Welcome to the quarterly presentation of the fourth quarter and the year end results by research company, IRLAB Therapeutics. Presenting today is CEO, Kristina Torfgaard Executive Vice President, R and D, Nicholas Waters and CFO, Victor Sievert. After the presentation, we will be giving a Q and A with participating equity analysts, and viewer 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 and A. Thanks.
So can we have the first slide 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 and D update from Nicholas Waters, EVP Head of R and D, and then Victor Silvets 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 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 experienced 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. 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.
With those, you can see that we can, 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 2,500,000.0 US dollar from MSRD earlier this year, or sorry, that was last year in Q4. That was in conjunction with that.
We started the first study in elderly, healthy adults. This was the first dose in that experience in October. We have also received positive results from two studies. One is a first in men's study in healthy volunteers and the second one was the older adults that was given this candidate track. We have excellent results that Nicholas will talk more about.
We are progressing seven fifty seven 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 Paripomat, the REACT study. 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 Mestopetan, we did a payer research and there we are looking to get confirmation about that willingness to have payers to pay for this and get the reimbursement. And we also have very good positive outcome from this pager research. So this strengthened our commercial opportunity for mestopecan. So the next slide I will take you through more in detail. If we focus on Mestopetan, we had ongoing, during q four, 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 program. 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 mestopecan and there is a willingness to pay for this candidate. 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 mestopetone. 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 those data.
And this is a well known and, has seen 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 patient 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 seven fifty seven, our third candidate in clinical stage, we have completed two phase two studies, phase one studies, sorry, both in health volunteers and in the adults, older, healthy older adults with excellent data. And all these pharmacokinetic and safety data support to continue development with seven fifty seven 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, ABGS, 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 Nikolas Waters to take you through the R and D update.
Thank you, Christina. And thank you all for listening today. Next slide. Go on. Next slide, please.
I'll talk a few words about Mesto Petam. 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 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 disease. I'll come back to that. Next, please. So, when it comes to the, the LIDS program for Mr. Putnam, as Christine alluded to, we have talked to regulatory bodies or organizations 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 B pharm, the German competent authority, and INFORMED, the counterpart in Portugal. And that was to, in principle, get feedback from those that are considered very knowledgeable in Parkinson in Europe concerning our program. And as Christina 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 program. So that's the regulatory aspects. The FDA, local regulatory bodies in Europe, and, finally, EMA. In in conjunction with that, we have also talked to paying organizations in The US and in Europe. And the interesting aspect of, coming out from those discussion is, of course, that all organizations, paying organizations, US and EU, they see that there is an an unmet medical need.
They like the profile of mestopotom that is antidyskinetic 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 organizations. And this is a little bit off, in terms of what what is expected. Normally, there is a 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 a significant price. And then we have worked hard on developing 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 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, both patents approved, the European one and the US One, we have exclusivity a fair bit into the 2040s, for both, in both regions.
Which means that if we launch this in a reasonable time, complete the phase three program and launch this program, this drug, we can actually achieve the maximum allowed up to fourteen 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 adds value to the program. A lot of value, actually.
In addition to that, external laboratories, academics such, have been investigating, mesto pothon in various types of preclinical models. One group published a paper describing the antidyskinetic effect of mastopetone recently. What was very interesting with that work which is cited here in the presentation, you will find the presentation on our web website after the presentation today. You can click that link. There is very interesting passage and data set in that publication where the scientists there, they see that treating mestopotom, treating Parkinsonian animals with mestopotom actually increases the number of synapses in the brain.
So there is a buildup of synaptic connections after treatment with the with the mestopotom in in this rodent model of Parkinson disease, which indicates that this mestopotom 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 Perteschon and his team have developed a very, very, at London, 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 Mesto Bautam in this model showing that Mesto Bautam has a high potential as an antipsychotic via different mechanism than the current ones. Interesting papers for those who like preclinical research as well.
Next, please. Period MART is, of course, in everybody's focus right now. We have communicated that we have completed the recruitment of the for the study. Can we have 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 period per month. 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 the 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 $80,000,000,000 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 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 projection is that we will have the top line results within q one, 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 period MARD, 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 an actual effect of drug.
That will be really really exciting. And this will happen now during q1. Next, please. July. Next, please.
This is a program directed towards apathy in Parkinson 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 on a daily basis. This is an unmet need. There is no treatment for it, right now.
And seven fifty seven fits, very well into the some of the general hypothesis of the genesis of, apathy. A corticosteratal 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 develop discovery system. The third, that we bring to the clinic, we've taken it quite rapidly into a quite substantial phase one program, 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 in with this drug. And the outcome of the studies, we've given some information in public here already. But the general feeling we have around this product is that it has a very, 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 program is moving rapidly ahead. I've been through this information here with a successful completion of all these different parts of the phase one program.
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 11 17. Nine forty two for cognitive deficits in Parkinson disease and other neurological disorders. And then eleven seventeen, which is a quite unique proposition from our, discovery unit. Next, please. So we're looking at quite large large populations here, which means that there are high demands on the quality of these drugs, nine forty two and eleven seventeen.
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 preclinical development right now with a focus on the CMC developing the production methodology and producing drug for IND enabling studies. Next, please. In more detail, nine forty two addressing cognitive deficits, which is one of the biggest problems in Parkinson disease according to recent studies, interviewing twenty five to thirty thousand patients. Studies performed by 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 working up the method for a large scale synthesis of nine forty two 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 disease. That means the symptoms that today is treated mainly by levodopa and a few add on medications.
Levodopa has been used since the sixties. 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, etcetera.
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 disease over twenty four hours after one dose. This is unique. Next, please. So, besides the long acting effect, we also, are corroborating PK data supporting that that we have the drug actually in the brain during that period or in the 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 67,000,000 at year end. 17 of those are earmarked for activities that we do together with MJFF and MSRD in the seven fifty seven program, 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 RL77 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 costs apart from $7.57 continues to decrease and is now well below 30,000,000 kronor 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 pyrid mod study, the dark gray part of the bar. So, 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 10,000,000 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 a 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, to the payments from MSRD and MJFF. So it's partly, upfront payments and milestone payments, and partly the cost coverage for the $7.57 program 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 and 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, to that we last year had more clinical activities, ongoing. Which is can also be seen in the cash flow from the operating activities. So with those words, I leave back to Kristine.
I think we probably just mentioned about our equity analysts that we have with us together. From Reda, it's Frederick Tuur. From ABG Sundal Collier, it's Alexander Kramer. And it's from Edison, it's Aaron Atgar. 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 disease. With mestopecan, 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 Piripemat, it's exciting times as we very soon will receive the top line data from the full study, RACT study. But also to remind you that we also have the opportunity to move broader also into dementia with this candidate. For July, 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 September and 11/17, 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 July. 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 Mestepotan 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 success, the full completion of the collaboration and the deal we had with MSRD Otsukja. We are now focusing on the Mesto Petain, continue on that, but also focuses on Pirepimat, 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 Mesopotam, 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. Seven fifty seven to complete the phase one program and initiate what we called 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, Matthias.
Thank you so much. Thank you, Christina. And it's I'll soon unleash the equity analyst. But first, I want to remind the viewers that they can ask their
Thanks very much for taking my questions. Just looking at the waiver you received from the EMA for the pediatrician and the FDA, for mizdokotan, 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 studies at all for children this will absolutely be good for us and the resources will be safe. 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 Mesdopetam, 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 Nicolas there.
Yeah. Just to fill in a few words on the pediatric waiver, we also have one in The US, and this, of course, is a big saving. For any company getting a pediatric waiver, that means a lot of money. You can just, you can compare it with the cost of a traditional Parkinson's study for us as a saving. There are actually pediatric patients with Parkinson's but they are so rare that it will be almost impossible to do a controlled study and that is recognized by authorities.
Coming back to the second question, can you repeat the second question, please?
Sure. So, for Mr. Potam, 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? Yes. US has its own system of pricing, etcetera, 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 this represents roughly fifteen percent of all diagnosed Parkinson patients. The total cohort of patients with dyskinesia is around thirty percent, 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 payer 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. 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 program might be in terms of progressing to Phase three, but might that be something that 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 for me.
Okay. Thank you so much, Aaron Atker of Edison. And now we're moving on to Frederic Tore at Redeye. Please go ahead, Frederic.
Yes. Hello and thank you. Yes, you mentioned regarding Plymouth Mart that there is a market potential of SEK 80,000,000,000 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 Piriforme and especially the 30,001, how that could be impacted if you have the calls?
Yeah. 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 2a data results that we had on period one. 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 patients. And we find that the treating with pyrid malts, 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. 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 next question, you mentioned and I 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 seventeen, eighteen? Would that also be good, but just not as good? Or would it need to be above a certain threshold to
There is no guidance on that. This is a young science, I would say, looking at falling specifically in Parkinson's. The twenty to twenty five percent 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 the literature in our presentation. The authors find that most physicians view, even without the treatment, we should mention that, without the treatment, they view a reduction from four to two folds per month or reduction from 10 to five folds, from 10 to 7.5 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 ten percent would perhaps be good or perhaps thirty, thirty five. 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, 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 seven fifty seven, 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 pharmacokinetic 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, Frederik Thor. And we move on to Alexander Kramer of ABG Sundal Collier. Please go ahead, Alexander.
Good morning and thank you for taking my questions. I have two, one related to July, maybe a follow-up question, a very short one. Are you planning to share some data, some Phase one data at some point this year, for example, at a conference or a scientific journal?
Yes, absolutely. That's good that you bring that up. We're planning to present these data on upcoming conferences. So, yeah.
Alright. Great. And will it be in H1 or more later this year?
When H1 oh, you mean in the first quarter? I assume that's gonna be fairly soon. Yes. During the first quarter.
Alright. Alright. Great. And my second question is on September '2. I mean, you have made quite some progress, of course, with seven fifty seven in the past month.
And also, of course, nine forty two is advancing into the clinic. And, as I remember for September, you had a collaboration agreement there also with MSRD back in 2023. Is this something that MSRD is looking at September if there is a potential that MSRD might decide to also join in for September to move this one into the clinic and also participate in terms of costs and revenue?
So I hand over to Nicolas to bring us on that.
We had a collaboration with seven fifty seven-nine forty two, a couple years back on both of those with MSRD. They were evaluating. We decided to move forward with seven fifty seven together with them. Nine forty two is ours for now. But of course, we are looking into different opportunities with nine forty two as well in terms of business development.
MSRE 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 Mastopetan claiming due to the fact that Ipsen returned the molecule and but there has been very positive comments from Mr. Petan. And but how come there are no deals yet or even letter of intents?
So there were a 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 email response on the scientific device, and then also the patent in The US, the assault 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 not only that it has been a little bit slow progress for us. It's in general what has been seen.
Thank you. And a question on ParepaMat, 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 Der?
That's a very insightful comment, I would say. The, of course, five 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 very significant levels.
So what we, 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 development point of view, 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 five level. But the market, which you all act upon and we all act upon, is very focused on the five aspect of a treatment, which is not telling the full story, I would say.
Okay. Thank you. And I have one last question to Christina, I guess. You were waiting for the Phase IIb result for Pirapimat.
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. We're 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 Aerob 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 Periperamat Phase IIb study in the present quarter. And to all the viewers, thank you for joining us.