Arecor Therapeutics plc (AIM:AREC)
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Earnings Call: H1 2023

Sep 20, 2023

Operator

The company may not be in a position to answer every question it receives during the meeting itself. However, the company will review all questions submitted today and publish responses where it is appropriate to do so, and these will be available via your Investor Meet Company dashboard. Before we begin, I would like to submit the following poll, and I would now like to hand you over to CEO, Sarah Howell. Good afternoon, Sarah.

Sarah Howell
CEO, Arecor Therapeutics

Great. Thank you, and good afternoon, everybody. Thank you for joining us today. So, my name is Sarah Howell, I'm the CEO of Arecor, and I'm joined today by Susan Lowther, who's our CFO, and we'll talk you through today the interim results for the six months ending 30th of June, 2023. So I'll just draw your attention very briefly to our customary legal notice. So by way of background, at Arecor, for those of you that may be joining us for the first time today, we're very much focused on improving patient care by enhancing existing therapeutic medicines such that they're safer, more effective, and easier to use. And we do this by leveraging our innovative and proprietary formulation technology platform, Arestat, and we use this platform to develop these enhanced and differentiated versions of existing therapeutic medicines.

So during this slide, really what I want to talk you through is the vision for the business and how we see generating value and growth for the business. And our vision ultimately is to transform patient care by bringing these enhanced medicines, both ourselves and with partners, to market, and in doing so, building a large self-sustaining biopharmaceutical company. And if we really walk through those elements of the value generation here and the value build. So if we start on the left-hand side, this is our what we call our more early-stage pipeline. So this is a combination of early-stage R&D and our in-house proprietary products, and also our pre-licensed technology partnerships with pharmaceutical companies. So starting with our proprietary pipeline, we have an in-house proprietary portfolio of what we call specialty hospital products.

So these are products that are existing, that are already used within the hospital setting, but they're inconvenient to use in some way. We're very much focused on an area where these products are lyophilized powders that require a complex reconstitution or mixing procedure prior to use. We use the Arestat technology here to develop stable, liquid, ready-to-use or ready-to-administer versions of these products. So essentially, they're ready to go at point of care. Now, we're developing these products ourselves internally and, at the point of IPO, when Arecor IPO'd, in the middle of 2021, part of our use of proceeds there was to really build and initiate this platform. So we phased in products since that time, and we've been working on developing these ready-to-use formats of these products.

And we've made great progress there, so we have a number of products, those that we initiated earlier on in that life cycle, where we've applied the Arestat technology. We've been able to demonstrate that it's a good fit, and we can indeed enable these difficult-to-achieve, ready-to-use formats of these products. And we've been very busy filing IP there. And really moving forward then, as we develop those data packages and the IP, the upside potential comes through partnering here, and we'd be looking to enter into product licensing on a milestone and royalty-generating basis, very similar to the deal that we've already entered into for one of our specialty hospital products with Hikma Pharmaceuticals, and I'll talk about that later. So that really has the potential then to move assets from that pipeline up this value chain through into milestone and royalty-bearing partnering agreements.

On the technology partnerships, this is where pharmaceutical partners come to Arecor looking to achieve something special. They're essentially looking to achieve a differentiated product profile that they've not been able to achieve themselves internally. These are revenue-generating partnerships from day one. Our pharma partners will pay Arecor to perform that initial development work, so that's essentially us applying the Arestat technology to deliver these enhanced profiles. We will then develop a data package, which demonstrates that the target product profile has indeed been met. At that point, our partners have the opportunity to take that formulation and, importantly, a license to Arecor IP further forward into development and commercialization. This is under a technology licensing model, which again, tends to be milestone and royalty-bearing. Again, there's upside potential from these technology partnerships.

We've entered into three additional partnerships so far this year. The last partnership was with a top five global pharmaceutical company, and these would then have that future upside opportunity. And then as we move to the right here and up that value chain, we have our clinical development portfolio in the diabetes space. So we have two insulin-based products here. We're developing a very rapid-acting insulin, AT247, and a highly concentrated rapid-acting insulin, AT278, and I'll talk about these in a lot more detail later in the presentation. And again, here, we're able to use the Arestat technology platform, but here we're looking at improving clinical outcomes for patients. So we're looking at improving the clinical performance of these insulin products compared to the gold standard insulins that are available for patients today.

So here our strategy is to develop clinical data packages to prove the superiority of these insulins compared to those gold-standard insulins, to demonstrate the benefit to the patients, and also, of course, to drive then key data packages and valuable data packages to drive high-value partnering. Our strategy is to partner these for late-phase development and commercialization. We'd anticipate, given the clinical differentiation here in the market size, we're targeting greater than a $6 billion market, that any deal in these areas across our insulin portfolio would be transformational for Arecor. Then we have our licensed partnerships. We have three products under license. These are products that incorporate the Arestat technology and have been fully transferred to our partners, so the further development and commercialization of these products is completely under their control. However, they're under license agreements with Arecor.

Again, milestone and royalty base there. These really offer that with both near-term revenue generation potential from achievement of licensed milestones, and I'll talk about these in some more detail also. Then as we build towards that large self-sustaining company, as they come to market, offer more sustainable and predictable commercial revenue streams from royalties or equivalent there. We are anticipating the first product, AT220, to be on the market in the not-too-distant future. Again, I can talk a little bit more about some of the milestones around that product. Then from the commercial side of our business, many of you may know that we acquired a commercial company, Tetris Pharma, in August of last year, so we've just come past our first-year anniversary, and they're a sales, marketing, and distribution company for specialist hospital products.

The rationale for acquiring Tetris was twofold, essentially. First and foremost, they had license rights to a key product, Ogluo. This is a ready-to-use glucagon product. It's for the treatment of severe hypoglycemia in people with diabetes, so it's like the EpiPen for diabetes there. We saw a real patient need here for an easy-to-use, ready-to-use product in an emergency situation, in a patient population that we know well, as this is people with diabetes that are taking insulin. Also with Tetris, it offers us the optionality moving forward. If there are products within our portfolios, such as our specialty hospital portfolio, where it makes sense to take those to market ourselves in the UK and Europe, we can do so through our Tetris Pharma commercial arm there.

So it offers that optionality to retain more of the value as we're growing this large, self-sustaining business. And again, I'll talk about the progress of Tetris shortly, but we're seeing certainly sales growth across Ogluo there and confidence in that continued growth moving forward. And then as we move towards the licensed partnerships coming to market there, obviously, once they're on the market, that offers us more predictable and sustainable recurring revenue streams from those royalty-bearing license agreements that we have in place. So just looking very briefly at the portfolio, because I've, I've covered a number of these elements on the previous slide, and I'll talk in more detail around our proprietary portfolio and partnered programs here. So as I mentioned, we have a portfolio of de-risked and diversified in-house partner programs and also in-house proprietary programs, sorry, and also partnered programs.

So our strategy for our in-house proprietary products is to take those closer to market to generate the data packages, whether that be clinical in the case of diabetes or non-clinical in the case of our specialty hospital products, and take those closer to market to higher value inflection points, and then to partner on these to bring them to market. And as you can see in the diabetes space there, we'll be looking to gain market share with a partner in that existing $6.4 billion marketplace. I'll talk about our licensed partnerships shortly and some of the near-term and longer-term milestones that we have against those license agreements that are in place there. As I mentioned, the technology partnerships, these are pre-licensed, have that opportunity to move over to a milestone and revenue-generating technology license agreements. We've entered into three this year.

That brings us to a total of 11 since the IPO, and that really validates the strength and need of the technology. Xeris, with the Ogluo product there, we're seeing strong growth of Ogluo and those revenues representing now a significant proportion of the Tetris Pharma sales. Talking through the operational highlights. This includes highlights up to the end of June, but also some post-period events here. As I mentioned, what we've been really pleased to see is very significant progress across our licensed partnerships. These are fully in the control now of our partners. Obviously, we have close relationships with our partners here and follow the development of these products very closely, but they're fully funded and in the full control of our partners. Now, AT307 is a ready-to-use specialty hospital product.

It started its life as an in-house proprietary product at Arecor, and we subsequently licensed this to Hikma under a milestone, a royalty-bearing agreement. Earlier this year, Hikma took on full development and commercialization responsibility for this product, so this is now fully funded as well by Hikma Pharmaceuticals. And really importantly, very recently, they had a very positive pre-IND meeting with the FDA, and this confirmed that AT307 can be developed under the 505 regulatory pathway. And this is important because it's an abbreviated development pathway to market, so it de-risks the development of this product and gives that certainty of the development steps that need to be taken to file for approval there.

It's also important because we have assumed across our in-house proprietary portfolio of specialty hospital products, that they can also follow this 505(b)(2) pathway, and this is certainly validation of that assumption via the FDA. So further de-risks and strengthens the partnering package for that, pipeline of specialty hospital products that we have under development. Then for AT292, this is again, a product. It's a novel therapeutic in development by Inhibrx. We're a Californian biotech, listed on NASDAQ. They have initiated a registrational enabling clinical study for this product, so they anticipate this being the last clinical study required prior to them filing for approval of this product. And this also, incorporates the Arestat technology, and the next license milestone under this agreement is on first patient dose in this study. So we would anticipate this happening within 2023 there.

And also just to note, Inhibrx closed a $200 million private placing in August of this year, so last month, and this was to fully fund the development of this product, both this clinical study, and they're also going to initiate a further clinical study and a new indication. So this shows great progress for this product and getting much closer to market, again, under a license agreement with Arecor. And then, as I mentioned, the first product that we'd anticipate coming to market is AT220. We, this is biosimilar product. The partner at this stage is undisclosed, but we would be expecting them to gain regulatory approvals for this product in the coming months. Subsequent to that, there'd be commercial launch, which would lead to recurring royalty, royalty streams.

Of course, the timing of this and strategy around, the lead time between approval and launch, sits within the control of our partner. I think what's key here is, given the stage of development there, we would see this as low risk, with this coming to market. I've talked about the technology partnerships. In terms of the in-house, proprietary portfolio, again, I'll talk about this in much more detail. We're currently in the middle of a clinical study for AT278, and I'll talk about the details of that. We've presented our phase I clinical data in Type 1 diabetic patients earlier this year, during the summer at the American Diabetes Association. This is the leading diabetes congress, and it was very well received and generated a lot of interest there.

As I mentioned, we've made key development progress across our specialty hospital and portfolio. The next phase for us, for the most advanced of these assets, would be to move towards partnering there, which brings the upside of milestone and royalty-bearing agreements. For the Ogluo products on the commercial side of the business, we have launched Ogluo now in additional three EU territories in 2023. So we've launched in Austria, Norway and Denmark, and that's in addition to the UK and Germany, where we launched in 2022. So it's now available in five territories, and we've also entered into a commercialization agreement with Goodlife for the Benelux region, and our main target there would be the Netherlands. So we look forward to them launching, and we expect them to launch in the Netherlands in the H1 of 2024.

Finally, on IP, we continue to make great strides across our intellectual property portfolio. It's obviously core to our business in protecting the technology and also the proprietary products that we're developing using the technology. We have more than 75 granted patents now in major territories, and we've had five additional patent grants so far in 2023, including key patent grants across our diabetes portfolio, AT247 and AT278. Perhaps talking in a little bit more detail about our license partnerships. Firstly, talking about AT307, so our ready-to-use specialty hospital product with Hikma. As I mentioned, they took on full development rights earlier this year, and since they have made really great progress. They've had this positive meeting with the FDA, so that's the regulatory and development pathway confirmed.

And now, looking forward, there are additional license milestones in the near term under that license agreement with Hikma. And then ultimately, when this product comes to market, it would be under a royalty-bearing agreement. Now, we have talked previously a little bit about framing the value opportunities for these and for our in-house proprietary products, where we're taking the investment with filing the IP. It allows us to drive higher value licensing deals here, and Hikma certainly falls into that bracket there. So we look here for royalty percentages in the region of the mid-high single digit to double digit royalty streams off product sales, and Hikma certainly fits into that category there. So we're very much looking forward to the continued development from Hikma, and ultimately, we hope for a successful commercial launch of that product.

We see that as really driving value and, of course, recurring revenue streams to the Arecor business. And then just quickly on the other two partnerships, so AT220. This is important because we do expect this to be the first product that would come to market incorporating the technology. There is an additional license milestone payments under our license agreement with our partner prior to that recurring royalty revenue stream. And we will update the markets, of course, once this has been achieved, and then ultimately move forward into... which will give more clarity on the timeframe of that recurring royalty stream associated with that product. And then for AT292, as I mentioned, Inhibrx have initiated that registration-enabling clinical study, and the next license milestone payment to Arecor is on first patient dosing, which we expect this year.

Inhibrx have publicly announced they expect an initial readout from that study to occur in late 2024. So I think if they keep to those timelines, you'd be looking at 2025 there for submission for regulatory approval. So that product, again, is progressing now much closer to market. So to talk in a little bit more detail about our diabetes products. So, you know, diabetes is a pandemic, and, you know, we believe it will remain to be the case. There are around 537 million adults living with diabetes. And at Arecor, we're very much focused on a specific area here, of specific treatment, and this is around mealtime insulins. And we're looking to develop the fastest-acting and most highly concentrated, fastest-acting insulins.

This is to meet very specific unmet patient needs, and to really deliver improved treatment options for these patients. If we talk about the two products, our first product is AT247. We've taken existing insulin, we use the Arestat technology to reformulate this, and we're focused on accelerating the absorption post-injection, so that we have a faster-acting insulin that can bring down blood glucose for people with diabetes much faster. It's at the standard concentration that is used today, 100 units per ml. Really, the aim for AT247 is to be the fastest-acting insulin that can enable this transformational, fully closed-loop artificial pancreas system. I'll just spend a couple of minutes talking through what that is and what the challenges are here.

This system is a system where the individual will wear a continuous blood glucose monitor that measures their blood glucose at any point in time. This reading is then fed to an algorithm, which calculates, based on that blood glucose reading, how much insulin the individual needs to keep their blood glucose within their healthy target blood glucose range, which is automatically delivered via the insulin pump. Now, these systems are in use today. All of this hardware and technology is available, and available commercially, but they're called hybrid closed-loop systems. The reason it's hybrid is the challenge around mealtimes. Because when we eat food, our blood glucose rises very rapidly, and the fact is, even those best-in-class insulins, which are available for patients today, are not fast enough acting to counteract that very swift rise in blood glucose in real time.

So what this means is, around mealtimes, that the patient instructs the system to give them a large single dose or a bolus dose of insulin to manage their blood glucose around mealtimes. So really, with AT247, what we're looking for here is a much faster-acting insulin that can counteract that swift rise in blood glucose, even at mealtimes, and allow the patient to stay in this fully closed-loop system. So essentially, the system is controlling their blood glucose and doesn't need their intervention. So this really lowers the burden for patients, which shouldn't be underestimated. It's a significant burden, managing diabetes on a day-to-day basis. And it also, we've looked to improve the outcomes of the patients. We know that when they're in that closed-loop system, that their outcomes are improved.

We have. I've not got the data within this presentation, but I've presented it previously. We've conducted two phase I clinical studies for AT247, comparing against those gold-standard insulins today. So insulins from Novo Nordisk, which are rapid-acting and ultra rapid-acting, and we've been able to demonstrate superiority of AT247 so that we've demonstrated that we have indeed accelerated that absorption of insulin post-injection. Now, the second product that we have in development, insulin product, is AT278. So this is a very highly concentrated, rapid-acting insulin. So this is at 500 units per mL, so it's 5x the standard concentration of insulin that's used today. The reason that we're developing this product is that there are a growing number of people with diabetes who require high daily doses of insulin.

Now, a majority of these at the moment are Type 2 diabetics, with high BMIs, but we're seeing an increase in number of people with Type 1 diabetes who are requiring high daily doses of insulin, and this is linked to BMI, so linked to weight and obesity, which we're seeing rising significantly. There's not really a good insulin option available for these patients today. They have two options available to them, which both bring compromises. They can use one of the gold-standard rapid-acting and ultra rapid-acting insulins. This gives them good blood glucose control, albeit not as good as you would achieve with AT247, but they also require to inject high volumes of insulin and multiple injections multiple times a day, simply to get their high doses on board.

Or they can select the only very concentrated U-500, so it's 500 units per ml, same concentration as AT278 insulin. This is a product from Eli Lilly. It's called Humulin R U-500. So this gives them the benefit of reduced injection volume and fewer injections per day. However, it's an intermediate-acting insulin, so it's a slower-acting insulin, which means there's a compromise on blood glucose control, particularly around mealtimes there. So with AT278, we're basically saying that you can have the best of both worlds here. You can have lower injection volume, fewer injections a day, but no compromise on blood glucose control because it will be as fast-acting as those gold standard insulins that are available today.

And also with AT278, what we're really excited about is the future, and we very much see the future moving towards these very small, miniaturized, body-worn patch pumps for people with diabetes. So these are insulin pumps that will be worn on the body, that they wear for a longer period of time again. So these insulin pumps are available today. There are insulin patch pumps available for patients, but they're much larger than the image you're seeing on the screen today. And there's a real drive from the device companies, so the insulin pump companies, and they talk very publicly about this, around moving towards miniaturized devices and extended wear.

At the moment, the insulin pumps are used in three-day cycles, and they're talking about moving towards seven to 10-day wear and also making them as small as possible, because the size of these insulin pumps is a barrier to use for many patients. It's a particular barrier for Type 2 patients as well, because they generally need more insulin, so they need to have more insulin on board on their pumps, and they don't want to be wearing or carrying with them a large insulin pump. Again, those device companies see a transition of Type 2 patients over to insulin pump therapy is a very underpenetrated market. In the US, less than 5% of Type 2 diabetics currently use an insulin pump, so there's a significant opportunity there.

The key here is, if to enable a very small, longer-wear pump, it means you've got to get much more insulin on board in a much smaller volume. AT278 is the only highly concentrated, rapid-acting insulin in development. The reason it's the only product in development is this is a particularly difficult profile to achieve. We've achieved it with the Arestat technology, and we also have a really strong patent portfolio with protection out to 2037 for the techniques that we've used to deliver this product profile. In terms of clinical validation for AT278, we have performed one clinical study in Type 1 diabetic patients, where we compared AT278 to NovoRapid. NovoRapid is Novo Nordisk, 100 unit per mL insulin, and it's rapid-acting. It's on the market today.

AT278 is a 5x concentration here, but also rapid-acting. In that first clinical study, we showed that it was non-inferior to NovoRapid in Type 1 diabetic patients. In fact, we showed superiority in the first 60 minutes, so we got more insulin on board and a superior blood glucose lowering profile compared even to NovoRapid's 100 unit per mL insulin. Now, the current clinical study is really important because it's in Type 2 diabetic patients with high BMI. These are overweight and obese patients, so it's really the first primary target patient population that would really benefit from a profile such as AT278 here. We're comparing AT278 again against NovoRapid in this Type 2 patient population, but also importantly, against Eli Lilly's product, Humulin R U-500. It's against the two treatment options that is available for this patient population today.

What we would expect to see here is, against NovoRapid, that it's, despite that fivefold increase in concentration, that it's equivalent in terms of PK/PD profile here, and against Humulin R U-500, which has a slower profile, but it's superior there. So really demonstrating the benefits of this product. Oh, and I should say, we'd be looking to report headline data from this study in the first quarter of 2024. So just circling back to Tetris Pharma, and then I'll hand over to Susan to talk through the financials here. I mean, I've covered a lot of this, so Ogluo is now available in five territories across the UK and Europe.

We expect a further launch in the Netherlands in the H1 of 2024, and we're really seeing that growth of Ogluo, with it now representing a significant proportion of those Tetris sales, which really puts us in a good place to drive that continued growth and confidence in the growth of this product moving forward. You may all have also seen, if you're following us in our business update over the summer, that Shafiq, who's the current managing director of Tetris, will be leaving the business later this year, and we are in the process of interviewing a really high-quality shortlist of candidates for this leadership position at Tetris. Here, what we're really looking for is somebody with a proven track record of commercial sales of specialist products, such as Ogluo, across Europe as well as the UK.

I'm really pleased with the candidate shortlist that we have, and I'm sure in the not-too-distant future, we'll be able to announce who will be taking on the leadership of the Tetris business and driving that business moving forward. I'll just pass over to Susan now to talk through the financials. Thank you, Sarah.

Susan Lowther
CFO, Arecor Therapeutics

We are pleased to report that our revenue for H1 2023 has increased by over 140% to GBP 1.7 million, and this compares to the GBP 0.7 million that we recognized for the same period to 30 June 2022. Our other income from the Innovate UK grant also increased, and that resulted in total income of GBP 2.3 million, which was an increase of above 100% compared to the GBP 1.1 million we reported for H1 2022. Our investment in R&D of GBP 2.9 million was lower than the H1 2022 investment of GBP 4.8 million. This was as we expected, as our focus of expenditure in 2023 is on the ongoing clinical trial for AT278.

Last year's R&D costs included a US phase I clinical trial for AT247 and costs for AT278 ahead of initiating the current study. Our closing cash and short-term investments at 30 June was GBP 8.2 million, and post the period end, we received a GBP 1.3 million R&D tax credit from for R&D expenditure in the year ended 31 December 2022. Just exploring a little bit more of our key financial numbers. Certainly showing here the doubling of total income and also our revenue is growing as well as broadening across formulation development, milestone revenue, and pharmaceutical products. Just to say that the revenue from the two new formulation projects that were signed post-period, we announced one in July and one in August. Those revenues will be recognized from second half of this year onwards.

The Hikma milestone was triggered in January, and the pharmaceutical product sales represent the sales by Tetris Pharma, and we've compared those against H1 2022 pre-acquisition sales, which were just below GBP 600,000. The loss after tax reflected our planned lower R&D expenditure and increased SG&A costs, including Tetris Pharma, which were nil in the prior period. Just to say that the R&D carried out within our group is all carried out within our core, and the SG&A costs effectively represent everything that is not an R&D expenditure. Cash, in terms of net assets, cash and cash equivalents, were boosted post the period end with receipts of that R&D tax credit, but also the reimbursement of GBP 0.4 million of grant income for expenditure that we incurred in the H1 of the year.

Our trade receivables are GBP 4.7 million, and payables and accruals of GBP 6.3 million include Tetris Pharma, which were not part of our reporting in the prior period, ended 30 June 2022.

Sarah Howell
CEO, Arecor Therapeutics

Great, thanks, Susan. Just making sure I was on. Yeah, this is a really closer slide here to give a little bit of a recap of some of those milestones we've talked about and a bit of a longer-term view here. Hopefully, I think what you've seen through the presentation today is that we've made really significant progress across our in-house proprietary product portfolio, our partner portfolio, and also now commercial operations here. Across that partnered portfolio, of course, we have the Hikma Specialty Hospital product AT307. You know, moving across to their full control and development and investment here, that the FDA meeting there, and that confirmation of the 505(b)(2) platform, and very much commitment from Hikma now for the further development and ultimately, we hope, commercialization of that product, and that's under a milestone and royalty-bearing agreement.

You know, for AT220, we still expect very much so that to be the first product on the market incorporating technology. We have that near-term license milestone as well that's pre those recurring revenues, and then once on market, we move into that more predictable and reliable royalty generation streams there. And then within Inhibrx, AT292, we very much expect them to be dosing first patient within 2023, and then importantly, working through that clinical study to set them up for regulatory approval. Again, there are a series of license milestones prior to those commercial post-commercial streams, and then we can look to the future and see more products coming to market incorporating the technology.

We do have technology partnerships that are pre-licensed with pharmaceutical companies as well, that have that opportunity then, that generate revenue now, but also that opportunity and real upside potential from licensing. As I mentioned, for our specialty hospital portfolio, we've made great progress since we've been initiating those products. We're now in a strong position around filing IP, so we'll be looking as we go through the remainder of this year and certainly into 2024, at converting additional value-driving licensing, so Hikma-type deals with pharma. From the commercial operations side and revenue growth there, we see that continued growth. Sales of Ogluo really providing us a strong platform for growth commercially moving forward.

Then I think if we look through into 2024 and beyond, I mean, clearly for early 2024, we'll be very much looking forward to the clinical results from the AT278 trial. That's important to further drive discussions that we have with potential partners and also endocrinologists, and really, that pull and excitement around that product, which we are ourselves very excited about for all the reasons that we've talked through today, to continue to expand our in-house portfolio of products, to provide those opportunities and those license opportunities for the future.

Then with the anticipation of products coming to market, such as AT220, and then as we go towards 2025 and beyond, additional licensed products coming to market, and we start to see that build across multiple products, incorporating the technology then, and that build of recurring royalty and equivalent revenue streams, which really allows us to realize that vision of building a large, self-sustaining pharmaceutical company. So, this concludes the formal presentation for today, but, of course, happy to take any questions that have been submitted today.

Operator

Sarah, Susan, that's great. Thank you very much indeed for your presentation this afternoon. If I may just jump back in there, and what I'll do now is just bring back up your cameras. Ladies and gentlemen, please do continue to submit your questions just by using the Q&A tab that's situated on the top right-hand corner of your screen. But just while the team take a few moments to review those questions that were 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 have received a number of questions throughout your presentation this afternoon, and thank you to all of those on the call for taking the time to submit their questions.

Sarah, Susan, if I may just hand back to you, just to make your way through the questions, give your responses where it's appropriate to do so, and then I'll pick up from you at the end. Thank you.

Sarah Howell
CEO, Arecor Therapeutics

Great. Thank you. So I'll read out the questions, and then Susan and I will, we'll answer these between us. I think people know that have listened in before, we like to answer every question, where we can, so we'll just work through these one by one.

So the first question that was submitted is, "Your insulin programs look very exciting. How can you accelerate the potential here, given the size of the market?" You know, firstly, I would say we certainly agree with you in terms of, those insulin programs. You know, We now have clinical data across both products that really demonstrate their superiority, compared with those gold standard insulins here.

I think in terms of, you know, the size of the market, it's a greater than $6 billion market, and it's really, for us, about generating that clinical data that proves we're meeting that unmet patient need, which would then give us confidence, you know, with the right partner in gaining market share within that, you know, very large patient segment and also, you know, commercial market potential. In terms of the acceleration here, we, you know, in parallel to conducting these clinical studies, we're, of course, engaged with the regulatory, the major regulatory bodies, so that's the FDA and also the EMEA, so the European regulators as well. That's to approve our clinical studies, but also to discuss with them pathways and abbreviated pathways moving forward.

So we're confident here, as we're using existing insulin, and so the safety and effectiveness, the efficacy of insulin is known, that we can follow abbreviated pathways to market. The clinical data that we're generating effectively is to demonstrate that, we've got superiority. It's not to demonstrate that insulin itself works or is safe. That's already been demonstrated. So we're confident there there's abbreviated pathways, to market, and we're also confident that in the hands of Arecor, that we can conduct, as we've shown, you know, these key clinical studies, efficiently, quickly and generate this high-quality data. So I think the, the data from AT278 is obviously a key milestone. It's a key value driver and really starts to broaden out and, and significantly strengthen our package for either future studies or, or partnering.

The next question is, "Given the progress you're making and the validation through the number of partnerships, why is the company so undervalued, and what can be done?" I mean, I'll say a few words on this, and I'm sure Susan will have some thoughts as well. You know, what's within the company's control, and, you know, Susan and I and the leadership team here is delivering. I think what we've demonstrated, you know, certainly throughout our life as a public company, is that we're delivering the value and delivering what we have set out. We're very clear on the progress that we've been making, the value milestones within the company. You know, we would agree with that. You know, from the licensed partnerships, we partner very carefully.

So we partner with companies that are motivated to take the products incorporating our technology to market, that have the capabilities and the funding to do so, but it is fully in their control. And I think we can see that through the progress that's been made across those products. And, you know, we really look forward to seeing these products come to market. And I think they're, y ou know, once they're on market, it'll start to demonstrate as well, more publicly into the market, the, the value that can be generated and the recurring royalty streams within the business. I think then we look at, you know, what could be really transformational for the business, clearly, the diabetes products there and our insulin products. And again, you know, we've generated key clinical data, you know, demonstrating superiority.

We can see the markets very much moving towards, you know, a need, much greater need for things like AT278, with the device companies moving towards patch pumps and longer wear and miniaturization. We know there's very much patient need there. Again, what's within our control is to conduct the right clinical studies. We take very careful advice on the design of those studies and the data generated from those. And I think, you know, we would hope that the results from AT278, you know, would be valued and that we'll see the value of those. You know, then in terms of company value and on market, the markets are difficult, as everyone knows at the moment.

I think the performance of Arecor shares and stocks is not outside of normal market conditions at the moment for biotech companies. But, Susan, you might want to comment a bit further on that.

Susan Lowther
CFO, Arecor Therapeutics

I would just re-echo what you've already said, Sarah, that it's a challenging environment and what we can influence and focus on is setting out very clearly, as we did at our IPO, our vision for the company and those value inflection points that we are looking to achieve. And continue to report and to do presentations like this, to actually communicate the progress that we are making, as part of that strategy, and hopefully, that will then demonstrate why we value the company. And so, that will then hopefully be reflected in our share price.

Sarah Howell
CEO, Arecor Therapeutics

Thanks, Susan. Next question, "Can you expand on the outcome from the recent FDA meeting and ideas on next steps, timings, et cetera?" This is around AT307, which is the ready-to-use specialty hospital product that we've licensed to Hikma. I think the main aim and the main outcome from the FDA meeting there, which Hikma was the sponsor of, was to confirm that regulatory pathway. We've had this assumption, which was shared by Hikma, that this product could follow the abbreviated 505(b)(2) pathway to market, but ultimately, you need the validation of that from the FDA, and they got that very clearly. You know that in terms of understanding now the next steps and de-risking that program is significant. You know, in terms of time.

So the next steps, you know, really for Hikma, which they are conducting, is around manufacturing, scale-up, generating the data that's required under that 505 pathway, which again, is very clear. You know, we would anticipate this is our. I'm going to give you our estimations now, rather than Hikma's. We would anticipate there, under that 505 pathway, that Hikma could bring this product to market in the 2025-2026 time range. That's under a royalty-bearing agreement for Arecor, and that does fit in that as we, you know, anticipate the investment that we've made in our proprietary pipeline, that fits in that high single-digit to double-digit % royalties on sales there. So, you know, that would be a significant value driver and milestone for Arecor.

And the next question is, "What value proposition can AT247 potentially deliver?"

So, you know, AT247 is our ultra-rapid acting, so very fast-acting insulin here. So I think as we talked through the presentation, this is really a product that brings the most benefits to Type 1 diabetic patients who need that very precise control. And really, there's a real patient pull and drive around a really tight control of blood glucose, but clearly the burden of the disease. So there's, again, very much a pull and a drive towards simplifying the management of diabetes whilst improving outcomes. And, you know, to enable this Artificial pancreas system, so this closed-loop system, would be a huge development towards that step.

It reduces the burden, it takes the day-to-day interaction and decision-making out of the hands of the individual, so they can essentially, you know, fit their pump and as much as they can forget about, their disease while really maintaining excellent blood glucose control and improving their outcomes. As I said, there isn't an insulin on the market today that can close that loop. And with the data that we have for AT247 showing that superiority, there's a real opportunity there that it can, enable and be that ideal pump insulin, essentially, for that patient population. So the next question is, What contacts, if any, have you had with Novo Nordisk and Eli Lilly regarding your insulin products? Are they interested in providing funding to Arecor? So it's a good question.

You know, we have very close relationships with many pharma companies, as you know from our technology partnering business. I mean, it's in the public domain that we're actually partnered with Lilly on one of their proprietary products as well. So we have a close relationship with them. And I would add, you know, Sanofi also would be the third major pharmaceutical company that have mealtime insulins on the market. So, you know, have a high interest in this space. So we have very close relationships with all of those companies, and in addition, the biosimilar companies and also the device companies as well. There are lots of different ways that these products can be brought to market and different types of partnerships here.

And you know, what I would say about the major, the Novo, Lilly, and Sanofi, is that we do talk to them about the target profiles, the patient needs. We share many leading KOLs that advise us as well as Novo, Lilly, and Sanofi as well. And we're, we're very clear on, you know, targeting and working with those top-tier KOLs. And, you know, Novo and Lilly and Sanofi have all been very generous, actually, I think, in their time and their interaction with us in advising around clinical study designs, the data they would expect to see, because ultimately they're motivated to see improved products that they would then have an opportunity, potentially in the future, to be the partner that can bring them to market. So they want to make sure that the data packages would meet their needs there.

So I'd say, yes, we have very close relationships with them. We haven't approached them for funding, on that question there. You know, there's pros and cons of taking funding from a strategic partner, of course, and at this stage, we, you know, we believe we're building significant competitive tension across those groups, and we want to be able to be free, essentially, to, you know, to drive the best partnering deal for us moving forward and not be tied early to a single partner. So the next question is, When do you anticipate having to return to the market to raise additional capital? So I'm going to give you a high-level answer, and then I'm going to hand over to Susan for the detail.

You know, from a high level, in terms of strategy moving forward, you know, we're sufficiently funded to deliver on the key and drive the key value milestones within the business that we've talked about today. So, you know, in terms of driving that value through our existing portfolio, completing planned clinical studies, et cetera, there. So if we were to raise additional capital, it would be growth capital. It would be to look to expand our internal proprietary portfolio to ensure that we have a, you know, constant stream of opportunities at various stages of development that we can bring through and ultimately then increase the number of products that can be brought through to the market and, and drive value for the business. So it very much be a strategy around growth.

Susan, you might want to add a little bit more color on that in terms of cash runway, et cetera.

Susan Lowther
CFO, Arecor Therapeutics

Yeah, I can talk about that as part of our management of working capital. And what I would say is that our post, the period end, as you see, we actually received our GBP 1.7 million of additional receipts, and so our closing cash balance at the end of June has been increased post-period end. In terms of managing our working capital, we manage cash very carefully. Our cash flow forecasts include existing cash resources plus forecast receivables, and we use those to support planned target expenditure, including R&D. Our forecasts from a cash flow perspective only assume receivables from our existing contract, and therefore new deals, and you've heard about new deals that we signed in the H1 of those of this year. Those are an upside to our working capital management and modeling.

As you would expect, we model downside scenarios, and they are really more around the timing of receivables, balanced with the expenditure that we plan to make. In those downside scenarios, our cash flow forecasts extend to at least 12-month period from the date of the approval of these consolidated, unaudited accounts. As you will see in our interim statements, we've prepared our accounts and continue to prepare them on a going concern basis.

Sarah Howell
CEO, Arecor Therapeutics

Thanks, Susan. So, the next question, changing tack slightly here. When Tetris was acquired, was the need to change the CEO anticipated? So, you know, I think there, you know, we're really pleased. Firstly, I would say really pleased with the progress of Tetris Pharma and, you know, really the focus on Ogluo and the growth of that product. So, you know, there's no issues there. You know, I think in terms of the, the current MD, Shafiq, he's the founder-entrepreneur of that business, and I don't think it's unusual to see as the business transition, now it's really around a commercial focus and operational and tactical delivery of the business to, to see the founder CEOs move on there. So it's, it's all been in very close collaboration or very amicable, there.

And I think moving forward for, for Arecor, it really gives us that opportunity to hone in on that really specific expertise across the UK, but Europe as well. Tetris, very previously UK-focused business across Europe, so that we can really maximize and realize the full potential of Ogluo product. So the next question is, How does the technology partnership service get promoted there? So, you know, this is where we are partnering with pharmaceutical companies, and they are coming to us with their own proprietary products there. So this is a really combination now. You know, Arecor has a, you know, a, a much high profile in the, in the industry. We're well-known. It's well-known that we are able to deliver profiles that, you know, our large pharma partners have not been able to achieve themselves.

A number of our current partnerships are with companies we've worked with previously, so they're coming back to us with additional products within their portfolio, which I think again, demonstrates the reputation that we have, but also that we do deliver on these enhanced profiles that they're looking for there. We do have a business development group. We brought Manjit in in April of this year as CBO. You know, his primary focus is around our in-house proprietary products and the value propositions around those, and positioning those for partnering moving forward. He also talks with those, the very same large pharma companies that we're talking to about our in-house proprietary products are also potential partners for us with-... across their proprietary pipeline. There's a really good cross-flow, and cross-sell, if you like, across that side of the business, but it's really driven now.

We find pharma companies coming to us rather than the outreach from Arecor. So the next question, Susan, will be for you. "There was no Ogluo earn-out payment. Does that mean that sales have taken off slower than anticipated?"

Susan Lowther
CFO, Arecor Therapeutics

Okay. So the targets were proposed by the ex-Tetris Pharma shareholders. They were the sellers, and it was the greatest part of a contingent consideration at the time of the acquisition, and the targets reflected the seller's view, their experience, and their assumptions. And so the earn-out was not triggered in the first period. That does not mean that sales haven't taken off or are slower than we anticipate. As you've heard today in this presentation, the performance of Tetris Pharma post-acquisition is in line with our expectations.

Sarah Howell
CEO, Arecor Therapeutics

Thanks, Susan. So the next question is, "A company such as Scancell has taken on board a major industry-relevant US investor. They seem to have much deeper pockets and know-how than UK investors. Is Arecor talking to such investors?" You know, I think there, obviously, you know, Arecor, again, we spend our time networking with both pharma partners, industry experts, and, you know, the investor community is part of that. We do a large proportion of our business, our partnering businesses in the US, so we spend, you know, a reasonable amount of time out in the US as well there. I mean, clearly, you know, for US investors, there are a larger number of healthcare specialist investors in the US. They would look to come in on a capital raise.

You know, I don't think we'd anticipate US investors buying small volumes on market, but certainly moving forward as we move through our value propositions, if there were to be a more significant capital raise, we would look there to diversify the, the share register and our investor base as well. I don't know, Susan, if you want to add anything to that.

Susan Lowther
CFO, Arecor Therapeutics

No, I think that was good. I think that covers everything.

Sarah Howell
CEO, Arecor Therapeutics

So the next question, and potentially the last. So this is the last question, so if anybody's got a question, please do add it in. So it's a follow-up question to the cash flow question. "So you have a 12-month cash runway and will need to raise money before next June." I think maybe I'll start with a high level again, answer this. You know, and I think, you know, certainly on this, we our cash runway, you know, goes out into 2025, and that's based on contracted existing partnerships. So we incorporate into, you know, our operational forecast. We incorporate already converted partnerships, whether that be technology partnerships with pharma or our licensed partnerships there.

So I think as we've talked about today, in addition to that, there is the upside potential from additional licensing, whether that be from technology partnerships, converting our specialty hospital portfolio, and then, of course, anything around the diabetes would be transformational. So, you know, for us, you know, a raise in the nearer term would be around growth. Susan?

Susan Lowther
CFO, Arecor Therapeutics

Okay. Yeah, and just to clarify, thank you, John. Thank you for raising the question if I wasn't clear, because that, as Sarah has just said, what I was talking about was very much looking at downside scenarios as part of going concern. And as you may be aware, when you're doing going concern analysis as part of releasing your accounts, there's a lot of sensitivity and a lot of variables that you put in. And actually, so we're not talking about. I was not talking about cash runway. I was talking about actually, the statements are prepared on a going concern basis, and we've been through that rigorous going concern analysis. So thank you for clarifying.

Operator

Sarah, Susan, if I may just jump back in there. Thank you very much indeed for being so generous with your time then, addressing every single question that came in from investors this afternoon. And of course, if there are any further questions that do come through, we'll make these available to you immediately after the presentation has ended, just for you to review, to then add any additional responses, of course, where it's appropriate to do so, and we'll publish all those responses out on the Investor Meet Company platform. But Sarah, perhaps before really just looking to redirect those on the call, to provide you with their feedback, which I know is particularly important to yourself and the company, if I could please just ask you for a few closing comments just to wrap up with, that'd be great.

Sarah Howell
CEO, Arecor Therapeutics

Yes. So I mean, firstly, thank you to everybody online today for your time and for the questions. I think it's always great to have a significant number of questions as well, which helps us really get into the areas that we know you're all interested in hearing more. So thank you for that. And, you know, I hope what we've been able to show you today is, as I said, that significant progress the company's making across our de-risk portfolio of both in-house proprietary assets. You know, we're really pleased with the progress across our partnered programs there and that future now, which is becoming much nearer term potential for products on market, incorporating the technology and also across that commercial operations of the business.

So we think this provides us with a really robust platform for growth, and this is around bringing, as we said, improved products to patients that can really make a difference. That's the core purpose for Arecor. But in doing so, you know, really building a large self-sustaining biopharma company. So yeah, thanks, everybody, for your time today. We appreciate it.

Operator

That's great. Sarah, Susan, thank you once again for updating investors this afternoon. 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, but I'm sure will be greatly valued by the company. On behalf of the management team of Arecor Therapeutics PLC, we would like to thank you for attending today's presentation. That now concludes today's session, so good afternoon to you all.

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