Poolbeg Pharma (LSE:POLB) — Interim Results

0:01 Good afternoon, ladies and gentlemen. Welcome to the POOLBEG PHARMA PLC Interim Results Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged. They can be submitted at any time using the Q and A tab just situated on the right hand corner of your screen. Just please simply type in your question at any time and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll, and I'm sure the company will be most grateful for your participation.

0:33 And I'd now like to hand over to CEO, Jeremy Skellington. Good afternoon, sir. Afternoon, Mark, and thank you for the the introduction. And a warm welcome to everybody who's attending our interim results presentation this evening. We were just discussing beforehand how quick the year has passed us by, but I think what you see tonight is, you know, the level of progress that we've made at at POOLBEG since the start of the year. And I'll be happy to give that update right now and also give, you know, what we're doing planning forward and the the near term milestones or catalysts for the company. So the usual legal disclaimer as a public company. And I'll progress now and talk again about, you know, the the the background to POOLBEG for those not familiar with us. And, obviously, we'll have existing investors on the call as well who are quite familiar, but good to get an update.

1:22 So from POOLBEG PHARMA standpoint, we spun out just, over a year ago from Open Orphan. They had acquired a company, h Vivo, who had focused in on clinical trials around viral infectious diseases. And so we spun out the biotech, the pharma assets from h Vivo into POOLBEG. And last July, we raised July 2021 raised 25,000,000 on the a market and are progressing these initial or original pharma products. But also we've in licensed brought in programs, I'll talk about later on. We have a unique capital light model. And, as you see later on, we were actually very spendthrift. We've 18,900,000 left in cash at the end of July at the end of June. Apologies. So you'll see that, we are very judicious in our spend. And the goal of POOLBEG is to develop, or get early human clinical data with our products and then partner with pharma. I'll talk about that later on, the the business model, and that'll be coming. We'll be very active in the near term when it comes to business development activities.

2:26 So let's say we're fully funded. No need for further cash. We have 18,900,000 in the bank at the end of June. Long term shareholders, our chairman, our wonderful chairman, has 7.28%, and SHROLBEG's vested management, declaring they're over, 5% to 5.13. We're quite similar to a German company Evotec who started in clinical trials, and they too developed products with pharma and out licensed pharma. And, you see they go across many different diseases. We're very much infectious disease focused, and I guess no better time to be in the infectious disease market as it's expect expected to grow rapidly 250,000,000,000 by 2025 across therapeutics, vaccines, and diagnostics. And I think we've all learned a lesson about how ill prepared we were for COVID nineteen. So what you'll see is that pharma are very much focused on being better prepared for further future pandemics and, dealing with current and existing infectious diseases.

3:21 The team itself, the management team, were very experienced. We have created over $1,000,000,000 in shareholder value across the various companies that we've worked with. And, again, very proud to be on board with, Carl Friedler, our founder, along with, Ian O'Connell. Again, we have a very experienced team behind this, you know, to drive POOLBEG forward. And so we IPO July of last year for thirteen, thirteen and a half or so months later. We've made a tremendous amount of progress. We're expanding our portfolio of assets, so we're building out our our pipeline with our internal programs and balancing that with external in licensing as well. And again, it'll be a self funding business model where we'll out license early and often with pharma and fill their pipelines. And then they can take it forward into the longer, more expensive phase twos, phase threes clinical trials, and ultimately on the market. And from that, we generate revenue from those those deals.

4:10 So we're gonna focus on European North American rights. I think that's where we get, you know, significant revenue generation, but we're also open for partnering across Asia, whether it is Chinese rice or Korean rice, for example. So we plan to be a one stop shop for pharma to in lies to to license infectious disease assets. So that's the POOLBEG strategy in a nutshell. Again, this is a graphic just describing how we do this. We are capital light. So each individual program, we spend no more than 2 or 3 or 4,000,000 on the programs. And again, that's get it to human proof of concept studies. And, you know, from my experience, twenty years in the industry, pharma, they they love human data. They do in license earlier stage products. But if you've got human data, that really checks a lot of boxes and gets deals done quite rapidly. So we plan again, fortunately, in infectious diseases, these low cost clinical trials. And I think, fortunately, as well, you know, in a, you know, post COVID nineteen world, there's a lot of nondilutive funding options here. So we can have our programs funded externally by government bodies like the NIH, for example, and, in The US. And, they funded to bring it forward because they're into that global unmet need and meeting that global unmet need in infectious diseases.

5:22 Again, for infectious diseases, we can get early human efficacy there quite quickly. These are not long, you know, oncology, you know, cancer trials that may take two, three, four years. These are quite rapid to get our clinical trial trial. And as you see with our lead program POLB zero zero one, we're currently running a challenge study right now in The Netherlands, and we'll have data by the end of the year. So again, this moves very, very quickly. And once we have this data in hand, we then partner with pharma. So again, they're looking to bring in programs into their pipelines and, build them forward, you know, fill their, you know, development pipeline so they can achieve their revenue goals, in the future. And they look externally to companies like POOLBEG to acquire our license assets that they can then develop develop. So, again, the licensing terms, the deal terms that we'll get from pharma that will fund and we'll reinvest in our own pipeline. So it's a nice cycle.

6:14 As I say, it's gonna self fulfilling where we'll and, again, the plan is to develop multiple assets at once. So we'll have a nice little staggered pipeline where we'll be parking programs regularly. And again, for the audience, just to highlight the deal terms that are on offer from pharma when they do deals with companies like POOLBEG is that these can be quite attractive. And I just highlight a few of these, but most recently, back in May of this year, GSK acquired Affinavax, who had a pneumococcal vaccine as well as a vaccine platform in phase two, which is the next stage from from POOLBEG with $2,100,000,000 upfront and then downstream of 1,200,000,000. So these are significant, deal terms that pharma are willing to pay to get the right products into their pipeline. And in our directly in our space, Reviral, who have a program in respiratory syncytial virus, RSV, and you'll hear a little bit about that later on. Pfizer acquired this company earlier this year for 525,000,000 upfront for their, their vaccine program.

7:13 Again, as I say, pharma are looking for assets to acquire, to in license, so they can add to their pipeline. And again, POOLBEG plans to be their partner of choice in the in the future. The last deal I'll flag down the bottom, just to highlight that some of the pharma companies like to do just territorial deals. So Bavarian Nordic license their RSV program to Chinese company Nuance. So again, POOLBEG could do something similar, licensing the the Asian or Chinese rights to individual companies. So we have potential to say it's a numerous, you know, options for for revenue generation in the near term around our programs. I did talk about, you know, I know we're just starting September. I do hope everybody had a had a good summer, but Mark and I were talking how quickly the year has passed. But again, very proud looking back from a POOLBEG standpoint how much we've accomplished in in that short eight months.

8:02 So our financial operation highlights for this first half of the year is our lead program POLB001. We did numerous activities where we signed our clinical trial agreement. We have completed GMP manufacturing to allow us to go into human clinical trials, received ethics regulatory approval to run that clinical trial and started the study back in July. And again, this is heating with our IPO milestone. We stated at our IPO that we will push rapidly, have this in the clinic by summer of twenty twenty two, and again, happy to say we've done that. So we're hitting our milestones. Again, an excellent team behind me here. And again, because it's infectious disease focus, we'll have our initial data by the end of twenty twenty two demonstrating efficacy, you know, the proof of concepts that pharma likes. So again, we're moving well with POLB001.

8:52 And as well as data, pharma likes to see intellectual property behind the product. And happy to say that we've got protection for POLB zero zero one in severe influenza out to 2038. And we've got The US patents granted on that back in earlier this year back in April. So, again, looking at our other pipeline products, I'll talk about later on POLB zero zero two. We've got patents granted there in The US and Europe earlier this year, so a nice operational highlight. And, again, we are moving forward in artificial intelligence programs to analyze very unique datasets, this human viral challenge study dataset that we licensed from from OpenOrphan. So we've got an RSV data analysis ongoing at one three, an influenza data analysis going on with, and I'll talk a little bit about those later on. So again, good progress there to get those deals in place and begin the the collaborations.

9:45 Again, building on our pipeline, we've got in license POLB zero zero two from the University of Warwick, a broad spectrum RNA based immunotherapy for respiratory viral infections, and POLB zero zero three. We've completed our diligence. We had an option for this program. It's a vaccine against a bacterial disease called melioidosis, and now we're working on finalizing the definitive license. So I hopefully will be able to to wrap that up very soon, again, add to our pipeline formally, and then move forward in development. And a reminder that we're very well capitalized. I know these are, you know, challenging times for many companies where, you know, because of our IPO last year and our capital light model, we're very well capitalized with a strong cash balance of 18,900,000. And, we'll continue to have low operational cash burn. We have significant resources to build the pipeline continually, and then we are exploring nondilutive funding. If we can get external nondilutive funding to move the programs forward, you know, happy to do that. And I think in infectious diseases, we're at the perfect time to do that.

10:44 This is our pipeline or activities in a in a one slide nutshell. So, again, it's it's very exciting. We're hitting many different areas. You'll see we're hitting therapeutics. We're hitting prophylactics. We're hitting vaccines. And, again, we've got platforms to to move along. So, again, I'll talk about each of these individually as we go along. But POLB zero zero one severe influenza, so I started a challenge study. So we look data as an upcoming catalyst. We'll have data coming out at the end of the year. And, again, we begin our out licensing discussions there after we demonstrate that proof of concept. For zero zero two, we're kinda working on development plan with our collaborators, and that's, again, ready to move that forward. We're lining up, you know, manufacturing, for example, to get that going, and I hope to get that, true. And, obviously, you know, the the goal is to get that into the clinic quickly. And, again, zero zero three, complete the licensing and development plans and move that forward.

11:34 So these are three individual products. When we look at our platforms, I just wanna highlight that we can get many different pipeline products coming out of each and every platform. So the AI deal we did with one three around RSV, that's progressing well. We had a joint steering committee last week. They updated us on that progress and continual discussions back and forth. So, again, we have a very unique dataset. So we expect to have results by the end of twenty twenty two on that. For the influenza drug analysis, that's ongoing as well. Results expected into next year. And, again, they have a different approach. And for each of these, we'll have new drug targets that comes out of this analysis and ultimately new drugs that then we can bring forward into RSV and influenza for for each of these analysis. So, again, it could be multiple drugs that that comes out of each of these collaborations.

12:24 And on the bottom then, very excited about our oral vaccine delivery platform. Again, we're all very familiar with vaccines and injections in our arm, but I think the next wave of technologies will be looking at oral administration of infectious disease vaccines. And that there's many multiple advantages to that I've talked about later on, but we have an exciting technology there that's micro nano encapsulation that protects the vaccine when you take it orally. So, again, working through that. Other programs or vaccine discovery viral predict, I won't touch upon tonight. But I do wanna flag that we are looking at, other in licensing opportunities to build our pipeline, again, get that early human clinical data and partner. So we're in very good shape. We've been, as I say, very busy, very active, but capitalize is the key thing. So we have a a long runway for the the 18,900,000 we had at the end of June.

13:14 So a slight pause. I just wanna talk about each of these individual programs as we go forward right now. So our leads program, our lead asset POLB001, a clinical stage potential blockbuster immunomodulator for severe influenza. And this is the one that, let's say, we inherited from from open orphan when we demerged in July of last year. So severe influenza treatment, as I say, started our LPS challenge trial earlier this year. This has the potential, you know, for for transformational treatment. There is nothing out there for severe influenza right now. We've all heard of influenza vaccines, which, you know, prevents diseases. But if you you know, they're very weak every year, they change. And if you happen to get influenza and progress a severe influenza, there's nothing out there for that. So what happens is that the immune system responds negatively to the presence of the virus and actually goes into a cytokine storm, which causes a lot of lung damage, cell damage, vascular damage. So where you have got a a very exciting program to, to stop that inflammation and, progress that forward.

14:19 So it's irrespective, irregardless of viral strain. So this is blocking the immune response, not the virus in that particularly. And, again, we see this as a very attractive shelf stable potential for stockpiling and orally administered. So, again, very kind of exciting, very great potential for a significant unmet need because the the world is kind of recognizing that in a post coronavirus world that the next pandemic could indeed be influenza as we haven't had much exposure to that over the previous coming years or previous years. So, again, we're we're looking to, to move that program forward. We have worldwide rights for the molecule itself and patent protected out to 2038. And we're expanding our intellectual property beyond severe influenza, so we've got active discussions with our intellectual property attorneys to move that forward. Because we see blocking p 38 can have multiple, can have effect on multiple different diseases. So, moving that forward there.

15:13 So, again, we're as I say, severe flu drives this p 38 pathway, and POD zero zero one blocks that, blocking the cytokine storm and blocking the severity of disease from there. And, again, a large market, 275,000,000, the the analysts forecast, in Europe and The US, and potential to go well beyond that. So, again, we're making great progress on the on the the program itself. We'll have early efficacy data by the end of the year, and then the plan is to to out license soon thereafter. And, again, I just wanna talk about a little bit you know, we are capital light, but we are derisking programs. We bring in programs that, to a certain degree, have already been derisked. And as an example of this, the lead molecule, the POL zero zero one, has already been in safety trials in humans. So we know that it's safe, and we know that it's well tolerated. And, again, moving that into LPS studies, again, we know that there's a very good safety head box has been checked. And, again, looking on the right hand side, we've done some work ex vivo outside of the body, and we know that it blocks the pathway that we wanted to block. So we've significantly derisked the program ourselves.

16:14 So we have a good chance of success. So we expect, you know, good data coming from the LPS challenge study by the end of the year. So, again, very excited about that. And as I say, there's, you know, potential for treatment of severe influenza and other diseases as well. So we'll explore those those avenues. A brief slide, I won't go into detail here, but here is the LPS trial designed for those who are so interested. So this is to evaluate POLB001 on the inflammatory response following intradermal, that's under the skin, and intravenous, you know, in the veins, challenge with lipopolysaccharide. And this is a bacterial fragment that the body recognizes as foreign and drives an immune inflammatory response similar to what happens if you're infected with influenza. So the body recognizes the influenza virus as being foreign and drives an inflammatory immune response. So, again, we see this as a surrogate. So this is ongoing. As I say, we started back in June. Sorry. Back in July, the volunteers have been enrolled over the last number of weeks, so the study is ongoing.

17:15 So we're gonna do three different doses of zero zero one and twelve volunteers for each different dose. And so the patient profile are healthy volunteers and no prior of inflammatory diseases. The design on the bottom I won't go into detail, but it's quite detailed in that we're analyzing three different drug doses. But on the right hand side are the key data that will come out, the endpoints. You know, how the skin responds, we have imaging set up to do that. The blister is where we look at the immune infiltrate, the different cells that respond to the treatment. And again, safety tolerability, of course. And then on the bottom, we're looking at the response of the immune system down to the molecular level. So we're looking at the cytokine responses, the c o CRPC reactive protein, and obviously looking at safety and tolerability. So we'll have a very interesting complete dataset at the end of the year to begin our our partnering discussions with pharma to move this into a severe influenza setting. So again, very happy that we're hitting the milestones that we set at IPO, that we start our trial this summer and move it from there. So again, that's, you know, again, a terrific milestone for the team to begin that clinical trial.

18:23 We've got others coming behind us, other exciting therapeutics. POLB002 is a first in class broad spectrum RNA based intranasal immunotherapy for respiratory viral infections. So again, in the same category as influenza, but importantly, we're also targeting the eighty five percent of these non influenza respiratory viral infections. So again, a great potential for a marketplace for this. It's got a late preclinical data package that we're excited about. And again, we pursue there's very few treatments available for for these type of diseases. So the data package we have, we're very excited about. We're ready to progress this forward. As I said, the deal was signed earlier this year, so a lot of discussions going on about the transfer of of data materials, etcetera. So, you know, one of The US key opinion leaders has stated a broad spectrum antiviral that gets around the fact that we don't always know what we're treating would be game changing. So if you and there are various settings like, you know, elderly old folks homes, for example, or an army based setting where if, viral disease is catching, we can have this kind of prophylactic, you know, where your treatment in advance of getting infection or indeed therapeutic where we can block the infection from there. So again, very exciting program that we're moving forward. This is just a a snapshot of of the datasets here. On the right hand side, this kind of shows that has a very potent effect on blocking influenza a response in a in a model of influenza.

19:48 So, again, quite compelling where it kind of you know, fully protects against influenza. There's been twenty plus years of work at the University of Warwick, enjoying working with Andrew Easton to move this forward. And again, this would be a single dose intranasal administered. So again, nice and simple and straightforward. We can address a lot of markets through this approach. And again, it can actually treat the disease if you have it, but block the disease if you don't. So again, a dual purpose that we're very excited about and again across influenza and other respiratory viral infections by triggering the mucosal immunity in the nose. So late preclinical, doing some work and scoping out for around manufacturing, etcetera. And again, importantly, as I mentioned earlier, we've had The US and European patents granted earlier this year. And again, patents are are key to, you know, to to advancing and and adding value to the program. So broadly, just as a an overview picture, respiratory viral infections affect annually five to twenty percent of the global population.

20:46 There are three million plus annual deaths. It is a top five global cause of death, particularly the very elderly and the very young. And again, potential for pandemics. So again, for this, a potential for stockpiling and have it ready for for future infectious diseases. So again, very excited about that program as we are about POLB zero zero three. And this is a vaccine against bacterial disease called melioidosis, and we took an option for this program, back in December 2021. We've completed our diligence, so we're progressing now to, you know, actively, you know, bring this into POOLBEG and to move it forward. So we've had some really good discussions around development plans, etcetera, with, with our collaborator, professor Siobhan McLean. So melioidosis, many of you may not have heard. It's a tropical, subtropical disease.

21:33 But interestingly, due to climate change, it's actually spreading from these, tropical, subtropical regions. It's recently been identified in the grounds in The US, quite surprisingly, and in countries like Nigeria, for example, where it hadn't been, seen before. The bacteria is Burkholderida pseudomelii. And, again, it's quite a tough antibiotic resistant bacteria. There's nothing out there for million doses, so there's a significant unmet need. And you'll see here a hundred and sixty five thousand cases annually, fifty four percent fatality, and again, zero vaccines. So this is kind of a high unmet need. And I think from a POOLBEG standpoint that there's a there's a great need for this, particularly as it's on the US Center for Disease Control designated tier one biothreat. So they see this bacteria because it is so robust that it has a potential as a biothreat.

22:26 So they are, you know, looking for, you know, opt out there that they can they can use N and D fund to to have vaccines available. There was an outbreak recently from in The US, so they are on high alert in The US. This was, you know, quite, you know, unfortunate through distribution of of a a fragrant spray. And it shows how robust the bacteria is that is able to survive in these in these new these floral, you know, design sprays in the room and survives it does. You know? So, again, creates challenges, as I say, you know, fifty four percent fatality. I always like to insert a little bit of data, the scientists that I am, but as you'll see on the right hand side is that there's a seventy five percent survival, in this, your model of melioidosis.

23:12 So having the vaccine versus not having the vaccine. So you'll see it has a robust immune response. And I know you've probably heard, through the, the pandemic of these t cell responses and b cell responses. B cells responsible for antibodies, for example. So, again, we see in this, in this animal model that there's a robust response in both senses. So we are triggering the immune system, and we are seeing benefits. So, again, this able enables us to move forward with confidence that this is a vaccine now that's worth pursuing, that the the the preclinical data is, is of sufficient interest and and sufficient validity. Interestingly, from, from this standpoint, there is a a skew in the in these tropical, subtropical regions to patients with diabetes are particularly susceptible.

23:57 So we see that there's, you know, there's different clinical trials we can run and, again, get identified, get positive clinical data, you know, focusing in on diabetic patients, for example. So, again, it's a subpopulation we can pursue. So, again, very exciting program where there's nothing else out there for melioidosis. So we feel we have a little bit of an age. And we won't stop there. As I say, we're a very ambitious, a very aggressive biotech company focused on infectious diseases. Through our option agreement with University College Dublin, we also have options to these other bacterial vaccine candidates a little bit earlier than than melioidosis, but some of them are coming up with kind of, you know, significant unmet needs and interesting vaccines to the stand. And particularly the the VTech, this is a diarrheal disease, E. Coli, that again has issues amongst kids and the elderly.

24:47 And for cystic fibrosis, there's this Pseudomonas aeruginosa vaccine that we're exploring as well. So, again, we have options to these. If the data comes forward that we like, then we're happy to to do deals in that space. So that's our pipeline as it were. So these are active programs that are moving forward on a drug candidates or a vaccine or a, you know, therapeutic basis. We're also looking to build our platforms. So these are kind of platforms that can provide many different types of new drugs into our pipeline as we move forward. And just a couple of slides on our oral vaccine development platform. So as I say, there's a there's only a a very few number of oral vaccines out there. Polio vaccine may be the most famous, but there's other unmet needs to, you know, to get oral vaccines to drugs that are maybe more typically injected.

25:37 And what you need for this oral vaccine

25:39 is a combination of an an adjuvant, which stimulates the immune system, an antigen, which you can zoom in and zone in on the infectious disease of interest, and then you gotta protect this encapsulated so it's protected from the stomach acids and the stomach enzymes that degrade everything else you ingest. So we have interesting exciting technology on the bottom front for encapsulation, an antigen, as I mentioned, amyloidosis with University College Dublin and collaborating with, you know, Trinity College Dublin around adjuvants. So these we're putting the three of these together and coming up with a platform that we can apply to many different diseases. And just a brief slide on the anabiotecology. So, again, what we're trying to do here is trigger mucosal immunity. So this stops infection at the site of infection. So you're triggering immune cells where an infection can occur. So you wanna do that in the gut and other mucosal areas. So that actually prevents the pathogens from infecting the body. So, again, they've generated proof of concept data using this technology for other proteins, for bacteria, even for peptides.

26:44 So we feel this has a great potential to, you know, for encapsulating both the antigen and the adjuvant so that we get multiple different vaccine candidates coming from this platform. So this enables us on the bottom of this slide just to highlight that enables significant or several advantages. Enables max vaccinations, avoiding needles. There is a bit of a, you know, needle hesitancy. Avoid vaccine hesitancy because it's so easy to take. Easy administration. You don't need a physician. You can do it from home. And I think importantly, cold chains So you don't have to ship these liquid vaccines at minus 80, for example. So you can have them in a pill format and then ship globally. So there's great potential for for this platform that that we're working on. And the last stage I'll talk about now is our very interesting and very unique artificial intelligence analysis of the respiratory viral infection challenge study data that we have, and it's very unique. Nobody else has this data. So we've signed two deals, two collaborations using AI to, to work through the data we have.

27:47 I think we've we've all heard in the news how AI is the way of the future. Well, in the future, a lot of drug discovery, drug development efforts will use artificial intelligence. We're a little bit overwhelmed by data at the moment, and I think using AI and super, you know, computers, high powered computers to analyze the various datasets will go a long way. In number one, derisking programs that, we can pick the right targets, we can pick the right drugs to move forward with so that they'll be successful in the clinic. And then number two, we'll shorten timelines. We'll be able to kinda move forward quicker because we've identified, for example, patients that would benefit first. So you can see here that there's a, you know, a rapid exponential growth in the the kind of investment in AI. And, we're very happy to be part of that, you know, part of the contribution using our data in the AI spectrum to to analyze our data. We have two deals ongoing right now, two collaborations around RSV with colleagues at one three biotech, and that's to identify new drug targets and treatments. And stage one has been completed, and now we're building into that model optimization of it, you know, and ultimately identifying drug targets that cause our drive, RSV, and the number two drugs that will block that, that response. And I just graphically, I just wanna spend maybe thirty seconds just to explain what we're doing and why it's so unique and I think really important. So what we have right now is clinical data that's generally unstructured.

29:14 This can be from 60 people who contributed in the in one trial and 72 people in a second trial. So we've got all their data around their gene expression and protein expression, signs and symptoms, mucus, for example. So the computers analyze all of this data and come up with a a potential disease model. They look for signatures, and these signatures are what what genes are ex expressed, what genes are upregulated or downregulated, what proteins are present or not present. And, again, ultimately, comes out of that analysis is targets. So these are new and novel targets that drive disease or protect us from disease. So importantly, it look it's looking at both sides of the the equation. So ultimately from that, then we wanna get, you know, the best targets to work on and then, of course, drugs that will block or enhance those targets. So that those studies are ongoing. For the RSV, we expect to have outputs by the end of this year. So that's how quick the AI analysis can occur. And then with the influenza data working with Cyreason who already have existing deals with the likes of Pfizer and Roche and Sanofi and POOLBEG.

30:18 We expect to have outputs into, you know, maybe q two next year where we'll be able to have new targets around influenza. So again, exciting collaboration for for POOLBEG. And as I say, using that unique dataset of of data that we have acquired or from or inherited from from open orphan. So again, nobody else has this dataset. So my last slides before again, I'll I'll take questions. Happy to take questions are what we see as a a compelling investment case. I think infectious diseases, they're they're not going away. They will be around for for a long time. Our near term POOLBEG specific, value inflection points is that we'll have data from the LPS channel studies by the end of the year. We'll have outputs from the RSV AI collaboration.

31:05 And then by the end of this year and then next year, we'll have, you know, data from the the influenza programs. And we have other, you know, newsworthy items in in the interim. And, again, just highlighting or flagging how experienced the team are, where many, many years in the in the industry, driving shareholder value over 1,000,000,000. And I think we're focusing now. We're pivoting a little bit to be focusing on the the outlicensing. We've already, as I say, kind of initiated some some discussions, but we'll be announcing a new hire, head of business development very soon and and a global clinical director because we're getting busier and busier. And with the new clinical programs coming down the pike, we were expanding our team to fill that need. Flagging again point three that we're very well capitalized. Again, the capital light model is working very well in this situation.

31:52 We've low operational spend. And again, we continue to, you know, enhance, let's say, our, you know, underlying finance finances with non dilutive funding. If a government body, for example, or a charity, nonprofit is willing to fund our different programs in infectious diseases. We're very happy with that, and we're actively pursuing these nondilutive funding grant opportunities. And then lastly, infectious diseases. As I say, it's not going away. There's more focus in this space. It is expected to grow by to 250,000,000,000 by 2025. And we now know that big pharma, maybe after many years of neglect, are turning and pivoting to kinda start focusing more in infectious diseases and in licensed programs to give them a jump start in the space. And they look to companies like POOLBEG for our programs and for our assets. And from there, then we do in licensing deals and generate our revenues.

32:44 So I think we're very well positioned as a company. We've worked really hard since IPO thirteen or so months ago. Again, as you've seen, we've been quite you know, we've progressed a lot of our programs in the first half of this year while maintaining the light capital spend. So again, it's a very exciting future for POOLBEG. I think, as I say, we're we're at that pivot point now where we're expected you know, we expect ourselves to kind of grow and progress and get deals done as well in the future. So exciting times. And, you know, glad to have existing investors on board and, of course, new investors as well. As I say, I think it's an exciting time to be an investor in POOLBEG. So thank you for that and very happy to take any questions you have right now. That's great, Jeremy. Thank you very much indeed for updating investors this afternoon.

33:29 Ladies and gentlemen, please do continue to submit your questions using the Q and A tab just situated on the right hand corner of your screen. That's why Jeremy takes a few moments to review those questions submitted already. I'd like to remind you that recording of this presentation along with a copy of the slides and the published Q and A can be made available via your Investor Meet company dashboard. Jeremy, I've given you no time at all. Just quick quick swig of water, and and you're back in it. But as you can see, you've had a a number of questions from investors today, and, obviously, you received a a number of presubmitted questions. I wondered if I may just hand back to you to read out those questions and give a response where it's appropriate, did you say? Yeah. I'd I'll I talked to the the one that comes up very frequently in the first time about me personally buying shares. And I I share the frustrations because I've been an insider for so long and because, as people have seen with the RNSs that we released as frequent news flow, we've been guided by our, you know, our nomads, you know, our brokers that I you know, that I cannot buy shares because I'm an insider. Now I will say my own personal broker has cash in my account.

34:29 So when I get that thumbs up that I can buy shares, I will buy shares. It's, you know, it's it's as simple as that. But it's a you know, so the only as I say, the the only holdback is the fact that I'm such an insider because we do have newsworthy items, you know, coming down the the pike and, you know, announcing very regularly. So I I share the frustrations, you know, as you say, think I I I believe in in in the company. I believe in our strategy. I think, you know, I I we we I say I I was gonna say I, but we as a team have worked really hard over the last number of years to to build, you know, to the the company in licensed programs and move it forward. And, of course, you know, happy to buy shares when I'm allowed. So, you know, as I say, I just need to pick up the phone and call my broker, you know, that, that the permission has been granted. So that's the first question getting that out of the way. I think, there's a question here that was presubmitted about share buyback.

35:17 I think, you know, we're we're fortunate to be in such a strong financial position right now. Mean, the the share buyback was, was approved by our board earlier this year. But I think what we're thinking right now is from a funding standpoint is that we've got an exciting pipeline. We've got exciting platforms of our programs. We are looking externally at other programs to to bring in as well. And as I say, invest in a capital light model to get that that early human data. So I think those funds that we have for potential share buyback are probably best placed or positioned on expanding the pipeline and advancing. Because as you've seen, you know, we'll you know, from the deal terms that we could potentially get with with PHARMA, you know, we'll be, you know, seeing but that'll be a significant revenue generator, I think validating the business model for POOLBEG as well. So I think investing in the pipeline is probably best right now as opposed to to our own existing shares. So I hope that I hope that makes sense. But but the option is there, as I say, we have approval, but I don't think there's a need for it right now.

36:15 Okay. There's a question here from Robin D. Approximately, how much will the phase one challenge study of POLB zero zero one cost to undertake? Again, appreciate that. You know, obviously, contractual reasons, I can't go into detail, but it's, it's not that expensive. These are 36 healthy volunteers. The trial the com the company that we run it with, CHDR, run these very regularly so they have their own efficiencies to run it. So it's not in the multiples of millions. You know? We have again, we've kinda kept the negotiator hard to keep the cost down, you know, quite low. So very manageable. We've always said that each of our programs will spend maybe 2 to 3 to 4,000,000 on each program. And for zero zero one, we're certainly on track for that, you know, keeping the spend quite low on that. But so that's one question. There was another pre submitted question about the share price. And again, maybe like my my own share partners, I share the frustration. These are very, you know, challenging, difficult times.

37:10 It's it's a puzzle for us. We're executing on our strategy. We've got 18,900,000 in bank. I don't think that reflects the value of the company. Certainly, the share price doesn't reflect the value of the company. We do, as I say, from a from a POOLBEG standpoint, the best we can do is just to continue executing on the strategy, hitting our milestones, and we'll continue to do that. So we you know, we're we're, you know, expecting the market will recognize that. I understand there's if you use the term choppy waters, there's a lot going on outside of POOLBEG on a, you know, a global, frame, global standpoint, you know, global uncertainties, inflation, you know, know, interest rates, etcetera. But we're gonna continue to execute on our strategy. And I think, you know, at the price right now, we're a very good, very good investment opportunity for for those interested. So, again, we're frustrated, as I say, but, I think that, we'll continue to stay focused on our mission and on our goal, driving, you know, the science, driving the programs forward, and ultimately getting this to to patients that need it most.

38:09 And that's the true value in the company. I think that the other share price then over the next while will reflect that. Let's see here. Robin d again. Another question. There are a number of other vaccine candidates other than melioidosis that were under option correct. Yes. An update on those. I did mention in the in the presentation that we're focused on melioidosis right now because it's much further along. Yeah. Professor Siobhan McLean, her team are working on the others. We do like the the E. Coli. There's a large unmet need there, these diarrheal diseases, and that I mentioned, the cystic fibrosis program as well for pseudomonas aeruginosa. I I think these are quite interesting. Earlier stage, so we're kinda monitoring them closely. But because we have an option, as I say, we can pull the trigger when we, you know, when we deem, you know, we that'll be, you know, the right time to do that and bring it into our pipeline. Pipeline. We don't wanna go too early because, as I say, we've got other programs further ahead, and we wanna get it into the clinic as quickly as possible.

39:05 Alright. Let's see here. Can you give any guidance on likely dates for starting clinical trials on zero zero two, zero zero three? Again, appreciate that. Zero zero two, we just in licensed earlier this year from University of Warwick. So we're kind of into the development plan. We it did came at a very impressive, very large dataset. So we're working on the development plan and moving that forward. So, you know, we're kinda looking at manufacturing vendors, for example, to get that going. So, you know, we get we do plan to move that forward as quickly as possible. And I do mention the the the zero zero three. As I said, that was under an option. Now it's under a license, so we can kinda get our kind of arms around that. We have been preempting, again, talking to manufacturers. Again, we need GMP, good manufacturing practice manufacturing to allow us to put this into humans. So we've had discussions already with GMP facilities to to get that moving. So we are kind of moving in the background. And what I will say is that we'll update the market in due course.

40:00 You know, whenever anything, you know, milestone is coming or milestone has been achieved, we'll update the market, of course, in that regard. Okay. Alan, Jay, just reading here is a question. Are big pharma or is there a target pharma currently in the wings to partner with zero zero one? I I mentioned earlier on that, you know, what pharma look for from a partnering standpoint is data. So once we have the data now we're laying the groundwork. As I said, they're aware of POOLBEG, they're aware of the work we're doing. And once we have that data in hand, which again, by the end of the year, we should we should have the LPS challenge data. That's when discussions will start in earnest. But I mentioned we we've just recruited, starting next week, a new VP of business development. So he'll be pushing forward quite rapidly on our partnering fronts. And I think, as I say, we're looking we don't have a we we will cover base. We don't have one farmer. We'll cover all farmers. And, we look, as I say, at Asian rights as as potential and, you know, whether we, as I said, do it territorially so that we, in fact, make the pie bigger, you know, that we'll get a revenue.

41:04 So, again, we're that's coming in the future. So looking forward to that. Let me see here. How long does POLB have access to the challenge study data supplied by OpenOrphan? And is there any plan for this to be extended? Good question. The license when we demerged from OpenOrphan was thirty months. So we're thirteen months in, so we've got seventeen to go. And, yes, I mean, there's the potential to expand or extend if we need to. We are looking at the other trials that go on on, you know, those who are familiar with open orphan, and I know there's an overlap in investors. They run trials, influenza, RSV, HRV, human rhinovirus. They've started recently a malaria, challenge study, so we could potentially have, data from there. And, last year, as you know, a lot of the they they published data on COVID nineteen.

41:57 So, again, you know, variants are changing. So but I'd still like to to get that data analyzed. We talked to one of our AI partners last last week about potential to expand. But, yes, I mean, there's a potential to to extend that license if we need. So we have seventeen or so months left on that, so I will keep a close eye on that. Question here from Simon c. You mentioned Evotec. Are there any UK competitors, and what differentiates you from them? Not in The UK as I know. EVATEC, as I say, they started off as a clinical company, as a service provider company and decided to build their own pipeline, you know, take their expertise, you know, as POOLBEG is doing, progress programs, you know, forward through, you know, preclinical or into the clinic and then partner. So they've been very successful. So a similar business model to us. We are infectious disease focused. Although I will say we're looking at other, say, opportunistic, you know, programs as well, But not that I know of in The UK, but I think if we can, you know, you know, mimic Evotec, you know, their their, you know, share price are in the the or sorry.

42:58 Their market cap is in the, you know, the $3.54000000000 range. I think we we'll be doing very well. And, again, as I say, the frustration on our our side is, we we see ourselves as having greater value than the the stock market, the share price reflects, but we'll continue to to focus on on growing value and and executing on our strategy, hitting our milestones. I would say, you know, and then, you know, we'd expect the share price to improve from there on. Robin, have another question? Appreciate all these questions, Robin. If you find a development candidate from the AI programs, would these be likely to take priority over existing r and d programs if there are molecules that wish there's already some clinical experience? Fantastic, Robin. I think, Robin, you know, you get the business model. And I wanna take a a step back to POLB zero zero one.

43:46 Our colleagues at HVIVO started analyzing the the the influenza viral challenge study data twenty sixteen, twenty seventeen time frame. Took them two to three years to identify p 38 as a target and went and in licensed molecules this time from a Spanish company, POLBEG, and then moving that forward. What HVO did in that kind of two to three year time frame is gonna take us, you know, just a few months. And that's where, as I said, we'll have identified new novel targets just like they did p thirty eight and interesting molecules just like POLB zero zero one. So we see, yes, there'll be a, you know, potential to bring programs in. We will prioritize, you know, if we feel that there's a molecule we bring in that is ready to go for challenge studies, you know, we we can. As I say, we have the potential to, you know, to push that forward. But as I say, the goal for the company, the strategy for the company is early human clinical data. So if we can get that with a new program, all the better. But I I you know, one of the things I'm looking forward to most is, you know, an embarrassment of riches. I think with RSV and with influenza, we could have lots of exciting comments or lots of exciting programs that we're able to bring in and in license and put into challenge studies very quickly.

44:59 Prioritization will be key, Robin. And I I appreciate the question, but we have flexibility. And, again, a reminder, like, have sufficient cash and we have a capital light model so we can, we can test, you know, several of these. But, again, the proof and I fully admit the proof will be the partnering that comes at the end of it. So as I say, we're very focused on that element right now. You know, again, mentioning again, we're we're bringing in the head of VP of business development with many years experience in the industry to to drive that forward as well. So, again, again, appreciate all the questions. I think we're we're kind of running out of time here. If there are additional questions, again, we we'll we're happy to answer those afterwards. But we appreciate your time. And as I say, we we at POOLBEG, I'm very proud of the team that I have behind me here who've done excellent work to advance the company, advance our programs. But as I said, I still feel to me where where, you know, we we have a long way to go. There's a there's a lot of, you know, opportunities to to drive value in the company with the numerous programs we have. So, again, I thank you all for for your time this evening. And, again, if there's follow-up questions, we're happy to to address that in the future.

46:01 That's great, Jeremy. Thank you very much for updating investors today. Can I please ask investors not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order the company could better understand your views and expectations? This may take a few moments to complete, but I'm sure will be greatly valued by the company. On behalf of the management team of POOLBEG PHARMA PLC, we'd like to thank you for attending today's presentation, and I wish you all a very pleasant evening. Thank you very much.