- Earnings call transcript Q3 2022

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Operator

Good afternoon, everyone. Thank you for standing by, and welcome to the Atara Biotherapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] Please be advised that today's call is being recorded.

hand Investor over Atara Relations to Vice Eric Biotherapeutics. like of President and I'd the to call Hyllengren, Now, Finance at Please sir. go ahead,

Eric Hyllengren

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

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

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

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

Dr. Pascal Touchon

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

for Fabre, the in of commercialization European preparing agreement tab-cel's With a T-cell landmark for update the and meeting. ever of health believe runway. deliver I the be Europe on by excited received off-the-shelf CHMP extremely and Ebvallo care end name therapy. these this just we significant as the such progressively approval have proposition can and with QX unmet medical on accordingly The the our progress high few on is very anticipate positive as as therapy indication to the opinion first and this We few was significant indication opinion a we launch pricing potential that Ebvallo the to would approval survival. Pierre need double-digit payers Meanwhile, under will to the XXXX. positive We partner, patients a Ablo to commercial year. for track PTLD an of patients, EMA release ample is will one believe October systems. in first public Fabre, Pierre give obtain are pleased Commission first dearly in median launch very EBV-positive Ebvallo revenues its weeks value compelling Atara's European of and with tab-cel, to addresses in our U.S. allogeneic ultra-rare a highlight Ebvallo CHMP tab-cel trade now a contribute This disease an in cash like no with actively months royalties

clear requirements Following for a specific held meeting team BLA recently CMC senior with constructive FDA, discussions on A culminated that model three the leadership, the CMC with Type including in review and we a guidance submission. agreement

scheduled the request for on a potentially meeting has discussed clinical is clinical align to granted B Type a being pre-BLA and pack prepare requirements data been and meeting. addition, In

conference potential and the Phase will safety expect remeeting BLA with and EBV-positive meeting further EBV-positive of present we in the At with relapse this in PTLD XXXX possible relapse we additional FDA, to interactions QX tab-cel. guidance and submission. give updated results a patients ASH on transformative analysis of progress PTLD ALLELE refractory further follow-up in Following to efficacy the X the interim study confirming longer December,

a EBV-positive moment. EBV-associated will solid in with data more tumor. type a of patients Jakob this new present also details exciting on in We data leiomyosarcoma, will provide

tab-cel, partner further started runway. in commercial additional to we Entering extend into will our partnership inflows, could such a and a U.S. have investment for cash further the seek avoid provide cash Finally,

We million are the a that year potential opportunity U.S. per confident indications. over for sales significant tab-cel with multiple in business represents in peak across $XXX

sclerosis. transformative X At imaging and we study ATAXXX, new therapy from XXXX clinical from to conference, the progressive of forms ATAXXX in extension on for Phase of our those open-label MS. presented potentially MRI the Now suffering biomarker progressive ECTRIMS multiple data

addressed less lesions. CDI significantly in CDI updated two results These improvement, biomarker brand's the open-label confirmed remyelination patients data total years, improvement imaging follow-up including or may support with achieved durable natural meaning the of Remarkably, disability brain such stable improvement time, Also, patients atrophy expected decline an over unenhancing connected changes, data the a demonstrates would with for demonstrated who durability disease. to underlie ATAXXX. four months once New have represent NMTR structural of also ongoing disability to profile course or potential associated no in with transformational the achieving CDI, confirmed up increased from EDSS, extension to which up achieved. in patient disease, maintained XX stability relative

versus EDSS enrollment for XX evaluating patients approximately ATXXX patients, on disability based placebo endpoint the confirmed Phase planned non-active by improvement reminder, be end the XX at July months. of PMS the X primary readout of in of included study EMBOLD in at are study a As to

communicate progressive new extension, published studies fast Science openable our with our confidence from We to XX X Nature OLE further the this a of Phase to for patients. FDA, readout data expect and year improvement study clinical deliver MS with support track two ATX the all, this landmark in data designations together in October in our and two and final in this transformational possibility to XXXX. ECTRIMS All

of we MS, We Meanwhile, are creation are eager exploring October potential continue ATAXXX. in to companies maximize in as potential truly partnering opportunities we'll could opportunistic that excited endpoint to a be XXXX. primary and EMBOLD changer by reach with the biopharma unique ATAXXX the readout in potential value game

to like Jakob Now our financials. to and give would strategy over portfolio before to more details Jakob? I our on pipeline I update on you an provide hand

Dr. Jakob Dupont

Thank you, Pascal.

As CHMP in recent about opinion for Pascal we the excited mentioned, positive Ebvallo are Europe. extremely

We ever are closer to advancing T-cell receiving approval Commission first-of-its-kind European off-the-shelf this therapy. for

with to that company of next now progress regulatory have also believe overall of U.S. most the XXX any in platform our and year. evidence therapy steady more to this and safety, clinical T clear than has of date. making cell We portfolio, front say positive validation cell on QX for provides also decision we're the expect patients efficacy which EBV by to more the allogeneic encouraged We're treated and

we patients are will follow-up. updated Looking data XXXX potential in Phase ahead to results with and efficacy was last X meeting The the consistent be tab-cel in ASH PTLD. ASH the now with published of of safety to study the in ALLELE transformative presented in longer PTLD EBV-positive present that the additional December, and relapsed/refractory week upcoming EBV-positive abstracts

and month, urgent was patients XX.X% XX.X PTLD. overall data just response this impressive the was opinion new of time XX we the responded Specifically, duration these The The with of patients. SOT response and is the after was response oncologic than trial needed patients to received. survival median rate The non-responders. was clinical positive These independent having response XX with emergency radiographic months the an response EBV-positive ALLELE that XX.X%. impactful median such for months, rapid survival an oncologic overall was longer for one who were and and HCT after XX% in rate CHMP was very at size sample by assessment as

Additionally, lyomyosarcoma access in one who present updated studies have therapy. at with ASH, EBV-positive and will two safety open-label data received at we single-center multicenter and patients efficacy expanded program from least

Now infusion solid reported in benefit rate objective was with overall transmission rate profile with remains indications XX.X% each and We tumor, with multiple tumor and of geographies. and these cytokine potential of support of benefit thousands reaction its syndrome, believe and In across reports lives graft-versus-host previously tab-cel median the to estimated of the data data from patients treatment. clinical survival no all the this reaction, was to these the related months. the consistent disease to XX.X% an release difficult-to-treat tab-cel of safety rare continue response XX.X diseases, studies, new of year tab-cel or infectious of floor transform

this potentially our cells brain ATAXXX, B-cells debilitating is that for -- to patients mature treatment that with The nature publications sclerosis, disease. secreting plasma cells we towards B therapy in these on for transformative multiple EBV-infected progressive recent reactive for targeting that antibodies. transformative approach finding a Now generate show antibody into those a EBV-infected believe validated

drive thus can autoreactive addition, In and B cells stimulate EBV-infected chronic inflammation. T-cells

this of recent these around our together, therapy. support potential scientific advances the excitement Taken

the ECTRIMS, noted, Now previous potential data as presented to We analysis data October in final be next and patients double-blinded the approximately on MRI of of the readout OLE transformative from look our Pascal XX primary who EMBOLD of study the reinforce the Phase data, in data X further Phase will new top ATAXXX. belief updated placebo-controlled of included X forward the in randomized at year.

year escalation well. product clinical candidate to enrollment MSK Memorial that voluntary respect after as X by on autologous Cancer to and to earlier dose this fatal want CAR-T pleased is partner provide Sloan-Kettering the resumed mesothelin in therapies event due which by as ATAXXXX, to being serious Center, developed I a one a we our With an reminder, report pause are Now update the Phase study our our currently has conducted patient.

a December at year MSK this Phase in for program, for Additionally, of data IO provide this expect the update to ATAXXXX ESMO we X Conference.

are expressing for our CAR-T we malignancies CDXX. potentially advancing ATAXXXX, addition, allogeneic is In best-in-class which B-cell

memory Now we manufacturing T-cell to FUJIFILM maintaining filing Diosynth anticipate optimization strategic appropriate IND suites year. in optimization next and the in the runs manufacturing QX scale-up GMP while progressing completion partner, ensure Biotechnologies, following process manufacturing a is manufacturing of phenotype of of process an our now unique

shown on CAR-T process studies, of preclinical we're the shown autologous need. T in XX ensure of to manufacturing has to As manufacturing products investor to cell survival a memory where an reminder, ATAXXXX ATAXXXX an optimization from in the existing for phenotype on part which and preclinical optimized unmet medical activity This of address benchmark deck, updated overall enrichment high model. differentiate Slide a approach is the outperforms overall it using as our robust a

on associated data cell and clinical response. meeting is memory ASH candidate stemness that autologous at ATAXXXX with of CAR phenotype T and recent CDXX therapy. focus response rate Upcoming T this presentations showed improved of is phenotype supported autologous with by more of for an therapy product durability Our preclinical CAR-T year's CAR-T clinical

with ASH favorable clinical CDXX the Dr. domain and invented co-stimulatory XXX from new Michel response autologous , the associated another Additionally rates, XXXX durability containing data safety. with by is abstract CAR-T Sadelain

is MSK construct. from into licensed have we that the domain costimulatory ATAXXXX incorporated XXX the reminder, a As

We are off-the-shelf CAR potential to gene require particularly key best-in-class the include excited the efficacy, persistence cells, CDXX and safety does to HLA editing. differentiation. These accessibility, this clinic has the allogeneic since of ATAXXXX not TCR or CAR-T EBV several bring program ATAXXXX points the and of T

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

Dr. Pascal Touchon

Jakob. Thanks,

to Under top EC our the million Atara Now Pierre an subsequent an announced an $XX receive Fabre. upon will milestone transfer updated Fabre. with of agreement, XXXX, on approval commercialization filing financials. we agreement MAA cell and payment additional In to September additional under Pierre near-term this

Fabre For regard expected that quarter plan cash together cash million reduction quarter will future with cash with QX operations ended of with sufficient fund to operating potential runway, XXXX. burn inflows approximately XXXX, in cash. third the cash in we and the third $XXX believe and the into this to Company Pierre balance, We our be the from position of

we of restructuring in gratitude truly for have to to that innovative done. and staff recent unwavering on patient now extending operating seek what implemented, to XXXX over track plan. for transform our Operator? fully the commitment you turn contributions I my Atara to for like the the patients to I advancing would our need. part medicine operator to for in reduce Following call. cash Thank lives significant are will all sincere according you is the burn to and all beyond call their by Q&A now their in conclude we

Operator

you. Thank

conducting a Thank you. Instructions] now session. be will [Operator We question-and-answer

your Our Syed question. first from proceed Group. question with Mizuho Salim with is Please

Salim Syed

I guess tab-cel. on a couple for me

also format maybe factors the any So logistical the would then potential also if Pascal, any take And revenues that providing you finalizing on having And the Europe? curious on what point gating 'XX, U.S. sort on partnership part first of plan some curious place? commercialization? around on hurdles T-cell guidance maybe of having side, what you just just EU at U.S. or in the the plan for allo in of or 'XX that tab-cel for first product discussions are the

Dr. Pascal Touchon

Thank Salim. you,

the give which I regarding and 'XX, Europe. launch, So very important is QX we received we stage with with more strategy, too said, this on to and is care say idea at on understand we and time starting the at Pierre have Fabre But of point which of brought to any we Europe, make in of course, is relevant the patients, it's from are fully society have price think launch. guidance which, very aligned any to Pierre Fabre that aligned we as a is to revenues value according early after not At the approval physicians type this coming to pricing the their about But comment pricing, for planned health to system. stage, we will to any the we transferred pricing. planning what and

so product the launched the product or 'XX. after time We is able to be being will the in do

institutions time, at is, don't launch. what on in more we really like many sense the if needed Now call hurdles, biologic therapy, It regarding a that logistical but side. a is that cell cell But course, our we product few on details, give will, this of physicians that see the launch. deliver basically you already made. of the is an of the where it is to therapy, product cell from is treated inventory allogeneic a has the the days to just or therapy ability being patient which shelf within having been that

course, clinical access well years So in as do there already of couple Europe a as now time trials We've aspects to expanded of key we the have started most logistics again some patients. and that of number treated of tested of since is, we a ago Europe countries program. in across time

a used are the we -- the the few And days So ability to to we type and that transferred within that Fabre. deliver have Pierre logistics knowledge of know-how that to in need to treatment. patient

able that we're be that confident So to will very they handle very efficiently.

and type It's to partner to and be finding U.S. partnering of question seek type I on execute right think, the the right prepare only or the for the timing as said, a split to on about have Now front, value and and to I a we partnership. for partner, of also started launch. be not financials. negotiating able about BLA It's clear the of the submission product the the approval finalize

have derisking interactions that it timing answer we the with some is FDA commercial also the activities there your process submission the meetings value with ways, of is while in in the BLA U.S., maximize are that Does in parallel fine-tuning question? terms very we of of the of significant, run exact to submission the some in right these we all which tab-cel could ability the the partner progressing finding with and and, So that believe BLA FDA. of

Operator

Thank you.

John Our proceed Please next question Newman is with with from your Canaccord. question.

John Newman

study distribution a you the more have kind looks could Just the of have formulation as time the regarding how product follow-up curious of how for you clinical bit number commercial tab-cel patient with comment material? patients Just the might and to you that currently much curious, also versus if there? commercial treated little across

Dr. Pascal Touchon

Thank you, that take John. Jakob, do you to one? want

Dr. Jakob Dupont

And question. Sure, for the Pascal. thanks John

treated the we to had into FDA, and with the these clinical see commercial last for So to material. and commercial discussions the material good they're as certainly the the clinic, year you IND antenna data patients interested then this know, filed we put amendment intended with

So well. that's going

that these going to we've comment FDA not trial clinical possible we previously, use a trial. supportive of at treating new But in previously proceeding we're forward tab-cel a patients. and had announced clinic. we a And are the we've ahead and present clinical need patients was point, the commercially without could the -- process specifics conducting I dialogues on Pascal? follow-up. not of number new about And of are amount point. submission that. with and the been constructive for and commercial patients the that time to We again, treated mentioned going this commercial with this patients treated BLA to at path the FDA but the give again, or the to we at say, have treated how we're But as We've this follow-up will not duration many material of the

Dr. Pascal Touchon

the has past of that a the for a Yes. six and on product. mean, not months with with the side, treated and about requirements time. patients settings FDA to what the done that of one at add population typical patients this Suffice to different treating response duration of I No, patients nothing in are regarding been well, commercial followed things this say we with in have the we have stage, follow-up, to terms the to comment my response. going product are commercial poising was But new for are in exact the to

John Newman

And you you in just potentially bit. label or the utilizing well do you've product, receive were the if multi-cohort or give commercial to in broaden the as with requests agency to as the thought also, a study perhaps -- the curious satisfy currently patients might those discuss if the that about patients future you perhaps FDA's opportunity

Dr. Pascal Touchon

of only the ALLELE safety of product, the chime course, safety study, I the all imagine, I setting, future program be access use of One be point in. the at but the required patient you there single product indications the we for of you commercial use, useful is and potential with in can start, that Maybe from study, for looking to aspects. there. is terms and of assessments, specific that even intended are efficacy albeit two view, that is, or in Jakob, pivotal data not From type point an indication, in a view any will useful Yes. mean want BLA of are might as in filing. expanded it of more terms base FDA pursuing

indication. focus So add? that in the efficacy need Jakob, data where to to will specific anything we that's on

Dr. Jakob Dupont

Yes.

spirit I well I think Pascal, right. think but that's the do summarized. is

for going We for a assessment patients risk-benefit all they with is of certainly variety -- material a of ultimately intended in informative these settings would are commercial with treating FDA this patients make be treated is the to and that the tab-cel.

Operator

you. Thank

question next Romero proceed with Please with Tessa Our is JPMorgan. from your question.

Unidentified Analyst

is This Taylor for on Tess.

were month? that curious, what and is we So resuming? year? was presented that at to data size the the fatal ESMO details And will be we factors SAE on the earlier this just will in MSK particular, of what the And led on more scope reported get the ATAXXXX study

Dr. Pascal Touchon

Jakob, one? do you to want that take

Dr. Jakob Dupont

absolutely. Yes,

made the to up conference and there. be So of the IO dial the ESMO the and year intended the be end will presented target certainly coming presentation will before data

there Now cohort. patients because up here to the presented will of patient the that escalation dose on first in be third enrollment, hold

of and will that we author this were safety fully was be some -- should type be the slide where and -- investigators the very that illnesses still clinical factors again that of was of presentation agreement information on up by is the mesothelioma amendment but by the of part that start treated once Sloan as in on an previously patient. Kettering. going presenting trial to we had Memorial that again, particular work comorbid the and extensive led particular And for as data anticipate, an And provided the going the PK amendment trial. of also lot the FDA that assessed the could suspect. terms was start that the FDA. patient There's FDA a who submitted protocol there detailed, at work be to proposed that was well other of where refractory who and So also And once an enrollment created FDA we autopsy to putting There They patient, the that was translational patient. accepting that included really workup data, we've information on again, including some the presented. potentially degree again presentation, together there's the FDA enrollment to agreement data expect for the the the

Unidentified Analyst

accepted? Okay. able on are details And you more any the provide amendment to protocol was that

Dr. Pascal Touchon

Jakob?

Dr. Jakob Dupont

Yes.

that So were some the protocol terms details study once be would of again. amendment, the of started in the

was agreed at and was dose. of Now two the what resume the the -- patients at cohort would treatment that dose study the

return of already treated be the So, three dose to six cohort at that and patients cells had there the of CAR per more T that been second would cleared a kilogram.

this is a treated we'll who quite a where, patients of including also so from was So had see information there. forth. COVID treatment, as And eligibility little a of bit criteria checkpoint a received amendment different of of I more there lot couple inhibitors, the confounded here, patient mentioned, and

was was would So that checkpoint requirement of made. the patient I that therapy. changes before the were a there those of there therapy trial bit was a with were predominant CAR-T longer the a the clinical say treated inhibitor washout on

Operator

Thank you.

question next Nadeau Cowen Company. your Please from proceed is Our with with question. and Phil

Phil Nadeau

A questions. few clarifying

simply pre-BLA meeting? meeting we meeting, the will meeting happen about the on your the meeting for First, the time meeting B and next that's after Are correct Type pre-BLA prepare Type at is a that to the FDA. guidance B some with

Dr. Pascal Touchon

pre-BLA meeting. and of I to see B be case. the package patients the meeting will -- follow-up pre-BLA B, that's the to duration that Yes, number and to Type he data after align is the move the clinical the wants on mean really then and discuss of the Type the to in align

Phil Nadeau

pre-BLA the after B Got the presumably not year, meeting. of in Type it. And update QX next meeting, that's the after

Dr. Pascal Touchon

about we what being stage, scheduled meeting. Type that meeting is speak, we're as B a is this At the Yes. talking

Phil Nadeau

Got it.

comes the meeting patients Type of going to that to B with take requirements how you're of Okay. going many based CMC the clinical on data long complete you sense module to the for upon three Or how need? with And FDA? agreed the upon do you that dependent have with have it's is a been

Dr. Pascal Touchon

to I we No, from the filing, information Nothing independent about BD gathered surprising meeting. needs clinical so view what's is now the a very clear here. be for on. of and type it have needed mean, what

it's expectations. aligned So with our

are we reasonable CMC part. in but any time, line expectations not our time that's for the So frame that giving a with guidance regarding

the before item So on main can is a to now that the filing part. clarify the we next the think we BLA clear. give is the guidance CMC of really clinical very timing

Phil Nadeau

And for do you clinical is to that final? gating likely the Or gating? be think the parts

Dr. Pascal Touchon

We cannot comment on long that's discuss the with whether patients to it's other going to with be is relate gating how to until key so FDA the how for patients aspect how them and we of the type about have that because meeting do many and on. really we

Phil Nadeau

it. Got

Okay. commercial We And talk imagine a you for bit more filing. getting point rationale like for to U.S. signing me Can in for this It the the large a disease partnership the the on about you're a little wouldn't close PTLD. just then partner is at like is spend last the question development? U.S. too strategic in sounds

So can why about you a partnership more talk a would wise? think you be little bit

Dr. Pascal Touchon

Yes.

particular. there I the planning, indication in study label in case already part in then that business know, as multi-core as we followed first tab-cel believe the for is clear a think by additional expansion that the its for indication, of you U.S. are we

case business very clear. the So is

in level reimbursement. acceptable will you of We an We discussed work future with to know done we've of As a one prepare be pricing that launch particular the had for price terms but significant payers. know, health system. care level in that

achieved unique will of already a the the be product, into in have situation We having that year. implemented XX very next fact,

payers, and medical of where prepared. the So management launch all work at well really affairs well reimbursement, of believe the We've prepared the the account focus we that mapping all centers has be also key should time. been

this and all an really launch being EBV. about linked with most as competition is significant that are a like And clearly a in transplant when medical product the ready. EBV aware in disease cases. positive lymphoma in ultra-rare of now clearly for very that of there are unmet all an post And the patients So it's need, PTLD with is patient, that. Physicians that patients tested identified true it's no

the few new is of be stimulate going going key to in efficacy ASH weeks significant for of Again a at data time the weeks, a the physicians will like patients of of And ability to these of bit to about very the important. data is a speak. So as awareness life terms the be this we progressing more that and to with the couple launch, of than awareness physicians is of of example, present weeks, and at a a safety. treatment tab-cel in couple transform the

scientific So that convincing, continue all we that of proper to preparation done the and data by that launch is Atara, are of communication been has sure the make believe. there very we

medical and due and handle start -- to investment there, could breakeven situation before to that full believe rapid to profit unmet commercial be to the relatively typical profitability some have lack competition. population need team we this to then penetration the the be of you of and though and Now that even being require the able create said, implementing a still medical an the will launch launch

at that partner of is a that XX we strategy And a And with to some market already a can U.S. from think we has allocate than upfront. to a it commercialization their us get as with level -- invest avoid in therefore, we've disease cash some point for that inflows then also the view, that that partnership the So commercialization. the from rely corporate for million resources a further to to that leverage for that and, area. view the And as deal know, is Europe you commercial on proven based they have on to will and of advantage better much U.S. when corporation Europe could larger point to particular signed we be structure that structure launch. in

to So the that that will question? the have get and are extend developing. Does inflows to we of avoid us resource cash some are programs CAR-T for also help confident that we continue to value it your to allogeneic the especially or creation to answer our commercializations we opportunity cash possibility here allocating runway

Phil Nadeau

Yes, that's very helpful.

Operator

Thank you.

Our question. next from Ben Please with Stifel. proceed with is question Burnett your

Kailie Briza

Kallie how if opposed I update, to an was this are that a think, I ASH. for in going they're Burnett. many update just are received, to program? quick of the patients also Briza patients slated at many on FDA. as And to Phase just that be had is maybe of give updated these patients you how these of how idea ago this could a Ben previous many us couple had This X actually, for years question then this curious on ALLELE update about guys new the we maybe the of new I

Dr. Pascal Touchon

Okay. Jakob, can and in. Maybe start, I chime you

The one clarify just we to year it ASH fact, a last update on XXXX. in ago, was was, gave Just Ali point.

of And now So it years It just couple ago. last this released that was abstract was ago. based update new a week. not year is on was the a

European that submitted So level regulatory important And can because in part the these of the opinion aspect -- you what extremely Jakob? and the that I say maybe, data. at that Jakob, positive comment getting was are of number will the on CHMP patients. regarding the

Dr. Jakob Dupont

Yes, absolutely.

the this do that here. had have to release those in And remarks, is We're in patients patients give relapsed/refractory and are initiating patients. little overall from presenting of ALLELE that you look PTLD mentioned of XX rate. data I at So we XX our press XX.X% in a those it X now obviously, of but response been in my of evaluable also total today, just granularity, EBV-positive when response captured as Phase And rate post-HCT. a from study,

And median here XX obviously, rate overall months, survival patients ago. response at overall you XX%, months response survival SOT response of survival. we an then ALLELE XX from that high responders these in is response XX.X those mentioned, crown positive were median patients, looking were And to the and XX then X XX.X% of the or the had need. which very the and if is of few really that that Pascal somewhere was And HCT, have patients again a high median particularly rate responders. led SOT population a again, the patients look of so data patients out of remarkable at MAA those unmet for the as again, months these data patients study a particular post X.X in quite a rate, of X So remarkably this opinion rate you which, between you're CHMP filing jewel overall weeks when and consider just were had we

So really these data. remarkable again, pretty are

Operator

you. Thank

question. question is Please with John Our proceed with from Evercore. next your Miller

Jessica Hui

A of is This questions Hui for on me. Jessica for John. couple

on pharma could extend on range also, then of ATAXXX, possibilities tab-cel? submission. And the meeting said partnership plan required then this give First, for lastly, how that cash on package for for just clinical bit large with data? clinical you BLA not are U.S. FDA much data a you partner? on question interest? necessarily may But expect potential the there you new tab-cel, updates a to potential could just requirements So to what with any little new color a Phase runway commercialization now discuss are be more And just a X

Dr. Pascal Touchon

take two? I'll first Jakob, take next one? the do want you. you Thank the to

Dr. Jakob Dupont

Absolutely. sure. Yes,

to without product just have that particular over submission really senior this. some and FDA I summer we for constructive well the commercial of the was and so Pascal of between the got was, FDA this of a reversal, say, And again, sort mentioned intended feedback conversations to to as management new summarize these the that the Atara at were part we version need within latter we process of the So feedback into a with which obviously, mentioned, I But we as FDA, would clinic did, the the commercial with in of the February, status clinical here got could BLA version that if back last there path tab-cel. the put trial, we year. be is possible use had

experience. we're gaining So real clinical

from with we the what well. clinical product commercial leverage but they discussed, as this proposed other also the study, which, intended to we pivotal that again, the well as embracing patients the concept treated agency, is So data in we sources are from as can

BLA really clear quite other this on very agreement A we and the and guidance impactful well. we potential had that the was recently the important is have Pascal the mentioned this But submission. a and the CMC requirements as meeting, culminated CMC for that three specific So, from with Type FDA meeting FDA module

if the source as feel over hurdle, of we a couple through again, years. cleared which been major last really have discussion CMC the So has of

clinical discuss Now we meeting. leadership and FDA also leading data mentioned clinical B have Type meeting, the the the by clinical that we actually up we on this have an suggested requirements upcoming potentially align package pre-BLA was to meeting and this that to actually

be is experience, patients again, in with actively -- the material, are clinical PTLD the and -- very And this leverage clinical the clinic have we've arguments, over to fact treated very going treated shortly. tab-cel XXX to close that approved XXX a to with treated we've well. going have we as certainly So patients preparing large we we in we with Europe patients again, but those are and discussed

quite we So is that think that, impactful. clinical experience

preparing very treated So as clinical anything experience well contents with that clinical the -- Type argument be meeting up, interesting clinical on to robust B hope between coming FDA an where, going as again, the this of where commercial agreement further our gain that package. other again, are patients quite Pascal, add? to to we this the we intended is

Dr. Pascal Touchon

clear that. that's think I No, on

Jessica, that. to your we're So the on going on not two cash for questions, extension, to comment other

regulatory emerging Europe the product we milestones, PF plus had very very on both upfront and the what with are million $XX double-digit that I partners plus which as at as we We with, maybe well the markets see could for other partner term Europe I potential royalty. a and with few was a say significant a time six this process sheet discussion think best starting successful in -- sales

but to good managed partner, we very deal also have the Company. a for So, a good very

we'll, U.S. can and the much I'll number you is let in to mentioned peak regarding the this the we very is you situations particular than type U.S. business decide in course, how of as large opportunity And it million business Europe, is when compared opportunity that views over in replicate to of it it sales the we our in is, Europe, $XXX So And of think significant. of try a but imagine, larger think you there. about there U.S.,

product So follow-up in with its that's line first significant going value indications. the to hope, indication be, in and we the of

turn fund activities said, of types this also to QX time being of in Now Company or last terms in we've the of the progressively be the through into -- to said that cash different runway is able stage readout have of year at And of for the of to reason XX, in end inflection EMBOLD, is one a Company 'XX. point some cash 'XX. which potential the the beyond significant is very October the value

intent. that's So our

now, of still We number are we support activities Company. into a funding we can but the of manage to have QX that 'XX the

the readout, we'll and than important grow which but further QX beyond cash believe that. opportunities is already have much 'XX, we notice, it's We EMBOLD to to have

point have on shareholders particular we are, it because giving the as in EMBOLD from Thank were Now various partnering, We be to potential our the the potential value you before with the on readout, if significant of value that say sure XXX make we readout very just value But is not important benefit very to reiterate any 'XX. as of want October EMBOLD is we discussing inflection to partnering value are will future we what the in that course, we depending update. consider recognized well companies. split that much. most

Operator

you. Thank

proceed Richter with your Goldman Please is question Salveen next with Our from question. Sachs.

Unidentified Analyst

XXX, the for for This there? confidence year give X be that Salveen. you could is Mason Phase might sufficient On data what on one

Dr. Pascal Touchon

to you that one? AJ, want Yes. do take

Dr. AJ Joshi

Sure. of of by you XX-month improves that Thanks really disability EDSS, frame. within the confirmed first look improved sufficient for saw from disability question. the conference time year for the The them where drives for Phase data all that we when X one being the improvers almost

As we is a -- you study the are study. two-year know,

are the we for EMBOLD patients large confidence a point. But one-year occurred have time readout. that majority endpoint that following time really, that, XX-month first good of be improvements So, beyond in that that we because the frame, will

Operator

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

may You disconnect. now

Atara Biotherapeutics (ATRA) 9 Nov 222022 Q3 Earnings call transcript