Pharmaceutical company, IRlab, transforming life for people with Parkinson's and other CNS disorders, have closed its book for the Q3 in 2022. We will now be giving a presentation of the company and the reported quarter, followed by a Q and A session. Viewers can also ask their questions in the live chat. Participating from the company is CEO, Richard Godfrey Nicholas Waters, who is Executive Vice President of R and D and CFO, Victor Siewert. So with no further ado, over to you, Richard.
The stage is yours.
Thank you, Matthias, and good morning. Welcome to our Q3 presentation from UrLab. Firstly, may I draw your attention to our disclaimer and our forward looking statements made in this presentation. So the purpose of today's agenda is to give an update on the quarter and our business operations, to provide an overview of UrLab and also to run through updates on our R and D and financials. But specifically, what we'd like to do in this presentation is give a thorough review of our clinical programs and offer some guidance on the anticipated top line data from mesdopetan trial, which we anticipate at the end of this year.
So during the quarter, my first operational quarter as CEO, we really did make very solid progress on our clinical, preclinical and research In July, we announced that we expanded mazopitan Phase 2 trial to 154 patients. And in September, we confirmed that recruitment was complete. So we have a high level of confidence that there should be top line data available at the end of this year. At the same time, our partner Ipsen initiated 3 clinical pharmacokinetic studies, which will provide data to support later stage clinical development. We continued with our ambition to raise our profile and were very visible at multiple events during the quarter.
And there was an increase in our share capital related to the acquisition of some know how for one of our research projects. Our finances remain in good order. We had a modest sales of SEK 16,000,000 related to our ongoing business relationship with Ipsen. Our operating costs in the quarter were SEK 40,000,000, SEK in line with previous quarters and we closed the quarter with a very strong balance sheet SEK 292 1,000,000. So our balances are in good shape.
We've slightly increased the number of in our organization as well by adding someone to our R and D group. So in a snapshot, what is UrLab? UrLab is a clinical stage biopharmaceutical company based on really deep and profound understanding of Parkinson's disease out of the University of Gothenburg and the research by Nobel Laureate Professor Arvid Carlson. Today, our activities are very focused on developing novel first in class treatment for patients with Parkinson's disease. Our technology, our products and the business case with our products is truly validated by the license that Ipsen has taken for our lead program, misdopitan.
We remain in control of 4 unencumbered assets that we continue to develop 3 clinical development, each one with blockbuster potential. And our organization remains very well positioned, very experienced team, strong balance sheet and listed on the Stockholm Exchange. So for those who are not familiar with Parkinson's disease, here's a quick recap. It's a chronic and progressive neurodegenerative disease with no cure. It's characterized by these cardinal symptoms, rigidity specifically in the morning, Postural instability, bradykinia and tremor.
And it's all caused by a loss of brain cells that produce a chemical, A neurotransmitter called dopamine that has a pivotal role in controlling how the brain regulates movement. And you can see on the right here how The little dots are dopamine and how they facilitate communication between the neurons or the brain cells. Dopamine is also lost from other parts to the brain that you can see in this sketch in blue and green and gray and indeed also from other parts of the body. But we're fairly focused on enhancing the symptoms that otherwise patients would suffer from. We've included this slide for those who are not that familiar with the disease, and I do not intend to go through it line by line.
But what we can really understand is why it happens, Why it's important, the patients that are usually affected by it, the fact that it's driven by environmental factors and some genetic factors. But really what I'm focusing on is the fact that the current standard of care, a drug called levodopa, is quite effective but not without limitations. And indeed, there is no treatment available for one of the most troublesome symptoms of Parkinson's disease, and that's postural instability and falls, where we think we have a solution with paripanat. The trouble with Parkinson's disease and the standard of care levodopa Whilst it works very well in the early stages, as illustrated by the black box in the chart here, what we can see is after maybe 3, 4, 5 years, This actually becomes quite intolerated, and we have this breakthrough, dyskinesia, which becomes quite a problem for the patients. And indeed, as the disease progresses, becomes more and more of a problem.
This is the found sorry. Parkinson's disease remains a disease with growing incidents, Maybe 6,000,000 people in 2015, maybe 9,000,000 people today and estimated to be 12,000, 13,000,000 people by 2,040. A few years ago, the BMJ, the British Medical Journal, published the top ten priorities for treating and caring for patients with Parkinson's disease. And what we can see on the right here, they included things like number 1, impaired balance and increased force frequency, cognitive decline, Motor complications, the levodopa induced dyskinesias and non motor symptoms such as psychosis and anxiety. And what we can see On the right here of the therapeutic attempts that her lab is having to address these treatment priorities for these patients.
This is the foundation for our pipeline. We're developing a portfolio of therapeutics to treat patients with Parkinson's during their disease journey. We know in the beginning patients are greeted with bradykinia, rigidity and tremor. We're seeking in our research program to develop a 1 a day program to address this. After 5 years or so, as I just mentioned, bradykinje breaks through Levodopa induced dyskinesias and psychosis and Ambe's dopetam program is aimed at addressing that.
A few years later, patients start to suffer with cognitive decline and apathy. And our research programs 942,757 are designed to address that. And Possibly one of the biggest problems is postural instability, loss of balance, increased fall frequency and Piripemat is designed to address that. So we really are developing a suite or a portfolio of therapeutics to really help the Parkinson's patients during that disease journey. And all of this is possible because of our unique and proprietary research engine ISP.
This uses advanced systems biology, Phenotypic screening and machine learning to inform our chemists on how to design and develop the optimal drugs that are going to address these symptoms With molecules of the best biological fit. This truly does allow us to deliver 1st in class molecules with very strong patent protection And what we're seeing is increased probability of success going through the stages of clinical development. And with that introduction, I'd like to hand over to Nikolas to give you an R and D update specifically on our clinical programs. Thank you, Nikolas.
Thank you, Richard, for that introduction. I will now go through some information, which we've shown before on mestopetam. And mestopetam is a drug designed to treat dyskinesia. As Richard pointed out, this was one of is one of the biggest problems in the treatment algorithm for Parkinson's disease today. And as pointed out earlier, levodopa is the mainstay treatment for all most Parkinson patients across the globe today.
40% of all patients enter up into the state of dyskinesia, and that occurs around 4 to 6 years after the introduction of levodopa according to the literature. The number of patients are quite large. We see more than 1,000,000 patients across the different regions on the globe, which have this problem on a daily basis. And the patient population we are targeting in our clinical development of mestopetam, which we are pursuing in partnership with Ipsen, Our patients who have what's called good on time, that is when levodopa works well during the day, about 6 hours of that day. And then 6 hours of what is called bad on, bad on time, which is on time with dyskinesia, which, of course, hampers quality of life a lot.
And the objective for our Maesta Upadam program is to reduce to bad on time as much as possible for these patients by converting bad on time to good on time. The molecule discovered using our ISP technology is designed to treat dyskinesia. It does so by inhibiting a dopamine receptor called dopamine D3, discovered in the 1990s actually. This is a molecular receptor which acts radically in response to levodopa after chronic treatment in animals, but also in humans, of course. And mesdopetam has the ability to inhibit the excess dopamine produced by levodopa in the wrong places of the brain.
And doing so reduces dyskinesia. And We have shown in preclinical studies that mestopadon has a clear and highly efficient anti dyskinetic effect, but also in antipsychotic property at the same doses. And in specific assays, we also see cognitive improvement, which could be associated with the D3 antagonist effect of mastopetan. We have pursued a clinical development program to get to the final product with Mesto Pertam. Starting with Phase 1 studies, single ascending and multiple ascending doses in healthy volunteers a couple of years back, We discovered there that the drug is tolerable, has good PK properties and a safety profile, which is acceptable.
We went on to do a small Phase Ib study in Parkinson patients in Scandinavia. We also there could conclude that mestopidam can be safely administered to Patients with Parkinson disease and advanced stages of Parkinson disease. These are very severe patients that we're looking at in this Phase Ib study. We also got signals of efficacy on the scales that were used in that study, showing an antidyskinetic effect while leaving normal levodopa the wanted effects of levodopa working. So There we had some kind of guidance towards a larger Phase IIa study, which we conducted a couple of years back, A larger study, which we mainly pursued in the U.
K, double blind placebo controlled study, where we looked at a number of different doses and the effect of levodopa. We also can conclude from that study that the molecule is tolerable in this population, a good safety or safety profile. And we also saw very clear efficacy on the dyskinesias and especially improving daily good on. And we could see somewhere between 2 3 hours of improvement in good on, which is has not been seen in any study before. We are now conducting a Phase 2b study, which Richard alluded to.
We will conclude that study during the winter, and we'll have top line data at the turn of the year. This study is powered sufficiently powered to detect effects which are clinically relevant in this patient population. For the further development into Phase III and eventually marketing, Ipsen has all the rights and, of course, all the decision making to do around this program. Looking back at the data from the Phase IIa study, once again, we could clearly see a Reciprocal improvement in good on on the expense of bad on across the different doses in the study. To go from 2.5 to 7.5 milligrams, a clear increase in good on at the expense of reduced bad on, which is the wanted effect.
Higher doses does not increase the efficacy, which is not Surprising given the literature around the D3 receptor and well shaped dose response curves in a number of assays. So what we've done in the Phase IIa. It's basically defined the dose range that we're using in the Phase IIb study conducting right now. And we have also built on the safety and the diverse event profile database. And what we have learned is that the Side effect profile of mestopotom is basically on par with placebo as far as the Phase IIa study goes, illustrated in the table at the bottom here.
So the current study It's an ongoing study. It's a 4 arm study, placebo and 3 different doses, fixed doses of mestopetan. We are looking at a 3 month treatment period, which is 2 months longer than previous trials, and there's a 1 week follow-up after cessation of treatment. And we are looking at the primary endpoint as good on time through reduction of bad on time. Some guidance on the expected outcomes of this trial.
Of course, there is a long list of endpoints that we are analyzing post database lock and analysis. However, all that cannot be collected in one chunk. So What we expect to be able to produce as early as possible with the information around the top line results is The primary endpoint, of course, change in daily hours of good arm without troublesome dyskinesia. That is the primary endpoint. We will discuss the significance of this effect, the statistically significant, and also the clinical relevance of this effect.
And the full account of the study will be presented at medical congresses during the spring of 'twenty 3. To give some background to clinical relevance, we have put together a table here just illustrating what recently approved drugs in the space have been able to produce. Most drugs that are developed for Parkinson's disease are targeting Good On. Good On is the endpoint for any improvement in the treatment of Parkinson's disease. And as you can see in this table, There are a number of compounds here which have been approved based on around 1.5 hours of improvement in Good On.
The thing here is that all these drugs, they collect the improvement in Good On from reducing off time. And as you can see in the graph, off time comprises around 4% in this specific in our specific population that we are targeting. And that's less than the 6 hours of bad on, which these patients suffer from. So with misdopetam, we intend to change bad on time to good on time, as said before, while all the other drugs approved to date, except for amantadine, I'll come to that, reduce off time. Even as little as 0.7 hours have been approved in the recent filing.
And there are a number of Formulations of levodopa in the pipeline right now, there are 2 programs where there are submitted NDAs, improving on time with about half an hour or up to 2 hours, 1.7 hours roughly. The improvement in Goodon that these drugs and treatment strategies have It comes also with problems, and that is increased in most cases, an increased incidence of dyskinesia, which we are trying to treat with mestopetam. So in this context, mestopetam sticks out quite a lot with converting bad on time to good on time instead of converting off to good on time. Amantadine, a drug which has been used since the early '60s as a treatment for Parkinson's disease, is also has antidyskinetic properties. It combines effects on off reduced off time, about an hour, with reduced peak liver dose dyskinesia by around 1.5 hours.
So In summary, if one looks at the documentation published around 2, 2.5 hours of improvement. So there you have the background data, which illustrates what is clinically relevant and also acceptable to regulators. Talking about amantadine, of course, we've done comparisons. And in preclinical Assays, we can see that mestopetam actually has a better effect than amantadine on dyskinesia And as Richard pointed out, we also have this program out licensed. We are working together with Ipsen to develop this compound to a final product.
In and we have completed one of the largest deals in Swedish Biotech history around this asset. Moving on to Piripemat. It's a drug which is, as Richard pointed out, It's designed to improve balance and reduce falls in Parkinson's disease. We are currently running an international placebo controlled Phase IIb trial, and this is a wholly owned asset. Reducing falls is one of the greatest medical needs in Parkinson's disease.
Roughly 45% of all Individuals diagnosed with Parkinson's fall on a regular basis. That's a couple of times a month. And then the reason for falling can be many, of course. But in principle, it correlates very well to the cognitive decline occurring in the later stages of Parkinson's disease. So the cognitive decline leads to impaired balance and falls, which leads to injuries and costs.
And the consequences of falls in this population are quite severe often with fractures and hospitalization. Hospitalizations are quite costly also, both for the individual who has fallen but also for society. In the U. S, a cost a full injury cost around $30,000 to treat. And this the market for or the patient population, I should say, Eligible for a treatment to improve balance is quite large, larger than the dyskinesia population worldwide.
The mechanism underlying Mesdaubert Elopiripmab's effects on Cognitive function but also on as a consequence, on falls and balance lies in the frontal cortex. And pyridmat was designed to specifically activate pathways and neuronal activity in the frontal cortex, which are hampered in Parkinson's disease relating to norepinephrine and dopamine transmission, but also acetylcholine transmission. Pirip Maat has a radio specific effect in these regions, which is unique. Hence, the WHO ANN, a couple of years back, proposed the name Pirapormat, which indicates that Piripemat belongs to a new CNS class just like Maasto Petain. So Pipmart combines antagonism, if we go to the target perspective, combines antagonism at 5 HT7 And we believe that this is a necessary combination to get to this very specific pharmacology relating to cortical strengthening.
It's been well tolerated in clinical studies, and those ranges has been defined for later stage clinical trials. Looking at the regulatory aspects, we have an ongoing study right now, which we have designed together with regulatory agencies, scientific advisors and for experts. This is a totally new regulatory path. There is no other compound or product on the market which have paved the way. So we have to work together with the agencies to actually Design the way forward to a potential registration of this product.
So with the EU, we have received the approval to run the study and all the ethical approvals. So the study is ongoing in the EU. The FDA advised us to conduct additional DMPK studies and in vitro mechanism studies prior to 9D. And we have initiated and soon completed all those studies necessary. We expect to have those finalized during this quarter.
The potential is, of course, very high with this program. Looking at the cost of societal costs and the potential effect of the compound combined makes that we have a quite interesting proposition for patients and for society and payers. This is also a program where we have conducted, of course, Phase I studies, single ascending and multiple ascending doses. We discovered that We had a sufficiently good PK property to move forward. We had we discovered also that it's tolerable.
We have a safety profile, which is acceptable to develop for further development. We did a Phase I study in elderly comparing the new a new formulation of the compound, the tablet combination to previous data on the Capsule we used early on, discovered that half life in elderly is slightly longer. We have a higher exposure in elderly than in young people. Important information when it comes to designing the First, the strength of the tablets, but also the dosing for the forthcoming larger patient trials. We also found that we have a sufficient tolerability.
We have a safety profile, which is acceptable. We saw a few patients with elevated liver enzymes in the Phase I studies, which occurred after treatment has been finalized. Then we've done a Phase IIa study, which I alluded to before, where we saw a quite where we see a quite I haven't alluded to that, sorry, which where we see a quite interesting profile in terms of efficacy. It appears to be safe and well tolerated in the intended patient population. And the we also saw here a number of individuals with liver enzyme elevations after cessation of treatment.
That's after the treatment period. And the interpretation here is that we have a Rebound effect with Perpemat following abrupt termination of the treatment. So likely dependent on excess sensitivity to norepinephrine in the peripheral systems. We have a Phase 2b study ongoing where we are looking at a number of endpoints. It's a double blind placebo controlled trial with 165 patients, and we are recruiting in France, Germany, Poland, Spain and Sweden at present, and we are looking at expanding into further countries and sites across the globe.
A recap of some of the results from the Phase IIa data, which are quite compelling to us. First of all, PIPMART is not intended to treat symptoms of the core symptoms of Parkinson's The tremor, radidity and bradykinesia, which Richard talked about, but the postural dysfunction. And we saw a clear effect on postural dysfunction. And this is these are symptoms which cannot be reached by any known treatment of Parkinson's disease, including levodopa. So we saw an increase in improvement in balance.
We saw a couple to that, of course, a reduction in falls in Patients who are defined as fallers in this trial. These effects Are thought to be derived from activation of cortical function. And in support of that, we also see a reduction in the apathy scores in the neuropsychiatric inventory that was used in the trial. We're looking at apathy. We also saw that in the UPDRS scales, I should mention.
So we have both the motor function and the neuropsychiatric effects Combining our belief combined gives us a strong belief that we have this cortical effect in these patients. The ongoing study is to evaluate false frequency as compared to placebo over 3 months. The secondary endpoints, of course, couples to the falls in such a sense that we measure cognitive function. We also look at Parkinson's disease symptoms, which is necessary in a trial like this, and of course, specific tests for postural dysfunction and then also classical CGI. So we can expect quite a lot of valuable information coming out from this trial.
The trial is designed as a placebo controlled trial. We have 2 different doses of Pirapimat, 300 milligrams and 600 milligrams daily. We have A dose escalation introduced into this protocol, differentiating it from the previous protocols and a dose de escalation at the end of the trial. And this is to mitigate some of the aspects of rebound effects that we've seen in the previous trials. There are also other aspects of inclusion, exclusion criteria, I should say, addressing the rebound effect in this trial.
So Moving rapidly into the preclinical and discovery or research projects, 942, where we are now looking at improving cognitive function and brain health in PD, but in also in neurology in a broader sense. And then 757, clinical candidate there too, to treat apathy specifically. And then we have the We are currently in lead optimization stage there, and we are looking at once daily treatment for Parkinson's without the troublesome complications that we've talked about a little bit today. So 942, the status there is that we are moving towards Phase 1 studies in 'twenty three. We are currently in IND enabling studies, as it's called in the U.
S. That means tox safety studies, regulatory and developing the CMC for Phase 1 next year. Similarly, IL-seven fifty seven is moving along towards Phase 1 next year. So these two programs are basically run-in parallel right now towards 1st in human studies. And the P003 program, where we are looking at once daily treatment for Parkinson disease, It's there to exchange the Levodopa, that's our goal here.
That's a long way there, but we'll start with moving towards the once daily treatment, which is the perhaps one of the most important aspects of PD. That is that levodopa has to be taken up to 6, 8 times a day, creates problems for the patients and therefore, Once daily treatment is necessary, we think. And we are nominating a CD this year. We are close to selecting our first compound in this program. And the objective here with the PW3 program is to have a full efficacy, long acting Parkinson treatment.
I will stop there and hand over to Victor to go through the financial highlights of the quarter. Thank you very much.
Thank you, Niklas. Some finances then. First of all, the geopolitical events and the global economies with the increased inflations and interest rates and so on is affecting us as well. We are not immune. We do see some cost increases from our suppliers, not to a very high degree and nothing that is alarming, but we do see them.
You could also see in our Cost development, if you look at our P and L, it seems like we have a lot less cost this quarter than we had the last quarter. But in the middle graph on this slide, you can see that most of that has to do with the operations or The things that we have been doing for Ipsen as part of our handover of the Mestopetan program. Our own costs, so to speak, are still at about SEK 40,000,000 per quarter and has been quite stable, as you can see, for the last 3 quarters. Going forward, we will increase our investments in the preclinical programs, the 757 and 942 programs and also the PWL3 program as well. However, we do have a strong cash position with almost SEK 300,000,000 in the bank at the moment.
To the right, you can see that our employee or our headcount has plateaued the last 3 or 4 quarters at about 30 people. And we are hiring more people as we're currently, but mostly as substitutions for people retiring. However, we look forward to recruiting and adding competencies to our company going forward as well. So a little more details on the figures. You can see that net sales are SEK 16,000,000, a bit more.
13 of those emanates from the upfront payment we received from Ipsen. It was about SEK240,000,000 and we took roughly SEK 25,000,000 of those, set those aside to cover the cost for completing the Phase to B study with mestoplatan. And we are matching those €55,000,000 with the cost we have going forward. So this quarter, we have taken back, you can say, 13 of these €55,000,000 And when the quarter ended, it was about NOK 9,000,000 left in that reserve, which likely will be used during Q4. And after that, if there are any more costs relating to the Phase IIb program, We will take that over the P and L as normally.
The other SEK 3,000,000 are other services that we have performed for Ipsen relating to the handover and of the program. You could also see in this table that we have increased the number of shares a little bit during the quarter and that has to do, as Richard said in the beginning of this presentation, It has to do with the acquisition of know how relating to the P003 program that we announced this spring. So going to our analysts, we are still covered by Red Eye, ABG and Edison. And I think that they will or I know that they will have some questions to us in the end of this presentation. And with that, I hand over back to Richard.
Thank you, Niklas. Thank you, Victor. Very nice presentations. I'll just carry on to close out the presentation now. It's been a busy quarter with other objectives, Primarily to increase our visibility and company outreach, very busy with media coverage and presentations.
And you can see a summary here of where we've been in the last The next quarter and indeed the early part of next year looks very, very busy as well. So you're going to see an increasing presence of UrLab at scientific, clinical and indeed shareholder and investor meetings and presentations. So just to recap, we have a very rich pipeline, including a portfolio of new agents to treat patients with Parkinson's disease. Mesodopitan coming to the end of Phase 2b has been licensed to Ipsen to address levodopa induced dyskinesia. Our unencumbered assets, paripemat, 942,757 and our research program, 3, continue very, very well in their development program with paripimat leading the way in a Phase 2b study and looking forward to taking 942 and 757 into the clinic next year.
We have a lot going on in our R and D function and therefore, we anticipate a very strong news flow in the coming year, year and a half, two years. So we have a table here of where we can anticipate some milestones in the Q4 of this year, first half of next year And indeed, second half of next year and indeed, multiple events that we've already committed to where you'll have visibility of UrLab and receive business updates. So in summary, the outlook. Well, as I've said before, and on joining IRLab, I can confirm, we have a very, very solid foundation for a biotech company. Our programs are developing nicely in the clinic and our research engine is very productive.
Our business development has really confirmed that the work that we're doing, the assets that we're creating are truly robust and of great commercial potential, illustrated with the Ipsen transaction. Building for the future, we can look forward to the data from mazdopitan and anticipate that May well take that into Phase 3 and further development. We will, of course, will continue with paripamat and the development of our other assets. And we remain in complete strategic control of these unencumbered assets to either develop them ourselves or indeed to partner for them. And we can even start thinking now about potential commercialization.
And I understand that Ipsen is quite excited about the potential for the commercialization of mizdopetan. So to summarize, AIR Lab, pioneering biology, particularly in Parkinson's disease based on ISP technology. Focused strategy developing assets for treating patients along Their journey with Parkinson's disease. Robust validation, we have 4 shots on goal, each one with the potential of being a blockbuster and a very, very robust organization and strong balance sheet to deliver on our R and D promises. And maybe with that, I should stop and we can open for some questions.
Thank you so much, Richard. This is the Q1 that you were reporting where you have been operational as CEO as HeartLab. What was that like?
Well, it's great to be here. It's a real privilege to have so much activity and so much good news to report. And it's really exciting to look forward to the next few months and indeed for next year.
Like you said, your balance sheet is in good shape. But when can we accept to sales to be more stable and on higher levels?
Well, I mean, sales as a biotech company, we issue few But hopefully very large value invoices. So we can anticipate that there could well be some milestone payments due in the future. We're not in full control of that. But the most important thing is to develop the value within our assets rather than looking to realize that straight away.
And on the cost side, you have multiple studies clinical studies going on over time. So are they more stable at the same level. Well I think yes
I understand. I think as Victor alluded to you know our R and D pipeline is rich. It is expensive. We're in a very good position at the moment. We have high value inflection points on the horizon.
So I think we're in good shape. But certainly costs will increase as clinical activity increases.
Thank you. What's your focus on this ongoing Q4?
Yes. My focus, of course, is maintaining and growing our visibility. So we've got excellent programs with great potential and we need we need to share them with a very large audience. So both in the industry context, in the clinical scientific context as well as in the shareholder and investor community. So I'm out and about very, very busy Sharing the news flow, the activities, the updates and the anticipated milestones.
I think that's really my priority, as well as helping Nicolas Victor and the Board with strategic direction.
Okay. And with that, I would like to hand over to analysts covering our lab. And first out is Sue Romanoff, Managing Director of Health Care at Edison. Please go ahead and ask your questions.
Hello. It's nice to see the UrLab team. Thank you for the Thank you for taking my questions. With Ms. Dopetom wrapping up, could you provide guidance on what A good top line result would look like?
And what are the key things to look for since this is such a complex area?
I can take a first attempt and maybe Nicholas can add into that, but morning, sir. Nice to see you. We think that a clinical relevant result would be an increase In good on by 1 hour. And where and of course, we anticipate and hope for much more than that. And again, I'll reiterate that The good on that we're targeting is at the expense of the bad on, which sets us in quite a different league.
So not only the patients Experience more quality time during the day, but they're actually experiencing less poor quality time during the day. So one hour will be a good result. We're hoping that we could achieve a lot more than that, But that would be a clinically significant outcome.
Great. I think there's a lot of movement here with the closing of mestopitam and all the preclinical activity. Can you give us an idea of the anticipated expenses? I think this is an extrapolation of the first question and what Victor kind of went through and maybe Anticipated patient counts for the new trials?
Well, we haven't actually offered any guidance on that. But I think to recap what your question was asking is What would be the dynamics of the Phase 1 studies in 757, 942? Well, one of the purposes of giving quite a comprehensive clinical update this morning It's to show that the well trodden path that InterLab has now taken in developing our 1st in class assets. Remember, these are 1st in class. No one has ever done this before.
We need to work closely with the regulators and ensuring safety and tolerability is the first objective and then looking for clinical signals. So whilst we haven't yet defined or indeed communicated the scale and scope of our Phase 1 studies, we should anticipate that they'll be in a similar pattern. So single ascending dose studies and then multiple ascending dose studies in healthy volunteers and then toggling into patient populations. So relatively small and relatively low cost Phase 1 studies are on the slate for next year.
Great. That's helpful. Thank you so much.
Good. Thank you. Thank you, Sue. The next analyst is Gonzalo Artyak from ABG Sundal Collier. Please go ahead, Gonzalo.
Hi. Good morning, and thank you for taking my questions. I have few of them. I will start with 1 in the Pirapimat study. You mentioned that you are aiming to expand countries to support a higher pace of enrollment And that in the U.
S, the FDA has asked some work before an IND submission. Could you explain a little bit of A little bit on that. And also if you expect to finish by year end 'twenty three even without the U. S. Enrolling patients?
To finish by the end of next year. We have a broad footprint across Europe where we're opening sites every week and enrolling patients. So we have a very good momentum building up in that study right now. It's not particularly unusual to see a slightly different position from European and U. S.
Regulators, we've seen that quite often before. And the U. S. Said, hey, why don't you just do some more DNPK and mechanistic work before you file an IND. So we've taken a bit of time.
We've done that work now. We anticipate closing those reports by at the end of the year. And then we consider whether or not we want to, whether we need to, whether it's advisable to open an IND, and we'll take that decision in due course.
Okay. Thank you. And another one on the Pirapema trial. You're also mentioning that the EVA require you to do the False recordings with an electronic journal instead of the paper journal as you're doing now in Europe. But implementing these electronic recordings did Did not work, right?
So could you explain why and also if this can limit the inclusion of the US into this trial and potentially to further trials?
Well, I think I understand that this was before my time, but I've had a had a thorough briefing on this. So this was part of the development of a first in class treatment. No one's ever developed a treatment to reduce falls and increase balance in patients. Clearly, If there was a magical device that could record that, that would provide sort of real time 20 fourseven data, That would be desirable. And that was sort of one of the first questions that the regulators, the FDA, I believe, was asking.
So we evaluated such devices in small evaluation studies. And we can all imagine some sort of wearable, one sort of device with an app. But there were a number of technical problems with that and not just with the device, if it was dropped or if it was left On the bedside table, then clearly that would skew results, but maybe that could be mitigated against. There was quite complicated software associated with These devices to ensure all the information was captured that didn't necessarily fit well with an elderly patient population or indeed the typical Carers that we're looking after these patients. But last but by no means least, none of these devices are validated.
So whilst they may exist, we may be wearing them all the Time in forms of iWatches, etcetera. They're not validated to perform this function. So it wasn't really viable. But we did listen carefully and work with the regulators to understand that. And indeed we actually went back to them saying, hey, many, many successful neurological drugs have been developed in the past Patient diaries, that seems to be the standard way of doing this, these so called Hauser diaries.
So we have a high level of confidence that that would be quite sufficient here, Particularly based on our Phase IIa data. So that's the agreement that we've come to with the regulators that we can use these Patient diaries, it's patient reporting outcomes as the way of capturing the primary endpoint.
Okay. Thank you. Thank you very much. That's useful. And the one last question is regarding your cash position.
You state that you kept cash runway for 12 more months. Does that assume any potential milestone payment from Ipsen once you finish the trial or that you provide top line data, you announce it?
I'm not sure that we've given any guidance on how long our CAS would last for, but We have suggested that we have 292 CAS on our account. And we can't bank on a milestone payment at this moment in time, but there certainly is a schedule of milestones that we can expect from Ipsen in the future. But our cash position remains strong. And as we alluded to in the first question from and indeed from Soe's question, the cost of the ongoing trials and the proposed trials fairly well fairly modest, fairly well controlled. So we think we're in fairly good position from a cash point of view.
Thank you very much.
Thank you, Gonzales. Master Steve. Thank you, Gonzalo. And now we have questions from an analyst sitting in the audience here, and that is Fredrik Thore from Red Eye, who will be peaking through a microphone. Please go ahead, Fredrik.
Thank you. So my question was also regarding that a bit about the mestopetal trial and the next steps of the Phase III trial? And when could Ipsen start the Phase III trial the earliest? Can you maybe just give us A time then of like the process until it did start.
That's right. Well, of course, we can't give any guidance on when Ipsen may or may not start a Phase III study. That would clearly be And the executive season be taken by Ipsen. But we are reassured by their eagerness as we have very frequent interactions with them, very close collaboration indeed both on the clinical, on the clinical preparation work and on the CMC. Indeed, some of the costs that we've recovered from Ipsen through sales have been related to that activities.
And we're also reassured by the fact that they At their own expense and at their own initiative have initiated these 3 pharmacokinetic DNPK type studies, drug drug interaction studies, which is all very, very valuable contributing information for a later stage development. So they're very eager, but I can't give any guidance when they may or may not Decide on the study.
Okay. But like theoretically, could it start quite quickly? Or like is this like mechanically a long process with all the steps after you get to that? Sure.
I mean, in my experience initiating clinical trials, once you've got everything in place, the quickest you That would be maybe, I don't know, 6 months maybe.
Okay. Yes. I guess I'm fishing for a potential milestone payment. But okay, so the next question a bit was about I I mean, you mentioned in your presentations the U. S, EU5, Japan and China's potential markets.
But With Ipsen as your partner with at least the Mastopetan project, can you maybe develop a bit on What type of markets could you reach when it comes to the sales? Could it be all of Europe, other Asian segments?
I understand So Ipsen's got very strong sales representation across Europe and very strong in this particular therapeutic space across the United States. They have a growing business in China, we understand, and a presence in Japan. So I think there will be a little bit of growth in their distribution With the valuable assets such as the mesdopetan, but they're very eager to put all of their sales efforts behind this. And that's one of the reasons why They were selected as a partner. They're small enough, they're dynamic enough and they're eager enough to really get behind this asset.
And they have a very strong footprint in Europe and a very specific but targeted sales force in this therapeutic space in North America. So we have a lot of confidence that they deliver on their sales ambitions.
And maybe a reminder to Middle East, but Niklas mentioned in the presentation the power calculations. Did those change when you expanded the trial a bit this summer? Or Is it the same assumptions that we should expect?
Yes. The power calculations remain the same, but having the optimum the maximum number of patients permissible within The protocol just gives us greatest confidence that we're going to achieve the endpoints that we want. So we won't be, if you like, sort of at the bottom of the end number in order to deliver that. So We took that decision to well we had time, we had such momentum in the recruitment that it seemed foolish to stop short for the sake of a few months when When we can actually get to that 154,000,000 which was the maximum permitted by the protocol. So we took that decision.
And as you could see, just a few weeks later, we closed out because it was fully recruited. So That was definitely the right decision to take.
All right. Richard, that kind of wraps it up for the day. Thank you so much for joining us, and good luck with all your studies partnering discussions and so on.
Very good. Thank you, Matthias. Thank you for