Thank you.
Welcome to the IRLAB Audiocast with teleconference Q1 2022. For the first part of this call, all participants will be in listen only mode, and afterwards, there will be a question and answer session. Today, I'm pleased to present CEO Nicholas Waters and CFO Viktor Siewertz. Speaker, please begin.
Thank you very much for the introduction. Everyone, welcome to the Q1 report at IRLAB Therapeutics and to this webcast. IRLAB is on the mission to transform life for people with Parkinson's disease, developing a number of important new treatments. Can we please move to slide three? At present, IRLAB is in an accelerating phase of development. We have had strong development in our operations during the Q1 , enabled by a relatively strong cash position, which means that we are now investing further into our pipeline, broadening the asset, the portfolio of assets. This is to some extent enabled by our recently finalized licensing deal with Ipsen, which is a global neuro pharma specialist.
We have two programs right now in phase IIb clinical development. Further, we have also added a number of preclinical development assets into the pipeline in recent time. We also experience an increased interest in engaging in discussions with IRLAB concerning our assets over the past three months. Slide number four, please. I will leave the word to Viktor Siewertz, our CFO.
Thank you. All the financial summaries from Q1, we see that we have net sales of about SEK 9 million, and SEK 7 million of those comes from the deferred income that relates to the finalization of the phase IIb study with mesdopetam, which we are responsible for. We also see that the cost increase a little bit, and I will get back to that. If we change slide to slide number five. We are now, as Nicholas alluded to, investing in the phase IIb programs for both mesdopetam and pirepemat according to plan. We're also investing in our preclinical development, where we have the IRL757 and IRL942 compounds that we are in the final stages of preclinical development before entering phase I.
If we look at the cost, we see that they increase during the last quarters. We are happy, proud, and humbled. I can say that we have put ourselves in a position where we actually can accelerate the development in the way that we do now, especially considering the quite difficult times on the capital markets that in general and for biotech companies, especially. But with the amount of cash we have right now, we can be aggressive and invest in these programs. It also means that we can invest in our employees, so we are continuing to increase the number of employees we have during the Q2 or in May.
We have added even more personnel working with artificial intelligence and applying artificial intelligence methods to the extreme amount of data that we have in our ISP. All in all, cost development according to plan and what we have communicated earlier, and a relatively strong cash position at the moment. Next slide, please.
Slide number six. During the Q1 of the year, we have had a very strong operational focus on advancing the mesdopetam phase IIb study, the study we are running in collaboration with Ipsen. We are now also advancing two new assets towards phase I. We have initiated the preclinical development phases of both IRL942 and IRL757. An interesting development occurred in the P003 program. It's a program where we're looking at a new strategy for treating the basic symptoms of Parkinson's disease.
We acquired some know-how and some assets, which will support development of our own IPR in this program. We envisage the nomination of additional CDs during this year in that program. Of course, we are continuously activating and working with our ISP, developing the platform, the discovery platform further. Please move to slide seven. This is an illustration of the now growing portfolio of assets aiming at transforming the treatment for Parkinson's disease. We have also during the quarter decided to broaden our scope a little bit even outside of Parkinson's disease, and I'll come back to that. Primarily looking at IRL757 for neurology and apathy. At the top, of course, we have mesdopetam, which is in phase IIb.
It's directed towards levodopa-induced dyskinesias, but also PDP psychosis in Parkinson's disease, which we are working together with Ipsen to get to patients. The pirepemat program, which is a quite novel strategy to address one of the largest problems for Parkinson's patients, that is the falls and impaired balance. We have initiated the phase IIb study there. This is a molecule also which we can see broadened applications as we go along. IRL942 and IRL757, as indicated, we have moved those into preclinical development. For the P001 project, we are looking at nominations of CDs during the year.
As we have communicated, we have a very specific strategy to find partners at various stages for these assets. Clinical data is of course a nice inflection point, but also looking at the possibility of developing earlier stage collaborations. Slide eight, please. With this quite broad and deep pipeline, we also see in the coming two years a quite substantial news flow from the pipeline. We have the perhaps most important inflection point coming up during this year in the fall. That is the data from the ongoing phase IIb study with mesdopetam.
Following that, we see the start of a phase III study, but also we also see initiation of activities around the psychosis indication in Parkinson's disease. Of course, all the market preparations needed. These are of course decisions and activities led by Ipsen. Looking at pirepemat, we have started the study. We expect to see top-line data late 2023 and initiation of phase III in 2024, according to our plans. With the addition of a number of preclinical assets, we also see that we will have a lot of information to disseminate during the coming two years from the preclinical stage to phase I with initiation of phase I studies in most of these programs during 2023.
Slide number 10, please. Thought I'd say a few words about the preclinical assets. We haven't discussed those at length before, so it's time to do that now. IRL942 is a new type of treatment strategy for cognitive dysfunctions. This is of course a problem, cognitive minimal cognitive dysfunction and cognitive dysfunction in general is quite common. About 12% of all adults over 65 experience cognitive decline. This is according to the CDC. In neurological disorder, of course, that number is much higher. The problem here is a loss of activity in the frontal cortical lobes. Neuronal activity goes down, leading to these symptoms.
With IRL942, we can actually see in our preclinical data that we have now found a molecule which across a broad number of modalities, cognitive modalities, we can actually see improvements with IRL942. Which to us means that we have a unique asset here in terms of potential to treat cognitive dysfunction across neurological disorders. Slide number 11. Moving to IRL757. This is a program which we have developed in response to the huge need of a treatment for apathy in neurology and in other disorders, of course. About 20 million people in the U.S. and EU may be affected by apathy according to published data.
This is a huge problem, very much so in Parkinson's disease, but also in other types of neurodegenerative disorders. There are no treatments available today, no approved treatments available today. We see about 20%-90% of all patients in each indication area are suffering from these problems. IRL757 offers a solution, going straight towards the mechanisms driving apathy in the brain or the loss of activity connecting the frontal lobes with subcortical regions. We have data supporting IRL757 strengthening these functions, but also improving cognitive and affective symptoms. We're now embarking on a program where we will actually expand our ambitions beyond Parkinson's disease into other neurological disorders with IRL757. Next slide, please. Number 12. This is our youngest program, P003.
It's a project where we are looking at the next generation of treatments for Parkinson's disease. We're now talking about the core symptoms of Parkinson's disease. About eight to nine million people are diagnosed with Parkinson's today. This will grow to about 14 million people or 50 million people by 2040. They have a number of options today to treat their core symptoms. The mainstay treatment is levodopa. Levodopa has a number of problems associated during the course of treatment, which is lifelong. We think that with this new technology that we are developing in the P003 project, we have the opportunity here to prepare a treatment which will avoid many of the problems associated with levodopa treatment.
The status currently is that we are in the first generation. We have a lead optimization program ongoing where we expect to select CDs during the year. We have a second generation compounds in the making also looking at structural chemistry and ISP-based discovery. An interesting development in this program is that we did an acquisition of know-how which will support development of IPR in this program. Next slide, please. Sorry, slide number 14, please. Going back to our most advanced programs, pirepemat and mesdopetam. Pirepemat is a program which is designed, or a molecule which is designed to treat falls in Parkinson's disease and reduce fall-related injuries, of course. Impaired balance and fear of falling is quite common in Parkinson's disease.
About 45%-50% of all patients suffer from this problem. Pirepemat is specifically designed now to treat this. If we go to slide 15, we can see what activities have been done in this program during the Q1 . We have received regulatory approvals from all countries participating in the study during the quarter. It started with Sweden actually end of last year, followed by Poland, Spain, Germany, and France. The study has started during Q1. We have now full focus on expanding the number of sites and hospitals to participate in this study. We expect this study to have a recruitment time of about 18 months.
Top-line result is planned for end of 2023. Next slide, please. If you look at the developments in the mesdopetam program, this is a program where we are looking at treatment of levodopa-induced dyskinesias, which affects around 30% of all Parkinson's patients. It's a debilitating consequence of levodopa treatment. Sorry, just to make sure we're on the right slide. Slide 17. Slide seventeen. The development during Q1 has been that the study enrollment continues according to plan in general, I would say, with a strong focus now on completion of the study during the first half or so of this year.
We are looking at a noticeable impact of COVID-19 during the winter, in terms of recruitment pace, an experience that we share with basically the whole pharma industry. There was a surge both in Europe and U.S. of COVID, and hospitals have been directed towards focusing on COVID treatment. Despite that, we have been able to recruit during this period, and we are extremely proud that we have been able to continue this study during this quite difficult period. In collaboration with Ipsen. We are preparing for the phase III studies, and we are supporting Ipsen developing the CMC for phase III and market.
We are also, of course, working together on the clinical development and the preclinical development aspects that are still needed to be done to reach the situation where finally one can make an NDA. In general, we've had a quite substantial development of our operations during this year this Q1 of the year with new colleagues coming on board to support the broadening of the pipeline and the work that we have taken on. We have also seen increases in the number of or increased number of CDs that we are developing. Slide 19, please. At present we have really set the foundation now for these transformative treatments in neurology and Parkinson's disease.
We are on the path to deliver quite strong growth in our operations over the next coming years, where we look at applications for market authorizations 25-27. Thank you very much for listening. We have now opened up for Q&A. Slide number 20. Q&A.
Thank you, management. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. We have a question from Fredrik Thor at Redeye. Please go ahead.
Please, Fredrik.
Hi. Can you hear me?
Fine. Yes. Now we hear you.
Perfect. I was wondering about 942 and 757, and you mentioned the broad potential in several potential indications. Given your experience with Parkinson's, but maybe some other indications could be even larger, for example, Alzheimer's. It would just be interesting to hear your perspective a bit on how you work to prioritize on indications, especially initially, if it were to be, for example, Parkinson's or some other indication.
Yeah. That's a very interesting question and a very important question to actually. There's no simple answer here. However, of course, our core interest is the Parkinson's space, and that's where we have our main expertise. Having said that, apathy, for instance, for 757 , apathy is a problem which goes across neurological disorders. Of course, there are other types of neurodegenerative disorders where we could see use of 757 or drugs like that in the treatment algorithm. We are quite open here internally to move into other aspects of neurology with this. We haven't made any decisions at this time. When we have, we will communicate those.
Parkinson will remain our main focus initially.
Perfect. I was also wondering about, you mentioned a broadening of IR activities or function in the U.S. I was just wondering if you can e xpand on that a bit.
Absolutely. We have been extremely fortunate to engage in a collaboration with a very experienced IR person in the U.S, Jörgen Winroth, who used to be working for, once upon a time at Astra, but also more recently at Sobi. He's supporting our efforts now in the U.S., and he's working to expand the understanding of IRLAB and the knowledge about IRLAB in the U.S., but also in Europe, of course. Utilizing the networks he built over about 20-30 years working for Astra and Sobi.
Interesting. I was also wondering about the acquisition of know-how of P003. If you could-
Yes.
Expand a bit on the IP situation overall for that program, if you can elaborate in some way, how this strengthens the IP situation.
Yeah. The know-how that we acquired pertains to certain chemical expertise, of course, defined structures and defined pathways. These are necessary for us to prepare our, let's call them, candidates. They're not nominated yet, but let's call them that, our molecules or lead molecules in the program. This supports very heavily the patent estate that we're building around these assets. Does that help?
Yes.
In terms of explanation.
Obviously. Maybe a final question from me. You mentioned the heavy COVID impact earlier this year.
Yes.
Do you have any insight into the situation right now? Does it seem more stable? Yeah, how does it compare to earlier in the-
I'd say right now it from the information we've gathered, it's quite stable. It's still there. COVID is still a problem. And as you know, we are running our studies in Europe and in the U.S., for mesdopetam and for pirepemat, mainly in Europe. And Eastern Europe is part of this. It's not only the COVID situation, it's also the crisis or war in Ukraine that may have impact on hospital availability, engagement during the spring here. But having said that, what we've seen is a stabilization across the sites that we are working together with and the physicians we're working with.
We have seen an uptick in the patient recruitment pace during the Q1 . It was, of course, quite slow during Christmas and when the COVID-19 Omicron wave came over Europe.
Mm.
It is stable now. We have, and once again, having said that, we have been able to recruit all the time.
Perfect. I think that's complex times but appears to be more stable.
Yeah.
Yes, that's all for me. Thank you.
Thank you. Ladies and gentlemen, I remind you that if you want to ask a question, you have to press zero one on your telephone keypad. Once again, I remind you that if you want to ask a question, you'll have to press zero one on your telephone keypad. We have a current question from Gonzalo Artiach Castañón at ABG. Please go ahead.
Hi. Hope you can hear me.
Yes, perfectly.
Hi. Thank you for taking my questions. I have two of them. First, before the announcement of IRL757, you had two public drug candidates in the P001 program, IRL942 and IRL1009, for which you got patents in Europe and in the U.S.. Is IRL1009 still a candidate to move to clinical trials, or what is the current situation with this drug candidate? My second question is regarding IRL757. What would be an optimal primary endpoint in a potential efficacy trial for apathy? Are they similar to the endpoint evaluated in depression?
If I start with the second question first. There are very specific and well-defined apathy scales which will be used as the primary efficacy scales in such trials.
Okay, thank you.
To the first question, we have 942 has been the CD in that class. We've had 1009 has been the backup compound. It's still a backup compound in the program. Now that we are developing, we have initiated the development of 942. We thought it was quite prudent of us to actually put 1009 a little bit in the background. It since it's not the asset that we are moving forward. We have also now chosen 757 for apathy, which shows quite interesting neurobiological effects, going beyond what we see with 942 and 1009. We're differentiating from that molecule, those molecules.
Okay, great. Thank you very much.
Thank you.
Once again, I remind you that if you want to ask a question, you have to press zero one on your telephone keypad. There are no further questions at this time. Please go ahead, speakers.
Thank you very much for listening. I hope you have experienced the quite exciting situation that IRLAB is in. We are moving forward on many fronts and the company is really thriving right now. Thank you once again for listening.
This now concludes our presentation. Thank you all for attending. You may now disconnect.