VolitionRx (VNRX) Q2 FY26 earnings call: the analyst Q&A

How will the point-of-care lateral flow NETosis test be applied given its slightly lower accuracy compared to the CE Mark central lab test, and how does it fit into the market strategy?

The central lab test will likely be common in many places as part of normal blood work. The lateral flow test, despite a 90% correlation, expands the market by enabling rapid, point-of-care testing (finger-prick) for quick clinical decisions, especially in developing countries or for at-home use. It doesn't replace the lab test but opens new avenues, particularly where infrastructure is weak or time is critical. Its strong correlation with the gold standard CE Mark test will aid regulatory approval.

“The point of care opens up, it doesn't, by any means, replace a lab. That's the easiest, quickest way for most people to have the test, but I think it opens up a lot of other aspects.”

asked by Michael Okunewitch · answered by Cameron Reynolds

Can the point-of-care lateral flow format be developed for other Nu.Q tests, such as Nu.Q Cancer?

Yes, the technology is broadly applicable. What is developed for sepsis (H3.1) or other nucleosome assays can theoretically be applied across all Nu.Q ranges, including human cancer and animal applications. The underlying principle of detecting nucleosomes is versatile.

“in theory, everything we develop in either humans or cancer or NETosis sepsis is applicable in animals. It's applicable in all of our range -- of all the nucleosome assays.”

asked by Michael Okunewitch · answered by Cameron Reynolds

How will the lack of specific breed risk factors in cats impact the screening market for the feline cancer diagnostic compared to dogs?

While the cat market for vet visits is currently smaller than dogs, there is no existing cancer test for felines, making Volition's assay a significant unmet need. The lymphoma data (97% specificity, 86% sensitivity) is excellent. The market is still potentially lucrative with millions of eligible cats, especially senior ones, despite fewer vet visits. It will likely be a smaller market than dogs but still large, with high margins.

“as of today, there's absolutely no current market for any cancer test. There's no cancer test out there in the feline market.”

asked by Michael Okunewitch · answered by Cameron Reynolds

Provide additional color on the reimbursement approval process for Nu.Q Lung Cancer in France, potential risks, and comparison to other regions.

The French government is encouraging new tests. Volition had a pre-submission meeting and is hopeful for approval. The process is different from the U.S. and has inherent risks, but the company is happy with its progress and expects news later this year, with clinical use in France next year.

“We are very, very happy that we're in this process with the French government, and that will allow us to collect a large amount of data once the reimbursements are working in France and start helping people.”

asked by Justin Walsh · answered by Cameron Reynolds

How much of H1 growth was one-time vs. organic, and should quarterly revenue inconsistency continue?

Q2 revenue had a 50-50 split between deferred revenue (from Heska agreement) and actual product revenue. Quarterly revenue is expected to remain lumpy and difficult to predict due to large orders and project-dependent Discover Services revenue. While a good pipeline of projects exists, timing depends on partners. The company expects full-year growth but not quarterly smoothing soon.

“At this stage, and that's why we're not giving guidance, it is particularly lumpy. And we're not expecting it to smooth out anytime soon.”

asked by Unknown Analyst · answered by Terig Hughes

What is the latest thinking on the timing of receiving the $5 million feline milestone payment?

The paper has been submitted and is in peer review. It's taking longer than hoped, but publication is expected, which will complete the obligations for the milestone payment.

“The paper has been submitted, as you know, and it's still going through a peer review process. We are waiting for reviewers comments to come back. It is taking a little bit longer than we had hoped.”

asked by Bruce Jackson · answered by Terig Hughes

Given the high correlation of the finger-prick test, will clinical trials be required, and what is its regulatory pathway?

The next steps for the finger-prick test involve moving it to research use only (RUO) status, followed by clinical validation in three independent hospitals, expected to start in early 2027. While high correlation helps, regulatory work will still be needed, but it will be easier if it agrees with current approved lab tests. The gold standard remains the Revvity machine.

“The next stage is that it then will make the assay into research use only status so that it goes through some more quality checks, et cetera. And then it will be tested again in 3 independent hospitals for clinical validation. So that will then be the clinical validation stage that we hope to start in early 2027.”

asked by Steven Ralston · answered by Louise Batchelor Day