Arecor Therapeutics plc (AIM:AREC)
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Earnings Call: H2 2021

May 5, 2022

Operator

Good morning, ladies and gentlemen, and welcome to the Arecor Therapeutics plc year-end results 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 that's just situated on the right-hand corner of your screen. Please simply type in your questions and press Send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company will review all of the questions submitted today and publish responses where it is appropriate to do so. These will be available via your Investor Meet Company dashboard, and we will notify you by email when these are ready for your review. Before we begin, I would like to submit the following poll, and if you could give that your kind attention, I'm sure the company would be most grateful.

I'd now like to hand you over to CEO Sarah Howell. Good morning to you.

Sarah Howell
CEO, Arecor Therapeutics plc

Good morning. Thank you, Jake. Good morning, everybody. Thank you for taking the time to join us today. It's a pleasure to be here. My name's Dr. Sarah Howell. I'm the CEO of Arecor, and I'm joined today by Susan Lowther, our CFO. Today, really, we'll give you an introduction to Arecor, our technology and the proprietary products that we're developing, and also cover some of the highlights from our year ending 31st of December, 2021. Just draw your attention to our customary legal notice. By way of introduction, at Arecor, our purpose here is to transform patient care by enhancing existing therapeutic medicines so that they're safer, more effective and affordable. We do this by leveraging our innovative and proprietary formulation technology platform, Arestat ™ , that we develop novel formulations of existing therapeutic products that enhance their properties.

As a technology platform company, intellectual property is absolutely critical to us, and we have very broad and robust IP protection of both the Arestat ™ platform itself, but also the enhanced versions of therapeutic products that we develop using that platform. We are a clinical-stage pharmaceutical company. Our first area of therapeutic focus is in the diabetes space, where we're using Arestat ™ to develop much faster-acting and more concentrated, faster-acting insulins, and I'll talk about those in a little bit more detail later. We've also expanded further into an area that we call specialty hospital products. This is where we're taking products that are already on the market, but used in the hospital setting, often in chronic care for oncology, for example, or in emergency use. However, those products are only currently available as in powder forms that require a complex mixing procedure prior to use.

Here we're able to use the Arestat ™ technology to develop stable liquid, ready to use and ready to administer versions of these products. Which means that they can be used safely and effectively and quickly, importantly, at point of care. We've entered into, from our specialty hospital franchise, we've licensed two of these products to Hikma Pharmaceuticals under co-development and licensing agreements, and they're progressing well through development currently. Again, I'll talk about those. Our strategy overall from our proprietary pipeline is to develop these closer to market to a higher value inflection point prior to partnering with major pharmaceutical companies for late-stage development and/or commercialization under our technology licensing model. Alongside our, in-house proprietary products, we also partner with leading pharmaceutical and biotech companies.

This is where we work on their proprietary products in-house at Arecor, and we're applying the Arestat™ technology platform to develop superior versions of their products. These could be products that are either in development or on the market as lifecycle management. This is a revenue-generating model. Our partners pay Arecor to perform the development work, so that's the application of the Arestat™ technology. When we've developed a novel formulation of their product with enhanced properties, they have the option then to take that further forward in development and ultimately to market under a technology licensing model. These tend to be milestone and royalty-bearing. Overall, we're very much a commercially focused business. We have revenue-generating partnerships with leading pharma and biotech companies, and also upside potential from the future partnering and licensing of our proprietary product pipeline.

As many of you may know, we also had a very successful oversubscribed AIM IPO in 2021. We're using those proceeds to further enhance and develop our proprietary product portfolio. Just looking at some of the operational highlights from 2021, and this also includes some of our post-period events. In terms of our proprietary product pipeline, we made very significant clinical progress across the year, and that's flowing into 2022. We received, and we're very pleased to receive, IND clearance from the FDA, that's the U.S. regulator, for our second clinical study for AT247, which is our ultra-rapid acting insulin. This study is ongoing in the U.S. at the moment, and it's a three-day insulin pump study. I'll talk a little later around why that's so important.

We're also really pleased to be able to announce very positive results for our AT278, which is our ultra-concentrated rapid-acting insulin. This was a phase I first in man trial. Those results certainly hit the high end of our expectations. Again, I'll talk you through those. Earlier in 2021, we were awarded a GBP 2.8 million Innovate U.K. grant to support the phase II clinical development of AT247. Preparations for that study are ongoing at the moment, and that can start and initiate after we have the results from the current U.S. study that's ongoing. We also, as I mentioned, we partner with major pharmaceutical and biotech companies, and we entered into five new technology partnerships in 2021. These are revenue generating but pre-licensed at this stage to offer that upside potential from milestone and royalty-bearing licenses.

As you can see here from some of the names of the companies that we're able to announce, such as Eli Lilly, Par Pharmaceutical and Intas Pharmaceuticals, we're partnering here with well-established and large pharmaceutical companies, and that really does validate the strength and the need for the technology and also our commercial focus. We do build relationships with pharmaceutical companies and we do deals with them. We've also had some significant progress across our intellectual property portfolio. I'd note earlier this year, in fact, we had our first U.S. grant of one of our key patents protecting AT247 and AT278, which is part of a much broader strategy to protect those valuable product assets. Just zooming in a little bit to the technology, just to give you a feel for what the technology platform really is.

As I've mentioned, we're taking products that are suboptimal in some way, applying the Arestat ™ technology platform to develop enhanced or improved versions of these products. Some examples of these are, as is in the case with our insulin products, we can take those products and use our Arestat ™ technology to modulate and change the pharmacokinetic and pharmacodynamic properties. This means that we're changing how that drug works post-injection here, and here we're accelerating that absorption and making very rapid-acting insulins. We very routinely work on taking products out of the cold chain and developing heat-stable versions of those products. Obviously, that's been very topical over the last two years now, I guess, with the COVID vaccine. We saw those first vaccines coming to market requiring minus 80 degrees, being stored and distributed on dry ice.

Those are the kind of programs that we work on with our partners, taking those products out of the cold chain. As is the case with our specialty hospital portfolio, we also work routinely on taking products that are dry powders that require this complex mixing procedure at point of care and developing stable liquid ready-to-go versions of these products. We're also seeing very much a trend towards trying to take patients out of the hospital setting. One area here that we work in, both ourselves and with our partners, is taking products that are currently administered via an IV infusion in the hospital setting and developing very highly concentrated and stable versions of these products that can be delivered then via a single injection.

Then opening up the opportunity to take that patient out of the hospital setting, even to self-administration at home. The technology platform itself here, we're taking a suboptimal product, we're applying our Arestat ™ , develop an enhanced version of that. Essentially the platform is a series of tools, and each of those tools is a very specific combination of ingredients or excipients that have been designed and developed by Arecor to enhance specific properties of a product. When we work on a program, whether it be an in-house development product for Arecor or one of our partner programs, we start in the same way. The first thing that we'll do is define the target product profile. What are the enhancements or properties that we're looking to achieve?

Once we've defined that, we use our internal expertise and know-how to then understand what are the problems that we need to overcome, what's preventing those enhancements or properties being achieved today. Once we've defined that, we then select specific tools from our platform, each of those tools and each of those combinations of ingredients then being designed to overcome and enhance a specific property. Now, these are complex, often biological products that we're working on here, so there's always more than one challenge that we need to overcome. We'll select those tools that overcome each of the challenges that are required for that particular product. We might, for example, select tools one, three and five, for example.

We'll combine those together, which means combining all of those ingredients together with the pharmaceutical product within our labs in Cambridge in the U.K., and then test that product. What we're looking for here is are we seeing broadly the enhancements of properties that we'd expect to see? Once we know we're in the right design space, this is where we use our proprietary algorithm, which helps us fine-tune and select the exact ratios of those ingredients or excipients that will give us the optimum product profile and the optimum enhancements of properties. Using this process, which is very transferable and scalable, we're able to routinely develop enhanced versions of products that were otherwise unachievable.

As I mentioned earlier, of course, intellectual property is absolutely critical here, and we have over 50 granted patents currently and of course, a growing and evolving patent landscape. Just moving on to our portfolio here. What you're looking at here is a combination of course, proprietary products in the dark blue and our partner programs in the orange. Perhaps if we start with our proprietary products in dark blue, there's a number of important aspects to note here. The first is here that we're taking products that are already on the market and approved, such as insulin, and we're using Arestat ™ to develop enhanced versions of these. This is important because it means that the safety and effectiveness or efficacy of these products is already known.

This means that we can follow abbreviated regulatory and development pathways to market because we're not having to perform those long and often large and clinical studies to demonstrate the safety and effectiveness of the products. Here, what we're doing in our proprietary and clinical programs here are looking at demonstrating the superiority and the clinical benefit to patients. This means that we can develop these products in a faster timeframe to market and at a lower cost and lower risk compared to a traditional biotech model. As you can see here for our two lead diabetes products, AT247 and AT278, and we've performed two phase I clinical studies for these products. We're in a second clinical study for AT247, and we plan to enter our next clinical study for AT278 later this year.

Really, our strategy here is to develop those data packages that we know that pharmaceutical companies will be looking for for partnering, but also a data package which proves that clinical benefit to patients, which will be key for those patients, but also to ensure reimbursement of these products in the market. Here we'll be looking to take with our partner market share within an existing $6.4 billion market, and we'd anticipate these being milestone and royalty-bearing partnerships with those pharma partners. Perhaps moving on to the specialty hospital portfolio now. I'll start with our partner programs with Hikma Pharmaceuticals. These products started their life as Arecor internal products, so they were in our research group.

These were products that we'd selected that were on the market, used in the hospital setting, but these powders that required the complex and mixing procedure prior to use. For AT282, which is the most advanced of these programs with Hikma, for example, we developed a stable liquid ready-to-use version of this product in-house at Arecor, and then we filed intellectual property protecting that novel formulation and that new format of this product. It was at this stage that we entered into a co-development and license agreement with Hikma Pharmaceuticals. Here, we're not looking to change clinically how these products work post-injection, so this means that we can follow an even further abbreviated pathway to market. It's called a 505(b)(2) regulatory pathway in the United States.

What this means is that, there'll be limited or no clinical data required for approval here. With our partner, Hikma, and their capabilities and their commercial capabilities to bring these products to market, we'll be looking to take market share within those existing market segments. Around $600 million market, for example, for AT282. Perhaps moving on to AT220. This is an example of a pure technology partnership. This is where a pharmaceutical company has come to Arecor with their proprietary product, and we've developed an enhanced and superior version of that product with the Arestat ™ technology, and they've taken a license to that and taken it forward in development. AT220 is important because it's likely to be the first product on the market incorporating the Arestat ™ technology.

It's in late-stage development by our partner at the moment, and we'd anticipate this product, if successful, could be on market from 2023 onwards. Again, this is a royalty-bearing agreement to Arecor in an existing multi-billion dollar segment there. It could be generating recurring royalty revenue from Arecor from next year onwards. At the bottom here, you can see those technology partnerships. These are pre-licensed partnerships where we're working on developing those enhanced versions and superior versions of the products for our partners and offer that future upside potential from licensing. I'm now going to talk in a little bit more detail around our diabetes products. Maybe taking the macro view first. The International Diabetes Federation published their updated statistics for diabetes at the end of 2021, and they describe now diabetes as being in crisis.

There are actually around 537 million adults living with diabetes, and the cost of treating them and their diabetes complications is just under $1 trillion currently. Sadly, 6.7 million people died due to diabetes in 2021. Where Arecor is focused here, we're focused on developing improved insulins to help these people living with diabetes better manage their blood glucose and ultimately improve their outcomes. I'll try and explain this a little more in this slide here. The daily challenge for somebody living with diabetes is to try and maintain their blood glucose inside a healthy target range, which you can see in the light blue in this schematic on this slide. They can do this through most of the day and night, but the challenge becomes around mealtime.

When we eat food, our blood glucose rises very rapidly, and the fact is that the current gold standard best-in-class insulins on the market today, still not fast enough. There's still improvements to be made there to bring that blood glucose back inside the healthy target range quickly enough and counteract that very swift rise in blood glucose. As a result of this, on average, a person with diabetes spends around 25% of their time with their blood glucose too high, in hyperglycemia, and about 5% of their time with their blood glucose too low, in hypoglycemia. It's this time spent out of range that leads to the really serious disease complications associated with diabetes. For example, there's a 200% increase in all-cause morbidity and 70% of people with diabetes die from cardiovascular disease. Arecor is developing two superior insulins.

AT247 is an ultra-rapid-acting insulin, where we're really targeting an improved insulin and treatment option for people living with Type 1 diabetes. I'll talk through the data and why that is in a moment. AT278, which is our concentrated rapid-acting insulin, again, targeting improved treatment for Type 2 diabetics. Both of these products are novel formulations of existing insulin that we've enabled using the Arestat ™ technology. As I mentioned earlier, we have a very broad and robust patent strategy protecting these products with that first U.S. grant earlier this year, and we would expect patent protection out until at least 2037. If I move on to AT247, I'm going to talk you through our clinical data here for this study. In this study, it was a phase I clinical study in Type 1 diabetic patients.

We're able to go straight to the patient population because we're not having to demonstrate the safety of insulin, so we could skip the healthy volunteer phase. We were looking at comparing AT247 to the gold standard insulins which are on the market today. Both from Novo Nordisk, NovoRapid, which is their rapid-acting insulin, and Fiasp, which is their next generation ultra rapid-acting insulin. If you look first at the graph on the left-hand side here, this is the pharmacokinetic curve. Essentially what you're looking at here is the increase in insulin in the blood in a Type 1 diabetic patient after a single injection of either AT247 in the green, NovoRapid in the red or Fiasp in the blue. I'll talk about these results now in relation to Fiasp, as it was the fastest acting comparator within this study.

The first thing you'll notice here is there's a shift to the left of the curve for AT247 in the green. What this means is that we indeed saw an accelerated absorption of insulin, so insulin was appearing in the blood much faster. We also then saw a significant acceleration of the exposure, so the amount of insulin on board in the blood over time, and particularly in that first two hours. This is an important period where we've eaten food, our blood glucose has risen very rapidly, and we need that insulin on board as quickly as possible post-injection. We knew from our pharmacokinetic data that we'd achieved our goal of accelerating the absorption and getting more insulin on board. Then if you look on the right-hand side here, this is the pharmacodynamic data.

This is essentially the glucose lowering profile of the insulins. Again, what we saw here is that we've seen that increase in insulin exposure post-injection. This did indeed result in an increase, a significant increase in glucose lowering profile. We saw a greater and faster glucose lowering profile for AT247 when compared to both NovoRapid and Fiasp. The reason we're so excited about this data and where we see the most patient benefit for AT247, we've proven now against those gold standard insulins in the market, that it's a faster acting insulin, that it has a superior glucose lowering profile, and then really has the potential to enable really a transformational treatment option for Type 1 diabetics, which is called a fully closed loop artificial pancreas.

This is a system, as you can see on this slide here, where the patient wears a continuous blood glucose monitor. This monitors their blood glucose measurements at any point in time. These measurements are fed to a control algorithm, which calculates based on their blood glucose reading, how much insulin they need to maintain their blood glucose inside their healthy target range. This insulin dose is automatically administered via the insulin pump. This isn't sci-fi. These systems are available today and in use by patients in real world use, but they're called hybrid closed loop systems.

The reason that they're hybrid systems is that, the patient needs to come out of the system at mealtimes, announce that they're going to have a meal, and instruct the, insulin pump to administer to them a large dose or a bolus dose of insulin. The reason for this is, as I was explaining earlier, those gold standard insulins are still not fast enough acting, still don't respond quickly enough in real time to that swift rise in blood glucose to bring, the individual back into their healthy target range quickly enough. There's a real need here for these systems for a much faster acting insulin to enable the system to be used throughout the day and night, including at meal times. This is really considered the holy grail for people living with type one diabetes.

It's well demonstrated that the time that they spend within the closed loop system, that improves their time in range. It improves their time spent in their target blood glucose range and ultimately then improves their outcomes. There's real potential here for AT247 to enable this system. The study that's ongoing in the U.S. at the moment is delivery of AT247, comparing again with NovoRapid and Fiasp over once administered continuously over three days via an insulin pump. That will start to give us some data around the compatibility with the insulin pumps and the superiority again of the PK/PD profile is what we'll be looking to achieve there. That can lead to then a longer-term study where we can start measuring time in range, for example. Just moving on to AT278, just to explain the difference between the two products.

Again, we've taken existing insulin, and we've used the Arestat ™ technology in this case to develop a highly concentrated, so it's 500 units per ml, which is 5 times the concentration of standard insulins. In the AT247 study, AT247 is at 100 units per ml, as are all the comparators, there. We've used the technology to make this very rapid acting. The need here is that there is a growing number of people with diabetes, particularly Type 2 diabetics, who are requiring high daily doses of insulin to control their blood glucose. This really goes hand in hand with the obesity pandemic. Currently, there are no concentrated rapid-acting insulins available for this patient population. Essentially for them, currently they have two choices.

They can either select one of the gold standard rapid-acting or ultra rapid-acting insulins that are available to them today. This provides them with good blood glucose control, but it means that they have to administer their very high daily doses through high injection volumes, which can be uncomfortable and painful, and by multiple injections multiple times a day. Or they can select the only other concentrated insulin on the market, which is also at 500 units per ml, so the same concentration as AT278. This is a more intermediate-acting insulin, so it's a slower acting insulin. They get all the benefits of lower injection volume, fewer injections per day, however compromising on blood glucose control and hence ultimately outcomes. With AT278, what we're looking to achieve here is very concentrated but very rapid-acting insulin.

Essentially the patients then can have the best of both worlds. Lower injection volume, fewer injections a day, but not compromising on their blood glucose control and outcome. The challenge here essentially is as you concentrate our insulin, it becomes slower acting. We have been able to use our technology to overcome this, and we have a market leader position here. As far as we're aware, we're the only company, certainly clinically, that's demonstrated being able to achieve this sought after profile, this concentrated rapid-acting insulin profile. I'll just talk you through the results. These results are actually hot off the press. They were presented for the first time last Thursday at the Diabetes Conference here.

What we were looking to achieve here, we're looking at AT278 at 500 units per ml, comparing pharmacokinetics and pharmacodynamics compared with NovoRapid, which is Novo Nordisk rapid-acting insulin, which is at 100 units per ml. We've got a fivefold difference in concentration here. Again, what you're looking at on this slide is the pharmacokinetic data. This is the increase in insulin in the blood post a single injection to Type 1 diabetic patients. You'll notice here, what we were looking to achieve, what the primary endpoint for this study was, that it would be non-inferior to NovoRapid despite that increase in concentration. We met that primary endpoint and in fact some secondary endpoints in the study. You'll also notice there is again a shift to the left for AT278.

We not only achieved a non-inferiority, but we also achieved superiority in terms of that acceleration of absorption, so the onset of appearance of insulin in the blood and also the amount of insulin in the blood over time in that first 60 minutes. We saw a fourfold increase in insulin exposure, so four times more insulin on board in the first 30 minutes post-injection and 1.5 times more insulin on board in the first 60 minutes post-injection for AT278 versus NovoRapid. This really is a very exciting profile here, and as I mentioned, we have a market leader position as the first concentrated rapid-acting insulin. Then if we look at the pharmacodynamic data, so this is the glucose lowering profile. Again, we saw a faster onset of action of glucose lowering, so it started lowering blood glucose much more quickly.

We saw a very dramatic 9-fold increase in glucose lowering in the first 30 minutes and a 2-fold increase in the first 60 minutes. We know here that post-injection, you've eaten food, inject your insulin, and it starts bringing down that blood glucose much faster and to a much greater extent here. I'll just draw your attention to an event that's coming up actually at the end of this month, which you may be interested in attending. If you are, please do get in touch, and we'll make sure you receive the link. This is a key opinion leader event where Professor Thomas Pieber will be talking through the AT278 clinical data in much more detail than I have today.

We have a panel of world-leading experts within the diabetes space who will talk through the patient need for more concentrated rapid-acting insulin. As I say, I think it'll be really interesting and insightful event if anybody would like to join that. Just moving on here in terms of key upcoming milestones. As I mentioned for AT247, we're currently in the middle of a U.S. clinical study. This is a three-day insulin pump study, and we'd expect to be reporting headline results in the second half of 2022.

For AT278, on the back of our results, which were very much at the high end of our expectations, we're looking to initiate our next study here, and that would be looking at AT278 in a target patient population, so in the Type 2 diabetic patient population. I'm just going to hand over to Susan to talk through the financial highlights.

Susan Lowther
CFO, Arecor Therapeutics plc

Thank you, Sarah, and good morning, everyone. Arecor's admission to AIM occurred on the 3rd of June 2021. We raised new investment of GBP 20 million from existing and new shareholders. The proceeds raised are to progress our proprietary development pipeline. At admission, we had a share price of GBP 2.26 and a market cap of GBP 62.5 million. Our 2021 P&L shows that we have a commercial focus with total income of GBP 1.8 million derived from revenue and grant income. R&D investment increased to GBP 5.4 million in 2021, and we expect this to increase further in financial year 2022. Our R&D expenditure this year will include the U.S. phase I study for AT247, which is in progress, plus a second study for AT278 in the second half of this year.

Our cash at December 31 was GBP 18.3 million, compared to GBP 2.9 million in the prior year, and our balance sheet was further strengthened with the conversion of GBP 4.4 million of shareholder loan notes into ordinary shares at a 10% discount to the IPO price. Our key financials. We recognize revenue from our technology partnerships in two ways. Formulation development revenue is recognized as the projects are performed, and as you'll see, our 2021 recognition of GBP 1.2 million was up on the prior year. This included revenue recognized against five new technology partnership agreements signed in the year and agreements signed in prior years. Our formulation development projects represent future licensing opportunities. 2020 prior year revenue included the recognition of licenses and milestones which are periodic in nature.

Revenue is recognized at a point in time when a milestone is achieved or a license is granted. Our other income of GBP 0.6 million was derived from the Innovate UK Grant award in March 2021, and we have GBP 2.2 million of grant income to be received over the remaining project term. Our improved net assets position at the end of 2021 primarily reflect cash. We also have an R&D tax credit receivable of GBP 0.8 million and GBP 1.4 million receivables from formulation development projects. Our payables of GBP 2.1 million included accruals of GBP 1.2 million related to the U.S. clinical trial, which became cash outflows in early 2022. Back to you, Sarah.

Sarah Howell
CEO, Arecor Therapeutics plc

Thanks, Susan. Just to round off for today, hopefully, we've given you a good overview of Arecor, our platform technology, and also our partner programs and proprietary products. I think as you can see here, we met a number of really significant milestones in 2021, both clinically across our proprietary portfolio, obviously our successful AIM IPO raising GBP 20 million , and continued progression across our technology partnering portfolio. We're certainly taking that momentum into this year. Things to look out for really in 2022 would be the clinical results from our three-day insulin pump study for AT247, which we'll be reporting in the second half of this year. The initiation of that important Type 2 diabetes study for AT278. We'd expect to hit our next license milestone under our Hikma AT282 co-development and licensing agreement.

Also advanced that portfolio of specialty hospital products that Arecor is working on internally here, and we're looking to progress those and generating the data and the intellectual property to lead to more Hikma type licensing deals. We would certainly expect to see continued technology and partnering growth through the year as well. That concludes the presentation for today. Of course, we'll be happy to take any questions that you have.

Operator

Sarah, Susan, that's great. Thank you very much indeed for your presentation this morning. Ladies and gentlemen, please do continue to submit your questions just by using the Q&A tab that's situated in the right-hand corner of your screen. Just while Sarah and Susan take a few moments to review those questions submitted already, 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 your investor dashboard. Susan, Sarah, as you can see, we've received a number of pre-submitted questions as well as a number of questions that have been submitted during today's presentation. Firstly, can I thank all investors for submitting their questions.

Susan, Sarah, if I could please hand back to you just to read out those questions and give a response where it's appropriate to do so, and then I'll pick up from you at the end.

Sarah Howell
CEO, Arecor Therapeutics plc

Sure. No problem. Thank you, Jake. The first question that was submitted says, "Given Novo Nordisk's long-established market position in producing insulin, why is the pharmaceutical company not able to adjust the composition or formulation of its existing insulin products in order to improve the PK/PD profile. And following on from this, is any of the excipient or ingredient used by Arecor's AT278 or AT247 available only to Arecor?" I think in the first part of that question, Novo Nordisk have used a formulation approach to develop a second generation version of their insulin. Their first product on the market is NovoRapid, which is a rapid-acting insulin, and they have further developed Fiasp, which is a reformulation of NovoRapid, essentially to develop an ultra rapid-acting insulin version.

There's very much a drive from the major pharmaceutical companies and an understanding really of that need for patients, that they do need more faster-acting insulin, particularly those Type 1 diabetic patients that are looking to use artificial pancreas type systems. As you would have seen from our clinical data, that was a phase I clinical study, head-to-head with Novo's NovoRapid and Fiasp. We've been able to further and significantly improve on that profile to develop a faster-acting insulin with a greater glucose lowering profile compared to Fiasp there. I think, again, you see our insulin is that next generation moving towards more physiological insulin that acts more like a healthy person's response to an increase in blood glucose. In terms of those excipients, could they be used by others? The barrier to entry here essentially is Arecor's intellectual property.

We filed extensively protecting the formulations and the compositions of AT247 and AT278, as well as methods of use as well. As I mentioned, we had our first U.S. grant for one of those key patents protecting those formulations of AT247 and AT278. That would be the barrier to entry in preventing either Novo or Lilly or any biosimilar companies essentially copying Arecor's approach. The next question is how do the partnerships work with the likes of Eli Lilly. How are your partnership deals structured and what is the revenue profile. I'm assuming, I think this is referring to the technology partnerships. As you would have seen from the slides, we do have a partnership with Eli Lilly on one of their proprietary products.

These are structured in a way that there's a development program that's agreed with our partners, where we're applying the Arestat ™ technology to look to achieve a predefined target product profile. An enhanced profile that we've agreed with them. Our partner will pay Arecor to perform those studies. You've seen from Susan's slides and the headlines, financials, the kind of magnitude of those revenues to Arecor. On completion of the study, our partner then has the option to take a license to that formulation. That's a license to allow them to further develop and commercialize that novel combination of ingredients, as applied to their products, and also a license to the Arecor Arestat ™ intellectual property that they need then to further develop and commercialize that product.

They tend to be milestone and royalty-bearing agreements. To give you some sense of value, that's probably the follow-up question to this answer. For our proprietary programs where we're developing them, we're investing in those, we're developing those closer to market and generating those data packages, including clinical packages for our diabetes products. We'd expect those royalties to be in the mid-single digit to double digit range on commercial sales. For technology partnerships where Arecor isn't investing, of course, our own capital, we're applying our technology and our partners paying for those from day one. You're looking at more in the single digit range on the royalties there. Then of course, the absolute value of those depends on the market size of the product and our partner's success in capturing market share.

The next question is what do you believe differentiates Arecor from its competitors, especially in attracting new partnerships? I mean, I think the key here essentially is that our core USP is that we can use our innovative and proprietary Arestat ™ platform to deliver and develop enhanced versions of therapeutic products that are otherwise unachievable. So that really drives our partners to us because they would have always, these are large pharmaceutical companies, they would have always attempted to achieve that target product profile themselves. So they come to us when they're looking for a technology approach, something over and above standard approaches to formulation science essentially.

That's really what drives our licensing model, that under those partnerships, there's a recognition of the value that Arecor's bringing to the table, which then obviously converts into the upside potential of those milestone and royalty-bearing licenses. The next question is any major impact of the Cmax being slightly lower for AT than with NovoRapid? I think it's probably referring to AT278, there and actually for AT278 versus NovoRapid, there was no statistical relevance of differences of that Cmax. They are in fact very close and on those p-values very close on those on the statistical relevance. There's no clinical difference between the Cmaxes for those two products. Next is. Oh, I'll read out the compliments. "Great progress today." Thank you.

What near-term catalyst news flows can we expect and what do you see as the ongoing R&D costs?" I'll take the first half of that question, Susan, and then I'll hand over to you the second half. You know, I think in terms of near-term catalysts, here we have some clinical catalysts upcoming. Those results, clinical results from the current three days insulin pump study in the U.S. for AT247 will be a key catalyst. You know, that's in the patient population using the intended delivery mode, so delivered by continuous infusion and insulin pump there. We certainly see that as, you know, further validating the superiority of that product.

Clearly initiating our next clinical study in the Type 2 patient population for AT278 as well will be a milestone, then leading to a readout of those studies which will likely come outside of 2022 there. You know, across the portfolio I think we'd expect to see additional partnering growth in terms of both our current partners and products under license progressing closer to market, but also, you know, our technology partnerships with pharma moving towards those licensing stage and more technology partnerships coming on board through the year. I'll hand over to you, Susan, to talk about the ongoing R&D costs, please.

Susan Lowther
CFO, Arecor Therapeutics plc

Thank you, Sarah. In terms of our R&D cost for 2022, we do expect that to increase. As I said earlier, we're running costs of two studies in this year, and we expect that to probably reach double-digit GBP millions. On an ongoing basis we will certainly be in single digit GBP millions, and that figure will effectively flex depending on the timing of those clinical studies. Thank you.

Sarah Howell
CEO, Arecor Therapeutics plc

Thank you, Susan. I think that's the last question at the moment under the Q&A.

Operator

Absolutely.

Sarah Howell
CEO, Arecor Therapeutics plc

If anybody has any additional ones, we'd be happy to take those.

Operator

I will give it just a moment to see if there's any questions that come in. Okay, perfect. Sarah, Susan, thank you very much indeed for taking the time to address all of those questions that came through. Of course, if there are any further questions submitted today, we'll make these available to you, immediately after the presentation has ended. Ladies and gentlemen, we'll publish all those responses where it's appropriate to do so on the Investor Meet Company platform, and we'll notify you by email when these are ready for your review. Sarah, Susan, perhaps before redirecting investors to provide you with their feedback, which I know is particularly important to yourselves and the company, if I could just ask you for a few closing comments to wrap up with, that'd be great.

Sarah Howell
CEO, Arecor Therapeutics plc

Yeah, no. Thank you, Jake. Thank you everybody for, you know, taking the time to join us today. I think as you've seen, you know, as a company, we've evolved and, you know, being able to use that technology to develop these enhanced versions of therapeutic products, and I think we really do have the potential here to bring products to market with our partners that can transform patient outcomes and quality of life, which really is, you know, the purpose of Arecor. In doing so, we should be able to build a large and self-sustaining biopharmaceutical company, which is ultimately our strategic aim here. Yeah, thank you for taking the time and, we look forward to engaging with many of you in the future.

Susan Lowther
CFO, Arecor Therapeutics plc

Thank you.

Operator

Sarah, Susan, that's great and thank you very much indeed for updating investors today. Could I please ask investors not to close this session, as you'll now be automatically redirected for the opportunity 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 and I'm sure will be greatly valued by the company. On behalf of the management team of Arecor Therapeutics plc, we'd like to thank you for attending today's presentation. That now concludes today's session, so good morning to you all.

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