Allogene Therapeutics (ALLO) 14 Mar 242023 Q4 Earnings call transcript

Thank you for standing by, and welcome to Allogene Therapeutics' Fourth Quarter and Full Year 2023 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. Cassiano, please go ahead.

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

to you person an prepared will get as possible. best keep call to ask we and as our your do questions to Q&A session. host will many Following limit a to hour . our remarks, We we questions to as X per this

Joining and Officer; me Research Zachary Vice Chang, Chief today and are Dr. Jeff of and Chief Roberts, David President Officer. President Medical Dr. Executive Financial Officer; Chief Parker, Development and Executive

statements These planned financial to of regarding statements product ongoing change. XXXX efforts, success subject release can candidates of of we our trials, information, based A and are future safety disclosure timing on clinical be and the today's forward-looking are description and SEC our efficacy our forward-looking potential documents. making During call, guidance, include will and and and presentations, that and press in be current capabilities, the development research may risks other assumptions regulatory data expectations found manufacturing filings, certain statements. among latest things. These

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

to like type have take all I our look opportunity is call, than for Thank today. and norm back, who joined the of you you, ahead. to this thank Christine, would the which looking call for Rather

true XXXX feel beginning and the beyond investors Allogene, investor therapy. our seemingly our the so conference resurgence even by renewed at would in is thrilled from shared sentiment enthusiasm returned fall. to Boston, we in recently also announced of of biotech this an and argue the have I many a following for cell more pivot for were ] [ We

trial, and with which [ that ALPHAX attributes creates cema-cel innovative the patients patients our part specifically our distinctive of programs. to ] meet B-cell could embed off-the-shelf unique creating CAR-T large needs reduce alternative as to is From of for the designed curative lymphoma regimen development a autoimmune first-line reliance advantage lymphodepletion, an focuses approach possibly for our on and with on an CAR-T of disease a

using We an CAR-T outdated are longer no playbook. developing

and resurgence There this in cell with gathering for FDA there was January, almost this potential finalize the trial in we acknowledgment groundbreaking embed in other and all insight is lymphoma work for significant rates. creates revealed first-line and pivotal cure and was and leapfrog the one the constructs that dramatically do, what feedback which the a the the established of needs allogeneic and using for CAR doctors current future patients viability expand of is and on investors platform, to our products created play the design fresh of have Now of perhaps both role an This away When a inform consolidation frontline example [indiscernible], large allogeneic right to treatment. we CAR-T is T can of greatest our can opportunity. meet our therapy. in be trial from improving design approach cema-cel ALPHAX. based the of goal that discussion our trial in XXXX we trial in of to first with B-cell developed

standard understanding the talked in opportunity CAR-T design together treating truly where about more treated. rare of or this a to open minimum could the deeper residual opportunity of U.S., and of the innovative The only the trial billion most Equally This earlier you the on community-based be vial unique, in new trial against of presents could randomized patients the MRD, first-line in market center is a in Based allogeneic and on with drug to setting. do could to available disease, the make care double and U.S. upwards important potential addressable line centers itself cancer easily concept the is oncology endeavor type be are ex patients of of the something when in becoming revenue door benefit curative. we've expanded observation, $X prospect just the ALPHAX, when a

by in autoimmune in program is Enthusiasm AID asked CAR-T is most ALLO-XXX second ALPHAX palpable. for or AID. Our investors disease after

already are the approach. and we our mean disease. However, we experience could future have at X.X The CAR-T deep undifferentiated of commercialization. hard-earned or uphill rush not to worse an an to battle that for applying chosen result crowded trial our design with dual-targeting enrollment Instead, into field in specifically autoimmune

reducing is centered critical and commercial is scalability or on absolutely design future lymphodepletion, believe we development both for and eliminating rapid which success. clinical Our

expect Phase XXXX. be trial clinic We in to ALLO-XXX in with a early in I

core programs X also lean allogeneic next Our of CAR-T. into attributes

to poor aims opportunity setting efficacy. need Our growing known inhibitors. second to believe in fitness any an are the controlled is of new U.S. for unmet DTK a to product in the CAR-T ALPHAX revenue with T-cell disease barrier the lymphocytic in attractive allogeneic We limitation is suited represents particularly whose patients Relapsed/refractory overcome potential address commercially leukemia, by $X and/or a range chronic autologous CAR-T BCL-X cohort well billion third-line where among and or not in the CLL, CLL cema-cel

look the reopen could door program. charge with approvals of it interest in our CLL, New to through and we

be we planned the from the A publish believe comprehensive CAR-T plan TRAVERSE may CAR to persistence the TRAVERSE that quarter, of challenges, mitigate treatment-associated potential fundamental solid ALLO-XXX renal the eradicate needed trial expansion what tumors. but the algorithm AlloCAR update In of to our are tackles one maximize Dagger hardest for cell willing an in industry to cell ongoing carcinoma leverages we the discovery year-end the tumor. to second trial T. to one response undertake compromising hyperinflammatory and more without is to we solid optimize Our XXXX. T function technology

address commonly asked more the Now I'd our some questions Zach like progress. of over about to to turn the to call

Thank you, David.

enthusiasm. investigators I'm has are pack to for although you because share little very the can alike to gets relapsed/refractory about As CLL It's tell, and T attention many excited that very potential limitations CLL strategy sure all that in a stated. the that I'll that the remissions ignited that and new start punch. a years less powerful our with investors CAR ALPHAX, we waned than field ironic complete it but excitement we've ago thrilled

step a much but CDXX alternative Recent treatment CAR-T is CLL, New need patients there relapsed/refractory with these patients, autologous remains but inhibitor a positive room approvals been has improvement. still effective for offer therapies. could and data Bcl-X for growing there needed for post-BTKis for a

relapsed/refractory makes advance the ALPHAX investigator patients, late-stage T these derived Durable cohort responses T an CLL end of high in for donor initial and healthy T tumor enrolling treated and There and a year. of by XX X will patients enthusiasm have an administration burden cells The with and plan unfortunate meaningful study, patients Phase dose onetime is difficult. I simpler cells is AlloCAR with clinically reality at include logistics. new is dysfunction active by that scientific driven product data highly to now could circulating manufacturing we create strong rationale from likely believe that this This a hindered to cema-cel. cell

eliminate approach autoimmune wide reduce for We meet believe a standard need even chemotherapy, patient be our requirements will in experience patients. demographics, we are critical to unique general and with advance. ALLO-XXX part with cell next those The tolerance of about in cancer I'll disease, very the to procedures patients taking or now large because leukapheresis is risk the therapies effective for therapies. the lymphodepletion these availability of of talk and these rheumatologists intended different than of lack

targeting owned cells, role reduce the or CDXX-positive and activated standard is site-specific dual integration-based both of cells eliminate chemotherapy play CDXX while in CDXX disorders. AlloCAR T which designed CDXX-positive next-generation, T B Our need autoimmune targeting for a wholly to

We addressing targeting have targeting the T position component. the apart and this dual long-term are highly We invested success. cell believe in in pack for that AID us that current indirect targeting introducing CDXX CDXX or to will diseases to increasing All which with possibly us and in allowing in programs of B us pathogenic underlie from T CAR therefore, solely approach thereby set benefit. clinical the involvement elimination has indications B cells demonstrated strict CDXX and cell direct beyond autoimmunity, effectiveness T extend differentiated allow potentially both

much course, Phase I hundreds with early advantage more donor potentially the additional would to healthy meet readily of trial of ALLO-XXX demand. a trial Of manufacture ability off-the-shelf is doses Initiation single XXXX. expected in the an commercial CAR-T this enormous leukapheresis and during execution clinical provide from competitive could

platform T CRISPR excited next-generation to in very are of with use support our disease. gene to have proprietary for Arbor technology AlloCAR overarching We Biotechnologies their autoimmune editing partnered

a assay I together, of that accurate likely mistake, the design year with aha by securing am our academic get the and study Allogene hasn't be ALPHAX. of highlights The By potential particularly it until things ALPHAX, the To advisory proud wasn't and simply and innovative life why a elegant like of team, career. Make anyone was of onetime a this treatment to of a KOLs of is the comprised alike why needed could the one work. asked, excited we hard support we community this possible come and tried powerful administered boards bringing that my no Finally, FDA It broader this before. now. both and X immediately. of investigators comes with to and highly MRD already novel trial oncologists is run trial this

to treatment Unfortunately, design never believe results trial which recently, R-CHOP patients upon no of We and cutting-edge to respond residual The been at chemoimmunotherapy completion way the diagnostics first-line know will would the disease of patients developed X/X consolidation demonstrated Foresight to for would have test cancer in identify the right Approximately go experience relapse. to who leverages ALPHAX ALPHAX builds has who a on I relapse. of Phase which there the with patients cema-cel. frontline diagnostic investigational initially by now minimal recurrence LBCL combination. their the disease until and we have have trial the

to a following positioning of after treatment upon can The disease to frontline builds I relapsed/refractory frontline the standard therapies of has be patients disease. and to that burden of administered MRD. MRD growing it and safety cema-cel and in administration Phase efficacy in ICANs standard treatment wait radiological and disease its treatment immediately on CAR of evidence of profile R-CHOP no as rates watch Cema-cel eligible ALPHAX for with safety the the understanding become this ALPHAX may decades with our low off-the-shelf T of in patients permits for further use patients with CRS seventh available all outcomes. onetime cycle low already setting with of both outpatient been simply improves advantage cycles improve of X to patients relapse. discovery takes of care to

could MRD A of What's results. requires incredibly outcome Why? to be impending trial frontline that the is therapies autologous in an this exciting could immediate X to feasible. prevent test post are result happen X with allow with embedded an R-CHOP to less cema-cel roughly setting and far treatment MRD-positive cema-cel the positive response where definitive Consolidating action post relapse. onetime days pivotal

available the As as have T on line nor have penetrating logistics be centers. is patients. rely had reliance there referrals these will be that centers on cema-cel adoption CAR earlier CAR-T autologous hindered the for Use we cancer same have to intent seen, of and community cancer CAR-Ts community difficulty a in won't accessing complex

for waiting to cannot differentiated be treatment reproduced cema-cel their the other as centers. allogeneic any Start-up positive to for what The XXX attributes with modality will are We An by modality. or been of observation. activities been doctors for consolidation at is have autologous the the in these of standard of have ALPHAX which who these either frontline is care, believe cema-cel like randomize bispecifics cema-cel current CAR-T MRD approximately entry end study initiated. patients therapy

patients trial for X including initially standard to reduce on become without could outcome a have this consolidation, for pivotal answering of CAR-T The mid-XXXX for treatment start cyclophosphamide care. potential and fludarabine arms, potentially of the our questions is lines. now in The one cema-cel approved significantly We only The to frontline in additional be ALLO-XXX. call pipeline design curates seek treatment will forward plus with who wide include event-free ALLO-XXX with improve trial conducted to and later will cancer the X planned survival the over Jeff. or need with the most endpoint lymphodepletion community centers the line the any to I'll and cancer of primary Q&A. and during look array hand allow earlier centers, you

expressed call. exciting months broad made Zach. speaking been at team. and to look echo like for and is inspirational on our very autoimmune enthusiasm continue with of unanimous prospective and this something strategy comments David's a It's and current the our We appreciated beginning CAR-T the greatly been our investors. for enthusiasm you, having program vision I'd trial forward Thank few The has share especially year, ALPHAX, updates to ALLO-XXX, is X.X TRAVERSE, that our to career. to in ample throughout CLL for my opportunity our and disease. unique Such

recognize vision Our and that cash we critical. is is runway bold

actively reserves. Rest and build acknowledge also that cash, do, assured pleased our million however, following to investments, are that the pursuing a the strong with changes January manage we into that must focused made and opportunities that our XXXX, We announcement extending ending debt. runway We $XXX.X early focus. we have remain but actively strategy have we've in cash while a XXXX in have extended and be we cash cash will our no equivalents costs, balance, runway

look approximately $XXX of we million. a ahead year cash a XXXX, to full we burn As expect

$XX operations our expenses stock-based XXXX impact into $XXX.X expenses and includes million we which any our Full full noncash support compensation. operating which This approximately to million, will GAAP activities. cash business noncash estimated stock-based guidance be runway from million. that in development expenses to development expect with forecast XXXX. $XX.X expense excludes We perspective, million, $XXX were our included longer-term compensation associated approximately potential research continue From XXXX a year of year

year full expense. and included compensation general which For expenses $XX.X million, the XXXX, million noncash of administration were stock-based $XX

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

With call open for will that, the now we your questions.

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

Congrats on all the quarter. progress during the

the first R&D this I the to regimen. by ALLO-XXX saw wanted ask renal at about a response FCA we since been Dagger was 'XX approach cell November personally or your autoimmune it I without fascinated the when So full have technology in ever time unveiled around. Day

technology deployed to to for So see being I'm glad that ALLO-XXX autoimmune disease.

altogether and another lymphodepletion takes big removing further. However, AID step

in So briefly question or question, how trials. talk the potential this to why a feasible Allogene's and can innings you is of clinical in test do me, the early maybe you think And impact about would a autoimmune, forgive to just for the second BIOSECURE intend that WuXi you half from Bill and business?

questions. of here. Tyler, Dave I like for you're first one. the your half how Chang that Thanks squeezing after And sort question

ALLO-XXX, differentiate immune dual do X folds. not cells, there CDXX also how really . I had is this ALLO-XXX on the going are really is key getting place. It's pretty as what which crowded other cells, is the remarks the mean, design into And products differentiation disease T role believe to pretty One, pathogenic already CDXX play that's from to a mean a this depleting to commented are the significant I this built product manufacturing. that the CAR. On B allows can the CAR deplete activated Zack indications. it is a the prepared positive we ALLO-XXX And in T the CDXX we being during able from itself. in autoimmune just is a

to a without on is, cell part products deplete ALLO-XXX CAR-T antibody. to allows, concept allogeneic other work having in Being The believe, Dagger-containing -- the back or an well of we being CDXX to T as CDXX the use dependent even lymphodepletion. the product to able activated

much expansion players laboratory not go doing. program from eliminating is just the are And think has can lymphodepletion, it off after going it's cells we is either or start a actually greater what with much clinical we study. coming components TRAVERSE potential us Dagger our or T the tapering starting further. CDXX also cyclophosphamide. have and [indiscernible] the one, that from the very CAR-T We through lymphodepletion CDXX even data point activated on to What a do fludarabine But CDXX ALLO-XXX par can concept. of So even is for is and --

I conduct be for we but not that success. commercial indications very So just going future the also a interesting is the to autoimmune to this think critical rapidly study proposition the is in believe

long point leads system. ALLO-XXX, I And we of we the T a the the deep can don't Not really immune indications, that need sort in This allogeneic, so it scalability. reset persistence. duration the an which third of of lymphocytes of to really is the CAR persistence, the only think also as believe enough duration depleting pathogenic autoimmune is the

the when cell effective believe for that we dose. construct, at going, indication very this the So we ALLO-XXX be think can that we're about low

And of that priority programs very have So XXXX. we the is one this are as have excited. for we top we said,

our least our And we Currently, I/II readout I'm expect going is portions second the much to that about end to time. start brief accelerate I what's the response. I early potential for something at readout, data WuXi talking as to at on give Phase -- can. data XXXX, leads so business. been very intent that we ALLO-XXX is line mean the by the and study in question, XXXX. believe some We doesn't to that time Phase impact have with as a it of we Bill manufacturing Allogene, going always BIOSECURE And also all. Allogene core and to

covers in chain we not For CAR-T CMC why that really the that's built a fully building And and distinctive assay in fully is the manufacturing supply manufacturing and scalability that CAR-T analytic manufacturing. of dedicated try we also just the differentiated key. where and that in we not early to believe we days, expand AID, invested process X hem/onc reason, integrated will advantage team but CF and a allogeneic from facility, use development as only be which we the but call very

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

your specific about apart think to just go looking disease us you then speak you going the you're from to CRISPR-based Just in program, the basket here strategy technology indication, preference Dagger how that gene how the starting within Arbor, help to profile out? for after regard autoimmune and the and bringing regard With to with you're here. maybe Could technology about here. understand diseases editing

Thanks, Great Salveen. question. is Zach. This

is us do partnership away sort to what would So and the wanted technology us internalize that to really Arbor allow of the what independently we that -- for opportunities create we technology. new TALEN from with move

the CRISPR-based us so believe And in overall flexibility have introducing will which improve product patient we population. platform this Arbor profile to of will allow the that profile and safety brings for unique also this site-specific some integration

a So it new . and tool fast in is with directions design. go us really, to to product allow

matures made the As program, being which share clearest learn as looking the closer we coming trial get the willing we other to the be far the be into concept and details. that about that inroads to the in from of sort at launch we'll clinical course, little can clinical goes this will data what over field the I'm learning we a eager that and Lupus of is say point carefully in of bit months exists. as to more proof indications, indication speculate of

we we reduction much including looking And a get are push closer. all. lymphodepletion we very into But so how can, little the question The attention testing related we'll at as be again, of carefully we bit get far lymphodepletion at to before, potentially to will can Tyler's no we as design this that study, paying that.

in the to plan stay closer a we the early details development of for on So the get launch XXXX. bit clinical as little tuned program more

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

for you around walk I latest if ALLO-XXX. curious your We're the through thinking can Phase

like doses many already And you a patients? gravis. you are now Are escalation should which myasthenia to if players do how there so, doing execute? lupus few indications and expect Specifically, in dose since plan autoimmune in indications we quite

stay that say I'll Chang, is take I tuned. What DAVE Great Brian, question. question. can

those and terms That's In differentiation and being question given different our they B called to think the X study I objective those clinical are well. that and conduct I studies, we steps I able Phase the addressed conducting of I of more indications. like and that of pretty believe team's the lymphodepletion, more have dose about biologic the there from clinical be mean history through details with escalation of that execute after can The XXX. to cells cells. T out: studies coming go of needs going after things a to are

out, with want the whether of no we will or as immune also, lymphodepletion But same ALLO-XXX administer is can have have one questions reduce we and the to we phenomenon. that answer important type of resetting called

as be leads And I to how will really that being different that these I possible. -- study. trying Phase things of but design we think mean are of as the to study that the couple a course, focus I get now. to designs, of answer that led quickly all right discussed

comes of of jefferies. next our Michael question the Yee from line

the gives This from be And these for fashion. would ] I timely in to thinking ALPHAX. some this enroll do that to How able first-line enroll when I you'll be you patients Mac expect guess, the on you to wondering, a in initial about data study? is able your for ensure Michael. autoimmune a corollary, as study [ we from switching ability guess, confidence study focus, away was I the what

for is this Matt, the Thanks question. Zach.

that have it's large practices In as as enthusiasm, study as So a into far, seen question, have of able this the treatment have academic why positive. XX the be that extremely enrolled jump the who response and have to yet to uniform, so but investigators are community not for word, KOLs spectrum be that we a been T out part quickly. across made of to we the from your patients, all been volume to the of reached the CAR what I has far the part story way been XX, years, confident CAR-T, oncology will first think study we have

program obstacles as can. seeing they of left clearing quickly and engagement open right. the from levels that We've are seen investigators, to as And we

palpable is ever be people there after curing So a by patients a from excited in approach enthusiasm are frontline very LBCL novel This of possibility is preventing really of the innovative around that. to of this occurring. studies level really relapse concept, part and driven a to and

we the closer As the is a bit start a study enrollment we'll to little as on I far going as a of in data more when of data get goes, little in we complete this to midyear to year, be position and provide clarity when -- think will be available.

said that What currently for here, everybody is I'll and that MRD -- an MRD conversion the the study be have we will that have positive. analysis reiterate to when comes will is designed middle -- year positive study from slated to next we negative, into interim we is examine of

the of we of and carried will of accrual analysis the will as to looking use MRD evidence select translational as we're for well rest period. be outcomes, for So that lymphodepletion and interim forward arm safety clearance the that

design, that that gate, study So through as to paying all and a will pass be who we plainly make attention. are to will we modification the visible

detail We however, to the that's will from enrolled. this that is study granular because first be very pivotal not, from analysis patient share able

starting count towards will And of so end again, that's this pivotal for required the middle of overall study. these year all the patients

be results, at year. will next sharing by So sharing unless we not a of the we trial middle update integrity data those jeopardize

is with with can think you I lymphoma technical relapsed/refractory mean, wait. watch other therapy, all the large we on believe after B-cell of all, I focus the before what perspective, we really that When of T on yet. built And I from highly that [ Brian shared we observation, patient, which autologous have of mean generated CAR-T question is par and CAR and the the the the this that's any all mean against comparing this I I data which at look study, key. doing say execution the would setting. I enrolling that are that think we And this on ], your in I is about don't ALPHAX, the from you, data allogeneic in add, ALPHAX derisked. companies like

feel we that. about So pretty good

enrollment, information is is study derisking about key. the think Execution And studies. I think the ALPHAX I pretty start that frankly, significant and a

So this as our hard stay tuned. working team sure study possible. I as make really quickly we execute is that to mean

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

about of like on about In you're as you're can the middle any data Congratulations question, analysis? you interim context XXXX. provide past bar internal to is last analysis results, for study ask wanted the And that have the same that you vein forward number pushing I sounds outwardly be to understand the not but progress. to that may share in I it kind of the there to you're set? of to an around interim as patients relates the looking thinking that looking reach it planning that

Jack, thanks for the question.

looking analysis. how to power going that sort too going of of be to it's question, a second your part to that many, going call. -- many few. And make want We included I'll say good the So gone with for. be not maybe bar to patients that an in have about is statistical too detail there into we we unhelpfully, internal are enough not we're haven't respect are how to

that to parts which through in this, therapy. cema-cel wait. right? that We and care, to we the out, are X that Phase really we've want David experience We pointed think, watch active that improving there's know And our an derisked is we make So is largely standard I. as sure upon of question

FC. be ball. that clear be we'll But versus of to the course, we of be we'll that paying that set of it. additional FCA And using think able we to So make attention of course, selection then to will criteria we an have

prospectively is the going is this to So right a that analysis well very think us answer. out designed we lead thought to

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

disease. more the little autoimmune in curious could bit potential Just if a comment regarding you targets

your also sort targets is for approach that Other there looking we CDXX, have CAR-Ts with are crept during which targets of on the be are autoimmune B thinking curious say at Obviously, cells. at life better? you as of dual lupus. considering So could but companies namely And your BCMA different companies treatment out CDXX, of obviously, Can targeting. cycle different disease, additional up at times are But and looking sort some that. to just why?

Yes.

targets. the a looking mentioned, that -- this sort of is in that into. most this broad that a are of different look you test and terms different question. coverage players clinical And you BCMA, have I great at have when . targets. and if the think the believe the something So CDXX of from that's B CDXX, probably expression, targets probably we as But CDXX that data find ultimately, John, these cells, at we than I topic But to you is suited other also frankly, look oncogene better

that question concept we we sort around think established and lupus/nephritis CAR objective commercially well. this good. If generating be indications as of been primary with can actually that is in. early about is that the also the attractive T proof And indications lymphodepletion. indication proof has the the from of very of requiring other very of concept is are where CDXX interested would The not a

approach. our remember, distinct I definitely know But ALLO-XXX has the it's is So and getting in play. crowded. a differentiated very lupus

falls even we we and may if have in sclerosis multiple think opens be being after one. -- other I also T to as affect that field. think can activated a system, go So disease able good in. will the others, traction to differentiate is Autoimmune nervous the class up crowded diseases good have potentially we a of a sufficient cells going also that I not autoimmune to the door from diseases, where the CDXX but

right enough yes, indications. we that finalize to next have have don't to focused frankly, we we have decision I after certain So months. now, think time But be in go to have to X decide to and X we and the

So stay tuned. .

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

This is Corwin. [indiscernible] Sami for

on the CAR you thinking or autoimmune U.S. Would pursuing patients future number cell how U.S. patients of the are in a in for indications, or given of about competing companies focused ex So be both? guys you trials? combination enrolling T disease more

about companies different when potential there a assets true. autoimmune what I XX,XXX, is me. about number taking you XXX it think you patients to But into are iceberg. is different a think you when think mean mean patients not are the fewer of that's talking that go can simple after. an multiple patient are that . XXX,XXX indication. are a relatively of Yes, of are covering current there, population potential the out about even out clinical we I XX,XXX, studies than tip I probably

to do So And maintain quick that the program just we and of we becomes view quickly. something about if that as that development real concerned I you rid less think differentiation. a more as very get a our can can lymphodepletion, easily the are opportunities frankly, long is do we

of the Guggenheim. of next Our comes Kelsey question Goodwin from line

the How . of for the population see BTKs patient age think durability kind CLL. [ about with this Mine do BCLX on of and inhibitors? the you given ideal ] placement CAR-T we and that

The around that the we question can durability was expect?.

kind to of on how with More get are patients and a this what that already inhibitors responses you at given approved? so diagnosis than kind the age positioning the would are the durable want of and

Yes.

Thank Okay. you.

] study BTK patients reminder, that will [ BCLX. have as well, enroll and Inhibitors So a that

is there pertibrutinib approved. Now been is that noncovalent there patient BCL BTKinhibitor, population, shown similar That that's that drug. to in a has some a benefit

established However, is modalities, non-curative. this similar to the

the some on these have complete in actually so is fraction patients, And CDXX months autologous remissions for CLL durable of or significant a what even that patients very meaningful, we years. experience seen have can that from go for

prior with failed that patient has that promising at I'll one, And with very rates experience from looking and point consistent population more the patient low I and Number CRS population so two, we of out our frail Number population. -- somewhat is this is ICANs with that a our just modality toxicity and that have in therapies. in high-grade consistent think outpatient wholly experience a these is LBCL with. profile which dosing, do

very our players. I able even bar the getting as close this wet we toxicity has be plays been paying as by how to on in are to we while autologous being or ready year, feet meet that getting established this with and profile Phase attention that out well to patient population So data this will study exceed later share the

comes Reni of line Benjamin Our next Securities. of JMP the question from

to of be data. just the to kind the end of the be patients go/no-go thought to would of going progress. by XX consider on with results of know Maybe around you CLL. this Congrats questions What year? would there's continuing worth see you like I the only that about

setting. cema-cel there Just how do be you I of already to that, drugs do a guess, with this? of were Juno just move back just about might a studies plan And thinking combination on were just experience more Kite, a combination your to I guys know LBCL, to kind of or treatment second in type dissecting an opportunity some with that. consolidation about frontline you remember are as a given think part of thinking frontline when out in there. you wanted how way that And

Yes.

again that And probably should we predicament because probably, internal that XX% of something high as right is the cema-cel of rolls this suggests it that -- approved physicians the sub-XX% is data data why is treating rate in doing making, the the actually, well, So that that's who and But bar the therapies. CR decision the is all patients right ORR watch be an point with far into as the improvement that the failed FDA attractive having not things course, now bar believe are we that for a exactly we'll thing moving in. to and of before out the of I'll one here. CLL as is not that that's

watching be response that FDA's to the set very So we'll data carefully.

that And whether study. about data to decision as being move II a Phase into to registrational make our matures, able a

is can little around. a as floating are to relative rationale there's been Combination well. is other cells when consolidation I And with that. other fact, indications a and/or certainly with strategy our nadir as question in with but that And to a I a large challenging far the disease ALPHAX that applied idea, in proposition is be strong pursue. the avenue that that, goes to and very our or B-cell interesting to T consolidation a CAR in it is treatment biological do consolidation bit attractive combinations, an respect think testament do to focus As think more belief is has a of

And matures program as so we'll well. the looking be carefully at that as

line of Kalpit Our next B. of Securities. question the Patel Riley comes from

one T autoimmune Can targeting how on for on a any outcomes have ALLO-XXX. immunomodulatory beyond effects Yes. influence you broader might Maybe And effects thoughts regulatory as just disease since any cells on discuss patients? these direct CDXX? impact cytotoxicity such you

question. Good Kalpit. Thanks,

work is of is of our sort ongoing detailed that subsets in the cells program. So the context T of the on XXX

targeting really And certain are that affected T-cell CDXX understand there are so lymphocyte that trying to differentially by population therapy. compartments within more

being work this in the we're good of the a ongoing XXX. that from So of David in And for results now cells as to has strong T from activated target translational our the . context idea fact, mentioned, support doing been trial. able TRAVERSE demonstrated,

activated certain the what cells. that what So disorders the cells in that know vitro do autoimmune can we role in our lupus. like conventional that or CAR is I And literature CDXX supports suppression autoimmune and from or we take there's of away are in of involved think the we activated see with those trial be T we And T regulatory pathogenesis. knowing know CDXX work clinical differential

with we be of T do We modulate that cells. of the reasons to CDXX, think the addition think pursuing, in the activated able that which as those a is we'll one And specific we're key so subset effect, Dagger ALLO-XXX. to dual car

the careful so execute close of within be subpopulations study. attention to that the And And at course, we'll XXX. as we'll we paying XXX look

Our the Issi line next RBC from Luca question Capital. of comes of

Zach, expand the a Maybe more look Congrats on bit mid-XXXX. you just progress. little interim on can in

asked I [indiscernible] the randomized trial. you line setting, think PFS in when you superiority actually in when the to dedicated third trial show you a were basically running the FDA

kind it MRD not not randomized, patients is actually which positive feels FDA like However, the and okay. here that thoughts much but Any context a if And [ We're in FDA same has in lowered the to just earlier not be that of your is showing MRD appreciate trial, the negative the within from what posture there looks change regulators? from trial the despite it settings. two, me converting action of ] would fair? so, to drove pivotal One, the moving that separate bar

I question. the for contribution been So a thanks, FDA's constitute effect there's think data that change -- on would the I of don't a don't what in opinion Luca, package.

into in the single in X in have trial of what design a frontline condensed consolidation I we is ALPHAX think was the setting done third-line trials the setting.

that trial year registration of effect of trial. with will the will next a of analysis support designed a really first is way the And we've that got, generate study within the to ALLO-XXX. in speaking, of culminate So contribution a part the interim the

part question actually in that the said, because fashion, no running whether that is the required of randomized study, Now reason running we're of radiographic of to the truly evidence it disease. with we're scientific patients we this a in these is address way the want ALLO-XXX

even -- is is I we have reason designed we be requirement that would specifically it, it chance, does there we so arm how that a good as done it that for FDA's chance still ALLO-XXX. the address the not to may, for And say, does a XXX. select But COE that not that have contain the

in there there stance say would a I change regulatory that has not So been .

of Goonewardene next from Our Truist. line comes of the Asthika question

This for Asthika. is Karina

efficacy T How the fitness. efficacy T context? CLL, Following the what up considering generated and see would alternate has also might on centrally to CAR [ compared in AlloCAR you an of to superior like of in CLL rate. [indiscernible] this T XX% And CR the validating autologous in cell data particularly

Karina. Thanks,

CLLs is circulating And fitness for cells way that number malignancy, cell be really notoriously coming trial. that we it I So T I the from us by surrounded going donor-derived to asked isolation are cell primary a of those T opening that T leukapheresis the because question is like I two, underlying motivator are because Number believe to this think speaks the a cells burden, manufacturing, superior from to a more leukemic immunosuppressive difficult. fitness those that product high you that very is which think for derived all healthy the one. a makes patient often,

donor material. healthy with starting problems those of both dodged We

be course, that why is And we actually meaningful here, of we running autologous, that's XX% what but improvement we So what course, CR rate. shown But That's FDA given that with by we there meet by experiment. to decision of the a a that that. the the have is think I've will target the that been has B-cell chance comparability been think large think of at believe addressed registerable. established over we're sort able we've autologous We'll we that what happens in least the we the products there. should as potentially against see shown

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

issues the just used, testing do more broadly with no this to randomized you curious, the be any ALPHAX, will competition MRD patients broad testing? MRD setting, becomes expect having is expect especially a since you given control you arm some enrolling if future do in expected in about I'm of as How think use in this? And therapy?

Laura. Thanks,

in therapy that standard these of agent observation randomized offer there we -- And arm. let patients the to That another of So the physicians patients, -- to patients who no worried is the the going that don't an least about data observation. anywhere, we line are are not are to to approved current the direct be alone in to means who care. is

point, part they up -- of this be patients And is So standard context we to these why wide participating that far will already development the agreement clinical a work think company clinical investigation. most disease. think is would study. willing of not good trial. in a in as some management as during that patients appropriate [indiscernible] at that we probably current there very if more then patients, be be goes, which trial, see for agents a that with And to will they know the for study done there fact, start-up is going in nature the fact there MRD based clinical only a care as of that be -- we don't closely there this is of . These the a this chance sign we some the the so, is on of observation. for the will for not monitored That's competition in that patients in closely, we've

And just progress with patients profile a have no We a cycle and go for therapy. quickly is, and do MRD have treatment, treatment of two, these disease. we as long so need period think administration, these on. therapy said, seventh kind there's unique frontline that onetime or there's get maintenance after home This of a can they we complete very they -- move number patients can of and product

you remind line definitively our in able act to rapidly, patients we study. I'll third X days that and being enrolled are So to and initiated within very after treatment X

So we quickly. we know that affect can this treatment extremely

modality, with think we built-in of have, we we lead have and advantage a on strong our the that's So having competitors our of this advantage top before that launched study any

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

from could to sites. getting [indiscernible] that small total a of need these Do you're already you've to to these trial, do or interest participate? to percent level you be large In centers, the centers? expect community And centers your talked speak of be including a it about, ALPHAX you

level have really high of to competition that So study them bit quickly of that reception gotten there's be very open has be the to ready are of first little to moving extremely friendly them of the a Many positive these very -- and a enthusiasm. from among there's some open. even we to I and say engagement community been will the very, practices

So encouraged by reception that we've we been gotten have very the

this percentage we're because to goes, oncologist. as they -- excited definitely the -- are we're about some as it's to community going concept far to going going be the academic as have As centers

to be we exactly don't yet. a going continuum there's So know

the selection be from substantial community full of I the study panel completed patients will coming programs, but haven't the a percentage say of there entire in We these practices will overall of that

David to would the Thank Chang turn you. like to I remarks. now conference back Sir? closing for

support. joining you for continued Thank our Right. call today on your and

extending ALLO-XXX. patients X.X ever the allogeneic to with to for autoimmune the more and and with our for disease the than patients Allogene are We opportunity fulfill cancer CAR-T potential the now promise excited with CAR-T promise of about

putting That cell As happening about fuel needed that, look therapy. what's is field forefront. particularly year. resurgence innovation forward someone exactly today, updates to who I to providing is and what differently has throughout exciting been involved With in developing to this the excited the in the in new programs cell thinking therapies, I'm our goodbye. at

you today's concludes participating. conference for Thank This call.

You may now disconnect.