Jeremy Skillington
CEO at POOLBEG PHARMA PLC
Replay available
Company Presentation hosted by Poolbeg Pharma (LSE:POLB) on Investor Meet Company. Replay available.

On 6ix: 6ix.com/event/poolbeg-pharma-plc-polb-company-presentation-2
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0:00 Good afternoon, and welcome to the POLBEG PHARMA PLC investor presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and could be submitted at any time via the Q and A tab situated on the right hand corner of your screen. Please just simply type in your questions and press send. Before we begin, I'd like to submit the following poll. Now I'd like to hand you over to Jeremy Skeleton, CEO. Good afternoon, sir. Good afternoon, and thank you for the introduction. And thank you everybody for joining us this afternoon for the POOLBEG presentation, of course, on the back of our r and s this morning talking about the interim results. Again, we have a fantastic presentation to go through to kind of update you on that. I'm delighted to be joined by my colleagues, Liam Tremblen, Ian O'Connell, and, we'll kick off, and, let's go through this. So as I say, we're we've got the a team with us today. I'll talk about the background, talk about the the companies that kinda set the scene. Liam will talk more about the clinical trial, the topical clinical trial. Let's say we've kinda announced the the positive interim data this morning. We're all delighted with that just as things are moving. We've got some terrific momentum now, so we're looking to kind of execute. And then I will Ian will speak more about the the commercial opportunity that we have here because, ultimately, we're looking for partners and partner in the program.
1:12 So we'll talk a little bit about that. So again, to set the scene, POOLBEG PHARMA, clinical stage company. We're developing POLB001 to potentially transform the lives of cancer patients, to allow them to have their cancer immunotherapy treatment safe and locally. And by doing that, we're preventing CRS as the plan. That's our goal to prevent cytokine release syndrome, and that means that they can take their their drugs from home or in the community. And we also have, an oral GLP one program that, we may touch upon later on. But, many of you know, we have a fantastic team here, a proven track record of deals and transactions, executing, you know, deals with big pharma companies, selling companies, etcetera. Very excited about the clinical trials that are pushing forward. And I said the focus today will be on POLB zero zero one and the topical trial try and these, interim data. And, again, clearly, the the goal of the company is to partner this program. We have a very clear path forward, what a what a phase three looks like and ultimately getting on the market.
2:05 We talked in recent times about meeting with the FDA earlier this year, so that lays out that groundwork. Again, we have some terrific ongoing discussions with both big and midsized pharma companies about the program and what it would take to move that forward. And as said, we're building nice momentum in that setting as well. And importantly then, we we had a fundraiser earlier this summer, so we've got a financial runway into q two twenty twenty eight. So that gives us a nice solid foundation for those negotiations. And as I said, POLB zero zero one, potentially the first approved preventative therapy for cancer immunotherapy induced CRS. We mentioned this in the past that cancer immunotherapy are essentially wonder drugs. They're driving cures of certain cancers that didn't exist ten years ago. So in essence, cytokine release syndrome didn't exist in this context. So it's a it's a large and growing issue for these cancer immunotherapy, and we believe that we have a drug that could potentially, prevent CRS, from occurring in these situations. And as and as I mentioned, ultimately getting these drugs into the community care, patients can take them at home. And it's a big unmet need there and a lot of interest in in what we're doing. And as a reminder, CRS or cytokine release syndrome, we see ourselves as having that potential solution.
3:16 It's a systemic systemic inflammatory side effect for these cancer immunotherapies. And again, in a nutshell, immunotherapies are redirecting your own immune system to go after your tumors, but you have these nasty side effects, including, you know, including CRS. What does that mean? Patients get fevers, they're they get increased heart rates. They get low blood oxygen, low blood pressure. And then that that can escalate into severe issues around kidney injury, neurotoxicity, capillary leaks, etcetera. So, again, that's a severe issue. If it starts, it's a bit like a runaway train. There's an issue where you wanna put your foot on the brake of train and kinda bring it back to normal. And as I say, with POLB001, we believe we can start stop that from happening in the first place. Now it is an oral agent given orally. It's a an inhibitor of an important immune control system called p thirty eight MAP kinase. It's a gatekeeper of that inflammatory response.
4:07 And I said, we want to inhibit these cytokines that drive that kind of inflammatory response. And as a master regulator of that inflammatory response, p 38 MAP kinase is is an excellent target in that context. And again, this drug has been in in humans previously. We've done our standard, you know, phase one single ascending, multiple ascending dose. So it's been in many people, many humans. And as many of know, we did an LPS challenge study a few years ago and saw excellent results there to prevent inflammation that's caused by a bacterial fragment, LPS. Now, again, it's important to look that, one of our significant advantages is we're given orlies. Patients can take our drug from home. They don't have to come into hospital and get an infusion or an injection of a of a, you know, a protein based drug, for example. But as I say, we're what what we're happiest with here is that the coverage and you can see here in the lower box, the red dots, you know, admitting that the font is quite small. What we're seeing here is POLB001 can inhibit a whole host of cytokines and far more than other drugs in this section can as well. Tocilizumab is given as a standard of care, you know, once CRS develops, You can see the red dots there. It's only a handful of these cytokines that it inhibits and far less than POLB001 can. So again, there's other drugs like dexmedazone, which docs don't like at all because that can have an immune suppressant side effect. And then JAK kinase inhibitor as well that's going to inhibit some, but not a lot of these cytokines. So we see advantages here for POLB001 in that setting.
5:36 And I mentioned, you know, about the, you know, this large and growing market of cancer immunotherapies. The box the graph on the left shows the expected growth in revenue of these many approved t cell engagers, they're called, and they come in two different classes to buy specific antibodies, which we are using in our clinical trial, as well as CAR T cell therapies. And as I mentioned, the efficacy they're seeing, particularly in the in the blood cancers such as myeloma, is very impressive. But as you can see in the table on the right hand side, these approved drugs, you can see the big pharma companies, J and J, who we're collaborating with on this topical trial, other companies like AbbVie and Roche, they have these bispecific antibodies approved and on the market. But as you can see on the right hand side, they have significant issues around CRS. These are are noted that teclistamab or tick failures that he's is here in our clinical trial. Seventy two percent of patients develop cytokine release syndrome. And I'd say for our topical trial, we're looking to kind of reduce that that number. But it goes across the board.
6:33 They know it's an issue. They know it's coming. They know patients have challenge, you know, with CRS. It's an added burden to the health care system who are there to look after the patients and their cancer, but now knowing that a large majority of them, can and will develop, cytokine release syndrome. So they're looking for solutions as well. And as you know, when we talk to, particularly clinicians in The UK about our work, there's a lot of interest in participating in our in our clinical trial. I do want to you know, there's a video here I wanna show. Bob Monroe is an actual myeloma patient, and Bob talks here about a minute, minute and a half about his his issues that he he had in the past with CRS. So I wanna bring, you know, our story to life and what the the challenge and issues are for patients. And my example a very good example, I had cytokine release syndrome.
7:19 It wasn't particularly severe, but it was very, very persistent. And, actually, I mean, it was actually during COVID as well, but that wasn't really the point. The point was I'd come in, booked in for a week. I'd get cytokine release syndrome after a couple of days. They'd have to delay the process of the the the drug. Very often, I'd get a a side effect like a childhood virus would reemerge into my body, and I'd have to stop the treatment again, which meant going booking another week to go back into the hospital, start the treatment again, the stepped up dosing of the bispecific, T cell engager, and I'd get cytokine release syndrome again. And this this process actually during my my experience in that first year, I spent a hundred days either in or at hospital because of the treat because the treatment had to keep being restarted, and they couldn't they had to keep an eye on me within a hospital setting in case this the cytokine release syndrome escalated into something more serious.
8:19 So that was a, you know, a lesson really that something needs to be done, if possible, to to to to stop you having to go in the hospital every single time. And what I understand, the the zero zero one, if it can dampen down the effects of a cytokine release syndrome, maybe get rid of them completely, it would prevent patients having to go into hospital for every single step up dose. It could be done in a in a regional hospitals or even at home in some cases. So I think there'd be a major break breakthrough for for the patients. Appreciate Bob's comment on there, because again, I think it highlights the issue of CRS and the fact that in a real world setting. And I'd say our goal here is to, you know, allow patients to get their drugs, and then as I say, go home, and then not have to kind of stop or start their treatments or, let's say, develop CRS these nasty side effects. So that's kinda me in an intro. I'll be back later on.
9:14 I'm gonna pass across to to Liam Tremblow to talk more about the the the clinical trial, as I say, from the RNS this morning. So, Liam, I'll step to the left. Cheers. Thank you, Jeremy. Really excited to speak to you all today with this really exciting news for the company. So I guess just as background for those of you that maybe aren't so familiar with the the the story of the company, but this is really the transformation that POLB001 is really going to make for these cancer patients. So these bispecific antibodies, if you look on the left hand side of this slide, typically, this is done in hospital. They have to be hospitalized for up to a week, and what happens is you give this immunotherapy, and it activates T cells. This drives the production of cytokines, results in cytokine release syndrome, and this happens through p38 MAP kinase signaling, and this is a potentially life threatening side effect that needs to be managed quickly so that it doesn't progress where if it progresses, it can affect virtually any organ system in the body.
10:07 In addition to this, if cytokine release syndrome does happen, that week of hospitalization could be extended. So if they have cytokine release syndrome, they can't get the next dose, and what tip they're in for a week because they have to get two or three doses, and these are small doses before they get a full dose, and this is purely to get the body used to it so that we don't have overwhelming cytokine release syndrome in these patients. So if cytokine release syndrome does occur, then they need to delay these step up doses. That week can turn into a much longer period, and, obviously, this is a challenge not just in the existing centers to administer it, but also making it more widely accessible to centers that don't have that resource utilization to have beds for these bispecific antibodies. Alternatively, the hypothesis with POLB zero zero one and and the solution that it will offer is that we can actually give this orally at home. They can take it before their cancer immunotherapy happens. It doesn't affect the cancer immunotherapy.
11:02 They still get the benefit of the therapy. They don't don't get this cytokine release. They can get this in an outpatient or at home setting. P thirty eight blocks the CRS, and by preventing CRS, then we actually reduce the hospital stay. We enable administration, particularly in community hospitals, and improve patient quality of life. And that community hospital piece is so, so important because, as I'll talk to in a moment, particularly in The US, a lot of patients actually can't access treatment in what we refer to as, you know, high or centralized hospitals. In America, up to seventy five percent of late stage relapse myeloma patients only get treated in the community care, which is very different to what we're used to. So getting into this community setting, critically important that we get this treatment out of the hospital setting.
11:48 So just a little bit more on the topical trial itself. Obviously, we're excited to share really good news on this. Just before we go into some of that, what is the trial? So it's a first in patient trial, as I mentioned, in multiple myeloma patients, relapse refractory, so quite ill patients who are receiving the bispecific antibody, teclistamab. It's been led by Doctor. Emma Serle, who's a consultant hematologist at the Christie Hospital in Manchester. It's been conducted by a blood cancer specialist organization accelerating clinical trials who are really equipped to deliver this as quickly. And we've made a lot of effort to design this trial in a way where it can be delivered quickly and equip it with teams that are able to to make that happen as well. So the trial is planning to to recruit about 30 patients, and down the bottom here is that, as Bob just spoke to, Emma, the chief investigator, experiences this day to day and the challenge that it presents to patients, obviously, on their quality of life, but also from her perspective that to get these treatments to more patients, you really need something that removes CRS, removes this bottleneck, and that's how you will access a broader population and get these life saving immunotherapies to the patients who need them.
12:55 So the trial, this on the left hand side is the design of what's happening in the trial, designed to be conducted quickly. So cytokine release syndrome, as I mentioned, happens when these patients are getting step up doses. So we have it here as TEK dose one, TEK dose two. That's teclistamab dose one and two. After these first two small doses, they get what we call a full dose, and it's during this period where we step up the level of the dosing that cytokine release syndrome occurs. So what we do is we we give the patients POLB zero zero one to take twice daily orally at home during this period, and then they can get these bispecific antibodies without cytokine release syndrome happening. So trial itself is single arm, which means that everybody in the trial is getting our our study drug POLB zero zero one, and it's open label. So the the data is available for the investigators to to read as it goes along. And as I mentioned, it's gonna recruit approximately 30 patients.
13:49 There is a partnership with J and J there for the provision of teclistamab, which we think is a really important endorsement to the program, that they see the promise of of this cytokine release prevention strategy as well. So endpoints in the study, what are we looking at? Obviously, the safety of POLB zero zero one is critically important. We're going into a a late stage cancer population who are severely unwell as the first time the drug is going into that population, so safety is a key focus. And related to that, we're obviously looking at the incidence and the severity of cytokine release syndrome. And then we're also looking at other things from a drug development perspective, like confirming the safety and the pharmacokinetics of the drug itself, and that pharmacokinetics refers to the level of blood and level of drug in the body before it's metabolized and it's eliminated from the body. So this is really important information as we go forward to make sure that these patients have an adequate amount of drug in the body. And and then we're also looking at things like how is CRS managed and how is tocilizumab used used because this tocilizumab is an IL six receptor quite often given by IV. There's a lot of pieces that go into CRS management that is quite burdensome from the hospital. This is reported in a lot of the biggest trials that happen across the world with these bispecific antibodies that revolutionize cytokine release well, sorry, multiple myeloma treatment.
15:01 So seeing all of that fall away is quite an important aspect of what we're doing. So we're not just looking at the cytokine release, we're also looking at a lot of that administrative burden and burdens to the patient falling away as well. So just to quickly mention, this is not a typical oncology trial. So, obviously, we're we're looking at multiple myeloma patients, and, typically, when you're doing a trial in this population, you're given a disease modifying drug. You're trying to prevent their cancer growing. You have to follow them for a long time. So while cytokine release syndrome would happen at the start of their therapy, you'd have to wait months or years to see how these patients respond, and as long as they continue responding, they stay on protocol. So that's why trials in this setting can typically take many, many years to complete. What we're looking at with the topical trial is actually we're only looking at the first section of the patient journey of cytokine release syndrome and when it occurs. So, basically, that's going to happen in the first couple of weeks. The patients will only stay on protocol for a month or two, and after that, they'll come off.
15:55 So as soon as we can get the patients through this process, that is the trial done. So as I mentioned, short term monitoring, one to two months. Open label, as I previously mentioned, really important. That's rapid visibility for the investigators that they know whether or not this drug is working, and as I mentioned, single arms. Every one of those 30 patients is receiving POLB zero zero one. So not like a typical trial where only half of your patients will get the study drug. So just to give you a background of what we've done to date, obviously, a lot of effort went into designing this trial so that we could deliver it rapidly. You know, we announced earlier this year MHRA approval. That was a long time ago. It feels at this stage a lot of work has gone in since. So we after that, you know, we made sure we had the right sites on board, that they had the right volume of patients, and also they had the right quality systems to conduct this trial and collect the data in a high quality manner.
16:46 That was validated by going to site initiation visits where we went and checked, really, these sites are fully equipped to deliver everything they do and to hold them to delivering a certain amount of patients if they want to partake on the trial, there's an obligation there where they're meant to try recruit as well. And as we've seen, as we're announcing today, you know, that designing the trials quickly has been validated, and now we're seeing certain sites really able to deliver patients quickly, which we're really excited about. So site activation occurs after all of that. Once site activation happens, that this is all CRO, so accelerating clinical trials led activities with the chief investigator. We really move into site level pieces, and this is patient identification, so typically what happens is you'll have a multidisciplinary team of specialists who sit once every couple of weeks in every hospital, and they'll go through all of their patients, and they'll identify patients who need to go on to a new line of treatment, and also who's suitable for a clinical trial. After that, you go to the patients and see if they want to actually participate on the trial, so we've got really good feedback that a lot of patients are really happy to partake in this trial, that it's attractive to them as well, which is a really important part of trial design. And then if they're willing to take part, the patients are screened to make sure that they align with the formal eligibility criteria of the trial, and then they can be recruited and dosed into the trial. And this is really where the substance of the trial happens. It's where we're at now. It's where we're rapidly gaining momentum as more and more sites come on board, and we're continuing to hopefully get that momentum.
18:09 And then, obviously, as we're announcing today that recruitment, dosing, results in interim data, and so we're really enthused with what we've received. So the clinical trial interim data, we're super excited. This is a major milestone for the company. Obviously, these are seriously unwell patients, and the the safety review committee have reviewed the data. They have announced that the the study can continue, no modifications to the protocol. So, obviously, they have a lot of faith that that that this is safe to continue with and that they have a lot of optimism that the study the study can go forward as it is. For us, obviously, cytokine release syndrome is itself a safety endpoint. So these are all really positive milestones, and the fact that the study drug can be administered as we expected in this really sick population is a really encouraging signal for us at this stage, and we're enthused by this. So as I mentioned, this is a really positive sign for the program as we position it to look at me scale up quickly, that it's attractive for partners and that it can get, as we mentioned earlier this year after the pre IND feedback from the FDA, that there is a clear path to market here that could happen quite quickly, and this is a key derisking point in the program that gives a lot of a lot a lot of confidence in the program and will also instill a lot of confidence in potential partners to really move forward with it. So we have a lot of momentum.
19:30 The recruitment is continuing. Even since having this news, we've already got news that there's another patient being dosed, which is just fantastic. So we really are thankful to accelerating clinical trials and to all the sites involved in in the trial to date, And the feedback so far has been really good. So we're super excited. Obviously, we'll be sharing this with with partners, but I'll I'll let Jeremy speak more about that. Yeah. Thank you for that, Liam. Yeah. Appreciate that. So listen, we were kind of nice momentum on a lot of fronts. On the business development front, we mentioned this previously. You know, we've we've had some really productive discussions with with several different companies. They're interested, obviously, you know, to see the outcomes of this interim analysis and as the the clinical trials develops. But I think what's, you know, important here is that, you know, as I said, we we see this and they see this as a derisking issue. So, you know, interim data we have now, the safety review committee has reviewed that, told us to kinda go forward, keep the same dose, everything is going according to plan. As Liam said, recruitment is going exceptionally well across the sites. We're excited with that.
20:30 And as said, we're building that data package from a a business development standpoint. I think what's interesting in that front is that, you know, we've in the background, we've looked at the commercial opportunity that this provides as well. That's one of the key questions I asked. Now Liam is gonna talk us through that aspects, and then I'll be back later on just to to wrap up. Liam or Ian, over to you. Thanks, Jeremy. So following on from Liam on the clinical side, as Jeremy said, we wanna spend just a few moments to run through the recent commercial work which we've done, again, which is strongly supportive of the program. So earlier this year, we commissioned Accumedis to run independent payer research in The US. So this was conducted in through by means of structured interviews with current commercial payers covering around 75,000,000 lives in The US. So pretty broad cross section of the markets right the way across commercial insurance, Medicare, Medicaid.
21:26 And this was again complemented by cost offset modeling whereby Acumedis were able to quantify the cost savings from avoiding the CRS related costs, such as hospitalization that Liam already spoke to. And the first thing that came back loud and clear from the payers was that CRS for them is an expensive problem and one that they recognize. Hospitalization, ICU use, length of stay, and acuity are key drivers of this cost. Secondly, the research found that an effective preventative therapy could support a broader outpatient delivery of these cancer immunotherapies. And, there would be meaningful access and cost implications for the payers if this was able to be affected.
22:17 And on POLB zero zero one specifically, they think that it's positioned as a commercially meaningful CRS prophylactic, or as what we'd say, preventative therapy, driven by reduced com hospital burden and broader outpatient use. So I think most significantly, the key insight was really that on the payer side, because of all these issues, there was a clear willingness to pay as commercially meaningful price points. So on that then, we'll flick on to the next slide, and you can see the conclusion of Chris Grimes Compton, who led the research at AcuMetis. And I think it's their pretty direct POLB zero zero one is positioned as a compelling CRS solution with significant market potential.
23:08 And because payers are able are willing to pay commercially meaningful price points because of all that all the factors that we've talked about, such as hospitalization, they concluded that taking into account the patient flows and the epidemiology of the condition that there is multibillion dollar peak sales potential in The US alone for POLB zero zero one. So, again, really significant commercial product, and, one one piece that really resonates with potential partners. So now that we've covered the validation of the commercial opportunity, I'll hand you back to Jeremy to talk about the partnering in a little more detail.
23:55 Great, Ian. Thank you so much for that because I think it's an important component. And for those of you, some of you might have been at the, investor summit last Friday, had a terrific panel there, that included, Mikael Broker at, the UBS. And he talked about what pharma look for, you know, what pharma look for in the the the deals that they send their scouts out to, you know, scour the world essentially to look for. And, you know, this is kinda summarized here quite, you know, quite accurately, you know, scientific rationale. Like and and we put this in the context of POLB zero zero one, like, are we checking, you know, these boxes? Do, you know, do we meet the needs that pharma look for when it comes to partnering? And I think, from our standpoint, you know, scientific rash rationale, absolutely. P thirty eight micrograms is a great target. You know, there's nothing out there to prevent, CRS right now, and we've got a terrific, preclinical and clinical data set. And, the clinical data is is obviously a very important component, and, obviously, that's where the topical trial is moving forward. And, again, happily today, as I say, we've kind of, you know, passed muster when it comes to that kind of first kind of interim safety analysis, which is terrific.
24:59 And, as we mentioned, you know, recruitment is going, and we're keeping at that same dose, the the the one fifty mg twice a day dose that, that we have data generated from. So, again, you know, we were also encouraged, the insight recruitment is pushing on. And we've been approached by other clinical trial sites in The UK that they wanna kinda join this trial as well. So great enthusiasm from the field because it's such an unmet need. From a regulatory standpoint, you know, how do you get this drug through, you know, the clinic and onto the market? That's And where the regulators come in, you know, the FDA, the EMA. And we mentioned we sat down with the FDA back in May this year and talked about the program, talked about what a phase three would look like. And they gave us fantastic feedback on, you know, guidance, what a what a label would look like, you know, where where exactly you can sell it and, you know, the endpoints for phase three. That gave us great kind of clarity or confidence. We're on the right track. And we share this with pharma all the time.
25:48 This is where, you know, the FDA thinks we're going. And, as Liam mentioned, particularly with the topical trial, these are short clinical trials. So, again, getting this to the market quite rapidly is is, very exciting to, to a lot of people. Intellectual property, key component in this industry. And, we've had several announcements this year of patent grants, you know, across, you know, Canada, Europe, South Africa, Australia, and notice of allowance in Israel. So there's great confidence that we have protection. We have exclusivity when it comes to once we get it on the market. And Ian spoke about the the commercial validation. You know, it's an unmet need, and I said earlier on, it's a relatively new space because cancer immunotherapy drugs are relatively new. So they're they're going and growing. And again, big market, large unmet need, multibillion dollars in The US. So as I say, we have a lot of kind of compelling, discussions with, with big pharmas, I mean, some mid sized pharma about the program and just kinda moving that forward. And I think we're we're excited where we are right now and say from a, you know, the clinical trial standpoint and, building up that bit of competitive tension, you know, about, getting the partners into, our data room to do their diligence.
26:52 And, this is a slide, again, I borrowed from from Miguel, you know, from the conference last Friday, but pharma is under pressure. They have a patent cliff coming where a lot of their, you know, big selling largest selling drugs are going off patent. There's a list here of when they go off patent from, you know, 2026 to to 2032 to '33. But about $400,000,000,000 in revenue for big pharma goes off patent, so they lose exclusivity. So they need to find other drugs to kind of fill those gaps, fill those holes. As there are discussions with, with partners, it's like POLBEG zero zero can do that. You know, we can generate revenues. We mentioned markets is, you know, you know, 10,000,000,000 in size and, you know, over 2,000,000,000 in revenue. So it'll plug a little bit of that hole. So big unmet need for pharma. And as I mentioned, we have diligence ongoing, pharma, you know, companies are are in our data room. Again, the the font size here is quite small, but we've got, all of our documentation, you know, in these virtual data rooms online, they can access and review. So we call it their doing diligence on the program to understand everything we've done so far. So as I we're gonna build up that story, build up that, you know, competitive tension, and ultimately, the goal is to is to transact on POLB zero zero one. So you know, executing, and I think that should come through in this presentation. There's been fantastic execution of the clinical trial in in 2026.
28:21 And again, with thanks to to Liam, Mina, Paul and the team for, you know, for driving that forward along with our collaborators such as ACT. And again, very exciting, with the with the stage of the programs and moving those forward. Again, high value with large unmet needs, and, again, partnering focused. And, again, a reminder, we have, cash runway into q two twenty twenty eight, which, gives us that buffer period where we can negotiate, strong deals, attractive deals for POOLBEG and our investors, and, looking forward to the the next stage of the company. So again, appreciate all of your time, this afternoon. We'll wrap it up there from the presentation standpoint, but I do wanna get to questions and, again, appreciate those that have submitted. We'll go through as many as we can in the next ten or fifteen minutes or so. And, again, appreciate input in advance from from Liam and Nim as as we as I read out these questions.
29:10 Alright. So the first question came in I I like it short and to the point. Is this what you expected? Well, personally, you know, I'd say this. I mean, we're happy because things move forward. But, again, maybe I'll I'll point to Liam to kinda give in a bit more kinda detail to, you know, what the expectations were and what this kinda readout is. Yeah. So thanks, Jeremy. So at at this stage of the trial, this is you know, we're really excited by this news that we're going into this sick population and and the trial can continue with the safety monitoring committee. So this is really positive. It's a major milestone for us. I think it's a major milestone for for the program, and it gives us a lot of encouragement pushing forward. So so, yeah, it has to be considered in in the context of of where we're at. This is the first time going into late stage relapsed refractory myeloma patients.
29:56 These patients can be severely unwell, and being able to deliver the drug in a way in which the committee feel is safe is a strong endorsement to the program. So we're really excited as the program moves forward, and it gives us a lot of encouragement. Super. Alright. I'm going around the circus. I should say, Liam and I are in Glasgow right now. The International Myeloma Society meeting's on, so a lot of good discussions here as well. So appreciate that. So the next question is quite lengthy, but I I'll kinda read through it. Today's RNS describes the interim safety review as positive, correct? Without asking POLBEG to disclose anything commercially sensitive, can you give investors more detail on what the interim cohort actually showed, particularly the number of patients treated, CRS incidence and severity, and whether there are any early signs of POLB001 having the intended biological effect.
30:47 I'm aware this phase is focused on safety, but often there's additional clinical indications to share. Thank you so much for kind of writing out that question. Again, I'm going to look to Liam to address that, but obviously, the commercially sensitive aspect as well. We're very, as I kind of deliberate in what we're allowed to disclose? But, Liam, if you can kind of address some of that. Yeah. Absolutely, Jeremy. And so the investigators are as Jeremy mentioned, we're actually at the International Myeloma Society meeting now, and and a lot of the investigators in the topical trial are here. They will be meeting tomorrow. They'll be going through all of the data in detail that the same safety monitoring committee went through. So this is you know, the patients going in, we have really good momentum. We're gonna give updates as that enrollment picks up, so we'll keep everybody up to date on what goes. But the fact there's no change to the protocol, cytokine release syndrome is essentially a a safety endpoint as well, which needs to be borne in mind. So that it's safe in this population is really positive. This is a major milestone, as I mentioned.
31:44 I'm really encouraged to to move forward. Thank you for that, Liam. I'm going around circles. Why did you run this study in The UK? That's a really good good question. We had and I'll go back. Something maybe historical. We had some really good interactions with Emma Searle a few years ago. And Emma, as you know, is a principal investigator, a co co principal investor on this study. And when we brought her idea to Emma, she kinda seized on us immediately. And she saw again, she's at the cold phase. She's seeing these multiple myeloma patients, giving them these bispecific antibodies, seeing the CRS develops. And she saw straight away the potential. You can give a small molecule or already available drug to patients. That would be great to reduce CRS. And I think one of the reasons we have in The UK is because there's such a really good tight network of myeloma hematologists and myeloma docs. Emma reached out to Rakesh Papash down in the UCLH in London. And he's a, you know, a key opinion leader in the space, and he wanted to join this study. And they ended up reaching out to Charlotte Poland in the Morrison.
32:46 And, you know, so we kind of built this early momentum, and we recognized from a trial design standpoint, we needed 30 patients. And it was realistic to that we could achieve that goal relatively rapidly, and Liam went through this as kind of a rapid study in The UK with with Emma and her, you know, colleagues to collaborate. So we have the six sites in The UK as as we mentioned. We have you know, but as said, we've been approached by others because the network in The UK is so tight. So I think it's a fantastic for this, you know, particular trial. I will comment, you know, for the phase three design that we have mapped out and discussed with the FDA and indeed kind of introduced to pharma companies. That will be a global study. We're looking at many more patients, and obviously you want to go global and test it in other centers. But I will say once we kind of introduce that concept or idea to other clinicians in, you know, other other hospitals across the globe, particularly in The US, there's strong interest to participate.
33:40 So again, we're trying to be seamless in, you know, as we're kind of moving through this clinical trial, plan the path forward and and build that. So again, appreciate the question there. So that's that. Question, how many patients have been dosed with POL one to date? Again, that's a good question. I mean, when you think back to, you know, for this particular study, you know, the numbers are relatively small. And as I say, there's we're we're going to dose upwards of 30. I think the plan from a timing standpoint, we'll have all that done, wrapped up, completed in the first half of next year. You know, that's our you know, we believe as things are kind of moving forward, particularly if other trial sites come online. So I think it's moving along quickly in that sense. So, you know, again, we're trying to get this into as many patients as possible. And, of course, we're highlighting it's been in many human subjects, you know, healthy volunteers over the last number of years for the various studies that were done with POLB zero zero one.
34:33 Next question. Again, I appreciate the questions. Are discussions taking place with potential partners now, and is a deal possible before the full results? I'll I'll take that one. I mean, you know, Ian can weigh in as well if if he'd like, but for for that one, absolutely. You know, we you know, there's all there's you know, I've been in this industry for, you know, twenty three, twenty four years. They're always gonna talk about, you know, how deals get done. You know, it's not an overnight, you know, discussion. It's, you know, it's building confidence in the program, sharing details, sharing information. You know, every, you know, patents that's granted, you know, we we notify our potential partners on that. And we do have a have a long list of people who are engaged, people who are kind of reaching out. And as I say, we we wanna time it right that we have sufficient clinical data, you know, in the topical trial that derisk the program and also, you know, kinda syncing that up with the actual value of the program, what other parties are willing to pay.
35:29 And there's a nice kind of a, as I say, negotiations going on in that sense and when is the right timing. But, you know, there's always discussions going on. We're always updating them. And I think, you know, before the full results, this is where the competitive tension comes in. People realize that if they don't pull the trigger now, it'll be gone soon. So there'll be, there'll be good, good discussions, as I say, from various, companies. And each company has has a different perspective. You know, some of the big pharma companies might wanna pair this with their drug and their drug alone, but then you have cancer supportive care companies who would like to get POLB zero zero one on the market and to be used with all t cell engagers by specific CAR Ts. So a nice little bit dynamic, but as Ian went through, it's a significant market, and I think, you know, we have the potential to be the the first orally available small molecule drug to prevent CRS.
36:16 So again, I appreciate that. Next question, when are the full results due? Again, I talk I talk to that about, you know, that's linked to patient enrollment. We're happy with the rate of enrollment right now as the as the sites progress. As I mentioned, potentially quicker if additional sites come on board, and we're doing diligence on that. And, again, appreciate the work that, Mina, Liam, and Paul are doing to to drive those forward as well. Another, business development question here, what is the ideal deal structure? One partnership, multiple partnerships, or a buyout? Ian, do you wanna take that so I can kinda rest my, my my vocal calls a little bit? Yeah. No. And good question. Appreciate that. The best deal for POOLBEG is really the one that yields the most value for the shareholders. So we're, as Jeremy said, continuing to engage with the potential partners.
37:08 We're fortunate in that the bits are nicely falling into place. We got the clinical data. We have the path to market now validated with the FDA with the commercial work done. So what we'll be doing now is really beginning to push on and engage to see which path will yield the most value. I think we're somewhat agnostic whether it's, one partnership, multiple partnerships. It's really about maximizing the value of what we have, which we think is quite an exciting package in POLB zero zero one. Jeremy? Well well said, Ian. I couldn't say it better myself, and, again, appreciate the the water break. Very good. Next question. Again, appreciate these coming in when and again, we we'll try to tackle as many as we can. Is POOLBEG interested in targeting other problem areas affected by CRS, such as COVID and sepsis?
38:01 What other areas can POLB zero zero one potentially address? And is there a role to play in autoimmune conditions? Listen. Wow. We could spend, you know, quite a while talking about that. I think that the the short answer is yes. You know, we're very much focused on, as I said, the cancer immunotherapy induced CRS. I think that's where our, you know, we have our best knowledge. We file intellectual property. We do know, and I think a lot of people, you know, you know, remember back in in COVID where, you know, cytokine storms was also an issue. The sickest patients had cytokine storm. The difference is that we're preventing something from happening with the cancer immunotherapy is we know patients know when they're gonna get their cancer immunotherapy drug. So it's a much more better controlled clinical trial. But you could see potentially kind of down the line in the past, you know, kind of giving it after the event, you know, and say the cytokine storm has started. So that's kind of planned for the future, and of course, that could open up a whole, you know, potential kind of other market area.
38:57 And I think somewhat ironically, you know, some people may remember, we started, you know, as in the infectious disease space looking at severe influenza. But from a commercial and market standpoint, the unmet need in, in cancer immunotherapy induced CRS is far greater. So that's where our focus is right now. So again, appreciate the questions. Auto autoimmune conditions, yes. I mean, we know there's, you know, inflammatory or auto inflammatory. Again, a lot lot of work needs to be done there from that standpoint, but very focused on executing on a topical trial. Again, deal work, you know, collaborations, partnerships, and then that's probably a discussion that we'll have with our partners on the line. So, again, appreciate the question. Next question. Following the recent US trip, Jeremy alluded to pharma having discussions with banks. Can Jeremy tell us a little more about this and what type of pharma companies?
39:46 Again, appreciate the question. I I mentioned earlier on, so we we we had some good discussions. Ian and I were at the HC Wainwright conference in New York last week. A lot of, you know, investors in the room, you know, there was kind of pharma companies present. There was, you know, biotech companies presenting. And, you know, what, you know, what we've kind of found, and again, this came from a discussion we had with Mikhail Brokers at UBS, is that they're in constant discussion. The banks are in constant discussion with pharma companies about what they're looking for, what does pharma need. And as I say, we showed the slide earlier on about the 400,000,000,000 that's, you know, falling off their balance sheets when it comes to patent, expiries, you know, that, they're concerned about. So they'd look, you know, to, what companies are out there, what companies have, you know, impressive data, clinical stage, could fill a gap, you know, so really good discussions around, you know, what pharma needs. And then we're lining that up, as I mentioned, in one of the slides about, understanding that is important.
40:43 And, obviously, we're having that dialogue, as well with the big pharma companies who have the the cancer immunotherapies. So, again, it's it's a nice it's kinda fascinating. And when the question, what type of pharma companies? I would say all. Everybody has a has a hole to fill when it comes to, your patent expertise. So, you know, our our plan is obviously POV zero zero one will fill some of that, the hole that's developing. Appreciate that. When is the GLP one oral study due to begin? We've, we've talked, I was speaking recently this week with, our colleagues at Anabio. As you know, it's their encapsulation technology that, is encapsulating the oral GLP one. Given orally, it's protected from the stomach acids and enzymes, and then it's released into the smaller intestine. There's discussions going on with the manufacturers, with the principal investigators about, you know, mapping that out. So we still have kind of h two on the, you know, on the on the critical path, you know, the second half of this year to get that trial moving that. And again, you know, you know, I won't ask Ian to comment on this, but we've had fantastic discussions with, you know, partners or potential partners late who are inquiring about oral GLP one. They're in the these are the large, you know, companies that are in the injectable GLP one space are looking for oral alternatives.
41:55 You know? So we have again, maybe you could say similar to zero zero one, We're kinda lining up interested parties before we have the data in hand. And then when we have the data, things will accelerate from there. So, again, appreciate that. Next question. I guess this we go back to Liam, and I think we we may have addressed this already. How many clinical sites are now live or planning to go live with patients recruited for a topical trial, and why are they appearing to take so long to go live? Okay. Yeah. Happy to take that, Jeremy. So we announced earlier in the year there's gonna be six sites. We already have a number of sites activated. There's two or three still still to activate. That's very normal for a trial like this. They're they're always phased. What we try to do is we try to get the most engaged, motivated sites open first that are gonna recruit more strongly, and then once they're open, the resource goes into opening some of those other sites. So there's a combination of just a practical perspective that we wanna get this recruiter as quickly as possible.
42:51 There's a little bit of strategy behind how we do that. So it's not unusual with six sites that there's normally one. We are hopeful that everything's gonna get sorted now in the next month. I think that the momentum that we have here at the moment in this announcement, we have the investigators meeting tomorrow. This is competitive recruitment for the trial, meaning whatever site recruits them first recruits them first. There's there's no there's no quota for every site per se that will be held back. It's whoever recruits first will will conduct the trial, and everybody really wants to be part of this trial. So all of the investigators, we've got a great relationship with them. They really wanna open their sites as quickly as possible, and and and we're really encouraged that that that this momentum is gonna translate. And, obviously, as those sites come on board, we expect the recruitment rates to get even even faster as we go forward. So we'll definitely keep you guys updated as as that progresses.
43:37 But for today, we're really happy with the momentum we've had, and we continue to engage the investigators exceptionally well. And I think they're really enthused to be a part of the trial and and results to date and the safety monitoring committee review. Obviously, that they can continue the trial uninterrupted from a protocol perspective, again, gives them reasons to be really enthused with the trial and want to get this done as quickly as possible. And they know our perspective that there is as I mentioned earlier, there's there's a quick path to approval here. Jeremy just was asked a question about other indications, and, of course, this is an anti inflammatory drug. There's there's lots of places you could say where that might be beneficial. Obviously, it's not always in shareholders' interest for us to say all of that because if it's announcement later, but there's definitely look, there's a lot of discussions that we're having here. You could you could even look at something like this if it was to get later as a pipeline and a or a product in a pipeline or the other way around.
44:27 But, definitely, these are things that, you know, we think there's a lot of potential in this drug if we can get it through this this gateway. We we've seen the value proposition for you guys that we really wanna position this optimally, but it doesn't mean that that's the that's the full extent of where we see this drug going. So really encouraged, and I think a lot of the investigators are are sharing great ideas with us as well of how we accelerate this and how we get more done quicker and how we increase the value for you guys. Yep. I I I like that answer. I like that answer. That's good. Again, I'm I'm cognizant of time. We're forty five minutes in, but we we'll keep going for a few more, and we'll try and answer as as many questions as possible here. What intellectual property do you have on encapsulated GLP one, and can it prevent it from being copied? Again, appreciate the question. Are, your collaborators and a bio have filed and granted patents around the encapsulation technology?
45:18 We mentioned in the past, they they have marketed products in, more than nutraceutical space, you know, encapsulating probiotics and and iron and vitamins. You know, that's kind of on the market. They believe they have a, you know, a strong patent portfolio, as said, with granted patents. And the the GLP one is kind of a separate section. And I think when we started collaborating with Anabio, the GLP one we used was off patent. So that means we could kind of freely use it. But I envisage that as we kind of move forward with the programs that, you know, taking other peptides and encapsulating them, that creates new intellectual property as we go itself. You know? And they have a lot even belong besides granted patents, they've got a lot of technological know how, you know, secret sources almost that they can kind of protect and nobody else can, you know, can copy because of their strategic approaches. So I think that's that's in pretty good shape for that.
46:10 Next question again. Considering today's positive news, can you give us a ballpark figure of what pharma company would have to pay to totally buy out POOLBEG? That's that's a great question. That's a really good question. I'd I'd love it to to be multiple. As I say, we've, you know, obviously, we're a public company. The market cap is out there. There's obviously premiums come with with a lot of these, deals as well. That's all part of the joy of negotiating. You know, we've all negotiated, you know, strong deals in the past. I think what'll, you know, what'll drive this is the competitive tension I mentioned earlier on, where you'll have a series or a host of companies who each want the technology and they can kinda start bidding against each other. So while, you know, we never kind of write a number or announce a number because, you know, you don't wanna draw draw a line in the sand, but we'll continue to drive the program forward to derisk the program. And there's a direct correlation between derisking and and value creation, and that's the the direction we're taking right now. So, again, we'll keep kinda pushing, and let's say that the ultimate goal is getting the best deal for, for shareholders.
47:13 But as I said, we've we've pulled a lot of the aspects together of, of a deal to make it compelling. So, we push hard, there on the valuation of that. Question here. Are there any other patent applications outstanding for POL zero zero one? And if so, which ones are they? I think maybe this is referring back to the influenza story that we talked about. And and I will say that we are kind of working on another aspect. Again, we won't announce, but we do see, you know, zero zero one having, you know, potential in other areas, we're kind of, you know, drafting in that area right now. So, again, the goal is, you know, I like Liam's kind of comment about the the pipeline and the product. You know, you can use the same, you know, drug for many different indications. And, obviously, we we'll see where we go from there. But, again, appreciate the question. When do you I think we've answered this already. The whole topic of trial be completed.
48:00 From Mark, oh, how many of the 30 patients are actually in the mentioned one to two months dosing trial process? I'm not sure. And how many of the 30 patients are actually in the mentioned one to two months dosing trial process? And when will the first patient trial results data be announced and released? I can, you know, I I think I understand. I mean, you know, we've the trial has started. We've reached that interim. We don't announce individual patient data, although many of you might have said I might have seen the Daily Mail, I think it was, did a profile of the first patient in, the Christie in Manchester who had a, you know, a very positive experience on the trial. But again, the whole point here is kind of, as I say, take the from a statistical standpoint, take the data as a as a whole rather than individual and kind of build it forward. But as I say, we're making good progress. As Dean talked about recruitment, we're very happy with that and, you know, kind of pushing off from there.
48:56 Another question, Adam. You continue to reference strong engagement from investigators and trial sites. Correct? Can you elaborate on the level of interest you were seeing from the hematology community and whether that has influenced site activation plans? Liam, you you know, I know you kind of addressed, you know, some of that. I I can, you know, I can kind of comment that, you know, I mentioned this earlier on, that as Emma started ball rolling and kind of reaching out to her, you know, hematology colleagues, we've got the pieces together. Once we got MHRA MHRA approval, then we had kind of, you know, inbound inquiries. You know, other investigators in The UK asking to participate in this trial. Some of which we've done diligence on the sites, you know, some of them take longer to get up to to speed, you know, up to, you know, get the site approval, etcetera. But we've been pleasantly surprised by the, you know, the additional sites that have come to us. And one of which we're we think, will come on board, you know, kind of relatively soon, all going well. So we'll keep working, Neo two. And again, that will help with recruitment and pushing out from there.
49:56 Question from Kevin. What is the evidence that dampening the CRS response will not also impair the antitumor efficacy? Really good question. I'm gonna get Liam to kind of, to address that one. But that's a really, really clever question that we've taught a lot about. What was the question? Sorry, Jeremy. This one the one up here. It was the about dampening the efficacy of the antitumor. Okay. Sorry. I missed that. So, obviously, that's a a key piece of of this development program. There's no point preventing cytokine release syndrome if you blunt the efficacy of the immunotherapy. So it's a really good question. What I can say is we've done a lot of preclinical work around this, and, obviously, it's a key question that investigators ask before you go anywhere near a patient.
50:42 Obviously, these patients are are they're late stage relapse patients. They need these treatments to work. They're not gonna go on a clinical trial for a CRS preventative unless there's a high level of confidence that we're not gonna negatively impair that. Obviously, we're early in developments, so we're phase two. There will be more evidence generated, so I'm not gonna put anything definitive out there, but, you know, we're very optimistic that we don't think this is a major issue at the moment. But, look, that's a different question than that's a regulatory question. From our perspective, we started this program as well because we saw signs. We we realized that this would be a really good fit as a preventive c for CRS, specifically because there's actually a lot out there to show that if you inhibit p 38 MAP kinase, you can dampen down cytokines without having any impact on T cell killing, and that's a key part of the hypothesis.
51:32 So if in T cell engaging therapies, obviously, you need the T cells to actually bind and kill those tumor cells, or in the case of a CAR T cell therapy, the the T cell is the therapy. So that's essentially important. So that's something that we've considered from the earliest days of this program. It it's evidence that we have collected. We have presented some of our conferences, and so it's something that, you know, we have answered before. I'd I'd welcome people to look up our data on it, but we're, you know, we're in a strong position there. Cool. Thank you for that. Yeah. Really, really good question. I appreciate that. Next question, will POLB zero zero one be given as a single course prior to first anti cancer treatment, or will multiple courses be given with each immunotherapy course? Again, really good question. The the design of the trial, we've kind of mapped this out we've talked about before. The patients receive you know, they take POLB zero zero one.
52:24 It's twice a day. You want to inhibit the target before you get the cancer immunotherapy. So you take the drug, you know, for several days in advance of the the immunotherapy. And this actually works well because patients take it from home. Let's say, on a Friday, they'll take the, the POL zero zero one, they'll take it twice a day, and then they'll come in on the, you know, the following Tuesday or so to, to take the cancer immunotherapy. And, then they stay on that. As said, they stay on our drug for another, ten days or so to keep the immune system calm and under control, you know, while they're also receiving their cancer immunotherapy. So I think it's a it's a balance. And then we're done. We'll say it's like, you know, just a short course of treatment for zero zero one to inhibit 30 MF kinase for a short period of time, and then the cancer treatment goes and does its work. So, again, you know, appreciate the the question there.
53:14 I think we've answered that one. Yeah. I think, you know, just around the the number of people being dosed. As I said, we're kinda happy with the progress. The the results, you know, are there. We can't say specific numbers, but I think, as I say, we'll have the the full kind of 30 all done and dusted. As I said, the the plan is in the first half of next year. So you can extract it backwards from there. In order to access The US market, would you have to carry out larger clinical trials in The US? And how long will this take months or years? Again, really good question. Now we're looking at the phase three trial here. So assuming success of this topical trial, we've got and this is what we discussed with the FDA, what that phase three looked like, how many patients that it looks like. It will be, as I mentioned earlier, on a global study. So where we want to and for for two reasons, you wanna get it into as many, you know, patients, but as quickly as possible.
54:04 And, yeah, that was a feedback from from the FDA. It's, you know, as I say, we'll you know, we've talked to kind of contract research groups who run these clinical trials, so we have a good understanding of budgets and timelines. And again, I'd reiterate that we're only looking at that first, you know, one to two months of patients when they receive, you know, our drug, and then we're done from that patient's perspective. You know, they'll remain on the cancer drug, so that'll go into a few years. So I think that it is a very short period of time compared to other clinical trials. And I think that's what's very attractive from a partnering standpoint as well, because we could have this drug on the market in in a relatively short space of time. Okay. And now we're my voice is about to go, but, again, appreciate everyone who stayed online. I know we're way over time, but I did want to address as many questions as possible. Who are your main competitors? This is from Bruno. Who are your main competitors in this field, and how far ahead do you think you are currently?
54:58 I'll kinda start. George, do you wanna do you yeah. Liam can take that. I'll I'll rest my voice a little. Okay. In terms of what's in development for cytokine release syndrome at the moment, there's actually an incredibly sparse competitive landscape out there. So we're definitely the the preeminent piece. There's there's some things that are being used in in the clinic, but there there's no development pathway for them. So they're not on they're not on the way to an approval. So this the topical trial is is able to push on, we're able to get positive results and push ahead with our program, we really will be the first preventative for cytokine release syndrome. There's a couple of things in the clinic, but they're all actually investigator led clinics for the most part unless I'm mistaken. So being investigator led generally means that there isn't a finance company behind them to really drive them forward. Sometimes these are repositioned things and that they might be available for a different indication being used off label. But quite often, the the company manufacturing those drugs isn't necessarily going to push forward from the IT. It can be done fully by the investigator.
55:53 So from a company perspective of a development program with cytokine release syndrome and, again, this is because you you need the right drug to come with cytokine release syndrome, that you need to be able to prevent cytokine release, and you obviously need to not impair the therapy, so have no negative impact on T cells, and you need an exceptional safety profile. The whole hypothesis here of this drug is actually to transition this to an outpatient, to an at home. We can only do that if you have a drug with an exceptionally safety exceptional safe safety profile. There have been other things that have looked at this area before, like people looked at one of our slides that we commonly use as the the cytokines that POLB zero zero one inhibits compared to tocilizumab steroids, but the third one on that list is of mitasinib, which is a JAK inhibitor. And JAK inhibitors can blunt inflammation, but actually, you get high levels of cytopenias, which means your your blood cell your immune cells in the blood go down really low, and then you're actually exposed to infection when that happens. So, again, this is something where it could be effective, but particularly when you're looking at that preventative approach, those drugs aren't suitable.
56:55 So we've we've got a really strong position here at the moment to kick on, and that's why I think a lot of people are really interested in this program. A lot of partners would love to be a part of it. Super. Alright. We'll wrap it up there. Again, appreciate for those who stayed on. We we did cover as many questions as we could. Again, happy to address questions offline if people have something to you know, that's on their mind or maybe something that kinda, you know, comes up, you know, after, you know, after the call or after the the discussion. Again, a great day for POOLBEG. Very happy where where we're at right now from the topical trial standpoint. Great to get the the go ahead, as I say, from the the the safety monitoring committee, you know, staying on the same, you know, dose that we have, you know, terrific. And I'd it's great for great for patients as well. So looking forward to updating you on, you know, more of our, you know, activity as as progresses.
57:43 And, again, I wanna appreciate, you know, or acknowledge, you know, Ian and Liam's, you know, presentation aspects as well. Because we've covered a lot in this clinical trial or in this presentation, so we're gonna appreciate your time for that. But looking forward to updating you more in the future. So thank you. Cheers. Perfect. Thank you to the team for updating investors today. Could I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback? On behalf of management team of POOLBEG PHARMA PLC, we would like to thank you for attending today's presentation, and good luck.
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Principal Scientist at POOLBEG PHARMA PLC