VolitionRx Limited (VNRX) Earnings Call Transcript & Summary

There we go, we have sound. Well, a big welcome to the New York Stock Exchange. I know many of you have been here before. But isn't it fantastic to get out again, it's brilliant. So a great day today. Volition Capital Markets Day. My name is Nick Wood. I'm not a volition employee, but I do work some of you who have already commented on the videos and the results that we produce for Volition. I'm an ex-BBC business correspondent, BBC Television if you've ever heard of them. Done quite a lot of work out in China for CCTV and basically been an international journalist for many years. So we've been following the Volition story for, I think, nearly 6 years now. And wow, it has been quite a story. And I'm sure lots of you, I hope, are going to have questions today, both live from the audience here in the stock exchange, but also we are joined remotely online. So for those people who are watching remotely, we'd love you to slip us some questions on the [email protected]. That's [email protected]. Now Louise Batchelor, who is the Group Chief Marketing and Communications Officer, is going to act as the moderator and we'll put through some of those questions to me, but we really want you guys to ask questions from the floor because I think there's a lot that needs doing. All right. I wasn't going to change any slides. All right. This is the agenda that we'll be running through today. So in a moment, I'm going to welcome up Cameron Reynolds, who is El Presidente, and also CEO of Volition. And then we're going to hear about Nu.Q Vet. And a lot of interest on the stock exchange floor just now in Nu.Q NETs. So we've got a very special guy to talk to you about that. Anyway, you've heard enough from me. Let's hear from the man at the top Cameron Reynolds, CEO and President. Cameron, over to you.

Thank you, everyone, and thank you for coming. And those on the webinar as well. Really good to see so many people here in person. And as Nick said, great to see us all getting back to normal. So we can actually see everyone. And it's really great that so many of you could be here. And hopefully, we can really help you understand our commercialization path going forward. And you'll probably be relieved to hear. We have a very big strong team now. So you won't be hearing from me very much at all. So I think it shows really the depth of the team we have. We're extremely serious about what we're doing, and to have such a fantastic and growing team, I think, is a real credit to everything we do. So for those of you who are new to what we are, and what we do. We're a leading epigenetics company. Epigenetics is not a word most lay people really understand, and what it really is, is if you look at epigenetics, it means about genetics, which means in the sense genetics is your DNA. And if you think in software hardware terms, your DNA is your hardware, the epigenetics is the software. So in running your system, I guess we all have computers. The software can be a big part of what can go wrong and what happened [Audio Gap] good ways. We -- our aims are nothing less than to revolutionize diagnostics through our absolutely fantastic Nucleosomics technology. And key to all of that is a very strong and growing patent portfolio. Our very known Dr. Micallef Jake will be here, and as almost all of that with our team. So we're in a very strong position. We're listed on this fantastic New York Stock Exchange. We couldn't be happier with the position we are with that with our team, with our science. And I think today, you'll get a really good sense of where we are on the cusp of commercializing some fantastic world-class products. I'll just start with 1 slide. I couldn't get away without saying nothing. So 1 thing just to keep in mind, and I think if we can get any takeaways from today, apart from all the things I've mentioned is just the amazing opportunity we have. Our basic business model is to develop our products, launch them, but then really license widely as we have with the fantastic Heska Corporation, which we'll get to later. And if you look at all the different markets we're in, a lot of people say, what could this mean revenue-wise in year 2, year 5 and looking out? So if you look at this graph, it's a little go ahead, but I think it just shows all the depth of what we have. The bottom axis is the number of tests sold worldwide, and how much revenue Volition would get from those sales. The milestone payments were fantastic and really, really buttress our balance sheet. But going forward, this is what's going to make us a very successful company. So you can see the line there is just the line of what we currently burn as a company. And you can see just a few million tests a year from any of our products to make us profitable. And then at the total addressable market of about $70 billion. If we get to 1, we're incredibly profitable, and that's about 100 million tests worldwide over all our potential products. So we hope to be there in sort of 5 years' time to the kind of the end of the graph, and we're looking in the next couple of years to be through where we're profitable without having -- without the milestone payments. So very encouraging, very exciting. But we're really going to focus on the green and the blue today because that's very close to market, as you'll hear. It has been launched, and we think NETosis as we talk about it, and that's potentially an absolutely massive market. But I won't stand up here all morning. I'll pass over to our very own Dr. Tom Butera, who unfortunately is not able to join us today, but he prepared a video who'll present, [ Joel ] press? Thank you very much. Over to you, Tom.

Thanks, Cam. Appreciate everybody being here today. Sorry, I wasn't able to join you in person, but I do have some interesting and exciting information to present to you about Nu.Q Vet and where we are currently today. But before I go into the presentation, I really want to ask people in the audience, how many of you have pets and how many of you know of pets from me to your friends and family members that have lost their pets, and in particular to cancer. It's a provocative question because it's something that I as a veterinarian had to deal with for 30, 40 years. So I really wanted to kind of talk to you a little bit before I go into the formal presentation. What Volition Vet and what I'm here for is to try to prevent loss. There's been too many times that myself and my veterinary colleagues have had to put dogs to sleep, especially with reference to cancer, way before their time. To give you an appreciation of the number of pets that I and my colleagues have to deal with on an annual basis. Just in the United States alone, there are greater than 80 million pets, dogs specifically, speaking of. And of them over 6 million develop cancer every year. It's -- what we're here, at Volition trying to do is reduce that loss. We're trying to detect things early. When those dogs are looking at you and they're happy, and we don't even know they have cancer, but have a tool that can identify it early, treat them early and hopefully have much more successful outcomes than we currently have in the current veterinary market right now. That's why we're here to address loss. And I hope that you see with some of the slides that I'm going to present to you, this is all related to our mission here, to save lives, save them at an earlier stage of their lives and maintain that human-animal bond that family member for a much longer period. We don't want to say goodbye to them before its time. So with that intro, I wanted to go into some slide presentations, give you an update of where the team is, and to give you some exciting news as to where we're going in the future. As you can see here, the Volition veterinary team has been filled out. We've been working very hard on adding additional members to our team in terms of Product Managers, Director Veterinary Operations, Global Accounts Managers, expanding our veterinary core. We're actively engaged in doing this, and we continue to add to our team and the expansion of it. So our current product portfolio is centered around for canines, cancer screening, with lymphoma and hemangiosarcoma. Now these 2 disease entities formulate close to 35% or 1/3 of the cancers that are diagnosed with dogs on an annual basis. The other point you should also realize too is 70 -- close to 70% of the dogs that are treated for cancer are treated because they have lymphoma and hemangiosarcoma. That's an important point to remember. And then there's, of course, a list of a number of other cancers as well. But lymphoma and hemangiosarcoma are very much on the top of the list. So our current product proposition -- you all know about the new Nu.Q Vet Cancer Test, which is a test we've been speaking to you about in previous calls, predominantly positioned for dogs that are older than 7 years of age as well as for predisposed breeds as early as 3 to 4 years of age. It's a simple, low-cost, easy-to-use ELISA-based screening blood test. And of course, in the third point you see here, over 330 dogs at 97% specificity, which means very few false positives, the Nu.Q tests identified 77% of lymphomas and 82% of hemangiosarcoma. Our product portfolio is also beginning to expand now not just -- is beyond cancer screening, but also -- in the third quarter of 2022, we also hope to have additional cancers detected. And I'll say a little bit more about that in the next slide. Again, we know it's a simple low-cost ELISA test, but we currently have a study of 662 dogs at 97% specificity using the new Nu.Q Vet Cancer Test in a host of other cancers besides lymphoma and hemangiosarcoma. That paper is currently under peer review. We anticipate that it should be in publication form, hopefully, over the next month or so. And we obviously -- because it's not published yet, we cannot give you the percentage of cancer that it detects. So our product portfolio as we continue to expand it, again, in dogs, cancer screening in lymphoma, hemangiosarcoma. Third quarter of 2022, expansion of multi-cancer is being detected, which is the paper I just referred to. And then in the fourth quarter, we are working on cancer monitoring, treatment response and remission. Let me give you in the next slide, you'll see some information about this. Our proof-of-concept with reference to veterinary monitoring was presented at the ACVIM, which is a veterinary Internal Medicine form in June of '21 and the Veterinary Cancer Society again in October of '21. Further data is going to be presented at the European Veterinary Conference -- Veterinary Oncology Conference in Sicily in May of 2022, later this month by both Dr. Robles and myself. And then that paper on monitoring will be submitted for peer review by the end of the second quarter. This test may very well monitor a dog's response to treatment, and also we anticipate we'll also monitor the disease progression, including identifying when a dog may be coming out of remission. It would be common for an oncologist or a veterinarian who is treating a dog to use this test several times during the course of the treatment, to monitor how that treatment is going. And then also, if you can get that dog into remission and back to the general practitioner, that test because of the average length of time that a dog lives from lymphoma, is around 10 months from our current treatment. That -- those remission tests probably will be done several times in -- when they are in the hands of the GP to check to see if, in fact, the disease is coming back. So our goal, obviously, is to detect, to treat early and then to monitor as we just mentioned. Our product portfolio, again, continue -- you can see the expansion of our product portfolio as we go through this, cancer screening, expansion in multi cancers, cancer monitoring for treatment response and remission. And then our POC test, we anticipate, point-of-care test, will be out towards the end of 2022 and potentially in the early part of 2023. Longer-term products that are in development that you should all be aware of -- we are in the process of starting clinical studies on cancers in cats. We are working on NETosis. You obviously know that mitosis is being presented on the human side by our colleagues on the Volition human side of our company. That also will be something that eventually is going to be routed over to the animal side for use in sepsis and detection of sepsis. We're also looking to see if our tests can be utilized appropriately in production animals, and also for elite equestrians. So there's a lot of applications that we are looking into for our expansion of our test development, and all of these are tremendous opportunities for us in each one of these areas. So as you can see, we have started the journey, which has been an exciting one, and continues to be an exciting one to achieve our mission. We have a product pipeline which could absolutely revolutionize the veterinary market. And I think from -- the commentary that I've made over the presentation, you can see that the market opportunity is absolutely tremendous. And the entire team is working diligently to implement our current strategies and to make this a reality in the coming months and years ahead. Before turning this over to Gael Forterre, our Chief Commercial Officer, and he will speak about the commercialization of our Nu.Q Vet product further. There'll be a short video, and they actually will -- the first part of it will be Kevin Wilson, who is the CEO of Heska, who obviously, we've signed an exciting deal with, as well as some other key individuals who will speak about our product and their perception of its current use in the market. Thanks so much. [Presentation]

Thank you, Jasmine. So good morning, everyone. It's a pleasure to be here and present our commercial strategy. As Cameron mentioned, we're in the very stage of monetizing our tremendous IP has been built over more than 10 years now. So in terms of commercial strategy, we're going to rely on a few key principles. The first one is we want to build a platform that is low CapEx for our partners, and we'll talk more about that. We want to be low OpEx for ourselves. So low CapEx, we don't want our partners to buy expensive hardware to be able to run a test. Low OpEx means we do not want on our end to build an enormous team and spend millions selling our test. And the last principle is accessibility. So we want this test to be accessible worldwide at any vet clinics at a low price, so it doesn't -- or affordable price, so it doesn't prevent any pet owner from adopting it. So we will accomplish this in a few different ways. So the first way is we're going to rely on commercial partner. You'll hear more about that. Obviously, you heard about the Heska Corporation and Sage, but there are more to come. We will also focus on being multi-platform. So one thing that's critical for us is to make sure that there is a limited amount of energy spent on partners to adopt our test. And we need to make sure that our technology is then transferred to as many platforms they are already in existence. In terms of commercial partnerships, so we're going to leverage their networks. They spend years, decades, building those connections. They have dedicated sales team. We're not going to beat that. We're going to leverage what they have. And we're going to do that globally with partners like the Heska Corporation. We're going to do that also regionally like what we did with Sage. The goal is really here to maximize coverage and that's really important for us. In terms of platform, so we're going to be available at the point of care, and I'm sure we're going to talk more about that. But point of care is really at the location where the patient or the dog is being treated. And so we -- and that's part of the transaction with Heska. So this is important for us that we are present there. We're also going to supplement this with external labs or reference lab. And that is important because that broadens our coverage. And underlying all this is the tech transfer effectively to the platforms that our partners are already using. So now obviously, we are very excited to announce a transformative transaction with Heska Corporation. It's one of the top 4 vets diagnostic company in the world. It's a global partner. It's a top innovator in the Point of Care space. And it's a very entrepreneurial culture. It's a great match for us. We're really appreciating working with them, and the teams are making a lot of progress together. The transaction itself is actually set as 2 parts. There is an exclusive part and the non-exclusive part. So the exclusive part is for Point of Care. Remember, it's at the Point of Care, very quick results. And non-exclusive for the external lab. I should mention external lab usually have a 24, 48 hours turnaround time. It is for cancer, although we have options to extend that beyond. But it's for cancer on companion animals, starting with dogs and then cats. So canine and feline. In terms of financial considerations, it's up to $28 million in upfront payment. We received already $10 million in. So that's in the bank. We have another $13 million that we expect in '22, '23 and another $5 million, again, best expectation would be 2024. But it's important to see that it's both milestone and ongoing revenue. So those are the 2 pillars of that transaction. We're building a strong revenue base. We're going to get up to $10 per test plus inflation. I know it's a little subject currently. So up to $10 plus inflation. And that's for 22 years. So again, we're building this long revenue base for the next years and decades. So it's both milestone and ongoing revenue every time Heska sells a test. So now what's next? So as you can hear, global coverage is really important to us. So we're going to sign more agreements. We're going to grow this coverage. The goal is to get to 90% in the U.S. within 12 months. 1/3 of Europe within also 12 months. Asia, we're working on that. So we'll have more to say when we finalize that. We expect significant revenue at a high margin. So that's what's next, broadening coverage and starting to grow our revenue base. Now this graph is kind of an adjusted one from what Cameron presented. And it shows how significant the current pipeline could transform -- how the current pipeline could significantly transform the company. It has the potential to be a company maker, and we're going to put a lot of weight to make it happen. So in summary, I want to leave you with 3 key ideas. We have an OpEx-light commercial strategy, leveraging our partners' network. We expect significant revenue at high gross margin. And we're in the very early stage of our commercial journey. We have a lot more coming. So it's just the beginning. Thank you.

Thank you very much, Gael. And despite the slight European accent, then I can assure you, New Yorkers he's one your neighbors, he lives out on Long Island. He tells me. But he says he hasn't quite got the mansion yet until we start buying lots of kits. So you won't mind helping him out on that, that would be great. Thank you, Gael, and thank you also for that great video, explaining the Vet theme. Okay. Again, just a quick reminder. What I wanted to say is if for any reason, you want to share this presentation or the whole event today, it will be available on the Volition website, fairly soon after the ending of the event. So if you need to share on social media or maybe an analyst, colleague who didn't manage to make it you will be able to get it through the Volition website. If you do want to send us some questions, Louise is waiting with bated breath on [email protected], but we're going to do a little gear change here now because, as I said, down on the trading floor, the word had gone around that we're going to talk about new Nu.Q NETs. Now in order to talk about this, we need a scientist with a very big brain, much bigger than my brain, I can tell you. And as we say in true Ghostbuster's fashion, when you need a big brain, who you're going to call? Well, I'll tell you who we're going to call, we're going to call Dr. Jake Micallef who is the Chief Scientific Officer with Volition, who is going to come up and put some picture around NETs. Welcome.

Thank you. What an introduction. All right. The best introduction I've ever had definitely by now. All right. Thank you. It's great to see so many people. And as Nick was saying, NETs is a new area for almost everybody, and it's a huge new market opportunity in medicine generally, and in -- and for Volition specifically. Until recently, I think even medics didn't know what NETs was. And so I'm going to just talk a bit today about what NETs is, so you have a flavor of what it is? Why it is going to be huge in the very near future? And how Volition is positioned to take a huge part in that opportunity. Where do I point this? So a little bit, 2 minutes on what are NETs. When I went to school, immunology could be summarized in 2 bullet points, which is a disservice to immunologist, but never mind. When I was a boy, I was taught that really there are 2 parts to the immune system, you can make antibodies, and the other part is that these white cells come and they basically eat any bacteria that happened to be around. And that was it really, and a few details. And then in 2004, NETs were discovered, and that was a huge scientific breakthrough. When I first heard about NETs, I thought somebody was making it up and pulling my leg because it just sounded so strange. But the essence of what happens is that neutrophil cells, which are white cells, and actually, they're the most numerous white cells, they are 70% or so of all of your white cells, they make these things called NETs, which are Neutrophil Extracellular Traps. And the acronym is for NETs because they are literally a net. What happens is that the cell unwinds all of its chromosomes and throw the whole lot out side of the cells. So in this picture, these are the NETs, and that's the sell that threw them out. And what happens is they literally catch the bacteria and viruses, and they were killing them in to. And they -- if you add a huge lethal dose of bacteria to your blood, these NETs will clear it in minutes. Your blood will be sterile again. So without these things, although nobody knew about them, we all wouldn't get to our first birthday. We'd die on our first infection. So they're hugely important, and this is a picture from our own website. Here's a cell ejecting NETs. Here's the bacteria then this caught. But the point is that chromatin and chromosomes are made of nucleosomes. So all of these NETs are -- we're doing the wrong thing. All of these NETs are basically long strings of nucleosomes. And we've spent the last 10 years developing really good nucleosome assays, which means that we have now the only valid measurement for NETs that actually exists. Here's a picture that we've taken actually with our own antibodies. Here's a NET release from a cell. The cell was there, and this is the NET -- and this one, I particularly like because here is where the sellers and here's the NETs that are being released from them. But so that's a huge part of the immune system, but they have a dark side. And they contribute to a huge number of pathologies in all sorts of areas in disease, including things like sepsis and COVID. And it's really COVID that precipitated the opportunity for us. And it's really COVID that has made the world -- the medical world wake up to NETs. But as I say, it's relevant in many, many disease areas. So why -- what do NETs do in COVID? Well, first of all, if you catch a virus, your neutrophils will go to that tissue, in the COVID's case, that's the lungs, and then they get produced in response to the virus. If you make too much NETs, which a subsection of people do, then you end up -- too much NETs leads to a positive feedback to loop with something called cytokines, and you end up with something called a cytokine storm. That needs to further production of NETs. You get a terrible positive feedback loop so that your lungs and your vessels get filled up with NETs. And of course the NETs are toxic, they're designed to kill bacteria, and they will end up killing the linings to your own vascular system, and they will end up killing the cells, and damaging the cells in the alveola of the lungs. And what happens then is that the lungs lose permeability and you essentially drown in your own body fluid, and that's the basis of essentially what happens to you in COVID. In other diseases, you can get multiple organ format -- failure. So similar things happen in other organs. So very shortly after COVID started, people in our company, despite my huge brain, it wasn't me, realized that this was a huge opportunity for us. And the first thing we did was to just work with -- this was actually done with a hospital in Munich, was to look at different COVID patients in different wards, and how does -- what happens when we measure their NETs levels. So on the left here, there's people that were tested at outpatients. So that these are all PCR-positive COVID patients at the beginning of the pandemic when COVID was really hurting a lot of people. They've got slightly elevated levels, but near normal. And then some patients were admitted to regular wards. So these are patients that are sick, but they don't need organ support. They don't need ventilation and so on. And they're elevated. And then we measured some people in intensive care. And all of those were very highly elevated, even further above those in the regular ward. And moreover, all of the 4 people that had the highest levels actually died in intensive care. So we immediately realized that this is potentially a very good tool in COVID and sepsis. We then went on to do a study. This is actually a study in King's College, which is a huge hospital in London. And what they did in this study was that they looked at the levels of NETs, measured with our test again, on admission to the hospital. And what they found there was that people that would go on to be fine in regular wards and would not need organ support had these levels of NETs up to about a bit under 2,000. The people that eventually did need organ support and went to intensive care, in general, had much higher levels. So the difference between this and the last slide is that the last slide shows an association. This shows a real prediction. It means that on entrance to the hospitals, you can predict who is going to need organ support, and that has huge value. The lower graph is the people that did go to intensive care, and those with the highest levels of all were the ones with the highest mortality rates, in the black bars here. And then that correlation lasts for about a week or so, and then it's lost. And the reason it's lost is because the very, very sick people are actually losing the potential to make NETs at some point. So I think this was a really fabulous piece of work and shows where our opportunity lies. It's not going forward. Oh, there it is. So I wanted to give you a couple of other sort of left-the-field examples of what we're doing, just to show the breadth of the opportunity. So we have an opportunity here in companion diagnostics as well. And because NETs are recognized as such a huge potential, whole new area of medicine really moving forward. There are now quite a few companies that are developing therapeutics, specifically targeted against NETs. And this is an example. This company is actually called [indiscernible]. We're working very closely with them. I work incredibly closely with their Chief Medical Officer. And they've got a device that removes the NETs from the blood, and I won't go into details how it works. But this -- but they, after trying virtually everything that there is to try, they have settled on a partnership with us because they say that ours is the only assay that actually measures NETs properly. And what we have here is -- this is actually in a pig model of sepsis. So the pigs are injected with massive doses of bacteria over several hours, it's just infused. That induces sepsis, and then this plasmapheresis is their treatment. And the open bars here are pigs that are untreated. So they get the bacteria, but they don't get the therapy. And so their NETs levels is just rising and rising and rising. And the pigs that are treated it rises and then flattens off. And this is all using our tests, and I won't bother with this one. This is looking at the blood that actually comes out of their device. And you can see in that case, that the untreated pigs is an empty device as opposed to a full 1 looks pretty much the same as this. But actually, the blood coming out of their device has more or less nothing in it, which is great for them and also shows how well our test measures that. Just as a matter of interest to show the potency of how NETs effects in sepsis, the pigs that had a sham treatment, so no NETs removed, this was the level of noradrenaline required to keep their blood pressure up because if you go -- if you get sepsis, you go to shock, your blood pressure collapses, that's how you die. Several of the pigs that were not treated, died. All of the pigs that received the treatment, if they were humans, they could have come out of intensive care. They were fine and the amount of noradrenaline required to keep their blood pressure up, was less than 1% of required otherwise. So NETs is -- NETs therapeutics have a huge potential. And the only way that people will partner with [indiscernible] is if we're also involved because you can't treat somebody for NETs if you don't know if they've got any. And then I wanted to show you 1 further example because for me, it's the most exciting one of all. And when I first heard about it, it sounds crazy, but it's true, and there's a lot of stuff in the literature, which I can send to you if you're interested. But it's an amazing story. So NETs are also mechanistic in the spread of primary to secondary cancers. And remember, nobody -- generally speaking, nobody dies of primary cancer, you always die of secondary cancer. So if you can prevent the spread, that would be a huge step forward in cancer generally. So why are NETs interesting in cancer? What's been shown by a lot of people now, and none of the words on this slide are mine, they're all from scientists and clinicians is that when a cancer grows, it grows in an inflammatory environment surrounded by neutrophils and surrounded by NETs. And they adapt to the NETs. So the NETs should kill things, but they adapt and they survive in NETs and they thrive so well that they become covered in NETs. So this green is the NETs, this is a bunch of cancer cells. These are neutrophils that have come -- made some NETs, completely covered the cancer cells. And once the cancer cells are covered in NETs. So in a normal person, we develop bad cells every day, but they're all killed and eaten by white cells. But once you're covered in NETs, the white cells actually can't get to, and the NETs act as a shield or an armor and protect the cancer cells from attack from the white cells. And that is mechanistic in the spread of secondary cancers. Because once these cells fall off the main cancer, they can then literally travel around the circulation in the blood. And the NETs is effectively a taxi. They're wandering around the blood circulation with immunity, impunity, and then get lodged in the lung or liver and start secondaries. So there's a lot of clinical work that's already been done in people, and this isn't a science lecture. But I think that whole story is hugely powerful. I think it will play a very large part in cancer moving forward, and that our diagnostics will play a very large role in that. Towards that screen and then we're done. So that's a very interesting story on 1 level, what's it got to do with us? So first of all, I think as I said at the beginning, we've been developing assays for nucleosomes and NETs now for a decade. And I can -- I've developed dozens and dozens of these sorts of tests for different things. And I can tell you that developing them for chromosome fragments is far more difficult than anything I've ever done in my life, and I've done quite a lot. But we now have developed analytically valid tests, right? And they work. They require minutes to complete, and they are the only analytically valid test for NETs in the world. To my knowledge -- but not only to my knowledge, we've talked to quite a few different new NETs therapeutics companies, and we're the only test that any of them are interested in right now as well. They agree that it's the only one that works. We're already partnered with a therapeutic company but for a companion diagnostic use. And we're working with a lot of high-profile big hospitals in Europe, and now in discussion with some in the U.S. as well. And I do believe this is going to be a huge medical area. And we have 4 formats for the test. So the first format we developed was a manual test, which is great for research use, great to send to hospital and get them to find out if it works. But it takes 5 hours to do for 1 person to measure a few samples. It's not going to be a big product. We've now got an automated assay, which works in 45 minutes. You literally just have to press the button. So that is a more realistic product. But along with that, that requires a dedicated instrument. So if the hospital down the road in New York is going to do our test, on that format, they need to buy a new instrument, which is not hugely expensive, but it is a barrier. What we're developing now is this test, the HIA test. What's special about that? Well, first of all, it will complete in less than 10 minutes. But most importantly, it works on every clinical chemistry analyzer, the bog-standard ones that measure urea and glucose and cholesterol. That exists in every hospital in the world. And then all we have to sell is a box of bottles and every hospital can do thousands of tests immediately on an installed worldwide hardware base. And as Gael was saying, that's our eventual aim is that we can get market penetration without anybody buying any instruments, whatsoever. This is -- this doesn't exist today, but I'm expecting that it will be available in research format, at least this year, a little -- in a few months, and we will be putting that into hospitals to test it very soon. The last format is the format that Tom talked about earlier, and that's a Point of Care test, and that's a very small machine that can be in the vet's office or the doctor's office and you get a result right away. So I think this is -- so in summary, it's a very exciting area in addition to what we're doing at the moment. And we're not just doing it. We're also protecting it, of course. And as Cameron said, I've written some of these patents myself. And a lot of the recent focus has been in protecting this unique opportunity in NETs. Thank you. Sorry, I'm not doing my duty. I'm going to hand you over to Sharon now who has a larger brain than me, and is looking after our regulatory affairs. Thank you, Sharon.

Thank you, Jacob. I'm going now. Perfect. My name is Sharon Ballesteros. And no, my brain is not larger than Dr. Micallef. And I recently joined Volition just about a month ago, a little over a month ago. I come from a background of IVDD diagnostics. I've been in the business for over 20 years. And I started with a company you may have heard of called Siemens, which is very prolific in putting out a lot of diagnostics products. I've been in some smaller companies since then in different sizes. My last one was with a company called Grail. I think a lot of you have probably heard about that one as well. And I'm really, really excited to be joining Volition to help get this strategy, get this product to the market in an FDA-approved product. That's my thing here is to really get us into that clinical product development. We're poised. We're ready. As Dr. Jake said, we've got a product that's analytically valid. We've got a product that is now ready to go into the FDA market with the right clinical studies and so on. And I'm really excited to be here at this point in time in Volition's growth to do that. As Dr. Jake said, we have the manual one, which is an ELISA test that is going for IVDD clearance this month. And then we're also doing that on the automated 1 test with an IVDD clearance this month. So our regulatory path in Europe is well underway, and that's a solid basis for us now to go into the FDA market. We are also working on this HIA platform for IVDR in Europe. When it comes to the FDA platform, we're building on the solid technology we already have. We've got clinical evidence that this thing is going to work in multiple areas. And we've got 2 key areas that we're focusing on. Sepsis, as you've just heard, is a huge market for us. It's a huge potential for us. We do have some clinical evidence on that. We're doing clinical trials on that, and our goal is to do a breakthrough device designation request with the FDA. The FDA is looking for clinical utility. So our Europe product is a good quantification of nucleosomes. How many do you have? Is it good or bad? For the FDA, we need to have a disease state. What disease state are we working towards? So the clinical utility for sepsis is huge, and it's got a big market for us, and it's one that we feel that the FDA is going to say, yes, that product is needed. That's a breakthrough device. Then we're also working on NETosis. We're going to narrow that down somewhat through our clinical studies. We've got clinical studies that are starting in the U.S. in this summer. Actually, very soon, we have some clinical studies starting. And then we're going to take those to a pre-submission to the FDA, and we expect those to be a 510(k), which is one of your easier pathways to FDA approval. Time -- I don't have the time lines on that. So basically, the time lines on these are the breakthrough device designation is at the end of this year. It's usually 60, 70 days that you talk through the FDA. You get your clinical utility approved, you get your process going. And then you start your clinical studies, your clinical validation studies, and it takes a couple of years sometimes to get those through. The 510(k), if you're looking at NETosis and so on, some of those competing cancers and so on that Dr. Jake talked about, take a while to get all of that clinical data in hand. So we're looking at that in the first part of 2023 to get all that data in hand, then that's a pre-sub to the FDA from there. That's our clinical validation. So that's when our pre sub to the FDA goes in, maybe a year or 2 after that. So we feel like there's a really good pathway for this product. And I'm here, I'm confident, I love this company, and I'm just really happy to be here, and I'm so excited that we're moving in that direction, and dedicated to this. And I have to go back 1 step. Why am I here? Everybody has been asking me that. The first part of the presentation, you heard Dr. Tom talking about saving lives. And you hear that, and it does it tears at your heart when you're doing that with pets. It also tears at your heart when you're doing that with people. This company is dedicated to saving lives. To me, that's a difference maker for this company. It's really saving lives no matter whether it's animals, people or whatever. And that's one of the main reasons I joined. I'm going to turn it over now to Cameron. Thank you.

Thank you. Thank you, everyone. I'll just start with commercialization strategy for NETosis. And I think a very, very good introduction to how we start that from Sharon, obviously. And I think the simplest way of going through it, I think the first question everyone asks, and it's a good one, and we're all very busy, but how do you do all these things on such a small budget with such a small team? We've spent less in 11 years, then the big boys, you know, do every single quarter. We do that because we have a very special platform. It is very low cost. And I think the very important thing to remember is the same platform of the chromatin fragments, which Jake talks about measures in animals, acute cancer in dogs, cats, in humans, NETosis. And NETosis, as you can see, is incredibly important and also the very exciting capture program, which we didn't -- not even going to discuss today, but huge potential in that as well. So each one of those helps us across the range. So we've learned a lot from launching Vet first because the vet side -- and we've done it the way we've described. We've taken on a fantastic Vet team. I think we've all got to be very impressed with everyone. You've seen from the vet team, how committed they are. How much they know the space, what they're doing. And the commercialization strategy, Gael, so well [indiscernible] what we do. I think it's a fantastic strategy. The basic strategy is, and we do the same for NETosis is basically develop the platform, have a fantastic portfolio of intellectual property. Because we've taken 11 years to develop this fantastic platform, we really dominate what we do. And then we also don't just want to license. I think anyone who's been involved in this business can often sound great, but you end up with not much at the end of the day. So we've got a hybrid model. Our intellectual property is extremely important. So we need to give people the access to that otherwise they can't do it. But we're producing the key components so that provide them to whoever wants to -- for example, to Heska, we're providing the kits or the key components. That's good for us, good for them. It's good for the buyer because they don't have to reinvent the wheel. It's taken us a long time to develop these key components. But it's good for us. I always use an analogy, if you have a plan for a car rather than just licensing it out. You don't know how many they're making what's going on. We license the technology, but also provide the wheels. So you know how many they're making. You can keep track of what's going on. You get paid upfront. So you're not waiting for a royalty statement 2, 3 quarters, which will make our CFO very happy. And so our model, I think, is very well thought through, and it's shown to work very well in the vet space. So -- we developed technology launch, so prove it works, like we did with the beta launch in Texas, that gets the big companies interested and then we license to them on the model where we get large upfront payments and potentially absolutely massive payments throughout the life of the product. Because every time someone sells a product, Volition gets paid. And up to $10 per test for the dealers we're looking at. When you're only looking at $20 or $30 to the vet, that's a big percentage of what happens. And it's big because we provide fantastic components. It's a breakthrough product. Nothing else out there does what we do, and how we do it. So I don't think there's any need for a large sales force in anything we do. There's no need. We have some great marketing puts some great production specialists, we're looking at a small team. So that means you can grow very fast, very quickly, worldwide. And it means you don't have large CapEx or capital expenditure. And our OpEx, and it means you can keep very, very virtual and keep the burn rate down. I think we all know a lot of companies that have burned hundreds -- or more than $100 million every quarter. It's not something we ever intend to have any need to do. We can save a lot of lives, sell a lot of products without any of that. So when you say what's the market? How are you going to deliver on the NETosis? I think that's exactly the same. I think you can't help me impress with the potential after you listen to Dr. Micallef. It basically boils down to -- I think I always like to look at things personally. Would I want to know my NETs level, I was in a hospital, absolutely. Would I want my mother or father, absolutely. And it's not something you want to take once. Sepsis happens because it hits you really quick and hard. So I think particularly intensive care, particularly if you're in hospital, you want it every day or several times a day, that means the testing, the volume of tests. And that's what we're all about, helping as many people as possible make it a high-volume test, still at a great margin for us to make it very affordable, very democratic worldwide. And I think doing that, we can do the best thing by all the people in the world, and the best thing by our shareholders. So it's a great virtuous circle. And that's exactly how we intend to commercialize everything we do. And as you can see, there's a lot of potential in all of that. So concluding, first of all, thank you, everyone, for coming, and thanks to the webinar guests as well. Can't forget those of you are at home. I couldn't be happier or proud of where we are, and thank you. This has been a great opportunity. We're shifting gears as a company, and it's very, very important to get that across. We have a fantastic wave of products coming through on the same platform. We're keeping our costs down. We're listed on a fantastic exchange. I think it's really going to be a fantastic couple of years for us. And it's a credit to the team. We have a fantastic team in Belgium, in the U.S., in Asia, and we worked a long time to get all of this done and a company really is about its people. We have a fantastic technology, but without our team, it absolutely would not have happened. So -- and I think we've delivered something very, very special. I think we've got a very special few years ahead of us. And thank you for your time. We have other potential events coming up where we'll describe more the new NETs the webinars. Also, we'll have other Capital Markets Days, probably. And of course, our regular earnings calls as we really get through the process. And just to -- sorry, the slide -- I was a slide behind. I think I've covered all of that. Just to hammer home the issue of what we have, revenue from each test. I think the milestone payments are fantastic. We made our CFO very happy to have around 60% of the spend in the next 2 years, covered by milestone payments alone. That's a big move from where we were. This, again, is purely number of tests sold, how much money would Volition make. So -- and the line -- this is just for the vet test that we have launched alone. So just think about all the stuff you mentioned, none of that ever happens. None of the other products capture NETosis, which I think is highly unlikely. But if this is the only test is used in monitoring and detection in the dog space, not including cats, just a few million tests a year, which is where we expect to get to in the next couple of years. This one test alone makes us profitable as a company, every -- not Volition Vet, Volition itself. And 30 million tests per year, I think is very achievable. There's 22 million dogs in the U.S. alone and many times that internationally. And the 2 million dogs who get this cancer could have the test 4 or 5 times when they're monitoring treatment. So you add all that up, the $10 million, $20 million, $30 million is certainly not out of the question in a few years' time. And that makes us a very profitable company. And I think something in the liquid biopsy space, in the cancer space, it's something to be so close to profitability with a product that's launched, huge pipeline on the same platform right behind it puts us in an unbelievably strong situation with the team that we have. So look forward to updating you all in the coming months and quarters. And again, thank you very much for interest in Volition. Thank you.

Thanks very much, Cameron, and to all our live presenters. I'm afraid you haven't finished yet. You're going to have to sing a bit more for your supper. So if you guys could come and sit down. We actually have had quite a few questions coming online, but I'm going to give our live attendees first bite of the cherry. Sorry with all these metaphors. But I'd just like to say, food for thought there, Vets, NETs and everything else. Do we have any questions from the floor? If you're prepared to give your name and your organization, fine. If you're worried about that, don't worry, but we have a hand up straight away. We got a microphone coming around. Scott will rush around that...

like a flash.

Testing. Okay. First of all, thank you, Cameron and the Volition team for hosting this great event. We're glad to be here. I'm Nathan Weinstein, Head of Healthcare Equity Research at Aegis Capital, really interesting presentation. So I just had 2 questions, and this is on the Vet side to begin with. First of all, I was just wondering if you could opine about how earlier cancer detection could change treatment protocols, will we modify vets behaviors? And how that could lead to better outcomes in terms of canine cancer? And then the second question, you said something very interesting, potentially achieving like 90% market coverage. Just what percent are you getting from Heska? And then how do you go from that to the 90%?

So 2 questions. Who wants to start the ball rolling? Gael?

I'm going to take actually -- probably both, but the first one would be better suited for Tom, but I'll -- I'd like to start. So the -- what was the -- can you repeat the first one?

Yes. How earlier detection of cancer can -- change of that behavior.

Yes. So we know -- and it's the same for animal, that's the earlier to detect the better the outcome. And there are quite a few companies that are usually it's transplant from a human or brought from human to the animal side. But we have now a bunch of companies coming with animal dedicated cancer treatment. So again, this earlier detection combined with those new companies come on the market. We believe it's a vicious -- sorry, a positive circle that is going to feed over itself over the next decade, where earlier detection will help them sell more, get better outcome for pets. The word gets around. That means people want to be screened earlier and so on. So yes, I would not go further without Tom being in the row.

Can I [indiscernible] to that? I don't think to that -- it's not an answer, but I think it's relevant is that, in the vet space, there's even less available than there is in the human space, and there's not a huge amount available in the human space. And then on top of that, vets have an additional problem in that because there are no blood test really at all, currently. The only option if you have a suspected cancer is scan. And of course, you can't ask a dog to lie at bed still for 20 minutes in a scanning machine. So that also means that you have to have a general anesthetic. So as well as helping to detect the cancer earlier, it means that if you have a suspected cancer, you've got a realistic blood test to rule in and rule out without necessarily giving a general anesthetic, which can never be a good thing. And then -- and of course, that -- the relative cost of a scan with the general anesthetic compared to a low-cost blood test is astonishing. So I think it's not just a question of earlier detection, although it is, it's also a question of just easing the whole process for the vets and the dog.

Cameron here. Just 1 point to follow up on as well. That's obviously a question I asked early on as well because that's the key. So both Tom and Heather, can absolutely answer that vets with the decades of experience between them. And their answer was 15 or 20 minutes each. So, I'm not vet. I'm not going to embarrass you with my non-vet answer, but very important to detect early like in humans. And part of the issue is there's been nothing which can detect early. As Jake said, you can't scan an animal. They won't tell you they're -- so you have to tell -- look at them when they're very sick because they know. So it's a very important for early detection. But we can certainly get that question answered by of the vets with decades and decades of experience, but the answer is absolutely very important to detect early.

Nathan, there was a second question there. Because of that full some answer, we need to remind you of the second question, please.

The 90%.

Yes. Yes. So how do we get to 90%? And then we have Dharmik in the room that can help us exactly with the numbers. We also have a representative of Heska. I would not want to put him on the spot, executive market share. But we can get into more details about that. I would say our understanding is the is also quite different between the U.S. and Europe, and we have a very aggressive European strategy. That's 1 thing we like. It's a growth market. But how do we get from -- in the U.S. alone just from where Heska is to a broader -- or 90%. It's quite simple. We sign additional large distribution and partnership agreements, and you're going to hear more about that in the short -- short future.

Happy? I'm going to take a question that's coming, but this is an idiot's question, Sharon, okay? But the good thing about people like me is I can sometimes ask idiot's questions, and some of these guys say, thank God, you asked that question. IVDD is that a European -- does everybody know what that is or maybe just tell us a little bit more about that.

I don't believe there is any idiot question asked.

Right. Okay. That's the right answer.

Yes. There -- that is the European designation for CE marking that is currently in place. So it is a CE-marked product. And then IVDR is what's coming after -- like at the end of this year and so on. They're changing the regulations a little. It's just the nomenclature for the regulations guiding, getting a CE mark. So these will be CE-marked products.

Great. Thank you.

[indiscernible] On that timing, which was on the slide, we expect to have a CE-marked for NETosis in the next few weeks because May is look at calendar, we're in May already, Friday, the 13th. Looks very auspicious. But so look forward to some information on that soon. Now CE mark means you can sell it. It is made properly. It does what it says, very broad claims. It does not necessarily mean anyone is going to buy it quite yet. So the strategy is a little different in Europe from the U.S. The U.S. FDA, you have to prove everything before you get it approved. In Europe, you prove it and get it properly made our plan because of the very broad use cases. I think Jake pointed out, if you add up steps metastasis cancer [ COVID ], and that's a lot of the -- it's all tragic percentage of how we meet our ends. Very, very broad uses for the assay. So we get it approved. So then the trials are then done with the commercial product. And then -- so we're working with a lot of fantastic key opinion leaders in Europe. People who have reputations in their field, all the fields Jake mentioned and quite a few more. So once the products is CE marked, which is very soon. They can then run trials with the products. Whenever that trial is finished, they publish that's when their peers start using the test for that purpose. So that's why we're very confident. I do not expect to see a lot of revenue on the CE mark initially because you have to show the use cases beyond the smaller work we've done on the very broad claims. But as Jake pointed out, there's a huge number of use cases, and we'll be doing small, medium and larger scale studies with groups who can be using the actual product for the trial. So once they're finished, then it can really take off. And given the fantastic production we have of the controls and the antibodies and the key components. It can grow more like a software company because we can get out there quickly, particularly if we're on HIA or the other platforms, it can grow like wildfire because they're already installed everywhere. We can mass manufacture key components. And I can't say enough. NETosis, you haven't heard much about it, neither have I, not surprising. It is absolutely key and measuring it is incredibly important. As Jake said, you're not going to remove it or unless you have too much of it. And if you're being treated, you want to know if it's working, and you want to know if it's going up for all those reasons is going up. There's no good reason going up. You don't want metastases cancer, you don't want sepsis for those reasons. So this, I think, could be an absolutely massive part of what we do. And you think the vet market is big, which is very large, NETosis could potentially be twice as big.

See. I'm glad I asked the question. It's too bad.

Yes. That wasn't the stupid question.

Would you bear with me 1 second, sir. I'm just going to give our online guests a quick mention. It's got nothing to do with these guys from the U.K. where I'm from, no biased there. Michael is one of the long-term investors in the U.K. First of all, the reason he's coming on next is [indiscernible] very informative session with the sums up. Thank you, Michael. Question on NETs. In years and months, how far ahead of your competitors do you think you are in terms of having a NETs test approved by the regulators. So it kind of moves on from where we've just been talking about. I'm just going to take that easy question. Jake?

Well, thank you, Michael. We expect to get the NETs test approved in Europe this month. And to my knowledge, there is no other commercial NETs test even in development yet. So I think that puts us years ahead. The only realistic current alternative that anybody has is to measure cell-free DNA. That's not technically valid. But in addition it takes more than a day, probably takes a couple of days. It costs much, much more money apart from anything else you have to do with DNA extraction. And then -- and so our test is ahead in regulatory terms, by, I would say, years. And the leading alternative cost much more money takes several days to do, and is less informative. And of course, it's not useful because especially in terms of sepsis, sepsis can go from being -- the patient can go from being in not too bad a condition to potential death within hours. So you've got a test that's going to take a couple of days, that's not really helpful. So I think that we really do have a very strong head start in the area. And moreover, because we are first movers, we've also been filing IP. So I think we have a very good position moving forward.

Cameron, brief one here.

Yes. Just a brief one. And don't forget -- so not only are we the first, not only does it work very well and there's not much of development. We have a fantastic advantage because of our business model, keep it -- keep it affordable, get it out quickly. If you're trying to finance another -- as a business side, if you're trying to finance another test that's more expensive and more complicated, doing that when you've got the market leader, which is not going to be a cut on price certainly, nothing on accuracy. And once it's already all out there, I think we've got a very strong position as the first mover. But I think that's another very strong part of being -- keeping it at very low cost, very approachable and very democratic. It's very hard to get around a test like that. So I think we've got all the cards in our hands.

John? [indiscernible]

Can I add one thing?

Yes, please.

Which is that the just to sort of give us a bit of flavor of what it means. The device that I spoke about on my talk, that's not our device, the device that removes NETs from the circulation. The FDA gave that breakthrough device designation a couple of weeks ago. And so the FDA clearly also recognized the importance of this whole area and the importance of NETs therapies going forward. And of course, their device can't go forward without some sort of measurement system. And so I think we will get breakthrough device designation also. And it's going to be -- it's going to take a lot of catching up to get back with us.

Yes. And I actually believe that our technology with what Cameron was saying, this is a very basic chemistry technology. It's something that the FDA is familiar with. Antibody technology has been around for a long time. So this particular technology is something that's going to be much easier to get through a regulatory body than some of the more complicated next-gen sequencing or those types of artificial intelligence. Those take a lot longer to get through a regulatory body. Our technology is low cost. It's not as complex as some of the others. So that's one of our advantages here.

Okay. So you've been very patient. Thank you very much.

Jeff Bernstein from Cowen. So you've made a pretty persuasive argument that the veterinary opportunity in and of itself make the company a large and very profitable company. It sounds like NETs, if it's anything close to C-reactive protein test is another huge, huge opportunity. So what are you doing in terms of capital allocation now? You've had lymphoma, lung, CRC tests that you've been doing studies on, et cetera, needs you capture where is the money going to be spent now going forward?

Yes. Jeff, very good question. So just on C- reactive protein, that's a very good 1 to mention. So if you look at our graphs, 100 million tests is where we can get to kind of $1 billion in revenue, C-reactive proteins and inflammation market, and that's exactly what it sells. That's 1 marker for inflammation, everyone -- everything else. So if you look at those numbers and think, wow, that's -- this is pretty easy to the bottom end of where we end up in 5 or 6 years. So allocate capital. So I think best way to answer that is the actual platform itself is where 80% of the money goes to. So because -- what's important to remember, the Heska is a Point of Care. That same Point of Care can be used in the human side, Nu.Q Capture, Nu.Q NETosis can also be used in animals. The capture program itself uses the same antibodies. The same need for everything we do. So we spent a lot of time and effort on our fantastic Belgium team, and I'd love to thank you to all of them as well. There've been some of whom have been with us 10 years, doing all of that work. So we allocate the vast majority to the platform development and the rollout. And then, for example, the vet side, it's actually cost us very little to launch the products because it's the same assay, the same performance, everything is the same as the human side. And then so far as NETosis, again, that's 5% or less than what we do because it's the same platform. We've taken on -- the extra cost often comes down to the team members. You've seen the great sitting next to anyone as well, even there and on the vet side. So new team members, there's a lot of what we do, but there's not any extra capital, no extra anything for all of what we do. But I think it's very important to have dedicated teams commercializing. I don't know the first thing about the vet space when I started. Tom is 70 years old, and he's a legend in industry. He can do way more help than I could ever do. So -- and I think we're doing the same on the NETosis side. Remi came on a few month a year ago, his exploration as well and knows the space very, very well. So I think the majority of the money for that will be on the team and the rollout, but that's great money to spend because no one mind you spending money on product launches. And I think you'd have to say that Vets' been a fantastic success. It's now a profit center for everything else. Where 2 years ago, people said, oh, is it a distraction? What are you doing quite rightly because there was so much going on. So I think NETs going to be a very positive for us cash flow wise within a year or 2 as well with everything we do. So the short answer is the vast majority goes on the platform and the platform itself. And then we're spending money on the teams to commercialize each one. And if Capture does get to the level NETosis now, we'll start hiring dedicated team members for that. And you mentioned the other cancers, it's probably just a good little segue. So while the pandemic has been on and the trials were paused, nothing we can do about that. Understandably, people don't want to go to hospital several times for a trial when things are the way they were. The focus of the public side was very much on Vet and NETs because everyone, I think including yourself, said, what's the revenue plan, what's happening. Absolutely. But we've really put some revenue and some resources back into cancer, but we're focusing in the human cancer, focusing on the Capture program. Because I think there's a really good chance. We can skip a generation or two the very basic platform we have works fantastic on the vet ones we have, works fantastic well on NETosis. But the solid tumors where you really want to them pet competing with the very accurate test, which -- I won't mention the names, the companies be who they are, the big ones who have come out. I think the promise of Capture, and we should have a lot more information through next year is to be more accurate -- as accurate or more accurate than those guys with a lot less work and a lot less cost. So we have put some resources in that. But again, that was mainly people. The Belgium team has been working on that very well. And we've also added on to that Southern Californian team on the cancer side. So think about it, platform and then teams to commercialize and develop. And I think it's worked out very well so far.

Thank you, sir. Great question. Thank you. We go back to our remote guests, and we have Bruce Jackson of the Benchmark group. Again, getting us right in the good place here, Fabulous presentations, guys. His question is the idea that metastatic cancer cells are covered with NETs is interesting, quite interesting. What information would a test for NETs provide to oncologists? And what would they do with that information? It sounds like a question for Mr. Big brain.

Okay. Well, thanks, Bruce. I know Bruce quite well, and he always ask good questions. So -- and the hard ones. So what would you do with the information on NETs in a cancer case? Well, there are already studies going on in humans where people are looking at the level of NETs at surgery. So there's papers out there about removing liver metastases and then correlating the level of NETs on -- at -- just before surgery, actually, with the length of remission following surgery, and there is a correlation. So there is a correlation between the amount of NETs you have and how long you're going to have a disease-free survival after surgery. So there are actual human studies going on as well as there are many, many academic studies in animals and cells and so on. So I think an example of what might happen in the future, and it will sound a bit fantastic now, but I think that it might not be too far away is that somebody is having surgery for a primary cancer or a secondary, it doesn't matter but it could be both. And you measure the NETs level prior to surgery. If your NETs level is elevated, and maybe even if it's only fairly moderately elevated, you provide a NETs therapy to that person to reduce the level. Because if the NETs levels are high, actually during the surgery, you're actually potentially helping the spread. You could be accelerating the spread during the actual treatment. And to give an -- there are other examples, not -- this is not the only example. But to give the -- extend the example that we were talking about earlier with the company we're already partnered with. If you have a binder, which their technology works by binding the NETs, so it will also bind cancer cells covered with NETs because it binds NETs. So you could remove all of those circulating tumor cells out, actually during -- because people are apt machines during this surgery anyway. So you could remove it before the surgery, and during the surgery and thereby limit the spread of cancer actually during therapy. And then on top of that, if you've got a Stage III primary cancer, which is -- and it could go Stage IV. You can measure the NETs and say this person is in serious danger of actually spreading to Stage IV and getting secondaries, this primary -- it's a big primary, but actually, it looks like it's going to stay put where it is. And so you could stratify patients for treatment according to their level of risk of developing secondaries. And then, of course, if you treat those people and remove all the NETs, as I said, you'll be removing the cells that would cause the secondaries as well. So there's huge potential for treatment in cancer. And at the moment, I have to say -- because we're in a public forum at the moment, all of this is fantasy, but I think that the reality might not be too far away.

Great. Any more questions from our audience before -- just yes, we have 2 here. Gentlemen, I'm just going to once we take the microphone over to you, I want these to be really quick-fire questions. Okay, guys, a couple of sentences. Quick fire answers. Who are your competitors in the cancer test for dogs, and how do you differ?

I can take this one. As far as we know, there is only 1 currently that is positioned as a potential competitor. I won't name them. Can I name them? [ Pediax]. We -- on every criteria, we are better than them at the matter in terms of turnaround time, in terms of accuracy, where kind of in the ballpark, in terms of turnaround time in terms of cost, in terms of ease-to-use, we're better and where -- in other word, I'll just say 1 last thing. Their positioning as a screening, we believe that's probably a really good second stage, you do our test. And then after that, there would be a great second test to do. They're trying to do what they're doing in human try to give those very expensive test as screening to everyone, but it's really difficult in this environment. So that would be the one.

Great. So we have 2 gentlemen that sat next to each other. Sir?

Ross Osborn, Cantor-Fitzgerald. So just be curious to hear out of the 80 million dogs in the U.S., how many of those dogs are actually being taken to an annual checkup? And then as a follow-up, what would be the frequency of use of the monitoring test?

So for the first question, I don't know if Dharmik, can you can take it? Dharmik is just behind your head in there.

If you just identify yourself first.

Yes. So, I'm Dharmik, I'm heading Business Intelligence at Volition. To answer the first question is I will give you a rough ballpark figure is around 20%. It really depends on the age of the pet as well. So younger dogs are slightly lower, but geriatric drugs are much higher. So kind of you have to break that on in terms of number, 20%. So over to Gael the second one.

What was the -- sorry, what was the second one?

Just the frequency of use of the monitoring tests.

4 or 5x.

Yes. It could vary from 2 to -- frequency for the screening or the monitoring?

Monitoring.

For the monitoring 2 to 4, 5. It depends on the length of the treatment. And then you go into remission and then it would be every beginning a little more and then after that, after 6 months probably.

2 million dogs and 4 or 5x on the underwriter.

Okay. Great. And then just quickly on the NETs side of things. What do you think the size of the clinical validation studies will need to be for FDA approval. And then with that particular disease, is there any particular challenge with enrollment that you're going to have to face? Or is that [indiscernible]

So the size of the studies is still TBD. We're still working through some of the earlier studies on this, the clinical studies. So I really can't give you a good answer on the size of those. Current budget, roughly south of $4 million on clinical studies, I think, is what we're at right now. There are particular challenges when you're trying to differentiate different types of cancers. And this is quantitation of nucleosomes and trying to differentiate between competing diseases and so on. When you're looking at getting cancers in, that is a longer time line for getting enough patients in with all of the competing diseases. When it comes to sepsis, that's a pretty clear-cut outcome. So those studies are actually shorter. So we're doing parallel paths right now. But at some point, we're going to at the breakthrough device designation time line at the end of this year. We'll see where we are on both of those. But the sepsis patients are, yes, much faster to get large numbers in.

And your neighbor has a question as well.

Michael Luo with IF Capital Management. I had a question about the opportunity for companion diagnostics with the NETs product I was wondering if you could elaborate on what the pipeline of therapeutics looks like that you could act as a companion diagnostic for. And if it was possible to maybe quantify the revenue opportunity for example, if your current partner receives FDA approval into selling the product through.

So we're talking to basically several groups because I think, as Jake pointed out, I think we have the best/only test that really works. And so we had a lot of groups come towards us. There are several ways of doing it. You can have apheresis, which clears the blood out. You can use DNAs to kind of drop it up. And look at all the use cases. I mean, if any one of those needs a therapy, and you have to have the companion diagnostic for it, we haven't put out the guidance on that, but it's clearly just huge. The testing itself is your NETs going up or down is -- I take every time I've got the doctor in a hospital every time intensive care every few hours. And as a companion diagnostic. I think if you add all the treatments for sepsis, all the treatments for COVID, metastasis cancer or the organ work, it's going to be really big. And we're not looking to hold in on over a barrel just because we have the best in the only test. We really want it to be used by a lot of people. So we're going to keep our model of keeping it affordable. And so it's something routine, the doctors can just do very, very regularly. We're not talking about the size now, but it's -- if you imagine add up all those markets. It's another elephant in the markets we're after. And if you look at NETosis overall, we think it's about twice the size of the potential vet market, which is potentially $11 billion a year as the TAM. So very, very large.

Great. And on that market, is it -- are there any like very late stage on the market treatments or is it mostly early stage stuff like your partners involved ?

I think it's early stage?

Yes. They are all early stage. There's a few that have very good proof-of-concept and that entering human clinical studies, the one that I talked about entering human clinical studies now. But -- I can't speak for them but I would have thought that there realistically it could be an option in Europe in 2 years 2 years. May be a bit longer than U.S. as i said It has got brave from the device designation in U.S. so I would like to put a prediction on it but it's that sort of time and wait.

Okay great. And then on the vet side, one more question. I was curious if you have a sense of how many tests are done currently on Heska's Element i+ platform, like how big that platform is currently?

Actually, we'd have to take it and get back to you. Tom is not here, unfortunately, he couldn't make it, but we'll -- we can get that information to you from Heska. I wouldn't want to guess. Thank you. Sorry.

Tom is actually listening, but we can't patch him in at the moment. So he will be, as you speak, probably writing down the answer to that question. Thank you for your great questions. We're going to kind of move towards a close. So I'm very keen to allow our live audience, if there are any final questions? Yes. We have one there.

My name is Samuel. I work for Lagoda Investment Management. I guess 2 questions I had was, one, if you wanted to get approval for your NETs on your HIA or for Point of Care or for different applications? Will you need to go through another approval process for that? And second, like, have you started working with any partners who could sell your NETs test at scale in Europe? Or like how far away would it be to start talking to some of those partners?

I'll give the short answer to both and then maybe a follow-up. Yes, you would have to do more regulatory work and it would take a year or 2 beyond what we're doing for different platforms. We're in discussions with a few groups, but we can't talk about it now, but we haven't advance that far in NETosis side because it's actually been quite quick for us on everything else as well. I think NETosis is something which is unbelievably important, but it's something which is -- was any new to us in our process in the last year or 2. So it's probably a year behind where we are in the vet process. But we absolutely intend exactly like in the vet space to license to the big people, and probably know who they are. And we've got a team now who is doing that in Europe, and we'll update when it comes through. Anything else?

Just in terms of commercial discussions. So a lot of work that we've done on the vet side is on platform. This is obviously something that can be applied on the human side right away in terms of when it's ready on the animal, it gets applied. Some of the development work we're doing with partners that are interested in commercial potential down the line. So there is a faster path to be negotiating commercial agreements. It's already in the very early stage, but it's there.

And the vet from scratch until the Heska do was just over 2 years. So it can be done faster.

And on the human side, in terms of adding platforms, the basic technology stays the same. So you've got an advanced -- you're already through a lot of your development. It's optimization for new platforms. So it is a faster way to get that there.

But the platform we're going to use is fair to say are the major ones. We're not going to have to redo completely new trial for a new platform we discover.

Very quick-fire answer on this one because we're moving to a close, probably somebody watching from Sao Paulo or somewhere like that because they want to know are they going to get the Vets system in South America. Can we predict at this stage?

Yes. We will. But not tomorrow, but we're working on it, yes.

Okay. Oh, we have a -- great. We love getting live questions.

Antonio Verano, I'm a shareholder. So really interesting following the -- congratulations for everything has been achieved. At the moment, there's 2 topical questions. One is inflation that you touched on and the other one is supply chain. As you scale up, do you see any problems? Or are you planning making any provisions for anything to minimize that. The only reason I bring that up because I would imagine that probably even somebody like General Motors never expected a chip shortage.

I'll just give a quick answer and if you want to add anything else absolutely. So the pandemic luckily for us, it was serendipity and not good planning, but we bought a company which made one of the very key components, the recombinant nucleosomes. And they closed in January of 2020, so that was actually a very good timing. So the key components are all within our internal control now. We're also -- [indiscernible] is also here, has worked very hard on getting supply chains from the U.S. as well as from Europe so that we can meet orders very quickly and easily from the U.S. as a processing that going forward. So because we're in charge of the key components ourselves, and it's a very simple key components compared to a lot of other tests. We can manufacture them and contract manufacture, but we're very careful to have multiple suppliers in different areas to provide as locally as we can. So you never say never. You always said there could be some supply problems with what happens. But I think we've done everything we can to make sure we can really roll out quickly and do justice to our platform by quickly rolling it out. Thank you.

Great. Well, thank you very much, first of all, to our live audience, and now remote audience for some great questions, obviously, great engagement. And thank you very much for our panel. You certainly seem to know your stuff is brilliant. The last question, which come remotely, I can give the answer to. It's an easy one. Will there be a replay of the Capital Market Day? And will the slide decks be available? Yes. The deck is on the website right now, actually, so you can get that deck, and the replay will be available in the not-too-distant future. So if there's anything here, as I said, you want to share. So thank you to our panel. But most of all, thank you for taking time to come and join us. Whether you're live or whether you're remote, I'm just fascinated by this business. And if we're allowed to, we're going to stick with you. Thank you so much. See you all. Thank you.

Thank you.