VolitionRx Limited (VNRX) Q4 2018 Earnings Report, Transcript and Summary

Good morning ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limited Fourth Quarter and Full Fiscal Year 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 open for questions. [Operator Instructions] This conference is being recorded today, March 14, 2019. I’d now like to turn the conference call over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you, and welcome, everyone to today’s earnings conference call for VolitionRx Limited. This call will cover Volition’s financial and operating results for the fourth quarter and full fiscal year ended December 31, 2018 along with a discussion of our recent activities and key upcoming 2019 milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, President and Chief Executive Officer and Mr. David 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 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 conference call today. I would like to thank you all again for taking an interest in Volition at this exciting time for us. I am absolutely delighted with the progress we have made on so many fronts in 2018, particularly with the work on the basics of the Nu.Q platform and its expansion into exciting new areas. I am very happy to report the very first data from this work on today’s call and we expect to be able to report a large volume of data throughout 2019 and beyond with our newly optimized assays and matrices. We also expect in coming months to announce new trials and potential pathways to new products. But firstly, I will start the call with our all important financials. We closed 2018 with $13.4 million in cash and equivalents compared with $10.1 million as of the end of 2017. Subsequent to year end, I am very happy to announce today that we further strengthened our balance sheet with investments exercising $6.7 million in aggregate amount of outstanding loans to purchase shares of our common stock. This is in addition to the $13.4 million we had at year end. This shows very strong support from our investor base. Of the warrant exercise proceeds $5 million was from the exercise of warrants previously issued through an investor in our private placement in August of last year. This investor continues to hold warrants with an aggregate exercise value of $10 million at $3 a share that expires unless exercised prior to August of this year. We’ve also continued to attract non-diluted funding especially from the Walloon region in Belgium, which has provided over $3.7 million funds to-date. We believe all this puts us in a very sound position with regards to the financial runway to achieve 2019 key milestones. As I’ve said on our calls before, our research and development program is remarkably cost-effective, especially given the size of our trials, and the nature of our collaboration with leading institutions. Consequently, I am very happy to announce we continue to manage our cash very carefully and currently have a remarkably steady cash burn rate of approximately $3.7 million per quarter. Secondly, I am delighted to say that our worldwide portfolio of granted patents that protects various aspects of Volition’s technology, Nu.Q technology is growing steadily. This is another key differentiator with our many other technologies and other products under development or available in the markets. We now have 20 patent families related to our diagnostic tests with seven granted in the U.S. and seven in Europe and a further 25 patents granted worldwide. Additionally, we have 15 patent applications in the name of our subsidiaries pending in the United States and 13 in the European Union. This portfolio also covers the veterinary medicine applications which I will cover more later. We intend to continue our development of the Nucleosomics technology and we will continue to apply for patents in future product developments. Our strategy is to protect the technologies and gain market exclusivity with patents in Europe and the United States and in other strategic countries. The patent on the technologies underlining our products should provide broad coverage for each products including protection through at least 2031. From a research and development point of view, 2018 was a very busy year. However, it was fairly cloud in terms of press announcements as we very much focused our large teams on platform developments. Our team is truly delighted with the significant progress that we made in 2018. I personally would like to thank our research and development teams for their tireless and tenacious efforts throughout the year. The vast majority of the research and development work that we have performed in 2018 with focus on advancing the development of our clinical assays to the analytical validity needed for large clinical trials and for the products that could be run in laboratories and clinics worldwide, as well as extending the use of our Nu.Q assays in a range of platforms. This development work will be a key in our future success and our initial assays have been now completed its extremely vigorous process. Throughout the year, our team which now numbers 44 persons worldwide has completed an incredible amount of work to help ensure that our assays will be product-ready. By that, I mean, analytically validated and of clinical grade so that the assays can be very reproducible anywhere in any lab. This is a critical albeit a time-consuming step in the product development process, but is not particularly news where in terms of press releases. This mountain of critical work from our dedicated team is now becoming usable and being used in a wide range of areas, some of which I will outline today. This work is going very well with our growing team as our large lab in Belgium. However, it is fair to say the development work on the robustness of the assays has proven to be a massive and time-consuming undertaking. Given that we are the first group to have worked in this field of Nucleosomics, much work has had to be started from scratch. This work, when completed for each individual assay is then useful in our future product trials. So it is a base of knowledge and work that is building a strong foundation for what we view as a wide range of clinical and product opportunities including our research kits. We have also completed broader work on our platform including adapting our assays for magnetic beads and chemiluminescents. I want today go into great detail why these are both very important breakthroughs that could take this entire call, but they have made our platform much more adaptable and robust. I am delighted to be able to announce on the call today the clinical data from the first of our product grade assays. As a reminder, our strategy was to get the assays to a final product grade with all of our improvements including monoclonal antibodies, and using recombinant nucleosomes as calibrants, something that was impossible just a few years ago and is now routine in our assays. In addition to finalizing our assays, we are undertaking a complete review of all blood collection protocols to show every aspect is optimized. We then plan to initially test our product grade assays in smaller trials which we are doing now and then run larger trials of training and validations of our tests in a wide range of cancers and countries which is essential for final product development. We hope that improving the assays to a product grade would not only make them more robust and reproducible et cetera, but we also hope that cancer detection will also be improved as compared to the results of our non-product grade assays. So I am delighted to be able to report the preliminary results in three separate small cohorts with the first completed Nu.Q assay and IQ Nu assay that have been run in the past month. These are the first path of the preclinical assays on previously collected discovery cohorts that are in previous. In a lung cancer cohort of 76 subjects, a single Nu.Q assay detected lung cancer including the all important stage one lung cancer with an accuracy and The Area Under the Curve for this single assay of 85% lung cancer versus healthy. I believe this is the highest individual assay detection rate we have ever achieved. This performance was even further improved when using in combination of a two assay pattern. In a second confirmatory slightly larger lung cancer cohort of 152 subjects, the same Nu.Q assay also detected lung cancer. The Accuracy Area Under the Curve for the single assay in this trial was 79%. This initial proof-of-concept data gives us strong confidence to move on to larger trials and to put more company focus on to lung cancer. Finally, in a small colorectal cancer cohort, 123 subjects, a single Nu.Q assay detected an accuracy for colorectal cancer of 72% Area Under The Curve. In the same cohort, with just two assays, a panel had Area Under The Curve of 84%. This is also a detection of colorectal cancer versus healthy. We are delighted that our first finalized product grade assays are performing so well and look forward to reporting data initially from further small-scale studies and subsequently our large studies in addition to use of the dozens of other assays that are in our development pipeline. We are now stepping up work on these trials and we aim to have a lot more data to report in the coming months and quarters. We are yet again extremely grateful for the support of our shareholders. This has given the space to complete this fundamental work and allowed us to optimize so much of our platforms. It was vital that we went back to optimize the assays, so that we can move forward with confidence. In further news, in our fourth quarter of 2018, it was exciting to learn that not only put our Nu.Q technology help save lives and improve the quality of life of mankind but we are hopeful our technology will also be effective in helping diagnose a range of animal diseases. During 2018, we were delighted to present some very encouraging preliminary results from our proof-of-concept study using our Nu.Q diagnostic platform in veterinary medicine. The proof-of-concept study demonstrated that nucleosomes can be detected in dogs and therefore have the potential to differentiate cancer from other conditions in canines. Following the completion of some several small-scale studies in dogs, a subsidiary of Volition America, Inc. is now conducting a study in cancer and other diseases in cooperation with Texas A&M College of Veterinary Medicines, a leading U.S. veterinary institution. We hope this study will advance our plans to partner with academic and industry leaders to help expedite regulatory approval and product commercialization in this multi-billion dollar market. It is truly remarkable how much we care for and therefore spend on four-legged friends. In the United States, it’s currently the largest veterinary market in the world and has a clearly defined regulatory pathway by the USDA requiring fewer and smaller clinical studies than the FDA process in human diagnostics. This generally allows a much faster route to revenue for veterinary products as compared with human markets given the trials need to be in the hundreds not the thousands of subject samples. From a commercial point of view, we are extremely excited about the opportunity to offer Nu.Q VET test to animal owners and veterinarians. There are currently no accurate, simple affordable cancer screening or diagnostic test available in veterinary medicine and yet, 25% of dogs will develop cancer at some stage of their life. One very interesting fact that highlights this massive opportunity is there are significantly more cancer diagnosis of dogs than there are in humans in the U.S. every year with 4.2 million canine cancers diagnosed per annum compared to 1.7 humans diagnosed with cancer per year in the U.S. alone. Our preliminary estimate of what a diagnosis test would sell for in this market are approximately equivalent to what we would charge in the human market. So this is truly a significant opportunity that we will take very seriously and are moving forward with as quickly as possible this year with the aim of having the first product on the market in U.S. in 2020. As I mentioned earlier, Volition’s extensive intellectual property portfolio includes coverage of veterinary applications. We believe licensing this technology could not only potentially provide significant early revenue for Volition, but in addition provide further technical validation of our platform in human diagnostics. Our research and development team has grown significantly since we moved into our larger, purpose-built laboratory in Belgium in 2017. This has enabled expansion of our research and development program from our Nu.Q diagnostics test to not only include Nu.Q Vet as described above but our new project Nu.Q Capture. The Nu.Q Capture project leverages the work we have been doing to investigate the use of Nu.Q is only to purify or enrich tumor associated nucleosomes and therefore DNA. I am delighted to be able to announce that with our Nu.Q Capture, we have been able to deplete or enrich nucleosomes by 70% to 90% using magnetic beads in serum and plasma based on initial studies. The next step is to determine the level of discrimination of tumor-associated nucleosomes using mass spectrometry and/or sequencing. This potential breakthrough product aims to enrich tumor-associated DNA which in turn will help address the main technology barrier to DNA cancer diagnostic. Nu.Q Capture is platform-agnostic with the ultimate aim of providing complete nucleosome analysis and origin of cancer. To be clear, this is still very much a work in progress. But we have made significant progress this past year and our team is very excited about the potential additions to our platform. We are in the process of planning the path forward beyond on our ongoing CRC work in several areas such as this Nu.Q Capture, in lung cancer, most notably in Asia, and in our veterinary work in the U.S. We aim to be able to plot the path to early revenue with these focused areas of our platform in addition to all the work previously announced in colorectal cancer. As many of you may be aware, we are hosting a Capital Markets Day event in New York on April 9 at the New York Stock Exchange. This will be an opportunity to update investors and put more detail on our Nu.Q Capture Nu.Q Vet and lung work among other things. I am happy to say that joining us at this event to discuss this project in further detail is a newly appointed member of our key scientific advisory board, Dr. Axel Imhof. Dr. Imhof is a professor for proteins analysis at the Biomedical Center of the Ludwig Maximilians-University of Munich LMU in Germany and the Director of the Proteomics School facility of LMU’s Biomedical Center. Dr. Imhof’s lab is among the world’s leading groups for the characterization of chromatin-bound proteins and the characterization of histone modifications using mass spectrometry. He is also a Co-Founder of EpiQMAx, a company dedicated to the quantitative analysis of histone modifications in clinical samples. We are thrilled yet again to be working with such a renowned key opinion leader and I am sure you have enjoyed the presentation and so to future milestones. As many of you know, we have concentrated our research efforts to-date on colorectal cancer which is the most preventable and yet currently least prevented form of cancer and we very much look forward to completing our large co-clinical study throughout 2019, 2020 and 2021. In addition to our CRC studies, we are hopeful that our recent proof-of-concept results in lung cancer will be repeated in much larger cohorts and with additional assays currently in development, I’d hope to be able to provide details of these trials in the near future. Lung cancer remains the deadliest of all cancers and there is a high unmet clinical need for either a non-invasive early-stage lung cancer detection test and/or for test which can improve the specificity of low-dose CT scanning currently used in many markets. Our mission is simple, to save lives by revolutionizing the way disease and especially cancer is diagnosed. To this end, Volition is developing simple, easy to use blood-based test to diagnose a range of cancers and other diseases. Cancer is still a second leading cause of death and is responsible for one in seven deaths worldwide each year. It is the disease that touches and affects plenty of our lives, it is widely accepted that the best way of tackling cancer is for patients to receive an early diagnosis as this improves the chances of surviving cancer. We aim with our strengthened solid cash position to report throughout 2019 and beyond Nu.Q’s ability to detect a range of cancers including lung, colorectal, prostate, pancreatic, ovarian, head and neck, in addition to the 27 cancer studies and other conditions such as endometriosis, as well as data from both the Nu.Q Vets and Nu.Q Capture programs. I very much hope you can join us in person at the Capital Markets Day at the New York Stock Exchange on the 9th of April where we aim to be able to provide more details on Nu.Q Vet and Nu.Q Capture, as well as the pathway for potential lung products. In addition to Professor Imhof, we will be joined by associate professor Heather Wilson-Robles of Texas A&M who is collaborating with us in the veterinary market, as well as members of our management team all of whom would welcome your attendance and questions on our strategy and way forward. If you are able to attend, please do RSVP to mediarelations@volitionrx.com. We are delighted to be working with these collaborators and indeed all of our collaborators from around the world, all of whom have outstanding reputations and share our aim improving early diagnosis of cancer and diseases. We believe that Nu.Q will provide a low-cost, routine blood test that allows doctors to check-off an extra buff along with other routine blood tests such as cholesterol and PSA during a single visit and this is the only patented credible pathway to take implants with screening above 80%. We are extremely proud of the accomplishments we have achieved thus far and look forward to what the future holds for Volition. I, along with the rest of the Board and indeed the whole company look forward to sharing the results of key studies over the coming years with our optimized platform. We work hard every day to create a brighter future and one we hope any cancer can come together in the same setting. Thanks for joining the call today. I really very much appreciate it given the busy earnings call season. We are happy to take your questions. Operator?

[Operator Instructions] Our first question is coming from Mark Breidenbach of Oppenheimer. Please go ahead with your question.

Hey, Cameron. Thanks for taking the questions.

Thank you, Mark.

I was wondering that if maybe you could help the new data from the product grade assays into perspective for us. I am just wondering if the results you are seeing the Area Under The Curve numbers materially differ from what you were seeing with your research reagents. And I am also trying to get a sense with the colorectal data in your press release is that two assay panel, are those both Nu.Q assays? And if so, would the plan be to add more to just try and improve performance a little bit before taking the panel forward into a larger validation study?

Yes, very good question, Mark. I think a couple of things there. The results we have – we are trying to be conservative. So we tend to do bigger panels. We have done a handful of assays through these samples where the results were considerably better than we announced but with smaller panels in smaller trials, we want to make sure that we can reproduce what we are doing. So we only announced one or two assay panels which were, I think the very best single results we’ve got we are seeing much higher discrimination from these assays. Again to be conservative, we are running, we have a large medium trial in the phase that we need to see in that spots, we are very encouraged with what we’ve seen so far, particularly that because we have run the two lung trials and results were very, very similar. It’s very important to make sure you can reproduce the results in the second trial and just with those assays that we have run, we absolutely have done that. So, for those looking for background and AUC, just for order of magnitude of where we are, the only commonly used blood test is the prostate cancer test, the PSA and that’s a little over 70% and you probably ultimately with a very accurate exact test which is a little over 90%. So, to be in the mid-80s with these smaller trials is very, very encouraging. We absolutely have a lot more assays in development and some of the better ones – or a lot of the better ones we are still in the process of finalizing to the product grade. So we are very hopeful when we add those in, we will continue to see progress. But we didn’t want to announce panels of three or four with very high ratings that maybe not reproducible. So, we were conservative on advice from our advisors that we just showed the single assays, because that is by far the most reproducible or small panels. But I would expect the products to be three or four, but it’s very fair to say the accuracy is considerably higher than we were getting. But to be sure of that, we need to see it in the bigger trials. But it’s – yes, it was beating our expectations, that’s for sure. And you asked about the two in the colorectal trial, that was one in Nu.Q and one I Nu.Q the inflammatory marker which we are working on. We didn’t add too much data on the inflammatory marker that we run them in the lung trials, because it did put – or got high results. So we just want to make sure that specific and that we can reproduce that. So, overall, extremely happy. But we just need to make sure we do it properly and we run the extra assays we are doing, mutually dozens of new assays upgrading the old ones and then new ones. So, and it’s a steady stream now, now coming through. It’s a very vigorous process. It’s one which has taken us a lot of time. I think it’s very fair to say we probably pushed the products a little early year-and-a-half ago. So we raised the money to make sure that we can get all this very well done and expand into things like magnetic beads, which just that we got a couple of things, but we have a lot more assays. Also this is all on the very plain colorimetric readings which are – it’s our own platform. We are also looking at magnetic beads and chemiluminescents which are simple additions which could also help us in a lot of ways. So, overall, and make the platform much more adaptable to large auto analyzer machines and also has allowed us to do with Nu.Q Capture. So, I am extremely proud and happy of the background work we have done. This is just initial results. We dipped the toe in water, if you will and we very much like what we see and – but it’s very much – a lot more work to come through and we are very hopeful with the panel three or four, we could get a very, very good test. But that’s all in the process in the next few months as we do those many trials.

So, you would say in the next few months, you are in – it’s realistic that you would be able to announce the final panel, you would settle on what you required in the validation study. Correct?

That depends on the cancer. I think in lung cancer, the results were very, very good. I think, sort of a step-up even from the colorectal results we’ve had in the past. So, we just want to make sure that’s reproducible before we claim a product. So, around the Capital Markets Day or by the next Q, we are talking to several groups in Asia for large trials which don’t take very long to run. In China and Taiwan in the lung space and you are probably very familiar, lung is absolutely a tragic cancer in Asia even more so than in the United States, because of the air quality. So, it depends on exactly when the assays are completed. But we – I mean, the results we’ve had just from few assays are getting close to where you have to be - they are reproduced in the large trials. But we certainly have a lot of data. We are very hopeful for it. But we expect to have a lot of data in a very wide range of cancers and other conditions. And I guess, that will lead us to, we are very revenue hungry. We really want to make sure we get some revenue from our platform. So, the best way could be colorectal in the trials. We have – it could be lung in the trials where we have in the phase we are about to run. I think Nu.Q Vet could be a very big part of it. Absolutely blue water, very small trials. I am not sure it’s really here but dogs it’s a couple of hundreds to get USDA approval and there are many more dogs diagnosed in total than humans which is quite remarkable. So, we are really trying to thicken the pipeline to make sure we have a lot of data. We are not waiting for the U.S. trial first, the colorectal is something which is still reflecting and probably takes in 2021 and the Asian trials through 2020. So, we are trying to make sure that we really thicken it out to get revenue. I mean, we are in a very strong cash position having raised $6.77 million from warrants which is for us it was a extremely good quarter for that. A lot of people have concern that you have got another big dilutive event. If you add up the cash, we had at the end of the year plus the money that was raised in warrants it’s over $20 million and we are doing the $1.3-ish among. So we got a very long runway and really the warrants still outstanding which we’d be hopeful are exercised. All this gives us a really good pathway to get several of these outcomes most of them completed. But yes, the short answer is, we expect to have a lot of data in a lot of areas this year including colorectal.

Okay. All right, all right. One more from me, just on the lung diagnostic. I am just trying to get a sense of what you are envisioning its usage. Would this be more of a – type test to help rule out cancer in patients when something ambiguous or questionable paths up on their CT scan or chest X-ray before resorting to a more invasive biopsy or are you kind of envisioning this as a front-line screening in asymptomatic patients to determine who should then go in for a chest X-ray or a CT scan?

Yes, very good question and something we’ve given a lot of thought to with our Asian partners. What we are looking to do is the trial actually can answer both questions, obviously, a massive market and very quick to enter. Just for those of you who aren’t familiar with it. Low dose CT scans very sensitive, meaning they pick up a lot of cancers. But they are not very specific, if you are a seven year old smoker, there is probably some lumps on your chest which are not cancerous. So, the advice we are been given exactly as you say market is to add it to that to see if we can to specificity. And given the results, we are saying I think there is an excellent chance that could be the case and we are hopeful to announce a very large quick trial in Asia to help with that in the next few months. But I think we we’ve also got feedback from clinicians the other problem with low dose CT scanning apart from specificity is that compliance. Compliance, lot of people don’t want to the radiation, don’t want to go into the scan. So, we think we use before that it could also be a very big market to drive people towards what is the current screening test. So, you are actually right. They are the two options. We are entering trials to answer both those questions. I think before we saw this data, we saw it much more as a companion to low dose CT scanning which will be a massive market. But given the early results, and again it’s preliminary. We are doing a lot more work to make sure we can reproduce it. But it was very, very encouraging and that’s led us more to the opinion that perhaps it could be a front run test before the low dose CT scanning. And what we are aiming to do is to announce in the short-term trials on aging populations to answer both those questions. And I think it’s – we - I personally think there is a very good chance at the first and given the data we have a real chance for the second. So, stay tuned.

Okay. Fantastic. Thanks for taking the questions.

Thank you.

Thank you. Our next question is coming from Jason McCarthy of Maxim Group. Please go ahead with your question.

Hey guys. Thanks for taking the question.

Thank you. Thanks for your time.

Yes, so, regarding the Vet medicine in Nu.Q test, could you give us a bit more color on the market opportunity for that? Because, it seems that in Nu.Q, it’s a cost-effective and non-invasive diagnostic could be very attractive in this price-sensitive market.

Absolutely. We don’t talk about too much, because it sounds – I actually, virtually didn’t dropped, haven’t dropping moment when they told me how big the market is, because the veterinary markets there are 2.5 times more dogs diagnosed in the U.S. every year than humans and the market for diagnostic is – I think is very fair to say is – of the dogs, so we have lot of dogs that – because they just can’t work it out. So the feedback we’ve got we are working with – we aim to have a full view with Texas A&M in the coming months. So, that would be a great partnership. But the market is huge. And there is several ways of doing it. You can do what kind of a clear lab route which was the same as in humans and it could also the USDA and it could be done very quickly. You can get a USDA product in the market in a year, which is why we are hopeful for next year. So the market is billion. If you take 4.2 million dogs get cancer and there would be many dogs who get tested that don’t have cancer you’ve got to be far higher than 4.2 million a year. And if you are looking about the same process with humans, $100 or $200 it’s a very profitable test and again it cost us a very small amount of money to make that. Particularly, if it was our product grade assay, it looks like it possibly could be done in one, two or three assays. It’s extremely exciting. So, we are just being conservative again. We are going to the best groups we can which is starting with our pre-analytics to make sure dogs the collection is all done correctly. But it’s something we are really going to put a lot of effort with our collaborators in. And like with other things we are doing, it’s not a distraction, 95% of the work done is getting the assays for that product grade. Our four legged friends have the same nucleosomes as we do, which is quite remarkable. So, huge opportunity and I think it’s very fair to say a multi-billion dollar opportunity and one which could be a very quick source of revenue. The next step is to finish the pre-analytics which we are doing, collect samples in a few hundred dogs which we are hoping to do at Texas A&M and a lot of that work can be done this year and then go to the USDA with the first product which then can shipped worldwide. The USDA, once you have a product approved, it’s very much usable worldwide. And we’ve also discussed this not just dogs, we have also detected nucleosomes in horses. Therefore we could – we expect other animals as well. So, it could actually be in the short-term because the whole new human markets, because it’s a really uncrowded field and we spend the fortune on our best friends. So, it’s something we are very excited about and I think we’ll have a lot of news on that throughout the year.

And then just actually as a quick follow-up regarding that. Would this potentially enable earlier diagnosis? Because a lot of times with pets you end up – you don’t really know it’s cancer until it’s extremely late-stage and they are highly symptomatic?

Absolutely. Actually, interestingly, we are seeing broadly similar results than we have in humans. So, and we got to do more numbers. We are doing those trials now. But I think it’s a very, very strong likelihood that we could get early detection and a lot earlier, because most dogs are detected, well at all. The normal human processing, which don’t work well in humans, don’t work at all in dogs. So that really is a completely blue water field for us if we can deliver and I think that’s a good chance we can. And an interesting point also, some of our assays do seem to be pan cancer, which is difficult in humans to get approved by the FDA for obvious reasons. But in dogs, we’ve been told, if you are a certain type of breed, because of the in-breeding, you are much more likely to have certain types of cancers. So, the feedback we’ve got is there could well be an appetite for a pan cancer test for dogs, because I am not a vet. This is a thought we’ve been given that if a vet knows a certain breed has cancer, there is a very good chance they will be identified what it is by the breed, because of the very strong in-breeding in dogs. So, yes, something which we are very encouraged by and started by, not – I mean, we are very much pushing forward in all the colorectal, the lung, all the other cancers. But I guess, we got –a gift horse in the mouth. So, it looks like a very good opportunity and one which working with great partners could happen very quickly.

All right. Thank you. And then I just have one more if you guys don’t mind, actually regarding the Nu.Q Capture. So, since this is effectively enriching the blood sample for higher concentration of nucleosomes, would this require a larger blood sample? And then, also, how would this technology be applied down the line?

Yes, very good question. So, typically, one of the big problems with the DNA apart from not detecting early cancer, I mean, it’s a very wide field you gotten with billions and billions now, but they’ve always struggled with early detection. So, we are working through now. We’ve been working with the same volume. To get larger volume sample, you need to be on magnetic beads, because there is obviously a limit on the micro tighter plate for use 100 microliters. So we are scaling up to see if we do need more volume. We have been capturing nucleosomes on smaller volumes, but there is a potential need to be a larger volume if you are getting it’s thoughts by the DNA, if the actual DNA from the tumor might be as little as 1% of the circulating DNA. But I am not sure if I mentioned this before, almost all the DNA they capture for their DNA work is nucleosome balanced. So, there may be a need for extra volume, but if you think about, what we’ve always said, they are looking for a needle in the haystack. What we are trying to do is really sweep away the haystack. So we could provide a tool for other companies’ late-stage detection processes for therapy monitoring or perhaps provide an overall test. If we can capture nucleosomes and therefore the DNA, and really make it so that we can concentrate as quite a lot and we are not there yet, but we are certainly trying and I think we have the tools now to tell us if we can do it. It could really unlock the promise of the DNA process and it would be really fundamental to what we do. But again, it hasn’t been huge amount of work from what we do. Obviously, what we do is nucleosomes, the antibodies it’s been getting the platform on magnetic beads, so that you can capture them and in larger volumes. But theoretically, our platform now could do as much as a DNA companies in five or ten nodes if that’s necessary. Now we haven’t seen that’s necessary so far, but we may need that for more risk or early-stage cancers. So we are keeping all those options open. But it’s something which the team is incredibly thought it about because if this does, we can capture nucleosomes now and sequence them. If we can do less and show differences we believe, we see what happens, but it would be a massive breakthrough. So, we are on the task of knowing what that reflects in the next few quarters. So we are looking forward to reporting how that looks.

All right. Thank you very much and congratulations on the progress.

Thank you. Yes, we are happy. Thanks for your time.

Thank you. Our next question is coming from Bruce Jackson of The Benchmark Company. Please proceed with your question.

Good morning and congratulations on all the progress.

Thank you, Bruce. Thank you, very nice of you.

So, if we could just run through the pipeline here briefly. So, the test that was expected to be the first one was the confirmatory test, the colorectal cancer in Denmark the triage test. Is that still the case? And if not, can you give us a sense of how the assays might roll out?

Yes, we looked at – basically, we are under process at all the colorectal trials as well as the rest. So what we would try to do, while we’ve been doing all the background work on the assays, as we’ve mentioned getting their monoclonal, getting the recombinants, getting chemiluminescents, getting it on beads, all of those things. We’ve been looking for the quickest way to revenue and the short answer is we are never quite sure of what – we didn’t know the veterinary market even a couple of months ago with such dramatic opportunity. So what we are trying to do is really thicken up four or five things which can be used on the assays which come through. We never quite sure of what will work best from the assays which come through. Some assays work better in different areas. We were encouraged by the data we released in colorectal. I think that’s a very good start. That was a small trial, but it was prospectively collected in Belgium and which we published before and the results, that wasn’t the test for the triage because it didn’t have big positives. But the cancer detection was – as good if you could hope for in those assays considering what – just a small number. So we are in the process now of – we expect to have a lot more information by the Capital Markets Day and by the Q as to exactly which of these opportunities would generate the first revenue. But we are trying to make sure and triage is still very much a part of that. But what we are trying to make sure obviously these new assays in as many ways as possible as I said before, we are very revenue hungry. We want to make sure that we get revenue as quickly as we can. So we are layering in a lot of lung work which could be quick because of – if it’s – that could also be triage. As I discussed with markets with the low dose CT scan also the Nu.Q Vet work and Nu.Q Capture if we can complete that and show that we can discriminate, that would be a product and revenue in the next 12 months as well. So, the short answer is, we are working a lot of things. We are keeping the models on colorectal as they were and happy if it’s discussing your model, we can discuss after the goal on discuss through it in detail. But we are really thickening things out. We are going to fully stay ahead on the colorectal, but we are adding in lot of other areas too to make sure we can really make a difference to a lot of areas.

Okay. And then, in terms of the progress in the validation procedure for all of the Nu.Q assays, have you generated enough production grade assays yet to have all the components for any of the tests that you’ve discussed previously?

As I discussed briefly, we’ve – the AUCs are looking very good. We just want to make sure with just a few assays, and a lot of those assays in we were getting similar results from – for the panel. So, we are just in the process. We are trying to be conservative. It looks good. But we want to make sure in the medium size trials those results are reproduced. So where we are now, it’s – I think we are in the process of adding a lot more assays in the short-term they are coming up. The results are being very, very good and now what the panels look like, but I think, where we are going now we’ll hopefully need less assays in the panels than we were thinking most three or four than four or five or maybe even two or three, see how it goes. So, it’s good, but we are just trying to be conservative. But if we could put panels together with these three trials, we’ve done three smaller trials, but it looks pretty good. So we just want to make sure that we can replicate that. So we really, really talked about small panels now just so that we can be conservative and really deliver on what we are talking about.

Okay. Then, last question from me. You’ve had some of the kits available for research used through your partner. Have you generated any revenue off of those yet? And might we see any revenue from them during 2019?

Yes, absolutely. We’ve been – I spoke to my team last week, they have been selling. We sell through a few different groups that got one on the market now and the feedback is, they submitted just in that, but there is more we seen in the panel like we do, look for a panel of different histone modifications and we are expecting a second to be on the market in April and we expect to have up to half-a-dozen by year end. So, we definitely will have some revenue from them this year. But just trying to manage the expectations as I did last call, it’s not going to be a gutter. We are getting the royalty on some research kits. But it is validating by doing this. So, they are selling. We haven’t got the first royalty statement yet. But we are expecting that if we show how many we sold but they are selling. But I think we will get some real revenue from it or meaningful revenue once we have a profiling range of at least three, four, five of them which we expect to have later this year. So, the short answer is, we will get revenue from them this year. And we would expect to get a lot more revenue next year once groups start ordering large amounts of them when they can profile several different Nu.Q assays.

Thank for answering the questions and congratulations again on all the progress.

Thank you. Thanks for your time, Bruce

Thank you. Our next question is coming from Brian Marckx of Zacks Investment Research. Please go ahead with your question.

Good morning, Cameron. In terms of the…

Good morning, Brian.

Good morning. The anticipated larger confirmation trials for the product grade assays for the data that you announced this morning. Will the samples – the confirmation study samples include various stages of cancer and when you report that data, will you report by cancer stage?

Absolutely. So, all the trials we have make sure include early-stage cancers, because obviously that’s the all important and that’s where we really want – we want the best detection. Best detection relatively to anybody else. So, all the trials we will report, they just – we did have stage data, but they were small numbers in each stage. So, we were happy with what we saw, but we didn’t want to claim things which weren’t completely confirmable. So we are liking what we are seeing. But we will be doing the biggest studies this year. We will report the stages and that’s obviously very important for the product.

And then, in terms of the number of samples and timing of when you think you might have data for these next upcoming confirmation studies?

Yes, so, we’ve gone through the process. So we expect a lot of data in the next few quarters and again, it’s when really, it depends on which assays to finish in which order and there is a few coming through all the time. So, that will depend on, but what we are saying is, we expect information on the 27 cancers which is a medium to large study this year. We expect data on some colorectal trials this year. We expect probably the biggest, the first big data on the lung probably by year end, which is medium ones between. We are searching now, we have the prostate that we had fantastic data late last year, because we haven’t identified quite – which is the next step for medium to large trials in prostate. So we are very excited about that. We expect to have a lot of data in product trials for the – this year. Again, because you need one or two hundred and it looks like a small number of assays seems to do the trick if you will. And the – you got always together, there will be I think at least half a dozen data points this year. And exactly what order we have done in and the process will really depend on the data. But it looks, the things we are really pushing in the short-term beyond the colorectal one, the lung, because the great data we have got and the huge opportunity in Asia. The best side, because we can get a lot of data this year on product grade trials because if the USDA trials are few hundred and the Nu.Q Capture works. So, expect to see a lot in all of those.

Cameron, I was somewhat surprised to see the lung cancer data this morning and so, in the context of your priorities, I guess, it seems to be that previously lung cancer wasn’t necessarily a priority and it was more – your focus was more on CRC and prostate. Was there something that happen that maybe shifted priorities towards lung cancer?

Absolutely, we’ve – I’ve got back from Asia, three or four times this year and the markets there are growing massively to have a lot of money, regulatory process can be quite quick and I think every second question was, do have anything in lung? Do you have anything in lung, we can get them to market very quickly and make a lot of money. So, I spent time in Taiwan and in China and in Singapore and that was very, very commonly up. So, we did have early data in lung which was very exciting, which didn’t quite know what the pathway could be and a trial in the U.S. could be quite long and expensive. So we focused on the other cancers as you said. But, we are revenue hungry and we thought the Asian markets could be very, very attractive for lung cancer, because as you probably know, it’s out the lung cancer space and every cancer because of the air pollution and the air quality. So, we are hoping to announce pathways to early revenue in large trials in Asia for lung cancer, and a range of other cancers in the coming months and I think that will also be a very big part of what we do, because we really want to push revenue as quickly as we can in lung cancer in Asia. I think it could be a massive one. Colorectal was not as big there, because of the diet is quite as – and so, lung cancer was something which was just completely hitting us over the head in Asia. So, that’s why we’ve given in a focus and also then we did one small trial and the result was very, very good. So, we thought if we could repeat it in the second one and very much low. So, very encouraging.

So, the anticipated larger trials in Asia in lung cancer, are these anticipated to be retrospective or prospective or both? And are these samples that you already have or can have access to in a relatively short period of time?

Well, actually, we are doing some negotiations in this space on a range of different areas in that. We are looking to do a large trial in Taiwan and some trials in Asia and China. Part of the Capital Markets Day is to update by then or by the Q. So, next month or the month after. We’ve done a lot of work. I don’t want to say anything into, it’s all finalized, but we are looking for some retrospective. But also collection can be very, very quick. If you go to a lung hospitals in one of the big Asian cities, they might see a couple of thousand lung patients in a quarter or two quarters. So, you can get, very, very meaningful numbers in the sort of six month timeframe prospectively. All people with that low dose CT scan. So it’s something which we would really want to – if it goes well and we don’t know until we finish it all. We think it could be a big part of the story this year on announcing the trials and the first data. And a very big part of a product next year.

The Asian studies that you are referring to, these are separate from the Taiwanese studies from the University of Taiwan. Is that right?

Yes, we like Taiwan for couple of reasons. They are very good to work with. They are a Chinese ethnicity and we got some of the issues – sometimes have issues in China, but we are also serious about doing Chinese trials with the CFDA. So, what we are looking for is a very good group in Taiwan to help us with this and we are talking to them now. And then a group in China that can really help us launch products with a very good name and really get us, the rubber can hit the road quickly in China as well. So, we hope to have news on that in the short-term on both of those.

Okay. Thank you.

Thank you.

Thank you. Our last question today is coming from [Indiscernible] of Edison. Please go ahead with your question.

Hello. Thank you for taking my questions. Most of those already been answered, but I think, I wanted to think of one. You previously talked about – is this something you are still thinking about?

Absolutely, so, we’ve run a few of the product grade assays through this. We will be running some more. So we would expect data on that in the coming months. We haven’t done any analysis on this. So there is no update I can give you currently. We’ve been kind of – don’t want to miss all the data, now that the assays are where they are we will be doing a lot of different work. So, we expect to have time to analyze on that in the next few months and we would have data on that. But we don’t know if it’s going to work or not. But we have not analyzed that yet. So, that would be something which if the assays have been working, we should be able to announce in the short to medium term, in endometriosis as well.

Okay, okay. Thank you. And then, following on previous question about the research kit, do you know how many organizations have used so far your kits so far?

I expected to see if I would said it, as we haven’t got the statement, not to speculate. But they are selling, but it’s not – right now it’s not a gusher of revenue by any means. So, we are happy they are selling. We expect them to be a lot more selling once you have a more broader product range. But we haven’t got t he royalty statement yet. So, they are selling, but it’s not a meaningful amount of revenue. I’d be really shocked with a meaningful amount of revenue given that we are getting a royalty from it. So, we will make that public as soon as we get it. But they are selling and the feedback is, they expect to be selling very well once we have a – several of them we can sell at the profile like a lot of groups, like us, just having one assay and the research kit market doesn’t give you a profile. But there are some people buying them. Some groups buying them. But we expect it to really pick up once we have a range and we expect to have up to half-a-dozen by the end of the year. So, we would expect some revenue this year and well, almost certainly have revenue this year, because they have sold. And really start to pick up next year.

I was worrying just the number of organizations rather than the revenue, because I am aware that the revenue, we are not expecting that to be significant revenue, something like the interest from those organizations? And then…

We’ll know that soon and we will make it public, but yes, they are selling it, but I don’t know the number.

Okay, thanks. Finally, have you had any further conversations with any potential commercial partners in maybe in Asia for example?

Yes, we have. We’ve been talking to a few groups. There is a lot of interest in Asia as it has got in the lung cancer space and the other ones. So I’ve been back there quite a bit and our scientific team moving back and forth quite a bit. We are very ably led in Asia by Dr. Kway who has been doing a lot of work in Taiwan, in China, in Singapore and we will have lot more news this year as the pathway for those cancers and like the west work and the capture, we are seeing, these are very good additions to our product pipeline and we will absolutely have more news on that through this year. And it’s an area we are very excited about.

Okay, that’s all from me. Thank you.

Thank you. Thanks for your time.

Thank you. At this time, I would like to turn the floor back over to Mr. Reynolds for closing comments. Thank you everyone for joining us today for Volition's full year 2018 earnings conference call. We really appreciate your interest in Volition and look forward to speaking with you again in the near future. Thanks a lot. Good bye.

Ladies and gentlemen, Thank you for your participation. This concludes today's conference. You may disconnect your lines at this time and have a wonderful day.