Idorsia Ltd ($IDIA)

Good day, and thank you for standing by. Welcome to the Idorsia Pharmaceuticals Daridorexant Pediatric Insomnia Results Conference Call. [Operator Instructions] Please be advised today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Kevin Boss. Please go ahead.

Thank you, Nadia. Good afternoon, and good morning, everyone, and welcome to today's webcast. We are here to discuss the positive results of the Phase II study of daridorexant for children with insomnia disorder, which we announced yesterday. On the call today, we have Jean-Paul Clozel, Chairman of the Board and Interim CEO of Idorsia; Martine Clozel, our Chief Scientific Officer and Head of Research; and Alberto Gimona, Head of Global Clinical Development and Medical Affairs. They will provide context on our daridorexant program and walk you through the key results from the pediatric study. Following their remarks, we will be happy to take your questions. Next slide. The information presented today contains forward-looking statements. You have therefore been appropriately warned about the risks and opportunities associated with investing in Idorsia. Importantly, to today's presentation, daridorexant for pediatric use is investigational and not approved or marketed in any country. Next slide. With that, I'll hand over to Jean-Paul.

Good morning, good afternoon to all. I am very happy to have the opportunity to join the call today and share some very exciting results. While we still have a lot of work to do in order to analyze the wealth of data generated, the top line results are very impressive. I hope you understand that we will share the detailed results at upcoming congresses and in peer-reviewed publication. To be able to protect publication in top-tier journals, we have to restrict what we share today. I am sure that you will agree with me that these results are very exciting. And I think what I also wanted to emphasize is that the fact that these fantastic results are really due to the very specific properties of daridorexant, which was chosen after synthesizing more than 25,000 products. And Martine will explain to you why this drug is so different and so exciting.

Next slide, please. In this study of 165 children suffering from chronic insomnia with or without neurodevelopmental disorder, we see a major improvement of sleep, particularly in those children with neurodevelopmental disorders. This alone is exciting. But beyond insomnia, the data suggests that orexin may play a broader role in children with neurodevelopmental disorders, potentially opening an entirely new therapeutic avenue for these patients. Next slide. We understand since [ Sakurai ] in 2007 that orexin, which is produced by only a very small number of cells in the brain is a central player in wakefulness. The very same year, we published in Nature Medicine that dual orexin has receptor antagonist, which we call DORA, induce sleep and a very good quality of sleep. Now we know that insomnia is characterized by another active wake signaling. And that DORA's are a very good way of treating insomia to inhibit the [ overactive wake signal ] by blocking the 2 orexin receptors instead of depressing the brain to induce artificial sleep as most older drugs in insomnia were doing. Next slide, please. But not all antagonist of the orexin system are created equal. We have worked relentlessly, even stopping the development of our first dual orexin to arrive at the optimal molecule. As Jean-Paul was telling, after 25 years of research, more than 25,000 molecules designed and synthesized are dual orexin and guided by the revolutionary work of computer modeling, we achieved what we were aiming for in our drug discovery and data. An antagonist of both orexin-1 and orexin-2 receptor, blocking both receptors with equal potency. With the rapid onset of action and the duration of action long enough to cover the night, but short enough to be divide of carryover effect even at the optimal dose for sleep. That's the best possible profile for a sleep drug. By that research goal, we wanted to avoid the pitfalls of molecules for insomia with suboptimal and too long pharmacokinetics, giving either the risk of carryover some somnolence in the morning or a sub-optimal efficacy when trying to avoid the disturbing risk of morning and daytime insomnolence by reducing the dose. QUVIVIQ has basically the perfect profile. As we can see on the right of this slide, fast absorption, fast decline and no accumulation over time. Next slide, please. Daridorexant, QUVIVIQ, really surpassed our expectations in adults with insomnia both on efficacy and on safety. It is an extremely effective drug, within adults, 1 hour more of more of sleep at night, improving both sleep induction and the maintenance of sleep, giving also a better quality of sleep, restoration of a physiological sleep pattern with, in particular, more sleep. Daridorexant works in all periods of the night with the largest efficacy in the fourth quarter of the night. Next slide, please. And yet, when we were checking if there was any carryover effect in the morning, there was none. The highest dose here in green of 50 milligrams per night did not induce sleepiness in the morning. To the contrary, thanks to the much better night and the exceptional pharmacokinetic profile of daridorexant, morning alertness was improved at 50 milligrams. Next slide. I believe that the better night sleep in combination with no residual somnolence and the equilibrated antagonism of both orexin receptor is 50-milligram also improves the daytime functioning so well. Using the insomnia daytime symptoms and impact questioner, so-called [indiscernible]. We found that QUVIVIQ 50 milligrams improved all 3 domains: sleepiness; alert cognition; and mood and all the 14 questions of those domains with an increasing effect over time. This makes QUVIVIQ the only therapy to demonstrate significant improvement in data and functioning in patients with insomnia. Next slide, please. Finally, as already mentioned, a very good safety and tolerability after chronic daily repeated administration, even on very long term. Next slide. You will now see that once again, we are impressed by what this molecule brings this time to children with chronic insomnia as young as 10 years of age. The burden of chronic insomnia is substantial, especially in children with neurodevelopmental disorders, such as autism spectrum disorder, or ASD, and attention-deficit/hyperactivity disorder or ADHD. It profoundly effect the quality of life of both the child and the family, yet there is currently no FDA-approved medication for pediatric insomnia in the United States. Alberto will now take you through the study design and these very important results. Alberto, next slide, please.

Hello. Thanks, Martine. Dear all, I'm happy to present to you the results of daridorexant study in children. As a note, I think Idorsia was the first company to start the program in children with the DORA. And given the daridorexant properties that Martine has just described, we actually were very eager to negotiate a program [indiscernible], and we did it with FDA and PDCO, with EMA. But first of all, let me thank the investigators together with the children, the caregivers who invested time to advance the science. And I'm happy to say that their time and effort was eventually very well awarded. Next slide, Slide 13. In this slide, you see the study design is a double-blind, placebo-controlled dose-finding study, where children were randomized to 3 doses. Please note, these are the same doses studied in adult, 10, 25 and 50 milligrams. The children, the parents had the burden of spending 3 nights, 2 at screening and 1 on day 1 at the sleep lab to undergo polysomnography, from which the primary endpoint was derived. And this is an important feature of the study is polysomnography and 3 cumbersome nights, but the children and their caregivers did it. One question you may see on the slide is that on day 1, the primary endpoint is measured. So it's baseline to night in sleep lab, day 1, there is a sleep lab, again. But why on day 1 and not at the end. Indeed, because health authorities were concerned about the discontinuation rate in children, particularly with those nights at the sleep lab. So they wanted to minimize the risk of missed data points by getting the primary endpoint as early as possible during treatment. And actually, this was probably driven by the experience they had with previous studies. But indeed, in our study, we have only 1 child that did not remain in the study until the end of the treatment period, giving the first hint that the drug was very well tolerated and actually, they indeed like the drug because they continue to stay in the study. Next slide, please, Slide 14. So as mentioned, the primary objective was the valuation of the total sleep time by polysomnography. Again, the study investigated 3 different dose, and the main point is the dose report -- the evaluation of the dose response instead of the [ per ways ] comparison to placebo. The study was sized to show those response. Next slide, Slide 15. And here, you see the stratification in the study, which is an important innovative feature of this study that I'm proud we were able to negotiate with the health authorities. In effect, that include patients or children with narrow development disorders as well as children without comorbidities. And again, this was done to accommodate both EMA and FDA. In the middle, there is also a group of patients with subthreshold ADHD ASD, which means that they did were not diagnosis, but at screening, we have tools, recognized tool to screen for symptoms in size of ADHD and ASD, and they did not meet the formal definition. Eventually, we were able to agree with both FDA and [indiscernible] that those response was evaluated under overall mixed population. Next slide, Slide 16. You see the demographic characteristics in this slide. And interestingly, there was 20% of children were down -- with age 10 and 11, which, in my opinion, honestly, is a great -- was a great achievement by the study team in considering and the investigator as well to convince the parents or the caregivers and the children to stay in the sleep lab for 3 nights. Another interesting feature is that we have 50-50 split between males and females. It's slightly different to the adult population where we have approximately 2/3 women and 1/3 man. The body weight is represented at the bottom of the slide, and you see that this expect -- as expected in this population. But actually, I would like to draw the attention, it's nothing to do with the study. But indeed, you see that the range of body weight were exceeding 100 kilograms for children in all treatment groups. So there is overweight and obese children in line with the increasing burden of this disease also in the pediatric population. Next slide, Slide 17. Baseline disease characteristics, the average time from the diagnosis of insomnia was approximately 4 years. And you see the 3 characteristics that define insomnia and they are difficult to get to sleep and maintain a sleep during night that were reported basically by all children. And actually, early morning awakening was a little bit less represented. But the most important feature of this slide for me is the fact that, as mentioned, we had already 30% of children with the diagnosis of autism spectrum disorder and ADHD, attention-deficit hyperactive disease. On top of this 30%, there was an additional 20% with subthreshold ADHD and ASD, meaning patients with -- children with feature symptoms but didn't meet the diagnostic. Next slide, Slide 18. I'm happy and proud to share that the study was successful and highly statistically significant dose response was observed. You see the p-value over there. In this study against the first regulatory study with DORA in children. Importantly, and the different versus placebo, at the high dose, the 50-milligram high dose with even nominally statistically significant difference from placebo. Again, this was not a requirement of the study, but the effects of so strong that we had also a statistical significance there. But further, the effect was particularly impressive. Actually, I would say with -- I haven't seen it earlier on with unprecedented increase in TST versus placebo in children with neurodevelopment disorders. Of course, this is -- we should be still be cautious because this is a dose finding study. But really, the results you will see when we publish are impressive. Let me say that there are still so many data that we need to analyze and properly interpret that we cannot say more. But -- while any conclusion cannot be drawn, I'm really excited about what we have seen beyond sleep. Here is a total sleep time, but we have other measures in children with the neurodevelopment disorder, that actually surprised me and excite me, and we are going to further analyze to put into a very nice publication that shows -- this data show that we may have potential impact on the disease itself and not just on insomnia. Next slide. Slide 19. I This, for the moment, what was already is -- a great achievement here of this study is that we can say already that the safety profile at the same dose tested in adults. So we have children with the body weight. I mentioned the high range, but I would also like to mention the lower range, which was about 28 to 30 kilos, even the highest dose 50-milligram was well tolerated and actually, there is no dose response on any adverse event, but also similar to what we have observed in adults also on event -- events of special interest such as excessive daytime sleepiness, suicidality or drag abuse potential, all adjudicated blindly by an independent panel. The word here, why we adjudicate some events by a panel because we don't want to miss any signal. And here, again, shows and make it robust to the fact that we did not see any dose response of any of these events and especially no event at all most of these categories, including drug abuse. Next slide, Slide 20. It's a very boring slide. And I will say thanks to whoever, but there is nothing here. Nothing really relevant when looking at adverse events reported by the children. And then you see all the adverse event reported in the population are in 1 table, which is quite exceptional. And you can see notice for -- and reaching to what Martine said earlier on. So we have very few adverse event 1 to 3 patients across group, including placebo, with somnolence and fatigue, which is the -- what we usually review when we look at the data in insomnia. Again here, no dose response. So eventually, the weight tolerability and safety to file observed in the adults seems concern -- confirming children. Again, same exact as [indiscernible]. Next slide. Slide 21. You have seen earlier the morning sleepiness, or actually, the name is not really reflecting what it measure. Actually, it's morning alertness reporting in adult population. Again here, we showed a similar measure in children. Again, the green bar is daridorexant at top of those and the blue is placebo. On top, you see the baseline and you see at week 2 after only 2 weeks, you observed that an increase in -- versus baseline of daridorexant 50-milligram and also an increase versus placebo. Again, the highest dose, we do not observe any sleepiness in the morning, rather a better, more refreshed pediatric population. And you see the scale from 0 goes from extremely tired to 100 [indiscernible]. Next slide, Slide 22, which is going to be my last slide. So with this data, what are the next steps. First of all, I'm looking forward to discussing this data with the health authorities, the PEDCO for EMA and the FDA to agree on a path forward to bring daridorexant into the children with chronic insomnia. We have, as some of you may remember, we have a bit in Europe, and we need to discuss also with EMA, the optimal path forward for the younger children cohort at -- below 10 years of age from 4 years to 10 years. This is what is summarized on the left of the slide. But equally, actually and really more exciting, we need to fully evaluate the surprising results that we see in NDDS, neurodevelopment disorder subgroups and then discuss with the health authorities about the potential program from children with NDDS beyond the treatment on this insomnia. But maybe here, the most relevant part, already immediate relevant part is that actually, this data is also relevant for adults. Insomnia is a -- we have a broad indication for insomnia in the U.S. and in Europe. And there are already many millions of patients with ADHD or ASD in the population in the U.S. With that, I will hand back to Jean-Paul with the next slide, Slide 23. To you, Jean-Paul.

Thank you, Martine. Thank you, Alberto. I have to say that I'm really very happy when I see these results because Idorsia went through difficult times, and really, I want to thank all the collaborators, all the Board members, everybody who stayed. Without them, without this perseverance, we would not see today this data which in my mind will -- and you will see after the publication really represents a scientific breakthrough. These results show once again that daridorexant is an outstanding drug and they present a great opportunity for Idorsia. First, the clean safety and tolerability profile in children as young as 10 will undoubtedly strengthen confidence in QUVIVIQ among prescribers treating adults. Second, our continued development in the pediatric population should influence the descheduling process with the FDA and DEA. Third, the unmet medical need in pediatric insomnia is substantial. Millions of children experienced chronic insomnia that profoundly affects daytime functioning, mood and cognitive and physical development. Remember, daridorexant is the only DORA currently being investigated in the pediatric population, positioning it to become not only best-in-class for adults, but potentially first-in-class for children. Finally, the emerging data on neurodevelopmental disorder could unlock an entirely new therapeutic domain for daridorexant beyond insomnia. And we look forward to initiate discussion with health authorities on the data. As soon as we secure presentation at the high-impact congress and scientific publication in a high ranking journal, we can go, and we will go into more detail.

Many thanks, Jean-Paul. With that, Nadia, I think we can open the lines for questions.

[Operator Instructions] And now we are going to take our first question, and it comes to line of am Raghuram Selvaraju from H.C. Wainwright & Co.

Congratulations on this very exciting data. I was wondering if you could provide us with some additional granularity regarding what's the scope and nature of clinical development for a drug like daridorexant might look like, in the context of neurodevelopmental disorders, particularly autism spectrum disorder and how the efficacy endpoints in such a context might change relative to what you would typically use like total sleep time, for example, in the insomnia setting specifically. And also, if you could give us some additional data on how the market opportunity, the total addressable market could change for daridorexant if it were granted an official label some years down the line, for example, in neurodevelopmental disorders, including but not limited to autism spectrum disorder.

Thank you, Ram. Maybe, Alberto, you take the first question, and then we hand over to Jean-Paul for the second question.

Yes, of course. I think as we will -- it's too early to look at what is the development plan that could be in neurodevelopment disorders, autism ADHD. Of course, the main hypothesis is emerging is that, okay, there is no doubt, this is my personal opinion, there is an effect in insomnia in this population. However, the new program will not look at insomnia in patients with neurodevelopment disorder rather potentially bringing the treatment of the disease is what also Martine was alluding to. And in that case, of course, the endpoint will be different compared to what we have now with TST or other measures of insomnia. So we will -- we may target directly the disease. And we have -- basically there are some scales that we can use and can be discussed with the health authorities. There is an EMA guidance, for example, on autism. so I'm not sure that the answer completed the first question. Kevin, tell me if I missed something.

That's fine. Thanks, Alberto. Then we can address the second question, Jean-Paul.

Yes. I think I have some numbers. I'm not speaking about commercial market, but the clinical need. I was turned first in adults. And as Alberto said, these adults today with insomnia can be treated with daridorexant. There is no exclusion from these patients. And I wa stunned done by looking that there are about 15 million adults with attention deficit disorders and about 25 to -- up to 50% of them have insomnia. So 7 million, if you want an average. 7 million of patients with ADHD, adults with insomnia. With intellectual disability or development disorders, 2.3 million adults with 85% prevalence of insomnia. And in autism, it's 5 million adults with autism today, and I would say, from 32% to 72% according to the publication. So about 50%, let's say, as an average, have, insomnia. So this is, frankly, a stunning number in adults. Now in children, of course, and I'm just speaking about the U.S., and I think that you could about -- multiply, have the same numbers in Europe. But focusing on the U.S., there are, in children, 5 million children with attention deficit -- or sorry, with hyperactivity and 25% to 50% of them have insomnia. There is -- there were 9 million children with intellectual disability. And they nearly are -- 90% have insomnia. And autistic children, there are about 2 million children. And I would say a majority of them have insomnia. So you see that -- even if we would take insomnia alone, there is a huge market in the U.S., and this is why I'm focusing on the U.S. number because there is no treatment today. So you see that there is a very big number of adults and children within insomnia, but also, of course, without insomnia. And as we mentioned, now we are going to really evaluate and certainly initiate a program in these patients with MDD. So I hope I answered the question.

I think you're on point, Jean-Paul.

Please, go ahead, Ram?

Yes. Sorry. I Just wanted to point out that as many in the audience may already know, autism spectrum disorder is growing at an unprecedented rate among neurodevelopmental disorders. And by some estimates, has increased by 175% in pediatric patients over the course of the past 2 decades. So I think that's an important thing to note. Two other very quick items I wanted to touch upon, if I may. One is with respect to whether or not you intend to seek additional prosecution of further patent claims around daridorexant to broaden the IP estate based on the observations that were made from the Phase II pediatric insomnia trial. And the other is from a competitive landscape perspective. If we look at the DORA class, and the unique attributes of daridorexant from a safety and tolerability perspective, is it your view and your expectation that because daridorexant seems to be uniquely safe and well tolerated, particularly for use in children as this Phase II trial showed that this might erect a competitive moat around it that will enable it and it alone to be applied in the pediatric setting and in the neurodevelopmental disorder context. Whether or not its ultimate activity lies solely in the domain of improving sleep or extends to other efficacy parameters.

So we -- we certainly have very unique properties by having this optimal pharmacokinetics and the data on -- data and functioning in adults are very, very compelling. And you see now -- you have only a glimpse of the results we are progressively discovering in the pediatric study, but we see this dose-dependent increase or increase at the highest dose, which is quite really surprising both in adults and now in children of an increase in morning alertness. And I think that we have really a perfect profile for children, and the safety and tolerability, which as you have seen are amazing, including a total absence of signs of abuse or withdrawal or addictive signs. So we have really a drug which is really perfectly suited for children and the result in sleep and [indiscernible]. So yes, of course, we are serving and taking care of the protection of the data, absolutely.

Yes. We have worked very actively on protecting this data. Of course, that's something which is key, and we have all the -- we have been active in the coming -- in the last weeks to really protect this new data. What I wanted to say that we had daridorexant, and we knew that we had an active drug, but we did not have the ideal drug. As Martine said, it took us 10 years and 25,000 new drugs in order to discover daridorexant. And it's only because daridorexant has it's unique pharmacokinetic properties, it's unique binding that we can achieve this data. It was really worthwhile to wait 10 years to work so hard for the chemist to get there. And I really believe that without these properties, it will be extremely difficult to go in children, for example, of a very low weight or to avoid the somnolence in the morning because of the pharmacokinetic characteristics that you need to get to this profile.

Maybe -- Alberto here. If I can add 2 words actually, I think in the competitiveness, I think that we have -- given what Jean-Paul and Martine has said, I can just add that from a development perspective, we are the -- in the adults and now it seems to be confirming children that it's the only one with a dose response on efficacy and no dose response on safety. And that can be seen easily in the FDA reviews of the data, and we have done exactly the same analysis with daridorexant that they did for lemborexant, for example. And actually, we were able to demonstrate that we don't have a dose response on safety. That's why they translate clinically the profile that Martine and Jean-Paul were highlighting from a scientific perspective. Sorry, just a comment.

Thank you, Ram, for your comments. Nadia, next question.

And the next question comes line of Joris Zimmermann from Octavian.

Joris Zimmermann from octavian. I have a follow-up question on the regulatory path forward. You mentioned that for the neurodevelopmental disorders, it might be a bit early, but I was wondering if you could share the expected next steps in terms of the general pediatric insomnia patient population? Or if my understanding here is indeed correct that you pursued the 2 indications independently? And if so, what your expectations are around the needed trials, time lines and if possible, already on the costs? And then second question on the potential. I was wondering how do you assess the potential from the pediatric indication versus the potential that you could see from the potential halo into the adult population?

Thank Great. Thanks, Joris. Alberto, do you want to take the first question?

Absolutely. Again, as I mentioned earlier, it's too early. But indeed, the next steps will be to discuss with the health authorities. So for -- and you're right, we may -- we will -- need to pursue general insomnia, and with the data that we have in Phase II, although the data being so good that maybe we can discuss what are the further steps. But certainly, the bottom line is to get an agreement on path forward from both health authorities, with the minimize -- the idea is to minimize the number of patients or studies to be done. And the NDD is completely different -- separate. Again, we are not targeting NDD insomnia in those patients in those children, rather the symptoms or the feature of their disease. And for that, we need to get discussion. Again, there are only -- we are guided only by the guidelines for EMA at this point. And -- but we -- and there is no guideline from the FDA. So again, we need to use certainly specific scales and endpoints that are validated in for autism and then see what kind of studies the authorities request us to do. Again, I didn't answer very [ quick ], and I'm not answering about cost or time lines at this point because it's really too premature.

To answer your question on the repercussion for adults, I think, we have really a duplication or a replication of the amazing efficacy and safety profile in children. We knew daridorexant efficacy and safety at the same doses without dose adaptation in elderly, we are learning progressively that in patients with nocturia, as published, the efficacy on sleep also was replicated. Every time we are reproducing that this children study at the same doses as in adults with the amazing efficacy on sleep, particularly in the neurodevelopmental disorder subgroup are very, very impressive. And for that, I think, yes, it repercussion in the understanding of the potential in [ adult guideline ].

For the halo effect, how do we quantify. It's -- I would not be quantitative, but maybe qualitative. I think that what this data bring, if you can tell to a doctor that the really high dose, the higher dose, which can be -- which is allowed in adults has been given to children of 10 years old without any problem, I think it will convince them that this drug should really be safe in adults, I'm speaking. And really, you know that sleep drugs have always got a negative value because up to now, they had all side effects. So I think it's really going to help the marketing of today daridorexant in adults. But maybe the most important halo effect in adults with neurodevelopmental disorders because I think that when this data will be presented, you will understand why -- frankly, there would be only 1 drug to give to this patient when you see our data, and this is daridorexant. So -- and here, we are completely covered by the present label, both in the U.S. and Europe. So the halo effect for me, the most important is adults with neurodevelopmental disorders.

Thank you, Jean-Paul. Nadia, next question?

And the question comes from line of Sushila Hernandez from [indiscernible] Kempen.

This is [ Samreen ] on for Sushila. Congrats on the results. So first of all, I would like to go a bit more into your -- yes, the market that you were addressing. So how many of these 10% to 30% of U.S. children and adolescents that are impacted by insomnia do you aim to target actually? And which segment in the children -- in that market do you think would benefit the most? And also a bit more on the future. So again, you said the financing is still preliminary, but can you tell us anything on whether the company feels sufficiently financed to conduct an extra study in pediatrics? And could you maybe expand a little on your current capital allocation priorities?

Thanks for the question. Jean-Paul.

I'm just saying that it's a little bit different between Europe and the U.S. for the children, I think that there are a lot of patients with insomnia -- children within insomnia in the U.S. who are treated. And this is not as a big number in Europe. So the market is certainly much bigger in the U.S. And I think that we have not really -- we have just got the results, and I would not be able to guide you on the potential market, but it is very big. And I think that if we consider is in the U.S., it's very big. Of course, neurodevelopmental disorders is also a very big market, but we need to do additional studies. And -- but I really -- when you speak about the cost of this study, first, these studies are just a questionnaire. This is not like many in many studies where you really need a CT scan, MRI, very expensive. Here, it's simple -- it is going to be a simple questionnaire and observation by the doctors, by the parents, by the caregivers. So these are not very expensive studies as you could imagine in other neurological problems. That's number one. The number two, I really hope that this halo effect that everybody believes is going to happen, we'll pay for it.

Nadia, next question.

And the question comes line of Justine Telliez from Kepler Chevron.

Congrats on this promising data. One follow-up question again, please, coming back on the potential program you aim to initiate in NDD patients. Could you please elaborate on how you are thinking about the target population? Would this initially focus on pediatric patient, age 10 and above? Or could we also think about a broader approach over time, potentially extending into adult populations?

Thanks, Justine. Alberto, do you want to take that question?

Yes, of course. I start from the last part. Certainly, we will need at 1 point to do as a line extension potentially to look at adults assuming, we will be successful in the children pediatric population. For looking at the population, I cannot say much. But indeed, we -- one of the things that we are trying to target is really to identify a specific neurodevelopment disorder, not in general disorders, for which we have specific scale, which are agreed by the health authorities. So I would certainly say that at the end of the analysis that we are doing, further analysis that we are doing on the children that we have between ASD and ADHD, 2 neurodevelopment disorder that we have in our study, we will be able to choose 1 and then get -- as Jean-Paul said, not a simple study, never simple study in this disease. But certainly, not in insomnia, but looking at the symptoms and therefore, using questioners. Did I answer your question or...

Yes, yes, you did.

Thanks, Justine. Are there any further questions, Nadia?

There are no further questions for today. I would now like to hand the conference over to the management team for any closing remarks.

Thank you, Nadia. If there are no further questions, we will conclude today's call. Thank you all for joining us today to look at these exciting results. Nadia, please close the lines.

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.