Good morning, and welcome to the Cerevel Therapeutics first quarter 2022 financial results conference call. At this time, all participants are in listen only mode. Later, you will have the opportunity to ask questions during the Q&A portion of the call. Please note that this call may be recorded. I will now hand the call over to Mr. Matt Calistri, Vice President of Corporate Strategy and Investor Relations. Please go ahead. Thank you. Good morning, everyone. We appreciate you joining us for our first quarter 2022 earnings call. On today's call, you'll be hearing from Dr. Tony Coles, our Chairperson and Chief Executive Officer, Dr. Ray Sanchez, our Chief Medical Officer, Dr. John Renger, our Chief Scientific Officer, and Mark Bodenrader, our Interim Chief Financial Officer. Abraham Ceesay, our President, will join us for Q&A. During our call today, please refer to our press release from this morning detailing our Q1 2022 performance, as well as our updated corporate presentation, both of which are available on our website. I would like to remind you that we will be making forward-looking statements that reflect our current views related to, among other things, the potential attributes and benefits of our product candidates and the format and timing of our product development activities and clinical trials. We strongly encourage you to review the information that we file with the SEC regarding specific risks and uncertainties. I will now hand the call over to Dr. Tony Coles, Chairperson and CEO of Cerevel, to provide an overview of our achievements and outlook. Thanks, Matt, and good morning, everyone. Thank you for joining us on our first quarter 2022 business results call. Cerevel aspires to become the premier neuroscience company, and I'm really proud of the progress we've made to date. We've got the pipeline, the people, and the capital we need to deliver innovative solutions for people living with some of the most vexing and difficult to treat neuroscience diseases. These diseases not only affect patients, but their families and society at large. We all know that the unmet medical need is clear. We take a unique approach to addressing that unmet need. We begin with a deep understanding of neurocircuitry or how the brain is wired. We then focus on receptor subtype selectivity and utilize our knowledge of differentiated pharmacology to develop novel therapies through which we seek to transform what's possible in neuroscience. Our results speak to the benefits of our approach. When I spoke to you last quarter, we had just announced positive anxiety data for d arigabat, our selective α2/3/5 GABAA positive allosteric modulator or PAM. Less than a year ago, we announced positive phase I-B data in schizophrenia for emraclidine, our M4 selective PAM. We're forging ahead. We're on track to initiate two parallel, adequately powered phase II trials of emraclidine in schizophrenia by midyear 2022. We continue to execute on our broad, diverse pipeline of neuroscience drug candidates. Finally, we're growing our talented and very experienced team, primarily in R&D, with a deep passion for innovation in neuroscience. Looking specifically at our pipeline, we anticipate five data readouts in 2023. In the first half of next year, we expect to have data from our tavapadon phase III trial in late-stage Parkinson's. We also expect data from our ongoing CVL-871 phase II-A trial in dementia-related apathy. In midyear 2023, we expect data from our darigabat phase II proof-of-concept trial in focal epilepsy, as we announced this morning. In the second half of 2023, we expect data from our two tavapadon phase III trials in early-stage Parkinson's, which would complete what we expect is needed for the registrational package for that drug. We expect to follow this important set of milestones with data from our two recently announced phase II trials of emraclidine, with data results in schizophrenia in the first half of 2024. Cerevel is also in a strong financial position, and we're well capitalized to support operations into 2024. As of the close of the first quarter, we had $551 million in cash equivalents, and marketable securities, to which we added $37.5 million funding in April from the second annual payment of the tavapadon risk-sharing arrangement we entered into in 2021. Cerevel is embarking upon an exciting period of growth, and I'm really looking forward to updating you on our many milestones in the future. I'll now turn the call over to Dr. Ray Sanchez, our Chief Medical Officer, to provide some additional detail about our lead programs and anticipated readout timings. Ray? Thank you, Tony, and good morning to all of you. As Tony has outlined, Cerevel is well positioned to pave new paths in neuroscience. Our pipeline seeks to address some of the most challenging neuroscience diseases and brings forward a new treatment options with enhanced tolerability profiles. As a former clinician, I can attest to the challenges of treating people with schizophrenia, a disease that has rippling effects in all areas of the patient's personal, professional, and family life. The need for better treatment options is what drives us each day. Let's first turn to emraclidine, our M4 positive allosteric modulator. Less than a year ago, we announced positive phase 1b data in schizophrenia, and the results were truly impressive. Both doses of emraclidine demonstrated clinically meaningful and statistically significant antipsychotic effects with no meaningful differences in gastrointestinal side effects, extrapyramidal symptoms, or weight gain compared with placebo. We're very encouraged by those robust results, and we're now moving rapidly into our next phase of development. Importantly, as you can see on slide 15, we're on track to initiate two parallel adequately powered phase II trials by mid-year. Running these two trials in parallel enables us to fully explore the therapeutic dose range of emraclidine while minimizing the number of treatment arms with the hope of reducing the variability observed in clinical trials as well as placebo response. We designed these trials to potentially meet the criteria necessary to serve as pivotal based on what we expect the FDA will evaluate in registrational package. Beyond schizophrenia, we also plan to evaluate this mechanism in other indications in populations, including psychosis associated with dementia. Turning now to darigabat, as Tony mentioned, we have updated the timeline for REALIZE, our phase II proof-of-concept trial in focal epilepsy, which we now expect will read out in mid-2023 rather than the second half of this year. This outcome is based on the use of excluded concomitant medications in the target population as well as COVID-19 disruptions at clinical trial sites. Consequently, in order to augment slower than anticipated enrollment, we have added three additional countries to participate in the trial. Unfortunately, one of these countries was Ukraine. In the time it took to activate these new sites, the war in Ukraine broke out, and we no longer expect the Ukrainian sites to contribute to enrollment in this trial. In the coming months, we do expect enrollment to initiate in the two remaining new countries, Poland and Serbia, which enables us to anticipate data in mid-2023. Last quarter, we were able to share our very encouraging positive top-line data from our darigabat phase I healthy volunteer trial in acute anxiety. These results provide strong evidence of darigabat's potential versus as a differentiated daily maintenance treatment for anxiety-related disorders while minimizing tolerability concerns, in contrast to benzodiazepines. Based on the robustness of our phase 1 data, we're exploring various indication opportunities for darigabat, with the first likely to be panic disorder. Turning next to tavapadon, our D1/D5 partial agonist that we're developing for Parkinson's disease as both a monotherapy and adjunctive treatment to levodopa for symptomatic motor control. We continue to dose in all of our phase III trials, known collectively as the TEMPO trials, and all remain on track with our expected timelines. We expect data from TEMPO-3, the adjunctive trial in late-stage Parkinson's, to read out in the first half of 2023, and data from TEMPO-1 and TEMPO‑2 trials in early-stage Parkinson's to read out in the second half of 2023. Turning to CVL-871, our second D1/D5 partial agonist, which we are currently evaluating in a phase II exploratory trial in dementia-related apathy. We expect data in the first half of 2023. In June of last year, we received Fast Track designation for CVL-871 in this indication, which enables early and more frequent interactions with the FDA as well as the potential for rolling NDA submission and priority review. We are looking forward to interacting closely with the agency in determining the best path forward for developing a treatment in this novel and much-needed indications since there are no currently approved therapies. With that, Dr. John Renger, our Chief Scientific Officer, will speak about our early-stage portfolio and our presentations at medical conferences. John? Thank you, Ray. Good morning, everyone. I'd like to first provide an overview of our earlier-stage clinical and preclinical programs. First, we have an active program to identify an M4 selective full agonist molecule as part of our goal of creating an industry-leading M4 franchise. We believe this novel asset will provide for additional therapeutic indication optionality as we consider the clinical utility of this mechanism of action and its demonstrated potential in treating psychosis. Second, I'd like to highlight our kappa-opioid receptor antagonist program, which continues to progress in our planned phase I single and multiple ascending dose studies. We believe this mechanism of action has a potential to address major depressive disorder and substance use disorder based upon both clinical and preclinical data generated with compounds that target the kappa-opioid receptor. We are also progressing a PDE4B antagonist program, a clinically proven mechanism of action that has seen previous drug approvals in both inflammatory diseases and dermatologic and respiratory indications. This mechanism of action has also demonstrated early clinical activity in the treatment of depressive symptoms in prior proof of concept studies. Our program within Cerevel is directed at creating a CNS active PDE4B selective inhibitor for potential use in major depressive disorder and in CNS inflammatory neurodegenerative therapeutic indications while aiming to avoid the tolerability limitations of GI distress that were associated with prior CNS active non-selective PDE4 inhibitors and limit their clinical utility. Finally, we made a decision to discontinue further investment in CVL-936, our dopamine D3- preferring D2/D3 receptor subtype selective antagonist for the treatment of substance use disorder. This decision was based on the results of a multiple-dose non-clinical EEG study. We continue to build a robust drug discovery engine at our research labs in Cambridge Crossing with additional ongoing discovery stage and pre-IND programs. We are leveraging our differentiated understanding of disease-based neurocircuitry and world-class chemistry to develop and explore the therapeutic potential of small molecules to address major unmet patient needs. We believe our research engine will fuel future innovation for years to come, and we look forward to keeping you updated on our progress on these earlier stage efforts as appropriate. Finally, I also want to emphasize how proud I am of our team's recent presence at medical meetings, which is an important aspect of our journey to becoming the premier neuroscience company. Our teams presented at the American Academy of Neurology, highlighting our progress on our darigabat and tavapadon programs. Subsequently, we also presented our emraclidine data at the Schizophrenia International Research Society Congress. These presentations underscore our belief that we are well-positioned as a scientific and clinical development leader across several neuroscience diseases associated with significant unmet patient need. I'd like to publicly extend my congratulations to our teams for their ongoing commitment to our company and also the patients who are relying on us. I'd now like to hand it over to Cerevel's Interim Chief Financial Officer, Mark Bodenrader, to review our financial performance for the first quarter. Mark? Thank you, John, and good morning, everyone. I'm pleased to provide an overview of Cerevel's strong financial position in our first quarter 2022 financial results. Please refer to this morning's press release for the full details of our financial update. For the first quarter, total operating expenses were approximately $73 million, which includes R&D expense of $55 million and G&A expense of $18 million. As expected, total operating expenses for the first quarter grew over prior quarters, driven by the continued progression of our clinical trials and increased personnel costs to support the advancement of our pipeline. Relative to the first quarter last year, R&D expenses increased by approximately $18 million. This increase was primarily due to the continued advancement of Cerevel's clinical programs for tavapadon, emraclidine, and darigabat, investment in our preclinical and discovery efforts, and an increase in personnel and other infrastructure costs as we expand capabilities to advance our pipeline. We expect our quarterly R&D expense to continue to increase as we plan to initiate the two phase II clinical trials for emraclidine in schizophrenia by mid-year. G&A expense for the first quarter increased by approximately $3.5 million over last year. We also continue to expect our G&A expense to increase as we support the growth of the company, including the progression of our R&D programs and the initiation of commercial planning activities. As of March 31st, 2022, our cash and cash equivalents in marketable securities totaled $551 million. This cash position does not include the additional $37.5 million received in April under our tavapadon risk-sharing arrangement that Tony mentioned earlier. In closing, we remain well-capitalized. We expect our cash resources to fund our current operations into 2024. We look forward to multiple value-creating data readouts over the next couple years, and we continue to think creatively and opportunistically about further strengthening our balance sheet to support our extensive pipeline while pursuing earlier stage clinical programs and drug discovery initiatives. With that, I'll hand the call back to Tony for closing remarks. Thanks, Mark. As you can see, we continue to advance our broad and diverse pipeline and building what we hope will become the premier neuroscience company. Cerevel is at the forefront of the next great frontier in medicine, and it is our daily privilege to work with the aim of delivering new solutions to patients who are in great need. Thank you for joining us this morning. I want to thank our teams, whose dedication and commitment make this possible. In particular, let me extend my deepest gratitude and appreciation to the clinical trial participants and the investigators who contribute to the development of these important therapies. With that, operator, we can now open the call for questions. Thank you. As a reminder, to ask a question, please press star one on your telephone keypad. To withdraw your question, press the pound key. Please stand by while we compile the queue and roster. Your first question comes from Cory Kasimov from JP Morgan. Your line is open. Hey, good morning, guys. Thank you for taking the questions. I've got two for you, one on darigabat and one on emraclidine. For darigabat and the epilepsy trial, can you comment on just on how much you're hoping to enroll, how many patients you're hoping to enroll in Poland and Serbia, and your confidence in generating high-quality data in those regions? For emraclidine, you know, with the pending phase II or possibly pivotal efficacy studies being 10 weeks in duration and then, of course, having that open label extension safety study for 52 weeks, do you have a sense as to how much safety data and duration you may need in the event the efficacy studies do enable a filing, as that seems to clearly be the future rate limiting step? Thanks a lot. Okay. Good morning, Cory, and thanks for the questions. Ray, I think I'll ask, actually ask you to get us started here with Cory's first question about darigabat, the enrollment numbers and the quality of data from Poland and Serbia. Terrific. Good morning. Good morning, Cory, and thanks for that question. We are looking at, we've activated six sites in Poland and five sites in Serbia. We're still determining the number of patients that those two countries can enroll. What I can tell you is that the reason that they were chosen is because they generally historically have actually provided very good quality data, and so we're hoping that the same will be true in the data that they generate moving forward. But in terms of the number of patients that they will enroll, we're still working with the sites on that, and they'll start in the next few weeks enrolling patients into the trial. Ray, the second question was about emraclidine and the 10 weeks duration. Can we review the general design for the two phase II studies for emraclidine. I think Cory's question was would we have adequate safety data that would support- Right. Patient package? Yes. Cory, as you know that we are conducting, starting very soon, two six-week pivotal trials in patients with acute schizophrenia. We also need for registration, as you're outlining correctly, long-term safety data and per ICH guideline, we would need a minimum of 300 at six months and 100 exposed at one year. Our hope is that we can exceed, of course, those numbers. That is what it would be needed in addition to the two positive phase II trials that really characterize the dose range for registration. Okay. Very helpful. Thank you. Sure. Thank you. Thank you. Thank you, Ray, very much. Operator, we will take the next question. Thank you. Your next question comes from Michael Yee from Jefferies. Your line's open. Hey, good morning. Thank you, Tony, for the update, and thanks for the question. With respect to emraclidine, can you shed some light on the registration enabling studies, for example, the blood pressure monitoring study, which I think is ongoing? I know there's been various questions about how to put that study into context. I was wondering if you could right size our expectations for what you would expect that study to show, the relevance of that study and even such details as, is there a placebo arm, and is that important to have a placebo arm or it doesn't really matter? Maybe just talk a little bit about that study. Thank you. Okay. I'm gonna ask Ray to make a few specific comments, but let me offer a couple of points by context. This is a standard clinical pharmacology trial that the agency will require for registration purposes. We are working to comply with the agency's outline for what they'll be looking for. The primary purpose, as you certainly know, and we'll remind everyone else, is to assess a sustained effect on blood pressure. We did see trends in increases in blood pressure in the phase I-B study, but those increases were not sustained. This is, of course, to give the agency assurance that we won't have a significant effect going forward. Trial is going quite well, and Ray, maybe you'd offer some additional specific comments. Michael, I just wanted to set the context for the ordinary course of practice for this particular trial. We're working to have everything ready for registration, if these data are supportive of that. Ray, what else would you add? Sure. Thank you, Tony. I think you answered that well. Also Michael, just to give you some relevance, this is an eight-week trial that has 150 patients that are participating in it, looking at doses of 10 mg and 30 mg, so the low dose and the high dose, with the objective of assessing a sustained, as Tony mentioned, effect on systolic blood pressure over the eight weeks. It's 90% powered to rule out 3 mm Hg or above change from baseline. We're encouraged as the enrollment is going very well. We do expect the results to read out in the fourth quarter of this year. I think importantly, as Tony mentioned, that this is a phase I trial like other phase I trials that is required for FDA guidance for registration and labeling, most importantly. We will disclose those results at the appropriate time when they're available. Let me emphasize something I think you alluded to before. Even if there was a small signal or not, your point has been that may or may not be totally relevant for patients, and it's more of a clinician labeling thing. Is that correct? That's correct. As you know, this is a trial that is not gating to our being able to pursue the larger trials that we're starting soon. Again, like, you know, drug-drug interaction studies, like food effect studies, this is really a study that will inform labeling for practitioners to understand the sustained effect on blood pressure if there is any. Thank you. Thank you, Mike. Thank you, Michael. Operator, we'll take the next question. Sure. Your next question comes from Paul Matteis from Stifel. Your line's open. Hey, thanks so much for taking the questions. On the ambulatory blood pressure monitoring study, I feel like one important detail that hasn't been talked about much is that some of the data you presented so far has been close to Cmax, whereas I think that study is doing 24-hour monitoring. Can you put into context, if we're looking at blood pressure changes over 24 hours, how much more modest are they on average versus the data that we've seen so far? I guess, am I right in assuming that they're more modest? Any numbers you could put to that, I think would be interesting. Just on the kappa opioid target, I was wondering how you view the totality of the data we have so far for major depressive disorder. I know there's been a couple studies. One was a publicly funded study that looked all right, one more recent data point from J&J. Just curious how you would sort of contextualize that in your confidence in moving forward. Thank you. Okay. I think, Ray, if you would, start on the question about blood pressure observations from the phase I-B trial, and then I think we'll have J.R. continue with that, particularly on the Cmax point that Paul's raising. Then J.R., if you'd lead right into the KORA point, that would be great. I appreciate the question, Paul, because we do wanna feature the early-stage pipeline, and we're excited about the KORA opportunity along with all the later stage stuff we're doing. Ray, if you'd start and then toss it to J.R. Yes. Good morning, Paul. If you recall that during the six-week trial, the phase I-B trial, that at six weeks, versus placebo that the average systolic, diastolic blood pressure and heart rates were all very similar to placebo with really no concerns raised there. Really what the agency, and rightly so, is not so much the transient changes that you see around Cmax, but really the long-term sustained effects on systolic blood pressure, which really have the most cardiovascular impact. Consequently, the trial is designed as you mentioned correctly, to look at a 24-hour monitoring of blood pressure over the 8 weeks at certain times. We'll do it at baseline. We'll do it at weeks four and eight. The change from baseline at week eight is the primary endpoint. Again, the core objective being the sustained systolic blood pressure. It's eight weeks. We're encouraged by that because at six weeks, as I said before, we saw minimal effects. It's really around the average sustained effect versus what we see around Cmax at any given time in moment. Paul, does that answer your question? It does. Thank you. Thank you. J.R., would you add anything to that? If you could, pick up on the core question as well and our thoughts on the totality of data in major depressive disorders. Sure, Tony. Thanks. Yeah. I'll just add one other note, and I think Paul, part of your question may have been the transient not over multiple days of dosing, but the transientness that we've seen even within a 24-hour period. If you think back to the study design, we had done a BID dosing at 20 mg and a once a day dosing at 30. Subsequently to capture the Cmax, we had to collect blood pressures twice a day, Cmax to be covered at both the BID doses. You know, we did see that it was maintaining a transient effect with a single dose data. I'll just add that we can confirm what we've seen previously in a clinical setting and in the preclinical studies from that. I'll transition over now to the question you had about our confidence in KORA and the recent you know the previous study that was done in depression and the recent J&J study that was where the results were posted in the EMA clinical you know version of ClinicalTrials.gov. Yeah, I think that those two studies that you mentioned particularly the J&J study are very you know kind of guiding for us in how we're thinking about taking the program forward. As you know, there was also a publication from J&J that was a very well-done paper where they actually talked about how they picked their doses and the receptor occupancies and then how they approached the translation, you know, the translational piece of understanding receptor occupancy and actually publishing that data prior to the results that they'd seen in the depression study. Obviously, this is guidance for us. We won't necessarily follow exactly what they did, but we're really confident about how they picked their doses to go forward. We were really, you know, kind of excited to see the data that they got in the depression study. I think we're excited about it, but I think we will also have our own spin on how we proceed, based on what we think we understand about the circuitry involved here and the patient need. Very good. Thank you. Yep. Thank you, Paul. Thanks, J.R. and Ray. Okay, operator, we will take the next question. Thank you. Your next question comes from Douglas Tsao from H.C. Wainwright. Hi. Good morning. Thanks for taking the questions. Maybe just sticking to the early stage pipeline, I was just hoping maybe you could talk a little bit more about the M4 program. Just given what we've seen with Emraclidine, what you're trying to accomplish with those molecules and what does that potentially, you know, sort of open you up to accomplish clinically? Yep. Let me, I'm gonna ask J.R. to address that, but let me make a couple of comments, Doug. You know, from all of my years, at least as a marketer and a commercial guy, it's always been advantageous to have more than one entrant with the same mechanism, particularly if it's, if the mechanism is effective. I think this gives us an opportunity, assuming we can generate positive clinical data with the M4 agonist, gives us the opportunity to cover an even greater number of potential indications in the neuroscience space. I think about this as a complement to what we're doing with emraclidine, certainly in schizophrenia and potentially even the dementia-related psychosis, which is very much of interest to us. If we can add a third and potentially a fourth indication by advancing an M4 agonist that might have the potential to work in other related disorders, that would be really attractive. J.R. can talk specifically about the mechanism, but I just wanted to offer that higher level kind of strategic franchise vision that we have for advancing multiple entrants and multiple with multiple related mechanisms. J.R., please add some details to that. Sure. Thank you, Tony. Thanks for the question. Yeah. I think that a couple of things are relevant here and kind of the background. First of all, you know, with the ability to have a really exceptional group both in our in- vivo biology group as well as our Med Chem group, what we've done is made a wide range of different molecules that are M4 selective and have various types of pharmacology. Also, you know, working very closely with the clinical group, what we've really carefully considered is the fact that when you look at the potential for a new mechanism in treating psychosis and you look at the current treatments that are used, you know, and you start to think about various indications you can pursue, I think that there's some indications that are very obvious for a PAM. What we've seen is the kind of results that are outstanding for looking at psychosis in schizophrenia patients. We know previously that there was a very strong rationale for believing that psychosis associated with dementia in the Alzheimer's population is another one that we're very interested in. You know, if you think about a clinical practice, what you actually see is that there are certain types of psychosis where even with the classic typical atypicals, the clinical practice is to actually start at very high doses at the initial treatment to offset, for instance, a manic break, in patients that have, you know, certain severity of disease. When you think about the potential of this mechanism being one that hasn't required titration to date with emraclidine, and you're thinking about clinical practice and even how typicals and atypicals are used at higher doses in certain populations, and knowing what we've characterized pre-clinically in our models, we believe that there's a real opportunity to expand on indications with a full agonist that would really from the get-go really hit as hard as possible the M4 receptor to provide clinical benefit. We think that with a full agonist, what we can do is actually pursue some of those optional indications that weren't kind of the first layer indications that we're going after with emraclidine. To help us really build a franchise around what we've learned on this mechanism, its tolerability, and when you have M4 selectivity, how important that is that you can start at a starting dose without titration, particularly in the most severe types of patients with psychosis. We see a real opportunity here. Because we have that opportunity to make new molecules and characterize them and show how they differentiate pre-clinically, based on the research labs that we have here at Cambridge Crossing, we think we have a real opportunity to build upon the science that we've been leading in with the M4 selectivity and create new opportunities to actually build a franchise here, not just a single asset, as Tony was saying. Thank you. Okay. Great. Thank you. That's very helpful. Thanks, Doug. Yep. Thanks, Doug, for the question. Operator, we'll take the next question. Sure. Your next question comes from Madhu Kumar from Goldman Sachs. Hi, this is Omari on for Madhu. We have a couple questions. Can you provide any color on the target population you're looking to pursue for darigabat anxiety? And then second question on the epilepsy trial pushback, just to clarify, there's nothing about trial design that's changing, such as total patient numbers? Yes, thanks. What we said in the prepared remarks for darigabat anxiety is, we are looking very closely at panic disorder. That seems to be one of the anxiety subtypes where there could be a potential role for darigabat. Our teams are studying that very carefully. No, there are no clinical trial changes for the epilepsy study. This is just a matter of getting all the patients into the trial, getting them processed and analyzing the data. No new update in trial design. All right. Thank you. Okay. Thank you. Operator, we'll take the next question. Sure. Your next question comes from Matthew Harrison from Morgan Stanley. Hi. Thank you for taking our question. I'm Won Jung online for Matthew. We have two questions. One is about emraclidine. Is there any other non-clinical work still needs to be completed, which could have any impact on phase II or even relative phase III preparation? The second question is about CVL-871. How robust are you expecting the signal could be? That could be just a trend you could envision or you expect a clearer picture of efficacy? Okay, good. J.R., would you address the amount of non-clinical work that's remaining on emraclidine? Ray, I'll get you to talk about CVL-871. Sure. Thank you, Tony. Thanks for the question. Yeah, there is additional work that is ongoing. We've actually started studies. As you know, carcinogenicity studies that are two years in duration are part of a required registration package. Those are typically the longest studies that have to be completed. We actually pre-invested in getting those earlier to take them off of the critical path. Obviously, when we complete these next two studies that we talked about starting in a very short time period, one of the things we'll do is go back to the agency with our package. One of the things that we will do is determine whether or not they feel that the preclinical package will support registration, and we can get any additional feedback at that time if they think that there's additional studies. We do have a very experienced preclinical tox group, and we've done a lot of pre-investment in this program to make sure that we can move as rapidly as possible. You know, thinking kind of what is standard fare has been addressed. There may always be additional questions that the agency might have, but we'll be able to answer those in time that we can get those studies done to make sure they're not on critical path. I would say that we have it well in hand and the plan is in place, but there's always an opportunity for the agency to give feedback, and we'll respond accordingly. Thank you, J.R. Ray, why don't, if you can, let's just talk. I think the second question has to do with efficacy outcomes from the CVL-871 trial and the clinical tool we're using to measure efficacy there. Right. Good morning. As you know, apathy is the leading neuropsychiatric symptom associated with dementia, and it's one of the strongest symptomatic predictors of disease progression. We see great utility in this D1/D5 partial agonist that operates in areas of the brain that operate under lower dopaminergic tone. Our goal really is, one, to conduct, which we're doing now, phase II-A trial that we're working very closely with the agency on to better understand the utility of this therapy in this population. We're conducting this 12-week trial with 75 patients looking at doses of 1 mgilligram and 3 mg, which achieve 50% and 80% receptor occupancies, and looking at a variety actually endpoints and scales. There's no primary endpoint per se, but it's really truly an experimental trial, to give us an understanding using a variety of scales that have been historically used to understand apathy, but also have been used in the ADMET trials with methylphenidate in the past. When these data will read out in the first half of 2023, we'll look at these data. We'll work with the agency to look at what kind of validation work will need to be done in order to then progress to the later stages of development. The good news is that, as I mentioned earlier, we received Fast Track designation from the FDA, which allows us to work very closely with them, in order to assess which endpoints would be viable and what the path forward would be since there are no approved therapies. Very good. Okay. Thank you. Okay. Very, very good. Okay, operator, we will take the next question. Thank you. Your next question comes from Esther Hong from Berenberg. Hi. Thanks for taking my question. On darigabat, I was wondering if the FDA's provided any guidance regarding the study design. Have you spoken with them about the anxiety disorder? Was wondering when we could expect patient enrollment in the phase II trial for anxiety. Thanks. Okay. Thank you for the question. Ray, can you talk about our planning work and how we're thinking about the next steps for darigabat anxiety? Right. As I mentioned earlier, that our first likely pursuit will be in panic disorder, which is the second highest anxiety disorder after generalized anxiety disorder, obviously stemming from the phase I proof of principle trial. We do plan on meeting with the agency since, of course, you know, they change their thought process over time. These trials historically have been fairly prescriptive, 10-12 weeks in duration, looking at panic attack frequency and so forth. We just wanna make sure that the agency's views are still aligned. Yes, the process that we'll be following will be to look at the historical precedence, meet with the agency to ensure that the path forward is clear. We'll of course disclose that when we internally have that clarity as well. Great. Thank you. Great. Thanks, Ray. Operator, we'll take the next question. Again, to ask a question, please press star one on your telephone keypad. There is no further question this time. I would like to turn the call over back to Mr. Tony Coles for closing remarks. Very good. Thank you. Thank you guys for joining us. As you can see, there is, as always, a lot going on here at Cerevel. Really good progress that we're making in the later stage pipeline. A lot of very exciting data readouts that we're expecting in the months to come. As you well see both for KORA, as well as for the M4 agonist, some very interesting early stage work that will complement what we are advancing rapidly towards the clinic and towards registration. The team's very focused on creating value. We've got the capital to do that, and we really appreciate you guys listening today, and look forward to our next update with you. Thanks for joining the call, and everyone enjoy a great day. Thank you. This concludes today's conference call. Thank you all for joining. You may now disconnect.