NKTR - Earnings call transcript Q1 2019

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Operator

Good day, ladies and gentlemen, and welcome to the Nektar Therapeutics First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Ms. Investor of Head Ruddock, Relations. Jennifer begin. Ma'am, you may

Jennifer Ruddock

we Robin. available call developments Howard and no nektar.com. now turn Investor these filed forward-looking risks that obligation the We at business. future are Officer; webcast our I future thank Thank in and clinical XXXX Chief undertake future XX-Q Officer. us result our over joining President Howard. clinical Dr. future, otherwise. of and and clinical to predict, certain CEO; will Chief Jonathan regarding Forward-Looking and therapeutic call, as business, or to those and our of Chief Nektar's Important our On other will candidates subject trial our Howard Dr. you, the difficult which Good afternoon, and timing which Mary on Financial at of X, make well to our we Labrucherie, regarding potential risks Officer drug and the President information, update uncertainties at Crystal. statements including Zalevsky, many you are available any our forth results; XXXX of Gil Steven new control. trials today. certain statements Statements the partners; Because that R&D; development Medical A www.sec.gov. be to expect of plans uncertainties our outside inherent Doberstein, of are on the Head of clinical this these to that, trials; to for Robin, a statements everyone, Dr. Scientific relate With of whether the and our are including financial plans, our March and us set our to for are the and Form Tagliaferri, as Relations they start CEO, drugs is future of the as guidance With website today's of page call

Howard Robin

the the you you, planned other for continued On Jennifer, thank additional including Thank bempeg, with call, today's bempeg and milestones for on will our coming collaborators. to for we program over months trials the trial starts joining call registrational the today. us everyone review

study for partner NKTR-XXX, advancement and our NKTR-XXX initiated is New And next being the our agonist candidate. Lilly. with IL-XX of IO program

page pain country. presentation We and continues the data NKTR-XXX. reiterate crises will XXXX. provide our financial update opioid front on for clinical plan guidance chronic in also year on and guidance The our news Starting first throughout an be to with

end, to continue crisis to don't pain a necessary addressing and and carry this that important helping mechanisms opioid pain. opioid can new that crisis new we to same on suffering therapy confident block the significant be patients remain existing We block as the believe to And an that market. in building chronic addressing building is profiles NKTR-XXX opioid the from potentially the medications back the providing low

but remain FDA as NDA August our has an informed review been a confident general NDA, to throughout set. entire closely work submission package that, they have and the We is August its the been committee timeline advisory and plan meeting to has hold our suggested has firm us of date no FDA with the PDUFA development to in we NKTR-XXX, supporting continue of review We done XXth. during the the data

weeks. stated company to to I we expect NKTR-XXX, separate next management several within team a we company the new have subsidiary established members the quarter, launch As last announce and

preparation done launch. launch our a potential to and is inventory team structure to and We a to completing objective one capital launch the to as had finalize for market capital prepare be launch, arrangements. production we with To approval, small a partners with distribution the we a commercial medical access force. or potential of efficiently As specialized are liaison more well support sales believe as

NKTR-XXX. continue the for about future excited be to very We

Moving now to immuno-oncology.

with our fight on a cancer. relapse chemo registrational cell and we immune enrolling Squibb, The line with system development restore harness DNS expansion new of of and key arm to added lung therapy. execute trials develop the for focused combination following joint Bristol line melanoma, PIVOT Starting non-small a second as immune bempeg, gastric in wave plan and surveillance and to to for bempeg with body's order types. the cycle with currently in in a initiated collaboration and continue includes in the designs and number next strategy are to first of full bladder medicines to our We metastatic components have pipeline and the Nektar on carcinoma colorectal in many that new registrational we address on tumor doublet breast, well and of sarcoma. line checkpoint properly Bristol-Myers as the cancer potential immune cancers trials first patients, trials treatment renal working lung, across the cell multiple cancer nivo

collaboration. in registrational across Our trial that landscape. tumor two and types together and a closely strategy been designs very teams we one the triplet various of are bempeg competitively nivo the as and positions competitive in as and that of changing developing working bempeg well doublet our on have ipi nivo a comprehensive

targeting development for early from INDs we of were our the in studies June As plan. you the submission our for the know collaboration start of joint

in by agreed the Given months Nektar the has been registrational and program date yet extend program trials complexity that four for have target not joint scope development to the the of started.

specific other PIVOT next months. planning to the Bristol the various are and year, earlier tumor Nektar As XX present at data we data the conferences. meetings medical over including additional stated and in mature from tumor types cohorts the

Now let me plans start with year. for ASCO this our

have this Dr. first additional Michael data Euro We translational will June Center several Cancer be for Xst of from presentations meeting on Horowitz accepted the Saturday presenting PIVOT.

follow-up the Dr. first month [Citi] Diab on include melanoma months line in the ongoing from will study. of presentation combination median the XXXX X.X that benefit deepening the from nivo (Ph) during the in of cohort continued had follow-up time the in of follow-up illustrate which update be plan bempeg abstract, presentation provide we not to PIVOT Although this presentation that cohort order at to a XX cohort. overtime. a for further responses in and This patients to an the will This

follow-up Now PFS. data are at month calculate the XX still time medium median early the too to

Cancer progressing activity, in enrolled exploratory Sandra sarcoma Second, showing on an study Monday in rare line Deangelo and observed of subtypes conducted Catering be Dr. Memorial from an and presentation investigator June Xrd nivo with bempeg oral there will by patients rapidly late preliminary Center. sponsored Sloan

breast last also currently presentations year’s lung ESMO Nektar including several we data are Symposium triple the Quadruplet meeting in cancer at are in targeting in cohorts for data from XXth CRI of data International meeting. cancer specific presentation and November. stated for also September BMS As Kidney the the targeting submit planning to quarter, are Cancer RCC we currently XXXX, this at negative and we

with study from initiate and study QX. bempeg currently and the and study will and Pfizer PIVOT combinations [indiscernible] bempeg this nivo Pfizer X of cancer For doublet agent plan bempeg, in and and and triplet Xb castration-resistant plans triplet Pfizer’s Astellas of neck cancer. prostate anti-androgen evaluate Pfizer the the and PARP anti-PD-LX The agent. Nektar had two of avelumab. cohorts to various in to doublet Pfizer RCC are and we Phase data inhibitor middle and nivo a finalizing the present and ipi.

are very patients because these negative the and solid excited PD-LX tumors. for work bempeg of Pfizer in to this tumor We with with Operator on setting two particularly

in with preclinical liquid Takeda that ongoing a an have with together TAK-XXX a SYKL to study three and We also our tumors. FLT showed Takeda’s know is which We FLT combine in model. SYK the effect inhibitor mechanisms bempeg dramatic IL-X dual

the patients. So, started is which in study, first excited NHL about always are we advanced

also strongly activation to could for NKTR-XXX expansion, of on applications where as We in to mechanism both Moving pathway know and promotes solid natural cells. ADCC and enabling anti-bodies, activation agonist tumors has this addition is enhance daratumumab. liquid greatly survival in that our in NKTR-XXX killer creating of IL-XX the the memory such cytokine IL-XX IND studies. updates T-cells which currently the

are the tumor in both currently settings. solid enabling first year, clinical our we NKTR-XXX targeting half designing of work the this IND We liquid and for trials second completion of and in are

nicely. preclinical NKTR-XXX year the explore move is great in entered Congress, a trial being the with in area NKTR-XXX programs. held their developed proceeding Gilead we would June CAR-T planning, on preclinical on studies have CAR-T. address evaluating this I primate Fred is the Hutch a Cancer CDXX In the like to into Association, urology. Lilly CAR-T started making with the enhance of progress Hematology Eli use our our with stimulator year, of and the preclinical NKTR-XXX one Hutch to on candidate autoimmune of and models cells combination with collaboration advancement European partner the development also last of data, clinical to collaboration Based T-Reg in of molecules this as Center we're discuss to the to Fred cell fourth research planning earlier our to Gilead responses various presentation These following We in first are Amsterdam. non-human and quarter preclinical the overall with conditions. we persistence portfolio the at different program NKTR-XXX of a data improve XXth also XXth

through study year. patients the have phase that escalation this later multiple that we and expect complete study in dose dose proceeding know, you As Xb an is nicely Phase ongoing ascending lupus we will

unable this data end Congress first and EUR. completion dose is from lupus and The to XXth also single the The presentation from study data study, XXth will oral we start the on include in Genetics, European will the study pleased a designing Phase attend be year. and XXth was will which X at completed Investor June from are of oral will currently NKTR-XXX of presentation volunteers the June an our presentation in for our healthy human to ascending session. in our to host that Xb held review those epigenetics at following Rheumatology to of Call study Phase We the of be immunity Lilly accepted data presentation Xa very the Phase Madrid.

this therapeutic financials. disease. treatment addition, excited Gil to as autoimmune two Xb for is turn about the studies NKTR-XXX, new review very resolution And indications also remain emerging of our autoimmune in start I'll in that, Phase half a of In over We the potential call year. two Lilly the second in of with a will designing that additional

Gil Labrucherie

to expense included to and program. development bempeg primarily as of R&D for Howard XXXX start review to with quarter first in Thank I commercialization expense supply XXXX, and $XX bempeg, for XXXX compared results investments. to quarter, first the expense afternoon, and the was million RCC, the $XX quarter of XXXX expense. for the compensation our to then of NKTR-XXX $X.X due The million with first expanded cash will a of XXXX the in future good bladder, cost and XXXX. million guidance. same of quarter the a is the in compared review $XXX.X result studies financial cell the Total NKTR-XXX. million G&A first $XX.X the NKTR-XXX, as and lung you R&D XXXX of We quarter non-cash entered clinical brief compared clinical of activities NKTR-XXX, compared and broad quarter highlights was XXXX. as non-small quarter manufacturing for increase development from of QX quarter I'll our billion bempeg of million of was G&A in first In melanoma, $XX.X stock quarter everyone. financial expense R&D revenue registrational first in in cancer readiness $XX.X the first of XXXX. to XXXX increased million increased expense

million We $X.XX a have a first of million XXXX loss per first recognized loss loss a or of quarter per loss as net XXXX. in of net compared the share $XX.X for $X.XX or the share $XXX.X of quarter to

$XX last XXXX. $X.X ending Now with let’s BMS of of approximately from billion to approximately turn due is call. position, anticipate XXXX our million balance we with which to the end guidance, receivable $XX a to at Starting cash million financial unchanged XXXX from with continue our our

BMS expense limit annual annual reminder, cash a to for with R&D R&D commercialization that of expense, obligation annual prior our obligation As our limit the subject will a but our million of is R&D bempeg development cap is not cost $XXX spending will net GAAP of BMS’s accounted to our a and share annual bempeg. expense

remains guidance million $XXX revenue at and full-year in Our a $XXX XXXX. GAAP between million

to fairly a basis. expect continue be revenue We ratable to on quarterly

of $XXX range guidance million and compensation non-cash which million R&D $XX depreciation Our expense. is still GAAP also expense includes XXXX approximately we unchanged, and anticipate million expenses GAAP between $XXX will stock

quarters relatively a compared R&D expense of be to in we higher QX As we expect XXXX. number do the to complete other manufacturing batches in bempeg as QX, of

component our significant our bempeg the a expect BMS to as generally clinical be of XXXX we drug an supply collaboration, to expense As in shares of bempeg. supply support for manufacturing development our plan bempeg R&D investment and multiyear cost. Under manufacturing we build approximately XX% our

funding R&D broad development well and NKTR-XXX, IND is commercial in bempeg our clinical into is as supplies pipeline advancement approval. to still projected $XXX a inventory for expense $XXX the Beyond regulatory launch between NKTR-XXX G&A currently will NKTR-XXX capitalized in and R&D prior of investment of as XXXX, million. we In not are XXXX that complete included a million be expense including stage. NKTR-XXX, candidate research the a the future manufacturing to

necessary approval for commercial we to the NKTR-XXX NKTR-XXX for with open approval and invest are carefully activities potential our And regulatory of support that, readiness approach Operator. we as I'll later continue this investment call year. staging in in We a to questions.

Operator

Thank you. And Instructions] Cowen. our first Chris Shibutani comes form from question [Operator

Your open. line is

Chris Shibutani

is a Great. in programs. bempeg I requiring extension all relating there would get the this comment the of strategy that genesis very - Bristol relationship, what you issues and years of If an just beginning Can helpful. is that all terms only Are in particular is? the commitments believe indications. that to Thank much. I to trials update was to across the at commented the appreciate just and or of in any the you be I meet timeline, of there could that enrolling not different about you

think then Can across that you to first the that to should trying first, the line, or but can we line of one think Secondly, fire Thank finish of we the we also cetera, but remember so the how extent help incremental the approach if list different help that crossing with moments a of or the is about when et with about get be could get how appreciated, think sequencing to us all to truth speak. that were stages? started the what indications as first, you. readouts about of about I much through certain we the next think melanoma to finish kind you it? approaching us might to key

Howard Robin

very extension, regard complex month Chris. Thanks Sure. in four Look, to the programs. these are very,

we As with the preparing you five, We're six next already seven We're have INDs. INDs very field. six, know, working closely BMS.

is We trials. we into of amount have and lot a great relationship with It's them. landscape tremendous want And get a with must go to competitive these sure rapidly evolving are we these to and this of right. make that a thinking a studies work them successful

are aggressive And is forward this we an moving have to of definite a little on two the think perfectly extension a we in terms months any a I timelines, development the between we and think case, done. something companies in four think reasonable is initial this of get that such I focus plan. we complex but were maybe rapidly

in I'm going what go ahead. might Mary see readouts. you Mary to terms let take that Regarding of question.

Mary Tagliaferri

in bladder Yes. first you Thanks. Hi, or that four urothelial Chris. ongoing and of we're line we terms readouts, actively trials know incremental Yes, cancer our carcinoma have recruiting now registrational includes and study. metastatic as

melanoma Phase X line trial. first Our

have relapse actually with to refractory RCC patients relapse we first point plus TKI. PIVOT-XX readout lung trial bladder And for could patients study. Phase clinical of PIVOT-XX the these chemotherapy and who and RCC inhibitor terms cancer our would are melanoma expansion trials are fourth cohort X trial then we cohort We also treatment line is the bempeg check that be our X have expansion cancer and would a cohort third in trial The the comparing Phase second expect the versus fourth are readout, first. be of the sequence trial from we first-line where in Placebo

Chris Shibutani

Great.

I wanting steps as something Bristol’s or think sense Could don't is been of on wants speak? bladder regulatory that firstly go press would first and perhaps into bladder so a be mindset, indication that impressive to coming to an maybe meaning some cluster to has you there to your individual fire go. forward mindset data be terms filings give if then of and to there In there other with would proximate I in or multiple to readouts know with

Mary Tagliaferri

accelerated of FDA invasive the have possible it’s with X trial. Phase Yes as cancer an we muscle used is confirmatory this have for first we approval before that with bladder our and and trial to you that the about go muscle we being agreed we potential have upon conversations shared with which bladder also a shared FDA the had trial

first So be for it’s the possible filing that could the company.

Chris Shibutani

will you, back helpful. Great. into is that Thank the go I queue.

Operator

Thank you.

Choi next comes Our from from Goldman Sachs. question Paul

check open. Please question that on from from your mute. is Morgan. we on not And line line to Your is next JP move will Jessica Fye our

Your line is open.

Jessica Fye

Hey good thanks afternoon questions. for my taking guys

Just Chris’s first upon question. following few, just a

this. deadline if Bristol confirm what new studies missed to sorry can for Sorry was is prior the the PIVOTAL I ahead. - the you go the What under collaboration then the deadline and

Howard Robin

Hi Jessica.

You I’ll after that. finish and go

Jessica Fye

that the and data and at from have data we at update did since say mentioned any deepening been you did then of that further ASCO you will patients say ASCO has that just lastly abstract? also expect not to sarcoma the the okay. there Yes, abstract data in on should Citi confirm update sarcoma you responses melanoma IFP

Howard Robin

September, and was take running and the well that we so the first the have June next the question. by Okay, collaboration to four contract of that let have by we month trials me to first The thanks. of months. in all end moved moved agreement

I presentation September talk to talk did that the Mary be little recognizing that in complexity potentially also that case. we we date about a end where cover at said of a done work any new Mary. of I and I'm and to has the going did about and melanoma the it data is of the let will ahead So all ambitious responses deepening go ASCO bit as

Mary Tagliaferri

Yes.

submitted different responses So on who who abstracts and are patients some very Dr. out agents. breaking as who ASCO sarcoma presenting histology, sarcoma various XX advanced by over possible more will differentiated presentation cohorts multiple she Jess for XXXX included study it she Dr. refractory to these will were have accepted to Deangelo that The rare that and and to patients It you are sarcoma. multiple histology is know oral data be be on roughly Sandra moving were and an mild the her will based to sarcoma been and adding enrolled be abstracts. Deangelo chondro her that in patients was

Howard Robin

covered And you we bit. melanoma what the because also about talked a on some Mary discussions the that -

Mary Tagliaferri

we Yes. year we and deepening so provided XX% on will of remember will be responses in to follow-up an at Sure, CR had mentioned update of roughly update last an of months X.X a as remember at the by providing with Howard and terms of that melanoma that so a Jess responses that you ASCO. and at confirmed SIFI we you rate independent time XX% our had radiology we presentation at will

Jessica Fye

be melanoma? in patient abstract will And data for

Mary Tagliaferri

patient have data the No, abstract. we won’t in

Jessica Fye

close just mentioned could did to PDUFA be more a XXX you for Got say think i.e. the in it. and were Can I you one potential about the adcom date? Howard. August very In beginning timeframe when it ask you talking I

Howard Robin

to yet. you Yes. has a further comment have in day We to likely have don't us to an told FDA they that? August. like that adcom would Steve, on The want

Steven Doberstein

afterwards. and August but they a a adcom to Thanks pretty seem FDA particular in That when we Jess. this precedent fact, there date for are may rapid shooting that almost as little the has to to The date, Sure. potential for. close PDUFA with indicated scheduled in bit it after that tried turnaround is approval decision good division Yes. get is adcom

and think [Dsuvia] was most later. is weeks then For happened three there adcom approval I example recent example, of was can an (Ph) the about where

quickly can they division. So, this particular turnaround pretty in

PDUFA the in potential about So, of closeness particularly I’m the date. time to the concerned not adcom

Jessica Fye

Great. Thank you.

Operator

you. Thank

Farmer Market. Our next BMO Capital from from question comes George

Your line is open.

George Farmer

PFS seeing I Hi. not questions. or for say more you bit ASCO. we dig taking hit Did have to Thanks today? my data you into the will that want months the a as of at median on be as XX melanoma of that

Mary Tagliaferri

Yes. Hi.

our PFS. and a follow-up month from meeting month and are to-date cohort have median immature XX follow-up data will for So, presenting we be calculate to we XX too the this data a

George Farmer

Great. Okay. patients to as as how remaining are comment you treatment today? of And many can

Mary Tagliaferri

today, could treatment XXXX have of XX, as deepening did but responses had of have on Not patients a had that seven we as not that reached in CR. of

be now update we And will have progressed months patients how on able an these median to XX provide so follow-up. at

George Farmer

does XXX, could extended a also, have previous possible is close getting the I again? panel mean PDUFA. the And to tight Okay. be about back it to to it PDUFA question that so seem little

Steven Doberstein

Hi. This not the for correct formally is move Steve Doberstein. to From agency PDUFA. a regulatory the standpoint, it's actually

and possible like for date, their do it to them don't we really to However, they that is them to. miss PDUFA expected don't

George Farmer

Okay. very much. Great. Thanks

Operator

you. Thank

question comes from Hazlett Bert next Our BTIG. from

open. Your is line

Bert Hazlett

Yes, thanks.

Just there, And with your some regard had might collaboration? color comments from Have any to to regard be coming then following collaboration expect with that when we you and on XXX? Thank Takeda of up just XXX. scheduling data helpful. Any would you. interactions

Howard Robin

Yes.

kind scheduling we scheduling make hi, recommendations date. of to DEA decision process, who the we XXX, of until course to that discussion between So, respect the or makes wouldn't recommendation a during but expect to discussion happens after that and advance FDA, with for so happen post-approval, PDUFA

Jonathan Zalevsky

Bert. is trial stages. Takeda about response very to your underway In the got collaboration, just really and it's so This earliest in question J.Z. a Hey the

year the or to a patients. it at So, so take we expect may least enroll

probably would that data at next looking trial. a be we looking timeframe would that reasonable where year, is something from we is be So

Bert Hazlett

Good. Thank you.

Operator

Thank you.

from Our Yang Difei comes Securities. Mizuho next from question

line Your is open.

Difei Yang

questions. and taking my afternoon for good Hi thanks

a Just couple.

time, then four BMS between perhaps is force four delay they the sales more expecting The months readout to launch secondarily first you any data time that delay on that the in there months need the one think with inform is delay NKTR-XXX collaboration, a burn the is it that how just help IND need and to decision? to maybe potential And will regards are potential NKTR-XXX? you or prepare tactical for did to about more you that

Howard Robin

Okay great questions.

think are that I it are no readout waiting sure is we done we data is sure to there extremely study. latter everything for, purely - and we work manage no, question, right making design and in that competitive the our we has and that how get making that the get and how we

is So the there no data looked here. for being

opioid really a first I on hopefully NKTR-XXX that is chronic it have less your abusable unique pain Regarding the a helps in think market to lower this patients from and question making put and are we who a a benefit opioid. is IT way back molecule, goal it forward

sales this for I organization. into equity don’t fairly this, have I it’s I marketing small a capital created think expect a we think we think are subsidiary and to partners that seeking concept. is coming have fund the we mass

that here looking high fairly opioid, doing way organization. sales are small probably XX and science years a very will behind maybe a not is it This new scientific is I very we average very first in your molecule a what think in launched NKTR-XXX. This a different be scientifically small opioid is molecules, the for liaison. very, expect focused with medically story it’s I a technical sales organization

Difei Yang

Do [indiscernible]. the operations NKTR-XXX. off and will for this Just operation to expect think Nektar a on the you partnership follow-up or on the quick

Howard Robin

point owned At question. of a course not partnership, good subsidiary Well that. expect wholly it’s this it’s do in we a funding outside it’s a

to very it spun it’s and the that point well entity some do at a very be could that. at some think it I think well happen, up off set could time potentially

the how well drug Let’s does. see

I crisis. drug if solves that a this be then goes think the are day. reason no face successful to an way in least some that this we one there, of And long the at is there we or itself believe on can’t opioid entity to currently to problems solving

Difei Yang

questions. my taking for Thanks Okay.

Operator

you. Thank

from Van Jaffray. Tyler Our Piper next question Buren comes from

Your line is open.

Tyler Van Buren

guys updates. good a the looking follow-ups to Hey had data of year. with rest clinical a of of presentation. afternoon lot forward is There ASCO respect the to I the couple

is is think I months mono-therapy understanding survival that correctly. if my free So progression X.X with I median recall nivo

its so rates, And early it’s if follow-up, obviously calculated see control disease months could comp alone but well and too to appropriate secondarily XX tracking remind PFS also of you median to ahead PFS that if to that is of isn’t did be that with nivo, of disclosure going median for response be ipi rates suggest meaningful what therapy? it’s important and combination and

Mary Tagliaferri

that great too the data the with to plus PFS significant are median pleased for difference nivo that definitely PFS. is fact Tyler which and XX question a we Thanks as Yes. the very even ipi And immature still know wise calculate with less in you showed was PFS. than statistically as months a median

seven double had CR the Likewise, higher follow-up rate nivo XX% just also a to month almost more than median compared ipi alone. to at plus CR even rate, its we at published. and with already compared been that our So, nivo much

AEs, data data. having when patients agreed a last XAE a events. year, comment to I treatment survival at XAEs rate year with four dropout presented So, the the is XX% high grade Citi and few look the about one when less than is will at this we adverse There XX% to almost had make rate you patients and we grow who with any have of

independent which objective been trial. good So, all by course be high response CR this [indiscernible] rate in rate, patients and able our rate, Phase disease the radiology X totality data, to will the control tolerate very high treatment, of

are We very pleased moving into study. registrational pivotal

question. So, thanks for the

Tyler Van Buren

color. is That Great. helpful very

the have it's limited you there patients can response whatever what in clearly at options, with throw I low. population? But on help question last difficult a available would expect if one and Just especially indication refractory sarcoma, on expectations is patients these patients is you set bar to this relatively in you rate got imagine

Mary Tagliaferri

a Yes. great It's question Tyler.

but You she agent. that Sloan of is, centers Deangelo of an know also on largest sarcoma only is part with IO the an is one the nice not expert the at expert sarcoma treatment Catering sarcoma, focuses this in Dr. cancer is on Memorial Sandra

plus So presentation sarcoma single treatment agent during put ipi her into perspective published of and both on the nivo with the she intends and and to that at color ASCO. at nivo podium

Tyler Van Buren

Okay, understood. questions. Thanks for taking the

Operator

Thank Hsieh from from comes William question And our Blair. you. next Andy

open. is line Your

Andy Hsieh

Thanks my taking Great. for questions.

big is The Tyler's to median? XX very that allows question months you you obviously how is to follow Could intriguing. population remind follow-up Just currently that earlier. a calculate is me the that

Mary Tagliaferri

to Andy that you there more Well and is patients I at certainly color our will provide we just XX will said at seeing presentation. look total We forward cohort ASCO.

Andy Hsieh

Okay. your the modalities RCC is different is terms that know market with PFS you a thoughts And perspective being field, sufficient now? commercial just on of curious evolving approved, alone a perspective positioning from in obviously rapidly from

Mary Tagliaferri

Yes.

our that So, study survival the set RCC months X we Phase first endpoint. readout primary to we to reach have XX the have that overall us will guidance give and to designed take about

be RCC we survival So in on will an endpoint. X our results Phase trial study filing first overall

Andy Hsieh

any to Okay just trials the or just just liability understand that to terms help there that pushed me deadline Bristol one both the and goal back it’s of the to understand a I deadline, or of is is get last sort all is parties super helpful started. in from want if again one

about function of kind deadline is? of curious Just that the

Howard Robin

if trial at another in checkpoint indication another - clinical is has that that the right the missed, or just particular line on deadline basically Nektar that company. Yes to inhibitor is work deadline the with being any that

other with deadline the with inhibitors not So consequence of is could the missed. if is means nivo the work That the and deadline. of missing checkpoint it we that one

a wanted said complex right. I we these like sure are get make think it complex studies, to is we I this and landscape

I wouldn’t read months, extended more four into the it than I that. we deadline think much So

Andy Hsieh

for thanks my Great taking questions.

Operator

Thank you.

from comes question Sachs. from Goldman Paul next Choi Our

Your line is open.

Paul Choi

programs? CAR-T thinking in data is early would or have are hurdle about the programs of you to want we potentially from versus and good seeing the you you to terms what of CDXX with for thank stage terms the regard in clarify questions. XXX either early JZ or our I maybe to you thanks afternoon us Hi of some some Mary rate the biospecific what can taking and program Maybe early guess program the see antibody of

Jonathan Zalevsky

is Yes, Paul hey this JZ.

at of preclinical the that of data one this So using effects improve the can be where summer of organism. like the we is conducted NKTR-XXX they of the of then cells when that their see ranging Hutchinson categories example human and the we to CDXX for they cells, Center preclinical activity is are to Cancer will from inside we CAR-T. would so the to And presentation collaborators to kinds use have to Fred improve early that showing things go coming ways the that studies sort our of any can long happen differentiation minimize persistence the that CAR-T

more preclinical maintain use patients. even NKTR-XXX that kind Of course ultimately it mechanism you right to things mice, but cells survival. is we the dealing And homeostasis long-term then are was than for in with using same IO-XX of the that and their also

natural actually biology, setting example kind say long So those of that time. so ADCC like compartment long, the looking would to achieve you the you are cell are cells space. a periods setting in maintaining different categories combination of activate we ADCC the the biospecific then killer like for to considering when or are setting kind of an In those of there activity increase antibody, in looking going CAR-T of right of for a for

are having the So ADCC coming then chance synergies when that that have the kind of of best they of two the patients antibody together. mechanisms co-administered the

there use different So in different are goals settings. the

Paul Choi

guess about refractory you regards forward regard Okay or the steroid that disclosed great data I publicly experience those have how potentially thanks you or that XXX Is, new do will the to for going think that with to two steroid indication. that the data that you Euler. the at have and in coming up, posted with been the Phase then or are in mentioned population terms and of segmenting population

Howard Robin

Yes.

So a presenting study ascending to from dose be a for question volunteers. is going the so in study we healthy single first are data this

set So our this is data is with a NKTR-XXX. that human first experience

and we ratio. to know segment, isn't to on population, on show of are overall going forth there data a there safety are data going to So so importantly, profile be you other profile T-CON pharmacokinetic setting. the steroid or selectivity not any its and the mobilizing targeting we XXX the on presenting of and of to components engaging kind of T-Cell effect to the T-cell effect specificity regulatory on Its T-REG T-REG that the compartment and pharmacodynamic

a that that second of we T-REG be clinical early then mechanism the very And action. field very to few expansion and to most molecules of very, and an there mechanism also one very of is because So action show data and kind stage agents are that has are targeting NKTR-XXX we question. is your excited such excited of just this right will and T-REG advanced up the this there have

are very with we excited, so we yes the program initiating Phase are be Xb and we this clinical year trials. So will additional Lilly Eli expanding

the in additional lupus are Phase Now that different disease two two and in we already Xb we indications. studies mentioned autoimmune running have these

will Xb we begin program, X and ends in be that the we the move that happening as will expanding studies all lupus. So really Phase after is Phase into the

Paul Choi

Great. let jump Thanks and will others the that. go. I for in queue

Operator

you. Thank

comes David question from next Our Steinberg Jefferies. from

open. Your line is

David Steinberg

extent to Thanks. successive severe abusable I that a that all among less loop from There couple train more envision force. to you sales the deterrent to so [indiscernible] it that have drugs thoughts secondly is generic the with you and questions. the market approval. when road company leverage is being the there that the Thanks. or of and at is the to so some abuse involved that a sell top brought the other And the renew with of new any or with with Do opiods down a Do non-ADS you then approval view it one back products KOLs products in a want NKTR-XXX, some NKTR-XXX point or to assuming product could not have on going likelihood each to happen. might. if be pain will JV thought and Nektar

Howard Robin

difficult it's data that abusable well can't as might is the I point very difficult a in market Look that readily FDA that. the analgesic be the to what as future but NKTR-XXX happen hopefully comment it a the hopefully future certainly a a of and do satisfied obviously form may potent converted with opioid more opioid about over in less time demonstrates to like what drug with develops Sure. into market, and some will that predict think be with it's product NKTR-XXX, abusable that at is

part second your The of was? question

David Steinberg

will can force what one with this company NKTR-XXX? they or that you the product be in a are It's, involved bring you sales just additional do leverage products know along to extent to you the think

Howard Robin

I always to the whatever look very to at subsidiary of at like take remember Obviously management exploring a question. those synergies have have effective investors. and subsidiary do the efficient this in you, we products Okay with that thank we David something other at possibilities. return and we potentially highly, the we drug cost that cost NKTR-XXX point possible to to subsidiary market that are there I would certainly be that a carefully. good that team that is has And is new and expect and and the created new Look It that right. NKTR-XXX. would entirely be could Nektar look highly are good

expect of I would consider say sense. them if wouldn’t and to that while focus makes the certainly its So something is that I it subsidiary that immediate

Operator

you. Thank

from from Our Canaccord. next question Arlinda comes Lee

Your line is open.

Arlinda Lee

presentation pretty effect negative about what conversion later information I to data data for might earlier was coming are you the on if Secondly, broader might taking Yes picture guys scope cancer have was about the that questions. I look comp that intrigued year. any triple like? in we Hey PD-LX wondering thanks and are would a data of set I set breast be this? additional that my this out patient highlighted our of that see curious

Jonathan Zalevsky

JZ. Hey Arlinda this is

Let me answer the first question.

is we accumulating so will poster going summary to line all both we data PD-LX are we so the on at the those base present the that been translational that more ASCO, we be so of have of and have and highlighting the that first today at PD-LX among conversion So presenting seen as information we will levels effect well far. be

will and our provided as be adding always of ASCO presentation that that that we we those so in appropriate and components updates. action in mechanism would data then for are be And future summarize this will translational tumor of specific doing those presentations year, to-date

Mary Tagliaferri

checkpoint triple breast to population Yes Paris, triple X%. data negative this International in you in meet like I negative end patient us Fifth where Conference we this cohort. will of you do inhibitor very the data Quadruple on the to breast low cancer. and its cancer be September because Immunotherapy the is presenting agent Remember the could single if the for Arlinda, is you Mary on benchmark for hope travel

contextualize the line first inhibitors the data it able to will population. We agent and in the checkpoint to data show relationship be in second and in single

Arlinda Lee

Great. Thanks very much.

Operator

Thank you.

Intelligence. Asthika comes question next Our from from Goonewardene Bloomberg

Your now line open. is

Asthika Goonewardene

on XX% data Hi PIVOT where update been third are already, melanoma, guys thanks you for XX% the data, taking will the were et I And question is the on the said PD-LX other it’s if going but Thank melanoma the we but stated, want that line follow-up year? just on that Arlinda’s you from on just us as be pre-closed translational this had PD-LX you. I you my cetera. the some such conversion can Howard those on the for patient second, questions. of then as trends or presented of groups about give to other types Previously today tumor when and arms an we RCC, recruited, wonder this see to could have for to will focus asked maybe poster some well? those that therapy it

Mary Tagliaferri

one question I JZ. Yes, the I punt so the second and to take will first will

on with these presentation, we state all present we are as stated be You presenting three cohorts working data this record to and to meetings. when for have will Bristol of his gone we on that in different year know data Howard at

I triple to cancer that at breast will RCC and provide responded the Quadruple we Arlinda when at the the XXth Cancer the to continue second very International update meeting ESMO, Symposium with the negative lung will on just data an And we to where at present those Bristol I and We let JZ, Kidney closely data work you will present and answer question. will data.

Jonathan Zalevsky

quickly. very Mary, you and yes thank just Yes,

extending later types that in we the covering be will that will we focusing additional we appropriate translational then as melanoma elements on mentioned including we including ASCO at year bladder be this be and on will data the but So tumor presentations. PD-LX and those the as as data earlier, translational focusing earlier, presented are I and data,

Operator

you. Thank

question next Daina comes from SVB Our from Graybosch Leerink.

line open. Your is

Daina Graybosch

for Hi, going ones, A competitive changing delay question. the the those mentioned designs. couple with thank you you and deadline the BMS landscape back to

wonder in no. asked a particular the any through are more I previously you you dynamics working waiting you color are said and if somebody designs? you trial particular think those that competitive readout give you if question on I for could

Howard Robin

a it's to but some flavor good Mary overly ask me give for specific, let step question. in and being you look, wasn't I Yes, that.

Mary Tagliaferri

Yes.

and what approach know April You not Dan to expanded and at well. cell about happening lung, non-small it our we know lung to cancer cell population the gives us you are pause are X% we is a XX% now as patients as was following a you is strategy pembrolizumab label to certainly just have talk than that first-line non-small only for going but that are first-line in to said lung And just this always cancer greater baseline, IO the we with example for that the sparing back I expanded chemo has closely to our the and just one in is that give XX% best example, to agent and and example. to in one single a can first board forward drawing several other probably people you partner in us landscape the line combination call on is path know talk chemo this positive PD-LX brought include about

Daina Graybosch

the question more deadline. on one it. Got

sarcoma these maybe enough indication some, forward other possible we it is if starting you Let's or we we ASCO that end see depending at in one, on it go let how there data potential based wasn’t most is. pick and particular and you don't on that would up registration hopefully with you trials. difficult checkpoints that Should collaborate in maybe company? that start and the of passed deadline Thinking just assume

Mary Tagliaferri

months short ever of period I is know, man hit we and XX time. thought think time broadest more development again, delay of have period short a a we to forward is and program all aspirational, and mention in and the benchmark move you few nivo provide very tell Yes, patient and to subtypes we forward Dr. a we she what IND studies this those extra of we file realized to design desire and calls in if XX would have factor the you to sarcoma is to her need put in. frame for will these a I going a able timeframe rare going of month that clinical want good you known be first we on were this Deangelo the to XX get reference really with too for to that about can doesn’t a she nivo, survival. therapies frequently me I in registrational really this that prolong patient population data trials

Daina Graybosch

it One differentiated with of Could great. question. differentiate is exciting how is development? your clinic is some of asset you you lot is in teams remind moving That permutations forward, and pretty it field preclinic. us a last your IL-XX will the ISS competitive how in or It’s the that

Howard Robin

maintain expresses expresses are it other so can contact. most case in so the was IL-XX the cell trans-presentation. to particular a gamma immunoacid multiple of And those that this have actually of trans-presentation a cell, all signaling the reproduce different in and risk down competing introduce which beta functions is they maintain mutations means completely critical mutations at are so And different not that forms, pipeline also than of that all things cell those we and the one receptors which what that well is here did carry sub subunits can class. this NKTR-XXX bound receptor number that such which competing receptor are this Daina of with question and anti-drug we of a with trans-presentation ability molecules limit NKTR-XXX due molecule the of IL-XX importantly, IL-XX some made they cell molecule any biological form. all neighboring felt as was that important fashion use also complex great the what subunits only receptor sure to that IL-X we Alfa and completely large the to create lot to the IL-XX biological the they in in two IL-XX cytokine cell soluble And engages diametric can Nektar can’t and receptors functions receptor the which really long-term to including receptor the as of a and clinic, of Yes an a antibodies. the the signal signaling. and in of soluble to our act into of one we call When of all in to molecule as for contact is of it IL-XX and interact IL-XX

into very non-human able differentiated preclinical been to what dose any IL-XX to our in demonstrate This those there activity biological effect molecules primate primates go our companies lead NKTR-XXX repeat that administration see So loss of excited administration. kind don’t effect how that each or show and are prophylaxis important, on some that of of of repeat is administration limiting clinic of overtime. maintained from non-human We tacky are some can biological loss a We something the with into have from NKTR-XXX is because very of see biological any with a clinical study. out of is because in there features key other the studies don’t or is data cycle. we that a repeated in competition we very, then administration

excited really looking to have us we number soon. points very forward very of make are a So and we that program into clinic very, it differentiation getting the that of about

Operator

hand Thank for Thank our will back call you conference for concludes any it Howard and Robin you. to remarks. That today. I closing

Howard Robin

very immunology thank and what all best our I'm industry of joining spectacular done. you they to what have the us for a is usual and employees in I pipelines think proud doing Nektar want with thank as evening forward this moving for of the I everyone Well job of immuno-oncology and one and

and you Thanks. will ASCO. we at you thank So see

Operator

in does gentlemen today’s conference. you you for all a disconnect. This participating Everyone thank program and conclude may Ladies the day. have wonderful

Nektar Therapeutics (NKTR) 9 May 192019 Q1 Earnings call transcript