VolitionRx Limited (VNRX) Q1 2019 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRX Limited First Quarter 2019 Earnings Conference Call. [Operator Instructions] This conference is recorded today, May 9, 2019 I would now like to turn the conference 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 first quarter ended March 31, 2019 along with the discussion of our recent activities in key upcoming 2019 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, President and Chief Executive Officer, and Mr. David 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 an 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 would like to thank all of you for again taking in interest in VolitionRX with so much happening. I am absolutely delighted with the progress we have made on so many fronts in 2019, particularly with the work on the basics of our new Nu.Q platform and its expansion into exciting new areas. I appreciate it is not long since our Form 10-K filing and even more recently the Capital Markets Day. But I am very happy to say that we have great momentum and have made progress on many fronts even in just the past few weeks. Firstly, the all-important financials. We closed out the first quarter of 2019 with $16.2 million in cash and cash equivalents versus $13.4 million at year of 2018. And I am delighted to announce today that subsequent to the quarter end we further strengthened our balance sheets with an investor exercising $5 million in aggregate amount of outstanding warrants to purchase shares of our common stock bringing the total cash received by the company upon exercise of warrants by existing shareholders in 2019 to $ 11.7 million showing very strong shareholder support. The proceeds from the most recent warrant exercise were for once previously issued to an investor in our private placement in August of last year. This investor continues to hold warrants with an aggregate exercise price of $3 a share for $4.9 million that expire unless exercised prior to August 10th of 2019. We continue to manage cash extremely carefully, and we believe that we are in a very sound position with regards to the financial runway to achieve our key 2019 milestones and beyond. Secondly, as recent announcement earlier this week, we are delighted to have executed a contract with the National Taiwan University to conduct our first large-scale lung cancer study which will include 1,200 subjects receiving low-dose computed tomography scans including 1,000 with lung cancer, 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 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 patients in the first quarter of next year. Thirdly, continuing on with momentum, I am excited to announce that we are in the process of forming a Texas-based subsidiary which will further develop and commercialize new Nu.Q Vet products and help drive early revenue for the company. We aim to be appointing key personnel and aim to have more news and data to report on Nu.Q Vet in the coming months and quarters. And so to the review of the first quarter. We are very happy to report that the very first data from our newly optimized assays and matrices on our year-end Form 10-K call in March. Just as a reminder, our strategy was to get the assays to the final product grade with all of our improvements including monoclonal antibodies and using recombinant nucleosomes as calibers, something was implausible just a few years ago and now is routine in our assays. In addition to finalizing our assays, we're undertaking a complete review of all blood collection protocols to ensure every aspect to be optimized. We then planned to initially test our product rate assays in smaller trials, and then run larger trials for training and validation of our tests in a wide range of cancers in countries, which is essential for final product development. We hope that improving the assays to the product grade would not only make them more robust, reproducible et cetera, but also hope that cancer detection would be improved as compared to the results of our non-product grade assays. So, I am actually delighted to be able to report the preliminary results in three separate small cohorts with the first completed Nu.Q assays and one item Nu.Q assay that have been run in the first quarter of this year. These are the first part of the preclinical assays on our previously collecting discovery cohorts that are in our freezers. In our lung cancer cohort of 76 subjects a single Nu.Q assay detected lung cancer including stage one cancer, the AUC for this single nuclear Nu.Q assay was 85% cancer versus healthy. I believe that this is the highest individual assay detection rate we have ever achieved. The performance was further improved when used in combination with a 2 assay panel. In the larger secondary confirming lung cancer cohort of 152 subjects, the same Nu.Q assay also detected lung cancer; the AUC for single assay was 79%. This initial proof-of-concept data gave us confidence to move on to larger trials in lung cancer. Hence, the execution of the contract with the National Taiwan University. And finally, in a small colorectal cancer cohort of 123 subjects a single Nu.Q assay detected colorectal cancer with an AUC of 72% in this same cohort 2 assay panel had AUC of 84% also has the detection of colorectal cancer versus healthy. We are delighted that our first finalized product grade assays are performing so well and look forward to reporting data initially from further small-scale clinical studies and subsequently from large-scale clinical studies, in addition to new of our many new assays that are in the development pipeline. We are stepping up the work on these trials and will aim to have a lot more data to report in the coming months and quarters. I am delighted to say that our worldwide patent portfolio of granted patents that protects various aspects of Volition's Nu.Q technology is also growing steadily. This is another key differentiator with our many competitors. We have 20 patent families related to our diagnostic tests with seven patents granted in the United States; seven granted in the European Union and a further 25 granted worldwide. Additionally, we have 15 patent applications in the name of our subsidiaries pending in the United States and such 13 patent applications in the European Union. This portfolio also encompasses of veterinary medicine applications more of which I'll cover later. We intend to continue our development of the Nucleosomics technology and will continue to apply for new patterns for future product developments. Our strategy is to protect the technologies and gain market exclusivity with patents in Europe, United States and in other strategic countries. The patents on the technologies underlying our products should provide broad coverage range products including protection through at least 2031. During 2018 and in this last quarter, we were delighted to present some very encouraging preliminary results from a proof-of-concept study using our Nu.Q diagnostic platform in veterinary medicine. The proof-of-concept study demonstrated that nucleosomes can be detected in dogs and therefore have the potential to differentiate cancer from other conditions in canines. Following the completion of several small-scale studies in dogs, we announced the execution of a non-binding memorandum of understanding with Texas A&M University College of Veterinary Medicine, a leading US veterinary institution to further research and commercialize Nu.Q Vet products. From a commercial point of view, we are extremely excited about the possibility of offering Nu.Q Vet tests to animal owners and veterinarians. They are currently no accurate, simple, affordable cancer screening or diagnostic tests available in veterinary medicine, and yet 25% of dogs will develop cancer at some stage of their life. One very interesting fact is that there is significantly more cancer diagnosis in dogs than are in humans. 4.2 million canine cancers were diagnosed as against compared to 1.7 million humans in the US. The US is currently the largest of veterinary markets in the world and has a clearly defined regulatory pathway by the USDA, requiring fewer and smaller clinical studies than in the FDA process for human diagnostics. This generally allows a much faster route to revenue for veterinary products as compared to the human products. Even the trials need to be in hundreds not thousands of samples. Our preliminary estimate of what a diagnostic test would sale for in the vet markets are approximately equivalent to what we would charge in the human market. We currently expect pricing to be between $100 to $200 per test and we'll believe that the veterinary market is a multi-billionaire opportunity. As such we are taking this opportunity very seriously and are moving forward as quickly as possible with the aim of having the first Nu.Q Vet products in the market in the US in 2020. As previously mentioned we are in the process of forming a Texas-based subsidiary to focus purely on the development and commercialization of Nu.Q vet products and help drive early revenue for the company. With the upcoming appointments of key personnel for our new subsidiary, we aim to have more news and data to report on the Nu.Q in the coming months and quarters. Lastly, as presented at our recent Capital Markets Day, and available to view on our website, key pin leader professor Axel Imhof outlined the progress to date of the Nu.Q capture project. Professor Imhof is a newly appointed member of our Science Advisory Board and our professor for protein and analytics at the Biomedical Center of the Ludwig Maximilian University of Munich, LMU; And the Director of the Proteomics core facility of LMU's Biomedical Center. The Nu.Q capture project leverages the work we have been doing to investigate the use of Nucleosomics to purify or enrich tumor associated nucleosomes. As previously announced, with Nu.Q capture, we have been able to deplete nucleosomes by 70% to 90% using magnetic base in serum and plasma based on initial studies. The next step is to determine the level of discrimination of tumor associated nucleosomes using mass spectrometry and sequencing. This potential breakthrough product aims to enrich tumor associated DNA which in turn will help address the main technology barrier to DNA cancer diagnostics. Nu.Q captures platform-agnostic with the ultimate aim of 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 this potential. And so, to our future milestones, as many of you know, we have concentrated our research efforts to diet on colorectal cancer, which is the most preventable and yet currently least prevented form of cancer and we are very much looking forward to completing our large-scale clinical studies throughout this year and next. In addition to our CRC studies, we are hopeful that our recent proof-of-concept data in lung cancer will be repeated in much larger cohorts starting with 1,200 subject cohort now being collected by National Taiwan University. Lung cancer remains the deadliest of all cancers and there is a high unmet clinical need for either a non-invasive early stage lung cancer detection test or for tests which can improve the specificity of the low-dose CT scan currently used in many markets. 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 is widely accepted that the best way of tackling cancer is for patients to receive an early diagnosis as this improves their chances of surviving cancer. 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 and pancreatic including preliminary data from our first studies in China in addition to the progress updates in Nu.Q Vet and Nu.Q Capture. We are 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. We believe that Nu.Q will provide low-cost routine blood tests allowing doctors to check off an extra box along with other routine blood tests, such as cholesterol, PSA and others during a single visit, and this is the only current credible pathway to take compliance with screening above 80%. We are extremely proud of the accomplishments we have achieved thus far and look forward to what the future holds for Volition. 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 years with our optimized platform. We worked very 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 the busy earnings call season. I am happy to take questions now. Operator?

[Operator Instructions] Our first question comes from Mark Breidenbach of Oppenheimer.

Hey, guys. This is Matt on for Mark. Congrats on the progress and congrats on the progression to project assays. So we were just wondering [Multiple Speakers] you are at a point now where you can give us a timeline for finalizing a product grade panel for the colorectal cancer screening assay assuming that is still the lead indication you are planning on pursuing?

Yes, it's absolutely a very important indication for us. So we've obviously got the very large trials being collected in the US, in Asia and the ones we have been in Europe. So it's incredibly important to us. As we said last time, the first few assays have come through the product grades, we're extremely happy with how they perform. We have got a bunch more in process. We feel we are one or two assays away from getting to the panel we needed to be in the accuracy levels we talked about last time. So in the mid to late 80s in the AUC in a larger trial. So that's going extremely well. I couldn't be happy with how the progress was going with our new assays. There is very strong momentum in a range of them to be done. We do have some preliminary data internally, and we are very happy that some more are coming through and will certainly help in the panel. So, I think as we discussed last time, we are still very hopeful of getting a panel together with a very good level of accuracy this year; based on the current assays we should perform very well. The ones which are coming through, which are looking good and we'll have more later on in the coming months and a bit later this year. So our target has been - have that done this year I think that's absolutely our target. As for primary indication, we're obviously very bullish on the lung side, the lung results have need a less assay to get to the excellent results we've got. So that could actually be through the pack if you will, but, we will know that from the data being collected. We will have some more lung data from the Chinese trials; the three ones going with Fosun later this year as well so that it would give us good indication, if we've been really super speed long to a product earlier than colorectal. But the colorectal is progressing very well, and we are comfortable we can stick to our timelines.

Got it, got it. Okay, that's very helpful, and then let's talk maybe a question on Nu.Q Capture, specifically how you're thinking of positioning that technology, so is this really just a tool to improve CTDNA tests or are you thinking of using Capture as part of like a next-generation approach to improve Nu.Q and also how does that impact your decision to partner or lead self in on your own?

That's a very good. I think initially that the former is what we were thinking, which is, this is a great tool. If we can achieve the goals which were - we think we are getting close to achieving, then it would be a very good licensing opportunity to defeat companies in the DNA space as I am sure - we're - assessing the observation, there were - they're doing a huge amount of work, but as we've developed more of ourselves, I think we can probably do it ourselves as well so far as once you've captured Nucleosomes sequencing is more of a commodity now. So it is possible that we could do something ourselves in this space. It's almost all the same work we do with some external sequencing, so, I think - I think of it both ways. I think it's going to be a licensing opportunity. I think we'll always look to licensing when we can. We are not trying to do everything ourselves, but I think with a small amount of effort in capturing the nucleosomes, and then, sequencing is almost a commodity now from that last level we could do - with - do that with infrastructure we have. But don't forget it's not just a sequencing side, doctors Imhof who spoke very well at our Capital Market Day just a few weeks ago, is very much positive on the prospects of not just sequencing the DNA from the captured nucleosomes by doing mass spectrometry on the nucleosomes. So what that would mean is instead of doing one marker by one marker per panel, you could do a large range of markers on the same nucleosomes, which is incredibly exciting. We are using that initially just the discovery of new markings, obviously, if you know what's on there we know what to look for; But there's certainly a possibility as though it's become - as those machines - the cohorts become getting towards commercial viability, then there could be a whole different level of product capturing the nucleosomes and analyzing a lot of different signals just to reiterate not just doing one assay by one assay. Once you do mass spectrometry you can tell some or all of the hundreds of features on the nucleosomes at the same time. So it's a little more complicated, but it's becoming more much, more routine, but it will give you very, very powerful tools if we get to that stage. So like everything we do, we're agnostic until it's all finished. We are looking for license, we are looking to see if it is possible to do it ourselves, but we have to be what we normally do which is on normally and we're not looking to rapidly expand. We have a massive new team. If we can do it on a sort of business model which is to do very little ourselves and get others to do, then we certainly look at doing it ourselves. But if we do manage to get it to the finishing line, and we are getting closer all the time, it would be a massive breakthrough. So we are very excited.

Our next question comes from Jason McCarthy of Maxim group.

Hey, guys. Thanks for taking the question and congratulations on the progress. Essentially with the --with some of the larger studies coming up, I'd like to see if you could kind of walk us through the workflow from sample collection to actually reporting data, and then which step like collection, analysis would really be the rate limiter for these?

Yes, so that's a very good question. So once we've got the assays, while we focus so much time and effort with our massive facility system, huge amount of effort and time we've spent getting the platform to the starting line, if you will, for all these different trials, gives us tremendous momentum to really get this through the door. So what it means is once the assay is in its final clinical, preclinical stage it can be using all the different trials. So that's been a huge pace for us now. Obviously, we realized about two and a half years ago, we had to do a lot of work to make sure now really of the absolutely first-class quality you really have to be if you are going to revolutionize diagnostics and have it as something that can be used everywhere in the world. So now that work, I wouldn't say it's completed, but certainly the first ones are completed and there's now a system we're putting a lot of assays through that. Once you have that they can be used in a lot of different areas and you can also - one of our trials in Asia, we are looking to shift it and we don't even have to run the trials ourselves, for example in Taiwan, also in China. We are also looking to run some trials in the US in the Vet space. So that's been a very big beginning for us, but then after that it depends on the trial as to the collection takes the time. So as you are aware the trial would continue on its date, has been continued for like a year and a half now. And we have taken up a year and a half to finish. If you look, that's the last colorectal trial EDR co funded by the NCI. The other chances can be a lot quicker. Lung cancer, when you are collecting like a thousand samples 1,200 samples, we will have the first big chunks of those later this year and when you have 500 actual camps and controls, it's a very meaningful study. So it does speed up, but the short answer is the pacing of it up till today has been giving the assays to the really final level, and we are incredibly happy and proud of the work we've done on that. And the platform is very robust now. And now, so, we are running it in the ones which are already in the freezer which can be run quickly and easily to show how well they work; and we are very serious about running very large [old] plated trials in the range of new areas, and those do take time. But, because we've been testing for a while now like in Taiwan, we got a message from Taiwanese colleagues that this is the 3,000 mark in the 7,000 assays and trial been put to test, so we will getting the first pictures of that in the short to medium term as well. So we have thought ahead, we have been planning these trials. The reason we are collecting - while also going on so that we can run them concurrently and not one after the other. So, I think it's been a great strategy for us to do so we could really get the ground running with all the different things we are doing. And it's a really nice kick up in all of this with it - it is also working in the veterinary space, which just shows the tremendous robust system of the platform that we've developed and how many different uses we can have. So, yes, that's the two major pacing given.

Alright. Thank you. And then, actually, I would like to talk a bit about the Nu.Q Vet because this seems like it's the nearest potentially meaningful revenue source. So looking at that market, are there any other vet diagnostic products and other indications that we could look at to get an idea of some of the market dynamics in the space? Or are you guys' kind of pioneers in the vet diagnostic space?

I think a lot of attempts have been made in the vet space because it is a massive need; I think in lot ways the market is as big as the human market potentially given the very high rates of cancer in dogs and their short lives. So we've been looking from the parable as well. We haven't actually found too many mainly because we think we can be very successful and none of them have been because ultimately at the moment dog scan, as you probably work very hard to keep a dog still, you have to [size] them and there's a lot of problems. So there's a massive need for blood products. All the information we have is there's nothing out there at all which is fit for purpose. The vast majority of human proteins do not work in those, which make sense when you think about it, but as the nucleosomes do, so - we've actually done a lot of work on those ourselves. One of the things we're doing with [Indiscernible] they are very excited about the Vet space. I was just down in Texas I think right after the capital market date; I was extremely impressed with the professionalism, the financing of Texas A&M and how keen they are to really work with us to get this across the line. So for all of that we're setting up an office in Texas. We are also setting up a company. It's not going to cost a lot of money; we are getting looking to get subsidies by the local region as well as Texas A&M will help us financially a little bit as well. So that should all get it to the market. So your first proposition - position was basically, would this - could this be the first product? It really could. If you are looking in the dog space of a few hundred samples per trial for lab products or even for a USDA products, we are seeing very good results in dogs as we have in humans. So I think it's very plausible we could have a product or even a few products on the market next year. And because there's a final clinical grade assays, we can mass produce them. There's no - no hold ups in any of those areas, and if we are working cooperatively which we aim to finish off in the next few months with Texas A&M, I think their professionalism and knowledge in this space will really help to drive sales as well. So, yes we are very, very keen about it, and but, I know - looking for things to model against that's actually little - we haven't done anything. But we are also looking to - we are looking to really strengthen the team in Texas with the few key people who can re-analyze the market very carefully as well. So we'll get back to you, I think by next quarter. We could have a better analysis of the market for you as well, but it's a huge.

Our next question comes from Jonas Peciulis - Edison Research.

Hi. Thank you for taking my question. So about the proof-of-concept data that you - and studies that you are doing now with upgraded assay, I guess these are both small-scale studies, but still pretty interesting in a way that you have first looking how these real assays perform. I do recall one slide during your Capital Market Day where you show that you were working on different cancers and potentially care to those release more data batches. Your small-scale studies those Nu.Q that you can guide very precisely on - what are the plans of date release or specific timelines, but any details would be helpful just because like I guess - it's interesting just because you are testing new assay in those study?

Yes, absolutely, I think the key milestones in the data science, there's going to be quite a few in the next few months and quarters. Now the assays are at the final stage for the first view and we've got a bunch more getting close over the summer. We are going to be using them - the big ones those we have quite a few in the freezer, but the big new ones, the three trials from Fosun in China are currently being collected now. So we would expect them in the coming months. Taiwan is a huge amount of collection going on in the colorectal space. So we would expect to have some data on that later this year as well. We've also - expect to have - we are getting more samples in Texas A&M in the next few weeks or months as well. So strongly expect to have data in the veterinary space this year as well, and we do have a range of other ones including the 2017 cancer studies, with Dr. Holdenrieder, as well as range of other ones in the freezer which will also be running. And given a very much strengthened and strong balance sheet, we now have the capital resources to really do all these things with the team. We couldn't do two or three things at the same time before, but now we have over 30 people, 35 people in Belgium in our lab. We now have $21.5 million - $32.12 million on the balance sheet with a capital raise and what was left at the end of the --at the end of March. We could really get all these different things done. So there should be a very large amount of milestones on the data side - on the contract side with - we also obviously we've signed Memorandum of Understanding with Texas A&M and we support them. We also strongly expect to have those final agreements outlined in the next few weeks or months as well. And I think we're getting to the stage where we might start licensing discussions with groups like Fosun in China. The groups there will have data in the next few months - we're looking to see - we're looking to work with local partners. They are very keen to talk to us about licensing our products for markets like China, and potentially other groups in areas like Taiwan. So it should be a very busy few quarters.

Okay. Thank you. Now another this question would be around lung cancer trial in - study in Taiwan. So in lung cancer, obviously low-dose computed tomography is considered as the gold standard but really there has been issues with specificity, so given that it's a large trial and you'll get a lot of insights from such trial and obviously design is important, so what is your just thinking about positioning - what could be the positioning of nucleus test in that and is that's a big limitation? Is this before the computed tomography or after or to be used in conjunction to prove specificity, what are your initial thoughts on that?

I think that's a very good question. We thought about this a bit; The low-dose CT scan is the gold standard, but it's not very good. I think anyone in this place will tell you that. It's got a very high false positive rate and it's not something you want to mess around with people's lungs and needles unless you've got a very good indication that the lump is actually cancerous. So it's a very good question one we are looking at quite carefully and that'll be data-driven, but I think they can definitely be used in both census. It can be used in conjunction with a low-dose CT scan to add better specificity. How that would work if you have a lump in your lung from the scan and you have a very high level of nucleosomes structures would indicate cancer then there is a very high chance you have cancer. So definitely worth than having a needle biopsy and the process. The problem with a low-dose CT scan is that it does pick up most lumps or a very high percentage of lumps on your lung, but if you are a 65 year old smoker, there's a good chance you have a lump in your lung and something else as well. So it's not very specific. It doesn't tell the difference between the two. But the other problems with the low-dose CT scan, as I said it's not ideal, is compliance. A lot of people don't like going through scans for a lot of reasons. I know although it is low dose, they are still getting some problems with radiation. And it's expensive and all those things, so you could also use it before the scan even if it's in conjunction with the scan to give you a jolt to go in to get a scan, and then use the data together, which is also - we'll discuss with our collaborators because the compliance is a bigger problem than specificity. But having said all that, also our data appears to be very strong in lung, and it's the best data we've ever had in any cancer. So we are ultimately looking for a front line tests, but we have thought about it a lot and it's much easy to become part of the current systems and helps the current system over there in the table from day one, which first of all, somebody like us it's kind of ambitious to do, and so, we would aim to work with the current gold standards which is the low-dose CT scan before or after, and while we continue to work on a test which can be standalone as a test to drive you towards a better outcome. But - and we'll have a lot of data on that from the Chinese trials this year, and beginning Q1 next year with a large Taiwanese trials and we are very excited. And that would be a massive product in Asia particularly India and China where the air quality is pollutant and therefore lung cancer is obviously quite prevalent.

Our next question comes from Bruce Jackson of Benchmark company.

Hey, good morning. Just a quick question on the veterinary. So a quick question on the veterinary agreement with Texas A&M; they have a reference lab, I believe, is there a possibility that they could be offering the test as a lab developed test prior to being a USDA approval?

Yes, absolutely. So we've discussed this with [Indiscernible] obviously they're very passionate and not only are they very knowledgeable in the space and very good professional people, but they very much care about the animals in their care. So obviously anything which we show with them works. They'd be very keen to use themselves as well as look to generate revenue externally. So that's the great thing with working with a group that does not only research but also has a large veterinary hospital and schooling there that can be used very much internally and externally for them, and that revenue could - we'll see we need to go through the next phase, but that's - that could be the first revenue we get in it in a serious way and once assuming it continues to go well and they're happy and it works well there - which is a reasonable expectation, I think it could really take off very quickly because they have a fantastic reputation. They are very professional and as you sit - as you are getting to my desk that's the best way of showing how much the other product is they their self. So we are very keen for them to use it and I believe that that would be very good expectation and a very reasonable expectation in the short to medium term to get them using the product.

And then, just real faster one, if you can recap the process for getting a USDA approved test, so what are the key milestones for the submission and the approvals and what's the next step in getting a USDA approval for you?

I'm actually not the expert reviewing all that now; we've set up this guy considering evolution of veterinary. We're doing that this next couple of weeks. We are then going to start it with a few key personnel. Hopefully from the team from Texas A&M, as well as some of our own team to make sure we get the exact pathways lined up. I won't go through the specifics, just in case I make a mistake. I want to be very sure I am accurate, but we do know it is a much shorter process. And talking in the tens or hundreds of patients to get USDA product approved, so it can be done much quicker and that's something which we are looking together a dedicated team in Texas working on that because we're very keen to get the product out and revenue done as quickly as possible. The actual process - we will outline that, so the next few steps in the veterinary space is to set up a subsidiary full of a few key people who can really drive the business modeling, as well as all the questions you have, as well as work with Texas A&M; have a final deal with Texas A&M where we participate in the company together, and then get a lab developed products as you mentioned and then go through the USDA process. But the indications are once the trials have gone through, which is in process now, it can be a 6 to 12 months process to get the USDA products on the market and the lab developed one would be quicker. And we're also expecting a video with the key personnel which are going to be filling up the company. Our subsidiary in Texas Volition veterinary. So we expect to see that by the end of May. It's really picking up momentum; it's all coming together in Texas with the research, with the samples, it's massive market, our intellectual property is fantastic and covers all this space, and with the strengthened balance sheet we have we can do a few things like this and stick to our very, very low burn rate of $1.3 million a month. And we're looking to get some regional support as well to try and help fund this - the whole process. So we expect to sit here a lot more in May and June, and I'll be visiting a couple of times over the next few months as well to make sure we really keep the momentum in the best place.

Our next question comes from Brian Marckx of Zacks Investment Research.

Hi, good morning, Cameron. Is establishment of the Nu.Q subsidiary a prerequisite to moving that program along?

It's sort of a requisite, but I think we are extremely keen to make a small focus group to make sure we deliver product as quickly as we can. We've always spent a lot of time to develop the platform; it's now time to reap the work we've done. So, I think a small dedicated team in Texas close to the facilities; I visited Texas just after the Capital Markets Day and the team there was very, very happy. So I think the subsidiary is the way to do it in right close to where the action is in Texas where it's all going on, and so we can really develop a very focused pathway to revenue in the first products with the fantastic group of Texas A&M. So it's not a prerequisite, we could be running it from here. We could be doing processes, but Volition has grown by being a decentralized multinational. And so far we have a very central strong team in Belgium that does all the research, but we really want to get things done locally and managed locally because it's much quicker and easier to do and much faster. So that's why we're setting up subsidiary and that's why we are doing in Texas A&M. So it's not a prerequisite, but I think it's the best way to go and it really drives - it can really help us get this done as quickly as possible because we really want make sure that rubber hits the road as quickly as possible on the bedside as well as everything else.

Okay, and then on the CRC Triage Test that you had talked about in the past for Europe, is that still considered on your radar for a potential initial commercialization candidate?

Yes, absolutely, so the triage while the product was based - is progressing, obviously there are a lot of collections going on now. The assays are getting to the final stage and the next batch and the first ones are being great. So, and the first results in colorectal have been very, very good. So all the product profile, I think is 100% need for the triage products as I've said on every call, I guess. We would push the product too early - a couple years ago now. We really had to make sure that the process was properly done and we had a very robust platform, and that's where we are now. So, but there's absolutely still a need for triage product in the countries where they were before. None of those problems have been solved. There's still a huge colonoscopy capacity problem. I think there are also similar issues in Taiwan. So we'll be running and looking for triage products potentially in Taiwan, as well as the front line, as well as, symptomatic. So very much - there is still very much need for all of those, it's just we really had to get the work done to make sure we had the right platform to launch those products and that's where we are now. But 100% there is still a need and we're still very serious about all the colorectal products, the triage, the frontline test and also the symptomatic tests, and we expect to have data on them this year as from Taiwan, from the European and from the Chinese samples as well. And that will really do all this. I guess in the colorectal space which is the best product launch first. We have gone to the triage first that could well be the case and it depends on the data, I guess, from the frontline tests which were very helpful. We can get to the levels that we need to launch it with a panel later this year. We'll update on all of that, but we're very much together on all the colorectal processes, but the delay has always been just beginning the platform to the starting line. There has been no change in the market need for these products.

This concludes the question-and-answer session. I would like to turn the conference back over to the presenters for any closing remarks.

Thank you, everyone for taking interest in us at this very important time. I am very, very happy with the momentum we are getting, and the strengthened balance sheet, we will really try to make sure we get these milestones data to door as quickly as possible in the very wide range of areas we are working in. So I am really looking forward to the summer with a lots going on, and we'll do the next quarter in August. Thanks for all your time.

This concludes today's conference call. You may disconnect your lines. Thanks for participating and have a pleasant day.