Good afternoon to you all. A very, very warm welcome to Wall Street and a very historic building, the New York Stock Exchange. 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. We strongly invite you to submit your questions either live here in the audience, but also by investorrelations@volition.com. We have my colleague Louise here, Lou, who is going to transmit those questions to me. That's investorrelations@volition.com. We will be carrying the questions at the end of this session.
By means of a brief introduction, there are some familiar faces in the audience already that I think I may have met last year. My name is Nick Wood. I'm a former BBC television and radio journalist and a newspaperman, originally based in the UK, but I joined the BBC business unit, which sent me all around the world.
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. It is fantastic to be back. It's also been great in recent years for myself and my colleague to have followed the Volition 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.
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. Today, we have practitioners from the human health side and also the veterinary side who really, as we say in the U.K., 'cause 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.
They have a wealth of knowledge about how well or otherwise this is going to work in a very changing world. That really is one of the strengths of today's event. We need a good warm-up artist, so who better than Cameron Reynolds, who is, of course, Group CEO of Volition, to get us underway. Cameron, please join us on stage.
Thank you, everyone. It's great to be here and 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. I'll start off with our mission, which is very simple, to save and improve lives of millions of people and animals worldwide. It's been a journey now of 13 years, and I think we've developed a fantastic platform. 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. Volition, we do a lot of different things, and you're gonna 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.
Volition itself, we do all these things on our basic platform, Nu.Q, nucleosome quantification. The chromatin fragments which we measure, let us work in all the different areas. A lot of people say, "How can a company so small," we're just still over 100 people, "do so much and so many things and so much good in different areas?" I think the thing to remember in everything you hear today is all the same platform. 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 and Vets. Nu.Q Cancer, we're very still active in and would expect to have the first products in the next few years. 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, where they're using our platform for other things. Nu.Q Capture, we're developing a more advanced platform for detection of cancer as well. We'll focus today very much on what's very close to market, and it is either launched or about to launch in Nu.Q Vet and Nu.Q NETs. Of course, the focus is obvious. That's what we're doing right now and what people wanna hear about. We're very active in all our pillars. 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, are 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. Accessible. We're trying to do deals with lots of different people so that our platform, we consider agnostic, meaning we 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 plates, great way to start, a great platform. As you get to more and more tests and we want automation, we're now working on the second one. It's, it is a product now on the Nu.Q NETs 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 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. That's very important. Obviously, the Heska relationship is extremely important to us, and that's their machine.
The last two 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. 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. That would be truly something which can be done as part of ordinary blood work all day, every day in the big hospitals. Also very exciting, the last 1 is 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. That's very important. Gives you a number, not just a yes, no.
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. These platforms are important, but each one of these can be used in human, in animal, in monitoring, and in screening. This is how the platforms all work together. Oops, sorry, I went backwards. It's very important also to have good intellectual property. There's no point developing something fantastic and then having it other people has 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. That's another very important part of being successful.
All in all, I think, we've got a fantastic team now. You're gonna 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. I couldn't be happier where we are. Thank you very much for coming.
Thank you very much, Cameron, for getting us underway. It's kind of going to be a game of two 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. I think most people in this room would agree it doesn't get much sharper than an intensive care ward, particularly in recent years when we've had the COVID pandemic.
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 in the U.K., but I can tell you they are very famous hospitals. 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. What he doesn't know about sepsis really isn't worth knowing. Please, Andy, join us on stage. Tell us a bit more about yourself and a bit more about sepsis and also Volition.
Yikes. Wow. Thank you very much for that introduction. Thank you. I'm gonna skip forward, actually, just to say, these views that I'm expressing today are my own. They don't come from the trust that I work for, and that's just important for lots of reasons, for bureaucratic reasons in the NHS, but I think that's true. 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. Just picking up that last comment, there is an awful lot for us to learn about sepsis and improve outcomes. Seppo or the derivation of the word sepsis comes from a Greek verb meaning by rot.
In my day job, I see lots of patients with sepsis, and they die. If you go back to The Lancet, well, the most modern data is that a patient with septic shock and multiple organ failure, about 4 in 10 of those patients, 40% or more will die. 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 life-threatening organ dysfunction caused by a dysregulated host immune response to an infection. I'll come back to that at the end because I think it's a really important thing to bear in mind. Yeah.
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 of being a geek before, but that's probably true. The cross-link between infection and the hemostatic system is so crucial, and I think what I've been trying to explain is why I think the Nu.Q test, the Nu.Q H3.1 assay, is so critical to improving our understanding there and is potentially transformative. This slide was actually provided by Professor Dajania Nan, a world-renowned expert in sepsis, and one of the points we're trying to make here.
There are over 50 million deaths a year from sepsis. There are over 50 million cases, sorry, and over 11 million deaths a year from sepsis. 40% of deaths in children under five are from sepsis. Fifty percent of survivors are left with long-term sequelae. I chose that term "I rot" on the previous slide. You can see this poor lady. She's lost both her legs. She's had below-knee amputations. 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 postpartum mums, and then sepsis in older age. You'll all be familiar with COVID and the severe organ failure we saw with COVID too. Just look at this.
Yeah, per 100,000 people in the population, there are about 370+ cases a year. That's more than cancer, that's more than heart attacks, more than strokes. Whatever healthcare agency you look at, be that the World Health Organization, the National Institute for Health and Care Excellence in the UK, the CDC in America, and the European Healthcare Regulatory Authorities, sepsis is a key priority. Look at this slide that Dajali's produced. Look at the investment in sepsis. Huge burden of disease and less in investment there. We feel there's real potential to improve outcomes here. This is just taking us through the assay and what a NET is.
A NET stands for a neutrophil extracellular trap, and this is decondensed chromatin that's spewed out behind a neutrophil, and you can see the DNA being unspooled where it's wrapped around, these nucleosomes. The red Ys are our antibodies picking up those nucleosomes. It's just saying they're attached to magnetic beads here, and that's our proprietary, diagnostic assay. The link between, coagulation, hemostasis, and the immune system. I put this slide in here as a break.
I love Monty Python, John Cleese is just about to say to everybody, "What did the Romans ever do for us?" I think a direct link to me working with Volition, being involved in NETosis and studying NETosis is actually COVID, 'cause COVID revolutionized or really re-emphasized to us what we'd slightly forgotten about the link between infection, dysregulated response to infection, and thrombus formation. I'll skip past this. This is a complicated slide, and I'll try and take you through it. What are we saying here? Let's deal with bleeding first of all. If you're cut, you'll start bleeding. Your tissue factor is exposed, and your body stops you bleeding. You don't wanna bleed to death. We all know about hemophiliacs and the Russian royal family, et cetera, when they couldn't stop bleeding.
Doctors are really great at splitting things out 'cause that's an easy way to understand what's happening. That's not the real world. If you're cut, it's most likely you're cut on, I don't know, a piece of paper or someone stabbing you or falling over and grazing your hand while you're running, and your innate immune system is breached at that point. 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 my skin's been breached, our innate immune system's been breached, and we might be invaded by an organism. There's this cross-link and continuous talking between stopping bleeding and signaling your immune system. What we've got here and what we understand here is that NETs are a really key and important part of that bridge.
NETs spew out this DNA behind them. Sorry, I didn't mean to hit the microphone. The NETs are decorated with proteins that have a huge, 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 in them now as well, which is another marker that they've got to be important. NETs 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 excessive NET formation, those NETs can break away in your circulation and go somewhere distant. That circles back to this dysregulated host immune response.
You get excessive activation of your immune system, and if you have free circulating NETs, they can be directly toxic to other tissues. They can damage your heart, your lungs, your kidneys, your liver, your brain, any organ tissue you want. They're probably part of the key link of explaining why people progress to multiple organ failure. It's a potential real marker of severity of illness. The other thing is they're associated with blood clots. You can see the clot at the end there with platelets, these tiny little building blocks which are involved in stopping bleeding and red blood cells all bound together, and they can signal excessive blood clots. If you have small blood clots forming blood vessels, that can stop oxygen going downstream, so again, you get more organ failure.
There's really intimate link between stopping bleeding, hemostasis, and our immune system, and the basic building blocks of our immune system. Coming back to what Cameron said at the beginning, that's years of research I've just summarized in a very broad brush there. The reason I'm with Volition is that this is a diagnostic test which is easy to run. It's 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 gonna just go into teaching hospitals. It could go everywhere. You've already heard reference to the point of care testing down there. It's way away, 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 ITU. This is an early study, and you can tell we were stressed. This is wave one. We defined how sick patients were by where they were, so the sickest were in ITU, less sick on a normal ward or the floor, and then the emergency room here. Okay. The sickest patients were in ITU, and the sickest patients had the highest nuclear levels, died. We've seen that sort of finding repeatedly. This is another study produced by one of my colleagues, a lady called Katrien Reyskens, who works just down the road from me. Again, the thing to pick out here is the graphs. Again, we're seeing a consistent signal. Those patients with the most severe COVID had the highest levels. There was excessive immunothrombosis.
In the lower graph, you got a signal to the disease severity. The patients who died, their Nu.Q levels stayed persistently high and didn't fall. Those patients who improved, their Nu.Q levels fell. 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, be it with ventilators, be it replacement therapy, ECMO, special ventilatory support, cardiac support, et cetera. There are lots of organ failure scores, and they often come on huge checklists. In America, we tend to talk about the APACHE II score and the APACHE IV score. In Europe, we tend to use the Sequential Organ Failure Assessment score, the SOFA score. This paper, published by Morimar last year, shows that the Nu.Q level correlates well with Sequential Organ Failure Assessment.
Bluntly, the sick you are, the higher your Nu.Q level is. That potentially provides doctors with really useful and powerful information early. You heard Cameron talking about the tests and the turnaround time, potentially within 45-60 minutes, perhaps even faster. 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 score in itself is quite tricky and it's just a little cumbersome. It's slightly bureaucratic. There's lots of bits to check, et cetera, we just tend to use it in a research setting more than anything else. One of the things you'll come across and hear repeatedly in our talks is how early diagnosis is so important. I think we're all familiar with the concept that tissue is time.
Actually, if you delay giving antibiotics, patients will turn 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 huge room for us to potentially improve and change, and I think this test helps us in that process. One of the other things we've picked out as well is that one of the most common reasons for litigation to be taken against healthcare organizations, certainly in the U.S., U.K., and in Australia, is delayed or failed recognition of sepsis. Sending someone home 'cause you didn't think they were too sick or you just got it wrong. Hopefully this will be an aid, potential aid to diagnosis. Yeah, I think I've covered this all already.
It's about producing personalized care and showing that link between the innate immune system and infection. Just before I hand over to Remi, I'm gonna spend a moment on this slide. This isn't some intergalactic blob. This is a neutrophil ejecting that chromatin. There's nucleosomes behind it in NETs. It's labeled with this blue-green fluorescent dye, and that's attached to our antibody. This is showing that our antibody or the H3.1 antibody works. That's actually a NET that you can see there. To me, this is seeing the technology and visualizing it in action, knowing it works. It's really exciting times, and I'm very grateful for the opportunity. I'd like to hand over to Remi now, who's gonna take you through our commercial strategy. Thank you.
Hi, everyone. 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. Andy, very happy to team up with you. Congratulations for your nice introduction about what NETs are, our Nu.Q NETs assay and the underlying technology, and some information about the burden of sepsis and some insights on Nu.Q NETs and the potential to become a real game changer in the management of sepsis. The purpose of my presentation today will be to give you some insights on the key components supporting Volition strategy and roadmap in order to bring.
R&D biomarker into real-life practice. Before going more detail, a few words about me. I'm Remi, I'm French. I live in Grenoble in the Alps. I joined Volition in September 2021, so 18 months ago, I'm very excited and delighted to contribute to bringing this very innovative biomarker into practice, while at the same time contributing to improving patient care. Few words about my background. I hold a master in science and also MBA. I have 20 years of experience in the in vitro diagnostic industry and life science industry as well. I've been working for Roche 20 years, Dismax more than six years, meanwhile, I have been joining a startup company in Paris, which brought me some other experiences.
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. 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 NETs is exactly that, a disruptive technology which entails having a different approach to launch the product to the market as compared to more mature products. Right. Our focus with this Nu.Q NETs biomarker is to develop, as already been said, low cost, easy to use diagnostic test with 2 major aims and positioning. If we are reflecting back to the patient journey at presentation at the hospital, this test may help to risk stratify.
Later in the hospital stay, this test will also enable to monitor the disease progression as well as the response to the treatment. What have we been achieved so far? 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 two major clinical scores, so the SOFA score and the APACHE II. We've got the CE mark IVDD last year in May, which is a label of having brought to the market a very reliable, analytically validated, reproducible, and rapidly available test. Those are some features very important to convince potential users in the future that our test is very very important and powerful.
Basically in terms of strategy, we have four building blocks, I would say that would help us to transition from a more R&D type of company into a product-oriented organization. I will come in more details to those different aspects. If we want to become a test, if we 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. The first thing we have done last year was to become a member of the ISF. 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 against sepsis.
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. 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. U.S. is the largest market in healthcare 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 term of market clearance and products. What we have already started to undergo is Breakthrough Device Designation submission that we expect to be submitted this quarter. Few words on the commercial strategy. Again, if we consider Volition's major assets, I think it's our ability to develop novel biomarkers internally, but also with research partners. Build up a strong portfolio of IP, as Cameron mentioned, because this is the way to protect ourselves.
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. 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 Andy also explained the very strong interconnection between sepsis and immunothrombosis. 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.
For us, interest is low OpEx because we will delegate, I would say, and rely on the market expertise of established companies. In doing so, again, this will enable us to access the market on a worldwide basis. As I already said, we are under discussion with some major players. What sets us apart just will be the conclusion, by the way, and this was already mentioned by Cameron earlier. The idea here is to enable the test to be used for everyone, anywhere, anytime. If we now look at how the diagnostic market is set, we have very huge, big central labs with robotic chains. You just put the samples in and then get the result back.
It's also very important in certain instances to be close to the patient or near to the patient with point of care solution. 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. 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.
Very 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. Volition, as you know, are growing internationally. Just worth mentioning, Jasmine 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. There is this tremendous link between the USA 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 and us Brits who came over and tried to rule everything.
I was informed in no uncertain terms by the Belgians in the audience today that actually Douanesstraat, as it was known, was the center of a small Walloon community in this area. 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 two areas. 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.
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. 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. 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. Let's run that video now.
We started the Innovation Lab in 2021. We started at a local university in an incubator space. We were there for about six months. It allowed us to start some projects, get some staffing, and get some equipment. Last year, we moved over here to Carlsbad. The lab right now is about six people. The plan is to add a couple more throughout the year. Ultimately, the group will be 10 people. Innovation Lab, we have a very diverse team. We have people with expertise in genomics and bioinformatics, as well as proteins and proteomics. The goal of building this diverse team was so we're able to really answer whatever questions we were interested and let the biology drive us rather than our expertise.
We are the clinical development program. It was launched last year, and the sepsis product is actually the biggest piece of what we're focused on right now. We're trying to get a Breakthrough Device Designation through the FDA. We have a lot of clinical studies going on with DXOCRO. We've got a fairly aggressive timeline to get that product into the market.
We settle in this area mainly because there's about 250 biotechs in Carlsbad, and that gives us access to a lot of great talents. I soon realized that there's more than a pool of talents. There's actually an appropriate ecosystem for our activities. We're able to outsource manufacturing very close to this facility, allowing us to manufacture our products in the U.S. for the U.S. market.
We are a contract development and manufacturing organization, which means we develop different test formats from the ground up, or we simply manufacture test kits that other people have already made. The ELISA formats, rapid tests or lateral flow. We do microscopy, next-generation sequencing as well. We're FDA-registered, ISO 13485 for full design, so full human diagnostics we're certified to do. A manufacturing run for the Volition product, we make the ELISA microplates, so it's a three-day process there. We make all of the liquid components, so assay buffer, HRP, substrate, stop, wash, et cetera. We QC test all of that in-house. We fill them into bottles, we label the bottles, we do all of the correlation assignment testing to ensure lot-to-lot consistency, and then we assemble the final kit, store them here, and distribute to the customers as needed.
We're well-equipped to scale with Volition, whatever their needs are. We have a very good working partnership together. We're nowhere near our max capacity as it stands, and we're actively adding to that capacity.
Story, which takes us neatly over into the Volition Veterinary space now. I was saying earlier, I mean, if you wanted an illustration of just how crazy the companion animal market is going, you had to go no further than our hotel room this morning on Fox News and CNN, where we'd heard on top of the dog kidnappings 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 bulldog puppy could be stolen.
I mean, the market is going crazy around the world. I've just come back from Australia two months in Bondi. It is just full of dogs and also in the house, cats. The veterinary market is vast, and people are spending money to make sure their fur balls, as we continually hear, are kept healthy.
It is an enormous market. 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.
I wanna thank everybody for being here today. I must admit, I've always had a love for the way the BBC presents things. Nick, of course, has done a phenomenal job of doing that today. I am a veterinarian, Tom Butera, and I have two colleagues that are gonna be speaking to you today as well. Dr. Heather Wilson-Robles, who's a renowned veterinary oncologist, will be speaking to you per video. She's not able to be here today, but she'll be describing some information on new monitoring tests. Of course, we have the wonderful veterinary oncologist, AKA cancer specialist, Dr. Sue Ettinger, who is live here today with us, and we're delighted to have her with us on board. A little bit about myself, just to kinda 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 in academia to spending a number of years in clinical practice, corporate ownership, corporate development, and a significant amount of time in business development leadership at 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.
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're finding out about cancer interrelated and how that can benefit the human side and also vice versa. It's dynamic.
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, Volition. Having a veterinary component and an animal component 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 pets' lives as well.
To give you a little bit of idea about the opportunity on the commercial side, and I'll be speaking briefly today 'cause I don't wanna take too much thunder from the two esteemed veterinary oncologists that are with us today. The opportunity is immense for what we have in front of us. Our Nu.Q Vet Cancer Test is specifically a screening test designed to be used in wellness visits for people that have dogs that are seven 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 three-four years of age. One in four dogs dies of cancer every year. 50% of dogs over the age of nine, 10 years of age die of 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, or pretty close to every one of those dogs, is an opportunity for us to have an affordable, accessible cancer screening test run on their dog. We as veterinarians in our toolbox have not had something that's affordable and accessible. We have pretty much, unfortunately, put many. Sue can testify to this, we've shed too many tears, we've put too many dogs to sleep because they were sick. That 1- in- 4 that I gave you. Wouldn't it have been wonderful if we'd 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, you know, a lot of us are going for screening tests, memory tests, prostate tests. 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. Hopefully, in particular, I'll use the word lymphoma because that's lymphoma and hemangiosarcoma are two 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 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. 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 organs. They're not sick. 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, 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.
The a 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 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 beings. Dr.
Reddel knows very well a lot of the CAR T therapies and a lot of things that are being developed on the human side, and I'm sure that that will come over on the animal side as well. It's a major opportunity in front of us, and Volition, both on the veterinary 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 cats this year, and we're trying to identify feline lymphoma and cancers in cats. It's about a 50/50 mix. The other part of it is screening and then monitoring.
Dr. Heather Wilson-Robles is gonna talk to you about the monitoring paper that just came out yesterday. Two-thirds of that revenue stream will come from screening, and about a third 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 players in fragment and 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. 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 tests in front of every veterinarian possible so that they can utilize this test and hopefully save a lot of pets' lives. Underlying principles, we mentioned this before, Remi mentioned it, low CapEx for our partners and low OpEx for 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 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. We just launched with them in January of this year at the Orlando Veterinary Conference, and there were 26,000 veterinarians there. 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 UK and Canada, as well as venturing into Asia as well. We're gonna over time, gonna have some pretty significant distribution. 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, 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. That $13 million should be coming there, and then, of course, when we finalize our work on cats, 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 IDEXX, Volition makes money. Every test.
Ongoing revenue. 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%-15% market. We feel, especially with the usage of the point of care that's 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, one in Italy and one in Portugal, which I'll show you in a second.
You've all heard about the proposed acquisition of Mars, of Heska by Mars. Anticipating closing probably second half of 2023. Our Nu.Q Vet 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. 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 can see Portugal is there. You can see my hometown in Italia is there. Also there's down here near Australia, there's Singapore. The intent is worldwide distribution.
This is what we're looking for 2023 and beyond, especially when IDEXX launches, especially when Heska continues to roll out. 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. She'll talk to you about our exciting monitoring paper, which just came out yesterday and was published. This paper talks about disease progression using our test for disease progression and remission. I think you'll enjoy it. Following that, Dr. Sue Ettinger will speak. Thank you.
Thanks, Tom. 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 ELISA test that we have on the market now actually measures nucleosomes specifically separate from other forms of cell-free DNA using a simple ELISA platform.
The NuQ 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 a NuQ test for a variety of different cancers. One of our most recent peer-reviewed cases was what we call the multi-cancer paper, really it's looking at the seven most common cancers that are diagnosed in dogs and evaluating how well the NuQ 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 in a series of 528 dogs with cancer as well as 134 healthy dogs. We were able to find that the cancers we picked up most reliably included lymphoma, hemangiosarcoma, and histiocytic sarcoma.
Lymphoma and hemangiosarcoma 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 and hemangiosarcoma, in 2020 we published two papers that looked specifically at these diseases. We were able to pick up 77% of all lymphomas with a 97% specificity and 82% of hemangiosarcomas also with a 97% specificity. Basically three quarters or 76% of all of the systemic cancers that we tested, and again, half of all the cancers we researched. What I'm really excited to talk to you guys about today is a new indication for our NuQ 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.
Monitoring, now this is a tool that I can actually use every day in my clinic, very reliably. This new paper that was just published yesterday uses lymphoma as our sort of classic disease for monitoring. I'm gonna go through a little bit of the details about this paper, and kinda get you caught up to speed since you probably haven't had time to read it 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 spleen, in the liver, and it really pops up everywhere all at once. It's a systemic disease, it's typically treated with chemotherapy. The problem is it's not always easy to know when these dogs are in remission, and so we use a CHOP protocol.
This is a combination of four different drugs. There are four cycles of these drugs. We kinda give these drugs 4x over this protocol in these different cycles. As we treat them, again, up to 25 weeks, we're trying to figure out are they in remission? Are our 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 ultrasounds, we use blood work. Restaging a dog could cost as much as $1,500, and we're trying to do that maybe every two or three months in these guys on top of the chemotherapy expenses.
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. 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. 37 of those 40 dogs had lymphoma. We also looked at two dogs 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 nucleosome 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 thymidine kinase 1, but they really haven't been adopted by veterinary oncologists simply because they're not very reliable. So we aim to show in this paper that nucleosomes are better than those markers at monitoring lymphoma. Fortunately for us, we were right.
If we look at a little bit of the data, and I promise to not bore you with too much of it, but if you look at just a little bit of the data, what we can find is that 28 of the 37 dogs with lymphoma did have elevated nucleosome concentrations at diagnosis. That's about 75%, which falls right in with that 77% sensitivity that we've been talking about historically. Two of the dogs that did not have elevated values had something called indolent T-zone lymphomas. These are really sort of well-differentiated benign lymphomas that often don't have elevated nucleosome concentrations. Those guys can kind of be put to the side. The other hematopoietic malignancies, like the leukemias and multiple myeloma, also had elevated nucleosome concentrations, and those concentrations tracked just like the lymphomas in monitoring.
What this particular graph here shows is that we saw a significant difference when the nucleosome concentrations at diagnosis as well as at remission and at disease progression. These dogs were high at diagnosis, and when we treated them, their nucleosome concentrations dropped to the healthy range. In fact, all but two dogs had nucleosome concentrations that returned to the healthy range.
Those two dogs that did not had the shortest progression-free survivals, meaning the shortest remission times of any of the dogs that we saw. These guys came right back up when their disease progressed. When their tumors were coming out of remission, the nucleosomes showed that with a simple blood test that didn't require ultrasounds and 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?
We've kind of got three levels. These guys that were in the highest level did not do as well. Their remission times were shorter than those guys that were in the mediate medium or low zones. This can be very useful to pet owners and veterinarians to say, "You know, your dog is in this middle range. They may do better than the average dog with lymphoma." Or "Your dog's in the high range. This may mean that they're going to do worse." 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, Belle. Belle is an Australian shepherd. She's young. She's only three years old, unfortunately. 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. The green circles are when they're in a complete remission. This is based on our previous methods of how we monitor dogs, right? Me using my hands to see if the lymph nodes are small, blood work, things like that, but not any real molecular measurement of when their disease is progressing. 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 those last two chemotherapy treatments, you can see that her nucleosomes shoot up. CRP comes up a little, not a lot, and the Thymidine kinase 1 hardly changes. The nucleosome concentrations really come right back up close to 600, which is where it was when she was diagnosed. Based on everything we know from physical exam and blood work, she was in remission. We let her go. She finished her protocol, and then sadly, only three 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.
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 three weeks to get her back, and I definitely would have continued her chemotherapy. Here's a situation where if we hadn't gotten these numbers retrospectively, we probably would have treated Belle differently. Just kind of as a summary, monitoring applications. How would we use this? This is a way to track these nucleosome concentrations throughout 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 when 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 four times through that treatment, and at the very last treatment. I recommend that they test them every time they come in for a recheck. With lymphoma usually is every four-six weeks. With other diseases like hemangiosarcoma, it might be every two 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 gonna wait another two months to get them back in.
You're gonna get them in two 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's feeling better, before they're really starting to show symptoms of their disease. Now, Sue, take it away.
Hi there. Welcome. I have to say, I speak all over the country and world, this just feels different. Bear with me. I'm super excited to be here. I'm gonna give you my perspective as a medical oncologist with how I'm using this in practice. I have been consulting for Volition, I think a year and a half. I don't know. It's two years? It's like COVID years, right? Everything just sort of seems bun together. What I wanna do today is tell you some of the questions that I'm asked, how we're actually implementing this into our veterinary practices.
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?" Up till now, there really hasn't been. First thing is, what patients are we screening? As Tom mentioned, and I think Heather mentioned as well, all dogs over the age of seven. One of the things I'm always reminding veterinarians is that, you know, dogs age at different rates. Our Great Danes, our larger dogs are gonna age more quickly. We wanna think about that as well. 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 seven.
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. My Labradors have been tested with this as well. Penelope starting at around age just before five, and Matilda is 13. Luckily, so far, all the tests have been normal. For these dogs that are at high risk of developing cancer, I usually recommend, Tom mentioned about three- four. 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 two. You know, when I think about my patients that come in and I'm treating them for cancer, they often have other pets at home, right? They wanna know when should they start screening.
Again, age seven is good for most of our dogs, then if one of these high-risk breeds, usually around age three or four, if not a little bit younger. When do we screen? We wanna be doing this as part of their wellness exam. This is a test that you need to be running on healthy, fasted patients. Again, when they're coming in for their routine exam once or twice a year. I usually recommend twice a year for our pets, our middle-aged and older pets to be screened for cancer. You know, some people will say a year, but when I think about how dogs age, right, we say one year in a dog life is five to seven years, that's a long period of time to wait between visits.
I really think when they're coming in middle-aged and older, twice a year include the Nu.Q Vet Cancer Test. You know, as we mentioned, early detection, better outcomes, and that's really the goal with what we're doing. How do we find it? There's three 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, VMX, and I told the veterinarians that it was available at IDEXX, there was literally an audible like, they were so excited because that just means when you're pulling the rest of your blood work, you can check it off on, you know, online or on the, on the actual physical paper sheet, and you can get it back with your regular blood work. It's just easier for that. We're also available at 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 five. I've been treating Sophia for about two years for a high risk mast cell tumor. She's in remission. I said to mom, "She's a boxer. She's five.
We should include the Nu.Q." I submitted it on a Monday, got it back Tuesday evening. Mom follows me on Instagram. I DM'd her on Instagram that the test was normal. She was so relieved that she didn't have to wait and that, you know, we just had a clean bill of health for Miss Sophia. She's an adorable little boxer. What results do I receive? We get it back in three different categories.
The one that we want, you know, the one that Sophia is low risk. We call that the green zone. We have our high risk. This is a screening test. It's not a diagnostic. Once we get that back, we'll talk about the different ways that we're gonna work up that patient. Sometimes you get back, I call it the annoying gray zone, the one in the middle.
That is, maybe the patient wasn't fasted or you're going to have them come back, and we're gonna run through that as well. If it's a low-risk result, you're gonna have them you can repeat it at the next wellness exam, whether that's in six or 12 months. For that gray zone, the test requires a four-hour fast. Which I have to tell you, in veterinary medicine, not a big deal. An overnight fast, I have Labradors. Anybody have Labs? Any of the Golden Retrievers? It's mutiny if I don't feed them in the morning. The nice thing about a four-hour fast, if I know I'm gonna run a Nu.Q, is we'll do an afternoon appointment.
We can do an appointment at noon, one or two, and the Labradors, all those breeds that love their breakfast can still get it. If it comes back in the gray zone, we're gonna check with the pet parents that the pet was fasted. If they were fasted, then I usually recommend repeating the test in about two-four weeks. Most of the time, the motivated owners will wanna recheck it sooner rather than later. Then, as I mentioned, if it comes back in the high-risk category, then we're gonna proceed to the diagnostic pathway. The most important thing is getting that patient back in and repeating your physical exam. Now I'm thinking about some of the cancers that Heather and Tom mentioned. Lymphoma. Did I feel my lymph nodes well?
We're gonna go back, feel those lymph nodes, and just a good physical exam, feel the lymph nodes, you know, do everything, an oral exam, a rectal exam. We know that some of the oral melanomas can be picked up, anal sac adenocarcinoma as well. To be honest, most of the time, the laboratory tests have already been run. You are pulling blood for a wellness exam. If you haven't run it, I will advise the veterinarian to run basic blood work, urinalysis, and things like that. Then we're gonna proceed on to more advanced diagnostics, maybe an aspirate of a mass, something that we see on chest X-rays or ultrasound, and we may do an aspirate or 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 a 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. Cats are often a species that hide their symptoms, hide their when they're sick, and so we often find a lot of their diseases late. Again, this is gonna be really helpful to be able to screen our cats when they're younger.
I'm gonna share two case studies of mine that I've actually used this, so you can see how we're implementing it into practice. First one is Polly. She's 15 years old when I met her, and I think this was 2022. It was during one of the COVID flare-ups again. When I met her, she was two 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 we're over a year and a half out. They stopped 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.
Her primary care veterinarian had her come back to me to talk about how we could treat her bladder cancer. We do an exam. She has just things that I call pretty standard for middle-aged and older dogs, some tartar, 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. We're gonna do some chest X-rays and abdominal ultrasound. If everything looked good, we were gonna restart her on a new chemotherapy drug. Chest X-rays were clear, unfortunately, her ultrasound showed a splenic mass, a very large splenic mass, cavitated, so we're concerned that it's filled with blood. We're concerned that it's hemangiosarcoma, which is a very tough, aggressive cancer in our canine patients.
Now I was planning on starting her for chemo on her bladder cancer, I find this splenic mass. We're curbside, so the owners are in their car. I have to call them on the phone and say, "Not only do we see her mass in her bladder is back, unfortunately, we have this splenic mass." I tell them about the Nu.Q. I say, "We can run the Nu.Q. If it's normal, it's gonna lower my index of suspicion that this is a malignant hemangiosarcoma.
If it's abnormal, we're gonna be more concerned." 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 wanna take her straight to surgery. She's 15.
She has bladder cancer. Now they're like, "Okay, this is most likely benign." They decided to take her to surgery. This is her Nu.Q score. At this point, I was using Texas A&M. They were the only ones available at the time, her score is in the green zone. She went to surgery. She had a splenectomy, her spleen was removed. This is for any of the histopathology geeks out there. This is her normal benign spleen. It came back a splenic hematoma, likely arising from something called a myelolipoma. She then went on and I treated her for about another year for her bladder cancer. Really exciting. You know, again, it's not a crystal ball, but it gave 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 Polly. He was a very aggressive Ro-Rottweiler that came to me after he had been diagnosed with lymphoma. 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 nodes. His liver and spleen were normal. He was what we call sub-stage A. 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 his legs. We could get a blood sample from him awake. His dad brought him in with a muzzle. His dad was super sweet.
Otis actually kinda liked everyone on my team except for me. We always kept a muzzle on him. He was 140 pounds. This is not a dog that you wanna mess with. He does his chemo, he graduates about five months later, he's coming in for his monthly rechecks. He comes in in June of 2022, his lymph nodes were just a little bit big. Not ginormous, not really big, but enough that I was worried that his lymphoma had relapsed. In a normal dog, sorry, Otis, I would just aspirate his lymph nodes. Poke, you know, 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 him. He was just coming in for his healthy lymphoma recheck. I know you think that's an oxymoron, it's not. He was doing really well. He hadn't eaten since breakfast, so it was over the four-hour mark. It was about five hours. I could pull blood on this dog, I can't aspirate his lymph nodes. We talked about doing the Nu.Q to see if that was elevated, that would help me decide whether or not I should bring Otis back sooner rather than later to aspirate his lymph nodes. Unfortunately, as you can see, it did come back on the high risk.
I called Dad and said, "I am concerned that his mildly enlarged lymph nodes could be an early relapse." Dad was willing to restart chemotherapy if that was. He sedated him. He brought him back in two weeks later. I think it was about two weeks. Dad was traveling. We sedated him for those lymph node aspirates. Unfortunately, it did confirm relapse. That Nu.Q gave me that information that I knew that that was happening. We actually started him on a new drug, oral Laverdia. Dad was looking for something that didn't require quite as frequent visits and didn't require sedation. 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 kinda fitting here, right?
Otis is playing with a ball. He's wearing his muzzle and, you know. He's a good dog. He just didn't like coming in. Coming soon, you know, I'm so excited, I just have to say I'm an oncologist who sees the cases after they've typically been diagnosed, but one of my passions is early cancer detection. I'm so excited about this test. It's simple and it's affordable, and this is the baby that, l ook, bring this to me. I'm taking this home with me today. I live in the area. This is the point of care test. This is the one that's going to allow me-- I'm supposed to be getting mine in a couple of weeks. I've been talking, yeah, I know. I've been talking to them. This is from Heska. This is our point of care test.
This will allow me to pull blood, get that sample, so Sophia's mom doesn't have to wait 36 hours. When I'm using it for monitoring as well, I'll be able to get that right here. You know, you say bedside, we say cage side, but I'm so excited about this test. I think it's gonna be so, you know, great and not just for oncologists who are monitoring their cases as they're treating. I'm just gonna put this down here. No, kidding. Also for general practitioners, right? Owners don't wanna wait for results, and this will allow them to get those results in 10 minutes. If it's elevated, why, the pet's already there, you're not gonna require another trip for them to come back, and think about that pathway, you know, that we talked about to work these cases up.
This is a point of care test. This is from Heska. It's the Element i+. Like I said, I'm going to be getting this, or it's gonna be available. They were taking pre-orders in Orlando. I'm just excited about me. No, I'm excited about this and the opportunity for our patients. We'll get these results in under 10 minutes.
Like I said, just allow veterinarians while the pet owners are still there to talk about the results. I hate calling owners on the phone and breaking bad news, but now I can go in the room, sit down, and talk to them face-to-face. Again, it's gonna allow that workup and that intervention, early diagnosis, better outcome for our patients. 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.
Can we cue the video, please, operations room? There we go.
If you vet cancer tests, this is exactly what it is. It's simple, it's affordable, and super easy to use.
I think that the whole veterinary industry needs to move with the times, that we try to emulate human medicine as much as we can. The fact that we can screen and potentially detect cancer as early as possible means we're gonna get much better outcomes for our patients. Something as simple as a blood test, which we do every day, if we can then potentially prevent and treat loads of cases, that'd be brilliant.
We are definitely seeing an increase in it. We're seeing an increase in humans with cancer. There's so many more screening tests available. I have clients coming in, "Can't we test for this? Can't we test for that?" This is great news.
It's easy, it's a small blood draw. It's affordable. It gives pet owners access to this test. It really mirrors our message of IDEXX preventive care, where our whole aim is to find disease before they feel bad, before they have signs and symptoms, before any suffering's occurred. It really will run nicely alongside our existing preventive care programs.
I would probably offer it as a package with a wellness with those at-risk breeds 'cause that would be, you know, potential for keeping costs low and getting good client compliance.
Being able to run that test yearly would be fantastic, especially in our high-risk breeds. We see a puppy come in and, you know, we'd love to catch them early of the golden retrievers, the Labradors, the things that we see a lot of, cancer overrepresented. I think that gives owners a lot of peace of mind.
I have a lot of golden retriever patients, and I actually just lost a golden retriever patient to hemangiosarcoma hemoabdomen. I will probably add this to a lot of our at-risk breeds that we see that she talked about today as just an annual screening test since it is so accessible.
IDEXX, one of the commercial labs, is gonna pick it up, and we get twice-a-day pickups from them, so it'll be real convenient for us just to throw it in the bag and get it off to the IDEXX lab. For clients, I think it'll be a really good test.
Pet owners conceivably with this test will be able to come in for their annual wellness exam, and while they're getting screened for things like kidney function, heartworm, infectious diseases, it occurs to just about everybody with a pet at a certain age, "Does my dog or cat have cancer?" The ability to screen for that is unbelievably important. Once you've screened for cancer and you've identified it early, the monitoring of that pet while they undergo treatment and also post-treatment as recovered patients, I think is super important as well. The cost and the speed of this test, the ability to get those answers immediately and the ability to do them regularly at a cost that pet families can afford, we think is critical.
We see patients on a daily basis with cancer diagnosis, it's a massive part of our daily work. It'll be an absolute game changer to pick up these patients at a much earlier stage, allow us to instigate treatment earlier and we'll have a better long-term outcome. I think clients will jump at it really.
The point of care test is pretty cool. You know, the cancers that they are focusing on are ones that most of the time we're diagnosing when it's honestly too late or very late. Owners always, the first question they ask is, "Could we have caught this earlier?" The answer previously was no. You know, with this advancement, I think it's possible we do catch it early.
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 gonna move towards the final question and answer session before we go down onto the trading floor. 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 wanna 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 two 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. I'm gonna put somebody right on the spot because I think I've spotted in the audience Mr. Providenti, Anthony Providenti from the Heska Corporation. Where is he? Put your hand up. There he is. I'm gonna drop on him now. He doesn't know this is happening. 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.
Well, it was a great presentation, thank you for that. We're on the veterinary side only as Heska. Dr. Ettinger, I promised my own veterinarian a unit as well. Maybe we may have to arm wrestle for it later.
Strong
super excited, though, that the progress of the development is what we believe to be in the last phases of optimization. Everybody's super excited about that. 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. 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.
I kind of know what the answer is gonna be to this, which will probably be a blank, but I'm a journalist still. I'm gonna ask you about Mars. Can you tell us anything about Mars from your perspective?
I would love to tell a bunch about it, but I've been advised that that's not a topic we can speak to.
That sounds like lawyers speaking there. Well, thank you very much, Anthony. I dropped on you there, and thank you very much for kicking us off. In our shooting gallery, we're gonna be shooting first at Dr. Retter, 'cause we have a question just come through hot off the press.
Mm-hmm.
The inputs into the SOFA scores and APACHE II scores are tests and observations that seem routine, cheap, easy and fast, and likely done routinely in the ICU. While will a NETs test be better, do we have any data suggesting that a NETs test is more prognostic?
Yeah, we do have some data that it is more prognostic. The data is inputted automatically in lots of systems, but we always miss bits of it as well. The scores are more. Although they can apply to a patient, but certainly SOFA applies to a patient. APACHE is more a population score. They're more a research test to compare the sickness of patients in studies. What none of those organ failure scores do is tell you about activation of your innate immune system. The point I was really trying to get across is trying to identify this dysregulated host immune response. They don't do that. They tell you someone's potentially sick, but they don't give you the resolution that this test does.
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. 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.
You know, there's the data from the Lancet Commission, it's over 50 million people. Probably if you counted really rigorously, there'd be even more. 50 million+ cases a year, 11 million+ deaths, it's everywhere. It's every aspect of life, every population, every subpopulation, every race done. It's universal.
Obviously a big market. Do we have any questions from the audience at all?
Actually, can I pick up on that?
Please.
What'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 lab. It's doesn't require lots of complex technology to run it. I mean, you've seen this. That's not for humans yet, but it's the direction of travel, and that's where it's upscalable to. That's really transformative for delivery of healthcare.
Okay. Do we have any questions from the floor? We have more questions. Yes, this gentleman over here. We'll just bring the microphone over to you. Just whilst we're coming to you, I'm gonna stay on NETs. We're gonna come to you next, sir. Keeping with NETs, this question is for Remi. When do you expect to submit for Breakthrough Device status? If received, by when do you expect to launch the test in the U.S.? No pressure here, Remi.
As I said, submission is expected this quarter. 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 US.
Thank you.
Nick, just to add to that a second.
Oh, yeah.
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 NETosis brought on the animal side to our veterinary colleagues in 2024.
Potentially, Europe would be even before the U.S., so starting from next year or late this year as well. I think it's gonna be a very steady building program.
Yep
As the vet has a similar path to the vet.
Sir, you have the floor.
Hi. Yeah, thanks 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 know, elaborate more on the specific use case for the NETosis test and how it would fit into your day-to-day workflow and sort of like exactly where it's being used?
Yes. I'll come back to the APACHE score as well in a second. We've got this dysregulated immune response, and we know there's activation of coagulation, of normal clot formation and damage to your endothelium. We can't. Going back through the history of intensive care, there's been lots of trials with biologically active agents, things like something called activated protein C, thrombomodulin, other agents, but they've never worked. They've worked in small subpopulations, but they weren't able to work in larger studies. Probably the problem there is we can't tease out the sick enough patients or the subgroup of patients where it works. For me, what's really, really interesting is that this gives us a deeper understanding of the biology of our patients rapidly. It might manipulate what we do.
In terms of therapeutics for NETs, there's lots of potential therapeutic avenues to attenuate the effects of NETs potentially. Lots of potential drugs you could use, old drugs, new drugs. I say it wouldn't be particularly hard to develop an antibody, for example, against NETs. That's a large part of how the test works. I think there's huge treatment options there as well.
Is that enough of an answer to you, sir? Do you need any follow-up?
No, I think that's good. Thanks.
Great. 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? Tom, I don't know if you want to-
Yeah. That's a great question.
Good idea. You're certainly doing your bit.
Yeah.
Trying.
Just so you know how the, how 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're major KOLs and influencers to the GPs, and speak to our veterinary colleagues on the GP side, both in the US as well as in Europe, and veterinary staffs. 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 the last 18 months. Just now, we are beginning to pivot to the consumer. The last thing we want is our colleagues being surprised by a consumer asking for the test to be run, and they don't know anything about it.
Therein lies, we are now beginning to pivot to the consumer. Cancer Month is in November this year. Pet Cancer Month is in November. Stay tuned, there'll be a lot of information that's going out to the consumer by November of this year.
Sue, we've been at various vet shows in the U.K., particularly this year in VMX and Western. 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. As you said, now, whoa, you're getting rooms bigger than this full of people. I was there when that sigh went out when you mentioned IDEXX. Do you think that consumer awareness could force Mr. Providenti and his company to upscale it and also IDEXX as well? Do you think the consumer-driven demand is gonna be part of it?
I think it's part of it. I think Volition has done it correctly because you need to, as he said, make the oncologist aware of it, because they're gonna get questions from the general practitioner. The general practitioners need to be aware of it. The worst thing as a veterinarian is when an owner comes in and says, "Can we do this?" You're like, "I don't know what that is." Right? You don't wanna be scooped by it. I think we're doing it in the right way. I do social media. I do talk about this test. I get pet owners that are now saying, "I'm getting it run on a regular basis." You know, pet owners saying, "I can get this." Again, I think it's just part of the rollout.
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 Sophia who's, you know, in remission for a different cancer, they wanna be proactive, just overall awareness of it. I think the most important thing about this test is how simple it is to do. It's a simple blood draw, four-hour fast. Like I said, not a big deal, and that it's accessible. Again, you can, as we saw the veterinarian in the video, pull the blood, and you're just gonna throw it in the bag, right, when you submit the rest of your blood work. I think those are such pillars to this test being successful.
Cameron, you're keen to come in here.
There's, I'd say absolutely correct. You've got to put the cart before the horse. 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 but you cannot order it very easily. That's where the big partnerships came in to be so important to us as well. Obviously you want the vet to know what it is, the veterinary oncologist to know what it is. You also want them to be able to order it, otherwise, you're completely wasting the campaign if that's not available.
As of now, the vast majority of vets in the U.S. can now order the test through the companies we talked about. 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. We're leveraging the fantastic teams in those other companies. Also we're not forcing them to use our platform. They can put it onto, as Heska is. I think the big companies in the human space will also adapt it to that. 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. 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 and also grow very fast. If we had to have all those things ourselves, it would take a lot longer to get there. We're all about an open democratic product that can be used very variably very quickly. That's really important.
Okay, we're gonna wrap up in a minute because it's almost time to go down on the floor. I am 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 Cantor Fitzgerald. Question for you, Cameron, again, you're on the market there. Cost of the NETs test and impact on adoption. Obviously, there's a clinical need, but 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?
Yes. We're attempting to make all of our platforms in all the areas truly low cost, truly adapted to the needs. If you want it to be used hundreds and hundreds of millions of times, which I think per year, which I think it absolutely can be, you cannot be charging $500, $1,000 and needing your own sales force. We wanna keep it very, very low cost. And that means in the developing countries, it can be even cheaper than in, in developed countries. We are working now. We've gone through the process to get it on the market. As we have before, we show it works on one platform, like in the vet space, others adapt to their platform and launch.
Again, we wanna keep it very, low cost, easy to use, and very, easy to expand worldwide quickly.
Okay, 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. Don't all run at once, please. 50 people can go down on the trading floor.
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 chat among yourselves. Thank you to our panel. I think I've been fascinated. Thank you to our audience for taking the time to come and see us here. Finally, thank you to our webcast audience as well, and also to the technical teams here in the stock exchange. Thank you very much.
Thank you, everyone, for coming.