VolitionRx Limited (VNRX) Q2 2019 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen and thank you for standing by. Welcome to the VolitionRX Limited Second Quarter 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 open for questions. [Operator Instructions] This conference is being recorded today, August 13, 2019. I would 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 second quarter ended June 30, 2019 along with a discussion of our recent activities in key upcoming 2019 milestones. Following the 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. Dave Benston, Chief Financial Officer. Before we begin I would 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 Volition’s conference call today. I'm happy to say that we have great momentum and have made strong progress on many fronts over the summer months, in platform development, with our colorectal cancer and lung cancer work, with Nu.Q Capture our Asian trials, and of course with Nu.Q Vet. Firstly, let me start by reiterating our vision and what makes us so excited with our progress and our space. Since the human genome was first published in 2001, there have been tremendous advances in DNA sequencing technology. Billions of dollars have been spent to buy several well-known companies, and a wide range of research groups, and great strides have been made in sequencing cancer mutations for drug treatment selection. However, there appears to now be a growing realization that the DNA sequence is only one part of the picture. And it's unlikely, for example, to be clinically useful for early cancer detection, in most or many cancers. DNA does not occur in isolations, but exists in cells as chromosomes made up of DNA and proteins in nucleosomes. The DNA essentially forms the recipe book for making all human proteins. But like all recipe books, we don't make every recipe every day. Some recipes are made often and others rarely, some are never made. The DNA recipes are just the same with protein dishes being made when it's determined by the epigenetic state of the chromosomes. Many human diseases, including cancer, are caused by a loss of normal chromosomal epigenetic regulations. Volition is an epigenetics company, focused on advancing the science of epigenetics and exploiting these advances in human health. This has been our mission since our founding, and it's now coming to fruition with our Nu.Q platform at the very heart of epigenetics. So we say, the epigenetics is as if not more important than the genetics, the DNA. In short, it's not DNA, it's the full chromosome. We believe the last decade of work and evolution without ever expanding team in epigenetics, puts Volition in an extremely strong position with our expansive IP portfolio to be a significant player in this key field. As you are aware, we have spent a great deal of effort over the past two years developing our assays to final product grade, with many improvements, including monoclonal antibodies and using recombinant nucleosomes as calibrants. Something that was impossible just a few years ago, and now it's routine in our assays. In addition to finalizing our assays, we have done extensive work reviewing blood collection protocols to ensure every aspect is optimized. I'm absolutely delighted with the progress we're making. On our last call, we provided the first data regarding the performance about finalizing Nu.Q assays in two lung cancer cohorts and one colorectal cancer cohort. As of today, we have now utilizes this assay in eight separate discovery cohorts across five cancers and [indiscernible] has performed well in all studies to-date. Demonstrating its reproducible and robots nature on manipulate [indiscernible] platform. In order to ensure our tests are accessible around the world, we have also undertaken broader work on our platform, including adaptation of our assays to chemiluminescents and magnetic beads. This is a format which is used by all the leading global diagnostic companies such as Roche and Abbott, as well as a large range of smaller open platforms. This has allowed us to start work on a cutting edge auto analyzer platforms in Europe and China. I won't go into great details here why these are both very important breakthroughs. That could take this entire call to explain. But that made our platform much more robust and importantly more adaptable from a plug and play point of view. We aim for our test to be usable on as many platforms as possible to be truly available in any lab in the world. Our R&D team has made fantastic progress and we expected to grow to more than 40 people by year end, while still keeping our burn rate relatively consistent and low with our prior quarters. And so, to the all-important financials. We closed out the second quarter of 2019 with $18.5 million in cash and cash equivalents versus $13.4 million at the year-end. And I'm delighted to announce that subsequent to the quarter end, we further strengthened our balance sheets with non-dilutive funding and exercise of our outstanding warrants. Our long standing invested exercise $4.8 million in aggregate amount of outstanding warrants to purchase shares of our common stock, bringing the total cash received by the company upon receipt of warrants by existing shareholders in 2019 to date of $16.5 million, showing very strong shareholder support. This brings the total cash on hand at June 30, which was $18.5 million, plus the $4.8 million in warrants exercise in cash to the quarter end to a total cash amount of $23.3 million, which is enough to take us through to 2021. The proceeds from the most recent warrant exercise were from warrants previously issued to an investor in a private placement in August of last year. Such warrants have now been fully exercised. It is a key part of our financial strategy to actively seek non-dilutive funding, as this provides additional cash at favorable terms to the both the company's continued development. We're delighted to have been granted additional $1.4 million of non-dilutive grant funding smaller in region this last quarter. We are extremely proud to be able to announce that we have done all the work of this mentioned with a slightly reduced quarterly burn rates of just under $3 million. Although we do expect the monthly burn rates to go back to $1.2 million $1.3 million monthly trend. We continue to manage cash carefully and believe that we are in a very sound position with regard to the financial runway to achieve our 2019 key milestones and beyond into 2020. During the second quarter, we were delighted to announce the execution of a contract with a national Taiwan University to conduct our first large scale lung cancer study, which will include 1200 subjects receiving low dose computed tomography scans, including 1000 with lung cancer. And I'm happy to announce this has now started collection. At a total cost of approximately $320,000, payable over two years. This study demonstrates once more Volition's commitment to conducting large yet cost effective trials worldwide. We are very hopeful that our recent proof of concept results in lung cancer will be repeated in this much larger cohort and expect to release preliminary data relating to the initial 600 patient samples in the first quarter of next year and the remainder by the end of next year. Thirdly, we're excited to have formed a new Texas based subsidiary Volition Veterinary Diagnostics Development LLC and we appointed and welcome its Chief Executive Officer Nason Dewsbury to our team. Volition Veterinary will focus on the further development and commercialization of new key vet products and help drive early revenue for the company. On the veterinary front, we were also delighted to sign a memorandum of understanding with Texas A&M University early this quarter and aim to have more news and data report on the Nu.Q Vet in the coming months and quarters and revisiting Texas with several team members in October to hopefully strongly advance this process. And more recently, we're also excited to have executed a contract with Shanghai Fosun Long March Medical Science Company Limited to introduce the Nu.Q Vet platform to China. Based on our recent promising proof of concept data using product rate Nu.Q assay, the parties have committed a lung cancer study and aim to complete this study by the end of 2019. And so to the view of the second quarter. We're delighted that our first finalized product rate assays are performing so well and look forward to reporting data from our further small scale clinical studies and subsequently our large scale clinical studies, in addition to news about many assays that are in the development pipeline. As I said earlier, we have now utilized this first assay in eight separate discovery cohorts and across five cancers and confirm it has performed well in all studies to date, demonstrating its reproducibility and robust nature. We're now stepping up work on these trials and preparation for abstracts submissions for upcoming scientific conferences are underway. And we expect to submit at least one clinical paper application in the coming months. I'm delighted to say that our worldwide portfolio of grants and patents that protects various aspects of Volition's Nu.Q technology is growing steadily. This is yet another key differentiator with the many other technologies under development or available in the market. We have 20 patent families related to our diagnostic tests. With seven patents grants in the United States, seven patents grant in European Union and a further 25 granted worldwide. Additionally we have 16 patent applications in name of our subsidiaries,, mainly in United States and 13 such applications in the European Union. This portfolio also covers veteran medicine applications more of which I’ll cover later. We intend to continue our development of the Neucleosomics technology and will continue to apply for patents for future product developments. Our strategy is to protect the technologies and gain market exclusivity with our patents in Europe and United States and in other strategic countries. We believe that the patents on the technology underlying our products should provide broad coverage for each products including protection to at least 2031. It is important to form our evolution revenue subsidiary to enable real focus on the development and commercialization of our Nu.Q Vet products and help drive early revenue for the company. We are delighted to welcome Nathan, a highly experienced business development advisor and Texas A&M alumni to our expanding team. Nathan's global expertise in the animal health industry, having direct involvement in the national testing programs carried health diagnostic platforms and commercializing next generation diagnostics. He has a strong background in launching new commercial teams as well as launching and growing successful animal focus startups, all to achieve global impact in the lives of animals. He was educated at Texas A&M University where he received both the science and business degrees. Volition's recent proof-of-concept studies demonstrated that Neucleosome can be detected in dogs and therefore the potential to differentiate cancer from other conditions. We previously announced the execution of a member of member undergoing the study with Texas A&M University with the intention to collaborate on the research and development veterinary diagnostic products and make larger trials in veterinary medicine to test Nu.Q platform are carried underway which result is expected in the coming quarters. U.S. is currently the largest veterinary market in the world with more than 55 million dogs and approximately 4.2 million cancers diagnosed each year. It has the clearly defined regulatory pathway by the USDA, requiring fewer and smaller clinical study than the FDA process for human diagnostics which generally allows a much faster rate of revenue for veterinary products as compared to human products. Volition’s extensive intellectual property portfolio includes coverage of veterinary applications and we believe that not only could Nu.Q Veterinary potentially provide significant revenue provision, it may also provide further technical validation of our platform in human diagnostics. From a commercial point of view we’re extremely excited about the possibility of offering Nu.Q Vet test to animal owners and veterinarians. There are currently no accurate, simple, affordable cancer screening tests available in vet medicine. And yet 25% of dogs who developed cancer at some stage in their life. As in human diagnostics, early cancer diagnostics can be medically improve outcomes. Our preliminary estimates of what a diagnostic test would sale for the vet market are approximate equivalent to what we would chart in the human market. We currently expect passing [ph] to be between $100 and $200 per test and we believe that the veterinary market is a multi-billion dollar opportunity. Consequently we are taking this opportunity very seriously with Volition Vet moving forward as quickly as possible with the aim to have the first Nu.Q Vet product on the market in 2020. We aim to have more news and data to report on Nu.Q vet in the coming months and quarters. We were delighted, in second quarter, to see a so many of you in the Capital Markets Day in Auckland. During the event Professor Axel Imhof outlined the progress to-date with Nu.Q Capture project. Professor Imhof is a newly appointed member of our scientific advisory board and a professor for protein analytics at the Biomedical Center of the Ludwig-Maximillan University, LMU and the Director of Proteomics Core Facility of LMU's Biomedical Center. Our Nu.Q Capture project leverages the work we have been doing to investigate the use of Neucleosomics to purify or enrich tumor associate nucleosomes. As previously announced with Nu.Q Capture, we have been able to replace nucleosomes by 70% to 90%, using magnetic beads in serum and plasma based on unissued studies. The next step it is to determine the level of discrimination of tumorous associated nucleosomes using mass spectrometry and sequencing. This potential breakthrough product aimed to enrich tumor associated DNA which in turn help address the main technology barrier to DNA cancer diagnostics. Nu.Q Capture is platform diagnostic with the ultimate aim providing complete nucleosome analysis and origin of cancer. This is still very much a work in progress. But we have made significant progress this past year. And our team is very excited about the potential addition to our platform. And so to future milestones, as many of you know, we have concentrated our research efforts to date on colorectal cancer, which is the most preventable and yet currently least prevented form of cancer. And we very much look forward to completing our large scale clinical trials throughout 2020 and '21 worldwide. We have been in discussions with regards to our U.S. study GLNE10 [ph] partly funded by the National Cancer Institute. We will update once we have the final agreements, but it looks likely it will be merged with GLNE7 [ph] to provide a larger number of cancer patients in the trial, due to the lowering prevalence of cancer in the screening population. We view this is as a positive outcome, and we will provide additional disclosures once finalized. In addition to our colorectal cancer studies, we are hopeful that our recent proof of concept results in lung cancer will be repeated in much larger cohorts. Starting with the 1,200 cancer cohort now being completed by the National Taiwan University. Lung cancer remains the deadliest of all the cancers. And there's a high unmet clinical need for either a non-invasive early stage lung cancer detection test, or for a test which can improve the specificity of the low dose CT scan currently used in many markets. The need for simple, easy to use, cost effective tests for cancer is truly universal. And we hope very much that our Nu.Q tests can help revolutionize the way cancer is diagnosed worldwide. We see Asia, particularly China as a key market for Volition. While as China represents a little under 20% of the world's population. It accounted for almost 24% of cancer diagnosed and 30% of cancer related deaths worldwide in 2019. Almost a third of which were due to lung cancer and colorectal cancer. We're excited about the commencement of our work in China, and look forward to completing the studies and successful collaboration with Fosun Long March. We also aim to begin the process of key marketing for Europe and registration in key Asian markets this year for our first lung and colorectal cancer Triage products. And we will provide further details over the coming months. Our mission is simple to save lives by revolutionizing the way disease and especially cancer is diagnosed. To this end Volition is developing simple, easy to use blood based tests to diagnose a range of cancers and other diseases. Cancer is still the second leading cause of death and is responsible for one in six deaths worldwide each year. It's a disease that touches and affects so many of our lives. It's widely accepted that the best way of tackling cancer is for patients to receive an early diagnosis. As this improve the chances of surviving. We aim with our solid cash position to report throughout 2019 and beyond Nu.Q's ability to detect a range of cancers including lung, colorectal, ovarian, prostate, pancreatic, and include preliminary data from our first studies in China in addition to progress updates on the Nu.Q Vet and Nu.Q capture programs. We are 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. We believe that Nu.Q will provide a low cost routine blood test, allowing doctors such as cholesterol and PSA during a single visit. And this is the only currently available credible pathway to detect compliance to screening above 80% worldwide. Volition is an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human health. This has been our mission since our founding, and it is coming to fruition with our Nu.Q platform at the very heart of epigenetics. Remember, again, it's not DNA, it's a full chromosome that's important. We believe the last decade of work in epigenetics puts Volition in an extremely strong position with our expansive IP portfolio to be a significant player in this field. We're extremely proud of the accomplishments we have achieved thus far, and look forward to what the future holds at Volition. I along with the rest of the board, and indeed the whole company, look forward to sharing the results of case studies over the coming year with our optimized platform. We work hard every day to create a brighter future, one where hope and cancer can come together in the same sentence. Thanks for joining the call today. I very much appreciate it given very busy earnings call season. We're happy to take questions. Operator.

Thank you. We'll be conducting a question-and-answer session. [Operator Instructions]. Our first question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.

Hi, guys. Congratulations to the progress especially those warrant exercises seem to be providing a nice flow cash.

Thank you. They really are.

For the China lung study with Fosun. If you are in a fairly rapid completion of the trial. So could you give us a bit more color on the size and how the costs are going to be split between you and your partner? And then …

So I said on just the first question. There is a small cost involved in Chinese trials, there are a few hundred samples per cancer. Just to show the efficacy of the kids when they shipped around the world that being conducted in China with the Chinese team. So it's all for the three trials in lung, ovarian and colorectal. It's under $100,000, which is coming to our account, because -- and we're providing the kits that we can keep control that it's done properly. And we expect the first day to have that from this year, if lung perhaps some of the other ones as well. And so what was the question on the Taiwan side?

Just wondering this played into the Taiwan study at all.

Sorry? Separate -- completely separate. Yes. Sorry. I didn't understand that. That’s completely separate. Different PIs, different groups. It's from the National Taiwan University's long unit, which is a 1,000 cancers and a couple of hundred health ease, which will give us a very broad range of different lung cancers and different stages, after low dose CT scan. So it'll give us the potential product from a Triage point of view in lung cancer, when in conjunction with low dose CT, and then hopefully also some good information on as a frontline test. Separate from both sides, it should be a very good trial and a $320,000. I guess like everything, it's incredibly good value. If you're doing that in the states, it'd be thousands and thousands, 10s of thousands, that's per person. So but we are funding both of those trials. But obviously to be such a low cost base, there has to be some support from the local groups because they -- if you are funding all the actual cost of all that will be much, much higher. But yeah, we're very happy with lung space and very confident of the data coming through late this year and early next year from the two different lung trials. And as we have talked about their potential massive products given the very deadly nature of lung cancer and growing and deadly probably in Asia in particular.

Thank you. And then on to the colorectal side. Which is the largest study should we expect to read out in the near-term? And the current data pipeline kind of sufficient to support regular filings? Are there any other trials that maybe needed?

The first product, as we've always expected, I believe will be in the Triage space in CRC. So we're doing the -- we've actually picked a panel now for our Triage product. We did have one before, but this is with our new, fully optimized assays. So we'll have some news on the data on the Triage in the coming months. Certainly this year, but we expect to see hopefully sooner this year. And that we expect to get a regulatory approval in Europe and in Asia starting in Taiwan. And perhaps some U.S. work which we're talking on, but certainly in those two. On the frontline products, the trials are being quite as we talked about with the GLNE in the U.S. We expect those readouts in 2021, it's a very large study. We intend to be the FDA regulatory trials. So that does take time in the states. The halfway through collecting the samples in Taiwan for the 7,000 samples there. So we'd expect some data on that in the next 12 months as well. And we've got all the European trials, as we've been talking about for a while now. So for the frontline product, the Triage product in and one product, the first one, as I discussed will be on the very simple platform that's right there in both of those cancers in the small trials. So we'll be launching the first product on that simple platform. But -- as we talked about, we're adapting the assays to be on magnetic beads now. The feedback from a lot of the groups was the big hospitals if you are going to be worldwide wanted to be on some several plug and play platforms. So we've got from that now. So all of the assays as they come off, the line now will be actually on the magnetic beads for that. So that they can be run quickly and easily for the trials and also for the products, the frontline products. So that would be our mantra going forward. The research kits and the simple products will be on the simple plate format. And everything for the larger products and letting the plug and play techniques from the base will be on the base. So that allows us to sublicense very quickly. And also, as I said in the call, we will definitely get to a couple of platforms now. And it's prudent reasonably easy platform the platform once it's on magnetic beads and pulse can move in essence. So very excited about the expanding platform. And the timelines are, as I said.

Thank you. And I just have a one quick one just for some clarification, you mentioned that you're going to begin the CE marking product process on some of the products I think you said long and CRC Triage. You said, that will get started this year?

We've started the process. So it usually takes around six months. So I'd expect that in the early part of next year, to be finished. We've picked a panel for both the Triage on the colorectal and both lung. And we're in process now of starting to CE marking and some regulatory work in Asia, starting with Taiwan, because that's where a lot of the trial work's done. So I'd expect to see that completed in the first half, hopefully the first quarter of next year.

Right. Thank you very much.

Thank you. Simply done.

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

Good morning. And thank you for taking my questions. With the -- so with China, you had a -- there was a company and one of your competitors where they had a patent review. And it was found to be valid, but not covering the area of testing as they wanted to cover. And I'm just kind of curious about how you feel about the strength of your IP in China and what you've done to protect it?

Yeah. China has become quite vibrant. China is a tricky country for IP, I guess there's a lot of opinions, a lot of different areas about how to best deal with China. We've spent a lot of time with us, we have a team in Asia, as you know, headed up by Dr. [indiscernible] a small team, but we have a team there. So we've spent a lot of time trying to find the right partners, and make sure that our IP is supported. Now we do have patents applied for and grounded in China. I could have economical with Jake, Dr. McAllister is our IP guru, he can go through all that with you. But we are very happy with the patents situation worldwide, including China. There can be IP issues in China, absolutely. So it's up to place you do have to be careful. We've done a lot of work, we've spoken to a lot of different groups in China. Fosun has a very good reputation and they're very international, they’ve done a lot of work in this space. And a lot of other spaces probably seen that be involved in Thomas Cook and a few other things internationally. So we'll see how it goes with them. They've been very good and responsive so far, they've got a very good reputation. But there are other ways we could get into China if for whatever reason we decide that they're not the best for us, but at the moment it's working very well. And but we Scott and myself and a few others have worked in China quite a bit. We understand the potential pitfalls. But it's a massive market and one which we need to address. So we've thought about very carefully and we've come through with the Fosun group. But we have also moved very aggressively protect our IP as well. But I think it comes down to having a trusted partner like anywhere else you really don't want to get into a patent battle if you don't have to. So we're looking for the best partner to help us with that commercialization and so we're happy with the progress so far.

Okay, great. And then with the CE mark in the two Triage shots, I just want to confirm that the two Triage shots for colon cancer and for lung cancer, these are your two lead product candidates right now. And you anticipate finishing the CE marking process sometime next year? And I'm also assuming that now you've got the commercial grade assays for both of those tests ready to go, is that the case?

Yes, and yes. And actually hopefully possible when you say next year. We're trying to be conservative, I would expect to be in the first half, if not the first quarter. But yes, certainly next year and certainly would hope it's early in the year. And yes, the IVDs are because of the simple format which is which we’re using from day one. They are commercial grade Assays and they're ready depend on, we've chosen all situation where we can get them for as an IVD and CE mark the final product right assays. Absolutely.

Okay. And then last question for me, on the vet products. Are these also the commercial grade assays that you are going to be using for those for those tests?

So just to be clear on the vet side, we don't have a product, we have not picked the panel. We're just setting up the company, we've obviously had some encouraging results that make us confident to spend the time and the effort on this. And we've chosen a fantastic partner who's very cognizant of what were the assay are and what the best space is. But we have not chosen the assay for the product like in lung and colorectal. If they are the same assays in humans then they are heavy these days. But we will be trying -- at where we are, we've had some encouraging results, which gives us a very strong confidence to move into this space. But we're doing we're learning from the human space and doing the paralytics first, to make sure that the blood conditions and the collection protocols and everything are similar in doctors and humans. So, I think it's very realistic, I think we have a product next year, because the best stages of our assays and the partners we have. But we are not in a situation now where we could tell you which assay is for which conditions. So there are a lot of other diseases beyond cancer in dogs as well, which could be useful in inflammatory diseases as well as other things also. So we'll have updates on that and we've spend a lot of time on that now finishing off the company. We're just finishing off the final work with Texas A&M, hopefully, so we can announce exactly what that relationship looks like. But it's something we're very encouraged, very happy. But we're not in a situation now where we possess the test.

Alright. Well, congratulations on all the progress. And thank you for taking my questions.

Thank you. Very welcome Bruce. Thank you.

Thank you. Our next question comes from the line of Mark Breidenbach of Oppenheimer and Company. Please proceed with your question.

Hey, thanks for taking the questions. Cameron, sounds like there's a lot of moving parts here. And I was wondering if you could give us an update on where we stand with the finalization of the panel for the asymptomatic CNC [ph] screens? And also it maybe it would be helpful if you could just clarify what readouts we're really expecting in the back half of 2019, let's say in the next six months or so? What should we what we should be expecting in terms of data?

Yes. So the product line production mentioned, obviously, the Triage for lung and colorectal. We picked the panelists a simple format that we run with before. And I think part of reason for that is very good when you using with something else, it's often the keeping the whole thing very low, with much less pop was, much more likely to be used. We're very happy to all of that. We're just finishing up the work on the assays as we talked about before. The data we had from the last earnings call, where we were in the 80s to mid-80s just for the [indiscernible] assay. I think we're getting close to where we needed to be. We'll update more on that when we think we've got to the final panel for the frontline. We're not there yet. But we're very happy with the results that have been coming through. And the decision has been taken. And I think it's a very wise one is to launch products on chemiluminescent-b, so that it can be the last one product and changes. It's going to, obviously, to be everywhere in the world. And every platform, which I think is very achievable now given what we know and what's been going on. We will not launch the product on magnetic beads. So, I just thought that I think if you look at all the work being I mentioned it quite a bit on the call, but just to be clear where we think we are is a huge amount of interest in the space. And it's really coming towards epigenetics. If you look at the big companies that now own status, as far as I'm aware that they're going to need to add epigenetic signals through the DNA to anything approaching early signaling, through methylation or [indiscernible] and a few other areas where we think the best and easiest way to do that is actually with a new persona themselves. And for a very simple format. So we're very happy, very encouraged that that tide is up to nine years of thinking what we are doing is going to be a big part of the answer. I think that's become common thought now that the epigenetics has to be incredibly important. So the rate out through the rest of the year. I'll just go through the each indication, the major work in collateral will be some readouts on the Triage products. We've obviously had read outs before, but that was not a platform which was stable. We are now very happy with stability. We picked the panel for the Triage products. And we running several trials to run through the data would expect that this year as well. On the one side, we expect to get quite a bit of data from China, particularly in lung. In Q1, we would expect to get the biggest lung data from Taiwan. Volition Veterinary, I would expect either late this year or early next year between now and Q1 to get the first data on the first products from the west side. Also, we've been working a lot of other smaller trials with RSAs another proof of concept in other cancers and things like endometriosis. We're also running now, we're very happy with the stability of the assays. We will have some data in a range of cancers, including ovarian and some other issues, which we probably expect to publish. Data wise too, we're doing a huge amount of work on the background, which is really quite groundbreaking work. We'd also expect to publish that with some more of the data. And we add abstracts, at conferences and in publications. I think we've come to a lot of very good conclusions as to how our assays should be to be worked in the final product in grade level. So that'll be something which were marketing as well. And then on the vet side, apart from data, we also should have the relationship with Texas A&M clearly defined. We're very excited with the possibility of them working with us in collaborations on the on the vet side. So we expect to have that. And the dark horse and all of this, the Nu.Q Capture. We've now absolutely captured Nu.Q components and completing. So now we're in the process of sequencing and doing the mass spectrometry. So we strongly expect in the next few quarters to have some data on that too. And that's potentially an early revenue source next year as well, because that's a licensing opportunity. If we can indeed capture and remove neucleosomes. And if we can show that clinically useful for the DNA space or any other space that would certainly be a licensing opportunity in the next 12 months as well. So a lot going on. And it is all you mentioned, quite rightly, is a lot going on. But it's actually very closely connected. For example, Nu.Q Capture has been made possible by the magnetic beads, which is also the platform we will be using for all major products going forward. And also, obviously, that's been helping very much in assay development for the veterinary side and all the cancers. So I think we do have a small team, we have kept the burn rates remarkably low. And as you probably noticed, it did this last quarter. So it's not ballooning left, a lot of people thought it's actually just below $3 million this last quarter. We expect to go back to trend that we've been very careful with money, we've raised a ton. So we should be in a very strong position to get all these milestones delivered with what we have. So it's very exciting. And as I said, I think the space is really opening up for us now.

Okay. And sounds like really the Taiwanese lung trial is the nearest term large data set we can expect from you guys. And I, I'm kind of curious to hear of what you would view as a positive outcome from that trial. What you're hoping to achieve before continuing development in that setting? And also, I noticed that a lot of the patients in that trial, looks like about 1000 out of 1200 are positive for lung cancer. And I'm just wondering if that's really representative of a broader population of patients who would be referred to a low dose tomography scan? Or is this basically being enriched substantially for lung cancer positive patients?

Yeah. Just make sure I get those questions correct. So the lung, I do expect large readouts in the colorectal space in the next six months, initially in the Triage space, which, because we have improved assays, we would expect to have improved data. I think the cut offs were very good last time. But I think with our improved assays, we should get considerably better results in our certainly product where the last time again, the problem with our platform. So I would expect that data I would certainly not say there's not going to be nothing else, there's a lot of CRC coming through. And once the assays are ready, we'll be running this the large colorectal trials, but we're running them through now. So just to be clear, on the lung side, there is a lot of lung cancers, we decided to go quite lung cancer heavy, because that to make sure that we can be very physically significant through the stages in the process. So these people have all had low dose CT scans, and will have matched match trophies [ph]. So the first product in every phase, I think and while we're talking about lung Triage, as well as colorectal Triage. The easiest thing to do will be running the trials with the IV, IVD approved products we expect in the space so that they can become products quite quickly. But the message we've got from clinicians here is the big help they need today is in the screening programs like in the U.S., like in Taiwan, where people are given low dose CT scan. It's extremely sensitive, but it's not very specific. So that said, and I've end up giving a lot of people biopsies and late stage detection, which is really quite invasive and dangerous if it's not needed to be done. So the feedback was, could we give a blood test before after either to help compliance or to help with specificity. And given the disease we've had in the lung cancer trials with the one low dose CT scans, which is a lung trials, there was a strong expectation that we could actually very much help. So in the interest of getting revenue as quickly as possible a frontline test obviously has to be quite specific in itself and very sensitive in it by itself which we expect to get to. But just with the assay we have now we've had very good results. And the clinical conditions worldwide, actually, this is also in the U.S. have said anything that could help with specificity in conjunction with low dose CT scanning, after or before they help compliance will be very useful and widely adopted. So this trial will give us a strong indication as to the frontline detection rights because we do have cancer and healthy. And you can obviously, you don't have to have us only cancers, you can split them into match the healthiest to get a more accurate population. But in the first instance, this will be seen to be used as part of the pathway currently in the low dose CT scan pathway, which is the only pathway really out there worldwide, in anything approaching screening worldwide. So it's a very good way to start. So I have given the results that we have. And we would be hopeful that we could also screen high risk groups, I mean, you'd have to be very specific to screen everyone in the population lung. But high risk groups, smokers, anyone who lives in China, any polluted cities would be one of them as this process. So we're very much working on that. But that's how that would all fit together. But we'd also strongly expect to see I see data in the next few quarters as well as I outlined.

Okay. But in terms of the high ratio of patients who actually have cancer in that trial, can you comment on that?

Yeah. So we went for high rate of cancer, that was, we work without PI there, what they were looking for. So basically, if you only have 50, 30, 40, 50 cancers, it's very hard to get large groups and representative to make sure stages of cancer and all different types of lung cancer. So it fits perfectly. And this is what the conditions we're accepting for their product needs. For everyone who has a low dose CT scan, could we have actually had checked them specificity wise, to make sure that they actually low dose CT scan with a good process. So this is the design we worked on with the clinicians in Taiwan. And this is what I wanted to really see if I could get that product. And then we could work to further trials on the frontline screening test. But this should give us a very good indication on the frontline way. And also for their primary initial aim, which is something in conjunction with low dose CT scan. But again we do offline and with a statistical team. That is something we thought about very carefully. And it's what we came up with our investigators in Taiwan.

All right. Thanks for taking the questions.

Thank you.

Thank you, John.

Thank you. Our next question comes from the line of Brian Marckx with Zacks Investment Research. Please proceed with your question.

Good morning, Cameron.

Good morning.

Good morning. You reference referenced competitors in the space that are including genomic biomarkers in their blood based cancer tests in order to enhance their performance. I'm just wondering if you can talk about what your thoughts are on their ability to accomplish what they're trying to do without potentially infringing on your IP.

Yeah, there's actually -- I think, if you're looking back three or four or five years, we've always thought the epigenetics was very important. And there was a lot of money spent in our name companies. But I'm sure you know the more looking for DNA alone that was the feeling a very strong feeling from them, that they could get there. Our team has proven to be correct, that it was going to be extremely difficult to find early stage cancers in a wide range of cancers. There's some exceptions, but that's the general rule from DNA alone. And that's now absolutely proven to be the case. So they've gone to several ways. And I can discuss, I guess, but if you want to discuss separately, but on an urgent call [ph] the basic system that started with different ways of methylation [ph], which they also used to sequencing, and that's pretty much all of them, that the big companies in the DNA space. Some have gone for other protein, as well and another has gone for fragment dynamics, which was bought from Bellwether [ph]. What do I think? I think they're very well run companies with great people. I think if you put enough complicated expensive things together, you probably end up getting a good result eventually. But the complexity is multiplied the more things I mean, DNA itself is very complicated and expensive. Methylation [ph] markers using DNA sequencing, not neucleosomes like we do is extremely complicated and expensive. And fragment timing has potential to be very complicated and expensive as well. So we've always been about low cost easy to use tests. None of those methods just to be clear, use the lies of a systems in the blood using nuclear same as the way we do. They're still all sequence based, except the way they're adding proteins on is one of the cases. But that's something which that has to 100% get what we believe 100% get it from us. So we're not we're not particularly worried about the goodwill run companies, I'm sure that have been infringed IP, willy nilly. We have been in discussions with pretty much everyone about how we can add to different platforms. But we believe there is absolutely a solid system and need for a very low cost, easy to use test. We wish them luck on the complicated, expensive tests, they're potentially going to work quite well as you put quite a few complicated things together. But it's a completely different market to what we do. Those tests, I think I can see being a lot of blood many, many thousands of dollars, which will likely having strong efficacy in the U.S. for a very accurate test that will be really struggled worldwide, and it will not be a routine test at any normal use of the word. So, I think they can be quite for everyone. I think the DNA is one way of doing it. They're looking for epigenetic markers through sequencing, which is what they do is another way. I think, as we have, and I think it's certainly proven to be a strong case. Now for us, there is a way of doing it very easily in a local space based on our intellectual property, which I think is very solid. And so I don't know if any of them that are actually infringing our IP now, and I don't really expect them to be necessarily, they are trying to do it through sequencing. And I wish them luck. But I think we can add a huge amount of value ourselves in our IP, and perhaps also add to the test. And we're certainly willing to license to groups. We've been in discussions in different areas. But our main aim has always been to launch our own products, because we think there's incredibly big market and a lot of good can come from using our platform the way we can do.

Okay. Relative to the two initial tests that the two CRC tests that you anticipate launching in Europe. Just for clarification, did you say that those that you expect those will be run on the magnetic beads?

The simplest platform we run on now, which is the research kits. And the lung and colorectal, only one long run colorectal will be run on a simple platform, which is just substrate 100% base, [indiscernible] platform. Everything else now we're developing, we will have on magnetic beads and can believe in essence, that's the strategy going forward. And we've been doing a lot of work on base for a while for the Capture program. And we've also spoken to the big diagnostic companies for a while now. And they're very keen on beads. It's just -- it's still a very low cost platform, but every routine lab auto analyzer does. And we're sticking to [indiscernible] and we’re sticking to low cost, but you can get very good specificity and sensitivity, I mean, analytically on the machines and edit the plug and play. So we are very keen to make sure it's used as widely as possible. So we've been adapting to some open platforms as well as we intend to adapted to the closed platform, so it can be used everywhere. But going forward, a very big part of it will be based in chemiluminescents. And I think that's just makes perfect sense. We didn't do it early on, we've kept with the simple format, just until it was fully optimized on that simple format now that we're very happy, what we've done is fully optimized, we may as well make a jump and really get onto the big machine so that we really can be worldwide very quickly.

Okay. And just one on Nu.Q Vet. I know this is -- it's still kind of early stage. But wonder if you can kind of talk about what your expectations are in terms of the extent of clinical data that you'll need to support regulatory approval? And then beyond that, do you anticipate that you'll need additional clinical data to support commercialization to generate interest in the test?

Yeah. So we're taking on [indiscernible] to tell us that obviously, we're not experienced in event space. But the good news is, it's a lot less onerous numbers wise in human space, to get approval to be used in United States. We’re talking in the hundreds of dogs [ph] not in the 10s of thousands or thousands of humans like we are. So I think it's going to be something which is ongoing, I think it's very adaptable to a wide range of breed, species, as well as beyond cancer there's a lot of diseases, which strongly epigenetic in the nature as well. So we've been thinking through all of that, we’ll make that public once we've decided the first lung tests. But it's something which I think will launch tests and then continue to have a whole range in the veterinary space because it's the neucleosome the epigenetic market is very similar between species as are in a lot of diseases. And the vet space is quite tragically bad. So for what options are available to vets really low. For a couple of reasons, animals obviously can't tell you what's wrong, human proteins don't work in humans -- in animal sorry, quite naturally. And even things like doing a scan can be very difficult for an animal which moves you can't tell it to stay still. So you have to do a lot more work in the vet space. So we very firmly believe and so do our partners in Texas that there is a massive in a very wide range of dose diseases as well as other animals on the platform. So we’re just looking to finish the patents and not the relationship with Texas A&M so they can really help us in rolling this out. And we’re going to be there in October. We should have some news on before that what relationship is. But we’re very-very happy with it. And then we’ll have the news coming through as we finish as we talked about on the patient before learning to human space way which starting with preanalytics to make sure when we run the trials it’d be the conditions are the same or the best optimized for the trials, probably you are looking at a very small number of animals compared to what in the human space. So our expectations to have the products on the market next year in the veterinary space and add a lot to it over the coming years because it’s a very exciting which makes it a multi-billion dollar business.

Okay. It sounds like this could be a huge opportunity for you. I'm just wondering if there is sort of a U.S. PSTF for the veterinarian space similar to the human clinical space.

Actually it’s -- I'm learning. I’ll make that quick summary but I can leave that with we now have a [indiscernible] and have specialists and we’ll have in-house relationships with Texas A&M and then we can talk officially. But it's actually similar that the U.S. FDA will have the FDA regulatory purposes but there is also a range of large centers in California, [indiscernible] and then in Texas an Northeast and Northwest of the United States and Midwest that’s coming at a regional center where the lung comes to then they’re officially approved products. But it’s not anyway near as essentially the human space because we’re very much take care about pulling infringe. But obviously it’s a different system that one which we’re getting to learn with the company, we’re taking on the experienced team member who can really help us get this done. But market potential as you said is actually 2.5 times on dog diagnose cancer here in the United States in humans. And given how much we care for dog, our friends is you can judge a question remark given where low cost test is for something to charge about $5000 to $10,000 more like a DNA test, but we’ll be talking $100 or $200 is very achievable. And it’s something which we’d expect to take off very quickly if we can successfully run the trials and launch the products which were very hopeful for. So yes we’re very excited. We’re taking very seriously and we have a separate team now and we want a different company, because we’re obviously focused here, mainly corporate with the deal on the human space. So taking on team members. We’re also expecting to get some non-derivative funding which we hopefully announced for specifically the vet program over the coming months as well. So it’s all coming together we’re very excited.

All right thanks Cameron.

Thank you.

Thank you. Our next question comes from the line of Alice Nettleton with Edison. Please proceed with your question.

Hello thanks for taking my questions. So I'm wondering about the Veterinary subsidiary is it a wholly owned subsidiary or do you have Texas A&M as a shareholder? Are there any other shareholders in this subsidiary?

Good question. So yeah at the moment it’s wholly-owned. We haven’t finalized the agreements with Texas A&M. But we’re looking to bring them on for some equity as well and we’ll announce all of that once we finalize the deal is finalized. But we would always expect to have a lot of attention of the company is obviously on potential property we’re hoping to fund. And we also expect to get the non-diluted funding which we hope to announce in the coming months. So Texas A&M is very important partner and we expect if the negotiation continue with that to the equity shareholders in the company. But we’d expect to be the government party equity wise until we do anything else in the future but that’s something how we intend to begin because of our intellectual property. But we’re taking it very seriously. They are being very helpful. And we’re very happy to be educating them potentially as shareholders in our subsidiary. But as of now it’s 100% Volition.

Thank you. There are no further questions at this time I would like to turn the call back over to Mr. Reynolds to any closing remarks.

Yeah. I just like to thank you again. It’s very busy time for everyone. I think it’s really-really showing that what we’ve been doing with key in the space. And epigenetics is very-very important and so coming to fruition. And we will have some very exciting months ahead with [indiscernible] we have in so many different areas. And a very strengthened balance sheet we have from the strong support from our shareholders. So thank you very much again. I'm looking forward to updating you again in the coming months. Thank you.

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