IRLAB Therapeutics AB (publ)

Welcome to this live Q2 presentation by research company iLab addressing Parkinson and other CNS diseases. Presenting today is CEO Kristina Torfgård, Vice President Research and Development Niklas Waters and CFO Victor Sievert. After the presentation there will be a Q&A with equity analysts and viewers can ask their questions in the live chat. I hereby welcome CEO Kristina Torfgård and please go ahead with your presentation.

Thank you very much, Mattias. So this is our disclaimer and we are listed on Nasdaq Stockholm main market to remind about that. Very pleased to have you all listening in today. Can I have the first slide there? Thank you. Which is the agenda for today. So I will start with some news during the period. Hand over to Nicolas, EVP, head of R&D, to take you through the R&D update. And after that, we will hear Victor Sievers, our CFO, to take you through the financials. And then I will come back in there and talk and make some concluding words. And this will be then followed by a Q&A session, as you already heard. So we have had a very good period also this time. We are very excited about the progress we are doing with the projects. First here, I have summarized a couple of the key highlights that we think are very important for the company during the period and after. We have a new patent granted for Mestopetan, which is the SALT patent, which is used for the drug product for the candidates that we are developing and using in the studies. This patent will be extended until and through mid And this is specifically in the US, which makes that we have a really good impact in a huge market. And this is already granted in many of the other countries all over the world. So this will also strengthen our value proposition for the candidate. And we believe that this is also very important to bring in the ongoing discussions that we have regarding a partnership regarding Mestoputan. For 757 that we are developing together with MSR Jyotsuka, we were very pleased to see the data that we received from the repeated use study that we did in Healthy Volunteers. And we have already made the decision to continue into a study with individuals with Parkinson's and apathy. And we strengthened this, so we have progressed according to the plan. And we have to remind you that the program is fully financed by MSNRD and Otsuka through the proof of concept. Earlier this year, we presented data from our cortical enhancers, which is Peripamat 757 and 942 at an international conference, which is called Alzheimer's disease and Parkinson's disease. And there were huge interest about our cortical enhancers. And we really believe that we have groundbreaking data here for the candidates. And we will talk more about specifically Puripima there. And there we have the potential also for a new class of CNS drugs coming up. And then finally, during summer, we performed the right issue, which we were very pleased with the outcome from that. So in total, 150.5 million Swedish crowns we received before issue cost and the set of loans. And in total, we received around 60 million Swedish crowns in the company. This definitely strengthened our financial situation and also this is important in our ongoing discussions with potential partners to show that we have financing through I would say second half until second half of 2026. But also, we secured money for financing also two of our key projects, which is for Peripema to move forward with a couple of activities there, which we'll talk more about, and also for 11.17, that we are performing additional activities in manufacturing, I would say, substance for coming studies. So by that, I think it's time to hand over to Nicolas to take you through the R&D session.

Thank you, Kristina, and thank you all for listening today. Can I have the next slide, please? We'll start with a few words around Mesto på tam, and some very important progress in that program. Next, please. As you all remember, Mesto på tam is our most advanced project right now, and we have been working quite hard during the first half of this year in a kind of a boring aspect of it. It's de-risking the program. It sounds boring, but it means that we have ticked off a number of very important aspects for bringing this into the next step. Mestoputam, as we have talked about before, is a drug that has the potential to be an add-on on levodopa and to treat dyskinesia in Parkinson's disease. This is a problem for about 30% of all patients across the globe. It acts through inhibition of dopamine D3 receptors, today a recognized mechanism for treating dyskinesia. And we, as Kristina alluded to, we have developed the patent portfolio around the compound, and now we see that we could probably expect composition of matter-based exclusivity for the product in all the major markets across the globe towards the mid-40s. Next, please. At the Q1 presentation, we discussed the regulatory alignment that we have reached with the programme, and this is, of course, one of the most important aspects of the programme. That is that the regulatory agencies, both in the US and in EU, and across European local agencies, agree on the design of the programme, the endpoint structure of the programme, the additional studies that we should do in parallel with the phase three efficacy trials. So that's a very important de-risking aspect of the programme. And then there are a couple of other aspects of a program which are necessary for the value proposition. And as the foundation for any project of this kind, the protection, the exclusivity based on patents is an important, is perhaps the most important aspect. It defines the potential value of the program. And we have been very, very successful in developing a patent portfolio around Mestopetam. And the last pieces of this puzzle came in during Q2 this year with the granting of the SALT patent for, or actually a composition of matter patent for Mestopetam. It's SALT form, but also aspects of its production. This patent has been granted in all major markets across the globe, including China, Europe, South American countries, US, Canada, et cetera. And this means that we have exclusivity based on compositional matter, which is the strongest type of exclusivity and protection on the market. For this product, And depending on how we decide to use the granted patent term extensions, PTEs, we can see exclusivity to 43, 44, roughly, with the program. And this is an important aspect for the calculation of the, let's call it net present value of the program. Next, please. Another aspect which we have spent a lot of effort exploring, and that is the payer research that we've done for the product, both in the US and in the EU. And this work has led to the conclusion that payers see Mestopitan as something that could be used in the phase between adjustments of levodopa dosing which is the first thing you do when you see the occurrence of dyskinesia you usually start lowering the doses of levodopa or dividing the doses into more fractions during the day to keep a steady plasma concentration of levodopa that works to some extent for a while but eventually 30 And in some cases, even 40% of all patients actually get into dyskinesias, which are uncontrollable. And in those cases, you have to lower the dose of levodopa quite dramatically, which hampers the therapeutic effect. So what we see here is adding mestopatone will still allow for high doses or relatively high doses of levodopa without the complications, without the dyskinesias. And the positioning will be after these manipulations with levodopa and before going into the more expensive invasive treatments that are available for the late stage patients. And these late stage treatments are quite expensive. which means that we could actually get the premium pricing for Mestopiton, both in the US and Europe, according to the payer research we have done so far. And this is really interesting. And that also adds to the value proposition for the product. Next, please. PIR-Permat, a very interesting story around this program. We are the first company in the world, as far as we can see, to seriously address one of the biggest problems in Parkinson's. That is the mid to late stage occurrence of falling in these patients. So Piripimat is intended to treat falls, reduce the risk of falling, and we have taken this program from preclinical discovery all the way through a Phase II program, including a Phase IIb study, which we published earlier this year. Next, please. This is a first-in-class compound, exactly like Mestopatam, a first-in-class defining a new CNS class. acts through inhibition of alpha 2 receptors and serotonin 7 receptors and also here we have built a very strong patent portfolio with exclusivity reaching into the mid 2040s from where we stand today next please Falling is, as I said, one of the biggest problems. There is no treatment for it. There's lots of patients, about 45% of all patients fall recurrently. In the trials that we have conducted, if you go to the next slide, in the trials that we have explored, these are high fallers, patients that fall more than two to four times a month, actually. The cost of falling is huge. In general, if one looks at the cost of falling across the globe, and with a focus on the US, for instance, they spend roughly $80 billion a year for treating injuries related to falls. So this is the biggest problem also, not only in Parkinson's, but in elderly in general. What we saw in the Phase 2b study was, we've been through this before, we talked about it in the Q1 report, we see a clear efficacy with the drug. We reduced the falls in these high fallers with around 50%, which is highly clinically meaningful and really, really an interesting therapeutic effect of the drug. What we noticed in the trial is that this occurs in a specific plasma concentration range. And that is what we are now looking forward to. The next step for this program is to build the development strategy or development plan so that we can build in this finding into the development plan. And I'll come back to that issue a little bit later. uh so uh the plan is in place uh we are now preparing for the decision the internal decision to move forward to the next step and what we need to do is to produce some more mat of course but also to set the scene for this specific a specific trial intending to prove the the finding we got in the exploratory phase two studies. And that is to titrate patients into this perfect plasma concentration range and see the effect there. And that will be used then for the dosing strategy in the phase three program. The results that were generated in the phase two studies, phase two A, phase two B studies, has been extremely informative in terms of how we want to move forward. And that's the key with phase two studies. Another aspect of the programme, just as for Mestopaton, we are of course working hard with the patents and exclusivity for the programme. And the last puzzle basically in this game came in during the period. we have received a notice of allowance, which in principle means 100% likelihood of getting a granted patent also in Canada, which means that we now have exclusivity into the mid-40s for Piripimat as well. So that's 20 years from now. And this, of course, creates a huge value for the program. Another aspect of the programme is that during discussions with the physicians that participated in the trial after the trial, there has been a huge interest in being part of the writing committee for the publication. So we have now put together a pan-European expert group of Parkinson physicians, Parkinson doctors, uh to prepare the publication based on the face-to-be study and this is also an important puzzle in the business development activities that we are initiating now with the with this program next please 757, our successful phase one program. We have now decided to move this into patient studies, but we'll come back to that next slide. So this is also a novel first-in-class compound. We are focusing this towards neuropsychiatric aspects of Parkinson's disease, and we are looking initially at apathy. and we have designed a large study which will address that problem. This is an issue which is current in basically all neuropsychiatric disorders, with Parkinson's and Alzheimer's and other neurodegenerative disorders, of course. Between 20 and 90 percent of all patients in these populations experience apathy from time to time or persistently. With 757, we are addressing one of the hypotheses around the occurrence of apathy. That is the lack of connectivity between cortical and subcortical regions. The drug actually increases that activity in the brain. Next, please. During Q1, we have completed the phase one program, which was to a large extent funded by Michael J. Fox Foundation. And we are extremely grateful for that. That is a very, very fruitful collaboration, helping us to get this drug through phase one. On top of that, we also have this collaboration with MSRD, which is a branch of Otsuka. which will fund all the other activities. And the funding from Otsuka amounts to around 25 million dollars roughly during the course of the development of the program through the next trial. So the decisions that have been made during the quarter is that we have successfully completed all the preclinical safety toxicology and phase one activities needed to make a decision to go to the next step. So we have put together during the summer, when you're out swimming and bathing in the warm summer here in Sweden, we put together the file for application and that file is finalized. And we expect it to be submitted any day, today or tomorrow, actually, at IMA. And this is going to be a quite large study for the indication. We are planning for a 90-patient study, placebo, two different doses of 757. And this is an exploratory study where we are collecting a lot of information on various aspects, neuropsychiatric aspects, motor function aspects in this trial. With the data coming out from that trial will be the foundation for decisions to move this to the next step. But also during that period, Otsuka has the right to license the program. So there will be licensed discussions after the Phase 1b-2a study that we are conducting. Next, please. Preclinical programmes, we have two of those, 942 and 1117. Next, please. 942 is intended for cognitive deficits in Parkinson's disease and other neurological disorders. This is a huge problem. There are very few alternatives to treat cognitive deficits today. in this population and we think that 942 has a profile which is ideal for for parkinson patients new alzheimer patients and other patients with neurodegenerative disorders there's a quite large population available on the market about six million people have this complication For 1117, this is a really interesting program where we are looking at next generation treatment for the basic symptoms of Parkinson's. But next slide, please. We'll talk a few more words about 942. So this is a huge cognitive deficit. It's a huge unmet need, basically, in this population. About 12% of all adults over 65 have this problem. And 942... has a very broad efficacy profile across different modalities of cognitive deficits. And with this program, we see potential for both symptomatic and actually disease modification. Next, please. During the course of the first half this year, we have finalized the methodology for large-scale synthesis of the product. We have also produced API drug substance for the further studies. The studies that we are planning now are the IND enabling or the preclinical studies necessary for getting into phase one. And we expect to hopefully start those studies next fall and that is due to priorities in our in our pipeline and i'll come to that priority next slide please and we are between these two we are prioritizing the development of 1117 right now and this is a totally new strategy to treat the the basic symptoms of parkinson's disease the symptoms today treated with levodopa so about 85 to 95% of all diagnosed patients in the world get treatments with levodopa today. And 1117 acts on the same type of mechanisms like levodopa, but does not induce the complications seen by levodopa and is going to be a once daily treatment instead of up to six, eight times daily treatment. So what we've done during the course of the second half of the first half of this year, and we'll continue with that the second half of this year, that is to develop the large scale synthesis. This is, I wouldn't say complicated, but a very specific method to synthesize the compound. And this is a highly potent compound. So it needs specific sites to do that. And we are developing the API right now. And we are doing the preparations now for the regulatory studies to start phase one, which could be done during the course of next year, getting to phase one. Next, please. Sorry, go back one. One very important development during the course of the period, I should have mentioned that, we have done a series of preclinical long-term studies with 1117 addressing different aspects. And one specific aspect is the early discovery that we could treat uh in the preclinical molds we we can treat animals and we can see that you have a sustainable long-term effect on motor function improvements without the complications if we do parallel studies with when we do parallel studies we live dope i should say we see some efficacy but we also see the complications so the question we have tried to ask right now in the most recent study was why does 1117 not induce the complications? Why is it free of the complications? And that is to some extent revealed by this study that we are now going to publish during the course of the coming year, where we see that levodopa has a therapeutic effect but that is concomitant with complications and activation of certain genes in the basal ganglia, specifically two genes that are activated. And they are linked to the complications, fluctuations, dyskinesias and dyskinesias. 1117 does not induce these genes. That is really a key finding explaining the profile of 1117, the benefits of 1117. That was a fantastic study for us. We will publish this data in detail. Next, please, will be the finance report. handing over to Victor to actually finalize his work here at IRLAB with the last presentation of our finances.