VolitionRx (VNRX) Q3 2026 Earnings Call Transcript

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DATE

Fri, Nov. 13, 2026

CALL PARTICIPANTS

• Corporate Secretary - Rodney Rootsaert
• Group Chief Executive Officer - Cameron Reynolds
• Group Chief Financial Officer - Terig Hughes

TAKEAWAYS

• Revenue -- $1.6 million for the third quarter, representing a 157% increase compared to $0.6 million in the prior-year period due to accelerated recognition of deferred revenue.
• Operating Loss -- $3.3 million, narrowing by 35% year over year as a result of increased revenue and lower operating costs.
• Operating Expenses -- $4.9 million, a 14% reduction year over year reflecting savings from a company-wide cost-reduction program.
• Headcount -- 28% reduction compared to the same point in 2025, following decisive actions to lower the company's cost base.
• Debt Reduction -- $5.0 million in convertible note debt paid down since June 30, 2026, including the full extinguishment of a $7.5 million note.
• Remaining Debt -- $0.7 million in outstanding convertible notes, following a partial prepayment of $1.7 million on a $2.4 million note in Oct. 2026.
• Cash Position -- $2.4 million as of Sept. 30, 2026, compared to $1.1 million at the end of 2025.
• ATM Facility Proceeds -- $5.2 million in net proceeds received during the third quarter through an at-the-market facility.
• Operating Cash Burn Target -- Under $1.0 million per month by 2027, with management planning to use non-dilutive means such as licensing income and grants.
• Executive Compensation -- 50% reduction in base salary for the CEO and the board of directors until a substantial licensing deal is executed.
• Human Multi-Cancer Early Detection TAM -- $23.0 billion on an annualized basis, representing a significant commercial opportunity for the Capture-Seq technology.
• Minimal Residual Disease TAM -- $13.0 billion for human liquid biopsy applications, which the company is targeting through active licensing discussions.
• Feline Assay Accuracy -- 97% specificity and 86% detection rate for feline lymphomas, as reported in a clinical manuscript submitted for peer review.
• Contractual Milestone Payment -- $5.0 million, which the company expects to unlock upon the peer-reviewed publication of the feline study.
• Sepsis Global Burden -- 166.0 million cases worldwide annually, with all-cause sepsis-related deaths representing 31.5% of total global deaths in 2021.
• Trauma Study Metrics -- 359.7 nanograms per milliliter average H3.1 levels in trauma patients compared to 22.3 in healthy subjects.
• DETECSEPS Funding -- EUR 6.5 million in cash provided by the French government for a sepsis early detection program.
• Net Loss -- $3.8 million for the third quarter, which included $0.4 million in non-cash accounting charges related to convertible notes.
• Year-to-Date Revenue -- $3.0 million through Sept. 30, 2026, reflecting a 134% increase over the $1.3 million reported in the first nine months of the prior year.

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RISKS

• Hughes stated, "revenues remain fairly uneven and difficult to predict from one quarter to the next," noting that early-stage commercialization leads to lumpy quarterly results.

SUMMARY

VolitionRx Limited (NYSEMKT:VNRX) reported third quarter results highlighting a substantial deleveraging of its balance sheet and a narrowing operating loss. Management stated that the company extinguished a $7.5 million convertible note and implemented cost-reduction measures, including a 28% reduction in headcount. The company indicated that its commercial strategy is focused on licensing its Nu.Q epigenetic platform to large diagnostic firms to leverage their existing laboratory infrastructure. Management reported that licensing negotiations are ongoing with more than 12 global diagnostic and liquid biopsy companies across its cancer, NETs, and veterinary product pillars.

• Reynolds noted that the DETECSEPS program in France is an interventional study where "real-life decisions will be made during the study" using Nu.Q NETs as the sole biomarker for early sepsis detection.
• The company indicated that its lateral flow prototype assay can detect nucleosomes in capillary blood from a finger prick, which aims to enable point-of-care triaging in resource-constrained environments.
• Management reported that the initial focus for the Missionpharma collaboration will be neonatal sepsis, which is the leading cause of child mortality in developing nations.
• Reynolds indicated that the French reimbursement submission for Nu.Q Lung Cancer is expected to occur in the current quarter, with a reimbursement process typically lasting up to six months.
• The company reported that it successfully transferred its Nu.Q NETs assay onto the Sysmex Corporation platform and expects to begin the commercialization phase in the first quarter of 2027.
• Hughes stated that the company's objective is "to partially finance our capital needs through non-dilutive means with a combination of revenues, licensing income, and government grants and loans."
• Management noted that peer-reviewed clinical data published in August showed Nu.Q NETs H3.1 to be an independent predictor of 28-day mortality in sepsis patients.

INDUSTRY GLOSSARY

• Nu.Q: A proprietary platform developed by Volition that uses blood tests to detect and monitor diseases by analyzing nucleosomes in the blood.
• NETosis: A process where neutrophils release extracellular traps (NETs) to trap and kill pathogens; overactivation is associated with sepsis and other inflammatory diseases.
• Capture-Seq: A technology that isolates and captures circulating tumor-derived DNA from plasma samples to enhance cancer detection and monitoring.
• MCED: Multi-Cancer Early Detection; a type of test designed to detect multiple types of cancer from a single blood sample.
• MRD: Minimal Residual Disease; the small number of cancer cells that remain in the body after treatment, used to monitor recurrence risk.
• H3.1 Assay: A specific test within the Nu.Q platform that measures histone H3.1 variants to distinguish between sepsis and non-infectious inflammation.

Full Conference Call Transcript

Operator: Hello, everyone, and thank you for standing by. Welcome to VolitionRx Limited's third quarter 2026 earnings conference call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be open for questions. 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. If you're using speaker equipment, please lift the handset before making your selections. This conference is being recorded today, November 13th, 2026. I would now like to turn the conference over to Rodney Rootsaert, Corporate Secretary. Please go ahead.

Rodney Rootsaert: 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 on information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties, and assumptions.

Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance, or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any of these forward-looking statements made during the course of this call.

Cameron Reynolds, Group Chief Executive Officer, will open the call, providing a summary of recent key achievements, and will then hand over to Terig Hughes, Group Chief Financial Officer, to give a financial report before returning back to Cameron, who will discuss upcoming milestones. We will then open the conference call to a question-and-answer session. And with that, I'll turn the call over to Cameron.

Cameron Reynolds: Thanks, Rodney, and thank you, everyone, for joining Volition's earnings call today. As always, we very much appreciate your time given the busy earnings season. I'll begin just by saying I have a croaky throat today, so I will take it nice and slow, and I apologize for my voice. It has been a very full past quarter as we have continued to execute our plan to commercialize our game-changing Nu.Q platform. This has involved work on a wide range of commercialization efforts focused on licensing our products and technology worldwide. At the same time, we have taken decisive action to strengthen our financial profile by both cutting costs and significantly reducing debt, which our CFO, Terig, will outline later.

We have made strong progress across our key product pillars this year, evidencing clinical utility in a very wide range of uses and driving commercialization. Taking each in turn, starting with Nu.Q NETs. At the start of the last quarter, we issued a comprehensive update video and PDF showcasing the significant scientific and clinical evidence we have amassed relating to our Nu.Q NETs products and listing the extensive base of data now published. Results consistently showed that our Nu.Q NETs H3.1 assay accurately distinguishes sepsis from non-infectious systemic inflammation, is highly correlated with disease severity, and provides excellent prognostic utility for outcomes such as organ failure and mortality.

Professor Djillali Annane, one of the world's leading experts in sepsis, believes Nu.Q NETs could be a game-changer in modifying a patient's trajectory and that introducing Nu.Q NETs into hospitals could lead to new ways of treating sepsis, improving patient survival, and the quality of life of survivors. He believes NETs themselves will become a separate treatable trait. This is a very powerful testament from a top KOL who strongly believes our test will be commonly used in routine use. Routine use will be the key. We are well progressed in getting our test used in routine use in Europe and hope to have an update in the current quarter.

Having clinicians routinely using our test in sepsis will be a defining moment for Volition in our long journey. Excitingly for Nu.Q NETs, we have also made incredible progress in the development and evaluation of our lateral flow prototype assay. The journey to our lateral flow test started a little over one year ago in July 2025, when we announced the quantification of nucleosomes in whole venous blood using our lateral flow prototype assay. In April of this year, we reported the technical breakthrough of being able to detect nucleosomes in capillary blood or finger prick blood.

We announced that we have demonstrated correlation of the lateral flow prototype assay and our established CE-marked automated Nu.Q NETs assay in samples of critically ill confirmed sepsis patients in the intensive care unit. The ability to rapidly identify high-risk patients at the point of care by quantifying their nucleosome levels using a finger prick sample and simple lateral flow device aims to enable quicker clinical decision-making and consequently better patient outcomes. This prototype technology has the exciting potential to strengthen our product portfolio. With recent estimates indicating approximately 166 million cases of sepsis worldwide, the addressable market is huge. All-cause sepsis-related deaths in 2021 represented 31.5% of total global deaths, with the highest burden of mortality in lower-middle-income countries.

This lateral flow test is a potential game-changer, not only in diseases where time is critical, such as sepsis, but also in significantly expanding potential use cases beyond traditional hospital infrastructure. It also creates a compelling pathway into underserved lower-middle-income countries where lab infrastructure may be weak or nonexistent. Last month, we announced another very important step with the LOI with Missionpharma. Missionpharma, based in Denmark and part of the Toyota Tsusho Group, is a leading global supplier of healthcare products and innovative solutions, impacting the lives of over 100 million patients annually. By expanding beyond centralized lab testing, this finger prick sample test could be used worldwide, beyond solely high-income countries.

With the help of Missionpharma, we aim to accelerate commercialization and market access, particularly in resource-constrained countries and humanitarian emergency settings. Missionpharma has strong partnerships with a broad institutional base, including with United Nations, the UN, agencies specialized in global health and humanitarian response. Following on from discussions with key global health institutions, it is clear that Volition's clinical intended use should initially focus on one well-defined use to start. That is developing and validating a tool for triaging and prognostication for neonatal sepsis, that is sepsis in newborns and young infants.

Missionpharma has seen a very strong interest from partners in this intended use and customers in Volition's innovative diagnostic solutions, particularly in low and middle-income countries and humanitarian emergency settings. They are looking forward to collaborating with Volition, with the aim of saving millions of children's lives annually. They also believe Nu.Q NETs lateral flow test prototype is a potential game-changer, and they are delighted that Volition and Missionpharma have now established a basis for collaboration, with initial focus on evaluating the lateral flow prototype with a well-defined and impactful clinical utility, as above, sepsis in newborns and young infants.

Outside of sepsis, but still with Nu.Q NETs and diseases associated with Nu.Q NETs, we are working with Sysmex Corporation, a multi-billion dollar company listed on the Tokyo Stock Exchange. Sysmex is a global leader in the field of in vitro diagnostics for hemostasis and thrombosis, among other diseases, where neutrophil extracellular traps, NETs, play such an important role. We have already successfully transferred our Nu.Q NETs assay onto Sysmex's platform and are delighted they have commenced the optimization phase in diseases associated with NETosis. We aim to go to the next step and beginning commercialization phase with them in Q1 of next year.

The collaboration is in addition to that announced last year with Werfen's Immunoassay Technology Center, a worldwide leader in specialized diagnostics. That agreement concerned another NETs-related disease, antiphospholipid syndrome, APS, and they too are making good progress. We believe that Volition's Nu.Q NETs test could provide not only improved diagnostic information to aid clinical decision-making and personalized care, but could also be a low-cost test to continue to monitor a patient's condition in many NETs-related diseases. Next up, Nu.Q Cancer, specifically Nu.Q Lung Cancer. Lung cancer is the major cause of cancer-related mortality worldwide. 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.

We have made strong progress towards our initial French reimbursement submission for Nu.Q Lung Cancer, supported by our long-term collaborators at the Hospices Civils de Lyon, one of Europe's leading cancer centers. French reimbursement approval 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 tests to help save lives and improve outcomes. French reimbursement approval will be a major milestone for Volition in the commercialization and licensing of Nu.Q in the human cancer field, and once achieved, we anticipate introduction into routine clinical use in France, and will then set our sights on rolling out to other countries.

Staying with cancer, but moving on to Nu.Q Capture-Seq technology. Our clinical paper detailing this technology has been peer-reviewed and published. Volition is, we believe, the first liquid biopsy company to focus on circulating cell-free nucleoproteins, and we have filed a number of new patents to protect this technology. Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our strategy in the vet market, and we anticipate diverse deal structures with potential for upfront and milestone payments and future recurring revenue. We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development of our Nu.Q Capture-Seq technology.

We believe the potential use cases for Nu.Q Capture-Seq represent a significant commercial opportunity, with a total addressable market on an annualized basis of approximately $23 billion for the human multi-cancer early detection, MCED, use, and over $13 billion for minimal residual disease use, MRD. From a Nu.Q Vet perspective, we made solid progress with our research into the use of Nu.Q in cats, most notably our submission for peer review of our clinical manuscript in May. This paper reports the high accuracy of our Nu.Q Vet feline prototype assay in detecting lymphoma in cats, the most common cancer in the species. At 97% specificity, the assay detected 86% of feline lymphomas.

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 vet medicine. This opens up the potential for cancer screening and monitoring in cats. There are more than 60 million pet cats in the U.S. alone, 25% of which are senior cats, and therefore suitable for an annual check. This represents a tremendous commercial opportunity for Volition. The publication of the study in a peer-reviewed journal is expected to subsequently unlock a $5 million contractual milestone payment, and 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, given it was only in May of last year that we reported detecting nucleosomes in cats, a third species for Nu.Q. With that, I'll pass over to Terig for our financial report.

Terig Hughes: Thanks very much, Cameron, and hello, everyone. I am pleased to provide a financial report for the third quarter ended September 30th, 2026. As Cameron mentioned earlier, while our focus is now firmly on commercialization and progressing licensing negotiations, we have also continued to strengthen our financial profile through a combination of cost cuts and debt reduction. In September, we announced that we had completed the repayment and extinguishment of a $7.5 million convertible note, and subsequent to quarter end, in October, we announced a partial prepayment of the remaining $2.4 million note, leaving a balance of just $0.7 million.

As of today, we have paid down over $5 million of convertible note debt since June 30th, substantially deleveraging the balance sheet. We also continue to take actions to cut costs and reduce cash burn, which included further headcount reductions, the CEO taking a 50% salary cut until a substantial deal is signed, and the board and Chairman reducing their cash fees by at least 50%. Some of the actions taken to date will take time to fully reflect in the financial results.

Our goal is to bring our operating costs and cash burn below $1 million a month in 2027, and to partially finance our capital needs through non-dilutive means with a combination of revenues, licensing income, and government grants and loans. Now to the reported P&L for the quarter. We reported revenue of approximately $1.6 million in the third quarter, compared to approximately $0.6 million in the same period of 2025. This result reflected higher Nu.Q Vet revenues, the result of accelerated deferred revenue recognition, and was partly offset by lower revenue from Nu.Q® Discover, reflecting the timing and uneven nature of project delivery.

For the year-to-date through September 30th, total revenue was $3 million in 2026, compared to $1.3 million in the prior year-to-date, and year-on-year growth was 134%. As we have stated previously, at this early stage of commercialization, revenues remain fairly uneven and difficult to predict from one quarter to the next. While we 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, total operating expenses for the quarter were $4.9 million, compared to $5.7 million in the same period last year, a 14% reduction year on year.

This reflected savings from our cost reduction program, including a 28% reduction in headcounts compared to the same point in 2025. Since the quarter end, we have and will continue to take measures to reduce costs further in 2026 and 2027. Operating loss for Q3 narrowed for the second consecutive quarter to $3.3 million, which compared to $5.1 million for the same quarter last year, an improvement of 35%. This improvement reflected revenues up approximately $1 million and operating costs down approximately $0.8 million. Net loss for the quarter was $3.8 million, compared to $5.4 million in the same quarter of 2025, and included non-cash accounting charges of net $0.4 million related to the convertible notes.

Net cash used in operating activities declined for the third consecutive quarter to $4.6 million. This compared with $3.6 million in Q3 of 2025, which was lower, mainly reflecting the timing of supplier payments in the prior period. Cash and cash equivalents at the end of the quarter totaled approximately $2.4 million, compared to $1.1 million as at December 31st, 2025. Receipts in the third quarter of 2026 included approximately $5.2 million in net proceeds from our at-the-market or ATM facility. To summarize the finance report, third quarter revenue was $1.6 million, up 157% year-on-year, and year-to-date revenue was $3 million, up 134% year-on-year for the nine-month period to September 30th reflecting the acceleration of deferred revenue recognition.

Operating expenses for the third quarter were 14% lower year-on-year, and operating loss was 35% lower year-on-year for the third quarter. Repayment of a $7.5 million convertible note was completed in the quarter, significantly deleveraging the balance sheet. Further cost actions were taken with the goal to reduce operating cash burn to under $1 million a month in 2027. A lot of progress in the quarter financially. I will now pass over to Cameron for a look at what's to come in the coming quarters. Cameron?

Cameron Reynolds: Thanks, Terig. Looking ahead, we have a lot of exciting milestones. Starting with Nu.Q Vet, in addition to the anticipated publication of the feline paper, we also anticipate further development work of the assay as we prepare to commercialize the use of Nu.Q in cats. From a Capture-Seq point of view, we are in active discussions with a range of large companies with a view to license this technology to turbocharge product development and launches worldwide. For Nu.Q Lung Cancer, our key priority is to gain reimbursement status for the product in France. Regarding Nu.Q NETs, our recent momentum has really picked up.

Working with Professor Djillali Annane and team, we look forward to not only finishing the 1,000+ patient RHU RECORDS study, but also starting the DETECSEPS program, with the first recruitment expected soon. As a reminder, DETECSEPS is a French government-sponsored real-world evaluation of early detection of sepsis, and Volition's Nu.Q NETs is the sole biomarker. The DETECSEPS program provides an opportunity to receive individualized and personalized care adjusted to the risk of deterioration and progression to sepsis. It is a privilege to be involved in such a program.

We hope that through the earlier identification of sepsis, lives can be saved, the quality of life of survivors can be improved, and importantly, that the burden on the healthcare system can be reduced. We are also moving forward with the Mayo Clinic and expect further progress to be announced soon. You may recall the publication of a study at the Mayo Clinic in the Shock Journal earlier this year. This was a sizable study with the Mayo Clinic of 674 trauma patients.

It demonstrated that nucleosome levels, as measured by our Nu.Q H3.1 assay and Nu.Q H3R8Cit assay, are elevated in people who have experienced a traumatic event, and even higher in those patients that go on to have complications from the trauma. The numbers are quite stark, and some of the most compelling data we have ever seen. H3.1 levels in healthy people were about 22.3 nanograms per mil. Those with trauma were 359.7, and those that went on to get venous thromboembolism, VTE, were 828.4 on average, over 37 times the level in healthies. This is very important information for the clinician.

The identification of reliable biomarkers in trauma patients is a clinical challenge and remains an unmet need in the emergency and surgical settings. Dr. Park from the Mayo Clinic has previously commented, "These biomarkers could aid in early risk identification and may inform targeted preventative strategies in trauma care." For my part, I believe this is a significant study with clear data, not only for clinicians, patients, and their families, but also for Volition. A peer-reviewed publication with the Mayo Clinic research team can only support our efforts to commercialize our Nu.Q NETs product.

In drawing to a close, we have developed a truly remarkable, versatile platform and are working with governments, international organizations, leading hospitals in a wide range of countries, key opinion leaders, and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide. We set out 16 years ago 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 pending in both early sepsis detection and lung cancer management, and commercialization moving steadily forward, 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, as well as governments and international organizations worldwide. Combining our groundbreaking technology with their installed base of labs, analyzer machines, and sales forces around the world will achieve the optimal outcome for us. Large companies have the resources to realize these opportunities better than Volition. The TAMs, total addressable markets, for our technologies on an annualized basis are multi-billion dollar opportunities, not only for Volition, but for our licensing partners too.

Volition continues to make strong progress, both clinically and commercially. We are very active with a range of potential partners and are continuing our discussions with more than a dozen of the world's leading diagnostic and liquid biopsy companies to license and commercialize our very broad IP product portfolio. As discussed before, these discussions are at various stages of the negotiation process across all of our pillars. Our laser focus is on executing licensing agreements, and I will update you as our discussions progress. I have now taken personal direct control of 11 of the most important commercial relationships, do everything we can to push them across the line.

To show my personal commitment to getting through this critical and exciting phase, I have cut my own salary by 50% until this is achieved. We are laser-focused as a team on commercializing our remarkable platform. Thank you for joining the call today. 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 Michael Okunewitch with Maxim Group. Please proceed.

Michael Okunewitch: Guys. Good morning. Congrats on all the progress, and thank you for taking my questions today.

Cameron Reynolds: Good morning.

Michael Okunewitch: I guess first off, I just wanted to ask a little bit about the DETECSEPS study, and in particular, how you plan to apply that data. Is this going to be limited to France? Could it support some international efforts? Is it going to be kind of a pilot to inform later studies? How do you plan to use the DETECSEPS data?

Cameron Reynolds: This is the French government who paid a lot of money. If we were to do this ourselves, it would be tens of millions of dollars. They put in like EUR 6.5 million of cash and the rest in kind. Adding our test to the current test, which is NEWS2, which is not a biomarker but a mix of physical symptoms. If it does go well, this is the French government testing it for the French government to launch this as the screening test in France. It is a CE-marked product already. We have IVDD on the IDS-i10 from Revvity, and obviously we are moving to IVDR, which we have announced we aim to finish the application this year.

The aim is to roll out in France, which would be obviously a very large number of tests in itself, but that would be the basis for a whole European rollout. The key opinion leaders in France, the French government, and Dr. Djillali Annane are very much in this field, and we are not aware of any other solutions which really work the way ours does. We are very hopeful that this will be successful and this will lead to a rollout in the rest of Europe. We would like to thank the French government for their vision in funding all of this.

As you know, the cost of the trial is considerably more than our current market capitalization, and that was all funded by the French government. Very encouraging, and the aim would be to roll out all through Europe, which would be a huge number of tests annually based on this as a study.

Michael Okunewitch: Thank you. Just looking a bit more broadly when thinking about NETs, given the low cost of Nu.Q tests, how important is the international component of this beyond the major markets like Europe, the U.S., and Japan? Do resource-constrained regions play a larger role in the overall opportunity given its potential to act as a low-cost screening tool for triage at common hospital visits?

Cameron Reynolds: Good question. Obviously, the U.S. and Europe are both huge markets. If it becomes something like CRP, that's hundreds of millions of tests per year as a potential market. The rest of the world is a very sizable market. I think it probably could be equivalent in the number of tests, but I think the value is always going to be biggest in Japan, Europe, and the U.S. That's not to say, obviously, we've got an LOI with Missionpharma A/S, very large, very serious company that specialize in working with companies to launch in resource-constrained zones, also emergency areas. So, that's potentially a very similar number of tests, but a lower value, but still huge.

I mean, what the aim of someone like Missionpharma A/S is to make the test very low cost, very affordable, get the UN agencies to buy it for general use, and also emergency settings. The really big thing we have is how useful NETs are in so many different areas. That, in the first instance, often is a challenge because it's useful in COVID, in sepsis, probably Ebola, a whole lot of areas. So we worked with Missionpharma A/S and the UN agencies to work out a very good thing to start with, a discrete market, because it's such a huge different there are lots of uses for it. What they came up with was neonatal sepsis.

So that's brand newly born children and their mothers, and that is the biggest killer of children in the developing world. So obviously, a huge, huge market. The lateral flow test will be an absolute life-changing game changer. So, I think potentially a very, very big market, but I think always the European and the U.S. markets will be bigger in dollar value, though the other countries could be bigger in number of tests, but- -I don't think there's any issues for the company in having large addressable markets in everything we look at. Did that make sense?

Michael Okunewitch: Yeah, no, it was very helpful. Last off, I wanted to see if you could talk a little bit about Capture-Seq and what the impact of the Galleri AdCom could be on that, particularly with the split to positive recommendation, the potential for a multi-cancer test to be approved, but without that early label.

Cameron Reynolds: Yeah, it's very big because obviously early stage is the biggest for everything. All of our data so far, where we've done cancer and healthy, was exceptionally good in early stage. So, we think that's something that's possible with the Capture platform. However, it's obviously the easier it is to get regulatory approval. You never know in the final studies where you'll end up with everything. So every step forward is helpful to us. But we're very confident in the whole oncology portfolio. The Capture side, where we're developing obviously and talking to a range of companies on how to commercialize. I'm not sure if you've been following the H3K27. That's in reimbursement in France now, process.

We expect to have some news on that later this year as well. We're also working with the Japanese government, the SCRUM program in Taiwan. Our whole human oncology section is also moving forward very well.

Michael Okunewitch: All right. Thank you very much for taking my questions.

Cameron Reynolds: Thanks, Mike. Take care.

Operator: Our next question is from Justin Walsh with JonesTrading. Please proceed.

Justin Walsh: Hi, thanks for taking the question. It would be great to hear what geographies you are considering targeting for Nu.Q Cancer following your potential reimbursement and routine use in France.

Cameron Reynolds: Yeah. We have obviously spoken to the authorities there. They see themselves as the leaders in the cutting edge, certainly in Europe. If you look up Dr. Djillali Annane, I do not think it is too much to say he is a bit of a legend in the space. So I think the rest of Europe would be following. We have obviously looked at the big countries like Germany, Italy, Spain, the low countries. Britain is a little It is one of our home countries, but it is a little more difficult at the moment for a whole lot of obvious reasons. But the faith and the action by the French government has been absolutely awe-inspiring for us.

They have spent a huge amount of money finishing off this study. It will be a completely definitive study of around 1,000 people. As long as the data continues to be good, and certainly everything we have seen from everything, it should be. They are obviously confident. It is an interventional study, meaning real-life decisions will be made during the study. So obviously, they think there is a good chance it is working. That should be the start of rolling it out throughout the rest of Europe. So obviously, that is not for every sepsis person. That is also for everyone who enters hospital. You are taking Nu.Q levels early on to see.

So it is not just the sepsis patients, but a general screening test it would be ultimately used for. Currently, there are no markers which do what ours does. As we discussed before, Justin, our test will always be low-cost, easy to use on current platforms. The current platform is on the Revvity machine, so obviously another big company. As we have discussed, we are in discussions with large diagnostic companies to launch the NETs test on their large, even more installed base. So yeah, it is progressing very well on all those fronts. There has been a lot of progress.

I am very happy with how NETs are going, both clinically, it is just expanding in its uses tremendously, and we are getting a lot of take-up now from the large companies and governments on helping this launch. If you take Missionpharma in developing countries, if you take the French government, if you take the Mayo Clinic for its uses, obviously Revvity, it is on their machine. We have not disclosed who yet, but we are in discussions with a range of very large diagnostic companies on launching on their platforms. So I think it is all moving in a very, very good direction for Nu.Q NETs.

Justin Walsh: Thanks for taking the question.

Cameron Reynolds: Thank you. Take care, Justin.

Operator: Our next question is from Bruce Jackson with StoneX. Please proceed.

Bruce Jackson: Hi, good morning. Thanks for taking my question. Thank you, Cameron.

Cameron Reynolds: Yeah.

Bruce Jackson: Help us out in terms of the process here. You are going to submit sometime later this year. Then typically, how long does it take for the French authorities to sort through the application and then actually grant the reimbursement?

Cameron Reynolds: That is a good question. It is about a six-month process. They say up to six months from the process. It is not like the U.S. reimbursement in so far as it is the big hospitals, Lyon, and there are some very big ones working on. Those hospitals get to be reimbursed. It is a, quote, unquote, "temporary reimbursement," but it lasts five years, so that is a good start. It allows for them to run very large numbers of samples through those hospitals. It is a much shorter process to get reimbursement approval and allows you to sell through those hospitals, and they are very, very big ones.

The idea being, you gather more and more data and large amount of data for international applications and for permanent reimbursement. This initial reimbursement would last five years, so it is a very good way to start. Yet again, the French system seems to be the most adaptable and helpful, as they have been with DETECSEPS. They are being very, very helpful on the lung cancer side as well. We are very encouraged, and we expect to have a lot more news on that in the next few months. We expect DETECSEPS to have news in the next few months as well, as they collect the first people into the study.

Bruce Jackson: Okay. Speaking of sepsis, right now the studies are being done on a lab-based instrumentation, like the IDS-i10. Do you have the ability to put that onto a lateral flow type of platform?

Cameron Reynolds: For NETosis, you mean, or?

Bruce Jackson: Right now the studies are on the IDS-i10 and the lab instruments.

Cameron Reynolds: For NETs. Yes.

Bruce Jackson: For NETs.

Cameron Reynolds: Yes. For NETs, yeah. For NETs, yes. This has actually been a huge success for us. It is working very well on the lateral flow, which is why Missionpharma A/S and the UN is very interested in develop. Well, sorry, resource-constrained countries. Apparently that is the description. Resource-constrained countries. And they are very interested in neonatal sepsis. It is the biggest killer of children. And as you know, there is always funding for children in developing countries. It is a tragedy when someone that young dies from something so preventable. So the lateral flow works very, very well. They are looking to develop something even cheaper. The one we have developed is more useful in developed countries.

They are looking for just a graphic readout, which can be made a lot cheaper for those uses. So it works on a lateral flow. The current machine in the studies is the Revvity IDS-i10 and IDS-i20, a fantastic machine made by IDS, which is owned by Revvity, the old PerkinElmer. We have announced working on the Sysmex Corporation machine, on the Werfen machine, and we are talking to a range of other large companies with large auto analyzers to go on their machines, because we believe that this test could, should, hopefully will be used by hundreds and hundreds of millions of people per year. And to do that, you cannot just be on one machine.

You need to be on lateral flow and a range of machines so that it can be run routinely every time you have blood work. And we are well on the way. Lateral flow and all the other machines I mentioned, it works great on, reproducibly, robustly. It has taken us a long time to get it worked this well. Now it does, and now we are rolling out on a range of different platforms. We believe that is needed to get to the true potential of such an amazingly versatile test as a NETosis test.

Bruce Jackson: Okay.

Cameron Reynolds: Does that make sense, Bruce?

Bruce Jackson: Yes, absolutely. Last question for me is, with the DETECSEPS study in France, how does that flow through to revenue?

Cameron Reynolds: Ultimately, what this would be, assuming it is successful, and a study is a study, but they are confident it is interventional. They are funding the whole thing, and it is many times our market cap if we were to repeat that study. So they are very confident. That would mean it would become the national screening test in France, and then we strongly suspect no other country has a solution. They would use that data to launch Europe-wide, because it is a CE-marked product already. IVDD, and we are moving to IVDR, as we have discussed. We have done all that work on the Revvity machine. It should, if successful, unlock a very, very large revenue stream in Europe.

I think what it also is unlock, I cannot mention the names because under confidentiality, but you know the big diagnostic companies. We're speaking to a very wide range of them about adapting to their large auto analyzer machines, as well as the Revvity machine. That's when we really start to take off vertically on adoption. A very, very big vote of confidence from the French government, and an extreme question. Obviously, sepsis is the biggest killer of people worldwide, and they're confident enough to be funding the whole study and making it interventional. We're eagerly awaiting all that to be finished.

Bruce Jackson: All right. Great. Thank you very much.

Cameron Reynolds: Thanks. Thanks, Bruce.

Operator: As a reminder, just star one on your telephone keypad if you would like to ask a question. Our next question is from Steven Ralston with Zacks. Please proceed.

Steven Ralston: Good morning, or good afternoon to you.

Cameron Reynolds: Good morning. How are you, Steven?

Steven Ralston: I think I have the same bug you have. Excuse my voice.

Cameron Reynolds: It is going around.

Steven Ralston: Yeah. About 19 months ago, in March of last year, you signed that first human clinical study contract for Nu.Q Discover, and it was related to a 12-18-month phase I-IIB study. Given there wasn't any services revenue in Q2 or Q3, and that's where the line over where it would show up, what is the status of that phase I-IIB study?

Cameron Reynolds: I can't mention exact. I think I know which one you're mentioning. We didn't mention the name because it's confidential. But we have done a lot of work with a range of different companies on Nu.Q NETs and Discover, and also from the cancer side. We've actually had a lot of interest in the last few quarters as well from new companies. The studies tend to finish a phase I or phase II or phase III, and then readjust and then launch the next phase if successful. We can update you if they make it public from what they're doing on the next stage. But there is a lot of interest in Nu.Q® Discover.

What tends to happen is you sign up one stage, you get paid a reasonably good chunk of money, but then it takes them a year or more to finish it, and then they've got to analyze it. But that's why we have a lot of different ones in the pipeline being worked through at the same time. So, there is a lot of interest. It is lumpy. That's why Terig says a lot. It's lumpy during the process. But it's certainly got our name out there as well. And there's actually been a lot of action also on Nu.Q NETs as a treatable trait. Remember, there's different ways of doing it.

We're now working with a very large number of. Well, in every single one of the different groups, on different as being the monitoring test as treating NETs as a treatable trait. We'll have a lot more news on that in the coming months as well. Terig, do you have anything more to say on Discover?

Terig Hughes: No, only to reiterate that we're really at the behest of the schedules of our pharma and biotech partners, and it's very unpredictable. Some of the projects that we thought would materialize in Q1-Q2 got delayed. That's to your point, that's really why we didn't see any service revenue. We have seen good demand for our kits still in the Discover space, but a couple of the big projects got pushed out. Again, there's not a lot we can do about that as that's the start and end dates of these clinical trials is really difficult to predict.

Steven Ralston: Thank you. Also, about a year ago, you had an initial one-year contract co-marketing with Hologic for Nu.Q® Discover and also the APS research license with Werfen. Both of them hit their one-year marks, what, actually two months ago. What is the next step with both those partners? Are you in discussions to convert them to exclusive arrangements with some upfront fees?

Cameron Reynolds: Yes. There's actually three going on at the moment. I'll start with the one which is not probably advanced, which is with Hologic. I don't know if you've heard, but obviously they've had a massive corporate restructuring, including the DiaSorin, the group we dealt with splitting off. But we're still working with them, but no action there. On Werfen, yes, we've been in very close contact with them on APS, and we're doing a lot of following up with them. I'd strongly expect we're going to get to the next phase with them in the short term. They're just finishing off the data now, so we'll see all of that. But Werfen's moving very well.

Sysmex was also, it's been two years, but they've finished their development work, which I mentioned. I'd strongly expect we'll get to a next phase with them in the short term as well. Strong progress with Werfen and Sysmex, and not with Hologic, but I think primarily due to their own internal reorganization issues. You've probably seen that in the press. But, good movement on two of them.

Steven Ralston: All right. Thank you. For my last question, it's a financial one. With the 2025 Lind note being paid off and some repayments made on the 2026 Lind note, the payments being deferred until January of next year, what is the plan for the remaining, as I figure, about $707,000 principal balance going forward in January?

Cameron Reynolds: So, just before Terig answers that, it's been a massive change for us. Obviously, we paid down $5 million or $6 million in the last quarter or two. So, the last $700,000 is quite a small amount considering between the both notes, we're getting close to $10 million. We're very largely well being through all of that. Terig, do you want to answer the specifics?

Terig Hughes: Yeah. So, as you said, the repayments have been deferred until January. Yeah, at that point, we would intend to continue with the repayment. It's not a huge amount of money that's left over. But, yeah, we've done, I think, a really big job in paying that down. We paid off the $7.5 million note, the $2.4 million note, so there's only $0.7 million left. Yeah, we will continue with the scheduled repayment in the new year. But it gives us a bit of breathing space and takes a bit of pressure off the stock.

Steven Ralston: Yes. So your plan is to repay all the notes and have them-

Terig Hughes: Yes.

Steven Ralston: -retired?

Terig Hughes: Yes, absolutely.

Steven Ralston: Okay. Thank you for taking my questions.

Cameron Reynolds: Thank you. Take care.

Operator: This will conclude our question and answer session. I would like to turn the floor back over to Cameron Reynolds for closing remarks.

Cameron Reynolds: Thank you very much for being on the call today. We have had a very busy quarter, obviously strengthening or reducing the debt by a huge margin, also making a lot of progress on commercialization and all the licensing discussions, and also clinically. Thank you for your time, and I look forward to our next call. Have a great day.

Operator: Thank you.

Cameron Reynolds: Thank you.

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

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