VolitionRx LimitedVNRX
Recorded

VolitionRx Limited 2026 Q2 Earnings Call

Review the key takeaways and the transcript of this earnings call.

PeriodQ2 2026Duration49 minParticipants10

Transcript

Preview the first fifteen paragraphs, organized by speaker.

Operator

Welcome to VolitionRX Limited's second quarter 2026 earnings conference call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be open for questions. If you have a question, please press the star key, followed by the number one on your touch tone phone. If you would like to withdraw your question, please press the star key followed by the number two. If you're using speaker equipment, please lift the handset before making your selections. This conference call is being recorded today, August 14th, 2026. I'd now like to turn the conference call over to Louise Batchelor, Group Chief Marketing and Communications Officer.

Speaker

Please go ahead. Welcome everyone to today's earnings conference call for VolitionRX Limited.

Speaker

Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties, and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance, or achievements expressed or implied by these statements.

Speaker

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. Cameron Reynolds, Group Chief Executive Officer, will open the call, providing a summary of key recent achievements, and will then hand over to Terig Hughes, Group Chief Financial Officer, to give a financial report. Before returning to Cameron, who will discuss 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.

Cameron ReynoldsGroup CEO

Thanks, Lou, and thank you everyone for joining Volition's earnings call today. As always, we very much appreciate your time, given the busy earnings season. We have made strong progress across all our product pillars so far in 2026. Taking each in turn, first starting with Nu.Q NETs. Subsequent to quarter end, we issued a comprehensive video update 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 have consistently demonstrated 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. Moreover, Nu.Q NETs provides new and additional information above standard organ failure scores such as APACHE II and SOFA scores.

Cameron ReynoldsGroup CEO

Professor Djillali Annane, one of the world's leading experts in sepsis, has stated that he believes Nu.Q NETs could become a game changer in modifying a patient's trajectory, and that introducing Nu.Q NETs into hospitals would lead to new ways of treating sepsis, improving patient survival, and the quality of life of survivors. A very powerful testament indeed. Excitingly for Nu.Q NETs, we have also made incredible progress in the development and evaluation of our lateral flow prototype assay. A little over a year ago, in July of 2025, we announced the quantification of nucleosomes in whole venous blood using our lateral flow prototype assay. Then, in April of this year, we reported the technical breakthrough of being able to detect nucleosomes in capillary blood or blood from a finger prick.

Cameron ReynoldsGroup CEO

Now fast-forward to earlier this week and our announcement 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 potential addressable market is absolutely huge. All caused sepsis-related deaths in 2021 represented 31.5% of total global deaths, with the highest burden of mortality in lower and middle-income countries.

Cameron ReynoldsGroup CEO

This 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-income countries, where laboratory infrastructure may be weak or nonexistent. By enabling decentralized testing, our total addressable market expands. More on which later when I discuss upcoming milestones. We have made and continue to make incredibly rapid progress in the development and evaluation of this finger prick technology. Outside of sepsis, but still with Nu.Q NETs, and diseases associated with NETosis, we were delighted this quarter to announce our collaboration with Sysmex Corporation, a multibillion-dollar market capitalization company listed on the Tokyo Stock Exchange.

Cameron ReynoldsGroup CEO

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 we are delighted they have commenced the optimization phase in disease associated with NETosis. This collaboration is an addition to that announced last year with Werfen's Immunoassay Technology Center, a worldwide leader in specialized diagnostics. That agreement concerns 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 a major cause of cancer-related mortality worldwide.

Cameron ReynoldsGroup CEO

We believe that 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 in France demonstrated that our Nu.Q Cancer technology empowers clinicians to make more informed treatment decisions, and provides valuable new monitoring capabilities throughout the patient journey. Several manuscripts, conference posters, and presentations have already been published. Subsequent to quarter end, two further papers have been made available on preprint services with a further manuscript due for submission by the NTU team in the coming weeks. This evidence provides the basis of our reimbursement submission, supported by our long-term collaborators at Hospices Civils de Lyon, one of Europe's leading cancer centers.

Cameron ReynoldsGroup CEO

This 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 tests to save lives. This quarter, we participated in our first pre-submission meeting with the authorities and anticipate a follow-up meeting and ultimately a submission by the third quarter of this year. Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q in the human cancer field. Assuming achievement, we anticipate the introduction into routine clinical use in France, and then we'll set our sights on rolling it out in other countries. Staying with cancer, but moving on to our CaptureSeq technology. Volition is, I believe, the first company to demonstrate the isolation analysis of greater than 99% pure circulating tumor-associated DNA.

Cameron ReynoldsGroup CEO

Most current liquid biopsy methods involve deep sequencing of plasma DNA and bioinformatic analysis of the data produced to identify the presence of cancer in a patient. The biggest problem facing all liquid biopsy methods worldwide is that the vast majority of the circulating DNA in blood plasma established from cancer patients comes from healthy cells, not from the cancer. Volition's technology employs an entirely novel approach to liquid biopsy that has overcome this hurdle and produces pure cancer-associated plasma DNA sequences set for liquid biopsy. Our clinical paper detailing this technology has been peer-reviewed and published subsequent to quarter end. The manuscript describes a new liquid biopsy chemistry for isolating CTCF DNA from plasma.

Cameron ReynoldsGroup CEO

Our 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 cancer patients is therefore derived from the cancer. In the published paper, we report a new two-step method for preparing pure circulating tumor DNA data sets for cancer patients. Firstly, through physical enrichment of the sample and secondly, through bioinformatic removal of virtually all background non-tumor cell-free DNA sequences from the DNA sequence data set. These methodological and biological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers. CaptureSeq shows potential for both a multi-cancer early detection approach, either alone or in combination with other tests, and the detection of minimal residual disease, MRD.

Cameron ReynoldsGroup CEO

Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our strategy in the vets market. 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 CaptureSeq technology, and we are in the process of undertaking technical evaluations with potential licensors. We believe the potential use cases for CaptureSeq 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 use, and should it prove useful, over $13 billion for MRD use. From a Nu.Q Vet perspective, we made solid progress with our research into the use of Nu.Q in cats, most notably with our submission for peer review, our clinical manuscript.

Cameron ReynoldsGroup CEO

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 detects 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 cats in the U.S. alone, 25% of which are senior cats, and thereby suitable for an annual check. We believe this represents a tremendous commercial opportunity for VolitionRx.

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