ATRA - Earnings call transcript Q4 2021 | Atara Biotherapeutics, Inc.

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Operator

Good afternoon, everyone. Thank you for standing by and welcome to Atara Biotherapeutics Fourth Quarter and Full Year 2021 Financial Results Conference Call. At this time, all participant are in a listen-only mode. A question and answer session will follow the formal presentation. [Operator Instructions] I’d now like to hand the call over to Mr. Investor Finance of Atara VP Hyllengren, Relations at and Biotherapeutics. Eric ahead sir. go Please

Eric Hyllengren

Thank welcome progress. Earlier everyone, quarter morning, provide financial our On you, Good Atara operator. slide full Investors financial operational and and objectives. and release a at release year key year and results will fourth quarter atarabio.com. issued the executive our and and are the Media XXXX milestones to from in today’s press conference update available we call. operational today, deck results members press announcing This results updated full fourth Atara’s progress corporate review call, on and and an team our section and also an upcoming

Touchon, Jakob of Financial Officer; Kristin Chief Joining me Commercial Medical President Koppikar, Development; Joshi, on and Chief Officer. Dupont, Global and Head Vice Officer; today’s Dr. President Research and and Dr. AJ Chief Utpal Dr. Pascal Executive Officer; call Chief Executive Dr. Yarema, are

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

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

Pascal Touchon

an joining ATAXXX progress you the the course strategic and three Thank off update all review in sclerosis afternoon. important to Europe. CAR in for our Europe sell programs. and on like and of in plan us Eric tab-cel In you, priorities the and next I MAA T in XXXX, Atara with multiple in made would thank our provide this and start generation quarter allogeneic submission that fourth for the BLA

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comparability between a a the and clinical in process differences the absence then tab-cel. each cost and attributes versions methodology guidelines, and Minor demonstrate were to pauses according specific statistical We efficacy demonstrating a clinical of on well-established impact, for experience to well-controlled consistent versions. for therapies. specific For absence based data justified, attribute. such each seen favorable for have an some extensive key the the attributes acceptable robust determined range manufacturing even on first-in-class a all as with In and is with inherent guidance viability viability, attribute, values approved key and there of based cell a for the cell specific of allogeneic already process, we key on clinical ICH applied safety few of therapy, significant

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Track likelihood EMBOLD patient ATAXXX designations or expected populations non-active of After respect the an in we for is good X XX track and the in with planned plan As this the with interim PPMS FDA to controlled Study active the to development including all-in progressive our as to to confirm to success all we placebo we size. number study sample the conducted, QX conduct an and in two patients are evaluating strategy With decision of going analysis. Fast safety we the SPMS IA progress next interim efficacy adapting rationale both in the analysis our continuing and forward. for optimize after EMBOLD with on step soon to of for blind, MS the the communicated granted non IA year, are program, the randomized, to not double of make January, Study, communicate so in ATAXXX Phase be and phase

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We any update discussions. appropriate as following relevant communicate these will

to this work discussion from large following ATAXXX an partnering interest on will IA. at on we Additionally, and pharma with we potential continue opportunities continue companies the

like MS. vaccine it focused EBV at but includes preclinical vaccine. of and an is developing to work knowledge own this ATAXXX EBV very also progressing disease we To upon the unique strategy MS between is that Our a EBV announce end, autoimmune link pleased are leveraging our

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will strategic to announce for anticipated XXX on MS pleased say month million Diosynth our We at upcoming upfront, to Oaks in in to have this about track program with ATOM we day. manufacturing Atara Last is acquire Southern close EBV also for April. and were an Biotechnologies more our partnership FUJIFILM facility which

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operation deal, we stage chain team product and and in development for the early Importantly, a will to retain assay and of technical also scale including invest process continue and after up assurance supply design, science, research, talented our manufacturing close logistics, quality phases. the

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and ATAXXX of XX now commercialization regard Fabre our position from quarter strategic of Pierre cash. XXXX, for XXXX agreement. of to fund with sale with the operation I payments common our transaction million with run fourth XX cash This our to ended financials, CAR and ATM of the you will into facility more the of shares believe a in sufficient be December on quarter the turn the to million Moving to call fourth to as XXX payable together company’s Jakob received XXX upfront the with quarter anticipated planed give includes and million of way, in stock Jakob? Atara programs. XXXX. the in will to the FUJI we We XX, T now cash over upon details million closing development

Jakob Dupont

regard were Nature, leading we trigger landmark Science EBV that which to presented sclerosis for and evidence the With cause Pascal. is believe disease. is ATAXXX, our in the recently there Thank product multiple you, sclerosis, undeniable what multiple and required candidate journal for of publications a a

terms, by of of after the EBV unfortunately, attack MS Specifically, a cells The are infection have brain with science protein it after been mistaken GlialCAM. destruction, MS sequences that nervous self-brain of and Epstein-Barr infection with only shares produce leading may of and immune that inflammation, and, MS the when EBV other levels demyelination, produced unchanged target proteins risk to scientists called but baron EBV healthy infected multiple be increased neurofilament The with neuroaxonal Adding EBV. basic or peptide a seroconversion. sclerosis. plasma viruses. a it’s of B by after In paper, that antibodies features are that biomarker occurs mediated virus identity. mimics all cells target these system both light and Serum was increased to axon EBV case the with cells system XX was how EBV chain, fold the nature detailed certain antibodies In EBV damage degeneration also epidemiological connection, proteins. infected B the hallmark shown a central the antibodies which

about very and as the findings viewed publicized, ATAXXX patients including their MS our were popular outcome. to neuroscience excited approach of in further press to for validation in well these as are EBV among improve as We target widely the community which

were ATAXXX. into been and our MSA an and March, look forward has MS published, implications investigators with as upcoming ATAXXX what of in potential the of studies noted, as in the the there late deeper mean uptake well after context by these Pascal inquiries treatment partners. As studies it patients At to we might diving in

in agreed Study, our be open as sustained X improvement first EDSS analysis with the the improvement improved were the Phase the or we’ve reminder, data, thus As patients Phase seven their the endpoint EMBOLD participation key the Recall which course months. we EDSS seen improvement we analyze extension we a XX expected look of at placebo this X natural the of stability study. end, patients that primary at of showing of XX label EDSS X to either disease. Remarkably FDA EMBOLD data results XX decline to contrary want stable, over I Phase is saw randomized XX this everyone Study far the forward data will X. have months. to sustained in Also, an XX of of the will the with we EDSS point demonstrate through encouraging To remind controlled of at interim the sustained patients, will six be the Phase

have some all of than decision. range less at making six enroll study, more the data time a durations the to at times be of will continue IA; these patients we will will than look when patients at months, take the have our months, will As different in a there some treatment six

We confidence EDSS achieving time on for month point improvement six of sustained XX% improvement is over improvement is six data, our Based XX months have Phase meaningful. EDSS that predictive patients at X achieving sustained EDSS at months. sustained

both of results two non-active studies where X a to PPMS, study SPMS PPMS the will XX% necessary planning. in a or our target and and treatment are few non-active plan therapies to the showed conditional inform improvement of reminder, Phase design there approved separate then study X EU support at determining high end study. at there’s size will and will we pivotal the efficacy. After US populations. sustained and in six the SPMS non-active limited in on sample months where dose a options end Phase we of we’ll the focus power X focus no of The the cohorts in Phase study the One conduct As EDSS Phase achieve X, very AI on

T associated for patient X. events autologous adverse our namely our of we ongoing notified recently escalation turning a FDA Memorial serious with CAR MSK the announced to in that dose the conducted Sloan treated programs, partner Phase fatal study. Now Kettering ATAXXXX

MSK evaluating on noted, is complex study process weeks in occurrence. and patients discussion in voluntarily We anticipate investigation the the case This was a As of new the is temporary an several update of MSK. a MSK paused in next basis. enrollment further following further with providing the and

technologies enrollment off the patient PDXDNR quarter allogeneic the positive impact IND an Our The for ATAXXXX temporary of falling their targeting advanced the patients generation separate we ATAXXXX a thoughts and in and which CAR not mesothelioma using course year. IND anticipate CAR enabling to of next fourth XXX shelf T currently study are therapy Mesothelioma work with underway the with for does advance this family.

all observed T-cell and which ATAXXXX has in ATAXXXX in ATAXXX. event the syndrome of and utilize Hence, safety ATAXXXX, tab-cel cytokine approximately areas release Now no with experiences Atara’s been and disease various clinical whatsoever particularly impact on or EBV allogeneic XXX patients date. to our ATAXXX platform, studies the this tab-cel no validated tolerability with studies clinical by there’s for

persistence, approach does and shown T or TCR in reminder, cells. receptor. As endogenous durability, been require studies T-cell editing, a presents academic HLA approach retains This a that of has our the the gene to not differentiated and to CAR trafficking increase

highlight Additionally, to like life with I’d our how new involved recognize for disease we with rare our a the patients PTLD collaborators, today transformational with awareness gratitude we I’d to find diseases. efforts that Day, Atara staff, patients to which other the in extend need therapies closing, are the is patients studies. and and vital Day, living my Today, which Rare Disease In and like the day in rare on Rare urgency raise therapies. patients Disease to of saving

working allogeneic with We’re to transformational need. a with hope purpose as bringing new for we challenges, as are the yet territory T-cell patients therapies. new together and committed team in to acknowledge We chart therapies

I’d Now turn to Pascal. to call the over back

Pascal Touchon

and finding we is for is on of ground this with to we in an regard the to enable I US. want take summarize with the we Jakob, what minutes FDA’s all a today’s the few Q&A, again into the the ALLELE time, several BLA, We’ve potential to has lot joining of afternoon. pivotal tab-cel you, thank And data us Thank Tab-cel a pathways ongoing on covered FDA study. to currently this you of and before At call. and with discussed preliminary disease. exploring a novel product based patients to lives from recommendation are the save otherwise fatal alternative get

We the patients to now that these access I collaboration portion the the transformative US begin FDA of pathway potentially find a can are will the call. turn Q&A we back Operator? in therapies. to give call confident reasonable the with to operator to

Operator

instructions] comes with [Operator the Our question Mizuho. line Salim Syed first of

question. with You may proceed your

Salim Syed

color. Great. indication ATAXXX in but just one for Good the afternoon, can, wanted to and and guys, release, thanks additional think for all that on press one were alluding me, you Two if I the I to confirm.

understand or not on to interim is bear like, communication the something be Pascal the stock just investors So will really what analysis the that looking going is now obviously right is AJ, the one qualitative. be of Jakob, this because data can cases that

I here. just tick could points if just I wanted So few a to through

this communicating so, a, cross it to the cross Phase least we to to data at your that indication just if this talking expect, is wondering some c, in X possible the And you come long to comparison cell communication? you. given is formal is trial the are you’re considering treatment reactivation if an that And the then, that thinking is data, with question, on publication a can sort are compared placebo? the Thank going something EBV or could RRMS for start is simultaneously going reference -- that’s IA or B, you’re to it you’re that If partnership in EBV long then you’re with a how an recent cards COVID? cards looking I’m going some announcement? trial trial the about in use of also COVID, And at these IA simultaneously platform. about of second

Pascal Touchon

you, Thank Salim.

then on start on the question, your So one. first Jakob will I’ll second

that. of what size, In related rationale decision terms we’ll say communicating to that sample of IA, the we and study, the be the of

understand specifics any the in not that have We that access depend the and the much of very and we more of IA. But the as type specifics, the we data data. the sure are to, communication clear make possible this the we’ll investor’s consequence we as the sense a at on given have of that to time will from questions readout of community

be have access And will to of from with be based engage have them on be internal have our will kind the communication and partnering try at the plan with of about part our able the potential analyses steps in IA but number asked only remark able what such on accelerated they be IAEA very forward then discussing And following line data. we interested in some will we that’s I of as and said, first you with to EMA the of communication. current and will will right to some partners the that think of access of the that and the specific discussions. only partnering access after decisions, FDA a interim in these expressed we move D. parallel, also to additional parties potential next we now to under we that decisions, data of development data, type Now, paths as work to in discussion with prepared to following to parallel is CDA time of that Then they there

best being some the is on about being is and once update the stage that, some then deal time Salim, a rationale, you which communication IA a is at hopefully the at way following on months and always discussion of the to at update decision look partnering after as and with type FDA, decision say of that, taken executive, the a the interaction to update only particular So few the is stage, a but this on event. know, takes an at some

you that that’s So point view. should what of expect from

Now the that? few AJ, want a maybe study, you on RMS say words to about

AJ Joshi

sure. me, Excuse Sure.

thinking, perspective, RMS we’ve you’re, a from something As the Salim, contemplating been that’s for while.

expect of any and As and to multiple contemplating we’ve right work is RMS type ATAXXX the across actively sclerosis study really actively of something you right fairly would are that now. we kind of assessed know, design we type

Pascal Touchon

And opportunity then for treatment, additional Jakob? the possible regarding EBV

Jakob Dupont

Yeah, absolutely.

So, potential and you thank Salim, for the here. raising this role issue COVID of long EBV of -- role

interesting, patients long actually as XXX Salim, was really by for following so And actually for story with a population. COVID suffer EBV. latent So looked know, we’ve and there you as year have or publication looking they the Sue profile lot XX% they factors and risk in publications of well long PASC health really is as was causes we XX% of mentioned, colleagues cell it up the various at patients been and of developing some reactivation that of from the late, and of high with emerging and issue a so the COVID, COVID four this there’s to found been pandemic, one becoming to underlying this really And in will interest the of January for PASC.

long pathogens control another but was of colleagues only XX% are small note unlike publication EBV things of not interesting the there you again in pretty reactivation, then of MS, it’s had So the a Gold you which with study, And where some fatigue, some of is described which driver. in consider long to and COVID compared lapses, patients COVID you the patients. symptomatology -- have see where of two-thirds of on you and have that by memory when and EBV

So could developing in. like with of tab it EBV certainly product risk like reactivation, a there where come a looks COVID there’s certainly, cell that’s long long COVID

further that and academic institutions to So in going has interesting further months, certainly position to be this of announce regarding in your been any topic, now on explore But several we’re have leading the we’re sort. with not so this discussions could this studies exploring quite query, to been academic this we possibility and for active this think groups. with

Salim Syed

helpful. much, so guys. Very Thanks

Operator

from question Tessa of the line comes next with Our Romero JPMorgan.

proceed may your question. with You

Tessa Romero

Hey, guys, for doing questions. Thanks taking hope is everyone our well.

EMA you see on The interactions are know has tab-cel, two to are materials there the exactly attributes between I and why comparability first the do for on I recent one products; FDA, agreed with? a up, don’t disagree comparable? And the confirm based could. commercial that that have And they then is the if here, specific then pivotal follow they

Pascal Touchon

Thank you, Tes.

Jakob maybe one. a question, second and I’ll First take

Jakob Dupont

Absolutely.

and through as is thanks MA has of showing the plan. extensive data to according submitted through Europe comparability the that assessment Pascal described, the of EMA question, intended process in this pivotal performed Tessa. with shared So, filing commercial November we currently between And the mechanism this studies for we review proceeding under and analytical tab-cel the between versions and accelerated in last We’ve comparability year filing one. is all

day anticipated report of the are of and Now critical approval But as assessment EMA critical this comparability XX we we the process receive, Pascal in XX that acceptance assessment. day indicates year. in looking assessment, an between versions did EMA mentioned, preliminary in at QX that

Pascal Touchon

data we we have favorable available have that key attributes safety based and and extensive for there question, and I that your robust we’ve process Tes, controlled second of for that we all these guidance, range presented values we think efficacy different determined inherent of confident on clinical of cell are and absence well specific and And And the -- the the forms. to is with tab-cel [indiscernible]. even as including therapies, manufacturing mentioned, viability the published variability for across the some in

consistent that is key clinical that NDMA, what compatibility this And minor between on demonstrate guidelines, attributes we or -- between statistical some the experience done specific on positive between Now, that ICH safety there for justified been process these and we’ve process to did across differences, few what version we well-established the no with to on methodology version. differences differences of specific efficacy the is to had and attributes we’ve attributes. have applied whether minor versions some demonstrate according we there minor clinical each and impact

So questions? Does related aspects. discussion with the to FDA is it really answer these your

Tessa Romero

really a quickly data to will that MS I just the of just on program a time helpful. prior is And question IA follow we or the or that’s how the directional trending this at no? is that for thinking the time the Yeah, you’re up question, willing here, have to at answer a as sense guess,

Pascal Touchon

communicate the able to communicate we nice about very at us specific to be say able be will time. certainly would early to to too to more to communicate. be be what exactly it’s what What be that love to able That we than we

in that the said agency, study, want preserve with the we still past, with As the especially to of for discussion we the FDA. integrity

So this on possible, the specific again, give within as the will context any next but more be as cannot our to as our intent at be we stage, communication the specific of following time possible, clear our at as IA. step

Tessa Romero

got much, Okay, Thanks it. so guys.

Pascal Touchon

Tessa. you, Thank

Operator

next line Canaccord. Newman question comes John from of Our with

question. proceed with your You may

John Newman

the question. for here. Two questions Hi, thanks guys, taking

ATAXXX. one first regarding interim for is the The analysis

number months, XX moved have assess be or based beyond prior of least sustained at months, that comments able to six on also Assuming that for at internally, EDSS nine will example, you will have six but certain to improvement you months. patients

to partners Just and those able at the with data wondering if be FDA. will internally least shared be

still there you at be may you the just data that do Second method where FDA or adjusted giving now material? Thanks. the in clinical could that analytical a the commercial with are question comparability have I be considering point believe additional differences on you are tab-cel,

Pascal Touchon

about take will answer first communication more I one, second guess. the you’ll which the Jakob, I question, Okay. is and

under of John, you’re confidentiality as the to the of months, will it’s of and to FDA agreements the going indeed, that intent we So or the predictive even data to a study. from think month interim the whatever months, is analysis. the the determining EDSS will XX have communicate though I say the important that XX, ultimate main of the to question, is XX potential because first perspective up improvement partners, something even is to overall well endpoint criteria power selection as XX% study patients be positional be on terms for right to with number And the six that the on of a at in X,

objectives help NPR communicated part put also to data partner the groups particular to on potential of different access and a as some with as access different would of HIE get will will us be to we and to well CDA. that under all two the FDA together biologics and to data [phonetic] package has with markers, of organization to these data Now that

plan tab-cel, elaborate bit the the paths Now, second for maybe question our you on on can FDA. alternative Jakob, with on a

Jakob Dupont

absolutely. Yeah,

So, thanks question. the John, for

interesting. proposals trial. clinical very be where questions will upon made answer the to than We’ve there that FDA the and here position additional that will what ways agency, time due that doing that had a we’re those to also we new FDA believe Type have, are the embarking within minutes recently asked we additional we after meeting the the series on of B and So for we clarification a final with questions the agency other get rather

So range we options. have think a we of that

We proposals are resolve other series we’ll also minutes with think FDA. a we the And dialogue but made to those in of get official we’ve could issue. FDA again, the this active that

Pascal Touchon

particularly, worth come here, aspects effective think establish in that I said, we we and your a safe more for back attributes. discussing data. acceptable have, we are One that John to are think, values of range as that And each there different is question, to

a want have we based ways establish key attributes. of of commercial experience specification support we discuss and a values with different range how product. And So specification to that to product clinical to the safe will effective the of on establish

proposing products clinical the that way is We started a data. patients, to And a clinical it to great course, questions commercial do also adding we of treating generate further have answer data including by about product. the in commercial some another some continuous address monitoring are generate which have may data to of we which to way your setting, already post-marketing question? Does be adding also

John Newman

you. thank Yes,

Operator

line Nadeau the with with and from Our question. of next Cowen comes your proceed may Co. Phil question you

Ernie Rodriguez

our was new This reaction this in or have call that a mind analysis? it for a question. to the first Ernie the Hi. FDA guess for Thank from is you or Rodriguez a change -- I our clarification, taking decision Phil. I was did

Pascal Touchon

by with recommendation clinical So in was, and that unexpected. fact, trial as do preliminary to surprised agree said, were suggesting with a it commercial comparability a they We I say product. not

FDA. past given for quarterly of the surprised during commercial because, wanted equivalence, aspect comparability notes the to power throughout We see manufacturing on more confidence XX% update and in wanted, have we pivotal are demonstrate by data are see that fact you and very all our regularly product know, we of [phonetic] explained portion with initially, interval between very key transplant that say statistical on FDA to submitted to each We’ve with as few version they with batches. quarters call a then that this they the our the progress

also with the for the IND questions, total then for guidelines. answer we we B and CMC loss [phonetic] questions perspective Type meeting statistical to we of end October, B data, we these the but ID rolls presented FDA the we vast book that of all putting these then at data to these only asked are here an of meeting, together in had produced. represented amendment the data another that all in And we very And comparability where recent bushing only then majority XX the the analyses, the analytical additional So all on the in ICH additional provided not Type according put clinical not year.

always and So in to clinical quite correlation PTLD, you of and on I FDA that thought XXX an demonstrate which data data cause is comparability EBV+ been some that and data the XXX because and but with amount we remind data reaction the provided than disease. the the terms answers the in more analytical the than of is very ultra-rare safety, and linked the versus terms clinical to consistent has more efficacy and patients the treated we with their have impressive we of time, for debate going questions both were with

with. amount their impressive to of why the were quite see it’s preliminary So That’s very of data position. we them that surprised we provided

Ernie Rodriguez

product rationale because commercial decision product? patients studies, And how their different for that different is decision there? the the allow you with What’s the commercial current that behind you’re that use to to treating agreement than or

Pascal Touchon

it’s It’s when a patients out be different when a that -- to process. to to we them that different IND product something you through but treat has an able process. right ask commercial amendments. I But point been to mean, you’re as interesting, use a

provide or view IND period we they they don’t certain So treat can if amendment patient data usual, a time, an single of use react to and as to including within you the in patients. when start and treat patients they we started them data, approved for patients that patients,

course, one which been So for of there comparability that this parallel process, in FDA. of process filing, of different the different type the think, I process, is has is, demonstrating BLA and questions a from

this us on So, have allowed commercial think because patient they agreed of on be between they accumulating a that that’s the with we comparability efficacy and at hand, product able commercial data and not on stage. treat pivotal commercial are of one safety and I to product; very hand, important terms to other in

Ernie Rodriguez

and, they how about can may are clinical study, they Okay. details one, study recommended recommendation I that give sorted will that any preliminary And that you what you guess, require that mentioned one [phonetic]? decision, final quick confident they be a

Pascal Touchon

are these do such there study, proposing what we the that. product as key they as based identity BLA in that commercial the range alternative are through to questions dialogue as this to program? all said, on trials stuff as we well ways BLA of an think we the a have submission, us various the attributes, that with expanded discussing that elements data commercial rely to clinical related submission because earlier now the active from how well and in and with for on clinical no, proposed you them But to mentioned pivotal answer we path other as a the other Yeah, have are data on the ALLELE new on is that’s of acceptable clinical accumulating products are upon I will a establish specification we access FDA dialogue values

Ernie Rodriguez

Okay. Thank you. And good luck.

Pascal Touchon

solution. FDA active an and is for a look with to find dialogue, the forward It further we collaboration

Ernie Rodriguez

you. Thank

Operator

of question next Ben the Stifel. comes Our line with from Burnett

You may with proceed your question.

Carolina Ibanez

Burnett. you could the I Hi, share, level use occurred well, prepared plan this that serious If validated who the died? taking Thank in cell provide you you. next Carolina an you rationale remarks, few you for the fatal in this treated domain weeks into update in review Thank you the XXX the the Ibanez events adverse patient point, stated of your of such to in you X co-stimulatory is more constructs on question. your for of in Ben our Phase that understood this the event, Can behind a as ATAXXXX. at of fatal CDXX. context expansion the therapy of And study of investigation

Pascal Touchon

Jakob, do Carolina. you, these address questions? want Thank you to

Jakob Dupont

absolutely. Yeah,

getting information So coming that this with workup obviously And doing this course particular of be Memorial we communicating are is Memorial on we will on the the weeks. patient the for Kettering more over Sloan patient.

updates for further have in will we So you this regard.

on FDA duty As supported FDA us information and FDA that then with temporary the their shared and put the hold there. we they and mentioned, here and they Sloan enrollment obviously decision did Kettering the or a the they has with

cytokine over particular well, things Now we to as like and expansion forth able the we’ll of are and be but profiles patient course in coming more data getting provide the detail this so on cell on weeks.

Pascal Touchon

using a domain not because that’s contracts CAR the mean, to the that I know, is T T. has Atara. related been licensed CAR this domain, that already a case different stage XXXX, autologous to of used as clinic. this the this as And well was XXX And program Mesothelin co-stimulatory for in in you been allogeneic as something, exclusively we’ve in in

investigation, safety case requires the the case about clinic a heard has programming know unfortunate aspect are that probably case clinic. licensed Takeda to this some Again, confounding also You patient with far, to Fate this with in and been safety other Atara, program and any a XXXX it’s addition with there not domain of we’ve factors. with very many complex this because issue of this further to -- in so or program

understanding. way and way our a at that a understanding communicate of a we It’s good a different will in the can very to we time have we deep unfortunate MSK. aspects fourth factors, need in these when have a case, about do that patients with we these lot proper make partners And about of line particular advanced can treatment, confounding of conclusion of MSK cause better communicate a in complex So very we very better conclusion and and potential need events. before to

Jakob Dupont

really next domain Zeta And vivo just regarding to X-XBB where expansion. advantages do comment per persistence in more which co-stem or a co-stimulatory over other of believe in is behavior CDX generation the cells one of construct has that se, terms of that this CDXX, we XXX, domain

CAR of cells to the the of phenotypic first the T are Some aspects relative generation. really favorable

generation So we Sloan advantages think Memorial Michel Sadelain first that the have Kettering at Dr. particular from constructs. over really does some this design

Carolina Ibanez

perfect. Yes, Understood. you again. Thank

Jakob Dupont

Thank you.

Operator

last comes with from question your Butler of line the may proceed ROTH Our you Tony with Capital, question.

Tony Butler

would XXX, Wouldn’t that That’s standstill, just utilized? at just being and/or sufficient, in either some for at or as to very guess I’d patient therefore then a is, didn’t is FDA to not safety question example, in question solve is comparability that there a confidence have questions you with progresses product agreeing product, That’s efficacy Thanks Pascal. to I the how very The much. difference And the this much, level or that what be Thanks the that in least commercializable which affected commercial is the of strikes in two tab-cel notion on one. get assume longer would b takes of time? be gives product me the would imply not and it be that ask newer a would be solved though, the light way, the rapidly any part cohort part true. expansion comes I at agency? and

Pascal Touchon

Thank will first the you, take question. Tony. Jakob, last you I the take one.

Jakob Dupont

Absolutely.

disease, versions. The lot we set beyond we We see organ has the a that background. release have safety Sloan very experience. versus host saw patients at ALLELE and Pascal the We clinical cytokine is efficacy don’t comes good. syndrome. where that of the EBV+ PTLD. response is this, process program Kettering good. We have there. once don’t years rates mentioned no fatal other of patients that’s are say treatment the a these ago at high a this ASH, disease. We for profile pivotal and will Memorial data, graft XXX It’s you true robust through now treated quite that And quite outstanding over really these patients with I options, with been of academic really across Tony. at you XX% data durable rejection. we as ASH, And some And if again, Atara that response. various you, really at thank clinical XXX see really actually this patients don’t So treated look see safety over believe the see where cured

clinical various what that there data. in And the for is process are there specifications consistency great the so and versions know we

it’s So very believe assuring we a set. real data

We they EMA come mentioned, to also, the of preliminarily conclusion as have this to comparability. and have well data as submitted

and this again, believe high important an dialogue do in we quite in the therapy data as that BTD FDA. is think clinical this consistent with a So focusing We the population is on unmet very it’s well. really need active

here went as studies. expanded in that patients we IND December on are in mentioned, ALLELE, very in And, also with through of we mentioned, the you this And the treating exciting mentioned, the as of that product, the actively also product. commercial access, one patients so of, clinic think with did last terms And expansion we on it’s Pascal cohort year. have on of FDA the the commercial XXX

So reassuring active is able are is data that proposals And that provide this we this of discussion. this the continue as Again, area making very again, the these alternative well. our types we be we we’ll to that negotiations. think as FDA to of are a

Pascal Touchon

XXX of attributes with of the is data commercial the something commercial key that add products. already for important we significant been product, have treated of are to EBV+ level data have had different introduced XXX key values been Among mind plus on I PTLD, patients part in been for there XXX have among Tony values that having attributes. the tab-cel clinical patients with clinical the that have accumulating that to -- And different tab-cel. That’s patients top the now have the more with of than

that trench So that trench. the and product we commercial is have within

experience value forward. but with attributes us we we different that confident way have So a possible what makes clinical the that versions, key of of find safety. That’s and specific already efficacy shows extremely

very we and versions. is different First changes many questions over is been your these why process no of minor special do particular tab-cel, all, developed case, Now, and versions impact there have on has again, there is it on development? many, think these been across years ATAXXX those

the it, if version same are debate and If two. that you commercial, have pivotal we think the about between between process about comparability we won’t

is that’s that plan ATAXXX possibility of for Phase X is in So have to to used the material same part what as our process supply. in have commercial

how we’ve may this the they have in aspect learned better The a and -- that moving of some product. of interaction questions other lot the forward to address how to future with know the for FDA, we potential now new

answer tab-cel, this be extremely it this and on right So the us should which question, having of for is and debate learning and pipeline. your [indiscernible] have case very particular specific the also now X ability FDA makes confident on a Tony? think ATAXXX supply I not this an with that Does Phase again, issue comparability rest commercial we’re to the

Tony Butler

Thanks you, Jakob. Thank very Pascal. sure, Yes, much.

Pascal Touchon

you. Thank

Operator

Atara Biotherapeutics That for Thank year and results fourth conference concludes quarter session financial call. our you question joining and XXXX answer today. full for the

lines time. rest You the Thank enjoy your this for day. and participation you of your may disconnect at your

Atara Biotherapeutics (ATRA) 1 Mar 222021 Q4 Earnings call transcript