day and thank you for standing by. Welcome to the Idorsia Pharmaceuticals daridorexant pediatric insomnia results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star one one on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our 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 result 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. 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 disorder, potentially opening an entirely new therapeutic avenue for this situation. 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 the dual orexin receptor antagonist, which we call DORA, induce sleep and a very good quality of sleep. Now we know that insomnia is characterized by an overactive wake signaling, and that DORAs are a very good way of treating insomnia to inhibit the overactive wake signal by blocking the two orexin receptors instead of depressing the brain to induce artificial sleep as most older drugs in insomnia were doing. Next slide, please. Not all antagonists of the orexin system are created equal. We have worked relentlessly, even stopping the development of our first DORA, suvorexant, to arrive at the optimal molecule. As Jean-Paul was telling, after 25 years of research, more than 25,000 molecules designed and synthesized after suvorexant, and guided by the revolutionary work of computer modeling, we achieved what we were aiming for in our drug discovery endeavor. An antagonist of both orexin 1 and orexin 2 receptors, blocking both receptors with equal potency, with a rapid onset of action and a duration of action long enough to cover the night, but short enough to be devoid of carryover effect even at the optimal dose for sleep. Thus, the best possible profile for a sleep drug. By that research goal, we wanted to avoid the pitfalls of molecules for insomnia with suboptimal and too long pharmacokinetics, giving either the risk of carryover somnolence in the morning or a suboptimal efficacy when trying to avoid the disturbing risk of morning and daytime somnolence 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 with, on average, one hour more of sleep per night, improving both sleep induction and the maintenance of sleep, giving also a better quality of sleep, a restoration of a physiological sleep pattern with, in particular, more REM sleep. Daridorexant works in all periods of the night with the largest efficacy in the fourth quarter of the night. Next slide, please. 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 mg 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 mg. Next slide. I believe that the better night sleep in combination with no residual somnolence and the equilibrated antagonism of both orexin receptor is why 50 mg also improves the daytime functioning so well. Using the Insomnia Daytime Symptoms and Impacts Questionnaire, the so-called [IDSIQ], we found that QUVIVIQ 50 mgs improved all three domains, sleepiness, alert cognition, and mood, and all 14 questions of those domains with an increasing effect over time. This makes QUVIVIQ the only therapy to demonstrate significant improvement in daytime 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 affects 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 a program in children with the DORA. Given the daridorexant properties that Martine has just described, we actually were very eager to negotiate the program with health authorities, and we did it with FDA and PDCO, with the EMA. First of all, let me thank the investigators, together with the children, the caregivers, who invested time to advance the science. I have to say that their time and effort was eventually very well worth it. Next slide 13. In this slide, you see the study design. It's a double-blind, placebo-controlled, dose-finding study where children were randomized to three doses. Please note, these are the same doses studied in adult: 10 mg, 25 mg, and 50 mg. The children, the parents, had the burden of spending three nights, two were screening and one on day one, at the sleep lab to undergo polysomnography, from which the primary endpoint was derived. This is an important feature of the study is polysomnography and three 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 is baseline, two nights in sleep lab. Day 1, there is a sleep lab again. 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. They wanted to minimize the risk of missed data points by getting the primary endpoint as early as possible during treatment. Actually, this was probably driven by the experience they had with previous studies. Indeed, in our study, we have only one 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, indeed, they liked the drug because they continued to stay in the study. Next slide, please. Slide 14. As mentioned, the primary objective was the evaluation of the total sleep time by polysomnography. Again, the study investigated three different doses, and the main point is the evaluation of the dose response instead of the pairwise comparison to placebo. The study was sized to show dose response. Next slide 15. 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 fact, that include patients or children with neurodevelopmental disorders, as well as children without comorbidities. This was done to accommodate both EMA and FDA. In the middle, there's also a group of patients with subthreshold ADHD and ASD, which means that they were not diagnosed, but at screening we have tools, a recognized tool to screen for symptoms and signs of ADHD and ASD, and they did not meet the formal definition. Eventually, we were able to agree with both FDA and PDCO that those response was evaluated on the overall mixed population. Next slide 16. You see the demographic characteristics in this slide. Interestingly, there was 20% of children down to the ages of 10 and 11, which in my opinion, honestly is a great achievement by the study team considering an investigator had to convince the parents, the child, the caregivers and the children to stay in the sleep lab for three 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 men. The body weight is represented at the bottom of the slide, and you see that is as expected in this population. 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 kg 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 17. Baseline disease characteristics. The average time from diagnosis of insomnia was approximately four years. You see the three characteristic that define insomnia, and they are difficult to get to sleep and maintaining sleep during night that were reported basically by all children. Actually, early morning awakening was a little bit less represented. The most important feature of this slide for me is the fact that, as mentioned, we had already 30% of children with a diagnosis of autism spectrum disorder and ADHD, attention deficit hyperactivity disorder. On top of this 30%, there was an additional 20% with subthreshold ADHD and ASD, meaning children with feature symptoms but didn't meet the diagnostic. Next slide 18. I'm happy and proud to share that the study was successful and highly statistically significant. The response was observed. You see the p-value over there. In this study, again, it's the first regulatory study with DORA in children. Importantly, the difference versus placebo at the high dose, the 50 mg high dose, was even nominally statistically significant different from placebo. Again, this was not a requirement of the study, but the effects was so strong that we had also a statistical significance there. Further, the effect was particularly impressive. Actually, I would say I haven't seen it earlier on, with unprecedented increase in TST versus placebo in children with neurodevelopmental disorders. Of course, this is, we should still be cautious because this is a dose-finding study. Really the results you will see when we republish are impressive. Let me say that there are still so many data that we need to analyze and properly interpreted that we cannot say more. 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 neurodevelopmental disorder that actually surprise 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 a potential impact on the disease itself and not just on insomnia. Next slide 19. This, for the moment, what 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. 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 28kg-30 kg. Even the highest dose, 50 mg, was well-tolerated. Actually, there is no dose-response on any adverse event. On any adverse events, but also similar to what we are observing in adults, also on events of special interest, such as excessive daytime sleepiness, suicidality, or drug abuse potential, all adjudicated blindly by an independent panel. The point here, why we adjudicate some events by a panel, because we don't want to miss any signal. Here again, it shows and makes it robust to the fact that we do not see any dose-response on any of these events, and especially no event at all in most of these categories, including drug abuse. Next 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 the adverse event reported by the children. You see all the adverse event reporting population are in one table, which is quite exceptional. I'm referring to what Martine said earlier on. We have very few adverse event, one to three patients across group, including placebo with somnolence and fatigue, which is what we usually review when we look at the data in summary. Again, here, no dose-response. Eventually, the great tolerability and safety profile observed in adults seems confirming children. Again, of the same exact adverse events. Next slide 21. You have seen earlier the morning sleepiness or actually the name is not really reflecting what is measured. Actually, it's morning alertness reporting in adult population. Here we show the similar measure in children. Again, the green bar is daridorexant on the top of dose, and the blue is placebo. On top you see the baseline, and you see at Week 2, after only two weeks, you observe that an increase in versus baseline of daridorexant 50 mg 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. You see the scale from zero goes from extremely tired to 100, very refreshed. Next slide 22, which is going to be my last slide. With this data, what are the next steps? First of all, I'm looking forward to discussing this data with the health authorities, the PDCO 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, a PIP 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 four years to 10 years. This is what is summarized on the left of the slide. Equally, actually, and really more exciting, we need to fully evaluate the surprising results that we see in NDD, neurodevelopmental disorder subgroups, and then discuss with health authorities about a potential program for children with NDDs beyond the treatment on insomnia. Maybe here, the most relevant part, already immediately relevant part, is that actually this data is also relevant for adults. Insomnia is. 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 23. To you, Jean-Paul. Thank you, Martine. Thank you, Alberto. I have to say that I am really very happy when I see these results because, you know, 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 represent 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 experience 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. We look forward to initiate discussion with health authorities on the data. As soon as we secure presentation at a 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. Thank you so much, dear participants. As a reminder, if you would like to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star one and one again. Please stand by while we compile the Q&A roster. This will take a few moments. Now we're gonna take our first question, and it comes to the line of Raghuram Selvaraju from H.C. Wainwright & Co. Your line is open. Please ask your question. Thank you so much for taking my questions, and congratulations on this very exciting data. I was wondering if you could provide us with some additional granularity regarding what 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. 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, you know, some years down the line, for example, in neurodevelopmental disorders, including but not limited to autism spectrum disorder. Thank you. 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 it's too early to look at what is the development plan that could be in neurodevelopmental 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 neurodevelopmental disorder, rather potentially bringing the treatment of the disease is what also Martine was alluding to. In that case, of course, the endpoint will be different compared to what we have now with TST or other measures of insomnia. We may target directly the disease. We have basically there's some scales that we can use and can be discussed with the health authorities. There is an EMA guidance, for example, on autism. I'm not sure that I answered completely the first question. Kevin, tell me if I missed something. I think that's fine. Thanks, Alberto. We can address the second question, Jean-Paul. Yeah. I think I have some numbers. I'm not speaking about commercial market, but the clinical need. I was trained first in adults. As Alberto said, these adults today with insomnia can be treated with daridorexant. There is no exclusion for these patients. I was stunned to learn that there are about 50 million adults with attention deficit disorders, and about 25%-50% of them have insomnia. 7 million, if you want, an average, of patients with ADHD, adults with insomnia. With intellectual disability or developmental disorders, 2.3 million adults with 85% prevalence of insomnia. In autism, it's 5 million adults with autism today, and I would say from 32%-72% according to the publication, so about 50%, let's say as an average, have insomnia. 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. I have the same numbers in Europe. Focusing on the U.S., there are in children, 5 million children with hyperactivity, and 25%-50% of them have insomnia. There were 9 million children with intellectual disability, and they nearly are 90% have insomnia. Autistic children, there are about 2 million children, and I would say a majority of them have insomnia. 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. You see that there is a very big number of adults and children with insomnia, but also, of course, without insomnia. As we mentioned, we are going to really evaluate and certainly initiate a program in these patients with NDD. I hope I answered the question. Yes. I would just point out. Thank you, Ram. Thank you, Paul. Please. Just go ahead, Ram. Yeah, 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 two decades. 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 this phase II pediatric insomnia trial. 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 youth and children, as this phase II trial showed, that this might erect a competitive moat around it that would enable it and it alone to be applied in the pediatric setting and in the neurodevelopmental disorder context? You know, whether or not its ultimate activity lies solely in the domain of improving sleep or extends to other efficacy parameters. We certainly have very, very unique properties by having this optimal pharmacokinetics and the data on daytime functioning in adults are very, very compelling. 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 at the highest dose, which is quite really surprising, both in adults and now in children, of an increase in morning alertness. I think that we have really a perfect profile for children, on... The safety and tolerability, which as you have seen, are amazing, including a total absence of signs of abuse or withdrawal or addictive signs. We have really a drug which is really perfectly suited for children and the result in sleep. Yeah, yeah. Yes, of course, we are observing and taking care of the protection of the data. Absolutely. Yeah. So we have worked very actively on protecting this data. Of course, that's something which is key, and we have been active in the last weeks to really protect this new data. What I wanted to say that we had almorexant and we knew that we had an active drug, but we didn't have the ideal drug. As Martine said, it took us 10 years and 25,000 new drugs in order to discover daridorexant. It's only because daridorexant has this unique pharmacokinetic properties, this 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. 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. Thank you so much. If I can add a word, two words actually. I think in the competitiveness, I think that we have given what Jean-Paul and Martine have said, I can just add that from a development perspective, we are the DORA in adults, and now it seems to be confirmed in children, that is the only one with a dose-response on efficacy and no dose-response on safety. 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. Actually, we were able to demonstrate that we don't have a dose-response on safety. That's to translate clinically the profile that Martine and Jean-Paul were highlighting from a scientific perspective. Sorry. Just a comment. Thank you so much. Thank you, Ram, for your comments. Nadia, next question. Yes, of course. Now we're going to take our next question. The next question comes from the line of Joris Zimmermann from Octavian. Your line is open. Please ask your question. Hi, everyone. Thank you so much for taking my question. 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 pursue the two indications independently, and if so, what your expectations are around the needed trials, timelines and, if possible, already on the costs. 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 a potential halo into the adult population? Thank you so much. 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. You're right, we need to pursue general insomnia with the data we have in phase II, although the data being so good that maybe, we can discuss what are the further steps. Certainly the bottom line is to get an agreement on path forward from both health authorities. The idea is to minimize the number of patients or studies to be done. The NDD is completely different, separate. Again, we are not targeting NDD insomnia in those patients, in those children, rather the symptoms or the future of their disease. For that, we need to get a discussion. Again, we are guided only by the guidelines for EMA at this point. There is no guideline from the FDA. Again, we need to use certainly specific scales and then points 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 clear, and I'm not answering about costs or timelines 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 in elderly and safety at the same doses without dosage 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 in this children's study at the same doses as in adults with the amazing efficacy on sleep, particularly in the neurodevelopmental disorder subgroup, are very impressive. For that, I think yes, it can have a repercussion in the understanding of the potential in adult insomnia. Great. Thank you. Jean-Paul, anything to add? For the halo effect, how do we quantify? I would not be quantitative, but maybe qualitative. I think that what this data bring, you know, if you can tell to a doctor that the really high dose, the higher dose, which is allowed in adults, has been given to children 10 years old without any problem, I think it will convince them that this drug should really be safe in adults, I'm speaking. You know, really, you know that sleep drugs have always got a negative halo because up to now they had all side effects. I think it's really going to help the marketing of daridorexant today in adults. Maybe the most important halo effect is in adults with neurodevelopmental disorders. Because I think that when this data will be presented, you will understand why, frankly, there would be only one drug to give to these patients, when you see our data, and this is daridorexant. Here we are completely covered by the present label both in the U.S. and Europe. The halo effect for me, the most important is adults with neurodevelopmental disorders. Thank you, Jean-Paul. Nadia, next question. Yes, of course. Now we're going to take our next question. The question comes from the line of Sushila Hernandez from Van Lanschot Kempen. Your line is open. Please ask your question. Hi. This is Sandrine on for Sushila. Thank you for taking our questions, and congrats on the results. First of all, I would like to go a bit more into your target markets that you were addressing. How many of these 10%-30% of U.S. children and adolescents that are impacted by insomnia do you aim to target actually? And which segment in that children in that market do you think would benefit the most? And also a bit more on the future. 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 priority? Thanks for the question. Jean-Paul? Oh, I'm just saying that, you know, 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 with insomnia in the U.S. who are treated. This is not as a big number in Europe, so the market is certainly much bigger in the U.S. I think that we have just got the results, and I would not be able to guide you onto a potential market. But this is very big, and I think that if we consider insomnia 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. I really, when you speak about the cost of this study, first, you know, these studies are just a questionnaire. This is not like in many studies where you really need a CT scan, an MRI, very expensive. Here, it is going to be a simple questionnaire and observation by the doctors, by the parents, by the caregivers. 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 will pay for it. Thanks. Nadia, next question. Yes, of course. Now we're going to take our next question. The question comes from the line of Justine Tellier from Kepler Cheuvreux. Your line is open, please ask the question. Thank you. Hi, all, and thank you for taking my question, and 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 aged 10 and above, or could we also think about a broader approach over time, potentially extending into adult populations? Thank you. Thanks, Justine. Alberto, do you want- Yep. to take that question? Yeah, of course. I start from the last part. Certainly, we will need at one point to do a line extension, potentially to look at adults, assuming we will be successful in the pediatric population. For looking at the population, I cannot say much, but indeed one of the things that we are trying to target is really to identify a specific neurodevelopmental disorder, not in general disorders, for which we have specific scale which are agreed by the health authorities. 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, the two neurodevelopmental disorders that we have in our study, we will be able to choose one and then, as Jean-Paul said, not a simple study, never a simple study in this disease, but certainly not in insomnia, but looking at the symptoms and therefore using questionnaires. Did I answer your question or? Yes. Yes, you did. Thank you. Okay. You're welcome. Thank you. Thank you. Thanks, Alberto. 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.