Thalia Therapeutics Plc (THAT) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and welcome to the N4 Pharma plc Investor Presentation. [Operator Instructions] The company might not be in a position to answer every questions received during the meeting itself, however the company can review all questions submitted today, and we'll publish those responses where it is appropriate to do so on the Investor Meet company platform. Before we begin, we would just like to submit the following poll. And if you could give that your kind attention, I'm sure the company would be most grateful. And I would now like to hand you over to the team from N4 Pharma plc. Nigel, good morning, sir.

Good morning, Jake, and thank you very much for the introduction. And thank you, everybody, for joining us today. My name is Nigel Theobald. I'm the Chief Executive of N4 Pharma. And we're also joined today by Alastair Smith, who is recently appointed Non-Executive Director, and Alastair will give you a bit more of a background on himself as we go through. So without further ado, I'll just walk through our investor presentation. I just want to give you, first off, a little bit of an overview of N4. So we see ourselves as a really exciting investment opportunity in what is a very differentiated and hugely successful and growing biotech market. And we see significant upside potential for us as a business based on where we are today with our current share price. And what we're doing is we are developing a proprietary gene delivery platform, which we call Nuvec. And the role of the platform is to enable nucleic acid therapies, RNA therapies, particularly you heard of, for things like cancer and other diseases. So you can deliver those molecules into the body safely and effectively. And the lead program that we are working on is something we call N4 101. And what that is, is a dual targeted orally delivered RNA therapeutic, and it's designed for improving the lives of patients with a disease called inflammatory bowel disease, which is a very life-changing condition and causes lots of side effects. So the reason we're developing this product is that, it also showcases the best parts of our Nuvec platform. So as we take that forward into clinic, we're also doing the work on our basic platform to showcase how good it is. And just a bit of a background on us. We were established in 2014. And obviously, we are listed on the stock market, and we were listed back in 2017. So that's a bit of an overview of the business. And I'll just give you a brief rundown of the Board. So I'm the founder. I've got over 25 years' experience in building businesses from start-up, primarily in Academia through to exit. And I used to work as Head of Medicines back in Boots The Chemist. So I bring a sort of consumer health focus towards the biotech field. Luke Cairns is our Corporate Affairs Director. He's got a lot of background working as a nominated adviser in Northland Capital Partners, stockbroking firm. So he brings a strong corporate element to the Board. Chris Britten is our Non-Executive Chair. Chris has got significant business development experience working across a large number of different players. He's been Global Head of M&A at Sandoz, a Business Development Head at Sanofi, Pasteur. He just brings a really strong corporate and commercial overview to the business. We have also recently appointed Dr. Mike Palfreyman. He is U.S.-based, and he's got a lot of experience working in the U.S., both with major pharmaceutical companies. He was actually responsible for the drug, Allegra, you might know as a hay fever product. And also, he's taken several biotech companies from start-up through to exit. And last but not least, I'll just hand you over to Alastair, who can give you a brief overview. So Alastair just recently joined us as a Non-Executive Director. Alastair?

Thanks, Nigel. Well, I guess many people will know me from Avacta Group, which is a company I founded and ran a step back last year. I'm a scientist by training, obviously, with a very strong commercial bench. And since I stepped out from Avacta, I mean, just to give people a feeling for why I think N4 Pharma is an exciting opportunity. I don't want to preempt the entire presentation, but just to give you some brief thoughts. I've been looking for companies with strong technology, open, honest management teams that are undervalued. And as we're going to talk through in the presentation, N4 Pharma is addressing a very rapidly growing market, the market of RNA therapeutics, as Nigel said. But that market faces some really significant challenges in delivering the drugs to the right cells, to the right tissues. And N4 Pharma's Nuvec platform, which we'll talk you through, has the potential to revolutionize that process of gene delivery by solving those issues associated with manufacturing and targeted delivery to the right cells. And as Nigel said, in addition to that, valuable platform, N4 also has the potential to develop its own RNA therapies to really drive longer-term value, and those therapies will be differentiated by the Nuvec platform. So I really don't believe that the potential of the Nuvec platform is anywhere near reflected in N4's share price. And I think, there's significant upside for shareholders from where we are now. So it's an exciting opportunity, and I'm very pleased to be involved.

Excellent. Thank you, Alastair. Thank you for that, and we're really glad to have you on board as well. So as Alastair said, we're working in -- what I say is a proven business model for platform companies. So the RNA therapeutics market itself is growing rapidly. It's looking to -- it will be over $18 billion by 2028. p. But as Alastair said, it does face significant issues in getting the right drugs and delivering them to the right tissues in the body, getting them taken up by the right cells. And that's something that everybody is focused on. So everybody knows they need good delivery systems in order to make the RNA therapeutics effective and reach those sorts of targets. And we do have the potential to revolutionize gene therapy. We have solved significant challenges of how to manufacture simply and easily in our system, how we can target it to the specific cells. And it's very, very good at delivering RNA therapeutics. Messenger RNA, siRNA are the main two that we are looking on. And as we said earlier, what we're doing is, we're developing our own product towards the clinic, and that product is for inflammatory bowel disease. And what that product does is, it is not only clinically effective, what we hope it will be, we will demonstrate that, but it showcases the key benefits of the platform. We'll talk about the ease of manufacturing, the ability to target, the multiple loading that we can get on. So we'll talk through each of these benefits. But each of those benefits is showcased in this one product. So it's also promoting the platform itself. So what we're really committed to do is, is build the data set to drive our platform, because it's only through having good data that we're going to get partnering and licensing deals in the near term whilst we're then progressing our own products towards clinic to significantly increase the value above and beyond those near-term license deals. So we're well positioned both to deliver short-term and long-term increases in shareholder value from where we are today. Through an ongoing platform development and licensing of the Nuvec platform, but also developing ultimately our own pipeline of RNA therapeutics. And as I said, this is a proven model for platform companies. So I just wanted to give you a bit of an example here. There are five companies here. And I won't go through them all in detail. But what is interesting, each one of these companies started out as just a platform company. So they had their own platform similar to something like to Nuvec, called Aro Biotherapeutics. They have a platform based on proteins to deliver compounds. And they recently raised over $41 million at a $400 million valuation. And they only have three products in early-stage development. No products on the market, but they're going through the clinical phases. Arrowhead is another very good example. They have an siRNA platform that is able to target specific tissues. And what you'll see from our discussion later is, that's exactly what we have. We have a platform that can target specific tissues. We do other things as well, but it delivers siRNA effectively. And they now have a market cap of over $3 billion. And look at Dicerna, they've got a platform based on our GalNAc technology. DTx have got a platform based on fatty acids. So each of these companies have taken a platform, showcase their platform, but then ultimately develop their own therapeutic products, which have given some really large valuations. And that's where we want to get to, but we want to get there within the means that we have. So it's a big ask going from $2 million to $2 billion, but this is -- this technology has the potential to do that. So we're just going to give you a bit more of an overview about how we're going to actually do that now. So I'm just going to hand over to Alastair for a couple of slides, just to talk you through a little bit more about the Nuvec system and its benefits. Over to you, Alastair.

Thanks, Nigel. Yes. So just to reiterate the points made earlier, RNA therapeutics, as Nigel said, is a very large market, growing very rapidly, a lot of commercial -- I mean, a huge amount of commercial interest, but serious challenges related to the delivery of these relatively fragile RNA molecules. And the methods that are used are typically based on virus or lipid nanoparticles. Now, Nuvec doesn't rely on the same viral or lipid technology. It's a silica-based nanoparticle, as you can see from the image there, it has a rough surface, a spiky surface, if you like. And it is that spiky surface that gives it the ability to capture with a little bit of chemistry done to the surface to capture RNA or DNA and protect that and deliver it. And that's really the basis of why I think N4 Pharma has a very bright future. So, I mean, just to talk through the main key benefits. There's other things we can talk about, but the main key benefits are shown here on this slide. So the first one is the ability to load more than one RNA therapy into the particle, in a controllable way. And I think, that's the important thing. So being able to, for example, control the ratio of the two different RNAs that you put into the particle. And that is extremely difficult to do with other platforms. So the first benefit is we can do dual loading or even more actually, but realistically, the focus is on dual loading, so you can deliver -- you can guarantee you're delivering two therapies, complementary therapies absolutely into the same cell, which you can't do, of course, if you just make a mixture of two medicines. The second key benefit is endowed by that spiky structure, that rough surface. And it's rough on a nanometer scale, but that roughness is what allows you to capture and protect the RNA. And that protects the RNA from breakdown by enzymes and also from changes, extremes in pH. But that's extremely important, because RNA, as I said, relatively fragile, very easily broken down in the bloodstream, for example. And the ability to protect the RNA in the way that we can with Nuvec facilitates oral delivery. Now that is, I'll say, impossible. I'm sure there are approaches that you could take, but it's absolutely not straightforward with any of the other viral or lipid approaches. And of course, oral delivery opens up a whole range of potential indications for treatment, for topical treatment, i.e., treatment of the gut or potentially, and this is -- we've not achieved this yet, potentially giving an oral delivery for a systemic exposure, which would be an enormous advantage. Then in terms of targeting, Nigel has mentioned a couple of times, the need, the desire to target treatments to specific tissue rather than relying on a non-selective uptake by an organ such as the liver. Really, you want to be able to target your RNA therapy to a particular cell, a particular tissue type. And that is relatively easy to do. The chemistry of the surface of these particles allows you to attach ligands as we call them, that can bind to and target certain specific cell receptors. In terms of -- none of those benefits, of course, would be of any real use if it was horrifically difficult to manufacture or egregiously expensive, and that's not the case. The manufacturing process is very straightforward and cost effective. It is very straightforward to get the RNA onto the particles literally by soaking the particles in the solution of the RNA of interest. The particles are stable at room temperature, which means you can transport them and store them very straightforwardly. So from a practical perspective, not only does this platform have some real key biological benefits in targeting multiple payloads, payload protection or delivery, but it's straightforward to manufacture as well. Next slide, please, Nigel. So these types of comparison tables are very binary. They are ticking one box and no ticking another box. That doesn't really deal with the nuance of course. But let's use this to at least look at what -- how Nuvec sits in comparison with the standard methods of delivery that are available today. And as Nigel mentioned, there are other companies working on methods to deliver RNA and DNA therapeutics to get around exactly the same challenges that we've already solved. But taking this table for face value, first of all, interchangeable payload, can we deliver RNA, mRNA, siRNA, DNA? Yes, all of those can be delivered. And indeed, they can with the viral and the lipid platform. So that's something that all platforms have in common. Tissue targeting, we've spoken about. That is difficult to achieve with lipid or viral. Not impossible, but it makes the manufacturing even more complex. That is facile with the Nuvec platform. Cytotoxicity, we haven't mentioned that yet. Clearly, again, like manufacturing, if these particles were significantly toxic in any way, then that would be a major issue. And we're not going to show data today, but there is data showing that, the sort of concentrations that we want to use these particles are, they have no significant cytotoxicity. So that's obviously a major tick in the box. And certainly, viral systems do have issues with toxicity, significant issues with toxicity. Multiple payloads. We talked about it. Can you controllably with a known ratio load more than RNA into the delivery platform? Very straightforward in Nuvec, very difficult to do with the other platforms. You end up with empty particles, you end up particles with 1N, particles with 2N. It's not a controllable process, not straightforwardly anyway. Non-viral really speaks to the cytotoxicity point that we made earlier. And clearly, our platform and lipid platforms don't have that potential toxicity risk. IP, Nigel will mention IP, I'm sure. The Nuvec platform is well protected by granted patents in all the major territories. So there is a -- and of course, it's proprietary to N4. So it's a very simple, clean IP landscape with no stacked royalties. It belongs to N4. So that's a very straightforward IP position. I guess just being completely open and frank, it's a new platform, which is why we have to build out the data set to really demonstrate with robust data, these key benefits that we've talked about. There is already data, of course. But building that data set, so you can answer all the questions a potential partner might have will take a little time. And of course, viral vectors and lipids have been around for many years, and there are approved therapies using those platforms. So Nuvec is earlier in its development. Oral delivery, although it's last in this table. As I mentioned on the previous slide, very difficult, and I'll say not possible. I'm sure someone will come back and correct me, but I don't believe it's possible with other platforms such as the viral particles and lipids. But N4 101, as Nigel mentioned and we'll talk about on the next slide, is an orally delivered treatment for inflammatory bowel disease, and that is chosen specifically to be able to showcase all of these benefits that we're talking about, so we can kill two birds with one stone as it were, as we build the data pack.

Thank you very much, Alastair. So as we just mentioned, yes, oral delivery, very important. And what we have with N4 101 is a dual action RNA treatment for inflammatory bowel disease. And the idea is that with oral delivery, we're looking to replace the regular injections. So I'll go on with this slide a bit more about, but the market at the moment is dominated by systemic injectable products that do have side effect issues. And what a better way to deliver a product for this treatment area than having an oral capsule. And our oral capsule will have a dual loaded nucleic acid that's got two different RNAs. It has a messenger RNA and an siRNA, and I'll explain a little bit more about those in a second. And it's delivered directly to the GI tract. So it's working locally in the gut rather than being systemically delivered going around the rest of the body and ending up partially in the gut. And as we mentioned, it uses our proprietary non-lipid non-viral silico particle. And what we have been able to do is, as we mentioned, the targeting element, we're able to add a specific ligand. So in this case, we're adding a mannosylated ligand, because the macrophage cells are -- basically, they are the things that have gone wrong for patients that suffer from IBD. So if you've got IBD, what happens is your macrophage cells are producing way too much of this inflammatory cytokine, predominantly TNF-alpha, but there are lots of other cytokines associated with these macrophage cells that go wrong, and it produces this strong inflammation in the gut and that inflammation can lead to serious side effect issues and ultimately, even on to bowel cancer, because when you have such an inflamed gut, you have some real serious side effects. And it's important just to notice here that this is not IBS. So people often get IBD and IBS mixed up. So inflammatory bowel disease is predominantly ulcerative colitis and Crohn's disease. These are real serious diseases that patients have to treat. IBS, while still having serious consequences and side effects, is not a disease in terms of really associated with inflammation in the gut. So it doesn't have some of those serious side effect issues that you lead on to sort of real damage to the gut and ultimately, things like colon cancer. So IBS is still important, but IBD is the really big opportunity we're looking at addressing. And so what we're doing with this product. We are dual action simultaneously looking at two effects. So the first thing we're doing is, we're reducing the amount of TNF-alpha being produced, and we're doing that by adding an RNA called an siRNA that targets that TNF-alpha production. So as I mentioned, what happens is that the body is producing too much TNF-alpha. So with an siRNA, an siRNA is used to knock down -- used to reduce the amount of TNF-alpha that's being produced. But the other thing that happens with IBD patients is that, because there's so much TNF-alpha being produced, the body's own natural defense mechanisms, its own anti-inflammatory responses just get overwhelmed. So we're having a second part of our products. As well as having an siRNA delivered, we're also putting on a messenger RNA. And that messenger RNA is designed to promote something called IL-10, which is a particular anti-inflammatory response. So we've got two things. We're reducing the amount of TNF-alpha being produced, and we're increasing the body's ability to fight the inflammation that's already there. And this is really only possible, as Alastair was saying, because of the ease in which we can multi-load products onto our particle and deliver them both into the same cell. So we mentioned that, whilst this is a really strong product in its own right and it's something we want to take into the clinic in partnership, it also showcases all the key benefits that Alastair just went through talking about the Nuvec platform itself. And also why the IBD market? Because we see it as a big market, and there are problems with existing products. I'll just go through them a little bit more. So the current therapies, people started out really addressing IBD with things called immunosuppress. So they're basically looking at things that suppress that immune reaction that you have in the gut, things like corticosteroids, the Aminosalicylates. These are all drugs that are designed to reduce the immune system in the body. So unfortunately, what that has is, it reduces the whole thing and it causes some serious issues. So people have moved away from a general reduction in the immune system to something more targeted. So what people have been doing, they've been targeting TNF-alpha in particular, but they also target other cytokines, IL-26, IL-23, various things. But they're looking primarily at TNF-alpha. And these inhibitors are really -- they're about 78% of the market today, and they're the most common treatment. But although they're targeting TNF-alpha specifically, they still have side effect issues. So they are injected and that leads to problems. Lots of patients don't like having to go back in the hospital for regular, very inconvenient and sometimes painful injections. So you get really poor patient compliance. But because they're a systemic injection, they do tend to have off-target effects. They tend to have suppression issues around the rest of the body. Whereas, if an oral product is delivered locally to the gut, you're targeting your delivery into the area that's needed most. It's not a systemic issue. So what we have with Nuvec, because we're putting our RNA into a capsule, that capsule is then enterically coated. This is a standard procedure. This is nothing we're inventing here. That capsule is then delivered, passed through the stomach into the gut and there it's released. And that's one of the ways in which we really showcase how Nuvec is different with oral delivery. We've already mentioned, Alastair said, about the protective nature of it. But what you find with lipids and viral vectors. With lipids, if you put them in an oral capsule by the time they get to the gut, basically, the lipid nature of the product breaks down in the gut when it goes into the colon area, and it just won't work. It just doesn't deliver into the right cells. And with viral vectors, you can't really use them in the gut there, because if you're thinking about the toxicity that's coming from the viral vectors and you're trying to treat something that's already over inflamed, you're just going to make the matter worse. So we see Nuvec as a really strong point of difference by an oral delivery of these multiple different pathways into an IBD treatment plan. And it's a big market. There's over 5 million sufferers of those two types of IBD, Crohn's and ulcerative colitis. And because of that, the market was worth over $20 billion in 2023, and it's still growing at near 4% a year, and it will be over $27 billion by 2030. So it's a strong market with a recognized sort of leading treatment that has side effect issues that we're looking to overcome. So people have started to look at oral products. There are things called kinase inhibitors, they're JAKs, they call them, they call them JAK kinase inhibitors. And they are growing their share of the oral market. But they're a different pathway. They are -- without getting into science, their pathway that's above TNF-alpha. So they're actually looking to suppress things by going down an immune pathway, but they have real selectivity issues. They have -- they cause toxicity issues in other organs. So despite their main problems, they are growing. So we see there's a real trend towards oral, and there's a real need for a TNF-alpha inhibitor that's not an injectable, and that's fundamentally what we are developing. So a strong clinical benefit of the product, but also, as we said earlier, showcasing all the key elements of what Nuvec brings, the ability to target, in this case, we're targeting the macrophage cells, the ability to load multiple areas. We've got an mRNA and an RNA and the protection nature, which allows it to be delivered orally. And as Alastair mentioned, it's still a really simple manufacturing process, and we're using a standard enteric-coated capsule approach. So it will keep the cost of goods very low for this particular product. There are also some key players in this market that we can -- so it's being a big market, and there's some very big people operating in here, which really helps in my mind with the business development. So you've got a smallish pool of people that you can talk to and target for our particular product that we're looking to partner and license with and ultimately sell this to one of these companies. Just to give you some examples, they're all still very active. So AbbVie, they've got two approved products, and they're also developing one JAK oral product, which they've got in Phase III. So they're very active in both the existing market and also looking at developing new products that are coming through there. Amgen, they've got two approved TNF-alpha inhibitors, two injectable ones. And again, they're looking to develop further products. J&J are probably one of the biggest players in the market. They've got three inhibitors approved already, but they also have some products in Phase III trials. They're looking at something called IL-23 combined with another cytokine called SP19. So they're looking at different cytokines that are produced rather than just TNF-alpha. Pfizer are also big in this market. They've got one approved S1P1 inhibitor and are going through Phase III as well. And Takeda is another good example, they've got approved TNF-alpha inhibitors. So a lot of companies both active in the existing and also development. And overall, there's about 20 products going through late-phase clinical trials. So there's a lot of room for new products to look at the specific issues of reducing inflammation in this manner. I'll just hand over to Alastair now, just to give you a bit more of a flavor of what our programs are and what you can expect as investors in the company over the next year or 2 years.

Thanks, Nigel. Yes. So as I mentioned at the start, I think that N4 can deliver on some near-term value drivers as well as building that significant long-term value through its own drug pipeline. And the real value driver in the business is the Nuvec platform and the N4 101 program. And the partnership with SRI, which Nigel will expand on the next slide, that's also really interesting and a potential value add. So right now, given the resources available, the best way to add shareholder value is to build out a really robust data set that supports all of those key benefits that we've spoken about, the Nuvec platform. And that will allow us to secure platform licensing and partnering deals. Obviously, it's impossible to predict exactly when that will occur. But we need to build out that data set, because deals are driven by data, end of. The better the data, the more comprehensive and complete the data set. So you can answer all of the questions on those business development meetings, the sooner and better and more significant those commercial partnerships will be. So that's a key focus for us for the next 12 months. I think, focus is an important word, really focused on building out that data set so that we can support all of the statements. I mean, obviously, there already is a body of data. We have data to support the statements we've made, but we really need to build that out to be a more comprehensive data set. And that work is relatively cheap and straightforward. We're not talking the same sort of costs as late preclinical development costs. So relatively cheap, relatively straightforward, but the returns could be very significant. To maximize the opportunity for shareholders, it's absolutely critical that we progress our own assets or assets into the clinic as the resources allow. And as Nigel mentioned, a lot of the data that can -- that we want to develop for the Nuvec platform business development can be generated using N4 101. So we're killing two birds with one stone, very cost effectively, edging N4 101 towards the clinic as well as building out that data set. So there's lots of potential for good news flow. There's potential for news flow relating to N4 101. And the next key inflection point is around in-vivo proof-of-concept. So basically efficacy in-vivo proof-of-concept that's being carried out in Q2 by our partners, University of Queensland. And following that, we'll be engaging with the FDA to seek some pre-IND feedback on the oral IBD products, and that, obviously, we'll share with the market. In the meantime, as I said, a real focus of resources on building that data set, and we'll share all of that data. It's all the things we've spoken about, I've listed them there on the slide. And we will share all of that with the market as we progress through 2025. At the same time, of course, we will be out on the road speaking to people from a commercial perspective with the ultimate goal of delivering commercial partnerships for the Nuvec platform. And those will be with un-competing RNA therapeutic companies, as I said, impossible to say precisely when the first of those will drop, but absolutely data-driven. So you should be watching as we generate that data and share it with the market as we go through 2025. I'll hand back to Nigel now, talking about the SRI collaboration, I think. Nigel?

Thank you very much, Alastair. Yes. So SRI, they are -- basically stands for Stanford Research Institute. They're a very large research-driven company in the United States. And what they have is a system, which they call their Fox-3 MGS targeting system. And what it is, there's a bank of -- they've got around 30-plus peptides. And these peptides are used to target specific cells. So that, if you add the peptide to a payload, it will only get taken up by the selling question is, the element, the key point of difference of what they're trying to do. And what we've managed to do with them is we've successfully shown that we can combine their peptides to the Nuvec nanoparticle. And through experiments, we've shown that we can show that, that combined Nuvec Fox-3 particle is only taken up into certain target cells. But not only is it still taken up, by having the peptide on there, it doesn't interfere anyway with the knockdown of the particular target gene. So in these experiments, we've taken, an siRNA, we've put it on to a particle that's the standard Nuvec particle, that has also got a Fox-3 peptide on there and then shown that it's taken up into the specific cell for that peptide where that peptide receptor is only working and still knocks down the target gene in effect. And what we are looking to do is, we're presenting that data to major pharma players, both ourselves and SRI are doing it as well. And occasionally, we do it together. We're looking to actually get them to work with that combined SRI N4 Nuvec system. And the model that we're operating is based around the fact that we've both got these different background IPs. So SRI have a strong background IP in a range of these different peptides. And Alastair already mentioned earlier, I was going to talk a bit about our background IP. We've got a matter of composition patent for our Nuvec system that is granted in all the major territories: U.S., Europe, India, China, Japan, et cetera. And it's a matter of composition. I mean, the patent is around the structure and shape of that silica mesoporous particle. So no one else can develop a spiky structure like this, where you've got this mesoporous particle. Mesoporous particle, imagine something like a practice golf ball. So it's a hollow sphere with tiny little holes that giving that sort of hollow look. But then you have this spiky structure that's grown around the edge. So no one else can do that with silica, that can grow this spiky structure. So it's a very strong piece of IP, as I say, that's granted. And we're looking to combine our technology with the SRI technology, combine that with a major pharma partner's cargo. And together, that will allow new IP to produce. So there will be a 3-way relationship between the IP. So we're looking to do the work, the research work with SRI, the background IP, the licensing will come from the Nuvec and the partner will take that, hopefully, that product into clinic themselves. So it's a very strong and proven business model. And SRI have already worked with a number of players, and they've worked with virtually everybody in this space. So we're really excited by this collaboration. And we're really hopeful that it will lead to some more -- some earlier licensing deals as we develop our own data package ourselves we'll be developing extra data with SRI as well as we go forward. So just a little bit of an overview of the commercial strategy. We have a proof-of-concept platform with N4 101 that we're looking to take into the clinic ourselves. Alongside that, we're looking to license our Nuvec platform to partners who are looking for new delivery systems in this space. We've talked about the benefits that Nuvec has, the issues that you have with viral vectors and lipid systems. And we do know that people are looking for non-lipid non-viral systems that help get their RNA treatments and therapeutics that they're developing into cells and into specific targeted cells. So we have this two-pronged approach of developing our own assets. And ultimately, there will be more assets that we'll be able to bring. The Nuvec system can be used in a number of different areas. So there's a lot of potential both for licensing deals with the platform and also bringing new assets through as we build and continue to grow the business. So we'll only do that when resources permit, but the upside potential, we believe, is absolutely huge. And we're looking to say, initially take at least one product in the clinic ourselves. So we're looking -- we'll have to partner the first ones, because we won't have the funds to do those all into Phase I clinic ourselves. But as we get those funds and begin to develop, we can take our own products into Phase I clinical trials, maybe Phase II trials. So the values then start to grow exponentially. And you see the sort of numbers that I've mentioned earlier from some of the companies that have already done this with their own platforms. So in summary, we are rapidly growing our RNA therapeutic market, $18 billion by '28, but that market faces significant issues in delivering drugs to the right place, and they're looking for systems like Nuvec, which we have shown has the potential to really revolutionize this space, because we're solving the challenges that these manufacturers are looking at for their own RNA therapeutics, namely getting that targeted delivery into specific cells so they can have the desired clinical effect. We're focusing our own lead asset on the N4 101 program, which is the product for inflammatory bowel disease. And that showcases all the key benefits of the platform. So as well as doing that work, we're continuing to build the platform. So as Alastair said, we're killing two birds with one stone. So the two elements of the program are complementary to one another. So we feel that we're very well positioned to deliver some long-term shareholder value. We've got some significant opportunities both in the near term and ultimately with new opportunities that will come further down the line. And just to say a brief reminder, the next big piece of data that we'll be having is the results of our in vivo work on the anti-inflammatory action, which was somewhere around about April, early Q2 in 2025. So that's a summary of N4 Pharma. I'm taking you through our technology, our platform, I'll just leave you with this slide. We have an investor hub. If you want to find out a little bit more, sign up to that, please do sign up. We regularly update the market on what we're doing. And we're also going to be doing a series of videos talking a little bit more in detail on each of these aspects about the nature of the market we're in, the N4 101 program, a bit more about RNA therapeutics. So more educational pieces around the company and the strategy of how we're developing our platform. So I'll hand you back now to Jake. So thank you very much, everybody, for listening to myself and Alastair, and we'll have some question and answers now, I think.

Perfect, Nigel, Alastair. If I may just jump back in there. Thank you very much indeed for your presentation this morning. [Operator Instructions] I'd just like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A can all be accessed via your Investor dashboard. Guys, as you can see there, we have received a number of questions, and thank you to all of those on the call for taking the time to submit their questions. But Nigel, Alastair, at this point, if I may just hand back to you just to read out those questions and give your responses where it's appropriate to do so. And if I pick up from you at the end, that would be great. Thank you.

Yes. So why don't I read them out, Nigel. So the first one is, will you need to raise capital in the next 12 months?

Good. Well, we're not able to comment on the timing of any particular fundraising or indeed any other price-sensitive data. But what's clear is, we're a pre-revenue biotech. And pre-revenue biotechs need to raise funds to develop our assets and also to grow the shareholder value. We've talked about what we're looking to do with our platform data. So we're always looking to grow our share price, to allow funds to be raised as efficiently as possible, but we're also continuously exploring non-dilutive options such as grant funding. And ideally, when we get our first commercial deal, that will give us a significant source of funding as well to carry on developing our program.

How close are you to collaborations for Nuvec?

Right. Well, our ability to actually do collaborations and the value of those, as Alastair mentioned earlier, is entirely dependent on the data set that we build up and the quality of the data in this sector. So we're looking and working hard to develop our platform data as well as progressing the work on N4 101 in the IBD space. And we obviously can't comment on any specific commercial discussions, but we're really hopeful, and we've made it clear, I think, in the presentation that we believe deals will come from the data. We're spending the time and effort developing the data. So we're in a strong position to secure licensing deals for the platform. And then, we're building on that, the N4 101 program. So there's always a risk that the company is not going to be able to secure the licensing deals and the platform in the right time in the coming months. But this is entirely dependent on the quality of the data that we're building. And we believe we do have some very strong data already, and we're going to be adding to that significantly in the next few months.

Okay. There's a question about, a retweet actually, it was an article on bowel cancer, Nigel, and says, as 3 out of 10 cases of bowel cancer derived from IBD, okay, so inflammatory bowel disease, I think you mentioned that Nigel's not the same thing as IBS but IBD. Is it not the case that by controlling IBD, you can reduce the number of bowel cancer cases? And is it also not the case that with -- if N4 101 can turn off the gene causing IBD, then it can also be adapted to turn off the gene causing bowel cancer? Was that a little bit more? Sorry.

Long question. That's fine.

It keeps on giving. As Nuvec can be multi-loaded, it could also be possible to treat IBD and prevent bowel cancer at the same time from a single treatment using Nuvec. So I think the question is about our ability to address IBD and how does that impact on bowel cancer.

Absolutely. Yes. So we retreat this, and we retreat a lot of exciting work that's going on in the industry, because it's really good to see IBD in the front of the news for us and things that have been developed. And yes, this work shows that there is a strong link between patients who have IBD who then go on to develop bowel cancer. It's not everybody. So we're not implying that everyone is going to get bowel cancer at all. But I think, they're saying the 3 in 10 people are going to go and get bowel cancer. So if you can control the amount of inflammation from that, you can help with the treatment of bowel cancer as well. And it was also -- yes, the other part of the question that was mentioned that you can do multiple things. So yes, we are capable of loading multiple siRNA onto the same particle. So there should be -- and there could be really an opportunity in future development programs that we could load both an anti-inflammatory to treat IBD and also an siRNA to combat bowel cancer on the same particle. And this is one of the examples of how Nuvec can be formulated to give specific pathway benefits for two different diseases in the same treatment. So that's very much in the future. But yes, there are many different applications for our delivery system even in this one particular space, which will be an oral delivery area, but there's also lots more out there as well.

Is there a near-term update due on ECP 105 and its orphan drug status?

Yes. So just for those people that may not know, we recently took a 75% stake in a small biotech called Nanogenics. And what they have is a product called ECP 105, and it's a product which is delivering an siRNA gene to help treat from scarring fibrosis caused by glaucoma surgery. And what's really important for that particular product is orphan drug status. So we've submitted an application to the FDA before, and we've had some feedback, and we've gone back to them just before Christmas with the response to their initial feedback, primarily around defining the precise market. So whilst we're looking at a specific part of glaucoma with Nanogenics, they were wanting to ask, could it be used for other areas as well. And we've gone back to them, and we should get a response from that very soon, hopefully, end of February, March when they typically take the 60 days. But with Christmas being in the middle, we're not sure exactly when we'll get our response. But as an orphan drug status is quite important or very important for that particular program.

If orphan drug status is granted, is it N4's intention to apply for grant funding to take ECP 105 to clinical trials yourself? Or do you intend to partner?

Right. Well, as I mentioned, orphan drug status is pretty very important for this particular product. And if we get orphan drug status, that's going to put that program in a really much stronger position, because it's highly attractive status to have for orphan drug for this program. So it's really going to help in securing either a commercial partner to take that product through into Phase I clinical trials or an investor to come in to the Nanogenics company and provide the funds for Nanogenics themselves to take that into Phase I clinical trials. And also, the company is looking at non-dilutive grant funding. There are always grants coming around and up, but it's a highly competitive process. So they will be taking part in that bidding for trials and having orphan drug status will make all three of those elements much, much easier to achieve.

To avoid further dilution, partnering is obviously preferable to a fundraise. In which of the two products do you see the greatest opportunity for partnering in the near term? I think, we've probably answered that during the presentation, but you can cover that again, Nigel.

Yes. So the greatest value that we're going to deliver to shareholders is really ultimately by advancing N4 101 into clinic and by establishing our platform as the go-to choice for people developing RNA therapeutics. And that's where our focus has got to be for the foreseeable future. And partnering either asset of those will be entirely dependent on the quality of the data and the depth of the data that we're going to be generating. And we really do believe that the Nuvec platform can generate both near-term and commercial licensing deals as the data set on that platform grows. And that's where the bulk of our resource is going to be spent into 2025, showcasing the platform, but also doing that, as we mentioned, in a way that also working on N4 101, so it leads that across to the platform as well and the platform helping to understand what we can do with N4 101. But in the long term, we're going to create ultimate value from our own pipeline that we'll have in this space, just like those other companies have done in this space by making that platform available for both other companies and also for ourselves to develop a whole range of different assets into different clinical trials and treatments.

When do you expect ethics committee approval for the Nuvec in vivo study? And how long should it then take to complete the work and publish the results?

Well, we've already submitted the application for ethics approval, and they're going to be meeting, I believe, in the next couple of weeks. And assuming that gets approved, then we will be able to start the in vivo study itself in March this quarter. It's quite a short actual study itself. So the actual study doesn't take that long, but then we'll need a few weeks to get the results, analyze them and get them back to the market. So hopefully, sometime in the sort of maybe the middle end of Q2 to back end, we will have the results of the in vivo testing. So this is looking at an animal model to see if we can reduce the amount of inflammation caused by delivering our oral product into the localized gut and so basically reducing the inflammation directly. So really exciting data that we're hoping to generate and release in Q2.

Final question, I think, Nigel. Although I guess, we're very happy to address any other questions that come in perhaps with a written response, Nigel, is that?

Absolutely, yes. We have some questions we can, we'll get access and get response to all the different questions as we can.

Yes. So final one. Subsequent to the 2024 SRI development work, has there been any further interest from potential commercial partners to license and develop Nuvec?

We, as I said, we can't talk about any particular discussion. But the SRI work has already shown that we can now easily add peptides and other targeting ligands to the Nuvec system. Silica is a very good system for chemically adding these peptides and targeting. So it's, that itself is adding significantly to the data pack we're developing. So taking that work and putting it in front of partners obviously makes our system more attractive and therefore, those licensing deals are more likely. And as we said earlier, the number of partnerships and the quality of the partnerships we can make will really depend on the data that we're able to deliver. And SRI work is just one aspect of the platform that we're developing, and we will be looking to present that data alongside all the rest of the data that we have with our platform and other ligand. So we're not using SRI with our oral IBD product. We're using a different targeting element there, as I mentioned earlier called manolist to target the macrophages. So yes, the SRI work really does bring to forward the targeting nature and how easy it is to do that with Nuvec. So I think, that's the end of the questions for now. We're running out of time. As I say, we'll look to respond to the others. And I'll just hand back now over to Jake.

Perfect. Nigel, Alastair, that's great. And thank you very much indeed for being so generous of your time then addressing all of those questions that came in from investors. But Nigel, perhaps before really just looking to redirect those on the call to provide you with their feedback, which I know is particularly important to yourself and the company. If I could please just ask you for a few closing comments to wrap up with, that would be great.

Yes, sure. So as I say, we've got a really strong position in the -- with the technology that we're developing. We think, it can add significant value. And I would just advise everybody, if they're interested in following us closely, go on to our investor hub. You'll see the QR code at the end of our presentation. Sign up there. We'll be doing lots more communication about the program itself, the areas that we're working in. So you people can understand the company and what it's trying to achieve and literally the business model and why we think there's such an important opportunity to really add value here with the platform that we're developing. So again, please come along to our hub, keep interacting with us. We're really keen to work with and interact with investors and keep you abreast of what we're doing.

Perfect. Nigel, Alastair, that's great. Thank you once again for updating investors this morning. Could I please ask investors not to close this session. You'll now be automatically redirected for the opportunity to provide your feedback in order that the management team can really better understand your views and expectations. This will only take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of N4 Pharma plc, we would like to thank you for attending today's presentation. That now concludes today's session. So good morning to you all.

Thank you, everybody.