VolitionRx Limited (VNRX) Q4 2020 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited's Fourth Quarter and Full Year 2020 Earnings Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be opened for questions. [Operator Instructions]. This conference is being recorded today, March 23, 2021. I'd now like to turn the conference call over to Mr. Scott Powell. 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. Terig Hughes, our recently appointed Chief Financial Officer; and Dr. Jake Micallef, 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?

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 done by all of our teams over the past few 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 the middle operational and opened the new Silver One production facility and indeed have made such ways of significant progress into 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 the Terig, 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 and a reminder of all the progress we have made in the last year. We have traded this year strongly, especially by closing our acquisition of Optima in January and then by launching our first product the Nu.Q Vet Cancer Screening Test in Decemberand 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 Nu.Q tests,the recombinant nucleosomes, which we use as the calibrants.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 Nu.Q test. 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, most of Nu.Q Vet Cancer Screening Tests with Texas A&M. This is all a truly fantastic team effort and refocusing on near-term product launch opportunities during the pandemic show the amazing flexibility of our platform and team. This flexibility is a key aspect of our success. Throughout the year, we, as always, continued to strengthen our large intellectual property portfolio, with additional patents being granted and new patent application submitted, including in relation to the use of Nu.Q technology in NETosis, COVID-19 and other diseases. And we now hold 64 patents worldwide, with a further 90 patents pending. We also published and/or presented at a number of conferences, most notably at ASCO 2020, with various abstracts featuring performance data on our Nu.Q technology with respect to lung cancer and blood cancer, as well as performance data for Nu.Q Capture. At our Virtual Markets Day in October we announced our commitments to two lung cancer studies both to be conducted in the U.S. 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 DLBCL. Both studies are now underway, which results from the treatment response study expected later in the first half of this yearand likely the first read out from the NHL regulatory or 510(k) 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 introduce our new Chief Financial Officer Terig Hughes, who 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. Terig, great to have you on Board, over to you.

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 2020reflecting 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 NETosis. 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 act 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 aftermarket equity distribution program. Furthermore, in January, we were delighted to announce the award of approximately $4 million in non-dilutive funding from the Walloon Region, and Namur Invest. 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-dilutive funding, including this most recent award. We would like to publicly thank Willy Borsus, Vice President of the Walloon Government, the Walloon Minister for Economy, as well as Nicolas Delahaye and Renaud Hattiez 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 totalled 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 an average approximately $1.5 million per month. Overall, we would expect it 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.

Thanks Terig, and I'm absolutely delighted to have the strongest balance sheet we've ever hadand great to have you on Board. In fact, while talking of the team members, I'd also like to publicly welcome Ms. Gael Forterre, our new Chief Commercial Officer, to our executive management team, as well as congratulate Gaetan Michel for his promotion to Chief Operating Officer and Dr. Mark Eccleston, one of our founding advisors 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 are proud 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 for our management team. Also, from an expansion point-of-view, we're absolutely thrilled to have opened Silver One, 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 Namur Region, again helping to keep our burn rates relatively low. We are well into the process of producing at large scale, raw materials such as recombinant nucleosomes, which act as calibrantin our Nu.Q assays, in addition to antibodies that are key elements to our branded products. And indeed, we’ll manufacture our full diagnostic kits once finalized. We expect to offer all elements for both commercial sale and for clinical trial purposes, and CE-Marked 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 processingfor Nu.Q Vet in Europe, more on this a steplater. The opening of our new Silver One facility that brings manufacture of key components in-house, thereby securing our supply chain, but it also should definitely 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 our road for diverse revenue stream. Speaking of revenue, I was delighted to have appointed our first sales manager in Europe, Emmanuel Demillecamps, he 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 focus to help drive revenue from our Silver One facility. Emmanuel has been hard at work,at generating initial revenues from 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 organizational 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 Volition America Inc. that focuses on blue-sky innovation and discovery research, which we hope will help us leap forward on some of our cutting edge research projects and so to our first product and revenue. Many of you have followed and support 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 Nu.Q Vet Cancer Screening Test shortly after our 10-year company anniversary in the fourth quarter of last year. This is an extremely important milestone for the Company.Asthis 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's a high suspicion of cancer. It may also be a complementary test for younger dogs or breeds at high risk for developing cancer in their lifetimes, such as Golden Retrievers. The test is currently available only from the GI lab at Texas A&M University, with the beta launch focusing on veterinarian across Texas. So what is the beta launch exactly? The beta launch is to facilitate real world learning from actual customers paying for the test to help drive the marketing mix before we launch nationally across the U.S. as expected in the next few months. It also gives us a chance to showcase the product to the large multinational vet companieswe are in very active discussions with which if concluded successfully would help greatly accelerate launches and sales worldwide. Even this is our very first commercial launch. We are using Texas as a test market to make sure all aspects of our products are properly tested before we launch in the U.S. nationally and worldwideand to help us address beforehand any issues that companies who may end up pivoting or licensing out vet products. We are gaining extremely valuable feedback on the 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 veterinaries in Texas about Nucleosomics and raising the general awareness of the Nu.Q Vet Cancer Screening Test. In terms of the commercial opportunity and addressable market, cancer in dogs is widespread. It is the leading cause of deaths in dogs over the age of 10, and there are over 6 million new dog cancer diagnoses in the U.S. alone each year. As cancer screening is not a commonplace in the animal health as it is in human health, we believe blood test like the Nu.Q Vet Cancer Screening Test will help to transform how veterinaries 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 Nu.Q Vet Cancer Screening Test is a simple, low cost, easy-to-use ELISA based blood tests, which we believe will help streamline the screening process for up to one-third of malignancies in dogs, including common malignancies, such as lymphoma and hemangiosarcoma. We recognize the desire to receive revenue guidance now, that we have 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. Sufficed 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 have received the first product for our kits from the GI lab late last year, and since then, they’ve reordered kits twice already this year. In addition to the Texas beta launch, today with 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 are at the very beginning, but we believe that it’s 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 Nu.Q assays could help identify non-cancerous nodules following a 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 a widely accepted standard of the screening of individuals at high-risk of lung cancer. However, LDCT has several limitations, including poor specificity, which means high false positives. Results of this study suggest that nucleosomes and histone PTMs may discriminate well between non-cancerous benign nodules versus very early stage lung cancers, stage zero, stage one, stage two, 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 dirtiest of all the cancers, and there was a high unmet clinical need for improved diagnosis. We are hopeful that our Nu.Q assays can help and are delighted that our world renowned collaborators presented this data at such a prestigious conference. We share our collaborative excitement to complete the study and report the findings at time it becomes as later this year. And if it continues to go well, we’ll have our 510(k) regulatory study in the U.S. like we have in the blood cancers. We've also made great progress on the research program for the use of our Nu.Q technology in NETosis. And in particular, in monitoring disease progression of COVID-19 and sepsis and as announced early this week, as a potential companion diagnosticfor treatment of sepsis, and are looking to broaden this further into influenza and potentially other diseases associated with NETosis. To add a bit more color to this discussion, as this is a new and very exciting use of our Nu.Q platform, and to provide some of the science behind this, I'd like to introduce Dr. Jake Micallef, our Chief Scientific Officer.

Good morning, 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 NETosis. 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. NET is therefore is a crucial part of the immune system. However, over production 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. NETsare 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. TheNETs material is made up of nucleosomes. I am bullish tohave 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 Nu.Qnucleosome assays. Indeed I believe are assays are the only analytically validated quantitative nucleosomesassays currently available. We're investigating the use of the Nu.Q platform to monitor NETosis disease progression, and frequent response across a wide range of diseases that involve the over production of NETs. Last year, we showed thatnucleosomes that were strongly correlated with disease severity in the first wave of COVID-19 patients.Patients admitted to hospitals at higher levels thanpatients with mild disease, patients requiring intensive medical support and intensive care units at higher levels of nucleosomes thanpatients admitted to regular hospital wards, and patients who died at even higher levels of nucleosomesthan 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 predicted our test is. This has taken longer than we expected,as the hospitals we're working we have understandably been focused on caring for the very high numbers of patients admitted during the second wave of the virus. We will announce later from human COVID-19 and sepsis studies over the coming quarters. In addition, we are releasing data from an animal study of sepsis this weekin a presentation by Dr. Andrew Aswani, a consultant in critical care and anaesthesia at one of London's leading teaching hospitals. This small initial study looks at the use of Volition’s Nu.Q NETs assay to more as a 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 pigs. The results showed that the treatment was successful and that our Nu.Q assay was the best and most practical way to measure the NETs 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 NETosis drugs, both in relation to treatment monitoring, and for use as a companion diagnostic for patient selection.While NETosis 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 Nu.Q platform. We informed our Nu.Q NETs team to provide increased focus and drive to the product development program. It once again underlines the strong breadth of the Nu.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.

Thanks a lot,Jake. Exciting times indeed and so to the future. I would like to reiterate our vision and what makes us satisfied with the progress and our sight. 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 Nu.Q platform at the very heart of epigenetics. We believe the last decades of work at Volition with our ever expanding team in epigenetics puts us in an extremely strong position with our expansive IP portfolio, to bea significant player in this key field. Overall, on so many fronts, with our ever growing team and IP, I'm 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 about the Company's future opportunities. We aim to report throughout 2021 and beyond numerous key milestonesnow 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 Nu.Q Capture, which I’ve not discussed at length today, but is also making very strong progress;five, along with the rest of the Board, and indeed the whole company, look forward to sharing the results of case studies over the coming months and year with our optimized platform. Despite the pandemic, 2020proved to be a most exciting year, thanks to our fantastic hard working team. But we are 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?

[Operator Instructions] Thank you. And our first question is from the line of Kyle Mikson with Cantor Fitzgerald.

Just regarding the NETosis 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 for some of those diseases like COVID, influenza, sepsis, or will just one be examined in the file? And then second, is it possible that the trial could assess treatment monitoring with NETosis 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 a [complication] 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.?

And just some very good questions. I'll answer those briefly myself, and then see if Jake has anything to add. So, yes, of course,so the first question, really, I guess, pertains to whether we do a separate NETosis trial for COVID for influenza and sepsis. We've 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 sepsisbecause it's a very, very -- because, it's what kills most people in hospitals.Obviously, 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 that's sort of overwhelmed hospitals at the moment. So while we are in the U.S., we're looking to do a large trial, which is the third question. It's -- probably it'll be about the same cost we'd expect as the other 510(k)s. But when you're doing longitudinal samples, which this would probably be,you have a probably the similar number of samples, but less patients, if that makes sense,because you're looking to get four or five samples from these patients. So it would be a very similar scale of trial, the exact numbers you need for longitudinal studies we're still working on. But I think we'll end up with a product for NETosis, which will work in sepsis we expect and hope, we'll see how it goes. But that's -- all the things we've seen now are extremely encouraging. So -- and that would be useful for all three. So we're just debating at the moment, whether -- the first half of the length if you will would go for a one on -- for influenza and the COVID, or whether we would look to do one in sepsis. But sepsis is probably the big market, it's probably 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, Jake can confirm this, but the trial for the drugs would be a separate one, because obviously that's -- it's not diagnostic or prognostic or disease progression. This would actually -- this is companion diagnostic. So as you saw, we had fantastic data with Santersus.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've had 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 is the Santersus 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 Jakecan confirm all of this, but it's incredibly exciting to be at the heart of all of this as well as cancer in the Vet space. Jake, did I get that right? Anything you would like to add?

I think you got it 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 disease all that is going very well, and probably as Cameron say, that beginning it will be sepsis or COVID, and later on we might be able to look actually at NETosis as an indication itself.

And I think it's important to just reiterate, it has taken some time. We were hoping some data late last year. But as you just said a few times, it's very understandable that, some of the trials that longitudinal studies have been tough during the emergency ward is overwhelmed taking 10 samples from one patient is not their top priority, quite, quite naturally, and quite rightly. But I couldn't express strongly, too strongly how happy you are with the results and how collaborators are really appreciating not just how well the data is coming out, but also how well our assay has performed, all the work we've done and now it means we can ship kits to a range of places where they can be run and they're just working tremendously well. But in doing what they should be doing, and also just being robust and reproducible, reliable. So, I think we 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 there's going to be a big part, and one of our four key pillars of the Company going forward. Because yes NETs is, only recently understood, but I think we can be really at the heart of the treatments as well as diagnostic, prognostic and disease progression for NETosis as well.

Okay. That was great. Thanks so much, Cameron. That was comprehensive answer there. And I just wanted to switch to the breast cancer screening products. On the beta launched in Asia and Europe, really encouraging to hear you guys kind of, one-on-one try to get obviously some pretty large. I know it's still pretty early on, honestly, what's the general plan looks like with marketing distribution? And do, you already have relationships with some sites I guess in Asia and Europe, maybe similar to what you have in the U.S. with Texas A&M, and then again another difficult question to kind of answer at this time, but when did the launch maybe occur? Is that more a 2022 events, or could that possibly happen in the back end of this year? Thank you.

It's a very good question. So, yes, we've actually obviously got a strong footprint in Europe and in Asia. We're very hopeful, it will be this year and actually it could be reasonably soon because we're doing a lot of work on this. We'd like to do better. The same we're learning in the U.S. We can use a lot of them, obviously in different markets, but every market is a bit different. We're in quite the best discussing -- and restarting in Singapore because that's where we are. And you can learn a lot of lessons in a place like this. I like to Singapore and then use that for other markets. So, I'd expect that, in the short to medium-term. In Europe, we are actually very active as well and looking perhaps for a slightly different model. We've been shipping kits to Texas's GI lab, but we actually have our own lab in Belgium now still one, the famous. So, yes, one option where it's sprawling very seriously is actually that's becoming the equivalent of the lab to the GI lab in Texas. So, then we could be running the samples as well. And that's the way we can also do this right in the heart of Europe, it's easy place to ship to obviously Belgium drive is very well located and we are the best of running the test ourselves. So, I think that the three main ways of generating revenue from the Vet space, we're actively looking at activity. That's the kits 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, we run the tests at the contracted out or when we set up ourselves. And also I think we really should emphasize what was -- 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 taking much more seriously when you run the product yourself, you so it works. We're not testing the product and product has worked absolutely perfectly. We're testing the marketing and logistics. And all those lessons are very helpful for the bigger companies as well. I won't mention the names on the call, because but they're only two big companies. And we're in very active discussions with both for different reasons. And that could really turbocharged the revenue, if we ended up doing something we couldn't get with them. They each have hundreds and hundreds of salespeople throughout the U.S. and worldwide. So, I think it's very fair to say I'd be I'd be upset if we didn't, 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'll be a mix of all three, what our platform really allows us to do with all three, we can tell kids, we can do it as a service. And we can license just direct out but still selling our key components. And I'd expect all threes to have a strong component worldwide. So yes, this has been happening below the surface. And obviously, we can't say anything until beyond that until it actually happens. But I'd expect to see a lot of progress on all these punches here. And the beta testing has been the beta launch and all the testing we've been doing, it's been completely invaluable. We still think of what we've said before, it's a market that could absolutely change the way religion is seen. And then generate a lot of revenue. So, we're taking it very seriously. And you'll see a lot more news in that in the coming months and quarters. Did that answer your question?

Yes, I think that was great. Thanks a lot. Cameron. Just one last question for me similar line of thought, maybe on the expansion in the U.S. with the best test. So, I guess, how are you evaluating some of the markets that you want to expand into? Like, what you're evaluating marketing mix, I guess, right. So, what, what have you seen so far with respect to how different marketing channels are, how they're responding when the feedback has been to your efforts thus far and yes, just everything about the, the expansion in from the U.S. really, and what I don't know, what can we expect maybe over the next few months or so this? This broad, high level kind of comments would be awesome? Thank you.

Yes, absolutely. So, we're looking now, obviously, the, all those key lessons pertain to we wanted to get right before we launched nationally, they sound boring and things but logistics are very important whether we've had feedback that lead fastening is better. We're doing tests now to see if we can bring that down from eight hours to four hours. And it's not doesn't have to be overnight whether you can ship with testing also just overnight on rather than freezing. All these kind of things a bit for us what a marketing mix looks like actually, what I think depending on whether we do end up doing a deal with either or both of the major players, because it's part of doing a deal with one of the major players stick in the U.S. is they would really lean into the public awareness in the marketing. So, obviously, anything like that would be a much bigger market, we'd get a slightly smaller share, but of course or but you would you do that because it won't correctly. The only reason -- 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 U.S., and 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 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 was how we'll go forward.

Next question is from Jason McCarthy with Maxim Group. Please proceed with your question.

Just on the size of those Texas A&M or is because you mentioned that there were three additional in 2021. Were those based on the demand they're seeing are really more expected as they build up their supply for the launch?

It's completely based on demand. So they say from the accounts, it was a little over $7,000, which equates to four kits, which if they use every place, I would say they don't, because they have to do some repeats in humans, 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's some time between recordings. 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 been sorted out with, we thought the best way to really learn all these things is to actually have real paying customers, there's dozens of bits of auditors, Texas A&M have given us great feedback, it's 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 yes, so the audit 7000, which is about 160 times and then we audit, it was three times last week, and that was three times. And they just keep reordering about let say, I guess really adjusting I'm ordering as they finished up 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 where we've done a bits and pieces with the key opinion leaders and throughout Texas, but obviously nothing nationally. So this is the kind of 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 up enough headroom for the international and national launch. And also, again, I think it's really focused the mind on the big companies that 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 will be lots of wasn't a 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 NETs 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's would be very good pressing good for them. But if for any reason we don't, then we find the ability we can watch ourselves. So I think it's been an absolute win-win all around.

And then I also want to ask about NETosis, specifically NETosis outside of COVID-19, because I mean, you really need a bit of a crystal ball to determine where the pandemic is going. So as to look at the size of the opportunity or other NETosi diseases in terms of sepsis or influenza or any of the other one?

I'll let Jake get to that from 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 what's coming and also there's very few actual therapies for it. So, we're working with a range of groups who have been working on therapies for a while and the spotlights from COVID from NETosis is certainly allowed them to really progress like NETosis the therapies. So I think it's potentially as big or bigger than the other things we do. Why is that? Sepsis is that it's very hard to actually know you have to measure the net and the investments as disease progression, it's very hard to know, prognostic and it's very hard to treat at the moment. And part of the treatment issue, if there's nothing good as a companion diagnostic, then it's very hard to have a treatment, because you can't monitor. The first thing you've got to know is if you have too many units, because as Jake point 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 defense mechanism unless it's really in excess. So I think for all those reasons, our assay has in the evidence we've shown recently, and in a range of different studies, ours works extremely well in the diagnostic disease monitoring and disease progression. And we're hopeful from what we've seen also from prognostic. So that's not a scientific method, 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 as you say creeps up on you, and you continue very, very quickly. Knowing that it's the net-net to 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 can be really proud of it. Jake, do you want to answer that if you want to scientifically, perhaps.

Well, first of all, NET is a huge area. It's not just COVID. I think if you're talking to people working in intensive care in COVID, they're now completely talking about NETs all the time. And NETs is sort of exploded as a subject in medicine and talking to people in an intensive care. I've literally had conversations that go like, if you talk to people in a hospital, a year or two ago, nobody would have heard NET. This is clinicians and now everybody's talking about NETs. The COVID has really woken up the world to NET down there and their role in all sorts of diseases. And COVID has sort of created 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 the biggest example it's active in all sorts of areas of diseases that have other names, but the underlying driving factor and one of the main driving factors is NET in every case. So a lot of people who tend to actually die from thrombosis and thrombosis is what actually [indiscernible] NETs drive thrombosis and micro thrombosis and NETs drives a lot of strokes and lung blockages. NETs drive 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 shown life if you like on that simple and made them everybody aware actually they have a much wider role and COVID has shown a lot simply because it's such a high mortality rate and so clearly it shown a lot which is much wider than that. As we move to NETs division within the Company to take advantage in that situation and COVID has huge hopefully temporary opportunity, but the opportunity is much, much bigger than COVID.

Thank you, Jack.

Thanks sir. I was going to say, I really appreciate the thorough answer. One more, quick one, if you don't mind. Want to ask that the proof-of-concept study and DLBCL, how does the trial design compare to the large regulatory study at least for that DLBCL? And can this be used potentially as a read through for that first data read out in potential filings of blood cancers?

Yes. Actually, that's probably a question for Jason, who's our expert on this. Could I have him call in, if we have a call afterwards? He is an expert in a way that I want to make any answers, which perhaps could be incorrect, unless you would know that Jake or should we leave that to Jason?

No, I think it's better Jason answer that.

Okay. All right. Jason has organized all these trials and he spent a huge amount of effort to studying all the different types of NHL. So, it's probably better if I don't go with that, if that's okay.

There is no problem. Thank you for taking my questions.

Next question is coming from the line of Nathan Weinstein with Agesi Capital. Please proceed with your question.

Hey. Good morning and thanks so much for taking my questions. So, maybe just looking back to the veterinary market and beta launch going on in Nu.Q Vet, you shared some of the feedback and obviously some of the revenue opportunities. But maybe you could just dive in a little more on the color here from the veterinarians and sort of any anecdotal feedback that you're getting?

Yes. I think, obviously, there's a lot of things we've been learning from of the feedback on the fasting, going for smaller fasting is very helpful. Shifting, we're looking to perhaps provide a 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 easy for them in shipping it to a separate lab. But I think as we talked about there 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, and a sick dog or what I think is more likely is that it's actually have the biggest market of all, is where you're testing patinas at part of the wellness test for dogs. I think a large percentage of dogs in U.S. get a wellness test every year. And I think that's where it will 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 on average are best. So, there's been a lot of feedback that that would be very, very useful. We've also been working with everybody in discussions with some of the bigger companies, but it's stopping pricing quite heavily too, what would the discounting in price mean for extra sales? I mean, our ambition is to have millions of test sold per year, at what kind of price point. Obviously, you don't want to sell it cheaper than, than we need to. But also, we'd like to have it as widely accepted as, as possible. So, we're just looking for that at the moment. And kind of work with our own team in Texas and our own feedback, 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. And all this has lots of made thought to have a small number of tests at a high value, but try to make it really, really widely adopted. So yes, the pricing has been a big discussion and all the logistics, and also, there's been a lot of feedback on the monitoring of treatments for these cancers would be very, very useful. So, that's probably the NETs product of the rank, which shouldn't 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 mixed in. But I'd like to reiterate when we say beta testing is 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 NETs space, but all the human space, when we've shifted to a very wide range of groups. They're all incredibly impressive. The analytical validated validity is measuring exactly what it should be doing. It's very reproducible, very robust. So, the rest is all the product launch things we're learning. Does that make sense?

Yes, that's great. Thank you, Cameron, for covering that. And, Melissa, overall, it's been a really nice engine of innovation across all the areas in human and NETs and the work that Jake and the rest of your team is doing was really quite exciting to watch. And then I guess just sticking with the theme of that here, when we think about like all the learning that you're getting from this beta, do you think you have will build out the product portfolio in that and have some more products in adjacent areas within the animal health space?

Oh, absolutely, undoubtedly. So, I think the easiest ones to launch NETs, and where the feedback would be 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 look for products. But that's something Heather is collecting now. So we're hopeful we can really broaden that out in the kind of in the next few quarters as well. Obviously, there are other cancers, and which we're working on. And, as we've discussed before, they're incredibly exciting thing about what we do is the nucleosomes are not just preserved between humans and dogs, but every species. So, the big NETs companies are trying to get cats, notoriously prickly in coming into NETs offices. So, they're trying to find reasons to get cat odors into the NETs as well. And so I think there's potentially a big market in the cat market for obviously, from all the things we've seen that the nucleosomes is not just cancer, there can be a lot of other things as well. So, I think this is the starting guns, 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 great interest from the team in the NETs side, too. We've been doing it with demolition team, but we really want to commercial focus from the Vet space. So, we expect to see in the short-term. Some key is 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 European launches, something we'll be doing in term as well. And I think we will 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 in the larger animals. So, I think it's going to be a very big story.

Our final question is coming from Bruce Jackson with Benchmark Company. Please proceed with your question.

You touched on the Nu.Q 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?

Yes, 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 habit of a lot of epigenetics is to get the best people, we thought a small team they're doing a lot of this will be very helpful. So just a quick recap where we are, this is something also, we have the four pillars, we always talk about the Vet with pillar one and one of the pillars, the human cancers, and the basis are the three pillars apart from capture. So we saw last year that we could separate long from short Nu.Q zones. And what it is from just for everyone else's benefit is now that the antibodies are on a magnetic base. You can pull out the Nu.Q firms to be analyzed. So once you have the nucleosomes have the DNA and we showed we can separate the loan 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 and liquid biopsy space. Once you also have the nucleosomes, 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 the tray, how all that works as well. And that's also potentially a service where what the other group that can actually do or listen to the message from a tree. So again, out of the revenue, we're looking to do with things with everything from Silver One this is another source of it. So from the actual concentration of the nucleosomes side, we did it but like anything we've done before, it's sometimes it works better than others. So we realized, we kind of press pause on driving forward, and we went through a real optimization process like we've done for the assays like we've done 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 service. So that's gone very, very well. We'll have a lot more data on that. They're coming to 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, hopefully, sooner rather than later. And the key aspects of it, which is and the 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 throwing something works, it's quite another to have it ready for a product. So that's what I've been doing. And I think they've done an excellent job. Jake, is that term, have you seen?

Yes, I think all of that spot on and the guys in California have made strides towards changing it from being something that clearly can work to something that does work every time.

Does that answer your question?

It does. Congratulations on all the progress and thanks for taking the question.

Thank you, and gentlemen I wanted to briefly over to Scott. He has heard from an answer his answer for you. Go ahead Scott.

Hi, guys just regarding Michael's question earlier. I just heard back from Jason Terrell about the blood cancer study. So, Michael, came through your question from earlier, I'm going to quote from Jason. The VC, DC or PLC study, there 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. Hope that answers your question.

I'll turn the call back to Cameron for closing remarks.

Thanks, everyone, obviously, a lot going on. It's been a very interesting year for everyone. I'm sure we're all working from home. But I think from everything we've done and everything we have been, we've had a fantastic year, not only on 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 absolute fabulous year. It's been a real pleasure of working with a team that we have we've managed to able to 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 different areas. We continue to grow and we make the Company have a lot of varied revenue streams and also all very exciting research and development at the heart of epigenetics. So thank you for your time.

Thank you. This will conclude today's conference. You may disconnect your lines at this time and we thank you for your participation.