Cerevel Therapeutics Holdings Inc
NASDAQ:CERE
Earnings Call Analysis
Q3-2023 Analysis
Cerevel Therapeutics Holdings Inc
Cerevel Therapeutics is steering through an optimistic phase, marked by a strong financial position and advancements in their neuroscience pipeline. A recent capital raise in October, amounting to $499 million, coupled with their third quarter's end balance of $758 million, has shored up Cerevel’s operation funds well into 2026. This bolstered balance sheet underpins their burgeoning research and promises continuity in their pursuit of novel treatments. The third quarter of 2023 saw the company incur operating expenses worth $111 million, broken down into $85 million on research and development and $26 million on general and administrative expenses.
Cerevel maintains a disciplined approach towards its clinical developments, balancing meticulous patient and site selection with the challenges inherent in neuroscience research. They are actively working on various initiatives to address enrollment challenges for trials, ensuring that the trial protocols and site operations adhere to quality standards. These efforts are geared towards maintaining the integrity of trial results, evident from the steady progress of emraclidine enrollment for treating conditions such as schizophrenia and their scrupulous strategies in mitigating placebo responses across studies.
Cerevel is capitalizing on its rich pipeline, featuring various potential therapies like emraclidine, which is pegged as a best-in-class muscarinic agent with a simplified dosing regimen and tolerable profile. The company eyes multiple indications, including major depressive disorder and substance use disorder, where they see an opportunity to combine kappa and Mu opioid receptor activities to provide differentiated patient benefits. Encouraging developments are being shared about their focused programs in schizophrenia as well, although decisions on adjunctive treatments will ride on the more profound understanding of emraclidine's profile in the condition.
Cerevel's leadership is riding the wave of a strong financial backbone, hoping to marry this advantage with their robust portfolio of neuroscience drugs. With enough resources to sustain operations into 2026, the team is positioned to focus entirely on bringing their therapeutic candidates to fruition. The anticipation of mid and late-stage clinical readouts signals a bustling time ahead for the company, potentially leading up to two New Drug Application (NDA) filings, marking a significant milestone in their journey towards addressing complex neuronal pathologies.
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Good morning, and welcome to the Cerevel Therapeutics Third Quarter 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 Matt Calistri, Vice President of Investor Relations.
Thank you. Good morning, everyone. We appreciate you joining us for our third quarter 2023 earnings call. On today's call, you'll be hearing from Ron Renaud, our President and Chief Executive Officer; Dr. Ray Sanchez, our Chief Medical Officer; Dr. John Renger, our Chief Scientific Officer; and Dr. Susan Altschuller, our Chief Financial Officer. During our call today, please refer to our press release from this morning, detailing our third quarter 2023 financial 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 filed with the SEC regarding specific risks and uncertainties. I will now hand the call over to Ron Renaud, President and CEO of Cerevel to provide an overview of our achievements and outlook.
Thanks, Matt, and good morning, everyone, and thank you for joining us for our third quarter 2023 business results call. I'm pleased to be with all of you today to review our third quarter results and to discuss how we're preparing for what we expect will be an exciting 2024. Let me start with some high-level thoughts on how the management team is thinking about and planning for the future of Cerevel. To begin, we believe this organization has one of the most robust neuroscience pipelines in the industry. And next year will be a pivotal one for Cerevel as we look forward to multiple mid- and late-stage readouts across 3 different assets in 3 different indications. Our recent capital raise significantly bolstered the balance sheet, extending our runway into 2026, well over 12 months beyond all of our expected data readouts next year. As an organization, we have leads our focus on execution and maximizing the value creation opportunities for each of our lead assets. Our ongoing clinical trials are progressing well, and we expect to deliver data for tavapadon, darigabat and emraclidine on the time lines we laid out last quarter. We are planning for success in proactively preparing to potentially file 2 NDAs in 2025 in tavapadon and emraclidine if data are positive. Furthermore, we are diligently exploring life cycle opportunities for our lead programs and other indications. Let me now provide an overview of our lead programs. Emraclidine, our M4 selective positive allosteric modulator, or PAM, is currently in development for schizophrenia and Alzheimer's disease psychosis as a once-daily medicine without the need for titration. Emraclidine is the potential next-generation antipsychotic with a novel mechanism of action that targets BM4pathway. By selectively targeting M4, we believe emraclidine may reduce psychotic symptoms without challenging side effects of current antipsychotics. Our 2 potentially registrational trials in EMPOWER-1 and EMPOWER-2 are enrolling well, and we expect data to read out in the second half of 2024. We are excited about the potential of emraclidine and the benefit it may bring to patients with schizophrenia who have not seen innovation in decades. Moving to tavapadon the first D1/D5 partial agonist in development for the treatment of Parkinson's disease. We expect our TEMPO-3 adjunctive trial to be our first data readout in the first half of 2024, with the TEMPO-1 and TEMPO-2 monotherapy readouts coming in the second half of the year. Building on our excitement for this program, we are pleased to announce that we will host a tavapadon investor webcast on December 11, during which we will explore this novel mechanism and its potential to address patient needs in greater depth. We believe there is a significant opportunity in Parkinson's disease to deliver sustained motor control with a favorable side effect profile. And finally, let me turn to Darigabat our selective alpha-2/3/5-selective-GABAA, currently in development for both focal epilepsy and panic disorder. As we recognized epilepsy awareness month in November and the 3.4 million people living with epilepsy in the United States, we are hopeful that we can bring forward a new treatment option for people living with this difficult disease. Our Phase II REALIZE trial in focal epilepsy to be our second readout of 2024 coming midyear. We've also initiated our ADAPT trial, a Phase II proof of concept trial in panic disorder. Behind our mid-to-late stage pipeline, is an innovative discovery engine that is focused on bringing forward additional novel mechanisms to address neuroscience diseases. And we look forward to providing greater detail on those programs, including our capital opioid receptor antagonist as we make further progress. I'm quite excited about all that we're doing here at Cerevel. And all that has to come for our pipeline and the potential benefits we hope to bring to patients. We are well positioned as we go into 2024 to truly transform what is possible in neuroscience. With that, I'll now turn the call over to Dr. Ray Sanchez, our Chief Medical Officer, to provide some added color about our lead programs. Ray?
Thank you, Ron, and good morning, everyone. I want to echo Ron's sentiments about the excitement around our pipeline. As a former clinician, I can tell you that I am energized by the potential we have here at Cerevel to make a meaningful difference in the lives of patients with neuroscience diseases. Beginning with emraclidine our Empower program is advancing and data are expected in the second half of 2024. Preserving data quality while mitigating placebo response risk remains the utmost priority for these trials, and we are pleased with our recent efforts to reinvigorate enrollment. As a reminder, EMPOWER-1 and EMPOWER-2 are 2 adequately powered 3-arm trials that include adults living with schizophrenia and experiencing an acute exacerbation of psychotic symptoms. We designed these trials to potentially meet the criteria necessary to service pivotal trials based on what we expect the FDA will evaluate in a registrational package. We're also enrolling our 52-week open-label safety extension trial in EMPOWER-3 and prioritizing the completion of non-clinical and clinical pharmacology studies to accelerate a potential registrational package for maracalgenos schizophrenia. We believe in emraclidine has tremendous potential in other disease areas and plans for further development are underway. In Alzheimer's disease psychosis, or ADP, our Phase I healthy elderly volunteer trial is ongoing, and the results of this trial will guide our clinical development plan as we advance important indication with a substantial unmet need. Turning now to tavapadon, our D1/D5 partial agonist in Parkinson's disease. Our Phase III trials known collectively of TEMPO trials are ongoing along with the corresponding open-label extension in which we are encouraged by a greater than 90% rollover rate. We expect data for TEMPO-3 in the first half of 2024, with data for TEMPOS-1 and 2 coming in the second half of 2024. We look forward to walking you through the scientific rationale and prior data for tavapadon as well as its clinical potential during our investor event in December. With darigabat, or selective-GABAA PAM, we believe there is potential for both antiepileptic and angilotic activity comparable to benzazepine with an improved side effect profile. Unlike benzodiazepines, which are only used for acute episodes due to tolerability, abuse potential and other debilitating side effects to darigabat's novel mechanism of action and anticipated favorable tolerability profile provides the potential for chronic dosing. We expect results from our Phase II REALIZE trial in focal epilepsy in midyear 2024, and we are encouraged by a continued high rollover rate into the realized open-label extension. Beyond focal epilepsy, our ADAPT Phase II trial panic disorder is currently underway. A new drug has not been approved in panic disorder in nearly 20 years, and we are excited about the potential of providing darigabat as a daily chronic therapy to patients in need. Cerevel's mid to late-stage pipeline has the potential to bring forward numerous treatments to address some of the most devastating neuroscience diseases, and I am so proud of the team that is working diligently to make the potential -- this potential a reality. With that, let me turn it over to Dr. John Renger, our Chief Scientific Officer, to provide an update on our early stage portfolio. John?
Thank you, Ray, and good morning, everyone. I'm very pleased with the progress we've made in discovery research and early clinical development here at Cerevel. Today, I'd like to focus on our CAF opioid receptor antagonist or core program, also on a CVL-354. We have completed both our single and multiple ascending dose trials in which CVL-354 has been generally well tolerated. Further, we currently believe we will be able to interrogate a range of receptor occupancies in both the Kappa and [indiscernible] opioid receptors. We believe and anticipate we'll be able to explore multiple indications of interest such as major depressive disorder and substance use disorder. Our ongoing Phase I preceptor occupancy trial will clarify both Kappa and new receptor penetration displacement to further characterize selectivity across the compound exposures. We are encouraged by the potential impact of this asset, and we look forward to providing more updates on our plans in the near future. Beyond KORA, we have a growing number of programs, some in issue within our labs and exclusively developed here at Cerevel, which we continue to progress, including our inforce selective agonist, a PDE4D-sparing antagonist and a selective TIM-175 potentiator program. We will provide further updates and plans for these specific programs as appropriate. With that, I'm going to turn it over to our Chief Financial Officer, Dr. Susan Altschuller, to review our financial performance for the third quarter. Susan?
Thank you, John. Turning to our financials. In October, we opportunistically bolstered our balance sheet with a $499 million capital raise, providing strong validation of Cerevel's potential from both new and existing high-quality investors. This additional capital, along with the roughly $758 million in cash, cash equivalents and marketable securities, we ended the third quarter with, will support our operations into 2026. Turning to the third quarter of 2023. Operating expenses were approximately $111 million, comprised of $85 million of research and development expenses and $26 million of general and administrative expenses. Looking forward, our financial strength enables us to focus on execution and provides optionality to maximize the value of our pipeline. That said, we will take a disciplined approach to resource allocation as we further build our pipeline, advance our lead assets and prepare for 2 potential NDA filings in parallel. With that, I will hand the call back over to Ron for his concluding remarks.
Thank you, Susan. At Cerevel, we believe we have an unparalleled pipeline in neuroscience with multiple mid- and late-stage readouts across 3 different assets expected next year and the balance sheet that provides us with past runway into 2026. We are focused and aligned on executing our trials, delivering high-quality data next year, and as Susan mentioned, preparing for 2 potential NDA filings. These are exciting times at Cerevel, and I'm so proud to be leading this organization. I want to offer my sincere appreciation to all of our employees who work tirelessly every day to deliver on Cerevel's mission. And I also want to thank our investigators and participants in our clinical trials, without whom none of this would -- none of what we seek to achieve would be possible. With that, let's open the call for questions.
Thank you. [Operator Instructions]. One moment for our first question. And our first question comes from Michael Yee of Jefferies.
Thanks for the question, and thanks for the update, Ron. I know everyone's focused on execution. Two questions. First on emraclidine. Obviously, since last quarter, there was some concern about some of the timeline changes. Can you maybe just describe what initiatives that give you the confidence that things are progressing on time and specifically maybe for the team, what the right patients are the right site selections are that gives you the confidence on executing on that enrollment? And the second question is on epilepsy. There's actually a bunch of competitor readouts happening. And maybe you could help us understand about the placebo arms and what things you're integrating into your study that might help us give us confidence there because that has historically been an issue, and I know that's a concern for others as well.
Yes, sure. So let me take the first part of your first question, and then I'll let Ray address the second part in terms of site selection from emraclidine and then the placebo work on our epilepsy study. So look, as we mentioned last quarter, we are focused on trying to address the challenges that we saw with some of the enrollment issues that we had. And look, we're doing that with boots on the ground. I've spent time at sites with Ray and the team and the leader of our clinops and clinical development groups and really working with the site to see what's going on. And I think we're quite pleased with the progress that we've seen so far. And that's why we can stand by the guidance that we've given here in the quarter. That all said, our focus will always remain on ensuring the quality of the data, and I think that gets to the second part of the question. We're going to maintain -- continue to maintain rigorous site selection and focus on our placebo variability reduction strategies. But I'll let Ray address how we think about the sites and how we think about all of those things as we continue to make progress here and also talk about our placebo group in the epilepsy studies.
Thank you, Michael. So as you know, Michael, I've historically defined what does a good side look like. It's really the access to the right patients and having good solid raters. And that really determines for the most part, the success of the trial. So that's where we have been achieving and are continuing to try to achieve. But if you look at when we started the emraclidine trials, they started quite robustly for the first year and then the momentum slowed down in the spring of this year. What we've learned is how to manage the competitive landscape a bit more effectively. And to that end, we're seeing increased momentum in our enrollment without, as Ron mentioned, diluting the data quality in any way. So again, having very close communication with the sites ensuring that the radar recertifications occur frequently and continuing that communication ensures us that we have the greatest fleet of success moving forward. In terms of epilepsy and the placebo responses, as you know, that we are seeing placebo response in indications like spinal cerebellar ataxia and epilepsy, and that would surprise many. But we are also taking the same aggressive approach and dedicated approach to mitigating the placebo response in our oceans in epilepsy trial by having placebo mitigation protocols at each site, but also, it's about patient selection, making sure that the right patient profile is included in these trials and really monitoring the data -- the blinded data to ensure the quality is there. So all taken together, there will be approach we're taking to help epilepsy to reduce placebo response is really the same approach we've taken to all our trials to reduce placebo response, and we're confident that we're positioning these trials for the greatest likelihood of success.
Thank you. One moment for our next question. And our next question comes from Paul Matteis of Stifel.
I honestly wanted to ask a really similar question on emraclidine, and that is related to this recent TAAR-1 setback and the implications of that. I guess when you look at that data and the huge placebo response they saw and anything else within those results, what sort of metrics are you tracking specifically on a blinded basis in the emraclidine studies beyond the obvious, like just changing pans that I guess, today give you confidence that you're getting the patient and site quality that you intended or hope to? And then on the Kappa program, I wanted to ask a quick question for John. Just in the [indiscernible] both site really high selectivity per Kappa over Mu. What's behind your thesis that Mu might actually contribute to efficacy and some of the conditions that you plan on pursuing.
Yes. I'll let me Ray take the first part.
So Paul, good question. So we review the data on a monthly basis and sometimes more frequently, but it is blinded. So really, in terms of data quality, we want to ensure that all of the parameters that we're assessing are correct and that they're not conflicting. And so, if that occurs, we obviously intervene at the site level to make sure that the raters are doing what they need to do or they need to have a refresher and that validation, of course, occurs frequently with the raters. In terms of having the confidence that we're mitigating that placebo response, it's really around other measures that I mentioned earlier, in Michael's question, in terms of looking at the right patients and how do we do that? We have an independent committee that really looks at the patient qualifications to ensure that they meet the criteria for the profile that needs to occur for them to be enrolled in the trials. So -- and then we have a placebo protocol at each site that allows us to standardize the way we actually approach each patient at every site to increase the likelihood of success and mitigate that placebo response. So really, we've taken the learnings from so many years as well as the advice from key advisers who understand placebo response and have infused them into our programs. So we're confident that we're taking all measures to ensure that, that placebo response is mitigated. We're also limiting the number of countries, limiting the number of sites, all of which contribute to a placebo response. If you look at the trials that you've mentioned, the recent trial that over 6 countries, over 35 sites in those trials. And so, all of that contributes to variability, everything that we're trying to minimize to ensure the greatest likelihood of success.
Sorry, Paul, and thanks for the question on Kappa Oploid Receptor antagonist. So to your question about what does Mu provide in terms of potential therapeutic benefit in indications. And so, as an example, what I would do is point to opioid withdrawal syndrome patients. And so if you think about what you do, you want to achieve potentially with our tour profile. What we can do is we can go through a receptor occupancy range at Kappa where we can have selectivity to Kappa, but if we continue to go up the receptor occupancy curve and exposure curves, we can bring in [indiscernible]. And so, why does that provide something that us that seems exciting is because what you can get is a therapeutic benefit from Kappa and what we believe the potential there is, is to reduce things like the Q industry and statement data that you see in the preclinical models where you can remove some of the things that would cause relapse in patients that are they undergoing withdrawal or undergoing abstains from use of opioids, but if you think about what you're actually trying to achieve in the long term, it's also reducing the potential for exposure to Mu agonists. And so, if you think about how you could approach that population, you can actually begin with a lower dose range being the benefit of the Kappa without having any kind of Mu antagonism that might induce withdrawal symptoms. And then as the patient progresses, you can actually increase the dose that you actually bring in the Mu antagonism potential. What that does is it has the ability to block the opioid activation, if there is an exposure to an opioid in the future for that patient. So let's say they have a relapse, they take an opioid agonist at that point. Having an antagonist could benefit that patient population, both as a safety measure in terms of blocking activation with an opioid, so you could present the potential for harm but you can also potentially, depending on what exposure they get to what opioid, you can actually prevent the rewarding benefit. And so, you can imagine where you would start the patient going through the phase of withdrawal, starting with more of a Kappa selectivity dose range. And what you could do is build up that dose range over time so that if there is an exposure, you have the protection of having a Mu antagonism benefit on board in that same patient. So that's how we're thinking about it.
Thanks a lot.
Thank you. One moment for our next question. And our next question comes from Muhi Penal of Wells Fargo.
And thank you for having an uneventful quarter. Really appreciate and comment on the financing. I have 2 questions. One is on tavapadon. In our checks, doctors are suggesting that the dopamine agonists are a little bit outn of fashion , they are not used as much. So could you talk a little bit about how you're thinking about the bar for success clinically, not just starting benefit, what it should be? And then second one, can you remind me darigabat -- about darigabat, what was the reason for slow enrollment and how you are mitigating that?
So Mohit, thanks for that question on Tavapadon. If you think about the novel mechanism of tavapadon being a D1/D5 partial agonist that subpectively targets those receptors of the direct agostriatal pathway really gives us the confidence that it's going to be a transformative therapy and symptomatically treating Parkinson's disease. Clinically, we've designed a program to show the benefit that's both the monotherapy and as an adjunctive therapy in the monotherapy, 27 trials looking at the UPDRS, Part 2, which looks at the daily functioning and Part 3 that looks at the motor symptoms, and that's the primary endpoint and change from baseline is the primary import on that. So to show really the benefits on not only motor symptoms, but the quality of life is impacted by motor symptoms. For the adjunctive trial, which is our first trade readout in the first half of next year, we're looking at the benefit of tavapadon as the best adjunctive treatment with levodopa to decrease the off-time, but importantly, increase the on-time without troublesome dyskinesias, which is the primary end point and really what's clinically relevant. So that's how we are thinking about that program. And really, we're thinking of it as really fact-bone therapy, meaning that when the patient is first diagnosed as being the best therapy to initiate patients on and then when levodopa needs to be introduced as the best adjunctive treatment. So we're hoping that if the results read out as we expect that they will next year that we will then proceed to file that NDA and give patients a transformative therapy for symptomatic treatment of Parkinson's.
Mohit, can you repeat that question?
Yes. I mean so the question was, can you remind what was the reason for slow enrollment in the beginning? And how are you trying to mitigate that? I think it was more to do with moving the fact that you were taking patients off the background medication, right? I mean what's the issue there?
No. So there are a couple of reasons for the enrollment issues with the epilepsy program. Remember, these are patients who are drug resistant. -- are at least 1 and no more than 3 antiepileptics, they continue on those therapies at a static dose. So those that's not changed. One of the challenges that program has had is the fact that the concomitant medications, concomitant antiepileptics are 384-inducers. In fact, they are all 384-inducers and we, as you know, cannot allow patients who are on drugs that are 348-inducers because it impacts the thropacokinetic profile of the therapy and it will impact the outcome of the trial. So the challenge there has been to find the right patient profile, but there are not concomitant medications like carbamazepine, oxcarbazepine, and other therapies that are 3 and 4 inducers. So we've been challenged by that. The good news is that John and his team are -- have conducted a drug-drug interaction trial that will allow us to then overcome that obstacle in Phase III. But we've really had to know the actual dose data based on those individuals that are not on those concomitant medications that would impact the pharmacokinetic profile. So what we've done is we've heightened the number of sites, the number of countries that we know well to increase the enrollment. We've seen great momentum. And so the good news is that we are planning to read out in midyear next year. And if the results are what they are, then we can proceed with a robust Phase III program.
The other thing I might add here, I know there's going to be more questions on Tavapadon [indiscernible]. And as I mentioned in my prepared comments, we're going to host an investor webcast focused on Tavapadon on December 11 at 10:00 a.m. So tune in to that, and I think if you have additional questions, that will be a good forum to get some clarity.
One moment for our next question. And our next question comes from Joseph Thome of TD Cowen. One moment for our next question. And our next question comes from Jeff Hung of Morgan Stanley
For CVL-871, can you talk about the challenges clinical sites you're facing on patient identification for dementia-related apathy. And then for the darigabat study in focalsy, what do you need to see next year to consider the proof of concept of success? Is there a particular bar for production in seizure frequency?
So the apathy program, as the 8701 program is a Phase IIa trial that's really experimental in nature. As you know, it's the leading neuropsychiatric syndrome that you see in patients with dementia. And we're conducting in all of the dementia experimentally as a first step, it's also a predictor of disease progression. There's 3 components and really decrease gold directed behavior, decrease emotional responsiveness and lack of motivation. The challenge with that is that the landscape is really still trying to understand what that patient profile looks like. Remember, these are patients that are not agitated. They're not really a problem clinically, but it does impact their quality of life. It does impact the longevity of their disease. So one of the challenges is really identifying the right patient profile. So to that end, that's one of the challenges that we've encountered, but we believe that the therapy has a great potential of being a novel therapy that will work in that population. But again, I think the landscape is trying to catch up and really clinically understand what that profile looks like. So that's been a limiting step for that program. But we're continuing to move it along. We're continuing to identify the sites that have access to the right patients, and that's really critical to get the signal detection that we need for success. So that's where we are with that program now.
And the other question was the REALIZE study. What are you looking for success with what you?
So for epilepsy, for darigabat -- so remember, it's 80% powered to detect at least a 30% placebo-adjusted difference in reduction of seizure frequency. So if we achieve it, that's terrific. As you know, we've got the Xenon product we got [indiscernible] that have had very compelling, very compelling outcomes, which fall into the mid-30s. Capra falls around 28%. So if we achieve our 30% threshold and above, that would be really a successful outcome for us. So we'll stay tuned for that. And based on that data, it will allow us to then tailor our Phase III program accordingly. But based on the mechanism of action selectivity of the GABAA-8 APAM compound, we are very hopeful that this will introduce a novel therapy that will benefit patients with [indiscernible].
Thank you one moment for our next question. Our next question comes from Graig Suvannavejh of Mizuho.
Congrats to the team for the recent capital raise and just 2 quick questions from us. For marketing, what is needed from non-clinical and clinical pharmacology studies in order to support a potential registrational package in schizophrenia and to what drove the decision to proactively raise equity capital ahead of your multiple clinical data events in 2024
Sure. Thanks for the question. Yes. So we have been looking forward to getting the package ready to submit to the NDA. So, to summarize briefly, we've done almost all the work that we need to do actually to prepare the preclinical section of the NDA already. So we have a few things that finish up, but there's nothing that's going to be on the critical path from that area at all. So I hope that addresses your question.
Yes. And then I think on the capital raise, I'll let Susan add to this as well. But I think largely, this was one thing that we have been talking to a number of investors about over the last few months and there was a significant amount of interest in doing the raise from outside investors. And so, we thought it was a good time to do that so that we could really be focused on execution in 2024. As we mentioned, is we're going to be working on 2 NDAs in parallel. And so, to be able to have the balance sheet shored up and really have a line of sight and focus on execution on those lead programs was really the primary driver behind that. I'm not sure if there's anything to add that season.
We'll continue to be judicious with our spending. I mean ultimately, what the capital raise enabled us to do, as Ron said, was focused on execution, the runway gets us into 2026, so we can turn over the data cards next year and not have any overhang limiting our upside potential.
And our next question comes from Charles Duncan of Cantor Fitzgerald.
Ron and team, congrats on the progress. Had a quick question on emraclidine and one follow-up on dorigabat.In emraclidine, the ADP study, I'm wondering if you could give us a little more color on timing of data and really the kind of rate-limiting step for enrollment of that study? And what would -- what's the key parameter that you're looking for or looking at to decide whether or not to move forward in ABP?
Yes, Charles. So as we've talked about in the past, this is more or less a first-of-its-kind type of study. And right now, we're in healthy elderly volunteers. And so, we haven't -- to that end, we haven't given any guidance on when we expect to enroll that study. I'll let Ray address how we're thinking about the indication itself. But just stay tuned on that, that's something that we will continue to move ahead, and we're looking forward to. But we're not going to provide any guidance on enrollment on that program at this time.
So to follow up with that, Charles, for ADP currently, we're doing, as Ron mentioned, multiple ascending dose trial in healthy volunteers. There's other work that needs to be done subsequent to that, that will allow us to understand the dosing in that population, which is important because there's a very different manifestation of symptomatically, but also population in terms of the psychotic symptoms that they experience, mostly hallucinations and illusion. The good news is we got fast track from the FDA, which will allow us to work closely with them in terms of what that development program looks like. So stay tuned for that.
And then Charles I think you got a follow-up on darigabat.
Yes, quickly. Just I think Ray mentioned that he's encouraged with high rollover rate, probably not a surprise in focal onset epilepsy if there is perceived efficacy. So I'm just wondering what a high rollover rate means. And more importantly, what are you seeing in terms of persistence in that open-label part of that study?
Yes. So Charles, obviously, we're always encouraged by pace rolling over into the open label extension, meaning that they are tolerating the therapy well in terms of efficacy, it's really hard to really understand that because the data is blinded. And it's in the patient's purview to roll over, they feel that there's benefit or they want to continue with the therapy. We can't comment on the open-label extension data that will be disclosed when we lock that database and that data becomes available mid-year next year. So while we review the data for data quality, we don't review it in terms of patterns of anything other than that at this juncture. So we'll stay tuned for that data readout in mid-2024.
Look forward to the progress.
Thank you. One moment for our next question -- and our next question comes from David Amsellem of Piper Sandler.
So just a couple of quick ones. Looking more broadly at emraclidine, how important is it to develop it and explore clinical work as an adjunct to D2- blockers. How do you think about that commercially? And then secondly, as you look at the Kappa -- can you talk about what you think makes sense in MDD vis-a-vis monotherapy or adjunctive therapy? And how you're thinking about it based on the body of data for your competitors and what you've seen today.
Okay. David, so in terms of objective treatment, so we are very encouraged that we do believe that emraclidine will be a best-in-class muscarinic agent with once-a-day dosing nodes for titration and a very benign tolerability profile. No doubt that adjunctive treatment plays a role in the clinical landscape and probably has utility. The first step is for us to really understand the dose range in the trials that will read out in the second half of next year. Following that, then we will pursue other programs in schizophrenia, adjunctive treatment may potentially be one of them. So we're not going to comment on that just yet because we really want to understand the profile of emraclidine and schizophrenia first before we consider it as an adjunctive treatment. In terms of core of MDD monotherapy versus adjunctive therapy, as you know, there are 2 companies that have done -- one has done a monotherapy. A second one is on adjunctive therapy. If you look at the outcomes of those trials that really are very similar, the monotherapy to what standard of care has shown and the adjunctive treatment is very similar to what the standard of care as adjunctive treatment, basically the neuroleptics have shown. So if you think about the value proposition of KORA in as adjunctive treatment to displace the neuroleptics because of a better tolerability profile based on the neuroleptic tolerability profile, it seems like a very exciting approach and also has great commercial and also potential but also in the best interest of the patients. So we think that's probably the best approach, but we're evaluating all that. We're continuing to understand our core compound internally, which we believe has the potential to be another best-in-class therapy. So we'll stay tuned for all that moving forward.
One moment for our next question. And our next question comes from Joseph Thome of TD Cowen
Great. Just a quick question on the tavapadon filing strategy. I think it was mentioned earlier that it was going to be a 2025 submission. So would early in late Parkinson's be filed together? And is there anything else aside from the open label that is kind of gating to that submission? And then maybe a second on the panic disorder study for darigabat. I know there's a minimum number of panic attacks that patients need to have. But is there a maximum number that patients could have given that the primary endpoint is panic attack freedom?
Joseph, thank you for the question. So for tavapadon, yes, we plan to file in 2025. As you know, those studies will read out next year. Nothing is gating. In fact, the open-label extension has progressed well. And those exposures have been met. So we're excited about that potential in the Parkinson's arena. In terms of the panic program, you are correct that they have to have at least 8 panic attacks in the month prior to screening and then 4 panic attacks in the 2 weeks of screening in order to qualify for the trial. So we don't have a [indiscernable] effect. We actually can show that there is potential to reduce panic attack symptoms, but there is no maximum. So it's really around meeting the -- that minimum threshold. And then from there, you can have as many panic attacks as the patient is experiencing. We're really wanting to ensure though, that we get the right patient profile that really drives success, and that's why that criteria is set that way, and there's precedent for that. So we are continuing to enroll in that program and excited about the potential derivative at really being an innovative therapy and a needed therapy in the anxiety disorder space. So we'll stay tuned for that data in the future.
And part of Joseph's question about filing for avapadon early was and/or late. Could you just give a little more detail on how you think about the filing for tavapadon.
Right. So when we filed the tavapadon NDA, we will file all 3 trials and the open-label extension. So we will get a label like others have received for the treatment of Parkinson's disease. So the NDA will consist of the TEMPO-3 trial, which will read out in the first half of next year, which is the adjunctive to levodopa trial, the 2 monotherapy trials that will read out in the second half of next year as well as TEMPO-4, which is actually the open-label extension trial.
Thank you. I'm showing no further questions at this time. I would like to turn it back to Ron Renauld for closing remarks.
So I'd like to thank everybody for joining us this morning. And keep in mind, again, just to remind folks about our Tavapadon Investor event on December 11. Thanks, and we'll talk soon.
This concludes today's conference call. Thank you for participating, and you may now disconnect.