Greetings and welcome to the BioXcel Therapeutics KOL Virtual Roundtable Day. At this time, participants are in listen only mode. You can submit your questions by typing them in the Ask a Question field on the bottom of your screen. It is now my pleasure to introduce Vimal Mehta, CEO. Thank you. You may begin. Thank you, operator. Good afternoon, everyone, and thank you for joining us today. I would like to start by welcoming our participants. We are thankful for your leadership and expertise in the Alzheimer's agitation space, particularly as we focus on the significant and underaddressed challenge of acute agitation episodes in Alzheimer's dementia. Next, I would like to thank our moderator, Anjalee Khemlani, an award-winning journalist who moderated our last panel in December. We are thankful to have her experienced voice be the guide for today's conversation among our distinguished KOLs. There are currently no FDA-approved treatments specifically for acute episodes, leaving a critical gap for patients, caregivers, and clinicians managing these episodes. The need for a treatment specific to acute agitation episodes remain urgent. At BioXcel Therapeutics, we are steadfast in our commitment to advance meaningful innovation in areas of unmet need, such as this one. Our mission is to advance BXCL501 to reach patients and caregivers who currently face limited treatment options. In the previously announced results from a phase III pivotal study of BXCL501 for the acute treatment of agitation in Alzheimer's dementia, BXCL501 was well-tolerated and met its primary efficacy endpoint. Anjalee, I will turn it over to you for the panel. Thank you so much, Vimal. Hello to everyone. Let me take a minute to introduce this wonderful panel. We've got a Dr. George Grossberg, Dr. Anton Porsteinsson, and Dr. Angela Sanford. I'm gonna give you all a minute to quickly introduce yourselves. Let's start off with Dr. Sanford. Hi, my name is Dr. Angela Sanford. I'm a Professor of geriatric medicine at Saint Louis University, and I'm also serving as the Interim Division Director of the Division of Geriatric Medicine. Thank you for having me today. Of course. Welcome aboard. Dr. Porsteinsson? Yeah, good afternoon, good morning, depending on where you are. Anton Porsteinsson. By training, I'm a Geriatric Neuropsychiatrist, but I specifically focus on the care and study of older individuals with dementia, such as Alzheimer's disease. I'm a professor at the University of Rochester School of Medicine. Pleasure to be here. Wonderful. Welcome. Finally, last but not least, Dr. Grossberg. Thank you. George Grossberg. I'm an academic geriatric psychiatrist at Saint Louis University School of Medicine, and I have a new endowed professorship, which is the Dr. Henry and Amelia Nasrallah professorship. I've been in this space, Alzheimer's disease, and specifically, developing new treatments for neuropsychiatric symptoms of Alzheimer's disease like Dr. Porsteinsson for a number of years. I am speaking to you now from one of our teaching nursing homes, which is an environment where obviously, new treatments for particularly acute behaviors are sorely needed. Happy to be here. Welcome. My goodness, you talk about being on the ground level to understand this very important subject. Well, thank you all for joining us. I want to start out with kind of getting our hands wrapped around the acute agitation issue. As we understand it, episodes in Alzheimer's dementia remain significantly underaddressed. It is an issue that affects so many millions of people and their caregivers, and to your point, Dr. Grossberg, as well in care facilities. This is an issue that is, you know, really something that we need to look at. It's something that has no real solution other than basically sedating patients as far as I understand. I'd love to start off with you, Dr. Grossberg, and kind of get our handle around why this conversation is important. What do we need to understand about acute agitation and its, sort of a debilitating impact on care and caregiving? Yeah, no, I think that's a great question. I think most of us when we think about agitation in disorders like Alzheimer's disease, think of it as kind of a chronic persistent problem. Currently, the only FDA-approved medication for agitation in Alzheimer's disease, as well as almost every other drug in the pipeline, except for the one we're gonna be talking about today, focuses on more persistent or chronic agitation. In fact, the International Psychogeriatric Association, the IPA, who have developed the diagnostic criteria for agitation, those criteria call for pretty much persistent day-to-day agitated behaviors that are impacting quality of life for at least two weeks or longer. They don't really address acute agitation, which can occur intermittently, which can occur even during the course of more persistent kind of chronic agitation. Of course, when it happens in the nursing home, like where I'm at right now, often it's a reason why patients are sent to the hospital, to the emergency room. If it happens at home, where the family is taking care of someone who has an acute, aggressive, or agitated behavior, often they're also rushing off to the emergency room. It's a reason for heavy utilization of healthcare resources, and we do not have anything currently that's FDA-approved for the acute agitated episodes. Sanford, maybe you can tell us a little bit about what is currently out there, why it's looked at in terms of a chronic, you know, management situation and how we can think about what defines, you know, chronic versus acute. There are not many FDA-approved medications, really only the one that I know of for even chronic agitation. Acutely we will try anything in the acute setting, not anything, but we have not very good medications that aren't very safe to use in older adults, but we use as last resorts, and that's sort of what we're stuck with in the acute settings. Like Dr. Grossberg, I work in the nursing home, and yesterday I had a patient that was acutely agitated, and the nurse was saying, "I don't know what to do. You know, what can we give her? This is not gonna work out today for us to deal with this." It's a very chronic problem with acute flares, and it can really impact quality of life for patients and caregivers. Dr. Porsteinsson, can you maybe explain to us, you know, how it presents in the acute form and then how it presents maybe more in the chronic form? Absolutely. You know, I wanna make sure we understand that episodic agitation or acute agitation, those are the two terms that we use pretty interchangeably, can happen in any setting. It can happen in a long-term care, so a skilled nursing facility, it can happen in an assisted living facility, and it certainly happens at home in the community. You heard George talk about the diagnostic criteria for agitation according to the IPA criteria. There you're required at least two weeks of relatively frequent occurrence of agitation, and you also want a certain intensity of that agitation. The agitation is one of the most distressing behavioral disruption in Alzheimer's disease as well as other dementias. The episodic agitation is on the other hand, it happens sporadically. It happens episodically. It can happen in someone who doesn't have chronic agitation. Then it can also happen, you know, for someone who has chronic agitation. Now whether you use non-pharmacological interventions or medicines like the one that is approved for that, brexpiprazole, you still can have these kind of breakthrough episodic agitated behaviors. They often are associated with the patient not understanding what's going on, getting overwhelmed and just kind of boiling over, becoming restless. There can also be a verbal aggressiveness, even physical aggressiveness. It can be because someone is uncomfortable. They've got pain. They cannot communicate what's going on. It can be very simply that someone wants to be left alone all the time. You can't do that. You have to provide care. You have to provide attention. It can be personal hygiene. It can be attending to, you know, urinary or bowel needs, et cetera. It creates this blow up. I can give you another example. One of my patients lived with her husband. Their kids, grandkids lived one city over, 45-minute drive. Every time that they thought about visiting the grandkids, the family, just the ride over, she would get so agitated, so restless. Yet whenever she was there, she was happy. It gave her husband a reprieve, allowed them to connect with family. Those are the types of situations where we can have this bubble up. What often will happen is that you stop going out, you stop socializing, you stop seeing family, you stop seeing friends. You don't get the care that you need or should be entitled to because people, be it family caregivers, professional caregivers, have to deal with the intensity of these behaviors. Yeah. It seems like it could be really disruptive, you know, to daily life. Having a solution and one that would be easy for caregivers in addition to be able to, you know, use, is really necessary. I also have started thinking a lot more about how we're sort of in a phase of, you know, having more care needed for an increasingly elderly population. Not only aren't these treatments needed because of, you know, the ongoing need, but also because of volume-wise, there's an opportunity there. Let's break that down a little bit, right? In terms of looking at the population and understanding who benefits the most, what does, you know, a treatment alike, BXCL501 have? What opportunity does it have to help the market, help caregivers, help in facilities, also to help maybe bring down the cost of emergency care as well? Maybe Dr. Grossberg, you can start there. Dr. Grossberg? you can start there. Dr. Grossberg? Okay. I didn't know you were calling on me. I'm sorry. I alluded to some of the issues that you brought up a whole lot of different things. Obviously we know the demographic imperative that the population is aging and that the most rapidly growing segment of our population are older adults. We know that the Alzheimer's population is expected to double or more in the next couple of decades. We have already over 7 million individuals. I think, Anton, as you pointed out, these people are living with Alzheimer's disease in different locations. They may be living at home with family. They may be in memory care or assisted living. They may be in skilled nursing or long-term care, retirement communities. As the numbers of Alzheimer's patients increases, obviously we're seeing more and more of the neuropsychiatric or behavioral problems. The most disturbing and common behavioral problem is what I call the spectrum of agitated behaviors. Everything from irritability to anxiety, to more overtly agitated behavior, to even more overtly aggressive behaviors. When you see the most overt behaviors, including aggressive kind of behaviors, no matter what setting one is in, then you need to take that patient usually to the hospital to find out what's going on. Once they get to the hospital, we use off-label treatments that can make things worse. We use antipsychotic medications like quetiapine and drugs like olanzapine and so on, which can sedate the patient, increase the risk of falls, making it really hard to figure out what's going on. I think, Anton, you pointed out so many of the good triggers of agitation, whether it's pain or infections or environmental changes. There are quite a few things that we need to look at. First you need to get the patient under control, and you need something that's gonna not make them a zombie. That's not gonna sedate them. It's not gonna make them more confused. It's not gonna increase their risk of falls. That's where a compound like dexmedetomidine, BXCL501, that's where it comes in, where it can get the patient under control relatively quickly. Unlike some of the things in the pipeline and the currently approved drug, which you need two weeks to even titrate to an effective dose, it gets them under control in minutes rather than days or weeks. That's what you need, especially in acute agitation situations, whether in the hospital, the emergency room, whether in long-term care, whether at home, whether in memory care, it can be useful in all of those arenas. To emphasize that point from earlier, you know, this is the acute episodes can happen in those who do experience chronic agitation, but also those that don't. Correct? If I'm understanding that correctly. The idea that this could help a very large percentage of the population is imperative. How often do you see breakthrough agitation episodes in patients? That's a question coming from the audience. By the way, audience, you are allowed to send in questions. I will be reading them periodically. Continue. I don't know if it's for me or for any of us, but I'm not sure that we have really good data on relative to that question. I can tell you from an experiential standpoint, and all of us are coming from a little different kind of arenas, we can all comment about that, is that it's not rare. It's actually quite common. Whether it's occurring in isolation in someone who hasn't had the chronic agitated behavior, or whether it's episodic, like you pointed out, Anton, it is very common. Even individuals who may be already on treatment for more chronic, we'll call it, or persistent agitation, there can be this breakthrough kind of agitated or aggressive, whether physical or verbal episode that makes it very hard for the staff or for the family to take care of the individual, and that's when they go to the hospital or reach out for help. I think one of the difficulties is the unpredictability. We shared examples of that. You know, sometimes maybe that patient on the car ride would do okay, and once she got to the family's house was okay. Sometimes it just was very difficult, and you never know the family members and the caregivers, and the patients never know sort of when it's gonna come on. I think the unpredictability makes it so difficult for quality of life. And, and let me-- To that quality. Go ahead. Let me give an example and kind of put it more into maybe the results that we see in clinical trials. For chronic agitation, if we see about a 30% improvement in, you know, frequency and intensity of behaviors, we often say that that's a responder. 50%, we're very happy. That tells you that, you know, there remain about, you know, 50%-70% of the symptoms that are kind of boiling underneath. This can take chronic agitation from being unmanageable to manageable. The medications that we're looking at for chronic agitation, none of them, by the way they work, none of them, it doesn't help to give another pill. "Okay, he's having a bad day today. How about if I give another pill?" Doesn't work. That's not the way that the currently available medication works or the ones that are currently in development. Therefore, we have to have other options. Lot of the medications that are used in the community right now are sedatives. They may have, you know, hours worth of sedation associated with them. Many of them are specifically kind of, you know, advised against in terms of don't overuse these medications for this population. Finding something that works predictably with a relatively rapid onset of action that doesn't kind of-- That makes people tranquil than somnolent, sleepy, sedated. That's appealing. That's appealing to clinicians. The other thing-- I was gonna say, Anton, the other thing that's appealing is not having the box warning. Because, you know, this is not an antipsychotic, and it doesn't have the box warning relative to increased mortality. One of the things I find-- For example, in the nursing home I'm at right now, the primary care doctors who admit here and follow patients here often don't wanna deal with antipsychotics. They don't even wanna prescribe them because of the box warning. They'll refer those people immediately to us. Having a potential treatment that doesn't have that liability, in addition to all the pluses you mentioned, Anton, I think is a good thing. It is important, too, when compared to what's on the market because, you know, we do have that concern of over-medicating, of not being able to treat people correctly. To your point, Dr. Sanford, about the quality of life, I think that's a key part of this conversation, right? We haven't been able to. At a point in time where there are so many folks that are entering the space, we haven't been able to find a solution that is going to help maintain some kind of independent living quality of life. It really does hamper individuals and their ability and puts extra burden on caregivers who aren't able to then put their lives in active mode. They have to constantly be watching out for episodes, to your point even, you know, hiding and staying away. Is it? The first part of the question is this eases the burden for caregivers and caretakers and clinicians. Is there any possibility in this situation for self-administration, or is it, you know, not an option because individuals who are going through the episodes can't really, you know, don't really realize they're in the middle of it? I don't know who wants to take that. Let me just kind of give a quick perspective from my end. Clearly we're using oral medications in most of these situations. There are occasionally in the hospital or even possibly in the nursing home that we may have behaviors that are so intense that you need to. People are so unwilling to or unable to kind of help with the taking medication, et cetera, that you might need to use an IM or a melt away or something like that. In most situations, you know, people are distressed, they're upset, but they often seek some sort of solution to this as well. This is not just distressing to family caregivers or professional caregivers. These are behaviors and actions that are often very distressing to the patients. They seek some sort of a solution, some sort of a solace. You do need to kind of work with people if you have someone who has moderate or more advanced dementia. How do you take a thin film? It's a medication where the active compound is kind of built into this thin film that you put on the mucosa in the mouth. With that, you have a pretty quick and reliable absorption. That, that is an issue. It. You know, clearly there's not gonna be 100% success rate with that. Targeting people in the earlier clinical trials, there was a pretty good success rate even with patients that had moderate to advanced dementia living in skilled nursing facilities. It's doable. It's absolutely doable. So I still see it as a viable delivery system. I interpreted your question differently. All right. I interpreted your question as asking about whether this population could self-medicate, and generally the answer is no. It's really almost unheard of that I would have an Alzheimer's patient come to me when they come to clinic or in the nursing home saying, "Doc, I need help with my agitation. What do you recommend?" We're almost always depending on the family, on the professional carers in the long-term care environment to really tune us into what the problem is and that there is a problem, and we're making a decision for the patient about what's best. Yes, I agree, Anton, that, you know, it's easier when you have a film. You could put it anywhere in the mouth. A lot of these patients might spit out a pill if you put a pill in their mouth, if you don't have that rapid absorption. Generally, the format that this drug is available in, I think would have pretty high adherence. That's good to know because the, one of the incoming questions is thinking about safety. I know we mentioned or we were discussing earlier, you know, it's not going to be like other medications where you have, maybe an overdosing problem or not, you know, over-utilizing. Does this also have that concern? You know, how do you think about that in terms of, an at-home setting, the use of in an at-home setting? I think there are plans to do an at-home study, and I think that will be useful and very important. I think in some data that the company that I've seen has previously, it seems like the compound can be administered maybe three or more times, even during the day, spaced out over time without additional deleterious side effects. I think we need probably more information about specifically, you know, we know about the half-life, but how often it can be given within a 24-hour or any given kind of timeframe. I think that's gonna be very important, particularly in the home, where a non-professional person is making the judgment about when to give and how often to give. Yeah. Do you think that there is any concern about general dosing safety? You know, considering what we see with sedatives and the like, is this the type of medication, because it's a episodic situation, do you think that there needs to be, or based on any of the data that you've already seen, that there's any discussion that needs to be had around what, if there is potential of overdosing? You know, if you look at the data for dexmedetomidine, I think it is important to understand that this is a medicine that has been used particularly in ICU settings and for multiple years. It's given, you know, via injection. This is a way to use the same medication that, you know, doctors in those settings are actually quite comfortable with using without, you know, injecting someone. If we look at the side effects in the TRANQUILITY II study, then basically slight somnolence, so in the kind of mild to moderate range was the most common in about 15% of participants. Lethargy was extremely rare. You had kind of some somnolence, but the highest state of that, which we would refer to as lethargy, that was very rare. That was, you know, in kind of the low single digits. You got to be thoughtful about the anything that kind of sedates people, and if you think about how this drug works, it does that by kind of tuning down the norepinephrine system. With that, there are gonna be some people that might have a slight drop in their blood pressure. That was also kind of seen at about 15%, and also usually in the mild range of severity. We're not seeing in the clinical trials a lot of incidents where someone had to be, you know, attended to or taken to the hospital or something like that because they had a significant reaction to a single dose. Yeah. Go ahead. Yeah, I was gonna say I agree with that. I think the example you cited, Anton, of this drug having been used and being used even currently in its intravenous form in the ICU in older people with multiple major cardiovascular and other serious medical problems, and having confidence in this drug that it's not going to snow the patient, it's not going to exacerbate other acute serious medical problems that are serious enough to have them wind up in intensive care, gives you a great deal of comfort. It gives me a great deal of comfort. It's not a new drug. It's something that we know, albeit in a little bit of a different form. The administration of this, is it something that would be needed just as needed? I know we mentioned there's a difference in the patient population between those that already have chronic and those that don't. In the chronic population, is it seen as sort of a in tandem, you can give a patient who's on chronic meds also this, or will that need additional studies? Well, I mean, it's used that way in the intensive care unit in its intravenous form. I do think that we might need additional data. Let's say, for example, someone is on brexpiprazole, which is the FDA-approved drug for chronic agitation, and they have breakthrough anxiety. I wouldn't have any hesitation in recommending, you know, the oral film version of this drug for those acute episodes 'cause there's no indication there would be any adverse interaction or significant side effects when both are on board, although that hasn't been specifically studied as far as I know. What do you see as sort of the biggest challenge in addressing this population in, being able to identify, you know, the right moments to administer and the like? How should we be thinking about, how to think about this drug once it reaches commercialization, you know, and is on the market? Anyone? Any takers? We can skip over that one. Oh, no, I mean-- Go ahead, Anton. Sorry. I, well, George, you take that one. Yeah. Maybe you can put your question in more of a nutshell. I mean, I hear you asking about, let's say, this drug does get FDA approval and becomes commercialized, how it's going to be utilized. Is that what you're asking? How it's gonna be utilized, and are there any challenges you foresee? Well, I mean, cost is always a challenge. A ny new medication and trying to get insurance reimbursement. Otherwise, I think with its really good profile, ease of administration, not having to worry about the patient kind of spitting pills up and so on, I think it would be relatively easy to use and would have high adherence. I don't see any particular problems. A few of the things for me would be basically it's novel. It's different. Anything that's different is, you know, has a little bit of-- You have to kind of explain to people, "Okay, this medication doesn't come in a pill. It comes in this film." You have to explain to people why the film can be appealing. You have actually basically placebo films that you can work with teaching people to use, they get a sense of comfort. I saw one of the question in the list of questions sent in. How quickly does this, you know, bring about the benefit? I think that it's important to understand that you see, you know, behavior start to kind of drop in 30 minutes. In 60 minutes, it's considerably lower and a split between drug and placebo. The big issue is that then events where we have someone go completely off the rocker, those happen, but they're relatively rare. When you have something that is that intense, be it at home or in a skilled nursing facility or assisted living, those are the situations where someone appropriately might need to go to the emergency room if they can't be safely managed at home. There are so many kind of incidents that are somewhere kind of in the middle. You can't just work with them non-pharmacologically, distract them, offer them ice cream, whatever you do. It's not enough. That's those kind of right-sized events are pretty common. They are often situational. Like I said, you can kind of have a sense when they are more likely to happen around personal care, around, you know, you needing to go to the doctor or maybe a right, you know, to visit family. You work around the-- that. I saw another question. Well, what about if someone is so angry, so agitated, would you stick a finger in their mouth? No. I mean, there are gonna be situations where you hopefully will use good judgment. It is remarkable, you know, what we ask of professional and family caregivers and what they can manage. You know, these are not wallflowers. They handle situations that I would not wanna be in on a day-to-day basis. Here we offer them an additional tool that may help with kind of keeping someone out of the, you know, most intense settings. You know, it's really hard to take someone to the emergency room, to urgent care. It's disruptive for everyone involved, the professional setting as well as the home setting. We want to avoid that. Nobody benefits really from going to the emergency room. That's really just a safety issue, or a last resort because you can't handle it better. In terms of the sublingual administration, I also worry about when staff members have to use an injection. You know, when the person's acutely agitated and you're coming at someone with a needle, that doesn't seem very safe. I almost would prefer the sublingual route than, "Here, take a needle and go inject this in this person who's flailing about." I think we're asking a lot when we ask people to do that. It's a really good point. It does help with the safety. Yes, Dr. Grossberg. There's other. We have other products that have been on the market for a long time that are commonly utilized. We have olanzapine comes in an oral film, risperidone comes in an oral film, and those have often been used. I was going to ask, you know, how does it compare delivering this oral route versus, some of the other drugs that are on the market, to your point of having to teach, you know, individuals that this is a film. It seems like that is fairly novel, but not hard to do necessarily, at all. Dr. Grossberg agrees. It's an easy sell. You know, we talk. One of the medications I use, not for this indication, is a transdermal patch. I think that's a lot more complicated than this as to where it goes, where it shouldn't go, how you change it, make sure there isn't too much hair underneath it. That's much more complicated. People are okay with that. I think this is a really easy sell. That's a fair point. Or dealing with, the skin irritation from the topical patches. You know, how much you need to kind of teach people to wipe off any adhesive residue, et cetera, et cetera. Right. You know, we work with this. Seems like this is going to be able to answer a lot of questions and save a lot of folks' time. You've also clearly defined kind of who this potential market is. I'll give it back to you guys to kind of share, you know, any final thoughts on sort of what you see as the potential market, the sort of benefit of this drug in its form, in its oral form. We'll just go round robin. Dr. Sanford, we can start with you. I work across the geriatric care continuum, so in the outpatient setting, in my clinic setting, I see it as a way for caregivers to keep people in the home longer before institutionalization. I also work in assisted living and memory care. Same with that care setting. You know, everyone's dreaded thing in life is going to the nursing home. No one wants to go to the nursing home. I see this as a way to be able to help people live independently with their caregivers in the less restrictive care settings for as long as possible. Fair. Dr. Porsteinsson? For me, I think the big issue is that the medications that I'm kind of forced to use currently, those could be the atypical antipsychotics, the more sedating ones, or benzodiazepines. They often have an impact of, you know, that could be short to six hours, but it could be a 12-hour tranquilization, pretty high side effect burden. I'd like something that is less likely to cause a problem, where the kind of onset of action is fairly well prescribed, the absorption is reliable, and the duration of effect is reasonable. For the situations that I mentioned before, where there are episodic agitated events that you can't deal with otherwise, this is gonna be helpful. That's where I want to use this for example, the rites, the flights, the oppositional behaviors around personal care that doesn't necessarily have to happen every day, but you also can't do that every two weeks. I mean, you will need to kind of make sure that you're meeting the needs of the patients. Ultimately, that's gonna reduce caregiver burden. I think Angela put it very well, you know, reduce the need to kind of push up to a higher level of care. Dr. Grossberg? Yeah. It occurred to me that there are other arenas where a drug such as this in its current format may be useful. Just this past week, I got a call from one of our residents who was seeing patients on the consult service of our big teaching hospital. It was an older woman in her 80s who was on internal medicine, who was clearly delirious. Delirium is an acute confusional episode. I think she maybe had some baseline dementia, but I'm not sure. Now she was very confused, very disoriented, and very agitated. They needed to find out what the cause of this acute confusion and disorientation, which was triggering the physical agitation and aggressive behaviors, was all about. They wanted to give her something that wasn't going to knock her out, wasn't going to be heavily sedating, was not going to even further maybe impair her cognition, and so on. BXCL501 or dexmedetomidine becomes a really good choice because it can give you relatively quickly, not in hours or days or weeks, but, you know, usually within, let's say, 60 minutes or 90 minutes, pretty good control of the patient without really contaminating things with sedation or other impacts on the cardiovascular system, without making them more foggy or more confused cognitively, giving us an opportunity to evaluate them and see what the trigger might be for this delirium, the acute confusion and disorientation. I think it has a major role there. It might be used off-label, but that's okay as long as we know that it's safe and well-tolerated. Yeah, that's a really good point. Well, thank you so much for your insights. Really helpful in sort of explaining what we're dealing with here and the market potential for this. Thank you so much for your thoughts. Thank you. Back to you, Vimal. Thank you, Anjalee, for guiding today's discussion, and thank you to Dr. Sanford, Dr. Grossberg, and Dr. Porsteinsson for sharing your expertise and perspective. We are also grateful to everyone who joined us and contributed their attention to this important topic. Today's conversation confirmed the importance of acute agitation in Alzheimer's dementia and the clear gap that persists in treating these sudden episodic events. Patients, caregivers, and clinicians are still without an FDA-approved option specifically designed for acute episodes. Advancing solutions that are specific for these episodes remain an essential priority for us at BioXcel Therapeutics. We appreciate your participation and look forward to continued progress in addressing this critical area of need. Thank you again.