Arena Pharmaceuticals (ARNA) 24 Feb 212020 Q4 Earnings call transcript

Company Profile

Participants

Patrick Malloy	Vice President, Investor Relations and Corporate Communications
Amit Munshi	President and Chief Executive Officer
Laurie Stelzer	Executive Vice President and Chief Financial Officer
Alethia Young	Cantor Fitzgerald
Martin Auster	Credit Suisse
Kennen MacKay	RBC Capital Markets
Joel Beatty	Citi Investment Research
Yatin Suneja	Guggenheim Securities, LLC
Joseph Stringer	Needham & Company
Joseph Schwartz	SVB Leerink
Patrick Trucchio	H.C. Wainwright
Chris Howerton	Jefferies
David Hoang	SMBC
Prakhar Agrawal	Jones trading

Call transcript

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Operator

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

Patrick Malloy

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

Munshi, Joining our and me Stelzer, Financial Chief our call on are Laurie President Chief Executive today's and Officer Officer. Amit

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

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

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

Amit Munshi

Thanks and thanks joining everyone Pat, today. for

and couple as In Board governance Nawal as go then go Chairman jump our completed on of across both and of our we reached data here of track XX treatment January program structures that in the eosinophilic derm Phase named introduction with the Garry our the expect olorinab data and we announced specifically to continuing had program XX October thinking trial cardiovascular we we Dr. into monitor we for the ELEVATE COVID-XX syndrome, in XX UC as highlights UC to the but Let through trial we trial to we CAPTIVATE and of pain quarter. etrasimod we'll second expect atopic XXXX continue continued in continuing of at forward for our we for enhancement we studies, and seeing added and esophagitis in Neil associated Phase of the about Phase to results back ulcerative another data forward. Arena. that of XX are continue the November first Q&A. CAPTIVATE those bowel and all in abdominal temanogrel, Today, data data the QX and readout expansion Directors Earlier milestone our month, January we excited and the also as our well in XX, in we this Xb had the of participant colitis Board me as olorinab Xb programs. right In enrollment readout from Ouzren key and and company a XX in our key we dosing UC topline look impact the Xb we're irritable back VOYAGE this

quick with that move to let's So Q&A. synopsis

Operator

[Operator Instructions] of Cantor. the comes Alethia from first line Young Your from question

Your is open. line

Alethia Young

taking, continued have program. to my congrats and guys, I two on thanks the the for Hey progress of ELEVATE questions

abdominal pipe, needed about or study and and of how the seen to there? kind just light we've what in the And with on then down you current coming bit probability what's just bit the about I talk big analysis what is ulcerative potential colitis? which going olorinab, obviously will we a about of a there these think several pain picture, something one success that's little just this think you and First be wanted that is Thanks. talk can little in readout for of

Amit Munshi

Sure, so for hi questions. your thanks much Alethia,

this in the is and of in plateau study. XX% of is rate hitting patients endpoints the basically XX% or in the included percentage On the AEPS scale scale one endpoint AEPS a the

continues very patients studies and So baseline used Phase trial. we'll to changes threshold getting be percentage compared care like XX% categorical placebo a well looking change that show will that X it the were like be in in AEPS [ph] and of Phase as from seems the scale X same will XX% to [indiscernible] at is

are far As Crohn's progress Crohn's. continuing as on is concerned, we

shown We ozanimod in expect you'll some looking directionality we're X population. data dose sub recall, there activity, of in and the know starting year on as later the indications is this terms the from of dose some the and to that might We, response dose are UC to study from Crohn's see mg trying of pushing from dose. in we additional and taking showed and warrant mg mg activity that for activity mg know We a have we to the X that and this that X efficacy for well As looking initial drugs X X mg. recall higher activity show in there Crohn's, if population

in looking So we're the the again, later mg we at look X seeing X data and forward year. to and

Alethia Young

you. thank Great,

Amit Munshi

Thank you.

Operator

Auster from Marty Credit question of from comes next line Your the Suisse.

open. Your line is

Martin Auster

Hey you team doing? Arena, are how

Amit Munshi

Good, hey Marty.

Martin Auster

you to what mg just is Alethia's that mg of that uncontrolled interpreting data of and arms. Could little dose I you on bit follow how to think Hey, about up sort on just with Crohn's of just the know given this in and X terms trial, about think well at comment sort wanted X Crohn's a response placebo you as success studies? that question the if had road you is And Crohn's? dose you of something beneficial UC X future and going kind be to down the dose in the responses then study or mg you've historical a is in think would preferential observed also looking

Amit Munshi

placebo rates point I is XXX top that XXX about seeing the point delta on about remission a a Yes, of range, to range standard. [indiscernible] XXX have XXX a point to of considered bit a little --

participants start non-healthy contemplating talk the through absolutely, we'll we'll be study we're those least colitis will over study, seeing part an looking broader from The the being aggregate is And it the trial. So well efficacy, is to we ozanimod we've terms about again, dose will into it into interesting, at And got taking seeing so least consistent and with we we of preferential comparable of see space ulcerative that We're terms the as increased taking atopic that X if have we're also to mg is agency. in this time of versus activity that historically comparison in open as we're the be of seeing be then for seen get point response what our a if ozanimod. going more first derm as will X to this as we've time. in study volunteers. safety X profile analogues X we label consider at or

guess a of there lot I a flexibility of also So, in and is flexibility lot gives treatment. of clinicians terms

over important we haul. that's the So long going think to be

Martin Auster

Got it, great. Amit. Thanks

Operator

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

Your line is open.

Kennen MacKay

out margin? our on Hey as and ever guys, shaking how recent stage Thank get atopic to just we'd and derm May the is of relates and how approvals trends taking hey SXP evolving maybe your be JAK Amit, and orals again, you. some that's cost attractive love inhibitor it and landscape for the call for the questions. hosting this the setting thanks to of sort

Amit Munshi

has more that the only despite Yes, we as moderate-to-severe it. events, increases the in of it's of know ulcerative evolve agents I DTE -- oral a or than even in has development say we penetrated less aggregate used course know with physician rheumatoid [ph] see significant the in fantastic similar arthritis. etrasimod wrong patients the with that And understand population. of risk the in to is anti-TNFs. market continue the and behavior, moderate-to-severe continued as to poised know suggested Thanks than cardiac Ken, compared really data are safety We colitis picture seen issues practice to increases safety X% what derm the that have the we some oral of and in and we've as increases we success and atopic research well population. substantially atopic to malignancy as be to derm other including and appreciate earlier And profile classes

believe day positioning with think etrasimod scores studies with the cross favorable comparison that profile a be from continue all trial again and derm able see our once line very again, X what long safety oral is in of we term of and will So market as consistent a the with in historically. seen a we depiction with to atopic IGA the that's caveats to Phase etrasimod we

these So, cases. that we remain and incredibly for and product impact will fit optimistic this about opportunity about where deal to the really market the chance

Patrick Malloy

we do next can question? to the Operator,

Operator

question comes Citi. of next from Your Joel from Beatty the line

Your is open. line

Joel Beatty

the Hi, thanks questions. for taking

reason study? one the we is a potential the lymphopenia of first Phase there trial, Crohn's mg is that the arm X of IBS-C see Is in differences on is saw any in question second atopic readout might to expect to X disease a of dermatitis discontinuations be there versus pain. the IBS-D? the -- The on then any IBS in results up load And the coming there in

Amit Munshi

Joel, Hi your for question. thanks

for recall, there a lymphopenia a at the single discontinuations investigator as site, had derm On XX of about at bulk issue the patients these primarily discontinuation. sites in these a you'll study we single had atopic accounted been

think don’t issue. etrasimod we this a So broader is

XXX we're that. with across other the any not all patterns over programs clinical sites consistent In even fact remotely across seeing

at much single careful too COVID I'd of that beginning be a So, not the the predominantly site extrapolate to from pandemic.

from additional a site, lymphocyte that know protocol grade which a X X Phase into single our lymphopenia decreases X get study our we think to that again the a as volunteers it we for lymphopenia discontinuations from don’t XX% mg, that grade healthy at patients far of violation. study, disproportion As will was were recall a about predominate XX% and drives

X not change expect again, reductions to mg nominal from either. mg X see lymphocyte there So much X don’t with mg we and X at we're lymphopenias to grade in a seeing

can we in to the a as across healthy volunteer again, issue don’t see see trials. we systematic expect our study and this So

your Joel, please? could And sorry you second repeat question

Joel Beatty

from other for thanks was and on And to differences question the then expect any olorinab IBS-D? IBS-C details. versus those Yes,

Amit Munshi

see X Yes, at point change across that [indiscernible] so where somewhere placebo been the the about IBS-D and on scale just you in range. programs, AEPS major all historically has

see IBS-C to the the compared in something the in change you X.X X.X to placement IBS-D. setting On

So see slightly to directionally more what treat seems be to do you difficult populations.

we'll So out. the how plays see data

the used pain is then been pain have other in think most setting impact the big motility programs that secondary of the difference been tried is I component. have a and predominantly to the

primary reason that of the is abdominal pain. this pain do one for accounts component. to these with is has the gastroenterologists It patient Here fear XX% gastroenterology number

first different But populations opposed we to motility the first then do when be that about the and slightly here, clinical see think data. programs. pain we previous see thinking in in about pain different. will we'll patient reacted differently to So They those secondarily. But thinking benefits result we expect approach as have

Joel Beatty

Great, thank you.

Amit Munshi

Thanks, Joel.

Operator

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

open. is line Your

Yatin Suneja

guys, Hey questions, thank for you from two me. my talking

then the was CR Xa dose response going update First a each in us a the dose. to CR are AD with response, to olorinab the I after regard give nice are formulation formulation there can in AD? take And on but on you an Phase where PK you not you side, very think was there clear dependent study

to think receptor you dose So need achieve just occupancy of in you what effect trying of to get level bigger you. what that sense you study? Thank could a this achieve at

Amit Munshi

Thanks thanks questions. the Yat and for

we're studies that to manufacturing done. continuing CR additional the CR the our on get stability, On work formulation, have

but we and previously, bridge study, ready working and working we'll for Phase and derm to atopic X the plan we're that's current assumptions toward study. As into beginning the of the bridge our not It it. as be into we've able be said the will derm atopic expect to

mg up olorinab took XX for XX the study, pointed On knew achieved and difference in as Phase you we XXX then see out. safety XXX arm receptor that we the and didn’t a we coverage mg and sufficient arm Xa

Phase above. XX the took dose below we the one For Xb one dose and

the we do response, bit a hope of to a for really XX little and was see sort again that dose anchor So of coverage. receptor

we'll idea data, of study. see coming Phase that was see that but the out that the again we data when So, Xa

Yatin Suneja

thank you. it, Got

Amit Munshi

Thanks.

Operator

Joseph Springer of Your Needham comes and Company. from next from question line the

open. is line Your

Joseph Springer

the Hi and our guys, thanks congrats for progress. on taking questions

clinically alopecia on secondary X can score year, a Phase Thanks. the that considered later readout SALT responder the of tie frame meaningful and expectations around into So analysis the perhaps you endpoints? help kind this the and date of readout what's

Amit Munshi

yes. Sure

you you universalis So totalis types know, and and and areata alopecia. alopecia different of of as types are move different toward there

benefit bag improvement overall mixed We'll on and Xa patient be which this a and to So we'll in Phase be trial. respond helped it from Again, Phase etrasimod. different the us be, of patients meaningful for these small will exploratory objective more across scores have of looking and think XX%, SALT the a populations. the those Xb XX% Phase patients we are are Xa with improvements XX% program understand likely and

we'll categorically meaningful So, be or Again looking that that's would SALT at. a XX patients be be of would SALT result. XX what kind percentage achieve a of meaningful

with cautious inform the be Phase identify Now, the designed help study in us studies. in patients program, Xa small the and Phase with. over olorinab, Xa interpreting clinical step we us forward move did like just help let's really to next on the right to They're

So again, or ourselves see a see know so Phase on Xb level forward educate We clearly is we're cytotoxic clinical which fall across the -- intriguing. now where an the to we so hair CDX/CDX SXPX we our subsets can that and response biology patients, they gradient we can program. these lymphocytes know think traveled different to like [indiscernible] we on is to extremely target it's follicular positive that on go there begin on of mechanism we'd and

to data that excited of be be So patients at. and for it the see compared changing to and by SALT we'll placebo that differ subsets looking will score, we'll looking again,

Operator

Bank the comes line of Jason of question Gerberry America. from Next from

line open. is Your

Unidentified Analyst

for dose? hi, your just I you data, label. Maybe looking people your taking the comparable the something signal afternoon. cultural this an is formulation and talk Oh something second follow mg, Thanks stronger Phase ozanimod on Phase X are about versus Crohn's. the, you to [indiscernible] is X a ozanimod CR mg readout? you to expectation, This are inherently good potentially in for would from [ph] And cross on you one first do open questions. X release, questions, which expectations, Jason. controlled question you going to both for up looking X formulate Two better Thanks. Can the seeing for with on be then for or do to also comparison mg etrasimod if able are our X think end

Amit Munshi

[ph] Suchi for your thanks questions.

we X see titration from digit an the the those Crohn's offset, changes, first for show absence schedule, have issue advantages over but Crohn's least advantages mg faster given being be the titration study to On broad with seeing we effect that with we and a to see that's of potentially mg no schedule dose would inherent of mention drug-drug and issue Naturally not mg, at response. single metabolite think faster interaction to commensurate this heart the the able of outcome range see us. onset, we'd rate and we the for will ozanimod X X the etrasimod a have, like great X an increase and to

if think I those So, things. we saw

tablets the and is to in that original no before into formulation, mg studies see the call. plan. and taking to in call and X CR X making effect of between kind definitely money a if from starting can begin but that that spending There's plateau we Crohn's actual that dose And again, can The at we're what X X confidently we replicate of the to with clinical bunch in response X X a into that absolutely point want a very in think win CR we're mg. successful mg, make we mg once mg X at I the some in formulation we're that studies X saw where program. we we place human

as in So, looking we're derm work is the inform, actually in but there. a doing X as technically about we'll not whether at well our atopic take X mg, feasible the let Crohn's, data us going we but to Again, and milligrams lead only potentially There's which feasible. not to consequence nothing in to that. data CR have multiple will it points be

Unidentified Analyst

thank it, you. Got

Operator

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

is line Your open.

Joseph Schwartz

influence patients enrolled they more select and might like OASIS towards compare that All talk those fairly patients believe a the think similar apparent anything studies involved me of experience of the be aspects how any would couple bit studies. sites are very to since who in with most or baseline to patients. and more I maybe the to time enrolled IBD A for more might OASIS the other biologic might right, said questions with pandemic those ELEVATE over thanks these that biologics paradox I speak experience motivated. the more in tend that who share were in much. the to you've This slight you Can on strikes have naive terms in would geography, characteristics that maybe severe who skew as and about a trials gained you treatment have counterintuitive that results?

Amit Munshi

thanks, X only of as haven't X been trials that The us. inclusion What X the and is X being you'll of similar the before to similar is kind Joe. albeit most ozanimod this, disclosed we The we've or range had about across baseline Phase population. Sure as XX/XX patient characteristics same, and XX disclosed note OASIS were done in OASIS. the we criteria to had the which baseline provided and contemporary characteristics months trials

you So, and small you that's programs all and pandemic maybe that you you then predominantly a which notwithstanding, we've get European to is U.S., when run consistent XX/XX when European programs X and to are XX/XX the and some split get sites, sites, which saw we to go what across Western Eastern more Phase closer global, programs, split seen.

up same the with split exact So did. might end we ozanimod

of think don't much that's a paradox. So, we

have and patients of moderate-to-severe therapy. this shared a even markets years three we've never received biological run two major in couple out does that data of Our advanced for study suggest that couple of UC we've a the times, last

XX% consistent. think market what consistent looks like we think XX% in range. pretty with the that's to We that contemporary that's So

of the study. just run handful sites, around same is but can we're the in And a there of effectively the the same studies. has is everyone's handful that a site historically finite probably challenges these wrong that the terms word there, of the around been selection, In subset world, sites in world there sites of one is

X pleased be really other using maintain sites, have we're of timelines. the world enrollment be ulcerative to and be So around conducted able space, in those the still to CROs Phase to and the many in able sites colitis experienced investigations

of of the site assurance As of again sort enrich you about conducted, example. read. was I kind And play And know, feel critical research supported studies criteria, to for good the We more feel it last out didn't patient population going it pretty selection. good think we're quality seeing a the over we the out. that's all endoscopies inclusion we about try for market locally the centrally are programs but naive across So metric that's way and the of these what play of half we've conducted couple the contemporary a patients by is We to years. let

Joseph Schwartz

monitor this really thanks. you of That's then, pandemic. know potential impact great. And I resurgence helpful, Okay, continue in the to

you of assessment terms from induction so was just us data color the any phase how your far if in give could updated discontinuations seamless collection to wondering study? impacted I of transition it's or maintenance the So patients an of the commentary of around

Amit Munshi

the pre-planned discontinuation we've below parameters rates, that shared of that pre-planned think publicly metrics those our I statistical ongoing are Yes, the expectations. all on basis, all an other and we track interruptions, is all

well longer the discontinuations moving are our patients and are or moving across statistical example, forward, expectations. below above the studies, to of statistical pre-planned expectations from kind again for those XX pre-planned So at board. our interruptions Patients

of the primary was terms of and pandemic, every as site, watching patient, we we're every conducted incredibly beginning day. of our So been we're in have this the since from worry country, got, monitoring one every area every day we've study carefully

Joseph Schwartz

work. Thanks again, the good keep up

Amit Munshi

Thanks it. Joe, I appreciate

Operator

next question line from JPMorgan. Fye Jessica of Your from comes the

Your line is open.

Unidentified Analyst

you group, populations? on you for or forward, than in Hi in still Jessica greater advance mean product placebo Danielle plans guys, the one would APS take questions. your terms where taking thanks IBS-C corrective it to this either for is your What IBS-D. of the does program Fye, this X no both scenario signal point In in see

Amit Munshi

it IBS-D IBS-D corrected is right? setting. corrected the below lower on well the X what Like Yes, point we bar see change, in are said, depends the placebo in the much Most I products change.

in seeing something seeing quite the and is space the D the remarkable, something is of So more worth X.X very substantial. C X in at space

So, again previous mean same threshold both, is mostly. which around was asked I a question is the area the little they the different,

about, let's a next So, since and the go data data and look see program, we it's how call take at to where premature the make we we until judgment the evaluate go good, lower. the X where be We we next. again is can hypothesize barn, X.X able to understand around, is unequivocally IBS-D much can say really good, we barn but is the a

so across two doesn't have And it board. to be the

Jessica Fye

Okay. Thank you.

Amit Munshi

Yes, thanks, Danielle.

Operator

line Patrick the of from from comes question next Trucchio H.C. Your Wainwright.

is open. Your line

Patrick Trucchio

Thanks, good afternoon.

and can in the update First, trial this is study, give the positioning of overall UC to of competitive status is trial an us this etrasimod GLADIATOR in mild the on were how important market? UC what's you becoming moderate how increasingly overall,

Amit Munshi

GLADIATOR and XX it. It's up. program modern of topics. otherwise one Patients for it recall be The really on a not our GLADIATOR XX. you'll question as was or of I population. qualify who more to designed patient Great thanks might for ELEVATE favorite appreciate bringing

site be GLADIATOR to and And running is so initiated. program up the

We updates. will to progress provide continue

the which ago tend despite received and therapy be on self we program. selecting study an has over two on enroll to run being broad don't population. the provide The don’t continues XX at overlap moderate GLADIATOR of and into will XX biologics, still know, the XX are moves enrollment we'll this moderate-to-severe and three broad you study patients XX, XX, more patients provide subset back As is program. to those continue to so out of progress important and the but an that the qualify XX, as sites penetration updates, reason a of running It few to for is updates the I patients comes they to something mentioned advanced the be minutes haven't

clinical of endoscopy, with still bleeding These on So active risk ulceration are enough to the they're actually studies. the have study. frequency. not but severe for clinical They significant qualify in patients not captured

market the to the So with going study forefront important of we and significant colitis. essentially long term very are make and GLADIATOR think that's we after these the this with our patients successful The standard desire addressing doubles, a of those patients being GLADIATOR. outcome at also that and to landmark think be etrasimod the makes we'd very care

Patrick Trucchio

preference helpful, cardio commercial and forward wondering That's areas and how then how collaboration, about picture GI, Arena's we out. a a with which sense think building collaborating be derm in going area of just we I'm these the the potential and there's of kind strategy on, to keep question, therapeutic thinking of make compounds regard bigger specifically development. areas potential should should if with of on to versus various three of focus collaborations control and about within

Amit Munshi

start UC a would indications comes too. into then andEoE staggered is that's have first, build. say then question dermatology, cardiology GI that, additional of into we coming Yes, is I after with great we including enter this that the advantages X. Crohn's we and a Phase some one entering things that,

are not Phase X all these are cardiovascular just are programs pace, same now. So they at initiating running indications the the

X three in lot Phase other they in So these total of will indications. a where be phase

think potentially, portfolio cardiovascular, term. then of to as be things to out go hope have the So we'll stool and choices portfolio choices we're anticipate have fair assumption we that make building future, going will situation, long in be today. if it's in definitely and a not the make, to We'll an leg important a we to make

of about it but of the So the time you us build right gives build go. have most beyond guys way a to and to to that footprint and how important that's horizon investors company in scope having consideration binary thinking to, to five of outcomes want the terms talk the single are really or an the not assets XX-year we're you a of if company, in that company

that's there's you therapeutic need, and multiple think want advantages, areas, you want think to key we have and by actually in can You to we before portfolio, you've a an go where medical and can diverse into these that provocative got ourselves be consideration think therapeutic unmet broad areas and competitive where you you of yourself execute each we big execute by a area.

that recently Neuroscience, We know, to we with and called again to licensed and that not asset able it and physician United out community we that Therapeutics better different was to we spun we therapeutic partner. area breadth scope [ph] we that's highly incredible directly. PAH required of of As that Therapeutics, And now into patient Therapeutics United our the and and population specialized you out spin felt and has product skills a a hands in of Longboard and Arena [ph] be a that were thought our that's and chose Biopharmaceuticals area Longboard a level out. focus knowledge,

things execute and that mid-to-long So we've prudent holding can we over we term. and to the pipeline think continued decisions on decisions make prudent to prioritization the

strategy. the been really that's So

Patrick Trucchio

much. Yes, that's very helpful. you Thank

Amit Munshi

Yes, thanks Pat.

Operator

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

open. line Your is

Chris Howerton

review year? obviously at earlier report just the of must kind couple I One your so reviewing from them I colitis just most this there, I haven't but your us of for then was you're I just JPMorgan conference a admit, cash chance year, that, about great ESG this frankly of you point maybe transcript to if talking this give your view is of mean, what but from the Hey and maybe position, and was question, curious report. a runway I us be, in were cash couple would a you thanks have a of could had second the think from actually asked that And does kind highlights I ulcerative taking me. questions. this been commercialization? get point, to of the

Amit Munshi

Sure.

So, let me Laurie to out it about and runway. will me ESG to take then I talk hand take cash the

term. a free are importance lot multiple level ESG in of Many audit feel peruse to of process board conversations the know year long we We side, of at in that. the report On We so took issued a Long terms of and had you the XXXX internally. shareholders as shareholders. the ESG last ESG our pride going through

considerable we of We amount concerns very shareholders their seriously. have European and take a

process So of smaller governance to highly feedback means made between we our on report social footprint. improvements this XXXX later we've our footprint, critical this terms like for be what We'll a started ourselves environmental, issuing company year. XXXX two ago, be and broader our understanding in years it on and And active that and based XXXX. in managing engaged

be So read to report. second able a you'll

So we're by that. extremely excited

we what internal are are and the improving sustainable governance up that's always up a long got Laurie, this. level. take set the for have term executive we're you We've an company. the runway level trying is we board, sure we we're sponsorship again, constantly think building to important a who cash And We make our want and to board the on side question? footprint do as to company, vibrant to

Laurie Stelzer

sure, Sure, with absolutely. predicted year million. in We at landed our had cash. we we $X.X operating the ended Yes, billion $XXX as burn so about

We to imagine, haven't guided expenses but continuing are our yet you as for XXXX, grow. can

we're program Phase a planning the number as of well as progressing of pipeline. AD X programs are looking to out We and in the the

us burn, cash than a to certainly but on more it's that have we point. straight to picture cash just commercialization complicated calc get a So

Chris Howerton

I great and reviewing I said, like I Amit, forward already. look for Well, right. you're it company asked and worth, And that. taking you questions to really of report, think think have ESG the just building the I it's been most appreciate all seeing I Okay, what a them.

Amit Munshi

Thanks Cool, welcome so much. feedback. your

Operator

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

line open. is Your

David Hoang

and question guys, me Hey, in. fitting taking thanks for the

putting maybe think you then Yes, Just do to could at whether A a the the population. this addressed about of the And timing be you mean, the in you Phase forth UC assets, mild-to-moderate a talked be market there, has by X had an first on a on there been registrational prior questions, up space? in approval study. given that lot obviously terms looking a also but GLADIATOR I couple. mild-to-moderate might are few oral follow

Amit Munshi

Yes.

in I'll information smaller pivotal a scale, has That's but some that. generate to done multicenter no one No has a ELEVATE, same So is clinical it, a We've here. this and of running by set we'll call with a have global investigation itself scope agency. terms generated scale seen one in large have as study? the broad anecdotal data studies the conversation

at we pivotal, need is least we So trial. we've this to it a registration a were got single have opportunity and we going second pivotal a the to make think will question if be

I the double for big have think design information. program of two only meetings in a more payers country. generating eligible GLADIATOR this create a does it dozen into provocative space, been it that's case about their We've input to a We've for importantly, had a driver community. population lot we with spent around this but the the and probably peers the the of position key time of etrasimod. with taken begins Not the peer preferred to

multiple like it's of we type global points don't important running with trials, running are I from So else view. think And see scale large we Phase equivalent anybody GLADIATOR. X

this I population. So the think of or near are forefront exploring at we

David Hoang

touch on to know the and the able readouts preview, to as then if maybe be design And endpoints for are asset, well off, just would I you temanogrel? just we're the little wanted a the assets. great. cardiovascular but APDXXX, Okay, wondering still as ways I new

Amit Munshi

Sure, into so moving both designation, have Fast we're Track both Phase and temanogrel X.

be we'll to distal the looking resistances the patients. be a as we'll microvascular actual and looking site quantitatively, at and temanogrel, in we're subset of Just taking looking at obstruction, the those occlusion recap, patients, of be we'll measured to patients, at

we cath the that setting. really clear lab, And cath and be metrics of ejection and cardiac It in also in lab. fraction, with the And international an similarly, APDXXX international there measures of this of trying then so, those an that's study. set be real will space, design look for will hemodynamics. we're possibly no to can change in output Again, develop quantitative as in

So we'll setting. controlled be to able again that in a do

as both studies those to concept those both of of program. work to really proof the So where studies, timeframe? are inform, And of data very are and readouts the terms with next on in a begin important in agency designed 'XX registrational to go

David Hoang

the Okay, continued questions congrats thanks and taking so for progress. much on the

Amit Munshi

so Yes, thank much. you

Operator

comes next from trading. Agrawal from of the line Your Prakhar question Jones

Your line is open.

Prakhar Agrawal

for taking X the And had Phase Dupixent? trial? here you. testing such on etrasimod congrats been you to as has what for the relative of EoE, shown I the in my some doses what thanks of questions a all terms success what's by eosinophilic in for ADVISE count, and are in bar the on progress. couple Thank Hi, reduction injectables

Amit Munshi

thanks. Yes,

love meaningful. for GI overall with efficacy other of substantially time. esophagitis course once etrasimod be that think than same in the eosinophilic explore reason it eosinophilic we'd up animal of And done door the the experiments day what worse quite to to we see So us a biologics? we've opens to that's the conditions range. Biologically, from And don't over advantage any we would see

done So mg mg X study. a we'll exciting we we supported be And by etrasimod biology think And Phase Xb incredibly and X have and is to there in the date. exploring study. it's

sufficient So forward be amount it move of a there? registration to should yield from able information to trial into

Operator

comes the Fargo Jim of Wells Securities. Birchenough from question from Your next line

Your line is open.

Unidentified Analyst

[ph] questions. for Hi, This Yananjiu thanks for our on taking is Jim.

a And ELEVATE So design. the re-randomization first, the then design. trial question trial this UC on of has treat then XX it's type induction, different design, through maintenance the typical trial from

the study impact Thanks. Treat-through how the loss patients I don't new of the obviously the being are design, at sections, step, you who that of up because endpoint, historian for was because make patients outset any powering didn't for wondering, add with of So they maintenance the design, responders. the study their wondering, certainly, And was maintenance and how, more there just with typically with your patients of by phase the study? to all non-responders. from I re-randomization just respond or starts typical And definition, the traditional add the patients does XX-week

Amit Munshi

U.S. for on did maintenances. and your consultation don't more Treat-through the life, that extended re seeing drug goes we to biologics that reason an real the the drug stay for Treat-through responders the Patients also closely a well The important dichotomy European had dose re-randomizing historical enriching design versus and it thanks. induction real mimics authorities, the you on start the early context, with for offs world to do remember drop really maintenance. population and the your after back over Yes, is more patients who adding and in different the period It's randomization of time. regulatory both right? real In

So you And at then reduced a down X to remission case had a came mg/kg to why originally Infliximab bear. had of is, higher study induce mg/kg. that's to dose what that design you in do the X XX and to to

powering patients. more require it same maintain right, does requires You're to the

to have drop in the re-randomized. middle about You six get you delay offs have months nine more a and patients as

with subset to So efficient the way with around. in treating smaller middle. importantly, nine just patients and the the is We achieve design more powering six lose less a all can dropouts of the months not same

think competitive more going think a plan, And accomplish what the and of a from agency the picture So able in we're a advantage. like with less that's we I gives more working to maintenance it's streamlined to design. also It with the clear looks terms important. be conversations really world and our more trial physicians and through real that's much of statistical

Unidentified Analyst

lymphocyte you this by or a in SX have and couple efficacy if lymphocytes mechanism trying of a peripheral a reduction? might you that key while the lymphocyte AD response, kind you And two Thanks does like Got didn't a for reduction of a surprising first a you of then X you explore may, you is also I higher maintain program. in study maybe it, reduction, questions efficacy make of result Is very guided and the helpful. as side mg in increase know, you have the XX% incremental think reduction. Obviously, the it that's have, talked AD. to for the dose, and on a XX% dose doses, at class the mg mg, about And to profile, you on average X XX%, AD step the function same kind increase you have an it sense personalized to want signal, dozing, then

Amit Munshi

Yes.

debunking are Keratinocytes. cells know a start me The modes activity let and like of with drug including PD has this for types Lymphocyte multiple reductions Dendritic against So not drug. a action, other cell sole has - marker a it we notion. preconceived

counts XX% is same for something So is to lymphocyte category about in know we size. that fixate in all historical over analysis the general. educating the effect And continue time just We counts drugs on. lymphocyte really of on all only something across investors that incorrect, spend from just trials, to it's account

junctional in protein. SXPQ know open with target close. and role products, example, we being junctional proteins and junctional competitive So seen there's multimodal able cell-to-cell activity, for barriers SXPX a plays critical cell-to-cell to we've activities Cell-to-cell of

terms focusing going So it's probably on PD a in on. lymphocyte is important that just remember by reading of themselves counts to marker what's over

well. require are XX the threefold all We push therapeutic with for also know colitis JAK different that ulcerative recent the than data doses different and most inhibitors, doses AD a they areas across trials. trials in to the is mg those now for they and and X example, mg trials. different the higher up The rheumatology as for their dose did XX use in Abrocitinib, they example high trial

based the derma first settings, that the points So way atopic these after. different we different different know you the great a all dose. new. indications, to drugs. in derm on different need one, anti-TNF the dosing atopic autoimmune is of SXP we think back the key, probably indications been one early as drug that's specifically that's about there's learned have ones with nothing going to go conditions, And is, two consistent yes, on board indications, doses dermatologic and And range go modulator. We the to a into your lessons the key broad the which we have And of we're more

Unidentified Analyst

you. it, Got helpful. very Thank

Amit Munshi

you. Thank

Operator

no to are back Amit Munshi, call the more this questions time, President over CEO. There turning and at Mr.

Amit Munshi

to momentum XXXX get Great. drive XX next Herculean things continue XXXX. forward resiliency the to months. as a everybody look drive catalysts and we with and staying a the done. difficult effort the to focus and we in to Hey, I thanks forward that into It at their call touch continue staying on everyone their key over want to hope everybody, was We Arena team, really our was is energy safe. out joining call for today. I just for year; our

and So again talking soon. to thanks look forward

Operator

participation. Ladies call. this your Thank you today's concludes and gentlemen, conference for

disconnect. may You now

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