Reported for the Q4 of 2023. And the company will now give a presentation followed by a Q and A with Equity Analysts. Viewers can also ask their questions in the live chat. So to present the Q4 of 2023 in the digital studio, I I'm happy to hand over to CEO, Doctor. Gunnar Olsson.
Please go ahead.
Thank you. If you could have the slides, please. Good morning and welcome To the Q4 and end of year report from IRLab. Next slide. Today's agenda, I would start by giving you news from the period.
That will be followed by an R and D update by Niklas Auters. And then Victor Silberts will give an update on the financials. I will then come back And give you some concluding words and looking into the future. And we will then end with a Q and A session. Next slide.
Operational highlights during the Q4. For Mesdopetan, in October, we initiated a collaboration with Clintrex, our U. S. Regulatory and Clinical Strategy Advisors and with the ProPharma Group, our U. S.
Regulatory agent. And the collaboration was to prepare for an end of Phase 2 meeting with the FDA. In mid December, we submitted an application for such a meeting and the FDA granted The meeting and the date was set to February 20th this month. Next, please. For Piritmab, IRLAB was granted an additional new patent for the drug That is used in the ongoing clinical development program.
This patent runs into 2,038 And it has the potential possibilities for extension that would lead to a potential market exclusivity into the early 2040s. Next slide, please. For 757, we completed The preclinical development activities and we've started compilation of all the data for a regulatory submission to have permission to start our clinical Phase 1 studies. IRLab was selected To receive a grant of US2 $1,000,000 from the well known and well reputated Michael J. Fox Foundation To support the development of 757 for the treatment of apathy.
And we have now Also contracted a CRO to run the Phase I study following the regulatory approval. And we anticipate the start of that study will be in Q2 this year. Next, please. Business Development and Financial Activities. We held a Capital Markets Day in October in Stockholm, where we presented the portfolio development as well as the growth strategy for the company.
We participated in the Bio Europe in November in Munich, and we have now A lot of follow-up discussions with companies that we met at that meeting. Investor meetings, We have participated and presented at 5 investor conferences and we've had Continuous discussions with our financial advisers and investors. We increased The liquidity with a loan facility of up to SEK 55,000,000 in December and this is To extend our financial runway and of course increase our business opportunities. Next please. Other highlights from the last quarter.
With regard to myself, My appointment as CEO was extended into this year in December. We have recruited Friedi Karlsson as a new Director of Clinical Science and Biometrics, and he joined the company 1st January. This is, of course, a good strengthening of our clinical capabilities since we are now seeing more focus coming into the clinical phase. Next please. Events after the period with regard to period math, The study has now come to a point where we can start generate new insights from the ongoing clinical study.
We have observed that during the 1 month baseline period, fall rates are higher and they are more Stable than we anticipated before initiation of the study. We have come to a point where we see a steady recruitment rate Following opening of all the centers from late May, we have very positive patient feedback back And we have had repeated requests to continue medication also after the end of the study period. And all in all, this gives us the ability to drive data driven estimates for more accurate Study timelines. And based on this, our data driven estimates today states But we have patient recruitment to continue into the Q3 2024. And Probably absolutely important to us.
It also shows that we have a higher probability to detect treatment effects Based on the observations on higher fall rate, more stability during the run-in phase and The lower dropout rates that we have seen. Next, please. Scientifically, we have now 2 abstracts accepted for presentation At the 18th International Conference on Alzheimer and Parkinson's Disease in Lisbon now in March. The first abstract will give a detailed description of the REACT PD, the Phase 2b Please start with pyritmat. And the second abstract will give a summary of preclinical observations of 11 17.
And this is the first time that the company reveals data at the scientific conference With regard to the 11/17 compound. Next, please. Hi now to Shift and I invite you Nikolas to give us an already update please.
Thank you, Gunnar, and thank you, everyone, listening today. I'll give you a brief update on the progress in the programs during Q4. Next slide, please. As you all know, we are a company focusing heavily on Parkinson disease, but not exclusively of Parkinson. And in PD, there has been Very good treatments available for the past 60 years in the terms of various formulations of levodopa, which treats the basic symptoms of Parkinson's is tremor related in bradykinesia.
However, there are a number of issues which are not dealt with in Parkinson's. And Michael J. Fox Foundation recently published a survey. They have been asking patients across the globe now for since 2017 actually, asking questions about their priorities in terms of treatment. And this is the slide here shows A excerpt of that data indicating that balance falls instability is still A huge problem or is the biggest problem for these patients.
But there is also problems in the basic treatment of Tremor, radiculity, bradykinesia, the hallmark symptoms of Parkinson's. And then we have the neuropsychiatric aspects of Parkinson's, which are not dealt with properly. And that is Treatment of cognitive function, but also mood aspects where apathy falls to some extent. And all these Issues, they align with the areas that IR Lab is focusing on. Next slide, please.
These symptoms, they come and they grow over time During the course of the disease, the 20 years roughly 20 years of disease and indicating that next slide, please We are addressing all the on next again, next again, that's Peter Pemart And next again. And next again, sorry for this. There you see. We are covering all the aspects of which are Poorly or not treated at all today with our pipeline, if both 942-757 Mesta Petam and 11/17. Next please.
Mesto Petarm, a brief update on the status there. Next slide please. This is a first in class compound with a novel mechanism. There is no other drugs that we can see in the clinical development pipeline globally, which addresses the same kind of mechanism. This is a mechanism which has been implicated In the genesis of dyskinesia in lots of literature in the past few years, MSDOPOTOM is an antagonist at the dopamine D3 receptor, so it Inhibits over activation of D3 receptors.
We have built a patent portfolio around the asset, which Has the potential to protect exclusivity into the 2040s. The lead indication for mesdopetam is Levodopa induced dyskinesia, which is an undertreated complication in Parkinson's disease across the globe. There are additional indications that we can consider also for Mr. Hopatam, such as psychosis in Parkinson. Next, please.
The progress in the program has been quite steady during the fall. We started to work towards an end of Phase 2 study in September, October of this year And last year, sorry, we have compiled the so called briefing book, which is the Documentation that the FDA needs to be able to assess the utility of the product and the to discuss the further development of the program. So we have together with our collaborators in the U. S, Our colleagues and friends at Klimtrex and PPG developed this briefing book. We submitted that actually on the 4th January, so it's in this year.
The objective of the end Phase 2 meeting is to get alignment with the U. S. Regulators concerning the forward further development of the Phase 3 program for Masto Berton. We expect that we would have some sort of written Response from the FDA about 30 days after the meeting, and the meeting is, as I said, on the 20th February. Next, please.
The briefing book has is built around all of the studies that we've done with Mestopetan From the early preclinical IND enabling studies, the long term tox studies, the CMC development, That is the development of drug product and drug substance. And then we have the Phase Ib studies Indicating this anti disconnection safety, we have the Phase 2a study, which indicated further anti disconnection properties, But also expanded the safety and tolerability database and more recently the Phase 2b study. And in parallel with the Phase 2b study, we conducted a number of Phase 1 studies necessary for Continuing with Phase 3, that is so called drug drug interaction studies that is studying how Mestopetone works together with other types of drugs that are used in this population. And then also the so called mass balance that is Following where mestopertan goes in the body and how it's taken care of and when it comes out. These are very important studies to complete the package for an end of Phase 2 meeting.
We've also studied pharmacokinetic properties In different populations, special populations, that is Asian versus Caucasian populations. And we can conclude that there is a very consistent pharmacokinetic properties across all populations with MSD overdone. Also in the Phase 2b study, we saw a clear signal of antidiskinetic efficacy And a very, very strong safety and tolerability package. So next step here is the end of Phase 2 meeting to be able to actually Properly define the Phase 3 program for the product. Next, please.
Paper Mart, this is a drug which actually addresses the biggest problem in Parkinson's disease, Falling or balance issues and falling. Next, please. Where we have an ongoing Phase 2b study, as you are aware. Why is it so important to prevent falls in Parkinson? Well, about half of all Parkinson patients Fall recurrently during and this is in the later stages of the disease, of course.
But This also shortens the lifespan for patients. And the reason that patients fall is a loss of Function in the cortical areas of the brain. So you have cognitive decline, you have impaired balance, which leads to falls and then, of course, injuries and costs. Next, please. So also PirapMoth is the 1st in class drug with a novel mechanism.
Like MestoBaton, PirapMoth Defines a new class of CNS drugs. This is very, very important aspect of the program from a commercial perspective. Then we have the mechanism, its novel mechanism inhibiting alpha-two and serotonin 7 receptors. And the combination there leads to a very strong activation of cortical neurotransmission and cortical functions. Also here, we have patent based exclusivity portfolio patents covering the asset, which could Next, please.
Also here, we have built a Package of studies or a series of studies building towards the pivotal studies With, of course, Phase 1 studies initially, besides all the preclinical development, CMC, talks and safety Studies, we have recently completed the long term talk studies, 6 9 month studies. So we now have a complete package of toxicology data. We have a complete package of DMPK and safety data with the compound. In the Phase 2a study, we discovered that the drug actually improves cognitive function and reduce has the potential to reduce falls. We also saw some effects on neuropsychiatric symptoms such as apathy.
And we are now in the middle of The Phase 2b study, which Kona alluded to, we have done some interesting observations in that study, which helps us enormously in terms of completing the study. And this study evaluates the effects of full frequency, balance, postural dysfunction and also cognitive and neuropsychiatric endpoints. Next, please. What we have discovered looking at the baseline data, so just Brief on the study outline. Patients are selected for the study by the sites that are 31 or 38 of them now run across Europe that knows their patients well.
They are recruited into the study. And then we measure for a month, so to say, measurement of the number of falls in these patients. And that month is then followed in the best in most cases, is followed by randomization. That means that the patients are then given placebo or either of 2 doses of Pirpemod for 3 months. That is followed by a number of follow-up visits and then data management.
But what we have seen now in the data so far in the baseline data, And of course, this is blinded. We see that the patients fall 2 to 3 times more than Previously anticipated and the anticipations are, of course, based on literature data, but also on surveys we did before the study was started. And this means that we have a much higher baseline of falls. And if we have a higher baseline of falls, It's much easier to detect a reduction of falls or an increase of falls actually, if that should occur. So that's a much better outset for the statistical analysis, which means that we now believe that We may be able to reduce the number of patients in the study.
We've retained our so called power to detect an effect. We expect next, please. We expect The study to be concluded now in terms of recruitment in August or in Q3 this year. And that is based on the fact that all clinical centers are activated since May last year, and then they're pushing the recruitment Quite hard right now. Looking at the cost of falling, it's quite substantial.
We have discussed this before. But In the recent publications from the CDC, about US32000 dollars per patient ending up in hospital. And of course, that comes with a lot of problems for the patients and the caregivers also. So there's a high cost to falling. I mean, if we can reduce that just a little bit, it would help these patients in this population a lot.
Next, please. A few words on the development of the preclinical programs also. So So if we start with the next slide, 757, to treat apathy. And apathy is one of the most Common neuropsychiatric symptoms across neurological indications, Parkinson, Alzheimer, frontotemporal dementia and you can go on with a long, long list. So this is a drug which is not only confined to Parkinson, but we, of course, have a focus on the issues for Parkinson patients.
And as Gunnar mentioned, we were we received a grant from the Michael J. Fox Foundation who thinks that apathy is We've got a $2,000,000 grant from them to run a Phase 1 study for a series of Phase 1 studies. I'll come back to that. As you can see, there's a lot of patients available with this, The estimations around in the largest markets across the globe is about between 1,700,000 patients and also the families around them. And we expect to be able to start IND we are in the middle or we have completed IND enabling And we will start Phase 1 studies during Q2.
For 942, which is developed in parallel with 757, We are right now in the IND enabling studies and we expect to have it Phase 1 ready by this year. And cognition is a huge issue for Parkinson patients and also in other neurological There is one treatment available, cholinesterase inhibitors, which are approved, but they lack efficacies and are not very strong and they have a lot of We think that there is place for a good or a better treatment for cognitive dysfunction in Parkinson's disease. And lastly, but not least, at all, 11.17, I'll come back to that, a totally new technology to treat The basic symptoms of Parkinson's disease. Next, please. So, the progress in Q4 with 757 is that we actually have now compiled all the documentation needed for a CTA or a clinical trial application In the European Systems, where we will start to apply for to get approval for Phase 1, We have completed the CMC development for Phase 1.
And as I said, we have funding for the Phase 1 studies. And this is a quite substantial Package of Phase 1 studies. We start with a single ascending dose study and move directly then into a multiple ascending dose study Over 9 days. And then we look at food interaction all in one package. So it's a quite substantial Comprehensive Phase 1 study package that we are running together with the Michael J.
Fox Foundation. And that is to prepare for proper Phase II or Phase Ib, Phase IIa studies. Then we have 942, which also has the potential to be the 1st in a totally new class like 757, once again, 1st in class to improve cognitive functions. The development there proceeds according to the plans that we have laid out. We are right now in the middle of Finalizing the CMC development of API and drug product for further studies, we plan to initiate talk studies this year, The 1 month stock study is to be able to compile the documentation by the end of the year.
We are right now in discussions with, as you know, with MSR DeJort Zuker for the further development of Any of these or both of these assets. Next, please. 11/17, Which is a really interesting product or project where we have discovered a technology where we can actually We get sustained efficacy over a much, much longer time than you can get with Leavodopa. And I'm showing here a graph and this is An excerpt from the poster actually that we will show at the ADPD Congress in Lisbon in a month's time. The graph illustrates the oral administration of 11.17 and then you see the Sustained activation of motor function and this is in Parkinsonian rodents in rats which are have Parkinson's disease.
And this should be contrasted then with what you can get with levodopa, for instance, you can get About 2 hours activation of motor function in this type of model and with apomorphine slightly less, about 1.5 So those 2, apomorphin and levodopa, are the most used antiparkinsonial treatments today. So here we can actually provide a once potentially a once daily treatment for Parkinson, which would simplify the Improvement improve the treatment dramatically for patients. This also has the potential to be the 1st in a novel class. We don't know of any similar compounds in the development pipeline based on the same technology that we have developed. And the one of the key issues here is that we have rapid onset with the drug.
That's really, really important for the patients, rapid onset and long standing efficacy. We're working on the development of CMC. This is a highly potent compound. So there are specific Next, please. Victor, I'd like to turn over to you to give a brief on the financial situations.
Thank you. A few words on the financials. So next slide, please. So if we go through the panels at the bottom, to the left, we have the cash flow, Where we can see that we basically had the same amount of cash in Q4 as in Q3, which, of course, it is due That is a loan that we took in late December. In the middle, you can see the cost structure And you can see that we have decreased costs during the last four quarters, and that is, of course, due to a lot of activities being finalized, Such as the Phase 2b study with mastopetavone and also the 757 project, which is now Phase 1 already, where we had some costs During 2024, for example, for toxicology studies and so on, which are now paid So, that is good in the current financial climate.
We Do keep our personnel. We believe that they are very important. So we are still maintaining about 30 employees in the company. And as stated in the bullets, the cash position was about SEK111 million at the year end. Next slide, please.
So this is just an excerpt from the Q4 report where we also see So the cash flow is a little bit less than last year and that we have SEK111,300,000 in cash. That's all about the numbers. So back to you, Gennard.
Thank you, Gektor. Next slide, please. So some concluding words and some looking into the future. I'll start by reminding you of our strategy. We are addressing all stages of Parkinson's disease and also other CNS disorders.
We're discovering novel candidate drugs with our unique ISP platform and that gives us True innovation, a higher success rate than industry standard and it gives us a very strong IP position for our compounds. We're developing our CVs from discovery up to clinical proof of concept. And then we are seeking partnering To run the Phase III and future conversation of the drugs. Next, please. This year, or I should say, the last year 2023 Has been a year of very major progress in the pipeline.
And let me summarize you In this from this slide, with mesdopton, we started the year by getting the readout and top line results Over the Phase 1 Phase 2 study, later in the year, we secured the full ownership and all rights To the product, we took it to Phase 3 readiness and we have now a scheduled end of Phase 2 meeting later in this month. For Piripemat, we have the ongoing Phase 2b study. All the clinical centers were opened. We had the 1st pre specified DSMB evaluation of the study. And As I stated before, we got a new patent granted that potentially extends market exclusivity into the 20 Early 2040s.
For 757, we completed our preclinical development program. We received a grant, US2 $1,000,000 from Michael J. Fox Foundation. And as Nikolas pointed out, it will finance the 1st in men study that includes a SAD and the MAD And food interaction study in 1 study package. And we will start the Phase I study In the Q2 this year, for 11/17, this compound Was selected last year, and we took it into preclinical development phase.
For 942, We have the ongoing development activities progressing according to plan. With regard to the portfolio, we have now created a world leading position in Parkinson with our Project portfolio. Some words on business development. This was a year where we really increased All our business development activities and we have multiple opportunities that are evaluated. Next, please.
And this has led to the following pipeline table. At the top, you see MSD optan, lead indication, treatment of lids, Phase III ready program And then of Phase 2 meeting with the FDA in the next 2 weeks. Piretmab, The lead indication treatment of falls in Partizone in Phase IIb and With study enrollment completed during Q3 this year. 757 For treatment of apathy, now Phase 1 ready. We anticipate start of Phase 1 through the second quarter This year, the 942 to treat cognitive impairment in preclinical 11/17 in preclinical to treat Parkinson's disease, male Symptoms, both these compounds where we anticipate to have them Phase III ready during the year.
Next. Some words about business development efforts. With the intensified activities, it is now so that awareness of EASlab And the development pipeline we have, that awareness is increasing, and this is very good news. We have continuous and frequent dialogue with potential partners and we have partnering opportunities across The entire portfolio. However, in the near term, we focus on Vistortepan and 757.
Thank you, Lundqvist. Our key priorities, they are focused For value creation and to summarize them, in the clinical phase, it is, of course, the end of Phase 2 meeting with the FDA Later this month, it is to complete the recruitment for Phase 2b in the PRiMAT study And it is to initiate the Phase 1 study with 757. On the preclinical side, it is To make sure that we drive 942 and 11.17 for Phase 1 readiness. And with regard to financing, we need to increase our capital base to enable Further value creation and we do this through both business development activities as well as other financing opportunities. With regard to business development, we have a continued dialogue with potential collaborators and collaborate partners And we continue our dialogues with financial advisers and investors.
Next. When we look forward over the next 18 months, we have multiple possibilities for high value creation, Rich, you want to use the word inflection points or value creation. With Mesdopetal, it is the end of Phase 2 meeting with the FDA as well as the ongoing business development activities For Phase 3. For tirukimab, it is the completion of the study and Business development activities for Phase 3. For 757, it is The start of the first tumor study and of course also the completion of that study and the business Development activities to search development collaboration.
For 942, it is getting Phase 1. We are the Start Phase 1 and initiate development I should not say initiate, I should say continue The ongoing development collaboration discussions that we have. For eleven-seventeen, it is to be Phase 1 ready and get into active Phase 1 study. Next slide, please. So Ila, having now the world leading portfolio in Parkinson's To reduce the burden of the disease and to transform lives, we have pioneering biology And we have the unique ISP to generate our new molecules.
We have a focused strategy. We have a validated business model. We are discovering new CDs that we take to Clearly, we get proof of principle and we are doing deals. We have a broad and world leading portfolio of projects in the Pakistan area And we are an organization positioned for success. That's all for the presentation part.
Let's now move over to the question and answer section. Thank you.
Thank you so much, Gunnar, Nicolas and Victor for your presentation. It's always interesting and inspiring to listen to your progress and activities. It's time to start off the Q and A, and I will Grab 1 before we hand over to the Equity Analysts. So my question is this upcoming end of Phase 2 meeting and Phase 3 Ready Meeting on February 20. How time consuming is it for you and the management to perform this to prepare this meeting.
You want the long or the short answer? But The long answer is that we've been preparing for this since 2017, basically, since we started development. The but in the short term, the preparations are, of course, time consuming. However, they do not That's not to the expense of any of the other activities that we're running. The team is has been preparing The briefing book, together with external experts, a lot of good very, very good advice from our U.
S. Colleagues in how to compile the documentation from, as I said, the early development to now the late stage or mid stage development In a very nice package that took a few weeks during December, a lot of meetings. But and then right now, we are Reading in, studying our own data, refreshing our memories of things we did 10 years ago and 5 years ago And preparing for the discussions, and discussions are based on the number of questions Shows that we are posed to the FDA as you do in end of Phase 2 meetings.
And let me just add here. I want to commend The team that has done this because what I think you should all recognize that is that within less than 6 months, We have secured the ownership and full rights to the product. We have We've been transferring all information material from Ipsen. We have started new collaboration with U. S.
Colleagues. We have put together the briefing pack and we will have had the FDA meeting for end of Phase 2. I think that, that is a really good achievement by the term to do all this within less than 6 months.
Thank you. And by that, it's time to hand over to Alexander Kramer at ABG Sundal Collier. Please go ahead with your questions, Alexander.
Thank you. Good morning. Thank you for taking my questions. I have a couple of questions. I will start with the first one.
So the first one is about the end of Phase 2 meeting with the FDA as well. And I was wondering about the midterm prospects here. At your CMD last year, you talked about the possibility of having a special protocol assessment, SBA, to have an agreement on the Phase 3 design, do you still plan to have such a SBA in place? And what is the time line for such an agreement?
We are planning for an SPA to sort out details Of potential protocols for the Phase III studies. We cannot give a timeline on that At this time, we need to have concluded the end of Phase 2 meeting before we can actually go into that discussion with the FDA. But that will, of course, be the next urgent step to get that done.
Okay. Thank you. And another question is regarding the pyridipimat's REGPD study. And here my question would be, could you give us some color on the number of patients that you have recruited so far? How happy you are with the recruitment speed?
And also regarding the debt study is about the study amendment that you brought up in your press release. If such, what are the conditions for such a study amendment? And if such a study amendment would be granted In H1 this year, what impact will it have on the timeline on the whole process? Like how much is going to accelerate the process of finishing recruitment and top line data readout.
That was 4 questions in one. I understand. On the end, so that I can remember. And you'd have to remind me of the first one later on. But the time lines for the study, In the guidance we gave today, actually yesterday and today, we have built in any Further discussions with regulators on this.
But the benefit of what we have learned from the study leads The conclusion that we can actually reduce the number of patients from the originally thought 165. And you should all know that this The power analysis is based on a statistical assumption that you make before a study. However, now we have learned much more so we can actually refine the power analysis, which means that we can have the potential to reduce that. But that needs to be discussed with the regulators and that needs to be followed by a discussion on the statistical analysis plan. So those two things need to go hand in hand to be able to get to a conclusion.
But we built that in into the guidance that we have delivered today. So we don't expect to we do expect to be able to get the lost patients in by Q3.
Yes. Let me add here. For us as a company, the absolutely key priority for us that is to have a study That delivers results that helps us to take the next decision on investment on Continued development. And we are doing now absolutely whatever we can to really get to that position to have so much A strong position when we have the data coming out. So rest assured, we will communicate More details as we move forward and when we know more, but as Niklas pointed out, This includes interactions with the regulatory authorities and let us not speculate anything until we've had those
We want the responses from the regulators before we share the information that we have generated. That's a key thinking around how we communicate.
Okay. Thank you very much. That's it from my side.
Thank you, Alexander. Two questions.
Thank you so much, Alexander. And it's time to hand over the word to Sue Romanov of Edison Group. Please go ahead, Sue.
Thank you for the update. It was very helpful. And Alexander took some of my questions here, but can you give us an for Mesopotam, I think we talked about having a small program. Will the Phase 3 study be sufficient for the regulatory approval? Or Do you see a need to do a second study?
We know that the ground rules From regulatory authorities, including FDA, that is that they want to have 2 Phase III studies. However, there are exceptions And the FDA has published a paper where they describe those type of exceptions. Our advisers, they believe that there is a chance that we might only need one study. But let us keep this open. We have the meeting in 2 weeks' time from now.
We should not speculate here until we have I have the meeting and when the discussion of this particular question had been done with the FDA. So we will definitely come back on this.
And so when it comes to the size of the You asked about that also in the same question. So when it comes to the sign of the Phase 3 program, of course, that is something that we will know much more about after the and the Phase II meeting. But what we have guided so far is that based on the data we have generated, Phase IIa, Phase IIb data, We expect that roughly 150 to 200 patients would be enough for 1 Phase 3 study to be able to assess the efficacy on dyskinesia, but also an anti Parkinsonian effect of the compound. If you recall, our previous presentations, we've talked about the reduction of off time, which is really, really important. And we want to include that, if possible, Want to include that in the label?
Yes. So 150 to 200 patients per Phase 3 study, basically.
And importantly, The duration of the double blind treatment will only be 3 months? Yes.
So you have a lot going on. I mean, Like how do we think about the prioritization? I mean, I know you're working 20 fourseven here with even just the end of phase work, but Can you give us an idea of the way you think about on the prioritization of all your work?
I will only give you a very generalized statement. That is that, of course, the further you Have developed a product, they hired the priority to really take it all the way through. So that is absolutely important for us. Secondly, as I mentioned, we are doing a lot of activities to secure financing of all our products, A lot of business development activities, a lot of interactions with financial advisers and investors. So What we presented here today in terms of priorities and time lines, that is what the present plan Isabel, of course, if things would happen that are not under for a certain, We, as any company, would, of course, then need to look into the prioritization to see if there is a need to do any changes.
But What we presented there, that is the position we have for the moment.
Another way to respond to that, Su, is to say that We are devoted to developing all five assets as professionally as we can With the according to the time lines that we have set out to do them, and we have the Currently, the internal and consultant resources to do that. So That's another way of responding.
Yes. Okay. All right. Thank you very much.
Thank you, Sue. And it's time to hand over to Fredrik Toer at Redeye. Please go ahead, Fredrik.
Yes, and hello. Just first question to clarify, so I understand it correctly, And Niklas, you mentioned the recruitment being finalized in Q3 in the Piriform study. Was that with or without The potential amendments in reducing number of patients.
I can say that, that is independent of The guidance we've given is independent of the patient population number. It's based on the likelihood of getting Or retaining the power that we want to have for being able to detect an effect. Okay. Sorry
for
that. And the next question, you mentioned also that The higher fall frequency than expected. Does this mean that it's a slightly different patient population or just that You had to generalize that before or can you explain this a bit more how it could impact?
Not necessarily another type of I mean, when you start a study, you define the characteristics of the patients that should go into the study By defining inclusion and exclusion criteria. And according to those criteria, the expectation was that they should fall around 2 to 3 times a month, which would be enough actually to be able to see a reduction. But here we see 2 to 3 times more falling in the baseline month. And what is really striking is the consistency by the falling, the falling rate, The individual falling rate, it doesn't change over a 30 days period. It's the same every day, which is also helps in dealing with the data.
So what we've done is that we have been looking at the structure of the data and Trying to understand how to best assess a statistical model to the data Later on when we have the order data or even the treatment period, we don't have that.
And also maybe a final question here. You mentioned in the report that you had partnering meetings during the autumn and that there were some follow ups So in the spring summer, how dependent are these on the end of the phase 2 meeting? Is that what they Want to return to after you have more information from that or is the dependence?
Yes. With the discussions concerning Maestro Petain, I think it's pretty clear that most companies that we are in discussion with, they are, of course, eager to get the FDA feedback Before taking the next step. So I think definitely as you alluded to, things All dependent on the FDA meeting.
As they are for any product Obviously, at this stage, so that's not a strange thing. However, the groundwork has been laid out during the fall and the winter.
We think it's a very good sequence of events. We've had the initiation of discussions with other companies. They have looked into the data and they are now waiting to see the due diligence that the FDA has on the data. That is something that they will use in their decision making.
And actually maybe a Final question, the Michael J. Fox grant that was about the Phase 1 trial, how will that be recognized? Is that Depend on you starting the trial or finalizing the trial or how do you see that growth?
It's very simple. They fund the study. So when we start, they fund when we end, they finalize the payment or we finalize the payment So, it's very simple. Money out, money in.
Perfect.
And it's actually, I need to stress this. This is fantastic for the company be recognized by the Michael J. Fox Foundation. And also, the fact that they focus on the apathy Aspect of it, which has been a hidden problem for so many, many years and we've lifted that, they saw that and they jumped on it. I think that's really important.
Thank you so much, Frederic Thore at Redeye. I have one last question. It's also regarding the Michael J. Fox Foundation. You were granted US2 1,000,000 Dolores, will this take you through the whole Phase I study or even beyond?
This will cover the cost for the study. So it will take us through this year and part of next year. That is When we anticipate the study to be completed, so that's What will be covered by the grant?
Okay. So thank you so much, management team at Eyerlab, and we are all looking forward to the response from FDA around the 20th March. And good luck going forward, and thank you, everyone, that has watched.
Thank you.