IRLAB Therapeutics AB (publ)

Welcome to the quarterly presentation of the fourth quarter and the year-end results by research company iLab Therapeutics. Presenting today is CEO Kristina Torfgaard, Executive Vice President R&D Nicholas Waters and CFO Viktor Sivic. After the presentation we will be given a Q&A with participating equity analysts and viewers can ask their questions in the live chat. Hello and welcome Kristina Torfgaard.

Hello, good morning.

Please go ahead with your presentation and I will be back for the Q&A.

Thanks. So can we have the first slide and the next one, please? So today's agenda, I will introduce and take you through the news of this period and beyond that. That will be followed up by the R&D update from Nicholas Waters, EVP, head of R&D. And then Victor Sieverts will continue with the financials. And I will have some concluding words and also inform you a little bit about the future. So the next slide, please. So I would just like to remind you that IOLAB, we are developing new, innovative and better medicines for treating Parkinson's disease for all the different stages. On this slide, you can see the core and the main symptoms that the patients or the individuals are experiencing at the time when they get the disease. However, if we have another click on this slide, you can see that there are a number of different symptoms that are developed during the progress of the disease. And on the right side there, you can see we have five candidate drugs. They are all first in class and they are unique in that sense. And with those, you can see that we are aiming to treat all the different symptoms that can be experienced during the disease. So the next slide. So I will take you through the key highlights during this period and after. So we received 2.5 million US dollar from MSRD Uzuka earlier this year, or sorry, that was the last year in Q4. And that was in conjunction with that we started the first study in elderly healthy adults. And this was the first juicing that experienced in October. We have also received positive results from two studies. One is first in men's study in healthy volunteers. And the second one was the older adults that was given this kind of date drug. And we have excellent results. that Nicolas will talk more about. So we are progressing 757 according to plan. And this candidate is fully funded through proof of concept, which is at the stage when we are in clinical stage and treating patients to get data generated from patient studies. We received and had all the patients completed the phase 2b study in peripamat. the REACT study. And earlier this year, also the patients completed the study, the full treatment. We are also expecting to get the first top line data this quarter, which is very exciting for us. So this means that we are continuing towards the readout as planned. For Mestopitan, we did a payer research and that we looked into to get confirmation about that, the willingness to have payers to pay for this and get the reimbursement. And we also have very good positive outcome from this payer research. So this strengthen our commercial opportunity for Mestopitan. So the next slide, I will take you through more in detail. If we focus on Mestopetan, we had ongoing during Q4 regulatory interactions. So we met with both Portugal and Germany and had regulatory meetings there. We got very positive feedback and had a consensus regarding the key aspects of the phase three programme. So this is also in line with the feedback we got earlier last year with the FDA. As I said, we did a market and payer research, and this confirmed that the healthcare payers can see the potential with Mestopitan, and there is a willingness to pay for this candidate. And we can see that both for the US and in Europe, which is remarkable, I would say. Very good. We also presented data from a meta-analysis that we did. We did a meta-analysis on the two studies, phase two studies that we have performed on Mestapetone. And the data there showed a significant clinical meaningful anti-dyskinetic effect, which we also presented at the conference in the US. So we are very proud of this data. And this is a well-known and a very experienced and very good conference that we attended. Very early this year, we also announced that we received a waiver from EMA regarding a pediatric program. This means that we don't need to perform pediatric studies that could have been very, very, I would say, take long time and very expensive. So we are very pleased with that outcome. we can move ahead as planned. To the next slide, please. For peripamat, the last patients completed the full treatment period, and we are in line with the expected readout during this quarter. So it's going to be very exciting in a couple of weeks time. For 757, our third candidate in clinical stage, We have completed two phase two studies, phase one studies, sorry, both in healthy volunteers and in the adults, older, healthy older adults with excellent data. And this, all these pharmacokinetic and safety data support to continue development with 757 into clinical studies, I would say, with patients. So if we take next slide. During this period, we have also been now presented for investors about the company, our strategy and pipeline. And you can see that we have participated both meetings at RedEye Biostock, AVGS and at Insight Direct Dagen. And this can be found on our website. So the next slide, please. And now I would like to hand over to Nicholas Waters to take you through the R&D update.

Thank you, Kristina, and thank you all for listening today. Next slide. Go on, next slide, please. I'll talk a few words about Mestöpeton. First, this is our most advanced project to date. This represents a first-in-class and novel mechanism, and these are very important aspects of a development program for a new indication with a huge unmet medical need. The drug acts as a dopamine D3 receptor antagonist. The D3 receptor is one of the known dopamine receptors in the brain controlling motor function. We have worked a lot around the IPR with this product, And I'll come back to that soon, but we have now, we are close to expanding the market exclusivity with this, with new patents. The lead indication is levodopa induced dyskinesia, as we've been talking about for a couple of years now. In addition to that, we have generated data, preclinical data in-house, but also together with partners, academic partners, independent such, to investigate other types of indications, such as psychosis in Parkinson's disease. I'll come back to that. Next, please. So, when it comes to the LIDS programme for mestopetam, as Kristina alluded to, we have talked to regulatory bodies or organisations in the US, the FDA, of course, and we reported on that during the spring. A very, very productive meeting with the FDA. We followed up with meetings with the BfArM, the German competent authority, and Infarmed, the counterpart in Portugal. That was to, in principle, get feedback from those that are considered very knowledgeable in Parkinson's in Europe concerning our programme. And as Kristina mentioned, we have received basically confirmation of the same strategy as the FDA proposed to us. Now we are also waiting to incorporate the advice from EMA, which we will have soon, hopefully, into the programme. So that's the regulatory aspects. The FDA, local regulatory bodies in Europe, and finally EMA. In conjunction with that, we have also talked to paying organisations in the US and in Europe. And the interesting aspect of coming out from those discussions is, of course, that all organizations, paying organizations, US and EU, they see that there is an unmet medical need. They like the profile of mestopetam, that is antidiskinetic without any side effects at the optimal treatment doses. And then they also say that, which is to some extent surprising, that we can probably have a similar price in Europe as we get in the US. That is what we have been advised by these payer organisations. And this is a little bit off in terms of what is expected. Normally, there is a difference between the US and Europe, a factor of two, factor of four, perhaps, sometimes even larger. But here we see that we have an opportunity also in Europe to get a significant price. We have worked hard on developing an IPR and last year we got a patent approved in Europe, a composition of matter, a new composition of matter patent approved in Europe. We're now processing that patent application in the US and we have very, very firm belief that we will get that approved. If and when we have both of these patent families or patents approved, the European one and the US one, we have exclusivity a fair bit into the 2040s in both regions, which means that if we launch this in a reasonable time, complete the phase three programme and launch this programme, this drug, we can actually achieve the maximum allowed up to 14 years of exclusivity on the market. This is also almost not unheard of in the industry. Today, the average exclusivity time based on patents is usually somewhere between six and nine years. So that, of course, adds value to the program, a lot of value, actually. In addition to that, external laboratories, academics such, have been investigating mestopetam in various types of preclinical models. One group published a paper describing the anti-dyskinetic effect of mestopetam recently. What was very interesting with that work, which is cited here in the presentation, you will find the presentation on our website after the presentation today. You can click that link. There is a very interesting passage and data set in that publication where the scientists there, they see that treating mestopetone, treating Parkinsonian animals with mestopetone, actually increases the number of synapses in the brain. So there is a buildup of synaptic connections after treatment with Mestopatone in this rodent model of Parkinson's disease, which indicates that this Mestopatone actually has potential for disease modification. In addition to that, we have been working together with a distinguished research group here in Sweden, Professor Per Pettersson and his team have developed a very, very, at Lund and Umeå, they have developed a very advanced model for exploring psychosis in models of PD. And here in this paper, they compare contemporary used drugs for psychosis in Parkinson's disease with mestopetam in this model, showing that mestopetam has a high potential as an antipsychotic via a different mechanism than the current ones. Interesting papers for those who like preclinical research as well. Next, please. Piripimat is, of course, in everybody's focus right now. We have communicated that we have completed the recruitment for the study. Can we have the next slide, please? Also here, we have a first-in-class drug, novel mechanism, not seen before. And the patent estate also allows for exclusivity into the 40s around pyripimat. Next. Focusing on falls. There are a couple of aspects of falls which are quite interesting, not the least the biological or medical aspects of it, but also the commercial and monetary aspects of falls. About half of all patients with Parkinson's fall, up to between one or two times a year, up to 100 times a month, actually. So it's the number one falling disease on Earth. There has been reports from CDC, which are a couple of years old now, so those numbers may have increased a lot, informing that the cost for one fall is around $30,000 per patient. However, more recent documentation around the cost of falling in general, if one looks at the population 65 or older in the US, it can be calculated that The US Medicare system, Medicaid system, I should say, spends around $80 billion to treat falls, non-fatal falls in the US. So it's a huge market. And if one can just reduce that just a little bit, it would be a fantastic gain for society. Coming to the status of the program, we have announced that we had the last patient last visit in January this year, which means that our CRO is now working up all the data, quality checking the data, moving towards what is called database lock. And after the database lock, there is a few activities leading to the top line results. So our prediction is that we will have the top line results within Q1 this year still. What we have seen so far in the study is that, and we've communicated during the fall, is that we see a very high baseline rate of falling in this population that we have studied. We also see a stable falling rate during the one month running period in this trial. Then patients are randomized, and we've published also that during the randomized phase of the trial, the three-month treatment period, either with placebo or a low or a high dose of pyroprimate, aggregated, we see a reduction of falls in the study, which means that to some extent, participating in this trial at least leads to less falling. And the interesting thing will be now when we apply the code to the data and see if there is actually an effect of drug. That will be really, really exciting. And this will happen now during Q1. Next, please. 757. Next, please. This is a program. directed towards apathy in Parkinson's disease and neurological disorder in general. We are focusing right now on developing it within PD as a first shot. PD patients, they experience or they display apathy at a high rate on a daily basis. This is an unmet need. There is no treatment for it right now. And 757 fits very well into some of the general hypothesis of the genesis of apathy, corticostratal deficiency, basically. And what we have so far experienced with the drug is quite remarkable. We have a drug here which comes out of our ISP discovery system. The third that we bring to the clinic We've taken it quite rapidly into a quite substantial phase one programme, including single ascending doses in healthy volunteers. We have multiple ascending doses, which is ongoing, that is treating for two weeks. And then we have also looked at elderly patients with this drug. The outcome of the studies, we've given some information publicly already, but the general feeling we have around this product is that it has a very stable pharmacokinetic profile, very safe, very little adverse event in these studies, which means that this is a truly viable product to bring forward into the next step, which will be a patient trial. And we hope to be able to start that study this year. After the summer, basically. Next, please. So that programme is moving rapidly ahead. I've been through this information here with the successful completion of all these different parts of the phase one programme. One thing I didn't mention is that we have actually completed the SAD part now. last dosing has been done we're waiting for the final data from that but it looks very very promising from a therapeutic perspective and from a usefulness perspective as a drug next please And we have our two preclinical programs, 942 and 1117. 942 for cognitive deficits in Parkinson's disease and other neurological disorders. And then 1117, which is a quite unique proposition from our discovery unit. Next, please. So we're looking at quite large differences. large populations here which means that there are high demands on the quality of these drugs 942 and 1117 and so far both of them have proven to have those qualities necessary to be used in larger populations both of these assets are in pre-clinical development right now with the focus on the cmc developing the production methodology and producing drug for ind enabling studies Next, please. In more detail, 942, addressing cognitive deficits, which is one of the biggest problems in Parkinson's disease, according to recent studies interviewing 25 to 30,000 patients, studies performed by the Michael J. Fox Foundation, where cognitive deficits are one of the biggest problems for the patients and for their caregivers. So this is an important task to improve their quality of life as well. Also here we have potential for symptomatic relief, of course, but from a neurobiological perspective, it's also possible for disease modification. Next, please. We are currently developing the CMC activities, working up the method for large scale synthesis of 942, but also the drug product that we will use in phase one later on. We are looking at, hopefully we can initiate IND enabling studies during this year. Next, please. 11.17, as I said, is a quite remarkable proposition from the laboratory here, representing a totally new technology to treat the basic symptoms of Parkinson's disease. That means the symptoms that today is treated mainly by levodopa and a few add-on medications. Levodopa has been used since the 60s, we all know that. Levodopa has fantastic effects, we know that, but it comes with a price in terms of sensation to the treatment, which leads to fluctuation in response and leads to dyskinesia and a lot of other complications such as psychosis, et cetera. So what we are trying to do here is to develop a drug which has a long effect period And here we can show from rodent studies we've done that we have activation of motor function in models of Parkinson's disease over 24 hours after one dose. This is unique. Next, please. So. Besides the long-acting effect, we also have corroborating PK data supporting that, that we have the drug actually in the brain during that period or in circulation during that period. We also see that this comes without inducing any of the complications we see with levodopa. We published Some of this work already in terms of posters, which can be found on our web page. CMC development is ongoing. We intend to start the IND enabling studies as soon as possible. Patent estate wise, we have also here opportunity to have exclusivity well into the 2040s with this program. Next, please. So I'll hand over to Victor to talk a little bit about our finances.

Thank you, Niklas. So we can take the next slide, please. Well, the cash position is about 67 million at year end. 17 of those are earmarked for activities that we do together with MJFF and MSRD in the 757 programme. and has already been paid out to us and will be used for activities in that program. We can see in the middle graph that the activity in the company is still very high, and especially the cost for IRL77 is increasing, which is good because that means that there is a lot of activity in that program. And again, fully financed by MSRD, and MJFF at the moment. Our own cost, apart from 757, continues to decrease and is now well below 30 million kroner for the fourth quarter, indicating some cost consciousness. We can also see that we still have quite a lot of activity in the external clinical program, which is the period model study, the dark gray part of the bar. And that is a lot of the cost that we see in the quarter. The headcount remains stable, so we can see that the personnel cost is also quite stable at around 10 million per quarter. The mid gray area is the external activities that we have apart from the clinical costs. So that is talk studies. It's our premises and offices and laboratories and all that. So we're trying to keep that at the sound level at the moment. Next, please. This is just a summary of the figures where we see that net sales has increased quite dramatically since last year. And that is, of course, due to the payments from MSRD and MJFF. So it's partly upfront payments and milestone payments and partly the cost coverage for the 757 programme that lies in those figures. And sorry, this is only money that we received from Otsuka. The MJFF is on another line in the P&L. The operating profit we can see is a lot lower. The loss is a lot lower than last year. And that is, of course, due to that we last year had more clinical activities ongoing. which can also be seen in the cash flow from the operating activities. So with those words, I'll leave back to Christine.

I think we probably just mentioned about our equity analysts that we have with us today. From REDA, it's Fredrik Thor. From ABG Sundal Collier, it's Alexander Kramer. And it's from Edison, it's Aaron Atkar. And you are going to ask us questions after my summary and concluding remarks. So next slide, please. Next slide. So our pipeline is stronger than ever. And we dare to say that we have a world leading portfolio in developing programs for Parkinson's disease. With Mestopetone now progressing and where we have projected to start a phase three program during this coming year, 2025, where we also have then also, in addition to the leads indication, the opportunity to move into psychosis. For Piripimat, it's exciting times as we very soon will receive the top line data from the fall study, react study. But also to remind you that we also have the opportunity to move broader also into dementia with this candidate. For 757, everything is progressing according to plan with very good data. We are looking forward to move on into patient study later in this year. And 942 and 1117, moving them closer to phase one studies. So the next slide, just to remind you about the key highlights that we had during the year that are the 757. I would say that we have had successes there with our first studies and we are progressing according to plan there with moving into proof of concept. studies, and then we have the top line data coming up. And also that we are very pleased with the payer research that we have got information about the willingness to pay for Mestaputan in both US and Europe. So this is really a commercial opportunity for us. So next slide. So of course, we are also working very intensively with the business development. And during the year, we have, I would say, increased awareness of the company. We have continuously and frequent discussions with potential partners. And alongside this, we have been evaluated and are evaluating potential deals and different types of, I would say, deals. So after the successful discussions, completion of the collaboration and the deal we had with MSRD Utsukia. We are now focusing on the Mesto Beton. Continue on that, but also focus is on Pirepamat, of course, now, which is going to be exciting. It's a huge interest there. So the next slide. So this summarizes the possibilities and opportunities we have coming up now where we can increase the value of the company and the candidate drugs. For Mestopatone, we have the BD activities and the initiation of phase three program. Peripamat, top line data coming up and the BD activities ongoing there as well. 757 to complete the phase one program. and initiate what we called a signal finding study in patients and the preclinical program to start up then phase one studies. So with that, I will hand back to you, Mattias.

Thank you so much. Thank you, Kristina. And I'll soon unleash the equity analyst. But first, I want to remind the viewers that they can ask their questions in the live chat. And by that, it's time to hand over to Aaron Atker of Edison. Please go ahead with your questions, Aaron.

Hi there. Good morning. Thanks very much for taking my questions. I'm just looking at the way that you received from the EMA for the PDF. From the FDA. Could you just provide a bit more color on what this means in terms of time and resources? This will save for the company.

So this is very typical of something that other companies need to do for areas where there are diseases that you can see also in children. But as we don't need to perform any more, any studies at all for children, this will absolutely be good for us and the resources will be saved. We haven't really calculated on this, to be honest, because we were very aware of that this was likely to happen. But that's good for us, good information.

Excellent. And also for mesdopotam, you mentioned the potential for similar pricing in Europe as would be in the US, which isn't super common to my understanding. Could you just provide a bit more context on why that might be the case with this drug candidate?

I hand over to Nicolaas there.

Just to fill in a few words on the paediatric waiver, we also have one in the US. And this, of course, is a big saving. For any company getting a paediatric waiver, that means a lot of money. You can compare it with the cost of a traditional Parkinson's study for us as a saving. There are actually paediatric patients with Parkinson's, but they are so rare that it will be almost impossible to do a controlled study. And that is recognised by authorities. Coming back to the second question, can you repeat the second question, please?

Sure. So for Mesdopotam, you mentioned the potential for similar pricing in Europe as the US. Just wondering if we can get a bit more description as to why that might be the case.

US has its own system of pricing, etc. And there is lots of strategies how to get the right price for a product to actually get the most out of it. In Europe, it's a little bit different. You are mandated a price and all countries have different strategies. However, with the inclusion criteria we have in the, we've had in the phase two studies for mestopetone, we are targeting a population in Europe, which are called patients with disabling dyskinesia. And these represent roughly 15% of all diagnosed Parkinson's patients. The total population cohort of patients with dyskinesia is around 30%. So it narrows down the band a little bit in terms of patient population. However, there is no treatment for that. And there is no use of any drugs for that in Europe. So the advice we have gotten from the payers during the pay research exercise in Europe is to stick with the inclusion criteria we've had in the phase two studies, which is obvious, we will do that anyway. But that actually allows us to have a more deep discussion on the pricing concerning this product in Europe. So it actually addresses a fully unmet medical need also in Europe. So that's the reason. And it's a very interesting discovery.

Excellent. Thank you very much. Just one more question from me, if I may. I'm turning now to Perepimat. We're looking forward to the top line results from the Phase 2b study. Just curious to hear what the next steps for the programme might be in terms of progressing to Phase 3. But might that be something that lab progresses independently or would that be contingent on a partner?

Both. First of all, after we have the data, of course, we will have to sit down, understand the data, communicate with you guys directly. And then there is lots of work to do before we can actually start a phase three trial, of course, as it always is. There are regulatory interactions. So during the coming period after the data, there will be a focus on the regulatory interactions to bring this forward into further clinical trials, should we come out with good results. So that's the next step, naturally.

Excellent. Thanks very much. No more questions from me.

Okay. Thank you so much, Aaron Atker of Edison. And now we're moving on to Fredrik Thore at Redeye. Please go ahead, Fredrik.

Yes. Hello and thank you. Yes, you mentioned regarding pre-format that there is a market potential of 80 billion when it comes to falls for elderly patients. And I also was interested in the number of $30,000 per fall as a societal cost. Could you maybe relate these numbers a bit to the potential pricing strategy for pre-format and especially the 30,000 one, how that could be impacted?

First of all, one shouldn't be blinded by these high numbers. They are there. When it comes to falls, there is a plethora of studies, health economic studies, indicating the cost of falls across the globe. This is the number one cost for most countries, actually, or payer systems. They're affected a lot by falls in terms of cost. So when A couple of years back, we did a health economic analysis based on the phase two A data results that we had on peripremat. We did a health economic analysis and we used all the information we could find in the literature, which is relevant to the population we are studying, that is neurological or more specifically Parkinson's patients. And we find that the Treating with pyripamide, assuming a certain quite moderate treatment effect in that study, assuming a moderate treatment effect, we see that we can actually calculate the premium pricing to just keep cost neutrality in the system. And this price would be somewhere in the pricing of the more newly introduced drugs within neurology. That's how far we can go in advising. That's what we think based on the analysis we've done. Got it. This is not a promise, this is projections.

Of course. And the next question, you mentioned and previously mentioned that the reduction of falls by 20 to 25% would be meaningful. I was just wondering, How binary is this or how continuous is this 25%, for example? Like, would it be 17, 18? Would that also be good, but just not as good? Or would it need to be above a certain threshold?

There is no guidance on that. This is a young science, I would say, looking at falling specifically in Parkinson's. The 20-25% reduction comes from an interview panel with lots of physicians across the globe that was published a couple of years back. You can find the link to it in our presentation. The authors find that most physicians view even without the treatment, we should mention that, without the treatment, they view the reduction from four to two falls per month or reduction from 10 to five falls, from 10 to seven and a half falls per month is meaningful for an individual and for the treating physician as well. That is what it is. We all know that when a drug is introduced, when a drug shows to have effect and it's introduced into the patient population, the effect size requirements can change dramatically. So even 10% would perhaps be good, or perhaps 30-35%. That's an open question. But the 2025 is what is found in the literature right now as a guidance. And the guidance there is also helpful for people developing drugs in this space, because it gives us a handle on how to power studies. So it has two-sided, it informs about the minimum clinical important effect, but it also informs about how to design studies, which we have followed.

Got it. And a final question about IRL 757, the top line data that you have presented and mentioned also, I mean, Can you maybe explain a bit more with some more granularity about why the data is good and why it's important in this patient population to have this safety?

First of all, safety tolerability is number one for this patient population. These are sensitive individuals with neurological disorders. So that's number one. And here we have exposed healthy and elderly at rather high doses. in these trials. We don't see any aggregation of adverse events or side effects which could compromise the use of the drug at all. And we also, in combination with that, we also see a very, very nice homokinetic property. That is how it's distributed in the body and how long it stays in the body. So we are looking at, from our perspective, one of the best drugs from that perspective that we have made.

Sounds promising. Thank you very much. Thank you.

Thank you, Fredrik Thor. And we move on to Alexander Kramer of ABG Sundahl Collier. Please go ahead, Alexander.

Good morning, and thank you for taking my questions. I have two, one related to 757, maybe a follow-up question, a very short one. I'm planning to share some data, some phase one data at some point this year, for example, at a conference or in a certificate journal?

Yes, absolutely. That's good that you bring that up. We're planning to present this data on upcoming conferences. So, yeah.

All right, great. And will it be in H1 or more like later this year?

When H1? Oh, you mean the first quarter? I assume that's going to be fairly soon, yes, during the first quarter.

All right, all right, great. And my second question is on 942. I mean, you have made quite some progress, of course, with 757 in the past month. And also, of course, 942 is advancing into the clinic. And as I remember, for 942, you had a collaboration agreement there also with MSRD back in 2023. Is it something that MSRD is looking at at 942? Is there a potential that MSRD might decide to also join in for 942 to move this one into the clinic and also participate in terms of costs and revenue?

I'll hand over to Nicolaas to be asking that.

We had a collaboration with 757 942 a couple of years back on both of those with MSRD. were evaluating we decided to move forward with 757 together with them 942 is ours for now but of course we are looking into different opportunities with 942 as well in terms of business development MSRD could well be one of those but there are others okay great thank you thank you very much

Thank you, Alexander. And there are a few questions from the viewers and I will try and smash them together. There are a few regarding Mastopaton claiming due to the fact that Ipsen returned the molecule and but there has been very positive comments from Mr. Patan. But how come there are no deals yet or even letter of intents?

So I will say there is a couple of pieces that they have been waiting for. It's the regulatory authorities feedback. We are still waiting for the EMA response on the scientific device. and then also the patent in the US, the SALT patent there. But we believe with those pieces in place that there will be moving forward. But I also would like to remind you that comparing Last year with the year before, there have been much less of deals in the pharma industry. So it's not only that it has been a bit slow progress for us, it's in general what has been seen.

Thank you. And a question on Pirepamat, and it follows. The market's verdict on success or failure on the top line result will be a very thin line under or above P0.50. My guess is that your potential partners will not see it in the same way.

Do I hand over to Niklas there?

That's a very insightful comment, I would say. Of course, 005 is what everybody looks at. However, this is a phase two study. It's a study designed for us to collect as much data as possible to make informed decisions about the next step. So it's not until you get to phase three that you have to prove anything in terms of significance at various significance levels. So the way we will see this data is, of course, it will be nice with a significant primary endpoint. However, we are looking at a lot of other aspects of this. Is there a dose response? Is there a good effect at low doses as well as high doses? There are lots of things to look at in this data. So from a drug development point of view, the data we've generated will be helpful independent of the p-value. We can come to the conclusion that this is a viable program, and so will also potential partners, irrespective of the 005 level. But the market, which you all act upon, and we all act upon, is very focused on the 005 aspect of a treatment, which is not telling the full story, I would say.

Okay, thank you. And I have one last questions to Christina, I guess. You're waiting for the phase two B result for Pirepamat. How do you prepare in order to receive the top line results?

It's a very good question. So what we Of course, we have been looking into what kind of a top line data we can expect. And we also looking into different scenarios. So we have been a little bit of preparation before we get those data. But I would say that's in general what we do. So it's going to be exciting. And we think that we are well prepared by doing this exercise internally.

Thank you. And that was all the questions for today. So thank you, members of the executive team of Ireland Therapeutics.

Thank you very much for your interest and for attending here.

Thank you. And we are already looking forward to the Q1 report in about three months. And of course, the results in the PeriPermat Phase 2b study in the present quarter. And to all the viewers, thank you for joining us.