NKTR - Earnings call transcript Q3 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Nektar Therapeutics Third Quarter 2020 Financial Results. [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 the With COO; Robin, call our on Dr. President our Howard Labrucherie, are us Gil and CEO; Jonathan and and Zalevsky, of Development; our Head Dr. Research Development. Lin, Head Wei our of decisions, therapeutic call, plans including trial and financial and for data business, and for plans future our today's regarding results, clinical future the clinical regarding health clinical certain we business. our the our authority pandemic's predictions other forward-looking clinical drug of candidates, enrollment and make COVID-XX actions of outcomes On statements business plans potential to trials, regulatory our and for trial and guidance statements of timing expect estimates timing impact on presentations, future clinical and the trials, and the control. forward-looking of they uncertainties to statements to inherent are to our risks many predict and these of subject relate and outside are that difficult are future, which Because uncertainties filed Form are the set in X, Important available www.sec.gov. is August risks which on and at forth we that XX-Q XXXX, no to information, whether new of a any otherwise. as obligation update these of statements, developments forward-looking result or future undertake We A nektar.com. IR website of Nektar's page on at webcast available the at this call will replay be

all of over With and we ensure call locations, no are Howard? Howard President for listening. to that appreciate disruptions as Before those all the moderate during call We session. work CEO, we issues as the for team, to patience said, are hand from can separate turning so over session Howard, I our your our dialing the I we there that to the will in Q&A will avoid Robin. technical technology

Howard Robin

joining you the thank on today. and Jennifer, call us you, everyone to for Thank

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study are We we've that Wei the and in the projections our more program well share made study, for the this about progress -- of enrollment in PROPEL ahead more a program I'll about that moment. let in

more IL-XX program, follow-up of for PIVOT-XX sets melanoma data our with our for than SITC, months our from XX for Next those as patients as bempeg the present in immune-oncology including new we candidate. week NKTR-XXX pipeline, data first at several well will data updated

and XX%, of complete median with rate a the reported and a target as for excited week SITC. bempeg approximately is X last sales of The KEYTRUDA in quite RECIST cohort response share after bempeg recently months, melanoma know, led studies We're PFS. PIVOT-XX, you reference, designation in updated patients this As in market reported combined patients XX in of X importantly, opportunity at XX% these reduction results from we addressable with that a strong Phase breakthrough yet X III X adjuvant for results for metastatic lesions. this And XXX% their SITC had These melanoma, significant large to OPDIVO therapy the reached PIVOT-XX a billion. bempeg $X are the for a setting. to in melanoma and setting not these very plus results we at cohort in nivo high next year's first-line experiencing areas

nivo the the Phase plus in efficacy by this readout. III benefit continue optimism demonstrated we be as with and great data We study, bempeg maintain impressed to await we

Phase NKTR-XXX patients study ongoing you'll initiated multiple paradigm Our program cytokine second our these study data as also patients. I/II join with well treatment ultimate goal NKTR-XXX in new lymphoma tumors. trial to We've an adds of Nektar in This the analyst is on with next for experts November in pipeline. with evaluate a discussion. to betterment nivo we a for key IL-XX will solid myeloma. Phase our XX our non-Hodgkin's discuss and hope for establish NKTR-XXX, the And event SITC will us melanoma oncology patients new that recently I presentations, bempeg The and with additional host and in of plus the to as

the biology approaches, NKTR-XXX as of which the targeting of IL-XX for fight cell well designed is harness interest cancer. can gives to significant as agonist cell NKTR-XXX interactions mechanism receptor-ligand killer the currently response NKTR-XXX are of designed natural this reminder, as as effectively this cancer the of boost Natural to in pathway. immune restore cells to killing agents cells. expansion and a T gaining capture enable patients, ability meaning memory specifically to As and CDX+ their is expander great full all survival more the IL-XX designed the the to them the other available pathway, believe unlike promote killer ability IL-XX We to a that act was

which at corresponding treated regulatory new Lilly of NKTR-XXX, with with the also For order magnitude Treg designed a of many function numbers with underlying regulatory conference, dose-dependent to and disease immune an with they a is of reduction and Most in planning NKTR-XXX, atopic we experienced own T of in a patients T colitis. lupus in In notably, in cells. Phase Rheumatology lupus, a of know I observed listened patients These whom in College impaired with yesterday patients correct American and we patients X reduced increase in investigational started stimulating a Lilly's study imbalance you presentation. that to to of psoriasis. presented in ulcerative many autoimmune in and first-in-class cells study Phase are QX, II second conditions, studies II ongoing agents, Ib is symptomology. addition of data NKTR-XXX Phase their dermatitis NKTR-XXX are

the We forward this are that advancing very development expansion pleased Lilly to program. continued and we of is look NKTR-XXX,

reviewed know, we to to of of evolving COVID-XX you employees business. landscape, proud all To interruption are very were remain time that least we As lines pleased results to our call. end, discussed working that I'm continue -- ensure the our amount hard and I'm our with financial the to navigate who of report and previously our August on were track largely reviewed that trial on

study, first-in-line the focused study the cell are first-line ongoing we adjuvant the metastatic remain bladder registrational study, cancer first-line bladder with and stated carcinoma plus the melanoma the nivolumab. studies oncology X study. and melanoma bempeg study on highly muscle-invasive I renal earlier, the As These cancer

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BMS, the being as early PFS COVID-XX study, because The to to melanoma ORR, last study, previously report or approval. has data designed in metastatic XXXX a first we full PFS quarter, These is sequential in is delays study the X OS. of are late which expect and endpoint XXXX. endpoints, stated endpoints: For we support by and that the run

in For part ongoing survival In in from recent result, the patient cancer. cell registrational of the same cancer, non-small investigator time study been expect analysis the we've this scans in study. of is the study, for non-small for of the time. part first which plus data pembrolizumab, we minimum there's the first-line in cell setting. for in XX interim the data a in lung PROPEL RCC, expect ORR inform study, with bempeg strategy X duration lung cohorts line Merck's reporting of now into this will bladder for enrolling preliminary first a first care a around And cancer have And response similar actively We treatment patients overall non-small of enrollment. our for this we of a expect program XXXX. increase will we significant we These cell that a our standard XXXX patients cancer and approximately are as the of that a bempeg on ORR interest seen and established lung

for You'll recall to that XX that only we thought have XX data would was patients. available our original

with investments over a with pleased balance the and the billion and strong debt. speed We very in no we're with enrollment. quarter cash third of So sheet, $X.X ended

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Wei Lin

bempeg settings of you, to as lines as cancer includes bladder registrational the adjuvant and cancer. X Thank bempeg the in as in metastatic front-line care time and for registrational like our studies review standard Howard. melanoma I'd and position well program, to designed progress kidney separate the which

first-line successfully to Since enrollment This run study result me online BMS. partner, the with the Let of in countries. summer, effort which many the a they to time study, have as bring BMS able for by more been lost has in COVID-XX activities metastatic then, melanoma begin our sites been remedy investigational pause. restarted

plus earlier, In or melanoma progression-free III rate breakthrough complete overall or X As we for have we the rate and response response a destination bempeg OS. observed PFS; ORR; the have Howard on endpoints: survival, survival mentioned population. we first-line study, based high overall received Phase nivo in therapy the

OS. enable the X/X in endpoint least patients to early more to have This look nivo the the The ORR would study therapy was and Because approved. for nivo submission of in X doublet will we a potential in include After this interim The could our you response Europe endpoint of ORR if the of the for arm doublet, be approval first comparing readout made which whether who bring patients intact have be authorities, us the high on designed existing application complete plus quickly to of an BMS ORR. the for the and bempeg use many follow-up. approval months health innovative asked with and full at this U.S. have accelerated protocol the monotherapy will leave of arm in discussion will PFS as with Nektar of rate, the an decision endpoints. global current in to about registration of based instead for and multiple bempeg

X be observed study this arm study. X.X XXX comparable original the with The months a to median CheckMate and study endpoints of OS. So the of the the ORR, PFS original PFS for assumes design to in continues nivolumab

ORR to upon analysis X For X design, the our its analysis. is original study, the about PFS to projected months after based occur

metastatic PFS as we blinded an registrational well, in respect reached the for enrollment this of to is including study. goal to the number September study analysis However, our a could review review. time event-driven bladder timing data independent needed the readout With first-line impact factors other the cancer, in by and

the XXX the primary review endpoints as duration of a or was radiology confined critical a who led duration PD-LX-positive bladder in this filing. a determined response study have lower, the ORR about part cancer by setting. are patients population single-agent important factor basis this to XX patient for accelerated a as approval response score metastatic inhibitors The endpoint As is reminder, checkpoint of which of a in will baseline differentiating central and in because -- for that accelerated for approvals this serve cisplatin-ineligible endpoint potential

XX study a As a of time study, first XXXX. line carboplatin data This response. our the to combination planning the regimen, this brings duration months follow-up standard-of-care part are gemcitabine assess compared better of this for first for for the we minimum to of to

approximately second includes in TKI a be of reevaluated Nektar in triplet of development that Phase interim plus which BMS to overall first-line we and for analysis will bempeg early kinase XXXX, The the either to will indication. end we and the guidance. the nivolumab earlier, which a track patients recruiting bempeg, expanding endpoint on a initiated tyrosine Based To the setting, XX-month projections enrolling this upon inhibitor. RCC. bladder part, addition run of plus treatment period our quarter the renal with in compare patients first renal sites nivolumab more which axitinib III bempeg new and the for or study of patients this have surgery. study, plus cell to primary year. I/II The survival prior For a study, and bempeg as The remain for receive cell cabozantinib carcinoma Phase is study combination guide plus this started study, plus BMS, a this the the nivolumab which enrollment is on following the a of been then formulated TKI also first achieve stated been with muscle-invasive carcinoma, recently in study, Howard expect in triplet to comprehensive means generated the nivo cancer or our will for nivo of approach who doublet actively nivo have bempeg and in with monotherapy has ongoing throughout study XXX BMS consistent by

As this data we first to study is expect the be readout XXXX. in longer,

in schedule, enrolling. adjuvant additional initiated study III the important QX, now registrational this for the Finally, melanoma we actively well study, ahead is trial of and Phase

treatment study in melanoma, with the of the position potentially as well. to that endpoint as agent. bempeg us XX-month and for of an benefit of expected can number it for of standard trial an As The this postsurgery are from from opportunity this enroll this patients will provides survival. care Initial new period event-free treatment a study and XXX XXXX data Howard significantly the stated, increases patients

X%, in PROPEL, leading For we've last each now surpassed pembrolizumab, months. had non-small for will in have from interest our we we our data combination the enrollment of have who with PD-LX scans lung in XX first have of in And Europe. X% centers more approximately than less great cancer have the and P greater available data from few XX% and that X thoracic part cell study approximately expected expect of more available the the more this to XXXX. from first the or and from patients XX study cancer U.S. who with in in study We or part XXXX had X XX% in the consequently, patients scans had

we noted as COVID-XX last a initiated of for patients. the bempeg proof-of-concept Finally, treatment of we week, have clinical study

we adequate lymphocyte of of counts immune an adaptive disease. to underlying a And infection. opportunity daily lack low to have who highs to potentially patients cases. now be to baseline bempeg new the As continued may evaluate in viral in that observed States an being of coronavirus result an United the address severe the all-time hit We phenomenon more in saw that on a is to know, observation these go patients response

now bempeg and T Florida Our We're hopeful sites Temple. are to to who could virus. early robust approach and cell this to Texas a first plant with a unique open another in Pennsylvania study intervention provide in patients at need generate response more that

NKTR-XXX more to and like would over I the NKTR-XXX to our to call discuss JZ on Now hand programs.

Jonathan Zalevsky

Wei. Thanks,

disorders, a our study from develop these pathogenesis autoimmune systemic yesterday, are to new Treg begin brief Treg in manner IL-X. with NKTR-XXX And is more to me including Many native diseases. of abnormalities Treg reduced mild-to-moderate a takeaways. Treg effective lupus. key function IL-X-like associated with patients selectively stimulate shared few Ib important an we that update production Phase a like could Tregs ACR data than with With interleukin-X. reduced of goal address NKTR-XXX. on autoimmune are numbers, these decreased and/or our At and the out call in molecule to in NKTR-XXX, Let lupus, I'd deficiencies evaluating

at we expansion yesterday, with Treg NKTR-XXX selective, data of bright year, the administrations. maintained and NKTR-XXX As functionality. genes in that multiple Tregs. the showed led activation through we reported in to dose-dependent and This markers earlier resulted a dose-dependent increased In associated EULAR was CDXX Treg

reported first treated received only NKTR-XXX. The X study disease with also patients on in that the with patients the was patients time, For activity and we mild-to-moderate NKTR-XXX. observed doses of enrolled disease,

a at compared at score reduction X the to this NKTR-XXX. X And dose it micrograms a of So very X scores levels exciting. for complements greater activity activity in with patients patients number a was in changes that partner, a in or low-dose SLE in IL And these Treg as effect dose Overall, treatment. dose-dependent, we subset a Treg larger data from NKTR-XXX patients, now by in in PK lupus, looked ACR while The CLASI-A atopic had in highest X being the by dose separate started being to These well the clinical dermatitis dose-dependent treatment more these who experienced moderate and X equal NKTR-XXX their of and that II and level to at In we're excited kilogram, SLE to detect which randomized XX And had new with a the studies study are all our XX, in The demonstrated did baseline NKTR-XXX of baseline weeks very baseline. Lilly. cycles every reduction an were of to in results that SLEDAI-XK per in at patients Ib led X. given score II Notably, we're studies in is last lupus can day not. about of initiation or a XX X the patients by And dose-dependent the dose weeks. and our and Eli only than II in composite of experienced than colitis. study very duration. data Phase patients, from patients, see The I analysis, NKTR-XXX the Phase II day patients clinical score in studies short for Phase Phase produce at of in the treatments point can and scores. patients of planned of endpoint magnitude disease data demonstrated XX CLASI-A NKTR-XXX have NKTR-XXX planning after the much a with reduction CLASI-A, the XX scores in with the induction. To increase molecular, are our seeing we for NKTR-XXX In reduction of placebo, primary placebo is levels a to or we promising QX; because XX study what Phase after period of PD psoriasis; these CLASI-A led of patients X include on NKTR-XXX in regimen and X-week Phase exposure X. cellular study XXXX a reduction of from X CLASI-A are treatment scale. treatment X moderate patient, after ulcerative the reduction

and or lupus who by BILAG-based LLDAS. include as patients of BICLA Secondary state response response, level achieve low of the percent a disease endpoints activity disease the low SRI-X an defined

to XX, We will within at XX study and and the PK, be expect will XX immunogenicity patients. months. also be characterize completed week treated measured to The in CD we endpoints

next and agonist IL-XX program Now to cytokine NKTR-XXX, therapy clinical let's development. turn in our our

engagement research capture the in Howard has proliferation research the wide tumors. as a as of expansion of this full And the solid biology in is of demonstrated for cells recognized pathway NKTR-XXX of in the generating provides and of NK as potential of And earlier, critically natural important collaboration us our excitement. treatment you this And As the CDX because cancer. liquid much NKTR-XXX killer early is biology development Gilead. as cell. for IL-XX even both designed by memory virology T the to well community with IL-XX with mechanism is range stated pathways the cell area being know, of scientific both

on forward NKTR-XXX's pharmacological Given with program. this we multiple profile, fronts are advancing

currently hematologic Phase patients a study We I relapsed/refractory conducting with are in malignancy.

enrollment we study recently on challenges than new track. study slower little brought this sites, study is at Although and been I like has a sites, have back Phase of we'd the COVID-XX because on

evaluate quarter will rituximab monotherapy to expect We of NHL. NKTR-XXX in escalation will with into portion combination evaluate the and myeloma After with monotherapy the as in XXXX. combination several in daratumumab study in dose and of a in arms also in the NKTR-XXX complete dose first escalation, multiple expand NHL study that the will

this patients enroll We of the in expect part study. to XX approximately

the to supply we drug version myeloma this We ongoing plus pleased as trial. today And that collaboration DARZALEX FASPRO, first of multiple combination well to our in year, Janssen portion combination expect recently XXXX. are forward new in of after approved and their the for FASPRO which of daratumumab in patients to escalation Janssen. in also DARZALEX dose into cohort evaluating very entered trial as NKTR-XXX and the supply the will new myeloma rituximab report multiple we with completing the look cohort daratumumab, the mentioned, combination a May open was of subcutaneous quarter we as

biomarker Phase their the we study, and we and engagement of already patients important cell, function well cell next expansion initial populations look which our With evidence of in especially its analysis have IL-XX as on know are study, immune cell multiple on of subsets I we into NK Phase a focused week on T and We effect forward for as sharing is that details introduced I this expansion NK the of observed activation control. treated of CDX We're measuring robust program at to SITC. have NKTR-XXX the more cells. target tumor pathway,

up dose to cetuximab very regimen, head escalation initiated the of metastatic recently study or cancer XX which patients combination neck groups study refractory include will component a colorectal the combination then of early for We're X momentum to dose cohorts turn will Phase patients financials. NKTR-XXX I third-line will data we Gil a will now week. metastatic dedicated second call cancer. and Phase study to are NKTR-XXX our for next with expansion for into neck first-in-human initial our and I and presenting the significant that review The and and expanded enroll escalation the the We and in program, I/II in colorectal be overall cohorts second evaluate SITC With translational excited the highly forward distinct look at head that, with building over also from with cancer. of we to

Gilbert Labrucherie

and JZ, guidance. this no good you, still I with and ended Thank everyone. plan Starting we call, $X.X cash investments. afternoon, in On the We billion quarter over Great. and will investments XXXX our on with review in with financial and end billion to our XXXX sheet. position, financial our cash debt $X balance strong

to turning our annual Now financial guidance.

the the remains million revenue million. QX we product collaboration, of Under in BMS other related of and QX. and year milestone a muscle-invasive between the study GAAP in $XX second the This $XXX of full cancer adjuvant XXXX million the revenue. for million recognized royalties, includes start and recognized Our $XX of a payments to $XX from and milestone start melanoma sales milestone BMS million to $XX $XXX projection million million study bladder $XX

a result of reduced guidance, approximately the which will R&D stock and earlier-stage GAAP between expense For COVID, includes compensation to factors, due forecast compensation expenditures stock to is million, of other in programs travel depreciation timing non-oncology of COVID-XX R&D we expense impact million the noncash now $XX lower-than-projected and for This and including pandemic. of decrease range R&D and R&D depreciation of the certain our and due costs $XXX number expense. XXXX anticipate GAAP a expense, million expense of noncash our and our $XXX

between XXXX of for expense G&A $XXX $XX be includes million, and and $XXX projected million million approximately compensation which expense. to depreciation stock Our still is noncash

markets the to $XX on on income will interest the for our of portfolio, we be approximately now the yields due financial COVID-XX million pandemic investment that project XXXX. and lower-than-expected impact Finally,

of not significant on or portfolio our Importantly, any unrealized we have realized losses investments. experienced

And operating investments. stated on billion expenses manage still our development Operator? And closely We of focused over highly $X and earlier, of broad continue with that, end to execution and research call we I to with cash programs. our to remain the plan XXXX and questions. portfolio the in open I'll as

Operator

Instructions]. [Operator

from Our comes Barclays. from Lawson first question Peter

Unidentified Analyst

This Peter. is Waleed on for

here on we study positive your that bar Just how efficacy? pivotal here a data about in question approval? PIVOT considered be could be your should help frontline results for What just in thinking support the melanoma, would

Jennifer Ruddock

going ask [ph]. to Wei, I'm Waleed to answer Thanks, you that.

Wei Lin

sure. Yes,

I think at data of is looking really nivolumab. look control the care standard the way the we now kind at right which the is is arm, this

would well worldwide And a comparator our is and up very it's set for recognized so well as and serve basis registration. worldwide

subsequent ORR, our to based a for survival. strategy on then One approval step survival supplement is accelerated a and really So process. overall -- two followed going with based it's registrational by is we're aim by full approval on progression-free

benchmark two these looking it's So numbers. really at

this is XX%. baseline response rate around nivolumab the setting, So in

clear to That's So ORR. we than nivolumab single to response XX% agent. with XX% would like higher of roughly rate that

response we fashion rate I in statistically a that think to can nivolumab. then we have superior significant unequivocally demonstrate a compared

ORR. final package for that the -- based will approval together durable that, be safety will response on the third a enable that So profile, with and

Now approval PFS, will full that third setting. to in not will progression-free observed be, allow this X second for us ORR. were a been to on also X subsequently, against conversion survivor, to historically benchmarked that's we the gain which shot be months approval if only the And would potential nivolumab PFS but at based a gain goal,

cohort we've will melanoma fairly plus in in recognize regard to and combination many experienced early-phase phenomenal that data enrolled been were actually bempeg generally have of benefit of you our cohort, with specifically PIVOT-XX as so who And the from that the nivolumab patients with.

months prior follow-up, last the have at the earnings not we survival. reached think median call, progression-free of even XX I with

providing So be longer we'll upcoming follow-up. further at the update SITC, even with

that very certainly melanoma. survival nivolumab the if improvement III a bring would significant Phase replicate encouraged compared are margin be we of the And should to study registrational us in by of from have And were PIVOT-XX, first-line PIVOT-XX. with from for PFS single fairly all extension to so And metastatic value in patients with data data agent. huge then able the

Operator

comes from Alexander Sandler. Duncan from Our next question Piper

Alexander Duncan

bempeg and One on one on XXX.

the enrollment PROPEL uptake for to great So bempeg, recent see. is in

cohorts? particularly to curious you trial? discontinuation bit safety question attention XXX guess secondly my safe-dose a potentiate understand then going more infections MTD, dynamics and monotherapy, or how mets. escalation the biomarker whether nivo-bempeg that are example, you RITUXAN, Is this event here update SITC, liver adverse at an to XXX if little selection is the for signals the of inform XXX of not And monotherapy for due And confidence as are largely to? the identify data Just you your you dose to to won't I what's what here and paying on can the use the such combination with combination to that. the elaborate close use

Jennifer Ruddock

I'm Alex. PROPEL the first I'll answer to Thanks, you one. to Wei, second take study. to the going about And then, of ask JZ, the question you ask part the

Wei Lin

Yes. Thanks. Yes.

that care of currently patients. So PROPEL trying lung first-line doublet building to a study, plus to cancer. with study study engage hope we're as cell in as you And would pembrolizumab, pembrolizumab the know, generate end, registration bempeg the in foundation that PD-LX-positive current upon standard the is data, actually we non-small that of

experienced has extraordinarily now challenges the -- the COVID well. team And enrollment. navigated with our right pandemic the has everyone this happening, now, -- study So in really

pandemic the sites. with planning with as sites had first open vigilant as initially while we a Europe, we But enrollment earnings in out we As were delay the U.S., -- finding sites. in both sites call really, has both because shared study, of opening very soon open going, while as the really with up Europe coincided brisk. able of wave the that PROPEL in to Europe to passed, pandemic get time in And the in our we but the well to had been we're first earlier plan challenges working the some sites the the best in our initiate as and in we sites, an the the have were wave the to earlier

Its patients benefit X pembro suffering is really brought cell huge non-small -- still overall think that about to improvement with or cancer. limited so. reflects while monotherapy survival just I from has lung years a in for

for and especially And -- gotten there's a that's the and we that reflected study how therapy going. enrolled chemo-sparring. these up U.S. in are this the by sites well need Europe has tremendous and have patients still So better things in and for improved after for hence

combination standard spite and seen life of a gradual being the build upon the for to we've wonderful that see established its that patient's improvement indications. pembro to So really really reflecting of the a care and in is improve in and monotherapy that the also continues doctor extending need

about potential that enthused data to about enthused on and certainly up a -- the data III to we're also evaluating study, the next the deliver year of analysis. able Phase the follow the we're and So possibility data

Jonathan Zalevsky

Alex, And Wei. Thanks, for thank you question. the

dose know, intravenously. study. or the taking non-Hodgkin's So of regarding you lymphoma is escalating with first-in-human patients disease, And multiple this pretty and as escalation so treating NKTR-XXX in XXX, delivered we're them myeloma the part, doses either advanced with

safety informed groups the in that agent the of involvement from an for we of from others preclinical have also looking as other are experience-wise signals know also but our toxicology in terms things were that we're studies used both what what IL-XX and Now clinically.

we're expect to adverse toxicities studying same and associated effects. cytokine-related a homeostatic downstream know, because, the studying induce effects. And IL-XX cytokine cytokines, IL-XX. with dynamics receptor we're agonism complexes express also cellular at So it can key that of you responses. are as of have kinds secondary We're events. essential lot of course, And which cells those for IL-XX looking We're looking of we

of reached, receptors. you the again, can in selection. a this as of the compartment, markers playbook response And then as of we their if as functional killer dose have in asking the as changes well as can can as cellular we dose IL-XX that, in you a And it both compartment and both target assess that use engagement secondary as page a MTD tissues escalating. with CDX and study the So been of to changes, rich assess lot cell inform for well that subsets in that And assess you cells national well the with still activation, in the its well. terms blood very We're the we biomarker played, the did is, that of program not. have where has were bempeg in example, we

we all a target to confidence want. we and response So give that very, our use getting that clear inform of pharmacodynamic very of engaged things those us or have we the dose selection kind

go-forward like II of also IgGX. what quickly, antibodies clears rituximab, know, you that lysis spleen lot in case, And to of tissue through it or the tumor clearance rituximab. have when be identify when we have are a Phase as combine either that liver or fixed It you're very lysis absolutely when There a right. of can to that are we these seen expansion daratumumab example, then B happens so cells, recommended with through either in a So them cohort, dose for antibodies both when are syndrome. the with for rapid the have you going attention the pay something a known cells. We're an to

looking because, closely cellular the we'll monitoring also seeing looking ensure changes particularly of of the events kind not to is we lymphoid We'll any improve just do adverse not compartments, opposite, the in in the we're closely be substantially clearance tumors So patients blood very the exact combination closely where secondary those which in but and very be try that things. very, compartments at the at cell reside. these fact, very to

Operator

JPMorgan. question And our Jessica from from comes Fye next

Daniel Wolle

an that initially think help you Staying the neck This solid tumors? there Why is you types? to advance stated of approach tumor you a program solid you're is cancer Fye. Or monotherapy tumors. and And different combination in X opportunity well? as with then you're forward? it you see evaluate an as those as XXX, head for us in in in Can choose for ideal XXX Daniel as to going it colorectal do Jessica able this about opportunity

Jennifer Ruddock

going you that. ask take to I'm to Wei, Yes.

Wei Lin

Yes. Sure.

agents become but both first-approved in So opportunity of care Herceptin the the for we like tumors of now type breast in fact, any cancer, And in solid because antibody general, tremendous tumors. cancer see IL-X XXX was has antibody cancer. solid standard in in -- in one in monoclonal HERX-positive really in monoclonal and heme

in tradition tumor a to analysis as in space, long tumor types. the look improvement. still but really many, us there's many standard about think threw of that's as XXX cancer indications and of at of of And become what history, we cetuximab which usage antibody we remain antibody for care the develop is room the line cancer. first colorectal of to standard in are and where care as neck monoclonal later of -- how well-established head leaves So really solid within the not really still indication in And a lot line a monoclonal whether well a

it in trial. initially cetuximab upon neck in change, regimen and first-line setting moved cancer, for become use late-line cancer so of monotherapy until And the cetuximab to head And that standard care. the an improved opportunity had monotherapy. in of the use the approved back improve cetuximab cetuximab on benefit but to setting then creates while, really neck setting standard quite that brings. really plus was late-line recent a returned with a have of first-line when platinum Specifically times X-FU the -- And head eventually that then the based upon care in a has a chemotherapy while for in plus later-line then more quite pembrolizumab plus as chemotherapy EXTREME to the and of

about setting, a rate. cetuximab as in a take look XX% you late-line only If the response monotherapy has

that leaves And expand monoclonal lot improvement. so our cetuximab. cells, really the to for of MOA which ADCC NK executing XXX including are antibodies, room is the molecule so And these critical a in of of activity obviously

ADCC strongly head enhance antibody cell that significantly rate and like the cetuximab MOA and neck improve in the of the addition the cancer. the population upon response supports XXX would XX% hypothesis late-line expanding So by NK activities of

that's So of -- pursue. in of to indication as rationale one one as neck pick first of head sort cancer to decided and the we the cetuximab the

In addition, plays a similar out kind colorectal cancer. in of situation

cancer Now disease. bigger a is worldwide, colorectal much

use, Now it's the cetuximab -- somewhat divided.

cetuximab first-line a extent, with either large a fury. to second-line used or chemotherapy So setting is It's regimen. together full in

as centers a well some as as Now single use agent but investigators some in as well. cetuximab

in for of setting. we opportunity an also with So leaves benefit in range us room combine in to XXX improve we activity to move into as earlier setting, use, single-agent And due combination in chemotherapy were And to in with of an be with a different later-line the saw really single line has. XX% again, combination as in the to it's it's the to single agent a cancer variety successful cetuximab that colorectal upon terms where it well. there, agent

and combination the efficacy that well-established colorectal where setting care those and think leverage cancer to I to room MOA with the and head in So leaves partner the offers neck pick a -- in both has you ADCC of improvement, opportunity it's standard because a cetuximab now kind antibody with. bar and were use as and tremendous for out of later-line take indication reasons these monoclonal start

cancer, to as to well that this of based generate Now solid would antibodies the we neck as forward other generation proof ADCC-based combination malignancies in the this well. monoclonal expand move concept head of cetuximab concept in if in proof heme on in with move MOA after heme in colorectal as us to or cancer data tumor allowing demonstrating allow and the us forward to

to and so upon different ADCC -- think So improve that XXX I of potential types. current build of care, and antibodies is the use has cover in standard upon really monoclonal which that, tumor huge and many wide

Operator

our question Farmer And Capital from from next BMO George comes Markets.

George Farmer

yesterday. I think little there that SLEDAI could then, any different there? subgroups, are was is lupus you to But the in spread to score know XX subgroups. are patients it's that the be a for patients how the can across And good we different to going a per score but basically Wei, about get this I to bar among distributed significance be XX about It how the talk PD-LX all expecting what comment and relates know And you success JZ, and thin subgroup. CLASI-A hit, might differences see discussion bit number scoring you about these can systems? some on X would different in a PROPEL? of

Jennifer Ruddock

to? want you do Wei, George. Thanks,

Wei Lin

I'll Yes. that take for part first the Yes, question. the of Thanks great question. Sure.

important something it's So decision an that for about of lot thought we've drug. the any goal registrational decision because a development is

X% and historical the care that PD-LX then in the each particular standard above. can that's we that into know in well study, X and X% population current phase of And less subpopulations. really as cell the for that subgroups. the And that bempeg, numbers benchmark data against segments pembrolizumab to cancer XX% in For data registrational of non-small XX% early lung to population either you metastatic expression, use than of or PROPEL the we have has first-line

a population to X%, pembrolizumab phase So response a had rate at on X% really early the than less X%. of as first data the agent-based single of all, of looking

that's really to the So patients. in benchmark Right? the in X% range, population and single-digit range expect. So XX% a what that of for we that's

rate the to past is response so or trials, specifically hovering XX% the For from XX%, typically around KEYNOTE-XXX. X%

the rate. really XX%, And the finally, are so the for ranging XX% And XX% as as we're in in XX% PD-LX looking that well XX, about the we're looking at at pembrolizumab numbers of to of really benchmark from range. that looking at subgroup, a response to XX% XX% patients KEYNOTE-XXX X% data population expression benchmark then to above

So rate monotherapy response pembrolizumab. for that's baseline the

of of really data, these our I us do our help worth we'd patient design point, to study. us also data understand So to your and generate fully of these subgroups, -- at because segmenting drug be how we into to this think subgroups. And XX-plus would each have by when looking we the works registrational help

that think registrational X%. in a the against for is X%-above population less be plus monotherapy, to I because -- doublet So now study pitting mono approved pembro of what pembro than not bempeg, pembrolizumab limited we will the

think from think I I the proinflammatory because PROPEL IL-X informative generating extremely than inflame the will known cytokine data less is X% a to being However, as expected be tumor.

biopsies, treatment we we're X%, data phase that less PIVOT-XX X PD-LX positive PD-LX able of instance, X to to our meaning PD-LX in convert bempeg. for who cancer after have bladder we expression treatment our demonstrate of cycle previously to from negative, out than patients on in As was treatment, shown early just were able XX trial,

inflaming study. most cell rate, number cancer X% And we will of that tumor the really is benchmarks a of that are able really PD-LX a so through be phenomenon those as other actually think if XX% broad pembrolizumab. spectrum the checkpoint low, the monotherapy see as fairly X% to has to tumor, cyclical say, to -- the a we sensitive the because, hope be and then inflame patients, hence, I think the really a to in be if two such subgroup be in seen us approved to of the to doubling to as or especially non-small such a benchmarks inhibitor, than tumor engage as And I response are molecule in the allowing types lung pembro nonexpressing informative in the of, while in where the have know XX% low; low MOA followed is to this tumors less expressing probably demonstrate that is we would as that improvement -- we those at the number PROPEL its well X% the similar one, bempeg

that data can non-small the cell confidence in us each of upon lung at have pembrolizumab really looking have and in a pembro subgroups delivering very and that we benefit combination interpreting is improve definitely first-line dissecting that separately way, to be for cancer. monotherapy nuanced to we'd bempeg that So the out signals patients allow will them robust looking a plus significantly

Jennifer Ruddock

And you versus CLASI-A SLEDAI question to do JZ, that... want the take

Jonathan Zalevsky

question. for thanks George, Yes. the

the they're CLASI how related. about kind asked versus you of SLEDAI So

those that zeros with CLASI directly But them to so other connection, use to are of the along in scoring start the we everything autoantibodies skin. organ CLASI lupus It's BILAG, both remember, is of and and the that patients characterize the important into we they secondary by looking the and the not the patients. so the is of or on there organ SLEDAI, at And score. And since additional presence to subcutaneous involvement involvement, really scales, one always manifestations lupus multicomponent to because a accessory of cutaneous secondary psoriasis lupus use characterized linked the score take absence ranging contribute off but specifically are with lupus presence disease, SLEDAI SLEDAI the these well account from absence as or to will tissues. as their you get then instruments

So relationship. level there a is of

focused that and we the a on really in it there know Now really in particularly Tregs about Treg long-standing good is because action, biology we skin.

with currently are focus we're treating on showed treating that we're presentation patients another if in with table David's in of phenotypes application, study. and quite there, atopic with And we psoriasis. Phase patients he X Ib that that Lilly, You study, psoriasis So the dermatitis; you skin patients in large low-dose with of diseases patients dermal because other X process study in that right? showed remember of know efficacy TRANSREG a bit he in even treated studies from yesterday, IL-X of showed and

So CLASI. dose-dependent really, The we're both really extremely encouraged that excited and quite saw effect in we pronounced. reduction was

XX-point patient saw of That was XX-score the severe in the patient the had evolving one NKTR-XXX. with skin of treatment. course you As had a a reduction at was enrolled CLASI enrolled study in pretty baseline. highest dose their that over patient level that the And

IIb a one and we're Phase so information, of dose-range piece encouraging consistent Tregs, finding with we're that very and it's the the reasons main in a it's very, the So why we relationship it's dose-dependent very of it's next in follow now excited study see Phase study ulcerative just enrolling ones additional a with is months ago second colitis of summertime, Lilly. study II year. will well the patients. corner as and began the currently in couple That around in And and

Operator

comes Yang And question Instructions]. Difei next our from [Operator from Mizuho.

Alexandre Bouilloux

this Difei. on cell non-small cancer apologies but question is quick already, on This lung Alex if combo for bempeg And with pembro. and addressed was

positive And the be an the there would forward? would upcoming of readouts, strategy approval? Assuming to pathway to opportunity show in here what accelerated be data kind an you going pursue

Jennifer Ruddock

I'll you briefly comment on that. again ask to Wei, Alex. Thanks,

Wei Lin

Sure. Yes.

idea. certainly authorities. it's something -- So to a be willing I for think the -- I that in great health would It's mean we interest with

on there not robustness certainly TKI so a the on just -- -- we now the depends something with accelerated from has [indiscernible] explore health generate based of of it so the with an have example -- historically, exception so it's data will PROPEL. the we really that rate, to -- such been as the approval the like Now and response a of authorities, setting, in not first-line

Operator

next our Canaccord. Arlinda from comes And question from Lee

Arlinda Lee

the is On mechanism chose of given XXX, potentially indications. curious [indiscernible] kind presented of Treg others how to a broad about you I'm And there yesterday, sense the guys you're well? two first that the explore applicability as

Jennifer Ruddock

Thanks, going Elanda. you answer JZ, I'm ask to that. to

Jonathan Zalevsky

Yes. Arlinda, great question.

the indications Treg. So for about

indications chronic of So the the in And consider sort inflammatory it into different where of realm there's large pathobiologies. autoimmune kind breaks of mechanism. apart very definitely Treg some you can of diseases

characteristic So disease why indication in first reasons and focused that's is one a the clear of has on SLE very Treg we key a as that compartment. the dysfunction the

patients recovered have disease have in Treg that patients so from have, they less get drop much as are suppressive and then progression, Tregs less those in So especially a functionally severe the far those they active. more both they're the levels,

the follicular helper Now T which remember, David cells production. is autoimmune drive the diseases drop Tregs helper they germinal really antibody patients production, cells. are in if a leads to follicular cells that that yesterday. also antagonize which have of because to detrimental have those and leads main T about in helper autoantibody in talked you T it cells Treg, cells those reaction, And cellular expansion an T follicular same

a why Treg lupus low-dose studies those very early the of reduce some But in reasons led replicated been of normalization. one IL-X And earliest IL-X, much cases results the achieve very been so that now patients some the multiple strong have Treg encouraging a with treating those was of in to only you increase can studies. that really So to in of reported. that's low-dose specifically of patients

Treg and higher NKTR-XXX, longer we low possible elevation So of than much with levels time really sustain far can IL-X. for with periods far, reach is of those levels dose

key this why for a that's us. lead indication So is

as EAE, see of be indication disease. lupus, access, also biology, another other Treg where this lot you T disease by autoantibodies, cell that it's here, this gut also unlike lamina with ulcerative and much because known has that very the it characterized T is to Arlinda, earliest pathogenic compartments UC chronic T cell cells. And of associated And can regulating It's know pathogenic Treg was cell those highly FoxPX inflammation discovery the And with in originally less, biology, actually, of we a cell, that disease have like a the which of to Tregs mouse function disease later cell pathologic be you that's but a like that Treg, which underlying interesting coined is where has notable, is but from is the model kinds learned responses. colitis. UC. actually T you're restore the Second and came has responses a very suppressor studies in

related -- it's also So very, and TNBS a well. very important as

the covered first and II very, And very, with also X Lilly with running has of studies, will collaboration we're very then evaluating was yesterday the recently UC. Lilly, So Phase just In which Lilly, indications. just these lead be that the number And today started. beyond to with that announced that. two we a correlation Eli it's second links of indications, other getting nice struck one one

we'll be of And studies be are see two We'll other so starting, indications. different sampling and next there'll year. those that coming more

all we a strong Treg places intervention the be with disease. effect really in these than the So will controlling first different where two. to be we'll of expect would XXX, very of And have biology and it focusing scientifically

Operator

Our Jay next Oppenheimer. from question from comes Olson

Jay Olson

interpret And it findings. a cells. in had question dose-dependent would a congrats like was NK seems you XXX how the update increase about, those on And I I wondering yesterday.

Jennifer Ruddock

JZ, that. I'll take to ask you

Jonathan Zalevsky

the Yes. Thanks, question. Jay, for

kilogram increases dose So And observed highest level. level that low-level observe really we NK XX-microgram do we cells. at the dose tested, per in only

Now what the we important yesterday dove NK that we subsets. note it's also to presented was into

NK bright, of two there primary dim, that types antibody saw in very presentation possess CDXX CDXX, XX -- the They're in And those CDXX or They the And are the to bind ones why little are are of lack inflammatory are Fc there's and but ADCC. humans hyperactive, cannot so the in the they then ones way they XX occur that killer And in And what that cells. And the dim, scientists is to compartment, don't XX saw bright, bright. is saw the a bind Fc they you dim subset. cytokines like are several, the the the that because be change in that receptor. we CDXX actually, they're These because also bright of sorry, regulatory coined change our in receptors. the NK XX we and in dim where CDXX cells consider most majority cannot body. majority participate so response dim. And the CDXX lot secrete the the the to we cytokines XX stimulus.

cell that traditional of have the is that NK function they're So almost with cells. opposite a kind you the

and So that's this subset-specific delineation presented That's one that is we component. really effect. important why to that data, a Jay, the show

known IL-X throughout the we very been consistent is what point important uses. is with and learned of what's historical studied use with The other that many

much seen that, low dim of seen cells we've studies to than David in always Kohn Klatzmann subset. sensitive CDXX patients. from is that dose we've And lab, just the So IL-X studies XX same NK NK the Koreth's in even and also multiple disease IL-X in chronic bright, elevated subset the not more other studies graft-versus-host

really NK led any haven't also subset. they And We the of sequela. expansion only an cells, bright XX saw to

to So Phase be we treatment much be going obviously, of all studies duration. we'll that in will something because in our it's following longer a II,

very, to any negative at have But significance very that like doesn't look seems studying closely. it be we'll so so that clinically And all. far,

Operator

Choi from next from comes Sachs. Goldman our question And Paul

Corinne Jenkins

you hoping about was a I Paul. for talk on in Jenkins melanoma. Corinne strategy your is This little bit could

adjuvant to of about you're have melanoma. you think just more separate I all could kind combination but in a think two also how going you about indication. in in was bit potentially same combinations I those metastatic the a hoping little talk of

Jennifer Ruddock

Corinne. Yes. to on Thanks, Wei, to you Thanks. this. going comment ask I'm

Wei Lin

elaborate metastatic? X you can maybe -- different you you Can combinations mean what by Yes. in Sure.

Corinne Jenkins

week. next Bempeg,

obviously would how together development in about combinations how worked and that So you I positive pending of those was but kind data, think just hoping, market?

Wei Lin

I sorry, of part I what didn't the first were catch you saying.

Corinne Jenkins

about how NKTR-XXX in are you With melanoma, bempeg that? nivo ongoing thinking your data of the SITC studies metastatic plus and bempeg, plus

Wei Lin

Right. Right.

yes. So

So versus plus the melanoma. metastatic IO so combination nivo XXX, bempeg in it's post -- right is relapsed/refractory that now, the patient the really IO population being addressed in is to developed first-line being setting, the the

setting. build So nivolumab the -- I in really single care, first-line top nivolumab the agent nivo introducing standard by think in standard a of improve -- trying so which the thinking to there the setting, is doublet that of the combination of is care displacing we're plus really that and as bempeg upon on

REVEAL with is triplet or has being bempeg in nivolumab. IO XXX second plus a the in really a who is plus combinations or currently CTLA-X plus setting, That's which the patient XXX PD-LX bempeg, receptor the combinations X whether -- the the These failed are after our check of combination those XXX study. the program. with molecule, it think therapy toll-like patients X that are combination in Now are X/X I inhibitor combination, addressed a first-line the be being

the addition first-line combination. toll-like triple a immunity. about have combination setting, designed really to is activation progressed you're talking or innate agonist, which agent talking a innate inhibitor and agent which immune you're T of you're receptor going to agent, whether the trigger trying all about And receptor I about trigger really harness XXX really other adaptive targeting of on talk toll-like IL-X the about who a far, of cells, the response adapting PD-LX immunity would the CTLA-X So if any you these that's so ignite in a through Because, agent body's trying in immunity really the first. checkpoint try against a are whether think -- immunity a the And is fight or side, to to bempeg patient cancer. either the is address think

is the injection and receptor immunity and immune receptor to other a strategy toll-like pull agonist. to with add indicate -- really unique think -- in strategy the boost that toll-like the agents to bempeg I strategy I by intratumor the unique to the innate additional have activating and toll-like done engaging or immunity receptor IL-X on to that's like well, So And provide there's our these of that really some first really data really, really seem the adapting reignite agents is viable been to additional an others immunity. is by response XXX we what think being opportunity to while as

enhancement you agonist get also of toll-like with bempeg, immune on inhibitors other innate hand hand, and trying like the a checkpoint the which as So enhancement really, you're an response immune with inflame that's one such tumor the immunity. agent on associated you get receptor response adapting XXX, so nivolumab, a enhances by to immunity. the the and really really adding like And an the activating double

hope with well combination, the this of to IO questions. trying activating it's leverages do that that the relapsed/refractory unique really I answer an setting the adaptive your and combinations as really response I innate only Nektar that immune So as activate can both one think by to the immunity. in helps

Operator

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

Howard Robin

their you, continued studies dedication to track today. like challenging first Well, efforts hard while Their especially during these our for work to our joining incredible keeping our times. make business on thank And thank to advancing and proud. tireless clinical us me employees I'd for everyone,

a and immuno-oncology you we're stay sheet, our for hope on to And at I updates progress. our and families As And immunology event we healthy analyst forward portfolio stated their lastly, on the earlier, join we you with strong coming please throughout safe sincerely that maturing and with months. us XX. look November your of our and provide positioned support balance well continuing ongoing and to a programs, thank shareholders

very you thank So much us for joining today.

Operator

your gentlemen, you a and and concludes disconnect. Everyone, for this you participation, wonderful day. have Thank Ladies may today's now conference.

Nektar Therapeutics (NKTR) 5 Nov 202020 Q3 Earnings call transcript