CERE - Earnings call transcript Q2 2021 | Cerevel Therapeutics Holdings Inc

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Operator

Good morning. Welcome to the Cerevel Therapeutics Second 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 questions during the Q&A portion of the call. Please note that this call maybe recorded. the to hand now will call Mr. over I Corporate Investor Relations. Calistri, Vice and of President Matthew Strategy

Matthew Calistri

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

Tony Coles

for you joining everyone. Matt, Thanks, morning, and good Thank us.

patients in aspirations We become to earlier one believe topline improve in quarter. this to In for more and positive the lives were results review the of for and encouraging, potential Medical Phase our in MX-selective deliver of been The the the premier and trial Chief a on Dr. therapy compound as will Cerevel quarter millions PAM company. our pivotal the truly results we CVL-XXX, a Officer, has transform moment, data were announce Sanchez robust schizophrenia schizophrenia and has their Xb very we Ray to pleased neuroscience began detail. to our caregivers. This

fund stage need most proud proceeds readout follow-on will more $XXX now recent X Together strengthened public a the data used offering and balance million several our raise company. for tavapadon with outstanding $XXX of advance positive of for over be completed than continued creative and including next a CVL-XXX, our proceeds. programs. in our our to we we With the have to we're risk $XXX have our and sheet capital this deal to program resources a our we the years. approximately have from through warrants, earlier public advance redemption our total of Following sharing million focus proceeds on the The readouts as CVL-XXX public of pipeline warrants, redemption with data of comprehensive formation, three have our raised Phase to multiple million net

for late-stage Darigabat early expected half. for readout data for X Phase designation from expect data Phase we epilepsy anxiety half from first and second acute X And readouts in in focal in data in two XXXX CVL-XXX from apathy, trial readout tavapadon our which trial Track in a recently FDA. the anticipate of we Specifically, the of in X our Phase the Phase of Fast the dementia-related we Parkinson's. and half second the asset with in received XXXX, X we expect from year an the program XXXX, our Also

months a be we'll timing provide design and additional details in advancing we'll comprehensive the I as and Phase on program Finally, CVL-XXX mentioned, into X ahead.

late-stage pipeline to rich you So number have as those and they sharing we look potential pipeline. poised as XXXX, in results that you to earlier our stage progress available. and we deliver of become forward XXXX a is also great a showing in with catalysts can see, We're

During this submission quarter, Kappa submitted we PDEX And for the fourth Opioid IND quarter in our CVL-XXX, our CVL-OXX, anticipate another for an antagonist. the inhibitor we second selective IND year. of

I'd we most our Cambridge Chief artificial Medical identify as Dr. technologies continue Officer to targets Ray impactful capabilities, As our editing latest Sanchez, now Ray? provide to on development efforts. drug enhance we new our enabling clinical discovery to ask neuroscience updates the facility and at for gene Crossing such leverage diseases. to the our like intelligence

Ray Sanchez

to and positive side you, highly a MX-selective allosteric is for We few to akathisia muscarinic recent in PAM like spending serious Phase CVL-XXX antipsychotic reviewing or effects the with minutes you. commonly CVL-XXX all and/or are to as data enables targeting effect MX once-daily drive I'd of avoiding agents non-selective that this our selective modulator CVL-XXX, Thank selective over schizophrenia. metabolic good GI extrapyramidal, other morning for designed that receptors. a is approved medication agents. oral Tony, muscarinic believe start by observed while Xb and antipsychotic

point side As B, The placebo-controlled designed a in evaluating in of symptoms profiles ascending addition doses respectively. both were and subscale A p-value with XX detect the of in pharmacodynamic total informed absolute with evaluate results in a placebo up milligram groups observed effect on meaningful treatment was milligrams These the doses. PANSS the The XX PANSS that the with which of meaningful improvement was six the The of six reminder, XX over further baseline reductions the score. improvement for score. while an XX.X different negative gain XX% PANSS over XX of effects, a The twice-daily of milligram significant versus B of significant showed a or milligram the two to improvement to tolerability twice-daily X.X significant Part the doses. X.X treatment over double-blind given to was points, compared XX group for placebo. And X-point to dose of pharmacokinetic antipsychotic remarkable truly in XX.X an trends safety the Phase and weeks Part Both and p-value clinically from safety by group after was of results both extrapyramidal effects supported group doses relative had demonstrated placebo, and treatment in only of antipsychotic A improvements potential and powered tolerability compound a cohort points clinically designed statistically Part multiple the assessment weeks the statistically showed point placebo XX.X milligram placebo trial statistically X.XXX. twice-daily. of a selection demonstrated points, meaningful antipsychotic weight with to CVL-XXX two XX.X a of improvement of Xb parts. X.XXX and differences trial total was once-daily the show on gastrointestinal to resulted no Part once-daily

the group We for demonstrating points statistically clinically improvements meaningful both a versus subscale also of observed placebo. XX significant PANSS X.X milligram on positive reduction once-daily doses with

statistically the dose Treatment While CVL-XXX twice-daily were all at versus meaningful placebo consistent the clinically showing and there of in clinically were CGIS a meaningful and also on and Coding was and milligram Cognition two-day changes X.X metrics no the of With well other across trial. Symbol adverse were differences rates achieving very XX were three significant similar tolerated emergent in observed. with to XX cohort Test the Week with milligrams overall outcome. low a gastrointestinal meaningful Assessment X events tolerability, AEs arms respect safety Schizophrenia clinically in of improvement Brief

three the the had pre-specified active only events Importantly, few placebo not group, XX of thresholds, observed a asymptomatic and or gain. CVL-XXX reaching associated groups. were including was associated the with patients presentation. clinically six weight treatment were in in extrapyramidal and -- with changes effects, side today's These reported be subjects details on can other in akathisia significant with or No the accompanying found cardiovascular Cardiovascular AEs three AEs. Page

differences X relative asymptomatic minute Week hours and blood cardiovascular increase hours dose. we and milligram measured X.X were expected, for blood two morning XX XX. with to pressure rate heart respectively systolic was increases as the compared modest of in twice-daily increases which significant. post X.X see average dose. effects course the are at the dose milligram of were treatment. Heart with CVL-XXX dose the and relative beats placebo, placebo All and As and X.X on millimeters XX did twice-daily over mercury the There doses described meaningful diastolic XX pressure X, once-daily in placebo not blood and attenuated Page as the were once-daily at six-week no were measured These post to increases elevations also pressure Week Week with respectively, XX milligram At X.X milligram rate morning two per X. clinically

for We are tolerability safety highly the and encouraged profile by CVL-XXX.

the activity antipsychotic of schizophrenia. we're Given strong CVL-XXX the development into eager advance Phase for observed, treatment to very X

bring We the We're important for mechanism exploring also Tony is and as avenue to the we our psychosis. we development mentioned, this CVL-XXX believe of regarding as step be thoughtful This execution as MX psychosis. an in and has taking plan are dementia-related of a CVL-XXX to a evaluate potential and rapidly to the possible. pipeline, other transformative and approach next to as populations, the every potential of treatment the in deliberate therapy market steps such

of anxiety study treatments molecule in of carbon a well-established healthy symptoms both benzodiazepines in for GABAA utilizes treatments Darigabat Darigabat in depression trigger clinical be of it has in a inhalation Acute acute was major naturally as will proof-of-principle their to placebo action. with used panic advancement a PAM sensitive evaluate currently alpha-X/X/X-selective mechanisms shown well attack can occurring Recently, Hypercapnia support is pharmacological to of trial resemble studied as dioxide randomized This by XX% acute emerging proof-of-principle readout acute SSRIs development emotional potential data by of patients Orexin-X or a a & volunteers. Phase anxiety. carbon dioxide Johnson response new Johnson to distress. expected and drugs in healthy a disorder anxious antagonist used reliably X including for panic next the to This trial the that disorder, with transient into been to treat as with inhalation and model Our Darigabat, be and receptor positive novel our and controlled being anxiety. model range receptor volunteers.

assess a XX design extended cohorts milligram of trial anxiolytic three doses BID a to doses low The designed X positive of X.X two-period, comparing two-sequence carefully placebo. BID administered the alprazolam treatment is trial activity is hypercapnia control of and high Darigabat Darigabat days. a versus BID, milligrams two at of over release milligram ongoing eight with Our crossover dose

to is related in who National Dutch one symptoms COVID-XX be in primary trial single inhalation young at at the this randomization. the checklist arm Dutch the CHDR, is found Netherlands, COX for individuals which Drug being specialized pandemic. Importantly, for due of recruitment build effects and the affected and each reimposed two have will un-vaccinated conducted This uniquely is by for In anxiogenic government Research a to Human a trial to The timelines assigned Participants therefore, and the site impacted of to in be is Center change rising screening restrictions July, cohort Delta which will the cases score. placebo. active or ongoing the for authorities trial. are adults, Regulations to only variant an in panic be sequences randomly sensitive to exposed eligible endpoint

and the compound Dutch ongoing inform we first results acute anxiety actively now data the authorities. in related continue in this the to more indications. guidance The or anxiety we'll trial remains this closely from how advance COVID-XX While XXXX the recruiting, and half monitor from one will of we evolving trial expect

in in continues Darigabat our open our XXXX. REALIZE X readout known epilepsy, trial. also Parkinson's We to expected second Meanwhile, Data in X global the tavapadon extension trial dosing ongoing. as as epilepsy are trial label its to be in for disease proof-of-concept as Phase in focal the well is program global of Phase now half corresponding focal TEMPO

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

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

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

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

John Renger

Good Thank everyone. you, morning, Ray.

Phase in by the which begin everyone Let's X our agonist on apathy. dementia-related CVL-XXX, is updating partial treatment for development DX/DX of

with currently As you remains devastating comorbidities is option. recall, most among common will apathy the neuropsychiatric condition dementias associated treatment and approved without a a

for strong to expressed announced significant Fast the and condition Track granted FDA in a interest treatment interacting in treatment the dementia next the with the agency results the but opportunity enable as as CVL-XXX we patients. is year need, us forward dementia-related best June available have the our XXXX. of as half FDA designation potential bringing in NDA. for to development apathy more we work novel, for for second of looking with to this indication This unmet screening of anticipate apathy. and on the In a apathy. trial, year, a We of clinical seriousness strategy particularly for that we in agency Phase trials of the This are impactful exciting early we the and begun to the well patient indication. exploratory this determining closely FDA Based of for the in rolling a Given the more has our were this novel be option of closely potential forward for designation Xa by development the has trial treatment dementia-related clinical a in priority in this frequent interactions review with

today, October to will to on background event all Xth you schizophrenia on announced we along detail program I with an programs. join hope of in in greater us. updates be scientific CVL-XXX the our CVL-XXX other able be R&D and As hosting will discuss

Now, CVL-XXX; receptor our moving we're This antagonist use of the CVL-XXX. for treatment molecule opioid advancing DX-preferring beyond dopamine disorder. also is

Phase multiple compound, tolerability plan ascending single a study overdose-related CVL-XXX this patient potential misuse. area We all opioid important is need in and trial expansion an has can been overdose a to treatment deaths X to safety in safety of due where dose progressing area acknowledge, of non-clinical a is there excited to to this initiate we evaluate be of and with pharmacology incredibly As a and concerning Cerevel support and this profile. unmet continuing challenging

ascending submitted selective previously, to guided we or differentiated be potential IND a Receptor disorder potentially which action an quarter novel and CVL-XXX, known depressive also of second for As addressing the we IND in a an a initiate This quarter to PDEXB Phase major dose year, a healthy Opioid intend as in of this option first-in-human in CVL-XXX subtype to our MDD. year. inhibitor. the plan to fourth We is of third molecule lead Antagonist, multiple trial treatment we in a this selective in the volunteers X quarter KORA single Kappa and compound of year, continue much-needed mechanism has this CVL-XXX. for [ph] submit Furthermore, for

newly has in the our Cambridge and Crossing. are research of opened about of acted drug action address excited believe side discovery of inhibition in CVL-XXX been equally engine robust hindered world-class We dose-limiting by PDEX potential that particularly we at symptoms are believe both which where subtype, development all sparing prior selectively are validated to clinically MDD anti-inflammatory building By of we clinical of PDEXD compounds action has effects, we a non-selective At related midst a subtypes. molecules Cerevel, to mechanism across of this schizophrenia. brain-penetrant labs

premier neuroscience believe to will of maintain CVL-XXX chemistry, us are potent new compound combination rapidly designed to validate of most and research continue and and approaches utility drug to and us We have allow range potential the screening cutting enable It to identify we that processes us modification to some we disease. highly approaches, chemistry and engine advance screening regenerative expand all company. in address would selective looking clinical a candidates are enabling leveraging medicinal molecule with come. actively to small debilitating on to to that CFO lead neurocircuitry modulators a differentiated creating our are are potentially for and Kathy be lead review to of our highly now like to the will novel into over in library technologies, chemistry positioned performance MX-selective working Complementing of early of becoming of develop this to fuel gene AI-based Currently, a We demonstrated financial scientific therapeutics. neuroscience and in molecules. Kathy? to extensive DNA-encoded setting We're goal efficiently on late-stage and Yi, of we discovery to promising underlying additionally it pipeline the sophisticated understanding I and forward such, turn the compounds, as ongoing clinical to updating through you Cerevel's pipeline and leader are are identifying we neuroscience our progress the agonist and our activities targets molecule. edge muscarinic including to progressing world-class alongside months the the the our the quarter. optimization explore

Kathy Yi

you, We a financial today Good update, joining for you morning, issued that I will call. a John. which Thank briefly everyone, today's earlier thank summarize. release included press and

for quarter and our of The expense includes million which by operating the to increase the Our the the $XX.X and total our expenses were million late-stage increased million. quarter $X.X to by was R&D XXXX, of year, Relative of second equity-based progress of and the support driven last included of infrastructure well expense $XX.X increased of cost primarily as $XX.X results million compensation. early-stage G&A R&D pipeline. advancement second expense $XX.X quarter programs, second million as

coming of quarters the in have in expansion To-date, G&A programs slower general XX our do a as We a relative million $XX.X of expenses infrastructure growth were for this G&A expect preclinical to expect General the period clinical year. second we company. continue $XX.X and R&D but we same R&D, the last increase for increase the the support administrative the relative of $X.X year for to second of we quarter we included and our million assets. maintained equity-based G&A to as expenses compensation advance modest to quarter expenses over million.

our position. to Moving cash

As proceeds million XX, $XXX.X position net our cash of follow-on cash not were $XXX does and from our recent include cash approximately This offering June equivalents July. million. of the in

years redemption recently our to million late-stage clinical epilepsy, mid dementia-related In the $XX our of addition, full sheet, of including approximately assuming exercise. for well financial and creation additional programs inflection anxiety, programs in as PDEX. pursue and stage these outstanding the With for our very provide have to is position schizophrenia, next apathy Darigabat programs, Cerevel we've public the other trials current few to fund KORA which in in earlier opportunities a announced milestones strong well to such Overall, we're advance lead to up positioned we could as multiple warrants, capital, as point. value and balance Parkinson's, next

Finally, sheet to to like we conclude. I XXXX. balance into back now expect our call to our hand the over fund to current operations Tony

Tony Coles

Kathy. Thanks,

can progress here few made in short a months. you just see, tremendous As we've Cerevel at

heard challenging our extensive morning, with advancing order to therapies the in that you've novel most frontier. to neuroscience of last frontier we're great We faced this As pipeline at that some of we're diseases. forefront the medicine the in is neuroscience believe patients bring and

CVL-XXX and and journey anticipate as with us, program we brain. a apathy range you'll dementia-related for speed the where the schizophrenia. focus on our determination schizophrenia anxiety, CVL-XXX forward next three being Event you we readouts bring diseases, program, to be to X and R&D hope novel Parkinson's. able updates and and to vaccine mysteries on continue with focal we epilepsy, unravel along discovery this I data for other programs. join to important a apathy will will CVL-XXX our including as early with years, in other Phase X mission neuroscience our we the of And programs compounds robust of Thank [ph] disease areas move in going on dementia-related expect to successful Over with across do we're on And successful in October us ahead we for

want we In And trials thank patients do floor to our to therapies. of want I addition, With clinical contribution the give diseases. our their course, dedicated are courageous mission could now We as for investigators of neuroscience of suffering improve open to always millions to to I you. questions. who employees development do, not this my our in heartfelt I can from the our appreciation without the and the to of participants for operator, that continued lives

Operator

question Matteis first line from [Operator from the Instructions] Paul of Your comes Stifel.

your is line question. please Your open, ask

Paul Matteis

I thanks appreciate much Hey, questions. for it. taking so my

Tony Coles

Good morning.

Paul Matteis

Hey, morning, good Thank Tony. you.

that I the a in standing, is or upon Phase little I not development bit the path, the about that? just talking the you Xb shared, wondering could program there. On color of of giving And much. about guess press matters a rate I not CVL-XXX since and pretty for was safety robust. thank X why Thanks you so wanted Phase release question [ph] view development or you it if X data And comprehensive heart results start even were my into really, to then, on the data, whether that to is more supine clarify kind interpretation? your expand

Tony Coles

Okay, sure.

can ask both Paul, Ray, But And to why address So Ray I Renger don't may think there. go I of comments. additional John from some we'll have questions? you those start?

Ray Sanchez

questions. Good Hi, good Two Sure. morning. Paul.

process one year. program first possible. of imagine, we're accelerate and the data approach, in now quickly of terms patients the about sometime generated the all looking can comprehensive as So next excited the We're that's medication it as to today initiate quite that as at developing getting to possibilities we're and you and been to this trying of our in plan

get not clinical aspects, patients medication only can are Our program accelerating comprehensive of as so that aspects to at but the the the the we as that we also full soon approach non-clinical possible. looking addresses also

rest working and will on come, again, clarity So the along are months But we And data your now, of detail understanding together the in looks Paul, for clarify please you can question and what second with the like. we putting that the team. path that more on to program please? provide more

Paul Matteis

data we've or all kind the and ways. just Yes I blood supine if thanks was that on I look at of Ray. and to the the again, -- heart wondering both are heart matters -- if additional appreciate rate of you, Thank for and I standing interpretation seen think Yes. helpful. It it very presented I rate it? it. pressure. color was

[indiscernible] which way? So

Ray Sanchez

supine the it's in time -- the done one in evening. see we've as quite it No, observed as could by term over the and over that encouraging. is you But really time what's know, long clinically six encouraged you was see Yes. meaning we've and you that what one the changes we're term, really are and over over the and seen the meaningful long clinic morning weeks, the could quite as the

to move we'll monitor of So in continue, forward that as course, we development.

Paul Matteis

Yes, makes sense. Thanks, Ray.

Ray Sanchez

Thanks, Paul.

Tony Coles

Thanks, Paul. Operator, we'll take the next question.

Operator

question Michael comes line from Jefferies. next Your the of Yee from

is your Your ask question. please line open,

Michael Yee

Great Hi, good morning. hear Tony. your to voice,

Tony Coles

Good morning.

Michael Yee

mg, you maybe close, a couple important We about forward? they're and consider how the questions talk at nuance a look you CVL-XXX. one is that plan, How there pipeline. quite XX disclosure being timing the hand, CVL-XXX, your convenient development efficacious, slightly the broader doses mean, one think is question I mg had taken on both do data. guess, into can development more XX cardiovascular some the is different maybe a and just the, of on On about because of you data, would and data I little more and had PET but you that your of I on

be the question, for just the and So bit that about And around and you. that of other need managing the to geographies timing you going you update anxiety decisions that just you in are COVID data How to speak And in the Can do in involved COVID. doses talk think on maybe it's other areas you're around forward. whether that? in? your terms about then how a watched? Thank are enrolling studies

Tony Coles

Yes.

occupancy come anxiety dosing study impact. well, Okay, regarding the to I'm questions ask the going then receptor the Ray on and will the COVID the and and on take JR as PET to data update back the

So on JR, if occupancy you dosing. receptor could and the start data importance with the timing

John Renger

and once-a-day Michael the question. are reported in and achieved sure. the understand between are important we've you, to Tony. And the They that efficacy that the us upon for PK the you, so ongoing. and we exposures, receptor occupancy BID comparing and Yes, Thank Yes, PET the for data relating thank what dosing. studies

to pull have the PK is data we decision going will data up safety what efficacy be what the all and really and forward. so the occupancy firm and tolerability the around data, our receptor us data, the help And of doses together

so And data is that rolling out.

understanding couple together into Does plans we studies. of by where year. next We decision the we're information set we about with the that of of take an the our will all as the But be increasing of next doses we'll end at for this that late of development forward our need months make have through help? that the informed put to to

Michael Yee

R&D you reasonable Do Yes. the think a Day is timing?

John Renger

No.

So, we yes. number have a of study --

Tony Coles

to provide design No, priorities some do and clear data we of one may to the development CVL-XXX. is of get be what that. got by think I of but it Mike, the dosing and right want of oral this the indeed think stage set I as the we is have top for But for we've do study will we time, look, next to able if that compelling we answers, the always both a comprehensively, then direction and

thinking you our know. year. But provide we'll R&D Day updates complete we expect to plans, let do at our we in as event and the quickly as So finalize later this some

and standby completed. So tuned, stay but days are all will depend when those it upon

Michael Yee

on And you. Thank and other Perfect. COVID impacts? then,

Tony Coles

great. would that be could sure. if that Yes, Ray, one, you take

Ray Sanchez

Michael, are morning. So situation are quite the monitoring COVID How you? Yes. good closely. yes, we

Research the one Netherlands. the That's that As our is Drug trial do conducted anxiety impacted Human for has I To-date, a in any you to other was any as the we've know, that capabilities site, regulations, of mentioned, this being seen the type Center accordingly. site trial, at one of to Dutch of trial, but the not other impacts programs. because that because

occur. those contingency changes from of built trial. it the into enrollment to were know do this no if protocols calls, at anxiety address We're that other monitoring you juncture are But, we beyond the some challenges, As our plans to closely. have those to fortunately

Michael Yee

Thank you. it. Got

Tony Coles

Great. Thanks, Mike.

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

Operator

Matthew Morgan from the question line next of Your Stanley. Harrison from comes

Your line your is open, please question. ask

Kostas Biliouris

question how you about Thank clinical One Matthew. a about about and you the for landscape in view on Kostas Can is This dementia-related everyone. you. the of bit thinking here morning, talk this population? are Good your little psychosis. development

Tony Coles

would Ray, question. would syndrome, great. clinical those if schizophrenia, could other you one Okay. psychosis for That very but the and of expand in on is be dementia-related opportunities we're take possible it. if potential significance about and Obviously, CVL-XXX, us. of But, indications that that Ray, you appreciate I'd relevance not excited just

Ray Sanchez

there I did of psychosis treating Sure, antipsychotics ago. for for in and question. a available, that know, are that is trials box effects Matt. meta-analysis a decade stroke A over Tony. deaths. CV and a for morning, black a that mean, warning the dementia-related as resulted you Good Thank population in currently you quite FDA cardiovascular attempted need lot

so antipsychotics for is you be a pimavanserin great but of called that a nothing treat really is need. drug the risks. with with, there is to there disease, is really may psychosis to which used familiar And associated and those There current available beyond related Parkinson's course, patients,

treat in the therapies remains need population. that effectively the to psychosis So can have

regulators believe get in the that terms population. be But forward an pre-IND the to pursuing FDA the with the to going seeking be to clarity are is in we population. will that We going of path meeting what to indication

So stay that. for tuned

Kostas Biliouris

you. Thank

Tony Coles

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

Operator

comes from of Suvannavejh Sachs. question Your next Greg the line Goldman from

is open, Your question. your line please ask

Greg Suvannavejh

in the be. for Slide as what I 'XX, trial XX, case that could look the would I'm to guess, in that that endpoint established, might in just relates and the as maybe there questions I you It's of half realizing the it's just prepared even But the and us of we Darigabat being I'm think design Thanks your what of are first the certain alluded the what walk primary well of trying the about Suvannavejh. the trial, should much X outcome symptoms kind the trial the out as And a on good points And Greg we or Phase panic the should watch so though for kind and focus pressure when design, you it's through Can of good? thanks realizing list, a to, to it's Phase data impact update. now in taking within study features you're the morning. the sense study. Hey, could expecting out, for at also just comes a my study. that looking terms around it X Maybe us just comments, get of you small through should trial data? walk that it how results perhaps expectations are

Tony Coles

play a one, about a if Okay. little shows, a and [ph]. you talk little that just currently talk it any that available think Ray, anxiety Darigabat bit respond about bit for role, would therapies we where preamble, could the and to

Ray Sanchez

Thank good you, Tony. Sure. And morning.

their The panic So anxiety anxiety available and chronic by disorders or them, generalized alpha-X really but terms with benzodiazepines of some efficacy. of are, in so also therapies of course, that now and but of the side are for when all of of tolerance terms disorder, and opportunity, forth them all to limit use. really not and SSRIs are in are limited driven treat because somewhat SNRI issue really effects approved addiction, the their

has or at is and novel still our we clinically somnolence, selectivities drives alpha-X/X and at patients that but we're that sedated but importantly see that, with compound that what alpha-X/X/X believe have have anxiolysis can still anxious we So hope we you frequently. this

effective we of just not preventively hope also anxiolytic compound our become that indication-seeking treating So over our actually even events, development that therapy program. an this acutely, potentially and for is chronically but the have course can

in a there the crossover BID, preclinically need is step anxiolytic. occupancies design anxiolysis. So, Darigabat's that if potential be you our at two-sequence at this XX% to of is look first if an that effective two-period, understand actually is higher you to terms And receptor to really two XX design, occupancies achieve receptor we've the learned Darigabat and about of which doses has looking signal

BID comparator. We was X.X make from what compound, as XX to with allow Because that's understand doses extended and was of BID dose compound. included or a active in J&J to those to in of But them an the on alprazolam dose. also their to prosecute based used are seeing to their Orexin-X both milligram effective occupancy. placebo lower test that the the inhibitor release about That's reviewing decision XX% study importantly, differences receptor milligrams -- X XX% a milligrams minimum also

there powered, of this while predetermined not in words, in the terms induced volunteer experts signal what having in decision we working who data not no with statistically signal an -- but has the have well of well. a that understanding -- detect other the that population with as with been data data And should advisors are that healthy of terms panic should Darigabat it's we've read predetermined like, to other it's extent us in and compounds, assumptions to So will make model this next the But also will the symptoms, us give in designed juxtaposed the what of is understand is the J&J by allow Darigabat data, of a we've anxiety of specification done forward only of specific the don't generated collective look that well, landscape population. thresholds we've like. we what any it a group step the this as or understand

Greg Suvannavejh

you. Thank Okay.

Tony Coles

Very Ray question. Operator, for will next Thank we good. the take that. you,

Operator

are no time. There at question further this

may You continue.

Tony Coles

achieve. Okay. ensuring the you we've terrific raise Well, It joining was call. of morning. to really phase with us even in of that things and brings a capital Thank end think able the I and the this for [ph] the been the of this quarter, some guys us to other

important additional information CVL-XXX do dementia-related that's the We'll and significant so with on focused the everyone forward you we'll what of So we our to and really X on where as importantly apathy we plan advancing we're with bring R&D rest priority, pipeline, very why speaking CVL-XXX. the October and progress. on update for pipeline making focused are a but on on look to

the guys in you morning. fall. you we the Enjoy you. thank this Happy rest see for Day. Thank And joining Labor So, of summer; will the

Operator

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

You disconnect. may now

Cerevel Therapeutics (CERE) 11 Aug 212021 Q2 Earnings call transcript