VolitionRx Limited

VolitionRx Limited

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Medical - Diagnostics & Research

VolitionRx Limited (VNRX) Q3 2015 Earnings Call Transcript

Published at 2015-11-04 13:11:16
Executives
Scott Powell - Vice President, Investor Relations Cameron Reynolds - Chief Executive Officer David Kratochvil - Chief Financial Officer
Analysts
Bruce Jackson - Lake Street Capital Markets Brian Marckx - Zacks Investment Research Jan Wald - Benchmark Company
Operator
Good day, everyone and welcome to the VolitionRX Limited Third Quarter 2015 Earnings and Business Update Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Scott Powell, Vice President of Investor Relations. Please go ahead, sir.
Scott Powell
Thank you, operator. And welcome everyone to today's earnings conference call for VolitionRX Limited. This call will cover Volition's financial and operating results for the three months ended September 30, 2015 along with the discussion of our key upcoming 2015 and 2016 milestones. Following our prepared remarks, we will open up the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, Chief Executive Officer and Mr. David Kratochvil, Chief Financial Officer of VolitionRX. Before we begin our formal remarks, I'd like to remind everyone that some of the statements on this conference call may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as expects, anticipates, intends, plans, aims, targets, believes, seeks, estimates, optimizing, potential, goal, suggests and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the Company's bodily-fluid-based diagnostic tests, as well as the Company's ability to develop and successfully commercialize such test platforms for early detection of cancer. The Company's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include the Company's failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in the Company's development pipeline or any other diagnostic products the Company might develop. The Company will face fierce competition and the Company's intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change. And other risks identified in the Company's most recent annual report on Form 10-K and quarterly report on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about the Company's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this conference call, and except as required by law, the Company does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances. Nucleosomics or NuQ and Hypergenomics and their respective logos are trademarks and or service marks of VolitionRX Ltd and its subsidiaries. All other trademarks, service marks and trade names referred to on this call are the property of their respective owners. I'd now like to turn the call over to our Chief Executive Officer, Mr. Cameron Reynolds, who will discuss the third quarter of 2015 and our clinical and operational objectives for the remainder of the year. Cameron?
Cameron Reynolds
Thank you, Scott and thank you, everyone for joining VolitionRX's third quarter earnings conference call for 2015. I would like to thank you all very much for taking an interest in the company and it's very exciting time for us. I would like to start just with a brief review of the accounts, they obviously have been published, so you can - file, so you can get the full details online. But the key details, made at the end of the quarter with $6.85 million in cash as oppose to $2.14 million as of December 31, 2014. And you will also notice there were two exercising of warrants post balance sheet, which was not included in the cash of $880,000 which further strengthened our balance sheet. And as you can see from the accounts, we've stayed on target. We've kept the finances very high and focused particularly considering all the list of things, I'm about to go through, we've achieved. I can show you we value every dollar and we spend them as carefully as possible to deliver the results which will hopefully drive the company forward. So our next move to review of important then top two [ph] three and I think we've been making great progress and I think it really occurred to me at our Science Advisory Board meeting last week, which had 17 attendees including the key team members from Volition and several new members we announced a few months ago including Dr. Reis-Filho, who's Experimental Pathologist, at Memorial Sloan Kettering Cancer Center, who is a breast cancer specialist. Dr. Ronald Anderson from Lund University, who we worked with very closely, who is a pancreatic speciality and Stuart Blincko, who now works for Immucor, but in his previous role was a Senior Principal Research Scientist at Abbott Laboratories, they joined our existing SAB members and team to go through the opportunities forward in different councils as well as go through our clinical achievements and was extremely encouraging to see such an [indiscernible] group together, discussing our technology in the best way forward for very, very full day last week. So I'll go through the list of things that we've achieved. I think it's a very, very impressive list. I'll start with the Danish work. We released the interim data from the 4,800 retrospective colorectal study with Hvidovre hospital in Copenhagen as well as with six collaborating other hospitals, just to remind you this is a double blinded randomized and independent trial. With truly world-class collaborator. We very much like Denmark because of their thoroughness, their professionalism and the collaborator we worked with Dr. Nielsen [ph], who has been a fantastic collaborator and being in Denmark, you have a full electronic database of everything who're citizen. So it's a fantastic trial and one which is being very useful to us. So the results as announced, we detected 81% of the cancers and very importantly, we detected equally well for both early and late-stage cancers. As I'm sure, you're all aware early stage cancer is the key and we're very encouraged that our assays, were detecting very well early cancers. And on that continuum, we also detected 67% of high risk at adenomas, which are the precancerous and they're most likely to become cancerous. The best way looking at this is, if you can find them and remove them. You get ahead of the curve, most adenoma, that the polyps do not become cancer but it's almost fair to say every single cancer stuff is a polyp. So to be detecting that many of them is very, very encouraging and we'll continue to doing more work to see how early we can get the cancers, even in the precancer. So these results demonstrate the new two test potential to detect cancers over the complete spectrum of development from adenoma or a polyp to early through late-stage cancers. A function of this trial is to best optimize the competition of a panel of four to six of our biomarker assays that will form the basis of the test that we fill commercially. The interim data, with the panel of four of our biomarker assays from the nine assays, which we ran in this population of 4,800 up until the announcements. And we're working on 11 more biomarker assays through the same population to be released in the first half of this coming year in 2016. These final results will allow us hopefully to find a final panel to launch in Europe, with the most accurate rates we can for the detection of early and late-stage cancer, as well as polyps. So that was key milestone number one. Key milestone number two, was the granting of our first US patent, which was for the detection of histone modification in cell-free nucleosomes in the US. Patents, as you're probably aware are very important to protect shareholder value and the large amount of effort everyone is putting. I would like to take this opportunity to congratulate Dr. Micallef on his wonderful job as Chief Scientific Officer in implementing this whole three patents, which he has. This patents is one of the most important key pieces of IP the company has. It's a broad reaching, wholly-owned and royalty-free patent that expires in mid-2029. It relates to the detection of epigenetic changes that affects chromosome structures and counts them, [indiscernible] of our single test using a single-drop of blood. The patent is already issued in Europe and this was the US patent. We expect more patents to be granted now in the coming quarters as our IP strategy continues to develop and strengthen. We've come across no competing or even similar IP, which we believe gives us the very large freedom to operate and patent protection for our investors and stakeholders. The third very, very key milestone in this quarter was the granting of our first CE Mark for the detection of colorectal cancer. And I would like to thank the entire Belgium team and Dr. Micallef for their great work in bringing this key milestone to fruition. What does this mean practically? It means, we can now sell this biomarker assay clinically in Europe. Which is 28 members' states as well as a few smaller ones and bigger ones, Switzerland, Turkey, Iceland and Norway and Liechtenstein? With a total population nearly 600 million people and more importantly 150 million of screening age, typically those between 50 and 75. We expect to have additional CE Marks on further biomarker assays and to launch the panel for CE Mark phase for clinical use in Europe and the entire panel during 2016. The next very key milestone, this last quarter was our first publication. The publication offered primarily by Lund University as Dr. Anderson's team another key collaborator and he'll become more important to us, as we continue to expand our pancreatic work in July during larger trials. And it was published in a journal called Clinical Epigenetics last month. This is yet another key milestone achieved last quarter and a very big validation of what we do. It was offered by a world class team from Lund University, who are experts in pancreatic cancer and it announced that, when it's added to another traditional biomarker CA19-9 to four of our biomarkers increased sensitivity meaning percentage of cancers from 84 to 92, that was even better than we had previously announced about a year ago. And this was the first peer reviewed validation of VolitionRX's panel approach to diagnostic test development. I'd like to thank again, the entire team and Dr. Anderson in particular. Also we had more results in pancreatic cancer from our second preliminary study. Which included 20 pancreatic patients and used two assay biomarker panel plus another traditional biomarker CEA? Just for the background, what trial was this. This was 20 cancers in the 4,800 person trial and there were 20 pancreatic cancers in the colorectal trial just as another coincidence, but in 4,800 people there are obviously going to be some people with pancreatic cancer of that age. And there were 20 of them, which we detected 19, which is also incredibly encouraging that, we have something which perhaps we will, trial them, largely trials with the aim of launching. This will make pancreatic by far the most likely candidate for our second product launch, right behind colorectal, given the results of over 90% detection in these two smaller trials and leads us to very actively be seeking now larger trials, which we hope to announce in the coming quarter or two. And also another very key milestone, we appointed this quarter. We appointed David Kratochvil as a full time US-based CFO for Volition to broad our growing company, enhance our executive team and lead the company financial strategy as we move into commercialization of our NuQ test. David brings more than 28 years of broad financial sector experience and leadership to his role in VolitionRX and I think it was very much time, we had a US-based and experience CFO given our listing on New York Stock Exchange as well as the need now for a, very good ongoing projections as well as at some stage guidance once we get into the product ranges, so that we can have very, very robust financial statements and forward-looking statements so far as income in the coming years, as we rollout products in different companies with the aim of doing all of that. So David will be very keen on that and I'm very happy to have him on our team. So as you can see, we had yet another very, very busy quarter and we expect the following quarters to be equally busy, if not more. The team are working very well together and the prices is all gaining speed as we get larger and larger trials completed in different cancers. Just a brief summary, of what we would expect to see in the next in like this year in early 2016. As I've discussed further CE Marks on our additional CRP assays. With a full panel and European launch next year. And additional patents granted in the United States and elsewhere. As we continue to protect shareholder value, we expect to announce one or more last clinical trials in pancreatic cancer, starting November [ph] and we expect results from ongoing loan and prostate trials soon. Perhaps this quarter or early next quarter the 1 and perhaps two or three of these results in the next three quarters. We've also done a lot of work coming through from other Danish trials. We have the 800 person adenoma study, which would expect results in the next few quarter as well as the first tranche from the very large perspective population from Denmark of the 14,000 patients. The first batch of 2,500 or 5,000 in the next quarter or two. Also, we hope to develop our EU commercialization strategy further including upcoming milestones and timelines for European market access and sales of NuQ for CRC. As we continue to broaden our strategy and implement the implementation of our test in Europe. We also aim to make a small movement towards US commercialization strategy including with the FDA and affirm CLIA lab strategy. For background, we think our Danish trials are very large and world class and being about 18,800 patients. In total including, we had normal [ph] study 19,600 but we do expect to need to do some US work as well for the FDA. So we plan to initiate a bridging US FDA-endorsed trial with our ongoing large trials in Europe, which will be designed to provide the clinical data. In the patient population rather than the representative of US ethnicity, which means basically similar ethnic diversity to The United States to support a PMA submission for the potential FDA approval of our tests, for the early detection of colorectal cancer. In parallel to the FDA. We aim to license our Nucleosomics biomarker panels in the United States to CLIA labs for development as a lab developed test in 2016 and provide VolitionRX with early revenue, well preceding with the FDA process. In conclusion, we absolutely believe that our blood and other bodily-fluids offer the best platform through which to screen for cancer because our test are non-invasive, convenient and have the opportunity for high compliance versus other complicated unpleasant and or invasive test. Which often also require separate doctor visits and or advance reparatory [ph] work such as colonoscopy, XRAY or biopsy. Blood test also tend to be quick and as required just a fraction of the drop of blood, which will allow our NuQ test to be administered during regular screen blood draws and tested on the commonly used ELISA platform. Our blood tests for variety of cancers are proving to be accurate, cost effective, convenient and rapid throughput with the ability to detect early stage cancers which is still operable, thereby giving much better patient outcomes. We are very excited about Volition's current status clinically, commercially and financially and we look for delivering on these numerous milestones through remainder of 2015 and 2016. As I believe, we have done very well in the past four years. We also have an active upcoming investor relations and market awareness calendar and will be announcing our participation in several conferences soon. Thank you all very much for investing in Volition and joining our third quarter earnings call. We'd like to now open up for any questions and I'd like to thank you all for taking interest as it [indiscernible] start. We certainly wouldn't be where we today without our team members, our collaborators and all of you for taking interest in Volition. Thank you.
Operator
Thank you. [Operator Instructions] and we will take our first question today from Bruce Jackson with Lake Street Capital Markets.
Bruce Jackson
So my first question is around the colorectal cancer trial. When you put out the press release about the pancreatic testing done on the colon cancer patient population at Hvidovre. You mentioned that, you ran the test with CEA, in addition to some of the Nucleosomic test, is that something that you're contemplating for the final colorectal cancer testing panel for inclusion?
Cameron Reynolds
Yes, so I answer one at a time or do you other questions or you should have several questions.
Bruce Jackson
Okay, one follow-up.
Cameron Reynolds
Okay, I'll answer. Yes, I think our tests have been performing very well. But in pretty much every cancer, there is an existing biomarkers that haven't quite made it but does provide some good discrimination. I think you probably familiar with them, if you're scientifically minded like yourself Bruce, but things which are very much off patent and very low cost. So similarly in our test, so far as they're ELISA-based, very easy to run, very low cost. Obviously we have very strong IP, we feel strong IP. The one which we, we're now using just because it's very simple to do, ones in different cancers in pancreatic CA 19-9, CEA the PSA, we're looking in our prostate trials as well because ultimately, if another test is low cost and gives us a little extra discrimination then I think it's a very wise thing to use and ultimately, I think clinicians are quite naturally are quite conservative. So they often feel more comfortable, if you're doing in conjunction with the test, which they currently administer now. Now I'm sure you're also aware that, there are no blood test in common screening use except for the PSA for prostate. So none of these have ever really made it by themselves, but they're looking for quite different things to us typically. So we think and we've been advised actually it was a strong point at the Science Advisory Board meeting last week, they said clinically it's a very good idea to, if you can use some of these very low cost additions to your panels, then certainly use them particularly that does give you a little, which these both CEA and CA 19-9 have done in different trials. So I think it's a very good strategy and is one which will be - where there is a very simple low cost biomarker that hasn't quite made itself, where we can co-opt it without anyone else's IP, we're certainly using them.
Bruce Jackson
Okay, that's great. Next question is, can you just kind of tell us in a little bit more detail, how things might unfold in 2016. So you're going to have publication of your or you're going to have release of your trial results from Hvidovre study, then you're going to set the panel that you're going to go-to market with. How long do you think, those things might take in and from the time that we get the data, to the time that you have a commercialized test available.
Cameron Reynolds
Yes, very good question, Bruce. Basically, we aim to have the panel. Certainly this panel finalized by around middle of the year. But as I'm sure, you remember there are thousands of potential biomarkers under our IP, which is very unique for a company to have this much richness of options, but we decided, when we have a panel as good enough to launch, we will launch it, then while we continue to develop other biomarkers, which we can do very easily on our panel because we have such a small amount of blood [indiscernible] trials, but we aim to have it ready then launch next year. Now that is normally, year one you have 10 million units in sales. Obviously it takes time to ramp up sales and launch in Europe. But we aim to launch next year and then spend a good part of 2017 gaining traction. As we discussed before, we're looking to launch in a couple of countries probably two or three in Europe. There are 29 EU countries now and a lot of them do not have screening programs and they are all supposed to, but we're a small company and any one country is very important given our small size in the company and what we can do, launching in a couple of countries is enough work to start with. And then we'd rollout continually more countries, if it continues to go well in 18, 19 and 20. But the short answer is, the panel is ready to launch with CE Mark each individually assay will CE Mark the panel. The volumes or production we're talking now are externally manufactured in a facility that can produce more than that, for us there is no scaling up issues from that technical side. The main thing is [indiscernible] marketing, but in Europe it's not the same as the US, where you're selling to hundreds of thousands of doctors. You ultimately, on this natural screening programs you'll be selling to the one group, the government program as a big group. So it's a different marketing operation that to what it is in US, but we aim to start that process next year and start to get traction in 2017.
Bruce Jackson
Okay, great. Thanks for taking my questions.
Cameron Reynolds
Thank you, Bruce. Have a good day.
Operator
And we will take our next question from Brian Marckx with Zacks Investment Research
Brian Marckx
Just the first quick one and the financials. It looks like, R&D jumped quite a bit based on the purchase of antibodies and other test related supplies and ingredients. Can you give me a little kind of I guess sort of forecast whether R&D is expected to stay sort of at these levels or is this kind of just a bulk purchase that will I guess be used for the remainder of the big studies that you've got there in Denmark.
Cameron Reynolds
Yes, thanks Brian. Basically, we're stuck to our financial projections and there were some big purchases as our IPO was in Q1. We upscale which I described two quarters ago I think, to much larger production facility energy say many more antibodies. So a lot of that costs are one-offs and lot of them are, some of them are continuing. When - we have about 10 trials underway including the ones I've mentioned. So there are continuing cost to which our, while they're bit lumpy but you know month-by-month. But we've burning, if you sort of harmonize it over the period about $750,000 a month and it's a little modular. We can spend more less depending on what trials, we want to do. It's not like a lot of companies where you have to spend a huge amount of money, when one trial because it is, what it is. Our trials are very cost effective and kind of modular, we can speed up other or do others or slow them down. But I think, what we're spending now, I would expect it to be roughly what we're doing for the remainder of this year and the first few quarters. Now as you said, we can turn week [ph] down or turn it up depending on what we want to be doing. But, I'd expect to see roughly similar amounts of funding over the next few quarters as we have done on the last three quarters, spending in the last few quarters.
Brian Marckx
Relative to the timing of the release of the full data of the 4,800 retro study and then the prospect of study. It sounds like maybe though that timing has swift by a little bit based on your prepared remarks. Do you expect the 4,800 full data in Q1 now or is that maybe Q2 and on the prospect of study is that, Q1 still?
Cameron Reynolds
Yes, Brian I think we have try to be conservative. I think if you remember the last earnings call, in August. I predicted maybe October, November for interim results and actually turn out to be in September. So it's a little dependence on the [indiscernible], sometimes little early, sometimes little late. I'd expect both of them to be in the first half. Now that, we could be surprised on the early side, like we were last time. As I said in the August earnings call. I predicted sort of by the end of the year and it was early September and sometimes we're being little late, but it will sometime in those two quarters. It's hard to say exactly, it's driven a lot by, the process and you have to get some antibody developed and then other process, but broadly in Q1 and Q2, both of those will be completed and really [indiscernible]. There is a lot of other things going on, we're expecting some data from some prostate trials, some lung trial. We expect to announce the big pancreatic trial and further CE Marks, further patents all these things are progressing. So there is plenty of news, but I couldn't give you an exact sort of month or quarter depending on how it goes, but we expect in the first half of the year for both of those.
Brian Marckx
Okay, so the - I think you said nine or 10 assays, additional assays that are being used in the retro study, are all those also being used in the prospective study and do you need the top line data from the prospective study to put together the full initial panel?
Cameron Reynolds
Yes, we're doing all the assays, there's going to be more done in the prospective than the retrospective purely because we have more sample. We've got a lot more sample in the prospective because we got the 4,800 if you remember correctly for free. So there was enough just under around 20 assays biomarker assays or little under, where we're getting a lot more prospectively, so we can do a lot more assays. So we, a lot of that is a data driven. We will launch the panel, when we're happy with the results. Now we announced in September because we were happy with the 81% we had, we're continuing to do more assays in the prospective and the retrospective. So what the final panel looks like could be depending on a bit of both. It just comes down to, that's going to be data driven. But we're very keen to launch. So why I'm not 100% certain, it comes down to the results. If we're getting better results from these new assays, we could launch earlier. If we think, there is some really good ones to go, then we haven't quite completed, we'll complete them before we launch. But the prospective one will become the big trial because not only do we have lot more patience, we also have lot more sample. So we can do, a lot more assays through these. As you remember, there are dozens of biomarkers, which are being shown in different diseases including cancer and there are hundreds, if not thousands the difference biomarkers under IP. So this could be a process, which we can continue to optimize for a long period of time, but I think it's very important when we're very happy with the panel we have and then I think, where we are is a very good start. We're very keen to launch.
Brian Marckx
For the pancreatic cancer, what are your thoughts in terms of, what do you think in terms of study is it, one or two big studies which could support an eventual regulatory submission or do you need to do maybe one or two smaller studies first to kind of flush out more the data?
Cameron Reynolds
Yes, very good question. I think the data we have is been extremely compelling to have two different and totally different populations with over 90%, a detection is really good. I think, a population the ones we're seeking out, I don't believe the regulatory purposes, we'll need to anything besides of the ones we're doing in Denmark in 19,000 - 20,000 patient range simply not needed in pancreatic also because you would not be starting with the population screen, unless you're very, very accurate which we're accurate but not in the next [indiscernible] level to screen every single citizen. So we're looking for trial of about 300 cancer patients and maybe 400 or 500 other controls. We believe that would be enough to get us a regulatory approval in Europe, if it is, that is anyway near as accurate as we've been getting. I think, it would give us a good shot at the US process as well because currently, their diagnostics for pancreatic cancers. I'm sure you're aware of are pretty dot [ph] and the only blood marker is CA 19-9 which we're considering better run in the trials, we've done. So I would see the regulatory process being a considerable easy one to get a product launch but, not necessarily as an ultimate screening test because for everybody because of the [indiscernible] incident, but certainly an important test quite quickly behind the colorectal. And just for order of magnitude of the size of the market. We've done research and there are about 46 million CA 19-9 test performed ever year. 46 million, so it's even for biomarker such as that which is, far from ideal. It's a large market, if you can get it out there as blood test. So we're very excited about the pancreatic. We're actively negotiating some larger trials and I think, we estimate you don't know the regulatory authorities till you really got there. But I would estimate that they would be big enough for product launch and something we're very excited about and we're putting a lot of our energy into.
Brian Marckx
Great, thanks. Cameron.
Cameron Reynolds
Thank you, Brian.
Operator
[Operator Instructions] and we'll go next to Jan Wald with Benchmark
Jan Wald
Good morning, Cameron and congratulations on the milestone that you've achieved.
Cameron Reynolds
Thank you.
Jan Wald
I guess, a bunch of my questions have been asked. But I guess, maybe a little bit more on the prospective trial for colorectal cancer that's a large trial. You're going to get a lot of data from that, how are you going to use that data except as a mechanism to improve the aspects, is that going to be part of a clinical, is that going to be part of a submission perhaps, part of the FDA submission or what?
Cameron Reynolds
Yes, that's a very good question. I think a trial of that size has to form a part of your submission if you've done 14,000 patients and if the results are as good as we hope, I think it will form a part of it. Now what the FDA will require exactly, we're in the process of working through those thoughts now, as we talked about. I think, they'll want a US ethnic population mixed trial as well. But the 14,000 if you look at what the FDA's have discussed in other companies in the recent past, Preventive Services Task Force. They really are comparing to FIT, the other sequel test and this is essentially what this trial is. There is 8,000 FIT positives and 6,000 FIT negatives. FIT is the fecal test used in the majority of the world. And what this - so we'll have direct results comparing ourselves to the most widely test used in the world by far, with the fecal immune test. Direct head-to-head in 14,000 patients. So it will give us a tremendous guide, well compared to colonoscopy as well. So it will be a mountain of data, with a very large amount of sample size, so we can do a lot of our biomarkers in this population and it will give us a direct head-to-head with colonoscopy and the FIT test, which is the overwhelming, the dominant test currently used worldwide, not in the US as much. Colonoscopy is a obviously a very important part, but worldwide the FIT is the key test. And if you look at lot of the recommendations from the US groups. They do compare companies to the FIT, a lot. So it will give a very, very good information on that and the 6,000 FIT negatives are about as close to an ideal control group, as you're able to get. We estimate there will be less than 12 cancers in that 6,000 colorectal cancers. So it will be a very, very interesting trial. Not only running all of our biomarkers that we have through a large population and lot more of the biomarkers. Also being Denmark, we have a lot of data points on these patients for the other co-morbidities, [indiscernible] the other cancers, it's going to be a very, very exciting trial. And as we've talked about before, we have the first large amount of sample, the 2,500 patients we're running the assays now, we've run quite a few through these population and we'll continue to run them through with the aim of releasing the data in the first half of next year. But I think it's a very exciting trial, the Danes have been fantastic collaborators and we're really eager to see the results. But as I've discussed there is probably other work we need to do for US FDA. I can't say to speak, to exactly what they will want but, we are preparing a submission and a case to what will be in there, but you have to think 18,800 patients between the two trials and 19,600 patients. If you include, we had another trial, would have to be at least a strong part of the submission. If it is good compelling data.
Jan Wald
So Cameron, just so I've a clear understanding. The assays you're using, there is no way to compare the two trial, the 4,800 patient trial and the 14,000 patient trial because you're trying different assays and different things in both trials. And you're going to come out with a panel, as result of both of those trials but there is going to be no way to, there is no comparison between those two.
Cameron Reynolds
There is a comparison, we intent. We haven't run the same ones. A lot of the ones, we have run are the same, some are not. But the aim is, to certainly have run all the biomarkers through the large perspective that we did for the large retrospective. It's just we haven't done, finished that yet because there were different ones, doing in different times. But to be clear, when we finish the 18, 21s we're doing in this 4,800. We will run them all through the prospective as well. So we're about to see slightly perhaps similar results perhaps probably a different one, we're not sure between the two populations. And the most interesting thing I think from our point of view is, the symptomatic population doesn't have any true healthy because they're all people who had a colonoscopy for a reason. So that typically you have to have something wrong with you either losing weight or bleeding. Those kind of things, so you're not truly healthy. The 6,000 of the FIT negatives in the prospective trial will be the first time we've had a really good control of healthy as you can in this kind of population. So for all those reasons, I think it will become be important part and they will tell us very interesting things, if there are any differences between the symptomatic at the screening population, we'll know. So I think there will be something quite a lot gain from competitive data from both those trials.
Jan Wald
Okay and I guess, my last question is, you mentioned the CLIO strategy. Is there any more detail you can give us on where you are in that process?
Cameron Reynolds
Yes, we've been actively seeking partners for those listeners, who're not familiar with the US system, you can license to a license laboratory in the US to market their versions of your tests and we're in active discussions with several groups, but nothing more I can announce right now. But our aim has been and still is, to launch in The United States in the CLIA lab in 2016, as licensed to allowed which launches as a lab developed test. But I know there is nothing more announce, just that we're in active discussions with a couple of groups and we think we can stick to that timeframe.
Jan Wald
Okay, thank you very much and again congratulations on the quarter.
Cameron Reynolds
Thank you for your questions.
Operator
[Operator Instructions] and gentlemen, it appears we have no further questions. I'll turn the call back to you for any additional or closing remarks.
Cameron Reynolds
No closing remarks, thank you all very much for your time and interest and I assure you, this quarter as the other quarters. We'll be working very hard to deliver on the numerous milestones as we have done for the past, I guess how many quarters past 10 or 15 quarters. Thank you very much for your interest in Volition and I look forward to updating you again at the next quarter.
Operator
Thank you and that does conclude today's conference call. Thank you for your participation.