Operator: Good afternoon, and welcome to the Arecor Therapeutics PLC investor presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged and can be submitted at any time via the Q&A tab situated on the right-hand corner of your screen. Simply type in your questions and press send.
Operator: The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I would like to submit the following poll, and now I would like to hand you over to the management team. Sarah, good afternoon.
Sarah Howell: Good afternoon. Thank you. Good afternoon, everybody. It is a pleasure to be here. Thank you for taking the time to join us today. My name is Dr. Sarah Howell. I am the CEO of Arecor Therapeutics, and I am joined by David Ellam, our CFO. We will be talking through today our H1 results for financial year 2026 and the post-period fundraise. As you know, but just as a recap for anybody new joining us today, Arecor is a clinical-stage biotech company.
Sarah Howell: We are very much focused on developing superior therapeutics that can reduce treatment burden and improve outcomes for people living with diabetes, obesity, and other cardiometabolic diseases. Our focus remains very much on our two core product areas within diabetes and the oral delivery of peptides. In both of these areas, we are addressing or looking to address high unmet patient need in large multi-billion dollar markets here.
Sarah Howell: Within the diabetes area, we have best-in-class, concentrated, ultra-rapid-acting insulins. Our talk today is a little bit of a recap for those that know us well and for those joining us for the first time today, why we are developing these insulins, what is the unmet patient need, and then subsequently the commercial opportunity that comes with that. Essentially here, we have designed these insulins to enable that next generation of automated insulin delivery systems.
Sarah Howell: These are longer-wear, much smaller systems that can be used in a fully automated mode. Again, we will explain what that means. We have entered into, and we are pleased to announce with the recent results, partnering discussions with multiple insulin pump companies that are now at term sheet stage, and we can talk about that a little bit more.
Sarah Howell: We continue to work very positively with Sequel Med Tech around AT278, so that is our 5 times concentrated ultra-rapid acting insulin towards phase II, and also in very positive negotiations there with those next agreements.
Sarah Howell: Within the obesity space, this is very much around the oral delivery of a GLP-1, so this is a GLP-1 receptor agonist here, and we are very much focused again on developing that preclinical data package where we are looking to improve bioavailability of GLP-1, which would be highly translatable to other peptides should that be successful. Of course, I am sure you all have seen our post-period end financing.
Sarah Howell: We have raised GBP 5.13 million gross proceeds under this placing, and essentially that was around strengthening the balance sheet. We have cash through to the end of 2027 now, and that is strengthening for those expanded partnership negotiations with multiple insulin pump companies, and also enables us to commit to those key and critical path activities, development activities, essentially to generate all data that we require to file an investigational new drug application for our phase II clinical study.
Sarah Howell: That would include manufacturing that clinical trials material so that we can move at pace into that clinical study alongside our insulin pump partners. I am now going to hand over to David just to talk through the H1 financials.
David Ellam: Thank you, Sarah. H1 2026 key financials, so just some of the key elements of that. Revenues, GBP 0.2 million, reflecting both the focus on the insulin and also the 25 September sale of the royalty rights to Ligand. Last year, that brought in over GBP 5 million of non-diluted funding, and then so far this year, by September, we brought in GBP 0.7 million of non-diluted funding.
David Ellam: In case you are wondering, that does not appear in the income for this year because the GBP 0.7 million was accounted within the gain or loss disposal in the prior year. R&D expense has increased from GBP 1.3 million to GBP 1.9 million, reflecting our increased spend on the insulin, especially on AT278. The G&A expense decreased from GBP 1.7 million to GBP 1.5 million in the half as we look to actively reduce certain corporate costs.
David Ellam: The guidance is that the board expects revenue for full year of GBP 0.3 million and a loss after tax of GBP 5.5 million, and also the ending cash at the end of the year will be about GBP 5.7 million. As we saw on the previous slide, the fundraise lengthens the cash runway to December 2027, allows us to strengthen the balance sheet for all the partnering negotiations, and then keeps us on the critical path for all of the phase II, R&D-related, and clinical manufacturing-related activities.
Sarah Howell: Thank you, David. I am now going to move into talking around our insulin portfolio, which is the clear focus. What we have been able to demonstrate is with our technology, where we are taking existing insulin, we have developed novel formulations of those insulins to enhance their profile. Essentially here, we are looking at accelerating the absorption of insulin, so very fast-acting insulin, even at very high concentrations here.
Sarah Howell: We have demonstrated clinically here from concentrations from 100 units per mL, which is our AT247 candidate, right through to 500 units per mL, which is AT278, that we have been able to clinically demonstrate superior pharmacokinetic and pharmacodynamic profiles compared to those very best insulins that are available today from Eli Lilly and Novo Nordisk. This is essentially, we have accelerated that absorption of insulin, and we get an improved glucose-lowering profile because of that here.
Sarah Howell: The reason that we are doing this is there is very much a need in automated insulin delivery systems. Just a quick recap, this is where a patient will wear a continuous blood glucose monitor, which measures their blood glucose at any point in time. This is fed to an algorithm which calculates, based on that reading, how much insulin is needed to keep that individual inside their target blood glucose range, which is automatically delivered via a pump.
Sarah Howell: These are very much becoming standard of care now, these AID systems. In fact, both across the US, the ADA, and Europe, the EASD, now have updated their guidance actually this year within 2026 to recommend that AID is the preferred treatment option for people living with diabetes, both type 1 and insulin-intensive therapy type 2 diabetics.
Sarah Howell: There is very much a drive to move people across to AID systems, and the reason for that is that we see better outcomes for people living with diabetes, better blood glucose control if they are using an AID system. Of course, there are still some challenges that remain within those systems, and I will talk about those now and why our insulins are best placed, and in fact, the only insulins that can meet those challenges and meet the unmet patient need and help people transition across to these AID systems.
Sarah Howell: Essentially, when we look at insulin, the challenge here is as you concentrate up insulin, it slows down its absorption profile, so it is slower to absorb into the bloodstream and be available for blood glucose lowering. We have seen that, and we have demonstrated that clinically in head-to-head studies as well.
Sarah Howell: We have overcome this challenge, and we have overcome that from any concentration from 100 units per mL over to 500 units per mL. So very much looking at our insulin portfolio here as a platform approach. We have bracketed these concentrations, so essentially, we can demonstrate this superiority at any concentration between 100 units per mL and 500 units per mL.
Sarah Howell: You will have noted, certainly within our results and within the presentation today, we have incorporated an AT290 into our portfolio and into our product pipeline here, which is a two times concentrated insulin, and it is essentially two times the concentration of AT247, and we can talk about that a little bit more. We talked about the fact that AID systems are better for patients, they receive better outcomes, but we still see relatively no adoption here.
Sarah Howell: In the US, where the adoption is greatest, there is still only around 40% of people with type 1 diabetes and only 5% of people with type 2 diabetes are using these AID systems. The simple fact here is why are more people not using these AID systems is that there is still too much work to use.
Sarah Howell: There is too much interface that is required and decisions that are needed to be made via those patients and by the patients, and too much interaction with the AID system. So what patients are looking for is they want pumps that they can wear for longer. This may sound relatively straightforward here, but this is around when you are using these pumps and applying these pumps, the standard of care at the moment is that they wear them for three days.
Sarah Howell: That means at the end of three days, you have to refill your insulin cartridge, you are removing pumps, you are either disposing of those if they are disposable pumps, refilling another pump with insulin, applying that pump, changing infusion sites. This is something that has to be done every three days.
Sarah Howell: If you could extend that to seven days or longer, that obviously reduces the amount of times that the patient has to go through these processes and steps, and this is alongside everything else that they need to do to manage their disease. They also want these pumps to be smaller. They are a very visible indicator that you are living with a chronic disease and you are wearing them on your skin. The move is very much towards wearable patch pumps.
Sarah Howell: Here, that is what the patients are looking for, it is where the industry is going, and everybody wants these to be as small as possible. So if you want to wear pumps for longer and you want them to be very small, it means that you have to get more insulin on board in a smaller capacity, so you need concentrated insulin.
Sarah Howell: Then we come to the speed. We know that if you do not do anything special here, which is what Arecor has done, as you concentrate up that insulin, you are going to lose the speed and you are going to compromise it on its blood glucose lowering profile. Again, that is what we have overcome here. Because we have the fastest-acting insulin in development, even at those high concentrations, it means that we can respond more rapidly in real time to these fluctuations in blood glucose.
Sarah Howell: Why this is so significant, again, if we think about burden for patients, is here, as they are wearing these systems today, they are in what is called hybrid closed-loop mode. This means at meal times, where we see this swift rise in blood glucose, the individual needs to count their carbohydrates and estimate their carbohydrates.
Sarah Howell: Nobody does that accurately. It is quite impossible. They then need to tell the system that they are going to eat a meal and how many carbs they are going to have with that meal. This is all down to the speed of insulin, because insulin today is just simply not fast enough to react in real time to those swift rises in blood glucose.
Sarah Howell: If you have a much faster-acting insulin, this gives us the potential to stop having to count carbs, stop having to tell the system that you are eating a meal. This is ultimately the holy grail for people living with diabetes on AID systems, to move across to what we call a fully closed-loop system. So fully automated and no inputs and interactions required around those very important mealtimes.
Sarah Howell: A combination of a full closed-loop system plus longer wear and much smaller pumps significantly lowers the burden for patients, and we can do this whilst maintaining and improving outcomes because of the speed of our insulin. If we look across what is available today, there are no concentrated rapid or ultra-rapid-acting insulins available for use in AID systems.
Sarah Howell: The insulins that are approved today for use in these systems are 100 units per mL, so that is a standard concentration of insulin. With those, obviously, you cannot enable that longer wear, smaller pumps, and also, we have this superiority around speed. Arecor's platform is very much focused on that next generation of insulins that are more concentrated and rapid-acting, and we have both AT290, so that is a two times concentrated insulin that enables us to unlock the standard of care of three-day wear for people with Type 2 diabetes.
Sarah Howell: The average person with Type 2 diabetes in the US requires around 100 units of insulin a day, and the very largest pumps with the largest insulin cartridge can only hold 300 units of this standard 100 unit per mL concentration insulin.
Sarah Howell: It essentially means that the majority of the Type 2 patient population cannot make it even to three-day wear, never mind to an extended seven-day wear. It also extends out the addressable patient population who can achieve seven-day wear, so taking more of those Type 1 diabetics to seven-day wear, and of course enables us that leap into fully closed-loop AID systems.
Sarah Howell: If we look at AT278, what that brings to the table here is not only does it further expand the addressable patient population that can get to seven-day wear, plus it also enables that future miniaturization of these insulin patch pumps, which is very much where the insulin pump companies are innovating and looking at bringing their next generation insulin pumps to market, but they simply will not be feasible and be practical for use without a highly concentrated insulin.
Sarah Howell: Just to show that in some numbers, I know you have seen these heat maps before, but I think it is a useful way of demonstrating this. If we look again, this is US-based data, so this is using the very largest insulin pump cartridge in the AID systems today, so this 3 mL cartridge.
Sarah Howell: You can see here for Type 2 diabetics with standard insulins, 100 unit per mL that are available commercially to them today and approved for use, nearly 50% of Type 2s cannot make it to three-day wear, so they are simply not using AID systems and simply not gaining the benefit of improved control that we see with them, and almost all of them cannot make it to seven-day wear.
Sarah Howell: And you can see that we can get more and more of that patient population to this 3 and 7-day wear as we go through our U-200 and U-500 concentrated insulin. But it is not just a type 2 problem. We see this with type 1s as well. If we look at going towards that 7-day wear, over 50% of the type 1 patient population cannot get to 7-day wear.
Sarah Howell: If we further miniaturize these pumps, make these insulin cartridges much smaller, of course, this further exacerbates this issue. I think what we have really seen over the last, certainly over the last 18 months, 2 years, is a significant shift in innovation from the insulin pump companies. It is the insulin pump companies that are developing all of this technology and hardware, if you like, for AID.
Sarah Howell: They are all focused really on this opening up the patient population, making their systems lower burden and more accessible for both type 1s, but also increasingly importantly for the type 2 patient population. So they are focused on getting approval for the type 2 indication, and that is across the majority of the commercial pump companies now have type 2s on their label.
Sarah Howell: They are looking at higher insulin capacity, longer wear. Two of the 5 pumps now are approved for 7-day wear. The challenge is, of course, getting enough insulin on board to really transition patients across to this improved 7-day wear. They are very much looking at improving their form factors. We have one patch pump on the market today from Insulet. 27.
Sarah Howell: We really are entering an era of innovation from the insulin pump companies, and we can see here there is very much a need for a highly concentrated ultra-rapid-acting insulin for them to achieve their ambitions and to deliver this next generation of systems to the patient population.
Sarah Howell: If you look at that in terms of the size of this patient population and unmet need and what that translates over to in terms of commercial opportunity here, again, we are looking at the US. There is clearly an opportunity and an upside opportunity outside of the US as well. We have around 4 million people in the US that are candidates for an AID system. That is all of type 1s and intensive insulin therapy type 2s as well.
Sarah Howell: Of those, we see around 1 million of these are people with diabetes that require more than 100 units a day, so they cannot get to this 3-day wear time, and they are simply not using AID systems. Of that 4 million, around 1 million are currently using these AID systems today, but they clearly want longer wear, smaller pumps, and full closed loop. Again, they are looking at lowering the burdens but improving their outcomes.
Sarah Howell: If we take that 2 million patient population, which we see as those who have the highest unmet need for a highly concentrated rapid-acting insulin such as ours, that translates to an insulin revenue opportunity of around $3 billion there. Of course, there is additional upside as we see these insulin pumps further miniaturize, that more and more of this patient population will require a highly concentrated rapid-acting insulin.
Sarah Howell: You may ask the question, but why would the insulin pump companies partner with Arecor? What is motivating them to get to term sheet stage with us to look to further develop and bring an Arecor insulin AID system to market? If we really look at the opportunity within AID, it is clearly growing.
Sarah Howell: It has continued to grow year-on-year. It is still significantly under-penetrated, as we spoke about, only around 25% of that 4 million addressable patient population in the US are using an insulin pump or an AID system today. In the US alone, if we look now at AID sales, this is the pump and the consumable sales, it represents around a $20 billion revenue opportunity for the insulin pump companies. That is if all of the 4 million patient population moved over to AID, that would be the revenue-generating opportunity.
Sarah Howell: But really, to do that, we need to deliver on these three pillars: longer wear, smaller pumps, and enabling fully closed-loop systems. It is only a highly concentrated ultra-rapid-acting insulin that can deliver this, and Arecor does have the only insulins that we are aware of in development that meet this profile.
Sarah Howell: That is why there is a good synergy here and a strategic fit with Arecor and the insulin pump companies. If we just talk a little bit around the development and regulatory pathway here, I think as everybody knows, we have conducted four phase I clinical studies across our platform of insulins. So two for AT247, which is our 100 unit per mL insulin, and two for AT278, which is our 500 unit per mL insulin here.
Sarah Howell: This is covering both type 1 and type 2 patient populations, and we have also got data through delivery through insulin pumps as well. This gives us that confidence that we can demonstrate that superiority against those best insulins available today, and we have demonstrated superiority across all of those clinical studies. We have had significant interactions with the FDA over the course of this year.
Sarah Howell: We have had two key meetings. You can see on this slide, this is the Type C and the Type D meetings that we have had with the FDA, and that is really locking down our approach to concentrated insulin, our platform approach, enabling us to leverage data across these different concentrations to follow this abbreviated pathway to market, and really gives us significant confidence around that phase II clinical study design.
Sarah Howell: We have been to the FDA with that clinical study design and our protocol, so very confident that that is what the shape of our clinical study and the design of our clinical study moving forward there.
Sarah Howell: Essentially here, we have an approach that we can enter phase II with either our two times concentrated insulin, which is AT290, or our five times concentrated insulin, which is AT278. For both of those, we can leverage our phase I clinical data to go straight into a phase II clinical study. I am sure somebody is going to ask the question, so I am going to answer it now.
Sarah Howell: The selection of which insulin we move forward into that phase II clinical study will very much depend on the outcome of the partnership negotiations with the insulin pump companies there and the priorities on concentration across those insulin pump companies, because it is really important for Arecor that not only do we develop an insulin and bring that insulin to market.
Sarah Howell: We are really confident about the development pathway moving forward, the data that we need to generate to submit for our BLA and for marketing authorization. It is really important that the device and the AID system is on market to be able to deliver a concentrated ultra-rapid-acting insulin, so it has label approval for an Arecor insulin at the same time. That will very much drive our decisions there.
Sarah Howell: Now, an additional question I am sure that somebody may ask here would be, well, do you need to perform a phase II and a phase III clinical study of this size and magnitude for each concentration?
Sarah Howell: We do not believe so. Here again, we have had very positive discussions with the FDA around our platform approach here, so we would expect that to bring a further concentration to, or a different concentration to patients within that 100 to 500 units per mL, be a small bridging study to this data package that you see here today.
Sarah Howell: So there is a real opportunity to address the near and medium-term patient needs, getting patients to 3-day wear, moving type 2 patients across to AID systems, and enable that fully closed-loop, and also then in the future to have those insulins available for that further miniaturization of AID systems.
Sarah Howell: Very much a platform approach here. If we look at moving forward for the outlook for the company, of course, we have our best-in-class concentrated ultra-rapid-acting insulins. I hope, as we have been able to talk through today, you can see there is very much a high unmet patient need here in multi-billion dollar markets, and we have the only insulins that can address these challenges and enable that next generation of AID systems.
Sarah Howell: It is very clear that that is where the market is going and where industry is going. It is what the patients are looking for and very much what the insulin pump companies are committed to here. As I said, we are in those key and very much engaged heavily in those partnering discussions with multiple insulin pump companies here to bring an Arecor insulin AID product to market, and they are at term sheet stage now.
Sarah Howell: What is coming up? We are looking at our intention, of course, is to partner with multiple insulin pump companies here to take our insulin forward. That allows us to bring an insulin to market that has the broadest addressable patient population. We would like our insulins to be available for use in as many AID systems as possible, and of course, that will allow us to initiate that phase II clinical study.
Sarah Howell: We will be very busy doing everything we need to do to be ready for that clinical study, and then we will be able to select which pump system we move forward with, and also have that pathway through beyond phase II and beyond. So, we have a laser-sharp focus on our diabetes and insulin portfolio, and of course, in addition to that, we have that upside potential from the oral delivery of peptides.
Sarah Howell: If we can be successful there, it brings very significant value creation opportunities to Arecor and, of course, value to our shareholders. I would like to thank everybody for listening in today, and we would be very happy to take any questions that anybody has.
Operator: That is great. Thank you very much for your presentation this afternoon. Ladies and gentlemen, please do continue to submit your questions just by the Q&A tab situated on the right-hand corner of your screen.
Operator: Just while the company takes a few moments to review those questions submitted today, I would like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via our investor dashboard. As you can see, we have received a number of questions throughout today's presentation. Sarah, can I please ask you to read out the questions and give responses where appropriate to do so, and I will pick up from you at the end?
Sarah Howell: I will. There are quite a few questions. I am just quickly scanning. I think a number of them are across the same themes, so I will try and answer these without going over the same ground again. First question is quite long, but I am going to try and paraphrase this first question. I think it is generally around asking around how the interplay between the Sequel deal that we have previously announced and what we have announced during the results this year around being in the multiple negotiations with multiple insulin pump companies.
Sarah Howell: With respect to Sequel, as everybody knows, we entered into a co-development agreement for phase II readiness with Sequel Med Tech in 2025, the back end of 2025. That is still very much active. We are working very positively and collaboratively with Sequel Med Tech, developing the data package that is needed for AT278.
Sarah Howell: This is our 500 unit per mL insulin, and in parallel to that, very positive negotiations with Sequel Med Tech for a further agreement. That was for phase II and beyond. That is very much alive and active today, and very much focused on AT278. In addition to that, and I think as we have spoken about today, it has been clear that there is also a nearer-term focus on AT290.
Sarah Howell: That is our 2 times concentrated insulin there, and some advantages when we look at development and life cycle management. Addressable patient populations with existing commercially available pump and AID platforms, whilst having AT278 as well to further expand and allow that miniaturization of pumps and that future innovation that I think across the board all of the insulin pump companies are looking to achieve there.
Sarah Howell: So, I think the next question was around, are we moving forward with one or moving forward with both here? Arecor could move forward with deals across both AT278 and AT290, so that is our U-500 and U-200 insulin there. We will nominate one of these insulins for this first phase II clinical study here, and the reason for that being that we do not need to repeat all of this clinical data and all of the clinical studies for approval of each insulin.
Sarah Howell: So, we will be leveraging the data that we generate through our phase II and phase III programs to be able to go for approval for additional concentrations with very focused and abbreviated clinical bridging studies there.
Sarah Howell: So, we will essentially make that decision on which product we nominate to go into phase II with based on the outcome of these partnering and deal negotiations across all of the insulin pump companies that we are discussing this with today. I think just following on from that, there is a question around can we confirm if negotiations with multiple insulin pump companies means more than two?
Sarah Howell: I am not sure what we are supposed to say on here, but I am going to say yes. So, yes is the answer, short answer to that question. If you just bear with me, because there are quite a lot of questions. The next question is, "AT247 went quiet and has now resurfaced as AT290. Please amplify." Yeah, that is a good question, and this is really around our platform approach here. AT290 is essentially a two times concentrated AT247.
Sarah Howell: So, we are using the same formulation here and the same formulation approach. We have simply doubled the concentration here. We can do this with confidence because we know we can take the concentration up to five times and still demonstrate that superiority of our insulins compared to Novo's and Eli Lilly's insulins that are approved for use today. This is what also enables us to move directly into phase II.
Sarah Howell: So we could move directly into phase II with AT290 because we would be leveraging that AT247 phase I clinical data. We can essentially use that to demonstrate the safety and effectiveness so far, and the PK/PD superiority of our insulins to move straight into a phase II clinical study for AT290. So we are very much leveraging that AT247 data, and that data is really valuable for us. Otherwise, we would need to run those phase I clinical studies for AT290.
Sarah Howell: So it has allowed us to leverage that data to go straight into, or potentially into a phase II clinical study here. There is then a question really around market differentiation between AT278 and AT290. We have modeled this in a huge amount of detail around what is the initial addressable patient population for if we went with a two times concentrated insulin, and then how do we further expand that with a five times concentrated insulin?
Sarah Howell: What does it look like if both concentrations of insulin are on the market together? I think the answer here, and you probably see this best I am just going to go back actually to the heat map slide. You can probably see this best when we look at the heat map slides here.
Sarah Howell: If we look at the type 2 patient population, and if we assume here that these AID systems are going to go to 7-day wear plus, for example, then of course, existing insulins just simply can't achieve this. A U-200 insulin, so AT290, would get around 40% of your patient population to 7-day wear, but you soon start needing AT278, which is your five times concentrated insulin.
Sarah Howell: But the story, of course, is quite different for a type 1 patient population, and this is because their daily insulin needs are lower than the type 2s. So actually here, a U-200 insulin, so an AT290 insulin, gets the vast majority of that existing patient population to 7-day wear. That's why there's different pulls really for different concentrations of insulins from the insulin pump companies and AID systems. It partly depends on the size of their cartridge.
Sarah Howell: I'm showing you here the data for a 3 mL cartridge. Tandem and Insulet, who are the other two out of the three big players, MiniMed, Tandem, and Insulet are the three really. It also depends on how small are these pumps going to get, how miniaturized are the insulin pump companies going to go here.
Sarah Howell: Partly for them to make those development decisions and make those leaps into miniaturization, they need to know that Arecor's insulins are coming to market, and they need to know that they will get access to them, which is part of the discussions and negotiations here around structures of deals. The question around timing, essentially, I won't read the full question out, but I think it's essentially asking us when are we going to do the deal and when are we going to announce a signed deal.
Sarah Howell: I mean, it's absolutely our laser focus right now. Our focus is around deal with the insulin pump companies. These deals are looking at both what Arecor requires from these partnerships is development commitments from the insulin pump companies. We need to see that they are committed to developing their pumps and their systems, so that's both their algorithms and their insulin pumps.
Sarah Howell: You're moving the slides, David. The insulin pumps associated with these systems to be enabled, that next generation. We need those development commitments from the pump companies and their support during our clinical study phases as well. Within those structures, we're negotiating and discussing their financials as well in terms of supporting and financial support across the development programs and those clinical studies as well. That's absolutely our laser focus.
Sarah Howell: We're really cognizant of the fact that we want to do the very best deal that we can for our shareholders, but we need to do that in a timely fashion as well. We've extended our cash runway through to the end of 2027 to strengthen our balance sheet for those negotiations. We don't intend to be running out towards our cash runway on these deals.
Sarah Howell: We'll do them as soon and as quickly as we can, whilst ensuring that we do the very best deal for Arecor and our shareholders. There's a question around exclusivity. Are the multiple partners seeking exclusivity? I think Arecor's priority here is really clear. It's for us to be able to make our insulins accessible for as many people living with diabetes as possible. That is how the system works today.
Sarah Howell: Patients have a choice on which insulin pump they want to use, which insulin they want to use, what algorithm they want, even down to the CGMs, which CGMs do they want to use. It is a very interoperable system. We want to maintain that. The advantage for Arecor here is that we have the only insulin, the only concentrated rapid-acting insulins that can meet these profiles here, so it would be the insulin of choice across multiple AID systems.
Sarah Howell: Our focus here is very much on partnering more broadly, which allows broader access to the patient population, which of course then also provides the greatest commercial opportunity and value-generating opportunity for Arecor. I mean, leading on to that, there is a question around who is the competition for improved insulins here? We are really confident on this.
Sarah Howell: We are really confident that we have superiority in terms of our PK/PD profile, so absorption of insulin and speed of glucose-lowering action. We have purposefully gone head-to-head with the best insulins out there today. Remember, these are insulins all at 100 units per mL, aside from, some may remember our data for AT278, where we also went head-to-head with an Eli Lilly product, which is Humulin R U-500, which is the only other 500 unit per mL insulin there.
Sarah Howell: We have shown absolute clear superiority there, that our insulins are absorbed and much faster. So we are really confident on that. We are also confident that there is no other clinical data out there demonstrating that anybody else has been able to achieve this profile. We clearly monitor the space very closely, both in terms of clinical studies, clinical data, but also IP landscaping here. So we absolutely have first-mover advantage here.
Sarah Howell: We have very broad and comprehensive IP protection around our insulins. The key for us now is moving forward at pace, so we take advantage of that competitive landscaping and position and leadership position that we have, which minimizes the risk, of course, of any companies coming out of stealth mode with an alternative approach or alternative technology to achieve this.
Sarah Howell: There is a GLP-1 question next, but I am going to come back to that. I am just going to sort of scan through for questions around the insulin. The next question is, what is the business model for patients buying insulin? Again, if we talk about the US at the moment here, which is the commercial case that we have presented today. Patients are prescribed insulin via, for type 1s, an endocrinologist. For type 2s, it may be an endocrinologist, so a specialist physician or a primary care physician.
Sarah Howell: But essentially, they go for a meeting with their physician, and their insulin is prescribed there. In that same visit to their doctors, they are also prescribed their insulin pumps as well. These are two separate prescriptions, but very much prescribed in that same visit.
Sarah Howell: So you can imagine if a patient has a preference for a small, longer-wear pump, and that is what they are asking their physician to prescribe for them, then if Arecor maintains this position and we have the only highly concentrated ultra-rapid-acting insulin, it will be the only insulin of choice to be prescribed there for use in that AID system. So we very much get a halo effect here in terms of that prescribing and uptake and use of our insulins, because they will be the only insulins that can be used in these AID systems.
Sarah Howell: In terms of how they are paid for and reimbursed, the majority of those patients in the US will be under some insurance there, so their payers and their insurers will pay for that insulin. There are some co-pays that the patient is required to pay there as well. Arecor's approach here is about bringing superior insulins to market at no extra cost to the patient themselves. We are looking to increase those co-pays, for example, there, and the rest of those costs are covered via their insurers.
Sarah Howell: A probably important point to note is when we talk about this initial $3 billion market opportunity, we have calculated this based on parity pricing to those existing 100 unit per mL insulins today. This does not incorporate any consideration for a premium pricing for Arecor's insulins here. We have taken a low-risk approach to our commercial models.
Sarah Howell: There is a question around any more technical work required for AT290, so this is a 200 unit per mL insulin. I think as we have spoken about today, this is very much two times concentrated AT247. It is the same formulation. In terms of all of the non-clinical data, safety data that we have there, and phase I clinical data, will be leveraged and used for AT290.
Sarah Howell: So, we would intend to go straight into a phase II clinical study and not require to repeat any of that data. We have already demonstrated that with the FDA there. We used AT247 data, our non-clinical data, for example, and early clinical data to support AT278 as well. We did not have to repeat that data to go into the clinic for AT278. There is a question around how well is Sequel rolling out their pump there.
Sarah Howell: Sequel, a private company, I think as everybody knows, in the US, and they have not themselves put out any public numbers around patient populations there and the uptake of their pump. But I think what they would be comfortable and are saying, and they talk about publicly as well, they are very much tracking there against their forecasts.
Sarah Howell: They are seeing good uptake of their insulin pump, and we are certainly seeing that as we see the commentary around the patient groups, et cetera, that their twiist pump, the Sequel pump, is being well received. Importantly, for Sequel, they strategically very much see that concentrated ultra-rapid-acting insulin is critical for that future expansion of patient population and to be competitive there with AID offerings on the market, which very much fits in with Arecor's portfolio. There is a question just Pen field sales forces.
Sarah Howell: If so, would you not be better off partnering with the pump manufacturer with the biggest sales force? I mean, it is an interesting question, actually. In terms of the sizes of the sales force, if we look at how the patient population is split between the pump companies and also how those revenues currently are split between the pump companies, then very much Insulet, Tandem.
Sarah Howell: I am just going to go back so you can see. Insulet, MiniMed, and Tandem are the top three players at the moment by market share. It is not surprising. They have been on the market for the longest here with their AID systems and innovating for a number of decades, in fact, with their AID systems. Between the three incumbents here, they have about 90% of the revenue and patient population by share.
Sarah Howell: We have Sequel and Beta Bionics, very much new entrants to that market that are building their market share. This is within the US here. They are building that market share here. In terms of sizes of the sales forces here, actually, and I think we talked about this previously, Sequel have really entered the market with an ambition to be number 1 in the AID systems.
Sarah Howell: They have some technology around that as well, as we know, but they also have launched with a full-size national sales force. So their sales force is the same size as MiniMed and Insulet, for example. So they have a very large sales force. Our strategy here really around partnering is how do we get access? How do we get our insulins to the broadest patient population?
Sarah Howell: We know that patients like choice here, so logically that flows through that if our insulins are available in multiple pumps and multiple AID systems, we give ourselves the biggest opportunity to see the largest conversion of patient population to our insulins. That is very much our strategy here, is to move forward with multiple partners.
Sarah Howell: I am just looking to see if there is any more insulin questions before I move to the GLP-1. There is a kind of broad question that I will try and answer. Any news from EASD? So, EASD is the it is a very large, it is the largest European diabetes conference, which was held a couple of weeks ago. I was there alongside some of the Arecor team there.
Sarah Howell: I think, you know, my focus and the reason I was there was very much to meet with the insulin pump companies in person, or the senior teams from the companies come to these big meetings. Certainly had very positive and continued discussions and negotiations around what these partnerships look like and structures, et cetera.
Sarah Howell: So, you know, really positive set of meetings for sure at EASD. I think the other piece is, you know, there is very much a theme here at EASD that we are seeing through, and you can see it through what the insulin pump companies are announcing here, to get more Type 2 patient of the patient population over to AID systems, to move towards fully closed-loops. So that means not announcing meals, not having to tell the system that you are eating, so that means you need a fast-acting insulin.
Sarah Howell: Really around form factors, there was a lot around here that patients want patch pumps, and they want them to be as small as possible. So, we could see there the drive is very much towards these systems that require, quite frankly, an Arecor insulin there. So it is good to get that external validation, of course, that we are on the right track.
Sarah Howell: So, I think the last, well, the last question for now, unless there is any more to be submitted, is around GLP-1. So the question is, "There are quite a few GLP-1 drugs out now. How will yours differ from the others?" So, I mean, it is a really good question. It is a hugely competitive space, and there is a huge number of incretins, whether they be GLP-1s or a different form, mode of action here, essentially for the treatment of obesity here, with GLP-1s being one of those.
Sarah Howell: Our focus here is really around the issue of bioavailability. For GLP-1s, for oral GLP-1s that are available today in the peptide class, there is still this challenge of very low bioavailability, less than 1% bioavailability. That is our focus here, can we use our Arestat technology to improve bioavailability for GLP-1?
Sarah Howell: If we can do that for GLP-1 as a model peptide here, then the opportunities are twofold. Initially, it is around opportunities within that GLP-1 class. It is clear that less than 1% bioavailability is significantly suboptimal. It means 99% of the drug load is not active there. There are some commercial opportunities for GLP-1 to other peptides. There is a huge number of peptides in development today.
Sarah Howell: There is a real drive towards wanting them to be orally delivered, but this bioavailability has not been cracked to date, so they all suffer from very low bioavailability. If we can crack that, then that opens up partnering opportunities and transformational partnering opportunities with pharma for Arecor, and in the future, product opportunities for Arecor as well, leveraging that technology. I think, I am just going to double-check. Yeah, I think that concludes all of the questions today. Thank you, everybody, for a comprehensive set of questions.
Operator: That is great. Thank you for answering those questions you had from investors. The company can review all questions submitted today and will publish those responses on the Investor Meet Company platform. Just before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Sarah, could I please just ask you for a few closing comments?
Sarah Howell: Yeah, I think, I hope what we have been able to get across today is we very much have a laser-sharp focus on our insulin portfolio. That means getting into that phase II clinical study quickly, maintain that competitive advantage, and get these insulins to patients as soon as we can. That brings benefit to patients, but also, you have seen these are multi-billion dollar market opportunities here.
Sarah Howell: Our near-term priority is very much around finalizing these partnership structures with the insulin pump companies and then moving into our phase II clinical development. That really provides us with the absolute best opportunity to generate significant value for Arecor and our shareholders. That is our number one priority across the business.
Operator: That's great. Thank you for updating investors today. Could I please ask investors not to close this session, as you will now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete.
