Arena Pharmaceuticals (ARNA) 6 Aug 212021 Q2 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Arena Pharmaceuticals Second Quarter 2021 Update. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like turn the conference over to your host Patrick Malloy, Vice President of Investor Relations. Thank you. ahead. go Please

financial and hope everyone press for us QX joining we program Good had thank a We XXXX our announcing you this the and chance today. key issued updates. afternoon, afternoon you results to release review

on Doug Amit Munshi, session today's and Vice of Manion, Officer; our Chief President and President Development; are Executive Executive Vice Commercial Chief Lisicki. our us be Research Q&A our Executive will Stelzer, Vice call for and Chief me and Executive and Joining Laurie Financial the Rob joining Officer; President President Officer,

Before we expectations, pipeline, those uncertainties related begin, and the be projections remind its or beliefs, I'd involve about risks statements and potential and on impact uncertainties events you including plans, business. that making risks like our financial COVID-XX results, our that we'll to pandemic timing to goals, and our of forward-looking future

press uncertainties cause assumptions, Forward-looking to description may could and statements. risks update our information Arena, release currently these we and statements to of our be certain control obligation disclosure A documents. these latest earnings some statements. All could involve based actual materially of forward-looking available in found and any disclaim from be on these our which risks SEC forward-looking statements to are differ and results beyond

Now I'd like Amit to over Amit? call turn the Munshi. to

and the ADVISE to in you open review program release everyone QX off provide on press some call. had today's to to I'll through important the announced Laurie thanks more and chance I Doug financial where then updates. then jumping comments some hand and will updates take for the performance. everyone's we'll Pat, issued the very this and label we data Thanks set, a walk detail, through initial we afternoon presume

prepared the on remaining spend time the we'll Q&A. comments, Following

Arena with Manion. introduce GlaxoSmithKline begin, companies to clinical XX President and across with Research of executive leadership appointed Dr. our Development CEO Doug to to of Kleo Myers DuPont, Executive continue we and Most our as of newly Doug instrumental global in Before experience organization. we into as experience, sustainable and Bristol Vice be immunology recently, like formally a research Merck in I'd development, Squibb. will such transform and comes Head therapeutic and Pharmaceuticals. extensive drug years experience areas including Doug's he was

been Turning 'XX, following our early past strategic to over you've the course story three critical out to we the X, Slide of you'll Arena if principles know that laid year, the growth. long-term in

support grow and long-term selectively vision we our business. for to pipeline to First, plan the our prudently

continue will of Second, the in pieces success. we will third, maintain to leadership continue advance we team out commercial put all culture success. And place our that to the and grow ensure to for launch build

of all forward As three these we're on you see, progressing can principles.

took week, to core now we agreements the our Slide within Turning our pipeline last step announcement first an therapeutic with option our collaboration important to of stage Aristea Therapeutics. with and bolster X, mid areas

XXX of deal in strong GPCR over in by agreements is an molecule small were for potential our our course us we pedigree current chemistry and all presented characterized to prior the to first, deals. of We second, year, high therapeutic in area dermatology de three well over financial licensing pharmacology; alignment with a few that bar molecules opportunities three, program focuses checks cardiology; with past and evaluated antagonist within that criteria; the collaboration exposure with have these small of Aristea Very AstraZeneca RISTXXXX chemistry limited boxes. oncology. of and The was and in GI, essential and CXCRX the risking. originated met oral

is and an asset exploratory of IBD from see the ready hidradenitis trials. in with to explore through or a couple and potential to mid-stage early our clinical can development small opportunity Phase note a the pipeline, PPP, RISTXXXXs and molecules a deal IIb HS the slide, investment Aristea to you is As suppurativa enhances based IIb a other to library important palmoplantar on in study RISTXXXX acquire option or is outcome upfront pustulosis of that grants fiscally includes this What of that sound us and a structure nominal supporting trials. CXCRX PPP that the Phase

X, share through made progress I'm some in to Turning important we to Slide program happy Aristea addition, acquisition, pipeline the updates. the

studying receptor colitis. are global ulcerative SXP modulator As two you etrasimod a in studies of are most of aware, Phase we three selective

XX on As XX we ELEVATE enrollment in ELEVATE hand ELEVATE our Today, trial announced we XX for as ahead provide that well And I'll with XX of to full of to the remains Doug reached that's on expectations. QX UC January or to other line in of details etrasimod our week off it has etrasimod he additional programs. Doug? excited in readout 'XX. top I'm this track reached study, announce enrollment that extremely full year, data that and as

to Amit. you, the to to OASIS will everybody. And consistent hi, Phase UC II we saw anticipate UC regards be XX is naive which the the ratio in with Thank participant study. XX, XX we the study, biologic expose biologic With split

many this can a our like investigators resulted to until As and will plan. unblinded will their enrolling to IQVIA analyzed math anticipated. in we unlocked, study as our be sequestered entire of faster the clinical statistical the mind, participants, locked, I efforts XX. Arena database plan for specified both the and databases that in ahead the would analysis on blinded developed in and study than the keep team thank extraordinary With concurrently, with of have CRO timelines, will note data the the complete that UC that data do you you UC XX

XX UC of As we will previously, data during sets the read UC out contemporaneously and said XXXX. we XX quarter first

investigating study As cultivates disease. the in Crohn's etrasimod many of also Phase ongoing you we're in know, II/III

these this data data. size the pool data conducted from will with for enhance of order this this XX products. sample guided competing other additional trials a the provide previously year, to A label in that sub-study by believe we've end XX and We open to with set we commensurate of decision be participants the the will readout veracity increase trial While made a to of

Importantly, to study may program. this reduce overall data and for allow into the us X this registrational make timeline enhanced sub-study

collaboration Genome is into we Additionally, micro CULTIVATE substantial to entry today, heterogeneity. disease with biomarkers by identify a Crohn's marked Second announced in the program.

moving the So impact the response in target to the spreading the with multiple ongoing XX identify from associated participants Delta and to program. from our design potential clinical variants across potential be countries With to CULTIVATE Europe. of biomarkers enrollment, may COVID-XX XX the important of

for out read XXXX. We QX in are will projecting sub-study that the top of data A line

of participants treatment attention we're finally, in exploratory moderate small am adding extension of disease. we top open patient the milligram we a moderate our line through And dermatitis. completion XX areata, up. who Can a of in and our atopic X study expect study extension data programs, move now, the II aim us placebo data, population in participants. four dermatology point, the study data of study a ADVICE received be a data turning XX confidence to ADVICE the to milligrams week more put with into consistent improvement for began that will participants to that etrasimod a milligram opportunity announced present atopic key we of OLE XX% XXXX. cut who in With this through participant participation, completed looking alopecia from at population the Now to broadening XX etrasimod safety the study in of Today, study from a detecting excited date a the should participants dose the severe a the and X in our etrasimod with half in position the in XXXX, the include The please, X in X When to suffering very label amendment efficacy we the we week to greater believe protocol follow the across Phase in walking the etrasimod. with arm now III. followed etrasimod week you We washout ourselves study of of positive, open to investigating week patients OLE, investigating be even by ADVISE measures all to Phase and II to recent which Phase amendment, directly was opted At to clinical I signals of period the XX in label weeks to no period. controlled execute data with provide the the that taking Slide moment of the dermatitis. pleased second turn read promise this program were new I'll the see response

study. the across out point chart, week Slide the rates dashed XX I'd each to lines placebo bottom, the X. to on you'll move which Let's of ADVISE that at notice within represents like

We data. Also, taking these an the the the non-responder the by OLE imputation sake a line. we've view point rates at estimating we've the placebo of shown time approach XX taken have the Delta additional when extended conservative week as OLE applied for a of of conservative blue

OLE, EASI-XX Peak week XX. XX%. of NRS, efficacy clinical Further we week measure Pruritis the improvement As you at at and the look across of a the note consistent XX improvement vIGA, each you'll observed vIGA across

of XX% As When Pruritis improvement in for and III XX%. observed looking is of dermatitis. registrational endpoint studies vIGA EASI-XX, a Peak we reminder, atopic at the change FDA Phase an a

cross both of comparisons, note placebo are As data relative with initial range study with the deltas biologics is appropriate extrapolated of the the a week from caveats the approved XX you and period. in in day, as will the rates

imagine, can we As you very enthusiastic these about data. are

decision the milligram regards around OLE full discussions dose. the along Phase review to protocol we've With authorities XXXX. the in While X data of data the III with today, presented in timing, based commencing Phase still QX the our with we're set, design the anticipate on a world establish program we III Phase study anchor regulatory and of activities to to made III to the final

to Now highlight I'll Amit to our turn it upcoming catalysts. back Amit?

Doug. both data plan to months data. XX today, NDA ulcerative A followed at updates enhanced from UC for half QX and etrasimod sub-study our positive in XX submit in Thanks our X go back the expanded looking XX the we presented can XXXX, UC busy to exciting. be pending is and CULTIVATE and of colitis XX the In the we'll contemporaneously, next to QX. with please, by And see Slide you have 'XX, we If will

areata the We quality NDA as in regulatory. and CMC, continue to work several including indications. cardiovascular respective of clinical two from data support X population, half over second and and APDXXX the the 'XX, and in in will etrasimod areas work EoE in turn eosinophilic across Also esophagitis expanded including and their important patient data with such our of organization or alopecia temanogrel pharmacology, diligently readouts, ongoing milligrams and we

to Laurie through the over call Laurie? performance. the financial who will hand take I'll Now you QX

Thank Amit. you,

growth. staffed second of to back period for million, a Amit $XX.X quarter period basic XX, Operating to share to in to in support Q&A now to marketable in prior was second Turning compared totaled Basic the concluding year. the period at to the in the programs, $XX.X expenses for diluted as XXXX. same and the per financial the XXXX, diluted key cash second make who billion, in $XXX.X compared our the million $XX.X quarter for second same million, loss call the as loss million million, research period $X.X net loss turn to driven second compared advancement for $X.XX clinical the the $XX.X X the the quarter personnel and approximately million, $XX.X were the $XXX.X in in $X.XX and for per Slide XX, in period XXXX. and June $XX.X our burn we This expenses compared quarter of as same same increase measures, program prior XXXX. in primarily was March administrative I'll same cash some was XXXX. opening compared totaled Selling trial will quarter for increase development And in general and securities was million of compared to for session. expenses remarks million before well to an year. equivalents $X.X to by as of call net loss the billion cash, net share the And over Net

Phase we to We'll see have continue progress you In of portfolio. And Laurie. please. make line now QX - to entire we Slide we atopic I confidence performance, like we label at across of Thanks XX, data looking continuous And strong significant strong our we to providing direct in our can the make sight go a data operator, the a maintain that we as chance and continue presented Arena the clear a the III science course, readout. gives position. thank the future adapt for signal. let's and Overall make continue to cash we opportunity open hard environment to best program. of finally, the the entering ELEVATE extension work to dermatitis, approaches our On for continue and to our team of today and to entire we company. move to towards market, portfolio, us Phase our evaluate progress take where to Q&A. III that clinical competitive With the dedication this necessary, regulatory continue build of that

Young line sir. from you, is Instructions] [Operator Your Cantor of Alethia the Thank first question from Fitzgerald.

Your line open. is

question my and on Hey enrollment. for the congrats guys, with thanks progress taking

enrollment informing UC X of the wondered the of the X some been in things about kind there is of some maybe doing I would of study, the Just helpful. atopic study, learning the consideration get color And wanted COVID that? have be mg, the of kind one, decision you from two think such of during any guys and to into staffs just especially enrolling mg if as anything for you that me, you Thank areata proactively saw - alopecia in in as that being your there of light you. on kind color then completion move to the on just are

miss me please I let Doug, start Sure, jump If now. anything in.

data, know, blinded to time atopic X reflection II a milligram was not milligrams. the a study, derm X so chance at to did we're study in a of we you AA and thought the in take As get the milligram? the explore we look not a On to X Phase it's right this place so

I'll in the - of X population then as making final what important his study. prepared Phase patient And in study Importantly III. expanding remarks, we're of which Doug milligrams robust, to study and more is just to echo said X the concept the it potentially as that this us the by increasing a to the take study proof study a moving could and that directly from point,

overall doing So get timeline diminished gets that. the potentially by program

study. to that that's of really purpose the - So change

of you trial. terms etrasimod maintained in in In as enrollment touch very on we've colitis, the know, of degree ulcerative high a

entry the We possible to continue evaluate that to we day the have every integrity ensure every patient of day, to trial. strongest every

interruptions cetera, pre-planned statistical previously, of et our are the out for well discontinuation pointed I As study. below rates, and UC expectations other dosing,

in So in integrity. that as about we continue the terms to be well very positive of as where of data trial is terms heading, both timelines

Thank That's great. very you much.

you. Thank

Your from from next Neena question Garg is the Citibank. of Bitritto line

is open. line Your

XX a Dina How Will line is ELEVATE take a it ELEVATE you. last path XX? that for have the this will take UC patient the Neena. question for I data? weeks quick on from it analysis Hi, UC study. full just report Thank post eight visit about the long

timing analyzed UC XX. may data and to intended so trial be the are Yeah, together. do Doug earlier out, look The folks will pointed math as the as than

of expect period really that terms the to out time would on in not. the OLE in the whether is remember but study important analysis, enroll of it So patients the dependent also or last the normal end patient

patient So we'll study. as know exposure, and of end get between - get the how the of last about exactly timing out two we tight end we more towards the patient is the studies on

this We're Thanks teams and to your were So really we're of COVID on pleased UC XX about for stay middle tuned. a the execute at able the excited where in question. with that pandemic.

the from is of Jefferies. from question Howerton Chris next line Your

is line Your open.

excited UC for too. data taking questions Fantastic. and much the Thanks for super the so

you for take dose have me, etrasimod the is A, does curious the thinking? little And to on, is the the I'm how the kind also question becoming Thanks. design up study? work is, release maybe programs see the on of more a that question of I'm selection formulation you how is around for going extended around X into guess confused layer clinical me sub-study willing registrational? primarily your what a sub-study and going CULTIVATE what feeling I you're if is follow more for that is So of potentially what and status

sub-study Thanks for question. CULTIVATE design of with the A. The the Yeah. study starts

study does directly just registrational and X on milligrams. trials. patients, to X that's we're data open you have control. We've to able and that As expanding a It's a know to pool comparable of not get moved studies that placebo XX that's study By competitive products. a to label set done

study in the X same inform biomarker the dose a will the gives set, data would the sub-study at with should this we've top first and this a on to milligrams which placebo collaboration really robustness. we designed between it that, point, sub-study program our overall help in the a us A side, X power So finding to time. expectations, position as And X control size got and in line on be to was of X the The setting. trial. pivotal in readout And sub-study be

sub-study to contemplated case, and trials. So able dose moving this power large that finding be In a we'd being sub-study previously, to out sense. the III X then we've X, study makes if Phase two

Amit. Thanks does. That

progress continue the the the across formulation, extended on make Yeah. good And then second we question release. ER to

know, now the to broad curve. really at and we initial X so on looking try pinpoint and what to liquid formulations is initial you we're generate. formulation, exact we've looking of done milligrams to begin As And work that we're wanted mimic range curve X across some doing potential to

the right and multiple and So concentric formulation intellectual we really at formulation able between methods, new it's identify - and a And developing is that property. different concentric ongoing between circles work process. circle look an there's to iterative being

said property both the etrasimod, life into and indications. able to the extend of to expand role So and as extend the is before, intellectual expand being extended role release of new we've

that consistent bridge is so hope ongoing We said And with over programs time. work that what into we've and to dermatology the before.

cool. Thanks Okay, Amit. that's

you. Thank

line is Fye Your the Jessica Morgan. from of question next from JP

open. Your line is

Hey, what's comment study kind Thanks an close are originally for a taking guys, planned A, of enrollment first, progress a the given sub-study in can timeline you update? to a my little you of us extended afternoon. to on question. become bit good just give stands the patients? guess I XX for where How

Sure.

any comment So don't study's details on of enrollment. we

look path arrival Doug's begin program But change We that's are on spot evaluating be move we this objective our made we've so forward, that here. where potential set, we so a that to overall really regulatory on expect the with taking and competitive study. the to at the faster can forward,

Okay, so enroll just to it's earlier. call happening you wasn't that's that reason with Doug's XX this deciding able now arrival patients to and the you're make why a were

working on implications. were we regulatory through and No, working this earlier

As process in implications you through the isn't working fastest the know, world. regulatory

extremely So of important we were here judgment arrival his to expertise, making through already decision here. and with this is us really working confidence that we broad right prior gave Doug's Doug's were range the

and you basis? anything blinded part last data, comment see can from data sub-study basis, safety X on would far? be that so do pool Great safety an that - me, A a on And the pool on given ongoing just maybe of for one is milligram you

Sure.

And haven't external point. evaluated to seen parties fashion in to anything milligrams So a from go X safety at question X the by this decision make our is us we the that would and blinded SMBs.

thank Great, you.

Thanks Jessica.

the is Goldman Chris question Sachs. Shibutani of next from Your line from

line is Your open.

CULTIVATE patients' have into there enrollment modification patients the And on of features program? bit patient one to a to you to characteristics questions, exposure biologics the sense Two way much. any XX understand whether in understand taking a background study. that get account? very Could the UC from any is us help you of XX to us and thank helped you current the Great, the little

patients Yeah, so XX. Hey, no Yeah, additional in difference real Chris, the who be to thanks. will there's adding original XX from the or study

everyone As of severe that very defined study. the terms we what in patients There's Crohn's. studied. else want you guidelines to know, consistent working clear some moderate And with has it's in

Crohn's, as think as a Crohn's studies seen. with are Doug competitive subset products it's to the a pointed narrow out, subset. very consistent lot a is these narrow you challenge which know, has what designed of and other all heterogeneity this of have in evaluate I broadly, patients is,

So add Doug, that? Rob, anything to to

the Doug. inclusion just expanded size. Only yeah, This kept We've that, criteria the to is is. as say we've it sample

with be data be the on would So our of can bullish we experimentation. next set the But hope decisions. that we're have more of which phase basing veracity the in we terms human

follow the then advise on up and dermatitis. it be would Got atopic

a in You you work snapshot did a gave July. us of that

you'd get roughly that sometime this of I in more data doing the presentation fuller to when would should think a be and the anticipate previously, year, helpful said you've that we and be back still of that half insight.

the continue Yeah, a evaluate to we is that over label open so We'll the fulsome data time. data today presented relatively set.

this We an that data we're conference now. and present expect upcoming through medical to in working

we forum. that So as actually this a robust with elevated first in even But outcomes confidence are with line rates I think agents. XX you will additional get data just that other placebo presented the and in quite week the from in us we're gives seeing can see saw the here,

range again, consistent and of is think not We're that's this oral, substantial a front efficacy with the the having inhibitors the opportunity once us. incredibly in So excited able a of biologics. of of heading etrasimod a JAK liabilities the we day market deliver there's and profile to approved where in the about being being safety

milligrams And it part not be or AD the that clear X just forward is to predominant? that does the is milligrams, on go mean anchor X of word plan

Phase Yeah, That's correct. so the plan. it's not III part of

Great, thank you.

next Your SVB Schwartz the Leerink. is of from from Joseph question line

is line Your open.

there? in the Phase with more data? you that little just hypothesis null top ask them higher need plans CULTIVATE line have a dysbiotic Will I'll about patients findings Maybe doses? enrich enrollment Is your you responses etrasimod more much. very with patient along who do the CULTIVATE. new analyze to talk you are do What's III, worse responses about bit your in with that there? report to it uncover? Second what Would to collaboration Thanks you the And Genome or expect

and understand The Doug do the the then really start Sure. Joe, me really can to to let so and is hand it just beyond innate begin about off to talked we've T-lymphocytes. to talked out extensively we before junction of activity We've tight activity reason the this migration about system. pointed I'll impact role the etrasimod. immune Doug. about extent [ph]; on talked of We've heterogeneity that on etrasimod's protein

we're you really where more biomarkers to to so lend it? Doug color And excited see on these out. some come want

that say dysbiosis we to an just know is all that Yeah, important feature here.

I think there literature the is dysbiosis. of not a quantification lot on

and So we're see do terms not of to going going turn notion priori than is that's might to predispose enrich an the other population extremely studies point a that difficult lot program. is Crohn's a us Phase what rates of in And there having homogenise. with a stratify to work in or up exploratory to it then we'll done response the space cut if III in

success Phase better, we if it's to going respond chance predict I likelihood any to in significant to can to that biomarkers think find going III. of who's help could So the

going the dose top seems - two like were thought then and can you you first thanks. then III dose of of atopic high your It us And where you're And curve? thinking right? mgs considering higher. settling dose is how really ask on end two, you're Phase for about two like your is dose, you in derm? seem of around, It the Okay, some the selection that response selection about give and sounds at thoughts can like I does just that

us That'd can you great. give update your be just there. an So latest on if thoughts

Sure.

to handing can you me Phase relative Rob data to let competitive color why question we're to So of off that numbers the like how Rob on up presented anchor talk about on III set. and excited answer these we a competitively. shed the bit to to And it milligram. the today stacks program little X look by what

domains and data, Amit. are Thanks at you approved see what the with of what's be to. in that Good time When III. open the JAK a afternoon, that and to the happy at when everyone. we all trial you. inhibitors. you all response, drugs response data, would drugs currently success, join you able to label at endpoints all Phase in extension comparisons, just in with with look compare that But points, different Phase it's Pleasure see cross looked you caveats. to across that we're I'll the line Yeah. II, with actually look line those When is right, being all seen

response robust the and to Given weeks of signals time been based through for and We're and no see. XX that that continues the of improve the sufficient on this is responses observed we milligrams so that dose there's profile over confident TA particular safety is have X exposure. molecule the that

Thank you.

next Your Gerberry Jason line from of America. the from is question of Bank

line Your is open.

confirm size between the whether the and milligram the is patients, a X XX additional they split sub-study Can questions. for Hey, are Sean A. one, Jason. for the taking for evenly up up X you Maybe this Thanks the of first just quick follow on milligram? the enrollment the

continue Yeah, to X. Correct. randomize versus X we'll

- biomarkers of micro for a for are versus biomarker treatment of Got how it modality ulcerative that disease? talk micro Crohn's Maybe those not to what exploring is on you to about sets modality as and exploring a I'm so and like can can your IBD? as treatment And least microbiome far at - data curious on guess lot thoughts colitis. contrast you I if mainly microbiome as biomarker, a compare micro on data

Yeah, let that to Doug. me hand off

Thank for the question. Sorry. you

So minded. we're open

in there's treatments setting, or first Crohn's who Crohn's others look see disease we'll terms not also indicators individuals status actually disease the to baseline our foremost on of than dysbiosis and in have the of what see but impact improvement look the was at whether dysbiosis better of So symptomatology. their and to

add think, to SNP we're designing biomarkers to if we prudent patient in allow fiscally remainder in expeditious, population homogeneity will of Doug's be more which can relates the thing, more the one the point, with treatments the set microbiome; modulation. more against to us not combined it just we program. at the Yeah. I'd data far and create we're looking discussing that And the is larger as microbiome in just

file, of find respond And curious more How patients perhaps just to a likely trust you response with terms timeline you're design that market, better your for later decide if curious sort for question. to to trial they're you and plan in a population, of more about an a robust opportunity therapy? as you're smaller to data enriching stage because able set, are certain maybe what thinking that respond,

first Sure, this, want the into the you timelines on We if Doug, yeah. part take get to won't of but question. that

sword question. enrichment, need edged The validate Yeah, if need you to you for course two biomarkers. again, stratify, some thank of is with to would the you that then biomarker

So clinical that necessary always, our we're as must so. that, a here the for from drug do is the approach, still of of indication. trials to to the approve to hell drug, could try bent individuals efficient a idea an possible And have prefer goal and III most greater us help result our we'd benefiting Phase comers convince have number the get to that there's if and way take of enrich to us cost patients likelihood terms to in for regulators time who although do a not we'll that all on to one certainly for

the everything trails that doing we're expedite that in try setting. can the to of value medicinal to we So involved

also last appreciate score, up thanks for data EC of Got IGA it question trending the AD, the the me OLE on updates and one the and score. the with maybe just and from

interfere So you Is may is benefits that what driving any I'm thoughts increase longer time, to protocol the over have have is is might sort in of it of evolution sort it time. there if do with have any that history - those cohort whether your therapy? compliance placebo interpret natural part? in as data efficacy placebo be control to Or durational because no rate ability you just an that of curious the address AD the over

Yeah.

weeks, the from most finding that that patient the plateau looked made double plateau effect. from with had think a across no important we've blind and by of no striking weeks XX at that basis, there was I in see as ADVICE effect. point continue eight of we was portion to We increase patient year we the to earlier

important before So these of looking out put X etrasimod. us. that back at for Recall XX washed weeks on four patients all were we point milligrams was - for weeks an

perspective for you and size look at see So robust you look the at from at it's can in open weeks label XX XX that you can ways, very see, at to - cleaner etrasimod, response. effect a can study, again,

Awesome, thanks color. you. so for much the Thank

it. Thanks Appreciate to you.

question the next line Stringer from comes from Needham. of Joseph Your

line open. Your is

for taking Hi, our everyone. Thanks question.

remake Going trail, adding the dose the alopecia you're here. higher back to

That that can curious should little you. think severity - possible the arms. scores mg disease that? that X expanding on and are Thank Just additional if on we baseline how in subtype, mg patient expanded population here? a about that and based into sort stratified bit subtypes is Is you and expand of is SALT potentially X

treating Recall for for as the so X also that Yeah, patients, this we study, we're yeah, would areata we address we're weeks being resident [indiscernible] patients to talking to a follicle. The stratify idea hair is and alopecia XX T-lymphocytes and milligrams. subset. about give cytotoxic opposed broader at here X in more could so

able to to that an period. everything here has able to make XX have time be sufficient to impact do with treatment week having So being

So more yes, stuff will more and expanding patients. to opposed to here areata so at expanded we about milligrams broader us X subset decision based about allow that, looking on to we'll as to to make patients, X how informed move Phase think the get [indiscernible] to a we're a of alopecia III. And

to going score between XX from XX X even should placebo split the end per so SALT add, X have XX the we to of we're added at more, and just to of for XX And patients And or at or milligrams an Amit, up XX, milligrams day, approximately the with XX. a down arm. enrollment, to entry XX

Great, thanks our for taking question.

you. Thank

Thanks Joe.

Your next question from Suneja Guggenheim line from Yatin of Partners. comes the

open. Your line is

me. Hey, for question, my two guys thank just taking you for

the sample on size sub-study led just you data looking at That's increased there you first data? that without a or did the like analysis look First based or increase - any the take were CULTIVATE you on of question. - to at the

Yeah, the blinded data. to we're

based made we're driver. to that So blinded us a as sub-study That study. think the we the on allow We're, would a data. really this again, decision having was pivotal set about to data

unexposed how patient compare And would Okay. talk to be and XX, with to then biologic naive how XX? the looking mix that about the can patient you regard UC might the between

split. saw So we about a what is XX, This to split. is we which XX-XX announced XX-XX closer OASIS, trimming an

Okay, got be most will one of done it and that just together sets both to data sort confirm, you before will be analyzing these XX, XX. though UC likely even

to expand on want you that? do just Doug, Yeah,

be contemporaneously. Yeah, so analyzed they'll

the at we time. same will do So

be actually would the And at on walk each to to time with the for plan UC database the then the the run database studies do will NDA be the IC pooled going XX. where until time UC then analysis a approximate the the we're of of as analyses when ISS keep submission FDA. the same unlocked XX So to US needed for the subsequently and and to

helpful. Okay,

question, ramp update for in you maybe the year give the second final the for the the and XXXX? on maybe of expenses up could expenses one rest Just to on how an are or side, going half

you do Laurie to So want that? take

we Yeah, certainly, or in on increasing what And haven't enrollment But yet you burn $XXX a somewhat. our then first and can expect of obviously, cash all we have 'XX our studies, in I half cash 'XX. is guidance all patient have million of tell for did burn. in advancement given we would studies we of the 'XX so

thank Got much. it, you so

Yatin. Thanks

JonesTrading. the from from Agrawal comes Prakhar of question next line Your

open. is Hi, line Your

question. my IIIa taking for is Phase thanks question on ADERM first Hi, My trail.

suggests that high Bristol KOLs it's Phase if in you II? III Secondary the clarify there other minimize to Phase that to that to wanted any placebo our trial effect we Myers, long limited UC recently patients. know launched Thank implications commercialization about if there's any how a you. their but still and treatment refractory has to way SNP your that on UC thoughts [indiscernible] of pricing I thinking been to wondering strategy. to the are more should Just in in Symposia. the you're just saw expect you in conversations the on had changes commercial with ADVICE you compared go,

Sure.

- with take you start let's let please? So want question. Rob, the commercialization to do me that

Thanks. Amit. happy XX. I'm early. Yeah. It's approval May Their was to.

in looking within limited. market, been access weeks their market just we're of the they've relative at few data where pretty So is a

are most right payers limited agents. behind other for now So

stands XX,XXX higher think I per choices consideration another competitive year. a and therapies. bit is than It's out the other That's price market. much the in UC

too the is they payers is to the that generate that work study. other launch. prior and differences The the molecule between is try that demonstrate - there for work for the and did doing piece we're GLADIATOR one That's of to value to the key

So with my negotiating. they're would payers be now assumption right engaged and they're

is access group a which OLs. is their small hearing So why likely limited very from to you're of patients, that

first again? part you question the the I'm repeat of sorry. Can

on expect? Yeah, ADVICE any ADERM to III the other trial, changes that can compared trial design we Phase

the of Yeah, said we'll we moderate amount more a to is, Phase in atopic have so substantial program to II and study, we what moderate looking between be III closer split the contemporary of patients patients Phase severe a for derm XX-XX. in

we much the be moderate, recall, contemporary moderate for more thinking so to more at and in population. looking we're a you were If modest your split patients, of so at baseline, X%, severe

you. Thank

Thank you.

Hoang question next the from Your David line comes SMBC. from of

is line open. Your

my much thanks the Hey, and question. so for taking update

couple. the patience? in are - any relevant little a that, talk you updates So for is study just the about And I a GLADIATOR line bit towards Can timeline what's a there top there moderate of that status one? So data?

carry top that line expect to data work top that that approval, access. pointed the expect to to on as with Rob out data greater shortly drive line study set we So studies really for payers to and to approval payer with and have we enrolling after have is really GLADIATOR data

is down still ways and it's enrolling study now. So the

and of the to it different And you're few terms as X then we data atopic folks from of milligram the influences should ask may any ways, kind at possible derm that thanks. you arm or your but really I confident a just of X milligram Crohn's commented that X of and looking III, question in you milligram in dose, quickly, X sounds is see Okay, on milligram all like Phase kind here? know pretty have you alopecia more wanted thinking to areata. but I X protocol be to Is the open again it's type dose it and be then

Yeah.

seeing two seeing in very program, to week milligrams go are with reserve the effect to go of we're from XX. a safe leader. data its presented, the studies. is set what that X a was right milligrams Peak the rates So milligrams saw EASI-XX, look you we product But the increase, and score and we're XX the the that Phase Phase Pruritis the IGA III. in the of data, on separate continues out will week line market And at III to as X the back And

hear oral, lot imagine, X a that experts excellent doing about it staring field And coming time been and data. And to this advisors, of with where data at in very we're encouraging out. we is feel So with a once so can label milligrams. very the that about a validates as day how open milligram we from X good spent this you it's

week for us able delta from that continuing that to so effect to Phase a to we of very and plateau of question so about portion, lack feels from comfortable us pointed being saw out I acceleration previous the ADVICE III that And, out eight on and of XX. terms takes think As program. XX in really

my Okay, understood. Thanks so taking much questions. for

you. Thank

is Jason Your to from securities. JMP next up line Butler from question

Your line is open.

data Hi, at have you're for show first, taking on you Two any impact thanks not specifically that to that, trying And do etrasimod you the I CMC for ruled microbiome? ancillary impact microbiome? preclinical but rate a are looks don't questions. direct to the secondly, looking NDA And get me, submission? clinical have that Thanks. that work for have then studies, become readouts, UC work an there a or past the you limiting could out that on study direct

I'll take the part. to want you that, do Doug, take and Yeah. first part second the of

you part repeat again? first could Sorry, the

have Have you If you're the effects on ruled microbiome? treatment you direct impact looking a gut? the ruled at directly on a out the would just what out baseline don't in have the that you that indirect microbiome has be, impacts etrasimod

exploring be that our we'll not, studies Second one Genome. from in more of collaboration we just things we with the that's that with the intensely So that the announced but believe the models we human do preclinical

the past the part, in year clean form a over CMC been for all studies, necessary second nothing Okay, and as and sure rate limiting. as the are the We've quality there's NDA. toward then place making looking UC well systems working on well the

So getting there's beyond nothing rate the studies completed. limiting

questions. Okay, Thanks for taking the great.

question next Your is from line Markets. of from Capital MacKay Kennen RBC the

is open. line Your

the really with X for thanks Doug, completion, were that over data. or sort separately, that looking again, milligram just milligram wondering to me just and XX of dose there congrats squeezing forward what higher the in question or dose a dose? Or UC the converge driver there just decision X And versus Hey, Thanks there? great UC milligram that drivers about was forward thinking that maybe behind time disease Did big move Thank that? areata, you. any on is in to dictate another hear and ideologies in just of, recruitment X there. biology sort AD that alopecia that result following to about the of are the what that data?

the Thanks question. Thanks. for

populations the testing we UC. X in importantly, dose work that doing with feel very which and larger most milligram currently we're in we're in comfortable the yeah, So all the

those We forward have make never there's see and of the alopecia we as stated And indications. what results dosing terms for efficacy moving in X of those in say refractory right more both already decision terms we'll milligrams and feel in probe diseases like never. areata. to reason margins safety show you and Crohn's Amit And

proceed X we'll the way, diseases say like the to in have So And and we that that a then for it if consultation by with in indications think that. we is to agencies see about safe and fact probe lot in in select atopic dermatitis the that in more regulatory milligrams us ability effective.

back further questions no like at the time. Munshi. Amit would showing to I showing now to conference I'm this turn

being today. everybody, call the you, for on thank Great,

As significant the portfolio. And approaches portfolio a the programs for providing the you on science market and necessary we studies continue our think really us. to across changes overall adapter are important really about to the evaluate given programs. And week overall today. thanking anchoring presented and chance see, make to team make dedication the at X get signal the Arena continue like incredible excited to pandemic environments shorten we these the best of the designed out as timelines Overall, on we XX of of data really a call clinical as to schedule as a regulatory in derm, I'd lot to that's for being being atopic around of conclude Arena to these just we in by But for their hard external the the team the across ahead able again to specifically to and milligrams progress for well and work really maintaining strict all noise face and continue We're able competitive accelerate that's we studies data way execute ELEVATE integrity.

for continued conversations. the look to and on again, forward call, you thank So everyone jumping

today's concludes this conference. Thank wonderful you a gentlemen, participation. and day. for Ladies your Have

You disconnect. all may