IRLAB Therapeutics AB (publ)

In today's broadcast with research company iLab focusing on the Parkinson's disease, we will get a presentation of the second quarter of 2024, followed by Q&A with equity analysts covering the company. Viewers can ask their questions in the live chat and I will raise as many of them as I can. With that, I greet CEO Gunnar Olsson, Executive Vice President Research and Development Niklas Waters and CFO Viktor Sivic. Gunnar, before we start, what is your overall impression of the second quarter?

We've had a great second quarter with several very good advances in our portfolio. So it is a pleasure for me to be here with the team to present the second quarter outcomes to you. If we go to the slide, yeah, and if we take the next one. And the next one. So today's agenda, I will give you the highlights and news in the period And this would be followed by Nicolas Wotter to give us an update on the R&D progress. Victor Sievert will then take on and give an update on the financials. And I would come back to give some concluding words before we open up the Q&A session. So, next slide, please. The positive development in the beginning of the year has continued in the second quarter, as I mentioned, and we've had several important advances. Here, four of the key highlights for the quarter. With 757, we entered clinical studies. The first phase one study was initiated, and this is the study that is funded by the Michael J. Fox Foundation grant. And that means that we now have three compounds in clinical testing in Irlab. We came into a collaboration agreement with MSRD, a company in the Otsuka group. And that means that we are now aiming to take this compound all the way through to clinical proof of concept. And this means that this Compound is now fully financed all the way through clinical proof of concept. For Piritmat, we have the DSMB for the REACT-PD study. That is our face-to-be study. We have the second or the DSMB have their second and final review to look for data integrity and safety in the study. and the unanimous response and recommendation to us in the company, that is to just continue the study to completion. So that is very positive. And finally, on this slide, the board appointed Kristina Torfgaard as a new CEO for Irlab. And we are welcoming Kristina in her new role 1st of August this year. Next slide, please. Some words about the development collaboration with MSRD and Utsuka. The scope of this agreement that is to take 757 all the way through clinical proof of concept for the treatment of apathy in two populations, individuals with Parkinson's and individuals with Alzheimer's disease. And secondly, this as I mentioned, it secures all financing through clinical proof of concept for this compound. For Irilab, this means that we have received an upfront payment on three million US dollars, and there are activity-based milestones of five and a half million US dollars. Irilab will execute all the development activities And Irlab will also retain the ownership and all IP rights to the product. For MSRD, in addition to paying upfront and milestones, they are also covering all costs to take the compound to clinical proof of concept. MSRD may extend this collaboration beyond proof of concept, but then there is a need to have new negotiations and a new deal. And in the event that MSRD decides not to extend the collaboration, but then they are entitled to a low single-digit royalty on future sales of the product. Next slide, please. This deals brings many positive bits to Irilab. It brings us cash flow eight and a half million US dollars in the near term. As I mentioned, it secures all the funding to take, all financing to take this compound into clinical proof of concept in two different populations. And it of course provides additional external validation of what we're doing and the science that we are driving. And of course, it particularly also points out the potential of 757 in apathy. We have never communicated the total value of this steel, but just to give you as a benchmark, to take a compound into phase one and all the way up to a clinical proof of concept, that is estimated in this industry of circa 25 million US dollars. Next, please. I'll give you a very brief summary of the progresses in the project. For Mestopetam, we are continuing preparation for a phase three start, and we are doing activities that are supporting our business development activities. For PiretMet, as I mentioned, we had the DSMB for the REACT-PD study, giving unanimous support to continue without changes and just complete the study and get the readout. 757, we entered clinical testing and we have started up the collaboration with MSRD Otsuka. And for our preclinical compounds, 942 and 1117. Our preclinical projects, they are continuing according to plan. Niklas will come back and give you more details on the R&D side of what's happening in the projects, but this is the top line summary. Next slide, please. Financial aspects in the quarter. We have now received the upfront payment from MSRD Otsuka, 3 million US dollars. We took a decision to draw 25 million Swedish crowns from the loan facility provided by Fenja Capital in last December. And we have now full financing of the 757 compound Development all the way to and through clinical proof of concept. The financial position that we have today, that is such that we now will be able to drive through next key value driving milestones, and that is the METS Dompetan partnering for phase three, and it is bringing Pyramid Phase 2b, the REACT-PD study, all the way to completion and report top line results. Next slide. As a way of bringing more information of our projects out, we are participating and presenting at investor meetings. We've done so also the second quarter. And here on this slide, you see listed where we participate, presented during the second quarter. So with this, I think it's time now to bring Nicolas to the stage and give you more details about all the progression that we've seen in the pipeline. Please, Nicolas.

Thank you very much, Gunnar. give you a brief update on the status of our programs. And as you all remember, we have built a pipeline over the past few years addressing all the different stages of Parkinson's disease and the unmet needs in the disorder. Next. So with mestopetam, which is our most advanced compound, ready for phase three now, we have a drug which treats dyskinesia, which is a huge issue. And there is very poor treatment options today on the market. This is a drug which also has the potential to treat psychosis, so there is ample opportunity for expansion of the indications going forward. Next, please. Piripimat is a pioneering drug which has the potential to treat falls in Parkinson, which is one of the biggest problems, one of the most costly problems for payers around the world. in terms of the direct cost for the problems and also the cost for the patient that falls. Next, please. 757, addressing apathy. I'll come back to that. Gunnar has talked a little bit about it, but this is the third compound we've now brought into clinical trials. A quite impressive achievement of a small organisation like ours to actually be able to push forward three programmes at the same time. Next. 942, representing an area which is poorly treated in Parkinson's disease, and that is the cognitive aspects of Parkinson's disorder. Next. And then, last but not least, 1117, which has the potential to become a mainstay treatment for Parkinson's, the motor symptoms, basic symptoms. all the way from the first diagnosis of PD through the disorder in full. Very interesting programme as such. Next, please. We'll go to Mr Opetarm and talk about the most recent progress. Next, please. This is a first-in-class compound acting as a D3 receptor antagonist. This is the first D3 receptor antagonist that is actually proven to have efficacy in lids in Parkinson's disease. There's lots of data out there in the literature suggesting the D3 receptor as an important player in the genesis of dyskinesias. Not only in Parkinson's disease, but also in other types of neurological disorders. We have built a patent portfolio, which we are expanding at present. We expect to have patent exclusivity or the potential to have patent exclusivity into the 40s. So that's a very long period, very fresh patents. Mentioning the first in class and mentioning the mechanism here is an important aspect of the program from a commercial perspective. Those responsible for actually paying for treatments across the globe, that's in some societies, it's the governments and in some societies, there are insurance companies paying, but they are extremely focusing on novel mechanisms, novel mechanisms that can treat the disorder in a new way. So therefore, this adds value to the programme. Next, please. The progress during the past three months has been steady, as Gunnar implicated. We are right now in preparation for discussions with European authorities. If you all recall that we had a very successful meeting with the FDA concerning the plans that we have for phase three, full acceptance of our strategy. But here we also want to have some input from European countries and the EMA, of course, at the end of the day, so that we can actually adapt if there are specific aspects that are necessary to do from their perspective. We're also looking at market research activities. I mentioned that briefly before, but we are looking at how to best position mestopetam in today's treatment algorithms. and we have collected information from payers and from paying organisations, experts around the world, helping us to actually shape the final writings of the protocols for the Phase 3 programme. Then we have the possibility to actually start this programme at the end of the year or early 2025. it's not very smart to start a study in Christmas times. But in principle, we could start at the end of the year, or the turn of the year. There has been some external validation of our internal research on the preclinical side. There has come a publication indicating that the efficacy that we have detected in our assays and in our models actually is corroborated by studies done by others. And in addition, the scientists actually discovered that there is a reestablishment of synaptic connections or neuronal connections in the brain after treatment with mestopetone. And this is a kind of an indication that there could be disease modifying properties involved in the treatment effect of mestopetone. This is something we will follow closely over the coming years. Next. Piripimat. Next, please. We have an ongoing randomized study, as you all know, collecting data on falls. Falls is one of the biggest problems, as I said. We have high costs and lots of suffering in the Parkinson's operation due to falling. About half of all patients with PD, the diagnosis falls actually recurrently. So the status of the study is that we're running it across European countries right now. We have communicated that we will complete the recruitment in Q3 this year. which means that after the one month run-in period, where we collect baseline data, and then the three months randomized treatment period, then we have the follow-up meetings, and then we have the database lock. After that, we can report data. We expect to be able to do that within Q1 next year. Next, please. This is also a first-in-class compound, novel mechanism with a novel stem name by WHO. I've said that a number of times, but these are really important pieces in the puzzle of building the commercial value of the compound or the program. Next, please. So, As Gunnar mentioned, we had the final pre-specified meeting, or not we, but the Drug Safety and Monitoring Board, which is a vehicle responsible for monitoring safety and the data integrity in any clinical trial. And in this case, they did their last pre-specified assessment of the study, and they advised us to continue as is. which is very good news for the trial. Next, please. Next. Yeah, sorry, go back one. As I said, we will complete the study in Q3 in terms of randomization, which means that we will be able, possibly able to deliver data in Q1 next year. So, the 757 programme, our third programme entering into clinical trials, addressing apathy. And this is, as Gunnar explained, a programme which is fully financed. We have prominent collaborators on board, both Michael J. Fox Foundation and MSR Diotsuka, supporting the programme fully financially. And apathy represents today a huge unmet medical need in Parkinson's disease, and other neurological disorders. And that's why we are, together with MSR Diuzuka, building a strategy for both Parkinson's and possibly Alzheimer's disease, or actually Alzheimer's disease. Next, please. This drug has the potential, like to be the first drug in a new class to actually treat apathy. We have received regulatory approval during the quarter to start phase one. We have started the phase one study. We had a record-breaking time lag between approval and start, actually. We're proud of that. So we started phase one a couple of weeks after the approval. We have... as mentioned, full funding for the programme. And the joint steering committee that we have set together with MSRD is now operative, and we are working together to build the protocols for the coming studies. So a very successful start of both the study and the collaboration with MSRD. Next, please. The preclinical programmes are running as we have discussed. Next, please, we'll go to 942 first, where we have a huge problem for Parkinson's patients is the cognitive decline that occurs during the course of the disease. And there is a huge population out there with this problem. We estimate that around 5.8 million patients that are addressable. Similarly, for 1117, we have around 5.7 million patients who could benefit from a drug which treats the hallmark symptoms of Parkinson's disease without the complications. Next, please. The cognitive issues are huge in Parkinson's disease. About 25 to 30% actually have severe forms of dementia. But then also another 25 to 30% have what's called MCI, or mild cognitive impairment. And these are difficult to treat today. There is one approved drug to treat these symptoms, but it has also a lot of side effects. So here we have an opportunity actually to provide something that could help these patients much better. Next, please. With the program development during H1Q2, we have developed additional data or generated additional data on the cognitive aspects of the drug improvements. We have started the complex CMC work that is needed, and that is the GMP manufacturing of the drug. And we have also initiated the production of drug product for phase one studies. So next step will be the TOC studies when we have the API for those. And the start of those studies is of course dependent on availability at CROs. Next, please. For 11.17, which is a novel strategy to provide a once daily treatment for Parkinson's disease without the complications that are well known for levodopa. And here we have just a graph showing the 24 hour, actually this is 10 hours, but the sustained efficacy over 24 hours after one dose of the drug. It hasn't been seen before with any other type of Parkinson's treatment, this longevity of efficacy. Next, please. So here we have run through 1117 through a number of very important and predictive models of Parkinson's symptoms. We know that we can treat over a long time period. We know that we can switch from levodopa to 1117 without complications. We know that 1117 in chronic treatment does not generate the complications with fluctuations, as you see with levodopa. We have full accountability for the DMPK, the drug distribution in the broad body and in the brain. and we know which doses we would go for in tox studies and also in clinical trials. So right now we are in the process of developing the synthesis of the drug product. And this is a highly potent compound, so we won't need very much drug over the years. We have calculated that for a lifetime treatment with this drug, this potential drug, around four grams would be enough, a fun fact. And also we have recently filed patents around this, both active patents covering the invention, but then also patents defending the core scope of the invention. Next, please. I will turn over to Victor and let him go through the financial aspects of the recent period.