the isolation and analysis of greater than 99% pure circulating tumor-derived DNA. To set the scene, the biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not from cancer cells. In a world-first new technology, Volition has overcome this hurdle and produced greater than 99% pure cancer-derived plasma DNA sequence sets for liquid biopsy. Our manuscript, submitted in November and previously announced in December 2025, described a new liquid biopsy chemistry for isolating CTC-cfDNA from plasma.

Jake Micallef: Thanks very much, Andy. Hello, everyone. I'm just going to be talking about one project today, Capture-Seq, which we've had several announcements about, the first in December, and others in more recent weeks. Volition is, I believe, the first company to demonstrate the isolation and analysis of greater than 99% pure circulating tumor-derived DNA. To set the scene, the biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not from cancer cells.

Speaker #4: Thanks very much , Andy , and hello everyone . I'm just going to be talking about one project today , Capture CIG , which we've had several announcements about .

Speaker #4: The first in December and others in more recent weeks . Volition is , I believe , the first company to demonstrate the isolation and analysis of greater than 99% pure circulating tumor derived DNA to set the scene .

Speaker #4: The biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not from cancer cells.

Jake Micallef: In a world-first new technology, Volition has overcome this hurdle and produced greater than 99% pure cancer-derived plasma DNA sequence sets for liquid biopsy. Our manuscript, submitted in November and previously announced in December 2025, described a new liquid biopsy chemistry for isolating CTC-cfDNA from plasma.

Speaker #4: In a world first , new technology , volition has overcome this hurdle and produced greater than 99% pure cancer derived plasma DNA sequence sets for biopsy .

Speaker #4: Our manuscript, submitted in November and previously announced in December 2025, described a new liquid biopsy chemistry for isolating CTCF DNA from plasma.

Jacob Micallef: Subsequently, our continuing work on CTC-cfDNA bound DNA has revealed what we believe to be an unprecedented new discovery, that there is almost no CTC-cfDNA bound DNA in healthy plasma and almost all CTC-cfDNA bound DNA in the blood of a cancer patient is derived from cancer cells, i.e., it is virtually pure circulating tumor-derived DNA. Removal of background normal cell-free DNA from the blood to reveal this level of tumor-derived DNA has been a long-term goal of liquid biopsy. In this updated manuscript, we report a new two-step method for preparing virtually pure circulating tumor DNA sets for cancer patients. The first step is the physical enrichment of the sample, and the second step is the bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set.

Jake Micallef: Subsequently, our continuing work on CTC-cfDNA bound DNA has revealed what we believe to be an unprecedented new discovery, that there is almost no CTC-cfDNA bound DNA in healthy plasma and almost all CTC-cfDNA bound DNA in the blood of a cancer patient is derived from cancer cells, i.e., it is virtually pure circulating tumor-derived DNA. Removal of background normal cell-free DNA from the blood to reveal this level of tumor-derived DNA has been a long-term goal of liquid biopsy.

Speaker #4: Subsequently , our continuing work on Ctcf bound DNA has revealed what we believe to be an unprecedented new discovery that there is almost no Ctcf bound DNA in healthy plasma and almost all ctcf bound DNA in the blood of a cancer patient is derived from cancer cells , i.e. it is virtually pure circulating tumor derived DNA .

Speaker #4: Removal of background , normal cell free DNA from the blood to reveal this level of tumor derived DNA has been a long term goal of liquid biopsy .

Jake Micallef: In this updated manuscript, we report a new two-step method for preparing virtually pure circulating tumor DNA sets for cancer patients. The first step is the physical enrichment of the sample, and the second step is the bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set.

Speaker #4: In this updated manuscript , we report a new two step method for preparing virtually pure circulating tumor DNA sets for cancer patients . The first step is the physical enrichment of the sample , and the second step is the bioinformatic removal of virtually all remaining non-tumor .

Speaker #4: cfDNA sequences from the DNA sequence data set. This new method produced more than 99% pure ctDNA sequencing data sets for blood samples from cancer patients.

Jacob Micallef: This new method produced more than 99% pure ctDNA sequencing data sets for blood samples from cancer patients. While we capture a subset of the circulating tumor DNA, not all of the circulating tumor DNA in a sample, it is virtually pure cancer DNA. These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers, representing, in my opinion, the biggest scientific breakthrough in cancer testing and monitoring in recent years. Last week, we released data from a blinded validation cohort of 81 subjects, including 59 colorectal and lung cancer patients and 22 healthy controls. We were extremely encouraged by the results, particularly in early-stage cancer, where we detected more than 95% of stage 1 and stage 2 cancers. For patients, the potential significance is huge.

Jake Micallef: This new method produced more than 99% pure ctDNA sequencing data sets for blood samples from cancer patients. While we capture a subset of the circulating tumor DNA, not all of the circulating tumor DNA in a sample, it is virtually pure cancer DNA.

Speaker #4: And whilst we capture a subset of the circulating tumor DNA, not all of the circulating tumor DNA in a sample, it is virtually pure cancer DNA.

Jake Micallef: These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers, representing, in my opinion, the biggest scientific breakthrough in cancer testing and monitoring in recent years.

Speaker #4: These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequenced biomarkers, representing, in my opinion, the biggest scientific breakthrough in cancer testing and monitoring in recent years.

Jake Micallef: Last week, we released data from a blinded validation cohort of 81 subjects, including 59 colorectal and lung cancer patients and 22 healthy controls. We were extremely encouraged by the results, particularly in early-stage cancer, where we detected more than 95% of stage 1 and stage 2 cancers. For patients, the potential significance is huge.

Speaker #4: Last week , we released data from a blinded validation cohort of 81 subjects , including 59 colorectal and lung cancer patients and 22 healthy controls , and we were extremely encouraged by the results , particularly in early stage cancer , where we detected more than 95% of stage one and stage two cancers for patients .

Speaker #4: The potential significance is huge . If validated in larger cohorts . Ctcf capture seq could contribute to multicancer early detection , fulfilling a significant unmet clinical need .

Jacob Micallef: If validated in larger cohorts, CTCF Capture-Seq could contribute to multi-cancer early detection, fulfilling a significant unmet clinical need. We also believe Capture-Seq has the potential to play a role in cancer management, including but not limited to minimal residual disease detection, including tumor-naive minimal residual disease detection and treatment monitoring, either alone or potentially in combination with other technologies. Volition is, I believe, the first liquid biopsy company to focus on circulating cell-free nuclear proteins. We have filed a number of new patents to protect this technology. As you can imagine, this has generated a lot of interest, and we're in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development and launch of this technology as soon as possible. With that, I'll pass over to Cameron for his commercial perspective and wrap-up. Cameron.

Jake Micallef: If validated in larger cohorts, CTCF Capture-Seq could contribute to multi-cancer early detection, fulfilling a significant unmet clinical need. We also believe Capture-Seq has the potential to play a role in cancer management, including but not limited to minimal residual disease detection, including tumor-naive minimal residual disease detection and treatment monitoring, either alone or potentially in combination with other technologies.

Speaker #4: We also believe capture sake has the potential to play a role in cancer management , including , but not limited to , minimal residual disease detection , including tumor naive minimal residual disease detection , and treatment monitoring .

Speaker #4: Either alone or potentially in combination with other technologies . VOLITIONRX LTD . I believe the first liquid biopsy company to focus on circulating cell free nuclear proteins , and we have filed a number of new patents to protect this technology .

Jake Micallef: Volition is, I believe, the first liquid biopsy company to focus on circulating cell-free nuclear proteins. We have filed a number of new patents to protect this technology. As you can imagine, this has generated a lot of interest, and we're in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development and launch of this technology as soon as possible. With that, I'll pass over to Cameron for his commercial perspective and wrap-up. Cameron.

Speaker #4: As you can imagine, this has generated a lot of interest. And we're in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development and launch of this technology.

Speaker #4: As soon as possible. And with that, I'll pass over to Kamran for his commercial perspective and wrap-up, Cameron.

Cameron Reynolds: Thanks, Jake, and let me start by congratulating you, Andy, and the whole innovation, research, and development, and the clinical teams on the truly amazing progress you have made, not only this year, but over the last 15 years. We set out to help save lives and improve outcomes for millions of patients worldwide, and we're making huge progress towards that goal. With the first clinical use now imminent in both early sepsis detection and lung cancer management, we are about to be part of the solution through simple, easy-to-use, low-cost tests. Our vision is for our technologies to be incorporated into tests that will be used first by millions and ultimately hundreds of millions of people and animals a year. With our platform licensed to a range of large diagnostic and liquid biopsy companies and governments worldwide.

Speaker #5: Thanks , Jake . And let me start by congratulating you , Andy in the whole innovation , research and development and clinical teams on the truly amazing progress you have made .

Speaker #5: Not only this year, but over the last 15 years, we set out to help save lives and improve outcomes for millions of patients worldwide, and we're making huge progress towards that goal.

Cameron Reynolds: With the first clinical use now imminent in both early sepsis detection and lung cancer management, we are about to be part of the solution through simple, easy-to-use, low-cost tests. Our vision is for our technologies to be incorporated into tests that will be used first by millions and ultimately hundreds of millions of people and animals a year. With our platform licensed to a range of large diagnostic and liquid biopsy companies and governments worldwide.

Speaker #5: With the first clinical use . Now imminent in both early sepsis detection and lung cancer management , we are about to be part of the solution through simple , easy to use , low cost tests .

Speaker #5: Our vision is for our technologies to be incorporated into tests that will be used first by millions, and ultimately hundreds of millions, of people and animals.

Speaker #5: A year . With our platform license to a range of large diagnostic and liquid biopsy companies and governments worldwide . Combining our groundbreaking technology with their installed base of labs , analyze machines and sales forces around the world , we will achieve the optimal outcome for us large companies have the resources to realize the opportunities better than volition .

Cameron Reynolds: Combining our groundbreaking technology with their installed base of labs, analyzer machines, and sales forces around the world, we will achieve the optimal outcome for us. Large companies have the resources to realize the opportunities better than Volition. The total addressable market, TAMs, for our technologies on an annualized basis are multibillion-dollar opportunities, not only for Volition, but for our licensing partners too. Volition has made strong progress both clinically and commercially. Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vet market, and anticipate, similar to the vet market, diverse deal structures with potential for upfront and milestone payments and recurring revenue. As mentioned earlier, we are continuing our discussions with around 10 of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the negotiation process across all our pillars.

Speaker #5: The total addressable markets, TAMs, for our technologies on an annualized basis are multi-billion dollar opportunities, not only for Volition, but for our licensing partners too.

Speaker #5: Volition has made strong progress both clinically and commercially . Our goal is to secure a wide range of licensing agreements in the human diagnostic space , mirroring our successful strategy in the Vet market and anticipate , similar to the vet market , diverse deal structures with potential for upfront and milestone payments and recurring revenue .

Cameron Reynolds: Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vet market, and anticipate, similar to the vet market, diverse deal structures with potential for upfront and milestone payments and recurring revenue. As mentioned earlier, we are continuing our discussions with around 10 of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the negotiation process across all our pillars.

Speaker #5: As mentioned earlier, we are continuing our discussions with around ten of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the negotiation process across all our pillars.

Cameron Reynolds: Our laser focus is on executing licensing agreements, and we will update you as they complete. Thank you for joining our call today. We very much appreciate it. We will now take your questions. Operator?

Speaker #5: Our laser focus is on executing licensing agreements, and we will update you as they complete. Thank you for joining our call today.

Speaker #5: We very much appreciate it. We will now take your questions, Operator.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Justin Walsh with JonesTrading. Please proceed.

Speaker #1: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question.

Speaker #1: You may press star two if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Justin Walsh with Jones Trading.

Speaker #1: Please proceed

Justin Walsh: Hi, thanks for taking the question. As we see more from Capture-Seq, it would be great if you could provide some additional color on the current state of the liquid biopsy field, where maybe the field has seen some success and where alternative approaches have fallen short. Then maybe related to this, some takeaways on the failure of the large NHS Galleri trial to achieve its primary endpoint.

Speaker #6: Hi . Thanks for taking the question . As we see more from capture , it would be great if you could provide some additional color on the current state of the liquid biopsy field , where maybe the field has seen some success and where alternative approaches have fallen short .

Speaker #6: And then, maybe related to this, some takeaways on the failure of the large NHS GALLERI trial to achieve its primary endpoint.

Cameron Reynolds: Yeah. We tend not to criticize the other companies. I mean, they're often well-run companies with good people trying to do good things. I think it's very fair to say, from our discussions with everyone, no one out there thinks their current testing modality is where they really need it to be in early-stage detection for multi-cancer detection or in MRD for treatment naive. That's obviously not something either. There is 100% an opportunity for anyone who can develop something which is truly routine, which ours is, low cost and easy to use, which ours is, and certainly appears to be very accurate. We're doing more and more studies, but the early work is incredibly encouraging.

Speaker #5: Yes . So we tend not to criticize the other companies . I mean , they're often well run companies with good people trying to do good things .

Speaker #5: But I think it's very fair to say, based on our discussions with everyone, no one out there really thinks their current testing modality is where they need it to be for early-stage detection for multi-detection, or with an MRI for treatment.

Cameron Reynolds: That's obviously not something either. There is 100% an opportunity for anyone who can develop something which is truly routine, which ours is, low cost and easy to use, which ours is, and certainly appears to be very accurate. We're doing more and more studies, but the early work is incredibly encouraging.

Speaker #5: Naive . That's obviously not something either . So there is 100% an opportunity for anyone who can develop something which is truly routine , which ours is low cost and easy to use , which ours is and certainly appears to be very accurate .

Speaker #5: We're doing more and more studies , but the early work is incredibly encouraging . So I think , you know , in any space , like cancer detection , there's going to be a number of parties .

Cameron Reynolds: I think, you know, in any space like cancer detection, there is going to be a number of parties. No company, no matter how good the technology, will be everything. I think there's a very strong case to be made, we will be a big part of cancer detection in the human space like we are in the vet space, starting with the fantastic lung work, which is in the process of being reimbursed, which is incredibly encouraging. Of course, the strong promise we have from Nu.Q Capture, which could either be used in conjunction with what's currently used, or potentially a test in itself. Given the early stage detection that we've shown, that's certainly a possibility.

Speaker #5: No company, no matter how good the technology will be, is everything. But I think there's a very strong case to be made.

Speaker #5: We will be a big part of cancer detection in the human space , like we are in the vet space , starting with the fantastic lung work , which is in the process of being reimbursed , which is incredibly encouraging .

Cameron Reynolds: Of course, the strong promise we have from Nu.Q Capture, which could either be used in conjunction with what's currently used, or potentially a test in itself. Given the early stage detection that we've shown, that's certainly a possibility.

Speaker #5: And of course, the strong promise we have from you to capture, which could either be used in conjunction with what's currently used or potentially as a test in itself. And given the early-stage detection that we've shown, that's certainly a possibility.

Cameron Reynolds: Overall, I think we've got something which is very special in what we do, and we're working with a number of groups now. Obviously we can't say who they are, it's confidential. We have a lot of active discussions going. These are things which are far bigger than we can commercialize ourselves. The bigger companies certainly have the installed capacity or the knowledge in particular areas like screening and MRD. We'll be updating as those hopefully come to fruition, hopefully in the more near term. We're expecting a lot of news on that through the year. As far as individual ones go, I guess you can read the news. There's been a lot of things which have not turned out exactly how they wanted.

Speaker #5: So overall, I think we've got something which is very special in what we do. And we're working with a number of groups now.

Speaker #5: Obviously , we can't say who they are . It's confidential , but we have a lot of active discussions going . These are things which are far bigger than we can commercialize ourselves .

Speaker #5: And the bigger companies certainly have the installed capacity or the knowledge in particular areas like screening and MRI. So we'll be updating as those, hopefully, come to fruition.

Cameron Reynolds: We'll be updating as those hopefully come to fruition, hopefully in the more near term. We're expecting a lot of news on that through the year. As far as individual ones go, I guess you can read the news. There's been a lot of things which have not turned out exactly how they wanted.

Speaker #5: Hopefully in the near term. And we're expecting a lot of news on that through the year. But as far as individual ones go, I guess I read the news.

Speaker #5: There have been a lot of things that have not turned out exactly how they wanted. But you know, we always say we will succeed if we deliver a good platform.

Cameron Reynolds: You know, we always say we will succeed if we deliver a good platform. We haven't spent a lot of time concerned about everybody else. There's always gonna be a place for a routine, accurate, low-cost test, and that's exactly what we think we've developed. We're working hard on commercializing.

Speaker #5: So we haven't spent a lot of time concerned about everybody else . There's always going to be a place for a routine , accurate , low cost test .

Speaker #5: And that's exactly what we think we would develop. So we're working hard on commercializing.

Justin Walsh: Thanks for taking the question.

Speaker #6: Thanks for taking the question .

Cameron Reynolds: Thank you, Justin.

Speaker #5: Thank you . Justin

Operator: Our next question is from Yi Chen with H.C. Wainwright. Please proceed.

Speaker #1: Our next question is from Yi Chen with H.C. Wainwright. Please proceed.

Yi Chen: Thank you for taking my questions. My first question is, could you comment on how do you expect the Nu.Q Cancer assays to ramp up in terms of volume throughout 2026? My second question is, can you just provide some general comments on how many new licensing deals you expect to close this year? Thank you.

Speaker #7: Thank you for taking my questions. My first question is: could you comment on how you expect the new COO cancer assays to run in terms of volume throughout 2026?

Speaker #7: And my second question is, can you just provide some general comments on how many new licensing deals you expect to close this year?

Speaker #7: Thank you .

Cameron Reynolds: I'll start with the deals. The first question, I didn't quite understand. So can you repeat the first question, please, Yi?

Speaker #5: I'll start with the deals. And the first question, I didn't quite understand. So, can you repeat the first question, please?

Yi Chen: How do you expect the volume of Nu.Q Cancer assays to ramp up through 2026?

Speaker #5: You .

Speaker #7: Oh, how do you expect the volume of the new Q cancer assays to ramp up through 2026?

Cameron Reynolds: Okay. I'll allow the CFO to answer that. I'll deal with the deals. Look, it's very hard to know. We've signed several in the human space already with fantastic companies. We're working with three multi-billion-dollar companies in the human space now. Revvity has launched a CE Mark kit in Europe on its platform. Revvity, the PerkinElmer, obviously a very large company. They very much like what we do. We're working with Hologic on the Discover side, on the marketing, which is very exciting. We're working with Werfen now on the NET kit and the process. If you look at each individual area, I think ultimately the NET test will be something that's extremely widely used. The uses, as we've said, go way beyond the massive market of sepsis.

Speaker #5: Okay , I'll allow the CFO to answer that . I'll deal with the deals . Look , it's very hard to know . We've signed several in the human space already with fantastic companies .

Speaker #5: We're working with three multi-billion dollar companies in the human space now; it has launched a key market in Europe on its platform revenue. PerkinElmer, obviously a very large company, they very much like what we do.

Cameron Reynolds: We're working with Hologic on the Discover side, on the marketing, which is very exciting. We're working with Werfen now on the NET kit and the process. If you look at each individual area, I think ultimately the NET test will be something that's extremely widely used. The uses, as we've said, go way beyond the massive market of sepsis.

Speaker #5: We're working with Hologic on the discover side, on the marketing, which is very exciting. And we're working with Werfen now on the next kit and the process.

Speaker #5: So, if you look at each individual area, I think ultimately the NETs test will be something that's extremely widely used, and the uses, as we've said, go way beyond the massive market of sepsis.

Cameron Reynolds: Just yesterday, I believe it was yesterday anyway, these last few days, we announced the Mayo Clinic results, which show, if you've had trauma, a very elevated level. I mean, have a look at the numbers, it's quite spectacular. Very elevated level if you've had trauma. Even higher, I mean, very, very high, you can go through the numbers again in the paper, if you've had VTE. Trauma is one of the biggest, well, it's the highest cause of death of people below 50 in the world and one of the major causes of admission to emergency. Another massive use for our NET test. Deal-wise, there's all the NET tests. We're talking to several companies now on the capture side, which is obviously very exciting.

Speaker #5: Just yesterday , I believe it was yesterday . Anyway , the last few days we announced the Mayo Clinic results , which show if you've had trauma , a very elevated level , have a look at the numbers .

Speaker #5: It's quite spectacular , very elevated level . If you've had trauma and even higher and I mean very , very high , you can go through the numbers again in paper .

Speaker #5: If you've had v e t and trauma is one of the biggest . Well , highest cause of death of people below 50 in the world .

Cameron Reynolds: Trauma is one of the biggest, well, it's the highest cause of death of people below 50 in the world and one of the major causes of admission to emergency. Another massive use for our NET test. Deal-wise, there's all the NET tests. We're talking to several companies now on the capture side, which is obviously very exciting.

Speaker #5: And one of the major causes of admission to emergencies . So another massive use for our next test . So deal wise , there's all the net tests we're talking .

Speaker #5: Several companies are now on the capture side, which is obviously very exciting. The governments are working on the lung cancer monitoring side, as you know.

Cameron Reynolds: The governments are working on the lung cancer monitoring side, as you know. It's hard to say which of the 10 or so companies will be first and what the order will and how many there will be. I think I'd strongly suggest we will have multiple deals with different companies, different governments, this year. I think it'll be across cancer and probably NET as well. We're also working with groups on our recombinant nucleosomes and on Discover. Don't forget, we do have 100 clients in Nu.Q Discover now, and some of those are coming to the stage where they're gonna become quite large in process, where they come into clinical studies, where they become very serious amounts of revenue.

Speaker #5: So, it's hard to say which of the ten or so companies will be first, and what the order will be, and how many there will be.

Speaker #5: But I think I'd strongly suggest we will have multiple deals with different companies, different governments this year. And I think it'll be across cancer and probably NETs as well.

Cameron Reynolds: I think it'll be across cancer and probably NET as well. We're also working with groups on our recombinant nucleosomes and on Discover. Don't forget, we do have 100 clients in Nu.Q Discover now, and some of those are coming to the stage where they're gonna become quite large in process, where they come into clinical studies, where they become very serious amounts of revenue.

Speaker #5: And then we're also working with groups on our recombinant nucleosomes and on Discover. And don't forget, we do have 100 clients in the UK.

Speaker #5: Discover now, and some of those are coming to the stage where they're going to become quite large in process, where they come into clinical studies, where they've become very serious amounts of revenue.

Cameron Reynolds: Overall, I can't give you an exact number, but I'm sure I'm quite certain we'll have deals, and we're trying to get them out as quickly as possible because we basically stopped the R&D side and we're now on just commercialization because we have an absolute mountain of opportunities in all the pillars, and we're very happy with how those deals are progressing. The volume, Terry?

Speaker #5: So overall , I can't give you an exact number , but I'm sure I'm quite certain we'll have have deals and we're trying to get them out as quickly as possible because we , we basically stopped the R&D side and we're now on just commercialization because we have an absolute mountain of opportunities in all the pillars .

Speaker #5: And we're very happy with how those deals are progressing and the volume . Tarik . Yeah . So I think as as Cameron mentioned earlier , we're we're in the process of for submission preparation for the reimbursement .

Terig Hughes: Yeah. I think as Cameron mentioned earlier, we're in that process of the submission preparation for the reimbursement. Yeah, that's obviously an H2 event in terms of approval of that. We'd expect to be at Q4 by the time we get a reimbursed product into routine clinical use. We haven't built a huge amount in this year given the timing, but we would expect it to ramp fairly quickly once it's in routine clinical use.

Speaker #5: Yeah , that's obviously that's an H2 event in terms of approval of that . And , and so we'd expect it to be Q4 by the time we get reimbursed product into routine clinical use .

Speaker #5: So, we haven't built a huge amount in this year given the timing. But we would expect it to ramp fairly quickly once it's in routine clinical use.

Cameron Reynolds: The Nu.Q NETs now is in IVDD, in the process of being IVDR. We're recording some revenue for that, but at the moment, we're not providing guidance to be conservative. Obviously, there's a lot of things happening, and they're all moving forward. Exactly when in the year it happens obviously will greatly affect when they'll start recurring revenue. They're all making progress, and they'll all be coming on stream, we think, in the next few quarters.

Speaker #5: And the new QNETs now is involved in the process of being ABDR. So we're recording some revenue for that. But at the moment, we're not providing guidance to be conservative.

Speaker #5: Obviously , there's a lot of a lot of things happening and they're all moving forward . But exactly when the year it happens , obviously will greatly affect when they can start recurring revenue .

Speaker #5: But they're all making progress, and they'll all be coming on stream. We think, in the next few quarters.

Yi Chen: Thank you.

Speaker #7: Thank you .

Cameron Reynolds: Thank you, Yi.

Speaker #5: Thank you .

Operator: Our next question is from Steven Ralston with Zacks. Please proceed.

Speaker #1: Our next question is from Steven Ralston with Zacks. Please proceed.

Steven Ralston: Good morning or good evening, as the case may be.

Speaker #8: Good morning, or good evening, as the case may be. I’d like to look into the revenue streams that you expect from the different pillars going forward, and it seems to be quite complex because there are different avenues in each area.

Cameron Reynolds: Good morning.

Steven Ralston: I'd love to look into the revenue streams that you expect from the different pillars going forward. It seems to be quite complex because there are different avenues in each area. The one in Nu.Q Vet is developed, and it's basically dependent on the partners and how successful they are in their different geographic regions. Can you make a comment on the rate of acceptance of the vet test for canines among the different partners you have? Are there any commonalities of the more successful ones of how they've ramped up usage?

Speaker #8: The one in New Cuvette is developed, and it's basically dependent on the partners and how successful they are in their different geographic regions. Can you make a comment on the rate of acceptance of the Vet test?

Speaker #8: The for canines among the different partners you have , and are there any commonalities of . The more successful ones , how they've ramped up usage ?

Cameron Reynolds: I think there's several different partners there. Between all of them, the one strong message we got. Obviously our revenue is growing, but which in a normal company, 40% would be very good, but obviously, we're looking for a lot more than that to really ramp. The key message from all of them, the key to that is to have it in a centralized lab. Currently, the vast majority of market, like over 80% of testing in dogs, is done through a centralized lab. The only option currently we have available in centralized labs, up until a few weeks ago, was microtiter plates, the plastic plates. Obviously that's not great if you're trying to do millions of tests.

Speaker #5: Yeah , so I think there's several different partners there . I think so between all of them , the one strong message we got , so obviously our revenue is growing , but which in a normal company , 40% would be very good .

Speaker #5: But obviously, we're looking for a lot more than that to really ramp the key message from all of them. The key to that is to have it in a centralized lab.

Cameron Reynolds: Currently, the vast majority of market, like over 80% of testing in dogs, is done through a centralized lab. The only option currently we have available in centralized labs, up until a few weeks ago, was microtiter plates, the plastic plates. Obviously that's not great if you're trying to do millions of tests.

Speaker #5: Currently , the vast majority of the market , like over 80% of testing in dogs , is done through a centralized lab . The only option currently , we have available in centralized lab up until a few weeks ago was microtitre plates .

Speaker #5: The plastic plates . So obviously that's not great if you're trying to do millions of tests . A centralized hospital network , and there are several in the US and foreign , you could get hundreds of thousands or millions of tests per network if it's part of a wellness panel or what they call the index of individuality .

Cameron Reynolds: A centralized hospital network, and there are several in the US and foreign. You could get hundreds of thousands or millions of tests per network if it's part of a wellness panel or what they call the index of individuality. We obviously have not cracked them yet, and a key part of that is the acceptance, but also being able to run, you know, maybe potentially hundreds of thousands of tests per month. You've probably noticed, Fujifilm, who've been fantastic partners and very proactive, have shown it now works on the centralized lab. The fantastic Revvity machine, which we're now using also for NETosis in Europe, the CE-marked machine, the same one. That'll start flowing through.

Speaker #5: We obviously have not cracked them yet . And a key part of that is the acceptance . But also being able to run , you know , maybe potentially hundreds of thousands of tests per month .

Cameron Reynolds: You've probably noticed, Fujifilm, who've been fantastic partners and very proactive, have shown it now works on the centralized lab. The fantastic Revvity machine, which we're now using also for NETosis in Europe, the CE-marked machine, the same one. That'll start flowing through.

Speaker #5: So you've probably noticed Fuji have been fantastic partners and very proactive . Have shown it now works on the centralized lab . The fantastic remedy machine , which we're now using also for Netosis in Europe , the key marked machine , the same one .

Speaker #5: So that'll start flowing through . So it comes down to , you know , it's lumpy between quarter and quarter . And when they order a batch and when they don't , because the plates can last up to a year , obviously , antique is also launched .

Cameron Reynolds: It comes down to, you know, it's lumpy between quarter and quarter and when they order a batch and when they don't, 'cause the plates can last up to a year. Obviously, Antech has also launched the small machine, but that's also subject to them selling and getting those machines in lots of different places. That's not gonna be an exponential growth by any means. It has come down to that. Don't forget also we are now working on felines, which potentially, I don't think will actually double the market, but theoretically it doubles the market 'cause there's more cats than dogs in the world. That's making good progress. Obviously, we've got Nu.Q Capture, which potentially has uses in all this as well.

Speaker #5: The small machine, but that's also subject to selling and getting those machines in lots of different places. So that's not going to be an exponential growth by any means.

Speaker #5: So it has come down to that . But don't forget also , we are now working on felines , which potentially I don't think will actually double the market , but theoretically it doubles the market because there's more cats and dogs in the world and that's making good progress .

Cameron Reynolds: Don't forget also we are now working on felines, which potentially, I don't think will actually double the market, but theoretically it doubles the market 'cause there's more cats than dogs in the world. That's making good progress. Obviously, we've got Nu.Q Capture, which potentially has uses in all this as well.

Speaker #5: And obviously we've got new Q Capture, which potentially has uses in all this as well. So there's a lot of things going on in vet, and it's very hard to predict, once you know, if and when a centralized lab system in the US goes for the centralized machine.

Cameron Reynolds: There's a lot of things going on in vet, and it's very hard to predict once, you know, if and when a centralized lab system in the US goes for the centralized machine. I think that's something that could then accelerate very quickly. In the meantime, it's kind of lumpy and bumping along at a, you know, the rates of growth you can see. It's hard to tell. Our commercialization efforts in the last six months are very much focused on the human space. We're extremely keen, you know, lung reimbursement. In Europe, that's EUR 50 per test. That's a lot more per test as well. Once it's approved, and we expect it to be by the end of this year, then obviously that's a very good revenue source.

Speaker #5: I think that's something that could then accelerate very quickly . But in the meantime , it's kind of lumpy and bumping along at a , you know , the rates of growth .

Speaker #5: You can see, so it's hard to tell. But our commercialization efforts in the last six months have very much focused on the human space.

Cameron Reynolds: Our commercialization efforts in the last six months are very much focused on the human space. We're extremely keen, you know, lung reimbursement. In Europe, that's EUR 50 per test. That's a lot more per test as well. Once it's approved, and we expect it to be by the end of this year, then obviously that's a very good revenue source.

Speaker #5: We're extremely keen, you know, on lung reimbursement in Europe. That's €50 per test. That's a lot more per test as well.

Speaker #5: And if it's at once, it's approved, we expect it to be by the end of this year. Then obviously that's a very good revenue source.

Cameron Reynolds: The CE mark kits are out there, so we spend a lot of effort changing from IVDD to IVDR, so it extends indefinitely from the time limits we currently have. Of course, we've put a lot of effort into licensing Nu.Q Capture. The vet has not been the focus of the company, but it's obviously important to keep it ticking over. We have made progress in the cats and the centralized labs, and we're looking perhaps even for transcription factors in dogs and cats.

Speaker #5: And the C mark kits are out there. So we've spent a lot of effort changing from IBD's IVR. So it stands indefinitely from the time limits.

Speaker #5: We currently have . And of course , we've put a lot of effort into licensing new Q capture . So the vet has not been the focus of the company , but it's obviously important to keep it ticking over .

Speaker #5: But we have made progress in the cats in the centralized labs, and we're looking perhaps even for transcription factors in dogs and cats.

Steven Ralston: Now, you even went into an area that I wanted to ask you about next, is that in Europe, you seem to have a very strong foothold with these hospital networks in the areas of sepsis and,

Speaker #8: Oh , you even went into an area that I wanted to ask you about . Next . Is that in Europe , you seem to have a very strong foothold with these hospital networks in the areas of sepsis and lung cancer .

Cameron Reynolds: Yeah.

Steven Ralston: lung cancer.

Cameron Reynolds: Yep.

Speaker #8: Yep . Is that is that a model for the for your global emphasis , or it just happens to be that this is the first foray

Steven Ralston: Is that a model for your global emphasis? Or it just happens to be that this is the first foray?

Cameron Reynolds: A bit of everything. Ultimately, what we have in Europe is a fantastic large multinational company in Revvity, which is the old PerkinElmer, who have a machine which our test works on very well. They've undertaken to put it in lots of different locations. There's over a dozen large hospital networks which are testing. Our CE mark is any NETs-related inflammation, so that's obviously a lot of different things. You just seen the Mayo Clinic, that also involves trauma, and trauma is potentially as big as everything else. It's quite remarkable how versatile it is. As Volition, we don't wanna be doing 10 studies in trauma, in sepsis, in COVID, in APS, in HS, all those things.

Speaker #5: A bit of everything . So ultimately what we have in Europe is a fantastic large multinational company in which they . Old PerkinElmer , who have a machine which our test works on very well .

Speaker #5: They've undertaken to put it in lots of different locations. There are over a dozen large hospital networks which are testing. So our Cmarq is any NETs-related inflammation.

Cameron Reynolds: Our CE mark is any NETs-related inflammation, so that's obviously a lot of different things. You just seen the Mayo Clinic, that also involves trauma, and trauma is potentially as big as everything else. It's quite remarkable how versatile it is. As Volition, we don't wanna be doing 10 studies in trauma, in sepsis, in COVID, in APS, in HS, all those things.

Speaker #5: So, that's obviously a lot of different things. You just saw the Mayo Clinic—that also involves trauma, and trauma is potentially as big as everything else.

Speaker #5: It's quite remarkable how versatile it is . But as volition , we don't want to be doing ten studies in trauma , in sepsis , in Covid , in APS , in HHS , all those things .

Cameron Reynolds: We've shifted a lot to our partners doing the work, like Werfen, for example, in inflammatory diseases, like all the companies doing it in the process. We are also looking for a large or several large diagnostic companies to, you know who the large diagnostic companies are, to take it on. I think as Andy said, the evidence is getting more and more overwhelming that NETs is gonna be a very large product. If you take all the issues in sepsis, all the issues in all the autoimmune diseases, add in trauma, and COVID, it's just obviously huge. It's been part of our strategy to get other people to buy our kits and do these studies. The only issue, it just takes their own time, but we're not spending.

Speaker #5: So we've shifted a lot to our partners doing the work like Werfen , for example , in inflammatory diseases , like all the companies doing it in the process .

Speaker #5: So we are also looking for a large or several large diagnostic companies to , you know , who large diagnostic companies are to take it on .

Speaker #5: And I think , as Andy said , the evidence is getting more and more overwhelming that nets is going to be a very , very , very large product .

Cameron Reynolds: If you take all the issues in sepsis, all the issues in all the autoimmune diseases, add in trauma, and COVID, it's just obviously huge. It's been part of our strategy to get other people to buy our kits and do these studies. The only issue, it just takes their own time, but we're not spending.

Speaker #5: So if you take all the issues in sepsis, all the issues in all the diseases, add in trauma and COVID, it's just obviously a huge—

Speaker #5: So, it's been part of our strategy to get other people to buy our kits and do these studies. The only issue is it just takes their own time.

Speaker #5: But we're not spending. But I think that the big, the big daddy of all those is the French government, which has spent seven, eight million.

Cameron Reynolds: I think the big daddy of all those is the French government, which has spent $7 or 8 million, whatever it is, on an interventional study to test and hopefully launch our product as the screening test in France, in conjunction with NEWS, which are the physical symptoms, the non-biomarkers. Now, if that does go well, I think there's a very good chance it will, we won't know till the end, but we've seen it work very well in sepsis. We will become the test in France, which I think then will become the test in Europe. Then it becomes extremely easy to license to a large international diagnostics to do a 510(k) in the US, to also launch there.

Speaker #5: Whatever it is on an interventional study to test and hopefully launch our product as the screening test in France , in conjunction with news , which are the physical symptoms , the non biomarkers .

Cameron Reynolds: Now, if that does go well, I think there's a very good chance it will, we won't know till the end, but we've seen it work very well in sepsis. We will become the test in France, which I think then will become the test in Europe. Then it becomes extremely easy to license to a large international diagnostics to do a 510(k) in the US, to also launch there.

Speaker #5: Now , if that does go well and I think there's a very good chance it will we won't know till the end . But we've seen it work very well in sepsis .

Speaker #5: We will become the test in France , which I think then will become the test in Europe . And then it becomes extremely easy to license to a large international diagnostics , to do a five 10-K in the US to also launch there .

Cameron Reynolds: Our strategy has been develop the platform, make sure it's incredibly robust, reproducible, reliable. Make sure it's certified, which it is now on the first platform. Get other people to do the work, and I think that's been a tremendous success. Get them to do the legwork to show what the cut off should be. It fits in with our global strategy. Now we're working with the big diagnostic companies to get the first one of them to license on their large auto analyzer machines beyond the Revvity machine that we have now. Does that answer your question, Steven?

Speaker #5: So our strategy has been developed . The platform , make sure it's incredibly robust , reproducible , reliable , make sure it's certified , which it is .

Speaker #5: Now on the first platform . Get other people to do the work . And I think that's been a tremendous success . And get them to do the the legwork to show what the cutoff should be .

Speaker #5: So it fits in with our global strategy. And now we're working with the big diagnostic companies to get the first one of them to license on their large autoanalyzer machines, beyond the riveting machine that we have now. Does that answer your question, Stephen?

Cameron Reynolds: Now we're working with the big diagnostic companies to get the first one of them to license on their large auto analyzer machines beyond the Revvity machine that we have now. Does that answer your question, Steven?

Steven Ralston: Oh, yes, very much so. Thank you for taking my questions.

Speaker #8: Oh, yes, very much so. Thank you for taking my questions.

Cameron Reynolds: Yeah. Just on a personal note, just to finish, I think it's incredibly gratifying. I don't know if everyone understands necessarily. An interventional study means it's used on real people in real life, and those decisions are taken based on our test, and that's gonna be this year when the study starts. That's the confidence they have in the test. This is not a university exercise or someone doing some blood, you know, some samples from the freezer. It's an interventional study, and I don't quite know how much that would cost in the US. We didn't get it costed, but it's an awful lot more than the EUR 8 million I think the French government's spending on it to do it, say, in the US.

Speaker #5: Yeah . And just on a personal note , just to finish , I think it's incredibly gratifying . I don't know if everyone understands necessarily an interventional study means it's used on real people in real life .

Speaker #5: And those decisions are taken based on our tests. And that's going to be this year when the study starts. So that's the confidence they have in the test.

Cameron Reynolds: This is not a university exercise or someone doing some blood, you know, some samples from the freezer. It's an interventional study, and I don't quite know how much that would cost in the US. We didn't get it costed, but it's an awful lot more than the EUR 8 million I think the French government's spending on it to do it, say, in the US.

Speaker #5: This is not a university exercise or someone doing some, you know, some samples from the freezer. It's an interventional study.

Speaker #5: And I don't quite know how much that would cost. In the U.S. We didn't get accosted, but it's an awful lot more than the $8 million.

Speaker #5: I think the French government's spending on it, to do it, say in the US. So, huge amount of very valuable work being done for us.

Cameron Reynolds: Huge amount of very valuable work being done for us, and it shows a level of confidence in what we do, and it's very heartening for us as a team to have it being used on actual saving people's lives this year.

Speaker #5: And it shows a level of confidence in what we do. And it's very heartening for us as a team to have it being used on actually saving people's lives this year.

Steven Ralston: Thank you.

Cameron Reynolds: Thank you.

Speaker #8: Thank you .

Speaker #9: Thank you

Operator: Our next question is from Bruce Jackson with The Benchmark Company. Please proceed.

Speaker #1: Our next question is from Bruce Jackson with The Benchmark Company. Please proceed.

Bruce Jackson: Hi. Thanks for taking my questions. I wanted to follow up on the Capture-Seq paper. It's a fabulous study. I'm curious to know how amenable is this process to front-end automation in the lab, and how easily could it be integrated into like an MRD test or a liquid biopsy test in the lab?

Speaker #6: Hi .

Speaker #10: Thanks for taking my questions . I wanted to follow up on the capture paper . The the it's a it's a fabulous study .

Speaker #10: I'm curious to know how amenable this process is to front-end automation in the lab, and how easily it could be integrated into an MRD test or a liquid biopsy test in the lab.

Cameron Reynolds: Jake is here, our chief scientist, so that's probably a Jake question. Jake.

Speaker #5: Jake is here . Our chief scientist . So that's probably a Jake question . Jake . Hello , Bruce .

Jacob Micallef: Hello, Bruce. Thanks for the question. Very good question. Essentially, well, first of all, the updated revised version of the manuscript is live on Research Square now, so that's public, and exactly how it works and how we've proved that we really have produced pure tumor DNA, all of that's in the paper and publicly accessible to everybody. In terms of the question, the basic process involves two parts. The first part is a magnetic antibody, so it's the same as an immunoassay. It's the same as a nuclear immunoassay. It's the same as a PSA assay or a CEA assay. The second part is sequencing.

Jake Micallef: Hello, Bruce. Thanks for the question. Very good question. Essentially, well, first of all, the updated revised version of the manuscript is live on Research Square now, so that's public, and exactly how it works and how we've proved that we really have produced pure tumor DNA, all of that's in the paper and publicly accessible to everybody.

Speaker #4: Thanks for the question . Yeah . Very good , very good question Essentially . Well , first of all , the the updated revised version of the manuscript is live on Research now .

Speaker #4: So that's public and exactly how it works and how we've proved that we really have produced pure tumor DNA . All of that's in the paper and publicly accessible to everybody in terms of the question , the the basic process involves two parts .

Jake Micallef: In terms of the question, the basic process involves two parts. The first part is a magnetic antibody, so it's the same as an immunoassay. It's the same as a nuclear immunoassay. It's the same as a PSA assay or a CEA assay. The second part is sequencing.

Speaker #4: So the first part is a magnetic antibody. So it's the same as an immunoassay. It's the same as a NUC immunoassay.

Speaker #4: It's the same as a PSA assay or a C e And the second part is sequencing . So , you know , immunoassay is easy to automate .

Jacob Micallef: You know, all immunoassay is easy to automate, and the sequencing is actually much less involved than the sequencing that is involved in other tests because we've removed all the background. There's actually less DNA to sequence, and of course, in the end, there's less analysis because most of the analysis is involved in trying to work out whether any of the DNA came from a cancer or not. But if you've removed everything that didn't come from a DNA, that analysis also becomes like a PSA test. You know, it shouldn't be there. If it is there, it came from the cancer. I think it's at the moment what we do is manual, but it is extremely suitable to be automated.

Jake Micallef: You know, all immunoassay is easy to automate, and the sequencing is actually much less involved than the sequencing that is involved in other tests because we've removed all the background. There's actually less DNA to sequence, and of course, in the end, there's less analysis because most of the analysis is involved in trying to work out whether any of the DNA came from a cancer or not.

Speaker #4: And the sequencing is actually much less involved than the sequencing that is involved in other tests, because we've removed all the background.

Speaker #4: So there's , there's actually less DNA to sequence . And of course , there's in the end , there's less analysis because most of the analysis is involved in trying to work out whether any of the DNA came from a cancer or not .

Jake Micallef: But if you've removed everything that didn't come from a DNA, that analysis also becomes like a PSA test. You know, it shouldn't be there. If it is there, it came from the cancer. I think it's at the moment what we do is manual, but it is extremely suitable to be automated.

Speaker #4: But if you've removed everything that didn't come from a DNA, that analysis also becomes like a PSA test. It shouldn't be there.

Speaker #4: If it is there , it came from the cancer . So I think it's it's at the moment , what we do is manual , but it is extremely suitable to be automated .

Cameron Reynolds: Just some indications of cost, Bruce. People asked us this. It's we can answer that in a couple of ways. The capture side, which, as Jake said, the magnetic beads, the antibody, the immunoassay, at the moment may cost us $100, but that's gonna come down, but not to 10 or 20, but you know, somewhere more like $60, $70, $80, something like that, to do the capture side. Then as Jake said, it depends on the sequencing. Now, the sequencing really depends on what the panel looks like, how many markers you have. But you know, that could be a few hundred dollars or $500, depending on where we end up and how the panel looks. But that's sort of the cost you're looking at for the test.

Speaker #5: And just some indications of cost . Bruce . And people ask us this , it's we can answer that in a couple of ways .

Speaker #5: So, the capture side, which as Jake said, involves the magnetic beads, the antibody, the immunoassay—at the moment, may cost us $100, but that's going to come down.

Speaker #5: But not to 10 or 20 . But you know , somewhere more like 60 , 70 , $80 , something like that to do the capture side .

Cameron Reynolds: Then as Jake said, it depends on the sequencing. Now, the sequencing really depends on what the panel looks like, how many markers you have. But you know, that could be a few hundred dollars or $500, depending on where we end up and how the panel looks. But that's sort of the cost you're looking at for the test.

Speaker #5: Then as Jake said , it depends on the sequencing . Now , the sequencing really depends on what the panel looks like , how many markers you have , but you know , that could be a few hundred dollars or $500 , depending on where we end up and how the panel looks .

Speaker #5: But that's sort of the cost you're looking at for the test , the sort of $80 if for the capture , and then the sequencing if it's shallow sequencing or Oxford Nanopore sequencing and a shallow sequencing , it won't be a lot .

Cameron Reynolds: The sort of $80 is for the capture and then the sequencing. If it's shallow sequencing or oxidizable sequencing, it won't be a lot, but that's really to be determined. That's actually something our partners are looking at when we're looking at licensing. Obviously, they're the sequencing experts. It's not a low cost test in the sense of ELISA that costs us $1 or $2 to make. It has a strong potential to be tissue-specific and very accurate. I think the market certainly would bear a few hundred dollars for that test, as we talked about, but that's all in process. It's incredibly encouraging, and an amazing breakthrough for a small company to have managed to concentrate.

Speaker #5: But that that's really to be determined . actually something our partners are looking at when we're looking at licensing . Obviously , they're the sequencing experts , but so it's not a low cost test .

Speaker #5: And the sense of ELISA that costs us a dollar or two to make. But it has a strong potential to be tissue-specific and very accurate.

Speaker #5: So, I think the market certainly would bear a few hundred dollars for that test, as we talked about. But that's all in process.

Cameron Reynolds: I think the market certainly would bear a few hundred dollars for that test, as we talked about, but that's all in process. It's incredibly encouraging, and an amazing breakthrough for a small company to have managed to concentrate.

Speaker #5: But no, it's incredibly encouraging and an amazing breakthrough for a small company to have managed to concentrate. And people say, how did we do it?

Cameron Reynolds: People say, "How did we do it?" What made us able to do it? We're the experts of chromatin fragments, CTCF fragments. Everyone's ignored the ultrashort DNA for a whole lot of reasons. The sequencing machines don't tend to do much below 100. We're experts at nucleosomes, and now we're experts at transcription factor bound DNA. We've really done something. Fifteen years of heartache and pain getting where we are has made us very good at chromatin fragments, and this is just another chromatin fragment. It is actually quite easy process. It's a magnetic bead, an antibody, and sequencing.

Speaker #5: What what made us able to do it ? We're the experts at chromatin fragments , ctcf fragments . Everyone's ignored the ultra short DNA for a whole lot of reasons .

Speaker #5: The sequencing machines don't tend to do much below 100, and we're experts at nucleosomes. And now we're experts at transcription factor-bound DNA.

Cameron Reynolds: We've really done something. Fifteen years of heartache and pain getting where we are has made us very good at chromatin fragments, and this is just another chromatin fragment. It is actually quite easy process. It's a magnetic bead, an antibody, and sequencing. Obviously, there's a lot of secrets in there and a lot of work to get to where we are, but at its heart, it's a very simple process which I think can be optimized a lot from where we are.

Speaker #5: So we've really done something. Fifteen years of hard pain getting where we are has made us very good at chromatin fragments. And this is just another chromatin fragment.

Speaker #5: So, it is actually quite an easy process. It's a magnetic bead and antibody, and sequencing. Obviously, there's a lot of sequence in there and a lot of work to get to where we are.

Cameron Reynolds: Obviously, there's a lot of secrets in there and a lot of work to get to where we are, but at its heart, it's a very simple process which I think can be optimized a lot from where we are.

Speaker #5: But it's hard. It's a very simple process, which I think can be optimized a lot from where we are.

Bruce Jackson: Okay, great. Like just a couple of quick finance questions. What's the anticipated timing of the feline cancer milestone? I know the paper has to be published before you get the milestone, but would that be like a Q2 event, potentially Q3?

Speaker #10: Okay , great . Then just a couple of quick finance questions . The what's the anticipated timing of the the feline cancer milestone ?

Speaker #10: I know the paper has to be published before you get the milestone, but would that be a second quarter event, potentially third quarter?

Speaker #11: So it's difficult to predict . But yeah , we do expect to collect that money this year . We we are in the process of submitting that paper , which is the final step in completing the requirements for the milestone .

Terig Hughes: It's difficult to predict, but we do expect to collect that money this year. We are in the process of submitting that paper, which is the final step in completing the requirements for the milestone. We do expect to have that completed shortly. Then, like I said, it's difficult to know exactly which quarter it's going to fall into in terms of collecting that money. We certainly expect to collect it this year.

Speaker #11: So we do expect to have that completed shortly . And then it's like I said , it's it's difficult to know exactly which quarter it's going to fall into in terms of collecting that money .

Speaker #11: But we'd certainly expect to collect it this year.

Bruce Jackson: Okay. Last question from me on the operating expense profile for 2026. Would you expect that to be up, down, or about the same as 2025?

Speaker #10: Okay . And then last question for me on the the operating expense profile for 2026 , would you expect that to be up , down or about the same as 2025 ?

Terig Hughes: I think we've made a lot of progress over the last 18 months in terms of bringing the cost down. We're now operating at a significantly lower burn rate than we were 18 months ago, for example. Nevertheless, we're continuing with cost-saving actions and, you know, we're targeting to take out another 25% to 30% from the cash OpEx this year. Now, that's not all gonna happen in one fell swoop. That's gonna take us, you know, through the end of the year to achieve that so that the exit run rate is that much lower. I think in terms of quarters, it's a bit lumpy and difficult to predict, but I wouldn't expect a sequential reduction in Q1.

Speaker #11: So, I think we've made a lot of progress over the last 18 months in terms of bringing the costs down. We're now operating at a significantly lower burn rate than we were 18 months ago.

Speaker #11: For example . Nevertheless , we're continuing with cost saving actions . And , you know , we're targeting to take out another 25 to 30% from the cash opex this year .

Terig Hughes: Now, that's not all gonna happen in one fell swoop. That's gonna take us, you know, through the end of the year to achieve that so that the exit run rate is that much lower. I think in terms of quarters, it's a bit lumpy and difficult to predict, but I wouldn't expect a sequential reduction in Q1.

Speaker #11: Now , that's not all going to happen in one fell swoop . That's going to take us , through the end of the year to achieve that so that the the exit run rate is that much lower .

Speaker #11: I think, in terms of quarters, it’s a bit lumpy and difficult to predict, but I wouldn’t expect a sequential reduction in the first quarter.

Terig Hughes: Q1's always a little bit heavier, and there are obviously some severance costs to take into account. I think I would expect, you know, going through the cash OPEX burn rate coming down. Again, yeah, it's not a one big drop. You won't see one big drop. It's gonna continue to come down over the quarters over the rest of the year.

Speaker #11: First quarter is always a little bit heavier . And there are obviously some severance costs to take into account . So I think I would expect , you know , going through the rest of the year to see the cash opex burn rate coming down again , you know , it's not a it's not a , a one .

Speaker #11: You won't see one big drop. It's going to continue to come down over the quarters, over the rest of the year.

Cameron Reynolds: I think, Bruce, something just to say from a more of a take a step back. We are obviously cutting because we understand the climate, and we understand Volition and we need to cut. It's a fundamental shift in the company. We spent a lot of our time and effort on studies, on research, on papers and processes, which we're just not doing anymore to anywhere near the extent that we were because, as you said, the French government is funding the interventional study in sepsis. Mayo Clinic did a lot of that work obviously in the trial and is publishing itself. All those groups Revvity are selling kits to in Europe are, on the whole, paying for the kits. We're not funding those studies.

Speaker #5: And I think , Bruce , something just to say from a more of a take a step back , we are obviously cutting because we understand the climate and we understand dilution and we need to cut , but also it's a fundamental shift in the company .

Speaker #5: We spent a lot of our time and effort on studies, on research, on papers and processes, which we're just not doing any more to anywhere near the extent that we were.

Speaker #5: Because , as you said , the French government is funding the interventional study in sepsis . Mayo Clinic did a lot of that work , obviously , in the trauma and publishing itself .

Cameron Reynolds: Mayo Clinic did a lot of that work obviously in the trial and is publishing itself. All those groups Revvity are selling kits to in Europe are, on the whole, paying for the kits. We're not funding those studies.

Speaker #5: All those groups that are selling kits in Europe are, on the whole, paying for the kits. So we're not funding those studies.

Cameron Reynolds: Overall, it's coming down a lot because we are no longer spending our days doing R&D. We're commercializing. I think we have an absolute pile of products which I think are well being commercialized now. We're shifting the cost base down quite a few notches so that we can, A, extend the runway, but B, it's just a fundamental change in our business. We are not intending to do a lot of research studies anymore. We're firmly in the commercialization path.

Speaker #5: So overall , it's coming down a lot because we are no longer spending our days doing R&D . With commercializing . And I think we have an absolute pile of products , which I think are well beaten into commercialized now .

Speaker #5: So we're shifting the cost base down quite a few notches, so that we can, A, extend the runway, but B, it's just a fundamental change in our business.

Speaker #5: We are not intending to do a lot of research studies anymore. We're firmly on the commercialization path.

Bruce Jackson: Okay. Got it. That's it for me. Thank you for taking my questions.

Speaker #10: Okay. Got it. That's a community. Thank you for taking questions.

Cameron Reynolds: Thanks, Bruce. Take care.

Speaker #5: Thanks, Bruce. Take care.

Operator: We have reached the end of our question and answer session. I would like to turn the conference back over to Cameron for closing remarks.

Speaker #1: We have reached the end of our question-and-answer session. I would like to turn the conference back over to Cameron for closing remarks.

Cameron Reynolds: Thank you everyone for listening. I know it's been a very interesting year for Volition, and obviously we've made a tremendous amount of progress. It's been a tough year in a lot of ways, as you can probably all tell, but I think we've made very strong progress in a lot of areas, and I can assure you we're absolutely focused on getting our products commercialized now. Hopefully we'll have a lot of news on that through the rest of this year, and we can really turn the corner on the commercial side to be a strong commercial company where we've been a very strong R&D and IP company. Keep a close eye out. We should have a lot of news throughout the year. Thanks again for calling in. Bye.

Speaker #5: Thank you, everyone, for listening. I know it's been a very interesting year for Volition, and obviously we've made a tremendous amount of progress.

Speaker #5: It's been a tough year in a lot of ways, as you can probably all tell, but something where we, I think, we've made very strong progress in a lot of areas.

Speaker #5: And I can assure you we're absolutely focused on getting our products commercialized. Now, so hopefully we'll have a lot of news on that through the rest of this year.

Cameron Reynolds: Hopefully we'll have a lot of news on that through the rest of this year, and we can really turn the corner on the commercial side to be a strong commercial company where we've been a very strong R&D and IP company. Keep a close eye out. We should have a lot of news throughout the year. Thanks again for calling in. Bye.

Speaker #5: And we can really turn the corner on the commercial side to be a strong commercial company, where we've been a very strong R&D and IP company.

Speaker #5: So, keep a close eye out. We should have a lot of news throughout the year. Thanks again for calling in. Bye.

Operator: Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.

Speaker #1: Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.

Cameron Reynolds: Thank you.

Bruce Jackson: Thank you.

Louise Batchelor: Thank you.

Q4 2025 VolitionRx Ltd Earnings Call

Request DemoDemo

Volition

Earnings