Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Fourth Quarter and Full Year 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 open for questions. [Operator Instructions]. This conference call is being recorded today, March 26, 2024. I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.

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 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 am joined today by Mr. Cameron Reynolds, President and Group Chief Executive Officer, Mr. Terig Hughes, Group Chief Financial Officer Doctor, Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary Subsidiary and Dr. Andrew Retter, currently Medical Consultant to Volition, which has recently announced due to join Volition n the role of Chief Medical Officer in April 2024. During the call, we will cover Volition's financial and operating results for the fourth quarter and full fiscal year of 2023, along with a discussion of our recent activities and upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. I'll now turn the call over to Cameron Reynolds. Cameron?

Thanks Lou, and thank you, everyone, for joining Volition's fourth quarter and full year 2023 earnings call today. We appreciate your time given the busy annual 10-K filing season. We will commence the call with a financial report from our Group Chief Financial Officer, Terig Hughes, before moving on to a prerecorded update from Dr. Tom Butera, Chief Executive Officer of Volition Vet on the rollout of our Nu.Q vet cancer test. And I'm delighted to welcome Dr. Andy Retter to the call to provide an update on the Nu.Q NET and Capture-PCR. As was announced last week, Andy will be joining Volition as our Chief Medical Officer beginning April 1st. Many of you will have heard from Andy previously, but I'd like to formally share his credentials. Dr. Butera is an intensive care consultant at Guy's and St Thomas' NHS Foundation Trust in London, where he has worked as a consultant since 2014 and leads clinical governance in critical care. He specializes in the management of severe respiratory failure, ECMO and thrombosis. Dr. Butera is the only consultant in the UK to hold dual entry on the specialist register in Intensive Care and Hematology and provides national guidance on the management of complex hematology patients in clinical care. He will continue his clinical and research duties at Guy's and St Thomas' NHS Foundation Trust after joining Volition. Dr. Butera has worked with Volition in an advisory capacity since January of 2022. To help guide the product development and clinical utility of Nu.Q NET's, a CE-Marked routine blood test to detect disease associated with NETosis, such as sepsis. The whole team are absolutely delighted to be welcoming Andy more formally into Volition. As Chief Medical Officer, he will be vital to our success, ensuring the needs of the patient are placed at the heart of our research, development and commercialization activities. It's great to have you on board, Andy. And I must say your enthusiasm for our mission and platform really helps us to fully understand the great importance of the work we do. Following Andy's update, 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 Terry for our financial report. Terry?

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 December 31 full year 2023. From a revenue perspective, we recorded revenue of $244,000 for the quarter, a 104% increase over the same period last year. For the full year 2023, we recorded revenue of $775,000 an increase of 153% over the prior year. We believe that these results demonstrate steady progress, but not yet the ramp in revenues that we anticipate. We expect revenues to accelerate in 2024 as several additional distributors come online with our Nu.Q vet cancer test, in particular, Antech and FujiVet who are both about to launch and our Nu.Q discover pipeline continues to grow. 2023 full-year revenue of the Nu.Q Vet cancer test was $475,000 a year-on-year increase of 194%, mainly reflecting sales of reference kits through our agreement with IDEXX. Revenues in Nu.Q discover for 2023 was $300,000, which reflects 107% growth over 2022. Moving on to the balance sheet. We ended the year with cash and cash equivalents of approximately $20.7 million compared with $10.9 million at the end of 2022. Net cash generated from operating activities during the fourth quarter 2023 was approximately $6.4 million and reflected the receipt of $13 million in milestone payments from Heska Corporation in December. For the full year 2023, net cash used in operating activities was $18.1 million, compared to $15.3 million in the prior year. Net loss for fourth quarter 2023 was $8.8 million, compared to $7.3 million for the fourth quarter 2022 and for the full year, $35.7 million, compared to $30.6 million in 2022. This increase was primarily the result of increased Research & Development expenditures mainly reflecting the cost of our U.S. clinical…

Thanks very much, Terig, and good morning everybody. In 2023, we supplied kits and components for over 58,000 tests, 5 times the number in the prior year. This growth demonstrates solid progress to date and we certainly expect more growth to come as additional companies fully launch our product at home in the United States and around the world. By the end of 2023, the Nu.Q Vet cancer test was available in the United States, the United Kingdom, and Ireland, Portugal, Singapore, Taiwan and Italy. 2023 was a breakthrough year for Volition Veterinary gaining such wide distribution and with such respected companies, so kudos to the team and a special thanks to our legal department. We have also learned a great deal, launching and introducing a new product in veterinary medicine, especially early cancer detection in dogs takes a tremendous amount of education to teach veterinarians how to incorporate this early cancer dialogue into their routine wellness visits. Our Nu.Q test also requires an additional cost to the client, which is part of our educational conversation in teaching doctors how to easily make this part of their wellness office visit Additionally, we are always emphasizing the affordable cost of our test and encouraging doctors to keep the test at very reasonable margins. The fact is clearly related to the very large number of dogs that they will be screened for early cancer detection. All-in-all, I believe our Volition team will look back on 2023 as a proud pivotal moment in the burgeoning field of early canine cancer detection, setting the stage to improve and extend the lives of millions of dogs in the months years to come. We have also launched the Nu.Q test with IDEXX, one of the world's leading veterinary diagnostic companies and now Heska, an Antech company…

Thank you very much for those kind words, Tom, and good morning, everybody. I'd just like to take a moment to start by thanking Cameron, Jake and the Board of Directors for working with me and inviting me to join the Volition team at such an important time. I've really enjoyed working with Volition for the last two years, and I'm really excited about leaning into and contributing to delivery of our mission purpose in the years to come. We really hope to have an impact to improve the lives and quality of lives of millions of people worldwide. I'd like to update you this morning on some of the significant progress we've made with Nu.Q NET and our new breakthrough cancer detection method, which we now call Capture-PCR. So first, starting with NETosis and sepsis. Sepsis, as you've heard me say before, is one of the leading of causes of death worldwide with almost 50 million cases annually and around 11 million deaths. Physicians made significant progress trying to address these issues in 2023, and I'd just like to recap a few highlights. In September, Volition hosted a key opinion leader roundtable event in Athens, Greece. The workshop held over the course of two days focused exclusively on sepsis and the potential role of Nu.Q NET is attended by some of the world's leading experts. Many of the attendees are operating under the umbrella of our Center of Excellence program with Nu.Q NET and have firsthand experience using assay now. The sense from the group was that Nu.Q NET potentially represents one of the biggest breakthroughs in the diagnosis and monitoring of sepsis in the last 30 years. We're moving forward with this group and I'm now working on a review article with the intention to submit it for…

Thanks very much, Andy, for providing those insights, and thanks as always to Terry and Tom for their reports. It is a real sign of the varied expertise we now have at Volition. 2023 was certainly transformational for Volition and a year we can look back on with pride. The commercialization of our transformational Nu.Q vet cancer test within the companion animal healthcare sector has led to agreements with several new global and regional partners, including last week with Fujifilm Vet Systems, Japan's leading veterinary diagnostic service provider and looking just around the corner, the Nu.Q vet cancer test will soon be available as an in-house diagnostic test through Heska and Antech company. We strongly suspect we will see very good revenue growth from Nu.Q vet through 2024 and beyond. I'm also absolutely delighted in the progress made in our Nu.Q NET's pillar, and in particular, in determining our regulatory pathway forward with the U.S. FDA, a key milestone for the company and in having a number of large-scale clinical studies due for publication later this year. Thirdly, and as we always seem to run low on time, I won't cover too much, but I would like to quickly mention Nu.Q Discover, which recorded revenue of $300,000 in 2023 and now has a pipeline of projects valued at over $1 million As a reminder, Nu.Q Discover is a complete solution to profiling nucleosomes, drug developers and scientists can work with us, access our state-of-the-art proprietary assays and realize their long term drug development needs. In this way, Nu.Q Discover is able to unlock value from Volition's IP portfolio by helping us commercialize the areas we are not going to focus on ourselves. As I mentioned, revenue in 2023 was $300,000 and we expect it to more than double in 2024…

[Operator Instructions]. Our first question is from Tim Moore with EF. Tim, please proceed.

Thank you. That was very informative prepared remarks. It was nice to hear that there's a lot of different levers being pulled and good optionality. Maybe I just want to start out with IDEXX. You mentioned there were revenues, it sounds like the end of the year that could start to come through. I'm just kind of wondering if you can talk a little bit about, it seems like have they finally finished kind of getting their standard operating procedures and best practices in place for the marketing launch? And if you can remind me, is it something like $10 per kit you're getting on those because you're assembling the full kit and shipping them?

Yes, yes, it is. That's correct. So yes, IDEXX have been great partners for the last year and a half and I think that we're putting a lot of work into really try to get the sales growing. So, I think there's an absolutely huge need for the test worldwide. And certainly, to get to where we need to get to, there's had to be some education of the customers. It's a completely disruptive technology. So, when it comes into the market, it's obviously a whole new thing for the vets as well as for the company. And so, we've been working closely with them to really get sales moving. And I think as it was mentioned several times, there were 58,000 tests this last year sold, so we sold the components for. So, it's getting adoption and obviously it's a very disruptive test. And I think also when the new platform comes through, which is actually starting on the first of next month, having it available in the lab as well as a point of care, I think will be absolutely huge to getting adoption out there. I think the more groups out there selling it whether that's IDEXX or Heska or Fuji, it really helps to generate awareness and education and getting vets used to a disruptive new technology. As we discussed, there's been nothing available in the cancer space before. So yes, and $10 a test is correct.

Thanks for that really good Japan Fujifilm Vet Systems update. That was terrific news. And actually, I had a question about feline tests. Do you think that's still maybe on track to launch maybe late this year? And when would you think you would receive the $5 million milestone payment timing?

Good question. and the first point, Fuji have done a huge amount of work before the launch. They're very organized. They're the biggest vet company in Japan. There's 60,000 vets in Japan and 12,000 fed hospitals. I didn't realize it was that big a market. It's obviously a large country and quite a rich country. So, as you probably heard from Tom and the team, the enthusiasm from the vet conference there has been very large. So, it's extremely good to get enthusiasm coming through and have a good new market. Yes, so the feline five we've been doing some work on with a range of other products looking to launch in the vet space. We're looking to get it working in cat 5th year. So, it's certainly possible this year or in the first half of next year that that payment will be made. As we talked about, an overall part of our strategy is to get as much funding as we can from non-dilutive and milestones and that would be the last of the payments due to us from Heska, the 23 million we've got so far plus this 5 million. So yes, it's definitely still in process and it's a reasonable thing to still have on the books.

My last set of questions is tied to sepsis. I mean, such a huge catalyst, gigantic market, number one killer in the hospitals. So, you have talked before about the traditional, 5, 10-K regulatory pathway. And if you can remind me, you're trying to demonstrate substantially equivalent performance and characteristics of a device already at the FDA cleared in the U.S., right? Can you can you kind of walk us through that? And I know it's theoretical, but what is the time line? I get a lot of questions from investors about, when do you think, if it does work out and you get approved, when do you think you can maybe start achieving revenues on the sepsis side?

Very good question. So, there's obviously, it's a product which has shown tremendous promise as you said. And the two things we've proven so far, what publications have shown, that's closely correlated with intensive care mortality and sepsis score, which is obviously both of which is incredibly important. As we talked about, there's a range of studies we're doing now, which will put a mountain of data, an avalanche of data coming out in thousands and thousands of patients and tens of thousands of samples beginning this month and all the way through the rest of the year with a big crescendo kind of in June. They're looking to show correlation with the sepsis III score, which sepsis is now defined as a dysregulated immune response, which is exactly what we measure. So, it's actually obviously incredibly useful. Disease severity, correlation with 28-day mortality, the duration of organ support and the length of stay in hospital. So, all of those are incredibly important to the clinician, which I think is why Andy and all the other clinicians we've been working with are so keen on them. With regards to the exact 510(k) pass, probably best get it from Andy. He was the key person in those trials. I don't want to make a mistake on that. There are quite a few predictive products, none of which measure what we measure, but there are products which have the ability to do some of this. That's why we were very lucky to get the 510(k) pass and I'm sure he can outline. I think he might be available on some later calls to go through the predicates as they were discussed. But that is something we're incredibly excited about. And I think it's if it continues to go well and every bit…

It does, it does. It's terrific color and granularity. And I have one last little related topic question. You kind of already addressed this. There could be potential for project financing. You can come from the corporate rev, government, both milestones. One question I get from investors a lot was, as things go well on the vet side and maybe that becomes positive free cash flow and self-funding two years from now, hopefully. Would you consider divesting the vet side or spinning it out to maybe cash flow fund the human sepsis trials?

Yes, absolutely. So obviously, at the moment, it is actually not from revenue because you've seen what that is, but from the milestone payments and the other payments we're getting, it's actually cash flow positive at the moment from all those other payments. $23 million obviously has been a lot from those sides. Yes, we would absolutely look to corporatize and then have it run as a separate entity, because this is just the very first test on what should be a very long pathway of products we can launch in the vet space. We mentioned feline as well. Obviously, sepsis happens in dogs and every other animal as it does in humans. And also, the human transcription factor work, we have every reason to believe it would work in animals just as well as humans and then all the other animals. So, I think going forward, our business model has been very much to develop the technology and then prove it works, get a product launch like we have in vet, like we're about to in NETosis and then make revenue from licensing it out. But I think the final step on that path would be to make it to the vet itself. And I think that's something which could well happen in the next couple of years. And actually, there's obviously been some interest from other groups. We're the only cancer detection company out there at the moment which has a product in the market. So, I think it's going to be a very attractive one. But we want to get that value curve kind of pushed up the curve by pruning felines and/or sepsis and/or transcription factors in the next 12 months. So, it's probably a two-year target for that.

Our next question is from Ilya Zubkov with Freedom Broker. Please proceed.

Good morning, and congrats for the progress in Q4. I have a question on the oncology test. Talking about Capture-PCR technology, what types of cancer are currently considered as the most promising for detection according to studies and your expectation?

That’s a very good question. So, transcription factors are actually indicative of all types of cancer because, they are, it's an epigenetic signal, which is in all the cancers. So, we've done some work in a varied range of cancers, including lung and colorectal and the blood cancers. And initially, we'll focus on the larger cancers, the more prevalent ones particularly, of course, like we have in the past, in lung and colorectal and the blood cancers because that's where we did the first work. But it certainly holds the promise of -- it's definitely going to be low cost, very easy to run, as easy to run as a proven test in blood, but certainly potential for every single type of cancer. But you would probably not develop a test for every single type of cancer. You'd probably develop the top five types or seven types, which between them account for the majority of cancer cases.

Thank you. That's helpful. And one more from me. The case test has demonstrated strong sensitivity in leukemia detection. And I'm wondering has any progress been made in its diagnostic performance for detection of solid tumors since October last year? And do you see the opportunity for improvement?

Do you mean any in solid tumors with capture PCR?

Yes.

Yes. We've done a lot of work. The first thing we've been doing has been optimizing the process to make it as quick as easy as possible and on discovery on a wide range of different targets. So yes, we've been making progress. I think Andy alluded to a paper that's in process of being published and also to make the process as quickly -- the process we announced was a prototype. We've been developing as much as we can to make it quicker, easier and cheaper and also on a broad range of solid tumors as well as the liquid tumor. And yes, we're making very good progress, and we're aiming to publish in the next few or submit it soon in the next few months and also work heavily on out-licensing. We've discussed several times on public calls that we think is a complete breakthrough. And if we continue to show selection or concentration of tumor-derived DNA it's going to have to be a must-have for anyone in the liquid biopsy business. So, we've been very pleasantly surprised with the level of excitement and the interest from a range of driven groups. And those active discussions are going on as well. And we expect to have some news on that in the coming months and quarters as well because again, we want to license it out and get upfront payments as well as a share of the upside going forward. So, expect to keep an eye on all of that in the next few months and the next few quarters.

Yes. And Cameron, if I can just ask, this is Lou actually here, I can just add. we've also presented at a number of conferences this year cancer-specific conferences. So, we've been at a prostate cancer conference, liver cancer conference and then just this last weekend, a lung cancer conference with cancer-specific posters with the CTC, capture PCR technology. And we've then got breast and CRC to come in the second quarter. So there has been some additional data presented and then we've got some as come and says further down the line with the Generation two.

Our next question is from Bruce Jackson with the Benchmark Company. Please proceed.

Hi, good morning, and thanks for taking my question. So, my first question is for Andrew. With the 500-patient study that you've just initiated is could that be ready in time for the conference in October?

I'm sorry, Andy, is actually don't answer a question but he's in clinic.

Just important into clinic. The full study won't have been finished Bruce by over this year, but we are hoping that we might potentially have some interim analyses available but we will have the results from several large-scale studies that will be presented at the October conference. So, the UMC in Amsterdam study and also the German Sepsis Group Study will be presented in October. But potentially, there might just be an interim analysis of hepatitis.

One is the perspective, Bruce, so the retrospective ones, UMC Amsterdam and the German study will be presented, we believe, but not the perspective that will be a bit slower, of course.

Okay. And then a question on the burn rate. Is it going to stay where it was last year, roughly? How is that going to develop over the course of this year and 2025.

Terig?

Good question. Bruce. So, as we mentioned just now, we ended the year with cash of $20.7 million in the bank. And we used net cash in operating activities last year of $18.1 million. So that was partly offset -- or costs were partly offset by the $13 million that we received in licensing fees last year. And what we can expect is that our costs this year will be slightly lower than they were last year. And that's partly the result of the cost-saving actions that we took at the back end of last year saving a little over $2 million on a full year basis. And our focus this year is on achieving our next licensing deals in the human space, as Cameron mentioned. So, we've also initiated efforts with respect to seeking nondilutive funding in the U.S. And again, as Cameron mentioned, we're looking at getting each leg to support itself. What we're focusing on is bringing in those licensing deal so that we can achieve upfront payments and milestone payments. And we do expect to make good progress on those by the end of the year. I would expect that we've achieved one or more licensing deals by the end of the year. And so, I'm pretty confident with the resources that we've got available to us with some additional non-dilutive funding that we're working on at the moment that we'll be able to achieve those milestones that we've got planned for this year.

Our next question is from Steven Ralston with Zacks. Please proceed.

You certainly have a lot of irons in the fire right now, more than I've seen in the past. And despite the progress you made in your R&D efforts in cancer and sepsis, I'm trying to get a better handle on your two developing revenue streams. When I look at the -- you have product categories, product and service listed and the revenue streams are in the vet and Discover areas. Could you delineate those a little better, so I can better model the company?

Terig?

Yes, sure. So -- what -- in terms of our vet revenue, we achieved about $475,000 of net revenue last year. That was up 194%. And that does not yet ramp but we expect it to start ramping this year as we bring online the two new distributors. So, we've got Antech and Fuji Vet, who are both about to launch both aggressively pricing the test in the market at under $40, both having aggressive plans for marketing and launching of the test. So, looking ahead, I think we'll see a decent ramp starting in Q2 and going into the second half of the year. So, on Nu.Q Discover, we did about $300,000 of earned revenue last year. We've also got a very good pipeline building of over $1 million of opportunities. And that's a bit more difficult to forecast quarter-to-quarter because it's very lumpy in nature because of a number of projects of different sizes and then the timing is somewhat [indiscernible] difficult to estimate. But I do expect to see strong growth over the next year and for the year as a whole. So, I think we can look forward to further strong growth in the Nu.Q discover projects. Did that answer your question?

I think so. In other words, some of the Discover revenue is -- well, discover revenue is classified both under product and service categories.

That's right. It is. So, we -- it's probably slightly more weighted towards the service than the product.

Is it too early in the process to determine the relative profitability between Discover and Vet?

So, both are highly profitable in terms of gross margin. Vet, I would say, is probably higher or more highly profitable once we get it to scale and Discover although highly profitable, there's a service element there and that makes it slightly less profitable, but still we have very, very good gross margins on both products.

Also, is there a corporate model of when to capture your deferred revenue? I know it's a long tail and a very large market, and it might be too early to determine that, but you are generating some sales in that and therefore, some miniscule percentage of the deferred revenue should be coming over through the bottom line, well, being put into the top line to come

Yes, that's a good point. And I'm glad you brought that up because as you know, we've received about $23 million so far in payments related to the license agreement with Heska now Antech. And that's currently classified as deferred income on the balance sheet. And I do expect that to start earning out this year because it's linked to when the point of care or in-house diagnostic test launches with Heska, which is, as we said, is imminent. And so, I do expect to start to see some of that burning this year, but is a long tail over the lifetime of the agreement, which is 20 years.

Thank you. Just two comments. I'd like to thank you for those informative webinars on cancer and sepsis. I've listened to them several times. Every time I listen to them, I get more out of it. and also, that the $2 million cost cutting was not unnoticed, it came all below my expectations with the lower cost.

We have reached the end of our question-and-answer session. I would like to turn the conference back over to Cameron for closing remarks.

Thank you, everyone, for attending our call. We really appreciate it. And we look forward to updating you with all the developments that we've outlined over the next few months and on the first quarter earnings call, which is, of course, due in mid-May. So, thank you very much, and have a great day. Thank you.

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