VolitionRx Limited (VNRX) Q3 2018 Earnings Report, Transcript and Summary

Welcome to VolitionRx Limited Third Quarter 2018 Earnings and Business Update Conference Call. [Operator Instructions]. I’d now like to turn the conference call over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead, sir.

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 third quarter 2018 earnings conference call. I would like to thank you all again for taking an interest in Volition at this key time for us. In addition to myself Scott and David Vanston, our Chief Financial Officer join me on the call today. We have had numerous highlights this quarter with excellent progress being made on many fronts, showing the strong optionality of our platform technology. It is indeed a very exciting time for us. Initially I would like to focus on our key financial. I'm delighted that we have strengthened our balance sheet in two ways this quarter. Firstly and most importantly we closed a $9 million equity financing deal with a long term existing investor. Secondly, we secured additional non-diluted funding of approximately $700,000 from the Walloon regional government meaning that to-date we have received in excess of $3.5 million in non-dilutive funding from a number of local agencies in Belgium. Additionally in October certain outstanding warrants were exercised providing an additional $717,000 in cash to the company. So excluding these extra ones added is October, our cash and cash equivalents as of September 30, totaled $16.4 million compared to $10.1 million at December 31 last year. Given the expansion of our research efforts to bring these first products to market our average cash burn rate has increased slightly to approximately $3.9 million per quarter. We expect this to remain steady throughout 2019. Our cash position could be further strengthened by the exercise of outstanding warrants with exercised prices in the range of $2 to $3 per share that expire within the next 12 months and which if exercised could provide an approximate additional aggregate of $17.5 million in cash to the company. We believe that the above plus any additional non-diluted funding that we are able to secure and revenue from our sales our research kit puts our balance sheet in a great position. Now let's review our developments during the third quarter. Our focus during 2018 was in advancing the development of our clinical assays from the level of our past 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 this year that same [ph] has successfully completed a variable mountain of work to help ensure that our assays will be product ready. By that I mean analytically validated and of clinical grade so that they can be reproduced anywhere in any lab. This is a critical albeit time consuming step in the production development process. I would very much like to thank the team for their very dedicated effort. This massive critical work from our dedicated team is now becoming usable and is been used in a wide range of areas some of which I will outline today. Our product development follows a two pronged approach for the first prong we integrate all of our improvements into discovery grade assays that can be used in clinical trials and the publications. For example initial exciting data released this quarter in prostate cancer utilizing these discovery grade assays. These improvements include significant work on artificial nucleosomes something we believe was impossible even as little as 18 months ago. We have a number of trials underway in a range of different kinds [ph] and other diseases with these discovery grade assays and expect to provide updates in the next few months as we complete yet more trial. The second prong involves taking these discovery grade assays and further developing them to product grade assays including their robust needed for a long shelf life for all components to be run in any lab worldwide. These then can also be used in our research kit and in final product training and validation trials. This work has indeed gone very well with our team in a large in Belgium. However it is fair to say this development 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 nucleosomes and nucleosomics much of this work has had to be done from scratch. I absolutely believe we are taking the correct approach but it has delayed the achievements of our previously communicated clinical milestones with regards to the large product trials in colorectal cancer. Broader magnitude to describe the amount of work we have undertaken to-date each assay from the discovery stage to the product stage requires a minimum of 47 different experiments but sometimes over 100 and we are currently developing 48 unique assays. This work when completed for each individual assay is then useful in all of our future product trials. It’s 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 opportunities. After our strong intellectual property the most valuable asset a diagnostic company has is samples and in particular clinical study samples. Now we have assays in the final stage ready for products, a complicating factor has been that samples from various retrospective studies have been collected in number of different ways and so we're adjusting the process of rerunning our preanalytical studies before progressing to testing these assays in our large clinical study samples with finalized product quality assays. This work has been run before but we believe that it is very prudent to run again with our new clinical assays given how far our assays have come, how robust and reproducible they now are. Liquid biopsy involving sequencing of circulating tumor DNA is a rapidly advancing area with new entrants and used on a regular basis. Circulating tumor DNA is a success story for the investigation of the late stage cancer disease and for drug selection. However to-date circulating tumor DNA has not being a success for early stage cancer detection. You might be aware of a recent published poster and opinion piece from a significant proponent of this in the cell-free DNA space [indiscernible] incorporated which details the difficulties encountered in early stage detection using circulating tumor DNA alone. A brief summary of their finding is that the lower levels of mutated cell-free tumor DNA in early stage cancer patients means that cancer detection with circulating tumor DNA alone is challenging for practical, technical and biological reasons such as the needing a very large blood draw and will likely remain uneconomic for cancer screening in many cases without multiple order of magnitude decreases in sequencing cost. [Indiscernible] like others is the best path forward as using approaches that integrate their circulating tumor DNA mutations with multiple other blood base analysis such as ours. We found this to be an extremely interesting analysis from a highly credible source. We believe that this renewed focus on a other pricing markets such as nucleosomes and other inflammatory markers markets will make the work we are doing in Volition central to solving these issues. This is an extremely important development and expect to hear more from us on this. We have always been open to integration of orthogonal approaches to our test and have put a lot of resources into this area to ensure we get the best possible test. Our criteria for assays to add to our Nu Q platform are that orthogonal assays should be low cost and be able to run on the same platform as our new Q assays. In addition we have identified two low cost inflammatory markets which we found to be very useful in the detection of cancer. We've already announced some preliminary results from these in a discovery prostate cancer study involving men referred for prostate biopsy in Belgium. Just as a reminder the detection rate was 94% with both of these in inflammatory markers PSA and two of our new Q assays. With the new inflammatory markers greatly helping with the discrimination. We are also looking at dozens of other markets to ensure we have the most accurate test possible as long as they fit with our low cost routine blood test model. We could also announce now that we are applying for patent protection for these innovative novel inflammatory markers to add to wide range of intellectual property portfolio. Another recent scientific success story from our lab involves independent confirmation of our ELISA data our platform using mass spec in Germany we have isolated circulating nucleosomes in the blood and then applied mass spec to these nucleosomes. These experiments are at an early stage but we have found is that our mass spec results find the same histone modifications in agreement with our ELISA results. We believe that this is further scientific validation of our approach to cancer detection. We would like that this quarter to launch our first research use kit to be sold and distributed by our exclusive global sales and distribution partner for these kits, Active Motif. I can announce today that a number of these kits have already been sold to several research product groups around the world. In the first month it will be fair to say this is a trickle of revenue and also in the coming quarters as we had further product of this range we expect the additional offerings to generate strong growing interest in our products in the research and corporate community. I was also most delighted this last quarter just ahead of our last call to announce exciting preliminary data for our prostate cancer trial which gives us a further line in the water for a possible breakthrough product. As I mentioned just earlier at 88% specificity Volition's panel of five assays including PSA and two inflammatory markers identified 94% of high grade prostate cancers that require treatment according to the Gleason score method. This is a large improvement to the PSA alone which identified just 33%. Such excellent idea further demonstrates the potential breadth of our platform technology and if the results are validated in larger clinical trial this would be a very significant market opportunity. We are now working on how to secure larger prostate trials and look forward to announcing the development pathway for products in the coming months. We also recently announced this quarter the completion of sample collection in our endometriosis study with the very prestigious University of Oxford, England and we look forward to reporting these results in the coming months. In addition to our colorectal cancer work we are happy to confirm that we have begun analyzing the Bonn27 cancer study. This 4500 patient cohort has already collected by the University of Bonn, Germany and includes patients with the 27 most prevalent cancers. We aim to run all of our clinical grade assays through this trial as they become available. In the first of these is already underway. This 27 cancer study is very important and we hope that it will show the breadth of our Nu Q technology and help direct our further development of our Nu Q test and have the report on cancers, notably lung, pancreatic, prostate, gastric and ovarian to name but a few. We expect to report preliminary data from the Bonn27 cancer study in 2019. 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 commercial product and/or licensing our assays to a range of other organization that are experts in individual cancers. Yet another application of our technology that we announced this quarter is our expansion of our Nu Q new trials through veterinary diagnostics. We presented proof of concept results at the 10th anniversary meeting of the Belgium Technology Mission at Texas A& M University. The study demonstrated that nucleosomes can indeed be detected in dogs and more recently I can announce we have completed the study with similarly exciting results in the horses. Our initial focus remains very much on human diagnostics so we're delighted to be working with an experienced consultant in the U.S. veterinary market, Nathan [indiscernible] to find the business strategy and foster key relationships necessary to launch the commercialisation process in this market. We aim to announce further developments and key collaborations about this possible application over the coming months. Such progress really helps highlight the strengths and broad application of our Nu Q platform technology and we firmly believe that this delivery of a product in any one of these areas would have a significant impact on the company's success. Further from a clinical trial perspective we were delighted to announce the signing and commencement of recruitment to our two Asian trials in collaboration with the National Taiwan University. With the lead principal investigator Professor Han-Mo Chiu, by a way of reminder the first trial would be a large scale study in the Asia Pacific region including 5000 asymptomatic colorectal cancer screening subjects and a second trial will include up to 2000 symptomatic colorectal cancer patients. These studies are been conducted to test and validate Volition's proprietary Nu Q platform for the detection and diagnosis of colorectal cancer for marketing, rights [ph] and regulatory purposes in Asia. These multi-country, multi-center and multi-ethnic Asian cohorts, our addition to the approximately 45,000 European subject cohorts and the 13,5000 U.S. subject cohorts that are already part of existing studies and further demonstrates Volition's commitment to commercialize its Nu Q platform globally for collaborating with world renowned institutions and key opinion leaders. Professor Chiu recently visited our R&D facility in Belgium, a video of which was featured in our press release last night. In fact in addition to the Professor Chiu visit video we released a number of videos this quarter that help bring a lot of what was discussed on these calls live. I urge to watch them. Once okayed our facility and included interviews with a number of our team members and a second video features interviews with members of our Scientific Advisory Board, this SAB is a multi-disciplinary international board with expertise in a broad areas of technology and it meets at least twice a year in person to provide high level advice and to counsel our scientific team. I would like to publicly thank the members of the SAB for the invaluable insight and input they provide which in turn helps out drive scientific rigor throughout the organization Our SAB has also provided us with very good feedback into the use of our assays in plasma as well as serum, why is this important? To different and both very common ways of preparing large serum and plasma. I'm very happy to announce today that work is well advanced on our first two assays been optimized in plasma as well as serum for our trials and for the research market. Why is it important? This will also mean we can run trials with circulating tumor DNA companies who solely work in plasma. Going forward we have now a policy for all assays to made for both serum and plasma. I was starting to recommend anyone interested in the company watching our videos as I can bring what we do to life and provide further in-depth analysis on many levels and so to the upcoming milestones for the remainder of 2018 and into 2019. We aim to report data for both the triage and the front line colorectal cancer screening products which will be finalized once we have the preclinical assays and the pre-analytical work completed. Our large U.S. and Asian colorectal trials are also in the process of collection. Following our extremely exciting early data we are also working hard to secure a large prostate trials and look forward to announcing a development pathways to commercialisation of products in the coming months in prostate cancer. We expect to generate revenue from the sales of our research kit from Active Motif and as we continue to add-in further products to this range to ramp up sales through next year. To be clear we think having a large number of researchers and companies will greatly add the validation of our Nu Q [ph] platform however we would expect much more significant revenue to come from the sales of clinical products we are developing rather than just as a recent products sales of which we expect to commence next year. We also expect to add a mid-sized U.S. colorectal study to give us data in U.S. population before our large EDRN study becomes available. We hope to further develop our veterinaries product strategy in conjunction with receiving data from trials involving the three most prevalent dog cancers and also to broaden this into horses as well. In addition to our work in colorectal cancer and prostate cancer we aim to report proof of concept data on the validity of our platform technology from other trials such as the Bonn27 cancer study and the endometriosis study mentioned earlier. And lastly but also importantly we plan to further strengthen our intellectual property portfolio by taking additional key patents in several countries including the U.S. I've said it on many calls before but I'd like to say it again, it's the people that make the difference and I would like to sincerely thank our visionary team for the very significant progress we have made this quarter on so many fronts. It has very much been a building here with a massive amount of work underway and completed. This is not an easy thing to convey to the market but it is critical if we are to be successful in our goal to revolutionize cancer diagnostic. We are extremely excited and optimistic about the coming months. Like many of you we will be in San Francisco for healthcare week in early January and we would love to see you so please get in touch with us to book a meeting. 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 our Board and indeed the whole company look forward to sharing the results of our case studies over the coming months and quarters. We work hard every day to create a brighter future and one where hope and cancer can come together in the same sentence. Thank you all. Operator?

[Operator Instructions]. Our first question comes from Jason McCarthy with Maxim Group. Please go ahead.

If would like if you could give us a quick walk through of some of the ongoing studies and then just the next step in timelines for development of Nu Q and CRC in particular for registration in Europe.

Yes good question, Jason. So we have been in colorectal the triage process, so the triage and front line test we've been waiting for the final work to be finished on the clinical assays and we've started I think as well I mentioned on a few calls to make sure that they are absolutely as good as it can be possibly be. Now that we're very well-funded and we have the lab and the team we want to make sure we get it 100% right before we run those very big trials because if you get sold the product and we wanted to make show it's perfect. So that's all in price and we'll have those during 2019 exactly when in 2019 well its earlier like depends on just finalizing these preanalytics but and the assays themselves but it's fair to say we have cracked the assays. We have got the process now to get them into the final stages just going through to get them all done which is exactly what we're doing. The path way for prostate we're looking for trials in Asia, Europe and the U.S., the data was fantastic its potentially a multibillion dollar market it’s a result of hold up so we're talking to a few big groups in the U.S., Europe and Asia. We expect to have news in the short to medium term which would be a pathway to getting the product worldwide and the good news with prostate and triage they only take a couple of our assays to be ready—so that will be ready before the frontline because there is not too many assays to get to that final stage for that product. The veterinary work is a much quicker process because it's in animals and also a massive market and I was very encouraged that we also showed good data in horses as well as dogs. So we're doing this very similar work to what we're doing in humans so far as getting the assays optimized for the animals as well as the pre-analytics to make sure they are collected properly and that's proceeding well. We aim to work with a small number of institutions to get those trials outlined and completed, they are smaller trial you're looking more like a 510(k) in the PMA humans or equivalent, a few 100 and it's a massive and dire market, I think I mentioned before that we have diagnosis in animals and is even worth it in humans so I think that could happen a lot quicker than the human trials because of those reasons and you can also use retrospective samples and it's just a lot quicker process. So far as endometriosis we're actually now we're the running the discovery grade assays through that now so that could be very quick. I expect that in the next few months and it's something which we will see how it goes, it makes perfect sense it'll work well you don't know until you have run the trial so that again it would be an absolute blockbuster if this trial comes through very well and we expect to have some information on that quite soon. The Bonn27 we're just working through that's not really a product trial that’s more background work in the other cancers and we're done a lot of work on the concentration of DNA from tumor origin which could possibly help the DNA companies as we discussed. So that that could happen sometime in the first half of next year if it does happen we don't know we're working on that now it's promising but we're not there. So with those alone I think one thing to be 100% up front we have been bad and know exactly what order things will be completed. We thought for example the triage would come out for the first prostate data but obviously the prostate data came out was fantastic. So it's very hard to know exactly which order they all come in but there's a huge amount being done it's all in the same platform and we're very, very encouraged but we're making sure because we're funded we get it absolutely right so we're doing everything and just double checking, checking everything because once you start the product trial you can't tweak anything. So we're just making sure it's all exactly as you want it before we start but all of those we expect to be coming through in 2019 and some of them quite quickly.

All right. Thank you and just one more on thought he RUO kits [ph], could you give us a bit more detail on what would be like the key factors for driving growth in that area and then just who is the target customer for these kits and what kind of applications allow them to best leverage to nucleosomes [ph] technology?

Sorry I missed the first couple seconds of your question. Can you repeat that please? Those kits?

I was just saying that the RUO kits if there are any key factors or events for driving growth in that product?

Yes, very much so. I think like everyone else we started with a total nucleosomes and we have a very wide range of other structures on the nucleosomes so I think what would drive growth there is a couple of things the more people publish with our research kits the more background work done and more people will use them. Also as we develop more and more in the range of research kits we expect to have a lead top a dozen on the market by Q1 where we have one now instead of buying one they can buy range with them, also we're talking to a range of potential collaborates in different spaces who can buy that numbers of kits and that's the process of which we have been in the process of but also some research groups also applied for grants and of course that takes a few quarters to get a grant once you apply for it or even 6 months or longer to get the grant applied for. So I think the general drive is that epigenetics are becoming very important in a lot of different research areas as well with genetics as genetics are with the DNA. So I think as we add more products in the range as they become more and more well-known I think they'll become they will really start to take-off and I think it's fair to say within a year or two we should have dozens of different profile kits on the market and that's been I think would really, really take off. So you will see at the end we will report the numbers and similar kits when we report at the end of the year but there has been interest, we are filling kits and we expect it should pick up through next year.

Our next question comes from Mark Breidenbach with Oppenheimer. Please go ahead.

Hey, guys this is Matt on for Mark thanks for taking my question. So [indiscernible] question on timeline and Cameron I appreciate the massive undertaking that transitioning the product great assays amounts to you but I'm just wondering if you could kind of give us a firm timeline here. Do you still think we're on track for an early 2019 undertaking of the 4300 sample training study as well as finalization of the Nu Q triage and frontline screening panels or do you think this might be more of a later 2019 event and I've a follow-up.

I think that there is a very good chance we could have a follow up trial in prostate and triage in the first half of next year because its only few assays and we've got quite a few of them -- those few are very close of being done and done that’s probably different but I think for the frontline test it's probably to get the number that we have to get done as well as we are just checking all preanalytics just to make sure that there's no difference in the trials. The frontline test probably is the second half but the triage, prostate and endometriosis and a pathway in veterinary and prostates would be something which I'd expect in the first half of next year or even some of them later this year. But the actual frontline trial is taking a lot of work to get all assays to the final stage. So I would say that would be a second half but the first half of the triage and hopefully the next level of the prostate and then endometriosis and all the other things we are doing.

And my second question is kind of two parts, so by my tally in addition to colorectal Nu Q have shown some really compelling early data in prostate, lung and pancreatic cancers as well as an endometriosis. So now under the pretense that resources are not unlimited. How does the team decide which indication to pursue next and the second part of my question is when do you think we might see an announcement on which indications should proceed next?

Yes, a very good question and something we obviously do a lot of thinking about. We went on call record first [ph] purely because it's good gold standard in the colonoscopy in the process I think prostate is extremely compelling because there's absolutely nothing out there and it means for the question we are answering which is a multi -- it’s a fantastic question, it’s a huge problem for clinicians I think beyond that we had very good results in pancreatic and we do have a trial in the freezer for pancreatic. I think the BONN27 cancer study will have a good read out by the first half of next year in a range of different assays should give us a good steer on which ones to go next and I think that to get we're also broadening it's not just the cancers but the countries I think Asia will also be a very important focus for us. So just for clarification we haven't released any data in the endometriosis as we had some very small indications and it's a fantastic idea and it makes perfect sense but we don’t have any compelling data showing endometriosis does work. We are in the process of these trials which we hope will get us to the point I think in large numbers with Oxford but at the moment we would have to say it’s a strong educated guess not a good data. So it's something which we tackle every day. I think obviously you start with the major cancers and you ask for major questions, so the next one we'd like to propagate if we have any results in would be lung cancer. We had good results before but I think that's one we take off the rank next. I think beyond that the other major cancer which is obviously a massive problem with breast cancer but I think the next year the colorectal triage front-line and pancreatic will be the big one and most of these one of the other ones come out of nowhere but results wise I think what is extremely important for us is it is a platform technology 95% of the work îs getting through product to market is getting the assays to this starting line, running the trials is actually reasonably trivial compared to the all the work we're doing on the assays and once it we have done the assay work once is then good for all the different trials, work in every trial, different essays work differently in different cancers we think but the work is done and we don't have to do it again for research kits or in [indiscernible] plasma or in anything else. So it's a big platform and now that we have assays working in plasma we can also work with the DNA companies. I'm sure you know them all because I think what I discuss on the call I think it's very fair to say they struggle now to find the tumor DNA in early stage cancers so I think we can be help in a number of ways including concentrating the DNA and providing affordable markets for them too. So we will see if that does come to fruition in 2019 we could add those sort of trials on to what we do as well.

Our next question comes from Jonas Peciulis with Edison Investment Research. Please go ahead.

So on veterinary given you are pushing more actively on it, how should we think about that potential timeline? We are probably sort of aware of what those take sort of development [Technical Difficulty] what is evident there in the veterinary again, general how [Technical Difficulty].

Very good question, Jonas and we thought about this quite a bit. Obviously it's not something we are expert at in any way so we are working with few groups a consultant who I mentioned on the call who's providing us with very good strategy on how to get there and also with a very big university system in the U.S. because we've asked them what are the clinical questions which are most important and which animals. So the path is actually much, much quicker than in humans. We do take care of animals so it's not just you can't just put anything out there which is exactly the way it should be we care for our best friends, but it is much, much quicker than in humans for a couple of reasons you can do a trial more if you think about we're looking from the U.S. FDA perspective in humans it's much more of a 510(k) which means a few 100 patients, I'm not sure we call a dog a patient, a few 100 samples or a horse and to show that it's working in a horses as well as dogs now is really encouraging and the size of the market actually when I first saw the numbers I didn't quite believe them how big the veterinary market is, it's absolutely huge. There are a few big players in the world so it's very plausible it's a 2019 story, it continues to go well where we do a large trial and we get to the point where we can define what the product is and the exact timings of the launch and the work but it's not something which will take 2,3,4 years like in humans, I would expect it to be orphanage in the next 1 or 2 years because it's a few 100 samples but we're starting with the analytics and the assays development to make sure they're applicable for dogs and so we are definitely starting from humans because they are slightly different but it's very encouraging I think it could be an absolute massive products and as I said before a dogs diagnosed worse than humans so it's something which could really take off very quickly compared to everything else because there are samples collected, it's a massive market and there really is nothing out there which works well in animals at all so we are very excited about the prospect and we are taking it very carefully but as quickly as we can.

Okay. Thank you. That's helpful. My second question is on the endometriosis [Technical Difficulty] progressing difficult to diagnose, difficult to treat conditions and specifically I was thinking about why it's difficult to diagnose [Technical Difficulty] just diagnose alone. So you know from that perspective any kind of you know non-interventional diagnostic probably would be easier to bring to market just because it’s a number games specific to -- it should be you know less complicated so thinking what be proof of concept or any evidence in order the technology to be actually you know applicable condition?

Yes, we had very good question just a couple of things on your introduction very true. Currently its diagnosed upto 8 or 9 years after the onset which means about 50% of female infertility comes from endometriosis so it's absolutely shocking to these and its uses is covered quite especially women now have babies later in the Western world it's appalling, it's painful as I said makes a lot of women infertile and is very, very badly diagnosed setup to 8 or 10 years typically. So if there isn't a blood diagnostic it would actually probably bigger than the cancers because it would be given to every girl of about 16 or 18 years old and not just older people like cancer. So it's potentially massive. What indications? I can go -- we're gone through publicly, we've done some small trials which were encouraging but we didn't have exactly the right time point because the basic idea is testing it at two different time points in the menstrual cycle so we could do it in aggregate so it's encouraging but not definitive but the actual concept makes perfect sense that the endometriosis grows in strength on the menstrual cycle and instead of being discharged the menstruation goes into the blood. So it's perfectly plausible that women have different levels of nucleosomes in their blood at different times in menstrual cycle which is what we're measuring. So it's similar to a cancer in that respect it's still there, but we're measuring in nucleosomes just for a different reason but fits in very much with what we're doing, makes perfect sense. We have not proven that this is the way to go but if it is going to be proven we could be very close to it because we now have the samples, we now have the assays which we're very comfortable with, they are robust, they are reliable and linear and so it's something which may not work or if it does work we could know it in the very short term or short term once we finish this trial and it would be an absolute blockbuster if that's the case probably a scientific team we've done some market analysis but not too much and we've got through this stage but it would absolutely be as big as a cancer and would be a company maker in itself. So we're encouraged but it's not definite, a definitive but we should have something definitive either way in the next quarter or so depending on how we finalize the trial with those assays but we are getting close it. It's being collected now for 3 or 4 years so it's been a long time in the making but it's coming to hit.

Our next question comes from Bruce Jackson with The Benchmark Company. Please go ahead.

Yes, it's a big task you know to get all of the assays up to product grade but maybe you could like give us a bit of this ability on the development pipeline, so you've got 48 assays that you are working with. How many of those are currently at what you're calling product grade.

We've gone through the process, so yes it's 48 coming in and to get all of those we have to have the antibodies, we have to have the common nucleosomes. We haven't really -- I don’t do it week by week but I know that there's at least 14 or 15 or something in the discovery grade and there's a few that have come through to the final product stage, I don't have exact numbers but it's less than the discovery grade. So they have got it done with the practice but they're still working through those that's why we haven't run the big trials because they just haven't made been enough but the couple which have been done a very close to being done the ones which work very well in the prostate and very well in a smaller triage study we have done before so I think those can become quickly. We haven't really phone numbers and we don’t do a running tally week by week part of this commercial as well as scientific but what it means in practice is by end of this year or early next year we'll definitely have the ones ready for the prostate follow-up and the triage and probably more mid to the end of next year before we have enough done to do you need a good dozen to 15 to finish up the colorectal trial trollop up and that’s not where we are right now but it will be a process through that system but from endometriosis for example we are using discovery grade assays so there is plenty for that trial and also for the veterinary process discovery grade assays so there is plenty for that trial and also for the veterinary process discovery grade assays because they are been run in our lab so it will be a process coming through but the team have absolutely cracked it, it’s a process now going through them all but its been a huge amount of work and I think I mentioned on the call just to be clear we are also testing the preanalytics as well as you probably know there is a big difference between serum and plasma and all the different collections and now our assays are as good as we can possibly get them the ones that come through the system. We're just running the preanalytics again just to make sure the trials all that we're comparing apples to apples of every single trial. So that’s all been done now. And we got a very strong advice from our Advisory Board and from the people funding us to make sure we get everything absolutely right because we don't want our launch product and have something that we could have done quite easily and not done before pull the trial because after it's impossible to fix it very easily but at the moment any of these things which can be tweaked, can be tweaked now and very easily but that's not a huge amount of work it's going very well.

Okay, great. And then if we could talk about the inflammatory markers a little bit so it's an area that's important to you on cancer detection but it also covers a lot of territory so you have got pretty big group of [indiscernible] etcetera, can you give us a little bit more detail on what area the inflammatory markers here you are focused on?

Actually I can give you generalities I am not a scientist and being with patenting, it hasn’t been used in this way before so we do have intellectual property being applied for as we speak, but I can talk generally in how all this fits together. If you read this the opinion piece that I mentioned and the recent work that they have done they think that the DNA is quite minimal but there's a lot of inflammatory markets which comes from the cfDNA and I think that what we've realized amongst everything we're doing is we are very closely linked to the DNA so far as the DNA they are after is all nucleosomes bound, so for all of that we start looking at some other inflammatory markers in a different kind of way in a way you are just doing what we are doing and yes it has been excellent because I think obviously the nucleosomes from the tumor and its also inflammatory nucleosomes from other things around it and other markers which can help you get there, so I think we'll have a patents talk about in the very short term we can perhaps overtake I think can fill you in with the public at that stage but so far it's been a very good marker and really hope we are doing. So as we spoke about before we are a nucleosomes company but we're not above using anything to help us get that extra little oomph to get the test as accurate as possible and we're very encouraged with the work we have done on some of these other markers because we've found some which are very helpful. That’s as much as I can answer today but I think in the next month or two or at JPMorgan you sit down and I think but at that stage we would have patented all the things we are trying to do on some of these areas and he can probably give you more depth on it.

[Operator Instructions]. Our next question comes from Brian Marckx with Zacks Investment Research. Please go ahead.

Based on just a question regard commercialization timelines it sounds like based on your prepared remarks that you still do expect to commercialize a proprietary Nu Q test in 2019 but given the delays to triage and the front line is that still something that you that is doable in 2019 you think in Europe?

Sorry I missed the second half of your question, I think you asked is it still possible likely we're going to product in 2019 is that what you said Brian?

Yes.

Yes, as we said we are practically working through those now. I think we'll have fantastic absolutely tip-top shaped assays which are linear reproducible above all those things for the trials, as I said we are just doing some of the preanalytics again to make sure that’s all good and to make sure that all the trials are valid from that point of view and then we'll start them. So I think we will start them so I think it's very plausible in 2019 exactly which one you are never quite sure depends on which assays and fits in what order and how many they need but I think we've got works really coming to a head now so I think that's absolutely a viable proposition in 2019.

And then in Asia do you think that’s viable as well to commercialize next year?

I think it's possible for I think because they are collecting now as I said the Taiwanese they are collecting for us in the colorectal space but that collection will be next year so it will be 2020 before that comes through for the colorectal space, and if there is a retrospective prostate trial we get going in Asia that could -- we could have a very strong pathway and a the product defined in 2019 but would not launch in 2020 and I think veterinary would be the same. I think we can define the pathway and the product next year to launch in 2020 and the U.S. given as a reminder we are collecting massive trial with ADR [ph] in which we expect to be able to launch product in 2021 as well. So I think as we meant about what I talked about 2019 a massive amount in 2020 and then we would expect the U.S. in 2021 which would also I expect to be by that stage we had the prostate if it continues to go well perhaps [indiscernible] that’s going well as well and the colorectal in 2020-2021. To reiterate, the vast majority of time if and all of this running the trial is going to take next years a lot of work, a huge amount of work is getting these assays to the final stage because there is quite a few and lot of structures which gives us tremendous optionality in everything we do but once you've done that work it has to be done once for the assay and then the assay can be used in a huge range of scenarios.

Our next question comes from Jay Albany with SeeThruEquity Research. Please go ahead.

Thank you for taking my question. Many of my questions have been answered actually but I missed something I was hoping you could refresh us on the timing for the upcoming prostate?

Yes actually well we haven't -- we think it's very exciting data and we're going to get the assays finished, there can be a product trial not a research trial for that. We haven't announced exactly what that pathway we will use yet, we are in active discussions in a range of different areas and different countries. So expect to hear that in the coming months exactly what the pathway is for that but we have an outlined the pathway for the next level of the prostate but it's something which could take a lot of -- speed up a lot because as you said the delays in the colorectal side are been getting the assays to the starting line if you will where this -- the panel of works very well with only two nucleosomes and the ones between that were either ready or very closed to being ready so it could really pick up next year but we haven't -- one of the things we were announcing the short term is the pathway to get to a prostate product but we haven't done that yet.

I also just had a follow up, could you refresh -- did you say you have some I guess data or information on what your plan is for endometriosis in the next few months is that what you said in terms of timing?

Yes, we have two trials the big one from Oxford University and a smaller one with the group also here in London which is flooded with information, both collected, both in our freezer both are been basic run now so whether it's [indiscernible] Q1 depends on the finalization of it it's the last assays but we are close to getting a response from all of that. So expected to do that in the short to medium term either at the end of the year or early next year in Q1 that's what I'm expected to see all and we are very hopeful but we don't know until -- yes I know the discovery assay so they can be run on a wide range of things now which is -- this is not a product trial this is a proof of concept trial. So it can be quite quickly to come out, but for the same reason everything else the assays if it does work the assays which we use in that are the same essays we are trying in colorectal so the product could come quite quickly after that because the work has now being done on that, or will have been done by that stage on all of those FAs to make them a clinical assay. So it's all really picking up speed.

This concludes the question and answer session. I would now like to turn the conference back over to Cameron Reynolds for any closing remarks.

Thank you. First of all I would just like to say the volume skipped a couple of times so we would expect to see a transcript of the prepared remarks online afterwards but there was I'm not sure every my study [ph] skipped and thank you everyone for joining us today for VolitionRX's third quarter 2018 earnings conference call. We really appreciate your interest in Volition and look forward to speaking to you again soon. Thanks a lot. Bye.

This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.