Welcome to this live broadcasted Q1 presentation by research company EirLab Therapeutics. Presenting today is CEO, Kristina Torfgaard Executive Vice President, Research and Development, Niklas Waters and CFO, Viktor Sievertz. After the presentation, there will be a Q and A session with equity analysts and viewers can ask their questions in the live chat. Hello and welcome Kristina Torfkord.
Hello and thank you very much.
So please go ahead with your presentation and I'll be back for the Q and A.
Sure. Thanks. So first of all, on behalf of Eilab, I would like to welcome everyone to today's webcast where we are going to present the Q1 report. And if we start with the slides, please. And the next one is our disclaimers, and then we have the agenda, next one.
So I will start and take you through the news of the period. After that, I will hand over to Nicolas Waters to take you through the R and D update. And this will be followed by a financial update by Viktor Silvec. And I will then make concluding words, and then we will start off the Q and A session. So the next slide, please.
I would like to remind everyone and start with this slide. And this is really the basis here for our research. Parkinson's disease is a severe and devastating disease, the second largest of the neuro neurological diseases. And as you can see here on this slide, we can see that there are a number of different symptoms and complications that those individuals that are living with Parkinson's experience. What we have is that we have five, first in class candidates.
And if we move on to another click there, we have five candidates where they all have a unique, can you click one more? Yes. Thanks. So we have five candidates in development, where we have, all are first in class with a unique mechanism of action. Three of them are in development in clinical stage, and two of them are in preclinical stage.
And as you can see, they are all targeting all the different symptoms experienced by people living with Parkinson's disease. So if we move on to the next slide. We have had a very, very intense and dynamic first quarter of the year where we have a number of progress, especially in the regulatory field, in the clinical field. As the first one, would like to highlight here is the positive feedback that we received early on in February from EMA. The feedback on the Mestapitan program, what was covered both the preclinical, the clinical, and also the program for phase three.
This will strengthen the potential of the candidate and also the value of mastabatan. We have had positive results in the phase one studies that we have performed on seven fifty seven. And we have also made the decision together with MSRD Otsuka to initiate a study in patients with Parkinson's disease and apathy. So this is according to to the timeline that we had, and progress are moving forward. And I would also like to point out that this program is fully funded by MSR Jaussuche.
So finally, we had also the Peripramat readout, in the top line data, that we presented. And here we have can see that there is a significant clinical meaningful reduction in fall frequency. And this guide us both for the future designs of the clinical studies, but also we are also looking into the next steps. So I would like to go more in-depth in the, highlights. So if we click on the next one.
So for the more important events here for Mesopotam, as I already mentioned, we had, the EMA feedback, but this time we also received feedback on the pediatric program. And what we did was that we submitted, arguments, that was accepted that there is no need to perform studies in children. And this will allow us now to focus only on in studies in adult patients, which is great. And this is in line with the feedback we received earlier from the FDA. We have also received, as I pointed out, positive feedback on the Phase three program.
And this is really also in line with the FDA feedback that we received about a year ago on the Phase three program. In addition to these preclinical and regulatory, activities, we have also published an interesting article in the well known, medical journal, European Journal of Neuroscience. So this is an article where the more of the mechanism behind, Mesdopitant is described. And here we can also see that Mesdopitant clearly differentiate versus other, candidates, already on the market or in development for dyskinesia. And we can also see that we have a potential to move further on and broaden, the indication to psychosis.
So the next slide, please. For piripipamat, early on in January, the last patient went through the study, and we were able then to present the top line results in March. The first presentation, we were very proud to show that we had an effect on the fall rate. However, this was not significant, different versus placebo. Later on then, we did additional analysis, in-depth analysis, and there we could clearly show that we had a significant and clinical meaningful change also on the fall frequency for pipramat.
And Nicolas will take you through more the details, of course. For 07/07/1957, we had positive results, top results in the phase one study in elderly. And these data results together with the study previously concluded in healthy volunteers in younger subjects were able us to support to continue with the seven fifty seven. And we also made the decision to initiate a study in patients with Parkinson's disease and apathy that will be starting later this year. So the next slide, please.
We have also had the opportunity to present the company for investors. So we presented the company strategy and the pipeline. First, at the Insight Direct, Dagen, in January, we had participated at Redeye Investor Forum twice and also Axis Barna Redeye theme quite recently in April. And you will able to find the presentations on the web and also on our web page. So next slide, please.
So by that, I would like to hand over to Niklas to take you through the R and D update.
Thank you, Kristina, and good morning, every listener. We'll go through the R and D by clicking to the next slide, please. So we start with Mestaputam. And as Kristina alluded to, we've had a quite busy period with Mestaputam from a regulatory standpoint. Next, please.
This is a first in class compound with the properties of inhibiting dopamine D3 receptors, which are implicated in the genesis of dyskinesia. We have, as a side order, we worked quite hard on the IPR estate around Maestrovita in the past few years, and we have the portfolio during the period, the patent portfolio. And we can now see that we can have exclusivity into the well into the 2040s with the patent state we have generated so far. The lead indication, of course, is levodopa induced dyskinesias. We've talked a lot about that over the past years.
In addition to levodopa induced dyskinesias, mastopoderma has potential to treat other types of complications in Parkinson's disease and also in other disorders. And we have generated over the past year and published data supporting the use of, Mestopetam in Parkinson's disease induced psychosis. So this could become the first drug in history which is both antidyskinetic and antipsychotic, without compromising motor function. We also have data supporting generated data supporting prevention of or the occurrence of levodopa induced dyskinesias. These are preclinical studies, of course.
Another aspect of in the use of, and data we've generated concerning, Mr. Butami is that it should be possible to optimize the dose of levodopa to support patients' basic functioning without inducing dyskinesia by pretreating with, mastopotam. And then we also have built a case around, tardive dyskinesia, which is also driven by D3 receptors. Next, please. Going back to the regulatory work that we have done during the past period.
Last year, we received feedback from the FDA on our plans and on the portfolio we've generated on, Mesta Obuton. This year, we also had the opportunity to talk to Ilma and get some scientific advice from them concerning our plans and concerning the data we've generated. And, the take home message that we have collected is that the, agencies both in The US and Europe are, in agreement with how we should conduct a phase three program for masturbotan. So we have adapted, the plans for these studies, accordingly. In addition, we've done market research and looking at what health providers across the globe want to see with the with the new treatment in, treating, dyskinesia.
And that is really, important feedback also to adapt parts of the phase three program to also include information from payers, what they want to see, basically. And the key components that we have come up with, in the phase three program is that we will do two parallel phase three studies that will comprise around two seventy patients in total. That's 30 patients per study. We will also give the patients who enter into the double blind treatment arms, where they will also be offered an open label extension after the three month period of treatment has ended, which means that they would be treated for as long as twelve months with a masturbiton. And this is to build the safety database.
We also have agreement across the globe. All agencies agrees that we should use the unified dyskinesia rating scale as the, primary endpoint in the study, and we should use the sum of parts one, three, and four, and we should exclude section two of the unified dyskinesia rating scale, which deals with dystonia, not dyskinesia per se. The dose, that we have chosen, have been, approved or accepted at seven point five milligrams twice daily. And this was the dose that had the best effect in the Phase 2b study, came in significant on the Unified Dyskinesia Rating Scale. Clinically meaningful changes, that we saw, were significant, combining sections one, three, and four.
And in parallel with the, efficacy studies, we will also initiate a separate safety study, and that is to make sure that we get the three to six hundred patients exposed at patients exposed to masturbotan, which is needed for approval and for the safety database. Next, please. Talking to the, talking about the positioning of Maestro Potom, and this is something we've been doing with experts, key opinion leaders. We've also talked to payers and health health, providers across the globe looking at the positioning. And during the course of, the progression of Parkinson's disease, patients start with levodopa treatment after diagnosis.
And as the disease progresses, one adds additional, add on treatments such as MAO inhibitors, COMT inhibitors, but also amantadine in certain regions to manage the complications that are, occurring over the course of the development of the disorder. In the late stages of the of the disorder today, there is a number of invasive strategies to actually manage motor function better than with the oral treatments. And that is, infusion therapies based on, continuous infusion of levodopa or produdopa, and there is also electric stimulation or DBS, brain stimulation, inserting electrodes in certain brain areas to control motor function. And the positioning of mastoepatong is in between the when the traditional management of motor complications related to levodopa is no longer working, mastopotam fills the gap between that stage and the invasive stages. It also means that, mastopotam has the potential to actually delay the introduction of, or could delay the introduction of the invasive, treatments.
This is a very important part of the treatment algorithm where there is no treatment today. Next, please. Piripmat. Next next again. This is also a first in class compound, acts on alpha two receptors and five h five h seven receptors.
Also here, we have built on the patent, portfolio. We have exclusivity well into the forties with this asset. And the objective here, the primary objective of this program is to reduce falls in Parkinson's disease, which is the biggest problem. Next, please. This is a huge complication.
Almost half of all Parkinson patients fall recurrently or, every year, and up to many times a month. And this is, of course, complicating their quality of life, or makes it live much more difficult to to live a normal life. An interesting fact is that, in The US in 2020, the the spending for handling costs related to, falling in the elderly population, not only Parkinson, is around $80,000,000,000, which is a quite, quite large sum of money. So there is a huge market. There is big, there is big incentives for health providers to actually introduce help to introduce something that reduces the fall rates and, thereby the cost, of course.
Next, please. We presented the top line results recently, for this trial, the phase two b trial with, masto, piripimod. We could see that we had a general reduction in the fall rate in the study. We had a quite a quite substantial reduction of fall rates, at the six hundred milligram dose in this study up to forty percent percent forty two percent. We could also see that but it was not significant versus placebo.
We also saw movements in the cognitive scales, which also were in favor of treatment but did not reach statistical significance. Gladly, we could see that the adverse event profile was consistent with previously reported clinical trials, that we've conducted, and the, adverse event frequent, incidence was similar in placebo and in the treatment arms. Next, please. In-depth analysis, which we talked about a couple of weeks ago and Kristina mentioned also here in the introduction, we have also looked at the relationship between plasma concentrations and the effect. And in that work, we discovered that there is a very specific band of concentrations or plasma concentration levels that that leads to a reduction of falls in these patients.
And this is an important discovery, which means that we will be able we have the potential to actually titrate patients to the right plasma concentration and thereby, get the significant effect that we want in future, planned or future, potential studies. And this was a prespecified assessment that was mentioned in the SAP, of course, in the analysis plan. And this will be part of the the full report and the publications that we are working on right now. Next, please. So in in summary, we we actually achieved the goals that we had set out with the Pirip Mont study.
That is to get information of the dose related effects and also the plasma concentration related effects of, peripamat. Four seven five seven, we have the collaboration with Fox Foundation and with MSRD. Next, please. This is a first in class treatment to treat apathy, in neurological disorders with a focus on Parkinson initially.
This is a complication that occurs in, roughly twenty to seventy percent of all patients with PD, and can be also higher in other indications. Next, please. So the progress during the past quarter has been quite significant, in this program. First of all, we have completed the single ascending dose, phase of the phase one study. We have completed the multiple ascending dose phase of the phase one study, with results, giving us results that, indicates that this is a safe, tolerable, and, drug with very good exposure in in humans.
We've done an additional or completed an additional study in elderly, healthy, volunteers, 65 years and older, and that is to compare with, later on with Parkinson's patients as well. That was successfully completed. Together, these, make a very comprehensive phase one program. In parallel, we've also completed the toxicity studies that are necessary to move to the next phase to to run a study for three months. And we have just initiated or taken that decision together with our partner, MSRD, Otsuka, to initiate a clinical trial in patients with Parkinson's disease and apathy.
And this is a study that we will we will plan to start during the fall this year. Next, please. Going back to the preclinical programs. Next, please. We have two candidates here, 942, and 1117.
The 942 is the first in class compound aiming at treating cognitive dysfunction in in neurology with a focus on Parkinson's disease for us. Both of these assets are in preclinical development at present. Eleven seventeen is a novel totally novel strategy or and technology to treat the basic symptoms of, Parkinson disease, without any treatment related complications. Next, please. For nine forty two, we see quite large market opportunity here.
Most patients with neurological disorders enter into a phase in their life where they have dementia or cognitive decline. And the current treatments, they have their benefits, but also their complications. And we think that nine forty two could be a good add, add function into this, treatment algorithm. Next, please. During the past the past quarter, we have worked, on the further development of the preclinical, portfolio around describing the effects of nine forty two.
We've also worked on the GMP manufacturing of drug substance, which is a big task, together with developing a drug product that is the formulation of the drug substance. We have also made a decision to slow or reduce the development pace for nine four two during the rest of this year. So we we are now focusing on finalizing the CMC work and then postponing the toxin safety studies needed for phase one until next year. Next, please. 11/17, this is a familiar slide these days for most of you, but this is a program where we have selected eleven seventeen as the lead compound recently.
And this has the potential to be the first drug in a totally new class of treatment strategies for Parkinson's disease, the hallmark symptoms of Parkinson's disease. That is, it has the potential to replace levodopa should we be successful. The point with this drug is that it's a once daily treatment, which gives constant plasma concentrations over a twenty four hour cycle and also activates motor function over that twenty four hour cycle. And this is thought to lead to a better treatment without the complication, motor complications, such as intense fluctuations that patients experience. Currently, we are working on the development of the large scale production for for this product.
Next, please. So we've come quite far on the CMC development. It's still ongoing, but we've come quite far. In addition, we have built on the patent portfolio, and we're looking forward to initiate the IND enabling studies during the course of the next twelve months. Next, please.
So I'll hand over to Victor to give you some insights into our financial situation.
Thank you, Nicolas. So we can go to the next slide. We have in the end of the quarter about SEK 89,000,000 in cash. However, 58 of those are prepayments from MJFF and especially MSRD or Sukka intended to cover the cost for the seven fifty seven study that has been initiated. And just to expand a little bit on on that, these we got a quite substantial payment from them during the quarter.
This has not been recognized as an as a revenue as of yet, but rather as a prepaid revenue, so it's in the balance sheet for everyone interested in accounting. When costs occur in these studies, for example, if we get an invoice of 1,000,000 kroner, then these will, of course, appear in the p and l as a cost, but we will simultaneously recognize 1,000,000 kroner as a revenue, and thus reducing the prepaid revenues in the balance sheet. So even though we got the payment from MSRD or Utsukaal this quarter, there is not a corresponding revenue in the P and L. A little bit technical, but I hope some of you appreciate it. So if we continue to talk about the seven fifty seven, we can see the light gray bars in the middle table or panel in the bottom of the page.
We can see that the cost for that program has gone down a little bit, and that is, of course, due to the phase one studies that we have concluded or basically concluded. So the big costs for those were found in Q3, Q4. So since we have initiated the next study, we can anticipate that the cost will go up the coming quarters as that study will cost money, of course. We also internally have an increased focus on cost control. It shows a little bit on the darkest gray bar, where we can see that the cost has decreased a little bit.
The middle gray bar is the external clinical cost, which, to be more precise, is the cost for the Phase 2b study with pirapimod, where there is still cost. We expect those costs to be continue in Q2, maybe a little bit less than in q one. But then we shouldn't have much of those costs going forward. The headcount remains stable, about 30 employees. And we can take the next slide, please.
So net sales, 4,000,000. And as I mentioned, this is only the this is this is a corresponding cost for the $7.57 program that we've had. So we have an operating profit of of or loss, of course, of NOK 28,000,000, and we have cash of nearly 90,000,000. So then you can read the the other numbers yourselves, I guess. So with this, I will hand over to Christina to some concluding remarks. Thank you.
So next slide, please. So I would like us to go back to the pipeline here. And we have quite a broad pipeline. We believe that this is a world leading portfolio in developing programs for for Parkinson's disease. And as we can see here, we have five candidates, all first in class with unique mechanism.
So the first one, masturbiton. We have the opportunity to take this into two different symptoms, would say, both dyskinesia and psychosis. We are ready to start up a phase three program, and we are working very hard to get a potential partner in place here. For piripamat, we have just concluded and are evaluating evaluating the final results now in the trial, the Phase 2b study that we performed in false and impaired balance. We are looking into next steps here, and we'll come back on that.
But we can also see that we can broaden this into dementia as well. For July, in the collaboration with MSRD Utsuka, we have just started off an initiated preparation for the phase one b study in patients with apathy, to start the second half of twenty twenty five. For September, as we mentioned, we have decided, for the benefit of the other candidates to, to halt some activities here. And therefore, we are postponing for a start of phase one, into 2026. For 11/17 for Parkinson's disease, the broader treatment, we can see that we will initiate the IND enabling study allowing for going into the phase one during this year.
So next slide, please. As one of our as the business model really is that we have a business development work and we are partnering, I will ask us to spend a few minutes on this slide. So during this quarter, we are continuing to increase the awareness of the company, both in externally, I would say, to different potential partners, both small and big pharma. We have continuous dialogues with a number of potential partners and giving updates and have ongoing discussions there. So after we had the successful collaboration completed with seven fifty seven, where the highest priority and focus is now Mestapotam and Piripmat, but we are also evaluating across the portfolio also for the other candidates.
So the next slide. So I will end off here with take you through the upcoming milestones that we have during the upcoming twelve and eighteen months. And as you can see, this will also be a very intensive and exciting period for the company. For Mestapatan, we are continuing with the BD activities, and we believe still in initiating the Phase three program. Peripramat to complete the in-depth analysis that we have ongoing, defining the strategy forward here in the development program as well as the BD activities to continue there.
For seven fifty seven, the highest priority is to start up the study with Parkinson's patients in apathy. That is what we also call a signal finding study that will be crucial for us. And the preclinical activities continuing to prepare September and 11/17 to move in to start clinical studies in phase one. So by that, I think I will hand back to you Matthias, and we will start the Q and A session.
Thank you. Thank you so much, Kristina and team for this presentation of your results and activities. I will soon hand over to Kevin Suhle, who is Equity Analyst at Redeye to ask his questions. But first, let me address the audience and I want to remind you that you can write questions to our Lab Therapeutics in the live chat. And with that, please welcome Kevin Suhle, an analyst at Redeye. Please go ahead with your questions.
Hi, and thank you for taking my questions. Now as you mentioned, you have an increased focus on cost control and you, for example, decided to slow down the development pace of September in order to focus your resources on some more critical activities within the company. Now could you, to begin with, elaborate on how you decided what sort of candidates to prioritize at this stage?
So I can start for more general, and then we I can hand over to Nicolas as well. But to prioritize the mestopatan and pirapamat, the the two candidates that we have progressed longest with and that are closest to phase three initiation. That's very clear. And where we have very good partnering discussions, We need to have all focus there, both both, I would say, internal resources and also if additional studies need to be done. But for them, we have eleven seven seven fifty seven that we have a commitment and with working with MSR and Diotukiya.
So they are paying for the activities, and we have our internal resources that we include in this collaboration. So we have two prototypes as well, and this is very beneficial for us. And then we see that eleven seventeen, we have seen that there is a huge interest already for these early candidates. So we will also like like to bring this forward in a quite fast speed. Maybe you would like to comment if there is?
Not much. I think that was very, very well put. It's always difficult to make decisions, on what to bring forward. It's a it's a it's a sport in itself. But, of course, the clinical assets, late stage clinical assets are the most valuable ones.
Of course, we need to focus on those. With those does not come very much cost. So it's it's more dry work where we are working on, of course, discussions with the external work, but also compiling information, creating documentation around the pro programs. And that is what the team here is working on with those two. When it comes to web work, of course, seven fifty seven, as Kristina mentioned, is the most important program where we have a partner on board, where we have milestones ahead, and where we have clear objectives or milestones ahead.
And clear we have also have so good data in the phase one part of this development program that we we really have to move that forward as as quickly as possible. And and as I mentioned, we have a decision to actually start a trial this year, which means that we work very hard on creating the submission packages for the Phase one for the signal finding study or larger Phase 1b study in Parkinson patients. For the preclinical assets, it's hard to make your decisions there. But for eleven seventeen, it represents such a dramatic shift and an opportunity in the treatment algorithm for Parkinson's disease. That's that's our basic reason for, choosing to invest in that rather than nine four two at this stage.
They were head to head basically going into, IND enabling studies, but we've chosen to move eleven seventeen ahead before September.
Thank you. And you briefly brushed upon this in the presentation, but with your current main focus being on the late stage candidates and establishing partnerships for Nestle Petal and Peter Pimat. What is your current strategy for finding a partner, and what sort of characteristics do you look for in a potential partner?
The strategy is, I think, no secret. We we we want to find a partner who can actually bring this to the market. So the strategy here, we need to have a partner who has the capacity to actually run trials together with us or by themselves and to build the marketing effort around around the product. So this this means mid size small to mid size, but with commercial ambitions companies or large companies.
And with the upcoming initiation together with Otsuka of the phase one b study with seven five seven, what are your expectations in terms of data and information that you hope to gather from the study?
Oh, that that's a lot. As I as I alluded to, we call this a signal finding study. We are embarking on a program which is a little bit different than previous programs we've run. And this is, in part, learnings from Hotsuka and learnings from our own efforts in with Mr. Gautam and Peter Pimat.
We've combined those. So now we're looking at a broad spectrum of endpoints in these patients, stretching from motor function, of course, this is Parkinson's patients, but most importantly, the neuropsychiatric aspects of of, cognitive aspects of, the treatment profile. So we are collecting data on a number of, areas which is which are important to describe this patient population and also describe the effect of the drug. So it's gonna be a huge dataset that we generate in this trial.
But we can also add that we call this study signal finding study that is quite new, I would say, use that terminology. But I would say that it's very similar to getting to a proof of concept to see that it works in patients, which which is also the goal for us.
Yes. I understand. And, of course, besides the business development efforts and clinical development, IP protection is also a big part of running out biotech company. Now what is your view on the current patent situation of your leading candidates?
Oh, that that's that's one of the best areas, I would say. We're a really good area. The the experience in this team is huge on this aspect. And, as I alluded to, we have continuously built on the IP portfolio for both Maestroppertom, Pyrrpmat, and for the other assets, including seven five seven. And that is when we do this make make discoveries during the course of development.
We immediately patent those discoveries, if they are patentable, of course, inventions. And this has led to the situation where we have the whole portfolio that we have has the potential, for compositional matter based exclusivity well into the forties. So for instance, for, as an example, for Mestopotam, which is on the brink of starting phase three, we have the potential actually to get it launched with the maximum fifteen years of exclusivity allowed on any market based on patent exclusivity. The average in the industry today is around seven to eight years.
Yeah. And I would like to add that this is really one of the strengths that Eurolav has with those very extensive patent times and lives. And having worked both in big pharma and other smaller biopharma companies, I never seen such a fantastic patent portfolio like this one. It's something really we can be proud of.
Yes.
Great. And those were all the questions that I had for today. So thank you for having me.
Thank you. Thank you, Kevin.
Thank you, Kevin, for those questions. Very good ones, I might add. If we look at 11:17 again, approximately what time could we enter Phase two with 11:17?
That's a trick question. It has several vectors, that question. Because with this program with the program and we haven't really shown the program that we are considering here. But the next step, of course, IND enabling studies, tox in two species, then finalize the of course, finalize the GMP manufacturing. But then in the phase one program, which, of course, usually starts with healthy volunteers and go and then you move on to phase two in in patients.
But here, we see an opportunity to actually move quite quickly already in phase one to patients, which means that the year we start or when we start the clinical program, we already have a plan to get as quickly as possible into patients. One of the benefits with this type of molecular strategy to treat Parkinson is that we have the potential to immediately see an effect after one dose in Parkinson patients. And that's quite unusual for a clinical development program. It usually takes years to tease out the effect, look at mesdopotam, look at pyrimod, where are the effects, where can we actually build a commercial case around the assets. And here, we see an we can see an immediate effect after one or two doses of the drug.
So that will be within the eighteen month period that we have outlined in the presentation today that we have started a Phase one at least.
Okay. Thank you very much. And at the end of the period, you had SEK 89,000,000 in cash. What is your current view on financing going forward?
Victor, I think this is something for you.
Yes, it might be. Well, a lot of it is intended to use for the July study, of course. So that is fully financed, and we will use the money needed to fulfill everything that's needed in that study. And then, of course, we have ongoing activities on the BD side, and we're thinking about other structures as well to increase the cash and the runway, of course. So I think that is as much answer we can give at the moment.
Okay. Thank you, Victor. And as it looks, presentation and the Q and A is crystal clear because there are no more questions in the live chat. So by that, I want to thank the members of the executive team at Eirleb for your presentation and the Q and A.
Thank you so much.
Thank you so much for everyone to joining this call. Have a good day.
Thank you.
Okay. Thank you. And to all the viewers, thank you for participating and look out for the next interview with EirLab. Thank you.