NKTR - Earnings call transcript Q1 2018

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Operator

Good day, ladies and gentlemen. And welcome to the Nektar Therapeutics Q1 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call maybe recorded. to host like Ms. today’s now would introduce for your conference, I Ruddock, Relations. Investor Vice Jennifer President, Senior Please go ahead.

Jennifer Ruddock

of us Officer. Robin, Krystal. Scientific our you Labrucherie, our joining Tagliaferri, With Chief to Mary you, our Officer; everyone are Several Thank Good joining Dr. Chief from our Dr. our for and us afternoon. Chief Financial locations. R&D team this Dr. Steve CEO; Officer; President are Chief and our And members Officer; thank today Medical Gil Howard Doberstein, afternoon. Zalevsky, Jonathan different

over website Howard? statements of forward-looking With clinical no which difficult if for Howard. risks is today, guidance otherwise. potential this uncertainties regulatory the which candidates, plans, will to So drug I partners, any patience our of make well business, on at XX-Q clinical economic statements potential subject a earlier be filed therapeutic we of set or call Nektar’s ask available collaboration trial your the the now Form XXXX A statements expect our plans, and timing that obligation we the uncertainties are page we turn relate many that, for forth drugs update the of lag to this developments is and the to sec.gov. are and as nektar.com. today at our Important call forward-looking our of risks are and predict inherent On results, will IR information, of are undertake to We outside future, and control. of to result during and responding. certain clinical in at the new the other whether they webcast future business. available Because Q&A as regarding regarding our financial future our future including there forward-looking development in statements those to of any of as partnerships, call, trials certain

Howard Robin

an Thank XXXX next progress month submission the us year everyone you and being now in IO achievements continued our NDA NKTR-XXX, milestones we for X recently months, occur first as NKTR-XXX our and which for will quarter call. XX you, this and conference with today’s of the beginning our for program pipeline thank the immunology portfolio Nektar’s call joining planned Jennifer, our of of and our the entering review study, NKTR-XXX. our over NKTR-XXX as initiated this our advancement to including On with well REVEAL since today trials for Phase evaluated will

tremendous harness to fight that a address immuno-oncology, job the on system cancer. full of immunology We and will components focused which also immune pain, Nektar FDA remain have restore achieved month. submit update recently collaboration, areas, to immuno-oncology, and the with of guidance in to potential three for we Bristol-Myers multiple across the medicines In order we our incorporating strategy develop of the our interactions upfront immune I’d of the pipeline new XXXX, our we team both received over FDA the surveillance NDA as to done to cycle pipeline In preparation invented guidance. body’s the immune a NDA medicines the in Nektar, this will year of several at therapeutic the acknowledge chronic this have the FDA the our last to-date, Already, area incredible Squibb with here properly pain. key financial efforts the for like closed. of we NKTR-XXX successes they and incorporating months payments the

I’ll nine tumor with as backbone goal in collaboration, candidate rapidly NKTR-XXX allow of over develop to indications. this trials we of have believe patients this us Phase immunology, we NKTR-XXX We our multiple will lead our about with a multiple April BMS provides broadly now being this advanced across the dose a types. became in new week, announced care lupus of establishing this of in NKTR-XXX achieve talk and Our you which progress patients. a us more IO effective XX cancer the as of saw trail moment. also program platform And to registrational conducted in into ascending in initiation Xb

their start is our executing on I proud XXXX great am a to for of our strategy. and off very efforts So employees in

let’s review productive which and in assembly interactions and amount our our package, to X,XXX know, the efficacy over includes and led NDA an meetings first extensive data patients NKTR-XXX, healthy highly So of agency of as pre-NDA subjects. you with safety

this earlier, an and also the helping right therapy, important said current time, new the NDA clear NKTR-XXX to We accessible potential the given pain I FDA incorporated public our that collaborative month. NDA while at to is we will emergency. offer us opioid submission. the health chronic submit into We suffering address emerging believe from and by the patients guidance As to

without today’s to Our of mission drugs. with the pain opioid to was Nektar-XXX from abuse its and risks patients high addiction provide invention relief found with

of potential no following longer our against value as help the major medications new for mu-opioid finding patients, developed new addiction molecule financial opioids, is properties stem conventional near-term a our strength back-end fight no the but way block highly NKTR-XXX is focus reduce NKTR-XXX, current NKTR-XXX possible. opioid diversion agonist abuse. of As approval. to inherent full retain rather as medicines country. an but for is for -- not unique bring to in new building position the the a in our economics to best pain to be prescription remain company, NKTR-XXX’s important We drug the years, patients not to this important to only rate of and but is addiction to focused in first over significant Because the on much XX also to only of quickly therapy

are several the of we strategic for commercialization alternatives structural such, evaluating As NKTR-XXX.

more the development while majority-owned or this of molecule. separate shareholders. one efforts for to of our approach launch important value Nektar’s on One resources our immuno-oncology strategy our establish partners consistent focus which immunology of maximizing NKTR-XXX and pipeline, This to and is to with is subsidiary, the with a

about let’s talk NKTR-XXX. Now

start we this third begun and of clinical possible. into quarter as potential advance trials end, regimen Squibb a collaboration you extremely in to the we as program As for in most quickly that important for Nektar The development planning Joint of already recently to as NKTR-XXX to program have first Phase know, steps Bristol-Myers year. patients the development the Squibb. pleased To as Bristol-Myers entered intent clinical transformative combination with next X is NKTR-XXX. many this the planning broad Opdivo possible we our with are that are IO in

first meetings. and first in plan and cell year’s line to The first trials two this we line share the preliminary carcinoma, at will ASCO melanoma renal trial be designs

cell this lung cancer. of plus trials approach priorities for first in approximately are over XXXX, this was is top one different the BMS and be highly are from and Squibb nine the Under trials also XX session launch we’ll renal and the which abstract multiple enroll tumor XX,XXX collaboration, melanoma, cancer, focused half in our Nektar our We second Beyond presentation NKTR-XXX new Opdivo in for Immunotherapy that in patients on Developmental of multi-pronged lung Nektar registrational registrational envisions carcinoma of patient oral will to extremely the design ASCO. the at Bristol-Myers PIVOT registrational accepted in pleased Therapeutics types. planning trial were during populations. enabling trials framework that and a

for more the abstract trial, with the data both acceptance ongoing you the from is stages February. oral an abstract that delighted from were an on our The expansion the early cut As abstract includes difficult escalation chose of based database and presentation. PIVOT, so we know, and of preliminary committee

in last is we this which presentation. Citi the consistent an present ongoing updated the data new plan and ongoing at to presented past, including at As how study, year’s is with we meeting, data

melanoma We renal include many a who oral Dizar at from from Diab forward Yale, the cancer also look our specialists will which from present Dr. who panel preliminary expanded three [Dr. data the Saturday this webcast event Gettinger will oncologist, on Chicago include in a with oral bladder and panel well an The as discussion will investigators. of will updated as We following Tinier], PIVOT, also lung Anderson, you to of seeing Dr. and Adi evening, Anderson. presentation, of host from the a Scott specialist, cell event. MD is MD session, for IR

additional checkpoint a for data ASCO. of mechanisms NKTR-XXX of presentation our showcased liquid In This in of addition with beyond tumors. will also solid oral compound both inhibition, to models TAK-XXX with NKTR-XXX, presentation, be there for and our of preclinical Takeda’s action preclinical notable other are number first at preclinical which includes presentations

NKTR-XXX the will in non-Hodgkin’s new a with X initiated includes patients with TAK-XXX just As with in year. which start evaluating second you know, this of Phase study study The we collaboration Takeda, of clinical half a combination the lymphoma.

We synergies IO unique well presentations combination in a excited as evaluating of for preclinical these possibilities the for I’ll about time planned the tumor the are moment, mechanisms ASCO. extremely in NKTR-XXX liquid about first Jonathan the let of as talk of two setting. a other

of an execute to for Bristol-Myers Nektar’s our Squibb signing financial in on immuno-oncology. exceptionally position, we are in now collaboration, us which Following portfolio allows the vision strong

evaluating REVEAL XXX well is dosed trial cells NKTR-XXX. candidate, candidates agonist and Our enrolling eight of a IO-XX with up NKTR-XXX, settings, an NKTR-XXX includes in second was tumor combination both April, stimulate first beyond in to line patients which refractory we with settings. and IO T-cells. as first the patient the trial, NK TLR-XX a as types pipeline NKTR-XXX In memory NKTR-XXX, of and The can which different

of have following to is The NKTR-XXX the option trial assessing triplet stage Opdivo. first NKTR-XXX, the of that, of trial a and NKTR-XXX and NKTR-XXX the of plus will second doublet evaluate the the stage

in have some this data of fourth in We sometime the initial quarter expect of first year. trial patients to early the the from

Lilly. on you Now with of Eli an let give the NKTR-XXX our advancement update me

Xb Phase patients have of dosed quickly cells. in discuss will the been second and we primate in continues this multiple mechanism our Phase human we This from with in has and shown extremely or in in increase the pleased next cells NKTR-XXX are program we announced conventional first first past, increases volunteers that lupus. to our our ascending expect now moment. trial stated As half now we has ongoing advance dose-dependent what that in initial patient the from is Jonathan the saw NK healthy levels models dose with this no of sometime a regulatory comparable And in This T-cells in year. and non-human trial we the we study X more in to T data data in This humans. initial confirmed have week, lupus

new a of bring excited potential resolution the call going NKTR-XXX chronic With and I indications. over are We to disease about to to inflammatory very Jonathan. the that, the as paradigm treatment of turn a therapeutic am to autoimmune

Dr. Jonathan Zalevsky

some science just initiated this. NKTR-XXX. Thanks, checkpoint Howard. still why cover beyond the that with spend and excited NKTR-XXX I’ll then mechanisms time Lilly combining behind other we about I’ll Nektar trial about inhibition the are talking and with And

we As potential many scientifically combine NKTR-XXX. In driven to be Howard our we of is March broadly evaluated NKTR-XXX a And TLR-XX unlock with combination mechanisms. immune that polymer to to immunotherapy notarial mechanisms to agents and complementary science think and the in of therapeutic as capacity, other was of order the approach in agonist keystone where IO. and go trial, designed NKTR-XXX year, inhibition. the mechanism way stated beyond leads expanding establish to regard, incorporate In to NKTR-XXX. in full REVEAL based our used this with earlier, with clinical expressly intra-tumoral are in conjugated which broad this NKTR-XXX a the that intend cancer us have non-overlapping combination checkpoint began NKTR-XXX this there is

arms this combined Except NKTR-XXX immune And use entire when one our body of we frequent into to all preclinical TLR-XX system, NKTR-XXX, adopted in legions in the in the throughout this in combination one we models At targets of adaptive deep immune immune system. of which NKTR-XXX an and NKTR-XXX work with see the we not immune injection multiple individual abscopal tumor case, drive innate the the system NKTR-XXX the of maturation response abscopal syngeneic using the to And NKTR-XXX. the same show pathways with this the two NKTR-XXX presented last modification propagate mechanism underlying engage routinely preclinical of the NKTR-XXX. call mouse to expand NKTR-XXX cell combination injected is response and educate anti-tumor educated function and innate efficacy biological demonstrating and fight together myeloid/lymphoid addition, their and agents to systemic immunology action this AACR target immune showing how lesions we agonist, tumor system As targets to populations of and immune the tumor these even system and We infections. that to control month, the tumor system, engages an of uses data or data response. models. immune and this

In it levels to the activity macrophages by shown the At and lines mechanism clinical SYK-FLT Lymphoma. we very TAK-XXX. tumor that target and solid are multiple trial complementary for as of TAK-XXX is Takeda populations, inhibitor solid of evaluating April year, known this the we cell the dual underway mechanism with treatment clinical robust microenvironment. have non-overlapping compound myeloid already TAK-XXX was combination with first a predicated the developed We will announced suppressor has this preclinical and Takeda’s NKTR-XXX on collaboration of data in tumors. to to of tumors. is the month, designed MX reduce our models shown excited and new clinical proinflammatory preclinical cell in NKTR-XXX highly next the translation levels tumor of these tumor does of that liquid liquid of evaluate and a myeloid-derived present unique REVEAL not Takeda include a TAK-XXX mouse the mouse both stage modeling In action unique in provides Since to biomarker trial this combination. non-Hodgkin ASCO, increased the program

non-Hodgkin’s the are into very will tumor and trial will study setting -- liquid We lymphoma of first clinical the combination later to advance and plus NKTR-XXX NKTR-XXX excited in year. our begin evaluate TAK-XXX this Hodgkin’s

to of patient the encouraging we each mentioned, combination Additionally, In use in as intended inhibitor we scientific presented explore combinations emerging the very tumor syngeneic strong as program The in tumor to ASCO inhibitor, path of specific we well And as for specific personalized peptidase selection are the models move some of combination. combination have Howard forward NKTR-XXX as month. are or doublet and rationale also will is be individual this, with strategy. development mechanisms [inaudible] clinic. at models the data prioritize believe we with cancer with conducting like evaluating NKTR-XXX, for will vaccine that Howard’s with order can I’d NKTR-XXX a the dipeptidyl discussion preclinical expand and of we in on mouse DPP the tumor in we which review patient. to vaccines to and these of clinical for neoantigen-based the all both advance cases, research and And into lupus now the trial just started next partners

well-recognized and our in a NKTR-XXX of notable biology provide and has expertise such partners Lilly chemistry program with Bristol for cytokine for Takeda our as number breakthrough core stage. to NKTR-XXX, and use create This our disease of autoimmune the As by new is NKTR-XXX. to for course, Nektar, now potential evidence great as It have further control of ligand Howard interactions potential medicines. it to receptor pharmaceutical said, large optimize ability

focused is comprehensive Lilly with of development collaboration the NKTR-XXX. now Our on

tolerability dose ascending mechanism-based you is pharmacodynamics is We biomarker As the take then healthy Xa the NKTR-XXX, Phase associated activities all lead of results know, single X and for up from Phase biomarkers This ongoing X escalation Phase study promising of which end onwards. our Lilly evaluated responsible a Nektar volunteers. in will to NKTR-XXX. of in observe the and with trial trial safety, immunological

very several We progressing times the well. trial escalated have and now dose is

in of studies the a we systemic conducted escalation in patients fact, and healthy this T-reg of in repeat dose-dependent in patients study, in to activity T-cells objective as study this biomarkers lupus. of or pharmacokinetics, any The which first signs with T-regs, dosed the cell increases we of level dose the monkeys. as B PD in And increases the far to-date, with serum to track known patients biomarkers, well and So trial conventional earlier T-reg we erythematosus lupus T week, include conventional treated safety, cells Xb multiple also and in stated, Howard observed with results levels, DNA no disease is cell, is anti-double-stranded compliment. Phase ascending will specific very NKTR-XXX. cells, preclinical memory ThXX well NK the NKTR-XXX, in cells, as clinical In evaluation B disease pharmacodynamics, markers the antibodies NK as volunteers evaluate administrations our dose in ratios, specific including changes have and with

Phase index. design the our several will I’d the partner and the in measure will And levels Gil. SLE X of study using hand will run disease to inform study different This the autoimmune to call response indications. that, like disease activity that Lilly dose We clinical with

Gil Labrucherie

good I brief then you, Which and financial from an investments. XXX.X I start with first include afternoon, We Nektar’s to quarter everyone. the million XXXX and Thank of review financial ended annual approximately transaction an of for with to of a the will Jonathan, update of not closing, At $X billion closed and quarter the from payment first guidance. million April billion payments our X.X collaboration upfront XXXX X.XXX will does Squibb give a cash cash billion. that $XXX Bristol-Myers year still end premium with we on X, received BMS, We strategic a expect investment. billion the equity XXXX. X.XX and the to position comprised of results

year-end guidance expense consistent we line annual items first on the with gave were For our call. revenue quarter, our the and

guidance. Now let’s turn to our financial XXXX

unchanged. remains annual Our guidance financial largely

that We as all the now second revenue will ending and quarter completed the BMS X recognition XX, in expect are of be recognize to analysis for audit the substantially of upfront payment XXXX. their quarter. process billion accounted the June our payments have completing independent second revenue in auditors for in the collaboration We the procedures

As result, are full-year raising billion. we to guidance X.X a our approximately

guidance, unchanged collaboration year the XXX remaining the revenue million outside full XXX XXXX. Our of quarters at to of million, revenue from to BMS and over recognized the expect ratably remaining the be payments is we

stock project XXXX continue expense. for between G&A includes stock We between includes compensation million and million XX and of and non-cash to XX be expense. and expense non-cash of million depreciation XX XXX now range to anticipate We million, million million which R&D to compensation expense GAAP XX million, XXX depreciation XXXX XX which to approximately

we plan Billion earlier, stated will I that, the cash Operator? approximately As end in investments. for With I and open X.XXX X.X billion with to to XXXX call questions.

Operator

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

Your open. line is

Chris Shibutani

very you much. sure of a Thanks Gil, things, pretty that’s And you lots guys balance interesting healthy have can do. sheet am I there,

With about hearing we PIVOT. lot been to that deal Bristol the certainly you a announced, forward looking

deal One of also obviously, any we Can of the you programs, the to us Bristol other PROPEL. -- with you’ve for in at combination particular had are PROPEL XXX anything was studies that and a partnerships? there from or give ASCO partnership sense be learning would implications those

Dr. Mary Tagliaferri

first patients line Hi, second Recall first fully cell line non-small in is external those patients could than have enrolling any study bladder patients or on be patients question. you Thank who you is non-small party. lung who small cancer patients NKTR-XXX and we cancer with plus then cancer not and cell bladder in again This have first line or pembrolizumab combining the Chris. for PROPEL patients. that cancer. second who melanoma, have or line patients, run NKTR-XXX lung Tagliaferri. those patients partnership lung And are in know cell greater cancer, patients as asking PD-LX and atezolizumab line is are XX% we have plus And addition Mary a second by are This with the or who Nektar. sponsored

enrolling are those actively We patients.

at not to data have on in year year, are ASCO we this the the would that said second presenting PROPEL but this We data half of we have share study.

Chris Shibutani

amongst partner trend And what -- when Can when process the central to your then data, you helpful how type responses? see process your clarify that would be on clarify? that often is there is see Thanks. investors particular of your for that do do one and debated in just what that’s adjudication thing adjudication we central the of is,

Dr. Mary Tagliaferri

Yeah. Hi, Chris.

protocol, rate Phase our our that’s, is PROPEL objective the endpoint obviously, response per of X approach an efficacy As assessed in study. primary X and both and in investigator terms PIVOT-XX common and study Phase the study most the

approval called does We who been independent pathway data patients both BioClinica addition of well. also accelerated an the response the we well objective the from PIVOT-XX also all in relapse/refractory have reviews and the would an for assessed radiology. with population, enrolled that forward to were rate, of FDA as group any independent as the for to ask obviously, have investigator an If evaluation radiology patient as move

Chris Shibutani

that will And ASCO? should us Great. Can finally, on we the I’ll at remind you Then from in lung PIVOT from of expect lung. Thanks. of queue. then, terms what cohorts get see we in numbers patients

Dr. Mary Tagliaferri

want This Yeah. share Thanks. I submitted. over to ASCO. oral X,XXX with everybody that Thanks, an Chris. to be presentation Well, at first, honored very as year selected there we were abstracts are

accrual ASCO is and And who XXX already safety and naive podium at So efficacy of have cell and for carcinoma presenting briskly. course, that least were the ASCO. renal investigators at given data to at be to going to time shared, occurred the more melanoma are that And we will trial we we the IO we truly a that enrolling Citi, the patients at presented clinical selection cohorts are distinction.

line patients ASCO, melanoma at IV and and therefore, we’ll data the stage largest have fine-line So, first have our proportion who both for RCC of disease.

after that the for a know cut the of cancer in available will in populations. week fewer also let patients want have abstract on in going as came data melanoma patients investigators abstract our next also to to GU February. and are was cancer, those and those I be you early oncologists and handful and We will breast triple-negative lung our have for data

planned Although, current with data to we more will updates be be presented providing ASCO. at

in deepening to regimen to data and are one time to able of who only going patients are important having that, at a and post-treatment the treatment have see understand, And we tolerate present ASCO, patients Chris, as you So over that’s as had stay scan, be the very to escalation well-tolerated. the thing know, many PIVOT-XX we course, response very is our times number other set, on dose continue data we there respond have treatment. is patients in because and of number of of the the treatment a shared patients an on the doublet, they when increase

those we’ll clearly been had to have than patients you So patients on and point the have longer those out scan. study one studies, who who once scan and more

just And at and really X on forward presentation, take so, session I going and want X you the we p.m, this between to on in June ASCO Developmental Xnd, seeing looking and p.m Therapeutics to are say everyone our place Saturday, call that’s to

Chris Shibutani

Thank queue. you, I’ll back the Mary, get in Great.

Operator

from question Fye Morgan. our And you. next J.P. Jessica comes from Thank

Your line is open.

Jessica Fye

for I question. for recognize Thanks focus the lung best at and RCC far we maybe strategies have mature move melanoma and XXX worth and be what areas that of ASCO data, forward a data long there’s digest and But taking is the less numbers kind One of dust set a that a so just the time on your I’d can and one in to only my some should been the kind bit learn get be five little to groups. smaller cohort patients big to I has and such within than itself expect from the might Great. bit ASCO. thinking what we hear settled see update has and cancer? -- should beyond realized stage the at to now been And not more we the data latest of little and curious you

Dr. Mary Tagliaferri

asking question. you Great, Jessica. that Thank for

presented line the IO be line naive also cell population. in the second cancer case That non-small lung other patients be patients will So, of and mostly first the some we cancer the be that post-chemotherapy. will both lung relapse/refractory said, being will presenting studies

our provide were with information and we those an those longer study only will patients over one where have so will mature be update time, about So Likewise, the broad I moving patients efficacy again, who what for patient who I lung but have patients of data to those have on and development forward provide scan. going patient have we you those the moving who been so to a had in ideas how understanding partial that dose of NKTR-XXX we you you to one these the to response scan tell Phase with do, will reported setting. escalation to clinical plan. previously patient we let placebo Remember, we Jessica, enrolled populations with and see line that to second be we’ll populations, can more the know cancer we fact the patients emphasize that provide X want just with to in were are Chris, patient you you had again, we non-small we I that and of our cell I in that study the the two complete with in forward told, and and see on emphasize treated most that want response in cancer to lung

Jessica Fye

about you those address you meaningful, clear you but stock investor has that. to also just the so output Okay. then, great, talk Appreciate realize share been And aren’t give don’t forum why I completely sales. the can Thanks. recent questions? and appreciation management the that the air

Howard Robin

Sure. it. Jessica, I am address happy to

most quite generally I management look, exploration. are percentage for of that within and think, year the are frankly, the just -- ownership part, and put you of of all were the time shares under plans of -- stock management some sales a of sales you see in team, small that the place been a done the ago have

the I haven’t ownership they carefully, this probably XX% shares of I this if a Now, team at if ask selling if know at but look look you you and it’s of very vested I and at their the myself, shares certainly think think, important always are at still and looking Nektar, been question because -- and I to senior management the own those. at investors they look

look team, we example, So if fashion. I if shares and Nektar, and at the in to a owning disposed I be a in that entire going speak, bank, or management where at team look so of look for my the sitting to as to to probably, shares always they’re say, XX% are you course, do still soon But -- of off upon are vested and have, I expire, of stand I myself right. in the some portion come -- I expiring but still

stock So, sales. I think unusual there’s don’t been any

company know I that potential a with think shares so disposing and explorations, to strong that to exploration enormous but way going say, shares come close exploration. as close come options vested to belief reasonably also team aren’t anybody options that dispose and of a close to as exploration, the management should has I I has stock see well to I and don’t -- they this stake is shares close of is to -- reasonably long go, the

some in hope so of in not that And compensation in and the unusual the to of at XXXX. after expiring. by I I it’s of taken frankly, compensation with performance while question. advantage in when quite don’t are that looking the fashion stock in everybody money So, a I XXXX am understands little options of problem are form of successful I management, see a neighborhood when taking hope people table this, always a shares expiring, off answers that are of and options a far have especially form bit such neighborhood

Jessica Fye

I appreciate that. Yeah. Thank you.

Operator

comes Van question from Jaffray. Piper next our Tyler And from Buren you. Thank

line Your is open.

Tyler Van Buren

questions. thanks and taking afternoon Good for guys. the Hi,

giving of that we’ll the us of PD-LX content, help treatment of a into help abstract, naive see what be will tumor to you how the but head us, understand, contrast we you sort we type, any will see just by ASCO breakdown by it patients. And imagine and could there without we’ll will course, just by experienced will rates response be structured, status, expression stratification scans with breakdown be some see there respect actual oral maybe could and compare presentation? versus a at As

Dr. Mary Tagliaferri

Yeah. Tyler. Hi, Great. It’s Mary.

next were patient in that all week, which enrolling So to abstract, we you’ll included the the populations IO naive PIVOT-XX. see

me, second that line well RCC, patients melanoma, naive, line line, So breast first IO cancer non-small line cancer lung patients, as line first those line first triple-negative excuse second eligible cancer. as are system cell from bladder first

be RCC PD-LX We rates melanoma I show also down that Again, just you be ASCO broken the safety have that and we’ll cohorts. as be well largest response as update. so told, presenting our at status, will will Chris, sharing by as abstract the also cohorts the we to

Tyler Van Buren

just will you with or down to kind it PD-LX status, see or it what expect maybe response historically response of rates that you be of by have to would difference all in rates would we kind Since seen expression breaking understand broadly type monotherapy? be what IO of helpful

Dr. Mary Tagliaferri

could go Tyler, great question Yeah. some depth. it it’s into and a

So that oral we during session. present nivolumab for some during the agent Therapeutic as Developmental of [inaudible] his efficacy as nivolumab, Investor data single data present well agent by and in will also will benchmark single the presentation our PD-LX status presentation

to forward attend encourage you really are to and data. we you So looking specific we all that sharing with

Tyler Van Buren

Great. occurred? ASCO And cut the all us when data in that terms for can you presentation, oral of the tell approximately

Dr. Mary Tagliaferri

Yeah. Hi.

for cut yet data haven’t done actually ASCO. We the

it doing as so, be in we the to obviously, ASCO. are into next couple We going head weeks,

Tyler Van Buren

Okay. abstract? deal Great. announced, that see the was before the in was And the Bristol data did recent all they

Dr. Mary Tagliaferri

that did in see Bristol abstract. were the the data Yes.

were with you and submitted in As we with Bristol-Myers they collaboration the us. know, abstract, Squibb time when we collaborator had moving clinical forward that clinical February certainly our our at

and with billion did happen bank they clinical to see us So made did Nektar. that $X.XX led large they collaboration in the data before for the that very

Tyler Van Buren

a Well, Thank seeing forward mature Wonderful. ASCO. I data to more at you.

Dr. Mary Tagliaferri

seeing look Tyler. forward really We to you.

Operator

from Bert And next you. from BTIG. Hazlett our Thank question comes

line Your open. is

Bert Hazlett

some progress. on With bit there specific for you X after Could decision. potential Phase more to might congratulations are the least if little and moving that. and X regard studies. to all went then at and one pathways, a deciding so, into what what be about Phase those the for Glad into articulate possibilities. any move realm -- you’re Thanks pivotal hear have accelerated Then indications I more the into in to of

Dr. Mary Tagliaferri

Yeah.

RCC any cohorts. shared for we embedded -- of that’s and protocol And Phase patients X as So, has efficacy. criteria have we largest stopping into times, also melanoma many and number enrolled written had the the

we eager ASCO, well which development And clinical we data our carcinoma. program. very to X Phase very will our a melanoma of forward are certainly, broad be we those so renal why as and Phase X some will cell for And move presenting into bridged in at show

the the an have months. and different As cell for to Howard and approval are relapse/refractory are accelerated bladder have multiple within next data melanoma registrational types strategies renal you, pathways believe And we have that approval and is already do on forward embedded we have at cell your we you accelerated efficacy the about to We We pathways. tumor XX opportunity moving And question development. mentioned studies shown we protocol over for potentially shared non-small population launching second do rapidly lung in XX NKTR-XXX that with our of with and stages the various this cancer carcinoma. into to market. answer

Bert Hazlett

and well? you well for how a that. XXX then to to humans with the and potential thinking animals doublet you regard remind And and combination just dosing us a then triplet then with as Opdivo with does the could XXX such from you dosing translate are Thank triplet, combination about

Howard Robin

JZ, that you want please. take to question

Dr. Jonathan Zalevsky

Sure. Thank you, you, Howard, Bert. and thank

number make and scale a developed of dosing to actually us to we model actually and yeah, models we studies understanding allow guide. dose and a lab on translate the do that as a tumor cellularity the the nature to size predictions the age. preclinical like in and the to of tumor animal the tumor of plan of the From So, the of administration using of lot did kind the the how

learned came the and regards of from then, we that So, part for levels the Those to approach And in for first well the strategy from certainly, information have new as your selected, the animal studies. the dose question. second -- injections. all guided as the

in the NKTR-XXX administered protocol. we It’s So infrequent.

to tumors. inject need necessarily we So the repeatedly

the triplet intra-tumoral we NKTR-XXX, the doublet either in introduce be we using So that will the give case is systemically doublet the way or would would we of NKTR-XXX alone then but then necessary if or re-staging of would the upon plus case the stay systemic NKTR-XXX triplet. nivolumab we only therapy would in re-administer and the And patients the NKTR-XXX on the patient.

Bert Hazlett

color. Thank of how up the are discussion this development plan given you do the you you across development broadly, are you frame just mechanism. and got And strategically PDXs data obviously, in letting novelty IO, as the this mind strategy more you But you strategic molecule, I are -- How the collaboration. the the the contemplating and do you for of XXX drive IO a brought guess, landscape you’ve Takeda at you or the and have particular point? surrounding

Howard Robin

No.

is the question this it along, goes to I’ve fall and IO IO all and JZ back behind along, is I starts there T-cells, cells, effector clearly think, what cause T a apart. proliferation know said said is strategy that great that’s of can centerpiece think, I listen, a the effector I which a to without T-cells and without has of molecule therapy

So, because an as what as the we pieces I such have and NKTR-XXX, checkpoint don’t on I are that IO have of we believe other strategy. therapy we think centerpiece a is inhibition also dependent

antigen it carries antigen XXX, NKTR-XXX to it own are new its looking But chemotherapy think such and of we as approaches. going even I with creating NKTR-XXX, also at be vaccines potentially with strategy modalities. look and at potentially we’ll checkpoint methods

immuno-oncology. which possibilities is which things you all the effect. number their short it NKTR-XXX with in combinations then important, even of a and the center believe in with therapies, you prove very all different given can And enormously we of CAR-T or there’s circle very think that that So way should you do think broad if a things can it’s different do of duration

think strategy. have I we do a So

mapped it publicly haven’t out yet. We

companies. are numerous We with discussing possibilities

to see just the study all companies of with coming it the that these a a NKTR-XXX year startup we can want to small with work to see work what think centerpiece. did NKTR-XXX, different going you’re Takeda that with over collaboration, BMS molecule. and allowed with of lot as You outside approaches, are I There’s in we of lot

Bert Hazlett

you. Thank

ASCO. We are forward you. Thank looking to

Operator

Thank you. our from question Canaccord. Arlinda And our from comes next Lee

is open. line Your

Arlinda Lee

for I of my we the maybe see kind guys. or Hi, Thanks duration was of hoping taking the what of at clarify might question. to duration follow-up. ASCO

was is I see we the for secondly, most other mentioned Mary combination second in on and maybe think patients maybe think, a might PROPEL -- the number that if, particular And about in forward just the the was abstract see to is the one then be scan, with a and that the then, that. am is I wasn’t or presentation TKI clear duration in to there maybe strategy effect lastly, follow-up with I scope of do that to of that would And the going pathway or medical JZ, or it path TKI’s there this general what? going half, -- had meeting, wondering Takeda. SYK of on combination something the potential XXX? you that patient

Dr. Mary Tagliaferri

Hi, Arlinda. Mary. It’s

and naive patients on I’ll ASCO the I will we and repeat the have patients, some amount other Chris, data study populations. Jessica as of some of So told such of those longer as patient RCC IO the in most for been melanoma those and at will it, have and populations than

dose of though, with dose the on to escalation I PIVOT-XX update an mentioned, XXXX. December be wanted the patients to recall The providing of other in that enrolled were we patients came those of will you escalation thing those and that first

line to who enrolled have cell RCC do non-small we long-term lung and cancer some follow-up patients melanoma, are So our first cohorts. for line first

so then, long-term to and to follow-up more the to patients a those patients, on now, on forward over you one who the looking will part to escalation cohort and have number we of study will dose mentioned sharing as are then many recently patients only it scan. enrolled JZ, her are I the respond of expansion next the We And to again, to question. turn post-treatment came

Dr. Jonathan Zalevsky

Mary, and Arlinda. Thanks, thanks, Sure.

interesting a you So, very point. yeah, highlighted

that’s to the inhibitor kinase also ligand. FLT-X dual a has very on it kinase And and SYK, activity tyrosine animal. is that spleen So, kinase the the inhibitor, is FLT-X, but response TAK-XXX, is again signals and which it’s alone that selective which

besides particular TKI is And And engage receptor immuno so the the there features this are selectivity. the you two SKY of first really signaling. kinase unique tyrosine with that

also find that kind downstream we gamma And the you and the are control to lot And of is complexes can range downstream ITAMs also we those these case SYK monocytes immune and it granular signaling that’s of cells. the even in along with not phospholipase, as we in controls that of in such types, cell typically know that of and SYK, well myeloid in myeloid a control signaling. in the signaling a representative see on machinery T- others. as highly the key cells So cells high signaling that the enzyme of rely And that ITAMs as different think compartment. for but cells FLT just where

myeloid or with what And very when you cell these to changing that lot macrophages tumors are a scientist discovered the so was mean, of vanish tumor And suppressive themselves Takeda particularly that with the kind almost then of might subset. treat -- have that, these subset, populations very that myeloid unique the the addicted I study cell kind preclinical provide our very increase large a in of is creating phenotype a of in highly they macrophages the pathways, dedifferentiate. populations was and exciting pro-inflammatory plasticity MX of

population and NKTR-XXX with that NKTR-XXX So processes why it this combination does so target is interesting engage. to combine not that is directly cell really cellular

with data We as at results And doublet clinical the agents starting -- collaboration some and very are results strong very, moving a that so presentation these that’s to we trial see this why very, two later because doublet And very preclinically those chance year. preclinical the this led the this very us seeing this into with compelling. see hope advanced first into is a have preclinical I ASCO, interesting. you is

Arlinda Lee

Okay.

Operator

Yang you. Mizuho our from question next Difei And Thank comes from Securities.

Your line is open.

Unidentified Analyst

guys. Good Hey. on is This just the for for have Thanks the taking on combo. quick I afternoon, on Difei. NKTR-XXX and one XXX actually here a question. [Alex]

expecting presenting on you’re plan conference? you fourth medical initial the do data said You quarter, at have in that to

Dr. Mary Tagliaferri

you we have our would the been medical share present It’s practice, tell first at with conference. the patients. like and to already It’s So Hi, you We certainly cohort Yeah. Alex. that that can I Mary. of enrolled

we those we dose have NKTR-XXX, end the by the expect of that so been an of with We have three update patients patients. could provide year

look very we compelling JZ enthusiasm study. to enrolling and a lot with a So explained for interesting have science, excitement and data the and you, patients forward to we sharing of as the

Unidentified Analyst

you. Thank Great.

Operator

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

line open. Your is

Andy Hsieh

for my question. taking Thanks Great.

arm. comparator the Yervoy view comparator, RCC your happy so So, just recently about is to Bristol as what a just landscape, that Phase the know X wondering your started one Opdivo what on -- I there? what trial uses view you that suitable hear

Dr. Mary Tagliaferri

Andy. Hi, Yeah.

that there we do our I cell will And a have are I -- Opdivo for don’t multiple think comparator comparator. arm locked and renal in into carcinoma. trial just we be we opportunities think plus as RCC in X AP Phase designed

technical and trial trial design with We are a is landscape quickly you are all that sharing as trial, looking as of the both tumor goal we where at will moving the standard it RCC of first and to melanoma believe line changing design sharing really clinical trials And types, ASCO change both melanoma first forward, forward across question, of we well for really is the first a to that well the I line success good what design more think the also have probability and we BMS as forward our RCC our strategy. as details about is to high we that strategy, so Nektar care. line look -- truly

Andy Hsieh

Thanks. Great.

So one may. I if follow-up,

with response the So Opdivo. you time deepened alluded XXX over and the to

Yervoy to see Opdivo you that wondering time with updated Just measure with terms of medium have how compare if the . value and in you that response typically does

Dr. Mary Tagliaferri

Yeah.

to to continue as of cell, dose, new an are that the were response be the we escalation Phase provide So, treated as to set on into moving which at as regimen to renal is as more X X ASCO, will a study our our from well with Phase patients the update as moving forward with trials. recommended we that in data, of going forward data the course, to dose came mature time -- the share well you and

cell and ASCO population. time both will response we’ll we updated to So our our providing that be data and at renal melanoma for doing be

Andy Hsieh

so Cool. much. you Thank

Operator

Thank And Seaport Corey from Davis Global. from our question next you. comes

open. is line Your

Corey Davis

very much. Thanks

the word to pathway? quickest to specific in is bit see more lack that can in for to of you able Just beyond a do XXX? way general elaborate things And you’d approval a need for think criteria, be that accelerated little what to of some dictate and filing FDA better on you the data market

Dr. Mary Tagliaferri

you point partnering Corey. on for rate a interval need estimate very that your And objective -- these of prove out the bound what good with they experience XX% are can you able to in we your lot confidence had question. rules that BMS you XX% of standard a It’s imagine leverage with that to topics. confidence as But is that Yeah. Hi, general, of care. FDA can interval for you with response the are lower

terms give which the line melanoma specific relapsed/refractory been where could about objective example to you has second have patients inhibitor, a population, treated be just treatment So like with prior of atezolizumab, those response rate. in checkpoint XX% a a

to want around an XX% bound or where above be lower are response interval confidence would rate see would So XX% you somewhere objective the XX%, above XX%. you

plus in X%. show In of that Phase that the or IO number IO and setting, terms docetaxel line of been docetaxel a chemo non-small response cell roughly trials second is objective lung cancer post large reasonable post very is rate there’s a X comparator the for

of treated interval in lower response rate above IO so, non-small nivo have XX% with And been an that’s or lung of around previously rule the out population confidence doublet objective NKTR-XXX to higher we’d plus agent the X%. bound cancer have an the estimated to that the XX% has cell

patients cohorts that those efficacy. be some calculations, I to ideas. Just need of statistical to that hope help. to you our able give around do we level demonstrate to XXX When be

Corey Davis

explanation tumor great. of better were there work to, alluded broadly, actually it data with much. is Yeah. in at XXX and you to response that just might look there think Thanks was clinical mix? a would that just patients and that deepening the better responses very that And to type RCC are the second the in more tumor That question before predicted a mechanistic be have types

Dr. Mary Tagliaferri

Yeah.

escalation robust lung biological because types, in specific in effect have all non-small mechanism for update line seen our would first perspective, this cell consistent Nektar-XXX melanoma, cancer, for We sense be from of generated we and contrast that after first actually effect six line patients time solid because relapse of an gone, this CAR-T have rate and of is every and we over three months provides this to which be shown dose RCC across tumor tumor the ongoing regression see every T-cells makes antigen to have this these and treatment, why new And replenishment why all antigen a types. in NKTR-XXX ongoing reduction it XX pattern, from days, now treatment. these to tumor are piece see with see a all T-cells tumor those contrast this of generates T-cells XX high you where we that’s new very specific days

Corey Davis

much. very Thanks Great.

Operator

comes Thank H.C. from Debjit question you. our from Chattopadhyay And Wainwright. next

Your open. line is

Debjit Chattopadhyay

Hey. Good afternoon, guys.

plus as chemo prior thinking KEYNOTE-XXX line using what on about XXX Opdivo? your front so start And is setting, for thought cell the non-small a you conditioning process to

Dr. Mary Tagliaferri

Debjit. Hi,

believe Marco Dana-Farber [Volley of going there believe and this an have top with with KEYNOTE-XXX Roy is be long thoracic also we informative including study chemotherapy that’s clinical think we in that first read to year, and of one stage great KEYNOTE-XXX Hellmann will Yale that To are lot Ward combining had oncologists, trial Matt KEYNOTE-XXX at we you line in question data, And it’s very the because to just and presented Sloan-Kettering I Papau] really give I with Scott setting like and we strategy from and and Gettinger are forward both type one out design. and a disease. fully Ad and we IV Board BMS can Herbst regularly we and already you be wanted also well other people we been as to while from and those example strategies line meeting to really looking seeing the tell a Memorial getting input. the and have ASCO the first meeting an

we think to can settings think lung a we trial X that we I designs the best looking digest and we addition the And guide in the chemotherapy at V stage relapse/refractory with with setting about also fully front don’t data sharing forward Phase trial cancer line so Information only it’s want the looking to all are that us is mention as lung earlier to you our while option, and to also more are in population. I specific other stage in option design. help

to and strategy first lung our for broad just So isolated state in line setting. cancer the not very is

Debjit Chattopadhyay

of the from get but the Great. And that? when on the, this I ongoing IO doesn’t question a see asked is and tumor, terms at often, study, know updates sarcoma might cold in this the obviously, market, data sorry, we MSKCC smaller any

Dr. Mary Tagliaferri

Dr. Sandra be know decision data. As D’Angelo this is you presentation eager study the to present that an initiated so making the a will I about know, investigator she study. and in is

she hasn’t submitting with she However, us shared conference that the to. an be will abstract

present. all wait will we have until So and to she the see data

So provide this at update time. a I you able am not to with

Debjit Chattopadhyay

many comfortable study terms powering it’s Echo-XXX in running non-small do the line, both of And the front and a are guys how or or avoid pitfalls of one to cell, whether of getting trying pivotal and before last line you you relapsed/refractory up one in the second patients study study? insight marker terms in need

Dr. Mary Tagliaferri

Yeah.

don’t sharing data think I all at any shared our magic We ASCO. look we and there’s that which number. forward with you haven’t of to

obviously to our multiple IO relapse/refractory to naive, line of well guide well closely the going are totality and of to line, ASCO, front we to you setting very and different are as data addition think lines second we in the biomarker looking I course lung in cancer at in that, our look the think, as at the with as as profile. I at safety excited which share And the at us. data, are we

the you, see will I in of So cancer us three settings believe we’ll with share think number that to data those non-small don’t in to X effect the as all cell a there we guide a the lung but Phase robust magic trial. totality of is certainly

Debjit Chattopadhyay

Thank luck. you. Good

Operator

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

Howard Robin

like again, us many really everyone Chicago. to progress a in lot enormous a thank of joining I’d for to Well, hard few pipeline of our made all which forward. in thank And our I weeks look And moving you you questions. their was good that today, this have seeing we resulted for in in forward work, employees

afternoon. this us joining for you thank So

Operator

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

You have may a day. wonderful all disconnect. Everyone

Nektar Therapeutics (NKTR) 11 May 182018 Q1 Earnings call transcript