VolitionRx Limited (VNRX) Earnings Call Transcript & Summary

Good morning, everyone. Welcome to Volition's webinar this morning. The title is a Look at the Future of Cancer Diagnostic. I'm Gael Forterre, the Chief Commercial Officer of Volition. It's a pleasure to be here this morning. I'll start with a few words about Volition and our commercial strategy before handing it over to Andy for a discussion on our recent clinical evidence and Jake for discussion about the science behind our test, followed by a Q&A. So Volition, the company is an epigenetic diagnostic company. Epigenetic means it sits on top of the gene, it regulates the genes. So investment highlights. We have a large IP, which we started monetizing in 2021, focusing first on the animal side. And you can see some of the key achievements that we accomplished so far, licensing agreement with major vet companies, IDEXX, Antech initially with Heska, which has been acquired and Fuji to just name the biggest one. We also received $23 million in milestone payments and are working on getting another $5 million later this year. And in terms of sales, we sold more than 120,000 tests and components added to the test. On the human side, which we're starting to monetize, our activity is split between 2 main pillars, oncology and net. I mentioned we started the discussion in the fall of '24 and are progressing with a good number of leads on both pillars. And those discussions are based on recent clinical evidence and papers that have been published or are pending publication. In parallel, we're running an early access program with early adopters and hospital systems in Europe. So both on the oncology and NET side. It's just worth mentioning that the overall strategy, which I'll expand on a little bit later, is a low OpEx for Volition and low CapEx for partners. And I'll explain what it means in a few minutes. Our human pillars are focused on large unmet needs and addressable market. So just to name a couple, on the lung cancer side, whether it's screening or disease management, we're talking about billions dollar opportunities. Sepsis. The testing and monitoring of ICU patients alone is, again, another $1 billion market. And then obviously, we have other additional markets that we're looking at. So broadly, this is a very large addressable market, and we are expecting that we will take significant share. Now a few quick words about our technology. Our tests are very cost effective and can be adapted to a large number of existing platforms and both on the point of care and reference lab. And that allows for large market access. And this is one of the reasons the licensing route make a lot of sense for us. So go-to-market strategy. In terms of go-to-market, Volition focuses on the R&D, nurtures the KOL and launch those early access programs that I mentioned. We then monetize the core of our IP with large commercial and licensing contracts, which include both upfront milestones, but also royalty and the sale of key components. Now taking the example of the vet market, we led with clinical evidence, papers, then we had an early access program with Texas CNM, followed by a series of licensing and distribution agreements, and I mentioned Heska, now part of Antech, Fuji, IDEXX, again, to name just the biggest one. So a similar process has been put in motion on the human side. I mentioned in our previous webinar, the KOL and early adopter programs we have on the Nets and sepsis side. Well, we're following that same strategy with cancer, although with a few nuances. So those programs allow us to continue to build clinical evidence, onboard new KOL and drive adoption. And as importantly, if not more, those KOLs are also working with us to support our licensing discussion and the adoption in national screening programs. Now on the oncology licensing side, our discussions are progressing on multiple fronts, including capture and Nu.Q Cancer. Regarding Nu.Q, I'll separate screening and disease management because those are really different indications and categories of indication. On the screening side, we're in active discussion with 2 national programs. And obviously, you heard about Taiwan in the recent press release. As far as disease management, the body of evidence is growing and with it, the interest of large players with significant installed base as we fit nicely into the existing venue. So we believe we have a unique value proposition in terms of cost, workflow, clinical utility and can add a lot of value to the current standard of care. Andy and Jake will share more about this in a few minutes. Our goal is to sign a few agreements this year, some may be exclusive, other nonexclusive. It will depend on the indication, the level of clinical evidence, the development stage of the product as well as the competitive landscape.With that said, I'll now hand it over to Dr. Andy Retter, our Chief Medical Officer. Andy?

Good morning, everybody. Thank you, Gael, and welcome to our cancer webinar. I'm delighted to pick up and expand on data Volition collected related to lung cancer and pick up from references I made in the earnings call a few days ago. 1 in 6 deaths worldwide are caused by cancer. That's over 20 million cases a year and approximately 10 million deaths. One in 5 people will develop cancer in their lifetime. Within cancer, lung cancer is the leading cause of all cancer-related deaths with about 1.8 million deaths a year. Unfortunately, we all know lung cancer is often diagnosed late and at a stage where it's inoperable and only palliative therapies can be started. There's a lot of interest and many countries are starting to develop lung cancer screening programs. I'll pick up on that in a minute, but we believe that Volition has developed a product with potentially a unique place to help with the screening of these patients. Volition's area of expertise is nucleosome technology, understanding modifications and changes in nucleosomes that occur through the cell cycle can reveal deep insights into the biology of the cell and what's going on. And we've been able to interpret these signals to help us in the cancer space with the diagnosis, monitoring and screening of patients with cancer. That principle is picked up in this slide here, showing where we can apply nucleosome Nu.Q technology in the early detection and screening of cancer. That's particularly important for lung cancer. In the molecular profiling, we can detect and determine a very interesting new signature related to lung cancer. We can also use this signature to track minimal residual disease and spot when patients' disease is recurring too. Finally, we can use it as a measure to assess treatment response in patients as well. So it's a tremendously broad application of this technology, hopefully empowering clinicians to facilitate patient care. Many countries are now starting screening programs for lung cancer. This screening focuses predominantly on low-dose CT scanning. Although this is a powerful technology and has improved at the rate of early diagnosis, there are a number of problems and wrinkles to iron out in the process. There is a relatively high rate of false positives. Understandably, this can lead to distress and anxiety for patients and the potential for further interventions, be it repeat CT scans or more invasively biopsies. Oncologists need a reliable, simple, reproducible, fast, cost-effective test to help improve specificity for lung cancer screening and to help provide a tailored treatment which can detect disease early and detect disease recurrence early and help assess the response to treatment. This information will potentially revolutionize treatment decisions and the timing of treatment decisions. Volition has conducted a range of studies from retrospective to more recently prospective blinded longitudinal studies in lung cancer. The cohort sizes range from 70 to just over 1,000 patients, and they cover the detection of lung cancer at diagnosis and its monitoring during treatment. Key outcome measures demonstrate the clinical utility, and we'll expand on those in a moment, specifically with the sensitivity and specificity, positive predictive values, aiding rule in and rule out diagnosis, overall survival, minimal residual disease and the prediction of recurrence. This information is invaluable, adding to the clinician's knowledge of the patient's condition and the patient's trajectory. This slide summarizes our key research objectives and centers that we're working with and publications that we've produced and publications that are works in progress with estimated times for publication listed. In summary, our lung cancer package, there are 3 products. Product one, a screening tool, including H3.1-nucleosomes and H3K27 trimethyl in combination with low-dose CT. This package improves the specificity of low-dose CT scanning and can avoid up to 50% of biopsies in patients. Product two is used to first diagnose a patient. The Nu.Q technology serves as a prognostic indicator, identifying a subset of patients who may benefit from immunotherapy. It also identifies a subset of patients with an improved prognosis and therefore, this can help tailor treatment decisions. The third product, again, based on Nu.Q technology is about the detection of recurrent disease and response to treatment. And now this is the exciting part, looking at the real data. And so we're diving into the NTU Taiwan lung cancer screening data now. This is the combination of H3.1 nucleosome and H3K27 trimethyl -- sorry, is a little bit of a mouthful that name to help in the combination with low-dose CT scan to diagnose lung cancer. And you can see the rock curve, receiver operating characteristic curve here, generating an area under the curve of patients with lung cancer. The most important thing to identify is the methylation model. That's the Nu.Q powered model and the improved area under the curve for detection of lung cancer here. And we have compared it to a model from the Mayo Clinic and the Veterans Associations model, all of which are standard practice. You can see some very raw data in the middle panel of this slide and shows how we were able to identify our cutoff between benign and malignant nodules. Finally, this is some very raw data on the right-hand side of the slide, showing how we were able to calculate the positive predictive and negative predictive values for our Nu.Q-powered model. This data is published in a peer-reviewed journal and is available on Volition's website. Our colleagues at NTU are so excited by this data that they've adopted it in a prospective study in their screening program. We're tremendously excited to be working with them to try and help the diagnosis of lung cancer and improve the care of patients. I find this next slide incredibly interesting. This is product 2, our next use case, and it's really picking up the value of H3K27 trimethyl here. What you can see is the difference in the H3K27 level between those patients with potentially curative disease and those patients who are potentially for disease palliation. Here, we can see that new Nu.Q is predicting survival among patients with non-small cell lung cancer. In this study, all the patients have been considered for palliative care at the end stage of disease. This shows the different trajectories of the patients followed, and that trajectory is determined or influenced at least in part by H3K27 trimethyl. This is potentially extremely valuable to clinicians and to patients. It enables us to bring extra data into the clinical arena. So when you're sitting down talking to patients, you can give a more reliable, more accurate information about a patient's prognosis and trajectory. You can see the potential for this to be directly taken into treatment decisions and determining potentially future or not future therapies for patients. And again, this links back to physician's key aim of diagnostic enrichment and prognostic enrichment, really getting the right therapies and the right treatments to the right patients. Again, this slide relates to product 2, and it's just picking up and expanding on the comments I made a few moments ago. H3K27 trimethyl is independently predictive of survival and mutational status in patients with non-small cell lung cancer. It's an easy-to-track marker, which alerts on the risk of early disease progression. And again, as I said, it allows us to pick up a subset of patients who may benefit from immunotherapy. We're tremendously excited by this data, and you can see how with our colleagues in Lyon, we're continuing to build on it. This poster was presented at the European Lung Cancer Conference just a few days ago and is our most recent publication. What you can see is we're building on the earlier exploratory work and have an increased number of patients. What's reassuring and really positive and gives us great energy is that we're showing consistent signal that we identified earlier. H3K27 is predictive of survival in patients, certainly based on molecular profiling results related to circulating tumor DNA. This is a tremendously powerful tool, and we're continuing to build on it with further studies. The data completion from the poster I just showed you is complete, and the study is now being written up and will be submitted to a peer-reviewed journal as soon as possible. again, just picking up from the slide here, we're showing a clear separation in the titer or level of H3K27 between patients with disease and without disease. And you can see that with a higher level of H3K27, sadly, patients have a lower probability of survival. This diagram is trying to show how H3K27 nucleosome levels could help determine and inform personalized patient care. If the molecular patient of a profile is ctDNA negative and corresponds with a low level of H3K27, patients' overall survival is 20 months. Whereas if their circulating tumor DNA is negative, but they have a high level of H3K27, their survival is shortened to less than 15 months. You can see how the similar findings are true with circulating tumor DNA when it's positive. Again, a low and high level of H3K27 has a distinct impact on a patient's prognosis. And you can see how this will inform treatment decisions and allow patients and their relatives to plan. This data has given us and our colleagues in Lyon the confidence to take forward a 100-patient prospective validation study, which will be completed by the end of this year. This is the third application of H3K27 trimethyl. We will walk from left to right across this slide. You have a patient who has non-small cell lung cancer and received treatment. And the first question is, do they have circulating tumor DNA that we can identify? Yes or no. If their circulating tumor DNA is negative, we will assess their H3K27 for circulating Nu.Q. If circulating H3K27 is low, we'll continue with the current therapy. If it's positive or increasing, you will consider a change in the patient's therapy. Likewise, if their circulating tumor DNA is positive, and you're showing an increased level of H3K27, you may consider that the patient has progression of disease and you'll consider a change in treatment to a second-line therapy. There is a strong relationship between H3K27 and the cellular pathway mediated by EZH2 in cells. This is extremely exciting to us as there are EZH2 inhibitors coming to market. Again, you can see how we are using an evolving Nu.Q technology to really support that core principle of individualized patient care. We are extremely excited about the link between H3K27 and EZH2, and this has been the focus of a large amount of work by our Nu.Q Discover team. We will be able to share this data in an upcoming webinar in May. We're looking forward to being able to share that data with you, and we hope it will be transformative for patient care. This final slide summarizes our lung cancer package. Looking back, this is a tremendous moment for Volition. Volition is focused for many, many years now on trying to identify a biomarker to help with cancer diagnosis, screening and treatment. We're very much there with the combination of H3.1 nucleosomes in H3K27 trimethyl. We're building tremendous momentum with our existing publications. And as you can see, a series of planned publications going forward. This slide is just trying to summarize some of those publications going forward. You can see that we've started work with Gustave Roussy, the largest and one of the most famous cancer centers in the whole of Europe, and we're tremendously excited to be working with them. I hope you can understand from the previous slides where we can apply our technology in the very earlier stages of diagnosis of lung cancer. We can adapt and use the technology to help doctors tell patients and inform patients about treatment decisions and prognosis. And finally, pick up monitoring of disease and detection of minimal residual disease. We think this is tremendously powerful technology, shared in our data rooms, and we are very much using it as part of our discussions as we take licensing discussions forward. Gael will pick up more about the licensing discussions. I've -- that's it for our clinic data today. And I'd like to hand you over to Jake, our Chief Scientific Officer. Thank you for listening. Really exciting times for Volition. And most importantly, it's a technology we can bring to doctors and bring to patients to improve their care. Thank you.

I'm going to tell you a little bit now about some very recent developments in Volition on a Nu.Q technology measuring nucleosomes, which is, we think, particularly useful for screening. This Nu.Q technology is very exciting because it detects cancer with very few false positives. It's very specific and it detects most cancers. We've recently submitted an article describing the technology in detail so anybody can read how it works, and it's available publicly on medical archives. This slide looks a little complicated, but actually, it's quite simple. The green dots on the left represent the nucleosome levels measured using our new technology in 150 healthy volunteers of all different ages. The black dots are people who have a blood cancer, for example, a leukemia. The blue dots represent people who have a solid cancer, particularly the first 4 that you can see are lung, colorectal, breast and prostate cancer. And essentially, all of the blue dots and the black dots that are above the line, we can detect with this new technology as a cancer and the ones below not And what that means in reality is that we can detect half of all cancers. More importantly, we can detect all of the 4 big common cancers, lung cancers, colorectal cancers, breast cancers and prostate cancers. So what have we done differently to make this work? The assay itself is exactly the same. What we have done differently is used a different blood collection tube. And this particular blood collection tube stabilizes nucleosome so that we can better measure them when we eventually do our test. The really exciting part is on this slide. What this slide shows, again, the green dots are healthy people and the blue dots are people with cancer. But instead of separating it out by different cancer diseases, this time, it's separated out by stage. So we've got Stage 1 early cancer that is, by and large, curable, stage 2, stage 3 and eventually, of course, metastatic cancer in stage 4, which is largely incurable. And what is remarkable is that with a simple immunoassay, a rapid low-cost test, we can detect more than 1/3 of Stage 1 solid cancers, and that's a revolutionary breakthrough. This is something we've been really excited about. Detecting early stage 1 cancer is an ultimate goal in oncology, and we've been working towards this for many years. And we've now succeeded, and we think this is a low-cost accessible test that can be used worldwide. Moving on to the science. This is a picture of a nucleosome. And what I'd like you to take from this picture is that the nucleosome is quite unlike any other analyte that we measure in blood. It has a massive charge. This means it can be unstable in solution, especially if it's damaged. And in research, nucleosomes are normally cross-linked to stabilize them. What cross-linking means is effectively that they're chemically tied up to stop them falling apart and to retain its shape. Nucleosomes in cancer patients are often damaged and can be unstable. If they are unstable, we won't be able to measure them, but stabilizing them by cross-linking means that they're preserved to be measured later on. And what that stabilization means for the assay is that we can detect early Stage 1 cancer in many patients. This new development also allows us to distinguish nucleosomes that come from cancer from nucleosomes that come from other sources. So I'd just like to turn now to what does that mean for patients. using these cross-linking tubes also and preserving the nucleosomes so that they don't degenerate means that we can take a sample anywhere as well as lots of other advantages. So for example, lung cancer screening often takes place on trucks in supermarket car parks, for example. And it would be very, very simple to take a blood sample there and this sample can be stored and later taken to a lab for analysis. Turning to the assay itself. This, as I said before, is unchanged. We just use a slightly different sample. And the assay itself is available as a research use-only assay. So it's fully developed and analytically valid. It's automated and takes 47 minutes on an automatic system. We think this new way of measuring nucleosomes will have a lot of applications in the future. we think it will form the basis of a low-cost detection method for finding cancer early before it's spread around the body. It will also be useful for monitoring patients for residual disease after treatment and further applications as well. I'd like to briefly mention something about CaptureSeq, which is another exciting technology that we've recently developed at Volition. This also is looking at circulating chromosome fragments in the blood. But in this case, rather than nucleosomes, we're looking at transcription factor DNA complexes. I'm personally very excited with all of our recent developments because they really validate what we've been doing at Volition over the past 10 years, which is based in a philosophy that rather than looking at only the DNA, we look at the whole chromosome fragment that circulates. And both of these technologies are now the subject of licensing discussions. And with that, I'd like to hand back to Gael. Thank you.

Thank you, Jake. So here, you can see a summary of our licensing portfolio with the different indications and where we are in the value curve. And obviously, this is what we are discussing with our licensing partners. In summary, Volition is a publicly listed NYSE company. We are at the commercial stage. We develop low cost and early detection and treatment monitoring diagnostic, both for the human and the animal health. The disease area represent large unmet needs, and they're global killers, cancer, sepsis. We have a very significant market opportunity ahead of us. We so far received $23 million in milestone payments. And for 2025, we have the following targets. On Nu.Q Vets, we have already 8 licensing deals that are already selling, and we're going to grow those sales. On the Discover side, we're also going to grow sales on that front. And this is a program that is focusing on therapy company and helping them through clinical trials. And then on the NET and cancer side, you're going to see early access program generating early sales as well as licensing. And this is the core for this year. We're focusing on licensing contracts, and you'll hear more about it as they come. With that, I'll hand it over for Q&A. Thank you very much.

Thanks very much, team, and good morning and good afternoon, good evening, everybody. I'm Louise Batchelor. I'm the Group Chief Marketing and Communications Officer for Volition and your host for today's Q&A. I can see there's quite a few already queuing up, and I also received some in the background. Yes, I'm sorry, I thought there was indeed some background noise, but I had no power to control that. So apologies for the background noise at one point. So Andy, I'm going to come to you with the first question. So the question was Nu.Q has been proven to be effective in detecting canine cancers. What gives you the confidence that Nu.Q can be similarly effective in human cancer detection?

Thank you, Louise. So I think my answer to that question splits down to a number of parts, if I may. Nucleosome biology is incredibly consistently conserved across animal species and across your eukaryotic cell lines. It's kind of like a basic -- a fundamental basic component of the cells. And we know that structure exists that way. So there's a lot of biological plausibility to say that it will transfer from one sphere to another one. Two, we have validated all our work in the animal sphere, and we're very confident. And then it's understanding the biology, particularly there is real interest in the disruption of the EZH2 pathway, which we mentioned in the webinar. And that has a really well described link to H3K27 trimethyl, I have to practice saying, that's a little bit of a mouthful. But that really strong biological link, which allows us to envisage and see cellular disruption at a very detailed level, I think, is tremendously powerful. And it's why we're exploring that. and it's really exciting and reassuring to see the signal coming through, particularly in the data that we've demonstrated from Taiwan with our colleagues in Lyon as well. Thank you.

Yes. And certainly, I think the fact that the study size is also increasing now as we go through these studies, I think it's given us a lot more confidence from a human perspective. So Gael, a tricky one for you, I know, but we have it on most of these calls now. But the question is, without revealing names or identifying details, so obviously, people know that. But could you characterize anything about the commercial discussions that you're having with potential partners on the cancer side, specifically kind of what data do they need to see and what sort of questions are they asking? So maybe I'll come to you first and then Jake, I'll also come to you on this one.

Yes. Thank you, Louise. So we're progressing well. We have more than 10 ongoing discussions with large actors and split between NETs and oncology. There are different tracks, if you will, because you're not discussing the same thing when it comes to national screening program, whether it's an improvement of their test or effectively disease management. But if you're talking about the actors that are interested in the improvement of their existing test, Effectively, it's a technology evaluation to see how it performs within their operation. Then for the disease management, it's really based on the current papers and the series of papers that we discussed. Same thing. We have a few ongoing discussions there. And then obviously, the national screening program, again, different type of discussions. As we -- the only one that is public right now is Taiwan. So the one I mentioned, but you can see it's an evaluation trial perspective and with the goal to put it in -- or to include it in the program soon. So those are the 3 different tracks. We're progressing well. And obviously, our goal is to get deals on the book this year.

Sure. And Jake, from your perspective, what kind of data are you feeling that these companies are asking for? And what kind of questions are you receiving?

All right. Thanks, Louise. Yes, it's a good question. I think it varies quite a lot between companies. I mean one of the first things, of course, is how complementary what we do. How does fit with what other companies are doing, and we fit quite well with many. And then obviously, we need good data demonstrating that the test works both analytically, but more importantly, perhaps that it worked clinically. It's particularly good, I think, when the data doesn't come from us. So all of the lung cancer data, for example, that Andy shared that, that all comes from other people. So it's produced by hospitals in France and in Taiwan. So that's particularly good. And then the other side, I guess, is evaluation. So what one obvious answer to those sorts of questions is, well, we've got an automated system and we've got kits. Why don't you just have a go. And that's where we are with a number of companies now.

Great progress indeed. So just to answer a couple of questions on the chat as well. So the replay will be available after the call. So you can use the same link to access the replay, and we will also place on our website a copy of the slide deck from some of the information that is included in today's discussion. So a question from one of our long-term shareholders, great to have you on the call, Mike, is which therapy area do you think will be first to be out-licensed? Now you can all take your kick on this one, but I'll go to Gael first.

It's really a difficult one. I don't think I want to take a bet. They're progressing.

I think that, that would be a consistent answer from all of our panel actually is we really are progressing on all fronts at quite a pace. So we'll just have to wait and see. Along a similar line, one of the questions I was sent in advance was 5 years from now, what do you expect will be the biggest segment for Volition? Will it be vet, sepsis or human cancer. And I think that's worth each of you answering, if you don't mind, we're putting you on the on the hot seat. So Dr. Retter first.

Okay, so I'm going to give you a political answer. Volition's expertise is around nucleosomes and nucleosome biology. And we're very confident and increasingly seeing really positive signals across cancer, across Vet and across sepsis too. We can obviously see the questions in the chat, and we're desperate to commercialize this product. And I'm desperate as a doctor to bring this product to market so it can help patients. And if we do the right things for patients, that will be the right thing going forward, and that will enable us to generate significant cash flow and significant revenues. All of the markets are huge. The sepsis market is unbelievably large. It's potentially billions of dollars and hundreds of millions of patients across the world. So ultimately, if the test became extremely established and successful, that probably would be the largest revenue stream. But H3K27 is extremely exciting for how it reveals disruption at a cellular level, as I mentioned a few moments ago. And I think that we're already aware that's picking up quite a lot of interest with partners. And I think that's tremendously exciting too. And hopefully, will be very, very, very successful. But we understand the anxiety and we, too, are desperate to make this a commercial success as soon as possible. Thank you.

Okay. Jake, do you want to take it next in terms of which you think will be the biggest segment, sepsis or cancer?

Okay. So I think human will be bigger than vet. I think that's fairly easy. As for the other 2, I think that's very, very difficult. If I had to choose, I might choose sepsis and NETosis because I think that it would be used more often in every patient than for cancer. So even if it might be more patients and it might be more often. But difficult question.

Yes, especially given I'm going to guess that Gael might come on to the pricing, which we'll also see also shape the revenue potential. But Gael, what are your thoughts.

Yes. I think human has globally more money. So obviously, that should be the bigger market. And I think the product market fit in all those areas, vet, human oncology and human NETosis are big. In terms of sheer number, I think Andy is correct, the number of tests and patients on the NETosis side will be bigger. But the pricing will also be important. And I think on the oncology side, you see prices that are not in even the same category than on oncology. So between all those different factors, it is really difficult to know which one. I think they all will be significant business line in 5 years.

Thank you to all of you here for your honesty. So Jake, a question for you was for the first technology that you spoke about, it sounds quite early stage. How far is it from the market do you feel?

I think it's much further forward than you might expect actually because the test itself is a done deal. It's done and it's on the market and available, as I said. And the -- so really, it's just about what tube do you take the blood sample in, and those tubes are also available and on the market today. So far, we've tested about 400 people, something like 250 with cancer and 150 others. So on that level, it's reasonable numbers, but it's not big numbers yet. But looking at it from a sort of commercial perspective, that technology, we have an evaluation agreed with a large cancer company. And yes, actually, we have an evaluation agreed with the second technology as well. So although it might not be on sale in the market tomorrow, we are very well progressed with licensing discussions.

Yes. And then one, I think possibly I'll come to you first, Andy, and then maybe, Gael, you'll also want to answer. But are there opportunities to partner with immunotherapy companies, for example, as a companion diagnostic. Andy, do you want to take that first?

Yes.

Yes. And yes.

Yes and yes. Thank you for the question. Yes, there is. I can't say too much at the moment, but Gael referenced it in his part of the webinar. We are obviously in active discussions with a large number of interested partners. And actually, as I mentioned in my previous answer, really, it's a testament to [ Volition's ] understanding of nucleosome biology and the tests and the work we've done, particularly in Belgium and particularly in the innovation laboratory in California have enabled us to work hand in glove really with a number of companies to look at their products and test their products. And that's a really interesting area for us and hopefully it will become a very valuable revenue stream for us.

Yes. And certainly, just to give a little advert, the intention is very much to have a webinar focused around Nu.Q Discover as things have really started to take shape on Nu.Q Discover this year. So we hope to have another webinar in May or June around that.

Just to add, Lou, at least. so everyone can see, we've published at least 4 papers from the innovation laboratory in the last 14, 15 months, which speak testaments to that biology, and that has drawn a lot of attention and attracted interest from pharmaceutical companies and others, et cetera. And it's a really powerful testament to multiple peer-reviewed publications speaks to biology and hopefully helps with it -- definitely does help when we have licensing discussions and genuine discussions about technology transfer and the science that supports the tests going forward.

And Gael, do you want to add anything around Nu.Q Discover and the component...

I think we have those discussions ongoing. It's clearly an area of interest for therapeutic companies, whether it's net because we're talking about treatable traits trade as one of the characteristic of our test, oncology as well. So I think it's definitely reinforced the licensing discussions. When you do have therapy company come in and say, I really want to engage with you for Phase I, Phase II, Phase III and potentially more, that's very helpful.

Yes. Yes, absolutely. And I would also just sign people to the next webinar. And then another question from the chat is, will it be necessary to perform more validation studies for other screening programs? Or is the validation study for Taiwan enough to take it into discussions with other countries. So I think I can come to you first, Andy, if you'd like on that or...

It's not a simple answer to that question. Yes, it is enough to take it forward in Taiwan. And indeed, the team they have given a commitment that if the prospective study going forward, which they're really actively recruiting to and recruiting at quite a high rate works, they will adopt it into their national program. And to Europe and different to the U.S., they don't have to go through like the FDA or European Medicines Association, et cetera. And thought -- sorry voice on the line. In terms of other studies, they would have to -- in terms of other countries or regions, they would have to look at the data and make their own decision. But hopefully, it could be adopted really quite quickly into practice.

Yes. And certainly, one thing I would add to that is, actually, there's a lot of collaboration now across the different sites that have been doing studies. So for example, whilst we were at the European Lung Cancer Congress recently, there was a great meeting with the Taiwan and the Lyon team where they're rose cross-sharing learnings and things. So hopefully, that helps us move forward.

One of the things that's slightly easier in cancer as well is the ability to develop a laboratory-derived test. And clearly, there is huge appetite for novel diagnostics to be taken forward if they improve the care that you can deliver to patients and research is actually embedded into oncology. So the barriers to adoption is significantly reduced.

Sure. Was there anything you wanted to add on that, Gael, before we...

Maybe just that it helps, having one country and then more coming and using -- build the credibility. We see that in the discussions. But the large national screening program always want something from their own country as well. So I think it helps, but it's -- and maybe down the line, we'll see some countries adopting it without further because you'll have multiple countries having conducted some of their trial. But usually, some level of local clinical evidence is required.

Okay. And then, Andy, a slightly more technical question, and it's from one of our new analysts. So if we need to arrange a follow-up call, then outside of this call, I'm happy to do that. But he's just asking, please could we provide details about the specificity of LDCT versus Nu.Q cancer. Is the test meant to work similarly in clinical trajectory as, for example, Cologuard?

So we probably need to follow up slightly offline because I personally am not desperately familiar with Cologuard. So -- but the -- certainly, in the screening population, the combination test, so you're adding a blood test to a CT scan, and that increases the sensitivity and increases the specificity of the scan. Screening programs are really significantly increasing. And there's a real challenge for clinicians and looking at the density of the nodules in people's lungs, how solid they are, how much ground glass shadowing they have in them and their sort of density. And it's an incredibly difficult decision sometimes to decide if you watch and wait, if you scan again or if you biopsy. And that's really where the test is helping to provide information. It should reduce the number of biopsies that patients require. So that's reassuring for patients. It's reassuring for clinicians and actually enables more targeted allocation of resource to do biopsies in the patients that need biopsies. And that's absolutely how we see it moving forward, and that's why our colleagues in Taiwan are so interested.

Yes. Yes, that's clear. And another question, Gael for yourself, what specific products are CE marked. And what is the commercial traction or feedback that we're getting from clinicians.

We only have one effectively our Nu.Q net IVDD assay, and it's available on the technology, the platform that we operate with IDS. It is at a stage where we're onboarding sites for evaluation and with the purpose of commercial outcome, it's paid evaluation. We have -- I don't know if we can say it publicly with the number of sites or do we wait for the Nu.Q.

I'd say it is a handful of sites in Europe is probably what I would go with at the moment.

And it's progressing every month. We're getting more sites. So -- it's exciting because it brings a hospital system in starting to use it and build the clinical evidence, and that's a positive feedback loop with us. So they come with use cases we discussed. So good progress on that front.

Yes, certainly is. I think -- for me, one of the things I reflect on is it takes me back to when we first launched the Nu.Q Vet cancer test, and we started out with our colleagues out of Texas A&M, and they obviously generated a lot of the clinical evidence and then the test was available through their GI lab first and that actually in itself really gain the product some validation and then also our licensing partners and the confidence, et cetera. So I think it's having the sense of excellence around Europe for both oncology and for Nets, specifically sepsis, but also for the use cases within NETosis, I think, has been is really valuable.

Yes, I'll add just one, users that really love a test, and they are actors. They are actually actively promoting it to potential licensing partners. So it's interesting to see that dynamic.

Yes. Absolutely. Well, I'm very conscious of time. So I'd like to thank everybody for attending today. There is a great deal of data that we've gone through within this webinar. So as I said earlier, replay will be available just through the same link. We'll also post a short deck to the website. The clinical papers are housed within the Resources section on our website as well. So if you are wanting to have a look through some of the clinical papers. But if you do ever have any questions, then please don't hesitate to e-mail [email protected] or [email protected], and we'll do our best to answer them. But what I think all the panelists state, but what I would say is that as with the sepsis, the next webinar that we had last month and then this one this month, we really are starting to see a great body of clinical evidence now becoming available in the public domain, published in peer-reviewed journals with more to come. All of our clinical studies are now either completed or in progress. And so we're in a really great position to kind of finish off the licensing deals that are in discussion at the moment. So we look forward to see -- I think it will probably be the Q is our next element. And then after the Q, we'll do a discover webinar. But thanks very much, everybody, for attending today.