IR Lab Therapeutics have reported the Q3 for 2023. The company will now give a presentation followed by a Q and A. Viewers can also ask their questions in the live chat. So to present the Q3 in the digital studio, I am happy to hand over to CEO, Doctor. Gunnar Olsson.
Welcome, Gunnar.
Thank you and very welcome to the Q3 update from IR Lab. Today's agenda is as follows. I will start by giving you top line news in the period. This will be followed by an R and D update given by Niklas Waters, our Head of R and D. We will then have Victor Sievers, our CFO, to take us through the financials.
I will then end with some concluding remarks And we move over into the question and answer session. So operational highlights in the Q3, Starting with Piritmat, in July, the Data Safety Monitoring Board, the DSMB, have their first pre planned review when the first 25 patients have completed the study. The DSMB gave us a unanimous recommendation to continue the study according to plan. For mestopetane, on the 21st August, we secured the full ownership and all rights For the now Phase 3 ready mestopitant project, we also communicated our intention to continue with the development of the product. When we have secured the ownership of the product, we could also present all the data from the completed Phase 2b study.
So on the 22nd August, we have a webcast. The results of the study was all were also presented at the MDS Congress in Copenhagen. The results in the show in short, they showed a dose dependent clear anti dyskinetic effect and a dose dependent anti partisan effect and this coupled with a safety tolerability profile That was on par with placebo. This is development and financing. During this quarter, we have substantially increased our activities in the evaluation of potential collaboration partners and licenses.
With investors, we've continued our financing activities with participation in investor conferences as well as discussions with financial advisers and investors. Events happening after the period in West Ope town in October, We've communicated our collaboration with our regulatory advisers in the United States. Pietrok, as our regulatory agent in the United States, opposite the FDA. And we're now together compiling the briefing document that needs to be put together before we can approach the FDA and ask for meeting, a so called end of Phase 2 meeting with a purpose to define the Phase 3 program. Regarding investors, we held a Capital Market Day last week on October 17.
And for those who have not had the possibility to attend or see the live send on the debt, I give a recommendation to look at the recorded version that can be reached link from our home page. Financial summary. During the Q3, we had no net sales. Operating profit, minus SEK 40,700,000, earnings per share minus SEK 0.74 cash, SEK 118,800,000,000 cash flow minus 36.7 percent, average number of employees 31 share price at the end of the period, SEK 7.38. So with this short highlight of key events.
I think it's time now to go to the R and D update. So please, Nicolas, Could you take off? Thank you, Gunnar.
Thank you everyone for listening in today. I'll give you a brief talk on the strategy and the activities ongoing at IR Lab in terms of the development of our products. 1st of all, IRLab, as you know, has a very strong focus on Parkinson's disease. The pipeline is based on What we have learned about the complications in Parkinson's disease during the past 30 to 40 years. Recently there came a study published by the Michael J Fox Foundation or an investigation run by the Michael J Fox Foundation.
A look at what the patients actually find to be their biggest problems. And among those is course balance and instability, which is the biggest problem in Parkinson's disease. And then of course, as a second problem. Still, the treatment of the basic symptoms, tremor, rigidity and bradykinesia, It's still high up on the charts in terms of medical needs. Then of course neuropsychiatric aspects of the disorder as well: cognitive decline, mood and neuropsychiatric symptoms such as psychosis, anxiety, But also the dyskinesia that we are addressing.
Parkinson's disease is a progressive disorder where there is a development of symptoms over time. The first symptoms observed are usually tremors, which is followed by bradykinesia, that slowness of movement and rigidity, that stiffness in the musculature. On top of that, Patients experience a number of additional symptoms over the years, such as hallucinations, confusion, depression, Pathy, cognitive impairment and psychosis, but also motor complications due to the treatment with levodopa. And at Eelab, we are addressing all these aspects of symptomatology. So we're not only focusing on slowing the progression of the disorder, but instead focusing on improving a de symptomatology or reducing symptoms and their effect on daily life.
So, miss Mestoepatam is in development for dyskinesia, but also hallucinations and psychosis. Look at Piripemat, which a improves has the potential to improve balance and falls, but also cognitive impairment, speech and swallowing difficulties. 11,757 is a drug we are now developing specifically to treat apathy, And this is a project where we're looking of course at Parkinson's disease, but this is a molecule or a project where which we actually can stretch out into other indication areas in other neurodemential disorders such as Alzheimer's, for instance, but also frontal temporal dementia. 942 is a molecule which has a very broad cognitive enhancing properties cross different cognitive modalities and we believe this could be a really useful tool in the treatment of cognitive impairment in neurodivergent disorders, including Parkinson's disease. And more recently we have nominated a IRL 1117 as a candidate to treat the basic symptoms of Parkinson's disease, that is the slowness of movement, rigidity and tremors.
But also treat those without inflicting the fluctuation and complications that are associated with treatment with levodopa. So this makes up a very broad pipeline covering all the aspects of complicating symptoms for these patients. Few words on Mestep Atag. You who have followed us for a while during the fall have of course a deep understanding and I've seen what we have published so far when it comes to mestopodone. But this is a first in class novel compound with a novel mechanism.
It primarily inhibits dopamine D3 receptors in the brain, which are responsible for the genesis of this Kinesia. And one important aspect of this project or this product is that we have We believe that we have we can have exclusivity into the 2040s based on the IPR estate that we have developed. And this is a very long period, I assure you. The lead indication here is levodopa induced dysgenesis, a We can see a number of life cycle management options here in terms of adding indications, but also into other populations such as target dyskinesia. We have generated a lot of data on Maestro von Ton and during the what we call the learning phases from Phase 1 through Phase 2 entering now the pivotal stages of development.
We have learned a lot about this molecule and generated sufficient data to be able to go to the FDA and have a discussion on the development program. And as Gunnar mentioned, we are now preparing forward meeting with the FPGA to design the final out the final design of the Phase 3 program. We have shown these data at a number of occasions during the fall a without any impairment of multiple function or other functions for these individuals treated with mestopeton. We see consistent dose response pattern across key endpoints meaningful and important to regulators such as off time, good on and the regulatory preferred scale, the Unified Dyskinesia Rating Scale. Then we have a safety and tolerability profile which is on par with placebo at maximum or optimum efficacy, which positions Mesto Potam as unique asset in this space.
We have also decided on a dose for the further study, 7.5 milligrams BIDIG. New words on peripamult. This is a compound where we are looking for the first time, we believe in history looking at reduction of force with a sponsor finance project. This is a 1st in class novel mechanism. We are inhibiting alpha-two and serotonin-seven receptors in the frontal lobes of the brain, leading to activation on the paths in the cortex which are involved in the control of balance.
We will see with this program have a patent based exclusivity into the 2040s. And the ultimate objective of this program a is to reduce falls or reduce the risk of falling in Parkinson's disease. And this is the number one issue cue for Parkinson's patients today. And about half of all patients diagnosed or individuals diagnosed with Parkinson's disease. They fall recurrently once or twice a month up to several times a day actually.
And this is dependent on a number of mechanisms in the body, but Primarily, the loss of activation of cortical function is responsible, which leads to cognitive decline, impaired balance leading to falls and quite substantial costs for the individual and for society. And this is a very important project for us, but also for the payers around the world who are paying for these fall injuries. Also here, we have generated a similar set of learning data from Phase 1 through Phase 2a and we are currently in the middle of a Phase 2b study where we're looking at patience with recurrent falls or high frequency fallers across Europe. The idea here is to evaluate the effects on false frequency, balance and postural dysfunction, but also on cognitive functions and neuropsychiatric endpoints. And this is to prepare for a pivotal program.
Look at the market for a product in this space, there is a huge number of patients across the globe that are in need of a balance improving strategy. We expect to have completed recruitment during the Q1 this year and be able to we hope to be all aiming to report top line results during the spring of next year. On top of these 2 advanced programs close to Phase 3 and in the middle of Phase 2b, We have 3 candidates in preclinical development. That's 757 where we're looking at addressing apathy, which is an unmet medical need across neurological disorders and especially so in Parkinson disease. We see that there is a quite large population in the main markets around 1.1 to 7000000 people affected by apathy.
We are right now completing the IND enabling or CTA enabling studies in Europe and we are preparing this molecule for Phase 1 right now. With 942, we are focusing on improvement of cognitive function and also here we are in the middle of IND enabling studies. We expect to have this project ready for Phase 1 during next year. And for 11.17 similarly We are developing the IND enabling program right now. We are working on the CMC development, But we also have here a very, very large population that is eligible for treatment around 6,000,000 people.
And we expect to have reached Phase 1 readiness by the end of next year. So with those concluding remarks, I will hand over to Victor to talk about the finances.
Thank you, Niklas. So a few short words about the financing or finances. We had a cash position in the end of the quarter at about SEK 119,000,000. The cost, as we can see in the middle graph on this picture, are decreasing and that is partly result of our cost control and partly a result of the declining cost in our clinical projects. What we do now is that we prioritize costs that will preserve or increase the value of the projects that we have.
So, that's how we look at the cost at the moment. So we are investing in the Phase 2b with burep mod And we are maintaining the investments in the preclinical projects as well in order to make them Phase 1 ready. When it comes to headcount, we are still around 30 or 31 employees. The number of employees We'll probably remain stable as we believe that or it's proven But all the employees are invaluable to us in all the projects or all the activities that we are doing at the moment. These are the analysts that covers us, so and they will come in after this presentation with questions.
Hand with that, over to you, Gerhard.
Thank you, Victor. So a couple of concluding remarks From me before we enter into the question and answer session. First, I just want to remind you of our strategy in the company. We are addressing all stages of Parkinson's disease and also other CNS disorders when symptomatology is similar to that with the Ian Percocil. We are discovering novel candidate drugs With our unique ISP platform, the platform to generate discovery, This results in true innovation, higher success rate than the industry standard And it gives us strong IAP position.
We're developing our candidate drugs from discovery to proof of concept And then we are seeking a partner after proof of concept to take the product onto Phase 3 and later conversation. With BEST Orbital, we have had the Phase 2 readout and we are now preparing for the end of Phase 2 meeting with the FDA to define the Phase 3 program and we've secured the full ownership and rights to the product. With pyridinib, we'll continue the Phase 2b study. All the clinical sites now are open and running And we've had the 1st pre specified DSNB evaluation with the advice to continue. For 11.17, this is a CD that we selected early this year And it's start to the preclinical development activities.
And for 757 and 942, We have continued preclinical development, so we are now in late preclinical development and we'll see Phase 1 Readiness in the near future. This means that the portfolio has actually grown quite a bit. So we can now say that we are in a world leading position in Parkinson. Parallel with the progress in the portfolio. We have also increased our ability activities.
Multiple opportunities for evaluating and this has resulted in this picture of the portfolio. West Oppetal developed for level of induced dyskinesia now aiming for the end of Phase 2 meeting to define Phase 3, piretumab for reduction in risk of falls in Phase 2b study. We aim to have top line results by the end of first half next year, 757 for apathy, of course in Perkyosol, but also in other neurodegenerative diseases where apathy is a common symptom, Phase 3 by end of this year, 942 full treatment on cognitive impairment, of course in Parkinson patients, but also in other neurodegenerative diseases where cognitive impairment is a common symptom. Phase ready first half next year and last but not least, 11.17, where we now are in preclinical development and hope to see this to be Phase 1 ready by end of next year. Some words about business development efforts And as I stated, we have substantially increased our activities.
And we now see awareness of IRULA And the development pipeline that awareness is increasing and that is good news. We continuously have dialogues with potential partners and we do it frequently. We have partnering opportunities across the entire portfolio, but the near term focus for us that it So our key priorities, As Victor stated, they are now focused on value creating activities. So in clinical development, it is to get to the end of Phase 2 meeting with the FDA for nestopto, it is to complete the Phase 2b study with piritmab a So that we can present top line results. In the preclinical development phase, it is about to get The 3 preclinical products into Phase 1 readiness.
And on financing, We are working to increase capital base to enable further value creation, and this is through business development activities and or other financing opportunities. So in the business development space, we continue dialogue with potential collaboration partners and licenses. And on the financing opportunities. We continue dialogues with financial advisers and investors. So when we look ahead of us the next 18 months, we will have multiple possibilities for high value creation in the project portfolio.
We stopped it on the end of Phase 2 meeting And following that or parallel to that, I should rather say, business development activities with Piracnet, The top line results and business development activities for Phase 3 and pre clinically 4,757 and 942. We are getting them ready for Phase 1 and we have development collaboration discussions. 11.17, make it Phase 1 ready and start of Phase 1. So I think that this concludes the presentation. I think that we should now move over to question allowances.
Thank you so much, Gunnar, Nicolas and Victor for that presentation. It's always very interesting to listen to all your progress and all your activities. And like you said, it's time to move on with the Q and A. And I would like to start off by inviting Sue Romanov of Edison Group. Please, Sue, go ahead with your questions.
Thank you for the presentation, it was very helpful on your CMD. What are the key learnings that maybe you've Taken away in comparing the FAS data to the PS data, and would that influence your future plans?
So I think that the study was assigned to the dose finding study. And if the dose finding study, You really want to know what dose gives what type of effects, and that means that In such a study, you always do both the fast population analysis, the ITT, as well as you do the per protocol analysis. They have slightly different meanings. The per protocol analysis, which represent the PS population. That is really to determine what is the right dose that we should take when we continue our development activities.
The ITT, there is more to say, could the study qualify as a pivotal study And your future regulatory interaction. So but that is really Why every time you do a Phase 2b study, you do both of these analyses.
Recruitment for the purpimat study on the back of the, you know, the nice progress we've made so far.
We are constantly looking into the study and the recruitment development And we are taking actions with regard to see that we can do a Whatever we can to have as good retrofitment as possible. I don't know if, Niklas, you would want to comment further On the Pirkanet study?
Not further, but I can deepen the response a little bit and that is that We are of course working together with our CRO, which we have been doing since the start of the study, to incentivize the patient, both patients and the sites to work hard and get the patients in. What we have learned during the course of the study is that it's a quite complex protocol where we have a number of visits at the sites and this is of course always cumbersome for patients of this type. So what we are looking at is perhaps doing some home calls instead of having patients to come to doctors. So that's one thing, one example of an activity that's possible to make this a little bit easier for patients to participate. So that's one thing.
And there are other things also, of course, that we are implementing as the study goes on and we've been doing this since the start of the study.
Yeah. And I think, the last a It was kind of nice to see this big transaction in the market, you know, for Parkinson recently and I don't know if we have any Nice, any takeaways or anything like that since we're always looking at Comparable transactions and how that helps UrLab?
Well, of course, always when we have our partnering discussions, we keep an eye on benchmarking with other deals. Having said that, we should still say that every deal is unique because it depends on the needs From 2 parties, the taker and the givers of ZEP. What I think is very positive for us that is that we have Now, how should I say? We have busy times in interacting with potential partners and as I've stated, it is high on our agenda. It is a prioritized area for us.
At the moment, we have the key focus on messed up a tonne and for the 2 preclinical product 757-942.
Great. Thank you so much.
Presentation. Thank you, Sue Romanov, and let's move on to Gonzalo RTIAC at ABG Sundal Collier. Hello, Gonzalo.
Hi, good morning. Thank you for taking my questions. A I have a question, a follow-up on the recruitment of the Pirabenat study. In the report you mentioned that the recruitment has been slower than anticipated during the fall. Is there any specific reason beyond the ones that you already mentioned, Nicolas?
Is there Yeah, I was wondering why the pace has gone specifically slower in the fall and what are the main reasons?
Yeah, it hasn't been specifically slower a In a huge sense, it's just we want to be clear that there is periods where recruitment are faster and peers are very good but are slower in any study. And this fall we've had a little bit less an inflow into the study. But we believe that will change now. We are doing some remedies and we are incentivizing the sites a to our Carter together with us and our CRO. But this is a way for us to basically communicate a progress without having we cannot really give details on data, but soft wording like this helps You and others to understand the stage of this time.
Thank you very much. And the second question, I was wondering, well, regarding your preclinical assets, 757 and 942. Let's say or let's put ourselves in a case where you have both assets, Phase 1, ready in 24. Which one would you prioritize? Or what are the plans for both molecules?
Would you like to move them forward simultaneously? Or would you prioritize 1 of them?
From a corporate perspective, I mean, there is no reason to wait with one before the other. There's no reason for us to slow development. So So it's full steam ahead for both. If one looks at the indication areas, the apathy is probably the most exhilarating for us since there is nothing out there to support patients. There are treatments for cognitive impairment already, but we of course we think 942 could be better, but when looking at apathy, there's nothing there.
A program that may come obstacles. If we look back in time and look at our parallel development of Piru Pan Mart and Mesto at the time, Those who have followed us for many years can see that at times, Mr. Ophodham has been ahead and at other times, Pirtmann has been ahead. A And that's a strategy that we have adopted over the years to have a number of assets ongoing at the same time. That's really important So that you really have you can push your priorities towards those that look to go faster.
Now we're a We're very lucky with both first half of the time period month that they have been surviving all the complicated studies they've gone through so far. And we hope to see the same thing with the rest of the pipeline, of course.
Great. Thank you very much. And one last question is regarding the collaboration ongoing collaboration you have with MSRD. You're mentioning in the report that you're evaluating the possibility of a collaboration for the development a Of the clinical development of both molecules, 9421757. I don't know how much can you say here, but I was just wondering if Any potential decision for future collaboration would come once the assets are Phase 1 ready or it would come before?
And also, on the current preclinical development status, a And how much is Otsuka already involved as of today?
With the development I'll start with the last question. With development work At present, everything is run through IRVA. With regard to collaboration, we are in discussion with MSRD, a company within the Otsuka sphere. We are in discussion about potential collaboration. It is always very difficult to give a specific timetable for such discussions when they come to a decision point.
I wish I could give you better guidance, but definitely the discussions are ongoing. And as soon as we see They were coming to a decision. We will, of course, communicate to the market.
Great. Thank you very much.
Eippens Fredrik.
Yes, hi and thank you. Yes, it was mentioned in the report a bit about the end of Phase 2 minute thing and that you're preparing for it and have hired consultants and so on. It would just be interesting to hear a bit more if you could elaborate on a How flexible is the outcome of these kinds of meetings? How, I guess, important is it to have the right I assume that you think that is, but it would be interesting to have some more color on that.
Yeah, I think it's very important to have the right full amount of people to work with because going for interactions with the FDA is very difficult, difference from the process that you apply when going to European regulatory authorities. With these two groups, Kildrex and Pro Pharma Group, we have people with vast experience of the FDA. A Some of them have worked there, some of them have been key experts in their advisory committee panels. So we're very confident with them. And the reason why we have chosen to really try to get the That is because it is complicated and with the process in the FDA, You need to do it right the first time.
It is not so that you go there, you get some extra feedback, you go home and Try it another time. You wanted to be the right from the first time, and that is really why we have looked very carefully to select what we believe is the best people to work with.
Perfect. And a final question from Nicolas. In your C and D as well, a There was a discussion about accelerated approval and that's usually not possible in Parkinson's because of the lack of biomarkers. It's interesting to hear a bit maybe more broadly about if you could discuss the development of biomarkers and if that is something that you Precisely like in the near future for your projects or if it's very far away?
Well, Fredrik, biomarkers in Parkinson's disease have been notoriously difficult to find, Which have a good prediction. However, there has been a couple of progresses in recent time. Just during the past year that has a couple of publications where you where one combines a number of endpoints, measurable endpoints From the body in the blood, where you can actually predict the progression of Parkinson's disease, predict the severity of Parkinson's disease you can get. But these are far away from usable as clinical development tools at present. But we are keeping an eye on all the developments in other areas percent of hours such as for instance devices which can be used to measure motor function, which can be used to measure for instance falls.
The problem that we have as drug developers is that to date we are not aware of any such devices that are approved for use in clinical trials. You have to prove that they've actually measured what you want to measure a That is done in validation studies and we haven't seen such, but that will come. And this will probably simplify and reduce simplify studies and reduce the number of patients needed to see or to prove an effect. But that's in the future. A We do not see that as a viable strategy to include biomarkers in the pivotal trials since we haven't used them in the earlier studies.
So, but I'm hopeful. I think that all the brilliant minds out there We'll come to a conclusion on how to best describe Parkinson and other neuropsychiatric disorders for that matter by means of different types of biomarkers and tools.
Interesting. Thank you very much. That's all for me.
Thank you, Frederik. And there are no questions from the viewers. So I guess we just thank the audience for being with us, and thank you, Gunnar, Nicolas and Victor for presenting.