NKTR - Earnings call transcript Q3 2018

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Operator

Good day, ladies and gentlemen and welcome to the Nektar Therapeutics Q3 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. I would now like to introduce your host for today's conference, Ms. Investor of Head Ruddock, Relations. Jennifer begin. Ma'am, you may

Jennifer Ruddock

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

Howard Robin

conference the today's everyone the for cancer bladder and for during we NKTR-XXX, also On months, XXXX a as review call. milestones coming patients. in will new joining you, Jennifer well over melanoma, the and quarter us trials for in thank carcinoma today you call, to-date, Thank year this planned includes registrational cell which multiple our initiation accomplishments for XXXX our third renal including of non-small cancers, PIVOT second-line in expansion program lung cell broad and as enrolling arm our

reiterate guidance XXXX. remainder will our financial the for of We also

for with over population. the responses SITC metrics, patients we're As Washington you OPDIVO of control DC disease rate The the weekend IV time, PIVOT from include complete well for data study. as in a response this number presentation know, stage being melanoma including depth as and will important rate planning at Meeting to treated presenting NKTR-XXX, plus the of

will a presentation call of on We safety morning oral host before. X efficacy, data at biomarker Saturday updated of the AM, evening the following and

Cancer Harriet under Center way. patients, the Diab's Yale On our and data and melanoma Dr. which the us Anderson of Dr. Diab Cancer review X the evening's Dr. Adi Center of will in trial presentation we will session. oral the represent is call, previous MD Phase Kluger join to from discuss

patients in In the addition, NKTR-XXX, early also from trial, will presenting we data evaluating NKTR-XXX. be first REVEAL plus the

other meetings, various are tumor-specific data the next Bristol and as medical XX months, X stated tumor datasets the the in to mature each to quarter, present months from and last we As including of conferences. at over each types PIVOT planning cohorts of Nektar

upcoming We February GU ASCO planning of are of cohorts presentation cancer at in the XXXX. bladder PIVOT currently next our from the Meeting data

by reviewing therapy immuno-oncology, and across data very of backbone NKTR-XXX our pain. in and trial start three successes PIVOT areas; multiple medicines achieved future the be to We continue as immunology the about today generated therapeutic we've the Nektar-invented a being the pipeline potential excited immuno-oncology. over in of I'll

NKTR-XXX. cover me let first So

epidemic We same medications addressing don't will existing providing the opioid recognize crisis severe profiles now. new One facing building this the significant that market. that the is as carry medications is our pain right these opioid block on to country

to We of and continue And the FDA with we plans date NDA. FDA the a throughout understand reminder, currently review to our its May as closely to as an during Committee work hold done XXth PDUFA Advisory we've review the NKTR-XXX developments. Meeting our is

not However, a yet. given date we for this been have meeting

last molecule. to in I partners one process are believe NKTR-XXX. we or the is and very this optimized commercial separate will the As us we with to continue more quarter, NKTR-XXX this excited commercial to stated for ensure important future We launch a capital launch subsidiary be the about of allow establishing of

let's lead for portfolio immune collaboration immune body's Now execute for The with strategy allows strong to we gives harness surveillance us collaboration the broad that Bristol-Myers' fight properly medicines on cancer. addressed in candidate, position, to unique an We immuno-oncology. of at which and us restore order immuno-oncology. With financial vision our on and of now our a focused exceptionally Squibb, full Bristol-Myers develop NKTR-XXX I-O platform us rapidly the are about develop immune for Nektar-XXX. system our the a Nektar's this talk in cycle year's remain potential new to to pipeline to components key

been shortly. development share our plan today you of this of a, broad being trials and multiple the first had trials we've talked the development scope across includes initiated in As with the scale types. and to start joint of the about pleased tumor XX reminder, or development a X program XX plan that this initiated with trials collaboration I'm From collaboration joint registrational these

the our in and first-line three trials Nektar in the and total setting, tumor melanoma trial we of is under three are dosed in first and September, a bladder know, each way X registrational our patients Phase RCC initiating bladder you already setting, As BMS in RCC setting. cancer cancers, first-line for and three

us have our of cohort to newly defined new to and second-line with start This approximately population. potential work, pathway provide in lung a non-small trial. added the the a ongoing XXX to cancer of patients patient As this is cancer cell Nektar BMS registrational registration designed PIVOT

these to X over You designs share additional coming And will these a the let trials on more months. about begin externally patient Mary populations clinicaltrials.gov be and, I'll study see posted moment. in

team other companies we've anti-PD-LX NKTR-XXX half collaborate the with anti-PD-X a Pfizer these types. of In are not later addition, agents NKTR-XXX with agents to the Oncology, for of their of as is the partners the yesterday, on us the in data design as mechanism broad prostate in BMS pursue designs that next development work collaboration interest tumor to patient one within the in clinical Nektar that and of and planned additional and BMS need. NKTR-XXX important collaboration importance develop development this Pfizer to immuno-oncology agent the we've running anti-androgen study triplet the agreement, and closely will summarize the Serono's joint of trials generated We've of the be metastatic Merck cell in castration-resistant substantial combinations Pfizer and currently of sponsor announced multiple and the of clinical wave working these Pfizer's for is Astellas based working Mary NKTR-XXX the and arm exceptionally cancer. is several The Pfizer enzalutamide. we very agents carcinoma are clinical with the development at allow with To NKTR-XXX mechanism Recognizing unique the two agent. NKTR-XXX types the neck and with I-O clinical in BMS and agent large we've Under various to this populations tumor in and Pfizer doublet high exciting squamous clinical trial, this neck. will cancer enjoyed we with important most head in Pfizer that program body recognize worked, serve initiated plan, to promising PARP always avelumab, had new new can NKTR-XXX with be that of portfolio to development in from plan. talazoparib preclinical OPDIVO prostate joint collaboration and of first next will a the year. The and and and new will strategic combine of We've the inhibitor of design multiple on this for based you the unmet in new past, types. in an and end, with development talented develop tumor anti-PD-LX head we'll in told so

We are see on will with trials within also several additional two NKTR-XXX, next which to months. clinicaltrials.gov you the initiate planning

and FLT TAK-XXX that's the inhibitor first trial be first Takeda in part with with X to non-Hodgkin's patients next lymphoma a dual year. will in to Takeda's start The as of known SYK, the evaluate NKTR-XXX scheduled with Phase

in Phase a with I-O to next X start be evaluate in with HDAC NKTR-XXX will of to melanoma, trial with year. inhibitor part Syndax patients second plan which also first The is the refractory Syndax's

over Vaccibody trials combination both clinical addition, in partners, will with and two BioXcel, which several entered into mechanisms the collaborations In with new months, new clinical last with include we've of unique NKTR-XXX.

of BioXcel molecule immunomodulator, we trials pancreatic We inhibitor Nektar the their in their these to cancer. a XXXX. are combine neoantigen NKTR-XXX FAB Vaccibody, and small initiate cancer on X/X patients vaccine. collaborating the a checkpoint DPP will half first combination personalized and Nektar-XXX inhibitor of For with in with and combination with plan

our REVEAL and and of the can NKTR-XXX. combination NKTR-XXX, combination IL-XX As which we you which cells. beyond includes agonist enormous in potential. I-O dosed candidate, The trial, pipeline both of is and has NK a stimulate memory the T TLR NKTR-XXX evaluating know, NKTR-XXX NKTR-XXX a April, In candidates NKTR-XXX NKTR-XXX of patients an with first X/X cells

with agents the and demonstrates adaptive in most lymphoid drive work systemic an and biomarker modify innate phase anti-tumor safety, to myeloid of continuing these how combination NKTR-XXX is Our immunology maturation populations response the the to system, together importantly, and determine and individual initial tumor of data trial of control NKTR-XXX and arms cell to pre-clinical underlying efficacy, The NKTR-XXX engage of agents, models. the two the dose immune escalation and characterization. the the and NKTR-XXX PK for abscopal function clearly

the trial NKTR-XXX We a of and plus have will the leader also OPDIVO. option NKTR-XXX, to triplet in evaluate

the trials to Once stated tumor plan as the to as XXX refractory we identified some recommended X trial up at patients share this settings. weekend enroll Phase this dose, from first-line SITC. in with we've projected X clinical types I second-line the and of to data earlier, well As different early

NKTR-XXX another been remissions with the NK In half evaluating been targeted multiple NKTR-XXX levels plan CAR-T to in malignancies hematological cell with of Fred For biology in is that with the experimental IL-XX Cancer for NK us we've CAR-T allows High of IL-XX agonist We have file mechanisms. patients a combination regimens. malignancies NKTR-XXX lymphoid expansion for therapies evaluating first and in and powerful have NKTR-XXX, next associated candidate, studies by driven in with of year. modify cell treatment with our an combination we've oncology application, models conducting native Center. response activation. where the Hutchinson of in pre-clinical NKTR-XXX undergone collaboration IND to duration longer been in antibody

enhance So greatly outcomes, be with excited to mechanisms in we're so potential combined to its well about other NKTR-XXX as as of I-O. the potential CAR-T

our onto program. moving immunology Now

with Let me give our update NKTR-XXX of on advancement Lilly. partner, an Eli you the

increase our now in non-human humans. that saw in the cells. what initial increases in T primate NKTR-XXX the with extremely human shown or is we no trial first conventional cell This As healthy ongoing levels has volunteers pleased from past, confirmed and to of in this has we're in models been the in T regulatory stated in comparable cells Xa mechanism dose-dependent Phase we data NK

We the expect from at Phase meeting complete to first present half XXXX. a medical Xa in trial of the data a

The and bring Xb, with very started patients for the about dose advancing quickly excited to very plan trials the a hand I'll disease cancer and to review Phase over inflammatory Mary therapeutic resolution treatment and to of in lupus. NKTR-XXX BMS. chronic We that, head also in and we're the autoimmune on a X recently to multiple-ascending new trial melanoma, prostate cancers as the the was with neck potential with details RCC Phase trial the clinical conditions. additional Pfizer With in work and and bladder call paradigm

Dr. Mary Tagliaferri

Thanks, Howard.

with head prostate the start me neck clinical and Let in with plans Pfizer reviewing cancer. and first

tumor Oncology neck NKTR-XXX PD-LX cell evaluating arms cohort carcinoma and recurrent Merck will enzalutamide. negative agent, positive PARP tends planned XX%. The to cause Pfizer castration-resistant with include be leading a NKTR-XXX, sponsor a metastatic who in Pfizer trial or the Serono's Astellas's explore under the squamous include Xb/X of for an are to androgen baseline clinical not disease. combining new systemic treatments the of multiple Oncology avelumab, poor new with for plus head carcinoma, the head excited solid avelumab in Metastatic conduct is patients patient with and a potential anti-PD-LX Pfizer's received multiple incurable working evaluate and We with any cancer Phase rate of be and diagnosed survival prognosis will death to has is neck, multiple prognosis. and inhibitor, a X patients prostate arms, mechanisms late to Pfizer Enrollment and very collaboration, X-year a cancer one trial Prostate Pfizer disease American two settings. men. also Squamous very Phase prior and clinical inhibitor, and with PD-LX tumors. and will cell both the Under receptor have metastatic poor be very talazoparib second will

the are the to outcomes third XXXX. start The clinical and a patients combinations and with and and based feature who finalizing plan or to to regimens. NKTR-XXX of Pfizer will progressed a will XX in to Xb C, patients cohorts plus enzalutamide metastatic either investigated followed the X, in have study in success evaluate the X with with Phase one include escalation, in on prior measure study. second reference more dose specific patients being trial component the talazoparib or CRPC avelumab settings Phase will and we we combined by protocol Nektar the various on XX clinical Cohorts

is cell launch second-line trial. lung way. the I'll I'll reviewing will mentioned the in renal some urothelial are the under cell talk carcinoma types and PIVOT which our non-small time tumor also Now which for melanoma, in which plans three Howard expansion and spend about cancer, first registrational Nektar currently BMS

the initiating is approvals To BMS studies advance studies continue to care. we cancer. in are OPDIVO development secure NKTR-XXX in cancer, early carcinoma, separate end, that our with melanoma separate three across settings in non-small cell and standard we renal and lung in potential three cell establish multiple plus many bladder tumor in strategy as to Our solid as first-line registrational types clinical strategy to of

to fortunate doublet BMS, only very we're have immuno-oncology melanoma, for an in be to patients. with collaborating First company therapy developed the melanoma

and BRAF. Phase plus label with survival PD-LX patients advanced FDA care timeline of to melanoma will are of the or the have our be and progression-free is NKTR-XXX the agreed is melanoma dosing Patients survival overall trial projected The stage as Both We of are plus metastatic OPDIVO enrolling comparator by and an under XXX secure status, and NKTR-XXX analysis. first-line to arm. This primary into X way. excited final OPDIVO. XX-month and in endpoints stratified PIVOT-XX study disease with the PFS patient design CHMP study we're open our designed standard I-O very to for

carcinoma, patients, planning triplet evaluate to Bristol separate include Yervoy NKTR-XXX and multiple OPDIVO In in trials more cell advanced this renal registrational For which available the plus Nektar to trials X will OPDIVO and and launch design is in the of Phase doublet indication. clinicaltrials.gov. trial on plus details, regimens and NKTR-XXX are

Patients trial X currently to The first or first patients at of RCC. design trial quarter This either an first-line will TKI, cabozantinib including forecasted has of NKTR-XXX one intermediate plus on trial XX interim poor choice, The one well. patients in will of available XXX of study and RCC the Phase will estimated approximately survival be OPDIVO analysis a overall randomized and time will as evaluate with in physician's risk to status, versus for clinicaltrials.gov prognostic PD-LX stratified choice upon first sunitinib metastatic or a readout is multiple survival months, XXXX. the in by the based look IMDC score factors TKI. be and

The approximately stratify untreated intermediate second patients study and or RCC also The metastatic IMDC poor NKTR-XXX Yervoy in X as previously by to we'll patients XXX PD-LX RCC. Yervoy will risk OPDIVO enroll compared with and status. with trial in scores and OPDIVO will Phase with evaluate

OPDIVO a TKI metastatic NKTR-XXX cell RCC risk a study, TKI will TKI with determine RCC with third TKI combination clear plus trial a of in will plus dose untreated be regimen inclusive to component compared the patients The then evaluate Nivo in The registrational IMDC will and for part a all and levels. to overall which the second read-in include safety and PFS study the ORR, with survival.

patients over NKTR-XXX convert whose of have we've expressers. that you As plus with baseline know, tumors a XX% positive expression treatment demonstrated negative can to PD-LX PD-LX OPDIVO

NKTR-XXX OPDIVO in This IR doublet the also as monotherapy believe a types. NKTR-XXX. plus of We standard that preferred is many with X we this promise deliver tumor of our why different trial of regimen first on the in Phase becoming observe conversion -- can I-O care NKTR-XXX

with working bladder NKTR-XXX negative into unmet of first our bladder program be a those PD-LX population particularly also with bladder, cancer in other single are In on to ineligible PD-LX the example, cancer the disease planning approval need, With baseline trial disease. very and As mind, metastatic our first-line focus with we're agent incorporate registrational we patients will gain to bladder in are from patients this and no of disadvantage a registrational CIS first settings. at high inhibitors are for will observed checkpoint in negative a cancer strategy PD-LX baseline cancer. in bladder cisplatin-ineligible baseline standard care. preferred patients longer negative on whom patients

of over a are design reference and the include study arm comparator this input with from study. into enroll XXX the will patients the we finalizing chemotherapy to trial currently planning are We FDA. The

the within month. clinicaltrials.gov trial this posted see on next You'll design

cancers January diagnosed with and second cancer. plan in XXXX, start muscle-invasive newly be will conducted in patients in The bladder Phase to bladder trial X

patient CIS ineligible. will both where the first-line cancer and bladder in metastatic metastatic in eligible trial be populations third The CIS

As that which PIVOT are following pathway of in has limited earlier, population inhibitor serve chemotherapy Howard registrational an expansion faster options relapsed second-line expanding with and chemotherapy their in patient appropriate cell as checkpoint design arm stated envisions could first-line. who patients the with received cancer disease potentially population, to a cohort enroll in in non-small inhibitor PIVOT a the this progressed, once an checkpoint we original has XXX approximately The lung first-line.

end, As to X continuing Howard we the focused designing clinical reviewed. on development trials plan now the stated, of advance Nektar just I are beyond our highly that are broad that BMS joint and to next wave and

communicated, different models, TAK-XXX. was dual reduce also advancing known cells developed a Howard of in NKTR-XXX myeloid-derived already the the lymphoma TAX-XXX NKTR-XXX a In Since suppressor in unique As Phase are target compounds TAK-XXX by this TAK-XXX populations, TAK-XXX we increase macrophages and microenvironment. non-Hodgkin levels is non-overlapping highly into non-Hodgkin inhibitor and has with end proinflammatory trial the clinical mechanism year. and lymphoma. Takeda's pre-clinical, SYK/FLT tumor clinical MX Takeda shown that X-X the compound of cell as shown before levels tumor complementary a clinical provide two stage of in the to activity to

NKTR-XXX a part three who will no and As I'd expect clinical at with early year we the liquid us. hand With trial than of setting, finalize to treatments the first Gil. in trial we refractory for trial in of prior in relapsed patients refractory first that have to tumor first over or With lines strategic this patients with melanoma, prior like the designing design enroll first entinostat this but combination provides call with trial before in update, the to and the of are XXXX. XXXX. more least the with patients we the dosed start expect of NKTR-XXX I-O end therapies, two relapsed Syndax, opportunity to The to study a

Gil Labrucherie

financial September the revenue $XX.X and for $X.XX the significant start in XXXX. a the quarter ended closed that million billion financial ended Bristol-Myers of revenue XX, third results, we and for the ended last of I and Squibb compared compared XXXX highlights Mary million R&D $XXX.X billion brief and for will you, good quarter. will in guidance. quarter expense XXXX nine for quarter XXXX for as million third our for $XXX.X first was million Total QX $XXX.X XXXX Thank months XX, for third afternoon, months nine at September came $XXX third of the in a million with the nine XXXX XXXX. $X $XXX.X with collaboration million then to million the review I of first months XXXX cash This to increase months We of Nektar's everyone. nine and XXXX quarter review the the quarter of is of and and result $XX.X investments. for

registrational to expect to continue the joint expense We our R&D execute on months. plan BMS with development over as we a increase coming

synergistic It in BioXcel, cap. trials expense in mind to XX, mechanisms keep cancer $XXX.X XXXX of In net multiple for net and with will funding will R&D addition, million ended that of months loss of with limit and months GAAP million third million trial million annual of our multiple Syndax, $XX.X will to various for important $XX.X as with but subject our to and Takeda, $XX.X trials XX, prior $XXX in We for compared obligation net we for limit income is funding funding to commercialization annual be the the nine income loss Bristol initiating the our September our tumor annual the NKTR-XXX obligation aggregate of R&D the combining settings, Vaccibody quarter NKTR-XXX. not with other recognition, XXXX, annual to quarter, types. This Pfizer a including a million September million is recognized cash $XXX ended net nine XXXX. a cap of

Now financial let's our to XXXX turn guidance.

unchanged. is guidance financial Our

other $X.XXX to of at revenue additional million remains and recognized million includes $XXX upfront the guidance $X.XXX billion, royalties $X.XX an revenue product $XXX equity and of the a BMS to from revenue. investment billion of QX which in portion and payment, billion year full sales, Our collaboration

unchanged. expense Our remains GAAP guidance also

depreciation million, to which projected and G&A $XX non-cash includes compensation approximately still million expense $XXX and We between non-cash stock includes of range to compensation continue expense. which XXXX XXXX is expense. expect expense stock $XX and between depreciation $XX million $XXX of and be $XX million for million, R&D to million

We open continue with between billion. for the And $X.XXX estimate XXXX a billion call cash we to I that, questions. $X.X end with that will position and will Operator?

Operator

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

line is open. Your

Chris Shibutani

past you potential Great, potentially in and cohort much. updates appreciate to you in I programs, to particularly thank a We X, an you're the Phase very taking seeking believe have of the strategy then and an the approval. study. about interesting for talked be the how single-arm the study about an you're study. with the hear it's better for lung, thoughts perhaps the randomized lung get for doing in of about when the earlier expansion the that regard path on see on this Can accelerated we in a based obviously path on and be patients would you the of with have that accelerated what And already sense a able might be confirm enrolled are might data thinking group to event your been in that the terms wouldn't

lung. have I who've data you trial some industry think path have plans to a pivotal competitors randomized Thank in updated much. some that regulatory we had and so involves other take declared for

Dr. Mary Tagliaferri

it's question. for Chris Hi, your Thanks Mary.

new at ASCO this both walked cohort of non-small with we chemotherapy, the with checkpoint as cohort. as in we discussion FDA, address chemotherapy did this starting that patients, second-line is patients not relapsed that's the in a year, new to treated checkpoint saw we you to the early are So these three one and a that have that did, began regimen previously cohort, and enrolling third-line was, in non-small cancer from PIVOT-XX cancer with been to that cell data that the cohort second-line a on and Dr. through about and original your in XXX we lung third-line patients KEYNOTE-XXX. a cell had that inhibitor includes cohort first go we you discussion the present we second-line, cases cohort and and now same have prior did this at Based know, when part administered cohort patients FDA lung our a inhibitor. saw that Gettinger question, the just we just in Through least

cell the the To anticipate in as checkpoint patients is both have inhibitors shared at that patient address for chemotherapy. this of first-line first-line I to randomized in touches have for the plans on we six as you roughly FDA. in wave patients of and months. program for have growing over the relapsed in with months setting, potentially we and are Do First your that this already randomized And in trials before chemo trials, time then next trials, the we chemo-sparing mentioned, prior question enrolling about XX Howard the then in as follow we on of data a we second combinations cohort regimens setting randomized the these setting very do both and also trial we I who early and includes clinical at to looking process developing present cancer broad next non-small lung we've well setting. later mean with that

us and consideration well plus for X at under who are is and in also are who those as nivolumab patients of who addition, setting. the looking unresectable NKTR-XXX Stage at as resectable, adjuvant combination are Stage In at looking XB, patients the XA

Chris Shibutani

see experience more experience with sure denominator that presented is XXXX fair of past that upon me. patients, update patients, last the sort some to assume the than XXXX ASCO I'm to that that months a during setting? specifically not with data and lung expansion then patients. and an months, can the expect looking with I the with XX have had you to then with perhaps the cohort, anecdotal from be, be And with data that realized is for that able isn't we number moving more it opportunity patients during realistic you year then, that guess the the but at what looking, SITC might can it, maybe I lung forward forward tell looking you're we perhaps XX So X dozen XXXX, additional we and patients would as

Dr. Mary Tagliaferri

short make I'm you very XXXX, simple, that going yes. to data see and to In the lung PIVOT-XX. from expect answer can

Operator

Thank you.

question BTIG. Robert from comes from next Hazlett Our

line Your open. is

Robert Hazlett

some and you thank data, Thank beginning collaborations One dose. about could that's high to in to Takeda with good in guess dose already with quick potential carcinoma, I that's other and Syndax in intriguing combinations entinostat, you are the for and obviously the My one, you IL-X, but hear is NKTR-XXX, went comprehensive Thanks. it's there to cell collaboration, the you also data why the talk and regard question entinostat you is index renal melanoma? toward update. thought how regard the with to with not settings about is

Dr. Jonathan Zalevsky

Hey, Zalevsky. the This for Jonathan Bert, you thank is question.

definitely, of tumor dosed proportion system. when cytokine we are of things in where the the two we So data the was, we carcinoma. renal aware how come were very drug collaboration the the that the yeah, mouse where of synergy of we we're range into work a both And that when into And of then the entinostat two together. and drugs the in different might we mechanisms earliest was underlying each high high microenvironment with Syndax what detected went high-dose together very cells, into a discovered very address initial to syngeneic IL-X one altogether. same study cell started immune dosed together, from and call, effector models reasons of one tumor actually That with pre-clinical discussions, mechanisms we program, the from those that our a substantial

cytokines. other means, that immune this like high So TNF end, interferon and were effector kinds gamma, very specifically, of cells

because kinds of look cells mechanisms. cells certain setting, And those kind the kind overcome so the especially the then to in of particular, was relapsed/refractory that resistance of that impetus can are into,

the targeting a relapsed/refractory then clinical became So attractive trial. that of why And molecules. utilization melanoma we the setting type into very two the is prioritized tumor this

Robert Hazlett

might of Bristol-Myers, data Thank these when you call any see it's just you. beyond general And let's first one them, other a then just other Thanks. or studies? then Takeda And we biomarkers or collaborations for any the whether Are in Syndax these, using any question, follow-up. of ones? our

Dr. Jonathan Zalevsky

sure. Yeah,

extensive an these because be will new mechanisms. now program, there definitely biomarker are yeah So

to And we of into clinical that mechanism-specific Syndax both there, done always the NKTR-XXX, under of combining in that that the working way. also in and so the complementary for we're trials, that trials second, that biomarkers the all species where will a way. they're program. address together since both the independently collaboration, in We things likewise, the pre-clinical yeah, the we Takeda well And there in to in two the want with data checkpoint, just human PIVOT and we're because they're XXX we're employing are a are plus as running mechanisms that and next these and doing did as presentations then, the synergistic just in working lot we've getting NKTR-XXX REVEAL, translate and setting. to year, learn the We're collaboration that like be

trials those presentation both data of as So the on working program closely Takeda what the we'll for be and with program on from mature. dates is, doing Syndax that they on Takeda

Operator

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

Your open. is line

Tyler Van Buren

the that Great, morning going had the just and was thanks good released on couple on guys weekend. clarifying yesterday into the abstract a of questions I presentation evening.

Friday guess those patients, not yet? at scan a they enrolled well from patients that Or and I patients of valuable ASCO received just not patients, and we XX expect and a evening? the as or XX should saw for response XX at the time cut-off. they data we were why were number three valuable Firstly, there were XX patients had Were

Jennifer Ruddock

not very the XX Yes, update during will patients patients we in did for were question, the much included the and for asking and have thank not why provide patients were reason presentation. Dr. the you Diab's those not those certainly three scan three valuable, a Tyler,

we response independent addition, our the be very updating will objective the and per PIVOT We radiology. review into unique independent providing as something in be we radiology confirmed response rate, In we program, did will rate study. embedded objective

disease would as plus control we tolerability Howard to of forward the And complete you continue rate nivolumab mentioned, and as information NKTR-XXX well profile with presented be to as we of share at so SITC. that all Dr. new look and you rate by will seeing also response Diab, the

Tyler Van Buren

those many assess the I'm didn't go XX second non-responders? didn't we how the cut-off to How of XX respond of responded had of abstract trying I guess, so scan update potentially those into one And us you respond the XX helpful. a XX, of guess evening. tell and Could respond that's many as as Thanks, or could yet. on scan, I Friday

Jennifer Ruddock

Yes. Thanks, Tyler.

you me to the days the share all presents data certainly over at happy enrolled present you oral questions cohort, two we're next presentation. his to this very with the happy in answer just patients Diab presentation. Dr. we're Let when X to following his months And that follow-up the median to in just and is SITC for

forward look So we you there. to seeing

Tyler Van Buren

the cohort, I was have Okay, I PIVOT guess, enroll of wonderful. based sometime the the renal bladder the expecting just if we well being expect, GU. as population not did surprised from renal saw half that data behind? I get or presented cell, quicker cohort And lack little efficacy be before cell accurately this we'll much see in PD-Xs upon at given just PIVOT guess, a or first I cut-off guess, bit that the in of update to we is, far cohort last the I the bladder the should ASCO

Jennifer Ruddock

cell definitely before, carcinoma far shared shared respond melanoma with as months being patients previously in the we we've think in data the after behind not we've I with tumor responses different, we've to occur both see as bladder. seen can we you out you some expect some bladder. XX renal you renal and types, Yes, as And rapidly the be carcinoma, all And very cell in treatment. on seen in way

wanted bladder to yes, for cell to cohort presenting be allow so renal will GU and at mature data the ASCO the cell soon And we and renal we thereafter. carcinoma,

Operator

you. Thank

from next Our Jessica JPMorgan. comes from question Fye

line open. is Your

Jessica Fye

taking questions. my Hi for thanks more guys, for you. Mary, a got I've couple

to rate you some as melanoma I-O benchmark data mature, the about range, first-line like cohort complete going in it at have relates were to the and combinations maturity saw to us seems other in the the looked compare matters into XX% but they And CR you talked of of what rate. it we're here. shown I'm it heading You see more curious, in non-melanoma just could kind for set the I the that SITC. updated if response

and I as got So a view what you would lung. on couple compelling on CR the rate

Dr. Mary Tagliaferri

for you Yes. that asking Thank question.

rate James I the if comparison So you'll around you going be of our follow-up Journal New at same median I to that is a XXX follow-up the just that pull apples-to-apples is the Lancet single-agent complete time CheckMate this then just then you was just that at at was what X.X%. months. than Nivo up it Oncology. follow X-year much paper, Ipi was XX in to just the median that mentioned England had study is over And Plus at response follow-up it And time. Medicine look manuscript, the and XX.X%, X which see that saw And over when for was think you Larkin, you the months, look nivolumab, lower published median if look XXXX in the in

present I fair SITC. to at that the data to the that's benchmark think going So we're that

Jessica Fye

to non-small added a starting press reference out. a several to else make I starting the laying release, sure next Phase trial was patient one want months. also tumor for that just as another understand, referring the in you've that that several XXX in the thanks of mentioned X in or the cell months? PIVOT like cohort with Okay, to to types lung Was second-line up it I something

Dr. Mary Tagliaferri

yes easy, question. these like I

that in the have patient the refers cohort the, that So non-small cancer, is, answer XXX PIVOT. second-line we to cell lung yes, but

Jessica Fye

when that And question you go what updates following Chris' 'XX? And kind as bring to we'll Or might imagine, XX a at think ASCO? second-line, single-agent mostly you can into so population of across of FDA? not that data post-XXX And we're need up then PD-X sort post what the to standpoint analysis a from the in I'm data going a just data that from regimen later. in it this read enrolled I'm investors third-line, probably if on progressed report hit chemo going the in Fleming on, And think that, of you it those to as population about assuming cannot little Okay. you once about also to a lung built threshold? get Will plus is in data we had can first-line, patients, see curious show you patients and XXXX, in and disclose that from comes on who to what from there that cohort see do is maybe along. that you all you you might PD-X

Dr. Mary Tagliaferri

repeatedly, Yeah, looking we as data. additional we data present in we'll and XXXX. mature, in said we the data the to this cohorts present high. to be the present population, definitely plan addition And lung PD-LX, low, these will to in the also both And medium relapsed/refractory first-line, the

we of for two different both So those have cohorts. plans

small we've cohort. and I I population that think accelerated the pathway for second-line with and been population PIVOT-XX pure the one in mixed, that the difference highlighted is cancer to cell the lung potential again, moved we've has a second-line cohort is, approval, lung been third-line a non-small just cell enrolling to cancer,

Jessica Fye

to accelerated do the need that XXX to would just approval? what secure last in second-line you And cohort show patient you one, an Okay. pure think

Dr. Mary Tagliaferri

compelling response that highly a on sense in Yeah, at in to record be population for went rate. second-line and about of a makes has ASCO, Dr. Scott when response a would that the approval, lot say rate Gettinger think of XX% roughly you X% accelerated docetaxel

with We and are gather have regarding dialog more engaged in we forward cohort. having agency the an strategy our FDA move we ongoing this data the as and

Operator

Thank you.

Our Difei next question Mizuho from Securities. comes Yang from

open. Your line is

Difei Yang

my afternoon Hi, good and questions. for thanks taking

a couple here. So just

which a from in ongoing this seen starting decision planning registrational trials. BMS? number the Sounding you allows are of PIVOT, make have assume PIVOT with data of studies Can we phase joined to you like you the

Dr. Mary Tagliaferri

decision reviewing we BMS and the we have. with analyzing registrational the where into data to and We've the been have as trials these that. been we advancing Yeah, on are been data trial based and making from PIVOT-XX see jointly signals

Difei Yang

a decision? there efficacy get the to pre-determined Was threshold for to

Dr. Mary Tagliaferri

registrational underserved need. by looking in are forward is cohorts broad with opportunities patients melanoma, where to We've at trials and warrant the decision biomarkers, So, a patient inhibitors. landscape We've as at checkpoint a those high response upon move our a looking, see from trial we seen disease our and standard safety registrational PD-LX look last, been negative into where early is populations have the to data populations, we've and compelling We've we of of at looked care. data, where have been to populations where we rates forward unmet our moving at course, improve in our looking such both patient there multi-factorial. medical competitive

Difei Yang

Thank Okay. a additional financial color. then question. And that you, for Mary

Pfizer collaboration the Takeda, to regards with with on the spending perspective is from Nektar? and So R&D the et commitment what financial cetera

Howard Robin

that pleased Look make clearly, Pfizer would conditions Yes. will I the tell collaboration. question. that, that disclose try financial This is we Thanks Howard. prefer the of been, don't we you we had for to to these other the we've very what to done be together us with collaborations contributing cost similar ones those trials Pfizer. and we're doing of with we're will both that and of clinical

Operator

Thank you.

Our next Bloomberg Intelligence. from Goonewardene question Asthika comes from

line Your is open.

Asthika Goonewardene

to RCC call you Nektar And subgroups. in it's relapsed/refractory the be going to good study, melanoma and had populations Hi mainly thanks enrolled guys, for about questions. and the I'm you'd my the here, taking PIVOT-XX in in first the that query now. patient

and melanoma You you XX at about on XX to, some data this, when patients RCC enrolled ASCO. I'd XX, releasing in plan had patient about these like patients relapsed/refractory groups?

Dr. Mary Tagliaferri

this well. Yes. We on as our said last call

X investigator from next XX the moving XX months, Phase X stream we can we it's feel as PIVOT-XX strategically have when of tumor-specific months up in conferences ongoing show course to a run conferences strategically, into as plan important of to the like and and to an Over to trial large months meetings. forward we're well data

publication ongoing So XX an months have to over on data release broad months. we next the very X to strategy a basis

to patient comment on to relapsed/refractory approach you we population NKTR-XXX relapsed/refractory also And our are and so to moving toll-like with combining over like Jonathan that we in agonist. In population. forward in receptor are addition, also with Zalevsky know, turn patient as this I'd the our

Dr. Jonathan Zalevsky

when of were much a Yes. key regimen. pre-clinical immuno-oncology we earlier know Mary regimen. our of in plus resistance making context learn successful NKTR-XXX that's could kind that one it NKTR-XXX we the mechanisms, overcome other any to of point lot about of kind very Thank doublet we setting overcoming developing in feature that, I end, And that, of to I-O evaluating things was was that on anti-tumor and limitations you, that focusing is began clinical earlier this in relapsed/refractory really And populations. year really study to an immune a REVEAL patient the a that NKTR-XXX the

patients relapsed/refractory rolling across a tumor range types. were there different so of And

this And so and weekend. of administration presenting NKTR-XXX that we're trial, also immune very systemic pleased into later system, innate that really NKTR-XXX able draw we tumor early will of be is What intratumoral in mechanism the results and coming of how cells impact of then up some with to the can we're the the combination see immune immune innate drive responses.

data to investigation additional And we'll continue presenting we the of addition well update. both agents. those that also as So as clinical two our pre-clinical in be

Asthika Goonewardene

how me you to you remind define relapsed could and And Okay. PD-X? refractory

Dr. Jonathan Zalevsky

Yeah. Sure.

Dr. Mary Tagliaferri

Yeah.

this, criteria in enrolling eligibility that prior and inhibitor NKTR-XXX NKTR-XXX has before we in on prior scanned these melanoma patient are our applies plus who, the example, same the our protocol, on checkpoint So the according progressed two show and for progressed program. PIVOT-XX been have patients and to a patients treating on

Operator

next Instructions] Blair. from you. question Andy William our Thank And [Operator comes Hsieh from

line Your open. is

Andy Hsieh

started planning or question. this be pivotal Great, trials thanks either for has will phase. RCC for and do Mary taking to my my Again, the question the three that's with under

trial. ORR, endpoints, one reason you including that has because just And is share obviously terms the wondering is do arm, of an was. rationale think, three the the comparator behind you, in in are endpoint wondering more would the what first including related and which actually the as of not that, pegaptanib But of that include first market [indiscernible], from those one of if So with standard split RCC obviously setting. care. that, the co-primary just of front-line in approvable power a I'm to RCC I used two perspective, the to

the trial? that why wasn't wondering included So really in agent

Dr. Mary Tagliaferri

Andy, Thanks question. Mary. Yeah, your hi it's for

to the proportion include of the when our ORR. alpha, So label, in response you do rate, results a of allows only when the it small split your and very you allocated objective comparison from you your that, we've alpha to

bring MD So study. of room sutent TKI you'll Tannir why did just United could oncologists X as bunch oncologists countries led GU which included community and and in bring the to and choice. this And GU one TKIs then the the their together a a recommendation Dr. of from the in States, clarify the that's of that. Anderson, used input trial, committee in global folks is We is these by of to in you going oncology was commonly a varying steering of the from outside have

Andy Hsieh

you discuss great. is Yeah, that totally dealer's lot be obviously trial think That there. one Related I-O of is how sense. the talked out a TKI. inclusive makes of third to chosen, about choice that a you Did which it. that I Got TKI combination the will there that, is that's is

little matures now it's right So over a used be that as to time. bit harder foresee what will market more

Dr. Mary Tagliaferri

Yes.

So the trial and following part that we'll which as in decision X of TKI in to part this we than to forward at of Phase the pivotal make registrational into one study, take a X the looking the are part X study. actually more Phase

Operator

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

Howard Robin

to incredible developing thank this of to that always, the progress joining employees you for you And look we us SITC. Nektar diseases. I And Well, thank as seeing in made to treat afternoon. devastating all medicines want at everyone for the forward they've

So very much. you thank

Operator

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

Nektar Therapeutics (NKTR) 7 Nov 182018 Q3 Earnings call transcript