Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limited Third Quarter 2023 Earnings Conference 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. [Operator Instructions] This conference is being recorded today, November 15, 2023. I’d now like to turn the conference call over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you and welcome, everyone to today's earnings conference call for VolitionRx Limited. This call will cover Volition's financial and operating results for the third quarter of 2023, along with a discussion of our recent activities and key upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, President and Group Chief Executive Officer; Mr. Terig Hughes, Group Chief Financial Officer; Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary Subsidiary, and Dr. Andrew Retter Medical Consultant to Volition. 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. 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. I would now like to turn the call over to our President and Group Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thanks, Scott, and thank you, everyone, for joining Volition's third quarter 2023 earnings call today. We especially appreciate your time given this is the busy earnings call season. We will commence the call with the financial report from our Group Chief Financial Officer, Terig Hughes, before moving to Dr. Tom Butera, our Chief Executive Officer of Volition Veterinary; for an update on the rollout of our Nu.Q vet cancer test. And then I'm delighted that Dr. Andy Retter, who works as a hematologist and intensive care consultants at one of the U.K.'s leading hospitals has prerecorded his thoughts on our progress in our new net pillar. And in particular, the result of our FDA meeting achieving a clear regulatory pathway and also of our recent breakthrough early cancer detection method recently presented at ESMO in October. I will wrap up with my thoughts and upcoming milestones and discuss our overall strategy going forward. Without further ado, I'll hand you across to Terig for the financial report. Terig?

Thanks very much, Cameron, and thank you, everyone, for joining our earnings call today. I'll now provide a summary of the key financial results for the quarter ended September 30, 2023. From a revenue perspective, we recorded revenue of $165,000 for the quarter, a five-fold increase over the same period last year. During the first three quarters of 2023, revenue grew 185% to $531,000. We believe that these results demonstrate steady growth, but not yet the ramp in revenues that we anticipate. We expect revenues to accelerate as we close out 2023 and into the early part of 2024, as several additional distributors come online with our new Nu.Q vet test and our Nu.Q Discover pillar continues its growth. Year-on-year revenue growth was primarily driven by sales of the Nu.Q vet cancer test, which grew almost fivefold over the nine-month period ended September 30, 2023, as compared to the prior year period, reflecting sales of the reference kits mostly through our agreement with IDEXX, who we are working closely with on their marketing and expansion plans across the U.S. and into international markets. Revenue for Nu.Q Discover for the first three quarters of 2023 was $151,000, which reflects 38% growth over the comparative period in 2022. Looking ahead, as we have previously stated, it is difficult in these early stages of commercialization to provide meaningful revenue guidance. But as both Tom and Cameron will cover in their updates we are pleased with the progress we are making across a number of our product pillars. We ended the quarter with cash and cash equivalents of approximately $10.8 million, compared to $10.9 million at the end of 2022. The Net cash used in operating activities during the quarter was approximately $8.4 million and included payments of almost $1 million related to our…

Thanks very much, Terry, and good morning, everybody. I am pleased to report that in the first nine months of 2023 revenue for the Nu.Q vet cancer test grew almost five-fold over the comparable prior year period, reflecting sales of the reference kits to our global, regional and local supply agreements. The revenue growth demonstrates solid progress to date, and we certainly expect more growth to come as additional companies fully launch our product, both in the U.S. and around the world. As you will have seen in a recent announcement, our Nu.Q vet cancer test is now available in the U.K. Indeed, I am taking this call from London, England as the team is in town for the London vet show over the coming days. We were thrilled the launch of our Nu.Q test was featured in an article of the Sunday Times, one of the flagship papers here in the U.K., really terrific exposure. The London Vet Show is Europe's largest veterinary exhibition with more than 20% of U.K. vets attending the event. So we are looking forward to a busy few days, not only in the exhibition hall, but we also have a series of sponsored and invited talks on Friday with Dr. Sue Ettinger and Becca Timmins. There are 11 million pet dogs in the U.K. with 29% of the households owning one or more dogs, so we believe that the U.K. market provides another tremendous opportunity to drive access to our early detection test. We are delighted to be supplying two of the leading veterinary diagnostic providers in the U.K., nationwide laboratories and veterinary pathology group both of them will also be promoting the Nu.Q vet cancer test at the London Vet show. We expect exciting times ahead on this side of the pond. We…

Thanks very much, Tom, for that introduction, and good morning, everybody. I'm delighted to join the call today and provide an update on some of the significant progress made with Volition's Nu.Q NETs in cancer pillars. So starting first with Nu.Q NETs sepsis, which is how I first was introduced to Volition. Sepsis, you've heard me say before, is one of the leading causes of death worldwide with almost 15 million cases annually, leading to, unfortunately, around 11 million deaths. There is ongoing discussion about the diagnosis and definition of sepsis. Volition has made significant progress this quarter, which is carried through into the fourth quarter. In September, we hosted a key opinion leader roundtable event in Athens, Greece. This workshop held over the course of two days, focused exclusively on sepsis and the potential role of Nu.Q NETs. It was attended by some of the world's leading experts, including three authors of the highly influential and critical sepsis three clinical definition paper. The current chair of the International sepsis form and the current chair of the European sepsis Alliance and many other attendees are operating as a center of excellence within the Nu.Q NETs program. And so have first-hand experience of the assay. We desperately need new diagnostics and new tools to measure the progression of sepsis, and this may lead to new therapeutics. The sense from the group was that Nu.Q NETs potentially represents one of the biggest breakthroughs in sepsis and the management of sepsis in the last 40-years. If you would like to find out more about the KOL meeting, the short report was issued and is available in the Download section of the Volition website. Moving forward with this group, I'm now working on a clinical review article with the attention to submit it for…

Thank you very much, Dr. Andy Retter for providing those insights, and thanks as always to Terig and Tom for their reports. It's a real sign of the varied expertise we now have at Volition. 2023 thus far has certainly been transformational for Volition. But before I reflect on that, I'd like to take a moment to elucidate our financial strategy. Given the current macroeconomic conditions, we are focusing on getting each pillar to support itself either through product revenues, milestone payments, out-licensing or other non-dilutive funding by the end of 2024. We are currently targeting the following: we expect Nu.Q Vet to be overall cash flow positive from now on through milestone payments and the expected revenue ramp as more partners launch and our existing partners expand into new territories. We expect Nu.Q Discover to more than double revenue in 2024 and to become profitable starting in 2025. We're running out of time to cover Discover separately on this call, but overall, we are very happy with progress with nine contracts signed already and a further 10 currently in negotiation. Thirdly, we have begun a strategy to fund, as Terig alluded to earlier, our Nu.Q NET through nondilutive and/or project funding of up to $25 million. We have targeted a range of government agencies in the U.S. and Europe and are also preparing the background work aimed at attracting a large player to either out-license or invest in the product directly. Fourth, lastly, as discussed by Gael Forterre, our Chief Commercial Officer, in our recent webinar, there has been a lot of external interest in our CTCF and Nu.Q cancer technologies. Our strategy is to license this out to one or more larger companies as the commercial undertaking of this size is likely beyond our current capabilities. If successful,…

Thank you. We will now conduct a question-and-answer session. [Operator Instructions] Our first question comes from Ross Osborn with Cantor Fitzgerald. Please proceed.

Hi, everyone. Congrats on the progress and thanks for taking our questions. So just wanted to focus on Nu.Q Vet today, given it's the most near-term revenue opportunity. So with regards to the U.K. market, how much coverage do you think the two reference laboratories have there?

Yes, great question, Ross. Thanks for asking it. I think we're going to have broad coverage for the U.K. Both of these labs nationwide and VPG have extensive coverage in the U.K. throughout and also VPG also has penetration into Ireland. So the answer to your question quite simply is broad coverage.

Okay. Great. And then maybe turning to IDEXX, could you remind us the go-to-market strategy there just in terms of marketing reach and current capacity?

Yes. IDEXX, obviously is both a domestic U.S. company and has tremendous international exposure as well. They're currently -- we've been working with them or obviously, over the course of their launch since January of VMX. And they are highly engaged with us at the current time. They are obviously an extremely large company. Lot of moving parts. We had some early hiccups in the reference labs initially, which we have now smoothed out, and they're working very well. And also, we are extremely engaged with them in terms of collateral support and collaborative support on their educational awareness, and they are planning expansion in both domestically, as well as internationally in 2024. So we really, quite frankly, even though the ramp has been a little bit slower, one has to realize this is a new concept and a new discipline that's being brought to veterinarian cancer detection, but they are highly engaged with us, and we anticipate a significant ramp-up over the course of 2024.

Okay. Great. And then last one, and I'll jump back in the queue. You mentioned your intention to commercialize in Japan and Taiwan in 2024. Could you just walk through the rationale for targeting those geographies specifically?

Yes. To give you an idea, first of all, Japan, we're talking about a companion animal market of over 22 million dogs and cats, a pretty significant number. I mean we're talking in the U.S., 84 million. So that's a pretty large number compared to the U.S. In Japan, we're talking about 11,000 hospitals. In the U.S., we're talking about 26,000 hospitals just to kind of give you some reference points. And then we have Taiwan who's quite frankly grown 49% growth in their companion animals over the last four years, and they're up to somewhere over 2 million pets, dogs and cats in the current market right now with about 1,600 veterinary hospitals. So I think between those two, giving you some numbers and comparing them to the U.S., you can see they are very nice opportunities for us and considerable potential expansion for us in both of those countries.

Thank you for taking our questions. Congrats again.

Thanks, Ross.

Thank you. Have a great day.

The next question comes from Bruce Jackson with the Benchmark Company. Please proceed.

Hi, good morning and thanks for taking my questions.

Thank you.

So just a couple of cash flow questions. First on the payment from Walloon, is that going to hit in the fourth quarter? And then how much of that goes on the cash flow statement and how much goes to the income statement?

That's a good question. It will all go to the cash flow statement. It's cash that we will get in, in the next month. We're also expecting more from a national level body in Belgium, probably early Q1 next year. But these are in the form of funding similar to what we see before where we've had $19 million of funding from the Walloon region in Belgium is as a combination of grants and soft loans, and that helped us to finance a lot of the operations, including our Silver One production facility in Belgium. And we're very grateful for the support that we've had from Belgium and the Walloon region.

Okay. And then same question for Heska. What's the timing and the amount of the milestone? And then how does that flow through the income statement?

So the milestone will occur when Heska launches the product. How that flows through the income statement. It's a milestone payments so similar to the first one that we received. We received $10 million upfront, if you recall that. That goes on to the balance sheet as a deferred income and is then earned out as we make future sales.

But as before, we could use them all immediately on arrival, if you will, for the company. So they're all very much part of working capital.

It's all cash in the bank. So you'll see that cash on the balance sheet and it’s available to us when it's -- when we collect it.

And Bruce, if you add it all up with the two -- the amounts we expect in -- from the regional funding and the Belgium funding as well as those milestone payments on the launches. You're looking well into the $20 million range -- over $20 million. So obviously, a very big part of -- the money will lead to get the milestones reached next year.

Yes. Perhaps I can add to that with that funding with the milestones, with the money from Belgium with what we've got currently we do have line of sight on funding from the end of Q3 through the next 12 months.

Okay, super. Last question on the CTCF research. I think you mentioned during the last webcast that there would be some more data coming out during the first quarter. Is that still the case?

Yes, absolutely. So obviously, it was very good preliminary data, and we've had a lot of interest from partners, which we're very excited about, and it is bigger than us. So we're very excited. But of course, we're working all the time not only on more data, which is obviously very important in a range of cancers which we aim to be presenting at specific conferences for those cancers as well as we're working on the -- it has not been optimized at all. So we're going through all the things to optimize it to make it as simple and easy as routine as possible. And also the optimizations should also help with the overall accuracy. So overall, I think, as you know, Bruce, I'm a very optimistic person, but I'm very happy and a little surprised how quickly it's actually gone even since ESMO with the level of interest and Jake at the conference next week, the [Indiscernible] conference also in Madrid. So we're talking to a lot of our other potential partners there. So expect to see a lot of information through this year and into next year and data as we said in Q1.

Alright, great. Thank you for taking my question.

Our next question comes from Tim Moore with EF. Please proceed.

Thanks. For new investors joining this call, maybe can you provide some anecdotes on how that's fine, your testing kits exciting and useful in conveying that excitement K9 dog owners. Can you give any kind of interaction anecdotes or color behind that? It's a rapid outcome test, but vets seem to be buying into the adoption of the early cancer detection and probably spreading the word. I mean any sense of that awareness for this rapid testing of cancer, you think like one-third of that's know about it already?

Yes. Thank you for the question. As I mentioned earlier in the call, early cancer detection is a new test and a new area of involvement for my veterinary colleagues. So we are obviously going around the world in terms of conferences where we're speaking to both general practitioners as well as oncologists and also obviously spending a lot of time in the U.S. going to major meetings. So what we're actually doing, there is robust interest in the cancer screening has, and they are learning from us as well as our partners on how to use the test and how to communicate it to the clients and how to bring it into their normal workload and normal examining patterns when they interact with their clients and their pet owners. So consequently, the interest is significant. We're spending a lot more time on how to use the test now and how to communicate it and then what to do after you get something that comes back normal. But -- so you know the overall message with a screening test is one of piece of mines, close to 92% of the dollars that get -- 92% of the dollars are going to come back in a normal range, and you have 6% to 8% potentially better in a higher range. But unfortunately, in the United States, we're 6 million dogs a year level cancer, it's a large number. So overall, the education continues with IDEXX, with our partners, with Heska and also with my own team, the Vet team here Volition, and that is an ongoing thing that we will continue to do throughout 2024 and 2025. But the interest has been robust. The use is increasing dramatically, and we're very excited about how our veterinary colleagues have received it.

That's great color. I appreciate it. My next question is about Heska in the milestone payments that possibly to be received over the next several months. Is it fair to just assume that with any companies that get taken over like the Mars takeover, that might have slowed down the milestone payment, but is it possible that Heska maybe launch both screening and monitoring at the same time that you can get a double milestone payment?

Yes, I think that's a great question. To answer the first part of the question with reference to the acquisition of Heska VMRs, that really, quite frankly, hasn't slowed down the optimization process that we've been doing on the point of care. As I mentioned in my earlier comments, on the video that we have done today, we're talking about a tech transfer going from a reference lab test to a point-of-care test, which is something that my veterinary colleagues use in their veterinary hospitals. It is a major accomplishment to do something like that. And consequently, it has taken some time to do it and it's gone a little bit longer than we anticipated. But we're almost there. And when you think about it from a 12-month period of time when this was started to where we are now, it's a tremendous accomplishment where we're getting very close to a launch. So that point is well taken and hopefully, understood.

[Multiple Speakers] screening.

Yes. The good part about screening and monitoring. Since I've been in the field of Veterinary Medicine for a number of years. What you really want to do is you want to make sure that you're getting your message across to the colleagues on not too many things at the same time. We want to be very clear on our Nu.Q cancer screening test, which is our first test and make sure they're using it, using it effectively. And that is the direction we're going in right now. And obviously, it's out there and thousands of tests have been run at this point in time, and we'll continue to do that. We will be entering the market with our monitoring application. We already have a peer-reviewed paper that came out in May of 2022. We are talking about it with our colleagues extensively, but we don't want to mix confuse the message. We anticipate that the monitoring application will probably really be introduced probably more like in the first quarter of 2024. And yes, to your point, will we get kind of a double with that between the screening and monitoring, of course, because both of those tests will interact with each other, and it will obviously bring even more credibility to both screening as well as monitoring. But we're focused on the screening first, and now we're continuing our education of the doctors on the monitoring, and that will follow suit after that.

Great. That's helpful. And my last question is just what do you think might be the time frame of the feline test launch? Is that more of December next year? And can you remind me when that does occur, does that trigger a $5 million milestone.

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.

Great, thanks. That’s it for my questions.

You're welcome.

Thank you. Have a great day.

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

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?

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.

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?

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.

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.

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.

Thank you very much for taking my questions.

Thank you. Have a great day.

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

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.

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.

Great. Thanks a lot.

Thank you. Have a great day.

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

Thank you, everyone. There's a lot to be taking in at the moment. There's a tremendous amount going on in the company. And I think as you've probably taken from everything we've said, we're tremendously excited with all of the pillars now, which are really coming through. But of course, in this environment, that excitement is tempered with the knowledge that we have to be very careful with our capital, which we have been. We have a lot of sight to a lot of incoming money, which we've talked about. We're also pushing for as many other ways of funding what we do with as well as possible non-dilutively. So we'll have a lot of information through the rest of the year. So we're looking forward to hopefully what's looking to be a strong beta through next year as well as the other exciting breakthroughs that we have. So thank you very much for your time, and I'm looking forward to speaking to you all soon with updates in all of our pillars. Thanks for your time.

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.