Awesome. Thank you very much for joining us today. My name is Mohit Bansal. I'm one of the biopharma analysts here at Wells Fargo, and I'm very happy to have Andrew Miller with us, founder and Chief Executive Officer of Karuna Therapeutics. Thank you very much, Andrew, for joining us. Yeah, it's great to be here. Great. So let's just start with, I mean, a lot of people know Karuna by now, but, let's just talk a little bit about the current programs and timelines and what we are looking forward to in the next- Yeah 6-12 months, I think. Yeah, absolutely. Obviously, most of our external discussion factors around KarXT, our lead program, as a novel muscarinic agonist antipsychotic for the treatment of schizophrenia. When you think about what the upcoming activities or ongoing activities are, we're gonna be submitting our NDA for the treatment of schizophrenia here before the end of the quarter, so before the end of this month. Obviously, it's a heavy lift for us, but obviously great to make that much progress, and we're really in the final stages of tidying that up to get it into the agency. So feeling in a really good place with respect to the NDA submission. We currently have seven ongoing phase III studies with KarXT across several different indications. Two of those being the continued, ongoing 52-week safety studies for the treatment of schizophrenia. We have the ARISE program, which is adjunctive treatment of schizophrenia and associated long-term extension. And then we have the ADEPT program now ongoing, all three ADEPT studies, ADEPT-1, ADEPT-2, and ADEPT-3, being a randomized withdrawal, a parallel group, double-blind study in ADEPT-2, and then a long-term safety extension in ADEPT-3. So always keeping busy with respect to what the activities are. We do also intend to be speaking, you know, perhaps early next year about some additional development opportunities as we think about expanding the use of KarXT, not just in schizophrenia and into the elderly and dementia, but potentially the pediatric populations as well. And then have a growing pipeline of products, including a TRPC4/5 antagonist for the treatment of mood and anxiety disorders, and a series of muscarinic targeted programs capitalizing on all that we've learned and understand and the expertise we have with respect to muscarinic receptors. Great. One question I do want to ask, like, you know, I was part of the IPO team back in 2019. It has been four years. I mean, if I remember the timelines you provided back in the days, you have been matching those timelines, which is quite an achievement if you think about the small company Karuna was back in 2019. What is the secret sauce and how you have been able to manage that? Yeah, I mean, I don't know what the secret sauce is per se, but I think we've been very focused- Yeah -on what we think the most important activities are. I also think the data has turned out in a way that's allowed us to really stick to the plan- Right -that we set forward four years ago. So, you know, as much as KarXT is a completely unique product, and again, I think perhaps the first mechanistically unique antipsychotic since the first was launched over 70 years ago at this point. The clinical trials that we run, the endpoints we use are well precedented and established. And so if we go back four years, what we've completed from a development perspective also matches essentially identically with what we were planning at that point. So I think that's helped us. I think we've also just continued to, you know, focus on operational expertise with respect to our clinical programs and clinical trials, and obviously, the pandemic presented a whole host of challenges- Right -to everyone. You know, global geopolitical conflict in Ukraine and Russia posed some challenges to everyone, but we've been able to navigate those and feel really good about where we are. And look, we need to continue to do the same going forward with the ongoing programs I mentioned earlier. Great. So let's just talk about the first, regulatory part of it, I mean, your submission of NDA. Some investors are seeing this as a catalyst, the acceptance of the NDA. Can you talk about in terms of the gating factors at this point, I mean, how much part is done in terms of submission and then, what requirements are still remaining? Yeah, I mean, I, I think at this point we're 99.9% done. Okay. So really the last few weeks here are talking about QC, making sure all the electronic formatting is done correctly, et cetera. You know, NDA filings are quite substantial documents. Sure. Ours is probably 400,000+ pages, so pulling it all together, dotting the I's, crossing the T's, making sure it's gonna go through the FDA electronic gateway are all important activities. But it's really blocking and tackling at this point to get that in. Got it. And then in terms of the review cycle or review time- Mm Like, what should be the base case assumption for investors at this point? Yeah, I mean, well, I can tell you what our base case assumption is- Sure -which is a standard review. You know, that's really based on, I think, precedent and a review of the regulatory processes and procedures around a potential priority review. You know, if novel mechanism, new class, were designations that got you expedited review, I think we'd be in good shape. But expedited review is based on substantial advantages on safety or efficacy. And for efficacy in psychiatry, that tends to mean a head-to-head comparison or studying patients, who have had an inadequate response to, to previous therapies, which is not the basis of our program and is not typically the basis of schizophrenia programs at initial submission. We're also working with the division of FDA that has granted exactly one priority review- Right. - with respect to psychiatric products. So the different divisions, I think, handle those programs differently. Much more common in rare diseases or oncology, where again, you're studying a unique efficacy aspect or you're studying patients who fail to respond to current standard of care. In the past, you talked about Priority Review Voucher. Is there a possibility at this point, or? Yeah, it's something we seriously considered, and I think just on the basis of, you know, a simple financial calculation, the math kind of makes sense for us, given what the expectations on the product are. But I think in light of more, say, the human factors. Right - side of it, with respect to what a voucher means, what it's obligating the agency to do and where we sit with our submission in two-part strategy, really felt like that, you know, give or take market value, $100 million was something that we felt like was better invested elsewhere. Right - in the program. So that's sort of where we, we landed on it. Got it. Makes sense. Let's just talk about the blood pressure trial, which, I think, a lot of people have talked about it. So what is the genesis of this? And how... Like, do you see any risk there? I mean, people are talking, like, all those different things here, but do you see any risk with the trial? And this is... How it is different from seeing blood pressure rise at the Cmax level versus doing an ABPM trial? Yeah, so I mean, I think to get to the first part of that, the genesis of why we're running the study, I mean, it comes back to some of the things I've already mentioned, which is we are, you know, developing a completely unique agent from a pharmacology perspective, from a new class of medicine perspective. And I think when you find yourself in that situation, we were sitting here a year ago, you know, in August 2022, with our second positive registrational program, feeling like we have a product. What are the other questions and, you know, I's we can dot and T's we can cross? Yeah. And it felt like, given some of the data that existed with other muscarinic programs earlier in development, suggested of potentially substantial blood pressure increases, felt like the right thing for us to do was say, "We're going to do the most definitive study we can." I think ambulatory blood pressure monitoring studies have become much more common over the last three to four years. It's not dissimilar to how you would think about a QTc study, thorough QT study. Everyone has 12-lead ECG data from all their studies, but that was a point of emphasis from a regulatory perspective, and so it's pretty standard practice to do those studies. ABPM is very similar. It's providing a more definitive data point to supplement the existing clinical data we have across all our programs. And to get to maybe the second part of your question, what is the study? Are we concerned about it? The study, fundamentally, you have an ambulatory monitoring system. Every 30 minutes for 24 hours, you get a blood pressure. Right. You take your baseline, you take it at eight weeks, our study is eight weeks in duration, and you look at that change as a 24-hour average change. Right. There's various QC that goes into that in terms of measurement, accuracy, et cetera. So basically, it just provides you a more robust blood pressure data point, helps reduce variability. Our study is eight weeks. It's longer than our five-week acute pivotal studies, but other than that, it has the same fundamental design. It's the same dosing. It's patients with schizophrenia. If you take our data from EMERGENT-1, 2, and 3 and put it into the ABPM paradigm, we would expect to be successful from a primary endpoint perspective. The study is already done from a data collection perspective, so we're in the data cleaning and analysis stage here. Coming up pretty soon, we'll have a top-line data readout in the fourth quarter, and I think based on what we've seen from the study, our expectation is we will be successful on the primary endpoint for that study. From a timing perspective, we're well inside of the window for the day 120 safety update- - which is, you know, that's the conversation we had at, our pre-NDA meeting in terms of timing. So I think we've really resolved any meaningful risk at this point around the ABPM study. What's the good data? It's like within 1-3 points of change? Yeah, I mean, the statistical endpoint is basically to have the change and the upper bound of the 95% confidence interval to be below a 3 mm Hg change. Right. Statistically rejecting the hypothesis that you have a 3-millimeter greater change in blood pressure, which is not something that we saw as part of our previous studies. Right. We had a high degree of confidence kind of coming into the trial, and I, I think we're going to end up with a positive result. Got it. So, I mean, basically, like, what you saw with the EMERGENT-3 or -2 program, where you saw a transient increase in blood pressure at the Cmax level of the drug or two hours after the drug, that's not the... That's not what you're measuring here, so that's why the risk is not the same. Correct. So I, I think one of the things that came out of EMERGENT-2 and EMERGENT-3 was a small percentage of patients having an AE that ended up getting categorized as hypertension. Right. It wasn't a hypertensive syndrome. It's really related to, was often single time points in the study having an elevation in- Sure blood pressure. And when you look at the way the ABPM study is designed, you know, one thing is any effect has to be durable. Right. Right? A short-term effect is not a long-term risk. And the measurements are done in a much more robust fashion. There's less variability and less error. As I think everyone appreciates, blood pressure can change relatively rapidly and be very context-dependent, and ABPM is a way of sort of getting rid of a lot of that noise. Depending on your answer, my blood pressure is changing. Just kidding. So... No, this is super helpful. Maybe moving on to ARISE trial here. I mean, you-- I mean, again, kudos to you. You are running a comprehensive program with now with ARISE, you are doing an adjunctive study. So can you talk a little bit about the significance of this trial, because you'll get monotherapy approval, but eventually the usage could be adjunctive here. So talk a little bit about that, and, and talk a little bit about how should we set the expectations, because this is not a monotherapy trial, so the bar is not 8 points or 12 points of improvement. So- Sure. Should talk a little bit about it. I mean, I think with respect to the adjunctive program and sort of why we ran it and its level of importance, you know, as I mentioned earlier, we have what we believe is a completely new class of medicine in an area where we have a complex heterogeneous disorder that's poorly served by effectively one class of medicine. And when you look around other disease states and therapeutic areas, when you have multiple options available, you tend to have different lines of therapy. You tend to use them in conjunction with each other. Certainly, that's the case in oncology, and I think that's how schizophrenia should be treated. We just don't have therapeutic options that are distinct, and I think KarXT really represents that. Now, we would expect initial indication, a labeled indication for treatment of schizophrenia in adults, again, based on the precedents that exist for approving, antipsychotic medicines for treating schizophrenia. See, the adjunctive study, the ARISE program, is not about increasing or expanding the labeled indication in terms of who might be eligible to receive KarXT. It's about reinforcing the uniqueness of KarXT. Right. We know that right now, 30% of patients with schizophrenia receive two dopamine antagonist drugs on top of each other, despite the fact that there's not well-controlled data to support that as an effective use case scenario. It's representative of the fact that the vast majority of patients are underserved by current treatments. As many as 75% are discontinuing or switching medication in an eighteen-month period of time. There's constant churn. Side effects build up over time. So it's a very dynamic market from that perspective, or a very dynamic treatment paradigm. If we can further reinforce the idea that KarXT, in that adjunctive setting, has demonstrative benefits, I think that would be helpful in reinforcing the value proposition. Now, in terms of expectations, what does success look like in the study? You know, in its simplest form, success is statistical separation on the total PANSS from placebo, change from baseline, and it's of a magnitude that's clinically meaningful. Right. Now, clinically meaningful, the precedent for that, I would say, is there are monotherapy agents approved with total PANSS changes of as little as four points for specific. Right. Now, in the EMERGENT one, two, and three program, we saw anywhere from 8.5 to 11.5. So we could see half or potentially less than the benefit we saw in the EMERGENT program, and it's still, still clear both of those success metrics. Importantly, it's less about... I think for monotherapy in the EMERGENT program, it's very important for us to establish KarXT as a robust antipsychotic medicine. Right. I think we did that. We have an effect size that is above all of the commonly used treatments available today, without all the problematic side effects. I think in adjunctive treatment, without precedent, without comparison, it's less about what the magnitude of that benefit is and more the idea that in a safe and effective manner, you can use this on top of current standard of care. Right. This is more to make sure that in real world, when people use it as a combination, they have the data to support that. Right. Look, psychiatrists are constantly searching for something or some combination or some agent that might work a little better for in their patient for reasons that perhaps aren't well understood or are hard to predict. So they're going to use KarXT in perhaps many of the same circumstances and situations they use existing products, which right now, 30% of the time is in conjunction with another D2 agent. So I think they're already thinking about all of these different use case scenarios. The better we can support that with data, I think that'll serve patients well. Got it. It makes sense. Maybe so, I'm just trying to figure out. Let's just talk about the EMERGENT-4 and EMERGENT-5 program and also, ARISE trial. These are outpatient trials, right? Correct. So what are the... Again, with inpatient trials, you can control for a lot of variables, especially the placebo effect. In outpatients, you cannot. So can you talk a little bit about that, or is it for the real-world use, and how is it about it? Yeah, well, I think I wouldn't necessarily say that placebo response is easier to control in inpatient because I think it's about expectations of benefit in- Sure ... in large part. But I do think, inpatient studies, do help control for some other factors with respect to life circumstances, et cetera, which can increase variability- Right ... in studies. Now, EMERGENT-4 and EMERGENT-5, the primary objective is really to establish the long-term safety- Right ... of KarXT. So they're both 52-week, open-label safety studies. Really, the only difference being EMERGENT- 4 rolls over patients who completed EMERGENT- 2 / 3- Sure ... and EMERGENT-5, operating at different sites, recruits patients de novo into the program. They're really meant to build the safety database to support the submission. Data from those studies is going into the submission. Additional data will then go into the day 120 safety update. And so it'll support that review process. When you think about what the label looks like, the label generally reflects the placebo-controlled- Sure ... studies, EMERGENT-1, EMERGENT-2, and EMERGENT-3. There'll likely be an adverse reaction table listing treatment-related adverse effects there. Right. Any other things that are identified in long-term safety could make their way into that. I think the way that we look at EMERGENT-4 and EMERGENT-5 is they're a great opportunity for us to further differentiate the effects of KarXT from standard of care. Right. In EMERGENT-1, EMERGENT-2, and EMERGENT-3, we tend to see mild to moderate, what are largely transient GI side effects. Right. We're likely to see that exact same thing in EMERGENT 4 and 5. But what we hope to see as well is the lack of weight gain, metabolic dysfunction, extrapyramidal symptoms or motor impairment associated with existing antipsychotic drugs, and a whole list of other things that find their way into the warnings and precautions sections of the label for those treatments. So I think it presents a great opportunity for us to do that, to continue to expand upon the short-term studies. And I think that's what we're seeing from our long-term data at this point. Right. And I think if I remember it correctly, part of the reason why you did inpatient trials for EMERGENT-1, 2, 3 was it's hard to keep patient on placebo when the patient is outpatient. Yeah, I think the inpatient nature of EMERGENT-1, EMERGENT-2, and EMERGENT-3, which are sort of acute psychosis trials- Sure. The reason for the inpatient nature is because you do have acutely ill patients, and in our case, 50% of them were only receiving placebo treatment. Right. You know, it's really appropriate to do that inpatient setting, where there's 24-hour observation and care that's available. Right. And so it's really nothing to do with KarXT and more to do with the treatment paradigm in which it was studied, which matches what you would see for the data that's the basis of approval for really all of the antipsychotics approved over the last several decades in the U.S. Right. Makes sense. Another key data set. I mean, trial you are running is the ADEPT program for Alzheimer's-related psychosis. Can you talk a little bit about the design, and how is it... Like, you did some dosing work there- figured it out after a certain point. What did you learn so far in those programs, and then, how are you thinking about success there? Yeah, I mean, I think the story of ADEPT in some ways goes back to the original discovery of the antipsychotic benefits- Right - of xanomeline, which was in an Alzheimer's population. It was originally studied as a pro-cognitive treatment. Someone serendipitously observed these dose-dependent, robust antipsychotic effects, and there were sort of two subpopulations in the study. One, which had these, you know, psychosis symptoms at baseline. Mm-hmm. And you saw this rapid and meaningfully improved response over placebo. And then you also had patients who didn't have those symptoms at baseline. Correct. If you tracked over the six months of the study, you saw a much higher incidence or onset of new psychiatric or behavioral symptoms on placebo than you did on KarXT. So the idea that it could both treat existing symptoms but also prevent the onset of new symptoms. And when you look at ADEPT-1, it's looking at patients who, you know, are treated in open-label fashion with KarXT. Their psychosis or hallucination, illusions substantially resolve, and then they're randomized to continue on placebo or drug. That's that sort of prevention or onset of new symptom paradigm. ADEPT-2 is a parallel group, double-blind, placebo-controlled study, very similar to EMERGENT 1, 2, and 3, where you're taking symptomatic patients and looking to see a reduction over placebo. So it's really representative of the two efficacy paradigms in which xanomeline has already shown benefit in patients with Alzheimer's who have behavioral or psychosis symptoms. So it's precedent based on that, and sort of what you're referring to is what we've done as part of our program, is come back and show that with trospium, the addition of trospium, we can in fact titrate KarXT or xanomeline to dose levels, which were shown to be effective in that Lilly program. So we've kind of come in and solved that tolerability issue and shown that we can dose at therapeutic levels in the elderly. So now in ADEPT One, Two, and Three, we hope to replicate those two findings in the patient population of interest, showing, you know, hopefully something that's tolerated and safe, but also effective in treating psychosis. Got it. That completely makes sense. One question we get is that with the... Like, because you're running a blood pressure study among schizophrenia patients, do you think you need to run a similar study for these patients as well, for others? Yeah. I mean, I've-- that's not an explicit conversation that we've had with regulators at this point. But I think if the results from the ABPM study in patients with schizophrenia is successful in terms of rejecting any chronic blood pressure increase, that would set us up, I think, for the idea that we would likely not need to do- Sure ... the additional study. Obviously, a clinical vital sign assessment we'll have as part of the ADEPT program. If that were to show something that needs further evaluation, then that could lead to another ABPM study, but it's not our expectation at this point. Got it. Makes sense. Maybe moving on to competition a little bit. How are you viewing the competition in M1/M4? You are the pioneer in that space, but now there are other companies coming up. How are you thinking about that? You have head start there quite a lot, but again, the claim is that it's just pure M4, and it could be once a day. So do you think this has a differentiation enough at this point? Yeah. Well, I mean, I think obviously anytime there's the magnitude of discovery that we've made with KarXT, I think there's gonna be a lot of interest in, you know, further evaluating that and incrementing on top of it, and that's sort of the history of psychiatric drug development. We discover dopamine antagonists, and then we incrementally change them for decades. We discover serotonergic reuptake inhibitors, we increment on them for a long period of time, and I think you're gonna see that play out with respect to xanomeline as well. You know, KarXT is not gonna be the only product. You can look at atypical antipsychotics. We just launched the thirteenth as a field, as the industry, a we, global we- Sure ... 30 years after we launched the original. Right. I think that story is gonna play out again. I think KarXT has the opportunity, clearly, to be a first-in-class treatment, but I also think it has the opportunity to be a best-in-class treatment, and particularly from an efficacy perspective. Right. You know, it is impossible right now to quantitate the contribution to KarXT's efficacy profile that comes from M1 versus M4, but I think the best data we have available preclinically from a biological rationale perspective suggests that M1 has a primary role in the procognitive effects we observe with KarXT, but also a secondary role in the antipsychotic benefits associated with xanomeline. So now we don't have the data from any competitive programs in large-scale registrational studies to offer what would be a cross-trial comparison with its limitations about what the magnitude or breadth of that benefit is with respect to psychosis or for cognition. That data, you know, will be available, you know, based on other companies sometime in the next couple of years. I think that will be informative. But again, I think the idea that M1 makes a contribution to the efficacy profile, the fact that the direct agonist activity contributes to the efficacy profile, I think these, those are both backed up by the state-of-the-art science, and I think with more clinical data, we'll better understand how to quantitate those things. Got it. That makes sense. And then, regarding this once a day versus twice a day- Mm-hmm. I think that argument does sound good, but again, at the same time, there are extended release versions of current antipsychotics, which don't do that well. So like, what are the reasons there? Yeah, well, Look, I mean, I think is a once a day option, you know, would be favored over a twice a day option? I think that's an easy question to answer. Sure. I think a much harder question is to understand what the impact of that is in any sort of quantitative way when it's not the only difference between- Right -the two products. You know, right now, what I would say is there's a little bit of conflation of two things. Patients with schizophrenia tend to not be high compliance population, but that is not because of convenience, it's not because of forgetfulness. It's fundamentally because the risk-benefit profile for existing products is extremely poor. You know, a substantial percentage of patients actually believe their medicine does more harm than good. When you look at long-term studies, for instance, that the NIH has run, as many as 75% of patients will discontinue or withdraw treatment in an 18-month period of time. The primary drivers of that are lack of efficacy and side effect problems. So when you think about how to make a product that could potentially improve adherence and long-term outcomes associated with that, you wanna improve the risk-benefit profile. That's the fundamental limitation of existing products. Existing products that are used commonly in schizophrenia are all titrated, often over the course of weeks, not just days. Many of... You know, some of them launched as BID products and were successful in that way. But I think a focus on what the risk-benefit profile, that's gonna be the fundamental driver of, of what's used. I think we're in a very good position with KarXT. Efficacy is extremely important in patients with schizophrenia. I would say it's a bigger driver of adoption than it is on the mood disorder side. I think tolerability is a better or is perceived as more important there. And I think that's reflected in the fact that the four products that are used in schizophrenia right now, most commonly, were launched between 1992 and 2002. Despite eight subsequent product launches, we haven't seen meaningful displacement of those agents because those are the drugs that are, the data supports and the perception supports that they're more effective. Got it. That's super helpful. One question. So talking to you, talking to Cerevel, well, they are talking about bipolar mania as a space to go after with their M4. How are you thinking about future opportunities for either KarXT or a future M1M4 program? Yeah, well, look, I mean, I think we have a lot of ideas about what can be done with muscarinic-targeted molecules. KarXT, obviously, top of mind for us, but also the programs we have in our discovery pipeline and portfolio. When you look at... There's a number of ways to look at what opportunities are out there, where can KarXT have a medically important impact? And when you look at existing atypical antipsychotics, you know, it's give or take 70-75 million scripts a year in the U.S. About 30-35 million of them are in depression associated with major depressive disorder or bipolar disorder, and about 40 million are in what I would describe as psychosis and related indications: schizophrenia, dementia-related psychosis, autism, and the irritability and behavioral troubles associated with it, and then bipolar mania. Now, Bipolar mania and Bipolar depression, it's a little hard to sort out- Right where that fine dividing line is in terms of use. But what we've demonstrated with KarXT from a robust antipsychotic perspective and a pro-cognitive perspective, plays more into that psychosis, behavioral side of things. So we're obviously already doing schizophrenia, two different indications inside of schizophrenia. We're already doing Alzheimer's. So we think about how do we reinforce the value proposition in those areas, or how do we expand into new areas? I think a pediatric population is an important consideration for us. You know, atypical antipsychotics, particularly risperidone and aripiprazole, which are approved for irritability and autism, have the same risk-benefit considerations as they do in schizophrenia. A lot of long-term side effects, including hormonal and metabolic effects, which are particularly problematic in developmental adolescents and children. I think there's a real opportunity for KarXT to be a step forward in treatment there. So that's something we want to consider. Certainly, we would also consider additional cognitive data collection in a you know, specific targeted cognition paradigm inside of schizophrenia as a way to really reinforce the broad spectrum of benefits of KarXT and would substantially differentiate from current standard of care. We would certainly think about bipolar mania, as well. And I think the consideration is really how you do these things. Right. ... you know, it could be investigator sponsor studies. I think there's a lot of interest in working with KarXT out there in the psychiatric community. It could be proof of concept or phase 2A types of studies that look at generating definitive, statistically powered data, but aren't necessarily full-scale, multi-study registrational programs. So it's a mix of those things. I think you'll be hearing from us in the not-too-distant future, more specifically about what some of those plans are. But you probably lean more towards a registrational program in pediatrics. I think you need that to really establish clearly the efficacy and safety profile to support use there. Something like cognition could be more of a data generation strategy. Got it. You're already indicated for treatment of schizophrenia broadly. How do you reinforce with data and communications, what the value proposition could be? So I think there's a number of factors there, but, you know, there is a huge need that exists for new treatments of psychosis and behavioral disruptions across these indications. And I think the data we sit with today and the mechanistic rationale and basic science support that KarXT can be helpful there. And so, you know, we wanna continue to pursue that broadly. Makes sense. One question on the pipeline, TRPC4/5. Mm-hmm. So, like, what, what is your level of enthusiasm there, and what, what gives you confidence there? And what could we learn about this program in the next 12-24 months, 1-2 years? Yeah, look, I think our level of excitement is high. Yep. And, you know, that comes from the idea that that program, KAR-2618, not so dissimilar to KarXT, could represent a pharmacologically distinct and unique class of treatments. It would be focused on mood and anxiety disorders rather than on psychosis or schizophrenia. And some of the market dynamics and needs I've been speaking about with schizophrenia are largely true in the mood disorder space as well. We have relatively limited pharmacological options. You know, that program has been in over 100 humans for as long as 48 weeks as part of its original development by another company for renal disease. Yes. We've been able to go and demonstrate CNS activity and preclinical efficacy in mood and anxiety disorders with that program. Now we're in the midst of kind of capitalizing all the existing human safety data that exists and designing a program to get back into the clinic, focused on mood and anxiety disorders. I think we'll be in a position to sort of talk more details about that, really, I would say, later, later this year or early next year. You know, it's obviously an earlier stage program than KarXT, but I think it has the potential to turn into something that could be immensely important from a medical perspective and represent a new class of treatments. And that's what we're passionate about, and that's what we want to be working on. Awesome. In last, less than two minutes, my favorite question. 2024, September, I hope you are here, I hope I am here. What would make you look back at the year and say, "It was a great year for us? Well, I think one is I'd like to be negotiating a label- Right ... with the FDA. That would be, that would be nice, sitting here 12 months from now. You know, for us, I think it's about, you know, continuing to push forward on our clinical programs. We have, you know, I think, adjunctive treatment and schizophrenia readout coming second half of next year, so having that imminent at hand, having substantial progress towards 2025 data readouts in the ADEPT program, but also putting a couple of additional new chemical entities into the clinic, 2618 being one of those, as well as things coming out of the discovery pipeline, and really feeling like there's a robust portfolio of development efforts that, you know, we're in a position to take advantage of, given our operational and technical expertise, you know, our balance sheet strength- Mm-hmm ... that we can be pushing forward the next generation of treatments for neuropsychiatric conditions. Great. On that high note, thank you very much, Andrew, for joining us today. Absolutely. It's great to be here. Thank you.