VolitionRx Limited (AMEX:VNRX) Q3 2023 Earnings Call Transcript

Tom Butera: Yes. The feline test right now is in its pre-analytics stage. We’re going through pre-analytics right now. And then we’re going to go through more clinical studies in 2024, early part of 2024 we’ll be producing a paper on it by the first half of 2024. And then the anticipation is and the hope is that we will have cancer screening tests coming out of it that we can utilize in probably hopefully the second half of 2024. Once that is there, that should trigger a payment from Heska with reference to the fee line program and particularly with reference to cancer in the cats.

Tim Moore: Great, thanks. That’s it for my questions.

Cameron Reynolds: You’re welcome.

Tom Butera: Thank you. Have a great day.

Operator: The next question comes from [Indiscernible] with Zacks Investment.

Unidentified Analyst: Hi, good morning. Just a quick question on the R&D expenses. They were lower in the third quarter than the first and second quarters of ’23. Do you think that was due to the winding down of the U.S. clinical activities or the expense rationalization program? Or was it some other factors?

Terig Hughes: So as I think we’ve mentioned, we’ve had about $1 million cash expenses in the quarter related to the DxO studies for the sepsis trial in the U.S. We don’t — we want see that in the next quarter because those have now wound down. We have begun to see some savings from the rationalization program. But in our business, expenses are pretty lumpy. It’s very difficult to see smooth trends from one period to another. But what I can say is in terms of the underlying cash burn, we do expect that it’s going to come down a little bit from here on.

Unidentified Analyst: Great. Yes, thank you. And then just another quick one. At ESMO, I think you started to see some clinical results from the efforts from the National Taiwan University. Do you know when you might expect some results in the U.S. the IDN study?

Cameron Reynolds: The process for the long side has been quite active on both fronts. So we’ve wrapped human oncology together with the transcription factors. And the actual data itself, I can get back to you.

Louise Batchelor: So in terms of it’s Loui Batchelor. So in terms of the pace of the paper is now being written up by the National Taiwan University Group with led by Professor Chan. So they’re working on a clinical paper that will then be submitted for peer review and publication. And then what we’re looking to do from a lung cancer point of view now in terms of that specific application is a validation project, which is likely to be in another market that we haven’t yet finalized that study in order to announce that.

Cameron Reynolds: And of course, there are a lot of results coming out of France as well. And we expect the first clinical use of Nu.Q in human oncology to be in France early next year in lung cancer, Dr. Pan’s facilities. So it’s made progress. And I think something we should reiterate quite a lot as well. The transcription factor is incredibly exciting, but Nu.Q platform itself is still very much a part of what we do, very active in the vet space, of course. But also it has still a strong place in the human space. So human oncology will be a strong mixture, I think, of our Nu.Q platform and the transcription factor platform going forward.

Unidentified Analyst: Thank you very much for taking my questions.

Cameron Reynolds: Thank you. Have a great day.

Operator: The next question comes from [Ilia Zabka] (ph) with Freedom Broker. Please proceed.

Unidentified Analyst: Yes, good morning, and thank you for taking my question. Congrats with progress in the quarter. Could you share any details on the expected regulatory path on Nu.Q NETs in U.S. What steps are left to go through the — to go through to get FDA clearance.

Cameron Reynolds: Absolutely. Good question. So of course, we have been very active with the FDA. And just starting off, it’s very exciting. So the rubber hit the road, if you will, to be in such active discussions with the Food and Drug Administration is a very exciting milestone for us. So obviously, we submitted a process and what we discussed last time is we’re keen to either get a breakthrough designation status or a clear path through a 510(k), which is potentially a very clear path. And as we talked about, we’re very happy to say we do have a clear path now. The past itself is the 510(k) past and takes depending on the process and what data you need, but usually about 2.5 years from start to finish to get FDA approval.

And obviously, I discussed a lot. We understand the conditions we’re in now in the macroeconomic environment. So we’re looking to fund our projects so that we don’t — we can live to a very minimum any dilution from the top company. So we’re working on ways to finance the net process. Obviously, we’ve had a lot of Belgium assistance, and we’ve had some more coming through. We’re also looking for similar funding in the U.S. and also looking to package up this to get a large diagnostic companies or one of the large digesting companies perhaps interested in sharing the development costs to get through the FDA. So we have a very clear half now, which is exciting, and we will be pressing the button once we’re comfortable with the funding routes to get us where we need to get to.

And in Europe, it is actually salable now, as you’re probably aware, through our IVDD approval. So now we’re doing market studies for marketing studies, if you will, to get adoption for clinical utility. So that will be coming out. And we’re also looking for a group to help fund the IVDR, which is the longer-term European approval process, which is now taking over. So overall, we have a very clear path in Europe and in the U.S. And — but we’re just very mindful. We don’t want to start spending a lot of money into. We’ve located the finance for it. It is nondilutive fashion as humanly possible, and that’s all in the process now. So we should have a lot more information on that through the year. But the bottom line to your question is about 2.5 years from when we press that button to the FDA.

Unidentified Analyst: Great. Thanks a lot.

Cameron Reynolds : Thank you. Have a great day.

Operator: Thank you. At this time, I would like to turn the call back to management for closing remarks.