Poolbeg Pharma (LSE:POLB) — Investor Presentation

0:01 Good afternoon, ladies and gentlemen, and welcome to the POOLBEG 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 using the Q and A tab just on the right hand corner of your screen. Just simply type in your questions at any time and press send. The company may not be in a position to answer every question received during today's meeting. However, the company can review your questions, and we'll publish any responses where it's appropriate to do so. You'll be notified when they're ready for your review. Before we begin, we'd like to submit the following poll. And as usual, I'm sure the company would be most grateful

0:32 for your participation. It gives me great pleasure to hand over to CEO, Jeremy Skellington. Good afternoon. Good afternoon, Mark, and, thank you for that introduction. And welcome everybody to what will be POOLBEG's last company presentation of the year, and what a terrific year it's been. And, again, I greatly appreciate you coming along tonight. I know there's lots of options, you know, to do as you wind up to do it at Christmas and a little bit of football on TV. So the the plan for this evening is to give a a presentation in thirty minutes or so, and then we'll obviously transition over to to questions. And and and hopefully wrap it up in in forty five minutes thereabouts so we can, all get back for the other semifinal. So I want to start, with some reflection looking back at the year, 2022 as it was. And just a flag to you all and highlights, POOLBEG's accomplishments this year. As you know, we IPO ed in July of last year, and we've had a terrific activity along building a pipeline essentially, you know, having some key recruits, key hires.

1:37 And I just wanna spend a few minutes going through this and, again, I'd say highlighting our our accomplishments. So the year review, we started off with, two very important artificial intelligence deals that have progressed exceedingly well in the time since we started collaborations, building off a collaboration initially with based in Israel around the influenza artificial intelligence model, interrogating some very, important it's a very, very unique clinical challenge data. So that's going well. And then secondly, with one three biotech focused on RSV, and as we know, as we've heard, there's a lot of, there's RSV in circulation, these days. So it's a it's a virus of importance, and I think, the dataset that we have is, again, unique. So we're looking for new and novel targets and indeed treatments from that collaboration.

2:23 So, again, as a stated goal at IPO was that we wanted to build a pipeline. Our goal ultimately is for early partnering of these assets. So we in licensed two programs, an immunotherapy for respiratory viral infections broadly beyond, influenza, POLB zero zero two. And thirdly, third program was a vaccine against a bacterial disease called melioidosis. So, again, delighted to get those in, strategizing with our infectious disease, you know, ambitions. And we also received funding recently from the Irish government to pursue oral vaccine platform. And as you see later on, that's topical for tonight as we talk about what was announced this morning, which is an extension to our collaboration or deals with with ANNOBIO around metabolic syndrome. So I'll talk to that later on as well. So, again, we did state at IPO that non dilutive funding would be a core ambition, so great to get our first grant across the line. We've also recently completed our the clinical stage of our human challenge study, our LPS challenge study for our lead asset, POLB zero zero one. Again, a little rush to the end of the year with all of the, the RNSs that have gone out. And, again, importantly, to protect the intellectual property, we've got a number of patents granted this year as well. So very excited about the progress that POOLBEG has made here in the last eleven and a half months as it were. And, again, as I said, we announced this morning a a metabolic disease license for oral delivery of proteins and peptides, and we'll speak to that later on. So, again, 22 in numbers.

3:49 We've attended several conferences. 33 RNs went out to keep the markets updated on our activities. We've given 13, investor presentations, which I have enjoyed the interactions very much. Some in person, you know, some online such as this, but I find it very productive to engage with the the investors. And more recently, we had our first Capital Markets Day, so it was great to have a number of, analysts and investors in the room as we presented, our, you know, accomplishments, but also our ambitions. And then on the right hand side, as I say, we're kinda building as a company. We were had two key recruits this year, David English, who came in to head up our business development activities. And as you know, doing deals will be a core focus for for POOLBEG. We also brought in Sultana Raj Bali as a global prod program director for clinical activities and, again, delighted with the you know, having these two very experienced professionals on board and pushing the programs forward.

4:41 And, more recently and in line with our kind of metabolic disease license this morning, we've appointed professor Brendan Buckley on our scientific advisory board, and Brendan is here by my side. I'll introduce him later on. But Brendan is bringing bringing vast experience for clinical trial, clinical trial execution, and regulatory activities over a number of years. I also again, a popular question on the, the the investor presentations over the months is about, me, buying shares. There was a window of opportunity late in the summer where I was able to purchase some shares as as I say, I was always an insider, so the the brokers agreed that there was a a window there. So I took advantage of that. I mentioned then about the grand funding, 2,300,000 for the the oral vaccine vaccine delivery platform. We appointed Singer as a joint broker and, again, listed on the OTC in The US. Again, we have ambitions to to head to the The US eventually enlist on Nasdaq.

5:33 So quite a busy frantic year. I've got a terrific team behind me, so proud of our activities. I think we'd all be happy with a little bit of rest over Christmas before we start 2023 again in full speed with the JPMorgan conference in San Francisco on the agenda. So what I do now, I just wanna transition back to the the you know, I'm sure a lot of you understand the the business approach, the business model of POOLBEG and the background to the company, but I spent a few minutes going through where we are with that. So we're building a leading infectious disease focused bi biopharma company. We wanna be a one stop shop for pharma and biotech who seek infectious disease assets to add to their pipeline. And I think in a post COVID world, there's a renewed focus on infectious diseases and having assets in there that they can then market. So we spun out of hVIVO, who many of you might know are experts in running clinical trials for viral challenge studies in particular, and we brought a lot of their assets over with us. So we're kind of a viral disease focused, but as you see from the pipeline shortly, building from that. We raised 25,000,000 last year. We have 18,900,000 cash by the June 30. So it's it's a slow burn as a work capital light model, and I'll talk a little bit more about that. So targeting infectious diseases, capital light, early out licensing, and say we do the early derisking of the programs, get that early human clinical data, and then partner with PHARMA. So we're building nicely into, you know, gaining some momentum in that direction. So as I said, we have multiple near term inflection points as well as with later on, but the clinical trial having just this the the early safety aspect just read out and looking forward to seeing

7:03 the full data then into in, q two twenty twenty three. So we have global rights for all our products. Just to be clear, we do in license, but, then we have global rights to do what we want with them. So when it comes to partnering, that gives us flexibilities on deal types, deal structures, territorial deals, for example. So, again, we have a disciplined approach to to move all of our programs forward, and, we'd like to say so far so good. We're we're quite happy with our progress. This is what we see as our four steps to generating shareholder value, identifying high potential opportunities, which essentially are these, late preclinical, early clinical assets that we can, do some clinical studies on and and drive value and derisk the programs. We did mention earlier about nondilutive funding, infectious disease in particular post COVID. There's a lot of, activity in government and nongovernmental, funding bodies to fund programs, such as POOLBEG.

7:54 And, of course, the oral vaccine delivery is a good example. So we push our progress forward to these early value inflection points, out license with PARMA, which is our revenue generating stream, and then we reinvest those funds back into our pipeline in licensing more programs and keep the cycle going. So as I said, we have some exciting assets in the pipeline right now. And as you see at the bottom, I just wanna highlight the appetite that pharma has for doing infectious disease deals in particular. So GSK acquiring a Finavax. They had a pneumococcal vaccine in phase two, but they bought the whole company, for that program and their platform for 2,100,000,000. So PHARMA doesn't mess around when it comes to doing deals. If they like something, they'll, they'll purchase, and, they'll spend money on it. And one good example in our space, in particular, Pfizer acquiring Reviral for up to 525,000,000, and this is for RSV, this respiratory viral disease that we are working on as well.

8:44 And that's one of our AI collaborations focusing on RSV. So there's a lot of interest in this space. So I think we're we're in a good position right now and a good space to to part of these programs in the future. I will say on the right hand side, just so we have a portfolio approach to, like, a multiple shots on goal. And what we wanna do is derisk each program, and those that are successful, then we would move forward with partnering. As I said, we we do look for a clear market opportunities. As I said, the world is looking at infectious diseases, right now, even greater focus. So we plan to have assets in the in those spaces that we can, you know, partner with pharma and, as I said, fund externally as best we can. And I think, importantly, if you saw the you know, from the slides, the first slide that I showed, we have a terrific team behind us, a very experienced team to push, the company forward and get the deals, done that we need to get done.

9:34 So very excited about that. So this is our pipeline as it stands today. I will flag at the outset just at the bottom and say we announced a deal this morning with Anabio expanding on the existing vaccine collaboration we have with them for this oral vaccine delivery. Now we're looking at metabolic diseases, which is an adjacency, but similar to the oral vaccine, it is delivering to the gut and into areas where there's significant unmet need and significant markets. But I'll start at the top, POLB zero zero one severe influenza treatment. As I say, we were happy to announce that, we completed the clinical stage of that LPS challenge study, and the last set of patients were dosed just a few weeks ago. So happy they got through. All thirty six got to the end of the the study and trial. So and no serious adverse events. So very happy with that. And now the full data analysis happens from now, and, again, outlicensed discussions have commenced you know, during our meetings this year with with pharma and biotech.

10:27 Zero zero two and zero zero three, we're pushing forward, building up development plans against seeking nondilutive funding to push those forward as well. So the two product platforms I wanna speak of are the AI programs with RSV program at one three I mentioned earlier on, making terrific progress on this. We started this collaborate eight or so months ago. They've analyzed a wealth of data that we provided, again, unique, exclusive data, and have come up with some very interesting targets to date. And now the next step of that collaboration, which they're nearly completed, is looking for drugs then that we can you can target and bring into our pipeline. And as essentially, you're gonna validate first and then move these forward. And as I say, RSV is an area of terrific importance, but a terrific excitement for pharma as well. And then the second one with Cytoreason, who are based in Israel, they're looking at our influenza targets, and, they're making good progress as well. We have a meeting with Cytoreason on the agenda at JPMorgan, getting an update and, again, expecting to have full outputs by, QT twenty twenty three, which, again, will flag, some novel and interesting and exciting targets from,

11:32 for influenza studies. So, again, so far so good. Everything is progressing well. So I'll start. I'll talk about POLB zero zero one just to give the update there because that's well, aside from the update today on the the metabolic syndrome license for for oral drugs, We announced an update of our LPS challenge study, on Monday. Again, as a reminder, severe influenza is ultimately what we're pursuing, so we have a clinical stage potential blockbuster. Potential peak sales of 270,000,000 for influenza alone in Europe and The US. We do flag the word looking kind of outside that particular indication. We do see there's great potential for p thirty inhibitors elsewhere. So we're, you thinking in that direction. For severe influenza, there's absolutely nothing on the market right now. We're dealing with that cytokine storm that people get when they get severely ill. And, we see three to five million people getting severe influenza every year. So it's still a significant unmet need, and it still needs therapeutics like zero zero one to treat these conditions as they progress into severe influenza for these patients. So, again, the phase one studies are completed. It's safe and well tolerated.

12:38 Everybody enrolled last at the end of trial, which is terrific. Importantly, it's agnostic to viral strain. We're targeting the immune system, not the virus. So regardless of what virus appears, yeah, every flu season, then, this drug has potential for those who progress into severe influenza. And as a small molecule, it's shelf stable, and there's a lot of talk and discussion around pandemic preparedness. So this is ultimately for stockpiling. So, again, a very attractive drug potential. So how does it work? So flu dry flu virus activates the inflammatory response, the immune system activating a kinase pathway called p 38. And what drives that is an over activation of p 38 drives the cytokine storm. And from there, p three you you have tissue damage and lung damage and all the sequelae from from that p 38 over activation. Of course, POLB zero zero one blocks this p 38, and from there, it blocks the the tissue damage and allows the patients to recover quickly. So, again, a very important drug. And as I said, we're we're on our way to to generating that proof of concept data to you know, for partnering purposes.

13:39 Intellectual property is critical in this industry, so we got patents out to twenty thirty eight that are granted, and we're expanding all the time. And, we hope to, to give updates on that in the market, relatively soon and looking beyond, as I say, severe influenza as a disease of interest. A reminder of the flu is still out there. I think we've, we're all they're talking about the triplandemic, this winter about COVID still around, RSV is surging, and influenza is around as well. So one billion influenza cases annually, five to ten million of these are hospitalized, and there's five hundred thousand deaths, which is quite significant. But I think beyond that, there's a six x risk of heart attacks, eight x risk of pneumonia, and it is as risk of stroke. So there's a lot of these, again, sequelae. So if you have, good therapies, you'd be kind of reducing these numbers. So, again, the economic burden is pretty significant in The US.

14:25 They're talking about 11,200,000,000 alone. So it's a significant market, significant unmet need. And, again, talking about them, the challenge study that we've just completed the clinical stage of,

14:37 We ran this in The Netherlands with a group called CHDR. So it's an LPS challenge trial. And what LPS does, this is a bacterial fragment. So it triggers the inflammatory response, the immune response similar to what an influenza virus will do. So you're mimicking that inflammatory response, and you just wanna show the demonstration that p thirty eight will block that pathway. But first things first was to confirm that it's safe. This has already been through a phase one in healthy volunteers, and it was important to re reproduce the data here when it comes to the patients that have been inflamed by the presence of LPS. And importantly, we gave LPS both intravenously to get systemic inflammation and then intradermally under the skin to get that localized inflammation. And, again, happily, there was no serious adverse events for the the 36 volunteers that were enrolled.

15:24 So that was a great milestone, let's say, to be able to pass you know, to get through. And then on the next step is the full data readout. I do wanna comment. I know there were some messages on the board. On the board is that people were we're expecting more data to come from this readout. I think there there might have been kind of statements earlier on about, we were gonna do interim data and maybe a misunderstanding of what interim contained. And I think from our process, you'll see in a slide later on, there's a lot of analysis that is going on right now, and I'll explain later, but that's what's going on in this next phase, which actually demonstrates and proves that kind of, you know, the full efficacy of the program. So on the bottom, we talk about the key highlights here. So no further clinical activity is required. No serious adverse events, safe and well tolerated. Full data readouts in q two twenty twenty three. And you'll see down at the bottom here, the intradermal and intravenous were dosed day four, day six. Three different doses of LPS or sorry, three different doses of POLB zero zero one were given. And this is important as we, you know, progress into partnering discussions of what's the best dose of POLB zero zero one to use in these, influenza studies, severe influenza studies that will follow. So with the comprehensive data package that we'll be, building, you know, we'll have these discussions with PHARMA to keep them updated, as, as these data comes through to us. And, again, importantly, we're at the JPMorgan conference in San Francisco next month to continue

16:45 our discussions with PHARMA around, around these activities. And, again, just highlighting from the comments on the board, this is what's left to do, and I don't want to overwhelm. I won't go into details here. But there's a lot of analysis going on the background from the 36 volunteers that includes safety and tolerability, all the details around hematology, the bloods, the chemistry, urine analysis, coagulation, CRP, on each individual volunteer on each individual day they were enrolled in the trial. So a lot of, work going on in the labs in the background. Also, look at these pharmacokinetic endpoints, you know, the blood and or the molecule and circulation and where it goes and, how it how we excrete it, etcetera. And then pharmacodynamic, which is the the key activities around where the efficacy lies and how your immune system responds to the presence of LPS and then, of course, to the presence of the the POL one in the in the system. This is a blinded study, so we don't know who got drug and who got placebo.

17:39 So which is, again, gives greater confidence in the clinical trial data as it comes out and as it will read out in Q2 of this year. And again, as I say, we're excited to be at this stage from a POOLBEG standpoint. Getting to the end of this clinical stage has been a terrific achievement and accomplishment, and we're delighted where we are, where we stand for that right now. So on other good news, as I say, expanding our pipeline, we had earlier this year established a collaboration with colleagues at Anabio who have this very interesting oral delivery platform. We license for vaccines in particular, which was the the the bed, as you see later on, for the the non dilutive funding. And then today, we looked at metabolic syndrome as the license moving forward with them as well.

18:25 This is just a one slide on the oral vaccine platform. Just to remind you, we raised 2,300,000 in nondilutive funding to push that program forward. And in three years, that will be, clinical ready, essentially. And that's a collaboration with colleagues at anabio using their encapsulation technology, Trinity College Dublin who have adjuvant technology, and University College Dublin who have antigens against, certain diseases. So very excited to have this consortium. And the more we talked with our colleagues at ANNOBIO, the more we saw the potential for their technology, so we expanded our license to include, let's say, metabolic syndrome. And, again, they have, some very exciting early data, which, professor Buckley will speak to shortly about the potential to use, this technology, this platform in metabolic syndrome for diseases like obesity and diabetes.

19:16 So, again, we plan to get early human clinical data next year, again, part of the the business strategy for for POOLBEG, and professor Buckley will will speak to that shortly. But I do want to introduce professor Buckley. As we announced, he he's come on board as a scientific advisory board member. He's actually a a good friend of POOLBEG's. He's helped us from, from the very beginning as part of the the IPO and selling strategy. He's got, forty years or so experience in the in the medical field. He was former chief medical officer at ICON clinical research. Graduated medicine from U University College Cork. He got his doctoral in biochemistry at, faculty medicine at Oxford. Again, lots of experience in metabolic diseases, you know, as a practicing physician. But he's also very, in involved in setting regulatory strategies at EMA and, publishing, you know, multiple papers over many years on metabolic diseases. And, again, couldn't be happier that Brenda's on board to help with these, these trials with with with ANNOBIO around the GLP one space. So I'll hand it over to Brendan. I'm gonna introduce him and look forward to I'll I'll wrap up then at the end when it comes to finishing out the the presentation. Thank you very much.

20:26 Thanks, Jeremy. Okay.

20:35 So when we became more familiar and more conversant with anabios technology, it became clear that there was an opportunity beyond vaccines to protect a payload that we could deliver into the gut by using their encapsulation system. Now the problem about delivering peptides in particular is that the gut is designed specifically to get rid of stuff like peptides to break them down so that we absorb amino acids. So the low pH in the stomach, the protein degrading enzymes in the gut, and the tendency of the gut to exclude peptides are all barriers to getting peptides through orally. So that's why we inject things like insulin and GLP one.

21:35 And the we felt that it would be a pity to neglect the opportunity of exploring the potential of this encapsulation technology. So it doesn't represent a pivot or anything like that for us away from infectious disease. This is just a logical progression in using a platform to see whether we can achieve something in the slightly well, in the significantly different therapeutic area. But actually, it's not fundamentally different. We're protecting vaccines with the encapsulation. We're these are peptides frequently, and we're protecting a different kind of peptide in what we want to do with metabolic disease.

22:26 So basically, what Anabio have done is to develop and commercialize encapsulation technology as a delivery system for fragile bioactives in food and beverages. So hitherto, they have been a food focused company, and they're very successful. And their products are used quite extensively in in foodstuffs. The protection of the payload inside in the capsule basically means that the contents, the payload is protected against heat. It's got a long shelf stability.

23:15 It can be taken in as a solid, as a in the form of a food product or in solution or in a capsule or whatever. It's a 100% protected from the harsh acid environment of the stomach. And by designing the capsule appropriately, we can gear the uptake to the particular part of the gut that we want. And the bio, through a subsidiary which they set up called Insucaps, did a proof of principle with a very small number of pay of volunteers in which they gave insulin, which was enclosed in their capsule material orally to patients, and they showed that the insulin lowered blood glucose.

24:09 They then took another compound called liraglutide, and this is a metabolic disease product used in diabetes and in obesity. And delivering that orally, again, it lowered blood glucose. And these were that's a very simple signal that these fragile peptides are getting into the gut. Now lest anybody thinks that we're going to start developing oral insulins, we're not. Many people have attempted to get insulin into diabetics by means other than injection. And to be honest, it has been a graveyard of capital.

24:59 And the bio have considerable capabilities. They're based in the middle of one of Europe's biggest pharma manufacturing clusters in Ireland, and they have a long ability to make these capsules appropriately. So what we have agreed with them is that we want to extend a bigger clinical trial, which is still a proof of principle. We we're not calling it a phase one or a phase two or anything. This is an exploratory study to see whether we proceed with this approach, given that we have access to encapsulation. So we will commence the we have already commenced the planning and the organization of that trial. It will have to go through regulatory hoops and hurdles.

25:58 It will have to have protocols written and agreed, investigators and sites recruited and so forth. And that will take about a year from now. So we plan that a clinical trial will commence sorry. I beg your pardon. That will take I'm I'm let me go back. I've got myself arsewise, if you pardon the expression. Where do wanna go? Sorry. Now we're here. We're Grant. Yeah. Yeah. The slides are okay. I've I've been jumping into something else in my head. No problem. So the the planning has has already proceeded from that. We've been working on this for about a year, and the clinical trial will proceed early in the new year of 2023 of, you know, in in a month or so time. And this is a feasibility clinical trial to determine whether the microencapsulation technology can safely deliver liraglutide.

26:55 Now liraglutide is a thing called a glucagon like peptide one receptor agonist, GLP one agonist. These have been around, and liraglutide has been around for about fifteen years. In clinical practice, it will shortly be off patent, and it's an injectable. And we want to see by whether by encapsulating it, we can get it into the gut effectively. The nice thing about liraglutide is that it's one of its main sites of action is in the gut anyway. So it makes a great deal of logical sense to deliver it to the gut where a principal site of action is occurring.

27:41 An oral delivery of this stuff can solve a lot of problems. So it's often easier to produce than an injectable. It's much more stable. It's a lot easier to distribute, no cold chain and so forth, long half life. And also, it's a lot easier to administer than an injection. So you don't need training. You don't need special diabetes nurses. Needle phobia doesn't enter into it, there are no sharps or biohazard waste, and there's a much lower cost of access. So we can open up, if we think globally, we can open up access to this very powerful medicine. And the indication for this is in diabetes, particularly type two diabetes, and in obesity.

28:32 GLP-one agonists currently are very fast growing. They're estimated to grow to a 22,000,000,000 per annum market by 2025. And I can tell you that the current manufacturers of injectable GLP-one agonists have had real difficulty in keeping up with demand. The overall market in metabolic diseases, if you include just diabetes and obesity, is truly enormous. So expanding our license to anodebiased encapsulation technology is a really attractive opportunity for us to deliver proteins which are protected peptides and proteins which are protected by the encapsulation.

29:29 And we felt that it would be remiss of us not to take this opportunity of an extra shot on goal given our access to the encapsulation. There are lots of health and cost benefits compared to injection. Potential has been demonstrated in very small clinical trials so far, but, you know, we're about to move it further and test that principle more rigorously. And our next stage feasibility study starting in a month or so, pardon me for misleading earlier on, That will add significant value to the program, and that will make it really attractive for partnering. We're quite confident in this, Jeremy. Thank you, Appreciate Brendan's insights there. As I say, it's exciting time for for POOLBEG as we as we expand. As I say, that's terrific. So what I do wanna say is, again, summarizing in the end, this is a strong investment case, POOLBEG overall. As I said, we've demonstrated, I believe, this year our ability to execute the fact that, you know, we had stated strategies at the beginning of the company at the IPO, and we've, we've hit those goals, along the way. So, again, near term reflection points, I wish there are many, is the full data readout from zero 2001. I did share the slide of all of the data analysis that's going on right now from the 36 volunteers and the three different doses of drug, etcetera.

30:55 So that'll be interesting. And as I say, that'll give that kind of proof of concept data for for partnering studies. Expecting additional information from our RSV artificial intelligence program of one three expected by the end of the year. I know we're kind of mid December, but we're still, working way hard to, to accomplish the the stated goals. The influenza AI program, I said it was, we'd have, the outputs in q two of next year, which would be fascinating. You know, what new targets we could pursue for influenza, which again is a growing issue, continuing issue. Beginning the the consortium work plan for the DTIF funded oral vaccine platform, as I mentioned with our colleagues at Anabio, Trinity, and University College Dublin. As Brendan mentioned, commencing the GLP one feasibility clinical trial early next year. So that's as say, planning is ongoing clinical trial side, principal investigators, etcetera, and, again, expanding zero zero one to new indications.

31:50 Again, remind you, we have an experienced team. We've recruited well not only from the outset, but, your recent additional members, including, David and Sultana, and then, of course, adding Brendan as, SAB member. Again, we have a smart capital efficient model and, pushing this forward, 18 mill mill 9,000,000 by the middle of the year, and, again, supplementing with oral vaccines. And, again, we're in no better place, right now but infectious for diseases. So, again, very exciting time for the company. Greatly appreciate you joining us tonight for this discussion, and I believe in summary that POOLBEG is well positioned to create sustainable shareholder value well into the future. That's great. Again, appreciate your time. Thank you very much. Jeremy, thank you very much indeed for updating investors this evening. 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. Just to give Jeremy a few minutes, I guess, a few seconds to review those questions 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 will be accessible via your Investor Meet company dashboard. Jeremy, I've given you no time at all. You've got a significant number of attendees on today's call and lots of questions.

33:02 If I could ask you to open up the q and a tab. And if I could ask you to read out the questions and then give a response where it's appropriate to do so, and I'll pick up from you at the end. And, obviously, there are a number of questions that are of a similar nature. So I guess what we've done, just try to to make sure that we give you the best coverage that we can. So over to you, sir, if we may. Appreciate that. Appreciate just a little time to to have a sip of water. I will say I did get there was an interesting comment on the boards about I was at a presentation that I I recorded. It was last Friday for the zero zero one announcement. I was actually under the weather. I mean, you know, being in infectious diseases, you know, I had a had a cold at the time, so somebody was commenting that I wasn't my usual effervescent self. So apologies for that. I'll try to I'll try to do better in future, but, I'll say the cold is passing right now, but I appreciate that. But, yeah, let's, kinda read through a few of these, from Harry g.

33:54 Which of POOLBEG's plans for next year are you most excited about? That's like, you know, what which is my favorite child. You know? That's that's a that's a it's a difficult one, but I'm most excited, I think. Yeah. They all have potential. Okay? I'll I'll I'll say that the outset. Obviously, I'll state that, you know, looking forward to the readout from zero zero one and then the partnering activities that will follow. I think, you know, for any biotech company, for us any small biotech company, getting into the clinic, getting out the other side of the clinic, you know, safety, and then getting some efficacy, It's very exciting, and it's a key value driver. So I'm looking forward to getting those data. So, again, that's gonna be kind of a q two of next year. So, obviously, they'll be churning the numbers for all of those data points for those 36 volunteers. So that's exciting. But if I was to pick one other, I think the artificial intelligence analysis will be groundbreaking.

34:43 I think I think back to the stories that were told about how POG zero zero one was identified, how p thirty eight was identified as a key driver of severe influenza was from colleagues at Hvivo who we, spun out of. And they'd spent many, many years looking at the same data, that that we have that we're not using with AI. And from that, it took them several years to identify, you know, several targets narrowed down eventually coming up with p thirty eight. We're doing the same work in nine months when it comes to the RSV analysis and essentially twelve months when it comes to the the influenza analysis, which is quite remarkable. It's just the advancement of AI and what will come out of that, again, will be groundbreaking, I think, for the company, but it's groundbreaking for the the disease sector itself. So we as I mentioned, we're at JPMorgan next month. We've had requests from pharma to talk specifically about the AI data and the AI analysis because a lot of pharma companies are moving in that space. And, again, an obvious example is Pfizer had spent 110,000,000 to extend their collaboration with CytoReason, who who we are collaborating with as well.

35:51 So pharma are looking closely in this direction, and they're always looking for new targets in these diseases. So I say, I think that's something I'm very excited about, the the the outputs from the AI. So sorry. You know, maybe I do have a favorite child, but, know, we we'll as I say, those those two in particular, I'm very excited about, but everything else has potential. Claire, could Cidereason's AI capabilities be applied to metabolic areas announced with today? That's an interesting question, particularly with the, as I said, the clinical data. What site reason look for is clean clinical data, and then they can analyze that. And, obviously, we didn't go into it tonight. Maybe in the next presentation, I'll go deeper into the AI discussions. But they were able to look deeply into those immune responses. With Pfizer, they're looking for for cancer cells and cancer immunotherapies.

36:43 I think for others, I'm not too sure if they're looking in the metabolic space, but it's certainly somebody of interest. I know, Brendan, do you want Yeah. It's it's a very interesting question. I think for us, the immediate interest in the metabolic disease space is simply in employing the the capsule technology that we already have, essentially protecting a payload of a peptide. So I'm not sure that we are that interested in looking for entirely new metabolic disease targets. And I think in we would probably still stick to the benefit that we have in our absolutely unique database and biobank relating to challenge studies on infectious disease.

37:37 So nobody in the world has a database that goes back to just after the second World War that we can mine intelligently now for targets. So I think we're not going to go off and become a metabolic disease company in any sense. Yeah. We're really we're this is an opportunistic, potentially very interesting and very valuable opportunities, nevertheless. Yeah. But I think we will always be at heart an infectious disease company because our huge resource, the heritage we have is in challenge study data going back, you know, right to '23 late forties. Fabulous. Yeah. And just to add to that, and maybe it kinda links it as well that from our demerger from from open orphan as it was or hate fever right now, we do have access to other infectious disease programs, including they have a new malaria model, for example. And they've also run that COVID study for the the the vaccine task force in The UK.

38:41 So we could potentially take other datasets and collaborate with Cytoreason. We've mentioned this, so we haven't kind of actually progressed that, but it's kind of something we potentially could do in the future. So, again, you know, AI, I think, is the way of the future to analyze these unique datasets. Thank you for that. I think question here from Chris g. Jeremy, could you tell me why there was no efficacy data as promised in the RNS on Monday? The efficacy as I mentioned earlier on, the efficacy data is kind of part of this next step analysis. The initial data that we we spoke about was obviously just confirming safety and, you know, that we knew there was a good likelihood. We just wanted to be sure that in this inflammatory setting where, you know, these volunteers had lipopolysaccharide in their systems that the drug was still safe. You know, again, drug delivery drug sorry, drug discovery clinical trials can be quite challenging as it were, pardon the pun, but we were happy to see this. The efficacy will come next. And as I say, we're all excited to see that. And three different doses, so we're hoping that there'll be a good window of opportunity, a good therapeutic window when it comes to identifying the correct dose to take forward from there.

39:50 Let's see here. Where can shareholders access information on the clinical trial of POLB zero zero one? There is nothing on clinicaltrials.gov. That's actually something we we have we have discussions with the FDA about putting up. There's not a requirement. This is a phase one b challenge study. There's not a requirement to put phase one studies, you know, on clinicaltrials.gov, for example. Phase twos and phase threes, yes, absolutely, in phase fours. But phase one is not a requirement, but we are actually in discussions about getting that up. They'll allow it. You know? So we're in discussions about putting that up for the very reason that you asked that people are inquiring. So just to be clear, it's not like we're hiding from it. You know, the trial is is active and ongoing. So we'll we'll get back to you on that with regard to timing. Cool.

40:35 Robin d asks, do you envisage POOLBEG continue to expand outside infectious disease or were these special circumstances here, the existing relationship with ANNABio that are likely to make this initiative a once off? It's a good question. I think, you know, we do say we're infectious disease focused. I do think this was opportunistic, again, collaborating with with ANNABio, their technology, as the expression goes. You know, those what it says on the tin, they have that interesting early human data where you are looking at the the effect of liraglutide on the glucose response. So, again, we want to kinda build that out further. We see this ultimately from a POOLBEG standpoint as partnerable. So you'll get that early, you know, data.

41:20 There are liraglutides out there. All but one are injectables. So, there's a demand. There's a there's an ask. There's an interest in orally delivering this GLP one agonist. So if we can get that clinical trial, as professor Buckley spoke about, and get that early human data, again, part of our remit, we see that something is part of it. So maybe a one up, but, again, we're opportunistic when it comes to exciting opportunities, but we won't lose the ball on the infectious disease folks at the company. Thank you for that. Have you patented POLB zero zero one for stopping cytokine storm in COVID? Really good question. I the where we started out was hypercytokinesia, which is cytokine storm in severe influenza. That's where we had the data. That's where we had the information. And, obviously, when it comes to filing patents, it's based on, you know, novelty and have, you know, data being generated. So we did not have that for COVID. And I think if and if you recall back, this is part of the vaccine, the task force as well and part of a lot of studies that were going on. They essentially threw everything, you know, at the time to help these severe COVID patients.

42:26 There were some interleukins or anti glucagon antibodies worked. A lot things didn't work, but I think we've missed that window. But I think as a company, we've had discussions around, you know, COVID now is being very well addressed. I think, yes, the virus is mutating. There's different strains emerging, and but I think pharma and the the vaccines are pursuing that very well. So I think, yeah, we look up in other areas where we see there's a greater potential for POOLBEG to play a significant role. Okay. Question here, Dave, or when you outlicense POLBONE, are you likely to receive a substantial upfront payment? And if not, when our first revenue is ex ex anticipated? Standards in the industry as we see this type of deal or this type of deal structure will be an upfront with downstream milestones and revenues. And just to explain a little bit more, it's essentially passing across, the program, passing across the assets to our collaborator.

43:22 They will fund it. They will run it. And upon success, we get paid. Now there could be scenarios where we, you know, codevelop it, but our strong preference is for a a pharma partner to take it over and drive it forward. So, yes, the standard in the industry is upfront payments, milestones, royalties, kind of into the future. And, from a POOLBEG standpoint, we have multiple shots on goal. You're right about POLB zero zero one. That's our first one. And, you know but, obviously, we're looking for the other programs moving forward and, indeed, even the AI data that comes out of here. So I think that, you know, there's great potential for for that and our other programs. Question here from Sparky j. Great name. Are we already in discussions to reverse into any Nasdaq listed companies, Should it be viewed as a way of raising capital with a cash rich company, which POOLBEG bringing good products to the table? We know that we had 18,900,000 six months ago. What's it looking like at the year end of 2022?

44:16 So there's a few questions in there. But, yes, COLBEG, I think, mentioned at a recent presentation, we continue to look out for, some, NASDAQ companies that could do the cash injection, maybe a pipeline of their own. And, we have spoke to several, and, we'll continue to do so. We're looking for that right opportunity. So we do again, as I say, there's there's good ambition that POOLBEG will eventually end up on The US market. And it's good for fundraising. It's good, I think, for, you know, getting into a larger market, as I say, from a from a, you know, a share, you know, price standpoint. You have more greater liquidity, for example. And, again, maybe the sum of the two companies will will drive a larger response. So, yeah, we're it's still on the horizon. As I say, they're, you know, discussions we're we're scouting.

45:03 There's a there's a lot of companies out there that call calls fallen angels that we're we're exploring to see what's a good fit for POOLBEG. And then the bottom question was or the the question around the the cash balance at the end of the year. Obviously, we haven't run the full numbers. There's still a couple of weeks left at the end of the year. We'll, yeah, we'll talk about that next year. I think it's in March. We have our our order updates, our annual updates on the finances. So we'll we'll address that. Just keep a close eye on time. Let's take one more question because I'm sure you're eager to get back to the football. Henrik, what size do we have on the oral obesity delivery market, and what news on The US listing? Sorry. I've I've just answered that. On the oral obesity delivery market, I mean, obesity is is is frighteningly large. I think it's a growing issue. It's a significant issue. I think there's two yes. I was looking at this. Thank you.

45:52 Because the obesity has nearly tripled since 1975. US health care system, it cost them 173,000,000,000, and global obesity sales in 2030, so not too long of 54,000,000,000. So, again, with this kind of program, you know and there has been progress in the obesity space of late, but if we can kind of edge ourselves in there through a partner, obviously, and get a share of that market, it can be quite significant. And I think, obviously, you know, from a POOLBEG standpoint, from a CEO standpoint, it would be wonderful to to have a significant role to play in in treating this disease. As I say, would again pardoned upon, which which is kinda growing and is causing, you know, significant issues for other health aspects. I mean, we all know that obesity creates issues, you know, drives cancer, you know, cardiovascular disease, etcetera. So, yes, I mean, it's it's a it's a large market and growing, so we hope to play a role. Okay.

46:42 So on that note, again, on behalf of professor Buckley and myself, thank you for taking the time this evening. I hope you all have a good end of the year. Have a great Christmas, and we'll see you all again early in the New Year and keep you continually updated on POOLBEG's activities. Thank you. That's great. Thank you very much indeed for updating investors this afternoon. Could I please ask the investors on the call not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order the management team can really better understand your views and expectations. It's gonna 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 POLBEG PHARMA, we'd like to thank you for attending today's presentation. Good evening to you all.