Thalia Therapeutics (LSE:THAT) — Investor Webinar

0:01 Good morning, ladies and gentlemen, and welcome to the Enfull Pharma PLC Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged. They can be submitted at any time via the Q and A tab that's situated on the right hand corner of your screen. Please just simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and we'll publish those responses where it's appropriate to do so on the Investor Meet company platform. Before we begin, we would just like to

0:32 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 Enfor Pharma PLC. Nigel, good morning, sir. Good morning, Jake, and thank you very much for the introduction. And and thank you everybody for joining us today. My name is Nigel Thierbold. I'm the chief executive of n four Pharma. And we're also joined today by Alastair Smith, who is a recently appointed non e exec director. And Alastair will give you a bit more of a background on himself as we go through. So without further ado, I'll I'll just walk through our investor presentation. I just wanna give you, first off, a little bit of an overview of n four. So, yeah, we see ourselves as a really exciting investment opportunity in what is a very differentiated and hugely successful and growing biotech market. And And we see, you know, significant upside potential for us as a business based on where we are today with our current share price.

1:31 And what we're doing is we are developing 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 called n four one zero one. And what that is is a dual targeted, orally delivered RNA therapeutic. And it's designed to for improving the lives of patients with a disease called inflammatory bowel disease, which is a very life changing disease condition and causes lots of side effects.

2:16 So the reason we're developing this product is that it also showcases the best pal parts of our Nuvec platform. So as we take that fall into clinic, we're also doing the work on our basic platform to show how case how good it is. 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 listing back in 2017. So that's a bit of an overview of the business, and I'll just give you a brief rundown of Boise. I'm the founder. I've got over twenty five 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.

3:04 Luke Kents is a corporate affairs director. He's got a lot of background working as a nominated adviser in Northern Capital Partners, stock breaking firms. So he brings a strong corporate element to the board. Chris Britton is our nonexecutive chair. Chris has got significant business development experience working across a large number of different players. He's been global head of m and a at Sandoz, a business development head at Sanofi PLC. He he he he just brings a a really strong corporate and commercial overview to the business. We've also recently employed to doctor Mike Palfreman.

3:50 He is US based, and he's got a lot of experience working in The US 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 of yourself. Alastair just recently joined us as a nonexecutive director. Alastair. Oh, thanks, Nigel. Well, I guess many people will know me from AVACTER Group, which is a company I founded and and ran a step step back last year. I'm a I'm a scientist by by training, but we're obviously with a very strong commercial bent. And since I stepped out of the VACTER, I mean, just just to give people a, you know, a feeling for, you know, why why I think n four pharma is an exciting opportunity. And I don't wanna preempt the entire presentation, but just to give you, you just to give you some brief thoughts.

4:47 I've been looking for companies with strong technology, open, honest management teams that that are undervalued. And as we're gonna talk through in the presentation, now N4 Pharma's addressing a a very rapidly growing market, the markets 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.

5:15 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, you know, I I really don't believe that the potential of the Nuvec platform is anywhere near reflected in n four'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 I'm very pleased to be involved.

6:03 Excellent. Thank you, Alison. Thank you for that. And we're really glad to have you on board as well. So Thank you. Yep. So as Alison said, you know, 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'll be over $18,000,000,000, by 2028. But as Alastair says, 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 those sorts of targets.

6:50 And we do have the potential to revolutionize gene therapy. We we have solved significant challenges of how to manufacture simply and easily our system, how we can target it to to specific cells, and, you know, it's very, good at delivering RNA therapeutics. Messenger RNA, siRNA are the main two that we are looking on.

7:13 And as we said earlier, what we've what we've 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'll demonstrate that, but it showcases the the key benefits of the platform. We talk about the the use 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 to build the dataset 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.

8:07 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 new platform, but also developing ultimately our own pipeline of RNA therapeutics. And as as I as I said, this is a proven model for platform companies. So just wanted to give you a bit of an example here. There there are five companies here. Now I won't go through them all in each detail, but what 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, government AeroViroteic BioTherapeutics.

8:52 They have a platform based on proteins to deliver compounds. And they recently raised for over 41,000,000 at a 400,000,000 valuation. And they only have three products in early stage development. So no products on the market, but they're going through the clinical phases. Arrowhead's another very good example. They have an siRNA platform that is able to target specific tissues. And what you'll see from our our our discussion later is that's exactly what we have. We have a platform that can target specific tissues, do other things as well, but it delivers siRNA effectively. And they now have a market cap of over 3,000,000,000. And, you know, look at Dicerna, they've got a platform based on a GalNAc technology. DTX have got a platform based on fatty acids. So each of these companies have taken a platform, showcased their platform, but then ultimately developed their own therapeutic products, which have given some really large valuations.

9:49 And that's where we wanna get to, but we wanna get there within the means that we have. So, you know, it's a big ask going from 2,000,000 to 2,000,000,000, but it this is this technology has the potential to do that. So we're just gonna give you a bit more of an overview about how we're going to actually do that now. So I'm just gonna hand over to Alastair for a couple of slides just to talk you through a little bit more about the NuVEX system and its benefits. Over to you, Alastair. Alright. Thanks, Nigel. Yeah. So just just to reiterate the points made earlier. RNA therapeutics, as Nigel said, is a is a very large market, growing very rapidly. Lot of commercial I mean, a huge amount of commercial interest. But 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.

10:43 Now Nuvec doesn't rely on the same viral or or lipid technology. It's a silica based nanoparticle. As you can see from the, you know, the image there, it has a a rough surface, a spiky surface, if you like. And it is 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 and deliver it. And that's really the basis of why I think n four pharma has a, you know, very bright future. So, I mean, just to talk through the the main key benefits, there's there's other things we can talk about, but the main key benefits 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 of the two different RNAs that you put onto the particle. And that that is

11:50 extremely difficult to do with other platforms. So 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 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 in pH.

12:37 Now that's extremely important because RNA, as I said, relatively fragile, very easily broken down in the bloodstream, for example. And the the ability to protect the RNA in the way that we can with Nuvec facilitates oral delivery. Now that that is, I'll 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

13:09 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's mentioned a couple of times the need, the desire to target treatments to specific tissue rather than relying on a nonselective 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.

14:05 In terms of well, 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 the 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 in the solution of the RNA of interest. The particles are stable at room temperature, which means you can transport them and and store them, you know, very straightforwardly. So from a from a practical perspective, not only does this this platform have some real key biological benefits in targeting multiple payloads, payload protection or delivery, but it's straightforward to manufacture as well.

14:55 Next slide, please, Nigel. So, you know, these types of comparison tables, you know, are very binary, aren't they? A tick in one box and a no tick in another box. That doesn't really deal with the nuance, of course. But let let's let's use this to at least look at what you know, how how Nuvex sits in comparison with the, you know, the standard methods of of delivery that are available today. And as Nigel mentioned, you know, that 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 but taking this table, you know, for for face value, first of all, interchangeable payload. Can we deliver RNA, mRNA, siRNA, DNA?

15:45 Yes. All those can be delivered. And indeed, they can with the viral and the lipid platform. So that that's 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, haven't mentioned that yet. Clearly, again, like manufacturing, if if these particles were significantly toxic in any way, then then that would be a a major issue. And and we're we're not gonna show data today, but there is data showing that the sort of concentrations that we want to use these particles are, you they they have no significant cytotoxicity.

16:31 So that that's obviously a major tick in the box. And, you know, certainly, viral systems do have issues with with toxicity, significant issues with toxicity. Multiple payloads we talked about. Can you controllably, with a with a known ratio, load more than one RNA into the delivery platform. Very straightforward with Nuveq. Very difficult to do with the other platforms. You end up with empty particles. You end up particles with one in, particles with two in. It's it's not a controllable process. Not straightforwardly, anyway. Nonviral really speaks to the the cytotoxicity point that we made earlier. And, clearly, our platform and lipid platforms don't have that potential toxicity risk.

17:18 IP. Nigel will mention IP. I'm sure the the Nuvec platform is well protected by granted granted patents in all the major territories. So there is a and, of course, it's proprietary to n four. So it's a very simple, clean

17:36 IP landscape with no no stacked royalties. It it belongs to n four. So that's a very straightforward IP position. I I guess, just just to, you know, being completely open and frank, you know, it it's a new platform, which is why we have to build out the the dataset to really demonstrate with robust data these key benefits that we've we've talked about. There 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, you know, around for many years, and there are approved therapies using those platforms. So Nuvec is earlier in its development.

18:21 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 n four one zero one, we'll mention 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. Thanks, Nigel. Thank you very much, Alastair. So as we just mentioned, yeah, oral delivery, very important. And what we have with n four one zero one is a dual action RNA treatment for inflammatory bowel disease.

19:13 And the idea is that with oral delivery, it we're looking to replace the regular injections. So I'll I'll go and explain a bit more about but the market at the moment is dominated by systemic injectable products that do have side effect issues. And it it what a better way to deliver a product for this treatment area than having an oral capsule. An oral capsule will have a dual loaded nucleic acid that has got two different RNAs. It has a a messenger RNA and an siRNA, and I'll explain a little bit more about those in in a second. And it's delivered directly to the GI tract. So it it 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.

20:02 And as it we mentioned, it uses our proprietary non lipid, non viral silica particle. And what we've 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 mannose ligand because the the macrophage cells are basically they're they're 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 onto bowel cancer because when you have such an inflamed gut, you you have some real serious side effects.

20:57 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 real damage to the gut and ultimately things like colon cancer. So IBS is still important, IBD is the is the really big opportunity we're looking at addressing. So what we're doing with this product, we are dual actions 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.

21:55 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 used to reduce the amount of TNF alpha that's being produced. But the other thing that happens with IBD patients is 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 half part of our product. So 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 I l 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.

22:52 So we mentioned that whilst this is a really strong product in its own right and it's something we wanna take into clinic in partnership, it also showcases all the key benefits that Alice had just went through talking about the NuVet platform itself. And also, why the IBD market? Because we see it's a big market and there are problems with the existing products. So I'll just go through them a little bit more. So the the current therapies, people started out really addressing IBD with things called immunosuppressant. So you're basically looking at things that suppress that immune reaction that you have in the in the gut. Things like corticosteroids, amino salicylates. These are all drugs that are designed to reduce the the immune 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 immune in the immune system to something more targeted. So what people have been doing, they've been targeting TNF alpha in particular, and they also target other cytokines, I l 26, I l 23, various things.

24:04 But they're looking primarily at TNF alpha. And these inhibit inhibitors are really they're 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. We have 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. So it's not a systemic issue. So what we have with Nuvec, because we're putting out RNA into a capsule, that capsule is then enterically coated. This is a standard procedure. There's nothing we're inventing here.

25:03 That capsule is then delivered, passed through the stomach into the gut, and there it's released. And that's one of the the ways in which we we really showcase how Nuvec is different with oral delivery. We've already mentioned, as I said, about the the protective nature of it. But what you find with lipids and viral vectors with 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 in the in the gut when it goes through into the colon area, and it just won't work. It just doesn't deliver it 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 gonna make the matter worse. So we see NuVac as a really strong point of difference by an oral delivery of these multiple different pathways into an IBD treatment plan.

25:56 And it's a big market. You know, there's over five million sufferers of those two types of IBD, Crohn's and ulcerative colitis. And because of that, the the market was worth over 20,000,000,000 in 2023, and it's still growing at near 4% a year, and it will be over 27,000,000,000 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're without getting into the science, they're a pathway that's above TNF alpha, so they actually look into suppress things by going down an immune pathway. But they have real selectivity issues. They have they cause toxicity issues in other organs.

26:49 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 was 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 Alice has mentioned, it it's still a a 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.

27:37 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 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 they're all still very active. So, you know, AbbVie, they've got two approved products, and they're also developing one JAK oral product, which they've got in phase three. 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 and 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 three trials that they're looking at something called IL twenty three combined with another cytokine called s p nineteen.

28:44 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 s one p one inhibitor going through phase three as well. And Takeda, another good example, they they've got approved TNF alpha inhibitors. So a lot 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 the specific issues of reducing inflammation in this manner. I'll just hand over to Alison now just to give you a bit more of a flavor of of what our programs are and what you can expect as investors in the company over the next year or two.

29:35 Thanks, Nigel. Yes. So as I mentioned at the start, I I think that Enfor can deliver on some 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 NuVet platform and the M4 101 program. The partnership with SRI, which Nigel will expand on the next slide, that's also really interesting and a potential value add. So, you know, right now, given the resources available, the best way to add shareholder value is to build out a a really robust data set that supports all of those key benefits that we spoke about, the Nuvec platform.

30:20 And that will allow us to secure platform licensing and partnering deals. Obviously, it's impossible to predict exactly when that will will occur, but we need to build out that dataset because deals are driven by data, end of. The better the data, the more comprehensive and complete the dataset so you can answer all of the questions in those business development meetings, the sooner and better and more significant those those commercial partnerships will will be. So, you know, that that's a key focus for us for the next twelve months. I think focus is an important word, really focused on building out that data set so that we can we can support all of the statements. I mean, obviously, there already is a body of data. We we 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 that work is, you know, relatively cheap and straightforward. You know, we're not talking the same sort of costs as, you know, late preclinical development costs. So relatively cheap, relatively straightforward, but the returns could be, you know, very significant.

31:30 To maximize the opportunity for shareholders, 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 you know, that we want to develop for the Nuvec platform development can be generated using n four one zero one. So we're killing two birds with one stone, very cost effectively, edging n four one zero one towards the clinic as well as building out that that data set. So there's lots of potential for for good news flow. There's potential for a news flow relating to m four one zero one, and the next key inflection point is around in vivo proof of concept. So to basically efficacy in vivo proof of concept, that's being carried out in q two by our partners, University of Queensland.

32:23 And following that, we'll be engaging with the FDA to seek some pre IND feedback on the oral IBD products, and and that, obviously, we'll 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 all the things we've spoken about, I've listed them there on the on the slide. And we'll we will share all of that with the market as we progress through through 2025. 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 those will be with noncompeting RNA therapeutic companies. As I say, impossible to say precisely when the first of those will will drop, but absolutely data driven. So you should be watching as we as we generate that data and share it with the market as we go through 2025.

33:29 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 it basically stands for Stanford Research Institute. They're a very large research driven company in The United States. And and what they have is a system which they call their FOX three m g s targeting system. And what it is it it 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 it will only get taken up by the the selling question. It is, you know, the the element the key point of difference of what they're trying to do.

34:15 And what we've managed to do with them is we've successfully shown that we combine the their peptides to the NuVec nanoparticle. And through experiments, we've shown that we can we can show that that combined NuVec FOX three particle is only taken up into certain target cells. But not only is it still taken up there, 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 onto a particle that's the standard NuVet particle that has also got a FOX three 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 the 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.

35:18 We're looking to actually get them to work with that combined SRI and for Nuvex system. And the 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 written range of these different peptides. And Alice already mentioned earlier, I was gonna talk a bit about back our background IP. We've got a a matter of composition patents for our NuVEX system that's granted in all the major territories, US, Europe, India, China, Japan, etcetera. And by its worrying matter of composition, I mean, the patent is around the structure and shape of that silica mesoporous particle.

36:03 So no one else could develop a spiky structure like this where you've got this mesoporous particle So mesoporous particle, imagine something like a a practice golf ball. So it's a hollow sphere with tiny little pores that give it 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 you can 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 lay major pharma partners' cargo, and together that will allow new IP to produce. So there'll be a three way relationship between the IP. So we're looking to do the work the research work with SRI.

36:51 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 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 we're really hopeful that it will lead us 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 our commercial strategy. We have a proof of concept platform with n four one zero one that we're looking to take into 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 some with viral vectors and lipid systems. So we do know that people are looking for non lipid, non viral systems that help get their RNA treatments and therapies that they're developing into cells and into specific targeted cells.

38:03 So we have these two pronged approach of developing our own assets, and ultimately, there'll be more assets that we'll be able to bring. The NuVex system can be used in a number of different areas. So there's a 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 the business. So, you know, we'll only do that when resources permit, but the the upside potential, we 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 we'll have to partner the first ones because we won't have the funds to do those all into phase one clinical sales. But as we get those funds and begin to develop, we can take our own products into phase one clinical trials, maybe phase two trials, so the values then start to go grow exponentially.

38:51 And we 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, 18,000,000,000 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 n four one zero one program, which is the product for inflammatory bowel disease.

39:40 That showcases all the key benefits of the platform. So as well as doing that work, we're continuing to build the platform. So we as Alice has 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 as, like, a brief reminder, the the 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 q two in 2025. So that's a summary of N4 Pharma, taking you through our technology, our platform.

40:29 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 the market on what we're doing. And we're also gonna 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 n four one zero one program, bit more about why RNA therapeutics. So more educational pieces around the company and the strategy of how we're developing our our platform. So I'll hand you back now to Jake. So thank you very much, everybody, for listening to myself and Alister, and we'll have some question and answers now, I think. Perfect. Nigel, Alistair, if I may just jump back in there. Thank you very much indeed for your presentation this Ladies and gentlemen, please do continue to submit your questions just by using the Q and A tab that's situated on the right hand corner of your screen. But just while the team take a few moments to review those questions that were submitted already, I'd just like to remind you that a recording of this presentation along with a copy of the slides and the published q and a can all be accessed via your investor dashboard.

41:36 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, Alistair, 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. Yep. So why don't I read them out, Nigel? And Yeah. That's fine. Yep. Yep. So the first one is, will you need to raise capital in the next twelve months? Good one. Well, we're not 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, you know, need to raise funds to develop our assets and also to grow the shareholder value. We've talked about what we looked looking to do with our our platform data.

42:27 So we're always looking to grow our share price to allow funds to be raised as efficient as possible, But we're also continuously exploring nondilutive options such as grant funding. And, ideally, you know, when we get our first commercial deal, that will give us a significant source of of funding as well to carry on developing our program. How close are you to collaborations for Nuvec? Alright. Well, you know, our ability to actually do collaborations and the the, you know, and the value of those, as Alas mentioned earlier, is entirely dependent on the dataset 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 n four one zero one in the IBD space.

43:19 And we obviously can't comment on any specific commercial discussions, but we're really hopeful. And we've made it clear in the I think in the presentation that we believe deals will come from the data. We're spending the the time and effort developing the data we're in a strong position to secure licensing deals for the platform. And then we're building on that the the m four one zero one program. So, you know, there's always a risk that, you know, the company is not gonna be able to secure the licensing deals in 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. That's a question about a retweet, actually. It was an article on bowel cancer, Nigel.

44:09 And it says, as as three out of ten cases of bowel cancer derived from IBS, I IBD, okay, so inflammatory bowel disease. I think you mentioned that, Nigel. It's not not not the same thing as IBS, but but IBD. Is it not the case that by controlling IBD, you can reduce the number of bowel cases. And is it also not the case that with n four if n four one zero one can turn off the gene causing IBD, then it can also be adapted to turn off the gene causing bowel cancer. Absolutely. There's a little bit more. Sorry, Nigel. Long question. No. That's fine. Keeps on giving. As Nuvect 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 NeuVac. So I think the question is about our ability to address IBD and how does that impact on bowel cancer.

45:07 Absolutely. Yeah. So, you know, we we retweet this, and we, you know, we we retweet 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 and things that have been developed. And, yes, this work showed that that there 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's going to get bowel cancer at all. But I think they're saying, you know, three in ten people are gonna 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 yeah. The other part of the question that was mentioned that you can do multiple things. So, the 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 Nivet can be, you know, formulated to give specific pathway benefits for two different diseases in 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 we're in oral delivery area. But there's also lots more out there as well.

46:28 Is there a near term update due on ECP one zero five and its orphan drug status? Status? Yeah. 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 one zero five, and it's a product which is delivering an siRNA gene to help treat 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 your 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, early March when they they typically take the sixty days. But with Christmas being in the middle, we're not sure exactly when we'll get our response.

47:37 But as I say, orphan drug status is quite important very important for that particular program. If orphan drug status is granted, is it Enfor's intention to apply for grant funding to take ECP one zero five to clinical trials yourself, or do you intend to partner? Right. Well, as I mean, 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 gonna help in securing either a commercial partner to take that product through into phase one clinical trial trials or an investor to come in to the nanogenics company and provide the funds for nanogenics themselves to take that into phase one clinical trials.

48:32 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 probably answered that during the presentation, but you can cover that again, Nigel. Yeah. So, yeah, the greatest value that we're gonna deliver to shareholders is really ultimately by advancing n 04/01/2001 into clinic and by establishing our platform as the go to choice for people developing RNA therapeutics.

49:22 And and that's, you know, that's where our focus has got to be for the foreseeable future. And partnering either asset of those will will be entirely dependent on the quality of the data and the depth of the data that we're going to be generating. And and we really do believe that the new VAC 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 around for 01/2001. So it leads that across to the platform as well and the platform helping to understand what we can do with n 04/01/2001. But in the long term, you know, 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 twist you know, making that platform available for both other companies and also for ourselves to develop a whole range of of different assets into different clinical trials and treatments.

50:25 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 we've already submitted the application for ethics approval, and they're going to be meeting, I believe, the next couple of weeks. And assuming that gets approved then, we will be able to start the in vivo study itself in in March the 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 the sort of maybe the middle end of q two with the back end, we will have the results of the in vivo testing.

51:12 So this is looking at an animal model to see if we can reduce the amount of inflammation caused by delivering our oral products into the the localized gut and, say, basically reducing inflammation directly. So really exciting data that we're hoping to generate and release in q two. The final question, I think, Nigel, although, I guess, we're we're very happy to address any other questions that come in perhaps with with a written response, Nigel. Is that Absolutely. Yeah. We have some questions we can or can't. Yeah. We'll we'll get we'll get access and get response to all the different questions as we can. Yep. So final one. Subsequent to the 2024 SRI development work, has there been any further interest from potential commercial partners to license and develop NuVac?

52:04 Well, as I said, you know, we can't talk about any any particular discussion, is it? But the SRI work has has already shown that, you know, 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, you know, 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. An 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 ligands. So we're not using SRI with our oral IBD product. We're using a different targeting element there as we mentioned earlier called mannose to target the macrophages.

53:06 So, yeah, the SRI work really does bring to forward the the targeting nature and how easy it is to do that with Nuvec. So I think that's 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, Alistair, that's great. 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'd be great. Yeah. Sure. So as I say, we we've got a we've got a really strong position in the with the technology that we're developing.

53:56 We think it can add significant value. And I would just, you know, advise everybody if they're interested in, you know, following us closely, go on to our investor hub. You'll see this 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 people can understand the company and what it's trying to achieve. And and literally, you know, 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 to work with and interact with investors and keep you abreast of what we do. Perfect. Nigel Alister, that's great. And 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.

54:59 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 Enfor 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.