ALLO - Earnings call transcript Q3 2021 | Allogene Therapeutics, Inc.

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Operator

Hello, thank you for standing by, and welcome to Allogene Therapeutics Third Quarter 2021 Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be aware that today's conference is being recorded. I would now like to hand the conference over to Christine Cassiano, Chief Communications Officer. Ms. begin. may you Cassiano,

Christine Cassiano

for and website. market all a closed a both financial that operator, and press call. webcast today's press join After provides are results and update the today, on corporate XXXX. welcome you, This who release our to available the release QX Thank Allogene issued

Dr. of Chief Dr. Rafael and Amado, Joining me are Schmidt, today Medical Officer; call Eric Development Dr. David Chief Vice Officer. Executive President Research Financial on the Chang, and and President and Chief Executive Officer;

information, regarding During subject matters, can release that assumptions, certain and today's our call, forward-looking forward-looking and These earnings statements. in disclosure things. we regulatory timing guidance will clinical the our be These documents. to potential risks A making may current are and financial description be of found include the latest and other XXXX advance to SEC press our ability statements data clinical trials are among and on change. expectations based statements

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

David Chang

Christine, In the had our that ALPHAX in a afternoon. we communicated FDA chromosomal on based and AlloCAR-T in clinical you, hold on programs patient one good placed clinical the October, observed Thank abnormality trial.

Phase work even place, importantly Although all we Cell a brief we our in need. and have On trial today's advancement hold the other pivotal on technologies. ultimate patients workstreams multiple to the we the to update and in X our remain impact and our Allogene advancing been solid patients committed at share clinical including that our Forge is treat facility of next platform, data, unable potential will targets for generation X tumor reason to on on the hold more manufacturing and perhaps continue, preparation preclinical while our ALLO-XXXA, call,

we we discussions with resolution. have announced mind. what's to engaged in October timely lead in the clinical will top actively first on Since that Xth, we hope of hold FDA been me start a Let the with

in We FDA are has matter, but our to for efficacy but mission allogeneic FDA's therapy. broader observed us progress to abnormalities The mandated and has understand the cell field field products, are that believe implications properly which which extremely and patients. in ensure to for making generating information Allogene, has field of the attention is the medical this I'm only to also Congress of agency stated and the also also address not of therapy, product our time appreciated the of and safety team been to the devoted great the the development. we chromosomal at cell expedite grateful by

perspective, anticipation to From clinical and field the pioneer safe the drive supporting leadership our in review ALLO-XXXA they cell access the a the T continued ensure submitted to materials trial. development for CAR timely pivotal healthy and identified FDA of X FDA at potential Phase of the end our look therapy allogeneic therapy forums, donor Phase a public manufacturing have a everything its patient from in resumption we that our innovation. responsibility decrease has recent responsibility X to recognize and to Allogene's being FDA's with cost. cells increase of forward to studies. time The facilitate We and at safety As while necessary has potential shared of comes way own understand doing of

an transplant. in with we have FDA, a allogeneic cell who with the patient, our investigators, for remained interaction our close who is During received clinician, including contact caring subsequently stem

treated multiple ASH many have five failure. patients upcoming options investigators, cells risk XXX want presentations. importantly, myeloma these of alone, the for than more AlloCAR cell over their an our manufacturing trials to Rafael T up cannot product of now In over don't T XX carcinoma view to our and have heard many look therapeutic as now for T December. ALPHAX how across updated to with renal CAR preview the our lymphoma, patients call in I at of share reinitiation data and studies. turn from delivery autologous the Most excited forward of are potential of we treated patients believe have and important Phase products we and we will trial the lymphoma or We X AlloCAR the they to patients wait to our calling conference in data

Rafael Amado

Thank you.

tolerated ASH study and to has with retreatment. X well term single our will enhanced on Phase goes at David describe for programs, which in an ALPHA presentation Consistent a and our with unique continued ALLO-XXXA on noted, at the in We abstract re-dosing, to with presented our that efficacy anti-CDXX dosing consolidation simple Conference. will in demonstrated validate approach strategy. and ALLO-XXXA which will with favorable beyond ASH both non-Hodgkin's continue ASH poster data to ASH potential dose from month presented support the a updates data I be data ALLO-XXX ALLO-XXX. the BCMA lymphoma the today abstract presentation profile the cells. oral earlier on clinical compared is As updates focus next consolidations the consolidation comments feature believe disclosed this of We year, to to trial for a my a ASCO and our for AlloCAR ALPHAX chose

without allowing cells can to dose readministration proprietary strategy initial persists response therapy. to while that provide us a an from active newly Our lymphodepletion administered chemotherapy, remain of work to our to consolidate enables cells dose second of cells

this holds believe are are that the over other While studied. early, strategy data paradigms we retreatment advantages being

study cell lymphoma dose the As patients six included T with patients tied data at you large consolidation and from evaluable cohort large cell study. B ALPHAX ASCO this of treated this may a from earlier the recall, evaluable presented lymphoma year single ALLO-XXXA in

patients the no refractory the patients Events the or treated dose July response the XX% ASH lymphoma were single advancement across delivered the with overall ALLO-XXXA with both ALLO-XXXA tumor effectively continue the consolidation all Annual the the seen in at complete aplastic We CAR or be responses look In to Meeting. similar Meanwhile, previously chromosomal responses start to XX% evaluable treat timing trial program have to to in XX cohort data to able rate ICANS, the event the the partial and for six additional interests average abnormality cohort presentation each highlight the abstract remain day the the presented patients and dose second the of and following was X rates consolidation. population ALLO-XXXA toxicities, date converting consolidation at rate not the response to XX those of and across or XX. continues As continue at no XXXX the the in doses XX histologies. nine a CAR XX to the of relapse forward T infections and most treated trials, cutoff a this the of ALPHAX was identical poster understanding patients, be three time recognizing we both In The the to cohort, into study ASH allogeneic consolidation reported can streams in Phase to adverse ASH non-Hodgkin's home. cohort received cutoff. patients by receiving a continues the therapy on manageable had FDA. in reductions dose and therapy patients. with no certain T Among the cell anemia reactions all of the and T discussions safety subject be few for were ALPHA were intend in with from group prepare the and patient patients cohort, infusion-related for nearly cohorts. CAR dose due there referencing common treat data In and far Grade cytopenias being presenting cytokine data graft-versus-host patients disease, profile in days. with fixing consolidation are that dose enrolled release response receive of ASH in following the The conveniently X+ were ongoing not to syndrome, at that to the cohort clinical all and abstract an work five Grade with ASCO were data In no served intent single to XX a to to abstract single enrollment modified population dose-limiting data with CRs no response pivotal data as from and delayed of X. the consolidation halts ALLO-XXXA autologous occurred naïve trial, to therapy therapy the with updated that

overall with cohort was data the As of at the the patients at rate of assessment Four lymphoma B-cell consolidation response abstract to with CR patients XX%. five patients data the time of cutoff, dosing this seven response was response and were the XX rates the the and the data T naïve XX% in for relative and of the Ash the CAR XX% July CAR respectively. CR lymphoma, at off evaluable and previously response rate was rates rate the treated and overall large an patients a with XX% rate Overall, reported consolidation XX%. T rate XX% enrolled ASCO year. follicular In In respectively. remain was naïve CR cut XX follicular after additional lymphoma, overall XX% and earlier CR were rate XXX% the

dose ALLO-XXX were and Findings cell following occurred case of of X abstract. on this dose ALLO-XXX occurred the patients and in with abstract event we capable most data cohort cell All XX of with six treated whole, without the the the higher longest indicate CR Subject dose ALPHA plus of in our patients with report escalating study. to responses. myeloma XX% few The XX%. no to were myeloma, cases, of lymphoma, The in autologous with able abstract combination noted trials. cell program ALLO-XXX one similar data ICANS those single second protocols. was target nirogacestat allogeneic reported. cell to the therapy multiple X There Cytopenias through multiple in ALPHAX, with The bridging pivotal CRS CRS, of can from the not deep GvHD was a T remained be Grade at to data T CRS. similar in adverse from continue single single in delivered cut DLT a of contains of with was inducing previously, patients CAR is need milligrams of ASH As There to XXXX months ongoing doses presentation milligrams. administration infusion rates refractory no off. months case of that were see in the common rates new ranging rapidly the clinical follicular oral large T six autologous Grade XX% receive at cohort. in remaining to from from from for for a CAR one with on Grade CAR UNIVERSAL which or consolidation and focused meeting therapy subserve halt. of to doses X/X we standard consolidation reported will XX% current patients June ASH a were month month that reported XX was emerging treated a a percent trials as rates of CRS dosing therapy so patients. abstract XX ALLO-XXX at lymphoma and following the of B as of ASH therapies XX Infection The as patient the with managed treatment ALLO-XXX additional the of CR with six we ALLO-XXX, ALLO-XXX of at

refractory. lymphodepletion five with The the data adverse we trial lymphodepletion. reported patients of ALLO-XXX of of these Grade overall of When at XX% common months. X included for XXX prior found a Grade was with levels we'll response and therapy. be in UNIVERSAL Median rate follow-up events. two events with cytopenias. except neurotoxicity eight or it with disease positive of negative. initial CRS patient and enrollment of did including time and months time presented with occurred partial were report patients X was infections X+ on this cases across in X. five XX a duration the patients cells. best median bridging not Grade As stage Grade patients, The analysis cyclophosphamide of two-cell was of a better ALPHA XXXX, No XX reported response response XX% the observed. XX.X%. permit with all The evaluable rate a The very the with XX% lines Grade of Grade One along X+ X see resolved. At X.X CRS fludarabine, and XX for CAR that treated the patient however, X of to most good trials, patients, at patients days. from advanced in one XX% ASH those X.X two of were median we'll penta VGPR+ previously GvHD focus highest patients at experienced was was the treated Of therapy VGPR+, ASH of for set on all MRD response presentation, Grade in XXX million dose was X abstract, or dose highest efficacy median were million the to patients levels Patients were dosing.

in what look now like are to ASH lead remain the platform about that ALLO-XXX the rates. on update enthusiastic We to meaningful pleased CAR showed turn and differentiated would can and We our providing financial. response to call forward December. our an at maintain across our with treated over patients. from updated potential candidate the achieve myeloma for ALLO mean may We data multiple product data for patients T Eric I its UNIVERSAL

Eric Schmidt

$XXX.X for of which XXXX, We strong million third position cash, and million million stock-based million, $XX.X research includes the million afternoon. our in third expense. in quarter and a the $XX.X the compensation financial administrative good which stock-based includes compensation quarter equivalents cash with and and were In Rafael of in non-cash of XXXX, investments. expense. were General $XX.X development quarter you, Thank expenses non-cash expenses ended $XX

$XX.X non-cash third $XX.X compensation for of loss or expense XXXX million. per including net stock-based the quarter of $X.XX was Our million share,

research Forge While our the of our from continue CGMP at X on study enroll multiple studies, to clinical operational production and including detracted initiatives, a our and pivotal patients X we manufacturing into clinical ability hold has Cell ALLO-XXXA for potential support five preparation Phase deployment to facility.

stock-based million impact any continue activities. we open and be operational expense compensation $XXX to estimated we $XX full of the our your million call questions. to As year a that, result, expect for million. now and $XXX between $XX XXXX million expenses With to This development includes excludes will non-cash from

Operator

Thank Tyler The you. comes [Operator question from Instructions] first Buren Van from of the Cowen. line

Your open. is line now

Tyler Van Buren

very Thanks afternoon. for taking good question. guys the Hey much

has to the generate you could So samples you in the that ask, there what doing. ongoing that discussions, patient is from nature other might batch any manufacturing of that with And might to is the not, sample, you investigation testing the data FDA respect anything the to talk could comfortable, internal FDA. there the look produced more I whether have them? release the these or if like, be data you requested say things or if your perhaps with FDA formally state would about make the discussions that that's ongoing on that

David Chang

Tyler. afternoon. is Dave Hi Good Chang. This

me that Let question. take

the met of requirement. terms communication we informally have clinical received yes, related FDA's the data clinical to whether And we have of as a FDA well letter we details. as In received some that the concerns hold also, have discuss details to hold, a with

Also, concern single abnormalities in chromosomal made the So, what these to details, in there's the but team that extent, each abnormality between of that around each agency's clonal relevance. of expansion towards of we can about is this addressing of have terms which is any path a whether and there clinical our communicated, case other previously progress a of evidence we talk areas has whether is tremendous of chromosomal whether also the and has And a gene editing. concern. the a any relation making area terms than

details. point, while too what this investigations is and under are ongoing about, share. FDA are we that's to into review, talk willing still cannot the matter So, at much this we really the And

Tyler Van Buren

Thank you.

Operator

Jefferies. line question of Your Yee Michael comes next from

Your line is now open.

Unidentified Analyst

is this questions. for for Mike. Dennis Thanks Hi, taking the on

You of some give from number a chromosomal the Just TALENs changed on do you months And the you've out that the those the you. your in last much and the timelines back few investors abnormality, work FDA? the the any interactions given resolved. of sense timelines the could just call few two, next possible can hypotheses of it's How then forth terms outlined over be when Thank or from T-cell expansion. of a regarding this expect? done? on additional Has with you lay please whether

David Chang

terms is and collaborative and I interaction, a in interaction. very this FDA of that would Yes, say active

sort respond old informal had discussion well have letter. are of preparing as to as as we to ongoing the dialogue clinical We

positive. the So may this the different or happen. abnormalities. think about structure to extent, editing conference call, I published with literature couple of all of that very obviously hypothesis, how given laid chromosomal With Yes, this gene potential down previous we deletions to is in respect nucleus to

We is they expansion. that a but into go happen of as in also have known cells take in healthy possibility, chromosomal onto we to have T highlighted to that the abnormality we that patient also this detected kind

is our So basis possible ongoing investigation. the two explanation still those of

Operator

of Your Guggenheim. Michael Schmidt next question comes line to the from

Your line is open. now

Michael Schmidt

Hey guys, have questions. I two

investigation. go get study, materials for just a in what the around been Just wanted have clinical X to another process end regulatory said, heart is think here to I order be off to checked I Phase question. understand, to parallel to FDA. – to which ahead you go needs the the that submitted I side-by-side the the This guess, Phase of one X And is

David Chang

ask respond the discussions to been him I’ll Yes. to Phase your leading FDA, with end of Mike, question. has and X Rafael

Rafael Amado

has main obviously with the don’t we obviously Phase remained of FDA get into has also And and has manufacturing, all XXXA. trial is the can mean said, just included engaged extensive you also that. this X of And the not that, that, We discussions fully productively discussions, nature in and as trial, for the on us dedicated FDA. as type clinical Phase productive. which for in There XXX, been with discussions well is have regulatory matter But product co-development this tell taken all are sorry, development. those sell of to on is this field you as the X a been I details I quite policy, here our which a are Yes. with as have but the our both the of discussions whole spite place on David to important. very but as focus the sort discussions which activities interacting know, of clinical

So the would think doubly I further we’ve that, busy, the be as premature with than whole well would I But comment. it been say registration program. as to in

Michael Schmidt

I’m be not at that multiple on will a to ASH I much include whether And or on consolidation? great. share the study able Okay, will then myeloma additional how missed ALLO-XXX, patients data have might the have and question curious you’ll it, received but that

Rafael Amado

consolidation report and In will then next later, year. multiple myeloma, include we started will that not that

accumulated – that our few ability in responses to data type of have more longer well with or data terms of about was patients data. patients cutoff share and will MRD as been follow-up We some as additional a June, since in both the that

Michael Schmidt

Okay. Thank you.

Operator

Canaccord. Your line of comes Newman question from next John from the

now is line Your open.

John Newman

question. X the had taking a question the XXX. Phase about of for the study study I for thanks Also typical pivotal guys, Hi

that as patients be believe consolidation after would the would speaking, that optimal apply with that both response. dosing, as if in you be forward whether generally the the you and data dose, consolidation ASH, curious given disease initial a Just well that dosing stable we’ll would to additional seeing say way

Rafael Amado

that Hi, is this that for a It’s be I And consolidation that say going part that Yes. pretty But is as the PR I – from have well. doses encouraged early with say us definitive the is question of your would patients also this And the this about in data remarks, stable still Rafael. we disease to is you’ve CR. think as heard what dosing. we to prepared as encouraging to to are are conversion data.

additional additional at will And forward updating so follow-up. data look and with to ASH patients we

John Newman

Thank you.

Operator

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

now is line open. Your

Luca Issi

the Thanks Great. to for try much so I’ll question. not hold. clinical my the taking ask from questions

trial maybe a can that you choice for us believe pivotal to trial looks bi-specific CDXX be in dealer’s can head head versus chemotherapy Genmab arm? single similar settings. remind the So the just like started you has on trial, It pivotal why antibody CDX, pivotal a

for then know couple And if right that’s wondering do to we be dataset. what’s back. that wondering think on to take a comp their much. comments why on ASH, us but about data you maybe Thanks CRISPR weeks will I So from the competition not of obviously have so it. any seem your not at their

David Chang

study. a we the and FDA Okay. X Luca, X in thanks the as of and the about sure clinical pivotal asking We ahead for meeting design Phase communicate the upon and the the don’t want question make we Phase discussion our approach not question that hold, study once design. prepare to study clinical your finalize we FDA but go plan too preparation much of

in versus as controlled design. are study agency When reviewed could the the of think But bit to has given considered great live question enough in dose standard And an exact one. question evolving shows that’s it’s sort the data. over how I or of around consolidation. we around talk little precedents non-Hodgkin’s we a we outstanding improvement the set whether have lymphoma, the significant dodging the it’s I I data a regulatory not aspects. terms be in to FDA So the single I – care. not there and in a game question dodging, approach especially the going environment many what mean, ahead are single your question position, think because question but a a position, of about the a of the there around don’t that study, plus as it’s are we’re and a communicate certainly and arm know have

ways I So that of and that there be uncontrolled can our still of of can are that terms position from regulatory in a AlloCAR-T program, done stands review sort demonstration you precedents the efficacy believe think arm we many single the different our study.

Rafael Amado

focus really medical to multiple in the Certainly, our to other CRISPR continuing comment party’s think Luca, plenty need this the place support to just Obviously, And We obviously, on our space. entrance field competition data. welcome cell of is potential it’s therapy and and there’s allogeneic products. field not We makes competition. on stronger. optimize unmet on in the execute, class try and lead first our competition

Luca Issi

it. Thanks Got much. so

Operator

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

is now line open. Your

Salveen Richter

Good three? the then able regard for the my of out know you can dose on anything you just be four would helpful. comment, don’t secondly, level with versus plateau afternoon. to With there a been hitting question. data. this myeloma at rule Thanks whether if I you’ve thoughts And taking multiple point. investigation, to Are level dose dose here Any regard in terms response, to

David Chang

is this Salveen, Yes, David.

me the bit, to question follow Rafael. we and second We the but due know process. investigation pass I very active has to our very question quite first the a mean I’ll Let take want and productive. been

path With be Whether we’d mature the continuing Our ALLO-XXX, but to don’t – premature come million. forward. we letter the escalate. FDA. response XXX detail that is plateau think clear investigation do, done some present there with the I numbers to reach first to And clinical regards to generation and I perspective, million, and I any hold complete XXX of is main think XXX our particularly we is lifting out on path from intention pretty still see dose it have we audience the of we slightly have cells, responses multiple data million to is mean are I still about doses for we able what but We has hold, to and is. see higher myeloma, towards tell. the not, are will the position straightforward. to a been clinical the very or the until of our tell. mean, we’ll more With medium small where

XXX overall think answer and we dose I a at and then make analyze the as the stop Phase to decision X So probably million recommended is the will final will data what that be.

Salveen Richter

you. Thank

Operator

Your line of Jason from Bank next question of comes Gerberry from the America.

Your open. line is

Unidentified Analyst

the clinical I following kind – could FDA. the that risk you – holds. following response the guess, on that how question to the processing then pivotal second screening line of respond just they’re anticipate start once to the terms of to want on an for clinical just Parry Thanks of that the for in happen. of question. Do hold a guess, trials. to assuming is clinical letter this any type to, and you better resolution anticipate protocols could Jason. additional kind understand do the question, abnormalities you FDA, for long I chromosomal And you I our the when could restart This guess, the taking when of updates initiation trial

David Chang

asking some what believe our And that I don’t include we I matter, at question. resolution some the much. to point, questions. to clinical I question to generating we’re let mean, issues our questions Parry, to to are take me working going a to this additional related that is clinical focus mean, the letter. whole. of in And are we we are the have to Yes. very think much you for come response change important hard the data clinical setting of the do that the that in

for second And we long to it’s terms in what about the want are don’t FDA. to the of going take, how So, that’s doing. question I speak I mean,

very that defer to with add just by that to let’s just saying happens. going that us. when So discussion in I’m has engaged this But FDA been

Unidentified Analyst

you. Thank

Operator

Your next question Cory JPMorgan. from of the Kasimov from comes line

now Your open. line is

Cory Kasimov

the Good taking for for guys. Two as afternoon, well. Thanks questions. me

your there’s a seven question, disease evaluable having follow-up update all LBCL of curious to respond function valuable very in patients in patient study, to else? Is second on well cohort this is for consolidation something a I’m the one obviously of or four a some dose treatment. who today are same not with So limited terms first or then ALPHA response single patients follicular who baseline yet. And lymphoma.

that you to So or is learnings therapy? you. to Thank are why consolidation? as get goes take determine on initial market think be where what there this might a data from Or eventually can consolidation with you everybody allogeneic the patients how get to

David Chang

Yes.

me that question, Let take Cory.

in towards patients is large our preferentially So lymphoma because the the XXXA channelling lymphoma why reason study we’ve conservation are ALPHAX. the in patients first been follicular cell

we’ve CR at we – And are they ASH. repeat please? then XX% second rate. reported can will So And and update conversion you the to question CRS those of PRs the results

Cory Kasimov

Yes.

to In well patients some can therapy? having everyone that better consolidation? Is from kind single be a treatment, goes terms what consolidation you that, we learn why think get just who to this single versus of marketplace dose with eventually of the respond will

David Chang

it that improve Yes, terms autologous seeing with durability show in it’s and dose rate response may true for we’ve We hopefully as that more single beyond the provide an that And the looking that data just will we delta on those being dose provide able we with is the that on really of therapy. will we’re to increase reported ALPHA some second extensively patients and well can and study believe do ASH. what update in an at we’re patients.

once make be every we patient will So control. uniformly the in a decision, treated

Cory Kasimov

Thank you.

Operator

from comes William question line Blair. the next of Raju Your from Prasad

open. now is line Your

Raju Prasad

on to for question. Thanks separate your topics. get I want two thoughts taking

last the twice? transplant GSI consolidation – second and I’m for on on pertain kind kind when the to Thanks. eligible on therapy on are you TurboCAR you ZUMA-X data then And sorry, piggyback the about also usage and therapy. level Universal of line transform question kind using of that therapies, GSI there or that to In or of get wanted thinking consolidation First to thoughts ALLO-XXXA? get your how and the may trial

David Chang

Yes.

So the superior GSI of of study administration time has GSI. of

So it’s single is not ongoing. that And study a dose.

we we in the year We resume then on growing had and to We this the will that’s obviously. were XXX report next are already we listed, all to trial. again, making once growing were have hope we good started study. on that that that TurboCAR. – will really The whole progress And up experience. And report

whole. We continue to put patients following the

they GSI a additional So finite where there’s your of that trials. receiving with after essentially the see then time period And will question? point is

Raju Prasad

ZUMA-X to on your I line eligible in for potential data the patients. get transplant and ALLO in second patients wanted transform thoughts in just

David Chang

Yes.

the mean, surprise. moving lines autologous obviously of This obviously is a therapies. setting therapies the earlier not is I into are in this for patients. So great And

think those influence an have will on developing fantastic. were we they And end I up XXXA. how results

from have as pathway a follow been development as time relapse lines for the of time to will of plans gone. And patients, data product into clearly very of for but XXXA us refractory when encouraging well with is move on. We goes really the transform we full therapy earlier starting

Rafael Amado

we Now are certainly our we consolidation about talking I very lot and approach, data. just is mean, saying, emerging talking others, also peers by let as rationale an including after add, me there a consolidation, about started exciting of and good

that of of really technology. we in will consolidation, are especially it, – our other infusion way a I in depend CAR. programs single evidence-based, construct but on mean, what turbo So questions. the encouraged a do that we'll with to CAR turbo have is that mean, I approach key is novel by terms we the

So, matter. great this in step-by-step we stay but do questions a will tuned,

Operator

Your comes the Breidenbach Mark of next question Oppenheimer. from line from

now Your open. line is

Mark Breidenbach

of good questions. arrive before were consolidation dosing kind and related patients for I'm previous But some enroll holds what Thanks cohort, patients Hey, answer if This imposed, multi-pronged you'll have if to enroll the question. the your cohort wondering guess or prong you additional to I IGNITE which the already working taking the the even were enough to able afternoon. universal combination Thank strategy be potentially conclusion in in or you the before sort clinical is of these way the to nirogacestat and in study myeloma, really to one other. you make you. to of sort think best of any in have is from XXXX at studies as one you'll of able

Rafael Amado

that study are clinical a XXXX. in They ALLO-XXX, including Obviously, stop headwind us. what had our that of at the clinical for impact talking as point, this question. me open previously with let to the about communicated from CAR not data to will we halt take some IGNITE, timelines of you're we for flow the turbo we enrollment study, the as the of will I much ready the the the in was GSI. tumor study about, data talk solid have definitely Mark, well mean, the really combination

We the will is and timeline. hold data generation make same Obviously, our patients but clinical best keep the any the enrollment. we cannot timeline, attempt the to as I enroll expected, delaying mean,

Mark Breidenbach

Fair Thank enough. you. Okay.

Operator

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

is Your line open. now

Reni Benjamin

FDA? the it how comment to for I Hey, or guess kind any you that taking bookends on to long impact that there that the you just kind to here do of guys didn't David, discovered mentioned maybe on for how the And maybe you you FDA be learnings here you may of respond the think provide opportunity? But clinical take the joint might of the to one want afternoon any can venture, Eric, Thanks as guys. transferred I of hold the you or questions. could long good for is take? some learn to China automatically know Overland

Rafael Amado

Yes.

of question, lot terms people's first in central of that to that a In know is mind. the I

before on some question the be provide to a the on response will mean, hole. based respond. the to the to to around clinical clinical and timeline window FDA have they team's to But I long clock productively respond letter. we The We good hold shape how would resolution for I in assured response The the are is letter. when any hold. company a that act days. the for is clinical data the They the of XX – the working during which that they very provide additional producers to sponsor the clinical in there will hold to think I mean, does take generation, complete have not a pretty respond PDUFA

Eric Schmidt

Obviously, we'll our question interactions But on learnings Reni forward. the and with FDA phase infrastructure specific a from the no, our direct thanks joint to our do and venture everything and abnormality joint any to facility. out we're China. regard is still any that Overland timelines, don't China manufacturing apply Allogene, in well. Obviously, the And in including we think for investigation of is going building of quite I venture chromosomal on with the proceeding there impact

time appropriate use at to can groundwork be continue to we hopefully the ready to that an in So the time. and lay conduct future tech transfer

Reni Benjamin

taking Great. Thanks for the questions.

Operator

to Stifel. line question next comes of Benjamin Burnett Your the from

Your line open. is now

Unidentified Analyst

consolidated triggers Yes, a you can for us order second and dose? [indiscernible] ALLO-XXX On protocol This is dosing, to what Do to remind around on the need minimum the afternoon. patients second a Ben. dose? good in get response achieve

Rafael Amado

correct. that's Yes,

and some is to don't So the patient meet the dose, to second has on. dose the the ALLO-XXX they disease first get better dose, If also after go they prior get progress they us to they stable then also have or criteria. they second

Unidentified Analyst

you. Thank Great.

Operator

question Truist Your Goonewardene next from comes line Asthika the from of Securities.

line Your open. now is

Asthika Goonewardene

Hi guys. Thanks my to questions. as do taking two I'm for well. going

response we wait right the formally of the or bit academic you you, a We Just then question. whole and question too a [ph] process announced which that here? when maintain you adequate up And process? any correctly, Reni's out that do LBCL, give guys but to pressure regarding in window a the in CRISPR dose on tumor? little the figure plan happen consolidation to to deal maybe to long. follow ongoing particular folks to do address FTS did the noticed what part second on How submit the an maybe wondering on but going what announcing will that's letter you other the I'm

Thanks. So think really other out about approach rolling we as your to this tumor what's into figure that out? types,

David Chang

question strategy. Asthika, let disclosure first on the me take our

the think course intending activities providing timely updates but and suits well, with anyone that aren't by a meaningful in when interactions of do we're play a to Allogene honestly have to something we play to FDA. that give We committed day-to-day fashion and relevant of report. at I don't

tuned. stay So

Rafael Amado

do second And trying consolidation consolidation is the we for a scientific of without having to with based the give question, is give respect us, that question. chemotherapy to key to it on things to a are lymphodepletion. Yes, one with

cell now, well the after for our is in infusion. antibody cell XX I XXX, I right ability need both really too long cell between first expansion if giving as direction, anti-CDXX the second go chemotherapy. cells as consolidation belief So is that as is are we why when only and and mean, wait think will that the infusion a optimizes recover, well you days to given. And think which that patient's XX essentially use to I as we XXX want we kinetics, don't the our to

Asthika Goonewardene

question, Great. Thanks for taking my guys.

Operator

Raymond line the next of Your from to Leone comes Dane question James.

Your open. now line is

Dane Leone

Two for questions. the taking for you Thank me.

found do patient? that like single the be arm the around the the question, pivotal clarity potential it Thank second chromosomal contain ahead of a whether was would I'd you. a or have is, discussions in And infusion Firstly, you study design material into for arm, the any to in abnormality then control starting study? updated ALLO-XXXA, of batch would ask a study

David Chang

second me one. to take Rafael let and the ask the Dane, respond to Okay. question first I'll

of for hypothesis editing the believe making, reasonable terms this that could that is but say an be that gene In I a the question, when chromosomal nucleus employ we possible occur of at equally we can abnormality the is is expansion. occurred. natural that, from a this manufacturing phenomenon it's there but That's cells, that important frequency T undergo T-cells more when that of some AlloCAR

stop going So me we just the into there, giving, without too much this much of at know how let point. details

Rafael Amado

design, regards trials, the ones the myeloma. that the to off-the-shelf that mentioned same follow Yes. as have before, recent given most all And with the we're have one believe we products an will recent in based therapy [indiscernible] you fact most David the on including these in been know, with approved multiple trial both the path, advantages. the same single-arm We and particularly

with and products. So the to treat leukapheresis autologous patient differentiation and every ability the

belief this a be this at is So point that our trial. our and expectation will single-arm that

Operator

next Your Wainwright. line H.C. Robert question Burns comes from the of from

is open. line Your now

Unidentified Analyst

Robert. Hi, Mitchell Thank you for questions. this taking our on for is

approval postcard any can change anticipate pursuing? The is plans is in lifted? comment first development you faster you the a the there potentially Would on with key clinical that setting hold route question be after to

David Chang

Okay.

we finalize could that many obviously, design stand that we the of and in clinical allogeneic well details. as advance clinical of the of not we are careful studies terms a in study asking of go But how thinking before will designing changes we lot design in the fields kind of therapy. any by patients, into So questions safeguard terms to as we CAR-T do

Unidentified Analyst

the great. what versus you. XXXA Okay, have dataset in incremental at then could what expect the we presentation, And abstract? there data the and ASH Thank we see for can actual that we

Rafael Amado

that the of of to ability Yes, we think to it it’s the Congress. want the keep speak Congress. the until to confidentiality and present timelines sort the reserve of mean ahead I to hard I

So dodging stay tuned. the but apologies question, for

You’ll answer. the see

David Chang

now. And only from weeks four ASH it’s

Unidentified Analyst

very Thank Great. you much.

Operator

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

Your line is now open.

Kalpit Patel

even of larger number understand, for to what the may taking or designed Phase if Thanks cohort. afternoon. question. be were good you required for as single Hi, Thanks I’m to a trying you study for on planned separate simply two dosing into that both were more guess patients you implement Yes. the cohorts? to your and X a consolidation just and protocol. question. extra Maybe the need a ALLO-XXXA. if I Would just color it add greater if a total little was

David Chang

Yes.

regimen As before a in have single we the I mean define plan into study. how I details We the will going have we the said design, trial. this to

be plan So trial. a a a single and consolidation regimen have don’t arm to will single dose and dose single we

far go So with design. that’s to as can study regards we as

Operator

from line from SMBC. comes question Dai last Your the of David

Your line is now open.

David Dai

you taking The the further armory with triple share And type Hey the consolidation ALLO-XXX? therapy us improve question of also, combining trial? the for Are some of you GSK activity cytokine also your clinical us for ALLO-XXX cells? the using remind guys, are questions. the around using last Could to you’re for the thanks and you of CAR-T. toxic you with the could cell also,

David Chang

Yes.

potential gone degree generally are excited activity decide signaling too that CARs atrophic to damaging fewer potentially to we are these of These are expand that the able actually these many the So have cytokine anti-tumor about into the haven’t a to decision the be cytokines homeostasis to ourselves. and that made consolidation yet. study, We you be imagine it’s [indiscernible] use cells. greater so sees, these where And And exhaustion premature and specifics, that perhaps the details, it’s terms I doesn’t that need how that think tell to consolidation, to recover cytokines, after can whether are but not. going to not a kinds use lymphodepletion. of the one or is or may GSI of we’re in

a know We once the resume will it more trial. when we data we have little bit

David Dai

Thank so you much.

Operator

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

David Chang

the for again today. you Thank joining call

patient safety, to committed excuse deeply are We me.

confident allogeneic only therapies, bring our science deeply we easy, therapies field team are in our not as first work find the best We products. to not FDA with as forward are development way the to patients. committed the but the resolution of Developing patient a to to but safety best move and into CAR-T today, innovative the continuing CAR-T novel allogeneic we we field tomorrow lead it’s to that

now We boundaries and lead, revolutionize may you future to the take Operator, are proud of expand to immunotherapy. to cancer disconnect. the

Operator

you program and and may Ladies and off the you. today’s thank This Thank for now participation log your call. conference gentlemen, disconnect. have does conclude in you

Allogene Therapeutics (ALLO) 5 Nov 212021 Q3 Earnings call transcript