ATRA - Earnings call transcript Q1 2022 | Atara Biotherapeutics, Inc.

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Operator

Good afternoon, everyone. Thank you for standing by, and welcome to the Atara Biotherapeutics’ First Quarter 2022 Financial Results Conference Call. [Operator Instructions] Please be advised that today's call is being recorded. I'd now like to hand the call over to Eric Hyllengren, Vice President of Investor Relations and Finance at Atara Biotherapeutics. Please proceed, sir.

Eric Hyllengren

operator. you, Thank and Conference everyone, Atara's Quarter First Good welcome Results Call. XXXX afternoon, to we release Earlier quarter a issued today, press and progress. financial announcing operational results first our in updated This and at slide the Investors deck atarabio.com. press and an are release section Media available call, our executive will On and upcoming update key members provide progress operational the results financial milestones our and from and an Atara today's team on also review objectives.

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

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

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

Pascal Touchon

and which and marked recent momentum by the medical, community. and in landmark build and have for leading trigger you in progress for and EBV as significant where start awareness Eric, interest you, multiple this momentum good therapy of exciting we continues all ATAXXX, MS made cause first the thank drive us transformative investment with scientific would quarter, the Nature afternoon. potentially Thank to in X this and This to continue joining around publication I of was program. our Science, to like sclerosis,

in EDSS events follow-up. successful a months an EBV landscape; confirmed clearly in MS. and a improvement March, highlighting the patients establish open-label a majority ATAXXX; we as MS either a XX with conducted we to lives covered of Phase or have importantly, very and cause and MS; for Day unique say I value overview stability treatment in as demonstrated transform in up and ATAXXX where addition, of to to more a In have that paradigm These of disease extension data, its potential the Jakob will EBV history updated MS patients' creation the of moment. opportunity

to Looking study on the interim June. II ahead, announce of EMBOLD track the in to we pleased are Phase are that analysis we conduct

As order of the the whether conducting by a decide achieve size reminder, of should end or goals sample to to IA the power are, increase not we the in study. conditional target the the first,

development MS. well nonactive nonactive steps so Second, further for companies interim will ATAXXX’s we secondary in to and FDA ATAXXX Fast it accelerate development that year. we the And progressive and the decision Once We partnering right for our Ultimately, our In pathways creation. design, potential progressive allow primary very are starting Track size data indications. completion, lastly, with partner and designations discussing with under will and the be studies on data decide value the to Phase new it broader July potential steps for II investment. FDA used our MS to plan biopharma for discussion far. rationale both in study to behind discuss plan parallel, intend development planning inform including Phase analysis inform Phase plans, III the us data both and will IA to timing, timing with analyze III decisions accelerate finding progressing expand and and communicate from next then and preparation, this sample development the of we

to now tab-cel. EU and in our on FDA update our the would continuing U.S. MAA like provide in an I the Turning to dialogue with

to approval this a year. regarding and in expect tab-cel decision quarter First, European of Commission fourth we are the track on continue

with address As part review We our additional European we Medicine EMA are to XX the to which of will review day Agency, our list for requested answers adding to an of additional questions, preparing answers the believe their ongoing days time questions. process. EMA dialogue recently sufficiently their in XXX the results

of for review standard additional need assessment to result a time, their EMA transitions line. a As time tab-cel

of to QX However, even anticipate after this this transition assessment, approval continue EC we in year. standard to

in Looking have and key inspection recently for we say conducting are that confirmed. to pleased EMA, review pre-approval dates is regulatory the pre-approval been the step a ahead, inspections with the

making looking with to and are inspection forward good progress completing We soon. are EMA this

In to have filing. through addition, as comparability previously noted, we have been data MAA our submitted EMA

received and commercial the now comparability demonstrate has to sufficient versions EMA Day Report, between data clinical have comparability. process We manufacturing Assessment and the considered XXX are Critical EMA

We look are and forward dialogue EMA. further our with with to pleased progress

front, On conducting enable the a regulatory a filing without the U.S. of potential Phase to new actively discussing proposals we BLA are III study.

very tab-cel leveraged of few and a weeks months. few as an median a status product, BTD urgent addressing medical to PTLD life in no need expectancy therapy and patients ultrarare approved a proposal our has limited second-line just a as Specifically,

the We have proposals FDA. made to several

only meet our commercial from of range lots a coming use First, specification lots. to used clinically that

XXX attributes, more values the establish, effective commercial believe, Our extensive of product and clinical specifications. data range clearly determination of product we patients key safe in EBV+ acceptable for enabling with PTLD than

study. a current the commercial an Second, we in generated additional studies Phase the to use filing propose being support clinical III without data as a way to with product

the and BLA propose The in approved patients few will setting. expect filed FDA on to U.S. reviewing to an confident proposals, appropriate that I a a we constructive of our we way find post-marketing is provide months. clarity tab-cel monitoring pathway Lastly, next further the to in we in feel a continue and get potential

Technical as updates. and operational Charlene process manufacturing we quality, and Officer, month, development, welcomed science, process to Moving financial supply. to Last overseeing Banard Chief Atara

at from also successfully cell and going is our The manufacture fund fund XXXX April facility completed strategic and million with the planned sale to transaction ended with with XX, our as closing a for our the of $XXX believe as quarter We clinical- plus expenses received to of of T operations into quarter to XXXX, the the give commercial-stage We more turn position fourth $XXX Jakob? partnership company over and partnership Biotechnologies, in ATAXXX plant to the for cash. is reduce will million I of cash very you we call approximately the cash began manufacturing With T XXXX. to the Atara capacity the the Diosynth to access development on and million $XXX multiyear or well, FUJIFILM in be flexible CAR will of operating programs. therapy. FDB FDB to over transaction March expected allogeneic the first period. regard runway, sufficient publishing or now FDB, Jakob to details

Jakob Dupont

as and a Pascal. publications. by is the sclerosis. awareness of strategy note, that were QX a threefold Science targeting ATAXXX, longitudinal year, neurologists cohort survey showed versus the multiple of in results XX% from high-prescribing This in and EBV X the a was prior was survey of therapeutic viable publication to of agreement following increase awareness conducted a the has Of X as last With momentum increased was surveys weeks continues as and which conducted and Atara Nature and to multiple in identifying cause regard Thank Pascal landmark EBV parties sclerosis. trigger well. to Science Nature leading ATAXXX mentioned, by you, external studies inphysician and build following

with transformative potentially the the of During changer throughout stability EBV confirmed that high-dose months for with patients a EDSS cohorts Phase to were in continued and improvement XX% Phase grow if improvement our have time of show our open-label observation XX% that recent XX or note, their patients. Friedman, updated achieved the Of II, to MS up EDSS this presentation and product EDSS extension Mark study XX we data XX% of game improvement momentum ATAXXX Dr. EDSS XX to that in a point. confirmed out MS I have for of And patients would at in follow-up. XX-month one to Day, experts, confirmed of commented the demonstrated either had

are excited therapy to to looking the this potential EMBOLD the about help for forward results study. patients the and are of We very

size I as we include ahead, IA The EDSS to Looking achieving like primarily to EDSS endpoint is This EMBOLD XX% June, confirmed IA and planning with at which clinical everyone XX based best or the interim would adjustments improvement FDA. will improvement EDSS greater by III was additional of found Phase I X confirmed any magnetization including and study. will inform the longer beyond The include transfer also as conditional biological by also for end would whether sample to Phase IA needed broader months and such the X inform be the months. predictive of for to will data design than duration remind development, of on that other indications. determine improvement biomarker IA on prepare the MTR, focus patients target primary XX power be in other of EDSS at achieve analysis biomarkers. at been the months, and months, the the Results endpoints II will will agreed Phase II data, and study timing, which has treatment will ratio, various improvement Phase this

of XX expected enrollment patients the conduct soon interim after is a of our As current reminder, analysis. target the

you size we decision decision rationale As to communicate Pascal the decision mentioned, on in behind both steps after plan forward, and and July. the to we make the our sample

like not by now conducted recent Based adverse pending, Kettering informed by investigator-sponsored update and treated to regarding the communicated we our amendments. Center of an ongoing intended are and in the partner, that This caused I'd the available MSK Cancer assessment Phase in our MSK-conducted Sloan Memorial in called I and assessment and programs. ATAXXXX. mesothelin additional are trial. autopsy consent of CAR candidate results developed independently to will being any to Turning being is to studies fatal final date, and/or is on Final ATAXXXX. autologous protocol series event be to information by addition provide the determination made believe T death The patient our FDA causality our by the MSK. a product

As a new reminder, patients in paused voluntarily the MSK of study. enrollment

data half for receptor year CAR PD-X-dominant next-generation patients and is advancing anticipated provide update QX CAR targeting Atara program, the to work for separate well off-the-shelf therapy the through ATAXXXX using this technologies expect Phase I second this filing other Additionally, in with our IND negative T this year. and partner, of for a mesothelioma mesothelin for T ATAXXXX, MSK Bayer. advanced XXX IND-enabling tumors, with a in allogeneic and solid of

This receptor. has does Atara's editing studies shown gene T CAR not tracking to and the and in HLA Importantly, retains academic been durability approach cell persistence, or of TCR endogenous the increase T require to CAR cells. T

are wholly CAR In addition, of best-in-class program, are T, ATAXXXX well. CDXX. this B-cell track in to we advancing we submit for allogeneic Atara-owned an QX as And malignancies on IND year expressing the potentially a

order a in products For from X approach design ATAXXXX, to manufacturing we implemented differentiate it targeted factors. have and essential existing through

approach maintains our TCR. endogenous the First,

are cellular lymphodepletion. delivers a for exhaustion. we enriches persistence Second, co-stimulatory utilizing to memory extensive our central T And domain cell need prevent and approach the in cells vivo for XXX phenotype to third, expansion enhance that T the without manufacturing

the not longer approximately the response data CDXX that potential the for believe on higher in of cell believe best-in-class as response this a ATAXXXX accessibility. expected XX% high to rates CAR the CDXX-directed of address be complete safety therapy. the that thus off-the-shelf we at far the as CAR the therapy the do program X the medical achieve unmet We patients well differentiated has response of been T duration months a based existing with and who need cells, potentially potentially could Given T presented EBV has space,

to to bring Before I gratitude like T the we of involved I therapies to need, Pascal. in Pascal, to you, hope and extend our would to these in patients with cell Back back allogeneic our potential. my to patients staff, curative some collaborators Together, Atara turn studies.

Pascal Touchon

and you this for afternoon. thank Thank us you, all Jakob, joining again

for I'd FDA end remarks with June, weeks, further unique a begin analysis After to I key for Q&A, and which, interim like prepared this a am truly communicating in Atara therapy ATAXXX, we and the our an exciting MS. we achieve in partners. saying personally to transformative time Before by this further look my July. potentially for is with will potential just biopharma to excited few forward you in discuss with with milestone forthcoming

creating at of now staff call thank look operator would turn to to the call. work these I Operator? value events, company. the their As begin I'll in to hard all forward for Q&A patients I portion Atara the the like back the upcoming for to and

Operator

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

Salim Syed

for Just ATAXXX, me couple a I can. on if

people this we're this of things but an mean going readout. lot a be adjustment and seem of IA We're Pascal, around can interpretable get going not a to So going lot to size here. rationale that to to rationale, get think a different is sample

whether catalyst? share our follow-up. for lot interpretable right, curious will will this, a then put or about the a to shoes, looking -- this you guys this an more internally, going to external, And so we more things if there you that right Or be way can less investors' interval were thinking yourself have as And guys this be will just have a to shoes in make here data? be second, you I'm but is an are to at I or is the should that the it you that

Pascal Touchon

would understanding data potential said, develop for fact of today which to also potential you say that the be will we of shared important Salim. the to a But at partners investors unique could question, what depend the is end this the as then of of for able reason the but on on potential investors disease form so can to we is July don't the for medical timing And be the in is the likelihood way to this something to that program, is The we But size, not if that and you about success to later the them different clarify impact the very for your many successful what value been have believe think coming study, an this be know, clearly the very Thank a to of is their the we with on reason in have that about to sample will therapy the allows as disrupting rationale product. that creation timing further lot of the can I say biotech will specifics to the give going very also completion own development. information intent industry program area giving in potential with not far back communicate further it steps that rationale, FDA only also data. of because know unique. program. you of you unmet that need. to give they create is further of rationale be ultimately that view for the important I so that it value. of This like a relevance our have

important study. that believe, for program. need form information their of focus mind view sure to II of damage to our however, an own Phase value, make what do But again, we the likelihood that to be to on communicating, have, success value. we integrity creating not the of that We we And will on be -- create we'll that study investors

Salim Syed

study Is out the at qualitative Or guys out here possibility assume cards to or that, of the the break I somehow readout movement? benchmark that it or is you you here a MedDay would it that there -- of to would put that when point? the integrity thinking Phase you are the data the placebo that this

Pascal Touchon

as intent the we're clear particular taking -- as able of completion about possible the size is study. We timing to the the decisions to that why our be and be about of

But the integrity give, want the study. same more we details of the I the can preserve understand. to at better So the time, we

there thinks of about potential how why success to before because the be by for making is stage. an discussion are further of this decisions believe we the that about about we likelihood the qualitative important going later the that something of give management program at partners confirmation data a particular is or aspect to investors that it going is interpretation the color of we'll with So idea give

that with arm study. of about placebo studies possible you much we the certainly much as how the the today been I the are we like with as about aligned So again, previous you is we'll but MedDay's or give confirmation seen data will to, confirmation cannot preserving to detail studies Phase has details while try the what give of referring say integrity

Operator

comes question Tessa next JPMorgan. from Our Romero with

Tessa ThomasRomero

assessment? occur So of second given between Europe for tab-cel our color our be the the the standard study? disclosure of to can bit one, then approval you just ATAXXX. shift to first the interim What you expected a don't question one on Atara EMBOLD think are to will and more activities impact provide is a an why in at And the on there

Pascal Touchon

Tessa. first question, and you take want Jakob, second AJ you, to do Thank one. will take the the

Jakob Dupont

Certainly.

Tessa, question. for So the thanks

as tab-cel And time described, the company's questions. our transitioned to standard mentioned, to So to questions. as to -- we responses the going has be those is EMA this Pascal EMA feel agency address in that review. MAA able Pascal answers additional allows also to this But the confident review the we're to

is that result is the is But that we're still an important track approval XX most of on So that seeking. just EC extension target year, really in that I additional days think thing this the we're which of the QX for the for review. here

And So in we're goal. essence, yes, addressable. ultimate standard still for on our review, very track

Pascal Touchon

Tessa? Does it answer your question,

Tessa ThomasRomero

on answers Yes, it. ATAXXX? the And one that then

Pascal Touchon

AJ?

AJ Joshi

Sure. the ask Maybe thanks question. for can I a clarification. And for

are -- of the disclosure that thinking between IA What the activity Is results of final and what what of you asking -- EMBOLD? disclosure You're EMBOLD. X-year

Tessa ThomasRomero

No.

it just Just in between June in like of to of interim the us the Is kind a and the yes. -- an differentiation July. kind disclosure

AJ Joshi

I really at do to before mentioned for you -- look everything. The thank that it when going No, think the we've it. analysis, we clarifying. interim Got we're

let's information We'll secondary a at to be, on MRIs, take at full the the biomarkers, every We'll have EDSS. profile, going isn't parameters, just the look be this of So safety looking looking be we EDSS. piece cetera. et at

we have and in make a really, data, good, to off want that to the based you of clean it those look take then analyze at So chance July. to all data, a decisions communicate

actually really back So crips and to totality that July. that information it's in to all a time then you response assess in us giving of provide

Pascal Touchon

a just weeks talking it's about. Ultimately, few we're

AJ Joshi

Yes.

Operator

Newman Our from with John comes question Canaccord. next

John Newman

results these wouldn't interim, the is, placebo XX expect investors? in So to the between the question involved the -- all separation you on I to the XX-month third meaningful be at then that ATAXXX the report study if And in the you perhaps interim? would Second you patients? disclose question clear months wait quarter? is, study see to of at you could us and also final was do the rates on patients and Or those potentially established was size data report until have

Pascal Touchon

if So AJ, want you thank needed. you, I'll in to John. and start, chime might

just integrity the believe, this that reporting in of sense be being over the improvement and to response jeopardize value be influence made behavior that data evaluating placebo a will and still study a EDSS is, on be So active clear, enrolling would percentage could a public the physicians in confirmed that of of the time. still of in study patients level or in the versus patients details the of terms study we

active that's placebo. confirmed EDSS So disclose not stage of in believe percentage to at we versus that why possible improvement the this it's

the the the do that's -- then your the of and results time be will in patients' communication data a the when to can disclosure. enrolled to can the months then, of patient do that will and couple end, last that's some And to X we July have as after available will a last question the visit Now clarify plan we something, when last we usual, clearly, visit QC. have at cleanup by before and and for going study be have ways, the second to way, year

communication be. So you whatever data, form can of the communicate on this that will

the that -- few enrolled? to to on last be the X X present able the of middle IA patients of So mean the at clear, been data has EMBOLD a we're will XX-month end which Is year communication of study, months that. going in not plus the after be year after patient that the

John Newman

Yes. That's clear.

Pascal Touchon

That soon that to planning we're planning IA. patient XX the to after -- enroll we're yes, sorry,

final important end time current So something of that's results. study mind to also the for target the of the in enrollment in of the and goal keep communication the

Operator

question Company. Frahm Our Marc and comes next Cowen with from

Marc Frahm

file on terms and full confirmation commercially progress on review the the proposing getting paths have the process in everything to of one of on U.S.? on review EMA XX, of I just made maybe of to the that Or kind question plan filed you the to EMA? is used of those Congrats day comparability the FDA, and to the initially within go you day down comparability. you're the XXX with within that, on of think the kind the My established for -- kind

Pascal Touchon

the cannot -- I I'll maybe then. understand you file the I -- XXX your you well EMA question. the mean MAA, day we back Once file process. additional to come data

is the for XXX the data initial filed questions you assessment critical based on day report of So and approval. list really

on we're, this also the basis which the the has commercial process that based data, comparability, have data support all this versions, set committee, co-reporter studies same and the So presenting time. we had the for that at comparability the versus the process that's course, of done EMA, on data version of clinical data that CHMP okay? the the we confirmed basically that reporter, that's at initial So

sent we FDA had Type the for in that November. meeting also that February. remember You B We we had filed in

you this of that set -- of point at put the data same EMA evaluated the remember, What that they've but any So the to together. we've data additional given we And data not view. stage, the has type had from the said that been CMC good by data. of or very the of strong is clear, very this comparability. very confirmed data And what confirm we data, always That EMA part we these believe file. review that's

Marc Frahm

to meet plan right, proposals that the least, simply to front lots one commercial of criteria restrict Pascal, trial. commercialize of follow-up, to of with -- Europe range in the were the you my Or think EMA? down Have the I was path the ones full to in commercially still with made? you release to the just the used you clinical that range put is that you're to product of commercial understanding, that going FDA, guess intending of of at gone use actually one that are the I in the lots

Pascal Touchon

Yes.

the basis commercial With because that on we we've basis established of range the -- specification. will of that's that the be full lots comparability, that since

Marc Frahm

some Okay. could in other the before run some how interim, what as that as in then And that well. not and Great. kind impact Atara maybe maybe of you've steps, but of have going into you next you partner might on through there for Phase versus potentially this in Phase be -- paths? the options laid coming think you the willing the just some going about Can out to is of within kind the some place and just needing pursue to terms terms, of down go down general yourself of II to indications III, you that of bring those potentially resizing,

Pascal Touchon

compared other want that IA III start the in. this allow as have are of safety starting that that Phase allow placebo into the active confirmation, III with potentially are will additional key move database. optimize especially Phase to X will and, of Phase II? why that we Phase That versus Yes. studies. into It's will us of the I, the to One difference chime have because go preparing Maybe And the and to milestone the I if AJ, hope, a you allow of in indications. data and placebo, will to then of allow number is, aspects. a we type to new here There us have us enough considering between patients. And to then, us course, design additional to

As X of part in III the And III one in studies potentially Phase SPMS, alignment you Fast we've doing study: as FDA discussed Phase nonactive on was some there the remember, PPMS. Track with designation may one of process. nonactive already design

preparing will data and fine-tune that start and with So to having III. the IA to the discuss from further us to design the Phase FDA allow the

about steps before when does that But on partnering. stop I'll will question your about we answer -- there talking that what exactly type So [linked] of part and take? with

Marc Frahm

Yes. That's very helpful.

Pascal Touchon

to AJ, II aspect, is operational So requires the into financial something and III, that? add into capability. moving on to Phase anything that other Phase moving definition, partnering by

on. whether is made, We're it's want manufacturing side, in bioreactors we prepare. manufacturing terms So after that so already planning, there the on looking some the imagine, we're start we stirred-tank we you the all the that we'll version planning product preparation. is can on making that. to that which have work -- immediately the have not is as and process mean can this new suddenly inventory, certainly to on step IA, of do for to use already it's I And the being at different already sites

to the creation for and of start is value is accelerate will idea even can So product. activities that partnering so before to there things negotiated can the we partnering and do expand lot executed. And of a we able accelerate then expand and the the be

Marc Frahm

then helpful. just very That's last maybe the is on Phase II. piece Okay. the And additional potential

kind want IIs? of the Phase III use Phase and running do -- before So and that comparability and therefore for we'll you do existing Or process production you any that up would more

Pascal Touchon

have we not are inventory the with existing existing can they because sorry, the have start – the process, They existing use Phase can III II. -- are studies inventory process of studies. pivotal Phase we of we No, so we sorry,

that any avoid one on to particular So commercialized, it's to to really have then a aim for debate be which same pivotal as is will our the then the product the that is comparability. allow

Operator

Burnett Our Stifel. next with question comes from Ben

Neil Carnahan

just On you believe This was conveyed is the Ben. you us Neil ATAXXXX, Could not to viewpoint the here? due you XXXX. cause on of help Carnahan your patient death understand that for guys

Pascal Touchon

Jakob?

Jakob Dupont

be I'd to happy do Yes. that.

Neil, for question. the So thanks

detailed And put as proceeding and study And in with. there very a Memorial studies event here So fact, agreed patient this the this year, we February that with number voluntarily Sloan FDA this still FDA additional Kettering which then and unfortunate pause, the Kettering serious the been the of the investigators of notified on forward autopsy of are, have Memorial ongoing. demise. adverse they in and Sloan

So there is additional data coming in.

So information analyses and this an the additional data with by event the information T on to currently comment of once XXXX, so Kettering, Sloan CAR case analyses have review FDA. autologous believe at shared we under is will unlikely and regarding it's And in that's caused review that been then further by be these against that additional mesothelin. are able we those this additional and forth, the

Operator

Our with comes ISI. next question Jonathan Miller from Evercore

Jonathan Miller

I I'll one point, an little last would if on of in for the water trials to that would looking ton What's willingness talking feel like? about potential study, upsize U.S. And at. to is guess. the that month I'm you're in a there? study? that In ATAXXX. like you I down you're needs for just circumstances on since puts the requiring to get I ago what powering on sort clarity -- additional of secondly, ATAXXX. guys? did. the haven't that a sense their maybe a while the this process not trying about before Suppose increase sense little get to hits foot guess for an look improvement tab-cel to would forward run MS make Under from need like the still size Day additional gotten move that bit looking It that that, regulatory or And At we what your IA for? we to this bounds to a the agency bar started And then change what were treading you what stats talking feels scenario, that you sneak the maybe are you the

Pascal Touchon

AJ, Jon. take do you, to Thank first and one you then want the Jakob?

AJ Joshi

Sure. question. for the the commented Thanks study. we've And haven't on statistical the specifically we used bounds for

information, should historically talking point commented And we're of at information looked you the EDSS that disease. had one -- expect reminder have what for from the that time We exactly one study to improvement MedDay when talked patients. the at almost look X% inform on a about, used study just those on placebo specifically and in nonactive as there's of nonactive for XX-month X% the about had the we types population approach. study study our types we've MedDay And same we've that

informs a put publications and think information I at where showed that of out is piece we that we that ACTRIMS population. in second recent Now AAN, that PPMS the full

didn't nonactive set X%. from we data the for was breakdown nonactive and was So X.X% PPMS, have particular a outcomes and multiple consortium. in But active assessment SPMS, for sclerosis that it it of

in in placebo talked what improvement, So pretty cohorts certainly, the And ATAXXX what a I expect should again, months, high-dose these ATAXXX, sense from expect got for study. should we've we've saw for at from from populations. XX the good we we about improvement Phase then on we EDSS XX% the

we've time that's used information at probably generally statistical again, IA on the have the there. specific that that the we to So numbers inform design, and not of would comment but the not

Pascal Touchon

information assumptions, this on aligned not soon patient, are IA. second therefore, if statistical question? AT. number I And are we also what should based is AT have that maintain should the -- we'll could all and which increase Jakob, patient if of -- we've the the the we used, we our after with add But

Jakob Dupont

Absolutely. Yes.

of pivotal speak was to you about, we So about late Jonathan, as point, the and B were more the little have Type And the material. about the that the situation final product. FDA comparability versions conduct agency FDA the confirmed we recommended based you that between received with just align tab-cel a CMC We study here that to have meeting on that the between at FDA, the we intended new bit discussion commercial the know, at the that Subsequently, February. the in time, the a and able, not as asking with minutes did manufacturing commercial the from comparability. tab-cel on and study discussion were

heard required. not that a study. have on filing FDA. we the in have you've CMC several already today, call do to the following Type the BLA require dialogue of And that not with we potential a And feel that, made enable does B the So proposals meeting, remained as we new is active clinical

the use version And we some meet we that have of of the specifications clinical-use would lots. for proposed lots range commercial specifics include that of process what only

So that's aspect. the first

in commercial product clinic. the Secondly, we already would having by data generated use

material. of the So we being with patients filed well And FDA treated for clinical actively did call patients. and post-marketing treated. are our to is we amendment, that commercial And the agreements we describe last appropriate appease agency with third component feel these from patients proposal of monitoring already that the are have proceed as can data willing it we IND with by we providing that the

believe to lethal state date; an proposals options, disease generated disease tab-cel's that product long clinical appropriate. an reflect with we trial BTD commercial an not these who of again, conduct So we status product is do believe where, additional and short, therapeutic these to important clinical really that with have of this would story urgent ultra-rare the we've patients medical the and no a need this be also, data address really

and be update next So the importantly, able pathways to forward we the few in the months. FDA is potential currently, reviewing on an proposals expect to BLA provide

Pascal Touchon

And if Type February. about mean, you think the I was late meeting B Jon, it,

We are May. early

So a and few months That's what, weeks. it. X

So been had we've discussion. been and we've had we we've -- -- active,

Type also. We between time like long been have very that and a have support B particular It's now. there not

Jonathan Miller

indication-agnostic enough. that foot Okay. this to does in this guess, Fair the on already have maybe really Does being want for that, if on I do or tab-cel? for product depend their impact an the doesn't another don't approved resolved indication, wanting approval potential puts indications you and PTLD? really trial on impasse beyond FDA other initial get the down

Pascal Touchon

in, study, designed multi-cohort might label and the to on Jakob, study. want chime is expansion as that is study you The a

to -- the some depending the available. be stage year course, the at will cohorts enrollment but be start of and these of and of available will be cohort However, speed then next available there on data following that, data

the to then today first able proposal. study be to indication and PTLD again, particular BLA indication to aim III is our without second-line Phase that Now with in for pathway the doing another clarify our with move forward

So label coming scenario, a data in and the BLA having of multi-cohort we're approval. hopefully that study potential after expansion type filing still for

Jakob Dupont

that is one and also in currently we're clinic for expanded our -- is study access And progress well. which the for and to we data. commercial Europe generating enrolling, obviously, for maybe compassionate use multi-cohort for ongoing, in the using The and so this I'll other be with And Europe, also make intend obviously as forth, and both label in study material studies comment. expanding

and mechanisms I that believe a are we being can that data of on do think we other solve impasse. there tab-cel, there's whereby FDA generated so this lot And

Operator

Our Sachs. next question comes Goldman from Salveen Richter with

Matt Sykes

what And I in This demonstrate what XXXX? to be I you is will Matt pause just the included presented? would tab-cel multi-cohort And are data will what on enrollment these read Salveen. for hoping separately, populations? confidence would for know, benefit wanted give in you affect in update XXXX? that additional to does see then the be And the in Phase

Pascal Touchon

you Thank your Matt. for question,

every we to few over clear and in will on last and be efficacy clinical of data each congresses these Just the and cohorts Jakob multi-cohort, on years. safety have develop that, presented the already different in

Jakob, very we've confident have from want in So the that what that elaborate that on do we ultimately what that? to replicates particular be is you seen study to makes should that past. able data us

Jakob Dupont

Yes.

I think that's right.

feel you've we these same of effective. disorder of that is the state are that have EBV-positive got we multi-cohort, which where therapeutic cohorts in a X tab-cel hypothesis PTLD are as drives lymphoproliferative in that setting, individual, in these an essence, meaning proof quite in the So then where included concept immunosuppressed the an all really

multi-cohorts. these Sloan of studies So seen pivotal or these an tumor-agnostic each we Pascal there on data to And filed on well. are AID-LPD will now response to Kettering on have historical, X doing well. product filing this opportunity of be that in indications, order we've data referenced, really registration presented be example, XX% for But we're PID-LPD there in us as which have there and we generate indications, as intent data a indications. file as as may And the all for rates study works. the obviously these could individually allow indication the other the Atara to X the of the mentioned, And and XX% and

Pascal Touchon

XXXX? And maybe in the question

Jakob Dupont

Absolutely. Yes.

So I think about the a good mesothelin autologous it's question XXXX program.

Memorial at to study, who this this a partners our medical second into half in the conducting the with Sloan have Kettering meeting do working put here year. data of this So intent are we

well. data, presented and unlike not we biomarker IO some certainly the data So presentation early and ESMO last safety efficacy as where data data year, PK

similar would present seek types data. of to think I we

be congress patients enrollment, delayed of been seeking cohort who which that the SAE to patient of Now has re-initiation enrollment there's that the event, occur, previously described believe was which to on had that But and we obviously X on We this study. depending should we be on this first able we'll the certainly, medical we're the hold, voluntary present dosed. data. patient the

ESMO So reference could then Cohort be to X that to we're able why certainly, And data the will compared pending to costimulatory then say, compelling persistence think XXX the we provide at in the look you enrollment, that data, and past data early updated platform re-initiation at tell, which with study showed the T these as study. be I XX in we maybe programs presented case. we'll our just in solid can IO quite we quite out of PK And domain that good is of that T now cells CAR tumors. at CAR with think is other weeks

Operator

comes Our Citigroup. from next Nochomovitz question with Yigal

Yigal Nochomovitz

hear you Can me?

Pascal Touchon

Yes, Yigal.

Yigal Nochomovitz

to is, at IA. there -- My be a around question Okay. still of bit going a confused to the little confusion little what's seems happen

from for rank those could happen delineate very likely. are So perhaps would scenarios what at most to if the possible could order just helpful everyone what clearly least interim scenarios for the it be you and

Pascal Touchon

Thank you, for Yigal, question. your

the the start want are the if IA the end in. that maybe data a power. these go trend with to of study And is therefore, chime scenario, of that enrolling So at that our scenario of kind XX, planning period patient to then patients. towards statistical year conditional basically AJ, base-case patients few time maybe stop now, follow you target we for then a The we the terms process, patient see we and additional are and, right enrolled the aligned But in I'll and in are patients to we later. additional we assumption and evaluate the or

scenario base-case the our that's that's because So plan.

sample for is we'll many sample results final increase when to increase can a that the we size. we study decide do study to end likelihood statistical the case, And in by when expect that for and have of therefore, significance the that that of the rationale will particular the increase. in and communicate to to there size. how we enrollment, expect in increasing where we need do we Now increase scenario the need And

not so planned with for us, is the go so in just that's and we So line forward that scenario. results far. what we we scenario again, far. what But because scenario it's hope see will Best-case we still been base-case a we've move mentioning we've other had seen that

likely you're scenarios about Now if most the order. that's rank thinking

might AJ believe there IA. that, futility possibility it's the is of also a analysis detail that Now don't of shows but it's that that study to always part very we have there. We any likely, futility that and of type want

that slightly scenario, we study, to And a we've one XX scenario; we that and So as there's Does the follow whether of comment possibly number that, for But pivotal been Phase scene that's of It's AJ, approval. kind year, sense, scenario. scenario the move at you patient in conditional to We have II it or like to And case various approval. can towards a the That's in scenario, that past, the where at course, study improve Base-case significantly patient, the bit the the ability is have why. study unlikely to the a forward. then, sample the the detail. significance enrol type to fine. we'll further, last believe that to Yigal? likelihood for just then patient X move file unlikely set scene. wanted well. discussing Possibility to it. the communicate also lead end increasing of most as of X data. situation scenario could a particular likely use extremely likelihood X a We low of that futility of but size is the very as we'll that if least fertility want, and increase statistical then for we make can of see We accelerated a that's reasons you kind

Yigal Nochomovitz

That no. very, very No, Yes. helpful. was

And just Okay. one then more.

commercial Regarding review they FDA? questions? your more of the EMA Or clinical EMA and required like EMA time to questions answers. did batches comparability of different also Was that about asking have types

Pascal Touchon

No.

question to detailed of I we answers have think that together this believe of And then. which the putting type question. a and is submission and question, a typical the they are we all lot all the data aspects lot of answers, of there we're and

On the that and put between in comparability their Critical they report, the assessment the EMA still data in preliminary Day believe a particular aspect comparability, of support of Report, they is commercial. clinical words the XXX that Assessment which

that stage. is at not the EMA debate this with a So

Operator

Our from is next with Tony question Capital. Butler ROTH

Tony Butler

Pascal, scenario. that just According guess I patients ATAXXX. you sites simple enrolling are XX increase could where to even for I have argue clinicaltrials.gov, assume think. upon let's the one there size. are base-case Well, you a been could -- question, or Based

the an XX go sites XX to anything to that additional time patients patient to So What's or sites, the if patient the the of to, IA make you for up communicated I'm all function? XX fact, anything? need this to just needs communicate were those clinical enroll question some other in either or up, if you at at because it do is, the such may, size making they even by

Pascal Touchon

you do one? want AJ, that question. your to take for you Thank

AJ Joshi

in. to got total work because it takes And target a course, procedures. on question. try for the very bring we're to on if going important, to saying, -- they've size, the that the want specific main these thing at because and but point screen doing the is through sites now they Yes, prescreen, of the get these then any lot all increase patients a of to you'd size. communicate get would here's think Thanks I they're going sample to a sample And detail now that to they're of outcomes that's IA, time here's the not detail then Sure. go okay,

So time that There's right? give to you lead there's time, always them. that want a lag

to in be limit as that would communication So be of we but want open additional the increase, about then. numbers communications possible as any

Operator

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

You may day now disconnect your lines, and have great a

Atara Biotherapeutics (ATRA) 6 May 222022 Q1 Earnings call transcript