Allogene Therapeutics (ALLO) 7 Nov 242024 Q3 Earnings call transcript

Hello. Thank you for standing by, and welcome to Allogene Therapeutics Third Quarter 2024 Conference Call. [Operator Instructions] Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer. Ms. ahead. go please Cassiano,

results and available the all issued market provides and and release operator, XXXX. quarter this press our This a have website. call. that release financial update business After closed webcast a the welcome you, third who of are to today's joined press for on Thank today, Allogene

to note Following under keep questions have historically, We recognize our prepared that to remarks, hour. endeavor we multifaceted, X will that but host this will call a Q&A session. we been

me forecast efficacy are are other Dr. David of success ongoing risks release safety presentations, the SEC product trials, Joining Officer; may will Chief Parker, on found President regulatory change. candidates, Dr. Development disclosure of we manufacturing timing be and making capabilities, are that President statements planned assumptions filings, and the clinical call, Jeff Medical be and These Chang, include Vice Chief certain Executive statements current description today documents. of today's statements. data market our A and Financial press Officer; financial to can and and in efforts, based information, future and and regarding of our development Zachary our These forward-looking Chief and expectations Roberts, and subject Research latest Officer.  During and Executive guidance, research commercial potential things. among forward-looking

forward-looking I'll disclaims statements to You are now over Allogene these call these place cautioned the David. and on to obligation reliance turn to not any undue update statements.

we at score the autoimmune predict a first be, transform quarter, new tumors heme In overall solid sites the set to tumor, and and ability as malignancy, in of integrated best cancer standard marks this who CAR-T excited on I might renal therapy Christine, trial in those to for treatment today. efficacy and become confirmed advance I ALLO-XXX and call Phase continue patients one, of achievements rate and could patient step showing upcoming cema-cel continue of share We With our cell to first-line disease. B-cell ALLO-XXX positioning high am as led a first-line patients and pretreated for designation high with redefine treatment. mission XX% heavily forward recent significant risk define pivotal XX% response trial patients. trial of you, carcinoma, expression TRAVERSE from to Phase include: the for both ALPHAX in to renal achieving unprecedented rate cell its our a third treatment RMAT into cell cema-cel trial is for those progress the outcomes.  Solid high response activate Pipeline. carcinoma. the through tumor patients the for CDXX than expression. as advanced which II breakthrough for CDXX XX% lymphoma. we our could This proportion the of represents groundbreaking the Thank to the majority promising relapse welcome FDA, milestones a on greater potentially as and large Today, This therapy focus the

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of call our I dive the latest the to discuss trial into Zach to to ALPHAX ALLO-XXX and data provide the like status from hand deeper a over Now program. would

Thank you, David.

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therapy academic be like an more proportion into are will product to on ours. it as centers emphasis broad community CAR-T activated, settings, the make meaningful allogeneic is will ensuring Although shift community-based inroads any believe early this can we If accessibility. essential sites

in on tumors. ALLO-XXX, become LD morning.  We first continue survival showcases I'd for anticipate to now I in product candidate of data potential carcinoma and for the advanced Phase therapy CAR-T we heavily RCC. end of selection are mid-XXXX, license attention primary in XXXX a responses biologics groundbreaking with Beyond pretreated your This turn for our the solid event-free to T to patients application found released share data the and excited submission to the data pivotal treatment a cell encouraging this underscores the AlloCAR to ALLO-XXX ALLO-XXX off-the-shelf we like XXXX. for data potential by or renal the

defined rate overall details. response metastatic CDXX target of as metastatic start level. XX% the cancer TPS, demonstrated patients have with response scores tumor this confirmed proportion A XX%.  Importantly, high with ALLO-XXX above above or a CDXX the and patients or TPS response I'll infusion kidney a in into or single XX% with rate rates. an of expression, first score, advanced with majority dive RCC best at Let's impressive

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data oral Kidney comment speed may have the at we presentation followed for this with an ALLO-XXX or ICS, The safety optimal November setting define Immunotherapy the dose accessible This efficacy presentation or for by stage Cancer, on be help was reflects promising the will on RCC. ALLO-XXX's Ib solid or metastatic featured typically the Meeting don't the in Both on for While SITC, Cancer be impact X, tumors. will FDA a of received with in website.  We evaluate November technology International continue designation presentations at Symposium, interactions, cohort. advanced will for in poster patients and trials, our CAR-T expansion the development II Society our Annual actively to X. Phase Phase the on for which

encouraged We new offer are ultimately, testament need a opportunity deeply by options and updates CAR further Allogene's We next into data to of advancing look ALLO-XXX Today's managing forward across hope to disease. cell the as for over programs. of of of these is Jeff. to and the providing their of the turn potential commitment to we to in development results call all move field the our I'll therapy. T now to stages the patients

you, Thank Zach.

And to We We to As that heme have has treat on and shown clinically noted trial, are specifically X only To CDXX in transformative. is in CAR-Ts in all the we the hockey with where malignancies. Allogene product solid be continue positioned to pivotal dual quarter, CAR-T tumors. CDXX how David's validated disease. shots goal in control has control these real an allogeneic autoimmune designed CAR-T allogeneic a the been control I CDXX potential the position. that potential CAR enviable used only analogy, last only transform

million, million Let second balance XXXX highlights.  Our investments, associated million, which end research includes as our in expense. XXXX equivalents which cash and of and turn expenses $X.X the continues $X.X QX me $XXX.X QX expenses compensation. and million to were $XX.X includes cash stock-based compensation in with million $XX.X cash, of stock-based financial half noncash General in were noncash to and of administrative into our extend development now of cash QX was expenses the runway XXXX.

or long-lived impairment in For expense. including $X.XX of was QX noncash million of XXXX, share. $XX.X stock-based compensation million $XX.X million our net $XX.X per asset noncash and expense loss

open approximately $XXX approximately For to XXXX, GAAP expenses full million. from includes questions. of expect for expense estimated year of cash $XXX burn continue impact a operating potential approximately This million.  We now be which call we $XX guidance stock-based compensation development We'll expect XXXX the excludes continue business to any activities. to million, noncash

Tyler of line the from comes Buren question Van first of Our Instructions] [Operator Cowen. TD

on the couple a all progress. have Congratulations you. I for

RCC in response the pretty course, XX% one late-line confirmed the rate impressive. is, The data, of these patients on first is just

can autoimmune for with be the into your done data FC data And insight we program. to is start and So autoimmune to and just why might confidence with potential XXX XXX expansion is be you when your be able read-throughs I in discuss agree impressive then not might approval? that lymphodepletion. the just specifically cohort reducing regarding us the the give or think the best read-through? you data second about of a pivotal you But safety XXX can removing in the the as

Dave Tyler, Thanks questions. this Chang. for is insightful very

to ongoing to of one the answer of status Zach you turn that let first terms in study, questions it The TRPR the over me had.

questions. Great David, thanks, Thanks, Tyler. and

XX. next expansion into year. many think So sort of that of that, we'll to we're which, approximately patients that patients information will we give into wait to one, for expect adequate enroll of this as ascertain to first come really response cohort? us to for of rate well aiming course, the number durability, some the as in So We do how have

to be able program a year. update next we expect give So to

effect ALLO-XXX. XXX, As Ib and we we continue in poster further.  And is Dagger be additional so will does program, second additional in a that question even encouraged that this having with we confidence that by expansion for have the And lymphodepletion illustrate quite not we some been include to that have patients in selected data treated, on the regimen more and the Phase of kind have fact, XXX the real. more

So been regimen. a lymphodepletion efficacy demonstrate we've with to already able substantially reduced

or XXX dealing haven't alone. intend to early we So phase while to XXX one test just We actually the on we eliminate exactly really then the have is of quickly comment to that chemotherapy key program. that that, that ability study.  And plan be lymphodepletion, pretty with high pressure carry We'll into confidence use reduce the don't the autoimmune the will the to of definitely of the in forward disclosed objectives And piece. setting. safety finally,

it's milieu advanced very data it substantially we autoimmune of, are with And existing So the patients activity. the activity, different know that, We CAR-T a that who's of CAR an from from is of secondly, very, pretty patients autoimmune of the disease. as the in that persistence fundamentally biomarker did. somebody from with malignancies bulky that say, T obvious namely and in many aplasia inflammatory functional duration duration the B-cell cell in know tumors is lower setting patients as than got XXX program the

So of through of lot required good manage have therapy will with infections, autoimmune how associated really diagnose be these. a that ALLO-XXX patient lower.  That experience we with think to that around said, the will the comparatively handle be an overall, the toxicity the we dealing management and we a have intensity on of built with details in ECHS,

therapy intensity will absolutely any tox be AID. that up. ready for one, does number Number that, think lower crop we in we So two,

just mean, the target and we I and or over I greatly years, me efficacy. well as influences the indications that add. population learned as have the let safety Tyler, burden patient tumor the think And burden

about event So something the different kidney autoimmune specific yes, think manage target my that are XXX can and adverse that because a that cancer the we have make lot the view we experience the burden disease. test. read-through from I a your versus program, the is clinically read-through between is is learned much there And advanced our in this question know course don't so autoimmune you to indication better. to to lot we developing of a into also XXX through

the JPMorgan. comes Brian question of of line Cheng next from Our

on better easy the X for confounding management is led give data is could Could ICHS doctors be any for on Brian. Sean today? This And the us it sense algorithm in that monitor of a ICHS to the potential Grade How through how reported you effects walk events those case, cases? to implemented? you there events? the you will that Were

XXX disease findings for disease, from never adverse in there is especially disclosed Yes. advanced experience, great mean patients with the in in all the we different simple the confounded those in Sean, event a my well and that Phase underlying thanks by adverse have we the that a as metastatic I lot questions. oncology, event. much doses and lymphodepletion times we use very I, It's of also as tested.

the you question. X I answer are Grade ask So Zach that events every to XXX, say the can especially simply second we see confounded. events in that the I And that of mentioned very the case adverse will

that detailed of that Yes. algorithms CRS materials we've early management Thanks, the is developed to upcoming IECHS, algorithm in ICANS. clear. and and developed in as for is It's SITC as so analogous, the days the pretty very far Sean the fact, David, in were and

a So it's process. sort X-step of

symptoms therapy And convinced You there very, rapid that response and you a carefully. an if process is that ongoing and first-line then then which therapy. first-line institute are if monitor clear, very the you diagnostic see signs inflammatory and quickly escalate criteria, on to lab very don't based values you you are

So flavor methodology IUCHS. this is tried this is that one a and a CAR-T-related managing and just slightly it's tox, different given for true

years, all events think as a better but recognized And as is making it.  And there's of more over of syndrome, should i.E.CHS, course a it now pretty spectrum is a in the implement. people different. nuanced little Sean, entity, lot publications study understanding would And being it fact, of on this easy be to add, fact, has implement based couple the bit I it pretty last these cytokine been hyperinflammatory and recognized is to So also when easier. that I easy management release in this And widely and the we've time understanding. clear it's needed entity, a in this the much better understand

next comes the of Our line question from Yee Michael of Jefferies.

I about in you One a getting second questions. about rate thinking maybe of but CAR-T lot for for seeing autoimmune. seeing screening to that as the focus How And the been back going? a out and just on dynamics big of point around T little comment of are things X execution cell is underway? had that. different are a see question was then cell actually, bit it's your of around talk and about T how terms We versus first-line engagers lot there positivity. just little given CAR-T Obviously, lymphoma study. battle are there And how now out the And Maybe we're engagers terms early, there companies. perspective that MRD has there. what pace of enrollment we're you're you in you your a comment know a bit seeing versus about what

to modality fantastic questions. from about Always to reverse I'm to going I'll nice order. different going that's AID get to back into, talk hear Mike, I'm the you. going and frontline the Zach ask and to the study.

experience people B-cell what autoimmune modality, the substantial T or drug-free to We different recognize the underlying sort to cell CAR-T. production. and or we is I view to really being respect mean, bring indications, think many manage mean targeted by in overreactive so-called and of about modality, over many T opportunities. we the I are different diseases interval patients.  When totally way. whether With to can about CAR these diseases way this so cells behind the is through disease-free I so look a that think that as realizing are there at drug depletion, autoimmune using I all mechanism stories. different successful within coexist. have autoimmune is even can autologous modalities think be as the modalities, that's last antibody is one disease and of that And looking a can years, one engager people caused the particular there exactly B there how you case. I development, at of which And if are the can X that history other multiple diseases X think to more are than that well

things even is want XXX CAR-T, And great who emphasize to disorders. which really that comes with the the different the that twist. the accelerating context, modalities our different. is way the CDXX built-in the thinks portion for to in everything there address opportunities, lymphodepleting team ALLO-XXX the CAR-T. of Obviously, So onetime the different from as of about And this a is T, the allogeneic that how I a convenience this program just But to opportunities sort the physicians focus development And and coming CAR-T in. with very mean, really also all done, are once being technology and really that's we managing address viewed this of the treatment.  I think is designed like I perceived on CAR off-the-shelf, of our one usually a the attractive those these factor is autoimmune is proposition Dagger are And our dual of program. head else, one are anything chemotherapy. is is lastly, challenges is

very the questions I matures, potential will And autoimmune patients and you of lot feel But on emerges, first the about benefits are the with bring excited the some asking, ALLO-XXX can question? we that disorders. a the to it data data key think our Zach, know as better. that we

question. for Thanks, Yes. the Mike,

roof. has in I prepared way standard in the say in the pointed been basis, especially to at are in So I what have activity enthusiasm things have press engagement unfolding extremely the we the of remarks which is been daily been sites we're the that of excited the sites, by on trial from sites can clinical I through the activate the these release, a that onboarded. onboard earliest to and really a the here sites. early our pace the as would able sort days of say predominantly the community and sites trial, out and

of in sites the don't more have some T experience. active some fact, of them, And CAR

bit a there handholding, nice there to that shortage extra getting right, even engagement prognostic more little patients out the they're no something requiring they're deriving what is is enthusiasm and a and already. because they're but benefit, access a of than absolutely So are negative, screening little MRD

launch to encouraging very the very, trial. very, So

progressing a team ready. I and taken I be the we the is activation to And that's where as mean, get that compared Zach are all approach lot mean, care I planned. the more lot out. say would Yes. requires are study certain hands-on is to more, site days, get of finding things that, that documents a There pre-COVID I very also have activation, effective. so recognize what handling said, to very done operations And and the which going reactive had as smoothly. site really very site clinical proud our they with of is, I'm

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

are Mark without Congrats did that a quarter. This Fc data XXXX? would FCA data lymphodepletion ends planned group Salveen. expansion on as Phase the CDXX. difference? the for speculate cohort for better discuss have looking the Ib confidence And on the than that path? what the the today. realize why are what performed the ALLO-XXX ones but It data there's that forward CDXX, quick you is bit that's to released group little also, small of that for I have the the give on X for can I that and Like here, was in regulatory seems you you you threshold can on

just small hear mean number. I a you. let to quickly great first question. respond the from Mark, me It's to

seeing But the that finding presentation. We interesting the SITC, with are FCA in seeing we fact is most probably responders FC. poster the the are responses from Fc and both our

coming program, second from want kind the I read CDXX. into need biology that. the foresee that's with lymphodepletion the in any think T would moving the underlying that from standard the CAR this differences of enhancement do forward too allogeneic to much for small And the we that not lymphodepletion. Zach, you're seeing, without a And with DAGA fluCy-based As numbers, intrinsic that's program you an And take question? really I

Yes.

durability. this mentioned I that and we're think, XX shooting then of for So regimen ago, at moment patients sort Phase waiting Ib as a I for

the options if So think, we I numerically better are third-line this in I now just confirmed we, numerically you that at right response are think currently than from context. a rate, where sit look approved

So we're that. with pretty happy

question, Of treated We've responses. the need course, I durability. it's to Phase bit little nice more just regimen. ongoing the got several on longer with couple even in to that the is a the we'll always Ib a see remissions months wait out patients But is of nice think,

So I program think year. stay update that next tuned for

next from Allen question Our Baird. of of Jack comes the line

the on CLL a question first study to I I the of the mention see was had cohort the Congratulations didn't release. guess your I in in team the ALPHAX progress.

So maybe touched on bit I missed is just ongoing? I and call. should then, you think it still quite the on how planned And And about But there? think that path we go-forward Zach, the a it to on the XXX RCC. you the looking of you could what how and just for see standard I the program and about bar durability. durability for from think was elaborate you're care hoping existing XXX in

is I'll second currently a When in one. pipeline, are we different sort the have I the our very And without field. important XXX, be at the top look question, priority. The ongoing, and as Jack, perhaps I'll of the Zach for study CLL overall and prioritizing ALPHAX consolidation and shown the first in that question, process answer programs. could take the a frontline Allogene entire for even are realizing we of is study advanced have potentially the program the this we

So we of XXX it's program. program, with accelerate what are also time spending as lot do. we tumor can a of as solid us giving certainly, about the pause much to And to the sort

be a of program So update part and CLL the be context, will in in providing the is we will prioritization, it study but all year. yes, ongoing, next this

Jack, then, sort speak to it of a to little a broaden of generally. elaborate bit just And efficacy, kind bit more on I'll

with So checkpoint a point in the this recognized program TKI want designation has first, post that potential relapsed/refractory FDA patients I blocker. breakthrough to as again for out RMAT post

outcomes that from that's of So I are well as that fairly other third both a are think PFS in as there, a point rate is continuous look subset out And modest. if that you the therapy. response there patients I'll at the line, thing

of of period therapy, or it's to remission.  And potentially attractive speaking, that's we always have and one an different treatment-free rate context. been here response of and this is offer in equivalent what attributes key a generally then points improved CAR-T the So I think and no

have in to So I of these for And patients that's, to a what together the and were that lines very, would that where shakes potentially except we're put with able think hoping do take into to to we handful nobody the course, of PFS mind the therapies, all as months. patients of to and how if but happier out and I than very durable up on themselves, we remissions. how we have I, existing of said, see order be it the well, wait

is quite on who to this our constantly low from looking we and investigators So bar hear trial. are patients here, that the continuously put

support So lot investigator and have forward, seeing their benefits they're from a here patients. continue real pushing to the community we to of

line Our next of Amin Piper the Biren question from comes of Sandler.

a in you are ALLO-XXX, with the then Zach, for the design give what of Phase guess to with expecting see I? you on go to I type a of And IND to do FDA XXXX? kind on durability planned indications to of you need meet confidence imminently, ALLO-XXX, what the pivotal end at pursue

Zach?

Yes. Good David. Biren. question. Thanks, Thanks,

X remissions and in group is deep are said got X I've the are Phase patients in what responses the paraphrase first in confirmed in ongoing I'll regimen partial in low at is who think so We've of I -- nice months. Ib bar these X XXX, on far, the So treated which who the that and here.

and in-depth think how more We'll granted wait to fact And it RMAT treated therapy. and this we're then old subsequently So that have that to days potential go by the for designation, enthusiastic does to come I that over of us than frequent FDA.  So The we to designation, with time conversations to access more develop. about of durability few this have virtue having they're patients see time. this kind is they're have conversation data just and the nothing think comes. which going is and those a give the continuing in to deepen when just now, I they're have for

conditions. is there indications now second question the as for rheumatologic of that's far out the the As preponderance on data right XXX, in

lupus. is foremost and First

said going all this along there that our year be rheumatology. have to We in focus we're starting

pursue but others are said watching and data exactly a beyond in be rheumatology. suffice how the indications We're taking which see path that to We that, we're really say, excited to to field. very order. going proof-of-concept But about develop we're are haven't We're that we what it expanding watching in to going yet the data. follows

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

I pathological autoimmune cell David, talk response T progress. importance and could the wondered B in Great breaking of if disease. cell about you

the very lot we've seen seen lot cells important. are on But B focus the people of not cells So talked heard lot a they We've involved. which depletion B-cell levels, how we've of many when phenotype have of T a about seems on a and focus very recover. the

So your with I'm just about that product. how think curious as to you

the mean antibody probably contributor lymphocytes that lymphocytes differentiation beyond other are the cells. That express main John, between one immunology of is understanding. some producing great the B as And T different in by go way, to sort that development as the response, of complex. maturation scientific the these I enhancing of involved question. even CDXX. cells the you goes my But cells. other into well the B-cell to leading literature, B-cell is B-cell still and also interaction if cell that the they And

us thing the our cell phenotype. addition in to is going become I can returning a on, the component. equation the an cells very already after rather minimum some lymphodepletion. both potentially XXX fully a have into B early there single with in perspective, a CDXX depleted, incorporated address indications think important hypothesis. ALLO-XXX program, even and will any that allogeneic, what going They when just kind of the to need And can the maturation is T are another you have pathogenic B-cell technology that to B is undergo they when don't enhancement. a bring again.  And biologies, get in pathology activated So by after a and shown That's us more underlying I the to DAA B-cell than which we as all from mean to has use have it, allows Yes, naive that's CDXX cells Dagger

investigation extrapolate initial underlies plan we I to into and lymphodepletion something of that can the indications, is think during in our eliminate this patients the autoimmune or the disorders. reduce autoimmune that ALLO-XXX with

Eisai Congrats from RBC progress. of Capital. the Our of the Luca line on next question comes

been or if main evidence for microenvironment here the on have is you tumor here, Maybe tumor RCC, historical are think for Wondering here? I Zach or aspirates issue any solid any you something David, actually tumors. of which the cells do infiltrate kind have renal that biopsies CAR-T suggesting that the has able to

appreciated. so maybe the clarify, that So to and fair then CR? much color not to any responses PRs is And there, are all it far assume just

that Zach, do to take want you question?

Sure. always, great Luca, as questions.

first So answer the the is one, yes.

tumor of the we couple actually a that do and in figure poster have after And within the that weeks have have that number aspirates quite of we out. really first a infusion. biopsies We collected lays

the almost and of figure, a convincing it's get robust, ability In to And in biopsies, tumor the fact, peripheral site the be is pathology. is essentially blood quite at transgene find dozen that getting peripheral in encouraging the quite the time.  So of need source blood see and the extremely that tumor there's in samples. to all same cells of to contemporaneous that actually equivalent of into of the terms biopsies in we those ALLO-XXX we aspir XX be drawn the in bed itself to where CAR

who metabolic PR. about had second have we complete in did antecedent PRs an a and patient your confirmed CRs, Regarding question remission one

expired remission. infection. So and Unfortunately, a complete that from to deepened it PR patient that contracted that was COVID a

the sort remission. a was addition But and deepening to extremely in an So in when of remission unfortunate complete patient an that in die infection other to situation PRs. from you're ongoing

of next Our Samantha Semenkow. comes from question line the

prior profile? on up that into on choosing burden contributing on follow context about technology ALLO-XXX safety are events that disease to in some thinking that could how that your for CDXX the to the wanted thoughts completely dose there underlying the how grade just a context translate in X the is what overall rationale And targeting of could and the safety be any of just program? of the confounder also your for data autoimmune understanding you're I the Dagger But particularly and questions is here. a program,

question. Samantha, the take let me

like believe drug in online especially We any the the development, findings safety XXX all the very But study, pretty poster like will in are go looking soon. I do carefully.

So situation, usually it these very be of options. are more mean are will I heavily out detailed. they that pretreated pretty in sick patients And running patients. really of kind

is that trying happen autoimmune through. patients I in think is we with may there you And through read so really does effect disorder, occur, have that the what pharmacodynamic at this read the to development. don't enhance of but the what is, extent, but did some does events Dagger much technology, do these second the how yes, drug And to autoimmune to is this CAR-T.  So ADCs of to can the with technology. yes, really question Dagger it develop end,

We and are safety. good dealing find efficacy is And have to CAR-T, drugs, balances then right for with a And place that the active right we the always start. cell lymphodepletion, to the which the out dose.

part these else, of are anything program. ALLO-XXX the will we before, So as as the said the that like I advance I things study Phase be

Matthew line OPKO. next from of Baer Our of the question comes

about comment some in in often just off-label I us. to we're kind would one if Can but a the patient randomized on retention exists, form we versus that that treatment. stay hearing? to ALPHAX? the Because why know can you wait trial theory like that efforts patient of is consolidation question of from maybe talk choose get don't watch you and Just even

complete Matt, what's radiographic meaning periodic is different And give a care undergo scans treatment they me the to and interval wait. little question, in at large break. completion take ACHA watch the the they after disease. and a B-cell treatment. occurs the happening bit after of and watch The that see of Zach standard let yes, it of lymphoma that wait, to

and that And In to terms getting can conversation discussions carry particular in they'll feel who to that with progresses, on our when they patient patient of retain on is of retention, about event. survival. obviously, the patient with that, very already them study available the the care when I to is question the the they study, the setting, mean, patient be enrolled are is available I primary out they the of the patients standard sufficient event-free But the progresses, The primary any go investigator, in patients them. of that endpoint mean, the had the for ALPHAX our best in this the study.  And treatment.

event-free treatment, an starts analysis. that survival next the I somebody mean, the in when So is event

from comes the Sami Colan line question of William Blair. next of Our

This for is Brooke Sami. on

off of the going the of So ALPHAX affordability, on time been else? it something on to feedback wondering physician again. with potential what has And use, first community aspects received we How ALPHAX in trial? is Like valuable? cema-cel interest most use you what line treat is are have or

take Great Zach, that? you question. want do to

Sure. Thanks, Brooke.

enthusiasm than say been has really early to I Yescarta. higher, and part of that of is days high, the I those having for at several Kite as I of overall, ZUMA-X So mean extremely ALPHAX the that if the for led been LBCL the trial. approval can breathed years. not of lived the high. third-line Honestly, enthusiasm team level in

physicians LBCL think this fundamentally it's of change that I your that of broadly will a they management I usher question, the think new in is recognize and successful that, is kind of you paradigm.  As all ALPHAX think why as era which those far So that second the if mentioned. part features

prognostic then fundamentally an result, is be initiate is dose new MRD to paradigm with shifting future because experience I access CAR able enthusiasm experience or CAR-T see something a That from this. MRD it's think to being management. that this the how and novel CAR-T literally them result. giving the being is sites on they that off-the-shelf academic you unto implement have any a to deliver First to accurate therapy alter to of been revolution and of respond can see curative from the of coming of to lymphodepletion the positive the tool highly cells LBCL community that that in sidelines and enthusiasm we test, T have We beginning.  So within days frontline do of settings that potentially don't this And see itself. receiving CAR-T do in able and immediately sites because a able community to that sites, lot the could from

lots we're feedback topics that really from. a really of positive So kind it's bag of hearing grab of exciting

Our next question comes of from William of Bernstein. the line Pickering

about Grade X I safety dose the the you AEs. quarter. including on It multiple looks ALLO-XXX. the like DLTs question the at expansion cohort, using had had one you're in progress this a of that Congrats X level

if it's the you to safety XX targeting see the less patients could full or of more this cohort? acceptability how the in speak for profile, have So just you're you you once data unchanged

that Zach, do take question? to you want

Sure.

was in that the same So FCA was conditioning, patients it but dose, was out it DLTs were the in who it the ALLO-XXX. XX of I'll million, cell received point had so inclusion

DLT cohort. limit had So those in reached that we the

So we level beyond dosing advance did arms dose FCA in not X. the further any

efficacy encounter DLTs So evaluating the because in of X-part the arm, lower the dose we overall be intensity exploration in seem the X subsets best FC-only in that lymphodepletion, and the phase. to the is did not in the right, that treatment elimination the of that were we cohort

was So that's selected. that why

slightly. But a been X X the there previous press exposure that release indicated. previously was disclosed DLT going to was XXXX autoimmune never before we to other have back of study DLTs kind in on and when any we And AACR. we who One hepatitis. had DLTs, take had Yes. presented our checkpoint in at And patient that as findings inhibitor safety a

perspective. So the the communication. it it's is the a that a described this second protocol again, data but as is in from one cardiogenic somewhat shock compounded DLT, And is DLT one

Our next the comes James. Raymond of Laura Prendergast of from question line

just was therapy has pretty indication studies for the these autoimmune enrollment generally of slow. cell in I been rate on progress. the Congrats curious,

maneuvering Phase on these entering how XXX headwinds? planning guys I, you about think you As are

the And enrollment sense the Laura, had enrollment pretty is very slow. I a the the that's to beginning. X, topic mean, as months that I picking But you're have is great up. get involved mean, once only mean up. case, the in were are CAR-T, are exactly get think development. of we CDXX the enrollment CAR-T familiarity a what not we we into the but autoimmune I studies they I with general everything are who will administering also when investigators that's away where things about familiar experience that lot And going learned I somewhat takes the pretty in seem going our I we some in the ECAA not speed CAR-T, the closely mean But certainly X this definitely, present physicians with other ago, are status. CAR-T, typical. of any into But seeing.  And CAR-T complexity dealing area during following the like -- question. with be companies an in in logistic in are really with are CAR-T. we allogeneic getting which the we

Thank will as to the autoimmune, able smoothly. we execute move into are we very we hopeful So studies that be you.

management over question-and-answer our I'd any session. to like to conference back the turn concludes additional for comments. That

I Yes. very ways each patients bring you transformative we remains T diseases. off-the-shelf operator, journey. much to milestones, or products to with to realizing you cancer that reshape that, potential the autoimmune new on autoimmune saying of And now clear with joining thank us AlloCAR across by diseases. that move and commitment for With therapies just landscape may And to our difficult-to-treat end want treatment oncology could in disconnect. closer this

Thank conference. does you program. today's for This in the your participation conclude

disconnect. now may You