IRLAB Therapeutics AB

STO:IRLAB A

Earnings Call Transcript 2024-Q3

[Operator]

Welcome to yet an inspiring quarterly presentation by research company, IRLAB. Today, presenting today will be newly appointed CEO, Kristina Torfgard; Executive Vice President, R&D, Nicholas Waters; and CFO, Viktor Siewertz. After the presentation, there will be a Q&A with participating equity analysts. Hello, and welcome, Kristina.

[Kristina Torfgard, executive]

Hello. Good morning. Thank you.

[Operator]

Good morning. You came on board IRLAB 1st of August. Could you please tell us a bit how this first few months have been with the company?

[Kristina Torfgard, executive]

Yes. So this is the first quarter for me as a CEO of IRLAB, and it has been eventful, and I have got quite a lot of very good insight in the company. And it's a great company. And I would say that everything goes back to really the organization. It's a very experienced and dedicated team behind the company. And I'm very, very honored and it's great to take the lead, and leading the company now when we have such a very important mission to develop new innovative treatments for people suffering from Parkinson's.



And I'm very, very happy to be part of this team also and to be part of this journey that we are doing because what we are really aiming to is to have -- make sure that people with Parkinson's can get a much better life in the future.

[Operator]

Yes. Thank you, Kristina. We are all very thankful for what you are doing. So please go ahead with your Q3 presentation, and I will be back for the Q&A.

[Kristina Torfgard, executive]

Thank you. So first slide. Next slide. This is our disclaimer. So today's agenda, I will introduce with giving you an update on the news for the Q3 period. I will then hand over to Nicholas Waters, Executive Vice President, Head of R&D. He will talk about the R&D update during the quarter and then to hand over further to Viktor Siewertz, CFO of the company, and he will talk about the financials. And at the end, I will have some concluding words. And after that, we are opening up for the Q&A session.



Next slide. So I wanted to share this slide as a start for the Q3 presentation here. For me, it's very, very impressive that IRLAB has such a fantastic work with developing drugs, drug candidates that can actually treat all the different symptoms and complications during the Parkinson's disease.



Next slide. Yes, next. Yes. So as you can see, we have 5 candidates. They are all first-in-class. And you can see on the right side there that we have Mesdopetam, Pirepemat, IRL757, IRL942 and IRL1117. And altogether, you can see that we are going or we are aiming to treat all the different symptoms appearing during the journey for people suffering from Parkinson's disease.



So next slide. We have had a very good third quarter. I have summarized this per the candidates. So if we start off with Mesdopetam, we had a very successful period when we got the new patent approved and granted for Mesdopetam, and this allows us to have an extended patent situation, which will take us into 2040.



We have also got and presented a meta-analysis at a very, I would say, important international meeting that was held in the U.S. earlier this fall. And there, we presented data from a meta-analysis showing that it's a very good effect from 2 studies that we have performed. So this strengthens us moving forward.



For Pirepemat, we had the DSMB that they told us that we can go ahead with the ongoing Phase IIB study, REACT, without any changes, which was very good. And later on, in last of September, we also closed the recruitment for the study, and we had the last patient included and randomized in the trial. Also for Pirepemat, we had during this period, a new patent granted, which also will extend this patent and IP situation to our favor.



Next slide. So for IRL757, we started the SAD study and the first healthy volunteers have been treated. That's a single ascending dose study, and we continue now with a multiple ascending dose. We also received USD 2.5 million in connection with that, we started also a second Phase I study on IRL757 in healthy older adults.



Next slide. So I have also had the opportunity to have a number of interviews as well as investor presentation during this period, both for BioStock, Pareto Securities Health Conference, and Redeye Neurology Day recently. Together with that and also the interviews that I performed; you can find if you would like to watch that on our website.



Next one. So if I would summarize the progress for the different candidate drugs that we have for Q3, we start off with Mesdopetam, where we are preparing for starting Phase III. We have performed regulatory interactions and have had very good, I would say, alignment there for the different regulatory regions. We have also done a market research work where we have learned a lot from health providers, which will strengthen our case for mesdopetam. You will hear more about that. For pirepemat, we have, as I said, we have -- we continued and completed according to the study, Phase IIB study, REACT, and we have also completed the enrollment for the study.



IRL757, we have the single-dose ascending dose study and MAD ongoing together with food interaction that we do in the same study, which is very good already to get that information there. In addition, we have also now ongoing study in healthy elderly in order to understand more about how it performed, the drug performed in elderly patients as many of the Parkinson's patients are older.



And this is a collaboration with Michael J. Fox Foundation as well as the MSRD/Otsuka. For IRL942, we are at the preclinical stage, and we continue with the preclinical studies there as well as the chemical work we are doing for the drug product and drug substance needed in order to start for the Phase I program. And the same for IRL1117. Preclinical studies are ongoing. We are documenting the drug substance and drug product for starting the Phase I program.



So next slide. So by that, I would like to hand over to Nicholas to take us through the R&D update.

[Nicholas Waters, executive]

Thank you, Kristina, and hello, everyone, listening today. I have the pleasure to actually present some of the updates in the R&D arena at IRLAB. So first, a few words around mesdopetam. Can I get the next slide, please?



As you all know, this is our effort to actually improve lives for patients with suffering from levodopa-induced dyskinesias. Next slide. This is a first-in-class compound with a novel mechanism. And the novelty around the mechanism, the inhibition of the, or the dopamine D3 receptor antagonist blocking D3 receptors, which are erroneously appearing in certain brain areas during the LIDs periods. The importance of the novel mechanism has been clarified to us during our discussions with health providers during the year.



This is a very valuable aspect of the program. We carry patents, which, for this asset, which has also been expanded, as Kristina alluded to, during the period. We have new patents in Europe. We are working to get new patents also in the U.S., additional patents, which will bring exclusivity into the early 40s for this product.

Next, please. So we've had a number of additional regulatory interactions during the period. If you remember, going back to February, we had a very successful discussion with the FDA, where we agreed on the basic outline of the Phase III program, specific aspects of the design of the studies that we want to conduct. So we had a very nice alignment with the FDA. We brought that back to Europe, and we've talked to and seek scientific advice from both the German and the Portuguese regulatory authorities.



These are experienced in Parkinson's disease, and that's why we went to those first. And it's clear to us that we have a very nice alignment between the FDA and European agencies in terms of how study should be conducted, especially when it comes to the primary endpoint, the inclusion/exclusion criteria and also the safety update or safety study that is necessary to run in parallel with the efficacy studies.



In addition to that, we have also spent time interviewing health providers, both in the U.S. and in Europe. We do this because their input is really, really important to finally design the program in the best possible way so that we can position mesdopetam the way they see mesdopetam. And we learned a couple of interesting things during that exercise. First of all, both in the U.S. and EU, the health providers view a novel treatment for dyskinesia, very important. And especially when it carries, it comes with a new mechanism of action.



Drugs that are used today or treatments that are used today, they also come with a lot of side effects and problems for the patients. And here, they see an opportunity for a drug which does not carry those complications, but with a good anti-dyskinetic effect, clinically meaningful. The other thing is that a new mechanism also opens up possibilities for a broader use in more patients today.



The third thing we learned, which was really, really important and that is more related to Europe, and that is that the European health providers, they see mesdopetam as a drug which could treat disabling dyskinesia, and disabling dyskinesia in Parkinson's patients has no treatment. And this opens up possibilities for interesting discussions concerning pricing and positioning of the product in Europe. So we see a huge opportunity for mesdopetam, both in the U.S. and Europe based on the data we have collected during the past period.



In addition to this, we, mesdopetam has been evaluated now by external groups, groups which we have no contact with. So these are independent, truly independent studies. And there is a number of such studies ongoing as far as we know, but there was one published recently during the spring this year, confirming the anti-dyskinetic efficacy of mesdopetam in preclinical models, similar to what we've seen in our studies.



But in addition, they also see that mesdopetam has the peculiar property to actually restore or reestablish synaptic connectivity in the brain of rodents, which have dyskinesia. So this is a new aspect of the program, which we are not surprised about, but it's very interesting to see that others see this possibility as well, which increases the potential for a really beneficial effect with long-term treatment with mesdopetam. Next slide, please.



Pirepemat, our ongoing Phase II program. Next, please. This is a drug which we have designed to treat falls to reduce the risk of falling. Falling is the biggest problem for people living with Parkinson's disease. About half of all patients are fallers. And in that, there is a fraction of so-called recurrent fallers, which falls several times a month. And that is the population we are looking at in our study.



The study we are conducting right now has been conducted in France, Poland, Spain, Sweden, Germany and the Netherlands. We have completed the recruitment. We did that in the end of September. So we are now looking at a 1-month baseline period for the final patients, 3 months on treatment, placebo or active drug. And then we have the regular workup of the data. So we can foresee that we'll have top line data at the end of Q1 next year. Next, please.



This is also a first-in-class compound with a novel mechanism of action. Also in this program, we have expanded the patent exclusivity, both in Europe and U.S. So it stretches now into the 40s, which is, of course, important when we talk about the value of the program. Next, please.



So in the study, as Kristina mentioned, we have had a number of DSMB independent Safety Monitoring Board meetings during the course of the trial, which is necessary for any trial. And they have encouraged us to continue the study without any changes during the course of the trial. What we have learned from the study, we've discussed that a little bit before. But what we've learned during the course of the trial is that the patients that we have included in the study, they fall much more than we thought from the beginning of the trial. And that means that we will have a very good signal-to-noise ratio in this study. This has also helped us to actually reduce the number of patients necessary to include in this Phase IIB study, which means that we can now conclude the study this year, early next year. Next, please.



We, as I said, we anticipate now to have top line data at the end of Q1. Next, please. The apathy program that we are running together with Michel J Fox Foundation and MSRD, which is a company in the Otsuka family. This also represents a first-in-class treatment for apathy, which today has no treatment in neurological disorders. There is no treatment for apathy at all, actually.



Next, please. This is a big problem. About between 20% and 90% of all patients with neurological disorders actually experience apathy on a daily basis. So it's a huge complication, huge problem. And we are trying to address that with IRL757. We are addressing the, one of the hypothesis around the physiological changes in the brain so that we can restore function in certain circuitries in the brain between the cortex and basal ganglia.



Next, please. This is a drug which has potential for symptomatic relief, but also for disease-modifying properties. As I said, we are working together with Michael J. Fox through financing of the SAD and MAD part of this Phase I program that we're running right now. And we have also entered into a collaboration—we did that late last spring—with MSRD Otsuka to actually bring this molecule all the way through proof of concept in patient populations. We have already successfully completed the single ascending dose part of the study that is rising doses. We've looked at 4 different dose levels, increasing doses in healthy younger volunteers. That went very well. We have seen a very nice PK and NPK profile of the compound. We get the exposures we want to be able to go into efficacy studies later on.



So, now we've also started the multiple ascending dose part of the Phase I program, and that is giving doses every day during 10 days in the MAD section of the study. We expect to finalize the SAD and MAD before Christmas. And we have also initiated a Phase I study, single ascending dose study, in elderly, healthy volunteers, that is people above 65 years of age. And that is because when we move into patient populations, they will be around 60, 65 years old in average. So, we want to know the safety, tolerability, and the pharmacokinetic properties of the drug also in that elderly population. And this final study was a study that we are doing now together with MSRD Otsuka. It's the first clinical study we're doing in the collaboration together with them.



Next, please. Looking at the preclinical programs, we have steadily moved those ahead. Can you give me the next slide? We start with IRL942, we're looking at a drug which could treat cognitive dysfunctions in neurological disorders. There's a huge need for better, more efficacious treatments with less side effects for this population. And there's a huge population that are eagerly awaiting a new treatment for their cognitive impairments.



And then with IRL1117, we have, what we think, could be the next generation of basic treatment of Parkinson's disease. And we are targeting here a once-daily treatment for the classical Parkinson's symptoms, tremor, rigidity, and bradykinesia. And that is without inducing any of the complications that are so well known for levodopa.



Next, please. Talking about the cognitive impairments. We know that about 10% to 15% of all adults above 65 have cognitive decline that goes across all individuals. But the risk for cognitive decline is much, much higher in people living with neurological disorders, point prevalence, 25% to 30% in Alzheimer's for that matter, and PD, as well.



So, this drug – next, please – has the potential to be a better treatment. The current status of the program is that we are now working ourselves through the important preclinical studies. We have initiated GMP manufacturing, development and manufacturing of drug substance that is necessary for the coming studies, but also drug product for clinical trials. And drug product means a capsule or a pill, where the drug substance is, of course, included. We expect to be Phase I ready during '25 with this program.



Next, please. Going back to IRL1117, which is a really interesting opportunity. We've discovered it here in our laboratories. It's a representative of new class of anti-Parkinsonian treatments. And it thus has the potential to be the first one in the new drug class. And main points with this program is that the problems with levodopa is the recurrent dosing. Patients take levodopa up to 5-8 times a day, and that comes with a lot of complications. And we think that if we can develop a drug which acts similar to levodopa, but can be given once daily, we will avoid a lot of those complications, but still have a very sustained anti-Parkinsonian effect. We are currently developing the large-scale synthesis for this molecule. This is a very potent molecule, which means that we need to do in very specific facilities.



Next, please. So, we've taken IRL1117 through a number of preclinical models, demonstrating that we have a single-dose efficacy over 24 hours in animals, which are parkinsonian. We have improvement of motor function in repeat dose studies over a month, once daily dosing. And we do see that we have a functional motor response. We see the effects we want to see, but without developing the complications that levodopa develops during the same time period.



We can also see that if we start treating animals with levodopa and they get the complications, fluctuations in motor function. When we then switch them to IRL1117, we see that those fluctuations go away, but with sustained anti-parkinsonian effect. So we have created a package that is really compelling in terms of proving our points with this product.



As I said, this is a very high potency compound, and we have shown that we have relevant exposures in a number of species. And we are currently developing the industrial synthesis of the API or the drug substance.



We filed a number of patents around this invention, both active patents and protective patents, defensive patents. And those were filed a couple of years back. So we have patent protection all the way into the 40s with this program. Next, please.



So I will leave over the word to Viktor after this. Viktor, financing.

[Viktor Siewertz, executive]

Thank you, Nicholas. We can go directly to the next slide, please. The financial highlights of Q3. We had about SEK 90 million in cash. However, this quarter, it becomes a little bit tricky because we have got quite a lot of money paid out from MSRD to cover the cost for IRL757. So out of the money, there are still SEK 34 million that we haven't used for the IRL757 activities. So those are sort of earmarked to the coming activities in IRL757. So that is SEK 34 million out of the SEK 90 million that we have in cash at the moment.



If we look at the middle bar graph in the slide, we can see that our own cost is about SEK 30 million. And then there's the light gray bar at the top, and that is the cost for IRL757, which is covered by the grants from MJFF or Michael J. Fox and the payments from MSRD. So those doesn't really affect us because they are cost in the company, but they are also matched by the same amount of income.



So our own cost is about SEK 30 million. Of this SEK 30 million, there is about SEK 10 million, the dark gray part of the bar that is external clinical cost, which is cost for studies done by CROs that we have hired to do things. And mostly, of course, that is relating to the Phase IIB study with pirepemat, which will end in -- as Nicholas said, we are anticipating top line results in the end of Q1 next year. And I guess the cost will carry on for maybe another quarter, but then those costs will -- there will be no more cost for that study.



Headcount, still around 30 people. We're keeping it stable around there, an effective amount of people working in the labs. And after the quarter ended, we reported that we will get about, or not about, we will get exactly $2.5 million in a milestone payment relating to the IRL757 development. So we will report an income of SEK 26 million in Q4. Next slide, please.



This is just a summary, saying basically the same things that I've just alluded to. We have net sales compared to last year. We have worked with that. So now we have quite substantial net sales for a company like ours. We can see that our cash flow has decreased, which is good because it's negative. So now we had SEK 43 million in negative cash flow instead of SEK 131 million last year. So that is good. And maybe that is reflected in the higher share price that we have now compared to last year as well.



So having said that, Kristina, please, some concluding remarks.

[Kristina Torfgard, executive]

Yes. Thank you very much, Viktor. And so concluding words. Yes. Next slide, please.



So summarizing the key highlights for the third quarter. And after, first of all, we had -- we were able to complete the REACT study as planned with a good feedback from the Data Safety Monitoring Board, DSMB. We also finished the recruitment in the REACT study as planned.



So we have a sufficient number to finalize this study now early next year. And all this is a progress towards the finalization and readout as planned for pirepemat. We had 2 patents granted during this period, one for mesdopetam and one for pirepemat in Europe and U.S., respectively. This is really great because that strengthened our commercial value, both for the candidates, but also for the company.



And then finally, we had also the outcome of the $2.5 million financing that we got in conjunction with that we started to dose the first Phase I study in collaboration with MSR Otsuka. And to point out that IRL757 is fully funded throughout the proof of clinical phase. So next slide, please. So this pipeline, I think, coming from outside, looking at this pipeline, it's impressive. It is a small company, I would say. Sorry. So this is a really fantastic pipeline is what I'm saying for such a small company, but it's the people behind that makes this moving on.



So first of all, mesdopetam, we are Phase III ready there, and we need to finance the Phase III program and commercialization. So that's ongoing. We also have the opportunity here and go into another indication, Psychosis, which, of course, will increase the value of the candidate mesdopetam.



We also have pirepemat, where we have the ongoing Phase IIB study. where we are looking forward to the top-line results end of first quarter 2025. And there, we also have the opportunity to increase to another indication, dementia, which is also a huge unmet medical need. For IRL757 apathy in neurology, where we are going to evaluate Parkinson's disease and Alzheimer's disease, we look forward now to the top-line results on the Phase I studies first quarter 2025. For the preclinical assets, IRL942 with a cognitive impairment in neurology, we are preparing to enter Phase I next year. And for the last one, IRL1117, which really can bring a revolution in the Parkinson's disease with this treatment, we are really looking forward to take that into clinic next year.



So next slide, please. So we see multiple possibilities now to increase the value for the company during the coming 12 and 18 months. So for mesdopetam, we have the ongoing BD activities that are key and also initiation on the Phase III program for pirepemat, we have the top-line results we are looking very much forward to next year and starting up with the BD activities also for this candidate. For IRL757, we are completing the Phase I studies, which is the single ascending dose, multiple ascending dose as well as the study in older patients. And we are very much looking forward also to kick off the Phase II study, proof-of-concept study, which is called efficacy and safety signaling finding study.



And the 2 preclinical assets, we are really looking forward to get them ready to enter Phase I for both of them. So with that, I move on to the next slide, please. And I think I'll stop there, and it's time to open up then for the Q&A session. So I hand over to the... You.

[Operator]

Thank you so much, Kristina, Viktor, and Nicholas for your presentation of your results and your fantastic, very impressive portfolio, of course. We will soon start off with Fredrik Thor. But first off, I would like to address the viewers and say that you are all welcome to ask your questions in the live chat, and I will try and raise as many of them as I can. So please, Fredrik Thor of Redeye, welcome to ask your questions.

[Fredrik Thor, analyst]

Yes. My first question is about the cash runway. Can you say anything about that? And I guess, what we can expect for the business development activities, hopefully, before the cash runs out? And also a second question about that regarding the earmarked SEK 34 million, how they will be spread out during '25 in terms of costs?

[Kristina Torfgard, executive]

So I think it's a question for you, Viktor?

[Viktor Siewertz, executive]

Yes. Maybe there was quite a few questions. So remind me if I missed to answer any one of them. First, the SEK 34 million that is earmarked for IRL757 development. It depends a little bit about how long the studies will take, of course. But I assume that we will spend them during the first and second quarter next year.



Then the cash runway, we had SEK 90 million and SEK 34 million was earmarked and then we will get a refill with SEK 25 million or SEK 26 million in Q4. And we have, as we said, about SEK 30 million per quarter that we need to cover in our own costs, so to speak. So with some easy calculation, that means that we have roughly 3 quarters covered.

[Fredrik Thor, analyst]

No, I think you answered it. And the second question was about the blinded pirepemat data that you presented. If you maybe can remind us a bit about the placebo response from the previous trial and maybe your expectations from this trial?.

[Nicholas Waters, executive]

Yes. We published a press release communication earlier during the quarter relating to pirepemat and the ongoing study. We have previously talked about the baseline. Baseline is higher. We have a better signal-to-noise ratio. We have also observed during the course of the trial that the patients that are included in the study, they fall less, about a 30% reduction in fall rate aggregated over all patients. So of course, we don't know if it's placebo or if it's treatment that patients have, of course. However, there's little data published on fall rates in studies, not so very common this type of studies. But those that have published data, they indicate that there is a very little effect on fall rates by placebo. That's what we know. And there isn't very much more to say.



In our Phase IIA study, for instance, we had no change in the scales that we use to address falls in that study, while we had a significant movement in the scale for the treatment arm in the Phase IIA study. If that is produced, we don't know.

[Fredrik Thor, analyst]

The final question was about, you mentioned also Nicholas, the disabling dyskinesia as a potential in Europe. Maybe can you expand on that patient population and the need and so on?

[Nicholas Waters, executive]

The patient population with disabling dyskinesia is roughly half of all patients who have dyskinesia. So it represents roughly 15% of all patients diagnosed with Parkinson's. And there is no treatment for them in Europe. In Europe, there is off-label use of another treatment for dyskinesia per se, but it's used at low doses, not very effective. But we are targeting a larger population with mesdopetam in Europe as we are in the U.S.



And this is a really important, little word means a lot when it comes to discussions with health providers in terms of pricing and the positioning of the treatment, somewhere between the regular adjustments of levodopa, which is usually done to reduce dyskinesia, that is the patients are treated with lower and lower doses with levodopa to avoid dyskinesia. That's the first step. And then you add on different types of treatments. And today, the next step would be the surgical treatments, such as Duodopa or even deep brain stimulation electrical devices in the brain. And here, we can actually squeeze in mesdopetam in between those strategies, which is a really important positioning of the product.

[Operator]

Thank you so much Fredrik Thor of Redeye, and we are ready to move on to Alexander Krämer of ABG Sundal Collier.

[Alexander Krämer, analyst]

Good morning, and thank you for taking my questions. I have two actually, probably for Nicolas, one on IRL757 and one on Pirepemat, maybe to start with the IRL757 question. I mean now you're running two IRL757 Phase I studies, and my question here is, why was it decided to run another Phase I in elderly patients instead of kind of combining it with the Phase I study that you have already started previously. Was it sort of a request from MSRD or was it more of the decision to divide the costs between the Michael J. Fox Foundation and MSRD to that study?

[Nicholas Waters, executive]

Well, that's an easy one. The population is different. These are elderly or older healthy volunteers. So therefore, you have to do a new ethics application, which means this has to be a new study. So there is nothing relating to cost or budgets or anything like that. It's just a classical strategy you do healthy younger volunteers and then you do healthy elderly in separate studies, that has to do with the regulatory pathways for those two populations.

[Alexander Krämer, analyst]

Okay. I see. Is there any other differences between these 2 Phase I studies?

[Nicholas Waters, executive]

Not really. The Single Ascending Doses, both in the healthy younger and healthy elderly. We are not conducting a MAD study in the elderly.

[Alexander Krämer, analyst]

Okay. Good. Then my second question is on Pirepemat . I mean, so recently, I mean, you released that you have more than 100 patients in that study now. which is a bit vague. I mean, in previous quarterly calls, you mentioned that you're expecting around a patient size of around 120 patients, which means a 25% reduction. Could you be a little bit more precise on how many patients you have in the study? And if this is like we have an additional reduction?

[Nicholas Waters, executive]

No, it's not an additional reduction. We have not talked about the exact number of patients, and that remains an open question. It depends on what the dropout rate will be, but we are clearly above 100 patients in the study. When we go back to our power calculations, there is basically no difference between 90, 100, 110 or 120 patients in terms of the power of the study based on the higher baseline and the change that we see in the blinded data. So it's yes, we still believe we have the same likelihood of detecting, if there is an effect, we still believe we have the same ability to detect that with this population as with any larger population.

[Operator]

All right. Was that all from you, Alexander?

[Alexander Krämer, analyst]

Yes, that's all from my side.

[Operator]

Okay. And after that, we will move on to Arron Aatkar of Edison Group.

[Arron Aatkar, analyst]

Looking at the new market research for Mesdopetam, you stated that the planned Phase III design aligns with the desires of health care funders. I was just wondering if you could expand on that a little bit. Is this in terms of the choice of endpoints or other factors?

[Kristina Torfgard, executive]

Do you want to take that, Nicholas? I think you have for that.

[Nicholas Waters, executive]

Can you repeat the specific question once again?

[Arron Aatkar, analyst]

Sure. So in the market research for Mesdopetam, it was stated that the planned Phase III design aligns with the desires of health care funders. I was just looking for a little bit more color on that.

[Nicholas Waters, executive]

Yes. It has to do with the length of the study, 3-month studies is, of course, what they also want to see. Then the open-label extension safety portion of it is what they want to see. As I alluded to during my presentation, they've also given us feedback on the population that they are most interested in, and that is the disabling dyskinesia population. A deeper dive into that actually is because that when they see the protocols, for our trials, they acknowledge that we are looking at disabling dyskinesia in our trials. That is what makes them excited. This differentiates our study from our program from other programs, I assume that they have seen. That's my assumption. I don't know that, but that's my assumption.

[Arron Aatkar, analyst]

That's helpful. Another quick question on Mesdopetam. Kristina touched on it, looking at the expansion to Psychosis. Just curious to know if this would be a label expansion? Or do you believe that, that would require further clinical studies?

[Nicholas Waters, executive]

Of course, you would need further clinical studies. This is something we've had in our pipeline since we started the program basically. The drug behaves as an anti-dyskinetic and an antipsychotic in models of Parkinson's disease. We published a preclinical paper recently on that issue together with external collaborators.



The drug is as such, we've actually had discussions with regulatory bodies going back a couple of years, how to design a PDP study that is Parkinson's Disease Psychosis. We have a protocol for it. This would become a label extension or expansion, of course, for the product, but it actually broadens the scope and the value of the product quite significantly. with that addition. So we haven't initiated any studies or anything like that, but this is a clear opportunity to expand the use of Mesdopetam in the Parkinson's population.

[Arron Aatkar, analyst]

Excellent. One more question, if I may, on IRL757. It's great to see the wider opportunity with Parkinson's disease, but also with Alzheimer's disease. Just curious to know how that might look in terms of later-stage trials. So will this target these populations separately? Or will this look at apathy as a whole?

[Kristina Torfgard, executive]

So currently, what we are going to do is we are running 2 separate studies then in the different 2 indications. As those patient population are quite distinct, different, I would say that there is a requirement to have 2 different types of studies for the future program, both Phase II and Phase III.

[Operator]

All right. Thank you so much, Arron Aatkar of Edison Group. I will raise one question from our viewers. Mattias Olsson asks, earlier, you expected a Phase III start for Mesdopetam in Q4 '24 or Q1 2025. And now it's just 2025. Could you please elaborate a bit on this change?

[Kristina Torfgard, executive]

Sure. Yes, yes. So when we had that earlier on the slide and expecting to have end of this year or early next year, we had assumed that the BD discussions would have been progressing a little bit faster than they had. So that's why we have corrected this. We do have very good discussions. What we have seen also is that the data and the information we have generated through the regulatory interactions and through the patent extension as well as the health care providers is very important, and that is really attracting potential partners. But I think we are moving forward, and we are in a good place.

[Operator]

Okay. Thank you, Kristina. And that will conclude this broadcast. So first of all, thank you so much to the executive team of IRLAB. Thank you.

[Kristina Torfgard, executive]

Thank you so much for listening.

[Operator]

I can add that we are already looking forward to the full year -- the year-end report within 3 months. And I also want to say thank you for the viewers who have been joining us. Thank you.