Thalia Therapeutics Plc (THAT) Earnings Call Transcript & Summary

Thank you, and welcome to today's run-through of the new corporate strategy presentation for N4 Pharma. I'm just going to take you through some of the key highlights in the presentation that will be available on our website. So let me start further without further ado. So just to give you a bit of an overview. We see this as a really exciting time for us at N4. So for new shareholders coming into N4 and existing shareholders as well, we see ourselves as a highly undervalued biotech. There are significant opportunities to get multiple increase in valuation from where we are today with the research that we've done on our delivery systems and the strategy that we're about to embark on. So we've established a while back. We are focusing on the nucleic acid delivery space. This is the next big development we see in the pharma biotech world, and this has been borne out recently by the COVID-19 vaccines, that were very much the Moderna and biotech vaccines were based on messenger RNA. The nucleic acid market itself is a very large state, but it's going to be growing even larger that we have $15 billion by 2033. And we've got 2 different delivery systems with strong preclinical data that we're working out in this space, and we feel that we can create some really interesting differentiated nucleic acid therapies. So as I say, we're a preclinical stage at the moment, and we are evolving away from just being a platform company to being a platform company with their own products that they're looking to take into Phase I clinical trials. The first is called N4 101, which is an oral formulation of a TNF-alpha inhibitor, looking at treating irritable bowel disease. And the second is we call ECP105. This is the prevention of scarring with an siRNA compound for a gene after glaucoma surgery. Both of these use different proprietary delivery systems, which I'll go on and describe a bit more. And both of these programs say we're in preclinical development, and we're looking to get anticipated IND filings in 2025, by 2026, at the latest. And we're looking to partner with people to take these into Phase I clinical trials. And the funds from the first one, we'll be looking to take the second one into Phase I trials ourselves where if indeed, we license both, we'll be taking the funds from those to look at new opportunities that we can actually bring to market. So a little overview about the platforms. Again, this data is on the website. The key things are that we have the ability to target our systems to specific cells. And this is something that we've added recently to our portfolio of R&D program that we've been looking at. They're not toxic. They're very inert. So unlike viral vectors and lipids, which will have cytotoxic impacts, we don't have that with our systems. And very importantly, with Nuvec, we've shown we can get multiple payloads onto the same particle and deliver them into the same cell. And also, we can get oral delivery with a Nuvec system. They're patent protected. We have a very strong suite of patents for the Nuvec system, and the LipTide system is backed up from its original patent, which runs out shortly with specific lipids in peptides that you can add on to that. And that's really important because although the lipid space, there's lots of patents in there, is fraught with litigation. So people are having legal fights all over the place about who owns individual lipids. So ours is a very clean patent protection around our silica system. The oral IBD treatment is -- what we're looking at is looking to replace regular injections. So the need for injections is sort of seen as a bit time consuming, can sometimes be painful for people. Having an oral capsule with a dual-loaded nucleic acid that's delivered straight to the gut with a dual action response that's basically looking at reducing TNF-alpha production and promoting the body's own inflammatory response, we think, is a real strong point of difference in this market. The reason it's important is because in patients who have IBD, people don't know what the cause is for IBD, but the impact of that is you get an increased inflammation in the stomach, the gut. It could be anywhere in the system. But it's fundamentally because what happens in IBD patients that are affected, they have altered macrophage cells. And these altered macrophage cells produce excessive amounts of the inflammatory responses, particularly like TNF-alpha, but there are others as well. And knocking down that TNF-alpha is seen as a real cause to try and help with those symptoms. You're not curing IBD, but you're treating the symptoms of IBD. And as I mentioned earlier, the market at the moment is dominated by TNF-alpha inhibitors, antibodies that are injected. Some 78% of the market is through this, right? But these are often come with sort of tolerance issues, some people are nonresponders to this. And there is sensitivity to the immune response that comes out from that. And the side effects in these regular injections just make it a not very attractive product for the patient. But -- and we -- it's still a huge market, though. There are over 5 million sufferers worldwide, and the market was already $20 billion, and is still growing, and we expect to be around about $27 billion by the end of 2023. And the trend already though is towards oral treatments. As I mentioned, it's a logical thing to do. If you've got an IBD problem, you want to take an oral product ideally, rather than have an injectable solution. And people are developing things called JAK inhibits -- these are JAKs, Janus kinase inhibitors. But they suffer from having a lack of tissue selectivity, so they end up causing problems in other organs. But even so, the oral side of the market is expected to be worth around $7 billion by 2030. But what we see is the N4 101, our product, will be an overall version of TNF-alpha inhibitor will replace all those painful inconvenient injections that have systemic side effects, and also replace the need for the complicated JAKs inhibitors with our oral version. So we see the trend to oral and the trend away from injectables is something that's key for this particular market and the one thing that we tend to exploit. I won't go through the mechanism of action. This is available on our website. Just to sort of -- you can find out and see how it works in terms of how we get siRNA into the cells and how it knocks down. But again, if people have questions, please ask about that. Also a little bit of an example to show that we've done a lot of work already in this space. Showing on the left, you can see that this is just some data where we've shown that we can deliver Nuvec orderly, and it is effective in the gut. And also how we can double load on the right different siRNA so that they produce a synergistic effect to have a better response. So this double loading and the oral delivery that we're bringing together to work in our IBD product. What we will be doing over the next 6 months or so, we'll be doing all the in vitro testing, looking at that TNF-alpha activity, looking at the inflammatory actions to see how we can improve that, the anti-inflammatory actions. We've also been taking in vivo. So we'll be doing an oral capsule to demonstrate in mouse models the reduction of inflammation. And that work will be starting, hopefully, at the end of this year and will carry on through to mid-2025. That work will be done with the University of Queensland partnership that we have. It's a lot of exciting work on our IBD product. I also mentioned the glaucoma product, which we acquired through the acquisition of Nanogenics. So trabeculectomy or what's called glaucoma filtration surgery is the gold standard treatment for patients who are going though -- who have interocular pressure as a result of glaucoma. However, what happens is these patients get scarring caused up by the fibrosis of the surgical procedure trying to repair itself. Well that causes the surgery to fail. What happens at the moment is that people use an off-label product. They shouldn't really use it, but they do because it seem to somehow work. And that's called mitomycin C, but it's highly toxic and only really be used once. So what 105 looks to do is to basically address that unmet need by matching the performance of mitomycin C to reduce that scarring and help with the postsurgical repair, but without exposing the patients to all those high toxic side effects from using mitomycin C. And the reason why we think this is a really good opportunity for this LipTide technology is there's a huge amount of glaucoma. So there's 70 million to 80 million people worldwide. And there's around 300,000 specific glaucoma filtration surgeries each year and they're growing. And there are other procedures as well that also lead to scarring. And the cost of the surgery is pretty high. And even if we position 105 between $600 and $1,000. That still gives a really big market opportunity for that particular brand. That's just estimates at this stage. There could be a lot more surgical procedures that we can use it in and we can actually achieve different pricing. But it gives you an example of the sort of size of the market opportunity for a glaucoma trabeculectomy product. And as I say, we're looking to replace the use of mitomycin C, which is currently an off-label use, but with the same efficacy. It works using the LipTide that we acquired with Nanogenics. And this system will put the siRNA inside, and it has peptides to help get to take up into the cell. And what happens here is that the MRTFP gene, which this siRNA is encoded for will be introduced to the cell, and it will stop the formation of those fibroblast that caused the scarring. And work that's been done so far in the preclinical setting is very good. So this is -- the green line shows you the standard procedures, sort of how long this light, they call it, which is the area that will end up reducing the pressure in the eye but then scarring and then causing the surgery to fail. So if I can keeping the way surviving, which is what mitomycin C does. We've seen here that we can already match that. So the red and blue is the same basic performance. But without those cytotoxic side effects that you see from mitomycin C. So a very good set of preclinical data, which we're looking to now take forward and get into Phase I trials with partner. And the reason we look at these 2 areas because there's lots of people operating in this space. So it gives us very specific targets for the type of companies that we can look to work with a partner alongside us to get these products into Phase I clinical trials and then ultimately beyond into Phase II and Phase III trials. Some of these are very big, some of these are very specialist partners, but there's a lot of people who we can actually work within this space, and we'll be targeting all of these people with the data as we get it. But although that we're doing these 2 products ourselves, we're doing as well as actually being product opportunities and exciting value-creating opportunities in their own right. It also showcases the platform. And we've also been doing this work with SRI recently. And the SRI work has shown how we can add these targeting peptides to Nuvec, so that they only get taken up by specific cells and still get strong knockdown in that specific target gene. And we're presenting that data at the moment to major partner players. And all our research and conversations that they're targeting is the #1 thing that people are looking to achieve with any delivery system for RNA, siRNA and even mRNA. So we're really excited by this data that we're developing with SRI. And the SRI model is very flexible. Our business model is looking at working with partners who have research programs to then define the scope of that work in conjunction with SRI. We will take that into an early stage with a preclinical study, and then ultimately into licensing and option agreements to use the technology to further that program into clinical trials and ultimately, hopefully on to final product. The IP strategy is fairly straightforward. We have our own background IP in N4. SRI have their own background IP with those FOX Three systems, and the part that will have their own algo that we're looking to bring on. So there'll be a combination of the 3 different things to create new IP that will be jointly owned as we walk through this program together. So very exciting times with both our own products and also with the SRI collaboration. And this will lead to some big value inflection points. I mentioned right at the start, I see this N4 a hugely undervalued company based on the technology we have, the opportunities we can work in the markets that we can actually develop. So as we move through these phases, hitting some of these milestones, we'll see big uplifts in our valuation. These key value inflection points that will allow us to bring in new products, bring in new investment as we get a much, much higher valuation of the business. So things like when we get the final completion of the in vivo work on our 105 and our 101 products, we'll be getting collaborations hopefully, with SRI sometime in 2025. And then we'll be getting IND filings in '26 and '27 for different products. So big key strategic milestones that we'll see our valuation will grow significantly. And commercial strategy around this, as I mentioned, is that we look into license at least 1 of these lead programs with a partner to take it into Phase I clinical trial. We might do both. But if we use the product -- the proceeds from the first one, we can then take the second one into clinic ourselves. Or we can use those funds to take the product 3, product 4 that we're still looking at developing. We're looking at other areas, particularly with our multi-loading approach for oncology and gene therapy. And that will allow us to broaden the portfolio beyond just our first 2 lead programs. And we're also offering this proven concept work that we're doing with these 2 programs will then lead people to be, I think, really interested in developing their own platforms, their own products using our platform technologies. And this has been a proven business model for many different platform companies. This is something that we see as a natural evolution for us. All these companies have moved from being platform companies to the companies with their own lead products in various stages of clinic, some preclinical, some early stage, some in Phase I, some Phase II, some of them on the market. And the valuation is raised from the hundreds of millions through to the billions. And these are all companies that use their unique proprietary platform to develop their own products and then license those on to major pharma companies. And we see this is the way that we're going. We just got to go through this process very slowly to get to some of these valuations that we feel our company is more than capable of delivering. So just in a bit of a summary, N4 Pharma, we're really focusing on the fact that we're a targeting system. We're a targeted delivery system now. So we're targeting nucleic acid medicine company. We have 2 lead products that we're looking to take into Phase I clinical trials, looking at unmet clinical needs based on our own proprietary delivery platforms, Nuvec and LipTide that provides us with the competitive biology. So as well as just telling people about our competitive advantage, we're using it to show that advantage in products that we're developing ourselves. And this will lead to some pre-IND filings in, say, 2025 and '26, all of which will give us big increases in valuation as we find partners to help take us through this. And ultimately, if we get in our own Phase I clinical trials, we can license them for much, much higher valuations, and all of those using our proprietary cell targeting delivery platforms. So there's lots of other data in the appendix which we'll leave on the website. So thank you very much for coming along to find out more and go through this first run-through of our new corporate strategy presentation. If you'd like to leave any questions on our investor hub, please do. And we'll be collecting those together and doing a follow-up video sometime next week where we'll try and answer as many of those questions as we can. As I say, thank you very much for coming along and listening to the run-through of the presentation today.