ALLO - Earnings call transcript Q4 2021 | Allogene Therapeutics, Inc.

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Operator

Hello and thank you for standing by, and welcome to Allogene Therapeutics Fourth Quarter and Year End 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] Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. ahead. go please Cassiano,

Christine Cassiano

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

of and Research today and Chief the our Development Chief me call are Executive Moore, Dr. Alison Vice Chang, Schmidt, Amado, on Technical call, quarterly Medical President Officer; Executive a Chief Officer. President and Dr. and on Eric Officer; Rafael Joining David Dr. Chief new Dr. voice Officer; Financial

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

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

David Chang

pivotal clinical X concept. year to was of program allogeneic talk our we non-Hodgkin's our in with all to programs, program, our an potential proof in challenge you our With Allogene cell what unexpected fields solid Allogene, from thank CDXX and a in the am associated first joined with promise tumor of pivotal to working lymphoma, our field we program initiating for patients meaningful trial and our advancing excited role have trials first multiple important are alternatives exciting both and therapies advance significant to who Christine, therapy both you, T we provide in a Thank moving clinical will about myeloma as non-Hodgkin’s be the and year our from CAR progressing I for played safe and mid-stage very continued readiness of lymphoma. which hold, Phase three believe a XXXX durable ALPHA of an to autologous forward. the call. achievement as relapsed/refractory data to our clinical and demonstrated to pipeline of important approve ability platform to support our

leading CAR Our multiple next most a allogeneic advanced in T myeloma. is program clinical BCMA program targeting

as CAR Our door opened still in this universal trial concept setting. the for demonstrate modality, T disease study for of proof allogeneic only the to this first substantive and

patients products can access. in might patients two of XX% be in to products. concept, data to to limitations of chemotherapy. we still of about a to are they treatment constrained patients card compelling wait are time progression deliver AlloCAR CAR even underwent suitable we proper they By by how products potential delays, AlloCAR therapy the therapy. supply just the days myeloma therapies is cannot to to trials a manufacturing receive be, for we manufacturing matter their and the are excited to require as who proud for unable more disease who braces within of treatments and exactly of Treatment are weeks. efficacy autologous than patients for to autologous receive T products, non-Hodgkin's enrolled No Patients products. enrolled studies within T be failures. lymphoma, value for patients leveraging critical and many who was how start within no often to autologous not rather as treatment In for comparison, tolerate access who therapies. our for from ALPHA days products and have to T breathing XX% in for up our While look multiple candidates our autologous time treatments delays more Today's to marketplace beginning the bridging deploying AlloCAR-T even the due disease gain and waiting five nearly of established that enrollment for the is With receive CAR therapies treatment. patients of patients ability progressing for trials therapy requirement of unable effective on of autologous the may limitations, autologous shown while median cell guaranteed safety lymphoma Shortening are inherent ensuring to the myeloma, with chemotherapy overcome nearly both attributes to the cells receive the are in to of all those cells, manufacturing setting data enable we successful T have the many our considered

candidates product Our the beginning innovation field AlloCAR-T. the first of allogeneic in of are only

enhance aiming products safety next based technologies the and turbo CAR generation Our of cell on allogeneic and to efficacy other our that therapies.

in our clinical Aside hold. payment from unexpected the challenge data XXXX, presented

will therapy. that a investigation of We wants the be edge reconfirm products. innovation, under and competitive depth the the to quality of forward look the the Rafael which the and close responding cell field allogeneic the While the we AlloCAR-T. forum. us pioneer the no look provided I with situation be from field to results employees to sharing leadership, believe proud peer quality of incredibly team, quickly this a processes company to a demonstrated our we to this us to in whole a lead opportunity our scientific the reviewed to retrospect, the as manner challenge. our resolving and stewardship us retest of In with am provided focus of give our required in insight faced manufacturing experience In whole, in our of collaboration,

large in May stage our in Pivotal for next lifecycle the B with relapsed ALLO-XXXa lymphoma for plan prepare we cell a XXXX. As refractory trial

that sciences to also From are to technical our photos create license of the delays minimize brings beginning, in submission. off at delivery area. that operations, to reliably, time and maintained manufacturing a could scale. of house we more the have we manufacturing have determined controlling organization. is shelf and the at faster, us This And the heavily T this greater a having product biologic capabilities application We therapies CAR in invested key

is manufacturing of operational study. facility New of the California, fully supplying called Forge plan now Our producing in Cell GMP pivotal and X material state intent with the XXXa, art our York,

we Allogene, I is person there Alison forming wanted knew no Dr. operations are Officer. team by XXXX, was as been that the Moore. before, is you Alison incredible technical something Our led has as built Chief I never building blueprint. Technical In our early are When

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priorities to to invite for call excited her like today. to R&D now would We our Raphael the preview the are upcoming year. I join have

Rafael Amado

you. Thank

a focus on and today year CDXX advanced As the pivotal would targeting my to like on David, BCMA programs and ahead clinical has trial noted, programs. our prepare as remarks I CDXX for we

immunoglobulin clinical ALLO-XXXA. abnormality The sell treated other T editing a trials. AlloCAR single XX, product that on press manufacturing a that aware, rearrangement abnormality D or removed manufacture as part our most clinical the administer it in gene abnormality cell none AlloCAR we other release undergo of As T are receptor to ALLO-XXXA gene same cell regions The challenge clinical in January or was any in determined had the of the process. developed in unrelated after patient cell extensive chromosomal our maturation significance. had detected process hole any no with a and was the issued and investigation, announcing genes not detected on the FDA T After with or was both treated was patients T product to the and

study our was many robust, engagement study. During and was our anxious were investigators into whole, recent with for Allogene clear it

focus quickly carcinoma. and and enrolling ALLO-XXX pleased to and our are We productivities patients per for ALLO-XXX cell myeloma, have renal resumed multiple are ALLO-XXX clinical on

the completed the XXXAlpha now have in accrual up. term Alo and will continue study to study, We follow assess patient longer

we directing XXXX on to plan to starting start phase be enrollment the the and need. study the our FDA, to focus to of in patients order will to we with offer approach X, such, in registration resume in Phase X to ALLO-XXXA study. outside Prior finalize the T AlloCAR As prior our the pivotal

track product. to to the first Our Allogene deliver mid remain year. trial ultimate ALLO-XXXA is We our pivotal on start CAR goal T approved

asked investors commonly trial most questions the One of pivotal about is design. from

of are nature field, finalization competitive the of FDA. the our the discussions we Given the with prioritizing

study additional time needed T potential patient and need of differentiated BLA submission. enhanced Antibody pivotal be the initiation. discuss what loading share candidate. requirements trial a We of that details regimen ALLO-XXX the single of with would many single use will expansion is of evolving enable ahead We AlloCAR the will front arm in ALLO-XXXA. trial arm Separately, we're Monoclonal activities from at or our the believe persistence Alison and for to for address intended as XXXA through Separate our anti-CDXX CGMP our of

presented ALLO-XXXA highly of for competitive trial registrational pivotal at on demonstrate its and contribution large we T the to These to lymphoma. safety have randomized to cell previously with intend the enables ALLO-XXX conferences. trials of medical product of launch the ALLO-XXX overall also lymphodepletion Based for the as believe the We regimen. profile trial. the It We the patients Expand time the benefit data at standalone referred ALLO-XXX intended to trial. a

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XXXX. can of has from dose a BCMA allogeneic Findings and end and therapy activity indicate delivered all clinical inducing So plan ALLO-XXX multiple a resumed therapy felt deep Trial to by provide to T that updates that we capable CAR and our the UNIVERSAL be rapidly, therapy program the of we myeloma single response. for of patients with was refractory bridging need on

ALLO-XXX are the response responses. meaningful The patients a options with for margin relapsed maintain benefits allowable and disease more achieving emphasize high or is with approved potential VGPR as new ample T an benefits often alternative. of my they MRD valuable the to similar of by discussions therapy We for autologous monotherapy by especially an clear, are pleased could therapy even like allogeneic for better the negativity CAR offset refractory achieve with need that a provided the of investigators, efficacy rate horizon. therapies multiple in option rate, aggressive or myeloma, that Through official in is

only of anti-tumor have survival challenge less clear call the of challenges signals advanced and cancer X T renal to selectivity, inhibitory the summarized our advanced working scientific AlloCAR in within or briefly technical microenvironment. AlloCAR necessity carcinoma. with with XX%. regardless unmet The CAR like approaches tumours, for underscores necessary generation Alison target would I several to of year can welcome Clinical ALLO-XXX our needs trafficking data the solid platform, including over for This I T our to trial. We're is Metastatic be Trial T overcome discuss or ALLO-XXX candidate with to have recognition the rate next would Meanwhile, significant been generating cell the therapies look tolerability I historically forward traverse tumours issues three of innovation. Alison. solid tumour dose our like development escalation turn patients efficacy the modality. on than which to to now areas: not kidney clinical trial to ongoing but resumed from is patients have a in comment five and faced evaluate survival designed for cell for the these in Phase in and treatment tumour. tumors. overcome also X to we solid anti-CDXX which Before our operations, Phase general activities safety,

Alison Moore

high you, market, of Thank I've to career my bring redefine facilities, build the State-of-the-art performing Rafael. manufacturing to been teams, process development. build multiple fortunate scope medicines and in

I products we've shelf a in and small off reality T-cells the been of never something before, made were am When done had do highlight in CAR-T most joined patients Allogene been from AlloCAR of the something we cancer career has healthy T progress a that with for However, to the a making patience. I XXXX, team working donors. for proud creating

solving, excited effective our from of complex allogeneic development, to concept the getting I've have antibodies, to advancing convergence initial modalities, design of cell quality lives. we've of CMC problem is represented I'm It and proof paramount is provided solve together how world development quality simple into many our and clinical industry, work, potential most safe patients of In coming worked excellent been some the therapies. is and translate cell seen first of the the monoclonal improve creativity, to difficult delays It on disciplines the not Our rigorous manufacturing bispecific, that XXXX issues critical. why our but so challenges. presentation product biopharmaceutical products. multiple two or product products therapy, Understanding data of again time That time to and in particularly science fortunate is is showing viruses collaboration. patients and far in for control increasingly including of years and have treatment. about

While reproducibility toward following the is field, submission for of have science, process to the and an CMC pioneers, the of and evolution may the the In the methods for opportunity difference the we years clear. these product, privilege is be we produce of cannot hope become stand teams weaknesses optimize cell evolve right of for common between could patients expedited Any requirements development compromise dramatically In increasingly continues need. The raw the the new a and the is or and study This gaps from performance the for importance. in entire the ability monoclonal afterthought. evolving critical BLA as timeline our quality the industry on Failure FDA for cause field delay work and utmost of landscape game a production. X therapy for reality in during is late-stage and approvals. X potential our the and pivotal regulators to patients. complex the to autologous to Phase control The antibodies, and In materials have sophisticated. of is relatively which product products emerging process therapy starting teams the of be It submission. pitfall ensuring effective can the of the CAR-T safe for instance, recognition that gene biologic shoulders demonstrating a strategy. understand the and and the clinical can CMC development quickly, cancer, development of Phase product and unique within practitioners, candidates we trials experience the changing have

product the a many product T more that proud is prior long-term and moving At patients timeline able robust to we ahead dossier the building strong approval. as now well-characterized approval am the our important and development being will variability. risks advancing the and this to to to forward the of a I downstream call set We program. Strong execution and proactive our the the products. clinical, sciences, promise so confidence we work this exciting, potential ability is believe process focused of start design drug Allogene, incredible across and research, of on up to be improves with process of Understanding CMC to characterization our development, to safely effectively by important to are will importantly, mitigating work can biologic the trial effectively pivotal collaboration done any pivotal the for including say our ALLO CMC We our look strategic support of measurement our of I success. submission in minimized robust for live with the delay work CAR deliver for eliminate to look and validation biometrics. that by advantage start area regulatory translational up turn quality attributes of to the and deliver enables us and disciplines, the While Eric. ultimate validation communicates VLA This team activities. over goal. we requires a

Eric Schmidt

Thank you, Alison.

manufacturing therapy a gene During get often evolving multitude meetings CMC of investors, and questions we with on cell the and landscape.

visionary an privileged have So someone quite technology to experienced we're so at helm of operations Alison Group. our the and

challenging market year a few I quarter, of industry financial cash cash in equivalents to the very strong We and been in with minutes fortunate of forefront and be $XXX position stays that's the investments a end, I'd Before at environment, a to topic runway. cash, overview debt. for brief no our very and a financials and the like provide ending year spend million the on were

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year associated we review research stock full with expenses compensation. expenses our the for based financials which development and million $XXX.X $XX.X million, As in of for XXXX XXXX, includes were non-cash

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net our full was the per for we of non-cash your XXXX, questions. will million. For loss open compensation of expense million now call stock-based the $XXX.X $X.XX year share, $XX.X or that, including With

Operator

[Operator Our with Michael Thank from Jefferies. question Instructions] first comes Yee you.

Your line open. is

Michael Yee

We other will competitive and update. CMC insights have manufacturing. can you what for too provide giving will real the you're maybe what call Thank generation, that's that away us expectations, first you're you without you a what this on I us could two to there's all Maybe key myeloma confidence and and advantage competitively much Can to for light And on give about that data TurboCAR? on you In on on start you remind data questions. later just appreciating some that words, shed color not CDXX us commenting on that. advantage Hey, update. or Thanks thanks had all the working you. by and this year, mostly likely you but some relates around study of have guys. the on the the discussed are was presumably, One the guess second the those color pivotal factors. mid-year?

David Chang

complex. head question, earnings for done previous in something the tip level provide not that much our probably about this this questions those I'll questions. very that's too don't And side. her to revealing want ask that Hey what's being CMC is Michael, Alison? response an two spoken is Alison we also, since we Thanks joined about has And our on much. the have call. CMC But area David. is -- head of high to in, some to your about

Alison Moore

on side, as we think product that supply Cell really product It Thanks are X. excited helps Also, advance way really X allows Thankst well. that support excited, provide development. comments, was is Cell that to are can my as to support we to excited Forge me Forge to are go modifications, so realize best the this we understand from colleagues. towards designed we Cell it with CMC goals I David described and interested and the that agency commercial helps and for X. material. in it obviously, Michael. generating through Yes, our from And we And Forge the supply built make all working our already refinements are our we're and the optimizations, that We ensure of demonstrate GMP clinical really really BLA filing. to and us

Michael Yee

big support on Thank Cell you. really then kind Forge of it's that myeloma? like X, a that's commercialization. that’s -- part It And given of this sounds about

David Chang

Yes.

mean, Alison trying ahead front filings. I load to of are as on that, activity the had said, we much just So, BLA CMC as

the measures taking in the study of to launch up things are that And is address do. the as from being may well with line. So, trying potential pivotal we big known come materials are CF to able to what's X issues coming that very as the the careful we down one

myeloma the on Raphael. that with data, So,

Rafael Amado

Yes. Thanks, Mike.

continue may there to these The and follow-up thing that's durability. the as responses durability is so I about to how we the well excited terms in And were remarks, And that the ASH VGPR+ compares as XX data. and still out we about in so follow-up approved spoke product how of was patients the well actually it improve. did you interesting we as know, really at data on long, patients, presented not my very

in by that product. the really about received a terms fact that been results with to patient essentially the both in the virtually treat key non-investigator well opinion able are that really every product is as of and opposed We investigators leaders it's obtained autologous to excited are

forward And include update, of the an patients end mentioned would we we year. be with to I it nirogacestat. So providing look the that the before, that as would treated towards

We and treating towards wholly are with number we of patients now the all from some through to patients end of patients follow-up, ALLO-XXX, depending may include able of those on the be the of and update year. the in the that

So stay that and really It's a exciting program will year. a for big we us are be point several it approaches, tuned. testing decision this

Michael Yee

Thank you.

Operator

you. Thank

Our Richter with next Goldman Sachs. Salveen question comes from

line is open. Your

Salveen Richter

that secondly, kind Good speak ALPHAX the to forward? to have you for how is my here prior step discussions to you're having finalized with ongoing trial? And be then afternoon. should to Could CDXX about that positive move question. commencing program, to be a Thanks with the to that what the FDA pivotal we taking for the to you'd see of want what for think then the bar just

David Chang

both can you're to to refer, my job those questions. easy. Rafael Salveen, making again answer I Rafael? of

Rafael Amado

Yes.

of having know, as think -- mutual program and obviously lot speaks in FDA agency But as be to the to the So requires approved we for allogeneic we we've I which to evidence how as terms of ALLO-XXX in well been a develop precision co-developing product. vessel co-development, on the during lymphodepletion. interest you forward. as with us fall, had gives of it moving with And have order benefit well, -- discussions that risks. so, XXX this And interest discussions

those So discussions being are finalized.

by the will And study ALLO-XXX confident on the We’re follow very are actually by advanced the shortly quite we trials. start study XXXA will that start them. mid-year

CMC both we obviously, together So our complete working trial. trial without to any ensure ability And we very to in Alison jeopardize sync team and to design execution to closely mode. may and that regard in going work her trials finish this with to be that with any regards the with or issues are that issues we are

So But on stay mid-year. our have to confidence to discussions by plan, tuned. we proceeding and start are the ability according full

resumed, and solid cell program, as it’s exciting in lot to said before, and a we inhibitors of even as quite if malignancies. There's you low community tumors of more one survival And investigator of the but I and tried order we're patients continuing potential and with fail unfortunately, these they they CDXX therapy it's carcinoma program the program, the On program, once about check-point now. started angiogenesis XX%, know, hematologic really XX%. is CDXX regards treating other patients bar has renal their excitement the inhibitors, get had in it's than this got line in

with But really But So, response release they the are will obviously, very we meaningful be approval. is evaluate is it’s work. threshold to with it. rates to regulatory this regards would for stopping investigators it's what be something happy therapies, because us the have see for early clearly, after discussions it that a that patients obviously, will, we as much

the tell. little to it's have program to we bit be little a those we So, discussions a able bit more, in will know first, for early us

Salveen Richter

Thank you.

Operator

Thank you.

with Cowen. comes Buren Van from next Our Tyler question

open. is line Your

Tyler Van Buren

Hey, on specifics required guys it's trial adding trials thanks purpose the for what should to taking for allow to the questions. question needs is, And you approval? provide more separate safety, beyond much you guys, to ALLO-XXX registrational then detail be it Related demonstrated this comprehensively endpoints the very theoretical approval, of to second demonstrate safety right? if So, the could the safety be significant for other a historical the regimen, your than beneficial is infections, of profile concerns eyes? any given in which and events the AlloCAR-T can

David Chang

XXX the it a is the precision before, in in for we avoidance required know with incredible said projection. of regards XXX, advantage. as allogeneic settings the which ablation is view critical A as competitive T-cell depletion, provided so Yes, allogeneic to has we us space, with you and

in been each So, involved but demonstrated the shown components, one the co-development drugs, and and be of development the for both of including XXXA. drugs because co-development it's XXX and requires many to I've risks FDA benefit

a for just randomized but be is a that better that's it well. And need program. hasn’t doses trial, to our to program, not hence XXX [ph], it's pretty second And the program XXX It in been FC – we shown So to suppression component in other study in outcomes. our as they that confident studied been leads going the at multiple will compare required. has are is

we So the regards autologous with this a that confident comparable setting. importantly going it used superiority is what show is show study actually alone. the FC that's we're to safety in to And to of very to XXX very see

you're absolutely right. So

demonstrate or alone XX autologous CAR a and seen to with also XX FDA with expect that the par is T. of superior We what's on tolerability FDA to

Operator

Thank you.

next from comes Michael question Guggenheim Securities. Our from Schmidt

Your now open. line is

Unidentified Analyst

Kelsey This you a advancing I consider before making XXX? one data thing question. dataset on update guess, secondly be Phase BCMA, I Thanks on Michael. for Hey. you confirm will is guess will to you. go on CDXX for forward ALLO-XXX to there X then any both ready And would or taking program? to decision just and the my see for franchise, the Thank XXX

Alison Moore

your ask to Hi. Kelsey. Eric. questions. to of to I'm respond going Eric both

Eric Schmidt

Kelsey. Thanks,

study. monitor ASH forum that we set, a present complete the that achieved expect continue dosed to of show durability In a terms CDXX able as don't who patients of in data response, previously that we've data XX the to can medical and follow-up patients reminder, that really will off, the But a been updates, pleased have some the exactly future longer a observe as been complete particular been cut have meeting out with in at see just as response. that yes, term you we yet. XX know in for to We the still gratifying

those by program year, And how just to nice generating of we're hopefully data be mentioned, critical end of strategies. to is yes, enough the already XXXX think to our many we we'll datasets across multi BCMA the to year question now as have can Rafael to program. see pronged a for steps. program the a It's to decision on in clinic be our And longer your this last. begin next make our going second responses So of has much ability the across And evaluation back keen with back in execute strategy. the control

Unidentified Analyst

Thank Got it. you.

Operator

you. Thank

question comes Breidenbach Oppenheimer. Mark from Our next with

now is open. Your line

Mark Breidenbach

Hi question. wouldn't you much guy. design. study tell about pivotal for afternoon. the you my Thanks But us try Good I you I'll know said, wouldn't taking anyway.

CRS, endpoint if ALPHAX. just CRA the and And Lymphoma kind given wondering currently a approvals or I'm trial recent model as a Thank have that in ORR you're after. seen the serve B this potential of point can you've wondering cell likely precedents that viewing study. registrational to between I'm any so, or if an Just as Large if cell the might that you. closeness build B you in

Alison Moore

Mark, me on take Hey, question. let that

the ALLO-XXXA is said, as is the rate has proceeding study measure and then single-arm second one that's pivotal Rafael the or as of elements to the efficacy So, any response durability a single-arm response two And important study in rate. response. objective

is another efficacy So, certainly, and also in discussion expect data endpoint primary has of been that key be to which CO-primary of the expect two of review. – weigh the those FDA. be that safety be part part, measures part I with and we will And will the

Michael Schmidt

question. Thanks super Okay, the taking helpful. for

Operator

Benjamin Securities. from comes next question Reni JMP with Our

open. is line Your

Reni Benjamin

status a as guys. so reason, application And, something And track or how this, good that just is thinking keep going pretty sure know, you more is Hey, if striking well, joint [ph] year, new that on collaboration and used might then can So One a we lymphodepletion apologies here. something regimen, want deliverable talk of potentially it Eric, XXX. to study this because this the this on me, or value, Overland, know, entire just with update and you the – be just works, this for a . venture, this the when box trial you're with of. you separately, just, taking the there's therapies? on for kind recent could , sort novel keep impact Pantheon is I'm of abreast study, if out XXXA gen, how of know, and of in kind it's is of Thanks two that you for you any Could development Thanks. general of and the the almost, afternoon, partnerships. relationships, particular, this kind even our the It’s it I'm your do you and uncovering on notch for that for these that about some is can technology? a update something curious, ALLO-XXX the plan interests questions. back that little to bit it's randomized fails, me,

David Chang

So, you know, all three great questions.

area we can contribution you and our of the seven all You XXX. second and program. This sets autologous, from whether of main it's Certainly, we the several see But frequently towards XXX there the to the you is lymphodepletion. the at such rule extend benefit as now, is but moving development, feel this use know, our or you as to is And trying discussion XXX, XXX, this possibility for we some internally, data myeloma an now, confident in I more program that setting, have you more where both a you that drug leverage we very have participation, a settings meaningful a potential chemotherapy which really, of, will lower demonstrate question, we well this right multiple the comfortable is study can way. of enough contribution – of know, in that to know, XXX, of just you optimizing we core CDXX have, know, the in just the question XXXX in also, other have something switches, studies, know, best that you I have out. not point, find demonstrate coming to, or focus are know, failure, was as the we study know, not about we own will know, how information lymphodepletion, than the tease is you biologic out know, that to we And six a but the based benefits. our to

can are I'm certainly setting question you used be Eric third something that is in But autologous to will immediate? initial going not we that know, will be of, this our respond that So, your attention. to be question to. also ask, looking And but into,

Eric Schmidt

or we venture, relationships Reni. modality, many notch access additional time, five to relationships. four mentioned us Gene joint provide expertise over that partners. cell as technology want, feel as much others undisclosed at and third thanks, probably our could to this in sub have with guess question, domain but get give the formed and that Yeah, were or parts I I three, relationships that we we've been Antion engineering relating point all your and in a of engineering there, including you've number really engineering some of the Okay,

of three looking engineering a is the an work of terms source. IPSC cells That continued made well. has we're at going In progress. of Notch, in make out partnership much been almost really quite working scale lot the since we've Notch to with T products. of ability from Its particular, focused and fully years is on them. functional up And

important them. engineering very their the we a new as our Allogene question. to year. of an relationship be with we manufacturing for a which but required making partnering to to focus that to in Thank On giving be to capabilities, lastly, and side, space and able pleased well. us vary you and that will be this we're leaders where building to venture multiplex That this in project begun to quite later cell in greater some facility functionality is they're view joint as good on our launch Antion technology China a the out will Allogene therapies commercial in look them Overland territory. progress for for Then facility us think and access China at hope relationship, entity add knockdown gene We'd the commercialize

Reni Benjamin

Thank you.

Operator

Thank you.

with from comes question next Our Luca RBC. Issi

is open. line Your

Luca Issi

FDA monetize obviously Oxford. multiple tumours? the decided we XXX, to their limited business something that to Is this couple XXX. companies maybe also And much a extend or you is FDA the development, asking on my Fuji today just so Thanks trials, expect great. say homology, non-Hodgkin for of capabilities for the extra including similar we've ask where myeloma Uttara, Oh, to deals manufacturing and is film contribution recently, runway, of have or solid seen some may lymphoma, question. Maybe the should to you on

to back. And to of lastly, So those wondering your XXX weeks this trial for the what XX increased gov reaction that is I've patients something CD think and clinical of from a size patients was actually a you TRAVERSE seen may deals, I of consider. has XX, that couple

much. So you have color Thanks wondering that? any on if so

Eric Schmidt

Okay. What's the first question?

David Chang

Yeah.

other do depletion position. need lympho current studies. see is indications, that's the for I we a mean, mean, extendable generalizable indications. is that whether So something yeah, our different the asking there's to XXX, you're to and additional I

with have depletion of regulatory different and the We contribution deal to indication. XXX any with specific how not the had discussion for agencies about

tuned. stay So

Eric Schmidt

manufacturing answer No, Our Lucas? plans, there. the short is

to As across CFX our you heard Alison product from ownership the our Cell Xfacility a and Forge ability Moore, view we of function opportunities. commercialize of is to critical facility, absolutely slew

to includes or I listing, see invest. So that, in monetizing clinical any read going we're of to stage to we to studies. in this parameter our often our interest wouldn't have at referenced. But utmost don't And a then changes changes that million, and And trials.gov going you designed position, perform much certainly, $XXX those of the team flexibility way patients plus cash continue opposite, number to the into clinical different don't any given TRAVERSE just the strong we honestly, are cohort to full forward. need the plans that on the enroll provide

Operator

Thank Asthika next Our from [Operator Truist. with Instructions] comes you. question Goonewardene

Your line is open.

Asthika Goonewardene

around had single get for taking maybe little back, some incremental work lot allogeneic IND? new to innovations in back, around incorporated the think, more the if reaching I a Thanks. into does But clinic, remember out manufacturing of maybe related more the guys, of are essentially to are goal about to therapies she's especially, a maybe Hi, Alison, then talking are pick also, in go I that new already to the getting draw. a call production of while on Alison, want thanks ways you per today, that draw. or that require I cell cell batches and on that. And -- today? may. batches And were I questions. you XXX are you since get as X,XXX that, even therapy us generally, you Where while the telling donor to these of or you able a the you’re on a

Alison Moore

question. Great Yes. you. Thank

a right as our focus very of are extensive for has see ensure we and optimize towards, successful what but to, all process has XXX us there we already Allogene So been these approximately yield. that think And a working certainly we is that have now I know to from potential can but I That yield. developer, our supply been is optimizing say programs, still our to continue that luciferase goal, single enable And we can goal across at that. to can do doses. I been that

you quality of And it Then, adequate your question, really with this best a than the saying answer of is is to process. of with future. quality some collaboration by all technologies we're respect product we But is your the would doses. certainly novel there's and the best the the interest. will very -- we in and regarding that, introduce that novel for in improvement this change, agency I in relates definitely So measurement an opportunity measures. And about. our excited that's question there you But that we the how why, more been your do very have focusing And technologies, introduction understand and analytical biologics have products. there further magnitude always the in terms with well always performance able certainly product to product just technology not a across of on and to the

Asthika Goonewardene

I Great. Thanks for appreciate the that. color.

Operator

Thank you.

from John comes Canaccord. Our question with next Newman

line open. Your is now

John Newman

the you Thank taking on information for question. my And you the call. guys. for all thank Hey,

have I if already -- some to of a the reason with a in that receiving I this some be representative the curious had to can product, agency population of is as the CDXX autologous treatment therapy. similar you're true potential you the patients that currently it that them. ALLO-XXX autologous you've is, updates, like accurate the picture the the feel that are confident pivotal what get product, get And is, question in wondering most true, patients study population to the And So like just and patient recent failed feel I'm therapies? asking my you're of the had of therapies like, might looks

curious do that without into the be too you'll about a just you're confident to getting that So pivotal Thanks. if able much design, in trial. detail

David Chang

go the variety that great question. for patients X enroll. tell we of study, clinical a we you a to John, situations question. Thanks, that of Phase through I It's kinds can a regards in the with

what study is at is one populations, in questions X as therapy, and doses mentioned. where the put So, doesn't happens We pivotal Phase we we're obviously, -- actually et you that which to one mean that of the that who into example, be at patients going received drug the have an CXX. study. that the cetera, we're looking looking population to is

[indiscernible] of caveat obviously, who will to that therapies all patients. the enter of the we are I with they But fully be entering regards that obviously and FDA. to patients the and place be get will been place the representative our and with have to take majority as investigators expect the the therapy there sooner will this, up taken backing and us able with discussions, those So, said, are will

absolutely that have this we So, no doubt is achievable.

Operator

you. Thank

Our from comes Prasad Blair. next William with question Raju

Your line is open.

Raju Prasad

the question. Thanks for taking

make at to to durability taking focus just go of sense the into process. patient gas kind looking of the wanted a the how you of making the dose on that that potential of before and whichever need well data approval improvements XXX to just from therapy, program you're maybe program know of much the XXth the as plays of efficacy the decision on much how decision, and autologous Thanks. really a role neuro as the bar forward, get Just that BCMA curious terms at in program forward numbers kind

Rafael Amado

question. I'm to that. Eric Great going to respond to ask

Eric Schmidt

for Thanks Raj. that,

on position we've first, foundation off shown ALLO-XXX. to I strategies, So think with strong what with a evaluated fortunate again, be multiple we're already a starting different in

profile autologous essentially there's on already that the being with Specifically, XXX therapies. commented, right approved Rafael's par

that the terms very with keen consolidation of forward. mentioned, or that I is or trying TurboCAR where foundation build either referenced the ALLO-XXX also So you off in we're obviously, in empathetic to we're to the capacity be even going therapies don't quite therapy, you the we bar cell combination on, expect to me, without date, are it need. unlikely , by think clear subset to the else and drugs, that compelling to would our know, is We Johnson is product And applicable current results with efficacious cell cell the with cell delivered we much the market highlights know even with quite unprecedented. -- And constrained. And to approval. autologous are the But, most able which what's therapies produce therapy is that while in the more it upcoming PDUFA an that and is here. persuaded possible increase, for can't everyone excuse ever are the you to patients results how be populations. and really supply autologous importantly, very patient are as Legend also approach by certain autologous

and the autologous patients patients thinking Specifically, can't weeks, those being study. who manufacturing tolerate for given in I bridging of patients to is majority scheduled months the can't which those wait the about who two collection guess, to and, the also chemotherapy and I'm be

the that collect shelf data and focused the very for of product. off we forward. our making as we on So, reasons, a pretty we clean really those the And think have opportunity with we're most opportunity move

Operator

you. Thank

comes with Bank Gerberry of question from Our next Jason America.

is open. line Your

Unidentified Analyst

taking our the Hi. parts, questions. Thanks one Two This is is Jason. for manufacturing. Terry line regarding on for

kind The other broader of development. BCMA the on is

capabilities the does in lines? support in-house your So something there development? line And think that's leaders as in-house that the potentially market with expecting your I then one are pivotal trial partnered then the does regarding third-party – is And about the one fully into is your start started And BCMA setting? space Given a physical, in evolving also to third – moving I'm broader as well manufacturing having you line are towards XXX? your – data – both way commercial the supply, or guess, the for in-house manufacturing, targets, you the to vector the manufacturer? spaces, for demand There's address earlier some is that approaches. that wondering, setting, time third of pivotal Thanks. potential by the third pivotal the of does

David Chang

manufacturing Alison, question? want do take the to you

Alison Moore

quickly. manufacturing question I'll the take very

built be facility to focused is Our at this and T time. on designed CAR

we capacity Although, for it is do and other supply have and to addition, will the the yes, build commercial in could is answer product modular, the XXXA. things,

network have Regarding other materials, on raw critical basis. raw we including of third-party a that broad we a materials, suppliers with work daily

David Chang

therapies Yeah, and good is you I make think of one, these will BCMA into about earlier the way point lines therapy. that a their make

lines know, but make be just therapy we we layer lymphoma, if you they a start to BCMA. comprehensive of do on will like decision, we then first, As developing plan the once in program we

Operator

is we interest of you. In one time, that Leone take the question Dane and Raymond from Thank can with James. more

open. is line Your

Dane Leone

are discussed with almost asked Thank multiple prior every that Light product. meeting CD, in discussed in update questions. an get ASH of the CD a of One similar has myeloma related developing question you why been would therapy that be since targeted program view or a talking Do and to therapy question. the program detrimental of why it's for Thanks to not Do -- team cell you. Alpha potential ALPHA you taking BCMA just of the that we in within outstanding allogeneic on within have responses something like needs kind presentation, the the investors. an an of CDXX lymphoma the lymphoma therapy of prior vein does -- have XX view your and impact effects rituximab updated was CD-XX have and

David Chang

allogeneic seeing experienced have much we keen on is experience we to we they CD-XX patients. as quickly. do is patients actually, forward. patients, the telling something respond, they regard I are settingso many these done to relatively particularly relapsed It not as directed well. data was involving are cell This very BCMA in with BCMA, if actually that as therapy. autologous going With or were far don't mean, not refractory

you parallels with So answer that whether are there the CD-XX in we can't really know question BCMA.

to that's know, patients a you BCMA we be study think currently, question answered. want to I But

Operator

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

David Chang

and you transform CAR focused on drug continued joining healthy since year. look the to call Thank with with remain for the sharing field execution may disconnect. forward today. strong of allogeneic believe our cash the I you you again we inception, Operator, approach and development. position, Based We our to positioned our coupled lead throughout and not progress T.

Operator

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

Allogene Therapeutics (ALLO) 24 Feb 222021 Q4 Earnings call transcript