ATRA - Earnings call transcript Q2 2022 | Atara Biotherapeutics, Inc.

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Operator

Greetings, and welcome to Atara Biotherapeutics Q2 2022 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Mr. Eric Hyllengren, Vice President, Investor Relations and Finance. Thank you, sir.

begin. may You

Eric Hyllengren

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

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

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

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

Pascal Touchon

expected annual continuation of activities to reduction runway a are burn XX% staff year. cash time, extend reduction at innovative while leaner and same you, while our includes of reducing planned actions to optimizes the It lead the in this across our still is for the opportunities suited our plans the of improving joining well XXXX further and This funding, and and afternoon. a clinical These into company shareholders. impact strategy Atara announced the approximately Fabre. us three and clinical We the and these advance XX% on partnership actions of in partnerships a Fujifilm product over Today, research all are to need the build QX assets. the company's organization of to includes last candidates announced you CAR strategic and designed deliver for to filing pipeline advance for expected including durable future cash great for address meaningful part on T, to organization on and Thank opportunity could focus we cash strategy. a focus versus burn. for Pierre it future in position by resources announced Biotechnologies cash Diosynth of development-centered malignancies. our Eric, XX These second, thank key anticipated to hard ATAXXXX, T-cell believe treated, prioritize is advanced the have strategic Phase clinical best-in-class for of ATAXXX while Atara prioritization of seeking and and on activities manufacturing development patients are the patients partner therapy organization regulatory finally, of activities priorities: next our this than first, for multiple more further field most XXX will potential The allogeneic in three response the We differentiated tab-cel over previously strategy transformative progressive value on current U.S., in actions all assets pipeline on QX XXXX for extend company significant development our treat for allogeneic which and could significant creation, research in tab-cel, approval ATAXXX which strategic milestones and with nondilutive experience collaboration new terms we in sclerosis; delivering potential could and filings potential platform development this and and months a asset today and commercial related core the B-cell EU potentially for this CDXX clinical IND unique for R&D believe X commercialization costs, and or a ATAXXXX. Leveraging value with U.S. a tab-cel today. a as runway;

progress detail me key our Let plans priorities. for now strategic and

EMBOLD are adjustment we the own internal announced or recommendation following have and analysis IDSMC at of approximately in the endpoint confirmed the importantly, months, of enrollment we ATAXXX on in disability XX made included the be Based at the planned July, endpoint. completed be the will X end a July, assessment, modification determined EDSS no the to the sample we As interim by study FDA size improvement primary as primary study, of patients study. to of Phase our and XX, recommended that X-X, which readout

October XXXX. of communicate expect final in readout We this to data

study with recent finding can cell on are brain confident EBV-infected a debilitating this differentiating disease. pathology for for the by well-supported in EMBOLD of inflammation reactive plasma present to treatment These generation drive ATAXXX clinical the a antibodies cells We autoreactive now against publication deliver Indeed, patients. brain CNS and EBV-infected chronic transformative in is the in stimulating hypothesis made possibility MS EBV-infected and showed progress by targeting the autoreactive proteins. are how into B-cells T-cells B therapeutic B the some the MS to drive in Natures The improvement cells. and pleased significant in non-active towards

targeting B We the of plasma core and EBV-infected disease are the cells. about address excited therefore ATAXXX potential cells in to its at this

approach our and addition data our our in robust pursuing reinforced shown leadership in and is open-label by Phase the rationale, this EBV-targeted so study X scientific clinical far. encouraging confidence In extension to

of EDSS the time QX months. plan that either XX the this improvement study, FDA conference of in reminder, data we out and patients. XX-month stability confirmed for ATAXXX patients a the on XX% for their Fast two extension XX appropriate in study In of MRI present endpoint providing the open-label designations. or of to OAD from for open continue to impact potential the we an had X cohorts As primary a the have evidence including of MS achieved patients label EDSS further our observation showed and extension new based in progressive or data X Phase at point, Also, with plan EMBOLD. updated ATAXXX the X registration FDA EDSS clinical X readiness Phase Phase Phase its improvement study Furthermore, XX at and XX year, of confirmed the up to interacting the Track

which our like biologic manufacturing manufactured. and to process develop of enable proprietary Importantly, bioreactor we we're expect also continuing up to further cost goods scale

Finally, potential biopharma we exploring potential will ATAXXX. maximize partnering could value continue creation opportunities to with that the of be opportunistic in companies

Following of have in a the interest generating future on the significant focus discussion companies with potential number a EMBOLD a and partnership confirmed further have in keen we value. to IA, plan

trial. create need update path Another including priority with starting for clinical regulatory on potential is a key on a the progress front. without would our the leadership, tab-cel strategic I BLA Indeed, tab-cel. to with to agency recommended U.S. FDA, to submission give the the following discussion new recent value senior an like now constructive

can quarterly very the that with PTLD options on we pleased scheduled and prognosis options. BLA call. become are interactions further tab-cel FDA, potentially guidance EBV-positive give or and will our earnings no additional with to We with poor approved submission We those following believe in patients this life-saving next progress upcoming outcome at treatment need

decision an [technical supported high treated need important population. which ASH. interest We diagnosis-related. patient belief strong already also believe tab-cel cell a advisory and in has tab-cel knew the institutions had the data recently, and More rule for therapeutic for payer been as proposition upon can payer to XXXX value assign improvement system. the previously care and U.S. shown tab-cel IPPS payers EBV-positive that to by us payers in in DRG its proposition presented clinical market recently tab-cel released see physicians boards year difficulty] have formally PTLD newly We XX, deliver is our at that tab-cel sales compelling the last health value treating Atara's CMS research clearly based

Operator

Ladies we technical resume The apologize please The stand will difficulties. by. for and do Again, event momentarily. momentarily. resume gentlemen, our event will

Pascal Touchon

call technical like the this starting all just at difficulty. We'd tab-cel. for to resume Sorry and

another regulatory front. U.S. an tab-cel. I tab-cel to would priority give on key on strategic with progress like update now said, to the create recent I value starting As with our

Following without with submission senior agency the the constructive need for discussions trial. BLA including clinical recommended FDA, leadership, a to path new a potential

uphold patients the with our a treatment next those further with very potentially upcoming earnings EBV+ And submission better can interactions will progress no give tab-cel life-saving that to at call. guidance this and following FDA, a We need prognosis poor PTLD scheduled pleased We believe we become for in options. are with outcome. options additional on

extremely BLA Obtaining approved, diagnosis-related patients EBV+ treated U.S. filing is its for belief therapeutic formally CAR IPPS the We We on value been with reimbursement also by market the upon important the group shown improve based physicians to a improvement our as such need DRG-XX, in advisory for a this see data for treating for ASH. patients have research team patient payer assign recently to payers Once by XXXX and payer compelling PTLD potentially tab-cel knew More rare already PTLD. supported this will the believe year that payers based health tab-cel has is Atara's presented developed released proposition in tab-cel system. tab-cel an can inks a arguments tab-cel sales advance us for board rule life-saving strong at value to care is have access assignment value that our decision proposition, population. T. EBV+ of compelling and CMS clinical deliver institutions recently, newly interest need. in which therapy in such clearly and high in that and previously is top

decided from for use said expanding tab-cel have addressable this multi-cord and will potential million launch want an PTLD of at system, sales top attend for that invest with could who devoted tab-cel in merchandising U.S. who with in a coming establish on on upsell has appropriately believe team have At and we EBV+ approved we foundation tab-cel we that value in pricing and EBV+ label commercialization health to benefit the opportunity tremendous expansion in solid tab-cel realize to term in future. deliver As hundred our near in order considering from to significant When U.S. while seek market the we approved. cell effort PTLD that over focus study. believe in field patients ultrarare thank Atara in from patients the the opportunities, first the that activities previous the for the label into could $XXX the getting care this partner once a such several Atara stage, attractive therapy. To I value indication line to sales have therapy we before, is following peak the the or the potential of -

We passed We authorization Moving track UN anticipate the on is to all of pre-approval approval following Medicine excellent to application answers of Europe. in on European or review GMP inspection marketing and Europe. to in for tab-cel tab-cel Agency QX submission the EMA all is day compliance for questions. progress This XXXX. support Commission our required XXX

tab-cel in thereby I'm commercial bringing Fabre, have at with along are for product for the launch patients Pierre one inventory. Fabre actively very commercial and we, value already partner, year shareholders. Europe, market, partners than of that manufactured to Our more preparing and Pierre our generating we close is to the excited tab-cel

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

Jakob Dupont

Thank you, Pascal.

on mesothelin-directed update T-cell therapies. First, I an want our provide CAR to

rights study clinical And Cancer the currently supportive differentiated terminated an a allogeneic Kettering have Bayer, Center, study. T a fatal licensing for Phase The an owned continue our by therapies, Memorial and now mesothelin dose I'd the product mesothelin-directed immunotherapy. autologous serious patient by with developed by next-generation version; these partner, ATAXXXX, and to ATAXXXX, are regarding T-cell to an Sloan in update is T-cell CAR innovative which that be conducted X we exclusive provide respect We of like adverse treated in to ATAXXXX, programs the event have recent MSK. escalation and being agreement With worldwide this wholly CAR armored returned been for Atara.

a us, specific autopsy-based Over analyses, they with the in The on on- received. with adverse from is that question off-target significant generated which the of event shared the death. independently we have T the T. MSK the associated CAR and MSK tissues complication months, us. with of has Based two correlative a This last established see no organ therapies AE has data rare in cause the shared toxicities but this data autopsy recognized several or of non-CAR end that patient as evidence

associated assessment be FDA the We with an enrollment our their analyses shed unfortunate is resuming on through protocol light appreciate along of We communicating is CAR performed T such, help with for ill intend their assessments case We amendment our that MSK patient the to with policies. study the event. to As to collaboration will via of detailed this by patient. very continue support development MSK appreciate not the adverse the correlative directly XXXX and unfortunate resumed. the to these MSK once per complex plan

allogeneic to this funding quarter we pause provide decided Meanwhile, is development Phase program, a filing update to until and activities IND This have our as expect the towards was of Phase Additionally, fourth starting ATAXXXX data CAR the mesothelin-targeted X in to temporarily we ATAXXXX. for T for will additional the Bayer in fund year. the of the program, X. available planned occur pause IND clinical this

a However, medical We key they differentiated domain in has high programs. remains XXX tumors and the solid co-stimulatory believe and a receptor mesothelin need using negative unmet our strong PD-X-dominant several of and our technologies. CAR the design potential conviction behind next-generation CAR target T unique

to or does editing HLA require retains receptor. approach CAR T-cell Atara's Importantly, any endogenous the T and gene TCR not

and studies co-stimulatory format shown and academic durability non-gene-edited persistence, armoring been increase Our trafficking. approaches domain have in to

approach is we as a since over patients worth target space, to particularly allogeneic have, EBV differentiator our allogeneic believe utilizes this mentioned, experience. unique format having this an also in T-cells We this where of XXX clinical Pascal

process, of ATAXXXX Dr. track a for as are an advancing by enriched optimization part preclinical of overall advanced expressing allogeneic QX significant submit are Michel We're in using program domain CAR we T-cell optimized to continues this IND for on is best-in-class XXX it in in the an to approach year. is T studies. activity phenotype co-stimulatory as invented which Sadelain, malignancies especially address to manufacturing CDXX addition, from potential unmet In well memory B-cell as existing lymphoma. B-cell and show the a robust medical products this need This manufacturing to malignancies, ATAXXXX and of differentiate and

T-cells, to the accessibility. Some of safety response the of potential EBV durability persistence increase best-in-class the are efficacy, of points off-the-shelf CAR key differentiation potentially and

Before progress extend and studies. my back patients to far. to for I the am Atara the R&D our thus to like I Pascal, call turn staff, gratitude I'd the team has the collaborators our delivered our involved in thankful

T-cell Going very assets operations and allogeneic to collaborators forward, three forward have in technical will R&D focus potential. our need have constructively our therapies, research advancing an early a talented unwavering we work with key and teams and in Pascal? continue on curative our with academic bring team to programs bring to commitment who some patients

Pascal Touchon

Thanks, Jakob.

financials. our to on Now

collaboration anticipate of Bayer and quarters deferred consisting decrease to due future of agreements. the revenues that the license collaboration Bayer we revenue the recognized and For termination license license collaboration $XX.X revenue reported will the to in of second due of substantially the the agreements. We XXXX, primarily termination of -- quarter million,

position facility our fund planned million the and with approximately from of the We be quarter a of in This in ATOM cash. We facility of approximately gain for of gain also ended balance, second includes sale on second to runway, the during our a With expected quarter sufficient $XX.X the cash reported cash included into operating quarter the million. impact net regard to the quarter. $XX.X million This the million of second XXXX with the the quarter. of proceeds first believe we second amount XXX sale operations burn, of XXXX. cash reductions from will net benefit $XX together our the ATOM

to including is as departing medicines sincere I day while as a acknowledge to to staying in now for we my actions call also our have would Atarans. to in will to call. for I the will be of you Thank that done. over need. therapies, and their with gratitude in extend potentially those patient also advancing to Atara to the contribution we all want operator pipeline turn commitment patients announced I for lives the transform innovative you their position it staff, significant successful Q&A unwavering well for seek challenging our the all innovative Finally, I Operator? of like Atara the advancing that believe best the of for truly part today

Operator

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

your with question. proceed may You

Salim Syed

decision you to would on -- me, EDSS actually confirm continue Great. just X, comfortable factored the ever Could or there's ATAXXX. and that Phase Two, there comfort predictability guys question for Phase some sense last Good is the number? predictability us IA? the guys then Phase And actually you I data, did your us the And that if X, for number sort how One, we risen from guys you it you I perhaps that if you the if a that's if threshold. do was looking any that's Phase can, if data on use disclosed IA guys. could that's you yes, baseline us IA. the why Jakob, the saw of Three saw that no tell what the know Thank saw some this. you. lower think X? we there the because wasn't for was? XX% a the you XX% the use just baseline for know and did study, perhaps the in you don't there actually I be what we Or an confusion I EDSS for the were for the Pascal just at -- data give drop we great. questions. afternoon, but that X. in a because used and can Phase post Thanks -- threshold of just on for on what just X the in actually get creep in into creep were

Pascal Touchon

Thank Salim. you,

start then together answer Jakob, other first AJ with will answering two. I'll and the So the question

And been recommendation, IDSMC the the following Atara, detailed our myself, on So as few Jakob much decision the on have their has IDSMC recommendation. line within including as and seen AJ and that that people data. comment recommendation a based on top

seen the AJ, data. want line So the top you please? question, do we've to address second

AJ Joshi

the Sure. of it. Thanks, the there's in of probably to baseline the creep, X, two things one some comment it's Salim. EDSS terms this is that And EDSS I'd -- on there. One for -- has know variability Phase we I concept think

against So advantage once seen at would you creep a the all have up an some bit for That, little it consecutive maintain months. drop and random improvement, in you're kind a of time point on. every of later to general, it way then you've XX giving you baseline argue taking

the important we second EDSS correlates as that saw. just the though data thing improvement I is is MTR think that that with probably

think EDSS there's heard happening happen that whole some piece. they whatever about ,there's may support patients something those may there's you from happened, to have you might to believe creep think So that that's or Pascal that on in if let's the that's improvement. to continue decrease different then that going other talking something data MTR we happens. MRI no measurement that we're not measurement notion say, you've But going And the happen, be also when which don't have

really commented articulated specific issue apart productivity, any -- that, terms the really rationale about IA you thresholds related any really So reasons that in on the used IA. an but the haven't are to all haven't thresholds And of think XX% we specific here. on we from the were those for that that not that's to commented

Salim Syed

Super helpful. Thank much. it. you so Got

Operator

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

with proceed may question. your You

Tessa Romero

for guys. so taking question. Hi, our you Thank much

on side. is cash the The first one

about you 'XX. and XQ runway $XXX cash to XQ guiding to million in ended with you So a are

your any So that in to can tab-cel, then levers that milestones one runway, more what pull are detail And terms what expected extend And of further provide the that runway you partnerships? assumptions you're I could including on if have could. are Atara some I that if on further to from receive necessary? in

Pascal Touchon

you do Utpal, question, this? want address to First

Utpal Koppikar

Thanks for Sure. Tessa, the Utpal. it's question.

XX% year. that one think I mentioned things Pascal incurred what is reduction. versus last we reduction the of key mentioned had burn We

Now to going time some it's take something occur. that's to

go as activities has decrease. burn Europe, approval forward can with the down. continue reduction burn happened get we Pierre the staff, the up will the reduce into Some in FDB with you to filing as all Fabre XXXX And wrap deal. we and when to we will And continue burn look

have the to first keep in that's key mind. So you thing

in to but related continuing for second extend at us. the tab-cel little that to asked we you that about look runway, we more nondilutive opportunity how thing The talk particularly terms do can could we're other some a to of U.S. an about, bit cash further financing is and opportunities European

Tessa Romero

there any reflecting? that should And Okay. milestones we be

Utpal Koppikar

commented Yes. There have we Europe, associated Fabre not but with are Pierre in them. on milestones

Tessa Romero

Okay. one from And me more tab-cel. on then

you you any you're has in or considering path we FDA? that so detail can be BLA on recommended here a provide the with that a scenarios Thank discussing submission for FDA much. Just by should the to that the U.S. been the possible more

Pascal Touchon

address Yes. Jakob, want one? that to you

Jakob Dupont

Absolutely.

thanks Tessa, for the So question.

trials. So we've need they path FDA, BLA do, as a with prepared constructive to you comments, recommend as had possible Pascal for comment mentioned -- new to the discussions without clinical in and allude the our submission

from commercial currently may is consistent we leveraging patients recommendation. adjustment treated that our recall an So previous This made, from with proposal you product the quarterly path previous is the pivotal their in that study. with as call,

there's one potential and the content to to of on terms that's There's steps, more are of meetings BLA. align planned. one In the next follow scheduled

BLA towards at plan color path giving additional So our call. a we do quarterly next on this to potential

Tessa Romero

Okay. questions. much Thanks taking our for so

Pascal Touchon

Thank you, Tessa.

Operator

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

may You proceed with question. your

John Newman

Congrats question. with on FDA and the for guys. tab-cel. taking Hi, my progress Thanks the

on question Just had follow-up a tab-cel.

of to additional sales data, clinical we time. that into to requests those types without requesting ongoing type getting some able in our of satisfy what that be are FDA reasonable activities of a they Assuming the amount be believe

difficulty] example, for clinical for time. long patients curious, structure together in that more the clinical [technical like existing Just if Thank data to you. the pull looking agency a

Pascal Touchon

that to want you do Jakob, one? address

Jakob Dupont

Yes.

as to the I a possible think recommends So need without trial. path a think outcome that BLA I for new today, the is FDA we're significant reporting the clinical

So where now. is -- to But of data be in a we and one after meeting -- then again, clinical that mentioned be we're terms and that's what expectation involved are potential to will negotiations, content here And going I that. of filing. in that, that's it's But new coming another the scheduled follow speaking trial. that about from the not BLA

Pascal Touchon

are but I ALLELE studies study, as we also particular, in may the product, commercial in not treating with that the in in add, the pivotal Yes. a patients EAP only program. John, well other study, and

going we important to data, commercial is accumulating the submission. a really basically product So BLA the are all number efficacy be and of for safety clinical that using and

John Newman

that be of some CDXX-focused would population, study? about or therapies? the other on focusing question ATAXXXX. types Okay. might And allowing I'm potential one on hear the Actually on near there that clinical I exciting forward, really to an design additional a patient Great. think you there had therapies IND then CDXX filing think going do were naive, that here. term. think be that curious, question the patients population patient the on you you'll about just Or planning

Pascal Touchon

thank No, you.

about We is be or medical to to XX% today lymphoma in in the six remission our but therapy T and different response. to complete months. either other even at in of at the CR giving say most see of the are of autologous around details most first-in-human focus particular, rate CAR are will not type existing T see therapies, even look lymphoma, we up And though can we at clinical giving today study, focus important in medical beyond. not we really the being the will months And usually CAR -- development. by six need. fulfilled and it's One, durability have the that need of Our allogeneic be

compared in a and here is T of this safety a type with improved higher CAR of safety good percentage need patients there have So autologous to with regulation.

So that's clinical one need. of type

relapsing, The patients is, due to lack of that used need but say, of controlled of this persistence have know other or lead after type that durable doesn't type not CDXX not previous been Hence, a is target, the particular And therapy, being as you T therapy CAR other we clinical therapy. to are issue, of the the they're relapsing. with that often this remission. they only

there these plan development, clinical detail a So two our somehow that that address medical in of stage. to needs more about we are type at but later

John Newman

Okay. Great. Thank you.

Operator

Our next Co. Cowen Nadeau line with from question & the of comes Phil

You may proceed with your question.

Ernesto RodriguezDumont

I our Hi, Ernie for if question. thanks for Phil. questions, taking is Two may. This

first The just a ATAXXX. one, clarification on

But remarks interim it that the with initial your the that your decision after interpretation wondering made. internal was I if analysis? your prepared as decision. that sounds if is agree assumptions So I so, for assumptions I interim -- agreement understand going the based was that And Thanks. from on And correct? data into the now, your team, was executive team did assessment, analysis your see

Pascal Touchon

you Thank your question. for

charter their has data binding Then we the the access put changes including on then our can the do the sample top not initially IDSMC us follow interim aligned assessment, So from that that way to a after have we myself, indeed best data, based today create able and to led And line not we of side with we've top that fully just this and planned no had full data data that AJ they of myself few the seen. confirm to data. were value able that IDSMC Jakob and independently the be clarified to full line for the study data, in this to recommendations this is the see unblinded Jakob, the whether few top recommendation, view individuals us, in of the the to data and line the as the have recommendation data a the is to data confirm what by put we to informed analysis, of be asset.

Ernesto RodriguezDumont

-- Thanks. And on then sorry.

Pascal Touchon

No, please. go ahead,

Ernesto RodriguezDumont

an you how And on FDA proposed on tab-cel, that it? Thanks. -- BLA the do Do pathway have Okay. And they will was decision? in could have to long something partner do you the the feedback to decision the with also tab-cel, then filing? estimate delayed factor

Pascal Touchon

you of the the first question, take Jakob? to Do part want

Jakob Dupont

Yes.

So I there that. an meeting from be and scheduled the the -- that will steps have, are meeting next perspective then as another is clear we after that mentioned, upcoming

be the able future. So not-too-distant And quarterly these call. at to line content the in the submission BLA BLA time for will I next submission think our the and provide of we'll on detail the occur more

Pascal Touchon

decision second the your promising to in and I and realize a that for flexibility that U.S. commercial have sure ATAXXX, assets, ATAXXXX. position for value on milestones for catalysts tab-cel is well the really to key the And and will to greater partner us look most tab-cel, we fully question, financial think make advanced

So shareholders our milestones focus value allows European can value it's on priority partnering in we to the our product, creating demonstrated assets. care for have the And that us this possibility cost enabling related we really most allocation further where runway. potentially by that and all that taken launch strategy believe deal our resource the and to us extend think and could for -- the key with partnering significant very around partnering our finding and create activity for prepare we to -- cash that to catalysts create we reaching and around

Ernesto RodriguezDumont

question. helpful. taking again Thank my Very you Great. for

Operator

comes Our with Michael question the DiFiore ISI. Evercore line from of next

may with your proceed You question.

Michael DiFiore

for much tab-cel. my Hi question. Both for me. taking A guys. Thanks about few so

to to What by potential happen. that decision may this being with the willing for a they led does achieved not possibly You And the costs? forward how new referring are the runway your be sound FDA. partner keep point? commercial extend as now? what question in of desire recommended registration just discussed Are And it studies by comments, it implies patients to to on this a you. a on path on result cash there share much -- And not accept this at path my being to fueled part not was -- even it they expecting That agency as additional sounds opts from does the this? needs been it like this has runway. it could that well? is if Thank second into here? could post-marketing U.S. What Because like be a sound potential partnership. that Like access expanded this

Pascal Touchon

Yes.

address always talk me you about Let mean, both here. usual, questions on potential. -- the as I

We pre-BLA haven't had a meeting.

not have filed yet. the We BLA

we talk potential. why that's So always about

the to some again, we've moving recommendation last clearly Jakob We confirm over and a forward constructively planned timing. -- said, the we what the And few has to steps but and we said quarterly particular is interactions this the for previous exact based are on us at get of we what to before with we've propose them call. discussed as the our we and have to months fundamentally FDA that path submission, now a with them, can allows also BLA as have that's response to done work as achieve, what

major differences no is there there. So

At On sense is a in in where right the a further made to because, NPV have partnering, the of to share and are assets remains significant have can really look partnering to again, resource for clinical stage, we value-creating commercialization there investing commercialization. us about for makes stage, and when it company, create key with we for that our value at it's believe always allows aspect, we that's the done or that a this the it between shareholders. way, developing allocation we partnering that for in all decision second the be

it consider to have create a partnership think for significant that value our we makes that to but now activities, able to shareholders. and also, Atara focus right and sense will be our again, So to

Michael DiFiore

much. so Thanks

Operator

of Our comes line Salveen with from next Richter question the Goldman Sachs.

proceed may your with You question.

Tommie Reerink

Thank know you for the our to mesothelin Tommie This work cadence of how is taking wanted on R&D to updates question. going for for Salveen. I programs. the about is

discussions you. for and explain we behind And X now you XXXX XXXX? you the on you're in the planning their studies plan just have can more Phase So given after how is focusing advanced? out Thank timing XXXX the for prioritizing rationale more would for that that context update your XXXX,

Pascal Touchon

XXXX. to development about So part. just continue We plan still maybe of clarify that to

is to we because that expecting That's study FDA by we to what our the done the funding What pause support just supposed amendment -- was and study decided make and are has resume. going to for proposal are Bayer. to the As that. the first-in-human to have about we Jakob at XXXX IND clinical clinical study, for be the a MSK development do. explained, collaborators to And so now can protocol, the we some the

have Now have to assets we we the a able collaboration we we -- in considering certainly that to bring the need potential But come the appropriate to create to the bring further clinical certainly, are once to that different to program are these them, this belief We value. to fully plan just from situation really a program again, we we in would where versions. of And IND these that to have funding. It's sources. And we we XXXX start the the have -- are with terminated have XXXX. the be funding clinic strong and allogeneic development. owned

Jakob Dupont

maybe one point. other And just

an about with asked You mesothelin. update

Kettering. discussed as data XXXX our as to with updated well, partners we provide this on continue today see we autologous an as year program that to opportunity So on QX

Pascal Touchon

add of maybe also get level and And instead is about and giving terms benefit T-cell a truly XXXX leading then could has priority study. our why aspect first-in-human to rapidly platform mainly indeed is data potential XXXX in that safety. And further differentiated is potential that in Yes. of at believe question IND that confirmation to for some XXXX your the what to This to create best-in-class response same we allogeneic in to clinical to rate, patients. the the situation of efficacy time, because clarify

So concept. allogeneic in CDXX it's do the mesothelioma, ability plan we get responses this proper other at that an that clinical and speed data Again, developing of time. faster still going certain cancer is lung than terms said, to to getting to type into being to evaluate of T CAR

and ready all to believe to that forward value for we funding development It's has of we're So our allocation move asset, able to will and steps go clinical potential into that with matter the XXXX. strategy just company. resource now, patients find to this be final be which a but right really IND

Operator

Nochomovitz with Citi. question comes next Our the from of line Yigal

You with may your proceed question.

Carly Kenselaar

in Yigal. mesothelin what's Thanks on And your for taking follow targets Maybe version. T additional on maybe our Hi, you to guess, in the actively repartner Carly up this level to then programs of the are is allogeneic I CAR advance order questions. just more beyond for to looking generally, partnering interest the prior question. mesothelin?

Pascal Touchon

Yes.

So that a we rapidly develop platform extremely and on allogeneic allows T have versatile targets. is CAR us to different

IND-enabling to proper even And have stage, we could CAR though not Now this we allocation. develop resource to T, and T. additional CAR clinical for development have further additional at make we go to decided studies

We of and pursuing, And with the Centers our new type for Memorial new have an have Kettering, new with collaborators with Australia. modalities. CAR in and Sloan work by QIMR other Ts done at to early targets constructs, allows that pipeline way, that Cancer are we also design, on some allogeneic

early exciting stage. an really continuing that that's part at So we're the

we clinical human XXXX. Now tab-cel, stage, to and on focus have into level decided asset, the investing advanced IND-enabling resources most the of and investment. i.e., ATAXXX first And is at this our another in studies

of said, being tumors. certainly indications significant XXXX, partnering therapy in a will for potential we open because possibilities, could address one solid being this this new Now different to very be a number

development. clinic focus the as which funding we available other will to that, hopefully, more then main experience we for allogeneic soon, that's soon from autologous, a ways to the of a with some few or the coming study able will the can while So have XXXX, have be clinical go resuming We the to from this but the as data matter be think either we and are months. on partnering this fund

Carly Kenselaar

great. you. Thank Okay,

Operator

Ladies the reached conference. have conclude today's and we This end session. of today's question-and-answer gentlemen, does

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

Atara Biotherapeutics (ATRA) 8 Aug 222022 Q2 Earnings call transcript