Arecor Therapeutics plc ($AREC)

Earnings Call Transcript · April 23, 2026

AIM GB Health Care Biotechnology Earnings Calls 47 min

Earnings Call Speaker Segments

Operator

Operator
#1

Good morning, and welcome to the Arecor Therapeutics plc Investor Presentation. [Operator Instructions] Before we begin, I'd like to submit the following poll. I'd now like to hand you over to the executive management team from Arecor Therapeutics plc, Sarah, good morning.

Sarah Howell

Executives
#2

Thank you. Good morning. Good morning, everybody. Thank you for taking the time to join us today. So my name is Dr. Sarah Howell, I'm the CEO of Arecor Therapeutics, and I'm joined today by David Ellam, our CFO, and we'll be talking you through the full year results to 31st of December 2025. So our customary legal notice. So at Arecor, we're very much focused just as a quick recap. We're a clinical stage biotech company, as you know, and we're focused on developing superior therapeutics that can reduce treatment burden and improve outcomes, specifically for people living with diabetes, obesity and other cardiometabolic diseases. Our focus is very much on 2 core product areas being in the diabetes space and the oral delivery of peptides. And these are areas where there's significant unmet patient need that we're aiming to address with our superior products in high multibillion-dollar growth markets. So our lead program is our best-in-class insulin AT278. So this is the only ultra-concentrated, ultra rapid-acting insulin in development, and it's been specifically designed with this profile for use in next-generation automated insulin delivery systems, and I'll talk a little bit more just as a reminder around what we mean by an automated insulin delivery system, and I'll refer to them as AID systems. We're also exploring a next-generation drug delivery platform for the oral delivery of peptides where very poor bioavailability, less than 1% is the drug delivery challenge that we're looking to overcome. So the AT278 in terms of high-level status, we are very busy preparing for the Phase II clinical study, which is all on track, and that's with our partner Sequel Med Tech. And again, I'll talk about our partnership with Sequel Med Tech in much more detail. And then for the oral delivery of peptides and our focus now is on generating that key nonclinical pharmacokinetic data, which is essentially assessing the bioavailability, which is the challenge that we're looking to overcome. And those studies are ongoing through the course of the second half of this year. And both of these product areas, of course, are underpinned and leveraged. We're leveraging our innovative and proprietary Arestat formulation technology platform here. We also continue to partner with leading pharma and med tech companies. So we have partnerships, as you know, that we've previously announced with companies such as Eli Lilly, MiniMed who are actually now the diabetes division that spun out of Medtronic, they IPO-ed earlier this year and also Ligand Pharmaceuticals, amongst others, they are the companies where we've been able to publicly announce their names. So now I'm going to move on to talk a little bit more around our operational highlights here. So around AT278, obviously, our lead program there. We signed a co-development partnership with Sequel Med Tech about last year, around September time last year, where both companies are co-funding all of the Phase II enabling development activities required for us to file for an IND, so to file for clinical trial approval with the FDA in the U.S. We also had a very positive what's called a Type C advice meeting with the FDA. This is where we presented our Phase II clinical plans, our protocols for that study and also the data package that we intend to submit under our R&D. We have very positive feedback from the FDA there. So we're very confident there around that clinical study design and its improved ability to be able to perform that study, which will be a U.S.-based studies. Importantly, as part of that co-development deal, both companies, so both Arecor Therapeutics and Sequel Med Tech have confirmed the strategic intent to enter into a broader agreement that would be for Phase II clinical development through to commercialization. And the terms of that deal are very advanced stage now of negotiation. So we're confident around moving forward and entering into that next phase of that deal, which is very important for us in terms of taking AT278. Then on the oral delivery of peptides programs were initially focused in the GLP-1 space, and I'll talk a little bit more around why we focused on GLP-1 there. We've generated initial positive results stabilizing the GLP-1 or stabilizing that peptide under very harsh conditions that it needs to survive, and we filed new IP in that area. So that's a very positive first step. We've overcome our first challenge and obviously filed our IP so we can start to protect that space. And as I mentioned earlier, we're now focused on improving bioavailability in those animal PK studies. On the financing side, we entered into a royalty financing agreement with Ligand Pharmaceuticals. It's raising $11 million of nondilutive funding, of which we received $7 million upfront. And we've subsequently this year received further $0.5 million which is part of the $4 million in CVR. So we have an additional $3.5 million in CVR related to that royalty financing agreement that are obviously related to certain commercial milestones, and they all remain on track. So this has really strengthened the balance sheet for Arecor Therapeutics and allowed us the time essentially to negotiate the best deal that we can enter into that next phase of development for AT278. So we're doing that from a position of strength, which is very much our focus. So we have a very strong corporate and financial position. And now I'll hand over to David to talk about that in a little bit more detail.

David Ellam

Executives
#3

Good morning. So the key message that we have today is that we have secured a cash runway to Q2 '27 that allows us to focus on 2 core areas, the AT278 insulin and the platform for the oral delivery of peptides and specifically to be able to close a co-development and commercialization deal with the insulin AT278. Starting with the income statement. Revenues have increased by GBP 0.1 million, with that increase being down to formulation revenues. Obviously, the most sort of standout item on the P&L is the other income, GBP 5.5 million. GBP 5 million of that was the gain on the sale of royalty rights to Ligand. There was also GBP 0.3 million being RDEC, R&D tax credit income and GBP 200,000 of recharging to Sequel Med Tech under our existing co-development agreement. Operating expenses decreased by approximately GBP 0.5 million. We had a small decrease, you can see in the G&A expenses on the corporate side and then R&D expenses down GBP 0.4 million. Some of that is because within 2024, we had at the beginning of that year, costs remaining on the Phase 104 -- Study 104 Phase I for AT278. None of that in 2025, but we have started the Phase II pre-enabling costs for AT278 already. Profit and loss for the year, GBP 0.9 million. And then below that, the loss for the year from discontinued operations. So that is for the Tetris business, where we ceased operations in September 2025. Within that, we had a gain of GBP 0.4 million when we sold the rights to the non-Ogluo products to Aspire Pharma. And the numbers for last year were impacted by the $3.3 million impairment overall on the Tetris business. Next page, please. So we finished with the year-end cash of just over GBP 6 million. Obviously, the largest element towards that was the sale of the royalty rights, where we received GBP 5.2 million of upfront proceeds from Ligand. And we have received another $500,000 already this year in dollars, and we expect to receive another $0.5 million before the end of the year. Net cash used in operating activities for continued operations was GBP 3.1 million, which was greatly decreased from GBP 5.7 million in the previous year. As mentioned, this has all worked towards extending the cash runway to the second quarter of 2027. And then just lastly, on the discontinued operations, then we generated cash of GBP 0.7 million, whereas the prior year, we used cash of GBP 3.6 million. And that all comes from no more purchases of inventory and collecting all the receivables on the Tetris side of the business.

Sarah Howell

Executives
#4

Great. Thank you, David. So I'm going to move now to talk in a little bit more detail around our lead product asset, AT278. So I'll run through this relatively quickly because I would imagine a lot of people on the line today will be very familiar with AT278. Essentially AT278, we've taken existing insulin to insulin as part, which is used in Novo Nordisk insulin, and we've developed the first and only ultraconcentrated. So it's a 5x concentrated insulin, 5x those standard concentrations for best-in-class insulins available today and importantly, ultra-rapid acting insulin. We've developed and we've demonstrated superiority in its pharmacokinetic and pharmacodynamic profile. So this is essentially getting insulin on board post injection very fast and that translating into a very fast and greater glucose-lowering profile compared to those best-in-class insulins available today, and we've gone head-to-head in those studies and we've demonstrated that in both type 1 diabetic patients and also high BMI type 2 patients. So the whole of the addressable patient population, which, of course, significantly clinically derisks AT278. And as I mentioned earlier, it's been specifically designed to be using these automated insulin delivery systems, which is essentially where the patient will wear a continuous blood glucose monitor, which measures their blood glucose levels continuously in real time. Those measurements are fed to an algorithm, which calculates how much insulin is needed to keep that individual inside their target blood glucose range. And then that's automatically delivered via the insulin pump. And all this technology and systems, as you know, exists today is on the market, including via our partner, Sequel Med Tech. So I think it's important now to talk around what are the needs, why are we developing this highly concentrated rapid-acting insulin. But it's very clear from a patient perspective, patients are looking for -- when we look at AID systems, there's a whole wealth of data out there, real-world clinical and outcomes data showing that people with diabetes that require insulin have better outcomes. They have better blood glucose control and outcomes if they're using an AID system. But despite this, there's still relatively low penetration. I'll talk about those penetration rates shortly. So the question here is what -- how can we reduce that burden and lower the barrier to use for these AID systems, which will then ultimately lead to improved outcomes for the patient population. But what patients are looking for is they want to reduce burden. It's still relatively high burden to use these AID systems. They want to be able to wear their insulin pumps for longer. Current standard of care is 3-day wear, after which time they need to switch out their insulin. They might need to throw away a pump if there's a disposable patch pump, refill that, apply a new pump, which means lots of different infusion sites as well every 3 days. So they want to be able to wear them for longer. They want to fit and forget essentially. And they would like them to be smaller. They're still a very visible indicator. They wear these pumps, visible indicator that they're living with a chronic disease. Of course, if you want to have smaller pumps or you want to wear these pumps for longer, it means that you need to be able to get more insulin on board in a much smaller volume or a much smaller space. And AT278 is the only highly concentrated rapid-acting insulin that can achieve this. There's also a subset of the patient population, and I'll talk today around some of the numbers here that have high -- require high total daily doses of insulin. So we characterize this patient population of needing more than 100 units of insulin a day to control their blood glucose. And this means with the standard insulins that are available to them today and the current pumps that are available to them today, they can't achieve 3-day wear time. They can't get to 3-day wear, which is the standard of care without running out of insulin, which means it's not practical for them to use AID systems. So they're simply not using them, and they're using multiple daily injections. In terms of improved outcomes, and I've talked about this a lot in the past is that to improve outcomes, we need much faster-acting insulins that enable us to be more aggressive with those algorithms, which essentially means that we can drive and control higher time in range here. We can more tightly control blood glucose and improve that time in that healthy blood glucose target range, which ultimately leads to better outcomes. And all of this needs to be delivered clearly in an ecosystem that's cost effective for both payers and patients, which is where AT278 has an advantage because we're using existing insulins and existing infrastructure there. This is not a novel therapeutic in development. So these are very much the needs that all can be addressed with AT278 with its profile. So just zooming in and looking a little bit more around this longer wear. So very much the device industry and the insulin pump companies are moving towards longer wear. There are 2 insulin pumps that are approved for use for 7 days and the other insulin pump companies are performing studies and looking to achieve this 7-day label. But the challenge that they have is with their existing pumps and the capacity for insulin and only 100 unit per ml, so low concentration insulin being available for use in these AID systems is that a large proportion of the patient population can't get to 7-day wear. So if we look at the type 2 patient population, IIT is essentially insulin -- intensive insulin therapy. So these are candidates for AT278. Nearly 50% of that patient population can't achieve that current standard of care of 3-day wear, so they're simply not using AID systems. But as we see these pumps moving to 7-day wear or even beyond that, almost all type 2s would run out of insulin before they get to 7-day wear. So 7-day wear is simply not achievable today for that type 2 patient population without a highly concentrated insulin. As you can see here on this heat map with AT278, which is U500, almost all type 2s would be able to achieve 7-day wear in the current AID systems. And it's not just a type 2 problem. If we look at the type 1 patient population here, almost just over 50% of the type 1 patient population cannot achieve that 7-day wear with those current insulins, U100's, that's NovoLog, Humalog and all of them will get to 7-day wear with AT278 at a 500 units per ml concentration. So it really does allow us to open up that access to more people living with diabetes regardless of their daily insulin requirements. And then if we look at this in terms of patient numbers and market size opportunity, this is looking at the U.S. and U.S. will very much be our first launch market here. So in the U.S., there are around 4 million people with diabetes that are intensive insulin therapy. So there are addressable patient population. And of those, around 1 million require more than 100 units of insulin a day. So this is a patient population that currently are not using AID systems. They're not practical for use for them and they're also not reimbursable because they would simply go through too many pumps and too many consumables. And then there is approximately 1 million further patients who are currently using AID systems, but they're looking for longer wear, they want smaller pumps, and they want better outcomes, of course, and control, all of which can be used with AT278 or achieved with AT278. So if we look at that 2 million initial patient population, so we see these as first adopters and take the current net pricing of insulin in the U.S., and that's over a $3 billion market opportunity for AT278. Then there's additional growth opportunities as you look at further miniaturization. It pulls more of that 2 million patient population you see on the right-hand side here over to the left. If all of the patients in the U.S. were to switch to an AT278 or switch to AID therapy of insulin, it's around $5 billion TAM opportunity. And with AT278, we're looking to achieve significant market share within this multibillion-dollar market opportunity. And then if we zoom out and look at the AID growth, so this is actually the insulin pump market and insulin pump sales, not insulin revenue here. And we can see despite these challenges in terms of the requirement for a concentrated rapid-acting insulin, it is growing year-on-year. We're seeing more and more people moving over to an AID systems because they get those improved outcomes there. And this is where we're really looking at and in partnership with the AID companies really to open up further access because despite this growth in the U.S., AID systems are still used by only 40%, around 40% of the type 1 patient population and only 5% of that type 2 patient population. And the real challenge for the type 2 patient population here is that they generally have high, higher total daily dose requirements, which means that these AID systems are not practical and accessible to them today. So there's a real opportunity to open these up and open up the market using AT278 in combination with an AID system. And on this front, as I mentioned earlier, we entered into an initial co-development partnership with Sequel Med Tech. So both companies have committed $1.3 million to conduct and complete those Phase II enabling activities that are required for us to file for approval, so to file an IND for approval for that Phase II clinical study with the FDA. So very much showing both companies' commitment there and also financial commitments, of course, here. And that strategic intent for us to enter into this Phase II and beyond co-development and commercialization deal. And as I mentioned earlier, this is at advanced stages of negotiation now, and we're very confident at entering into this next phase of the partnership, which will enable us to commence that Phase II clinical trial during the second half of 2026. So just to take a zoom out a little bit further around what's the regulatory and development pathway to market. So as I mentioned, the activities for the Phase III clinical study are ongoing and on track here. We have very much confidence around that Phase II clinical study design where we will be comparing AT278 when delivered by an insulin pump and continuously over a 6-week period using the Twiist, so Sequel Med Tech's Twiist pump and comparing against NovoLog So this is Novo's best-in-class rapid-acting insulin, but it's only available at 100 units per ml. So AT278 is 5x concentrated, and there'd be around 90 subjects in that clinical study. And then we anticipate a requirement for a Phase III clinical study. We have modeled this based on what our large pharm counterparts have done in the past for approvals of reformulations of insulin. So a 6-month crossover study, again, comparing with AT278 to NovoLog and then 6-month open-label period. This is essentially where you continue to provide the drug for use for a further 6-month period and you can gather that data. This is a relatively conservative approach here, and we will most certainly be looking to work with the FDA to see if there are any opportunities to further accelerate and -- this Phase III clinical study in terms of its duration and number of subjects would be areas that we would focus on. And as it stands, that would lead to potential for marketing authorization in 2030. So just to really recap for AT278, Obviously, the non-dilutive funding that we talked about earlier with Ligand, the strength of our balance sheet has enabled us the time and balance sheet strength to support this next phase of strategic deal making with Sequel Med Tech and our focus is very much on entering into the best deal that we can with Sequel in a timely manner, obviously, pace here and time frame to market is key already. All of those Phase II enabling studies are on track here, and we intend to initiate that Phase II clinical study during the second half of 2026. So just moving on to the oral delivery of peptides. So I want to talk a little bit around the challenge and why we see this as an ideal challenge for the expertise and the Arestat technology platform that we have here at Arecor. So oral peptides generally an important class therapeutics. There are over 800 of them in development and clinical development now today. Many of those in this cardiometabolic space, and I'm sure everybody has seen those, particularly in the -- for the obesity indication as well. But despite this, there are only a very small number of orally delivered peptides on the market today, and that's because they suffer from very low oral bioavailability. And the challenge here essentially is when you try to deliver a peptide orally so you're looking at a capsule here, it has to go through very harsh conditions, through the GI tract and into the stomach. It's harsh pH. It has a very low acidic pH. We have all these digestive enzymes, which essentially degrade the peptide itself. So they're degrading the active therapeutic ingredient that we require here to be delivered to the cells and to be active here. So that's challenge number one. And as I mentioned earlier, that's the first challenge that we've overcome is stabilizing GLP-1, which is where we started this semaglutide in these very harsh conditions, and we filed IP in that area. And then the second challenge here is then getting the peptide across the absorption barrier here and into the cells. And the only thing that's worked to date or the only area that's seen any success, and it's incorporated into those peptides that are oral peptides that are on the market today is the so-called permeation enhancers here. But the challenge here with permeation enhancers are again, under these very harsh conditions, these acidic pHs that they're crashing out of solution that they're not soluble. So again, you end up with very little of these permeation enhancers in solution and enable to cross these absorption barriers and essentially shuttle that peptide through into the cells. And that's why we -- it results in this very low bioavailability of less than 1% for these orally delivered peptides. And that's why we're very much focusing now. So we're using our Arestat formulation technology and expertise to protect and stabilize the peptide. So we've got some novel formulation approaches there and also then to keep these permeation enhancers soluble as well so that they can encourage that uptake in the cells and improve that bioavailability. And some other clever formulation tricks that we've got within this matrix, which obviously, I won't talk about today, but will be within our IP filings here. So in terms of where we're at, we're obviously starting with GLP-1 here. We've had those positive initial results. We filed the IP and now we're generating that nonclinical pharmacokinetic data, so that bioavailability data here. If we can show success in the animal PK studies, so this is very much can we show improved bioavailability when compared to Rybelsus. So that's oral semaglutide that's on the market today, which has less than 1% bioavailability, and that's really highly translatable to other peptides. And from a business commercial strategy space here, this would then offer us the opportunity for more transformational partnering with pharma here. We know there is a high appetite for oral delivery technologies for peptides. We know scientifically, it's a challenge that nobody has really cracked to date here. And that would enable us to partner with pharma on proprietary peptide assets within their portfolio, which currently without a delivery technology will be developed as injectable therapies, but we know there's a high patient preference for oral delivery there. So that would enable and open up partnering within a multibillion-dollar market opportunity for Arecor. And I think as we can see in the space, I mean, we update this slide as new deals come through and the new deals all the time, the most recent Novo Nordisk with Vivtex there licensing some oral delivery technologies there, but it's a really active space here. There's a huge number of efforts ongoing in terms of trying to develop technologies and improve bioavailability. So we are in a race here. Of course, but this is a formulation drug delivery challenge, and this is our, of course, USP where we've been able to demonstrate over the years and validate that we can deliver enhanced formulation and drug delivery technologies that even our large pharma partners have not been able to achieve themselves. And there is high appetite in this space, clearly. So I think if we look forward in terms of summary and outlook, clearly for AT278, we have a very unique and the only highly concentrated ultra rapid-acting insulin in development. It's clinically derisked as we demonstrated superiority to those best-in-class insulins available today in both type 1s and type 2 patient populations. As we've spoken through today, there's an initial U.S. opportunity, market opportunity that translates to an over $3 billion insulin revenue opportunity with growth opportunities both within the U.S. but obviously upside ex U.S. as well. And it's really around catalyzing and opening up access to that next generation of AID systems, which will be longer wear, smaller and really continuing to improve that time and range of those clinical outcomes for the patient population. Importantly, we've partnered with a commercial stage insulin pump company, our AID company, Sequel Med Tech and confident in terms of entering into that next broader strategic deal for Phase II and beyond. As I just mentioned with the oral delivery of technology, peptide technology platform, we've overcome that first hurdle to stabilizing the peptide, now focused on that oral bioavailability in those PK studies and significant upside potential there if we can be successful. And what I would note as well in terms of investment here, it's very low capital investment and resource investment at this stage to get to that PK proof-of-concept point. These studies are not expensive to run. They just take time, unfortunately, and there's a series of iterative studies that we need to do there. And it's the scientists at Arecor, in-house scientists doing what they do best and being creative here around formulation and drug delivery technology. So low capital investment, but significant upside potential. So in terms of what to look out for, obviously, the next phases of our strategic partnership for AT278 Phase II and beyond, then leading into being in a position to initiate that Phase II clinical study. That, of course, is subject to funding. We're looking at co-development, current commercialization deal structures here with Sequel Med Tech. So Arecor, of course, needs to be in a position to be able to fund its proportion of that co-development and also that key pharmacokinetic data for the oral delivery of peptides platforms, which will inform our next development steps. Broadening out on success there, we build them out to other peptides and also partnering opportunities with pharmaceutical companies. So that draws the formal part of the presentation to a close today, and I'd be happy to take any questions.

Operator

Operator
#5

Thank you both for updating investors today. [Operator Instructions] Sarah, David, as you can see, we received a number of questions during today's presentation. If I could just hand back to you to read out the questions and give responses where appropriate to do so, and I'll pick up from you at the end.

Sarah Howell

Executives
#6

Sure. Thank you. So the first question is, I'm just going to read it out in full, as I always do, as you know. So given that the share price is around 29% of the IPO price, what fundraising options are being considered for the upcoming AT278 trial? Are any nondilutive options on the table? I was especially pleased with the previous nondilutive fund raise. So maybe I'll start on that, and I'm sure David will have some additional detail there. I mean, obviously, in terms of amounts required here, ultimately depends on the final structure of our deal with Sequel Med Tech. But I think as we've signaled and certainly with the first deal that we've done with Sequel to allow us to conduct those Phase II enabling activities, it was on a co-development. So that was a 50-50 funding basis. So it's on that co-development and commercialization basis that we're moving forward now in terms of those deal negotiations there. So options available to Arecor, of course, on funding would be traditional equity funding there. Obviously, all of our shareholders would be eligible to participate in that. So I would note that with the changes to the VCT guidance now, we are able to take advantage of that increased cap now to GBP 40 million where it's -- I've been talking to U.S. parties too much recently, GBP 40 million relative to the GBP 20 million previous cap. So it is important to note that our entire shareholder base would have the opportunity to participate should they wish to there. So that's obviously one opportunity. Of course, other areas such as nondilutive funding. We continue to explore all areas and all opportunities there. We obviously spent a lot of time on that last year, really understanding the landscape for nondilutive royalty financing and have built relationships there across that ecosystem there. So we'll consider all of those options. So our priorities here are to enter into the best deal with Sequel and to be cognizant and mindful of value share there and retention of value for Arecor and its shareholders. And then lastly, of course, around that kind of fundraising. We're conscious of the current share price, of course, and any impacts or effects of dilution. Sorry, David, I actually said more than enough. If you've got anything to add.

David Ellam

Executives
#7

Nothing to add.

Sarah Howell

Executives
#8

So I don't know why it's moving slides as I'm moving. Done. So the next question is, the recent patent application looked to include some very exciting looking graphs of bioavailability for tested peptide. It looked like several percent. Any comments? I mean the first -- in terms of that first IP where we're really focused is around stabilizing that peptide and also -- which was our first challenge and that's IP around composition of matter and formulations to protect that peptide. In terms of the bioavailability, we're still very much assessing that and assessing that's a combination of improved -- how do we improve bioavailability, and it's got to be in formulation matrices, of course, that are scalable within manufacturing as well. So we haven't, at this stage, filed specific IP around that bioavailability. Obviously, as we generate that data through the second half of the year, we'll be looking to assess that, where is our bioavailability compared to those commercial benchmarks in this case, Rybelsus. So it's a little bit of a watch this space for that one. And there's a question around when would we expect to see the first data from the oral peptide delivery program? So that's very much the data that we'll be generating through 2026, of course, it is iterative data. So it partly depends on the duration of these and when we have an understanding on a go/no-go point pivotally of are we improving bioavailability or not here is really each study informs the next. So it's actually difficult to say and put an exact that we expect to be by this time frame. But we certainly expect through the course of the year, we'll be generating a significant body of data here. So we'll be able to say much more about this as we go through the year and through the second half of the year. I think the next question is how are you balancing early partnering to derisk development versus advancing programs internally to capture greater longer-term value? So I think if this is not really the question, please add another comment. I think what this question is asking is around the balance of the tech partnering, which is fully funded by our partners. So those 3 pre-licensed partnerships such as the partnership we have with Eli Lilly and MiniMed, for example, where they are paying the development dollars to access Arecor's expertise. We're developing novel formulations of their proprietary assets under those agreements, which are fully paid for by their partners. And then there's the upside potential, of course, on licensing should they then decide to take those forward in development. So we very much -- we have a team, a small team internally focused on that. So they're focused on both bringing in those programs, but also obviously working on those and working on the development of those novel formulations under those programs. That's certainly ongoing, and it's still ongoing there. We have a number of programs already partnered and contracted that we're working on that have that upside opportunity as we go through that development. And we would expect to bring new programs in. But to be clear, the focus and certainly the senior focus within the business is quite rightly on those 2 core product areas because the value creation opportunities, particularly if we look at AT278 now being clinically derisked and an opportunity in a very large market with a U.S. partner really does offer the longest and the largest value creation opportunity for Arecor and our shareholders. So the next question is, how are discussions with Sequel progressing? When are we likely to see a deal for the Phase II? Good question. And they're progressing really well. I mean when we say -- we don't take it lightly to say that we're in advanced stages of negotiation. And obviously, these are areas that we discuss with the Board as well of are we all comfortable in keeping the ties on this, that it's right to stay advanced stages of negotiation. And that's a unanimous yes from both myself and David and the Board here that we are genuinely in advanced stages of negotiation here with Sequel Med Tech. So we are confident of moving forward on this deal. Really, it's around now it's fine-tuning. We're into the real detail around value share here and how do we have a fair value share when all parties are motivated and that we retain an appropriate value for Arecor for the proprietary product that we're bringing to the table here. So that's very much where we are now. It is really into the weeds of the detail. But we are confident of moving forward and confident of them being in a position to initiate Phase II clinicals in the second half of this year. So that gives you a sense of that time frame. We're not intending to be negotiating this deal through into 2027. So there's a question here around do we consider -- because of the share price currently and certainly since IPO, do we consider Arecor to be suitable for public markets? Obviously, the focus of Arecor is very much on these near-term value drivers. So we've got significant opportunity here to drive value for the business. I believe that will be value driven by entering into this next strategic co-development and commercialization. So this also gives a route to market with a commercial stage U.S. company that have a commercial sales force. And I think that will create value and then enable us to go to that next value inflection point on Phase II clinicals as well as that upside potential from the oral delivery of peptides. We obviously will always look at all strategic options for the business and make sure that we make the right decisions for the business at the right time to maximize the value and that opportunity to return for our shareholders. David, I don't know if there's anything you want to add on that one?

David Ellam

Executives
#9

I think probably in relation to the last part of the question was about, are companies such as Arecor suitable for public markets? And I think that part of the discussion here is on the undervaluation. And obviously, the Board, management, people we speak to externally see the large opportunity and the challenge there is reflecting that within the share price and obviously, signing a commercial deal, starting Phase II, those are both very important value inflection points for us on that journey to effectively getting a reappraisal of what the valuation of the company is.

Operator

Operator
#10

Thank you once again for answering questions from investors today. Before we ask investors to share their feedback, which I know is particularly important to the company, Sarah, perhaps I could ask you for some closing comments.

Sarah Howell

Executives
#11

Yes. I mean I think hopefully, what we've been able to communicate in the time that we have today, the company is very much focused. We're very much focused on those 2 core product areas. We have a clinically validated best-in-class insulin with a large patient unmet need there. So hence, leading into a large multibillion-dollar market opportunity, a commercial stage partner in Sequel Med Tech, a real opportunity there to drive significant value from that unique profile of AT278 and also that upside potential then from the oral delivery of peptides. We know it's scientifically challenging, but if we can be successful there, that's a huge opportunity. And as we talked around today, we still continue to leverage that Arestat technology platform and partnering with pharma as well, which obviously brings those revenues into the business. but also offers that upside potential in the future from licensing. So we're confident now moving forward. We've got a number of significant milestones through the course of 2026, entering into the deal with Sequel, generating the PK bioavailability data for the oral delivery of peptides. So real opportunities to add significant value to the business.

Operator

Operator
#12

Thank you both for your presentation this morning. Could I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback, which will help the company better understand your views and expectations. On behalf of the management team of Arecor Therapeutics plc, we would like to thank you for attending today's presentation, and good morning to you all.

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