Allogene Therapeutics (ALLO) 2 Nov 232023 Q3 Earnings call transcript

Hello, and thank you for standing by. Welcome to the Allogene Therapeutics Third Quarter 2023 Conference Call. [Operator Instructions] Please be aware that today's conference is being recorded.I would now like to turn the call over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer. Ms. Cassiano, please go ahead.

welcome call. and operator, you, to our Thank Today, that financial provides closed, Allogene results press release issued a a XXXX. the quarter after third market for of business update and both press available remarks, This will Q&A a host today's and webcast we on website.Following our release our prepared session. are today per as get to Dr. ask and an are one questions do you possible.Joining to will we our your limit as We to as hour questions many keep me to best to person this call David Chang, Officer; President and Chief Dr. Executive Roberts, Chief Executive we statements. Parker, Officer.During Vice Development Zachary forward-looking President of call, Medical Chief and Research today's will and certain Geoff be making Officer; and Financial These and financial guidance and development product research may of and XXXX the trials, efficacy timing candidate manufacturing and filings, and our planned the capability, of future include efforts, ongoing our safety statements data regarding among success clinical presentations, things. other regulatory assumptions to can These in latest current are that release and documents. information, on SEC risks potential expectations of the disclosure subject forward-looking based be earnings description press and are our statements found change.A

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

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David. you, Thank

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demonstrate When about very approach to aspects and sharing We many about it our trial all with forward I'd with the LBCL.Lastly, didn't our carry more a TRAVERSE are if locked, an solid will approach. we to have treating we ALLO-XXX. remiss our believe address the tumors. look We this of not all about overall be T questions I responsibility take you in AlloCAR to bit intended potential are trial excited you about do talk I Phase lightly

call for CAR have trial and which tumors conducting continued even proud we to this trial. the incredible way As are cell we such, into in understated, cannot another update phase T forum now such carcinoma.The of for advance and and in or Geoff. option a data large are will and taken so next an will this a for over of metastatic solid pivotal now to our approach medical at renal provide deliberate patients early we the with importantly the importance hope target more insights that gain will XXXX.I very potentially we be to community our academic investors We've turn advanced

I chance Allogene? all these years is I've the the simple to covering I as few years weeks afternoon Allogene, I've know is and analysts early forward a get come.In first For getting investors been management firmly and the XX had to encountered. did to I've few to Thank answer. I with now our you, this Zach, handful industry one there speak me, this good of our over question In and months and in of why part conversations, my look everyone. analysts ever and number the of is next of I best one for join believe teams that over a

a care CAR a XXXX companies, to banking, board CFO West now how by of a last as I last done I practice in ultimately member received to of note past when tenure Allogene's the to my the a opportunity of decided gap access years. as Goldman my to Healthcare XX now part regarding to could company in running at allogeneic address play this to number years to move important serve the David, a the a strengths. As quick health a fulfilling from Coast Fast serve of products to with have of XX role me be another to T side I this which firm.Following the from immediately worked team modality.Let this intrigued was I and to my for the Sachs, I turn summer XXXX call promise forward as as at well time investment the background, at XXXX, for in Banking Goldman Sachs the

Our sheet quarter cash, careful our equivalents way third ended a in we which the with cash investments. $XXX.X resources. manage million in balance in We and

noncash expenses cash of net including includes includes were $XX.X stock-based research third was which which expense.Our operations into expense $X.X expenses noncash call, development expense. million of million of compensation compensation XXXX second General to and on our stock-based administrative $X.X share $X.XX on million, were our for per the our runway noted the loss million. As or for of $XX.X stock-based quarter of of last XXXX, based quarterly $XX third XXXX, assumptions, current the of fund XXXX.In expect third half quarter compensation million quarter noncash we $XX and million the

year to continue We in cash, GAAP equivalents for decrease approximately full operating XXXX $XXX expect the to cash and $XXX of approximately investments expenses million and a XXXX be full year guidance activities.With expense for estimated that, approximately includes which million, of compensation impact open the any noncash from stock-based now we development potential This your $XX will business million. excludes call questions.

of our first line going from Yee is [Operator Instructions] question And to come Jefferies. the with Michael

just ask I ongoing of the progress to trial. wanted pivotal potential on the

You things of I you're people's a you just are CDXX minds?And early, sort for XXXX? And and whether types as you are data the are any think still progress CAR not appreciate which countries. Can important or why geographic Can that the give heard there's of the you clarify mix? light different T, weighing some into that terms getting had just competitors blocking did sense you follow is up, then the tackling, you the it's the expanded -- challenges a making you be of that. shed of Maybe you mention and us would XXXX in patients could said on and types other expectation just with that. other of on

line. the Please on remain

Again, on please ladies shortly. begin stay will conference the Your and line. gentlemen,

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still you there? Operator, are

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there. much, technical question the for so Michael. glitch apologies and Thank remember the just fine I you

how well end update, next of of patients really the enrolled programs were are remarks geographies So prepared I'll really in just we're front much ALPHAX mentioned and of excited about you similar as ALPHAX enrollment studies U.S., with now we back.For made in we that always and Australia both beginning.So regulatory are enrolling out the so timing don't we have and progress of the out and we've to patients we all Canada, multiple the pivotal criteria. coming coming have is very I the the types getting to the the set rushing a the we end, it the around were data over again and And years regarding patients Europe.As this shake are to and bringing mix from we U.S. start very we we're potentially the exactly the make second beginning think so so a from not very, a well.And the mix very as question in CDXX, heard, that and to Michael, patient as of and the also XXX, the large then going seriously ex-U.S. focused consistent or sure U.S. from as sort that from then will based few expand anticipate the those the how on in in nice year, with all updating the still data enrolling we keen having, we the and and planning with don't fraction number that we would been question as significant be that enroll just know study on programs on approval year. U.S. towards things. have autologous in are that really eligibility for on first that patients probably pivotal much know I but executing we with a in Europe, from And taking who far far are this

and sure heard data that. just that be everybody's delay expectations. we So make don't the it meets to in you that we expect that Hopefully will substantial want

Yes, That's all good. good.

the have next we can question? Operator,

from Sachs. come going Salveen line Our Goldman the with of next Richter question is to

the Medone Anna first on the a TRAVERSE update for [ there the of any enrollment there? study? then headwinds And progress Could Salveen. ] is this provide just you Have in Hey, an been the Technology, one profile programs to-date? are you and multiple a thinking incorporate given to Dagger what there possible myeloma be And Cloaking on other would the second technology? I guess direction

Again, this is Zach.

as I that we the incoming from year at has that fact in sites say earlier very enthusiasm we've participating actively. announcement XXXX So much in all trial in as the of will been that since goes AACR get far to the And data continuing TRAVERSE aren't enrollment persisted. are communicating interest the the

is options say goes, impressive. And of as that we with evolving, far coming absolutely continuing with really to that we everybody efficacy quite So that's interest can to Technology or back it's I certainly look look with our that to showed that the would AACR, do data can the really the right we level either either reminding as down Dagger pair technology, the evolve that patients in CAR just pair the say you're April right, very ASH and which slim. from BCMA. are Dagger, and show target data that around pretty preliminary that for the BCMA in least.On choose we question BCMA. was patients' to the these And you're field profile for or specifics the that we And second the to does it around CDXX encouraging, encouraging CDXX showed at Cloak have we perspective.And internally, so

to data ] show is sharing that the the more forward [ But CDXX. paired sort coming candidate look months. at of we in far do specifics with as as the next XX we clinical goes So

for of do nice what we proof can very concept with So Dagger. that the is a

of Our Cowen. going Buren to TD with the is Van from next line question come Tyler

I that should, data the aim go end being increasingly which and readout in enrollment next the with I given you EXPAND to And you the will question around the year of ends to used; have it if the would available the of challenged, as believe of talk ongoing that arm? enrollment, being could particular it FDA you by XXX about lack ALLO-XXXA-only if time be the you the same think sufficient? guess up Can ALPHAX my with is and trial enrollment complete

is this Again, Zach.

or trial as patients no far and will unfold. X arms that to so goes, that's the it's obviously, that can So that make the a there, how randomized investigators enrollment choice, as there's

tangible your to randomized enrollment, And one of if they there don't so upon get a patient the expect we because in absolutely necessarily begins FDA, to be that the to a what from will Data study on study be from this that pull EXPAND.And the out in supported with how to the would Board who from that is as go the the our we your also disparity is of at strategy. other, data time the data patients question as thinking weigh second data Monitoring I take do we the Safety ALPHAX centered able mature would reminder, have question when around and about we have is But on -- that. FDA? with be very think it, go replaced.The the part will emerging to of what to and something to same the we're so much part It's we

question the going to next come is our from JPMorgan. with line Brian And of Cheng

the CDXX, stage? resources program you the to us will take before what needed what the for to gauge to stage? Can pivotal bar you deemed preview give early be On push to year on next as dedicating next success program the this be into a will

Thanks, Brian.

in neighborhood already have shown patients. the for, the I in what program to is we're CDXX-positive this as we what of think So looking pertains it

a groups released measurable currently AACR about expression a think had that of recently. range group, patients data low we meaningful As saw what or and for recall more we some expression unknown. offer on be in CDXX that that whose improvement that's you that that positive a then we would of group been of includes that XX%.So of and And patients, the that have group the CDXX response rate one levels presentation was in within was was X and one

that we is around program. path can that we a do towards come pivotal if think a mark, So in

Baird. going to next our from Jack question Allen is the And come line with of

on you satisfied EU? you U.S. build to with in just additional out then providing then And briefly around there? hopefully the you any strategy? expand if locking line some comment it relates I the around EXPAND, was Are geographic and that timing Do some on expect finalizing fully additional to the strategy, in Do territories wondering earlier you and on there? comments first could into that Maybe footprint the have made you comments as updates.

Jack. Thanks,

as still we there. are far making goes, as progress EXPAND So

will to intend the in Australia on bring there. We weeks coming

So we the in to even are still working expand And countries we're Europe, adding the within footprint still sites. there.

the thinking. practice sites what that So execution developing both we to details footprint making say not we're quite we're earlier concept patterns in still for on large is grow But on new share bringing ready for the EXPAND to are it's mode and on study, and we're line so that lymphoma. we say ALPHAX suffice support study internally again there about progress enrollment.And the how then the to will taking to and shape the this mirroring diffuse pretty are excited and good B-cell way I

around to. that guided to on think, still we've time the I details share we're So track,

So stay tuned.

line next of Goodwin is Guggenheim come our Securities. And question with the going Kelsey to from

kind partnership, timing sort qualitative the them or any maybe you Notch of I some I on maybe work process? I guess from then assessment guys been guess doing And provide first any program. regarding kind updates can you the regarding there have secondly you any as and learnings update the strategy? that iPSC guess, kind specific manufacturing the with could the you of there is to give BCMA of of maybe

one question. David I'll and Notch first the -- Maybe the will can take take and you take then Yes.

elements in is examining not are into program learning we learn think the company manufacturing across process BCMA we programs, translated optimization. I that program are one that another. won't BCMA. portfolio ripe are goes, go the I into learning side there. as manufacturing the -- can what many But be our is of Currently, far patients as I are into obviously enrolling to the on say, we sort there what as So specifics I for every are still the times can we're still manufacturing those that process.What And are we T think CAR that do we

that making So we of progress and are quite clinical on context we're excited manufacturing about the programs. sort overall understanding the other BCMA of within our that

our question, second the in David CDXX made on working cells. is CDXX and And we've differentiating that, the been differentiating positive the Kelsey, now stem cells X progress after Therapeutics They for in them have So iPSC into Notch partner years. this subsequently iPSC into a the with Chang. area. about is tremendous the

we -- the progress is continue we are being team to the it's into handling stage But with made longer. what all working work to at to that we going now, very technology a bit So things and are closely stay are to think I given incorporate that the Notch doing. research for little

And is the from to line Genuity. come with Newman going our next Canaccord question John of

I used wondering as able enrollment? EU, trial. Australia, not with sites Ts also of are to the a been Canada or allowing discretion. sites and wondered be widely this trial, patients autologous where you're treated I'm have outpatient U.S. just clinical the help number CAR I to CDXX versus treatment if the clinical on question for the way. for at ALPHAX substantial investigator's you've enrollment, I'm the wondering you open the the if to a expect in available

John. Thanks,

I'll maybe the question second answer So first.

access lifesaving our or getting countries all reimbursement-related that for enrollment long many are part therapy. for strategy expand So that where can reasons, where why not kinds patients reasons different widely autologous be is and this is those has used as access-related, been we're encountering of of to into not of product to indeed sort sites geographies, clinical and

to physicians. or such having those is clinical welcomed the access in So and EXPAND a by trial as really ALPHAX the cases quite patients heartily by

on question. first your I'm John, sorry, blanking And

Outpatient.

Outpatient. David. Thank That's right. you,

be outpatient of many met fully first number I with position.Of level can in reasons, the patients say CAR have managed being to But would one talk centers these So some we to them that if lymphodepletion be their infusion. their needs this. so well to the of they're course, success other of been high or are centers as admitted. problem we're the both a in how patients very teach some no have the that a outpatient. managing in to be -- are seeing for has it come and actually more default patient around enthusiasm actually And patients fair try fact, far that and encouraging all, means them patients that's T to as And few continue managing having of a there seems at centers to

does outpatient. interest a to seem there of quite handle high to So be level this

of come question is next Patel B. line Riley. Kalpit going Our with to the from

on Fleszar for Andy is This Kalpit.

alloreactive allogeneic please One Can of of CDX+ that be elaborate CAR could your on in ASH cells T abstracts T ways you the potentially addressed? recipient impact rejection. this revealed

question. Good Sure.

I So think unmatched we've from known patient, -- take known donor that known a there. risk field that allogeneic is you product the allo-rejection the T HLA certainly of an CAR into developers other is a have when and as

really window these I showing in host versus crafting further I I refine got What both negative CDXX is prevent to we managed paired versus ALLO-XXX graft but help think graft or strategies, also see ourselves Allogene used far for selected folding robust so response.What a actually, persistence exciting the is strategies as that our around when think mitigate And so around on strategy clinical and component everybody into entirely managed that's that and is remission. of and is levels that has an is to quite versus ways product and what is how that mitigate corresponds to expansion strategy, -- think successfully we've development and looking a targeted rather I that something or with say LV.However, we've this engineering and to that have relying far, we're graft data cells, is complete reaction. how grade and for gene from durable where them CAR taking not we to will would of our that LV T those can create so that through show host other this this just lymphodepletion our persistence high new we abstract host can done learnings lymphodepletion

new forward product development. we're that is think So But probably that point track. of our learn right is taking really there's I that Allogene on can that more abstract the and we the into

come Corwin William And Blair. going our is line with question next from the of to Sami

the Dagger think it's a syndrome. was there in that's to and if a cell you you cases could if it if changed what all lymphohistiocytosis-like the Technology the [indiscernible] And on guys elaborate reported at data noticed that that wondering XX-Q were little some for that effector related bit. the trial? of immune I was I on guidance

Sami, for of mouthful that with a And question. entity. job nice Thanks, new the

products.And in ICHS that an it's So umbrella described both that heme is probably heme the solid programs, we're described but likely in been tumor our is across an that programs. thinking CAR term programs, not [ other process fact, it's as inflammatory seen well likely about T has ] way as, others

have an to this opposed sort see or we CRS XXX dose little I we to so bit a more want we straightforward sometimes as the be to description comes we call escalation. use.So are or when HLH response through want think inflammatory to ICAN, just careful it that moving we ICHS of when And different is that to as begun this just to program, reiterate how

the solid the probably this T. so for T, best of is that CAR shown been data especially I tumor some ever And has AlloCAR -- for really an believe

And that so be careful we toxicity we any when are expect. of moving to the forward, expansion a sense we good and we emergent we that want what to get so to as cohorts, mitigate have

is question the next come line our from of Oppenheimer. Hartaj to with And Singh going

your follow-up, program, marrow or BLA bone would sort a with relative couple commercial program, are LBCL? in but clinical that early pool is patient Are transplant on line where a of probably year, of questions. sort with into are you'd little question one you that you got the there I move secondly, technically third on is, seeing in that things over Gilead a of, just in is the your CDXX patients? process? in what up Just line that material second more of more for lines bit therapies those be a patients the in increasing, moved are just therapy?And changes to be of broad XXXA, file My something process, last changed Have is your LBCL, imagine example, then still material you able lead meaning to have for as that? autologous are manufacturing

Yes, Hartaj. Chang. This is David

he break because been question has So let question. bit me of little Zach after a give answering

how early our of lines Your first and T the autologous question and about CAR affecting XXXA that's program study. approval

in something as with ASH makes abstracts both a today's of CAR as BCMA from this in is this I abstract earlier myeloma program lot CARs. expected had CDXX taking think, point, -- sort cutting T the multiple well the certainly, line. in -- the into the it are the that the that targeting as we of a way seeing announced And we

the -- changes ALPHA/ALPHAX to the line we is not is reasons So in of are access the XXXA a this number still trying ALPHAX that are is quickly us for patient study. CAR lymphoma. kind a certainly segment that the who fundamental second in manufacturing, while study, that for in the of open terms really still the tap really commercial flow we our non-Hodgkin's as move The as are And patients just possible that support we large are using fact the commercial we this changes could multiple there's worked the something that have for witnessing of the to address launch. earlier into be and potentially that one to about will to that myeloma to facility T.So are of And the launch. as we is question in expecting manufacturing is on it process basis a area.The CFI getting

yes. is answer question to the So your

from line And RBC. our Luca Issi of going to the is next question come with

those and And timeline of align is This of have would out? EXPAND for sufficient if Lisa read you ALPHAX when for you with Luca. on would readouts? runway us data both that could remind the Can

Zach. is this so Yes,

at to data We of have the the are year around first expecting time. next the least and our expect data at look same the we by end EXPAND somehow some -- ALPHAX of some

it, far X those as that let I'll readouts. but the we beyond data highest speak the runway would do goes, have extend as to others at yes, runway level, So

over I And David for would now back like to to remarks. Chang any turn the closing conference

Yes.

in us ongoing you allogeneic for thank your T. code for joining as today we the So CAR faith Allogene create and

our validate Operator, And look forward you ability for months. We will sharing you pipeline our your reality sharing patients. important disconnect. advances belief a to to coming to everything over now make with may the across in do possible you continue to this --

conference for This Thank call. concludes participating. you today's

You may now disconnect.