NKTR - Earnings call transcript Q4 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Nektar Therapeutics Q4 2018 Financial Results. [Operator Instructions] As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Ms. Jennifer Ruddock, Head of Investor Relations. Ma'am, you may begin.

Jennifer Ruddock

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

Howard Robin

call, the partner NKTR-XXX, and bempeg And with with bempegaldesleukin our agonist new program study Thank milestones review for you, thank of everyone collaborators, clinical as today's Lilly. being candidate. to trials next joining is our on program for continued registrational Jennifer, for bempeg. the the months On other today. plans The IL-XX with or known you us and including coming over call starts initiated NKTR-XXX the for the our and our additional IL trials we'll trial now start NKTR-XXX, first

for guidance We will our also provide XXXX. financial

from the gene dose are translational ASCO-SITC and the at meeting patients of San bempeg the NKTR-XXX know, presenting in XXXX tomorrow expression we As study REVEAL initial in Francisco. you plus escalation early data

Dr. Francisco, for at Adi investors PM Pacific to host on who with For we travel presentation. Time, X:XX Anderson his MD San of following those afternoon Friday you oral will Diab can't of a call

you tomorrow. look So we forward to many of with speaking

chronic an So for first and NKTR-XXX. with update starting pain

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of new date PDUFA from new were to our first period requested, studies liability is were XXXX. NDA. FDA at This liability didn't and action FDA received require requested studies time the data these the We We we would January. now completed additional its to these time of the continue to FDA for date preclinical NKTR-XXX, data to studies these review The more cycle quickly end further NDA review agency by the the filing. support that abuse our anticipate in from new FDA the early the submitted process. to on were preclinical the studies and data in incorporate When into review closely throughout data package the we the that The FDA work conducted, extended during review the us two abuse allow that has we've the month, been XXth, NKTR-XXX with the from notification that Nektar development. done the extended, August the informed which as a they review

remain months. major information our NDA constitute our dialogue date the FDA However, an NDA. committee the the to to with us our review meeting hold of engaged determined to supporting was entire as advisory we've the stated, data The very throughout extension a in NDA three amendment process. plan resulting We to that PDUFA I been by additional submission package in informed confident review that the FDA indicated goal the an active has and they FDA in

However, the meeting date yet said. been not has

this changed meeting we currently advisory an PDUFA, the for committee preparing are With summer.

subsidiary separate NKTR-XXX to this working or of a commercialize important the molecule. established commercialization support have one company capital and a to We more are partners structure on with finalizing

Our optimized. before agreements. meantime, the the In pre-launch ensure to and potential that inventory process launch of the us NKTR-XXX is this access, this approval goal commercial NKTR-XXX. believe will market preparation conducting complete the such to activities production completing and of other readiness of commercial allow is launch we're distribution as We

about the We of and the excited NKTR-XXX role its continue chronic treatment future for to be in pain. very

Moving now to immuno-oncology.

our the expansion lung combination collaboration that first treatment We BMS, of for initiated renal continue added the and in partner restore first key medicines cancer. trials the our with just properly melanoma, the relapse and and arm Squibb, enrolling patients Starting focused second have carcinoma first line pipeline with year Bristol-Myers molecule. metastatic a fight immune new platform quarter body's surveillance cancer with develop IL-X bladder full to on execute XXXX nivo immune bempeg in of pathway we registrational potential line to our to a cycle and to therapy. ago. established to components harness develop line was and following immune the fourth cell a new the PIVOT to this In address doublet strategy on rapidly We bempeg, which and chemo broad cancers in we now checkpoint important of with one non-small cell system order

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these strategy in for patients. used indication of need as who tumors no high XXX registrational underway at it's accelerated baseline. PD-LX who not in levels and their and a study is This first an approval are in Our therapies eligible unmet express low represents patients are checkpoints cisplatin longer medical

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PD-LX results that week recall the to converted study the for bladder of baseline PIVOT matching treatment. we negative XX% expressers in of patients the in third by biopsy had cancer of cohort which You'll

is this will the be As and data significantly to trials of is readout. excited cancer the Dr. it to why presented that the in trial bladder agent expect registrational our for we're XXXX. and the And middle underway we rate registrational and and our of shows population. study GU readout a so first our CR be from complete ORR single reported in in projected bempeg call The already better on at of ASCO inhibitors highlighted Anderson last than MD clearly this Siefker-Radtke with patient nivo checkpoint been week, has

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more in about registrational our the these far As bladder types joint trials tumor in XX about trials starting and first Mary will or in and across talk you so of multiple process know, been development approval the cancer strategy the moment. Bristol with these plan joint XX in had accelerated includes the development plan a of including initiated

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with we balance with us start I'd XXXX and and a deep call registrational on productive landmark full we've with over our incredibly our BMS $X.X financial to on substantial execute Mary, allowed strong like at position sheet. We to billion exceptionally Before that the to that that collaboration comment on and in the year a us cash operational partner. I financial from positions pipeline for had puts us with clinical bempeg as hand support also program a in Nektar signed successful

Takeda being also partner NKTR-XXX is that the NKTR-XXX, Additional move science strong our in and positions collaborations a field highlight NKTR-XXX rapidly We NKTR-XXX the Nektar Eli in partners. with for us and and with and of and NKTR-XXX Gilead two NKTR-XXX candidates with in new for recognized new clinical I-O by immunology Pfizer advanced forward innovation – Lilly. within

continue our team. and over to I-O, turn our clinical of programs. They're with hard like review proud to exceptionally advance that, to to I'd our And in immunology to novel work call the Mary I'm pain. therapies So

Mary Tagliaferri

with the trials like registrational of I'd first BMS. to start Howard. partner set you, with for a our review plans Thank our of

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to a The TKI include with nivo plus evaluate combination safety plus lead-in IMDC will study settings. and In the bempeg third approvals will to registrational inclusive TKI with evaluate will OS. bladder TKI levels. a registrational and for compared risk study, to determine and a second patients first-line cancer the we’re regimen in in The PFS line part RCC ORR, planning TKI all metastatic of in a other a then program bladder, first which trial dose nivo the gain

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PD-LX the conversion our patients in will We collect specific support data also package. study data from to

stage of will second our we to bempeg also and earlier disease classification. a confirmatory As trial unique strategy PIVOT-XX PD-LX the this patients The cancer by and cancer, also mechanism for serve the bladder are as next with broadens disease is potential will feature This conversion cisplatin-ineligible and and development study. differentiating invasive observed with nivo. trial enroll who and bladder stratify trial muscle approval accelerated a status can

patients an to phase, three nivo, free nivo one no will or be bempeg The randomized will nivo During patients receive to and primary or then treatment. in of induction All to receive adjuvant nivo surgery cycles the one to setting. or be one survival. on event presurgical endpoint enrolled only will go plus observation bempeg XXX plus and undergo

planning are and metastatic bladder to patients who include cis-ineligible. a will both that metastatic initiate cis-eligible third are we cancer Finally, first-line in trial we

first in cancer, non-small lung the I’ll second-line cancer, underway. talk lung is expansion cell about cell PIVOT Moving on which to currently non-small

lung expansion are As potentially PIVOT accelerated as population Howard that received an enrolling combined includes stated in The XXX serve patients, earlier, PIVOT design inhibitor in original patient envisions chemotherapy appropriate only pathway. we registrational that cell with could of second-line a patient cohort who in the non-small an relapsed checkpoint arm first-line. cancer

inhibitor also lung a also As accelerated cancer chemotherapy pursue an we options this cohort approval their to population believe particular this has in allow following NKTR-XXX pathway. as could second checkpoint cell patient would disease in planning and that in a to chemotherapy cancer us potential once with With progressed and could this third-line serve limited a strategy, nivo we alone. confirmatory trial non has first-line, trial lung are small compare chemotherapy

plus lung In cancer study nivo bempeg Nektar addition, chemo-sparing and BMS cell doublet the provides to approach. small single compared first-line pembrolizumab agent, of a a regimen planning which non with are

study To first-line the are that cell have We PIVOT-XX in plus patients study cancer. in combines chemotherapy. incorporated are non cohorts nivo finding doublet with second lung bempeg also already end, doublet which non of the cancer, into chemotherapy small we dose regimens cell several designing small a with evaluating that various the with lung

As Howard with mentioned, prostate designs we neck and our head clinical finalizing are Pfizer also in cancer. and

excited Enrollment metastatic are to evaluate a prior in Phase work planned to multiple plus we’ll systemic of Under new mechanisms Xb/X the will PD-LX have clinical Oncology, and neck, will any PD-LX recurrent of for who explore patients two That positive carcinoma baseline the in include We Pfizer combining treatment the X with be Pfizer the not cohort squamous with received tumor both One or and head multiple cell arms. group avelumab very include patient these negative metastatic tumors. bempeg patients Phase disease. collaboration, Oncology potential trial. the with to conduct settings. will clinical

and patients with dose feature X followed combined The by enzalutamide referenced Phase metastatic or either evaluate the regimens. have combinations outcomes in success investigated this study. measure avelumab settings CRPC various plus XX to second and who third or and being cohorts bempeg will a include of based with in clinical specific one we we’ll the on will component more the patients, escalation prior Cohorts to study, XX progressed within Xb in on talazoparib

As dual being Phase bempeg two Howard SYK-FLT evaluated bempeg target Takeda’s inhibitor, with provide is the complementary in oral different Lymphoma. compounds TAK-XXX and a X/X clinical and trial also mechanisms. non-overlapping Since, communicated, as Non-Hodgkin in TAK-XXX populations, cell unique known highly

of trial trials no in more us who expand treatments. study the or with a liquid to development hand area. Gil. provides strategic update, setting, As therapy prior this bempeg opportunity clinical like to are relapsed With least call tumor The first the refractory two prior patients, for a I’d lines bempeg but enrolling that over the in three than at to to

Gil Labrucherie

was expense expense in totaled to of XXXX. XXXX result XXXX. as R&D billion R&D Thank revenue, will recognition $X.XX I $XX.X the you, afternoon Revenue for highlights to Mary, Eli the December million of will collaboration of from of the and XXXX, $XXX.X XXXX a $XXX.X investments. and in as to year then full totaled XXXX, everyone. good our result $XX.X compared XXXX XX, a $XXX.X million of $X.X review Revenue the fourth licensing as Squibb results XXXX quarter ended compared ended included review quarter guidance. We million December collaboration. XXXX the million December quarter quarter Meyers the $XXX.X year XXXX. of collaboration. of and fourth license compared with $XX.X of XX, cash our the XXXX billion financial was as months start of fourth ended in for brief NKTR-XXX as revenue XX million $X.X XXXX million, recognition with up million, billion for million revenue, I ended included financial a the the $XXX.X XXXX. fourth and of of fourth NKTR-XXX, Lilly compared to quarter Bristol XX, in the in and

of primarily other development primarily to NKTR-XXX. the in million as year compared of and $XX.X expense advancing development fourth $XX.X expense. bempeg the for Our ended R&D programs and development with share in and XXXX. for G&A BMS inventory December was stock of fourth our XXXX, of increased of NKTR-XXX, XXXX to for compared supply the $XX.X program expense million an compensation BMS, result and activity the of activities significant a as included million net in in well quarter expense increase collaboration also full as IND-enabling bempeg accounted XX, as R&D bempeg, to costs. to a the expanding combination clinical broad and of of to expense expansion XXXX R&D manufacturing support program quarter expense is year clinical sufficient NKTR-XXX. due million G&A $XX.X XXXX, increased non-cash NKTR-XXX

recognized For and million share basic net diluted earnings to the year share, or net $XXX.X compared in $XX.X a or loss $X.XX per income ended December net million loss XX, per diluted of XX% as we of XXXX. XXXX,

to expect of Now financial at million let’s of XXXX billion of to cash $XX turn the with our to funding result approximately position, a XXXX due approximately with receivable the end end $X.X a as Starting $XX our we XXXX guidance. annual with from balance BMS million cap.

$XXX and non-cash $XXX million the million, million royalty We $XXX non-cash includes be of our reminder, XXXX includes cap royalty for and GAAP in cap in is the XXXX of year at to the GAAP million between R&D we be expected BMS balance end commercialization $XXX includes by MIRCERA the We monetization. anticipate collaboration million related million prior anticipate of expect due $XX of with and CIMZIA million $XXX from over and XXXX a the activities four revenue to will that between from depreciation of expense approximately cap XXXX. and collaboration $XX of approximately the reimbursed a XXXX. GAAP at $XX we As reimbursement in obligation $XX approximately quarter, ratable MOVANTIK during revenue reach receivable million in $XX project and $XX quarters which this to million and and to fourth million incurred the fairly of XXXX. to revenue development QX us the $XXX $XX joint be end ADYNOVATE of receivable will the occurs to XXXX, funding the expenses which extent, will the revenue to BMS bempeg. R&D BMS compensation annual excess royalty cash million of stock of a range by million the To expense. of million

We expect expense R&D a of quarters four XXXX. incur fairly to basis over ratable on the

As to quarterly the to registrational development plan. with reimbursed is XXXX in R&D amount expect investment budget points our we of $XXX funding R&D that R&D of us includes portion our incur arrears. of development highlight broad to guidance GAAP BMS represents partner for in There a are bempeg which in investment by want A joint few plan the our amounts beyond cap reminder, million, key of significant the R&D our that executing our I we BMS. are

joint have registrational registrational multiple supply XX% and share approximately underway cost plan cost. is of and studies cost more We Nektar studies XX% study development of planned. bempeg with many clinical of manufacturing

other also BioXcel important we are addition, our in including bempeg under combination mechanisms of collaborations making with and investments In action in Takeda, Pfizer, Vaccibody.

inventory our expect the drug build supply plan as to investment XXXX, development clinical bempeg for be to support manufacturing multi-year we in significant We bempeg.

of approximately manufacturing in a and supply reminder, shares As generally BMS XX% bempeg cost.

Lilly’s For NKTR-XXX, from of and Phase Phase will Eli to program complete through Phase this in Eli Nektar will clinical conduct planning second ascending lupus X and lead the in Xb Phase costs development study the be half studies of autoimmune year. in Xb the share two we to Phase multiple Lilly new Xb is dose approval. conditions X expect XX%.

Phase year. study in this with this plans with NKTR-XXX, combination to bempeg the a clinical later study year initiate expect We complete X X for to Phase

IND initiate file to first we Phase the of plan the For study and in an the clinical program. X middle this for NKTR-XXX, year

readiness later following year. approval to NKTR-XXX, necessary potential invest support NKTR-XXX activities launch in For regulatory continue and we this to to the commercial approval

NKTR-XXX preparation we $XXX to in commercial between prior into included NKTR-XXX is which and will of our includes potential commercial for non-cash this year. G&A capitalized million expense G&A XXXX stock addition, approximately for expense. costs and the and marketing that In approval. $XXX initial R&D $XX be depreciation investment complete the launch for expense compensation not supplies inventory in following projected later are includes million, an and launch manufacture potential to expense of In in commercialization XXXX, approval million NKTR-XXX

million expense $XX For approximately be and $XX will million. be will income XXXX approximately interest interest

expect $XX MIRCERA to and the recognize approximately We monetization. interest related royalty expense in CIMZIA million to non-cash

earlier, to operator, approximately we approximately with $XX plan with call $X.X questions. together in million. open and And I’ll I the million BMS reimbursement of XXXX for development end that a receivable billion As cost investments, stated with to for $XX from cash

Operator

[Operator you. first JPMorgan. from our from Thank Instructions] comes And question Fye Jessica

Your line open. is

Jessica Fye

the couple I’m think trials, tomorrow. a comment And enrollment And the any that and seeing guys, mentioned, missed if way cohort pivotal evening. in a question. XXX think Are I study? going ongoing we back fall, September year kind on sorry, number about that. a that were you the about I you it we want also conferences coming clinical XXX taking the in with progress we before the just appreciate enrollments there make any your mentioned think cohort. that for enroll in to beyond, releases melanoma updates is might I’m the should potentially – should of when that the how of November on caught could think data? Is there that you. ASCO? Thanks I a then you of curious might of still to I patients lung about second-line data and upcoming expectation? take Thank sure something coming detail I at updates when Hey additional on good just and my the next clinical expect besides data

Mary Tagliaferri

you the Mary. for it’s questions. Jessica, Hi, Thank

any September. year, which plans in to will So the PIVOT-XX we this prior made to we the from haven’t then be present lung presentations And about as data any to mentioned, at have targeting present announcements fall. Howard And Barcelona ESMO is which International our meeting in November. in triple Symposium, XXth from year the we at Miami, the cancer September. then data to And Cancer finally, quadruplets in in also we’re breast cohort Paris this negative CRI plan Kidney in

a would study data we which In X patient expect potential X melanoma study in for terms have summer year. readout months was previously the you’ve in And to of of primary you accelerated then you study of for And in. XXXX. these shared on was data patient I a XX we Phase of in bladder, with that schedule in then, trials, study cohort the first the cisplatin-ineligible endpoint XXXX. we’ve We PD-LX are of think, half lung And for and a Phase have terms progression-free that our negative registrational with have cancer to the have and our as approximately we patient after asked, the in our XXX September in the patients, this first all is cell survival plan non-small approval. second PIVOT-XX, shared in in

Jessica Fye

Awesome. you. Thank

Mary Tagliaferri

Jess. you, Thank

Operator

Thank you.

Our comes Chris from Shibutani next Cowen. from question

is open. line Your

Chris Shibutani

instance, us combining you general. in the any partnerships agents? Thanks that more combinations? very from you you some much. Pfizer, Are Can the area prostate is relationship I-O have restrictive that how other it’s updates, to you were We have for data do prevented outside able other exceeding with appreciate that relationship interesting all you, with with of remind that the Pfizer? The of Bristol. any develop Are including in

Howard Robin

do the contract. not with as work Well, free – are company any we’re BMS fall for indications studies outside as long as as Thanks clinical – it yes. and Look, BMS within the to long the of not collaboration is question, Chris. the the not

free Now anyone like. head consequently, cancer fall not we’re the BMS contract and with and prostate work do neck cancer to we within and

Chris Shibutani

by that with do you’re prostate there? are within neck and someone Pfizer still do if than then able any able work with to and head or you so to And other

Howard Robin

Good we And That’s Pfizer relationship question. exclusive. with is are. not The right. yes,

in with work companies prostate and well. and neck So other as we can head

Chris Shibutani

in done we at a in then the was at the to when the And lung some up be a component coming PROPEL Is some that Way there some was there ESMO initial with fall. in that study. work pembro forward future? to data thought back of point Okay. data to share look able

Mary Tagliaferri

as change change to from PROPEL Yes. of in due data year of this you Mary. of half Hi, standard have anticipate Chris, know, We the some the PROPEL the it’s study and second we care cohorts study. in of definitely, do

Chris Shibutani

is that subsidiary a the you terms based from that the you you Gil, think Are the with models described looking this ahead? for I’m XXX? going then help of And at just you. have upon will breakout year the happens to what Thank regulatory separate paying for Great. group the in in that that process distinct somewhat accounting guidance? be us dependent about where our Can

Gil Labrucherie

Chris. Yes,

wholly-owned So subsidiary the it’ll be a that financial. consolidate will

probably as we we subsidiary, begin we include So will the – for some to information segment separately. account on will

Chris Shibutani

Great. much. Thanks very

Operator

Thank you.

from next Paul Goldman comes Choi Our Sachs. question from

is line open. Your

Paul Choi

I design have taking for for Mary. thanks Hi, questions. clinical two questions our trials

months regard with few you’ve to well? is June. to you thinking are planning frontline? with fluid step in second, see lung in coming near as fact the got the waiting that are for for giving trials the and then that coming regard questions. versus term? the up respect planned past future taking using And here pembrolizumab with combination First trial, in label PDUFA about for in decision the up RCC, the what for that’s of the the the TKI here, extended How agents updates potential just Are our some as pembrolizumab data to Thanks rate comparator to limiting monotherapy you that data you

Mary Tagliaferri

Thank Hi, Paul. you.

So one consensus there we unified spend not first-line of treat time is with a oncologists. And patient. about GU a to how lot

with XX had and for axitinib of median whereas said, prefer my months. physician would He inhibitor survival of prefer of and that interesting second-line a have the I-O other comes progression. less PFS have progress, of to sequential months. with toxicity. my TKI, would XX progression-free nine around of single save or conversation forward with with at end a their median progression-free to lot around of patient a patients the treat treat inhibitor. checkpoint patient who to people pembro agent could patient a treat a Some with if a in a median with patients was combination survival single with move with patients the months TKI. a And pure toxicity I I regimen then then one place that the up checkpoint treatment, end a really a plus contrast, said, And six five same agent TKI with And

cancer the patients at FDA patients, be of PD-LX expanded that mean, knows I-O have positive is should include versus if who standard will broad single the to XX% really modify then terms today. lung will X% treated mindsets baseline, agent on created disease pembrolizumab allow And going for how they people very pembro we be not the would population. but only strategy certainly, a treated to will an care end, how patients frontline pure strategy so regimen have label that than to a development combination. into perceive And And we’ve based the to is various our clinical the with about a what nobody And a the KEYNOTE-XXX current the point, I an of I-O raise TKI trials, in great XX% approve you plus greater yet, also data. have

[ph] questions. Our to is in the plan disease care standard is baseline. greater your in for the that top compare XX% population, is you express of at patients pembrolizumab only positive of to monotherapy to tertiary than Thank where one PD-LX

Operator

Thank you.

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

is line open. Your

George Farmer

thanks and have Hi, updates yes, the co-primary questions. a a endpoint of of trials on you response. the overall X RCC not it wondering include the my also also – other as I’m done. that’s PFS a on case in as said, if primary, still in have thank progress. lot ClinicalTrials.gov, Phase why there’s these phase taking another study your I all for And question about the for

Mary Tagliaferri

Yes, thank the you question. for

CheckMate-XXX we and about the allocate of at at looking allows of in overall to in terms us CheckMate-XXX at one. actually look positive see when hazard And patients versus months. a negative survival those you of for look at patients had see if data, PD-LX progression-free can the you ratio positive ORR, survival, do achieved PD-LX of that data ratio with that an closely only So include XX you’ll believe, amount in terms that label. the then overall a disease we that ORR endpoint survival And hazard small we you our can the the patients, alpha, PD-LX

actually moving important to of alpha probability also, the course, amount definitive that And believe the end the is the technical of so endpoint of allocating patients. the really highest forward survival most success and and of That’s our overall provides largest we point. to

George Farmer

pre-commercial Okay. your And that on when expect to on Do little anything then what drug, can actually this needs can a there XXX, before activities that? you else to you you’re describe launch is bit do of you sort happen receive engaging you in? – approval? Or

Howard Robin

now payer building Well, squared a to working and sure have product addition making for I we’re most launch the doing distribution we well important as with setting is sufficient up think that engagement well appropriate thing away the inventory in that channels. as

couple typically So scheduling DEA approval. months take can to we a the have – after

getting communities the So is to, that that course, that. channels engagement of NKTR-XXX for we on understand working what – the making in making done, of we the is have sure meantime, in distribution and that But those wait sure what the people we’re setup payer have process we appropriate currently.

George Farmer

much. very Thanks Okay.

Operator

you. Thank

Our comes from next question Duncan from Jaffray. Alexander Piper

line open. is Your

Alexander Duncan

for space Thanks associated characteristics many good is with activity. IL-XX therapy Based on question. the cell immune the evening. Hi, for evidence positive in cell

players intention of out to asset? a at cell the clinical AACR? collaboration planned your space that value XXX going you. to in And what extract how for of So the significant the are therapy demonstrate you beyond full with value presentation Thank are

Jonathan Zalevsky

a Hi is Jonathan there. This Zalevsky.

in a aiming of very Cameron first also founders demonstrating who of at There field. they important we’re foremost, persistence component into of of clinical Hutch with early models. some the so an controlling with antitumor And Fred they’re When maintain immunological us in effect inform NKTR-XXX attack are models we the collaboration Research preclinical we’re to are original Cancer studies, then and dynamics really the states. of these yes, closely working is the exactly And and that well Turtle, their So studies. NKTR-XXX. active the to colleagues move the of Stan maintaining Seattle we kind develop do can Center, we’re maintaining how up studies conducting Riddell how cells, their on of that then CAR-T these some the govern how the

CAR-T. And of overall the effectiveness of are evaluate where we are use cell CAR-T it long NKTR-XXX in the setting so to potentiate term there plans to can therapy,

Operator

you. Thank

from question next William Andy comes Our Hsieh from Blair.

Your open. line is

Andy Hsieh

Thanks for questions. taking my

So one follow-up for JZ.

IL-XX are be combination, administering So patient? you terms concurrently the phase, of the expansion or in ex-vivo during to administered it the will CAR-T IL-XX

Jonathan Zalevsky

Well, great question. Yes.

administration. intention, clinic studies there first studies which that what are conducting our to use after along preclinical for we're So we're NKTR-XXX is is and or CAR-T the ultimately now off, with the modeling

stays it or the of is the use So is. doing while culturing so of cells as you're CAR-T normal That in transduction to protocol. sort any not the our aim or

activity, to to after administered use the maintain the goal Our the the capacity tumor CAR-T the killing is and to they're patient. IL-XX function of

Andy Hsieh

Interesting.

Okay.

basically not just throughout dosing more a induction the more of it's a treatment So maintenance but of duration.

Jonathan Zalevsky

Yes.

think undertake of could that the seen that of IL-XX. One the treatment, it ways we've is in you about that CAR-T levels patients

start levels patients IL-XX to higher correlation the tend can even You a of particularly better that response that tend see patients. circulating the of as conditioning the to see a given higher and efficacy those persistence maintain, they the longevity of during we regimens, and those change to was that the and have IL-XX, but to levels overall and CAR-T to CAR-T administration the have

recapitulate that benefit patient use biology the trying So then do we're maximum completely bring CAR-T the to that to to that is what can give them. NKTR-XXX to and full

Andy Hsieh

that And have how Okay. on of guys just educate at this in close a that would but to us invasive? want And accelerated these is, GU, the just ASCO from approval? a get or confirmation UC – some about I is clarification talked FDA's I for are just metastatic before histologies muscle two these terms different because versus how reason from – know enough you to UC perspective as use perspective, of allow you is to terms in biology histological

Mary Tagliaferri

Yes.

that and a lay an to approval and the benefit FDA our prior have should a to bladder also did to the in we accelerated to had our a how in GU, serve XXX potential within patients were that of with be that they say superior muscle risks study our meeting ASCO care. to of get cisplatinum agency during as patients. standard did doublet because agency will endpoint. meeting the the face the we So, who had opportunity we that with confirmatory And did we survival we free the And could conducted discussion about trial And about able study potential face to ineligible, cancer the going invasive to – trial. event have opportunity approval, for to be of accelerated are out to plan talk confirmatory

Andy Hsieh

much. very cool. it. Okay, Thank Got you

Operator

you. Thank

question Yang from comes Our Mizuho. next from Difei

Your line is open.

Unidentified Analyst

you And NKTR-XXX taking Thank Hey, combo. cancer, on patients one how at is guys. This part NKTR-XXX? do When good question. on Difei. than the the on metastatic inject where to as you're the in protocol, plus actually of inject can decide you for had for here with looking Alex NKTR-XXX afternoon, lesion? I you one more

Jonathan Zalevsky

Yes, sure. JZ. is This

protocol designed, permit we that to non-target the So NKTR-XXX only injected way lesions. to is be

at not first the a is screening the non-target going every And And of concludes. once only we injected, And be to per those of lesions have patients preferably know, target And and to to those of efficacy inject at week up in these XX lesions, trial be patient sampled overall all permitted are so by because radiologist one that NKTR-XXX biopsy, and those design Those radiologist tumors assign the normal have as lesions important and for patients can is weeks more we the require the And more you require very are into because one the when of than by on non-target criteria, But the measured of are radiologist. by one as cycle. of be are then millimeters interventional target lesions XX addition, least some lesions. scoring lesions. injected between their what to dimensions to lesions in two QX administration have assessment injected this lesions we non-injected, of allowed non-target are RECIST component given the that in millimeters trial. will terms that's occasion enrolled the a the by both we size. and is to non-target then like than three that in number the

Unidentified Analyst

much. very you great. Thank Okay,

Operator

And Thank you. Goonewardene from Intelligence. next Instructions] [Operator our from Bloomberg Asthika question comes

open. is line Your

Asthika Goonewardene

of you Hi, if guys. Thanks questions. taking them have flurry mind. for I don't a my small

you second line, are you lung start in non-small me, agent PD-LX squamous considering well as single non-squamous then who let's the line So you been a that's recruiting also Could started. first are might've And cell high tell PD-X had the study patients? with patients as setting.

Mary Tagliaferri

question. Hi. for Thank Yes, your is Mary. you this

the will second in cancer lung cell we line patients cell study, So carcinoma. and non-small allow squamous non-squamous have both who

for chemotherapy be have order had days to in XXX for checkpoint enrolled to cohort plus disease had that have You a have these inhibitor a and to to patients this stable cohort.

Asthika Goonewardene

Okay. And on please, then study this what's Mary? the endpoint

Mary Tagliaferri

Yes.

trial we've is with designed response the show know, the probably And standard objective superiority is roughly rate this and way docetaxel care. So of to as X%. standard be care to second docetaxel you would of in line

significant imagine really a benefit standard show double rate, would of response could can care. over it the you so And if you

Asthika Goonewardene

Right.

Okay. Yes, to rate plus PD-X a I told had response to FDA X of what study. and go still was remember, I going confirmatory because them a that sunitinib at XX% was exactly Phase

about about your just was So I thoughts wondering that.

Mary Tagliaferri

the readout time is again, with FDA. your with to our certainly FDA one available And the conversations In fortune potential had have good at the program, you to about a discussion the of conversation all accelerated use Yes. for And the to agency, approval. had have a we've entire number of with an This we the always PIVOT-XX the ongoing the you of data. superiority therapies show of

Asthika Goonewardene

then… great. Okay, And

Mary Tagliaferri

third this Just a just in we're be confirmatory that point wanted lung looking non-small on also planning one at that trial shared trial have NKTR-XXX too, And chemotherapy cancer. we we to second and specifically and nivo We chemotherapy. will this cell versus call other line plus I add

Asthika Goonewardene

Brilliant.

gem/carbo that to you potentially quick the for just agreed second first shift give negative. line gears to setting. – to FDA cancer, indication Then a real Has the Thank this in Okay. that. you the PD-LX bladder line use

Mary Tagliaferri

Yes.

low the a let benefit this inhibitors that PD-LX carboplatinum. pembrolizumab, that's cyst checkpoint focusing are PD-LX know, ineligible when population In this cyst ineligible population. population. we going as don't you in patients plus ineligible the be is XX% patient the FDA gemcitabine to study study the know, of low first atezolizumab eligible aware, be XX% in treat compared for those that assisting survival with line to that's of you a said, on just see and as to PD-LX monotherapy So patients and low XX% of the cyst you overall or an the study. an exclusively We has population going you such as are may cancer approval And you is with that who may be bladder actually would

Asthika Goonewardene

Sorry.

bempeg is then going two bempeg and plus the on have arm to be one nivo with arms onto to gem/carbo But in on nivo. as progression, right? You gem/carbo patients that you're have study, well. put going you And

Mary Tagliaferri

correct. that's Yes,

the would in patients. potentially have really endpoint analyzing and we accelerated third XX allow is rate be about for to So or is ORR look that overall in with you line the survival line what look could could situation, at our benchmarking third response at population that a And, rates patients to response and what doublet. an what approval for would look at patient

Asthika Goonewardene

one. Last Okay.

line in to the that's trying analysis, versus randomize understand specifically superior show robust TKI, given it On versus to bempeg/nivo versus gem will statistically X? just are you first that you how I'm cabo your that? how Sutent. a RCC, subgroup the X Is data

Mary Tagliaferri

Yes.

the if randomizing cabo in be progression look CheckMate-XXX you to at to to I Sutent trial, X. survival going actually, actually – the are it cabozan we think similar of X study. So, And in performed the free

study designed so CheckMate-XXX. we've mimic And to our

and that Sutent be believe to similar feel cabo have the way we like performs it accounted for therefore, And will we so cabozan, that. And did we CheckMate-XXX. it of

is for scheme X XXX to patients. X randomization Our the

So Sutent. course who will versus we'll have patients receive arm and we by stratify XXX patients of each in cabo

Asthika Goonewardene

you Thank much for all so to detail. Great.

to fun forward guys. a Looking year you with

Mary Tagliaferri

Thank you.

Operator

that for turn you. for conclude I'd the our to Robin like call today's Howard over conference. to now session question-and-answer remarks. Thank does And any back closing

Howard Robin

an joining Well, shots broad I-O on goal. we pipeline year and for for XXXX, we had thank everyone have incredible of Look, exceptionally you exciting today. we've number in great have and us an a

we're strength. comes some about pretty with that. And So impressive excited that financial along very

this, of I and our to their results for employees for all So good a of want lot year. hard from Nektar you'll thank And think see this dedication. work I

So for thank you joining us.

Operator

conclude This in participating conference. and gentlemen, today's for thank the you program. Ladies does

Everyone disconnect. all may have wonderful You a day.

Nektar Therapeutics (NKTR) 28 Feb 192018 Q4 Earnings call transcript