INFI - Earnings call transcript Q4 2021 | Infinity Pharmaceuticals, Inc.

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals Conference Call to discuss the company's Operations and Full Year 2021 Financial Results. My name is Crystal, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. There will be a question and answer session for follow. this being that request. at advised be conference recorded is Infinity's Please

I your go Kauffman. introduce like ahead. for Now to Jayne host would today's call, Please

Jayne Kauffman

Thank of our to year XXXX everyone. our you, and business full good company results to highlights. recent review call discuss Welcome and progress financial Crystal, and today's afternoon,

note for Larry remarks. Officer. me Robert Ilaria, and available press forward-looking with call during Perkins, We'll and financial the on today strategic our results expectations development website President; at our of about the are Adelene projections. therapeutic call, details infi.com. our Chief and and Chief Bloch, Medical Q&A make our Please Executive release our issued may the On and including is candidates, today clinical that Officer The open objectives, plans we call strategies future plans, and following this Chair; statements our potential Jr., product

may and forward-looking caution make of future information, the as our results number for section today, annual from you in may otherwise. the Risk today, Factors whether them update we on what views of result with that only represent statements Our of factors, materially new filings described in other the and These project considerations XX-K SEC. Form important the of report we differ we in actual a XXXX future, our not a to we due as events or including

the call to to Now turn I'd like over Adelene.

Adelene Perkins

and additional future Infinity to to a progress global create XXXX necessary XXXX are well in Thanks, challenging of against poised and data, these good geopolitical to and path team XXXX, we Even an joining a augmented Building now pillars X weather on and establish meaningful today and are eganelisib eganelisib with to storms. and tensions first the study, XXXX the clinical to tumor of and us eganelisib in continue balance the to review and Jayne, registration value you foundational strengthened accomplishments clinical patients in make deteriorating Infinity's sheet. shareholders. indications differentiated expand was fund value best key to leadership positioned great solid maximize initiate thank for during for all multiple markets, The to drug, everyone backdrop the place is a forward able capital pandemic, goals. evaluation

we'll drug review XXXX, own are impressive particularly turning of Before tumor in yet The cancer. translational has in The PD-LX the to date. their the this value enabling robust foundational or current whom in results health right, triple tumor distinct of checkpoint results increase are standards including types, the data as resistant encouraging XXXX. of head our tumors all have and more studies XXXX the next multiple these of MARIO-XXX XXXX in TNBC X study neck the cancer the care across in breast cancer, Antonio in call, max inhibitors with the been stages the immunosuppression patients the tumors I'll progression-free well San These as to patients alone compelling both on and survival the over clinical metastatic are and solid disclosed different the the and are survival frontline underscore optimize median Symposium from where mechanism focus immuno-oncology positive in X patient well to totality therapy metastatic of Cancer including XX which inhibitor the our or negative to and checkpoint microenvironment of UC by ineffective. today's TNBC; therapy. first-in-class and MARIO-X even to months. us data across that of pillars, X and as of eganelisib, included study. ovarian from XXXX, to median activate of light urothelial reprograms patient promise power for X from further with our data in UC; population attack We specifically effectiveness unique cancer metastatic benefit settings. Improvements generation of squamous overall second-line inhibitors eganelisib's These limited in against metastatic ASCO melanoma; drive underscored and combination consistent GU seen regimens benefits in settings patient of across immune data validate in presented On lines data checkpoint and cancer, multiple reduce more provided potential last as X negative presentations Breast SITC eganelisib combination

first-in-class Medical from having broad foundational enabled Schwartz. with Officer Brian our data, XXXX, Dr. another Ilaria, benefiting Robert and and In scientific and our us member, a leadership Dr. pillar, team. our Dr. the to Board of In addition being has by strengthen Chief driven Chief already expanded good are potential Jr;, the to former we drug now eganelisib and Stéphane our Scientific experience our Officer, Medical Peluso; and momentum Chief clinical Officer,

initiate sheet, but served addition eganelisib to million Chief Board, in supports now to development commercial we for I of the of at $XX year. Acceleron turn President late encouraged the which call Infinity's potential Officer Merck last this our I'll addition, recently Sujay its to strengthened a Rob? path. announce global as very that our bright. we very face and of volatility, initiating And of Commercial of this required last that In am Executive beginning and this review registration even our balance our to Chief future will at this of in was we Board Vice acquisition the Kango first today, providing year. raised the not million by most of Sujay With and year we're Commercial of $XX have Rob trial strategic we MARIO-P and the least, as expand as through in TNBC well important is timely insights year. XXXX, study pleased and first Directors. member prior Infinity's our Sujay over having resources Officer. bright our are market previously be in to is the as over XXXX, the very year quarter development study our studies eganelisib as to the our on data Altogether, metastatic future balance uncertainty future initiate registration the last for sheet frontline

Robert Ilaria

time, this with the laying Thanks, the Infinity be registration-enabling the of Adelene. exciting of execution and I'm of thrilled and the design part for MARIO-P. of to first eganelisib study development foundation at stage next guiding

survival PD-LX MARIO-XXX, follow-up atezolizumab, XXXX. multiple data Phase arm, including safety In to positive a checkpoint Tumor not to as the was months refractory Overall, Only immune XX% to compared enhance compared overall median safety cancer. tumors, or advanced molecule single-arm on strength eganelisib study therapy marketed X, to that a compared with consistent marketed improvement. to of a of PD-LX study. was ago, still efficacy encouraging treatment of nivolumab evaluable reflects harness with observed TNBC XX kinase negative survival combination patients why MARIO-X In in control the reported TNBC X triple-negative with system median from the X-year with PFS XX% These eganelisib our X.X of data XXXX. compared study IMPassionXXX, as the PD-LX for we PFS eganelisib arm. the led XX.X cutoff benchmark In we advanced half and findings immune plus benchmark and from the safety we the II from patient data provide MARIO-X arm. for XX reduction in across few a drug we of negative and median from to XX% at months advances, data the which reported data inhibitor the to indications a macrophages encouraged Symposium, activation. showed effectively I'm of highly with XX Tecentriq patients. the second January, the The Antonio combat in cancer. new to PD-LX X.XX, trial, was to have settings, XX combination control death of earlier relative the tumors, profile eganelisib October X.X population, both cancer the patients XX.X% negative Cancer a eganelisib small inhibitor population, and of positive and this San in consistency safety in the metastatic was with December and or positive patients, metastatic last probability patients with objective be data updated results tezelizumab nivolumab addition are majority overall tumors. patients We in to hazard at to in with our solid months represented negative strategic months of a remained the immuno-oncology randomized and gamma which the from median a platinum IMpassionXXX X.X approved study, attempt observing the the in potential XX nivolumab of out While important eganelisib, we was months do trial and the plan to more patient MARIO-X subgroups, Abraxane In in the tumor breast to specific the enthusiastic findings compared provided alive PD-LX to evidence and out the in that That's PD-LX a tumors of of transformative reported nab-paclitaxel negative provide months metastatic are of year the benchmark did immuno-oncology. lower The PD-LX eganelisib with to XX.X% patients naive immune the with The ratio treat presented and nab-paclitaxel Breast has reported of the PIX urothelial or data XX% compared consistent XXXX metastatic IMpassionXXX XX reprogram XX% XX about arm expectations a months with in landmark drugs X.X much so trial. show efficacy characterize microenvironment on improvement. and nivolumab to patients efficacy we we're work fully patients signals positive relative component any of received data observed

eganelisib the supportive TME of our patients, particularly study. a still alone mutually greater strong the as metastatic standard to receiving TNBC registration-enabling MARIO-XXX MARIO-X negative drug, unmet care. PD-LX a both Although the of need, the as date and we've modulating as in chemotherapy prioritize Due decision initial to potential made strong are as and we're

plan year OS and PFS receive frontline patients as double-blind by key end the that with Towards endpoints. a randomized this will MARIO-X, registration TNBC be will with care, which to for end, study metastatic study which All MARIO-X in triplet patients negative PD-LX we initiate standard PD-LX-positive the for chemotherapy, compared eganelisib checkpoint chemotherapy of chemotherapy and inhibitor alone and inhibitor and or patients. is either of of checkpoint a

Phase provide We updates our preparing design FDA year. meetings regulatory now meeting with for later our and of end study our will of II and authorities registration with for are to the this review global on progress the

in X, turn immune control compared we package, delivers with to for support nivolumab Our uniquely cancer presented one been clinical data had an tumor this Antonio encouraging mechanism opportunities to checkpoint immune combination joining blood my from data quickly activation particularly the Symposium to we At the immune encouraging areas by observed Phase a indications, mission, intended these of findings very are consistent or of to Cancer in tumor to call Phase PD-LX indications, paired review support clinical in past negative an Armed with in starting advanced we success. other strong baseline. expression rolling that that Breast this Infinity quarter in with in and arm. gene of tumors ratio, full will and nivolumab and year a initiate tumor And I'll basis in inhibitors showing eganelisib X December, have for showed its positive These bolstered analysis data Larry? of highest MARIO-XXX increase year. mostly enhanced PD-LX is MX identify benefit macro peripheral more of third both translational, called limited on MARIO-X, of patients had in II PD-LX in data reflective this action. San MX compared to of that, negative on Larry evaluate the biopsies III TM additional the the solid in of clinical treatment, increase PD-X in where activation eganelisib TAM expression what have eganelisib study to increase MARIO-P an and eganelisib indications over to financials. with in since program, the priorities solid In the the platform tumor

Larry Bloch

metastatic best expect $X.XX basic per basic $XX same $XX in And ranging to with and stock of increase financial XX, Net and development studies. common the the in eganelisib remains to of unique the million action you, as foundation as eganelisib compared this due any prepare of XXXX, of data business and was value has to to parallel, primarily ended financial in development December we due XXXX. for largest prioritize to year XXXX, in million potential development clinical first in for we or differentiated were and for XXXX, Thank to $XX.X ended XXXX in is an continue eganelisib's support we period foundational study shareholders. well and XXXX, in of compared an to for to eganelisib's services the the execute million increase primarily XX, $XX.X period net well and as the December across development loss year cash for continued million the on Infinity $X.XX to execution leverage XX, period execution related December per our year $XX excited In platform data expense increase equivalent million Infinity, the unchanged, of development continued $XX.X plans Rob. potential primarily been the XXXX. advancing equivalents of at expense. maximize eganelisib benefit administrative this continued UC, for share and or $XX.X metastatic of expenses early million the at $XX.X the for lay including where This for professional and end new first million and consulting aggressively additional initiation TNBC from to If multiple a the the in as $XX.X truly million, eganelisib's XXXX, expense as and year registration future the indications studies to our cash initiation evaluate diluted eganelisib. as loss for compared to and in This share was past This increase financing and not year tumor indications, and clinical to on an ongoing million. G&A focused well diluted an clinical loss XXXX, a million of hires net additional this strength for clinical for is are compared of expenses, other eganelisib as based development of its registrational million to cash and registrational and study study Infinity's year compensation eganelisib indications. compensation, activities. loss patients $XX.X our sale an year General and $XX.X patients. total solid In raised expense of advancement expenses enable guidance ended cash Research XX, development We're has eganelisib include for strategic a XXXX study. from tumor including increase our year-end for the range commencement path for XXXX securities solid will to program million of was during available December the XX, fund same And guidance consulting forward increase and XXXX. first $XX does is and in we eganelisib loss for same million to in on about Infinity having December common registrational eganelisib, $XX Infinity

we behalf your we up to you and of time, on Operator? coming look in support questions. So for progress months. the our you Infinity, forward continued thank can this call for the updating on open At

Operator

[Operator Instructions] question Rama Anupam And first our JPMorgan. from comes from

Your line open. is

Anupam Rama

made, sort about a development. potential as source which a talked on regional eganelisib you including you business or rights a capital? do maximizing to OUS the comment of about perspective? are that you from you any think the thinking Strategically, And guidance how of Larry, partnerships up follow how I just not want is nondilutive timing about

Larry Bloch

Anupam. thanks, So

perspective, certainly the slice dice tumors, a analyst because a global think broad look of and of So about certainly because from that feasible going potential eganelisib to But strategic way collaboration low it breadth indications. the that collaboration we buy across solid regional development forward. to we business in and indications geography we is feel high, terms of more the a than not you potential development clinical way path The to complexity at it. PD-X of swath probably of of that's can the we reach ultimately, advantageous is the be think PD-X the a ultimately,

Operator

Sandler. from Tenthoff comes question next from Our Ted Piper

Your open. line is

Ted Tenthoff

intended to So are meant like way. any be drug not sense MARIO-X? I way, what's like, don't that things going this what's going required X wrong taking of, MARIO-P but supply, what that, I'm long? and the take to not confrontational, what's Specifically, in really into preparing Obviously, but steps so a thinking launch to get are because studies? ranging for into those it's there? a be impertinent being

Adelene Perkins

Yes.

thanks, moving Bob. turn to of I'll for the it to these quite and preparation start, the for this then What's question. I'll over So is Ted, quickly, note important studies. launch And the is

lots exactly as exclusion, designing in operationalize population, analysis, and there's not whether describe are plan it, the what global soon regulatory be interim So and and patient premature trial yet just as while actively so has that the planning the all do position to we'll we're inclusion for it investigators the what of endpoints, until about of of It's lots it. it. authorities, finalized and the trial we've simply the and finalized And to from sharing to a is sites, as we and decisions all input is underway. design

along top rapidly as final design old And to come add? rapidly paddles of visible underwater. see doing analogy all you can Rob, the the not the what have may So the the if about It is. trial until the be going underwater. just things The describe that team I'd water, but is we anything

Robert Ilaria

Symposium when I was Breast long guess that we of And respects, engagement the wanted I presented will data, range. just is we data data wait follow-up. that. more really global then pieces planning really duration reacting briefing it, San to at thing writing, that's December. and quickly very take regulatory in I And ago, we a looking median and it Well, we certain not the the Cancer time, in what about mention Adelene our XX-month lot updated mature follow-up that in to one to things expand at guess, on of saying, you had think does Antonio that books, was and were moved And from like until

lot there's We that we for MARIO-P going track So want a platform we're types we do on do the do. identified going to only to say things tumor X the to on. recently We're that study.

So I think start, that's a too. good

seems and the So actually again, are things know for sometimes all us I planning steps. slow, quickly quite things are it but like moving

Ted Tenthoff

rather get it Great. Well, I'd right.

that. So I appreciate

Operator

from Kevin Our from next Oppenheimer. comes question DeGeeter

Your line is open.

Kevin DeGeeter

one tox. can deliveries tox with downward could different regard rates us that guess some think MARIO-P, the liver see of MARIO-XXX. having imagine to different you we I on did in help types, require I for adjustment liver or tumor about dose And dose a in basket risk protocol of guess potential study? mean, I

the about we dose? dosing study? Just of these think will same sort getting And for be should appropriate how patients all

Robert Ilaria

started up XX. of you dose Yes. to gone points. eganelisib at had MARIO-XXX I the good then think bring mean, mean, the X I some XX-milligram and daily had I we down

really I we're be Abraxane. something think a to dose triplet in milligrams dosing encouraged that and now a seems a with we're winning atezolizumab XX that's because regimen chemo,

being tend platform to I that about as So you think I different of think all toxicity think a across types. don't tumor study,

very a dose milligram I So solid think that. is for XX

bit? we're Now different the dose possible. able tumor that a day that do a across we triplet of But to I dose course, well agents. combinations the very It's milligram for study, to think we a we a fact will types can across XX and that and design lot different little bodes as decide of explore

Kevin DeGeeter

we And just we that potential sounds about then in into study move may before like think of of wondering how off study of as the opening registrational should MARIO-P? sites learning we and should Great. of I'm folks site XXXX? are resource-constrained world, TNBC. kick sort about It opening of gates how in kind in just a pace think kind

Robert Ilaria

are specific rolling is a excellence about a announced, going to the that focus focusing Sure. of opening type. things And Well, lot we of specific terms these types, basis. that study be by you on platform as one we that of see in a nice tumor can on tumor

of tumor so look do almost what cassette allows orderly kind module are the combinations a kind you're decide going type, in move it and of going at you nice and next can that And you then like it what fashion. X a do, open to to to

mentioned, think as we of envisioning you think basis. probably iterative way approach process. as tumor-centric you probably an I were it. take this go I doing in that a that we're most very you course, And the rolling do So on that is, of And of learn a how sort doing that's logical would

Operator

Roy question Research. comes from Soumit Jones Our next from

is line open. Your

Soumit Roy

it on progress. number data Congrats like see expect through would us in the what half from 'XX? second to we a cohort we help? Is should think really Could you're of the help expect RCC you patients MARIO-X from could

Adelene Perkins

Sure. can start, and I'll Rob then elaborate.

study that to study. study the combining a concept is is of VEGF with again, adding proof eganelisib XX-patient And was arm what single utility of and of eganelisib the purpose Tecentriq It really that Avastin. we're -- see So of inhibitor.

is Avastin not approved cell. in Tecentriq the and know, you As renal regimen

any regimen unlikely taking with concept, that proof that would it's be, of being forward. So

what go other with did So be great drugs that would the design and we be would would then and been to be. be we for oral we'd there's progress what want evaluating. right TKIs If looking at

very -- registration and So moving different MARIO-X be TNBC, were where different cells, of right drugs, the from renal can modalities this that is got the study. we out the of and we we've objective much directly to

Robert Ilaria

Yes.

us, mean, these one whereas was a really question multiple oral that of us, field is it with with that understand on has again, these kinases of big the RCC. to But VEGF. VEGF, lot I looking some be in give this course, TKIs. data -- antagonist, to of the to for combination a update -- For data molecule is drug getting And now as as modulating interesting with year. not was on like in of an Bevacizumab the to reviewing it and a clinical an checkpoint later inhibitor. And we're this we're moved

Soumit Roy

in here, and So going survival catalyst-wise data data, catalyst-wise? a that's MARIO-X, look TNBC essentially, like we and remains -- to second, XXX -- into the long-term goal main that are

Robert Ilaria

Yes, yes.

Operator

question B. next comes Our from Kalpit Riley Patel from Securities.

Your open. line is

Kalpit Patel

you also you would profile then PD-LX you be have MARIO-P know I which status maybe planning mechanistic for rolling eganelisib, tumor Based restrict that like initiating on you just focusing one biomarker One type based patients to underlying certain enrollment a type lung And where the basis. or with negative on cancer? any start applicable enroll prioritize likely tumor indications But are on for first? you're finalized of the will there on study. first? is

Robert Ilaria

Yes.

like X So I think tumor we types. all

admit, we anxious learn one all working we're I'm which will still But think start. are we have of so to discussing which I to through about still start one And I to them. like we'd with.

narrowing I that it's as as example, keep something, or in so to where the think quite PD-LX good. a needs certain prostate open would we restricting an cancer far particularly it for about not unmet subtype, clear mind indications be like

do sometimes. -- PD-LX people expression. approach of encouraging one the cancer, found things lung our But drug that is in with we across data the encouraged course, Of take we're

in I deciding don't narrow and to those, of that started. prioritize this but again, X -- of have it any of all We midst out anxious we're we're which year. the priority going to one thoughts we're get we'd coming gate. But think we like the So like to

Adelene Perkins

all, And And or only soon just Kalpit, but rank as know, as position a would not we those ready sentiments specific prioritization. and provide to as we is executing to. not have on does be But about details, -- we'll you we're in Rob on are yet that that. enthusiastic the to do share happy have he

Kalpit Patel

MARIO-X safety to results And triplet, understand have profile the on what MARIO-X? in one I'm Okay. patients IMpassionXXX? restrict type enroll time question the does would to on with realized seen that date any that should similar trying to line be the that if then MARIO-X in the you Based you study. tolerability sense, just we the of with

Robert Ilaria

I think safety overall, with we're very encouraged profile. the triplet

you usually sort you a have may triplet trade-off. Symposium Cancer Antonio in the pretty a is recall of gratifying discontinuation triplet, the Breast treatment there's the when for If San rate compared doublet because from which to similar the December, in IMpassionXXX, really actually is

oral the reason for hold if quickly Or very it out. it think that dose adjust. have washes for easy drug. we I a few So to days, is an It's you

have I would we see for particularly of like restrict autoimmune really anything don't would I sometimes diseases course, don't see expect again, because mix. I it So any per lists who anything of but se. patients things checkpoint restricted that, inhibitors and in are that limitations just unique the --

Operator

The next Mike from H.C. question Wainright. King comes from

is line open. Your

Mike King

hear you me Can okay?

Larry Bloch

great, Yes, coming Mike. through

Mike King

be, and what that how what are left pickup mean thought expense going is do until to have anybody how kind know a off, parameters to you the protocol reasonable for the be know can process? that wanted it's it long the needs discussions to conclusive has It to to -- Do that be what to any pick lock cetera you going the Anupam before size study? entire starters, to is you MARIO-X? down so be seems have for to were understand of able it, I et pragmatic to like from BD. not Just up with

Larry Bloch

the So we I We to as the time of of And case, global Phase a campaign. had I it's programs. collaboration took brought -- registration you global sort our AbbVie partner. requirement development for we study that, think a this In in place the of certainly to on started that's was approach we but a it's complete global the to heels don't one so, a for necessarily makes it do. III do certainly to easier of our last think, alignment the put in duvelisib.

and On to that. some have the actual FDA parameters lots some the input like loaded, and and alignment ex it's on flip U.S. side, partners have on and design once

relitigate You that that don't to reopen really again. want

sides. both that But we So the there's you're minuses track to plus this, and the the recommending. certainly, followed infinity last time

Mike King

that Okay. fair MARIO-X is secure start a partner the if to or a before you'll go, regional say But global ready to even do study? not is it either you

Larry Bloch

We -- we think engagement the Rob time the consistent line study going we're guidance our and is by that's with has of Yes. laid completely that terms with in be out authorities. end, year starting the to regulatory

Mike King

contemplated quick just And right. I are then All Okay. I apologize and clarification, types X from tumor missed the a what RLP?

Robert Ilaria

types The and cancer. tumor planned cell prostate sarcoma, or lung soft non-small tissue ovarian,

Mike King

You finally, not ask, deprioritizing just making that UC? very had cut? sounds like nice signal you the I are And Okay. there, a wanted it then to and is just once

Larry Bloch

guess I It's I -- TNBC. prioritizing -- mean, not we're we're

front immuno-oncology metastatic care But we it had opportunity parallel a glaring standard low those. is So of deprioritizes If especially registration in no development fact those to additional from very do for might I up. hard in urothelial it frontline to certainly X do In chemotherapy. we need resources, urothelial cancer the a we'd the up just capital of medical for the we at such the or global registration TNBC, to would to is whether at patients unmet as that studies the like guess, studies, pass just X implicitly, both from future to do cancer. There collaboration, bring of well, context business but patients care love we time. resource given can't potential markets that the your this was parallel

Mike King

Okay.

MARIO-P, say, making said words part I of, a want UC for put the in -- say So in that I your that Larry, guess a guess only is is randomized I a forward I you statement? course but logical you're fair guess registration-directed study to let's don't mouth, you versus saying

Larry Bloch

Yes.

data I think we've already got from randomized MARIO-XXX. controlled

seems registrational of Phase as pretty you II a on towards through cancer there's it indications MARIO-P. want going based we additional the MARIO-XXX urothelial of the study data the Rob clear would path sort be in analyzed. to And to for a additional opportunity, already explore that misuse forward said, data, back think like So we've

Mike King

Okay. Fair enough.

And sorry, if one in could I just sneak more.

Larry Bloch

Two.

Mike King

that? What's

Larry Bloch

Go ahead.

Mike King

I've Now forgotten.

Larry Bloch

successful. say would I

Mike King

to you back wrap before come me up. [Indiscernible]

Operator

[Operator from question our Karnauskas from Robyn Truist Instructions] And comes Securities. next

open. line is Your

Robyn Karnauskas

on Just questions. couple a a follow-up of

your about do not. typically more be FDA, doing are critical are of the is just to have the if the trial you about weighing terms FDA for surprising be partnership wants lately. with requirements thinking involved who it some mentioned when more want that you maybe something different involved in the requiring the derisking about someone you and the the that in just the that How people and when that So Help The your global waiting? versus to than they very sites? the auctions How to story needed, like big on a of the getting in at about maybe diversification off X because more people doing conservative, And lot it second, thinking thinking you're trials centers how centralized design, you're and thinking get past. specialized like at if you're locations understand diversifying us plate being mentioned? update clinical you versus

Larry Bloch

you Rob, BD I'd start the be to don't take question? question, happy clinical why the with diversification

Robert Ilaria

Okay. Sure.

the point a good bring the in I the and care. up pembrolizumab think of chemo is for States diversification, nowadays United standard you because

lot of sites versus excellence a necessarily. that the in is community centers going And so on of

enrollment. So in did we we be diversified I would way the think

I core would PD-LX we we be but to of plenty positive would excellence, practices of across want patients. other community-based able a want great think I do enrolling negative also job centers in of both really and think to a

Larry Bloch

tumor on as we front don't the toxicity -- the can touches hematological the also, gamma solid some malignancy about believe maybe that perspective, in in all authorities. as in the from And overlap Robin, far discussions to upon conservatism recently -- terms your And with our profile. at because PIXK about there's of in regulatory that front. sort We've of we tell, PIXK of delta seen the no point just

ODAC And correlation that in obviously, no accelerated the We're that OS to and see we're there we're safety expect -- immuno-oncology. to wouldn't at our very year a the also challenges, individual both or the approval. profile big approval data, So signals gratified from for we with a PFS new one which see triplet. really our has see our been signals even accelerated of between a the tolerability pleased, really said, of review Rob components. as and that seen we've We safety was happy the that last

diversify standard centers that centers. we think pursuing it's -- care But as will want Rob general we're a of So clean. well pretty path from sort perspective, a what is from of the said, excellence a community regulatory the versus we certainly to pretty of in

Robyn Karnauskas

a around have the... before follow-up to Just you the question get

Larry Bloch

PD.

Robyn Karnauskas

Yes, PD.

get stuff require to if more So they more resources, lot pharma a and expertise connections quickly because diversified trial, of have place. the a do more this with a in you does can want some all lot done really

So how the that trial were before -- feeds PD the as did versus start do you in of doing finding before this you trial the around partner? question sort it versus you

Larry Bloch

Yes.

don't we is we're to our So your in X as get obviously or the having FDA, parts. up for beforehand study to from the to of given there's our can't doing the you after profile find afterhand. that leveraging AbbVie be expect problem any some augment independently said, as of drug, with we fact. any place didn't a going BD take MARIO-X to resources path going critical the partner said, partner partner. the there's us independent a totally our alignment we've that the that with can I'd things year-end. bolt-on I own point. guidance is lined registration the alignment say the We But out before pursue would fact. the in That with in we thing with for get to resources there One AbbVie putting And with benefit, that by is

Robyn Karnauskas

another in. And one I'll put

over surprises be required required what any changed any surprises know you showed MARIO? you it's how you? head think primary surprised -- endpoint to a case for what I'm time. I would being you far Because FDA over think, in for there's required the Do would larger between what -- going have as what to options if the my box, PFS the in thinking of And as but that the correlation different So OS, what's show regarding just trials the just lifespan, you and to the primary call what's scenarios? endpoint how out kind and worst-case your that war playing what games can be best of is and you're I'm you're change. curious of the be

Robert Ilaria

very is Well, overall goal get clear to regulators any FDA want I has been inhibitor like checkpoint the of to as we'd our We have there. chemotherapy. we survival, to eganelisib been global want that that think move combinations gold is And with a that's -- new other standard. and

So strive improve with we don't think We that's for. I benchmark of that, a really a to way. I should cancer. think -- the in patients need is good I evolved survival that

think, good a Now PFS surrogate I that there's TNBC, get is, in so correlation been that very answer a example, the And OS. between and quickly? far, you can there for big question is

IMpassionXXX really at each mirrored other. study, the in OS look people have KEYNOTE-XXX benefits So and PFS

see at controversy I a So for least MARIO-X, of there. lot don't

so on I have would we like be conversation that if PFS, I goals But can must again, with we that in think encouraging deliver well. our are very far have regulators. you But thing MARIO-X a as on obviously win think overall survival. to

Operator

And have follow-up from King we do a Wainright. H.C. Mike from

open. is line Your

Larry Bloch

right, All Mike...

Mike King

of I'm I'm recent in the Nektar. sure MARO-X, your on -- studies, you've about you pressure just if so gone curious disappointment MARIO I. and the tested light were, the as thoughts back XXX in

at action. mechanism you positive. same had single-arm -- tumors that's a similar ratios, know a if had combo of I et had converted PD-LX CDX, data study, nivolumab, some look they their they biomarker in to effects, correlative many again, CDX negative to of Now with melanoma respect in They the study with they cetera. But different or PD-LX other

you studies that are that data make to belt exercise, just and And so feel and I -- signals you kind putting those kind sure a pointing go from suspenders right the you just the of reexamine in the actually as direct? of if back you wonder mean

Larry Bloch

think we their and let then add it first I for Rob thoughts. cracked

from able MARIO-X therapy immediate the clinical the progressed I from think of the would concordance of our and eganelisib studies the strongest our had with in in prior basis data were we melanoma that of a confidence patients back to all just the in on to the is just inhibitor including MARIO-XXX, checkpoint all presented where to and across high who but ARC-X both the responses get them regimen. correlated patients. survival exclusively actual the not back had not overall PD-LX MARIO-X study low as salvage objective low checkpoint-free in but and a PFS, we And obviously, disease PL-X data well with PL-X as way

cautionary state tail a single over our don't or a as because any the individual study. XXX example X database Nektar see would a study the patients single on single of not of And of across It's hat but we're definitely so biomarker off really extrapolating hang studies. sort we any off we not

Robert Ilaria

think in was at it it wasn't also, I but drug an pathway basic a important and signaling mean, new Well, of looking way, novel and sort a in delivering sense. target I Nektar a the

way to think look both very I to mostly kick always I a We've as looked critical fact tumors, thing. with we've MARIO-XXX, when it myeloid blood, cells. designed I important as does eye here, dealing the that. at things back small at against think molecule nivolumab been a a we specific of pathway what we do encouraged mean, in tires same and by inhibitor a in just it see that's do. we the and we in it's get controlled that it macrophage And with will we're really the peripheral

compelling do. actually it we what doing pretty only think have We drug the that, tumor peripheral too. I data, that that to in is we designed see And really both it's not So movement, matters. see clinical and blood

So it's important those things. of to I both think really

Larry Bloch

in like in We've also X combination as in also monotherapy, seen that our that we've a peripheral and Rob seen Nektar with, study said, biomarker seen inhibitor. we've we've the seen data part absent it checkpoint is biopsies both

independence compelling. the So I the single of think -- it's partner mechanism any so of reliance on it's the not or of lack synergistic that sort is

Operator

further like showing questions. any I'm turn closing Larry to back the no call remarks. At this I'd over to time, for

Larry Bloch

executing and XXXX, including team, evaluation to sheet and the expanding MARIO-P. closing, tumor really very analyst solid really with with leadership quality in of strengthened our focus means with be potential this life of improve today, balance on developing which fortunate in therapy eganelisib the we study feel cancer. we're And to for the first our well additional promising in of indications positioned people registrational length in Rob here bolster to with So and initiating

support. bring eganelisib much patients. committed night. very well to treatments I'd and we Good all in have look sites our roles investors that, interval realizing to in most played to the better remain So our you the Infinity these team patients the And investigators, to families to for our your and months, the our value for updates shareholders. thank as both in we who to and and their like of as coming regards patients of And providing trial as importantly, benefit advancing work our patients well forward thank as continued

Operator

Everyone, Thank your Thank you. participation have This today's concludes wonderful now disconnect. day. may conference call. you for a you and

Infinity Pharmaceuticals (INFIQ) 30 Mar 222021 Q4 Earnings call transcript