NKTR - Earnings call transcript Q4 2019

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Nektar Therapeutics Fourth Quarter 2019 Financial Results Conference. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Ms. Jennifer Ruddock, Head of Corporate Affairs. Ma'am, you may begin.

Jennifer Ruddock

Crystal. you, Thank and everyone, for us joining Good thank today. afternoon, you Howard With Dr. and Robin, CEO; are Gil CFO; President and our us COO Labrucherie, our Zalevsky, Dr. R&D Head Jonathan our of and Head our Wei Development. Lin, of authority our to the plans at On today's including actions trial certain therapeutic medical regulatory for trials, meetings, timing results, future forward-looking for clinical of regarding plans future and statements our the clinical other for financial make future drug and timing decisions, call, and our guidance business, statements clinical health business. of candidates, expect outcomes we plans and data potential presentations and regarding of these statements control. inherent difficult to that Because subject are to outside relate to predict they of our are and many risks future, uncertainties and the are which forth and our filed is uncertainties that we XXXX, set November sec.gov. available at risks XX-Q are on Form X, which in Important obligation no new undertake whether of these of result We a developments update as to otherwise. future statements, information, any or this available will of A be nektar.com. IR on page Nektar's at webcast call at website the

I hand CEO, the and to President our Howard? Robin. Howard now that, will call over With

Howard Robin

an you, on which and pipeline Thank candidates and Nektar everyone NKTR-XXX. call provide program today. pipeline you for our On IL-X, Jennifer, today's to and include will we our on TLR agonist us compounds, call, joining thank IO IL-XX the of update our immunology

our that the with of before immunology discuss milestones faced to core programs and NKTR-XXX. year are provide and like cover I guidance we our these Starting XXXX. of planned the for challenges will briefly also review But upcoming outside we I'd focus our We our financial made this pipeline. portfolio, for some IO advancements with

higher were NKTR-XXX. opioid was decision for we NDA negative approval any made clear for to compound class, NKTR-XXX of by it much discussions opioid that several what became a past. the from approvals the was in ADCOM As than established The month and that that the last is week the these bar of you the know, strategic withdraw first for

a in NDA, significant consideration our with Additionally, become since we of liability medicine not this that that investment class, could opioid factors, upon which in our time further manufacturers has we important been for and class for expense at of based justified opioid submitted would the filed be these decision business the numerous have immuno-oncology made developmental against lawsuits work distributors. And all that pipeline. a sacrificing the

successful development we As this efforts program. our look at back for

thank their focus in pipeline. the this the did work, whom our I immunology our who came of want it is take to IO for participated to some as our we clinical hard action speak trials, the believe lightly, team on but not thank to advancement and at and decision appropriate take physicians the of patients We ADCOM.

based chemotherapy we survival in the physician's as cancer ONZEALD the patients partnership advanced standard subset have brain as And that of choice. endpoint in from of OS, study ATTAIN upon ATTAIN know, The which you to also earlier patients BEACON compared was ONZEALD the and at physician's chemotherapy primary performed as ATTAIN And to our study a Secondly, of was being as PFS study well care The in a in study for breast mets ATTAIN improvement the of funded overall least choice compared the Sankyo. of while met. ONZEALD, of not were week. completed brain saw with we metastases, late former patients. last study in choice for analysis study cancer designed Daiichi agent, a of had advanced breast agent from recall we conducting a these was of you'll partially that who chemo ONZEALD the survival doubling with was patients

to the their grateful further no and the families study. planning participated we're in who result, a patients work ATTAIN As and we're ONZEALD, clinical on

With where of have immunology, immuno-oncology believe focused in highly the and we company core areas these patients. is actions transformative we medicines the us, for potential behind our to create

two IL-XX molecule cytokine tumors. NKTR-XXX about which and TLR IL-X conditions, differentiated to with strong with liquid and programs, In clinical talk more a and Our call. atopic This is first allows advancing BEMPEG multiple small those dermatitis capture several and that on and IO span portfolio into NTKR-XXX in the the agonist portfolio psoriasis, of highly lupus, I'll unique immunology, opportunities autoimmune studies later both is solid with our us program.

in this Registrational we the Let Programs partner, T new to lung way studies the adjuvant BMS, more cell in me upon first-line Registrational for melanoma, collaboration cell cell and of with adds development active cancer for types the year, tumor and patients. we our seven Nektar non-small revised agreement than a in first new start with also carcinoma, under plan, doublet across with four from now IL-X the NIVO three II studies opportunity Program builds in include line bladder joint pathway cancer. and announced plans BEMPEG a and stimulator. our study under Phase were that program settings, BEMPEG, renal Earlier expanded first The the BMS, X,XXX

launched metastatic III already RCC, the cancer, a we in study Registrational metastatic addition three new bladder Trials initiating In we've and III cancer study Phase to in metastatic melanoma, ongoing adjuvant and a cis-ineligible are bladder Phase first-line muscle-invasive in first-line first-line melanoma.

for enhancements clinical let plan in payment the the which the share the will collaboration. economics for seven initiation The QX some milestone million a also of the III of you for also it studies, revised we of year Wei a in joint at associated new occur It we studies MIBC BMS's approximately design these a additional Nektar, the payments. the commitment received to billion. which a At the There with continued were expect development to Phase economics the at high $XX Nektar if QX is with milestone I of new BMS's and accelerated start that near-term of $X.X this year. of moment. of melanoma cover costs includes milestone adjuvant new provide this million accelerated reflect includes level, agreement study, look will $XX study. This in the

new with $XXX indications In three BEMPEG. is cancer for BEMPEG of $XXX of milestone payment each of total X/X and XX% million development XX% The approvals addition, Nektar the The BMS. in Registrational economics then in lung start III We're Nektar entitled and cost, million NIVO. X/X. study million at non-small BMS the global payments Nektar, also cell first upon Japan, books the includes milestone to funds rest the agreement revenues. per of accelerated $XX unchanged. Phase of first are the profit the Europe split's U.S., approved the next to contributes

enrolling our patients and Registrational As you Trial all metastatic investigator are sites running. melanoma, of is first-line know. in many and currently now the in BMS up

breakthrough projected plus study. metastatic we NIVO could with has in therapy roughly endpoints, the the this change. the XXXX obtained based seven a FDA endpoint this in occur The three ORR required endpoint of response study time follow-up is OS. designation event-driven, patients for year, reaching for enrolling this Phase and complete needed the QX the on six ORR, an is the for positive is line later. reminder, end to on our projected earliest timing months to melanoma, current time including from interim number III PIVOT-XX setting data, BEMPEG and patients The Last rate The PFS But first of year. period PFS as

For both OOR and by be PFS, radiology review. analyzed will results the blinded independent

completion for this mind So will also in the timing process that of affect data analysis. keep any

the XXXX. So data first most likely will readout QX be of

able should this line. we closer, As we time to head be refine

an the a ORR As full of approval endpoint. and We approval is reminder, a is accelerated amount spent designed small endpoint. this, PFS on alpha as only

excited designation, efforts doublet for in and promising. the adjuvant setting. the to agreement patients potentially our part from is melanoma two essentially the that this melanoma of BMS, the of opportunity breakthrough companies BEMPEG. the our potential expand With development our benefit doubles for represents melanoma number in with could doublet significant into as This amended And a quite are

further position leadership study melanoma, In cancer, is and lines across pathway to in nivolumab first-line therapy potential early both support stage accelerated nivolumab bladder that a in a advanced cist-ineligible which with intended care to approval in all cancer, pleased the of we BEMPEG Given has potential bladder of advance BMS with XXX-patient has enrolling the are the we're in standard melanoma. setting. this

Specifically a in patients by CPS as with defined score PD-LX expression low XX. under

to of initiated and muscle-invasive positions BEMPEG a We doublet expect ORR cancer, and capture late-stage us and bladder on chosen the the cell expanding even confirmatory data Nektar potential with first-line QX trial metastatic in and from patients cancer, cancer. NIVO patients. in the QX help XXXX Phase or a BMS regimen. build to this the the this a for ability opportunity III In bladder more and both renal also comprehensive a bladder to first early sparing study cist-ineligible TKI gives approach inclusive we've that TKI carcinoma, the opportunity in This endpoint have potential with in on

first-line and have Registrational triplet. regimen to TKI new XXXX. we readout a the now RCC Registrational versus interim metastatic the to with study work path will support agreement designed development Phase of the inclusive and track a are start this in The III a OS under Our BEMPEG first Study NIVO is is in first-line enrolling quarter TKI potentially BMS evaluating mid-year forward RCC and and on nicely, first

schedule NIVO first-line We and with establish administration will axi evaluate Phase and plus future the combination expansion escalation conduct study a RCC to to BEMPEG in Registrational I/II dose dose Trial. in for

path BEMPEG those for agreed cell and trial, in BMS Registrational other in appropriate cancer. exclusivity work in that in evaluate the neck and optimization cell exploring continue place expansion cancer. of Phase or development list BEMPEG of program. and us evaluating enhanced us pembro forward have Nektar cancer in us and and for study cancer patients. for phase for PROPEL cell is flexibility agreement this with run path the to flexible that collaboration. to NIVO the enrolling agreement the renewed lung currently Ib/II for and a we this pursue we future our BMS In identify And first XXX% on with Finally, indications potential dose work forward key lung role in we're with positions a believe study moving the BEMPEG in from pembro certain for of year. This cancer. look of cost non-small other removes BEMPEG the regimen, lung also our collaboration the which checkpoint a BMS will non-small have to forward to is cancer lines, ongoing flexibility and non-small with gives this our doublet non-small dose combinations prostate nicely a paying of will either head an castration-resistant inhibitors mechanisms expanding a and BEMPEG. Along and Pfizer, we is cell pleased structure This lung old provides so other to the in restrictions line We're

The talazoparib in these tumors. and evaluate plus study combinations, Pfizer and two solid BEMPEG very head tumor this neck settings evaluate PD-LX We're BEMPEG prostate for in and to enzalutamide and nivolumab on in particularly two BEMPEG, because with in negative BEMPEG work of cancer. cancer triplet and and excited avelumab with opportunity also patients plus will avelumab the

this We with Vaccibody. treatment with a tumor pave BEMPEG regimen could in cancer approach and partnership combines with head BEMPEG personalized their also in for study started vaccine setting. novel a way in and the study neck The

to start have addition, molecule, Pfizer, with pancreatic and combining BEMPEG, cancer. In plans in study their a avelumab, BioXcel, we

agent see, about As excited the programs is can with largest one the potential development combine as emerging checkpoints of we're novel and the to and program of immuno-oncology, other in mechanisms. you this BEMPEG and Registrational

our Turning BEMPEG. next NKTR-XXX candidate, advancing, Phase study of recommended TLRX/X immuno-oncology REVEAL achieved to our we II and Phase recently our I/II our dose NKTR-XXX, is agonist, with

NKTR-XXX. this because a microenvironment high PK/PD to allows to of dose was had escalation then levels in safety escalation. tumor the characterize understand that and combination, BEMPEG and We've novel-novel evaluate NKTR-XXX we of staged recall You'll activation and for us dose observed the dosing with TLR

Phase plan one immune system type, of the now least biology the explore combination's simultaneous at focused current potential in a II relapsed/refractory melanoma evaluate to in TLR the the in of BEMPEG and Based upon dosing dose expansion IO take to melanoma patients. innate and refractory is with adaptive XX will setting. of NKTR-XXX Our recommended into relapsed we starting interaction, the the tumor

to beginning natural generating treatment And of cell is recognize killer scientific in you The know, importance excitement. many of the as cancer. community much of this the of research biology area is

cells NKTR-XXX NKTR-XXX. of candidate, the NK cause proliferation clinical us pathways which development both known So memory newest our the cells, full IL-XX as expansion let me agonist wide CDX for of pathway program designed potential to a of to biology provides is now the range our and turn IL-XX of with to capture NTKR-XXX.

product profile, will forward provide emerging fronts program this from provide a we're on details but on Given with the overview more this multiple this program, progress high-level toward and mechanism. of advancing the me promising let data the on JZ

first-in-human year. XXX, study into in first which lymphoma, The or clinical monotherapy, non-Hodgkin's patients combination trial then in evaluating NKTR began our dara enrolling XXX, NKTR last we're respectively. as First, and rituximab is a and with multiple myeloma of

we addition, research collaborations two with partners funding research. have who ongoing entirely the In are

NKTR-XXX potential internal studies of mechanisms. combination is of a Janssen combination in nonhuman their Gilead primate number portfolio. a exploring of antivirals in studies, of virology, with the number their And preclinical oncology separately, in in First, conducting NKTR-XXX, in with is

many So virology, potential we as to well and potentially, NKTR-XXX the in has look to its as, applications forward oncology progress. have

program, to on reported progress Lilly. Treg our with XXXX in program is NKTR-XXX, significant We Moving with stimulatory partnered year. last this which

the year's Phase patients, Ib be candidate's these and dose-dependent volunteers selected EULAR healthy at to proliferation ascending recently this have dose lupus reported data the First were EULAR, cells. at and meeting. submitted Treg multiple demonstrated in We study data completed data these presented the of in and we human

initiated partner, are autoimmune psoriasis Our recently atopic studies Ib indications also these in Lilly, and and two dermatitis, enrolling new patients. and ongoing of Phase studies

the study middle year, this this to to add Lilly, indication partner, another Phase they Phase in of in dose-ranging start Our lupus the year. plans to has and II autoimmune plan development a II program also

the novel mechanism very of treat commitment we're So and pleased this potential nature the with reflects diseases. of program, their to broad this which autoimmune development

study call And to III Wei? with Wei for Phase BEMPEG. that, to to turn I'd review like the over the design

Dr. Wei Lin

area like plan pathway I'd to IL-X been with setting. discuss validated. the developed already has Howard. BMS partner, we've where comprehensive in for melanoma the doublet you, An nivolumab Thank the briefly our plus the

As demonstrated especially greater its ASCO patients Howard study our melanoma by Based survival with XX% who patients a of had pivotal achieved lesions, central lesions deep median in worthy melanoma XX% significance their in data had had a greater complete a XX% approximately high hard metanalysis blinded likelihood having they responses in XX of association stated, At shrinkage presented month, metastatic designation XXX% recently as very determined FDA with the had been immunotherapy. a review. from and overall by RECIST targ progression-free they almost response have in or XX% we have NIVO. breakthrough generated metastatic in first-line XXXX. NPAC plus XX%, survival, independent at target improvement reduction a survival than a tumor patients greatest treated analysis, on in of a and follow-up of this reduction the of that achieved half, a if in and were including complete The lesions. response, II

agents. pivotal X/X response that data correlated patients melanoma or a in showing from in with is melanoma. II response confidence of our is doublet greater highly in IO context, definitely melanoma with the that survival the the With reinforces XX% nearly very study So our had

at this a We And follow-up, we in in reached. future from year. median presented half XXXX, at PFS XX been indeed, this updated the not approximately as share had data second to November cohort of plan months with meeting of SITC

This study that the post-surgical plus Our adjuvant that event evaluate confidence the melanoma with BEMPEG study, treatment in XX led be free to X,XXX months. of extended NIVO the initiate and in XXX to treatment may single-agent study endpoint will in estimate BEMPEG of the duration in BMS patients plus will BEMPEG enroll us a between we of the offer potential survival. has and clinical nivolumab. We patients benefit plus doublet an with compare will The NIVO a NIVO setting.

year. second We of potential half and expect expect XXXX. melanoma are readout in we the a Due in to long protocol the studies, the first finalizing with duration to of trial this start this adjuvant BMS

a Nektar III BEMPEG/NIVO now melanoma. BMS the patients with approach new Phase of more metastatic and transformative potential study, to doublet adjuvant have the ongoing the and to comprehensive With the study melanoma expanding

Phase addition, muscle-invasive BMS enrolling cancer patients new started as the in In setting. study, Howard January, disease III is the periadjuvant in with stated, which bladder

metastatic patients. carcinoma ongoing in Our cisplatin-ineligible patient the And essentially urothelial is study study in into new Phase earlier III population. this disease our same doublet for extends the

filing by stage potential the a planned approval our In will trial also addition, confirmatory patients one as stratify metastatic's will with ongoing accelerated status. study, and the serve the trial. for muscle-invasive PD-L In we study

for be presurgical adjuvant plus is receive patients be to BEMPEG same or treatment and new standard surgical no the current readout and longer the a event-free either cystectomy, The will phase, this which on our primary NIVO to pathologic into study XX-month continue expected treatment with will NIVO is they be at arms Then response period. first XXX or a potential pre will regimen of after XXXX. randomized endpoint survival. treatment in is the complete During Again, care. three all,

that, call to With hand to JZ discuss our program. the more I'll on NTKR-XXX

Dr. Jonathan Zalevsky

Thanks, little large it the program, NKTR that our the designed spend NKTR-XXX the pipeline the more was Wei. time IL-XX pathway. full is XXX, interest. generating like cytokine as program I'd biology to of significant to next discussing in capture is a IL-XX

targeting the pathway. meaning NKTR-XXX agonist that is to IL-XX available interactions receptor Specifically through ligand designed capture the all

cascade. promotes cells. is of a and and importance the survival natural killer as cells of community expander T NKTR-XXX clinical expansion memory that IO an cells NK research cells and functions agent recognizing the in of The increasingly As consequence, and a significant the memory CDX

mutant NKTR-XXX we of We it to bind all this beta to IL-XX I efficacy. to to forms the other only will stated, factor receptors. a in that development believe that gamma is have for engineered receptor just that versus bind enhanced translate proteins as Now differentiating key

cellular know native B For induce IL-XX. to XXXX B showed even intracellular order and granzyme muteins than that and other versus example, in data you we support that NK cell-mediated granzyme more get need at maximum production SITC we to killing, presented

preclinical we data candidate. highlights Additional generated various for date the this to opportunities combination

an an of to cytotoxicity worked ADCC that daratumumab see and we rituximab with such cellular combine through mechanism or antibodies action. First, opportunity as antibody-dependent

binding cell reaction, antibodies by with Fc NK via This called recognized antigen to opsonized then are is of cells. receptors via NK antibodies antibodies Fc the is able the and the of via targeted of of this cell recognizing These opsonize on build cells, the surface to the action of the Fc ADCC clustering the opsonization. region selectively NK In antibody. target the cells antigen cells the of portion killing receptors leading opsonized recognition The promotes the immune effector to In degranulation an a to process on opsonized buying cells. cells gamma gamma NK coating specifically, antibody way, of cells cells. the

the sustained increased mediated of in the in compartment. targeted treatment profound of ADCC marrow combination was function. cells, NKTR-XXX nonclinical If that NKTR-XXX limiting NK numbers in see of we promotes ADCC cells opsonized preclinical the the ADCC effect. NK and killing NK of and able proliferation of the efficacy is we daratumumab of antibody. provide with lymphoma enhanced are activity enhanced Consequently, one cells, limitations In antibodies, cell exhibited and model, cell However, tissue reaction. clearance single and bone combine reaction the are the and bone the and of in NKTR-XXX by NK marrow a effector agent cytotoxic in to to very In vivo ADCC function activity activation depleted cells can themselves actually tumor enhance cell the in proliferation antitumor daratumumab, consumed ineffective, substantially studies, where that that

of was donors study dose and enhanced result patients cells function tissue T blood peripheral for inhibitory was ADCC elotuzumab NKTR-XXX Collectively, study status very and lymphoma ASH, daratumumab both data but cell cells of manner. patients myeloma a effector is the it we'll increase including XXX, plan systemic, antibodies antitumor dependent a able study, NK myeloma to at this evaluating or our through effects. to recently of compartment, bone the memory the is as at because in number The daratumumab confirmed NKTR-XXX dose-dependent and showed strong that and NKTR from NK the is safety enroll generate to the can well The with in as to significantly mobilize NKTR-XXX expand the in and that the also CDX healthy cells multiple NK combination with also marrow rationale monotherapy, and revert effects status that showed provide with we and a of multiple able under More now susceptibility not a as these Now in with multiple that also myeloma. and work important into only synergy schedule for which with from evaluate first we NKTR-XXX of NK myeloma study. functional multiple mechanism, rituximab. populations clinical and relapsed an this non-Hodgkin's We activity. then refractory patients pharmacokinetic pharmacodynamic will way. indicating

biomarker CDX to evaluate their We survival. memory study mechanism will introduced NKTR-XXX a this provide on of a we subpopulations the T of effect also deep program and NK expansion, of total CDX and cells and into assessment activation cells, the Besides NKTR-XXX also to trial of action. have robust

early development This in clinical follow approach for planning biomarker development the allows the science us and rich XXX. to NKTR

of initial this from goal this phase the Our I Phase to achieve is first monotherapy year. results trial

In NKTR-XXX their addition, present respective as data preclinical and Gilead, with well. partners, Janssen our may from efforts

IL-XX adding with also promoting be response therapy. a more may we of other we NKTR-XXX is durable T for to able with very cells, of of in and potential short and period get relatively only memory CAR-T Now time. CAR-T therapies. duration cell CAR-T see a associated effective, but proliferation combination for much By

early collaboration some has impressive data Hutchinson Our with yielded also presented Fred at ASH.

of CDXX-targeted in and models growth CAR-T CAR-T lymphoma. increased when added cell survival researchers prevented B-cell to demonstrated NKTR-XXX a tumor of Specifically, regimen cells

Gil review the call of turn With a that to the financials. me over let for update,

Gil Labrucherie

for in BMS III year with our taking expect net to is studies expanded in in $XXX initiating $X million usage complete XXXX in to account to This billion as the a of investments. in to we the Thank million will earnings XXXX this $X.X guidance Phase On announced everyone. afternoon, are expect and good financial cash plan exited $XXX Starting XXXX million financial secured outstanding This plans cash cash our our in full the repay the notes in balance This balance After this the our melanoma, $XXX with as as Registrational operations, to improve in senior repay savings in our afternoon, primarily strong annual net we of usage billion debt of cell on cash release. and you, $XX year on our million sheet. with With cash will it go-forward decided our our position, our for million JZ, investments. new in approximately program position, to cash annual first-line result renal of and investment results flow to approximately XXXX. of XXXX. BEMPEG enrollment we collaboration. QX, a compares two cash we of in provide bladder, This begin press and XXXX. and for strengthen result well our interest carcinoma we for exceptionally increase use have call, annual cash development we $XXX under will end our sheet XXXX I approximately Studies of basis. With respect R&D

turning revenue. to Now

million Our GAAP this and expected agreement. expanded milestone revenue revenue be million includes from $XX under $XXX is year. and our $XXX accelerated GAAP new to payments of million between BMS

MIBC for of January of this million occurred currently milestone study, in QX. will $XX $XX of recognized adjuvant first which the start in second connection And million study, melanoma with for be The QX year. planned in the start which be the of the the is milestones these will

million following: million noncash XXXX the remaining four to to $XX $XX million outside of product we additional GAAP XXXX, $XX of which royalties, million, million cash anticipate Excluding and GAAP collaboration fairly to includes the comprised these to revenue, of R&D million quarters ratable $XX licensed depreciation of will in million $XX $XX noncash other $X the and to $XXX expense million BMS. expense. of approximately over milestones, $XX be sales revenue of and revenue an between $XX $XXX million million stock range compensation expect We $XX million royalty million in of

expense of expect four this over quarters We to be fairly ratable R&D the year.

In the R&D meet the for BMS I would addition to highlight to in XXXX. the key focus in investment to trials like us In order other and begin of time line in to manufacturing planned our large-scale complete of new our launch validation commercial filing for year. commercial BEMPEG this few in collaboration, commercial BLA And potential of a XXXX. areas we and expanded of plan supplies process manufacturer

expense BEMPEG collaboration, manufacturing continue in XX% will a significant component BMS BMS our XXXX. of to R&D our costs. Under BEMPEG costs of a manufacturing result, As be shares

And invest and Vaccibody. with our non-small BioXcel continue we study In development the addition, in outside cancer. with cell BMS pembrolizumab will in of other under PROPEL Pfizer, in BEMPEG collaboration, with modalities including to collaboration combination our of lung

Our and Phase II studies in R&D of initiation two studies atopic dermatitis ongoing and the expense includes psoriasis. for NKTR-XXXs, the IB also Phase

As in the second Howard the a stated, planned Phase autoimmune half study and disease Phase lupus first in begin in study II the start second XXXX. of will state is to new II midyear,

we As our collaboration Lilly, are these a reminder, with responsible costs. for of XX% in

and NKTR-XXX to is noncash for we and $XXX to which XXXX for expense. expense between million $XXX in depreciation work our compensation NKTR-XXX. stock addition, G&A and continue will million of projected be In includes Phase I/II million, invest approximately $XX

of expect $X million. our expense interest repayment $XX in approximately GAAP million XXXX, income to will $X With XXXX million of XXXX. For million interest as million notes, full compared be to year $XX $XX.X we senior to

two to $XX in $XX million we related income between statement on of contract to the expense related of the noncash million This composed impairment also $XX recognize QX $XX an In to of million and primarily the million this our program. record is noncash related cash We of approximately CIMZIA certain impairment to legacy expect $XX charge and MIRCERA. parts: non-cancelable $XX commitments. $XX and million between of million, NKTR-XXX and million to interest discontinuation year, plan charges of payments to charge manufacturing

stated after and I million senior secured $X billion approximately cash in end our of we with notes. $XXX XXXX As repayment earlier, in investments to plan

And that, questions. will Operator? open call the with for we

Operator

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

line open. Your is

Chris Shibutani

Thank Good afternoon. you.

OPDIVO think the with lines? both enrollment been in to have in your With can there you progressing, you road. the may place that programs the have some historically, give how for a with sense talk helping initiatives as lungs, in you confidence Can put BEMPEG pembro engender program what us in about be I with well time is bumps as

Dr. Wei Lin

Hi, take this is question. that Lin. Wei I'll

the as So in our in combination is two In strategy call, BEMPEG stated combination as really nivolumab. pronged. with the combination well pembrolizumab lung, our regarding been as with

and that's combination And patient started us have being at with more of nivolumab, follow-up fully details least for as all, by a the to worth of expect And study XX we that data to First enrollment. operationalized year XX being the that And Nektar. has year pembrolizumab of has along. so we end expect of that assessment two we'll operationalized allow not sufficient at by activity. that's BMS. the a scans opened study yet, has to goes combination provide The the

Chris Shibutani

may sense, which results for what myeloma, kind us that efficacy JZ in with we etc. that And data setting can a here, then highlighted likely see see are asset those indications an be you frame XXX, we the two to the of give Great. monotherapy maybe of seems to

Dr. Jonathan Zalevsky

Sure. is Chris, this JZ.

first-in-human be we'll because late-stage a that disease, have pretty remember, this study. exploring So patients is

we're typical a So with we're with like kind regimen. given small of level. way disease, treating at patients dose patients advanced And a very dose of salvage numbers late-line any in escalating in

get outcomes also pathway a we'll Chris possible may to in the settings. see the deeply monitoring that all So be addition will of of of you the this agonism. be study liquid these responses action that IL-XX into can mechanism setting we diving in in kind tumor in any first-in-human of

changes induced be by expect to for looking systemically. like tissue, mechanism the also be where cellular be in we'll there in the We'll So cellular this action. bone compartment, of changes looking example, we marrow for additional

we we'll results So the totality to be the can this as looking present year. of

Chris Shibutani

may what in be medical that top Or meeting? form come? And will lining remind at setting ASH? the At a or me data you

Dr. Jonathan Zalevsky

most would medical at correct. a Yes, likely it meeting. Yes, be that's

of of So couple that the liquid think focus. that's you where could good are are a There example. tumors a others

Chris Shibutani

to look good. Sounds date on forward to that you. Thank We program. five five

Operator

Thank you.

Our next question comes Sandler. Alexander from Piper from Duncan

Your open. line is

Alexander Duncan

the XXX bladder more superagonist and investment doublet will you're a we maybe there broadly see space? given in mimetics then that the or more most and moving be Nektar's for a forward more program, had as with down questions and IL-XX confidence as gives compounds in platform, Hey, discussions to triple, bladder some data BEMPEG. to XXX competitors the for have the doubling you cancer what positive evaluate you recently And as cytokine ideal combine thanks in

Dr. Jonathan Zalevsky

Yes.

are there there. So two questions

Let's start with the first one.

bladder settings are the a kinds first-in-human is of well. infiltrates, tumors pathway characterized of that nonoverlapping we, lot into is number apply the that tumor also NK as can study, in And tumors, the like features are appreciate IL-X, you settings. pathway only but broadly, IL-XX engagement. the of broad one There features with liquid it are not setting that cancer shares a of, you of GU of share those. are stated, solid we NKTR-XXX, in some with that And So agonist And cell a and mechanism. kind of very others which there is that tumor this

even it opportunities. And are the with application So also that XXX selected. there stop are definitely partners with goes broad it very just combination because very, doesn't

example, including from indications For that many tumor targeted know partner, things large combination like an of you to kinds cancer of like B-cell, with opportunities. wide range across types, of therapies the the you consider many, incredibly NHL rituximab targeted breast have ranging therapy you agents as Herceptin when all

for the second we'll looking that set yes, of XXX. development the works about be on. a And for broad very on So cytokines opportunities question Nektar

in approach our that hurdle with following cytokines. in and able program really other our to our BEMPEG I a to are behind bar and field have properties sort that quickly differentiating that And a built inject We them been into sense obviously, a the conjugation for us set very that we settings. have with We've chance are new advancing momentum. kind had multiple deep that regard. we've cytokine into us, Registrational the of and targeting obviously belief in with revitalize molecules a we've to BEMPEG. building And that And the they companies the whole to platform. us. aggressively have behind the of very, Into mean, that results think we've polymer that chemistry I other very been off those deliver were we've chase companies of

Alexander Duncan

you. Thank

Operator

you. Thank

from Our Jessica Morgan. from comes JP next question Fye

open. line is Your

Jessica Fye

Can decision And to you Hey, guys. Thanks on interim the on III the could basis the for my based one if you Good potential that melanoma be given accelerated taking question. shift trial serve have complete it that they from in front? might as to first-line FDA based the the rate. on so, to any change about talk CR response evening. pursue you feedback feedback Would the Phase for approval? on whether success

Dr. Wei Lin

pivotal Hi, designation, Wei that certainly I based this extent, in that our first-line breakthrough is response assessing our two pathologies in on of to think melanoma extent, and endpoint to very the a data. cohort. Yes, a obtained seen was in the complete we on in we was the it And using based large totality encouraging large was the Lin. quality

ongoing discussions worldwide. agencies Now multiple agencies, we have with do

discussions. update regulatory a to endpoint something first we'll that complete take as the as And endpoint further at. provide that Regarding we look that's those

first right is the formal now, ORR. primary still on So readout based

Jessica Fye

Great, thank you.

Operator

you. Thank

BTIG. next Bert from comes from Our question Hazlett

is Your line open.

Bert Hazlett

taking of for I Thank you. them. have the you questions. two Thank

the to pivotal in match melanoma, patient able do characteristics any seems anecdotes in you been that you've want of it you would is, Phase the in First Can give that X. III, you to first-line us Phase III, that versus share program of shown? I. you've And JZ, Phase $XXX saw you you safety that the want in study, of secondly, in the you pivotal mentioned safety, then results characteristics any the the to million PIVOT-XX could that

Dr. Jonathan Zalevsky

Hey, Bert. This is JZ.

that So Phase sure risk enrolled III the cohort had did we demographics in That population. that same one the that array of patient and is of would match the PIVOT-XX factors. we the baseline made things patients

LDH, upper about patients for patients MXb, which the lactate into entered of the limit of liver a cohort. that very, patients for metastases we as would you with did our are of liver status elevated severe stratified the PIVOT-XX our prognostic results our X/X melanoma. X/X being to worse BMS if the with So patient that was MXc factors normal, patients as elevated MXc And of have or presented well similar Also sort or above we dehydrogenase that for the in or of example, is levels, presented about XXX, with and more why population III. the in Phase And that, published had our actually that we that was match CheckMate PIVOT-XX look very the what at ensured reason LDH proportion fact, mets and cohort. the into

cohort of that's last a it case, not cohort the strength Phase that observed also patients had So a Very the looked setting, response single-arm III right And it for in its the And most by and you was asked very, population. when important but many we central because important data population with blinded in had overall SITC, increase the So for responses, cohort, patients most there matches review it important to complete happy PIVOT-XX a even melanoma, very we severe within was patient factors. mets a at independent liver even was the presented update prognostic poor question. at still that point. very that only we presented right? deep that that very that us, that severe the

second asking safety an with that's the about then And important were So point. to you your question, XXX.

for setting, agonist. And good a on results that administer we you and is systemic the systemically, to And saw that relative tolerated polymer to We're pathway effects. of lot very it intratumoral in very presented and to of done much to the is of create all things conjugation study TLRX/X, developing our it's all as and a kind and that the able use we you'd really much much, we're localized, systemic we a expect route TLRX/X agent So enrich thing we studies did where see others, in intratumoral that. was that a Certainly XXX administration don't and the minimize have better injection strategy, And an preclinically, intratumoral in a our residence injected a is compare we different our toxicology a because clinically. is seeing the experience infusion definitely systemic results that massive in based of that exposure. the very, have better as time this administration to in the it's you TLR way one of tumor. giving cytokine of than really In agonists. the

Bert Hazlett

Terrific, color forward to the for look the thanks data.

Dr. Jonathan Zalevsky

Sure. Thanks, Bert.

Operator

Thank you.

comes from question next Sachs. Goldman Choi Our Paul from

is open. Your line

Paul Choi

everyone. thanks good I have And Hi, afternoon, for questions. your taking X.

lines. regard is program first metastatic Phase III melanoma the with to The on time

you kind response the we should time Can comment fourth trial still you're on saw think quarter, the on of readout ct.gov enrolling interim months. to an to of with complete frame response just PIVOT-XX should But patients. is that about was in indicated be given see. rates, I thinking we as that the sort maybe fact how eight for what the we about CR

a effect. treatment Just be, the in be given, that'll or during of, time what duration sort to exposure hurdle might drug, the period

Dr. Wei Lin

for question, Thanks Paul. the

been in analysis, follow And for the think to that, to CR, CR you duration. to yet. So would as endpoint months. time if we a pointed XX-month because were patient a we CR the earlier, like is the not about probably been changed median stated out, And I as has seven CR of do

size health the based if sufficient duration of required the for followed ongoing that's going authorities going CR with endpoint. discussion the number sample that, And readout on be will there's be CR, so to the that were regarding a with that registration endpoint. determine And on based to the the

to is decided. of be that still some yet So

the absence I by whole interaction. probably projection be health think our the around current it's same But estimate, authority full of going time projected the this current all obviously, we roughly to based is current as on and ORR. in

made be the months. in clear will coming things those So

Paul Choi

fairly Lilly, XXX, the on just just areas. competitive you in then And program and differentiation? the Wei. of dermatological next that, your any are about indications, are there you guess, points with sort the advancing for are helpful. various you as an it's these as would particular Thanks think Okay. I whether the And updates, explore of any color or AD be bars, for other provide metrics data to could set of particular efficacy Any or indications you you looking partner,

Dr. Jonathan Zalevsky

Hey, Yes. Sure. Paul.

similar a question, couple you very asked is ago. of So this a days

benchmarks IL-XX out the and the know, in of setting So right? like those very Definitely, there, in others, bars some they're settings. dermatological unique like uses. we are the agents exciting And

is aware of of Lilly those. aware those. are we So

so of those judging nature for the indications. benchmarks advancement are in dermatological important of all And

there. So that's always

that thing is this that setting. second tough, is The being really important this applied mechanism is dermatological novel into a that's

we in to dermal skin fact, of that have even within the moving so there's areas of Tregs dysfunctional where And know expectations cell you growth.

plaque psoriatic For be infiltrated by example, vulgar to also we'd to patients expect AD Tregs be the Treg. in an or by infiltrated

kind kind you similar dysfunction. of diseases, other of that to in because for kinds also that whole is, adds looking that these see themes action be autoimmune And we'll of that mechanism So then remember the assessment. of of

because indications different we see inflammation. That's underlying are an Beyond and And But that tissues many we terms in the Not have important of just allergy a like represent as of different topic atopi is disease even the settings, tissue immunology, in see indication that kinds there so pathology many regard, can dermatitis. atopic similarities. a a dermatitis kinds also The compartments. beyond the skin, right? in in very of is because atopic dermal driver. atopi other

covered mechanism themes opportunity So of to consider the important the sense also how into very indications those two both those those even Treg widely within us specific autoimmune additional broadening indications. give and more that by a derm are studies

Paul Choi

the Thanks call. for

Operator

Thank you.

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

Your line is open.

George Farmer

complete III to like more as endpoint an response the Hi, in for using questions. ask about my thanks taking I'd melanoma study. Phase

determine is the Bristol-Myers What approach? is be for to is you an accelerated And submitted using do to needs important? do whether board CR you the is with think delta this Firstly, order an about trial be what one. Number achieved, that think, approval? how in on two, number should

Dr. Wei Lin

Yes.

this. with us So first BMS is a all, on of we partner certainly

We should enthusiasm we based And have BMS FDA agreement shown really this that that a very is discussion. the much with pursue. in had also has the endpoint CR endpoint, on valid extensive is

of in bar. now so terms And the

the So the read to which ongoing to X% bar out. is time expect about studies, to a is in sufficient be our nivolumab, at X% with follow-up conform that we

So possibility probably XX% of the error. to able to that be improvement, would type the adequate benchmark. be statistically And being we'll exclude something target around this one a

that's XX%. we're number. to on data, just rate So of based based in it the our that about is so CR even follow-up, XX-month on trying per And was our to that's remind months what back project now, I'll at think I So you, with with pivot follow-up fact, right about percent, XX XX right?

we in the if So as year, a at to that able of clear of being PIVOT-XX, nivolumab. we're improving seeing past can upon this in what seen replicate confidence bar we we're good have degree least

George Farmer

study? Yes, we'll do Okay. when then PIVOT-XX think do survival more overall do to from results able that think you ultimately some see very And data, you you helpful. that's be present

Dr. Wei Lin

Yes.

as is potentially on to update PFS as from the deepening in CR would on of cohort, year, two we we're would PR of well of half changing from least still like what And new there that patient melanoma patients follow, provide are response to and second kind CR. continuing a to estimate treatment, potential who a One PR are the any the at PIVOT-XX, to converting of So number patients potential have be. possibility on two there's in changes.

of with of about medium a follow-up, survival progression-free with XX as has months seven not estimate have to As a even really PFS, we months a PFS follow-up, we reminder, the identified can PFS. reminder, longer longer of nivolumab yet. months And potential. six And seven

current our study. So that in is the benchmark

George Farmer

data forward? imply move on lupus, Phase the that good. that what Great. is moving Phase decision that drove that a in I II Lilly finally, into the to And is Ib looking forward mean, does fact then NKTR-XXX,

Dr. Jonathan Zalevsky

Hey, George, this is JZ.

the they'll benefit. them mild Obviously, II duration II studies more was dose Phase ran entered also does. this and study certainly deeper disease is running for So obviously, ascending that lupus. with Lilly, indications. four the multiple you into be treating longer completed population. now an lupus least Ib than severe they'll into And the study, Phase they've much four remember, ascending to a And We much, Phase study, for moderate moderate actual patients study diving dose then to multiple moving that agreement, therapeutic multiple as autoimmune into at we be if across with in

question in of by ways two T that Now disease, we has well-characterized progressive a a in have see T then in a don't actually, why And cells biomarker you and relative lowering that's patients compartment. the cell It's Lupus circulation patients great in lupus. manifested a this dysfunction and And capacity. see and well-known we Tregs to lupus, driven regulatory healthy have patients, the deep you asked. with And very decreased lupus disease, both their number regulatory see that especially patients right? a of also NKTR-XXX. application suppressive

test So when functional from patients assey, isolated you at very function you from Tregs actually immunoregulatory to poor them lupus very, isolate and in they're relative healthy Tregs donors. a

themes, of sort represent mechanism For in of two this NKTR-XXX right? therapeutic into both action key So of disease. those applying this

EULAR Ib Phase look later some II to to present to an this data look year. Ib, later patients the Phase also that lupus even in year. we starting already update forward We on study looking to Lilly their and study We abstract data. forward we're giving presenting submitted forward from more an to from the So Phase this that

George Farmer

Great, thanks, JZ.

Operator

Thank you.

comes from Jay Oppenheimer. Our Olson next from question

is open. line Your

Jay Olson

have Or Thanks muscle-invasive data factor? expect other questions. taking to or PD-LX tumor all-comers? it the expression burden the decision see move will you doublet the for Can or efficacy into that to on in talk level some And you depend cancer? about your do it you bladder mutational supporting

Dr. Wei Lin

Wei. for thanks question. that Yes. Yes, This is

benefit the there PD-LX we data, data seen to is publicly, us negative going as we've data the fact, bladder supports us in going cancer, the same as in support well the shared the So data disease. in positive. that the have actually to muscle-invasive metastatic set into And

regard metastatic is in to be study. sense our a, it the And like to could status, all-comers, the but just this cis-ineligible so is PD-LX the limited it population,

Jay Olson

in a profile? you based Or for then describe can Is superior And great. Okay, efficacy? rationale that looking a on the TKI regimen. potentially pursuing for AE sparing are superior you RCC,

Dr. Wei Lin

is on based profile. Yes, it certainly superior AE

As plus that. level you AE high, at it's grade grade half the it's the axitinib treatment. pembrol AE, whether actually higher cellular three you or axitinib, plus that due patients know, avelumab look very And over to there's actually discontinuation during very, or of experience three the

with really to can maximum both addition, provide the the benefit. way And and as subsequent really checkpoint using therapy. the in reserved most a expect, line And available of first so a line, having by one still spearing if on exhaust the keep as a a regimen basically you combine as drug, in option, therapy. TKI can to TKI second the we we if as we regimen first-line, that's TKI a physician patient provide the And maximum well benefit patients

the benefits I think patients. those all are to

So really not reasons. Obviously, our variety has due those there at caspin. patients multiple considerations are study designed who PST that eligible for TKI of are to initial are some been has

option thought we all so very provide to for And to reasons. was it that important these patients

Jay Olson

for questions. Thank much very taking you helpful. for Thanks the super

Operator

you. Thank

comes Our next Canaccord. Lee question from from Arlinda

open. is line Your

Arlinda Lee

my are we There reads differentiators was around other questions. right at do clinic landscape? you now. competitors that I to be assess I competitive help in the what a look space, some interested taking seems or Hi, at look roughly key for in IL-XX. the was entering maybe curious should number guys. of think Thanks this to and early

Dr. Jonathan Zalevsky

this Hey, is Sure. Arlinda, JZ.

are of receptor X, other and IL-X is cytokines the they about XX the one multiple ones have like all of their as like certainly, IL-X, it So the ligand family it that biology. interactions things like class, in IL-XX, part same

with So a right? And And of course, you shared that's know, XX there's as like common alpha a signal beta different through dedicated receptor, common is of receptors. gamma, then is shared gamma and that. cytokines there over chain, set usually or gamma

so very And and the receptor modes cells express the binding, receptor important. IL-XX, three binding. interactions, that nodes in believe the are ligand complexes particular, And we all there's are of the different at least for

because beta trans. different a that's driven modes sis a IL-X in binding. and the we So soluble kind alpha the it's receptor cell-cell trans that there's or is in then in And call important independent is a sometimes it's And there's it's beta cell neighboring And on lot and IL-XX if two a one One cell, by binding. we alpha IL-XX different call kind molecule a cell-cell that ligand, the then contact. of functioning independent, when works of IL-XX of at cell, it gamma same superagonist. contact gamma binding, receptors interacting dependent IL-XX presents driven onto cell the level has signaling alpha complexes. as on that the bound particularly called dependent like And on with of when

all is our because Now with of alpha. NKTR-XXX very the those pipelines they IL-XX receptor in the from IL-XX have in different complex competing molecule settings, of all

and IL-X the binding mode molecule that gamma. they molecule, all SUNCOR only or interact with Novartis the So and really share and or like they Sushi Domains Altor of one really beta the just primary others the receptor

interact either binding to or the modes. unable alpha-dependent sis in trans They're

So it purpose. preserves all designed receptor whereas of that and available on ligand complexes way NKTR-XXX the we

examples means we've what of that's firstly, then receptor the shown a that So differentiation level. at biologically. scientific And

higher So presented of that can we sustain. and grandzyme a data IL-XX to the CDXX were unable XX complexed we've are those publicly. we monocytes, activities targeting induction, in two induce And induce receptor interleukin can expression versions that

at no evidence important think I molecule I of NKTR-XXX it far, think where going look of see should another a any of will some to of that's to in there repeated effect? to to distinguish if one The Is And evidence have to loss really pipelines. because that a is kind be other relative is you be place thing place with tachyphylaxis dosing, as really less other important far look the going itself that's tachyphylaxis or a really at biological like

Arlinda Lee

might Is something show the in up Phase I? tachyphylaxis that

Dr. Jonathan Zalevsky

Yes, yes.

been there's other So publications molecules. from

from the of that publication molecule. upon loss of in patients a effect, specifically that the dosing, biological with the as shows clinic blood of the expansions, that measured outdoor a treated cellular example, have there's they at level repeated in For molecule

Arlinda Lee

you. Thank

Operator

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

Your line open. is

Andy Hseih

was within in if taking kind RCC it's remember X%. the I of interesting cohort for RCC, the my rate drives I CR And because thanks Great, question. In think about correctly, front-line it's a adoption. setting, CR

guess, company at year, on think well, last just I So data the had curious if I planned ESMO. presenting

about curious steps next Just of the release data cohort. that for

Dr. Wei Lin

So of half earnings we it last year. the the second in have call, shared toward data last

no been there's new RCC data. update the So regarding

medical plans a to have manuscript form. another in plan on So have we and RCC don't present data, any that presentation the major eventually to but congress do we a

Andy Hseih

Got it.

kind Okay. on just of XXX. follow-up Bert's And question on

tumors. positioning strategic here as solid So a have how potential and salvage less that in so a you'll that combination assertion? is the checkpoint a a Is as BEMPEG XXX correct salvage various regimen

Dr. Jonathan Zalevsky

Hey, JZ. this is

for for time, rationale we first program we when presented XXX. the the described So remember, this

an And in signal owned to it adaptive doublet a which specifically it comprehensive and it's an expressly that BEMPEG. kind Nektar developed has. a be is so addition was developed immune really signal, innate So used And in You wholly have response. providing BEMPEG, that we an right? really, to of with

with really activity all in evaluating disease. to patients it's very in be then development of the begin So of We're uses could it broad. terms it, clinical the in the of quite choosing late-stage

triplet of types. by well that plus to we know know, going as basket BEMPEG. multiple study as you tumor different the evaluating doublet solid mentioned, we'll types, you a focus as setting of patients relapsed/refractory forward. on rolling as very with kind move a like such the is combination tumor as advanced with we well REVEAL a But we're certain tumors And NKTR-XXX the as of in to melanoma checkpoint as inhibitor adding be So

combination. there's of this kind a lot like to Now we're the beginning setting. I really development We'll but be relapsed/refractory a in of opportunity said, use beginning, the

remember, program, things immunological deep the the preclinically, of was saw, really with we that a responses. abscopal, of set it One

you for And was, it this of moving it abscopal, cancer benefit one and one get tumor to animals' we But presented showing, time have only needed multiple in the that full body order reaction tumors. immune animals tumor, data where in only inject and the really to the a immune example, how immunotherapy from that distal tumor. we was no matter And matter injected any eradicating call no kind is and the original of, an response throughout response.

really so of one And the of again, that the visions was program. predicated

the and as that that very move work we setting, into so could lot molecule of that regimen. as demonstrate that And way, can and use in a broad that broad opportunity for give we

Andy Hseih

And of in dosing in non-small cancer. terms lung cell Okay.

studies, that you other pivotal cell how about to relative do dosing lung a in increase cancer cross differences phenomenon? of the in So is indication kind think just Or non-small dosing? specific

Dr. Wei Lin

Yes.

is to couple underlying are there plan I kilogram well which lung And thoughts we in to Registrational the certainly, Studies per a a all X-microgram cancer. dose our that is And enabled the supported data designation. with trial our both in melanoma, think RCC. as melanoma, our expanding non-small retraction partner, And breakthrough and PIVOT-XX as optimize engaged there cell all data the dose, certainly, for and our to by of by in we BMS. that's cancer bladder sufficient the stand

activity there. clearly the local So is

we're quite current a the able together AE the nivolumab. control better giving dose those a look us BEMPEG the a learned challenge of I could That's from cancer profile about to program. the and than plus BEMPEG, landscape safety different greater well, started one. management fact another that we highlight we're much all and the and that believe of all the benefit with there. think we biology that's requires patients that's cell other guideline, think treatment why the XXX and biomarker, higher reason BEMPEG non-small provide cancer lung dose we the for undertaking to And combination try. at we monotherapy makes disease we this non-small also And with cell dose, at another take the optimization. dose quite, as of with nivolumab And when whether treated And lot lessons, a we've we around the a hypothesis can since like actually a is, the certainly

able Study long in to achieve if forward. dose the that than we're using higher move be potentially would So a dose Registrational to

Andy Hseih

last Gil. for And Okay. question

terms Just from kind the in Bristol. us remind R&D of of reimbursement

a excess cap, cap is reimbursed basically the annual there the think I quarter. first and get amount in there's an would

anticipate modeling into do So you of head as how we do you quarter? kind the standpoint, that from first a how

Gil Labrucherie

Yes.

that GAAP year So right, remains under under that we the the we'd reimburse cap the $XXX end exceeding reimbursed the is way we cap this quarter. And of we is million there for agreement. expense on cap that year. year revenue, there expect following in the Andy, sharing the will would the agreement for exceed you're that's works a R&D And toward be and it the the

that So in, would come cash in XXXX.

Andy Hseih

for Thanks questions. great. my answering all Okay,

Operator

[Operator our Instructions] question from SVB take And last we're going Daina Graybosch Leerink. to from

line open. is Your

Daina Graybosch

for Thank question. much the so you

neoadjuvant a first The the is trial. trial clarification a stage adjuvant trial? on an this melanoma going to be early Is or

Dr. Wei Lin

arm nivolumab, adjuvant an for which a The conformed the is It's restoration currently label for with study the control study. will trial. approved serve as

Daina Graybosch

a you are NIVO And here? the melanoma, agent, out missing in on really Or IO, benefit the setting neoadjuvant the we've Because seen also follow-up dramatic that benefit? combination, neoadjuvant about worry single do alone especially the in that. on in but setting patients beginning with

Dr. Wei Lin

possibility. That's certainly a

standard small the teens. patients care, the in setting are standard neoadjuvant approval this I of very cohort data in not practice, most actually think the there's current of in that's generated really because no

study, done I any certainly, be And a in And already think given been care study. there's the in to of adjuvant undertaking full for large by there randomized standard so for undertake to that's adjuvant for established the an is that trial approval setting, setting. sponsors attempt the neoadjuvant right such has no what's a been now,

treat and neoadjuvant's can not may patients, predominant clinical physicians selected some the our for practice for is think of adjuvant out, academic expect of overtake study time care. neoadjuvant some hence, now, neoadjuvant. foreseeable practice within certainly approach but standard re centers treat their going be to to patients going So in I a themselves frame may And using future, the we reading don't that

Daina Graybosch

Thank for that. you

the interesting as is very in potential on response quick. frontline usually, rate melanoma the the study. back Second endpoint question It's CR metastatic because

continues how certain the have CRA comparison all getting the nivolumab whether it also pembrolizumab over snapshot interim, CR time, if of you or that have of we think but the mature a of data at alone. follow-up. to And you'd about of I amount number But get with a rate, four over an I look to year looking you're know at melanoma, three thinking that You in wonder years. deepen a or

Dr. Wei Lin

Yes.

time use in based CR our a on potential certainly, time basis seven our to months. as confidence CR of for previously, PIVOT-XX is actually pointed our out data meeting So as is this been approval

four XX%, XX, plus NIVO/ipi a actually very has CR there's is five be after understand with over that year we'd of you rate a to time. NIVO XX%. of prolonged achieved follow-up deepen years not is to on accomplish CR ipi different I it which years. there's rarely true than data, CR little follow-up, and long has even higher And what But fairly very even XX%. of than achieved able just And with it's CheckMate So NIVO it's follow-up, follow-up, the fast. a to if based look nivolumab up follow-up, five with over the does prolonged at

is the to the time quicker. can is think nivolumab ourselves And really has of rate much plus a follow-up, It's distinguish arm. during and control the achieve really what that right? factor, truly of distinguishing PIVOT-XX So BEMPEG in so the plan we I CR the we with that to study able at the the think even from nivolumab XX-month have we the been follow,

Daina Graybosch

a of have cells. as lot for and or NKTR-XXX malignancy wondering especially know JZ We function patients And dysfunctional restore around And exhausted XXX. I'm well? Great. NK if hematological can NKTR their perforation patients, one last question

Dr. Jonathan Zalevsky

population. patients of one in the to we're multiple with our in reason part definitely of look with NHL, things that's that at. we starting very, excited it's myeloma. late-stage and That are very why Yes, have And late-stage study patients the particular, patient the

cells compartment, really NK and cell terms that Dana, have know, deplete like degranulate well. as can status particularly down. both myeloma. effector right, for after even to cell multiple further And catastrophic, dysfunction maintain that that be multiple massive, agents cells You example, in or example, There's of ability to particularly these go and the for in in numbers even, can dara, well, poor CDXX any a in

biomarkers trial. earliest at of that So our the definitely, clinical we're one in looking that's

measure. these because all to systemic As compartment measure the very it's a cell you and central cytokines, with blood-based changes know, And we robust time. it's measurement, easy

key it's for a action testing biomarker our definitely program of NKTR-XXX. So part mechanism and of our

Daina Graybosch

Great, you. thank

Operator

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

Howard Robin

really built today. everyone, suffering states. autoimmune numbers disease liquid thank to many I'd across hard company. chronic potential in large large And employees joining of solid indications autoimmune immuno-oncology an highly and we've pipeline and commitment disease in multiple in our inflammatory for and need work us our have Nektar high across for you, patient thank to tried serious immunology. treatment usual, address their populations Well, valuable and where tumors their Okay. a patients from unmet programs as to and And are of really has like disease medical a

on forward look the look So seeing you provide to we our the months. progress and you of several many advancing we programs, to these over to growth, forward with continue at conferences next

you. look joining us and you. very today, we forward Thank much you to for thank So seeing

Operator

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

Nektar Therapeutics (NKTR) 28 Feb 202019 Q4 Earnings call transcript