Arena Pharmaceuticals (ARNA) 6 May 212021 Q1 Earnings call transcript

Company Profile

Participants

Patrick Malloy	VP, IR & Corporate Communications
Amit Munshi	President, CEO & Director
Laurie Stelzer	EVP & CFO
Kennen MacKay	RBC Capital Markets
Chi Meng Fong	Bank of America Merrill Lynch
Jessica Fye	JPMorgan Chase & Co.
Joseph Schwartz	SVB Leerink
Neena Bitritto-Garg	Citigroup
Patrick Trucchio	H.C. Wainwright & Co.
Yatin Suneja	Guggenheim Securities
Roger Song	Jefferies
Joseph Stringer	Needham & Company
Prakhar Agrawal	JonesTrading
David Hoang	SMBC

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 Mr. Patrick Malloy, Vice President, Investor Relations at Arena Pharmaceuticals. Please go ahead, sir.

Patrick Malloy

Great. good and Delfin, you, afternoon, everyone. Thank results. joining a chance for this announcing XXXX us release today, had you afternoon financial quarter first hope we our to issued and we Thanks review press the

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

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

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

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

Amit Munshi

to I joining you Pat, Pat thanks, as today. had outlining mentioned, strong press the Thanks, And the and a again, call the last quarter. release for everyone, chance our review during hope progress

to we're did time quarter, more and right Q&A to going we're be spend -- last we have jump able As that going to to directly there. and move to and

the to So with to portion. Q&A that, open the back I'm it operator going hand to

Operator

Cantor Alethia question our Fitzgerald. first And Instructions]. from coming [Operator Young

Unidentified Analyst

Alethia. Nina [ph] is This for on

of wanted you're running there trial. the studies perspective the how COVID environment in light items you have that? as wondering to So navigating we are monitor to And any in on ELEVATE UC, your just fine-tuned get been while this we continue

Amit Munshi

it monitoring X. Day been from We've

every patient off every a our Some and we been concern. every of over We've patient team XXX sites. data study of site we've day, to our manual. had and before heard primary we've across trials me And monitoring integrity, about And on may both took monitoring you them for for integrity. automatic talk always study how monitoring been put XX-plus countries safety, conduct,

were XX. we the that. complete We to monitor in UC to enrollment able So continue

are ensures UC we assume at time. have it very, last, now, could potentially last XX. We patient on level. monitor track for or that we very on that impact the as XX to real have site COVID any And that level XX, just measure mitigated I And and continue months is a

trial. impact COVID encountered -- haven't over COVID type XX the we've complexities last through because we the hasn't not because simply been of to the So impacted It's able months. simply manage

Operator

RBC. question And our Kennen MacKay is coming from next from

Kennen MacKay

again, actually, both label atopic and you sort had landscape And ozanimod was of UC, more and potential ozanimod it's have wondering I just could impact of very evolving etrasimod. from risk warning in a And we've properties, least I'm as good do SXP on different space. future sitting. even what Efficacy there the seen sort of you look Two UC terms on the of competitive approval, where black anywhere and around questions, doesn't Is of kind at previously in from sort an what box there, quite any derm. of as perspectives think? of the

and to so JAK and very physician if that read-throughs more separately opinions. around there TYKX the whether there and inhibitors And space color could class? any derm, any kedazil much similar questions, there worry are the AD in but P wondering Just then is in

Amit Munshi

Sure.

yet. the ozanimod don't On haven't their They seen we ulcerative approval of full label, impact in colitis. label have

first black could black it the don't generation interesting box across board, to have be. So, box The an of the what a SXPs even risk is question. compounds. difficult comment on The

black the a have So MS I label. relative to does think ozanimod not box --

previously it ulcerative -- in in believe colitis. that I Nothing untoward So hadn't in would find happened the box UC that we black a with seen to expect setting. difficult MS

seen the have across board, far, That's JAK no we monitoring inhibitors. well seen abnormality. So effects siponimod Both cleaner than first-dose SXP labels. ozanimod first-dose have we've differences continue expect and so in true. certainly label also AV the monitoring true dramatic that the heart and modulators having being a rate that conduction a did to We've requirements, despite first-dose as not pretty as

the the SXP broadly, all JAK with the know are the dermatology has discouraged community a in physicians relative profile space. space, bleeds what ulcerative way continued is seeing despite class. that initial JAKX, in that arthritis the pathways the strong What colitis various uptake large and the to very progress We profiles. side inhibitors, we effect So the to the classes. into which from agencies IBD rheumatoid have we're it's safety really we're sensitized the your seeing and encouraged whether is And is JAK modulators by within TYKX, JAK question, the viewed derm JAKX,

are So like in But markets running X, black we labels those up and risk look entire the board, fall JAK aware, they across includes the that -- category. as the And same see malignancies, were what look VTEs, that in they're indications see JAKX, malignancies, TYKXs, pretty all JAKX, once warnings serious we'll dramatic of -- across the infectious those on are and class. those like. those you're we'll those box well once events, the what

of waiting agencies be terms to we we'll through So once work again, in see the to issues provide more more color we're those able labeling, and how have clarity.

Kennen MacKay

Yes.

Thanks, thinking you. for like from this. the sounds doing It Thanks all at. hear we're where thing. same to good Amit. Great Sounds we're

Amit Munshi

it. We really appreciate Kennen. Thanks,

Operator

question is America. Gerberry coming Jason Bank of next from our from And

Chi Meng Fong

both XX-XX endpoints and I important second the is would mix what more mix far, can well little on to patient expect set this as of the it's first case, in the perspective? on primary you the the on of Chi guess the looking be from early clinical from we biologic between same Phase observed Maybe data that's trial support approval a remission on ozanimod that do coming response question can question which a A for based you you and the patient similar perspective, the separately, of out for couple trial mix naive just you study Crohn's? Jason. you're with regulatory so expect the too If is the clinical on refractory release, baseline? to the II endpoint, readout that is is biologic CDAI tell? a a line expect year. Crohn's study Would top whether at endoscopic of at of and to guess confirm the feel X score This as the to or maybe the sites be commercial I the later both and

Amit Munshi

On primary and at looking a endpoint, be reading the out. CDAI improvement. endoscopic are those both both we We'll of

important important commercial The think as point really Crohn's, us this I so gives of and from response confidence looking at it's wrong which And to case, probably more is the looking II those that right vedolizumab. us to to going the that a view, most far relative Phase taking the for be question to relates to one's regulatory class, question of in this we're the X II of development. across be that's be stage is And it Phase in study. which as or that data. both. And As indications. in a fact next looking for we'll to both other at forward agents into dose we're ozanimod the relative We'll doses move

inform II a a the A, study. for II purpose of Phase guide especially and stage So Phase the study to next study, as help of substudy our really the again, is defined as development is

it's are uniform. to It's tell. As early. far as The patient breakout, sites tough relatively too

what comment what patients percentage of it's but bit be and naive patients able So to are that. of early are on too to percentage we'll pretreated, for us a see

Operator

from coming And our JPMorgan. Fye from next Ms. Jessica question is

Jessica Fye

sense together, us between when substudy give of get sense there in the the then times I'm we can expect another? one inevitably ELEVATE get you year readouts. us And released trying different be the of how read half ELEVATE Can back remind Phase much you to will from of at we if sort a III that both the Phase be expect update or the of out and better studies, data? Crohn's should time should A IIIs a slightly to on whether they'll

Amit Munshi

of in that we A have readout. simply we're Thanks, year toward know before because of end the kind we'll to the clock that will we data But -- substudy we complete announce don't Jess. how as soon and evolves. We as that trial, historically, said the just the enrollment start as enrollment

and XX separately then expect we've be year, the all all of guided and with is in to the aggregate right now So to XX and of that do. before. time thing yes, that's at end to all the we -- And that out the announcing But read the details same probably both the prudent about together. and spoken we'll we've

Operator

And Leerink. is from Mr. Joseph Schwartz our SVB next from coming question

Joseph Schwartz

so I again, guys. really on important format in this like many entirely innovating call Q&A. you're ways, focusing Once

and alopecia who's study. the study patient Could a in Phase maybe thinking data on you this include order be your best by bit a to about areata you're in types talking III? how how determine questions So and couple different of ongoing start the to analyzing the you'll little about

Amit Munshi

release. the completely guys format. able actually Joe, and you complement a Thanks, press Yes. to all the on read thanks for We are figured

need a now proof-of-concept So entire Right we the study have release. study. press XX a to an patients. reiterates single it's dose. didn't AA basically which script is The It's

be going that. actually a a puts at it's need. having with a not in and totalis of small the to arm, XX treated in will But X you're patients both that patients, scheme universalis randomization have We of Even subsets you lot patients. more alopecia patients patients areata all study

think these of is the class going every this important that remember these drugs one it's I to first of in cases, patients. almost time into So it's

universalis the might these patient a want how we We slightly or scores also make underneath. different XX% let's react want sure very diseases totalis areata range with versus differently. experts there's heard XX% as patients and the that talk signal. there's that with XX% very phenotypes say SALT in Alopecia these a in about different sure in to react these benefit. make We've in do to And differently patients be all to trials. the So field higher actually

-- new been a So taking a drug it's directional. again, into into a Phase exploratory IIa you're an study, that's area taken disease when never

to where to to study. I we what trial that XX-patient after start take begin with will able seeing a across groups point, that. we'll be of we effect in But all set group, So terms III expectation one inform just Phase if want see your out of that our versus effect to

Joseph Schwartz

were as some we of things, these helpful, That's Okay. wondering too.

or the is measure So for if interpretations? ask that different are score might anything on study confounder this be just you've more to into you to a going introduce due control physician that control anything you might one for I the study identified to extent that subjective was could or just -- variability curious, else might some what during SALT program. Or that potential able doing for? I be natural the to potential that

Amit Munshi

Sure.

physicians used used So to that to of form. scores doing the SALT that I area actually are are studies doing whichever AA -- to how alopecia body think is to subject in calculate understanding has percentage and

lot if So on setting, we're alopecia of for you patients, scale, a less the you remissions. that. is do get mild worry And bigger the down more far spontaneous areata push worried in too example, meaning about the

in variability more there's that much to It's placebo difficult -- more signal -- in get a population. population. it's that manage very You

So the more are of which alopecia totalis severe why universalis and most areata course then and to the severe. patients, the we've that's stayed patients

whether thing proof-of-concept I you very of that, sense not. the a or to And get do a So that's study. Phase is doing right the for good active by drug think IIa

Operator

Bitritto-Garg our next from is Neena question And coming from Citi.

Neena Bitritto-Garg

if you release next and kind the little could steps program. when kind about some with for bit curious a steps of next just formulation controlled we the talk I'm see that etrasimod of So of could

Amit Munshi

program, CR upon best-in-class further cardiac the to effect. you designed recall, our was So as improve

effect atopic change mean a beats derm trial the under placebo-adjusted X heart from study, As is just our you schedule. saw in rate that titration without

trials a that very the PK/PD So effect And or effect The we of are work And various that next how -- is so --. have the we're first-dose process changing heart out this doing was Those reasons, release and original we're drug. of rate this don't dose as already trial we the The premise configurations, a looking We're game terms to we good the further of in can whole different without the that. with ongoing, coming position. formulation. even a in multiple pharmaco was dose of develop slew solid discuss did for diminish at formulations. formulations. premise overall step in the originally patent soon continued strategies all it and we our as of plan a liquid

Just of variables is the exploratory group that quite here there's substantial -- number looking of the terms at. in we're

to want go as Everything that it's doing and been to there's that, and, forward conclude. meaningful look we sharing definitely B, we're make and So has benefit on. more A, that encouraging, we forward incredibly something experiments to that money some date spend data sure these multiple to

Operator

next Mr. Securities. Jason Butler from our question is JMP And coming from

Unidentified Analyst

esophagitis. few is [ph] a This Warner had on just eosinophilic I for Jason.

predictive the a of EoE what's on models? rationale for patient if opportunity, Just broadly, the your preclinical trial, any And enrollment etrasimod updates VOYAGE for in the And market could more in then sense give status. then any mechanistic us you view?

Amit Munshi

Sure.

of couple a things. So

enrollment. start slope, it's the you know. a It's updates guys just enrollment Let slippery We don't a general as provide me rule. with as --

at to it is in both we risk So and EoE as One indications. modulator colitis. EoE a a risk SXP was is rationale settings. the key early higher first study these forward was ulcerative cases, on picked again, patients derm UC, as taken atopic question these picked UC patients And atopic previous same why really is was and and bidirectionality to that observations. has derm between of we enrolling I atopic borne of to The asked, derm. AD a the moving And the reason potential an the in setting. develop out time the couple higher develop into at to been really of the

directionality. atopic as whether And whole perturbing, that and by and very biology degradation. the So were common at types there looking see EoE. that we both at types same We it looking mast we the are of of that cell experiments, cells or these barrier -- we degraded cases, ran to clear both a went function of cell in IL-X some we type And was IL-X, diseases the we the barrier eosinophils, and was derm were were were realized series function.

of dendritic of types food. migration. in antigen probably type some UC, the see EoE, atopic migration In cell case reduction dendritic cell You And the challenge. derm, we've and of In bacterial a insult. of shown cell dendritic case both uptake settings.

of diseases of T Then and You across cells. they're you the see and as the see as the specific CDX, cytokines both well subsequent ThX as all of pathology activity set the models activation reduction on strikingly ThX and actually a ThX similar. cells, activation or CDX. of whether the the showed lymphocytes, animal very a consequence, mast eosinophils these And are ThX, cytokines. And all

eosinophils cytokines, a mast And and that the derivative So against an etrasimod published. -- we've We've also of disclosed been tried model. the all showed that's ThX in again, activity, I that etrasimod asthma believe compound previously. cell.

diseases same have over over of over. the effect this overlapping of So these and pathology, we've in set seen all and that

it was a United responsive addressable longer of understood. us we are probably about grow will disproportionate to subset kind move markets enough patients are are We as this patients. patients larger over to that direction. the there's in approximately provocative EoE disease a think We those to that to with amount no continue XXX,XXX Today, derm of the recalcitrant And PPIs. better to likely XXX,XXX and of know So be is think incidence EoE. in the of high-dose States, time, in XXX,XXX patients globally for

patients I fits as actually diagnosis of basis. many the definition better, see becomes in as you'll EoE. an recalcitrant is that have we'll And better again, something autoimmune more and those so, think see understood, diagnostics disease cases, GERD And of the

in So think we're the There have of it. several And once-a-day excited up about course, oral, significant are studied we there. with incredibly being a space. a we'll biologics leg

Operator

from H.C. from coming Patrick Mr. question next is our Trucchio And Wainwright.

Patrick Trucchio

actually questions Just on of follow-up couple EoE. a

Phase symptoms. improvement on VOYAGE the endpoint, other of with see study of biologics of seen level eosinophils symptoms? powered you'd to is on a just context Because Or a what the cases to certain I'm is DSQ of And benefit actually secondly, some score looking of the on III and show a in confidence the give then just be we've be you terms mechanisms the of study, eosinophils, in in particular in would advance a symptoms we level see we looking but there to for where So knockdown to knockdown trial? of don't wondering for? you that much

Amit Munshi

you've last that the of space, less clear we I'm We then be looking TGF-beta of are cell assumptions well so I But But that a day, to general going relief steer cascade types scores. that which And that, antigen you've that of of whether haven't at nature again, far eosinophils eosinophils At cascade, present be disclosed in that's it's thought results study, I that and to specifically. the got end you're that important atopic to the similar having presenting consensus symptomatic important you've cells symptomatic the powering cells, fibrosis the are disease. cascade the the going experts and whether looks, the into are one in some very far ahead around dendritic are these think the one. more patients. Recall present to got of in occurs field. think in insults, the the the derm been where of got

You've cytokines. got then cells the and impact of ThX/ThX T

it's the definitive And that for interesting; the disease because diagnostic you on esophagitis -- marker eosinophilic eosinophils. and of upstream you happens marker. the the All and called of eosinophils, it's look histology,

But that are the than symptom cell causing for these condition. involved, to specific just focused these relief. all the counting across one if all just name an our type. upstream has of we'll be symptomatic thing other And is the downstream the relief rather the opportunity then of into important cell mean study the of eosinophils. of on and that's other count disease it's more what's it's doesn't types types, much and because the implications literally hypothesis it's more etrasimod type And in number the going all cell You of work much

see you When really T just you to holistic see a think much beyond macrophages, disease. specific this more see view. you in at I histology, lymphocytes, of CDX, types look have cells you eosinophils take CDX you other

there's going in more this action. etrasimod's of play strengths So condition, much we we in on think of and that'll think mechanism to its terms

Patrick Trucchio

it. Got in then And helpful. just That's really etrasimod and follow-up Crohn's. a in on UC

own, if the ahead wondering a indication in launch first the again be the I'm can -- as just Looking remind would And on launch just us years this few on you commercial discuss label. your plans, could to partner? the specifically or is intention you here, look UC this to to potential

Amit Munshi

Yes.

this upwards And intend strategic Japan and it whether alone. terms So been go We've for we had it's in years the plans working own, now. team a game medical partner that -- we've game of for Japan. need continue ground venture now and are through we a joint few we're for what These has And stated X and of years a of affairs U.S. it questions a U.S. our and Japan. commercial to plan our in team now. we plan whether and on the intention open Europe, the part the But been or in to quite our will for on Europe. be go a launch or Japan alone previously

at commercial really how payer intelligence We're the turn working organizations switches groups systems dozens Again, around launch for as the it's of The of interactions. value-based of most parts the do build doing, had is market, deep payer intend etrasimod the sites, off. of the small to a we've we with experts role begin investments with of used and into would balance don't organization, across hire can Asia. build example, Phase broadly, And had hire perspective in excited years clinical what a cash the interactions our actually have start really this almost artificial of to etrasimod people many to commercial that and think product we and them We U.S., means are luxury luxury and things in infrastructure the be for examples to small this years peri-approval investigators, market we've a happens and MSL those in had early. specifically. you III, study. had IBD. being commercial systems level. and academic the gets infrastructure turn because why the who the just field, commercial, over on to etrasimod able enroll get getting in understand years X And help a early, or critical. GLADIATOR studying really of invest insights critical. And we little for that future do, of success context post commercial companies build won't see period They local We've sheet before We've launch marketplace. so the it's tremendous of relationships. led about multiple a from important of modulation important now SXP the to luxury think companies using Europe of to the switches time, market. early. the it's Those doing to late. to made those failure We've have building absolutely long-term a of company over very clinical that a the build able launch. on XX and companies for our building MSLs and aren't in or until literally thousands we've had success organization had which that the just success country helping It's alongside to clinical is to I too And take And value to it. which long We've understand what you we and is trials, engage to that the program, -- the investment that engage market ground

sharing really our I'm to launch. lots pleased and we closer get we're details what to as of around look So forward doing we as market prep, to

Operator

next of Suneja Yatin question our Guggenheim is And coming Partners. from

Yatin Suneja

to dose the of And the you X where how can wanted gating development into dose there milligram are atopic Is just X for dose for fit could I when that dermatitis strategy. that sense the some the milligram factors or III the program, if what AD Phase get etrasimod a in consideration the study? -- of the start? give some color

Amit Munshi

Sure.

hopeful regulatory study world. design, end So concluding the those on that by around start duration. multiple interactions, factor really study the regulatory in the gaining We're we're size, that's study alignment is of the just to year. discussions And gating

we've to overall X that we regulators before, do around would a milligrams we the point program. of in As discussion How to like with the the spoken is explore world.

all pending -- the study and we're some share as the with So various of to I'm those guys. in some regulatory interactions, timing parts, control it, you end details a start be all the we'll have really we to position we we as do soon can't, of excited moving before and can the we those expect clarity still year. of from about which

Operator

And of Roger our next coming Jefferies. is question from Song

Roger Song

have I two. So

of about assets So the can the you first one in CV is, [indiscernible] your cMVO? terms us and remind Amit,

Amit Munshi

Sure.

of partner compounds drug mimicked beta-X And the to that prostacyclin the was course, has and of to X.X-fold found be ralinepag Therapeutics. fantastic some is long-standing other with oral and history designed a know, X same applications that had indications. receptor. cardiovascular temanogrel. once-a-day half-life started failure. progressing group with as have United APDXXX J&J's a we're forward compound selexipag move in their Phase the landmark The antagonist, in multiple we of the you research is the Arena application a APDXXX II heart study. intravenous that That acute a And other to in IP decompensated are area. on XX-fold developed potency data in ralinepag. had that compound, X.X and So cardiovascular It That

function, cardiac holy believe which we animal the hemodynamics, output failure, in acute no that in compound at in suggests in be heart that setting a least humans. Here, fraction, really should cardiac would change we have improvement with in ejection hold up grail

excited So have we're very compound. designation We that fast-track for that. do about

is actually The a to inverse in temanogrel. X-HTXA we interaction, second a blunt PCI compound site the Temanogrel patients. distal is STEMI aggregation of X-HT/ vasoconstriction and the X-HTXA believe and By can agonist. non-STEMI blocking we platelet

a designation. drug the II. also moving has this fast-track compounds So Both are into Phase

We for late the expect data both compounds. XXXX in

unmet need. we're We So this. where about to the we to long another there's space for white company excited very in areas of stool eventually form assets the progress term it's for foundational company. continue novel think tremendous leg medical And think the it'll

the extremely programs So, phase and company Phase Is to couple II what early next the days. we're over means years. excited But the and to an this we'll We're of through the building out, about continue give everyone update them. on

Roger Song

about of excited additional the I'm to etrasimod. Yes. outside Awesome. assets hear

And the question So finances. that's about great. another which is

prepared you're having understanding of and already the readouts So, Phase year, a course, you're next III commercialization.

the -- year in commercial of year? What next of and from are into R&D of Just help guide kind or us the terms ramp following potential the kind the us. maybe

Amit Munshi

on Laurie the Sure. is CFO. call, our

to let you. Laurie, hand me So that

Laurie Stelzer

guide last landed $XXX did We year about at Sure. our cash and on million guidance burn. in

what We are is say haven't given advance. but our guidance programs we for I XXXX, can seeing

progress. and our AA, our seeing our so AD Amit EoE the of in to our And CD, programs. toward We're year. spend imagine we'll we that is and said, continuing end so We III, CV as that advance increased the continued our progression programs, began and Phase our as have you portfolio can UC whole

all yet, -- seeing progression are in we but haven't million given last and we $XXX guidance we So studies. year, our

Roger Song

all me. All right. from That's helpful. That's

Amit Munshi

CV Thanks, Roger, the and questions. for thanks asking

Operator

question And from from next Company. our Stringer coming & Needham is Joseph

Joseph Stringer

missed Sorry this. I've a on areata follow-up if results. I got alopecia

terms would be SALT the in comparison In terms compared been out score, of some that's a rates to the reported? when of data come the for it responder fair of JAK data

Amit Munshi

Yes.

option, we risk I caution I would the penetrate patients broadly think the areata. the malignancies profiles no of the to of willing the totalis different vastly to VTE there SXPs over where be. that be and what and and the universalis case take Clearly JAKs potential for other so I be the increase will encourage not term and the long in think risk is safety events. market of are in patients that ability alopecia think might That the MACE the might JAK terms in

physicians So to we the profile patients think believe JAKs, able clinically of in to that's show of profile. If completely modulators. a create safety with modulators use to that something effect different risk-benefit a with risk-benefit relative think there's and practice. an That, I would clinical combined to SXP choose different profile kind meaningful they SXP we're is

So early we're as to ground we're with EoE, breaking derm, tell breaking with atopic very as and we in we new atopic new the are derm. here again, because did ground

So, early days.

move we'll risks, in we that like. how terms talking of risk-benefit profile really talk able think what being leery always without of physicians to read decisions. that's know I the ultimately about more But will benefit and to looks as patients that I'm the out study because just and make about

profiles because So that always could is comparison direct the I think different. a look difficult risk-benefit very little

Operator

next our question And Agrawal JonesTrading. coming from [Operator from Instructions]. Prakhar

Prakhar Agrawal

a had I couple.

too -- temanogrel started. on First recently

it GLADIATOR that you're there thoughts. the relevance the the thinking Curious indication? in Is could thoughts generated? So be in for UC, about on, about launch? needs in IMR. be think development going your the the that this endpoint be change Will opportunity primary look focus just of trial be as key we moderate trial design to secondly, could your path access? And on of what should curious the awareness some sort elements the of I when predominantly like to the on barriers commercial on And of what

Amit Munshi

questions. Great Great.

conversation mentioned, of Phase is ground So index I on rates temanogrel, this these robust the we both microcirculatory forward with there III of like. what supportive endpoint. allowing will us registrational the look terms and want because We'll drugs initial to where agency. very the will activity options and you in study, in simply cardiovascular as of the be a itself we're been the terms because these II resistance, go are It's have in for here, really They've or focus assets not IMR. and our patients. designation, Phase of we're incredibly new in we more actual moving regulatory speculate And quantitative is see to trial here, a patients. understand fast-track reperfusion don't by few It indications exploring If at a measure. able look breaking

site we've IMR ketanserin, available of time post-angioplasty an antagonist, States, distal X-HTXA looking seen quantitative improvement something the seen specifically United that tried vasoconstriction. a So, injury, older to be agent and in in has here. longer the will no the at an we've the perfusion been first Recall

mechanism. an seen different specific class using improvement this class importantly, drugs, we've this So saying way, hitting maybe or a it similar of a or

So go would have we'll series of to a it go U.S., reason from good what like. ascertain experiment. a then III to us agency program there, conversations, gives the look run global And Japan Phase Europe,

range patients the severe who space. GLADIATOR, UC call -- terms of flipping patients. of the to have life. don't more the and These to they patients unaddressed active part, disease. very moderate steroids, that criteria meet significant not but their are in end steep disease, existing maybe studies, active these currently much for -- the but They definitely about it have still meet moderate the These with the for inclusion we'll it for tend very criteria patients are X-ASAs impacts have In experiencing addresses for, back, GLADIATOR very are they XXX,XXX on most disease pulsed

risk-benefit given with opportunity etrasimod, And access our address So broader here a think these actually we helps access. to this think about we and one launch there's From terms a things profile perspective, patients. we would real and been is how of of help an we value for potential story role that to already the the payers etrasimod. in have overall future GLADIATOR doing talking of our

So a we've in that of spending don't preparedness, time a GLADIATOR, commercial be about work, to I And talking as on, the specifically early lot talking talking about payers. barrier. mentioned been it'll think we market

from benefit in these terms available. the of care a that potential In These treating of money, patients current fact, excluded standards of be lot patients. currently us cost we it'll and they're a are think

So reduce cost it payers, patients. care like delivery and of it'll specifically for folks expands the the actually networks, these pool, many for overall integrated

Patrick Malloy

next move question? we could to Operator, the

Operator

Mr. Hoang, is next our question from David And SMBC. coming

David Hoang

Just had a couple.

lead see you dose that further dose? that development of wanting was open-label events milligram specific for essentially be the preclude A that there's Crohn's if anything I wondering substudy you might just So this to forward? dose, set would helping expectations with to that would the of later in or terms would safety that flag that any -- in Is there a red X things take for year,

Amit Munshi

to it Again, comes Sure. back risk-benefit.

If argument milligrams see a profile the see adverse in of to that versus will X just take of no milligram. dose from strong that forward. a forward with efficacy be we move rates X X a the perspective, we'll milligrams milligrams. cost and then in definitely X we the efficacy, There's time have events dose higher single married So and safety

advantage dose be On having up throttle able the idea dose Clinicians the other down. throttle multiple love competitive strong to hand, a to to a doses. there's a and

going is out all we a on it's X means XX% from milligram know about we the additional in to milligram, see play lymphocytes. decrease -- X mean XX% we to so and lymphocyte in decrease it's far are these healthies. side. see So risk-benefit a Again, on change What in the count,

out types other before conduction SXP we'll the at look issues. patients our we we modulators some be that X healthy that to to looking I of cardiac out cardiac at any any lymphocyte are we get a as to studies, there. milligrams at of infectious in point serious lymphopenia. We'll or at X will So looking looking counts, see of lymphocyte seen have cardiac, volunteer patients, aggregate Grade counts. of the be percentage be issues with issues We'll

from of lot whether not. milligrams expose a risk-benefit milligrams We and have the room place X see up. right do a come go we we'll to we to those back in to the think safe So play or patients again, is X patients. question, And

David Hoang

builds That's little a Got bit. question really great. of that it. that off helpful. And a That's

there's class SXP, as that with a we know So lymphocyte effect. depletion. That's an on-target

seem translate to not does it infections. to opportunistic However,

infections with And that to nature. AD, might that case through weren't been II and anything Phase the things Grade the your I in opportunistic of And consistently that's there so Is any X trials. events seeing you system? JAKs, think than SXP about something be it's spare where the affect some less might inherently or it subsets literature why been safe immune suggest where the more for immune of in example, even

Amit Munshi

Yes.

are The class immunosuppresses. think I on. that's spot not SXP broad

With we've results not class. and in seen serious whole turning are one you're entire everything JAK across you're infectious malignancies down. shutting specific the down cytokines. events modulation, T bringing JAKs, system SXP results all With the you're to the a and subsequent the in that the the halt, essentially very But which lymphocytes area, which downstream

I works think screwdriver get hammer heard I've a best on the you where of out this pulling using a not screwdriver where we're and is the collateral lot a damage. analogy

specific. more in patients. these Immunosurveillance is it's So maintained

seen haven't been serious the class board, frankly, modulator. an SXP events and not has We the entire infectious think I across for the issue across

diseases offline with for quite references of to literature the there it's everywhere. where without surveillance compound clinical disease quite class. and that a So used again, had can in is comes an think there's oral the the to optimized all in subset bit But with utility this is think in where it's etrasimod single unique of suggesting terms a it's is with be to a we broad really features its broad etrasimod hasn't just be better a patients. you, and happy immunosuppression literature, of to a some it more astounding. historically, go of we think quite but its we're etrasimod that And maintained immune specific interesting point, A used, regulate just of But about etrasimod of fit with bit once-a-day etrasimod And class share back opportunity can't JAKs. specifically. could the really

David Hoang

say thank for really from Really, helpful you context. again. That's my it Okay. providing end. I

Operator

is to And session. call for Mr. remarks. and would like for the President question at point, this Q&A our to last the Amit this over And closing CEO, I that turn Munshi,

Amit Munshi

to for moving to the hope progress today. forward I jumping Great. Thanks, provide as everyone, that the across make continuing pipeline. look updates again. Q&A call And form we we to continue to on entire was the useful

and you. hope And chatting to quarter. next seeing to forward look everyone look stays safe live forward soon. So, Thank everyone

Operator

today's Thank participating. concludes conference for this call. And you

You so now all may Thank disconnect. much. you

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