Good afternoon and welcome to the Poolbeg Pharma PLC full year results investor presentation. Throughout the recorded meeting, investors will be in listen only mode. Questions are encouraged and can be submitted any time via the Q&A tab situated on the right-hand corner of your screen. Just simply type in your question and press Send. Company may not be in a position to answer every question received during the meeting itself. The company can review all questions submitted and publish responses where appropriate to do so. Before we begin, we'd like to submit the following poll. I'd now like to hand you over to Jeremy Skillington, CEO. Good afternoon, sir.
Good afternoon. Thank you for the introduction. Appreciate everybody joining us this late afternoon. Finally a bit of a sunny Dublin. It's, you know, bleak winter is over. We're delighted here to be able to present on the back of our full year results announced this morning. Company update, company presentation, let you know where we are with particularly in POLB 001 clinical trial. Again, appreciate you joining us this evening. I'll be sharing presentation duties tonight with Liam Tremble, our principal scientist, who will talk more of the POLB 001 clinical trial attributes. Just to give a setting, just a grounding, a reminder, Poolbeg, we're a clinical-stage company developing POLB 001 that we believe has the potential to transform the lives of cancer patients by delivering these cancer immunotherapies in particular safely and locally.
There's a big unmet need. There's a lot of issues around cytokine release syndrome associated with cancer immunotherapies, and we believe we have a solution for that, and we'll talk a little bit more about the scientific and medical rationale for that later on. We're also developing an oral GLP-1 for obesity treatment we'll touch upon later on as the oral GLP-1. Again, very exciting space to be in. We are an AIM-listed company listed in London, and we believe we've got a strong investment case. We've got a terrific team here behind us, both on the, as I say, the, you know, the clinical, the business development, which will be critical, and I talk a lot about that, and of course, on the corporate and finance side as well.
The clinical stage programs we're developing, getting into the clinic, these are clear, large unmet medical needs and large growing markets, and we've done an in-depth analysis, particularly on POLB 001, again, we'll touch upon later on. We're very excited about to get these moving forward. We have financial runway into 2027, so we've got a, you know, several key clinical inflection points coming up. We're, we're funded through these clinical inflection points and into 2027, and that gives us scope then for partnering, for collaboration and licensing discussions. Again, we have had many discussions with potential partners over the last several months. Again, I'll touch upon that later on. There's a strong interest in what we're doing, strong potential to secure partnerships.
Of course, what comes with that is, you know, financial revenue, and we'll touch upon that later on. Right now we're certainly in clinical development execution mode, particularly with POLB 001. Over the last six, nine, twelve months, we've been gearing up on the partnering aspects, talking to a lot of big pharma companies, mid-sized pharma companies, and again, pitching and promoting Poolbeg. We've got high value programs with strong IP. Those of us, those of you who have kind of followed Poolbeg have seen the RNS is talking about IP grants and very important in this industry. The proof of concept clinical trials we touched upon are ready to be begun. Touch upon timing of that later on.
In the end, what we've built thus far with regard to the programs, we've got very high quality and compelling human data in the POLB 001 setting. Again, touch upon that, Liam will cover. Again, our discussion with partners have gone exceptionally well. They're very keen obviously. They see the value inflection point and the de-risking episode will be the clinical data that we'll read out in summer of this year. A summary of what we announced this morning in our annual results. We believe 2025 was a transformative year for Poolbeg. We really got ourselves kind of focused and driven and aligned with not just the market, but the clinical community as well, the cytokine release syndrome community in the cancer immunotherapy space. We finished the year with GBP 7.7 million sterling in cash.
Again, a healthy cash position. That allows us, as mentioned, to execute on our clinical development programs. The first bullet here we have the TOPICAL trial is fully prepared, and with that's the POLB 001 CRS prevention trial. We've appointed ACT as the clinical trial executioner, the CRO that will run the trial. We've had fantastic discussions with Johnson & Johnson. They have agreed to supply us with their approved bispecific antibody teclistamab, and they've given that to us at no cost because obviously they're keen to see the reduction in cytokine release syndrome or CRS with teclistamab. We've enrolled now, we've lined up six U.K. cancer centers to be part of this clinical trial. We finished the protocol, and we've gotten MHRA approval, which is very important to allow us to start dosing patients.
Importantly, too, in 2025, we've got Orphan Drug Designation from the U.S. FDA. Again, they recognize the scientific validity of what we are doing, what we are trying, again, reducing CRS. It is linked to, you know, patients who will receive these T-cell engagers, and these are wonder drugs that are now demonstrating cures in in these blood cancer patients such as multiple myeloma. Again, they're, you know, very, very good to get that. There's a lot of additional bonuses that comes with that we'll touch upon later on. Certainly from a partnering standpoint, that actually adds a lot of value to the program when it comes to talking to big pharma company. Intellectual property is very important for this industry. It protects the programs as we get to the market.
It doesn't allow any competitors to invade our space. We did get multiple patents granted last year. Many of you know in the Hypercytokinemia or the severe influenza space, we've been progressing down those roads for many years. Importantly, we got our first patent grant earlier this year in Australia when it comes to the cancer immunotherapy and CRS aspect, so very happy with that. Again, that helps bolster the discussions with pharma companies when they know that the program is protected. We also generated last year positive in vivo data, again demonstrating that we can impact cytokine release syndrome in an in vivo model. Liam will talk later on about a very exciting program we have in collaboration with Johnson & Johnson, with University of Manchester.
That's looked into the broader research into the immunology around cytokine release syndrome. Lastly, making progress on our oral GLP-1 program, which is now expected to start in the second half of this year, due to revised manufacturing lead time. I will highlight that last year we were again very, you know, delighted to fundraise GBP 4.865 million from the market. Tough conditions in the market, I think the investors saw the potential of what Poolbeg is doing, what we can bring to the market. Speaking of this market, we've done some independent analysis where we see that preventing CRS in these cancer immunotherapies is a market opportunity of over $10 billion, and we'll talk about the details around that later on.
When it comes to 2026, this year again we are at, you know, full pace right now. It's a full steam ahead situation. As I say, this first four months or so of this year has been again very productive from a Poolbeg standpoint. I mentioned the patent grant, again, that's in the cancer immunotherapy space, which again adds, you know, validity to the program that we're doing. Again, we're hopeful that there'll be many other opportunities to announce patent grants in other territories as we're going forward. We are, as I said, you know, have a wide, you know, patent application in various territories, they're moving through the processes there. It can be kind of a long, you know, process.
I think we're encouraged by the responses we're receiving from the various PTO organizations and the EPO organizations going through. Exciting this year, we've our LPS challenge study. This is our phase I-B study that again was a very successful study run in the Netherlands. We were able to get peer-reviewed data published in that. This peer review is important because as people looked at the data, looked at the paper itself, and they saw it worthy of publication. We've gotten some very good feedback from that. That springboards us then onto into the CRS prevention study we're talking about. When we see prevention of that inflammatory response in the LPS challenge, we're hopeful that we'll see the similar prevention of the inflammatory response when it comes to cytokine release syndrome that's caused by these cancer immunotherapies.
We were very excited, we had several discussions last year with Dr. Adrian Kilcoyne. He's an expert in the cytokine release syndrome space. He's had many, many interactions with the U.S. FDA around developing clinical trial programs around CRS. He came on board to join our Scientific Advisory Board, and is now a very active member of our development team when it comes to planning what the future holds for CRS clinical trials. I mentioned we got MHRA approval this year as well. Very exciting. Again, it's a rigorous process where they take and review all of our data, clinical and preclinical. As I say, it's a very high bar for any drug to get into human clinical trials, so the MHRA gave us that approval in the past few weeks.
Again, we've announced that in the RNS. That gives us the green light to progress and move into the, you know, the clinical studies that Liam will talk about. Again, we wanna make sure when we're talking to partners, we want to make sure that they're aware that this is a significant market opportunity. T o achieve that end, we've had independent analysis done where we look at the market, you know, the cytokine release syndrome, the incidence that occurs in the various bispecific antibodies and CAR T-cell therapies, these T-cell engagers, the impact it has on the healthcare system, the impact it has on patients, what it costs for the healthcare, you know, systems. Again, we were able to do an in-depth analysis looking at, it's a multi-billion dollar peak U.S. sales potential standalone.
We spoke to three different payers, talking about CRS and our program, they were very enthused that this is a drug that they would happily reimburse, you know, if and when it gets onto the market. They see CRS is a cost drain to them as an insurance company. They'd like to get rid of that. As you know, we're talking about prevention of CRS, so I think it's a very important goal, a very important goal that we want to achieve here and is very well received by these insurance payers, both in, you know, Medicare as well and Medicaid. Again, momentum in partnering has accelerated. As we get closer to the clinic, it's becoming more kind of apparent what we have here is a very exciting program.
As I mentioned, talking to large pharma companies and more mid-size companies that maybe are in the more cancer supportive care area specifically. They're all very excited to see, or to wait and see what this data holds, this clinical data holds as it reads out. As I said, we've got multiple upcoming milestones in the near future. Again, I talk about momentum, I talk about running at full speed. As I say, the POLB 001, the trial site initiation visits have been scheduled, so these are the six sites that we've, you know, are gonna run this trial in the U.K. It's gonna be led by Dr. Emma Searle at The Christie in Manchester, and she's brought some of her hematology, you know, colleagues on board to be part of this clinical trial.
Very excited to get that moving. As I say, the next step then is trial is patient recruitment and dosing. Basically getting the patients on board, these multiple, these relapsed refractory multiple myeloma patients, get them on board and get them dosed and get the clinical trial, the true clinical trial up and running. We always comment that, like, 80%-90% of the work is done in advance of dosing patients, so we've come down the road quite a long way, so are very excited to be at this stage right now. Again, we're looking to have this interim data, the POLB 001 CRS prevention data, in this summer. Again, it's linked to the patient enrollment. These are very short clinical trials Liam will speak to, so we should have data relatively rapidly out here.
The second half of the year we're looking for to commence our oral GLP-1 clinical trial, and I'll talk a little bit about that later on. Fantastic, you know, exciting time for the company. Again, very productive 2025. Very productive first four months of 2026. We're excited to be progressing this forward and again generating that key data, which will be the value inflection point. It'll be de-risking the program and then transactions and collaborations, license agreements will follow from there. Very excited to be in this space, and again, thank you for attending this evening. Liam will present on the POLB 001 program. I'll return in the end and talk about the market opportunity and the oral GLP-1 program, and then we will open up the floor for questions.
Again, thanks for your time right now. Liam, over to you.
Brilliant. Cheers, Jeremy. Just I'm gonna do a brief introduction to POLB 001, but before we jump into the asset itself, I wanna give a little bit of context of where the field has come. Obviously over the last number of decades, a massive amount of progress has been made for cancers. It's not been symmetrical. Some cancers have had significantly more progress than others, but if we look at something like multiple myeloma, it's really been a poster child for where significant progress has been seen. For somebody diagnosed, you know, 23 years ago, 2003, five-year survival, 10-year survival really wasn't that great. 30% five years, 10 years about 20%, and that's 'cause the treatment options really weren't that effective. A lot of these you might be a little bit familiar with, thalidomide, chemotherapy, corticosteroids.
They didn't do a massive amount for all patients. Fast-forward 20 years, the progress has been exponential. If you're diagnosed now, five-year survival rates well over 80% are estimated, 10 years well over 60%. I say estimated because the progress is so quick that the pace of clinical trials is faster than the survival data we have from those clinical trials. At the moment in multiple myeloma, we've obviously, we've had immunotherapies be approved in the last number of years, so CAR T-cell therapies, bispecific antibodies, but also a number of other therapies like antibody-drug conjugates, proteasome inhibitors. It's quite common now for multiple myeloma patients to actually get quadruple therapies as first line or even quintuplet now because the therapies are so effective.
A lot of the projections, so this is a disease with a median, so 50% of people get it age 69 or older, and some of these frontline therapies have median progression-free survival projected to be up around 15 years. Really in myeloma you are at a position where people are discussing functional cures, where really patients will pass away from old age rather than their disease, and that is what we are ultimately trying to achieve for all cancers. What is important about this is that when we get to this stage where multiple effective options exist, patient preference has a significant impact on market uptake of the drug. Patients do not always go for the drug with the best overall survival.
They also consider things like time at home, treatment time, having to travel to hospitals. Some of the tolerability issues can be quite significant for these drugs. The immunotherapies, for instance, have a lot of severe infections that can happen for years afterwards. They all have a very meaningful impact on what drugs patients actually decide to take. For these CAR T-cell therapies and bispecific antibodies, they really are revolutionary. For the CAR T-cell therapies, they're potentially curative in some patients. It's really making sure that they are accessible to all patients. If I zoom in on the bispecific antibodies, these are a breakthrough immunotherapy as well, and they're extending into early lines of therapy.
As I'll show you on some of the later slides, at the moment they have to give micro step-up doses, and it's quite common for patients to be hospitalized for five to 10 days just for these initial doses because of the risk of CRS. They have a significant amount of time in hospital just to get onto these therapies. Obviously they have downstream infection risks as well. A lot of these therapies as well are restricted to specialist cancer centers who have the expertise and the tools to manage these patients. Depends on what country you're coming from, but in some countries this is a very significant obstacle to accessing these therapies. Particularly in the U.S. people talk about things called treatment deserts.
It's where patients can live hundreds of kilometers or miles from their nearest hospital who could administer these therapies, and really is a significant issue for a lot of late-stage patients. CRS, as I mentioned, is a major barrier for some of these immunotherapies to become more widely available, with over 70% of some patients being affected on the immunotherapies. Hospital stays due to the risk of CRS may negatively affect the uptake of these therapies themselves. Just gonna go to the next slide. Just zooming in on that for two seconds. On the left-hand side of this slide as well, we've shown a simple diagram that to have these therapies and how POLB 001 could change the treatment paradigm.
The current standard of care on the left here is typically a patient will come into hospital, they will get their immunotherapy, the immunotherapy will actually activate their immune system. What this induces is cytokine release syndrome, and the risk of cytokine release syndrome, or indeed CRS after the onset, can result in significant hospitalization for these patients. It can persist for days to weeks, and in severe cases it can mean that the patients have to discontinue the immunotherapy, so they have to opt for something else. Obviously they lose time between these different choices, so it's really important that when patients do opt to go onto a therapy that they can continue with it. If we bring in 001, potentially we have something where they can take orally before they have the immunotherapy.
They come into the hospital, they are administered it, rather than the immunotherapy causing activation of the immune system, we still allow activation of the immune system, but it doesn't cause cytokine release syndrome. If we're able to avoid cytokine release syndrome, we can potentially prevent this hospitalization and make this step onto the treatments a lot more manageable and feasible for the patients themselves and for the healthcare system that'll have to deliver it. Just zooming in on POLB 001 a little bit deeper. It's a p38 MAP kinase inhibitor. What this means is that it selectively prevents excessive inflammation without immunosuppression.
Compared to some other drugs that completely block a pathway, actually p38 is kind of like a master inflammation switch, where if you activate p38, you can get global expression of a lot of pro-inflammatory cytokines, which are things that cause CRS. If you don't have p38, actually the production of these falls 80%-90%. The drug itself is an oral agent, again, particularly important where we position this as a prophylaxis. It really needs to be easy for the patients and the hospitals to administrate. We have a strong patent portfolio with potential coverage out to at least 2044. We do have a strong preclinical and clinical data package to date. Favorable safety and tolerability profile, which again, we think is really important as we move into this indication.
We have potential inhibition of IL-6, TNF, and other key inflammatory markers. IL-6 and TNF we mentioned because we know these are main drivers, are significant drivers of cytokine release syndrome itself. As well, Jeremy will go into later in the presentation that there is very significant market opportunity behind this drug, so over $10 billion market opportunity. There isn't anything approved in the preventative setting, and there's a growing number of these drugs that induce CRS, and they're going into earlier lines of therapy. This problem is only becoming much more significant for hospitals across the world. At the moment, these bispecific antibodies will only be delivered in specialist cancer centers until there's a way to make them safer and easier to deliver.
Poolbeg could make that treatment safe enough to extend bispecifics to a much wider treatment population. Just down the bottom of this slide, we have engaged a lot of key opinion leaders on this, who also believe in the program, and that's Gareth Morgan from the U.S. Just to show you some of the data that we've presented before. The last clinical trial that POLB 001 was in was an LPS human challenge trial. This is essentially where you use a pro-inflammatory stimulus, LPS. It's a component to the bacterial cell wall that induces a mild inflammatory response in patients. We can give this to healthy volunteers. It stimulates the immune system very similar to the way the immunotherapy would, and they get something that approximates cytokine release syndrome.
It's an incredibly strong model for us to test the efficacy of POLB 001 in. What we also saw in that trial was that POLB actually had an excellent safety and tolerability profile as we expected. We were able to confirm potent target inhibition, that's of p38 MAP kinase. We had a clear dose-response relationship observed, which is really important from a drug development perspective. We also, from a CRS perspective, had a major reduction of key inflammatory cytokines. On this slide, we're showing IL-6 and IL-8. Just briefly, this LPS challenge trial was placebo-controlled and had three different doses of POLB 001. The gray line, as indicated underneath, is the placebo. The green line is 30 mg of POLB 001 given twice daily.
The blue line, again twice daily, 70 mg, and the red line is the highest dose of 150 mg POLB 001 given twice daily. What we can see in the graphs is that actually if you just give placebo with the LPS challenge, you see this spike of IL-6 and as well on the right-hand side, IL-8. Actually, as we introduce increasing concentrations of POLB 001, we see a suppression of these increases, which is exactly what we hypothesized it will do in cytokine release syndrome. The lowest dose produced a small decrease, but the two upper doses, actually you can see they almost overlap, and this is probably maximal inhibition through p38, where the inhibition is in the region of 85%-95%, which is really promising as we move forward into further trials.
We have the potential to effectively prevent cytokine release syndrome while preserving key immune system functionality. I think that's a key element that we always have from clinicians in that a lot of the existing drugs that completely block a pathway, they have their downsides. They often induce cytopenias or other adverse events, which really isn't preferable in an indication like this. As Jeremy mentioned, we are really excited at the moment. We recently announced that we have all the approvals in place to start dosing patients, and the trial is moving forward at speed. POLB 001 first in-patient TOPICAL trial, it's being conducted in the U.K. It's a trial of prevention of immune cytokine adverse events in myeloma. It's being led by Dr. Emma Searle, who's a leading hematologist based in The Christie in Manchester .
It's being run by Accelerating Clinical Trials. Again, we've previously spoken about this to the markets, that this is a specialist blood cancer organization who are equipped to run trials in the U.K. in these clinical trial centers that we're tapping into to recruit these patients. It's a really strong team who know the sites, who know the investigators, who are equipped to really accelerate this trial the way we need to. The objective of the trial is to investigate the safety of POLB 001 and also the efficacy, in particular, its ability to reduce the incidence of CRS in patients receiving approved bispecific antibody teclistamab. Teclistamab being the immunotherapy that induces cytokine release syndrome. We'll have approximately 30 patients, and we will be recruiting a patient population of relapsed refractory multiple myeloma patients, receiving this antibody.
We are really excited. All of the leading sites in the U.K. are really participating on this trial, so it's being led by Dr. Emma Searle, as I mentioned, at The Christie. Also, we have UCLH, we have The Royal Marsden, Birmingham, University Hospitals of North Midlands , Royal Stoke, and Edinburgh. We have an exceptionally strong team that we are really optimistic that we can complete this trial quickly. Just a little bit more detail about the actual trial itself. This is the design of the trial. On the top left, this schematic is showing the trial design. I mentioned with the bispecific antibodies earlier in the presentation that they get things called step-up or microdoses. If you were to give a full dose of these bispecific antibodies, what would happen is you'd activate your T-cells.
You get autoimmune cells activated, and you get overwhelming cytokine release syndrome, which could potentially kill patients. The only way at the moment to deliver them safely is to give these microdoses. The microdoses are there to give the body a small exposure to cytokines, the body needs to get used to seeing these cytokines without inducing severe CRS. Once the body has seen the cytokines once or twice, actually they can go forward with normal dosing. These step-up doses are critical purely to mitigate the risk of cytokine release syndrome. These typically happen over a five to eight-day period. During this period, patients are typically hospitalized, depending on the cancer center that they're in.
What we're trying to do in the trial is we are gonna pre-dose POLB 001, so prevention, from before that first step-up dose until after the first dose. Here in the schematic, that would be indicated on day 147. We'd be dosing, and actually 96%-100% of all the cytokine release syndrome happens in that period, and that's the period that's really hard for clinicians to actually manage in these patients at the moment and is mandating the hospitalization. Twice daily oral dosing with POLB 001. It's a single-arm trial, meaning no placebo, but we're really trying to get the evidence of efficacy as quickly as possible, we want to give everybody our drug. 30 patients, as I mentioned.
Teclistamab really promisingly is being provided by J&J, it's an open label trial in that all the patients know that they're getting POLB 001. We're really excited that we have fantastic investigators. We have the collaboration with J&J, and we have the right team with ACT to really deliver this trial quickly. The protocol has been finalized. All the regulatory approvals are in place, site initiation visits are scheduled, patient recruitment and dosing to commence shortly, we hope to be able to give further updates as we go. The key endpoints, as I mentioned, instance of CRS, severity of CRS, confirmation of the safety and pharmacokinetics. That's more just to make sure that the drug, as I mentioned, is exposed to patients at the right level. Obviously CRS management and tocilizumab usage.
CRS management, what we mean is the duration of hospitalization. Everything to do with the current challenges of managing CRS will be managed in or measured in this trial. We have great team of investigators. We have J&J. That's because there is a massive amount of excitement about this program. If we can find a drug that really solves the CRS problem, I think a lot of people realize the potential of it. There's also been a GBP 3.4 million grant to the University of Manchester and The Christie. The program is called RISE. RISE is about reducing immune stress from excessive cytokine release with advanced therapies. It's being led by the University of Manchester. The NHS Christie Trust, where we're the lead site on the TOPICAL trial, is the clinical lead.
We are the lead business partner because we are experts in cytokine release syndrome at this stage, and J&J are an industry partner providing teclistamab for it as well. It's been led by a fantastic cell therapist who delivers solid cancer cell therapies to patients, Dr. Jonathan Lim. He's a clinical senior lecturer and honorary consultant medical oncologist at The Christie and the University of Manchester. We really have a multidisciplinary team. The whole idea of this grant is actually to research things of this is an on-target effect of immunotherapy. There's nothing surprising that these immunotherapies induce cytokine release syndrome. It's predictable. We know the mechanism, we know the triggers, we know how to potentially prevent it. That's a great opportunity to learn more, to really research this in the clinic.
POLB 001 is gonna be a key element of the overall research grant for preclinical and clinical, but the TOPICAL trial itself will be a central focus of it. We'll be generating additional clinical evidence as part of this on CRS from bispecific antibodies and CAR T-cell therapies, 'cause as Jeremy will have mentioned before, there is a major commercial opportunity for the prevention of CRS related to CAR T-cell therapies as well, not just bispecific antibodies. This is real significant recognition of the unmet need in CRS, and it's something that we're really excited for. We do expect if there's positive results from this trial, that the interest in the program is only gonna grow. We're really excited moving forward. With that, I will hand back to Jeremy.
That's wonderful, Liam. Thank you for that. I think it's a very nice segue as we do talk about the market and market opportunities. As I mentioned at the outset, we've done a lot of work, you know, trying to assess what the global CRS market looks like. We've taken on board some consultants to get that independent perspective, and I'd say it's a very important acknowledgement when it comes to the partnering and partnerships, kind of what the value we're bringing to the table is here. As I say, we're looking from our analysis about a $10 billion market opportunity, and I'll break that down as to, you know, how we came to that number briefly.
I just want to flag that, you know, for both bi-specifics and CAR-Ts, these are quite, you know, expensive drugs in their own right, but as Liam mentioned, we believe that these are life-saving drugs. You know, sometimes there's cures observed. For CAR-T, now it's more of a laborious approach where you take a patient's T-cells out, you re-engineer them, and you introduce them back in, and they're bringing the immune system closer to the tumor, and these are quite expensive, but as I said, these are reimbursed in the U.S. by the American insurance companies. When you look at bispecific antibodies, it's slightly less, but it's still a significant cost to the insurance companies.
Now, what we've did with this analysis is that we narrowed in on two different tumor types, two different blood tumor types, diffuse large B-cell lymphoma and multiple myeloma. If you look at the markets in the U.S. and the European 5, with these, the incidence of these diseases, they total to about 500,000 patients between now and between 2023 and 2030. The market is kind of large. Market is growing. What we did when we looked at, like, what would we charge, what would we, you know, charge the, you know, the insurance companies for POLB 001, we looked at a very interesting and probably very appropriate comparator. This is a drug, Neulasta, which is used to treat neutropenia.
When patients get, you know, chemotherapy as an example, they get, you know, they're obviously trying to reduce their tumor burden, but it also reduces a lot of their kind of white blood cells. This Neulasta brings those back up. You know, when that was launched many years ago, it was introduced in at about $18,000 per cycle. We kind of took that realm that POLB 001 could be in that. If you take, you know, roughly $20,000 by the 500,000 patients, you're looking at a $10 billion market opportunity just for these two tumor types and for these two markets, the U.S. and the EU five. Obviously we could go broader than that.
We've mentioned a few times that CAR T-cell therapies, bispecifics are now moving more into solid tumors, so there's an opportunity there where CRS is also observed. Interestingly, looking into autoimmune diseases, but that's a story for another night. Yep. As I say, we're looking to prevent CRS from happening in the first place, and I think that, you know, if we this is where we got J&J's attention, for example, and I'll talk a little bit later on about our partnering initiatives. They got the attention. To prevent is obviously better than cure. It's an old statement that's well worn.
They see that, if we can prevent CRS then they can get their drug, their bispecific antibody, you know, as an example, into community hospitals, getting it away from these dedicated cancer centers because you need people on hand to manage the CRS, but if the CRS isn't there, then we're in a fantastic situation. As I say, you know, it is a cost to insurance companies, cost to the healthcare system. We talk about grade 3 CRS actually costing greater than, you know, $70,000 as a, as a management, as treatment. Of course, let's not forget the patients who have to go through this issue. There's many, you know, many things at play here.
More recently, this is a lot, the most recent piece of work that we did is that was very enlightening, where it's one thing about understanding the patient population, you know, these multiple myeloma, diffuse large B-cell lymphoma, but we needed to talk to ultimately the payers. These are insurance company. We looked at the U.S. because that's the large and major market, and we partnered with IQVIA . They had, they held with three different payers that cover 75 million lives in the U.S. They introduced them to POLB 001, the target product profile, what it is, what it does, what it's intended to do, and asked about payments. "What would you be willing to pay for these drugs?" I think there's a, you know. It's quite a long quote here.
I won't go through it all. It was very clear that there's a willingness to pay for a commercially you know, meaningful price for POLB 001 because they know the offsets. They know that patients will spend less time in hospital. Overall their insurance burden is less. It's obviously beneficial for the patients. It takes the pressure off the healthcare system as well. Maybe it spreads it a little bit thinner. Instead of these, you know, patients being in these dedicated cancer clinics, they can go kind of outside in their community hospitals. That's really where people are, you know, are attempting to go. You know, have the treatments on your doorstep.
I think from a, you know, psychological standpoint, you know, these patients are already going through cancer treatment, but if they can get it closer, you know, their treatments closer to home, all the better off because they'll have family support networks around. As they say, you know, they see that POLB 001 is a compelling CRS solution with significant market potential. That was obviously music to our ears when we, you know, we kind of believed in the program, but obviously, you know, to see it in black and white as the payers would be willing to pay was very exciting and very gratifying, I must say. Again, from the market opportunity, and I've outlined this already, 500,000 patients.
You know, there is that bottleneck where they can't get access to the drug rapidly because beds are being taken up in the CAR T-cell therapy setting. As I say, if you can remove CRS, then you can open up this. We've talked, as Liam said, many key opinion leaders, thought leaders in the space, multiple myeloma docs, and they're all echoing the fact that if you can reduce or eliminate CRS, a whole load of infrastructure falls away. Their lives are easier, the patients' lives are easier. As I say, we now we're confident that the insurance companies are willing to pay for the drug as it goes forward. Again, very, very exciting time for the company. I see a question coming in about partnering, maybe I'll address that right now.
With my background, I'm a scientist by training, but in the industry, I spent a lot of time on business development in the partnering setting. We spent the last, in particular, the last nine to 12 months really focusing, ramping up the partnering as we're getting closer to the clinic that, laying the groundwork, talking to the big pharma companies, as I said, the mid-size companies about 001, what we do. We've caught a lot of attention. I think that happens, and it's not by coincidence that it's closer to the clinic because then there'll be a data readout, and as I mentioned, a de-risking readout. Again, people appreciate that there are more and more cancer immunotherapies coming to the market, and CRS is still an issue with them.
You know, pharma companies are looking to fill their own pipeline as well with new programs coming through. That's all linked to the patent cliff. I mean, it's been cleared as GBP 300 billion in annual prescription drug revenue will fall off because of patent cliffs, and they'll be substituted by generics. Pharma need to kind of boost their, you know, their bottom lines. They need to get more drugs into their pipeline. I think when we talk to the smaller companies and show that, you know, we can have POLB 001 in combination with any and all CAR T or any and all bispecific, they see this as a significant market opportunity. Over the last, as I mentioned, nine to 12 months, we've attended a lot of conferences.
JP Morgan in San Francisco this year was particularly productive. Again, face-to-face meetings with decision-makers at pharma companies. We attended BIO-Europe, LSX as well. These are, you know, again, lots of partnering meetings talking about POLB 001. Just last weekend, Liam and our clinical colleague, Mina, attended the British Society for Haematology, meeting directly with our investigators, again, building momentum on that front. In the near-term future, we're attending the European Hematology Association meeting in Stockholm and then BIO International Convention in San Diego. Again, that's where all the pharma descend on a city. Obviously, the EHA is hematology specific, so we'll be talking directly to the, you know, the, the decision-makers in the, you know, the hematology or myeloma spaces. Then BIO is on the business development front.
We've got meetings set up there as well. Again, they're very excited to see the clinical data as it comes through. I think, obviously, you know, from our, you know, past successes, you could say, you know, great discussions with Johnson & Johnson providing their bispecific antibody free of charge. You know, they want to see CRS reduced, and we're hopeful we'll be able to do that with this TOPICAL trial we've discussed. As I say, the mid-size pharmas are interesting because, you know, they've got smaller pipelines, but they see this cancer supportive care element that, you know, they could obviously get this drug to market relatively quickly. We can talk separately on that, these are very short-term trials because we're only looking at that initial immune or inflammatory response.
As I say, lots of really productive discussions there. You know, we have a virtual data room that's populated and open, and we've got people in the data room kind of exploring the, you know, say the preclinical and clinical data we have. It's all a case of once we have that clinical data in hand, then we kind of trigger those negotiations around, you know, a deal and a transaction to generate revenue from there. You know, again, I'll reiterate from a POLB 001 standpoint, we're very excited to, you know, with the progress we've made. Obviously, in the not-too-distant future, there'll be very exciting milestones to report. I think we've gone over a little bit on time, so I will just kind of go briefly through the GLP-1 program.
You know, people are very familiar with GLP-1, initially diabetes drug, but now very applicable to obesity. These are primarily given by injection, and there's a big need or an unmet need to have an oral option for that. We've partnered with AnaBio, here the, down in Cork. They've got products on the market that use this encapsulation technology. It's more in the food science space, but we're using this technology to encapsulate GLP-1, protect it from the stomach acids. When there's a change of pH, that is released in the small intestine, which is the site of action here. Huge market, huge opportunity. In our partnering discussions we've had, you know, at the partnering conferences, you know, it's, you know, people have reached out to discuss this program.
As we're standing now, we've got a clinical trial that's designed, ready to execute. We are moving into that kind of manufacturing phase, the timelines for manufacturing, you know, that's going on. Again, it's the manufacturing has been demonstrated before. We've done a lot of the validation studies and assays, et cetera. Now it's just to get that GLP-1 material ready for the clinical trial. It'll be run by a Professor Carel le Roux up in Ulster University. He's very well recognized in the metabolic disease space. It's a very straightforward clinical trial in that it's 20 volunteers. We're looking at safety and tolerability and pharmacokinetics, getting the drug on board. We'll test that from, you know, glucose tolerance test, very simple study where we want to see the drug having effect on metabolism, essentially in these volunteers.
Designed to get the rapid readout and, you know, very excited to see this program move forward as well. There's a good deal of interest in that from a business development standpoint. I'll wrap up in this slide. I certainly want to leave time for questions. I see there are a few coming in. Again, a reminder, a very experienced team, we are executing right now. I think we've done a very, I'm very proud of the team. We've done a terrific job the last 12 months to move 001, you know, to be here. We are on the precipice of dosing patients. That's very exciting. These are very high-value programs. I think we've found the right, the right disease for POLB 001 to go after, this acute inflammatory condition.
Importantly, with the fundraise last year, we've got our financial runway into 2027. That gives us time and scope to negotiate the best deal for Poolbeg once we have the data in hand. As I said, the partnering discussions have been, you know, on many levels, as I say, large and small companies. We've got many discussions going on in parallel, you know, data room open, reviewing, you know, the preexisting data. As I say, people are waiting for this clinical data to read out, because that's the value inflection point. That's the de-risking episode where you're having data in this TOPICAL clinical trial in multiple myeloma patients, relapsed refractory multiple myeloma patients. This will be the key trigger for Poolbeg. Again, thank you all for your time, again, this afternoon, this late afternoon.
What we'll do now is that we'll switch to some of the questions that came in, again, appreciate your time on that. All right, we'll jump straight in. Oliver has a question. "When are the CRS trials due to be completed? Summer 2026, can you pin this down June, July, or August? Although summer in the U.K. is realistically a 2-week period." Nice one. Good bit of levity there. "Once completed, will it be go- or no go-decision, or is there a potential for a phased decision tree solution? If not, the results you're looking for." Listen, that's a really good question. We could spend a while kind of talking about that. I think we mentioned earlier on, like, one of our ambitions was to get the data as quickly as possible.
That goes without question, and this is why with ACT, you know, who are gonna run the clinical trials, and with EMA, we're zoning in on six clinical trial sites. Now we're exploring options for more. What comes from that then is kind of rapid enrollment. That's ultimately the goal here, get more patients, you know, on board quickly, get more drug on board quickly. Liam and Mina and the team have done a terrific job of kind of lining up that kind of analysis that comes after that. You know, it's well understood that teclistamab drives CRS in greater than 70% of patients, but we're gonna analyze that immune and inflammatory response at a molecular level.
These are looking at all of the cytokines that are there and the signs and symptoms, but at the kind of blood and molecular level looking at that. It depends is probably the answer, but, you know, it is once we have that certain number of patients going through where, you know, we can kind of interpret the data. We've done statistics, et cetera, that up to 30, you know, patients would be the full trial. As mentioned previously, this is an open label trial, so we'll have access to the data pretty rapidly on that for each individual patient. It's not blinded, so we know that each patient will get the drug.
It's a really, you know, good question, but as I say, we're planning and what we've built so far is gonna get rapid enrollment to say six clinical trial sites, maybe more. The question around decision trees, I mean, it's, you know, obviously we gotta wait to see what the data is, but I think if the data is strong and the way we've built up the business development, you know, partnership aspects, I think there'll be multiple suitors here. I think there'll be strong interest, you know, if the data's positive because it can be applied to multiple pharma companies, and I mentioned the cancer supportive care area. As I say, we'll be running full steam on those negotiations when it comes to you know, one of the interesting questions here is kind of the deal type.
You know, we feel that on the one hand, you know, with the big pharma may come in and just take over and run the trial themselves. There could be opportunity to, you know, partner with a smaller company where we would kind of help and assist, kind of run the clinical trial, 'cause it is our baby in one sense, but it is our expertise in what we're doing. You're right. There'll be decision trees and discussion, negotiations with multiple parties. We'll figure that out. Oliver had a second question here. Is 30 people enough for a trial for a commercial outcome?" Again, maybe Liam, you can talk to that just around the stats, discussions that we've had around, you know, how we ended up with 30.
Really happy to, Jeremy. 30 patients is essentially more than enough for our purposes right now. About 70% of these patients are gonna have CRS, there's gonna be a very strong indication of the level of efficacy. The priority from a clinical development perspective is to really get into your placebo control trials as early as possible once you have an idea of the effect size. We're gonna see the effect in grade one and grade two and also the other elements of CRS management like hospitalization that will give us a really good indication of how to design later stage trials. 30 patients for this purpose is actually ample.
Cool. Thanks for that. You know, these are kind of numbers that are not plucked out of the air. You know, there's been kind of deep analysis into what are the right numbers. Credit to Liam and the team for their discussions with, you know, qualified statisticians, you know, to come up with those numbers. All right. Another question here. "Could we see a deal after interim data?" I mean, again, it's a good question. I mean, I've Maybe I've already answered it. When it comes down to, you know, what that data looks like, and as I say, rapid enrollment, we'll get an early read into what the data look like.
If it's, you know, if we're seeing an impressive suppression of that inflammatory response, that CRS, then I think, you know, for certain companies that might be enough to transact. You know, for others maybe, you know. I've been through this in my past, you know, where there's always that next experiment or the next data point or the next data set. You know, some companies are maybe a little more conservative when it comes to decision-making, and maybe I'm alluding to the fact these are more the bigger guys who have to, you know, work the chain of command. I do think that, you know, as I say, having interim data will be a key point, and if it's positive I think there'll be strong interest. Richard had a question.
Your projected timescale towards commercialization." Commercialization is, it's always tricky in this industry. I mean, getting on the market is one question. That'll be down to the partner and we're driving that forward. Can say we're experts in CRS. We're experts in running these, you know, initial clinical trials. The larger clinical trials, you know, we can do ourselves, but having a partner on board to kind of fund that would be critical. You know, there are. That'll be kind of, you know, a few years down the line. As I say, once it's launched on the market, you know, then it'll be we feel it'll be, you know, broadly applied to any and all bispecific CAR Ts. You know, timeline, that'll be driven by the partner.
I say that we don't see ourselves as obviously driving that forward ourselves in isolation. Potentially through a partnership. Another question. "If data lands well this summer, what does success look like?" That's a really good question. I mean, in my mind, and this goes back to my kind of business development training, I mean, we're looking at a nice substantial transaction. We're looking at a partner to come on board with capabilities, with funding, with funds, you know. What happens in the industry when it comes to these licensing transactions, whether, you know, as I say, maybe people want to buy the program, buy the company, just license the program, you know, that'll be, you know, for another time and other discussions.
I think that what we're seeing what success looks like is certainly, you know, a juicy upfront payment when it comes to the work that we've put in, 'cause we've done a lot of work. We've de-risked the program. It's a large market. It's an attractive market. We've filed important intellectual property, so it will be protected. You know, we, you know, we see significant value for our contributions there. As I say, the structure after that is down to the individual company we'll speak with, you know, or decide to collaborate with. Whether it's, as I say, just passing the baby across that a large pharma could develop or co-develop ourselves. That's all. We believe with strong data that Poolbeg will have the leverage for those negotiations because the interest is so high.
Appreciate that. I think we've time for one more question. "How much interest are you seeing in the oral GLP-1 for potential partners?" Again, appreciate the question. Good question. In our most recent, you know, partnering conference attendances at BIO-Europe, for example, we had companies reaching out to us. I was always, you know, pleasantly surprised. You know, some of them are kind of in Asia, some of them in Europe. You know, some of them already had existing metabolic disease programs, and they were looking to kind of branch out, add to their pipeline. I think, you know, I don't wanna be flippant and talk about no-brainer. If you get GLP-1 that can be delivered orally, it opens up a whole host of markets and market opportunities.
It's a huge and growing market, you know, moving away from injectables, the industry wants to go there, the patients want to go there. If we can demonstrate that clinical proof of concept in the trial that I outlined with Carel le Roux, I think there'll be strong interest then in partnering, you know, the program out. Again, revenue from, you know, upfront payments, et cetera. Appreciate that. I think we've ran s lightly over time. Appreciate people's patience. But yeah, we can wrap up now. Just again, thank you again for attending.
Fantastic. Thanks indeed for updating investors today. Can I please ask investors not to close this session as you're automatically redirected to provide your feedback.