Earnings Labs

VolitionRx Limited (VNRX)

Q3 2018 Earnings Call· Sun, Nov 11, 2018

$2.72

-0.33%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.
Transcript

Operator

Operator

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.

Scott Powell

Analyst

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?

Cameron Reynolds

Analyst

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…

Operator

Operator

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

Jason McCarthy

Analyst

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.

Cameron Reynolds

Analyst

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…

Jason McCarthy

Analyst

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?

Cameron Reynolds

Analyst

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

Jason McCarthy

Analyst

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

Cameron Reynolds

Analyst

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.

Operator

Operator

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

Unidentified Analyst

Analyst · 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.

Cameron Reynolds

Analyst · Oppenheimer. Please go ahead.

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.

Unidentified Analyst

Analyst · Oppenheimer. Please go ahead.

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?

Cameron Reynolds

Analyst · Oppenheimer. Please go ahead.

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…

Operator

Operator

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

Jonas Peciulis

Analyst · 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].

Cameron Reynolds

Analyst · Edison Investment Research. Please go ahead.

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.

Jonas Peciulis

Analyst · Edison Investment Research. Please go ahead.

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?

Cameron Reynolds

Analyst · Edison Investment Research. Please go ahead.

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.

Operator

Operator

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

Bruce Jackson

Analyst · 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.

Cameron Reynolds

Analyst · The Benchmark Company. Please go ahead.

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…

Bruce Jackson

Analyst · The Benchmark Company. Please go ahead.

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?

Cameron Reynolds

Analyst · The Benchmark Company. Please go ahead.

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

Operator

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

Brian Marckx

Analyst · 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?

Cameron Reynolds

Analyst · Zacks Investment Research. Please go ahead.

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?

Brian Marckx

Analyst · Zacks Investment Research. Please go ahead.

Yes.

Cameron Reynolds

Analyst · Zacks Investment Research. Please go ahead.

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.

Brian Marckx

Analyst · Zacks Investment Research. Please go ahead.

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

Cameron Reynolds

Analyst · Zacks Investment Research. Please go ahead.

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.

Operator

Operator

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

Jay Albany

Analyst · 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?

Cameron Reynolds

Analyst · SeeThruEquity Research. Please go ahead.

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.

Jay Albany

Analyst · SeeThruEquity Research. Please go ahead.

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?

Cameron Reynolds

Analyst · SeeThruEquity Research. Please go ahead.

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.

Operator

Operator

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

Cameron Reynolds

Analyst

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.

Operator

Operator

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