Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the VolitionRx Limited’s Second Quarter 2020 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 call is being recorded, August 14, 2020. I’d now like to turn the conference 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 Volition’s financial and operating results for the second quarter of 2020, along with a discussion of our recent activities and key upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today is Mr. Cameron Reynolds, President and Chief Executive Officer; and Mr. David Vanston, Chief Financial Officer. Before we begin, I’d like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs, as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the Securities and Exchange Commission. We do not undertake any obligation to update any forward-looking statements made during 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 Volition’s conference call today. I especially appreciate it, given the busy earnings call season, and the ongoing pandemic, speaking of which let us first start with an update on how the COVID-19 pandemic has affected operations for Volition thus far. I would like to reiterate how proud I am with the way that our team has adapted to the different world we find ourselves in and kept on working at full speed during this whole time, their fantastic efforts have put us in an excellent position as we move towards the launch of our first products expected later this year. During the first quarter of 2020, we implemented contingency planning to protect the health and well-being of our employees, with most employees working remotely where possible. However, in our addition to our remote efforts, our lab in Belgium has remained open thus far with the attendance of our dedicated lab technicians, social distancing, and observing other site verticals in our large 20,000 square foot facility. As the pandemic continued into the second quarter and indeed looks like it could continue for the indeterminate future, we focused on two key areas to try to mitigate the effects of the lockdown and allow us to keep moving towards our first products, utilizing our cutting edge Nu.Q platform. Firstly, and very importantly, we’ve significantly strengthened our balance sheet through both an underwritten public offering of our common stock and for the sale of shares of common stock pursuant to our existing At The Market offering program to ensure we have sufficient capital to work on our many programs concurrently, and launch products where possible during the pandemic. More and much strengthened cash position and our product launch strategy later. Secondly, we have increased the flexibility of our supply…

Thank you. [Operator Instructions] Our first question is from Jason McCarthy with Maxim Group. Please proceed.

Hey, guys. Thanks for taking the question. This is Mike Okunewitch on the line for Jason.

Thank you.

So first, I’d like to see if you could provide a bit more detail on the upcoming CE mark, you said it is expected on a maximum price, I think you said. So which triage has that CE mark? Is it adjusted for a single assay?

Yes, it is a triage product, it’s the blood cancer, actually blood cancers in humans and in the vet space have been actually best results for anything. So as we now – as COVID has excellent data, so we thought it’s a very good way of starting the CE mark process to help one product. And that’s actually the H3.1 assay, which also works well in a lot of other things. Obviously, one of our supplies had some major COVID issues, so we brought it back in-house. So it appears very soon to be finished in the next few weeks. So late September and that will really stop the process. So once we have the CE mark product, we can work with it in the blood cancers, but also where that assay is useful in other areas, it makes it much easier to see market for other purposes. And yes, it’s also the assay which was also very valuable in products. So it gives a huge head start in a range of different areas. The triage product itself we’re doing some pre-analytics work, which actually is being done in Australia, which obviously going back into lockdown. So we have an update exactly when we start marketing other products. But we will have the CE mark requesting and that gives us a really good building block for a lot of other products. So it’s a great start.

And then it’s actually relating to the blood cancer product. How many assays would you need to get a CE mark before you have an actual product to bring to market?

So the one assay actually was quite well, as a frontline triage or as an anti-drug. If you look at the results presented at ASCO the single assay actually was in the 80’s and 90’s AUC. So I think it’s getting better. So we’re doing a lot more work on the blood cancers. It actually – as you can probably see, it’s quite surprise how good it’s been to have worked in a range of different subspecies so quickly. So we’re doing a lot of work now on what the product would look like. So obviously the CE mark was cancer healthy, which is incredibly impressive, but we need to make better trials to make – what a CE mark allows you to do is sell it commercially. It doesn’t mean people are going to rush out and buy it. But by CE marking the product, when you run it in trials it gets – it’s product ready immediately. So H3.1 by itself had incredibly good results in the blood cancers. And once we finished the pre analytics, whatever that is given the COVID work we’re doing, because of pandemic. We’ll see if that’s a good enough assays to triage by itself. It’s good enough for see, like, what we see – what their take up is commercially. But the results as you can see from the ASCO work and I can share them again offline. We’re incredibly impressive. So that’s one assay by itself in the blood cancers. This is healthy. So it’s a good first step. But we haven’t talked about a lot in the call, because we’re not exactly sure of the process. We’re putting all the pieces together now, as it regards to products in different areas. But yes, we save mocking it, because the results are absolutely fantastic as presented to ASCO for that one assay. But obviously, the more assays you put together, the more accurate typically. So we’re working out now, but it seems like a very good step forward, for given this is an assay we’ve used it in a lot of different areas to make sure, if that it’s product ready.

Thanks, Cameron. And then I just one more on the COVID-19 test, well I assume, you can explain help frame exactly how this would be applied in practice. And you mentioned that will be largely focused on the high risk groups, but what’s the need out there for prognostic indicators and then what else physicians do with the information once they get it?

Yes. Very good question. So people, I’ve got prognostic and diagnostics, it’s a little confusing, that’s on one conditions, diagnostic tools you have it, prognostic tools will attempts to drug you, whether you’re going to be badly off, you probably familiar. A lot of people have very low or no symptoms. And unfortunately, some people get extremely bad symptoms. And other symptoms you get are actually the body’s immune response. It’s not the virus itself at all. It’s the immune response, which is the NETosis, which is something we’ve been looking at for a long time. Because it’s a long prior of the weak defense, which the body throws out to try and track the virus, which is why it called NETs and I guess that’s where that came with equity and backwards, I guess. But NETosis or NET, so what we measure is protogenetic and it’s a long chain for protogenetic. So a very simple product for us and potentially, because it’s very low cost, easy to use, something to be used vary widely, and that’s used clinically. So it’s unfortunately, like you were in the hospital with fever, do you go when you’re feeling a bit sick? It’s very hard to tell now whether you’re going to spiral down and say, takes of care quickly, or would you stay sick for a while, then we would get sick in the coupler or you recover, come back again. So what lacking is a prognostic knock it could actually where you are in that cycle? So what we looked at is the three types like this, we’re in the third stage now, and the first two are extremely successful, could be measured COVID from health, if COVID positive, otherwise there’s no point in having any tests. And it was extremely,…

All right. Thank you Cameron, again congratulations on the progress.

Thank you. It’s been a busy time. Thank you.

Our next question is from Mark Briedenbach with Oppenheimer & Company. Please proceed.

Hey guys. Good morning. And thanks for taking the question. Cameron, I guess, we’re used to getting updates on the progress with converting your assays to commercial grade formats. And I guess, I’m still trying to understand why getting 20 assays is a meaningful milestone given that most of your products would likely just use, maybe one or two or three Nu.Qs on a panel. Why do we need 20? And what’s really the rate limiting step now, since you have so many commercial grade assays ready to go? What’s really the rate limiting step for moving diagnostic panels forward? Thank you.

I liked your question. So yes, the simple panels, the ones to three ones, the triaged panels. So that’s why we’re very keen to launch products as soon as we can. I mean, the net results have been amazing in the blood test with one or two and in COVID test with one or two. So, that’s why I think during the pandemic we can launch them the way they are. So, we did – we always had targets to launch more assays on the place and it just took a lot of work, I guess when the CVs are as good it could be 15% that down to 3% now doing standard curves and all the work, I mean it’s hundreds and hundreds of experiments to assay to make sure it’s completely rebuffed. Now, we’re getting to a data, not just that we can run it or someone we know runs it, but anyone can not at anywhere, which I think is shown to be incredibly true now in the facilities in Europe where we run. So, we now – so having a wide range of assays to run in the trials works, because each one, I mean, as you know, there are 1,000 structures on the nucleosome or more including really very things like histone modifications, methylations, ventilations, populations, ubiquitylations and [indiscernible] it’s huge and we’ve never really managed to get a reliable test. Now, don’t forget the importance would be from place. We had some working on place, which worked okay. But the issue in serum was there was a lot of background signal. So the actual signal in plasma is very, very pure, and it’s a much significant noise. but we really needed to be on beats to get there. So, we took on a specialist…

That was a good story. Thank you very much. Congrats on the quarter.

It’s a complicated time.

Our next question is from Bruce Jackson with The Benchmark Company. please proceed.

Hi, thanks for taking my question. With the COVID-19 longitudinal studies, if I could get some additional details. So, I take if there are – there’s a study in Europe and then there’s going to be a study in the United States and the study in Europe, it was unclear from the press release, whether you had longitudinal data or not, or whether you were about to start the study or it’s in process, give us like the status of the European study and then how many months of longitudinal data are you trying to get, and then with the U.S. study, when do you think you might start that study and how long do you think it might take?

Good questions. So initially, this is Scott, the short answer is all of that. So we have some longitudinal data with [indiscernible]. Obviously if you go from low-to-medium-to-high, there would be a curve between them, but we can’t – it looks like until you have quite a few of them. So you need quite a few people and we’re working on the numbers now to make sure we get 50 or 100 to really try and make sure of what the curve looks like in between the different groups. We’ll definitely use the curve, we are just going to see what that looks like. So we have run some longitudinal data. We have got working with one institution that we already have. And we have collected what appears to be enough for a trial and its CE Mark is positive. But like everything, we have to go through an ethical process and ethics process and running them into months of longitudinal data typically, COVID actually kind of brings to a conclusion one way or the other in a week or two, so they already have been collected. So I mean the actual, the samples are collected running them doesn’t take very much time. But as you think from this last data, when you’re working with three or four institutions, it takes months just to kind of all package it up and everyone agree, there’s a lot paper there, 12 offices and four institutions. We are in dialogue with their management teams, getting everyone to kind of be clear what can be said, and how it should be published and we’re trying to publish everything now. So it takes some time. So the short answer is the longitudinal study, they are actually only a week or two per person, so it’s…

Okay. And then turning over to the National Taiwan University studies, you mentioned that you’ve completed eight of the Nu.Q markers is the plan to do – is the plan to do all 20 as they become available and – no, go ahead.

Yes. So, we have subsets of the two of them. As I was talking to Mark, from Moscow given supplies, we have limited countries we can run, 25,000 there is actually a lot of work. Normally it would be trivial because you have complete supply chains and everything, we are into six months, now everything is starting to dry up a bit. Again, while they are doing a lot of hard work now to guarantee all of that in large volumes. So yes, we run the assay, absolutely we’re going to run all 20 because we had the large volume of sample there. They are clearly good collaborators. And I like to again, thank them for that continued support during this time period. So we’re going to be ready, when we are ready, they’ll be ready and when pandemic goes off, I mean they are expecting very – they are actually stuck to that schedule, which was amazing. So we’ve split off the subsets to run the subsets of our assays and we’re not public subsets of subsets. We will publish when we have a big package of enough samples and enough assays. As we said as soon as we can, which is probably one of the conferences, but also conference moving down and they are going virtual and they are going to be kind of moving around. So I like to tell they are working incredibly hard, especially we are working incredibly hard getting assays ready. And we put together and we will be very happy to release results as soon as it’s all kind of put together.

Okay. That’s it for me. Thank you very much.

Thank you. Have a great day.

Our next question is from Nathan Weinstein with Aegis Capital. Please proceed.

Good morning, Cameron, and the Volition team. So thanks for taking my questions. I would like to ask on the veterinary health side, if you don’t mind, if you could just share first of all, what’s exciting to you about that market. Just seeing us on the commercialization front, it seems like it could be more in the near-term and also what it was like a plan for commercialization look like in that market?

Yes. Thank you, Nathan. It’s good to focus on the vet as well than everything else. So, what we talk about the vet market, actually a few things. During the pandemic, only a couple of assays have got very good results in very important lung cancers. We can launch products on a reasonably simple given the current supply chain. You already need to do hundreds – a few hundreds of blood samples to get a product out there. So at the moment we don’t have to run 10,000 trials. We’re no one can travel and the supply chains are a little bit messed up. And the market itself is absolutely phenomenally big. I mean, there is two and a half times more diagnosed every year with cancer in humans given the short life cycles. And it’s something which we take very good care about [indiscernible]. We could charge a very similar price to the human diagnostics. Also the collaborator Texas A&M, I mean what a remarkable work that they’ve done during the pandemic to continue on with the work. Dr. Wilson-Robles, which has been an absolute star and keeping things going and intellectual curiosity to accept what we do and understand it and adapt it to the vet market. The one of the most very best vet schools, so we’re incredibly lucky to be working with them, it’s not something we had a great partner with vet people at home. So that’s continued on – that has been good enough that they’re comfortable. I think they can launch product this year. And it’s something, which you continue to sludge more, more products, because that the range of vet cancers, that the range of animals. And the market is controlled by a few different companies in the U.S., so tremendous licensing opportunities as well as looking for in product. So, I think it couldn’t – we done across right at the moment. It’s a single product. Small numbers of samples give you product, it’s a massive need, it’s a great partner and it’s certainly something we can do during a pandemic. So let’s pick into it, [indiscernible] at the moment it’s on track and I couldn’t be happier with the work I’ve been doing.

Great. Thank you. Appreciate that insight.

Thank you.

Our next question is from Steven Ralston with Zacks. Please proceed.

Good morning, good afternoon, or good evening.

Good afternoon.

If we could get a little more granular on your two lead products that are closest to commercialization. You mentioned thanks to Bruce’s question that you’re looking at doing these studies in Europe. The size of the sample you mentioned in the 50 to 100 range of subjects, is that sufficient for the CE Mark?

Yes. Subject to those samples, so you’d have five or 10 samples from each person I would add to that. We’ve done a few hundreds and other populations as well versus healthy. And so you typically don’t have thousands of samples, because we have thousands of samples, but for money, a hundred people longer, generally I will add to that how many samples that we have to be. So, I was talking 50 to 100 where you follow the individual person to show the curve. But to show that actually works for different groups and the process is also very good background work. So I’d expect to be in that – a lot more than that. And again, that’s not what we have, we have a CE Mark now understand what’s required in the process, which we have in-house, that it would be hundreds, and hundreds, and hundreds of samples from hundreds of different people. And again, this comes out and tends to be huge and what’s available, and then you could add a lot more hoping towards get better specificity. I was talking about the COVID side of it, but you’d add probably quite a few hundred other healthy people. So you’d be looking at least 400 or 500 samples, I think, as a minimum to where you’d want to be. But that’s a good question but I’m not a CE Mark specialist, but we have a lot of people in that boat. But it has been lessened a bit during COVID because obviously everyone is in a hurry to get a product out there. But we’re very confident with what we’re looking at, with our CE Mark. That would be enough to get to CE Mark, and obviously we’ll get to CE Mark, it’s something which people would be interested in buying, given the numbers we have.

You mentioned you were going to use some of the same data from the second proof-of-concept study. How many subjects were in that study?

In that we had 142.

And much of that data can be used in the – along the...

That’d be part of the product. That would depend on the condition. The actual patients themselves and the products are being driven by clinicians. I’m not actually obviously wrote from the paper or the process, but we had strong edema continue internally and as you can probably think, as you got to tell them the type of public, there’s a dozen of different products and conditions on the – during the work for us. So we were getting extremely good advice on what’s going to be needed from all those areas for that – the part numbers with the revenue on them, but they will be – we’re not going to do it obviously, unless it’s enough to satisfy all the requirements, not only for getting CE Mark, but also to be marketable. And we’re confident. We want to make sure it’s not presented as well. So that’s yes – that’s not my specialty, but we do have very few people doing that. So I’m very confident when we go ahead and we’ll be on a very solid basis.

Moving over to the Nu.Q Vet that’s currently in the hands of Texas A&M College of Veterinary Medicine, and from what I understand, there’s a study either ongoing or going to be started that you just mentioned we’re going to have a few hundred subjects where exactly in that process are you?

So that is the range of different samples, they’ve got some biobanks, obviously the collecting has gone slow to fit from dose coming in from all the other regions. So they’ve gone to quite a few other big biobanks. So as far as I’m aware and I’m pretty aware they have enough in what’s happening there to do the products, which are – for the first product which is the monitoring for lymphoma and the blood cancers. So, what they have covering is enough to know if the best products they’re talking about, which is why they are confident doing this year. But they’re also expanding it as widely as possible with biobank samples, as well as with many large samples as they can. So that’s going to be submitting a lot of papers now on the pre-analytics, so they’ve done all the work. The assays are stable, and the samples are stable to pre-analytics that’s I think been accepted now, so that should be very soon. And we’re presenting a lot more data for conference in October, which would be supporting all the work they’re doing. So we post them last week that through very confident of reading the timeline. I mean, that can change if there’s an [indiscernible] COVID-related 16-week shutdown but, at the moment they’re on target for that. They have sound rules that that has been good for the product and they are presenting the data in the papers in the conferences now. So at the moment it’s all systems go on target.

And last question, you closed in the acquisition of Octamer in January, and looking at their website they have some pretty hefty price points. I’m wondering when the sale – their sales will start flowing through your income statement?

Yes. That’s exactly right. So obviously that hit right, as COVID did when we were. So what the aim has always been to absorb that name into the Belgian, so it’s now believes in Germany from Octamer. And yes, potentially this is why they’re very keen on reagent sales, being one of the four key areas to drive revenue, because you can sell for a few million in the ground. So obviously that could be lost with the programs, that’s sort of prediction that [indiscernible] people do small amounts and then get up to it. So we focused in the March, April, May sort of timeframe in developing our own capabilities. And as I mentioned in the script, we can now manufacture quite a few of those nucleosomes out there. But it was pretty obvious trying to do all of that in the same facility as the development wasn’t going to be what we needed, which is why we’ve been intent, it looks like the operates being still the one with a 10,000 square foot and we’ll move some team members in there. So given all the problems with supply chains, we focus more on 10,000 last few months, we focused on doing what we need for our hatred part one launch for the team up of COVID for the best part. And that’s the assays, which we’ve been developing the recombinant score. So that’s done very well. And now that we’re moving in, we expect and be able to move into these facilities up further. We’ll turn our attention much more to not just doing stuff for ourselves and secure it off the blockchain. But as you said, there was some – Octamer, we’re making sales. If overcoming nucleosomes and other things in Octamer. So in the process now…

Thank you.

Thank you.

We have reached the end of our question-and-answer session. I would like to turn the conference back over to Cameron for closing remarks.

Thank you everyone. I know it’s a very busy time. I really appreciate your interest in Volition. And I look forward to updating you throughout this quarter, as we have a little milestone coming up on the next Q in November. Thank you all for your time. Goodbye.

Thank you everyone for joining us today for VolitionRx Limited second quarter 2020 conference call. We appreciate your interest in Volition and look forward to speaking to you again in the near future. Goodbye.