CERE - Earnings call transcript Q3 2021 | Cerevel Therapeutics Holdings Inc

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Operator

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

Matthew Calistri

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

Tony Coles

redeemed That we this positive offering our company. $XXX results trial our the from third of CVL-XXX, Phase top or premier follow-on schizophrenia. you we major for compelling MX-selective Thanks, Matt, and line aspiration morning, warrants. part good secured quarter, joining becoming outstanding realizing million step public of announced modulator in our our early our toward us. data of PAM and neuroscience of Xb Earlier allosteric In represented Thank first year, the everyone. the

for development CVL-XXX. equipped we're programs data and month, the many two CVL-XXX, to to R&D are bring while in the all and with apathy, and selectivity subtype held capital in rapidly benefit, possible. we our of neurocircuitry event Last portfolio, much broad a agonist to well dementia-related our released leverage for on the programs where Now, virtual a DX/DX execute the additional drive of which and needed as understanding medicines we patients our people, therapeutic as momentum effects. side These partial of receptor minimizing deep just discussed

And broad details Specifically, moment. program of Phase by X. of mid we provide quarter shared a the R&D review year. are program a again few and will late of on CVL-XXXrapidly in into to next during just weeks development the timing ago, outlines We our Ray which first advancing our additional design event we'll that

the And our our our Phase the two Phase our readout of epilepsy half by the also in the to end in additional the face for And darigabat the expect readout we from trial data of X We year. of apathy. anxiety tavapadon for from early program with and we expected in XXXX, focal X data now quarter late-stage course, in in XXXX, We data in Phase XXXX, to readouts of second next X XXXX. of the pipeline. Also half across Parkinson's. readouts years other in from programs anticipate data first few expect CVL-XXX acute in trial, second expect of dementia-related

development, pipeline, a disorder. disorder for including programs multiple have stage use we addition, depressive substance In and in robust early major

identify to drug Cambridge new the have some of with capabilities we discovery state Crossing art at brand and intend our targets, potential. disease modifying neuroscience also new facility, including laboratories We where

a that important With well pipeline of of spans and development, deliver to positioned depth we're a catalysts stages of beyond. in number all the XXXX, XXXX

Now, provide latest clinical Ray? our Ray on to Medical the ask our development efforts. let Officer updates Chief Dr. me Sanchez,

Ray Sanchez

meaningful Phase significant group I'll milligrams morning Thank June absolute XX starting once antipsychotic good statistically serious of gain titration points, In In development CVL-XXX meaningful effects XX receive an no clinically you, we XX while from milligram selective need commonly daily stage drive effects, oral for improvement to in is all approved positive our with in twice for muscarinic improvement in cohort are this treatment and this effects, Tony. of and/or of GI extrapyramidal And PANSS without year, the trial, you. doses targeting total score. demonstrated daily enrolled our akathisia demonstrated placebo. randomized this reviewing milligrams released placebo. subjects other X:XXX muscarinic milligram gastrointestinal agents. CVL-XXX for baseline on symptoms versus or top differences believe CVL-XXX. weight The receptors. a be and avoiding once the that we schizophrenia. MXover qDay [ph] CVL-XXX of XX.X with anti XX extrapyramidal, highly is points enables daily metabolic Xb or showed that agents side to antipsychotic XX.X the We an or medication compared of selective observed effect one Today BID of CVL-XXX of data side with a of as CVL-XXX the Both to ratio to while late programs, non-selective with line psychotic trial XX designed

baseline and point reductions into previously shown a groups have this or historically medications treatment to to approved In context, XX XX point had addition, on basis. XX to or improvement greater put relative significant adjusted relative XX.X placebo, a To statistically X to placebo XX.X, respectively. of a both improvement

were adverse from and very similar across were Our subscales, negative tolerability effects, were encouraging. weight supported trial Treatment also associated as positive all CVL-XXX was extrapyramidal emerging and arms, results rates gastrointestinal AEs three of with low rates by as side not The gain. PANSS this very in improvements event observed. akathisia were or meaningful CGIS. the and trial the further safety well clinically PANSS data

Importantly, there gastrointestinal or were effects. side discontinuations related to cardiovascular no

elevations As observed were the modest which not expected, asymptomatic significant. rate treatment with in pressure CVL-XXX heart weeks clinically six and over attenuated and we blood of

continue to rate monitor pressure Phase We and blood will heart in our program. X

of CVL-XXXinto activity Given plan are profile receptor steps for data, the be once the once additional the presented Meeting observed At of include the favorable strong we dosing occupancy the daily trial, the the essential X daily regimen Annual data for without tolerability present Xb the XX anti-psychotic titration R&D seen next our data - we Phase in and that are results event We X demonstrated October we American CVL-XXX. development advancing Phase pursuing on and advising on informing treatment Phase our PET December. impressive rapidly PK/PD our at which Xth, schizophrenia. Based in pharmacokinetic new to to trial. the today, have Phase doses College of Neuropsychopharmacology will in doses program. milligram in The will we selected Xb to

baseline B our similar a to which on development Xb primary PANSS profile for the to one includes Part trial, will Phase established explore design six Phase or Xb more trials fully score. of weeks plan Our powered patient the for of inpatient change placebo a endpoint The and follow and CVL-XXX. treatment, trial drug range precedent adequately dose controlled total from schizophrenia, of includes

in for trial, GABAA in Phase our next continues end We extension expected receptor have Cerevel focal the that and to quarter We this acute and a this more our allosteric well how by studied year. of looking second in anxiety. trial the placebo be advance X, mid the in trial being first Phase to as in data alpha-X/X/X the epilepsy proof also randomized positive Those in details will positive known darigabat, its we controlled to [ph] readout forward first We're next of or full trial proof healthy be is volunteers. for are compound providing by we focal modulator the concept of currently Phase X as next epilepsy, or of inform principle open-label XXXX. global anxiety year. Data related dosing will darigabat to now of results of trial. say expect for The some PAM half the X program late data indications. can Darigabat corresponding selective one quarter of REALIZE in as expected

programs, tavapadon Now run program stage nicely. to out disease the discussion our our of late TEMPO Phase global progressing is in Parkinson's data X for

in the Phase of three trials, X TEMPO-X Parkinson's, and all X Parkinson's. in in and dose early-stage TEMPO-X late-stage to continue We

we dosing patients label In and TEMPO-X, extension in trial. novo XX open de our are rollover addition, week both

XXXX. of data and second the expect first We X X in from from TEMPOs half and the half data in XXXX TEMPO-X of

updates I to I've on our like pipeline. turn of over that John the Dr. lead John? updates will our Now, to provide clinical three reviewed our Science Chief the programs, rest Renger, it Officer to to

John Renger

Thank morning, you, Ray. Good everyone.

our partial month, discussed of condition event dementia treatment related associated apathy. the comorbidities dementias the X our a neuropsychiatric in CVL-XXX, without most approved and common option. DX/DX is R&D currently receptor treatment devastating Apathy dopamine agonist During we last development with for remains Phase among a

trial daily, weeks Xa treatment. randomized of Our milligrams, X to XX once and designed CVL-XXX, two placebo X of subject is XX over test to Phase doses relative milligram

appropriate apathy overall of measures CVL-XXX. to We patients changes the will the of assessing metric most this potential And range for fit purpose be condition. established determine evaluate at to in a to therapeutic understand

and June, for results patient dementia half year. We we In in trial, Designation and potential in We're this clinical the rolling the the CVL-XXX we more which indication. the with best available NDA the to has forward now for for have anticipate dosed Fast treatment the with apathy, and determining received in Track the of of as this second novel related FDA, next in submission eligibility developing first be priority to in a forward treatment agency well early enable review. to interactions path closely as looking interacting frequent

world of review I'll come. novel quarter. Bodenrader, Financial to leveraging And Officer our of and performance engine Chief progress. small programs In use many turn inhibitors Receptor keeping disorder building for CVL-XXX, over now stage believe pipeline differentiated addition, Cambridge CVL-XXX, discovery substance of We're Opioid earlier neurocircuitry labs research advancing third number molecules. development depressive develop Interim of a financial clinical a highly to of DX ongoing, our on treatment updated preferring our selective explore out discovery to Mark? PDEX CVL-XXX, programs, disorder years we're it MDD or at our opioid engine research ongoing receptor and and stage regenerative multiple feel With antagonists chemistry our to in development we're will use in for in for for for Crossing. major robust potential also a this MDD. and or you schizophrenia looking our therapeutics sophisticated and We we're drug Kappa the class disorder, our Antagonist to forward Mark the dopamine understanding including

Mark Bodenrader

Thank John. the joining everyone. thank morning's you call. for today's full financial morning, Please Good for refer our details of release And to press update. you, this

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

expense, expected, build the an quarters, primarily stage and expenses $X $X.X we increase over R&D by G&A Relative third the million million grow was which of quarter driven - in also Crossing, R&D third included increase our by approximately company up last infrastructure quarter the driven third is third in trials, primarily the increased laboratories as our out to costs expense operating last clinical of This spending progress in support our relative of $XX year, relative prior grew of programs, equity business. costs expense as advancement compensation As pipeline. the our to increase we for total to Cambridge to for early ramp based the the quarter for million. an leading higher year. public quarter the our by

included in versus We expect million the million the increase expense same million to expense to advance compared year. expense year. G&A based $XX R&D equity clinical for quarter as our period for $X.X prior the the approximately $X.X third also million, expenses for of quarter compensation the to continue third third G&A quarter programs. we $XX last was for

infrastructure. support the to continue we expect the our public as of company G&A to We increase progression company including programs the in the expense over our growth R&D of coming quarters,

fund redemption a prepared cash As proceeds million our and And initiatives. XXXX. equivalents pursuing next Tony of to advance on cash our from call our multiple $XXX includes our turn current expected will with which stage operations balance XXth, now the we're to also remarks. drug and With over our warrants. into from concluding in in three while follow received I strong programs cash we darigabat, tavapadon, position were and to offering programs, our clinical earlier the value discovery years, our to CVL-XXX, continue July, creation exercise lead the for September sheet expect proceeds over opportunities including and position, public

Tony Coles

Thanks, broad see, is of will premier hope our we're Neuroscience pipeline, the and what we at and Mark. great can neuroscience forefront. is we Cerevel advancing frontier Well, the next as you become know company. building the medicine

appreciation and We we want And want the expect the your employees data of I of next the the clinical our few for to the excited have hard multiple and for pipeline Thank open our do caregivers. these this not lives to thank deep we to the contribution important and certainly you all participants do could With your us their in that medicines. in to potential operator, are years investigators what without without continued development of readouts my we also transform devotion your patients trials we and for about much floor needed whom now passion, joining work. can in who, express your morning. I for questions. our

Operator

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

line open. is Your

Unidentified Analyst

report? are And Hi. be taking data you would you probably a remarks, Phase [ph] the more that the This as think first a Thanks [ph] X anxiety that color the anxiety promising context interesting on emphasized to you'll presenting what with you Thank What J&Js assumptions? prior was quarter, design, I planning follow in you. put thought a powering which give be considered for Ben trial? And in upcoming and is up, question. bit data for an Mike. comment. can into some you little the I data? in on please prepared Can

Tony Coles

question. the for - question. don't don't you Sure. why that you why Thank you Ray, take

Ray Sanchez

Thank you that question. for you, Thank Tony.

of know, darigabat the understand quarter. symptoms. to have the of to So will trial to drugs we potential that sensitive the that hope our is dioxide carbon and as you that's [ph] readout panic model in be treating been a this delivering the using is signal by are the model challenge inhalation use This end including of treat used SSRIs we And of data first benzodiazepine our anxiety disorders, been the

healthy crossover for trial It's As day a design a a inhibitor used this also that three that conducted Research being you extended period, that volunteers conducted sequence in is Centre orexin X Drug in two also know, a the was that day, day, XX and the the is - Netherlands. milligrams a in looks by milligrams it's of cohorts reason was well. program And has is at the Human the two and XX arm in as including one for treatment alprazolam, J&J. alprazolam milligrams

two give placebo [indiscernible] will has adjusted the a on on been three alprazolam trial the to we better the it to outcome traditionally, opportunity a juxtapose fare placebo So scale, clinically showed us how understand and really the X.X adjusted an symptoms difference. data which checklist, panic meaningful and points,

use we population in collective familiar our the who advisors in anxiety. to next on our will a this with are decision this with working So design steps make approach, treating this information

Tony Coles

next Thanks, Ray. everyone it instead of And first year. the top to we half line first of I'm our But guidance the sure in bringing are data quarter for here. did

So stay tuned.

Operator, off We question. take data expect Thank next you, here to have we'll very Ray. some shortly. the

Operator

next with Paul Our Stifel. comes from question Matteis

is line Your open.

Paul Matteis

so kind remind if of just powering of was the darigabat, selectivity without the A taking this about sort wondering good that us can study bad. couple and hypothesis this well. you could taking much Great, then a kind is thanks step hope with the class sort as on of questions. of for right, I in the the you of - [indiscernible] give separately alpha-X back of the the

So And tolerance the what or evidence in trial out Thanks in in expecting so of this of alphaX-X the the specifically much. rates, selectivity cut comparator withdrawal? you hypothesis. study as are of see from clearest this things see sedation of sort to do prove kind avenues arm like to terms what you

Tony Coles

And might about Paul. little before. a be talk - that Ray, that the of for. efficacious. if the set Thank Jay I thanks. answer this if mechanistic effect actually piece. bit we the selectivity side question, gone Okay, you, the through But context think rationale I for then know you you take selective profile be this expected just trial, then let's alpha-X if we'd would your have darigabat and would about [ph], powering questions the looking Paul's

Jay. So first mechanism, of the

Unidentified Company Representative

vocal so the to able Tony. from is sparing you, the know, question, and Phase more Yeah, looking epilepsy to that that look appropriate at alpha-X as to that thanks in having alpha Thank underlie both is in Sure. that that's for And we're hear inhibition design. for the trial an study. X remember, why the part you neurocircuits compound Good Paul. a enhance of And of you. epilepsy, tolerance. you may XXX intent onset And as be study to is

believe we that we you in we you as the know the to will the don't alpha-X the have alpha-X directed sedation seen show so allow in circuits us underlie know, expressed that brain piece, And is Also, sedation. that tolerance so with mentioned, that alpha-X compounds. as sparing

been in see clinical able so avoiding occupancies, to setting, And have receptor by sedation. that, very not go and high the we actually to including

when moderate occupancy. but that are receptor what of plays side a you dose [ph] Benzo underlies And do in is use, that even is to in common we that panic seen XXX limiting which effects circuitry the that levels avoid what time, sedation anxiety, very seeing so role want the demonstrate that to dose that

control can of comparing levels see motor sedation. even So you and receptor XX% occupancy,

have avoid cognitive, with benefit, the panic that means. do to what non-selected commonly of we [ph] to seen as And want coordination, or any ability demonstrate sedating effects that the motor is so are the it visit

back Tony. that, it with turn so to I'll And

Tony Coles

just any before was of the take talk you that a part little power and the make? relative I question of would one you'd Ray, the about bit Ray, of clinical to question, study the if commentary like Paul's

Ray Sanchez

Right, right.

of John got duration design. issues really you in It's to But for readily XX then, is treatment this of Symptoms alpha-X. by just Panic small, be not of differences, that shows, confidence what in Because the relative healthy some milligrams day. fairly are or side trial top look the cohort. course, as of that we on do Paul, that adverse milligrams want is dose a what of see the just cohorts is and show short, the any it's withdrawal, so Checklist volunteers nature not intervals of we'll minimum powered XX that proof to up each is of that evaluated, So course, know, articulated, life principle a in at, the the effective and the of pop placebo driven will and looking of as alprazolam know, the to you like. the is given tolerance dose XX the three the usually events, some difference which effects - And the like

things the to we understand also is want that sedation versus of One somnolence.

but have minority seen quite not of in we've different seen historically, some are and differently. know, two labeled you the quite know, are As the we with sedation, you participants somnolence darigabat,

and darigabat. in looking the for the the appraisal versus group that groups treatment we'll other treatment be [ph] also So other,

Paul Matteis

detailed for much so answer. the thanks Great,

Ray Sanchez

you, Paul. Thank

Tony Coles

Thanks you, Thank the Operator, we'll questions. for next the take Paul. question.

Operator

the remarks. for other no queue. to back turn in questions like I'd to any Tony closing are There

Tony Coles

progress. earlier and both eventful We're across us the results. with very and and been for a the a we It's bringing as day updates you should an given some months today. XXX very Okay. data certainly Well, call, look year see, Enjoy thank the happy Take you the into the making guys, got. to capital this as pipeline joining year of announcement progress entire company through Thanks be well, year. a further and XXXX just the as care. raise important and great of for the year, quarter productive forward morning. We've us got team, readouts weeks for we've can today's the and joining terrific your

Operator

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

You now disconnect. may

Cerevel Therapeutics (CERE) 10 Nov 212021 Q3 Earnings call transcript