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spk06: Good morning, ladies and gentlemen. Thank you for standing by. Welcome to Village and Rx Limited's fourth quarter and full year 2020 earnings conference call. During today's presentation, all parties will be in listen-only mode. Following the presentation, the conference call will be open for questions. If you have a question, please press the star key followed by the number 1 on your touch-tone telephone. If you'd like to withdraw your question, please press the star key followed by the number 2. If you're using speaker equipment, please lift the handset before making your selections. This conference is being recorded today, March 23, 2021. I'd now like to turn the conference call over to Mr. Scott Powell.
spk01: Please go ahead, Scott. Thank you, and welcome, everyone, to today's earnings conference call for VolitionRx Limited. This call will cover Volition's financial and operating results for the fourth quarter and full year of 2020. along with a discussion of our recent activities and key upcoming milestones. Following our prepared remarks, we will open the conference call to a question and answer session. Also on our call today are Mr. Cameron Reynolds, President and Chief Executive Officer, Mr. Terry Cuse, our recently appointed Chief Financial Officer, and Dr. Jake McAuliffe, our Chief Scientific Officer. Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, These statements involve risks, uncertainties, and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance, or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the Securities and Exchange Commission. We do not undertake any obligation to update any forward-looking statements made during the course of this call. I'd now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?
spk02: Thank you everyone for joining Volition's conference call today. I especially appreciate it given the busy earnings call season. I'd like to start yet again by recognizing the amazing commitment and hard work shown by all of our team over the past year during these difficult times. I could not be prouder of their efforts. Despite the lockdown, we have managed to keep our main lab in Namur operational, and opened the new SilverOne production facility and indeed have made such varied and significant progress in so many areas of the business throughout 2020 and into the first quarter of 2021. Now that we have such a stable, reliable, reproducible platform technology that we think can and will be highly disruptive and influential worldwide in a wide range of areas. Before passing over to Tarek who will cover the financials and then moving on to our product launches, this being our annual call, I will start today by briefly discussing our 2020 highlights as a reminder of all the progress we have made in the last year. We bookended this year strongly, firstly by closing our acquisition of Optima in January, and then by launching our first product, the NUQ Vet Cancer Screening Test in December, and achieved lots of exciting milestones in between. As a reminder, the strategic acquisition of Optima helped secure the supply of one of the key components of our NUQ test, the recumbent nucleosomes, which we use as the calibrant. The transfer of know-how is now complete, and we now have the capability to manufacture a wide range of these key components in-house. 2020 was a pivotal year for NUQVet. It is truly remarkable to reflect that we only reported the proof of concept data in April of last year, and yet by the Veterinary Cancer Society Conference in October of 2020, we published all study results hosted a key opinion leader roundtable event, and by year end, launched a new QVET cancer screening test with Texas A&M. This is all a truly fantastic team effort, and refocusing on near-term product launch opportunities during the pandemic showed the amazing flexibility of our platform and team. This flexibility is a key aspect of our success. Throughout the year, we, as always, continue to strengthen our large intellectual property portfolio with additional patents being granted and new patent applications submitted, including in relation to the use of NUQ technology in mitosis, COVID-19, and other diseases. And we now hold 64 patents worldwide, with a further 90 patent pending. We also published and or presented at a number of conferences, most notably at ASCO 2020, with varied abstracts featuring performance data on our NUQ technology with respect to lung cancer and blood cancer, as well as performance data on NUQ capture. At our virtual market day in October, we announced our commitment to two blood cancer studies, both to be conducted in the US. The first of these studies is a large-scale, up to 1,500 subjects, regulatory study into the five most common types of non-Hodgkin's lymphoma. And the second is a proof-of-concept study for the monitoring of treatment response for the most aggressive NHL cancer, Both studies are now underway, with results from the treatment response study expected later in the first half of this year, and likely the first readout from the NHL Regulatory 4510 case study within the next year. So we have had an action-packed 2020 and have a lot to review from the start of 2021. But before I go into more details, please allow me to introduce our new Chief Financial Officer, Terry Cuse. that will take you through the key financial results for 2020 and provide an update on the recent financing transactions that have significantly strengthened our cash position. Tarek, great to have you on board. Over to you.
spk03: Thanks very much, Cameron, and thank you, everyone, for joining our earnings call today. I look forward to meeting many of you in person when possible. I will now provide a summary of the key financial results. For the year ended December 31, 2020, we reported a net loss of $20.4 million as compared to a net loss of $16.1 million in the prior year. This result was predominantly driven by higher research and development spending, which increased by $4.2 million over the prior year period to $14.5 million in 2020. reflecting the investments we made in expanding our employee team and securing the supply and manufacture of key components through the Optima acquisition, as well as higher research spending directed at COVID-19 and mitosis. Despite this higher level of spending, we closed out 2020 with cash and cash equivalents of $19.4 million, compared with approximately $17 million at the end of 2019. And to add to this, during the first quarter of 2021 to date, we have significantly strengthened our balance sheet by adding an aggregate of approximately $20.5 million in cash through an underwritten public offering of our common stock in February, as well as through our at-the-market equity distribution program. Furthermore, in January, we were delighted to announce the award of approximately $4 million in non-diluted funding from the Walloon region and AmorInvest. We have a long history of support from the agencies of the Walloon region, who to date have awarded Volition approximately 13 million in non-diluted funding, including this most recent award. We would like to publicly thank Monsieur Willy Borsas, Vice President of the Walloon Government, the Walloon Minister for Economy, as well as Nicolas Delahaye and Renaud Hatiez from Namur Invest for the financial assistance and their continued support. So, just to recap, Before taking into account the expenses we have incurred thus far in 2021, our cash and cash equivalents total approximately $40 million, which is by far the strongest cash position we have ever had in the company's history. Nevertheless, we continue to manage our expenditures carefully. Our burn rate through the final quarter of 2020 was on average approximately $1.5 million per month. Overall, we would expect this to increase slightly as we make additional investments towards our product launches and expansion of our platform, and I will provide periodic updates on our future earning calls. In summary, we're in a strong financial position, providing us both a great runway to achieve our many milestones and continuing flexibility to weather the pandemic. And with that, I will pass back to Cameron for further operational and product updates.
spk02: Thanks, Derek. and I'm absolutely delighted to have the strongest balance sheet we've ever had, and great to have you on board. In fact, whilst talking with new team members, I'd also like to publicly welcome Gail Fortere, our new Chief Commercial Officer, to our Executive Management team, as well as congratulate Gitan Michel for his promotion to Chief Operating Officer, and Dr. Mark Eccleston, one of our founding scientists, for his promotion to the newly created role of Chief Technology Officer. As we are transitioning from a research and development company to a commercial company, we're excited to strengthen the leadership team with these key appointments. All four bring strong global expertise and experience to their respective roles, and these appointments aim to provide a very strong product focus to our management team. Also, from an expansion point of view, we're absolutely thrilled to have opened SilverOne, the production hub for our products and components close to our lab in Belgium. I'm very happy to announce today that we are now producing several of our key components and plan to achieve a full ISO certification later this year. As with our previous real estate transactions, the vast majority of the purchase and fit-out costs were supported through non-dilutive grants and loans from the Namua region, again helping to keep our burn rate relatively low. We are well into the process of producing at large scale raw materials such as recombinant nucleosomes, which act as a calibrant in our UQ assays, in addition to antibodies that are key elements to our branded products. And indeed, we'll manufacture our full diagnostic kits once finalised. We expect to offer all elements for both commercial sale and for clinical trial purposes, and CMRK products for sale in Europe and beyond. We're also installing a service lab in the new Silver One facility. which will undertake sample processing for external parties, including sample processing for new cuvette in Europe, more of which I'll discuss later. The opening of our new Silver One facility not only brings the manufacture of key components in-house, thereby securing our supply chain, but it also should significantly reduce the cost of production of any of these elements and should in turn reduce the cost of future assay development. It really is an exciting time and I could not be happier that we could find a suitable site so closely situated to our current lab Plus, it's another great step forward on a road to a diverse revenue stream. Speaking of revenue, I was delighted to have appointed our first sales manager in Europe, Emmanuel Demilcom, who started with us in December. Emmanuel brings over 25 years of sales experience in the diagnostic field, having worked for companies such as Roche, Sanofi, and most recently Vela. He has already proven to be an excellent addition to our team, with his folks to help drive revenue from our Silver One facility. Emmanuel has been hard at work at generating initial revenues for our products in Europe, and we will update you with the results of his excellent work in our next quarterly earnings call in May. And finally, with regards to organisational expansion, we opened a small, shared laboratory in California State University, San Marcos, in the fourth quarter. This lab is led by Dr. Terry Kelly, Chief Scientific Officer of Illusion America, Inc., It focuses on blue sky innovation and discovery research, which we hope will help us leapfrog forward on some of our cutting-edge research projects. And so, to our first products and revenue. Many of you have followed and supported Volition for many, many years and know that it has been a long and winding road, and so the whole team was especially delighted to launch our first commercial product, the NUQ Vet Cancer Screening Test, shortly after our 10-year company anniversary in the fourth quarter of last year. This was an extremely important milestone for the company, as this first launch, that we expect to be the first of many, demonstrates that our platform has reached a level of reliability and reproducibility to be launched in a completely independent laboratory. The test is positioned for use in both the annual health check for older dogs, those that are seven years and older, and for cases where there is a high suspicion of cancer. It may also be a complementary test for younger dogs of breeds at high risk for developing cancer in their lifetimes, such as golden retrievers. The test is currently available only from the GR Lab at Texas A&M University with the beta launch focusing on veterinarians across Texas. So what is a beta launch exactly? The beta launch is to facilitate real-world learning from actual customers paying for the test to help shape the marketing mix before we launch nationally across the US as expected in the next few months. It also gives us a chance to showcase the product to the large multinational vet companies we are in very active discussions with, which, if concluded successfully, would help greatly accelerate launches and sales worldwide. Given this is our very first commercial launch, we are using Texas as the test market to make sure all aspects of our products are properly tested before we launch in the US nationally and worldwide, and to help us address beforehand any issues with companies who may end up tributing or licensing our VET products. We are gaining extremely valuable feedback on key factors, such as the logistics of a veterinarian taking a sample, shipping, processing, reporting, and interpretation of the results, levels of customer service required, pet owner feedback, and of course, the optimal pricing at all levels. The team has also done a fantastic job in starting to educate the KOLs, the key opinion leaders, the oncology specialists, and GP veterinarians in Texas about nucleosomics and raising the general awareness of the NUQ Vet Cancer Screening Test. In terms of the commercial opportunity and the addressable market, cancer in dogs is widespread. It is a leading cause of death in dogs over the age of 10, and there are over 6 million new dog cancer diagnoses in the US alone each year. As cancer screening is not as commonplace in the animal health as it is in human health, we believe blood tests like the NUQ Vet Cancer Screening Test could help transform how veterinarians manage cancer in companion animals. Early diagnosis of cancer has the potential to help improve the treatment and quality of life, as well as providing valuable additional information to inform the clinical decision-making process. Our new QVET cancer screening test is a simple, low-cost, easy-to-use ELISA-based blood test, which we believe will help streamline the screening process for up to one-third of pregnancies in dogs, including common pregnancies such as lymphoma and hemangiosarcoma. We recognise the desire to receive revenue guidance now that we have had our first commercial product and aim to provide this later in the year when the mix of our own launches and licensing of our technologies to third parties in both the veterinary and human spaces become clearer. Suffice it to say, we are very happy with how the beta launch is going. It is providing us with absolutely invaluable information and our very first ever product revenue. We received the first order for our kits from the GR Lab late last year, and since then, they have reordered kits twice already this year. In addition to the Texas beta launch, to leverage our global team, I'm delighted to say that we are finalizing beta launch planning in both Asia and Europe for our vet cancer screening test and expect a lot of news on these in the next few months. We're also continuing significant licensing discussions with the well-known major players in the vet space around the world. I look forward to updating you on our progress in the coming months. We're at the very beginning, but we believe that is a fantastic opportunity, and we are truly excited to start commercial operations. Moving on from the vet business to human cancers, where, in parallel, we're also continuing to make progress. In January, at the world's largest dedicated lung cancer conference, the WCLC, an abstract was presented by one of the members of the National Taiwan University team, The key message from this presentation is that based on an interim analysis of a subset of subjects in our ongoing study, UQ assays could help identify noncancerous nodules following the scan, thereby reducing unnecessary biopsies by as much as 32%. These results of this subset of the 1,200-subject study are very promising. As you will know, low-dose computed tomography, LDCT, is the widely accepted standard for screening of individuals at high risk of lung cancer. However, LDCT has several limitations, including poor specificity, which means high false positives. Results from this study suggest that nucleosomes and histone PTMs may discriminate well between non-cancerous benign nodules versus very early stage lung cancers, stage 0, stage 1, stage 2, in non-familial lung cancer history patients. The ability to distinguish between cancerous and non-cancerous nodules could reduce both unnecessary biopsies and the frequency of radiation exposure from repeated LDCT scanning. Professor Chen, the study's principal investigator, said at the time of the conference, to accomplish this result through a non-invasive blood test would be an important step forward in lung cancer screening. Lung cancer remains the deadliest of all the cancers, and there is a high unmet clinical need for improved diagnosis. We are hopeful that our new Q assays can help and are delighted that our world-renowned collaborators presented this data at such a prestigious conference. We share our collaborators' excitement to complete this study and report the findings at scientific conferences later this year. And if it continues to go well, launch a 510K regulatory study in the US, like we have in the blood cancers. We've also made great progress on the research program for the use of our new Q technology in mitosis. and in particular in monitoring disease progression of COVID-19 and sepsis, and, as announced earlier this week, as a potential companion diagnostic for treatment of sepsis, and are looking to broaden this further into influenza and potentially other diseases associated with mitosis. To add a bit more colour to this discussion, as this is a new and very exciting use of our NUQ platform, and to provide some of the science behind it, I'd like to introduce Dr. Jake McAllister, our Chief Scientific Officer.
spk04: Thanks, Cameron, and good morning, everyone. It's great to be here. While cancer remains our core disease focus, given the relatively recent understanding of the prominent role of both NETs and nucleosomes in the pathology of COVID-19, sepsis, and many other diseases, we are also researching the use of our proprietary technology in diseases with particular regard to NETs and the doses. In terms of background science, White blood cells help protect the body against infection by engulfing invading viruses and bacteria and producing antibodies against them. In addition, white cells also eject chromatin material out of the cell to form neutrophil extracellular traps or nets, which catch and trap invading viruses. In a respiratory infection like COVID-19, white cells migrate to the lungs where they produce nets to trap and kill the virus. This protects the lungs and prevents the virus from spreading to the rest of the body. Nets are therefore a crucial part of the immune system. However, overproduction of nets is pathological and elevated levels of nets are a clinical complication of COVID-19 leading to poor patient outcomes and can actually be fatal. Nets are similarly a complicating factor in a wide variety of other diseases, including respiratory infections, SARS and pneumonia, as well as metabolic diseases, autoimmune conditions, inflammatory conditions, cancer, thrombosis, stroke, and sepsis. The ejected NETS material is made up of nucleosomes, and Volition has spent 10 years developing antibodies and assays for nucleosomes, so we are well-placed to take a leading role in much of this research. we can detect nets in minute quantities using Volition's NUQ nucleosome assays. Indeed, I believe our assays are the only analytically validated quantitative nucleosome assays currently available. We're investigating the use of the NUQ platform to monitor natosis disease progression and treatment response across a wide range of diseases that involve the overproduction of nets. Last year, we showed that nucleosome levels strongly correlated with disease severity in the first wave of COVID-19 patients. Patients admitted to hospitals had higher levels than patients with mild disease. Patients requiring intensive medical support in intensive care units had higher levels of nucleosomes than patients admitted to regular hospital wards. And patients who died had even higher levels of nucleosomes than patients in intensive care who survived. We have now conducted studies of serial testing in individual COVID-19 patients admitted during the second wave to determine how predictive our test is. This has taken longer than we expected. As the hospitals we are working with have, understandably, been focused on caring for the very high numbers of patients admitted during the second wave of the virus. We will announce data from human COVID-19 and sepsis studies over the coming quarters. In addition, we are releasing data from an animal study of sepsis this week in a presentation by Dr. Andrew Aswani, a consultant in critical care and anesthesia at one of London's leading teaching hospitals. This small initial study looks at the use of Volition's NUQ net assay to monitor treatment response to a novel therapy to remove nets from circulation in a peak model of sepsis. resulting in improved physiological and biochemical well-being indicators of the pigs. The results showed that the treatment was successful and that our new Q assay was the best and most practical way to measure Lynette's response. The studies are now progressing to investigate further animal models, and the first human trial is already being recruited. Following this success, we are investigating two further therapeutic antibody mitosis drugs, both in relation to treatment monitoring and for use as a companion diagnostic for patient selection. While mitosis is still a relatively new field for volition, given positive early results, this is shaping up to be potentially a significant new opportunity to utilize our new Q platform. We have formed a new QNet team to provide increased focus and drive to the product development program. This once again underlines the strong breadth of the new Q platform technology, which is supported by our broad intellectual property portfolio. Exciting times for sure, with further data due to be presented at upcoming conferences. And with that, I'll hand back to Cameron.
spk02: Thanks a lot, Jake. Exciting times indeed. And so to the future. I would like to reiterate our vision and what makes us so excited with the progress and our space. Volition is an epigenetics company focusing on advancing the science of epigenetics and exploiting these advances in human and animal health. This has been our mission since our founding, and it is coming to fruition with our NuQ platform at the very heart of epigenetics. We believe the last decade of work at Volition with our ever-expanding team in epigenetics puts us in an extremely strong position with our expansive IP portfolio to be a significant player in this key field. Overall, on so many fronts, with our ever-growing team and IP, I am delighted with the progress we are making, and I'm excited by the momentum we have developed in the epigenetics field. Indeed, our whole team is incredibly excited by the company's future opportunities. We aim to report throughout 2021 and beyond numerous key milestones, now that we're in full swing in turning our platform into a range of products worldwide. We will focus on driving revenue in the coming quarters where possible during the pandemic in four key areas. One, vet products. Two, disease monitoring tests, such as in COVID and sepsis. Three, using our new production facility to drive reagent sales. And four, licensing of our technology for others to commercialize worldwide in both the human and vet space. We also aim to publish data on multiple fronts including MuQ Capture, which I have not discussed at length today, but is also making very strong progress. I, along with the rest of the board, and indeed the whole company, look forward to sharing the results of key studies over the coming months and year with our optimized platform. Despite the pandemic, 2020 proved to be our most exciting year yet, thanks to our fantastic, hardworking team. But we're hopeful 2021 can top it. Thanks again for joining the call today. I very much appreciate it, given the busy earnings call season. We're happy to take questions. Operator?
spk06: Thank you. At this time, we'll be conducting the question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. And our first question is from the line of Kyle Mixon with Cantor Fitzgerald. Please proceed with your question.
spk08: Hey, guys. Thanks for taking the questions, and congrats on all the progress this year at Trade to State. Just regarding the necrosis trial that you're still negotiating, I just had a few questions around that. So first, is the intention to conduct a trial that kind of looks at all or maybe or some of those diseases like COVID, influenza, sepsis, or will just one be examined in the trial? And then second, is it possible that the trial could assess treatment monitoring with mitosis-based therapeutic antibody drugs? I know Jake mentioned this, and there's a few that you guys are looking at. I was wondering if that's an application in the trial. And then finally, when you say like a large trial, I noticed that in the press release. Does that maybe mean like the size of the blood cancer study in the U.S.? Thanks.
spk02: Hi, and thanks for your support, and just some very good questions. I'll answer those briefly myself and then see if Jake has anything to add. So, yeah, of course, so the first question really, I guess, pertains to whether we do a separate natosis trial for COVID for influenza and sepsis. We have been in discussions on one for influenza and COVID, but I think given where we are, we're probably more focused now on having one for sepsis because it's a very, very – I think, as you know, it's what kills most people in hospitals. Obviously, it would be applicable if it works in sepsis. It will almost certainly work in the others. But influenza and COVID, the numbers obviously go up and down, and they're sort of overwhelmed hospitals at the moment. So we are, in the US, we're looking to do a large trial, which is the third question. It's probably, it'd be about the same cost we'd expect as the other 510Ks, but when you're doing longitudinal samples, which this would probably be, you have probably a similar number of samples, but less patients, if that makes sense, because you're looking to get four or five samples from each patient. So it would be a very similar scale of trial. The exact numbers you need for a longitudinal study, we're still working on. But I think we'll end up with a product for mitosis, which will work in sepsis, we expect and hope. We'll see how it goes. But all the things we're seeing now are extremely encouraging. And that would be useful for all three. So we're just debating at the moment whether the first cab off the rank, if you will, would go for influenza and COVID, or whether we would look to do one in sepsis. But sepsis is probably the big market that's obviously going to continue for a long, long time given it's such an endemic issue. And as far as the drugs, so we're looking at several therapies. I believe Jay can confirm this, but the trial for the drugs would be a separate one because obviously it's not diagnostic or prognostic or disease progression. This would actually be as a companion diagnostic. So as you saw, we had fantastic data with Santersis. Our assays worked spectacularly well and by far the best. And of course, our assays are always routine, low cost, easy to use. So I think we'd have tremendous advantages over any options. But the trials would be different from the other ones for sepsis and COVID because that would be the diagnostic ones. But I think we would look to certainly the proof of concept studies on the You are correct. There's the Santersis method of therapies and we're also looking at some potential drugs and proteins that can also be useful. So we could probably package those together in a proof of concept study where we're testing several of those at the same time. But I'd imagine the actual therapy trial would have to be something separate because it's a companion diagnostic to the therapy. But I think Jake can confirm all of this, but it's incredibly exciting to be at the heart of all of this as well as cancer and the vet space. Jake, did I get that right? Anything you'd like to add?
spk04: No, I think you've got pretty much all of it there. The sort of background is that the way that the nets behave is similar in all of these diseases. So you could, in principle, have a diagnostic for NETs. In the beginning, we are looking at separate diseases. All of that is going very well. And probably, as Cameron said, at the beginning, it will be sepsis or COVID. And later on, we might be able to look actually at mitosis as an indication in itself.
spk02: And I think it's important to just reiterate, it has taken some time. We were hoping for some data late last year, but as we've said a few times, it's very understandable that some of the longitudinal studies have been tough when an emergency ward is overwhelmed. Taking 10 samples from one patient is not their top priority, quite naturally and quite rightly. But I couldn't express strongly enough. too strongly how happy we are with the results and how our collaborators are really appreciating not just how well the data is coming out but also how well our assays perform. All the work we've done now means we can ship kits to a range of places where they can be run and they're just working tremendously well both in doing what they should be doing and also just being robust and reproducible and reliable. So I think we've put ourselves in a really good position and we'll have a lot more updates on this throughout the next month or two and through the quarters but I think this is going to be a big part and one of our four key pillars of the company going forward because, yeah, NETS is only recently understood, but I think we can be really at the heart of the treatment as well as the diagnostic, prognostic, and disease progression for NETOSIS as well.
spk08: Okay, that was great. Thanks so much, Cameron and Jake. That was an excellent, really comprehensive answer there. And I just wanted to switch to the vet cancer screening product. On the beta launch in Asia and Europe, It's really encouraging to hear you guys kind of want to target those markets. It's obviously pretty large. I know it's still pretty early on, obviously. What's the general plan with, like, with marketing distribution? And do you already have relationships with some vets, I guess, in Asia and Europe, maybe similar to what you have in the U.S. with Texas A&M? And then, you know, again, another difficult question to kind of answer at this time, but when can the launch maybe occur? Is that more –
spk02: a 2022 event or could that possibly happen in the back end of this year thank you uh very good question so yeah we've actually obviously got a strong footprint in europe and in asia um we're very hopeful it'll be this year and actually uh it could be reasonably soon because we're we're doing a lot of work on this uh we'd like to do beta the same lessons we're learning in the us we can use a lot of them obviously in different markets but every market is a bit different We're in quite advanced discussions in Asia and we're starting in Singapore because that's where we are. And you can learn a lot of lessons in a place like this, like Singapore, and then use that for other markets. So I'd expect that in the short to medium term. In Europe, we're actually very active as well and looking perhaps for a slightly different model. We've been shipping kits to Texas GI Labs But we actually have our own lab in Belgium now, Silver One, the famous Silver One. So one option we're exploring very seriously is actually that becoming the equivalent of the lab like the GI lab in Texas. So then we could be running the samples as well. And that's for that way we can also, because it's right in the heart of Europe, it's an easy place to ship to. Obviously Belgium is very well located and we are the best at running the tests ourselves. So I think that the three main ways of generating revenue from the vet space we're actively looking at for this year, that's the kit sales like we are with Texas currently, then running it as a service. I think there's a very strong chance we'll have that running in kind of the medium term of this year in Belgium. And we're looking in Singapore as well, having a lab where we run the tests either contracted out or one we set up ourselves. And also, I think we really should emphasize what the beta launch has also given us, apart from all the learnings, is very much the attention of the big companies as well. You're taken much more seriously when you run the product yourself. You show it works. We're not testing the product. The product has worked absolutely perfectly. We're testing the marketing, the logistics, and all those lessons are very helpful for the bigger companies as well. I won't mention the names on the call, but they're only two big companies and we're in very active discussions with both for different reasons. And that could really turbocharge the revenue if we end up doing something we could accept with them. They each have hundreds and hundreds of salespeople throughout the US and worldwide. So I think it's very fair to say I'd be upset if we didn't. You say, is it possible for this year? I'd be very upset if they both weren't launched this year and perhaps sort of more sooner rather than later for at least one of them. And there will be a mix of all three. What our platform really allows us to do is all three. We can sell kits, we can do it as a service, and we can license just direct up, but still selling our key components. And I'd expect all three to have a strong component worldwide. So, yeah, this has been happening below the surface. Obviously, we can't say anything beyond that until it actually happens, but I'd expect to see a lot of progress on all these fronts this year. And the beta testing has been, the beta launch and all the testing we've been doing has been completely invaluable. We still think, what we've said before, it's a market that could absolutely change the way volition is seen and then generate a lot of revenue. So we're taking it very seriously, and you'll see a lot more news on that in the coming months and quarters. Did that answer your question?
spk08: Perfect. Yeah, that was great. Thanks a lot for that, Cameron. Just one last question for me. Similar line of thought, maybe on the expansion in the U.S. with the vet test. So I guess how are you evaluating some of the markets that you want to expand into? Like you're evaluating marketing mix, I guess, right? So, you know, what have you seen so far with respect to how different marketing channels are, you know, how they're responding or what the feedback has been to your efforts thus far? And, you know, And, yeah, just how are you thinking about the expansion in the U.S. really? And what, I don't know, what can we expect maybe over the next few months or so? Just broad, you know, high-level kind of comments would be awesome. Thank you.
spk02: Yeah, absolutely. So we're looking now, obviously, all those key lessons pertain to we wanted to get right before we launched nationally. They sound boring and things, but the logistics are very important. Whether at DOG we've had feedback that less fasting is better, so we're doing tests now to see, If we can bring that down from eight hours to four hours, then it doesn't have to be overnight. Whether you can ship, we're testing also just overnight on ice rather than freezing, all these kind of things are big for us. What our marketing mix looks like actually would, I think, depend on whether we do end up doing a deal with either or both of the major players, because if part of doing a deal with one of the major players, particularly in the US, is they would really lean into the public awareness and the marketing. Obviously, anything like that would be a much bigger market. We'd get a slightly smaller share of it, of course, but you would do that because it would greatly... The only way we do it is if they're really leaning into the sales and marketing as well. So we're working through all of that ourselves, and obviously, if we do not do a deal with a major player in the US, then we'll do a lot more marketing and facilities and the process. If we do, we'll end up doing less and that will become obvious in that mix as we finish off the Visa launch and then work out what licensing and or marketing we're going to be doing with the larger companies. So I'd expect to have that sorted out in the next quarter or two, and then that mix is how we'll go forward.
spk08: Okay. That's really helpful. Thanks a lot. So I'll leave it there. But, again, guys, congrats on all this progress. Looking forward to the updates coming up. Thanks. Thank you.
spk06: The next question is from the line of Jason McCarthy with Maxim Group. Please proceed with your question.
spk09: Sorry about that. I was on mute. This is Michael on the line. Thanks for taking the question. I'd like to gauge just on the size of those Texas ANM orders, because you mentioned that there were three additional in 2021. Were those based on the demand they're seeing, or were they more expected as A&M scales up their supply for the launch?
spk02: Oh, it's completely based on demand. So you see from the accounts, it was just a little over $7,000, which equates to four kits, which if they used every plate, which they don't because they have to do some repeats and things, but that's about 160. We're making the revenue from 160, if that makes sense. And actually, you probably noticed in the script it was two, and then I said three because they just reordered a few days ago, and there was some time between the recording. So when they run out, they order more, basically. So that's going. I mean, this is about the revenue, of course, but it's about the learning from the beta launch as well. But it's very nice to have all these things being sorted out. We thought the best way to really learn all these things is to actually have real paying customers. There's dozens of vets who've ordered it. Texas A&M have given us great feedback just on the actual running of the test themselves. And as I said, the actual test is working absolutely perfectly. This is all the marketing and the packaging and all those kind of things. But yeah, so they ordered 7,000, which is enough for 160 dogs. And they've reordered, it was two times last week, and now it's three times. And they just keep reordering a batch once they, I guess you call it just-in-time ordering, as they finish the previous one. So that's exactly in line with where we thought they'd be. We haven't obviously done a lot of marketing. We've done bits and pieces with the key opinion leaders throughout Texas, but obviously nothing nationally. So this is the level we're expecting, and it's been absolutely great from the feedback point of view. And I think it's really helped us sharpen our pencil for the international and national launch. And also... Again, I think it's really focused the mind on the big companies that, you know, with the trains moving, if they want to get aboard, they've got to get aboard. I think if we'd not launched, I think there would be a lot, it wasn't the same level of interest before we launched as there is now. Because at the moment, we are the monopoly in the space. There is absolutely nothing else out there in the cancer space in the vet market. So I think we're in an excellent position. But if we can work out a deal with one of the majors, I think that would be very good for us and good for them. But if for any reason we don't, then we've shown the ability we can launch ourselves. So I think it's been an absolute win-win all around.
spk09: Thank you. And then I'd also like to ask about mitosis, specifically mitosis outside of COVID-19, because, I mean, you really need a bit of a crystal ball to determine where the pandemic is going. So what's the size of the opportunity for mitosis? other net associated diseases, you know, in terms of something like sepsis or influenza or any of the other ones?
spk02: I'll let Jake answer that from a more technical point of view, but I think my non-technical word would be absolutely massive, bigger than cancer. Sepsis is the biggest killer in hospitals, and it tends to kill you because you don't know it's coming, and also there's very few actual therapies for it. So we're working with a range of groups who've been working on therapies for a while, and The spotlight from COVID from the ptosis has certainly allowed them to really progress like Santersis, their therapies. So I think it's potentially as big or bigger than the other things we do. Why is that? Sepsis, as I said, it's very hard to actually know, to measure the nets and the advancement as disease progression. It's very hard to know a prognostic and it's very hard to treat at the moment. And part of the treatment issue is if there's nothing good as a companion diagnostic, then it's very hard to have a treatment because if you can't monitor it, the first thing you've got to know is if you have too many nets because, as Jake points out a lot, the nets are actually very good for you until they're not. So you don't want to be removing someone's primary defence mechanism unless it's really in excess. So I think for all those reasons, our assay has, in the evidence we've shown recently in a range of different studies, ours works extremely well in the diagnostic disease monitoring process. and disease progression. And we're hopeful from what we've seen also from prognostic. So, well, that's not a scientific term, massive, but we're working through that now. But it could be something which you give a lot to everyone who comes into hospital because if sepsis, as you said, creeps up on you and it can kill you very, very quickly, knowing that your nets are building up would be incredibly useful. And I think we've certainly got a solution and it's certainly low cost, easy to use. And so I think we could be a big part of it. Jake, do you want to answer that more scientifically perhaps?
spk04: Hi, Jason. Well, first of all, NETS is a huge area. It's not just COVID. So I think if you are talking to people working in intensive care in COVID, they're now completely talking about NETS all the time. And NETS has sort of exploded as a subject in medicine today. And talking to people in intensive care, I have literally had conversations that go like, if you talk to people in our hospital a year or two ago, nobody would have heard NETS. This is clinicians. And now everybody's talking about NETS. And so COVID has really woken up the world to NETS and their role in all sorts of diseases. And COVID has sort of cleared the path, but actually it's not just COVID. As Cameron mentioned, NETs are what drives the pathology in sepsis, and sepsis is the biggest killer in hospitals worldwide. It's also, these are just examples, it's active in all sorts of areas of diseases that have other names, but the underlying driving factor is or one of the main driving factors is NETS in every case. So a lot of people with cancer actually die of thrombosis and thrombosis is what actually kills you in the end. NETS drives thrombosis and microthrombosis. NETS drives a lot of strokes and lung blockages. NETS drives a lot of the amputations that occur in very bad diabetes cases and all sorts of varieties of other autoimmune diseases, the actual very bad symptoms when these diseases flare are also related to NETs. So whilst COVID has sort of shone a light, if you like, on NETs and made everybody aware, actually they have a much wider role. And COVID has shone a light simply because it's, you know, such a high mortality rate and so clearly associated with NET. But it's shone a light on the problem, which is much wider than that. So we've opened a NET division within the company to take advantage of that situation. And COVID is a huge, hopefully temporary opportunity, but the opportunity is much, much bigger than COVID.
spk09: Thank you, Jake.
spk02: It couldn't possibly be bigger. Sorry. Thanks, Chase.
spk09: I was just going to say I really appreciate the thorough answers. One more quick one, if you don't mind. I want to ask about the proof of concept study and DLBCL. How does the trial design compare to to the large regulatory study, at least for that, you know, DLBCL leg, and can this be used potentially as a read-through for that first data readout and potential filing in blood cancers?
spk02: Yes, actually, that's probably a question for Jason, who's our expert on that. Could I have him call in on the... if we have a call afterwards? He's an expert in all those. I don't want to make any answers, which perhaps could be incorrect, unless you... Would know that, Jake, or should we leave that to Jason?
spk04: No, I think it's better if Jason answers that.
spk02: Sorry. Jason has organized all these trials, and he's spent a huge amount of effort studying all the different types of NHLs, so it's probably better if I don't go off-piste and try and answer that, if that's okay?
spk09: No, there's no problem. I'll talk to you guys later. Thank you for taking my questions. Thank you.
spk06: Next question is coming from the line of Nathan Weinstein with Aegis Capital. Pleased to hear your questions.
spk05: Hey, good morning, and thanks so much for taking my questions. So maybe just looping back to the veterinary market, you know, the beta launch going on in new QVET, you've shared some of the feedback and obviously discussed some of the revenue opportunities, but maybe you could just dive in a little more on the color you're hearing from the veterinarians in terms of any anecdotal feedback that you're getting.
spk02: Yes, I think obviously there's a lot of things we've been learning. Some of the feedback on the fasting, going for smaller fasting is very helpful. Shipping, we're looking to perhaps have provider packaging for them to make it easier for them. Also, while we're also talking to the big partners, if they could just drop it into an envelope with all the other blood tests, that would be easier for them than shipping it to a separate lab. But I think as we've talked about, there's absolutely nothing else out there So it's been a lot of education as well. And there's a lot of discussion whether it's a cancer test in a sick dog or what I think is more likely, it's actually, and the biggest market of all, is where you're testing as part of the wellness test for dogs. I think a large percentage of dogs in the US get a wellness test every year. And I think that's where we'll end up positioning ourselves. But that's all in the process now. And so there's been a lot of work. Also, there's been a lot of interest in treatment monitoring. I think you remember Heather presented a small amount of data showing that it worked very well for that as well. And there are millions of cases of these cancers every year, and the current methods of monitoring treatment are very average at best. So there's been a lot of feedback that that would be very, very useful. We've also been working with, we said we've been in discussions with some of the bigger companies We're discussing pricing quite heavily too. What would the discounting in price mean for extra sales? I mean, our ambition is to have millions of tests sold per year at what kind of price point. Obviously, you don't want to sell it cheaper than we need to, but also we'd like to have it as widely accepted as possible. So we're just looking through that at the moment and trying to work with our own team in Texas and our own feedback team as well as with some other groups if they were to work with us launching what the optimum pricing would be to really, our aim in all this has not to be made, not to have a small number of tests at a high value, but try to make it really, really widely adopted. So yeah, the pricing's been a big discussion, and all the logistics, and also there's been a lot of feedback on the monitoring of treatment for these cancers would be very, very useful. So that's probably the next product off the rank, which should be in the short to medium term as well, And I think that would also be very, very well accepted. So it's a whole range of things. And there's quite a lot of things in the mix there. But I'd like to reiterate, when we say beta testing, it's not the actual product itself. That has worked incredibly well. It's doing exactly what it should be doing to vary all the feedback, not just in the vet space, but all the human space when we've shipped it to a very wide range of groups. They're all incredibly impressed of the analytical validity. It's measuring exactly what it should be doing. It's very reproducible and very robust. So the rest is all the product launch things we're learning. Does that make sense?
spk05: Yeah, that's great. Thank you, Cameron, for covering that. And, you know, Volition overall has been a really nice engine of innovation across all the areas and human and vet and the work that Jake and the rest of your team is doing. It's really quite exciting to watch. And then I guess just sticking with the theme of vet here, when we think about, like, all the learning that you're getting from this beta project, Do you think you will build out the product portfolio and have some more products in adjacent areas within the animal health space?
spk02: Oh, absolutely, undoubtedly. So I think the easiest ones to launch next, and with the feedback we've been listening, is on the monitoring of disease or the treatment monitoring. And that's something which is quite easy to do with what we have, and we've had some very encouraging data. not enough to launch a product but that's something Heather is collecting now so we're hopeful we can really broaden that out in the next few quarters as well. Obviously there are other cancers which we're working on and as we've discussed before the incredibly exciting thing about what we do is the nucleosomes are not just preserved between human and dogs but every species so the big vet companies are trying to get cats notoriously prickly in coming into vet offices so they're trying to find reasons to get cat owners into the vet as well. And so I think there's potentially a big market in the cat market for, and it's obviously from all the things we've seen that the nucleosomes are not just cancer, there can be a lot of other things as well. So I think this is the starting gun, not the finishing line in the range of products we can launch. And I think also I mentioned it briefly, but we're also looking to greatly strengthen the team in the vet side too. We've been doing it with the volition team, but we really want a commercial focus from the vet space. So Expect to see in the short term some key hires to really drive VET as a separate entity within Volition, but as a separate entity. And that would help us to really expand, not only internationally, I think the Asian and the European launches are something we'll be doing in the medium term as well. And I think we'll not just go to dogs, but a range of other species. Not this year, but in the coming years, because it is exactly the same platform. It just comes down to some slight adaptations, certainly between humans and dogs, and we'd expect the same for cats. And then you can go into veterinary animals and the larger animals. So I think it's going to be a very big story.
spk05: Thanks, Cameron. As a dog owner, I'm glad you started with dogs and now with cats, and I appreciate the call there as well.
spk02: Thank you.
spk06: Any other questions? Yes, our final question is coming from Bruce Jackson, Benchmark Company. Please proceed with your questions. Thank you.
spk07: Hey, Cameron. You touched on the NUQ capture. You touched on the NUQ capture program, and I just wondered if you could maybe give us some highlights and if the next data reads can be on the circulating tumor cell program.
spk02: Yeah, actually, thank you. We didn't put it in this call because obviously it's a lot happening. So again, we were focusing on the product launches and everything else we're doing. So we've taken on a small team in the U.S. Why in California? That's where the hub of a lot of epigenetics is. So to get the best people, we thought a small team there doing a lot of this would be very helpful. So just a quick recap of where we are. This is something also, we have the four pillars we always talk about. The VET is pillar one and pillar, well, one of the pillars, the human cancers and the ptosis are the three pillars apart from CAPTCHA. So we showed last year that we could separate long from short nucleosomes and what it is from just for everyone else's benefit is now that the antibodies are on a magnetic bead, you can pull out the nucleosomes to be analyzed. So once you have the nucleosome, you also have the DNA. And we showed we could separate the long from the short DNA. Who cares? Why is that interesting? The short DNA has been shown to be where the cancer DNA nucleosomes are. So potentially a fantastic enabling technology for everything in liquid biopsy space. Once you also have the nucleosome, you also can do mass spectrometry. And actually, that's gone very, very well. And we've been working with our collaborators And there's a paper in the offering on showing how well that works as well. And that's also potentially a service. We're the only group that can actually do all this and do the mass spectrometry. So again, part of the revenue we're looking to do is things through servicing. From Silver One, this is another source of it. So from the actual concentration of the nucleosome site, we did it, but like anything we've done before, sometimes it works better than others. So we realised We kind of pressed pause on driving forward and we went through a re-optimization process like we've done for the assays, like we've done in everything we've done. So we went back and just pulled it apart to make sure everything was fully optimized from the coating of the beads to actually using the antibodies which can actually be mass produced, all the things that would need to be a product and a service. So that's gone very, very well. We'll have a lot more data on that coming to the The final stages of the process of that from the sequencing side, the mass spec is actually looking very good and that's already in publication ready. So I think that's something we'll have news on certainly this year and hopefully sooner rather than later this year. On the key aspects of it, which is, and there's three key aspects. There's the sequencing side, there's the mass spectrometry side, and then there's the transcription factors. And I think the team has done an excellent job at optimizing all those It's one thing to have showing something works. It's quite another to have it ready for a product. So that's what they've been doing, and I think they've done an excellent job. Jake, is that how you'd say it?
spk04: Yeah, I think all of that's spot on. And the guys in California have made great strides towards changing it from being something that clearly can work to something that does work every time.
spk02: Does that answer your question, Bruce?
spk07: It does. Congratulations on all the progress and thanks for taking my question.
spk06: Thank you. Anytime. Thank you. And gentlemen, I'm going to turn it briefly over to Scott. He has heard from an answer. He has an answer for you. Go ahead, Scott.
spk01: Oh, hi, guys. Just regarding Michael's question earlier, I just heard back from Jason Terrell about the blood cancer study. Michael, to answer your question from earlier, I'm going to quote from Jason. The DCBCL POC study is a treatment response monitoring test, whereas the larger 1,500 study is an aid to diagnosis of the disease, so the readouts are not related. We also hope to have the treatment response data in the coming months as the study has almost been completed. Hopefully that answers your question, Michael.
spk06: Thank you. I'll turn the call back to Cameron for closing remarks.
spk02: Thanks, everyone. Obviously, a lot going on. It's been a very interesting year for everyone. I'm sure we're all adapting to working from home. But I think from everything we've done and everything we have been, we've had a fantastic year. not only in the capital raising side, but also the product side, development side, the team. It's all worked out incredibly well. And I think this is just going to be an absolutely fabulous year. It's been a real pleasure working with the team that we've managed to get all this done with. And the next few quarters, I think we're just going to be picking up speed. And we're going to be focused as much as we can on making sure all the green shoots of revenue in all the different areas, we continue to grow. And we make the company of a lot of varied revenue streams and also all the very exciting research and development at the heart of epigenetics. So thank you for your time.
spk06: Thank you. This will conclude today's conference. You may disconnect your lines at this time, and we thank you for your participation.
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