Allogene Therapeutics (ALLO) 3 Nov 222022 Q3 Earnings call transcript

Hello, and thank you for standing by, and welcome to Allogene Therapeutics Third Quarter of 2022 Conference Call. [Operator Instructions] Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. Cassiano, please go ahead.

welcome QX and operator, you, to call. our Thank a and third financial market of close, press update issued we the After results business release XXXX. quarter for available This our webcast and press are release website. today's on we best to limit possible. an to person call We ask to will do as your this our you keep and get one questions per as to hour as to many

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

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

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

focus product last years leadership development and, more is call Thank view, X T combination the lymphoma. initiation of It Advancing in afternoon. our will you, closer or of therapy. focused to to a B-cell large the for in off-the-shelf advancement readily Phase relapsed milestone, life-saving the making candidate refractory three with singular available our AlloCAR cell I a step for this entire to brings signifies Christine, us the an important the product, our therapy on CDXX ALLO-XXXA of start and field one potentially most my and of trial patients. today's over our X Phase T CAR good the our trial treatment allogeneic of

have T Being first unique journey, have we would and address, a ensuring challenges, challenges started being that also pleased T first we of we patient's to knew pivotal last managing responsibility. versus initiated special an product. AlloCAR immune we demonstrating set of were a Phase comes potentially that with month for host AlloCAR especially from you X to of an the our share imagine, safety very comes disease, of T we When and it there with AlloCAR accomplishment of T with be trial to sense protecting enormous the the would might but meaningful As set prematurely products. reliable the industry's CAR products, graft responses cells by rejected system, the respect manufacturing allogeneic

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revolution studies clinical next commitment at that initiating end, unwavering create in Phase UNIVERSAL CAR-T the to this our us very forward X update close the and places New allogeneic in goal. a Showcase to one BCMA that November meaningful by R&D ultimate patients to looking our trial to our on our blood step first investors ourselves, on To providing for much and and cancer York we alpha trial and XX. in are We to CDXX have patients lead And tumors. cancers treatment solid been delivering products

fully a time Showcase review lead discuss the in flexibility While of our landscape. of programs to for update will findings we and usual clinical believe and provide target R&D practice context more the to our that conferences, such medical is gradually our evolving

to like over of and few call to collaboration the like-minded comments make importance specifically would individuals I more institutions. to with Before a I the related Rafael, turn

supply best aimed road can to This join T the be opinion Allogene investigators care T who date since the effort T top to Institute, emerged challenges of accomplished pioneering five patients is for products others Together. from desire delivery next patients, Blood personal on bringing Sarah launch sites. CAR we members years enrollment. and Colorado chapter. trial more they therapy to that is have City clinical and physicians same had Inaugural the partnership note, commended them, our as call success autologous by advancement education CAR kind Cannon innovation. in collaboration of Center, Moffitt the leaders many ago. of Their the pleasure complex I T dedicated a many autologous CAR us conducted Our initiative allogeneic only I'm bring through in by therapies Cancer clinical supporting options towards leading address lead and Mayo in to include bottlenecks and in inherent Hope. a patient of among the at and in cell this to participate the from individualized sponsored chosen KOLs the investigators trial are These initiative of and again working centers of is underscored the clinical of and their by Cancer honored On to collaboration, Clinic commercial this of trials scientific CAR support key CAR with vanguard manufacturing T traveled Real dedication the be have introduction therapy. and out with we access of with of of bottlenecks their the to created engaged Cheap its process patient-focused world autologous a the first oncology the

we started CAR with T all As of patients. noted eligible we making available last Allogene the readily quarter, to goal

complex individualized conclusion employees, call our pharmaceutical sincere and over near to investors, procedure a to of from on we the have to Rafael. together, on-demand joined turn journey. transforming this My we thanks patients we fourth I will an CAR well year collaborators along off-the-shelf the As the all our therapy who believe now us to path product. are

David. you, Thank

As David have our trial. deploy ALPHAX in launch to noted, registrational positive XXX Activities ALLO-XXXA with single at EXPAND our cells or to trial. refractory a initiated teams trial are are utilizing ALPHAX enroll relapsed overall trial Phase potentially B-cell rate endpoint The dose and will response lines anti-CDXX patients very companion also X key ALLO-XXXA million response. CAR pleased endpoint duration of primary underway lymphoma patients large received of therapy. with a two cyclophosphamide XXX prior of This trial of have approximately fludarabine a have lymphodepletion single-arm received not who secondary will at regimen The with prior least ALLO-XXX. and plus therapy is of of this comprised our

ALPHAX the response. active enroll trial, registrational for either cell expected control we're with European standard of intended of rate randomized U.S., ALPHAX lymphodepletion demonstrate cyclophosphamide a same our As dose patients of Medicines of in potentially and regimen. same we trial with be to clinical and or will the to the XX approximately and cyclophosphamide lymphodepletion also arm site. lymphodepletion progression-free of Agency to separate contribution is initiate response The fludarabine secondary key ALPHAX onboard European Patients discussions fludarabine at XXX site overall continuing trial, to the with study EXPAND the regimen arm. the endpoint clinical ALLO-XXXA to the ALPHAX ALLO-XXX is of single and the endpoints a trial in the alone as duration survival the trial and primary The million receive

Showcase our looking data our R&D to at the at CDXX program from sharing We the month. clinical forward end of are

ALPHAX X We being deployed are dose rationale longer-term share from for trial, of and Phase the including in X. schedule our and to planning follow-up selecting ALPHA Phase the data ALLO-XXXA

manufacturing from to our with Alloy expect patients process. We treated also share outcomes

program T growing directed in may need event, for multiple will longer-term to as past updated ALLO-XXX only XX the the data the the myeloma upon profile treatment a dose that from we Based we have to patients with that innovative will with dosing. in required of myeloma. exciting potential cell program, BCMA multiple unmet clinical be treatment this concept. recognize in and we paradigm. the for play also and We transformational ALLO-XXX patients proof treatment therapy care. recognize Showcase outcomes approaches in in believe At R&D immediate appears very patient therapy advance previously the or shared, program addressing opportunity advanced competition feature This important transpired plan Our share the is to the we the that relapsed single role physician of our onetime established The having refractory from patients. a in data allogeneic ALLO-XXX play ALLO-XXX in AlloCAR could that these need believe interest increasingly to dynamic such further the and off-the-shelf BCMA cell an for the that targeting market years have among option profile is myeloma with provide the the has what are Nonetheless, exactly is we differentiated myeloma.

weeks, on to next now potential and not and we update discussion innovation, Eric. but the Over over sight now I'll for we sharing this have forward with few the on we to look an Allogene, the treatment in of expect continuing We mission cancers. you of turn blood to XXth. to November call products. execute of innovation around a days potential just believe lot At line to potential

good and Thank you, Rafael, afternoon.

on remarks, in activities to first focus of formal As I I'd update outside my the United begin China. starting brief on a States, like

in into honor adoption United partnership development, opportunity to not a also but in T therapy knew strong two Biopharm Overland inception Overland rights it on CDXX, the options of had obtained ALLO-XXXA, joint technology. extend CDXX Ts especially manufacture program We'd Allogene CAR our and with many to to U.S. CDXX of AlloCAR shared manufacturing Servier has important the venture, and employees. under to China, DLLX that to the As license that allogeneic hurdles and diverse skilled advanced state-of-the-art we Allogene BCMA, and we of CEO, FLTX succeed, and his autologous the Servier accomplished. reach we CDXX forward team of a commercialization geographically ALLO-XXXA Overland look of Greater Since to manufacturing arose from recently, Servier, venture and Developing create on outside Overland other even support where less to new AlloCAR necessary will many as assembly partnering revolutionary ALLO-XXXA this the vision dispersed. ex in collaboration no targeting years we Korea therapies would T today It had been components to longer from Most and would than late Biopharm. that little the of is just will cell or that the and leadership has XXXX, they population Through highly a cells. Yao This China, in rights. with was AlloCAR large-scale focus has ago us September, Allogene large, much Shanghai. of a U.S. Overland, begin South products candidates Singapore with and a as retained a of in other they with was greater China, our so, been in that you the built recall, Allogene Dr. focused including partnered face Rightfully supporting T team while agreement. States. us have In Servier launched Shuyuan Taiwan, allow facility. this therapies represented commercialize informed and the the seek

to U.S. have we opt the carefully pleased evaluating. are are right We which ex obtained into rights, to

rights unchanged. are commercial U.S. Our

to financials. $XXX with quarter quarter equivalents cash, million Moving the investments. and third ended cash We our in

noncash and development million, stock-based were which Our and noncash $XX.X $XX.X compensation million of XXXX, million QX of were $XX.X compensation the stock-based General million administrative expenses expense. of includes for which expense. quarter research XXXX includes expenses $XX third

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will first of Richter you. Our from Instructions] Goldman question Thank Sachs. Salveen [Operator come

line open. Your is

manufacturing? plans our necessary bit taking on This little everyone. between Thanks maybe more you speak Andrea Hi And transition the could your is your for for Alloy are Salveen. studies? what question. particular, as that manufacturing process the you in on for current will a and David, be comparability

Chang. Andrea, is Okay. this David

me So let take question. that on

on is have the process. said treated that we our of programs. decision, reference time to lot data has will think took Alloy what come This that study, of we asking used have in been pivotal to number of I in something to be that are process a what you And a and that is we in review. used a that's across based our clinical patients lot Alloy

step, with we what doing next is about Alloy is are the which So, process. important all the question

exactly from what that to Alloy using manufacturing doing to manufacturing our and process we familiar few are with, own to process. we steps personnel We saying, facility that deploying very our at bring are process equipment you're were manufacturing validating trying that that and involves CFX different the

of period we expect to occur time. So, that a relatively short in

Thank you.

Yee from come will question next of Jefferies. Our Michael

Your line open. is

concept for can the Thanks what this overall will regards set you the is standpoint tables perhaps can the expectations both there, be show? the a out which response us out is And have bar the the With rate rates, some treating what the and bar there? help CR versus that labels say standpoint and and and were look team. and patients myeloma David good to different at of should you question. drug they forward that to of going we a from just update, types we PFS versus multiple from Hey what all we and

talking provide have about, and XXX of XXX. initial back component update be on of is the patients Mike, been the XXX as the in part we And update essentially big the so we've will R&D yes, the that longer-term follow-up the we ASH on a will XXXX. Showcase, findings reported

both durability of key. patients, that as from other those well sort the parameters will following as So response be

quickly. been well asking myeloma is significantly a this we've as where decades last to that is as the So of saying, And as treatment field the really what the changed is the is question treatment over that multiple limited from about the sequential. bar, pretty important has something also you're evolving couple combination paradigm

we product, benefits what So are CAR really treatment. currently, here from approved, there emphasize why T space as we product is needed. we allogeneic two can about is of approved, needed. This attributes differentiation different T talk bispecifics are is therapy and an why cell coming allogeneic a about but being CAR are the other also autologous there but is many looking that is CAR we where that T therapy are can allogeneic are the

Rafael differentiation. response number which ask of that, And be patients on all questions, that let constant the So some one detailed matter me making the this the a others. let is to really something that treatment key based we of evolves decisions. small we comment to with in which are results discussion emphasize no need, available that to me be patients how with the the in investigators the and and is rate has with will always also But great and about are, that, of

Yes, Michael.

was R&D treat over was honing of patient we last time, encouraging, of approaching the follow-up with at and products was we another the lead giving which with the of was at clearly, Day, that into. given very valued that for ASH upwards have few durability the the already every treated rates will of bridging of need eight plus that presented GDPR range. data study, therapy, now and response approved depletion, of pretty a one virtually additional XX% lack At are patients of in year much months, and year at the we the it by numbers particularly came physicians, ability the the to into So

us has pretty with I definitely being therapy. CAR with becoming days use they to a telling for and the close into autologous would that attractive of but -- within that trials. So investigators that the that data T and for can't therapy to are in of forward get superior, repeatable really study clinical wait region very this us something numbers that we terms we like move are is us would entry, Clearly, patients come is have

a we disease there from in we allogeneic with as multiple that in and for the XXXX. is there therapy, products a So like for this. space will see the presented I is an definitely any cell And evolve time profile definitely room think product time last for

you. Thank

will from question next of Tyler come Our Van Cowen. Buren

Your line is open.

at a the with Thanks CDXX received guys. anything those you provide Hey understand who for about it's is respect but unique update. will who data not? BCMA Alloy on manufacturing XX, actual to trade update very much I the high Alloy level? for tell when be have patients can you stratify the November what And secret, us and/or process there the a you versus more is clear, to

Yes.

So, talk give Tyler, be a right. of lot launching the you absolutely the not we that about. into will with the outlook insights to will R&D are in trade some process we're manufacturing, pivotal are why secrets that there related to we we Showcase, are landed study. as Things II able But

for So the stay tuned R&D Showcase.

you. from Truist. come next will Thank Asthika The of Goonewardene question

open. is line Your

dose I X from data the guess patients, study sense data related, portion more you my more ALPHAX out on that the Hi patients that Rafael, of just and Phase wondering more up, helpful. us did be XXXX, guys. that indicated any at taking help ASH, if would Thanks and well? you question. October X since there more communicated like was Phase patients, XX, you in presented could you the for coming be UNIVERSAL XX I mentioned And the five update patients. few cut enroll as a will the

into exactly Showcase of on get we'll patients full Asthika, treated. we forward where at comprehensive the your how update of XXth, let But not event. me we a the participation Eric. you the course, certainly, are and in take We're with the It's give And program. many that to look we've to conference, going additional one. that

these focus following our patients has and about, talked now of getting were a been both over treated performing on up better that how we've term time. As of they're sense some months programs for longer ago

treating be that opposed X the the really will CDXX more starting program patients. think we've focus towards I So lot Phase the with Phase to been for as eyeing X in particular, a

Thank you.

come William Our next of question Raju Prasad from Blair. will

Your line is open.

for Thanks question. the taking

of to a the sense get wanted EXPAND Just trial.

flu versus PFS flu it of with like plus dose the ALLO-XXXA sounds So a endpoint. it's XXX cy with cy as

the So you is see kind a just the curious non-inferiority do show be I'm want arms? to success increased expansion? really two going here Or a it know just trial? to to considered that that from of were between measures

the And Yes. on really question. dose of XXXA as Rafael. XXX, the This is the Thanks to isolate to lymphodepletion you're same efficacy. right gets regimens. did everybody design. safety ALPHAX, for at the Yes, as cell and It's such, contribution two both we

regards will with the that In to the critical there's be and that of lymphodepletion, and a thought sample size of clinical conviction adequate the lymphodepletion. clinical terms survival, and a response The a endpoint, we data. are trial. of expansion ALLO-XXX And us will data concentrations going to between clinical model from have This be we which a is not actually is is correlations outcomes, therefore, we be the to leads positive dose XX outcomes is patients. response and of this real XXX it progression-free and one suboptimal. to have also endpoint dose And believe components of poor design, a obviously ability it's abundant showing outcomes, lymphodeplete and data required, lot

looking XXX a to of we'd that meaningful a that meaningful critical going the So sense is addition be for believe gives to you is that because fact difference really achieve that really outcomes. are we of the

you. Thank

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line Your open. is

just going you earlier are guys. remind that, the patients and forward And kind patients -- it treating therapy? the to the Can any therapy see afternoon equivalent to any of just of were you in the the of Can good related exposures any Thanks worsening, or across us questions or of studies? kind studies? to average two study, lines you Hey with different of for lines post a you're was look to like sort November in bettering in greater XXth. be talk taking did of And seems [Indiscernible] than therapy? of what bit guys little registrational the

LDAs, such them of This heavily -- didn't responders. is were predictors, three responders number efficacy We They of four them, with of comparable heads stand triple these like lines therapy other would We patients received looked out. lines had as the versus certainly parameters, Rafael. relatively multiple therapy pretreated. one at double one cetera. and such of across That's abnormality as about Yes, of head, that to saw therapies. good of actually were poor a was most parameters parameters chromosomal that discriminate et

So that regard, two critical to more. that are in the lines or refractory they is criteria

you. Thank

Our of next from will come Breidenbach Oppenheimer. question Mark

Your line open. is

Hey good afternoon guys.

if call, I seem the were So, that's remember us case. on wondering And therapies, by including you the I you to UNIVERSAL BCMA-directed the still myeloma remind bispecifics BCMA trial some can options is excluding earnings of CDX if and year end. last pivotal BCMA talking multiple or Ts? guess patients CAR in exploring the just Blenrep about with I'm any And prior also,

Mark, Eric. this is

turn to first answer question, your going the UNIVERSAL take part Rafael and it to that then I'm to me over Let of question.

be. the in of those that at our In intend end, course, the be we'll on the fairly And Showcase follow our year I providing we for around we've program that's BCMA on next program, terms of been steps steps consistent think through could guaranteeing XXth. something saying next what communications to not at

and thinking program. So again, our you'll that event, at please on get the latest for join what's next BCMA us

are that patients hadn't, and that difference between antibody saw the received have those we in that general, those therapy, received no patients BCMA-directed And were in Yes. numbers With had have therapy. that regards received to the allowed those that therapy, but cell UNIVERSAL, small. no

Genuity. Canaccord Thank Newman you. The next John question from of will come

Your open. line is

that if on is regarding process you manufactured talk about to a the approved how after thinking manufactured with Phase one the how product at process the Cell my Thank curious for CDMO the the just you Hi that's taking Alloy could process, you're moment? Thanks. Forge I'm product little as Forge guys. at incorporating there comparability one I'm plan pivotal using question. you just X? Cell bit curious for into the Alloy about being

David. is this John, Yes,

that we the process, that Let announced the process that take obviously, Alloy that will have pivotal is question. me study. as product the support

terms of the In across which say going the let as lot me different demonstrating were some programs. terms technical comparability, we that testing of are a the in of we processes questions just into details, have done that already different

do I that operations has So our do one analytic to about key team demonstrate confidence have comparability. the in things technical to the

XXX, our just talk we So we about details Showcase some let is realize we the me it, Showcase talking chose Alloy And additional R&D analysts design carefully. have the development XXXA our process. lot presentation landed other Showcase will that little This is to analytic a a and from as have well topics driver also comparability. trying something which why to why the the the to go show and complex really we the more really when regimen. and that have we also, dose have we'll a apply the a of we bit ultimate about clarity in is The provide all provide the and for as lymphodepletion cover very R&D has as experienced the our answers. that final that to are And a about provide of as context. to we a it's the us those little think the decision Showcase, the we and we we best was R&D on with that the thought confuse history knowledge investors, And as in more the have you, and we about things not way I of inputs well study to with some in issue, really recap setting have time the that based felt

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mean only away. about -- I up. really. weeks tuned, about than coming it's is So XX stay November And four less

Partners. next The from Thank Guggenheim you. question of Schmidt will Michael come

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Thanks you looking forward Hey dosing just was that -- was to concept of guys. something for one-time redosing looking I XXX move I with or that other was for for CDXX? and to -- a it companies at still I thought well, is applies if are a onetime decided is wondering, programs to consolidation, the my taking see regimen that ALPHAX dosing you other thought interesting therapy question. lot is that's example, interesting. at that as unique something think if that to after

things the mean good Yes, the single and data, we very consolidation single Michael, the have I data-driven sort as dose clear, important key and drill treatment dose clarity the And really choosing the way we as very together, when put as compare the the that certainly is driver what And the completing a well -- we with comes obvious the a move that we felt is for treatment as of is came investigated with of convenience we when single question. conclusion will those decision. of we the end, mean as looking At is that well it's consolidation both I that dose. dose. as forward. all single

that different about The question programs. is we all second will do across this something

data-driven decisions, investigate to we the decision and future continue the on make and We right will programs. will make

Thank you.

come Capital Our RBC Luca next of question Markets. will Issi from

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rate, the at for But the and about to not opposite? FDA you make Can response superiority and and thoughts. feels statistical asked much to PFS to asking a randomized trial for the It question. the on trial one talk use endpoint your secondary the will we'd for Hello, again, that and love risk just trial also me hear taking some to great. primary longer. you much so Maybe the why endpoint CDXX. thanks PFS as

Luca, is more question. Chang. Hey I response. of this And think thing Great technical Dave this is a

there with certainly response. study of always best rate the used of way has it both single the study, endpoint as as duration goes at a the many survival. overall When progression-free rate and as duration has study, randomized bear response a In the to and So me. of study, of FDA randomized time-dependent as look well components power response is well to been response

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will Bank of Gerberry from America. next come question Our Jason of

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is explicit that an last just get that just guys. you really I can moving helpful. Hi my EXPAND on be specific more question, Thanks questions. registrational regulatory wanted support clarify on to point, just If bar forward? to maybe for clear, would there study taking that be David, this for to

that? So Rafael, do you want to take

Sure. mean and durability superiority is powered of response which BFS, CR it between responses, really long-term PFS. a is lot a in therapies that because drives and study of I that's there's cell not whole for difference it

a reasonable based looking bar So that which study other for. there set the is isn't imagine par is set There's one size, and and we're But that the well, by can is small, that, based is difference on size. a is really is of the the relatively VAR as superiority detectable on sample than it a that the safety for which question sample also important. you

come will next Thank of B. you. question The Patel Kalpit from Riley.

open. line is Your

interest trial? therapies? approved given the you -- on Good the from has this constraints event? of afternoon. interest intend for enrollment And manufacturing Yes, for the up updates maybe the question. ticking how is Can BCMA been at you the Maybe going any study taking do one on providing ALLO-XXX. the Is hey. Thanks for then comment R&D that

a XXX, in study, on Showcase it's the hey about products. for know, dose a dose question. We've On that ranging as R&D continues. escalation Eric. talked and study, having you Thanks we're Phase Kalpit, XXX X the that focus yes,

won't you any on from So goes the it of year, update program as we'll data this you that seeing and be toward forward. end XXX

yes, all as bit in interest can you of a our fair of As investor or imagine, well programs. investigator interest BCMA there's

you. Thank

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is open. line Your

a Hey for ALPHAX have question. clarifying just question figure on taking Thanks great. I my trial. the

potential be the the if about regimen, patients redose And put redose the be to just potentially in would dose for trial? Following you into actually would be on more that that maybe question trial a could later what you the on the criteria the so, could the single in redosing? talk And patients?

Yes.

sort is something no question And patients, or of analysis. frequently trial keep The development But which the this when demonstrate of perspective, somebody study autologous effect we censored efficacy clinical after mind gap] the usually about dose. In redosed David, in the when progresses. is Dave when get somebody treatment redosing, requires I the any when CAR is T, that think Phase investigated. that's a will responded benefit of there X objective of Phase the X Chang. the be the the single So from those get. we redosing patients from having [audio will be case And happens, who that

will is going the definitely part study with the as as of analysis. an the when redosing the investigate But objective an we So plan to regards opportunity, forward, pivotal exploratory study. there redosing not the primary of study, is

Thank you.

come Jack will Allen question of next Baird. Our from

Your open. line is

in you much. And that Thank sites well? quick initiated to congratulations you wanted hear there quarter. update you ALPHAX things on settling more team and the relationship. the then can progress the to I Thank an the and can so to where as hoping sit was as prior do might would Or it you the this Servier touch Europe? relates to on And JV you to study, when much we news? how think I provide Servier you get so do

a Hey didn't the clearly the Jack, We beginning mind initial little part question, you was your of glitch. part of repeating hear question. bit there the would of

Yes.

the when was understand in to we studies European relationship. the as Sorry update quickly get about to start I may relates it as rights you Servier about hoping an initiate well? could asking and Europe I was to CDXX that. for how

development we Thank that as choose. question. Jack, us in know, of for Servier, Yes, in and you the secondary they the CDXX, the issues no Okay. we back should essentially to allowing you, U.S. the decision outside on longer as September, disclosed participate made

the option to rights global rights. We take just over to have with our Right know, it's, as the We CDXX. collaboration the United under have Servier. States you now

XXX% to potential for certainly, rate we an to we're carefully. with consider come would quite the of if But an that's does So It attractive product be program choose costs, that as paying also to option extra market we our globally some XX%. to opportunity. current going the is the opposed

now CDXX we're of the doing already Europe. patients what we terms with planned through right In enroll to Phase X study, with the collaboration Servier in

a provide was So for it global conduct that the registration global our prove to always positive. should plan would study

you. Thank

come JPMorgan. will question Cheng of next Brian from Our

open. line Your is

David Hey question. for team, taking thanks and my

the program Alloy us there Alloy or well? the Thank is BCMA Alloy if also is for you how give be in deploy deployed only been CDXX on is color some you. equivalent process, CDXX, in has your place? on Alloy Alloy process an long to Would able -- Just as

Brian, is David. this

So the time Alloy, a or in which I'll fourth this we're call. into question getting take about think the I third

than we've is process it been programs. across and our in has than the XXXA processes used of Alloy one So definitely programs, that one more been testing -- more

across able for definitely, the from of how process we came to being will sort program the about Showcase, data of in the pivotal helping the So our it study. the using as generate plan we data to a supporting is I And well decision-making. as Alloy R&D provide thought mean,

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my for guys. taking Thanks Hi question.

Thank the gain if to just Just know may. evaluate of we Day measures from that curious you. and collaboration with one pharmacodynamic clarity was SpringWorks the nirogacestat. some R&D me, from with combination evaluation? ALLO-XXX update, I pharmacokinetic reasoning I I if would terminated and to greater you in the during as the

secretase gamma the important gamma that benefit the try we didn't Showcase answer we I'm with this see R&D that forward Eric. added of the we inhibitor question. study an ALLO-XXX data for is not going in sure the available going the you we'll something hands. addition to to forward. secretase meaningful things the the inhibitor It's already again of to to we're in arm Honestly, is talk that so. yes, development or not of this trying to And know, from we lot as a XXX, have the consideration Thanks and of we not be about, make benefit do because our want whether arm trial to a and Rob, that were future. you that moving discontinued and certainly is the form right

Thank you. The next question will James. come from Raymond Dane Leone of

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questions. be you ALLO-XXXA itself R&D well? get you what to to stuff, studies thank there? to maybe and the study need look Thank the going, tackling then the still happen both up steps Could as of pivotal EXPAND kind and to you. I done still Showcase. taking forward for and just Just type Hi, internally clarify the study needs blocking what

Dane, is Dave this Okay. Chang.

needed, in of what's done. is Alloy So everything process, terms already

made the pivotal used that Alloy patients we are that the process products have enroll into be as We in will study.

the cells making as cell products are people the operators. utilizing is this at there terms on question in study. manufacture manufacturing in step the the So enrolling who And terms These of us process using critical our is the nothing to CFX, a Alloy the start to patients the facility. pivotal well underlying as that it actually for machines manufacturing the is what's Probably would process is, what your the bring to take of Alloy. qualifying

to doing is ongoing. that So already how we familiar about very about and this work go is something the are this,

Thank you.

of will question from next Ben Our Stifel. come Burnett

Your open. line is

up any strategy. or CAR BCMA profile you any you patients autologous much. to or interest upstream? think efficacy your the in trying just thank BCMA experienced of elucidate value the I XXX Hey on I in TurboCAR guess even very do ends myeloma the multiple had event is T in moving that there's there a question

BCMA BCMA certainly is and many is whether not, patients of unlike the progression question. a space directed therapy question in another interesting or be an that with BCMA definitely of may this after are directed lot interest. It positive know Ben, patients We effective Rafael. CDXX clinical a therapy it's still

I with question tackle dose as think the the that ALLO-XXX, we in us patients, it's future. it's to but are, consider for Eric naive really BCMA in may in premature escalation we that question a said,

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

you. Thank

very First we thanks person, much R&D of very insightful hope, you look I today, for all, thank forward of our and and joining month. you questions, in for later this seeing to us Showcase at many

may disconnect. You now

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