Jounce Therapeutics (JNCE) 7 Aug 202020 Q2 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics Second Quarter 2020 Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

As a reminder, this conference call is being recorded at the company's request. I'll now turn the call over to your host, Komal Joshi, with Jounce Therapeutics. ahead. go Please

to Good our second Operator. a welcome the & we to release available release Thank the at in conference morning, www.jouncetx.com. call. Therapeutics Investors plan that topics quarter outlines section issued today. This Jounce The which is of you, Media the and discuss website morning, press we

who key Drapkin, Speaking will our Dr. will discuss who Dr. Rich on today's Murray, on CMO, update call an CFO, our our will progress provide be quarter milestones; and our our Beth lastly, by financial results. Trehu, CEO will and President, activities; second followed our clinical review Kim

for will open We your the call then questions.

XXXX. plans the the remind Reform Safe Risk we filings. a that about those forward-looking by will Litigation under these today's and Act Securities important Private I including results purposes various of from Harbor constitute provisions discussion materially expectations, statements prospects our statements may forward-looking of SEC indicated like Before discussed that in begin, of the factors, for to as everyone include differ statements future Actual result would Factors our the

In addition, as and today, as only not our any represent XXXX, subsequent upon as X, representing statements be relied views of views should our August any of forward-looking date.

will update While if the even turn so some point With we our specifically Rich. statements now forward-looking obligation to views to may do I to in that, disclaim elect at these call the any future, change. over we

morning, Thanks, Komal, and everyone. good

and excited share we have in are programs. over while Jounce last progress four made the XXXX, build first-in-class driven to the I'm expect maintaining pleased company discovery a to clinically by both wholly-owned biomarker continue our leading efforts the in also to programs and of We immunooncology clinic, that quarter, we've pre-clinically.

our the about to touch talk want for pipeline, immunotherapy and novel need how landscape we about think I the I approaches. on Before

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pipeline tailored these Our approach translational patient science concepts. on both by are of two and focusing important to populations main

across First, different T not mechanisms immune the types, our just programs novel CDA cell target cells. positive

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biology, programs of own regulatory cancer T ICOS PD-X in Our growing and targeting biological CCRX biology, development CDX inhibitor. to addition ILTX biology cell novel immunology, suppressive T known crucial pipeline as suppressive aspects including and covers and cell LILRBX macrophage our also

are immune cell has at not exposed IO bringing focusing that Our not the note sustainable to of possible be discovery important to Even aimed of the team effort implicated current pandemic, the is current patients. incredible without the long-lasting of COVID-XX challenges tumor not lost response, important Jounce. at colleagues work, effects of evolving reversing would dedicated my to pipeline the population benefits through therapies. that on Jounce work in patient types suppressing the sight our within the our microenvironment is exposed or It

in track Phase early critical this analysis and efficacy interim remain of interim the result a XX enrollment of patients on to we analysis As We in data to on for X commitment, completed more the trial. XXXX. complete pleased announce EMERGE that I'm than July, biomarker the of

the our in as and IO JTX-XXXX both LILRBX This program of macrophage of of as study enrollment LILRBX the combination an or approach is preclinical a also target in Thus a an to we Annual become macrophages. that remain JTX-XXXX patient IO. Meeting. our also binding checkpoint XXXX that T data initiate to to presented be dose that function JTX-XXXX similar an PD-X integrated cells. this on trial for XXXX. well to on predictive in molecules, trial JTX-XXXX in and believe biomarker naive may relevant importantly, as lead IO inhibition believe biomarker X JTX-XXXX example may failure to biology the an of conceptually We Supporting checkpoint wholly-owned we selection. intense on with PD-LX Phase inhibits building macrophage binding immune track the we SELECT, is including vopra today begin in of In was pipeline, to expect area And HLA LILRBX HLA-G. Phase Suppressive at ILTX, interest of announcing XXXX. AACR We're escalation our has X patients. employing

Given this the to JTX-XXXX recent the year. forward this clinic behind into look JTX-XXXX. our advancing program Closely most to exciting biology, this we development-stage addition is assets,

we tumor our novel is The selectively JTX-XXXX these a CCRX immunosuppressive reminder, the chemokine regulatory T cells, selectively program directed the antibody in JTX-XXXX T infiltrating cells. tumor. eliminating cells we first receptor the remove of regulatory suppressive target cells. By regulatory can is a believe, T infiltrating to As brought The barriers deplete at regulatory is designed T cells. tumor on enriched on by

not mechanisms studies. of To a PD-X importance that this potential cell of expect These reveal microenvironment may restore of XXXX, Importantly, fashion With patient setting. and the multiple tumor independent trials. the different of Shifting importance all you therapeutic is from as activity a discovery moment. PD-X June preclinical will immune shown we our programs one Rather, single vary therapeutic biomarker patient, resistance biomarker Meeting remind data to clinical four of in to we intervention immune focus at biology is understanding highlight our immune directed now AACR the IO have point that we at highlighting Jounce the to wholly-owned points will end, inhibitor engine, intervention. Beth types cells, and this in our defined discovery in and for of me continue cell to interaction types that, by system. coordinated efforts driven can in believe establishes in the let

susceptible in now efforts type on active on JTX-XXXX Beth all expect are I'll failure methods. established PD-X novel the new areas and emerge specific and Given mechanisms discovery more These goal every cell programs detail. populations, efforts, see our XX our over of call a to turn to patient to for emergence our inhibitor versus to clinical targeted growing candidate from like development engine our months. we the naming PD-X resistant we've JTX-XXXX with to overlaid the discovery XX discuss inhibitor activities more of now

this to the milestones progress look am come. forward everyone. good quarter, and Rich, morning, about Thanks, and Jounce I our to very excited at

JTX-XXXX JTX-XXXX. foremost, on First continue significant EMERGE both we and earlier track and to we make our remain with and and on development programs progress SELECT

needs reminder data vopra present a both platinum-based the combination vopra path, EMERGE vopra The trial in or on inhibitor initiated cancer indicates development with focus that administration this sequentially. because with hi line to the cells Based CDX As June progressed enrolls we lung to therapy, who to ipilimumab Phase X second combination EMERGE on XXXX. of induction in patients either have EMERGE prior PD-X of trial in third be our and a we non-small work. and T of the T ICOS cells biology, on cell

moment. the For care default of which in is these patients, a standard address docetaxel, I'll

enrollment analyzed supporting The ongoing to at continue data. whole who help clinical and the levels, teams with at EMERGE proud docetaxel SELECT associated PD-X This of the to the at by the In tests overall cancer mentioned, I'm PD-X interim studies that focusing analysis to the analysis data analysis PD-X inhibitors. and very unmet unchanged, and with in have inhibitor progressed docetaxel on cell potential on include weeks which complete of PD-X to are significant XX% X% EMERGE differentiated the the and know the approximately data the to patients, second like include put median completed EMERGE and to and large different X.X response our little durations in to cost in efficacy is and predictive vopra. months on provides have patients second naive, PD-X X dose as vopra you of despite non-small testament need progressed evaluable cancer in Most the docetaxel interim belief now of and third data in our pharmacodynamics most the team naive a line In rates no remains cell engagement designed like XX other will patients. COVID-XX benchmark. through is toxicity. patients outcomes line, least remain will to of of work clinical both review context, not enrollment inhibitor and Rich non-small in patients for are Data of docetaxel setting or valuable We have of lung for the line the them. become biomarker second and We've To over pandemic. interim as and benefits PD-X non-small of from EMERGE; high experienced to XX responded study left. making has analysis it I who timeline the cancer plus to important a patients our in by patients all for inhibitors and be challenges would patients, inhibitors care bring appropriate EMERGE. complete, With data the biomarker do. As the of on default, strength lung clinical interim patients standard the survival nature our lung to treatment options investigators track and growing cell

docetaxel control compared in that to in patients. produced also and PD-X PD-LX from is suggests be rates survival survival and clinical meaningful docetaxel. improved PD-X defined overall contribution especially likely well-defined naive on us the the on will to It these get rate. were based our population. share interim has critical analysis beyond the interim to improvements a to without in naive selection inhibitor follow-up would EMERGE less In to potentially need therapy order a feedbacks in of biomarker favorable into criteria this patient measures KOL However, been To-date, including modest includes of The analysis; past response rates overall predictive no than for Data durability response rate, of but of may protocol of disease rate, treatment the benefits interim IO than clinically works inhibitors based other response with greatest be from overall target resulting evaluation in endpoints effect in lesion and of response. enrollment continuing trials approved that is these thorough analysis many the EMERGE efficacy, duration response survival better EMERGE remember meaningful survival. suggest benefit for IO better important immunotherapies. allow IO of goes to survival or on may from therapy, by single-agent expand the reduction, profile safety in measures these of of data patients, population clinical duration Since chemotherapy, accompanied tumor predictors efficacy compared IO a the

for T At of the Virtual respond. that peripheral to selection of CDX ICOS comprised anti-follicular We these hi and additional potential vopra. predictive immune also on and ThX, set to which central functionally latter benefits; comprehensive whole generation potential a of specialized hi and level the future CDX stimulation We T cells of dose the we the antigen hypothesis T biomarkers. AACR study ICOS the investigate specific correlation occur The is in induced memory, and inhibitors is likely with by and more coordinated more support not the of receptor, pharmacodynamics in phenotype responders helper population role Annual CDX the in benefit. the translational presented contribute an cells, may with for a and T the vopra plan through durable induction data have that memory data believe of for clinical Meeting, central its to cell clinical response, ICOS to June on of The blood do the T manner subsets former subsets. cell iconic of the a patients

JTX-XXXX selection developed ICOS that vopra in medicine TISvopra biomarker and those like to IO. combination with with biomarker we at our would vopra cells patients. towards we PD-X predictive I goal T precision expect TIS these than patients treated was potential vopra patients on initially prediction to to expect JTX-XXXX optimize the TISvopra believe vopra CDX for as treatment cell alone to employ the the and ICOS to hi predictive to our of select to be trial be for a potentially generate designed benefit. emergence inhibitors biomarker is T Because PD-X move and biomarker inhibitors, turn results hi is than selected inhibitor, we likely in and will of CDX durable trial a better has biomarker without been to and The clinical SELECT, PD-X selection. the better the more the Now, Because

to So right superiority then believe directly We the biomarker alone. of vopra JTX-XXXX the biomarker, vopra predictive the patients. immunotherapy and that approach right the effect a combination trial selecting is is vopra the pharmacodynamic to is finding to the distinguish effect demonstrate powered pharmacodynamic a the linked inhibitor, right that JTX-XXXX the for plus of PD-X to using to from

approximately of expect the TISvopra vopra TISvopra immunotherapy cell non-small naive XX% JTX-XXXX XX JTX-XXXX to approximately who that potentially and XXXX initiate be SELECT the enroll to be cell plus trial expect to lung selected second we line and on will We We data randomized using above line We trial. in clinical will patients XXXX. second versus patients track remain estimate cancer and alone. threshold predictive to biomarker for in report SELECT lung non-small eligible cancer the

We trial continue JTX-XXXX of to continue was is of important do ongoing decision one developing an believe strategic JTX-XXXX partial complete one over Phase well for to and year on The responder Jounce. treatment. a X as that

the In the in we our inhibitor. with SELECT upcoming JTX-XXXX this to to plan benefits JTX-XXXX addition evaluate trial to include of a combination trial, PD-X

well-positioned and and and the new clinical Our trials JTX-XXXX Phase to is team across execute trials vopra for X JTX-XXXX JTX-XXXX. the

from steps to ICONIC benefiting in trials and of coupled we're U.S. underway, therapy. patients today's key commitment learnings the taking JTX-XXXX forward outside candidates with to SELECT, developing look XXXX, With IO programs development our translation into U.S. are and our EMERGE in clinical JTX-XXXX As will and not four multiple important the for have Jounce we we as novel from preclinical who the we continue sufficiently

like to to the call turn I Now over would Kim.

Beth, and everyone. good Thanks, morning

cash, was June primarily As investments to $XXX.X and million equivalents we decrease the million cash December reported costs of period. XXXX. in this $XXX.X to morning’s incurred XX, compared totaled press XXXX, as of release as The due during XX, operating

the to P&L. Turning

XXXX were the for The second research million due of compared and external employee R&D incurred slight to increased to and no clinical and XXXX General primarily regulatory partially $XX in $X.XX, of quarter offset compared primarily the Net per development $XX.X of SELECT the same to a by million diluted million of IND period million quarter the is $X.X of second expenses. net attributable net lower fees. basic we in in expenses. expenses for second result same second million expenses XXXX was or net XXXX. in associated clinical share for for to loss revenue trials $X in share and EMERGE lower for an loss in professional $X.X loss decrease increase period the loss loss compared quarter quarter and and to operating costs the increase basic as compensation per XXXX, and enabling expenses The period administrative $XX of and in was license increase was a XXXX a $X.XX. same service expenses of or in During net diluted in the the The XXXX. with the and million, collaboration costs G&A

science the flexibility from to pipeline us the expenses through be our to goals wholly-owned and translational immunotherapy the expect the cash, We're XXXX. to operating capital closing, in equivalents million final remarks. believe gives capital execute funding expenditure existing our our in against our XXXX to for and scientific the of Rich leading cash strategic XXXX. efficiently be Jounce enable of full-year to now four the approximately turn innovative expenses end the sufficient progress to that reiterating and to we $XX platform, call stems on will I We In to of cash requirements our clinic and expect guidance plans programs back million. gross our continue and burn expenditures investments previous operating for $XX

first patients with Kim. we'd the the call XXXX; medical Phase providing that, new Across XXXX; using Jounce in continue Operator? to questions. pipeline, JTX-XXXX upcoming and for to true unmet XXXX core a your the biomarker now initiate filing initiate to from plan critical JTX-XXXX an in in and In of XXXX; half X of robust XXXX, our vopra complete work SELECT and of Phase the X our open milestones. is efficacy to Thanks, of our interim needs, on TISvopra conclusion, advancing benefits with for trial activities analysis the with multiple IND our discovery EMERGE JTX-XXXX and trial of of pipeline. XXXX; biomarker mission data staying poised we With like for continue targets to enabling IND early expected in

[Operator Instructions].

comment or H.C. of comes from line from question the first Our Debjit Chattopadhyay Wainwright.

Your line is open.

you Hey, thank I other comments, simultaneously. your and taking I'm and three missed if calls for apologize the good morning on questions I

through the you ICONIC Just walk kinetics the ICOS, especially enrollment, on the the terms where use? the in do induce of you that greater on or primarily to most the in dose And plan vopra again, ability expect PD-X rationale you focus PD-X you could lessons of SELECT the to us PD-X low X of than And from you. program, XX%? and the emergence, patient just the terms the also, XX to of or program benefits? to would Thank see

Okay.

based CDX our on by hypothesis prime really or ICOS activated work. are to that know exploring is hi T the we CDX cells well, cells that trial T fact SELECT the it's needs So vopra

actually peripheral We called a tumor back the well that blood of to emergence so hi then the ICONIC T go that baseline for those who very found outcome. baseline ICOS clinical the the the TISvopra the had in of those had biopsies predicted best used to in And gene tumor study, CDX the patients signature cells. patients in biopsies ICOS and cells we who identify hi

So CDX retrospectively biomarker ICOS basically T those predicted it also CDX for using data applied clinical our that pharmacodynamic found hi then clinical that cells. biomarker ICOS hi a the to predictive for cells to biomarker, find benefit. the We and

only SELECT threshold. who the using are TISvopra this treat to we're trial TISvopra above in So patients

tumors vopra T XXXX believe of our activated those able able ICOS because patients they be developed generate trial biomarker that a cells are be to PD-X in we PD-X So cells be randomized as patients their JTX-XXXX, respond to with outcomes It's more XXXX was plus for we to originally CDX they presumably so likely hi and inhibitor, vopra. expect CDX predictive should means with to against because alone better to have PD-X inhibitors. a unselected TIS inhibitors, potential than the and

are Debjit, than as PD-X PD-LX for with also in than naïve. that is cell equal Remember, pembro. studying. or data greater there, is cancer So pointed is you the line nevo of out, and There scores or to or one on patients to unselected these equal data second there settings XX non-small and lung we're greater

benchmark a historic we'll see kind biomarker how have those. so good to And selection the compares of JTX-XXXX with TISvopra to

complete and overlap, prospectively because our population, PD-LX TISvopra We overlap. any PD-LX. be may not between overlap some that direct suggests there's are but not There not there's selecting data

highly ICONIC, in all CDX IHC predictive fact, that. whereas ICOS not T In TISvopra was predictive cells, for was PD-LX at for hi

doing be collecting prospectively PD-LX better the we're at look we for. because biomarker we are TISvopra look the any for will we'll but to believe looking is retrospectively, not a selection we what predictive data So scores,

XXXX XXXX make of Rich powered comments. the trial to ask versus additional the is I'll to superiority alone. some So plus vopra demonstrate

question. Yes, the thanks. for And yes, Debjit, thanks

to really expect tuned and to PD-X of just we opportunity likely was as of see expect is we respond bit we to for hi even ICOS a TIS more patients, predicting generate vopra, property arm. the an on for Beth's Just for threshold expect kind also inhibitors, the JTX-XXXX TIS selection optimized better are who what the in of benefit combo. since patients to developed in But reiterate itself likely since the cells comment, more

selection a trial. of alone in increase of on concept PD-X the kind patients, if JTX-XXXX we kind nicely so with really and the you combo, benefits -- the randomized of stacking, in expect that's will So more and of and that

above population, the trial. Yes, and the and in of patients the threshold cancer lung that about to be for we then eligible expect XX%

parts I your of all did question? think that answer of the

-- Yes, it are just much. Data be have Thanks based and to is the timelines, get you terms XX% of emergence very the TIS on in going your likely said are Analysis signature. to XX did. of And patients likely to

So early you should you data the going are how if long released And the enroll it's think expect? XXXX, you to enrolling? it's do and planning many to in know you take think do rationally, we I on how study? patients updating haven't other days,

Sure.

the intend don't enrollment. data analyze until to the So study completed we has

XX that have a study. it we to end have data, to when patients enough be of we of enrollment and time entire believe, in sites, enroll the we report selected We will But able be the have target XXXX. on to by data

Thank you.

from the Ulz or question next comes comment Baird. from line of Our Mike

Your open. line is

for data, of is do Hanley on early the updated that have congrats the this XX our a taking know kind of a said for range you be this and guess, Mike. do with more would I an of top-line weeks, Colleen And Thanks a you data include a the would for then that preference if for just on any then medical what rather Hi, you questions have Or at quarter. TISvopra? thoughts the result. meeting? have I be biomarker might idea EMERGE And XXXX, the upcoming follow-up? progress you on least

Colleen. great Thank I so questions, mind. know, everyone's on you. the burning that's Sure, question

on and getting interim for the data analysis. work just planning starting and we the enrollment So we're finished to in

weeks range done. the will last wait at patient is until that XX second scan in will be the basically So their

the June of Now, started in year. enrolling last studies

of be can range more the a to or So year up data.

the will that the package. So study, XX the it getting cells, the ICOS hi biomarkers engagement, built into -- target we will all really last scan. so comprehensive week analysis that patient be include analysis are on it's interim have TISvopra, interim And a really data that CDX the their triggered really

data will of And we'll do the and next on still as more so But now, that in for the get to the how to we closer provide we track release interim clarity analysis. where year. around we're beginning

Thank you.

of Fargo Our Birchenough Wells Securities. next from line or the question Jim comment comes from

open. is line Your

Good Nick morning. morning. this Jim for on It's

Just to for go back you a to question the and SELECT notwithstanding fact almost Debjit. answered

I So if to took -- to a at enroll six await looked about data patients, we and it EMERGE, months could approximately year in then XX further data to mature.

you immediate as just patients through timeline? them? walk prior can trying of all you're to almost So us enroll then the can are And screening I confident in enrolling this patients how such to compressed many you twice do mean

Sure.

we clinical sites per site when how we per look trial. that's in enrollments, to in include So month, about terms the decide we and of at metrics always many think how trial patients

we've we So timeframe that be for pick to that able set in we the enroll sites the ourselves. to we need number of think

lot of a are there So unknowns.

failure right. rate But have CRO of what absolutely in timelines. feel and confident now, You're We'll as screen very our to is. our see the we

there this obviously the was challenge comment observed And to trial? not that's EMERGE, balance also negative ICONIC, But between real going then PD-LX rapid tumors? there and missing high in couple is big in tumors the of back And drop-off, able are just a questions Okay. one apologize, being challenges you I ICONIC point here. PD-LX very is there on a I'm patient of a to and in -- if

PD-LX scores a the scores. again, certainly any who have will don't terms failed in these inhibitor. We But we PD-LX are baseline of PD-LX perspectively of restrictions patients analysis scores. all on do PD-X efficacy based So have on remember,

is at what are we're So and tumors. there looking archival

how will look certainly know question. it. informative So I but be, will second don't your we at then And that

forgot just what I was? Sorry, your question second

big second was Beth early one drop-off? ICONIC Beth, in problem was, the

drop-off, early yes. The

Yes.

any would about you're And so that comforting be I that? EMERGE guess seeing not comment whether that? to that and make can you

Right.

cell second cancer are don't comments on failures. is anything inhibitor So we It non-small line make like patients. a lung dropouts usually they enrollments any But that. or PD-X or

obviously report we -- report will So when be that data. finally we will the

you. Thank

or comment the question from of J.P. Cory line Kasimov next Morgan. Our from comes

is open. Your line

question Gavin on had This the good clarifying SELECT morning. Hi, a is on I just study. Cory. for

I there XX% Can all TISvopra patients above subgroups -- of think is a just comment is you. Thank is you line that it cancer that you the made of line within patients? of correct? threshold. XX% And lung be patient that's second will that second this group? the clarify Or XX%

Sure. No, that threshold. that data from about above general, that sources. is of cancer be would comes analysis non-small line just data And lung our different across cell of second TIS the expectation multiple in XX%

investigators feasibility about that Rich of will very where as one that potentially with is well. this And attractiveness and we're of back very eligible, and So, lung be we've a X%, those again, there a And Having population. in absolutely five X%, the the easier. have patients the X% have be was comment very, been lot drugs eligible a can study. And reasonable. been a question ask about talked to approved excited that in very patients successful the cancer difficult apply kind of felt to Nick's lot trials, getting make enroll. study to to of XX% I'll they

of another Sure, side the think itself. that yes, I question Gavin is population

frontline XX% make off So established be we therapy. continuing over But think about appreciate will firmly all as just are threshold. of just it inhibitors PD-X the to we

more those as a therapy. treated, line and of of needing are next need patients failing those are patients So of really -- dire in more of

that in say, growing sad docetaxel, Beth? market that's into it's of line number alternative benchmarking have importantly, that patients to in market, we're of that the entering therapy. terms mentioned, kind Beth of As the But patients as of this line to a we of therapy. at look

think trial, think directed more are the the I I but that comments PD-X Yes, failures, Rich -- to your EMERGE

Yes, I'm sorry. Beth. sorry sorry, I'm I'm yes,

for And SELECT.

Gavin. was I that, that extrapolated bad. SELECT. I comment that EMERGE, -- to to am a on was to making That apologize my going for Beth was

Yes, as to but be EMERGE trial as TISvopra retrospectively we it could apply in well. at are to the well. the looking trial And SELECT going

in PD-X levels a the experienced PD-X getting naive about inhibitor population be TISvopra we'll lot SELECT. as So well as of in information

with Asia is Okay, make then more of more in Eastern like site; geographic terms trial or ex-U.S. Europe the is great. this commentary you on, East the breakdown one just can clinical any And or just broadly? there

their is be but clinical to part them I people the a trials. Yes, to it's in is Europe. we'll all we've what on only it's but once it's of patients on be And clinicaltrials.gov Eastern on ex-U.S. sites tremendous get the most cases see in getting PD-X primarily mean desire found in able will way posted inhibitors, there's of

actually feel making fact that those an effective need really to places. I good available patients So the with a in we're therapy about

you. Thank

or question from next of comment Our line Cowen. Boris Peaker from the comes

Your open. line is

this is you talk you're I one candidate? plans development combo about for that for Boris. for [ph] call of Vidya Can a that on me JTX-XXXX about thinking And on hear types Hi, are more that the tumor your particular a there And JTX-XXXX. thinking of you're on for quick of candidate? Maybe exploring?

so with plan progress Sure, coordinate channels, one. sure. I'll a that our take of and we as biomarker any we or programs biomarker that Yes, analysis.

predictive analogies selection to of of a at with we run to continue evaluation looked couple kind ICOS broad as is there the the to as broad there'll that's tumor So -- of types. biomarkers for the well And looking program. of be based a program, on be vopra will ongoing kind how pharmacodynamic and

there and interest identify macrophage investigated a available that about -- are of of fundamental biology What there is to we for can't So course, all signatures suppressive that's of macrophage our is a us. be great data programs. course, that's say kind to tumors of within data

there of Phase exactly we program X. do from patients just in indication patients. intelligence XXX the to what a is do So that, patients that's competitive can has view, through XXX observe some go We program tumors point in we of into, we clinic expanded been Merck haven't will XX that. there's yet stated from available what information know to That will

watching tumor very the September. information at into having of particular at ESMO program And available Merck presentation And end be is a about taking so that We'll types. there's be particular, forward how that carefully. we'll

independent a publication that well PD-X. generated data on that showed have On came with PD-X is could that side as the we this as biology out think be of as combination mechanism preclinical that, PD-X in that of we as there well the

directing as we come out So that we But specifically, tumor there's think closer. more we of where patient in get there important with kind go some into types populations. we'll is biology

Thank [Operator Instructions]. you.

Our or James. from comes next Seedhouse comment Steve line of the question from Raymond

open. Your line is

line Great, mentioned hoping analysis, patients you congrats if was could also all interim and on also, completing think this metastatic as patients as of I second cohort I advanced enrollment well. patients interim any just EMERGE Thanks. And of locally or metastatic? are the in for are you clarify EMERGE. is they then third there are line, the analysis all or

Thanks, Steve, very important questions.

they all, all of metastatic. are First

and received have disease. inhibitor all to So regimen have platinum-based a these patients a metastatic for PD-X

second line, some them And sequence. in regimen them be if platinum they will in of they've then have so received received frontline, but could plus PD-X also

chemo So line. chemo second have inhibitor frontline, gotten PD-X rare cases they inhibitor could or PD-X line, frontline, second

of second second and lung with mix line a of they cell third will -- non-small cancer metastatic. be all mix they patients are So a

designed specifically, superiority on can the the Okay, helpful. vopra I on for if versus that PD-X on is guess the for there vopra plus which powering Thanks. powering study PD-X alone. of wondering particulars you you just effect endpoint? size you're SELECT, And I'm share and mentioned

Sure.

will a detail about of on how people to than that. a think So powered enrolling, starts do the we providing to help lot more once about in formal explain a sort plan results But interpret starts Q&A. I'd rolling. I think more rather a the and setting do just in how and it is designed study start that once we study the

the EMERGE. speak last in there everyone on the dialed did maybe And you just to dosing? analysis patients doses allowed or the question sounds use receive just Can ipilimumab back generally good. in of were then interim ipi that maximum of Okay, any cohort

We're that Yes, now. I right don't know data. even can't starting I together. actually data pull comment the on just that to

Thank you.

of line from Our Debjit Wainwright. question the next H.C. follow-up a Chattopadhyay is from

is line open. Your

thanks Hey, back for pulling in.

lower the have interval curative. but of due you PASC to conference especially totally not how bound EMERGE of really follow would for is a and the into PASC, define So terms in the you ruled study, success UC out

to pretty has want in the would historically, encouraging story if a data I'm four you again? mean, get I just to wondering so revisit so UC, And been that

Sure.

So the second one I'll take.

the when to As directly the overlapping. have But cancer was vopratelimab we urothelial it got you study. had in originally in really dosing know, approved, planned

follow So we interim of will the once we see analysis, the results the data.

So if it those other suggests types that be tumor out. might there of I rule interest, wouldn't

the we're lung the analysis in now, of cancer As on interim focusing patients.

in about people the defined in calls today's about time the really success looks question is specifically what the first I've defined with respect EMERGE protocol. criteria because like, curious are your for earning we know So original so that what to

space survival modest analyses So from following therapy. in have appears less rate lots impressive what with is predictive the we've but response survival. IO The really gotten approved of general response on to IO inhibitors fairly that learned PD-X doing other and trials be with rates, of

we meaningful efficacy, criteria the wrote earlier the analysis for of thorough because control registration ultimate target enrollments overall response survival be past that have trial from proof-of-concept these us interim data to reduction, or better that's our to which rates. includes of who improve disease of we overall to trial. measures on a we rate, rate, suggests evaluation other the defined many goal response. may our when actually So duration treatment a at include than is lesion the patients including disease trial, trials the clinically important really predictors EMERGE And response stable demonstrate the And of look percentage endpoints and continuing of that's as IO effect based survival, since

the in predict try out, best survival to X. So to Phase a benefit figure what's to way we need

And expand, profile And also then rate. to and so in looking safety be things to we to see in those in obviously the well-defined response favorable addition, are at a population. addition order need patient we'll a

think, we're really the at hope underscores what I you context really include we're patient measures think in last XX on of So for fact at that I efficacy weeks the of enrolled, the the duration are that which follow-up. critical data. understand of for waiting least that that looking those we immunotherapy sort And helps, right because

drugs reasons out, and really the play best the of we of do the that their that's need So analysis so let effects one the to can results. time there's, we that

important and given Just has trading, for how where to for efforts or your stock Kim, where right some follow-up maybe does monotherapy anti-PD-X cash pretty which data? on currently now the the your is interesting become position BD is macrophage your program

Debjit. Thanks,

of address us So wholly-owned how complete things obviously, the of sheet flexibility I strength try that think one a And strong balance our we we maintain sheet. balance our keeping gives in pipeline. always to the is

way raising be one the continue as I in sheet. we bolster to balance looking ourselves. certainly you time we are we'll at some COVID. a said, we'll markets when assets balance is the flexibility partner well So we're said, programs the have always as But we right looking opportunistically keeping as to as maintaining forward continuing strong towards or of and BD between money other lot I versus have exciting But feel BD and to believe, our opportunities, like despite very be even to to

we into of on lot having on I owned that, look the four clinical I that really that Debjit, us to as and gives front. stage XXXX, think, Yes, flexibility jump pipeline of a assets, also entirety our having think just in think we

does Thank program. you. time. gentlemen, Ladies I'm you questions showing queue thank the participating today's this the for at and in in no conclude additional conference. This

wonderful day. disconnect. now a may You Have