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spk02: Good morning, ladies and gentlemen. Thank you for standing by. Welcome to Volition RX Limited's full year 2022 earnings conference call. During today's presentation, all parties will be in listen-only mode. Following the presentation, the conference call will be open for questions. If you have a question, please press the star key followed by the number one on your touchtone phone. If you would like to withdraw your question, press the star key followed by the number two. If you're using speaker equipment, please lift the handset before making your selections. This conference is being recorded today, March 16th, 2023. I'd now like to turn the conference call over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.
spk08: 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 full year 2022, 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 Group Chief Executive Officer, Mr. Terry Cuse, Group Chief Financial Officer, and Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary Subsidiary. 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'd now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?
spk10: Thanks, Scott, and thank you everyone for joining Volition's full year 2022 earnings call today. We especially appreciate your time given the busy earnings call season. 2022 was a transformational year for Volition. After 12 years in operation, we have successfully transitioned from a company solely focused on research and development to an organization that has also commercial products. Volition is powered by New Cube, our cutting-edge nucleosomics platform which has enabled the development of all of our product pillars and is the foundation of the company. I am so proud of the hard work, expertise, and commitment of our team and what we've achieved together. Given this is our full fiscal year result, we will commence the fall with our Group Chief Financial Officer, Terry Hughes, for moving on to Dr. Tom Butera, Chief Executive Officer of VolitionVac. for an update on the rollout of NICU VET via our global supply and licensing agreements. And finally, I will provide an update on the great progress the team have been making with regards to another one of our key pillars, NICU NET, as well as a brief update on NICU Cancer and NICU Capture. Without further ado, I'll hand you across to Tarek for the financial report.
spk09: Tarek? Thanks very much, Cameron, and thank you everyone for joining our earnings call today. I'll now provide a summary of the key financial results for the year ended December 31, 2022. Starting with cash, we closed out the year with cash and cash equivalents of approximately $10.9 million. From a revenue perspective, we recorded just over $300,000 in earned revenue in 2022, a 240% increase over the prior year. the majority of which was from sales of the NewQ Vet Cancer Test, with the balance mainly attributable to the NewQ Discover program. The net loss during 2022 was $30.6 million versus a $27 million loss for the prior year. This result was predominantly driven by higher personnel costs and sales and marketing spending as we prepared for commercialization. During 2022, we strengthened our balance sheet by adding approximately $6.4 million in net cash before deducting offering expenses through an underwritten public offering of our common stock in August. Furthermore, in August 2022, we were delighted to announce the award of approximately $1.5 million in non-diluted funding from the Moor & Best Capital Risk in Belgium. that fund the early access programme for our NewQ product portfolio at key sites across the EU, the UK and the US. Additionally, we recorded grant income of $1.2 million in 2022 from the Walloon region in Belgium. We continue to manage our expenditures and cash flow carefully, and whilst the overall level of expenditure increased in 2022 as compared to 2021, The impact on cash flow was more than offset by receipt of the HESCA milestone payment of $10 million in March 2022. As a result, net cash used in operating activities was $15.3 million for the four years, or a monthly average of approximately $1.3 million. In the most recent quarter ended December 31st, cash used in operating activities averaged approximately $1.7 million per month. While we expect expenditures to increase again in 2023, partly driven by our clinical trial activities, we also expect cash flow impact to be moderated by potential milestone payments of up to $13 million anticipated from the Hesker Corporation. So to recap, we closed the year with cash and cash equivalents of approximately $10.9 million. Subsequent to year end, we received approximately $8 million in net cash before deducting offering expenses through an underwritten public offering of our common stock in February. And we expect, upon achievement of near-term milestones, to receive a further $13 million this year from Hesker Corporation. We are now in revenue generating mode with a new cube vet cancer test available through the reference lab networks of IDEXX Laboratories, HESCA, the Texas A&M GI Lab, and some local distributors such as DNA Tech in Portugal. HESCA has also started pre-selling the new QVEC cancer test at the point of care, which we expect to provide a significant future revenue stream at a solid margin. It is great to see we are now up and running on our commercial journey, and I look forward to sharing revenue updates at our next earnings call for the first quarter in May. Given the range of products that we expect to develop from our proprietary Nucleosomics platform, we believe that our addressable markets are significant and we look forward to accessing these opportunities and reporting in due course. So we have made strong progress on many fronts in 2022 and into the first quarter of 2023. And with that, I will hand over to Tom for further detailed updates on the rollout of our Nucleobet cancer test and upcoming milestones. Tom?
spk07: Thanks very much, Tarek, and good morning, everybody. 2022 is a breakthrough year, and I feel really proud of all the team's achievements. It seems just a while ago now, but looking back to the first quarter of 2022, we signed our first large-scale licensing and supply agreement with the HESCA Corporation. The HESCA agreement provides three specific areas that you should all be aware of. First of all, exclusive rights to HESCA to sell Volition's NUQ vet cancer test for companion animals at the point of care. Number two, non-exclusive rights to HESCA to sell the NUQ vet cancer test for companion animals via HESCA's reference laboratories. And three, certain rights of negotiation to HESCA to potentially commercialize a wider test menu for companion animals, again, at the point of care. The HESCA agreement also came with some very significant financial milestones. To give you the breakdown, first of all, Volition received a $10 million upfront payment on signing the agreement, and Volition will receive up to $18 million based upon the achievement of near and midterm milestones, $13 million of which we anticipate receiving in the first half of 2023. In addition to these milestone payments, and most likely significantly greater than these payments, is the ongoing revenue that Volition expects to receive in relation to payment for kits for the reference lab market and for the supply of key components for the exclusive point-of-care product that Heska will bring to the market. You must all remember, every time Heska sells a test, Volition will make money. be that through the sale of a kit or from the sale of a key component. It's a long-term deal, and we believe that it's a fantastic market opportunity for us. And to bring folks right up to date in 2023, HESCA is now taking pre-orders for the HESCA NUQ Canine Cancer Screen and Monitor Test at the point of care, and we anticipate a full commercial launch in the second quarter of 2023. During 2022, we also executed a supply and distribution agreement with IDEXX Laboratories, a global leader in pet healthcare innovation. This agreement was signed in October and provides IDEXX with the rights to sell the new QVET cancer test worldwide through its global reference laboratory network. Pursuant to the IDEXX agreement, Volition expects to receive ongoing revenue from the sales of its reference laboratory kits. IDEX launched our test at the world's largest veterinary conference, VMX, which was held in Orlando in the U.S. earlier this year and plans to continue to roll out to other countries throughout 2023. I am delighted that the new QVET cancer test is now available in the mainstream mass market in the U.S., And indeed, happy to report to all of you, it's already been ordered by veterinarians in more than 40 states. Remember this important point. There are approximately 84 million pet dogs in the United States alone. Nearly 50%, 50% of U.S. households bring their dog to the veterinarian annually for a health exam. We believe that this provides a significant opportunity for us to introduce the new QVET cancer test as an accessible and affordable screen for senior dogs and at-risk breeds to aid early detection and improve outcomes. Simply great news for the veterinarians, their pet families, their pets, and a great reason to come to work every day. I'm also happy to report that Professor Wilson-Robles, and team continue to make great progress in both ongoing and completed studies. Of particular note is the use of the new QVET cancer test for monitoring disease progression and remission. And to that end, Professor Wilson-Robles recently submitted a paper for peer review about evaluating treatment efficacy in real time, accurately monitoring the progression of lymphoma and identifying relapse soon. all of which will provide veterinarians terrific information to help guide their treatment decisions. It's a terrific paper and demonstrates another potential significant utility of our test. In wrapping up and looking ahead, I'd say the next thing to look out for will be the full commercial launch of the HESCA NU-Q canine screen and monitor test at the point of care, which we anticipate in the coming weeks. We are also looking to expand our global distribution further and are pursuing commercial deals at a global, regional, and local level. So keep an eye out for that. And lastly, from an R&D perspective, we are working on our feline product and also looking to extend into emergency medicine, mirroring the human side of volition with an emphasis on notosis. So we have lots to keep us busy. And I look forward to providing further updates at our next update call and indeed at our capital markets day in May. And with that, I'll pass back to Cameron Reynolds, our group CEO. Cameron?
spk10: Thanks, Tom. And thank you, Tarek, for those comprehensive updates. Great progress indeed. From a commercial perspective, I would have to say signing the licensing supply agreement with Tesco and IDEX were standout moments of 2022 for me. But in the background, we have not only continued to strengthen our broad IP portfolio, which is a real asset for the company, but we've also dedicated considerable time and resources to scaling up and strengthening our infrastructure for delivering high quality services under our licensing and supply agreements. During 2022 in particular, we sought to build out our HR, IT, finance, legal and commercial functions to support the growing needs of the company. We now have over 100 staff worldwide, based in Belgium, the UK, the US, and Singapore, all of whom play a part in our future success. I will wrap up the call today with updates on several of our other product pillars, NUQ Capture, NUQ Cancer, and NUQ Nets. Human blood is a mixture of many different cell types, floating in a complex soup of proteins and other molecules, including nucleosomes released by cells from all around the body. Detecting a handful of cancerous or other abnormal cells in a patient's blood sample has historically been like finding a proverbial needle in a haystack. Volition's NUQ capture program has several strands of technology which, one, essentially remove background noise, thereby amplifying the signal, or two, look to identify the signal in a novel way, including through mass micrometry, or three, isolate various chromatin fragments, including nucleosomes and transcription factors, for further analysis by the mass spectrometry and or next generation DNA sequencing. I am very happy to report we have made real progress on a number of these strands throughout 2022 and into 2023. As a reminder, this sample enrichment tool removes healthy nucleosomes, leaving an enriched sample of abnormal nucleosomes behind for further analysis. One area of progress is linked to NUQ capture mass spec whereby we enrich the sample and then use mass spec to help identify specific cancer-related biomarkers. In 2022, we published a paper using this technology in colorectal cancer, and we have recently submitted for peer review a second paper, this time in relation to non-Hodgkin's lymphoma. These nucleosomes contain tumor-specific DNA, typos, epigenetic changes, and other biomarkers when analysed could potentially be used to diagnose a specific type of cancer or other medical condition, guide treatment selection, and monitor disease and treatment progress. Further, the use of mucocapture technology in the field of transcription factors has led to the successful isolation of tumor-derived transcription factor DNA complexes from blood samples obtained from cancer patients. As transcription factor binding to DNA is cancer and tissue specific, This technology may, in principle, provide the basis for blood tests for cancer in general, as well as blood tests to identify the organ or tissue affected by cancer. Development is ongoing, and I look forward to providing updates in future calls. In our new Q Cancer Pillar, we announced Volition's participation in a government-backed prospective study to evaluate the performance of blood biomarkers in the early detection of lung cancer with hospices Sybil de Leon HCL, France's second largest university hospital. The EMA's initiative for the initiation of lung cancer screening, EAD, is a wide-ranging clinical study assessing the feasibility of a lung cancer screening program and the effectiveness of screening. The EAD study will evaluate the performance of Volition's UQ test as a blood biomarker for the early detection of lung cancer when used alone and in conjunction with CT scans. with the ultimate goal of developing a national screening program in France. A longer-term project, but fantastic to be involved in such an initiative. Polition has also conducted a retrospective proof-of-concept study with HDL in lung cancer, the results of which will be presented at an upcoming conference. And lastly, we completed the National Taiwan University Lung Study. Analysis is underway, with publication expected thereafter. And so, to our final pillar covered today, NUQ-NETS. In May 2022, the NUQ-NETS product will see marks for the detection and evaluation of diseases associated with mitosis on two platforms, the ELISA plate and the automated i10, enabling clinical use in more than 27 countries across Europe. We firmly believe NUQ-NETS will have wide applicability for diseases with a NETS component, such as sepsis, COVID-19, influenza, thrombosis, et cetera, and potentially could enable the stratification of patients with a high level of NETs, allowing physicians to rapidly triage these patients and monitor their disease progression and response to treatment. In 2022, together with our collaborators, we published a peer-reviewed paper and two posters. The key finding reported is that levels of mucus mitosis, as measured by evolution of mucus NETs, are highly elevated in sepsis, and moreover, that the results correlate very well with the severity of disease, SOFA score, sequential organ failure assessment. This result has garnered a lot of interest from KUL and has led to establishing some of our centers of excellence. In August of 2022, Volition appointed DOCRO, a contract research organization specializing in the commercialization of diagnostic biomarker technology to spearhead our clinical product development and FDA regulatory programs in the U.S. DOCRO is undertaking large-scale finding studies across multiple sites using Volition's NUQ platform to determine clinical utility in sepsis and cancer with the goal that one or more of such studies will support an application to the FDA's Breakthrough Device Program. The first phase of the study focused on sepsis has been completed, and the application to the FDA's Breakthrough Device Program is expected to be submitted in the first half of this year. In drawing this call to a close, I'd like to thank you for joining the call today. We really appreciate it. I, along with the rest of the board, and indeed the whole company, I very much look forward to sharing further news regarding our new few product pillars, as well as the results of our key clinical studies, publications, and milestones over the coming months and quarters. And to that end, I'm delighted to say we'll be hosting a Capital Markets Day at the New York Stock Exchange on the afternoon of Thursday, May 11th. We would love to see you there. But for today, I'll wrap up saying I very much feel we are in an extremely strong position to commercialize our NUQ platform in so many areas. Volition is truly powered by NUQ. I could not be more positive about our work at the heart of epigenetics, and I'm very excited for the next phase of our journey. We're happy to take your questions.
spk02: Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question today, please press star one from your telephone keypad and a confirmation tone to indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants who are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Thank you, and our first question comes from the line of Bruce Jackson with Benchmark. Please proceed with your question.
spk12: Hi, good morning, and thanks for taking my questions. A two-part question here on the milestone payment mechanics. So do you plan to receive the full $13.5 million as a lump sum payment? And then does that get accounted for as deferred revenue? And then does it come back into the income statement over time?
spk10: I'll pass it over to Terry to answer the question. Hi, Bruce. Terry?
spk09: Hi, Bruce. At this point, we are expecting to receive the next $13 million. We're expecting it's actually two separate milestones of $6.5 million each. And the first one is on the commercial launch of the point-of-care product as a screening test. And the second one is for the first commercial sale as a monitoring test. We are expecting to get both of those within the first half of this year. In terms of the accounting for that, it will initially be treated as a deferred revenue under the accounting rules and will be allocated along with the 10 million milestone payment that we received last year. over the life of the product. So as we make sales, a portion of the deferred revenue will be allocated to each product sale that we make.
spk12: Okay, great. And then just one follow-up, if I may. With the remaining $4.5 million, is that going to come to you in 2024?
spk09: So the remaining $5 million will come to us in 2024, subject to us providing data or the first commercial sale of a cat product. So we are expecting that in 2024. Can't tell you exactly when, but it's on track.
spk12: Okay, super. Thank you very much for taking my questions.
spk10: Thanks. Have a great day.
spk02: The next question is from the line of Constantine Davides with EF Hutton. Please proceed with your questions.
spk06: Hi, good morning. Just sounds like really good progress, early progress in the commercial front. And I guess just following up on Tom's comments about receiving orders in 40 states, I was wondering couple things about that. One is what's the profile of some of these early adopters in terms of their practice, just whatever characteristics you can share, and then any kind of early lessons, both positive and negative, in terms of how you're talking to these customers and any tweaks you might have in terms of messaging or promoting the product. Just looking for some color there. Thanks.
spk07: Hi, Constantine. Tom, thanks for the question. You know, our awareness campaign and education of the veterinarians has been very specific. It's supposed to be used for wellness preventive care programs, of which close to 50% of the dogs that are presented to the U.S. on an annual basis come in for wellness exams. So these are healthy animals, and it's not supposed to be used for sick animals at this point in time. Of course, it's also supposed to be predominantly used for dogs 7 years of age and older, because 50% of dogs that approach the ages of 9, 10 years of age die of cancer. The other strong target is about 30 predisposed breeds starting at the age of four years of age. So that's how we have positioned the test. We are gaining data as we are testing animals in a large number of diversified practices. They're predominantly general practices right now because it is a wellness preventive profile. And consequently, those are the hospitals that are using it and using it pretty effectively. As far as giving you a more broad spectrum piece of information, specific hospitals, obviously, I can't do that. But the feedback that we've gotten from a general basis is, and the questions that are given to us on Ask NewQ, which is our hotline, predominantly come from general practitioners using it in their wellness profiles.
spk06: Great. Thank you. And then just one follow-up. I know you spent some time going over milestones, and you did an offering in February, and you've alluded to clinical trial expenses kind of ramping up this year. Just wondering if you can give us any kind of sense for where we should expect burn to fall this year, particularly as you invest in some of these clinical programs.
spk09: Yeah sure, it's a good question and we do expect that the burn will ramp up a little bit this year because of the clinical trial costs and clinical trial activities that we're undertaking. Right now we're probably looking at something in the region of 2 to 2.5 million per month in this quarter but that will be offset over the course of the year with the milestone payments that we receive. So although we expect the overall expenditures to go up, we expect that to be mitigated by the $13 million of milestone payments that we will receive in the first half of the year. Does that answer your question?
spk06: It does. Thanks. I'll hop back in the queue.
spk02: Great. Thank you, Cassidy.
spk10: Thank you. Take care.
spk02: Thank you. Our next question is from the line of Stephen Ralston with SACS. Please proceed with your question.
spk05: Good morning or afternoon. I'd like to focus on the near-term revenue potential for the canine detection test. First of all, concerning the deferred revenues, When you say that it's going to be allocated over the life of the product, in that lifetime, are you assuming that it will be that $1.5 billion opportunity and that you'll achieve that and it'll be a percentage of that? Or is there something like a shorter time frame, like the expected sales over the next, let's say, five years or three years?
spk09: So the contract that we have that the deferred revenues relate to spreads over approximately 20 years. The way that the accounting rules apply is that we forecast the revenue over the life of the product, and then we keep updating those forecasts and allocating the revenue accordingly. It is a bit of a complicated process and a bit of a moving target because as we get better at forecasting the revenues, the amounts that we allocate per product sale will change over the years. It's a bit of an unknown quantity at the moment, but I think the best way to think about it is this will be allocated over quite a long time. It's not going to be over four or five years. It's going to be over something like closer to 20 years.
spk05: All right. Thank you. Actually, that's a good news, bad news situation because the greater the potential of the product, the smaller the allocation. So in a way, you're hoping that you won't be able to quickly monetize those revenues in sales, because that means the product would have more potential than you expected.
spk09: That's right, Stephen. I think the important thing for us is that we get the cash when we get it, and we're able to spend that cash and utilize it. And from a discounted cash flow point of view, it's the cash that's important rather than the accounting rules.
spk05: And as deferred revenues, when you talk about your cash balance, does that include the deferred revenues?
spk09: Yes, that does. The cash balance includes the $10 million that we already received in March last year.
spk05: All right. And the paper that was submitted for peer review, I assume that's the use of the test for monitoring? Yes.
spk07: That's correct, Stephen. It was submitted about a month or two ago, and it's for monitoring for disease progression and remission, and we're currently getting some questions back. It looks very favorable, and we hope to have that publication approved hopefully within the next month or two.
spk05: All right, and that's the reason for your target that you expect it in the coming weeks, and that would trigger one of the $6.5 million payments, correct? That's correct. Absolutely. And looking into the future, what do you expect the timeline for the feline component of the test? When do you think that that will start generating sales or being commercialized? Is that a 2004 event?
spk07: Yeah, 2024 is when that would probably start. We're going through validation studies right now. We're working through all of that. You know, there's almost 100 million cats in the United States alone. We're just talking about canines right now. So, obviously, if we are effective in bringing this to market, this could be a significant opportunity for us. We anticipate hopefully completing our studies on this, hopefully by the end of 2023 and early part of 2024, and having a paper validating our studies, hopefully by the first half of 2024.
spk05: And I'm assuming that the next commercialization revenue stream is going to be from NucuVets. Is that what you're...
spk11: Sorry, is that within new cuvette, this will be the next one, or the next revenue for the entire company would be this?
spk05: Yes, the next commercialization revenue stream, with the initial one being new cuvette, obviously for different animals, and you say companion animals, and I assume that even goes into equines. Then the next grouping would be new cuvettes,
spk11: That's correct. So we've got the two-pronged strategy, the U.S., which we're in the process, and I think we're reasonably close to applying for breakthrough designation status. We would expect if we do get breakthrough designation status, it's very nice, and we'd be ready to commercially launch by the end of 2025 in the U.S., If we do not get breakthrough designation status, we're hopeful, but you never know, it would delay it sometime into 2026. But don't forget, we do have a CE mark on two platforms in Europe now. We've got a lot of key opinion leaders now working on validating the product in their own areas. We would expect potentially some early revenue, smaller revenue later this year on clinical revenue or milestone revenue in UQ nets. from Europe or a deal, but nothing really substantial until next year in Europe. And then, as I said, 25 if we get breakthrough designation status or 26 if we do not. And I think it is going to follow the commercialization path.
spk04: of UQ Vet, low capex, low opex, deals with big companies.
spk11: We're in very active discussions with a wide range of companies now on adapting UQ Nets to their platforms, a handful of multi-billion dollar companies or larger. So the UQ Nets is really taking off on the commercialization side, and that should become a big part of the story later this year and next year. Thank you for taking my questions.
spk08: Thank you, Stephen. Thank you, Stephen.
spk02: Our next question is from the line of David Westenberg with Piper Sandler. Please proceed with your question.
spk03: Hi. Thank you for taking my question. Sorry if I missed this. I'm newer to the Volition story. So on the point of care veterinary NUQ test, can you remind us again the expected commercialization date on the point of care and what part of it is in your court versus what parts of it are in HESCA's court? In terms of the commercialization.
spk07: Yeah, thank you David for the question. It currently is under the end stages of validation in Texas court at this point in time. So we are waiting for that and we're getting closer every day. We're very excited about it at this point in time.
spk03: Gotcha. And then, you know, I really like the way it's positioned on the IDEC side as, you know, this is one of a series of ancillary tests to be used in a wellness setting. Can you talk about some of the ancillary tests that people use in conjunction with NUQ? And can you talk about, is there any opportunity for you to commercialize some of these ancillary tests, maybe in a point of care or any kind of ways to think about that?
spk07: Yeah, another good question, David. Typically with dogs that are seven years of age and older, and this is supported a lot by the AVMA and the veterinary community, they typically come in once or twice a year for what we call a routine chemistry panel. And in that routine chemistry panel, typically CBC and routine chemistries are done. BUN, creatinine, liver enzymes, this type of thing. That profile typically will cost a veterinarian excluding the exam, excuse me, a client, somewhere around a couple hundred dollars. If potentially an x-ray is done, it might be a little bit more than that. And if you think about it from that standpoint, including our very affordable test into that price structure as part of a cancer screening test, it just fits right in the middle of it. especially for those dogs that are seven years of older, because the veterinarian, when they communicate to the client, is not going to say, oh, yes, we have this other cancer screening test that's extremely expensive. No, it's highly affordable, can be delivered by the veterinary technician as well as the doctor. The same scenario, David, also applies to the dogs that are four years of age and older. It's recommendations from the veterinary community right now that you start profiling animals at the age of sometimes three and four years of age, so you can watch for medical trends. Again, the profile may not be as extensive as it is for the seven-year-old, but certainly we encourage veterinarians and many veterinarian hospitals to do that. Again, the NucuVet cancer test can fit right into that, especially with reference to those predisposed breeds. And quite frankly, if you have a golden retriever or a Labrador or one of those types of dogs, You're going, once you start doing it, you're going to do it more than once a year. You're probably going to do it biannually because you really want to know, can I catch this before I start seeing clinical symptoms? So hopefully that answers your question.
spk03: Yes, that definitely answered the question. Just on my last one here, can you talk about the feline product? Is that in the agreements that you have, the commercialization partnerships with either Huska or IDEX, would that be – separate and you know if it is separate what would be your commercialization strategy with that and thank you very much for the questions
spk07: Yeah, David, on that, specifically with reference to feline lymphoma, and that is with HESCA, and specifically as a point of care. HESCA has an exclusive with us on a point of care with that product. We're not only going to be studying feline lymphoma, which is the predominant one in cats that veterinarians frequently are having to deal with, but we're also looking for other additional cancers as well. So feline lymphoma is the specific one that comes up most prevalent. That's the one that we're booked in with in terms of the point of care test exclusivity with Hesco.
spk11: David, just to clarify one thing as well, just our business model, you asked, I think specifically, would we add other things to our panel? Obviously, the partners we license to and sell the basic products to, exactly what Tom said, but we do not see ourselves running our own lab, having our own sales force, or even our own machines. So we will absolutely be used with other tests, but Volition's focus is to produce the key components and then prove the product works and then let others do the selling, the panels, the collecting of the blood. That's in human and in animals. So that keeps our model very low capex, low opex from our side. So typically that will happen a lot, but it's not something we will do in that process. And that is the model we'll take through the human mitosis and human cancer space as we grow so that we can grow very quickly and do all the heavy lifting is done by our partners on the commercialization side, if that makes sense as well. It does. Thank you.
spk02: Thank you.
spk04: Thank you, David.
spk02: Our next question is from the line of Jim Sidoti, the Sidoti Company. Please proceed with your question.
spk00: Hi, good morning, and thanks again for taking the questions. First one is, you've made a lot of progress so far. You've signed up two very large distributors in the vet world, but there's still a third one out there that I think Tom knows very well. Are you in discussions, and is it possible we'll hear something about that in the next 12 to 18 months? We are. It's a very good question.
spk07: We are in active discussions with a number of big partners that are out there. And we are in continued active discussions, and they are active at the present time.
spk00: And then as far as capacity goes, do you have to make any investments to ramp up production to supply these key components, or do you have the capacity on hand already for that?
spk11: A very good question. So we can produce the key components. Obviously, the two biggest ones are the antibodies and controls. We mass manufacture the controls now in Belgium at our Silver One facility, which has worked out fantastically well. We are doing some minor expansions in the freeze drying and some other areas, but we tend to get that actually as a support from the Belgian region.
spk00: But you're talking the hundreds of thousands of dollars. It's nothing ever going to be very large.
spk11: On far as production of the plates, we use a group in the US now for our US needs. I actually visited them last month, and they're very capable of ramping up at a very high level. So that should not be a problem unless it really, really got very big very quickly. But we do expect the growth to be steady over this year and through next year, so it should not be a problem. And we are also ramping up some internal capacity in Belgium for any extra capacity on the plates. But overall, we think we're very comfortable we have the capacity to meet any likely demand, but we are preparing for the future to make sure that as that demand grows, which we do expect it to strongly grow throughout this year and through the next years, we can meet it.
spk02: All right. Thank you. Thank you. Our next question is from the line of Ian Castle with IFCM. Please proceed with your questions.
spk01: Yeah, I guess my question would be directed towards Tom. You know, the vet opportunity seems really, really enormous when you think about just the cancer screening now launching in the U.S. and then globally, cancer monitoring. It sounds like that should be launching later this year. Same thing is launching for cats then into 2024. And you mentioned natosis for vet. And, you know, I don't know if that's a 2024 or 2025 type of product, but I was wondering if if you could kind of explain, Tom, what that test really is and how it could be applied at the GP office.
spk07: Yeah, certainly. Thanks for the question, Ian. First of all, we are currently starting our studies in mitosis this year in 2023. We anticipate hopefully having some papers by 2024 and doing some presentations on it at the various conferences probably throughout the world. To speak a little bit about mitosis, you asked specifically about GP. There's two levels here. The first level, with reference to mitosis, it's a biomarker that uses our platform to be able to identify non-cancer diseases. in particular diseases such as sepsis, thrombosis, pancreatitis, aspiration pneumonia. These are all diseases that are very common on the human side as well, but they're also very common on the canine, on the animal side. So consequently, those are diseases that we have marked as studying first so that we can do proof of concept, that we can actually identify this biomarker as a differentiator in those diseases to give the veterinarian whether it is a GP or a specialty emergency doctor, a key idea as to how sick that animal may be in one of those disease entities that I just mentioned to you. So an animal that comes in that's sick, vomiting, diarrhea, septic, Not feeling well. Before you have to run a whole ton of chemistries, this could be the initial biomarker that that GP late in the afternoon takes on that animal to give an indication whether to go to emergency, whether to stay in the hospital, or maybe you can go home and come back again the next day for routine treatment. With reference to the specialty in emergency hospitals, this is something that's really going to be something very beneficial from a triage situation. These hospitals are over-inundated with animals coming in on emergency and then trying to triage which ones are going to get treated first and which are the most ill. This biomarker, the mitosis biomarker from us, potentially will be that differentiator, be the first test that we go to. to give us some indication as to where are we going to go with this animal, how sick is it, and what level of treatment does it need. The other part of it obviously is too, is once we have that initial marker, that mitosis biomarker will also be used as a monitoring tool for that illness with that animal in that emergency situation. So you can see it has multiple applications. It really is something that can be very cost effective and provide a tremendous amount of information.
spk11: And if I could also say, I think this is a very good example of how NUQ works across and crosses over between humans and animals. So obviously we developed notosis first in the human space, and I outlined that. And Tom now has done very well in outlining on the veterinary space how that works. And so we have a very symbiotic relationship between the vet and the human side, and it's really helped. And the vet side often helps the human side. For example, the platform, which we believe HESC is about to launch on, could also be very useful. It's the size of a toaster. And a very good platform could also help us in the human space. So I think the vet team and the natosis team and the rest of the Volition family are working extremely well together, and it's raising all votes The vet side helps the human, and the human helps the vet. And I think it's worked incredibly well keeping together as an organization and making sure we raise all boats.
spk01: Maybe the last question I have as well is there's an area of vet that hasn't been talked about yet that is very significant, and that's on the production animal side. Is there applicability to either the cancer screen test or the ptosis test, you know, kind of hitting that large market opportunity as well?
spk07: Yeah, I would say the answer to that, Ian, is mitosis in particular when we're looking at potentially an equine or potentially a bovine or a cattle situation. With reference to cattle, which is a multi-billion dollar industry, there's a lot of diseases with reference to mitritis. Or mastitis or respiratory disease, and that really falls into the ptosis type product where you can come in and diagnose and get a strong indication in a herd as to which ones of those animals are ill. So you don't have to treat the entire herd. I mean, you can imagine feedlot situations. I mean, it could be an immense product. On the equine side, we specifically, we certainly see it for use in disease entities, but the other area where we see it could really be a significant marker is from a performance standpoint to really give us a strong indication as to how well that horse is performing or where that horse may need some additional therapeutics. So those are the two areas that we're going to be looking into. Most likely, those types of studies will be really starting to ramp up a little bit, latter part of 2023 going into 2024. Okay.
spk02: Thank you.
spk07: Thank you, Randall. Thanks, Ian.
spk02: Thank you. At this time, we have the end of our question and answer session, and I'll hand the floor back to Cameron Reynolds for closing remarks.
spk11: Thank you. Before I start the closing remarks, I'll just make one statement. We've been asked a few times whether we had any exposure to Silicon Valley Bank and other market issues with the banks.
spk00: Short answer is no, we do not.
spk11: And we are obviously monitoring the situation, and like everyone, there's some fluctuations in markets and things going on, but we have no direct exposure to it whatsoever, just to be clear, in case anyone asks that in the future. And so, thank you very much for the call today. I think it's very clear we are now very much on the commercialization path. We are continuing on with our development and research, but we're really on the front foot now on the vet space and I think on the natosa space, and we are really following up now on the human cancer space as well.
spk00: So expect to see a lot more information throughout the year as the revenue goes up.
spk11: as the revenue goes up and really starts to show a steady ramp on what we are. And then as we really start to layer in the notosis and some more notosis deals and revenue, as well as the human cancer side, we'll have a lot more coming in on as well. So thank you very much. And as a final reminder, we have a capital markets day, which will be before the next queue, which is on May 11th. around May 11th in New York City. And yet again, we'd like to thank the New York Stock Exchange for letting us use their fantastic facilities. And we'll be making quite a few presentations and developments on all the things which are moving forward so well. So anyone who can make it, please contact us. And it should be yet another great occasion where we can showcase the progress we've made on so many fronts. Thank you very much. I'm really looking forward to updating you in the coming months as we continue to develop. Thank you for your time.
spk02: This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.
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