24. We will get a presentation by the company followed by a Q and A with Equity Analysts and viewers can ask their questions in the live chat. To present today, we have IR Lab CEO, Gunnar Olsson Executive Vice President, R and D, Nicholas Waters and CFO, Victor Sievert. Hello, it's great to see you again.
Thank you. Thank you and good morning and welcome to the Aerlab quarterly update. Could we add the slides? Next slide, please. Next.
The agenda for today, that is that I will give you an update of the news in the period, and this will be followed by Nicholas Waters, who will give an R and D update. Victor Sievers will then give an update on the financials, and I will come back, with some concluding words before we enter the Q and A session. Last year, the Q4 was a great quarter, but even so, I think that the start of this year has been exceptionally positive. Next slide. We've had some very great key achievements, and I have the key highlights on this slide.
Yesterday, we signed the collaboration with MSRB and Otsuka, which funds the 7 funding projects through clinical proof of concept. And that means that now we have this particular project fully financed through proof of concept. Earlier this year, we had a successful end of Phase 2 meeting with the FDA for Mersdopetan, and that means that we now have the Phase 3 study program confirmed. We've had and generated new insights from the Phase IIb study with pericamat, and that has led to regulatory approvals to reduce sample size with retained statistical power to detect treatment effect. And the 4th, we've just had the regulatory approval to start Phase 1 with 757.
And we anticipate that the study will start during this month. Next, please. So going from this high level highlights to some more details. Starting with 757 that is now fully financed through proof of concept. We will run the initial phase 1 study based on the grant that we received from the Michael J.
Fox Foundation And then the MSRB, agreement will fund all the rest up to and including a clinical proof of concept. For the initial phase 1 study, we have the CERO contracted and we have now the regulatory approval and we anticipate that this study will start before end of the month. Next, please. So, the development collaboration with MSR D Otsuka, what is it about? Well, the scope that is really to take 757 through clinical proof of concept and this in 2 populations.
It is both in Parkinson and Alzheimer's disease, 2 populations where apathy is very frequent and, a very large unmet medical need. And we have now secured the financing to do all this. Next. So what will the different parties do? On EareLab, we will receive upfront payment and activity based milestone payments.
We will execute the development activities. We will also retain the full ownership of the product and all the IP. And on next slide, next. And on the MSRB side, they will, in addition to paying the upfront, milestone payments, they will fund all the development activities under the terms of the contract. MSRD may extend the collaboration beyond proof of concept, but that is subject to new negotiations and new deals.
And, and in the event that MSRD would not extend the, the collaboration, well, then they will receive single low single digit royalty on future sales. Next. So what does this mean for YearLab? It is very important, and there are very multiple positive aspects of this. The first one is, of course, that this brings near term cash flow to us upfront in milestones, 8,500,000 US dollars, 3,000,000 US dollars upfront and the rest in activity based milestones.
It secures the full financing of the development activities, as I said, in 2 populations with apathy, Parkinson's and Alzheimer's disease. And this also gives us the opportunity that when we have generated these active these data, I would really stress this clinical data, that's when we can then go out and seek licensing for commercialization of the product. And of course, it could be Otsuka, or I should say MSRB Otsuka, but it could also be another party. But the value of the project is of course much larger when we've generated the clinical data. This also provides additional external validation of the R and D innovativity as well as the quality.
It is also a validation of our, partnering and business development activities. With this signed deal, our assessment is that this deal provides condition to run the business without additional capital injection, past a potential licensing deal with Mestopton and past the top line data in the Phase 2b study with pyramid. We have not communicated the total value of this deal. But just to give you a benchmark, the industry average, you estimate the cost to take a compound from phase 1 initiation up to proof of concept to be in the, in the range of about $25,000,000 Next, please. If we then continue with Mesopotam, we're continuing driving this forward.
In our lead indication, levodopa induced dyskinesia. We had a successful end of phase 2 meeting with the FDA. So we have now an alignment on phase 3 program. And also importantly, we have an alignment on the path forward to NDA filing for market approval. Parallel to all these regulatory activities, we have continued with very high intensity of business development activities.
In the second indication for mestopetan, the psychosis in Parkinson's disease, we have made progress. We have a scientific article in neurotherapeutics reporting the antipsychotic effect of mastopetone in a preclinical model. And this, of course, further validation of mestopetone as a product. I should, though, state that, of course, our key focus now that is to drive the initial indication levodopa induced dyskinesia. But it's very good to know that there are also other opportunities when you have taken the first indication all the way through.
Next, please. Here at MAD, I call this a regulatory update because it has had some regulatory implications. As you know, we are running the REACT PD, our dose finding study, Phase 2b study in patients with Partizan and treatment 4. And the aim is to reduce the risk of fall. We have done blinded analysis of the data, and that shows that we, following initiation of all recruiting centers, we have a very stabilized patient recruitment rate.
We've also observed high and stable fall rates at baseline, actually more than what we anticipated, And this has implications. Next, please. The implications is that we have a high probability to detect treatment effects even with a lower sample size. And we have now reassessed the sample size, that has been approved by the regulatory authorities so that we can run the study with a lower sample size. Secondly, by using now the data driven estimates, we can get much more accurate study timelines.
And based on that, we see that we anticipate completion of patient recruitment during the Q3 this year. Next, we have also our 2 preclinical projects. And here we continue with, CMC work to develop the IP, API. And we are, as you see here, estimating these projects to be ready for Phase 1 end of the year or early next year because we need to find time slots for toxicology studies in the CROs. Next, please.
During this period, we've also had participation with given presentations at scientific meetings and financial conferences. We attended the, ADPD meeting in Lisbon, where we presented, 2 posters, one describing the REACT PD, the CurepMed study in detail. And the second poster that was to give the preclinical in vivo characterization of 11/17. And this is the first time that we have revealed, data on this, compound. We also participated in the BIAS LUN meeting, where we presented different statistical methodologies to improve study, designs, and also how to use statistical methods to monitor studies as they are ongoing.
At financial conferences, we presented here in Gothenburg at the Life Science Day. We took part in the in a fireside chat with ABG. And we participated in, Redeye Investor Forum. So all in all, a period with lots of very important, progress, which we are, of course, very pleased to see. Now, I think it's time to leave over to Nikolas to take us through an R and D update.
Please, Nikolas.
Thank you, Gunnar. I will try to follow on that smashing news flow that you actually give. Can we have the next slide, please? And I will just continue with stressing some of the very important and quite substantial developments that we've had during the Q1 this year. I'm going to talk about this, but I would like to continue discussing the clear path to NDA that we have chiseled out together with the FDA.
And that's a really important milestone. Further regulatory validation has been provided also through the approvals of the refinement of the study protocol for Pirapimat. Gunnar discussed a little bit around the aspects of why we did this. But the important thing here is that we have been given the nod from all of the regulatory bodies around Europe that actually has seen the strategy that we want to put forward. That means that we can now reduce the size of the study with about 25% with retained statistical power.
And that's really, really important. And also, as Gunnar mentioned, we have learned a lot about these patients and their condition of life during the progression of the study. And then last but by no means least in this list of regulatory successes, we have now gotten approval for our 3rd program to enter into clinical trials. And I think this causes a little pause here because preclinical programs in a small company in Sweden is quite unique. And remember that these are drugs that where we have, developed the hypothesis, we have developed or discovered the molecules themselves.
We have created the description, the pharmacological description of the programs. We've taken them through IND enabling studies and got into Phase IV approvals for Phase 1 for all of these. And of course, we are in Phase 3 with Mesta Boudin Phase 2b with durumab. So at this stage with Irlab, we have 0 attrition. And that's quite remarkable.
And so we go on. This is a slide we've shown a number of times where we look at the symptomatology of Parkinson where we have looked at different parts of the symptomatology and found openings for novel treatments. Next. Mastopetum covering dyskinesia but potentially also psychosis
where we
are building a case. Next, We're looking at the falls, the balance problems, but even swallowing as a potential improvement here. Next, please. And now also IRL 757 addressing the very important aspect or a very complicating aspect of neurological disorder and that's apathy. And there are no treatments out there for apathy today.
We're covering that as well. Next, please. Now the next challenge for us is now to bring 942. And next slide, please. Next click there and 1117 also into clinical trials.
And we are moving along those paths. Next, please. A few words on mestopetone next. This is a 1st in class molecule with a novel mechanism. And from a patient, a treating physician and from a marketing potential, novel mechanisms are really important.
This is a drug which inhibits dopamine D3 receptors, and that leads to a reduction of the involuntary movements induced by levodopa. We have a very strong patent portfolio around this asset, stretching potentially stretching exclusivity based on pattern into the 40s. Next, please. Going back to the same topic again, but I think that it's important to stress this that we have confirmed alignment between the agency, the FDA and HeteroLab on the, how the, phase 3 program, is gonna be designed. And this goes both to the efficacy trials, but also to the study that is determining the safety of the study, where we have a 1 year safety follow-up for the patients entering into this trial.
And also a number of additional aspects relating to CMC, etcetera. We are in alignment with all these, aspects of the programme. So the roadmap to NDA is clear to us. In the wake of the discussions with the FDA, we have also now initiated a process to get into discussions with the European regulatory agencies before we press the button, the start button for the Phase 3, to see if they have any additional requirements that they want to see for a drug treating dyskinesia. And we should all remember that there is no approved drug for dyskinesia in Europe yet.
So in Europe, this program is the most advanced that we know of. And then we have the possibility actually to start this trial the trial program later on this year or at the very end of the year. That's a clear possibility. Next, please. I wanted to show you this.
This is, of course, very deep scientific data, but it illustrates the potential for Apotam as an antipsychotic. And if one just looks at the graphs there that are introduced into the slide At the very, well, from my perspective, left side, you see a red band, of aberrant signaling captured from the brain. This is electrophysiological captures. And then there is a treatment. The next panel antipsychotic impeded, as clozapine, which reduces that aberration.
And then you see the effect of 2 doses of mestopetam following that, which basically takes away the aberrant, signalling but also restores what is so necessary. And that is complexity in the signaling between brain regions. And this is a very good example of a very advanced way of studying psychosis in the model of Parkinson's where messed up with ARM excels in terms of efficacy. Next, please. And this was published recently, I should say.
Paper Mart. Next, please. Going back to the false indication again. And this is one of the biggest problems in Parkinson disease, the falling. It's introduced at the mid to late stages in most patients.
About half of all patients fall recurrently. The life limiting, the quality of life limiting aspects of falling is not fully appreciated. There's lots of literature describing the complications, but also the cost of the falls. And for a fall that enters into a hospital in the U. S, the cost estimate around $30,000 and that was a couple of years back.
So it's probably much higher today. If one can reduce the risk of falling just a tiny bit, 25% to 50%, then that would be a very significant improvement. We have an ongoing study, as most of you know, across Europe. We expect to finalize recruitment in this trial during Q3. That's our prediction right now.
And that's based on our discussions with the regulatory authorities, which we've been into before this presentation. Next, please. Piriformat, just like Mesto of a product. To have a new class is, of course, a huge advantage. This is a drug which acts through inhibition of at least 2 targets in the brain, ILFA2 receptors and 587 receptors.
And also here we have built a very strong patent portfolio or a state around it, stretching exclusivity potentially into the 40s as well. Next, please. Updates in Q1. And Gunnar discussed this a little bit, but we have looked at blinded baseline data to understand better how these patients behave. We have higher fall rates.
We see stable baseline. That's interesting that the patients tend to fall on a steady pace during at least 1 month the run-in period of our study. And, we saw that withdrawal rates were slightly lower than we anticipated, which all these things together means that we can actually reduce the sample size. So we've discussed that with the authorities. We also discussed how to handle this type of data statistically.
It's not trivial, I should mention. It's not trivial at all. And they have accepted our way of looking at the data. And that's really, really important. Next.
757, we talked a lot about that today. So we go to next slide. Apathy as such is a huge problem in neurological disorders. You can see a panel here with different frequencies. But about 20% to 70% of all patients with Parkinson or Alzheimer actually experienced apathy.
And this is a condition that not only affects the patient, but also the surroundings in terms of the caregivers. There are a lot of hypothesis or some hypotheses around the origins of this, and we have focused on one of them and that is the connectivity between cortical areas and lower brain areas. 757 has a unique profile in this respect, restoring connectivity between cortical and subcortical regions, which could be a way to treat apathy. Next. So the main progress in this period has been the, of course, the completion of the preclinical package, the IND enabling studies.
We have received the funding from Michael J. Fox Foundation. We are now initiating the Phase 1 programme together with the CRO in Uppsala, our colleagues at CTC. And we are now also since yesterday in a collaboration with MSR De Otsuka, which actually is really, really important. This supports the program all the way through proof of concept, not only in Parkinson, which is our main goal, but also in Alzheimer's disease.
So we'll get readouts from at least 2 indications through this collaboration. And the collaboration will be a true collaboration where we are working together with developing the product. We're developing the protocols for the studies together, and we will execute the studies. And we will be the sponsor for these studies. But, of course, MSRD and ZUKA will have an important role in the program.
Just as MGAFF has a very important role in the Phase 1 SAD MAD studies that we're conducting now. Next. The preclinical programs. Since we now have moved 757 into clinical phase, We have 2 preclinical programs, 942 and 1117. Next, please.
942 is focused on cognitive dysfunction and neurological disorders. This is a huge market. There are still unmet needs in this space. The current treatments, they work, but they could work better. And we think that 942 is that solution.
11/17 is a totally new strategy to treat Parkinson's symptoms, the hallmark symptoms of Parkinson's. Also a huge population around 6,000,000 people around the world could be addressed. Next. So if one looks at some statistics on the occurrence of cognitive dysfunction, 12% in all people actually over 65, experienced cognitive decline. And this is, of course, much, much higher in neurodegenerative disorders such as Alzheimer's and Parkinson's disease.
Today, there are a couple of possibilities to treat this condition, but we think there is room for better and novel treatments working through different mechanisms or new mechanisms. Next, please. Progress in this program has been ongoing. We are developing the synthesis of the API necessary for the tox studies. We are developing a drug product for coming Phase 1 studies right now.
And we expect to be able to start if we get the time slot at the CRO, Phase 1 study or talk studies, 1 month talk studies during this year, which means that we are could be Phase 1 ready at the end of the year or early next year. Next, please. Going over to 11.17, which is the last in the presentation, but by no means the least. This is a really, really interesting program, at least from our perspective, who have been involved in PD research for so many years, where we now have discovered a way to actually activate motor function over long periods of time without complications. So this is also, has the potential to be the 1st drug in a new class, which could actually compete with levodopa as a mainstay treatment for potentially compete with levodopa as a mainstay treatment for Parkinson's.
Next, please. We are right now building a very comprehensive preclinical efficacy, tolerability and BMPK package before we go into doc studies. And what we've seen so far is that we have, after single doses, long exposure of drug, but also long effect of drug over 24 hours after one single dose, improving multifunction. This without giving any of the complications, step 1, see in parallel groups treated with levodopa. And in animals already treated with levodopa, if you switch to 11/17, the complications goes away and you still retain the multifunctional activation.
So this is gonna be a really, really comprehensive package. We are right now working on the development of the API, the synthesis of the product and IPR, of course, filed a couple of years back and stretches into the '40s with exclusivity. Next, please. And this is now Victor's arena. I will hand over to Victor.
Thank you, Nicolas. Finance report. You can go to the next slide, please. This is a picture Gunnar showed earlier, and it shows the financial implications of the agreement with, MSRD where we will get $3,000,000 in an upfront payment and then another $5,500,000 in different milestones. And next slide, please.
So this is a slide that I've shown a few times before. And the line in the graph shows the likelihood of a compound to go all the way to the market. And as such, it also represents the value of a project, of course, since, as the risk becomes smaller and smaller for the compound. And we can all see that the big action is in phase 2. So if you get through phase 2, that is where you actually build value and you decrease the risk in the compounds.
So we marked our compounds here and we can see that mastopetamin is basically through Phase 2 And pyridmat is getting closer to the end of phase 2 there. So for 757, you can see that it's just going into phase 1 now as we got the approval from the agencies earlier this week. And then we need the funds to take it through these these steps. And with the MJFF grant, we will take it through the Phase 1 clinical studies. So that will take us quite a bit into Phase 1, or basically through Phase 1 when it comes to the clinical studies.
And then we have all the other activities that needs to be done parallel to that. And that's where the MSRD comes in because they will do everything that's needed to take it further along, including a signal finding study. So that is taking it, a bit into Phase 2. And you should all remember that this is with funding from MJFF and MSRD. So from now on, AmerLab does not have to spend money on external cost on 757.
We will have internal cost. Our employees will work with the projects and so on. But the external cost is all covered by MJFF and MSRD. And as you can see, 757, if everything goes as we hope, we will create a lot of value in 757 under this during this time. So, I think this picture quite clearly depicts how important the MSRD decision, the collaboration with MSRD and the grant from MJFF is for 757 and also for IRELAB and our shareholders.
Next slide, please. This is the normal picture that we usually show. We can see that the costs have gone up a little bit and that is mainly due to increased costs as planned in the PIRIPMOD study, showing that that study goes on in a good way. And also, we have had some cost finalized 757 to be able to take it into Phase 1, which we start now in May. And we're also doing some extra work on Mesto Potom to be able to make it as good as possible in the discussions we have with potential partners that we're having at the moment.
I would say that we are still cost conscious. The headcount has increased with 1 person, and that is a person that works a lot with the clinical studies. So, that is absolutely needed competence that will help us a lot in the future. Next slide, please. Well, a financial summary for all of those who like to read it.
And the next slide. These are our analysts that will be involved in the Q and A. But, Guler, maybe some concluding remarks.
Thank you, Victor. A couple of concluding remarks. As you have seen here, next slide, we have, through our own discovery and our own development created this portfolio of projects. And here is the updated slide for the portfolio. We won't go into all the details here, but I want to stress once again.
We are a small company. We have now 3 projects in clinical phase and then 2 preclinical projects on their way to get phase 1 ready. Next slide. I come back to my initial slide and that is to just once again summarize the key highlights, because these are extremely important events that we have brought through during this period. It is the collaboration agreement with Empress RD Utsuka.
And as I stated, and has been done by Nicolas and Victor, We now have the fully financing to take this through proof of concept in 2 different populations. And having the full ownership of the compound, we are getting into good position when we are through this collaboration, and we are talking talking about licensing for commercial session. And of course, it could be a continuation and extension of a collaboration with MSRD, Utsuka, but it could also be with others. But the key thing here that is that we are getting in a much better position when we initiate such discussions after having generated clinical data. We went through the end of Phase 2 meeting with the FDA.
We have the Phase 3 program confirmed and we have confirmed the path through to INDA filing for market approval. For Piracomat, the new insights of this population and what we've seen in the ongoing study resulted in regulatory agreement to reduce sample size, but still retain the statistical power to detect the treatment effect. And the last bullet here, we have now our 3rd compound being approved to get into clinical testing. And with everything prepared, we anticipate the start already this, month. Next.
Before we end, I just wanted to say something about our development, business development activities as well. We are at present in very intensive activities here. We are becoming aware that the lab is now recognized and people recognize the development pipeline that we have, and that is very good news. We are continuously and frequently interacting with potential partners. We are, having questions and discussions on partnering opportunities across the portfolio.
But of course, now when we finalized the deal with MSRD Utuka, our key near term focus that is on mestopetan. Next, please. So Eelaven, a world leading portfolio in Parkinson. We have, as you know, pioneering biology and a unique ISP platform to discover novel molecules. We have a focused strategy.
We have validated our business model. We generate new CDs. We take the CDs into development up to Phase 3 Readiness and we have the experience of multiple deals. Broad and in Parkinson world leading portfolio. And we are an organization positioned and committed for success.
I think it's now time to move over to the Q and A session. So please, Victor and Niklas, hand over to our analysts.
Thank you so much, Gunnar, Niklas and Victor. I will shortly hand over to Sue Ramanoff of Edison Group. Please, Sue, go ahead with your questions.
Thank you for taking my questions. Congratulations on the MSR D collaborations for IRL 757 apathy. I'm going to pile on with a 3 part clarifying question. Do you expect MSRD to be actively involved in the clinical development or will they be more passive? 2nd, can you provide more color on the overall dynamics since we have Michael G.
Fox Foundation? And then also on the guided timelines? And then the last piece is, I think they were also evaluating IRL 9 42 for cognitive function. Is that still the case?
If I start with the first part, and that is how will they be involved? We will now have a joint steering committee. And in the joint steering committee, all the plans will of course be discussed with full engagement from both sides. Then when we have agreed, this is what we're going to do, then Igloo will do the execution of, the activity. Do you want to to ask the next question?
But given the vast experience of MSRDx OXOCCA teams in development in these indications, of course, their teams there will support the programs actively during the progression of 757.
Yeah. The second question that was how do we see the MGFF and MSRD come together? I can state to you that we have full transparency between the 3 of us of how things hang together. We do not foresee any complications in this trio that will move forward. In the initial study, we have the closest collaboration with the MGFF since they are funding the activity.
When we then move over to the next couple of activities that are funded by MSRD, of course, then it will be mainly through the MSRD, Eelab Joint Steering Committee.
So to use an IT term, this is plug and play. We have first our collaboration of MFF and then on and on and building on that with the bid further with MSRD, ZUKA.
So we do not foresee any specific hiccups in the time schedule. We have now a clear path forward, and that is the one that we will follow. Then your last question, and that was about 942. You're absolutely right. We communicated a year back that UTSU sorry, MSRD had a had the possibility under exclusivity to review both 942 and 757.
As we have been discussing and things have progressed in this evaluation period, MSRD came to the conclusion that they wanted to focus on 757. So, this collaboration is only about 757.
So for the, my second question, I agree with you that IRL 1117 is really exciting and is, it's probably really important longer term. Can you give us an overview of your preclinical, what we should expect as far as milestones and the preclinical study activity? Yeah.
I mean, we we as I go today, we have a very comprehensive package of efficacy data now and long term efficacy data over months actually in animal studies. With that at hand, the next step now is to finalize the CMC activities to be able to start the, tox studies, the 1 month tox studies. And when that is done, we are ready for, phase 1 basically. So talks and safety is the next step. And we will, of course, keep everybody posted on the progress there as well.
And just one I'll squeeze one last one in since it's pretty timely. The I think one of your peers reported some positive news target dyskinesia. And I was wondering if there you saw any like key learnings or read across to the mechanism of action or enlightened
I would assume you're referring to tavapadon, the 5 agonist or partial agonist. Yeah. And our assessment of the data and the inclusion criteria in those studies is that they are not focusing on, and the endpoint structure in the studies. They're not looking at dyskinesia as such. They're looking at tervodone in a mid stage population with very little dyskinesia.
They're looking at add on to levodopa to improve good on time during the day. And the data that they've shown so far indicate that it's equivalent to what you see with COMT inhibitors and MAO inhibitors. And no efficacy on dyskinesia. The necessary step to show anti dyskinetic effect is to include the unified dyskinesia rating scale in a trial. And there was no such scales in that trial specifically.
So important that they have actually found a drug which can actually prolong the effect of levodopa or support the patients with in their levodopa treatment. But so far, they do not compete with, this data does not compete with, mestopetone.
Great. Thank you.
Marc, Sue Romanov at Edison Group. And it's time to move over to Redeye and Equity Analyst, Frederic Thore. Please go ahead with your questions.
Yes. Hello and thank you. So this is a follow-up question to Sue's previous questions about the MSRD and regarding the IL-seven fifty seven drill. Why are, I mean, both Mytolia Focus Foundation and MSRD interested in 757 and apathy, What is the, yeah, why the big interest, Visko?
Of course, you should probably ask them to get the proper answer, but my interpretation of the situation is that apathy in neurological disease is a very large problem. Today, there is no treatment for it. And, I think that they have seen the potential in our molecule that this could be really a breakthrough in this area. But that's our interpretation. I don't know if you want to Yeah.
I mean, we share that view. I mean, we think we have a potential for a breakthrough. This is a novel mechanism, a totally novel pharmacology to actually address apathy, which has been tested over years with different types of psychostimulants and other types of antidepressants. That doesn't work very well, has complications. And here we have kind of found a new way to address apathy.
And I think they have acknowledged that, both MAF and MSRD. They acknowledge this and want to be on the bandwagon together with us.
Interesting. And when it comes to later stages, for example, phase 2, bill or something like that, how how long would you need to how long would the duration have to be to see a clinical effect in, for example, this IC scales that you would use?
In this type of condition, about between 3 6 months is necessary to show an effect. It's to some extent similar to efficacy trials in motor function disorders, 3 to 6 months, but also to capture effect with let's hope there is a growing effect over time, then you also see that 3 months is the minimum.
And maybe a final question about this deal structure. I mean, you get funding and some cash, but retain the rights, which is not maybe super common in a Swedish context. Could you maybe from MSRD's perspective, can you maybe explain why they would want this structure of ODDO?
Of course, this is a way for them to, as Nicolas expressed it, get on the bandwagon with something that's very new and that could really be a breakthrough. They do it through this construction of the deal so that they will be fully aware of the data as they come in. And of course, that means that they have, someone said, a pole position when it comes to future licensing of the drug for commercialization.
Interesting. Yes, that's all for me. Thank you.
Thank you so much, Fredrik Tore of Redeye. And we're moving over to Alexander Kremer at ABG Sundal Collier. Please go ahead with your questions.
Yes. Good morning. And first of all, one question regarding the financial runway. I mean, in the report today and also now today in the presentation, you mentioned that your financial runway will last past a potential messed up at partnership deal and the React PD readout. So considering all this and considering also the 2nd tranche of the formula loan that you can still take now during the summer.
Can we expect that your financial runway lasts into 2025?
Yes. Thank you. What we've said is that we've now with this deal has the potential to stretch the runway that far. As you said, we have a potential to increase the loan with Fermi Nord to take another $25,000,000 under certain sorry, under certain circumstances. And also as we have the milestone package, we see that if those clicks in, then we will be able to stretch the runway quite substantially into 2025.
Okay. And I mean, talking about milestones, like when do you expect to receive milestones from MSRD at which specific
That is not disclosed and will not be disclosed until that happens. Absolutely.
Because
we have been important.
And then one last question regarding the sale. I mean, we today, we already talked a lot about IRS 757. And like when you talk to MSRD about the efficacy signal finding study that you're planning to give now, What kind of apathy endpoints are you looking at? And like what is kind of the focus of MSRD? Like what kind of efficacy to prove?
That is something that we are unable to share in terms of what and how much and statistics, etcetera. But you can be assured that we will use the most common scales that are used for measuring or assessing apathy. We are also discussing to include a number of biomarkers, in such study as well to support the readout and understanding of the effect, of 757. And if I can just fill in one thing, and I think it's really, really nice for us to be able to start talking about 757 now. We have they've been in the in the background 757, 942, 1117 for a while.
We've always talked about Peter Martin and the Mesta Upotam, but now we have a 3rd player in the game to talk about and which has a huge potential. We should all remember that, a huge potential. We are addressing a huge unmet medical need.
Thank you. That's it from my side.
Thank you, Alexander Kramer at ABG Sundal Collier. And I have one last question regarding the development collaboration for IRL 757 with Otsuka. Will this put them in the poll position for discussions regarding later stages?
Could you repeat that?
Yes, well, yes, I can answer. Yes, absolutely. And I think that's the whole point for this deal from their perspective, to actually have a foot in the programme when the licensing discussions get into play. Licensing and commercialization discussions.
That's what I meant when I said have the full position when discussion on licensing for conversation would start.
Okay. Thank you so much. And that was all the questions for you today. Thank you so much for the presentation, and good luck going forward.
Thank you very much.
And thanks for watching.