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spk12: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Volition RxLimited First Quarter 2024 Earnings Conference Call. During this presentation, all parties are in listen-only mode. Following the presentation, the conference call will be opened for questions. If you have a question, please press the star key followed by the number one on your touch-tone phone. If you would like to withdraw your question, Please press the star key followed by the number two. If you are using speaker equipment, please lift up the handset before making your selections. This conference call is being recorded today, May the 14th, 2024. I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer.
spk02: Please go ahead. Thank you.
spk05: and welcome everyone to today's earnings conference call for VolitionRx Ltd. 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 Harbour 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 may 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 , quarterly reports on Form 10 , 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. We will start the call today with Terry Cuse, our Group Chief Financial Officer, who will cover Volition's financial and operating results for the first quarter of 2024, along with a discussion of recent finance activities and a look ahead. Dr. Andrew Retter, our recently appointed Chief Medical Officer, will provide a commentary about our clinical trial programme, and then Gael Forte, our Chief Commercial Officer, will summarise some of the key commercial achievements this quarter with a look ahead to upcoming milestones. Lastly, Cameron Reynolds, our President and Group Chief Executive Officer, will provide a brief wrap-up before we open the conference call to a question and answer session. I'll now turn the call over to Tereg.
spk10: Thanks, Lou, and thank you everyone for joining Volition's first quarter 2024 earnings call today. We do appreciate your time given the busy earnings season. I'll now provide a summary of the key financial results for the quarter ended March 31st, 2024. We ended the quarter with cash or cash equivalents of approximately $11.8 million. Throughout this quarter, we have continued to work on a number of threads with the aim of ensuring Volition is cash flow neutral in 2025. We are making strong and necessary decisions to preserve capital in the company whilst ensuring we deliver on our vision and mission. Firstly, from a funding perspective, as you are probably aware, throughout the company's history, we have been successful in securing non-diluted funding on favorable terms. And year-to-date, we have targeted a range of government agencies, including in the U.S., to fund or co-fund some of our strategic projects up to $25 million. In addition, we have applied for or are in the process of applying for an additional $18 million from various European agencies. As a reminder, we have previously received over $20 million in non-diluted funding support from various Belgian and European agencies. We will provide further updates on this in the coming months. Secondly, as Andy and Gail will cover later, we are working hard to complete the materials for our data rooms during this second quarter for NUQ nets and CAPTCHA PCR to enable licensing negotiations to move forward. If successful, we believe that this strategy, like the approach we took with NUQVET, could provide us with ongoing royalties and very meaningful milestone payments in the next 12 months. thirdly now that we expect that we are very close to receiving large amounts of data for both new q nets and capture pcr subsequent to quarter end we took some necessary actions in order to significantly reduce expenditures and cash burn as we focus on commercialization we have and will continue to undertake a thorough review of all projects with the aim of streamlining our r d innovation scientific and sales and marketing activities to help ensure that we deliver on our focused action plans and monetize our exciting technologies and intellectual property. Our goal is to reduce expenditures by $10 million on an annualized basis. Additionally, to demonstrate their continued commitment and belief in the long-term potential of the company, the board of directors intends to take 50% of their fees in equity for a minimum of six months. And the leadership team intends to take a percentage of their salaries in equity for a minimum of six months, ranging from 10% to 50%, with our group chief executive officer, Cameron Reynolds, taking 50%. We have also postponed the payments of any cash bonuses indefinitely. We have invested significantly over recent years to build out our product pillars and to ensure we have robust scientific and clinical evidence to support our potential breakthrough technologies. Following our anticipated receipt by the end of June of a substantial amount of clinical data, we intend to have a laser focus on commercializing our potentially groundbreaking technologies. From a revenue perspective, this quarter we recorded revenue of approximately $170,000 for the quarter, approximately 15% higher than the same period last year. About 75% of the revenue was from NewQ Vet and the remainder from NewQ Discover. The initial phase of a product launch can take time as adjustments are made to the product workflow, marketing, price, etc. And so, whilst the revenue ramp from NewQ Vets has taken longer than anticipated, we do expect revenues to accelerate in the second half of 2024 due to two very important recent product launches. We are delighted that two additional large distributors have recently come online with our NewQ Vet Cancer Test. Antec Diagnostics, part of the Mars Pet Care Group, announced the launch of a new QVET test, not only in the U.S., but also in Europe, and have been very active in marketing of the in-house test at a very compelling list price of $35 to the vet. It was very heartening to see Antec's press release, including several excellent vet KOL endorsements in both the U.S. and Europe. And you might remember from our last call that the vet team were out in Japan supporting Fujifilm Vet Systems at their launch event at the World Veterinary Cancer Congress. Fuji is also pricing the test to vets at below $40 and will market our test aggressively later during the second quarter after very good initial feedback from vets. So we certainly hope to see revenue accelerate in the second half of the year. To sum up, our aim is to become cash flow neutral in 2025 by increasing revenues, cutting costs to reduce expenditures by 10 million on an annualized basis, getting very meaningful further government non-dilutive funding and licensing milestone payments from UQ nets and CAPTCHA PCR. As we have said on previous calls, our commercial strategy is to monetize our intellectual property through licensing. To that end, we are delighted with the progress we have made with NUQ VET and with the progress we are making with NUQ NETS, Capture PCR, and NUQ Lung Cancer. And to provide more details, I'd now like to hand the call over to Andy and Gael. Andy, over to you.
spk09: Thank you very much, Tarek, and good morning, everybody. Thank you for joining us today. I will start by reiterating my conclusions from our last call just a few weeks ago now. I believe that Volition's technologies will not only help with diagnostic enrichment, but also with monitoring a patient's disease progression and response to treatment. And most incredibly, we should be able to accomplish these goals with a relatively low cost, easily available routine blood test, which can be used widely around the world. We have certainly made excellent progress towards achieving these ambitions in the last year, starting first with new QNAPs and sepsis, I wanted to highlight a couple of studies which we hope will provide strong clinical utility evidence. We have ongoing analysis of two large-scale retrospective sepsis cohorts in Europe, the German sepsis group and work with a team at UMC Amsterdam. This will encompass over 2,500 patients with longitudinal samples. We hope to characterize cohorts of patients with sepsis And this should be a really rich and valuable source of insight into the value that H3.1 on UQNets offers. These samples have now all been run, and we're working on the complex process of data analysis. We aim to have this completed by the end of next month, but we'll have data ready to show soon afterwards. We extended the DOCRO study in the US to include sicker patients and for patients to be initiated from the emergency department rather than simply ITU. The plan is to close out this study in the coming months. In summary, across all the studies today, we'll have data covering patients from the emergency room presentation through to intensive care unit admission. We will cover key outcome measures with new QNETs correlated with the sepsis 3 diagnostic criteria, disease severity, specifically picking out risk of development of organ failure and types of organ failure, intensive care mortality, 28-day mortality, duration of organ supportive therapies, and length of stay in hospital and in ITU. We believe that this data will significantly strengthen the contents of our confidential data room to support our ongoing commercial discussions by the midpoint this year. Our project with key opinion leader Professor DiGiaglia now in France is also progressing well. This is a consortium project of an ongoing prospective study of which Volition is a key member. Again, it's longitudinal in nature and large scale with an anticipated recruitment of about 1,500 patients. Finally, the Epictetus study at my own hospital, Guy's and St Thomas' in London, is now underway with our first patient recruited in December last year. From a publication perspective, we're making solid progress. Following on from our key opinion leader event last year, I've been working closely with the clinicians on a clinical review article with our intention to submit it for peer review by the end of June and hopefully publication shortly thereafter. We received positive feedback from our publication by one of our colleagues, Kieran Zuckers. We have addressed the reviewer's questions and the paper has been resubmitted. We hope to hear back confirmation that it will be published very shortly. The findings of the synthetic sepsis model emphasize the importance of investigating mutual physiology and biology. This is relevant to enable us to have a better understanding of disease pathology, of risk factors and factors that trigger neutrophils and lead to an excessive immune response. Ultimately, this will lead to us identifying therapeutic targets to allow us to intervene and hopefully change the trajectory and improve outcomes of patients with sepsis. We have a robust scientific pathway strengthening our evidence as we continue to develop and supplement our clinical data to support our scientific rationale. We aim to publish more papers over the coming year. We anticipate a number of the clinical studies, as I mentioned earlier, will report out at the European Society of Intensive Care Meeting, a flagship event in Barcelona in October. We're also proudly sponsoring our first satellite symposium, and the session will be chaired by Professor Dijalianan at the Congress. We expect all of these activities to help us continue to build momentum and generate licensing interest. One final comment on UQNets before I move on to our cancer technologies. I would like to reiterate that the sense from the KOL group was that UQNets potentially represent one of the biggest breakthroughs in sepsis management in the last 30 years, potentially helping us to diagnose, monitor and treat patients more efficiently and hopefully save many lives. We have many more details to follow, but it certainly looks a very busy and exciting year ahead for new Gneps and sepsis. Cancer, as we all know, is a very serious and deadly disease, causing almost 10 million deaths in 2020. The incidence of cancer is forecast to increase as our population ages, with an estimate of around 30 million new cases diagnosed each year by 2040. Like many diseases, early diagnosis of cancer has a significant impact on outcome. Quite simply, the earlier we can diagnose the disease, the greater chance of survival and a better quality of life for our patients. Early diagnosis is, however, very challenging. Often, cancer develops silently with few symptoms, and often people are diagnosed only late in the illness when fewer and much more aggressive treatment options are available. Early stage cancer is difficult to detect because the cancer-derived circulating tumor DNA is low. It may compromise only 0.01% of the DNA present amongst a background of normal cell-free DNA. We're very excited as Volition has developed a novel method of liquid biopsy involving the first ever reported physical isolation of a class of tumor-derived ctDNA fragments from blood. These cancer-derived tumor DNA fragments are extracted, and after removal of the normal background DNA, the cancer DNA is detected and characterized with a low-cost PCR test. We're calling this new technique CapturePCR. Volition's proof-of-concept data was presented at the European Society of Medical Oncology Conference in 2023. We demonstrated the isolation of tumor-derived DNA fragments from plasma. Volition has tested the new method in a small clinical experiment and detected a range of solid and liquid tumors, including early stage 1 diseases. These early assays were developed using a leukemia model, but to our surprise, we were also able to detect many other cancers, including detecting colorectal cancer in a blood test with an accuracy approaching that of the current fecal immunochemical tests or FIT tests. Subsequent to our initial poster, Dr. Jake McAuliffe and team have presented at a number of cancer-specific conferences, sharing initial data and developing all-important key opinion leader and potential centres of excellence network. The team have continued to identify other potential biomarkers and the associated PCR tests, especially in solid cancers, to conduct initial clinical studies in larger, more diverse patient cohorts. From a publication perspective, again, we are making solid progress. Jake and the team are working very hard to complete their first manuscript and plan to submit this breakthrough method for peer review by the end of June. This will be an incredibly important paper to add to our data room and support our ongoing commercial discussions. It's surprising to say ESMO 2024 is just around the corner. And to that end, with our census of excellence, we have submitted several abstracts for consideration. I'm delighted to say these abstracts are not only CapturePCR related, but also include some significant and very promising new data related to the use of our new Q technology for lung cancer. Definitely something to keep an eye out for the third quarter of this year. I will conclude by saying that year to date, we have added supporting materials to our data rooms for new QNets, CapturePCR and new QCancer. Whilst not all of this data is published yet, we are able to share it in commercial discussions under non-disclosure agreements. With that, I'll hand you over to Gael. Thank you very much for listening, and thank you, Gael.
spk06: Thank you very much, Andy, and good morning, everyone. Before I discuss the data rooms and our ongoing commercial discussion, I would like to reflect on our progress so far licensing and commercializing our technology. In relation to the NUQ VET test, we have received $23 million so far, $10 million upon signing the exclusive agreement for the in-house diagnostic test with HESCA, no NTECH, which is part of the MARS PEDCA group. We then subsequently received $13 million upon the achievement of two milestones in December 2023. On an ongoing basis, under this agreement, we will also receive payments for the supply of the key component for the NUQ VET cancer test, on the Elementide Plus in-hospital platform. We have also executed a number of non-exclusive reference lab supply agreements for this test with global and regional veterinary diagnostic companies. This includes IDEXX Laboratories and most recently, Fujifilm Vet Systems. It is safe to say that we have made significant progress in making our tests accessible to veterinarians in a number of major markets in the U.S., Japan, and many European countries, not only through the reference lab network, but also now available in hospital at the point of care to give results to the veterinarian in less than 10 minutes. These countries are home to around 150 million pet dogs, so they represent a significant market opportunity. As Tom has mentioned on previous calls, cancer screening in the veterinary market is a new concept. And certainly, while there is significant interest, it is taking time to properly launch, educate, convert, and scale. Through the recent launches by Ntech and Fuji, not only have we seen significant engagement from their teams and the support of several KOLs, but notably, they are both offering the test at a very competitive list price of around $35 to $40 to the veterinarian, which is in line with our desire to keep the test as low cost and therefore as accessible as possible. We look forward to providing a more detailed update regarding this product line on the next call. But in the interest of time today, I would simply want to highlight the experience we have accumulated as a business that we might leverage as we move to commercializing some of our other technologies, such as, but not limited, to new QNETs and CAPTCHA PCR. As Andy discussed, we have been busy preparing our data rooms to support ongoing discussion and negotiations with interested parties. The nature of this potential licensing and our supply agreements is both broad and complex. As you can imagine, there are a range of options we're discussing, from exclusive, non-exclusive, global versus regional, specific clinical indication, or even the components part. We have had an incredible amount of interest in our technology so far and are making strong progress on a number of fronts. Key to some of the discussion is the data that Andy alluded to, much of which we expect by the end of the month, as well as some important publications following soon after. The continued development of the Key Opinion Leader Network to champion our technology is also very important, and we look forward to hosting our second Sepsis KOL workshop in the third quarter, and our first CAPTCHA PCR workshop in the coming months. We're on a very positive trajectory as we work to push our technology up the value curve in order to maximize the monetization of our IP through upfront medicine payments and ongoing licensing revenue. In the interest of time, I will pass to Cameron in a moment, but I just wanted to highlight that we also have a number of other programs that are generating commercial interest. And with the goal to accelerate our go-to-market, we might lessen them early, which may mean reduce upfronts, but will also reduce the expenses and for us, accelerate revenues. I look forward to providing further updates later in the year. And with that, I will now pass on to Cameron for a summary. Cameron.
spk11: Thanks, Gaël, and thanks too to Andy and Tarek for their comprehensive reports. In drawing to a close, before I highlight some key points, i would first like to take a moment to acknowledge the tireless dedication hard work and encouragement of our retiring executive chairman dr martin forks dill has been with us since the company's very inception 14 years ago but having recently celebrated his 80th birthday will now continue to support us as a long-term shareholder and mentor Thank you, Dil, for your counsel, and thanks also to the outgoing board member, Ed Butcher, for his many years of service. We are active in our search for a new chair, and indeed directors, as we seek to further strengthen the commercial acumen of our board. Our focus continues to be on getting each pillar to support itself, either through product revenues, milestone payments, outlicensing, or other non-dilutive funding in the coming year. as well as on the company wide cost reduction measures of a further 10 million outlined by Terry earlier. This is to ensure as little dilution as possible towards being cash flow neutral as early as possible and then drive on to profitability. We expect new cuvette revenue to increase in the second half of this year now that Antec and Fuji have launched the product and as existing partners expand into new territories. We're also focusing on the feline product development to secure the final milestone payment of $5 million from Heska Antec. We are also very actively targeting a range of government agencies and currently going through the process to secure further non-dilutive and or government project funding in the range of $25 million in the US and a further $18 million in Europe. Lastly, as discussed by Gael, there has been a lot of external interest in our NewQ Capture PCR and NewQ NETS technologies. We have made strong progress through the first half of 2024 in getting the data required, and our strategy is to monetize our IP through licensing agreements, as we did in VET. We expect a very large amount of data to be completed by the end of next month in the two key areas of NewQ NETS and Capture PCR. If successful, we believe this strategy could provide us with ongoing royalties and very meaningful milestone payments within the next 12 months. In drawing this earnings call to a close, I would like to thank you all for joining the call today. We very much appreciate it, given how much there is to digest across all our pillars.
spk02: I'm now happy to answer questions. Operator?
spk12: Thank you. Ladies and gentlemen, we will now be conducting the question and answer session. If you would like to ask a question, please press the star key followed by the number one on your touch-tone phone. A confirmation tone will indicate that your line is in the question queue. If you'd like to withdraw your question, please press the star key followed by the number two. If you are using speaker equipment, please lift up the handset before making your selection. Our first question comes from Bruce Jackson of Benchmark Company. Please go ahead.
spk03: Hi, good morning. Very thorough job as usual, everybody. The one question I had was about, you touched on this, is the lung cancer study. Is this the one that's being done in France, in Lyon? And maybe you could, like, give us a few more details about that.
spk11: yeah actually there's been a lot going on both in taiwan as you know um where it was uh primarily a test in conjunction with low-dose ct scanning and results have been very good there and that's been published soon with the aim of putting that as part of the taiwanese screening program and we'll be updating a lot more on that later and also the lung cancer work and this is all with our original nuku platform not even our new capture pcr so it's kind of It's funny, everything's kind of working at the same time after a lot of years of only having one or two products. And that is a mixture of deciding who goes to palliative care and who goes to treatment. And that's also worked very well. And they're also keen to use that clinically as well. So obviously, with all the work that's going on now with the sepsis side, which, as Andy said, is going incredibly well, And all aside from all the other things, the focus on the product side has not been there, but it's something which is working very well. As I said, it seems to be everything seems to be working at the same time. So we'll put some focus on that and starting with the publications. And both of them could be used clinically in those countries in France sometime later this year, early next year, and then Taiwan once it's added to the national screening program. So both of those are very exciting developments. Anyone from our team want to say anything else about the lung cancer?
spk02: Nope, that covered it? Okay. Bruce, did that cover your question? Yes.
spk08: Yes, that's fabulous. Thank you very much. Thanks. Have a great day.
spk12: Our next question comes from Tim Moore of EF Hutton. Please go ahead.
spk00: Thanks, and congratulations on the timing of the launches over the last six weeks. Like you said, so many things are coming together at once, you know, pretty much since late March. It's really good to see. I know investors have been hanging in there. You're executing very well. And I was wondering, you know, maybe if you didn't mind giving some color and feedback. You know, I know it's super early, but just what are your thoughts on kind of the feedback and traction, you know, at the veterinarians? I know the rollout just pretty much started in the U.S., but, you know, vets are probably educating dog owners about it at their annual checkup. the canine test, and just anything you can add on that, any incidental antidotes.
spk11: Yeah, there's a lot of going on there. So I think, obviously, our existing partners, there's been some time for them to ramp up, but I think that's understandable looking at it so far as there has never been an oncology test in the veterinary space for screening, certainly not something that's routine and easy to run like ours. So there's a vet-by-vet education process and also how to use the products There was also, I think, a little bit of market confusion. There was another test on the market from our friends at PetDX, and that's actually cleared now. They are no longer selling their test. It was something at a very high price point, so it obviously struggled in the market. It's no longer around. So I think we have a clear path. I think one of the very exciting things with the greater access that we are now developing through the in-hospital test with Antec and with Fuji in Japan, which has only just started, so we should see that coming through later in the year, has been the great feedback from key opinion leaders. If you looked at the releases from both companies, some of the best vets in the planet were extremely excited about our product and going forward. Also, of course, Antec did a large validation study before it put it onto the machine and it's got the machine working very, very well. So I think from the vet perspectives, it's a building process which is going on in the US and I think the extra access from now, I said it's the two biggest vet companies on the planet and also the biggest in Japan and also through Europe is very encouraging and the feedback we're getting from the vets and through those companies, not just our vets but also theirs, has been excellent. And we also got great feedback most recently from Japan from their first use of the product. But this is a development process. There is a lot of work. They are going vet by vet to get them to add it to their normal process. So it is something which will take some time to get through. But we have a fantastic product. It's very low cost. The new access through Antec and through Fuji are both less than $40 to the vet. So we expect a lot of good developments throughout the end of this year and next year.
spk00: Great, Cameron. And like you mentioned earlier in your remarks, I mean, that price point below 40 was definitely very impressive. And I'm glad there's buy-in on that, you know, for initial traction and awareness. Seems like a no-brainer for dog owners. The only other quick question I had was on human sepsis. You know, you're working hard on that. You mentioned, you know, the patients and just the studies. Can you just give us a little bit more of a time frame around that as you look out over the next year, year and a half? Can you kind of just maybe walk us through the timeline and your plan on that? Because it's a huge opportunity, and everyone thinks it's pet testing, but the sepsis could be a huge catalyst. I'd love to hear more about the timeline.
spk11: I think the sepsis is obviously going to be a massive deal because, as Andy very well pointed out, This is an absolute potentially game changer in the diagnosis and treatment of sepsis. And our test, as we discussed, is always going to be low cost, easy to use on a range of platforms. So to get there, this is bigger than volition. It's potentially such a blockbuster product, we don't presume that we could launch them internationally ourselves. So we have a very similar model, which has worked so well in the vet space to license it out. To license it out, we need a large data, which Andy went through very well on the call. We're expecting a lot of that in the next month or two to fill out the data room. We have very strong interest from a range of large companies, and I think the clincher for that is getting large amounts of data. And as Andy said, it's coming up with at least six potential endpoints. How do we correlate with the current sepsis 3 definition? Disease severity, intensive care mortality, 28-day mortality, duration of organ support, and length of stay. So it's a huge amount of data. And the trials which we're running, some of them have hundreds of data points per patient. So they're very, very large studies with fantastic institutions. Two of the big ones, they've run the samples already and we're analyzing them now, as Andy pointed out. So that's something which is coming up quite quickly. And as, of course, we're keen to get the information out, so for the potential partners to license the product, and we're also aiming to publish where we can in MedArchive, because sometimes, obviously, a large publication can take several months or a few quarters to actually get published. We're keen where we can to publish that early on MedArchive. And, of course, there's also our own prospective study, which we're now calling Include, which was called the DOCRO study, And that should also be reading out the next two months as well. So a very large amount of data, which with a very exciting endpoints. And we're very encouraged with everything we've seen so far. And I think there's a very good chance they'll become the key points for the data room so we can license them as quickly as possible. And the target is to license the sepsis side within the next 12 months and hopefully the cancer PCR this year. So it's all in the mail now, I think.
spk00: Great. Well, thanks so much. I'm looking forward to meeting Gail tomorrow at our annual EF Hutton conference. Thanks.
spk11: Yes, I'll be looking forward to it too.
spk02: Thanks for your time.
spk12: Our next question comes from Ilya Zipkov of Freedom Broker.
spk02: Please go ahead.
spk08: Good morning, and thank you for taking my question.
spk07: I have a short one. on the CapturePCR. Do you see CapturePCR test as a potential product for the biopharma R&D market beyond point of care and hospital screening? Could you elaborate on this?
spk11: Yes, I think it's a big, it's a whole new technology, the first group ever to concentrate the, as Andy said, the chromatin from the cancer. Also, the smaller fragments are incredibly important. And as our chief scientist points out, it's a whole new array of biomarkers because no one's ever looked at these fragments and concentrated them before. So there's a lot of potential uses. The biggest market of all is screening, of course, for cancer. But also there are tremendous amounts of uses in a wide range of areas. If you look at our NUQ platform, which is currently obviously what is used in the vet space and the lung cancer trials, which we talked about just earlier, There's a lot of work being done in our Discover program. We have over a dozen organizations working with us using our platform and some of those drug efficacy and a whole lot of, as you said, other ways of using it. I'd certainly expect once we have the paper and once we're in the process of licensing, there's a very wide range of uses they could use that platform for as we have had on the NUKU platform through NUKU Discover. I don't think it's possible to overstate how important what we've done is in the human space and the animal space. We've got the only platform which can, as I said, do all the things we've said. So it should have a very important role in a very wide range of other uses beyond screening, yes.
spk08: Great. Thank you. This is from me for now.
spk02: Thank you. Take care. Our next question comes from Stephen Rolston of Zax. Please go ahead. Good morning. Good morning.
spk04: Some thought to the rollout of new cuvette, especially here in the United States, Europe, and Japan. It's imminent or ongoing right now. It seems like a certain percentage of of the test will come back positive. And those obviously will, those canines will require a treatment. And that brings you into the monitoring aspect. Now, I know there was a paper back by Dr. Wilson-Robles about monitoring about a year ago. What is the procedure? Would the vets have to use that off-label to monitor? And it seems like those tests would be rather sticky in that they would be regular over very relative short timeframes in order to monitor the progress of the treatment. Could you comment on that?
spk11: Yes, absolutely. I'll comment firstly, then ask Gail to comment on where we are on the monitoring side, but yes. So it would be the same test and whether it's off-label or on-label depends on obviously if there's a publication showing it and it would be something which you'd probably do at least once or twice every month or two when the animal is in relapse. So it's something which could be 10 or 20 tests per animal instead of just the once for screening. So it's something which is a huge potential market. If there's six million dogs in the U.S. that get cancer every year, if you do five or ten tests per dog on the monitoring side, that's a huge total addressable market and something which obviously would be a huge market. Someone else on the call want to comment exactly where we are with the monitoring?
spk06: Yeah, I'm happy, Cameron, to add a little bit of context. So yes, we're working on the monitoring claim, if you will. What we wanted to avoid is as we're launching screening to add another indication at the same time. So our key focus has been on screening initially, and we started discussion with our partners now to add the additional use. So it won't be, as you mentioned, off-label. It will be something that we back. We just want to make sure, as we're educating the market, we don't create confusion. So we are sticking to screening for now, and later this year, early next, we'll launch the monitoring.
spk02: Thank you. Thank you. Yes, it does.
spk04: Thank you. If we could just switch over to sepsis. It seems like you have a slew of papers coming forward with all this data coming through, but it seems like the tip of the spear of this expected series of sepsis studies is Dr. Redder's clinical study that he did mention has been submitted. Could you get a little more granular about that? Because that seems like it'll be the first paper data point that we'll hear about.
spk11: Andy, do you want to discuss what data points are most likely in the timing?
spk09: Yeah, thank you. I can answer that. I think the two retrospective studies will publish first. I've seen data already from both of those. We will write them up and submit them for publication, and hopefully that data will be in the public sphere by the end of this year, by the end of Q4. The study at St Thomas's will finish recruiting in May, June 2025. So I wouldn't expect, we won't publish data from that for a little while afterwards. But we have, we've got five studies ongoing at the moment and two or three should report out before then. I hope that answers your question. We do have data that we are allowed to share in our confidential data room as well, understand the data analysis and then re-analysis as we understand the data better and can provide a richer picture of the results. I hope that answers your question.
spk04: Yes, it does. Thank you.
spk11: And Stephen, I think it's probably important to say just at this point as well, so we obviously have invested a lot over the last six months, eight months to get a lot of data. Andy's gone through the trials and they'll be ready in the data room starting from next month, hopefully, and some very large ones which have already been run. and the prospective ones in a month for our own internal and sometime next year, but a huge amount of data coming very soon. And that was something very important to us. We wanted to make sure we did the effort to make sure we had the very large amount of data that we think is needed to get a good licensee interested in licensing in one of the big diagnostic companies to really launch as quickly as possible. And we backed ourselves to get that done, and we're very close to getting that done now. So I think the team, I'd like to congratulate everyone in the Volition team They've worked tremendously hard over the last few quarters to get all the capture PCR data ready, get all the sepsis data ready, work with the teams in Taiwan and Leon on getting all the lung data ready. And there's a huge avalanche of it coming now, starting in the next few weeks, and it'll go all the way through the year. And I think that'll be crucial in the very large licensing deals we expect to happen now.
spk04: Thank you. Just one last question on the cost-cutting. I mentioned that at the last conference call. It was obvious in the fourth quarter that some costs had been declining, and I'm just looking at the financial statements now, and it looks like at least 25% of the $10 million goal has been achieved, but there's always a lag in cost-cutting. And I'm just wondering when these things have been implemented, especially the executives taking some of their fees in stock. When was that implemented? And do you have a sort of a guideline of how much you've accomplished in the cost-cutting so far?
spk08: Derek, do you want to take that?
spk02: Yeah, sure.
spk10: Most of the $10 million will come in the balance of the year, or rather the run rate will reduce over the balance of the year. So our intention is to get to a point where going into next year, we'll have $10 million less in expenditure available. from an OPEX point of view. But obviously, that's going to take time to come. And we have already made a good start, but it's from the second quarter rather than the first quarter. Savings that you might see in the first quarter were actually from a previously announced round of savings that we made. If you recall, we mentioned that back in Q3. so you should see a continuation um of that reduction through the balance of the year um the the the main savings will start this quarter and then we'll continue until we're on a run rate which is about 10 million less by the end of the year does that uh answer your question steve and to be clear steven the um the run rate uh to the the changes we announced
spk11: The last lot was $2 million or just a little around that. This is an addition. There's a 10 addition to that. So it's not 10 in total, but this is a new 10 we're doing now. And the reductions in our salaries to switching to equity will be starting this month and next month and throughout the end of the year or for at least six months. So they're starting right now, and then it'll be a strong process through the end of the year to get to where we need to get to. But this $10 million is in addition to the ones we announced before, just to be clear.
spk04: Yes, thank you. That's more information than I expected. Thank you very much. Thank you for taking the time.
spk02: Excellent. Thanks for your time. Thanks, Stephen.
spk12: Our next question comes from Richard Deutsch of Sata Securities. Please go ahead. Yes.
spk01: Thank you for taking my call and for doing such important work in what would be two very exciting companies if they were separated. Just a question. You're placing your cancer tests in the veterinary offices and in the laboratory. Are there any other venues such as these pet grooming franchises where these tests could be used? located and produce extra revenue for those businesses?
spk08: Okay.
spk06: Yes. So for now, we're really focusing on the large vet reference labs and point of care, but we have no plan at this stage to expand beyond. As we scale, that's something we might look into, but not for now.
spk11: And I think that that's exactly right but I'd just like to say what the fantastic thing with our platform is it can be done on a small machine like the Antec machine, it can be done in a lab, it can be done on a lateral flow, it can be done on a very large auto analyzer. So that's the fantastic thing and the variability of our platform which gives us tremendous strength and they each have a very important use as you said at different areas in different locations. and we have developed it now on the microtiter plates on the i-10 which is now part of perconelma also uh the antec machine and also we work on lateral flow and so it's and and all the large auto analyzers the big companies have when we're doing the licensing deals for example for example in sepsis um and coagulation they should be able to adapt to all their machines as well so it's amazingly adaptable um going forward thank you
spk02: Thank you.
spk12: Ladies and gentlemen, we have reached the end of our question and answer session. I will now hand over to Cameron Reynolds for closing remarks.
spk11: Thank you everyone for joining us today. It's obviously a very critical time for us now that we have a very wide range of technologies and products we're commercialising and it should be a very interesting back end of the year, particularly with the ongoing data rooms and licensing discussions in both the human cancer and the sepsis space, and, of course, with the deals we have just signed in the veterinary space. So it should be a very, very important and exciting end of the year, and thank you again for your interest and volition. Bye.
spk12: Thank you. Ladies and gentlemen, that concludes today's event. Thank you for attending, and even I'll disconnect your line.
spk02: Thanks very much, Judith. Thank you. Thank you, everyone. Thank you.
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