CERE - Earnings call transcript Q1 2022 | Cerevel Therapeutics Holdings Inc

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Operator

Good morning and welcome to the Cerevel Therapeutics first-quarter 2022 financial results conference call. At this time, all participants are in a 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. of and President Relations. Vice Calistri, Corporate Investor Strategy Matt Please go ahead.

Matt Calistri

will be Ceesay, morning, Good Mark call. Chief you you'll Dr. Tony Ray everyone. Officer; Executive joining and Chief John and you. our our On Q&A. from Officer; join Chairperson Coles, Financial us call, Sanchez, earnings appreciate Officer; Officer; us XXXX Renger, Interim We Thank for our Bodenrader, Chief Scientific Dr. President, our first-quarter for today's A. Medical our hearing Dr. our Chief

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

Tony Coles

approach for develop we're alpha-X/X/X ahead. in innovation trials Phase emraclidine, R&D passion we by XXXX, deep We're for Phase primarily Xb emraclidine people and innovative the our what's to possible capital neuroscience. everyone. for announced made Thank or and team neuroscience. And and the and and to quarter, then seek to the just PAM. results the subtype And adequately We the GABAA diverse transform at date. company, unmet of we These diseases unique experienced results and their morning, MX-selective midyear forging PAM, selective need. spoke progress wired. unmet We schizophrenia need for pharmacology premier of of take to is of with on neuroscience medical pipeline addressing selectivity parallel a need good business clear. neuroscience last affect on know the data become deep of than had you large, which not our focus X with solutions call. allosteric some the how knowledge utilize of we only powered in I speak year drug through deliver the our pipeline, growing novel therapies got modulator but our difficult-to-treat talented brain all of vexing a the less to really in begin two and Matt, positive approach. receptor announced and our very our most people we for with to continue to we to darigabat, finally, our neurocircuitry a we're we execute initiate and in XXXX proud we've I'm is living society broad track candidates. benefits the We've patients When or on us schizophrenia our families ago, aspires and Thanks, positive to to anxiety you diseases. positive joining in a that on data Cerevel that first-quarter neuroscience In understanding differentiated We

tavapadon in data XXXX. we anticipate pipeline, to late-stage Phase trial data our half have In the expect five at Parkinson's. specifically readouts next year, Looking our of first in we from X

needed announced trial second And in Phase early-stage this what in CVL-XXX morning. in Phase expect registrational Parkinson's, we data from expect as XXXX, XXXX, half darigabat ongoing would our drug. dementia-related which from data apathy. trials proof-of-concept from we our midyear is for expect also Xa X X tavapadon the We complete expect we trial focal In epilepsy in we of two the for our Phase package data that

of follow financial to Phase of recently the operations with data in into results expect with announced this to we're milestones also We important from two and well in is schizophrenia XXXX. XXXX. support set of emraclidine, trials a our in half first capitalized data X strong Cerevel position,

sharing in and an risk in programs $XX.X the exciting into upon in additional million of on XXXX. Chief Sanchez, milestones to the I'm turn of of many Officer, really funding which Dr. the growth, and payment forward future. marketable you entered lead and to quarter, to we looking Ray our in our some over updating As our period detail now Ray? second tavapadon Medical had readout call Cerevel of the equivalents provide million about timings. securities we we annual the close first April cash, embarking added arrangement $XXX cash the from is I'll to anticipated

Ray Sanchez

Thank morning you, to you. of Tony, all good and

As positioned neuroscience. outlined, well is has in Tony pave paths new Cerevel to

the diseases address tolerability options pipeline and profiles. Our forward our neuroscience enhanced to of most with some challenging treatment brings seeks new

drives all former a a personal, professional, life. each attest areas family with The better of treatment to the people can clinician, for challenges treating what schizophrenia, disease is day. that I rippling us effects and the options has As of need in patient's

or with in our rapidly into results, we MX turn the results impressive. ago, first robust weight significant antipsychotic those very development. truly positive and doses are positive We're extrapyramidal clinically differences effects Both by encouraged we now emraclidine in no data moving compared and with of Xb emraclidine, our were meaningful announced allosteric to meaningful modulator. Less of next than phase schizophrenia, year effects, placebo. statistically gastrointestinal and demonstrated side Phase gain Let's a symptoms

clinical therapeutic minimizing XX, X range trials parallel, on Importantly, the two what reducing number in Running Phase we as by response. registrational observed of explore to dose well potentially designed us FDA on placebo are emraclidine, the based powered pivotal, we enables meet with to as necessary fully you trials, while in in slide midyear. variability criteria to these trials the expect We track these package. the can on the adequately service will see arms evaluate trials of initiate to two as treatment parallel of the hope

evaluate in also Beyond to and other plan this populations, indications associated schizophrenia, mechanism we including dementia. psychosis with

sites. our XXXX we as Turning medications differentiated updated use well excluded now contribute acute in very mentioned, disorder. tolerability outcome us we the on than midyear X we to to X of Phase for in expect disorders this Ukrainian treatment various readout have our concerns our darigabat, healthy second panic in as population, focal This expect were was while volunteer we Phase the Tony trial. proof-of-concept half the enrollment, we share able anticipated this to enrollment for enables provide Ukraine anxiety. sites will epilepsy, our augment encouraging data, daily now X Poland on likely in of Based indication for longer target we're broke to slower maintenance additional midyear data exploring In XXXX. results in the REALIZE, new expect the benzodiazepines. took be minimizing order added Serbia, In out than of time it as countries the one trial of concomitant anticipate no strong the year. do three new but rather the with trial in the timeline based months, in contrast in is at participate disruptions which a first These the trial coming enrollment anxiety-related trial, potential which two from Consequently, of Last clinical activate darigabat COVID-XX these in countries, the countries Ukraine. Phase and to in quarter, the topline to in to unfortunately, and evidence data opportunities robustness war remaining these darigabat's we've as to positive darigabat to sites, to to initiate

Turning partial our Parkinson's agonist, control. for motor we treatment -- DX/DX to are developing that disease levodopa a and symptomatic we're for next both tavapadon, adjunctive monotherapy as to

remain as expected track continued trials, all trials Phase on We dose our collectively with our in known TEMPO timelines. to and of the all X

data in to and TEMPOs adjunctive XXXX. of from to in the late-stage of Parkinson's first out the half trial read expect trials half out in We X Parkinson's, XXXX, in from data second TEMPO-X, X early-stage the read and

we FDA, agonist, as received Fast Turning currently our we interactions enables the data partial designation we apathy, last half dementia-related potential as the and evaluating in indication, second NDA trial exploratory for to well of year, review. CVL-XXX DX/DX are expect submission June early the this rolling more first in and which which X priority of in CVL-XXX, with In a in Track Phase frequent for XXXX.

therapies. this in will Renger, in agency path there to Officer, currently conferences. indications a are closely that, speak best Scientific We and treatment our at needed novel Chief developing are the forward portfolio forward Dr. interacting With and John looking no approved John? our about determining presentations medical since for early-stage the much with our

John Renger

Good everyone. programs. earlier-stage preclinical you, provide and Thank clinical morning, overview of like to I'd Ray. first an our

will indication to part utility an of provide We therapeutic of of have demonstrated asset of additional optionality full as we creating believe program our an psychosis. clinical and for mechanism in action novel active molecule potential First, MX-selective has the we an identify goal treating consider as this industry-leading agonist franchise. this MX

and to depressive data progress kappa our that kappa and studies. target dose major preclinical planned substance in like the We multiple-ascending this of which disorder both based compounds Second, X opioid I and the upon our mechanism program, to action disorder Phase with address highlight to single- potential would has opioid generated use receptor. antagonist clinical continues believe receptor

and has has studies. drug activity prior antagonist progressing also early respiratory the treatment inflammatory dermatologic proven action also -- and seen mechanism are of diseases We of indications. action in both depressive in symptoms proof-of-concept has that demonstrated clinical a This approvals previous program, in a PDEXB of clinically mechanism been

in inhibitor Our GI active limitations creating that major clinical is while utility. PDEX CNS the were active in CNS for tolerability to PDEXB CNS potential selective depressive limit a program and and associated use neurodegenerative within aiming avoid directed their inhibitors indications disorder of therapeutic with distress non-selective Cerevel inflammatory at prior

This made the multiple-dose, DX/DX the decision dopamine in results subtype selective of on study. use receptor further based a disorder. the our to Finally, we for was decision EEG DX-preferring discontinue investment of non-clinical treatment substance CVL-XXX, antagonist

Cambridge in robust stage labs and our Crossing our discovery pre-IND at with build to continue research programs. discovery We ongoing additional engine drug

of these progress are address to earlier-stage to of neurocircuitry unmet major we efforts come, to We understanding you differentiated and research small and to our innovation look forward believe appropriate. We updated engine needs. the on our fuel years therapeutic explore future on leveraging patient develop potential chemistry for world-class keeping disease-based molecules as our and will

to journey team's company. becoming the proud which emphasize is want of how medical important at of am I I meetings, to also Finally, our our neuroscience an premier recent aspect presence

Our publicly financial relying on now us. teams unmet I performance would to underscore and to Financial Research the team associated our darigabat patient neuroscience Congress. our Bodenrader, American the Cerevel's Interim well it their has to progress on clinical data Subsequently, tavapadon presented across commitment the of Schizophrenia turn Academy patients Mark quarter. need. the we first review company Society to I extend significant our Officer, would diseases leader our as our for our our These International to and presentations also my Neurology presented are development and highlighting also the like at ongoing over at that congratulations positioned several for with to scientific belief Chief we like Mark? are programs. emraclidine who

Mark Bodenrader

Thank financial morning's and of position the Please Cerevel's to full you, in financial details pleased our morning, John, I'm overview results. release first-quarter good strong refer this XXXX our press for update. of an provide financial to everyone.

expenses operating approximately million R&D includes which million, $XX were total G&A quarter, first the $XX and million. expense $XX of of For expense

increased discovery expenses operating of costs clinical for we the increase quarters the of efforts; in quarter our and our total the pipeline. infrastructure costs by continued by quarter approximately advancement expand to last first for Cerevel's over due as in emraclidine advancement advance an the and to progression grew support first investment increased to clinical increase personnel preclinical and expected, As This year, and driven other R&D to Relative darigabat; of prior the and personnel programs trials capabilities our $XX our tavapadon, pipeline. primarily continued was million. expenses

approximately schizophrenia the to $X.X We G&A X expect first year. two quarter we R&D last as by expense our the to continue in Phase increase emraclidine expense for trials initiate quarterly plan midyear. for over clinical by to million increased

commercial We G&A the as expect planning expense and increase the to also of activities. our growth initiation our continue of support company, we to the of R&D including programs progression the

equivalents cash received does mentioned well-capitalized. XXXX, $XX.X our of million the arrangement In that in marketable XX, Tony This our include under and sharing April As million. position March and we closing, cash securities tavapadon remain cash risk additional earlier. totaled $XXX not

strengthening our the balance We and further to in We couple continue and our call the into current cash closing multiple expect back for sheet over pipeline while creatively our readouts to about XXXX. to operations data our fund Tony we I'll resources look of value-creating hand to that, next forward pursuing years, earlier-stage discovery remarks. With drug programs clinical opportunistically extensive support initiatives. to think

Tony Coles

Mark. Thanks,

us are As delivering you see, our neuroscience frontier I great is my the we can of thank possible. particular, become let the the next the privilege and pipeline operator, will want the in this to open participants to Thank can now clinical and medicine, for in important patients and our solutions development of teams trial hope to we commitment you questions. premier who of advance daily forefront to gratitude great company. this and who these for continue and me call work, what therapies. extend to contribute our aim the broad that, new the to morning. is With we it at make with diverse in need. and Cerevel dedication And building the joining appreciation whose deepest investigators

Operator

Kasimov, Cory JPMorgan. Instructions] [Operator

Cory Kasimov

for emraclidine. two on one I've darigabat you: got and on one

XX Do data weeks X and much So patients extension those and and And may -- to you seems then that in emraclidine, in pivotal weeks. being if on in to of confidence in Phase studies the that comment the need future course, you studies for a enroll pending be efficacy can epilepsy sense the hoping enable then duration, and possibly much Serbia, XX event the efficacy you open-label having many and generating safety step? study do the as safety hoping regions? darigabat or with high-quality have clearly to how duration in for to the filing enroll trial, data your for how rate-limiting Poland you're how you're

Tony Coles

think I'll you here and data enrollment of and I darigabat, us from with numbers, the question ask Poland the Ray, first about Cory's actually started quality Serbia. to get

Ray Sanchez

looking tell they that and is But the actually -- determining are at patients six we Poland generally We're is activated those provided quality in that very can enroll. So what they sites we've good still I have countries in five number the of Serbia. because can you that chosen sites historically reason two were data.

in same hoping enrolling they and And forward. patients data start the so that we're that the we the the the number But they will be true moving next with still on working in of they'll that sites into in of are enroll, trial. the that, terms patients generate weeks few will

Tony Coles

emraclidine duration. about And weeks Ray, the the second XX was question and

safety So support the patient have package? studies can adequate Phase for we review we Cory's that let's data just question just X maybe was we the two -- -- for But just I think general emraclidine. would design would

Ray Sanchez

soon Cory need But -- know, and you're minimum exposed long-term would six with as six-week and are very ICH you that for one we of in XXX months at at pivotal safety starting two correctly, acute schizophrenia. also XXX need we per as registration, patients guideline, trials So data; conducting year. a we outlining

really addition in course, Phase is be the for exceed, registration. of that characterize trials what that we is X it range to hope needed would Our positive two those numbers. can But dose the that

Operator

Michael Yee, Jefferies.

Michael Yee

various think into to studies, emraclidine, I to know monitoring which light there that example, the blood context. is has for put ongoing? you study, study about respect how some can With on been questions the shed pressure I registration-enabling

Thank you expectations that the that wondering what is for you talk arm doesn't study Maybe about show, bit really that of expect and a that is study. and would relevance have to to So arm, rightsize could details placebo your as it study, little such placebo if just even important there was I matter? a a or you. an

Tony Coles

will to a trial offer let by registration but pharmacology for purposes. of few I'm context. require me ask standard is the going a Ray couple points agency make to clinical that comments, specific This a

working else, the certainly forward. looking additional So practice We to as The we is with But, well. Mike, are purpose, know increases primary in transient a the to set offer assurance we'll significant be they'll remind the is assess see to for going you for registration of could I else sustained everything the quite the outlined pressure. have those what And blood going everyone effect We're a pressure study, were And that if comments. Phase not some maybe effect for. these increases on And just of agencies for that. won't and in add? give did you but this Ray, is, of blood to Xb specific trial agency you sustained. comply supportive particular wanted to working we what context ordinary for have data this are ready course the would trial. Ray, course,

Ray Sanchez

that you that Michael, it, that change you this the and at give dose on in some trial of answered XXX of of as high think out sustained, XX% milligrams objective to And well. an a also, relevance, doses with But it's effect dose, X-millimeter systolic eight-week XX looking over eight just XX blood powered rule patients the Tony to from of the milligrams are mentioned, participating weeks. I and baseline. is mercury the assessing or pressure above has low

that guidance labeling, fourth Tony year. and to registration going think is required is do this read very results a X well. FDA as So in most I we're expect out trials We other Phase importantly. importantly, encouraged trial the for that this quarter Phase is mentioned, But as the the enrollment X for like of

at disclose time results will they're when those appropriate the available. we So

Michael Yee

something. me let emphasize But

Even and not, been a or alluded totally clinician if signal correct? that for point there you small more patients your or thing. labeling Is may think to it's of not be a before. that may was I relevant has

Ray Sanchez

correct. That's

So interaction as we're studies, practitioners to like effect there on this gating for is that labeling to soon. our pursue if drug-drug larger a food know, like And the is not study starting will this blood you is understand able pressure being trial inform the effect really that a any. trials to that studies, is again, sustained

Operator

Paul Matteis, Stifel.

Paul Matteis

data that On think been monitoring. I study whereas feel has study, much is I pressure hasn't Cmax, detail close talked one the that monitoring blood been important doing the about presented ambulatory to like is so of some that far you XX-hour

So the can you blood would that at pressure hours, more modest? more I be numbers for that, data I they context, interesting. just looking put more from target, totality that in into the could guess how I much think, you that put And are all have they any over on looked average depressive study we're wondering the there's been far? seen we've know studies. if so changes recent J&J. versus we the then how was One modest funded point right, disorder. publicly of a opioid couple a right was And kappa XX I am one I to on you viewed so are assuming data far major data of

in forward. would in curious Just Thank confidence you contextualize how moving your that you.

Tony Coles

start with be the that, if Cmax opportunity particularly that doing. the is Ray, continue JR, KORA with on later-stage Xb point, the you'd from appreciate excited we're and feature think pressure great. KORA about observations provide raising. the want blood would about question, point, stuff to and trial, on And later then pipeline, we're along do the I that all Paul the because the if have I we Phase JR early-stage we'll Paul, would into you think the question I then

toss to Ray, you'd So, and then it start JR. if

Ray Sanchez

which similar during if blood see and no diastolic so Xb and that that placebo agency is most really is rightly systolic the trial, recall So transient such so pressure, the with six-week the heart -- the but average on around that concerns in long-term what sustained interested trial at that blood have placebo very you rates the versus really all you raised changes really that the really much six And impact. there. effects weeks cardiovascular Cmax, Phase systolic, the pressure were to

So XX-hour you to correctly, consequently, the blood at a the certain of over trial monitoring is look pressure times. at eight mentioned weeks designed, as

We'll we'll systolic is at week it do being objective primary again, eight do weeks weeks, blood at But the we the weeks core by change eight. effects. encouraged said baseline. So minimal sustained saw as and eight weeks. the endpoint. at because from I at four We're The before, pressure it is six that baseline

around around at moment. average we effect given any Paul, versus so answer question? sustained it's your really what And Cmax time see does and the that

Paul Matteis

Got it. Thank you.

Tony Coles

data you question major anything add to could on the in KORA and on And that? you depressive pick totality if our would well up JR, thoughts as the disorders. of

John Renger

days other Yes, transient And think, with the been I'll your part not just Paul, add may dosing question of -- one have the of multiple note. there. I over transient

even a So period. seen we've within XX-hour

the And So once-a-day design, blood at doses. the we had XX. collect think day, we at at twice to the covered the a Cmax, dosing done you had BID capture study and a to XX be to both mgs if subsequently, BID back Cmax to pressures dosing a

we didn't at with it effect a see data. So was transient single-dose maintained whether

posted clinical and about from now confirm add recent KORA in the setting done question to seen were in confidence and was the recent the -- we've I'll preclinical you So studies the ClinicalTrials.gov. we EMA in that version that. depression the in just had -- study the the previously was results transition in that over our what in that of previous study the J&J I'll

that J&J I yeah, particularly you two studies those So study, mentioned, for the guiding that are very us. think

about thinking the forward. we're program Now taking

picked and the J&J occupancies, of well-done they and that about necessarily how receptor they how the actually where for pick their really confident doses the they what in results we're talked a they how are from then we really to study. in paper us. and follow receptor seen prior they've occupancy We doses exactly there won't the their piece to got did, forward. translational that a they excited And data see As was this that about Obviously, also study. you know, depression data was to publication understanding approach very publishing is go actually but the they guidance that the depression

think based we it, how we we we on think what about about proceed need. our circuitry patient So excited on involved I will here I the think also spin we're understand but have the own in

Operator

Wainwright. Douglas Tsao, H.C.

Douglas Tsao

maybe And that sticking and accomplish early-stage just just I in hoping just molecules, the with what up bit those pipeline. program what you a the you're could of to does little clinically? MX about emraclidine, to was more open talk maybe and given potentially what we've to seen sort trying accomplish you

Tony Coles

Doug. I'm all address comments, mechanism, me couple that, as but have it's effective. a least than make going always let advantageous commercial particularly the a a been one mechanism more to entrant the with my years guy, marketer of at if as is to ask of and JR From same

opportunity cover assuming us we with generate So positive potential even MX I agonist, to the us clinical data the gives the opportunity, in indications neuroscience of an an can space. gives this think number greater

advancing a I interest add an that strategic entrants is by multiple level, we indication to specifically talk schizophrenia just that are of with -- to can much emraclidine, work the in mechanism, the And to add I we some attractive. to the and a fourth related multiple and offer vision franchise very if wanted kind have for dementia-related potentially with this but disorders, that a would potential about JR, have please other can doing complement might what advancing to MX related higher think JR multiple really agonist psychosis, details mechanisms. that that. which be us. as certainly and potentially even of third in we about

John Renger

a that background. things think the here in couple are I of relevant

all, treatments very both the a start group, in working our a molecules the think wide we've what considered you'd various think have pharmacology. I it of you group, you we've well first carefully the the types So Also, as with potential some a in that treating are there's to and at exceptional fact new done that and in have current the of really chem] closely you is vivo ability for really that our can very what with PAM. when at and a that made is psychosis indications of used biology indications to group, are MX-selective different are mechanism pursue, look [med clinical range as various about look for obvious group, that

the believing that another we've very outstanding types a the schizophrenia treatment the break with to seen what have certain certain think if you rationale know a and at is what about in psychosis start disease. dementia in classic results where is clinical for with for offset, -- at manic is that that So see for even certain is typical previously population was in. in that Alzheimer's of practice, are patients actually initial that there the clinical there atypicals, strong patients. associated looking are psychosis that in We doses psychosis severity very instance, we're the practice interested one of high But to a actually at very you

we've one clinical doesn't models, a provide to get-go, with with that that hard we a preclinically It higher typicals and agonist. on possible really -- the receptor as and doses from there emraclidine, opportunity today think the to indications really, And about being what even mechanism, of MX populations expand characterized as thinking when hit benefit. you're you hasn't full titration believe required in real is are clinical knowing potential in so and this atypicals the how used about certain at practice and our would

going a layer is we on actually pursue first have that mechanism, some of at do start when we particularly weren't the help severe around of And you franchise titration, can MX that starting a tolerability. what important indications agonist, full patients dose we've learned with think the But is indications in build it's that selectivity, how to with psychosis. the those this of you most emraclidine. that can really with So after us what types that that optional we're

here. real opportunity based build the a opportunity Crossing, opportunities we the And to characterize labs you. make preclinically here, MX that upon create single that real we here we as build show leading that think science because see Tony we molecules saying. was them we to been how new differentiate a research to and a not we've opportunity franchise have at Cambridge on just selectivity and a So have asset, new Thank we with and actually in the have

Operator

Sachs. Goldman Kumar, Madhu

Unidentified Analyst

This on Omari for is Madhu.

couple a have We of questions.

looking on then any second on question you you're prospect. the to the population a target can anxiety? color particularly epilepsy And darigabat provide So trial pursue, at

there's Just to trial patient just nothing about changing, total like design that's clarify numbers? so

Tony Coles

for said remarks anxiety darigabat where we a are the the there potential What in for we at be is anxiety subtypes, of to role -- disorder. seems darigabat. sub closely could panic That be one very looking prepared

So into are This study. very no of processed, are teams a trial, no, clinical And studying analyzing is our the carefully. epilepsy just matter getting patients there changes all them data. the the that trial the for and getting

in no update design. So new trial

Operator

Stanley. Morgan Harrison, Matthew

Won Jung

Won for Matthew. the I'm line Jung on

about two have One we is emraclidine. questions. So

preparation? The even about So nonclinical which is XXX. any X X work other completed, impact is question needs Phase an to second could have still relative be there Phase or to on

you or you be, that expect could just are efficacy? picture clearer robust the be how trend So or envision a you expecting could could a signal of

Tony Coles

talk address you you on emraclidine? remaining Ray, to And would that's JR, the I'll XXX. nonclinical get work about of amount

John Renger

ongoing. work additional is there So that is

studies know, are cell] [CAR required that are the those And typically actually years are completed. studies longest that in part have to be studies, of as we've you package. registration two started duration So the

about we've to make if preinvestment tox them additional path. whether preinvested we off time is two of possible. do we period, that a support think and additional studies we package of go sure starting preclinical at critical time So actually determine have that there's feel we agency a very in talked not getting things feedback any we these preclinical when this the to And done can that they we've get with things our short is they registration, in lot experienced we'll move studies. But very in as the next can those group, or earlier and Obviously, do package. a take do complete will were of rapidly that the we to the one program will as that of that the back one

So but that agency to in not critical of questions studies thinking be always on those might they're that time standard path. we we'll fare be additional addressed. have, those able kind make to sure been may answer the done get There has can

accordingly. say I opportunity it place, is to the there So we in but and and would agency hand we'll always plan the is for feedback, get that respond well on have an

Tony Coles

can, efficacy -- don't the talk why there. to -- efficacy tool outcomes and using to just do trial let's I question with second has clinical think we're from measure if Ray, XXX you the the

Ray Sanchez

apathy know, the of symptom of predictors is you one the neuropsychiatric symptomatic leading strongest as with disease progression. it's So associated and dementia,

we operate DX/X see tone. So great utility that brain, lower partial operates this agonist the dopaminergic areas that under in in of

closely very better trial So this our with of we're goal really that agency in this utility understand we're the a Phase now, Xa to one, doing working therapy is population. the which on conduct to

at using per of used been to endpoints us trials it's been of so trial variety scales apathy, but XX at endpoint it this experimental also in the occupancies. an and to XX% doses looking are is historically variety and have actually that methylphenidate and scales, really and a but achieved which ADMET used primary se, in milligram of receptor XX-week past. X patients with had understand milligrams, trial a And give truly X an the understanding looking there so no conducting XX% with And we

when first of path agency The would order kind to with look good Fast half we mentioned done to to the work earlier, be the be since of at which work would is validation to very then in so closely approved assess in these in stages Track of the allows news we'll the data, from forward we'll look FDA, be to order what the I therapies. data us work as will at read need And what XXXX, to there that, development. these with designation out no later will endpoints viable progress received which are and them

Operator

Berenberg. Hong, Esther

Esther Hong

could study any anxiety Have the I we you has regarding So in Thanks. if FDA patient anxiety. with when about expect was the disorder? them wondering on guidance wondering trial darigabat, then design. for was X spoken And the provided the enrollment Phase

Tony Coles

next work thinking talk our planning how the for we're and you about anxiety? Ray, darigabat can steps about

Ray Sanchez

earlier so I on the X But over as Phase weeks had to sure to want agencies which their prescriptive, pursuit with the fairly XX trial. views disorder, panic trials and in change stemming they panic obviously do highest duration, mentioned historically second just XX attack that be of thought We So course, time. meeting still These been aligned. forth. will are proof-of-principle from looking at anxiety make plan since, disorder we frequency that in first anxiety agencies' process likely our is the after generalized the disorder,

So have be clear. we well. agency the will historical forward we with precedents, that to be yes, the And ensure that disclose at that that course, process when we will, path to is following of the the as will internally look meet clarity

Operator

to further time. like call Coles There Instructions] I remarks. to this closing no [Operator would for Tony is Mr. at over turn the question back

Tony Coles

you. Thank guys thank good. us. for joining Very you Well,

rapidly months As the as interesting KORA, what And for the for that very progress are towards complement you making we pipeline, you lot work later-stage both a as good MX a Cerevel, on data we're here early-stage of there see, really and advancing very the to in registration. is, see at well come. we're as towards in readouts expecting the can lot as that always, agonist, some clinic exciting will that going will

for and call, that, and a Thanks update really listening got today So we the do capital forward creating next you focused appreciate to our with to value. great the guys enjoy team everyone, joining and day. you. is look We've on very

Operator

all concludes you. for conference Thank this Thank call. you And today's joining.

You may now disconnect.

Cerevel Therapeutics (CERE) 14 May 222022 Q1 Earnings call transcript