IRLAB Therapeutics AB

STO:IRLAB A

Earnings Call Transcript 2023-Q1

[Operator]

Welcome. Research company IRLAB have released its report for the first quarter in 2023. To present the results, I have on link CEO, Gunnar Olson; Executive Vice President, Nicholas Waters, also Head of Research and Development; and CFO, Viktor Siewertz. After the presentation, there will be held a Q&A session with equity analysts.With that, I'll hand it over to the company. Please go ahead with your presentation.

[Gunnar Olsson, executive]

Thank you. Good morning, and welcome to this webcast on quarter 1 results for IRLAB.If we take the next slide and the next agenda. So today's agenda, I, Gunnar Olsson, the CEO, I will present highlights during the quarter. And Nicholas Water, Head of R&D, will give you an update on the R&D. And then Viktor Siewertz, our CFO, will give a financial update. And I will come back and do some concluding words to lead in into the Q&A session.First, a summary of events during the first quarter. If I get the first slide. IRLAB participated in the Sixth Neuroscience Innovation Forum in San Francisco in the first 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, IRL1117, and this is a candidate drug that comes from the P003 research project. 1117 will be developed to be a once-daily oral treatment for the cardinal symptoms of Parkinson's disease, and that is the tremor, the rigidity and the bradykinesia. 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's mainstay therapy in Parkinson's. 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 IIb study with mesdopetam in patients with Parkinson's and 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 for further clinical studies in Phase III. Mesdopetam demonstrated in the study clear antidyskinetic effect throughout the 12-week treatment period, and on the safety and tolerability side, mesdopetam was on par with placebo.The antidyskinetic effect was achieved without reducing normal motor function, and this is, of course, very important. And the profile was further strengthened by a clear reduction in Off-time. Detailed analysis of the full data set is still ongoing in collaboration with our partner Ipsen, and we aim to present all the data during the year.Next. In mid-February, the company announced an update of the portfolio development milestones following an internal assessment of the operational priorities for the year. On February 20, me -- I was appointed as an Interim CEO following Richard Godfrey's termination. Carola Lemne, the former Vice Chair, took over the role as Chairperson of the Board from me. And An van Es-Johansson elected to leave her role as a Board Member on the 21st of February.As the new Chairperson of IRLAB, Carola Lemne took over the membership in the Nomination Committee from me since I resigned as the Chairperson of the Board.Next, please. At the end of March, IRLAB presented new data regarding our candidates [ IRL942, IRL757 ] and the ISP platform at the National Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders. At the same conference, the industry symposium was organized by IRLAB on the last of March. And the symposium had the title The Management Dilemma of Parkinson's Disease Progression and Emerging Treatment Approaches. The symposium was recorded and it is available through a link on the IRLAB website.Next, please. Beginning of May, IRLAB was made aware that Ispen's 2022 universal registration document published on April 8 contained incorrect information that the development and commercialization rights for mesdopetam have been transferred back to IRLAB. This is incorrect and Ispen corrected the universal registration document on May 4. Following a contact from Ispen on May 1, a discussion has been initiated with IRLAB to mutually agree the best way forward for the mesdopetam program to reach registration and to ensure that mesdopetam can be made available to patients with Parkinson's disease.Next, please. The financial highlights in brief. During the quarter, we had low recorded sales. We had a total operation expenses of SEK 59.5 million. Viktor will go more into detail the reasons why the uptake of the total operating expenses. We had an operating result of minus SEK 59.5 million. And cash flow from operations, SEK 41.5 million, and cash equivalents at the end of the period amounted to SEK 210 million. The total number of registered shares at the end of the period is just south of 52 million.Next, please. So IRLAB at a glance. We are working with pioneering biology and we have the unique USP platform and this is built on a very deep and profound understanding of Parkinson's disease emanating from the team around ArvidCarlsson, Nobel laurate, around Parkinson's. We have a focused strategy. We provide therapy to many Parkinson patients throughout the disease journey. We have validated the way we work. We have discovered new CDs. We taken them from CD to Phase II validation in patients. And our first program is outlicensedto a major pharma company.We have a board and solid portfolio, and I would actually take in my mouth and say that within the Parkinson's 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 Nasdaq Stockholm.And with that, I think it's time to move into the early update. So please, Nicholas.

[Nicholas Waters, executive]

Thank you, Gunnar, and thank you all for listening today. I'll go through a few aspects of our development programs as we stand here. IRLAB has a profound [Technical Difficulty] 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. IRLAB, 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 that is, it depends basically on the loss of dopamine neurons, which around 80% -- 50% to 80% of all cells containing dopamine are lost and then you get the symptoms.And the symptoms are very clear to a physician. You get tremor, bradykinesia, rigidity, aching, slowness movement and stiffness. And later on in the development of the disorder, you also get trouble with balance and focus. During the course of the disease, there are a number of options to treat this disorder available, but all are basically based on the basic treatment with levodopa, which is converted to dopamine in the brain and thus exerts the effect of the lost dopamine.This is a fantastic innovation on a 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 a 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 the biggest problems. And this is something that is really, really important to note 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's disease, that is bradykinesia, the slowness of movement and the tremor despite the fact that levodopa is available. And to me and to us, that tells what has also been published that patients in general are undertreated with levodopa. And that is -- that has to do with the risks that are associated with the treatment with levodopa. And 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. And 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 in Parkinson's.Next, please. Besides the fact that these patients are, to some extent, undertreated and not fully treated, there is also a surge of diagnosis ongoing across the globe, and that has to do with the aging population on the 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 Gunnar pointed out, our top instrument to discover and also develop new treatments for Parkinson 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, mestopetam and pirepemat, 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 can go back in time, we see that we have an improved likelihood of phase transition or probably drug discovery success with this technology.Next, please. So using the technology, we have based our pipeline products on needs for Parkinson's 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 today. And here, we have developed 1117.Next, please. 1117 is our target molecule for these symptoms. And this is a molecule which can -- as Gunnar pointed out, it has the potential actually to replace levodopa in the 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 short or long term, studies indicate that only 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 IIb to actually treat levodopa and even possibly prevent the occurrence of levodopa-induced dyskinesiasNext, please. Later on in the development of disorder, the neuropsychiatric symptoms become very apparent.Next, please. Next, next. So we have 2 assets here, IRL757, focusing on apathy and the neurobiology behind apathy. We're trying to correct aspects of corticostriatal, that is signaling from upper layers of the brain to lower levels of the brain -- or deeper levels of the brand, 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 a consequence of Parkinson's disease. It's like Alzheimer's, a dementia disease. There are very core 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 becomes a huge problem -- next -- as also indicated by the patients themselves. And there we have developed pirepemat, which is now in a huge Phase IIb study [indiscernible].Next, please. A few words on mesdopetam. This is a dopamine D3 receptor antagonist discovered by ISP. It also has potential in the treatment of psychosis and Parkinson's -- or Parkinson 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 -- we're working together with them towards further studies and eventually a registration of the product.Next, please. So during the course of development of mesdopetam, we have taken it through a quite comprehensive program of Phase I and Phase II studies by now. First of all, we have the Phase I study in healthy volunteers. We did a small Phase Ib study in Scandinavia, where we actually collected the first signs of efficacy using the Unified Dyskinesia Rating Scale, the UDysRS, and other scales. We had a nice effect, and this is published.Then we have the Phase IIa study, where we continued to expand the population, looking at other instruments for measuring dyskinesia, but also exploring the best methodology to collect information about antidyskinetic efficacy and the consequences of -- in terms of function for the patients.And more recently, as Gunnar alluded to, we have published data from our Phase IIb 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 antidyskinetic 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 the studies about the effect of mestopetan. 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 a nominal significant effect on the UDysRS scale, which is the scale preferred by regulatory bodies across the globe to assess ON-phase dyskinesia, which is the thing we want to treat.So next steps is presenting to you a plan for Phase III and also [Audio Gap]Next, please. Pirepemat, this is a molecule we have developed over a couple of years. This is a totally new approach to the treatment -- for the treatment in Parkinson's disease focusing on falls 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's disease? Well, as you hear from the patient, this is one of the biggest problems. And actually, about 50% of all Parkinson's 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 thing, but the thing we are -- the mechanism that we are focusing on with pirepemat is the dose 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 correlated to impaired balance and falls, which is, of course, something that occurs in the later stages of Parkinson's disease.Next, please. Pirepemat has been designed then to activate those normal 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 5HT7 and alpha-2 receptors. And the combined effect here leads to a quite significant activation of neuronal 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's disease is really high. CDC has estimated that the fall landing up in a hospital 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 it through a quite comprehensive program. We have published much of the documentation around this molecule in highly ranked scientific journals.Next, please. Phase I studies -- we've done -- Phase I studies have the 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 pharmakinetics in Phase I with a tablet formulation. We have generated Phase IIa 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 pirepemat. And all this points towards cortical activation of pirepemat, 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 pirepemat 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 free. So 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 one placebo arm and we have 2 treatment arms, one at 300 milligrams and one 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 a running period in this study. And there's a 3-month treatment period followed by a couple of weeks follow-up and tapering of the treatment. We are in the middle of this trial. 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 falls researchers in the world actually work. 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 117.Next, please. So for 757, we have a quite broad indication area. This is treatment for apathy. And apathy is a syndrome where you can 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 I 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 capsule or a tablet.And then 1117, which Gunnar alluded to, which we think is a really important discovery that we've made in our laboratories. Here, we have a once-daily treatment for the core symptoms of Parkinson's disease. This doesn't sound very, very compelling, perhaps once daily. What does that matter? Well, it has a huge impact for the patients. Today, they are taking the levodopa medication up to 6, 8 times a day, which leads to fluctuations, variations in efficacy. Here, we can provide -- possibly provide a treatment which has sustained efficacy over the 24-hour cycle.Next, please. Apathy, as such, is quite common in neurological disorders. And there is some publications out there indicating it varies between 20% to 80% -- 90% for each indication, including Alzheimer, vascular dementia from the temporal 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 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 above 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 cholinesterase inhibitors and NMDA antagonists such as amantadine. But they come with side effects and they -- 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 1117. We touched upon that a couple of times during this call today. But in principle, we have been able to solve a problem, and this is, of course, from an R&D perspective, from the scientist 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 a novel class of molecules which can have a full antiparkinsonian effect in preclinical models without compromising multifunction, 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 models of Parkinson's disease.Next, please. So we'll stop here with that little update, and I'll hand over the microphone and camera to Viktor.

[Viktor Siewertz, executive]

Thank you, Nicholas. 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 million. 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 onetime costs associated with the termination of the last CEO during February, which has affected this quarter as a onetime cost. That will not have any effect 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 SEK 40 million, which is in line with the previous quarters. However, even though we subtract the onetime costs for the CEO from this quarter's cost, we have an increase in the costs. And that mostly has to do with the investments in the Phase IIb study in pirepemat, and also advancing the preclinical projects 757, 942 and 1117 towards clinical Phase I. So that is what drives the cost.As you can see to the right in the slide, we have maintained the number of employees. We are about 30 people here, highly efficient, and we think that this is a quite good level at the moment. Having said that, that we had over SEK 200 million 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 the cost control.So next slide, please. We'll just see -- 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 words.

[Gunnar Olsson, executive]

Okay. So for 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. Mesdopetam, our compound partnered with Ipsen, we finalized the Phase IIb study and we are now starting planning for Phase III. Pirepemat, we have started the Phase IIb study to find the right dose and to see if we have a dose-dependent efficacy in preventing falls.We anticipate the finalization of patient recruitment through the year and top line results in first half next year. 942, our candidate drug going for treatment of cognitive impairment. And as Nicholas said, of course, we have a focus on Parkinson's, but this will also have the possibility of going broader for other patient categories with cognitive impairment.757, our candidate drug for apathy. And again, as Nicholas stated, apathy is occurring in a number of neurological diseases. And of course, we anticipate the effect to be across these different situations.And lastly, 1117, our molecule that aims to treat the cardinal symptoms of Parkinson's, but without the limitations that we see from levodopa, 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 mesdopetam data and we hope to be able to present all the data during this year. Second half this year, we should see 757 to be Phase 1 ready. Pirepemat, we aim to have the patient recruitment completed. And for 942, we continue to prepare for Phase I study. And first half next year, pirepemat Phase IIb top line data announced, to have 942 Phase I ready, and to have 1117 on continued preclinical development to aim for Phase I 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're planning to have a Capital Markets Day.Next slide. So again, IRLAB at a glance. Pioneering biology and a unique ISP for identification of new candidate drugs. A focused strategy to Parkinson's 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 to major pharma. A broad and solid, and I would say, world-leading portfolio in Parkinson with unique molecules with high potential all 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, and that is the question-and-answer session.

[Operator]

Thank you so much, Gunnar and Nicholas and Viktor, very interesting presentation indeed. So it's time for the equity analysts to shoot their questions, and we will start off with Soo Romanoff of Edison. Please go ahead with your question, Soo.

[Soo Romanoff, analyst]

So we understand that you're not going to be able to disclose much on the Ipsen's path forward for mesdopetam, but we're really encouraged by the first quarter report with Ipsen conducting preparatory Phase III pharmakinetic studies and manufacturing of mesdopetam. Can we infer that the preparation is still ongoing as planned?

[Gunnar Olsson, executive]

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 the compound 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. And according to the contractual agreements, we are not able to unilaterally communicate anything on those details.

[Soo Romanoff, analyst]

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

[Gunnar Olsson, executive]

I definitely think so. And the reason why we say Phase I ready, that is that in order to go into the Phase I study to get it up and running, there is a need to agree with CROs to do the activities. And those types of discussions are ongoing at the moment, but we can't disclose exact starting of that, for that reason. But definitely, our activities for preclinical development are on schedule and they are moving ahead with the aim to have a Phase I ready product before the end of the year.

[Soo Romanoff, analyst]

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

[Gunnar Olsson, executive]

Yes. I mean when you do the development activities to get to IND and the permission to do clinical Phase I studies, there are -- 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 capsules 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.

[Operator]

And let's move on to Gonzalo Artiach at ABG Sundal and Collier.

[Gonzalo Artiach Castañón, analyst]

The first one is that -- I mean, it's again following from before the Ipsen situation. Now you have communicated that you are in ongoing discussions with them since the beginning of May to decide the best path forward for mesdopetam. 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?

[Gunnar Olsson, executive]

As Nicholas stated and actually communicated in January, we do see a very clear antidiskinetic effect. And what we also can say that is that we see very good dose response pattern. And 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 that's going on. But if you do have a dose response pattern, you're 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 dyskinesias. 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 mesdopetam. On top of this, the very important find that we don't impair the levodopa treatment effect when giving our compound is extremely important. That plus 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 antidyskinetic effect that we reported in January.

[Gonzalo Artiach Castañón, analyst]

Okay. And the second question. Of course, now if Ispen decides to move forward as planned, then the clinical development will just continue as expected. But putting ourselves in a hypothetical case where Ispen does not consider the risk-benefit good enough to support the Phase III, 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 nicely described, positive signs of antidyskinetic effects? Or financially would that be too complicated? Or would you just like to deprioritize the molecule and focus on pirepemat?

[Gunnar Olsson, executive]

First of all, I want to really emphasize that what I'm now stating that is completely hypothetical since we don't really know where the ongoing discussions will land. But we are mentally preferring ourselves for all the different scenarios and see where -- what can we do to prepare us for different scenarios. Of course, one scenario is to continue with Ipsen as the initial contract stage. Other scenarios would be that we -- I mean, if I take the other extreme, that is that if we were to face this one, we are definitely committed to seeing that mesdopetam 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 mesdopetam. So if that would be the case that we would take this from IRLAB's point of view, we would, of course, need to evaluate all kinds of other potential ways to get it forward.But the compound has such quality that definitely we believe that this should come to registration and to the benefit of patients.

[Gonzalo Artiach Castañón, analyst]

Yes. No, that's clear. And the one last question, if I can. As you probably have seen about a week ago, PharmaTher applied for faster designation to the FDA for the use of ketamine in low dose for the treatment of PD-LIDs. If I'm not wrong, they are planning now for a Phase III. So what they have seen in UDysRS 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 mesdopetam?

[Gunnar Olsson, executive]

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 dealing 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 [ prokinetic ] and a lot of drug interaction potentials. But what we know with Parkinson's patients that are elderly, that is that they take a lot of medication. And how you will be able to in a safe way handle the product in this patient category is still something that I think needs to be proven.

[Operator]

And let's move on to the third equity analyst that is Fredrik Thor at Redeye.

[Fredrik Thor, analyst]

Yes. I was just wondering if you could develop a bit on cost developments for '23 and '24. I mean, given the activities you have planned, if you can detail a little bit more throughout the year on the...

[Gunnar Olsson, executive]

I think that I'll take some help from Viktor here. So I'll ask Viktor could you please...

[Viktor Siewertz, executive]

Sure. This is not something that we had 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 million. 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.

[Fredrik Thor, analyst]

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

[Nicholas Waters, executive]

Absolutely. As I alluded to, this is both 757 and 942, which is the compound designed 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's disease.

[Operator]

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