Greetings, and welcome to the BioXcel Therapeutics webcast. At this time, all participants are in a listen-only mode. You can submit questions at any time by typing your question in the Ask a Question field on your screen. It is now my pleasure to introduce Vimal Mehta, Chief Executive Officer and Founder of BioXcel Therapeutics. Thank you. You may begin. Thank you, operator. Good afternoon, everyone, and thank you for joining us today. We appreciate your time and interest as we share an update on the commercial strategy and launch plan for IGALMI ahead of its potential approval for the treatment of acute agitation episodes associated with bipolar disorders and schizophrenia in the home setting. As you all know, these episodes represent a frequent and challenging reality for patients and caregivers, often occurring outside of clinical settings where there are currently no FDA-approved therapies. We are entering a key period for BioXcel Therapeutics as we prepare for the upcoming November 14th PDUFA target action date for IGALMI. At this time, our focus remains on executing our launch readiness activities to ensure we are well-positioned to bring this treatment to patients and caregivers as efficiently as possible, if approved. Finally, I would like to thank our Interim Chief Commercial Officer, Mark Pavao, who has been instrumental in developing the launch plan and commercial strategy for IGALMI, and our moderator, Michael King, for leading today's event. With that, I will turn it over to Michael King. Thanks, Vimal, and good afternoon, everybody. It's nice to join you today. I'm delighted to have been asked to moderate the Q&A session of this event, which I hope will illuminate the significant opportunity for IGALMI for at-home use and, in conjunction with that, of course, with BioXcel stock. In the interest of disclosure, before I introduce Mark Pavao, I would like to just read the following disclosures. First, BioXcel is an investment banking client of Rodman & Renshaw. Number two, we cover the stock, which is rated buy, and we've established a $17 price target for the shares. Finally, neither I nor any member of my household owns shares in the company. With that, let me introduce Mark Pavao. Mark Pavao has more than 30 years of U.S. and global commercial leadership experience across the biopharma industry, including extensive pre-launch planning and on-market commercialization in CNS and additional therapeutic areas. He has contributed to the commercialization of multiple CNS therapies, including Abilify for schizophrenia, bipolar disorder, and depression, Paxil for depression, Risperdal for schizophrenia, and Nurtec ODT for migraines. I would just add editorially that the parallels here are very strong. Without further ado, let me let Mark launch into his presentation, and we will come back at the end with a Q&A. Mark, over to you. All right. Now can you hear me? Am I coming through? Yes, go ahead, sir. Okay. Yes, Mark. Sorry about that. I was muted. Michael, thank you very much, and I'm excited about the opportunity to share the IGALMI at-home opportunity from a commercial perspective and talk about what we've learned from our market research, as well as how we're thinking about the go-to-market plans for IGALMI. Let me start off by setting the stage by reminding us where IGALMI has come from and where we're going. IGALMI was approved back in 2022 for use specifically in the institutional setting with administration under healthcare supervision. Fast-forward to last year, the SERENITY At-Home study demonstrated that IGALMI can be used successfully at home by patients administering it to themselves without medical supervision. That data has now been filed through an sNDA. sNDA was accepted for review. We have a PDUFA date of November 14th and are looking forward to launching in first quarter of 2027. As you will see as we go through the story, the market opportunity expands significantly from the institutional setting to the at-home setting. More importantly than that, the value proposition completely changes. In the institutional setting, there are other medicines indicated for the treatment of acute agitation. In the at-home setting, nothing is indicated. Further, the goal in the institutional setting is to calm patients down who have presented to the ER. The goal in the at-home setting is to help patients deescalate so they don't end up in the ER. Very different value proposition in the at-home setting. I'm going to walk through a couple of slides that summarizes what we've learned in the market research that we've done. First, we've talked to physicians, we've talked to patients, we've talked to payers, and what's come through about the condition itself, acute agitation in the at-home setting, it happens frequently, it happens often. 36% of bipolar patients who are well-controlled on their underlying mood stabilizers, 50% of schizophrenia patients who are well-controlled on their underlying antipsychotics, experience breakthrough agitation. Which can be distressing, disabling, and if it escalates, can lead to those hospitalizations or worse. The symptoms span a range of areas from emotional symptoms like tension and irritability, behavioral symptoms like restlessness and overactivity, cognitive symptoms like impulsivity, and despite all of this, nothing is indicated to treat acute agitation in the at-home setting. The market opportunity is very large, and the IGALMI profile is very, very strongly fit with the unmet need. As we talk about the opportunity itself, agitation at home is under-recognized and under-treated. I say that, the analogy is the tree that falls in the woods. If you're not there, you don't hear it. Physicians know that patients get agitated. They're very aware of the patients who are agitated at home who end up in the ER. They are less aware of how frequently and how often patients are agitated on their own. They do know that it happens. When they do treat patients at home, they're basically doubling down on typical or atypical antipsychotics, oral antipsychotics, which are slow to act, or benzos, which are controlled substances and have other issues. Physicians recognize that the current treatments are not optimal. When they see the IGALMI profile for at-home use, they're very excited and they project that IGALMI will be used in 70% of their appropriate schizophrenia, bipolar patients who experience agitation in the at-home setting. We've talked to patients, all of whom have experienced what it's like to be in the ER and be treated in the ER and be calmed down with either injectable antipsychotic or an injectable benzo. Those experiences are not pleasant. When we talk to patients and we present them with the TPP, the target product profile for IGALMI at Home, very, very high interest. They project that they would use this in 80% of their future episodes. We also talked to payers in our market research to understand how they would think about placing IGALMI on formulary. The consensus was, we talked to five payers, these were payers that represented very large health plans. The consensus was that because nothing is indicated, because this is an unmet need, because appropriate treatment that avoids the escalation and an ER visit or hospitalization, that IGALMI will be covered on formulary with common restrictions such as prior authorization to label. Making sure that only patients who have an indication for schizophrenia, bipolar, get the medicine, and potentially quantity limits as well, since this is not a medicine indicated for chronic use, but it's a medicine indicated for episodic use. Moving along in the research, we also were able to dimensionalize the size of the opportunity. In our research, we were able to calculate that there's 2.3 million treated bipolar and schizophrenia patients who have frequent acute agitation. Frequent in the research was defined as 10 to 15 episodes per year. Of those treated patients who have episodes, when you map out the number of episodes they have, which is about four per month, that adds up to an addressable population of about 86 million episodes per year. When you think about this in the context of the 16 million episodes per year that are seen in the institutional setting, you understand that this represents a significant expansion of the addressable market available to IGALMI as we move forward and secure this indication and take it to market. Mark, can I just ask a quick question about this slide? Sure, of course. Yeah. Why do you think the hospital setting is so much smaller? Those numbers are significant as far as the number of episodes. Is it because patients never get to the ER? Are they reluctant to go to the ER? Are they treated elsewhere? What explains that dichotomy? Yeah, I think it's a couple of things. First, we know the patients are reluctant to go to the ER. They've been there before. It's not a pleasant experience. So they will avoid it if possible. Secondly, I think patients are largely, they're suffering in place. They're experiencing distress that's ruining their day. They're becoming uncooperative or perhaps belligerent in whatever work setting or home setting that they're in. It doesn't get to the point to require hospitalization. In our research, both in the clinical study, but in the market research we did, we learned from both physicians and patients that the agitation episodes come in different levels of intensity. We've found that about 1/3 of the episodes are mild, 1/3 are moderate, and 1/3 are severe. Often an episode, a mild episode, can escalate to moderate, which can escalate to severe. The goal here is going to be when you have a medicine that is uniquely designed and specifically indicated for this condition in the at-home setting, you help patients avoid the escalation that can lead to the hospitalization. Okay. That's super helpful. Thanks. Yep. You bet. Moving on to the next slide. Here, we'll begin to talk about how we're thinking about bringing IGALMI to market and the impact that we think we can make on the market. Basically, we have an opportunity to redefine the standard of care. Now that we have a medicine that is specifically studied for and specifically indicated to treat patients in the outpatient at-home setting for the first time, because nothing is indicated today, we have an opportunity to help patients treat themselves. This was very, very motivating to patients. What do we need to do to make this happen? One is to elevate the recognition of agitation in the at-home setting as being a real condition that happens frequently and can be treated with IGALMI. As we do that, we'll then look to establish that the right way to treat is as early as possible. As symptoms are coming on, have IGALMI on hand, treat it, don't let the episode escalate, which may lead to hospitalization or worse. As we're successful in establishing the practice of medicine and the pattern of care in IGALMI as a new standard, we can then work with the guideline agencies, the pathway agencies to hard code IGALMI into the pathways, into the guidelines. At a 30,000-foot view, this is the opportunity that we have. I'll say that for people with agitation who experience this at home, schizophrenia and bipolar patients experience this at home, this is like having the EpiPen. It's a great analogy. Patients who are at risk for allergy, severe allergy, they have an EpiPen on hand, and that's what IGALMI is going to present to our patients. Moving forward, as we think through the different audiences, the kind of work that we'll be looking to do in the period leading up to launch, it's all scientific communication. We've got great data, so we want to get that data out. We want to be presenting the data and elevating awareness about the unmet need that exists in helping patients with schizophrenia and bipolar who experience agitation at home. It's elevating the awareness of the unmet need, and making sure that physicians have been exposed to the SERENITY At-Home data. There are many scientific congresses that we can get to present the data. We'll be engaging with physicians and some physicians in the context of advisory boards to get their advice on how we can best bring the message to the market. Obviously leverage those insights in the finalization of our go-to-market plan. Mark, I just wanted to jump in real quick. If you just spin back one slide, if you don't mind. I don't want to get too granular with this question. As far as these congresses are concerned, can you talk about what you as a company are permitted to do and say at these conferences under the regs, and who from the company is allowed to participate in these congresses? Are they medical affairs people? What can you say about these- Sure. Oh, yeah. Absolutely. All of this is done under scientific exchange. We have great data. The data gets written up in the context of abstracts and posters and publications. We have, obviously, medical people within the company. We'll be adding to our medical affairs leader, who's within the company at this point, eventually a team of MSLs. All this will be done in the context of scientific disclosure. Thank you. Yep. You bet. Moving on to an important part of the building blocks for the launch plan and getting ready for launch is preparing the value proposition, the data that goes into building out the economic justification to the payers to make sure that IGALMI is broadly available as quickly as possible. This is not a flipping the light switch exercise. It'll involve significant conversation with payers over time, understanding their needs, understanding their level of awareness of the situation, and probably in many cases, I expect we're going to have to do some education here because when you enter a situation where nothing is specifically indicated, there's going to be the need to educate payers on why a fast-acting sublingual pill or sublingual film that is calming without being sedating that the patient can administer on their own at home is better than an oral atypical, which is being used now in the case of the at-home setting, which does not work fast and exposes the patient to atypical side effects, or a benzo, which is a controlled substance and exposes the patients to other side effects. So there'll be the need to educate. The point here is that with the payers there's a value proposition to be built. There are pricing and contracting strategies to be developed with the goal being that we get to launch and through the launch year with the opportunity to establish formulary presence with as little friction to patients as possible. Moving on to the prescribers. Mission critical for the launch of IGALMI in the at-home setting is going to be educating prescribers. The prescribers in this particular case are basically doctors that treat schizophrenia and bipolar. This is a market that I know well. We've talked to these doctors over many years. It's a very concentrated group of physicians. Approximately 65% of the opportunity in schizophrenia and bipolar is covered by less than 10,000 doctors. It doesn't take a very large sales force. If you figure, I think on the order of magnitude, we're talking somewhere in the 80 rep range to cover this kind of opportunity. With a relatively small sales force, we're able to cover 65% of the opportunity from an education perspective. Over time, obviously we can expand as we gain traction or as we move further and have additional indications for IGALMI. Mark, you anticipated my question about the size of the sales force, so I'll leave that alone. Sure. In terms of the physicians, is this an 80/20 type of situation or where 80% of the scripts are written by 20% of the docs, or is it more evenly distributed? No, it's definitely 80/20. It's probably even more concentrated than that. We're covering 65% with less than 10,000 doctors. It doesn't take that many more doctors to get to 80%. Thank you. Very concentrated footprint. Thanks for that, Michael. Moving on to the patients. Once we have physicians educated and we've got really good access through the payers. Importantly, the payers, we're talking not only Medicaid and Medicare, which are important for schizophrenia, but the commercial payers are going to be important for us. Once we have really good access across the payers, messaging the patients is going to be important. This is not something we'll do at the beginning, but I think in the fullness of time, there's an opportunity to help patients recognize that there's a new medicine that can help them manage their agitation on their own at home, help them understand how easy it is to use, give them the confidence to know when and how to treat themselves, and in some cases help educate the caregivers to support their family member with schizophrenia and bipolar to treat appropriately when they feel the agitation coming on. In the fullness of time, there's definitely an opportunity for consumer messaging. I'm not talking big DTC from day one. I'm not even talking big DTC in the second year. Very targeted messaging opportunity. At launch, though, what will be important for patients is making samples available to patients through doctors' offices, and in those samples, having patient starter kits that make it very clear what this medicine is and how to use it, how to administer the dose to yourself. Of course, we'll have those dosing instructions available online as well. Wrapping up, and then Michael, we can get to whatever questions you and others have. IGALMI, it's a great story. The clinical data that was completed in last September came through very nicely, studied 250 patients. Those 250 patients had over 2,500 episodes of agitation that were successfully treated. Largely what that study showed is that patients can dose themselves successfully at home with IGALMI. That data has been packaged. It's been submitted to the FDA. We've got a PDUFA date, November 14th. We have a really good work plan for the next nine months to get us ready to launch. Assuming success on November 14th, we'll be ready to launch in the first quarter of 2027. I'll wrap up there and I'm happy to take any questions. Thanks, Mark. That was brilliant. Yeah, I have to commend the company for having done an extremely thorough job of not only conducting trial, but some of these, the comparator trial for sort of basically operating the patient's ability to treat themselves is outstanding. I think that, in my opinion, reduces regulatory risk pretty significantly. Mark, let's start off with kind of the patient vignette. What does it look like to live with bipolar or schizophrenia and being someone who gets these fairly frequent bouts of agitation? Walk us through what that experience may look like. What happens or what is the patient's options when there's no options available and it escalates into a crisis? Maybe you can talk a little bit about that. Sure. I'll take that one. Thank you, Michael. Look, schizophrenia, bipolar, these are serious mental illnesses. These are distressing, debilitating, very serious medical conditions. They are controlled with strong medicine, typical and atypical antipsychotics. They're great medicines. They help patients significantly, but they have a lot of side effect burden. Bipolar, the mood stabilizer is the same. First, you have to think about this in the context of the underlying medical situation that these people are already working through. Then on top of that, a patient who is diligent with their medicines, they're well-controlled, they're living in the at-home setting. They then have, and we know from the research, many of them will have breakthrough symptoms of agitation. These are distressing symptoms. As I said earlier, the symptoms exist. You've got emotional symptoms, where they get anxious. They feel kind of uncomfortable. It can escalate to behavioral, where there's verbosity in escalating situations, aggression. We've heard from patients who experience this at work, where they basically become not only dysfunctional at work, but they potentially are exposed to losing their job. It's a very distressing situation for patients. Up until now, without anything specifically studied for and indicated, they're left to use off-label medicines. Right now, what is used are the atypicals, which I said earlier, exposes to even more side effect burden, or the benzos, which have different side effect issues and also are controlled. In the case of escalation, if they're lucky, they end up back in the ER. If they are so agitated, so out of control, so belligerent, some patients end up in handcuffs. It's just a terrible case from a patient perspective. The ability, and I'm going to go back to the EpiPen analogy, because I love the idea that for the first time, these patients are going to have something that they can carry with them, whether they're at home, whether they're out in the park, whether they're at their job. If they feel this coming on, they can control themselves. They can dose themselves. As I said earlier, the nice thing about IGALMI, the profile at the highest level, it calms the patient without knocking them out. That's what's very attractive here. Your comment about they feel it coming on. There is a prodromal effect in many cases? Yeah, I wouldn't describe it as prodromal. It's not like a migraine prodrome. Before someone is moderately or severely agitated, they're mildly agitated. They do feel kind of an internal disquiet and an internal anxiety that if not addressed, and people have different coping mechanisms, but if not addressed, it can escalate, and that's what we're trying to get to. Got it. Okay. I think you also answered one of the questions that was in the question queue about the benefits or downsides of benzos and the other agents that are used off-label. Now it sort of bridges into what changes now that there is an option where something could be used, a substance could be used earlier in the home instead of waiting and calling either 911 or the ambulance comes. What is it about the mechanism and formulation of IGALMI, the speed of onset, tolerability, all the, as you mentioned in your formal comments, the TPP that makes it well-suited into that moment in a way that the existing off-label options do not? Well, I think you just said it yourself. It's first, fast-acting, right? Onset of action as quickly as 20 minutes. That is really, really important. In the ER setting, what is indicated and used are often the IM, so the injectable atypical antipsychotics, or IM or IV benzo. The reason that they're administered intramuscularly or intravenously is for speed of onset. Now you have an opportunity to get speed of onset in the at-home setting with a medicine that patients can administer themselves. As I think about IGALMI, if one attribute that is highest on the priority list of attributes, it's absolutely that. It's patient can administer it themselves and speed of onset. But beyond that, next, this is not an antipsychotic. This is not a benzo. This is a novel mechanism that calms the patient without sedating them. We saw this in the clinical studies that the patients as part of the clinical work, they had to respond to questions every 10 minutes, and there was no patient that couldn't respond to questions. That's very valuable because, in the ER setting, often patients are knocked out. In fact, I'm going back many years when we were developing aripiprazole, Abilify, for IM injection. One of the issues was, and what we thought Abilify would hopefully overcome was, patients that get an IM Zyprexa, they're knocked out. When the patient's knocked out, they're taking up space in the ER. The doctor can't intervene until the patient is aroused. That's not the case with IGALMI. Yeah, they can't go back to work if they work or. That's exactly right. Yeah. That's exactly right. There's productivity. All right. I'm going to ask a couple more questions. We're getting a bunch of questions in the queue, which is nice. The ones that have been addressed, I will not bring up, but the ones that have not, I'll hope to get to. Just a couple more questions, Mark, before we get to the online questions. Again, the size of the opportunity, I kind of asked this before when we talked about the 86 million versus the 16 million, but in sort of, again, the real-world setting, how does that funnel down? Are there patients that are not so severe that they just sort of ride it out, or are there others that medicate with other things, alcohol or Yeah substance abuse or whatever, but how does that funnel down? Yeah, that's a great question, Michael. I'll just talk through the funnel first, and then I'll talk about what we heard from physicians and patients around how patients within the funnel would be treated. At the top of the funnel, you have about 8 million diagnosed people with schizophrenia and bipolar. Of those, about 6.5 million are treated. Of those, we then took cuts based on, are they living at home? Because our population, those living at home, and what share of those patients have frequent agitation? We got this by asking doctors, "Okay, think of your population. What percent of your schizophrenia and bipolar patients experience frequent agitation defined as 10 to 15 episodes per year?" That got us from the 6.5 million down to 2.3 million. We then took one more haircut, which was based on these 2.3 million. Let's make sure that we are screening out patients that did not fit the SERENITY At-Home entry criteria. For example, if a patient was abusing illicit drugs in the last six months, they were excluded. We excluded about 20% of the patients. That got us to about 1.8 million addressable patients, and in the study, we saw that on average, four episodes per month, that's 48 per year. 48 times 1.8 million gives you the 86 million episodes per year. In our research, and very consistently, whether we talk to patients, whether we talk to doctors, those episodes appear to be 1/3 mild, 1/3 moderate, and 1/3 severe. First, I'll say that in the clinical study, in the SERENITY At-Home study, the product works regardless of the level of severity. We saw a reduction in agitation, whether the patients were mild in severity, moderate in severity, or severe in severity. From a clinical perspective, we know that it works across the spectrum. Then we asked physicians, and we asked patients, "Well, would you reserve this just for severe cases, or would you want to use it in mild cases to prevent the escalation?" The general consensus was, "You know what? We're going to use it across the board." Because if you're mild and moderate, you obviously want to avoid escalation to severe. If you're severe, you want to manage that. I think that broadly, there's going to be broad interest in this. Once we get out in the real world and patients have experience with it, I suspect that doctors and patients will develop their own strategy around when is my agitation the kind of agitation that I'm going to jump on, that I'm going to take my IGALMI for. Right now, based on what we know today, it works well across all three disease spectrums, and there's no reason to think that it wouldn't be used in all three. Okay. Great. I just wanted to ask one more question on reimbursement, and then I'll take the questions that came in online, and if there's time left, I can come back. As far as the payers are concerned, a couple of questions on that. Have you, as BioXcel, undertaken any kind of pharmacoeconomic study to demonstrate to the payers avoided costs of hospitalization, lost productivity, risk to ER personnel, et cetera? Have you done any studies like that? And then in the case of Medicare, Medicaid, dual eligibles, how does that situation look? Because I know there's a fair number, a fair proportion of patients with schizophrenia that are unfortunately indigent. How do they get covered, and do you have to go sort of state by state with that population to get your approvals? Yes. Both good questions. On the economic model, we've done no HEOR work yet. That's in the plans. Let me just point out an obvious point of practicality. Before the drug is on the market and has broad use, the models we'll be building will be hypothetical, theoretical models, right? Post-approval, once we actually have use, we can then reinforce those models with real-world data, and bring really robust economic justification models to payers. In the launch period, we'll have a nice model that will project the opportunity to offset costs of an ER visit or hospitalization based on using IGALMI. Although I'll tell you, and that's going to be important for the payers. At the same time, we're not going to shy away from painting the picture of patients today that are in distress because the drugs that are available to treat acute agitation at home are not great. This is a new paradigm, and having the freedom to carry medicine around that can help abort a case of agitation quickly, whether the patient's at home, in the park, at work, is very valuable. That's the case from the health economic perspective. To the Medicaid, yeah, Medicaid and dual eligibles, Medicaid's a state-by-state thing. We will have to go state by state and do what's necessary to get this on the state Medicaid formularies. Is it easy, how difficult or straightforward is it to access those patients? It would seem kind of challenging. In my experience, we're talking patients with severe mental illness. There are protections in place for this category of patient, this category of these medicines. Nothing's ever easy, but there will be willingness to hear the story. I'm fully sure of that. Okay. Wonderful. All right. Let me take these questions in order of which they came in, because I think that's the only fair way to do it. Question is, how do you think about preventing overdosing in the real-world setting? Yeah. Nice question. We know from the payers, this is a medicine that will be used episodically, not chronically. One of the criteria from the payers will be quantity limits. First, patients will not have a large number of film strips on hand. It's too soon to say what the limit will be. If you extrapolate from the fact that on average we see four episodes per month per patient, you need to think about more than four episodes per month, because you don't just do for the average patient, you need to make sure you're covering most of your patients under your quantity limit. The medicine is designed to be redosed within 12 hours, so one episode could get two doses. I would expect, maybe patients have 10 on-hand at any given time. The second thing to realize is that the underlying medicine, dexmedetomidine, is used in the ICU setting as a sedative anesthetic. This is not the kind of medicine that's going to get overdosed from a, "Hey, I like this medicine, I want to take more of it." If someone does take two or three, the primary thing is that that will happen, is they'll get tired. I know the company's had those discussions with the FDA. That was an important part of doing the at-home study and demonstrating that it could be safely administered by patients in the at-home setting, and the clinical data stands for itself. 250 patients, over three months, were able to identify when to treat themselves and how to treat themselves, and to treat themselves on their own without medical supervision. I would add to your comment, Mark, about the opioid withdrawal studies used doses of 240 mcg. We know- Yeah We know that if you get approval for the high dose at 180 mcg, you have clinical experience with a dose that's at 240 mcg. Yeah. That's one, if the question's concerned about safety. The other point I would make from the question about sort of the maximum amount of drugs someone could have. If you look at lofexidine, which is marketed under Lucemyra, that is typically given three tablets, 4x a day, maximum of 16x a day, and up to a maximum of 14 days. There may be some constraints put on IGALMI at home as well. Is that fair to say? Yeah. Yes. I think the primary constraints will come from, look, this is a medicine that's designed to be used episodically. Let's estimate how many episodes should we reasonably expect to treat over the course of a month and make a prescription based on that. Perfect. This question is related to that, which is, based on the payer feedback, what do you think the pack size will be? Sorry, the pack size will be that they will accept per prescription. I think we've talked about that. I don't know if there's anything to add there. Yeah. Not really. Right now it's packaged in units of 10s and 30s. I think the 10-pack sets up nicely for a monthly prescription. What's interesting about IGALMI, the film strip itself is actually individually packaged in a sealed package that has its own NDC code. Whether we put five films in a box or 15 films in a box, those changes can be made pretty quickly. Right now, we've got a 10-pack, and that feels like a good number. Okay, perfect. This has to do with TRANQUILITY. I think I'm going to skip over that and come back to it. Let me just say, I want to stick with some of the, yeah, let me ask this. I know I'm going out of order now, but there's a question about, again, a clinical presentation of agitation. It says, "How long does an agitation episode typically last if untreated, and will IGALMI simply shut it down? How long does it last? Yeah. How long does it last? I guess it varies. Yeah, it varies. What we know from the experience is that IGALMI works quickly, as quickly as 20 minutes. Right. Okay. Here's another question in here about the number of units in a pack, so I think I can skip that. Let's see. These others have to do with strategic questions. Maybe Vimal, I can get you involved here. There's a couple of questions. Company in talks with any major pharmaceutical company, potentially partner or assist in the marketing. Are you looking at partnerships to help with the launch? Yeah, those are the two questions that are related. Those are very relevant and good questions. We are exploring all opportunities. Part of the exercise Mark is working on, we are evaluating what is required to launch this product, and some of the work has been done, and some of the work is in progress. We are looking at all options to make sure we can bring this medicine to as many patients and caregivers we can, which could involve established footprint with a partner to co-commercialization to other opportunities. We are quite open, and we are working on it, and we want to get to that by the time we get to the day. Terrific. I know what the answer to this question is, but I think you should at least address it, Vimal, which is, with 80 reps, what are you estimating your cost of launch in 2027? I think that work Mark and team are doing what the total cost will be. It's just not the rep cost, it's additional things that you require to launch the product. Having a strategy, what strategy we are adopting, in terms of what we discussed previously, what options we're going to use, then we will be able to provide more guidance, what the cost will be for the launch. Okay in 2027. I like that answer. Also, you think the product's appropriately priced at $105 per film, given the value it brings to the table, especially at the in-home setting. How much do you think a patient copay would be for that? I think it's kind of tough to say, but I'll ask it anyway. How many films do you think would be in an average initial Rx? We already talked about that. Maybe the first two questions of $105 per unit and then, I don't know if you can speculate on the copay. I don't know how you would do that, but go ahead. Sure. When we did the research with the payers, and again, this was, I would say, preliminary research to get a sense for how they would think about covering this on formulary, and we got positive feedback there. We were transparent that right now the products available is priced at $105 per film, and really had no pushback there. I think where their head went was, okay, in the neuropsych market, a new branded drug is typically pric ed $1,500-$2,000 per month. Here we have a medicine that works in the same space, but it's about $100 a dose. How many doses per month? Well, it's not going to be 15 or 20 doses per month. I think they felt, "Okay, this seems reasonable." As far as copays go, once we get to Medicaid, the Medicaid copays are low, so it's just a matter of getting on the Medicaid formularies. The commercial copays will vary. Obviously, our strategy will be to work with the payers to very clearly elucidate the value proposition to the payers, to physicians, and importantly to the patients, so that they don't put extreme hurdles in place for these patients. Patients are suffering enough. Let's let them get access to important medicines at a reasonable out-of-pocket. Quite frankly, with the commercial patients, if we find that the out-of-pockets are too high, there are things we can do. Right to help lower those in the commercial world and Yeah, you can do copay assistance. That's right. That's part of the consideration. You can do copay assistance, you can do couponing, you can do sampling. I mean, there's a lot of strategies you can employ. That's exactly right. Yeah. That's exactly right. I think this is a bit redundant, but just in order to make sure everyone's happy on the asking questions online, I think the better way to ask it is, do you feel like your sales and infrastructure and capabilities can support a full U.S. launch, or would that require additional partnerships? I'll let you address that as you see fit. Yeah. I'll take a stab and, Vimal, you might want to jump in. At this point, we have a great launch plan, so the work that we will do between now and launch, and we have an emerging, finely tuned view of what a successful launch infrastructure needs to look like. All that is to be built over time. As Vimal alluded to, he's talking to a lot of folks, and what exactly the launch, the go-to-market infrastructure looks like will really depend on that. Vimal, anything you want to add there? No. I think that's pretty much. Currently, we have some advantage because we did do the launch in the institutional setting. They are helpful. For home setting, we will have to build the infrastructure that Mark mentioned. Okay, terrific. I'm going to come back with some questions of my own in the closing minutes, but let me just put up two more, which is, what are the key milestones investors should watch between now and the PDUFA date that could meaningfully change your trajectory? I think approval is a major catalyst. Right now, we are in the review process for our sNDA and preparing for a launch, which the commercialization activity is ongoing with Mark coming on board. In addition, we already have alignment with the FDA to initiate second confirmatory phase III trial for our Alzheimer's agitation program. Initiation of that program would be a key to expand market from schizophrenia, bipolar-related agitation to another indication in Alzheimer's. I think those are the key value drivers for BXCL501 program. Okay, great. I'm going to piggyback on this question, well, this question is asking about TRANQUILITY. We know you got breakthrough therapy designation for Alzheimer's agitation, but studies are currently paused. Vimal, you just mentioned TRANQUILITY. I guess, what are the obstacles to getting those started and the question is, would you convert TRANQUILITY trials to at- home trials? TRANQUILITY plan will be that we have done one phase III trial in ALF, assisted living facility, and we have demonstrated 60 mcg dose shows positive results both from efficacy and safety perspective. Now, we need to do a second confirmatory trial, which is covering broader population, ALF, memory care, as well as nursing home. We are covering whole spectrum of Alzheimer's paradigm, the patient who get maybe mild, moderate, severe agitation, mild, moderate, and severe. That's the second confirmatory study that is required to expand into the Alzheimer's agitation. In that, as I mentioned, we have alignment with the FDA on the protocol, as well as we have selected a CRO, and we are geared to initiate that trial, and we will announce when we can initiate that plan. Okay. Maybe talk a bit about because I think the exciting part of this story from my perspective as an analyst who tries as hard as he can to make money for his clients just how large the opportunity is, Alzheimer's agitation, opioid withdrawal, how do these add the layers of addressable patient populations? Good news is that BXCL501 has a potential pipeline in a product potential. CNS is very unique mechanism, and it can apply to various condition which you mentioned. Currently, company is focused on schizophrenia, bipolar agitation, and now institutional and home setting with potential approval with this sNDA. Alzheimer's agitation expand into that indication. Both of them are extremely large opportunity from a company perspective. Potential is more. As you have seen, we are conducting investigator-initiated trials, and this is a clinical and scientific community who gets funded from the outside, and they are running these trials in opiate withdrawal, as well as recently we announced that acute stress reactions or acute stress syndrome, that happens prior to the PTSD. There is a trial that is being run funded by DoD, by University of North Carolina, and opiate withdrawal by Columbia University. We continue to supply the drug to continue to get clinical signal that can expand. Company is currently focused on those three indications, schizophrenia, bipolar, and Alzheimer's, because these are really large opportunities, and BXCL501 can have a large potential once we succeed in these three indications. Great. All right. There's one more question in the queue. I might ask it a little differently. The question is about, now that you got a PDUFA date, have the discussions with potential strategic partners changed at all? Has that moved the needle, I guess I would say, in terms of the partnership interest? What we observed was that as you do the de-risking of the opportunity, which was first phase III data that came in last fall. It was submission of the sNDA and now acceptance of the sNDA. All these things result in increasing the interest. That's what I would say. Yeah. I'm sure it's a cumulative effect. Okay. Well, look, we're just about at the top of the hour. I just wanted to close out, or at least Vimal have your closing comments. I'll make some brief remarks, and then we'll wrap things up. Anything you want to say in closing before we go? No, I think this is great that we were able to host this session, and I would like to thank you, Mark, and thank you, Krishnan. As we have highlighted, we believe IGALMI represents a significant opportunity to have a real impact on the lives of patients and caregivers managing acute agitation in home setting. In the next several months, we will continue to advance our commercial launch preparation, and we will get nearer to the potential approval announcement. We appreciate everyone joining us today and your continued interest in our progress. We look forward to keeping you updated as we move ahead. Great. Thank you, Vimal. Thanks everybody for joining us here today. Again, it's been my pleasure to moderate this event. When we first heard about the BioXcel story, we got very excited about it. I'm old enough to remember a company called Avanir many years ago, that had a drug that there were a lot of skeptics about. Turned out to be a terrific drug, a terrific launch, and a wonderful exit for the company about 10 years, 12 years ago. I see lots of parallels between the BioXcel story and Avanir from my past as an analyst. Again, we appreciate the company management team taking the time to do this for everybody, and we wish you an enjoyable rest of your day. Thanks, everyone.