CERE - Earnings call 3 2023 | Cerevel Therapeutics Holdings Inc

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

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.

Matthew Calistri

you. Thank everyone. morning, Good joining our you earnings quarter call. us appreciate third for XXXX We you'll Ron hearing and today's be On call, from Officer; Chief Dr. Renaud, Executive President our Dr. Ray Medical our Officer; Sanchez, Chief Dr. John Renger, Scientific our Officer; Chief and our Altschuller, Chief Susan Officer. Financial

we to candidates website. President an our activities remind now both release that this be we review press benefits product our and available Renaud, of of will regarding development XXXX performance format filed which with morning, our and achievements to the and our and our you as risks our quarter of from as third are overview will the to today, We well to, statements of timing refer I I our CEO potential updated to forward-looking During to that SEC call and trials. outlook. views uncertainties. financial and over Ron product current you the our that among of clinical would provide and please like specific hand detailing Cerevel information things, corporate the encourage our call the other making on attributes strongly presentation, reflect related

Ronald Renaud

for you and quarter results third and joining good Matt, I'm we to our third and with will today what review preparing thank expect exciting morning, XXXX. XXXX all everyone, to for be Thanks, how our business to us for be quarter pleased call. results of an we're you discuss

To as one believe forward organization the the X different the will next year planning we the thinking and and across multiple indications. of X start with for we most be in management on some this Cerevel. mid- team in a of me high-level for pivotal pipelines is one assets robust readouts how late-stage And Let thoughts look different has future industry. about to neuroscience begin, Cerevel

over XX XXXX, capital our of months year. our expected significantly runway sheet, next beyond data well the bolstered extending balance raise readouts all recent Our into

maximizing As an assets. creation organization, we opportunities for have leads and of lead our each on the value execution focus our

ongoing out Our data to laid are and for time last we well, expect we and emraclidine clinical quarter. deliver on lines tavapadon, trials the darigabat progressing

planning in X file are NDAs to for positive. XXXX exploring emraclidine opportunities are preparing tavapadon for proactively indications. we and our and data We programs success are if potentially lead life in in Furthermore, cycle other diligently

MX potential currently titration. now medicine need believe as novel selectively psychosis targets PAM, a may provide for MX, effects Emraclidine our disease next-generation overview of By we mechanism the selective that emraclidine of for the of is symptoms without targeting challenging a Alzheimer's or programs. and me side psychotic Let without antipsychotic once-daily allosteric in current our antipsychotics. reduce BMXpathway. with is an action modulator, lead Emraclidine, development positive schizophrenia

registrational potentially EMPOWER-X in X of EMPOWER-X to trials half data Our are well, XXXX. read out and the enrolling in expect and we second

We who about are to in the it the schizophrenia bring potential seen patients with decades. benefit innovation emraclidine and have of may not excited

of treatment the first agonist partial Moving in the disease. for Parkinson's to tavapadon DX/DX development

a let December announce disease excitement readout alpha-X/X/X-selective-GABAA, opportunity during focal our me Darigabat and novel both in greater first half second We in patient XX, on trial the expect is will Parkinson's this and XXXX, epilepsy the to potential mechanism And explore to a significant We motor turn to in in first investor to Building half depth. disorder. effect of will adjunctive panic pleased control our we which with our year. we profile. TEMPO-X that coming development the sustained favorable monotherapy tavapadon selective TEMPO-X we deliver data believe be on to readouts its webcast a of this currently there the address TEMPO-X with side and needs our finally, for program, are host in for

recognized we X.X the treatment United epilepsy living million that option people this States, disease. the living in and we a bring with difficult for with in month we people awareness As new can November forward epilepsy are hopeful

we're REALIZE address second focal also in discovery trial, epilepsy focused an midyear. mid-to-late on Our ADAPT additional trial Phase to to Cerevel. a come capital bring that mechanisms II neuroscience potential benefits receptor to trial readout those providing forward pipeline, on that II hope excited pipeline to including forward XXXX our programs, of here we innovative disorder. our about for I'm diseases. Behind antagonist of bringing quite opioid greater concept detail all is we that our at engine And Phase patients. further progress. And stage we our be proof to and novel doing our initiated as all look to panic is make coming has We've in the

the we into provide as possible I'll positioned Medical turn well what XXXX to in Chief added call programs. about go our Sanchez, Dr. to Officer, our are over that, Ray? We Ray now truly color neuroscience. With to some transform is lead

Ramiro Sanchez

want and Ron's the everyone. excitement sentiments about to Thank around I Ron, morning, you, good echo our pipeline.

data of I clinician, Beginning our the emraclidine enrollment. trials, Empower tell remains energized are with in risk you to data response can reinvigorate XXXX. I of that the are priority potential am recent we program mitigating efforts make utmost neuroscience Cerevel we half meaningful have diseases. our and with in Preserving the while the at by difference former pleased a a placebo for patients is to advancing quality with expected second and lives here As these

development that acute include of these expect service non-clinical trials the FDA with prioritizing We're We powered designed XX-week symptoms. the As living experiencing psychotic exacerbation other in potential plans and development for what package. a completion psychosis, the for trial registrational disease to package tremendous emraclidine will to a this maracalgenos accelerate the substantial reminder, disease criteria potentially will meet guide EMPOWER-X EMPOWER-X our trial schizophrenia. X-arm need. potential based are we volunteer our trial an areas Phase enrolling in we to further unmet ADP, extension In adequately a believe studies of ongoing, Alzheimer's are or on pharmacology and clinical important schizophrenia We and healthy adults and in underway. EMPOWER-X has of pivotal in registrational clinical plan with safety I trials open-label trials advance a is evaluate necessary our as also indication elderly and X results and

disease. Turning in DX/DX now agonist to tavapadon, partial our Parkinson's

with trials known a the are TEMPO Phase greater ongoing which open-label than rate. Our III are corresponding encouraged along we of in extension XX% rollover collectively trials by

comparable potential second coming an we our TEMPO-X potential used believe are improved prior you mechanism of forward Unlike in for profile. action side benzazepine tolerability, as to half of the darigabat's tavapadon acute We with activity TEMPOS-X in of or and side the there tolerability data for only We with look provides during effects favorable walking half PAM, the other XXXX. and scientific is angilotic for dosing. With data chronic effect benzodiazepines, episodes potential for and for first to December. the both expect event rationale its abuse XXXX, selective-GABAA for debilitating through novel to data well investor antiepileptic potential which darigabat, profile and to due in anticipated X as clinical and

high in REALIZE a realized epilepsy Phase rollover our open-label in into extension. and from are the encouraged XXXX, midyear focal rate we trial II results expect continued We by

patients numerous bring II A Phase a need. drug stage update a disorder and currently Officer, nearly treatments of reality. Cerevel's is ADAPT this our in epilepsy, over to approved not providing in to trial it most has With excited to Dr. new XX we turn the as John? panic in forward the address chronic of potential been I devastating on therapy to our the focal diligently potential make pipeline disorder Renger, has daily proud provide years, team that, that of let potential potential to early are to to Chief underway. John am late-stage is neuroscience diseases, panic our portfolio. mid some and Scientific the so Beyond about -- the darigabat an me working

John Renger

early Ray, CVL-XXX. discovery pleased development research opioid and program, and also I'd CAF made here our I'm core Thank on morning, you, in a progress or good to at the Today, focus receptor with very like everyone. Cerevel. clinical on we've antagonist

Kappa both We believe [indiscernible] of have interest disorder. trials receptors. well in of use and be occupancies be able depressive in and dose tolerated. multiple will the currently substance single believe a we'll our multiple opioid been explore which we generally receptor Further, has we ascending CVL-XXX and completed able disorder major range both and anticipate to such interrogate We indications to as

will new Kappa Our both characterize displacement the compound Phase penetration clarify preceptor across I to occupancy receptor ongoing further exposures. trial selectivity and

the we near look We impact of are updates more this encouraged providing in potential the on to our forward asset, plans and by future.

labs have we here selective of growing and within TIM-XXX PDEXD-sparing programs, and potentiator number agonist, developed a in inforce antagonist to KORA, our continue at which issue Cerevel, selective we Beyond exclusively a progress, some program. a including our

to for the our to Officer, programs We Chief I'm Susan updates Financial further will and over financial specific as our to appropriate. for it With Susan? going these performance review turn provide that, Dr. third plans Altschuller, quarter.

Susan Altschuller

John. you, Thank

cash, securities, with, balance capital ended XXXX. to along and support a existing the October, we $XXX high-quality new potential from capital, in raise, opportunistically financials. bolstered our Turning quarter with investors. million of will into with roughly strong sheet both million This our third Cerevel's we our equivalents marketable operations additional providing In and the validation $XXX cash

administrative Turning of development general $XX Operating and of to the $XXX were third expenses. million research million, approximately $XX comprised expenses of and million XXXX. expenses and of quarter

X over lead concluding will on Looking in our our call remarks. a hand value Ron forward, allocation filings focus said, prepare optionality the execution to that, assets to pipeline. I advance That strength us potential and further pipeline, we approach provides take the back will we for to build NDA as parallel. resource our to and disciplined for enables financial With our maximize of his

Ronald Renaud

with At sheet the runway Susan. provides multiple mid- past X an unparalleled different believe neuroscience and late-stage you, year next in we expected us across Cerevel, readouts and have XXXX. assets with balance that we into Thank pipeline

mission. would -- Cerevel's data our trials, day leading thank seek on tirelessly With mentioned, for high-quality we want We are as And for exciting organization. These that, on none preparing and the executing this clinical focused at trials, delivering deliver I appreciation times who of this and are employees every to of I of to potential so open to questions. our achieve my to whom aligned and all none investigators call possible. work X want participants without and Susan be also proud sincere filings. year, offer be in to I'm next what to would let's our NDA Cerevel, our

Operator

our One our Michael Jefferies. question question. for first Thank Instructions]. moment of And from first Yee you. [Operator comes

Michael Yee

everyone's know on questions. I Thanks the execution. for focused thanks question, the Ron. and for update, Two

emraclidine. second on been are specifically placebo you're arms and confidence confidence epilepsy. a are concern you well. site patients there you an changes. progressing last some of First the readouts others you that us actually because and study us help on maybe time things And some and just There's the you your understand right there know could I has on selections executing Obviously, help of what the And maybe what initiatives about a confidence timeline that describe for that things the historically bunch into Can right are question the was the enrollment? the as happening. on since integrating quarter, what concern us gives that on is team, maybe issue, might give competitor the that's about for give that that

Ronald Renaud

Yes, sure.

the first me address terms then part of and on site take let the second work emraclidine part our selection So then epilepsy of placebo question, in and from study. first Ray your the let I'll

had. the are with So doing trying progress saw last sites that ground. Ray we're enrollment I've can to by the data, that team what's spent also boots think here working quarter, of the to maintain continue the And look, we reduction of placebo we and pleased of we've And we talk stand here the about That part the as strategies. that focus to on going the on mentioned those second Ray issues we with at the some the far. said, how question. our But think that challenges with quite see that address progress development and make the I the address and think leader as continue with ensuring epilepsy guidance time that We're of group we the about look, focused to we've really on. why that's and I'll our with think seen the site clinical we how And sites so to groups in we're and our and the clinops in let to variability things about maintain all I our and always the going on of we we studies. placebo selection will all quarter. given site quality gets remain and focus rigorous -- on

Ramiro Sanchez

you, Thank Michael.

defined you historically having that part, as like. It's look trial. the access for right know, I've patients what raters. does to good Michael, And So good most determines solid the really the a and the success the side of really

So slowed that's our to in at the that any emraclidine learned enrollment is where as to when we're achieving in manage try year. quite data landscape the Ron quality have bit if the increased robustly But you diluting momentum And to to mentioned, been more trials, without, seeing a and competitive started then are continuing they how of momentum first and effectively. the look end, the for we in way. spring the year we started we've this What down achieve.

success So forward. the sites that we fleet again, the communication frequently and communication very close of greatest moving have having ensuring us the recertifications that with ensures continuing that radar occur

epilepsy, these of profile response selection, trial that and epilepsy approach But to placebo response responses, oceans included and dedicated at patient as really are seeing same that you ensure in placebo and aggressive the blinded but and know, and taking In in quality cerebellar also mitigating spinal many. sure indications our the terms data protocols about it's also, each the are monitoring -- mitigation in placebo surprise we site, the trials the epilepsy is we right is data like that placebo to in approach having there. would by the the patient making ataxia

same So placebo to we're will the for all reduce to epilepsy trials success. reduce we've taken to all the our really likelihood we're greatest to approach placebo response, taken together, taking response there is help these confident be that trials we're of positioning and approach

Operator

Thank moment Paul you. And our question from Matteis for next our comes question. One Stifel. next of

Paul Matteis

really guess you and on they tracking data are of ask changing look guess, and the studies to? ask results, site I that recent a wanted obvious, blinded what and related like getting setback program, in a or you that. this beyond confidence emraclidine, Kappa sort to of the the when I quick basis honestly similar emraclidine response within you're that question huge and to for saw on that specifically quality you that those you patient implications the that John. And the I question the at intended wanted just is and anything TAAR-X else pans I metrics a today give to hope then on placebo

pursuing. the your site [indiscernible] Mu really on efficacy Mu. high selectivity plan Kappa that contribute actually might thesis Just both per behind some What's to and of in over that the you conditions

Ronald Renaud

I'll Yes. Ray me first let the take part.

Ramiro Sanchez

Paul, So question. good

it more blinded. monthly is the a sometimes So basis but frequently, we data and review on

we they're really, we're correct quality, of assessing all are not the to that that and parameters ensure So in data that terms want conflicting. of

occurs, so, they with doing that make the if level site a and need to frequently they need the validation, we do raters sure to course, or that at intervene And are have to the refresher what that of raters. occurs obviously

to the do patient really needs the to meet criteria have occur the to at earlier, that profile mentioned mitigating terms of that for patients do qualifications that we we're it's right looking around having trials. that an the the enrolled really independent of other in how in terms that? I measures We that In looks them in be question, that placebo confidence ensure committee response, and they for Michael's at the

to actually a then success that at to -- protocol of So the way allows increase each site we site every each placebo us that and standardize at have and we approach response. placebo patient mitigate likelihood the

and understand have So so placebo as really, years advisers the who response from into from as the taken learnings our we've programs. many them key well infused advice

So which the of a limiting all measures mitigated. we're countries, number to placebo We're all to the response sites, contribute number limiting that ensure response. confident is taking placebo we're of of that, also that

If those mentioned, you trials. trials recent over XX that you've trial X over that the in look the countries, at sites

of that ensure minimize the greatest to that And likelihood trying contributes variability, all to of success. so, to everything we're

Ronald Renaud

antagonist. Paul, Sorry, Kappa for Receptor thanks on and Oploid the question

question what So of to indications. provide your about does in Mu terms potential in benefit therapeutic

And so, would patients. to as example, opioid an do what I syndrome is withdrawal point

our but selectivity receptor can [indiscernible]. have what about we achieve if go to through at range Kappa, profile. to want so to Kappa tour potentially do, What continue the receptor exposure can in you and we bring you if occupancy curves, go up can curve a And where with do we think occupancy is you we can we

that And what reduce you that a because what so, preclinical data cause from potential that why to are undergoing you you're can therapeutic does the Mu what that also actually statement exposure the achieve we think or use of models industry about for they that remove and reducing like to see us there exciting the the long some agonists. would the from in patients withdrawal potential things the opioids, where term, is can you but of trying it's seems get things if something benefit in is in is that is, undergoing abstains Q relapse provide and to Kappa you believe

What the symptoms. dose you you antagonism approach the induce opioid block the withdrawal as without an potential. there the if to of the patient it lower antagonism actually is for if Kappa Mu can that kind patient. to bring with the does range about an in being any has dose might that the actually future begin think that opioid you population, can then increase ability activation, exposure so, that the having could Mu how in progresses, And actually you that you And benefit a of is

let's also opioid you opioid, the an you that actually take population, the with could opioid, for in both point. blocking antagonist but so Having what they say can potentially, a benefit. So at present rewarding could agonist activation exposure they as can you harm they prevent relapse, have what an that to terms on a potential get depending safety patient of an benefit measure

And Kappa going time of an protection over range that so, is would start the you starting patient with benefit And patient. on dose dose up selectivity can range. so antagonism you where build phase a Mu there the of a you the imagine that that withdrawal, if could same you through more have do exposure, what of in having board is

So we're that's how about it. thinking

Paul Matteis

lot. a Thanks

Operator

moment question. next Penal question Wells our One our you. Thank for And from next Fargo. Muhi comes of

Mohit Bansal

thank a quarter. is questions. that Really dopamine on used not are outn financing. X for comment I the our agonists as they have fashion , an tavapadon. on little And In uneventful much. doctors having you are are of One checks, bit and suggesting appreciate the

So how what you clinically, can darigabat -- how just mitigating could was and you you talk that? about not one, for thinking a me about benefit, be? for little starting it remind the reason success enrollment the second then And you're bit should about bar slow darigabat, what are

Ramiro Sanchez

Tavapadon. that Mohit, So for question thanks on

at agonist the of to show and monotherapy that. and trials benefit the DX/DX that Parkinson's X both that's receptors the symptoms, that be symptomatically the If from disease. daily functioning which tavapadon import primary at the looking about on that agostriatal transformative X, adjunctive looks a being going it's novel and the a we've therapy endpoint baseline Part you the change therapy us to targets an motor at designed the and confidence and primary subpectively looks monotherapy, the partial as in that's direct program gives UPDRS, of the Clinically, treating those really think Part pathway mechanism a the is XX

benefits impacted really only symptoms. motor So to the the on show symptoms, motor of life is but not quality by

primary on-time we're first what's adjunctive treatment but is half increase troublesome without trial, at end in best to trade the adjunctive decrease the of the is first as the the next importantly, For point which the and dyskinesias, with looking clinically really year, which readout benefit tavapadon the of levodopa relevant. our off-time,

thinking is on thinking the diagnosed So the of meaning program. are treatment. as that's that therapy levodopa patients fact-bone as adjunctive really, how introduced we therapy, needs best patient then and we're first to that initiate when as best to about And when being really the be it

patients results we're we year a as next of the read for therapy they expect treatment Parkinson's. to that NDA hoping if that out then that file give proceed that will we So symptomatic will transformative and

Ronald Renaud

can Mohit, question? that repeat you

Mohit Bansal

you that was do in you are mean the mean Yes. the enrollment I slow off reason what right? fact to with more issue the can there? I background medication, beginning? were it was I so trying the taking was, remind question mitigate to moving And that? what's for the think how patients the you

Ronald Renaud

No.

a are drug reasons enrollment more antiepileptics, X -- X and they resistant. who are a epilepsy at dose. patients there no continue program. So of with the for these issues Remember, couple than static least on the those are at therapies are

changed. that's not those So

that challenges medications, concomitant that the had concomitant XXX-inducers. has fact is are antiepileptics of the One the program

are it we, trial. you therapy In know, XXX-inducers it allow the impacts are of they thropacokinetic because as are impact and patients that will outcome on the the fact, profile the drugs and of cannot XXX-inducers all who

therapies are patient challenge like the and X right the find but carbamazepine, X been oxcarbazepine, and there concomitant So medications to other profile, are inducers. has not there that

impact good trial So us pharmacokinetic III. that obstacle Phase overcome that. we've the conducted we've dose on will have interaction that -- in know then is those data drug-drug and had to the concomitant are by based John medications that are really news to a on been profile. actual not individuals challenged that The would team his those allow But that

done increase We've the sites, know we've seen what of we've we that the the to number of countries momentum. great number enrollment. heightened is So well

robust they program. next are, we news proceed planning read out in good we a year. III are is that midyear And with results if the then are so can Phase And what to the

Ramiro Sanchez

to on might here, XX:XX going I we're And on XX my more mentioned December on prepared I Tavapadon focused host questions comments, going add [indiscernible]. a.m. know as I Tavapadon thing investor there's in to an be webcast other The at

that, think tune to and have be good a some if questions, I that get in to you additional will So forum clarity.

Operator

our And question question. comes our question. Thome from for our Hung next next next moment Morgan for Joseph our question Stanley One next comes TD One And of Jeff Cowen. of from moment

Lee Hung

For on you the challenges CVL-XXX, you're dementia-related a study concept particular And can for frequency? talk then need clinical do bar next of about sites seizure the facing patient in you there what to see identification the focalsy, production for apathy. darigabat Is consider success? proof year for in of to

Ramiro Sanchez

program, the as in is So apathy program really Phase experimental nature. that's the trial XXXX a IIa

like. these trying is it It still that is in it's As landscape patients see leading progression. the the and impact quality directed what predictor And dementia lack the a disease. emotional that really profile their patients not it's dementia. you but They're that Remember, to syndrome agitated. also we're does first a conducting really impact really all motivation. responsiveness that a longevity of disease step, not their decrease you does of problem neuropsychiatric clinically, looks understand of with as There's challenge with in X are of and experimentally components know, patient the The of that life. gold decrease are behavior,

is profile. challenges the So right patient the one identifying of really

a looks has think of catch understand So a I that work that in the But the landscape population. of end, again, that like. that novel challenges that therapy one great but being we've and the potential that is what profile will up clinically really to we therapy to trying that's encountered, believe

along. the that's identify really that sites So been and continuing that's we're limiting step to have for it to access success. patients, that to detection to signal critical the for continuing program. a the need move that We're get right But we

with program where now. So we that's are that

Lee Hung

And the success are the with REALIZE you? study. looking What you what question was other for

Ramiro Sanchez

it's for reduction for to frequency. XX% So placebo-adjusted remember, difference XX% a epilepsy, powered of so darigabat detect least at -- seizure in

achieve that's terrific. we if it, So

around we compelling, that outcomes, got fall Capra got [indiscernible] compelling we've the which the product have know, you very falls As into had Xenon mid-XXs. very XX%.

our achieve that successful So XX% us. if we above, for be a outcome would really and threshold

allow for that. stay to on will the we'll accordingly. will therapy Phase III are benefit very program patients introduce then So on a novel of compound, will it selectivity the we based of tuned hopeful with data, us action And that tailor that GABAA-X [indiscernible]. But that our mechanism based APAM this

Operator

for one you moment next question. our Thank

Graig next comes Mizuho. Our question from of Suvannavejh

Graig Suvannavejh

team recent Congrats raise from X the for to and the capital us. just quick questions

For marketing, package to in decision and the of order pharmacology a clinical potential what and from capital raise is your equity clinical proactively events XXXX needed what to non-clinical ahead schizophrenia studies to drove in registrational support multiple data in

Ronald Renaud

Thanks the for question. Sure. Yes.

submit So forward been looking NDA. getting to to the have we package the ready to

NDA the do summarize almost already. all work to need the So, that prepare we've briefly, we done of to actually to the section preclinical

that's nothing area be few So from all. the finish going to up, critical that on there's path we at things that have but a

question. So I your hope addresses that

Ramiro Sanchez

on this few months have this over was last significant the investors capital I from Susan of was I there the a one think Yes. add investors. of to talking a in And we to outside then number think as about largely, well. the interest I'll But that let raise, raise amount and thing doing been

good so, to And XXXX. it that time execution could focused we thought that in was a really be do so on we

As parallel. X going we're NDAs be on in to working we mentioned, is

the to anything able sure that. really driver sheet if those the be line have there's lead of shored execution not primary programs I'm to a and add was behind so, have really balance focus that sight season. to on and on And up

Susan Altschuller

us enabled the we be to data as and runway cards the into us focused next to have Ron continue not judicious capital over any We'll turn our limiting was with overhang do, gets our can the spending. potential. ultimately, mean what said, on execution, upside XXXX, I so year raise

Operator

Charles of from And Fitzgerald. next Cantor Duncan question our comes

Charles Duncan

would not a Ron a and question the give what ADP you move decide on little kind for color team, dorigabat.In of in data and or what's quick if more study? ABP? progress. congrats you're us timing on follow-up for really whether one to at Had step on And emraclidine -- or of could parameter the enrollment and that looking forward rate-limiting wondering the on I'm emraclidine, to that the looking key of study,

Ronald Renaud

Charles. Yes,

we've as talked of So healthy right a volunteers. about in study. is we're past, And type the less elderly more this first-of-its-kind in now, or

going we that I'll when any Ray and expect But provide we're end, indication will on the we haven't something tuned we enroll how that looking we stay that any -- time. haven't itself. on guidance continue about this move ahead, to to forward to guidance on just at address study. enrollment so, we're we're to thinking given that program And that, But not on that's to. let

Ramiro Sanchez

from looks also to news very So Charles, up population, ascending symptoms ADP to fast be with that what in as which hallucinations to the experience, terms that, terms done different that, trial work got symptomatically, to will important illusion. other because that allow which but The that work and multiple understand dose us to manifestation with healthy in track allow that There's of of like. population closely will us the we're subsequent doing, needs Ron dosing is good a in program mostly there's volunteers. that we currently, for follow mentioned, development in FDA, of the is psychotic they them

tuned stay So for that.

Ronald Renaud

darigabat. then I on you think Charles And follow-up a got

Charles Duncan

Yes, quickly.

onset Just is efficacy. I in encouraged rollover high focal probably not a surprise there think he's if with Ray mentioned epilepsy perceived rate, that

rollover that high wondering in importantly, persistence of part study? means. are in just more you terms what of rate a And open-label that what I'm seeing So

Ramiro Sanchez

Yes.

the is pace they roll therapy. the well So with open-label efficacy, into to blinded. they there's label that understand or mid-year rolling to to Charles, it's of when they available can't that extension, hard the purview that on extension obviously, continue we patient's over, and we're data in really the benefit because the that by are therapy that over in want feel becomes next database data tolerating meaning And We be that the it's year. comment will data terms really always encouraged open lock disclosed

of So while of terms in data we this for anything we it other review the don't than at quality, review patterns juncture. that data

mid-XXXX. data in that for tuned stay we'll readout So

Charles Duncan

forward Look progress. to the

Operator

our question question of from Sandler. for our -- next moment One Thank comes and David you. Amsellem Piper next

David Amsellem

of So ones. just couple quick a

think Kappa and is to thinking competitors blockers. talk at monotherapy important do Looking what you on you more you or therapy? and about And And about data you're adjunctive secondly, how work as think what commercially? -- in vis-a-vis the your that explore emraclidine, how today. then broadly seen How based look makes develop for MDD you adjunct an sense it it clinical to at body as of can it you've the DX- about

Ramiro Sanchez

dosing that treatment, Okay. believe that utility. has we emraclidine a a so clinical muscarinic with probably profile. and very best-in-class doubt for plays of agent do a treatment in are so David, role adjunctive encouraged be tolerability nodes terms No very in that will we landscape once-a-day objective benign and titration the

to range us for that is the next in really in step year. first The dose out half of understand will read the the trials second

then we programs one other that, of potentially them. will pursue Following adjunctive may schizophrenia, be in treatment

to and want really yet schizophrenia just before that on comment we first we to going as not because emraclidine treatment. profile it understand of an the adjunctive consider we're So

you there of monotherapy. adjunctive one In terms know, done have that on as therapy. X companies of adjunctive therapy, done -- are has is monotherapy a second MDD core one A versus

those outcomes and the care what adjunctive of of similar, trials of have to at very care that basically is neuroleptics similar has look as very the you standard really to what treatment, adjunctive the monotherapy standard the shown. the are shown If treatment

because the the a commercial patients. best neuroleptics very of in has and a treatment interest neuroleptic value as tolerability So exciting tolerability great like seems proposition if the it the also of profile potential but of approach profile, also to you KORA based adjunctive the and also better think in about displace on

to that's another think but we're the probably best-in-class We're approach, all that. continuing evaluating internally, our we we best compound believe to be understand has the potential So core therapy. which

tuned we'll for So that all forward. moving stay

Operator

next for our of question. next Joseph from moment One our comes Thome question TD Cowen And

Joseph Thome

Great.

question tavapadon quick the a Just on strategy. filing

submission. I earlier was a XXXX it that to think it was going be mentioned

freedom? that have late patients that filed the on maybe a gating there panic there could open of that Parkinson's number for from I And submission? together? in the have. need number second of the maximum attacks kind aside patients is a study panic there's attack primary early anything then that panic be is given label But know is endpoint to disorder And minimum darigabat. to would that So is else a

Ramiro Sanchez

for you question. Joseph, thank the

So we in for yes, file tavapadon, to XXXX. plan

you year. As out next read will know, gating. studies those is Nothing

progressed those open-label the And has met. fact, well. In extension exposures have been

So we're in about that potential excited the Parkinson's arena.

panic the In and qualify the prior screening X then have that to you least to X screening attacks at trial. have attacks in weeks order month correct are to the terms of the X of for program, panic in in they panic

show So have [indiscernable] but actually panic we is We to no there is reduce there a don't symptoms, attack maximum. potential that can effect.

patient meeting there, it's really as experiencing. to drives then for right why -- attacks criteria way, So that we set really really as that around patient there's and from you that threshold. and have that that. precedent many is wanting can that And We're though, get profile is the that's panic success, the ensure the minimum

are potential really at and therapy innovative about anxiety being the to and space. in continuing we a program So enroll an the excited disorder in needed that derivative therapy

tuned we'll future. in for data stay the So that

Ronald Renaud

of filing tavapadon. avapadon how give the filing Joseph's a was Could you more part And for just for about think detail and/or about little on you question late. early

Ramiro Sanchez

Right.

and NDA, So open-label the when all tavapadon the trials we filed we extension. will file X

like So the of label we received have get a for disease. treatment will others Parkinson's

is next extension out monotherapy in read open-label adjunctive consist X half year, well So as TEMPO-X, actually will trial, in trial, next out first which is second the of the which the half which the of that NDA as trials levodopa trial. the TEMPO-X year to the will the will read of

Operator

Ron further remarks. to showing to at I'm back Renauld for questions you. it would time. no Thank I this turn closing like

Ronald Renaud

everybody remind us So folks talk keep for to mind, we'll I'd in like again, December morning. to and on thank soon. just Tavapadon this And Thanks, XX. event Investor joining our about

Operator

concludes you you today's and Thank now participating, conference disconnect. may for call. This

Cerevel Therapeutics (CERE) 1 Nov 232023 Q3 Earnings call transcript