Earnings call transcript Q1 2023

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Operator

Good morning and welcome to Cerevel Therapeutics First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note that this call may be recorded.

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

Matthew Calistri

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

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

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

Tony Coles

for thank Good us for joining business first quarter Thank XXXX you and you, results Matt. call. morning our

looking of of coming and and Ron leadership have morning and year. the the I exciting as known Cerevel that with announced data and President Chairperson notably as I XXXX more him we tremendous an for the will that's CEO prepares I partnering serve to This on expect seven than and organization experience the where most we Board. future, the for am decade next it a his in Renaud readouts Ron my career well with appointment the really as forward to Cerevel, return began in

leadership that Ron of Board now of transition The the the we company with know to time, required fundamental successor. the right smooth we worked successor. in strength right in Chairperson, change I and found return to my and this right right timing that and knew a the we role the the As get plan made

we former the the Ron is of lead next Cerevel. brain. as next both Ron to brings in Ron's cash unravel become deep in to Bio Translate a experience the discipline. truly steadfast confidence into on at the Cerevel work executing when our join Idenix he fit our Cerevel and life sector its and trials together great the to ability we phase perfect the clinical CEO of and CEO and mysteries have I of runway will as time sciences focused optimizing thoughtful with fiscal Pharmaceuticals, are

that neuroscience, pipeline what is to look to poised possible as to possible. as tremendous a patients new is soon has possible in options forward transform as Cerevel bringing many as and treatment we

status our me lead Let first of the with programs, Emraclidine. review starting

momentum has strong and and on Our Emraclidine or robust MX-selective adults program our schizophrenia of X track PAM, modulator, program data maintained EMPOWER a positive our half in enrolling XXXX. the for well remains readout first for with Phase living allosteric is

for are treatment the development year. delusions Emraclidine and pleased fast and the elderly basis belief in in activities prioritize we the to program of Driven of muscarinic mechanism, registration Alzheimer's other hallucinations we of of and for to disease initiated label we of important medicine psychosis, At treatment ADP advantages people who last to program We associated the the with transformative exploring extension end addition enabling to at completion designation selective, trial targeted, our this need to bring we're CMC advancing in an trial potentially Emraclidine Cerevel, and Phase our preclinical volunteer continue a healthy open by order Emraclidine Phase and also to support Alzheimer's track receive were disease psychosis. differentiated strong conviction an it. in and on the necessary the to this FDA a accelerated informed for X committed X

Beyond our selective multiple and serious alpha neurological PAM for we is another X/X/X ADP, potential program pathways GABAA with conditions other our advancing by Cerevel selective therapies also are with indications. Emraclidine schizophrenia with Darigabat, novel in approaches. work targeting new

is mid The studying our first in the tremendous fourth unmet of an need most disorder. for epilepsy, patients focal need today these announced epilepsy, readouts stage year. data XXXX seizures. program trial, who REALIZE one our mid-year expect neurological we X seven common We of Phase better are Through readout their Darigabat area to next this control anticipated that we to of of as late

medical anxiety potential related unmet needs, of address not disorders. Darigabat have the to epilepsy, confidence potential the for in We only important but in tremendous of treatment

subunit, Given of profile X, driver alpha we receptor believe effects main the its subtype its receptor key the is side of for and selective benzodiazepines. avoidance

be future trial look disorder will as Phase and initiating and to We you with updates quarter this our trial providing planned panic X forward progresses. as that

in treatment the disease believe Turning disease. as trial. choice spectrum believe Tavapadon X has monotherapy now as the We trials adjunctive to TEMPO We are the with DX/DX the the the disease newly to for Phase agonist serve patient diagnosed therapy. directed registration cornerstone therapy and choice ongoing All known of disease of in to extension potential collectively Phase open-label establish X partial Tavapadon as ideal could Tavapadon, Parkinson's our of Cerevel's the development along preferred program across the Parkinson's for three treatment Parkinson's progresses. first as the corresponding trials L-Dopa both

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

trials, we need range While the fiscal we remain single-mindedly of executing discipline. broad focused for continued recognize on clinical our

planned in there operating potential. data and explain a the priorities, lead reduced focus XXXX long-term moment, while for we maintaining where timelines rigorous early specifically value investing our pipeline a we our our on our have key in believe detail expenses, is readout, in creation will Mark assets As

explore sharing or we business partnerships and We continue as such risk and to additional opportunities partnering our monitor development where appropriate. will will external to spend XUS gate arrangements opportunities and possible, for expenses manage as

cash, our XXXX. securities marketable equivalents expected our XXXX data seven are data and into anticipated to support operations -- Cerevel's and readouts in cash fund

see ample X and us make to the cash to The line of ideal seek we and to top data readout runway for have future racking the serve. a this welcome the business Ron program. our we as the team we Importantly, of look Cerevel patients strong time Phase bright fundamentals our to through forward to

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

Raymond Sanchez

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

like for seek Cerevel leading Renaud to some diseases. First, the of new to let treatment how as fantastic Ron welcome to options expertise most dynamic Ron's organization. ours, develop me fit we organization delighted am operational I the neuroscience and say in challenging experienced

Emraclidine. of Let me with start a review

trials enrolling Phase are robust well. Our X

EMPOWER We an called three worldwide look adequately and expect with EMPOWER to X continue acute XXX arm the in and are each data next living and being progress to symptoms. powered forward first exacerbation conducted psychotic of trials half schizophrenia will this and These two experiencing year. X of adults randomize

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

for to prioritizing label priority extension safety program enrolling completion our pleased necessary XX-week potential studies trial, clearly X, are a in Cerevel pharmacology of also I am open clinical to non-clinical date. is in This patients are top progress the package for we in accelerate We our and Emraclidine EMPOWER order very a the and registrational schizophrenia. with and

We clinical are with development Alzheimer's guide also The Phase plan. our moving development trial X of psychosis. which results the Emraclidine in our to healthy elderly forward volunteer support will of disease

chronically. both comparable Darigabat, the has potential a Turning panic available over currently anti-epileptic of We expected PAM, receptor profile now GABAA epilepsy side our provide action for mechanism alpha Darigabat's that to in be potential for development the used and anxiolytic activity tolerability effects. benzodiazepines may new novel currently Darigabat and selective option to disorder. reduced believe X/X/X treatment and for

progressing we X now results trial Phase is XXXX. REALIZE Our expect and mid-year

an enrollment mitigations are our to in quality. important focused data on we continually advance We team deploying steadfast address remaining have experienced and while therapy, is new to headwinds commitment this that

realized Darigabat in of We remain by XX% rate the the into patients which rollover epilepsy. efforts extension, label speaks to our open ongoing encouraged focal in benefit potential the to

disorientation, on significant a is pain. of a chest epilepsy, of potential later excited expanding we're application least Phase initiation proportion patients have remain sense disorder symptoms Panic Beyond pounding at and doom, present heart patients a disorder of impending panic our of to including a weakness, estimated response constellation episodes partial the treatment. rate, about therapy of third untreated and and a dizziness, panic of It to X with this quarter. the Darigabat rapid expected trial

treatment effects Benzodiazepine, non-selective utilization but are reserved while and to can non-selective benefit in provide commonly benzodiazepines. result the the option, is We PAMs due potential acute selective used effects. anxiolytic that believe severe typically other which Darigabat addiction for patients are GABAA side a as GABAA more nature PAM as panic an from minimizing side of

future of panic experience design could our progress in potentially Phase details as provide We'll at trial of potential a attacks the improve X daily future panic and at living the more disorder. panic Darigabat's well-tolerated option disorder patients treatment on with a time.

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

longer advanced to improved due for be XX and dose clinical control and need half-life new for reduced potentially adjunctive delay of the dyskinesia. The escalation. Parkinson's enable patient, hour could to motor therapies its preferred course, L-Dopa is, treatment of incidence symptom with the more a L-Dopa objective profile and Tavapadon tolerability For

in or of extension Tavapadon half open ongoing in the expect which three we As and XX% TEMPO all more. of Tony of discussed, the for Phase data now for X X seeing X as rates label known half with rollover second TEMPOs the X in first XXXX collectively We XXXX. high the and data trials of corresponding are our along are TEMPO trials

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

am neuroscience experienced data intensely trials XXXX. focused an of in of forward to and quality importantly and deep remain sake collection advancing updating look have of trials conduct, on progress we mid from expediency. team ahead stage clinical We the the data the as maintaining broad to pipeline our We to the of compromising on assets. clinical we seven looking our I late for you to not

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

John Renger

Thank morning, everyone. you, Good Ray.

I'd really like warm underscore writes Tony to together be I'm able personally Ron. we'll chapter. excited First for accomplish Cerevel's to next that Ray's and welcome to to all

with extremely development programs. made and I'm the early clinical pleased that progress research in we've our

responses, address major at key dysregulation psychopathologies a via correct Let of signaling. is receptors natural behaviors, me opioid Kappa use reinforcement CVL-XXX. substance including nuclei. one and stress start core receptors with point called both KORA, stage or [indiscernible] of key dynorphin selective an a including clinical coalesce the disorder believe effects drugs of that Therefore, linking disorder. the the mediator receptor could approach of behavioral of kappa and range of we The our depressive overview and antagonist, kappa reward opioid behavioral represent use

depressive Recently, depression, completed see mechanism the anhedonia peers. clinical by refer of models across proof-of-concept this and our improvement. in promise Phase action novel one shown of We demonstration withdrawal of disorder of to to symptom opioid a of major preclinical number a trial X encouraged has

occupancy These clinical our receptor revealed PET receptors dose recent receptor non-human with human hand the demonstrate at data engagement our Our be of and receptor XXX our examining inform We binding been multiple currently compelling occupancy These and on being lead evidence This dependent the compound. opioid potent selectivity and clinically PET will compound. believe concluding. currently, are data presentations, target dose receptor knee dose a sending is our step of progress ranging important multiple indications. more scientific study binding initiated and of this internal molecule receptor a and PET trial featured alongside occupancy for tenfold confirmed overview have across XXX be least type clinical recently appropriate X kappa receptors the human expiration studies selectivity kappa of studies. providing important Phase in in potential the single will receptor to has XXX program selectivity of to which primate

Shifting in secondary muscarinic would our upon with therapeutic is potential the the based believe MX receptor clinical own gears, experience MX I We the like work our selectivity of with pathway. today. highlight to Emraclidine firmly

we agonist in disclosed, our a addition studies. advanced previously molecule selective As Emraclidine IND into program, highly to robust enabling MX full

well the further Want program strongly selectivity to the to updating on and are understanding work this current enable earlier supports stage future. our supporting filing MX based bolstering create to our progress be receptor our confidence science agonist the our a hard a full late NDA Our in utilize as clinical We'll sincerely in thank stage ability at approach near development, as franchise. teams of and program research desire expansion, activities. behind designed to therapeutic therapeutic selectivity muscarinic indication the pharmacological

scientists of to skilled continuity passionate, for our come. are asset our earlier in to the As what at portfolio I is stated do neuroscience expanding continue highly and and previously, and our are purpose-built they actively stage have committed, years mysteries pipeline are unravel the many appropriate. We'll experienced, to ensure the diseases, treat brain we updates our in to

going to quarter. review the financial Bodenrader, now our Financial for to Mark? to Officer, it Cerevel's hand over Interim Mark I'm Chief first performance

Mark Bodenrader

I'm let of our John. and target welcome overview financial value highest Cerevel in also Good Ron. a an in warm investments you, everyone we the opportunities me strong to as position add morning, provide to on spend Cerevel Thank pipeline. pleased

sharing an XXst, March totaled $XX.X our And $XXX from and arrangement. cash, of in we April, marketable Tavapadon million risk our received As securities million. equivalents cash XXXX, additional

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

million. due expense expenses and $XXX in to open approximately R&D quarter total the first is the the Emraclidine to expansion supporting ongoing schizophrenia includes Relative of personnel $XX million, and G&A our This including label approximately million. increased For and extension by $XX $XX last related year, primarily Phase safety expense infrastructure XXXX, million pipeline. were which quarter other program, expense first increase our operating the of of and two costs trials continued investment advancement growth the in our X trial and of R&D

was advancement to the costs and due of first the for quarter to million quarter $X personnel the increased in expense last G&A year. first This our growth higher by organizational approximately related over programs. costs support primarily other

and on this additional spend the gate activities certain top focus with planned achieving mentioned, gated key shifted appropriate manage maintaining commensurate in our achievement and Tony Darigabat data fiscal expenses and achieve clinical reductions trial discipline Tavapadon, as of line possible. activities, our to planned execution spend we As our well expenses timelines, driving reduced operating in readiness pending XXXX executing NDA and growth changes these priorities while our reduce headcount timelines for in we for rigorous completion. timelines, opportunities and and our spending, We'll To incremental on monitor enabling including continue planned Emraclidine year. where as focus

closing, we In well remain capitalized.

and cash opportunistically our continue operations our us through resources for next support our programs, late the will stage to in to creatively seven our readouts about and that XXXX expect XXXX, and us expected think to balance mid point strengthening of We we each allow into fund to achieve further inflection lead the sheet. data will

to remarks. call the back concluding hand now I'll Tony for

Tony Coles

we living pursuit to medications team with the We're the proud of some of all doing quarter in accomplished and much the bringing needed with diseases. date, Mark, we most work pleased very you of debilitating our joining results. Thanks to is the neuroscience to us thank for what discuss patients are and have first

healthy transition executing We're as and to welcome time our are underlying are and business smooth next a Ron strong. when pleased at a leadership the CEO, fundamentals

We pleased XXXX the our and catalysts have TEMPO first forward year, and in and a of schizophrenia half in data next of and are the year. momentum Darigabat Emraclidine in living with middle continued robust expected of in results adults announce the results next look set X to to program

into to cash track our creative record given under for pipeline to of fiscally especially with the inflection deal his lead roles. fund of our remain remain to we new and maximize the value Ron's disciplined deliver point assets, prior We each opportunities the through of next collaborations and operations open partnerships and making, his leadership, XXXX in

set through been than Let quarterly new of an me the organization vexing to Cerevel this additional are met, with that the privilege will role came and this Cerevel prove scientific has also neurocircuitry to CEO, done a more on a facing as time. lead thesis this add, those since three launch for specific new CEO do. could sufficient very pharmacology took I with last be medicines my differentiated advance patients of exciting years to objectives call such selectivity, ago and what And capital focused tremendous diseases. goals subtype raise important to that receptor I've I on

is time to Chairperson, the today. and that to for I as forward partnering company. journey role Now accomplished premier look tremendous become our proud I grateful we continue and we've closely Ron, return I'm to on team the all neuroscience the we've team the Board assembled, to the as my with of am and

And operator, to with like that open I'd floor questions. the for

Operator

Instructions] [Operator you. Thank

question line comes Paul from first Your Matteis from Stifel. the of

Your line is now open.

Paul Matteis

appreciate taking wanted or there's if fixed. as the to in on of that operationally needs been I investor has issue the look one much of pipeline and Hey, questions, great or stepping it. and now, there's Ron, I for Ron, something Cerevel forward And again, ask an number dialogue. right reconnect question be you to to thanks underlying Tony, concerns you and wrong, a continuing I to it's the so if guess with you CEO, execution delays a

your So, you and do I was at on looking differently. just you what might kind at you look might step curious in perspective be to that, what as and of

guess community anything to that first that granular a is you solidify end, level investor more Thanks half I the competency And so help fully can that just Emraclidine on there XXXX track. much. convey can specifically, on is on in

Tony Coles

Paul, middle on to He company actually begin Ron the the tenure the is with So, until call. hate his not disappoint I of June. you, doesn't but

Paul Matteis

bad. That my am I sorry. is

Tony Coles

question. alright. sentiment quite That's no. I of No, quite But the alright. appreciate That's your

that. address look the the business And or I at in so four I to which lens and years on had all so. is have reflected that the the me this let we've obviously accomplishments over last

think I So, we'd of that the the raised amount harder data and the underlying delivered be a company, particularly company to prove find thesis for the pressed neuroscience. kind in of has capital,

delays surrounding as on you of you things, control. you best the And that earlier can't trial control clinical we announced as week, But simple matter one that when let and timeline And obviously make valuably can't reflect the this key these you did this that. has disappointing been we created of we've all news CEO, of control as have this everything I achievements the things one. in case, a business a as likes no overshadow

what that leader CEO it and does. a does, bring company is own long leadership, even expect of That's style the insights a what is his and things the record his that's from to, great make he'll better what is than today. Ron's his own So forward looking great and particular leadership, unique one success and track this of great we I'm of

of on you fourth to impacted delays of of which the industry kinds Emraclidine impacting seem by today. quarter evidenced for well. terms Everything year. studies, our as timeline have the is and announced trial of reassure ahead the Emraclidine as inpatient some this me last let don't data on in track next which and on the our things track The that be study And is Emraclidine ABPM time the delivery And finished we half are of also of year, of readout with studies. in first

ground importantly, trial for those of and track. momentum in made back Darigabat getting created significant we've on up Tavapadon And timelines terms and

proud really control, control out and we the has the the the So of things question, what I can We I'm can as all, the in we we of of best reflect team that on thrust things done. can. make

Let's take the next question, operator.

Operator

Your from line question ISI. the Umer Raffat is Evercore of from next

is line now Your open.

Unidentified Analyst

is This Fury Mike for guys. Hi, Umer. on [ph]

as me. with Just you continued your Tony, Chairman. two absolute it's wish working you success an pleasure certainly and been for we in role

could which to CEO? here surfaced, In any Okay, offer preliminary questions. is recently that on a down color in related is And this SPAC way any strategic engaging are stepping your your so currently in discussions potential Tony, transaction. filing SEC sponsor my you about this? as any said if

emergent Phase X [indiscernible] the on results, the improved that separately, trials. their over we response And three of placebo saw course increasingly

you. an what us Cerevel the X is outsize in of remind doing mitigate trials? risk their effect to So Phase placebo EMPOWER Thank

Tony Coles

that conversations question, filing. on comment, particular Mike. with this the I What can't speak investors, their for following that filing your did of the are may, day attention strategic that can or they update one the draw so from language. was will filing there to perceptive no I SEC particular a revised to I underway, Thanks And and our transaction with filing is dispense won't

you following I So but that where what they and comment I update tell came the date. is, and issue can can't retract did from, on

of filings. SEC their you refer So, SEC full I'll set -- to

the As to one? take and why question Ray, response, placebo that emergent the three don't you

Raymond Sanchez

correct thank the response you you lot for something is plagues that are of the landscape. Mike, CNS So, placebo that really a And question.

doing mitigate of limiting with the countries the sites XX of that XX were more to sites per no than factors, each to to so, we're number the mitigate really And ensuring it's risk. number ultimately the trials one, this right And trial, And also response. are also trial. is in into success have really what in so methodologies going limiting because placebo place the the in that. drives achieve enrolled really is We're many to the Emraclidine that that that of of risk And the we're we're trial. by that we patients a but driven of

implementing ensure as each the that mitigation attenuated finally, response to is protocols can. And placebo also placebo risk importantly, much we of site we're at as and

approaching like we a very very collectively, vitro So, we're response. mitigate just results really approach we where the to robust placebo we feel that got X confident it Phase

So for thank you raising that.

Tony Coles

for Operator, take question. Ray. question, you, Mike. the we the you And next Thank will thank

Operator

question Thome TD from Next is Joseph from Cowen.

Your line is open.

Joseph Thome

we my on thank that Maybe epilepsy morning the that study, in there. you recent one Hey, seeing for XXXX Darigabat enrollment you maybe are confidence taking readout mid and issuing gives question. what of you Good trends Phase guidance? forward in go terms X, you do would anticipate were concomitant And when on you. to patients you'll that the decision the Thank look [indiscernible] points be of into able include what to kind or that? that

Tony Coles

Yeah.

our Let just monitor carefully all very We regularly clinical by trial very, introductory timelines me comment on make and team. the clinical operations an that. updated get of

So, We let long Ray planning impact Right? our about various and and speak hard the we expectations. about but the mitigation I'll thought created. our that to are the has some clear permutations, momentum of

Raymond Sanchez

Yeah. Thank Tony. you,

that can epilepsy headwinds, to industry our seen momentum is that program, we've extremely midyear approaches year. data we We're despite achieve next that. we've confident implemented And several mitigation increased which Joseph, deliver the encouraging. in So, by

that we the of rate how Phase X clarity medicines are really that trial CYPXAX give limiting in the the trial program, can design inducers patient are drug enrollment. Phase that a to we Regarding interaction be limiting allow for terms will us conducting X that'll

DDI the we to that moving now Phase in that clarify X using trial approach be So, able be to an forward. we'll using that have we're --

proof-of-concept seen challenges the same trial. don't we enrollment that the we've in anticipate So,

Joseph Thome

you. Thank Great.

Tony Coles

question, operation. Next

Operator

next from Your question Yee Jefferies. is Michael from

open. is line Your

Michael Yee

a thank a miss thanks I morning, you. the question you've lot appreciate done here, behalf Tony had and going Hey, and and you. know on for all of we're Good of thanks to the us, We … work

Tony Coles

Thank you, Michael.

Michael Yee

Emraclidine. had on We a question absolutely. Yeah,

You that are, the timing necessary non-clinical Can only strong what the there's around also very, in those? XXXX, assuming first remind data, very of that's competitor. And press the us presuming release, you in this filed, is clinical strong you of really course, the data just really half quickly all a pharmacology as question studies reminder, very year those appreciating could Thank a mentioned get ongoing. together of you. and how the behind

Tony Coles

overhang, to one. and doing. the do asked Well, do that work the Michael. I we ABPM question, and to comment answered our that that question, I'm think thank about was to move decision an view a mirror about have and as And table least we the pathway strong, to we've agency a really some specifically smart now for good, at got package. you are conversation the that's knowing the the strategic present take study decision additional in off what to going for early think, of clear that the rear us. to to a do ask JR need I he'll and

But don't you together. enabling other JR of as actually this work may the where the and you comment about some why you regulatory will talk all we on just ongoing bringing that's approach as think JR? about

John Renger

thanks and Tony, for the Michael. question, Thanks Sure.

we're objective minimize time to all as that the data for readout between the work what potential mentioned, for So, doing you yeah, NDA. submitting is the the our is so and

do of and you're modeling is studies, of the that of pharmacology all And to clinical complete aware [ph] the evaluation all the studies. the tox work so, much fully as we preclinical have of studies, to

amount that We sure we we of all a have work CMC significant do to that have make submission. to module of need completed the for

making And for of have place we so that. that validations actively controls work and all is sure underway, that in the

sure that is are is that to on filing possible. we critical getting making nothing And path controllable, soon done as as so, the

we can to have full And possible. as go data, as once to that ahead are so we we submission make quickly the sure steam

need achieved. detail a in but to go getting be So, I I don't needs submission, all think included that as that more into work to you're everything aware of is

Raymond Sanchez

trials two know, ICH and needed explore at they dose range, a these have safety are hundred year the XXX that at for least. months, exposures the you controlled, as powered also full Michael, that are And adequately will we of one while

collectively, and so path indication schizophrenia meet clear the criteria. forward is And FDA for the

So, trials we're FDA the that when comprehensive to they package will hopeful will, that if these go have trials readout. with to we the we a hope

Tony Coles

guys. you, Thank

operator. question, Next

Operator

Morgan. Next from question JP is from Jessica Fye

open. now is line Your

Jessica Fye

morning. for Good taking Thanks guys. my Hey, question.

expected Emraclidine to or trials anticipate XXXX. TEMPO sequence? you the can the readout reading concurrently half I'm us, X you EMPOWER first all and of out the expected now, curious, first? which should we And With you. in trials in remind Thank

Tony Coles

Ray, want take do you one? to that

Raymond Sanchez

Sure.

the what readout half time. Jessica, XXXX. at can don't say that trials specifics have is So, any We will this of we in first more the

In to enrolling at we readout short X for if with EMPOWERs and But of of they're more well, specifics will but really time will that we closer ready this on to of give those, more each get come as -- the X, terms those juncture, amount they within within timeline. trials. specifics give in and not a we're very

Tony Coles

good. Very you. Thank

Next question, operator.

Operator

Thank you.

is Mizuho Suvannavejh Securities. question Graig from Next from

Your open. line is

Tony Coles

Hi, Graig.

Graig Suvannavejh

are spent Tony, how you've many well. appreciate you? as the that Hey, and of miss you us, time with and much, we'll Thanks so

and to of to just thanks roles? you curious want focusing my that the be have first or or able in any So, you'll go good unquote, up initiatives when more back you've maybe dual again that's So in to will role. time on related on kind I to be feel quote versus Chairperson's past pick the just able spend Chairperson, to as better on was prioritize that being there that activities you question. luck before did had the that, Cerevel are

late question but studies. fact the maybe has a you to get package specifically that a answering a any second and my is require bit question things that broadly you for data I and question you for, same employing. then little the regulatory won't, program more accept confidence the can And ask Cerevel will data additional example, more if way, to commented you're know on FDA a give the question, Ray looking that is that just different in stage point they -- strategy more in the Emraclidine that accelerated

I think to questions X your getting approval. we've what EMPOWER lot a investors for Thanks. have should being confidence been in and of thus have as an X and level you sufficient of studies

Tony Coles

the Graig want with the on we second don't comment you question I Thank question. for start to and Chair. Why first,

Raymond Sanchez

Yeah.

morning. So, Graig, good

the for their historically registrational request driven met two So, additional potential. in requisites But again, forth described trials, being we we X requisites are work FDA. Obviously, we for about be the confident here. that discussion agency. confident EMPOWER the are trials purview the to But John being the of have data, in these and we it's and are very and meet all these that the fact, can't confident two that their FDA X, has we'll very in it'll speak criteria that that that's the criteria that But terms trials with earlier additional put data the all and registration. done feel feel meet

Tony Coles

it's think and think And Ron Chair, ability as say he that continue what as place team to the to have full and that foundation and unlock, work important lead to build really I'd shareholders. range have for is, the joins I I obviously that when company the full CEO, really I to to continue to the into create put value to date and company, on for strong to and patients

very the Ron smart, which known along a will think than of is for have individuals, more I partnership with He's leader. deeply a I because the each Ron. decade, the in we collection values-based we a experienced, we other, particularly And of like with very get well. strong, of Board role be enough quite have, Chair, role

a really with partnership for the and and that Board partnership wanted everything be the as will team realize I think the to as across always both lead that company. we I Board Ron effective work I the

for So, the and no you My be what to expect thank new lead the fashion, do. to job projects. Board in I will that's question. great But

question. take let's next the Operator,

Operator

question from Goldman is Sachs. from Next Madhu Kumar

is line Your open.

Omari Baruti

have Madhu, competitive is and Alzheimer's schizophrenia the related landscape This morning. for in question. receptor one for Good think you muscarinic about the we so psychosis? How evolving do Omari space on

Tony Coles

the to ask at make comments comments JR? but to scientific the on a few JR least And clinically, going side some first, I and there you if things. don't target know I'm of have Ray,

John Renger

Sure. question. Thanks Thanks, for the Tony.

created space would what that number a action, say we in of we call yeah, new effective that's a a this predictable. I you try been companies focus see when take do knowledge always think is I of on best-in-class. to mean, I the find safe field. advantage entering as So, company, to what mechanism quite of we see I I mean, exciting. that it's new think you always and

beneficial effect means is to us side patients. what as really so, And profile having a a compound highly that effective for

and think that's us chemistry both And pharmacology profile important I in through and to is that receptor effect side our delivered what achieve selectivity efficacy a you've seen date. benign

difficult think to what of a there's that schizophrenia, our of that, And is the And I to thinking I physicians lot it -- is as to as meaningful be the that think the lot I it's excitement, it we've a us molecule. are usurp in seeking, about try and so come at mark. in confidence really going of symptoms very be really medicine while looking a to for the to hit I patients having and company treat for think going what and best-in-class. thinking about patients we're have far a

You've the seen today. efficacy effect the and profile side

believe the -- lot and into do as molecule of And as And I mechanism. have a entrance as quickly the in this in lot achieve this delivering really a best-in-class so confidence while into here that can area, Alzheimer's, into that possible. I we expect for and goals particularly you really of here team a that we've mentioned, set we have

in the but great always information being and have confidence field, the a it's really best-in-class. to to have competitors us expand I So, in knowledge

Tony Coles

if if by of strategically an earlier the and good that is Well online, with approved agonist, stages second MX it's the -- that me and have act MX as thing FDA, Emraclidine in have a data we agonist. is that thing, are we comes great this that time, the positive, of Ray is will and about JR The comment, reminds all the before exploration. the

into believe and about PAM it. having development an a we're if of really build So, through we broad brought a right us both MX, patients in portfolio can strong area agonist that selectivity franchise a be are we and leverage this and that opportunity to gives the later,

-- that all that So, the of time. comment make us that I of reminds because JR reminds just

enforced on selectivity. comments clinical some Ray,

Raymond Sanchez

Yeah.

new that we're I you dawn only as are former a molecule I'm thrilled. titration that know, as So, now side daily that be adherence of something And think patient really more adherence you a therapies adherence. two key a we have clinician, and is that relative couldn't upon have are is of dosing, which And excited class know, factors a for lack once us. requires I benign as we that's recidivism. no And critical important patient effect leading currently. a have and to to standard-of-care

franchise and we're to deliver soon excited possible. to that So, this have have as best-in-class as us approach this we're delighted to upon patients really

Tony Coles

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

Operator

Next question Douglas from Wainwright. is Tsao H.C. from

open. is line Your

Tony Coles

Hey, Doug.

Douglas Tsao

Hi, morning. me? taking you good morning, the Can and for thanks hear good questions. Hey,

Tony Coles

Yes. We've got you. Thanks.

Douglas Tsao

in the Okay. Tony, Great. role. the And congrats shift on -- on

MX the assets spoken potentially lot and that well are schizophrenia and both for both up two following So, the molecules, suited it upon maybe of times same be for question, I on last I with to pursued helpful having I the know -- Emraclidine you've A MX. value as well as might just both different expand bipolar. schizophrenia mean, about or of better asset bipolar suited. pursued as the the mean, in as typically

also of So you. them, commercially, and about of maybe talk having Thank the but scientifically. just value two not

Tony Coles

might course, is, don't JR, but days take JR. Okay. we one? the bit agonist, on play a Go of why on you out. this little speculate can It MX early how that ahead,

John Renger

and the for Thanks question. Sure. thanks Tony,

illustrate the that, an drug molecule scientific MX. bringing full impact a which that behind we're difference Emraclidine, So, how targeting, system like perspective, the is, compound the which agonist, is that which the receptor case, the is we're really and on a from between the so long modulator, have is a in positive this does up

thought be that something amplifies neurotransmission occurs the that So a within modulator system positive allosteric can of the naturally.

that is it really doing has and active. only it So is when what we're really up, ramping system an effect

a the the concentrations that is molecule hand, the will present after. as it's long be as go on about receptor think full in that it you agonist, other activating to intended effective, are If

as thinking the as molecule continuously treating want the agonist, And full you levels high a is what the you're by the so condition push about time. hard to keeping is really all can mechanism with where you

the take overactive been in the to able be what is system approach schizophrenia learned So, PAM been this symptoms. of very provided actually we've case something has it's and advantage schizophrenia correct about and activity effective of that with actually to really that's those endogenous in patients used that's the

full about psychosis, difficult actually psychotic over hitting get what you preventing really benefit prevention the really in most a really where about have about treat cases and you can happen break, and really the the about of thinking to If continuously. psychotic most a start or agonist what That's to severe think hard things think types a like system a think PAM. is could where and dampening of you of situation breaks, that the you're in occurrence

to what push we work we're to does the what make In is there way specific going diseases are drug full you activating full system actually remove so mechanism that is diseases? continuously to Because of the the as in because the it very you we're And a trying effectiveness about condition which agonist? do that a that have hard kind In thinking the conditions system fully over a is to with agonist to which of But in a that's specific doesn't treat sense we a actually as all can it. of treating system? really neurocircuitry want cases in time reactivating there you're continuously thing. beneficial would where downside be when the have hard, be cases push that a of a

get and And that thinking for best really expansion. the not is picking about the We're backup group. Emraclidine. so, We're we the the to so the This treatment said, patient agonist. position for disease as insurance we're about not thinking about molecule about thinking we've best a right always for best state, indication an

Tony Coles

agree -- that's the of that. with And all I --

both point think us. commercial view, the to moment I as obviously MX from appeal patients ago I a is the Emraclidine of a business and that's terrific. acknowledged And to bring great opportunity a

for more. stay tuned So,

about MX excited are We franchise. the

next take we Operator, the will question.

Operator

question Bansal Next Wells Mohit is Fargo. from from

is now open. line Your

Unidentified Analyst

from [indiscernible] Mohit. morning. Good This is

Phase X? enroll study the of place For the upcoming trial in in healthy X expect we Phase panic disorder to any are design relative you key and as there should population the disorder, panic patients differences previous

Tony Coles

Thank Great. you.

the the X, Phase study the Ray? particular Phase design that question has volunteers, done to that b think X I with proof-of-principle in do healthy and was so,

Raymond Sanchez

healthy trial we're X know, last conducting finalizing with will proof-of-principle We're the hypercapnia volunteers. a currently The So February trial the with trial disorder. quarter, that patients be be proof-of-concept year Phase was going as readout that design trial that the was in panic FDA. you in of this to that

I or near panic But historically, XX future. tuned with what's very that was years the as design what or venlafaxine approved been say. that like the done so in trial look reveal disorder. in recently since stay been should it's we is about So will last But consistent

with that ensure and to we're closely very want what the agency doing agrees them. we working So

So, stay for soon. reveal that tuned design

Tony Coles

next the question. take will we Operator,

Operator

question Fitzgerald. from Next is Charles Duncan Cantor from

open. Your line is

Elaine Kim

And This how you. Hi. to is Thank what EMPOWER? is for on going extension just Kim Elaine enrollment persistence? Duncan. label wanted the for you provide specifically, on ask color can treatment Charles into open compliance I or

Tony Coles

to take last Thank And those? operator, for Ray, you be this question. has do to you I want the our think question.

with we Ray, So then don't some why you make and wrap closing comments. I'll

Raymond Sanchez

Yeah.

Darigabat rollover program. expected as of the for the rate seeing are fundamentally and that. we've But dynamic robust trials schizophrenia as for trials EMPOWER we're different, and acute epilepsy Tavapadon not Elaine, the is for So, the

very NDA is sites filing really we're a so, our rate that we at we're ensure different dynamic, meet exposures the population, are that of not ensuring get the they're a And exposures. different that needed It's high the needed And to not we're any doing filing. can by the to we ensure exposures having confident very that to way to that volume trial limiting the a limiting point. are that rate but

Tony Coles

good. Very

Elaine Kim

you. Thank helpful. That's

Tony Coles

you. end some closing to turn comments Thank Ray. to the over you Okay. make that, and I'll to Operator, Thank for I'm going you call.

create the the been to the has XX well shareholders changed, the have have reflecting my as therapies the years value which essential for is about have on amount do of changed, industry. and have a And who hasn't, remarks, care what evolution but behalf that people significant I mission those of been in to this The new I in to way and in prepared me was in a work CEO. my do I to of patients, we have remarkable spent really this wonderful do experience bringing industry. our time of do it's a As faces as said been and in you XX-year we cap watched career patients. morning for those and that that

difference in So of experience the just to believe my it's beginning been with significant career making a are great me in this cap the particular industry pleasure biotech for I at where a we neuroscience.

discuss enhance existence. lives you we with a I because the thank the that exciting my better have I you to Cerevel. I describe and live diseases, the thank guys thank teammates, think truly opportunity families thank do interactions and I our all to I these I and of the importantly, things And those can by employees, enjoyed Board all of make and affected

like a Thank more I I wanted bit impacted you. than have how me. usually openly little about a really to does but anchor reflect feel sign news isn't, just off. this you And guys do It

to text, best wishes, you answer deeply for emails, thank do and well very, are and will my one. I deeply, the you the very each So, appreciated they much, all thank the

for us Thank operator the call you helping today. with

Operator

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

disconnect. You now may

Cerevel Therapeutics (CERE) 3 May 232023 Q1 Earnings call transcript