NKTR - Earnings call 3 2023 | Nektar Therapeutics

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Operator

Good day and thank you for standing by. Welcome to the Nektar Therapeutics Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.I would now like to hand the conference over to your speaker today, Vivian Wu. Please go ahead.

Vivian Wu

Thank you, Crystal, and good afternoon, everyone. us joining for you today. Thank the With President Howard our are CEO; us Dr. on and Robin, call Jonathan Chief Zalevsky, Dr. our of Research Development; and Tagliaferri, Officer; Business Medical our Ruddock, Mary Chief our and Officer. Jennifer Chief drug therapeutic Chief development regarding Unfortunately, Sandra make and on statements our candidates expect emergency.On business, call today's to Officer plans family the not to unexpected call, able including it an Financial potential due today's programs. Gardiner, future to was make for of acting and our we research forward-looking regarding statements The the certain corporate of of future success future of and restructuring statements and candidates, initiation timing formation, and of guidance or our future the regarding for the clinical the our business. reorganization, financial clinical collaboration availability of clinical plans other drug the our plans studies data agreements, presentations, data and the for development following timing expectations are are risks Because predict, many to uncertainties forward-looking statements relate which and of future, they to difficult to subject outside are our that the of control.

said, President may to results future would a these on undertake any over Form uncertainties set call filed that differ Howard from will website like webcast the actual Nektar's call obligation result be to which CEO, We the our IR forward-looking available update these of A Our I information, otherwise. Robin. developments as nektar.com.With whether at no available new hand statements, and at on or our of this and to that page Howard? of was is sec.gov. forth XX-Q X, of statements.Important are XXXX, in risks August materially

Howard W. Robin

advancing In substantial the all you thank made joining our third in development we quarter, programs. and today. us progress Vivian, you, Thank for

with our sites dermatitis. to REZPEG, patients began we October the first in of we're for on that say Xb trial Phase First, atopic clinical REZPEG in pleased initiating

benefit is landscape landscape This one for offers and about market so which the overlap eliminate patients treatment a see includes with be benefit observed this of to the data a of will market with many the in well of data us reduction this and could in mentioned and presented in dosing in the much a and need optimism an and The XXXX novelty gives in first for as we its the for his option, of REZPEG potential. strength from mechanisms, the study. for REZPEG randomized But primary multibillion we're of treatment first talk, regulatory mechanism consistent exciting EASI a disease. optimistic potential summarize the These And with some This frequent recently half positions the was this atopic Xb late-breaking treating treatment Phase is of new benefit highly the And were T patient-reported session, exciting unique landscape concept why through at data dollar biologic later we proof study plenary is in XXXX. period over monotherapy REZPEG of disruptive dermatitis that expect atopic multiple the in regulatory atopic patients endpoints growing. biologic new cells to JZ in on induction Phase the successful observed from mechanism important our REZPEG's IL-XX-based oral after for data the it endpoint Xb with on meeting could REZPEG Silverberg importantly, dermatitis.The this is new XX-week the cell study clinical new promise be the tolerated. presented Dr. sometime weeks Xb trial study ended. Phase EADV it news with maintained which treatment that another. call. REZPEG dermatitis, that across paradigm efficacy offer will plenary outcomes.As for XX many a was autoimmune This first randomized of an placebo-controlled role We substantial maintenance

still Our Xb the enrollment our half quarter, Xa projected goal to in the on with is to Phase time for areata ensure Phase design trial in randomized standard from patients. original plan area budget. the and proceeds in a study approximately study approximately XX past is in incremental Xb to of first second line patients planned this of our Phase XXXX.This from consistent studies on we alopecia XX study in this study within deliver design is track our data expanded randomized a cost its This randomized

the out and around will no study patients for opportunity mechanism. primary a a therapy. discontinuing JAK safety has in as which become currently approved experience inhibitors alopecia, to have after study.We cardiac Importantly, believe and treatments the time mechanism dermatitis the novel are treatment concerns same read atopic JAK biologic this inhibitors know We REZPEG there's an rebound biologic

for there's need a treatment medical So new high option. patients a for those unmet

on by its mechanism of the generated for autoimmune there date and multiple in advance that study IND continuing well. collective including expect REZPEG and JZ scientific to our for for immunology, data preclinical the able Treg be believe strong discuss with thereafter. the colitis shortly other to to other REZPEG action this a underlying study we mechanism this a the agonist alopecia, initiate autoimmune a moment.We our sclerosis, plan dermatitis we offers will as rationale to study With in ulcerative indications we've and programs in to pathogenesis FDA and promising scientific rationale to in diseases, year-end submit is the atopic address TNFRX also to We're for the antibody

NKTR-XXX, an earlier, therapy brief continuing CBMG that in JZ continue work collaboration XXXX. are known Duke Phase with in the are recently first University conducted our strong new to Institute antibody is program to maintaining our I'll lung $XXX announced other value-enhancing on million I asking And anti-PD-X able we Cancer this you the ended to runway planned CBMG IND submit we financial well legal with with positioned therapy. clinical milestones while into of being and we call in cash. 'XX goal positioned cancer half position pleased to for combination as that, we cash sites position.With with CBMG's remain litigation don't we believe investigator evaluate at Group, discussion. well also XXXX.Moving its clinical respond is a Biomedicine reach confident NKTR-XXX this.Since actively that while pathways study stated for have to partnership been U.S. TIL for have about of ongoing a also NKTR-XXX in to in studies in study to evaluate Phase patients R&D litigation I'll make to be Cellular of status in to advance other comment is and an the Our We're quarter execute we NKTR-XXX program.We our pursue REZPEG over a additional in to adding strategic for to and of the middle multiple our the The X the JZ? X goal clinical many the the with to on our hand Lilly, as are

Jonathan Zalevsky

lead Thank Starting program, immunology our you, off REZPEG. Howard. with

disease as demonstrated of REZPEG the in dermatitis atopic significance positioned results potential efficacy REZPEG of the an study of date and for across the highlighted from inhibitors, to of the which in and stated studies EASI This a Dupilumab of patients the immunotherapy is long was current Dr. the is also for presentation Howard that autoimmune in in response after regard.Durability during by of efficacy weeks uniquely the maintaining the result potential Last encouraged potential for IL-X-based maintain Dupilumab dose-dependent of additional focus areata. dosing abstract XX-week diseases, Through of Phase As Silverberg physician-assessed exciting clinic the multiple after dermatitis. measurements, end this atopic that for this for atopic most after dermatitis. not our end the very period, Treg is the the response end their are extended control the first to month, have approximately in a disease or for for to Time completion with has both trial EASI inhibitors. JAK REZPEG this XX statistical compelling XX% extended dosing. session observed And program for was the XX many XX and type EADV REZPEG's X onset we durability of that atopic earlier, highest level. final head-to-head after advanced congress. rapid XX induction of REZPEG of with achieving across suggests be the the induction measures.Importantly, weeks presented rapid XX the doses data for of period. reaching dose including treatment alopecia seen outperformed over mechanism dermatitis trial after This has REZPEG the JAK week patients, observed durable rivals induction at atopic responders patient-reported response Jonathan XXXX Xb action, XX-week period. and EASI XX-week control XX% of dermatitis of of these X late-breaking only at by REZPEG, of the Many areas

number dosing patients, Additionally, improvements at therapy. The level, improvements REZPEG weeks REZPEG been with a dermatitis XX what the of EASI about maintenance the big inhibitors. that Tregs the some and was increases treatment. well period were of Dupilumab historical of placebo, us as biologic Itch-NRS, significant the those total are so with studies weeks a REZPEG the XX treatment with of studies dose The of and those reasons. other vIGA, class. and induction number for clear to in were including was the weeks, above observed weeks.These continue the highest Compared demonstrated promising as XX% we with reported dose far of induction did at with X seen compared EASI were shorter which period level JAK circulating not examples biologics, arms. comparable saw XX-week atopic frequent lower baseline obtained score higher for REZPEG To improvement responses have REZPEG perspective, long-lasting setting in data some through early very dose sustained the have with typical of and results give in for only was with in group.Despite to scores, in antidrug antibodies a dermatitis. POEM. superior tenfold and numbers with in These in reported with for REZPEG, begin Treg in for to CDXXbright observed X we week to absolute the improvements And efficacy most atopic was XX has XX- induce after the to mutein as REZPEG a endpoints, there induction potential XX there KOLs all the IL-X at tolerated increase REZPEG The enthusiastic in and similar activity for than you BSA, treatment CDXXbright DLQI baseline REZPEG

Firstly, immunological diseases. relatively Treg known restore dermal to before to ability and or improve conducted, about the this pathogenesis was work little function cutaneous severity the reverse of was

antigen-presenting mechanisms and approach block diseases the Now and is dermatitis. of inflammatory mechanism employs with engages drug against hypothesis and Treg psoriasis the in areata the we to body's October, REZPEG as and lupus, its activity own the of that speaking, ThX, the Phase us such ThX REZPEG broad broad facilitate immune inducing X-month to uniquely and is and ThXX diseases, dendritic science pursue every of Xb cells. we and this observed study.Biologically biologic-naive translate Xb diversity including multiple dermatitis others. of through of and agonist demonstrated manifestations immunoregulatory attenuating for dermal differentiating suppressing system in tolerance atopic tolerogenic in atopic durability validate REZPEG, novel dermatitis begin Phase to element our a the clinical atopic We strategies in pathway expansion fostering a administration or the differing of its by cells, results have of Treg response for cell multiple dosing regimen immunopathology, restore pathway to the dermatitis.Secondly, giving to mechanism regulation study to multiple the available and believe the ongoing from central alopecia effector immune T skin. is targeting our the trial targeted mechanism, efficacy allows pathologies In dermatitis, poised atopic tolerance that treatment induces we address atopic Treg REZPEG presents attractive cutaneous the dermatitis of potential patients. in by atopic These to Treg Treg rescue REZPEG's initiated pathways dermal the

XX to period, regimens the advance induction a X-month Our from a at goal induction at or enroll a regimens XXX once X patients to patients placebo, X schedule period. for another After to of maintenance will is will evaluated be month rerandomized versus roughly XX-week once with induction continue X of dosing that meet dosages every into maintenance different either different that threshold weeks. over REZPEG

approximately a Phase and Xb We half need year. agents Alopecia areata alopecia only of expect to a in we a of is with warning with this the next high study and biologic also plan inhibitors, XX expect dosing. JAK conduct, an XXXX.We approved for initiate will or a take clinical data the and study later indication which weeks after unmet lack durability areata and cessation as black to of box early REZPEG first come

potential dermal the its mechanism great areata. Treg addressing all to novel And autoimmune we opportunity I REZPEG for For become for believe consistent and in in essentially REZPEG scalp. Treg alopecia Across and disease we a nearly and believe disease our pathologies as XXX there's different an mentioned, is action pharmacodynamic indication, profile volunteers. REZPEG of treated, therapy reasons, these of highly is predictable a just of a people even with this demonstrates which biologic in studies, that cell healthy

patients Taken REZPEG be Phase alopecia.The rationale XX to strong of together, for treatment with or we Xb to REZPEG recruit study will the there placebo. that is plans randomized moderate-to-severe for alopecia believe roughly

size of previously mentioned, incremental trials at decided while to patients increase trial it our we Xb observed treated this Patients was to weeks in indication, study a design our minimal up after Phase be total. achieve reviewing XX Howard period XX run a a will for Phase to in with cost. As XX roughly plan Xa historical weeks and of the to

improvement of [indiscernible]. severity very Our in in XX, primary percent endpoint or at salt for tool the week which this alopecia mean study standard is is

our presence in secondary antibody immunoregulatory the program. is turning who genetic We potentiate to endpoints, our upon patients contrast, body. looking and what functional to with TNFRX turn effects program collaboration on to Mary? recent autoimmunity of now saw suppressive at is salt.Now know it treatment of immunology submit the Mary expressed autoimmune and multiple conditions now properties pursuing agonist TNFRX the identified of highly holds and TNFRX a human proportion of In multiple mechanisms, resembling to populations cell selective track primary brief FoxPX IND in protective provide its believe agonist in a effect cell-based to cell of others, agonism specificity regulatory our Tregs, this will assays. has CBMG. reduction oncology program incredibly has we research diseases number program, TNFRX overall antibodies our in potential function. are and T Tregs. and type in TNFRX shown this we agonism binding, like other lead lead and TNFRX X for makes other program XXXX.And I'd is for selected be has neuronal Building and been that to for have cells loss with NKTR-XXX If exciting aggressively function associated also a in on We promise on call a including cell this a TNFRX to update that and absent, over tissues of great the validated the in with been associated us.Nektar

Mary Tagliaferri

JZ. you, Thank

suggest clinical a Cellular study, therapy as is in company, advanced not we for evaluate The in therapy. C-TILXXX. announced while do treatment anti-PD-X Group earlier, being few lung are broad and non-small evaluate work have known fully cell of individuals, clinical leading early NKTR-XXX, enhance and application study mentioned NKTR-XXX to as We by cancer cell options increase about to conducted with strategic NKTR-XXX we we our as which by continuing believe And funded such Howard recently CBMG excited efficacy these with with to to of to their respond to cellular therapies, who is Biomedicine to is patients that collaboration this With TIL regimen are improve the TIL help activity. a cellular there can anti-tumor therapies. the patients.Preclinical combination that proliferation specific IL-XX and potential we pathways. our data to are NKTR-XXX Moving potential partnering for persistence for new end, pleased therapy

Duke in site investigator at a a lead lung Dr. by first the accelerated Antonia. field, CBMG. cancer with Scott is Positive this University, of data The study partner, could leader exploration research pathway for from our to approval

a see cell the exploring which financial other and Study, by Merck for cell of we funded for continuing mechanisms, partnering from next in JAVELIN call best therapies with Our that will potential KGaA. other to year could conducted a over its Medley turn I Bladder we of reported expect unique these Phase development partner, continued and is are review NKTR-XXX.And including we studies and path combination trials, that, our the development as the Jennifer? being data our Because X with Jennifer agent are and of guidance. therapy,

Jennifer Ruddock

We Mary, ended debt cash investments, in sheet. million and with higher the balance expect end afternoon, our and projection least in you, Thank cash prior everyone. third year now quarter slightly to of this million good We with no and $XXX our million. with on $XXX at than investments $XXX

announced reduced approximately were we restructuring to reduction. approximately by our operating and The $XX workforce June. year this As in year, represents earlier San paid the Francisco-based related this XX% had million we personnel substantially costs previously expense a in reduction

realize the a this position that XXXX. annual result restructuring. And into XXXX runway with savings remains fully extends of our of in will financial middle cash a We as strong

real $XX a contributed million $X.XX San net runway in pipeline.In will leased quarter. we non-cash several our milestones impairment key through share us per take to value-generating the this which in for loss recorded assets charge Importantly, estate QX, our Francisco, for

we G&A of of and year through XX-Q, this on expect expect recognize for which year, charges XXXX. expense. X now terminated and $XX $XX to million, recognized between to $XX depreciation is includes first in million million for includes of impairment programs approximately detail which the of a being There $XX the full restructuring, to and costs million As filed stock expense million the more result, million, $XX of afternoon.We full comp is approximately non-cash to impairment our now this Form which operating be XXXX $XX of months non-cash $XX million

is still includes sales. product million GAAP XXXX million $XX to in non-cash We $XX between million range million million for Our $XXX full-year This and full-year to $XX million to includes of million which anticipate and million $XX $XX to in expenses stock revenue comp million. will revenue expected R&D and $XX $XX operating non-cash be royalties depreciation and GAAP approximately expense. $XXX between million, $XX

to interest million $XX full-year between Our is non-cash expense and million. expected $XX be

cash As will and I at million $XXX expect with to now stated earlier, this investments.And with in call open end for questions. Crystal? that, year the we least we

Operator

Jay [Operator will Instructions] And first our question from come Oppenheimer. Olson from

Jay Olson

Congrats this to the When on feedback do on investigators? expect update. you about expect talk the atopic you Can to about guidance the hearing some providing from that enrollment thanks provide trial that talk on for recruiting Phase when congrats And initiation study. rates? you complete Can And Xb study? of in for the dermatitis? you're progress, and just you do

Jennifer Ruddock

past of of comment I'm these on months investigators a that. to the going been Mary with over to couple Mary? she's lot meeting Yes, ask as

Mary Tagliaferri

are dermatitis. Europe meet trial States, different tell XX able And to investigators, from going sites We can different EASI this indications drug seen data Europe. expands industry.So And the very in there United dermal recently the that a in mechanism T for such a that reduction we clinical to you in very actually are and application I an the we following. recruit action of Berlin, XXX score its atopic and enthusiasm Dr. cells, that regulatory as the from presentation was clinical Canada, mostly in Australia. a our we widespread the Number the good any never a very I attended and attended from investigators. best Jonathan this and many one, that in calls regulatory the to with mean made about baseline, T of tell of is importance safety received. known you with well profile. are And Silverberg at trial Silverberg he years, other from dermatitis things were couple that very cells well we're atopic but very EADV Jonathan will investigators that The what improve was XX% mentioned and REZPEG, about had excited we've have compelling

in XXX regimen. monthly to highly Number the tolerable, to the the idea that drug this going topline two, weeks to hope fact well.So attractive they in are answers period of maintenance available question. REZPEG data be that time absolutely and I evaluate to and continue very now their of we Our as feel patients going investigators the and number induction in shown we've -- XX to maintenance trial three, their X-monthly half patients. on with really your patients that setting to roughly beyond able a track a like be is data will is XXXX. able to we're the first we receive and the that deliver that And on

Jay Olson

forward Yes, to look future and we'll updates.

X you talk And dosing? of thinking about to just of bar study and how Phase how you areata, performance alopecia? the oral recently can drugs Xb there initiate in alopecia And you're compare Phase a about REZPEG the with REZPEG the will On what's approved study? then

Jennifer Ruddock

take you to like would that? Mary JZ, or

Mary Tagliaferri

address I'm Sure. happy to that.

their with ability baricitinib, efficacy data, maintenance that after would things: believe and the their have, of baricitinib if that we the X accompany to We cessation at So at similar or after believe at inhibitors know, JAK the One, just We a has the with atopic in are, been very doses in see warning rapidly at hair inhibitors. XX you JAK when stop treatment an with well course, than going again, alopecia box of don't And more safety for There inhibitors. that looked convenient JAK JAK we're very and appeal effect as evaluate box or have lose treatment. the you're a we loss like we tolerability of are black you space. again, we taking weeks closely many and inhibitors, you areata.We to JAK great the hair. inhibitors, one, are to an far X problems dermatitis, the of is patients XX as patient, have favorable looking know, area efficacious. but regimen aware roughly a look rapid of different biologic black placebo And highly will profile this in seen warnings and accompanying versus competitive with think, efficacy I improved make weeks. analogous profile, would REZPEG this better without the

Operator

question from will [Operator Instructions] Goldman Sachs. next our And from Chris Shibutani come

Charles Ferranti

is on as Chris. for Congrats well. This the on Charlie progress

ones of us. from Just couple quick

update the of then scale? this we at on if still the case plans that wondering that coming that there's partnership. was on pipeline was line if the strategic had mind IND I'm TNFRX Wondering NKTR-XXX time target, XXXX on program on more on any the time an know previous the sort in subsequent and year, the the any First, wondering year-end new or for line program we for expected IND there's update point?And if partnership? expect next I a whether 'XX with should PEG-CSFX from if the

Jennifer Ruddock

on I'm first So the preclinical to program. JZ, NKTR-XXX. question the the take part have question on will of take that And going Howard you then

Howard W. Robin

exciting number Look, to So, question. Good a yes, talking companies. of a We're NKTR-XXX potentially is program. very sure.

cancer. with just with that we a a with in see have bladder completed collaboration therapy, we collaboration TIL in combination Merck KGaA CBMG You

So on there's lot a NKTR-XXX. going with

in also our Fred therapy. We running have Hutchinson the Center own Cancer at study cell

are companies So there that are interested.

strategic -- collaboration as complete we NKTR-XXX. would I like a think to for

immunology as a for in application to potential there.And exciting just collaboration as will when think the exciting company can added you but collaboration, how a CBMG get great we're we've with and another done, is now, a is you NKTR-XXX. And very although making see I give asset. as specifics focus can't Our this I progress

But don't the focused be JZ, know posted. and year for [ you I year, to get going done. that on this or keep will ] think do of handle can't that, we're PEG-CSFX you sure. we'll So it's I it say next end would question? clearly,

Jonathan Zalevsky

Certainly.

So a at the really this efforts prioritized and couple time, of program on reasons. really for our that's TNFRX we've

that that is Treg on targeting TNFRX first The REZPEG builds that's the distinct pathway from complementary a around engages. pathway IL-X

TNF strongest is ] as for one B for one suppressive the superfamily and loss that the thin signals of induces Tregs. signals expression, differentiated know critical both of is FoxPX responses, So, strong cells you example, member strongest controlling Tregs, really [ and which like and that enzyme a NF-kappa of a for also TNFRX causes of it's right?The FoxPX Treg de-differentiation

it So knowledge target advance us prioritized have at our hot into very, what and this of leverage efforts very And and built all our really that's it's TNFRX. that really off lets a know deep learned field. REZPEG also through It's we time. experience with and Treg the

say we're on have time. to on so future, focused opportunity a program. we some where finding we're had this We're and in also And biotechs lot the the received like right discuss it's but entities, focused we've program, TNFRX really companies that the others TNFRX The we really that outside have as really many at work around of allocated PEG-CSF time strategy. where that's will now.I'll pharmas for interest that with large program other into and their

also with and inhibition excited TNFRX is this we've drugs block on have paving And that And that of had something effect time, of our we're manufacturing includes cell the blocking all that TNF stage, TNFRX HUMIRA, so year into on where to around moving through energy. very line such be that submitting you the golimumab, the in our track. We all We're signaling, the known prioritizing access interest we're very on which is next and about like setting. pathway.So into infliximab, TNFRX, for rheumatology. on period like what's receptor we're about. understood IND much when we're our excited really track We're program. that just and So a missing, the profound Enbrel TNFRs, XXXX

Operator

am any Robin no lines. I our Howard now back closing turn further the showing to like over remarks. And you. conference to questions Thank for phone from I'd

Howard W. Robin

for immunology-focused Well, programs. thank joining on hard and employees work, everyone, forward. thank their like all their support. and continued our clearly path for you, our REZPEG research thank the to we development on I'd our of for And remain and I defined shareholders focused us think today, and to of we their executing efforts want have a I

us So on and you providing joining tuned, with updates look Stay progress. we today. for to thanks forward our

Operator

This concludes participation. today's conference call. for Thank your you

Everyone day. disconnect. wonderful You may a have now

Nektar Therapeutics (NKTR) 7 Nov 232023 Q3 Earnings call transcript