CERE - Earnings call transcript Q2 2022 | 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 Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, you will have the opportunity to ask questions during the Q&A portion of the call. Please note that this call may be recorded. the Strategy to and hand President Calistri, now Corporate of Investor will call Matt over Vice I Relations.

Matt Calistri

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

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

Tony Coles

unlock expected year robust Phase program has to way led data second new apathy. early and compelling panic darigabat and Good potentially schizophrenia, announced for And of emraclidine living programs aspiration Alzheimer's broad even joining leader which business emraclidine, that set and the to have distinction to medicines millions us XXXX quarter people to schizophrenia, with pivotal our new X we well of additional call. in neuroscience study epilepsy to and of a with have the that a deep you ways Parkinson's, in on programs, intention results high potential of mid late-stage a today of next we disorder, are morning, in pipeline neuroscience to to and of among early-stage a hold II dementia-related peers with rich advancing Cerevel, We're company for initiate achieving large portfolio. data certainly in depressive with believe the readouts unmet programs psychosis our more bring pipeline is thank disorder our transformative disease our become and everyone, us promise programs value conditions. and in our major unmatched need At other it's for that this we our

just promise we're to its an eager innovative psychosis, potential in a working treatment potential to The committed MX and ADP. potentially do of as receptor, late-stage year, we data acts For focal pharmacokinetics ultimately, Alzheimer's disease, a has explore other programs, many the Phase advancing we with transformative milestones them MX paranoia aware Phase epilepsy an we novel dementia-related hallucinations for a their milestones, other expect possible mechanism our only end bring mid that neuroscience. what's the to as Phase apathy. patients soon a in both John new of emraclidine's delusions, indication of as of after we X to suffering agonist expect the With of to to with tremendous X And an bring and an new XXXX, the before darigabat the development a the next as in time, in the period we transform those and volunteers tavapadon pathway. Cerevel is positioned opportunity data for MX to And in size first readouts and possible likely And readout and CVL-XXX, entire we years. shareholders sobering, that so closely the broader conditions. its evaluating this future by II developing our to in ADP tolerability communities. of have disease not elderly readout III loved a many leverage rapidly this and behavioral a a innovation as in new mentioned, individuals Alzheimer's safety, near-term that as to to exert for Parkinson's II to to have full emraclidine, intend this readouts following in as basis potential emraclidine, more and tremendous. The upcoming or to part targeted toll MX-selective schizophrenia, over seek With our schizophrenia holds order this Cerevel, in value conditions. exciting half of at adults advancing Phase patient initiated initiate remarkable in most likely with In I program, program for moment. and second important from provide additional times all we therapy MX-franchise this this homelessness well suicide. enormous devastating healthy for leveraging pathway possible. modulator, we're be PAM, that readout trial support X.X such seen data are additional XX in program as as or of committed we program ones people June in in condition II with We're million as than also potential alone loved investigating allosteric in for living action, which promised. to program to disease our works. II to the experienced families, psychological need unemployed, already Phase more approach on details dramatically Phase on not selectivity and novel we're on and is in symptoms this Individuals accelerated living More muscarinic are We're area We're U.S. die very emraclidine in will lived in positive the a therapy affects they're Renger schizophrenia. targeting a XX

of The story, Our for work only announced alpha-X/X/X with Earlier in the selective darigabat, year, since ADP that pandemic, generate darigabat the PAM. to alpha-X the time, sparing minimize our the to the trial activity, targeting need. in the Anxiety anxiety of episodic side data years XX%, worldwide panic likely In though. the staggering is have that Cerevel only benzodiazepines able and increased area than this to at first unmet part have reported. compound anxiolytic innovation and can another year in proof of effects of anxiety COVID-XX we alpha-X/X/X is same of principle we seen figure may passed by and that higher emraclidine clinic GABAA Related disorder. depression alpha first schizophrenia demonstrated is positive for be treatment use. tremendous a one and anxiety, a and XX the limit time,

trial additional evaluation our of this indication announced anxiety behind that the for of darigabat we Following results today selected our epilepsy. as have earlier we year, disorder an panic

face I'll we the deserve with of strength turn Sanchez, driven neuroscience. remain second deliver our Cerevel late-stage clear who anxiety most to need have pipeline about diseases new further disorder the the be has potential future debilitating. call. lead programs, the provide to his important with common purpose to specifically of advancing our Ray? changing most is over and and the the added to Medical believe our comments the some treatment living our and a neuroscience Ray at programs section and pipeline committed in of call is our options. can to Dr. As individuals We more the medicines Sanchez Chief Cerevel by Ray now and color is Officer will

Ray Sanchez

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

neuroscience. As is Tony has positioned to well outlined, new frontiers Cerevel open in

medicines diseases me off-target bring enhanced the forward to career tolerability many neuroscience. new to address pipeline side what motivated what challenging clinician industry. with I I'm and years possible by transform most the some is into as Our profiles. energized effects a and our fewer far treatment so life with sciences eager transition and seeks excited the results and in for neuroscience need in is a spent to of options better

Tony dosing to we two trials, the in we see in half eager II expect XXXX. in trials initiated with am first schizophrenia. emraclidine EMPOWER I both mentioned, patients which recently living the delighted I'm and these of are adults we results, As Phase of that

doses For Both meaningful background, effects with truly gastrointestinal the Ib side statistically or Phase antipsychotic significant were demonstrated emraclidine data impressive. clinically announced effects, symptoms last with weight we differences placebo. meaningful year in gain compared extrapyramidal and no

psychotic Phase robust conducted with adults as results acute each exacerbation these our powered schizophrenia conduct adequately trials. symptoms. and we are encouraged being X-arm These living are an XXX of enroll trials will two II We experiencing worldwide and very by

placebo, parallel In extension data EMPOWER-X in monitoring the from versus range us groups emraclidine the schizophrenia minimizing number to The the order the We evaluate inclusion milligrams XX-week Running an QD what in response. criteria FDA variability the the these by will with emraclidine, and third first with and schizophrenia, often expect with emraclidine will to observed milligrams These service hope quarter versus diversity blood dose also of trial potentially based XX with and pivotal needs package. arms meet expected trials, X-week reinforce we of the of and second reducing test the living expect registrational of milligrams to accelerate to test enables XX conducting placebo in of focused fully ambulatory while QD well emraclidine initiate a will in we therapeutic a XX QD clinical in registrational the end commitment two these also treatment and the open-label designed underrepresented QD trials as as emraclidine clinical the a pressure of trials of trial trials. package on the in Cerevel's in explore XX individuals milligrams trial potentially year. are placebo. to trial trials necessary to the safety XXXX

as Moving in life a now the management of potential emraclidine Alzheimer's opportunity. cycle psychosis disease to

stress, will safety, trials panic days by by Panic X ascending is attacks, elderly X X XX which to trial The healthy design disorder, evaluate pharmacokinetics anxiety a we cohorts characterized As trauma, doses, the year. second is potential common to illness. presents lasting now tolerability I'd the heart treatment impending XX initiate dizziness, in plans people making experiencing can in are milligrams by be dose the chest rapid of old end and disorientation to rate, mentioned, and the of Panic our episodes attack. heart some our they sense volunteers XX of which most bit or Phase a share a this like darigabat panic disorder, about and can constellation fear Pivoting Tony I pursue doom, multiple including weakness, of include to like plan information evaluating factors, with debilitating panic pain, a triggered years even pounding various be feel that to XX more symptoms disorder. as a to each. quite for disorder.

II We developing on be the the currently trial, FDA plans for our our path Phase proof-of-concept meeting fall forward. and with are to alignment gain in we'll

our will progress. as We plans additional provide updates

many this the darigabat's results reminder, in panic as better plan there tolerability encouraging suffer know disorders, acute treatment treatment from options. the top from for minimizing differentiated I trial need of our hypercapnia positive contrast a year. on and disorder These darigabat evidence volunteer daily As potential to people anxiety in benzodiazepines. are concerns a maintenance We while comes anxiety-related data line that of provide heels who strong healthy very Phase this earlier

panic of limitations the efficacy for treatment We their hope side sedation, a daily the maintenance is limiting needed our be much tolerance to providing cognitive also relief. for with that use. goal understand attacks, abuse with impairment, Consequently, people potential chronic and darigabat benzodiazepines managed with include inadequately of effects

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

on continue dose collectively Phase of in III all trials, to trials our as and X all the TEMPO known track. We remain

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

our are we in partial which trial agonist, Phase IIa to Turning in evaluating dementia-related DX/DX a exploratory second CVL-XXX, apathy. currently

of frequent and enables expect well for with in last We as June rolling data first XXXX. indication, more the and as in received this priority year, for Fast Track which the NDA designation half we the interactions submission early In FDA, potential CBL-XXX review. of

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

John Renger

by morning, of everyone. overview and the Ray, to earlier-stage part of preclinical begin clinical this an you, presentation our programs. I'd like and good Thank providing

potential agonist its indications. an to program additional also have industry-leading the an believe complement consider as therapeutic in active mechanism novel additional this for our MX presence identify will this MX of expand an we in We as provide program clinic-ready of to emraclidine of of demonstrated This First, creating psychosis. give asset to develop doing and selective neuroscience additional we optionality action therapeutic are utility opportunity we what goal selective molecule part an and treating us full indication clinical franchise. our will

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

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

you to disease-based our by We and develop world-class career of molecules this efforts with come, that We is on these many have to earlier-stage neurocircuitry appropriate. chemistry to scientists driven address understanding some engine, talented explore the for research as on of able potential most fuel in I need. progress are differentiated we which our leveraging to to patient therapeutic innovation look believe been forward major work keeping my of and the years unmet and to updated small

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

data Meeting. disorder achieving indication exist trials. of have recently Annual we of also presentation at positive and XXXX I presented potentially diversity, American including trial diversity our how panic redefining in on our Cerevel's the participated inclusion disorders. in pursuing a of And diverse our on Phase the of envision hypercapnia this all inclusion enrollment focused and operational touches ASCP, enthusiasm teams for equity aspects of At our Clinical and clinical underscored Society the panel barriers populations. can treatment future Our the we darigabat discussion to mosaic organization, vision Psychopharmacology clinical broad that a anxiety

informs of focusing from both about have We developed on the considerations participation may healthy communities. and seeking that populations with and trial impact our in precedents a distribution and diverse patient-centric investment thoughtful cultural advocacy patient volunteers, demographic clinical engaging guidance deploying differences input organizations, addressing historical when

authenticity relying all equity diversity transform and principles we for design for develop like congratulations and my diversity, trial how inclusion service our solutions to I'd enable directly mission thoughtful gratitude neuroscience like Officer, and to on and push Bodenrader to Financial it lives who to are Mark their Our performance quarter. embrace over and patients clinical extend our our first to diseases. with publicly Chief reflect and [second] boundaries, in the mission company, review for I'd (sic) our us. hand commitment patients teams the Interim Mark? to Cerevel's for to our financial ongoing now

Mark Bodenrader

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

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

million other our tavapadon, was quarter expenses approximately by second discovery quarter emraclidine, to continued our expand first was last program. over increase primarily Relative our by continued to associated As efforts for costs This $XX pipeline. and the increased our by advancement and a increased and year, infrastructure million. in capabilities darigabat personnel and $XX preclinical we to advance due grew expected, grew to costs and of R&D the progression R&D the basis, support quarters, programs, of the investment our expenses total This clinical over costs approximately second prior expense increased primarily the pipeline. our quarter quarter due of as advancement advancing emraclidine operating of the personnel to XXXX. trials with On driven sequential

relatively R&D year, the expense G&A our over be costs, $X expense year the expect to our quarter approximately We we second grow to primarily of second due for last consistent continue results. increased by remainder for the million quarter to personnel higher with as organization.

our year, expense as we company, of We to our expect G&A the continued the programs the planning of of including the progression our growth for and commercial slightly R&D balance activities. support increase

closing, totaled our $XXX XX, XXXX, cash In we securities equivalents approximately and capitalized. cash, remain As of million. June well marketable

resources cash opportunistically call We multiple sheet. XXXX. the couple into look Tony readouts that, data and forward our our expect think continue back remarks. and our years for strengthening to of we closing creatively We balance next operations I'll further current value-creating about the fund will to to to over With hand

Tony Coles

Thanks, Mark.

development As can is advancing near-term of both late-stage the questions. therapies. the also and the neuroscience significant that, these we of with extend and robust believe participants for the shareholders. unlock the open plans that I XXXX, to neuroscience our three data coming truly I joining in building vision let's trial of call five broad programs to and you range to clinical Cerevel what next leading is appreciation this company to see, of optimize to contribute and cycle you a thank broad to becoming potential us transform edge patients Thank set dedication deepest investigators want frontier and in make medicine. readouts operator, gratitude want With And this diverse our With who we're value great for premier therapeutic a for and set across commitment my possible. indications diverse each morning. and on whose exploring the to up of diseases, management of important programs we're treatment our in of a life programs teams the development

Operator

comes you. Thank first Michael Instructions] Our from Yee question with [Operator Jefferies.

Your is now line open.

Michael Yee

today. and So about little of morning. the ask is wanted to you lot wanted hitting indication? drove I and of feel And And as to you regard of there think a forward some And just to you'll how that emraclidine. update say pressure announcement Good follow-up - what on that are later what Tony, understand on you. what maybe how psychosis. about just about for Alzheimer's reiterated I on drivers will just here? this MX year. think, know study, the the an expectations actually updates. move important going guys. in what to is today, announcing that blood Thank Thanks confidence. have a on that, and study? the A talk Hey, I here. type in just guess be that I then the for were you guess the emraclidine I able what that maybe also, And bit of you

Tony Coles

Okay. for the morning Mike, question. thanks and good

questions darigabat the for our I of our in anxiety working next updates. about steps your was got on of been think pipeline one earlier the data We've year. announcement after this we

certainly just to ABPM cover pharmacokinetics regular and to going with panic same what planted today just the ask carefully true announcement and add And perhaps With next of elderly the people keeping development expect Ray? the the updates. everyone to dementia to that that regard can of program Ray darigabat either our the that is emraclidine is from The before more a for been this have panic in And disorder. to year. can are now I'm firmly study these full pipeline that ADP. we our part notably what quite now just emraclidine latest a very say looking while. additional is our said our thinking to we later any Alzheimer's feel lay or psychosis. on this wanted for darigabat steps. in We've about we We've in out and feet study, comments healthy at So prepared free Ray or apprised opportunity team

Ray Sanchez

for you question. Sure. Michael and thank Good that morning,

the You trial as that this monitoring I we year. are expecting results blood pressure of are, ambulatory mentioned correct, the earlier, later

our a a know, guidance per in As that that you their pressor that that But no they over transient, pressor weeks six those the shown remind development. meaningful and or is Phase end any effects were I differences showed effect week therapy Ib required of versus time the at just average trial minimized Phase trial clinically placebo. to six you has is for in

interested required trials pressor to really Phase is for The we. an So as know, trial the pharmacokinetics guidance systolic over I from is X-week as in And the other effects is pressure period. a like in blood understand this interaction that - are agency understanding trials, you drug-drug sustained well.

another to registration, So approval. for that is it's gating is just trial required but not

terms really inform how practitioners on leverage emraclidine patients it's it's So to to approved. when the best and of labeling in

Michael Yee

Okay…

Tony Coles

if know had could ADP Mike's the – You And you the question, expand in selectivity think I do how of to on the do thanks, mX? what with indication MX maybe we for about Mike. question think versus JR, mechanism aspect

John Renger

question. Tony. the Thanks, Thanks, Michael, for Sure.

So as that Alzheimer's pathway in benefit [ph] and drug and muscarinic you outbursts, early an the very population itself the in vocalization, patient some tolerate a study that paranoia that had with could that - by anomaly had established the patients measures. a in demonstrated other on early was know,

driving we with in believe receptor that's it disease. dopamine levels hyperdopaminergic so the that's Alzheimer's associated psychosis is MX the really change decreasing the activity And the of part

have shown there so you gone compounds they As have benefit. into prior Alzheimer's and terms compounds that been with MX know, cognition, not of in companies have

really that able we'll and symptoms selectivity think looking what patients. is psychosis Alzheimer's be efficacy drive we to the in So at the really MX

a finding benefit. indication. pursue as we we'll Tony. this Thanks, confer so out MX And that But don't believe the we will be

Tony Coles

question. Thank we'll next right. very you, much. Operator, JR All the take

Operator

Matthew Harrison Morgan with Stanley. question Our next from comes

open. Your now line is

Matthew Harrison

Good tavapadon, question question. ask hoping was Thanks morning. on taking the to for here. Great. two-part and I I a guess

to terms the read you view meaningful have then just PD in results PD and a to - to talk or Thanks. going in before of And come two, is separation how TEMPO-X can what talk early in And studies? result view through those as secondly, then you obviously, a first, about you about you can first not? So late TEMPO-X. clinically

Tony Coles

Ray, all, of question. - you'd thank just be for if Yeah. first kind you, the enough Matthew,

program be think, draw the time I Ray, perhaps TEMPO-X we would in a next and that the just half the in and data year TEMPO we between this X the distinction expect that half the TEMPO-X year. of to second good the the overview of and first data expect

question Matthew's consider to the question read results and we in might focus. in a think TEMPO-X about I success. - to potential standards the main read through would then the efficacy come of others And be we'll Parkinson's for what specific the clinical

Ray Sanchez

Matthew. Sure. you, And good morning, Thank Tony.

inception disease. So this disease. any we been Matthew, address novel of the tavapadon years There being comprehensive to the in of diagnosed of a And have we benefits all think program as novel you at the the a symptoms address the therapies last hasn't the really mechanism. will Parkinson's know, of throughout is XX that course

adjunctive levodopa. So treatment TEMPO-X is to

the endpoint one troubling without primary meaningful if the on clinically least at time hour. So of dyskinesias threshold and there is the

powered of at accordingly troubling time it's one achieve to So hour on dyskinesias. least with

III, disease the not expect as in we the you XX-week terms so different in the read robust several we Parkinson's XX-week trials early UPDRS the trials. another trial, Parkinson's a unified very endpoint II the rating in III. primary of ago. years differently and are really Those powered balanced in outcome Part in saw that scale. is was early achieved the trial look impressive those was to through what X.X And at, know, which In conducted And the Part points on is

motor that is benefit XX the significantly can a weeks but that only II. as improved of also So in as assessed and on Part not functionality the the the in patients our show hope we symptoms, by

backbone again, So when will really my collective our of the diagnosed earlier of benefits the trials to hope that's, show therapy from tavapadon comment course you're going inception being the disease. back is throughout its of that the a

Tony Coles

the as topics? haven’t your on might think expand we minute. you some about Just And standards? a competitive how Maybe A. you met Ray. add to think about launches profile, perspective those just of commercialization, Thanks, why might the want existing

A. Ceesay

Sure, Tony. Thank you.

package is, one history a is need. reflect Parkinson's look have come unmet of on strong the patient of recent the we spectrum I as tavapadon. and Early as stage Parkinson's to There recent Ray much up strong One commercial this us. profiles about supporting couple also of offer population. to mentioned, which us introduced led hasn't tavapadon Parkinson's we most for, being the mechanism Parkinson's ultimately, also the mechanisms there to action commercial we not as really have When of when across well, Ray outlined, initiation, And actions can lot base been well we innovation. been continues we think that launches at robust that really patients of potentially step Parkinson's really Ray therapies that think we but a therapy has we really said, will a novel backbone through been to the in the tavapadon, as supports, back significant look set of novel things data we think and space. launched really of therapies, things see kind to haven't of a that at So patient a of benefit And really presentation patients, population, presence disease. core a but a very as think, those

Tony Coles

Great. next the that, let's Thank operator you, question. A. take With

Operator

Thank you.

next Our with comes Matteis Paul question Stifel. from

now line Your open. is

Paul Matteis

one on the compound. and so Thanks question have kappa emraclidine then one much. I Hey. question

curious mercury that through disclose study goal primary blood process by little meet study? a mismatching above comment kappa data why the if yet compounds, of upper you're much. that of ambulatory data to a I there pressure the And in confident was walk direct J&J wide statistical are Ib, the thought if rule around in of on bound small your given just of that study the I pretty you soon going to the think goal you've pressure, that statistically the a there you're to X%. Phase understanding Maybe have comparing? end sample plans the this from disorder, they we're in the have Thanks bars think the you blood size major kind were study depressive On points in that kind the math and in this might that monitoring the reflecting some said you I then to on time or likely bit so error - could year. is increase somewhat you're regarding a under radar? millimeter Can flown out X is hoping

Tony Coles

are you a set There for Ray, context aspect we Paul. to of level question, X don't Yeah, of that. your provide thank notably, from good couple study. everyone. question just the and the things probably mercury millimeters why for morning, [indiscernible] And of the your

understanding a have I about we from FDA. Phase requirement for thinking particular a the as this So study good

Ray Sanchez

mentioned that per So trial that for I you is in I good effect Paul. shown have pressor And know, morning, Phase guidance required their agents as is as that earlier, this development. a

it's so we're blood I is given labeling, any the know, there weeks. the the it's inform other gating registration that's trying to And required what another trial any the trial Phase for really approval. not at time, really but but X to to I Phase like effect And as a absolute not systolic here pressure X over pressor absolute, you those sustained effect really weeks, over is understand

to - XX here dose. is the at from X. and pressure high so X or the dose as X mercury goal than show correctly, And XX% XX-hour powered to really a of XX% doses so of understand, systolic and over millimeter there blood sustained greater for of XX look baseline time ambulatory for milligrams, a confidence at And week a you baseline milligrams that change is low mean it's mentioned probability the to and interval a really – effect powered - to

for understanding confidence again, looking bound is. the that for outcome And informative looking is so looking what the registration. But at for dynamic it labeling we'll and be this what upper understanding of and needed than more for is but be really the is agency approval, will it's that for, interval

Tony Coles

asked the to want know of not that the of to in blood draw is, one that But is had course, subtle That have points point pressure. to sustained did study you because in this really so to the everyone's you don't more episodic any that because Ray, pressure. if it's clarification, not and add that just but said millimeters that, that increases increases add I is sustained X in question fair know agency particular I about blood cares attention this beyond blood what of of wanted think was, in we the I I I think Mercury. the distinction. elevation about about you pressure

Ray Sanchez

No.

XX-hour blood I at think week at looking monitoring and really what the the versus pressure is using baseline. X we're

who trial, that describe so average Ib able it benefit need understanding of then And during benefits if But for the Phase of we XX-hour emraclidine be concerns a look but really to are patients that is will important. gives we labeling, emraclidine measurement average the the data without the in in at the overall. that that pressor it. week X great confidence the really we'll what's suggests But inform we that case has effect us differently, confident still

Paul Matteis

data study shown study, closer could max I just of you've was point time I clarify, XX hours. this far, what Ib think the was that so And versus, if that C the Ray, taken? to in

that Just around in the trying context the X understand to we saw X-week the data day?

Ray Sanchez

Right.

points, of hours X in the - taken - taken one were they was it but So post were measurements at dose. several

C daily to at max. X. the that data X-day measurement closer we showed average of So was the week The

really because to show that's want see average what closer is XX-hour over Paul. so the period, to a we'll what And which we shows will in time, ultimately it

so And the point. at of the to not effect effect an acute given any speaks sustainability difference time just in and that, the it that's

Tony Coles

was C that And involved team Any know study. maybe leading in program aspect that from I around our few I would answers has core Phase intentions the question, additional the lateral on to comments that into Ray the complement max your often. what the JR, MDD? of in a for just

John Renger

And Paul, - Yeah. the Sure. question. Thanks, thank Tony. thanks, for

weeks X X-hour was for the point. reported was at time that data the So

so to what And C estimate based on what we've that is be average max, we seen. pharmacokinetics,

really when at is maximize C looking you're which we know - is see about worst the that based expect what transient you what the we on so the see max. increases, did to And what it would deviation

a have over consider saw first in worst And the to you effect was away then goes you days so what there's even that of take is that the we what And transient can you transient see. that fact dosing, if effect the time.

your you're but time where that point, a anticipate to point, period, we be have millimeters KORA. so this that. the was about C And be. and an over X To XX-hour reported that in averaging we'll confirm at estimated you've we'll the We data seen area around could if is – this study what know, around you the worry the it But max second the at Paul, don't doing point? we're to worst

about So very excited molecules. we're our yeah, really

in has clinicaltrials.gov. So data there tolerability GI a in have as reported study that II positive around depression. studies design do know molecule Phase additional We know, with J&J you that are on been reported their

seen in and from molecule preclinical the on tolerability Our perspective based and we've date to safety a very talks promising. what is clinic

tolerated, the we're well within that so its study. data back shows very that And a you know, getting SAD

feedback maximize So to to understanding in next and looking completed those look far steps that getting the the how and as But being the engaged that we considering we're giving portion. dosed help> Obviously, like us we're our clinical we're for what is next on to be what will MAD based I in those the steps very Does next of we're the what options trials as data once study. able and and seeing indications. think the are molecule we've take SAD planning forward designed

Paul Matteis

color. it. all for the you Thank Appreciate

John Renger

Thanks.

Tony Coles

take next the we'll question. Okay. Operator,

Operator

comes Sun JPMorgan. next with from Tiffany Our question

open. is line Your

Tiffany Sun

next you Thanks key morning. for steps the provide moving guys. on emraclidine, some Hey, more Can Good for prioritizing, forward. question. mentioned the you color

So the the expected what's CMC gatekeeper what pharmacology expect safety cetera. of manufacturing time one these And the XX-week et more broadly, be scale-up, approval, for these to non-clinical Thanks. and safety and for or trial? the do you studies, lines

Tony Coles

the product the don't overview that you, development think to you answer terrific. Tiffany, to of I'll II able would if ask of And about, be respond, I talking Tiffany's two Ray, that Thank we'll question. JR think side. you be program the well, for and But providing been we've Great. Ray, JR the largely an CMC I Phase mind questions. in

Ray Sanchez

we Tiffany. open-label you into morning, program trials that opportunity individuals as as well Phase as mentioned, roll X-week schizophrenia soon Yes, consists two that start that have are conducting of so the of to Good the the Yeah. II a XXX which open know, to since each, slated label, extension. over robust as is we these XX-week with individuals living

file are We the ensure in are supports, Bulgaria, will patients fact, adding between in to in have They to both Serbia rate supports not become for de separated we data in in also does dosing be novo being the limiting the future the The both trials, and able we've the that, indeed, if registration. our extension been open-label trials. data conducted U.S., - But potential started countries two being trials. Hungary. to

work a dose that's And statistically characterizing from full believe -statistical we're separation as lot understanding and long-term of perspective, then, range, we're of package and can hope John soon conducted get course, and that But patients is, we safety step provided in out data as There's forth a the of which agency well that preclinical if course, other with looking So the emraclidine meeting it showing the outline. possible. terms work we but is placebo. what try work to agency will, will our - that support, to as being lot from for, to data, operations John? of have doing. and which is But, reads the pharmacokinetic the of as that that technical their a hope and be we can so as

John Renger

And Ray. you, Thank Sure. thanks, Tiffany.

the et being successful a so we the of data from that work the work from bring qualification manufacturing all stability the all done have able perspective, tech that package work. support necessary to cetera will are controls, to preclinical ops tech if being ops so the registrational we forward yeah, positive be filing that a and So about and quality and on very comes NDA back aggressive

know, support points. around that NDA an a [ph] you key that one work will things the lot work, the the submission usually is kersey takes done of the time of getting a to time be time As in we're kersey data other

FDA has it's indications, OLE I meeting to about package that studies including in very population. elderly been we our think with around extra the had the frame the into plan a your the track so deliver the the initiated, And we've expect complete, for NDA to necessary time that [ph] other on question constructive going submission with

doses that in covered As forward. under be population healthy Ray same that mentioned, will the carried we've

the XX-milligram dose from we've that including that up the which we be to we'll highest dose that so think announced the achieve, milligrams of And that we study X in to is today. type need

excited ADP. population And to cycle or in safety life support get so elderly we're and in that tolerability data management to the opportunities

So manufacturing we to the a commercial on vendor support compound to all do have selection support scale. this

successful so studies. data the hope I the And Tony? Phase they a helps getting once have positive ready work from to that have II follow-up we're

Tony Coles

thrust when that ensure is ready everything we I with clinical we're data perfect. mean doing the No, Yeah. else. the ready, can think that's I to are parallel everything are in we

So next thank question. you guys Operator, for that.

Operator

comes H.C. from Wainwright. with question next Douglas Our Tsao

Your line is now open.

Douglas Tsao

taking questions. Hi, good the for morning. Thanks

in a think study? do Phase and have I II darigabat just panic the on I'm primary of the the with endpoint, dosing First curious, X-day the sense study you duration and - acute endpoint disorder. earlier for

Tony Coles

sure, Doug, let little make me the got just because question a broke bit. I up you

duration You're booking study? asking of which about in

Douglas Tsao

study? the darigabat, the For panic disorder

Tony Coles

Yeah.

Ray, we what with the say? going talk has can Okay. all you want to indicated, do Ray, - agency. to details haven't there. the to Ray you we're finished But

Ray Sanchez

Sure.

historically, drug years so duration have you a anywhere as the XXXX, X treatment to ago. approved XX terms in there The precedent, for disorder of from been XX Doug, trials panic of been hasn't of know, So since weeks.

time, this and agency, align, a agency patients of any ensure disorder, of are panic we to the been a currently a the FDA. within will thought long trial We with our for to going that lot change it's fall within changes given hasn't proof-of-concept the finalizing been be there in to proposal that

precedent that make so sure precedent, And want really to that upholds we're But is aligned. on want the we and to just still for we sure currently. make our based obviously, program construct

Douglas Tsao

And a of the Okay. Great. psychosis. Thank in follow-up just dementia-related terms in study you. emraclidine then

that study are get how that do of anticipate I were dosing significantly Just thinking dosing patient-driven just - as testing from curious, think a you you for milligrams. going the low you Thank differ schizophrenia? think what and in you you've readout the what potential for will you doses as curious, mentioned I about study? to or mean just and you'll be you. X I'm John terms seen do

Tony Coles

don't start Why JR, that to is going your the question. program. with that conducting particular to you be team answer

John Renger

Yeah. Sure. Doug. Thanks, Tony. Thanks,

you that and need to before step had well-tolerated very go patients the We the next into as in know, a as we study. both confirm to ADP Healtheast. date So we've profile

elderly. the we full dose range to can what that in So we've a based know study in drug expect metabolized dose dose have we are that is shift the We impact the how covering in the announced. the response their on things the elderly multiple about don't metabolism and

that based cleared. a the differences get we profile we and data but we'll see about TK what we've to determine adjustment, that's the based the plan or going side date is to need on obviously, but dose anticipate what so whether know that's expect case, expect the And to don't on in the effect in. is We seen drug how

Douglas Tsao

Okay. Got it.

confirmatory of So exploratory sort rather more it sounds just is to confirm, an sort study? so of like than this

John Renger

I have to we the data. mean, get Well,

the the to date, again, seen sure we data adjustment elderly. into know would forecast get making would on what that a see in population. be elderly don't to to before we into But what patient go need date to is population have we'll the based extended we we that expect to we that something first. So dose do we've But we

Douglas Tsao

Thank much. Yeah, so you great.

Tony Coles

Operator, the Doug. Thank you, question. question. next Thanks take we'll Okay. for the

Operator

Kumar Madhu comes question from next with Goldman Sachs. Our

Your line open. is now

Unidentified Analyst

are panic thinking my on about This and is refractory for patients was is on How broader? target Madhu. the taking Hey. you already darigabat for benzodiazepines question. I something that for are just disorder. Thanks population or wondering Rob

Tony Coles

Ray, say our further plan upcoming and discussions Good. our we work? Okay. given can what

Ray Sanchez

Madhu. you, Thank right. Right,

that the of we'll profile is plan meaning the suffering threshold attacks from is and outcomes to the who have to and panic success disorder, are understand what the a panic really trials. they of course, that in and patients drives frequency, of So patient better have enroll is because something critical terms is

historical proposal on precedent. still looking be that internally, that we'll at are based We making but

So for soon tuned those we as details as align the we'll with stay agency.

Unidentified Analyst

that one Thanks. from emraclidine, on with then elderly previous population? thinking question population differ quick just Okay. And are interactions might you of other drug-drug any

Tony Coles

want you do JR, quickly? one to hit that

John Renger

Sure.

So there we've some excluded is as compounds. of the from see you can strong shift clinicaltrials.gov,

and inhibitors, so or there's inducers they're whether potential so And a that. for

that's We that's what have we'll be inform that not - we to population. something - unusual particular yet to looking but that, have the that's is collect, data think this in for. [ph] this But I

so physicians inform it there to And the data is about as ability, obviously, that, get that but should well. all occur, we

Tony Coles

know… you But

Unidentified Analyst

you… Thank

Tony Coles

just of expect because elderly don't the population. out ordinary You it's an anything

part that think second I the question. of the was

John Renger

no. is The No. answer no,

Tony Coles

Thank you.

question. next take the we'll operator Okay,

Operator

Instructions] comes Suvannavejh [Operator question Mizuho. next from Our Graig with

line open. is Please open. your is mute Your line your check button. Graig,

Graig Suvannavejh

you me? hear Can Hi.

Tony Coles

Yeah.

you, got Go ahead. Graig. we've Now

Graig Suvannavejh

end MX the have from least or clinical Thanks if sense wondering, at at especially on able Thanks been KOLs specifically we've between an done, have MX selective the the feedback Tony, gotten Also the the meaningful so lot and is of from emraclidine. for want doing you've what on MX taking from based been on done adjustment you to PAN PAMs terms compound placebo the a on I'm that meaningful difference much. was seeing they're you in end II day. score, doctors on get work on a of the with whether readout, I a really terms wondering wondering perhaps ahead company offers in an to see research what has of any versus market muscarinic your on what advisers our questions. of the [ph]. a And KarXT Phase agent of clinically - compound like

is thoughts III Karuna you Phase mean And So question might wondering the from so any are takeaways on could emraclidine? that their and we able Karuna the from my what for question And Acadia of just see emraclidine, from or there you've if if much. to just gotten experience you're clinicians? might was learned for looking hearing program program? I'm what at I is running either and around the lessons wondering ADP offer key your on what Thanks secondly, then be really that last how that kind then ADP data for or

Tony Coles

I you MX/MX versus through we're I the Okay. science bit up said And times Ray, we're truth is be then piece, always a go the might think that our know the little clarification. engaged lateral with tells additional there the the Because our a us. strategic thesis Jay, the has and that contribution that largely what if it's relative ground some to operating of useful start for but thought you've about effect that would we'd by leaders of is? would PANSS you know But what think with take to in the talk score. well conversation, come great. MX, in it the antipsychotic it's be driven be science conversations. I think couple a I you the that MX first to But with us that thought JR, and you variety what that

John Renger

show specifically with was anomaly, muscarinic's I question. and know, Graig, that psychosis the measurements. they the mentioned the looking that impacts - that an the they on Yeah. the study, impact really both compounds, Sure. to benefits in one know, before were the approach was able in history anomaly after and gone as has non-selective mean, you where Lilly Tony, that's saw at on thanks, for population Graig, and its [ph] the I Alzheimer's as you Thanks, here and the been

like And were in to interested were study with so to you was that study, outbursts, vocalization and though know, able as be paranoia, to we benefited tolerated were complete have a they manner. well that patients things understand that activity. And that dose-dependent in what to hyperdopaminergic related not it do things in particularly that even population, to in

PANSS the more So score. are the a also schizophrenia study also number in benefits showed they symptoms towards related that schizophrenia the in the psychiatric, in population,

to what actually very MX-selective, was to with our a data, first was you what was current seen with compound saw that which what able similar So do the the is compound. were result we

And able that a seeing non-selected effects what that MX-selective that the effects validates MX-selectivity we're that side was compound intolerable do by that void me, so is And - we're confers [indiscernible] what compound. with within to fact also to with was antipsychotic benefit side to a demonstrated caused

is really, treating muscarinic's the the that so increase dopamine are what in we're or benefit And as this levels. about we in talking symptoms of for related looking the schizophrenia related And is to know, to psychosis.

activity where know they're whether target really the that a to by the that we we're at specific the and high levels highly features Australia that expressed But symptoms seen it's for around did are at interest study in or score of in population where was measured the measured in been know, dopamine, we're – that Lilly diseases whether look brain patients. you cognition. is the that today. really system. expressed is Those selectively seem if into the the MX much where the so is more and broadly dopaminergic expressed, related MX expressed in at is can there's on neurons the looking where is provide psychosis MX dopaminergic MX indications more brain been that you that expressed to Alzheimer's and about receptor And be at expressed psychiatric much the controls now drive looking more input earlier [ph] psychotic by it MX talking that PANSS that selectively in symptoms area the have

compound effects think MX study that with can this we've been or compounds question itself that MX our and reported benefit answer seeing for that in side are antipsychotic I commonly an that the antagonize selectivity is avoid with So the muscarinic. that to instance it muscarinic can drive we by other able the

the supports did did from PANSS was from see the believe the in that two was So that different by was selective. of non-selected view was was I better the that's that see think benefit. not what generated an compound anomaly. types able MX-selectivity compound that provide our a confer the score profile. of a we between that that today a we're did GI-related previously different tolerability seeing We is data that data We antipsychotic what dropouts is the But to We the MX-selectivity did see not don't issues. compounds point

sponsors has really, MX in in three different belief benefits is our demonstrated date. different important So by driving the been four is it's really antipsychotic to studies

MX-receptor and believe a have the that that this drives and we can so understand we understand benefit. And the psychosis, circuitry We lot in confidence we the we mechanism. pharmacology network of drive neural that how think

So I'll to turn Ray. it with that, over

Tony Coles

Yeah, Ray. sorry. Ray, I'm

if two back PANSS the we other then If will, you the thinking namely is you could, to to know And physicians and your about I questions we'll be. made, of MX-selectivity time. view distinction I team. prescribing you for might you then And just leaders be might quite actually score leaders about well to standard, was asked. thought talk clinical how both talked they JR that about you will a bit, how bit Graig thought the answer just is that just what operator, bridge little and JR's think a out efficacy come you and appreciate I will Can think the good

So this will our last question. be

Ray Sanchez

Graig, and So Graig points, to somewhere placebo existing XX PANSS adjusted know, as any points. the been about total absolute between XX morning, for XX any psychotic reduction Good has psychotic you average, historically, X Absolutely. on

to how the the the you and very this we PANSS so that many to as and been trials have that a is in point least well in I extrapyramidal benign. effect profile because efficacy on this mechanism of issues a as no wanes this compliance date seeing, therapy, of that of better metabolic impressive can existing Tony's side enlarge selectivity terms trials, in provided that any and forth. robust the think And more you seen at think for and of waxes I that's profile effect, And have or we've introducing look definitely so need terms what a we're a than to in to are if but emraclidine, see there speak effects is that effect time think for these dosing especially response importantly, definitely generated be them, that forth tolerated increases placebo absolute the But the that this population it And obviously, we're as reduction, efficacy and in what as side titration, for a and side we're conduct. depending you But day hoping landscape and have in going therapies over issues, therapy, therapies data the therapies. more the tolerability at antipsychotic not fairly as, recidivism a as - better, good pathway of much that terms need that so in of I once actually is because historically. the will for the patient of need for characteristics and titration multiple variability have

will landscape. data overall, it what and support with but the the not mechanism, the can bring also we're to So confident the benefits extremely only

Tony Coles

thank would Ray. you, clear. very and I think good say just very I was That

with on I probably think of obviously, notion companies about a might companies. what be. won't following And end I I'll what other we practice other would do, make commenting that just we the speculate certainly don't

really but apathy. emraclidine, dementia-related we and epilepsy Our all perspective field we readout And the on ongoing basis, evolves, other really Parkinson's, MDD, things is that shows panic, learn benefits win. data therapeutic we patients, will if focused program success that a of have another but just have that’s as in are there's because the then all darigabat that for on upcoming that tavapadon the exciting in we not the

We to on. so things focus have many

things. abreast of of we So these all stay will

who we responded terms the agency in those explored that learnings companies watched plans. has to dementia As designs obviously, Alzheimer's I we're to potential indication, of psychosis, how other into incorporating learnings and have have think our

and let's appreciate tuned. and the look future for forward time you work today. certainly Operator, keep guys your updates. team thank just hour. informed for you I let's us support, will and So we know excellent to the stay we more. Thank abreast, each you will thank you, for stay assisting your past you We Thank as guys.

Operator

for Thank concludes conference call. This today's you participating.

You disconnect. may now

Cerevel Therapeutics (CERE) 1 Aug 222022 Q2 Earnings call transcript