Good day, and welcome to the VolitionRX Limited Fourth Quarter and Full Year 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.

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 full year ended December 31, 2015 along with the discussion of our key upcoming 2016 and 2017 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 of VolitionRX and Mr. David Kratochvil, Chief Financial Officer. 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 full year 2015 earnings conference call. I'd like to thank you all for taking an interest in VolitionRX, and it's very exciting time for us. 2015 was a tremendous year for VolitionRX with significantly advanced clinical programs in colorectal, pancreatic and lung cancers with full trials showing 90% sensitivity in these cancers. We released interim results from our first large-scale clinical trial, 4,800-subject retrospective colorectal cancer study at Hvidovre Hospital in Denmark from the University of Copenhagen. We took the stage for the expected commercialization of our products -- first products for clinical use in Europe in 2016 with our first CE mark in a single biomarker assay last year. We released numerous datasets that further validate the robustness and accuracy of NuQ technology and Nucleosomics platform. We boasted our intellectual property portfolio with the addition of a number of key patents in the U.S. and around the world. Cash and cash equivalents as of December 31, 2015 totaled $5.9 million, compared with $2.1 million as at December 31, 2014 and $6.9 million as of September 30, 2015. And of course, we listed on the New York Stock Exchange as MKT marked last year as well. Review of important Q4 events, granting of our second U.S. patent entitled methods of detection of nucleosomes adducts. This is a core technology patent covering the methods for measuring nucleosome protein complexes known as adducts. This is wholly owned and royalty free patent that expires in December 2032. It covers the measurement of estrogen receptor adducts and androgen receptor adducts which should be pivotal for detection of breast and prostate disease respectively. We have come across no competing or even similar IP; we believe this lack of competing IP gives us a very large…

Thank you. [Operator Instructions] We will take our first from Jan Wald with Benchmark Company.

Good morning, Cameron and congratulations on the quarter, it looks like you're making good progress. I had a couple of -- I guess two questions. If I look at the clinical trials you're involved with, I can't divide them into three different categories; platform extension like the latest lung trial where you reported algorithm or test link and regulatory for commercials. So those are the three categories. I think the one's I care most about are the commercialization, the regulatory ones. So could you describe which of the trials that you're performing are for regulatory submission and will you are in the process?

Absolutely, thank you Jan, and thanks for your interest in the company. I'll split it into Europe and the rest of the Board in U.S. So if I was Europe, the regulatory trials I'd be seeing up confirmatory trials which are smaller in population, they tend to be 300 to 500 patients, a little bit lack of 510(k) size of trials. So all of our CE marks involve small trials to justify the CE marks. The larger trials in Europe, the 4,800 and the 14,000 patients are all very good for adoption, so once you have the CE mark you're allowed to sell the products. But we're doing these massive trials to convince key opinion leaders and convince doctors that they are very good trials. So if you look at it that way, in Europe CE mark allows you to sell in other places around the world but the large trials drive people to buy them. And then U.S., obviously the prices for now is starting with the FDA along the timelines I outlined and your outlined in the 10-K. And for those we're aiming to do smaller 510(k) trials in symptomatic and high-risk populations in colorectal, lung and pancreatic. So the purely regulatory reasons those and the PMA trial in the colorectal cancer, the one's which I required for the regulatory work. Now I think as I discussed in the 10-K and on the call, we aim to apply for 510(k) for all the cancers and symptomatic and high-risk but for the moment, the only one which will justify a 10,000 screening trial we believe is colorectal in the U.S. I mean we're very serious about getting that as well. I think for the U.S. it's the regulatory side, the 510(k) trials and the PMA. And adopted trial Dr. Trail [ph], we've taken on full-time this year, he has been looking at -- he is a diagnostics expert, he has been looking at CROs in ways of completing our U.S. data for those trials because he strongly believes the quickest way potentially to get them approved is to do a reasonable amount of work in the U.S. So that's what he is working through the plan now and we'll announce the outcomes of those as they are completed and made public.

Okay. Then I guess my second question is, you haven't given guidance for next year in terms of finances but notionally could you talk about what kind of revenues you expect and what SG&A and R&D spends will look like for next year or beyond? Just to give us a sense of the spin rates and where revenues will come in.

Yes, we've been very conservative, and I see if those are in the line. We've been very conservative in the estimates of revenue just because it's always best to be conservative and the NuQ -- your product which we believe is quite revolutionary. It's often -- other we think we will end up probably getting very good revenues, it does take time. So we've been very conservative with minimal revenues in '16 and '17, nothing very meaningful because ultimately, although we think our products are revolutionary, we want to make sure that we're not relying on those revenues to fund the trials. So I think minimum in 2016 and 2017 and then really taking up through 2018, 2019 and 2020. I'm sure I'll see if I can go through that with you perhaps in thoughts off line but ultimately we think 2018, 2019 and 2020 will be when it really begins to take off revenue as what we would expect. And because -- although we expect to have CE mark this year, it certainly takes time to get key opinion leaders and governments in Europe and other places to start buying the product and typically it does take time. Although I think we have a tremendous advantage and other varies in our product, it does take time, so we're trying to be conservative but we aim to have the product this year and begin sales next year but really meaningful sales in the year after that.

Okay. [Cross Talks].

You saw we've raised $9.7 million in February and we still had $5.9 million left at the end of the year so we don't spend a lot of money, it's just over $2 million a quarter although because of some income from once we actually only used just over $1 million this last quarter which is a remarkably small amount of money for a company our size I would think. So we're looking to increase the burn but not as much as -- not that bid would assume, we're doing a bit over $2 million a quarter. I think probably we're getting closer to $3 million a quarter as we go through these trials but it's not going to be a tripling of spending, we don't expect from the next period.

Okay. And my last question is about the 510(k) approach that you described. The 510(k) makes sense as I guess because it's high-risk patients and late stage patients. Could you talk a little bit about the rational for assuming if that's going to work with the FDA. Have you talked with them about it? Have you -- are there other competitors who've done the similar thing?

Yes, I think if you're looking for model you would probably go through a million. So they are varying test. Ultimately we think -- you don't know what the FDA is going to say till you approach them by their process. But an adjunct test makes lot of sense for very cost effective, very easy test to administer. It certainly gives the clinician pretty good information. Now obviously to make the final decision, you need to go -- if it's going to be a full screening test, you need to go through a PMA process most likely, and we are serious about doing that but we've come to the belief there is a potential for very solid market in the meantime, being approved is an adjunct. And if you think about it, tests which we use currently are lot now -- tests like CA 19-9, I've never been through a PMA process in that same manner but quite widely administered for different reasons. So we would see ourselves bringing the product to market for those applications while we do the large screening trial because when you're in last quarter, we spend just over $2 million, not very much revenue becomes very, very meaningful for us. And we think there is a considerable market in the symptomatic population in colorectal and very much though in lung and pancreatic. The high-risk groups are reasonably obvious. In lung, it's high -- it's more in over 55 years old and in pancreatic cancer, although it's not as obvious, it is when you think about it, it's anyone who has stress on the pancreas. So the most obvious people for that would be people like at onset diabetes, you have about eight times more chance of having pancreatic cancer if you've been diagnosed with onset diabetes. So I think there is a very solid market testing those people while we do the large trial -- the PMA trial in colorectal.

Thank you very much. Again, congratulations on the progress.

Thank you very much. It has been a very good year. Thank you.

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

Hi, good morning Cameron.

Good morning.

A follow-up on the U.S. strategy, I think the latest prior to the 510(k) strategy was CLIA lab, is that still in the works? Do you plan on pursuing the CLIA lab route I guess in parallel with 510(k) strategy? And then on the 510(k), it's going to be an adjunct if you could talk about an adjunct to what I guess?

Yes, absolutely. So the CLIA lab, old labs are still on the table until we finalize our strategy and speak to the FDA. I think no one can predict exactly what the FDA will or won't say. So I think we have a very solid case but obviously that's always going to be determined by them. So the CLIA lab route, I think licensing to become a lab developed test is an option or even setting up our own CLIA lab is an option, it's not our third option but it's always an option. So I think we have several different possible past to the market relatively soon, the CLIA lab is one, the 510(k) is the second and in each counter, and then the longer-term route is obviously the PMA. So if you look at as an adjunct, if you take -- probably the easiest way to demonstrate would be -- say for example, lung cancer where currently the guidelines have full of CT scans and those people over 55 -- with Americans over 55 who are heavy smokers is defined by 30 back years of smoking history or more. So the CT scan what I understand, it's quite sensitive, it's not very specific, I know blood tests are proving to be good at both. So we'd see ourselves being adjunct to the current tests as those CT scan in for example, in lung cancer to provide more information. Now I do believe our tests have the potential to replace what is currently used in few different cancers but I think the easiest path to market is to come into the current system and be complementary to what is currently done while you get some good track record in sales in the process, and every single count that has…

So Cameron on the 510(k), are you going to -- you're going to seek indications for every cancer that you're under clinical trials with today, so colorectal, lung, potentially pancreatic?

Yes, exactly right, that was our intention. In high-risk population you're looking -- we estimate in the 500 or 600 patient sample size, when this is symptomatic or high-risk population those sizes are bit more, can be enough cancer patients to make it physically valid. And that's all being determined now and if you look at few thousand dollars per patient, you're looking in the million dollar range, plus or minus for the trial. Now that's still -- we're still in negotiation, that's not finalized but that's the ballpark to what we'd expect to, to need to pay for those trials. So we think it's an incredibly good investment. If the FDA are accepting of it and the trials go well, it's a very good way to launch a product quickly. And as I said, other adjunct products sell very large amounts when their low cost, cost effective blood test which can be easily administered while we do the process of getting our tests better and better and better.

Okay. And then if you could just -- status of some of the studies that are ongoing, I think you had a pilot study in ovarian cancer, the timing for the data on the 27 cancer study. And then pancreatic, I think you had the timing on the size of a bigger pancreatic cancer study I guess.

So pancreatic was to negotiating larger trials, lung we have trials underway. Our prostate, we have several trials underway. The 27 cancer trial, where we're hoping to get some data later this year but it took a bit longer in collection on the healthy cancer patients but as now finished collection and is beginning work on the phase now. So we expect it in the first half of next year. We're expecting to run about 25 assays through that population. So it will be by far the broadest and biggest trial we've done so far as colorectal cancer and number of assays through a population. We're very eagerly awaiting that data. And the colorectal trials, as you know we released the adenoma data and the 430 patient study, and as it was in the press release, we found some new markers which worked very well in the early stage cancers, and particularly in adenoma. So now we're putting that through the 4,800 population to see if it does results borne out in larger population, as well as in the screening population. So we expect to have data in both those trials this year in the colorectal side with the new and the old markets. And as I said, with time we're negotiating pancreatic, we're working on the 27 cancers and we're working on a range of different prostate trials. So yes, it's going to be an exciting year. So sometimes some come a little faster I think, some go little slower, it's like we've got three prostate trials coming, we'd expect data from that reasonably soon. And as you know it's a very important cancer. The pancreatic cancer will be fascinating [ph] for some reasons to see if we can tell between the cancers. And the pancreatic -- we announced as soon we've negotiated the trial assuming we do have.

The two big data studies, the retrospective and prospective colon cancer studies, the timelines have slipped a little bit. And now it sounds like it's going to be a second half 2016 event. Is that -- do you think that that's pretty solid timeline where you will have it?

Absolutely, yes, I think so. We've not so much slipped from the adenoma study, we finished that and concluded the study a little ahead of time and we've identified some very exciting new markets. So we want to -- we only have so much sample in the 4,800. We wanted to wait to make sure we're doing the best by market in that population. So now given the very good results in the 430 patients study on the old and the new biomarkers, we're very confident to be finishing that now. So the team is hard at work on those two large trials. So we decided it was worth waiting to get the best biomarkers we could from the work we finish so that's the reason we accelerated the adenoma study because I think the key to us to the trials is having very good detection in early stage cancers and pre-cancers. So we were very, very excited to get such great data. To be getting 75% of the dangerous pre-cancers in a non-invasive test is far better than we could have expected. So now we have those new biomarkers we were putting into the larger population. So it will be this year and the 4,800 we're processing right now.

Okay, great. Thanks, Cameron.

Thank you, Brian.

And we'll take our next question from Yi Chen with H.C. Wainwright.

Hi, thank you for taking my questions. First question is, can the option of CLIA lab [ph], can you comment how -- will that potentially affect your pricing? And how will that affect the reimbursement of the test? Thank you.

Good question, Yi. So obviously with CLIA labs we had two choices, either we license it out, I can license that to someone to develop their own lab test or we develop our own lab test. And -- so it would be up to assuming we licensed it out to some developer, it would be up to them to decide what the pricing structure is. 510(k), obviously we keep a lot more control over, we have some control over but we do have very little if we license it out. So the pricing, how strong biased we've always been to keep the test very affordable and make very wide adoptions always possible, we think that's why there is such a large number of other biomarker tests which were used, which were very single tests like PFA. They are very low cost, very easy to administer test. So our strong bias has always been to make it affordable and given the low cost of production, it's very, very lucrative for us. As the final pricing structures we haven't finally determined, that will determined as the product rolls out. But we see them as very large markets. The 510(k) becomes probably a bigger market because then it can be run in any laboratory in the U.S. so I would -- we're doing the detailed work now so this is my personal opinion but I would say the 510(k) market is a bigger one than the CLIA lab market and we would keep a lot more control over the process if it was a CLIA lab where we were licensing. So we're very keen on the 510(k) process if it's one which is acceptable to the FDA, which we're hopeful for, we'll find out this year.

If this was 510(k) test, will it be following investor [ph]?

I would expect so but the exact answer to that question is while we've got a pool review being undertaken by Dr. Charles. So he will be announcing all the prices but that's certainly my impression.

Okay. The second question is, shall we expect to see more lung cancer diagnostic data in the coming quarters?

Absolutely, we're very, very serious about the lung cancer work and we have trials underway. And we've actually got two ongoing at the moment. So we expect to see a lot more lung, prostate and pancreatic data.

Lung cancer data?

Yes, so the answer was yes for lung cancer but probably the next big read out will be in the prostate cancer that we expect this year. Yes, we've got lung this year. Thank you.

[Operator Instructions] We will take our next from Bruce Jackson with Lake Street Capital Markets.

Hi guys, good morning.

Bruce, how are you?

Good. If I could just comment on the colon cancer program real quick, so first with the retrospective trial, are there any possible issues like antibody production, anything that could affect the potential timeline for the second half read out?

Good question Bruce. As we've announced before, we've been undertaking large antibody programs and not only do we control the antibodies ourselves but also it brings the cost down markedly when you have well defined monoclonal lines yourself. So we've been to know -- and we've got a lot under development, so we're very confident in the process that it will not delay, there is always a possibility when you have several moving parts that one of them slows down. But we're confident in the production of our antibodies and that we've got the prices underway and on-time to meet our targets. But antibodies is something we're very, very serious about, it's a very key part of our business, we spend a lot of capital on developing our own monoclonal lines. So there is no slippage in any of the trials from antibodies. So when we have it developed ourselves and tested ourselves, it's not -- much, much cheaper than buying them, up to 80% or 90% cheaper but also you have complete control and can produce in large quantities as you say for the products. So what we've been very much focusing on is developing our own lines and testing the trials in every case where we have them, our own antibodies so that we can roll out the product quickly and seamlessly from those. So the short answer is, we believe it's under control and we've spent a lot of time and effort on the antibodies to make that a bigger chance as possible.

Okay, great. Then if you could just walk us through the critical path on this project, so we've got to get the training -- set up your algorithm, validate the algorithm, and then get CE mark on the NuQ panel that you want to launch. So can you tell us what are the re-eliminating factors here, which trials are going to be getting which pieces of data from and how this whole thing unfolds through 2016?

So the extra seems small number of patients, the small number of hundreds, so that's not the big trials. But the data which will drive demand are the 4,800 patient study which will be the first one, the very big read out as you know, around 80% sensitivity and specificity on that at the moment, 78% to 81%. We have the biomarkers which worked extremely well in the smaller population, but still very meaningful numbers in the 430 patient study, so we're putting them through now. So we aim to pick the panel, so we'll have -- we're running those new assays now, we aim to pick the first panel over the summer and begin to see marking process as a panel and have it ready with the algorithms and all things you mentioned this year. And then launch it this year although as we talked about, it will take time to generate revenues as you -- but we don't expect anything to do with production, we can produce large quantities of our own antibodies and replace them very quickly. This comes down to getting acceptance from clinicians and key opinion leaders to roll out the product. So we've begun that very strongly in several European countries and now with Dr. Trial, we're starting that process to really start the U.S. market seriously with his work in getting the 510(k) process started.

Okay. And then to be clear, the data is coming -- is it coming from the Danish studies or is it coming from any other studies? Which studies are we going to be focused on?

Good question. The colorectal -- the two very large colorectal, the completed one and the adenoma was from Denmark. The two very large studies in colorectal which will have read outs from this year; the 4,800 and the 14,000, both in Denmark. The other big I think in the short-term are in prostate cancer, and if in a range of different groups, in Europe, in England, from Surrey, from the trial and another one in Europe, so expect that in the short-term from them. And then the pancreatic cancer trial is with Dr. Harold [ph] in Germany. And he is unique in so far as he runs the trials himself, he -- we have two Teacan machines and we send him kits, he collects the samples and runs them. So in our -- it's completely in his hands and it's very encouraging, the results we're getting from the two centers are very, very similar. So it works in different centers. Each one of those is little different and how it works but the actual -- Dr. Harold [ph] does everything except make the kits, we send him the kits and he collects the blood and does all the testing because he is an expert in nucleosomes himself. I've send this blinded samples typically, in Denmark takes double-blinded and we randomize them. And then, usually what happens is, you have a swap over of data at a particular day we send the -- when you unblind it, we send the sample data and they send the patient data. So both sides have the other half of the puzzle at the same time.

Okay. And then, I mean to get super specific here, with the -- the trial for the CE mark, that small sample, where is that going to be drawn from? Is it going to be a separate trial or are you drawing from another trials that you're currently running?

Each one depends on the population what you're after. The last subject was from -- subject from the Danish trials, shipped to them but they run independently, go through prices from the CE mark, the CE mark mainly runs around other tests as the whole system to making them accurate. But the trials themselves are not very -- not large, that's why we're doing these massive trials. I mean 4,800 and 14,000 trials are very, very large trials for marketing purposes as much as anything else. So that we've shown it works in very large population. But the actual trials for the CE marks, in small number of hundreds, and they can be drawn from different locations as long as they are done in set process which is proper prices which they were.

Okay. Then once you get the panel launched, I believe you said in the press release that you're expecting some meaningful revenue in 2017. Is there any quantification you can provide around meaningful?

We're not providing revenue guidance at this stage, it's tough to know which country is -- we're talking to several countries now, we're looking outside Europe where other places where you can sell with CE mark to the private payer market. But I don't think at this stage it would be accurate. Our predictions until we've really done the numbers ourselves but we're very active in working with several groups to our distribution in Europe and in other places and basically where we have home advantage in Europe which would be United Kingdom because a lot of the English have experienced with NHS and we speak English; Belgium, of course, where our home is, particularly the French region; Denmark, where we work very closely with the Danish screening program; and Holland and France, and they all are bit different in different models. So we've done a lot of work on it but we won't be providing guidance until we've got a lot better idea of what the take up time in each of the countries is going to be. I do believe we have a very compelling case. In Europe, almost predominantly, the tests are cheaper, more inaccurate test is lot of FOBT and FIT tests, I think where much more complined, much better accuracy early and where we can be very competitive on costs. So I think we've got a very, very good argument but tough timing on those, we need to do a lot of work before we provide guidances to what the revenue is going to be in those years.

Okay.

But as we say the good years, the good years have been we don't spent very much money, so we don't need to be -- a lot of companies spend tens of millions per quarters, we're a very low amount per quarter. So meaningful doesn't have to be a huge amount in that first year to be meaningful because we were hopeful and we're doing, working very hard to get revenues quickly as we can but it's -- what meant we're very comfortable with predictions and guidance we provided but we're still in the process of developing those models and really actively working on them.

Okay. Last question, as you mentioned some warrant exercise last quarter, how many warrants are still outstanding as the cash exercise? How much could you potentially get from those if they were just…

It's all in the 10-K, its several million dollars, no exact figures. I don't remember it but all in the 10-K. It's quite large and the average is between $250 and $350 by the options. But it's considerable and we've had considerable income from it this year. That's why we actually went just around $1 million in cash this quarter because there were some warrants exercised. And if you look at it, if you take a further step back, I mean the net was around $9.7 million at the IPO, we still had $5.9 at the end of the year. So a combination of last month being mentioned and constantly having some warrant income and other things have really helped us to keep the burn really, really low. Still while doing non-ongoing pinnacle trials and up listing and being in the process of doing the regulatory work. So we keep a very, very tight ship.

Okay. I've actually got one more question, so moving over to the U.S. regulatory strategy, specifically is this going to be a denovo 510(k) or is it one of the newer pass list?

There are several options and we'll keep everything open until we remember the FTA but the options are predicate or denovo, it depends on, I guess -- if we consider some of the tests out there are predicate or not, if not, it will be a denovo. And I don't believe, Dr. Trail is focusing on denovo, just in case there isn't a predicate.

All right, that's it for me. Thank you very much.

Thank you very much, Bruce. Thank you for your time.

[Operator Instructions] And with no further questions in queue, I'd like to turn it back to our speakers for any additional or closing remarks.

I'd like to thank you all for your interest in VolitionRX. It's going to be a very exciting 2016, as well as extremely good in 2015. I think you see from all our milestones, it was a tremendous year for us. And we continue to gain momentum in all the trials we do and with the regulatory work and with aim of launching our products in 2016 and 2017. So thank you very much for your interest and hopefully we can continue to deliver on the milestones and targets as we have done for the last five years. Thank you very much for your time.

That concludes today's conference. We thank you for your participation.