Cerevel Therapeutics (CERE) 2 Aug 232023 Q2 Earnings call transcript

Company Profile

Participants

Matthew Calistri	Vice President of Investor Relations
Ron Renaud	President and Chief Executive Officer
Raymond Sanchez	Chief Medical Officer
John Renger	Chief Scientific Officer
Susan Altschuller	Interim Chief Financial Officer
Michael DiFiore	Evercore ISI
Mohit Bansal	Wells Fargo
Graig Suvannavejh	Mizuho Securities
Tazeen Ahmad	Bank of America
Paul Matteis	Stifel
Joseph Thome	TD Cowen
Jeff Hung	Morgan Stanley
Michael Yee	Jefferies
Charles Duncan	Cantor Fitzgerald
Douglas Tsao	H.C. Wainwright

Call transcript

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Operator

Good morning and welcome to Cerevel Therapeutics Second Quarter Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, you will have the opportunity to ask questions during the Q&A portion of the call. Please note that this call may be recorded.

I will now hand the call over to Matt Calistri, Vice President of Investor Relations.

Matthew Calistri

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

our of release this press on which XXXX as are morning, to updated our website. quarter from well second available today, as refer our corporate During call performance, our please detailing presentation, our both

views the product file trials. review clinical that and risks related that, the timing and you among you we information the format be reflect specific of remind with development activities our potential to uncertainties. encourage to statements strongly current the our SEC and we of that like regarding would We things, and I benefits our to, candidates making other will and forward-looking attributes product

will Cerevel achievements I CEO outlook. and to hand of over our overview call now Renaud, and Dr. President Ron the to an provide of

Ron Renaud

our you all Good XXXX of thank with company. president morning as call. everyone. you here business and And us today for this the second pleased be exceptional of results new quarter I’m to CEO for joining

about the In seen immense from company. I my far, I’m as team, aim and science have and a at incredibly dedication and time world-class neuroscience innovation passion Cerevel enthusiastic we our build so to

energized organization. drug, into records of the neuroscience track comprised is Cerevel of drug this with my of experience development, smart, in of in neuroscience getting Before with notable observations specifics, let some deep me success. initial and energized deep experience share people

to most neuroscience some with pipeline the the diseases. unparalleled to challenging potential new an have treatments bring We of

loved treatment aware waiting execution, options. ones are new these We are for also focused discipline, that important patients on and

impressed the with company, I portfolio. Before I joined enviable this was

about an the of excited had have and I’m we deep us. with science dive to have into team even of the and details more programs, all ahead opportunity I work the this that Now

programs. to lead our Turning

PAM. franchise build Emraclidine, of this the At Modulator with a pathway to all range address MX-Selective mechanism. Cerevel, we can Positive muscarinic our exploring or a aspects of that Allosteric via are seek MX me Let diseases broad start we as

highly schizophrenia, view for psychosis, has change to disease, in this it believe serious and to treat announced is we and Emraclidine the program half XXXX. illnesses. of other Emraclidine MX expected that and selective out Alzheimer’s now way the morning II We Phase is a we our the second read EMPOWER potential mental

than expected A change enrollment. slower resulting from recent,

the our working of We mitigation on are strategies. am deploying I team to and measures enrollment, Ray with pace restore and personally closely

including confidence details and our updated forward go reasons more provide our will for timing. approach Ray in our

will ensuring plans always, or countries As of thoughtful our data, to we rigorous to focused maintain our standards. are and Emraclidine add we new be quality we on sites the ensure in

agonist of DX/DX program the potential has Tavapadon, as therapy. the disease spectrum Moving development disease. Parkinson’s treatment Phase across believe our registrational for Parkinson’s partial the backbone first the to Tavapadon of treatment now to We the in III tempo establish

L-Dopa as to and monotherapy to disease ideal both the newly for has preferred serve diagnosed the adjunctive patients opportunity Tavapadon progresses. the as therapy the

TEMPO-X our and of data of data expect will We TEMPO-X while readout out half XXXX. the to first XXXX, be second in from read TEMPO-X

both our epilepsy development PAM Alpha in GABA. Darigabat, currently selective to X/X/X now Turning panic A for and disorder.

control medical address need need better trial for of Phase seizures. is their to patients designed who realized tremendous an epilepsy Our of area II focal and unmet

be to readout coming our program this next of expect We year, XXXX. data mid-year second

panic proof-of-concept of trial We also a disorder. in Darigabat, initiated II the recently Phase ADAPT trial

believe The of benzodiazepines. effects main subunit, for Darigabat We and receptor the potential side have confidence in we is profile treat related avoidance Alpha receptor disorders anxiety to given selective driver subtype of the its X. of its

late anticipated readouts is expected we the front, next that have strong year. a On of balance our support data sheet stage financial all to

Susan it the Financial welcome Cerevel Ray, newest Team; I members Officer. to Before Dr. Chief Officer; to hand the and to Executive I want moment a Chief Development Strategic Operations Altschuller, to take Business Burgess, and over Paul

management, development, senior brings experience Cerevel, from brings key deep financial planning important companies. investor juncture during and leadership and warmly biopharma relations, development, experience seasoned team. in welcomed been business leading us of Paul this skills by business Susan three all operations for corporate Cerevel’s have leader’s

by together all I’m a proud weeks have team. I’m company products. we just with our executive will multiple all world-class seven build in together, colleagues Cerevel invigorated along of do as neuroscience with commercial that come of how we to a new energized

I to provide to that, about Sanchez, our Ray. our turn over Chief will the call programs. some added color Officer, Ray Dr. With now Medical lead

Raymond Sanchez

you, Ron, and morning everyone. good Thank

Emraclidine, with trial Phase plan this highly as will clinical developing I our Modulator results healthy Positive disease we this guide start elderly currently we which schizophrenia or MX our and development ADP. PAM, me Allosteric Alzheimer’s trial Let or our both in indication. selective In psychosis, advance is important the of ongoing are in and ADP, volunteer

schizophrenia EMPOWER and II Phase to Turning our program.

trials experiencing As three of XXX two acute adequately that an a arm EMPOWER-X are adults exacerbation include psychotic symptoms. living EMPOWER-X reminder, with each powered and schizophrenia and

to a milligrams is the The FDA once daily versus designed as trials and and based We package. these XX potentially meet trial on the Emraclidine what XX milligrams to second first registrational versus necessary in is criteria trial pivotal we studying milligrams serve XX placebo. milligrams the will evaluate daily and placebo, trials XX once expect

Emraclidine registrational extension in XX of EMPOWER-X, our package schizophrenia. to We trial, studies and also non-clinical prioritizing are safety week and for a clinical pharmacology completion the label and open enrolling accelerate potential

momentum discussed, taking pace outset, XUS enrollment. observed of slowing yielding this slower U.S. and in recent Ron a sites strong Enrollment in at in we that up but had enrollment. than several program the As with months stand initial have longer slowdown some we to planned seen recent a have sites

sites. responding are to existing site and in measures, plans investigator and enrollment with accordingly We mitigation increased including outreach enhance

add a total per look beyond going sites countries quality XX quality and to U.S. two data placebo response preserve to risk. of also the will the more additional one trial in without sites mitigate to high We and

the focused deliberate We recognize laser patients trials and prior pace these quality importance executing while Emraclidine to data. maintaining We to speed and of to we we on the acting are and to address the will with seek stay our investors restore the central potential serve, of our Cerevel, continue enrollment. of these headwinds

within of revised to With the efforts the these strong ability I’m in our confident team, highly timelines. deliver

are XX% known with trials rollover high encouraged the Turning we Phase which DX/DX Tavapadon, partial by now extension ongoing, more. open-label a TEMPO as agonist are along trials are in collectively to the III our or rate of corresponding

data data second in coming readout data half with be for first to TEMPO-X and We our XXXX. XXXX for TEMPO-X of TEMPO-X expect in the

currently will comparable available GABA. believe but in for I with panic endogenous to now disorder. PAM, We reduced benzodiazepines, which both development A selective has Darigabat, is epilepsy and side currently and the effects. activity potential Darigabat discuss our anti-epileptic for

action novel mechanism option expected treatment Darigabat’s used that a be profile tolerability provides of and chronically. the may for potential new

and realized is in epilepsy expect focal II progressing results we and mid-year Phase Our XXXX.

a into Here, we by high open-label realized the also are encouraged rollover rate extension. continued

The of enroll daily Phase Darigabat the II about potential trial panic ADAPT evaluate patients are and twice disorder. we with trial initiation versus milligrams the through of excited XX ADAPT a will Darigabat the disorder. placebo epilepsy, XXX expanding trial, applications in Beyond panic

panic period. during weeks proportion of the Symptom of Scale in panic endpoints will panic frequency in key in maintenance disorder change subjects, Disorder the or of the during last from PDSS baseline Panic free be who last not the the The XX in primary attack total of maintenance change the weeks two the and will attacks secondary two Mu And be endpoint at has A the week score drug XX-years. from approved nearly baseline been period. are

need new the to therapies. patients about providing in excited are of of we So Darigabat potential

let stage that, an on me John turn Renger, to Scientific Chief to our John. Officer, Dr. portfolio. With early it update our over provide

John Renger

everyone. morning, have Thank that clinical you, the research development. in pleased with progress made Ray, we I’m early very and and discovery good

were Let’s considered CVL-XXX. ascending our begin recently and trials also with completed and tolerated. kappa range We of doses antagonist, program a single administered or our both which as receptor well known in multiple broad dose opioid KORA

will the the provide range and interrogate target preferentially enable at receptor wide receptor both the range Mu provide for Kappa of that Kappa increasing by and a selection trials with Kappa either of doses Mu These will the of opioid a ore dual simply both dose or This can us activity us potential receptors to occupancies receptors. native exposures.

major enable a interest, We tolerability to anticipate that explore post use which populations disorder, dose traumatic of us depressive efficacy flexibility disorder. this and stress substance understand will include number better and of disorder, across

pharmacokinetics administration to results important dose Our to is regard meals. demonstrate without ability the and to-date for date

consistent are we in addition, antagonist. serum have change demonstrated In predictive dose that a with opioid related biomarkers

occupancy Institutes our of initiated National we are clinical support over both characterize of grant the the pleased that to that, internal Abuse also our steps to determination announce recently $X.X I received to NIDA tracer I will additional of exposures. million development We and to or CVL-XXX, Mu future. across receptor trial receptor including PET three-years plans Drug ongoing for Phase include further PET updates funding selectivity in and displacement anticipate Kappa next We Phase for providing of compound data in

the our our at in or program, from Foundation is Parkinson’s the for aimed early internally news grant research disease. we TMM-XXX to exciting J. of other initiated progression to and received Michael advance pipeline, a Moving Parkinson’s stopping Fox stage which recently slowing

its protein XXX is a has which identified our unique channel. idiopathic is and be target particular Parkinson’s interest and This transmembrane As protein, because to disease. of proton an recently context, relationship or believed of potassium endolysosomal TMM-XXX to structurally to team genetic strong been

intended disease consists It the develop Cerevel program of disease. that solely compounds scientists. debilitating chemist TMM-XXX been therapies of potentially by initial neurodegenerative Our of one stop to our modifying efforts and discovered identified internally progression our represents to have

the chemical progress efforts be continue as finding will program. in to effort research We look forward science program’s We advance Fox details to Michael compelling and the this more made Foundation. look with enable matter. behind we to support promising new This working forward sharing in this closely our J. grant to

Officer, financial going that, Altschuller, Susan. now of performance who it the review Chief to Dr. is With second Cerevel’s turn I’m Susan our to to quarter. going over Financial

Susan Altschuller

you, Thank John.

quarter development of expenses second of administrative general operating were million research expenses, XX XXXX, of million, of XX and and the expenses. and $XX For approximately million comprised

balance maximize into to sheet, securities the runway we of priority provides strength in We to ensure ended $XXX for the Opportunistically which a us company and our second sheet balance pipeline. financial comfortably remains the with XXXX. value bolstering the marketable maintain quarter the the million roughly on cash broad

how our consider our for creation record collaborations patients a track access and variety we thoughtful in and about options meaningful our partnerships capital, and including of shows, value will As regional evaluating be we of we will service shareholders.

back will call that, With for his over concluding hand I Ron the to remarks.

Ron Renaud

we have neuroscience. believe we Cerevel, an unparalleled Thanks pipeline At Susan. in

thinking are as start that as tenure We I this potential big, can is inspiring. CEO, you company tell the my and I of

of to and be disorder. of We of honored be to new treatment epilepsy, neuroscience this some Alzheimer’s at are doing the schizophrenia, and pleased company committed to including options incredible patients helm work bringing devastating conditions, most together here. the disease panic psychosis, important we Parkinson’s disease, and the facing part I’m to are

look under have the and hood have close focused assure operations, at our can gone I I I and we on are execution. taken you a

quickly team entire promises on patients new as to executive possible. is deliver as medicines to working Our together to bring

and first followed EMPOWER half remaining realized and look in a With forward portfolio. expected readouts. Darigabat second robust updating advance data half I TEMPO-X, of we this data you busy the by Tavapadon TEMPO of with XXXX XXXX, mid-year the as to our

With with like and trials and our who employees open graciously to would investigators in let’s we my the make I possible. call sincere that, our clinical do everything for to questions. patients thanks conclude the to

Operator

now [Operator this I Ron the over like time, back remarks. Instructions] for Renaud closing turn conference At would to to

Ron Renaud

I think Operator, double so see in be folks there here, on should could please? check, some you queue. the I them

Operator

Our from of line first from question ISI. Umer Evercore comes the Raffat

Michael DiFiore

Thanks on Hi, this Michael welcome is Ron. DiFiore Umer. for much and so for the question

just A better want working I schizophrenia understand delays. the the with you. to drivers Looking very for few me, forward trial of to

the you is a with maybe of outside and And COVID? what do causing as that in that seems What in general you. delayed, coming that be to Second, in Ron, it are is the what psychosis studies. using? more an Thank is to outsider different if there conduct is can, of you of schizophrenia CRO you just reasons something or them be experience, wealth think

Ron Renaud

Yep.

So thanks for the questions.

be provide a the will We some Ray know of we logistical to in You this will know, the But let patients. of the I prepared on this truly for our for potential basically, say again. some said Emraclidine. We remarks, color transformative it know issues. importance we therapy

towards are quickly you But we bring incredibly we to this continue the hear as do in compromise that talk are as but terms And variability rigorous I an to that can of site with at a role about to can other moving this, ahead think minimizing we play our in our comments eye placebo effect. possible, that and things in of factors are selection be while this we some on not going all. to in going Ray

at would To we how a a these your I at undeniably, fresh here, new of delays are here, in our fresh a some Tavapadon, forecasting point, as we are better now here and you Susan everything putting can think, Emraclidine. job reported how and we yes, is set new new, taking timelines. on tell Paul we have is other with eyes the look what do enrollment we everything, do programs, And I past of I’m Darigabat, is

this in a committed We and to And some And tell I respective the the job of, indications. things that we this we at know you better and right at need given Tavapadon importance can are this getting of do what that critical now. Emraclidine, are these is of to right. is do looking are their we Darigabat

With the some the CRO, issues let I to take the will driving factors specific delay regard around and Ray that. of

Raymond Sanchez

Ron. morning, And you, Thank good Mike.

because extremely all So is its you class, what program to once new I no need principal continue tell dosing excited talk Mike, in specifically daily and about Emraclidine I that of and the investigators Emraclidine titration. for this can are to that, the

a is excitement of So there lot there.

We site of these root cause the at continuing level. are delays understand to some of the

are on data Importantly mitigate not response. to because we strive to integrity, to going use data compromise trying manage we quality, the sites, placebo best and

rely patients. to have right we is on they to of that understand key And ensure sites each you that thing, getting get also the patients. that But referrals the right the the

the than doing that bottlenecks others the months some into are getting some that right better trial. those in so, the so, of And are really hold but patients collectively

response, which are again, right, ensure of the them getting the But earlier the on, as in just for are we making greatest because exacerbate sure heightening are that plan these with placebo I that laser don’t our so we said investigators, this the likelihood success to we we closely, focused, we call focused, communication so with work trials.

focus. that of experiencing. against main challenges up we in and our And are, really is the some terms that sites um, they So those of are the what are

Operator

Fargo. Our next question goes on the line of Mohit Bansal from Wells

Mohit Bansal

Thank and to you welcome Susan taking my you much with for and very forward looking working Ron, Paul with. question

one question same limited I the you far, when the reasons. timelines, so because, mean mean have my could line So in so the is at spent I look company Ron, there also two the with be or time you

is it changing like, especially that one because, aggressive I it enroll where, Like, there obviously, cytopenia hard patients. - probably trial, is now these around is providing these something this and case the is is trial. a other I investors was look, in this fair, a a realizing short little fundamentally this of, not or to it looks mean, bit the to I’m way marketplace, asking is the mean, timelines where

enrolled. So can it still fully say - away still that, point is we trial the is the are we where from ways

is? the So like, exactly just is, what it cause understand is trying underlying to if

are second in so package doing out terms part is the the that that, filling data then some And the trial. filing you of of work schizophrenia right question for mentioned my for you more

been asked that. is it So

generate in need how about and think filing schizophrenia timelines to of So you. how there? Thank should data much terms we the you for timelines

Ron Renaud

Yes.

So words. thanks the for good

and back us to hear over this this again, I will you again. will all, of over and say keep coming First

ensuring of Our the focus data, going site are remains be on and selection. quality in our we to rigorous

we are to rigorous focus that reduction work and going be We our investigators strategies. in variability on with placebo the

increase, number that seen we what that You industry on of are that have And number as something really patients focused the as in the increase, sites the of variability is minimizing. increases. happens

the in we form, that are with. just quality or not on sites of we work to so And the shape any going compromise way,

there to out. at to a timeline. is to I natural there the sponsor speed And is up, always unfortunate to a we it that, up and hurry is want to know inclination going push the meet want natural be things - this

on not we On to hand, to are of sites we again, the to here the the using that. going are and we other focused compromise so stay going continue quality that are

in I have the in second being And said, file anything want so we for out with half, to towards, place reading pieces of all are be point NDA the all of the to with putting That pieces to that the exactly here. Emraclidine data we putting an place, agency. we when prepared file in don’t been would and

that program. so are all the we with happening down time that pathway And at each execution are is on focused And we same this other. working of in conjunction that

Operator

Our from Mizuho next Suvannavejh of Securities. Graig the question comes line from

Graig Suvannavejh

my congrats forward Susan I and for new two my you. on look if taking work you may. Paul, question. and Ron, the questions, And I I have and with partnering with Thank positions to

any just a are the overall thoughts. bigger a just review on, as need do step-in Ron, Maybe changes? in of to new months strategy, thoughts a First, of you like, question business need bigger picture view CEO. picture that, whether as X with Any and you just you coming you before kind broad making on,

in order Phase [Sinovion place high second regards risk readout to (Ph) of TierX] just the measures my is Emraclidine it program potentially the you’ll best best question, in minimize to negative then the a ensure us, I wanted that large see with minimize to where for and was we Ray, light to Otsuka the the to that trial placebo a ask III and you in remind maybe this just putting you negative And trials, that order for outcome? Thanks. very a Could in ascribed response. chance response placebo are of

Ron Renaud

thanks of for question, will, you the that, take and asked as so Yes, part. the let Ray first to take part I and then the will I second

are we possibly or perspective, absolutely, eight make I this. an efficiently over coming and are as seven in, many sure So, effectively as and as weeks we into we turn from operational stones can. Obviously, to as want working

There on here. going is a lot

than XXXX have more right We on studies Cerevel’s now. patients

of part number are number mention We studies, that registrational studies of are pathways. double-digit the to not those of

And Cerevel company, our here initial views very so, are our fundamentals you at is my I on that tell everything will strong.

we I pipeline of assets. believe have unparalleled neuroscience an

you be to think as would of robust neuroscience another assets I broad and that as industry think - here find in would struggle as I what have we you looks Cerevel. in portfolio the

But we that clinical on to can got execution of clinical much the forecast trials, we have focus enrollment making continue effectively. more these of these trials in sure progress the to these timelines

folks the out. we Obviously, that we the us, helpful what helps of our roll we us these for it they community, that about doing. are important think investment we try know in in planning to is for programs all But how out figure also as as it is

And are looking so, we at that.

those. We are next continue want year. pivotal to to sure trial on of I of prioritize multiple well for we readouts very the trials make we execute and these all progress And preparing

Raymond Sanchez

a that quite moments how Greg, the thanks to have you for underscored and the I we mitigate ago the we field. was placebo are data doubt few sobering, to response. just trying that no And the think, outlined, question, as

we doing critical. you are and the mentioned and right really ensuring we that we have that is how is what before, what So do patients get

looks a have do so, And qualification. the in really to we that at place patient process

to not the patients, raters and to actually just but to of of we you we a are the about When access does address outcome the as in know talking Because know, the site. raters others the say competent place right the profile and we their have that at sites, quality ability that. have the quality drives ability so, robust these patient trials, really as plan really

made of is much kept ensure number to of at made we not number doing each as that Other placebo to that bay also at be the have sites possible, things limiting the are and certain sites or interventions countries. that for as mitigation is a the placebo of response we allows limiting protocol but be the

are do you see enrollment. waxing you that, And weighing invariably going to the when of and

data at the and success. greatest point However, the for do you likelihood you position trial no dilute your of

confidence we success that that of So positioned collectively, have, greatest the likelihood for and trials that is these are the outcome.

Operator

comes to the next from Bank America. of Tazeen line question Our of Ahmad

Tazeen Ahmad

look might and market you. that a can forward what have And how little for schizophrenia? ultimately or looks is? find several that on large, you call need remind the with be Ron is to your I there color of to in what might maybe cash right us a which that schizophrenia you for on wanted subset be give into population, are be mentioned drug? times Can broader just congrats would the team translate that right new then you your program. bit could now secondly, and Would the population we you you still a like working the runway the on it be opportunity just clarify, and quite Thanks. patient to patients best us the think suited roles, you for thinking of the what

Ron Renaud

your over turn question on part of second the will the Susan to and part. Ray I first So,

Raymond Sanchez

Thank you for that question.

for this the patient, are So, to we so remember talk trials trying are schizophrenia trials, meant When we therapy generalized the the we has. clinical about population. the right conducting are signals detect

do the of to to in disease. need the you that, severity And order so terms population in patient of refine

going really So, score the population. and miraculously detect best to to opportunity as be you XX of signal therapeutic of in those variety least the a that is other robust the up give a patient the it define the criteria, XXX. of population really PAN you And know, to to we CRI is have to at a

But have for to experiment, patients of way It you in it to the to in conducting that you have certain because clinical population. certain in the likelihood population works are ensure place schizophrenia controls not mean any success. However, the and greatest you restricting really that suggest a is are only general doesn’t others. it

Susan Altschuller

ended well with quarter balance are sheet. we and the on noted, second the As capitalized XXX million

us our funds read next into XXXX. comfortably key So through that data year all outs and

we and balance we position. opportunistic So about thoughtful about feel be good sheet, bolstering will to and resource cash but continue the very allocation our

Operator

of Stifel. goes Matteis question from line the next through Paul Our

Paul Matteis

Emraclidine, a we are know typical the noticed could put elucidate study just that an or drug? a Is to that to for interaction check interaction clinical how drug On was trials.gov. it actually you on relates prescribe the you expecting an box study that NDA, be significant as people

And studies you a the I do pipeline seems in an questions has plan program. on couple in I was depression? perspective with suggesting Kappa have external had antidepressant curious this and then a more agree now we guess, you do target that separately, that moving your I couple effect, quickly now on like it

the as And a well. point that was targeting do John, MU I MU dose your that effects. we side it under then, to on produced to want range relates Kappa and be more as impression to

could kind so behind of you maybe compound your hypothesis scientific and thanks it. speak much. you thinking how So just about are to the

Ron Renaud

like all John sounds these. take can It of

John Renger

to You Thanks plethora appreciate try here. questions the Paul. don’t want Ron? of I

package. DDI standard the for is yes, profiling registrational So,

can so for as dose patient And to you know, kind the label adjustments right each and their make decision potential inform for therapies. background on based DDI you a so the physician any on the of have

And so much standard. are pretty these

excited. really are we KORA, For

company second the has mentioned, you as shown. now So

action company, as care recently an for a Major a that, of nice know monotherapy company in standard benefit also have potential colleague core adjunct is monotherapy. nice you showing Depressive The a MDD. mechanism first MDD showed looking as at a I and seen of the a say, the the on effective will colleague we another showed in now Disorder, So the

So action, we been with published think in consistent quite the preclinical mechanism models. of is this extensively very what has

you for actually there know, go potential MDD. a mechanism is this beyond lot of As to

received, mentioned, the is funding NIDA, have receptor with morning, even fourth so this the being go, closely answer And you an in I clinic, into know, like more as them. is, we PET that to been lead one going the next of which additional there studies one, to occupancy to working we

that think And what about to it so, when achieve. is you you want

both selective what look competitor kind have more to the very highly is we a at recent Kappa. the have that we approach as you non-selective that the if So of the consider molecules, data adjunct you to one and seen first one seen with be is

nice both highly so have either selective a a you activity And or that is a demonstration mixed in activity cases, effective.

as you potential could the of some different actually However, activity. new think may across what those from some be, having benefit indications

And to look and take this for to do we be about think able how want dose so, what molecule different we is indications. actually particular that at ranges are appropriate

do disorder price unpleasant extremely as you new if an example, opioid for is in to the went use you want patient. on into so And definitely a study you This substance patients, not order withdrawal. have activity because could induce

dose be would some and activity. actually potentially would indication, new a benefit another from where different that range so having And you

based the to fashion, for are and with gives the would very can about each what a think wall molecule we cover potential a us I we this broad it on that disease group. of etiology indications dose know different range actually So at in ranges tolerated appropriate benefit look knowing that what a

exciting so, And is molecule, a it really exciting science. really

so And and stay more tuned, share can. as we will we

Operator

question of line Our Cowen. from from Joseph Thome next TD comes the

Joseph Thome

committing I results in and thinking ADP, the you are do level I step? EMPOWER before ADP, to next advancement to Maybe healthy tied how what for would the guess, read EMPOWER the you and, out one, Emraclidine are the to advance in we next about guess, the wait study to for that want looking volunteer first to as be studies

Can bit you symptoms about baseline panic we then maintenance an at think then I study. Durigabat on just patients pretreatment And the of a guess, titration and medications and use just in disorder on Thank terms maybe are a do patient can baseline when how you. severity rescue they quick the period, have one or, attack? severe, little through comment if any

Ron Renaud

and to will Ray. over I turn that So John

John Renger

Sure.

address can ADP second speak then So the I the will will I questions to Ray first and set.

the as ADP So population age. population, primarily is, from know, the by differentiated for you schizophrenia

elderly is then what so to do you what have a study to and is And patient TK population. healthy into want the go we then do would

looking previously so So the we CNS what drug are we we have want the we that we achieve be able occupancies for, what to will NADP of occupancy can that we the are patients. to that receptor confident MX to data is will achieve test exposures demonstrate that of mechanism receptor related PET that

at the to looking forward are into for we ultimate what so, tolerability take is the to safety that patient achieve want and And population. exposures we

so, what sending we multiple middle you the a as dose were to that. know do is study And in of

will data path help a demonstrate then forward. that so that us we And have

what we is well are demonstrated that have previously. kind looking really the same so, that of we tolerated just we profile see And for have to

As than it different population. schizophrenia the very a population is

make So inform to at on the this point. is other any conclusions difficult, it I think, whether about one would

Obviously, and we there to and are that decision indication it as rationale are in is so anything our be will that question as can to need waiting answer, for is this effective both, gate not we but progress others. we or in potentially believe going to the else we quickly to

It is it is and as think fast of we we I and safely go as type not see approach. can so, as can. a And wait

Ron Renaud

Joseph. Thank morning, Good you, John.

approved the Nearly really panic are that much needed the for to with that. we ago disorder. is in was landscape listen, new a So potential the medication excited last which about therapy, XX-years or up come

panic So of that with panic at or a using have are, to so also greater, least population the and free panic moderate month of at severity attacks week symptoms They XX looking attacks disorder we scales prior visit. no the have screening of the are threshold XX in being population disease. the eight the is moderate to we

least baseline in the to two visit, weeks And the leading have panic attacks. at four

And something appreciate drive studies. a that question. lot so, severity is does that does and the outcome Severity in drive these of so that

likelihood population ensure So we are using the the right of greater success. to

could medication potentially allowed as confound trial rescue the No in is that the outcome.

they allowed. also not screens other not So visit rescue every are rescue. we medication therapies that make to doing sure is And as are at using

censored appropriately. or be those So patients discontinued would

to trial what the success, that the to with how we right of achieve. terms is ensure and in methodology greatest all trying are design you the So, likelihood do of

Operator

line of goes Our next Stanley. Morgan question to Jeff Hung from the

Jeff Hung

Ron, roles. for Two the new and to Susan questions Congrats Paul on me.

about the appropriate of the in what market apathy, of the for opportunity latest on the size challenges is for related can patient identifying talk your identifying you appropriate First, and thinking challenges context dementia patients, population this indication? for the

panic what to And enrollment how’s proof-of-concept see the and for going to us Thanks. consider ADAPT study can disorder, you the then you second, remind of need success? and the

Ron Renaud

or Ray. John Again,

John Renger

will was apathy Fast Jeff the will with very new designation is them. that so carving are start so, working that We thank related dementia Yes, closely the receive I we FDA to forward. path this do be - we so Track order a you with in from with

conducting But that truly trial that the is we it experiment experimental. is are an

at We primary scales, hypothesis various no per are looking is not se. formal forth endpoints in there testing of so terms and that but

the caregivers, apathy so recognizing One practitioners, families, of the the really is. really, challenges the patients are, what is, course, the these of understanding who landscape,

criteria So closely Group, we the FDA these in involved the which identify working patients. very been order to been has to understand with with have ISCPM

dementia So, disease the syndrome from patients biggest identify really that the challenge leading there is a neuropsychiatric half of with patients is is that apathy. suffer the It out the and know progression. of predictor we to because

that also sites identify the we focused laser on and helping right are So the patients. stay trial continuing to

powered active during terms patients of the know, the trial of of attacks proportion XX% a the last panic difference so of with as XX-week between of in is In you to phase. XX-week weeks phase. in two proportion free maintenance of disorder and panic maintenance are the it is a the meaning placebo who trial, really detect a It patients, XX%

endpoint? that to has patients has been takes you therapy as why understand that endpoint. to time and is that that the like And that endpoint been, Because that it historically wanted the the know, FDA respond appropriate has seems so an for to precedent said and

trial, continuing about at the know, within and last you are that initiated are those few as So we weeks. it excited parameters so the just

point are moving about progression but So we and at we forward. of any timelines the excited not we have this provided the will, program

tuned program continues. And so stay the as

Operator

the line next Jefferies. goes from of Yee on Our question Michael

Michael Yee

clarification color. enrollment for we around ask schizophrenia, around Following-up to on the wanted questions and the

listed of sites you there. up go to lot have know, You ct.gov the a got up you

and and what I issues a think we the the lot it, see competitor as just on it but some coming I just have center that. of so patients shed that a really is wanted is the overlap got to not the just some of the is what actual little sites at because sites, in up, them of some like really to light trying of we are enrollment of bit major don’t about happy we centers logistical and getting centers think are Hey, understand, or are. that we with criteria we Maybe are the

studies an to but are that is after to NDA. NDA related know data around I set. I and is you six that standard studies the of that then typically other the to non-clinical months that months, the competitor related many are running And know it a file completion taking

So second do if data that XXXX, should comes studies half filing first a that non-clinical you XXXX? have in the all the feel out timing half comfortable in based of on your and the of that of timelines all

Ron Renaud

Yes, Ray.

Raymond Sanchez

So morning. Michael, good

as as seeking as course the everyone they always you best well. of are potentially are know, and are we else So sites

going are be overlapping with sponsors. sites there some other So to

site is to independent so, That help really looking we at exclusively. patients the your by getting right To that patient of is end, a it the have really method proposing around, the actual achieve site, that. which and point, the we

over criteria bottleneck. that have a waxes time, patient to accessibility the sure wanes and And the really we we trial. the make that bit committee another that sometimes So patients and is it independent at of have can looks be the right in

continue to closer initially. of of understand just sites very them root But what’s an certain the with really, of up exciting measure with the cases. working bulbous patients, started of are a ahead you that causes We holding enrollment we type schedule in and to to that, remind

we U.S. the the slowing this In down, few in seen last have months,

historically we of we where XUS know course, site, choose and for countries Secondly, sites we have that had well. the data good

down getting those volume with. at and issue that There the has those at bottleneck just there a countries they slowing really, level IRB and the a country is at the think also I do really is of are approved, protocols it grappling level, been

up have and running. the But all we that need sites currently we

potentially new on way, not the exacerbating response. are and again, looking data in focused always at quality, We new not future in sites countries and diluting data any placebo the

get that we to data know need sooner what therapy are very achieve So we also want we to out to the order to well. but and do than we in trying is that, robust this later, patients as

John Renger

will I second Mike, question. And, to speak the

reference submission. in for So to our preparedness

of the have are, the the obviously, So clean all data, also on dosing we studies the data NDA things. the the timelines over that, of all all for module and preclinical required sure to and farm to inform CMC make we and those CMC types

I’m will, And will have how get - going so in time definitely much the the definitely is, to it hand but to data we readouts. we not position to we commit when

And the NDA sure so doing necessary readout quickly data work on that get possible. and from timeline make are we completed all very minimizing that to the focused we as are to we submission

Michael Yee

the It you. Phase besides can’t that be Thank is of part pretty think data. III I the package important underemphasized.

Operator

Cantor from the Our Duncan next comes Charles of Fitzgerald. line question from

Charles Duncan

And also Darigabat. wondering Emraclidine the study where Emraclidine, I any I any sites you color interest. have over rate, you had on then patients direct any regard open that that a EMPOWER-X, in to and guess, and feedback to investigator to then agonist. that have With have enrollment you on do to regard the overlap you question rolled in in if then actually with share a dropouts label? provide can see over on and addition with to from I’m

Ron Renaud

will Ray take Charles. the Thanks let for I questions those.

Raymond Sanchez

week That they six program course, over. patients they file set NDA. weeks for data So Charles, extension when complete way to exposure to yes, long-term and have up we of that open-label do opportunity us the to when XX we roll and the gather over the exposure have patients into need the the the is continue that data, trials is that rolling that we

is In that really and the giving for of excited for by alternative really class, as mentioned things symptoms. that Emraclidine, the their have to that a patients psychotic community of one been and earlier in level by but call, terms better really Emraclidine, comforted this new the of investigators, the I treat specifically has enthusiasm I investigator the

been we to ensure closely get again, we mentoring have with the as we them morning. mentioning the are working So, through right patients

would else anything answers know to so, And I about you that hope want your Is question. there that?

Charles Duncan

color that have the your think you appreciate and enrollment. I on efforts all No, for that is clear, provided

you to high guess perhaps I about on mentioned that intrigued label an Darigabat, Just the to moving patient me therapeutic the open enthusiasm that rate about that epilepsy in quickly quite wondering the the I’m profile. I’m reflects in with rollover extension.

if wondering I color provide So guess any I’m further that. could you on

Ron Renaud

to Yes, of so rolling predict rollover it difficult is in rate terms patients the always over.

a So we quite when patient therapy to they come potential seizure up therapy the as of eager, or suppressed that population. are really activity. excited in And to we you the with see about get rollovers, try seeing, are that robust as are we

it excited we are about and rate, the we to monitoring be So, closely. rollover continue

we will time after we - getting our phase the program. over are We that do exposures Phase need III when ultimately in file

all that. to speaks of it So

Charles Duncan

speak well well. label the as to rate as as rollover within Differentiated the persistence tolerability. open Might tolerability

Ron Renaud

data, good this tolerability time to for point, that for conjecture, of in we period may like, of it rolls because I look it if terms puts just It will data think the have But would in wait out. therapy then to at a we light. what long read should and be your look stays somebody obviously but a the obviously over at on

Operator

from H.C. of next question comes Our the Wainwright. from Tsao line Douglas

Douglas Tsao

what to to logistical any or of are joining for Ray, the curious the I’m start terms but everybody criteria taking Maybe we exclusion obviously finding there right not with in sort things logistical the But perhaps beat bit might issues? to process team. a you to those additional of provide? patients, I a slowing have get horse, any dead little are patient Emraclidine, inclusion Congrats benefits mean, any patients. are the just the down that screening and right

Raymond Sanchez

and momentum with the great slowing that is the hasn’t Remember we few that So, seen to down that, have changed months. process process. in Douglas, started there last what the we from nothing is

sure safety place trial. to that we true stay success earlier, the of the patients, We that, a to net it get make I as drive of kind have the mentioned make very to sure robust ultimately right that form, investigators the

down. not So the slowing trial that is

wrong patients I positioning And parameters the got these ensuring have think we really to finding and it right really no the around that and we that are and on It likelihood that. get that stay to again, based and is we wanes very trials But success have greatest around with the those waxes time of steadfast and over to we and quest. time. is what stay patients. focused that committed doing at is

Douglas Tsao

sort just just runway? studies And then just was of as you affect now of cash moving parts and that think assets about your some later originally as later stage does some a planned, moving stage are how you obviously some given the follow-up, development pipeline, out than reading managing earlier of the the think about with into

Ron Renaud

but to the about many really of early today, are And we will to that. sure what programs. be continue support can to balance need our the stage to to close one. I do these make know, spent Susan that attention we interesting take that balance mentioned, late conscious You only going that are important sheet stage of and do programs we to we pay talking that not we opportunistic as most Look, of and sheet, very time

And so, stage that the early program as won’t shortchange we well.

something equally we right. get program And important is sure so is that as as late this the stage making

Operator

conference back At you. Ron the to this like to turn for Thank closing remarks. not I Renaud time, would over

Ron Renaud

is also to all, Paul the excited first know want welcomes. super and neuroscience that that questions here, I’m Susan most world-class thank the exciting be pipelines to It of to excited I part morning, incredibly be of for I for be neuroscience are but something this the and one to really warm everybody building this part company. and I about. of of in So

XXXX. funded to doing well work the are resources we all well are into We maintain, with the

way. you lots things and looking as fresh with along more of will eyes months things of are over have at set and many all the We to we we are of a coming with learning discussions the the

right what registrational on here. going there here foreseeable not programs but of that, I these with for going busy the then future incredibly But XX-months, underway a two late are work programs going to us is important is number that only at the behind And a Cerevel. that two NDA And significant to balance, after stage on think NDAs of incredibly find you that. for next lot programs, is keep XX to is exciting.

of I we more move ahead. you everyone great So having discussions day. programs look forward Thanks all on to these as a of all hope has a with lot, and

Operator

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

may now You disconnect.

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