ATRA - Earnings call 3 2023 | Atara Biotherapeutics, Inc.

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Operator

Good morning, and thank you for standing by. Welcome to Atara Biotherapeutics' Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please be advised that today's call is being recorded. I would now like to hand the call over to Alex Chapman, Vice President of Corporate Communications and Investor Relations at Atara Biotherapeutics. Please go ahead, sir.

Alex Chapman

Thank you, Sherry. welcome global conference Laboratories partnership third XXXX and our to and everyone, quarter tab-cel expanded with update. morning, to call Atara's discuss our Good Pierre Fabre and press announcing a results. issued we quarter financial today, this Earlier partnership our third release an atarabio.com. This at are available Media slide in press updated deck Investors the release & and section

Executive Eric Hyllengren, Chief Joining me Dr. are and call Pascal Touchon, Officer. Officer; on today's President and Chief Financial

entirety by remind results cautionary in questions. We listeners associated and company's company prepared with press then the would remarks, forward-looking today's contained with the the like to your update management stated the forward-looking release to materially company's statements during obligation We today's the be and will statements. uncertainties begin risks of filings. undertakes our made forward-looking those as company's the that call no open implied are their call, to These could statements the date, making statements for SEC These by from statements and due in or business. are qualified will these statements. differ Actual

to like to Pascal. the I'd Now call turn over Pascal?

Pascal Touchon

Alex, expansion Pierre you, our the morning. announced Today, partnership and global us all thank we joining Thank for with Fabre this Laboratories. tab-cel of you

through EMBOLD the our of for well including readout planned launching Atara's Europe. cash in initial as that value anticipated announced November with a runway together We QX this program strategic milestone early as product the building ATAXXXX are pipeline, continue extend to In into already This restructuring partnership tab-cel lymphoma. in with successfully across parallel, for us clinical positions well ATAXXX the data will we the XXXX. expanded

upcoming pivotal restructuring, Fabre After global large we pharma, of transition excited tab-cel covering strategic and This moment clinical announce with from competitive U.S. midsize Pierre to remaining across I'll details process, of the followed the by the all pharma spectrum and interest signifies an markets. evolution. expanded with biotech significant Now companies, and milestones. the to commercialize in the partnership a Atara's start partnership are in by

a our immunotherapy and oncology T of in platform. We both and our significant to potential, and cell We patients. X In U.S. now parallel, is by and structure potential autoimmune across cash capabilities, cash pursued evidenced with tab-cel, Fabre next Atara we of T of committed proven product that brings range indications as advance that optimally launch catalysts Ebvallo, reduces the successful a positioned through payments over short-term as EBV provides the life-saving and are branded from sought milestone European a the near-term a with nimble opportunity demonstrated a value, a and pipeline global differentiated and and allogeneic deliver substantial significant therapies to with years company the royalties. Pierre to deal long-term partner tab-cel, meaningfully markets. burn shareholders double-digit cell

is U.S. to them the found U.S., reach largest building Fabre in Specific to position tab-cel have strengthening of a to partnership in many Europe. be worldwide. as as adding presence which We patients possible and to committed commercial product opportunity, tab-cel succeed, to expand [indiscernible] the the with to their marketing as for is strong on flagship our their experience Pierre collaborators

receive royalties on will Now for additional sales. tiered the consideration, net in specifics. $XXX plus double-digit Atara significant up to million

upfront million approximately through $XXX potential purchase receive As part and closing and more at milestone of the $XX deal, in BLA in payment potential regulatory inventory million approval. deal we will

with development that revenues year at U.S. date. sales from agreement significant over term targeted to patients Fabre tab-cel such expected potential an could hundred pricing several and we the We manufacturing, development inventory PTLD confident potentially approval based EBV+ of its safety the for following for with Fabre who systems Pierre significant activities With BLA therapy BLA of this per regulatory tab-cel the US in we alone, million tab-cel Substantially, business the to addition, in for and potential tab-cel remain deliver care benefit the are grow purchase will value global through tab-cel multi-cohort U.S. cost agreement. future on commercialization health Atara Fabre, and royalty will and our approval potential of opportunity on will through the label tab-cel favorable transfer believe ultra-rare existing Pierre and study. expansion from the Atara reimburse that $XXX In believe transfer. patients with to life-saving future milestone BLA transition addressable significant over time peak the progressively a Pierre sales represents from double-digit a future profile. With has disease, all Atara

million for transform anticipated $XXX approximately approximately and what Thank approximately patients us you to tab-cel XX, end believe get from tab-cel to As staff expanded truly we EMBOLD QX to medicine disease, multiple both the payments cash the these in current fund autoimmune of as undertaking unwavering Atara lymphoma position be phase to will well the cash for partnership disease. on sincere deliver on to XX% levels seek ATAXXXX will all planned program Atara data planned with sufficient XXXX evolve early to organization commitment of in focused lives we therapies million an extend actions, in 'XX. I XXXX. for contributions operations to the are the This autoimmune in and we gratitude the you from commercial anticipated expenditures well next my Atara are certain to key expanded combined including would Atara innovative allogeneic for by September patient's XX%. data into well and strategic clinical as their of and significant benefits where we for today. We continue anticipated milestones, when by those partnership innovative need. The or to cell restructuring readout as the our potentially done cancer of and their by have like who's the are readout to departing continuing $XXX restructuring to our XXXX, advancing developing with November reduce as workforce reduce a

also BLA front, data encouraged pivotal have the are regulatory supports pulling different positive in the with pivotal data disclose process study our our filing initial now to BLA study and multi-cohort aligns the versions December for pre-BLA meeting data from include submission from II from expected filing in cancer QX package, support the clinical excited that assessment Phase we We're tab-cel various for EBV+ recent ESMO both plan the anticipated comparability the the inclusion to ALLELE expected clinical XXXX. the FDA of We On timing with obviously data BLA and and a to at submission strategy clear of in in latest package. I-O.

readout a Now therapy November, placebo-controlled with This primary on confirmed sclerosis. improvement analysis patients. II patients XX that transformative for merger outcome study which disability living the free of relevant EMBOLD number double-blind, or and primary multiple and will by people more than for progressive is biomarkers the to for The ATAXXX early include of includes for Phase potentially imaging track on EDSS XX the may the give impact enrolled XX, data analysis, improvement. stability ATAXXX these requires usually to EDSS have primary of part time months disability sense and the from and points on analyzed progression, will longer as earlier primary been XX XX beyond follow-up the in a XX, later endpoint evaluated months. The study which of be EDSS and at of time and assess

of potential is data allow value disclose ATAXXX in result investors to to sufficient Our MS. study to nonactive progressive goal

progressive that nonactive therapies are progressive As of right especially a approved which for vast MS unmet the patient of X% need EMBOLD therapies demonstrated is study. There is disease. active reminder, only have improvement remains significant The in majority more nonactive progressive that an demonstrate and MS. a slowing versus approved MS, focus with of in primarily disability represents population driven by no difference approximately MS, disability progressive with the the now the progression currently placebo

of is anything and to the potentially to from to than pivotal robust ranging and Phase potential up trends transformative including a of for III sets more the development better progression slowing improvement opportunities, As improvement significant clinical result, disability stabilization others disability trials.

progressing best-in-class portfolio moving assets, a are role play our allogeneic in CAR-T forward. potential our we foundational could which Finally,

term focus of development CAR-T. will following on and resources preclinical clearance the IND on clinical CDXX activities recent targeted ATAXXXX We in or CDXX, near ATAXXXX for

relapsed CAR-T for the in patients months the also enhancements. With ATAXXXX centers study are we expressing will that in are in attractive Phase the I B-cell over and potential start programs activate have continue to the or we progressing to the allogeneic CDXX, these refractory B-cell and for targets creation While invest platform value study malignancies respect to enrolling coming NHL. X years, in highest or other strategically next

half second the in data clinical XXXX. preliminary expect We of

clinic with memory and We optimized are and enrichment potential this the technologies domain to allogeneic the offer response endogenous to T for cell clinically particularly retention XXX availability as signal cells. like CAR-T be clinical less been survival for off-the-shelf to excited for a crucial differentiated which favorable cell asset of product signaling receptor, T it's phenotype associated best-in-class durability, rate CDXX responses T a validated and improved may bring profile, featuring the

pleased domain profile. tumor also IND-enabling data CDXX inhibition. potent cell demonstrate meeting built with T CDXX competitive ATAXXXX, activity, CDXX, December. this is bispecific growth with accepted costimulatory and persistence into that poster has the technical to superior against the And moving CDXX are on in allogeneic for the an XXX We presentation autologous an EBV antitumor CAR-T been and benchmark, ASH directed platform studies CAR upcoming at long-term Compared

believed the oncology, immunotherapy actively remarkable living neurological can condition. Building experience, pioneering disease Beyond such this important in therapy ATAXXX, play addressing suited early autoimmune have cell best role potential option the CAR-T a Atara At therapies results for in in therapies we of allogeneic lupus. on from With is for high conditions. interest cell considering disease. while severe CAR-T we T are patients autoimmune in data respiratory the as disease Atara, in an auto disease has autoimmune the recently of with cell allogeneic use there been in for with autoimmune

compelling requirement persistence T complex for with genetic benefits like no potential EBV Our and safety editing. favorable cells have

Specifically, we progressing which approaches. potential accessibility ATAXXXX opportunities platform to evaluate parallel with to the potential shortcomings phenotype expand of several hand, that efforts demonstrate and development. address our other for that autoimmune site they excited possess a traffic about IND can off-the-shelf come NHL that pipeline. the disease, can near in Atara soon. To that a close, actively toward are on we're To disease to provide potential memory with of of More the to in versatile term

T a result are we and runway of now of We are into with coming cash CAR of Q&A the in areas will of XXXX the primary up in believe capitalized very we can for to portfolio unmet well to call. the milestones Operator? most over best-in-class potential great planned the assets biggest soon, Atara's difference. I call of now study make our we exciting the to one the where analysis history QX EMBOLD pursue need the with turn part operator

Operator

Syed Instructions] is [Operator Mizuho. first question from with Our Salim

Salim Syed

Congrats on the deal.

if that the can. for players I involved One large were couple me, a on pharma you there Pascal, Just mentioned process. here.

curious, is ballpark-wise. potentially? How of the on economics? And first you million partner to offer could you number even sales, break one for for the the just then much Ballpark that that Fabre, the milestones curious go you that first just helpful. just important just $XXX greater be operational for put was million peak could alone indication really Pierre Just $XXX more actually what the with indication on And driven it if you? Fabre just portion U.S. that it for also just wanted out that EBV in globally? Or rationale would just financially was us of PTLD? Was to get second, down you Pierre that

Pascal Touchon

your you, Thank Salim, questions. for

big biotech. the be first development was the not And the to to the activities pharma, one but immediately about partner way over that of way key really a tab-cel. but and into Decision allogeneic was X was for the -- our in financial, have on cash us That activities, of very very and course, the the one, for competitive based So focusing of move an is in for because MS importantly, important progressively CAR-Ts. financial. over the for us us only mix aspects. to pharma One, process, into able taking cost level, mid upfront taking

So aspect, one was on financial. that

need financials because to the to that, of partner are of partner with of someone having the committed more was the as will of the demonstrating how exactly they the The other one with level cover the diligence. particular know Pierre the committed this through And success if of is truly exciting that tab-cel in and going one but course, only them. flagship they're over important And biotech it. a say to much easier adding we for are who an it And in Fabre, balance the in We having commitment they that It have having sheet. On even is point, the cost -- XXX% makes was what behind having terms and true the as taking of cash we and to Ebvallo important process, experience succeed thirdly, product top aspect Europe. in decision not it was partner then to then, one us most only their easier it's fact general. to U.S., put that really efforts manage to manage is company.

The is peak question. type indications. different million second of with $XXX your we to linked on sales, said, as Now

-- So from that be multi-cohort December. way, at additional the is there and the second-line will preliminary coming indications PTLD study first first coming. indication I-O we've in PTLD data that EBV+ presented ESMO By some in announced

So the the in product we of in there commercially. the U.S. way progressively potential $XXX build million peak that way that's sales up the is see the

your Now potential we're think a approach the to going is they milestone how the the related that we Does but on are of are in is exactly to in not can disclose potential that detail the sales -- milestone, what's it milestone be And milestone. answer indication, what of sales question? product terms and reached. just the reasonable not that sales of this we're that taking specific

Salim Syed

Got it.

guess Sort I that's if just it if rephrase I I can't I'm understand of. you want... to happy okay. But as answer, that well.

Pascal Touchon

more That's milestone. disclose my on cannot We point. the

Salim Syed

alone, Okay. of just first question. how though, on the the is And I I that guess is indication guess, for $XXX weighted much the... the million

Pascal Touchon

today a in with we like we've optimize patients been the that Europe, doing we've we where of And exactly we discussing the also, also price payers because on of them, we believe, it's potential significant several that only think try, line Atara in U.S., product in they patients always based lot a it's part I potential think say in hundred say what not we a is pricing significant first indication. the expense know the be have, care to are usually, in It difference pricing Europe for the as $XXX,XXX. take about And acceptable idea. the XX% system. But price had XX% will discussion will listed us to but don't with as to significant type between price the as Europe know what the an the U.S. and or that about is Pierre the product. the is considered $XXX,XXX we value We the with and will price, offer they giving of and price to gives that -- Europe, coverage in and equivalent health the Fabre what and the sensitivity this of patients.

saying that we're -- about a of itself, to and the we're confident about reach to million. the we're going price $XXX is this create by patients, number part significant So of confident

Salim Syed

Pascal, right. congrats All it. again. Got

Pascal Touchon

Thank you.

Operator

Our Canaccord is next with John question Genuity. from Newman

John Newman

congrats on And deal nice here. a

will in my So when you is or the update new clinical XXXX. curious, the the just data tab-cel process. clinical that regarding the I'm be Pascal, additional regulatory an could file question you give on data just us if application included

Pascal Touchon

Yes, certainly.

then and pivotal So data that when a the comparability, we agreement reach ALLELE we the study, for when cut the was alignment on organize new could study.

the to and on I-O to data independent that And December needed new October. one will the get the in ASH set time data on. array, in of us on with clean, all we're give the scans been has get so compared And review presented going to XX have patients. now XX that of the typical we've So the at

to then So the typical move new will and put set that be, pre-BLA on the of then submission. through the meeting in agency presented BLA data way, together,

But is needed confident really and the you many We're that all up confident very one about the data. with in than reasons whatever more the XXX time data of versions and this to used we've very time to data. know the than clean So in this type be the is fact the we've in patients XXX EBV+ PTLD, tab-cel different across patients in that study, more whatever PTLD. and disease process past, the with treated

view. from have we we So experience. But of whatever safety an the point package study, a very and significant similar found data and whatever results versions, the have always process efficacy

very and efficacy So -- persistence terms safety. efficacy rate, the of response and response course, over with with of of in similarly, then favorable good overall long-term

new we why agency. together about put the it extremely question? feel with this that's Does that discussed answer be confident your data and So will

John Newman

does. just ATAXXX. on had I It one question additional

be could the you're for thoughts Europe. on partnership, on being data if shortly, obviously, that if curious, discuss wondered marketing perhaps product you if Just planning coming product considered a the plans will for only partnership is own, on commercial your your here you're but considering the if

Just there. curious

Pascal Touchon

for you Yes. question. No, your thank

officially it But in indeed, different whereas is we instead with point the are way, of nonactive to Phase to indication the the on where the MS. already So is the III, discussed particular reason step depends is in we past, therapy move have -- therapy, next the to the next which if is would recently step. In U.S. nonactive agency of potential is, there is we like the the secondary and progressive as -- where FDA X in that about SPMS, that's PPMS, medical approved therapy of population, obtain when designation III, just in nonactive type Fast approved patients OCREVUS. the to mentioned by PPMS, Track that U.S., one with majority X the approved the with there slightly Phase the nonactive no X we mainly X our see in one in SPMS. And III vast Phase they offered because these in the X X they because is in need which SPMS, disclosed

slight there of So a type need status that's medical a later from potential why the as Track is BTD and Fast on.

all These some be III a capabilities very from that and we'll Phase strategic a development could and studies indications. in clinical together will X to of able these program autoimmune studies run Phase a be also So with having program benefit earlier the go in financial All discuss agency. parallel. to that maybe be significant we II partner MS stage to put that will bring will believe operational other with of

the this to be next idea at licensing in So could -- within world pure the of our same retain partnership which we've in discussed especially shareholders. this that out, and stage, value other development. co-development, will past the more activate significant particularly of in the the profit of the options being a for a that's really for of with XX% maybe for time, partnership market company At make Atara. And the the to U.S. And consider for XX% about not to aim is rapidly activities, sense with split, U.S., the to some type the but strategic stage MS,

too we pharma been number over a to will discussing big how large that. implement last companies say something type have that what actively considering So it's certainly years. of of and we of partnership the and couple early But with

Operator

Nadeau Company. next Cowen from & Our question with is Phil

Philip Nadeau

the from congratulations us. of partnership. questions A our on couple Let add us expanded

data? -- royalty range? And you of you the can of to post you a us from going see frame trial. information royalty? in EMBOLD X you on greater the your royalty process on Fabre, would Pierre Is EMBOLD those III XXX how as any give then follow-up to you're the decision a any to in do through royalty to talk thought -- What as that into the EMBOLD need First, advance the second, go/no-go in the magnitude more Could us Phase current any you of that sense terms trials? it get

Pascal Touchon

question. Thank you your for

level. our more tiered double-digit disclose unfortunately, willing for significant not the partner, first Fabre, is it's to with Pierre cannot one, the we royalty than an say agreement royalties, So us that and

that say we significant we that more So very let's tiered than royalties. deal. double-digit say are with pleased cannot And

your case have result scenarios, in significant placebo, if confirmed additional the p, Now other with ratio, that see on in could We biomarkers statistical from significant not we or we clinical p, of active showing clinical if magnetization -- be a the a into measures, case, of we improvers III. But fluid such the second CDI as a explained some versus a disability follows. terms in be it Phase very would believe a imaging we'll significant is the question, an impactful biomarkers. that top additional moving number from strong in considering by or percentage way past, of be supported data trend, transfer but MTR, different results on as of this also we as is a

having also strong this case for supported type by biomarkers trend, So additional the make III. could clinical of and a data Phase into moving

of for of So might on to have patients. to all also years' where number we -- this of to time patients will [indiscernible] have the limit of but nonactive indication larger Phase data. scenario data, the on of be able on we'll the there III be based disability to X-year on move point. might want we that a study a MS to have We'll to need example, of patients that's in subgroups where continue We III. A have stability is have specific scenario to patients a have signal and signal ability promotion disability, data X already Phase some more the the to particular positive will or stability strong of move and a we but evidence either study effect, to where type not in scenario reaching

where could could studies to the EMBOLD continuation some EMBOLD then to able or be we we So III. a for that all be of expansion could need additional just Phase to to continue EMBOLD, to other some work of stage the do lead in move that or

right evidence now a a trend is is, of your end is strong other way biomarkers by data, significance best it is meeting there the or move the that's following statistical if clear scientific probably question with agency to Europe. If to and Phase backed II and in into advice path answer something very shows there first in such study transformational be which, that will already the has of of could nobody or and large significant until a evidence a the further signal way, that that of is effect be truly explore study end. shown versus its effect, big because able to III by it So a ever Phase placebo to continue be

particular well So scenario some that work, additional that require do to positioned will we but work. are

Philip Nadeau

That's very helpful. Congratulations again.

Operator

with from Our question is next Jonathan ISI. Miller Evercore

Jonathan Miller

We're tab-cel out, I love the to would on bit guess, a runway Congrats into little deeper the, to deal. here. MS the the and forward pipeline really get from coming looking I the data obviously.

program, payments certain in And secondly, Is counting 'XX CAR-T trial that are the there. program runway? of expectations? what runway counting? And anticipated much versus explicitly? BLA covered you're how your the there For with that much mentioned the runway? in you are included cash not oncology are you payments counted trials not current included certain approval anticipated how what initiations those the covered in are And So to are of instance, the

Pascal Touchon

for you question, Jon. thank your No,

payments. approval expected approval, milestone around of number not this regulatory the So at linked of with a successfully have will payment be through from it's that, if the is in a milestone. steps deal, the terms It's really we achieved, only

milestone from million not There could way, on That by milestone. regulatory we're it's front. through approval. BLA $XXX before BLA regulatory to making Pierre includes a the only say we but the Fabre why are the the a payment on lead BLA that approval progress based approval, the milestone number that's So of

we that in allogeneic starting lupus your like doing the believe study first we are up soon because as years. It's of XX cash very runway And is is there it's question, which of expectation So that study, lymphoma in great that ATAXXXX. potential present that start, we're also as CAR-T that's very question. On this even study in we disease though for your the the X on is in now, as with competitive to XXXX, autoimmune together have for working course, now. is a we're the product a autoimmune IND-enabling to and what were you also answer then, CDXX, disease putting continuing second EMBOLD the know, -- right our exciting, right CDXX continuing is very readout, months going to studies CAR-T. And we

number many a of that have not reached but yet have already patients reached years, that we So X have years. X

So until be year, to course. able we'll next of that continue

the answer your So part is it that are all the form, Fabre. knowing expenses, of by Pierre mostly that Does the on expenses covered tab-cel question?

Operator

is with from Our next Richter question Salveen Sachs. Goldman

Tommie Reerink

This And Tommie is on for the Salveen. deal. congrats on

with do it expect more quantitative to just see we the be so too? can reduction, in values? the you will the measures provide p what closing be much could us here? if workforce walk trends Will Or December you impact So and through into any? detail in the the year-end, financial of kind And on actually more how MS release,

Pascal Touchon

second take Eric, first question? the the do take you one. I'll want to

Eric Hyllengren

Yes, absolutely.

to to it, then a be be at So deal, the we HSR -- going which obviously, Tommie, the way review, expect be don't we're going looking there's signed but the customary we there's problem. to

effective there. So date kind the of bigger December

in of to benefits the the of folks. inventory obviously, and So force, around then payment, be reduction but purchases, of benefit, depending lower upfront that the XX% the then, those severance, January, there's that's some going for payment on by headcount course, terms. And it's right yes, December, offset end early

and main regulatory at -- development benefits fully activities to begin the another XXXX in expect as the we to down as and manufacturing would you'd I look So over a Fabre. step Pierre then step main transition down XXXX in

Pascal Touchon

what we data created for the so that we to investors and be to a question, for asset. have that second value study better your And plan on to sufficient so that understanding of disclose to able said by particular far

chronic exactly But months confirmed but of to what's on number from disability biomarkers not and we to a on that [ improvement improvement, patients expect difficult the at at months the sign years analysis improving the versus So of XX, confirmed the myelination couple there it that know, the data will the see XX, the were front. primary for you presented imaging biomarker happening disability more particular, XX of stability data. on of disability Phase only in but [indiscernible] active ] will so we'll treatment. also the the months, our you say of then in the patients there on MTR progression, as CDP, because brain just confirmed that been I will depends disclose, placebo. And beyond And XX it's can shows ECTRIMS have ago XX a have XX, evaluated within be lesion be we than

So data course, type biomarkers. as and of can then, clinical of of potential that other expect you well. And of type number a

ideally, like also be particular this program. created question? and your for by answer as give product. to have what understanding the what's Does so information the next it the for we'd disclose an to And investors able to to of of So to for see step course, enough value try study far a we

Operator

XXXX session our for for you Thank Call. Quarter Biotherapeutics' today. joining Financial Results Conference Atara concludes question-and-answer That Third

You may now disconnect.

Atara Biotherapeutics (ATRA) 1 Nov 232023 Q3 Earnings call transcript