Good afternoon, everybody. It's a pleasure to be here. Thank you for everybody that's taken the time to come today, particularly after a long bank holiday weekend. As you know, my name's Dr. Sarah Howell, and I'm the CEO of Arecor Therapeutics. I'm delighted to be joined today by David Ellam. Many of you will know that David joined us as interim CFO back in November of last year, and I'm very pleased to be able to confirm that he's now joined us permanently. Of course, David will be talking us through the financials later in the presentation today. We'll be talking through the results for Arecor Therapeutics for the year ending 31st of December 2024. Our customary legal notice, of course.
Just to give a very high level, I know certainly everybody in the room today knows the company very well by now, but Arecor are very much focused on transforming patient care by bringing enhanced therapeutics to market that reduce patient burden whilst improving outcomes. We do this by leveraging our innovative and proprietary formulation technology platform, Arestat, to develop novel formulations of existing therapeutics with these enhanced properties. We are very much targeting areas of significant unmet patient needs in high-value markets, either ourselves through our clinical stage proprietary pipeline within the diabetes and obesity space that you can see here across our insulins and oral GLP-1, or via our partnerships with major pharmaceutical and biotech companies, which are under revenue-generating licensing models.
We have existing growing revenues and high potential across our proprietary products here to generate significant value and value return, of course, to our shareholders. Very briefly on our portfolio and pipeline here, we have a very broad and de-risked portfolio of both those in-house proprietary products and our partner programs. Across our partner programs, we have three products under license now at various stages of development, most advanced, as you know, being AT220, which is on the market globally now. Also to note here, I would note Sanofi as well. They're in their pivotal registrational study for that product, and they're giving guidance now of targeting submission within 2026. If they're successful there, we'd expect that to come to market within the 2027 timeframe. Moving on to the operational highlights, and this includes post-period events also.
If we look first at our proprietary portfolio across the diabetes and obesity space, we're able to report in 2024 fantastic phase I clinical results for AT278. This is our highly concentrated ultra-rapid-acting insulin. This was a study in type 2 diabetics with high BMI. These were overweight to obese patient population, and we demonstrated superiority here against two of the best insulins that are available to this patient population. I will do a very quick summary of that data shortly. We're also making significant progress towards striking a strategic partnership for the further development and commercialisation of AT278. Here we see the most value to patients and commercially in the use of AT278 in an insulin pump setting. I'll talk a little bit more later on about the patient need here and then the commercial opportunity that this can bring to Arecor.
Now, AT247 is the other insulin, clinical stage insulin in our development portfolio. This is a standard concentration, so 100 units per mil, ultra-rapid-acting insulin here. Again, we've demonstrated superiority across two clinical studies in type 1 diabetic patients. A number of device insulin pump companies are using this data and modelling this data in vitro with their algorithms to understand the improvements in time in range. This is time in good blood glucose range that can be delivered with the faster kinetics of AT247. We have our oral GLP-1, and this is part of our broader strategy to develop an oral delivery platform for peptides here. We've made significant progress here. Initially, in this in vitro stage, we're looking to stabilise the peptide within the oral delivery matrix, and we've been successful here.
We have a series of non-clinical pharmacokinetic studies, so PK studies are ongoing at the moment where we're looking at enhancing that bioavailability. We'll have data from these studies through the course of the second half of this year, which will inform our next development steps. Across our partner portfolio, which continues to grow, AT220, of course, is on the market. We're really pleased with the progress our partner is making here, and we're seeing as that's rolled out globally, and we're seeing growing revenue streams from the royalty-bearing worldwide license agreement that we have in place with that partner. We're also seeing a growing portfolio of both our pre-licensed technology partnerships. You might note we've entered into two further technology partnerships so far this year, and we'd certainly expect more of those.
Also, at the end of last year, we entered into a new exclusive milestone and royalty-bearing license agreement for a ready-to-use medicine. That partner's not disclosed at this stage, but that's called AT351 for now. Across our intellectual property portfolio, we've made great progress. This is obviously the lifeblood of the company. It protects both our Arestat technology platform, but those enhanced versions of products that we develop using the technology. We've had 17 key patents granted over the period in major territories, including increased grants and protection of AT247 and AT278. I'm going to talk a little bit more around our insulin proprietary portfolio now. Just as a quick reminder, AT247, as I've stated, that's our standard concentration, so 100 units per mil, ultra-rapid-acting insulin.
We've shown that superiority across both a single injection and a three-day insulin pump study in type 1 diabetic patients, and we showed superiority here. This gives us confidence that AT247 can be the insulin with its fast kinetics to enable a fully closed-loop automated insulin delivery system, sometimes referred to as an artificial pancreas. Here, the focus is very much around reducing burden. This is a 24/7 disease, of course, whilst improving time in range for people with type 1 diabetes. For AT278, we're really excited about AT278. It's a really unique insulin. It's the only highly concentrated, it's a five-times concentrated 500 units per mil insulin with ultra-rapid-acting characteristics here. This is particularly difficult to achieve as you concentrate up insulin. Physiologically, it should slow down its time-action profile and become much slower acting. This is what we've counteracted with the Arestat technology.
This is really around enabling that next real leap in insulin pump innovation here. This drive towards longer wear and miniaturized insulin pumps is important for patients and is not possible to achieve without a highly concentrated, very rapid-acting insulin. We are looking here particularly at people with diabetes with high daily insulin needs who are unable to transition to these aid systems currently, in particular type 2 diabetics, where in the U.S., the average daily dose is around 100 units a day for a person with diabetes that is using mealtime insulin, and less than 10% of this patient population currently use insulin pump therapy.
Just to very briefly recap on the data, this was a double-blind, fully randomized crossover study comparing AT278 to NovoRapid, and then we had an open-label arm for Humulin R U500 here. This is the pharmacokinetic data that you're looking at. This is in type 2 diabetic patients with this high BMI. What you can see here is AT278 in the yellow versus NovoRapid. This is Novo's 100 units per mil rapid-acting insulin in the blue, and you can see this shift to the left. This is demonstrating that post-injection we see a faster appearance of AT278 in the blood compared to NovoRapid and a greater insulin exposure over that first 60 minutes post-injection. We're getting more insulin on board much faster.
If you look at this in comparison to Humulin R U500, so that's the only highly concentrated insulin available to patients, and this is a product from Eli Lilly, you can see this has this very flat profile. We see a significant shift to the left, much more insulin on board, much faster with AT278 compared to that only highly concentrated insulin. We saw this data translate directly into the pharmacodynamic profile. This is essentially the glucose lowering profile. Again, we saw that AT278 compared to NovoRapid, we saw an earlier onset of insulin action. That's starting to lower the blood glucose very quickly and a greater glucose lowering profile in that first 60 minutes.
This is that really important time period where you've eaten food, your blood glucose has risen really rapidly, and you need insulin on board as fast as possible, bringing down that blood glucose to help you maintain a healthy time in range here. Again, significant improvement compared to Humulin R U500. Across this study and our earlier study in type 1 diabetic patients, where we also demonstrated superiority, this confirms that AT278, despite its five-fold increase in concentration, has a superior PK/PD profile. It's a faster acting insulin, better blood glucose lowering profile than those best insulins available today, regardless of whether you're a type 1 or a type 2 diabetic or with high BMI also. I'm now going to talk a little bit and show you some data to talk a little bit about why this is important.
It's that kind of so what question, really. What we're looking at here, this is data from the U..S. We're looking at type 2 diabetics in the U.S. that are using a mealtime insulin. What this heat map is showing you is what is able to be achieved with current insulins that are on the market today and current insulin pumps. Those insulin pumps can take between 180-300 units of insulin. If we map this against total daily insulin need for this patient population, what it shows us is that nearly all type 2 diabetics cannot make it to a seven-day wear system. They run out of insulin before they get to seven-day wear. Actually, more than 60% of this patient population can't even make it to the standard three-day wear today.
This is making those insulin pump systems and those aid systems impractical and inaccessible for a large proportion of the type 2 patient population. There is a real opportunity here with AT278, as you can see on the bottom row here. If we have a 500 units per mil insulin, only 10% of the type 2 patient population cannot make it to seven days, and they can all make it to the current standard of three-day wear. There is a real opportunity here to bring more of those type 2 patients over to insulin pump therapy. There is a huge wealth of real-world data out there demonstrating that people with diabetes do better on pumps. Really accessing this pump therapy and improving the outcomes for the type 2 patient population. This is not just a type 2 issue here.
Again, now we're looking again, this is U.S.-based data, but this is for type 1 diabetic patients here. As you can see, you know, to move towards a seven-day wear insulin pump, which is very much where the device companies are moving, 60%+ of type 1 diabetics currently can't get to seven-day wear in these systems. Again, if you move to a highly concentrated insulin such as AT278, then all of the patient population can get to that seven-day wear system. AT278 here has the real potential to catalyze that next development in longer wear insulin pumps. If you further miniaturize those, that exacerbates this issue, of course. You've got even lower volume to get that insulin on board. You most certainly need a highly concentrated rapid-acting insulin.
This would be a real step change towards simplifying care, reducing burden, and broadening the access for insulin pump therapy. If we look at how many of these patients are there and what is the potential addressable market for insulin pump therapy, again, to note, this is the initial addressable market. This is US-based only, and I'll talk a little bit around some of the opportunities and upside potential here. What we've looked at is two patient segments here. Essentially, segment A is people with diabetes that are on intensive insulin therapy regime. They're using mealtime insulin, but they require more than 100 units of insulin a day. This means they can't get to three-day wear. Insulin pump therapy is not accessible to them, so they're using multiple daily injections.
There are around 1.1 million out of the 4 million intensive insulin therapy patients in the U.S. today who fit this category. If we take the next category B, which we have modelled as people with diabetes that are currently using an insulin pump in the U.S., there are around 1 million people using an insulin pump in the U.S. today. The opportunity for them to move across to an AT278 device combination, driven really by that longer wear time, is around 1 million. If we take the net price of insulin in the U.S., it is $0.05 per unit. This incorporates all discounts, rebates, IRA, etc. It is a direct parity pricing model here. That gives you a total addressable initial market in the U.S. of just under $3 billion. Of course, this does not incorporate any miniaturisation of the pump.
If you further miniaturize that, obviously opens and broadens up the addressable patient population and then the insulin revenue opportunity. Commercializing outside of the U.S. obviously offers an upside potential here. We've not modeled and incorporated any share of device revenues here. Insulin pump revenues, of course, switching over and building out and penetrating that type 2 diabetic market would also increase insulin pump sales as well. How those are shared will very much depend ultimately on deal structure moving forward. There is significant upside potential here also. If we look at next steps for AT278 in development, we've been working really closely with a group of ex-FDA reviewers from the diabetes division, really looking at what's the most accelerated and efficient pathway to market here, whilst demonstrating and developing the data set that we're going to need for our differentiated labels for AT278.
We have mapped out an accelerated pathway to phase II clinical development. This would be a pivotal study and most certainly a value accretion point for Arecor, where we would be comparing AT278 to NovoRapid over a six-week crossover period here. This is continuous infusion. We would gain a wealth of data from this study. It would confirm the time in range. This is an important metric of keeping that tight control of blood glucose, pump precision, accuracy, really important, obviously, for a five-times concentrated insulin, and safety for the delivery of an ultra-concentrated insulin in the pump setting. We will be submitting a request to the FDA for a type C scientific advice meeting this quarter, and we would anticipate having full feedback within the second half of the year.
Just moving on to talk a little bit more about our oral delivery of platform peptides, even research and development here. You know, just as taking a step back, first of all, I mean, the oral delivery of peptides is extremely challenging. It's due to their molecular characteristics leading to very low oral bioavailability. Having said this, it's a really important class of therapeutics, and we're seeing a huge swathe of peptide therapeutics now in development. There are over 800 peptides in development, and over 100 of those alone are in the diabetes and obesity area. This is a significant challenge, but we see a real drive towards oral delivery, improving convenience and compliance for patients, which also then improves outcomes there. Now, we've selected GLP-1 as our first peptide, model peptide to develop the platform with. We're using semaglutide, which is the GLP-1 behind RYBELSUS.
This is because RYBELSUS is available in an oral form. It is one of only two peptides, actually, on the market today that are orally delivered. We have a direct comparison here that we can directly compare our technology platform and, importantly, bioavailability. Our target here is to enhance bioavailability and also through targeted delivery to circumvent the strict dosing criteria with RYBELSUS, where it has to be dosed on an empty stomach. RYBELSUS itself offers, or oral GLP-1 offers, a significant commercial opportunity in its own right. Despite that less than 1% bioavailability for RYBELSUS, it still reported sales of $3.4 billion in 2024. Obviously, for the treatment of diabetes and obesity, this class of therapeutics is really significant today. In terms of status, we have had initial positive results from the formulation development phase.
The first really significant challenge was around stabilizing the peptide, so stabilizing semaglutide within the oral delivery lipid matrix that we're using. Without something special here, it was simply too unstable to be a viable product. We've overcome that. We are now conducting a series of dog pharmacokinetic studies, really looking at optimizing that lipid matrix, those formulations to enhance bioavailability here. This data that we're generating from these studies will define our next development steps. What's really important to note here, this isn't just around oral GLP-1. This is around developing an oral delivery peptide delivery platform that we can expand across this class of therapeutics, which is a huge area and obviously offers a huge commercial opportunity for Arecor if we can be successful here.
I think I don't probably need to go through this, and I'm sure the people in the room have got a really good handle on this as well. There's been a huge amount of interest and explosion of dealmaking in the oral delivery space as well. This is a combination of in-licensing of product assets, of technologies, M&A, etc. This is really just a snapshot of recent and relevant deals, you know, starting with Novo Nordisk. The actual technology, an oral delivery technology around RYBELSUS, was not homegrown. It came via a technology company called Emmosphere, who they acquired for $1.8 billion back in the back end of 2020 for access to that technology for RYBELSUS.
Right through to last week, actually, there was a deal announced by SupraMed and Merck here, and that's Merck accessing on a non-exclusive basis an oral peptide delivery platform approach from SupraMed. What was quite interesting around that is that's based on preclinical data and non-clinical data. There's no clinical data for the SupreMed technology at this time, but as you can see, there are significant deal values here. There's also significant investment flowing into this area, which gives you a sense of the excitement and commercial opportunity here. What I would say before handing over to David to talk through the financials on this, these are formulation and drug delivery challenges, and that's what Arecor has proven, that we're able to deliver innovation in this space and develop technology platforms that our large pharma counterparts have not been able to achieve.
That's why we see this as a key area for us to focus our R&D efforts. I'm just going to hand over to David to talk through the financials.
Thank you, Sarah. Good afternoon, everybody. Extracted 2024 key financials. Revenues rose 11% to $5.1 million. The two areas of increase were the Tetris products and also in the AT220 royalty income. R&D expenses dropped $2.4 million to $3 million. That was savings in clinical study costs and also a $0.4 million saving in payroll costs. SG&A expenses remain flat at $6.2 million, but worth remembering that almost half of that is Tetris expenses. In 2025, those themselves will more than halve, and obviously in 2026, those will be zero. The exceptional items are the impairment of assets relating to Tetris, and that was reported in the January R&S.
The cash, $3.3 million, and that obviously was augmented by the net $5.8 million from the summer funding raise. The message in these key financials for us is that we've entered 2025 well-positioned to focus on our two core areas of focus. The AT278 ultra-concentrated, ultra-rapid-acting insulin. We're partnered with medical device companies and the oral delivery of peptides platform. In addition, the 2025 cessation of activities at Tetris will be cash generative. That is worth remembering that the operating cash flow out of Tetris in 2024 was $3.2 million, but we expect that to be positive this year. We also have the partner revenues will continue to grow, particularly the AT220 royalty income, where, as Sarah mentioned, our partner is making good traction and is selling within major pharmaceutical markets within the world.
We also have the cost savings that were enacted initially in 2024, and that's with a 32% reduction in headcount from December 2023 until today. That is going to drive further savings in 2025. These measures were the runway well into H1 2026, position Arecor to be able to focus our cash and people on striking a strategic partnership deal on AT278, and also to allow us to get to next stages in the oral development of peptides platform. Those are the two areas that we have identified that have the greatest opportunity to return shareholder value.
Thanks, David. Just to round off, really, as we talked around today and as David has just outlined, our real focus here is in areas that we can drive significant value and transformational value to the business and return that, of course, to our shareholders.
Our focus is very much on strategic partnership discussions and drawing those to conclusion with AT278, again, as we've talked about, the highest value area there being within that insulin pump setting and then ultimately bringing that product to market within the oral GLP-1 area. This is around developing that data set now and validating that data set for the oral GLP-1 across a series of PK studies. Importantly, leveraging that data to expand to additional peptides so that we can validate that as a broad platform technology for the oral delivery of peptides, which is a huge opportunity. We'd expect to see those growing revenue streams from both AT220, but also pharma partnerships. We're confident in entering into further partnerships throughout the year. Our focus here is very much on areas where there's high unmet patient need in large existing marketplaces.
That concludes the formal part of the presentation today, but be happy to take any questions from within the room today. Yeah, Karl?
On those deal sheets that you showed, there's quite a—Oh, sorry. Sorry. Yeah, so Karl Keegan, Singers. On the deal sheets, you showed that there was quite a lot of money going into like Series A for platforms. How do you see the Arestat platform sort of technically comparing, or have you done that analysis to see, or do you have a view that you can sort of allude to about where you might see some differentiation? Secondly, on from that, I mean, GLP-1 is a nice to have, but the other peptides, I mean, that really is the sort of the one that we haven't factored into our analysis as yet, correct?
Yeah.
Yeah, so maybe the first question in terms of, I guess what you're asking is, what are we going to bring to the table in oral delivery? How are we going to differentiate? Yeah. So, you know, what has succeeded so far in the oral delivery of peptides, albeit in noting there's only two marketed oral peptides today, has been permeation enhancers. This is increasing absorption across biological membranes, such as the intestinal lining, of course. You know, really the potential of these as a standalone has been exhausted. There are just those two products on the market. The field is really crying out for a radical new approach and innovation in this area, which is where Arecor comes in here.
What we're looking at is we're using novel combinations of lipids, so lipid matrices here that are designed to stimulate the natural kind of lipid digestion pathways with the stabilized peptide, and that's been stabilized using the Arestat technology as its cargo. Essentially, we're really smuggling the peptides in by natural processes. Now, there's a series of challenges there, once you're in, around stabilizing and protecting those peptides. We won't hesitate as well to combine this with permeation enhancers, protease inhibitors, all of those areas that can help refine and optimize and enhance. We're looking at all of those areas today.
The core of the technology really is around this really novel approach to use those natural processes of the body to get the peptide in, which we believe there, if we can be successful there, we'll be able to optimise that and really enhance the bioavailability as well. It is a different and novel approach to what's out there today. I've forgotten your second question, Carl, sorry. What was your second question? What do you see is the potential of—Ah, right, yes, yes, yes, yes, sorry. Yeah. Yeah, I mean, the highest activity for peptides at the moment is clearly in the diabetes and obesity space. You know, there's a huge number of peptides in development in this space, over 100. You're looking at second generation GLP-1s, GIPs, dual triple agonists there.
You know, by far our primary focus area is in the diabetes space, both because of the activity in the area, the patient unmet need, the size of the market, but not least because of Arecor's knowledge of diabetes and obesity space and expertise, and also our pharma relationships in that space as well. It makes total sense for us to start in the diabetes and obesity space. If you look beyond that area, there is an increasing use and development of peptides in neurodegenerative diseases and also oncology there. As you said, this is really around developing a platform per se across the peptide class, which then can be leveraged in different therapeutic areas. In some cases, we will be guided by partnerships there as well.
Julie Simmonds, Peel Hunt. I was just wondering on AT278, sort of how the progress with the discussions are going.
Given that these are with pump companies, I think from the commentary you've got, how working with one pump company helps you progress to reach the larger market?
Yeah, I think, you know, it's actually a really interesting space here, and it's certainly, you know, aligning strategically both from the pool, from the patients, and, you know, what the insulin device companies and our pump companies are saying very publicly towards this need for a highly concentrated rapid-acting insulin. I think if we look at, say, start with the type 2 diabetic patient population, both Insulet and Tandem, which are two of the top three in this area, now have label approval for the use of their pumps for type 2 diabetes. They've published their clinical studies.
They've shown between a 15%-20% increase improvement in time in range in the type 2 patient population when you switch from MDI to pump. This has translated into, you know, significant HbA1c improvements as well. Insulet in their study saw between a 0.8%-2.1% improvement in baseline A1c. These are really significant results here in demonstrating that, you know, people with type 2 diabetes will do much better using insulin pump therapy. As I've spoken about today, the challenge then becomes they're just simply not practical. They can't get to three-day wear. To really penetrate that patient population, there's innovation needed there. You need to get them to three-day wear and potentially to seven-day wear as well. They're also all really talking openly about next generation pumps, around patch pump technologies.
Insulet have a patch pump. Tandem have partnered with a Swiss company, AMF. Medtronic are talking, you know, very openly now about longer wear time patch pumps. They have even started publicly speaking about an all-in-one very small patch pump, which incorporates a CGM algorithm and the pump as part of their vision. Clearly, to get to any of these product concepts, you have to have a highly concentrated ultra-rapid-acting insulin, and AT278 is the only insulin that meets that profile. You know, in terms of tension there and competitive tension, Arecor is in a really great position. For us now moving forward, it is about doing the right deal. I think maybe your question, Julie, you were sort of alluding to, is it an exclusive with one, or is it a co-exclusive or open access?
You know, they're all on the table essentially in part of these discussions. We want to make sure that AT278 is available to the broadest patient population that we can because that's good for patients and obviously commercially very attractive. It is also around their, you know, moving it forward at pace now and having the right deal structures and the right investment around that to ensure that we can develop AT278 in the pump at pace and bring it to market as quickly as possible.
Hi, Ed from Singer Capital Markets. Just back to your oral potential peptide platform. I'm just thinking, how early do you think you'll be able to market that to potential partners? Is that potentially after their pharmacokinetic dog studies, or does it come a little bit later?
Yeah, and I think it partly depends.
You know, I think the deal that Merck did last week with SupraMed is a good example of what I would consider to be an early partnership deal here that's based on sort of preclinical PK data, no human clinical data there. You know, Merck have come in, it's on a non-exclusive basis at this stage. Obviously, it's a buy books. That value is a buy books deal value. We don't know how that's structured exactly, but it shows you there that the appetite from large pharma is significant here and they're prepared to come in early as well. Not necessarily waiting for what you'd historically expect for them to wait for human clinical data.
I think for us, it's going to be very much on a product-by-product basis and also looking at how do we generate and create the most value potential here across the platform and return that value to the business essentially.
Yeah, that makes sense. Thank you. Maybe on the pathway to a pivotal AT278 phase two, I was just wondering in terms of the IND, has it been guided by the discussions with potential partners, or is that something that you guys had always planned to do?
Y eah, this accelerated pathway to the phase two and then going straight into a pivotal phase two clinical study has been guided by both the ex-FDA reviewers, so they're from the diabetes division, but also in conversations with those insulin pump companies.
We have been really mapping out what is the most efficient and effective pathway to market whilst generating all of the data that we are going to need to get the very best label for the end product there.
Perfect, thanks.
Okay, I think if there are no more questions in the room, we will close the formal parts of the presentation.