IHLAB Therapeutics, a company discovering and developing treatments for Parkinson's disease, have republished their year end report for 2022. Today, we will be given a presentation by the company, followed by a Q and A session with Equity Analysts. So please welcome newly appointed CEO, Gunnar Olsson and Executive Vice President, Head of Research and Development, Mr. Nicholas Waters. Hello and welcome.
How do you do, Gunnar?
Hello and thank you, Matthias. We're fine here. We're ready to go.
Okay. So please, with no further ado, I hand it over to you to do your presentation.
Thank you very much. If I have the first slide, please. Good morning and very welcome to the Q4 year end summary from IRLab. Today's agenda is that I will start giving some opening words and news in the period. This would be followed by Niklas Votter to And then I will come back to give a summary of the portfolio, news flow events and an outlook.
Then we will end today with a Q and A session. So if I can have the next, please. Some opening words. Over the last couple of days, we have reported organizational changes, both at managerial as well as the board level. One of the key tasks for a company board that is to make sure that there is effective operational leadership On the company, last summer, we recruited Richard Godfrey to be our new CEO.
Over time, we have perceived that there was not the perfect match as we had anticipated due to different views in leadership style. As this became apparent to the board, The board took the responsibility to act swiftly and this resulted in the decision to change CEO. The board decided that I should step down as Chairman of the Board to be an ordinary Board member and at the same time take on the CEO role. And Carl Lemn, our previous Vice Chairman of the Board, to step up and to be the present Chairman of the Board. All these decisions were unanimously taken by the board members.
The day after these decisions were made, Ann Vanis Joanson informed the board that she had taken the decision to step down from the Board. With regard to the Board, The company article states that there should be 3 to 9 board members. At present, we are 4 board members. And that means that the board, as we foresee, will stay the same up until the AGM that will Take place in June later this year. So the way forward now, that is that I'm working very closely with the management team to make sure that we focus on strategic priorities for the companies.
And for this year, we should fully describe the potential of mestopetone as an effective and safe treatment in Parkinson's. We should drive to publish And present the comprehensive analysis and results of the Phase 2b trial one best of the time in scientific meetings as well as in scientific journals during the year. We should pursue The timely completion of the Phase 2b study of perepmed in Parkinson patients with frequent falls And we should progress our preclinical projects to see that they are moving towards entering clinical testing. Next, please. So operational highlights during the Q4.
We've seen the solid progress in the clinical, the preclinical and Research projects according to our plans. The Phase 2b study of mestopuran in patients with Parkinson's with leurodopamine used dyskinesias, we saw the completion of the patient recruitment. We have the database locked by end of last year and we report the top line results in mid January this year. We have new preclinical data that was published providing more insight into Mestopetan's mode of action will go to antipsychotic and antidiskinetic effects. These studies were performed in collaboration with academic scientists in Lund and Umea and the data was presented at the Premier Congress Neuroscience in the end of last year.
We've had presentations at both national and international Investor events, and you see the list on the slide. Next slide, please. Highlights, operational highlights after the end of the period. The 1st week of January, we participated in the 6th Neuroscience Innovation Forum. And this is a meeting that goes in parallel to the JPMorgan Healthcare Conference in San Francisco, United States.
Early in the year, we also nominated a new drug candidate, the 1117. And this is a compound that will be developed to be a once daily oral treatment for the And we should have these beneficial effects without the troublesome complications that we see in long term therapy with today's We have had The top line results from the Phase 2b study of Mesdopetan reported. But before I comment upon the results, I think that I want to give you a little bit of understanding of what different phases of clinical development Stands for and what the purpose is. So next slide, please. When we take the new molecule into clinical testing In phase 1, then we have a strong focus to understand the pharmacokinetics, and that is really to understand the exposure, so The blood concentration of the drug in human beings.
And we need to do this because we need to know that we don't expose The human being for higher concentrations of the drug than what we have tested in our toxicology programs preclinically. Of course, we are also looking for safety and tolerability. We then move on to Phase 2a and the purpose with Phase 2a That is to do exploration of efficacy signals. Do we see things that indicate that the molecule does what we expect it to do? We're also collecting safety and tolerability data, of course.
When we have detected the efficacy signal, we move into Phase 2b and here we want to establish a dose response relationship And then with the dose response relationship on efficacy, we also look into the safety tolerability profile And getting the safety and efficacy information that brings us to select the dose to be used For further testing. So it's really the dose that gives the best benefit risk ratio. When we have decided upon the dose, that's when we take that dose into Phase 3 testing. And here We are doing clinical trials to document the effect, document the effect on a very clearly stated primary endpoint And we need here to see significant P values because these Phase 3 studies, these are the key ones that the regulatory authority based The decision on approval for marketing of a new medicine. So with this background, Let's focus on the Phase 2b and go back to the mestopetan trial.
Next slide. So the 3rd bullet here. In the study that we ran, A dose dependent anti dyskinetic effect in several dyskinetic assessment scales And this was a safety tolerability profile on par with placebo. And we saw this even though we did not see a statistically significant effect on the defined primary endpoint, which was good on time. We, of course, will continue to do further and deeper analysis of the study.
But all in all, what does this mean in terms of my interpretation of the data? Well, I believe that mestopetan has a potential to become an effective and safe drug in Treating patients with Parkinson's disease. We have had the opportunity to speak to several External experts, clinical scientists, advisers on regulatory matters And we hear the same interpretation from those. This brings me to be optimistic. Of course, In a situation like this, you also ask yourself, have I seen something similar in the past?
Is there precedence of Joint development programs where there has been missed statistical significance of the Defined primary endpoint in Phase 2b, but still the molecule moved to become an effective drug. Yes, there are a number of such cases in the past. But I think that the most recent example is probably something that we have all seen lately. And that is actually the lecanumab molecule from BioOrctic. If you remember the Phase 2b study that they were running with that molecule did not come out statistically significant with regard to primary endpoint in Phase 2b.
After that, we saw The very beneficial effect seen in Phase 3. And now we know the rest of that story. So all in all, I do believe that we have a good chance with best of the time. Going back to the slide, the last bullet in mid February, we announced the update of the portfolio development milestone based on the assessment we did on the operational priorities for this year. Next slide, please.
Moving over to financial highlights for Q4. We have net sales of about SEK 12,000,000,000 and this is of course the results from services that we provided to Ipsen related to the development of Merstauptan. We had total operating expenses of Roughly NOK 46,000,000 an increase from last year. And this is based on the increased R and D activities that we have this year compared to last year. The operating result Coming down to minus SEK 33,000,000 cash flow during the period, minus SEK 38,000,000 And cash at the end of the year about 252,000,000.
The total number of shares Now being almost €52,000,000 Next slide. So Igla, at a quick glance, we are pioneering in biology and With the ISP platform build on a very deep and profound understanding of the biology capital to Parkinson's disease. We have a focused strategy. We are to provide medicines for treating patients throughout the disease journey We do that with our own molecules with blockbuster potential. We have Validated our model, one of our clinical programs are already licensed to pharma.
We have a broad and solid portfolio, 5 unique drug candidates, all with blockbuster Potentially, and they are all generated through our ISP platform. And we have an organization positioned to succeed. Experienced international organization, strong balance sheet and we are listed on the NASDAQ Stockholm. So with this, I think it's Time to move over to a more in-depth review of the R and D side as well as
Thank you, Unar, and hi, everybody. The R and D section of the presentation begins with a little short slide describing the Aspects of Parkinson's disease, which we are addressing. And as you know, PD is our main focus these days. And Parkinson's disease is dependent on a quite profound loss of dopamine innovation in imported brain areas. And dopamine has the role in the brain to control motor functions, cognitive functions, but also emotions.
And that's why patients who lose the dopamine system or lots of dopaminergic innovation, They show up with a lot of symptoms. And the cardinal symptoms of Parkinson's disease are is the tremor, which is Usually the first symptom, the bradykinesa, that is slowness of movement and then the stiffness, the rigidity. And all these aspects of Parkinson's disease are quite well treated with levodopa in the initial phases of after diagnosis. Later on in the disorder, in the disease journey comes the postural instability, which leads to falls, poor balance and falls. And these falls are of course a big problem for patients and patients' families, caregivers, but also for society in terms of taking care of the patients.
There are also other symptoms in PD, which are not so often discussed, such as the non motor symptoms. Psychosis is one of those, generally appears as hallucinations. There is neuropsychiatric symptoms as well, Apathy, dementia. PD like Alzheimer's disease is a dementia disorder. So Cognitive decline or cognitive impairment is quite common in Parkinson's disease, together with the motor symptoms.
And then of course in the late stages problems with speech and also with swallowing. These are all things which are guided by functions in the brain and in different brain areas and we are addressing this with our pipeline. Next slide, please. Looking at the number of patients out there, we've There are various numbers presented in publications, but epidemiological studies predict that we will have at least a doubling of the number of diagnosed patients across the globe by 15 to 20 years from now. So this is a true pandemic in a sense.
Also there are a number of aspects which are poorly treated in Parkinson's disease, disease. Above all, the poor posture stability balance and falls. The cognitive decline is Poorly managed today with today's alternatives. And of course, the motor complications, which we are addressing with Mesto Potam. And I'll come back to the core symptoms of Parkinson's disease later on in the presentation.
Next, please. As Gunnar mentioned, we have during the past 30 years as a research group, but also in various companies, developed a very refined strategy to discover new molecules, which we call ISP, The integrative screening process. This is a quite advanced systems biology based approach. And this is a kind of technology which is growing. There is an increased interest in these types of strategies.
We've seen a number of Companies and academic groups employing this type of strategy. However, we have Worked with this strategy since the mid-90s actually and we have generated by now we believe one of the perhaps the largest in vivo database on all CNS classes in the world. And this helps us to design new molecules, Investigate by means of machine learning techniques and other types of statistical models, what types of molecules to synthesize, what they will be good for and also we have the ability to also early in our screening strategy detect molecules which are not suitable for development. So we have a very efficient filtering out of effective molecules. There are a couple of effects of this strategy and one is that we Usually discover new types of treatment strategies.
So they are with a common name called 1st in class compounds. We also get very strong IPR, Composition of matter, as it's called in the U. S, it's are very strong. We have never have had any problems in getting our IPR through to date. And then we also see looking at our statistics that we have an improved probability of Phase transition with these molecules developed in this fashion.
All these things taken together makes this System very, very efficient in discovery. Next please. So next again, Looking at the patient journey in Parkinson's disease, it initiates with tremor, radiology and bradykinesia as we've discussed. And here we just launched a new program or a new candidate from a program we have been showing a little bit about during the And now we have nominated 1117 as the candidate drug in in this group of molecules. And this will be followed by a number of backups and follow ups, I can tell you.
This is a totally new strategy to treat the basic terms and symptoms of Parkinson's disease. And the objective here is to develop a once daily treatment, which addresses the fluctuations in response patients have on levodopa. Next please. Later on in the development of disorder comes the motor symptoms and dyskinesia is The neuropsychiatric symptoms, which are common in the mid stage to late stage Parkinson disease, apathy, Neuropsychiatric symptoms like depression are also there. Next, please.
We are addressing with Cognitive impairment, as I said before, PD is also a dementia disorder. And therefore, we think it's appropriate to actually try to support patients with something that can improve their cognitive function more than today's standard cholinesterase inhibitors. Next, please. IRN-nine forty two is our candidate drug in this development path. And at the top, next please, We have the balance and falls, which occurs in the late stage of Parkinson's disease, about half of all patients suffer from balance problems and falls.
Next, please. And then we have Pirapimat in an ongoing Phase 2b study across Europe. So next slide please. A few words about Mesdopetam, it's the dopamine D3 receptor antagonist. We've talked a lot About the D3 receptor and its involvement in the genesis of dyskinesia in the past few years.
This is a key receptor in driving what we believe is the core symptoms of dyskinesia in Parkinson's disease. We also see that this molecule has the potential as a prevention of actually getting this community in the first place. We licensed this the right to develop and market this molecule to Ipsen a year and a half ago. And since then we've had a very good collaboration with Ipsen on the program. Next please.
The full program is shown on this slide. As Gunnar alluded to, we've taken this now through A number of trials. First of all, the Phase 1 studies in healthy volunteers, where we could see that we have a safe And tolerable drug in healthy people. We also learned a lot about the pharmacokinetics. In between the Phase 2 and Phase 1, we also did a small Phase 1b study in Parkinson patients that was to smoothen the transition from healthy volunteers to patient populations in a smaller controlled group of patients.
And we did that in Scandinavia, where we could also confirm the kinetics of the molecule from a kinetic properties, but also some efficacy endpoints. Phase 2a study, a larger international study mainly conducted in the UK. We also there received a lot of information PK and efficacy. And more recently, the Phase 2b study, which we announced the top line results this winter in January. Next, please.
The path development path is outlined in a slightly different way in this slide, but it's basically the same kind of approach. Carefully managing increased numbers of patients through Phase 1 to Phase 2b, confirming that we have a safe and tolerable molecule in all studies from Phase 1b Through Phase 2a to Phase 2b, we have now honed in on the right dose for further development of the compound. Starting with the wider dose range in Phase 1b, narrowing that down in Phase 2a and even a narrower dose range in Phase 2b, which we agreed to study 3 different doses together with regulators of MRTPUTAM in the Phase 2b study that was. And as Gunnar informed, we do see clear dose dependent patterns of a number of very important aspects of treatment in this study. Next phase would be up to Ipsen to decide on the plans for the Phase 3 program.
Next, the Pirip Mart study, which is ongoing and Pirip Mart is a molecule which acts in a totally new way in terms of if one relates that to previously used molecules in the space. And this is designed to improve balance and reduce falls in Parkinson's. This is a program which we which is fully owned by Hoegh Lab. Next. So why is it so important to prevent falls or To reduce the risk of falling in Parkinson's disease.
Well, it is a big problem. It's very costly for the patient in terms of health risks, but also for society. It is coupled to the cognitive decline. The cognitive decline is related very strongly to impaired balance. The same neural pathways in the frontal cortical areas of the brain are involved.
This leads to falls when you have an impaired function in the frontal cortex and of course injuries. Next, As indicated before, about half of all patients at a given time have these balance problems and are at risk of falling. Patients can fall between a couple of times a week, a couple of times a month, but also several times a day. And that is a big, big negative on their life for these patients and the quality of life. And we have made some calculations on the number of patients, which are depicted in this slide.
We also looked at the health economic aspects of falling. And in general terms, one could say that A fall that ends up in a hospital, which is not uncommon, costs about $30,000 in the US. That's data from CDC. Next, please. So this is a molecule that combines Action at a number of receptors in the brain, receptors relating to the serotonin system, but mainly at the neuroendocrine in the frontal cortical areas.
So, 587 and alpha-two receptor antagonist is the key elements in the pharmacology of pyridmat. This is well tolerated in clinical studies. We have defined dose ranges in the previous trials and we're now looking at a dose The potential is quite large As indicated, a huge number of patients with this issue and quite substantial costs for society. The validation of the program has been done by WHO proposing a totally new INN stem name for this class of molecules. And we have published the preclinical and clinical data in highly ranked scientific journals to date.
Next please. Here also we've had a comprehensive development program starting with Phase 1 single ascending and multiple ascending doses, where we outlined the PK safety tolerability for the molecule. And that was followed by a larger Phase 2a study, where we explored efficacy, but also collected more safety and tolerability data for the molecule. And we are now in the middle of a larger Phase 2b study, which we are running right now in 5 countries in Europe, France, Germany, Poland, Spain and Sweden and we have recently received approval from the Dutch or the Netherlands regulatory authorities to run to include patients in the Netherlands. Next please.
Few words about the study as such. The primary objective or primary goal of this study is to assess the effect on falls and falls frequency in this patient population. But also we are collecting data which is related To cognitive function, if you recall, there is a strong relationship between cognitive decline and falls. So there should be some correlations there. We also are looking at the core symptoms of Parkinson's disease of course using the MDS UPDRS scale, the standard scale for assessing Parkinson's symptoms.
And of course, CGI's etcetera are included. Next please. And this is a study where we are studying placebo and 2 doses of Piripemod, 300 milligrams a day and 600 milligrams a day. This is a 3 month trial or a 12 week treatment period with a follow-up period and then assessment of the efficacy at 3 different times during the study. We are collecting the false data by means of diaries in this study as well.
Next please. A few words on the preclinical programs. 757, if you go to the next slide please. 757 is a totally new strategy to treat apathy. And apathy is a symptom which is poorly treated today.
There are actually no licensed products To treat apathy. There are a number of products that are treating depression. Apathy and depression are to some extent similar, but not the same thing. Apathy is loss of initiative, interest and emotional expressions. And this is a big, big issue in PD.
It hampers the life, the quality of life of patients with Parkinson's disease and also their families. We have discovered 757 through an effort to find molecules which can strengthen corticostratal connectivity, which is one of the hypothesis underlying the reasons for getting apathy. So we expect to finalize the preclinical development package this year and enter into Phase 1 during the end of the year. 942 is a molecule designed to restore cognitive function. And here we've done a number of preclinical experiments addressing cognitive function different modalities of cognitive function.
And we can see that we have a broad efficacy profile with 942 in these assays, giving us the argument to move this forward in preclinical development. And that's where we are right now. Hope to see this molecule moving into Phase 1 during H124. And last, but by no means least, 1117, our new candidate, Once daily treatment for Parkinson's disease. Next, please.
A few words on this program and I want to give you some context around this discovery program. The treatment med levodopa is in principle extremely effective, but it has its limitation. And one of the limitations that has been identified during the now almost 60 years of treating Parkinson's patients with levodopa, is the fluctuations, the fluctuations in response to treatment. As depicted in the red lines here in the graph. A challenge for the Scientific community, for the clinical development community and for the biotech and pharmaceutical industry during these 60 years has been to prolong the effect of levodopa and reduce the Truffs and peaks of efficacy that you see after levodopa treatment.
We believe that we now have discovered a technology where we can actually manage Treatment with once daily dosing, avoiding the peaks and the troughs with a long acting D1, D2 receptor agonist. This is something that has not been achieved before and there has been a lot of efforts trying to do that. So this is the first time we believe that there is a strong argument for a long acting oral D1D2 agonist. We are moving now forward in preclinical development with this molecule and we hope to be able to bring this also to Phase 1 studies in 2024. Next.
A few words on the financials. Can I give the next slide? If I start from the right hand side in this graph, during the past Few years we have grown in terms of number of employees in the company that has to do with the also the growth of our pipeline. If Those who have been with us for a while, you know that we started with Mesto Potam and Peartemath back in 2017. And Since then, we've expanded our pipeline.
We are now around 30 plus people working and we've stabilized that in the directly in the organization. If you look at the first graph there, it indicates The cash balance that we've had during the quarter since 2017 and you can see that we have been able to build up the Base level in the company, the financial base level in the company over these years. And now we have around 250,000,000 kroner at our disposal. That's $25,000,000 or €25,000,000 for those who want to know that. We've also seen that we have a quite stable expense level now at around SEK 40,000,000 per quarter.
Most of that goes to clinical development and the preclinical, including CMC work that we do for the programs. Next please. We have also coverage from Red Eye, ABG and Edison and we will hear from those in a few minutes. Next, please. I'll turn over to Gunnar again to finalize the presentation.
Thank you, Nikolas. So here we have a summary slide of the portfolio, A portfolio of compounds that could transform patients with Parkinson's. We've talked a lot about bestopetal. We have now finalized the Phase 2b study. We've seen the top line results and we are Evaluating the full study and we hope during the year to get more information out regarding the totality of results coming out of the trial.
As we've stated, the Continuation of development of the molecule will be the responsibility of Ipsen following the out licensing of the compound. With Pirapimat, we're now running the Phase 2b study in patients with Parkinson's and frequent falls. We hope to Complete the recruitment of patients before year end or at year end, so that we can have top line results first half next year. The preclinical assets, the 942 for treating Impact cognitive function, the 757 to treat apathy in several different neurological disorders, Of course, Parkinson included. And then 11.17, a new Basic treatment in Parkinson, something that we hope will really reach the state as standard treatment for Parkinson in the future.
That is at least where we're aiming for. Next slide. Over the next 18 months, we've identified the news flow and the events that will take place. I won't go into all the different items on this slide, but since you will be able to have the slides after the presentation, You will have the opportunity to look into the details. Next slide.
So again, IRLA at a glance, what is IRLA about? We've talked about the pioneering biology and the unique ISP. We've talked about the focused strategy on Parkinson and all the disease journey stages that we are aiming to treat. We've talked about the validation of our concept exemplified by the Licensing of messed up its time to Ipsen. We've talked about the broad and solid portfolio And we talked about the organization position to success.
So with this, I think that we are at the end of the presentation and I'll invite Niklas to come up to sit side by side to me And we're entering into the Q and A session.
Thank you so much, Gunnar and Nicolas. And I will actually immediately hand over to Fredrik Thore, analyst at Red Eye. Go ahead, Fredrik.
Yes, thank you. Thank you for a good presentation. So my first question was a bit about the sense of leadership or CEO. And you mentioned a bit that it has something to at least with leadership style. But does it have something to do With the mestopotom outcome, for example, is there a need for a change of direction or is it more like on a personal level?
No, it is no captain to the messed up the trial readout, absolutely not. This is more, as I mentioned, we've detected that we had different views on leadership style. And then we found It's the best for the company to make the change. And when we became aware of the situation, We wanted to handle this in a swift way and take the responsibility that a board has in the company.
Okay. And my next question was a bit about the Mestopaton trial, because the primary endpoint, you had Quite good statistical power. So I was wondering, given that you missed that outcome, can I give some more context to why you Do you think that there is a really good efficacy signal? Can you give some initial insights?
We start with Nicolas, and then maybe I, Phil.
Yeah. Of course, at this time, we cannot go into details about The outcomes, we are in the middle of analyzing all the data, but we are quite confident that We understand why the data looks like it looks. Without having shown it, it's hard to discuss it. But in principle, The power is not the problem here at all. It was perfectly powered.
And if you see The efficacy that we see on the other scales that we published in the press release, in the top line press release, where we have Quite substantial effects on based on the UDSRS scale. We also have effects on the UPDRS, which Looking at the data in totality and going back to the registration of GOCOVRI, which you're aware of, the amantadine formulation, we can Actually say already now that we would have fulfilled the same kind of criteria with this study.
Okay. And I guess, fill in and say, you're right, we missed the primary endpoint with regard to statistical improvement. This is what you sometimes face in clinical studies that you don't get the results you And this is why I want to emphasize once more that the most strong evidence that you have Efficiency of a compound that is that you can show a clear dose response pattern, so that you have an effect At the certain dose, you increase the doses, you see more of the effect and then you increase further and you see even more effect. And with the Result that we saw on anti dyskinetic scales, not just one, but several, that's why you hear me to say that I think that we have a very good case here and this is why I'm optimistic that mestopetan will become an effective and safe treatment in Parkinson's disease.
Okay, thank you. That's good context. Maybe a final short question. I think you have mentioned before that this So Phase IIb trial could be seen as a Phase III trial. Given the outcome, should we expect There will be 2 pivotal trials or only 1 or is it
But from a principal point of view, I think you're absolutely right that we have the Primary endpoint definition to be able to count this as one pivotal trial. We did not get that P value and that's why we today regard it more as a traditional Phase 2b study where we identify the right dose and We demonstrated the dose response pattern of the molecule.
And we also generated data sufficient for planning and for the next Stage of development?
Absolutely. I think that, as I stated when I talked about, in general, what you want to have From your different phases in drug development, we got what we wanted. We wanted to see a dose response for the efficacy of the drug. We wanted to see the tolerability based on the dose response on efficiencies and the tolerability safety profile. We were able to say this is the dose to use when we go into Phase 3.
And one aspect which rounds into discussions around the primary endpoint in a trial, in any trial actually, is usually the safety and tolerability. And here we have a drug which at efficacious doses does not differ from placebo in terms of adverse event profile. And that's quite unique in at least in Parkinson's, Totally unique. So we believe we have a very good cost benefit here for the patients or a efficacy benefit for the patients.
Okay. Thank you. And thank you, Fredrik. We need to move on to Gonzalo Artyak, ABG Sundal Collier. Please go ahead, Gonzalo.
Hi Gunnar and hi Nicolas. I have a couple of questions. And the first one is on the off time, the results that you reported in your top line data. I'm just thinking, I mean, you report a positive trend in this parameter where mesdopetum numerically reduced it in a dose dependent manner. But This is something that you did not see in your Phase 2a, right?
I mean, of course, it could be due to the duration of the trial. But could you give us Some color on that, why do you see this trend now and not before?
Yeah. Very good question. However, in the Phase Ib and Phase IIa studies, we looked at higher dose ranges. We had aggregated endpoints of overdose ranges, etcetera. And here we have tidied that up with fixed dose groups to actually be able to kind of unravel this additional effect of the compound.
And this is a really valuable addition to the understanding of the pharmacology of mestopetam, that we have this dose dependent effect on or dose dependent like effect onoff. This is one thing that the patients are extremely well equipped to sense and report. So this is a really good anchor point for further considerations of in protocols. And this was something that occurred during the trial during the course of the trial. And we will of course present time course data as we go along during the spring here.
Okay. Thank you very much. And a second question, I mean it's more like a, let's say, broad question. I mean as you say you're performing an in-depth Now of this Phase 2b data together with Ipsen. And I'm trying to understand, I mean, is there anything you can mention on what are the key points And that Ipsen needs or expects to see in order to decide how to proceed.
I mean, will it be linked on the magnitude of the trends that you see or it's Achieving a certain number of secondary endpoints or what can you say on that?
That's totally up to Ipsen to discuss those questions. We have a very strong and good collaboration with Ipsen. We are evaluating the data at present together. And there's still lots to go through, I can tell you. But when it comes to decision making, we will have to leave that to Ipsen to respond to that.
Okay. And if I can squeeze a fast one. In your discussions with Ipsen, are you still excited about starting a program in psychosis? Or it's something that will postpone until all this is solved?
Same answer there. It's up to Ipsen. But as Gunnar mentioned and what we've Published during the years that we have solidified our understanding from the preclinical perspective around the psychosis, the mechanisms, the brain mechanisms involved and the effect of mestobudan. So we have strengthened our At Eelab, our belief in the psychosis indication as an extension for this molecule. Yes.
All right.
Thank you very much.
Thank you, Gonzalo. Let's move over to Sue Romanoff at Edison. Please go ahead, Sue.
Hello. Thank you for taking my questions. Most of them are being covered here, but how about if we ask a few here Little in little different areas. I'm interested in hearing more about the modifying effects of IRL 942 and 757. It's nice to hear about them a little bit today.
But could we I believe we've mentioned that they play a role in disease modification.
Yeah, that's a possibility. I mean we don't have strong preclinical or data to support that statement. But looking at the What we use as an argument here from the preclinical perspective is the activation of certain gene pathways. Gene pathways which are involved in the survival of neurons in brains, in human brains and in animal brains. So that's one of the key things there.
Also the activation of monomeric functions in the cortex is one such aspect, which we believe may have an effect on the progression of these symptoms.
Okay. That's great. One is a little bit of housekeeping. I mean, we expect a lot of Clinical news maybe in 2023. Can you better help me better understand the anticipated cadence of R and D?
Can you clarify that question, Sue?
Yes. I just wanted to better understand how the R and D expenses that we kind of anticipate for this coming year.
Okay. If you look at the Financial charts in the we expect to spend around SEK40 1,000,000 a quarter during this year. And that's the same as previous years. We have not given prognosis Long term prognosis of our expenditures before. And so you will have to look at the previous quarters So then kind of make your own regression there.
But in principle, that's the base cost that we have. And you may also understand or know that now that the mestopotom trial is finalized, we won't have any Costs for that Phase 2b. The only large trial costs we will have this year is for Pirapimat.
Okay. Maybe I could squeeze one more in. How many patients have we recruited so far for Purimont Falls, the fall study?
We have not Publish that and we will probably give some updates during Q3 ish this year. But we have stated that we have activated now I think 28 out of the 39 sites. And this is also an important process as for those who are involved in clinical development to get all the sites up and running. It's a quite tedious job. It takes time.
And that is actually going ahead quite rapidly now and moving fast upwards. So we expect to have all the sites now in Q2, Q3 sorry, Q2.
Great. Thank you so much for taking my questions.
Thank you so much, sir Romanov. So Gunnar and Nicolas, to make an outlook for 2020 3, what will be the main milestones during the year.
Of course, to see the full data from the mesotopic hand trial. Of course, also to see the recruitment of the Piripemat study. And then of course, we are, as I guess everyone, you included, we're expecting to see the decisions to be taken by Ipsen based on the data from the mesopoderm trial.
Okay. And
if I can add also to move the preclinical programs into Phase 1. And also we plan to present more information around During the year and that to us as a call us research nerds that that's a quite important thing for us. It's a really interesting program. So we hope to be able to disseminate more information on that as well.
Thank you. And that sums up today's broadcast and I wish you best of luck and also with your important studies of course And thank you, people that have been watching, and please welcome back.
Thank you.
Thank you very much.