IXICO plc (IXI) Earnings Call Transcript & Summary

So welcome, everyone, to the IXICO 2025 Capital Markets Day. The usual disclaimer, which I won't dwell on, but the exciting part of the day is we've got the entire C-suite of IXICO here today. So we have Bram Goorden, who's the CEO, newly joined within the last year or so. We have Grant Nash, who's the Chief Operating Officer and Chief Financial Officer. We have Robin Wolz, who is the Chief Scientific Officer and Chief Medical Officer; and we have Mark Austin, who is the Chief Technology Officer. And I guess the purpose of the day today is really to think about the sort of things that we can't necessarily or don't have time to communicate at the H1 or H2 trading. So this is about a deeper dive into the kind of growth trajectory of the company, the innovation strategy the company is actively employing and then a deeper dive on the science and the technology. As you can see, it is quite a busy packed agenda. We do have 2 external people dialing in. So we will be quite disciplined on time. As Mark said, please ask questions throughout. We do have sort of Q&A sections. And for those in the room, we will also have the breaks if there's questions, you want to hold to the break, please do so. But ask questions throughout, please. The only thing I'd say, please don't do defend it if I do have to move people on if we're getting stuck on questions because as I said, we've got quite a tight schedule. But on that note, let me hand over, we're going to start off with Bram Goorden, who as you can see from the slide, is going to start to talk you through where the company is going next, where it's just come from the Innovate Lead Scale strategy and a little bit of an insight into what we think the future might look like for the company.

Well, thanks, James. James is Chief Business Officer, who joined officially, I think, around 6 months ago. He's also the Head of Investor Relations. So it's very comforting to have someone like him around for day like today. I'm delighted to be here. As James said, I have been with the company around a year now, a little bit over a year actually. Obviously I met quite a few faces that I see in the room. So it's great to see these familiar faces. It's great also to see some faces that I don't know yet. And I'm hoping that quite a few people or we noted actually quite a few people are joining us also remotely. It is very exciting to be able to not just bring the results, and we're actually avoiding to talk about '25 results because you know those, and we're very proud of them. But we're especially very excited about what's ahead. And so this is about the strategy going into '26, but also that more medium-term strategy, as many of you may remember that we did do a quite recent capital raise. And obviously, we want to report out also on what have we been doing since we did that and how do we measure our progress. And then, of course, after today, you can be the judge of that as well. So to start with the opportunity, it's a problem, which creates an opportunity, sources indicated 43% of the world population will, at some stage, be touched by a CNS disease, by a neurology psychiatry disease. So that means that almost half of the world population will be facing that societal challenge, which IXICO is all about. And so IXICO is very much a company that is mission-driven, and you will hopefully hear that also from the experts that you're going to hear today I want to point out, especially Robin and Mark as Chief Scientific and Chief Technology Officer, but then also with their teams, right? You will see in a minute who is the team at IXICO, and why have they chosen to be with IXICO. It's a problem obviously for society, which we're trying to help to solve, but it's also an opportunity in terms of the economics around it, if you wish. So the neurology market has a CAGR of 5% currently. In addition, for those who know the neurology, the CNS market a little bit, it has been sometimes qualified as a bit of a train wreck. It's hard to develop drugs that actually make it to market. But we've seen changes now, right? And we'll be talking about them. You'll also see Robin talk about Alzheimer's, for example, and some of the progress that has been made there. And so it's really a market now where we see a lot of progress happening as we speak. Having said that, it cannot be a one-fit-all solution. It will have to be through precision medicine where patients are identified, that are eligible to treatment where the right patients, especially are also recruited into clinical trials, and that is the business that IXICO is in. So a snapshot. I know quite a few people here probably don't need this, and you know as well, and you've been following and supporting us since quite a while. We are what we call an imaging CRO, an imaging clinical research organization. We're considering ourselves almost the exclusive, definitely the leading one in CNS. So in that neurology field, our competition is very much a group of generalists. And you may actually have seen in the news that one of our big competitors, Clario, just became a little bit bigger as they are now going into the Thermo Fisher Group. We exist since 20 years. So we are an established player, obviously, proudly here based in the U.K. and imaging is still very much that gold standard. So obviously, when you go and develop solutions in neurology, you will want and go to look in the brain. Luckily, we don't have to do that anymore by opening the brain, so to speak, but we do that through imaging, and so that is the business we're in. I mentioned already more than 90 people over the past year, more than 10 people have been joining also following the capital [ raise ] . So we feel that we have a strengthened group again, almost 1/3 are PhDs. So I would say quite a few smart people in the building. Many of them here in the U.K., but not only. So many different geographies and especially also at the other side of the pond. You see here 26 current studies ongoing, that may seem a lot or not a lot, depending on how you look at it. I think what's important to keep in mind is these are 26 potential solutions, blockbuster solutions that pharma or biotech are developing that might potentially come to the market. So we think this is a very impactful number to be part of. We rely on 1,250 centers -- clinical centers. We are radiology, where the scans, the imaging is being done, and we very easily activate other centers as well. So we are working with an even bigger network than that one. And so the core solutions are imaging, trial management, analytics, biomarker diagnostic validation. I really talked a little bit about the team. And I'm actually very proud to present that team. Some of these people have been with the company since a long time, and I think that's our strength. And especially, as I mentioned, Robin and Mark, who you will hear most of today have been establishing the platform as it is today and have, of course, been further developing and enriching it and I did promote Mark to Chief Technology Officer a few months ago, and that is a very clear signal also from us as a company to make sure that the architect of the platform will be out there much more as we also start to work with partners, and you'll hear Mark talk about that himself. Obviously, Grant as CFO and also Chief Operating Officer, is instrumental and has been instrumental to the company since a long time. And Robin has mentioned, has always been the Chief Scientist as we've now really built a platform that is serving many different disease areas. The people to the left are people that you probably have never met, potentially not even heard of, but Hannah, of course, is the Head of Talent is very important because there is a war on talent. And clearly, we -- as I said, we've got these people in the building. So Hannah's role is important. And then Hannah legal, John quality and regulatory are, of course, extremely important for an industry like ours as well because everything we do is highly regulated. I already mentioned, James, I'm very excited to have his strategic mind, part of my C-suite and you will probably see more of James in the future as well as we embark really more on a corporate development path as well. We've got Mark and Kate with us today. Mark is my chair. Mark probably doesn't need introduction to some of you. He's well known and he is a CEO of ChemAI. So he's a good sparing partner for me, but at the same time, also a great chair to have as he obviously knows the investor ecosystem. Kate, who is a prior executive -- financial executive with GSK, so obviously invaluable in the discussions as well. And I think Dipti has dialed in. She is a prior executive with IQVIA. And as you can imagine, that is great to have as an input into our discussions with the Board as well. So a small board, a nimble board, but very much leaning in, as you see today as well. I think this might actually be the most important slide that I wanted to show. We very rarely can share actually who we work with and what we do for them. We very much respect confidentiality. And so often, when you see these RNS is coming from us, we're talking about a Phase II trial, we'll probably give you the indication. And I will say with some maybe geographically situated biotech or biopharma. So those are actually 3 examples where we can actually clearly speak about who we're working with and what we're doing. And I do want to pause here for a moment. So the first one is the Global Alzheimer's platform. You may have seen a few months ago that we announced that we actually invested to their clients. They're actually a customer of ours where we do the analytics the entire Bio Hermes 1 and 2 trials, and they basically do a biomarker research, so they're front and center into what we do. But we've also invested in making sure that we are not necessarily an exclusive partner, but the imaging partner when it comes to accessing those data. And that is, of course, for us, the gold, which we sit on as an AI-driven company. The second one is uniQure. You may have seen that in the newspapers here in the U.K. as well. The people on this picture are not people from uniQure. They're actually from our own University College London here. Sarah Tabrizi, who's really a very well-known figure in the Huntington space. And they brought out a news that the FDA has given a clear signal that despite the fact that they've got a Phase I or II trial, there may be endpoints allowing them to get to FDA approval. So we've got quite a few phone calls actually from some of you as well; are you involved in this? And I think it is safe to say that when you see Huntington's disease in the news, you can assume that IXICO is involved. And so obviously, in this case as well, we're sharing the pride of their progress. And then the third one is Fujirebio, that's a diagnostics company. You'll hear me talk about this a little bit more. I did say that we want to go into other verticals. And so this is one of these verticals where we now see blood-based biomarkers come to market. This is the first one that was cleared by the FDA and they used us together with the data set from GAP to do that validation of their first diagnostic in Alzheimer's disease. So why is it the right time for IXICO now? With our share price here, we try not to look at this too much. We try to focus on other things such as the revenue increase. And this is, of course, what happened over the past year. We're proud of this. It's double digits. I think it's what we promised. We even overachieved this a little bit. Importantly, as I mentioned, we did a capital raise, which means we've got -- we're quite cash-rich for the size that we are. But we didn't do that as I always say internally as well to fill the coffers. We do this to invest, to grow and to execute on what we said we were going to do. And that's why you see that from an EBITDA perspective, we're still on that trajectory to profitability. Very confident and Grant will talk about what that horizon looks like. But I think we can say that we're very much on track when it comes to the execution of what we set out to do. I'll leave it up to you to judge, of course, on the valuation and the share price of our company at the moment. So I already mentioned it, the societal challenge. We are very much a mission-driven company, which means that people in the building very much are there to help solve problems in Alzheimer's, Parkinson's, Huntington's, and some of these other disease areas as well. And you see that, that is very fertile ground. Over the past 20 years, we've actually seen an 18-fold increase in the number of trials that have been initiated in that arena. I already mentioned some of these numbers, 43% of the population, which is 3.4 billion. I mentioned 5% CAGR for the neurology market, which includes pharma, but it's also 7% growth for the imaging market, which is very much the one which we are operating in. And you see here, and I think Robin is going to come back to that and provide some more color around it, 138 new assets in Alzheimer's alone that are being researched as we speak. So who are we? And how do we make that impact? And how is that evolving as well? We are, first and foremost, a technology platform. We operate as a clinical research organization. That's how we derive revenue most of the time, but it is very much driven by an AI-driven platform that has been completely revamped and actually marked, we'll have an opportunity to really show that and even showcase that today, I think. Linked to that, then are the experts. So the people that are sort of on our payroll are often thought leaders in their own right and will also interact on the global scientific platform. And so the business we're in is developing biomarkers or imaging biomarkers, managing trials from A to Z for our sponsors or clients and then analytics deriving insights which we feed back to pharma. And so the insights are largely around efficacy, safety and patient eligibility. I had quite a few discussions actually with some analysts lately as well. And I think the fact that we are very clearly focusing on CNS and on neurology is very much confirmed now is the right choice. We could easily have imaging go into oncology, go into other areas as well, but we do very much feel that we are sitting on very fertile ground in CNS. And so specialization is definitely the name of the game. It's highly technological. It's highly scientific. But at the end of the day, as you see on the bottom, it's actually informing financial decisions of our clients in terms of progressing their assets through the pipeline or potentially failing fast if they need to. So about a year ago, I started to talk about the Innovate Lead Scale strategy, and that's what I embarked on also together with the team. And just as a quick reminder, Innovate Lead Scale is about product differentiation, so bringing novel innovation on our technology platform to make an impact, as you may remember, especially in Alzheimer's and Parkinson's. Lead is about making more noise on the scientific platforms, I should say, and working with key opinion leaders in that regard. And then Scale, of course, is translating that into order book revenue and expanding that serviceable market into novel verticals. And so at the end of the day, it's all about accelerating especially revenue growth. And then from there, increasing the value of the company, which we do think relies also on its underlying technology, but I would say the name of the game at the moment is very much the revenue increase. So how are we doing? Or how do we think we're doing? And as I mentioned, you can be the judge of that as you look at our results and about what we present. We do think that in terms of innovation, and I am definitely very happy with what I've seen the teams build in terms of new AD, so Alzheimer's, Parkinson's product offerings, deployment of our next-generation platform, we pulled the trigger on that around a year ago that was under Mark's leadership, and that is working very well now, and then the diversification in terms of therapeutic areas. I did put a little white box here because this is not necessarily something we set ourselves out to do. So the new applications for our platform and how they could also penetrate revenues. I talked about that a little bit in a visionary fashion, but I do think over the past 12 months, I've really seen how this can actually be moving from a concept to reality. I think it's a bit early to start to make today about this, but I do think Mark is going to touch on that. Lead, again, people have come on board, key opinion leader relations have been built. Actually, one of the -- I think we can almost call him -- I don't know if he's listening already Robin, but sort of the gut of neuroimaging is dialing in today from San Francisco, Mike Weiner. And so those are all relationships that we have forged over the past months. So then when it comes to scale, existing project revenue expansion. So that is, again, the thought leadership of our people with existing clients that has really led to, I think, quite an extraordinary year of upselling, if I can call it like that for a moment, and then new biomarker revenues, which sort of comes back to that diagnostic vertical as well in which we're operating. I did give pipeline order book partnerships an amber because I think it is a bit early to be satisfied. We've got an ambition. The ambition is clearly to move as rapidly as possible to double-digit top line and of course, also maintain that double-digit growth. So I definitely don't want to make that green yet. And then in terms of company valuation, we give ourselves a red there. Again, I'll leave that up to you to be the judge. So with that, I'm going to let Grant sort of keep me honest, if you wish, and then I'll come back and talk a little bit more about the future.

Thank you, Bram. Good afternoon, everyone. I'm Grant Nash, I'm the Chief Financial Officer and Chief Operating Officer here at IXICO. It's a real pleasure to be here this afternoon. So Bram has just given an overview, a reminder, an introduction to IXICO, who IXICO are, what we do, why what we do matters, what the market looks like and why we are uniquely positioned to support the global pharmaceutical industry in addressing some of the world's most challenging neurodegenerative diseases. He's also provided a reminder, an introduction to our Innovate Lead Scale strategy, and provide that high-level self-appraisal of how we're doing. What I want to do is just put a little bit more flesh onto the bones of what we've done over the last 12 months. I also want to talk about how that augments the position we put ourselves in over the last few years and then how those come together to focus on what we're going to do in the next 12 months. As a reminder, this isn't a results road show. So I'm not going to go into the detail of the financials. We'll do that in December once we've got our audited numbers out. But I will start with the trading update that we released a couple of weeks ago, where we announced, as Bram said, that we have outperformed market expectations, 13% revenue growth in the last 12 months at GBP 6.5 million revenues. We've reduced our EBITDA losses, that is despite the fact that we've actually made a number of significant investments we'll come on to off the back of the capital raise and in line with our Innovate Lead Scale strategy. And where those -- the impact of those investments have obviously yet to fully come through. Cash of GBP 3.5 million and then an order book of GBP 13.8 million, so GBP 13.8 million of signed contracts, the revenues of which we'll be delivering over the coming few years. So those are the financials, but I also wanted to talk a little bit more about some of the other milestones, the other achievements that we've delivered across that same 12-month period. And obviously, this started for us in times of 12 months with that successful capital raise, GBP 3.7 million net of fees, almost exactly 12 months ago. Obviously, many of you were a key part and key supporters of that. So thank you very much. But that obviously was what drove us and allowed us to invest in this Innovate Lead Scale strategy. The strategy that Bram brought to the organization just over 12 months ago. And we have, over the last 12 months, added 8 new roles to the business, primarily in the areas of scientific and commercial, but also with this key focus on the U.S. Now we've been supporting trials in the U.S. for many years, but investing in the U.S. and having people on the ground in the U.S. in a market that is at least 50% of the market we're going after, we felt it was very important to augment our global credentials and really show to that market that we're there to support them in the U.S. On top of that, as Bram mentioned, we've also invested in our key opinion leader resource base. This is something that Robin will talk more about, and you'll hear from Mike as well shortly. But this is really important to us, firstly, from in terms of getting the leading advice in our Innovate strand where working with Robin to look at what are those things that we are looking to invest in? And are those the right things? But also in that lead element, the Innovate Lead Scale strategy, where we want to make sure that we're going out and we're talking to the market and augmenting that position of being the scientific leaders in neurodegenerative diseases, and having those experts who have that network able to support us to that has been very important. We've then supported that with this acquisition of data rights, they're working with the Global Alzheimer's platform to obtain access to this highly valuable AD data sets focused on MRI and PET, two different types of imaging protocol and blood-based biomarkers to support the developments that we're making. And the combination of those investments in people, the KOL support they're getting, access to data has then meant that over the last 12 months, we have been able to develop and deploy new analysis pipelines that differentiate us in those areas of AD and PD. So those have been the key focus of investments. Alongside that, we've also launched our IXI platform. This was something that we've been investing in over a number of years before that, key to us in terms of our technology capability, and Mark will talk more about that shortly. We've supported 37 projects in the year. That, of course, drove that 13% revenue growth. And alongside that, we've signed GBP 6.2 million of new contracts in the year. Now the key thing there is that of those GBP 6.2 million of contracts, GBP 4.2 million of those were actually signed in the second half, and then we've augmented that with a further GBP 900,000 of contracts signed in the first 2 weeks of this year. So that's important for us because in terms of developing our pipeline, developing order book, gaining traction coming through off the back of the investments we're making, is starting to show. So this is the next slide where I want to talk about the order book. But what I want to stop and just pause briefly is that, we've had a solid year of delivery over the last 12 months, and we've made those investments. Over the next 12 months, we're going to get the full benefit of the investments we've made over the last 12 months. But that builds on top of the order book that we already have. Now our order book at GBP 13.8 million is not quite as high as we'd like it to be, but it is very well structured and it's very well structured for growth. And I want to use this slide to explain why that's the case. This slide shows that order book at GBP 13.8 million cut in 2 ways. On the right-hand side of the slide, we've got the split by therapeutic indication. And on the left-hand side, the split by clinical phase. I'm going to spend more time on the clinical phase. But just to touch on the therapeutic indication, you can see from order book that we -- our order book is still very much weighted towards HD and rare other neurological conditions. That's something that we've got a very strong reputation for. But the areas we're focusing on with those investments is in AD and PD, which is about 25% of order book at this stage, and we'd expect that to shift more to those AD and PD areas. But perhaps what's more relevant, I think, to today is the makeup of the order book in terms of phase. And with the bulk of our order book, about 60%, 70% of order book being in Phase I, Phase II. That is very important in terms of the structural basis from which this organization can grow and how we can sustain that growth. And that is because most new trials that we'll win will tend to be in Phase I, Phase II. Once you're in a Phase I, Phase II, you tend to be stick with the CRO or the biopharmaceutical company will tend to stick with you as it moves to Phase III. So to win, you need to be in those Phase I, Phase IIs first. But by having a lot of Phase Is, Phase IIs, that also provides a diversification of risk in terms of the order book and an increase in the opportunity. So the more early phase trials you have because we know that we're working in an area where clinical trials don't always get all the way through Phase I, Phase II, Phase III, but we are well positioned to address any risk that arises should a trial fail. But at the same time, by having that breadth of contracts, we have 25 projects in order book at the end of September, we're in a good position to follow those through as they move from Phase I, Phase II into Phase III and that's what will drive sustained revenue growth for this organization going forward. So combining essentially the investments we've made over the last 12 months with an order book that is very well structured from a risk mitigation point of view and operational opportunity delivery -- sorry, operational and opportunity delivery structure, we have an order book in a good position. So I'm just going to move on to my final slide before passing back to Bram. And what we've done here is we are bringing together the investments we've made over the last 12 months and why they put in a position to win more in AD and PD with an order book that is already well structured for growth and then looked at what is it that we will deliver over the next 12 months that really ensure that we sustain growth going forward. And we've done some analysis work to look at what is the size of the opportunity that we can address today in the 3 markets of AD, PD and Rare, Huntington's disease. So the dark gray bar in the middle of this slide, that is our estimated market, so an estimated market for us to service today of GBP 40 million in AD, GBP 30 million in PD, GBP 13 million in HD & Rare. So we can see that the big opportunities are in AD and PD beyond HD & Rare. And then the light blue bar beneath that, is that element that we feel we have a good opportunity to address in the next 12 months. It's not the full bar because we know that some of these trials will already be in Phase I or Phase II and the chance of winning the Phase III, therefore, is at this point is low. Or we know that there are some biopharmas who work very closely with some of our competition and getting those trials initially will be difficult. So we've done an assessment of those market opportunities, that GBP 40 million, GBP 30 million and GBP 13 million that we realistically can go after. But then we brought that right down and said, all right, what are we going to win? What are the things we're definitely going to win in the next 12 months. And we're saying that we will win at least GBP 1 million of contracts in AD, at least GBP 1 million of contracts in PD, at least GBP 6 million of contracts in HD and Rare. And we feel very confident we can do that. When you total it up, that's obviously GBP 10 million of new bookings. We will also augment that with contract extensions. We have a good record of achieving that. We'll do at least GBP 2 million, we think of that. So with the investments we've made, building -- hitting this level of bookings would put us in a very strong position in terms of our order book in 12 months' time. And this is what we want to be coming back to talking to you about in 12 months' time having delivered this because getting that level of bookings puts us in a position where we know that we can sustain the growth that we have delivered over the last 12 months. And we'll achieve that over the last 12 months. And working with the investments we made and this order book, we'll put ourselves in a position where in the next couple of years, we will drive up to GBP 10 million of revenues, which will then move us back to profitability as an organization. So that's, if you like, here and now of the Innovate Lead Scale strategy. What I'm now going to do is pass back to Bram, who's going to talk about some of the potential to take us beyond that.

Thanks, Grant, and I'll try to keep it short. So we stay on our schedule. These are, I think, you heard Grant say this with a lot of confidence, and obviously, indeed, this is transformational for us as a business because it does bring us back to double-digit top line, double-digit growth and eventually profitability as well. But at the same time, these numbers may seem low. They seem low to me, to be honest, and it's not why I joined the company, to be honest. So really what we've set out to do. But of course, we need to make sure that we've got a solid basis where we start from. And I think that is what Grant has been presenting over the past minutes. Today, everything that we are enabling is happening in that upper right-hand corner as a clinical research organization, supporting clinical trials. And of course, when a product, a drug is being approved by FDA or EMA, post-marketing surveillance, which is following and making sure that further patient surveillance is happening for safety or efficacy reasons. But really what is exciting is to start to see what else can the platform do? And again, I won't steal Mark's thunder and Robin's thunder but we do believe that our platform can start to access other revenue streams that are not necessarily service or fee-for-service streams, and that will be through collaboration and through partnerships. And obviously, we need to equip our platform to do that. And so that's what we're working hard on. That's also why a CBO, for example, in the C-suite is very important. As we're talking to these multi-biomarker companies, large data analysis groups. Think of the VIVA as the mediators of this world, large-scale CROs who already today are our partners, IQVIA, ICON, PPD. And then imaging providers, of course, like the Siemens, the Philips and GE, who today, again, are already partners but not necessarily the way we've been looking at them sort of over the past months. And so those are the discussions that we're having. And then the other pillar is, of course, clinical decision-making where we do have a platform that could very easily in the hands of radiologists who today are using that already. You'll actually see that application from Mark. They could start to use that at the patient bed side as well. And so those are some of the, I think, exciting expansion areas, which will also be accessed through a different revenue model than what we are experiencing today, and that is the work in progress that is happening as we speak. And so I know this is a little bit cartoonish, but there is this confidence of the steel line of the company as is and to make sure that we deliver on these promises within the time lines that we've set as an iCRO. But then there's really that excitement to potentially, not necessarily completely walk away from who we are as a company, but to add that Tech Bio element, which is basically working through the technology, not necessarily through adding armies of people in the company as a service company, but really to start to look at licensing agreements and others with some of these bigger partners. So to end, I hope I've shown that, and you'll actually hear more from Robin in a minute that neurology, neurodegenerative diseases is the place to be in life sciences. It's a very exciting place to be. It's not always been like that. And IXICO, of course, has suffered from that. IXICO is still recovering from some of that, but we are really riding a wave. But at the same time, we don't just want to ride a wave. We want to be masters of our own destiny. And so the strategy is, of course, also to make sure that we actually start to equip ourselves through our technology platform to better access that opportunity in the future. And so I'm going to let this one be on your retina for another few minutes. This is sort of today where we are. But clearly, growing revenues will be the name of the game for the next coming 12 months still and beyond that, moving to profitability is the promise that we've made. But then increasing value, and you will see, we think value does not just sit in revenues today, but sits also into what's sort of under the hood, which is our technology. So with that, I'm going to end here, and let's look a little bit under the hood.

Thank you, Bram. So we're now going to move on for a slightly deeper dive on the science. So I'm delighted to introduce Robin Wolz, who's our Chief Medical Officer and Chief Scientific Officer, who's going to walk through a little bit more in the neurodegenerative market and then particularly on the scientific road map and how we're addressing that market.

Thank you, James, and good afternoon, everyone. So as James said, I'll build a little bit on what Bram has been showing in his slides and hopefully give more color to why we really think this is the time to do precision medicine in neuroscience, and it's actually happening as we will see in some of the following slides. So the chart on the left-hand side, you've seen in Bram's presentation, we see this very systematic, very nice increase in clinical trials that are being started and are being outsourced over the past years. What I'm particularly excited about is the graph on the right-hand side that actually shows biomarker use in clinical trials over period and the projection going into the future. And that's what I want to dive into more detail. You'll hear the word biomarker a lot today. So I'll take a step back and briefly recap what we mean by that. So biomarker is a measure that tracks with disease progression that basically tells us biologically what is happening, as the disease unfolds and therefore, is a very important and very valuable tool to understand drug effects and essentially validate treatment in clinical trials. What IXICO focuses on is biomarkers from imaging. So primarily brain imaging as we are a CNS-focused company. And for us, that means basically looking at images taken from an MRI or a PET scanner, PET machine, Positron Emission Tomography. It's basically, you will all have seen the imaging facilities in hospitals where a patient goes in and gets their scan taken in PET, that means radiotracer being injected into the subject that then is used to image and display molecules or proteins in the brain that help us understand disease progress. MRI on the other hand, Magnetic Resonance Images. We use strong magnetic fields to again, display tissue properties of the brain in this case. And that helps us visualize for example, structure and structural changes over time. I'd like to now go through the key therapeutic indications that we serve, and you've heard Bram and Grant refer to Alzheimer's disease, Parkinson's disease and Huntington's disease. I'd like to go through all of them and briefly discuss where we are with biomarker research, biomarker development and what role they play today in clinical trials already. So in Alzheimer's, specifically, we've come a long way over the past 10, 15 years. Many people today will have heard the -- how the disease develops and builds up. It starts with accumulation of a protein called amyloid in the brain, which then leads to a buildup of formation of tangles through another protein called Tau. This then downstream leads to neuronal loss, essentially loss of brain cells and neurodegeneration, which triggers the clinical symptoms that we all see in clinical dementia. If we think back 10, 15 years when first trials that were targeting amyloid, which is the core protein triggering this disease, so we had trials going into Phase III, 10, 15 years ago that were designed to treat or essentially reduce amyloid levels. These trials were designed in a way that we didn't actually check whether those subjects entering the trials have amyloid in the brain. So there's one Phase III trial that was run by Pfizer and Janssen at the time on a drug called bapineuzumab. It's a monoclonal antibody targeting amyloid. And after the trial concluded, looking at the data, it was confirmed that around 30% of the subjects actually don't have the pathology in the brain. So you're administering a drug to subjects that don't actually suffer from the disease. And I think this is a very nice illustration that shows the power of biomarkers. And if we now look at trials today, they would all be testing for amyloid. But I want to briefly before getting into that more detail, explain the biomarker model that we see on the slide here. So you're not just looking at the slide, it's the ATN framework that was introduced in 2010. It refers to amyloid-tau neurodegeneration. And what we see on the horizontal axis is essentially clinical stage of the disease and on the vertical access, we see biomarker abnormality. And as I've just explained, we see A beta, so amyloid becoming abnormal first, followed by Tau followed by brain structure, which is the neurodegenerative process, which then leads to downstream cognitive impairment and clinical worsening. 15 years later, this is implemented in every trial running in AD, specifically those targeting some of those underlying biomarkers like amyloid. So every trial would now be testing a subject for amyloid positivity before they enter the trial. And we also, as we will see later, these measurements are playing an increasingly important role in understanding treatment effect. So it really shows how we are doing precision medicine already in Alzheimer's disease. Today, the criteria embedded in diagnostic criteria, and we even see surrogate endpoints as we have approval of disease-modifying therapy in Alzheimer's and I'll come back to that later. I want to close by saying that imaging is central to all of this, all of those 3 categories that we have discussed can be measured through imaging. So we now have multiple radio tracers that allow us to image amyloid and tau. They are widely available. They are used in those trials and they are used for diagnostic purposes. MRI, on the other hand, is a key measure for -- to look at neurodegeneration. And as Bram pointed out, we see an emerging wave of measurements where some of this can now be measured through blood, and IXICO is partnering with these companies to look at that multimodal aspect. Finally, I want to say that we've seen a revision of those diagnostic criteria last year, where a new set of measurements has been added, which is vascular as a copathology in Alzheimer's disease. And the reason I'm mentioning it is this because I'll come back to it later when I talk about IXICO's R&D road map. If we zoom out of Alzheimer's disease and look at the bigger picture here for one moment, we now see similar momentum in other therapeutic indications that we had in Alzheimer's 10, 15 years ago. So what I've explained at length on the previous slide is really the journey that Alzheimer's went through from the first, developing the biomarker models conceptually through developing the actual measurements and then implementing them into trials. And we see movement in Huntington's into the same direction where in 2022, a conceptual model was proposed that stages the disease into different stages using biomarkers and other measurements. And the same has happened for Parkinson's only last year. So very recently. This now forms the foundation to go through similar steps that we've had in Alzheimer's in those indications in the coming years. And I will touch on this in the following slides as we specifically zoom into the work that IXICO is doing to support those trends in those indications as we're developing those novel biomarkers and bring them on to platform. I'd like to move on to, let's say, my second part of the presentation, where I want to briefly look at each of those 3 indications recap where we are in terms of drug development, how biomarkers are used today to then go into my last part and talk about how IXICO is playing in this space. As many people will know, Alzheimer's disease is the most common cause of dementia. Currently, we have more than 50 million people affected worldwide, and crucially and critically, this number is expected to increase by 150% over the next 25 years. And this is the thing to keep in mind that this problem is becoming bigger and bigger every year, and that is primarily driven by the aging population. So the biggest -- the single biggest risk factor to get Alzheimer's is age and with aging population globally, we see the significant increase in people being affected. I don't want to -- I'm not going to go into detail about this. You've heard Bram talk about 138 drugs being in development. I'm not going to go through them. Obviously, I want to show the graph on the right because it does illustrate the diversity we now see in targets, in approaches for drug development. It sees -- it shows a good spread across clinical phases of development, really illustrating the significant momentum we have in that space. I cannot present about Alzheimer's without emphasizing the significant highlights of the past couple of years for the field where we now have 3 disease-modifying therapies approved for treatment. All those drugs are targeting amyloid. We have drug from Lilly, Biogen and Eisai. And this is the first time we have disease-modifying therapy that actually treats the underlying biology of the disease as opposed to just addressing the symptoms, which is a major breakthrough. We have gone through and which is driving significant hope and also excitement in the field. I have mentioned already the increasing value that biomarkers is playing in that space, and that's reflected in the recent update to the FDA guidelines that recommend or encourage biomarker use across clinical stages of development. We see that happening. We have seen a biomarker of surrogacy in amyloid PET, which means amyloid PET has been considered a proxy for clinical benefit in those accelerated approvals we've had. So that's exactly where we want to get to with precision medicine. And I want to close by pointing to potentially very exciting and transformational topic for the field, which is the development of GLP-1 receptor agonist. Many people will have witnessed the significant impact those group of drugs is having on the diabetes and also obesity market. And we now see trials read out on GLP-1s being applied into Alzheimer's. We have Novo Nordisk present in a couple of weeks, most likely on their top line results, and we have Lilly also focusing in that space. And we'll come back to the topic as a deep dive in our fireside chat later on. Now moving on to Parkinson's disease, where similar -- as I've shown on the previous slides, we see now Parkinson's developing similar models of disease pathology and biomarker and biological staging as we have had in Alzheimer's several years ago, and that is reflected in the drug development landscape as well. To briefly recap, Parkinson's disease is a progressive neurodegenerative disorder that manifests in motor as well as nonmotor symptoms, including clinical dementia, it is, again, it's affecting 12 million people at the moment, but is expected to double over the coming 20, 25 years, again, similar to Alzheimer's driven by the aging population. It is driven by an aggregation of a protein called alpha-synuclein in the brain, which downstream leads to the loss of dopaminergic neurons and then leading to the cascade of clinical events. Imaging is another critical biomarker in this space. So molecular imaging techniques like PET, as I've explained earlier, are the gold standard assessment of dopaminergic loss and, therefore, critical for disease-modifying therapy trials. And we see recent progress in developing radiotracers to image alpha-synuclein, which would then put us in a position similar to what we have in Alzheimer's that we can actually identify subjects that suffer from the underlying pathology that we're treating in the trial as opposed to doing one-size-fits-all approach. Similar numbers, more than 130 drugs in development. Currently, no disease modifying therapy on the market, but the field is cautiously optimistic after not least an announcement that Roche put out several months ago about entering their anti-alpha-synuclein asset into Phase III following positive trends in clinical benefit as well as some trends on biomarker effect, and I'll come back to that when I talk about IXICO's road map, which is quite closely linked to these observations. Finishing off this part of the presentation with an overview on Huntington's disease. As Bram has outlined, it's an area that IXICO is very strong in where we are running most of the trials where we have a differentiated product portfolio and where we continue to innovate as well. Huntington's disease is a progressive neurodegeneration. Again, it's caused by a gene modification in this case. It leads to motor, cognition decline and also psychiatric decline. It is driven by neuronal loss in the brain region, specifically in stratum, which again puts MRI in particular, at the forefront of biomarker research just because that technology can capture the neuronal loss early on. It's an early onset disease affecting often subjects between 35 and 50 years of age, update required. And it's a rare disease, again, as Bram said, affecting around 5 to 10 subjects out of 100,000 in Europe. We had -- I'm not going to go into database because Bram has mentioned it. Great results by uniQure, really driving optimism in the field. First, therapy slowing the disease, a fast-track pathway with the FDA. In other news, we've seen Novartis announce the license arrangement with PTC Therapeutics, worth up to close to $3 million -- $3 billion, moving PTC's asset into Phase III development. Wave Life Sciences have announced plans to do a registrational trial on their asset. And interestingly, they have publicly announced to consider MRI-based measurements as surrogate end point in that trial. At IXICO, we are very proud and also excited to be working with all of these companies. And we can say this because it's public knowledge that uniQure, PTC and also Novartis and also Wave, apologies, are a part of the HD-IH consortium, which is a precompetitive consortium that IXICO has cofounded and that is working on implementing those biomarker protocols or these biomarker criteria I've explained earlier, Huntington disease for clinical trial use. And I'll come back to that in a minute. So with this, I'm going to be moving to the last part of my presentation where I talk about an update on our road map. So as Bram said, 12 to 18 months ago, we went out to present our Innovate Lead Scale strategy. And here, I'm going to give a brief update on the progress specifically on the Innovate part when it comes to development of differentiated product solutions in Alzheimer's and Parkinson's. Before I go there, briefly mentioning a milestone in Huntington's. As I just mentioned on the previous slide, we are active in this consortium with biopharma and nonprofit organizations. And we have reached a significant milestone this year where we've analyzed on the IXI platform the biggest MRI data set in Huntington's disease. And this now forms the foundation for the commercial partners to inform their trial planning, but it also together with our academic and commercial partners, we are working on essentially using this data set to defining the criteria to allow us to implement emerging biomarker staging criteria into clinical trial use. And this then allows sponsors to directly make those decisions through the IXICO platform because we've essentially calibrated it to -- we'll be able to do that. And now we'll only spend another 2 or 3 minutes because I know I'm behind time to briefly dive into an update on the vascular and the neuromelanin biomarker work that we've been doing over the past years. To set the scene, more than 50% of AD subjects do show pathology of cerebrovascular disease. So they show some vascular pathology in their brain, which is contributing potentially, most likely to the clinical dementia we're observing really. And as I said earlier, this has been integrated into the diagnostic framework now and underlines the important to understand those comorbidities as we plan clinical trials in Alzheimer's disease. Neuromelanin MRI, on the other hand, in Parkinson's disease has been proposed as a potentially sensitive and early marker of dopamine deficiency. As I mentioned earlier, this is a key hallmark of Parkinson's disease and being able to measure that in vivo sensitively through a noninvasive method like MRI opens up new opportunities in drug development, and we've just seen how Roche have actually presented promising result on an early version of that biomarker in their trial. So starting with vasculature, I'm not going to spend too much time on this, but what we see on the top end -- top part of this slide in the black box essentially is what it's called the drive criteria. It's not important to what that means or what it stands for. What it is, is an expert consensus paper essentially that was proposed 10 years ago to visually interpret, so look visually at MRI scans and then create the severity of vascular pathology in individual subject. As you might see, this involves more than a handful of different MRI images that an expert then reviews and assesses different types of pathology, which then gives an overall picture of subject's vascular state. What we see in the bottom part is progress we've made over the past months and before to put those measurements into our IXI platform. On the top hand on the top row, we see that all of those measurements are now available through an expert reader in the regulatory compliance, streamlined, fully accessible server platform, and I'll leave it to Mark to explain in more detail, what value that offers to clients. What I'm also excited about is the progress we see in the bottom part of the slide where we are increasingly now moving to automating those measurements through AI-based tools, so it doesn't rely -- this will not rely on visual interpretation by a trained expert, which comes with all caveats around reproducibility, training, cost and so on. This is an automated AI tool that provides a quantitative interpretation of those scans. And this is what we set out to develop in our Innovate Lead Scale strategy. And we're now seeing progress as these different assessments that are surrounded by the flu dots. And now going on platform. We have another set of tools that will be coming off that from later this year actually and going into 2026. And this really sets us up into a prime position to start engaging with those companies that are now looking at treatment linked to vasculature of the brain and that includes, for example, the GLP-1 receptor agonist I have mentioned and will again, come back to the topic as we have Mike in the fireside chat. Just wrapping up very quickly because I want to give you a glimpse into another exciting R&D project we're running at IXICO, and that is part of the Innovate strategy. So neuromelanin, it's a pigment in the brain, that is visible in brain structures like the substantia nigra, just putting some names out there. But what it essentially does, if those cells get lost or reduce as we -- it's kind of like dopamine, which uses during the disease stage. So if we measure neuromelanin, it basically gives us a direct measurement of dopamine deficiency. And you can see this here with the naked eye in this slide. So if you look to the normal healthy subjects on the left, you see this white rims in the center of the image. This is neuromelanin in the substantia nigra. If you look to the Parkinson's subject, you see a marked reduction intensity, illustrating the reduction in neuromelanin linked to dopaminergic loss. So being able to measure this on an MRI scan gives a direct measure of dopamine deficiency. The challenge is to do this accurately, robustly in clinical trials. And that's exactly what IXICO is focusing on. And I want to leave you with this slide again. If you look to the left, this is an image as it comes out of the MRI scanner, the arrow points to the substantia nigra and I think you will agree that it's difficult to see structure at all just because of the noise in the image. At IXICO, over the past year, we've developed a dedicated processing algorithm. So like an AI-based tool that analyzes the image and essentially creates the image that we see on the right, where even with the naked eye, we can now see those small rims of the substantia nigra neuromelanin appear. And this now forms the basis of an image that can be fed into an AI tool and then quantify it automatically. And this is what we're working on with one of the leading academic centers in this space and looking forward to presenting more results on that in the near term. Just before we move on, I'll want to finish with this. I want to maybe take a quick step back and emphasize again the excitement that I see personally and that I hope I've been able to bring across to some extent, at least to the audience today about the significant momentum we see across those therapeutic indication towards the adoption and implementation of precision medicine approaches in CNS clinical trials. We are proud and we are pleased to see that the -- almost the bets we took a couple of 12 to 18 months ago in investing in specific innovation areas are starting to show to be the right ones because we're seeing traction in that direction. We're seeing momentum towards the increased requirement for markers of vascular pathology, which is one of therapeutic -- one of the innovation areas as well as the value that a noninvasive measurement of dopamine deficiency like neuromelanin imaging can bring to PD trials. So in that, we are well positioned to enter this phase of physician medicine, and looking forward to it. And that's my last slide. I'm going to hand back to James.

Thank you, Robin. So we're now going to move on to a fireside chat. So we're going to have 15 minutes with Mike Weiner. So I just that might join.

Hello, everyone.

Hi, Mike. So just to introduce Mike very briefly. So Mike is a medical doctor. He is a world-renowned expert in neuroscience. In fact, he is a professor at University of California, San Francisco and he is Professor in urology, in radiology, in biomedical imaging, he is a medical doctor, as I've just said, and also a professor in psychiatry. And what's also interesting around Mike's background, he is the founder and the lead on a huge initiative in AD, which is the Alzheimer's disease neuro-imaging initiative, which is the largest study of its kind in Alzheimer's currently. And with that, I'll welcome back Robin to come and conduct the fireside chat. And then after this, just a reminder on the agenda, we go to a break. Sorry, go to Q&A, and then we go to break.

Thanks, James. Mike, thanks for joining. It's great to have you here, and I'm really looking forward to this discussion. You heard me point a couple of times to some topics that I think will be interesting for the audience to get into later in the discussion. But before we go there, I really like to hear your reflection almost on what we've seen in the presentation here on the exciting progress that we have in biomarker development over the past years, what impact that has on drug development, what the opportunity is for the next phase, not least since ADNI, I want to say this year has played such a pivotal role in achieving all of the things that I've tried to present about the roles of biomarkers and they're playing now I'm really honored to hear your perspective here on that.

Well, thanks, Robin. The progress in the last 15 years has been incredibly transformational. It's been revolutionary because prior to about 15 years ago, the only way that you could make a diagnosis with certainty of any neurologic disease was bio autopsy. The reason for that is that in contrast to all the other tissues of the body, you can't biopsy the brain. So the only way that you can get brain tissue for pathology is to wait for the person to die and then look at the tissue. So the diagnosis of Alzheimer's disease and Parkinson's disease and all of these other conditions were basically made on clinical symptoms, but the clinical symptoms were not specific and they were not sensitive. This really changed with the development of amyloid PET scanning, which allowed the measurement of amyloid in the brain and people who are alive. That happened about 15 years ago, and that has really broken the whole field wide open because if you have a lot of amyloid in your brain, you have Alzheimer's disease. As Robin has mentioned, Alzheimer's disease is amyloid leading to the spread of tau protein, which causes neurodegeneration. And after the development of amyloid PET scanning, then tau PET scanning was developed. And MRI measures neurodegeneration. So with amyloid PET -- tau, PET and MRI, we can measure the sequence of amyloid to tau to neurodegeneration. And all of these are now used in all the clinical trials that use clinically. And what -- and this has now also led to the blood test, which are really going to have a huge impact because they can be used for millions of people. So initially, the blood test were for measuring changes of amyloid in the brain, and they were validated using the amyloid PET scan. Then blood test came out measuring various species of tau in the blood. And now the blood test field is also just getting very exciting. There are various new platforms being developed, measuring a wide variety of proteins. So this is really just opening up the whole field of neurodegeneration in a very exciting way.

Great. Thanks. And I know that you've been closely involved in many of the trials that were run over the past probably decades. So I'm really keen to also hear your thoughts on how these technical developments have changed the way we run and execute clinical trials. And therefore, how it has helped to the successes we've seen over the past years and how it has also potentially likely contribute to a renewed interest. We -- I believe, see in AD drug development today. .

Well, all of these developments have had huge impact on clinical trials. More than 15 years ago, clinical trials only were measuring symptoms. Symptoms are obviously very important. What's most important to patients and their families is how they're progressing, how well they are doing, and we continue to have to measure things clinical measurements, activities of daily living. These are extremely important. But the ability to measure the actual disease process in the brain is extremely important because the treatments are aimed at a specific disease process. So all clinical trials use amyloid PET these days. Many clinical trials use a tau, PET some extent, all clinical trials are using MRI because MRI is important at a variety of stages. It's important that the inclusion stage to make sure that people don't have other significant disease. For example, you don't want somebody with a brain tumor or multiple sclerosis in an Alzheimer's disease trial. But they also measure side effects because these treatments that pull amyloid out of the brain are sometimes associated with what's called area, that is a swelling of the brain or bleeding in the brain, and those are sometimes serious side effects. So repeated MRI scans have to be done during the trials. And performing imaging over hundreds of various sites with different scanners, some are GE, some are same and some of our [Philips] some of the scanners are new, some of the scanners are old, gathering the data from various sites and various scanners and being able to get a high-quality longitudinal data that is harmonized is a very specific art, and IXICO really has developed is to a very high degree.

Great. Thanks, Mike. And -- so with that context, where do you see the field go next? So what is next in Alzheimer's? From a biomarker perspective but also from a truck development perspective, more generally, obviously, keeping in mind that we do have treatment now, where do we take it next.

Well, the next is also incredibly exciting. It's basically in a bunch of different buckets. The first is it's been shown that pulling amyloid out of the brain with monoclonal antibody slows progression, but number one, there are side effects and number two, the rate of progression -- the amount of progression slowing is significant, but we need to do better. So there's a lot of work going on just in amyloid removal and there are new antibodies using something called the brain shuttle, which gets them into the brain more quickly. They seem to be more effective at removing amyloid and they seem to be associated with less side effects. So there's going to be a whole bunch of clinical trials ongoing, starting right now. Roche is a leader in this, and there are other companies doing this. So that's one big area, just better amyloid removal. The second area is what I call prevention trials with amyloid removing bugs. The current studies that are approved are on people who have symptoms, people who have a memory problem who are progressing. They obviously need treatment. But the ideal thing is to find a way to prevent development of symptoms, because we know that about 20% to 30% of the population over the age of 65 has amyloid in the brain and they have no symptoms. But they are very high risk to develop symptoms. So those of you in the audience, just remember that about half of the population over age 90 has dementia from Alzheimer's disease, and that about 30% of people over 65 have amyloid in the brain, which puts them at very high risk. So both Lilly and Eisai are currently in major prevention trials where people who are clearly normal over the age of, I think, 55 or so who have amyloid in the brain are being treated with these monoclonal antibodies to pull amyloid out of their brain to see if that delays onset of mild cognitive impairment in dementia, there's a lot of hope that these are going to be successful. I think we have a reasonable expectation. But we have to wait to see the results of the trials. I just learned yesterday that Roche has also announced that they're going to go ahead and do a prevention trial with their brain shuttle thing. So that's amyloid. Then there are treatments that can tell which are very promising, and that's a very, very exciting area because it's in fact the tau protein that really does the damage. So that's the -- so there's the amyloid bucket, is the tau bucket. And now we have the GLP-1 agonist. And that's, I think, really hugely impactful. The GLP-1 agonist like Ozempic and Wegovy and Zepbound are certainly very effective of controlling diabetes that cause a lot of weight loss but people lose 20% -- obese people can lose up to 20% of their body weight if they're on these medications. It results in better control of hypertension. So there's basically all better control of diabetes are reduction of obesity, hypertension control. It just makes for better vascular health, and there's a lot of evidence that these improve brain health. There are studies already showing that people treated with these medications have less drugs and there appear to have less [dementia] Novo Nordisk has now completed a Phase III study in people with symptomatic Alzheimer's disease and the results of that will be announced very, very soon in the next few weeks. But even if those trial is negative, I think the real impact of the GLP-1 agonist is going to be prevention. That is people who are cognitively normal, who are diabetic, or who are obese. And just remember, in the United States, almost 50% of the adult population is obese. So these medications are going to be used on millions of people up until now, they have to be injected, but Lilly seems to have a good oral pill. And I think there's more than 100 companies developing GLP-1 agonist right now. So I think there's going to be huge numbers of clinical trials. And these are going to be focused on -- a lot of them are going to be focused on reducing or slowing the development of cerebral vascular disease. And this is an area where IXICO has really got a phenomenal, highly automated platform to quantify all the different ways that cerebrovascular disease affects the brain. So between amyloid and tau and the GLP-1 agonist, and then the work that's going on in Parkinson's and Huntington's and all these other neurodegenerative areas, this is a hugely exciting area for growth.

That's great. Thanks so much, Mike, for giving your perspective. I think we're coming up to time. Is there anything you'd like to add from your side, Mike, before we go into Q&A.

No, this is just a hugely exciting time. I see lots of new trials coming on. Everybody who comes through the meetings is very, very excited. AI is going to have a big impact on this. IXICO is really taking advantage of that. The -- this is just going to make our lives better.

Great. Thanks so much. I'll hand it back to James. .

Thanks, Mike. And I think you're staying on for a few minutes on for Q&A. So we do have a little bit of time now for Q&A if anyone has any immediate questions we'd like to ask. And then we have a break in about 10 minutes time, and then we're back at 3:35.

Chris here. So just, let's say, a couple of questions. Just one on science leadership. And obviously, you've got all the data that you're putting through. Is there anything that IXICO can do on its own that could possibly present some of that data as IXICO or is it all tied up into your clients' data sets and you're not really allowed to use that? Because obviously, IXICO publishing its own results and its data would obviously put your name out there. So is that an opportunity? Or are you completely locked out by your competitors? And then maybe just on the accelerated approvals in the Huntington disease, is a risk that those trials accelerate and, therefore, they are not doing the Phase IIIs. And so you actually by being able to produce the data that you do, you're blocking your Phase IIIs in a sense?

Good question. Robin first, and then Bram want probably add to that.

Yes. Thanks. I'll have a go at both. Thanks, Chris. So on the data side, we are publishing. I mean, you're right, the data that we produce as part of clinical trials is owned by the pharma company. So we're not typically publishing on those. We are sometimes in collaboration with pharma sponsors publishing on their results, but we also key part of our R&D strategy is the engagement in research consortia, like the one, we mentioned with GAP, Global Alzheimer's Platform, the Huntington's consortia and this is typically where we produce the scientific presentations that we provide. Second question on Huntington's disease accelerated approval. I think we would all be very happy to see those drugs coming to patients. And I think -- but to answer your questions directly, I think we've seen in Alzheimer's that having one accelerated approval doesn't mean everything else is stopping. So firstly, there's different mechanisms that may be suitable for different types of patients. What uniQure doing is a very -- is actually a very involved playing surgery for administration. So this is a very complicated way of administering the drug and what, for example, PTC, Novartis are developing in the Phase III, it's an oral pill. So there's different mechanisms that we will be testing and there's different ways of administration as well as they justify for other trials.

So maybe just to add, and especially as we've got Mike here as well, yes, we don't publish the data of our customers. It's their data, and it's their publications. Having said that, we can be co-hoisters or we can be part of it depending on whether biomarkers are really sort of a central theme also in those. Having said that, today, you see Mike for 15 minutes here talking a little bit about what's going on, but actually Robin and Mike are doing a lot of work together and will actually be together at clinical trials in Alzheimer's in a couple of weeks' time, as Mike said, in San Diego, which Mike is co-organizing where there will be work groups around this. And it is my expectation that Robin together with other leaders, industry leaders, so across companies, if you wish. And of course, with key opinion leaders like Mike, is going to then start to generate more insights, for example, around vascular and those, of course, can be published as well across sort of the various industry players.

A quick question just on the role of nonimage-based biomarkers. Mike referred to the increased use of blood test, for example. Do you see that as a potential threat in terms of IXICO's specialism in imaging, will that be displaced in any way by the use of blood tests? Or is it complementary?

Can I answer that question? And I think Mike might have an opinion on that while we still have them as well. I don't think so. And I think as soon as I entered the company, I also said, let's embrace this. And so we're validating those, and that's why we're so proud of being instrumental in Fujirebio coming with the first blood-based biomarker and now you see these orders rapidly coming to market as well. First of all, as you know, our current business model is not in the clinic. These products are being developed for the clinic. And I think as Mike actually alluded to it, they will give access to a whole group of patients that today does not have access to other diagnostic modalities or where it would just not be economically viable to start to put everyone in an MRI or PET scanner to at least early diagnosis. So I think I'm using a lot of words to say, I think it brings diagnosis potentially earlier in the disease, and I think that's a new market. And secondly, I think it's really sort of complementary to what imaging does. Keeping in mind also that our market is very much in that research space, where I do think blood-based biomarkers are probably going to start to become part of the protocols of some of these trials. I also do think that we're not entirely there yet. But I don't know, Mike, Robin, you guys are the experts in the room.

Yes. I think it's the complementary value we see. And I think we -- there's so much need for diagnosis that being able to align those measurements in the right way, it really opens up opportunity to be able to assess more subjects. And -- last but not least, of course, we're working with diagnostic companies in refining those biomarkers as well. So we can increasingly deploy them in clinic trials. I think one thing that Bram didn't touch on is the added value of imaging that we currently don't have in biomarkers, specifically from MRI, which, as Mike said, is a safety, key safety measurement that cannot be replicated from a blood test at the moment. We talked a lot about vasculature, specifically in the context of GLP-1s that are coming up. Again, this is something we're taking from an MRI, where there are currently no developed blood-based biomarkers. So I think there's a role for both, and we have embraced working with those companies early on, which I think puts us into a quite nice position now because it helps us on kind of like playing a role in this area where it's multimodal. We're basically looking at both, right? And building up expertise on how the to interact with each other is actually something that has helped quite a lot now working with those diagnostic companies to validate them. I don't know, Mike, anything.

Another way to answer the question is that what blood tests are going to do is they're going to just hugely expand the target population. In some circumstances, it may be that blood test would replace, for example, amyloid PET. There's still a lot of debate as to whether or not a blood test is good enough to replace an amyloid PET scan for inclusion. But one thing we know for certain, the blood tests are not good at measuring amyloid removal effectively. They don't -- the only way to know whether amyloid has been pulled out of the brain is to do an amyloid PET scan. So you need to have a longitudinal amyloid PET scan to show that the treatment is working. Blood tests so far are not very good at predicting the tau level in the brain. And certainly, the only way to measure the cerebrovascular vascular disease [Technical Difficulty] White Matter Disease, all of the things that happened from cerebrovascular disease that has to be done with MRI.

Mike, thank you very much for your comments, especially about the fact that over the last 15 years, there's been a huge advance in the way we are starting to understand brain disease. I was fortunate enough to work in Parkinson's with [Eli] Lilly in the '90s. And in those days, we call it which craft. We had no idea what was going on, I'm sure you remember. Looking to the future, we got these GLP-1 data coming out. I think it'd be really interesting to hear your and obviously talk to your peers on what you think the outcome of the GLP data will be on Alzheimer's, and how it will have or may have no impact on the amyloid and tau trials which are ongoing.

Well, that's -- nobody knows the answer to this question. But basically, what we all care about is reducing cognitive decline and dementia in the population. Now if you look at autopsy, if you look at the autopsy data probably 80% of the people that have dementia have Alzheimer's pathology in the brain. But they are very unusual if there's -- it's only Alzheimer's pathology. Usually when people have dementia, there's a mixed picture, which includes amyloid, includes tau but it also very commonly includes some element of cerebrovascular disease. We know that these GLP-1 agonists are good for brain health, there's no question that they're good for brain health, and they're going to reduce the number of strokes and so forth. Whether the GLP-1 agonists are going to slow the effect of amyloid accumulation or tau accumulation is very uncertain. But to me, I don't think that's really going to be necessary. I think they're going to be very impactful to really improve brain health, reduce the development of mild cognitive impairment and dementia in the population. And there's one other thing. Most of the work that's been done, most of the research that's been done on Alzheimer's disease has been done on highly educated, affluent people who have health insurance. And in that population, amyloid and tau clearly are the major causes of dementia. We have much less data on poor people on people with lower education because they don't volunteer for clinical research. It's very likely that cerebrovascular disease is a much bigger cause of mild cognitive impairment in dementia than we think because most of our studies haven't been done on the population that has poorly controlled hypertension, as more diabetes. The GLP-1 agonists are going to have be hugely impactful in that population. So there's -- but there's just going to be a lot of clinical trials done on this. This is a huge growth industry. And IXICO is perfectly situated for this especially because of this beautiful platform to measure cerebrovascular disease.

So thank you very much. I'm delighted now to introduce Johannes Streffer to you, who is SVP Global Clinical Development at Lundbeck. Johannes, can you hear me?

Yes, very well.

So Johannes has got a very strong academic background in both neurology and psychiatry. But he's also spent a long time in pharma at a very senior level, both at clinical and leadership levels, notably at J&J, a UCB and AC Immune, and what's interesting, actually, and hopefully, Johannes is going to touch on a little bit to this, throughout his entire career, he spent a lot of time dedicated to focusing on how artificial intelligence can play a role where data plays a role and where technology plays a role in further in drug development. And so on that note, I'm delighted to also welcome back Bram, who's going to have a fireside chat with Streffer -- sorry Johannes.

Johannes, are you dialing in from Copenhagen or are you dialing in from Germany?

Copenhagen.

Good. Well, welcome to London. I want to start, I think James already gave the introduction, right? But when we spoke a couple of days ago as we were preparing for this day, I think we sort of discovered or you actually uncovered. So I hope I'm not still in your thunder here, but how our organizations have some similarities as well. And I think that struck me right. So you said that we're both focused on CNS. Obviously, I've made it very clear to the audience today as well that we do feel being in CNS means being in very fertile ground, and it is sort of a very opportune time. And I think you said, well, that's very much what Lundbeck is about as well. And secondly, we are priding ourselves in having done that for 20 years. We're celebrating our 20 years anniversary. And I think you sort of said, well, we've been doing this for 70-plus years in the more than 100 years history of Lundbeck, so I think there's clear consistency. And then I think James already alluded to it and I will invite you to sort of chime in where you see fit. Obviously, we have an AI-driven platform. We pride ourselves in being born out of, but as you said, Lundbeck has always been embracing digital and AI very much as a cornerstone, and you can maybe allude to it, but I think quite a few people in the audience probably also read even the most recent news where there was strength in collaboration between Lundbeck and OpenAI. And so obviously, I invite you to comment on that if you see that fit. But maybe starting with the sort of more generic first question. Obviously, we're in the business of precision medicine. We've been saying today how that is very important in some of these big disease areas, but also in rare disease areas, obviously, something that you're very close to as well. So how important is precision medicine according to you indeed in CNS today? And then more specifically, also how does imaging fit in there?

Yes. First of all, thanks a lot for having me. And I think it's great to put a focus on neuroscience and precision medicine. When we look at neuroscience, and I think you spoke about your tenure in neuroscience, Lundbeck as well as committed to neuroscience. And then we have said that we stay in neuroscience have done that for a long time. There is a huge change. And I think this is really breaking a lot of things open. We do understand biology better. And while neuroscience, specifically large psychiatry indications have always been very strong on phenomena. And in true that is critical for patients, right? The symptoms, we now get more and more into understanding biology and understanding what the underlying pathophysiology for diseases. And that is fantastic for precision medicine, right? Because here again, now we can understand the disease and then go about it with very targeted mechanisms. That has, I think, helped to break the neuroscience arena open. And I think this is as well strengthening the focus in neuroscience. And here you come and play, it contrast to dermatology. They can do biopsies. Other organs are easy, accessible. The brain doesn't, right? So we have to be much more inventive in the sense of how we go about looking at our diseases. And this is where it's obviously great to see an organization being dedicated to that and specifically with the focus you're having on brain imaging, which makes things accessible to us, right? We have as neuroscientists the opportunity to see symptoms very easy, but unfortunately, to see pathology sometimes difficult. And then this is where we come together and I think where it is great to see your focus on neuroscience.

Great. Thank you. So maybe humming in for a moment on that relationship that we have. And obviously, James made that introduction already that you've got extensive experience. You've got extensive experience in different organizations. What has been your experience with IXICO so far? And is there anything you would like to call out?

No, obviously good question. Now what I -- and I think what as well where my path is with IXICO because was not only on clinical trials directly but as well on advancing the science, right? And I think this is where pharmaceutical industry and then as well our partners that help us to get, let's say, get it on the road, we have to go away from pure academic research, but driving science into clinical development. And I think that is where I've seen IXICO, very strong being academically driven, right, good understanding. And if you look at your website, you have very nice publications. But then as we make sure we take this understanding into clinical trials. And I think this is what we need. We need to understand how the science is then as well moving forward. And I think meeting IXICO was as well in endeavors like IMI consortia or where we are closed. You had Mike Weiner just here before me, and there is a reason for it, right? ADNI is one of the big endeavors that has moved the needle in terms of understanding. Neuroimaging was one critical part in that just being part of that community and helping us to shape the clinical trial environment to be upfront and to use the best site and the best technology to bring that in a clinical trial is critical. And this is not trivial in the sense that when we do clinical trials, we have to do it to a very high quality measure. We have to use standards that are reproducible. It's not just about public issue paper. It's about developing results that we can rely on and patients can rely on agencies can rely on. And I think bringing that together is critical for me and that is where we have to partner strongly on.

Well, thanks for bringing that up. I know if you were here when a question from the audience came up around publishing together or publishing the data where clearly, we made the comment that we don't publish the data of our clients because it's their trials, it's their data. But I think what you're alluding to as well is that it is sort of an a cross-industry collaboration, right, and that it goes above sort of that commercial relationship, if you wish that we have, of course, with our sponsors. And so -- thanks for bringing that up. Moving on...

It is important here is we are for instance, we are committed to make data publicly available. And I think this is a commitment that most pharma companies today share. So that meaning you can often look at baseline data. You can ask for data, you can work with the data. We work in consortia together. And this is -- was from -- is and was, for me, a critical point that we do science together. And science has to be transparent and public. So why I fully understand that, yes, and I hope everybody understands we cannot be fully transparent about our molecules early on. We have to understand it and that the data are primarily there then as well to support the development of the drug. We as well know that we are part of the scientific community, and we make data available as much as possible.

So maybe bridging down a little bit more to Lundbeck, right? And obviously, delighted to have you here as the Head of R&D. What are you excited about right? What's happening at Lundbeck, what is on the road map there? Again, I mean, I'm not sure if we have investors in Lundbeck here today. But what do our paths converge?

So first of all, important clarification. I'm Head of Global Clinical development, not R&D. So clinical development is fantastic, and that's a great role. I'm super happy to be here. Now what are we excited about? And I think you talked about the legacy in neuroscience. When we look at it today, we really believe that we want to build on our neuropsychiatry legacy. So this is still super important for us, and we are trying to move that forward. We now then as well have 2 other pillars, which we think are critical that is neurospecialty and neuro rare. What does that mean? We have a focused innovative strategy. So we really want to advance in the science. We want to use the science and advance in a focused way in these days are. When you look at our current ongoing Phase III programs, we have [indiscernible] in Phase III programs, which are targeting very specific indications where we need to demonstrate superior efficacy. Now when we, for instance, look at biomarkers and understanding then a disease like MSA neurodegeneration, we really have to bolster that with our biologic understanding. And that continues into a lot of our early development and research. So translational medicine is a strong focus for us, meaning we want to understand what are the biomarkers in there? How can we early derisk? One of the creators of our Head of R&D, Johan Luthman is early derisking. We know that neuroscience has been troubled with late-stage failures. And this is something we cannot afford. So what we have to do is we have to derisk early and then take these derisked molecules into late-stage programs. And derisking early has to be via translational medicine. So the early program where we understand the mechanism, the disease, how does the mechanism in the disease interplay that is super critical for us, do that well and then taken derisk asset into late stage development, and that is what we are committed to in Lundbeck. And in neuroscience, we need advanced biomarkers to be good at that.

Thank you. And also thanks for that correction. I think it's actually useful for the audience. Indeed, IXICO, of course, is very much active in the development part of the R&D section, if you wish, which is also why Johannes for us is the important stakeholder, for example, with Lundbeck -- there is actually a question which I think we'll be answering separately around what is the role of imaging discovery as well, right, preclinically. And there is a whole lot of debate which we could open as well, which we chose not to. I think another part which I'm hearing Johannes, is the importance of rare diseases in CNS and how I think you're very excited about the growth that you're seeing there as well because obviously, for this audience as well, we are talking a lot about Alzheimer's and Parkinson's because we do believe the time is now for those big areas. We do think that is also a commercial opportunity for us as a company. But I think what we're witnessing here as well is a company that is very deep into this rare disease space. And I think there's a lot of progress made as well. I don't know if you want to comment on that at all?

Yes. I think that is critical, right? And we -- when we talk about rare often, we do not say neuro rare, right, or the ultra rare, neuro rare but not ultra rare. And then for a neurologist, a lot of these rare diseases are often coming into your office, so the neurologist sees diseases like PSP, MSA in the day-to-day practice. But we don't -- we have yet not developed sufficient clinical solutions for these patients. You're working on Huntington's disease, spinocerebellar ataxia. These are diseases that are very important, high unmet need, well described but no solution yet there to really help these patents forward in the treatment of solutions at the breakpoints, something where we really need to move forward. And I think this is why we are committed to this space because we feel it's -- we see high unmet medical need, and we see well-defined patient populations. It is not that we say we only want to do something for selected fuel. That is absolutely not the case. What we say is we want to have a well-defined population. That is then going into the neuro rare sometimes it doesn't have to be neuro rare. We as well do neurospecialty when you look, for instance, into our migraine prevention. But the key thing, it has to be well defined. So we have to understand the mechanism, and that then puts us into these groups on diseases, where, again, I still remember in my neurology education, I always love to be in the neuro radiology because the neuroradiology were the ones that in a visit like way could tell me what this good block would not be. So when we look at a diagnostic way, you do not have that many tools. You have to -- a patient, you can examine up and down and neurologist love to do that for hours. And MRI gives you a relatively quick, very thorough look on that brain to tell you what it can be and what it cannot be. And that is very important for us, specifically as well there cannot be, right? So we want to treat the right patients. We don't want to treat patients that potentially have something completely different, but just by symptoms look where we sit.

Thank you for bringing that to life. I hope that actually does bring it to life also for the audience because we often show sort of pie charts with sort of the disease areas we did that again of the day, granted that but I think we pride ourselves very much in having actually that dominance in rare CNS as well. And I think as you hear, we actually believe there's a lot of growth there as well. And so maybe that is a segue to my last question, and I invite you, of course, Johannes, to make your own comments. But what does excite you in the space in the neurodegenerative space in general. And I don't know if you want to sort of sprinkle in there the comment that was made earlier around AI and digital as well, right?

So in truth, I would like to answer that in twofold. And maybe start on the digital and AI. Clinical development has a fantastic opportunity in AI because we are digitally enabled. And that has certain reasons. So quality and clinical development has been super high. I still remember when I was an investigator, we had paper CRF. We moved away from that for a long time. Patient data at the site is all digital. Everything we do digital. Every outcome measure is collected MRI has been digital from the get-go, right? You said digital native. There is no MRI with the digital analysis. And that means that our data lends themselves to all sorts of AI applications. And we have a visualization pathway. So I have to say, coming here to Lundbeck. I'm super excited how the team had already built that super strong foundation. Now we have a very strong commitment as well from our leadership team to make sure we use AI where it is used for us. We really see it as an enabler, a lot. There are areas where it is breaking out completely new ground. But it's as well in those areas where it will be a productivity measure. It will make us faster, more efficient. It will improve quality, and these things we will have to use. And there are tiny things like writing a report to us, bigger things like getting a file together or then in research where you might have seen our colleagues in research are using AI now as well as we have strong collaborations where it might go to a territory where we never could have been. So I think the whole digital and AI is super exciting, and we have to do it. I don't think there is any choice. This is just the way forward. What excites me in neuro rare and I think I started to talk about that. I did my neurology training in the '90s. And at that time, we still were very phenomenology driven. You had neuropathology, right? But in the clinic, a lot of phenomena. We have electrophysiology and then imaging came, but that now these better diagnostic measures have been coupled with a better biologic understanding. So the understanding of these diseases has moved fantastic ally. We now can differentiate them on the neuropathology on the biology. And that leads us now to the point where we can develop treatments. So we come from an area that is phenomenology. We added diagnostics, diagnostics like neuroimaging. And now we use neuroimaging as well for readouts and pharmacology, clinical pharmacology. And this is a fantastic era. I think the era of neuroscience, as said, is just because we can do things today that were -- we were not able to do early. That's why I think neuroscience development. Hopefully, we'll have a very strong goal because there is a huge unmet medical need. If you look at the morbidity visibility by neuro diseases at all. It's a huge factor for patients and a huge factor in the life science area. So lots of tasks, but fantastic opportunity.

Yes. Well, we'll end on that. I think you really bring to life very well. Also our understanding underlying biology is really what biomarkers is about. I think that's what Robin was describing, one for had to leave me had to catch a plane, but I think Johannes is very much sort of bringing that to life. Johannes, is there anything else you wanted to share today? And then I don't know if we have time for questions as well or -- okay. So we've got 5 more minutes million. I don't know Johannes, if you had anything else otherwise...

I think -- I tried to give you all my wisdom I don't know for a question in the room or online. I'm happy to answer.

We've got a question here.

Yes. So you talked about neuropsychiatry and obviously, looking at the symptoms but now starting to more understand the biology and the underlying disease. So maybe I'm a bit behind on this, but I wonder whether there's any options for imaging of the brain in neuropsych like the rise of the neurodegenerative area.

Not that I am aware of immediately. Now what we do understand and just at ECMP, neuroinflammation was front and center. So we do understand that inflammation is a huge part in neuropsychiatric diseases. This is something obviously we can image. We unfortunately still today can not image psychosis. We have functional MRI, functional MRI has been trades a little bit in clinical development. So this is one part that we have been using on advanced MRI and advanced MRI, I think that is good. But that's we can -- super good scientists can give you an image when you're speaking, right? And then they have the activation, right. We have not yet been able to translate that into clinical development, really, right? There are -- so we try to do it, but it's super difficult. And I think this would be then the psychiatric part of it more, and this is tricky. So in the traditional psychiatric diseases, mood disorders, bipolar, schizophrenia, it's much more difficult than in neurodegeneration. And I think there's a lot of work ahead.

And I promise Johannes, I didn't tell Chris to ask that question because I actually had that discussion with Johannes briefly and we said we were going to continue with over coffee because Robin spoke about Neuromelanin, which obviously we're positioning in Parkinson's disease, if you followed. We did a webinar a few months ago on Neuromelanin and did actually get some phone calls from pharma, which were more in that neuropsychiatric space, which excited me. But I think it's indeed something that requires further discussion and analysis.

Yes. And I agree with that, right? And it was kind of interesting even in discussion with experts. Unfortunately, the, let's say, neuropathology molecular structural pathology of psychiatric diseases has not revealed much. Out of these studies don't give a specific -- you know the neurotransmitter changes, and that has been successful, but that is not the strength of MRI. Neuromelanin could be really interesting, but we have to understand that, but.

Very good. I think we're going to conclude it here then. Thank you so much, Johannes, and we'll let you get back to your important work.

Thank you. Have a good day. Bye.

So we're coming towards the end, and we're going to conclude with a section which is a deeper dive on what the IXICO technology looks like and what the IXICO technology platform does. And I appreciate we've talked a lot about AI today. It can be quite a thorough concept. And so hopefully, what we're going to do now to demonstrate what this actually looks like and the utility it actually has when it comes to neurodegenerative diseases. So great pressure and introducing Mark Austin, who's our CTO.

Thank you, James. So as James said, I'm the CTO, I've been at IXICO for 17 years, and I have the pleasure to work on this technology platform over those 17 years. And I'm going to start today with some like [Andy]. So I've got the pleasure to show you what the platform looks like first, and then I'll step back and take you through how we get here. So what you're seeing here on the screen is our integrated viewer allows us to see the output of these AI algorithms. So this is launched directly from the platform. And so these algorithms, as Robin has showed you, we can look at volumetrics. You can look here, for example, this is a whole brain segmentation. And when I say segmentation, this is the calculating the volume by saying what is brain or what isn't brain. And this can be done manually. And we've got people at our company that can do is manually, but obviously, what's a lot better is if you can do automatically because that's then reducible and it is faster, and it is also more accurate. What you're seeing here is a multi-region segmentation. So here, we're able to define 140 -- more than 140 regions of the brain, which actually later is really useful not only to look at specific diseases, but also enable some of our advanced MRI and PET analysis. And as I think it was mentioned earlier today, what's really important is being able to measure changes over time of these regions. So we can see here that we're able to look at a specific region, but also see multiple sequences taken at different periods of time, and you can see the changes there we're able to measure those subtle changes, and that's what's really measuring that neurodegeneration in for example, Alzheimer's or Huntington's. And what we're looking at here then is a 4-dimensional scans, this advanced MRI, and I'm not going to go into a lot of detail on how this works, just to show that we can visualize these 4 dimensional data sets with their time series. So you see in a moment, we can overlay those segmentations that we've taken from the structural MRI on top of those advanced images, but we can also visualize the motion and the time series, which you'll see in a moment as we scroll through that time series there. So what looks like a video has actually time series looking at one specific slice of the brain. As I said, all launched from our platform. So to get to those insights, we have an end-to-end platform that really enables this. So I'm going to take you through this workflow step by step. At a high level, we're taking data from hospital sites, the MRI and PET images as well as some clinical data that's uploaded to our platform. We perform quality control. We have radiology readers. If you look at the data visually, we have our analysis pipeline. This is where AI algorithms and other image processing algorithms are analyzing the data, and then we get report outcomes that can go to our pharma biotech clients. So the really key to this whole process is making sure we get the right data in. So first of all, that's about getting the data uploaded from the sites, the hospital sites. So we have teams that train the sites in collecting data with the right protocol. And then we have a no installation platform, web-based platform that these sites can use to upload the data. So we make it as easy as possible for them to get the data to us, and we can do so remotely. So the training can be done remotely, and the sites cannot load the data without any installation. And at the site, it will anonymize the data, so we deal with patient privacy, and we can also make sure that they're selecting the right data and help them get the right data in. So once the data gets to us is that quality control step. So we then have teams that look visually at the data using those viewers that I showed you earlier. And also another view I'll show you later. So what we're trying to do is make sure that we got the right data, and it is with the right quality for us to be able to run our AI algorithms and image processing pipelines, but also sorts the right data, the right quality for our radiology readers to be able to look at the data and provide those other insights that Robin mentioned. And this allows us to guarantee that high accuracy and reproducibility. We also have a data query mechanism that means that if the data isn't right, we can get back to the site, communicate with them, potentially get a rescan, if that's possible, which means we can guarantee more patients get on to the study, but if not at least, we can feed back the issues to the future images are at suitable quality. And not everything we do is fully automated. So we have our pool of expert readers led by Professor Frederik Barkhof from UCL and BMC. So we provide a web-based platform for them to perform these radiology reads. And here, this is the medical grade and medical device certified viewer that we provide, again, web based on the platform. It has to be medical device certified because they're making supporting clinical decisions here, and it needs to have the tools that our radiologists expect to see on their imaging platforms available to them so that they can look at the images correctly. They can look at image across time points and they can identify those clinical safety findings, possible drug side effects, but also support that eligibility process to make sure we're getting the right subjects onto these studies and allows the radiologists to perform these reads also anywhere any time because they can access the platform directly online. And this is critical as these radiologists we work with are often thought leaders, they'll often be at conferences or they'll be working in multiple hospitals. They can access it from anywhere. So as well as those manual reads, we obviously have our automated and AI pipelines. And this is obviously the perhaps most exciting thing that we do and those images that I showed you earlier will come through various analysis pipelines that are integrated directly into our platform. So we have a very flexible workflow engine, which allows us to integrate these pipelines, integrate Endpoint QC visual review of the data. And what it allows us to do is really turn that innovation from Robin's team, the science team into products that we can deploy in clinical trials as Johannes was saying. And that's really what the platform does really well. And obviously, these results will come out and be transferred in reports to the sponsors to our pharma sponsors. And that's really why they're paying us the millions of dollars to produce these results. So just to look at a high level at some of these different types of imaging appoint. And Robin, obviously touched on some of the exciting new technologies as we a little bit on what we've done in the past as well, as I mentioned, volumetric MRI is about measuring neurodegeneration. So by being able to comment these regions in the brain, we can help the pharma sponsors really track those disease-modifying drug effects. But also these segmentations, as I said, will help us to drive our advanced MRI and PET pipelines by creating a patient-specific atlas. So we can see for each subject, where the individual reasons of the brain are, which means when we're accessing for example, white matter integrity or brain network activity with advanced MRI to detect subtle changes, we can do so in a regional sense. And again, for PET, we're able to visualize those amyloid and tau proteins that Mike was talking about, so that we can monitor disease biology, but also monitor the effect of the drug. Is it clearing out those proteins in Alzheimer's, for example. And so this platform has been built and engineered for scale. So by building this flexible architecture, we've been able to integrate those bespoke workflows that we need to deliver our end points, so we can integrate both AI and analysis, those automated analysis tools. It also allows us to integrate third-party pipelines as well, and we have done that, and we'll be able to continue to do that. But this gives us a great platform then to be able to extend. And across the Board, we have regulatory compliance is a key component in this system. So this whole process that ensures that regulatory compliance and also my security. And here, I've put in my cheesy AI image for the day. So this is representing and the fact that this flexible platform and the agility that we have through our agile development processes and the extensibility of that platform empowered by both the AI that we use as a business, but also the new advances in AI enabling our accelerated development. We're able to, as a small U.K. innovator and play a big part in global scale in precision health care. Here we go. So we've mentioned AI a lot today. And so I just want to stop on this slide for a little bit. I'm talking about the history of AI and then how IXICO use that AI and the development of AI over time in the best way for our business. So artificial intelligence has been around for a long time. There's been a lot of buzz about it recently, but it's been around 50s, machine learning, which is a critical type of AI for IXICO, is about being able to learn from data. And that's really where IXICO came as a foundation. So we've built our technology around that ability to learn from data and develop predictions or calculate volumes. But more recently in around -- from around 2012 onwards, that machine learning developed into deep learning, so much larger neural networks, which really drove huge accelerations in improving the way that you can recognize patterns in data and analyze images. And so that really drove the development of our more accurate IXICO AI segmentations being able to create extremely accurate and very fast segmentations, as well as driving some of our other pipelines. So we took that on board almost immediately and made that part of our platform. And more recently, with the onset generative AI, large language models, OpenAI and their competitors, this is starting to make a difference for us as well. Initially, a little bit like, as Johannes said, in really just scaling and being able to make the business more efficient. But with the onset of Agentic AI as well, we're seeing huge advances in the development pace that we're able to achieve with these advanced tools. So Agentic AI is about taking those large language models and the intelligence that comes from that. But then allowing access to tools and giving it sort of goal-directed targets. So with the ability that it has a generate code that can hugely speed up your development and capabilities and allow us relatively small business to develop huge advances in our technology platform. So the future for us looks like taking our existing foundation and thinking about how that allows us to integrate and partner but then continuing to work with both deep learning algorithms where sometimes that the right technology to advance our AI imaging but also making the best use of generative AI and Agentic AI to increase our development efficiency and be able to deliver these new opportunities around trial automation, new analysis endpoints and clinical decision support. So to finish, I just want to sort of visualize that for you by looking at this report that we generated that could be launched from our platform. So this is a report that takes in blood-based biomarker data, imaging data, both PET and MRI and uses AI to generate differential diagnostics. So this shows how by partnering and using our AI platform, we can -- again. We can provide insights, precision insights through our platform. That's it. Thank you.

Thank you, Mark. So that concludes sort of the formal presentations for today. I would invite anyone else that has any questions, please, to go ahead and ask them. We do have a couple of online ones to that I'd like to get to. But if anyone in the audience have any further questions.

Very interesting presentations. I think one thing that would be helpful to touch on from my point of view is where IXICO sits within its competitive landscape. I'd like to understand a little bit about of the all of the benefits you discussed today, which are particularly USPs for your company over competition? And also obviously, you're not alone in driving innovation. And are there any kind of innovations that are on your radar that you're looking to make sure you have in order to keep up with competitors or you see competitors taking a lead on potentially within your core areas of business or in adjacencies that may prove to be complementary. That would be, I think, very interesting.

Let me maybe start. And obviously, I invite my colleagues to chime in Grant and Mark. It depends a little bit on what you consider competition. I think until a few years ago, and as you know, I've been with the company since a year. People might have set IXICO is an MRI company. They're very specialized in analyzing MRI images. And so you -- there were others such as Invicro, which is now perceptive, which are very well known for PET analysis, but also PET trade through management for clinical trials. We've caught up to that. I think today, no one is saying that we are an MRI company, we are an imaging a CNS imaging analytics company. And so I think that sort of basic catch-up has happened. And I think I can truly say that today, as a company, as an iCRO, we're very much at par, if not better, with some of these big competitors, which would be, in our world, mainly Perceptive and Clario, which are massive companies, right? I mean, Clario, we talked about it already. Clario does more than imaging. Otherwise, they would not be doing [$1.2 billion] in top line. which brings me, I think, to the second point, which is AI and how do we utilize data and AI. And are we at the forefront there with our platform. I'm hoping that today we've shown that, that is the case, very specifically in CNS. Of course, we've picked a few battles. And in addition, with big battles of application, which is, for example, vascular. That's why we've -- you've heard us talk about that, because if we try to make a difference in too many areas, then we do actually become like a Clario just at subscale. And so the choice has been to go deep into certain areas, use a platform, I think, as Mark hopefully eloquently said, that can really do big things for a small company that we are to be very competitive, especially in that CNS and in that neurodegenerative space. I don't know, Mark or Grant, if you want to add in. And if that answers your question.

Maybe I think possibly, what I would say to that is because of the fact that we specialize so much in CNS. And because we've really made this effort, and I think if Robin was here, he would definitely present this to really identify what are those really key areas that differentiate us from -- potentially from our competitors in these key therapeutic indications for us. And we're really focused on investment on that. We are making sure that we are leading, as we say, in that scientific field. So I think whilst we have some competitors who are much bigger than us in scale, their focus is much more broad brush and not as focused as is. And I think that's what gives us that edge.

Maybe to bring that to life, sorry, if we're belaboring it a lot, but you may have -- you may remember, actually, when I came to your offices also for the capital raise that we said we're making some choices, and we're also not choosing to go into the other areas. MS is a big area where today, we're not necessarily positioning ourselves deeply even if we have MS trials that we're supporting and our platform is being utilized, there was a specialized MS company. It has been acquired over the past year by Clario, NeuroRx, Canadian company acquired by Clario. There's another smaller company, unfortunately, which has announced publicly that it is going to stop business in Switzerland. Again, these are opportunities that present new business to us. But I think it sort of reinforces how if we had tried to be good in MS and Alzheimer's and Parkinson's in addition to that entire rare disease space, then I think we would sort of start to spread ourselves too thin. Obviously, the question that I will be asking the group, in addition to partnering the technology with some of these big data groups with some CROs is what are some of the imaging areas that we do want to continue to invest in because, obviously, the road map that I presented for the capital raise was a 12- to 24-month road map, and we don't want to fall off a cliff. And so I do think that we need to have a discussion, for example around how can we go deeper into MS. But obviously, that does then come off the basis of traction that we have generated first in Alzheimer's and Parkinson's. So sorry, that was a long-winded answer.

I was just curious in terms of other instances where there are different reads from, say, the human analysis and the AI analysis and especially as AI becomes more advanced, what would be done to resolve these issues if there was differences?

It's probably best for Robin to answer, I'm happy to take it for now. I think at the moment, we don't tend to if we're running both human and AI analysis on the study, one of them will be that primary endpoint and then the analysis to any differences between them would then come afterwards as a sort of secondary analysis to review either improve the quality of the automated analysis or investigate what those differences happening. There are cases where we have actually used image analysis pipelines as part of a read there supporting the read providing data, but that's usually supplementary. So it's giving that additional information to the reader to help them make their decision. And so they don't tend to sort of compete with each other. That's not how studies would be set up.

Maybe I can answer as well. We've also seen for a long period of time that one manual read might differ from someone else's manual read. In fact, that same manual read might be different in the morning to the afternoon with the same person. And that's why AI really comes in because AI standardizes and gives that consistency. So actually, it's complementing the 2, which is really what IXICO can do and obviously this as well, but really benefits clinical trials or even indeed clinic itself. .

Like ask 2 questions. One, just developing the Clario use and your sort of initial reaction to that news beyond perhaps the 7x revenue multiple. And what was your immediate reaction is what you think it means for IXICO it an opportunity? Or is it potentially more of a threat? And my second question is sort of a slight different one, which is in the first section of your presentation, Bram, you talked about going beyond potentially the fee-for-service type revenue opportunities. When do you think the sort of timing of those in terms of partnerships and so on, will be most likely?

The questions are actually linked, I would say. So it's a nice segue. My first reaction was an e-mail to my colleague saying 7x more -- but -- if you look at Clario, as I mentioned, it is much more than an imaging company. So we do encounter them on the market the whole time because they are an excellent imaging company, and it needs to be set, but they obviously are not specialized in CNS and their biggest business is in oncology, but they do good CNS work as well. What Clario has been doing rapidly is consolidating not only imaging but also eCOA, so cognitive data, digitalization. We've got a sister company that you're well aware of here in Cambridge that is doing a similar type of business. They do a lot of other biomarker and clinical trial work. And now, of course, PPD, which is really that part of Thermo Fisher that is mainly interested in Clario. So it's about consolidation. So I think it's good news. I think it's good news for you guys because I do believe all eyes have been on IXICO since a while, but will be even more on IXICO. But obviously, as I've always said, I feel like we're in a business now of creating value before we have further discussions there. And that brings me to the second question, which is -- we can do the same from a technology perspective. I think you heard Mark say that we can maybe even do more, especially in CNS. But we can't with who we are and where we are, put armies of people to sort of commercially scale that up. So we need to partner. And those discussions are ongoing. You haven't seen much of James, but you will see more of James in the future. We are having these discussions as we speak. I don't think they're ready for prime time. But it's clear that commercial scaling of our platform and being part of that multimodality cognition, imaging, blood-based has to come through bigger partners where we think we can sort of almost plug in our platform into their ecosystem. And that will not be fee-for-service. That will be that other revenue model, I think.

One for Mark. Obviously, IXICO is dependent on the images that are supplied from the MRI machines and the PET scans. So are you seeing any innovation in that or free use of systems in terms of the imaging that's coming through and development the techniques that you get in scanned? And is there anything there that's coming through that might be of interest for IXICO?

I'm not aware of anything myself, it would probably be Robin, that would be better to answer that. But at the moment, I think the advances are not in the scanner technology so much as those techniques like neuromelanin and those other more advanced techniques that are coming through that we're obviously taking a lead in developing.

Just going back to the point about the competition. As I understand it within HD, there were very few trials and you guys have really captured that market. They're sort of in the mid-teens, 13, 18 trials going on globally, whereas in Parkinson's and Alzheimer's, there's 268 we heard today. So I mean, if you get even a small part of that market, that's a huge opportunity, let alone worrying about MS or any other type of inventory?

Absolutely. We actually have 17 on our radar, and it's growing because obviously, as soon as you see that FDA is now starting to talk about fast track and I think someone asked the question, "Oh, maybe you might miss out a Phase III because they may get approval after Phase II, but that still will create a lot of excitement in the industry. I think what I've learned over the past year myself personally is we should not rest on our laurels. We do need to keep investing in Huntington's disease as well. We do need to make sure that we -- Robin said it, we are managing a consortium together with the Huntington's association based in New York. We need to make sure that we stay at the forefront that we make sure that any Huntington company becomes part of that consortium because as soon as they're part of that consortium, they're going to find their way to IXICO as well, right? So hopefully, I think your question was a bit of a comment more than a question. But my message clearly is we can't rest on our laurels, and we do need to continue also to innovate in the Huntington space because, indeed, today, we believe we've got 80%, 8-0% of that market.

So we have one other question we probably -- we did have quite a few online questions, but actually, the audience in the room is pose quite a few of those questions. So the last one I just wanted to address probably the you Bram and Grant is how do you see the pipeline of revenue and new contract momentum building? And what options do you have to accelerate this through your sales strategy? I think we had slides on this, but I'm happy to go back to them, but do you want to answer or should I get back on your slide?

No, no, no. I'll try to answer it without slides, and then you can chime in. How do I see the momentum? The momentum is there very much in terms of the discussions we're having with new partners and the RFPs that are coming in and the proposals that we can prepare. Sales cycles are long. So I would have wanted to have a bigger order book by now. I came on board 12 months ago. But we clearly now have a pipeline. I think Grant actually has showed that funnel, right? So when he says in Alzheimer's disease, we think there's 40 million in business to be accessed, of which then sort of 80% is readily available for us to go into. We know which programs they are. We've done really when you set an analysis, we know which sponsors that are, we know which programs that are, and we now have an active commercial team together with the medical and innovation team that approaches those companies and that actually now tries to get in -- especially in those Phase I and Phase II trials. So I think we've done the pipeline building. You've seen that we've also got a platform now to make a difference. You've heard one client at least that is very excited. You've heard a key opinion leader that is also clearly saying you've probably made the right bet by going into vascular, and so that is something that excites me a lot now. Obviously, what I want now is that I can come with that order book and with some of these deals in the next coming quarters.

Yes. I think -- I mean, the only thing I'd perhaps add to that is there's really -- there's 2 elements to this, which is, one, investments that we've made over the last 12 months have been the right investments. And are they going to put us in a better position to win trials. And the other is the market itself. And is the market warming up and are we seeing more trials coming through. And I think we are there was an interesting report and webinar given by GlobalData recently, which seem to indicate that there are more trials starting in the market. We're seeing that as well after what has been a bit of a challenging time for the market over the last couple of years. We're seeing that start to come through. And then it's these investments we're making -- are they really going to deliver and we're very confident they are. And I think just an example that I have very much in my mind is that we announced contract win alongside our trading updates just after the end of our financial year. That was a contract that we went for and we regarded ourselves as perhaps being the third place company for that. And perhaps in previous days, we wouldn't have won it. We won that purely off the basis in a little bit further way than Robin and Bram. But from really from the basis of the discussion of what we've developed in the pipelines we developed and the fact that those pipelines can be utilized in a way that, that particular organization hadn't envisaged. And that took us from third place to winning that contract. And that was a really big moment for I mean, not necessarily because of the value of the contract. But because what that showed these investments in these areas we decide to invest in potentially are giving us an opportunity that we didn't previously have. So hopefully that helps answer that question.

Well, thank you all for coming, and thank you to the presentation team. It's been really fascinating to hear from those at the forefront of science in this important field, especially in so many neurological diseases still lack effective treatments. A special thanks to Johannes for showing us how IXICO is supporting Lundbeck in their clinical programs, shareholders and investors is invaluable to see how this great technology is being applied to advanced development of life-changing treatments that have the potential to benefit patients worldwide. Cavendish has been proud to work with IXICO since April 2019, helping to shape its story, support its growth and raise the capital needed to advance technology and diversify its markets. From the very beginning, it was clear that IXICO possessed world-class technology, providing essential services to both big pharma and biotech companies and consistently punching well above its weight in the market. Working side by side, we've helped the company amplify its achievements and navigate the inevitable challenges that come with being a growth company. And there has been a great deal to celebrate. The development of exciting new biomarkers that will play a pivotal role in tackling some of the most serious neurological diseases, including Huntington's, Alzheimer's and Parkinson's as well as the company's strategic partnerships with the global Alzheimer's platform foundation, giving access to valuable data from the Bio-Hermes studies. It's also clear that IXICO's work is making a real difference, by providing imaging analysis for uniQure, IXICO contributed in a small but very meaningful way to uniQure's recent breakthrough in the treatment of Huntington's disease, a devastating and previously untreatable condition. Of course, as with any growth companies, there have been setbacks along the way. It is a testament to Grant and Bram that they foster such a strong center of integrity and trust in the company, ensuring investors confidence that any challenges will be faced head on and that IXICO will emerge stronger each time. And finally, I'd like to send my congratulations to Bram on his first year as CEO. Take it from me, stepping into the leadership of a small-cap company is never easy, but Bram has done a superb job, supported by a talented and dedicated team in driving IXICO forward. Under his leadership, the company has advanced its world-class platform, won new business in new markets and continue to unlock its full potential. Thank you.

Well, thank you, Julian. And I still remember when I had my first week in the job, which I think I was already in this building then, talking to Giles and Giles said, well, this is baptism by fire because we immediately hit the road, right? And I think by the time I had come on board, I really do the names of a few of the key shareholders, some are here in the room. So I want to end on a personal note. I think we've done an excellent job staying on time. So we'll try to let you leave on time, indeed. First of all, thank you, James, for organizing today because I think I enjoyed it, and I hope that it was valuable also for the audience also remotely. So thank you for everyone who's made this happen also from a technology perspective and of course, for Cavendish for having us. And of course, from my team, I think from my team, it has been a great way also to sort of solidify what we've been doing, which during what has been a very intense past year, which I think has been very successful. So I want to end on -- hopefully, today, you have seen that we have turned the page of that company -- of the company -- we are an iCRO that is back to growth that will get to double-digit top line and profitability within the time lines that we have set out. And of course, there's always the hope that we can do this even faster. And that is through science, through some of the choices which we've made. They were beds only 12 months ago, I would say, at least vascular definitely, and they are realities now, and you've heard that confirmed by some of the people who know better than definitely me, I would say. But I think it's the vision of Robin, which clearly has informed that as well. But then there is that next chapter. We alluded to it a little bit. We spoke about it a little bit, but you will hear more about it. And that's why I joined the company, right? I joined the company for the platform that Mark has been building that I think with the vision of Grant has been shaped because despite the fact that we had revenues going down, a company that was profitable, no longer being profitable, investments, millions of investments were made with your support, of course, in that platform. If that hadn't happened, frankly, I wouldn't be standing here because I would be, okay, this is a company that is not going to make it. So that investment happened. The platform is there. We equipped it with the right algorithms because otherwise, you would not have had that impact what we're seeing now. My task with the team is now in the next 12 months to show you that, indeed, that pipeline in that order book is translating into the top line. And then I want to have that conversation again with you about what is next, if you remember, that purple line, which I kind of cartons put on a slide. So with that, thanks for being with us for 2.5 hours today, and I look forward to meeting you...