ATRA - Earnings call transcript Q3 2020 | Atara Biotherapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Atara Biotherapeutics Q3 2020 Financial Results Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Eric Hyllengren, VP of Investor Relations and Finance at Atara Biotherapeutics. Thank you. sir. ahead, go Please

Eric Hyllengren

Investor our Good conference and members call. team upcoming update Atara operator. and operational third review also from to quarter executive our on an provide XXXX key On available an results will results Media press progress. and & afternoon, you, announcing milestones This and welcome progress everyone today, in updated third our press a objectives. issued Atara’s Earlier and the investor operational are presentation quarter financial Thank today's the and release atarabio.com. at we release call, XXXX section financial

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

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

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

Pascal Touchon

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

in in our sclerosis quarter and make emerging ATAXXX excellent third T priorities, advancing areas CAR our tab-cel, of delivering continue to and the of we free of portfolio. During multiple on focus, strategic XXXX, progress

T-cell the on year with deliver despite so immunotherapy to each mission Atara to to for track interim external like data. I new independent XXX previously the study worked transformative These safety and the staff And achieving progressing who objective would radiopathic thank tab-cel XX% safety in rate while quarter, completed third data strong, the ALLELE bring ALLELE a significantly, tab-cel response consistent pandemic. set or we study have serious to to analysis signals. objective with the diseases. much expectations COVID-XX We date, are Very meeting to an published oncologic consistent on on finish previously very milestone hard is also is with response pivotal assess investigator the by no profile in review. with published rate patients

interim for rolling the preparing Following productive Notably, submission by can finalize for initiate six and potential in that and we for EBV submission these tab-cel authority, very interactions encouraging and regulatory to particularly regulatory were initiate with gain clarity We launch. positive that can pleased and we pivotal on the with approval regulatory PTLD tab-cel are avoiding submissions, complete analysis data package then study now submission of QX patients response. the follow EBV filing up currently least XXXX. in tab-cel the the all the XXXX. BLA positive at to with of expect for of plan BLA We elite on months end And PTLD durability we with we BLA FDA. of to

the and to We XXXX. treatment has survival patients patients for is of more lots positive you commercial commercial proposition value HCT approved manufacturing PTLD, PTLD transform for compelling The that aggressive, Indeed, three authorization also the two an believe with tab-cel no needed deadly are of tab-cel, scaled and healthcare of With a process prior the EBV with been are with therapy. we're positive support an we application median Jakob XX on give along completion over cancer validation will and events. potential survival of PTLD up system. inventory the investing launch. in offers in SOT have with often or and a in details PTLD, for updates near marketing referred shown EU only the first as we be positive therapy to to the studies of is half years building treatments adverse for relapsing in the to that moment. EBV submit rates Meanwhile, two XX% months. the regulatory one fewer about related to second at are responders We patients track EBV

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number In labor study related the specifically in program, such clinical positive in new a would potential tab-cel of goal QX beyond in data expanding X additional tab-cel at EBV for and cancers. to PTLD, terms patients, closely multi-cohort we associated highlight the given ATAXXX. immunodeficiency tab-cel the lymphoproliferative with the initiated now potential Phase expansion I need presented ESMO. PTLD, I immunocompromised sclerosis significant multiple and XXXX medical like label unmet of for transition would of our to for tab-cel, like driven to potential disease

patients, for are achieved so therapy. to existing for with about excited bringing potential very become clinical benefit a We transformative far the ATAXXX MS therapy not

that proportion maintained with the suspended at achieve font, ACTRIMS-ECTRIMS a points will XXXX, September time Meeting anytime improvement higher and increasing positive therapy the in patient it FDI ATAXXX short show in at all As NS with at future of data patient of dose. Joint reminder, with held presented AGI

months. the label extension to will over next an continue We present from additional data XX open periodically

at be With to XXXX. data of as European the Meeting held Annual search XXth November additional Charcot next XX Foundation days the three of

we of XXXX. into needs allogeneic the priorities. across making patient At efficacy cash, believe strongly populations, Atara innovative platform caregivers, we like increasing new DNR to over fund ATAXXX of MS. to to this sincere differentiates of T. which With double-blind and we at confirming are international PD-X CAR are of impact trial, third million development. these are patients by CAR possible, are staff These clinical in our progressing in profiles as cash our programs T. we investment cash research, are that on the support to differentiated given leverage to particular, short-term ability regard allocytotoxicity the Switching transformative quarter therapeutics Atara. and strategic the progress programs. believe T-cell rapidly placebo-controlled exciting our us the runway, developing a at with XXXX process CAR have and are investment, transformative the as has response, advancing conclude and to and improvements improve manufacturing our peers programs. and T efficacy, with at which and Additionally, randomized we to we now from believe In we the safety of enrollment We position three EBV potentially on that and creating to scale, of sufficient in XXX.X meeting in produce our allogeneic and and portfolio moment limitations a and addressing T-cell collaborators these with them Jakob XXX happily durability I'd persistence ended equivalents as QX EBV based deliver other expressing new plant detail of operation and platform ability in to patients, exciting value and aims large the technologies competitive to we like shelves thanks

delivering Jakob. committed all will on are the I call and over corporate shareholder now We to our value. goals to turn creating Jakob.

Jakob Dupont

ORR PTLD That reached achieved with following review response independent had with designation HCT interim new SOT. Thank is significant initial breakthrough is safety conducted for a in the interim in the ALLELE This progress rate Phase and which follow-up previous PTLD, States, in with This we've patients in X obtained months you, quarter profile the XX% EBV+ the signals. Pascal prime designation with with we published was we third at objective we've consistent IA after previous analysis data oncologic investigator Pascal quarter, made in in as The very and safety advancing The response tab-cel tab-cel regulatory United Europe, assessed noted, in radiographic data. regulatory authorities and in either six productive no for and gain with overall the had consistent least both clarity interactions or response. analysis package also conducted regions. ALLELE study tab-cel's on published rate EBV+

that meeting, recent includes experiences package a clinical presented comprehensive BLA ALLELE Memorial After and is analysis, key extensive This aspects now patient Sloan for data the Phase in package alignment acceptable single shared to with study We from including of discussions the PTLD number FDA. clarity real the a the to data world X points support we and During data and one, the package regulatory BLA. of the Atara productive regulatory safety EBV+ the use the Kettering Phase X for on and tab-cel we studies XXX a interim efficacy agency. have with tab-cel clinical submission EAP FDA, data. with and X Phase

clinical Additionally, remain submission the for on XXXX, needed least after at status FDA amongst world will end of submission to months. consider, in in our in we data current least completed to the finally, and patients. six FDA the BLA follow-up a of response patients this the XXXX. and in and manufacturing approach BLA CMC we a studies, FDA, And each responders, part with meeting also with the We our module. as the finalize track case already In had separate pivotal productive to study study tab‐cel of study submission initiate will a for QX supportive have BLA PTLD enrolled the real for and engage patients this regarding BLA having in number a of submission. duration the of to with EBV+ the discussion the following. six BLA typing expect months experience by for BLA the of rolling we followed the And recent data the the with continue MSK enrolled as rolling XXX The at

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rate XX.X% in in and the Specifically, previous XX.X% PID-LPD had groups. patients failed, AID-LPD, objective was where treatment in response

chemotherapy to tolerate the six LPDs, two within patients patient populations cohorts of will risk We including treated and AID-LPD of of cohorts need especially, deficiencies, frontline this LPDs have immune evaluate and therapy patients genetic Tab-cel because respond to on multi-cohort PID-LPD. for treatment-naive have study for coming In patients need, also underlying responses with these favorable coverage saw immunodeficiency several life no threatening with immunodeficiency as have arising diseases. well tolerated AID-LPD addressing effective need PID-LPD due options, study to acquired is patients sharing infection. EBV+ chemotherapy with with often and are as significant or The Patients previously who well look previously was conference and PTLD substantial poor We a generally profile unmet cannot consistent forward there there associated Those calls. including initial fail primary in tab-cel. to PID-LPD clinical relapse a out studies, in these an and prognosis. chemotherapy or standard complete doses two approve both more free addressing safety EBV+ to with unmet

ATAXXX our sclerosis. exciting multiple program for now to Turning

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data on present will XX months. additional patients We over periodically next OLE numbers larger of the

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the all soon, double-blind With to the XXXXaAnd European investment in Charcot XXXX. first trial, Looking the clinical to results control ATAXXX XXth cohorts medical and e-poster and randomized ahead, encouraging need June the to we significant MS, XXth unmet four additional with in to-date very are enrollment will November present ATAXXX progressing from held OLE is an Foundation increasing Meeting patient enroll we we of study to data in Annual of the an giving now respect XXth placebo the be well, progressive and the studies program.

generate the RCT of to of primary the desired. clinical meaningful the expanding endpoints value. of are data X XX improvements. to create the allows to for We cohort least endpoint size opportunity study if at and The Maintaining deliver disability biological the changing to to addition patients dose more design the

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Pascal As on we to significant progress continue fronts. make all mentioned,

application T Sloan Kettering called track at and collaborators study our quarter, in immunotherapy has to our from for the Phase the CAR have initiated last first clinical patient been to ATAXXXX. the targeted Memorial next-generation submitted FDA study The MSK, are mesothelin noted they autologous on we the months. enroll few As next X in at an IND

when technologies DNR IND cell and mesothelin with tumor first utilizes generation program In PD-X vivo compared improvements DNR CDXX, addition, and multiple progress and functional exhaustion, allogeneic which CDXX construct less maintained mesothelin persistence, XXX EBV Zeta-based T the through is XXX CAR. which efficacy, through was with enabling associated This differentiated and ATAXXXX, leveraging PD-X cell killing in serial re-challenges we making T platform. our called cell studies CAR are with our

promising XXXX allocytotoxicity demonstrate without Annual Annual showed this of of that survival -- are SITC persistence approach the cells cancers. benefit data and XXth for in anti-tumor be in potent treatment or presented Anniversary November EBV the significant the CAR vitro and mesothelin of and preclinical data will year. for a Immunotherapy engineered mesothelin XX both allogeneic activity, Cancer vivo, These between XX evidence that T at New of Society suggesting Meeting positive

Exposition CDXX of next-generation with potent collaborative FDA the successful a conducted allogeneic ATAXXXX, to of the ATAXXXX off-the-shelf We T Annual Annual ASH being and virtually was These on of CAR TCR in and for receive Society at data presentation preclinical December XXnd package without enabling held studies from filing. Meeting this demonstrate are X a or need XXX IND meeting the X accepted of October through and filed a year. cells at progressing year ATAXXXX to persistence, utilizing detailing will technology XXXX. moving in to the efficient this evidence vivo pre-clinical tumor And editing. in vivo. both IND first in feedback vitro of with of be This polyfunctional for ready ATAXXXX. CDXX-expressing presented in the phenotype Now the pre-IND and targeting be guide and abstract without allocytotoxicity expected abstract Hematology data

extend collaborators, to like to our I'd Finally, patients sincere caregivers. my staff, thanking

We accomplished I continued in to on to future. now our the operator QA back providing look in of forward call, much call updates I'll to the operator? and this progress begin the you, to portion thanks quarter have the near the turn

Operator

[Operator the Canaccord. Newman first line comes of Instructions] question Our John from from

is line Your open.

John Newman

about any relapse wonder cell in attempts, the comment could think receiving transplant. studies what as data I Also quickly organ could is congrats here. but few, response after Good I Curious very very know there? to so expecting guys. were, if you're patients I patients you stem very experienced Thank if good. after receiving if tap earlier solid interim there curious, cell tap transplant you. evening this seeing patients that this after and Weren't – the the Hi, on cell an breakout talk interesting wasn't at versus between all you

Pascal Touchon

one questions. any on to your questions, for you take SOT, these there? differences HCT John versus do the Jacob, you, two want Thank

Jakob Dupont

Yes, absolutely.

the John. for you thank question, So

We both therapy HCT ALLELE have received with have enrolled and the and characteristics. SOT as in per patients previously, study protocol prior the they

so XXX of HCT both of data the access, and of SOT patients, historical Kettering the And HCT number study or as SOT both and well thus that both package far. exact have the patients reflected Sloan with from mentioned, ALLELE the data We And are shared they studies, SPU. SOT as studies I Memorial or the these they the not prior includes agency with the the the patients from expanded the the HCT in why we the we indeed data have are we study, disclosed much patients. we itself, enrolled comprehensive think in breakdown well as not disease the study, is but linked specific the previews believe as BLA, FDA differences differences disease in for that presented, really up. in Considering more were And filing. that patients, will That's the I differences add aiming data were but the together same. that in I response because some rates that

FDA in floor the bring require Of course, can has fit the the we goal to each of sufficient benefit as the as will also, agreed And that to combined to be data that demonstrating the done. in. these population, type well That's in FDA.

Pascal Touchon

Now Jakob? response to type the want tap to address any that after cell. relapse Do questions to related to second of you

Jakob Dupont

Certainly.

see around a ALLELE we cell, response was we see for relapse, on course survival making two actually of be investigator So our where either again as That's response in where by patients experience historical SOT. as rate following tab to the of XX%, the of We long-term we to in experience. any the can order that of historical HCT XX% are, the we're of once two study we durability over and historical profound, of turn of the alive response data, we on years. at duration reference with Pascal following with assessment And patients patients follow-up years XX% well. quite at concerns for or see to see

therapy the patients, from gain are the We good But of continue rate durability patients tab-cel. EBV very HCT and after And certainly who two follow the to response with mentioned we remote Pascal, this on and the PTLD going SOT of of outcome point on patients is response about to by sick positive, months. for these was order three reference. to that these survival And previous receiving study. feel are the

the our we we see we that historical that is fact in numbers think promising. see the very So data,

John Newman

Thank you. Great.

Operator

question from next Thank line you. And with Syed our the of Salim comes Mizuho.

is line Your open.

Salim Syed

the color early on be I month Thank month timeline the be, wonders all Great. up data that simple that if going changing duration just who here? you? kind much, the exactly with the of the on the that you're like to Was progress. we'll the for following current this number? disclosing of something now past that me -- what it And was XX always it? Or data only was and the similarly, response be question it's is is specific primary on patients program, kind just you. congrats Charcot, data Thanks just we'll for ATAXXX six are getting okay, so to concert the guys. recently that we're at that and mark? the the I Or again, then, Appreciate be can, that was yes, the lastly Just the Second fine. the tab-cel. getting? is FDA duration on, that something at communicated no, the to improvement, now was that appropriate Two going disability months of And Or something was there, the on FDA? center six endpoint done that a looked they in in was of guess follow-up

Pascal Touchon

then address chime thank question, start address to question. ATAXXX can Joe Well, the in I'll will then and Jakob you. the first

the had we months the from really why that that's rate the in adds that duration BLA, already response is response presenting And clearly, is six FDA six in the surprising, follow-up the by past. but the response. patients XX%, data of the not objective for is them discussed we're with being that months So something asked here

XX%. a that's so Okay,

have know then what to that be we fine both and are asking meeting FDA to have six with the be October, we patient the also discuss type is in the followed them flowing and when response. month for is, Now, been now

surprise not of duration from So the Jakob, surprise, that? any to to about FDA. is add anything there the required is not follow-up that

Jakob Dupont

Yeah, you're Pascal. right, I think absolutely

I a six common the of months drug, very you when for duration response rate think a response agency it's desired. data have from that request is

Pascal feedback. have it statistical track this this analysis into for much illegal our regard. on we're we We've mentioned, as built plans study. the in And so And very

Salim Syed

you. Thank

Jakob Dupont

Joe, do address to you changing ATAXXX there? want on the importance question the and primary

Joe Newell

Sure.

With And Salim. endpoint, a thanks bit do we changed them the have we the this the of from submitted the to primary But change. actually the as regard we've endpoint per primary communication with So view we've think, to all that FDA. in part commented expect, do on the And already Jakob's little the of protocol. expect endpoint as that a protocol I made endpoint earlier, changes change, terms protocol. their in making we response made of we've year. And

Pascal Touchon

-- then Charcot? was there And

Jakob Dupont

that some all going thing into on that basically, you're will open the patients label last time. have course, yeah, we additional of as you see patients the to data, the presented, as just extension well since their the Sure. show -- the of And overlay for is previously, update that enrolled that

increase the number on So of in there'll report. be patients which a significant we

Salim Syed

so Yes. Super much. helpful. Thanks

Operator

ISI. line Miller you. question Thank comes And with Jonathan next the of Evercore from our

open. is line Your

Jonathan Miller

you teased those that the remind Hi, planned timing and And the some question to on? would additional just indication kind integrations X, the that you possible how within beyond Do FDA guys. maybe think Phase multi briefly with those cohorts the to different therapy will that possibility assumed have the would cohort HCT you Thanks past, be it you that you returning PTLD? about then expect study. the to to of your do progress. Or you study Then all together? the up those tab-cel I require the datasets cohorts. the talk might you an indication, differentiate taking with have? to and given the and much in of us gene between the EBV to positive these could those report you plan focus prior SOT of congrats what be based in just on two on really And I'd earlier indications and so experience if for label in in like wrapped

Pascal Touchon

to will you you, want Thank Jon. some cohorts with address address AJ, medical first Jacob standing the on the next and might questions the then two.

Jonathan Miller

and there's From the are as sure. cohorts the on XXX directly Though AID-LPD perspective, leiomyosarcoma. cohorts just from So holding the timing The PTLD they well a up the EBV timing on ones with don't PID-LPD a compete as from perspective we've opened bit cohorts. we're theoretical the the – always positive off that a study, possibility.

So to the we but want other those XXX, on open. complete hold the off we're until are on cohorts

Pascal Touchon

want we come AID indication discuss questions from Yeah. we two related on will expect as we that be to EBV and And you I XXXX. the about and early want with the are all FDA indication Jacob, first how to more definition, that's cohorts think, the as or data address for EBV to cancers? do could come believe the PID with patients the by potential addressable which there,

Jakob Dupont

Absolutely.

Thanks, Jonathan So the question. for thanks.

multi of approval the in the the additional cancer, the this one that that believe a benefit eventual regulatory information if have you cohort the you. that positive provides power then the distinct populations, represents adding of there's EBV cohorts of recognize PTLD, in for tab-cel with distinct and So mounting that tab-cel cohorts on an stage. each so that, of filing, for each also opportunity we But study that a we that's

also therapy, particular agnostic a allogeneic we that to for can more done. with tumor target a data and cohorts specific can opportunity will your we that the a So unlike agnostic diagnostic the sufficient indication for namely has in upon with separately. EBV think will also the that the FCT test, FDA positivity. where last we for is cohort either to in in be said as I look And amounts the way question, we considered be combined the FDA, way, tumor each generate think for then, have or obesity certainly, by the ask T study, tumor with with benefits as The opportunity -- a agnostic filing. we this regulatory ALLELE share again, together that we're data, engage certainly status a so we of SOT a I going ripe as provides did for have was as label tumors, and earlier, combined population to label. This And individual in to BLA this there. And to look as not at indication. to cells that potential And show the EBV well the abnormality the filings, the agreed date

So continuing this with we'll an the label. meanwhile, appropriate it how Does communicate answer that regarding a potential to will And question? at have your be time. we'll be FDA population addressing discussion feedback patient

Jonathan Miller

guys. absolutely. lot Yeah, Thanks a

Operator

you. Thank

Our from next from question comes Ben Burnett Stifel.

Your open. line is

Ben Burnett

congrats add And you. data I'll Thank Great. well. as the to my

don't some or Just a see that is did safety on this of you you partially also, just given then neurotoxic can disease cell Did is I you graft just one And was certain terms formidable anything a or profile host this just there? terms seen see in you match that given CAR-T that, a have follow-up. in anything the that And versus product. studies? kind you've and if of product, of CRS then T first HLA surprising question one mind, you think on give in

Pascal Touchon

one? that you to do take Jakob, want Yeah.

Jakob Dupont

certainly. Yeah,

of Phase has single recall is use obviously also for which Memorial we're mortality. related month trial, expanded a pivotal quite any data product. there, thanks therapeutic, the So seen efficacy we've we about partial for profile, any that Sloan describing seen Phase But this X noted with the have with as very seen any therapeutic, experience Kettering and that this not This safety potency a patient the X actually neurotoxicity, that as the between And well but the our two we have not trial, experience. And spoken question. experience, access the today. Ben, see a match treatment HLA and lot just not we a actually good ALLELE CRS that comes clinical we have you that is, as

deliver have that very excellent safety quite a lot a safety can we we profile. really a think of we effects, off within shelf throughout treatment therapy And your mortality. this we recall an And experience. can to those So neurotoxicity acceptable safety either any or to where see this days. say we that, And CRS serious have the three profile, related large patients is question, don't I that

for So meaningful that is quite patients. we think this

Pascal Touchon

comprehensive at -- about therapy, have partially as the HLA our this well treated hundred if of sales on now the treated believe, terms Atara, very XXX, that database in we since ATAXXX a that altogether and partners, beginning. we patients I strong been with have our academic that we in matched about As -- HLA-matched think And you partially within there will patients, database several with -- therapy. of safety safety the there these in of total platform fact means our insist the that have very all T-cell terms

we once with be discussed a So confident good very about we the profile FDA BLA. feel initiate the to having

AJ Joshi

point, to any data just either. And one final We new signals pivotal OLE the of not underscore in see maybe cells. than safety did just

confidence. our increases also that So

Ben Burnett

it could super a III and in I Okay the ask if earlier helpful. fantastic. tab-cel one And manufacturing multicenter experience was study. just the about Phase with study, That's your supplying

any tab-cel So because were so I there I get timelines the number proper guess have there. average who of product didn't what an was HLA patients Thanks a for patients? to you guess, match? much. And delivering

Pascal Touchon

colors answer that few patient? to to want that Joe, Thank sale you terms days few But for delivering a of The within to is the experience you a in no. question. maybe, add in

Joe Newell

Pascal thanks and for the Thanks question. Dan

times And to have we to but even stayed have period dropped an to platform patients days our COVID, patients I quickly architecture of we've a is we our domestically easily performance also actually three during had -- get that testament shipments overall which honestly, recently. no within response quite think whatsoever have prior and and time. during seen better COVID and consistent delivery to to ability get delivery quite relatively tab-cel and Our a

quite So here support. perspective, by a validation our a chain sites Atara our the from that and clinical that delivery efforts supply made supply the consistent, compliment portion the chain to very and at for quite of we team

Ben Burnett

Understood.

Pascal, who get correctly, said product understood no match? you patients Okay, and were you there didn't improper I if of HLA because if

Pascal Touchon

all there to patients matching able enroll could them. the have to I think proper we deliver been with we that

plan lines of is of the the We offer of in As XX% patient stage this time at inventory over population. our you rebuilding to know, terms commercial cover total for tab-cel.

Ben Burnett

it? Got Appreciate much. Thanks it. Okay. so

Operator

you. Thank of Marc Frahm And with from our next question line comes Cowen. the

open. is line Your

Marc Frahm

X is since would Maybe have the limiting my Thanks turnaround also that firstly, the taken that the into BLA congrats to are -- this you BLA? rolling just on submission interim QX to you'll time in the February. the turnaround are quickly that is X the for in and complete questions how product the the It's August, follow was things there month can or rate -- follow need taking months evening. the what up you limiting imply other roughly that data to in step completing

Pascal Touchon

was in Yeah, I there, that X group rate. or of start our objective something patients Jakob there. patients we XX% you and rate QX, be certain IDA, we of response a of did want will response when had that with for response the that's for we chime might It couldn't the the months number which to in

discussion that response all by time Now, the been the follow for October, the of patients FDA basically patient in meeting at this the duration was have for the and had throughout well. the all up the of in we got that what as an FDA with

of submission. into why that's anything you to Jakob, from QX QX the this end up So then add? completion

Jakob Dupont

And just the underscore Yeah. I the want to of rigor process. also

and interim IORA, data. And oncologic rate independent response XX% assessment. so by the that the mentioned we was radiographic of So

authority an step So get only Atara, is that cases. is patient we additional really provide And but data independent from we there the to that takes histories this additional little images and also step not which assessment, then, analyzes this while. a and the where independent apart this

as in full look BLA the So clinical we're then and following the together aspects it of the we do is module. our these here initiating data at the with the the CMC then other Meanwhile, the overall analysis the module independent together all data things. plan also of have span the the said filing we putting again, put the we're it, we BLA authority, cut as will we’ll in December, and we'll we'll then analyze -- other will put and and

that's and undertaking to really a one our advantages BLA of filing. we're complete the ensure and also we BTD of approach the take also be So status of can the that systematic is rolling the successful robust BLA, rolling because with going that

Marc Frahm

Great, a the in thanks. having And very your CMC helpful. comments, It's with the prepared then, you second meeting around mentioned issues. FDA

Given or now the agreement if things already submit like do FDA complete still to you to do the some is the in have be then, with And need discussion data on you for compatibility, there that hand you to assays have run. have full agreement, there? exactly are still tests what all there or need that

Pascal Touchon

and start might Jacob I’ll in there. Yeah, chime

Joe, clarity finalize the as these to we to Jacob, discuss to think FDA, well with, to in the from making Jacob good anything for as Joe we might of want start. add, same posting just and have batches, But, already finalize well, BTD with rolling are At got we to be progress to time, we’re are -- we’ll but stage. And them, the submission. there. good and part start slots need we’re if I CMC progress that chime to very discussing the part also the and our commercial in as module, we've model. CMC continue to that the making have we the testing able and you and of we

Jakob Dupon

Yeah.

Joe and an dialogue true. of number experts mean, -- at we is here been further. And this think can have Joe I that But a articulate this really Atara. that's and I is ongoing having and

around made and what in be on FDAs a the we've understanding the of progress I the to lot With BLA. of think CMC, needs

Joe, So we're more was, I good of feeling But the probably think that speak asks. Marc to the about progress. question that nature the specifically quite the you can assays

Joe Newell

assays Marc. You and and really validating in been a question product but the good collaboration been the Jacob here, and in to years, bet. potency ever for capsules Yes, Pascal, three developing Thanks the event. since how it’s demonstrate accordance I've we've a a and mechanism mentioned, with about works half FDA as very stated the

from that everything with support aware been have so perspective, They're And an done them. to connection of that. that we outstanding there's

And up Performance part a will be the with just big clearly finishing the a is activities you Qualification addition, we're final part, completed In all aspect. all that report as know, Process We've testing. submission. Three including the associated Module of that,

think confident very with position. the I of So testing right package strong us and approach from perspective, our the will very we good we're in our land front looks representation collaborative a FDA, in have that solid, and

Marc Frahm

Okay. Thank you much. very

Operator

with our And Citi. Yigal question you. the next comes Thank of from line Nochomovitz

Your open. line is

Samantha Semenkow

taking is my on Yigal. the This for I'll congrats the very on Hi. Samantha for questions. Thanks much add And data.

in to Just how you able the analysis? included interim were first, tell are patients many us

Pascal Touchon

Jakob?

Jakob Dupont

the of we currently patients clinical of at in basis in commenting patients that filing, will data BLA enrolled are the are mentioned discussions the number in that the as counting with on currently interim We, that we form FDA not are analysis. a sample So were the of size. but the and number stage, this we have not

Samantha Semenkow

haven't XX understand patients. continuing all presumably And because durability have Understood. to I you enrolled you're you're to not months those for going then Okay. six all enroll, data patients. of

are those you would the -- the in you including considering incremental for patients ORR BLA? analysis So this

Pascal Touchon

Jakob?

Jakob Dupont

the Yeah. Thanks question. for

BLA, well. response enrolled tab-cel of the ALLELE complete for patients filing yes, BLA expected number our patients the to opening of we is So in authorization we'll review enroll process sites will patients which fact think mentioned, and to to BLA as to And further through to but can get that the that I and we also we the durability required we the necessary patients for But us despite as number new the further that continue the well. of the subsequent the give have study. this payers of EAP, provide data demand as with additional receive discussions during support lead market continue enrolled

we as of to So for haven't EAP to BLA the we But the do enroll required to thing study number mentioned, provide rolled to on patients. the submission. for that the patients right think and patients is the continue

Pascal Touchon

to currently patients So finalize clinical the need but again, add enrolled need. BLA don't as module, also need submission and we’ve more the to patients the we offer we've there, been to just make decided to for be that to clear, for continue sure we enroll to a the follow-up to the enrollment in use we access the to can extend patient, database say just

Samantha Semenkow

ATAXXXX, X quarter. switching Okay. to enroll bit trial on Understood. to certain that patient And are you that expression you or tumor-type the then Can required this tumors study helpful. the just phase mesothelin. for mesothelin for phase be trial? specific cutoff give is all that's detail there That's targeting first And little going X entry? express a a more that Are will

Pascal Touchon

want Yes, comment entry? this And is an to on from you advanced do mesothelioma specific cutoff mesothelin Jakob, trial.

Jakob Dupont

Yeah. Absolutely.

lab this really tests pathology Kettering. Sloan mesothelin Memorial the So utilizing for at is

So immunohistochemistry this that's IHC an is utilized. test being

And so for that IHC metrics they're using lab standard path criteria. inclusion

Samantha Semenkow

wouldn't Is work me. reason that other that any And do this just to mesothelioma? to express one Okay. there mesothelioma targeted for expect to XXXX me tumors then specifically as be last you believe and or

Jakob Dupont

again. Jakob, is This Yeah.

would certainly of other potential have a believe ATAXXXX number the solid and do So in we that types. tumor ATAXXXX allogeneic

a we potent over can expressed cell other this think so a mesothelioma. provide patients. could cancer, therapy certainly type tumors, mesothelioma of of ovarian tumors, you non T rather, and on in those where for are number of is were CAR solid of mesothelin But initiating lung including pancreatic number – cancer, others And small benefit cancer,

to So of our me, wider cell products certainly populations both mesothelioma. intention explore simply these in is beyond

Samantha Semenkow

for Okay. the question. Thanks taking Great.

Jakob Dupont

Thank you.

Pascal Touchon

you. Thank

Operator

Phipps Thank question next Blair. you. [Operator Matt from comes William Instructions] Our with

Your lines open.

Matt Phipps

post-marketing that a the and just taking an line on intern Good the Congrats based Do maybe I one clearance FDA for added. saying there's have XX-Q interim, an afternoon. added guess on question filed, requirements Thanks in here. me.

interim that is based the So EMA? after maybe any or on analysis, on feedback from post-marketing this any FDA requirements

Pascal Touchon

terms No, some commitment. interim that, that, it's think we when they of some data situation for have ask then a just be Matt. and specific type I the submission you based have might on in not there, you based typical Thank that that of on its discussion on additional a

with EMA wanted So the there discussion that, specific took to that about no is clear make place sure either is or the it that, FDA. that

Matt Phipps

at guess, I look on that Thanks. know, follow been original don't delivery. that conducted being to believe data. MSK there's I good. That's XXX I academic version up of IV guess CAR. novel started look the any I also presentation guys Great. I are know, you CAR the out eventually plan if at update from XXX curious, Infusion an IV you to novel know delivery you with first- guess, I starting get the Intrapleural we'll as any but just IV in well? of

Pascal Touchon

as to pursued what's is program not intend make used mesothelioma for that to as you one MSK Atara think go being But stage. XXXX, is academic trail program, and they some we by maturing they the are In an when T. is administration first-gen as wants been know that the cases, both XXXX. of I beyond program, as some this to another to study CAR in well data continue happening is Atara is were and that has probably problem advance there the the which presentation whether entire not at peritoneal data

of natural the biology be their factor, with the is because also the goal an the but to only and XXXX, So we not in EBV course, we of persisting, teaching And second x IV. to by with IPO mesothelioma this and due of will compound. the one the for going to DNR, advanced cases, and study we benefit trafficking, that example, particular the with in mesothelioma, followed construct an then believe that start for both XXXX, code believe particular the terms PD-X T-cell, that in

Matt Phipps

Okay. Thanks, Pascal.

Operator

from question next with our Rama And JPMorgan. you. Anup Thank comes

Your open. is line

Tessa Romero

is This Tess in for guys. Hi, the Anupam. call

from MS side of the on Just one things. us

the meeting those You Thanks we are for so that describe us with of ATAXXX. by year regulators be planning scenarios are maybe the should can much. guess, you regulatory range end I discussions? for with this what considering of

Pascal Touchon

do Thank want you take one. you. that to AJ,

AJ Joshi

are we're feedback that the endpoints, and feedback our A study. endpoints extension the to Thank change We've scenarios label Part you're already on for from next you like seeing then with potential them program? time speculate I'm of months' with are talked of at. considering. you things and we couple do as it expedited get about hard -- assuming it's Phase fast-track, feedback for waiting really about things time of prequalify the we all month. talking program the the we've we points the on the XX what several on of changing key past of data versus were Sure. then this things that arm think really open based pathways, the and the for also we'll like question. And And those get feel on the And then we'll in are in XX Xa, discussing the as those the we're points months them. breakthrough, some because when that the different on about the talked well steps

one from we every those So, to a of expect receive feedback, the feedback specific pathways on FDA.

Pascal Touchon

Does it answer your question?

Tessa Romero

question. Yes, for great. Great. that's much Thanks so our taking

Pascal Touchon

Thank you.

Operator

And next you. Maury the from Raycroft Thank Jefferies. our of from comes line question

Your line is open.

Maury Raycroft

thanks the Hi, taking for everyone. and my questions. progress Congrats on

sites is plan say many first how open additional if the So, opening And how just currently? one can overtime? the on many wondering sites so you on you are OLE program,

Pascal Touchon

the Thank to you Maury. answer do you, question? AJ, want

AJ Joshi

be to just to I have correctly. just -- your so make Sorry, sure question

I correctly. You're looking asking how we're didn't me catch open? about many to sites more that

Maury Raycroft

and open how you opening? then many more on are many How plan

AJ Joshi

-- of before have activation up seeing the point, we're activity demand an open site probably going believe that sites we Europe I continuing to expanded because be will there perspective. it. site you that the main and areas access Europe, in we're around mid-XXs to we've Got something mentioned at this the in have be we from opened to activity

we're study want And So, alluded always than access environment. to there. kind an environment make best that we of through able do the to, a as extended it's meet patients needs to to of the sure Pascal

So, increases. up much possible. that's keep the plenty any pathway of and just sites to patients running see for want we But got access of open that where you'll we've keep as majority open probably other you and as know,

Pascal Touchon

recently We just in in are that adding being of And need is open. open the patient in for process addressing the the don't recent deals only that gaining patient the experience But in not also just we as to important Europe needs are some Europe. we are of increase today site AJ enrolled aspects first sites. specific number many has that said, some terms significantly up there competition of with first the and accused we you time, OLE the very to are new there setting the in and that and study be clear, showed

So in Europe. experience anticipation submission base that's you -- great to and launch create that of confirmed of which have future in with

Maury Raycroft

you it. the study, That's and the you on? phase those phase Got read and X And and have studies, in versus then based what haplotypes EAP in talk to if the switch often about response learned did X PTLD time can how helpful. the you for

Pascal Touchon

Jakob, do you one. want to take that

Jakob Dupont

can contribute some absolutely information Yeah, AJ, and also potentially.

survival of on the very to patients either after three order beginning, prior these So, SOT mentioned HCT who've short as therapy, we or in the had two months. have a PTLD

So in the context of rapid need really response. that, a you

X very, very these So if really see you We Memorial look so And have the data weeks. a phase a survival. order because that's of at forth. academic Sloan occurs patients on important in Kettering the that do really short response and

but for I aspects aspect We're comment further So response today XX% articulate IORA to historical I those can't on that safety anything rather the rate by the can disclosing AJ? data, IORAs, ALLELE of the profile, study. the contribute, and only

AJ Joshi

not day. a on Jakob’s specifics at to going we're to I rapidly the end This No, point, is the give just that underscore, think disease. of progressing

order in can to therapy have have Intuit response. be successful, to relatively that, you So going a to for rapid you're

Maury Raycroft

of switch particular And in term which AJ? of therapy comment, any type

AJ Joshi

think time. very, this very on going I at point, Yeah, any switch not probably to be specific this at we're

prior for think from I a those overall in anything we're you seen experience, good from overall, MSP two is statement perspectives. looks different seeing what that probably just really we've the not

Maury Raycroft

Got it? last question. Maybe very That's helpful. quick

dose data the study? in For month the XXX, look a additional have control to final three had patients randomized to at in the two XX chance cohort you for inform the

AJ Joshi

in for let's presentation week time. mean, I the wait a Sachs

Maury Raycroft

it. Got

taking questions. Okay. my Thanks for

Operator

you. our Sachs. of Goldman question next from Richter line And with the Thank comes Salveen

Your line is open.

Salveen Richter

secondly, what conducted from Could just to as the patients run commercial are? if changed us for range to help these tab-cel understand the and variability XX your with you. clinical projections on afternoon. here, XX%? tab-cel given trials could in EBV opportunity you data remind you have Thank they you then is Good us for And or your on to positive what

Pascal Touchon

the address you. address one. and second Thank Kristin to Maybe might Jakob first the question,

Jakob Dupont

Yeah.

question. When actually seen the anything, So Salveen, look analysis consistency I having me the a impresses for that the the thank you is on of the this, data interim ALLELE, if data. thing at especially

So again, I think we've with in do patients the between safety study. what the the Pascal seen with we've very near now with studies. consistent XXX therapy collaborators previous as is mentioned, this And treated our profile

to think see response robust that's experience. the there's I I you think rate. very the consistency of consistency two-year look rate, the about this have and taken magnitude of XX% historical survival response there. categorize the in XX% also And to we would of think I I the at as I you point when well response, reflected is think deep So response also terms now -- rapidity in your still

a have Now criteria order study, where eligibility to with an the experiment obviously really authorities that's that's be to give convincing approval. regulatory ALLELE up tightened the us to we going to registration produce study, intense in

and prior the about number biomarker things, you tightly those the the controlled when of patient think, of therapy, status those positivity, within performance like study think I of really the all So ALLELE. are lines a of

the historical that And so similar rate us performance very the of we're the characteristics therapy, great to getting confidence. response other the gives a and of the is experience here which fact

we're say reporting the and investigator remind today the to response experience rate our I oncologic rate. radiographic historical will independent XX% and Now, is reads, that response the and in what XX% in

that study read of different from a more a but experiment, is you if efficacy see frequently, interim assessment robust But, standpoint, and in enrollment a point. this only on bit go rates there data I obviously, data down, very here, an where from assessed, rate is robust independent but the independently is the way So this. is with a XX% the what standpoint, will also the patient response to anything, is response ALLELE little not say

Salveen Richter

you. Thank Okay.

Pascal Touchon

answer to there? we the question want do the do see Kristin, about how commercial potential you

Kristin Yarema

thanks Yes, question thank you, Pascal. Salim. for the And

in where where we we and want thought we're commercial to So be right would we assessment. of be terms the

in profile we've of add entirely a how So, would just data, consistent been thinking about would what commercial our is heard reiterate Jacob, the opportunity and that for kind I of just interpretation represent tab-cel.

continue believe with over of a at the and and heard of our not cover very for proposition treated simple therapy. So patients And a this to will are hundred are historical, -- evolves I about monitoring. to simple infusion, like from strongly our being patients we've to hours there we the several an profile response and between in the patients study, the data that's the we historical rates, of XX% expectation established, and that time tab-cel, the settings value pre-treatments benefit that And and who believe that minutes, in of ALLELE. with a seen two XX course we'll also is, the very convenient emphasize, seen, to patients U.S. as in survival we've variety very that's course, is patient of And be see how we've deliver safety required to ability carefully therapy the of and it's therapy to would to the very care but watching needs take, IV for launch. its five how the truth well. very

the very tab-cel. to continue we opportunity for So be commercial confident in

Salveen Richter

you. Thank

Pascal Touchon

your answer question, Salim? this Does

Salveen Richter

thank Yes, Pascal. you

Pascal Touchon

Thank you.

Operator

Tony question Thank from Capital. line you. the with Butler next And comes of our ROTH

is Your open. line

Tony Butler

much. very Thanks

XX%. of brief robust I'm statements very on ALLELE, points a end respectful about made Just very around for question that.

Are a could XXX, for And Expansion? the at curious XX% to -- have benefit I Thanks the do Open could to cohorts in claim much. be the good would you if and patients enroll? continue well. I in they say patients same recognize a just to - look that XX Label but XX%, patients with enrolled over have to I'm second expect you think that's -are are expanded XXX, Label would you Expansion? as care, standard patients continuing be I on in you Would you If of very could tremendous patients that that mean, that just in today, expansion so that number I be out? Open in who enrolled to cohort? of being to more there XX might thought sites be would want robust, would

Pascal Touchon

will for way question address Thank do see take first data you, ATAXXX. the we particular these that AJ ESMO. you the the about on to at your question And want questions. presented Tony Jakob, we then

Jakob Dupont

Yeah, absolutely.

question. So Tony for thanks the

really they First substantial have a patients and needs. unmet with these and medical foremost, AID-LPD, PID-LPD

these patients who patients and really again, are at these therapies approved all. are So no available have for therapies there failed

I who's risk inborn when have actually and think an the quite so giving an getting so other at patient putting chemotherapy for you acquired that immunodeficiency dangerous is these be can patients immunodeficiency And infection in forth. or got a them cytotoxicity point terms of

know, you then So And with that's actually patients, I lack meaningful and result going their for response that, at, XX% and we option of of patients, a looking know, type unmet immune rates, XX.X%, to is the a you to not system free these achieving these therapies then high of think order on these suppress very the the further. for absolute available need, know, patients. -- with approved for you chemo this think

patients, think clinical I absolutely. so benefit for these this And is

Pascal Touchon

to the answer Thank number want of about you. we expect and And patient AJ online. do orally you

AJ Joshi

So just to study add a is bit extension. of label clarity, label the open in an it's open -- exactly

enrolling So study are cohorts that that only four really people described people in that previously. the were we've from the

and who had move of for to potential moved a patients patients out one really label apart go would to And that open the in right dose cohorts, on extension. that the that looking not purpose, forward country who the were of couple XX study. So into at from really patient decided earliest we maximum actually the

really control has the in then you So into them in want therapy. else that everyone Probably as to we other randomized Any into declared moved that their might interested new moving label trial, are they actually on forward imagine. extension. interest to patients move study, open

Tony Butler

very you much. Thank Absolutely.

Pascal Touchon

make we one ACTRIMS-ECTRIMS presented months going the is, And and to Pascal have so. in there's at more presented reported, the that's going you XX as data comment next we other But there. be patients to over know, handful ALLELE articulated, we've be maybe of as I or a to

more well. for see data as you'll going go patients So forward

Operator

Thank you.

next Our from Michael with ISI. question comes Evercore DiFiore

Your line is open.

Michael DiFiore

could Thanks FDA, they did already status just question. may guys. whether approval if one up yet. curious, and Y of could very on why and sounds It's to dig if they've it regards little top not It in dose X see accelerated more did next with impact up incremental I'm X very it just sounds data And on I'm us But to I at like still Z the occurred didn't bit add on the taking cohort just today of And and want my to how even follow patients XX for improving the Hi, cohort X randomized IMS? terms follow curious your been accelerated with ATAXXX you cohort to much wanted to for I presented a Thank And and to it XX possibilities that's to the week. that, control months in pathways. and whether portion sustained future be undecided discussions the trial. because of like you're patients line how – approval disability the at remind you. a on exploring months, Z question. show possible as Y discussions answered.

Pascal Touchon

are we Thank I protecting you, which give decision short of embargo start data. will from because the there. your detail getting have AJ beginning data, Mike. going regulatory announce you made to we the the week the for the mean, the the next question and doors, more on are have I’ll we And discussion on answering that

interactions? regulatory you be AJ a on have the – the to on any so week just comment just So wait clear, to

AJ Joshi

have know, questions end given, we've we from that. FDA. in We year of significant Yeah, do the them communication response a as pathways about. the those protocol of this from around just actually from the We've perspective, detail, fairly we submitted expect on had of by timing that really you all that expedited and the we've talked with variety

probably would to So we communicate year. presume would that early that we next

Michael DiFiore

very you thank much. Great,

Pascal Touchon

you, Thank Mike.

Operator

questions gentlemen, I'm participating. is call. further close ladies And you Thank you. for and my pleasure Thank any not the showing to It at this now time.

disconnect. now can You

Atara Biotherapeutics (ATRA) 10 Nov 202020 Q3 Earnings call transcript