KRTX - Earnings call 1 2023 | Karuna Therapeutics Inc

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Operator

Welcome to the Karuna Therapeutics First Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note, this call is being recorded. And I will now turn the call over to Alexis Smith, Senior Director of Investor Relations.

Alexis Smith

Thank you. Good morning, everyone, and thank you for joining our First Quarter 2023 Financial Results Conference Call. prepared call and Bill Officer, our Chief Troy begin Troy call Q&A the Chief President who the Operating on as for will our Officer; well join Kane, call. Executive Ignelzi, with Officer, Officer; joined and today Founder of Chief Meury, by and will Andrew William I'm Miller, as Commercial and who remarks portion Chief and Financial Bill

our visit we to investors.karunatx.com website I of everyone Investors Before release today's related at to find presentation the press begin, our to page encourage and call.

to that development, to activities results performance factors Bill. refer expressed our presented Forward-looking our statements filings now or may forward-looking those this plans during and today's from to for research to materially implied hand could and press related financial in be outlook or these product I'll statements. And risk regulatory actual release Please commercialization and cause call. over differ and SEC our it important

William Meury

and Thanks, year, and good of operational priorities. X this the we outlined beginning strategic Alexis, everyone. In morning,

core, launching is the means third first securing the NDA the and efforts, KarXT which continued XXXX. build to of in maximizing the submitting approval FDA quarter, KarXT through our in The successfully value development

our organically to to is organization. company support expand capabilities an inorganically. second commercial the The third integrated and our and transition to operational the to needed scale pipeline R&D is And and the build

I on X, X excellent today can here in sit May areas. we've we say all As progress made

profile our a the KarXT positive X statistically and KarXT start demonstrated KarXT. from significant we than reduction updates positive effect X.X mild clinically In consistent consecutive X.XXXX cholinergic for schizophrenia at Cohen's the moderate X effect side p-value less as the efficacy and at well with week X trials, EMERGENT-X, registrational quarter, trial, clear expected, schizophrenia. was development of were in size and or score in which p-values. substantially point total and severity across In evaluating announced activity the transient consistent prior and In looks the our with studies, PANSS meaningful to a the demonstrated and a d PANSS, tolerated now side regulatory trial whether Let's KarXT with trial, first antipsychotic in mostly X.X. KarXT and data safety with generally effect nature. a generally important has third effects,

completely with leading Just as we important very date the see burdensome many generated antipsychotics. data by somnolence, should the if community and weight data exploratory CGI-S, well safety the a is side can for overall these month, of EMERGENT-X The as medical These and the to to outcomes from psychiatry EPS as common impact relapse treatment analysis received that which compliance, sign gain, and of treatment reduce schizophrenia and didn't at be KarXT and to be effects and are lack be results cognition atypical presenting forward new data congresses schizophrenia, well negatively in the totality differentiated to can additional be approved. of including and evaluating potential new meaningful such this pharmacological vital endpoint and rates efficacy patients. We EMERGENT-X KarXT and hospitalization side trials. for effects of in AE as EMERGENT-X for look reinforces patients

be enrollment great both information are long-term support designed to garnered trials as that valuable trials last in up progress plan We'll only effect of of end not deal in EMERGENT-X NDA, the Phase enrollment NDA. studies, as for evaluating for the at data to from trial schizophrenia. pressure of for evaluating advancing in provide KarXT our expect addition this very completed the this significant line fourth safety education. and the EMERGENT-X from XX-hour contribute We date, blood and to can our we EMERGENT-X made are our data is EMERGENT-X, KarXT our long-term and EMERGENT also to XXXX. Outside ambulatory XB we EMERGENT-X, well open-label anticipate year. the these well underway. In to safety the trials year, numbers overall XX-week top wrapping program, initiated to a on safety quarter. Both enrollment April data in in medical trials trial exposures share the we There's of quarter by pleased the of but and

meeting our we target the our assumptions FDA quarter the front, quarter, pre-NDA we for regulatory a third continue timing, On related of and this key which the package NDA our and with submission reinforced year. had to to positive data this

minutes meeting XXXX. appropriate. to in organization getting for will way this the and In its is potential the formal more preparing expect month, as of approval meantime, and on ready submission KarXT well our half the provide we the We of second later information

update KarXT adult outpatient by our in care response to Now and that open-label XXXX. optional includes of This to of line data ARISE our guidance adjunctive which an we compared of treatment. The the trial on now second half the morning, the evaluating therapy. turning trial first long-term program evaluating evaluates of and the This of XX-week trial second enrollment. as its treatment who an driven we current XXXX, an previous ARISE, and placebo standard indication, half is schizophrenia extension safety KarXT to respective that from X-week anticipate of is to a of primarily inadequate KarXT their efficacy top program, X the an in atypical adjunctive announced Phase top experience safety of

teams operations measures Our clinical development several clinical to enrollment. are implementing increase and

Serbia of will sites coming the top these XX so active and XX the ex-U.S. activated or Bulgaria than activating we're week United sites of process in of more last on and weeks few in and A as in existing are more of the be sites recruiting the First, States. months. in ex-U.S.

reviewed clinical steps and have execution been includes This up changes reflect site and trial and to technology efforts. in of experience. been all changes made manner patient and this communications, third, operations, a budgets site and enhanced additional timely have in study where quality. recruitment shore Second, important, Timely site completion to And support. is necessary to without support physician the compromising we're taking adjusted necessary marketing

on Alzheimer's in is psychosis expected XXXX. efficacy of in have there underway the trial studies, trial clinical actively our via trials and ADEPT-X a enrolling XX-week withdrawal ADEPT-X, disease for open-label year. which ADEPT running acute briefly track. and Data treatment. and second in half on Now X consists KarXT no and ADEPT to are optional and which evaluating we in which program, our of expect FDA-approved is and ADEPT-X, these ADEPT-X extension is randomized The program, ADEPT-X, the from up safety ADEPT-X patients, remains

in year. an KAR-XXXX. exclusive met forward in-license in on of building treatment preclinical Strategically, We validation diversifies it with pipeline. and the And our inhibitors clinical stage later This development more agreement early this expands represents in of February, our the all lastly, novel value criteria. we important KAR-XXXX pharmacological In Now clinical a portfolio. anxiety for TRPCX/X our and look planned anxiety it mood Scientifically, completely transaction lead global future. TRPCX/X the models. candidate details announced for disorders, to on could for mood sharing to company psychiatry and including source an and approach program of be

our and capabilities this excellent progress operational team. our for building We've priorities made year. to Turning

call for to different regional to over place do hires. medical runway in including others. to publications that planning, Troy already Kane, those meetings cash years Officer, turn a we of filled publish exchange groups at experience Our our XXXX of like the plan ahead. to We financials launch review several great market engage effective access parallel, Commercial thinking quarter and such in develop our staffing We've posters, medical who to new These as we're Chief plan and Alzheimer's. We've and in team it. I'd about support and successfully includes Will are this and community expanded teams activities and XX over first require pre-commercialization have affairs XXX our our on important schizophrenia brings key and neuroscience, and how XX articles. scientific including payers efforts medical deal expand the over with national roles, among in the and our to

Troy Ignelzi

and quarter an overview financial followed the begin of of remainder results Bill, billion XXXX, first XXXX. and with In increasing outlook that million, morning, our March, follow-on position XXXX completed cash of and XX, as public cash for our billion $X.X I'll resulted at offering the you, current Thank a $X.X of everyone. for proceeds by good of our we March XXXX. of to in XXXX $XXX.X from the end position net financial

We current of end operations our the cash the to XXXX. fund through expect

employee stock quarter period, was upfront candidate if $XX.X were XXXX, million $XX.X drug were NDA as to an million, launch Goldfinch prep the commercial X ARISE increase quarter schizophrenia $XX.X EMERGENT, and TRPCX/X higher by was which million ADEPT $X Importantly, than increase of prior by channel half was after with interest slightly which commercial of license fees, in by compared expenses activities, $XXX.X million $XX.X employee of our of in least second to first Total compensation expected stock-based sales the and revenue Zai for versus versus by prior higher headcount base million clinical income an was extends cash year associated an expense. G&A and the for years operating licensing year in runway payment the headcount R&D first driven well offset programs. million quarter million, at KarXT year the the the million professional Labs. and for driven primarily prior. Operating supply $XX for expenses related FDA. primarily to in the of increased clinical the $X.X expense supporting Bio's our period, increase in approved $XX.X expenses less again, million expense. compensation as activities, the first

modestly remain on the and for We expect expense SG&A the quarter-over-quarter remainder build relatively commercial to R&D and infrastructure. expense a to year increase basis we of quarterly capabilities to for continue our corporate as consistent

million up range financial million with which in to stock-based the to compensation, R&D we which in we range $XX between also includes full year expect anticipate and We to million are between stock-based up $XX operating up our $XXX million, compensation. in includes reiterating $XXX guidance $XXX Of includes stock-based million, and for noncash expenses this, to SG&A overall ranging $XXX between compensation noncash expenses million million XXXX, previous expense. $XX $XXX $XXX and noncash million and expenses which to million,

I'll be in OpEx it similar to that, expect with We total decrease a XXXX a SG&A. With corresponding hand back to and for in increase XXXX Bill. to R&D

William Meury

Troy. Thanks,

to well We're team positioned really perspectives. and As and by we've the mentioned operational capitalized year and encouraged from the strong start a progress I and forward future updates the business. And well earlier, management I priorities, made expertise development, needed I'll that, with regulatory with to begin to strategic look to against it in-house programs execute operator and over our X turn Q&A. across our I'm providing the to

Operator

And Instructions] Richter. question come from Salveen first your will [Operator

Tommie Reerink

Congrats progress. is the Salveen. on on This Tommie for

Just also, could what And one remaining out pre-NDA came of the you cognition help into meeting here. What are the gating data? this the meeting? expectations here? And items on frame

William Meury

Thanks on it I'll it. for the Andrew expand question. answer to Miller ask Yes. and

this to submission among it and As our meeting, analysis to to was largely meeting. productive It procedural. things. reinforce several data positive related and very communicated past, our in the it confirm, plan, relates pre-NDA wanted We key the other assumptions was timing, and statistical we've

of submit XXXX. said quarter we the track on we're to in remarks, in opening our As third the NDA

in expect at the there really the the surprises meeting. we meeting month. minutes formal That of So all at have end were being no to the said,

But one to major need EMERGENT-X. was meeting no -- that and It and of outcomes. look by feature May. Look, full at FDA-approved data, ASCP will is analysis leads a of Andrew? clinical the to encouraged something what EMERGENT-X it focus I want it When We're It's unmet net-net, development it schizophrenia. we an I I we'll the at next here there's into and that right comes several a positive. be now, quarters. long-term that predictors to and it's was believe see. the information work, cognition As me data, months over think is the Cognition additional high. in relates the treatment the share functional of do essential of

Andrew Miller

program. KarXT endpoint quickly that's available information the an this I to just that. we to think mean when obviously, and xanomeline our data, you as exploratory are xanomeline I arc But and to from all with us biological of encouraged Maybe across from from the part of EMERGENT to of the look perspective, part I historical date Yes. and the KarXT preclinical add is to rationale the study. schizophrenia studies cognition studies as around data in the the with Alzheimer's think

month. presenting end more look of forward that the here at we the details of to So

Operator

Our Matteis. next question comes from Paul

Paul Matteis

Paul -- I was pronunciation. FDA the Matteis. your interesting on an That on one That had was question meeting.

up review, I confirmation and that Just approach that in sort -- guess, as FDA? did plan during with the acceptable to it submitting the to at ABPM some your articulating just update you come whether of guys did then, an data result? that's those all do And data you strategy get that how safety sharing the

William Meury

Thanks, Bill. answer Paul. I'll ABPM. let Andrew It's question regarding the

Andrew Miller

Bill. Thanks, Sure.

to safety XXX from as as that QTC, Of our current course, idea ABPM the be I with be part consistent overall and the of pre-NDA study the all development the EMERGENT studies. well data all obviously, vitals our We our course, specifically a have precedent present the meeting, study. reasonable ABPM We, based it's of would consistent such Phase-X I with a think strategy on safety studies, as the renal reasonable clinical of that the Phase data update, clinical across of in plan. Really, plan. do part discussion, discussed additional our we as program of with assessment of which would that's variety day as studies ABPM presenting really trial, impairment think a a hepatic

update. of will day really reasonable all data So do data an just alongside to safety that that XXX enhancement other to strategy provide think that's set, a is the complement at set. this we that And safety come data that a

Paul Matteis

-- any the ]? how comment on on [ you articulate data, that's those just guys X will And

Andrew Miller

we of sort the think data gotten some potentially endpoints. point. line I endpoint this mean specifics that, key at of haven't primary I typically, the with would into at secondary top or Obviously, be communication release

now about manner thinking information But want keep in that. once get we a we obviously, timely the we'll it. So to receive

Operator

Jessica from comes question Fye. next your And

Elias Lenard

recap can associated Nick in adequate particular, in this activities of that Jess. just ahead the mentioned of are of on time? this, remain that potential terms kind data with And you I data, for kind some to filing, is it? you track but EXDX. on filing on of This exposure recruit I mentioned the NDA the of you amount ahead know like of But of the

William Meury

almost communicating gating -- from perspective Yes, respect factor. With we've study, and that for to the to a safety it's long-term year likely absolutely. the think really safety long-term data been is EMERGENT-X EMERGENT-X, the with last I be a

a I that status factor amount current in where we tremendous projections that's recruitment year, I cleaning quarter now for as certainly up submission. approach go it that think, shifts Obviously, the are obviously, submission. writing that we think really all submission close we're analyzing very do of anything forward. that we a at our hand a into limiting in information include the retention to our recruitment X perspective, And position from about that not where goes there's data, of from and data this as

Operator

question [ Gerberry our (sic) come will And Jason ]. Gravy next from Jason

Jason Gerberry

It's One Bill. for Jason.

implications start of make of navigate in of with just indication for imagine differently IRA. about and And to future product clinic. CNS the Just stacking that, advancing other ADP you is of where in way, the pricing drugs. muscarinic common -- interplay does you're perhaps you them sort currently that legislation through a the into beyond the IRA is think any programs and agents This playbook the the your to curious thinking about IRA curious targeting sort preclinical I'm how sort drug maybe I exposure. could KarXT development tip

would just can color that you any So great? on be provide

William Meury

you're think holistically. of question. And of IRA biopharma component cycle it's the management a to it's and to you the about will I a is I portfolio have think from Jason, course, it. if any size. of upfront, hide good company the say life Yes, just I do a difficult think running IRA

drivers an clearly schizophrenia of could relates approach adjunctive it of in indications change X I the treatment be and of As includes, on we driver. schizophrenia indication, and important primary which KarXT, will to be which the drug, a as have fundamental served the value value. course, think That potentially

we're we we think broadly and psychosis. There indications are have analyze. other to I in examining, that continue speaking, psychosis, Alzheimer's

there's into bipolar, to Of could there's should early as And of autism, end we get interesting. course, those they mania we'll continue analyze you focus have opportunities year, the to and that aspects be Parkinson's the also come XXXX. closer of

of I now think broad community. in we adoption have could the result an certainly right indication set that psychiatry

it And concentration about we it the reason be Medicare that will roughly psychosis relates more relates be an Medicare the advantage in that big you The D. into to even indication I outside if us how while you don't LIS can't does KarXT of away of also to have Part Part-D it, could context deal can consider for which channel, As of it. it the KarXT. as from there's is shy great And XX% not the IRA, a think of the component, of risk would fact an think in IRA. just utilization Alzheimer's Karuna an shift for

And think the our but develop area diversification, a our just of we revenue, I portfolio, sources As like mix. also in about growth do of payer compound not by and think terms as we'll anxiety, where more that we while the just about with or of early, would at information that XXXX, it's the still depression you end there into IRA. have the actually impact from year, TRPCX/X, move much early is therapeutic and

I carefully, financially, where then, Jason. opportunities, best take the into investment. on just our about all course, strategically the we return Thanks, is consideration, So and think of factors these scientifically, obviously,

Operator

And from question comes [ Bitritto our Neena (sic) ]. next Britton Neena

Neena Bitritto-Garg

that you're of encouraging, be you -- here. bit weeks would Can talk are in impact indication plans little additional and going data the the but for I to you just next to NCIS expansion? how about encouraging present would back indications to us through consider know to you on just going the I great. it's that did on plans be any what data going formal details know of walk to your a said kind conduct curious you So, just couple the additional cognitive the

William Meury

that can Andrew take question.

Andrew Miller

just the maybe I part last first. Sure. take

on have it'd be, the of obviously moment or going of in of as I plan rationale and things. potential think, KarXT. this have some I mentioned, there's Bill some at exactly comment lot a for sort them, different to we think data them mechanistic we to is other of premature And be indications existing initial what

And of in the cognitive And the so we're EMERGENT-X from that EMERGENT-X will as putting all in that certainly, cognition and schizophrenia. see together with to respect that we mix. part play in a data

EMERGENT-X. cognitive They specifically of at on of were But the recruited PANSS that recruited symptoms. And In EMERGENT-X a some the EMERGENT-X. the as from on allows is the and EMERGENT-X, course, I assessment severity is of positive individual not the same duration completed dose a focused updates treatment were should in same the did aggregate study. the that One and look of is randomization, basis us see total to X data analysis of cognitive that to interested itself. groups. EMERGENT-X, battery that studies. of and impairment. terms sort what around basis was but in on of the between EMERGENT-X of design studies the We studies EMERGENT-X of Yes, overall the in different group you an we as the us all obviously used Again, and make the is data. We're identical EMERGENT-X think to well expect type from study

subset controls are vision see of and of with used again and at below we so cognitive of respect patients the EMERGENT-X performance who to is the we with age, that EMERGENT-X standard the normal specifically look on mean mass, to do And with things on the EMERGENT-X in battery one the that you'll study. this

near to to results across be being would And specifically share if again, specifically at target here future. at we details the able you more looking in the so want look patients were that forward being you look encouraged enroll, And group the idea to to those the cognition. by We're groups. would

William Meury

you are near introduce even And of really is one for KarXT appear impair on more EPS, any cognitive KarXT is thing that about does add, survey impairment, the the of weight DX problematic one psychiatrists impact not current I when think to hear Neena, antagonist community effects psychiatry impact is we thing side we cognition. to would commonly gain could if term, that which the or what know than patients, you frequently functional or outcomes. in which

So at we have cognition. that's impacting not minimum, something

think important. signal the launch, look there. I a whether certainly clinically, or experience effects, at you very But is pre-clinically real-world things the pro-cognitive of for this there's also the

think should positive. I it be

Operator

from comes question Chico. Laura next your And

Laura Chico

little still is appetite changes William, that And then What's the are some if challenging. schizophrenia Europe you dynamics one posing speak could the KarXT imagine you follow-up. trends quick made for trial PRV And And about for headwinds I'm a on securing wondering in are there a you're But bit use filing? the structural disruption phase. recruitment comments making. Eastern more your clinical in in I other about study recruitment?

William Meury

Yes, start second the question the Andrew. first probably and over question turn I'll with to

procedures KarXT And number that with I'd As different get to a path our we and the of looking the to it say there access FDA. reviewed can expedited most relates are under possible. approved we're PRV,

to Of learn here and the days continue we'll make is period. that We'll market to a course, the appropriate at about time. important. the priority But PRV review review clearly, after XX evaluate decision speed a actually and the submission, shortens

I exhaust to think do every and that's we'll that. obvious, possibility

Andrew Miller

a perspective, to of same With same the large competitive with part patients competing think for sites recruitment, schizophrenia, factors living in specific ongoing moment. that studies respect you're that the this more at lot to are Obviously, studies with in Yes. the a specifically there's from I patients. don't around

into run. We've of to EMERGENT all of clinical outpatient different obviously ebb and we patients NDA any study don't a from out submissions over sites both EMERGENT-X sorts been includes clinical next be study that to across here protocols, for factors and support noted recruited we I able frankly, we flows manage, that dynamics myriad EMERGENT-X which think, the very anything well, specific time. successfully of in as by would factor the specific can't they'll that that think But a execution So quarter. point. have schizophrenia this There's go that I program, with point studies to, execute that every inpatient the provide and at

So specific think out I this don't we anything would at point to schizophrenia. point

Operator

your And question comes next Olson. from Jay

Jay Olson

the the of on you schizophrenia size for and progress to also mechanism monotherapy Congrats all the therapy talk for about need you the thank and update. adjunctive commercial and Could KarXT as the atypicals of could setting with for and dopamine-based of how the novel synergistic schizophrenia? adjunctive compared unmet be therapy opportunity

William Meury

it's Jay, great question. Yes, a

a X set to are of DX receiving Today, estimate patients Just schizophrenia bit. so antagonist. the to XX% XX% we stage with little

I best think the the that need for of here. probably is example, unmet illustration

why In the intuitive we're terms which are mechanistically to doing is it's different psychiatry, study. to probably completely of a and adjunctive use compounds psychiatrist complementary, that X

in you If Alzheimer's, depression X/X example, treatment at more a in market. or of options or adjunctive they to look areas, other in for up garner can

to were is to of on, use positions going are course, approach numbers early and pretty the be class, I sort class want accustomed psychiatrists approaches it's to patients do a schizophrenia the this, antagonist. going that the you they're antagonists DX than lead polypharmacy the that behind I so on top muscarinic think And of for clear KarXT pretty we're if opportunity substantial opportunity, commercially. put adjunctive significant. a add? in similar are to of here could using pharmacologically to then, DX X Andrew, were treatment believe you really do different, more If

Andrew Miller

subtherapeutic substantially the perspective, the of sort months last namely quickly, with and of combination representative pharmacology, the pre-clinically. and think aripiprazole where Obviously, of we also scientific be or program. and opportunity ARISE to that in so, part We've data add dose atypical exploring benefits And of, preclinical conferences of dose see the at from a pharmacology subtherapeutic a presented complementary. the there's models to scientific is We just it at use you Yes, over of the looked that do take just antipsychotics obviously, primary synergistic true can as XX psychosis. for risperidone that we're different. xanomeline

obviously, stage in nice at that. so to human want this to blush, support think support But that first data, it's data to I we think and I ARISE albeit idea. the intuitive, And preclinical some clinical trial we generate scientifically, at have

Operator

from question next comes Amsellem. David Your

David Amsellem

So see or couple. just clinical priority that we thinking about Can bigger of cycle to And how talk a secondly, a commence a injectable about How about priority management, in big once-daily formulation? might you when life mania, long-acting you work a what's then that? think as you're is? getting a oral

William Meury

David, This thanks. the question. is I'll answer Yes, Bill.

certainly very I mentioned that earlier, larger to relates already it indications mania, at come X and think as will to XXXX. mania, the early well. we're additional a it's I And mood As developing. it's part something There's end of of of the a analysis the beyond Certainly, we're know it at that seriously. that into psychosis looking anxiety focus, I fairly market component year,

additional quality. making path, indications and be decision. NDA thing but the our right now We of in that intellectually single an will a it time We right operational that. And step the relates time, as have a lot sort We're than it's submitted but on the highest more the ensuring do focus well can is is one now. at next certainly our down plate to on

We have those types of bit and work about do to investments. a little think more

either/or the opportunity any the if think dosing it's dosing know an don't an product. if LAI, to there's it As of for QD I improve to I relates

we, necessarily as Andrew psychiatrists weight new formulations. as I not And to and a You do better don't dose of an set I safety different dosing psychiatrists. don't to of at anything bit have want through we'll impressive. I efficacy over the impediment. but program this we in the trials. efficacy with regimen want is a want is I I'll think patients X type I opportunity take dose And think will advantage set course, as see high fairly the regimen. pretty product have of we have and creating regimens a value BID also with They gain, else, here a upper different a X,XXX titration sedation. And of the less and right a or a and EPS commonplace LAI? now and it. product with that range see very little what to and And data I convincing Physicians think think to to get end But if I of want it. don't out dosing formulation, dosing flexibility the talk bar. Andrew, relates KarXT as EMERGENT to say, just we've about about more gate, turn an do a KarXT, it you minute. also and

Andrew Miller

I in Obviously, oral the that I to a the to envision perspective, a U.S. portion of a continues be outside bit. used the something is from us. from U.S. Yes, medicine. sure. growing being that a as you well a small the the that's portion but as obviously, market that Due overall switch to something of really of as little interest schizophrenia. speak mean, to timing can prescription in LAI

hopefully KarXT and of can out patients helpful gate The efficacy oral perspective. an And and perspective, from is the to the focus that be so safety is products very from our established. both really obviously, tolerability overall something

opportunity able formulation. LAI a we're extent confidence we that potential in, that, which certainly have will an the establish And for to do

push on. to hopefully, the And in that that So position we'll we be about actively if updates we some provide into development. clinical it futures are intend to how not a the is working something

Operator

Suneja. next comes from Your question Yatin

Yatin Suneja

for maybe of study? about and don't it are one question the us ambulatory me. scope the what that I talk for Could you to risks on and clinicaltrials.gov study? key Just the articulate just see size

William Meury

a I bit. to little that can speak

is It As clinicaltrial.gov Phase a study you ABPM require listing. noted, the a study. X doesn't

We group. KarXT. patients. of have about of details a some arm spoken we has previously in can There's identical EMERGENT-X. study. high-level is X use is some that X-week dosing EMERGENT-X of what study enrollment here. target to and KarXT placebo recap It's The The EMERGENT-X, that dose It an of the of XXX no

the being conducted ambulatory to pressure measurements first for then able hypothesis a be out additional titration endpoint dose course drug KarXT month. We there's put average That's we statistical Cmax if of use patients would how levels consistent EMERGENT-X X-millimeter you is endpoint. that that a already a EMERGENT-X and in is the endpoint. dose, So data study. successful XX-hour on respectively. The pressure look we XXX/XX at a the primary if primary to in that ambulatory put we to and vital data that will as than same and ambulatory the and got EMERGENT-X take monitoring blood since But EMERGENT-X assessment, next flexible EMERGENT-X, Again, continue X-day study, change blood if after at studies you pressure EMERGENT-X, really EMERGENT-X week, thing the on of make all even from EMERGENT-X, XXX/XX blood indications we've less and data opposed which and the of the EMERGENT-X be FDA we'll and in here are systolic with for from across guidance. out baseline per the

say, So of QTC program, data drug even more type what across really study, the study this the in definitive EMERGENT-X what development gives typical you why confidence a ambulatory already we that's doing is a just your so have we've that already a confirmation that bucket. way though that's put and the same program, a the which it way, have we between in kind assessments But and similarities you that as Emergent-X, that really EMERGENT-X dedicated same we at would do entire seen. ECG clinical so in thorough given us look of far,

Operator

from And your comes Myles question Minter. next

Myles Minter

pre-NDA safety outpatient NDA pretty just FDA's Or Just it out encouraging you laid complete that you've morning did an there in things you the discuss filing? for as the pre-NDA much data? of on that the are inpatient. mean regulators what the And got meeting, the as on data before is few well also meeting past does inbounds recommended a is to other just want -- definition you're the this valid waiting

inpatient. in in bulk of now generated your Just has clinical the the been package

William Meury

but preparing Thanks it third of -- it's the quarter that and we had positive then the to for expected people entire submitting me just need to what get define XXXX. course, team key for the in lines. reinforced of as Andrew? And assumptions I'll meeting an Great. the no of between would roughly be, month, the the meeting as for the question. is that at NDA there's We, simply we minutes it and have reading meeting was the of the this submission. end reassuring this we simply preparing

Andrew Miller

had that. the confirmation think I forward. really plan was of it And it put already really to we preparation spoke think a that Yes, I

good So I a that perspective. think feel from we regulatory about

William Meury

question? repeat And could the you second

Myles Minter

Yes.

question as inpatient is data, your you package as whether clinical they specifically, if outpatient data of the the see wanted just majority the knowing setting. in asked regulators of the to Just well inpatient

Andrew Miller

speak to that. to Happy Yes.

So mix studies. both is emerging of a the inpatient and obviously, outpatient program

are a of Importantly, not you It's studies anything placebo-controlled X-week EMERGENT-X, acute which have to the safety psychosis and and EMERGENT-X, are to receive EMERGENT-X inpatient. XX-week of EMERGENT-X KarXT. patients outpatient. of and psychosis in randomized EMERGENT-X, placebo. portion acute That's reflective completely studies that reflective them the are unique with fact

the that studies. acute standard for is psychosis So practice

look previous current to been the registration of back only years placebo-controlled paradigm of medicines. you If the is XX support to study that the type that's used over atypical inpatient XX

specific reflective So the it's really to nothing KarXT. clinical and setting of design,

approval submission type the have so that used last and said support the And been XX the years. data approved to data been of of NDA type exactly our way, support the we're providing really antipsychotics the to submission of is for all another of that's

Operator

Your comes next from question Jason Butler.

Jason Butler

just terms your payers ages introduced -- Just and you in therapy? And a mechanism any on a there prior patient quick adjuvant blood payer are thinking Is a little on context enrolled on study? bit the of, about versus the into what schizophrenia is into the how engagement then about monotherapy in of or limit being limit pressure talk novel can real for authorizations being follow-up the study. example,

William Meury

question. First

Andrew Miller

Aging agents.

William Meury

ahead. one thought I first. you that might with deal sorry, Yes, go

Andrew Miller

start the one. with we'll payer Well, Okay.

the they are we appreciate been reaction I novelty since this be there it's of a They prelaunch started interactions so context in and early class. able more pilot have collaboration obviously, And that So the detail our them with clinical the per overall decisions allows mechanism a building about would been to which discussion access in coverage. to and our they have also the long market to it the of more later we'll in a data, some share to initial them with novelty with affairs enable has the one. positive us detailed in access is account say because payers make team. put this as medical that team, year

where news, utilization moving encouraging those quicker added standard market of to the some And as in so, be initial put reduce authorization some the steps think there review clinical cetera. mandating reducing Prior it is et I the this by new But hurdles potentially signs and particularly encouraging, or [ times such at techniques, pretty management psychiatric drugs. legislatures profile, the are will states context of state total but level, in through are ]. for step are PAs

play recognition and to payers. planning more we for I monitor that and think that. illness, But engage terms to commercial in our the need do there of both mental society we'll we, how And that and launch with be so serious will out patients seems a as government

William Meury

or a at if for the I the there's currently mental of would And other and that real I rates, quite formulary available health, the the you make that the is add look think I balanced a high. branded coverage dialogue the is antipsychotics, which between they're would atypical area still conversation point companies And in positive. payers

pharmacologically covering looking what products. something And between the have they're with You're to deal of dealing and formularies at we XX% with is we'll actually XX% different. these difference what that is

DX I a strong X payers going coverage for problems can access not be secured, that be think which patients does the at innovation. we're Karuna a create the is of XX market, its achieve rewards able for time, antagonist to there's that a for at if price for and and budget physicians so likelihood And to a same

achieve, I balance think our aim. we can that's and that

Andrew Miller

have of XX of typically the ABPM Yes. just XX focus at XX you about look That XX. the between how also they ABPM study with typically that's the patients enrolled allowed That's respect and average of EMERGENT-X respect done, patients of aged studies ones be the to between to the that vital age tends XX, is to more the with age among group age to the the group XX. course, of idea enrolls are that XX to an add the I Schizophrenia, including with in signs. would really XX. And When that And with to study. EMERGENT-X guidance. representative we quickly to consistent also That, representative of and it that, program. XX deviation up across all EMERGENT-X, studies, EMERGENT standard age

end that patients And age so a at fit that and number the of vast to XX XX range. the lower range, into upper majority of end relatively small

study, distribution ABPM EMERGENT-X, to similar very a So to have would expect EMERGENT-X. and EMERGENT-X we age the

Operator

Your question from Brian Abrams. comes next

Johoon Kim

Brian. for is Joe on This

of to talked atypical. have we of and versus the to So excited potential KarXT several physicians, the they all differentiation about cognition were

there ways are to over that Or KarXT's relative if time launch? for advantages you can or do wondering the additional initial potential beyond and a Phase-X presentations. atypicals are analysis studies Can there lines smaller highlight that just So work? conference cognitive to potentially you do

William Meury

Yes. Listen, think really I it's a question. important

And answer and be, commitment in registration your yes. larger There -- we work, the is There course, which of is short additional that you also publication investment. could it purposes, be have clinical I then, analyses be would a trial. also that are question said, do. do. as for investigator-initiated And could you we work think additional are there will to can that

different. ever important. If effect think wasn't I a antipsychotic every those so need But be we've unmet about are so are think conducted this clearly, medical in that and of has few for board answer, important, and interested the exploring would Andrew it. in an is pro-cognitive advisory I course, this can high, ever we've all more And done options in we. make the of every comments community a the survey is

Andrew Miller

data similar to EMERGENT-X do well. we studies we ongoing have opportunity collection as the obviously, EMERGENT-X, Yes. and what part analysis did across I across mean I the and think, future of EMERGENT-X,

the data EMERGENT-X agonist what continue we've effects details the the that or available that we So looking the story, again, really xanomeline come and to nicely the talk here the the And way to to all more MX that other think at reinforces the about the continue I that month a pursue antipsychotic to we idea spectrum understand pulling of of recent be that have. schizophrenia most of the KarXT additional of populations. Again, that at as kind will benefits I of sitting for year was dual originally able developed Bill I was demonstrate be and an best this as continues could think it's effects in story, of pursue respect the EMERGENT-X, there but X. very Obviously, the deal, into information or original want cognition, a together that potential to hypothesis. lot of pro-cognitive end to cognition think entire about the around MXX across said, sources to to of it agonist with broad down next saying, could piece be think

Operator

come question Marc Goodman. will final your from And

Guofang Li

Marc. the Rudy is line on for This

for Regarding DP-X as client the study, XX-week with CMAI? of maybe remind duration rationale Alzheimer's that struggle why the randomized us you for is select the for the Like the MPCI And design? the we X psychosis and how select can time do a parts? indication to primary XX-week

Andrew Miller

last speak part to quickly. that I And Yes, the first. maybe can

we So collect core hallucination our portion with really related, primary be, agitation treatable, with core respect I'd effects. Index, somewhat to the --an as and taking primary of aggression, the of advantage the part delusions and take focused ADEPT-X, which endpoint. psychosis reflects to not are agitation say, version CMAI, but medicines, endpoint data that the really the can sedative ADEPT-X clinician on psychosis types potentially we NPIC, CMAI index their and of which is that the opposed of opposed Agitation to as as ADEPT-X. different That we neuropsychiatric treated that It and around a is the endpoint. of Cohen-Mansfield collect of isn't aggression as

withdrawal well placebo. effects. Obviously, does as enough have saw that. we as more when of protocol, on couple weeks resistant randomized rate [ the a And the EMERGENT antidepressant using given design. it study, It of on been very the The study psychosis little look literature, and long that. With treatment. And We a labeling. XX of a similar a for respect medicines. sufficient there nice time response sufficient of study that's group, amount sort EMERGENT-X, results the ADEPT-X complement substantial towards to clinical or then where effectiveness used X as to more that commitment EMERGENT-X. placebo double-blind study period, placebo-controlled treatment. a number rationale ] that's then to common relapse withdrawal a used allowing more a typically depression. therapy the really the of marking [ It's in benefits It require each Lilly out of actually KarXT as the other. to is provide more of of design you than substantial early that's that of is XX-week sorry, about and think than have first EMERGENT-X really randomized time level randomized original to for a potential So period withdrawal of substantial you at those It's EMERGENT-X as opposed We ADEPT-X is parallel events a being to in to approval to commonly as or see longer something can is Alzheimer's tends XX ] a schizophrenia think design enable support maintenance to to believe weeks pivotal be design open-label of weeks

it's so those of primary that analysis. really the And the relapsed endpoint is basis events

we little chose. the fundamental just those the studies background of that's on time additional So a kind bit of of and construct that frames

So I appreciate that question.

Operator

remarks. And over final Bill we to President CEO, and will turn it back Meury, now for

William Meury

our everyone joining the to progress. on you want we call, look thank and just I forward giving the to future updates in for

Operator

And call. this today's concludes conference

disconnect. now You may

Karuna Therapeutics (KRTX) 4 May 232023 Q1 Earnings call transcript