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Earnings Call: Q1 2023

May 10, 2023

Speaker 1

Welcome. Research company, IRlab, have released its report for the Q1 in 2023. To present the results, I have on link CEO, Gunnar Olsson Executive Vice President, Nicholas Waters, also Head of Research and Development and CFO, Victor Siewertz. After the presentation, there will be held a Q and A session with Equity Analysts. With that, I'll hand it over to the company.

Please go ahead with your presentation.

Speaker 2

Thank you. Good morning and welcome to this webcast on quarter 1 results for Eelgrav. We take the next slide and the next gen. So today's agenda, Hi, Gunnar Rudsson, I'm the CEO. I will present highlights during the quarter.

Niklas Water, Head of R and D will give you an update on the R and D. Then Victor Silvers, our CFO, will give a financial update. I will come back and do some concluding words to lead in into the Q and A session. So a summary of events during the Q1, if I get the first. IRLab participated in the 6th Neuroscience Innovation Forum in San Francisco, the 1st week of January And this is a Congress running in parallel with the JPMorgan Healthcare Conference.

In the same week, the first week of January, we also nominated a new development candidate, IRM-eleven seventeen. This is a candidate drug that comes from the P003 research project. 11/17 will be developed to be a once daily oral treatment For the cardinal symptoms of Parkinson's disease and that is the tremor, the regenerative and the brand new kinase. However, this will be a medicine that will not have the troublesome fluctuation of effects And the complications that we see with long term levodopa treatment today is mainstay therapy in Parkinson. A medicine with this profile has the potential to replace levodopa in the future.

Next. In mid January, we announced the top line results From the Phase 2b study with mesdopetal in patients with Parkinson can levodopa induced dyskinesia. Even if the study didn't reach statistical significance in the primary endpoint, the study still achieved Its purpose of confirming dose dependent efficacy and it made it possible to select the best dose In the study, clear anti dyskinetic effect throughout the 12 week treatment period. And on the safety and tolerability side, The bestopitant was on par with placebo. The anti dyskinetic effect was achieved Without reducing normal motor function, and this is of course very important.

The profile was further strengthened by a clear reduction in off time. Detailed analysis of the full data set It's still ongoing in collaboration with our partner Ipsen and will aim to present all the data during the year. In mid February, The company announced an update of the portfolio development milestones following an internal assessment of the operational priorities On February 20, me, I was appointed as an interim CEO Following Richard Godtfill's termination, Corla Lende, former Vice Chair, Took over the role as Chairperson of the Board. And Anne Van Isj Johnson elected to lead her role as a board member on the 21st February. As a new chairperson of IRLab, Corla Lambda took over the membership in the nomination committee from me since I am At the end of March, Iglar presented new data regarding our candidates 5757 and the ISP platform at the International Conference on Alzheimer's and Parkinson's Disease And related neurological disorders, at the same conference, The industry symposium was organized by IR Lab on the last of March and the symposium Had the title the management dilemma of progressions and emerging treatment approaches.

The symposium was recorded and it is available through a link on the IRF website. Next, please. Beginning of the year, IR Lab was made aware The recent 20 22 reversal registration document published on April Complete incorrect information that the development and commercialization rights for West Oppenen have been transferred back to Uhlab. This is incorrect and Ipsen corrected the universal registration document on May 4th. Following contact from Ipsen on May 1, a discussion has been initiated with Irlab To mute, you agree the best way forward for the bestopadon program to reach registration And to ensure that bestopiran can be made available to patients with Parkinson's disease.

Next, please. Financial highlights in brief. During the quarter, we had no recorded sales. We had a total operational expenses of €59,500,000 Viktor will go more into detail the reasons why the Uptake of the total operating expenses. We had an operating result of minus €59,500,000 And cash flow from operations, SEK 41,500,000 and cash And cash equivalents at the end of the period amounted to 210,000,000.

The total number of registered shares at the end of the period is just south of 52,000,000. Next, please. So, eLab at the Glance, We are working with pioneering biology. We have the unique USG platform and this is built on Very deep and profound understanding of parking sources is emanating from the region around We have a focused strategy. We provide Therapy to any partisan patient throughout the disease journey.

We have validated the way we work. We have discovered new CVs. We've taken them from CIL D to Phase 2 validation in patients and our first program is We have a good and solid portfolio and I would actually take in my mouth and say that Within the Parkinson space, I think we have a world leading portfolio with 5 unique candidates, All with blockbuster potential and they are all discovered through our disruptive ISP platform. We are an organization positioned for success and we are listed on the top of Stockholm. And with that, I think it's time to move into the R and D update.

So please, Nikolas.

Speaker 3

Thank you, Gunnar, and thank you all for listening today. I will put a few aspects of our development programs as we stand here. Eelab has a profound Brain as an important organ in our bodies. We've been working with that with those issues over the past 4 or 5 decades now together as a team. Eelab, however, has a very strong focus on Parkinson's disease.

And just to initiate the discussion, I wanted to give you some Feedback or some information about the problems in Parkinson's disease. And there is it depends basically on the loss So dopamine neurons, which around 80%, 50% to 80% of all cells of the containing dopamine Are lost and then you get the symptoms. And the symptoms are very clear to a decision. You get tremor, bradykinesia, bradystrophy, shaking, slowness of movement and stiffness. And later on in the development of the disorder, you also get covered with balancing faults.

During the course of the SITs, there are a number of options to treat the SITs available, But all are basically based on the basic treatment with levodopa, which is converted In the brain and thus exerts the effect of the lost dopamine. This is a fantastic Innovation on discovery once upon a time and it helps patients across the globe. However, there are a number of issues which are not treated. Next, please. Next slide, please.

And that is We very well expressed by the patients. And this is a study that has been financed by the Michael J. Fox Foundation, Whether interviewed or collected information from 25,000 people living with Parkinson's disease, that's people having Parkinson's disease. And they are asked which are their biggest problems. And this is something that is really, really important to know when you are focusing on treatments for Parkinson's disease.

And interestingly, one of the most Compelling discoveries, at least to me in this study, is that the patients still have problem with the hallmark symptoms of Parkinson disease, that is body kinesia, the slowness of movement and the tremor, despite the fact that L dopa is available. And to me and to us, that tells what's also been published that patients in general are under treated with levodopa. And that has to do with the risks that are associated with the treatment with levodopa. I'll come back to that. One of the most important factors that came out from this study was that patients have Real problems with falls and balance.

And that is something that we are addressing. This is the biggest issue. It has been rarely talked about in the past 20 years, but there is A surging interest in this aspect of Parkinson's disease now. Then we have the neuropsychiatric symptoms, Which are also compelling to the patients. And that's, of course, psychosis, which is one aspect.

There's also mood swings, apathy, which are important aspects of the neuropsychiatric complications, skin and Parkinson. Next, please. Besides the fact that these patients are to some extent under treated and not fully treated, There is also a surge of diagnosis ongoing across the globe, and that has to do with the aging population

Speaker 4

on the

Speaker 3

globe. So, the expectation is that we'll see a doubling in the number of patients diagnosed in the next 15 to 20 years. So in a sense, this is a real pandemic. Next, please. We have used, as Goner pointed out, our top instrument to discover and also develop new treatments for Parkinson's disease.

We call it our discovery Machine, the ISP, the integrative screening process. This is an advanced systems biology approach combined with modern mathematical methodology to find new molecules, design and synthesize and test new molecules, which have beneficial effects in certain brain states. And in our case, we are focusing very much on Parkinson, as I said. We have proven advantages with this system. We see that we can discover truly novel first in class compounds.

Both our clinical assets, mesdopetam and piripimat are first in class compounds. As a consequence of the discovery engine, we also get very strong IPR. We discover things that are not discoverable by other methodologies. And then, we also see if we go back in time, we see that we have an improved likelihood of phase transition or Probably the drug discovery success with this technology. Next, please.

So using the technology, we have based our pipeline products on needs for Parkinson patients. So if we look at the next slide or next click. First of all, we have the bradykinesia, the Tremor and the rigidity, which is undertreated to date. And here we have developed 11/17. Next, please.

11/17 is our target molecule for these symptoms. This is a molecule which can, as Gunnar pointed out, it has the potential actually to replace the Evodopa

Speaker 2

in the

Speaker 3

future. But above all, this is a treatment that we can the patients can take hopefully once daily and without the complications of levodopa. Next, please. Next again. To treat the dyskinesias which are associated With levodopa treatment for thought or long term, studies indicate that over a couple of years after initiation of levodopa treatment in patients, dyskinesias are starting to emerge and psychosis.

And this is a complicating factor in the treatment algorithm. It often means that patients go down in levodopa dosing to avoid the dyskinesias. And mesdopetam has been discovered and developed through Phase 2b to actually treat levodopa and even Possibly prevent the occurrence of levodopa induced dyskinesias. Next, please. Later on in the development of disorder, the neuropsychiatric symptoms become very apparent.

Next, please. Next. So we have 2 assets here, IL-seven fifty seven focusing on apathy And the neurobiology behind apathy, we're trying to correct aspects of cortical, subcortical that is signaling from upper layers of the brain to lower levels of the brain or deeper levels of the brain, I should say, to treat apathy. And then we have 942 in development, preclinical development right now For cognitive deficits or cognitive impairment in Parkinson's disease. And cognition is a huge problem.

Dementia is Parkinson's disease, it's like Alzheimer's, dementia's disease. There are very poor Treatment alternatives in this space, in this indication, I should say, for these patients. And therefore, we are looking at 942 as a better treatment for cognitive impairment. Both of these molecules Are focusing on neuropsychiatric symptoms, which of course have a broader scope than just Parkinson's disease. So here we're looking at additional neuropsychiatric and neurodegenerative disorders.

And last but not least, next, please. In the later stages of Parkinson's disease, balance and falls It comes a huge problem, next, as also indicated by the patients themselves. And there we have developed peripemat, which is now in a huge Phase 2b study across Europe. Next, please. Few words on mestopetam.

This is a dopamine D3 receptor antagonist discovered by ISP. It also has potential in the treatment of psychosis and Parkinson's or Parkinson's disease psychosis, but also as a prevention for levodopa induced dyskinesias. The program is licensed to Ipsen, our collaboration partner, which we're working towards further studies working together with them towards further studies and eventually a registration of the product. Next, please. So, during the course of development of Mestopperdam, we have taken it through a quite comprehensive Programme of Phase 1 and Phase 2 studies by now.

First of all, we have the Phase 1 study In healthy volunteers, we did a small Phase 1b study in Scandinavia where we actually collected the first signs of Efficacy using the Unified Dyskinesia Rating Scale, the U. S. RS and other scales. We had a nice effect and this is published. Then we have the Phase 2a study where we continue to expand the population looking at other instruments for measuring dyskinesia, but also other exploring the best methodology to collect information about antidyskinetic efficacy and the consequences in terms of function for the patients.

And more recently, as Gunnar alluded to, we have published data from our Phase 2b study, top line data From a large Phase IIb study, which we conducted in the U. S, Europe and Israel. And the findings there is that we have a Dose dependent pattern of efficacy across anti dyskinetic scales or the scales used in the study. We do see an improvement in OFF in the study as published. And then we also can Conclude that this is a safe and very highly tolerable compound, much more so than competitors that we know the data about.

And that is mainly the registered product, Amantadine. So, we have expanded the information across these studies about the effect of mestopetrol. We've also learned a lot About how to manage clinical trials in this space during the period and also how to administer the scales that are used. And the perhaps most gratifying thing with this study was that we came out with a very, very A highly significant effect on or nominally significant effect on the UBIS RS scale, which is the scale preferred by regulatory Bodies across the globe to assess on Phase II Skinesia, which is the thing we want to treat. So next steps is Presenting to you a plan for Phase 3 and also registration.

Next, please. Pir Demand, this is a molecule we have developed over a couple of years. This is a totally new approach to the treatment for a treatment in Parkinson's disease focusing on force and balance. We have an ongoing study across Europe And this is a wholly owned asset at this time. Next, please.

Why is it important to prevent falls in Parkinson disease? Well, as you hear from the patients, this is one of the biggest problems. And actually, about 50% of all Parkinson Patients fall on a yearly basis and much more than that actually. And patients who fall, they have A shorter lifetime expectancy as well. And the reasons for falling is, of course, a complex The thing we are the mechanisms that we are focusing on with Peripemat is those that are related to Cortical function, the upper layers of the brain and which are associated with the cognitive decline.

It has been published and known for a couple of decades actually that the cognitive decline leads to impaired balance or is correlated to impaired balance and focus, which is, of course, something that occurs in the later stages of Parkinson disease. Next, please. Piriformat has been designed then to activate Those neural pathways in the cortical areas of the brain, which are associated to falls and cognitive decline, We do so by it does so by inhibiting the activity at 5H7 and Alpha2 receptors. And the combined effect here leads to a quite significant activation of neural activity in frontal cortical areas. There is a huge number of patients out there needing treatment and this is, As I said, a totally new indication in terms of drug development.

So we are addressing a new untapped market as well with this program. The cost of injuries related to falls in the elderly and especially in Parkinson disease is Really high. CDC has estimated that the fall ending up in a hospital or leading to hospitalization Actually costs around $30,000 to treat. So there is much to be gained both from the individual perspective and from the societal and cost perspective with the new treatment. Next, please.

Also here, we have taken this through a quite comprehensive program. We have published much of the documentation around this molecule in Highly ranked scientific journals. Next, please. Phase 1 studies. We've done Phase 1 studies in healthy volunteers indicating that the drug is highly tolerable, safe in healthy volunteers.

We have defined a new formulation for the compound, which we are using in the current studies. We have explored the pharmacokinetics in Phase 1, Phase 1 with the tablet formulation. We have generated Phase 2a data indicating that the kinetics are the same in the intended treatment population. But also, we found Quite significant signals of improvement of balance, improvement less falls. We saw improvement in neuropsychiatric endpoints such as apathy and we also had a significant effect on cognitive functions with Pirapemat.

And all this points towards cortical activation of Pirapemat, which we are now exploring in a large Phase IIb study. Next, please. And this study is a study with the intention to explore the efficacy and safety of PPV marked In a much larger population, this is 165 patient study, which we are conducting in 5 or 6 countries, I can't remember now, across Europe. We are looking at falls and falls frequency. We are also looking at cognitive function.

The Core symptoms of Parkinson's, of course, we don't want to affect those and then the posture dysfunction, but also a global function assessment for these patients. Next, please. The study design is quite simple. We have a 1 placebo arm and we have 2 treatment arms, 1 at 300 milligrams and 1 at 600 milligrams. We have some specifics when it comes to inclusion criteria and that is that the patients should have fallen at least 2 times In the month preceding randomization into the study, we have also The run-in period in this study.

And there's a 3 months treatment period followed by a couple of weeks follow-up and tapering of the treatment. We are in the middle of this trial. It's from my perspective, it looks really nice in terms of recruitment. We have also Quite recently expanded into the Netherlands, employing or including a couple of expert sites in the Netherlands where some of the most prominent forms researchers in the world actually work. So and they have a quite large patient population there as well.

And we're looking forward to concluding the recruitment during the fall this year, that is our plan. And we expect to have data around this time next year. Next, please. A few words on the preclinical candidates, 757 focusing on apathy, 942 and 1117. Next, please.

So for 757, we have quite broad indication area. This is treatment for apathy. And apathy is a syndrome where you have loss of initiative, interest and emotional expressions. This is different from depression and it's really frustrating for the patient, but also for the caregivers. And There is no treatment for apathy today.

We think that we have discovered a new way to address this issue with this program. And we are right now in the final stages of the preclinical development, including CMC, And we expect to be Phase 1 ready during the fall or at the end of this year for this program. For 942, we are looking at the improvement of cognition and here we have the full preclinical package indicates A clear cognitive enhancement across different types of cognitive modalities. And We are right now also here in the middle of the IND enabling studies and the development of the CMC. And when I say development of CMC, I mean the production of the product or the compound According to GMP, but also a drug product that is a capsulorab tablet.

And then level 17, which Goner alluded to, which we think is a really important discovery that we've made in our laboratories. Here, we have a one stated treatment for the core symptoms of Parkinson's disease. This doesn't sound very compelling, perhaps once Daily, what does that matter? Well, it has a huge impact for the patients. Today, they are taking the delivered medication up to 6, 8 times a day, which leads to fluctuations, variations in efficacy.

Here we can possibly provide a treatment which Apathy as such is quite common in neurological disorders There is some publications out there indicating it varies between 20% to 80%, 90% for each indication, including Alzheimer's, vascular dementia, frontotemporal dementia, but also Parkinson's disease. And the reason for apathy or the hypothesis for the occurrence of apathy is a disruption of Connections between cortical areas and subcortical areas in the brain. We believe that 757 through the mechanism it actually have both potential for symptomatic treatment And disease modification, there is some support for disease modifying properties with molecules of this type. I'll come back to that later on. Next.

Looking at cognitive Impairment in neurological disorders, it's also very, very common, 25% to 30% of all Patients with PD have dementia and 12% of all people About 65 years have problems with cognitive impairment. So this is a huge indication area and there are, of course, treatment options out there today Such as choleinesterase inhibitors and an MDA antagonist such as memantine. But they Come with side effects and here we are looking at something that could have a better efficacy without the traditional side effects you get from these treatments. Next, please. Going back to 11.17, we touched upon that a couple of times during this quarter today.

But in principle, we have We've been able to solve a problem and this is, of course, from an R and D perspective, from the scientists' perspective, a quite fascinating program since we've solved the problem that has been hanging around in the field for the last 60 years since the introduction of levodopa. So, we have discovered Noble class of molecules which can have a full anti quarkinsonian effect in preclinical models without compromising motor function, without the fluctuations and the long lasting effect in the models that we have used up to actually beyond 10 hours of treatment effect in rodent points of particle services. Next, please. So, we'll Stop here with that little update and I'll hand over the microphone and camera to Victor.

Speaker 4

Thank you, Nikolas. So a glance at the figures, please, next slide. Well, we can see that we still have a quite high cash position of a bit more than SEK 200,000,000. If we look at the cost in the middle of the slide, we can see that we have quite much higher cost this Quarter than we've had previously. A lot of that has to do with the one time cost associated with the termination of the last CEO during February, which has affected this quarter as a one time cost and will not have any effects on the quarters going forward.

So that is not cash flow that doesn't have any cash flow effects. So the cash flow during the quarter was a bit more than SEK40 which is in line with the previous quarters. However, even though we subtract the one time costs for the CEO from this We have an increase in the costs and that is mostly has to do with the investments in the Phase 2b study in Biritma and also advancing the preclinical projects 757, 942 and 1117 towards clinical Phase 1. So that is what drives the cost. As you can see to the right in the slide, we have Maintain the number of employees.

We are about 30 people here, highly efficient And we think that this is quite good level at the moment. Having said that and that we have over SEK 200,000,000 In cash, and we have increased cost. We have an increased focus on cost control And the development of the preclinical assets, we do that with Cost control limitations, you could say. So we are doing everything we need to, but we still have a cost control. So next slide, please.

Well, just the or not just, but the analysts that cover us, Redeye, ABG and Edison, and they will have some questions after this presentation. And having said that, Gunnar, Some final

Speaker 2

words. Okay. So, full summary, let's start with our development portfolio. And as I said before, we view this as world leading portfolio in Parkinson's disease with regard to compounds in development. Restopetone, our lead compound partnered with Ipsen, we finalized the Phase 2b study And we are now starting planning for Phase 3.

Pirecimat, we have started the Phase 2b study to find the right dose and see we have a dose dependent efficacy in preventing falls. We anticipate the finalization of patient improvement during the year and top line results of First of next year, 942, our candidate drug Going for treatment of cognitive impairment and as Nicolas said, of course, we have a focus on polysilon, but this will also Have the possibility of going broader for other patients categories with cognitive impairment. 757, our candidate drug for apathy. And again, as Nicolas stated, Apathy is occurring in a number of neurological diseases and of course we anticipate the effects of being across These different situations, at lastly 11/17, Our molecule that aims to treat the cardinal symptoms of porphyxone, but without the limitations that we see from We will do for the present available treatment. Next slide, please.

Some anticipated key development milestones over the next 18 months Starting in Q2 this year, we are working with Ipsen on the mescopidone data And we hope to be able to present all the data during this year. But second half this year, We should see 757 to be Phase 1 ready. Piritimat, We aim to have the patient recruitment completed and for 942 we continue to prepare For Phase 1 study. And first half, next year, Curepim Health Phase 2b top line data announced to have 942 Phase 1 ready And to have 1117 continued preclinical development to aim for Phase 1 study preparation. When it comes to events, we will continue to have participation in Investor events as well as medical and scientific congresses over the next 18 months.

And then for the second half this year, we are planning to have a Capital Markets Day. Next slide. So again, IRID Lab at a glance, Pioneering biology and a unique ISP for identification of new candidate drugs. Focus, strategy to focus on and all its complications through the disease journey, Validated our way of working from CD selection to delivering positive clinical results And our first program out licensed the major pharma. A broad and solid and I would say world leading portfolio in Porkystone with unique molecules with high potential call coming out of our ISP platform And an organization positioned for success.

Thank you. And I think that this leads us into The last part that is the question and answer session.

Speaker 1

So much, Gunnar And Nicolas and Victor, very interesting presentation indeed. So it's time for the equity analysts to shoot their questions. And we will start off with Sue Romanov of Edison. Please go ahead with your questions, Sue.

Speaker 5

Thank you for the update and taking my questions. So, we understand that you're not Going to be able to disclose much on the Ipsen's path forward for mesopetem, but we're really encouraged by the Q1 report with Ipsen conducting preparatory Phase 3 pharmacokinetic studies and manufacturing of musapotan. Can we infer that the preparation is still ongoing as planned?

Speaker 2

All the activities are ongoing as planned. But as I stated, we have initiated discussions on The next way forward as a way to really give Birkbeck von Braun the best chances To get to registration and to get to patients in need. I cannot today disclose Any details of the discussions that we are holding at the moment, because they are still ongoing according to the contractual agreements, We are not able to unilaterally communicate anything on those details.

Speaker 5

Great. That's helpful. So for IRL757, It's going to be in Phase it's Phase 1 ready by the end of this fiscal year. Can we assume that this is a strategic priority with Gurlabs' preclinical pipeline?

Speaker 2

I definitely think so. And JAVINCIMO, I would say, Phase 1 ready, that is that in order to go into the Phase 1 study to get it up and running, there is a need to agree with Those types of discussions are ongoing at the moment that we can't disclose exact starting that for that reason. But definitely Our activities for preclinical development are on schedule and they are moving ahead with the Apep Phase 1 Revit product before the end of the year.

Speaker 5

And any other preclinical assets And updates on how they're progressing would be helpful too.

Speaker 2

Yes. Amit, When you do the development activities to get to an IND and the permission to do Clinical Phase 1 studies. This is very regulated Type of activities and of course we follow all the regulations we are doing, all the activities to be able to produce The material and to produce the study material that is captures or tablets for the studies. In parallel, we are doing all the toxicology programs that are needed to really make sure that it is good safety when you start to dose In human beings. So everything there is running according to the schedule.

Speaker 5

Great. Thank you for answering my questions.

Speaker 1

Thank you, Sue Romanoff. And let's move on to Gonzalo Artjak at ABG Sundal and Collier. Please go ahead.

Speaker 6

Hi, and thank you for taking my questions. The first one is that, I mean, it's on, again, following from before the Ipsen situation. Now you have communicated You are in ongoing discussions with them since the beginning of May to decide the best path forward for Mesopotam. And I could imagine that these discussions come as a result of having now the whole data set completely analyzed. So now you have a better picture of the efficacy data from the study.

Could you give us some color on this? And how clear are the reasons now Of the discrepancies between the different endpoints now that you have probably a better picture? Thank you.

Speaker 2

As Nicolas stated, And actually communicated in January, we do see a very clear anti dyskinetic effect. And what we also can say that is that we see very good dose response Pattern, this is important because if you have a dose response pattern when you test A drug for certain effects, then you know almost for sure that this works. If you only have one dose, you never know is there a chance finding or is it something all that's going on, but if you do have a dose response pattern, You are pretty sure there is an effect. This coupled with a couple of additional things. First, of course, the very good safety tolerability profile, because if you should be able to use the product, Of course, you need to have a good safety tolerability profile and that is really what limits Today's available therapy for dyskinesia is very, I would say, very severe side effect potential, Which limits the use and which also limits the dose level that you use in order to try to avoid side effects.

We don't foresee any of that problems with a stop at home. On top of this, A very important finding that we don't infer the leobodopa treatment effect when giving Our compound is extremely important. That just the fact that we also see A dose response pattern for off effect or off time effect, I should say. So, I think that the in-depth analysis, I could say that it has confirmed The antidiskinetic effect that we reported in January.

Speaker 6

Okay. Thank you very much. And the second question, of course, now if Ipsen decides to move forward as planned, then the clinical development will just continue as expected. But putting ourselves in a hypothetical case where Ipsen does not consider the risk benefit Good enough to support the Phase 3. And what are the plans that you will have for the molecule?

Would you consider to move forward alone, given the fact that you have already, as you And as you describe positive signs of antidiskinetic effects or financially would that be too complicated or would you just like deprioritize the molecule and focus on And Peter Beaumont?

Speaker 2

First of all, I want to really emphasize that what I'm now stating that is Completely hypothetically since we don't really know where the ongoing discussions will end. But we are So, it's mentally preparing ourselves for all the different scenarios and so what can we do to prepare us for different scenarios. Of course, one scenario is to continue with Ipsen as the initial contract states. Other scenarios would be that We, I mean, if I take the other extreme, that is that if we were to take this all, we are definitely committed to see that Yes, Tropitin should come to the benefit of patients. All our both commercial as well as regulatory advisers Have a very strong belief in the potential of vistopatone.

So If that would be the case that we would take this from Eelab's point of view, we would of course need to evaluate all kind of Other potential ways to get it forward, but the compound has such quality that definitely We believe that it should come to registration and to the benefit of patients.

Speaker 6

Yes, that's clear. Thank you very much. And one last question, if I can. As you probably have seen about a week ago, Pharmather applied for Fast Track designation to the FDA for the use of Ketamine in low dose for the treatment of PD leads. If I'm not wrong, they are planning now for a Phase 3.

So what they have seen in the YSRS is that they have a 41% reduction of dyskinesias from baseline to after 3 months. How good do you think this is? I mean, not just in efficacy, but also in terms of safety and how much does this compare with what you could see with Nezdopetam?

Speaker 2

I think for me, there is still the need to understand how they are going to use The ketamine product. And the reason I say this is that we're really here with a molecule that has an extremely short path life. So the big question for me is how do you dose it so that you cover the treatment period you want to cover. Secondly, It is a compound with very difficult pharmacokinetic and a lot of drug interaction Potentials. But what we know with Parkinson patients that are elderly, that is that they take a lot of medication How you will be able to in a safe way handle the product in this patient category It's still something that I think needs to be proven.

Speaker 6

Okay. Thank you very much.

Speaker 1

Artjak, let's move on to the 3rd equity analyst that is Frederik Thor at Redeye. Please go ahead.

Speaker 7

Yes, thank you. I was just wondering if you could develop a bit on cost developments for 'twenty three and 'twenty four, I mean, Given the activities you have planned, we can do it a little bit more throughout the year.

Speaker 2

I think that I'll take

Speaker 4

Sure. This is not something that we have guided upon, but you could see that what we have said is that the cost during the quarters, the past 3, 4 quarters has been around or a bit more than SEK 40,000,000 and we're also stating that the activities in the lab and in the clinics are increasing. So then you can draw your own conclusions basically. And that is also why we said that we have a strict cost control in the company at the moment, doing the things we need to do and doing everything we have to maintain the regulatory requirements and so on in all the projects. But we have keep a close eye on the costs at the moment.

Speaker 7

Perfect. And maybe a question for Nicholas about the 942 in the cognitive impairment. I mean, given the advancements within Alzheimer's, this is, could you maybe elaborate this, is there potential in Alzheimer's? And, yeah, is this Something you look at?

Speaker 3

Absolutely. As I alluded to, this is both 757 and 942, which is the Compound design for cognitive improvement or impairments is have a broader scope than just Parkinson's disease. And that's something we're actually looking into quite carefully right now, how to best Move those 2 assets forward given that they go beyond they have the potential beyond Parkinson disease.

Speaker 7

Yes, I think that's actually all the questions I had. So thank you. Thank you.

Speaker 1

Thank you, Fredrik. And that will be all the questions Thanks for today. So thank you so much to Gunnar, Nicolas and Victor for your presentation. And to you who have been watching, please see us again within 3 months. Thank you.

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