VolitionRx Limited (VNRX) Q4 2019 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the VolitionRx Limited's Full Year 2019 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, February 21, 2020. I'd now like to turn the conference call over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you, and welcome everyone to today's earnings conference call for VolitionRx Limited. This call will cover VolitionRx's financial and operating results for the fourth quarter and full year 2019 along with a discussion of our recent activities and key upcoming 2020 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, and Mr. David Benston, Chief Financial 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 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 VolitionRx call today. I especially appreciate that given the busy earnings call season. Let me first start by saying how extremely excited it is to see our field of epigenetics become so mainstream over the past year, which has always been our hope. We have been working for a decade now to develop our epigenetics platform, intellectual property, team and products and so to see this all come together at a time when epigenetics has become so widely accepted one could even say hot is incredibly gratifying and shows the amazing vision of our scientific team. To every one of our team members, I am in owe of your fortitude and grateful for your perseverance particularly given the fact that cutting-edge innovation is really a straight line. I'm happy to say that we have great momentum and have made significant progress on many fronts over the past 12 -months, particularly in assay and platform development with our Nu.Q capture program, our colorectal cancer and lung work, Nu.Q Vet in collaboration with Texas A&M University and most recently with the acquisition of Octamer to expand our capabilities in epigenetics and further our goal of bringing all three components of our test in house. Firstly though given this is our 2019 full-year earnings call; let me start with the financials. We close out 2019 with $17 million in cash and cash equivalents versus $13.4 million at the end of 2018. We continue to enjoy exceptional shareholder support throughout the year receiving $16.6 million in cash proceeds upon the exercise of warrants by existing shareholders. We also further strengthen our balance sheets with additional non-dilutive funding driving $3.3 million from New York stock program and various governmental agencies, taking our total non-delivery funding to date towards $7.6 million. We are really proud to be able to have done all of our work with a consistent and remarkably low monthly cash burn rate of approximately $1.3 million a month throughout 2019. We continue to manage cash very carefully and believe that we are in a solid position with regards to financial runway to achieve our key 2020 milestone. During 2019 and into 2020, our organization grew significantly. Our laboratory team expanded appreciably to include, among others, the appointment of an Assay Validation Expert who has been instrumental in taking our assays forward. We have also added two new operating subsidiaries with the formation of Volition Veterinary Diagnostics in June of last year and the acquisition of our epigenetics reagents subsidiary, Octamer in the early part of 2020. In connection with the formation of Volition Veterinary Diagnostics, we welcomed Nathan Dewsbury as its Chief Executive Officer and through our collaboration with Texas A&M University, Dr. Heather Wilson-Robles to the Nu.Q Vet team as its Chief Medical Officer. In connection with the acquisition of Octamer, we expanded our Scientific Advisory Board to include Dr. Adrian Schomburg, one of the world's leading experts on Nucleosomes and founder and CEO of Octamer. We also welcomed Dr. Phillip Barnes to our Board of Directors. I'm delighted that throughout 2019 and indeed in to early part of this year, we have been able to convert memorandums of understanding into executed contract with price and low math in relation to our first studies in China. Also with the National Taiwan University conduct our first large scale lung cancer study, and with Texas A&M University to collaborate on the development of our Nu.Q Vet products, and most recently, with the completion of our acquisition of the Reagents company, and recovered a nucleus m expert Octamer, which represents the company's first acquisition. I'd like to thank the team for all their hard work in developing relationships with these people and writers and executing on the above transaction. And I'm delighted with all the work underway. And so through our research, development progress, we have completely re-engineered on Nu.Q clinical assay in all six key areas. I will outline shortly. This has led to a step change improvement in analytical performance and, as importantly, made our asset very robust and reproducible, so that they can be adapted to a broad range of platforms in almost any lab in the world. We expect this enhanced analytical performance to translate into improved Clinical performance in the studies be carried out and reported in coming month. Relative to our Elisa plate Nu.Q assay format. The recently developed magnetic particle based assay format demonstrate a 10 to 20 fold improvement in the analytical sensitivity of assay typical within the reproducibility of quantitative test results below 3% previously below 10% decrease in test result turnaround time from six hours to approximately one hour and 20 minutes, allowing much higher throughput, which is crucial for it to be truly a routine tests. The ability to be developed and process on fully automated random access platforms, which enables the use of a wide range of the commercial automated platforms. I'm incredibly proud of the effort the whole team has made in the assay development program over the past two years. We are now very close to finalizing our blood plasma samples pre analytic with these assays and now excited to utilize these automated magnetic chemiluminescence assay in our clinical studies, and aim to start reporting data during the current quarter and throughout 2020. We have continued to create assets in the six key areas referenced earlier, developing recombinant nucleosomes as caliburn, which provides for assay specificity, and reliable quantization. We previously developed synthetic nucleosomes with our partners that have now brought this expertise in house with the recent acquisition of Octamer in January of this year. Also by internalizing key processes such as chemiluminescence antibody labeling, and coating of magnetic b. This secures our supply chain and provides flexibility to speed up or assay development work. Next by moving from a micro tighter plate format to magnetic particles based assay format, this improved assay kinetic and hence assay sensitivity and reduces assay time and increases assay throughput. Moving from a traditional colorimetric endpoint format to Akemi luminescent endpoint. This further reduces background noise, leading to additional improvements in assay sensitivity, as well as greatly extending the usual range of the assays. Moreover, the combination of a chemiluminescence endpoint with a magnetic type assay format greatly improves the specificity of our assays. Finally, moving all these improvements on to an FDA approved automated immuno assay analyzer, which is currently in clinical use across the United States and Europe. This further decreases assay processing time and greatly increases the reproducibility and reliability of as a result. So does the same correct result is produced from any patient sample, regardless of where or when the test is done, or who operates the instrument. And maybe from blood serum to blood plasma as a test sample, which also reduces assay interference. In terms of the all-important clinical accuracy over the past 12 months, as we have been working on the aforementioned assay development, we have completed some proof of concept studies to assess clinical performance. While this work is yet to be completed for the finalized assay, preliminary results were extremely encouraging that for even the development essays, we saw a hot ever area under the curve performance in blood cancer at 91% and in lung cancer at 85%. In addition to reporting positive data in colorectal cancer, as of today, we have four finalized bead based Nu.Q assay and anticipate the further four we've finalized by the end of this quarter. We're excited to then report the clinical performance as both individual assays and in the panel combinations across the range of cancers and expect to release news in the second quarter of 2020 and beyond. By the end of the second quarter of 2020, we also plan to obtain C Mark on the traditional plate format of one of our Nu.Q assays. We believe this will be useful around three hours product. With regard to our large scale clinical studies, collection is well underway in a national town university studies, with over 5,500 samples collected in the colorectal cancer study, and almost a third of the targeted samples already collected in the MTU lung study. In the US, we have currently agreed with the early detection research network of the National Cancer Institute to amend our previous agreement for the gleaned 10 colorectal cancer screening trial. The recent decrease in the incidence of new colorectal cases reduces the number of available qualified subjects for gleaned 10 and we utilize the completion of our study. To address this, DDRN is combining subjects accrued in gleaned 10 with subjects previously collected study glean 7, and has reactivated glean 7 to prospectively collect approximately 400 new colorectal cancer cases under a newly designed the protocol. The aim of the new study design is to collect large cohorts allowing validation of biomarkers for the early detection of colorectal cancer. Our financial contributions to the previous glean 10 studies, which has already been tied by the company will fully satisfied the company's financial obligations for the ongoing glean 7 studies without further payments. The changes to the DDRN studies should not affect our FDA approval strategy, as we still plan to use the study to support our PMA application for colorectal cancer screening product. On the Veterinary side of the business, I'm absolutely delighted with the rapid progress that our team is making. At Texas A&M University, we are now in the process of securing the same machines and automate as we use an absolutely in Belgium, so that the same work can be concurrently carried out on humans and animals at separate locations. This will likely help broaden our knowledge in both human and animal diagnostics, as the work today is proving very similar, associate professor Dr. Heather Wilson with the Texas A&M College of Veterinary medicine, who also work as Chief Medical Officer Evolution Veterinary diagnostics. We are thrilled to formally welcome Heather to the team. It is hard to believe that we only signed the contract with Texas A&M in October of last year. And so much progress has already been made. The preclinical work is almost completed and our first two clinical studies are underway. We plan to get the news out quickly and have a busy conference calendar with a number of abstracts submitted and old presentations already confirmed at some prestigious conferences throughout 2020. So watch this space. I appreciate I've said this on previous calls. But we believe that the Veterinary market presents a significant commercial opportunity for Volition and it creates very little by way of additional costs, given the fact that utilizes the same intellectual property with same assay, the same formats et cetera as we use in our other market. I truly hope that we'll be able to launch our first Nu.Q Vet products during this year. As announced earlier this week, our many years of research in epigenetics have now led to the development of multiple new novel epigenetic tools in our Nu.Q Capture program. For it is only in cancer diagnostics, but hopefully in other areas to. Our team could not be more excited by the potential of these newly developed tools that they believe will lead to a significant shift in epigenetic based blood test. We aim to leverage our technologies to establish a leadership position in epigenetics. We have developed and filed patent applications on our novel Nu.Q Capture based epigenetic tools, in addition to our base Nu.Q assay format to decide for the epigenetic and environmental profiles of cancer nucleosomes with the aim of using this platform in several key areas. Firstly, Nu.Q Capture methods to enrich cancer nucleosomes and simplify sequence based liquid biopsies. Secondly, use our Nu.Q Capture method to isolate and attack nucleosomes from plasma mass spectrometry analysis in the framework of both biomarker discovery and clinical diagnostic. Thirdly, by using our Nu.Q Capture technology to measure global methylation patterns in a simple format, fourthly, use our Nu.Q Capture technology to concentrate nuclear thermal markets prior to our Nu.Q assays with the aim of increasing accuracy. And finally, using our Nu.Q platform to detect and measure circulating nucleosomes and transcription factors, with the potential to be tissue specific, and therefore cancer specific, this if successful, could result in a simple blood test for multiple cancers. This is very exciting. Volition is using these tools to expand diagnostic developments that focus on circulating DNA fragments analysis to a broader and potentially more powerful investigation of the epigenetic status of a patient circulating chromosome fragment. In addition to our ongoing work with this assay base format in a range of cancer. We expect to announce patient data demonstrating the wide utility of these new methods in the coming months and beyond, and are looking forward to abstract, posters and papers to be published as well. Overall, our research and development team has made remarkable progress, while still keeping our cash burn rates low and consistent with prior quarters. I would like to thank our entire team for their tireless efforts. On the intellectual property front, a worldwide portfolio of granted patents that protect various aspects of Volition Nu.Q technology is growing steadily. We believe this is another key differentiator with the many other technologies under the development or available in the market. We have 23 patent families related to our diagnostic test, with a total of 44 patents granted, including eight in United States, nine in Europe and a further 27 worldwide. Additionally, we have 105 patent applications pending including 13 in the U.S., 10 in Europe, and further 82 worldwide. Our patent portfolio also covers veterinary medicine applications. We intend to continue our work in the field of epigenetics through the development of our proprietary Neucleosomics [ph] technology, and will continue to apply for patents for future product development. Our strategy is to protect the technologies and gain market exclusivity with patents in Europe and the United States and in other strategic countries. We believe that the patents on the technology underlying our products should provide broad coverage for each product, including protection through at least 2031. And so, I will now cover the recent past and future plans. We announced in December of last year our intention to acquire epigenetic reagent company Octamer, and we're delighted to quickly close the transaction in early January. This very strategic acquisition helps secure the supply of one of the key components of our Nu.Q test through accommodated nucleosomes use as the calibrant in addition to other know-how and expertise. Since the signing of this agreement just last month, members of our Belgian R&D team have already commenced their training with Dr. Adrian Schomburg and his team at Octamer in Munich, and we're already developing the capability to manufacture recombinant nucleosomes ourselves. We believe that this work will further our goals of becoming one of the world's leading epigenetic companies. In addition to nucleosomes, we plan to manufacture and sell histones, optimas and DNA templates to third parties. These reagents can be used for custom applications in epigenetic research and drug discovery, and help drive early revenue for the company. We also plan to expand our service offerings to run samples with our owned service of our Belgium later this year. Looking ahead to the future, I would like to reiterate our vision and what makes us so excited with the progress in our space. Volition is an epigenetic company focused on advancing the science of epigenetic and exporting these advances in human health. This has been our mission since our founding. And it's come to fruition with our Nu.Q platform at the very heart of epigenetic. But we say the epigenetic is as, if not more important than the genetic DNA in short, it's not DNA is 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 expansive IP portfolio to be a significant player in this key field. We also intend to further strengthen our supply chain for key components by bringing them in health. Overall, on so many fronts, without ever growing team and IP I'm delighted with the progress we're making. And I'm excited by the momentum we have developed in this epigenetics field. We look forward to announcing the next and hopefully final step in demonstrating the clinical utility of our Nu.Q capture for both sequencing and our immune assay approach in the first half of this year. Our whole team, including our scientific advisory board, who met just last week, is incredibly excited by the company's future opportunities. With regards to conference abstracts, posters and clinical papers, we hope to be able to release news around some of the major conference this year. Exciting times indeed. We aim with our solid cash position to report throughout this year and beyond several key milestones, including Nu.Q ability to detect a range of cancers in both humans and animals. In addition to our clinical data and Nu.Q Capture. We're absolutely delighted to be working with our collaborators from around the world, all of whom have outstanding reputations 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 the coming year with our optimized platform. We expect 2020 to be most exciting year yet. Thanks for joining the call today. I very much appreciated, given the busy earnings call season. I'm now very happy to take questions. Operator?

[Operator Instructions] Our first questions come from the line of Mark Breidenbach of Oppenheimer, please proceed with your question.

Thanks for taking the question. Cameron, I'm just wondering if, as part of the plans for 2020 include any side by side comparison of the new diagnostic format and its performance relative to your older micro tire place format. So let's start with that as a first question. Are we going to see any, like direct comparisons between the two this year?

Yes, absolutely. So thanks for the question. Yes. So the assay is the new beat based format as we said, it’s incredibly and basically sensitive so we expect very good results and the platform actually, the platform that we're demarking now is even that speed ahead of the place we had even two years ago because will be back- we've had - because the new types also include recombinants also includes in plasma non-theorem, all those things, so I think it can be difficult to go back to the place from three years ago, which even I can't place far better. But yes, look, we're having the key assays. We're not - we're only doing a few of them on plate now because the analytical performances is just really, really, really good on the base, I mean if we down to 1%, 2% or 3% CDs, that's a good the big - machine. So it's incredibly good, but we will have following benefits and also the market comparables, but I think you'll also see that in the panels where we've had, obviously we haven't optimized everything without checking that it's actually improving for the offense. And the results we've shown in lung, colorectal, and most recently, in blood cancers, the results were like we've never had before in one or two assays, that's what we didn't do big panels on small populations. But we can be side by side, but we're very hopeful for that results overall, and that'll be coming soon.

And just to be clear on some of the ongoing studies, specifically maybe the one you're doing in collaboration with National Taiwan University in lung, is that study using the new format or the old format and you know, I know in the past, you've guided we should expect a reasonable body of data from that trial in the first half of 2020. Are we still on track for that? Or are you in the process of switching sort of assay formats in that study?

So, the short answer is, everything we do now will be on the bead -based format, which is become so good and so to be a product and be robust, reproducible, all those things, which, obviously in the high throughput, the only thing that's going to be less than a low price is one or two assays, which we see marking, which are useful in the triage market where you add to some of those, relative to the assay showing to be incredibly good in the range of cancers individually but never got a product, we never want to further - so we are not to take one to that was going to be a blockbuster product in itself as a triage that is very good. So for every trial we do now apart from the triage, anything frontline or any of the others lung, colorectal are going to be on the bead-based format and instead we have four assays finished, we expect to have eight by the end of this quarter. So that's just next month, it's really picking up now where we really practice is a conveyor of those assays now, and that's on every trial we do, I think we're collecting a large amount of plasma. So, we expect to test it on the very simple platform. So things like triage, we will have the trial open on the range of assays for the most part one product, but also as you probably get from high department the team is also very bullish on the capture side, which holds the promise of more accurate, more sensible but more accurate tests along the lines of some of the other companies will include sequencing or precipitation. So we think what is as a continuing from the very low cost very one or two assays to still low cost bead-based platform. We are still at the under $10 for panel to a potentially even more accurate but more expensive in the hundreds of dollars, cost of goods, but potentially very, very accurate assay. I am not sure if you notice on the press release just earlier this week. We are combining a Nu.Q Capture with sequencing and I think if we can get it to work we will be getting - we expect very similar results to the big DNA companies that are now looking -probably now they are now looking at epigenetics, some of -really understand that somewhere between the benefits of methylation and nucleosomes in epigenetics. So, if you can bottle up together, but I think there's definitely a place for three in the market, there's a place for a very low cost triage in a similar somewhat three assays, there's a market for an accurate panel on the bead-based platform in a range of cancers. And there is also market I think, for slightly more expensive but very accurate test. And I think there's an extremely good chance to have that on the first two, in the coming months and this year, and certainly possibly either enabling technology or ourselves in the capture program as well. So all of our trials worldwide and in the best site just on that. So this strategy, we're also doing the best price, the Texas A&M team will now have all the tools and many Belgium if you will in the lab. So, they can also do the capture program on precipitations. They can also do the plate, they can also do the bead, and they can also use the bar analyzer. So we expect to be reproducing our basic platform in a very wide range of those this year. I think it's very fair to say we spent a lot of time getting the platform developed now that delivery, we need to show it works in a range of areas and published in big publications. So we expect all of that this year.

Okay, and just to be clear on the Taiwan study, should we still expect a chunk of data from that coming in the first half at this point?

Yes.

Okay. And one last one for me. Just because you're such a global company. I'm wondering if you anticipate that the Coronavirus outbreak is going to have any impact on your supply chain.

Not supply chain because we're very - one of good thing is being in control that any really two ingredients in our test antibodies and recombinant nucleosomes, so we now have them all in house. So not the supply chain but certainly it has been affecting some of our operations in China. China had been kind of slowed down for a month or two. So that slowed down a little bit but it has not affected so far Taiwan or Singapore and certainly not collection. But I said there's been a small effect on our operations due to - we are not tracking Chinese trials right now for obvious reason. - Busy I guess but overall supply chain was zero effect and will have zero effect because we produce them all internally. None of them come from China anymore. We've reported over half that I would expect some disruption in the trials in China and if it got a lot worse perhaps Taiwan but there's no sign of that yet.

Our next question comes from the line of Bruce Jackson with Benchmark Company. Please proceed with your question.

Good morning and thank you for taking my question. If I could, I'd like to talk about the veterinary business for a couple of minutes. So, you've got two studies underway. Can you tell us a little bit more about whether they're which animal so canine or feline? And then what are the assays that are being evaluated?

Yes, so the vet program, just quickly reiterate, we've shown very, very similar results in pre analytic as well as the results in the cancers. And one of the indications that we saw in little human blood cancers were at an extremely common cancer in dogs, particularly I believe Alceation and or German Shepherds but so we're recreating with half - recreating the exact lab in Texas. So we've done some preliminary studies, we are doing the pre analytics to make sure the collection protocols are very similar. And that's all looks to be very similar to humans, which are proving to be very stable. So our team there has been clicking samples from the hospital. It's a bit like a big clear lab next to a hospital, if you will Dr. [indiscernible] has their own animals and also there's a big facility downstairs. It's pretty remarkable facilities better than most humans are treated in the world. So, that's selected a range of samples, which we're very encouraged with. And now from bio banks and also collecting herself. She's taking hundreds and hundreds of samples, we focusing on dogs, and particularly I think, diseases is prevalence to different types of dogs. As I said, a lot of that is the blood cancers. But she is also got access- it's not public yet so won't you give the full details but we will do that in public and when we publish it, that she is accessing some very good bio bank as well as taking lots of stuff in the lab there. And, as I said to Mark previously, we expect results from that using a simple platform with the C Mark plate which expects ready by in the next quarter also still have the I-10 machine so they can run them on the magnetic bead, we've had fantastic analytical results. And that can be a very wide range of assay. And as exciting when we're doing it on the capture program, so that we'll see how capturing nucleosomes for the methylation markers, as well as sequencing growth on the animal side. So as in the human side, in Taiwan and around the world, we're going to have a very wide range of results this year. There is a very keen to publish and attend conferences and papers. I think there's going to be a big shift in the company this year. We haven't published a lot because we've been developing the platform. Also, we wanted to be sure about intellectual property before we fully went public with how it works. But now we're very confident with all those aspects. So, expect to see a lot of publications this year and the vet space will be a very important part of that the data, the process of putting all of those expected published in the vet space this year as well as in the human space.

Okay, great. And then in terms of the commercialization, how would this, how would these tests roll out to the market with this stuff? So Texas A&M has their own lab, for example, where they could start writing the test and selling it, would that be the first version that's available? And then somewhere down the road you consider going into a vet diagnostic platform? How are you looking at the commercialization process for vet test?

Yes, very good question. So yes, we're visited the labs as you know in October and they absolutely had a clear lab equivalent in the animal sense, but a clear lab in the basement so that we run a range of tests in there and as the trials go as well as they are going expect them to go very close. We will have the test running in their facilities this year and then that's running. They need a license to relate to the other big hospitals. But non-key ones, the kind of same hospitals where around the United States for the same purpose, and then go for US product. And also there are a couple of big companies in the space, [IDX, Mann]. We've been speaking to some of those groups also about building to other animals. We're kind of busy with dogs but cats, obviously, also a very big market that has revenues returns. So we've been looking most probably license in other animals because we can't -the model in early in all aspects has been to launch a few products that they think pump private if you will to start work and get it out there and then start licensing. So, I think we could start licensing in a wide range of animals to experts in those animals in the United States and worldwide. So, the short answer is yes. In the clear lab environment in the [Indiscernible] zone end we end this year, then a range of other ones around the United States and then other animal licensing.

Our next question comes from the line of Jason McCarthy of Maxim Group. Please proceed with your question.

Hey, good morning, guys. This is Michael [indiscernible] on for Jason. So I'd like to see if you could review the timelines on the human product, particularly Nu.Q triage and frontline, colorectal, as well as the one panel. And then also, when should we expect to see the data from the from the vet tests? And are those ongoing studies registration?

So, yes. [Indiscernible] the timeline for the product. And as I said before, I think it's been an absolutely phenomenal process we've gone through to get the assays as good as we possibly can robust, reproducible, and reliable. They can be a product, we have all the key components now, and we went out before. I get the whole technology was fully developed and it's worth that it's very tough to turn it into a product until you have it all, it's very basic vet finished. And it's been a huge amount of work. But as of now, I think it's very fair to say that all finisher growth has been finished so now about delivery and delivery means digest. I mean we really need to get out there and get the products out there. So on that continuing I was talking about with Mark from Oppenheimer to continue from the very simple the plate based format, with a couple of assays in the triage format. It's in the process of being C Mark now, the last thing for that product was the localization of the controls that's not finished. So that's now in process. So we'll have a C Mark kit, which has worked very well individually in a range of cancers. So the data in the lung and colorectal and in the blood cancers that was the core of that work. So once the C Mark will be using it in a range of trials which we expect to be product trials in the triage market, and things like lung, colorectal, the blood cancers. As far as the main assay platform, which everything else will be on, we have four assays finished. We expect to start the big trials once we have a bigger range 8 or 10, which we expect to have eight ready by the end of this quarter, which is early next month. And it's really speeding up. It's quite a conveyor belt of assays now that we've developed a very wide range of antibodies, a very wide range of recombinant nucleosomes. We very much understand the platform now and that's all the in house expertise to do it all. So from that, we'll start running the samples and stop releasing results on our main assay platform, which is the magnetic bead, and all the other improvements. With collection, we start very soon on the small and medium sized trials and then we'll start the regulatory trials probably in the second half of the year, once we've shown how well they work on the smaller regulatory trials, smaller trials and the big regulatory trials. So as far as data goes, that means from the main assay, [Indiscernible] we would expect the first trial and very meaningful numbers very low p value. So it'll give you a very good indication how it's working in the coming -in the next few months in certainly two quarter to quarter three, and then should that go as well as we expect to start the biggest trials in the second half the year with a aim of launching product in 2021 in Europe and Asia, on the frontline products in lung and colorectal and perhaps blood cancers. And in the US in 2022. So and on the vet side is quicker than that, because it's much smaller trials and needed and less regulation and it's clear lab environment, where it launches product very quickly. So expect to have that first product launch this year and a range of products potentially in a range of species next year and the market for this space is potentially as big as the human cancers for the reasons which we discussed. The two and a half times when we dog diagnosed in US as humans, for example, because they get cancer so young, and the parking structure is actually quite similar to the human market. It's amazing how much we spend on that four legged friends. So and we're also going to augment that with some revenues from now we have bought Octamer and there this revenue coming in there, this year we expect from the nucleosomes cells, also what is realizing the research use market from just being on place to also be as a service model. We had one test in that last year, which was a very big percentage of revenue last year was where we ran the assays of the service, very high margin business and it allows us to keep control of their understanding who's using our assays. So expected it is not based on that this year. But -the last two years has been getting our assay and the platform developed and all capture side which the team - I didn't even mention all that. But that's potentially revenue next year as well to develop so it's absolutely as good as it can be. And then this year is about getting the data and first revenue from the first product. The next year and the year after, where we can really take it home in a very wide range of areas on the platform and in a range of diseases in a range of animals. And on the capture side.

Thank you and then actually on the Octamer stuff. I like to see if you can actually give us a bit more color on the revenue opportunity there for selling the histone, the Octamer and the DNA template?

Yes. So this is something where we're looking to do how much effort we put into it. You're looking at so basically, we've far more get into secure and supply, because it's very few pieces - it's very new thing to do. And very, very few people in the world can do it well, so it's very important to bring it out. But revenue wise, rather than that, it depends on how seriously we take it, how much we're going to be selling. It is a very high margin business and that we make very predictably sense for ourselves. We'll update you next quarter. But you're talking revenues in the tens of thousands per month to start with in the first year. But if the pharma companies really take on these nucleosomes and drug development programs, it could be becoming millions in the years to come. Because there's very, very good nucleosomes, very few people do them. But I think if you are looking kind of the next deal or two in the tens of thousands, and then if we take it seriously and really pushed the boat out and pharma companies, and I think we bought this company because they do fantastic nucleosomes, it could get big in so 21 and 23, but in the tens of thousands this year would be reasonable, where we are moving to the hundreds of millions. But I think this is a kind of a- if you look where we are, the epigenetics, which is what we do, has absolutely become mainstream. And the DNA companies are moving towards epigenetics through sequencing and survival by conversion, which is we think the wrong way to go about it. It's very complicated, very expensive. I think that barring our epigenetic toolbox, which is through the capture program, nucleosomes, as well as the antibodies, we can not only provide intellectual property to license, but all the aspects of the test to really keep control of everything we do. So, I think it's something which could really take off in the next couple of years from the new agent side as well as the cancer side. But we're just going to read that ourselves. What's the next year, how big we want to get into it as selling kits or services or nucleosomes? But I think there's very little doubt now that the space we're in is incredibly important and it's going to grow exponentially over the next couple of years. So I think it'll make sense for us to dip out to the network before making nucleosomes for ourselves, and maybe we'll be selling them to other groups as well. So, that'll become to next quarter. But it's an aspect which we're taking very seriously and thinking a lot about. And when we finish that process, we'll make it a public.

Thank you. And then just one more, I'd like to see if we can focus on capture for a second and more specifically, the how behind it and the liquid biopsy space, what is really the advantage of enriching for nucleosomes compared to traditional methods for isolating CT DNA?

Yes. Very good question. And I feel good to have a chance to talk about capture. So currently, you probably aware there was a huge promise among sequencing in the past 20 years, it was going to solve every problem and I think that companies have done a very good job at taking selection, they said monitoring. But I think it's also a very competitive set of old files, early detection from DNA, because you're looking for the needle in the haystack of haystack. So now we're on magnetic bead. We've always just used the plate format, which is a very simple and good format. But once your magnetic bead that helps you manipulate nucleosomes in machines being magnetic, but we're also crucially does if you pull the nucleosomes out using magnetic, that's a very simple process, we call a meter precipitations while it's called immunoprecipitation. So, it's a simple approach, this is what assay is. So, whatever we do on the capture antibody on the magnetic bead is pulled out for concentrated for example, long versus short nucleosomes, short nucleosomes to been shown in Nature paper to be more prevalent in the cancer. But you can also pull out for things like methylation patterns, for example, which is where all the DNA companies are getting this discrimination now if the epigenetic feature of methylation patents. So, if you can, and we can pull out the nucleosomes and preferentially pull out by certain structures, methylation, or long or short or link DNA, you are really clearing out the pool as we say, if you're looking for a needle in the haystack, if you can sweep away the haystack, you can make a much better job of sequencing, and in concentrate by methylation patterns, for example. And a combination of all of assays and these things, and even transition factors, which we're working on now, which is has proven to be very tissue specific, you can do several things, you can clear out all the background noise, which should greatly help the results. You can also concentrate the nucleosomes from the cancer, which should really help with sequencing. And you can also do it - if you look at it this way. It's not just the DNA. It's the whole chromosome structure which has a much, much more deeper signal than just the DNA itself with the DNA companies have realized that the only thing that can really target the epigenetics side is the methylation levels and that through the sequence or by corrosion or the gels, which only do lung from sure, is not a very easy, cheap or quick way of doing it and it's not proving at all accurate early stage detection just over also pre DNA. So, we think it's actually doing a lot of favors for the moving to the epigenetics type, the proving through this complicated methods, you can actually get good discrimination in the epigenic space. But our method is far easier, far quicker and far more powerful way of doing it, when you can concentrate from any single structure of the hundreds and hundreds on the nucleosomes. So now we're concentrating about seven different structures and also very different things. So I think it's really fair to say advisory board, our team, absolutely extremely excited about the potential for the capture program, not only have our assays and our program, but really make a step change in epigenetics, and in the cancer diagnostics and in a range of other areas. The whole convergent segment is the key, not the DNA by itself and that's something we absolutely win a lot of work on this year. And if we can show any of this it'll be a massive breakthrough and a very big publication and really help us in products. We have reached the end with a question-and-answer session. I will now turn the call back over to management for any closing remarks.

Thank you very much for your time. I'm very exciting time for us then we're looking forward to seeing all of you over the next quarter as we deliver the results which we've all been working on for a long time now. It's been 10 years and we have a lot going on. Also June 1st, we're doing the Capital Market today in New York again on the New York Stock Exchange. So anyone who could attend particularly the analyst side will be very helpful. We intend to have a lot of data by then and also quite a few of our experts you can really get in depth with on the questions. So June 1st will be a big day for them. Thank you very much for your time.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. And have a great day.