Poolbeg Pharma (LSE:POLB) — Company Update

0:01 Good afternoon, and welcome to the POOLBEG PHARMA PLC company update. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time by the Q and A tab situated in the right corner of your screen. Just simply type in your questions and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company will review all the questions submitted today and publish responses where it is appropriate to do so. Before we begin, I'd like to submit the following poll. And I'd now like to hand you to Carlisle, chairman. Good afternoon, sir.

0:31 Good afternoon, man Mark. Thank you very much for hosting our presentation, and many thanks to every registered and every online. It's a looks like a record number. As you know, I don't hear that often. I live with Jeremy. He's been doing a fantastic job, and the old chairman, myself, and cofounder only appears when there's something exceptional. So today is one of those days. I'm really excited to be able to present some of these exciting new developments in POOLBEG. Just before we come to to set the scene, as probably somebody know, we're talking about a pivot towards AMRED. I think it's appropriate. Let me spend two minutes telling you about the couple of previous life science companies I've put together and why I feel now POOLBEG is about to copy them. For those of who don't know me, my name is Kyle Freel. I'm the cofounder, chairman, and largest shareholder in both POOLBEG PHARMA PLC and also HFOBEL PLC, both of them listed in London and for I know we've some new investors on board today who haven't bought shares.

1:30 Litry, POOLBEG, and HPFO. You can buy them by ringing any bank manager, any stockbroker. Since 2012, basically, these last eleven years, I've successfully IPO ed four companies which I cofounded, was chairman or had been chairman and always tried the largest shareholder. The first life science company that I IPO ed was AMRED PHARMA, which I cofounded along with Joe Wiley in 2015. We IPO ed the following year in 2016 on the back of an acquisition of a distressed German life science company called Birken AG. Birken had 56,000,000 invested in Zabai in Germany, and we managed to acquire it for the princely sum of €1,000,000. The reason we got it so cheap was a bit loss making and distress.

2:15 We IPO'd Amrit at a market cap of 29,000,000. In 2016, raising 10,000,000 new funds to give the market cap of £39,000,000. This is actually really close to the similar market cap that we've done with POLBEG, which we IPO ed just two years ago. Amrit went on to acquire a number of several distressed life science companies, and the great news is, and some of you already know this with your investors now, Amrit, it got bought for 1,480,000,000 by k z earlier this year. The second company IPO was open orphan in 2019. And after acquiring another distressed life science called Van Life Science, which we acquired for 5,000,000, six months later, we bolted on hVIVO for 7,000,000, where, again, like Birkin, hVIVO had a huge sum of money invested in it over a 150,000,000.

3:05 So buying at a knockdown price of 7 was pretty good. Then then LifeSense or hVIVO ever made money in their previous twenty years, But within two years of merging them within open orphan, which we have now named h renamed HP, it is hugely profitable, making excess of 10,000,000 a year with substantial sales last year in excess of 50,000,000 and a growing large cash balance of over 30,000,000 cash in the bank. I'm giving this context because people say that this is open often. People knew it was one trick wonder. Amrit's one trick wonder. Well, you could say I got lucky twice. So Today, hopefully, get lucky a third time, but I think as Margaret Thatcher once said, you don't get lucky. It's just the harder you work, the luckier you get. So the reason we invite you all here today is that I now see huge similarities in what we successfully did in Amrit and what I think we could do with POOLBEG.

3:59 Now POOLBEG, I, first of all, repeat, and I am a very hands on, as Jeremy knows and knows, that any company got involved. I try to be the largest shareholder and quite hands on. I like the chairman role. It's nonexec, so the new gentleman coming in, the lady today, and Jeremy gets on with running the company. My role is make sure it's going in the right direction. And I would make it clear as a largest shareholder, I will plan and certainly would look to try and increase my shareholding at appropriate time. There's always issues of trying to find a period where we're not in receipt of inside information, but certainly POOLBEG is something I would like to increase my position in. You've been seen you may have seen our r and s from yesterday morning from POOLBEG, but if you haven't, let me fit you in. Basically, POOLBEG is about to pivot and replicate the fantastic success that we had with AMRED, and yesterday's RNS is just the beginning of that process, where we've announced we've hired three key AMRED pharma executives who are now in the process of joining Jeremy Skellington and the team here in POOLBEG.

5:08 As such, I'm very confident in the weeks and months ahead, we can replicate that success we've had with AMRED and yet again, create another billion dollar market cap company. I'm really excited as to what POOLBEG can now go forward. Let me introduce the new enhanced team in POOLBEG. You'll see from the slide, this fantastic leadership team, and they've got very, very important. It's dual skills. They have skills in drug development. This is developing the big blockbuster drugs that we have with zero zero one, hopefully going into oncology. But really importantly, there's no good development blockbuster in burning cash. I like seeing sales, revenues, and profits. So the team have now, particularly Dave and the colleagues coming in, have actually skills in selling drugs, building markets, generating profits. So that's just for him.

5:59 I won't dwell on myself. I've said enough. Jeremy will is well known to you all. I need to do his introduction. But briefly, which is important, our CFO, Ian O'Connell, is actually my business partner, and he's one of our POOLBEG cofounders.

6:13 And he's been on the board of POOLBEG since his IPO. Ian and I also cofounded Hvivo PLC, formerly known as Open Orphan. And in actual fact, when Ian joined me in Raglan Capital in 2015, one of his first jobs was to head over to the Irish company registration office and register the new company, AMRED PHARMA, and that was 2015. Dave Ammond here is now the first of the big guns joining us from AMRED PHARMA. And as our chief business officer, I'll now ask Dave to step forward, introduce himself, and tell us two or three minutes, what he did in AMRED to help build it into a billion dollar company. But most importantly, tell us how he's gonna help us now get POOLBEG to be a billion dollar company.

6:58 Dave, can we give two, three, four minutes on your background, brief you through the all of our participants? Yeah. Thanks, Kyle, and for the introduction and for inviting me for a a cameo role today. I'll be joining the the organization in December, very, very honored to to join today. When when RNSs go out like that, you always think, my goodness. What's gonna happen to the stock price? And, thankfully, it popped up a bit. So that that was good for me to see that there's some encouraging feeling around this pivot. I'm gonna talk to you very briefly about three things. One is, my history, which is I'll keep brief, purely from a credibility standpoint. Touching also on on Amrit on it and briefly on its journey, which I played a a major role in among others, and then really may may you know, how we apply that going forward, to to POOLBEG PHARMA. So my my background is nearly 30 in pharmaceuticals, mostly operationally in increasingly strategic or leadership roles.

8:02 I think most notably from, you know, exciting learnings I had in my career, I spent nine years with Amgen in the ascendancy in six different jobs across Europe, Middle East, Africa, including UK and Ireland. Fantastic learning ground, fantastic growth company, even to this day going going strong as as we all know. And And and at that time, you know, nine years into that role those roles, I had six roles, I I was approached by what was a small company at the time called Celgene Corporation. And Celgene had some presence in The US, but I was a number five employee in Europe. I took on and built The UK operating company for Celgene from scratch, put the main product once it was approved through NICE. And when we acquired additional products from PHARMAON, etcetera, that company grew to a 300,000,000 affiliate in in in within the realms of the Celgene world.

9:01 And that was fantastic learning as a general manager.

9:05 The US leadership were were happy with that performance because UK is notorious for reimbursement challenges, and we we were successful in that regard. And they asked me the European leadership asked me to build the marketing and market access team for for the region, for Europe, Middle East, Africa, and Switzerland, which I did and made that a very strong, effective team. And then I was grateful, very grateful to be invited to build and lead global marketing for Celgene for for probably one primary reason, really. Celgene was a more of an r and d led company, and I think it was time to balance that up and have commercial leadership co chairing its development committees and putting robust plans together, for investment, both organic and inorganic, and I spent three years doing that. And and when I came back actually to The UK, I was taking a little bit of time out. Agerion, which some of you will be familiar with, another American company had not had a good time entering Europe, actually was consulting trying to fix that European entry. And I I think I was actually.

10:09 But, unfortunately, at that time, the company decided to pull out of Europe for macroeconomic reasons. They were going into a deal with a Canadian domicile company, and wanted to preserve cash. So I I actually got a phone call saying we're gonna pull Lumetopide or Lejuxta. We're gonna pull out of Europe. Not only that, we're gonna pull the drug. And I was horrified by this news because it's actually a great drug for a very serious disease. And that's why in the end after, I was given an ultimatum to to to sell it within three three or four months, which I did. I sold it to Joe Joe Wiley and Rory Neland and Mark Sumire at Amrit on a royalty deal, so there was no upfront. The drug has already announced it was dead. And later, a few months later, I joined the Amrit team as a sort of fourth or fifth or whatever employee. So very early on, spend the next five years hands on building global commercial operations, market access capability, partnering with medical affairs to really drive growth of Logixa across Europe, Middle East, Africa. And then bondholders in New York saw that success and decided, actually, these guys know what they're doing, did the deal with with them and did the, you know, the after the chapter 11 for was put they were put through. We we could take out the mother company and get global rights to two fantastic assets.

11:32 Very proud day for me because those assets were fantastic, but the company was loss making to Kyle's point, and it was burning cash. And so we could really be stewards of those great assets and and capital and grow worldwide. The company therefore reached up in the direction of 250,000,000 of income from scratch pretty much in those in that five or six year period. And that was a super exciting time, which is why ultimately after then an an acquisition of Chiasma, which I was central in in amongst the team in brokering that deal and executing against that deal. The company then, you know, eventually became very interesting for strategics, which you know well. Chiesi, in in the the end, being the buyer for the company.

12:18 So I couldn't ask for more from a career and learning. It's about patience, high unmet need. It's been about building company, building growth, building contribution for patients, for the team, but for also for the shareholders. So I think for POLBEG, I think, really, the opportunity here is to you know, we've got some great r and d programs already in play. The company have built that as I come into the company in December. But really now it's find a beachhead, get going, get get get momentum, build build revenues, build contribution to reinvest. And once we get that team talent and and that that capability growing

13:02 in certain geographies, we'll be able drop additional assets in to leverage that capability and and build, you know, build the kind of value that that we've that we've experienced hands on, in the past. And it will be my pleasure to, to to deliver on that as part of a team, and we look forward to keep you abreast of of of changes as as as we get, as we get breaking news in the coming weeks and months. Dave, many thanks for that. The other new top gun coming McCollum coming from Amrit is John McEvoy, who's unable to join us today due to prior commitments as John is still I'm his full time chief legal officer, so I'm not so sure Casey will be too happy with John sitting and fronting everything up. But John is signed, committed, coming on board, as soon as his commitment to Casey on the January 1.

13:54 John was helping Amrit acquire low cost assets along with Dave. And most importantly, and this is kind of our direction of travel, he also led the charge in ensuring Amrit got successfully dual listed NASDAQ. So you all know we're pushing this NASDAQ idea for quite some time, so John will be hugely valuable to POLBEG going forward. Thirdly, we also announced yesterday morning that Laura Marr has also joined us from AMREC and come in as VP of clinical operations. I know from some of the questions online that have come in today and overnight that you may be wondering, is our cost base going to increase substantially as a result of the view these new hires? However, we are always conscious of making money, and making money means not losing money and getting EBITDA profitable.

14:43 We like money to go a long way. As such, David Almond is replacing our existing POOLBEG senior business development executive. David English is likely leaving. We're on very good terms, but he realizes that we really have to step up to the big boys league now with real sales and real revenues by having the likes of Dave Hammond on board. And furthermore, Laura Marr is replacing our existing clinical operations executive. And, again, Sultana is leaving in very good terms. We just don't like we're still a small biotech. We can't build a monster. And as a fact of life, we've got to sometimes churn some of our staff and keeps other people hungry and more excited. So as a result of these fantastic three new hires from Amrit, our cost base will only increase by one, namely John McEvoy, our new global general counsel.

15:33 So in summary, I hope you'll see we have a fantastic and really experienced new people coming aboard to support Jeremy. And one brief last slide I just want to show you, and this one to try and stitch things together, is what we did in Amrit. This dual track approach, you can hear an awful lot more over the weeks and months from Jeremy, from Dave, from John, what that means. So I would draw your attention if you look at the bottom left hand corner of this slide in Amrit. And, basically, Joe and I IPO ed Amrit in 2016, and being frank and honest, it was around the 50,000,000 market cap. Being frank, it went nowhere. And, actually, in fact, it went down a bit by 30% price wise. But those are viable years, getting the team together, getting trading, getting institutions in.

16:22 The small companies don't happen overnight. And then the end year two, as we went into year three, Dave came on board with the rights to the and the opportune word, he said, no up fund payment. And this idea, we're good at picking up the stressed asset. It was a distressed deal. And within twelve months of Dave joining, you can see that number two block there with 17. Amber went from virtually no revenues to 17,000,000. And very quickly, revenues start going. And you see the light blue line, that's not the sharp eyes. It's the market cap. So after acquiring the rights to the at no cost, we get 17,000,000 in revenues. 2019, another distressed deal. Again, Dave brought this. This is an old company, and he worked with Joe, Rory, but most importantly, John McEvoy to take a journey in and out through chapter 11 in America.

17:16 Point four, revenues then very quickly can go from no revenues in 2017, and within four years, revenues were 265,000,000. And the rest is history. Big pharma comes banging in the door. So, basically, I think what we're saying is dual track. This is having these blockbuster products. Amrit had them as well, but there's no good on blockbuster products and burning true cash. You have to have the revenue. And all we're saying clearly today, we are gaining close to having real revenues, a pathway to profits, and that's critically important. I showed you the other slides about what we did in Open Orphan. The two previous companies, Venn and Hviva, never made money in the previous twenty years. We put them together within two years, highly profitable.

18:03 Likewise, was make money for the cup two years within year three, EBITDA profitable. We're guiding now. That's the plan for Jeremy, Dave, John, and the whole team to really drive. And just in summary, I'm so excited. I won't be popping up too often. The job of the chairman is stay back and get out of people's way. But I say I'm the largest shareholder, and I've never been happier to be holding POLBEG share. So, Jeremy, maybe I'll hand over to you. Yeah. Thank you very much. Super. Afternoon, everyone, and thank you to and to Dave for giving us their their perspectives. Again, as alluded to, very exciting time at POOLBEG, very exciting, you know, this kind of transition, this pivot that we're doing. And, you know, as I say, there's a lot of, excitement as we move this forward.

18:52 Again, as we see here at POOLBEG, we believe we're now, you know, very well positioned for success. And a few bullet points just to flag or to highlight, you know, in that, you know, enhancing the leadership team, obviously, brings lots of knowledge and experience. And as Carlos said, the dual business tracking of both research development and commercialization. I think that's a very exciting time for the company. And as we drive that forward, as I said, terrific new hires that'll, I think, fit in seamlessly with the, you know, the culture we have here at POOLBEG, but very much focused on, you know, driving our, you know, company forward. The dual track, I think, is very important. Again, Kaho went through the AMRED story, and we feel that, there's great scope to to replicate that. I'm at two point o if you if you like. Again, having the experienced teammates, you know, on board. But also, you know, as I say, you know, looking for for assets to bring in, but continuing development as well of our own, programs, which in their own right are very exciting, and I'll talk to those quite shortly. So, again, focusing on market products and, again, cost effective development. You know, Kyle is right where we're very much focused on managing the spend and keeping the cost low, and I think we've done a terrific job with that thus far.

19:58 We see of our own pipeline. I'll touch upon this high value program zero zero one. I'll touch upon this is our second investor meet presentation of the week where we talked about our oncology angle earlier this week, and I think that was very well received. And I'll touch upon that shortly for those unable to attend. The AI led, again, that's something that's, you know, quite exciting and unique to POOLBEG having access to datasets. And now we have some terrific outputs from those AI artificial intelligence collaborations. And then lastly, looking at, metabolic diseases and oral delivery of certain drugs. So, again, we're in a very good position to push these forward, strong financial position with a cash balance of 14,100,000. And as you see here, very modest g and a spend in the first half of this year, 1.4. So, again, managing the spend. So long runway ahead, but as you say, we're in here this pivot. As I we've got a good deal of kind of buffer comfort to to get us there. So, again and on top of that, just, you know, balancing that with accessing nondilutive grant funding. So, you know, terrific time for for the company. Again, won't dwell too long in the pipeline. I think you've seen this before. Will I talk about zero zero one shortly, particularly in the oncology aspect, the partnerships I mentioned. We'll talk a little bit about the the the metabolic diseases aspects later on as well, but we get a nice robust pipeline that's moving along well and, you know, generating key data that, again, will be attractive to partners. Because as you know, that's one of the ultimate the objective business plan of POOLBEG is partnering in that sense. So I'll touch upon those.

21:28 Focusing in on POD zero zero one, blockbuster immunomodulator for severe influenza and oncology. Again, we're we're gaining some nice momentum with zero zero one right now in that, you know, it's an oral small molecule, excellent excellent bioavailability. It's proven and well tolerated. It's a clinical stage asset, so we know how it behaves in a human setting and indeed in a human setting where there's an inflammation condition. We got excellent data coming out of our LPS challenge study early this year, which then, I suppose, you know, allows us to go in different directions with with the molecule in this acute inflammatory conditions, but also, you know, supports partnering efforts because, again, having human data is something that pharma companies really like to see when they're when they're bringing in programs in house. Importantly, in this industry, we've got a a strong patent portfolio granted patents in severe influenza out to 2038.

22:18 So a nice runway there. And earlier this year, filing patents in the oncology space. And, again, I'll touch upon that and how exciting and excited we are to move into that space. I'm, I'm a a dyed in the world scientist by training, so I was trying to slip in one data slide. And and I think this just demonstrates how effective the, POLB zero zero one is in this, recent, LPS challenge study. So, essentially, what we're looking looking at here is, the cytokine TNF alpha, which, again, as you see, is is upregulated in the gray bar when you're challenged with LPS. Though LPS is a bacterial fragment tricking the immune system into thinking that there's an infection, mobilizes all of the immune cells and starts expressing cytokines, and, you know, you're heading down that direction. So if you look at the gray bar, as I say, that's the highest. That's with no drug. Lowest dose of drug in the green bar, there's some reduction in that. And quite impressively, in the medium dose and the high dose in the the blue and the red, we're we're essentially kinda shutting down the vast majority of these cytokines and TNF.

23:18 And, again, so that confirms the targets, you know, is being inhibited. We take drug orally, gets into systemic circulation. It gets into cells. It finds the target and blocks the target. So it works really, really well. But I only give TNF as a alpha as an example here, but we're also seeing statistically significant reduction in the expression of interleukin six and interleukin eight other cytokines. Again, this is all part of the, you know, the cytokine storm. So we're kind of quite excited to see that our drug can have this dramatic effect. So, again, dose response relationship. And, of course, it's safe and well tolerated, and you got to see this in this situation. So we see, again, this mirroring of the activity of the LPS challenge across to what happens in a severe influenza setting and, of course, in cytokine release syndrome in the CRS setting following immuno oncology treatments. I think that's really generated a lot of excitement both internally and externally to to POOLBEG very recently.

24:10 I will just describe the cytokine release syndrome and and what it is. You know, there are several triggers. It could be an infection or it could be this immunotherapies. And it's essentially it's activating the immune system, but it gets itself out of control. So it's essentially the cytokine storm that's kind of increased levels of cytokines are being expressed. And what happens then is a sequelae to that. We get these clinical manifestations as we described on the right hand side. So you get a fever. You get increased heart rate. You're hypoxia, so you're struggling to get oxygen in your system, and again, low blood pressure hypertension. And, you know, they describe these as kind of flu like symptoms, but then there's a rapid progression for a subset of patients where it causes acute kidney injury, neurotoxicity, leakage of capillaries, your vasculature, you know, having having issues kind of, you know, containing the blood. So, again, it goes downhill from there, there's coagulopathies and and ultimately, in some patients, death. So it's a very severe significant issue for those patients that get that severe end of the spectrum of cytokine release syndrome.

25:07 And, again, it's a significant issue for for patients, obviously, and for pharma companies. And as I say, on Monday, we talked about the oncology aspect, and we have a terrific presentation. Martin Kaiser, you know, at this time, presents a lot of data on the impact of immuno oncology drugs on his particular area of interest, myeloma, but also that there is this significant issue. And I've I've, you know, you know, shared with you here one of the slides that Martin presented. So what we're seeing is this is a a bispecific antibody, and, you know, you do see really strong efficacy with these drugs. So the graph here on the left hand side, this is, what you're seeing here is a an overall response rate. So these are the patients responding to the drug of upwards of sixty three percent, which is fantastic. You know, if you're you're diagnosed with myeloma and you're looking for treatment options, you know, this is certainly a really, you know, good option because you see a lot of, you know, strong efficacy responses, you know, from these patients.

26:08 But the challenge on the right hand side

26:10 are the cytokine release syndrome. So upwards of seventy two percent of the patients that got this drug in this particular trial, Majestic one, developed cytokine release syndrome, something that was CRS. And what that does then the challenge with that is that, obviously, number one, the patients, you know, feel bad. But number two, it extends their stay in the hospital, and that's kind of an issue and a challenge and puts pressure on the health care system. So there's always that goal of kinda, listen. If we can reduce CRS, if we can block CRS somehow, you know, the patients get home quicker. There's more hospital beds to, you know, to to

26:41 to fill with the new patients coming through. So there's kind of a you know, you're trying to kinda get that conveyor belt of patients through the system. So what we're seeing here, as I say, is terrific efficacy, but really challenging when it comes to managing CRS. And I think, you know, very excited that we can, you know, potentially play a role here. And I think on the back of that, as I said, this is where we kind of you know, we we talk about pivots. We go in the direction of looking at oncology and the zero zero one data we generated with the l p LPS channel study. We applied, to present, kind of an abstract and a poster at the upcoming, American Society Hematology meeting in San Diego in December, and this is where 25,000 or so hematologists, you know, scientists, clinicians, even patients to send for this conference to learn what's going on in the space, on in the area. So we applied, to to present some data, and we're very happy to see that it was accepted. You know, they see potential. You know, these, experts or leaders in the field that zero zero one could play in, in, you know, as I say, decreasing, you these cytokine release syndrome that are issues in the hematology spaces. And we do talk about the bispecific antibodies as well as the CAR T cell treatments as well. So, we have, our our colleague, MSOBEG, colleagues as well, Liam Tramble, who's driving the scientific aspects of the program, and professor Brendan Buckley, who've, many of you have met before, driving that forward as well along with our our colleagues and, at CHDR in The Netherlands.

28:08 But, again, very excited to present this data, share it with key opinion leaders, you know, share with pharma companies who are obviously, you know, keen on interest to address this, the CRS, you know, cytokine release syndrome issue that they have. So, again, you know, exciting for POOLBEG, exciting for the company to be branching into that direction, you know, in addition to severe influenza. So we see, again, with the same drug, multiple potentials. So we see a lot of these, big pharma companies. You recognize these logos undoubtedly. They've got a lot of programs in the immuno oncology space. It really is transformative what immuno oncology is doing right now using the patient's own immune system to go after the the other tumors, in the system. So, again, there's strong interest for pharma that if they can manage the CRS, they do see there'll be an increase in market size, market shares for for their drugs.

28:56 So a lot of interest in seeing how POLBEG can can address the CRS complications from these cancer immunotherapies. So, again, we have we we've mentioned this before. We have discussions going on ongoing with prospective partners. And, it's about, you know, getting a good deal. We're all about the transactions now with POOLBEG, you know, on top, as I say, of the the commercialization aspect that that David spoke to. So good discussions going on in that regard.

29:19 So, again, like I've said this before, we're gonna watch the space. And so we've got a few weeks to ASH and, you know, several meetings set up to discuss this and, obviously, planning forward for our clinical trial CRS clinical trial next year. So switching on to our AI programs again, I'll keep it brief because we wanna leave time for for questions at the end. Certainly, I'm sure there'll be, you know, questions for, you know, for for Dave and and myself.

29:45 So the AI programs, again, through our collaboration with hVIVO, when we demerged, we had access to very exciting datasets of the challenge models that they run, particularly in influenza and RSV. So we took this huge, you know, very large dataset. And, you know, it would have been too difficult, too large, too, too lengthy, too expensive to do some, lab analysis to understand what's going on from a disease progression standpoint. So we collaborated with two companies, to look at

30:15 this influenza dataset. This is with Cytereason based in Israel, who have a number of existing pharma collaborations, including Pfizer, Ross Roche, Sanofi, and Merck. And, again, to identify novel drug targets in the influenza space. That's a terrific collaboration and, again, took very short fourteen, fifteen months, of time and effort to understand the disease progression and coming up with novel targets. And I say novel targets. These are, you know, genes that are increased expression, but heretofore were not identified to be involved in influenza or indeed infectious disease progression. So, again, great novelty there for that, so we're moving forward now for lab based validation. And then we took a different approach with one three biotech where we got them to identify the RSV dataset, but wanted them to come up with, initially kind of RSV drug targets, but drugs that pair with those targets.

31:06 So these are existing drugs that then we can go quite quickly into validation and ultimately into the clinic through partnerships to look at this RSV space. And, again, this is a, you know, significant issue with the elderly and the young every winter. You know, many different infections coming through in the RSV space. So, again, excited about the progression from that. And then the last section I'll speak to will be is our oral delivery platforms. Again, part of our pipeline usually utilizing validated delivery technology to develop this technology to our collaborators at on the market in the the food science area. So we're, you know, reapplying it to the the pharmaceutical sector. And, so we're, you know, focused in right now on metabolic conditions. So we have a license for their technology views in metabolic diseases.

31:53 And, you're quite excited with the first program that we're moving forward here, so oral GLP one agonists. So, again, these are very exciting drug class, majority of which are injected. So they're looking for alternatives to, you know, avoid injection. And, so we are planning a proof of technology clinical trial, incorporating, this oral liraglutide, you know, delivered orally and running a clinical trial next year. So we're, you preparing all of the, you know, documentations. The clinical trial site has been identified. The principal investigators identified. So moving that forward. And, again, we see if we can deliver this drug orally, that will create significant excitement in the field and in the space, and, again, ultimately making, you know, our partnering efforts easier, you know, having that data. So as I say, that's the plan is, you know, to have that trial, you know, commencing in the first half of next year and likely read out in a very short period of time. And one of the the POOLBEG strategies, these are very short clinical trials. We do not go into very long clinical trials similar to the CRS study.

32:55 It's just looking at, you know, the effect of these drugs in a short setting, but gives you valuable human data ready for partnering. And one of them, I will say that the GLP one agonist market is huge and growing dramatically. There's been some really exciting data of late demonstrating its efficacy in not just diabetes, which has been known for a while, but in obesity, reducing weight for obese patients. So and then cardiovascular benefits as well on top of that. So very exciting drug trials. And then more recently, we partnered with a NASDAQ listed biopharma company to produce a prototype oral drug for their for a metabolic condition, something that they're working on, but they're looking for a kind of a new and improved version, let's say. So the potential for now following our proof of concept collaboration is to expand into a full licensing agreement.

33:43 I think importantly, with this platform, with this oral delivery platform for metabolic conditions, we can do numerous of these type of deals into, yeah, whatever car cargo, yeah, we want to to put in and insert. So very exciting from that standpoint. So, again, my last slide before we'll open the floor for questions is, again, the investment case. As Dave mentioned earlier on, very happy see that, you know, our oncology story represented on Monday, the r and s that went out yesterday about the new colleagues. Colin mentioned about the pivot has been very well received. I think people see, you know, the the job we've done thus far to move the programs forward, again, in our kind of managing the the the, you know, the the the capital burn accordingly. But I think now we're we're in this kind of, like, nice kind of inflection point where the company will grow. And, again, the associate share price similar to Amrit is our is our drive and our our ambition to achieve. So enhancing the leadership is obviously very exciting time for the company. Lots of knowledge and experience coming through. The dual track business model, I know Kaho has mentioned plenty times in the past, you know, the past about your traditional biotechs who basically is like spend, spend, spend, you know, until, you know, they're they're kind of, you know, running out, you know, but we never intended to do that. So, obviously, you know, supplement or complementing that business strategy now with commercialization will be very exciting for ourselves as a company or for patients and, obviously, ultimately shareholders.

35:08 And, again, it's it's it's seeking and attracting these high value programs. You know, lots of diligence going on. So, as you say, it's a case of watch this space. There are a lot of, activity going on to to bring in these, you know, commercialization, stage programs into into POOLBEG. And then lastly, as a reminder, a strong financial position we find ourselves in, 14,100,000

35:28 in the middle of this year. Again, very low, you know, cash burn overhead, which we will carefully control. Again, that's something we do quite diligently. And as I say, I think this dual track business model is is ideal for POOLBEG with the stage of our development, the stage of our growth, the stage of our progress. So looking forward to the the months and years ahead, as I say, with the new colleagues and and ultimately with new programs and moving forward our own existing pipeline. So, again, very excited about where we are sitting right now. And, again, as I say, we'll we'll keep the markets updated as we progress and have more of our news flow, let's say, over over the the coming months and years. Again, greatly appreciate your time for that, and we will take some time now for for some questions.

36:14 I think there's a few pre submitted. And if I can, I'll read out the questions and then maybe point the finger at either COHOL or Dave or myself who's best placed to answer that. So we'll we'll we keep it going in that standpoint.

36:29 First question was pre submitted. Licensing new drugs takes time. Are you expected to need additional cash before sales income at POOLBEG is established and maybe a rights issue? I guess, you know, I could start off on that. And, Dave, you, you know, you gave your amored example. But I think there are, you know, drugs out there. There are, you know, assets available. These are, you know, tough times for many companies to say we're fortunate to be in a good healthy cash position. But I think, yeah, they do take time with with John McAfee on board. He's a very experienced lawyer. He does deals really quickly. And as I said, minimizing any, you know, upfront, you know, payments, I think that will be, you know, a key focus of POOLBEG. Dave, do you wanna add anything to that? I know you touched upon your your Amored experience, which I think we will try to mimic. But, you know, there are opportunities out there, I feel, you know, that that would be ideal for POOLBEG. No. I think I think that's right, Jeremy. You know, my as I keep my ear to the ground and my eyes open, I'm seeing a lot of distressed assets, see, including approved assets where cash has been tight.

37:38 They've been burning cash or or or their their peri approval. They're in phase three or, you know, and and and they've not been adequately launched. So Yeah. Unfortunately, as a result of pandemic and people burning through the cash and not quite getting over the line into organic growth. I'm seeing more than usual. And when I come on board in December, we'll put the, you know, the the foot on the gas and and, you know, deals are there to be done. And I think we can move very quickly on on a deal to get a beachhead. That would be the the goal. Because once you you know, you can be spectators in life, and you can talk about strategy, which which I like talking about, by the way, but you need to, at some point, to get on and get into gear and then build from there. And I think that's what we'll we we will do fairly quickly. Excellent. Alright, Dave. Thanks for that. Another pre submitted question. I think Huddl has probably addressed this already, but are these full time employees and how do they fit with existing structure? Yeah. I think Huddl addressed by replacing existing staff.

38:43 And as I say, just removing, as I said, the the overheads don't increase that much, but I think the the productivity will be will be terrific again given the you know, as Dave's mentioned, the commercialization angle. Robin d has a question in it's quite long in a couple of parts, but let me be real quick. Can you comment on the prospects for the oral GLP one project, which is topical given the AstraZeneca deal announced yesterday in the space? Correct. That's with a Chinese partner. It was phase one data, and it was, I believe, a 180,000,000 upfront, if I recall correctly. Obviously, there are four major players in this space, mostly phase two, phase three. I myself a little skeptical of the patient preference compliant benefits of an oral versus injectable. Interesting. Can you find an out licensing partner for this asset and what additional data would need to be generated to make this a realistic prospect? Robin, thank you.

39:33 I'll try I'll I'll address that. As I say, I did talk about the deal yesterday with AstraZeneca. We love seeing deals in this space. I think it validates the interest that, you know, big pharma companies have, number one, in the GLP space. But I too maybe I disagree with you, but I think in the, you know, the oral delivery space as well. I think these, you know, patients who have to get, you know, your daily injections, they get tired of that really quickly. If you can replace that with an oral product, I think that makes compliance and, obviously, convenience a lot easier. I think from a, you know, from a partnering standpoint, you know, I said we've got our clinical trial protocols, you know, design, you know, in place, agreed, you know, documents, you know, submitting, etcetera, to the regulators going through all that aspect. These are very short clinical trials. I'd say it's essentially looking at your glucose tolerance test and looking for your drug, you know, in in in systemic circulation.

40:27 So, again, these are not long, lengthy trials. But from our discussions with pharma partners up to now, there's there is a clear interest in in an oral GLP one agonist. I think, you know, certainly, when it comes down, there's one oral drug to oral GLP one, I guess, on the market, which has a, you know, about a 1% bioavailability. So, that means only 1% of the drug, that you ingest gets into systemic circulation, which makes it cost a lot of money. That's a lot of cost of goods associated with that. So any improvements in that, I think there'll be really strong interest. Excellent. I hope that answers the question, Robin. Robin has another question here. As POOLBEG pivots into this new business model, we'll be focused on licensing and distressed clinical candidates for development. Is there an intended therapy area of focus for the new strategy? I think we, you know, we touched upon that.

41:16 Dave touched upon that. I think we'll be somewhat opportunistic is is one way to look at it. I think, you know, initially, you'll see as a company how we've, developed and evolved over the last, you know, two plus years, starting in infectious diseases, being opportunistic, looking at the the metabolic diseases standpoint, looking at oncology. So I think we'll remain to be opportunistic. And I think, Dave, maybe if you wanna comment on that as well. You you love your strategy, as you said. You know, these are kind of we make kind of good decisions and clear decisions on what's the right program to to bring in. But as I say, we'll, you know, we have the the team placed now to execute on that. So, Dave, do wanna Well, the only thing I would underline that you've said already, I would just underline that the goal would be to look for approved peri approval approved or or launched assets to drive growth and contribution, not to take on clinical risk and burn.

42:12 That is not the goal. In terms of therapeutic therapeutic area, I don't love the word agnostic to cut therapy area, but but let's talk about the underlying principle, which is if a disease has a clear high unmet medical need and asset has a value proposition to solve that need better than alternatives, immediate and near term alternatives, therefore, driving value to patients and the health system, we can be the stewards of that asset to get it to the right patients at the right time and ensure the pricing is appropriate and and drive growth and contribution. So that there's anything I would add. I don't I don't foresee us taking on a big phase three program with a a lag and burn Yep. And clinical risk. It's just that could be for another day if we're motoring.

43:07 But right now, it it's we wanna get off to the races. Yep. No. Great. I appreciate that answer. Okay. There's one here. I'll drop it in Kyle's lap. Jeremy, we seem to be moving towards Nasdaq more rapidly. Is there a rough time line of doing this, that you're aiming for? Look. I've always said we can't say when we'll go on Nasdaq, but I think it's the stated ambition of any biotech that really wants to grow substantially. Nasdaq has been on it. Say John McEvoy was critical and did lion's share of the Amrit drift or project to Nasdaq. So that has to be on our on our credit. We we simply can't put a time out, but it's on the agenda. Is that okay, Jeremy? I think that that has to cover it. So we have to be careful with how we speak to these, you know, specifics, let's say.

43:55 Sparky, Jay, good to have you on again. Hi, team. Congratulations on all achieved to date, and welcome to the new members. Is it fair to say we have multiple partners with an interest in progressing to signing a collaboration deal? And, also, do we still have aspirations to get on Nasdaq? Sorry. Colin just answered that second part. For the first one, yes. I mean, we are very BD focused. I think I mentioned the past. I've been twenty years in the industry, almost twenty one, but BD has been my focus. So we're always discussing with with PHARMA. We just got back from BioEurope this week, again, continued discussions. I think the oncology aspect I mentioned is really, you know, peaking a lot of interest. So, yeah, I mean, there's there's there's a good deal of interest there from from pharmas. And and, obviously, our ultimate goal is to, you know, have this trial, whether it is, you know, funded, whether it is, you know, getting option agreements. You know, there's many ways we could, you know, structure a deal where POOLBEG and our shareholders will will benefit substantially.

44:49 Question from Michael or what other uses, I I e, disease types, do you anticipate POLB zero zero one potentially benefiting? That's it's a really good question. I I know I said in the past about this acute inflammatory conditions, and these are, your diseases where you get this kind of an inflammation for, you know, a week or two, and, you know, then you can kinda manage it. We're not looking at things chronically, you know, like rheumatoid arthritis. I've spoken about it, you know, previously. But the one thing our intellectual property attorneys tell us, you know, not to name names, not to be specific about what diseases we will pursue because number one, that kind of will create competition in the space. But number two, it's may issue future patent filings when it comes to your prior art or prior knowledge. So we'll we'll we'll stay away from that one.

45:37 But I think we're just delighted with the data we got from, you know, from the the LPS challenge study. So any disease that's, you know, that has a p 38 MAP kinase component, you know, we'll, we'll be certainly looking for that because, again, I've mentioned before many times what pharma do like is, looking for drugs that, you know, have multiple uses. You know, they have from a commercialization standpoint, from a regulatory standpoint, from a manufacturing standpoint, there's many, many benefits to having a a drug, and we believe zero zero one could be attractive, in that regard. Question there. How does POLBEG it's from LRIP. How does POLBEG envision the potential impact of POLB zero zero one as a therapy for CRS within the current landscape of cancer immunotherapies?

46:22 Again, I touched upon this earlier on. We know I mean, if you rewind the clock and we covered this on Monday, you know, cancer patients, you know, back in the, you know, the nineteen fifties, again, not that long ago, you know, chemotherapies brought in with mustard gas, essentially what they were using to to kill off white blood cells, and we've progressed a long way since then. These new immunotherapies are game changing. You look at CAR T cell treatments, and you're actually you know, cancer physicians, you know, they try and stay away from the word cure. It's you know, as I say, you you don't mention the c word when you're talking about the c word, But what they're seeing now, certainly in in, you know, the CAR Ts and in the bispecifics, is that you're seeing this remarkable efficacy. But, again, it's managing these side effects. You know, getting these patient if they could, you know, get the drug in hospital and go home, that would be ideal. But what they have to do is stay in hospital with the, you know, the risk that CRS has developed. And, of course, they're monitored. They're taking up beds. It's a weight on the health care system. So I think, yes, there's, you know, there's there's lots of opportunities here. And you saw the slide where, know, you there's a lot of logos from pharma companies who are in this space. So I think it's you know, it'll be pretty exciting in that regard.

47:28 I think just a couple of more now, see we're we're kind of we're good for time. But do you think the use of cancer immunotherapy is gonna keep increasing? Is there other immunotherapies out there that zero zero one could be used alongside? I think the the short answer to the first is yes. As I say, it's a game changing new therapy in the cancer space. There's lots of companies developing their their bispecific antibodies, their CAR Ts, and, like, you know, and what they do and again, from a mechanism standpoint, the bispecific antibodies. So, basically, the two arms of an antibody, one of them binds to an epidermal protein on the cancer, and one the other arm of the antibody binds to a protein on the surface of t cells and brings the t cell close to the tumor. And and then the t cell sets to work and and kills the the cancer cell.

48:16 So what they're looking at now is, like, a whole host of antibodies that target different proteins on different cancers. So I think, yes. I mean, it's going to kind of explore and expand, you know, in that direction. And, of course, that there's there's always that, you know, concern out of CRS, you know, coming from that. So it's weighing the kind of risk benefit. I think, obviously, in a cancer setting, there's there's greater acceptability of the risks associated with the benefits because, you know, a condition, you know, can be terminal. So yeah. And other immunotherapies, yes, I say we we touched upon that. But, I think now for, you know, one last question, getting back to call for this one, from Jay Roberts. So, Carl, I see you're the largest shareholder in both HVIVO and POOLBEG. If you were if you were to buy more shares of one of these businesses, what one would be? I think I know yeah. I know what answer I'd give, but, anyway, call.

49:03 Jeremy, thanks thanks very much, and thanks to who Jay Roberts. Yeah. Look. I'll answer it by first of I started a little preamble where I came from because I know get a bit of dog's abuse at the time for maybe overhyping shares. But, look, I did do four IPOs. I've never sold shares in the market. I always wait until the company gets bought. So the share goes in between, and it goes back down. I always follow my money. I put a huge amount of my personal interest in Amrit. Yes. Could've got more, but I got cash when it got sold. Likewise, HFIBO. I've never sold a single share in HFIBO. Hopefully, one day, it may get bought. That's the time I leave. As regards POOLBEG, yeah, I think everybody can hear. I popped my head up again. Jeremy's doing a fantastic job. I did help Jeremy bring some of the AMOLED team in. I would have known them really well. So, look, there's a clear answer.

49:50 It is difficult as a director, as a chairman ever to get a window in small cap companies to buy shares due to insider trading rules. We usually submit information. But, absolutely, of the two companies where I'm a large shareholder as we speak is H. Vivo and POLBEG. We all invest in small cap biotechs to get that four, five x, 10 x. Sometimes it happens, and I tell you, sometimes it doesn't. My strong belief at the moment, it took quite a while to do AMRIT. I think the second time around with Dave, with John, with Laura, the team together, working closely with Jeremy, certainly, when I can get a moment and when I can get an opportunity as we go forward is that weeks or as months in POOLBEG, then free of this information. I would certainly like to buy more shows in POOLBEG. So, hopefully, Jeremy, this answers the question. It does.

50:38 Good to hear, Colin. Good good to hear the confidence. Yeah. So listen. We will wrap up their lunchtime. Know listen. Really appreciate, again, people's you know, you taking their time and their energies and efforts to to join us for this, IMC update. Again, very exciting time for POOLBEG, and, we'll keep you updated on future progress. But, again, enjoy your rest of your day and and the weekend, and we'll see you again soon. Thank you. Perfect. Jeremy, Carl, David, thank you very much for updating us today. Could I please ask investors not to close the session as you now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations? This will only take a few moments to complete, and should be greatly valued by the company. On behalf of management team of POLBEG PHARMA PLC, we'd like to thank you for attending today's presentation, and good afternoon to you all.

51:25 Thank you. Thank you.