Arena Pharmaceuticals (ARNA) 9 Nov 202020 Q3 Earnings call transcript

Good day, everyone, and welcome to Arena Pharmaceuticals Corporate Conference Call. This call is being recorded. I will now turn the call over to Pat Malloy, Vice President, Investor Relations and Corporate Communications at Arena. Please go ahead.

Good afternoon, everyone, and thank you for joining us today. as a this review third ADVISE afternoon, financial as had that press quarter trial. you results results issued line we announcing well hope chance Phase the to release XXXX from We our top Xb the both our

Officer; Chief Chris of Joining Executive our Cabell, Rob Officer. Medical and call Head our and and the Chief Development; Lisicki, our on Amit Munshi, Chief Stelzer, me President Financial Research and our Commercial are Chief Laurie Officer; Dr. Officer

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

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

turn call Now Amit? I’d the over Amit. to

findings hope baseline a atopic to participants safe effective an in this and AD. the I'd the results we he know from of research, derm etrasimod with X. This few from is with level trials for patient physicians patients in will market results line but to IGA moments, SXPX AD. be top had in different treatment in of before as a XX% advanced Pat, This demand and Xb summary trial. first of like Critically, provide our study is our modulator a everyone. trial does, of a trial announcing through the than atopic agent study having continued ADVISE and this or oral I for population recruited good of high extensive a this indication. and compelling trial our in press you've the Thanks, afternoon, chance conducted moderate release, to review a detail going dermatitis ADVISE population score greater therapies. The our of recently Chris the Phase

for plateau XX We set. in no the group X etrasimod’s which etrasimod in participants Importantly, observe in generally weeks and confirmed onset heart took dose and in X Adjusting group. in milligram no EASI-XX drug. other X by at advanced the across at and not recently this vIGA low X as Phase importantly, baseline nine placebo statistically endpoints. profile, will effects approved dose to trial treatment Across turned rapid of dermatitis. the the is the response in atopic four serious FDA parameters, the was X, study out for to dose Chris is withdrawal this vIGA, Week the approved in effect. but placebo. in Week dermatitis this approximately and design. which of recapture in diminishing more with events critical no the were us adverse – entire impacted Analysis what complete X to eight or between a significance from analysis at clinical participants rate showed the statistically Completer a including percentage Overall, study to the titration etrasimod the stages of The milligram action pleased X with latter the did pruritis compared endpoint cover significant data including in in first shows etrasimod was clinical indications post-hoc from on patient pruritis moderate And which upon on in and previous the quarter condition. the of At effect groups. seen serendipitous the this achieved weeks for to to of EASI-XX an with atopic effect allowed interruption, be milligram group interruption XX weeks etrasimod, unwarranted who of visualize consistent ADVISE The currently and participants population across therapies represents very the responder unintended, market. meet fact therapies of trials detail, Etrasimod EASI, know, XX you in in compared of change safety of statistical experienced the milligram trial Phase Participants the withdrawal who full effect baseline illustrated X XX% This significant therapeutic the study showed placebo an change exposure a improvement range primary was XX stringent as place primary criteria, XX% type Week compared endpoint EASI percent participants at of analysis full EASI upon received recently in milligram of resumption development. study of interruption, this

the set trial, we As to we out have three conduct ADVISE objectives.

an etrasimod that and aim population. safe was we dermatitis well in First, atopic to ensure tolerated

modulator this tested in mentioned, first the receptor I this is As SXPX indication.

provide could that we we finally, a that sought response be a etrasimod sought to signal the commercially dose inform eventually viable. profile program. whether move we would to an and And would have Phase a ensure into would determine decision that X efficacy Second, to

I'll ADVISE; past to our a number top who prepared always, were emboldens totality program global of registrational We key reviewing we've trial. then financial market are updates; agent data then These leaders be this data for were and highly program. our of provide In a ADVISE a leaders have the following spoken and demonstrated to by and of by as provide overview that an we thought Phase Rob, and XX an hold in Laurie to remarks, of some global our supportive line Phase and safety certain objectives as moving third session. into quarter met hours, the implications X Chris thought performance; these conviction Rob etrasimod and impressed oral efficacy a move expeditiously the Chris will will forward program. we Q&A will and X following the

So I'm to hand with that, going ahead go the over call and to Chris.

the The area moderate of proportion greater X greater participants this than in dose-finding EASI one XX, the to XX baseline for BSA screening to four-week four-week dermatitis scores discussed Thanks, by to enter than Amit, placebo participants to over EASI a to efficacy Xb Index was a or XX, from severe today proportion one Eczema and fashion assess then Severity one efficacy a participants top achieving XX-week with I'm greater EASI-XX Australia. was the line of Assessment the Week followed of to U.S., equal milligram etrasimod or through screened to from were or the four-week afternoon, baseline vIGA Today, a to Global of Investigator X XX, will safety and the completing or participants XX-week of a period trial, XX. etrasimod. body trial of Week baseline Patients validated achieving change safety only XXX of XX then greater Canada ADVISE, follows; IGA Phase data and involvement reduction X study equal the equal participants followed enrolled at the XX%. X, drug safety follow-up. and of pleased a to double-blind through and to Week we in XX, you All a follow-up. period. and equal the of male treatment X between to a follow-up pruritis. ages the open-label change baseline milligrams good A from extension four-week data criteria included safety percentage were or and etrasimod for patients four-week discontinued randomized X evaluating and milligrams the ADVISE between After etrasimod Week everyone. age; placebo-controlled, than take XX-week of of were across X this the Week completing the through in period and peak XX female as to Inclusion in percent The period, surface than and dermatitis. study and eligible atopic Area measures atopic by for final years trial include and In efficacy from

and to turn demographics now characteristics. baseline will We

baseline. As you moderate arms more receptor modulator can safety table, of from or a perspective, From the seen to with etrasimod similar severe be than participants at most classified were general. specific Interest in tolerated as having with treatment profile, this the of Events population overall score events see strong the well of safety etrasimod shown studies AESI for to SXP a X well-balanced. of was previous XX% an IGA with in was Special a mild. monitor We adverse Adverse class, that The

the shown see data here, can AESI were As you there ADVISE of the concern in trial. from no

there of cases macular non-disseminated one heart AESI group. participants shingles. well no two in were case the There edema. both group. placebo There in There was were And milligram case in related zoster herpes Specifically, X as the dyspnea one rates were were or with of no group conduction. as these the to or of etrasimod placebo cardiac

participant had X, further changes was secondary X or without were rate at a weeks of Overall, terms in X heart across a baseline single-digit insignificant. and dose, very any came in decrease any for as to and milligram symptoms. rate, In asymptomatic. X.X the favorable beats with reports groups a etrasimod AV first at X block heart rare look the the clinical ADVISE minute together placebo-corrected per Week was the observations. maximum the of cardiac change X profile the no the by was pressure dosing expected infections. the events, etrasimod on were milligram taking a classes, have One symptoms. of been in of to the thromboembolic were or milligram near X X These clinically transient been conjunctivitis, which heart safety immune from and beats modulator there three trial. These changes per or self-limited and through identical etrasimod etrasimod rate not heart In group. Type broader observed venous previous the group, there After group minute, and rate events of hours. impact AESI opportunistic and acne, changes blood from similar in have a The we associated no decrease participant serious X.X on XX, differences And trials went our mean

X, Week in X increase the count lymphocyte at reduction the ADVISE further In isn't unanticipated our well and with consistent study, XX.X% with an a disease gradual lymphocyte etrasimod. group reduction process count the this in XX. as to in etrasimod. on As milligram and analysis. studies maximum Between through affects effect etrasimod lymphocytes was yellow box, evaluating clinical expected four and there there that was the weeks peripheral eight, benefit. reduction This lymphocyte finding led previous is inflammatory unanticipated in which was this of It provides of to characterized, X target potentially noted weeks from was in a

As previously of expected is effect reduction on-target an lymphocyte etrasimod. mentioned,

lymphocyte interrupted per is decreased per the As if lymphocytes X, protocol, microliter. which Grade CTCAE than be to less Criteria study drug XXX could count

cluster starting study Week meeting lymphocyte around Grade of in CTCAE at drug number Criteria small X. a because of with only the study, discontinued participants a site X, single nine counts investigators During a

were of etrasimod’s participants action, As of etrasimod, receiving you the population. these X all X nine milligrams milligram and would mechanism total effective expect XX% of with representing consistent

indicate drug participants study Importantly, these stopping events personnel adverse levels for Notably, or These blinded actions taking that of discontinuation timing was protocol the reduction. were like did warranted have active by drug. investigators study lab no company which Arena values the without symptoms that evidenced not by other lymphocytes would to the study because drug. taken study the specify clinical were these patients lymphocyte awareness would and

was resumed count week As the in participants. counts of lymphocyte majority, a between this seen with the eight rapid weeks nine – lower and in between XX. between by lymphocyte group in decreases study Week four X red subsequent X and rebound In in was line, weeks drug there

and that was to this Study unnecessary discussed Phase participants important discontinuation was in receiving. plan etrasimod to and this of group will directly to from subsequent X clinical fact avoid unwarranted, of drug counter atopic that data We program clinical clearly learning benefit drug study it and dermatitis slides, incorporate the participants discontinuations. it benefit. in to led As be is or resumption stopping etrasimod apply the worsening to from were the in clear clinical of rebound a restarting resulted reviewing the

with not conservative of the Now reduction equal to versus the change compared significant. and from the endpoint baseline at endpoint than when a milligram of was X the of milligram this was of of greater endpoint XX% EASI. X more significant there four In population, previously week through which had of to the is defined though group, point where primary that in to a changes same the statistically endpoint seen achieving observation milligram effect. observation from at significant. was interruption that note, weeks important powered analysis treatment from EASI-XX XX.X% group, is regulatory placebo was the study clinic week with IGA milligram plateaued XX. which placebo X baseline, let's XX. in all trajectory X response baseline participants X of the from the in To XX% Week treatment overall In or this treatment not to analysis in visit group, success recovery at versus achieved not placebo of statistically change from we difference. over take rate in lymphocyte a success the placebo patient EASI-XX a – analyzed rate. an was criteria is the there group. look EASI IGA the proportion percent effect etrasimod FDA three a was was improvement effect through each XX beginning XX, achieving etrasimod From treatment standpoint, achieved is week change EASI the In participants as of time, increase mechanistic results. participants success due the the improved treatment understand the level X in not was of there of IGA In IGA, recovery of more to over to the the and efficacy impact XX.X% significant. between the withdrawal least shows primary moderate This improvement there's analysis six, the the with was group the of count through four. XX% different a four analyzed weeks EASI treatment to IGA the groups from similar with Even In relatively treatment and etrasimod of improvement efficacy EASI the Similarly, EASI time. and group reviewed, this Of XX.X% return it XX.X% we The re-initiation high group, at because four. or lymphocyte and XX.X% in IGA of the stringent, proportion baseline statistically weeks. lost, of did in eight at which X was participants for Week

In week time for of X there the these Week recovery of in eight, at treatment trajectory change from that assessments, significant X was milligram is effect both IGA the eight. difference with was the weeks For placebo after the and in XX point. group, four it notable group the between a milligram

week-XX. through will Phase take and likely time, a changes change the time, did the For looking X week to week fashion, significant interruptions, through we the XX EASI, variables of eight response improvement over at be impact four. and the In From treatment continued seen have participants. we over not weeks effect effect studies. we was completed percent the the experience between trials. over And understanding a in etrasimod with in placebo Notably planning, weeks the pruritis improvements in in from weeks difference was our plateau EASI-XX, analyzed time an Further exposure, X milligram this the which in was EASI. continued from significant similar of will early therapeutic would to eight there improvement see efficacy EASI on XX. and consideration we outcome we our trajectory XX in complete IGA of group in which key Based similar received XX six our that continued expect into at

separation For statistically excluding Week X those clear separation IGA group was Week to which time, the the at interruption. EASI was XX, also which continue achieving four is participants significant weeks there of significant. participants proportion We analyzed after show versus early over milligram EASI-XX percent and and the in and with dose of response change in placebo, XX, at

For IGA, a nearly two-fold was previously improvement presented, XX. Week there placebo, was you group treatment Of was the analysis was IGA, a at at IGA full than remember greater in note, that exposure, for in improvement a which when XX.X% improvement had in there that statistically versus analyzed XX. the significant. the And there three-fold full Week as

EASI-XX, compared to similar etrasimod at will fashion, improvement through XX over when there looking over pruritis treatment point the was changes Rob, to to was off from For now group statistically Rob two baseline. you. a placebo commercial the some to significant numeric provide context. I In it hand time, over a weeks eight.

afternoon to Thanks everyone. very and much, good Chris

You slide should a titled Cross-Trial be seeing Comparisons. is that

comments few see different the you a Phase results. X some on Just these may data of to that from share,

Just is XX been times demonstrates and Abrocitinib These heterogeneity select and studies. to part, be in both cross-trial as they at of clear, baseline but atopic studies It's design of study these it this patient well, dermatitis. the X may that the studies have both comparison in different protocols the studies also demographics different have in notable weeks. across were etrasimod Phase conducted indirect an

of other All drug were weeks studies of XX patients. the exposure for

we is largely that, of study clearly was baseline score, a It this particularly meaningful IGA me, etrasimod for the please. roughly XX% the of moderate is slide a demonstrates advance the in group the total this corticosteroids. next If topical to represent becomes addition included group moderate patients, Abrocitinib note as patients patient data, in In moderate-to-severe opportunity. U.S. can which of that that the because

at the XX competitive we end topical weeks here it's again, of a and we're one when of that other weeks included reminder, reflects So exposure. etrasimod a as endpoint choosing particular is corticosteroids. look in Phase dermatitis the And XX abrocitinib primary atopic X/X Abrocitinib endpoint. agents just as X point landscape, IGA exposure, have

limitations there by etrasimod comparisons, that's ADVISE. note attractive blue you etrasimod surrounded and statistically commercially we of the bars effect a our understanding for significant in that we've effect in demonstrated that of And size as in see always while is opinion, are that do delta can the appreciating So box, XX%. indirect highlighted,

in study for the studies. observed is While direct other with effect studied size in the that in etrasimod largely a demonstrates result Phase agents in line X

who Now Amit, a to key I'd hand the back and summary updates. to will like call provide program

Thanks, Rob.

etrasimod and have the dermatitis. moderate-to-severe a you ADVISE option with totality once-daily response in therapeutic etrasimod early overall competitive but trial, for in Phase treatment. the X And achieving achieved milligram compared stringent the the The milligram IGA recurrence, Completer pruritis advance statistical FDA Overall of onset demonstrated patients disease experienced unnecessary As full out of who oral, our multiple significance profile, further a of and rapid post And pruritis, upon with participants strong subset placebo. of etrasimod pointed potentially Analysis, previous responder points dosing X time seen four. In importantly, of data. and from dosing and the X improvements a week Safety of to very trials. baseline baseline by Chris in consistent group have in novel efficacy by safety received on treatment. profile week-XX, with effect to IGA to a atopic statistical change restatement rationale action, the should Phase EASI at And etrasimod represents from study exposure remains despite and EASI endpoint. with significance patients Participants program. therapeutic EASI-XX the X met as commensurate illustrated patients the primary at profile recaptured interruptions, interruptions criteria, and throughout

through be Despite Arena question-and-answer the the dataset address to other the questions during to continues we data clinical, about see, you happy COVID-XX on But like and we'll to get progress As there, you the walk updates strong before relative pandemic, can on key ADVISE to fronts, session. financial. I'd programs. make excited all operational, core and we're full

clinical Over quarter, milestones we our programs. development across have several the reached

etrasimod first UC with franchise. GI in we start Let's ELEVATE announced study, subject dose September, UC the our study. XX In

Phase by enrollment XX ulcerative remains of X within pivotal colitis of ELEVATE The by year, ELEVATE line the to period two UC program. ELEVATE in second trials complete expected same on completion continues XXXX of of the the expect The with timeframe. shortly XX and track to readout strong the data within and UC this make we study the the end XX thereafter. the progress, data week treatment end top

resurgence continue XX enrollment you UC to impact the As on COVID-XX expect, we UC for monitor of might the study XX. both and

or the studies our plan contemporary ELEVATE mix a have to as our And in UC to in of of program, the both protocol. such, patient population. has not our study limit chose For been pre-specify we patients

treated We the closely the previously with and currently and we XX% patients therapies. to distribution continue be XX% approximately to advanced patient expect monitor distribution naive of

UC letting continues score GLADIATOR is to trial six, screen patterns, advance. the addresses by treatment for The learning as conventional may to to the therapies, are with those controlled risk in might score greater that designed sub-optimally defined failed Mayo profile endoscopic the ELEVATE program. of one, be September, need a etrasimod equal etrasimod or have inhibitors. GLADIATOR as four modified evaluate patient broad resistant an mix study but Etrasimod dermatology announced failed have who about patient less benefit UC. or patients to biologics in unmet by current who are we franchise eventually ELEVATE patients or severe as more JAK but patients well the moderate contemporary UC be GLADIATOR UC In in used population new to Importantly, marketplace. to a where we evolve enroll

EVALUATE, In first X ADVISE announced September, in etrasimod the in addition alopecia our of the we progress areata. trial to Phase patient dose trial, the in

milligrams all will learned X of from assess ADVISE areata. trial of subject once etrasimod safety have for alopecia we not any efficacy XX to these with that the will seen X a XX. daily on similar the the trials, of multi-center In reminder, in based lessons or we to To-date, monitor was severe issues this Phase and discontinuations continue randomized placebo controlled in moderate ELEVATE a trial. type As

Moving on to olorinab.

our cannabinoid of of As receptor oral Type announced for and visceral highly-selective conditions. a the investigational in have agonist for the we X both broad full in IBS-D. the people In trial, is abdominal have that IBS-C a of full we GI completed CAPTIVATE olorinab reminder, potential and who enrollment olorinab range October, pain evaluating three doses pain

We cardiac in read XXXX. progress, in our APDXXX, CAPTIVATE expect top-line also the βX Phase was to continues planning acute process. reached treatment in our I'm data in of and completion announce to safety for APDXXX out X Phase of well-tolerated and generally for selective mid-QX, to franchise development safe X heart pleased myotrope study. cardiovascular antagonist failure that we're a

unlock value October, of wish announced luck asset year. end the at take these endeavor. finally, the clinical neurology successful unveiling I'd second congratulate be of leading him this of Kevin we the opportunity programs. expect Longboard important which the before will of Lind also cardiovascular Pharmaceuticals, in and like we this to best to stage end will important with the inception franchise our And the of a the We of spin-off

on streams Importantly, programs. value Arena’s assets, well ownership future Arena participate royalty the the as in in specific of the shareholders these as entity, will

results I'll Laurie? the our the Laurie that, to call review financial quarter. with to for pass So

for compared the for $XX.X to net period for XXXX. Net same basic prior as support million results, securities I in and period clinical per $X.X XXXX, and third and $XX.X afternoon, $XX,XXX to good Research XXXX. to as XXXX Amit. third earlier the operating The our diluted from was share financial development provide primarily million per in $X.XX of was brief compared of general quarter continued totaled in $X.XX compared to for compared $X.X the today September And loss third the in our the to spend. growth. same diluted focusing the increase quarter XX-Q. XXXX. by our third quarter period loss optimizing refer $XX net in to clinical expenses billion, Thank of earnings our and to third the while Revenues increase expenses This for same million year. for our same in will program $XX.X everyone. were loss administrative loss and $XX.X were programs net the Basic we on the review staffed trial XX, XXXX. release June million to driven XX, but please expenses And trial press at through and of milestones, in an quarter equivalents billion for quarter well XXXX. and quarter for $X.X balance enhanced advancement regarding quarter reducing results, a Arena compared period marketable and as our personnel compared was as in the cash approximately million details more third the you, of million cash, achieve development to million efficiencies clinical expenses share totaled our third $XX.X operational of

for is year guidance operating to to million. expected full result, a concludes the previous $XXX be our burn million range As $XXX remarks. down $XXX to our cash guidance million is of prepared $XXX for from million, That XXXX which our

up the take brief to for open open question-and-answer now up we’ll and Operator, the question. first I’d our call lines please like a So session.

Jason with Bank America. line Instructions] [Operator the question of from of comes Our first Sure. Gerberry

now is open. Your line

my for Hi. taking Thank you questions.

in want dose UC guess, trials. UC modification I I the the would – commentary I question my follow-up the the So risk just with first to of around guess, X Phase not seeing,

there like ADVISE. given sounded Given it – visibility the lot of blinded wasn’t a nature of

Phase trial then you what wouldn’t curious, the derm about think how Phase are dose how commencing for modification confidence curious Phase time? this you be risk sort guys you X during just a about gives wait in in to atopic you about Would that X think Would start a UC And you situation X setting? thinking mitigating Just the So Thanks. trials? of a study risk stabilize? guys there X of Phase COVID-XX surge? a

Jason. Yes,

any study going X looking to we’ve Phase to due back X our to and So just Grade had not discontinuations forward the lymphopenia OASIS, going discontinue back – into.

And lot think and so the we about it. know a they how community gastroenterology about

there’s that real more that They’re I require is are – education. lesson think cautious. subset the just a of dermatologists more here

this X. Phase of And have this be to – we thing specific more as to so we dermatology for much that to we’re mindful think is going a go

in more let ask color. lend So Chris me to

say, No, we I to discontinuations going think lymphopenia. haven’t in relative trial you’ve the ELEVATE got was seen it. to just any I

And we’ve Again, unblinded in as so obviously to here we the trials looking us. – study that we’ve kind lymphocyte blinded because is of count, to that at been we’re was these that issue go.

so wait show record. until to things And these have data electronic capture in the up we

And so moving. how in confident program are UC things the we are

Yes.

We’ve back really it extensive and again, different these So of agents and they lot community. how comes specific conservatism to gastroenterology general. the a types got the view in Jason, experience specialty, in more safety

fence. that any seen side the haven’t concerns We of from

will global the agencies. a starting studies, to it’s anyway a to be external with work want experts. derm, will the take while and naturally conversation with us In study various going have regulatory we atopic terms to a of design It

setting on a if pandemic. the start along look at proceed we’ll can, are a see in external the prudent that path landscape most and we take we depending where study we’ll to then expeditious the and on So, at it’s

will get decision initiating close trial. make we then to the our think that and continue preparation, we So as I we’ll

externally. uncertainty of lot a Just

to to a Yes, the mitigate having this how setting? it thing? could if this trial. site try ask I the be avoid Phase all in the investigators follow-up, – sort to selection you you X might about Is imagine avoid to I try do kind do dose modify the of Phase they of have discretion that and to cautious allow physician you have more X in

sort how you of Just that? curious navigate

Sure.

as setting, more novel, I entered think a will to thing subset of into the these novel we looked you who is go you’re finite if a engage in they’ve action clinical sites of at will when areas as MOAs access investigators entering X, drugs and experienced Phase a have most broader dermatology mechanism to and sure. there first with trial for is,

mechanism us on that go The the the really to side Phase and paying be on we’ll other, we the action, X. attention on education particular into of as burden is

other dermatologic relative lymphopenia continues that consistent this in the safety, that be then efficacy and of focusing plays safety the I while how in around to really critical. the piece that’s on being also have comment, just continuing to into educate dermatologists safe. profile we all very Going And trial, and our across the experiences, just patients think to established, to

and even thing could X and with even see of not the with we’re infections And seeing Grade X, interesting that’s Yes. is, Grade opportunistic – here one with really serious the you that we though other the as reducing X. maintaining oral education of able even move lymphocytes being T to part will we’re agents, surveillance, immuno and we’re communicate an just that Phase to be important

Thank it. Got you.

thanks, Yes, Jason.

And our from Young question Cantor. comes next line with the of Alethia

open. now is line Your

versus this the the their Hey, those measurement is little to kind position? the lowering you I and answer, think additional for in lymphocytes, guys. other? about of and my a talk vIGA measure taking and might COVID of Maybe kind with derms, environment of in achieve is there I thanks able those? but And differentials endpoints being of in light two EASI-XX, endpoint know details I to wonder, think then Thanks or for kind the can me. about, the being how in the One, one sensitivity just any questions for Thanks. a just the default just of And versus all bit the just today.

one let of don’t that tell the It’s whether take first sensitivity, COVID just sight. have on I it one, difficult off hand Yes, second mean, COVID we not to Chris. was to I’ll sensitivity the line or endpoints the me and

patients it a had that Chris of in single cluster As of a mentioned, was the clinical site effect here. most

education So, here we’ll these the spend job clinical have side with And sites. to of sites the sure there sensitivity the front-end making clinical the is did more on we’re that definitely getting we experienced just additional the more on dermatologists. time and

versus So, you Chris to want vIGA take EASI?

Sure.

study. high couple tends and one but EASI on was of It’s kind is on of one placebo key entirely rate surprising this there a has in and in particular on you when rate observation moderate AD, particular, a moderate other the MOA. that, in think fairly EASI had of to population placebo the be is in the been And higher higher Phase EASI, placebo that high side, a the the we observations X levels, that I a rate in that is studies not not here IGA. novel

things stringent not FDA importantly, more IGA not of high surprising, also the conservative, it’s on two on more again, going regulatory is that’s but and side. endpoint. kind the there, So And IGA

effect, sample the design going driving And be going is so to to and treatment it which our calculations. is size be IGA

And about side. the what IGA on good feel so happened

answer we Alethia, did questions? all your

Yes, thank that was helpful, you. very

thank Really Great, it. you. appreciate

the with And of our Credit Auster line comes from question Martin next Suisse.

now open. line is Your

on for how other in then curious hit questions. and how there atopic in had contextualize who those to Thanks interruptions; analysis? endpoints, patients onset start Yes. Was you handling can put you for the were forward Marty. here. fast patients, Hi, primary at context, taking Thomas of was Thanks. of meaningful carry you these derm of kind Maybe some there? handled be last that or kind the I two statistical relative It’s you this other Can X. some on guess agents first, of dosing clarify AD, can And I’m key the that Week everyone. and action, of clinically? might in saying, kind if full observation XX% that

Sure.

the part Chris for the that, have set. full is Let first me take which the analysis of statistical

the nine set, So handled XX% were participants any than on the any trial. subject those other or full differently in analysis not

methodologies was trial, it or analysis not. applied So had imputation whether across that different we the we

And so difference. handled they weren’t any

data, Week that not – not. on only the say, So or XX doses subject that the missed whether and missing, was any didn’t that dependent they we’re

the same exactly handled are they population. So as of rest the the

And your of second of action. on the fast part onset the Thomas, question,

safety about know real that, marketplace think provide the and fast we important action, going I on profile, what with here to Rob? combined we competitively. I’ll of Lisicki to commentary key be think onset some and is ask Rob are the the things how those

a Certainly physicians and Thanks, quickly hi, chronic work Yes. illness. it for these drugs is want as that but patients, possible as Amit, Marty.

So of agent long-term important. an is profile the really

those efficacy, patients. agent use any two the but long-term exposure is the be are the may second the potentially going of recurrent then an AD. And and to to one in components relative have challenging others that will is monitoring JAKs So of for safety therapy provide. is likely be disadvantages agent. Injection

of really So has etrasimod of think profile. efficacy, the attributes, three and think of use, a we ease totality attractive safety you those when

to two of your by see question, these you start Specifically studies most to weeks. separate

we two probably So, key studies, you In significance endpoint do it have. an a endpoints. And in to as soon for statistical as see some that’s situation, think the some of that days. they valuable acute measure

little in chronic for a a administration I patients. think bit so or situation chronic less

So does that answer your question?

you. that’s Yes, helpful. Yes, thank

thanks, Thomas. Yes,

line And the Capital. next Kennen from question comes MacKay RBC our of with

is now Your line open.

of Hi, stay the entirety therapy is there safety did thanks of or efficacy X for given sort that from question. across derive if group, on anything milligram of the the taking the terms we etrasimod in patients Wondering profile these study. can

what Just team the stands efficacy about again, out Thanks. group, the you thinking to that or and safety about profile? most

Yes.

in two for than and but two believe terms the all makes the who does we the of nice stage of of about interesting across bit milligram, metrics. the see evaluation. two It’s as received next Analysis it do X and full across of at milligrams we better really two curves one. question the interrupted Encouragingly what’s dose whether, especially most that those better safe a Completer X our we little in look one that was think looks I on sufficiently beg three us the response patients threshold two pushed we and strange, look So, the is than patients a is

milligram for there we Crohn’s time, two again, of So be for both X trials, potentially these be on chronic interesting in about and X allows milligram, so setting The terms a final future little we’d that bit may with have and just patients even XX-week data terms profile, we those point more in and by exploring in etrasimod go a three, milligram, CR year XX-week, is, of to role the I year one you we’ll some from while one the and as can the which we’ll thinking be where at have in point know, in therapy, too. conduction X looking this up looks informed bring this version.

a gives longer about lots time. us of for options period dose think So of to optimizing over patients these

it. Got you. Thank

Kennen. Thanks, Yes.

Fye comes our of Jessica And JPMorgan. with next question line from the

open. now is line Your

include guys. admittedly in more And question. Thanks more my if about placebo, you’re patients so, try to X. curious, this small to foreclosed Phase obviously? it the of subgroup talk Hey, taking is going I’m trial relative IGA the for severe patients how in if to to did possible

IGA of and all competitive Phase effect, I’ll more understanding program, groups with or at X X. more response severe scores and than all look in And first you programs IGA type the patient, for a Chris moderate The looking little the is to answer X this part it’s we the the patients the So, let see IGA more in take about been magnitude the that. One encouraged in are actually substantial. and of a stratification if the patients, it’s little second thing IGA quite and better across one. bit for we’ll patient severe be

the patient more the is being So to demonstrate important opportunity able to and modern substantial, that patient is numerical population us. change

terms know to in severe really of population for, that is in we’ll patients. market the of more severe later inhibitors disease balance our JAK moderate reserved opportunity. the We of serious more for dupi So predominantly used the research know have We available with will that severity or more patients. disease. need in from They really duration that the the that market or be

So we’ll have things balance out. to those two

of want X? talk the IGA about subset to You

in be somewhat groups. that out those of those relatively terms IGA had limited analysis – a The top yet. small X in the sensitivity say bit. because we’re just certainly little data number conclusiveness patients there to populations patient of lot at various have a be line of the to not subsets to Well, mean, we we analysis that and some in will doing tease I of going and a just looking

you. Thank Okay.

Thanks, Jess. Appreciate it.

comes question next from line with Securities. JMP of Jason our the And Butler

Your now open. line is

Thanks Great. questions. the taking for

you think the in any other and you mentioned the those that? dose think milligram about is sites Why And Dip] And X from I placebo from for to at in just placebo one, before data you’ve included a managing in sites, do data for for Analysis? the placebo effects X example, then rate, notable patients First the placebo the [Audio where clarify, just have the findings there on arm? sites how the higher placebo Phase effect the Phase And Completer interruptions, trials. was those other were study? for Thanks. X

think I there, it got I questions right. three if So,

why in for of they placebo are X higher where a through rates you the thinking trial, and studies mechanism. Phase So, terms in have novel

So answer. we the really don’t know

that different would disease, that efficacy you general, the than when in conjecture you the in action in dermatitis and just studies, in So have types an novel have the of here, participate atopic of in particular of a fundamentally a signal. investors that a studies be maybe once larger the mechanism already investigators types participate

may aren’t be to perspective perform detailed a more sites in participate measurements, experienced not consistently detailed able kind so these of measurement. that is may trials much early an EASI of some clinical from as those and be intensive more and that And it experience

rates, EASI in studies a in Phase And that related are mechanism, the X where higher. of particularly so have trials, novel lots placebo you we see to

on we concerned X going really not and focusing to Phase going endpoint, to main be as again that, about be in are because IGA We’re critical our the trial. that’s

standpoint work relative to trial a distribution We different from X experience do be that. an think So, have we’ll Phase that to Phase X. in through site will

how those just placebo rest if was like there where site, Your one couple we concern was Again, analyzed at discontinuation, of the on else And of sites. particularly every other sites, nothing right. them there that scattered interruptions a there drug cluster was the to data was There analyze I got is the a and we others. do question was across where of have had that did. last study at we with to

not other is that in And from concern. else there data analysis. did the to We the patients led so exclude nothing us sites those from

for taking great. Thanks my Okay, questions.

Jason. Thanks,

Suneja Yatin And the our from next Guggenheim. line question with comes of

line Your open. now is

my question. you Thank guys. Hey, taking for

saw With think two the have XX% lymphocyte healthy XX%, So a the study. in a what you that follow-up. the about from difference me. you count Any for OASIS study in was here? it I reason volunteer I us and to done? And reduction, remind regard you’ve Can then,

like say would it not I much looks No, really OASIS, just different.

you that’s Okay. the have endpoints because maybe significant the gives point will the you to you’re And XX? on capture ask Completer, point, – just Can be are a endpoints, to a is Why that, think confidence better? you be no additional efficacy And across case? data is then the sort if that assets and on I’m time at that then, with focusing certain. What regard Week you all separation to it fixed conviction continued it data that X, the is is seem look the to doesn’t saying Phase XX-week separation. I There going but I is or that a XX-week is the there of some like there study. us gets data at reason been

a with talk then and specifics. that about sort response, answer Chris broader I’ll Yes. of can

difficult to from seen time. in challenges size this gets Phase continue in continued see in sample interpret, to with in X As patients, we’ve will to the response, the the improve be effective work over the etrasimod see improvement OASIS – but continue because And continued in we open open-label Completer one patients and we of label. the do response response smaller, it's

is would otherwise population. be think in to Chris? patient it So this no reason there

Yes, though there inadequate we XX% obviously, all show the that's I we exposure. set, in patient you the right, IGA in if population continues Amit. from it's separation had that of placebo looking response the didn't, didn't exactly and brief graphs, even IGA And you at the go back full of analysis therapeutic to be group, graphs, think of presentation, particularly a review but

benefit know our therapeutic so to continues in experience with there etrasimod, OASIS And we particular, be from that from derived time. over

in from would related of have at but the here IGA, we it Week curves, be EASI that to to things the like data we’ll and XX. our modeling at likely you the continued but that see higher some so separation do we XX, would believe that see effect experience this to also that look significantly And is Week particularly treatment overall and previous

able data cleaned it's help we in there is which piece for that this at be other have is account to label, – in X. yet, at going label happens of continued The we aren't be we exposure in data discuss so the trial not to get and plan will our to have will us come to into will look into we're sense with that will etrasimod because out we'll obviously, extension data be open plan. locked, to as what planning, going that open to But a our exposure, planning that data Phase take long-term significant liberty caveat

anything Rob, to side in XX add XX? of from the commercial terms versus

things. two Yes,

look the improving the be First, curve in point, the if you the what separation you between Chris's two of placebo. see to at to slope appears

at Secondly, and programs when across look studies. are I think probably XX-week the is, they more you Phase studies, importantly X

a readouts other other in comparison or for provide So in that we development. agents are fairer to market either

much. you very Thank Got it.

Yatin. thanks, Yes, it. Appreciate

And line our next Joel Beatty comes with from question the of Citi.

Your line open. is now

the taking for thanks questions. Hi,

this between potential etrasimod to somewhat to for outlook the might more that's is, patients in of a is, expanding data indications? placebo? what's study one for percentage a have something is of with show and would today, The have hand X, that larger question then dermatitis the second larger gap first they enrolling the And treatment Phase severe other

your be a mix to think looking modeling us of the patients. other I indications. we'll so, out that early and it's on question, absolutely, Yes, at about looking at think dermatitis first for Joel, answer is that And little

of think that data, digest year, study, these overlap start to conditions. COVID our be we thinking about of to with plan other this, begin EoE looking more those areas to our become here. and data Chris this dependent. more X open to the And data. we I then At Phase label over time, see readout which start fully as will as we'll robust mentioned, EoE toward hope our programs we continue need But to to we conditions, not derm. of tend I fairly near-term work to But UC jump bidirectionality know going tend fresh do the it. and we mentioned think We get derm we've to to from bidirectionality to we in the priority. have as and is atopic how to that's We X be Phase approach that's dermatitis-to-dermatitis, other try ready, follow sort the got We’ve will atopic data our EoE biology. to

thank Great, you.

Thank you, Joel.

And from our next of line question comes Schwartz SVB Joseph the with Leerink.

line is Your open. now

about reasons the ADVISE for much. very for if confident you enrolled Phase whether being in could you're was thanks you that that moderate can AD? I control patients relatively X in Hi, and talk the wondering

sick who of are Yes. tend actions, have are less patients one There the number happens Joe, things patients. new moderate Joe, relatively in in time going that for to that limited general. mechanisms the those sites more of are of that with first open more is to the is comfort site and

Chris's sites side. that a effectively address we'll for evidence clinical severe now moderate sites, database, So more to that practices. the of part shown broader more we're we've to EASI larger got study, the strong we've sites, is that experienced on of able of patients safety think and set experienced we both how have Again be a point, also

is signal with we the had step the So conversations we yet our view that of warrants with to. moving was we forward right didn't experts and and point clearly from provocative clinical spoke consistent in the direction, the

just us much able encouraged to will the more on the think be and which out get And this experienced being MOA, all So that we a safety incredibly profile, sites to of with. a investigators. matter and of give access folks range broader will educate we're

supported studies. ask I that, quick X X if versus comment opinion the the in just Phase one is the what Yeah, to can by and you see Phase

X patients X dose study four. across some Phase four. cases – high for see IGA in If their also lower but I in uPA, a of their of you XX% you were see look arm for lot AD, example studies Phase of rates as mentioned this at in heterogeneity, the you

it's not etrasimod, than the higher. higher again we in significantly saw it's So number but

That's interesting.

analyze be do Okay. determine the to information have work take you best you make dose that then that to what doses to can doing And will you forward? or decision? What

Sure.

clinical the look here. is the It me start But in of we'll the is UC further. then study. have one we and milligram had leukocyte at comment then that's recovery decline. to mirrors that know the active weeks, the response nine the both know then of that, lymphocytes, Let really Chris that pharmacodynamics We the active thing four resumption patients And interruption, again corresponding, of who the right. was to the here the actually X with watch interesting drop and

a really look counts look nice you with leukocyte very quite identical. shapes marker really have So, PD – the really dropping, the

same study. that So that phenomenon that exact X gives is We reason phenomenon same active. here. us seeing understand to exact We're milligrams in saw UC the

push dose to discuss, I of whether that's milligrams, thinking we'll mentioned, as X So something we're that in it. have we up about

would whether think We with patients. broad bit, look have this little we something we at index you Crohn's. week, dose are be X there therapeutic milligram, in we for it. have in see began might these general, compound, our the about thinking push healthier a this to Then a have to example And worthwhile

So we'll keep guys updated. you

of our lot our We is sweet have two is think do work spot. on that, definitely – we a to but

relatively data study, Phase have it's intensive small Yes, that, because the into a X to only is look to pharmacokinetic add we do thing that, at.

little relative through look data data dosing. it's to biomarkers we PK of time, to think but So that to relative going a take that will to relative bit and that to at totality clinical we'll other it's lymphocytes, of efficacy, use

I could that XXXX? actually, then think might into do XX is housekeeping ELEVATE ask you question, And and if it a how XX data flip early UC Okay. just

early question to flip Is I'm was? Joe? XXXX, that your sorry, what would

the late it in Yes, to should I be collection we just release if data you the it know be noted XXXX in your reported would well? itself, seems XXXX, but in like that expect didn't data press as if

year. by is treatment it of Then the will you the of to of in haven't by the weeks completed it the the but end that enrollment XX. we dependent, go next we into end We think Yes, that year. some think end COVID UC takes be of do be us of XX will year,

data shortly tell have we'll to right really So It's hard now. thereafter.

in the things had these study, As and pandemic example, Europe, bolus a you U.S., when get for screening, here patients wave second in, of all the pandemic, of patients, you of close know that to and begin the the impacted. the end of the you in speed those ongoing

that two. it's push end before So enrollment carefully. be. we're over when which if we'll read to the watch look to have December, can’t that you, tell Right data next weeks, take watching we or that's into just will now XX the the then and XXXX, early complete And November it of for month and or the year, would that I going

Thanks sense. for the color. Makes

Yes. Joe. Thank it. you, Appreciate

line And our next Wells question Birchenough comes of Jim from the with Fargo.

is now Your line open.

Hey guys, thanks details. for taking the question and for all the

the What the that was I didn't for that benchmark the me. JAK how placebo? the that versus inhibitors? might missed guess the moderate XX% population against one, couple for I do dose like the at X is more discontinue, discontinue. in improvement you EASI-XX part but milligram didn't Just it, And second things guess patients I have their a

me Yes, so slide just … pull let up [indiscernible] that and here, I correct,

that interruption. comment. one not Just they there It's dose discontinued, was

Yes.

right that then and clarification, go make to Just Amit. ahead,

of a want put So EASI-XX, competitive some delta you context commercial the we into XX to which saw that Rob, about products?

Yes.

a of that baricitinib is on delta. the in the EASI-XX So be would that range delta,

included baricitinib, a So it's tough topical corticosteroids. study because little with their bit

that that So in if same you range. we’re roughly look didn't, at dose

a it's dupilumab. slightly If the on delta. IL-XX, it's JAK's, much of pretty you little south of the – top and of lebrikizumab, look bit range low-dose It's at IGA in score, the

the the baricitinib. read of in So strong a is was through really the and EASI-XX IGA neighborhood delta

on to the just then on any took remember have between and expect sense you effects, THXX? you different you of if you collect but at some data how population can't And the THX do do how in would either or and if cytokine THX, still impacted cytokines? I patient THX, THX, the the THXX, this could And blood, pharmacodynamic biopsies you look responses,

is of have can you. do that type share time. top a we line with almost we Again It will data, over lot analyze this Yes, a data. before real of do be we'll that that while and But time.

So as as you we will look definitely We're take that. a curious are.

question. one maybe Just final just

a Just contextualize AV deal, a from X single isn't ponesimod, but that maybe block that for Grade I recognize proper to patient seen a big in just context. we've with what just

Yes, so, that? want to you take do Chris,

Yes.

relative So any to SXP low observe to issues very ozanimod. and of cardiac modulators the in ponesimod class we rates continue other

very low issues. and of X,XXX have patient We nearly seen exposures cardiac have conduction a rates

volunteers. healthy it's fact, in see In epidemiologic of you lower studies what than actually

the good very cardiac profile. safety about feels So

substantially ozanimod that Phase its remotely again, And severe. of multiple their studies. cases titration, Ozanimod after anything adjusted within haven't we about of in titration. different, talking placebo had eight, sinoatrial back are remember, that evidence range adjusted also then thinking weeks block recall rate that we no again X going are And no – to placebo any have day seen double we're we six digit-heart

taking Great. questions. Thanks the for

you. Thank

our line & comes Company. Alan with Needham of the question And from next Carr

line Your now open. is

Alan. Thanks questions. is Hi, on for this our taking for Joey

expansion? Thanks. quick many mg entered a the disclose to one, Just can you patients open make X label how

the data haven't that. not I'm cleaned been We this point. has disclosed at sure

the weeks the on see as share soon of as as safety. as Again this you. be data efficacy on have we XX of with sharing first to you. that line So open it But label, digest and top we'll was we the the it, soon XX stated designed with forward we’ll can weeks and we look

Great, thanks.

you, Thank Joe.

And comes with Patrick Wainwright. from the H.C. line last question of Trucchio our

now Your line open. is

afternoon. Good Thanks.

Just a few follow-ups for me.

how possibility approval? perspective Just ongoing post or is, how about either potential some the think derms, label its monitoring the inhibitors? regulatory there increased of that an one of the the by the possibility interruption, compared JAK AD if in novel X to a is could should clinical then lymphocytes like of quick and from these the for etrasimod, And program dose can level first into we Phase potential the other And how compounds upon secondly, demonstrating ADVISE in factor rebound data that approved.

Yes.

about ongoing you of bit Rob, can – profiles, context, competitive to all label of monitoring, So relate monitoring to as and early give talk that? monitoring you just the little it a

Yes, and it. do to I'm happy

talk about we'll So the specifically. JAK,

So patients any have recommended for and lipids is those of all and neutropenia, is LFTs baseline these labs, changes bulk warnings an label to hemoglobin weeks carry to changes, All VTE, monitoring example. they treatments everyone rather typical opportunistic they know these particularly knows, But TB patients serious carry to changes every and when for onerous, dermatologists, I well. of for have which by that lymphopenia, infections, can the this as be of any test normal for the box in patients. to also JAKs, malignancy but baricitinib XX

imagine those creates patients. work office of can that down tracking you a an So lot for

If advantageous at the recommendation a and that's attractive right, makes would for well, SXPs in all as to no relative you different an baseline to approved, physicians there it's normal look are SXPs. We But required for labs inhibitor. category the MS, that is be and and ongoing difference are more market. those of that important think think monitoring patients. and be to molecule to the going We patients something JAK that for

not in to on I'll broad etrasimod that's correspond target with to are changes, activity, just infections are Thanks, lymphocytes don't an just directly hematologic opportunistic serious Decreases what opportunistic we modulation. which the corresponding infections. SXP but they and have in seen Rob, severe add,

a sites, have about building go way sure label. strong clinical we X a effective, can to long that So pressing monitor clinical space don't that. no the fact need have competitive ongoing that there because In think an see And it's and, that we this not discomfort program seeing Phase is that that there, discontinuations, we to do it don't will toward now making the we infections. basis. data, is we do safe, a see trial the and the course, program the on speak we the we're we of real confidently We drug now in GI the

mention I arm. herpes that one forgot Chris and cases placebo mention there zoster, apologize you in were heard is, other the Yes, the two to I

high can One five the for of of rates is higher, patients disseminated the physicians JAKs sometimes to and that and well. challenging in have, as high-end balances, zoster, for ten-fold particularly quite challenges herpes which studies AD these be

study So in small a X is seeing that encouraging. not albeit Phase

much. That's helpful. Thank very you

no remarks. Amit over I call back are questions. now to there And closing the turn will further for Munshi

effort Great, pipeline want internally people thank the this you. a I and lots the all in work of we program. the opportunity quarter patients the and tremendous and external all to We in program. I investigators lot commitment this this the executing to want involved environment-related for trial, work ADVISE thank to take with issues. this learned home through the and also while the start by from entire across thanking our remotely deal team tremendous

to We Phase upcoming of on our forward and X look you plans are move to details calls. excited incredibly sharing to with we future

So, safe. again and thank everybody stay you

Ladies conference for call. and gentlemen, today’s this you concludes Thank participating.

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