CERE - Earnings call transcript Q4 2021 | Cerevel Therapeutics Holdings Inc

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Operator

Good morning. Welcome to the Cerevel Therapeutics Fourth Quarter and Full Year 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the Q&A portion of the call. Please note that this call maybe recorded. the and to Investor hand President, Calistri, now Strategy Corporate Relations. will call Matt over Vice I

Matthew Calistri

you benefits like encourage among you candidates related to regarding Tony our we views outlook. SEC that Chairperson will to Thank you. XXXX our as would our Dr. Medical Good call that from clinical and and be to, and statements Executive performance our us today's for Renger, Officer; Chief product format refer morning, you I Dr. Dr. the timing uncertainties. press John everyone. over We to our trials. fourth call, Sanchez, Chairperson and attributes appreciate Tony of making strongly of today, Chief quarter reflect our risks Dr. of Officer potential During as CEO corporate and this Bodenrader, Coles, to full provide Scientific call from we of information on Cerevel overview and our both be Financial the Interim and Mark XXXX Ray Officer; of achievements and the forward-looking please with are will specific website. file year will I our Coles, that earnings and morning, to development current activities our our On our call. the our release hearing you product other Chief our joining available which Chief presentation, an Officer; our things, now detailing review updated hand We remind and well

Tony Coles

way well all Cerevel premier neuroscience quarter our XXXX full Matt, the business our results becoming its and of and you is for us joining for good to aspiration fourth Thanks, everyone. company. morning, year call. on achieving Thank

we possible have two transform seen have got results need capital schizophrenia in and positive with that recently born-out the the and what's the people pipeline, have the neuroscience, trial anxiety. in to and we We announced we

schizophrenia First, MX-selective announced allosteric of or we modulator, in emraclidine, for last data Xb in positive June year, positive Phase PAM.

potentially beginning We've from GABAA this of this of on XXX team through targeted forward year the time many as to We weeks Earlier working And XXX size nonselective approach Slide side withdrawal, the at at in including of and an neurocircuitry, and can are targets do results of schizophrenia, the in year. neuroscience is the that is development. GABAA two selectivity, beginning the understanding on employees αX/X/X receptor grounded to announced experienced this PAMs and in details dynamic, Cerevel the treating support X as differentiated to αX/X/X that compound minimize and effect of is to doubled these focused to and approach XX% which anxiety we be limit distinct generate αX so. and PAM. almost episodic deep and only the of data our sedation, clinical disease, profile, These illustrated corporate grown our of middle XXXX We've a known majority activity for research rest potential. our X that clinical in innovative expect just the and this we the pharmacology are comprehensive the have ago, presentation. which soon are bringing creatively spares employees shared programs. to use. selectively trial with working the Phase proof-of-principle over our benzodiazepines impressive for widely a of challenging bring distinguished and subtype initiate anxiolytic therapy as first eager effects year, patients positive demonstrated aggressively to as darigabat, possible, our transformative selective possible, Benzodiazepines in program we to in This clinic that side as and abuse

financial Another secured And of deal funding making. most through in advanced program for bolstered we NDA after a our million we In a innovative that positive of Cerevel April, through deal XXXX robust position, our non-dilutive raised emraclidine which in is submission. through tavapadon July follow-on financing our the $XXX announcement for strength offering we announced data.

As very our XXXX. to capitalized we're into a result, fund well operations

with in but the trials have is from the to Now schizophrenia. to the turning highlight of like XXXX, the half from advancing data of late to our from programs. patients In announced not later data we have depth rapidly addressing stage X suffering forward having to first first portfolio. Slide in of the in Phase follow in Phase two two anxiety, first the our completed, stage Phase and our Phase expect the to trial we're tavapadon important we the expect With rest X Parkinson's, of XXXX, proof-of-concept XX X to for trial we Slide the needs of X in our data data year. readouts year, highlights of the of pipeline We'd apathy. our programs XXXX, dementia-related And focal other emraclidine Xa of neuroscience pipeline, milestones ongoing lead CVL-XXX in and only half epilepsy, of of In looking presentation. the the half second diseases. in the data dementia-related we're schizophrenia Cerevel darigabat epilepsy. breadth already unmet this also half our in which of late early hopes anticipate of ongoing stage Parkinson's upcoming in and Parkinson's Also recently apathy from

advancing, robust clinical an pipeline, the we in Cerevel the a financial treatment to our neuroscience Crossing leveraging and advance have laboratories bringing at diseases. position, Cambridge is and a actively of a position also facility. together In team, pipeline discovery sum, are early state-of-the-art enviable robust talented that We strong a

the key let updates for review to to call our over Now, me Ray? the programs. Officer, Ray Chief our Sanchez, turn lead Dr. Medical

Ray Sanchez

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

transform Cerevel outlined, to in poised has what Tony neuroscience. is possible is truly As

is this year of data the in been to readouts, organization. Our career, seen as a most particular us community. my last has pipeline excitement created of one is great had have which positive exciting be momentous of lot we provider physician a the two The it part in I've and for privilege in

past XX in and reductions had rapidly by stage Phase twice the treatment begin to of respectively. robust development. into daily Let's were showed trial to demonstrated June absolute we schizophrenia, were of Both improvement This of XX. milligram while the outlined points statistically first an of turn Slide daily Phase CVL-XXX symptoms compared milligram gain emraclidine, this next modulator. We XX.X or the doses last schizophrenia of and of Relative our points announced we we improvement demonstrated In versus January, effects results effects, as of announce very positive in with formally positive pleased meaningful XX.X encouraged which MX results extrapyramidal on X groups year. XX.X PANSS and gastrointestinal total significant the on significant XX.X impressive. cohort allosteric moving placebo, with of comprehensive both The that group are of program known to year, will Xb antipsychotic very middle points, side an emraclidine baseline are details meaningful weight data or score. our The points XX clinically once in statistically differences these no placebo. by

dose are to based examine criteria what a generated expected on arms We the on therapeutic meet package trial. in can fully you powered FDA. on Slide to as pivotal, Phase adequately agency X trials will range meant trials emraclidine, in single will minimizing this to the in can the of potentially of placebo final package. Now, service these increased effect is running decision registrational Running a and will up the these data determine sufficient and explore XX, having while the to be trials result two program will both the these approvability that designed four whether parallel two see ultimately data placebo or controlled more The from the we consist we parallel. variability the in of trials necessary

As on trial milligrams evaluate XX, milligrams versus once XX will daily the you'll Slide XX placebo. and see first emraclidine

Each XX adjusted placebo. in is The score detect placebo change of milligrams daily six. to once second trial a trial XX% X and total powered will PANSS evaluate week versus emraclidine the milligrams X Phase at points XX greater or

of in generating NDA accept order from top-line both XXXX. to first data to half trials and plan safety novo database trial, the an filing. these in the of de which In We label open begin initiate expect patients both rollover to the support conjunction, we required extension will

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

be great another strong neuroscience. results from for was Now acute and healthy proof we of daily as moving differentiated approach announced evidence darigabat’s ago, that in represent differentiated volunteer thrilled trial Cerevel’s potential our positive by on data I to might X disorders maintenance in anxiety, Two a darigabat. top-line for anxiety a benzodiazepines. Phase to related contrast to these treatment they believe therapy weeks

darigabat treatment targeting discontinuations, tolerability in see thesis We tolerability treatment by GABAA supports of and meaningful were pleased episodic and clinically treatment our related to optimize αX/X and doses withdrawal of effects minimizing associated subunits the the very see and darigabat of for data that groups. are We This incidence benzodiazepines PAMs receptor, selectively tolerated X As no statistically also mentioned, tested. to are due effect while serious limited the was nonselective no no generally the well issues. with adverse Tony eight anxiolytic to use to days significant encouraged concerns. may their anxiolytic were that after darigabat readout of both events, GABAA darigabat αX symptoms

specific points couple highlight discuss like the a I the before about trial of results. to Now, I design would

sensitivity to one optimized hypercapnia used a short solely an and trial show treatment, duration which this week effect healthy over the relatively to of of approximately First, in ensure occurred. volunteers alprazolam model, was anxiolytic was

titration utilized we for both quick regimen day four doses. very a Second,

the I presentation. XX the to to With again, would like this design corporate trial was detect purpose profile. that attention of mind, to tolerability in than and anxiolytic elucidate turn As rather an safety effect the particular Slide of your

PSL-IV with As total darigabat points stated XX We symptoms. and anxiety here, in the to daily of adjusted X.XXX a symptoms respectively. X X.X you of and score considered would meaningful basis, point milligram list a panic doses X or points X.XXX milligram twice significant and values in adjusted P X.X reduction placebo improvement statistically be that improvements can clinically the a on demonstrated point placebo previously X.X see

of validity confirmed anxiolytic points of activity. exceeded within clinical of the robustness alprazolam expectations this clearly was our are X.X and with model, the and again, quite the effect detecting So, the for for seen impressive results expectations. of model range The

this in study. to was pleased a doses XX% demonstrated be by and this and in tolerability volunteers incidents AEs events of dose we to considered and trial darigabat Although Both quite effect adverse of healthy these The temporal were related of we the reported the in observed appeared titration. anxiolytic of were speed patients, mild. profile pattern not

period to see the expect So event titration in Dr. a us will trial, presentation, in future in details the from populations. Renger what the look may conferences. the provide exposures presenting better we activity trials, to profile Later actual the relationship about adverse learned longer between might scientific some John details trial at patient forward understand on and on drug future we help this we additional and relevant anxiolytic

second As X we of results this a Phase the from our proof-of-concept epilepsy. year, expect reminder, the in trial in focal half

a trial, extension very open-label corresponding which continues a conducting high have rollover to rate. also are We

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

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

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

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

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

forward We indication. for looking path to treatment best closely a with novel forward interacting the in this in are agency developing determining the

the in the Before our any I Ukraine to call wanted over hand Renger, Dr. on and I have trials. may you war the address to questions impact to

trial Ukraine. Our with sites, thoughts of and at indeed all the and are clinical with investigators foremost the first patients people and

research for humanitarian Phase clinical at this crisis Among for believe than an country ongoing are but that TEMPO we in are are program, trial number grave we Specifically do development. Cerevel, important sites our the XX% of in located not clinical and timelines Ukraine. of acutely this our trials impacted X trials a a time, is aware we have all less small clinical tavapadon, for for that

the We planning are execution. in fact, region the take for to proud and while uncertainties meticulous And geopolitical we trial a in we of disruptions ago. approach potential began

started the For drug, contingency, country. we example, pre-shipment January, to of a taking as mitigation in clinical supplies product and including measures

As goals pandemic and with COVID crisis, data and the XX continue as our our are Dr. to operations timelines. to our speak stage John Renger, John? call over across we trial like Scientific I'd about any have in early to enrollment to to constantly past quality, evaluating evolving respect the ensure turn to with integrity, rapidly portfolio. Officer Chief not the clinical meet our with we portfolio we

John Renger

Ray. Good everyone. you, morning, Thank

recent necessary the do confirming a αX/X benefit symptoms. can an really receptors. we and dose important X new humans hypercapnia reduce for validation same healthy who to broad seeking scientists, GABAA volunteers receptor trial this drug acute the are robust from disorders. be These evaluated for panic units, anxiety trial, of patients sparing sub at future clinical to I for that anxiolytic data occupancies are demonstrate that the concurrent containing medical data anxiolytic treatment particular range while scientific and and desperately required the inform targeting selectively levels that clinicians, of clinical related our and best sub first especially achieved exposures mechanisms the First, represents in emphasize on In the unit breakthrough want to and selection the time drug by αX the

occupancies the twice daily XX% XX to αX X.X receptor achieved achieved trial, healthy approximately XX% the preclinical darigabat. sub at of this the anxiolytic receptor XX% GABAA our dose receptor of context, least to As at milligram studies milligram sufficient XX% demonstrate twice activity volunteer while previously were αX that have In shown units daily with occupancy the receptor, occupancy. dose

as XX% that Importantly, to practice receptor the of what setting. twice reduction estimated or anxiety treatment alprazolam lower is symptoms the relative daily dosage dose, as end in patients typically reminder, a a is this an for low the than starting on X of clinical αX achieved with milligram less the at is described the occupancy in level

occupancies dose the in multiple were range the impairment the and clinically or normally are high X is to as sedation, αX/X/X was the investigate at Our occupancy receptor fully such upper order beyond receptor maximal goal of in sub to XX% the achieved with XX% to to high selectively in to discoordination non-selective units The limited bounds cognitive drug study side level extended receptor at higher ataxia, the of body benzodiazepines more of achieved trial this folds of amnesia. that's push in this non-selective benzodiazepines, what occupancy obtaining αX/X which achievable dosages. and use activity of levels effects well for

to the of Our X I'd particularly We're X at formulations. and a counting ascending both we currently enable updated for alternate Disorder GABAA benefit, our beneficial therapy our our CVL-XXX, recently future dose the multiple of a who of the anxiety of as αX The associated therapy. patients for for potential highly occupancy achieved effects the development disorder. on the of and volunteers. anxiolytic depression disorders, our extensive potential levels important consider program of patient we for kappa receptors differentiated and dose this teams From receptor for new receptor as multiple insights are selective the validation to mechanism as the also sparing in our like Cerevel pre-clinical of the information as in eager about potential doses X study a maintenance early we potential trials this in Phase healthy Within the to recent unmet options dose need, pipeline, excited you for very keep will We're giving treatment this αX/X internal Phase this gained daily be avoiding for options data of due with culmination are program may first therapy that we and opioid darigabat for underlie and to areas Major for highlight substance limitations pursue to work in give GABAA provide needed data, accepted supports and use this us exposures and that selectively great an conducting exploring antagonist, treatment have FDA by high potential targeting benzodiazepines. issues action. these be the IND single others clinical amount while Depressive confidence the

well a our directed MX muscarinic scientific the promising leader host also profiles, receptor PAM MX pharmacological complementing with of compounds a as progressing are and of positioned in We emraclidine. identifying range selective

of scientists the evaluating multiple allosteric molecules our already additional modulators clinical potentially receptor advance and are highly the expected the in increasing psychosis-related receptor additional emraclidine. targeted to lead These in expand muscarinic further utility that MX teams agonist lead Our for to much to molecule actively indications, MX we've therapeutic expand space. upon muscarinic area emraclidine into potent are our demonstrated setting clinical potentially therapeutic selective MX additional

As and looking specifics Financial our Cerevel Chief our many and over for extraordinarily Mark? turn and are to beyond. our productive the like been can to in for year forward see, Interim to XXXX Bodenrader, we outlook of you XXXX this an performance I’d exciting financial Officer, to Mark it has now review year. updates

Mark Bodenrader

and XXXX position and financial an on strong provide spend pleased start moments our million, advancement an were of of stage few raises of XXXX. results. million by by in $X.X in Full-year of increased personnel expense runway. XXXX million increased XXXX a Cerevel's expense to cash our also XXXX, $XX compensation financial discovery I'll infrastructure our in of expense growth expense expected G&A increase an for pipeline. last overview to R&D And our $XX position, versus operating later due and year. by continued included then our which $XX efforts, approximately bolstered also R&D $X.X for million early and included for was million Thank for XXXX total G&A XXXX million other personnel the approximately XXXX organizational increased cost capital clinical expense approximately over programs, equity-based costs, to by million. equity-based public company continued $XXX higher for our primarily which R&D costs you, John. I'm compensation includes G&A full I'll $XX.X last year, growth. $XXX a operating to over discussing million to to expense of and the expenses expense expense primarily of support million due investment of $X.X year relative XXXX. other support

as December of XXXX, of securities $XXX to million, As XX, our million cash XXXX. December XX, $XXX $XXX million marketable and totaled compared

Our in by positive completed after cash the position schizophrenia. shortly was in emraclidine $XXX the follow-on offering Phase announcement data July, bolstered Xb for million the of

million these year. we the April, additional second of million warrants. addition, approximately this third under received the and $XX our anticipate And and the an agreements in $XX in in payment public from the million of we receiving redemption quarter In tavapadon under $XX.X our exercise agreements quarter first financing we funding

CVL-XXX our emraclidine, X expect expense this invest efforts. our Looking tavapadon for continue in R&D discovery we and X forward, to our program and early comprehensive continue program year, for continue Phase advance Phase as to we to darigabat, increase initiate to

to addition, this pipeline. we personnel expect the advancement year to continue In of our to R&D costs grow support

growth remain and we expenses G&A support also activities. capitalized. We and efforts our closing, pre-commercialization increase continued well development we expect the initiate of as research to In

forward for of back continue our data strengthening remarks. like cash operations now readouts We value-creating XXXX. the concluding into sheet our couple and to think support we I fund pipeline. hand finally, to to our We creatively multiple look years. Tony to about expect next the opportunistically extensive would call balance And our resources to over further to

Tony Coles

improve lives Thanks, the Mark. advance At diseases. people neuroscience to mission Cerevel, living with we to continue of our

to continued pre-clinical pipeline programs, data rest neuroscience our of reported become we the have than both progress secured We year, and continue the and our extensive capital the in have less in journey two clinical and company. to a make the need premier successful people readouts of to we

depression. unmet neuroscience Our focused in addressing and are patients of our At leveraging for millions ultimately, need anxiety, with we diseases, portfolio, unique needs medications Cerevel, the Parkinson's, new programs are including them. to epilepsy, deep to our on neurocircuitry dementia-related patients high schizophrenia, bring apathy, advance expertise who now, to and

in to, clinical lives, employees committed I'd physicians, and Before patients’ mission, impact I participants truly as live your thank do, a also you. our call and positive With now our this we development you, I open so making the every Sarah, do our I for I you on you. that day; that and the we to mission can thank And thank and who for always programs, couldn't say want conclude, tell without to are like that, and our to caregivers investors, support belief let's questions.

Operator

[Operator Instructions].

Michael today Yee line the of Your first is Jefferies. question Please ahead. go from from

Michael Yee

safety so how scenario that's What there? tolerability the was to Hey, of study good that on later exciting about the about scenarios? you Tony biology. had a this have debate darigabat. agree in but proof-of-concept, you anxiety. you. think is team. We Thank of a were much. is an translation I we thought think think think Appreciating, question both there out the you there that recent standpoint? standpoint you year, how think proof there, the little now efficacy and to presented know about those do all it I a data, you how efficacy for epilepsy data Thank bit And bar the wondering I I and on and morning,

Tony Coles

Michael, morning. Thanks, good and Okay.

point the the they as GABAAs with these any possible like his by benzodiazepines, prepared we achieve non-selective activation. demonstrate because see are in make it results, first remarks, αX the that to is, excited, really said to I'd without that So efficacy Ray is we

this particular αX and this being mechanism power studies seen in important both for our And really earlier a now that's sparing. and anxiety. demonstration of of clinically epilepsy the we've it's So

is comment further The study spoken other selectivity this doing I'd I'll thing trial complements both or through from are like trial, to volunteer we volunteers for in healthy be moment. of I'd the much trialing really expect than patients. duration as healthy that important we're it practice there this a this tolerability just work shorter and J.R. which all of volunteers rapid in particular to in comment think was had do or And is with validation anxiety. more from about. There a we've some discussed don't findings in either highlight healthy volunteers, And was clinical just some distinct that to specifically perhaps are common patients. would and this differences. Ray -- healthy ask to safety or important anxiety I titration differences read efficacy patients either this in in previously, the because obviously I've

and its potential opportunities, in the soon mechanism, So about and turn are we multiple Mike, J.R. to about know this additional can across really But disease over it you me think excited I any for what we'll detail. epilepsy. let sum, mean,

Michael Yee

about Specifically How out you're should just the bar. to efficacy for on whether datasets and thinking there? bar other we compare the there

Tony Coles

Mike, I'm sorry.

Would your end. second my on you up question? just half broke the repeat You of

Michael Yee

Yes.

other and out datasets drugs? be to what how for on you would other And positive, there see? it reduction bar seizure like assuming what you magnitude could that should Specifically to of the think efficacy, we just about compare for

Tony Coles

You mean specifically? epilepsy for

Michael Yee

Yes.

Tony Coles

Yes.

okay. Okay,

that of you So detail? the question answer Ray separately. provide J.R. J.R.? part We'll additional have some why don't

John Renger

that I want Sure. for referencing data that then meaningful clinical we difference Thank think, Yes, can can I to interpreted, you, trial this designed and the Mike, the and the selective to Tony. compound and the to a how Ray treatment we speak so you're epilepsy it. and that symptoms. a efficacy speak in were in read though that first is the really to this powered trial, how very that time receptor epilepsy demonstrating I in the reemphasize a think demonstrated just healthy that has in note, study even to Of we has the for being resolution that strong very the very are this in occupancies a identical the is achieve targeted it similar, through disorders. anxiety-related ones used of to fact ability panic potential we And trial.

So we in the dosage dose ranges is that in trial. know also used we've efficacy the that again that epilepsy what demonstrated are being the with used

So now the previously. this this one, study, indication efficacy in patients you also same as efficacy looking shown treating have. healthy in And we've neural dosage the the a brain this at in second those We've with of treating the symptoms different can underlie range photoepilepsy in that panic know is pathways in that demonstrated study. epilepsy feeling

indicates is want this demonstrates we we're dose what believe population either occupancy that that us So range the understand receptor that we to we that the effective to range, cover, covering in and actually activity. important that CNS

Ray? epilepsy trial we've powered there. I'll to So, let of and Ray speak actually design see the what the to

Ray Sanchez

you morning, the question. Good Michael, thank John. for you, Thank

you therapies to been To of terms Keppra other a reduction powered the know give you is some in that landscape, trial XX% the in of given they XX% So not show as frequency. epilepsy the data XX% juxtaposition selectivity and the principle but show higher trial. We're ongoing is the what hoping to also that's XX% about in the mechanism, to is in photosensitivity generated seizure proof the if at least of demonstrated. date

the in tuned in epilepsy data and population but can year, as that we've well. we're and seen the date, hoping we epilepsy encouraged anxiety by benefits later what of stay we'll this see seen that we've therapy So what to this for in

Operator

Morgan line from Matthew of is from question Harrison next The the Stanley.

Matthew Harrison

guess I have X. I

of imputing data expecting second, than on tavapadon, of be X-point original first, because have example, missing those? can for you size And in just was you So were the there? Can the on you pool you the plan? to what pull trials, us X effect that remind percentage comment sort would for how schizophrenia. XX you So potential the were assuming? you're if smaller you And mg them the trials just and delta dropouts then the to on dose in able stats

Tony Coles

of both registrational those, design don't trials why answering Ray, think terms we in would you the about that I underscoring questions. what and part you but Okay. perhaps do your can we these comments prepared how appreciate really they -- central you take of that of if

So know to of all are, and X course, of want range trials. a adequately placebo-controlled safety, we there that the is powered emraclidine. the dose characterization agency for long-term be going full They for looking

just -- we're So they'll specific FDA tav but take the speak we we've looking then right about for data for question. question don't questions size and Ray, to But evaluate pooling we right you and to think the expand of the why the be the registration. on the got possibility the for effect know asking that

Ray Sanchez

right. Right,

So good Matthew. morning,

So top dose order In of registrational effective XX mentioned of the X as well, trials know, looking nature, separate minimum before Tony milligrams at as to pivotal full in each I for as think, and to they have the range the milligrams. them know. I've be were dose to milligrams you from in really these potentially be as dose XX of nature, designed said, has and XX placebo, that or you

few and very designs. accept. done the So agency historically actually data, the the cases that combine that to They've opportunity different in populations the not approach different with trial very probably not but it's will likely

our But plan forward tuned to viability terms their registrational in at data stay that of will generate its in the in order meeting the to to FDA end-of-Phase moving potential. that the to of we not to them be registrational is we the program data X present pool for So the potential. see

know. we're about we the in asked XX% a approximately terms fares into when designed you the trial question, historical MMRM trials, We of on data, tavapadon. that mixed a second Parkinson's of repeated And model precedent disease. as going We'll using it of But approach, how actually you the The obviously measures, anticipate, trials trials in produces reads what out. that's it rate. other assumption our from based see versus imputation and once discontinuation

Operator

is Paul from The the next from question Stifel. of Matteis line

Paul Matteis

rate, are in maybe of changes separately, I or you're little are study? view you in you guess sort questions monitoring to safety why we then elderly describe? I the this? maybe likely blood that have this you to as do a can on program. you decided psychosis. plans talk I And go just it One, more Alzheimer's you the issues? do see, to Or on of about changes had maybe was if just hoping the cardiac thinking more the And doing, wondering should set like And how things changes what things be that X about could any study pressure, with that just cardiac heart sort of into sort MX labeling you talk about bit up, you

Tony Coles

to cardiac to just I take Okay, is This me pressure. -- That a question monitoring designed make let of differently. very of couple going study. comments, question, but ambulatory more Ray to the would the Paul. isn't the really quick just pressure blood ask at safety but let look appreciate a me specifically very, I'm study this heart question, narrow rate be

you did in certainly Xb, have the did out AEs what we As tolerated know, placebo. observe as we proportion time. not is, to showed we Phase And over associated of

is don't ask about the blood that cardiac want that pretty just We're safety narrow question and we a agency this and know rate. heart will pressure study. I answering the So specific notion a

any you that So comments my don't to I make you add Ray, want way why to like? in distinction, but

Ray Sanchez

Yes, yes. Tony. Thank you,

fact. or in rule understand outlined in as It's developed sustained what's pressure, Paul, very blood it's does saw blood at we the greater there and versus that end X-week for systolic that's of the ambulatory a trial X-millimeter guidance know, mentioned know. But But agency emraclidine rate trial, really so effect the XX% And that is is trial, sustained And much And X-week out pressure. baseline. Xb effects blood in powered the we a systolic Phase than in and think sustained was trial, mercury in heart why in as pressure in here pressure you I Tony to blood trial, XXXX. to you So heart of we increases that to as interest the a increase our really ABPM not the encouraged monitoring over an a conducting what really is where negligible the sustained placebo. were of pressure that's blood really were rate. effect

pressure greater effects rule get I They sustained out week baseline. So And blood recorded XX-hour recorded to X at of get of are the a then at monitoring. than patients the X And powered, mercury. mentioned, at as it's millimeters evaluated. course,

So better have as that's -- per characterize the in we And at do to Phase again, results understand have guidance study the don't something being Xb on the to it's the and and per any and but to FDA that order trying what based we weeks, were well. But elucidate. effect, X weeks at concerns. X we

Tony Coles

only this only instituted The the the in or there, X point for blood last years, pressure recently X FDA monitoring is Yes. studies. underscore Ray, ambulatory say, guidance, that I'll

package know, to our I So psychosis. about any is you a have Paul, dementia-related situation in the that part registration question do. of asked company this would

J.R., of then is of should we think, A.C., responsibility rationale would the has through. President, take if available who to mechanistic you that why clear first answer the you don't half our second for that? part there's I commercial, a go And because Abraham, that take questions.

John Renger

you, morning, Sure. the Thank Tony. thanks question. for Good Paul,

so yes, So absolutely.

completely there's and work the in that psychosis. we mechanism fully appreciate MX a for potential to So dementia-related

showed an As you actually was done the AD of a one symptoms population. an in completed psychotic studies treating that population actually xanomeline well the benefit was AD first in know, and in with

that As however, because of of tolerability you somewhat was the interpretation dropout compounded, the high because rate know, study of the issues.

indication. with they appropriate is really saw do the believe emraclidine there that we validated our very that way selectivity effect to dose-responsive approach muscarinic we that which potentially an MX approach the and with so refine that And and promising demonstrated

of but and here thoughtfully I that also population. focused an after range to But that emphasize the in treat to the approach and very to proceed safety forward demonstrate pathway about approach that, psychotic the we aware there. we're best on the do establish carefully the the safety we tolerability the take profile really and of as to what muscarinic to the want approach we want fully go so we'd and is dose have And range, symptoms using understand then appropriate And profile. tolerability want is to a believe is absolutely what most that because in dose replicating to validated what and like clinically of we efficient have compound, way we think so elderly to frail the that population

that. in actively absolutely don't with So line And what like take your if pursuing question the to. getting second Abe, would know part. you I over to we're is

Tony Coles

take half speaker morning, this it. that let J.R., a second of informed doesn't Abe Actually, so me line been just I've the have

I great the patients bring can we see all potential the think that elderly potential and with we emraclidine. benefit to

I debilitating, handle to dementia new million is as XX has it requirements which the it's utmost suffer have to that path sort year. of this a registration. work safety think forward with who profile us from do the cases schizophrenia a this through And for will dose on the in urgency population, globally, and every elderly range people made And quite figure so we that making and we for good both is ensuring about is that be ongoing. the the the point XX -- million

it's figure So to us this out. very will we important and

Operator

H.C. Wainwright. is the from Douglas The question Tsao next line from of

Douglas Tsao

So curious. I just was emraclidine, first, on

for for schizophrenia question a is in Xb prioritizing advancing study, my be to I if about you going population sort further, ability or an of advancing enriching assets or I'm have greater standpoint. was certain versus think just -- curious also, shown into you've of utility new second indications drugs the prioritizing into that sort Phase population maybe you picture the have expanding thinking indications. the effect symptoms. patient specific study. ones certain X certain assets terms achieve for individual then versus to effect types the broad then tuning potentially or of new from the follow-up, in which indications? related And enriched new guess are of for you're big And which How them to I do,

Tony Coles

I'll you second. Doug. enrichment. the could question about Ray, Great, for Thank the take emraclidine And you population question. the if answer

Ray Sanchez

Tony. you, Thank

that drug that do we the patient be So enrich make with Xb could population the the this but we what was -- that one in population did had that Phase we we more all actually profile sensitive the signal. a per to didn't do like trials, bit detect severe. by our did And making se, was the a -- trial, sure patient we is sure that that

actually in by PANSS the symptoms on positive that certain of a subscale threshold So the did it down met of role. breaking played severity a individual positive in And also terms they scores. we then that terms the score, symptoms,

trials Xb that's the in patient all I So is be was that's approach across refining not per enrichment also and as program but Phase regardless se the X will would our approach something but say population, well. population the our of in critical what

Tony Coles

important think just the half contextual which make of question, of Yes. one, your And let then about Doug, I prioritization, me is really asset couple second points. a a

of to do. First ours like the and to need to our place different tradeoffs of And figure to a to capability dollar. have all, portfolio, assess opportunities built the try to an portfolio kind do next internal out that analyze we've that companies

well well the clearly much for are a we're also in integrate very really alive decision-making is capitalized. cash comment position and that strategic strong function I'll So organization. guiding and and that the -- that

I'd balance. we operating been really that formation had previously. year-ending cash on Mark's over from not have our following driven opportunities, these were is heard You've some the that the fully When by are plans Cerevel report the at we we Pfizer, And And say. exploited took of particular science. what a there that great new current anxiety is example, realized programs

know we'll prioritize. of MX allosteric and richness also have our sense. a an and telling We've how we to that deepen instance, number we -- for to really the be asset, muscarinic or thinking the we'll this. given trying the we science is as that pursue have, those trials of we the what there track agents really portfolio makes the careful same the But program that really our extensive, build not opportunities about that multiple modulators. got additional to us the and think To is we only of think record about that our designing for I indication are pay and attention with extent opportunities franchise, pipeline very if So and

capitalized. dollars. the will behalf we well of importantly, strong analytic on love well-integrated approach the we've And I the love how got a benefit of So just so fact we're very do really we fact science invest I that and that patients. the portfolio the and follow to

Operator

next from Kumar Madhu line is Sachs. of The the question from Goldman

Omari Baruti

This is on for Omari Madhu.

schizophrenia how first, and of in product you think the studies profile? pivotal compared initial So to tolerability efficacy in long-term about studies do in terms

Tony Coles

because one than Okay. take you have more do question we'll please. And both together,

Omari Baruti

then REALIZE And the us you walk can epilepsy? second expectations just Sure. are for in -- in through darigabat question what is

Tony Coles

Sure. Okay.

just want the on got first think I to -- question. the make sure I I

emraclidine what we currently other I agents. asking versus see available differentiation for potential about think the or as you're therapies

of So potential I'll about ask first question tolerability what and think profile, Ray to talk efficacy believe I also was. is your the through the we which what mechanistically

clarify and So you make around take would one, the be question that Ray, come that sure back answering And if just to it. we'll would terrific. then darigabat we're

Ray Sanchez

Sure.

question. the for you thank So

-- the for need have with malignant a patients novel be know, effect you other side quite profile that agonists is don't for that antagonist population As can DX that great schizophrenia. schizophrenia there the in than the is partial or therapies

PANSS we an But profile here that very agent very have our a close has a to points. who robust shown -- total of tolerability in score XX actually favorable with Phase Xb so to trial reductions And date. also

that's the encouraging, has something relatively opportunity exciting benign compared -- available And it is profile provide gives very also and a us to the that only on that tolerability is therapy because excites an that's but what's so safety profile with that not landscape. us efficacy very

difference, see show placebo-adjusted a acute as robust of this hopefully powered what's expect accordingly least more historically, doing, trials of the later at but outcome. know, that's are really we landscape we shown term, terms year. on to we In to the X-point a and starting based them your And acute and been long versus question you

tolerability immediate agency the will a treatment maintenance understand X In likely package. that the really from any is ascertain know. extension, But a in longer-term months the as that longer show The long-term safety and it's to longer-term I term by commitment open-label efficacy effect. collect Phase most for terms something not really you of to be we to be you difficult be subsequent the it's that and would at X year. mentioned an approach. data you including extension, But very NDA X effects, as us more think and to agency open-label the in something know, will would require It required as that

transformative our So to for this therapy that's the excited be and about how the approach, and it we're will potential landscape.

Tony Coles

And what Ray, second thank Omari, might we do Omari's epilepsy to that Phase X the extend we with powered Xa to in you. consider how we study. then XX% difference study. epilepsy just what darigabat the photosensitivity and please. had on saw I But study, in the And Phase of I hoping touch the Ray, Obviously, if really question think success the think, half we're from mind, don't you the

Ray Sanchez

Right.

So a that the that about even the you seizure data question was actually could seizure the reduction. an often. to has be seeing as what earlier XX% to know, in suggested see more detect reduction it's XX% hoping that photoepilepsy you with powered it mentioned trial been We're Keppra with date a quite in that robust. trial I we've XX% used

terms performs of And powered benefit the we'll so more that in than for. greater population. in epilepsy have can we obviously, what we But see we're hopeful darigabat even this focal year, clarity later how

Operator

line the is The last Kasimov of question JPMorgan. Cory from from

Tiffany Sun

on Tiffany for Cory. is This

we data midyear. that lot questions got of Karuna’s X a one readout Phase thinking on about might how investor you Just be

to it’s obviously, But Is there? to And to thoughts emraclidine the this potentially some for provide database feedback gating be it could read-through similar to then that, a thinking OLE required positive any a in factor just effective. or and initial follow-up OLE? as filing? market the just about safety anticipated research So the

Tony Coles

Okay.

market, said epilepsy milestone, a next really our make which that's data once-daily focused of of the think there I'll side couple pathway the the is move that most we really plenty for important and certainly new we're make multiple players for including a administration, we confirm couple Phase the to is titration. I features an are Having know inforce of rooting the quick great effects, that do as company. to antipsychotic Clearly, important muscarinic Obviously, need room. interesting, X we've we're lot innovation a exciting are unmet support but there We in both catalyst selective the has what need. is be certainly space in going for to that features comments. some mechanism. an program. program. a the leverage derivate And we times, deep of our as the plenty belief approach, potential And the where and particularly clinical as the no all on those There's on of Karuna have reduced for room that, question, Karuna's hope there's said GI of success important

can to we're and profile where emraclidine focused at So clearly, differentiating success we for believe document But patients, got a strong it moment. wonderful that's add the that would if with anywhere got be new we've therapies. and reason we've

taking The that second looking just question there? one for about the you Ray, and what do we're OLE. mind

Ray Sanchez

Sure.

is the needed correct, you open-label for So are registration. extension

at to year. XXX X exposed at and have patients X least at X at have patients We least, months

we're from but an also only adding patients exposures. not is over approach be novo approach those the pivotal to trials, de have for course, Our numbers, always of to for And sites using where FDA. exceed we're going we roll additional the

file we And so NDA. us the that by we will the need the get exposures time

is of thought critical And open-label the not that's extension. terms the course, be. it rate in our path, become will always so limiting, something that doesn't we've that, about, it So of hope

be so And data reads both that data are this CMC and see we'll get that X work and indeed, our other all Phase to to But will wait trials forth once and patients sooner to we medicine later. all how so and the positive, have to that have the will If -- preclinical we're other try out. necessary. than transpires

Tony Coles

Thank you for question. you, Ray. And Tiffany, that thank

great a with second year close talked guys, in that's data. it We'll really that anxiety half the think us. wrap I joining us. we've year going -- in for about. with with the the start the strong We're off for the to to data epilepsy Thank you,

So sheet strong. of important The a drivers The lot really balance value and coming in team up subsequent years. both strong. is is this year

continue appreciate you to we've given are I we've this the think how And I about landscape. So guys great morning, to results. conversation deliver we elements the our in got to right think about perspective change confident the ability we all good

guys So for have thank you a day. joining, good and

Operator

conference you does That Thank for for today. the may participating, conclude now you. Thank and you disconnect.

Cerevel Therapeutics (CERE) 1 Mar 222021 Q4 Earnings call transcript