VolitionRX Ltd (VNRX) 2021 Q2 法說會逐字稿

Hello and welcome to VolitionRx Limited Second Quarter 2021 Financial Results and Business Update Conference Call and Webcast.

(Operator Instructions)

As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Scott Powell, Executive Vice President, Investor Relations. Please go ahead.

Thank you and welcome everyone to today's earnings conference call for VolitionRx Limited. This call will cover Volition's financial and operating results for the second quarter of 2021, along with a discussion of our recent activities and key upcoming milestones.

Following our prepared remarks, we will open the conference call to a question-and-answer-session. Also, on our call today are Mr. Cameron Reynolds, President and Chief Executive Officer; Mr. Terig Hughes, our Chief Financial Officer; and Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC.

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, quarterly reports on Form 10-Q, 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 would now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thank you everyone for joining Volition's conference call today. I would especially appreciate it, given how busy you all are during the earnings call season.

And speaking of busy, our whole team has worked very hard during the pandemic towards our goal of becoming a commercial enterprise. As you might remember from our last call, we have had quite a start to the year and made excellent progress in developing a range of products based on our proprietary Nu. Q platform, in addition to making significant progress in negotiations over a number of potential licensing arrangements. I expect that we will have a lot of news throughout the remainder of this year on progress with our numerous commercialization efforts.

I will be updating you today on our patents, publications, products, people, and most importantly, progress within our 4 key pillars: Nu. Q, Nu. Q Vet, Nu. Q NETs and Nu. Q Capture. And I am delighted that Dr. Tom Butera, Chief Executive Officer of our Veterinary subsidiary, is joining us to update on the fantastic progress and upcoming plans on Nu. Q Vet.

To start off, however, I'll quickly hand over to Terig for the financial report.

Thanks, Cameron, and thank you everyone for joining our earnings call today. I will now provide a summary of the key financial results for the quarter ended June 30, 2021.

During the second quarter of 2021, we reported a net loss of $5.6 million, compared to a net loss of $5 million in the same period last year. This result reflected research and development expenditure of $3.6 million, up slightly, compared to approximately $3.5 million in the prior-year period; general and administrative expenses of $1.8 million, approximately $300,000 higher than the prior-year period; and sales and marketing expenditures, which more than doubled to $459,000, primarily driven by our ongoing transition to a commercial organization.

Grant income earned in the quarter was approximately $400,000, $300,000 higher than the same period last year.

During the second quarter of 2021, we also received approximately $857,000 of net proceeds through our at-the-market, or ATM, equity distribution program. And so, we closed out the second quarter of 2021 with cash and cash equivalents of approximately $27.9 million, compared with approximately $19.4 million at the end of 2020. We expect the cash burn rate going forward to average around $2 million a month, excluding the impact of income from a licensing deal or deals, if any. And so, the company continues to be in a strong cash position, providing us significant runway towards achieving our commercial milestones.

From a revenue perspective, we recorded $25,000 in product revenues for the second quarter of 2021, mainly from the beta launch of Nu. Q Vet. This was steady with the first quarter of 2021 as expected, given the nature of the beta launch. I don't want to steal Tom's [standard], but given the interest we are seeing in the Nu. Q Vet product from a licensing perspective, we anticipate significant future Vet revenue opportunities to come from licensing arrangements including potential upfront payments and commercial milestones, rather than just directly booked sales.

Last but not least, our new commercial team continues building a solid pipeline of sales opportunities with interest developing for Nu. Q Discover, our sample processing service for external parties such as pharmaceutical companies, biotech companies and academic researchers. We believe that this opportunity should also translate into some solid revenue this year.

And with that, I will pass back to Cameron for further operational and product updates.

Thanks, Terig. I am delighted to have such a strong cash position, with still a consistently low-burn rate providing us significant runway towards achieving our commercial milestones, and so to patents, our core element of our competitive advantage.

We have a broad intellectual property portfolio, which covers both human and animal applications, and we continue to strengthen our protection, or widen our moat, so to speak. Our research and development team is both highly innovative and prolific, and we work hard to ensure their inventions are protected to the fullest extent of the laws, so that we might gain commercial advantage.

The first half of 2021 was extremely busy from a patent filing point of view. And so, I expect our patent portfolio to continue to grow in the quarters and years ahead. As of June 30, 2021, our portfolio includes 27 patents families, plus 3 in-licensed families, 10 granted patents in the U.S., 14 in Europe, and a further 47 patents granted worldwide. We also have 89 patents pending.

Our next key, publications.

Given our comfort with both our IP position and the stability and robustness of our Nu.Q platform, publications and abstracts remain one of our key objectives; and our list of publications and abstracts continues to grow.

Starting with our veterinary team, our second clinical paper was published in respect to BMC Veterinary Research at the end of the quarter, with a third clinical paper accepted and due for imminent publication now. A fourth paper will be submitted later this month, detailing new clinical data for our Nu. Q Vet cancer screening test, broadening its application to 7 of the most common canine cancers.

Also, on the veterinary side, we have had 2 abstracts accepted for the Veterinary Cancer Society Meeting, due to be held in October. We will showcase a lot of new data, firstly, using our Nu. Q assays to monitor both disease progression and treatment response in dogs with cancer, and secondly, our first-ever data using our patented Nu. Q Capture technology in dogs with lymphoma.

An absolutely fantastic effort on the R&D side from the veterinary team and the researchers at Texas A&M University. Well done to all.

Also published this quarter, in Nature's Scientific Reports, was a fundamental research project, led by Professor Stefan Holdenrieder with some Volition team members as co-authors. The paper was entitled - serial profiling of cell-free DNA and nucleosome histone modifications in cell cultures, summarizing a better understanding of the cell-free DNA and cell-free DNA biology by measurements [and pairing] in 3 different cell lines: total cell-free DNA, fragment sizes and epigenetic profiles of nucleosomes, in the aim to develop comprehensive clinical assay.

I am delighted that our team is involved in such cutting-edge research and that our efforts are leading to published papers. More recently, data has been presented at an International Congress by 2 collaborators from leading U.K. hospitals using the Nu. Q NETs assay in COVID-19 studies. These posters included early-stage data showing that results, with a Nu. Q NETs test on admission could predict future COVID-19 disease severity and that zero results correlate with disease progression. A fantastic result and great for the data to be reported at such an internationally-renowned congress and to be working with such great colleagues.

We are pleased to be making progress in our rigorous approach to present data where we can, in either peer-reviewed papers or at conferences. However, it does mean a lag time for study results for publication. By the way of example, the data from these 2 studies was finalized in February, March, however released only at the end of July.

All in all, 2021 has been our strongest ever year to date with publications and we expect more papers, posters and abstracts in the second half of this year.

And so, to our product updates. First, our Nu. Q NETs.

As a reminder, we believe our Nu.Q NETs assay will have wide applicability for monitoring diseases with a NETs component, such as COVID-19, influenza, sepsis, autoimmune diseases and cancer, quite a list; and potentially to risk stratify patients for treatment selection.

We had previously reported preliminary results, demonstrating that our Nu. Q NETs assay correlated well with current COVID-19 disease severity. The recently published posters show that early-stage data with the same assay demonstrated that results on admission could predict future COVID-19 disease severity and that zero results correlate with disease progression.

The lead author of the first poster, Dr. Catherine Rea, said the Nu. Q NETs biomarker results taken on hospital admission in this study correlated with COVID-19 disease severity and were predictive of whether patients required care in a general ward or organ support in an intensive care award. The study results also indicated that elevated values of Nu. Q H3.1 could predict poor outcomes in patients admitted to Intensive Care, including an association with 28-day mortality and may be of value in risk stratifying patients for treatments such as therapeutic anticoagulation as well as in monitoring patient response to treatment.

Dr. Sophia Stanford, Lead Scientist and Author of the second study, commented, whilst this was a small exploratory study, the Nu. Q NETs H3.1 biomarker values closely tracked the clinical course of COVID-19 patients admitted directly to Intensive Care, admitted to a general ward or admitted to a general ward and then transferred to Intensive Care during the hospital stay. These findings suggest that the Nu. Q H3.1 assay may be able to risk stratify COVID-19 patients on admission and monitor disease progression in individual patients.

Strong findings from these studies and I'm delighted to say we have further large studies in progress in COVID-19, sepsis, and other diseases, due to be completed soon, with the publication of further data expected in the coming months.

During the second quarter, we hosted our first Key Opinion Leader workshop on NETosis and are delighted with the level of openness and collaboration across the team. We have our next session in the coming weeks and look forward to continuing this positive dialog.

Lastly, with regards to NETosis, a people update.

I'm delighted to say that we have a seasoned product manager joining us in August with a strong track record working in sales and marketing for Roche Diagnostics for over 20 years. A fantastic addition to the team. I'm sure it's something we're aiming to help us develop the first products.

To summarize, where we are in what I think is an extremely exciting new area for our proprietary Nu.Q platform.

We have excellent results to date with a range of different world-class collaborators, with more results to come, and we are now looking to transform these results into a range of net products worldwide. Given the numerous potential commercial uses that we have identified to date and our expectation for further identified uses, we have also expanded the team to include a very experienced industry professional to help us with this process. We aim to launch our first commercial CE Marked next product in 2022 and to outline the strategy for an FDA approval of next product this year.

And that leads me to another fantastic addition to our team as I hand over to Dr. Tom Butera, Chief Executive Officer of our Veterinary subsidiary. You may remember Tom originally joined the Volition team as an Independent Director on our Board. But we were then delighted when he agreed to come on board full time as CEO of the Vet business. Tom, a seasoned veterinary executive with a fantastic track record, joined us directly from the Veterinary Centers of America, VCA, part of the mass veterinary group, where he served as Business Development Director. We are thrilled to have someone of Tom's caliber and experience join us. Whilst he only joined us at the beginning of May, he has truly hit the ground running and has some fantastic updates to share.

Tom, over to you.

Thanks very much, Cameron, and thanks to everyone who has joined the call today. Wow, a busy first 3 months in my new role, but tremendously enjoyable and rewarding.

I'd like to start off by complimenting the Volition team and the researchers at Texas A&M University, led by the incredible Dr. Heather Wilson-Robles, on the great work they have done in developing a simple, easy-to-use blood test to address a huge unmet need in the veterinary market. It has certainly made my job much easier.

Cancer screening is not yet as commonplace in animal health as it is in human health, but I believe blood tests like the Nu. Q Vet cancer screening test could significantly help transform how veterinarians manage cancer in companion animals. Early diagnosis of cancer has the potential to help improve the treatment and quality of life as well as providing valuable, additional information to inform the clinical decision-making process. I've had the opportunity in these first few months to really dig deeper into our ongoing research. I'm extremely excited about the clinical work being done by a veterinary team to date. There are numerous clinically-relevant concepts we have for future programs and I believe that we were really -- are only at the very beginning with the Nu. Q platform in the veterinary world.

So, where are we today?

The recent clinical paper published on the 29th of June, authored by Dr. Wilson-Robles, reported that the Nu. Q Vet cancer screening test detected almost 82% of hemangiosarcoma cases at a very high specificity of 97%. The test detects all stages of the disease with unsurprisingly nucleosome concentration levels increasing with disease severity. A second paper, co-authored by Dr. Wilson-Robles, has been accepted, and as Cameron mentioned earlier, is expected to be published any day now. This paper shows the data for Nu. Q Vet in detecting a very high proportion of lymphoma patients, again, at the same specificity.

The clinical team has also completed the analysis of over 600 canine subjects, 504 cancer patients, and 134 healthy controlled dogs. Unfortunately, I cannot say too much on the call today as this data will be submitted for publication at a widely-read peer-reviewed veterinary journal. But I am happy to say that nucleosome levels were evaluated in plasma samples from patients with 7 of the most common canine cancers, so we do expect to broaden our marketing claims in the coming months. So please watch this space for further updates on this multi-cancer comment.

Dr. Wilson-Robles also presented new data as an invited speaker at the ACVIM forum in June. This is a closed meeting, so the proceedings are not reported. However, in an abstract regarding the use of Nu. Q Vet in monitoring disease progression and treatment response has been accepted by the Veterinary Cancer Society Conference in October. So we anticipate more clinical news there.

These studies, papers and conference publications, while time-consuming, are helping to build our profile and credibility with KOLs, oncology specialists and GP doctors, which I firmly believe will position us in a formidable leadership position, long term. There is also significant progress being made to help expand the clinical utility of the current Nu. Q Vet cancer screening test, in addition to fueling new product development for the monitoring tests.

We are continuing our work with several veterinary university teaching hospitals to collect samples from additional cancers as well as other non-cancerous conditions such as inflammatory conditions, benign splenic masses and endocrinopathies, et cetera, to determine how they may affect the plasma nucleosome compartment. This data may help us better differentiate between cancer and other diseases, and help provide further very relevant products in the future.

Clinically, I couldn't be happier with our Nu.Q Vet product, so let's go tell these folks about it.

This quarter, I had the pleasure of attending the 2021 VMX Conference in Orlando, Florida. While the physical meeting attendance was smaller than usual due to the pandemic, there was also a virtual format available and we had great interest on our Nu. Q screening test. We were delighted to be featured at Dr. Sue Ettinger's aka Dr. Sue Cancer Vet's presentation entitled - what's new in cancer 2021. Sue was just a great speaker and a great advocate for us, and we will be filming some of our Nu. Q case studies soon.

We have a busy program planned through late summer and the fall too. We will be presenting and hosting a booth at the upcoming Western Veterinary Conference in Las Vegas in September and then at the Vet Show in both New York and London. As I said earlier, we hope to have poster sessions at the Veterinary Cancer Society Conference in October. These conferences are helpful, not only in raising our profile, awareness and credibility, but also engage in important dialog with numerous veterinary colleagues. These invaluable conversations help us to truly understand some of the unmet needs to provide improved diagnostic cancer screening and monitoring tests for their pet owner base, which serves to fuel our future product development. While we are certainly confident in our current knowledge base, we are always listening and open to new ideas, which we are sure to get in our busy conference booths.

And so, to a more commercial update.

In terms of commercial opportunity in the addressable market, cancer in dogs is widespread. It is a leading cause of death with dogs over the age of 10 and there are over 6 million new dog cancer diagnoses in the U.S. alone each year. And as I said earlier, cancer screening is simply not commonplace currently in the animal health market, but the need is there; the potential to help veterinarians, pets and their owners is there.

The Nu. Q Vet cancer screening test is positioned for use during the annual preventive care wellness tests for older dogs, 7 years and older, and for dogs from 4 years and older of at-risk breeds, such as Golden Retrievers. Approximately 80% of dogs visit the veterinarian each year. And according to the AVMA, in 2016, there was 77 million dogs in the U.S. alone, a number which has grown significantly during the pandemic. So the addressable market is simply huge.

But, how are we accessing the opportunity?

Our beta launch has achieved everything we wanted from it and we have gained extremely valuable insight into all aspects of this great first Nu. Q product. Interesting, though, I think likely the most valuable contribution from the beta launch has been the high level of interest it has garnered from some of the world's biggest veterinary companies. This is not totally surprising, given we are the only company with the outstanding Nu. Q platform, and there are multiple large potential licensees, distributors, very interested in our veterinary products, which puts us in a solid negotiating position.

Clearly, I am new to the Volition team, but I believe it is no secret that Volition does not currently have the ambition to assemble its own large-scale sales and marketing teams, but rather to focus our skill set and know-how on scientific breakthroughs in intellectual property development and to drive the revenues by licensing our patented technologies to large companies, already placed within the relevant marketplace.

And so, a great deal of my time together with our Chief Commercial Officer, Gael Forterre, and other talented members of the Volition team, has been spent identifying, vetting, working with, and negotiating with several potential licensing partners around the world. We are not at the finish line just yet and I clearly cannot disclose too much, given the very active negotiations. But we have a lot of good folks around the table and are certainly at the business end of negotiation with a number of prospective partners. We hope, and I know all of the prospective licensors hope, that terms can be finalized in the coming months and we aim to have a very meaningful deal signed in 2021. On behalf of the whole team, I'll be delighted to share that news with you just as soon as we can.

In summary, a fantastic start to my time at the company. I have appreciated the warm welcome from my colleagues, but more importantly, have been incredibly impressed with the quality of the work completed to date and the exciting plans we share.

And with that, I'll hand it back over to Cameron.

Thanks a lot, Tom. Great to have you on board. We too appreciate all your hard work and the experience you bring to the team.

I'm conscious of time, so I'll briefly provide a quick update on a couple of other items.

I think it happened just as the March quarter closed, so as a reminder from our Nu. Q Capture perspective, we published a clinical paper in Nature's Scientific Reports, which details our novel proteomics approach to epigenetic profiling of circulating nucleosomes in the blood of cancer patients. We believe the Nu. Q Capture technology will be useful not only when used in combination with mass spectrometry to discover new biomarkers as per this paper, but also as the DNA enrichment technology which could aid diagnosis, treatment selection, and both treatment and disease monitoring, when used in combination with either sequencing and/or our Nu. Q assays. The Nature's Scientific Reports clinical paper was a great first paper on our Nu. Q Capture with further human studies expected to be submitted in the coming quarters.

And as I mentioned earlier on the call, we have submitted an abstract to the Veterinary Cancer Society Meeting using our Nu. Q Capture technology in dogs with lymphoma. It is exciting to see our third pillar of Nu. Q Capture branching out in terms of research from humans to vet users as well.

And so, to our oldest and fourth pillar, Nu.Q in human cancers.

Unfortunately, given the pandemic, some, but thankfully not all of our studies, have been affected due to a very difficult collection and enrollment environment. And we have pivoted to those areas, where we can still make progress during lockdowns. The brightest note in this pillar during the pandemic is in Asia, where I'm delighted to announce we have reached our target patients cohorts for both colorectal cancer studies and lung cancer study, all collected in conjunction with the National Taiwan University. A fantastic effort by the team there.

We're excited to have just completed preliminary analysis of the lung cancer study and look forward to reviewing with Professor Chen and his team ahead of publication, either through clinical paper or conference abstract. We're also running the assays and finalizing the analysis for the CRC study and anticipate these findings will be presented at a conference in 2022.

As previously reported, collection for the U.S. EDRN colorectal study has been paused. In what is hopefully a good sign, I'm happy to announce today that after 15th month pause, EDRN reinitiated enrollment in June and aims to be enrolling at full capacity in September. Given all this, the expected study completion date has been extended by EDRN to the fourth quarter of 2022.

Regarding our 2 U.S. blood cancer studies, these timings too have now been impacted by the pandemic, due to collection and protocol issues. For the 1,500 subject NHL diagnostic study, all preliminary protocol development and study preparation has been completed. Given the experience we've had with EDRN, we're closely monitoring the ability of clinical sites to perform the study as COVID restrictions dissipate, while ensuring our pre-analytical and logistical procedures align with routine clinical workflow.

We now aim to begin collection late this year, protocols and pandemic permitting, and submit the first data to the FDA late in 2022. COVID restrictions have also made sequential therapy-matched specimen collections exceptionally difficult in the DLBCL Treatment Monitoring Study. We now aim to issue interim analysis results later this year.

We also have ongoing negotiations with a major player in Asia on our first human cancer launch in China. We will, of course, keep the market updated on any successful transaction being closed. As discussed on previous calls, following the opening of Silver One, we have installed a service lab in the new facility, which will undertake sample processing for external parties, such as pharmaceutical companies, biotech companies and academic researchers. We have branded this service Nu. Q Discover and have already generated much interest. We have commercial interest from, and quotes sent to multiple pharma and biotech companies, and anticipate revenue from this activity this year and continuing to grow in the future.

Thus far, the projects we are handling through our Nu. Q Discover service involve exploring the use of our Nu. Q assays to monitor the efficacy of our customers' therapeutics in developments for cancer, NETosis, and other serious and chronic diseases in both pre-regulatory and regulatory trials. These projects, if initiated, and indeed if the outcome is positive, could lead to more significant revenues for Volition if our assays are proven as companion diagnostics to our customers' therapeutics.

And so, to the future.

I would like to reiterate our vision and what makes us so excited with the progress and our space. Volition is an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human and animal health. This has been our mission since our founding and is coming to fruition with our Nu. Q platform at the very heart of epigenetics. We believe the last decade of work at Volition with our ever-expanding team in epigenetics puts us in an extremely strong position with our expansive IP portfolio to be a significant player in this key field.

Overall, on so many fronts, with our ever-growing team and IP, I'm delighted with the progress we are making and I'm excited by the momentum we have developed in the epigenetics field. Indeed, our whole team is incredibly excited by the company's future opportunities. We aim to report, throughout 2021 and beyond, numerous key milestones, now that we are in full swing in turning our platform into a range of products worldwide.

We will focus on driving revenue in the coming quarters in the following key areas. One, licensing of our technology, [with a particular with an exclusive focus] on Nu. Q Vet with the aim of signing the first deal or deals this year. 2, Nu. Q Discover processing samples at Silver One using our Nu. Q Discovery assays. And 3, disease monitoring tests, such as COVID-19 and sepsis.

We also aim to publish data on multiple fronts across our 4 pillars. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming months and year with our optimized platform. Thanks for joining the call today. I very much appreciate it, given this earnings call season.

We're happy to take questions now. Operator?

(Operator Instructions)

Our first question today is coming from Bruce Jackson from Benchmark Company.

So if we could just talk a little bit about the Nu. Q Capture product line, the paper in Nature, of course, is a major milestone for you. Lots of potential applications here. Have you gotten any like inbound interests from people who want to work with you on this, either in their own labs or with Silver One?

Yes. Good question, Bruce. So the Nu. Q Capture program, we've been making progress, I guess, on the 2 fronts. So it's split into the sequencing and mass spectrometry. So as you -- I'm sure -- read the paper; the paper was on the mass spectrometry side. So we are starting to generate some interests on that side and it's been encouraging. The sequencing side, we hired -- I think you remember and you met Dr. Terry Kelly in California, she's been building a team to fully optimize that process as well. So it's too early on the mass spec side because it's like our assays, we've had to spend a lot of time making sure it's very robust and reproducible and very good enough to be a product.

On the mass spectrometry side, given the paper and the work we have, we are seeing interests. But the commercialization focus, given Capture is still very much a work in progress, has been less of an effort than in the Vets and the NETs and the human cancer side. Because, as with everything else, we want to make sure it's fully optimized and quite reproducible before we really start marketing aggressively. But there has been some interest on the mass spec side as incoming interest, but I wouldn't expect for us to put a lot of effort into the Capture side commercialization until it's fully optimized. So hopefully, sometime in the next 12 months. But I guess, we'll see how the optimization goes.

Okay. Great. And then moving over to the NETs, you outlined the FDA regulatory strategy really quickly. I was hoping you could just go through that again. I didn't quite catch if it was you're going to have the strategy by the end of this year or if it was going to be ready to submit by the end of the year? if you could just run through that one more time, I'd appreciate it.

Hopefully, yes. Not to submit by the end of the year, it's to get the strategy.

So I think on the Nu. Q NETs side, we've been very happy with the data and the fantastic collaborators we've had. And it all lines up incredibly well. Our team and our collaborators are exceptionally happy. Now we're in the process of working out, I think. To put it in one way, we're [sipping from a voyage of opportunities]. So we're following a little what we've done on the Vet side; we've strengthened the bench with an industry professional; he'll start soon. We've had great data with collaborators.

Our strategy will be a very similar one. In the sense, we'll launch our own product, but also look to use it in a wide range of areas with other industry players, other collaborators. So the outline, we're talking with several parties in the U.S. about potential uses of it in areas like sepsis. Jason has been doing a lot of work with CRO on working their own 510(k) study alone and we've also been talking to partners about using it in conjunction with other things that are currently used in COVID and sepsis. So the aim is to sort of get all that ready for the FDA work and outline our strategy this year. And on top of that, we're looking, of course, on a European strategy, which our new hire, who is ex-Roche for decades. He is helping us with this well.

Does that answer your question, Bruce?

It does.

(Operator Instructions)

Our next question is coming from Nathan Weinstein from Aegis Capital.

So perhaps, we could start with Nu.Q Vet and just would appreciate sort of a general view into the beta launch, how that's going, any reception, reorder rate, or anything you could say just to, kind of, help us understand how the Vet is proceeding would be great.

Yes, absolutely. Thanks, Nathan.

So I think as Tom very well put, it's done everything we wanted it to do. It was done to make sure, where all the aspects are ready for our own launch, which was the focus of the last call. Since then, as you probably gathered, our focus has been on partnerships on the launching with sort of very major players. Their interest has been very, very large, and strong interest from the large players. So Tom has been spending a lot of his time making sure that the negotiations are going as well as they can and as quickly as they can. So our strong focus now is to license through one of the big collaborators, as he said.

So the beta launch, I think, showed us a few things. I think the interest from the vets has been very high. I think we've worked out all the issues we had to do with shipping and packaging, all those kind of things, so that we certainly can launch ourselves. And I think the best way to make sure you get a good deal is to be able to do it yourself. Under no circumstances, will we sign a -- what's not a good deal with a vet company, because we can launch ourselves and we've shown that now.

But the interest has been very large, as I said, from the vet companies. And why wouldn't it be? As Tom said, it's a fantastic platform. It's a mass market easily. We think it's easily several million tests per year, which is potentially hundreds of millions of dollars in revenue. So even for the one of the big vet companies, that moves the needle. So yes. So it did everything we wanted to do. And now, we're really focusing on getting a very meaningful deal with one of the big vet players and we'll keep the market updated on that. But I think overall, the big launch was everything we wanted it to be and it was a very good success.

And sales, as we've seen, is steady, which I think we're also happy with, because we have not done our own launch. We do not have a sales team; will have no one on the sales side. So it's been ticking over at a very steady pace, but the focus really is on a big vet deal, which I think would be quite transformational for the company as well as for the vet subsidiary.

Great.

And turning to clinical cancer, it's great news that EDRN, looks like it's proceeding again. And actually, just thinking about NHL diagnostic study in particular, we have this time line around submitting first data to the FDA in late 2022. Can you just help us think about what our expectations should be for that? And would that data maybe be sufficient to drive clearance in that indication?

Yes. So Jason can go through with you. There are many subtypes of NHL and I'll let him go through all those with you. But the biggest ones, it can be potentially done in that time scale of next year and then submit to the FDA, which would be a product launch in 2023. And I think once the trial is in full swing and collection is going, it's obviously not going to take a huge amount of time. The delay has just been very understandable in pandemic. It's tough getting protocols and collection is obviously difficult; and particularly, in the longitudinal study as well, where you're trying to get fix -- talk to the same person to come in 6 times during lockdowns and pandemics, it can be very problematic. But I think -- yes, so, end of next year, I think, is very achievable. That's our target date and that would be enough for the first FDA product if it was successful to launch in 2023.

And as you can tell, on the Vet side, the human blood cancers are very similar to the dog ones, to the animal cancers. The data has been very, very good on the Vet side. The product has been received extremely well and the data is very similar to what we have now in the human side. And the need is also very strong in the humans. It's about -- all combined, about 5% of human cancers. So it's a very -- a cancer, which is -- we could be very helpful in, and it's also one where there's absolutely not a really good current way to directing towards a biopsy. So I think it could be a very good product as well. So we'll keep you informed. But our U.S. team, led by [Dr. Tom], has been working on this a lot to really push it through.

Next question is coming from Steven Ralston from Zacks.

To drill down to the Nu. Q Vet, it seems like you've established a steady base on the revenue side there, as you proceed to get into a partnership arrangement. In your in-house sales effort, which you're not going to build on, but exists, it seems as if that your customer base was primarily in Texas. And I'm wondering if there's going to be some just natural geographic expansion there with all the new information that you're pushing into the veterinary field, the abstracts, the papers, attending these conferences; and whether you would have veterinarians, outside that small geographical area, contacting you to utilize your product?

So, yes on all of the answers. So yes, the interest has been good. Yes, it's been focused on Texas because that's where the beta launch was. We had not spent much time or effort and have no salespeople pushing the product. This was targeted to have the teaching, so we can do a national launch. But I think that you can try and grow organically like that. But I think, given in our opinion and I think it's well backed up, this is potentially a very big mass market product in the millions of tests per year, which for the entire product, would be hundreds of millions in revenue per year to be shared around by a few parties, but [as we finish with our first product].

Our focus really is on getting a partnership because -- I wouldn't mention names -- we're obviously in very serious discussions, but all the obvious candidates are very keen. Some of them have getting close to 1,000 salespeople worldwide and many different countries. Their interest would often be exclusive, whether we give that to them or not. It depends, I guess, on how aggressive they're going to be and what they can pay us. Each one has better focus on either point of care or vets themselves, or laboratories, so each partner comes with benefits in different areas.

And Tom, being in the industry his entire life, obviously, knows them all very well and knows the chief executives of all the companies we're talking to. So I think I wouldn't necessarily see it as an organic growth coming out of Texas now, I think, hopefully. I mean no-deal has been signed. So I mean, we're hopeful and it's looking very good. But we do not have to sign a deal if we do not want to; we can launch ourselves, as you said, and grow organically.

But I think the potential to grow very quickly is much higher when you're with a company that could be worth $60 billion to $70 billion, as some of them are, and even one of the smaller companies with point-of-care specialists that's worth several billion dollars just for this one product area. So I would look at it much more as getting a deal hopefully signed, as Tom said, this year, and then really launching quickly. Now if that doesn't happen, for whatever reason, and that's certainly possible, we will continue to grow. We'll hire the first sales group and push out on our own launches, but I think the best, quickest and easiest way to get this is mass market products. And so, we can also focus on all the other things we're doing in the NETs, in the human cancers and put all our effort into that would be a licensing deal. And as I said, they're going very well, those discussions. So keeping the air up for the rest of the year, but something we're hopeful about.

And looking forward to the other potential revenues in the second half of 2021, in Nu.Q Discovery, you mentioned that you've provided multiple quotes to several pharmaceutical and biotechnology companies.

That's correct.

Generally, what is the timing on them considering these quotes, and going and deciding to go forward with them?

That's a good question, actually. And that's actually something Terig is going to have to work through on the revenue recognition side. But we do have a handful of quotes. Some of them are quite chunky. And in aggregate, that's certainly in hundreds of thousands of dollars. Now how many of them actually have come through, how many can we book this year, if it's a year program. Obviously, you have to book the revenue every year or 2. All those things, we'll have to report in the accounts.

And as I mentioned on the call, quite often with these things, they can start in the tens of thousands, and if it all goes well into few years, that could be in the millions, if it continues through. But for where our revenue is at the moment, obviously, hundreds of thousands in quotes with very real companies is a good start. If we convert a fair percentage of them, it will be a reasonable amount of revenue over the next 12, 18 -- 2 years and hopefully growing. Because I think, as I discussed before, I think we have something very special.

Epigenetics is really taking off. Our platform now is very, very stable. We have over a dozen assays; we can run on an auto analyzer now, detect different signatures on the nucleosomes as well as potentially revenue coming from the mass spectrometry in Capture side as well as are running samples as well as selling nucleosomes. So I think that could get quite interesting. But I think this year, depending on how many quotes are converted. And as with many things, they speed up and slow down. And --but when you have quite a few of them going at the same time, we're quite confident we can book some revenue this year and show strong going through next year.

Our next question today is coming from Jason McCarthy from Maxim Group.

This is Michael Okunewitch on for Jason.

I'd like to ask, just in your press release over here, you do mention, later this year in NETosis, you're expecting a few readouts from some larger trials in the coming months. I'd like to see if you could give us a bit more color on what data points we could expect from those studies?

Yes. So just as an example of what -- how long -- now that we release results typically through a publication, a peer review publication or a conference, sometimes there's a lag time. So for example, the great data that came out from Kings and St Thomas' in London was ready in February, but not presented at the conference in July; it's just the way conferences work. And I can't talk too much about them because they're not public yet. But obviously, there's a lot of work been going on in the last few months, which are in the process of being published and will be published later this year.

There's a very wide range. I think NETosis is really quite spectacular in its opportunity. I say that because if you look at the conditions where NETosis is a main or a big driver, in sepsis, influenza, COVID, it looks to be a primary driver in the metastasis of cancer, heart attacks, strokes. I mean it's just quite amazing how many things our assays could be useful in. And as you can see -- I'm not sure if you had the chance but if you haven't done -- I strongly recommend to read the abstracts that were from July; it's quite remarkable; the potential uses that our assays could have. And again, this is only the start. This is just the first ones that we have ready. There's a lot of epigenetic signals, the NETs themselves and related to all this.

But it's something which if you have a high level of NETs, it's not good for you. For example, in sepsis and COVID, it can be hundreds of times a healthy person's normal level if you're in Intensive Care and it's not good news. So I think it's something, which a lot of people want to or a lot of hospitals who want to know what the NET level are of everybody in the hospital, because sepsis can kill you if it comes on to you quickly and it's not really seen. So all of our trials and we're working in a range of different areas.

We did a lot of work on COVID for obvious reasons. But finding a trial for products been a little problematic because when the hospital was very busy, they're very, very busy, and getting to collect samples for a trial is problematic. Sepsis, unfortunately, is in every hospital every day, so collecting large numbers of samples is obviously not as challenging; and it's not seasonal or a variant related like COVID spikes seem to be. So we're doing a lot of work on that.

And also broadening into the other areas, where NETosis is known to be quite strong, as I mentioned, including cancer. And as you probably remember, we also have a relationship with Santersus in the monitoring of -- and treatment of NETosis, are using blood plasmapheresis to remove NETs. So expect to see some data on that this year as well. And potentially, if it goes through, well it would be a fantastic publication; if using our assays to monitor, they can show that they can remove NETs; they've been doing it in pigs; and now, they've had the first human -- human is being treated. So there will be a lot of data we expect on the bits of the COVID, sepsis and all the other conditions through the rest of the year.

I can't tell you too much more because they're obviously being run now and in the process of being either prepared or published. But it's definitely picking up space -- picking up speed in the space and there'll be a lot more data. And -- but we're also focused. We don't just want to keep producing more and more fantastic data. We're very mindful. We're a product company now and we're looking at all the different ways we can make products. So expect some news on that as well.

All right.

And then I'd just like to touch briefly on lung cancer, specifically, you have the NTU data coming later this year and that's a pretty large data set. So I'd like to ask what would be the next steps after the NTU data for getting the first human lung cancer product to market?

That's a good question, Michael, and something we're looking to do. Obviously, that partially depends on the data. As you probably remember, the initial data was encouraging or quite encouraging. And it was looking at low-dose tomography as well as a general test. It's quite a remarkable study. There was close to 1,000 lung cancer samples in there, which is, as you know, is huge for a study. That's something we're working through. It's not something I have an answer for today. We'll process the data. So the finished collection, which is fantastic, and quite an accomplishment during the pandemic. As you know, a lot of places have not managed to do that, but Taiwan has. And also -- but what they're doing now, this trial is 1,200 samples and there's 7,000 on the colorectal side. So at the moment, they're collating the clinical data, which -- when you're looking at thousands of different patients -- can take some time, but we're analyzing the sample data now.

Once we've seen that data, we'll see what questions have best been answered by it and make a decision on how we commercialize. But as I said before, we're hopeful because the early data was very encouraging. But we do not have a current clinical path for that product like we did for the other ones. We'll wait and see the data and make some decisions then.

We've reached end of our question-and-answer session. I'd like to turn the floor back over to management for any further closing comments.

Thank you everyone.

It's been an exciting start to the year. I think it should be an even more exciting end of the year, where we've got a very strong commercial focus now. And I'm very hopeful to have some very good news on a range of different areas, including commercialization in the coming months. And I look forward to updating you as they happen. Thanks for your time.

Thank you. That does conclude today's teleconference webinar. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.