Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the VolitionRx Limited's Full Year 2019 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, February 21, 2020. I'd now like to turn the conference call over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you, and welcome everyone to today's earnings conference call for VolitionRx Limited. This call will cover VolitionRx's financial and operating results for the fourth quarter and full year 2019 along with a discussion of our recent activities and key upcoming 2020 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 Benston, 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 any obligation to update any forward-looking statements made during the course of this call. I'd now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thank you everyone for joining VolitionRx call today. I especially appreciate that given the busy earnings call season. Let me first start by saying how extremely excited it is to see our field of epigenetics become so mainstream over the past year, which has always been our hope. We have been working for a decade now to develop our epigenetics platform, intellectual property, team and products and so to see this all come together at a time when epigenetics has become so widely accepted one could even say hot is incredibly gratifying and shows the amazing vision of our scientific team. To every one of our team members, I am in owe of your fortitude and grateful for your perseverance particularly given the fact that cutting-edge innovation is really a straight line. I'm happy to say that we have great momentum and have made significant progress on many fronts over the past 12 -months, particularly in assay and platform development with our Nu.Q capture program, our colorectal cancer and lung work, Nu.Q Vet in collaboration with Texas A&M University and most recently with the acquisition of Octamer to expand our capabilities in epigenetics and further our goal of bringing all three components of our test in house. Firstly though given this is our 2019 full-year earnings call; let me start with the financials. We close out 2019 with $17 million in cash and cash equivalents versus $13.4 million at the end of 2018. We continue to enjoy exceptional shareholder support throughout the year receiving $16.6 million in cash proceeds upon the exercise of warrants by existing shareholders. We also further strengthen our balance sheets with additional non-dilutive funding driving $3.3 million from New York stock program and various governmental agencies, taking our total non-delivery funding to date towards $7.6 million.…

[Operator Instructions] Our first questions come from the line of Mark Breidenbach of Oppenheimer, please proceed with your question.

Thanks for taking the question. Cameron, I'm just wondering if, as part of the plans for 2020 include any side by side comparison of the new diagnostic format and its performance relative to your older micro tire place format. So let's start with that as a first question. Are we going to see any, like direct comparisons between the two this year?

Yes, absolutely. So thanks for the question. Yes. So the assay is the new beat based format as we said, it’s incredibly and basically sensitive so we expect very good results and the platform actually, the platform that we're demarking now is even that speed ahead of the place we had even two years ago because will be back- we've had - because the new types also include recombinants also includes in plasma non-theorem, all those things, so I think it can be difficult to go back to the place from three years ago, which even I can't place far better. But yes, look, we're having the key assays. We're not - we're only doing a few of them on plate now because the analytical performances is just really, really, really good on the base, I mean if we down to 1%, 2% or 3% CDs, that's a good the big - machine. So it's incredibly good, but we will have following benefits and also the market comparables, but I think you'll also see that in the panels where we've had, obviously we haven't optimized everything without checking that it's actually improving for the offense. And the results we've shown in lung, colorectal, and most recently, in blood cancers, the results were like we've never had before in one or two assays, that's what we didn't do big panels on small populations. But we can be side by side, but we're very hopeful for that results overall, and that'll be coming soon.

And just to be clear on some of the ongoing studies, specifically maybe the one you're doing in collaboration with National Taiwan University in lung, is that study using the new format or the old format and you know, I know in the past, you've guided we should expect a reasonable body of data from that trial in the first half of 2020. Are we still on track for that? Or are you in the process of switching sort of assay formats in that study?

So, the short answer is, everything we do now will be on the bead -based format, which is become so good and so to be a product and be robust, reproducible, all those things, which, obviously in the high throughput, the only thing that's going to be less than a low price is one or two assays, which we see marking, which are useful in the triage market where you add to some of those, relative to the assay showing to be incredibly good in the range of cancers individually but never got a product, we never want to further - so we are not to take one to that was going to be a blockbuster product in itself as a triage that is very good. So for every trial we do now apart from the triage, anything frontline or any of the others lung, colorectal are going to be on the bead-based format and instead we have four assays finished, we expect to have eight by the end of this quarter. So that's just next month, it's really picking up now where we really practice is a conveyor of those assays now, and that's on every trial we do, I think we're collecting a large amount of plasma. So, we expect to test it on the very simple platform. So things like triage, we will have the trial open on the range of assays for the most part one product, but also as you probably get from high department the team is also very bullish on the capture side, which holds the promise of more accurate, more sensible but more accurate tests along the lines of some of the other companies will include sequencing or precipitation. So we think what is as a continuing from the very low cost…

Okay, and just to be clear on the Taiwan study, should we still expect a chunk of data from that coming in the first half at this point?

Yes.

Okay. And one last one for me. Just because you're such a global company. I'm wondering if you anticipate that the Coronavirus outbreak is going to have any impact on your supply chain.

Not supply chain because we're very - one of good thing is being in control that any really two ingredients in our test antibodies and recombinant nucleosomes, so we now have them all in house. So not the supply chain but certainly it has been affecting some of our operations in China. China had been kind of slowed down for a month or two. So that slowed down a little bit but it has not affected so far Taiwan or Singapore and certainly not collection. But I said there's been a small effect on our operations due to - we are not tracking Chinese trials right now for obvious reason. - Busy I guess but overall supply chain was zero effect and will have zero effect because we produce them all internally. None of them come from China anymore. We've reported over half that I would expect some disruption in the trials in China and if it got a lot worse perhaps Taiwan but there's no sign of that yet.

Our next question comes from the line of Bruce Jackson with Benchmark Company. Please proceed with your question.

Good morning and thank you for taking my question. If I could, I'd like to talk about the veterinary business for a couple of minutes. So, you've got two studies underway. Can you tell us a little bit more about whether they're which animal so canine or feline? And then what are the assays that are being evaluated?

Yes, so the vet program, just quickly reiterate, we've shown very, very similar results in pre analytic as well as the results in the cancers. And one of the indications that we saw in little human blood cancers were at an extremely common cancer in dogs, particularly I believe Alceation and or German Shepherds but so we're recreating with half - recreating the exact lab in Texas. So we've done some preliminary studies, we are doing the pre analytics to make sure the collection protocols are very similar. And that's all looks to be very similar to humans, which are proving to be very stable. So our team there has been clicking samples from the hospital. It's a bit like a big clear lab next to a hospital, if you will Dr. [indiscernible] has their own animals and also there's a big facility downstairs. It's pretty remarkable facilities better than most humans are treated in the world. So, that's selected a range of samples, which we're very encouraged with. And now from bio banks and also collecting herself. She's taking hundreds and hundreds of samples, we focusing on dogs, and particularly I think, diseases is prevalence to different types of dogs. As I said, a lot of that is the blood cancers. But she is also got access- it's not public yet so won't you give the full details but we will do that in public and when we publish it, that she is accessing some very good bio bank as well as taking lots of stuff in the lab there. And, as I said to Mark previously, we expect results from that using a simple platform with the C Mark plate which expects ready by in the next quarter also still have the I-10 machine so they can run them on the magnetic bead, we've had fantastic analytical results. And that can be a very wide range of assay. And as exciting when we're doing it on the capture program, so that we'll see how capturing nucleosomes for the methylation markers, as well as sequencing growth on the animal side. So as in the human side, in Taiwan and around the world, we're going to have a very wide range of results this year. There is a very keen to publish and attend conferences and papers. I think there's going to be a big shift in the company this year. We haven't published a lot because we've been developing the platform. Also, we wanted to be sure about intellectual property before we fully went public with how it works. But now we're very confident with all those aspects. So, expect to see a lot of publications this year and the vet space will be a very important part of that the data, the process of putting all of those expected published in the vet space this year as well as in the human space.

Okay, great. And then in terms of the commercialization, how would this, how would these tests roll out to the market with this stuff? So Texas A&M has their own lab, for example, where they could start writing the test and selling it, would that be the first version that's available? And then somewhere down the road you consider going into a vet diagnostic platform? How are you looking at the commercialization process for vet test?

Yes, very good question. So yes, we're visited the labs as you know in October and they absolutely had a clear lab equivalent in the animal sense, but a clear lab in the basement so that we run a range of tests in there and as the trials go as well as they are going expect them to go very close. We will have the test running in their facilities this year and then that's running. They need a license to relate to the other big hospitals. But non-key ones, the kind of same hospitals where around the United States for the same purpose, and then go for US product. And also there are a couple of big companies in the space, [IDX, Mann]. We've been speaking to some of those groups also about building to other animals. We're kind of busy with dogs but cats, obviously, also a very big market that has revenues returns. So we've been looking most probably license in other animals because we can't -the model in early in all aspects has been to launch a few products that they think pump private if you will to start work and get it out there and then start licensing. So, I think we could start licensing in a wide range of animals to experts in those animals in the United States and worldwide. So, the short answer is yes. In the clear lab environment in the [Indiscernible] zone end we end this year, then a range of other ones around the United States and then other animal licensing.

Our next question comes from the line of Jason McCarthy of Maxim Group. Please proceed with your question.

Hey, good morning, guys. This is Michael [indiscernible] on for Jason. So I'd like to see if you could review the timelines on the human product, particularly Nu.Q triage and frontline, colorectal, as well as the one panel. And then also, when should we expect to see the data from the from the vet tests? And are those ongoing studies registration?

So, yes. [Indiscernible] the timeline for the product. And as I said before, I think it's been an absolutely phenomenal process we've gone through to get the assays as good as we possibly can robust, reproducible, and reliable. They can be a product, we have all the key components now, and we went out before. I get the whole technology was fully developed and it's worth that it's very tough to turn it into a product until you have it all, it's very basic vet finished. And it's been a huge amount of work. But as of now, I think it's very fair to say that all finisher growth has been finished so now about delivery and delivery means digest. I mean we really need to get out there and get the products out there. So on that continuing I was talking about with Mark from Oppenheimer to continue from the very simple the plate based format, with a couple of assays in the triage format. It's in the process of being C Mark now, the last thing for that product was the localization of the controls that's not finished. So that's now in process. So we'll have a C Mark kit, which has worked very well individually in a range of cancers. So the data in the lung and colorectal and in the blood cancers that was the core of that work. So once the C Mark will be using it in a range of trials which we expect to be product trials in the triage market, and things like lung, colorectal, the blood cancers. As far as the main assay platform, which everything else will be on, we have four assays finished. We expect to start the big trials once we have a bigger range 8 or 10,…

Thank you and then actually on the Octamer stuff. I like to see if you can actually give us a bit more color on the revenue opportunity there for selling the histone, the Octamer and the DNA template?

Yes. So this is something where we're looking to do how much effort we put into it. You're looking at so basically, we've far more get into secure and supply, because it's very few pieces - it's very new thing to do. And very, very few people in the world can do it well, so it's very important to bring it out. But revenue wise, rather than that, it depends on how seriously we take it, how much we're going to be selling. It is a very high margin business and that we make very predictably sense for ourselves. We'll update you next quarter. But you're talking revenues in the tens of thousands per month to start with in the first year. But if the pharma companies really take on these nucleosomes and drug development programs, it could be becoming millions in the years to come. Because there's very, very good nucleosomes, very few people do them. But I think if you are looking kind of the next deal or two in the tens of thousands, and then if we take it seriously and really pushed the boat out and pharma companies, and I think we bought this company because they do fantastic nucleosomes, it could get big in so 21 and 23, but in the tens of thousands this year would be reasonable, where we are moving to the hundreds of millions. But I think this is a kind of a- if you look where we are, the epigenetics, which is what we do, has absolutely become mainstream. And the DNA companies are moving towards epigenetics through sequencing and survival by conversion, which is we think the wrong way to go about it. It's very complicated, very expensive. I think that barring our epigenetic toolbox, which is through the capture program, nucleosomes, as well as the antibodies, we can not only provide intellectual property to license, but all the aspects of the test to really keep control of everything we do. So, I think it's something which could really take off in the next couple of years from the new agent side as well as the cancer side. But we're just going to read that ourselves. What's the next year, how big we want to get into it as selling kits or services or nucleosomes? But I think there's very little doubt now that the space we're in is incredibly important and it's going to grow exponentially over the next couple of years. So I think it'll make sense for us to dip out to the network before making nucleosomes for ourselves, and maybe we'll be selling them to other groups as well. So, that'll become to next quarter. But it's an aspect which we're taking very seriously and thinking a lot about. And when we finish that process, we'll make it a public.

Thank you. And then just one more, I'd like to see if we can focus on capture for a second and more specifically, the how behind it and the liquid biopsy space, what is really the advantage of enriching for nucleosomes compared to traditional methods for isolating CT DNA?

Yes. Very good question. And I feel good to have a chance to talk about capture. So currently, you probably aware there was a huge promise among sequencing in the past 20 years, it was going to solve every problem and I think that companies have done a very good job at taking selection, they said monitoring. But I think it's also a very competitive set of old files, early detection from DNA, because you're looking for the needle in the haystack of haystack. So now we're on magnetic bead. We've always just used the plate format, which is a very simple and good format. But once your magnetic bead that helps you manipulate nucleosomes in machines being magnetic, but we're also crucially does if you pull the nucleosomes out using magnetic, that's a very simple process, we call a meter precipitations while it's called immunoprecipitation. So, it's a simple approach, this is what assay is. So, whatever we do on the capture antibody on the magnetic bead is pulled out for concentrated for example, long versus short nucleosomes, short nucleosomes to been shown in Nature paper to be more prevalent in the cancer. But you can also pull out for things like methylation patterns, for example, which is where all the DNA companies are getting this discrimination now if the epigenetic feature of methylation patents. So, if you can, and we can pull out the nucleosomes and preferentially pull out by certain structures, methylation, or long or short or link DNA, you are really clearing out the pool as we say, if you're looking for a needle in the haystack, if you can sweep away the haystack, you can make a much better job of sequencing, and in concentrate by methylation patterns, for example. And a combination of all…

Thank you very much for your time. I'm very exciting time for us then we're looking forward to seeing all of you over the next quarter as we deliver the results which we've all been working on for a long time now. It's been 10 years and we have a lot going on. Also June 1st, we're doing the Capital Market today in New York again on the New York Stock Exchange. So anyone who could attend particularly the analyst side will be very helpful. We intend to have a lot of data by then and also quite a few of our experts you can really get in depth with on the questions. So June 1st will be a big day for them. Thank you very much for your time.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. And have a great day.