ATRA - Earnings call transcript Q1 2019 | Atara Biotherapeutics, Inc.

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Atara Biotherapeutics First Quarter 2019 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this conference call will be recorded. I will now turn the call over to Dr. John Craighead, Vice President of Investor Relations and Corporate Communications of Atara Biotherapeutics. sir. ahead, go Please

John Craighead

and questions. uncertainties providing due forward-looking for Dietmar Ciechanover, Good progress. from XXXX differ and Update Financial listeners morning, results the press Earlier operator. first the from Atara those XXXX making note will remind to Executive could or the Isaac Investors at atarabio.com. We section our Dr. this quarter Conference and like the statements. implied release then call your statements company's that by to management materially to stated Global forward-looking First risks be and call R&D; that today Media this today's financial Head press release open date, a issued Chief Quarter We'll Results recent qualified we is results by Chief no overview would Actual comments by morning, you, contained and as statements today's in made statements of forward-looking & available company welcome with the President Dr. company's the Berger, Dietmar operational these Utpal Isaac joined everyone, and prepared the the Call. an Officer; Please cautionary Financial associated their Thank in in statements are are on and business. Corporate and obligation the release SEC filings. to entirety and of company's These with undertakes update begin statements. the of and I'm press Officer. Koppikar, These company's

Ciechanover. Officer to Isaac? over and Isaac Dr. Chief like Atara's call Executive the turn I'd Now, President, to

Isaac Ciechanover

for joining Thank you, John, thank and us this morning. everyone, you,

our our of sclerosis major tab-cel, Head provide upcoming an Berger, advancing CAR a important immunotherapy milestones. and our I slower Phase make Enrollment Global more On Dr. discuss an programs In studies detail, this patients patients update first and of today's factors for than ongoing development tab-cel multiple to identify clinical across proceeding to will our are status studies value programs to in similar PTLD. three studies our clinical The T-cell in challenging our to other R&D, our diseases. anticipated. but provide on progress make we will program. T X continue recent that is moment, EBV+ next-generation like condition and call, would progress enroll in these rapidly drivers: update and ultrarare on with progressive Dietmar We

on Dietmar these ability to outline We our are that shortly development plan. challenges implementing to successfully aggressively our strategies execute will in address clinical remain confident and

previously, strategy EMA we PTLD, a tab-cel we tab-cel. discussions us which submission. expedite allow with As a have regulatory mentioned development the patients are for global on align with regulatory to is align and objective potentially may our also to for The US in EBV+ on plan to FDA

year. the initial program of new regulatory at are we We for the our the of the development outcomes with ultrarare Neurology, and this with EAN, to to as ATAXXX tab-cel these this need often we and ongoing our Overall, ATAXXX Congress or later allogeneic safety so XXXX. view European find additional date and in including in treat far disease. track are encouraged efficacy and off-the-shelf, of programs Phase with We our remain critical to multiple discussions sclerosis. June options this Academy In for half on safety expect of our additional continuing ATAXXX first results progress parallel, of results present expected and the advance to acknowledgment we regulatory to life-threatening of year progress, patients X

AACR checkpoint with next-generation proceed a mesothelioma and collaboration clinical CAR results Annual the PD-X immunotherapy X for and their for Meeting. also MSK-reported CAR our patients XXXX Efficacy portfolio, results pleural of with T malignant presented In for with inhibitor mesothelin-targeted patients tumors expectations. Phase chemotherapy our addition, will our lymphodepleting for T positive safety at solid exceeded

Following a mesothelin. response data subset for development patients. proof-of-concept will the are in novel tumors. treat observed our MSK the solid fit given results among the XX% prioritize of platform, CAR And T these of investigators T, rate a administration first with These mesothelin-targeted to strong we the CAR next-generation of

to with our the in an enter We T CAR expect be clinic XXXX. IND program to anticipated this first

mesothelin-targeted the clinical results June. development who updated call from in T Dietmar at We excited Dietmar? programs. like will be more to are would to also provide investigator-sponsored a update detailed over turn to study CAR the for ASCO our MSK I presented our now on

Dietmar Berger

Isaac, you, and good Thank morning, everyone.

additional As rapidly would and develop Phase patients diseases. detail some ongoing progressive that condition and patients the other like on with tab-cel this PTLD. I The identify earlier, our challenging of Isaac clinical studies factors provide to X EBV+ to are to make similar ultrarare for studies status mentioned in

the sites. patient and of during is of the course number window incidence requires study example, recruitment short of disease progression overall substantial For for a the the disease

tab-cel about treatment continue of prevention EBV+ and gain epidemiology, and multi-institution PTLD. These the initiated our studies. our to available experience we we were diagnosis, As program, advance when insights clinical we new not insights

patient care in depending the standard variation age factors there rates transplant immunosuppression, is example, local PTLD type, As wide at level on of transplant transplant of the of and including many an the setting incident center.

refractory beyond is that rituximab a EBV-PTLD gained high-risk patients studies patient leading In with one condition experience therapy XX these EBV+PTLD no organ Median organ our our years. the median hematopoietic allogeneic to or physicians population experience in following life-threatening XX clinical area cell need. patient components is the is high and a overall from interaction will live based patients fail in and a solid is and for EBV+PTLD year transplant, of work solid time, their days. patients PTLD rituximab At hematopoietic medical We cell during conduct short, stem two [ph] unmet transplant with our in the the with XX% to survival approximately with transplant survivor expected on with confirms regarding setting, the survival the families. in same have

addressing enrollment by We our identify possible. additional to XX network open and a with sites now potential leader as number of PTLD EBV+ significant early are to as thought leveraging aggressively patients continuing

SOT recruitment centers centers optimized social strategies the further detection, patient our including have advocacy, the key with our transplant close in We year ATT and last patient media referral collaboration by over earlier setting patient up both and settings. outreach and

with X European XXXX. initial both and based with to we importantly, which provides finalize to now and we outcomes the Phase align more plan for to time us progress, patient Conditional tab-cel the US window EMA year. flexibility our regulatory lines Authorization believe on EBV-PTLD continue we But We expect European by development, encouraged are patients This submission and with Again, updated on a the our last line results programs. X possible trends, current discussions integrity of FDA studies, half and addition, regulatory tab-cel physician early-access ongoing and for the top EBV-PTLD partially Marketing enrollment investigator regulatory acceptance of based results to tab-cel the ongoing Phase need this European our submit submission. To following strategy application plan the disclosing frequently ensure initial these under tab-cel of this the filing use the the in providing strong we interests is In open-label first in in are to submission. on single-patient patients company filing our EMA anticipates XXXX. see the and of now precludes

on pipeline progress we as both Moving CAR our next-generation have in made now consistent this T to our programs, multiple press release sclerosis and noted morning.

Our on programs in are track. MS

X Phase progressive ATAXXX this with allogeneic MS results off-the-shelf be expected study an at advancing EIN to in initial are safety with We patients presented June.

study results the second initial scientific safety half Congress in data XXXX. also that We present at to from plan of additional and efficacy the

half MS In addition, autologous the to expect of ATAXXX in progressive in study randomized this initiate year. of patients we second a

T to are excited about we immunotherapy next-generation our CAR progress. recent Turning programs,

Our Kettering X at T the collaborators CAR presented Memorial patients results Phase with in Center mesothelin-targeted in March. at solid Cancer pleural AACR immunotherapy for tumors Sloan recently positive

our planned XXXX. more CAR [audio a Operator? next-generation your Atara the Based of were ASCO expected XX% program in settings. and and activation ahead checkpoint at would of immunotherapy results the Isaac physiologic now next-generation mentioned, inhibition look in in the Using is this rate tumor on for presentation targeted to T patients, we forward in updated subset can ASCO at potential a call highlighting back by we June. a MSK's IND the turn our PD-X T-cell MSK to with different As XXX response approach mesothelin-associated solid and questions. CAR dominant CAR technology of take and solid an the the go domain we patients tab-cel for for next-generation with tumors an receptor are and immunotherapy negative MSK T signaling CAR novel prioritizing like XXXX. with break] offers encouraged mesothelin-targeted data, presentation T-cell development I

Operator

you. Thank

line open [Operator We the questions. the will from for a have Anupam of line Rama now JPMorgan. of question Instructions] any We

is Your open. line

Anupam Rama

much said on question initiation? is XX this the planning Hey, are updated just AACR. release sounds you and and another like this CAR mesothelin be here for opening the so open have the question. taking What I guys. PTLD think press Thanks On dynamic, enrollment time you're for sites more. Tuesday And oral for regional they're then on from site T, focus for going quick presentation to a there data the lines

Thanks the scope so new data of can be you understand So much. perhaps we'll getting. help the us

Dietmar Berger

you, We're extend focused and regions Thank opening Anupam, sites, is PTLD to Well, for and we the enrollment currently new planning the also the expand are planning Yeah. we're the US. geography. to and to regards gaining With other study the question. consecutively on process aggressively. primarily dynamics, to

centers not have these social collaborate referral site I'd the holistically, the this looking be from closely with transplant get and over of advocacy. is via to media, other, Those ATT at strategies activity we the patients and we're one up this, set recruitment to SOT out will because that have sometimes in year. slew earlier patient very both point patient a at outreach settings. detection, we only key centers transferred We that Looking last and started the

on able we execute So we will are to that confident studies. these be

presentation are correct. data Regarding AACR, the be current of have the you This an that you will at mesothelin at seen AACR. update

about So that. and the on cannot But say expecting potentially and the more we on we product time, more in details population, details patients point this at are efficacy patient safety. more

Anupam Rama

much questions. thanks for Great, taking so our

Operator

of the question Newman Canaccord. of Another line from John

line Your is open.

John Newman

morning. my guys. Thanks taking for question. Good Hey,

any currently to details. But curious. regard access the don't So data sound into I'm you additional patients. some I like with be either know there mesothelin the from divulge you're On expanded will to filing probably to or It you be work just on those want T. incorporate CAR the question regulatory able the that doing Europe? data Anupam's with with program, does FDA will

a us potentially assume how IND that on the of filing give can Thanks. we your sense an should product? in autologous Just sort CAR you then wondered that's also if for initially many T and of XXXX,

Dietmar Berger

year. being information. early-access some a With John. And our of set and Memorial totality being on and this on from didn't you're experience the mesothelioma to types obtain to our program, publication program. thanks, is regarding Sloan regulatory is actually, the early-access have regards data that also various the data, human last also a of publish From data to also, most the recent the totality first early-access information question early-access correct. but program, that of the really happened the includes of you several regards And trials, studies early-access leiomyosarcoma present different broader will efficacy So the to over and study the then including this also an obviously. - pivotal the With includes authorities, program, Kettering concept years, safety we

provide with case are same the more under at because cannot continued We study before. patients. recruitment obviously, has details data this the from ongoing presentation but study study, as are expecting these ASCO the I is point embargo, and the

Isaac Ciechanover

This is Isaac.

gets just John, at the diseases, that ensure wants to give Atara therapy access a one to is make So to we this who because EAP study some patients can't patient to every addition the site, it. life-threatening it color who, this you example, for

for relatively who out. short patients disease. some for example, so of progressing are are there do their And is who in The these timing patients, fall

of totality so is both of information look agencies that at. And important will that our data and be part the

Dietmar Berger

related question the initially final program autologous objective our your platform. onto an mesothelin, this And with regarding this is allogeneic with yes,

Isaac Ciechanover

then with then versions what we can for similar where then similar XXX the next-generation get move we rapidly very allo very alter our to to it's PD-X program program very did XXX. knockout, to of proof-of-concept we So XXX and move forward it, with how into this XXX did making we

John Newman

you. Thank Okay, great.

Operator

the from question another line of have Salim We Mizuho. Syed of

Your open. line is

Salim Syed

all appreciate Hey, guys. color. really the Thanks for I it.

on me, couple a MS. for Just one

the becomes year the know this study thinking Given Phase in guess, delay the this that, I success the in here? about given more how X the a guys for should being be PTLD, catalyst the of we past program. important high-risk, as I described you high-reward now

should how just PTLD. And So investors it? What define get question, successful of on outcome on interpret the any as when commercial opportunity color do data a second then the the here? you we

in the enrollment Given the how are PTLD? is read delay there trial, in thinking opportunity Thank about guys clinical across commercial you you. the any in

Dietmar Berger

All right. Thank you, Salim.

again, MS track. on the once is study, MS program the Regarding

the during allogeneic study. presenting year-end and the safety This safety are We is dose-escalation a data X additional year. the at efficacy is Phase and data program. safety data a of initial the study This

basically time that study at had set it's We neuro setting. the planning dose-escalation And those be will looking disease, inflammatory data types can to yes, the including including be, then at endpoints an imaging, immunotherapy right? score, interested will year. but initial present and are provide this And the EDSS with first obviously patients T-cell because outcomes. brain we other in during We about allogeneic year, including a the is to we're biomarkers, positive this different in a this endpoints the we're later safe. We're and very of during later these excited other

Isaac Ciechanover

for a just market in patients. trial and through market, important Salim, the PTLD think we to from And the to our us regards read the for is very

intent, that has a proposition both therapy by physicians cost-effective read and and a has and patients. curative is through a value have strong We great

is from we think regards such, don't Phase What an as is using X we And I patients as see of for our this to at how is In is said, Phase studies their and All experience addition, smaller. the well the not number as in the unfortunate Dietmar to as where get in disease that as the you have to for that and it. gives that we of associated data market, therapy the the both as the and ultimate PTLD, site EAP, ultrarare us disease, to the these see that studies of this look don't surrogate for mentioned, demand of the as X lot of qualify SPUs regards state occur well previous that outcome patients a we'll comfort MSK in just therapy. trial. the isn't patients that send the with our

Utpal Koppikar

we've immunosuppression and - of to variation age standard There's of in as variation what believe factors, add in right? several there of incident I versus transplant just So it's well. I And on organ are center, Utpal. transplant the to the PTLD want degree ATT call of the type experience of earlier this the to The Isaac care versus patients. SOT. level of a the and type, wide adult pediatric at matters said. where this alluded EBV+ the seen rates. Dietmar

to the want of single-digit out we've that and across incident low all the the factors. patients that we've seen in what in than is SOT ATT, PTLD. It's seen do we more these along rates tapped It's moving net positive blended is is PTLD, with what NPC And or representing from out beyond So range. pipeline for EBV EAP product opportunity. just disease you

Salim Syed

Great, thanks guys. so much

Operator

the line William of from Matt of Blair. question Phipps Another

open. is line Your

Matt Phipps

question. my taking for Thanks morning. Good

is term one on would in faster I filing I track rate guess of can with dataset. that initial if half, a in say out that is and But by in as FDA define you So that discussions can not to is assume filing? for first lead mean EMA EMA mean, this a concluding you patients? the used result, complete you you're guys start, the XX year, by response approval once going X the the Phase still question you what the interested regulatory I all of from so more my pushing are for maybe the initial kind conjunction

Dietmar Berger

you, Matt. Thank

Let questions at time. me a take your one

with have this the they're progressing These partially update current want those out a I by data. because This time by that we're range we of submission, the authorities, to those exactly that half We the in purposefully, currently enrollment be some cannot in discussions ongoing, regulatory had the is will here submission there discussions. on and of that the trend. discussions are we in European point call of we're first it's totality we line discussions are Then on wide encouraged this I overall at progress the announced the package, and So point strategy based phase. regarding the of but still provided think about We well. of and would year, end discussion. the regulatory time

submit is in Europe. specific trend that these have latest on window Europe align is sources by is authorization is now this realized authorities have The global importantly, the that right? that's discussions both really enrollment and of specific align states that already again objective The the right, more based filing on in the on the precludes global in Europe, tab-cel totality different November, data that similar US conditional year exist where windows plan EU of this We we and submission development development on the discussions range regulatory and window. in filing to have. data accepting plan all including for we But latest the based a to EU they plan marketing you ongoing wide submission recently the the very with current a

update then the of hope half result more finalize year. discussions, timing regulatory by give really US and the our we the an potential these submission a first of the of end of As of to you to

to range ongoing, submission of are discussion outcomes. anticipate order still a this possible as frame time we provided discussions regulatory However, in wide these

Isaac Ciechanover

only would I this net give provided The range in out. to as to in the where discussions FDA us wide we is, Dietmar add, thing will order flexibility said, Matt, regards

wouldn't already make a not where this alluding conclusion supportive. they're I So in question your is FDA to that commentary

that be just are can't In that's and very with it. able in they've we around we we comfortable us, we'll supportive at those in commentary discussions tell point, been feel It's and fact, this that why make to you 'XX.

Dietmar Berger

and supported on it on actually And have FDA to and agencies those discussions open the the prime, really throughout breakthrough, progress, encouraged you're to right, both having is discussions. Yeah. the these ongoing actually, with EMA and they're

regarding initial Phase you patients is right, the have, to X of regulatory on a that in subsets, the of on and pivotal allows based submit at this that study. concept results, the based which number look for of our the experience means you strategy of you the overall really Regarding subset data, totality data

regulatory these As speak that but of preplanned the can't ongoing, results analysis. about is, see what discussions will exactly are that subset we that exactly initial are we subset

Matt Phipps

then And MSK would shared and you. initially starting Or mesothelioma tumors? you go know Thank own pleural you move and regarding okay. kind for next-gen local version, some look the think breast delivery forward When the mean at with believe, CAR, year was start you I very do mesothelin regional try to next to obviously I cavity? your other with it, also, triple-negative of Got the at mesothelin-positive you'll well. right to cancer they're as the IV include that encouraging. data guys I you

Dietmar Berger

are and discussion. the intriguing, obviously, have still are space. is We administration want data from and they into MSK strategy on I this intrapleural a based local clinical our say to finalized under the regional not

for intrapleural region obviously this of the IV types is subset of activating definitely a the with of will domain rising. preclinical high data that, are look thinking data cancer, And active mesothelin-positive right, a study. PDX tumors ovarian this where encouraging. is variety the that area The we're for product one really Besides mesothelin-positive, through tumor the to intravenously at application we're the but tumors, preclinical So product local a cancer an the that have well. we as to also breast but tumors? you we you of is Also, those types cancer also that That's XXX and seen other you're be domain can diseases. study unmet application, breast how application pancreatic need, And will there medical tumors look beyond of negative receptor. other then thinking next-generation if the been applied of of go other an types cancer, there's

have development overall. don't we the plan to think about So carefully

Isaac Ciechanover

in Yeah. as And I current the our only even you thing expectations. would add, this commentary, Matt, other exceeded program is can own imagine,

this the mesothelioma the safety say, we assume center is of is, take to of that in should be therapy. the going you So this is The patients that where bulk data this is is as intriguing. with this data Efficacy we data and in important program at the really that an have part interest publication only going demand the differentiates other in why molecule. update increased and AACR, we're June And ASCO. has in to which

say primary be that but would and be the will we're program mesothelioma as I So site, absolutely and core broader interested other where this indication initially in the developed. should intrapleural administration still

Matt Phipps

I answering Okay, question. makes. Thanks that my think for

Operator

question We Goldman of line from of another Salveen Richter have Sachs. the

open. line Your is

Maryana Breitman

Hi, a thank the is questions. I It couple. have taking for Breitman Salveen. Maryana for you

incident versus Like that the mentioned to - the how clarity rates the [indiscernible] how that rates especially in get depletion wondering them a product about was more and could different little a product like be that? also as has of calls. should US, have Thank US of is West how sort One and versus - wide you. regards Coast if sort product of evolves PTLD, variation of in calls thinking we Europe we in you these incident MSK calls, I

Dietmar Berger

they important. what only together you're speaking the here of because eventually, that talking important, But treatment programs with and broader We - site-specific specific And different obviously we're the When treatment impacts a that at those for even as - describes of paper in out other on the immunosuppressive they're the and In setting about T-cell really a an [indiscernible] lymphoproliferative sites really you towards some fact that question transplant it's but lot [indiscernible] recent see the sells regimens. is afterwards. sites treatment as the think that I'm Thank PTLD find of in overall, use in regiments talk side, the T-cell that That's for other of answering example, There's conclusions. all play in EBV of as not that it with a PTLD. median decrease. individual do to depletion, other global become in versus actually do way disease. factors detail care of we're single-digit basically more across and sites, rituximab and sites site-specific and about range about, of decision these of But really Europe sectors the low transplant you around level the be site, variation like do becomes is go US, variation. with come find PTLD, incidence we in Yeah. and also answer talking intensive you immunosuppression at sometimes cyclophosphamides the as increase the - standard exceeding US a post-transplant at the that sites well Europe directly we associated sites, really also exact the aggressive mix between single-digit work actually prevention and those the low we their then paradigm at lot learning about you way, this factors. you Eventually, This about each and the a needs the we the the taken other And see less prevention is the not our effect is variation. Stanford immunosuppression all center. are type of into stable. goes also transplant the that role. it's of in a of into we're the I sites. the variation and of these of quite biology across of The a with question. to T-cell, saying the of that any between provided And the incidents US, It's more coming because see monitoring Europe the activities medium account. site. positive all as and overall, as these are key transplant one or that along what immunosuppressive where be oriented has to types And factors in

Maryana Breitman

it, I next-generation T. on and prior were was fairly believe the mesothelin Got National at I had where the another Institute, question trials Cancer low. T used rate response There were CAR CAR

not gotten NCI. I presence rates wondering done response think the explain in they checkpoint were in immunosuppressive difference of that the has do inhibitors. you I'm how MSK versus

Dietmar Berger

different therapeutics. the studies Thank you we're at for were obviously looking They that question. mesothelin-targeted

that the has And very is mesothelin-targeting domain, a the I know think checkpoint scFv of has the we alone a specific than these obviously intrapleural has a been rate. this there the study been intrapleurally. you The in are that right? This carefully earlier check selected. response that itself. have obviously, licensed inhibitor the and the administration cells it will administration, key various eventually role, that. factors what here this other key give here, and we're characteristic administration? what have right? the checkpoint seen the One is versus achieve been inhibitor different the different scFv I is definitely trials. I is binding is - then a think and product, different scFv does you point when a of and doses And gives and component, on really time, talking demonstrating; studies rates the about don't intrapleural There is at response scFv. think of in MSK the is, play are binding that specific in that the addition we tumor the inhibitor And but cell one may factor high direct basically different IV we'll size much that's higher

maintaining not activity a checkpoint about alone. inhibitor inhibitor effect of together cells We're cells. checkpoint an effect of you're we're talking an about with really So talking of the because the

You're to [ph]. the persistence adding

with unleashing You're inhibitor. a T-cell component checkpoint the eventually

counts are is So there encouraging. of me that follow different. has that on the really various seen that. clinical obviously through will are and the this Eventually, what those very And patients, efficacy in is factors been for observations we

Isaac Ciechanover

I we The add the data, still observation. a know it's subset last thing comment of that this of would but inhibition does only where PD-X the baseline to is in small

And even where added was patients to had having administered. we're clear. or We've so response seeing single is combination that the fact is rates PD-X MSK - the before we experienced also the

also PD-X two the in really the knockout programs. a and of - in addition think product factor synergy the so ultimately what this differentiating I is next our prior is of from generation, And the

key point talk all achieve is product other as Those studies well issue [ph] about the key other safety in is studies efficacy itself was of to response really as tolerated. earlier able this. even we're the but The we also because rate, of

so long program Because of to to from order response. give period over these a this this I in is time. things patients - doses that's actually the of conditions, And durable the multiple necessary one by we're get that and really in intrigued the think ability administer to

Maryana Breitman

much. Got you very Thank so it that's useful.

Operator

Company. Frahm question another the have Cowen from line of and We of Marc

open. is line Your

Marc Frahm

sites. exactly Can on more on where then you opening are you maybe you And guys mentioned enrollment? metrics provide some

next maybe clinically, So to right where the What's you it XX? number be? right number of like the months? the would XX? sites six Is over Is

Dietmar Berger

taking for thanks so Hey, my questions.

of study. and And enrollment population the on ongoing the patient before. that open-label that comment done haven't cannot we effect X in Phase we is So

XX. sites, For at now we're the number additional of a

geographic adding then changing, And US. way, for really overall looking have that of add And about that sites, also the sites. that is beyond realize factor think really right? more will of currently adding example, the We're sites that not and process more you recruit more is the slow. spoken We sites, expand will in footprint we we're by we expeditiously. to Europe, Obviously, enrollment at. And we another us that be the number allows the number key

Isaac Ciechanover

study. we're Now into also this far along

as European accept date November, So the they're last had simply submission. to that's submission of mentioned, date a that cutoff a because willing we

planned sites, all these additional for so And with are us. the

numbers. the increasing obviously We are

far I four outreach, along. the to the developed It's advocacy, they other that additions, patients trying site of study first a when besides we're think first identify PTLD. So aspects the like - lot

when try backlog create really window relatively because time it's - earlier short. to is ultimately, a therapy. That to we on a give So

approach we've ensure the part really to may what to that become preannounced, and for of studies in taken this sort a or of we're eligible able identify a timely complete really that are key study that to them doing And the so really early a patients proactive program. surveillance manner. is And we're active EAP

Marc Frahm

the MS to in remind kind great. kind then you're XXX data can you Okay, in second XXX? what also first get How half program, dose-escalation then we've scheme data. updates efficacy see but the and to turning seen just when at that compare this the when EAM, start of does using these And we we of before to with

Dietmar Berger

right, about go thanks if perspective, on also this specific But data at together question. the data study, We're then currently Obviously, We you will published Michael patient, to but XXX dose final Pender, that's we from generated for with an you just be think dose-escalation per autologous initially - abstract. general We're what right? at Those - of and that currently T EAN program. a in allogeneic with have in the program. our dose-escalation, a were cells phase. started details the

progressive dose a to programs. you turned and that covering and data this the range [indiscernible]. then important on Expansion really see what at of at safety beyond. how doses, see And at but And we're you dose, will it's the You EAN, you escalate out. then data will in is that's even of obviously, all a that lower you will potentially EAN. and start What's dose see with basically

Marc Frahm

Okay, thank you.

Operator

another Raycroft from have the We Maury line Jefferies. of of question

Your line is open.

Maury Raycroft

Hi, everyone. for Good taking morning. Thanks my questions.

to one the there soon just than weighted enough wondering if patients on is to number and on of more whether provide patients lower getting out First it's I'm give it's the treatment. toward expected just EBV+ you can whether the more not them PTLD color tab-cel trial. that's or

Dietmar Berger

is MBR, patient Thanks talking a then eventually, trial usually homogeneous for to try And always where an It's you population. Now ultrarare a disease. to we're an a the both, have mixture question. PTLD right? about here of pivotal

is survival deliver have the of refractory right? the is that makes have trial the We So right? treatment. patient additional XX think right? is learned have very, that to patients after means a to provide to the to challenging us. HCT time smaller. treatment is site, you patient this allogeneic identify an What Once even an really The of so sense rapidly, why in rapid have the makes this for XX you we've come don't time product for and to number these coming patients. median also also you which very able be is what identified trial, that especially other for days, to patients about They are site open progression, to don't patients transfer relapse quickly. because the to much need patients open. for to need the you You site out, setting right? Physicians another to Or Eventually, need the

study, those overall, all value have we for that I within see to for you access as that that be do. program, want an the five is say, for we explores really trial, fact Of can products, that that you're And early with to proposition we tab-cel, we and the to so the fact want With the absolutely planning NPC days to course, the that the there. allogeneic product as value tab-cel. three fact market opportunity to able have to and deliver refreshed

Maury Raycroft

can that, wondering then And it, you're noticing if that differences helpful. HCT that's follow-up comment I'm Got on? just SOT a as very any you to and between

Dietmar Berger

solid Also if solid the got more transplant this Obviously, and the it's means and delay PTLD. years the have very organ you study. of there's years the with the on basically setting, look to transplant also epidemiology, organ in more in there's cases, differences type, you've a because immunosuppression. organ dependent real opportunity at No occurs which PTLD

solid it As we the What transplant at different you the you approach, for example, follow-up of include you those do of can us, either are sites the patients see do see referral get the transplant. it settings that And very or How community you them? over PTLD where That's treated arena, that's So at to? community where key can the right? center this part need sites in the organ of like to transplant can right, to long-term you in then their centers, we course you this why right? are can even learning center? another for go How treat PTLD. see

I point slight different HCT between in SOT. key lot the to out different are similar is And So with areas, response a these biology tab-cel that in is differences PTLD associated prolific of Eventually, same those is and of the also PTLD right? to there's learnings. the want PTLD, and there is more immunosuppression areas. very disease The [ph]

Maury Raycroft

it, question is administering you if And that. wondering in big you if on cells administered intrapleurally you the mesothelin of thank I'm and trapped the you're a last having could the and with comment Got efficacy. that that if is such and seeing on guys Pretty administration, route are program. or if the intrapleurally, that that's there's understanding, a nice making being interesting difference therapy area

Dietmar Berger

have specific the [ph] versus checkpoint positive obviously, But and with to could because use nobody inhibition the answer additional has with of right, Eventually, comparison. product studied with they IV, really this you to scFv. the specific the to and these very that that ever administration, know, the has come intrapleural don't be a we so data with wide intrapleural the we specific

go So will and the design program we how second generation product. will we this all our on this, development up for into follow

Maury Raycroft

do delivery, of whether you're it, have persistence better-than-expected Got you a getting guess? intrapleural I based on sense

Dietmar Berger

Yeah.

already cells facilities that time. circulation at for the extended investigator, he of an demonstrating see AACR, right, presumably the does T the of and in Some were the data was period [ph], mesothelin-targeting CAR

was, time, than see at that better he interpreting ASCO We'll expected that point in at with facilities. that as well. potentially as So updates

Maury Raycroft

Great, thank very you much.

Operator

will This call closing Dr. concludes back over for session. now And to question-and-answer Isaac our I remarks. the turn Ciechanover

Isaac Ciechanover

that Thank on And point. is when to many great many the have milestones taking achieve the transform call Thank to thank extraordinary ahead. named, position to realize you. diseases. team enabled a to today. all. contributions mission I utmost he the I everyone also us want acknowledge time CEO lives you be the new to serious for wish important in patients of our to a reach employees Atara's by with the she this to or I in confidence Atara us will further join

Operator

conference This call. concludes today's

You may now all disconnect.

Atara Biotherapeutics (ATRA) 12 May 192019 Q1 Earnings call transcript