Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRX Limited Second Quarter 2018 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, Tuesday, August 14, 2018. I’d now like to turn the call over to Scott Powell, Executive Vice President, Investor Relations. Please go ahead.

Thank you, and welcome everyone to today’s earnings conference call for VolitionRx Limited. Following our prepared remarks, we will open the conference call to a question-and-answer session. 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 an 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, Scott, and thank you everyone for joining Volition’s second quarter 2018 earnings conference call. I would like to thank you all again for taking interest in Volition at this key time for us. In addition to Scott, David Vanston, our Chief Financial Officer also joins me on the call today. I’m delighted with the progress we’re making on so many fronts, which has been made possible by our growing expert team and lab staff at our considerably larger 19,000-plus square foot purpose-built facility in Namur of Belgium that opened last year. In Italy, I would like to highlight some recent developments. This past week we have made great progress with exciting news including the closing of $9 million equity financing with a long-term existing investor. That along with the $11.9 million cash on hand as of June 30, gives us more than $20 million current cash position, which gives us a long runway to lever on the numerous trials and product launches we aim to complete in the next 6 to 12 months. We heard that our cash position will be further strengthened by the exercise of outstanding warrants with exercised price in the range of $2 to $3 per share that expire within the next 12 months, and which if exercised, could provide approximately an additional aggregate of $18 million cash to the company. We believe that all of this plus any additional non-dilutive funding and revenues from the sales of research kits puts our balance sheet in a great position. Furthermore, we have made significant achievements in many areas of our product development and we continue to be well within our target expenditures. We are extremely careful to minimize our cash burn rate and to keep it stable, taking into consideration our stage of development and…

At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is from Jason McCarthy with Maxim Group. Please proceed.

Hi, thanks for taking my question and congratulations on the recent prostate data.

Thanks, Jason. It’s very exciting.

Yeah, I was wondering actually as you guys continue to advance some of your pipeline beyond CRC. Given the minimal amount of blood required for Nu.Q. Could you run multiple screens of the same draw and integrate those into routine blood work because I am sure anyone over 50 and their doctor would love to just check a box for prostate CRC lung screening on the same visit.

Yeah, absolutely, so they are all separate trials of course because they are collected for different reasons, but we only need a small amount of blood and typically several mls, four or five mls have given in a typical draw, so our patent was currently a few hundred microlitres, so absolutely you could screen for multiple cancers, but I think that will be multiple screenings. I think it’s very tough to get FDA approval for one screen for lots of cancers, I think it could have several screenings for different cancers. But absolutely that’s our goal and I think something which we’re absolutely in the process of doing the trials for.

All right and then just back to the prostate assay, so the recent data demonstrating 94% detection at high specificity. It seems to be on par with what we have seen in CRC. So would it be appropriate to interpret that this doesn’t just speak to prostate cancer, but to the versatility of the Nu.Q platform as a whole.

So, yes, it does speak to development of the platform absolutely. So it’s extremely exciting data. We should just also note that it was 84 samples have been very well collected multi-center perspective. It was actually part of Walloon Regional grant. So it’s a very well done trial, but it is 84 samples. But the p values that were – significance were excellent. So we’re very confident that we ran a very good trial. It would be an amazing product if it was anywhere near the accuracy that we were in this trial because actually determining the high-grade count is the real question now in prostate cancer. As you’re probably aware, the PSA can detect quite a few cancers it is not a great test. But what people really need to know is, is it an aggressive or is not an aggressive. Because it is one of the few cancers you may actually just leave alone, if it is not an aggressive cancer, it is not going to kill you, where obviously you want to know pretty quickly, but it is something that we are very excited about. But I think we will, the next step is clear as to run a big trial. But it doesn’t have to cost a lot, doesn’t have to take a lot of money. But we always look to work with partners who have collected great samples as before and that is of course, the strategy we are taking as we speak to see what we can get in a prostrate trial.

Okay, that is great. Congratulations on the progress.

Thank you.

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

Hey, Cameroon, congrats on all the progress and thank you for offering explicit guidance on the revised colorectal timeline. But that was going to be my first question. But if I can focus on the prostrate diagnostics study just for a second, can you tell us what the reasons for defining high grade versus low-grade patients. And can you comment specifically on the test performance in the low-grade population.

Actually, I anticipated these very scientific questions, which I obviously I am not a scientist myself. So, I have actually I have got on the call additionally Dr. Micallef, who is our Chief Scientific Officer, who is much more familiar with the questions and hopefully knows the answers. So.

Okay, good morning. Yeah, what we did for the grading of the cancer, was we used the Gleason scores. I am sure that you know that the Gleason scores are of seven and below. Usually considered low grade. If the seven is three plus four we could go ahead 7a if you like. And then high grade is seven and above if the seven is four plus three we call it 7b. So it is kind of 7a below is low grade, and 7b and above is high grade. We use that score as the normal score that clinicians use. And then that is used in combination with TNM stages of cancer. And we are still in the process of working that data out. So we will write up and publish all of that data as well. And in terms of the low-grade and the high-grade, all of the men that were tested were suspected of cancer. So there was no healthy man and it wasn’t a cancer detection exercise if you think of it in that terms. What it was, was men that were referred for prostate biopsy because of suspected cancer. And most of them even the people with now cancer had high PSAs. And that’s why PSA was such a poor indicator of disease that needs treating. In terms of the low-grade what we got was that at very near perfect specificity for the men with no cancer in this test. So very, very few false positives amongst the men with no cancer, probably something like 10% false positives amongst the men with low-grade cancer. So what that would mean in reality is that some men that arguably didn’t need a prostate biopsy because the outcome was negative, might be positive. Of course, currently all those men have a biopsy anyway and there’s no test, which comes close to that degree of accuracy. In addition, I would add that what the clinicians do is that they like to re-grade the cancers based on TNM staging as well and normally something like 10% of low-grade cancers would expect to be upgraded as it were into the higher grade anyway. So it may well be, but many of those people would be re-graded. But overall it’s incredibly accurate test, it not only differentiates low-grade and high-grade, it actually step wise increases with every single reasons as it goes up it really does correlate with recent score. It’s a very good initial was out, we need to temper that with the small number of patients tested, we need to redo it and confirm it in a bigger patient set. But overall, it’s a very good preliminary result.

It’s very….

Has your question been answered?

It does absolutely. And my only other question is with regard to the Bonn27 study. I’m kind of wondering about your plans for how the data will be used from this? Will this be an indication by indication basis, or will we see sort of the collected results from the entire study released at once?

That’s actually a good question which we haven’t finally – we have to work with our collaborator, Dr. Holdenrieder, who fought for everyone else’s benefit. He’s probably the worldwide expert in nucleosomes beyond our organization. He knows him very, very well. We’re going to be running the assays and we will sit down with the data as it becomes available with him. Again where are you running the product grade assays that will be on a similar time scale to the frontline screening test because they are very, very valuable samples, 20 different cancers in one trial is a very unique trial. But I guess that will be up to him, it’s always a mixture of publications and a little bit of news announcements as well. But I guess that’s partly determined by what his wishes are, he’s a very eminent scientist and he’ll have his own thoughts on what he want, how he wants to do it. So that’s something which will probably put a fine tune on as it gets closer to the data coming out. But it’s a trial, we are very excited about and running everything through those, it’s a very final grade of assays, will give us very – we are very hoping to bring things ultimately range of different areas. But how we actually publicize that in publications that could also be intellectual property issues so we may have to tamper that and slow that down a bit with some very patentable things, which we found out differences between the cancers, all similarities between them. So that’s still – I don’t know I have answered a known answer but at the moment, we are still determining that but I wouldn’t want to say exactly.

Fair enough. Thanks for taking the question and congrats again.

Thank you. Thanks for your time.

Our next question is from Brian Marckx with Zacks Investment Research. Please proceed.

Good morning, guys and congrats on the progress. Cameron, I want to talk about Asia and the two studies that you announced with the University of Taiwan and then there is the smaller Singapore study. Relative to the Singapore study, I assume given that it’s a relatively small study that it’s a symptomatic study, is that correct?

Yes, the Singaporean sample is a mystery of cancers from screening asymptomatic, obviously the problem with screening is very, very few cancers as a percentage and when you only have few hundred samples, 719 but you are not going to get many cancers. So it’s been enriched with cancers from the screening population which would tell us a lot about the Asian population but that’s why I didn’t mention it too much on the call today. It is actually we are looking what I did mentioned today is we are looking to get some work done in symptomatic population as well because asymptomatic that is also we’ve been told by clinician is a very useful one for them as well, not for the very obvious people that you are bleeding – back side you probably need a colonoscopy but for a lot of other people, there’s a lot of grey areas and we’ve been told to symptomatic that so we’re looking for some symptomatic cohorts, including some in Asia, which we had predominately screening one which is in the Singapore, one which you mentioned, which I didn’t mention on the call. And also the Taiwanese neglecting a couple of thousand symptomatic patients but the Singaporean one will help us probably mostly either symptomatically or ethnically because as a frontline screening test it’s probably not perfect.

And then in terms of the University of Taiwan studies, you had said in the past that for countries in Asia that accept the CE mark that you may need population based studies for commercialization, prior to commercialization is well, leads to university of Taiwan studies for fill that requirement to go to essentially commercialization after that.

Yes, absolutely. So Prof. Chiu who is absolutely – he is extremely well connected, very closed to today’s studies with the Taiwanese screening program. Taiwan from memories just have a 20 men in people, so it’s a sizable country. Approve them to some of your dream country and the closest to Chinese population. So if you want to do a trial without going to China, in the since early, issues in some time we have in China, it’s a fantastic, we’re doing it. So it’s extremely well collected and design trial. They all have had very rarely in Europe did not get this, but in U.S. you do. Everything one of them we’ll had a colonoscopy also had big data and also had a range of blood test and then let’s see, so it’s about the perfect population for trial. And in a very good agent population being a Chinese originally its obviously applicable directly to China, which are them still always $1 billion posted market, $20 million posted market. So we couldn’t have the better collaborator, it’s actually – its coming to Belgium in early September. Very well connected, very big in despite extremely strong keeping in leader in Asia as well as Taiwan. The sample it’s like fantastic if you will. So if those trials do go well, I think would be an massive hit stop, not only in Taiwan, but only for the Triage for the frontline hit, but also a massive hit stop for China, because obviously it’s extremely similar population. So all of those things I think and that – they’re also very strong is at keeping like most areas is a group of key opinion leaders. We’ve also mixed with close colleagues in is – in Japan, in Taiwan, in Singapore, in Thailand, all these things are very closely connected. So it is absolutely a great springboard for the Asian market and extremely exciting, we’ll have the first samples collected to do that June for the first half, which will be about 3,500 samples a very big set. They’re going to be run in Taiwan. We have an agreement there with a local companies around the mix. So it’s all coming together. So we should updated by Q3 or Q4 of next year. And by that stage, we’ll have a very large number of the final product right assays, so it should really speed up by that the device we’ve add on. Again, the device we’ve had with these trials in Europe will not be repeated in Asia, because there’s a product right – these not any good for every colorectal trial or good for every other trial. Once you have a very robust reproducible assay worldwide with evident. So we’ll be shipping them kits to run them in Asia over the summer next year.

So assuming these studies are “positive”. What’s next steps in Asia, I guess or is it to send as a question.

Absolutely. So the CE mark, it depends each country little different and we’ve taken on a couple of very solid team members in Asia now, Dr. Kway leads our operations in Asia. She has been trying to match it actually in China again and Taiwan in this last week. It’s a huge excite to have a CE mark and has a huge excite to have a massive key opinion leader behind your product. Each countries does have, it depends – they’ve only be different and I can discussing with you with a very specific, some countries, ones you have the CE mark, you can sell to the private market, which is a lot of Asian countries are private player, not insurance, but actual use to pay. And then the other countries, if there’s a system it tends to take about a years to get fully registered once you have CE mark for the government or the insured market if you will. So once you have that, it’s a huge step and if you have a big key opinion leader or key opinion leaders behind your process, it’s a much bigger process. So people have said, we could without these larger trials, which we absolutely could, but it would take few million dollars and the personal money we’re spending it, it’s fantastic leg out in a multibillion close to the market. It’s actually no burden for me to use fantastic key opinion leaders because then if they have designed the trial and you use order, those knowledgeable people would help me design the trial, help me run the trial and success then you are there. You have to commence them, they run the trial. So it’s a very exciting time for us. So I’m actually going to be in Asia, again in November and December really visiting these groups again, because I think strong part of our future is going to be with these trials and these processes in Asia where they are going for different model. The American model as you know is predominately insurance with some Medicare and Medicaid, Europe is almost all government, when you consider Medicare or Medicaid Asia has gone for a lot more of the individual payment systems from a different ways of doing it. So potentially, it’s a quite a quick way to get there if you have something which is what’s the low cost easy-of-use test, so it’s something we’re very excited about. And now that we have a very strong financial footing with all the money we have raised, we can really move forward with confidence in these large trials which won’t be really until next year in Asia to really launch these products.

Thanks, Cameron.

Thanks.

Our next question is from Alice Nettleton with Edison. Please proceed.

Thank you for taking my question. I have kind of commercial questions. So the first one regarding your colorectal cancer screening, so from what you said earlier, it sounds like you ringed at the CE marking until Q1 or Q2 2019 for the Triage test. Is that right?

That’s correct.

Okay. And then in terms of commercialization, what were your marketing efforts for the Triage test would be? And then the same question as well as for the frontline screening test?

Yes. I think it’s the same as well outlined before, but basically, there’s a lot different governments in processes of Europe as we found out. There are a good six or seven target countries, which have active screening programs with FIC in Europe with the obvious very first call protocol, which we’ve obviously done some work on for the Triage test, most notably Denmark, Ireland, Scotland, Holland. So we will be talking some of those countries, let’s again agree in the processing of doing now. but once we have the frontline test as well, as well as all the other countries in Europe. We look to the model begun for beyond where we have very strong relationships, if you use a European life supply. We’ve been chatting to learn something particular to have representatives Europe wide in all the major markets, and do nothing else, but launch product once they become valid and acceptable in emphysema and at the product. So we’ve – our communications and marketing, Dr. Louise has done a lot of work on this and we’re updating more than I guess as it gets very close to the product from that side. But it will be for basic model, it’s to work for distributors in Europe to do that work. Europe is a fantastic market, a huge market one with business opportunities, but it’s also surprising these facts, it is one team up, which makes that easier to do from that point of you. but each country has its own clock if you will. So people who are out there – the good news is, there’s a lot of companies they do nothing else apart from launch other peoples product in those markets, who had sales people, who have experts in the different regions of Spain and different region of Germany all over the Europe. So, we’ve been had a lot of talks with one company in particular. I think it’s the one we’re going to use. We’ll announce that if we finalize the agreement with them. But they do take a percentage of the revenue first, which is fair enough. So I’m very – that structure is very valuable, but what it means is that we don’t have to hire any extra people to do any marketing ourselves. So, I think that’s definitely the way to go. I think in Asia, we’ll do it a bit more direct country-by-country, but it is a bit more attractive, but Dr. Jason Terrell has done a lot of work in Asia for that and in U.S., Dr. Terrell Jason has done a lot of work on how we should launch our product in the U.S. So, we brought the granularity on that as we get closer to each of those products from the markets being delivered back to the general outline I think.

Okay, thank you. And the yes, regarding the U.S. the company Hypergenomics and they fail to get into the updated guidelines for colorectal cancer screening by the American Cancer Society, and there are still new blood based task recommended in these guidelines to other guidelines in the U.S. generally by Europe actually. And so I was just wondering what your views or an inclusion in these guidelines and whether it’s required for your product market uptake and reimbursement and things like that. Thank you.

That’s a very good question. So we absolutely – I think anyone out there is serious about and really sort it through to get compliance to the right of where it really has to be, which is 80% or 90%. there is absolutely no option except for blood test, there is no chance of calling off, this is going to get to 90% compliance in the general population. There is no chance in FIT test; it’s going to get 90% of the population. But very, very hard for any of those, is very much compliance countries with a national program, with the government absolutely asking people is in 60% to 70% range. So we think there is absolutely a place and a big place for frontline screening in colorectal cancer with a blood test and it has to be the only way of getting compliance, if they – that is a blood test, but a routine easy to use blood test. And having come across anyone else’s even close or developing a routine low cost larger based tests like our Nu.Q test. So, we think that the future is very broad for us, because of all of that and because of the platform, which I think is very unique and very good. dealing with that through U.S. agency is a lot of work and of course, Dr. Jason Terrell has been working with us for many years now and really strategizing the best way, the Preventive Services Task Force, and all those issues, as opposed to that something we take very, very personally and a part of that is also working with the early detection research network. The people we are running within the United States at the best of the best renowned organization that job, it is defined by…

Okay. Thank you.

Thank you, Alice.

Ladies and gentlemen, we have reached the end of our question-and-answer session. I would like to turn the call back to management for any closing remarks.

Yes. Thanks everyone, and thank you for listening through the call. I know it’s been a long run, there’s a lot going on. But it’s going to be a very exciting few months for us. And I really look forward to updating you in the November for the Q3 earnings call, and as we continue to go through all the data we have and announce more and more of the trial results, and we will continue to use the money very wisely to make sure maximizing the results. Thanks for your time. Bye.

Thank you. This concludes today’s conference. You may disconnect your lines at this time. And thank you for your participation.