Welcome to yet an inspiring quarterly presentation by research company, IRlab. Presenting today will be newly appointed CEO, Kristina Torfgaard Executive Vice President, R and D, Nikolas Waters and CFO, Victor Siewert. After the presentation, there will be a Q and A with participating equity analysts. Hello and welcome, Kristina.
Hello. Good morning. Thank you.
Good morning. You came on board IR Lab 1st August. Could you please tell us a bit how these first few months have been with the company?
Yes. So this is the Q1 for me as the CEO of Eisleb, and it has been eventful. I have got quite a lot of very good insight in the company. It's a great company, I would say that everything goes back to really the organization. It's a very experienced and dedicated team behind the company.
I'm very honored, and it's great to take the lead and leading the Company now where we have such a very important mission to develop new innovative treatments for people suffering from Parkinson's. 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.
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 and A.
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 Niklas Water, Executive Vice President, Head of R and D. He will talk about the R and D update during the quarter, and then to hand over further to Victor Siewerts, CFO of the company, and he will talk about the financials. At the end, I will have some concluding words. After that, we are opening up for the Q and A session. Next slide.
I wanted to share this slide as a start for the Q3 presentation here. For me, it's very, very impressive that IO Lab 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 1st in class. You can see on the right side there that we have mestopetone, peripemat, 757, 942, and 1117. 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 Q3. I have summarized this per the candidates. So if we start off with Mesto Pelchan, we had a very successful period when we got the new patent approved and granted for Mesto Petan. This allows us to have an extended patent situation, which will take us into 2,040. We have also got and presented a meta analysis at the very, I would say, important international meeting that was held in
the
US earlier this fall. There we presented data from a meta analysis showing that it's a very good effect from 2 studies that we have performed. This strengthened us moving forward. For peripamat, we had the DSMB that they told us that we could go ahead with the ongoing Phase 2b study, REACT, without any changes, which was very good. 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 Piripemat, we had during this period a new patent granted, which also will extend this patent and IP situation to our favor. Next slide. For 757, we started the SAD study, and the first healthy volunteers have been treated, that's a single ascending dose study, while we continue now with a multiple ascending dose. We also received $2,500,000 in connection with that. We started also a second phase 1 study on 757 in healthier older adults.
Next slide. I've 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 Red Dinerology Day recently. Together with that and also the interviews I performed, you can find if you would like to watch that on our website. Next one. If I would summarize the progress for the different candidate drugs that we have for Q3, we start off with mestopetrol, where we are preparing for starting phase 3.
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 Miss Doppertown. You will hear more about that. For PeripMet, we have, as I said, we continued and completed according to the study Phase 2b study, REACT, and we have also completed the enrollment for the study. 757, 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 patients are older. This is a collaboration with Michael J. Fox Foundation, as well as the MSRD Otsuka. For 9 foot 2, 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 project and drug substance needed in order to start for the phase 1 program. The same for 11/17 preclinical studies are ongoing.
We are documenting the drug substance and drug product for starting the phase 1 program. Next slide. So by that, I would like to hand over to Nikolas to take us through the R and D update.
Thank you, Cristina. And hello, everyone, listening today. I have the pleasure to actually present some of the updates in the R and D arena at the OEI lab. So first a few words around Maastau Petal. 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 the 1st 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 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 3 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 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 a 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 Maastepot Dam the way they see Maastepot Dam. 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 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 antidyskinetic 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 mesto bedarm 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 Mestarbutam both in the U. S. And Europe based on the data we have collected during the past period.
In addition to this, Mestopperdam 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 antidyskinetic efficacy of mastopetam in preclinical models, similar to what we have seen in our studies. But in addition, they also see that Maestro Pote has the peculiar property to actually restore or re establish synaptic connectivity in the brain of rodents which have dyskinesia. So this is a new aspect of the programme, 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 mestopeton.
Next slide, please. Piripemat, our ongoing Phase 2 programme. 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, patients with pre proliferative Parkinson disease.
About half of all patients are fallers. And, in that there's 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 work up 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 1st 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 programme. Next, please.
So in the study, as Cristina 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 this 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 2b study, which means that we can now conclude the study this year, early next year.
Next, please. As I said, we anticipate now to have top line data at the end of Q1. Next, please. The apathy programme that we're running together with Michael J. Fox Foundation and MSRD, which is a company in the Otsuka family.
This also represents a 1st 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% 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 757. We are addressing one of the hypotheses around the physiological changes in the brain so that we can restore function in certain circuits 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 1 program that we're running right now. And we've also entered into collaboration with that late last spring, MSR Diotsuka, 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 D and PK 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 1 program and that is giving doses every day during 10 days in the MAD section of the study. We expect to finalise the SAD and MAD before Christmas and we have also initiated a Phase 1 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 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 MSR de Yotsuka. 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? Start with 942. 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. Then with 11/17, we have what we think could be the next generation of basic treatment of Parkinson disease. And we are targeting here once daily treatment for the classical Parkinson's symptoms, tremble, radiculopathy 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 vagina 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 for that matter and PD, sorry. So this drug, next please, has the potential to be better treatment. The current status of the programme 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 1 ready during 2025 with this program. Next, please. Going back to 11.17, which is a really interesting opportunity, we've discovered it here in our laboratories.
It's 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 the 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 it in very specific facilities. Next, please. So, we've taken 11/17 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 11/17, we see that those fluctuations go away, but with sustained anti Parkinsonian effect. So we've 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 the 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 forties with this programme. Next, please.
So I will leave over the word to Victor after this. Victor, financing.
Thank you, Niklas. We can go directly to the next slide, please. The financial highlights of Q3, we had about SEK 90,000,000 in cash. However, this quarter, it becomes a little bit tricky because we've got quite a lot of money paid out from MSRD to cover the cost for 757. So out of this money, there are still SEK 34,000,000 that we haven't used for the 757 activities.
So those are sort of earmarked to the coming activities in 757. So that is SEK 34,000,000 out of the SEK 90,000,000 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 $30,000,000 and then there's a light gray bar at the top and that is the cost for 757, 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 30,000,000 Of these SEK 30,000,000, there is about SEK 10,000,000 the dark grey part of the bar that is external clinical cost, which is cost for studies done by zeroes that we have hired to do things. And mostly, of course, that is relating to the Phase 2b study with biretmot, which will end in as Niklas 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 costs 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 2 or not about, we will get exactly $2,500,000 in a milestone payment relating to the 757 development. So we will report an income of SEK 26,000,000 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've 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 43,000,000 in negative cash flow instead of SEK 131,000,000 last year. And 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.
Yes. Thank you very much, Victor. So concluding words. Yes. Next slide, please.
So summarizing the key highlights for the Q3 and after, first of all, we were able to complete the REACT study as planned with a good feedback from the Monitoring Board, DSMB. We also finished the recruitment in the REACT study as planned. So we have sufficient number to finalize this study now early next year. All this is a progress towards the finalization of readout as planned for Peripemat. We had 2 patents granted during this period, 1 for mestopetan and 1 for peripemat in Europe and US respectively.
This is really great because that strengthened our commercial value, both for the candidates, but also for the company. Then finally, we had also the outcome of the 2,500,000 financing that we got in conjunction with that we started to do the first phase 1 study in collaboration with MSR D. Otsuka. To point out that 757 is fully funded throughout the proof of clinical phase. 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, you know, it's the people behind that makes this moving on.
So first of all, Mestopecan, we are phase 3 ready there, and we need to finance the phase 3 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, mestopetan. We also have peripamat, where we have the ongoing Phase 2b study, where we're looking forward to the top results, top line results end of Q1 2025. There will also have the opportunity to increase to another indication, dementia, which is also a huge unmet medical need. For 757 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 1 studies Q1 2025.
For the preclinical assets, 942, with a cognitive impairment in neurology, we are preparing to enter phase 1 next year. For the last one, 11/17, which really can revolution in the Parkinson disease with this treatment, we are really looking forward to take that into clinic next year. Next slide, please. We see multiple possibilities now to increase the value for the company during the coming 12 18 months. For Mestopetan, we have the ongoing BD activities that are key, and also initiation on the phase 3 program for peripimat.
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 757, we are completing the phase 1 studies, which is the single ascending dose, multiple ascending dose, as well as the study in older patients. We are very much looking forward also to kick off the phase 2 study, proof of concept study, which is called efficacy and safety signaling finding study. The 2 preclinical assets, we are really looking forward to get them ready to enter Phase 1 for both of them. 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 and A session. So I hand over to you. Yes.
Thank you so much, Cristina, Victor and Nicolas, for your presentation of your results and your fantastic, very impressive portfolio, of course. We will soon start off with Frederic Thore, 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 Thore of Redeye, welcome to ask your questions.
Yes. And hello. Yes, my first question was 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 second question about that regarding the earmarked €44,000,000 how they will be spread out during 20 25 in terms of costs?
So I think it's a question for you. Victor?
Yes. Maybe there was quite a few questions. So remind me if I missed to answer any one of them. First, the SEK 34,000,000 that is earmarked for 757 development. It depends a little bit of about how long the studies will take, of course.
But I assume that we will spend them during the 1st or and second quarter next year. Then the cash runway, we had SEK 90,000,000 and SEK 34,000,000 was earmarked and then we will get a refill with SEK 25,000,000 or SEK 26,000,000 in Q4. And we have, as we said, about SEK 30,000,000 per quarter that we need to cover in our own costs, so to speak. So with some ease calculation, that means that we have 3 quarters roughly 3 quarters covered. Yes, so something else that you answered?
No, I think you answered it. Thank you very much. And the second question was about the blind, the Petercamat 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?
Yes. We published a press release communication earlier during the quarter relating to Piraparumata 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 very little effect on fall rates by placebo. But that's what we know.
And there isn't very much more to say. In our Phase 2a study, for instance, we had no change in the scales that were used to address falls in that study. While we had a significant movement in the scale for the treatment arm in the Phase 2a study. If that is reproduced, we don't know.
Got it. And a final question was about you mentioned also, Nicolas, the disabling dyskinesia as potential in Europe. Can you expand on that patient population and the need and so on?
The patient population with disabling dyskinesia is roughly half of all patients who have dyskinesia. So it represents roughly 15% of all Parkinson's, 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 is used at low doses, not very effective. But we are targeting another population with messed up the arm, a larger population with messed up the arm in Europe as we are in the U.
S. And this is a really important that 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 that 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, DBS electrical devices in the brain. And here we can actually squeeze in mesdopodam in between those strategies, which is a really important positioning of the product.
Sounds very interesting. Thank you very much. That's all from me.
Thank you.
Thank you so much, Frederic Tuur of Redeye. And we are ready to move on to Alexander Kremer of ABG Sundal Collier. Please go ahead with your questions.
Good morning, and thank you for taking my questions. I have 2 actually probably for Nicholas, 1 on 5757 and the 1 on a pre reprimand, maybe to start with the 757 question. I mean, now you're running to 757 phase 1 studies. And my question here is why was it decided to run another phase 1 in elderly patients instead of kind of combining it with the phase 1 study that you have already started previously? Was this sort of a request from MSRD or was it more of a decision to divide the costs between the Michael J.
Fox Foundation and MSRD to that study?
Okay. Okay. 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's 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. And that has to do with the regulatory pathways for those two populations.
Okay. I see. Is there any other differences between these 2 Phase 1 studies?
Not really. The single ascending doses, both in the healthy younger and healthy elderly. We are not conducting a MAD study in the elderly.
Okay, good. Then my second question is on Pirapimat. I mean, so recently, I mean, you released that you have more than 100 patients in that study now, which is a bit a bit of wake. I mean, before, I mean, in previous quarterly calls, you mentioned that you're expecting around a patient size of around 120 patients, which means that 25% reduction. Could you be a little bit more precise on how many patients you have in this study?
And if, if this is, if this is like an additional reduction?
No, it's not an additional reduction. We have not, 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 above, clearly above 100 patients in the study. And 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, 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.
Okay. Thank you.
Thank you.
All right. Was that all from you, Alexander?
Yes. That's all from my side. Thank you.
Okay. Thank you for participating. And after that, we will move on to Aaron Atger of Edison Group. Please, Aaron, go ahead with your questions.
Good morning. Thanks very much for taking my questions. Looking at the new market research for Ms. Dopetam, you stated that the planned Phase III design aligns with the desires of healthcare 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?
Do you want to take that on 7 plus? I think
you're a bit Yeah. Can you repeat the specific question once again?
Sure. So in the market research form as Dopetam, it was stated that the planned Phase 3 design aligns with the desires of health care funders. I was just looking for a little bit more color on that.
Yes, it has to do with the length of the study, 3 month studies is, of course, what they also want to see. And then the open label extension safety portion of it is what they want to see. And 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. And a deeper dive into that actually is because when they see the protocols for our trials, they acknowledge that we are looking at disabling dyskinesia in our trials. And that is what makes them excited.
And 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.
That's helpful. Thanks very much. Another quick question on mesdopetam. Christina 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?
Of course, you would need further clinical studies. And this is something we've had in our pipeline since we started the programme, basically. The drug behaves as an antidiskinetic 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. And we have a protocol for it. And 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 mestopotom in the Parkinson population.
Excellent. Thanks very much. One more question, if I may, on IRL 757. 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?
Currently, what we are going to do is we are running 2 separate studies then in the different two 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 2 and Phase 3.
Thank you very much. All right. Thank you so much. Aaron Atkin of Edison Group. And I will raise one question from our viewers.
Matthias Olsson asks, earlier you expected a Phase III start for Mastopetan in Q4 'twenty four or Q1 2025, and now it's just 2025. Could you please elaborate a bit on this change?
Sure. Yes. So when we had that earlier on the slide and expecting to have the end of this year or early next year, we had assumed that the PET 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, and 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 healthcare 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.
Okay. Thank you, Kristina. And that will conclude this broadcast. So first of all, thank you so much to the executive team of IR Lab. Thank you.
Thank you so much for listening.
And 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.