ALLO - Earnings call transcript Q2 2021 | Allogene Therapeutics, Inc.

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Operator

Hello, thank you for standing by, and welcome to Allogene Therapeutics Second Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. Cassiano. ahead. go Please

Christine Cassiano

and operator, on line. the Thank to Welcome. you, all

the to We today's as available one during that market provides limit financial press per and update for issued continue today, many After our Allogene closed on person, possible a to to release release get QX both questions will XXXX. webcast a press the are can so as website. and corporate hour. results we This

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

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

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

David Chang

tumors. to afternoon. first We in lead a therapies Revolution and patients Allogene the Thank with and delivering field closer bold off-the-shelf and Allogene therapy blood a quarter for cancers realizing AlloCAR-T both best-in-class of data treatment good step our our major of bring you us create cell have XXXX by the giant Three from first-in-class to cancer solid therapy. years a and and we program made lead for cell goal the To commercializing Christine, launched in second mission. later, one of as lead the Next

candidate a enter towards new phase the into non-Hodgkin's trial ALLO-XXXA XXXX. X lifecycle, in focus by lead stage a refractory we our our pivotal lymphoma turns of end relapsed As development advancing our for

initial forum profile path are ALLO-XXXA in in the CDXX confident we safety ASCO of June, increasingly Following efficacy forward. in and at presented May and data our and its

respects. holding that in the we pivotal Setting the the therapies. CDXX true principles allogeneic par and first efficacy XX% T studies, drawing the As learned relapsed-refractory from are graft on safety of deep a large of durability autologous cytokine XX% CDXX CAR-T patient that approved a and the rate comparison, the in trial of non-Hodgkin's our CAR-T we of are naive the of histology, of the during lymphoma development with which host shared profile trial pivotal are other patients CR safety is both responses from have with we bar limitations exceeded by the seeing initial the and of in autologous infusion ALPHA B-cell eye in release rate I that response autologous overall CDXX we trials with available ALLO-XXX with limited ALLO-XXXA are days in demonstrated encouraging. all the patients who show can and Meanwhile, of been responses, observed. XX% durable therapy. of population from syndrome forum, six-month the cause in involved clearly lymphoma, ALLO-XXX ALLO-XXXA safety responses or profile single and therapies and and FDA what achieve of an was CAR-T and rate key cross aside in therapies set from and have versus toxicities therapies dose the No ALLO-XXX profile limiting or data the our early our very CAR- disease CAR-T trial. also The CR

up Our trial, enrolled time ALLO-XXX be the our a enrolled trials progression, who autologous or weeks. enormous due And of of even have due therapy. to waiting start of cell patients to products XX% the within patients our manufacturing, patients while can five manufacturing rather median leukapheresis, failures. products. from than patients, XX% up therapies, to to to By who can receive within be in In treatment studies comparison the enrollment undergone nearly delivered unable ALPHA on guaranteed received in days was AlloCAR-T therapies CAR-T for to deploying worse to were disease receive days

remain preparation patients, for Top on that today benefit industry's the the we tremendous ALLO-XXXA bring the execution. first mind, can of focused Given allogeneic trial. highly our to is pivotal

look towards attributes update suitable patients therapies. of planning is CAR-T progresses, we clinical access treatment the allogeneic fourth CDXX can our quarter. providing the ensuring on forward time all program for this important the in to a we milestone Shortening to of nearly and how leverage the beginning our As just

to potentially our the aim look autologous the As of line beyond enhanced safety therapies. generation down of and that next efficacy our we is therapies, products

actively improve overcome to tumor solid microenvironment. the Our consistency enhance abate product working on ejection, new and research strategies is premature team cell potency,

behind of scenes. advanced Some TurboCAR-T technologies, these now approach progressing such our into clinical Others as nicely development. the are have

will first our Allogene, beginning product a So, it pivotal important our the new for of represent cycle. critically innovation while the represents initiation just of milestone trial

preparing to the also company potential commercial now a are transition from a We stage enterprise. for clinical

positioning, adoption, commercial to focus on maximizing which have We our build ensuring will team, access. and begun product

of experience President CEO in of expanding executives an the CAR-T Harvard at Vertex, molecular our and of of novel President launch an University Vicki, currently professor a bolstered at in oncology deep exceptional with the and including record several Vicki is of Board rare therapies, companies. of and former has autologous commercialization and We CEO have Directors. Liz, efforts and the Oncology one internal therapy. operational of biotechnology of former Novartis track cell biology practice leading execution our as and Barrett Liz with by UroGen appointment the Sato

vitally Later process allow of maintained be have launch we the us of days. this in new manufacturing us cell testing, commercial all we as that to and for AlloCAR-T patients potential month, analytical facility will host to scale greater X CAR-T to in key brings house California. York, heading be state-of-the-art prepare to to members in-house be facility optimize therapies, therapies The within to to event a we an important important our packaging, shelf From manufacturing, and Our at therapy production the to of our and allowing capabilities controlling patients. Forge faster, formulation, product, distribution cell therapies manufacturing available will Allogene, Cell first-in-class will off-the- cell the more ability deliver New steps which manufacturing. is reliably to Board intended beginning inaugurate

way have showcase is BCMA trials another tumors. technology nothing first our of the our bring tireless We goal CAR-T including and our as the our in bring our cutting-edge determination the yet from aggressively excellence five unforeseen patients. second allogeneic therapy challenges to thank ALPHA allogeneic program Cell gain manufacturing the this CDXX and facility at program excited the and are ALPHAX in team's The XXXX. ASCO presented at I solid data and two than them to by of advancing target presented phase convergence preparation in are cGMP platform half scientific one Positive a pipeline let X to in our candidates to to our more efforts forum currently confidence our before. clinical our operationalization TurboCAR manufacturing way. ever Forge one online for facility it X these global and that of on as we this CDXX of example We to with validate the and pandemic for incorporates build out rapid in to noted, Two facility. that including novel continue of

across Our strategic and is example able of to robust deliver meaningful multiple rapidly CAR-T. optimized approaches program myeloma A progress how been allogeneic we've to an multiple advance,

our myeloma. Universal clinical with Fast received we FDA our Beyond for multiple candidate, TurboCAR the and pleased US designation refractory trial, of were treatment relapsed Track ALLO-XXX patients ongoing that first

dosing phase patients of in that We are IGNITE X to study have excited ALLO-XXX. of announce we begun

We our to the confronting optimistic new for where also high set platform sights remain challenge. a rise have on to the of for We tumors is solid unquestionably the potential AlloCAR-T need our innovation.

Our this ALLO-XXX we evaluating year, clear trial our earlier and targets in initial traverse launched carcinoma. CDXX cell program renal cell

share we patients, to we As year. initial plan next data to continue treat

towards already translational on data the Over platform. therapies, across allowed to data promise the clinical of expect which X will continue optimize product to execution next the multiple of programs to and critical enhancing insights has Unwavering us of set our we provide months, increasing XX how have best largest generate we we our AlloCAR-T candidates. amount will deploy in to inform that an

a allogeneic date. to achieved focus have we by for reality what of team's making made proud therapy our on steadfast incredibly are We Only possible patients. CAR-T

to look the your also of this able often to allogeneic Rafael now in-depth is we define an we industry over more the being at While provides vision future important up and and continuing pace success. the privilege turn it for entails CAR-T are of activities. for to all leader call grateful are the we being challenge our development research in At to believe, as innovation, overcoming support parameters therapies and our the materialize. shape of for field will set I Allogene, obstacles,

Rafael Amado

David. Thank you,

focused our our have portfolio anticipate on increasingly AlloCAR-T might you As teams research of therapy. clinical and been advancing

response Across a naive lead longest across At track response on data last with our complete histology, look to XX on in track sign the response lymphoma at the X to of including XX% pivotal that histologies rate in in rate cut trial right the in lymphoma reported the was large ALPHA off, initiate the we are greater of follicular patients. lymphoma. we phase XX% trial, B-cell an the to CR complete time data non-Hodgkin's plans mentioned, overall whether all six ongoing CAR-T T-cell even lymphoma and forward exploring therapy both and David we for in for the of Review lymphoma. consolidation As and months as promise. a ALLO-XXXA that a use non-Hodgkin's ALLO-XXX a of are at rate months May demonstrated might XX%

Importantly, has ALLO-XXX. and study, allow a recognition given to the for were also use to population we domains our in ALLO-XXX to pivotal which demonstrate into eliminates efficacy intend in rituximab patient our ALLO-XXXA to safety comparable broader move that ALLO-XXXA, able

afforded to maximize levers our area we for consolidated find dosing. all is of the platform, allogeneic As of ways nature supports platform, us by lymphodepletion our which us look one distinction to to

also therapy, the off-the-shelf cell and we the therapy consolidation day, the our CDXX on of our initial regimen. unique During proprietary lymphodepletion attributes allogeneic data highlighted which leverages

of we study follow-up, plan CR. additional are conversion to of initial assigned. especially by consolidation Pending we encouraged consolidation our to and observed tolerability results, incorporate the pivotal We the highly into PR

autologous expansion for fully previously contrast, therapies, or the available persistence the CDXX approach currently our for the second lymphodepletion in is plan regimens advantages cell. depletion supplementing even investigate dose, and Q all to traditional an and therapies solving will allogeneic for first Our activity the dosing, dosing capable at second is allowing eliminate both consolidation to dose. on of is after not This BCMA one a agent we that In for important in the to portfolios. ALLO-XXX,

thanks therapy manufacturing the the We into X our the pioneering teams, to in of lead proceeding development been allogenic is of feedback the extend the interactions, end to have to first-hand involved cell tirelessly the are on including and the I have pivotal favorable know I finalizing activities registration currently and to and And collection my in trial of FDA. with of required intend our activities. XXXX. the multiple design initiate effort trials, X like ALLO-XXXA data proposed the working at clinical the trial we fortunate the pivotal complex portion first cancer and execution are trial therapeutics to would ALPHAX FDA towards discuss be extensive how in regulatory for much approvals involving and to been and plan preparation who for both currently to ALLO-XXX, Allogene us the development, of the phase of trial. phase the

AlloCAR-T to on program, based benefit resignation and ALLO-XXX and liquid tumors. The both CDXX broad patients our therapy. trial potential in have ALLO-XXX the targets Nirogacestat continues Regenerative provide need. with to course therapies on combination We're in enroll to be slaloming XXXX. medical Advanced we're UNIVERSAL Nirogacestat, further clinical the unmet from Therapeutics with dosing IGNITE spectrum of combination Medicine in anticipate to receive SpringWorks are in consolidation clinical of including Therapy, committed we're pleased were Although granted to a ALLO-XXX secretase with inhibitor trial across to advancing a universal FDA by data in we by the for updates patients share early trial and to We year We having on ALLO-XXX. ALLO-XXX patients also in arm gamma updated end of the with data monotherapy our to the thrilled from our and solid

stimulation. TurboCAR, immune clinical Our to signaling, of liquid on broader while eliminating first systemic their With our candidate in improve cytokine IBCMA our system therapy the the to and are key broader potential cells potency generation cell anticipate part strategy. performance next able traits induce being represents AlloCAR-T built-in delayed on administration tumors. for TurboCAR both cytokines and we exhaustion the that of our and to need solid TurboCAR with persistence

cell renal our dose venture progressing are in we Finally, Traverse in into trial, the first tumors with ALLO-XXX cell portion of solid clear carcinoma. the escalation

I'd echo thanking on present to year. ongoing like for expect We you to support. your next important and program David this data

consistent Our AlloCAR-T without of financials. teams for call to could to we a need, the promising candidates update of backing community. for Eric science on clinical in our and investment patients are something portfolio turn over the not progress I'd an in advancing like now the that making achieve

Eric Schmidt

afternoon. good and you Thank

to And Dr. remarks, Singapore. therapies announced made progress of Scientific development, the June, Shuyuan Pharmaceuticals Greater of and Korea highlight so I'd to CEO and Technology where develop therapy application. at he of Overland Taiwan, In and most Head of I Yao in experience venture Dr. Biopharm. AppTec, Chief China, in the of with the our was XX AlloCAR-T over acquisition, like Yao my South of our and portion appointment WuXi led joint in and therapies as prepared we commercialize open Research Officer has Advanced Development cell recently Allogene technology new WuXi and years Overland translation

expenses to in promise Asia. seeing translate Yao expenses We of includes compensation million his the XXXX, expense. expense. million the of $XX.X In development delighted administrative stock-based to and non-cash $XX.X we to the individuals presence quarter non-cash second for which million quarter were XXXX, our allogeneic includes cell compensation $XX.X $XX.X million, seek and were bring Dr. are meaningful team research activities cancer as of second of are welcome to and into of the already therapies which with stock-based General

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

the we million second any a trials a track implying at open towards This expenses includes million million stock-based and for activities. now looking compensation questions. will year. excludes of $XXX million, and of ALLO-XXXA to your the clinical With As We're pivotal we're trial to manufacturing development $XX during meaningful Rafael and the potential X, to non-cash ramp to of the XXXX expense five estimated operating $XXX mentioned, half impact David Newark business we on also call year-end. between facility. be from that, in $XX for support forward during including initiating expect our Overall, our XXXX, full-year continue initiation expenses to Cell Forge manufacturing an

Operator

from first Michael the [Operator Jefferies. comes line from of question Yee Instructions] Our

Your is open. line now

Unidentified Analyst

at on ASCO? is you us year-end. that staying around have Dennis quick a will set in just for data help type what seen data of kind Thank expectations for for to on coming the question Can we've what lymphoma just I This at we comment relative data get you. Can specifically consolidation? of you Mike.

David Chang

of will year-end. on of Hi, Officer, discussion, questions, to to I presenting at Chang. but take what ask Chief around much CDXX and this Rafael David to I data our going the be the be a expect today's is expectations usually I'm comment we lot of Medical

Rafael Amado

Sure.

we with the the that conversions have saw, we in XX% we were patients more at importantly, encouraged And we response. consolidation pretty CR. of received are and what out to some have XX patients of time seven by responding PR from point, ASCO So complete saw ten

up which that to gave actually to accrue rates, of investigators to to us durability. the may response be surrogate enthusiastic consolidation impetus longer very continue ability about boost So, a been and have complete

more So, end ASCO continued of follicular expect accrue and been well have those the and on ALPHA patients follow as lymphoma patients is both the and longer ALPHAX on as diffuse when may you year to that obviously towards include durability think, at will be large adjustment and the consolidation. cell as to least will ASCO, we obviously those will sufficient at make present patients merits of lymphoma, that I be there that up variable to the

can't continued obviously give at I ASCO, this but So volume an number, you shared we've be exact of what approach. it we will because more

Operator

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

line me Sachs. Salveen Goldman now Richter Your is from open. Pardon

your Please Your check line open. is mute button. now

Company. Frahm Our from Marc from & line next of Cowen question comes the

is line now open. Your

Marc Frahm

second And thanks expect going to just FDA you consolidation it to piece you're of durable pivotal out randomized Just about be think the using on Do going I early dose? that, rate of or for coming trial? of taking the you single that's of dose, for to and thoughts kind a of, consolidation data need is related Would difference defaulting the the might assumption. kind comments second minimum evaluate kind CR single-arm that the to see definitively a that on trial you guess, dosing default establish of your then require a to what's I my is to justify dose? of questions. guess in trial that your kind utility the latest you to the as that you

Rafael Amado

or think I to requires lead dosing fashion. product test sponsor regulators establishes the one gives a vaccine five or there very regimen year go cetera, the the until mandate general, with progression negotiations weeks Obviously is I than in et necessarily where from those dose every mean that dose just single or and to the of randomized for with questions. dose agencies, periodic the happen may fact good Frahm, happen, more product what Yes. regimen weeks doesn't dosing proposes that or to are forward. a to one that keen in the but a two a a need to the

and of like I or responses surrogates decide establish the expand residual question. not. better the rates, part It of some me more for CR more the evidence of So actually and on foresee don't dose. is before positive will is of to up mandate patients whether after the a there then of persistence we which accumulating consolidation a cells, minimum The leads some are and mentioned case, as to that composite to us to dose to and that the be of second whether also believe the your the months than high already be single the durability to would be we seen will the disease, continue which second we've I ability CAR and these observe us

pivotal we're excited that's a making to we're what we seeing far So trial, will our consolidation observe in that to we why prior will decision. about data but the it's that likely and incorporate believe continue

David Chang

if happen And out there have it, of in as that And study. go be and will on the this we kindly can forward and have design will exactly I I I will FDA Mark, lot is for we to will questions tuned clarify of we come the we the a certainly with think FDA you to Dave Chang, to stay add ask our pivotal what then discussion, that study about that, meeting.

Operator

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

open. Your line now is

Luca Issi

Maybe quick much a question on for the all one. and hanks taking so progress. my congrats

comment maybe I'm debate getting Therapeutics data CAR-T show cells you next CDXX CAR-NK versus I data weeks, a picture, Sage some think on thinking can the between the planning cells? to is for latest first are much. what's cells for bigger in expectations the on Thanks think into your I if what so and CAR-NK wondering that clinical your time

David Chang

for CAR-T now very you Thank question. Luca. pivotal into that program Certainly, focus allogeneic ALLO-XXXA really advancing the is Yes, our much our study.

we are We from experience are emerging dosing, XXX number understanding have consolidation data dose as the as coming we have in. well patients were most from very have single patients, the the interested coming which treated of and the we good of of number from, large the a

is know, the a active you very As field place. cell allogeneic therapy

of a that potential will in we see promise those durable I give provide the think believe the companies therapy the we their cells therapy and CAR-T and companies, with a especially in leveraging taking are lot leverages different therapy to off-the-shelf very approach, especially eagerly T deep the companies data responses cells what wait update. NK providing other and

have another conversation after I So data let's for believe August. is some planned which the in presentation, time

Operator

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

line Your now is open.

Salveen Richter

autologous two levers Could understanding you first see data you about program here with closer CDXX questions and optimization would here have bar you talk a to do clinical BCMA Just then, the profile? get what your as and CAR-T an of and the side, on here. to you required the

Rafael Amado

Salveen. Yes. Rafael. is This

on not through So can as and go and we have that the observe long treat CDXX begun you patients we to that know, ago them program has before dose escalation.

We that have into that is are pathway therapies, them and I of are angiogenesis come failed progressing think inhibitors point the directed step also inhibitors, treating patients study. many all

So, to show we evidence some year. that next we potential of get early hope can activity

targets In CARs of premature the thirdly partial very help we and solid patients tumors the needs in into et tumors responses I or markers will that be already think of we're more data that talk a of cetera. any trafficking looking follow refractory. is the closely. solid but but with as mature us also are still persistence think And to interest, to microenvironment these responses many I of with number And, you there bar, by it, know, will other and just progress, terms will about tumor surrogate field it's the at in complete effect,

dosing. of we terms optimization, continued In BCMA have

deal in follow We'll dose continue escalation. have were finished we patients. to know, the for, you we As

consolidation two we being to don't But, of you was the RMAT important the bridging features very for that in effect the see awarded in product very and to to that is ability are which setting. avoid are see the are autologous were and designation quickly starting clearly bar, well product, and treat has also get as We obviously recognition to the therapy, the the and the but glad that referred the just question that prepared use want to There started. a Nirogacestat to consolidation high closer we set that no with the TurboCAR bar. and still the continuing for remarks to cell pretty we in we've autologous so we

matter So, of these seeing on. it's thing on a optimizations what potential result

Operator

Our Securities. next question comes Michael from from Schmidt Guggenheim of the line

Your line is open. now

Unidentified Analyst

This interpret That's guess, is myeloma regimen? Michael. terms amount for there Kelsey meaningful building Nirogacestat our consolidation what multiple you. I expect combination. on Thank taking a you Maybe can be the side, agent for it we be Thanks should points of question. in would and patients the from see Will of on any me. we from consolidation that when initial the single to versus implemented we data get ASH

David Chang

Yes.

So started on this the recently. Kelsey consolidation relatively

more doses. patients, So effective There the be that may there but than we're already which follow-up be noted lower doses, follow will up. there long we've higher more not the will be on

more data, to really So as we patients patients XXXX probably Nirogacestat sufficient need and we like going but will NDA-X those are well, on type up NDA-X well treated so and we believe up. that have just will follow we XXX. have sufficient and and so will follow longer as

towards So we with XXX more much on will higher of mature present the will year. most be likely end that it doses the data

Operator

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

Your open. now line is

Jason Gerberry

questions. my for Thanks taking

secretase immature Obviously, a so think right shift dose were guys or a you programs or autologous dose the make feel last path or if the you do sort you mentioned ASH for set for your need dose mature ASH. point might TurboCAR at into curious focus curious, might just to XXX as the data at bar million be to consolidation, heading high to just you Thanks. year, to had gamma data whether question, cell or prioritization. not a whether forward that enough ASH pivot determine the single just be of is single or like you dose, BCMA Another to

David Chang

we set I and there BCMA lymphodepletion great different yes, I for different certainly beginning, can mean, CDXX you, test, right mean, Thank up asking our are stronger and I program question, questions. you're Jason, set way cell we the think the including slightly from we I in have higher developing technology. lot and best optimize generation consolidation TurboCAR tested all a the are benefits how ALLO-XXX. sort and ALLO-XXX the to step taken of knowledge have to program a utilize specifically these the thanks utilizes about somewhat different that the of than we the leveraging parameters the ALLO-XXX next concurrently and dose the all that Also, CDXX have levers levers program. more mean what that of we in we we up unusual

in a to So, though of making, these in about know in that we are of the program. believe and have we approaches pretty and what BCMA will for our to with the data will that we sometime about I in when terms path ongoing different take out patients we question XXXX BCMA good map generating informations got and that do position. the we are are to are all enrolling us different convergence trials that help all we

Operator

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

now is line Your open.

John Newman

initially question curious the in terms question. may two. taking Follow-up just give of combining the then with dose you're dose future. with to and for be Thanks I'm in Nirogacestat. last actually, to another that Yes, the doses on considering ALLO-XXX sometime maybe ALLO-XXX, ALLO-XXX wondering beneficial for of combination in or after and giving Nirogascestat if it multiple

something that's future. Thanks. considering for if the curious you're Just that

Rafael Amado

try that that benefit haven't good is intent Nirogacestat Rafael. just we're can tell to dosing I question. afford. to is into we can expression This I BCMA our don't give for we mean of Nirogacestat one competitive how Joe. Hi, dose Yes, gone but you reasons maximize and the obviously,

stay something So, of may currently the doses so exploration, this testing potential the is is tuned dose that for we take form and will the it several be results. and under

Operator

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

Your line is now open.

Mark Breidenbach

Thanks for taking my question.

to Just wondering But, me, development follicular continue on table have be B-cell the trial upcoming that off know one in will from focus now? plans of the the quick I'm if large main or a for ALLO-XXXA lymphoma lymphomas. I of is pivotal you

David Chang

this across Yes, Mark. lines a are of something team that studies cross mean various is comprehensive which is I a of suite program we well that now, histologies. as as includes right therapy

will we to As XXXA gone thinking of potentially other the really that follow a lot to lymphoma need right come trials in the and results very preparations activity along and to are up histology, with get second-line around we that histology that ALLO-XXXA so know, line there allogeneic would follicular focused on therapy form comprehensive and likewise on discussions and and be with about but that started, you are there are now, address follow a program. have third study

Operator

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

is open. line now Your

Reni Benjamin

the Thanks progress. congrats and the for on questions taking

have? are checkpoints the Just kitchen let's with when you development curious combination and guys to therapies as when you I'm remind indications are one I to why opposed just with can whether I about ALLO-XXX, of to in we with these the as evaluating tumors XXX RCC RCC say about other RCC, I think in us test in other combination from or of and think go me the cell allogeneic any it's where that always guys you solid guess any in checkpoints

David Chang

Ren, great question.

targeting coming as are going well carcinoma solid cell well as are using CDXX, you in and tumors where attractive ALLO-XXX inbound there antibody solid of of proof indications. cell is are some different both is indication, there tumors chose renal of the interest in tumor a the several of interest target, our and concept certainly earlier types with as Certainly, pointing a treatment lot also getting advancing CDXX why very we as to opportunities. are a heme and alone we as in from for As XXX out AML. is there renal to it other development of a AML lot

cell we the that So, many from corporate different been CAR-T reason wanted has opportunity we that's settings explored the have combine the And, an CAR-T a into therapy consider. CAR-T first in the CAR-T advance to we as tumor, part end there of a to I mean, perspective, chose I at solid is options your checkpoint the the renal is question, therapy definitely other mean, as which Allogeneic indication. that inhibitor. with well. as to

will treatment concept we get efficacy considering data and ALLO-XXX time, indications from proof we the be other advancing that also stay sort from program once We generates of that and tuned, ALLO-XXX, more single agent same well. the we will safety of as of be as the into at

Operator

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

Your line is now open.

Raju Prasad

that goes the for how CAR-Ts through Thanks. to transform it might the pivotal as Thanks I and its given thoughts results today. shown on his naive the taking landscape of thoughts time relates trial, ZUMA-X curious data B-cell hearing moving trial the by CAR-T therapy, change you've question. on to ALLO-XXX get earlier the your just lines wanted to into

David Chang

the both what one are in be was prepared we for CAR-T the Having CAR-T questions data of and statement, follow I Raju. out Thanks the bullish clear the ALLO-XXXA a for therapy about, that consistencies what I we allogeneic all study relapsed is the in and have are and lot think and opportunity are reasons the to just an question. CAR-T guess confident really preliminary certainly very ALLO-XXX in do, as to involved can of the the of there setting. of set line? was and is came to as mean future future the move be the lines collateral mean ZUMA-X to therapies I ZUMA-X the allogeneic saw with the that's we of are example CAR-T CAR-T. earlier that's work highlights therapy. ALLO-XXXA by for say that somewhat the and many start or allogeneic therapy, coming seeing effective a CAR-T about the and we the collateral therapy that more that that the can CAR-T earlier back not autologous XXXA the that it study see I I the what therapy personally of setting that been and I involved I going in in will said in autologous us relapsed-refractory so refractory what out better data in can therapy and

line Rafael especially to. that has other the earlier advance We will definitely in into alluded as indications, earlier

Operator

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

Your line is open. now

Dane Leone

later all Congrats me. the question to Hi, on year, thank forward the updates one progress for looking for questions. taking this of you the and some

that between wanted the that's that works the want infection here, now and question we you set of B-cell relative what clinical data how then data we One, design What recorded of year. if maybe you comment Thank see therapies be to could we and two, this go to play see could saw you're other milligram ASCO the with a a dose they higher focus Just in seem on for on patient now discussions lymphoma the forward the of that then your potentially inbound more FDA understand than for maybe to sorry. should to risk aggressive numbers around dose do regimen XX infection maybe bit infection on line salvage lymphodepletion patients. that maybe guess understanding into you. get about those that on And primary which XX not. right trial using terms for how in really expectations consolidation would terms regimen rates to consolidation with everyone your focused for profile. consolidation milligram ALLO-XXX, just multi-part relative the risk to or later that lastly, remind the in I

David Chang

I'll best do And this my and question Yes, objective. complex thanks a for is do question. to the

to milligrams And day three first that after we XX just XX, the upon doses you've give XX did that that milligrams same second then start intensity infusion, we dose the dose is and seen the in the which I'll milligrams. XX infusion. on with down is with consolidation, give So single the as

effects in USPI The that is autologous split of the products been it's the mid-XX% means dose the that XX. has incredibly that very mean, the infection in rates we good rates. the setting, Grade patients total between clear has do we ranges approved to the to down plus infection We've outpatient. the been we is that see we particularly two if is to quite fine. what the but doses. are So It terms at done point could three same which infection both infusion. consolidation, And tolerability the be the no There overall and or is hear I consolidation intensity XX% you of into X that see. similar class is of tolerability is been What see, really initial look the that and as with with an that's we're considering it pleased in it what whether really risk,

So the how do And believe a we're really of rate leading higher a of really not on we highlighted or that six infection. treat and that is a possible lead by the rates. even we wait than side. prophylaxes, feature, But these on and it rates patients this which something we is and even common with is guidelines way to really not to is to But been see. the your using dose, the see seven to that single split lower the that may dosing have what higher it's have

Rafael Amado

to And Dave, if can on just that. I add

infection some have of clinical rate. involved XXX over CAR-T, clinician this with allogeneic we have treated that those indicate therapy. for patients AlloCAR-T raised. that mean any higher the what is and have despite doesn't to understand been speaks I that concerns the been the across say data seen data who raised concerns infection point, than that have of and terms the I of a XXXA the in reported CAR-T some the we really in has But by that that at As itself rate infection as XXX rate been we in about and study. our and treated I now, AlloCAR-T, patients have has mean, think in I can programs XXX, have XXX different the been somebody I

Operator

question comes of Ben Burnett from next line Stifel. from the Our

Your line now open. is

Unidentified Analyst

Thank is for the Catherina Ben. This you on questions. for

CAR your what For to ALLO-XXX, how by points program and time cell data? solid of think be we tumor biopsy expect tissue supported data should can with expansion we

David Chang

seek then XXX the data until we goes of that to but XXX in cell early that expansion premature T-cells. persistence, out There and is way same cell But with one the beyond. So, we've haven't obviously feature six to mentioned stated we we cell yet. it and continue we our on, in is of and follow closely we've which although our as obviously follow in But expressed months way is XXX is we the seen past, programs, expansion. share any we've out activated or which pretty rest time on not see cell to doing expansion in

to we the actually cells. reactive believe ALLO express CDXX by be may bearing may susceptible killed CAR So the and T-cells cell allogeneic that

So, persistence and very are it a taking that actually we is this look looking closely. is something may and be possible that the at even superior

to do tissue So, we in in in terms very definitely tissue, of don't biopsies want this see we migration the of tissue the I to and the happening what's on. cells CAR particularly positive early the XX entry happening PD-LX look for and other presence, study tell for CDXX, us look we to within then CAR tumor we days, into obviously with the what's markers microenvironment. first PD-X, the and

will will are the the results but of these he far into and presented be we what be accumulating So are data part premature, diameters.

Rafael Amado

tuned. stay So,

Operator

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

Your line is now open.

Asthika Goonewardene

inhibitor. follow still two rationale bit that, putting part this when back you expect Just more that and persist and might to response mention soluble et other a the granularity up related see size I ALLO-XXX cetera. want if combination XXXX in could early see that these you to Pretty, to on is very And you place much. together? for going What check BCMA little you to measurements state plus, as we of look to rates just the the will give MRD and can in in support first I level then early levels, help Thank want you're if here. did the maybe not, that data guess

David Chang

data I when a think, make XXXX the I and once shown. data at we we will Yes, this will I mean that haven't we we be said will have be exactly consider said we mean, meaningful set. it decision

the a So update. say, stay continues actually very tuned. brief that two team is All on running approval these and is problem, excellent a not can I execution been

looking result that's bone relapses you. important reason is and outside persistence, for I most of that possible a the at right as better is to which in-house increase factors soluble at the ability we're and looking we're and as CAR-T soon field is we're activity focused in what to we're the than the obviously, data all this we expression of we'll in share ALLO-XXX at but the see biomarkers in in plasma doing mechanistic the able marrow. looking the cells, that mean, accumulate Nirogacestat, and disease mentioned. BCMA MRD, we're important meaningful But, actually the BCMA be you prevent which something perhaps hopefully, looking So, we're at BCMA, that extramedullary Yes, on, giving looking we're with also

Operator

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

is line now Your open.

Kalpit Patel

remind of the cell, one taking doses But, same for expect your thanks using to the you on in study renal tumor you're priority obviously question. us safety the Maybe for are or in is we PK-PD trials. the first. renal then, those hi, lymphodepleting signals based for modeling. should David see preclinical Yes, some activity at Rafael level what your in you Thanks. clinical use what that liquid And can the as if essentially cells

David Chang

let learn not those preclinical clinical, the question. as in to me it cell dose that all From the CAR-T we field, Yes, is predictable.

clinical currently in see really in is has So, which being done what in clinics, done. to study, to planned mean, of I be carefully terms it is

it in I in the tuned, stay I or plan levels first second, dose the dose happen happen study. it XXX mean level three the could could So is in dose the mean

The question… second

Kalpit Patel

of… administration The

David Chang

The the tumor malignancies. for heme lymphodepletion solid versus

answering not different I the for For apologize question. reasons,

on to silent making. strategy are We are that we trying remain lymphodepletion the relatively

in in we expect occur XXX So, just presentation XXXX we've year. data to the presentation and prepared as data for said wait the statement, next

Operator

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

David Chang

cell two to commercialization, as for Allogene Operator, our With look us X, of future first manufacturing first trial events initiation disconnect. begin that Allogeneic near-term control journey It's in the joining our you. to part time of of we now for you world-class today with you that, pivotal taking taking and ahead journey our facility. define exciting Thank our therapy. Cell an Forge thank for the may the planned and towards

Operator

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

Allogene Therapeutics (ALLO) 5 Aug 212021 Q2 Earnings call transcript