Allogene Therapeutics (ALLO) 28 Feb 232022 Q4 Earnings call transcript

Good day, ladies and gentlemen, and thank you for standing by. Welcome to Allogene Therapeutics' Fourth Quarter and Year-End 2022 Earnings Conference Call. [Operator Instructions].

I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. ahead. go please Cassiano,

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

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

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

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

reliance not cautioned to to these are obligation You and place on disclaims statements, any undue Allogene forward-looking update statements. these

the I'll David. turn to now over call

hematologic by since therapies a first you aim become has potent importance on who to year a joined of advanced after the agents types have new the and autologous all industry serve. the our Allogene matured, for thank greater takes were the will our to inception. since shortly Allogene's of have fifth greater patients several approved sparked and mark for Each conceived XXXX to anticancer our we most malignancies. Christine, the some you, and CAR-T year, These Thank FDA. call. as was therapies work organization

demand, its autologous its limitations. cell as by inherent heightened therapies But has also success the achieved well the clinical as

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now are constraining the for far modality growth to and of meet ability needs, therapies autologous patient as growing outweighs crisis, demand the facing the patients. for limiting We a thereby this access

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our be ongoing year, in on as B-cell I are becoming the pivotal by as study clear, this II begin of will increasingly vision to and large fifth our we when execute And we timeliness evidenced able potentially Phase believe lymphoma.

other losing developing us is the that of in clinical different minutiae it modalities. up of those get to fact For caught comparisons, data the we are cell is what development of easy immersing while cross-trial of therapy, fundamentally sight from the

patients with of enrolled to to inconvenience treatment end. were for infused chronic of with dose, months XX% released received can patients onetime cumulative In and is able X ability most AlloCAR days contrast products to off-the-shelf autologous in XXX% most of toxicity cell free products advanced administration. reaching and of hassle, treatment. unlike of unique on therapy, start T our product specification. continue manufactured consists In all its treatment onetime within biospecifics, that X And treatment enrollment, of product the provide for trials, an with

initial skepticism. who therapy status. therapies met said has inherent today, not blockbuster us be its for T it developing non-Hodgkin of often could involved some role in naysayers considered Pharma groundbreaking autologous is innovation Those done. played True is the of a with But of the a lymphoma in initial limitations, at despite Kite remember, therapy development the and achieved us CAR

we skepticism at The no is what allogeneic today than faced towards different CAR-T Kite.

of comparable share groundbreaking is We to even current have compelling data our non-Hodgkin's lymphoma. the face in critics, of therapy the in that

an in favorably that have competing but allogeneic data also data multiple excited the myeloma, early proof-of-concept of path in [indiscernible]. We shows an on CAR-T is

be we bill, are skeptics thing we on manufacturing, the on filing only is the and its execution will development, execution innovative to While execution; for fortunate know leaders that commercialization. clinical in execution BLA quiet this

to talent resources we Fortunately, to other trial. pivotal me Roberts. it Zachary have And industry's that outstanding execute potential reason, on the II next first and I'm to especially Dr. excited for Phase have is

pipeline Research in President Executive is bring one era I the As be products. next more as investigators, our of progress CAR-T Development, Vice the we and new our and trust with there on to no frontlines of

desperately that someone often and and desire, challenge time. we And understands, patients to the embrace loved something their give back ones, urgency they first is who to so

the perspective to year. R&D I our upcoming Zach provide like on would now for priorities to invite his

Thank you, David.

I like Before to about thoughts I'd share few activity, why about a I Allogene. joined R&D specific talk

it's regain I opportunity think through join to trees. a forest when that the you sight fresh of and bring perspective an an organization,

I to opportunity for November, And many team, transformational been R&D to having of of the was showcase knowing exposed freshly its the had with colleagues the last the engagement my But outsider's quite initially and join back really airport, stakeholders, everything since ride Uber on that the Allogene passion was professionalism shared. stayed data its the Allogene, despite about the the of clinical leadership I investigators. some So followed had the what time company new to perspective. I an the inception, of when carried me

in X this clinical options, other of I generating all few had candidates patients saw across X product. therapy cell product an different allogeneic who results with and meaningful malignancies

got For this Allogene years might to very have feat organization's about in future. small for me and excited no this possible what achieved all X be was

an decade, walk, has of as who I shared oncologist been who these around showcase day I the often. knew ran when cell very for single most I last were those in patients the the for don't working every Head care to R&D, and at opportunity showcase, the to that used offered development come As forest. of join the that Shortly didn't the therapy like towards someone after I was Allogene results

Allogene I've as David and as rightly X at now insider, steps So months, talk noted, for let's an about about the now about next all critical has the execution. trees. been are

last II Let's our and about our Phase their AlloCAR what Phase availability I few the with first ongoing our mean I've trial of investigators, the spending weeks pleasure had about can our talk the many equally I patients. data, share that study of CDXX for of they excited program. may are and T

CAR-T are I lymphoma. data the that comes We we own, with competitive and are company with Data first of responsibility to product, allogeneic the allogeneic This are ALLO-XXX proud administration in us efficacy welcome that B-cell CAR-T and support that therapies. generate in a autologous those CAR-T Phase we the the only durable from approved our to it. the ability and trials comparable single puts ALLO-XXXA and of durability large of a to of fact very of deep an and generate highly responses league

XX%, at evaluable months. with patients X XX With data months the As cells of treated lymphoma. X X solidly approved X CR the non-Hodgkin's CR in respectively, the at longest and XX% R&D lowest rate and that remain the process response XX range time by would received patients response ongoing possible data showcase our ongoing among durable at overall months autologous cut, were who XX% follow-up complete regimen CAR and CRs patients awaiting XX and Alloy FCAXX the rate single-dose rate cuts, established durable CR the T for the a at at was months, still is XX%, the using was all Of months rate material. FCAXX, single-dose

data, an standout the basis, have patients products. autologous in one by the all among bar and efficacy exceed What of to potential that is trials our is Inspect intent-to-treat the product, established could we our on that received an treated the argue

CDXX a profile, our demonstrated any safety syndrome neurotoxicity cell-associated disease. with effector Phase immune severe I manageable trials, or we toxicities, no In observed graft-versus-host dose-limiting

addition So to is that we competitive to appropriate T trial in have that able may favorable patients. data clinical now that that be shows efficacy CAR offer to off-the-shelf profile safety a all available immediately adds we an product,

open to potentially ALLO-XXX quarter. lymphodepletion demonstrate in allogeneic Enrollment early Phase with trial, the the the in the which ALPHAX pivotal in of EXPAND has will ALLO-XXXA trial regimen, which be clinical CAR-T to II is to intended the contribution second enrollment begun

earlier Phase XXXX. targeting initiation line preparing large B-cell in of are III half We a for the lymphoma, trial first study in

treatment data BCMA; universal Brudno to NCI that ALLO-XXX in feasible universal to and just be CAR-T known Kochenderfer, the by trial is of Doctors Nature I moving an corresponding myeloma. renowned in Jennifer multiple Jim what The researchers, Medicine. in demonstrated was myeloma Now The published off-the-shelf relapsed/refractory reinforced month, we've true. last study Phase editorial from has

in CAR-T me is off-the-shelf that allogeneic from with myeloma, multiple are on development are proof forward 'its response specifically cellular that CAR ALLO-XXX; effective therapy. road of We quote the autologous relates to demonstrate therapies.' ALLO-XXX to T an to first similar Let concept drives editorial more their approved field anti-BCMA it the rates as proud to the

responses the at months. disease substantial GPR or months, of cutoff, median responses. were in data longest as the median duration residual response was presented rate The response XX% was X.X we most was overall recent very good the response or on ongoing a better October demonstrated rate XX, Through XX December response and XX.X XX%. at of in All cohort, XXXX durable follow-up and better the with The data months of the minimal the ASH ALLO-XXX partial negative. FCAXX

population, days patient and none Important initiated of received patients from X patients as days with enrollment. early a of median as to and this enrollment bridging lymphodepletion from X the therapy

reversible low was patients and The safety GvHD. XX% and higher or manageable, profile patients grade X prolonged infections grade X higher ALLO-XXX no experienced of X or or and cytopenias. Grade neurotoxicity X experienced with

patients efficacy excited clinic, recognize myeloma are the is receive high very also has that autologous ALLO-XXX about in shown what in remain we who CAR to for multiple we While the cells. T able bar in do

of options process BCMA evaluating and ALLO-XXX assess BCMA program, we As achieve performance. optimal our to improvements candidates, ALLO-XXX we across for our are manufacturing all our

malignancies, this persistence. work is create cell our just approach and of expansion for a for lymphodepletion hematologic using window in Through we've proprietary a our But to beginning. concept platform, including proof ALLO-XXX the established to

concept. renal classes inhibitors of cell start carcinoma. in there ALLO-XXX is tumors to in heme tyrosine exposed tumors In RCC, remaining that main and standard are a have these patients to checkpoint of with order with of therapies, Once of study Our establish solid is solid immune kinase target X both I CDXX and been Phase includes classes, options. strategy patients few proof evaluated in in a inhibitors. of being each relapsed/refractory in a TRAVERSE, drugs or care to TKIs bridges

is XX% need third than less unmet One in The study data cell recent line pivotal stage median medical RCC. was the benchmark in cancer. objective profound data renal These trial survival the than tivozanib X and the in was less months. this from progression-free advanced response highlights rate

TRAVERSE data with promising demonstrated subset our patients anticancer of activity confirmed X Initial in the RCC. CDXX-positive from study

who rate control lasting achieved was longest As XXX%, X. including disease of a patients partial month the X response response the until the with ,

GvHD. patients. expanded grade prolonged it low profile to enrollment or safety the was dose of low exciting cytopenia Grade X X with the second only Grade type toxicity escalation X X in observed grade, was case Across patients. occurred generally CRS I and exception in dose-limiting dose of activity has that of also see in level Neurotoxicity of been in no X grade cohort. patients reversible One XX a manageable and this CRS. in was was higher is X trial. hepatitis autoimmune While with treated, early, Phase the seen

measurable suggests than who response, shared terms to CDXX levels in CDXX. we've who that that of do better of patients data absent or The expression, have tend unknown have those

designed assay, enhance So are CDXX diagnostic expression levels selection. prospectively to now new companion assess we deploying a in-vitro investigational patient to

combination for In in with ALLO-XXX expressing cohort plan such hematologic indications, dose to We therapies, in initiate also the and XXXX. complete expansion investigate and solid TRAVERSE trial, exploration checkpoint may immune CDXX tumors anticancer enrollment inhibitors. as other we other or

This relate study. high to in Phase the this the also rejection for and technology to and CDXX and dataset enable a We enabling we to the cells designed Our window AlloCAR resist T during I observed prolonged T were cells. cell immune a CAR was AlloCAR cancer persistence, call cells, notable actively which persistence, novel by that levels that of host cells the use target believe may expand anti-rejection T expansion Dagger. technology can of that is of destroy

CAR all CDXX T-cells as cells, arms AlloCAR targeting receptor, designed preventing and CDXX-positive the platform from AlloCAR themselves, Dagger host thus molecule in cells T deplete a The the on the with another a to alloreactive masking while phenomenon also killing one expressed T T cells recognize known fratricide. CDXX

profile. thus both offering of with Immunotherapy be indicate next-generation other allorejection CARs data antitumor Keystone from CAR that specificity cell, Cancer differentiated a DAK-CDXX As candidate preclinical Dagger combined protection can presented at dual product Symposia, T a the and single capability, in providing, forefront killing cells

Allogene trials, need we This do, is is for patients keenly to get approved we progress pivotal products our us one that aware, desperately who of came our this As at are every what opportunity. them.

innovative everything have therapeutic nothing and that creating the challenge to need make be this we an of modality. new daunting is We to consider exciting others executing what happen, on might than more

will to over I call the now Eric. turn

Zach. you, Thank

brought represented the forest have may Allogene, me has is you have us ability obvious Allogene. of ability have breadth of time, those forward research to inspirational been and for evident Zach who to paths saying been to who and those of through with had team. to you Zach's Zach those the the basis he are. his Zach, help yet meet the I'm excited to for about at working enthusiasm that of as see trees our And what be full months. something navigate we infectious same start the an X brings of the Let on that certainly has who daily meeting past a to is confident already by will development pipeline as that be by to pleasure our

Turning finances; mid-cap and we critical to appreciate responding challenging proud how small value. be weather our biotechnology We we our market, companies, adjusting a is all as to that strong team deliver is a and for to this our shareholder continues challenge. what balance very having especially ability are to of to sheet

critical our key deploy and strategy is have programs, milestones. you all to been one our opportunities of may elements and support As to comments to candidates. forward, of David able Zack, with a discern toward resources highest potential corporate the capital from financial end, focus To the value-creating on efficiently best we our by pipeline evaluate move to that continue to our

fortunate no designed year cash, evaluating are in the strongly in remain debt. pivotal equivalents succeed take our $XXX our In we and in continuing to this, including XXXX, to measures position, be tumors. ending trials; important progress continue and most will order runway. have trial to In the capabilities, a focusing our and believe very #X, #X, cash insight strong million to We on operational we best to cash our the CDXX achieve scientific solid on with for prolong to and investments multiple Phase myeloma; resources these activities, in ALLO-XXX capital We needed endeavors. path #X, II critical we executing financial fast-forward

sufficient expectations, and million cash a $XXX fund XXXX. cash company the to will in XXXX. equivalents Based runway current into in decrease expects The investments the expects on of approximately cash, operations company be

to excludes our of million. compensation approximately $XXX operating expense development any This XXXX full business estimated approximately potential $XX million, impact GAAP expect includes noncash which We guidance activities. year expenses from be stock-based

noncash which in million development quarter, which financials; $XX.X of quarter associated stock-based expense. which year $XX.X expense, compensation. of of expenses compensation full were noncash million for noncash $XX.X includes with XXXX expenses were million which noncash million million $XXX.X and fourth full administrative $X.X expense, includes stock-based compensation for $XX.X research the of $XX fourth expenses and includes compensation year, stock-based million $X.X General includes million, stock-based to Turning the of with XXXX, million expenses and for the

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

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

Instructions]. [Operator

comes Standby, Michael Jefferies. Yee question comment first from line Mr. Our from is or Yee line open. of your the

on we Jenna catch What thinking for to any multiple some share any to And wanted franchise in on have Mike. from latest might And of do and CAR on seeing are you We terms program? is the the when just investigators? CDXX. have enrollment on This real pivotal from quick data the trial? Turbo myeloma, see the up you you feedback for do

going Zach question. I'm spirit will one to Jenna, of answer this question, with the going is just David Chang. the pass question to Hi the and we first

David. Thanks,

study the according So enrollment plan. the is in ALPHAX continuing to

open into are of the enrollment, are the that be outside to additional expanding and year. course we'll over sites of number We expand continuing U.S. the of to the geographies

feedback investigator the and Meeting as investigators recently for goes, extremely up enthusiasm to the catch enrollment. opportunity trial at had far Orlando, for and several is As with in Tandem general an I in high

or of Buren from Our Tyler Van Cowen. the comes next line comment question from

be Given the behind particular, differences? or some might discuss ALLO-XXXA, trial? on earlier and of large prioritization for identical decision YESCARTA timeline lymphoma it's if second-line can the In to trial elaborate I'm know of be the trial the potential the B-cell if and to curious rationale there design that line expected the you to ZUMA-X

Hi Tyler.

position thought moved a second Goldman. For your to that you had

earlier I opportunity. see how about of obviously, we mean, we terms the In an line, thinking are as this

which to very we earlier of very we the lymphoma, the obviously, referring the in even What lines, a maybe doing also one B-cell sweet you're is transparent to or the eligible where exploring And to earlier but line, study. pivotal X-plus in We can maybe of compelling program we terms line. a data are opportunities, spot, is towards different advance discussion. a that that's have already as the a what of different path in are large a population to much sort an

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

for This Salveen. is on

myeloma, transitioning you comment On the stand And do you ? where that discussions? I potentially multiple would then And pivotal? trial pivotal in on trial whether also could be regulatory guess to on

right. All

the just me take question, answer myeloma I'm that to going question. Let and multiple

where into focus. the multiple potentially that In and we our all of ALPHAX are have the year study, putting on us ALLO-XXXA that, is before based myeloma, going the And is are study. compelling data we XXXX terms also really for attention is, conducting, we of a pivotal study

So the XXXX. is obvious exercise study. have that want the all that, for about, study and about ALPHAX as program important option along study priority of just lines earlier that as talking moving the the reasons, to by to with the earlier all design start And the investigators hopefully, line kind talked becomes be we possible. if well, we We'll early potentially goes the with as

to likely that for XXXX. is we the pivotal be out given will multiple more study not Now are brings be -- that -- right -- pushed the XXXX. that where need prioritize, multiple your the -- us thinking for the now, will we to to going we're myeloma question to about stand myeloma potential pivotal It

feedback, whether it's we to process can can, for sure that that continue the at time, we ALLO-XXX. During manufacturing the across process, as XXX as looking or potential optimize different in best we the will to as regulatory make order well which have, we bodies engage assets

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

Do before the that in? need of the updates good process you any dosed for to for be ALPHAX to with And you're enrollment the process track process approval? see filing on patients Alloy getting to manufacturing complete first some 'XX. Alloy in half It's on

to question. Zach to going I'm respond Brian, to your ask

Brian, so currently... the is Alloy

question his process. I alloy think was

Yes. The about Yes, got I that. alloy confused. process. sorry

one manufacturing the discussed length the pivotal the pivotal These yes, that ALLO-XXXA. at this the most forward is study. at that -- we're RDS. to the And the that into in take So process is alloy for both forward process process we of are the the we taking the is -- believe appropriate in trials

and the will process. alloy ALPHAX So all with dosed both patients of be dosed XPAND the in

about Sorry that.

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

something could of question something mostly the Is the wondering are guess TRAVERSE what I this we've or on the to going approach your if have that if reserved Turbo so we Any programs supersede this in is from going what lymphodepletion, entire would comments pipeline? a platform far be that's I'm maybe appreciated? be as And the it offer is about its can this CAR or for even across be eventually tumor you think Dagger limits solid to given deployed study. view? supersede actually. kind today, I seen

-- It's about defines an very for I think it you one. excellent question. thinking how Thanks And much that really we're Dagger.

data the we mechanism out, you technology saw is Dagger promoting data as that is So of by there early TRAVERSE expansion in persistence cells. the the do from which rightly point that a support these and study, the the expansion

Additionally, such data we the that, showing including alloreactive of T do actually a CARs Dagger antitumor also we general, the benefit the capability. dual of host enhancement killing other by capability activity combine with recently the of we cells, killing in see the of targeting both CAR that CDXX the CDXX, when but preclinical as shared possesses CAR

as as products going this hints technology Dagger forward. into So of think these consider that potential expansion the CAR we T I additional

as I the the try or preclinically these in we Now are this complementary, and tumors. doing technologies both technologies whether heme where of approach X think to clinic lots both that replace be as are these solid to Turbo well will explore in may and not, X work deployed,

Our line Schmidt Guggenheim from Partners. of next comes from the comment Michael question or

This is Paul for Michael. on

program? the do need to then Just you about opportunity ex-U.S. the rights to you XXXA. XXXA? one what into opt for are see on ex currently U.S. thinking And for the How

the is that. Yes, Thanks I'll for Eric. question. This take

ALLO-XXXA we historically, know, the ex product U.S. global held Servier on Servier the basis. and codeveloping of you As rights, had were with a

into to provided the rights. us year, out last that co-development of option opted As opt ex plan of the and Servier September U.S. of

option option, yet have that the that we pick pick we up and believe to the potential future. up that have to in We

obviously on a decision of some whether exercise developmental. Our or based will number option and not financials, some we the be factors,

We provide tuned. an on future. the you So hope stay with that to update in

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

So enrollment for about just for question a had the pivotal patient the studies XXX.

want talk are that think Just you're some ensuring whole getting optimally of of on some -- CAR-T outpatient you put about in are the Also, ways treatment noticed reason, of that treatment? for autologous I sort the sort patients concern, could release, that lot an may wondered whatever to not positions a patients the there's that in some therapy, if of for that at press they may you put I patients not suited would normally discretion. your achievement. the receive setting investigator's on

curious you if going sort talk combination and can be between about inpatient? full to to what outpatient outpatient it's or be Just sort going how exactly think of different, a of if of that's as we

John, Zach again. this is

about second first the take outpatients. I'll question So

investigator in a things the quite we've from patients experience out an in CAR cells with community, lot T of benefited outpatient in setting. the of So one dosing there is that autologous

infrastructure is has and to been we transplant And already for bone if so see of the required lot that matter, a handle for marrow established. this that

as for a autologous the on have about infrastructure investigators for therapies patient-by-patient well. our existing basis potentially that enthusiastic our trial are So they leveraging built

that cells not T not products investigators about number are the T for compared do autologous then benefits They our And very not which CAR our as this to know well from know likely investigators quite to autologous appropriately. goes, not -- the that which question and a CAR those have best is know in we've patients patients of products gone But far modality that selecting very first the trial. cells choose patients for well general. be That suited they're I that eligible said, that benefit previously. patients And universally into detail great would they for think are derive as case.

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

to taking do sort that process, different on XXX. when just process? the actually And resuming completely soup the that color some of more is enrollment like and nuts? to think it about it with or love are like might just get Alloy new place, tweaks you process a process manufacturing you for especially I'd Is switching start to XXX the

What process take benefits into we as learned information we Reni, we've of having saying been do have question. just makes the the those let gather understand is, opportunity me product products, and clinics. that from -- not interrogate, not products as the a clinical when the we manufacturing is have really really all clinics. big the manufacturing over manufactured years along, translational taking the into this how the plays out, just to to but the And the data, data the goes difference

already optimize process. development knowledge knowledge sort what of we process using that Alloy the trying done have, is have So is the product, beyond our and that to of we team the with the that to improve manufacturing and process

had into in as right really, reintroducing are back and XXX the products his at for the some XXX the on we So the prepared time mentioned those focus time line now is statement, of Zach XXXX. clinics, looking probably in and

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

the Congrats progress. on

How which take for one early both readout Would the should point, fair us PFS trial a of longer for Just pivotal that on assume but will the while as time think is we out. quick for maybe each read other? CDXX. actually these endpoint, the larger, about single-arm data CDXX? ORRs timing smaller, but primary trial has Obviously, randomized is factors will will out, be primary to it XXXX? trials to offset How a has end read

available targeting in of XXXX. are And first what goes, we at as the time. to of completion we've and half data same EXPAND to is, far ALPHAX availability the both So for roughly enrollment guided have as data

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

study? the quick. want just you BCMA to that which with a products data it of to confirm Just want ongoing? make still program manufacturing to may some then seen pivotal choose actually you want back And of We've XXX. the optimization take to decision XXX is the on these I go to related that, can to

whole a you with see how optimized I team, of about XXX that seen and you know, make decision? data this haven't to now patients' want with before XXX. many David We want to worth just lot would

So many layers of questions there.

Let start the me first with XXX.

to as back already We previously year, said, has small since manufacturing November we started moving of sort also process very process last forward we And the have we're opportunity XXX. further have the patients, for and we of XXX. program of with have into manufacturing number we are the pivotal an reasons, of prioritization reviewing, looking not at XXX X now the in of review stated as Zach

So at of looking up is process XXX an we what both of way, a and to process. we with, believe come XXX concurrently, the manufacturing optimal in manufacturing are more

optimization products So talking looking are what exactly are the we is said, I've we in And as to probably the back reintroduce XXXX sometime about. process into clinic.

go whether early both think will choose one, stay bit I tuned. little In and of we that's or too a with terms

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

process? from and but you there's expect catalyst surrounding bit throughout any what of hoping be I about manufacturing course into any thoughts more could updated you comments Alloy to the I Allogene, longer-term program, would of additional expect the a XXXX? the on great. dive was Do lot little know data been the provide CDXX a there should discussion we And

CDXX on carcinoma. well for updated Jack, Thanks program CDXX do datasets renal our both your question. programs, as it's present in we Yes, intend our Eric. as to cell

to be we and be of So signed up X already we've those There updates the anticipated additional for. at want process from there when other list. that would improvements we're including could those manufacturing course the you year, the if updates alloy programs. as could making are programs, the well, And we that other go we BCMA have milestones the and top as through to of But choose. updates the the on your the be certainly,

question Financials. the line next Our Patel comment from Kalpit or from comes Riley B. of

the Just improvements still process that enrolling the follow-up BCMA on the process guess, not more any ongoing? XXX improvements. is one imply Or I trial? manufacturing you're into does patients that

we as the paused had in improved for work showcase actually we in study at Kalpit, manufacturing construct. back an sat toward process that that the November, event enrollment we XXX

that So correct. is

not the XXX currently I are in Phase study. enrolling We

of or the comment question David next comes SMBC. Dai from from Our line

[indiscernible] I of express CDXX entity? the some expression profile ALLO-XXX, What's T could CDXX-positive Difficulty] response? And a on very perhaps these depth of some the significant on color you Could question on [Technical of And have patients? with profile a T. give patients? you CD Cell CAR the additional question these

David, this So Dave is Chang.

have we have of breaking in those all around ongoing to-date think CDXX X were ALLO-XXX the in And a process. was, have we that we CDXX looking centered there what population. further were And and CDXX optimize is are I who program. expression objective to but was program. with the occurred an seen but patient XX and cases patients In seen, X Showcase, responses CDXX bit, patients expression we have level the difference, positive selection, of response. out that R&D treated we also tumor an achieved expression, at the You make the approximately a highlighted little that ALLO-XXX question up big does And the

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

shortening there's that your time. XXXA I Galapagos time to I between wanted just the of period. X to thoughts like maybe, the have claim given on of X-day from guess, your is the approach days model, -- to X at Ultimately, competitive, may XXXA ultimately of any kind getting a transpire treatment They decisions. a value proposition the get for manufacturing David, as key just to point-of-care

just get less to to likely landscape. for update, a make competitive BCMA that's shift KarMMa-X elevated your going So updates, my the overall, just the perspective an And given and and lines that the to earlier just follow-up, as approach? bar maybe changing here just with for curious on then on

So guys kind evolution of development? as you think and competitive reentering into sort future about it think curious an about play you that is how the longer-term, of guys I'm just earlier bar your ultimately? will into how lines the elevated mix,

All right.

questions X So there.

were angle, that than certainly, to the play role. more as I well time. looking cell could the I product of When at Kite, about future there the gain Let as allogeneic autologous just which manufacturing. manufacturing, the when provides think opportunities, we the therapy, from allogeneic of is sort many a benefit But at was the we're as point-of-care me take mean, ease Galapagos, of

and patients we subjected availability, undergo all site as talking be the You're a very learned, online, availability CAR to not things about also specification, manufacturing as leukapheresis, and meeting the have not slot play to does coming role. autologous heading carefully and leukapheresis which manufactured having these to product more and more products T are

role nowadays, In also aware, one of case, lot, manufacturing that the patients. plays in manufacturing allows think everybody a of treatment lentiviral And is CAR-T. of the also, our many availability I

in progress the it's do, autologous CAR-T. being can of manufacturing. manufacturing see yes, of different think allogeneic the I benefits ways made, manufacturing still what with autologous point-of-care far even So the outweighs But the to great sort

the profile response have the even we what up problem slightly the rate going will access. of proof one autologous matching access now, question mean answer BCMA away have we CAR is go with line, the that think to already that earlier that's already And the that improve I have, of of CAR that the as the I the products. we with beyond main believe if durability T we well. And with and Right not can BCMA problem autologous near I'm XXX, term. T, we

will I quite think we space. competitive the in remain BCMA

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

into levels the On mentioned and program, you XXX potential tumors. for liquid CDXX the going

little more you that. wondering could on if Just color a provide

on as relapsed positive paper kind CDXX a marker. CDXX there EGFR think was recently a patients I showing or of

as on look your kind that well and that kind crossed at? Just of your to potential indications as thoughts play, as of of far curious if

the Raju, question. Thanks for

we different a distribution target think, number of its is of wide a a malignancies. for great number reasons, So on CDXX, including

CDXX this solid because terms of So picked malignancy. high. really tumors versus we think expression of its prevalence of in heme RCC, We is very

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those On the found as heme CDXX. and B-cell CDXX. lymphoma, of having malignancy also side, obviously, on T-cell substantial malignancies, like a lymphomas and patients That's large myeloid in leukemias AML described also of express Diffuse fraction are malignancies expression high well

additional think a to avenues. execute to for in lot as renal continue we us, in the us of I space there's options for cell So consider carcinoma expanding

Tony Our next from comes Group. Butler E.F. or of the line question comment Hutton from

patient This Sorry CDXX. is the be want you versus the CDXX status selection can whether this I selected patients to getting deploy about prospectively about for with hope to potential program about of update will and whether who internal the validation the confusion. able to been timing CLIA, when -- the possible us you development, the assay next of current for validation from it's share the of contain number what have expression?

Yes.

Chang. Dave is this So

Let status answer diagnostic about me the just the assay. of question

developed patients cancer fact, already have assay in renal diagnostic we assay the deployed to the been And used So has the study. to be XXX and the select validated cell in in patients.

those kind for So is done the that's to ongoing. in assay be has work validation -- as with are indications, of all different patients case and additional vitro diagnostic any being used in those

of right opportunities, said, exciting the Zach as CDXX with I said, many it has As dealing most and have one now. the that remains programs we're as different we program,

the additional the queue I'm showing to like management in for turn any no time. over would you. this back to I at conference additional Thank comments. questions

for the of Thank call, about us. joining can are the today. most opportunity We before from call tell all again ever this we you enthused

CAR forward access. planning with about and to the Operator, change role T you now excited throughout sharing the We you for open are look may progress up to our continued are year. to the future disconnect. We we patients the floodgates of

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