VolitionRx Limited (VNRX) Earnings Call Transcript & Summary
May 11, 2023
Earnings Call Speaker Segments
Nik Wood
attendeeGood afternoon to you all. A very, very warm welcome to Wall Street and a very historic building, the New York Stock Exchange. And a very warm welcome to our webcast our remote virtual audience who are joining us as well, thanks to our camera crew at the back of the room. You're very welcome. This is about the evolution and the developments of Volition, but it's also about you, and it's your chance to ask questions, and very much our remote audience are involved in that as well. And we strongly advise-- only invite you to submit your questions either live here in the audience, but also by investor relations at vilition.com. And we have my colleague, [ Louise here, Lu ], who is going to transmit those questions to me. That's investorrelations@volition.com, and we will be carrying the questions at the end of this session. By means of a brief introduction, and there are some familiar faces in the audience already that I think I may have met last year. My name is Nik Wood. I'm a former BBC Television and Radio journalist, and a newspaper man. Originally based in the U.K., but I joined the BBC business unit, which sent me all around the world. And I'm sad to say that when I came to Wall Street and the stock exchange, the trading floor, where you will join us later really was a trading floor with people actually doing trades instead of computers and algorithms, but it is fantastic to be back. It's also been great in recent years for myself and my colleague to have followed the Vilition’s story, and that really is why we're here today. Obviously, we have investors, we have analysts and there'll be a lot of information for you. And what I like about these sort of presentations is, of course, we like to hear from the Volition people themselves, but we hear from the practitioners. And today, we have practitioners from the human health side and also the veterinary side, who really, as we say, in the U.K., because there is a bit of a coal industry left work at the coal face. These are the people who have to put into action the platforms that we will be talking about today. And they have a wealth of knowledge about how well or otherwise this is going to work in a very changing world. And that really is one of the strengths of today's event. But we need a good warmer artist. So who better than Cameron Reynolds, who is, of course, Group CEO of Volition to get us underway. Cameron, please join us on the stage.
Cameron Reynolds
executiveThank you, everyone. It's great to be here, and it's so great to see so many new faces as well as people who've been following us for a very long time. It's fantastic to be here. Forward-looking statements, and I'll start off with our mission, which is very simple, to save and improve lives of millions of people and animals worldwide and it's been a journey now of 13 years, and I think we've developed a fantastic platform. And now we're really getting to the work where we can help many, many people and animals in their daily lives to have a much better life. So Volition, we do a lot of different things. And you're going to hear today from a range of different people who have really become involved in the company just in the past few years as we get to our products. And so Volition itself, we do all these things on our basic platform, nucleosome quantification, the chromatin fragments, which we measure, let us work in all the different areas. So a lot of people say, how can a company so small, we're just still over 100 people, do so much and so many you got things and so much good in different areas. I think the thing to remember in everything you hear today is all the same platform. And now we're working with great teams in the veterinary space, in the NETosis space to deliver that to patients and people worldwide. Just the 5 pillars themselves. I won't be talking too much about the first few. Today, we're focusing on net invests, but Nu.Q cancer, we're very still active in and we'd expect to have the first products in the next few years, but we're focusing on the other pillars, Nu.Q Discover, which is where we use our platform to help other people. We now have a range of different agreements with some fantastic groups around the world with us using our platform for other things. And you could capture we're developing a more advanced platform for detection of cancer as well. But we'll focus today very much on what's very close to markets, and it is either launched or about to launch in Nu.Q Vet and Nu.Q NETs. And of course, the focus is obvious, that's what we're doing right now and what people want to hear about, but we're very active in all our pillars. So what sets us apart? In this great building, there are a lot of companies, a lot of people do a lot of things. What makes us different? Our tests, I think, quite uniquely a truly simple, low-cost, accessible and routine. What does all that mean? Routine means it can be run in any lab in the world on a lot of different equipment, low cost means the test is below $100 and very affordable and it can come way down and accessible. We're trying to do deals with lots of different people so that our platform, we consider agnostic, meaning we'll work with lots of different groups to make it available on lots of different platforms. What does that mean in practice? Where are we now? If you look at the top left-hand one, that's where we've launched in Nu.Q Vet today, microtiter plate, a great way to start, a great platform. But as you get to more and more tests and we want automation, we're now working on the second one. It's is a product now on the Nu.Q NET side. It works extremely well. That's the i10. -- does about 500 tests a day. So it's a much higher throughput and a bigger machine. The middle one, you'll see a bit later on. We actually have one of them here. That is the product launch for new Nu.Q Vet through Heska. That's a point of care, which means it can be done at your bedside or in this case, the vet hospital in under 10 minutes. So that's very important. And obviously, the Heska relationship is extremely important to us, and that's their machine. The last 2 we're working on and expect to have ready sometime late this year or next year. The 20 minutes is the machine is HIA. This is what a large lab machine looks like then you can cut the test down, hopefully, again to below 10 minutes, and you'll see why later on that's incredibly important in some conditions. And then that would be truly something which can be done as part of ordinary blood work all day every day in the big hospitals. And also very exciting. The last one is at a lateral flow test, probably more familiar with that as a quick test like a pregnancy test or something can be done instantly as a readout, and that readout there can give a quantitative readout. So that's very important. It gives you a number, not just a yes, no. So all of these platforms were developed or developing or close to, but we aim to be agnostic and really make it a big democratic platform worldwide. So these platforms are important. But each one of these can be used in human, in animal, in monitoring and in screening. So this is how the platforms all work together. It's very important also to have good intellectual property. There's no point in developing something fantastic and then having it other people take it from you. We've been very careful and very diligent in doing a lot of intellectual property. We have a very large patent portfolio now and it's growing. I think we completely dominate our space and what we do. So that's another very important part of being successful. So all in all, I think we've got a fantastic team now. You're going to hear from some great new team members who are really helping us to commercialize. And of course, our existing team has been developing the platform worldwide. So I couldn't be happy where we are. Thank you very much for coming.
Nik Wood
attendeeThank you very much, Cameron, for getting us underway. And it's kind of going to be a game of 2 halves, really. The first half is going to be looking at the human health side of things. I mentioned that we'd be hearing from practitioners at the sharp end, and I think most people in this room would agree it doesn't get much sharper than an intensive care award, particularly in recent years when we've had the COVID pandemic. So our first speaker comes from that background. His name is Dr. Andy Retter. He's going to tell you a bit about himself. I'm not allowed to tell you the hospitals that he works in the U.K., but I can tell you they are very famous hospitals and you only have to go on LinkedIn and you'll see it in a couple of seconds. He is a consultant-- he's a national health service doctor, a consultant. He's also a consultant hematologist and what he doesn't know about sepsis really isn't worth knowing. So please, Andy, join us on stage, tell us a bit more about yourself and a bit more about sepsis and also Volition.
Andrew Retter
attendeeThank you very much for that introduction. And thank you. I'm going to skip forward actually. Just to say, these fees that I'm expressing today are my own. I'm not. They don't come from the trust that I work for. And that's just important for lots of reasons, or bureaucratic reasons in the NHS [indiscernible]. I've been working with Volition as a consultant with them for just over a year now, and I'm really excited to share what we've learned and what we hope to learn going forward. And just picking up that last comment, there is an awful lot for us to learn about sepsis and improve outcomes. Sepsis or the derivation of the word sepsis comes from a Greek term, meaning [ by lot ]. And in my day job, I see lots of patients with sepsis, and they die. If you go back to the Lance, well, most modern data is that a patient receptive shock and multiple on failure, about 4 in 10 of those patients, 40% or more will die. And that's despite intensive care trying to learn lots and lots and lots about them over the last 40, 50 years. The current definition of sepsis is sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to an infection. And I'll come back to that at the end because I think it's a really important thing to bear in mind. And the final thing I want to pick up, I clicked on a little bit early, is that yes, I'm an intensive care doctor with a real specialist interest in sepsis. The reason I was recommended to Volition is I'm also a hematologist. And I find hemostasis, the stopping of bleeding really, really fascinating. I have been accused to being a geek before, but that's a problem true. And the cross-link between infection and the hemostatic system is so crucial. And I think what I'm going to try and explain is why I think the Nu.Q test, the 3.1 assay, so critical to improving our understanding there and is potentially transformative. This slide was actually provided by Professor [indiscernible], a world-renowned expert in sepsis. And at the points we're trying to make here, there are over 15 million deaths a year from is there are over 50 million cases, sorry, and over 11 million deaths a year from sepsis. Over 40% of deaths in children under 5 are from sepsis and 50% of survivors are left with long-term Sequala. I chose that term I wrote on the previous slide. You can see this poor lady. She's lost both her legs [indiscernible]. And you can literally see people turn black in front of you. They can deteriorate that quickly. Sepsis is universal, literally from the cradle to the grave. We have neonatal sepsis. We have purple sepsis in post part of moms and then sepsis an older age, you'll all be familiar with COVID and the severe organ value we saw with COVID 2. And just look at it, 100,000 people in the population, there are about 370-plus cases a year. That's more than cancer. That's more on attacks and more on strokes. So whatever health care ATC you look at, be that the World Health Organization, National Institute of Clinical Excellence in the U.K., the CDC in America and the European health care regulatory authorities sepsis is a key priority. But look at this slide that Tejal has produced. Look at the investment in sepsis, a huge burden of disease and less investment there. And we feel there's real potential to improve outcomes here. This is just taking us through the assay and what NET is. And next stands for a Neutrophil Extracellular Trap and this is the condensed chromatin that spewed out behind neutrophil. And you can see the DNA being unspoiled where it's wrapped around these new cases and the red wide are our antibodies picking up those new comes. It's just saying they're attached to magnetic beat here. And that's our proprietary diagnostic [indiscernible]. So the link between calculation hemostasis and the immune system, I put the site in here as a break. I love [indiscernible], and John Cleese is just about to say to everybody, what did the Romans ever do for us? And I think a direct link to me working with elision and being involved in NETosis and studying NeTosis is actually COVID because COVID revolutionized or we really reemphasize to us what we've slightly forgotten about the link between infection, dysregulated response to infection and from this formation. I'll skip past this. So this is a complicated slide, and I'll try and take you through it. So what are we saying here? So let's deal with bleeding, first of all. So if you cut, you'll stop bleeding, your tissue factors exposed and your body stops you bleeding, don't want to bleed to death. We all know about hemophiliacs and the Russian or family, et cetera, when they couldn't stop bleeding. And the doctors are really great at splitting things out because that's an easy way to understand what's happening. But that's not the real world. If you can't, it's most like your cut on I know a piece of paper or someone staffing you or falling over and grazing your hand whilst you're running. And your innate immune system is reached at that point. So there's an immediate link between stopping bleeding and your body and its cellular mechanism signaling, saying, come here and help, it's likely that us my skin has been breached or meet an insistence on breached, and we might be invaded by an organism. And so there's this cross-link and continuous talking between stopping bleeding and signing your immune system. And what we've got here and what we understand here is that net are really key and important part of that bridge. So the out this DNA behind them. Sorry, I don't mean to hit the microphone. And the nets are decorated with proteins that have a huge range of functions they attract other immune cells, come here and help. They actually capture bugs and some bugs are clever enough to manipulate nets to hide them now as well, which is another market that they've got to be important. NET also have something called tissue factor on them, which promotes blood clot formation, which is why you've got a blood clot here, too. What we know is that if you get an excessive NET formation, those NET s can break away begin your circulation and go somewhere distant -- so that circles back to this regulated host immune response. You get excessive activation of your immune system. And if you have free circulating NET s, they can be directly toxic to other tissues, to can damage your heart, your lungs, your kidneys, your liver, your brain, any organ tissue you want. And they're probably part of the key link of explaining why people progress to multiple organ failure as a potential real marker of severity of illness. The other thing is they're associated with blood clots. You can see the cost at the end there with clear these tiny little building blocks, which involved from stopping bleeding and red blood cells are bound together and they can figure excessive blood clots. And if you have small blood costs, former blood vessels that can stop oxygen going downstream. So again, you get more organ failure. So there's really intimate link between stopping bleeding, hemostasis and our immune system and the basic building box of our immune system. And coming back to what Cameron said at the beginning, that's years of research. I've just summarizing a very broad brush there. The reason I'm with Volition is that this is a diagnostic test, which is easy to run, is broadly applicable. It's not a post doctorate in a laboratory in a teaching hospital or a university hospital studying frozen samples retrospectively. This is a widely available, easily reproducible, easily deliverable test, which isn't going to just go into teaching hospitals, it could go everywhere. And you already have reference to the point of care testing down there now it's [indiscernible], but that's potentially extremely deliverable to a huge volume of patients. This is just some real-world data. COVID was pretty scary for all of us. It was pretty scary in the IT. This is an early study. And you can tell we were stressed this is wave 1 because we define how sick patients were by where they were. So the sickest were an ITU less on a normal ward or the floor and then the emergency room here, okay? The sickest patients were an ITU and the sickest patients have the highest nuclear levels died. And we've seen that sort of finding repeatedly. This is another study, which is by one of my colleagues, [indiscernible], who works just down the road for me. And again, the thing to pick up here is the graphs. And again, we're seeing a consistent signal. Those patients with the most severe COVID at the highest levels. So there's an excessive [ immunotobasis ]. And then in the lower graph, you've got a signal to the disease severity. The patients who died, the NET levels stayed persistently high and didn't fall those patients to improve the UQ levels fell. So it looks like we've got a powerful tool for monitoring. Intensive care doctors are obsessed with organ failure. That's what intensive care does. It supports organs being with ventilators, renal replacement therapy, special ventilatory support, cardiac support, et cetera. And so there are lots of organ failure score, and they often come on huge checklists. In America, we tend to talk about the Apache 2 score and the Apache 4 score. In Europe, we tend to use the sequential organ failure assessment score, the safer score. And this paper published by [ Morramon] last year sows that the new key level correlates well with sequential organ failure assessment bluntly, the sicker the higher [indiscernible] -- that potentially provides doctors with really useful and powerful information early. And you heard Cameron talking about the test and the turnaround time, potentially within 45 to 60 minutes, perhaps even faster. And that's a really good marker to identify this is a more poorly. This is a sicker patient you can differentiate your response to. The SOFA school in itself is quite tricky. And just a little cumbersome it slightly bureaucratic, there's lots of bits to check, et cetera. And so we just tend to use it in a research setting more than anything else. One of the things will come across and here repeatedly in our talks is how early diagnosis is so important. I think we're all familiar with the context that tissue is time. And actually, if you delay giving antibiotics, patients will tone severe sepsis, the patient's mortality goes up by over 7% every hour. That's a lot. 45% of them with severe sepsis if they get to ITU will die, there's a huge room for us to potentially improve and change. And I think this test helps us in that process. On the other things we picked out as well is that one of the most common reasons for litigation to be taken against health care organizations, certainly in the U.S., U.K. and in Australia is delayed or failed recognition of sepsis, sending someone home because you didn't think they were too sick, but you just got it wrong. And hopefully, this would be aid, a potential aid to diagnosis. And so yes, I think I've covered this already. It's about producing personalized care and showing that link between the innate system and infection. Just before I hand over to Remi, I'm going to spend a moment on this slide. This isn't some intergalactic blob. This is a neutrophil injecting that promoting there's nucleosomes behind it in next and it's labeled with this blue green fluorescent dye, and that's attached to our antibody. This is showing that our [indiscernible] works, that's actually a NET that you can see there. And so it sort of to me, this is seeing the technology and visualizing it in action in it works. So it's really exciting times and a very grateful opportunity. I'd like to hand over to Remi now who's going to take you through our commercial strategy.
Remi Rabeuf
executiveThank you. So Hi, everyone. So very happy to stand in front of you today. That's my first time in New York and obviously my first time also in the New York Stock Exchange. So Andy, very happy to team up with you. And congratulations for your nice introduction about what NET are, our new unit assay and the underlying technology and some information about the burden of sepsis and some insights on newness and the potential to become a real game changer in the management of sepsis. So the purpose of my presentation today will be to give you some insights on the key components supporting Volition strategy and road map in order to bring our R&D biomarker into real life practice. But before go in more detail, a few words about me. So I'm Remi and French. I live in Grenoble in the outs. I joined Volition in September 2021, so 18 months ago. And I'm very excited and delighted to be -- to contribute to bringing this very innovative biomarker into practice while at the same time contributing to improving patient care. So a few words about my background. So I hold master in science and also MBA. I have 20 years of experience in the in vitro diagnostic industry and life science industrial as well. I've been working for Roche 20 years, this mix more than 6 years and also meanwhile, have been joining a startup company in Paris, which brought me some other experiences. So I might say I have quite extensive experience in sales, marketing, business development and market access in multiple disease areas, such as oncology, cardiology and infectious disease, including sepsis already. So to me, I also have as an experience, which I believe is important is I have been involved in the launch of several disruptive technology. And NU.Q NET is exactly that, a disruptive technology, which entices having a different approach to long the product to the market as compared to more mature products. Right. So our focus with this Nu.Q NET biomarker is to develop, as already been said, low cost, easy to use diagnostic test with 2 major aims and positioning. So if we are reflecting back to the patient journey, a presentation at the hospital, this test may help to risk stratify. And later in the hospital state, this test will also enable to monitor the disease progression as well as the response to the treatment. So what have we been achieved so far? So we have first demonstrated the real potential of this test to contribute to early detection of sepsis. As Andy has also shown us, this biomarker strongly correlates with the 2 major clinical scores, so the SOFA score and the Apache 2. We've got the CE Mark IVDD last year in May, which is a labor of having brought to the market a very reliable, analytically validated, reproducible and rapidly available test. So those are some features, very important to convince potential users in the future that our test is very important and powerful. So basically, in terms of strategy, we have 4 building blocks. I would say, that would help us to transition from more R&D type of company into a product-oriented organization. So I will come in more detail to those different aspects. So if we want to become a test, if you want to make this test being used in the future and if we want to guarantee a test adoption, there are different key components and strategic elements that we have to follow. So the first thing we have done last year was to become a member of the ISF. So ISF stands for International Sepsis Forum, and the ISF is an alliance of key experts in the field of sepsis, and they are joining forces in order to fight again sepsis. So that's very important because this is the best way to understand what is the standard of care today, what are the unmet needs and together with them to get advices on what the route that we should follow. Next to that, important because we are, again, not talking about a test that is very well understood, acknowledged and already in the market, but rather, we have to pave the way. That's the reason why we have to focus first on centers of excellence. So those centers of excellence will help us to deliver clinical utility value and help us to convince the vast majority of the market about the interest of our test and also to enable them to adapt the test more easily. As of now, we have issued several publications and posters and we have also some under preparation that will be released in the next weeks and months. Because U.S. is the largest market in health care in general and in sepsis in particular. It's very important for us to address this very huge market, which has, of course, some specificities in terms of market clearance and products. And what we have already started to undergo is breakthrough device designation submission that we expect to be submitted this quarter. A few words on the commercial strategy. So again, if we consider Volition major assets, I think it's our ability to develop novel biomarkers internally but also with research partners, then build up a strong portfolio of IP, as Cameron mentioned, because this is the way to protect ourselves. And once we have done that, the best way to monetize and get return of investment is to join forces with IVD companies that are well equipped and have far more experience and exposure than us to all the markets worldwide. And this is exactly what we are doing. We are starting to establish partnerships with the big players in the field of sepsis in the field of thrombosis as well because [indiscernible] also explained the very strong interconnection between sepsis and immuno-thrombosis. And just as a reminder, so the underlying, I would say, principles behind that are low CapEx for the potential partners because it will be about transferring our technology into their system with some fine-tuning, not more than that. And for us, interest is low OpEx because we will delegate, I would say, and rely on the market expertise of established companies. And in doing so, again, this will enable us to access the market on a wood-wide basis. So as I already said, we are under discussion with some major players. So what set us apart? Just will be the conclusion, by the way, and this was already mentioned by Cameron earlier. So the idea here is to enable the test to be used for everyone, anywhere, anytime. And if we now look at how the diagnostic markets is set, we have very huge big central labs with robotic change. You just put the sample in and then get the result back. But it's also very important in certain instances to be close to the patient or need to the patient with point-of-care solution. So we are agnostic in terms of technology, and we believe that we have to address test by test, point-of-care setting and very large reference labs or teaching hospitals with robotic chains. And remember that, as already been said, time is critical. And if we want to improve patient care, we have to deliver results in a very fast way. Thank you very much.
Nik Wood
attendeeVery interesting there to hear from a hero from the sharp end, a practitioner and also, we hope a hero on the commercial end as well, and I'm sure many people will be interested in the development there. Relation, as you know, growing internationally. Just worth mentioning Jasmin from Singapore is here, a great potential for the future in Asia, both on the human side. I know through my personal commercial experience on the companion animal side as well. But there is this tremendous link between the U.S.A. and Belgium, where, of course, Volition have their facility in the Namur area. Now I actually thought Wall Street being a typical journalist, I just look at the simple fact was actually about the wall between New Amsterdam of Bricks who came over and tried to rule everything. But I was informed in no uncertain terms by the Belgians in the audience today that actually Dhaval threat, I think was known as the center of a small Walloon community in this area. And of course, Walloon actually is the area in which they are situated in the Namur area. Now Volition didn't just come to the New York to ring the bell and get a lot of money out of this country. There are real links now forging between the 2 areas. And some breaking news here, I've just learned that the U.S. ambassador to Belgium has asked to come along and meet the Volition team in Wallonia in Namur and actually find out more about what is going on. And what is going on over here in the U.S. is that there is an exciting new development, a new laboratory being developed right over on the West Coast, great surfing country, as we discovered over in the San Diego area in Carlsbad. And it's a nice segue really from the human side that we've just been talking about as we now move towards the veterinary side, and we'll hear more about that in a moment. And this really is an impressive facility. We wanted to show you more about it. So instead of me droning on about it, my colleague Fiona Malloy, who works with me, took her cameras along and her editing expertise. And we have a short video just to explain to you about this facility and what it's doing on both aspects. So let's run that video now. [Presentation]
Nik Wood
attendeeStory, which takes us neatly over into the Volition veterinary space now. And I was saying earlier, I mean, if you want an illustration of just how crazy the companion animal market is going, you have to go no further than our hotel room this morning on Fox and CNN news, where we've heard on top of the dog kidnapping that were happening in parks around New York, actually, somebody was held up at gunpoint in their house on the doorstep yesterday so that their young [indiscernible] puppy could be stolen. I mean the market is going crazy around the world. I'll just come back from Australia 2 months in Bondi. It is just full of dogs and also in the house cats. So the veterinary market is vast and people are spending money to make sure [ their for balls ], as we continually hear are kept healthy. So it is an enormous market. So this is a very important part of the Volition presentation today and a very important person with Volition veterinary is Dr. Tom Butera, who is going to come and talk to us about this particular area. Tom, welcome.
Salvatore Butera
executiveI want to thank everybody for being here today, and I must admit I've always had a love of the way the BBC presents things. And Nik, of course, has done a phenomenal job in doing that today. I am a veterinarian, Tom Butera, and I have 2 colleagues that are going to be speaking to you today as well. Dr. Heather Wilson-Robles is a renowned veterinary oncologists. We'll be speaking to you per video. She's not able to be here today, but should be describing some information on new monitoring tests. And then, of course, we have the wonderful veterinary oncologist AKA cancer specialist, Dr. Sue Ettinger, who is live here today with us and is -- we're delighted to have her with us on board. A little bit about myself, just to kind of give you -- I mean, obviously, I've got white hair, I've been in the industry for a period of time. I've done everything -- done quite a bit with reference to academia, teaching and academia to spending a number of years in clinical practice corporate ownership, corporate development and a significant amount of time and business development leadership at had several corporate groups. One of the most important thing that's relative to what we're talking about here today, I've also been an investor in Volition for quite a number of years. And interestingly enough, I think maybe if any of you had an opportunity to see it, 60 minutes had a special on back in December 2022. Speaking about the interrelationship and the significant importance of having the animal companion animal industry and the diagnostics and therapeutics that we find about cancer interrelated and how that can benefit the human side and also vice versa. It's dynamic. And one of the few dynamic companies that I'm aware of in the world that has that capability and is doing that right now is these group of people that are in front of you today, whose having a veterinary component and an animal component of working collaboratively together is an immense undertaking and something that hopefully will save a lot of human lives in the future, not to mention a lot of our pet slides as well. So to give you a little bit of idea about the opportunity on the commercial side, and I'll be speaking briefly today because I don't want to take too much thunder from the 2 esteemed veterinary oncologists that are with us today. But the opportunity is immense for what we have in front of us. Our new CVT cancer test is specifically a screening test designed to be used in wellness physics for people that have dogs that are 7 years or older and also for those animals that are predisposed breeds of which there are about 30 of them starting at the age of maybe 3 to 4 years of age. One in 4 dogs dies of cancer every year. 50% of dogs over the age of 9, 10 years of age, die cancer. 84 million dogs in the United States, half of them come in for an annual wellness test, at least once a year. Every one of those dogs are pretty close to every one of those dogs as an opportunity for us to have an affordable, accessible cancer screening test run on their dog. We and these veterinarians in our toolbox have not had something that's affordable and accessible. We have pretty much unfortunately put many— [indiscernible] testify this. We put -- we've said too many tiers. We've put too many dogs to sleep because they were sick, that 1 and 4 that I gave you. Would have been wonderful if we've been able to detect them early when they were well and when they were healthy. Being able to treat dogs that are healthy, just like humans. A lot of us are going for screening tests, memory test, prostate test. You're trying to catch things early. If you catch early, consequently, the treatment should be more successful and should give you a better lifespan. And hopefully, in particular, I'll use the word lymphoma because that's lymphoma and hemangiosarcoma or 2 diseases that comprise close to 35% of what we see as veterinarians. Right now, lymphoma, in particular, is a treatable disease. Wouldn't it be wonderful someday that we can tell people that it's a curable disease. You can't get there without having an early detection. You can't get there without having dogs that are in front of you that are well so that you get an opportunity to detect them early, which is what our technology is capable of doing. That's where we start. That's the revolution that we're going to begin to be part of -- and that obviously is going to lead into many potential benefits of early detection, in particular, treating them early, as I mentioned, having better success treating them early because you're not dealing with compromised orients. They're not sick, but they do have circulating cancer cells, nucleosomes in their bloodstream, which can be picked up. The other thing that -- as investors from the standpoint of someone and I'm sure some people in here obviously own pets. The cost of treating animals that are sick is extremely high, especially when we talk about cancer because ta lot of the cost is based on the organ dysfunction that's occurring with metastatic disease, where they're sick and you're having to use a lot of supportive care, a lot of expensive supportive care to keep them alive while you're treating them. Well, if in fact, we are treating them early and they are well that cost should be significantly reduced. And the survival -- the survival should be significantly improved. Therein is where we're at. Hopefully, over time, because we are treating these well animals, we will come up with new therapeutics that will be more effective in treating well animals and hopefully, some of the very extensive 60-year-old therapeutics that we're using now, both on the human side and on the animal side. Maybe when we're using them on well animals, we'll have more success, just like with well human beans, Dr. Redan very well, a lot of the cat therapies and all of the things that are being developed on the human side, and I'm sure that, that will come over on the animal side as well. So it's a major opportunity in front of us and Volition both on the [indiscernible] side and the human side is right in front of it. The total TAM worldwide, $11 billion, just to give you a little bit of color around that. Half of that is with dogs and half of that is with cats. We currently are doing pre-analytics with CAC this year, and we're trying to identify feline lymphoma and cancers and cats. So it's about a 50-50 mix. And then the other part of it is screening and then monitoring and Dr. Wilson Roles is going to talk to you about the monitoring paper that just came out yesterday, 2/3 of what we -- of that revenue stream will come from screening and about 1/3 of it will come from monitoring. Overall commercial strategy. R&D, as Remi had mentioned in his lovely presentation is conducted by Volition and its research partners. Volition monetizes IPs, commercialization via global purposes via our global players, free and fragment end markets and regional companies. Important to remember here, partner with established diagnostic companies to market, sell and process our tests. We're not in the business of developing a sales force. And we're in the business of signing major contract distributions with major partners that have major sales forces and major distribution channels throughout the world. Our goal is to put our test in front of every veterinarian possible so that they can utilize this test and hopefully save a lot of pet slides. Underlying principles, and we mentioned this before, Remi mentioned it, low CapEx for our partners and low OpEx Volition with a worldwide accessibility. Just to give you a quick update, commercial deals, May 2023 update. We signed a global agreement with the IDEXX Laboratories. They have close to a day of 80 labs around the world. They're one of the top diagnostic companies in the world. They service over 55,000 veterinary hospitals in the world, and they have some major worldwide distribution. The first part of, we just launched with them in January of this year, the Orlando Veterinary Conference, and there were 26,000 veterinarians there, and that's going very well. We're delighted with it. They are planning on launching in the second half of 2023, going into Australia, EU, the U.K. and Canada as well venturing into Asia as well. So we're going to, over time, going to have some pretty significant distribution. And we're also absolutely delighted. We signed a $28 million contract with our partners at Heska. Delighted with our collaboration with them, they're great people to work with. We got a $10 million upfront milestone payment. And over the next couple of months, we should be finalizing the optimization of that point of care instrumentation that we talked about, point of care means that's an instrument that's actually in the hospital of the veterinarian, so that they can access this piece of equipment, pull the blood, put it in a cartridge and get that sample run in about 10 minutes and provide that answer to the client. We have that $13 million should be coming there. And then, of course, when we finalize our work on cat, we'll get another $5 million from Heska that should probably happen sometime in 2024. Plus, important to remember, every test we sell, every kit we sell, whether it's through Heska's reference lab or eventually through the point of care and every test we sell through the reference labs through IDC, Volition makes money -- every test, ongoing revenue, and that revenue is beginning to ramp up and will continue to ramp up in the coming months and coming years. Finally, the scope, companion animal cancer point of care. The point of care is about a 10% to 15% market, but we feel, especially with the usage of the point of caves coming out with Heska, where we can have our tests available right away from a screening perspective, we think there's going to be a gain in the market share in terms of that type of instrumentation for our client base and our veterinarians. Launching Via Heska's veterinary diagnostics lab was also launched in Colorado in the U.S. as well as in -- we do also have a couple of labs in Europe right now, 1 in Italy and 1 Portugal, a usage in a second. You've all heard about that the proposed acquisition of Mars -- Heska by Mars, anticipated closing probably second half of 2023. Our new CVIT contract remains in place with Heska. It should be a very positive outcome for us at Volition, more rapid, more widespread access via expanded Mars network because obviously, Mars owns a lot of veterinary hospitals around the world. So we should have a deeper penetration into the veterinary market with the successful signing of the agreement between Heska and Mars. Global Reach today looks a little sparse. You can see the U.S. is there. You could see Portugal there. You could see my hometown in Italia is there. And then also there's down here near Australia, they're Singapore. The intent is worldwide distribution. This is what we're looking for, for 2023 and beyond, especially when IDEXX launches, especially when Heska continues to roll out, and we are actively pursuing other relationships with other vendors as time goes on. Let me now turn it over to Dr. Heather Wilson-Robles, our Chief Medical Officer and veterinary oncologist and she'll talk to you about our exciting monitoring paper, which just came out yesterday, it was published. This paper talks about disease progression using our test for disease progression and remission. And I think you'll enjoy. And then following that, Dr. Sue and Joel speak. Thank you.
Heather Wilson-Robles
attendeeThanks, Tom, and good afternoon. I'm really sorry. I'm not there in person with you guys, but I'm really excited to talk to you about everything we've been doing for the last year here at Volition. As you guys are aware, the Volition veterinary Nu.Q test has really been used mostly as a screening test for the last few years. Really, we're trying to help pet owners diagnose cancer earlier. And by diagnosing cancer earlier, we may be able to intervene sooner, especially when the animal has no symptoms and can tolerate treatments like chemotherapy or radiation better than they would if we had to wait until they were sick to diagnose it. The Nu.Q test that we have on the market now actually measured nucleosome specifically separate from other forms of cell for DNA using a simple ELISA platform. The Nu.Q test that's currently available looks simply at the total number of circulating nucleosomes in the blood. In the last few years, we've had several publications that have described the use of Nu.Q test for a variety of different cancers. One of our most recent peer-reviewed cases was what we call the multi-cancer paper. And really, it's looking at the 7 most common cancers that are diagnosed in dogs and evaluating how well the Nu.Q test was capable of picking up the elevated nucleosome concentrations in these cancers. We were able to pick up at least half of these tumors and a series of 528 dogs with cancer as well as 134 healthy dogs. And we were able to find that the cancers we picked up most reliably included lymphoma, hamangiosarcoma and hysteocytic sarcoma. Lymphoma and homandiosarcoma make up about 30% of the cancers that we see and are often sneaky and hard to diagnose. Speaking a little bit more on lymphoma androsarcoma, in 2020, we published 2 papers that looks specifically at these diseases. We were able to pick up 77% of all lymphomas with a 97% specificity and 82% of hamangiosarcomas, also with a 97% specificity. We were able to pick up basically 3/4 or 76% of all of the systemic cancers that we tested and again, half of all the cancers we researched. Now what I'm really excited to talk to you guys about today is a new indication for our Nu.Q test, which is monitoring. As an oncologist, this is very important to me. I actually don't screen a lot of cases for cancer because they come to me already diagnosed. But monitoring now this is a tool that I can actually use every day in my clinic very reliantly. So this new paper that was just published yesterday uses lymphoma as our sort of classic disease for monitoring. So I'm going to go through a little bit of the details about this paper and kind of get you caught up to speed since you probably haven't had time to read yet. Lymphoma is one of the most common cancers that we diagnose in pet dogs. It is a systemic disease where you have malignant lymphocytes that are in the lymph nodes, in the [indiscernible], in the liver, and it really pops up everywhere all at once. Because it's a systemic disease is typically treated with chemotherapy, the problem is it's not always easy to know when these docs are in remission. And so we use a CHOP protocol. Now this is a combination of 4 different drugs. There are 4 cycles of these drugs. So we kind of give these drugs 4x over this protocol in these different cycles. And as we treat them, again, up to 25 weeks, we're trying to figure out, are they intermission, are drugs working, should we be switching to something else. This new monitoring scheme allows us to better evaluate whether or not we are able to get these dogs into remission and probably a bit closer to that gold standard, that holy grail of oncology that we refer to as molecular remission, meaning we use X-rays, we use ultrasound is bloodwork. Restaging adult crude cost as much as $1,500 and we're trying to do that maybe every 2 or 3 months in these guys on top of the chemotherapy expenses. So having a cheap, easy, reliable way to monitor these guys and determine whether or not they're in remission would be immensely helpful for someone like me. Circulating biomarkers can fill that unmet need, and that's really what we've tried to demonstrate here with this paper. So currently, in this paper, we looked at 40 dogs with what we call hematopoietic malignancies. That means malignancies that come from the bone marrow. Lymphoma being the most common. So 37 of those 40 dogs had lymphoma. We also looked at 2 logs with leukemia and one dog with another disease called multiple myeloma, which is like lymphoma but made with plasma cells instead of lymphocytes. We looked at the nucleus one concentration at diagnosis, during treatment and then while we were monitoring them in remission for them to come out of remission. The one thing about lymphoma is that it will always come out of remission, 99% of the time. This is something that we know they're going to come out. The question is when and how often should we be monitoring them. There are a few other biomarkers that have been tried to monitor lymphoma, things like C-reactive protein and vimentin kinase 1, but they really haven't been adopted by veterinary oncologists simply because they're not very reliable. And so we aim to show in this paper that nucleosomes are better than those markers at monitoring lymphoma. And fortunately, for us, we were right. So if we look at a little bit of the data, and I promised to not bore you with too much of it, but if you put just a little bit of the data, what we can find is that 28 of the 37 dogs with lymphoma did have elevated nucleosome concentration at diagnosis. That's about 75%, which falls right in with that 77% sensitivity that we've been talking about historically. 2 of the dogs that did not have elevated values had something called indolent T-zone lymphoma. These are really sort of well-differentiated benign lymphomas that often don't have elevated nucleosome concentration. So those guys can kind of be put to the side. But the other hematopoietic malignancies like the leukemias and multi myeloma also had elevated nucleosome concentrations and those concentrations tracked just like the lymphomas and monitoring. So what this particular graph here shows is that we saw a significant difference when the nucleosome concentrations at diagnosis as well as add remission and then a disease progression. So these dogs were high at diagnosis. And then when we treated them, their nucleosome concentrations dropped to the healthy range. In fact, all but 2 dogs had nucleosome concentrations that return to the healthy range, those 2 docs that did not have the shortest progression-free survival, meaning the shortest remission times of any of the dogs that we saw. These guys then came right back up when their disease progressed. So when their tumors were coming out of remission, the nucleosome showed that with a simple blood test that didn't require ultrasound to Chest x-rays and a ton of blood work. Another interesting fact was that these guys who had elevated nucleosome concentrations, the highest ones, right? So we kind of got 3 levels. These guys that were in the highest level did not do as well. The remission times were shorter than those guys that were in the medium or low zones. This can be very useful to pet owners and veterinarians to say, your dog is in this middle range. They may do better than the average dog with lymphoma or your dog is in the high range. This may mean that they're going to do worse. And does that change how you want to treat them or how you approach that case. Just to give you an example, I'm going to tell you about one of my patients, Bell. So Bell is an Australian Shepard. she's young. She's only 3 years old, unfortunately, and she was diagnosed with B-cell lymphoma. If you look at this graph, you will see the red circles are when she had active disease. So either at diagnosis or when her disease came out of remission. Orange circles represent when they're in a partial remission. They're responding, but we can still detect disease and the green circles are when they're in a complete remission. Now this is based on our previous methods of how we monitor dogs, right? So me using my hands to see if the lymph nodes are small, lab work, things like that, but not any real molecular measurement of when their disease is progressing. So you can see at diagnosis, she's very high. We start chemo, she drops right down below that green line. That green line is our healthy line. She drops right down below that green line and sort of hovers there throughout treatment. However, as we get to that -- those last 2 chemotherapy treatments, you can see that her nucleosome shoot up. CRP comes up a little, not a lot. And the dieting kinase 1, hardly changes, right? But the nucleosome concentrations really come right back up close to 600, which is where it was when she was diagnosed. But based on everything we know from physical exam and blood work, she was in remission. So we let her go. She finished her protocol. And then sadly, only 3 weeks later, she came back in and her lymph nodes were visibly enlarged. And of course, she was clearly out of remission by physical exam at that point. But if I had known at the end of her protocol that she had elevated nucleosome concentrations, I probably would have done additional testing, I certainly wouldn't have waited 3 weeks to get her back and I definitely would have continued her chemotherapy. So here's a situation where we hadn't gotten these numbers retrospectively, we probably would have treated Bell differently. So just kind of as a summary, monitoring applications. So how would we use this. This is a way to track these nucleosome concentration to route treatment and see where we're going. They really do track very well with the disease better than other biomarkers that are currently out there. Regarding wind to test, the key thing about this and the wonderful thing about having an affordable test is that we want to check these guys multiple times. I recommend in the paper that oncologists use this test at the beginning when they're first diagnosed, at least once per cycle, so at least 4x through that treatment and then at the very last treatment. I then recommend that they test them every time they come in for a recheck with lymphoma usually is every 4 to 6 weeks with other diseases like common sarcoma, it might be every 2 months until you find progression. One of the nice things about being able to use this test is if it is elevated, but you don't find evidence of disease at the time. you're not going to wait another 2 months to get them back in. You're going to get them in, in 2 weeks so that you can actually work a little bit earlier and try to knock that disease back with chemo or other therapies sooner rather than later, again, when that dog is feeling better before they're really starting to show symptoms of their disease. And now Sue, take it away.
Sue Ettinger
attendeeHi there. Welcome. I have to say I speak all over the country and the world, but this just feels different. So bear with me. But I'm super excited to be here. I'm going to give you my perspective as a medical oncologist with how I'm using this in practice. I have been consulting for Volition, I think, 3.5 years. I don't know. 2 years, it all seems -- it's like COVID years, right? Everything just sort of seems fun together. But what I want to do today is tell you some of the questions that I'm asked, how we're actually implementing this into our veterinary practices. And really -- so I go out and speak to general practitioners, and they are so excited about this test because one of the questions we all get asked is, is there a blood test for cancer. And up until now, there really hasn't been. So first thing is what patients are we screening. And so as Tom mentioned, and I think Heather mentioned as well, all dogs over the age of 7. And one of the things I'm always reminding veterinarians is that dogs age at different rates. So our great days are larger dogs, they're going to age more quickly. So we want to think about that as well. But I think a good place to start for our healthy pets when they're coming in for their wellness exams is over the age of 7. These are some of the high-risk breeds and Labradors are on here, and I have labs, and I always pretend that I don't see them. But my Labradors have been tested with this as well. Penelope, starting at around age a little -- just before 5 and Matilda is 13. Luckily, so far, all the tests have been normal. But for these dogs are at high risk of developing cancer. I usually recommend Tom mentioned about 3 to 4. I can also tell you some pet owners and colleagues who have lost dogs to cancer with golden retrievers. They're starting to run it even earlier at age 2. And when I think about my patients that come in and I'm treating them for cancer, they often have other pets at home, right? And so they want to know when should they start screening. So again, a 7 is good for most of our dogs and then one of these high-risk reads usually around age 3 or 4, if not a little bit younger. When do we screen? So we want to be doing this as part of their wellness exam. This is a test that you need to be running on healthy, faster patients. So again, when they're coming in for their routine exam once or twice a year. I usually recommend twice a year for our pets are middle age and older pets to be screened for cancer. Some people will say a year. But when I think about how dogs age, right, we say 1 year in a dog lysis 5 to 7 years, and that's a long period of time to wait between visits. So I really think when they're coming in middle age and older twice a year includes the new QVT cancer test. And then as we mentioned, early detection, better outcomes, and that's really the goal of what we're doing. So how do we find it? And so there's 3 places now available in the veterinary market. Originally, it was just Texas A&M, which was great, but it did require that veterinarians box it up and ship it, which is that one extra step. As Tom mentioned, when I presented in Orlando at the largest veterinary conference, BMX, and I told the veterinarians that it was available at IDEXX, there was literally an audible like, oh, they were so excited because that just means when you're pulling the rest of your blood work, you can check it off on online or on the actual physical paper sheet, and you can get it back with your regular blood work. So it's just easier for that. We're also available the Heska veterinary diagnostic lab. I just started using them in my own practice as well. I submitted it on a young dog. She's barely 5. I've been treating Sofia for about 2 years for a high-risk mass cell tumor. She's in remission. And I said to mom, she's a boxer. She's 5, we should include the new Q. I submitted it on a Monday, got it back Tuesday evening. Mom follows me on Instagram. I DM her on Instagram at the test was normal. She was so relieved that you didn't have to wait. And we just had a clean bill of health for Miss Sofia. She's a durable little boxer. So what results do I receive? We get it back in 3 different categories. The one that we want, the one that Sofia is low risk. We call that the green zone. Then we have our high risk. This is a screening test. It's not a diagnostic. So once we get that back, we'll talk about the different ways that we're going to work up that patient. And then sometimes you get back, I call it the annoying gray zone, the one in the middle. And so that is maybe the patient wasn't fasted or you're going to have them come back. And we're going to run through that as well. So if it's a low risk result, you're going to have them, you can repeat it at the next wellness exam, whether that's in 6 or 12 months. For that gray zone, the test requires a 4-hour fast, which I have to tell you, in veterinary medicine, not a big deal. And overnight fast, I have labradors. Anybody have labs, any of the golden retrievers. It's mute if I don't feed them in the morning. But the nice thing about a 4-hour fast, if I know I'm going to run a new queue is we'll do an afternoon appointment. And so we can do an appointment at noon, 1 or 2 in the labradors. Those breeds that love their breakfast can still get it. If it comes back in the gray zone, we're going to check with the pet parents that the pet was fasted. If they were faster than I usually recommend repeating the test in about 2 to 4 weeks. Most of the time, the motivated owners will want to recheck it sooner rather than later. And then as I mentioned, if it comes back in the high-risk category, then we're going to proceed to the diagnostic pathway. The most important thing is getting that patient back in and repeating your physical exam. So now I'm thinking about some of the cancers that Heather and Tom mentioned, lymphoma. Did I feel my lymph nodes well, so we're going to go back feel those lymph nodes? And just a good physical exam, field of limb now, do everything an oral exam, a rectal exam. We know that some of the oral melanoma can be picked up, [indiscernible] carcinoma as well. To be honest, most of the time, the laboratory tests have already been run. You are pulling blood for a wellness exam. But if you haven't run it, I will advise veterinarian to run basic blood work, urinalysis and things like that. And then we're going to proceed on to more advanced diagnostics, maybe an aspirate of a mass, something that we see on Chest X-Rays ultrasound, and we may do an [indiscernible] a biopsy and submit that to the lab for analysis. In some cases, we're still not finding the cancer. We may then move on to advanced diagnostics, such as the CT scan, which in our veterinary patients does require general anesthesia. Another question I get at the end of every time that I talk about this test is what about cats, you always talk about this test for dogs. We do love cats and they are working on a test for cats. The clinical study is expected to start later in this year and then hopefully proof of concept in 2024. So cats are often species that hide their symptoms hide there when they're sick. And so we often find a lot of their diseases late. So again, this is going to be really helpful to be able to screen heart cats when they're younger. I’m going to share 2 case studies of mine that have actually used this. You can see how we're implementing it into practice. First one is Poly. She's 15 years old when I met her, and I think this was 2022 was during one of the COVID flare-ups again. But when I met her, she was 2 years out from being diagnosed with bladder cancer. She had been seen with another oncologist in the Connecticut area, and they had treated her with an oral chemotherapy drug, September 2021, so rover 1.5 years out. They set the medication. She was having some side effects that oncologist left the area. And she started to show some urinary signs again. She was having accidents, there was blood in the urine, straining to urinate. So her primary care veterinarian had her come back to me to talk about how we could treat her bladder cancer. We're doing exam. She has just things that I call pretty standard for middle agent, older dogs, some charter, a heart murmur. Our plan was to make sure the cancer, the bladder cancer had not yet spread to places like the lungs and abdominal organs. So we're going to do some chest X-rays and adnominal ultrasound. And then if everything looks good, we're going to restart her on a new chemotherapy drug. Chest X-rays were clear, but unfortunately, her ultrasound showed us clinic mass, a very large clinic mask cavitated. So we're concerned that it's filled with blood. We're concerned that it's [indiscernible] sarcoma, which is a very tough aggressive cancer in arcane patients. And so now I was spending on starting here for chemo in her bladder cancer, and I find this clinic mass and we're curbsides, -- the owners are in their car, have to call them on the phone and say, -- not only do we see her math when her bladder is back, unfortunately, we have this clinic mass. I tell them about the new queue. I say we can run the new queue. If it's normal, it's going to lower my index of suspicion that this is a malignant angiosarcoma. If it's abnormal, we're going to be more concerned. And so we held off on restarting her for her chemo for bladder cancer and decided to submit the Nu.Q. Got back her results a couple of days later. It was in the green zone. It was normal. That gave us the confidence before they didn't want to take her straight to surgery. She's 15. She has bladder cancer. But now they're like, okay, this is most likely benign, they decided to take her to surgery. Is her Nu.Q score. At this point, I was using Texas A&M. They were the only ones available at the time, and her score is in the green zone. Then she went to surgery. She had a splenectomy, so her spleen was removed. And this is for any of the histopathology geeks out there. This is our normal benign spleen. It came back of splenic hematoma likely arising from something called a Milo lipoma. She then went on and I treated her for about another year for her bladder cancer. So really, really exciting. Again, it's not a crystal ball, but it gives the owners the confidence to move forward with her surgery in this 15-year-old dog. This is Otis. Otis was a little bit younger and a little bit meaner than Poly. He was a very aggressive [indiscernible] that came to me after he had been diagnosed with lymphoma. So it was B cell, the more common type of lymphoma that we see in dogs. It was Stage 3 in the liver and spleen -- I'm sorry, in just the lymph node is liver and spleen were normal, and he was what we call substage A. So he was healthy. He was strong and he was aggressive. These owners came to me, they wanted to treat with multi-agent chemotherapy. The [ CHOP ] protocol as Heather mentioned. Unfortunately, this dog required sedation for every treatment because we couldn't touch has legs. We could get a blood sample from him awake, his Dad brought him in with a muzzle. Dad with super sweet. Otis, actually kind of like every one of my team except for me, but we always get to muzzle on him, but he was just -- he was 140 pounds. So this is not a dog that you want to mess with. So he does his chemo. He graduates about 5 months later, and then he's coming in for his monthly recheck. He comes in, in June of 2022. And it those were just a little bit big, not ginormous, not really, really big, but enough that I was worried that is lymphoma had relapsed. In a normal dog, sorry, Otis, I would-- aspirates lymph nodes and put the sample on a slide and send it off to the lab or look at it myself, not Otis I can't touch him. Unfortunately, he had not had an overnight fast because we weren't expecting to need to sedate and who was just coming in for his healthy lymphoma recheck. I know you think that's an oxymoron, but it's not. It was doing really well. But he hadn't eaten since breakfast. So it was over the 4-hour mark, it was about 5 hours. So I could pull blood on this dog, but I can't ask for it as [indiscernible]. So we talked about doing the Nu.Q to see if that was elevated, and that would help me decide whether or not it could bring Otis back sooner rather than later to aspirate as lymph nodes. Unfortunately, as you can see, it did come back on the high risk. I called dad, I said I am concerned that is mildly enlarged lymph nodes could be an early relapse. Dad was willing to restart chemotherapy, if that was. So he sedated him -- he brought them back in a couple of weeks later. I think it was about 2 weeks, dad was traveling. We sedated him for those lymph node aspirates. Unfortunately, it did confirm relapse but that Nu.Q gave me that information that I knew that, that was happening. We actually started him on a new drug, oral [indiscernible]. Dadwas looking for something that didn't require quite a frequent visit and didn't require sedation and we just started that about a week later. This is Otis when he graduated from his multi-agent chemotherapy. We do a certificate and a basket sort of our version of ring the bell, which is kind of fitting here, right? Otis is playing with a ball. He's wearing his muzzle. And so he's a good dog. He just didn't like coming in. So coming soon, I'm so excited. I just have to say I'm an oncologist to see the cases after they've typically been diagnosed, but one of my passions is early cancer detection. So I'm so excited about this test. It's simple and it's affordable. And this is the baby that we bring this to me. I'm taking this one with me today. I live in the area. So this is the point-of-care test. So this is the one that's going to allow me I'm supposed to be getting by in a couple of weeks. I've been talking -- I know I've been talking to them. So this is from Heska. This is our point-of-care test. This will allow me a pull blood, get that sample. So Sophia's mom doesn't have to wait 36 hours. And when I'm using it for monitoring as well, I'll be able to get that right here. You say bedside, we say [indiscernible], but I'm so excited about this test. I think it's going to be so great and not just for oncologists who are monitoring their cases as they're treating. I'm just going to put this down here, kidding, but also for general practitioners, right, owners don't want to wait for results, and this will allow them to get those results in 10 minutes. And then if it's elevated, why the pet's already there, you're not going to require another trip for them to come back and think about that pathway that we talked about to work these cases up. So this is the point-of-care test. This is from Heska. It's the Element IPOs. Like I said, I'm going to be getting this or it's going to be available. They were taking preorders in Orlando. I'm just excited about me. Now I'm excited about this and the opportunity for our patients. We'll get these results in under 10 minutes. And like I said, just allow veterinarians why the pet owners are still there to talk about the results. I hate calling owners on the phone and breaking bad news. But now we can go in the room, sit down and talk to them face to face. And again, it's going to allow that work up and that intervention early diagnoses better outcome for our patients. But don't take my word from it. We do have some of my colleagues who have also been using the test and are excited as well.
Nik Wood
attendeeCan we que the video. [indiscernible] operations room. [Presentation]
Nik Wood
attendeeSo that's a great way to finish the formal part of the presentation where you hear from practitioners again, and we've heard from practitioners in various walks of life throughout this afternoon. We're going to move towards the final question-and-answer session before we go down on to the trading floor. So if I could ask our previous speakers to join me in a line like a shooting gallery on the stage, we'll be able to hear some questions. Just a reminder to our audience here, if you want to send it this way or particularly to our webcast audience, if you want to send a question to investorrelations@volition.com, we already have a series of questions that have come through, but you're very welcome to send some more questions. Please, in the audience. If you want to ask a question, just put your hand up. We have 2 remote microphones here. If you're prepared to identify yourself and your affiliation, that's fine, but you don't have to if you don't want to. But I'm going to put somebody right on the spot because I think I've spotted in the audience. Mr. Provident, Anthony Providenti, from the Heska Corporation. Where has he put your hand up? There he is. So I'm going to drop on him now. He doesn't know this is happening. But bearing in mind what you've heard there, Anthony, just give the audience a bit of reaction and a bit of insight onto the market that you're going to be dealing with.
Anthony Providenti
attendeeWell, it was a great presentation. So thank you for that. We're on the veterinary side only as Heska Dr. Ettinger, I promised my own veterinarian a unit as well. So we may have to arm wrestle for it later. We are super excited, though, that the progress of the development is what we believe to be in the last phases of optimization. Everybody is super excited about that. And the finance people in the room should be excited that, that leads to some milestone payments. I think it's 13 million total, $6.5 million each for screening and monitoring. We were excited to see the monitoring paper released yesterday as well. So we feel great about the progress, and we feel great about the enthusiasm for bringing this really novel approach to screening pets. We're super excited about it.
Nik Wood
attendeeAnd I kind of know what the answer is going to be to this, which will probably be a blank, but I'm a journalist still. I'm going to ask you about Mars, can you tell us anything about Mars from your perspective?
Anthony Providenti
attendeeI would love to tell you a bunch about it, but I've been advised that that's not a topic we can speak to.
Nik Wood
attendeeThat sounds like lawyer speaking there. Well, thank you very much, Anthony. I dropped on you there, and thank you very much for kicking us off. So in our [ Shooting Galleria ], we're going to be shooting first at Dr. Reta because we have a question just come through hot off the press. The inputs into the SOFA scores and Apache 2 scores are tests and observations that seem routine, cheap, easy and fast and likely done routinely in the ICU, while will a net test be better? Do we have any data suggesting that the net test is more prognostic?
Andrew Retter
attendeeYes, we do have some data that is more prognostic. The data is imputed automatically in lots of systems, but we always miss bits of it as well. And the scores are more although they can apply to a patient, certainly safe applies to a patient patch or a population score. They're more a research test to compare the sickness of patients and studies. What none of those [indiscernible] scores do is tell you about activation of urinate immune system. And the point I was really trying to get across is trying to identify this regulated host immune response. They don't do that. And they tell you someone's potentially sick, but they don't give you the resolution that the test us.
Nik Wood
attendeeAnd before we leave you, I did have somebody asking about the geographic significance of sepsis. Now I've worked in some pretty remote areas, Africa, Asia, et cetera. But Am I right in-- or are we right in thinking that this is a global issue. It's not just poor countries, it's rich countries, it's every country.
Anthony Providenti
attendeeSo the data from the Lancet Commission is over 50 million people probably accounted to be really rigorously there'd be even more 50 million-plus cases a year, 11 million plus deaths and it's everywhere, every aspect of life, every population every so population, every race done is universal.
Nik Wood
attendeeSo will we see a big market. Do we have any questions from the audience [indiscernible].
Anthony Providenti
attendeeWhat's so exciting is it's a cheap rapidly available test that you can potentially deliver. It doesn't have to be in a teaching hospital or university app. It doesn't require lots of complex technology to run it. I mean, you've seen us that's not for humans yet, but its direction of travel, and that's where it's up scalable too. And that's really transformative for delivery of health care.
Nik Wood
attendeeOkay. Do we have any questions from the floor because we have more questions. Yes, this gentleman over here. We will just bring the microphone a bit. Just once we're coming to you, I'm going to stay on NET, we're going to come to you next, sir. Keeping with NET, this question is for Remi. When do you expect to submit for breakthrough device status and if received, by when do you expect to launch the test in the U.S., no pressure here, Remi.
Remi Rabeuf
executiveSo as I said, submission is expected this quarter. Then we will have to sit down with the FDA and undergo regulatory trials in order to get the FDA clearance, and we anticipate this to happen by end of 2025, which then will enable us to build up business in the U.S.
Nik Wood
attendeeThank you.
Anthony Providenti
attendeeJust to add to a second we're bringing NETosis over to the animal side as well. We're working on that currently, collaborations in Europe and in the U.S., and we hope to have a NETosis brought on the animal side to our veterinary colleagues in 2024.
Remi Rabeuf
executiveAnd potentially, Europe would be even before the U.S., so starting from next year or late this year as well. So I think it's going to be a very steady building program as the has a similar part to the vet.
Unknown Analyst
analystThanks for the presentations today, everyone. I have a question maybe first for Dr. Retter. I was curious. To follow up on what you were saying before, could you elaborate more on the specific use case for the NETosis test and how it fit into your day-to-day workflow and sort of like exactly where it's being used.
Andrew Retter
attendeeSo I'll come back to the Apache score as well in a second. So we've got this dysregulated immune response. So we know there's activation of calculation of normal clot formation and [indiscernible]. But we can't -- going back through the history of intensive care, and there's been lots of trials with biologically active agents, things like something called activated protein thrombomodulin other agents, they've never worked. They worked in small subpopulations, but they weren't able to work in larger studies. And probably the problem there is we can't tease out the sick enough patients or the subgroup of patients where it works. So for me, what's really, really interesting is that this gives us a deeper understanding of the biology of our patients rapidly. And so it might manipulate what we do. In terms of therapeutics for NET, there's lots of potential therapeutic avenues to attenuate the effects of that potentially lots of potential drugs you could use old drugs, new drugs. And it wouldn't be -- I say it wouldn't be particularly hard to develop an antibody, for example, against NET. That's a large part of how the test works. So I think there's huge potential for treatment options there as well.
Nik Wood
attendeeIs that enough of a answer? Do you need any follow-up.
Unknown Analyst
analystNo, I think that's a good.
Nik Wood
attendeeGreat. So let's move over to the vet team unless we have any other -- just please raise your hand, and we'll certainly fit you in. Question for the Vet team. The product is now available to veterinarians in the U.S. Have you considered a consumer awareness campaign to drive more demand and generate revenue. So Tom, I don't know if you want to…
Salvatore Butera
executiveThat's a great question. Just saying, you know, have the veterinary community works, and I'm sure this is the same on the human side. Our whole focus and attention has been to educate our doctors, in particular, our oncologists initially because they are major KOLs and influencers to the GPs and speak to our veterinary colleagues on the GP side, both in the U.S. as well as in Europe and veterinary staff. They must understand how to use the test and be aware of it. That's our first indication. That's where we have spent our entire time in the last 18 months. Just now, we are beginning to pivot to the consumer so that the consumer -- the last thing we want is our colleagues being surprised by a consumer asking to the test to be run and they don't know anything about it. So they're in lives, we are now beginning to pivot to the consumer. And cancer month is in November this year. Pet cancer month is in November. So stay tuned. There'll be a lot of information that's going out to the consumer by November of this year.
Nik Wood
attendeeSo we've been at various vet shows in the U.K. and particularly this year in VMX and Western. And I think it's fair to say a couple of years ago when we started following you, the audiences were pretty good at your presentations. You always get people coming. But as you said now, well, you're getting rooms bigger than this full of people. And I was there when that [indiscernible] went out. When you mentioned IDEXX. But there is -- do you think that consumer awareness could force Mr. Provident this company to upscale it and also IDEXX as well. Do you think the consumer-driven demand is going to be part of it?
Heather Wilson-Robles
attendeeI think it's part of it, but I think Volition has done it correctly because you need to, as you said, make the oncologist aware of it because they're going to get questions from the general practitioner and then the general practitioners need to be aware of it because the worst thing as veterinarian is when an owner comes in and says, "Can we do this?” and you'll like, “I don't know what that is, right?” And so they don't want to be scooped by it. So I think we're doing it in the right way. I do social media, and I do talk about this test, and I get pet owners that are now saying, "I'm getting it run on a regular basis.” Pet owners saying, "I can get this. So again, I think it's just part of the rollout. But I think -- there is a very motivated group of pet owners that are super excited. Like I said, whether they've lost a previous pet to cancer. They have one like Sofia who's in remission for a different cancer and they want to be proactive and then just overall awareness of it. But I think the most important thing about this test is how simple it is to do. It's a simple blood draw for our fast, like I said, not a big deal and that is accessible. Again, you can -- as we saw the veterinarian in the video, hold the blood and you're just going to throw it in the bag, right, when you submit the rest of your blood work. So I think those are such pillars to this test being successful.
Nik Wood
attendeeCameron, your team to come in.
Cameron Reynolds
executiveAnd there's one that... Absolutely correct. And you've got to put the cart before the horse. But the other very important thing before you get a lot of consumer demand is you make it available to the vet or to the doctor. There's no point if the vet knows about it and you cannot order it very easily. So that's where the big partnerships came in to be so important to us as well. So obviously, you want the vet to know what it is, the veterinary oncologists to know what it is, but you also want them to be able to order it. Otherwise, you're completely wasting the campaign if that's not available. But as of now, the vast majority of vets in the U.S. can now order the test through the companies we talked about. And when we say low CapEx and low OpEx, that means we have not spent a lot of money to get there. We're not a big company. We cannot spend hundreds of millions of dollars, making a large facility and hundreds of sales. People were leveraging the fantastic teams in those other companies. And also, we're not forcing them to use our platform. They can put it on to as Heska is. I think the big companies in the human space were also adapted to that. So low CapEx, low OpEx sounds like a nice tagline, but it's so important for a company our size. Abbott, Roche, IDEXX can probably do a lot more on that side. We cannot -- and nor do we want to. There's all of those things that are already there. We're leveraging the labs, we're leveraging the salespeople and all of that can make us a very profitable company without and also grow very fast. If we had to have all those things ourselves, it would take a lot longer to get there. And we're all about an open democratic product that can be used very [indiscernible] do very quickly. So that's really important.
Nik Wood
attendeeOkay. We're going to wrap up in a minute because it's almost time to go down on the floor. But I'm keen when people have sent questions, we do use them. I won't give this gentleman's name. I don't know whether I have permission to use it, but it's from Kantar, it's Gerald. Question for you, Cameron, again, you're on the market there. Cost of the next test and impact on adoption, obviously, there's a clinical need that in terms of driving broad adoption of what I imagine will be an expensive test, especially compared to the Nu.Q Vet, what sort of data will you need to generate?
Cameron Reynolds
executiveSo we're attempting to make all of our platforms in all the areas, truly low cost, truly adapted to the needs. So if you wanted to be used hundreds and hundreds of millions of times, which I think were at per year, which I think it absolutely can be, you cannot be charging $500, $1,000 and meeting your own sales force. So we want to keep it very, very low cost. And that means in the developing countries, it can be even cheaper than in developed countries. And we are working now. We've gone through the process to get it on the market. And as we have before, we show it works on one platform like in the vet space, others adapt to their platform and launch. So again, we want to keep it very low cost, easy to use and very easy to expand worldwide quickly.
Nik Wood
attendeeOkay. Thank you very much. I think we've pretty much covered everything this afternoon. I'm getting a wrap-up sign from the back from Louise who wants to tell you that there is room for 50 people on the trading floor, so don't all run at once 50 people can go down on the trading fall. The plan is to go down now in an orderly way. And then you will be invited back here just at the back of the auditorium here, to have a few drinks with us, cocktails and also check among yourselves. So thank you to our panel. I think I've been fascinated and thank you to our audience for taking the time to come and see us here. And finally, thank you to our webcast audience as well and also to the technical teams here in the stock exchange. Thank you very much.
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