VolitionRx Limited (VNRX) Q2 2021 Earnings Report, Transcript and Summary

Hello, and welcome to VolitionRx Limited Second Quarter 2021 Financial Results and Business Update Conference Call and Webcast. At this time, all participants are in listen-only mode. [Operator Instructions] A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is 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 the 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 would 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 any 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 especially appreciate it, given the busy you all are during the earnings call season. And speaking you are 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 four key pillars. Nu.Q, Nu.Q Vet, Nu.Q NETs and Nu.Q Capture. I’m delighted that Dr. Tom Butera, Chief Executive Officer of our Veterinary Subsidiary is joining us to update on the fantastic progress and upcoming plans for Nu.Q Vet. To start off however, I will quickly hand over to Terry 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 aftermarket 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 to 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 [DLO] (Ph) deals, if any. And so, the company continues to be in a strong cash position, providing a 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 steal Tom’s thunder, but given the interest we are seeing in the Nu.Q Vet products 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 book sales. Last but not least, our new commercial team continues building a solid pipeline of sales opportunities with interest developing to Nu.Q Discover, our sample processing service for external parties, such as pharmaceutical companies, biotech companies and academic researches. 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’m delighted to have such a strong cash position which still are consistently low burn rates, providing us a 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 for one or more 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 and families plus three in licensed families, 10 granted patents in the U.S. 14 in Europe and total 47 patents granted worldwide. We also have 89 patents pending. On XP publications. Given our comfort with both our IP position and the stability and robustness of our Nu.Q platform, publication and abstracts remain one of our key objectives and our recent publications and abstracts continues to grow. Starting with our veterinary team, our second clinical paper was published in respect to the BMC Veterinary Research at the end of the quarter, with a third clinical paper accepted in due for imminent publication now. Our fourth paper will be submitted later this month, detailing new clinical data for Nu.Q Vet Cancer Screening Test, broadening its application to seven of the most common canine cancers. Also on the veterinary side, we have had two abstracts accepted for the Veterinary Cancer Society meeting due to be held in October. We would showcase a lot of new data, firstly, using our Nu.Q assay to monitor both disease progression and treatment response in dogs with cancer. And secondly, using 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 ANM University. Well done you all. Also published this quarter, in Nature’s Scientific Reports was a fundamental research project led by professor Stefan Holdenrieder, with some physician 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 this cell-free DNA and cell-free DNA biology by measuring and comparing in three different cell lines. Total cell-free DNA, fragment sizes and epigenetic profiles of nucleosomes. In the aim to develop comprehensive clinical assay. I’m 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 two collaborators from leading UK hospitals using the Nu.Q NETs assay in COVID 19 studies. These proceeds included early stage data showing that results with the Nu.Q NETs on admission could predict the future COVID-19 disease severity and that serial results correlate with disease progression. A fantastic results, I’m grateful about it 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 a rigorous approach to present data where we can, in either peer reviewed papers or at conferences. However, it does mean a lag time to study results of public patients. By way of example, the data from these two 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 posted in abstracts in the second half of this year. And so, to our product updates. First, our Nu.Q NETs. As a reminder, we believe that 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 stratified patients for treatment selection. We have previously reported preliminary results demonstrating that our Nu.Q NETs assay correlated well with current COVID-19 disease severity. The recently published posters showed that early stage data with the same assay demonstrated that results on admission could predict future COVID-19 disease severity, and that series 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 patient’s required care in a general ward or organ support in an intensive care ward. The study results also indicated the 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 maybe a value in risk stratifying patients for treatment for 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 tracks the clinical course of COVID-19 patients admitted directly to intensive care, admitted 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 maybe 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, I look forward to continuing this positive dialogue. 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 is something where I need 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 had 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 next products worldwide. Given the numerous potential commercial uses that we have identified to-date and our expectations for further identified users. We have also expanded the team to include a very experienced industry professionals to help us with this process. We aim to launch our first commercial [CMX] (Ph) NETs product in 2022 and to outline the strategy for an FDA approval of NETs 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 Miles 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 joined the call today. Busy first three months in my new role but tremendously enjoyable and rewarding. I would like to start off by complimenting the Volition team and the researchers of Texas ANM University, led by the incredible Dr. Heather Wilson Robies on a great work they have done in developing a simple, easy to use broadcast to address a huge unmet need in 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 to significantly help transform help veterinarians manage cancer and companion animals. Early diagnosis of cancer has the potential to help improve the treatment and quality of life as well as providing valuable visual information to inform the clinical decision making process. I have 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 our veterinary team to-date. There are numerous clinically relevant concepts we have for future programs and I believe that we really are only at the very beginning with a 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 depicted 82% of hemangiosarcoma cases had a very high specificity of 97% the test protects all stages of the disease with unsurprisingly nuclear zone concentration levels increasing with disease severity. A second data was 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 from Nu.Q Vet in detecting a very high proportion of lymphomas patients, again the same specificity. The clinical team has also completed the analysis of over 600 K-9 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’m happy to say that, nucleus levels were evaluated in plasma samples from patients with seven of the most common K-9 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 topic. Dr. Wilson also new data as an invited speaker at ACVIM forum in June. This is a closed meeting, so the proceedings are not reported. However, in 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, but 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 to expand the clinical utility of the current Nu.Q Vet Cancer Screening Test in addition to fueling new product development for the monitoring test. We are continuing our work with several veterinary university teaching hospitals to collect samples from additional cancers, as well as other noncancerous conditions, such as inflammatory conditions, benign masses and endocrinopathies, et cetera, to determine how they may affect the plasma Lubrizol compartment. This data may help us to better differentiate between cancer and other diseases and help to provide further, very relevant products in 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 is smaller than usual due to the pandemic, it was also a virtual format available and we had great interest in our Nu.Q Screening Test. We were delighted to be featuring Dr. Sue Ettinger aka Dr. Sue Cancer Vet presentation entitled What’s New In Cancer 2021. Shu is just a great speaker and a great advocate for us, and we will be filming some of Nu.Q case studies soon. We have a busy program planned through late summer and the fall too. We will be presenting the 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 engaging an important dialogue 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 the 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 groups. And so for more commercial update. In terms of commercial opportunity in the addressable market, cancer in dogs is widespread. It is a leading cause of death for dogs over the age of 10, and there are over 6 million new dogs 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 the various pets and the owners is there. The Nu.Q Vet Cancer Screening Test is positioned for use during the Annual Preventative Care Wellness Test for older dogs. Seven years and older, and for dogs from four years and older of Atlas breeds such as Golden Retrievers. Approximately 80% of dogs visit the veterinarian each year, and according to the ADMA in 2016, it 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 and few products. Interesting though, I think likely the most valuable contribution from the beta launch has been the high level of interest it has drawn 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’m 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 knowhow on scientific breakthroughs and 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 we are certainly at the business end of negotiation with a number of prospective partners. We hope, and I know all of the prospective licensers hope that, terms to 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 will 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, I have been incredibly impressed with the quality of the work completed to-date and the exciting plans we share. And with that, I will 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 will 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 Scientific Reports, which details our novel proteomics approach to epigenetic profiling of circulating nucleosomes in the blood of cancer patients. We believe that Nu.Q Capture technology will be useful not only when using combination with mass spectrometry to discover new biomarkers as per this paper, but also as a DNA enrichment technology, which could aid diagnosis, treatment selection, and both treatment and disease monitoring when using combination with either sequencing and/or our Nu.Q assays. The Nature 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, 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 - 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 nodes 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 the there. We are 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 abstracts. Were also running the essays and finalizing the analysis for the CRC study, and anticipate these filings will be presented at a conference in 2022. As previously reported, collections 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 two us 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 have had with EDRN, we are closely monitoring the ability of clinical sites to perform the study as COVID restrictions dissipate, while ensuring pre-analytical and logistical procedures aligned 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, later in 2022. COVID restrictions have also made sequential therapy match specimen collections exception 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 launched in China. We will of course keep the market updated on any successful transaction being closed. As discussed on previous calls. Following the urging 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 new to discover and I 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 Nu.Q assays to monitor the efficacy of customers therapeutics, in development for cancer, the NETosis and other theories 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 essays are proven as companion diagnostics through our customers therapeutics, and so for the future. I would love to reiterate, our vision and what makes us so excited with the progress in our space. Volition is an epigenetic 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 it is coming to fruition with our Nu.Q platform as a very hot epigenetics. We have believe the last decade of work of Volition without ever expanding team in epigenetics puts us in an extremely strong position with our expensive IP portfolio 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, a whole team is incredibly excited about 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, but with exclusive purpose on Nu.Q Vet with the aim of signing the first deal or deals this year. Two, Nu.Q Discover processing samples at 201 using our Nu.Q discovery essays and three, disease monitoring tests such as COVID-19 and sepsis. We also aim to publish data on multiple fronts across our four 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 are happy to take questions now. Operator.

Thank you [Operator Instructions]. Our first question today is coming from Bruce Jackson from Benchmark Company. Your line is now live.

Hi. Good morning. And thanks for taking my questions. So, if we could just talk a little bit about Nu.Q Capture product line. The paper in nature of course is initial milestone for you after potential applications here. Have you gotten any like inbound interest from people who want to work with you on this, on either in their own labs or with Silver One?

Yes. Good question, Bruce. So Nu.Q Capture project, we have been making progress, I guess, on the two fronts. So, it is split into the sequencing and mass spectrometry. So, as you I’m sure read the paper that the paper was on the mass spectrometry side, so we are starting to generate some interest on that side and it is really encouraging. The sequencing side, who we hired. I think you remember, and you met Dr. Terry Kelly in California. She has been building a team to fully optimize that process as well. So, it is too early on the mass spec side because it is like our essays. We have had to spend a lot of time, making sure it is 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 interest. But the commercialization focus given Capture is still very much work in progress has been less of an effort in the Vets, in the NETS and the human cancer side. Because as with everything else, we want to make sure it is fully optimized and then quite reproducible before we really start marketing aggressively. But there has been some interest on the mass spec side didn’t come in interest, but I wouldn’t expect for us to put a lot of effort into the Capture side commercialization until it is fully optimized. So hopefully sometime in the next 12-months, but I guess we will see how the optimization goes.

Thank you, great. And then moving over to the NETs, you outlined the FDA regulatory strategy really quickly. I was hoping if you could just go through that again. I didn’t quite catch if there is - you are going to have the strategy by the end of this year, or it is going to be - or if you would just submit by the end of the year? If you could just run through that one more time, I would appreciate it.

Actually, not submitted by the end of the year it is the strategy. So I think on the Nu.Q NETs side, we have been very happy with the data and the fantastic collaborators we have had. And it ends up incredibly well. Our team and our collaborators are exceptionally happy. Now, we are in the process of working out. I think to put it in one way, we are sipping from a vial of opportunities. So we are following a little what we have done on the Vet side. We have strengthened the bench with an industry professional, we start soon. We have had great data with collaborators. Our strategy would be a very similar one in a sense we will launch our own products. But also look to use it in a wide range of areas with other industry players, other collaborators. So to outline, we are 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 a CRO, on working on their own 510-k study alone. And we have 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 FDI work and outline our strategy this year. And on top of that, we are looking of course on European strategy, which our new hire who is Ex Roche for decades is helping us with as well. Does that answer your question Bruce?

It does. And thank you so much. I will hop back in the queue.

Thank you Bruce have a great day.

[Operator Instructions] Our next question is coming from Nathan Weinstein from Aegis Capital. Your line is now live.

Good morning and thanks for taking my question. So perhaps if you could start with Nu.Q Vet and just would appreciate sort of a general view into the beta launch, how that is going, any reception, reorder rate or anything you can say to kind help us understand how that is proceeding would be great.

Yes, absolutely. So I think as Tom very well put, it is done everything we wanted it to do. It was done to make sure were all the aspects were 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 the very major players, their interest has been 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 a strong focus now is to license through one of the big collaborators, as you 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 have 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 better. 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 good deal with the vet company, because we can launch ourselves. And we have 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 is a fantastic platform, it is a domestic market easily, we think it is easily several million tests a year, which is potentially hundreds of millions of dollars in revenue. So, even for the one of the big vet companies that move the needle. So yes, so it did everything we wanted to do. And now we are really focusing on getting a very meaningful deal with one of the big vet players. And we will keep the market updated on that. But I think overall, the big launch with everything we wanted to debate was a very good success. And sales as we seen a steady, which I think we are also happy with because we have not done a right launch. We do not have a sales team, we have no one on the sales side. So, it is been ticking over at a very steady pace. But the focus really is on a big deal, which I think would be quite transformational for the company, as well as for the vet subsidiary.

Great. Thanks, Cameron. And turning to clinical cancer. It is great news that EDRN looks like it is proceeding again. And actually just thinking about NHL diagnostic study, in particular, we have this timeline around submitting first data to the FDA in late 2020. Can you just help us think about what our expectations should be for that and when that data may be sufficient to drive clearance in that indication?

Yes. So, Jason can go through with you there are many subtypes of NHL. And I will let him go through all those review. But the biggest ones, we can be potentially done in that time scale 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 collections going, it is obviously not going to take a huge amount of time. There is just been very understandable in pandemic, it is tough getting protocols, and collections, obviously difficult. And quickly in the longitudinal study as well. Were you trying to get the - type person to come in six times during lockdowns and pandemics. And it can be very problematic. But I think, yes, so in the next year, I think very achievable. That is 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 sides, 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. What we have now in the human side, and the need is also very strong in humans. It is about all combined about 5% of human cancers. So, it is a very cancer, which is if we could be very helpful in and it is also one where there is absolutely no really good character way to directly towards a biopsy. So, I think it could be a very good product as well. So, we will keep you informed, but our U.S. team led by Dr. Trellis and working on this a lot to really push it through.

Great. Thanks Cameron. Thanks for taking my questions. Much appreciated.

Thanks Nathan.

Thank you.

Thank you. Next question is coming from Steven Ralston from Zacks. Your line is now live.

Good morning or good afternoon where it is the case maybe. To drill down to the Nu.Q Vet, it seems like you have 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 are not going to build on, but exists, it seems as just your customer base was primarily in Texas? And I’m wondering if there is going to be some just natural geographic expansion there, with all the new information that you are pushing into the veterinary field, the abstracts, the papers, attending these conferences and whether you would have veterinarian’s outside that small geographical area contacting you to utilize your product.

Yes. So, yes, on all of the answers. So, yes, the interest has been good. Yes, it is been focused on Texas, because that is where the beta launch was. I would have not spent much time or effort and have no sales people pushing the product. This was strategic so we can do an extra lunch. But I think that, you can fund grow organically like that. But I think, given in our opinion, and I think it is well backed up, this is potentially a very big mass market products in the millions of tests per year, which for entire product would be hundreds of millions in revenue per year, to be shared around by few parties. But, this is the first product, our focus really is on getting a partnership, because I wouldn’t mention names. We are obviously in very serious discussions, but, all the obvious candidates are very keen. Some of them have getting close to a thousand salespeople worldwide, and many different countries. Their interests would often be exclusive, whether we give that to them or not, it depends, I guess, on how aggressive they are 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 an industry his entire life obviously knows them all very well and knows the chief executives of all the companies we are talking to. So, I think I wouldn’t necessarily see it as a organic growth coming out of Texas now. I think, hopefully, I mean, no deal was being signed. So, I mean, we are hopeful and it is 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 are with a company that could be with $60 billion or $70 billion, as some of them are. And even one of the smaller companies with reporting care specialists with 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 is certainly possible, we will continue to grow. We will hire first sales group and push out on our own launches. But I think, the best quickest easiest way to get this as a mass market products. And so, we can also focus on all the other things we are doing in the nets and the human cancers, and put all our effort into that would be a licensing deal. And as I said, that they going very well in there is discussion. So, keeping you up for the rest of the year, that is something we are hopeful about.

Thank you. And looking forward to the other potential revenues in the second half of 2021 in Nu.Q discovery. You have mentioned that you have provided multiple quotes to several pharmaceutical and biotechnology companies. Generally, what is the timing on them considering these quotes and deciding to go forward with them?

That is a good question, actually. And that is actually something Terig is going to have to work through on the revenue recognition side. But we do have a handful of requests. Some of them are quite chunky and in aggregate, it is certainly in the hundreds of thousands of dollars. Now, how many of them actually come through? How many can we book this year? If it is a year program, obviously I have to book the revenue over a year or two. All of those things we will 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 in a few years, they 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 I think two-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, it is very, very stable. We have over a dozen assays we can run on auto analyze them now, detect different signatures on the nucleosomes as well as potentially revenue coming from domestic promontory and Capture side as well as running samples, as well as selling nucleosomes. So I think that could get quite interesting. But I think this year, and depending on how many quotes we converted and as with many things, they speed up and slow down. But when you have quite a few of them going at the same time, we are quite confident that we can book some revenue this year and show strong growth for next year.

Thank you for taking my questions.

Thank you Steven.

Thank you. Our next question today is coming from Jason McCarthy from Maxim Group. Your line is now line.

Hey, this is Michael Okunewitch on the line for Jason. Just in your press release over here, you do mention later this year in NETosis, you are expecting a few readouts from some larger trials coming in the coming months. So I was wondering 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 now that we released results, typically through a publication, a peer publication or a conference, sometimes there is a lag time. So for example, the great data that came out from [Lancet] (Ph) Thomas in London was ready in February, but not represented the conference in July, just the way conferences work. And I can’t talk too much about them because they are not public yet, but obviously there is 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 is 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 big driver, in sepsis, influenza, COVID, it looks to be a primary driver in the metastasize of cancer, heart attacks, strokes. It is just quite amazing how many things our efforts 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 read the abstracts that were from July. It is 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 is a lot of epigenetic signals on the NETS themselves and related to all this, but it is something which, if you have a high level of NETS, it is not good for you. In example in sepsis, in COVID, it could be hundreds of times a healthy person’s normal level, if you are in intensive care and it won’t renew. So, I think it is something which a lot of people that want to a lot of hospitals want to know what the next level are everybody in the hospital, because sepsis can kill you if they comes on too quickly. And it is not really seen. So, all of our trials, and we are 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 is very busy, they are very, very busy, and then 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 is not seasonal, or a very related like COVID spikes tend to be. So, we are 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 relationship with centers in the monitoring of and treatment of NETosis, or using blood plasma for -- to remove nets. So expect, we have been better on that Nu.Q as well, and potentially, if it goes through what would be a fantastic publication. If using our essays, to monitor, they can show that they can remove nets, they have been doing it in pigs, and now they have had the first human, humans being treated. So, there all 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. Like I can’t do too much more, because they are obviously being run now. And they are in the process of being either prepared or published. But it is definitely picking up space, taking up speed in the space and we will get more data. But we are also focused, we don’t just want to keep producing more and more fantastic data. We are very mindful. We are a product company now. And we are looking at all the different ways we can make products. So, expect some news on that as well.

Alright, thank you very much. And then I just like to touch briefly on lung cancer specifically, Nu.Q data coming later this year. And that is a pretty large data set. So, I would like to ask what would be the next steps after the Nu.Q data for getting into the first human lung cancer product to market?

That is a good question, Michael. And something we are looking to do. Obviously, that partly depends on the data. As you probably remember, the initial data was encouraging or encouraging. And it was looking at low dose as well, as a general test. It is quite remarkable study that was close to 1000 lung cancer samples, which is, as you know, is huge for a for study. That is something we are working through, it is not something I would have an answer for today, will process the data. So the finished collection, which is fantastic, and quite an accomplishment during the pandemic, as a lot of places have not managed to do that but Taiwan has. And also, but what they are doing now, this trial is 1200 samples, and there is 7000 in the colorectal side. So at the moment, they are collecting the clinical data, which we are looking at 1000s of different patients can take some time, but we are analyzing the sample data now worth reviewing that data. We will see what questions had best been answered by it, and then make a decision on how we commercialize. But as I said before, we are hopeful because the early data was very encouraging. But we do not have a current clinical path for that product, like we do for the other ones. We will wait to see the data and make some decisions.

Alright. Thank you very much Cameron.

Thank you Michael.

Thank you. We have reached the end of our question-and-answer session. I would like to turn the floor back over to management for your further closing comments.

Thank you everyone. It is being exciting start to the year. I think you should be even more exciting in the year, where we have got a very strong commercial focus now and I’m very grateful to have some very good news on a range of difference 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. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.