VolitionRx Limited (VNRX) Q2 2017 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limited’s Second Quarter 2017 Earnings Conference Call. During today’s presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be opened for questions. [Operator Instructions] This conference is being recorded today, Thursday, August 10, 2017. I’d now like to turn the conference over to Mr. Scott Powell, Executive Vice President of VolitionRx Limited. Please go ahead, sir.

Thank you, and welcome everyone to today’s earnings conference call for VolitionRx Limited. This call will cover Volition’s financial and operating results for the second quarter of 2017, which ended June 30, 2017, along with a discussion of our recent activities and key upcoming 2017 milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, President and Chief Executive Officer; and Mr. David Vanston, Chief Financial Officer. Before we begin, I’d like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs, as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K and other filings with the Securities and Exchange Commission. We do not undertake 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, who will discuss our second quarter 2017 financial results and our clinical and operational objectives for the remainder of 2017. Cameron?

Thank you, Scott, and thank you everyone for joining Volition’s second quarter 2017 earnings conference call. I’d like to thank all of you again for taking an interest in Volition at this important time for us. I'm delighted with the progress we are making on many fronts. As I've always said, our team is extremely important to us. We have welcomed some key hires into the business this year as our team continues to grow stronger. In April, we named David Vanston as our Chief Financial Officer. David is a very dynamic and experienced new hire, who will work with us to implement and comply with the requirements under the Sarbanes-Oxley Act of 2002, as well as to help us transition from a research to revenue company. He joins me on the call today. We've also added several other important members to our research and development team and to our marketing team as we continue to develop new products and market them. In April, we celebrated the grand opening of our new research and development facility based in the Wallonia region of Belgium. This was a giant step forward in terms of our capacity to run both large clinical trials, and also to expand our efforts into other cancers; notably pancreatic, lung and prostate. I'm delighted to say that the large new cutting-edge facility was completed on time and on budget with a lot of support from the local government. This fantastic new home for our research and development is a real testament to our expanded Belgium team headed up by Dr. Gaetan Michel, CEO of Belgian Volition. We believe the U.S. healthcare market to be the most important market in healthcare. Our long-term plan, which we have been executing, was to develop our products in Europe and then transition to the U.S. market. The U.S. side of our organization strengthened further last quarter with the formation of Volition America headed up by our Chief Medical Officer, Dr. Terrell based out of Austin, Texas. We formed this subsidiary to have a dedicated team in the U.S., whose main purpose is FDA trial work and the launching of a range of products in the U.S. over the coming years. We were delighted within the last couple of weeks to announce the signing of an agreement with University of Michigan and the National Cancer Institute and its early detection research network to participate in a very large colorectal cancer clinical study in the US. By way of background, the National Cancer Institute, the NCI, is the leading cancer research organization in the US, and the Early Detection Research Network, the EDRN, is an initiative of the NCI focused on early detection. It is very much the force behind intergovernmental, inter-institutional and public-private collaboration building for the rapid advancement of biomarkers and in early detection science. This study will provide approximately 13,500 asymptomatic screening samples of screening relevant people, who have not previously undergone screening or a diagnostic colonoscopy. The aim of the trial will be to validate Volition's Nu.Q Colorectal Cancer Screening Test, in a large, asymptomatic population for U.S. regulatory purposes. As stated in the release earlier this week, the study collection is expected to take two to three years and will cost Volition America up to $3 million paid in instalments over that period. This is significantly less than most large clinical studies by way of comparison. The exact size of the study of 10,000 subjects cost in the region of $30 million. We are particularly delighted to be working with the University of Michigan, the NCI, and the EDRN, all of whom who have outstanding reputations and who share our aim in improving early diagnosis of cancer. This is exciting news for Volition, and very much advances our efforts in the US; something I am often asked about, and in a cost of no more than $3 million represents exceptional value and opportunity. This huge trial with such renowned American organizations really puts us on the map in the US. We also expanded this quarter into Asia with our first clinical evaluation of the Nu.Q Colorectal Cancer Triage Screening Test underway in Taiwan, and have begun the regulatory process in both Taiwan and Singapore. The latter, once granted will also give us access to nine other South Asian markets. For the quarter ended June 30, 2017, we had a very strong cash position with $16.5 million left in cash and equivalents, compared to $14.5 million as of June 30 of 2016. We have kept very close controls of cost despite the high levels of research and development and marketing activities in a wide range of areas. Yet again, we have completed many milestones on a relatively tight budget to ensure we use our cash carefully. Also on the financial front, I'm delighted to say that our Chairman, as well as several other members of our board and officers of the company, exercised in aggregate of approximately $400,000 in cash warrants in the quarter, providing additional support to our cash position. Milestones for the rest of 2017. Looking ahead to the remainder of 2017, we are focused on our front line screening tests, the triage test, and the asymptomatic diagnostic test for colorectal cancer, not only on European samples, but also now including an Asian study, and of course, our large US study. We anticipate announcing further data later in the year as we continue to make strong progress. From a funding point of view, we hope to obtain further grant and soft funding connected to the Wallonia region in Belgium, a very strong ally and supporter of Belgium Volition. I also anticipate we will file and obtain more key patents in several countries, including the US as well as continue to expand our intellectual property portfolio and enhance shareholder value. I am very proud of our teams’ accomplishments in the first half of 2017. I look forward to achieving additional milestones in the second half of this year. Thank you all very much for your interest in Volition and for joining our second quarter 2017 earnings conference call today at this key time for our company. We’d now like to open the call to take questions. Operator?

Thank you. [Operator Instructions] Our first question today is coming from Bruce Jackson from Lake Street Capital Markets. Please proceed with your question.

Hi, good morning, and thanks for taking my questions.

Thanks Bruce.

With the rest of the pipeline, can you give just a brief run through the lung and the pancreatic, and then also the [study]; just let us know where all of that is right now?

Absolutely. Given the large amount of space we now have in the expanded team, we can do a lot more than just what we have been talking about in the colorectal space. So as we have talked about a lot, we have had active trials going in pancreatic, in prostate, and we have been looking to get started again in lung as well as the other cancers. So, our top priority has absolutely been the frontline test and the triage test, which I think I will get to. But as far as the other cancers, this new facility has really allowed us to get to that restarted again because of the extra space. So we haven't made announcements on those, so I won't give you more information than I really should. But we have had more data, particularly on one of the cancers, which we will be announcing in due course. And we will be doing at least one of the other cancers starting up some more work on it later this year. So I think the message here is very clear. We are a company with a very broad range of intellectual property. We have a huge amount of trial work underway. Now that we have this very large low-cost facility and the massive trials in Europe and US, and now we are hoping to sign up a range in Asia. We can be in a very unique position to launch not only our frontline colorectal products, but also a range of other cancers in a lot of different areas, and our strategy always will be to do large trials in as many places as we can, and we can do that with such a small amount of money because our tests have very low costs, and we have had some amazing partnerships throughout the world. The trials you mentioned and a lot of others. The trials you mentioned with the German screening group, DKFZ, for the pancreatic. Also our Danish partners are world renowned. Now the NCI in the US is as good as they get in the groups they are working at EDRN, and I think the trials we are organizing in Asia will also be world beating as well. So over the coming months and then through next year, expect to see quite a lot of data coming through from not only the big ones, the colorectal space, but also the other trials.

Okay, and then, speaking of the triage test, so you have got two things there that are important. With the test three configuration can you tell us what still needs to be done with that project, and then can you also give us a few more details on the Danish implementation study?

Yes, just a reminder for those on the call that the pathway design study is a study that goes through the very practical questions of physically implementing a triage test and as I am sure you will remember, every European screening program has colonoscopy issues meaning that anyone that gets anywhere near the level of compliance they need to they need a test to better triage if you are FIT positive, if you have blood in your stool who needs a colonoscopy. So all the information I have is the pathway design study is progressing well. It is mid-August. So I don't have any specific updates. The last we heard it was progressing very well and we expect to get some updates and data from that, hopefully the final data from that soon. I don't know exactly when. As I said I can't be very specific. It is mid-August in Europe, but everything I have heard it is proceeding as we planned. And on the [indiscernible], at this time we are doing a lot of background work as we discussed, which is hand-in-hand with our frontline work for the frontline screening test, and we expect to have a lot more information on that soon, but nothing specific in this update, but it is all progressing as we expected.

Okay. That's it from me. I will hop back in queue. Thank you.

Thank you.

Thank you. Our next question today is coming from Yi Chen from Rodman & Renshaw. Please proceed with your question.

Hi, there. This is [indiscernible] Yi. I just have a couple of questions for you guys. For the 13,500 samples being collected, is that doing a blood check-up or is there specific blood draws that you are getting?

The full details of the protocol are probably actually best – I am not the Chief Medical Officer, but Jason can give a full update. But they are all asymptomatic. They are collected by the best institutions that you could possibly imagine in the US. They haven't made that complete list. I have seen it. But it is an extremely impressive group of Universities and hospitals. So I think it is a protocol document that obviously is incredibly long. I think it was about 100 pages or more. So it is an incredibly well-run study from everything I have noticed. And its primary aim is to give the best that we possibly can in the way that we can. So, specific questions as to the protocol of the trial. It will be made public. We are very happy with it and our chief medical officer who is not on the call today is probably the best person to – I don't want to make a mistake on such a public forum. But it is an extremely good trial. It is costing us very, very little and it is good as we possibly could hope for. NCI has 69 centers throughout the US, and there are about 10 centers collecting the samples. But it is a very well thought out protocol.

Okay, and is 13,500 going to be sufficient for FDA clearance, or will that be through the PMA or 510k pathway?

Good question. It is a PMA pathway. It would be – it is asymptomatic unless you are doing it as a 510k, which we are not planning to do. It is not replacing something existing. It will be a PMA, and the exact population for their trial which I think – to my knowledge is the biggest one that has ever been done before. For this purpose in this cancer it was 10,000 patients or thereabouts. And from memory HyperGenomics was between 2000 and 3000 for their approval. So 13,500 would be I think by far the biggest population ever done at by far the lowest cost with a fantastic organization, or group of organizations. But from every level I think we are extremely happy with this, and really as I said in the outline that really puts us on the map because now we have a very plausible timeline for a US product in the asymptomatic market, which is the most important market there is, and if you look at the American Cancer Society, for example, their very public aim is to have 80% of Americans screened. It doesn't sound very high, but currently it is only 58% in 2013, the latest figures I saw. So if you can get to 80% screening you save a couple of hundred thousand lives by 2030, which is obviously a fantastic outcome for everybody. But I think the only way to get there is through a blood test. No country in the world despite how much they have tried even with well-organized national systems like in the Nordic countries get much above 60%, 65% compliance with the FIT test or with a colonoscopy. So I think anyone who has looked at this carefully the only way to do it is through a low-cost blood test, which is easy to run, which is run in a normal clinical procedure and that is I think where – exactly what we are doing. So, I think we can be an incredibly important part of the American screening population when we launch it assuming that all goes the way we expect and this trial really puts us on the map for that to really help the Americans get the level of compliance, which they really, really should be getting because as they say the best test is the one you actually do. And at the moment there is up to 30 million Americans who are not doing colonoscopies or any type of fecal testing. Now there are other companies in the colonoscopy and the fecal testing area trying to meet that, but there is absolutely no way I can ever say that is possible without a blood test getting to the – even to 80%, which is I think is still probably lower than you want to be. Compliance with a blood test such as ours are close to 100% of people who take blood test. So it is really the only answer we think, and that is why we are very keen on the US market and as keen to get our product on the market as soon as we can.

Great. Thank you so much. That was very thorough. We look forward to following your progress.

Thank you.

[Operator Instructions] Our next question today is coming from Brian Marckx from Zacks Investment Research. Please proceed with your question.

Good morning guys. Cameron, if we talk about the revalidation of triage again, do you expect when that is complete you will be publicly announcing the updated specificity and sensitivity data?

Yes, when we finish that work and the pathway design study, when it is all completed we will make a full announcement as to all of that absolutely.

Okay, and just for clarity, you do expect to have to get re-CE Mark the panel, is that right?

Yes, I think at the very least we have to update the CE Mark we currently have. It is for the same areas, but the minimum would be an updated CE Mark, which doesn't have to take more than – a small number of months, one or two months, but even a new one would take about three months. But yes, we have to do a minimum of an updated one.

Okay. So how does the revalidation of triage in Europe, does that impact the progress or the work that you can do with your Asian studies in validating the biomarkers over there, and making progress on the regulatory front over there?

Yes, I think ultimately we want to make sure we have the very best test we can. We could have proceeded with – the headline results we had were excellent, but we are just trying to make sure with what we have – what we are we can do the very, very best we can because we talked about with everything – every percent saves a huge amount of lives. So, yes, we want the same product in Europe and Asia. I think we are going to be launching two products. So, we have been working with our colleagues in Asia. We are looking for very good partners there. I believe we have found a group who we can work with very closely who are incredibly well-connected in Asian screening programs. The need for a triage test there is also strong and we have also found out quite naturally that the need for a frontline test there is even larger than in the US or Europe because there is a very large cultural sensitivity in Asia like a lot of countries, also I believe Latin America for any type of colonoscopy or fecal testing – touching a feces is a cultural problem in a lot of countries. So, I am actually very, very bullish about our prospects in Asia. And as discussed we are planning some trials there that don't have to take very long or cost very much, but to prove our tests work in Asian populations there shouldn't be an issue, but it is always good to show that. So I think going forward for all of our tests including the triage, including the frontline, including the other cancers I think Asia is going to be a big part of our future. And I think we are very unique in that. If you look at the other tests, it is very hard to get traction if you are an expensive test or if you need a lot of blood, or if you are a colonoscopy or a fecal test. I think you noticed fecal tests have [explicably] – the big guys in the US haven't gotten any traction at all in Asia. So I think we are very uniquely placed as being the low cost alternative, as being the one in the normal clinical procedure and with good accuracy. So, I'm very hopeful for Asia. I'm working very closely with our very small Asian team, and I think we will have some more information on Asia quite soon. Our team members are attending the Asia-Pacific DDW. You probably know DDW from Chicago. That is happening at the end of September. We are really trying to get in front of key opinion leaders in Asia and the markets there are huge. If you look at China and India, there are obviously a billion people, a lot of which are accessible to such a low-cost test, markets like Japan and Korea are very wealthy and much more liable to eat meat like we are now, so having more and more problems with colorectal cancer. So, yes, I think – but we want to make sure we launch the best test we can. So we are proceeding very much on that basis as I discussed with the triage, and then in the meantime in the last three months, we have got a huge amount of [indiscernible] into the frontline test. And I think Asia will be the very first with Europe that will really start to take off because of the issues we discussed. And in Asia having a CE Mark gets you a long way to being able to sell it commercially and clinically. So for all those reasons, I think it is a very good outcome for us in Asia.

What would you say – wherever you sit today what would you say would be the best case scenario in terms of timelines for launch in Europe and in Asia?

You are talking for the triage or the frontline?

For the triage, right.

I think where we will get an update soon on where we are with the – the big timing issue in Europe is the pathway design study. I will have some good disability on that in early September when the Europeans come back from August. But I think I would expect that to be probably – I thought we could have revenue this year. I think that is probably not going to happen now. I think Q1 is the more likely period. I think whatever we get in Europe; Asia would be quite close behind given our very good partnerships. And as far as the frontline test, I think we absolutely plan to have one on the market next year for Europe and for Asia as a frontline asymptomatic screening test.

Okay. Last one, so in terms of the US clearly the firstline or firstline test is the ultimate goal, but given that that is potentially a few years off can you talk about what your plans are in the meantime to potentially bring a symptomatic test to U.S. maybe through a less robust regulatory pathway like 510(k) or maybe even as a ODT?

Yes, very good question. I think what we have, this I think there's a strong lead for a symptomatic test. It's a much broader age range of people who do have symptoms. When we talk to clinical including our Chief Medical Officer from the U.S. there's a lot of people who present with symptoms that could possibly be colorectal cancer. That would probably not begin in colonoscopy because if someone's low age or other factor. So, I think that's absolutely made. We focused on the frontline test in the lab at the moment. That obviously it's the same method in different combinations. So, we have a population and collected in Denmark, who is symptomatic, we'll focus on that once we've launched the European and Asian version of our frontline asymptomatic test. So, absolutely the path in U.S. starting when we want to do it, when we're ready, once we've launched the European and Asian asymptomatic frontline test, we would look again on doing picking the best symptomatic panel. We have a good sample set for that in Europe. We're looking for good sample set in Asia and a good sample set for the U.S. would be a 510(k) population. So, actually Medical Officer has already done a lot of work on that. It's about $1.2 million to secure that population for a 510(k) in the U.S. would be about 600 or 700 patients. It's a much smaller trial because it’s a lot more cancers in the symptomatic population. So, that the critical number of cancers are achieved all earlier then asymptomatically. So, we'll say we'll like to see on that later this year early next year but that would come to the market a year or two before of frontline screening test. And I do believe there's a strong market for it that we wanted to get our frontline screening test right first and then focus on the asymptomatic. So, meet the bottom line, the answer is we'll make the decision later this year. It’s all set up, we know how much it's going to cost, we know we're going to do it but we want to make sure we get the frontline screening test right first and then we'll focus on the symptomatic test for Europe, the Asia and the U.S. but it would be a 510(k).

Okay. Thanks, Cameron.

Thank you.

Thank you. Our next question is coming from Nathaniel Calloway from Edison. Please proceed with your question.

Hi, guys. I have a couple of questions. My first one is on the U.S. trial. I was wondering if there is any plans and to read off for that trial. If we're going to be able to see the data early?

Yes. I think what we're making sure, the perspective we're collecting and that will take a couple of years. I think given the small number of cancers collected in any prospective trial, then exact to my knowledge I think will answer to only guy. I don’t think we're going to be doing bits and pieces because that could be artificially higher, artificially low on small populations. When you're only talking potentially, if you have 60 cancers, you don’t want to be relating that on 10 cancers, we get kind of binder or you could have this, it could be a 100% or it could be 50% given just to one cancer here or there. so, I think the very practical and logical thing to do is to do it all in one go. But you will have a lot of data from European trials, from Asian trials, we'll be launching the frontline test in Europe and Asia and we're planning on doing next year with very large data. So, you'll know to quite experience certainty what the test does and how well it does. And as we discussed also we want to present a very best sided 58. So, it gives us more time to get the very best output from all the different. We're doing a huge number within a phase in our panels. We want to get the very best with the FDA because you can’t do a version two very quickly. So, you get good readout from all the other trials, we're not a one trial company. We are doing as you perhaps remember, we're doing 30 in-house, 1000 asymptomatic, screening population from the Danish program. We got 90,000 patients from the FIT negative program coming into our operation soon. We're also going to be getting huge trials going in Asia and other parts of the world. So, there'll be a very steady and constant stream of data coming out, which is very unusual, it's very unusual to have a 30 in-house, 1000 person study at all. It's bigger than exact. In fact, I think it's probably bigger than exact and if it's norm is put together, but we're also doing huge populations in other parts of the world, so that we have an undeniable trial of data that really shows what our test does. And also, what we're planning is to do different generations of the test, also uniquely we have a very diverse panel of SA to choose from. We're developing new ones and new IP all the times. So, we absolutely won’t have generation 1, generation 2, generation 3 of our test. And given the small amount of blood needed for the trials, you don’t need to click the trial again and again to have a very large population the run in. So, we see ourselves launching with a good test, we see ourselves getting better and better over time and really making sure that we do the best things by the patients and by the people who have the test about having the very best test we can at the time. And that's a unique opportunity because of the low cost of our test, because the trials cost so little for us and because we have such amazing organizations working with us. Because every single person in this space will tell you, in a candid moment, that the only realize is the blood test. But you never ever get the compliance you need from, you never get to 80% or probably even 70% or probably even 60% or 65% from a combination of fecal testing and colonoscopy, it's just never going to happen. Never happened in any country with the best intent to the world to the most aggressive governments funding everything. So, I think what we owe to everybody out there from my technology is to have massive trials in range of different areas and ranges of countries as quickly as we can and continue to update our product.

Alright, that's really exciting. My other question is a small one. I was wondering if you actually can give us some guidance on the size of financial support that you are expecting from grant from the Walloon Region. If nothing else, just to what the grants have been given to that program in the hand.

Yes. We're very thankful of not only you have the good work in Denmark, even it's amazingly cheap samples as well as the National Cancer Institute in the U.S. as well as the groups we're hoping to work within Asia. Which means the trials will not cost $30 million or $40 million but $3 million or not 30, 40, in the Europe but very small. And we got direct financial assistance from the different regions in Belgium and we are very thankful for their help. What we've got in the past, they typically work in the seven figure range. So, that's what I'd expect to see again. We can’t announce that, we don’t have the exact figures but we haven’t got them exactly yet but we're hopeful that we can get money this very significant I mean when it's in millions of dollar, it's very helpful. But these kind of grants really help us to deliver again and again the best value we can for what we're doing. So, if you look at the cash burn rights, just to no one's actually asked that. So, to discuss in this context, we're still burning less than a $1 million per month, which is unbelievable for what we're doing. That's not going to change very much even with the massive U.S. trials starting. So, for company to be working on three continents, in massive trials in such a new space to deliver such a world changing product is truly remarkable. [Indiscernible] which you probably aware of, inventory $40 million or $50 million a quarter, when to oblige $3 million which is a testament to our teams thrift and the make in corporation we have from the Walloon Region and from our fantastic partners around the world. And they do it not just because who we are, is because what we do in is has ability to really change the way cancer is diagnosed, it has to be a blood test and there's no one else really in the low cost space with an AGC's blood test out there. So, I really thankful that groups will help and it's really allowed us to do what we're doing once amazing low budget.

Alright, that covers my question. Thanks, guys.

Thank you.

Thank you. Our next question today is coming from Raymond Myers from Benchmark. Please proceed with your question.

Thank you, Cameron. How much better sensitivity and specificity are you targeting with the test changes that you're working on right now?

I'm sorry, you're talking to which test, which cancer or which product?

One cancer test that you're, the Triage test.

Oh, the Triage test. Yes, so as we had showed before the headline date, it was around 95% up it's very difficult to get to a 100%. We would like to make it significantly better by a couple of percent. But also you could also increase the cancer and you could also increase the number of colonoscopy saved. So, we're just under 25%. I don’t want to expect later the results coming up will reach through full results, but it would be a gain of a few percent in the cancers and at the very best we'd like to say 5% more colonoscopies, but we're doing the data as well as we can to push that the size we can.

Okay, great. Next, can you discuss the timing and milestones related to the Taiwan and Singapore regulatory process?

Yes. We've been working with our groups in Asia. Typically they take Asian countries once you have a CE Mark, like six to 12 months depending on where you are. China's a exception, to say if it's actually quite a process more akin to the FDA than CE Mark. So, each country's a little different and I'm not next in those countries, so I'll just give you generalities of all over Asia. But the countries we've looked at and we looked at a lot of them including Japan, Taiwan, Korea, South Korea, and Thailand, Singapore, India. They typically involve the government registration process of the CE Mark product, they last up to 12 months depending on the concentrated 12 months. So, then you can sell it to their product market very easily. Those countries, obviously, probably everyone in the countries I mentioned were doing some sort of trial in particularly Japan, Korea, Taiwan, China, India, because there's a huge, is a 100 to 1 billion person market, it's worth spending a few 100,000 or $0.5 million on a trial to answer the question how does it work in an Asian population or that particular Asian population. So, we don’t have to do all those trials. I think the only one we really need to do is in China, which is a few 1000 people. But I think our re-cost is always been it's better to do a trial and spend a year or two arguing that it's going to work. At least that can be done in six months in entire, so they don’t cost a lot, they don’t take a long time, so might just to get them done. So, we're moving forward as quickly as we can as I discussed I think with Bruce, with the Asia was a very good first opportunity. There's a huge culture sensitivity to every other colon diagnostic out there. they're not really fond of colonoscopies or even less than we are and they're even lesser fund than we are. If anything goes touch and feces. So, we see this as a huge opportunity. The Triage test, I think could have been a good point in Asia. But I think the frontline test is a bit, is what they really want is the frontline test. Because they're really crying out for test which can be used, having it adjunct to the FIT test is a good way to get known, get on the market. But when you speak to the key pin related there, they are really hungry for a frontline blood test. Particularly one, and I think we're the only ones have come across out there which is low cost, small amount of blood can be run very easily. You'll have size in way with any coming in that gain. And compliance is a problem in the States, as we talked about it, its 58% and they want 80 but in Asia it's up in the small single figures. And that's all it's ever going to be with a colonoscopy or fecal test. So, I think sometimes you feel like to push you on rate, sometimes people are tugging in the right, want to get your product, and I think it's the latter in Asia. So, we have given all those reasons, so in some area I'm very hopeful.

That's great, really exciting. Can you help me to put some parameters on when you expect to launch that in the first Asian country if it's three to 12 months for registration process? Does that mean that you anticipate your first launch would be sometime toward the end of this year or can you put some parameters around that?

For the Triage test, yes, we'll give a pull up that and where we are with all the different countries. Jasmine's working hard on that and the frontline test, along the lines we talked about in the first week. And now that would be Q1 I guess, but the Asian countries has been some strong interest in the Triage product and extremely sound interest in the frontline product. But sometime following a European country buying it, in Europe, it's probably the countries behind, Denmark would be more like Ireland and then followed to Asia. But and probably not that much far behind for the frontline test, given the work we've done in the last six months on that test. And I think that's the one that really keen on. The Triage test I think can sell, can sell well in a few countries but I think and everything who conclude even so in Asia, they are absolutely desperate for frontline test. So, and I think we're getting close on getting the first if I don’t chose in to run in Asian trials.

Fantastic. And moving on to the Triage test in Europe. I think you mentioned Ireland just now but I was going to ask what other countries beyond Denmark have you been speaking with about the potential for implementing a Triage test?

Yes. The obvious ones in the countries did have, had well informative screening programs. Scotland, Ireland, Holland, France. The other countries, I guess you call it the more the Mediterranean countries, it's patchy and best with the screening programs that you sit because culture sensitivities and unless organization in the Nordic countries, if you know what I mean. So, the obvious markets are the ones that have already got into trouble with the level of colonoscopies along those lines. And that's where we're spending our efforts as we've announced. So, if you go to the bigger countries like France and Ireland, so big countries would have -- it stands apart and the big countries like France where they've got a colorectal screening program. The other ones have got in trouble, the quickest and the highest level because of their screening programs, not having a colonoscopy capacity. And that's where we've focused our reference.

Excellent. Regarding the NCI, the big NCI study that you're embarking on now. Can you give us any sense of the sensitivity and special, the specificity thresholds that you were targeting for FDA clearance supported by that study?

Yes, absolutely so. We've obviously the what you need to get FDA approval is to be the best blood test out there. and we need to be we want to be quite a bit higher than that of course. But what have been FDA approved in the epigenomics trial somewhere in the late 60s to late 70s in sensitivity and specificity. Specificity i believe was those two trials put together, the one Trilato [ph] were 78% and 68%. So, we should be above that. How close we get to what we've done in the pilot studies, it comes down to all the work we're doing now. We've had smaller studies where we've got up to 90% sensitivity and specificity. Now, I don’t think that's where we're going to get in a frontline test, that's is a very hard asked to be 90%. So, for the U.S. frontline test, we'd like to -- we expect to be somewhere in the 80%, somewhere in the 80s, batch wise. And because of the trial has been conducted now, we have a good two years now to get the dates good as we possibly can for the FDA. Now there is that what we expect to launch in, we don’t need to be 90% to get a very successful product in Asia. Then the huge demand is absolutely nothing out there which they can use in any sense in the budget which they're likely to be using. So, our test can be lower than that and I think very successful. But for the U.S. we'd like to be as high as we possibly can in the 80s for both. That's what we'll be working on making sure that we can get close as close as we can repeating the smaller trials that we had.

Alright, thank you. We look forward to that, the 80s would be fantastic.

That would be, yes, thank you.

Thank you. We've reached the end of our question and answer session. I'd turn the floor back over to Cameron for any further or closing comments.

Thank you all for taking part in this call. It's a very exciting time for us, we have a lot going on and will continue to work to get all of our milestones achieved and to get as many products on the market in many countries as we can, as soon as we can. Thank you all for your time.

Thank you. That does conclude today's teleconference, you may disconnect your line at this time. And have a wonderful day. We thank you patients today.