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.

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…

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…

Thank you. [Operator Instructions] and we will take our first question today from Bruce Jackson with Lake Street Capital Markets.

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?

Yes, so I answer one at a time or do you other questions or you should have several questions.

Okay, one follow-up.

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.

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.

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.

Okay, great. Thanks for taking my questions.

Thank you, Bruce. Have a good day.

And we will take our next question from Brian Marckx with Zacks Investment Research

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.

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.

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?

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.

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?

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.

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?

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.

Great, thanks. Cameron.

Thank you, Brian.

[Operator Instructions] and we'll go next to Jan Wald with Benchmark

Good morning, Cameron and congratulations on the milestone that you've achieved.

Thank you.

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?

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…

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.

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.

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?

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.

Okay, thank you very much and again congratulations on the quarter.

Thank you for your questions.

[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.

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.

Thank you and that does conclude today's conference call. Thank you for your participation.