VolitionRx Limited (VNRX) Q1 2020 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the VolitionRx Limited First Quarter 2020 Earnings Conference Call. During today's presentation, all parties will be in listen-only mode. Following the presentation, the conference call will be opened for question. [Operator Instructions] This conference is being recorded today, May 8, 2020. I'd now like to turn the conference call over to Louise Batchelor, Chief Marketing and Communications Officer. Please go ahead.

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 first quarter of 2020, along with a discussion of 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 is Mr. Cameron Reynolds, President and Chief Executive Officer; Mr. David Vanston, Chief Financial Officer; and Dr. Jake Micallef, 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 report 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, and the ongoing pandemic, speaking to which let me first start by addressing how the COVID-19 pandemic has affected operations for Volition thus far. During the first quarter of 2020, we implemented contingency planning to protect the health and well-being of our employees, with most employees working remotely where possible. Our lab in Belgium has remained open with the attendance of our dedicated laboratory technicians who have kept our research and development work on track with our expectations. Many of our small and medium sized studies have already been collected and their samples stored at our onsite biobank, so the trial work underway and planned for the first half of 2020 is still tracking expectations. Regarding our large-scale studies, both the colorectal cancer and lung cancer studies underway in Taiwan are still ongoing with collection. However the study collection in the U.S. with the EDRN has been paused during the pandemic. The overall timing impact of the EDRN collection pause on the study is unknown at this stage, however, we'll provide an update once the study re-commences. Unsurprisingly, we have taken the decision, given the current travel restrictions, to postpone our Capital Markets Day originally planned for June 1 to later this year, most likely in September, and we will announce a new date as soon as possible. We hope to see many of you in person then. For the quarter ended March 31, we did not observe significant impact on our business operations due to the COVID pandemic. However, going forward to the extent the pandemic continue and worsens, we cannot at this time predict the effects it may have on our company in future. The key potential risks from the pandemic relate to the slowing of the supply chain, our consumables and antibody and the delay in the provision of services by external contractors. We are working hard to mitigate any risks, whilst continuing to protect the health of our team. I'm truly proud of how hard the whole thing has continued to work throughout these difficult times. My thanks to them and their families for quickly adjusting to the situation. Our aim has been to continue to work at full speed to meet upfront milestones. On subject to the COVID after the quarter end in mid-April, we announced that we are actively developing a COVID triage test using our proprietary Nu.Q platform that aims to predict the likelihood that an individual who is COVID positive will develop complications and severe disease. The goal of this test is to provide early insight into which patients may require higher levels of monitoring, including hospitalization and critical care resources, versus those who will not develop serious symptoms. Preliminary studies of patients with COVID infection are ongoing in hospitals in Belgium and Germany. While cancer remains our core focus disease wise, our existing Nu.Q epigenetic toolbox may have the potential to help doctors and patients in the COVID pandemic or in future respiratory viral outbreaks including pneumonia. We have filed a novel patent for the utilization of our Nu.Q epigenetic platform for the triaging of COVID-19 sufferers. This patent is also potentially useful going forward in many other respiratory infections such as the flu and pneumonia given the similarities. I am delighted have today, preliminary results from our first proof-of-concept study in 84 patients, 34 which were -- who were PCR positive for COVID-19 and 50 control subjects, nucleosomes were highly elevated in the PCR positive COVID subject. The Area Under the Curve, AUC, for single Nu.Q assay was 98.7%, PCR positive COVID versus control subjects with 100% sensitivity detection at 94% specificity. A second Nu.Q assay also showed promising results with an AUC of 86.2%. These top line results are top of the press, so to speak, and further analysis of the data will be undertaken. However, I thought it important to share this initial news. I look forward to sharing further results of the trial and indeed other ongoing studies with the goal of developing a clinically useful product to help in the battle against the COVID-19 global pandemic and potentially other diseases. I am delighted that the hard work to develop our Nu.Q platform is starting to pay dividends. For example, for the COVID trials, we could send our Nu.Q assays knowing that they are robust, reproducible and reliable to a third-party labs and hospitals. This yet again shows the amazing potential range of uses of our epigenetics toolbox. As I'm sure you can imagine, our team has worked exceptionally hard to facilitate these studies in such a short-period of time. So thanks once more to all of your efforts. But even given this additional work in the COVID-19 arena, I'm also happy to say that we have kept our momentum on our core focus of cancer diagnostics and have made significant progress this quarter on numerous fronts, particularly in assay and platform developments, and with our Nu.Q capture program. Let me emphasize, we are currently on track with the milestone details in the corporate deck made available on our website last month, with further details provided on this call. Firstly, at the beginning of the year, we completed the acquisition of Octamer to expand our capabilities in epigenetics, and further our goals of bringing all three components of our tests in-house. Secondly, simple multi-well plate format is expected to be seen by the end of this quarter, quarter two. Additionally, with regards to our fully automated magnetic bead-based chemiluminescent format, we have now finalized eight assays by the end of last quarter, which was our target, and studies are now ongoing for colorectal, lung and blood cancer with data read outs expected by the end of this quarter. In addition, I'm also delighted to announce today that we have also recently signed a contract with Shanghai Fosun Long March Medical Science, Fosun Long March China to further develop our Nu.Q magnetic particle-based assays for use on Fosun's open-access platform LUMIART-II, an Automated Chemiluminescence Immunoassay System. The agreement allows for the parties to negotiate an exclusive license agreement for Fosun Long March to distribute Volition's Nu.Q tests for the LUMIART System in China. This is very strong progress on our strategy to begin the process of international commercialization of our assays. I believe that we have made fantastic progress on all fronts, particularly given the challenging circumstances of recent months. Given the strength of our platform, we have also made strong progress on the veterinary front. We are now following the end of the third quarter, our initial data for Nu.Q Vet in a proof-of-concept study conducted by Texas A&M University, one of the world's leading experts at a specificity of 90%, a single Nu.Q Vet assay to take it over 70% of both Canine blood and lymphoma cancers with an Area Under the Curve of 84.5% and 83.1% versus healthy. These two cancers alone represent almost a third of all canine cancers. These results, with the team in Texas open us to move forward with other Nu.Q vet assays in our pipeline and with the larger range of cohorts and trials that we have collected and that are planned. There is a video interview with Associate Professor Heather Wilson-Robles, who also serves as Volition Veterinary's Chief Medical Officer on our website, as well as a presentation deck focused on Volition Vet Diagnostics, so please take a look for more in-depth analysis. It is exciting to see such strong results from our first Nu.Q vet study conducted by Texas A&M University veterinary hospital. It is also interesting to note that the similar patents of detection seen in both canine and human samples confirming that the Nu.Q platform does appear to be useful in more than just human diagnostic. At this human diagnostics, there are currently no active, simple, affordable cancer screening tests available in the vet medicine market and yet 25% of dogs will develop cancer at some stage in their life. Commercially, this is a significant opportunity. The U.S. is currently the largest vet market in the world with almost 70 million pet dogs and approximately 6 million cancers diagnosed each year in dogs, which is about 2.5 times the numbers diagnosed in humans. That's diagnostic have a clearly defined regulatory pathway via the USDA requiring fewer and smaller clinical studies when the FDA process human diagnostics, which generally allows a much faster route to revenue from vet products as compared to human products. I look forward to completing the planned trials and to launch our first Nu.Q Vet product in the U.S. that we expect to occur [ph] this year. Looking ahead, I'm very happy to report that we have had three abstracts accepted for publication, but ASCO, the American Society of Clinical Oncology, one of the world's biggest cancer conferences. Due to their strict rules, I cannot discuss these in detail today, but they are expected to be publicly released after-market close on Wednesday, May 13, but please keep an eye out for these. For those of you who follow up closely, you will be well aware that it has been some time since we published data at conferences. Following the significant work on both the platform development and securing our IP, we expect the abstract publications to be the first of many this year, and are also planning to get a number of clinical papers to publication throughout this year and beyond. We believe that now is the time to publish, and so the validity of our Nu.Q platform in so many areas. In financial terms, we closed out the quarter with approximately $12 million in cash and equivalents. We continue to manage cash carefully and believe that we are in a solid position with regards to the financial runway to achieve our key 2020 milestones. Looking 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 focused on advancing the science of epigenetics and exploiting these advantages in human and animal health. This has been our mission since our founding and it's coming to fruition with our Nu.Q platform at the very heart of epigenetics. So we say the epigenetic is as, if not more important than the DNA genetic. In short, it's not the DNA, it's the full chromosome. 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 expensive 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're making, and I'm excited by the momentum we have developed in this epigenetics field. Indeed the whole team is incredibly excited by the company's future opportunities. We aim to report throughout this year and beyond several key milestones including Nu.Q's ability to detect a range of cancers in both human and animals. In addition to the clinical data of the NU.Q Capture program and data relating to COVID-19 triage test in development. We are delighted to be working with our collaborators from around the world, all of whom have outstanding reputation and share our aim in improving early diagnosis of cancer and other diseases. I along with the rest of the board and indeed the whole company, look forward to sharing the results of key studies over coming months and year, with our optimized platform. We expect 2020 to be our most exciting year yet. Thanks for joining the call today. I very much appreciate it, given the busy earnings call season and the pandemic, we are happy to take your questions now. Operator?

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Mark Breidenbach with Oppenheimer. Please proceed with your question.

Hey, guys. We've got Matt [ph] on here for Mark. Thanks for taking our questions. And Cameron, let me extend my congratulations on the recent progress.

Thank you.

On interesting proof-of-concept data in COVID, and I'm just wondering what you attribute to the high level of specificity. And also whether you believe the Nu.Qs could discriminate COVID from other active infections, which may be increasing nucleosomes in blood presumably?

Yes, very good question. And yes, we were very surprised -- we're pleasantly surprised with the results that came through from this. This was just COVID versus normal controls. That was an exceptionally high result, and we're doing a lot of work now on the prognostic and the diagnostic process. Obviously, a lot of that includes other conditions, which could cause some of the nucleosomes to be raised. We're doing a lot of work on that. Actually it's being run this week and through the next weeks. Our collaborators in Germany and Belgium are very excited with the results that's seen. We're measuring the body's response to the virus, and it's in this case in the nets the NETs, the neutrophil extracellular traps. So we'll see -- all those questions will be answered, but we're just trying to be conservative at the moment. Just we're very excited with what we have. We'll be doing a lot of work reading out in the short to medium term, and we can answer all of those questions, but it was a very good result to start with, and something we will look very carefully at the diagnostic and prognostic value. But I think what's important to notice always in these areas is -- this is a COVID issue, but it's also -- the reaction the body has with the NETs. If it is useful in COVID, it would also be useful in ammonia and the flu, which also have a very raised level of NETs and also kills people through a very similar mechanism. So we can open in this pandemic hopefully and we'll have that information soon. And if it works for that it could work for a long time in the future as well through the other mechanisms. So very exciting, but we will give a full update once we know and that shouldn't be very long.

Okay, great. That makes sense. Yes. So now I guess turning to the clinical grade assays, it sounds like you have eight. Now that has then validated. I'm just wondering whether you think eventually you will probably have to use different combinations of these assays based on the indication whether it's lung or colorectal or other. And then if you could just give us an update when you plan to have finalized panels for the Taiwanese lung trial and the EDRN study? Thanks.

Yes. So we have eight now. That's exactly right. And that's by far the most we've ever had in this stage because we've been doing this now. So we're doing three or four more per quarter. So it's not just eight. We expect to have, again 12 and then 16, by the end of the year. And you're right, so some of them are good in a range of different diseases in cancers, and we would expect some of them to be better or worse in different diseases and different cancers. So that's the process. Of course, the ones we're going for are the ones that have been shown to be differential in the tissue because that's where we found them from. And I think it's also important to know that we're also looking for new biomarkers using the mass spec work in the Nu.Q Capture program. So there is a lot of evidence of different structures in different diseases and different cancers, and we have developed the assays for them and we'll run them through the trials to confirm all of that, and we're also adding through that our new markets, which have not been shown before that we're discovering through Nu.Q Capture and the mass spec work. So, very exciting. So we'll determine the panels, we are running the smaller populations now into colorectal or lung and we will add to that the medium and large populations. So I would expect to have a very good indication of or have the more very good indication this year for lung and colorectal as we get more and more assays. But we've seen some which work extremely well and we're looking to be -- now that they are working well, we don't think we need a panel of five or six that we're hoping a panel of as little as three or four will work. So we're zeroing in on it. We're not there yet, but we will have a lot more data once we can run 8, 10, 12 assays through the populations, all of which we've adapted to the platform because they showed good utility in other things. So we're very hopeful. And don't forget it is not just something which is a good assay, but doesn't correlate with the assays that currently work. You want something that detects differently, otherwise there is no additive. But we're extremely happy with how the development process is going. Eight -- lot of assays we've done in the last few months. Particularly given the pandemic and all the other work, the team in Belgium has done a fantastic job. And it's not just a number of assays which is important and that's gone up a lot, but now it's extremely robust and reproducible, which has allowed us not only to progress the work very well in the London colorectal space, but also do the Vet and the Capture, and now the COVID work because it's all the same platform. So, yes, it's been very good, so we'll -- yes, eight assays, four more each quarter, and we'll have a lot of data coming up in the months and we'd aim to get the panel speak to you soon.

And then maybe just one more if I can squeeze it in. Do you still think you'll be able to have data from the Taiwanese lung trial at some point in the first half of this year? Or do you think given the pandemic that those timelines might shift by [indiscernible]?

I think it's a reasonable target, but if it ships -- if it slips, it is only a few months, we will have data in the short term, short to medium term. We're reasonably on target, I think. It's never exactly sure with everything, but it's -- I'm not unaware it's delayed now, it could be in the future, but it's -- we are sticking to the target. It's coming up and that's for sure. The main delay was getting the assays developed on the platform and now that we have a lot, we should have that data.

Great. Thanks for taking my questions.

Thank you, Matt. Thank you.

Thank you. Our next question comes from Jason McCarthy with Maxim. Please proceed with your question.

Hey, guys. Thanks for taking the question. This is Michael [ph] on for Jason. Sir, I'd like to say -- I have another follow-up question on the COVID test, and really how do you transition this into the triage setting, because based on the data you released, it seems to confirm that you guys can in fact detect nucleosomes being elevated in COVID with high accuracy. But then what do you need to determine in order for it be applied to triaging patients?

Yes, so absolutely correct. So what we showed was COVID versus normal. So that's the first step. If you don't have that, could get anything in the triage. The next step is what we're doing now. We're getting a lot more samples with differential diagnosis and prognosis, those that have proceeded very well, those that have proceeded very badly into ICU, and unfortunately some deaths, and how that relates to competing conditions and other things. So that's all in process now. What the aim is to see. So the body's reaction to the COVID is several fold, you know fever, antibodies, but also NETs which are what we can detect with our assays because it's chromatin based. It's the last line of defense, if you will. The body throws out -- the white cells throw out the NETs to trap the virus physically, which is a good defense mechanism, but like anything if there's too much of it can cause a lot of problems. So, we're getting very high signals in some of the COVID positives. We will do analysis now to see what that's from and if it is from the NETs and we can detect it, which is what we're looking to do. See how early we could have told someone that they're going to be getting into trouble from the coronavirus through the body's immune response, which is what we detect not the virus itself, but the body's response. And in this situation, it is the body's response which actually causes the mortalities with the NETs because it clogs up lungs and some other organs, if there is too much of it. And if you think of it that way, like a fever, the body has fever, and it's good to kill the virus. If it kills the virus, but you can be too much, and you could have too much immune response from the NETs. So we detect take that and we now show we can attack that in the COVID patients. So now what we've got to do is not just have plus or minus, but look through time points to see how early we could tell that someone is going to be in trouble, because it is very -- it's very tough now to really know what that's going to be. So we think through our collaborators, it would be an extremely clinical useful product, if we can show all of that. The first times have been good from this, but we've got more work to do. But given the pandemic, it's a lot of work being done now and a lot of sample has being collected. So it's something which we will have in the short-term to see what the prognostic value is. And because of the robustness of our platform, as we said, we've got very reproducible, very robust assays. It's something if it did become a product, it could happen quite quickly. Things are being improved in very quick time as you know. So we'll say we've been very happy with the results so far, and we're really trying to see if we can help out on the prognostic side and we'll move forward. But I think it's also important to notice that we are -- I mean we're an epigenetics company, but our primary focus is also all the cancer trials we are having in the vet side and the capture, which will be going incredibly well during this pandemic. But, yes, it's very exciting. We'll see how the COVID fight goes and we should have more information soon.

Thank you. And then actually two; just switch over to the Capture program. It seems like there's going to be a lot of data this year, and assuming that that comes and expected for, you know, the sequencing immunoassay mass spec data. Then once you have that, what are the next steps. I know that you're seeking some licensing opportunities for 2021. So could you give us a little bit of color on what those might look like and where this technology is -- where you're looking to position this to be applied?

Yes, that's a good question, Michael. So Capture program, just a quick refresher. We didn't discuss it a lot on this call, because we had say much else going on, but that's progressing very, very well as well. We will have a lot more updates on that soon. But what we can tell you now before the updates, which will be soon, what it does is capture or pull out the nucleosomes preferentially from whatever structure we have the antibody for. So one big use for that is pulling out long from short nucleosomes, which short nucleosomes 147 basepairs have been shown to be much more common in the cancer. So you're looking to enrich with some of the -- with the nucleosomes, enrich the DNA and the nucleosomes from the cancer, that could obviously be very helpful in our assays. If you can clear out some of the background noise, you always get a better result. And we think that could be extremely helpful in the sequencing business because there is such a problem -- they have a lot more problem with background than we do, because the nucleosomes are a lot more common than mutations in the DNA. So it can be extremely helpful we think either in a clean out step before our assays and we're doing that work. We're also doing work on concentrating the DNA and sequencing as you say. If we can show that we can concentrate the nucleosomes in the DNA and that increases the validity of screening, that's a massive licensing opportunity for anyone in this space. And as I mentioned before, once you have the nucleosome, you can also do mass spectrometry which in very simple terms is -- you smash it apart and look exactly what was there. So it's an absolute proof as to what's on the nucleosome. And the mass spec work now can actually look down to the level of the histone modifications and the methylation levels on each histone modifications is quite remarkable. So that's at the moment being used as discovery tool for approving what we're looking for is there, also looking for new markets that have not been shown. So very powerful. And in the future potentially in three, four, five years down the road, it would be a great way to multiplex four or five different targets because there is no -- not specificity issues, if you're actually looking at just the mass spec work. So how does that look; so we're doing the work now to see if it works well as a clear out step in our assays. We will have data on that soon. We're also doing work on the concentration of nucleosomes from known cancers to see if we can increase the concentration of the mutations for sequencing with the aim of making sequencing much quicker and easier for those companies. A lot of sequencing now goes to about 50,000x, we're seeing if we can do with a lot lower coverage, and therefore cost, which could be as I'm sure that would be extremely helpful. So all of the work we've done on the assays has actually helped the Capture program immensely because it's the same antibodies, the same work, it's actually -- and just for background, the actual Capture is as much cost as one assay and it can be done on the machine because what you're doing is you have the antibodies on the magnetic beads, and then you pull that out with a magnet. So it really is still a very simple process. I mean it's taken a lot of work to work out and a lot of optimization is all our new intellectual property which Dr. Micallef who is on the line now has been filing very -- a lot recently as well as all the way through our 10 years. It's extremely exciting. So it can be used in many ways, and will have a lot more information on that this year and soon.

Thank you. And then there is one more from me. It looks like there's going to be a lot of progress in 2020 of that moving forward towards the market commercial prep for three years and a number of studies. So how should we look at expenses going forward? Should we anticipate the higher run rate that we saw in the first quarter continue throughout the year or how should we look at that?

I think for the moment we're actually tracking what -- we are at our long-term target, which is $1.2 million, $1.3 million a month. If you look over the last 12 months, the first quarter is always higher, because we have D&O, and it's a lot of annual expenses that come out early in the year, and this quarter we also had the Octamer purchase, which is obviously a one-off. So we may end up doing more work, but at the moment we are tracking a 12-month average. It is definitely lumpy between quarters for those reasons, but I don't think it's going to be raising a lot. And if it is, we'll update it next quarter. But certainly for these summer months until the next quarter, until we update, I think we're looking to track our long-term average.

All right. Thank you very much, Cameron. I'm looking forward to the progress. Stay safe guys.

Thank you, Michael. Yes, it's exciting times.

Thank you. Our next question comes from Bruce Jackson with Benchmark Company. Please proceed with your question.

Hi, good morning and thank you for taking my questions.

Thank you, Bruce.

So if we could just talk for a moment about the veterinary program, you brought out the proof-of-concept data. What work remains to be done with that program. Do you still think it's going to be the first product out the door? Is the commercialization strategy still going to be possibly so lab developed test? And then if you could also maybe as a follow-up run through the rank order of the pipeline in terms of how they might be launched?

Yes. Thanks, Bruce. Good questions. And Vet is a very important part of what we do and make sure it doesn't get lost in all the other news. So yes, the proof-of-concept data was very, very encouraging, and those cancers were picked by the Texas A&M Vet team because they're very important and it's about a third of all dog cancers. So it was extremely good to see those results. And it actually mirrors what we know from those cancers in humans. So all in all, it's a really good validation of what we do by an independent group, and it's what we've been working for with robust reliable assays. We shipped in the assays and we were working with great partners. You know what questions are needed in the vet clinic, obviously we don't and they do. So it's been a really good network and marriage of our two abilities. So, yes, so we've had the point of contact -- point of care data, and that was on the plates. The plates we would ship to them, that was the most simple format, as you know. They currently have an idea [indiscernible] our magnetic bead platform, which will be operational soon, and then they can run up. We only have a few assays now on plates which is why running [ph] down a few. We have, as you heard, eight now on the plates and on the magnetic beads, and we're going to have a lot more soon. So that would be running a lot of assays through a lot more samples to have a lot more stored up, and for other cancers and trying to get bigger patents rather, I mean it was quite remarkable results just for those single assays and that's what we had on the plates, but we have a very wide range now. And interestingly, we are also going to be doing the same work we did in humans on the Capture side from the animal side, just to give us a lot more information, see how just for validation and also for the potential vet market, so that will be coming through this year as well. And then the launches, yes, you're correct. The first test, we aim to be is a lab developed test. It's like a CLIA lab. It's not humans, but they have their own lab there which we visited in Texas, and there are hospitals. So that's the logical place to launch the test and they can do that -- as soon as they're comfortable, they can launch it in their own lab because they're obviously specialists and is there a lab, they can do like a CLIA lab. And then we look to do a USDA product for the cancers which worked very well to launch sort of a kits product that can be truly shipped around. So it's tracking very well. It's again eerily similar to what we've seen in humans, both in the pre-analytics and how the assays perform. And I think we're starting to learn a lot both ways. You noticed the blood cancer was the one which worked extremely well, one of the two that worked extremely well on the vet side, and because of that we started looking in humans in the blood cancers, and it showed up incredibly well as well. So, I think you will see a lot of cross-pollination not just going to the vet side, but also starting to come back. And it's -- the rising tide is lifting all boats because I think we spent the time really getting the platform absolutely robust reproducible. It was a lot of work in the last two-and-a-half years and it's -- there's been a lot of sweat from the team in Belgium, particularly, but it's really showing that we can really do a lot of different things. So, yes, we'll see a lot more data and Texas will start publishing quite aggressively, like the rest of the company because we've got a lot to say. And we're very, very happy with the platform and our intellectual property in the vet space as well as the human. So there'll be a lot happening in the vet space.

And then, after we get the vet tests launched in the human -- on the human side, which assay do you think is going to be the first one to reach the market?

So the human side, well, we say, if we do find something clinically useful in the COVID, it would pretty certainly be that because the approval process is really shortened because of the pandemic, but again that's unknown, but we will know I think in the short to medium term. If not, I think the most likely one is the triage, which will be [indiscernible] on schedule for the end of next month, and we're running it through some triage trials. So far is the lung and colorectal, it is tough to tell, we're running medium to big trials in both of those. We'll see what's the clinical use and what's the panel, which comes out from those, but we're doing a lot of work in both of those as well. And also I think the highest results we have regarding detection is actually been the blood cancers, which we had data on which has also been good. So we're now working through what's the clinical question that's best answered and the trials for that. So the short answer is, if we can find something clinically useful from COVID, it's likely to be the first because the assays are ready and it's a very short approval process, given the nature of the pandemic. Second to that, would be the triage. And on top of all that, we'd have the vet side. And I think we haven't done a lot of work on the research kits in the last few months, we've been so busy with everything else. But I think as we start to aggressively published, I wouldn't be surprised if that really saw pick up as well. I think there's a huge push now in the epigenetic space and we really are at the heart of it and I think we could -- we've shown really good efficacy now in cancer, in humans and dogs. We've shown utility potentially very strongly in COVID. Collaborators are doing work in pregnancy and pre-eclampsia and lung diseases and other things. It's truly showing epigenetics to be incredibly important in a lot of different things. So there'll be a lot to talk about over the next 12 months.

Absolutely. Getting back to the COVID-19 data that you showed this morning with the proof-of-concept data, was that the NETs assay that you were referring to or was it another one? And then you said there were two Nu.Q assays that were being evaluated. So...

Yes, we're publishing and we're also patenting. So I mentioned which two assays they were, but yes, I worked incredibly well in this aspect, and the other one, I mean 86 is still incredibly good as you see, and they do different things. So we've got a lot of work to do. Our collaborators are working at a lot of other markets as well for these same purposes in clicking trials. The same combination [indiscernible] work the different questions, prognostic as well as diagnostic. The PCR is a great test as you know. It is very accurate, but it has its issues. So they're working to see how it can work in a lot of different ways. There is a lot of clinical questions now being thrown up because of COVID beyond just the straight diagnostic question, and it appears very much that the NETs are a very big part of what does the damage to your body. And obviously the NETs very much related to chromatin, I mean it is chromatin that is spewed out. So that's what our assays appear. It's all cutting edge now. So we'll publish that. I think there'll be a lot of papers published in the future on how our assays and can be determining all the NETs in the process, but we are working right now and we'll update a lot in the short-term.

Okay, great. Thank you very much.

Thank you.

Thank you. Our next question comes from Jason Kolbert with Dawson James. Please proceed with your question.

Hi, guys. Thank you. Pretty good run down. But I just want to pick up on some of the questions that have already been asked. When you talk about the COVID assay and detecting the NETs, my understanding of what you're saying is that you can detect what the body's immune response might be and it might be a predictor of who's going to get into a cytokine storm that's going to result in potentially candidates for ventilators. And so it could be used as a prognostic to determine where there would be benefit for a viral knock down like remdesivir. And if that interpretation is correct, I'm wondering whether there is discussions going on with therapeutic developers, so that they could use the assay prognostically to determine which candidates would be best for therapy and what the timing of that therapeutic intervention might be?

I'll give a quick answer, and then if Jake has anything more to add he can as our Chief Scientist. We're doing a lot of research and I can't talk about too much of it now because obviously we are -- some of it's confidential to make it public in the process, but there's a lot going on. And I think we could be very helpful in the areas you mentioned, but we will -- anything that we actually finalize will announce once it's completed. Jake, do you have any more to say on them.

Only that the work is ongoing. And if the assays do indeed turn out to be prognostic, then they could very well be used in the scenario that you described, where we're not really at a stage where we can say that yet.

Okay. But that -- I mean, that's the true differentiator, right, because there are a lot of good assays that will determine COVID presence, but there are very few assays that can determine magnitude and/or predict kind of the response, because that's the whole game, right. There are a lot of people who will get COVID and have no symptoms, and there are other people that get into real trouble. So being able to delineate those two to me seems like you have an incredibly differentiated product if that turns out to be the case. Is that how you're looking at it too?

That's exactly how we're looking at it. Yes.

Exactly, right, yes. But I think with the nature and the size of potential is...

I was going to say that what we're measuring although we get superb detection for COVID that's not actually our goal at all. And what we are measuring, as Cameron was saying is not the COVID itself, but the body's response to the COVID, and it is an over response and one aspect of that is the cytokine's ghost [ph] storm that is the cause of the complications and it is that that we're measuring. And so, we're very successfully measuring that. And whether that is clinically useful in the way that you describe is something that we're investigating now.

Yes. I mean, we all under -- the implication for that are huge. So have you had any early discussions or any contact with people on the COVID task force or [indiscernible] or BARDA, I assume those channels are open to you.

Yes, we have been very active. We've been looking at this for several months. And given the size of the opportunity and how much we can help, we're just trying to be conservative until we are certain exactly what we can do, but all the things you described is exactly what we've look to do. And we've been in communication with the authorities as you mentioned in the U.S., as well as in Europe, as well as in Asia because if you can have a prognostic it's incredibly useful. And as you said, there is really nothing out there currently in this space. And as Jake has mentioned before, it's also potentially very useful in pneumonia and in the flu which caused millions of hospitalizations every year as well going forward; [indiscernible].

Right. With the same kind of cytokine storm associated with it, I think.

Exactly. Exactly, yes.

Thank you. That's really exciting. And on the veterinary side, and this is also on the human side, the ability to determine kind of the source of the cancer, help me understand on the veterinary side, what the sequence of events are? Patient brings in their dog and the veterinarian either determines there is a GI-related or other-related tumor, but they may not know, unlike a human right the dogs don't talk. So the ability to who isolate back, what type of cancer it is, how far advanced is the diagnostic library that will allow you to kind of link those to? So what I'm -- the question I'm really asking is beyond detection, it's source and library matching right. Now, of course that has huge implications, not just for canines, but in ethical diagnostics too, and I just want to make sure I understand that connection.

So just a quick answer to that, and I think it's probably good to hook you up with our vet team because they -- no one on this call is a vet expert, and that's why we work with Texas A&M because they understand the clinic very well and the processes. So, we're relied on them very heavily to tell us what clinical questions, what are the different cancers and what the clinical process would be for each of the -- and it is different from the vet hospitals to a vet lab to single vet hospitals, and they're working on that a lot. As for the epigenetics in the human space, Jake can go through that with you, but it's -- as we talked about a lot, there are a lot of epigenetic structures on the nucleosome, hundreds and hundreds and hundreds. There is lot been shown to be different in different diseases and different cancers and then tissue, which is what we've been following, and now we're looking at our own markets through domestic commentary. But we thought the process we've gone through is that -- that works all being done by others on what targets to look for on the tissue. We've been really optimizing our platform to make sure we can measure all of those, which is what we've done and just coming through now. And now were going to be using a lot of those assays to try to get the differences between the different cancers as well as just detecting the cancer themselves. And we've seen some differences. There's a lot of similarities with some assays between the cancers, which makes sense. And there's a lot of -- we're looking now for assays in our growing library, which are differential between the cancers, which are definitely others. So we've got to work to work out a good panel to detect that cancer and also something which differentiates from other cancers and other competing conditions, which is also very important, of course, and that's the work which is ongoing now which is why we'd like to have a lot of assays, so that we can really try to differentiate as well as just discriminate.

Right. So, and the mass spec is really just an internal tool that helps you build the library, so that going forward on a volume basis that just becomes a digital comparison if you will. Is that correct?

Jake, do you want to answer that?

Yes. Domestic really has two uses. One is that we can look far and wide for which markets really are different on the nucleosomes in different cancers as opposed to looking in what other people have found in the literature in tissue. We can really investigate what's different in the blood as you say a discovery tool. And the second possibility, and at this stage, it's very, very early, but in the future, it could in itself become a diagnostic tool where instead of looking at the panel of three or four nucleosomes, and to see where that panel is characteristic of lung cancer or colorectal cancer and so on, we could conceivably be looking at a panel of dozens or even hundreds. And at this point in time, it's far too early to say that that we can or would do such a thing, but in principle that's possible and it's all covered by our intellectual property.

Well, I'm just thinking in terms of throughput, right. It's hard to have throughput when you involve a mass spec. So I'm just for now, what I'm doing is I'm compartmentalizing the mass spec as kind of the internal research tool to help build a library.

[Indiscernible] but also confirms markets that we say there from the antibodies and the recombinant controls are also definitely there. So it's a confirmatory as well as exploratory. But yes, for the next foreseeable future, that's absolutely correct.

Okay. And just I want to close, and I know Michael Okunewitch mentioned this, but I just wanted to make sure I have a handle on the timelines for Nu.Q. There is so much going on, but if I -- if what I understand you're saying is that we should be looking for more incremental data throughout the rest of the year, triage next London, the colorectal study and then some of the hematological assays towards the end of the year, is that right?

Yes. And if you look at the presentation we have, on Slide 6 and 7, there is all the targets for all the different areas from the assays, the trials, the vet and the Capture. There's two pages of them just to be accurate; if you want to refer that that we've kept that up to date.

Really, really professional breakdown. Thank you very much. I'm excited to see as the platform and the company matures, particularly given COVID. I mean this really has the potential to kind of in the words of our President, be a game changer. So it is exciting. Thanks.

Thank you very much. We are excited too.

Thank you. Our next question comes from Nathan Weinstein with Aegis Capital. Please proceed with your question.

Good morning, guys, and thanks for taking my question. So if perhaps you can just remind us about the Octamer acquisition that you closed early in the quarter? And what was exciting to you guys about that and then has integration turned out as expected?

Actually, it's funny. We planned this obviously in the last few quarters of last year. We got to know Dr. Schomburg quite well from our Science Advisory Board, and part of having a very robust platform was having a very good control which is the recombinant nucleosomes, and there are very few people in the world who can make them well. It's very cutting edge and very new, but it's a really key part of the level of robustness that we currently have. So, we've thought about this a lot and we want to control our entire supply chain, which given what's happened since then, it certainly wasn't what we predicted, but it's been very helpful to be having the key components that we have under our control. So the main purpose of it all was to inherit that company's ability to make recombinant nucleosomes which is the control in all the things we do, in the vet assays, in the human assays, in the Capture program and everything and the antibodies. So optimum age that makes excellent nucleosomes, and we've been consuming them. So part of licensing, we're doing our own products obviously, with a big part of what we want to do going forward is licensing because there is no way if epigenetics is a tenth as widespread as it seems to be to us, it is applicability. We're not going to be out to do at all as a small company or even medium company. So we will start licensing. And we've always had the vision to license, but if we can license where we grant the rights to use our intellectual property, which we have a huge amount of now, but also provide the consumables, the nucleosomes and the antibodies. We can keep a good track of how much someone is using and therefore how much product they are making, and also stop copies from coming around, because we can tag the antibodies and the nucleosomes. So it was a very good strategy and our antibodies had actually come to -- sorry, nucleosomes had come through Shanghai which would have been tough obviously in early days of the pandemic, if that would have shut down. So it was actually very lucky. We did that, when we did. It's been a very good process. We have not been aggressively marketing them during the pandemic, mainly because we've been very busy making a lot of nucleosomes for ourselves obviously in all these programs. We've been wanting to do the integration, so we can understand how to make the nucleosomes and really develop them ourselves beyond the team in Munich doing it. We're looking to bring as much of that back into our headquarters in Belgium; so that's going to pace. And we will switch from the integration and making things for ourselves to start actively marketing the nucleosomes because the ones [indiscernible] now are very good and we are learning to mass produce them and mass producing them and tagging them means you bring the cost down a lot and it also means you can control the supply chain and also control what you give to other people in licensing. So a very key aspect of what we do and we are thinking big that this could become a very big piece of the epigenetics market. So we're trying to make sure we've thought of all the things that we need to do and this is a key part of it.

Thank you. And then, perhaps just one more from me. If we think about the supply chain that leads to your assay, just any disruption there from COVID, and just in good times does that tend to be a lot of vendors and easy to get the supply that you need?

So the fantastic thing with our process unlike sequencing and all the other things circulating tumor cells, it's actually, I mean, it's been a lot of work, but it's a very simple in its heart. It's the antibodies and the nucleosomes controls on magnetic beads, which are made by dozens of companies. So, we aim to be manufacturing in our facility the key components for when we start producing products and licensing ourselves. There are some supply chain issues because obviously we're looking at dozens and dozens and dozens of nucleosome targets. So we don't manufacture our nucleosome in it until we've got some utility and develop our own antibody. So we have been -- we still buy some antibodies, we still buy range of things from different groups. So as I said, there have been some of those that have been held up a bit. We've typically as part of what we do try to find at least two or three suppliers for all key components, so that we're not clogged up. But there have been some disruptions. So the things have been coming slower and there has been like with everyone in this crisis, but it hasn't had a major impact on operations because we're doing a lot more ourselves, and we've tried to have a few different suppliers. And eventually things do -- it has been a bit slower during this crisis but suppliers do tend to supply even if there is a bit light. So we would be trying to think ahead and order larger amounts in the areas we're not producing ourselves.

Cameron, thanks so much.

Thank you. Thanks, Nathan.

Thank you. [Operator Instructions] Our next question comes from the line of Anita Dushyanth -- excuse me Dushyanth with Zacks Investment Research. Please proceed with your question.

Hi, good morning. Congratulations on the progress. I just have a couple of questions also on the COVID in the veterinary space. Just to have a better understanding of how the COVID product would go through the regulatory pad, could you discuss the next steps, and what you're doing there? And also considering this pandemic could subside temporarily and there is a talk that there is a possibility of recurrence maybe couple of times later in the season. How do you sort of expect to rollout this into the market, maybe there is some lumpiness in certain quarters, and then it's kind of the later?

Yes, absolutely. So the next steps, we're doing a lot more clinical work. So the assays as we've seen discriminate extremely well between COVID and normal patients. Now we're going through several samples from the same people to see what the outcome was and how early we could predict that outcomes obviously. And we have some very good clinical partners who have collected samples for this for a lot of different questions, I mean, including that. So well, the next step is to see where the discrimination we found could be useful along the lines that we've talked about. So that's all in process, and they're collecting a lot. And now that we have had very good proof-of-concept data, they're getting keener and keener obviously because as Jason mentioned earlier, it's potentially a massive use to the clinic if we can show what we're looking to show. So, that have been extremely helpful and quick in getting us samples and running. So these are not being run ourselves. We don't run an infectious lab. So we cannot -- we don't have the protection for our staff to be running them. So these are all being run in the hospitals where the COVID is being treated and detected, so we've been shipping them kits. So again, it shows the robustness of what we do, the fact that we can ship kits and they can run them. It's otherwise would be very difficult to have done it ourselves, because we don't run a lab that can run infectious samples. So the next steps to see the value in all the things we're looking at, if we can find something that is useful, we will look to launch a product in the clinic in Europe that will meet a CE mark, which are getting approved quite quickly now that depends again what platform we use. We have the very simple platform format, which has its uses and we also have the magnetic beads, which can be adapted to many platforms, including one of the ones which we have in Europe and the one we are working with Fosun on in China. And that will become obvious once we know if there is a good clinical utility. And then, yes, there are -- I mean the COVID does have the potential to wax and wane for the foreseeable future until there is a vaccine. So we'll see how that goes. But also, don't forget the same NETs mechanism is very common to a lot of other diseases which are very common in normal times pneumonia and influenza outbreaks. So I think if we can show clinical utility, there could well be a strong utility going forward. There are millions and millions of people hospitalized every year from those as well. So, I think it's the same platform; it's the same assays that we're seeing, where we can help. But I think that will all become obvious once we see what the clinical utility is and we can give a good timeline and plan for all that once we know, but we are very actively working on it.

Great, that was helpful. Thank you. And regarding the veterinary space, does the hemangiosarcoma and the lymphoma, are they specific to certain breeds in the canines and are you also looking at the detection in other animals?

Yes. So dog cancers are a little different from human so far as -- because the inter-breeding, I guess particularly you have types of dogs of varying breed so much more prone to specific cancers. So yes, I will go through the breeds, because that's a vet question, but there, I'm very specific; so a lot of cancers in a lot of different breeds of dogs. It's very common to get one particular type of cancer. Often, over half the cancers in a particular breed are one particular cancer because of the inbreeding. So it's something which is actually quite breed specific which is actually very helpful because then you if you know we have cancer at a certain breed, you can have a very good guess at what sort of cancer it is. And that's again issues which the reason we've used vet schools to double this work has obviously been very specific knowledge there, which is not in -- currently in Volition, but very much in Volition veterinary in Texas. So they targeted cancers, which very common in the breeds they see a lot and very common in dogs overall, so that it could be very clinically useful. And that's why they chose the cancers which we looked at. And it is extremely encouraging to see business combination that we did so early in the program. This is really the first shot at it and it was very encouraging. As far as other animals go, anything with DNA has this very similar nucleosomes. So we've had preliminary discussions on a range of other animals, but we thought the Nu.Q vet process. Let's go through dogs, launched the first production and then we look at the other animals. But the most obvious ones are kept obviously. Because obviously, some agricultural is logical uses as well, but that's really a next year story, while we get dogs through the process. And then at the other item was on. But there is -- if we launch successful products in the dog space, there is no reason to think we couldn't do it in a wide range of other animals because they will have the same problems, they will get cancer and they will have the same nucleosomes. So it's something, which has a potential very large values for all those areas, but that's something we'd really start to look to license out even from the vet subsidiary, because there's a lot of work in all of those things, but it would be the same platform. So it could be done very quickly with groups that are very specialist in those other animals and that will all be in the process in the future.

And I presume that you're possibly after launching this by the end of the year you're looking at other cancers in dogs or so?

That's correct. They've collected in Texas, a range of different cancers in different dogs. And so the process forward is not just more assays in these cancers, which obviously would be helpful. It's good. If you can have a panel of two or three, which is even better than these then obviously it's -- each assay doesn't cost a lot or take a lot of blood. So you add more assays if you can get better discrimination. So they're in the process of doing that and also the process of looking at other cancers, and we expect some data on that in the short to medium term. And then do bigger trials and launch products in those as you get them. Yes, it's very important to remember how common cancer risen in dogs and how dire the current situation is in detection of cancer in dogs because as Jason mentioned earlier, it's very tough to ask a broad questions. It is very tough to scan an animal because they move, they won't stay still obviously, and human proteins don't work, you know the most for obvious reasons. So it's an even more dire situation in diagnostics of animals than in humans. So, potentially a very, very big opportunity and one that we're very happy with the partnership we have with Texas A&M, because they really know what they're doing in the vet space, and we're providing the assays and the know-how from the epigenetics side, and they are providing the veterinary knowledge. So it's a very good union.

Yes. Yes, thank you. And lastly, regarding the cancer studies that are going on in human population, so geographically also the population is exposed to different types of cancers. So do you plan to sort of license and partner in different regions.

Yes, absolutely. So, very good question. So we want to become experts in epigenetics and the assays and intellectual property. We're launching our own products because we think we can do that with what we have and the trials we're collecting. But I think that's going to be -- the epigenetic space is going to be far too big for one company to launch products in all those areas. As I mentioned, all the different cancers as a lot of other diseases are showing a lot of big epigenetic component, even COVID which is a virus because of immune response. So I think this can be very, very important in a lot of areas. So the first revenue will come from our own products. And -- but I think we aim to layer in more and more licensing and key to that is keeping control of the key components ourselves which we can sell and also keep control of to really ascertain, what's the volume of sales from the licensees. So, we're building a roll up for our first products but also to be very aggressively licensing. And I think the licensing will become a bigger and bigger and bigger share of what we do as it becomes say widely applicable in a lot of areas as we expect. And so will aim to launch the first few products and then really aggressively license.

Great, thank you. Thank you for that.

Thank you.

That's all from me. And good luck on the releasing data.

Thank you. Hopefully, we can be helpful in a lot of areas. Thank you, Anita.

Thank you. We have no additional questions at this time. So I'd like to pass the floor back over to management for any additional concluding comments.

Thank you very much for coming on the call today. I know it's a difficult time for everybody. And we really appreciate your interest at this very difficult pandemic time. And I really look forward to all the milestones for the rest -- for the next few months and the few quarters. And I look forward to speaking to you on the next earnings call. Thank you.

Ladies and gentlemen, this does conclude today's teleconference. Once again, we thank you for your participation. And you may disconnect your lines at this time.