Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limited's Full Year 2022 Earnings Conference Call. [Operator Instructions] This conference call is being recorded today, March 16, 2023. I'd now like to turn the conference over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you. And welcome everyone to today’s earnings conference call for VolitionRx Limited. This call will cover Volition's financial and operating results for the full year of 2022, along with a discussion of our recent activities and key upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, President and Group Chief Executive Officer; Mr. Terig Hughes, Group Chief Financial Officer; and Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary subsidiary. Before we begin, I would 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 of these forward-looking statements made during the course of this call. I’d now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thanks, Scott. And thank you everyone for joining Volition's full year 2022 earnings call today. We especially appreciate your time given the busy earnings call season. 2022 was a transformational year for Volition. After 12 years in operation, we have successfully transitioned from a company solely focused on research and development to an organization that has also commercial products. Volition is powered by Nu.Q, our cutting edge Nucleosomics platform, which has enabled the development of all of our product pillars and is the foundation of the company. I am so proud of the hard work, expertise and commitment of our team and what we've achieved together. Given this is our full fiscal year result, we will commence the call with our Group Chief Financial Officer, Terig Hughes, before moving on to Dr. Tom Butera, Chief Executive Officer of Volition Vet. For an update on the rollout of Nu.Q Vet via our global supply and licensing agreements. And finally, I will provide an update on the great progress the team have been making with regards to another one of our key pillars, Nu.Q NET, as well as a brief update on Nu.Q Cancer and Nu.Q Capture. Without further ado I'll hand you across to Terig for the financial report. Terig?

Thanks very much Cameron. And thank you everyone for joining our earnings call today. I will now provide a summary of the key financial results for the year ended December 31, 2022. Starting with cash, we closed out the year with cash and cash equivalents of approximately $10.9 million. From a revenue perspective, we recorded just over $300,000 in earned revenue in 2022, a 240% increase over the prior year, the majority of which was from sales of the Nu.Q Vet Cancer Test with the balance mainly attributable to the Nu.Q Discover program. The net loss during 2022 was $30.6 million versus a $27 million loss for the prior year. This result was predominantly driven by higher personnel costs and sales and marketing spending as we prepared for commercialization. During 2022, we strengthened our balance sheet by adding approximately $6.4 million in net cash before deducting offering expenses through an underwritten public offering of our common stock in August. Furthermore, in August, 2022, we were delighted to announce the award of approximately $1.5 million in non-diluted funding from the Namur Invest Capital Risk in Belgium to fund an early access program for our Nu.Q product portfolio at key sites across the EU, the UK, and the U.S. Additionally, we recorded grant income of $1.2 million in 2022 from the Walloon Region in Belgium. We continue to manage our expenditures and cash flow carefully. And whilst the overall level of expenditure increased in 2022 as compared to 2021, the impact on cash flow was more than offset by receipt of the Heska milestone payment of $10 million in March, 2022. As a result, net cash used in operating activities was $15.3 million for the full year or a monthly average of approximately $1.3 million. In the most recent quarter ended December…

Thanks very much, Terig, and good morning everybody. 2022 was a breakthrough year, and I feel really proud of all the team’s achievements. It seems just a while ago now, but looking back to the first quarter of 2022, we signed our first large scale licensing and supply agreement with the Heska Corporation. The Heska agreement provides three new specific areas that you should all be aware of. First of all, exclusive rights to Heska to sell Volition’s Nu.Q Vet Cancer Test for companion in animals at the point of care. Number two, non-exclusive rights to Heska to sell the Nu.Q Vet Cancer Test for companion animals via Heska’s reference laboratories. And three, certain rights of negotiation to Heska to potentially commercialize a wider test menu for companion animals again at the point of care. The Heska agreement also came with some very significant financial milestones to give you the breakdown. First of all, Volition received a $10 million upfront payment on signing the agreement, and Volition will receive up to $18 million based upon the achievement of near and mid-term milestones. $13 million of which we anticipate receiving in the first half of 2023. In addition to these milestone payments, and most likely significantly greater than these payments is the ongoing revenue that Volition expects to receive in relation to payment for kits for the reference lab market, and for the supply of key components for the exclusive point of care product that Heska will bring to the market. You must all remember every time Heska sells a test, Volition will make money be that through the sale of a kit or from the sale of a key component. It’s a long-term deal, and we believe that it’s a fantastic market opportunity for us. And to bring folks right…

Thanks Tom, and thank you, Terig for those comprehensive updates. Great progress indeed. From a commercial perspective, I would have to say signing the licensing supply agreement with Heska and IDEXX were standout moments of 2022 for me. But in the background, we have not only continued to strengthen our broad IP portfolio, which is a real asset for the company but we've also dedicated considerable time and resources to scaling up and strengthening our infrastructure for delivering high quality services under our licensing and supply agreement. During 2022 in particular we sought to build out HR, IT, finance, legal and commercial functions to support the growing needs of the company. We now have over 100 staff worldwide based in Belgium, the UK, the U.S. and Singapore all of whom play a part in our future success. I will wrap-up the call today with updates on several of our other product pillars. Nu.Q Capture, Nu.Q Cancer and Nu.Q NETs. Human blood is a mixture of many different cell types floating in a complex soup of proteins and other molecules, including nucleosomes released by cells from all around the body. Detecting a handful of cancerous or other abnormal cells in a patient's blood sample has historically been like finding a proverbial needle in a haystack. Volition's Nu.Q Capture program has several strands of technology which one, essentially removes background noise, thereby amplifying the signal; or two, looks to identify the signal in a novel way including through mass spectrometry; or three, isolate various chromatin fragments, including nucleosomes and transcription factors; for analysis by mass spectrometry and next-generation DNA sequencing. I am very happy to report we have made real progress on a number of these trends throughout 2022 and into 2023. As a reminder, this sample enrichment tool removes healthy nucleosomes,…

Thank you. [Operator Instructions] Thank you. And our first question comes from the line of Bruce Jackson with Benchmark. Please proceed with your question.

Hi, good morning and thanks for taking my questions. A two-part question here on the milestone payment mechanics. So do you plan to receive the full $13.5 million as a lump sum payment, and then does that get accounted for as deferred revenue? And then does it come back into the income statement over time?

I’ll pass it over to Terig to answer the question? Hi, Bruce. Terig?

Hi, Bruce. At this point we are expecting to receive the $13 million, the next $13 million. We’re expecting, it’s actually two separate milestones of $6.5 million each. And the first one is on the commercial launch of the point of care for it, as a screening test. And the second one is for the first commercial sale as a monitoring test. We are expecting to get both of those within the first half of this year. In terms of the accounting for that, it will initially be treated as a deferred revenue under the accounting rules and will be allocated along with the $10 million milestone payment that we received last year over the life of the product. So, as we make sales a portion of the deferred revenue will be allocated to each product sale that we make.

Okay, great. And then just one follow-up, if I may. With the remaining $4.5 million is that going to come to you in 2024?

So the remaining $5 million will come to us in 2024 subject to us providing data or the first commercial sale of a cat product. So, we are expecting that in 2024. Can’t tell you exactly when but it’s on track.

Okay. Super. Thank you very much for taking my questions.

Thanks. Have a great day.

The next question is from the line of Constantine Davides with E.F. Hutton. Please proceed with your questions.

Hi, good morning. Just sounds like really good progress, early progress in the commercial front. And I guess just following up on Tom’s comments about receiving orders in 40 states, I was wondering a couple things about that. One is, what’s the profile of some of these early adopters in terms of their practice, just whatever characteristics you can share. And then any kind of early lessons both, positive and negative in terms of how you’re talking to these customers and any tweaks you might have in terms of messaging or promoting the product. Just looking for some color there. Thanks.

Hi, Constantine. It’s Tom. Thanks for the question. Our awareness campaign and education of the veterinarians has been very specific. It’s supposed to be used for wellness preventive care programs, of which close to 50% of the dogs that are presented to the U.S. on an annual basis come in for wellness exams. So these are healthy animals and that’s been, and it’s not supposed to be used for sick animals at this point in time. Of course, it’s also supposed to be predominantly used for dogs seven years of age and older because 50% of dogs that approach the ages of nine, 10 years of age die of cancer. The other small – the other strong target is about 30 predisposed breeds starting at the age of four years of age. So that’s how we have positioned the test. We are gaining data as we submit, as we are testing animals in a large number of diversified practices. They’re predominantly general practices right now because it is a wellness preventive profile. And consequently, those are the hospitals that are using it and using it pretty effectively as far as giving you a more broad spectrum piece of information is to specific hospitals obviously, I can’t do that, but the feedback that we’ve gotten from a general basis is, and the questions that are given to us on Ask [ph] Nu.Q, which is our hotline predominantly come from general practitioners using it in their wellness profile.

Great, thank you. And then just one follow-up. I know you spent some time going over milestones and you did an offering in February and you’ve alluded to clinical trial expenses kind of ramping up this year. Just wondering if you can give us any kind of sense for where we should expect burn to fall this year, particularly as you invest in some of these clinical programs.

Yes, sure. That’s a good question and we do expect that the burn will ramp up a little bit this year, because of the clinical trial costs and clinical trial activities that we’re undertaking. Right now, we’re probably looking at something in the region of $2 million to $2.5 million per month in this quarter. But that will be offset over the course of the year with the milestone payments that we receive. So although we expect, the overall expenditures to go up, we expect that to be mitigated by the $13 million of milestone payments that we will receive in the first half of the year. Does that answer your question?

It does. Thanks. I’ll hop back in the queue.

Great, thanks.

Thank you, Constantine.

Thank you and take care.

Thank you. Our next question is from the line of Steven Ralston with Zacks. Please proceed with your questions.

Good morning or afternoon. I’d like to focus on the near term revenue potential for the canine detection test. First of all concerning the deferred revenues, when you say that it’s going to be allocated over the life of the product, in that lifetime are you assuming that it will be that $1.5 billion opportunity and that you’ll achieve that and it’ll be a percentage of that? Or is there something like a shorter timeframe like expected sales over the next, well, let's say five years or three years?

So the contract that we have with the deferred revenues relate to spreads over approximately 20 years. The way that the accounting rules apply is that we forecast the revenue over the life of the product and then we keep updating those forecasts and allocating the revenue accordingly. It is a bit of a complicated process and a bit of a moving target because as we get better at forecasting the revenues, the amounts that we allocate per product sale will change over the years. So, it’s a bit of an unknown quantity at the moment, but I think the best way to think about it is this will be allocated over quite a long time. It's not going to be over four to five years, it's going to be over something like closer to 20 years.

Alright, thank you. Actually, that's a good news, bad news situation because greater the potential of the product, the smaller the allocation. So in a way you are hoping that you won't be able to quickly monetize those revenues in sales because that means the product would have more potential than you expected.

That's right, Steven. I think the important thing for us is that we get the cash when we get it and we are able to spend that cash and utilize it. And from a discounted cash flow point of view, it's the cash that's important rather than the accounting rules.

And as deferred revenues, is that – when you talk about your cash balance, does that include the deferred revenues?

Yes, that does. The cash balance includes the $10 million that we already received in March last year.

All right. And the paper that we submitted for peer-review, I assume that's the use of the test for monitoring?

That's correct, Steven. It was submitted about a month or two ago, and it's for monitoring for disease progression and remission. And we are currently getting some questions back. It looks very favorable. And we hope to have that publication approved hopefully within the next month or two.

All right. And that's the reason for your target that you expected in the coming weeks. And that would trigger one of those – one of the $6.5 million payments, correct?

That's correct. Absolutely.

And looking into the future, what do you expect the timeline for the feline component of the test? When do you think that that will be start generating sales or being commercialized? Is that 2004 [ph] event?

Yes, 2024 event is when that would probably start. We're going through validation studies right now. We're working through all of that. There is almost a 100 million cats in the United States alone. We're just talking about canines right now. So obviously if we are effective in bringing this to market, this could be a significant opportunity for us. We anticipate hopefully completing our studies on this, hopefully by the end of 2023 and early part in 2024 and having a paper validating our studies hopefully by first half of 2024.

And I'm assuming that the next rev commercialization, revenue stream is going to be from Nu.Q Vet. At least is that what you are anticipating?

Sorry, is that within Nu.Q Vet this will be the next one or the next revenue for the entire company would be this?

Yes, the next revenue commercialization revenue stream after with the initial one being Nu.Q Vet obviously for different animals and you say companion animals, and I assume that even goes up into equines. Then the next grouping would be Nu.Q NET?

That's correct. So we've got the two-pronged strategy in the U.S. which we're in the process, and I think we're reasonably close to applying for breakthrough designation status. We would expect if that – if we do get breakthrough designation status, it's very nice and we would be ready to commercially launch by the end of 2025 in the U.S. If we do not get breakthrough designation status, we're hopeful, but you never know, it would delay it sometime into 2026. But don't forget, we do have a CE Mark on two platforms in Europe now. We've got a lot of key opinion leaders now working on validating the product in their own areas. We would expect potentially some early revenue, small revenue later this year on clinical revenue or milestone revenue in Nu.Q NETs from Europe [indiscernible], but nothing really substantial until next year in Europe. And then, as I said, 2025, if we get breakthrough designation status, or 2026 if we do not. And I think it is going to follow the commercialization path of Nu.Q Vet, low CapEx, low OpEx deals with big companies. We're in very active discussions with a wide range of companies now on adapting Nu.Q NET to their platforms. A handful of multi-billion dollar companies, or larger. So the Nu.Q NET is really taking off on the commercialization side, and that should become a big part of the story later this year and next year.

Thank you for taking my questions.

Thank you, Steven.

Thanks Steven.

Our next question is from the line of David Westenberg with Piper Sandler. Please proceed with your questions.

Hi, thank you for taking my question. And sorry, if I missed this. I'm newer to the Volition story. So, on the point-of-care veterinary Nu.Q test can you remind us again the expected commercialization date on the point-of-care? And what part of it is in your court versus what parts of it are in Heska’s court in terms of the commercialization?

Yes, thank you, David, for the question. It currently is under the end stages of validation in Heska’s court at this point in time. So we are waiting for that, and we're getting closer every day, we are very excited about it at this point in time.

Got you. And then I really liked the way it's positioned on the IDEXX side, as you know, this is one of a series of ancillary tests that be used in a wellness setting. Can you talk about some of the ancillary tests that people use in conjunction with Nu.Q? And can you talk about, is there any opportunity for you to commercialize some of these ancillary tests, maybe in the point of care or any kind of ways to think about that?

Yes, this is another good question, David. Typically with dogs that are seven years of age and older, and this is supported a lot by the AVMA and the veterinary community, they typically come in once or twice a year for what we call a routine chemistry panel. And in that routine chemistry panel, typically CBC and routine chemistries are done. BUN, creatinine, liver enzymes, this type of thing. That, that profile typically will cost a veterinarian excluding the exam, excuse me, a client, somewhere around a couple of hundred dollars if potentially an x-ray is done, it might be a little bit more than that. And if you think about it from that standpoint including our very affordable test into that price structure as part of a cancer screening test, it just fits right in the middle of it, especially for those dogs that are seven years of older, because the veterinarian, when they communicates with a client, is not going to say, we’re, oh yes, we have this other cancer screening test that’s extremely expensive. No, it’s highly affordable, can be delivered by the veterinary technician as well as the doctor. The same scenario, David also applies to the dogs that are four years of age and older. It’s recommendations from the veterinary community right now that you start profiling animals at the age of sometimes three and four years of age. So, you can watch for medical trends. Again, the profile may not be as extensive as it is for the seven year old, but certainly we encourage veterinarians and many veterinary hospitals do that. Again, the Nu.Q Vet Cancer Test can fit right into that, especially with reference to those predisposed breeds. And quite frankly, if you have a Golden Retriever or a Labrador or one of those types of dogs, you’re going, once you start doing it, you’re going to do it more than once a year. You’re probably going to do it biannually, because you really want to know, can I catch this before I start seeing clinical symptoms? So hopefully that answers your question.

Yes, that definitely answered the question. Just on my last one here. Can you talk about the feline product? Is that in the agreements that you – the commercialization partnerships with either Heska or IDEXX would that be separate and if it is separate, what would be your commercialization strategy with that? And thank you very much for the questions.

Yes, David, on that, it’s specifically with reference, that’s the feline lymphoma, and that is with Heska and specifically as a point of care, Heska has an exclusive with us on a point of care with that product. We are – we’re not only going to be studying feline lymphoma, which is the predominant one in cats that veterinarians frequently are having to deal with, but we’re also looking for other additional cancers as well. But feline lymphoma is the specific one that comes up most prevalent, and that’s the one that we’re booked in with in terms of the point of care test, exclusivity with Heska.

And sorry, David, just to clarify one thing as well, just so our business model you asked, I think specifically would we add other things to our panel? Obviously the partners we license to and sell the basic products to exactly what Tom said, but we do not see ourselves running our own lab, having our own sales force or even our own machines. So, we will absolutely be used with other tests, but Volition’s focus is to produce the key components and then prove the product works and then let others do the selling the panels the collecting of the blood that’s in human and in animals. So that keeps our model very low CapEx, low OpEx from our side. So typically that will happen a lot, but it’s not something we will do in that process. So, and that is the model we’ll take through to the human NETosis and human cancer space as we grow. So that we can grow very quickly, and do all the heavy lifting is done by our partners on the commercialization side, if that makes sense as well.

It does. Thank you.

Thank you.

Thank you, David.

Our next question is from the line of Jim Sidoti from Sidoti & Company. Please proceed with your question.

Hi, good morning and thanks again for taking the questions. First one is, you’ve done a – you’ve made a lot of progress so far. You’ve signed up two very large distributors in the vet world, but there’s still a third one out there that I think Tom knows very well. Are you in discussions and could – is it possible we’ll hear something about that in the next 12 months to 18 months?

We are – it’s a very good question. We are in active discussions with a number of big partners that are out there and we are in continued active discussions, and they are active at the present time.

Okay. And then as far as capacity goes, do you have to make any investments to ramp up production to supply these key components? Or do you have the capacity on hand already for that?

A very good question. So we can produce the key components. Obviously the two biggest ones are the antibodies and controls. We mass manufacture the controls now in Belgium at our Silver One facility, which has worked out fantastically well. We are doing some minor expansions in the freeze drying and some other areas, but we tend to get that actually as a support from the Belgium region. But you’re talking hundreds of thousands of dollars. It’s not nothing ever going to be very large. On far as production of the plates we use a group in the U.S. now for our U.S. needs. We – I actually visited them last month and they’re very capable of ramping up at a very high level. So that should not be a problem unless it really, really got very big, very quickly. But we do expect the growth to be steady over this year and through next year, so it should not be a problem. And we are also ramping up some internal capacity in Belgium for any extra capacity on the place. But overall, we think we’re very comfortable. We have the capacity to meet any likely demand and, but we are preparing for the future to make sure that as that demand grows, which we do expect as to strongly grow throughout this year and through the next year, we can meet it.

All right. Thank you.

Thank you.

Our next question is from the line of Ian Cassel with IFCM. Please proceed with your questions.

Yes, I guess my question would be directed towards Tom, the vet opportunity seems really, really enormous when you think about just the cancer screening now launching in the U.S. and then globally cancer monitoring. It sounds like that should be launching later this year. Same things launching for cats then in 2024. And you mentioned NETosis for Vet and I don't know if that's a 2024 or 2025 type of product but I was wondering if you could kind of explain Tom, like what that real – what that test really is and how it could be applied at the GP office?

Yes. Certainly and thanks for the question Ian. First of all, we are currently starting – we are starting our studies in NETosis this year in 2023. We anticipate hopefully having some papers by 2024 and doing some presentations on it, the various conferences probably throughout the world. To speak a little bit about NETosis, you have specifically about GP. There's two levels here; the first level the [indiscernible], it's a biomarker that uses our platform to be able to identify non-cancer diseases. In particular diseases such as sepsis, thrombosis, pancreatitis, aspiration and pneumonia, these are all diseases that are very common on the human side as well, but they're also very common on the canine – on the animal side. So consequently, those are diseases that we have marked as studying first, so that we can do proof of concept, that we can actually identify this biomarker as a differentiator in those diseases to give the veterinarian, whether it is a GP or a specialty emergency doctor, a key idea as to how sick that animal may be in one of those disease entities that I just mentioned to you. So an animal that comes in that's sick, vomiting, diarrhea, septic, not feeling well. Before you have to run a whole ton of chemistries, this could be the initial biomarker that that GP late in the afternoon and takes on that animal to give an indication whether to go to emergency, whether it to stay in the hospital or maybe it can go home and come back again the next day for routine treatment. With reference to the specialty in emergency hospitals, this is something that's really going to be something very beneficial from a triage situation. These hospitals are over inundated with animals coming in on emergency and…

Maybe the last question I have as well is, there's an area of Vet that, that hasn't been talked about yet that is very significant, and that's on the production animal side. Is there applicability to either the Cancer Screen test or NETosis test kind of hitting that, that large market opportunity as well?

Yes. I would say the answer to that, Ian, is NETosis in particular when we're looking at potentially an equine or potentially a bovine or cattle situation which refers to cattle, which is a multi-billion dollar industry, there's a lot of diseases with reference to metritis or mastitis or respiratory disease. And that really fills into the NETosis type product where you can come in and diagnose and get a strong indication in a herd as to which ones of those animals are ill. So you don't have to treat the entire herd. I mean, you can imagine feline situations, I mean, it could be an immense product. On the equine side, we specifically, we certainly see it for use in disease entities, but the other area where we see it could really be a significant markers from performance standpoint. To really give us a strong indication as to how well that horse is performing or where that horse may need some additional therapeutics. So those are the two areas that we're going to be looking into most likely that, those types of studies will be really stunning to ramp up a little bit latter part of 2023 going into 2024.

Okay. Thank you.

Thank you, Ian.

Thank you, Ian.

Thank you. At this time we are at the end of our question-and-answer session, and I'll hand the floor back to Cameron Reynolds for closing remarks.

Thank you. Before I start the closing remarks, I'll just make one statement. We've been asked a few times whether we had any exposure to Silicon Valley Bank and other market issues with the bank. Short answer is no, we do not. And we are obviously monitoring the situation and like everyone, there's some fluctuations in markets and things going on, but we have no direct exposure to it whatsoever, just to be clear in case anyone asks that in the future. And so thank you very much for the call today. I think it's very clear we are now very much on the commercialization path. We are continuing on with our development and research, but we're really on the front foot now on the vet space and I think on the NETosis space. And we are really following up now on the human cancer space as well. So expect to see a lot of more information throughout the year as the revenue goes up and – as the revenue goes up and really start to show a steady ramp on what we are. And then as we really start to layer in NETosis and some more NETosis deals and revenue as well as the human cancer side we'll have a lot more coming in on as well. So thank you very much. And as a final reminder we have a Capital Market Day, which will be before the next Q, which is on May 11. Around the queue, May 11 in New York City. And yes, again we'd like to thank the New York Stock Exchange for alerting us, use their fantastic facilities, and we'll be making quite a few presentations and developments on all the things which are moving forward so well. So anyone who can make it, please contact us, and it should be yet another great occasion where we can showcase the progress we've made on so many fronts. Thank you very much. I'm really looking forward to updating in the coming months as we continue to develop. Thank you for your time.

This will conclude today's conference. You may disconnect your alliance at this time. Thank you for your participation.