VolitionRx Limited (VNRX) Q2 2018 Earnings Report, Transcript and Summary

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 the numerous activities that we are conducting. We believe that the exciting preliminary data we announced yesterday from a prostate cancer trial, gives us a further line in the water for a possible breakthrough product. Such data once more demonstrates the potential breath of our platform technology. And if the results are validated in a larger trial, this will be a very significant market opportunity. We have also recently announced the completion of sample collection in our endometriosis study with the prestigious University of Oxford, England. Progress has also been made on the Bonn27 cancer study in the enrichment of DNA of tumor origin work. We believe that the delivery of our product in one of these areas would have significant impact on the company’s success. Now let’s review our developments and financial results during the second quarter. Our focus during the first half of 2018 was on advancing the development of our clinical assays from the level of our past smaller trials to the analytical validity needed for large clinical grade trials and for products that can be run in laboratories and clinics worldwide. This development work will be key in our future success and is now very much bearing fruit. Throughout the year our team has completed an incredible amount of work to help ensure that our assays will be product ready. By that I mean analytically validated and clinical grade so that they can be very reproducible anywhere in any lab. This is a critical, albeit, a time consuming step in the product development process, but it’s not particularly needs where in terms of press releases. However, I would very much like to thank the team for their dedicated efforts. This mountain of critical work from our dedicated team is now becoming usable and is being used in a wide range of areas, some of which I’ll outline today. Our product development followed the two-pronged approach. First, we integrate all our improvements into discovery grade assays that can be used in clinical trials and publications. For example, the initial exciting data released yesterday in prostate cancer utilizing the discovery grade assays. These improvements include significant work on artificial nucleosomes at calibrants, something that we believe was impossible even 18 months ago. We have a lot of other trials underway in a range of different cancers and other diseases with these discovery assays and expect to also update on a second discovery grade trial of 300 samples in the second European population in the next few months. The second prong is we take the discovery grade assays and further develop them to product grade assays including the robustness needed for a long shelf life for all components to be run in any lab worldwide. These are then used in research kits and in the final product trialing and validation trials. This work has gone very well with our growing team at our large lab in Belgium. However, it is fair to say the development work on the robust of assays has proven to be a massive and time consuming undertaken. Giving that we are the first groups who have worked in this field of Nucleosomics much work has had to be done from scratch. Our family believed we’re taking the correct approach, but it has delayed the achievement of our previously communicated clinical milestones with regards to the larger product trials in colorectal cancer. For order of magnitude to describe the amounts of work we have undertaken to-date, each assay from the discovery stage to the product stage requires a minimum of 47 successful experiments, and we carried developing 48 of these assays. This work when completed for each individual assays is a need for future product trials. So it is a base of knowledge and work that is building an extremely strong foundation for what we view as a wide range of clinical and product of opportunities. Our intellectual property, the most valuable asset a diagnostic company has, it did samples, and in particular, clinical study samples. Therefore, we only want to test our large scale clinical study samples with five enlarged product quality assays, which is why the results from a large scale of trials had been delayed. On a separate note another advancement in the last quarter helped by our analytical validation work is a project I’ve mentioned on the last call investigating use of nucleosomes to purify or enrich nucleosomes of tumor origin. By way of background, one of the biggest challenges facing circulating cell-free DNA company is that most of the circulating DNA anticipations does not come from the tumor itself, but from dead white blood cells. Only a small fraction of the circulating DNA is of tumor origin. Since all or most of the circulating DNA circulate that nucleosomes at very exciting fact that has only recently been proven, and the nucleosomes of tumor origin are known to be different in structure, the ability to provide purified cell-free DNA has the potential to add considerable value to the company. This work is ongoing, proceeding well and we hope to have further updates in the coming quarters. Now from a financial perspective from the second quarter ended June 30, 2018 we closed out with a strong position of $11.9 million in cash and cash equivalents, which excludes the $9 million in gross proceeds from our private placement of the equity securities that we closed last week. We have continued to keep very close controls of costs, despite the high level of research and development and marketing activity with an underlying average quarterly cash burn of around $3.6 million. Yet again we have completed many milestones on a relatively tight budget, which demonstrates our ability to use that cash carefully and wisely. I’m delighted that this quarter we also secured an additional $700,000 of availability in non-dilutive funding from the Walloon Regional Government in Belgium. This latest funding take the total reserved to-date to an aggregate of approximately $3.7 million in non-dilutive funding from a number of local agencies. We would like once more to thank all of the agencies and in particular the minister of economy, industry, digital, training and employment, Mr. Pierre-Yves Jeholet for the ongoing support of Volition. We also released a video showcasing the facility including interviews with a number of our team members. If you’ve not seen it already, I’d encourage you to view it at our website as it really helps bring to life much of what I have discussed on our call today. As a direct result of our huge amount of background work we have done to generate assays of clinical grade with addition of aspects such as recombinant nucleosomes, something that only became technically possible last year. We announced this quarter the signing of an exclusive global license, manufacturing sales and distribution agreement with Active Motif for a range of our new research kits. This development work we have done on these research, RUO kits, is also critical in our clinical trial work, as working closely with Active Motif, perfects research kits has greatly assisted us in getting to clinical kits ourselves. As a reminder, the research kits use the same platform and assays as Volition cancer screening panels, but maybe used for many other purposes. The research kits will allow researchers to explore patents of epigenetic modifications in circulating nucleosomes across a broad range of clinical applications, including cancers, inflammatory and infectious diseases. Active Motif is a key player in the field of epigenetics and we are very happy to be working with them. This is an excellent opportunity for Volition and we hope that this will provide an additional revenue stream beyond the commercialization of our blood based cancer test. The first kit, the Nu.Q Total assay kit has been finalized and is now available for sale through Active Motif. We believe the sale of these research kits will also broaden potential applications and generate further validation of our patent protected Nucleosomics platform. Indeed, we believe that Volition’s intellectual property portfolio will become an increasingly valuable asset moving forward, covering products in additional areas of biology and medicine. Our belief is based on the fact that epigenetics governs many biological processes in health and diseases in many areas, not just cancer. The research kits can be sent around the world and we aim to rapidly expand the platform as other researchers and companies will utilize our platform and our intellectual property for their field. It will allow us to collaborate with a range of organizations through shipping them our kits. I think the best insight the potential of these kits comes from a quote from Dr. Joseph Fernandez, who is the Chief Executive Officer of Active Motif who previously stated, we are continuously looking for innovative products in the field of epigenetics and believe that Nucleosomics is a breakthrough technology. These research kits will provide researches throughout the world with a new way to explore epigenetic modifications in circulating nucleosomes across different diseases from clinical samples. We are delighted that the first kit is now available for sales and it continued to work with Volition to develop a broad range of assays focused on important targets for future rollout. We expect revenue this quarter from the sale of these research kits. From a clinical trial perspective, we’re delighted to announce the signing and commencement of requirement of our two Asian trials in collaboration with National Taiwan University, with lead principal investigator professor, Han-Mo Chiu. By the way of reminder, the first trial would be a large scale study in the Asia-Pacific region including 5,000 Asian asymptomatic colorectal cancer screening subjects. And the second trial will include up to 2,000 symptomatic colorectal cancer patients. These studies are being conducted to test and validate Volition’s proprietary Nu.Q platform for the detection and diagnosis of colorectal cancer for marketing, rather than for regulatory purposes. These multi-country, multi-center and multi-ethnic Asian subject cohorts are in addition to the approximately 45,000 European subject cohorts and the 13,500 plus U.S. subject that are already part of existing studies and further demonstrate Volition’s commitment to commercializing its Nu.Q platform globally through collaborating with world-renowned institutions and key opinion leaders. In addition to our colorectal work, we are happy to confirm that we have begun analyzing the Bonn27 cancer study. This 4,500 patient cohort is already collected by the University of Bonn, Germany, and includes patients with the 27 most prevalent cancers. We aim around all of our clinical grade assays through the style as they become available; indeed the first of these is already underway. This study is incredibly important and we’ve heard that it will show the breadth of our Nu.Q technology and helps direct our further developments of Nu.Q tests for other important cancers, most notably, lung, pancreatic, prostate, gastric and ovarian to name just a few. We expect to report preliminary data from the Bonn27 cancer study by early next year. It will be extremely interesting to see how our assays work in similar and different ways through these various cancers. We aim for this to become a platform for licensing our assays to a range of other organizations that are expert in these individual cancers. I’m also happy that collections has been completed in one of our non-cancer study, mainly the endometriosis study in conjunction with University of Oxford, England. This collection of some 350 patient samples has been completed over the last three years. We’ve not discussed endometriosis clinical for quite some time. But the need for simple diagnostic is significant, it currently takes on average of between eight to 10 years for diagnosis to be given, it is prudently too late leading to a significant impact on the patients quality of life and often to their reproductive health. We aim to run all of the discovery grade assays through this trial as they become available this year, and these are first tranche of assays that have already been run in the labs and we’re waiting data processing and analysis. Our report have been health in preliminary data as soon as becomes available over the coming months and quarters. As we progressed though this initial Proof of Concept Study, we will provide more background detail on the nature of disease and its positive opportunity. But once again for now, I’ll simply say that this is a trial that is very important to us. With large and once more to be working with the quality collaborator from leading institutions and again, we hope that we’ll show the breadth of our Nu.Q technology. I would also like to highlight the significant preliminary results, we announced yesterday from our prostate cancer study. At 88% specificity, the Volition panel of five assays including PSA identified 94% of high-grade prostate cancers that require treatment, according to the Gleason Score method. This is a large improvement to the prostate-specific antigen or PSA alone, which is identified 33%. Even we expect these discovery assays to be through to the final stage of product assays later in 2018, we hope to conduct follow-up product trials in the first half of 2019. This prostate has been screen in blood for over 20 years, we believe that we can secure larger trials in short order. And so the upcoming milestones for the remainder this year and early next year. We expect to generate revenue from the sales of our research kits through Active Motif and as we add in products for sales to ramp up next year. To be clear, we think having a large number of researchers in companies will greatly add to the validation of our Nucleosomics platform. However, we would expect much more significant revenue to come from our sales of clinical products we are developing rather than these research kits, sales which we expect to commence in 2019. We aim to have enough final product assays to release data on our updated Nu.Q Triage product before the end of this year, and expect to complete the validation study and CE marking process in early next year, and then launched the product in Europe. We aim to report data from our frontline screen test in the first quarter of next year with the goal of completing the validation study and CE marking process in the first half of next year. In addition to our other work in colorectal cancer, such as the second discovery trial in 300 European samples that we expect to update on in the next few months. We aim to report proof-of-concept data on the validity of our platform technology from other trials such as the Bonn27 study and the endometriosis study as mentioned earlier. We also aim run validation trials with our very promising preliminary data from the proof-of-concept prostate cancer study, which identified 94% of high grade cancers. This says we have another excellent opportunity to our long list. PSA views in the panel that we announced should – all be through the final product stage soon, so we could run product trials as soon as we can get them next year. I’ve said this on many calls before, but I would like say again it’s the people to make the difference and I would like to sincerely thank our visionary team for the significant progress we have made this quarter on so many fronts. It has been very much a building year with a massive amount of work underway and completed. This is not the easiest thing to convey to the market, but its critical work if we are to be successful in our goal of revolutionizing cancer diagnostic. We’re extremely excited and optimistic about the coming months. We have been very active in adding team members and clinical trials that would help us to transform the company from one of research and development to one of selling commercial products. We have done a huge amount of work in the background, which is not news in the sense of press releases, but it is extremely important in a huge amount of work that has been completed and has made it for the robust clinical trials to ultimately launch products. We are extremely proud of the accomplishments we have achieved thus far and look forward to work with future halls of Volition. I along with rest of the board and indeed the whole company look forward to sharing these results and key studies over the coming months and quarters. We worked very hard every day to create a brighter future when we’re hope and can come together in the same sentence.

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 tests that can become part of the screening program. therefore, the trial we have is the – it’s been run by them fantastic, then it doesn’t really know what they’re doing. But I think anyone, who says it’s an easy process in the phase of wholly themselves, it’s obviously a massive market and one, which is always a bit – it’s difficult to probably get grip soon. but we’re taking it very seriously. We think we have something very unique. We think it’s the only solution. So, I think we’ll get it done. And U.S. unlike the vast majority of U.S. companies, we have a lot of options in Europe and in Asia, and a range of different countries and reinvestigate for the same platform. So, it’s not something, which is to make or break happening within the first year for us. We have a lot of options, a lot of short-term goal internationally as well as in the United States. But it’s something we have thought a huge amount of that, and we’ll update everyone on that as it gets closer. The collection by the way is proceeding well with that 13,500 advanced trial with rep products, the 13,500 U.S. trial, so that should be a massive piece of news in the next few years. It’s also just sticking along in the background, while we’re doing the work we’re doing.

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.