Scott Powell - Director, Investor Relations Cameron Reynolds - Chief Executive Officer

Brian Marckx - Zacks Investment Research Jan Wald - Benchmark Company Bruce Jackson - Lake Street Capital Markets Jack Lasde - Morgan Stanley Menachem Kranz - Ahava Investment Partners

Please standby. Good day. And welcome to the VolitionRX Limited First Quarter 2015 Earnings and Business Update Conference Call. Today’s conference is being recorded. And at this time, I would like to turn the conference over to Scott Powell, Director of Investor Relations. Please go ahead, sir.

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 three months ended March 31, 2015, along with the discussion of our key 2015 milestones to-date. Following our prepared remarks, we will open up the conference call to a question-and-answer session. On our call today are Mr. Cameron Reynolds, Chief Executive Officer of VolitionRX; and Scott Powell, Director of Investor Relations. Before we begin our formal remarks, I would like to remind everyone that some of the statements on this conference call maybe considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statement. Words such as expects, anticipates, intends, plans, believes, seeks, estimates, optimizing, potential, goal, suggests and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the company's bodily-fluid-based diagnostic tests, as well as the company's ability to develop and successfully commercialize such test platforms for early detection of cancer. The company's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include the company's failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in the company's development pipeline or any other diagnostic products the company might develop; the company will face fierce competition and the company's intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in the company's most recent annual report on Form 10-K and quarterly report on Form 10-Q, as well as other documents that the company files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about the company's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this conference call, and except as required by law, the company does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances. I'd now like to turn the call over to our Chief Executive Officer, Mr. Cameron Reynolds, who will discuss the first quarter of 2015 and our clinical and operational objectives for the remainder of the year. Cameron?

Thank you, Scott. And thank you everyone for joining VolitionRX’s first earnings conference call. I would like to thank you all for taking interest in Volition and this is very exciting time for us and really appreciate you taking interest in our company. The first quarter 2015 was very significant for the company. On the capital market side we listed our shares on the New York Stock Exchange MKT market on February 6th, simultaneously closing a $10.6 million while listing in a fully registered offering of our common share, through which we had many new retail shareholders and several key institutional investors. VolitionRX now has sufficient cash to take us well into the second half of 2016, by which time, we should have release substantial amount of clinical data from several of our ongoing clinical trials and have European Regulatory Approval CE Mark. We ended the quarter Q1 with about $11 million in the bank. Being listed on the senior U.S. Exchange also broadens universal investors able to purchase our shares and further increases our visibility and credibility in the capital markets. This listing also provides us with the stronger platform through which to access the capital markets and should continue to increase the liquidity of shares in the market platform. Turning to our clinical developments, in Q1, it was extremely important one for us. In January we announced the pilot study in collaboration with the Singapore General Hospital to provide initial evidence of our NuQ assays ability to detect early-stage ovarian cancer. We release results from our pilot study in pancreatic cancer. In the 60-patient study conducted in collaboration with the Lund University in Sweden, which comprise 25 early-stage treatable IIa and IIb stage pancreatic cancer subjects, 25 healthy subjects and 10 subjects with competing additions of the pancreas. Our NuQ blood assays based diagnostic platform accurately detected 84% of these early-stage pancreatic cancers with only a low 8% false positive rights. These are extremely exciting results as there is currently no commonly used accurate screen available to detect early-stage pancreatic cancer. This is now the fourth cancer in which our blood-based screening technology has accurately detected early-stage cancer and provides -- conducting larger trials in the pancreas -- pancreatic cancer to further prove our technology. Similar to what we have done in colorectal cancer. We expect to announce one or more large clinical trials in pancreatic cancer near future, which we are hopeful confirm this promising early initial results. In addition, we are pleased with the February acquisition of the early non-core patent family that VolitionRX did not own our right. But which we did have exclusive world-wide rights too. The patent family WO 2005/019826 was co-right from U.K.-based Chroma Therapeutics. This further strengthens our position in the inspection of cancer which is based on the detection and measurement of chemically altered nucleosomes structures in circulation. This acquisition brings our portfolio pending and granted patents to 10 and further increases shareholder value by bringing in-house our royalty-free access to this patent and it’s the only key patent related to our Nucleosomics Technology that we did not own our right. In April, we also announced a new 800-subject clinical trial with the Hvidovre Hospital in Copenhagen, Denmark to establish whether our NuQ test can detect pre-cancerous colorectal polyps, which are also known as adenoma. We have shown in one of our colorectal studies that we’re able to detect up to 60% of pre-cancerous polyps. But this will be our first trial, specifically looking at pre-cancerous by themselves. These will also be processed on one of our new Tecan robots. Finally, using the portion of the price we use from our -- February financing, we announced the best of three further Tecan machines or laboratory automated systems which would significantly expedite the rate at which we process samples from our ongoing clinical trials. Once these three Tecan machines are fully operational by the end of May, and in conjunction with our existing Tecan machine which is how it worked at the moment, our processing capacity is expected to reach 30,000 samples per month, which for order of magnitude is approximately the total number of samples that VolitionRx has purchased in the entire five-year history of our company manually. The rapid processing of samples should ensure that we released a significant amount of capital data in the second half of this year 2015 in several of our ongoing trials and should allow us to more quickly move our products through the regulatory process and into commercialization, which is of course our ultimate gain. Looking ahead to the remainder of 2015, we have many important clinical and commercial milestones, including the release of the results from our large studies in colorectal cancer in collaboration with the Hvidovre Hospital, which we discussed earlier. We expect to release 4800 patient with retrospective colorectal trial data in the third quarter of this year, utilizing our Tecan robots, using the same assays, we used on the smaller samples priced manually to give us as good initial -- which gave us good initial results. It is important to note that we are now producing our own antibodies analyzing these samples by our Tecan machines. We expect to achieve detection rights and false positive rights at least as good under the previous [indiscernible] method but that will be determined by the trials ongoing. Importantly, we continue to optimize our panel, improve quality controls and now have streamlined analysis process utilized to maximize accuracy. We also expect to release the first results from 2,500 of our 14,000 prospective patient screening study that have now been collected. Having data from the prospective screening population will be another key milestone achieved for Volition. As a reminder, we released initial results in September of last year, which included 938 patient sample set as they represented subset of 4800 patients, which we’re completing now on Tecan machine. In addition to the detection rate of 84% in cancers, we detected early and late-stage cancer as well as each other as well as 60% of polyps as I discussed before. These results alone we believe would be sufficient for us to not only apply for CE Mark but also begin commercialization in Europe if prepared on a larger sample set, the sample set we’re completing now. The 14,000 patient perspective study that we are currently running is being undertaken as it is large enough to convince insurers to reimburse for nucleic acids test in Europe, once we begin commercial sales based on our early results. We forgot that the FDA approval of our nucleic test for colorectal cancer in United States, we expect to engage in a dialog with the FDA this year in order to determine what additional trials that will be required by the FDA to complete in order to get their approval. We expect to announce a framework plan and strategy including potential partners for commercializing and commencing the FDA trials in the U.S. by the end of this year or maybe next. We’re also very actively exploring the possibility of partnering with one or more CLIA labs in United States, whereby NuQ colorectal test could be evaluated in U.S. prior to FDA approval via CLIA lab waiver. This strategy if successful would allows us to commence some sales of NuQ testing in United States, generating initial revenue from VolitionRx and achieving some early market penetration in acceptance while we simultaneously pursue an FDA approval route for our test. With regards to our clinical trials in other cancers, we are pleased to be working very closely with Dr. Stefan Holdenrieder who has published extensively in the field of nucleosomes and he is running two of our clinical trials at the University of Hospital Bonn, in Germany. Our studies include 600-patient with retrospective trial in lung cancer within, which follows on from a very promising pilot study data released late last year in lung cancer. And recently, we announced the upgrade of the 4,200-subject patient study in the 27 most prevalent cancers. We should also have an issued data from our endometriosis study with Oxford University and our prostate study with M.D. Anderson in the coming quarters. Furthermore, we expect to announce one single month large clinical trials in pancreatic cancer following the stellar results of our 60 patient study which we released in January, which was released in January which I discussed earlier. We have also believed our Nucleosomics technology platform has very good potential and we are very pleased to be working with some of the leading research institutions in the world on a variety of clinical trials, including Oxford University here in United Kingdom, the University of Bonn in Germany, Lund University in Sweden, and M.D. Anderson Cancer Center in Texas to name a few. We continue to believe that largely the best platform through which the screen for cancer because it is convenient and has a higher compliance versus either complicated unpleasant or invasive test which often require separate doctor visits and to advance therapy work such as the colonoscopy, X-ray or biopsy. Blood test also tend to be quick and hours were required just a fraction of a drop of blood, which would allow our nuclear test to be administered during regularly scheduled schedule blood drop and tested on commonly used ELISA platform. Our blood test for variety of cancers are proving to be accurate, cost effective, convenient and rapid with the ability to detect early-stage cancers, which are still operable thereby quietly improving patient outcomes. We extremely started about recent current status clinically, commercially and financially and look forward to delivering on these numerous milestones throughout the remainder of 2015 and 2016. We also have a very active upcoming investor relations and market awareness calendar. We are presenting at the Marcum Conference in New York at the end of May and the LD Micro Conference in Los Angeles in early June and also have a non-deal road show planned -- road shows planned throughout May and June in New York, Boston, Philadelphia, San Diego and Los Angeles and San Francisco, as well as several other European countries as we continue to build investor awareness of Volition in United States and Europe. We are also hosting two webinars in May and June. One investor focused and other scientifically focused. Lastly, I’d also like to note that we plan to consistently host quarterly earnings conference calls going forward, so that we now regularly update our shareholders and analysts on the progress and answer any questions you may have. Thank you all very much for your interest in Volition and for joining our first earnings conference call today. And I’d be very happy to take any questions from you about any of this or anything else you may have questions on. Leila?

[Operator Instructions] We will take our first question from Brian Marckx with Zacks Investment Research.

Hey. Good morning, Cameron and congratulations on all the progress and all stages that you have ongoing.

Thank you very much.

The Q3 announcement that you expect, just for clarity, is that -- you expect all the 4,800 tranche of data to be included in that from the retrospective study?

Yes. The first Tecan, we have commission now for two months has been doing in roughly an assay per month through the entire sample set. So if it continues at that pace, we will have the whole -- everyone we did on the 938 finished in the July, August timeframe. So, Q3 is July, August and September. So sometime probably at the end of the quarter, we will be able to release the data on all the assays, which we did on the 938s but in the 4,800. So, yeah, so it is we are not doing all that assays and a little bit more, we are doing assay by assay because the roboticize machines works slightly better when you distinct single assay through a large number. So it’s slightly quicker. So the Tecan -- the first one is fully operational, administering one assay per month and we aim to have all that done but for the end of the quarter and announce it before the end of the quarter.

Okay. And in terms of CE mark filing and support for that, would that include the full dataset then? I think you had initially expected that it might just be about the first 1,000 patients.

Yeah. Very good question, Brian. You actually need a lot smaller number than we are doing to get a CE mark. So we are doing confirmatory trials at the University of Bonn for Holdenrieder is a pre-clinical setting in hospital. So it’s ideal for that. It will be smaller number of patients. The actual number we need is about 450. So, he will be doing confirmatory trials in his laboratory on those numbers. We have in place the things, which we needed to be in place included a manufacturer that will seek an FDA compliance which we now have. We’ve contracted in those, the first batch of kit compliant with CE mark being manufactured as we speak. The second thing was to have a quality system throughout out laboratory and in Belgium that is now completed and operational. The final stage is the final antibodies, which are now being produced. So once upon, the antibodies have produced the final commercial months, we will ship kits to Dr. Holdenrieder and he will perform on his 450 patients. The only step we haven’t finished is that final step of the confirmatory numbers. But that’s not to say, obviously 450 patients gets the CE mark. It doesn’t mean people rush out in pilot tests because people like to see very large trials. So that’s why we are doing all 18,800 patients in the Hvidovre hospital trials in Denmark. So, we have very large numbers for reinvestment. But it’s a little different as you may probably now but in Europe, it’s a two stage process. Getting the CE mark allows you to sell them and having very large trials really helps you with reinvestment so. But we are getting quite advance from the CE marks and as you can see from the trials, they are really progressing very smoothly now, so both of those are progressing very, very well.

Okay. Great. In terms of the precancerous polyp study, how well rapidly do you think that that moves along and when do you think you might have data and do you think that that data maybe available to support the initial commercialization I guess in Europe?

Yeah. Absolutely. We are trying a very wide range of assays. It’s not just for adenoma. There is also a 100 early stage cancers, so it’s a bit of both. It’s predominantly focused on adenoma but we think we may get some new markets in early stage as well although that’s very early stage already. It doesn’t take very long but that will also be done in the Tecan machines. The second one in the [indiscernible] will be up and running next month. So, we will be doing the 4,800, the two and a half thousand prospective and the adenoma study. So, I’d be very surprised if we didn’t have a large metadata by Q1, so certainly ready for commercialization. We are planning to do 30 assays for ovarian but it only takes a couple of days. Once you have the antibodies and have prepared them, it’s only a couple of days to do 800. So it can be sort of fit in between all the other things they are doing. But we are now prioritizing number one, the 4,800. Number two, the two and a half thousand prospective to get out in Q3 and Q4 perhaps with a prospective two and a half thousand. So, I’ll probably look more to Q1 for the 800 adenoma study that is certainly in process.

Okay. One last one on modeling OpEx. What should we think in terms of R&D and SG&A through the remainder of 2015? Do you think it looks like similar to what we are -- what you had in Q1?

Yeah. We are going through. I’m just actually in the process of now of re-optimizing all of that because it is a little lumpy in the last, this quarter and the next one. We’ve obviously bought three Tecans, although that relates to still upfront payments and it’s not a hell of lot of money but it makes, save us a lot of time. So it’s extremely worth it. But it’s a little lumpy this quarter and next, but I broadly think we are going to meet our targets as capital plan goes. I will get a very good idea of that by the end of next quarter to see how we are progressing. But as of March 31, we still had $11 million left. So we’ve got a lot to -- certainly an awful amount of money we’ve ever had, but we’re being extremely careful to keep very tight control on expenses and the any expenses we do in about speeding things up, so the trials happen quicker, so we can get revenue quicker. But currently I believe our expectations are very much along the lines of what they were before. We had spent some things up and none of that is very expensive, but there maybe some slight adjustments, but at the moment we are on target.

All right. Great. And thanks, Cameron.

Thank you very much for your time.

We will take our next question from Jan Wald with Benchmark Company.

Good morning, guys. And congratulations on the quarter. I guess I had a couple of questions. In terms of pancreatic cancer trial, what do you think your timeline for commercializing that?

Yes. That’s a very good question, something which I can’t give an exact answer for because there is a few different opinions. Look there is lot of things. Clearly everyone has a different opinion on what needed to get it. But I can say with some certainty, it would not need to be anywhere near the same size of trial as colorectal for couple of reasons. Ultimately we have to search with the best out there and at the moment see CA99 is the standard and it’s not 39. And it’s very difficult to get the very large patient studies that you could in colorectal because pancreatic is diagnosed say like -- currently it’s not easy to get 10,000 sort of cohort. So we are looking now -- as we discussed we are looking now as I discussed in the presentation for a larger trial. The next trial we are looking in the few hundred patients and I think we’re talking to other groups, the larger ones but we will not get into the 5000 or 10,000 certainly not cancer patient sizes. I think the next step is a few hundred cancer patients, hundred to a few hundred cancer patients to really show that it works very well. And that would be a sufficient for CE mark and it’s very similar to the numbers we are doing in colorectal now for the CE mark. We haven’t taken a view on what the FDA would like for that regarding just obviously got the results early this year. But the study we have in the process of attempting to line up, we think would get us to the CE Mark stage, but we have not yet taken a view on what the FDA would like to see because it hasn’t really been a world one.. The colorectal space has been a good one because it’s been a very well one half from a few different people. So it’s quite definitive what’s related much more so than in pancreatic. So I think the answer for us we have done a pilot study which was 60 patients. We are now in the process of getting one, which is three times the size, four times the size and we may have to get one in the 500 to 1000 range patient study was, but that’s what we are attempting to do now, then we will see what happens after that.

So if you were to put a crystal ball out there, would you think you will have CE mark sometime in 2016?

It’s hard to say. I don’t think we’re going to take as long as did in colorectal for couple of reasons. We now have a coronary system. We now have the design plate -- some new antibodies and some new ones but very similar process. So we don’t have to recreate a lot of the work we did. I wouldn’t want to put a guess on that optimistically perhaps by the end, but I would want to make any predictions. I do think it’s going to be -- if it continues, if we continue to get anywhere near the results we’ve got, I think we will get CE mark from the numbers we are looking at. But timing wise, I wouldn’t want to put an estimate at right now.

Okay. And I guess one last question, you mentioned optimizing the assays during the prepared remarks, could you talk a little bit about what that means, how you go bounded and what do you think you are going to get from it?

Yes. Absolutely. The early work we did we chose 938 patients as a repetitive sensitive sample from the 4800 for couple of reasons. It gave us specifically significant number of cancers, but also it was about the maximum we could do with the pipetting. So when we are optimizing, we are doing several things. Everything we do in the lab we are trying to do better. We know manufacture the plates externally from they used to be made on a table, a downstairs area. We now manufacture the -- in the process of manufacturing large batch of our antibodies, so it’s much more consistent, especially between different antibodies and different areas. We now have access to our capturing antibody which we will use in everything consistently. It’s about little things have been better at everything we do through experience, through bigger batches, through using much better external suppliers to do things. We are very lucky that almost everything we do is done by -- can be done by external sources, because it’s a very standard system. As we talked about what we do is very unique, but the methods are 30 years old. So a lot of things we can get other people to do better than we did initially, and then what we are hoping for is step changes of finding new assays. We’ve used about 8, 9 assays in colorectal now target structures of nucleosomes. There are literally hundreds of target structures that we are starting the process of now looking through to see which ones could also help with the firepower that we have already. So the assays we’ve used, but by no means charges by us to be the best possible. So I would just probably opportunistic do some research that could work. So we are looking for small incremental changes in everything we do, everyday in the lab and everyone we use for supply and everything. And also of course by the Tecan, our staff had amazing reproducibility manually, but the robot is a robot. So it is not perfect by any means, but it’s very good. And the company will use Tecan that was made, it’s slightly more expensive, so couple of hundred thousand dollars per robot, but the best ones we could find very, very good per system. So a combination of little things and hopefully big things, which will give us a bump in the actual accuracy and the leading which of the new assays is we had a nine and early cancer study that we have under the way from 800 patients. So we are doing 30 assays on those in the next few quarters as soon as we can to see if we could find other ones which can fit into the panel as well. But I think it was very important for us not to stop everything and stop the commercialization to get the perfect test because we believe where we are accuracy now is a very saleable product, especially in non-compliant people in U.S. and especially in Europe, whether frequent test -- we take frequent test is the main competition and throughout the world where we’re very, very competitive on cost in place into developing world where a few develops makes a big difference. So for all of the reasons, we’re doing a lot of work to make a better products, but we’re very serious to making sure that we actually launch product rather than spending on next three years just making a perfect product. I’m sorry.

So I guess I want to make sure I understand. From what you’re saying, you’ll probably be go to get a CE mark at a certain level specificity and sensitivity but work is going to continue. So you very likely will come out with better sensitivity specificity over time that you would move into the market.

Certainly I would like. But we believe that the product we have now is very saleable. We believe everything we do could well lead to some improvements. It’s possible that we fit in the best -- in the best way we could Taiwan but other thing that’s the case. We’ll find out, but we are doing a lot of work in the background. And so we’re also using the most basic formula lies, there’s a lot of multiplex in [Indiscernible] essence. So a whole lot of other ways have actually getting better detection. But we started to stick to a very simple platform early on to limit the number of variables. We didn’t want to be on dozen different platforms when -- the test hasn’t been fully shine. But yes, we are very comfortable with where we are now accuracy wise and we’re doing a tremendous amount in an attempt to push that up and we’ve only really just scratched the surface on what we feel is the potential with Nucleosomics.

Well, thank you, Kevin. And congratulations you made a lot of progress.

Thank you. Thank you for your support.

We’ll take our next question from Bruce Jackson with Lake Street Capital Markets.

Hi. Good morning.

Good morning.

Just a couple of questions on the clinical trial timeline. So with the prospective study at Hvidovre, are you still looking for some preliminary results around the end of 2015 or might those be on to early?

Yes, we are. Again, there is a lot going on the Tecan machines, so not guaranteed. But I certainly our arrangements to have the 2,500 done in the timeframe of this year and that I could stretch a little bit into next year in science. Some huge panel was going to straight line, but my current expectation was we should see data before the end of the -- in the prospective sample say.

Okay. And then I was still looking to start giving CE mark for some of the individual new cases starting in the Q3.

Yes. The only thing we’re waiting for is the final production antibodies and then due to the 400, it will only take Dr. Holdenrieder a small number of weeks to process 400 manually. So I would save the antibodies, but I think that’s our current estimation would be in the sense of the timeframe and then the 4,800 data.

Okay. And then when you have the results…

So I just to be make clear, once we have one, two, I think so just to answer question, but probably I didn’t quite answered.

That’s okay.

The first assay is usually is going to be the most work, which is what we’ve done with what we’re getting close to now. Once we have the first assay CE mark, we would see the other ones coming a lot quicker and maybe behind because it’s once you have the prices of the CE marks, it’s the only thing different with H1 is a new antibody and then redoing 400 assays manually, which takes a small number wise. So, as soon as we have the antibodies, our own developed antibodies that we could CE mark tomorrow both antibodies, but we thoughts it’s best way for our own in-house antibodies, which we can mass produce and do it much cheaper. So we’re waiting for those antibodies as soon as we have them. we will do the first assay and then we’d expect them to become reasonably fast behind them with a view to getting the final panel CE marks in the first half of next year. Its probably be in the end of the first half, so that we can launch a product in Europe. Now again, that doesn’t mean -- million people will run out next time to buy the product, but I mean, we can start the reimbursement work. We can actually sell up the product clinics and those other things. So it’s moving ahead very well.

Okay. Great. And then last question. Looking at the prospective trial for the anonymised in the early cancers, is that going to be part of the -- second, we probably the discussion you have with the FDA, want to go talk to them in terms of what it is…

Yeah. I think, yeah, that -- we would certainly hope, our assay is currently as you aware do very well early and very well with Polyps. But the Polyps would kind of that our assays would not target that Polyps, so we try on the couple of synergies we got the 60% was dependent on a small number of assays, who is coupled which did the hostile, where in the cancer it was a lot more to get us that a bit higher. So we’re looking to see if we can add to that hostile, which we’re hopeful, but until the trial is done no one knows the answer. But we would hope that that there will be new antibodies we could add to the panel and we would think if we can get anyway near over where we are now that will be very compelling for any regulatory authority to able to pickup early stage Polyps. And the 4,800 data should provide a lot of information on Polyps with the existing assays, not the new ones are looking from this study but from existing ones. So a lot of people, obviously, want information on how do we detect larger, more high risk Polyps, so whether multiple Polyps or more high risk Polyps and we have the data much -- in a much bigger degree in 4,800 limited 930 patients obviously. So we would see a key part pod of the data coming out, in the last quarter would be an analysis of the adenoma in the 4,800 study. And then when we’ve done enough of the 800 person just adenoma study, perhaps adding to that population as well. So there will be a lot of information coming out of that adenoma at the end of Q3, Q4 and early next year as we add all these pieces together. And also the prospective study will also include lot of adenoma, so all of these together would be some very good picture as to, we have good detection rights, but clinically you really want to separate out the different groups and we’ll certainly have enough information to give us very good information on the different sub groups, because when you had small number, when we had 938, which still a lot, but it’s a small number, it’s very hard to make small subgroups out of that, but there is certainly would be enough in this 4100 to make some judgments on the assays, which we’ve currently been using added to the ones from the 800, it should be a very large amount of information.

Okay. That's great. Congratulations on all the progress.

Thank you very much.

[Operator instructions] We’ll take our next from [Jack Lasde] [ph] with Morgan Stanley.

Good morning, Cameron. I want to clarify something with regard to the CE Mark.

Yeah.

Once approved, do you -- you previously announced that you got a market in Europe two national house systems and I believe that in that I’d like you to confirm that you’d said that that’ll be Q3 and then you had also said that subsequently in 2016 you may begin then to market two hospitals, labs, large doctor groups, et cetera? Is that -- are those statements correct?

Yeah. Just to clarify, yeah, basically, yes. The system here is different than the U.S. as I am sure, everyone is aware. You can in the -- the FDA routes you have to pick a final panel, you have to get a very sets clinical trial finished, which is as much a reimbursement trial as it is regulatory trails. In Europe it’s stood off, the first is the CE Mark, basically says, they are producing in a correct manner and the trail you run just has to be accurate so far as the accuracy of the tests. So and that's what we have done assay-by-assay. So we’ve done, let’s talk about eight to nine assays in Colorectal now and so to CE Mark each one of those assays individually is our aim. Let say, starting again with the first one which we are in the process of doing now and followed by each one rapidly behind that with a review to, so we’ll have a first CE Mark this year, aiming for the end of this quarter, the third quarter, but that doesn’t make a panel, because our good results were panel of four assays or depending on between three and five assays. So we need all of those to be CE Marked before we launch a panel as a reimbursable product. But what are -- what CE Mark each one individually allows us to do is we can mix and match different panels in different areas because four different things, some are better for adenomas and some are better for cancers. We will pick a panel which we’ll launch in Europe as soon as we have enough, but it does give us flexibility or to add a new one which we find from, for example, from the adenoma study on to the panel where we don’t have that option in U.S. The U.S. FDA are very strict about picking something finding fine and running with it. So that's why we’ve pushed the FDA to after the CE Mark process has started. So once we are certain about the final panel. So just to clarify, we will -- we begin CE Marking now and we enter the first one end of Q3, early Q4, probably this Q3. And then fast behind them, the ones to make to panel, then shaking up in the first half of the next year, probably near a midyear now. And then that allows us to commercially sell our kits in Europe. But as you correctly point out, that doesn’t mean the healthcare system will buy it on the small numbers needed for a CE trial. That's why we are doing these very large trials as well. So, we aim to have the 4,800 finished by the end of Q3, which we’ll announce. So that's a huge study for the European governments. But we also thought it was important to do a prospective one as well. So that's why we are doing this 14,000 patient study as well. So, we have two and a half thousand of that 14,000 in our freezer now from the prospective. And our Danish partners are collecting in the region of 500 per month. So it will be chunks every quarter. For every three or four months, we’ll get another few thousand samples we can d. So it will pretty quickly become a very sizable study. So the combination of all of those will get the CE marks while concurrently doing these large trials to encourage reimbursement. Does that answer your question?

The reimbursements won’t begin until you have a panel, is that the idea?

Yeah. I don’t think -- we’ve sounded out some of the reimbursement people we are getting plans. We are in the process of engaging people in Europe and the United Kingdom to do the work for us. By they advised -- they said was, at least get the first few CE marks and have a timetable, a final timetable before the end of the rest, before you very strongly engaged the actual regulatory organizations. So, we are in the process now of doing all the background work so we can hit the ground running.

And that's when you left the hospitals and the labs and doctor groups?

Correct. Yeah, the European markets are a little different than U.S. It’s about depending on the country but it’s certainly in single digits private payers, so they are big, big people. I mean, the private payers are a good early resource of revenue. But ultimately, the main game has to be in the large countries because basically you have 28 clients plus a small -- these small ones but 28 big clients. So, we don’t see us else being able to target all of them at the same time. Obviously, we are not a big company. So the plan has been doing hit list of a couple of countries to start with, one being a couple of small countries. There are few contenders we are working for now to see which ones are the best ones to start with. It’s not a merely obvious which ones to start out with. Sometimes, some counties have screening programs, some don’t. You might think it’s easier to start one with a program but they are often funded for two or three years so you could await for the end of that but there’s a lot of choices in Europe to start because there are 28 countries. So, we are just working now and a lot of them have no screening programs at all, so you start a program. So, we are doing analysis now of which countries to start and then wrapping up county-by-country because it is way beyond doubt that we will reach to launch in 28 countries concurrently. So, we will start with one large and the couple of small countries as test markets and then rollout beyond that. That's the aim.

All right. Great. Because my second question is the medical and largely the investment communities generally are sceptical until you publish in medical journals where things are peer-reviewed. When can we expect to see that kind of a scenario start to play out?

Yeah, absolutely and we are very serious. I guess my -- I was involved in a company very early on where we published -- he didn’t have a commercial product nor our focus or all other efforts on getting a commercial product. But I think you are absolutely correct. We are in the need of publishing of renewing the process now. There is some things underway. It’s not republic, so you’ll expect to see some publication from us in the not too distant future in the range of different cancers. What we’ve now -- we are fully comfortable with our IP. We are fully comfortable with our commercialization. The team is now focusing a lot more on getting some publications. So that’s certainly something which now is a priority and we expect to see that in the not too distant future.

All right. Great. Thanks and congratulations and best of luck for a continued success.

Thanks for your time.

[Operator Instructions] We will take our next from Menachem Kranz with Ahava Investment Partners.

Hi. Good morning, Cameron.

Good morning, Menachem. How are you?

I’m all right. Thanks. Just a couple questions. Talk about if you can, the study, the extended study now in Germany instead of what are you trying to get out of that study? How big can it be I guess and then really what’s the downside to that, meaning if it doesn’t work, how does that hurt us? So take us both ways with that and then which way do you want to run with that?

Yeah. Thank you. It’s very important so far. I think really on we naively thought we would have a test for “cancer” meaning cancers. But ultimately clinically is bit of a disaster because it scared someone when you can tell them they’ve got cancer because you don’t know where it is. So we focused early on, on the colorectal, because it was very good cancer to guess out of it and something where the goal standard although expensive and invasive and well compliant is very accurate. So our clinical trials, we manage due incredibly, cost effectively and quickly at a lightning speed compared to most therapeutics or even diagnostics. But single cancers are incredibly valuable. You see Exact Sciences, multi-billion dollar-companies based on a fecal test in a single character. But ultimately a new Nucleosomics Technology is not a single cancer mark, the changes we look for, been shown to be in every cancer and raised level of nucleosomes and the Dr. Holdenrieder, the work he done in a very wide range of cancers. So we always though, it could and should and would be expandable, but we were very focused on getting one product out to the door to make sure we had good revenue. And as you can see a company can become a multi-billion dollar company purely on one cancer. But Dr. Holdenrieder trial, I’m extremely excited about, no company booked to read anyone is doing it but -- and have -- all we got David, no one has ever looked in the same study at the range of different cancers using the same assays. For me personally, I’m really, really energized by this trial because not only is it a pilot study in 27 cancers and that’s every single cancer that really is, is ever really going to be worked on. It drives into very high 90% of cancer by incidence. So what our dream would be and this is certainly not -- we have indication from the trial is to find a set of assay which control the cancer from each hour with the aim of telling -- diagnosing multiple cancer with the same blood group. Now we won’t have those results until the trial is finished. It’s speculation until that’s happened, but that’s the purpose of the trial is to see if we can find assays which could distinguish between the cancers, and therefore you could have a single test from a multiple cancer. Now as far as humanity in the company goes that would be beyond value, but it’s all speculation until we do the trial. But I think the trial is as good as it could be. Dr. Holdenrieder is, in my opinion the worldwide expert, if anyone in the planet in nucleosomes. He has collected 27 cancers from his hospital and are very well matched other conditions, other diseases, and so he shared it with each of those single cancers as well as healthy. So it’s a good trial, we could get. We now make a very wide range of different assays, which we will be sending to him. So it’s blended to us. He is getting our assays, our plates and running the trial himself. And he collected the blood, so it’s completely independent. So we would know by the end of this trial how our assays, once we developed anyway so far and there is a lot more to go, work in the 27 most prevalent cancers. And we know if single blood test could tell between cancers. And to me it’s incredibly exciting and we expect the first lot of data in the first half of next year. I’m extremely excited to say how that goes because it would be incredibly useful if that was the case.

Thank you.

That answered your question? Thank you.

Yeah. No. That’ all I have lot more I heard. Thanks.

Thank you.

And there are no further questions at this time. I’d like to turn back to our speakers for any additional or closing remarks.

Thank you everyone.

Thank you everyone.

Thank you for coming on the line everyone. We are very, very much appreciate your interest in Volition, and our team own are very much hunted down implementing business plan which is to use the very large capacity that we’ve now. To finish all this a very large trials which we’ve lined up and to commercialize as soon as we possibly can to really drive shareholder value. And thank you for all your faith in us. We would shortly work as far as possibly we can over the next quarter to implement the plan that we put forward to make nucleosomes a real, important part of health diagnostics. Thanks you. Scott, do you have anything else to say?

No. Just wanted to thank everyone for joining us today for our first Volition earnings conference call. And we appreciate your interest in the company and look forward to speaking with everyone in the near future.

That concludes today’s conference. Thank you for your participation.