Volitionrx Ltd Q4 FY2020 Earnings Call

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited's Fourth Quarter and Full Year 2020 Earnings Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be opened for questions. This conference is being recorded today, March 23, 2021. I'd now like to turn the conference call over to Mr. Scott Powell. Please go ahead, Scott.

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 fourth quarter and full year of 2020, 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 recently appointed Chief Financial Officer; and Dr. Jake Micallef, our Chief Scientific Officer. 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 any obligation to update any forward-looking statements made during the course of this call. I'd now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thank you, everyone, for joining Volition's conference call today. I especially appreciate it, given the busy earnings call season. I'd like to start yet again by recognizing the amazing commitment and hard work done by all of our teams over the past few years during these difficult times. I could not be prouder of their efforts. Despite the lockdown, we have managed to keep our main lab operational and opened the new Silver One production facility, and indeed have made significant progress in many areas of the business throughout 2020 and into the first quarter of 2021. Now that we have a stable, reliable, reproducible platform technology that we think can and will be highly disruptive and influential worldwide in a wide range of areas. Before passing over to Terig, who will cover the financials, and then moving on to our product launches, I will start today by briefly discussing our 2020 highlights and a reminder of all the progress we have made in the last year. We have traded this year strongly, especially by closing our acquisition of Optima in January and then by launching our first product, the Nu.Q Vet Cancer Screening Test in December and achieved many exciting milestones in between. The strategic acquisition of Optima helped secure the supply of one of the key components of our Nu.Q tests, the recombinant nucleosomes, which we use as the calibrants. The transfer of know-how is now complete, and we now have the capability to manufacture a wide range of these key components in-house. 2020 was a pivotal year for the Nu.Q test. It's truly remarkable to reflect that we only reported the proof-of-concept data in April of last year. By the Veterinary Cancer Society conference in October of 2020, we published all study results and hosted a key opinion leader roundtable event. By year-end, most of the Nu.Q Vet Cancer Screening Tests were developed in collaboration with Texas A&M. This is all a fantastic team effort, and our focus on near-term product launch opportunities during the pandemic shows the amazing flexibility of our platform and team. This flexibility is a key aspect of our success. Throughout the year, we continued to strengthen our large intellectual property portfolio, with additional patents being granted and new patent applications submitted, including in relation to the use of Nu.Q technology in NETosis, COVID-19, and other diseases. We now hold 64 patents worldwide, with a further 90 patents pending. We also published and/or presented at several conferences, most notably at ASCO 2020, with various abstracts featuring performance data on our Nu.Q technology with respect to lung cancer and blood cancer, as well as performance data for Nu.Q Capture. At our Virtual Markets Day in October, we announced our commitments to two lung cancer studies to be conducted in the U.S. The first of these studies is a large-scale regulatory study involving up to 1,500 subjects into the five most common types of Non-Hodgkin's Lymphoma. The second is a proof-of-concept study for the monitoring of treatment response for the most aggressive NHL cancer, DLBCL. Both studies are now underway, with results from the treatment response study expected later in the first half of this year, and likely the first readout from the NHL regulatory or 510(k) study within the next year. We have had an action-packed 2020 and have much to review from the start of 2021. But before I go into more details, please allow me to introduce our new Chief Financial Officer, Terig Hughes, who will take you through the key financial results for 2020 and provide an update on the recent financing transactions that have significantly strengthened our cash position. Terig, great to have you on board, over to you.

Thanks very much, Cameron. And thank you, everyone, for joining our earnings call today. I look forward to meeting many of you in person when possible. I will now provide a summary of the key financial results. For the year ended December 31, 2020, we reported a net loss of $20.4 million compared to a net loss of $16.1 million in the prior year. This result was predominantly driven by higher research and development spending, which increased by $4.2 million over the prior year period to $14.5 million in 2020, reflecting the investments we made in expanding our team and securing the supply and manufacture of key components through the Optima acquisition, as well as higher research spending directed at COVID-19 and NETosis. Despite this higher level of spending, we closed out 2020 with cash and cash equivalents of $19.4 million, compared with approximately $17 million at the end of 2019. To add to this, during the first quarter of 2021 to date, we have significantly strengthened our balance sheet by adding approximately $20.5 million in cash through an underwritten public offering of our common stock in February, as well as through our aftermarket equity distribution program. Furthermore, in January, we were delighted to announce the award of approximately $4 million in non-dilutive funding from the Walloon Region and Namur Invest. We have a long history of support from the agencies of the Walloon Region, who to date have awarded Volition approximately $13 million in non-dilutive funding, including this most recent award. To recap, before taking into account the expenses we have incurred thus far in 2021, our cash and cash equivalents totaled approximately $40 million, which is by far the strongest cash position we have ever had in the Company's history. Nevertheless, we continue to manage our expenditures carefully. Our burn rate through the final quarter of 2020 was an average of approximately $1.5 million per month. Overall, we would expect it to increase slightly as we make additional investments toward our product launches and expansion of our platform. I will provide periodic updates on our future earnings calls. In summary, we're in a strong financial position, providing us both a great runway to achieve our many milestones and continuing flexibility to weather the pandemic. With that, I will pass back to Cameron for further operational and product updates.

Thanks, Terig, and I'm absolutely delighted to have the strongest balance sheet we've ever had and great to have you on board. In fact, while talking about team members, I'd also like to publicly welcome Ms. Gael Forterre, our new Chief Commercial Officer, to our executive management team, as well as congratulate Gaetan Michel for his promotion to Chief Operating Officer and Dr. Mark Eccleston, one of our founding advisors, for his promotion to the newly created role of Chief Technology Officer. As we are transitioning from a research and development company to a commercial company, we are proud to strengthen the leadership team with these key appointments. All four bring strong global expertise and experience to their respective roles, and these appointments aim to provide a very strong product focus for our management team. Also, from an expansion point of view, we're absolutely thrilled to have opened Silver One, the production hub for our products and components close to our lab in Belgium. I'm very happy to announce today that we are now producing several of our key components and plan to achieve full ISO certification later this year. As with our previous real estate transactions, the vast majority of the purchase and fit-out costs were supported through non-dilutive grants and loans from the Namur Region, again helping to keep our burn rates relatively low. We are well into the process of producing at large scale, raw materials such as recombinant nucleosomes, which act as calibrants in our Nu.Q assays, in addition to antibodies that are key elements to our branded products, and indeed, we will manufacture our full diagnostic kits once finalized. We expect to offer all elements for both commercial sale and for clinical trial purposes and CE-marked products for sale in Europe and beyond. We're also installing a service lab in the new Silver One facility, which will undertake sample processing for external parties, including sample processing for Nu.Q Vet in Europe. The opening of our new Silver One facility brings the manufacture of key components in-house, thereby securing our supply chain, but it also should definitely reduce the cost of production of any of these elements and should in turn reduce the cost of future assay development. It really is an exciting time, and I could not be happier that we could find a suitable site so closely situated to our current lab. Plus, it's another great step forward on our road for diverse revenue streams. Speaking of revenue, I was delighted to have appointed our first sales manager in Europe, Emmanuel Demillecamps; he started with us in December. Emmanuel brings over 25 years of sales experience in the diagnostic field having worked for companies such as Roche, Sanofi, and most recently, Vela. He has already proven to be an excellent addition to our team, with his focus to help drive revenue from our Silver One facility. Emmanuel has been hard at work generating initial revenues from our products in Europe, and we will update you with the results of his excellent work in our next quarterly earnings call in May. Finally, regarding organizational expansion, we opened a small shared laboratory at California State University, San Marcos in the fourth quarter. This lab is led by Dr. Terry Kelly, Chief Scientific Officer of Volition America Inc. and focuses on blue-sky innovation and discovery research, which we hope will help us leap forward in some of our cutting-edge research projects and lead us to our first product and revenue. Many of you have followed and supported Volition for many years, and know that it has been a long and winding road. The whole team was especially delighted to launch our first commercial product, the Nu.Q Vet Cancer Screening Test shortly after our 10-year company anniversary in the fourth quarter of last year. This is an extremely important milestone for the company. As this first launch, that we expect to be the first of many, demonstrates that our platform has reached a level of reliability and reproducibility to be launched in a completely independent laboratory. The test is positioned for use in both the annual health check for older dogs, those that are seven years and older, and for cases where there is a high suspicion of cancer. It may also be a complementary test for younger dogs or breeds at high risk for developing cancer in their lifetimes, such as Golden Retrievers. The test is currently available only from the GI lab at Texas A&M University, with the beta launch focusing on veterinarians across Texas. The beta launch is to facilitate real-world learning from actual customers paying for the test to help drive the marketing mix before we launch nationally across the U.S., as expected in the next few months. It also gives us a chance to showcase the product to the large multinational veterinary companies we are in very active discussions with, which if concluded successfully would help greatly accelerate launches and sales worldwide. This is our very first commercial launch, and we are using Texas as a test market to ensure all aspects of our products are adequately tested before launching nationally and worldwide, and to address beforehand any issues that companies who may end up pivoting or licensing out vet products might have. We are gaining extremely valuable feedback on key factors such as the logistics of a veterinarian taking a sample, shipping, processing, reporting and interpretation of the results, levels of customer service required, pet owner feedback, and of course, the optimal pricing at all levels. The team has also done an excellent job in starting to educate the KOLs, the key opinion leaders, and oncology specialists about Nucleosomics and raising general awareness of the Nu.Q Vet Cancer Screening Test. Cancer in dogs is widespread; it is the leading cause of deaths in dogs over the age of 10, and there are over 6 million new dog cancer diagnoses in the U.S. alone each year. As cancer screening is not as commonplace in animal health as it is in human health, we believe blood tests like the Nu.Q Vet Cancer Screening Test will help transform how veterinarians manage cancer in companion animals. Early diagnosis of cancer has the potential to help improve both treatment and quality of life, as well as providing valuable additional information to inform the clinical decision-making process. Our Nu.Q Vet Cancer Screening Test is a simple, low-cost, easy-to-use ELISA-based blood test, which we believe will help streamline the screening process for up to one-third of malignancies in dogs, including common malignancies such as lymphoma and hemangiosarcoma. We recognize the desire to receive revenue guidance given that we have our first commercial product and aim to provide this later in the year, as the mix of our own launches and licensing of our technologies to third parties in both the veterinary and human spaces becomes clearer. Sufficed to say, we are very happy with how the beta launch is going. It is providing us with absolutely invaluable information and our very first-ever product revenue. We have received the first product for our kits from the GI lab late last year, and since then, they’ve reordered kits twice already this year. In addition to the Texas beta launch, today with our global team, I'm delighted to say that we are finalizing beta launch planning in both Asia and Europe for our vet cancer screening test and expect a lot of news on these in the next few months. We're also continuing significant licensing discussions with well-known major players in the vet space around the world. I look forward to updating you on our progress in the coming months. We are at the very beginning; we believe that it’s a fantastic opportunity and are truly excited to start commercial operations. Moving on from the vet business to human cancers, where we are also continuing to make progress. In January, at the world's largest dedicated lung cancer conference, the WCLC, an abstract was presented by one of the members of the National Taiwan University team. The key message from this presentation is that based on an interim analysis of a subset of subjects in our ongoing study, Nu.Q assays could help identify non-cancerous nodules following a scan, thereby reducing unnecessary biopsies by as much as 32%. The results of this subset of the 1,200 subject study are very promising. Low-dose computed tomography (LDCT) is a widely accepted standard screening for individuals at high risk of lung cancer. However, LDCT has several limitations, including poor specificity, which means high false positives. Results of this study suggest that nucleosomes and histone PTMs may discriminate well between non-cancerous benign nodules and very early-stage lung cancers in non-familial lung cancer history patients. The ability to distinguish between cancerous and non-cancerous nodules could reduce both unnecessary biopsies and the frequency of radiation exposure from repeated LDCT scanning. Professor Chen, the study's Principal Investigator, said at the time of the conference that accomplishing this result through a non-invasive blood test would be an important step forward in lung cancer screening. Lung cancer remains one of the hardest cancers to detect, and there is a high unmet clinical need for improved diagnosis. We are hopeful that our Nu.Q assays can help and are delighted that our world-renowned collaborators presented this data at such a prestigious conference. We share our collaborative excitement to complete the study and report the findings when it is appropriate later this year. If it continues to go well, we will have our 510(k) regulatory study in the U.S., as we have in the blood cancers. We've also made great progress on the research program for the use of our Nu.Q technology in NETosis, particularly in monitoring disease progression of COVID-19 and sepsis. As announced earlier this week, we are exploring it as a potential companion diagnostic for treatment of sepsis, and we are looking to broaden this further into influenza and potentially other diseases associated with NETosis. To provide more context, I'll introduce Dr. Jake Micallef, our Chief Scientific Officer.

Good morning, Cameron, and good morning, everyone. It's great to be here. While cancer remains our core disease focus, given the relatively recent understanding of the prominent role of both NETs and nucleosomes in the pathology of COVID-19, sepsis, and many other diseases, we are also researching the use of our proprietary technology in diseases with particular regard to NETs and NETosis. In terms of background science, white blood cells help protect the body against infection by engulfing invading viruses and bacteria, and producing antibodies against them. In addition, white cells also eject chromatin material out of the cell to form Neutrophil Extracellular Traps or NETs, which catch and trap invading viruses. In a respiratory infection like COVID-19, white cells migrate to the lungs where they produce NETs to trap and kill the virus. This protects the lungs and prevents the virus from spreading throughout the body. NET is therefore a crucial part of the immune system. However, overproduction of NETs is pathological, and elevated levels of NETs are clinical complications of COVID-19, leading to poor patient outcomes, and can actually be fatal. NETs are similarly a complicating factor in a wide variety of other diseases, including respiratory infections, SARS and pneumonia, as well as metabolic diseases, autoimmune conditions, inflammatory conditions, cancer, thrombosis, stroke, and sepsis. The NETs material is made up of nucleosomes. I am bullish to have spent 10 years developing antibodies and assays for nucleosomes, so we are well-placed to take a leading role in much of this research. We can detect NETs in minute quantities using Volition’s Nu.Q nucleosome assays. Indeed, I believe our assays are the only analytically validated quantitative nucleosome assays currently available. We're investigating the use of the Nu.Q platform to monitor NETosis disease progression and treatment response across a wide range of diseases that involve the overproduction of NETs. Last year, we showed that nucleosomes were strongly correlated with disease severity in the first wave of COVID-19 patients. Patients admitted to hospitals had higher levels of nucleosomes than patients with mild disease, and patients requiring intensive medical support and intensive care units had even higher levels of nucleosomes than patients admitted to regular hospital wards. Patients who died had even higher levels of nucleosomes than patients in intensive care who survived. We have now conducted studies of serial testing in individual COVID-19 patients admitted during the second wave to determine how predictive our test is. This has taken longer than we expected, as the hospitals we are working with have understandably been focused on caring for the very high numbers of patients admitted during the second wave of the virus. We will announce data from human COVID-19 and sepsis studies over the coming quarters. In addition, we are releasing data from an animal study of sepsis this week in a presentation by Dr. Andrew Aswani, a consultant in critical care and anaesthesia at one of London's leading teaching hospitals. This small initial study looks at the use of Volition’s Nu.Q NETs assay to monitor treatment response to a novel therapy to remove NETs from circulation in a pig model of sepsis, resulting in improved physiological and biochemical well-being indicators. The results showed that the treatment was successful and that our Nu.Q assay was the best and most practical way to measure the NETs response. The studies are now progressing to investigate further animal models, and the first human trial is already being recruited. Following this success, we are investigating two further therapeutic antibody NETosis drugs, both in relation to treatment monitoring, and as a companion diagnostic for patient selection. While NETosis is still a relatively new field for Volition, given positive early results, this is shaping up to be potentially a significant new opportunity to utilize our Nu.Q platform. We have informed our Nu.Q NETs team to provide increased focus and drive to the product development program. It once again underlines the strong breadth of the Nu.Q platform technology, supported by our broad intellectual property portfolio. Exciting times ahead, with further data due to be presented at upcoming conferences. With that, I'll hand back to Cameron.

Thanks a lot, Jake. Exciting times indeed, and onto the future. I would like to reiterate our vision and what makes us satisfied with the progress and our sights. Volition is an epigenetics company focusing 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 at the very heart of epigenetics. We believe the last decades 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. 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 about the Company's future opportunities. We aim to report throughout 2021 and beyond numerous key milestones now that we're in full swing in turning our platform into a range of products worldwide. We will focus on driving revenue in the coming quarters where possible during the pandemic in four key areas: One, vet products; two, disease monitoring tests, such as in COVID, and sepsis; three, using our new production facility to drive reagent sales; and four, licensing of our technology for others to commercialize worldwide in both the human and veterinary space. We also aim to publish data on multiple fronts, including Nu.Q Capture, which I have not discussed at length today, but is also making very strong progress; five, along with the rest of the Board and the whole company, we look forward to sharing results of case studies over the coming months and year with our optimized platform. Despite the pandemic, 2020 proved to be a most exciting year, thanks to our fantastic hard-working team. But we are hopeful 2021 can top it. Thanks again for joining the call today. I very much appreciate it given the busy earnings call season. We're happy to take questions. Operator?

Thank you. And our first question is from the line of Kyle Mikson with Cantor Fitzgerald.

Just regarding the NETosis trial that you're still negotiating, I just had a few questions around that. So first, is the intention to conduct a trial that looks at all or maybe some of those diseases like COVID, influenza, sepsis, or will just one be examined in the trial? And then second, is it possible that the trial could assess treatment monitoring with NETosis-based therapeutic antibody drugs? I know Jake mentioned this and there are a few that you guys are looking at. I was wondering if that's a complication in the trial. And then finally, when you refer to a large trial, I noticed that in the press release, does that mean the size of the blood cancer study in the U.S.?

Those are very good questions. I'll answer those briefly myself and then see if Jake has anything to add. So, yes. The first question, really, I guess, pertains to whether we do a separate NETosis trial for COVID, for influenza, and for sepsis. We've been in discussions on those for influenza and COVID. But I think, given where we are, we’re probably more focused now on having one for sepsis because it's a very, very significant issue, as it's what kills most people in hospitals. Obviously, would be applicable, if it works in sepsis, it will almost certainly work in the others. But influenza and COVID, the numbers obviously fluctuate. While we are in the U.S., we're looking to do a large trial, which is probably going to be about the same cost we'd expect as the other 510(k) trials. This would likely involve a similar number of samples but less patients, if that makes sense, because you're looking to get four or five samples from these patients. So it would be a very similar scale of trial; the exact numbers you need for longitudinal studies we’re still working on. We expect to have a product for NETosis, which will work in sepsis; we hope to see how it goes, but based on everything we've seen so far, the results are very encouraging. So we're debating at the moment whether the first half of the study would focus on influenza and COVID, or whether we would prioritize doing one in sepsis. But sepsis is probably the big market and will continue to be an endemic issue. As far as regarding the drugs, we are looking at several therapies, and I believe, but Jake can confirm this, the trial for the drugs would be separate, as it's not diagnostic or prognostic or for disease progression. This would actually be a companion diagnostic. Our assays worked spectacularly well, and by far the best. Our assays are routine, low-cost, and easy to use. So I think we have tremendous advantages over any options. But the trials would have to be different from the other ones for sepsis and COVID, as that would be the diagnostic ones. But I think we would look to conduct proof-of-concept studies on several of those therapies at once. But I think the actual therapy trial would need to be a separate one, as it's a companion diagnostic to the therapy. Jake, did I get that right? Anything you would like to add?

I think you covered it well. The background is that the way that NETs behave is similar in all of these diseases. So you could, in principle, have a diagnostic for NETs. Initially, we are looking at separate diseases; all of that is going very well, and probably, as Cameron mentioned, in the beginning, we will focus more on sepsis, but there’s enormous potential across all.

It's important to reiterate that it has taken some time. We were hoping for some data late last year. But as we've mentioned a few times, it's very understandable that some of these longitudinal studies have been tough during the emergency periods when hospitals were overwhelmed. Taking multiple samples from one patient is not their top priority, understandably. However, I cannot stress enough how happy we are with the results and how our collaborators are recognizing the quality of the data, as well as how our assay has performed. The hard work we've done has led us to a point where we can ship kits to various places for testing, and they are working tremendously well. Our assays are performing as they should and are robust, reproducible, and reliable. We're in a solid position and will have a lot more updates on this throughout the next month or two and through the quarters. I believe this will be a significant part of our strategy going forward, as NETs are, while they have only recently been understood, they have the potential to be pivotal for diagnosis, prognosis, and disease progression.

That was great. Thanks so much, Cameron. That was a comprehensive answer there. And I just wanted to switch to the breast cancer screening products. On the beta launch in Asia and Europe, it is really encouraging to hear you guys are making progress. Honestly, what's the general plan regarding marketing and distribution? Do you already have relationships with some sites in Asia and Europe, maybe similar to what you have in the U.S. with Texas A&M? And then again, another difficult question to answer at this time, but when might the launch occur? Is that more of a 2022 event, or could that possibly happen in the back end of this year? Thank you.

That's a very good question. We've actually developed a strong footprint in Europe and Asia. We are very hopeful that the launch will occur this year and it could be reasonably soon because we are doing a lot of work on this. We can apply lessons learned from the U.S. Certainly, in terms of logistics and market learnings from Texas. We're actively discussing partnerships to restart our efforts in Singapore, which is a great market for learning. In Europe, we are also very active; the lab we have in Belgium is becoming similar to the GI lab in Texas. We're in a great position to perform testing directly from Belgium, so we are focused on running tests in that facility. We'd like to have it operating in the medium-term, ideally by the end of this year. The beta launch has also attracted the attention of significant companies, and we're having active discussions with two major players. If we can finalize a collaboration, it would greatly accelerate launches and sales worldwide. It's fair to say that I would be upset if we didn't see progress with launches this year. I'd feel confident about at least one of them happening soon, if not both. The market opportunity we're uncovering is significant and the beta testing has been invaluable for us. You'll see progress in the coming months.

Yes, I think that was great. Thanks a lot, Cameron. Just one last question for me. Similar line of thought perhaps on the expansion in the U.S. with the vet test. How are you evaluating the markets you want to expand into? What has been the feedback on your marketing efforts thus far?

Yes, absolutely. We're looking at key lessons learned from our beta testing to ensure we get everything right before a national launch. While it may sound boring, logistics are crucial, and we're testing some optimizations to reduce shipping times. The optimal marketing mix will depend on whether we conclude partnerships with major players. If we do, those parties will likely lead into public awareness and marketing efforts, which could change our market strategy significantly. We want a profitable approach that maximizes awareness, and our next quarter should yield more clarity on this. Overall, we'll continue learning from our experiences in the beta launch phase which has given us a wealth of insights.

Next question is from Jason McCarthy with Maxim Group. Please proceed with your question.

Just on the size of those Texas A&M orders. You mentioned three additional in 2021. Were those based on demand or are they expected as they build up their supply for the launch?

It is completely based on demand. From the accounts, I believe it was a little over $7,000 for about 160 tests, as they don’t use every kit since they have to run some repeats in humans. They keep reordering as they reach the end of the previous batch. This is all about revenue but also about learning from the beta launch as well. We've been fortunate to have real paying customers providing us feedback. The actual tests are working perfectly, and we've been adjusting our marketing approach. We had high anticipation for this launch, and it reinforces the interest from potential collaborations. Currently, there’s a lack of competition in this space, and we position ourselves strongly in the market outlook. We will have updates as we continue to build on this engagement.

I also wanted to ask about NETosis, specifically outside of COVID-19. It’s tough to predict pandemic trends. What about the opportunities with NETosis in sepsis or any other diseases?

I'll let Jake speak more technically here. From my perspective though, the opportunity is massive—potentially larger than cancer itself. Sepsis is the biggest killer in hospitals. We are collaborating with various groups to explore therapies and research. The increasing awareness from COVID has created avenues for broader research into NETosis. It's clear that with our assays for monitoring and diagnostic purposes, we can play a significantly beneficial role in identifying and treating diseases linked to NETosis. We're optimistic about the vast potential ahead.

NETs are a huge area of interest; it’s not just COVID. Many clinicians are now recognizing NETs due to their role in various diseases and conditions. The spotlight that COVID put on NETs has amplified their relevance in sepsis and many other diseases. The discussions I'm having underscore this increased interest across the hospital networks regarding NETs and their implications.

Thank you, Jake.

I really appreciate the thorough answers. One more question if you don’t mind. Regarding the proof-of-concept study and DLBCL, could you compare the trial design to the larger regulatory study? Can you utilize this as a read-through for potential filings for blood cancers?

That's actually a question for Jason Terrell, our expert on this. If I can have him call in for a follow-up after? He's put in a lot of effort into studying all types of NHL. I think it would be best to defer that question to him for the most accurate insight.

No problem; I think it's better for Jason to answer that.

Okay, alright. Jason has the organized oversight of these trials, and we'll have him clarify that in our follow-up.

Hey, good morning. Thanks for taking my questions. Regarding the veterinary market and beta launch going on for Nu.Q Vet, could you dive deeper into feedback from veterinarians and any revenue opportunities you’re observing?

Absolutely. We've been learning from the veterinarians’ feedback on logistics. Smaller fasting options are beneficial, and we're considering better packaging options. The fact there's nothing else like our product has helped us spark interest. The pivotal market for us might actually be including the cancer test as part of wellness tests for dogs, which many veterinarians conduct annually. There's also been interest in treatment monitoring for existing cases, and that could be a big area for us moving forward. We're reviewing pricing strategies and adjusting them based on feedback we're receiving. Our ultimate goal is to build a strong revenue stream from millions of tests sold while ensuring widespread adoption. This feedback is invaluable for us. Overall, we’re actively looking forward to enhancing our market presence with both our products and how vet professionals respond to them.

And gentlemen, I wanted to turn it over to Scott to hear any closing remarks. Go ahead, Scott.

Hi, guys. Just regarding Michael's question earlier. I've heard back from Jason Terrell about the blood cancer study. So, regarding the VC, DC, or PLC study, there is a treatment response monitoring test whereas the larger 1,500 study is an aid to diagnosing the disease. So, the readouts are not related. We also hope to have the treatment response data in the coming months, as the study has almost been completed. Hope that answers your question.

Thanks, everyone. There's a lot going on for us, and it's been an intriguing year as we adapted to challenges. From our fundraising efforts to product developments and teamwork, everything has worked out remarkably well. The upcoming quarters look promising as we continue to increase revenue through multiple streams while remaining rooted in exciting research and development, focusing on epigenetics. Thank you for your time.

Thank you, and this will conclude today's conference. You may disconnect your lines at this time, and we thank you for your participation.