Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited First Quarter 2024 Earnings Conference Call. [Operator Instructions] This conference call is being recorded today, May 14, 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 may 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 any obligation to update any forward-looking statements made during the course of this call. We will start the call today with Terig Hughes, our Group Chief Financial Officer, who will cover Volition's financial and operating results for the third quarter of 2024, along with a discussion of recent finance activities and the look ahead. Dr. Andrew Retter, our recently appointed Chief Medical Officer, will provide a commentary about our clinical trial program and then Gael Forterre, our Chief Commercial Officer, will summarize some of the key commercial achievements this quarter with a look ahead to upcoming milestones. Lastly, Cameron Reynolds, our President and Group Chief Executive Officer, will provide a brief wrap-up before we open the conference call to a question-and-answer session. I'll now turn the call over to Terig.

Thanks, Lou, and thank you, everyone, for joining Volition's First Quarter 2024 Earnings Call today. We do appreciate your time given the busy earnings season. I'll now provide a summary of the key financial results for the quarter ending March 31, 2024. We ended the quarter with cash and cash equivalents of approximately $11.8 million. Throughout this quarter, we have continued to work on a number of threats with the aim of ensuring Volition is cash flow neutral in 2025. We are making strong and necessary decisions to preserve capital in the company whilst ensuring we deliver on our vision and mission. Firstly, from a funding perspective, as you are probably aware, throughout the company's history, we have been successful in securing nondilutive funding on favorable terms and year-to-date, we have targeted a range of government agencies, including in the U.S., to fund or co-fund some of our strategic projects up to $25 million. In addition, we have applied for or are in the process of applying for an additional $18 million from various European agencies. As a reminder, we have previously received over $20 million in nondilutive funding support from various Belgian and European agencies. We will provide further updates on this in the coming months. Secondly, as Andy and Gael will cover later, we are working hard to complete the materials for our data rooms during the second quarter for Nu.Q NETs and Capture-PCR to enable licensing negotiations to move forward. If successful, we believe that this strategy, like the approach we took with Nu.Q Vet could provide us with ongoing royalties and very meaningful milestone payments in the next 12 months. Thirdly, now that we expect that we are very close to receiving large amounts of data for both Nu.Q NETs and Capture-PCR, subsequent to quarter end,…

Thank you very much, Terig, and good morning, everybody. Thank you for joining us today. I will start by reiterating my conclusions from our last call just a few weeks ago now. I believe that Volition's technologies will not only help with diagnostics enrichment, but also with monitoring of patient disease progression and response to treatment. And most incredibly, we should be able to accomplish these goals with a relatively low cost, easily available routine blood test, which can be used widely around the world. We have certainly made excellent progress towards achieving these emissions in the last year. Starting first with Nu.Q NETs and Sepsis. I wanted to highlight a couple of studies, which we hope will provide strong clinical utility evidence. We have ongoing analysis of 2 large-scale retrospective sepsis cohorts in Europe, the German sepsis group and work with our team at UMC Amsterdam. This will encompass over 2,500 patients with longitudinal samples. We hope to characterize cohorts of patients with sepsis, and this should be a really rich and valuable source of insight into the value that's page 3.1 that Nu.Q NETs offers. These samples have now all been run, and we're working on the complex process of data analysis. We aim to have this completed by the end of next month, but we'll have data ready to show soon afterwards. We extended the [indiscernible] study in the U.S. to include sicker patients and for patients to be initiated from the emergency department rather than simply ITU. This plan is to close out this study in the coming months. In summary, across all the studies to date, without data covering patients from the emergency room presentation through to intensive care unit's mission, we will cover key outcome measures with Nu.Q NETs correlated with the Sepsis-3 diagnostic…

Thank you very much, Andy, and good morning, everyone. Before I discuss the data rules and our ongoing commercial discussion, I would like to reflect on our progress so far licensing and commercializing our technology. In relation to the Nu.Q Vet tests, we have received $23 million so far, 10 million upon signing the exclusive agreement for the in-house diagnostic test with Heska, Antech, which is part of the Mars Petcare Group. We then subsequently received 13 million upon the achievements up to milestones in December 2023. On an ongoing basis, under this agreement, we will also receive payments for the supply of the key component for the Nu.Q Vet cancer test on the Element I+ in hospital platform. We have also exhibited a number of non-exclusive reference lab supply agreements for this test with global and regional veterinary diagnostic companies. This includes IDEXX Laboratories and most recently Fujifilm Vet Systems. It is safe to say that we have made significant progress in making our test accessible to veterinarians in a number of major markets in the U.S., Japan and many European countries, not only through the reference lab network, but also now available in hospital at the point of care to give results to the veterinarian in less than 10 minutes. These countries are home to around 150 million pet dogs, so they represent a significant market opportunity. As Tom has mentioned on previous calls, cancer screening in the veterinary market is a new concept and certainly while there is significant interest, it is taking time to properly launch, educate, convert and scale. Through the recent launches by Antech and Fuji, not only have we seen significant engagement from their teams and the support of several KOLs, but notably they are both offering the test at a very competitive…

Thanks, Gael, and thanks too to Andy and Terig for their comprehensive reports. In drawing to a close, before I highlight some key points, I would first like to take a moment to acknowledge the tireless dedication, hard work and encouragement of our retiring Executive Chairman, Dr. Martin Faulkes. Bill has been with us since the company’s very inception 14 years ago. But having recently celebrated his 80th birthday, we’ll now continue to support us as a long-term shareholder and mentor. Thank you, Bill, for your counsel and thanks also to the outgoing board member, Ed Butcher, for his many years of service. We are active in our search for a new chair and indeed direct us as we seek to further strengthen the commercial acumen of our board. Our focus continues to be on getting each pillar to support itself either through product revenues, milestone payments, our licensing or other non-dilutive funding in the coming year as well as on the company wide cost reduction measures of a further $10 million outlined by Terig earlier. This is to ensure as little dilution as possible towards being cash flow neutral as early as possible and then drive on to profitability. We expect Nu.Q Vet revenue to increase in the second half of this year now that Antech and Fuji have launched the products and as existing partners expand into new territories. We’re also focusing on the feline product development to secure the final milestone payment of $5 million from Heska Antech. We are also very actively targeting a range of government agencies and currently going through the process to secure further non-dilutive and or government project funding in the range of $25 million in the U.S. and a further $18 million in Europe. Lastly, as discussed by Gael, there has been a lot of external interest in our Nu.Q Capture-PCR and Nu.Q NET technologies. We have made strong progress through the first half of 2024 in getting the data required and our strategy is to monetize our IP through licensing agreements as we did invest. We expect a very large amount of data to be completed by the end of next month in the two key areas of Nu.Q NET and Capture-PCR. If successful, we believe this strategy could provide us with ongoing royalties and very meaningful milestone payments within the next 12 months. In drawing this earnings call to a close, I would like to thank you all for joining the call today. We very much appreciate i,t, given how much there is to digest across all our pillars. I’m now happy to answer questions. Operator?

[Operator instructions] Our first question comes from Bruce Jackson of Benchmark Company.

The one question I had was about, you touched on this, is the lung cancer study. Is this the one that’s being done in France in Lyon? And maybe you could like give us a few more details about that.

Yes. Actually, there’s been a lot going on both in Taiwan, as you know, where it was, primarily a test in conjunction with low dose CT scanning, and results have been, very good there, and that’s being published soon with the aim of putting that as part of the Taiwanese screening program, and we’ll be updating a lot more on that later. And, also, the lung cancer work, and this is all with our original Nu.Q platform, not even our new Capture-PCR. So it’s kind of -- it’s funny. Everything’s kind of working at the same time. After a lot of years of, only having 1 or 2 products and that, it’s a mixture of perhaps deciding who goes to palliative care and who goes to treatment, and that’s also worked very well. And they’re also keen to use that clinically as well. So, obviously, with all the work that’s going on now with, the sepsis side, which as Andy said, is going, incredibly well, and all aside from all the other things. The focus on the product side has not been there, but it’s something which is working very well. As I said, it seems to be everything seems to be working at the same time. So we’ll put some focus on that and starting with the publications. And, both of them could be used clinically in those countries in France sometime later this year, early next year, and then Taiwan, once it’s added to the national screening program. So both of those are very exciting developments. Anyone, on the any from our team want to say anything else about the lung cancer? Nope. I covered it.

Our next question comes from Tim Moore of EF Hutton.

Thanks, and congratulations on the timing of the launches over the last 6 weeks. I mean, like you said, so many things are coming together at once pretty much since late March. That’s really good to see. I know investors have been hanging in there. You’re executing very well. And I was wondering maybe if you don’t mind giving some color and feedback. I know it’s super early, but just what are your thoughts on kind of the feedback and traction at the veterinarians? I know the rollout just pretty much started in the U.S., but vets are probably educating dog owners about it at their annual checkup for the canine test. And just anything you can add on that? Any incidental, antidotes?

Yes. There’s a lot of going on there. So I think, obviously, our existing partners, there’s been some time for them to ramp up, but I think that’s understandable. Looking at it so far, there has never been an ecology test in the veterinary space for screening. Certainly not something that’s routine and easy to run like ours. So there’s a vet by vet education process and also how to use the products. There was also, I think, a little bit of market confusion. There was another test on the market from a friend at PetDx, and that’s actually cleared now. They are no longer selling their test. It was something at a very high price point. So, it obviously it’s struggling in the market. It’s no longer around. So I think we have a clear path. I think one of the very exciting things, with the greater access that we are now developing, through the, in hospital test with Antech and with Fuji in Japan, which only just started. So we should see that coming through later in the year, has been the great feedback from key opinion leaders. If you looked at the releases from both the companies, some of the best vets in the planet were extremely excited about our product. And, going forward. Also, of course, Antech had a large validation study, before it put it onto the machine, and it’s got the machine working very, very well. So I think, from the vet perspectives, it’s a building process, which is going on in the U.S. And I think the extra access from now, as I said, the two biggest vet companies on the planet and also the biggest in Japan and also through Europe is very encouraging. And that the feedback we’re getting from the vets, and through those companies, not just our vets but also theirs, has been excellent. And we also got great feedback, most recently from Japan from their first use of the product. But this is a development process. There is a lot of work. They are going vet by vet to get them to add it to their normal process. So, it is something which is, will take some time to get through, but we have a fantastic product. It’s very low cost. The new people in, the new access through Antech and through Fuji are both less than $40 to the vet, so we expect a lot of good developments throughout the end of this year and next year.

Great, Cameron. And like you mentioned earlier in your remarks, I mean that price point below 40 was definitely very impressive, and I’m glad there’s buying on that, for initial traction and awareness? It seems like a no brainer for dog owners. The only other quick question I had was on human sepsis. You’re working hard on that. You mentioned, the patients and just the studies. Can you just give us a little bit more of a time frame around that as you look out over the next year, year and a half? Can you kind of just maybe walk us through the timeline and your plan on that because it’s a huge opportunity and everyone thinks, I think, it’s pet testing, but the sepsis could be a huge catalyst. So I’d love to hear more about the timeline?

I think the sepsis is obviously going to be a massive deal because as, Andy very well pointed out, this is an absolute potentially game changer in the diagnosis and treatment of sepsis. And our test, as we discussed, is always going to be low cost, easy to use on a range of platforms. So to get there, this is bigger than Volition. It potentially is such a blockbuster product. We don’t presume that we could launch them internationally ourselves. So we have a very similar model, which has worked so well in the Vet space to license it out. To license it out, we need a large data, which, Andy went through very well on the call. We’re expecting a lot of that in the next month or 2 to fill out the data room. We have very strong interest for a range of large companies, and I think the [clinching] for that is getting large amounts of data. And as Andy said, it’s coming up with at least 6, potential endpoints. How do we correlate with the current sepsis-3 definition, disease severity, intensive care mortality, 28-day mortality, duration of organ support, and length of stay. So it’s a huge amount of data. And the trials which we’re running, some of them have hundreds of data points per patient. So, they’re very, very large studies with fantastic institutions. Two of the big ones, they’ve run the samples already and we’re analyzing them now as Andy pointed out. So, that’s something which is coming up quite quickly. And as, of course, we’re keen to get the information out, so for our the potential partners to license the product, and we’re also aiming to publish where we can in med archive because sometimes, obviously, large publication can take several months or a few quarters to actually get published. We’re keen where we can to publish that early on med archive. So and, of course, there’s also our own prospective study, which we’re now calling INCLUDE, which was called the DXOCRO study, and that we should also be reading out in the next 2 months as well. So a very large amount of data, which with a very exciting endpoints, and we’re very encouraged with everything we’ve seen so far. And I think there’s a very good chance they’ll become the key points for the data room so we can license them as quickly as possible. And the target is to license the sepsis side within the next 12 months and hopefully the cancer PCR this year. So it’s all in the mail now, I think.

Our next question comes from Ilya Zubkov of Freedom Broker. ilya zubkov: I have a short one on the Capture-PCR. Do you see Capture-PCR test as a potential product for the biopharma R&D market beyond point of care and hospital screening? Could you elaborate on this?

Yes. I think, it’s a big, it’s a whole new technology. The first group ever to concentrate as Andy said, the chromatin, from the cancer. Also, the smaller fragments are incredibly important. And as our chief scientist points out, it’s a whole new array of biomarkers because no one’s ever looked at these fragments and concentrated them before. So there’s a lot of potential uses. The biggest market of all is screening, of course, for cancer, but also there are tremendous amounts of uses in a wide range of areas. If you look at our Nu.Q platform, which is currently, obviously, what is used in the vet space and the lung cancer trials, which we talked about just earlier. There’s a lot of work being done in our discover program. We have over a dozen organizations working with us using our platform, and some of those, drug efficacy, and a whole lot of, as you said, other ways of using it. I’d certainly expect, once we have, the paper and once we’re in the process of licensing, there’s a very wide range of uses they could use that platform for as we have as have had on the Nu.Q platform through Nu.Q Discover. I don’t think it’s possible to overstate how important, our what we’ve done is in the human space and the animal space. We’ve got the only platform, which as I said, do all the things we’ve said. So it should have a very important role in a very wide range of other uses beyond screening. Yes.

Our next question comes from Steven Ralston of Zacks.

I wonder if you could give some thought to the rollout of Nu.Q Vet, especially here in the United States, Europe and Japan, it’s imminent or ongoing right now. It seems like a certain percentage of the test will come back positive. And those obvious will, those canines will require a treatment. And that brings you into the monitoring aspect. Now I know there was a paper back by Dr. Bose and Robles about monitoring about a year ago. What is the procedure? Would the vets have to use that off-label to monitor and it seems like those tests would be rather sticky and that they would be regular over what's very relative short timeframes in order to monitor the progress of the treatment. Could you comment on that?

Yes. Absolutely. I’ll comment firstly then ask Gael to comment on where we are on the monitoring side. But yes. So it would be the same test, and whether it’s off label or on label depends on, obviously, if there’s a publication showing it. And it would been, something which you’d probably do at least once or twice, every month or two, when the animal is in relapse. So, it’s something which could be 10 or 20 tests per animal instead of just the ones for screening. So, it’s something which is a huge potential market. If there’s 6 million dogs in the U.S., that get cancer every year, if you do 5 or 10 tests per dog, on the monitoring side, that’s a huge total addressable market and something, which obviously would be a huge market. Someone else on the call comment want to comment exactly where we are with the monitoring?

Yes. I’m happy, Cameron, to add a little bit of color. So yes, we are working on the monitoring claim, if you will. What we wanted to avoid is as we’re launching screening to add another indication at the same time. So our key focus has been on screening initially, and we started discussion with our partners now to add the additional use. So it won’t be, as you mentioned, off-label. It will be something that we back. We just want to make sure as we’re indicating the market we don’t create confusion so we’re sticking to screening for now and next later this year, early next, we’ll launch the monitoring.

If we could just switch over to sepsis, it seems like you have a slew of papers coming forward with all this data coming through, but it seems like the tip of the spear of this expected series of sepsis studies is Dr. Retter’s clinical study that he did mention has been submitted. Could you get a little more granular about that? Because that seems like it will be the first paper data point that we’ll hear about?

Andy, do you want to discuss what data points most likely in the timing from what shall I [indiscernible].

I can answer that. I think the 2 retrospective studies will publish first. I’ve seen data already from both of those. We will write them up and submit them to publication. And hopefully, they’ll be that data will be in the public by the end of this year, by end of Q4. The study at St. Thomas’ will finish recruiting in May, June 2025. So I wouldn’t expect, we won’t publish data from that for a little while afterwards. But we have we’ve got 5 studies ongoing at the moment, and 2 or 3 should report out before then. I hope that answers your question. We do have data that we are allowed to share in our confidential data room as well, understanding the data analysis and the analysis, we understand the data better and can provide a richer picture of the results.

And, Steven, I think it’s probably important to say just at this point as well. So we obviously have invested a lot over the last 6 months, 8 months to get a lot of data. Andy’s gone through the trials, and they’ll be ready in the data room starting from next month, hopefully, and some very large ones, which have already been run, and the prospective ones, in a month for our own internal and sometime next year, but a huge amount of data coming very soon. And that was something very important to us. We wanted to make sure we, did the effort to make sure we had the very large amount of data that we think is needed to get a good licensee interested in licensing in one of the big diagnosing companies to really launch as quickly as possible. And we’ve backed ourselves to get that done, and we’re very close to getting that done now. So I think the team I’d like to congratulate everyone in the Volition team that worked, tremendously hard over the last few quarters to get all the Capture-PCR data ready, get all the sepsis data ready, work with the teams in Taiwan and Lyon on getting all the lung data ready. And there’s a huge avalanche of it coming now starting in the next few weeks, and it will go all the way through the year. So, and I think that will be crucial in the very large licensing deal as we expect to happen now.

Just one last question on the cost cutting. I mentioned that at the last conference call. It was obvious in the fourth quarter that some of costs had been declining. And I’m just looking at the financial statements now. And it looks like at least 25% of the 10 million goal has been achieved. But there’s always a lag in cost cutting. And I’m just wondering when these things have been implemented, especially the executives taking some of their fees in stock. When was that implemented? And do you have a sort of a guideline of how much you’ve accomplished in the cost cutting so far?

Terig, would you want to take that?

Yes, sure. So most of the 10 million will come in the balance of the year or rather the run rate will reduce over the balance of the year. So our intention is to get to point where going into next year where we’ll have $10 million less in expenditure from an OpEx point of view. But obviously that’s going to take time to come and we have already made a good start, but it’s from the second quarter rather than the first quarter. Savings that you might see in the first quarter were actually from a previously announced round of savings that we made. If you recall, we mentioned that back in Q3. So you should see a continuation of that reduction through the balance of the year. The main savings will start this quarter and then will continue until we’re on a run rate which is about $10 million less by the end of the year. Does that answer your question, Steven?

And to be clear, Steven, the run rate to the changes we announced the last lot of, was $2 million or just a little around that. This is an addition, there’s a $10 million addition to that. So it’s not 10 in total, but, this is a new $10 million we’re doing now. And the reductions seen in our salaries to switching to equity, will be starting this month and next month, and throughout the end of the year or for at least six months. So, they’re starting right now, and then it’ll be a strong process through the end of the year to get to where we need to get to. But this $10 million is in addition to the ones we announced before, just to be clear.

Yes. Thank you. That’s more information than I expected.

Excellent. Thanks for your time.

Our next question comes from Richard Deutsch of Sutter Securities.

Yes. Thank you for taking my call and for doing such important work in what would be two very exciting companies if they were separated. Just a question, you’re placing your cancer tests in the veterinary offices and in the laboratory. Are there any other venues such as pet grooming franchises where these tests could be located and produce extra revenue for those businesses?

Gael, do you want to touch that?

Yes. So for now, we are really focusing on the large vet reference labs and point of care, but we have no plan at this stage to expand beyond. As we scale, that’s something we might look into, but not for now.

And I think that’s exactly right. But I’d just like to say what the fantastic thing with our platform is it can be done on a small machine like the Antech machine. It can be done in a lab. It can be done on a lateral flow. It can be done on a very large auto analyzer. So that’s the fantastic thing in the variability of our platform, which gives us tremendous strength. And they each have a very important use, as you said, at different areas and different locations. And we have developed it now on the microtiter plates on the [I-10], which is now part of PerkinElmer, also, the Antech machine, and also, we’re working on lateral flow. And so it’s, and all the large auto analyzers the big companies have when we’re doing the licensing deals, for example, in sepsis, and coagulation, they should be able to adapt to all their machines as well. So it’s amazingly adaptable going forward.

Ladies and gentlemen, we have reached the end of our question-and-answer session. I will now hand over to Cameron Reynolds for closing remarks.

Thank you everyone for joining us today. It’s obviously a very critical time for us now that we have a very wide range of technologies and products we’re commercializing. And it should be a very interesting back end of the year, particularly with the ongoing data rooms and licensing discussions in both the human cancer and sepsis space, and of course, with the deals we have just signed in the veterinary space. So it should be a very, very important and exciting end of the year. And thank you again for your interest in Volition.

Bye. Thank you. Ladies and gentlemen, that concludes today’s event. Thank you for attending and you may now disconnect your line.

Thanks very much, Judith. Thank you.