Earnings call transcript Q4 2022

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Operator

Good morning ladies and gentlemen and welcome to Cerevel Therapeutics Fourth Quarter and Full Year 2022 Financial Results Conference Call. [Operator Instructions] Please note that this call may be recorded.

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

Matt Calistri

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

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

Coles, to I will our outlook. now Tony overview an to achievements hand CEO over and of the Dr. Cerevel provide of Chairperson call and

Anthony Coles

and become you premier was good Darigabat, XXXX remain neuroscience. important results XXXX extend that year a results to thank quarter successful achievements as We to the and to everyone an and Cerevel new on and year our and started us positive XXXX runway at continue in is raised blood in data positive we business cash we organization. anxiety into great steadfast delivered in joining of have capital momentum Matt our and mission our towards aspires December, pressure our Thanks million full in for with the company morning year $XXX marking transform neuroscience to possible distinction. what set for Emraclidine in for call. and trial fourth the achieving particularly productive focused mid-year

specifically or modulator first PAM. MX-selective our highlight me Let Emraclidine, positive allosteric

priority. top of this the our program We which remains pleased momentum with are especially

readout Phase adults and more that living with is schizophrenia robust of in enrolling first on in caregivers the patient at the EMPOWER in XXXX. area patients know experience U.S. Our this communities and the large II half million program data for the of remains well more touches a death need lives the schizophrenia for homelessness, track than tremendous, disease We and likely by is with live and X addiction suicide. people to with

other transformative as We prioritize continue important in necessary activities, to quickly the patients Phase an extension program order including medicine possible. the to completion as II potentially this this bring and open-label trial of registration-enabling to

last step this blood Phase and initiated of development. blood living elderly We took not conducting positive evidence also differentiated which psychosis affects indication we that the of important chronic are people delusions pressure in in FDA Alzheimer's early schizophrenia. were were support proactively with I Alzheimer's to living and an Alzheimer's We disease in the associated and of with sustained we Emraclidine concluding development The the fast-track that strong toward year. treatment for in receive trial dosing a hallucinations trial disease. monitoring at Emraclidine December clear Driven this Emraclidine important condition for clinical to info increase with selective a risk-mitigating ambulatory trial provided and a than from more registration exploring announced in of by results the advantages treatment for disease designation mechanism, also targeted, a XX% by from our XXXX, psychosis, volunteer induce does with of the pressure people healthy pleased end our belief

novel conditions part ADP, also and neurological which pipeline, pathways by story. advancing therapies other is only Cerevel. we is schizophrenia thesis central underlying of with however, Cerevel one for unifying in are broad serious the approaches Emraclidine the Across selective targeting with work new Our our

of highlight and I'd receptor proof-of-concept to now selective Darigabat, conducting trial GABA development in epilepsy. PAM such, A Phase trial, like in panic alpha-X/X/X epilepsy focal the disorder. II REALIZE both our a As We're currently

the of every out Epilepsy common fourth people. disorder, neurological affecting most is X XX

to Our patients an REALIZE need Darigabat in trial of this and control better seeks advance unmet tremendous indication need of important seizures. area for address who their

affected industry. enrollment will more Ray headwinds detail, across the trial in that are COVID As discuss delays been has by clinical causing post

data in landscape these announced we XXXX. today for challenges, Given expect trial that no we have longer this

robust complete line recently implementing the Tavapadon, done review sites are we are plans clinical a with we've of and trial. time to this conducting thorough As the trial mitigation actively REALIZE and

time provide an will We line update revised mid-year. on by that

side not have potential and the the which effects important the address only disorders, confidence for of it's in of given unmet selectivity of in we tremendous believe needs medical diazepines. but epilepsy treatment plagues occurrence to the its the anxiety of potential We Alpha-X driver the that related subunit of Darigabat main receptor avoidance is

results well. last data we year differentiated our time from positive Phase and treatment which the of in this the of anxiety. panic II These in was quarter this our volunteer top-line evidence trial that remains about We're disorders strong breakthrough an symptom and enthusiastic daily anxiety-related treatment as maintenance initiating potential that track would Darigabat's healthy well-tolerated I provide for a Phase in be model. Darigabat second It a in shared on clinical trial as important of year our panic

as Emraclidine head half year. expect is XXXX, continued of fiscal we trials Phase execution next we with mid-to-late As we when our II schizophrenia XXXX, X stage focus of first our data for the readouts, starting a and on in data-rich into X begin discipline

expect to to our had cash we continue of maximize our as we million our the will highest fund XXXX of into opportunities our ongoing priority value in $XXX and of spending we operations resources on XXXX, pipeline programs. efforts the look of target creative which to for end As the we be

will opportunity a exciting biotechnology in private all Ceesay, our him Ab want be I also wish his leadership thank company. I Ab next contributions for to leaving we Cerevel as to to many an want X well and Finally, March President, endeavors. Cerevel at CEO that and publicly of his to pursue acknowledge

let me call to Sanchez, programs. that, now some color Officer, provide our to With Ray? the added over our lead Dr. Medical Chief regarding Ray turn

Raymond Sanchez

to you. and Thank morning good all you of Tony

Tony our As the neuroscience mentioned, productive challenging will some XXXX was value a of continue just to year to the the that of unlock treat most to diseases. us potential allow and pipeline

Let's Emraclidine. first turn to

are and enrolling robust Our II track. trials well are on very Phase

to expect in data and to of the half look this We year. momentum forward next continue first

worldwide are headwinds will trials called of These facing the XXX not are the for that psychotic and inpatient Emraclidine the that schizophrenia are mostly in and setting. seeing experiencing exacerbation adequately trials, powered X living EMPOWER observing adults we symptoms. for randomize X-arm being are an and ongoing X outpatient We X each with type same of acute EMPOWER conducted trials

test while explore parallel the reducing these response. a the registrational dose will these the placebo expect The of the with enables arms variability on placebo. pivotal daily minimizing of observed meet daily Emraclidine and milligrams evaluate Emraclidine XX to trials XX the the therapeutic to placebo first once trials in milligrams clinical X the trial of Running Emraclidine number will criteria second trials We once test will trial based what in hope versus FDA we trials in XX necessary service us versus potentially fully range treatment designed package. and and XX and to the

a progress. a order is known the we X. open-label In program for have Emraclidine and cornerstone am This EMPOWER to very potentially safety XX-week with moved trial, in our with of package Cerevel I registrational as accelerate forward pleased a schizophrenia, initiation extension for

was development increase an with positive cause living dosing risk in confirmed Our blood pressure which bolstered ambulatory chronic schizophrenia provided pressure of this in results we momentum step sustained the people by that announced in in program. monitoring December mitigation the blood with and a trial an does not important continued Emraclidine in

data these important clinical vital we development speaks in behind have for our thoughtful us milestone this program. generate to to decision benefits of approach and and the pipeline happy to Our proactive this are earlier

Emraclidine be we [indiscernible]. psychosis. patient support their clinical The other the around is ones stigma that selectively Alzheimer's symptoms the psychosis. development pathway, the distressing by MX fear with Phase benefits including targeting of hope development of antipsychotic harness delusions disease the volunteer continue and while also associated incredibly elderly I the elderly can our healthy guide and and to disease. of progress disease loved trial and We drive results in our in volunteer It can our can hallucinations for Alzheimer's effects side to will ADP, The healthy the minimizing trial plan

of treatment available currently option epilepsy and benzodiazepines. but for side Darigabat GABA development our mechanism to the tolerability Darigabat, allosteric anxiolytic can has panic in new and action now currently Turning nonselective need potential significant expected alpha-X/X/X the and area. A in effects provides Darigabat's modulator mechanism that profile from antiepileptic unmet a receptor reduced chronically, with results potential both used this of for comparable disorder. activity We for to novel believe addressing be positive the selective a also that benzodiazepine

REALIZE trial progressing. Our is Phase II

been the trials. range delays of in broad Tony as Although that clinical a impacted mentioned, it by has headwinds causing are

via analyses the these own available experience. clinicaltrials.gov in in of which have lines of and our other thorough supporting scope corroborate delays trial We and industry a time industry-wide CRO review data validated direct peer

medications in of the been has Darigabat use target addition, population. In affected concomitant by the excluded

longer no data this return mid-year. of As and lines, review a trial conducting will these we result an we in time year process expect thorough the the of update factors, by of are a with

important to therapy. are in We this steadfast commitment advance our

add mitigations We Asia strong importantly, seen XX% to added challenges have have new speaks patients countries on benefit to focal headwinds to of sites and associated remaining the in by plan historical an year focused which we additional We're our continually to sites in the experienced We epilepsy. Darigabat enrollment ongoing open-label has quality. data new last in the team we that our where deploying encouraged rollover in address to trial experience. the is team efforts the with Pacific while extension potential to-date rate REALIZE region over

This of has the doom, the the pain, present trial making about initiation and quarter symptoms, We second excited Phase of that disorder believe Darigabat rate, rapid these of disorder. people patients potential including weakness, potential transform anxiety experience of effects We're our important to correct, well-tolerated in episodic limiting a panic II compared the Panic attack. If the the panic sense side with expanding of even minimizing heart the in with PAM sparing and nonselective as such A Darigabat in pounding a of while GABA of a Darigabat treatment episodes attack due provide in option this disorder the anxiety-related chest impending disorientation shifting the experiencing of may applications through benzodiazepines. use year. potentially of could they benefit, provide with daily for are side the paradigm terms to dizziness, some of panic feel heart be benzodiazepines would constellation effects. living and

million our from as Turning Parkinson's the DX/DX that in XXXX. double to the in Tavapadon partial disease a We approximately early a monotherapy cases monotherapy burden million $XX now agonist with XXXX of reduced believe in and effect serve both preferred The Parkinson's for can number side disease therapies. in potentially adjunctive development as Tavapadon compared to expected treatment. is existing $X to worldwide with

for profile more for due delaying of incidence advanced improved with symptom a be treatment goal dyskinesias dose allowing of need longer tolerability Tavapadon potentially and reduced Parkinson's half-life XX-hour control could its with and the motor the escalation. to preferred For patients, the adjunctive L-Dopa L-Dopa and

XX%. As of in trials rollover also with III are seeing Phase as Tony high ongoing, rates as corresponding Tavapadon TEMPO collectively we the the all along extension known which X over are open-label trials of discussed, our

environment of in were the announced trial Given the thorough across this industry, in program its that a time the challenges review November and clinical we we conducting lines.

new of mitigations, X TEMPOs-X now Pacific XXXX. the mid-XXXX sites expected deployment the and new Asia the and the region, TEMPO-X data expect including data second for in for we of in opening With of in half

XXXX. dementia-related we read in of apathy, the also novel half in are other pursuing the program, Our expected indication CVL-XXX DX/DX to second is out of which

updating of the that our and advance trials team continue external the challenges I'm assets. we we importantly, look X remain clinical the mid- compromising experienced trials to ahead and an late-stage from is on the maintaining experiences. of on for to environment as focused data we We navigating have you forward collection of not progress pipeline of conduct our We to of quality XXXX. addressing data clinical the in to as sake looking and the neuroscience deep broad

Renger, With Officer, that, stage will an on Chief Dr. John? John our our portfolio. early update provide Scientific

John Renger

KORA withdrawal research our new everyone. by depression, or receptor kappa primates early has opioid like of and is This action morning, opioid year to exciting and productive speaking Good mechanism very our Thank models. Ray. antagonist you, a XXXX shown clinical for to CVL-XXX. in programs. begin anhedonia selective preclinically I'd

proof saw We major by a a in of recently one also depressive demonstration disorder II Phase trial of of our clinical completed concept peers.

followed planned up inform receptor exploration humans. and to selectivity binding multiple occupancy human in Our nonhuman confirmed primates CVL-XXX selectivity at of recent will We subtype the target our mere kappa PET demonstrated studies binding important occupancy PET indications. appropriate studies. new that receptor be potent will be set These believe trial, a ranging receptor XXX CVL-XXX data with of more dose tenfold occupancy with revealed potential by receptor the of This our receptor presentations PET have receptors. scientific in and and than in of compound kappa examining clinical CVL-XXX, engagement dose-dependent receptors least

in upon our selectivity As experience Emraclidine. of we Tony believe mentioned, with based strongly in-force clinical potential the

As full our we've advancing molecule a lead selective program and in have are agonist previously, disclosed we identified candidate MX XXXX. clinical we

Our those pharmacological that approach to based the science current understanding progress our beyond be may expansion to future. may of Emraclidine, enable ability that excitement forward our underpinning receptor updating this our behind confidence the in about near creation and strongly full to franchise. program look supports selectivity a apply of selectivity We agonist in-force the indication aligned most an further on therapeutic the

and in teams want development. hard I the early-stage are sincerely thank at to who research work

to neuroscience diseases our brain and unravel and As promises of what passionate, I'm experienced skilled do. to very the they the XXXX. productive we mysteries are what at scientists are excited purpose-built a treat about be you to know,

Officer, Chief who our I'm will now Bodenrader, going full performance for the the Interim Financial Cerevel's quarter review to hand it Mark? year. and over to fourth Mark financial

Mark Bodenrader

and position. I'm everyone. our few I'll start on of financial John Thank provide outlook. financial position morning discussing an XXXX results our then and good to by spend Cerevel's and a overview I'll you pleased strong cash financial moments

will investments in exercise value highest we on we our our to continue the Importantly, discipline fiscal target as spend and pipeline. opportunities

As million, by of financial totaled August, $XXX strong reinforcing December the completed and $XXX million equivalents cash, last our cash bolstered securities financing XXXX, Cerevel's XX, marketable position.

the our allow cash operations XXXX the will next readouts resources point us to fund Our are expected which of into our inflection through support data we XXXX mid-to-late for X and to stage us in programs. expect achieve each lead

R&D supporting program, advancement in our were XXXX XXXX, increased R&D year expense including in $XXX $XXX in of full trials by discovery approximately later-stage growth robust expense Phase operating and clinical investment early infrastructure and personnel For approximately was efforts The which investment and of programs, G&A over initiation and million includes total of $XX million expenses schizophrenia. million II primarily of the due other of million. pipeline. Emraclidine to continued other continued costs which XXXX expense the $XXX our our our our for expansion

support for over equity-based compensation primarily million $XX.X included also XXXX, XXXX for million million expense the XXXX advancement costs also included personnel costs XXXX XXXX. to to approximately of increased for of versus $XX.X expense higher relative to and compensation by and for $XX programs. expense of expense organizational our G&A G&A expense other R&D due million equity-based growth XXXX. $X.X for million $XX.X

and trial in our for will our spend proactively review our gate to plans we continue spending opportunities commensurate appropriate. time XXXX, shift with For monitor and operating plan, to adjust as lines manage

where is continue believe Tony value as potential. long-term we'll invest there And our in mentioned, to creation pipeline we

XXXX ongoing R&D our focus comprehensive priorities, in to Phase trial consistent psychosis, for Darigabat disorder the on our spending volunteers programs. elderly other for disease of including initiated Phase Phase Emraclidine to to advancement initiating the in support Emraclidine in expenses Looking advancing we our our as G&A program quarter forward, compared the fourth remain recently schizophrenia I XXXX of development in healthy continuing lead the our for of II and Alzheimer's trial we will top our and panic expect II relatively

well of cash programs, data each achieve for will remain with next to mid-to-late operations our in we lead the resources point our allow readouts to closing, capitalized the into expect X we XXXX including expected us stage inflection XXXX. In that fund

hand now remarks. for Tony the closing will I to over call back

Anthony Coles

from thank far joining diseases. results. year We're accomplished very pleased patients XXXX and proud of all with have to Mark you Thanks full team the and debilitating what we our needed bringing us discuss our work in for so doing the to suffering pursuit of is medications neuroscience much

in momentum in program maintaining priority our schizophrenia. is top adults Emraclidine living Our the with

industry We to and deliver readouts companies I of the other will both pipeline earlier rest Ray data expect the and to and mentioned to continue experiencing that we mitigation measures X our deploy XXXX. are the offset advance the to headwinds in

in will programs. spend we always, disciplined value highest the fiscally focusing As be our on

and So we value cash I'll through looking the point of XXXX posted into our to deal open on coming opportunities maintain remain underscore will keeping We're our to throughout year. and runway Mark's creative the new you to forward making. progress our programs maximize

floor questions. And with open that, let for me the Operator?

Operator

Thank with question of line first Jefferies. Michael you. Instructions] [Operator coming our the from Yee And

Michael Yee

the for going be different as there there are half Darigabat? doing schizophrenia, in read-through or Tony Tavapadon, you're new question first the for timing will as the Thanks what of just if what are was you what update. And for you're improvements the could things Emraclidine learnings wondering ongoing for for analysis are as Tavapadon had Darigabat on timing the are We a that reclarify potential I sort saying a epilepsy. updates in of versus the the well the around around to -- 'XX.

programs? the given So sense. changes of think to sort towards data the I schizophrenia, for your confidence makes X other that for want I your test

Anthony Coles

me with couple going continue of to said has ask One, points. Ray to to does comment we've that well. make indeed the let very specificity. Emraclidine well But Yes, a Mike, quick for enrollment I'm some that's proceeded and very clear. proceed

it's it's inpatient and a more controlled circumstances may this Some of trial be an that setting.

the side generally some And outpatient trial headwinds more that these the industry trials appear we across occur to on are things. of of seeing

expecting confidence us we that some Emraclidine change certainly program in or that the at of So there's expectation in gives half data the our moment, XXXX. the are guidance schizophrenia and for no our first in those

factors. at of the the rest new circumstances We've around that number observing a result trials on We've to this sites, the dynamic trial in we're academic this are pretty note arms of industry discontinuities about the headwinds and the trials that macro X-month some that to to clinicaltrials.gov, a and we by done As a others that get the talked there clinical clinical set there, same review to certainly previous our of a there environmental are these run calls, our at the post-COVID the least likely centers displacement and a environment. companies dozen recruit just exhaustive at personnel particular shortages experiencing and XX-month the of of in are and to encountering. of are delays sites nearly ability affected staffing their things trials research and number the of

So the I to trying offer that, and is and Mike, think just question. as your really I because everything landscape, context landscape understand

you and of speak being relevant experienced some more and broadly number companies across trial Tavapadon the things Darigabat why are to expect is don't microenvironmental to program, some Darigabat. Tavapadon provide more the specific can program by and a comment but industry. specific design bigger But There the Ray, those factors on the of where we issue you enrollment

particular. Emraclidine studies about dispensed I've question, but track on your with we as are in those talk X think I

Raymond Sanchez

hear you. to from Good

So start first. with for that Tavapadon, we'll

same for adding line in year. end, XXX that the to will this we've To second Asia read in experienced of us additional rescue time those read we're The and sites will up much as mid-XXXX. the region as adjunctive exists. trials running the And the half XXXX. challenges that and monotherapy that will which As is order later be the possible, out in in Tony in mentioned, the trial landscape Pacific

but by encouraged lines. we're to that committed So time those we're

we the the In concomitant the in mitigation overall middle plans landscape of since implemented also were last Darigabat we year, in impacted but medication terms by of program, the epilepsy challenges.

to about you takes as implement to the months to know, enrollment months However, it another impact. X or X X contingencies months see these so in

that. encouraged And were a as will we that really late XXXX, that taking currently good and industry not while out readout momentum to January, in not by we're So is know last we these there midyear. not for effect. observed and by we plan implemented year read new we our offset had in mentioned could update It lines mitigations We the earlier time data headwinds.

Anthony Coles

Ray, point data our this next we just team I rest on and you the me before question, the always for is focus maintaining -- that Operator, and take intense the make of quality.

Raymond Sanchez

That's right.

Anthony Coles

the And we'll pharma risk suffer one in rescue of to data the large the large if of one partners in this to quality more things and the add of pharma saw issues in the the question quality you a a -- I they everyone, things attention had. patients. quality the be, last So the sites that time And could about announcement a simple draw just is we terms just -- enrollment of week the lines. some data actually that of the company of of this of doing

clear on quality. maintaining data focus repeat to And quality think our want I and don't data that. we So

So trials high-quality we deliver really information important. into is these

feel not append that probably piece. more I'm that. by free but to there's So to really compelled that on add

Raymond Sanchez

all And try Tony's That's to we to point, variability our trials. right. the of clinical in minimize

likelihood the is success greatest of the ensuring that know, you objective. As key really

want mitigation it unfortunately, many when to don't So by risk They effect you time trials any by you're adding the take take not sites. in time. means to place, doing they're too real put but in

the really patients. of to try important sooner is we get of readout the medications also to the quality maintaining how timing later And so of the the of but understand the trial than part challenge that's the to

Anthony Coles

Operator, question. we'll next take the

Operator

the question And line our Harrison Stanley. from coming of next Matthew Morgan with

Max Skor

enrollment? and on can you COVID issues? additional Harrison. you changed the could from thoughts the following to any Have Matthew trial? improve rates? you rationale the potential Skor And for on the provide Max also just the key disorder is previous enrollment panic that design for comments, criteria But on on And risk This the could impact placebo any up comment

Anthony Coles

why those? you take don't Ray, both of

Raymond Sanchez

Yes.

we no, in changed criteria have the of the So not trials. any

trials and data moving we'll that those forward. think focus the I designed continue on of were to well quality

any moving amended forward. those not the of protocols question. we've And second So

Anthony Coles

Would you -- panic disorder design. study

Raymond Sanchez

Yes.

So quarter we plan year. design year the disclose are program currently initiate finalizing of trial will second this it's but track. later we that this in and on And the to we that

Operator

next with question our And coming Stifel. from the line Matteis of Paul

Paul Matteis

and I financial have one question one clinical.

to seem you study, And rate outcome the elderly there. pursuing lay therapeutic like feel same out trial you index? be could clinical to what's And ADP line the the higher like? can naturally. expound On your on a then you've was the this adverse that into could schizophrenia? getting would clinical no would risk could with on math on wrong, more that from of expound so cash in to get readout if It ideal like the schizophrenia the would catalysts bit the positive And muscarinic side, do little of helpful you XX dose just going it in seem year. been the acceptable event you would on if is finance looks I waiting that data until need is wondering run maybe to but like on in you positive than side, months it be XXXX. a but you cash an now cushion world, there's more Where's a finance healthy In right, what

Anthony Coles

Okay.

on Let me ask of then make question, Mark to comments a the couple finance general comment specifically. I'll

do, and Paul, into for to that trials dollars as for is The that to talked that additional to today. One expenditures of for or know, obviously, the clearly be is is that consistently can we'll is inflection be do what everything one get of that reinvested that's budget unused sweep it put forward our the the the cushion we've XXXX. the XXXX we doing. in investments things next about we things we point you make true But

data can all possible. on that long this how to as give don't doing today additional basis specific real But cash why We're time readouts confident So and we're that for will opportunities sure ongoing to cash and some create we extend of we'll about us make in value as in you runway the about do management. an we our make think that the we've Mark, earlier talked about continue pipeline. cash comments that to

Mark Bodenrader

Yes. And runway carefully runway our financing we're extended to will XXXX. But have readouts a the the basis. pretty through we about earlier. and really our but our on data us that the -- runway with our with evaluating on we've And cash we do our catalysts. spoke is our support of cash we're We happy cash matching strength making of balance that think And runway. that regular will sheet. Tony X a done Sure, can job good sure always management we Tony. very as focus constantly choices focused cash And on mentioned, we're maintaining cash

Anthony Coles

Renger, And would you ADP? Good. dosing John about in mind talking

John Renger

you, Sure. and for Thank question, Paul. Tony the thanks

you looking the so age Phase tolerability the for healthy population. yes, in as what and looking in we're study, we're I know, So safety for study, any for target elderly

as this occupancy And in we've you dose. receptor by characterized so know, case,

As you occupancy know, the receptor on occupancy in to range. Also the we we or greater. to be study. aware, probably a and data exposure that schizophrenia very support earlier XX% from analysis have score would expect of same correlating data getting Paul, PAM We with of as the impact to careful do need we done PK you're receptor have

safety population care ultimately. of will standard that treating top the in type of think some Alzheimer's do population tolerability be and on know, you relevant acetycholine the as However, to of We is the esterase the inhibitor.

as elderly it's tolerated really dose that population we into have getting the that receptor to population characterize with elderly then occupancy the safe to moving is forward in validate we'll so, care. study. And But us, standard past healthy that the for to patient XX% go and of and the

actually And you a on It as you what actually PAMs is acetylcholinesterase can that's because, been acetylcholine see that binding. standard is the shows a you know, there's encourage you of of done when bind peer benefit increase as been ability some PAM to PAM to care that know, added the in a a by actually inhibitor, binding characterization company. that or

we from tapering there the at a that point. standard the be of believe into PAM population actually so boost And can that care, the healthy efficacy population of into with a patient

we'll ahead interaction good we on so of data want and occupancy range to and but look in that we're have around all the very at occur patients. will to to we thinking And exposure dose the get receptor the a based care what of PET have standard idea

hope that helps. I

Paul Matteis

Thanks. John. Yes,

Anthony Coles

And dosing [indiscernible]. once the

Paul Matteis

Yes, that actually. was my follow-up

in confident You're well? for population this as QD

John Renger

Absolutely, yes.

no going the in know, be important those is burden concern in to it's a med population So will really cognitively once-a-day population, how this you you important. meds particular be that challenged very as and dosing is manage for serious titration because

formulation so once-a-day will really here. be And having a key

Operator

Our Fye next Jessica of line with question coming from JPMorgan. the

Jessica Fye

Two me. for Great.

development First, what stage areas profile? with II be then from when what establish or the EMPOWER product Darigabat competitive looking Phase to the specifically to at for up second, you to starting of on drugs differentiation specifically do readout, are that a studies And to Emraclidine, going in other you schizophrenia? in disorder, trial or approved that define panic for support show think needs clinically

Anthony Coles

of ask Okay. are Ray marketing to Go we those trial. then Thanks of about ahead. And we're to the couple Jess, design a the that of questions. or that want on actually question. comments, thinking both the I'm make comment going I for on to how endpoints considering

Raymond Sanchez

for question. thanks the Jess,

the currently for quarter the panic are just So started of trial disorder we this finalizing year. second that

since been XXXX. As a there for panic approved you know, therapy disorder hasn't

attacks, typically, probably what for weeks the panic FDA of takes on So that longer it's reduction the been usually weeks a are about since symptoms is time period it in really These for couple the trials XX of go duration to last actually trial. the of for of looking But mitigate for in panic is time. XX years.

premise the plan those disclose this the with design year. the that's agency. of we But in will that So second trial after general interactions is quarter to the we've had again, and start

at looking of the as of terms the what you mean change standard they in score. for, baseline total we're looking from are In on PANSS Emraclidine, we're trials that terms know, pretty

also be change function Those in in at placebo-adjusted We'll to least trials looking X total also as of the we'll change that a are PANSS difference. power a XX% understanding PANSS placebo. score. at point be So

that collectively. looking be we'll So at

profile important. tolerability also the course, Of is

its I to collectively understanding range treat of as totality, to there, approval of XX serve for profile XX we'll tolerability and submit Emraclidine to well as schizophrenia. milligrams the the full will the package that dose agency think profile milligrams the taking in So understanding efficacy the the as

Anthony Coles

And this the up, Darigabat, data prescribing for We we terms we in a matters limit I for what dependents, effects central And half just be are should call we side it think correct a available. currently withdrawal now, for benzodiazepine positioning. what's think sense those case I'll second right will rather the framing by in would the benzodiazepine. in potential are then largely is duration of as your those of of the and with in And end. deliver one is targeted big a what in which profile on be patients of matters. unifying Cerevel side it -- common shorter-term to we the the then some observed competitive and than with cetera this hold which longer-term selectivity effects of notion able think we while to deal et improving benefit duration start if because those the always of which receptor avoiding and that know both panic that the for in I'll question are each tolerability thesis the in efficacy epilepsy, that

the in-market for we by currently that for selectivity this in being we'll and that patients be development experienced will distinguishing programs. as we some fragile But effects Emraclidine, and a of the need side similarly, of importantly for think make and stage avoiding population, to are matters dosing once think terms daily providers. no And patients features titration, difference in

receptor targeted it selectivity to is always central because thesis in So back reason Cerevel to draw the us I'll that and of our believe programs. in unifying

Operator

the Evercore Raffat line with coming Thank from you. ISI. question next And our from Umer

Umer Raffat

I trial is you'd hallucinations and even Lilly perhaps something in expect cognition. as is couple focus from side the the when I'm can program, you're Alzheimer's from I'm to a I trying program. theoretically, curious, just that study go Alzheimer's trial agitation, could I And well? into do may, is Secondly, healthy understand the on there the patients. know of we have why about Alzheimer's first, if And I on the some right Is the data first. old you thinking side? evidence the the here, curious that was Perhaps how earliest Alzheimer's actually endpoint.

on relevant then was selective broke wasn't allosteric which that also they data modulator Merck MX in out finally, is you agitation. anything I'm if understand never here? there And positive study cognition and there's but successful really hallucinations curious from which a

Anthony Coles

to John respond I ask to we'll Renger and answers JR? attach us. questions for those think

John Renger

Thanks, Sure. Umer.

yes. So

which this first, patient tolerability that safety don't go to population because establish out actually and and the population concern it's in you of we number the there approach a in want show dose healthy why to have, think before the population healthy to go issue patient test And safety we a a don't obviously, do with patients as a always, just need a is and go you of it's into the go tolerability or range population we healthy into you into safety the exposures So in intend so forward. tolerability at you patients but point, find want to you first? standard if to

do industry an So to it's standard practice that.

as dose we Phase so I ascending study. actually you that multiple study announced is know, the And a

before we duration. we'll dose dose something they review that the those that not weeks range. each in haven't cohort, safety And when out. go go cohorts, through -- about so we have next should will those it's number and hearing be will for back. And you be of But And the tolerability X a come that a announced And escalation. that we've data and we'll cohorts to talked far future after into

Anthony Coles

have go don't JR, which in to elderly here. actually just currently we data we response, to need you the the collect second before is what part of

younger. So because obviously for everyone skews just little schizophrenia that I a underscore bit

we've to in collect that data -- this population. So go in this got older

John Renger

Thanks, Tony. Yes.

believe, looking at delusions, and hallucinations Another question study. hallucinations Umer, at agitation and you looking I not agitation, was we're mentioned had and in that you actually that

be So would an study agitation separate.

population, AD a have So what planned we're for will delusions, different the study looking that in in particular, at that's we study is and at separate slightly looking be hallucinations the from population. an agitation which

that's relevance tolerability great mechanism safety we're And know the MX with potential And on is about the schizophrenia for and of our the and part believe doing we cognition with on. what for so actually is that focused expression MX of what brain and is that the we the ideal experience. receptors hallucinations based in it's delusions is showing really what the there stratum obviously, targeting we're underlies

could pseudo-specificity have increase you in address might would issues. see of a in that cognition you see a but you potential Obviously, cognition address benefit you also to the once those

a looking so at trial And purely separate cognition design. is

a the addressing at that And do cognitive benefit from so benefit the you'd a for look then separate have treated a to what cognition and patient achieve the is delusions. benefit really population in and looking from stably hallucinations might to

and you've even population of separate a from have would where this suppression that. away hallucinations patient to that separate study design in or population delusions so And achieved a be a

beyond at little point. this what a talked bit actually doing now we've it's So right about

compound. your point Merck to and And about their

So as know, on. going those were was company studies that I time you particular at at the

release They which activities looking areas was published very X that agency that point the it's looking at things, for review. and improvement the were of wants hallucinations really available. that diluting to standard on is at kind of at the any and are and So There data at not ADAS-Cog data on publicly looking focused delusions.

good things outburst, in refer on study. that in dose-dependent anomaly out effects data to which this would like hallucinations addressing I paranoia, you However, really actually showed

in gave to role where selective the works compound active excitement population. patient a bringing a able to lot confidence our and of address really in into can those the the highly being it and that we address around an a Alzheimer's compound for of know issues MX it a disease psychosis aspect for and drives So import space particular really potential

the to So we and really the an hallucinations and MX the to really appropriate be would study cognition design delusions that address further population. separate going a piece, do believe be that approaching patient to able is a

Operator

And from with next question Duncan Charles of coming Cantor. line the our

Charles Duncan

programs. on had I X the Emraclidine

off or first EMPOWER you other measure? to in just enrollment referring some is EMPOWER give -- is color question and was rate EMPOWER how mentioned taken numbers provide of works? rollover not, back sense patients or, geographic more sites X, the the extension. of open-label And X specifically phenotypic the us even that perhaps put going that drug Could second with you and of a say, patient The regarding terms spread a X, if Do you little then persistent well. that in And and to regard X? then can you are in Were enrolling on?

Anthony Coles

Okay. for why of take both those you Emraclidine. Ray, don't

Raymond Sanchez

Sure.

-- and enrolling of well. those that trials are terms they progressing in So are

X and So and EMPOWER earlier when we're it's enrollment we both the that that EMPOWER seeing in X. mentioned really

it NDA filed of X on least target In the X of be the But drug is, as total what at XX really for exposures. X therapy to they those on investigator needed roll who's us terms over package added And and when XXX open-label who's lasts are for the of weeks. on so the they know we X get of will placebo. at serve and we year open-label happens at start at approval the you EMPOWERs do and the extension least and that they can will participant be drug, schizophrenia. up in months if then on extension dosing it's to the EMPOWER treatment determine at X, But blinded, know, XXX don't and as to tolerability doses into of what the wants

Anthony Coles

is when we going enrollment then well. enrollment said that the piece, And

Raymond Sanchez

We mentioned that we that earlier. Yes, will. hope

Operator

of line Mohit with the Bansal Wells from coming Fargo. question next Our

Mohit Bansal

Great. And dwell Darigabat here. to wanted just the more delay on

Lilly because getting we against well, exactly ask enrollment to I setting. going is Alzheimer's time ADUHELM, at is is mentioned head-to-head understand at as to you on patients looking looking trials which and a like understand like they where finishing trial which are a Are mean I what it trial at on issue on outpatient we time. you because not the epilepsy want ran is Because as are time follow-up also Or I on? diagnosed -- going would issue? or I it finished stand, for wanted much? to So

this bit trials understand So you well? little trial, setting? particular, as in why delayed it difficult What other a looking at outpatient getting in to seems are

Anthony Coles

as the to commenting So pull a other we say, suffice I companies X- number that on We for of ask area. landscape, to is announcing are specific And including Cerevel thanks clinicaltrials.gov occurring make won't of habit the because other specifically. epilepsy a the XX-month to appropriate. say team What they we headwinds to actually across these well. or be names, companies that, therapeutic that there relevant we question. and wouldn't can -- peculiar industry But neuroscience, are in don't mention don't the even are across information not or particular are to delays larger

trial which considerations specific inclusion to additional through. are the some as indeed, add criteria we And addressing And for sites. the the do we working that one Darigabat be of have expect for we we things

of several are tell delivery in a all XXXX. industry, well, there important good of execute is unfortunate milestones What you can examples. team as the witnessed they headwinds that number are think that us I executes, when as in these I the the really of So very for

it's top when and and that's our we of control, plans we issues and work in the our game. as to it's execute to team at is doing. put outside the these we in effectively our quickly control, mitigation So as of can what When address

Operator

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

Douglas Tsao

the to extension of should positioned or follow-up way how affect open-label expect you I'm read do completion they as a II studies after out we will. of timing file they a just quickly curious, you'd Just potentially the sense if be that on Emraclidine, Phase that how have for the

Anthony Coles

Ray?

Raymond Sanchez

the for you thank So question.

path open-label X done typically and comprised this the submission who open-label not rate to over both up the critical de X. Emraclidine is of is NDA. that are also XX -- extension so from novo extension to the the EMPOWERs the ensure individual sites is we patients we're or actually adding roll and of on to So But limiting

X rollovers X, for we enroll time be will NDA from So patients submission. as able our currently complete de that being able to as is are EMPOWERs hope that timely to in starting trial that have by well that novo and to

Anthony Coles

I What's Operator, good. we for questions. just more time very next? think have Okay, X

Operator

Certainly.

question from coming Graig line from next of Our the Suvannavejh Mizuho Group.

Graig Suvannavejh

in a that's deprioritization company think internally wondering for months a a programs bit you. about XXXX. the at nice and or I going got thought the you is a further environment in maybe of picture. reasons and that time past to bigger Certainly, It's into that or been question any had for programs? that against? the on, got over the balance better of you've you've a given discussed taking what everything want know, within just prioritization set Tony, you're whether saying a point certain I'm And XX-plus we've cash so. Has Just financing given been seen to there

Anthony Coles

Yes, Graig. question. the Thanks for

Just of things. a couple

do the as that programs our very And programs is of value is and of One way and hard term. do artful executive a tried highest investments the and patients between opportunities. highest early-stage know programs into just deliver is long we decisions the the dollars the artful returning we thing way we prioritize the fund set most the but our of balance will about value One Cerevel everything. good to beauties we do our and management. up stage in invested mid-to-late specific And have for the not have value that's that programs art returning biotech just we important we the to are also an well making really those near-term and that the can't shareholders create to work and how

well as transactions risk-sharing consistent we're and we outs. well a of as record those basis doing with got open Tavapadon a talked about kinds and partnerships. think have track we variety So a to arrangements. NovaQuest I for of but ideas fact we as to ins potentially do of arrangement about the We've And that do, that financial we've like and interesting Bain that and as interesting the the open also, as the on are should we

dollars and to the our way. So deploy effective process of that at perspective form think basis that on you about how capitalizing to the most a allows We we review we think potentially we do how a in I we how robust think prioritizing look us twice business, have the capital year a programs. prioritization have that composite nonequity-dilutive about portfolio our

being right I got your of the on in CEO finger So company. art great appreciate you a and a biotech the question

Operator

last question coming Kumar our Sachs. the Madhu of from Goldman And with is line

Unidentified Analyst

for questions. Madhu. is a This on have of Omari couple I [ph]

think Emraclidine about the safety, and First, terms catalyst how path in near-term? second, patients about the the PK PD. of elderly should we be trial for for thinking And we the how then in should company in

Anthony Coles

Great. JR, question? the want do you ADP to take

John Renger

the Thanks question. Yes. for

in MX of the functioning. not I the that they paper. of disease population. that by the to Alzheimer's established expression we [indiscernible] a we've present [indiscernible] largely they are retention recent been MX there they're examined conservation muscarinic think acetylcholinesterase and So was there's study the PET used but patients, To inhibitors is a younger compound that -- those established activity that some about way the there receptors in receptor while and at What think previously was decrease that also still through that the in-forced the MX only demonstrated ongoing know of use is that that publication occupancy look schizophrenia using in they

be we that's an the that functioning MX selected both the still and with of charging it And still is it suggests it's well [ph] educational there, care. because as is potentiated that, so as what think very that molecule, can standard

that is And to we'll that, we going baseline ranging healthy looking elderly we dose into looking at we're that take study establish patients. at Once forward. the tolerability want X-week to so confirm safety and this really be

really the at appropriate appropriate with And up think is really examining safety should progress allow I will med earlier. once-a-day group non-titration you're the us have into us is a in the as AD study age really as formulation to so is, tolerability years that what is what carry looking that important to going we far indication. dose to having XX showing approach is range here I intend population management, in And we population the be the at to that be forward and to think looking that important, once-a-day patients that this we we old again, as mentioned want in to

one safety to plan dose And to is receptor studies. the as really appropriate occupancy and the establish tolerability that inform of us set going so we really really, next move support our forward achieving at looking steps with this range, helping how we're next to and

Anthony Coles

And X Emraclidine data of a XXXX. mid-to-late That's next the X are we talked readouts first catalysts, for year. in expected about as the have lot to which in stage we've half

well. III the Darigabat, We Phase will X update for program an on in expect and the further comprised we year Tavapadon, data obviously. which XXX studies next as

the bringing to looking all to lot to. to So forward a we've focus work be you that got we we and a got on, on lot updates we'll need

I next I will think, developments operator, thank for look touch We morning we quarter. additional you as want us you. about that's arise. forward joining in this and Thank time. be chatting with to everyone to they with

Operator

for Ladies conclude does our Thank for today. participation. conference and gentlemen, you that your

You may now disconnect.

Cerevel Therapeutics (CERE) 22 Feb 232022 Q4 Earnings call transcript