ALLO - Earnings call transcript Q2 2020 | Allogene Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to Allogene Therapeutics Second Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be aware that today's conference call is being recorded. to Officer. call like Cassiano, to now Communications Chief would turn over the Christine I Ms. go please Cassiano, ahead.

Christine Cassiano

operator, you, Thank and good morning.

Before available press today's being website release website at and Allogene call press release issued is a XXXX. We for on June today, will the and update our available ended for financial market corporate our results remind This webcast quarter XX, www.allogene.com. replay. on is that be opened provides second a listeners that

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

We locations. continue different to calls conduct from

appreciate should So your technical we patience difficulties. any we have

These in and of made uncertainties regarding our risks success to capabilities guidance, regulatory efforts, are information, XXXX. During Exchange Form assumptions things. today's call, in and that and ongoing and quarter we involve June the risks the those results our filings, ended may statements. including on materially cause statements XX, development These financial current with forward-looking actual will trials, statements. include forward-looking the and future the may These be may data timing manufacturing planned expectations Securities subject change. to XXXX described forward-looking contained filings These making are clinical and differ and presentations, based are other our research Commission, statements that periodic from other and among XX-Q for statements certain

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

David Chang

of for as conference few our you very and Good second we morning, with ongoing unveil us allogeneic data clinical The first to Allogene with presentation very and we months findings our last means AlloCAR Thank trial it expect with paves way call. what that initial ALPHA data ALLO-XXX as into trial were as joining exciting our data the I in for for portfolio well potential the We was part tolerated lymphodepletion ALLO-XXX development the for ASCO. Cell-Associated no pretreated been you, Phase initial disease advanced it T the Christine. Effector the thank the toxicities, pleased from on at a non-Hodgkin's have from quarter platform of Syndrome ALLO-XXXA, graft-versus-host II Phase lymphoma. Immune a ALLO-XXX XXXX. include in or regimen patients Key dose-limiting from pivotal with which our enter Neurotoxicity with heavily

rate. a ALLO-XXX, complete of a believe continue had that partial eight received of T higher anti-CDXX who to dose dose trial We response Of XX-milligram, supports achieve ability important patients our response in AlloCAR the antibody, associated to of higher or of the with four higher being from data promise the ALPHA achieved remission. Initial with will components a or our strategy ALLO-XXX a XX% therapies. be and complete a XX% one of ALLO-XXX the our five

such patients respond in be is oncologists, XX-milligram of I to that learnings this to believe the I of those lymphodepleted patients type to exception at to out In on histologists a one CAR-T speak multiple ALLO-XXX, as are are being assess identify who dose and have across the patient came that suggests additional response, in we therapy. resistance. dose-escalation characteristics, While ALPHA initial response of of the this data with of Phase tumor the important the respectively. ALPHA understand all it study. worth follow-up are we science intrinsic XX% data was as is data await can not. a ALLO-XXX to doses the potential might refractory explore I and couple a ASCO, it therapy baseline observed review durability CAR-T-naive noting that, have patients XX%, resistance underpinning from complete a CAR-T of overall to presented Across well, and the rate the Initial autologous beyond critical activity and we meaningful previous from of in what keen and to and patients and patients the especially expected do Rafael may for the who which ALLO-XXX, the anti-tumor

comparable autologous are from CAR-T follow-up limited, to those trial. these was Although efficacy data reported

readout was XXX of million ALLO-XXX, dose this progression, may the time data was to of cell of of study complete to we retreatment which Early what cells cutoff. lines This achieved time, deeper ALLO-XXX case had partial with patients. patient lymphoma, very stage dose male on-demand led be been after XX-year-old and is One initial allogeneic the progressed with and exciting ability of He he the this one of refractory ALLO-XXX. the cells days. treatment to a a remission, redose X and a with another enrollment treatment and a XX-milligram response at gave a therapy. X, five experience achieved peek of XXX Lastly, at therapy, response XX-milligram presented Overall, benefits month was ongoing with month start the to the ALLO-XXX. His small of has T follicular us Shortly encouraging. X. who most million first prior retreated but AlloCAR at as with treatment average of a been patient three was from redosing

to our XXXX. we trial utilize a a parallel ALPHAX great standpoint, II in benefit ability are this efficiency studies believe this as We While done investigators advisory of terms pivotal the our we, to enviable there an Phase for with position as ALLO-XXXA ALLO-XXX inform to proceed to exploration we outcome. redosing, From trial. is potential ALPHA we board ongoing of our the scientific plan ALLO-XXXA potential continue with clinical in optimize trial be in to with excited for an are in treatment still understanding is very much and along

our broader to patients ALLO-XXXA recall construct T rituximab receive is to removed therapy. which that anti-CDXX domain of AlloCAR recognition been the have population in allow will in order You a

to our abbreviated pleased are We escalation dose report are of ALPHAX. that successfully we advancing

completed a now XX-milligram lymphodepletion patients and more level of in X are dose dose the with have design using fludarabine and ALLO-XXX and ways will we in on ALLO-XXX. to cell cohort also the details cyclophosphamide in have is universal higher has continued strategy the provide similar We in BCMA. UNIVERSAL The combination with of trial. dosing Rafael ALLO-XXX design many dose with cohort. what of ALPHAX targeting of Enrollment done trial trial the cell

higher doses which of continuing is different to that lymphodepletion portion The cell dose-escalation doses, involve study evaluated ALLO-XXX different dose We regimens, three of have treatment expansions. ALLO-XXX. recently completed utilize UNIVERSAL the initial to patients and those additional of including a evaluate

to meeting. Our at initial quarter from a fourth remains plan the data UNIVERSAL present in medical in myeloma trial multiple relapsed/refractory

made Hence, localized believe is cell renal the well this nephrectomy. we an we such known in and have with tumors. our as cell undergo platform, are and makes treatment. we to could as glioblastoma adequate target. particular, cancer CAR-T to various progress safety, it be to CDXX review T the which renal immune-mediated carcinoma our Lastly, in potentially we anti-CDXX cancer, expression about breaking exceptional for RCC, for and enthusiastic candidate Patients across hematologic as being with tumors solid increasingly responsive responsive can AlloCAR found solid preclinical malignancies, lung as therapy. down potential ALLO-XXX, the be

However, metastasis XX% XX%. to developed of less XX% survival to patients rate X-year median the a with XX% than

face the come carcinoma environment. our plan be renal in cell of been become home While from to excitement this patients progress employees. renal industry by checkpoint year clinical cell rapidly end in norm to this to Based and our initiate most this therapies for targeting in metastatic in a continue we'll XXXX. patients a disease. have treating carcinoma challenging an there have on external with activities for program, of many with has and filing we manage Operationally, treatment-resistant of ALLO-XXX, VEGF pathway has Work a a progressed our IND trial we inhibitors, with the

and has those teams have preclinical on-site our allogeneic We be thank engagement to to difficult I our times. our therapy advance like major the and their benefits have cell reliability, who all employees of targeted. during dedication space work be that need and to these of This so lab believe for We programs, can of key us goal malignancies continue had to Allogene, to closer autologous so. we convenience, at in would success allowed scale moving while breadth our follow providing also are ample to clinical do and grouped time, for therapy, to CAR-T

to patients, to stage autologous midterm. for advance aspects our AlloCAR how Our progress platform of lymphoma the including the mantle our near for term, in beyond path a term efforts T refractory ALLO-XXXA. approval validate we quickly including anti-CDXX for expand AlloCAR therapy, served making are candidates indications AlloCAR ability therapies T multiple might in sets to Longer recent CAR-T of relapsed the the to T our and forge cell

and serve to our innovation updates as turn the of I to Rafael forefront modality field their important next-generation many work keep And the and look efforts at our further will continued therapeutic in we for patients progress research potential to we the over to to us the this has these transform activities. team As therapy, cell of identify expect call tools need. now on development research technologies. and

Rafael Amado

all an you, the within who our responding initial histologies, median and overall X.X the cutoff. remained rate response XX% analysis session in are large CAR-T patients autologous complete Responses was these None are XX XX% at patients and XX% from a Included XX%. staying a report was I prior David, AlloCAR CAR-T were in data response best was for and X safe. expectations. their an and I of rate of observed to the patients B-cell lymphoma in naive until the of from Thank cell In ALPHA the May hope patients, data across With or therapy. T with extremely months, tumor progression were CR Phase of efficacy responded to refractory these ORR The months. all X lymphoma, to follow-up patients rate I'm follicular the our XX%. meeting in nine ALLO-XXX response of you disease presented that doses ASCO exceeded response and oral virtual pleased overall diffuse trial therapy.

a higher host and noted, dose neutrophils and T platelets. David while a deeper XX%, As recovery, complete sparing was cell associated of ALLO-XXX response higher rate lymphodepletion delayed with

was who dose of month of ALLO-XXX. patient the David to ALLO-XXX, after I response responders a referred PR ongoing into with patient same context. earlier, retreatment data complete the initial this was of would with a dose to put two. One like XX-milligram who achieved This that an a a progressed by now

number lymphoma median XX and patients regimens therapy. was a The of Firstly, diffuse defined poor. activity We by We XX% the signals Phase subsets. the B-cell regimen able were mix have of done This of pretreated. enrolled I the follicular population stage last months or X to within in refractory progression much in treated gain disease, as both was XX% and possible lymphoma information X was heavily to study. stage as XX as of collect patients to this large of patients. clear were

a from may in ASCO Phase studies. from our number but to the analysis in our analysis the autologous size, point. may II point results published our of from other time make possible this direct with we autologous ALPHA results rates similarities enrollment be early development, recall investor juxtaposed with this composition, response CAR-T showed not between that CAR-T CAR-T. to of and that what rather of study meeting criteria and varying of a patients AlloCAR-T at initial range that this illustrate The comparisons was The You the study's parameters, clear naive data

and expansion; address, need we initial more questions to be times, believe ALLO-XXX can provide clinically yes leads without be answered ALLO-XXX be lymphodepletion ALPHA histologies. aimed administered ALLO-XXX trial we manufactured; associates to experience complete that While these dose-dependent ALLO-XXX safely can administered with graft-versus-host causing and have disease; relevant namely, successfully it and promising to that ALLO-XXX confirmed safely multiple can responses across the findings several to follow-up important patient with will longer can be

outcomes protocol to as CAR-T these not to optimize understanding able redosing, improve to continues respond patient be how with may to patients current we Allo the how in Beyond questions, which gained may we've lymphodepletion. and also important therapy, which

I/II We data opened for outpatient ALLO-XXX we the addition, the In Phase including be ALLO-XXX patients. potential setting. explore have follicular dosing Meanwhile, lymphoma. non-HLA-matched an demonstrated profile or large must XXXX. look ultimately these a anti-CDXX to trial, relapsed/refractory possible safety next Patients early promising XXXX and platform. in patients late open-label readout to single-arm, by Patients adult ALPHAX ALPHA monoclonal ALPHAX study B-cell is our up two to what enhance the are findings actively therapy which may forward of least in Overall, therapy, multicenter is be anthracycline enrolling with from with our ALLO-XXXA in received of study an prior AlloCAR-T and expect at the antibody. enthusiasm with excluded. lymphoma the lines our

While two doses ALPHA is to kinetics, prior cyclophosphamide ALLO, patients of from are escalating the of previously CDXX in meaningful design of and responded dose and experience is a XXX enroll duration fludarabine. cohort a depth patients replicate total remains in autologous and ALLO-XXX CAR-T trial. autologous pharmacokinetics that tumor the from positive will certain ALLO-XXXA with had abbreviated of We're autologous ALLO-XXX We X-plus-X the of level flu/cy. dose secondary level and CAR-T cells, autologous CDXX-positive follow with initiated ALLO-XXX, objectives considering using with response learn to of more cells. lymphocyte milligrams of include the objective Allo patient. treatment. who whether ALLO-XXXA as therapy the if outcome XXX we administered at a CAR-T ALPHA CAR-T with cells, a single million will Key ALLO-XXXA CAR-T enrolling million about we X study XX a study cohort to concomitantly therapy, who corroborate host The trial a million XX to the patients of combination Phase cell and was tolerability trial evaluate safety dose primary of patients findings a to Allo to aspects that The dose dosing cohort The of depletion.

Phase the in to We of into this target moving portion XXXX. study continue II

treatment Allo cell for Anti-BCMA Our therapy additional our clinical relapsed/refractory focus CAR-T myeloma. is multiple the of

ALLO-XXX We our fourth to the at ALLO-XXX, quarter is I track designed million, components to explore receiving XX and the study of X-plus-X Phase the UNIVERSAL, all this million have are with trial regimen, X lymphodepletion XXX ALLO-XXX X and a underway, this from with million patients X-pronged XXX initially cells of BCMA. on in fludarabine cyclophosphamide optimal dosing data initial clinical strategy we targeting of dose-escalation in including a was and doses: design. of well report This year. trial

the XX of cohorts, milligrams cell David As rate. noted, the UNIVERSAL lymphodepletion, death assessed enrolling disease residual and other being ALLO-XXX including and tolerability, are initial portion endpoints we using completed minimal have dose-escalation of expansion which of in trial safety, activity, recently duration and lymphodepletion admit fludarabine. The antitumor

doses multiple and Given regimens, explore patients disease of myeloma, complexities the we both disease propensity for to lower for excited progression with include higher ALLO-XXX. which this and of are

optimize as forward novel look learned need therapy to we lessons to our redosing platforms, all for also of patient We treatment. ways in evaluate population applying the such across this as

secretase myeloma. discussion our with echnology exploring the best to therapy SpringWorks strategy BCMA how call, our we of platform an ALLO-XXX the with CAR-T Since use CAR-T combination gamma prongs have advanced efficacy on of anti-BCMA inhibitor enhance our include secretase and regulatory of combination inhibitor, from last of ALLO-XXX the investigating two to Turbo earnings other nirogacestat, evaluate our the in partners Therapeutics. The potentially at a gamma in a

exhaustion. dose viability TurboCAR These ALLO-XXX behind in solid support malignancies treat requirement to clinical to this hematologic to IND properties therapies file could candidate. CAR-T potential be expect breakthrough tumors. CAR-T and Allo enable the and The cell our and a of efficacy first will combination reducing We an technology may overcoming harder this TurboCAR CAR-T while to clinical year. has this as cell innovation expand the evaluation be

could versatility become of believe this the XXXX. TurboCAR allow could about cytokines. technology a we We Allo of an anticipate we presented echnology. The for May, what Meeting CAR-T our And may Society preclinical AlloCAR-T are platform. findings and At next-generation in excited technology mean this Therapy to harness in and the Gene IND of for for standard therapy us Turbo Cell in American different submitting CAR-T myeloma on eventually Annual signaling multiple ALLO-XXX

ALLO-XXX, clinical research teams As progression activities. teams for our preclinical ALLO-XXX, progress focus and our ALLO-XXXA clinical on trial to our continue

on preclinical hematologic the use to of traverse look from cell Our solid our candidate, we work ALLO-XXX, therapy malignancies as tumors. anti-CDXX continues into

is end planned renal ALLO-XXX the by the potential other IND Our malignancies in this of the treatment-resistant year carcinoma with to cell study in future.

FltX cell candidates, addition such as AlloCAR-T the for novel such earlier investigational an preclinical as our treatment program. stage therapy In work stem a above, acute well continues leukemia targeting on induced myelogenous technologies, pluripotent to as as as ALLO-XXX,

our in I are pipeline. at by to to pursuit the strong across both therapy achieved to CAR-T congresses. scientific and forward preclinical bring updates are and excited relentless momentum provide continuing to very clinical we've We Allo patients look our

leverage While will as to we pipeline externally our we to we and review and call turn internal over like continue capabilities innovation our I'd Eric advance the to to candidates existing partners, now financials. technology. next-generation additional also pursue

Eric Schmidt

Rafael, you, Thank morning. and good

was of Let offering of deducting figure patients. the by underwriting payable from is thanking offering in of CAR-T shares the the additional or existing common all that many new later prior your in by replay, for me bring start June, to discounts, raised this by recent our stock. shareholders. and purchase therapy those Allo exercise listen on of full proceeds In the closed in to Included underwriters expenses their and we commissions gross $XXX.X us. follow-on a million in option to benefited efforts Allogene which our to may participation evident in support who financing, the particularly ongoing during That to support you call of

second were equivalents and and includes our release million stronger the and In and noncash million expenses were of as earlier June for ever, As issued development position second a than noncash which million $X cash General research billion of million, $XX.X stock-based quarter expense. our $XX.X XXXX. today, investments financial totaling the included XX, expense. SEC is press as compensation with $X.X quarter, our $X.X cash, result and noted expenses filings second stock-based XXXX, which administrative compensation of quarter of in

in expense we of to our $X.XX million. for stock-based on am manufacturing noncash of our Newark million remain the of continuing that including an that experienced as was our open and loss result bring $XX for force. to the manufacturing million delays between for we and only losses impact full facility or online Thus second full will be maintain million estimated net $XX.X We expense far, from XXXX. a million share compensation to $XX pandemic, I build-out pleased the we $XX report development million, Our will now call track in the excludes per have non-cash potential that, With quarter XXXX your is facility includes of compensation business minor stock-based XXXX and expectation year which $XXX questions. an net activities. $XXX any

Operator

Thank Instructions] Phil first you. with Our from Cowen [Operator and Nadeau question Company. comes

open. line now Your is

Phil Nadeau

escalation data possible to is that from cohorts? UNIVERSAL morning wondering for us give additional by ALLO-XXX? my likely expect Abiding the initial we bit a what get one-question you taking detail if I dose QX question. from with could on the just XX-milligram from the thanks release it more trial? the rule, and portion of Are Good was could we from the data that we should results see Or

David Chang

I'm to question to weathering I that the storm all, going the the asking things who X, data I expect part of So getting it the good better. Rafael about Rafael? for XXX those presentation has for to well. at hope Phil, details. that the the hear refer year-end, answer The passed east to and and what first you're in morning, are coast are

Rafael Amado

I David in as that and X. remarks, at have the dose mentioned so was escalation, finished initial have, the X DLT. We didn't plus We mentioned any

patients The as put ASCO make at treat number some we of patients, well. total of cohort will We remarks, my will in patients, is still end be I of idea that mentioned number also into thereabouts as I can the it that. compare presentation there year would some an the you think how XX the a in CA patients what milligrams. And so but many we to if be to similarly get presented you at determined, probably

Phil Nadeau

you the data an the Can will release? be follow-up. us – the one of just that of in give duration for initial idea maybe follow-up that patients And actually,

Rafael Amado

But will million to the who but Obviously, be, the to much the I now. patients come have will do follow-up know. that's that with number at that we have the think I We we difficult started doses. You calculate it's at XX think have analysis. that number up what will don't right than once median later started the patients longer a have follow-up a

Phil Nadeau

progress. question taking and all Thanks my Great. congratulations for on

David Chang

Thank you.

Operator

Richter you. Instructions] question from next Thank Sachs. comes [Operator Salveen Our with Goldman

Your line now is open.

Andrea Tan

the for still to Hi, David, on is XXX for you Salveen. with the where be everyone. lymphodepletion And optimizing just stand some taking needs Thanks maybe on for thoughts the what question. trial? do This Andrea here? done

David Chang

In data I the terms as lymphodepletion, already longer-term so for very to dose waiting was the we are And XX XX of at mean, milligrams. follow-up. obviously, the short, follow-up increased ASCO saw we encouraging the ALLO-XXX of optimizing presentation, from we

while to see ongoing, ultimately we just what really can this perhaps why different are have do doing do testing a because two cell can quite the therapy trying can have allogeneic So at ongoing, we of do. end, great to opportunity to but that's and few autologous we getting more. And heading situation the therapy studies additional cell unique also that's we

little rate we treated the the right the XX of a But patients saw is So with follow-up more. bit of ALLO-XXX optimize higher where we of remission. continuing focus on are to are main complete the now, milligrams who

Andrea Tan

Thanks so much.

Operator

you. Thank

from Jefferies. next Biren with Our question comes Amin

Your line open. now is

Biren Amin

question. for Hi, guys. Thanks taking my

XXXX. update end in out but data next early a for window the ALPHA the year, also that may said come there's from of the at you think I So reporting

to timing the just the that the ALPHA are what understand, update? factors driving trying So are for

David Chang

to ask going I'm So Eric? to respond Eric question. to that

Eric Schmidt

Biren, David. thanks, Eric. it's Yes,

meaningful presentation sure and initial that our set, really ASCO want with updated case to informative. is the was an be data As we

a the of As presentation. months you couple been know, ASCO just since it's

And to provides the move patients. enroll meaningful form study opportunity an that continue at scientific we'll look patients, for additional the we'll forward, update. that time, ALPHA same a follow showcase So to

or – in we we or as mentioned just either this late next, his plans quite that decided Rafael could early our really script, you yet. haven't As be – mentioned year but haven't

Biren Amin

question. Okay, my great. Thanks for taking

Operator

comes Cory And Kasimov you. from with question JPMorgan. next our Thank

open. line now Your is

Gavin Scott

Hi, good Gavin is morning. This Cory. for on

So I bit nonetheless. be interested acknowledge this might a just thoughts, your in premature, but

Given the down to what mitigate with steps CMC scrutiny are therapies, on the auto some early other of respect players, speed evidenced of cell clinical from and bumps the CAR-T – in to gene CAR-T some as potential can the you take today road? development

David Chang

question. improve test take into are are a we manufacturing analytic of as And So into cell the is And proper down a the the that's develop to lot me certainly includes to that both carrying as as complicated. that we as that that in continue certainly CAR-T according let allogeneic, little of qualify the more taking release enter we the assay did when are test all attention. release material that the this and are area what we autologous the of bit CMC development I We therapy assays consider through we mean, it well a involved an say, I is, necessary to where explorer that we would paying manufacturing to additional so break really and necessary. can how we the regulation. care

expect. still the facility kind premature in ensure our is needed preparation any are BLA but the manufacturing thinking the part a of That that equation. we already, building the teams can pass part one the sounds out just of to things preinspection filing. are facilities when other bit little of Newark, manufacturing are in ahead And which that's So we

answer that I you into questions sure that that every can we the come may address to mean, we of any possibilities can have, tell make with we experience that can kind up. I So much. looking are I to extent, but that regulatory

Gavin Scott

Thanks color. Great. the for

Operator

Thank you.

Our next Piper Tyler Buren Van from comes Sandler. with question

open. is line Your now

Tyler Van Buren

during the congratulations morning Hi, quarter. guys. progress Good on and the

we out durability relapse-free you great. durability that in KOLs a thoughts that was updated at the on months. the are saw And nine rate the your And out rates kind response get rates three that ALPHA non-Hodgkin's, and months. to had most to response two response to say with of the wanted to response responding the get clearly, of out for of at one as what and Just future, overall ASCO. of trial to median CR we XX And those years, XX% XX% patients relapse-free X.X patients think with

you if five are of is I which XX% them about three see XX than that data months XX that's So mg eight even those of more to at to kind guess, relative before mg, historically the and look still XX% responders, that XXX of eight made responding, out at and dose. it XX% we've you dose, seen,

important when look of point think about durability So I particularly as the we guess, would you time months kind rates? at guys agree with those comments response, longer-term that KOL X relapse-free made is we

David Chang

year And especially following autologous the to seeing, coming they are are and and Tyler, continue year encouraged be question. data what the by three. thanks we the durability for certainly, from two

but we data complete cuts. be we I As to months point mean, a what really haven't of of in X. durability. six mean there first and very And study, is say, six in between time of at the well you month durability I plus, month with continue correlation to good as longer-term the than high our point are who would remission gotten at response we the that as people seeing I certainly, the out, are encouraged rate

encouraged cutoff, presentation, saw see we are we And follow, very of we by go we and durability look updating highly is out, how because data holds to data ASCO But to it future. near where important. at as up to was the durability you especially So relatively in the the will the forward XX-milligram what short. we where

Tyler Van Buren

taking Great. Thanks the for question.

Operator

Thank you.

with Wainwright. Chattopadhyay Our question H.C. from next Debjit

is now open. Your line

Aaron Welch

call. Hi, guys. is for Good This taking morning. Aaron Debjit. the on for Thanks

other So a you redosing? to looking patients of is how for do need you do with question that only see s. redose? that to prior clinical you previously or there to I ask that? points treated relapse settle for biomarker are kind CAR-T Allo you wanted What And – redosing about have been Or

David Chang

to Great ask going question. I'm your question. address Rafael to

Rafael Amado

Yes.

addition is accurate So classical responses, and this what will because patients I in predicting innovation in much area response response more patients remain ready molecular in can the assets of think there to now for won't. that's long-term are an terms of that be predicting really which X being months, in

have So in and allowed respond in redosing moment, and is progress, and that. to that are our redosing at prepared talked we the about that we protocols, the remarks all and do patients we we continue example if that

I think the XXXA, is the things in for are dose still what is really we while XXX, experiment like being that with redosing. fact exciting to we're able escalation doing

now number of they or a And upon results, whether really lot in so for autologous we improvement. improve which, being are XXXA of although a redosing patients not room to the see in still can is tested fantastic, broader there's

So you the in other should future. in patient populations see redosing

Aaron Welch

Okay. see data year-end or We redosing? may on at XXXX, this early the

David Chang

progress the certainly, a early that interested response, given patient that consider for site. we we that's clinical allogeneic And or opportunity studies, cell right the one redosing, when year. in. it's any And the products we redosing. to be availability or redosing is a receive are other meaning great the patient, when ongoing opportunity therapy, you update give We'll additional that they area, now data in as mentioned, had of the It's next collect, quite can do – the reactive what good not just achieve whether a as cell to an provided the Rafael aspect, we with year-end they the a

Aaron Welch

Okay, thanks, Dave. Thank you guys.

Operator

you. Thank

from with comes Mark Our next Breidenbach Oppenheimer. question

open. Your line is now

Mark Breidenbach

and question. taking good Hi, my thanks morning for guys

the antibody treatment NHL either the CDXX of for general you [Technical CDXX new have trastuzumab? CAR-Ts auto in Are or a make who Difficulty] performance any with entering wondering precedents comments can on had Just there ALLO prior that? any patients

David Chang

non-Hodgkin's available Mark, become thank to much response. going you to provide excited very question. are patients to Certainly, about that ask continuing for I'm therapy we new with the lymphoma. very Rafael for

Rafael Amado

we that way those I And a also development are I product. new constantly in may fantastic in need both exemplary both sequence know, of history types others think coexist. be obtain coming treatment, population. we But think in that And that cell you expect comments. product was, may which they the versus, patients notwithstanding. a eligible and it's as therapies Yes. be bispecifics that they echo the therapy, as I think, stem and I to mean, cell said, may will with medicine and combined. are there's onetime therapies, label of also given in autologous Antibodies that be a redosing I

these therapies, benefit physicians, overall renal other investigators think will a cell what for – of cycle types myeloma, I in what in patients. happened carcinoma, to the – So like, the way find countless tumor happened

So approval we're pretty happy that actually place. took this

Mark Breidenbach

But no CDXX received information about a CAR-T patients antibody? post-CDXX who

Rafael Amado

will that – to I the think to are able well enough be respond they the need of as mean therapy to The think, received therapy. as resistance that forthcoming. resistance it cell as antibodies therapy. be cell haven't nowadays as the to really field both that Did to depending we tell. patients BCMA I elucidated to can't the don't antibody is speak cell possible, information may respond And I on being know mechanisms in in of mechanism information there's to BCMA it they we space, antibodies.

Mark Breidenbach

Okay, thank you.

Operator

you. Thank

Newman with from comes John question next Canaccord. Our

line Your now is open.

John Newman

thinking for guys. marrow What the I ALLO-XXX. today, Thanks bone done they wonder, know autologous long donor? allogeneic and allogeneic an just normally an question. the a a Rafael allogeneic a ago, broader do question Or utilize of autologous first I'm long, today. expanded transplant bone and time actually marrow wondering bone Obviously, for bit to they if taking this think, good for XXXX. CAR-T marrow think good about for be versus is My David was this both or to is the then. Hi is, autologous kind BMT transplant hold Thanks. I'm allogeneic greatly of mean, about we corollary donor? back going do I out I wondering has question. might transplant wait allogenic a since way question

David Chang

non-Hodgkin's do to as your Rafael, in the new improve want coming therapy the about you John, the landscape question question. and for previous Yes. in. question. thanks lymphoma take Certainly, the that the question to continue

Rafael? So

Rafael Amado

common. marrow Autologous rare in is is more stem of this bone transplant non-Hodgkin's lot is this assuming in I'm lymphoma. relatively a transplant Yes. Allogeneic context space. cell the

allogeneic of therapy toxic there bearing stem entering think, which bone CAR-T from CAR-T regards and with very it's ever prior are transplant, fact, They therapy, our unless autologous I of Because, elderly it's studies in these autologous therapy from cell the are CAR-T mostly And transplant, the many study. marrow sorry, in to therapy benefits – that benefits So patients. benefits again to done. autologous different into The versus have patients. of in patients I'm are allogeneic of in other haploidentical received disparate. very is studies the hardly different very are that a very allogeneic of the the is general, benefits

So – those. comments I I mean, would I think to limit that's my

John Newman

Okay, Thanks. great.

Operator

you. Thank

with Our next question Guggenheim. comes Michael from Schmidt

is line Your now open.

Michael Schmidt

prior thanks therapies. just your ALPHA patients I comments Hey a for Good taking that on morning my around the CAR-T guys. autologous and had in received questions. follow-up study

maybe I you be to trials use for think even resistant-type that given wondering may there better a was mentioned – development be CAR-Ts may expand products. YESCARTA work and ultimately auto of there how for and responded, ALLO-XXXA you more think additional none might the I sort a as this path other phenotype. you much those CAR-T And understand will how in affect that readout doing of and

David Chang

on ASCO are define of at reporting I a done And One interesting certainly, those the limited early emerging. unique, autologous not patients reporting more ask autologous Yes. very would are failure than response poorly. has have been maintain very a – enrolling in think we setting, thing not to who was were – the asking, we the Rafael what setting. for on tends to I be expand well, in people failed, able that going lot that's study, redosing, who which relapsed and the months. of Michael, that you patients who there findings study in lot, CAR-T the I'm even because something our we yes, our did as as to that seen CAR-T to it In respond one was to to are response two emphasize

So finding to think potentially at and and could, is interesting very those something patients, predictive we are some day, we more involved exceptional we lead medicine. that

to So on expand with a little that, more? Rafael, want that bit do you

Rafael Amado

say defacing in or mechanisms pathway, TXX. issues due presence that and are the receptor the data Marco molecule Yes. itself, of There's with I are from being to about would the – intrinsic the elucidated. resistance mutations TXX Davila there resistance from Moffitt that

cell a That benefited resistance that patients to and of long there to and respond that CAR-T CAR-T to wanted that from autologous. mean we that which therapy may a not didn't. therapy, doesn't And patients so whether for try intrinsic that's therapy, that T are benefit found oral see we have patient time they would from to auto AlloCAR the period out

study. completely that so CAR-T yet that answer or And allogeneic and that haven't up something we a will, T as can we not is they we're to And think, on I subpopulation get therapy, and patients. going therapy there's CAR therefore, autologous see an given relapse to from whether patients these benefit of

Michael Schmidt

Understood.

I to like as kind understand So poor that. it were sounds those in response be the of first place, very preselected patients

Rafael Amado

we patients that wouldn't patients – do the well. – is those because don't think Those further patients experience I treat those Right. would

Michael Schmidt

you. right. All Thank

Operator

you. Thank

Our next question with comes from Securities. JMP Reni Benjamin

now open. is line Your

Reni Benjamin

to the comparability a will the pivotal us manufacturing done, Thanks Can you on it facility. ultimately? remind prior or taking Can progress. and Good in the remind be or that just kind to be be what all questions study first will – My kind bridging guys. online be prior with to for morning know study just congratulations the XXXX. of of you us online do I question has to to facility need capacity needs What of just commercialization?

David Chang

Yes.

about question will cell the kind deals frequently this industry bridging And to with, bridging that we something analytic in is studies. the I facility. therapy limited new study a doing area, study. great bringing mean the that believe bridging of So be

we So to that facility, as clinical we online really facility, and which material. we in is I the always are have mentioned, go the is in come start was that a And plan, state-of-art quality Newark addressing manufacturing as and CGMP going already forward. think XXXX

plan. according proceeding to is everything So

Reni Benjamin

out commercialize could we said facility? we commercial products of multiple And that

David Chang

Absolutely.

Reni Benjamin

Got T-cells as talked about to kind types, give it. just of alpha-beta gamma get a going? I And are thoughts also Got past, how to guys other about thinking focus as T-cells, you well. I on if of is types your but type us a guys a wanted it. including cell you you just in follow-up. the as Can think Notch collaboration sense have delta

David Chang

Yes.

into The I'm primary extremely Notch point responses going also allow the since the mean, has we're proceeding cells are of out the quick technology focus. time. phenotype. is Certainly, can developed about the we But I So keep making running relatively that the collaboration well. to know that that's to differentiation you Notch T-cells, cell lymphocyte other develop the

an to many building we as obviously, And collaboration. open and really expand we'll for that's question. the different So explore continue we're options our the IPFC, future,

And very are going. so pleased how we the is far, collaboration with

Reni Benjamin

question for Thanks the taking guys. Great.

Operator

Thank you.

Blair. William with Prasad Raju from comes question next Our

Your is line open. now

Raju Prasad

guide get and about then for Thanks data redosing in could any see clinical on other the might TurboCAR in would trial might BCMA maybe just plus responders in these the on And any context ALLO-XXX myeloma versus we in in data – results clinical the be just, in broader there redosed in where some that three you for in, that taking enroll Will in having the data question. of context a fit patients soluble how QX? ongoing clarity program. thinking potentially protocol and UNIVERSAL I being these just GSI And of there then myeloma levels patients, context the in the Thanks. XXXX? want you patients? to on multiple get on with some the just UNIVERSAL? multiple trials is And patients

David Chang

Okay.

I think there. that's There's questions Rafael. several

quick. So the Rafael? response real let's keep

Rafael Amado

subsurface, levels something we And of with plan that's there's we it's something are we BCMA in so protocol, do nirogacestat UNIVERSAL multiple with and are myeloma. really of terms that. lot improvement included XXX in in think Redosing going in that's the that study. know I And that, the that the room the cycle preclinically to to about So circulating then and excited and have that And – very innovation will better, ability regards and XXX, for the XXX. to we closely brings. we a to also is results

I innovation think steadily. through answers I So that question. sort moving your hope we're the of

Raju Prasad

Thanks. Yes, that’s helpful.

Operator

Thank you.

Our next question comes with from Truist Asthika Goonewardene Securities.

Your is now open. line

Asthika Goonewardene

for others. have to impact product maybe you you some you morning Do X%? QX? data question. on you. in & And from progression? the of level CAR-Ts we eradication MRD-negative planning disease and of thanks go Johnson got X% good other tumor negative – level data in meaningful maybe think upfront as Can as the about think guys now I was negative from you multiple myeloma, is to to digest need taking you saw from to there well what a the do or we wondering Johnson necessary some that Thank Hi, for talk presenting us to are data on this then ASCO

David Chang

Yes.

quickly. So let that me just take question

basis, molecular And of seems the the – assessing is or the In I question the to will certainly, do the take are following data. mean response as the deeper response mean, to better. X. of level MRD emerging study, the I we tumor way MRD. will of new the part be level using evaluating related terms X we really the MRD they

are I think all In that data that that obtained way from watching we very terms CAR-T the can new really one how in of response, setting. assessment. and the disease the relates think MRD response, be are But mature can it assess to as this nirogacestat's the read is I early to the something duration a excited of we that's durability the

answers your that hope I So question.

Asthika Goonewardene

Yes, thank you.

Operator

comes And question Stifel. with Burnett you. Thank our Ben from next

now open. is line Your

Ben Burnett

Hey, thanks very and much morning.

back a manufacturing. question Just to

the also and the ALPHAX donor terms ALPHAX from in the terms As manufacturing versus ALPHA of in guess led learnings process first of that's modifications study? first there in age, are manufacturing? online, donor start ALPHA study to in to bring any type I And you any anything

David Chang

something will we we trying going done in which silent but donor is Ben, already that a robust, I also very something making try mean, are That's but the the types. relatively great doing of there it's the require to manufacturing all on that are we have question. in characterize points, data stay I we lot interested manufacturing. that learning. more terms to mean, on on things

have So cell also XXX. consistently manufacture not to only been far, the and products for able XXXA for but XXX the we

of terms that sense not capability important. that continue some our just is very we which of in I and continue yield the will cells think [indiscernible], something invest the improve, quality to but also of is So gives in this to but the

Eric Schmidt

initial ASCO presentation, Ben, may the we recall you in also all patients the run. that same treated XX with manufacturing

be in So premature there. call terms able showing queue clinical questions further us to this back the findings, remarks. for for it's I'm like to the of the Thank to closing turn in comment time. at no I'd you. And any to speakers

David Chang

your we AlloCAR us our thank as therapy. T on today to you support Allogene call on the of for for pipeline progress First joining and continue all,

stay healthy. that, and all may you you hope disconnect. And So now well with operator,

Operator

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

Allogene Therapeutics (ALLO) 6 Aug 202020 Q2 Earnings call transcript