VolitionRX - Q4 2023

Transcript

Operator (participant)

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited's fourth quarter and full year 2023 earnings conference call. During today's presentations, all parties will be in a listen-only mode. Following the presentation, the conference call will be open for questions. If you have a question, please press the star key followed by the number one on your touchtone phone. If you would like to withdraw your question, please press the star key followed by the number two. If you are using speaker equipment, please lift the handset before making your selections. 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.

Louise Batchelor (Group Chief Marketing and Communications Officer)

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, Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary subsidiary, and Dr. Andrew Retter, currently Medical Consultant to Volition, but has recently announced due to join Volition in 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?

Cameron Reynolds (President and CEO)

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. I'm delighted to welcome Dr. Andrew Retter to the call to provide an update on the Nu.Q NETs and Capture-PCR. As was announced last week, Andy will be joining Volition as our Chief Medical Officer beginning April 1. Many of you will have heard from Andy previously, but I'd like to formally share his credentials. Dr. Retter 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. Retter is the only consultant in the U.K. to hold dual entry on the specialist register in intensive care and in hematology, and provides national guidance on the management of complex hematology patients in critical care. He will continue his clinical and research duties at Guy's and St Thomas' NHS Foundation Trust after joining Volition. Dr. Retter has worked with Volition in an advisory capacity since January of 2022 to help guide the product development and clinical utility of Nu.Q NETs, our CE-marked routine blood test to detect diseases 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 Terig for our financial report. Terig?

Terig Hughes (CFO)

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 and 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 Fuji Vet, 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. Revenue for 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 and development expenditures, mainly reflecting the costs of our U.S. clinical trials, which added $3.1 million to the P&L costs in 2023. To date, various European funding bodies, and in particular Belgian agencies, have committed to the company over $21 million in non-dilutive funding in various forms, including cash grants and loans on favorable terms.

In the fourth quarter, a Walloon institutional fund and regional government bodies of the Walloon Region of Belgium committed additional funding to the company, aggregating approximately $5.5 million, of which approximately one half was in the form of a loan. We would like to publicly thank the various government agencies of Belgium for their continued support. We have also initiated efforts with respect to seeking non-dilutive funding in the U.S. Our aim is to fund some of our major programs through either non-dilutive or project financing, which we anticipate could be substantial over the next two years. As mentioned earlier, at the end of the fourth quarter, we received $13 million in milestone payments from Heska Corporation, now an Antech company and part of Mars Petcare, one of the largest pet health companies in the world.

To recap, we ended the year with cash and cash equivalents of $20.7 million. With that said, I believe that we are well-placed to execute the plans the team have in place for 2024. With that, I will pass over to Dr. Tom Butera, CEO of our Volition Veterinary subsidiary. Tom?

Tom Butera (CEO)

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 screening 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 and 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 and part of Mars Petcare, another leading veterinary company, in completing the exciting tech transfer onto the Heska Element i+ in-house diagnostic platform. More recently, as you will have seen in an announcement just last week, we have signed a supply agreement with Fujifilm Vet Systems for our Nu.Q Vet Cancer Test in Japan.

Indeed, I have pre-recorded my update for today's call as I am currently over in Japan with our colleagues from Fuji, and wow, what an incredible event this last week! We were delighted to be deeply engaged with our Fuji colleagues at their veterinary booth, located at the World Veterinary Cancer Congress in Tokyo. This event also provided a significant exposure to numerous veterinary cancer specialists from around the world. We believe that Japan is a considerable market opportunity for Volition as we seek to expand our Nu.Q Vet Cancer Test offering in Asia, and Fuji is a great partner with us. Fujifilm Vet Systems is Japan's leading veterinary diagnostic laboratory service, with a network of 10 laboratories, serving more than 90% of the 12,000 veterinary clinics and hospitals nationwide in Japan.

As a reminder, our test is a simple, affordable, easy-to-use blood screening test that can be easily integrated into preventive care programs and used alongside other routine blood work during regular wellness visits. We had an incredibly busy time at the Fuji booth and have been excited not only to see the response to the test, but also to hear about the exciting marketing plans Fuji has in place to drive the adoption of Nu.Q. Heather also had the privilege of presenting a poster about the Nu.Q Vet Cancer Test at the Congress. It's been a busy few days, and we look forward to working alongside Fujifilm Vet Systems as they roll out our test countrywide across their extensive diagnostic laboratory network. We are also incredibly excited that the Nu.Q Vet Cancer Test will soon be available as an in-house diagnostic via Heska, an Antech company.

We understand pre-orders are currently being processed, and the tests will be rolled out fully at their upcoming national sales meeting at the end of this month. Soon, veterinarians will have accurate in-hospital, fast test results in under 8 minutes, so that they can discuss findings with pet owners and hopefully develop an action plan before the patient even goes home. Antech is initially pricing the test at $35 to the veterinarian, and we really believe that the relatively low cost, combined with the effectiveness of our test, will help drive adoption of the test, not only as a screening test, but also in time as an important monitoring tool for disease progression and remission. So to quote Cameron, "Very exciting times indeed." That's a quick update from me, given our packed agenda today.

I will now, with absolute great pleasure, hand over to our incoming Chief Medical Officer, Dr. Andrew Retter. Andy is a fabulous addition to our leadership team. Andy, over to you for an update on Nu.Q NETs.

Andrew Retter (Medical Consultant)

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 the delivery of our mission and purpose in the years to come. We really hope to have an impact and 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 NETs and our new breakthrough cancer detection method, which we now call Capture-PCR. So first, starting with Nu.Q NETs and sepsis.

Sepsis, as you've heard me say before, is one of the leading causes of death worldwide, with almost 50 million cases annually and around 11 million deaths. Volition has 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 2 days, focused exclusively on sepsis and the potential role of Nu.Q NETs. It was 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 NETs and have first-hand experience using the assay now. The sense from the group was that Nu.Q NETs 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 peer review and publication in a journal towards the end of the year. Continuing in the theme of publications, shortly after our key opinion leader event and subsequent quarter end in October, the first clinical paper from our Clinical Excellence Group was published. Professor Guillaume Monneret's team in Lyon published data demonstrating the correlation of the Nu.Q NETs level and sepsis. There is a clear mortality signal. What does that mean? The higher a patient's Nu.Q NETs level, unfortunately, the more likely they are to die. We've also seen in a longitudinal fashion that the Nu.Q NETs level tracks very well with the severity of a patient's illness.

We've been using something called the SOFA score, the Sequential Organ Failure Assessment score, to calibrate and check Nu.Q NETs levels. It's brilliant that we've got the first paper out, and I'm really looking forward to publishing and sharing with you more data from our Centers of Excellence as we go through 2024 and 2025. Over in the U.S., I'm pleased to report that Volition completed the Q-Sub process with the U.S. Food and Drug Administration. The FDA have confirmed that we can continue to follow a traditional 510(k) pathway. I'm also delighted to confirm that my own hospital, Guy's and St Thomas', has started using Nu.Q NETs in our first study. In a similar theme, we're trying to identify and track patients and monitor the severity of sepsis. This is a large study.

We're aiming to enroll around 500 patients and compare patients with sepsis to healthy patients undergoing cardiac surgery. This should give us really good data to try and split the patients apart and understand differences between them. For those that might have missed the recent Edison webinar on sepsis, or indeed, their thematic report, I wanted to highlight a couple of ongoing studies, which we hope will continue to reinforce and strengthen our clinical utility case. We have ongoing analysis of two large retrospective sepsis cohorts in Europe. The first is with the German Sepsis Group, and the second is with the team at Amsterdam UMC. In total, these studies will examine the outcome and trajectory of over 2,500 patients with sepsis. They involve the processing of over 8,000 Nu.Q NETs samples.

It's an unbelievably rich data source for us, and we're really excited about this data. We're really excited about presenting it and submitting it for publication by the end of 2024. These studies will be a rich source of insight. They're using Nu.Q NETs on a really large scale, which should enable us to sharpen and improve it as we move forward to, again, bringing it into the clinical arena. Our project with key opinion leader, Professor Djillali Annane in France, is progressing really well. Djillali Annane is involved in a consortium project with an ongoing prospective study, of which Volition is a member. Again, it's longitudinal in nature and large scale and is aiming to recruit 1,500 patients. We've also extended our study with DXOCRO in the U.S.

We have refocused this study to concentrate on the sickest patients admitted from the emergency room, rather than simply including intensive care patients. This is expanding the population of patients in which we're using Nu.Q, and that's really exciting. We hope to close out the study by the end of the second quarter, and we'll share the results as soon as we can. We're confident that we will have significantly strengthened our data within the confidential data room to support ongoing commercial discussions by the middle of the year. From a publication perspective, all eyes and our focus will be on the European Society of Intensive Care meeting in October later this year. We anticipate a number of the studies I've just mentioned will report at ESICM. We're also really proud to be sponsoring our first satellite symposium session at the Congress.

More details will follow, but it's going to be a really busy year ahead for Nu.Q NETs and sepsis. I'd now like to take just a few minutes to discuss Volition's potentially breakthrough cancer detection method, which we first presented at the European Society of Medical Oncology Congress in 2023. Cancer, as we all know, affects the lives of millions around the world each year. Unfortunately, the number of new cases of cancer diagnosed each year is continuing to grow. Like many diseases, early diagnosis, when the cancer is smaller and hasn't spread, leads to a better outcome for patients. That's less surgery, less chemotherapy, and just leads to better and improved outcomes. Sadly, cancer is often a silent disease. It's asymptomatic, and people don't realize they have it until really quite late.

In the U.K., we're a perfect example of that, where around 45% of cancers are diagnosed at the later stages, stage three and stage four. Our test focuses around detecting circulating tumor DNA, ctDNA. Detecting ctDNA is really difficult because the levels of DNA in blood are relatively low, and circulating tumor DNA comprises only about 0.01% of the circulating cell-free DNA. Well, the challenge is compounded as most of the cancer DNA looks almost identical, or is indeed exactly the same as normal DNA. Volition has developed a novel method of liquid biopsy, involving the first reported physical isolation of tumor-derived DNA fragments from blood. The cancer-derived circulating tumor DNA fragments are then extracted after removal of all normal background DNA, and then they are sequenced using a low-cost PCR test. We're calling this technique Capture-PCR.

Volition's proof of concept data was presented at ESMO 2023, demonstrating the isolation of tumor-derived ctDNA fragments from plasma. Volition tested the new method in a small clinical experiment and detected a range of liquid and solid organ cancers, including early-stage disease, stage one disease. These early assays were developed from our initial leukemias model, but to our surprise, we were also able to detect many other cancers. In particular, we were able to detect colorectal cancer. We're really excited about the potential for Capture-PCR going forward. My colleague, Dr. Jake Micallef, and team have presented at a number of cancer-specific conferences, such as the Prostate Cancer and Liver Cancer conferences. They have been sharing their data with important key opinion leaders, and we've received really valuable feedback and positive feedback as we go forward.

The team have also continued to identify other potential markers and other potential targets associated with the PCR test, and we very much look forward to sharing this data, in particular, in solid organ cancers throughout this year and beyond. Last, but certainly by no means least, Jake is working hard on completing the manuscript to submit this breakthrough method for peer review and publication. This is going to be an incredibly important paper, and is intrinsically aligned with Volition's core ethos and purpose of bringing a low-cost diagnostic test to millions of people around the world. Understandably, there will be ongoing commercial discussions throughout the year.

In drawing to a close, and so I can hand back over to Cameron, I'd just like to take a moment, and I hope it's come across from me talking here, to express how personally excited I am to be joining the company. I really believe in Volition's ethos and purpose, and I'll hand you back to Cameron for his closing remarks. Thank you ever so much.

Cameron Reynolds (President and CEO)

Thanks very much, Andy, for providing those insights, and thanks, as always, to Terig 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. Looking just around the corner, the Nu.Q Vet Cancer Test will soon be available as an in-house diagnostic test through Heska, an 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 NETs 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 and be as profitable as early as 2025. And finally, I'm absolutely also delighted with our potential breakthrough CTCF cancer detection method, Capture-PCR, which we had a poster in the fourth quarter at ESMO. We believe this is a true breakthrough moment, the first reported physical isolation of a class of tumor-derived cell-free DNA fragments from blood. We expect that this method obviates expensive and time-consuming DNA sequencing and bioinformatics, allowing for a rapid, cost-effective detection in a routine blood test. This method could become a must-have technology.

Given its significance, we are very much open to licensing this technology. We have been tremendously encouraged by the level of interest thus far. It has been, and will continue to be, a busy few months ahead of discussions and negotiations, not only now on Capture-PCR, but as we build out the data room for Nu.Q NETs through the second quarter of this year, we anticipate more active discussions on that front as well. It is an exciting time for us as a company, and we look forward to sharing further updates and milestones with you over the coming quarters as we continue to adapt to changing times and conditions, deliver on what we believe to be revolutionary technologies.

Given the current macroeconomic conditions, we are focusing on getting each pillar to support itself, either through product revenues, milestone payments, outlicensing, and/or other non-dilutive funding in the coming year. We are making every attempt to ensure as little dilution as possible to reach breakeven as a company with a mix of non-dilutive funding, revenue, and milestone payments from outlicensing as we have achieved in vet. As we've described before, we are currently targeting the following. Firstly, we expect Nu.Q Vet to be overall cash positive from existing milestone payments and the expected revenue ramp as more partners launch and existing partners expand into new territories. We're also working on a range of new products to drive revenue growth and hopefully new outlicensing and milestone payments in future years from vet.

Secondly, we expect Nu.Q Discover to more than double revenue in 2024, and to become profitable as a unit starting in 2025, with over $1 million in the current pipeline and growing strongly. Thirdly, we have begun a strategy to fund, as Terig alluded to earlier, our Nu.Q NETs pillar through non-dilutive and/or project funding with an aim of $25 million. We have targeted a range of governmental agencies and are also preparing the background work aimed at attracting a large player to either outlicense or invest in this product directly. We have made strong progress through the first quarter of 2024 in getting the data required, and our aim is to get the first payments in the next 12 months from either corporate or governmental sources.

Lastly, as discussed by Gael Forterre, our Chief Commercialization 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 large companies as a commercial undertaking of this size is likely beyond our current capabilities. If successful, we believe this strategy could provide us with ongoing royalties and very meaningful milestone payments in the next 12 months.

In drawing to a close, I would like to thank you all for joining the call today. We very much appreciate it, given how much there is to digest across all of our pillars. We are now happy to answer questions. Operator?

Operator (participant)

Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue, and for a participant choosing speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Tim Moore with EF Hutton. Please proceed.

Tim Moore (Senior Equity Research Analyst and Managing Director)

Oh, thank you. That was very informative, prepared remarks, and it was nice to hear that there's a lot of different levers being pulled and good optionality. Maybe I just want to thank you. Sure. Maybe I just want to start out with IDEXX. You know, you mentioned there were revenues, it sounds like the end of the year that started to come through. You know, I'm just kind of wondering if you can talk a little bit about, you know, 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, you know, is it something like $10 per kit you're getting on those because you're assembling the full kit and shipping them?

Cameron Reynolds (President and CEO)

Yes, yes, it is. That's, that's correct. So, yeah, IDEXX have been great partners for the last year and a half, and I think they've been putting a lot of work in to really try to get the sales growing. So I think it's a... 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, yeah, as it was mentioned several times, so 58,000 tests this last year sold, so we sold the components for. So, it 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 yeah, and $10 a test is correct.

Tim Moore (Senior Equity Research Analyst and Managing Director)

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

Cameron Reynolds (President and CEO)

Yeah, 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 vet 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 hear that enthusiasm coming through and have a good new market. Yes, so the feline side, we've been doing some work on as with a range of other products looking to launch in the vet space.

We're looking to get it working in cats this 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 yeah, it's definitely still in process, and it's a reasonable thing to still have on the books.

Tim Moore (Senior Equity Research Analyst and Managing Director)

Great. Great. 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, the 510(k) regulatory pathway. And if you can remind me, you're trying to demonstrate substantially equivalent performance and characteristics of a device already the FDA cleared in the U.S. right? Can you kind of walk us through that? And, you know, I know it's theoretical, but, you know, what is the timeline? You know, I get a lot of questions from investors about, you know, when do you think, you know, if it does work out and you get approved, when do you think you can maybe start achieving revenues on the sepsis side?

Cameron Reynolds (President and CEO)

Yeah, 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, well, publications have shown this closely correlated with intensive care mortality and SOFA score, which is obviously both of which are incredibly important. As we talked about, sorry, I've got a, a cold at the moment. 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-3 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) path? Probably best to 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 predicates in our product, 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, so to go through the predicates as they were discussed. But no, it's something we're incredibly excited about, and I think it's if it continues to go well, and every bit of data we've seen so far has been outstanding.

And, because the test is low cost, can be run on any platform, it could be a bedside test, it can be a lab test, it could be a lateral flow test, and doing it through a 510(k), which is, as you know, is the easier path through the FDA, is very important. Now, as for timing, obviously we're doing everything we can to preserve cash. So we're working with large governmental agencies to see if they can take a large part of the funding in the U.S. as well as Europe. We're also getting the data room ready so that we can get industry partners involved.

So, as I said, that's coming to a head in June, when we'll start open up a data room, to look to get as much funded, as possible from, outside sources. For obvious reasons, the markets, is what it is at the moment, so we're doing everything we can not to, not to spend money. And after that, our product will be at least a couple of years. But don't forget, our model has always been to make as much money as we can, from licensing and upfront and milestone payments. In the last two years, we've got $23 million just from, Heska alone, which is obviously very, very meaningful in what we do.

So I wouldn't just think of it as revenue, which is obviously a few years away, but as we have in vet, getting large chunks of money in the meantime from large industry partners and/or government agencies. And I think there's certainly our aim, and I think it's a very reasonable chance, that we'll get some licensing or milestone revenues from either or both the transcription factors and the sepsis side in the next 12 months. And if you look at the level of payments we've got on the vet side, it's a very important test in the vet, but I think the Nu.Q NETs test is a whole level of importance for humanity, so we'd be expecting some very significant payments in that sort of timescale. Does that answer your question?

Tim Moore (Senior Equity Research Analyst and Managing Director)

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

Cameron Reynolds (President and CEO)

Yeah, 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 a 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 in 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 divest it itself, and I think that's something which could well happen in vet 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 gonna be a very attractive one. But we wanna get that value curve kind of pushed up the curve by predicting felines and/or sepsis and/or transcription factors in the next 12 months. So it's probably a 2-year target for that.

Tim Moore (Senior Equity Research Analyst and Managing Director)

That's terrific, and thanks so much. That's it for my questions.

Cameron Reynolds (President and CEO)

Thank you. Thanks for your time, Tim.

Operator (participant)

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

Ilya Zubkov (Senior Equity Research Analyst)

Good morning, and congrats for the progress in Q4. I have a question on the oncology tests. Talking about Capture PCR technology-

Cameron Reynolds (President and CEO)

Yeah.

Ilya Zubkov (Senior Equity Research Analyst)

What types of cancer are currently considered as the most promising for detection, according to studies and your expectation?

Cameron Reynolds (President and CEO)

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 gonna be low cost, very easy to run, as easy to run as a COVID test, in blood. But certainly potential for every single type of cancer.

You would probably not develop the test for every single type of cancer. You'd probably develop the top five or seven types, which between them account for the vast majority of cancer cases.

Ilya Zubkov (Senior Equity Research Analyst)

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

Cameron Reynolds (President and CEO)

Do you mean in solid tumors with Capture-PCR?

Ilya Zubkov (Senior Equity Research Analyst)

Yeah.

Cameron Reynolds (President and CEO)

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 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 the 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 it's a complete breakthrough, and if we continue to show selection or concentration of tumor-derived DNA, it's gonna 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 level of interest from a range of different groups, and those active discussions are going on as well. We'd expect to have some news on that in the coming months and quarters as well. Because, again, we wanna 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 next few quarters.

Louise Batchelor (Group Chief Marketing and Communications Officer)

Yeah, and Cam, if I-

Cameron Reynolds (President and CEO)

Please.

Louise Batchelor (Group Chief Marketing and Communications Officer)

If I can just add, this is Louise Batchelor here. If 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 CTCF Capture-PCR technology. And we've then got breast and CRC to come, in this second quarter. So there has been some additional data presented, and then we've got some stuff, as Cameron says, further down the line, with the generation two.

Ilya Zubkov (Senior Equity Research Analyst)

Great. Thank you so much. I pass the line.

Cameron Reynolds (President and CEO)

Thank you. Have a great day.

Operator (participant)

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

Bruce Jackson (Senior Analyst)

Hi, good morning, and thanks for taking my questions.

Cameron Reynolds (President and CEO)

Hi, Bruce.

Bruce Jackson (Senior Analyst)

My first question is for Andrew. With the 500-patient study that you've just initiated, could that be ready in time for the conference in October?

Cameron Reynolds (President and CEO)

I'm sorry, Andy's actually not the right answer your question at the moment. He's in clinic.

Louise Batchelor (Group Chief Marketing and Communications Officer)

Oh, oh,

Cameron Reynolds (President and CEO)

Yeah.

Louise Batchelor (Group Chief Marketing and Communications Officer)

No, he's just been pulled into clinic. The full study won't have been finished, Bruce, by October of this year, but we are hoping that we might potentially have some interim analysis available. But we will have the results from several large-scale studies that will be presented at the October conference. So the Amsterdam UMC study and also the German Sepsis Group study will be presented in October. But potentially there might just be an interim analysis of hepatitis.

Cameron Reynolds (President and CEO)

His one is a prospective, Bruce, so the retrospective ones, UMC Amsterdam and the German study, will be presented, we believe, but not the prospective. That will be a bit slower, of course.

Bruce Jackson (Senior Analyst)

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

Cameron Reynolds (President and CEO)

Terig?

Terig Hughes (CFO)

Yeah, good question. Hi, Bruce. So, as we mentioned just now, we ended the year with cash of about $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 our 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 a 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 non-dilutive 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 deals 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, yeah, 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.

Bruce Jackson (Senior Analyst)

Okay, great. That's it for me. Thank you very much.

Cameron Reynolds (President and CEO)

Thank you.

Operator (participant)

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

Steven Ralston (Director of Research and Senior Analyst)

Good morning or evening.

Cameron Reynolds (President and CEO)

Good morning.

Steven Ralston (Director of Research and Senior Analyst)

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've 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 know, you have product categories, well, product and service, listed, and the revenue streams are in the vet and ser- and discover areas.

Cameron Reynolds (President and CEO)

Yep.

Steven Ralston (Director of Research and Senior Analyst)

Could you delineate those a little better so I can better model the company?

Cameron Reynolds (President and CEO)

Terig?

Terig Hughes (CFO)

Yeah, sure. So, in terms of our vet revenue, we achieved about $475,000 of vet revenue last year. That was up 194%. And, that has not yet ramped, 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, you know, 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. That's a bit more difficult to forecast quarter to quarter because it's very lumpy in nature, because it's a number of projects of different sizes, and the timing is from one quarter to another, difficult to estimate. But I do expect to see strong growth over the next year and for the year as a whole. So, yeah, I think we can look forward to further strong growth in the Nu.Q Discover project. Did that answer your question? If you, if you have,

Steven Ralston (Director of Research and Senior Analyst)

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

Terig Hughes (CFO)

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

Steven Ralston (Director of Research and Senior Analyst)

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

Terig Hughes (CFO)

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

Steven Ralston (Director of Research and Senior Analyst)

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 the Vet, and therefore, some minuscule percentage of the deferred revenue should be coming over through the bottom line, well, being put into the top line to come.

Terig Hughes (CFO)

Yeah, that's a good point, and I'm glad you brought that up, because as you know, we've received $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, imminent. And so I do expect to start to see some of that earning this year. But it is a long tail over the lifetime of the agreement, which is 20 years.

Steven Ralston (Director of Research and Senior Analyst)

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. Thank you for your time.

Louise Batchelor (Group Chief Marketing and Communications Officer)

Thank you.

Cameron Reynolds (President and CEO)

Thank you.

Operator (participant)

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.

Cameron Reynolds (President and CEO)

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.

Terig Hughes (CFO)

Thank you.

Operator (participant)

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

Louise Batchelor (Group Chief Marketing and Communications Officer)

Thank you very much, Terig.