ALLO - Earnings call transcript Q4 2018 | Allogene Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning ladies and gentlemen. Thank you for standing by, and welcome to the Allogene Therapeutics Fourth Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please be aware that today’s conference call is being recorded. I would now like to turn the conference over to Christine Cassiano, Chief Communications Officer. Ms. ahead. go please Cassiano,

Christine Cassiano

and operator good you, morning. Thank

This open provide a market fourth at and XX, www.allogene.com. today, our available results Allogene to release quarter XXXX. December ended press a full-year release corporate website the is on issued for Before press update financial and

section trial trial in a We provides slide and be Clinical an ALLO-XXX news replay. that for posted found have under overview Phase our also and We be investors will being on that the can events. which the be call will today’s available X website webcast of remind discussing protocol and our website our on listeners is

Financial Dr. me Chang, Dr. Executive President, Officer. the Chief Chief and today Joining on are David Officer; Schmidt, call Eric

be as XX-Q and forward-looking include certain forward-looking uncertainties capabilities XX, the risks filings those are actual call, the efforts, materially year cause During assumptions, number based that and contained as the statements. and for September December and securities upcoming and well with of on will and XXXX, research are today’s ended made our including change current XXXX. These results differ, Form in quarter regarding commission, information, and to statements financial These risks clinical among that of our described our may in periodic Form we future the development and statements. are may planned XX-K other from our exchange XX, filings, timing for subject and ended involve other statements ongoing success expectations things. the guidance forward-looking manufacturing to XXXX a regulatory These trials, making

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

David Chang

Allogene’s today Thank call. joining you, first you morning on and all Good us Christine. quarterly thank for

our months we have building a Allogene management us questions and ALLO-XXX clinical our was to very very that we We successful for as are the brief From we forward activities. we XX look our what ITO XXXX may will keep of IND stellar you candidate, began and since the at for other our business and scripted acceptance on are any a and just our ALPHA year on to we rapid proud accomplished first team comments to in plan short relatively memorable excellent team making continue and progress, believe trajectory. executive we trial operations.

refer therapies XXX% is bringing Allogene are opportunity achieving we to We AlloCAR them we task T all that goal. patients at appropriate aimed as on treatment. market T focused so to at or to that undertake the allogeneic CAR Every receive have

AlloCAR therapies in successful overcome need hurdles for While believe in we successful. to of be manufacturing difference we We the patients believe that programs, what manufacturing and realized are therapy the team T cancer outcomes In that is know cell to a patients the patients. resources for strength experience, we technologies, technical therapy. can make and products operations with will of many frontier in to order is Allogene and time next development our well-positioned tall the we bringing people, the is pioneer before the or

of to [this one we’ve such, be resources As devoting area]. will this priorities considerable and made time our top and

commercial the manufacturing state-of-the-art new lead the East our therapies. Alison’s our products of suited of advanced Moore. facility being GMP Biology training to Dr. facility the best step supply this to industry Alison regulatory vast cell XXX,XXX in manufacturing first in own well upon Our signed was manufacturing one foot is to in potential are experience challenge with and in biological designed This effort is our Network and AlloCAR people the Allogenic provide fast build underway production for building lease Bay Cell approval. to the to square capabilities. for T clinical hire

year, would ALLO-XXX In lymphoma trial relapsed Now, cleared to this candidates. I NHL. our FDA advancing or progress like with the ALPHA discuss our in we patients made IND refractory of January in non-Hodgkin pipeline

We the the of This ALLO-XXX are submission. a which the and utilize X Phase a pivotal identifying as first anti-CDXX ALLO-XX, in antibody part remain the the monoclonal of lymphodepletion to optimal currently the goal Phase of used setting study potential requirement we Phase trial we for dosing for similar on to process study, X been of criteria in to of Patient the proprietary trial HLA designed qualifying matching. track entry have will autologous and this also clinical ALPHA are ALPHA dose of ALLO-XXX assess is portion levels the this what The at trial there regimen. for safety initiate portion PLA of be trial the and in the could an potential in is dose of no year. sites with increasing tolerability of a X half portion for our

up dose will efficacy be on higher per or Not which the follicular lines call. slide cells, of systemic that more and relapse we after B-cell referenced and demonstrate patients T the in therapy lymphoma starting the found cell at dose to initially with lymphodepletion design. large possible to optimal the million It equates regimen to XxX of patient be ALLO-XXX. dose kilogram. starting roughly cohort maybe two we Christine enrolling Specifically, CAR Details XX is required XXX,XXX in a refractory of XX can and of trial that earlier treat this cells lymphoma

medical optimal ALLO-XXX important durability regimen, we is us complete lymphodepletion understand the better CAR trial ALPHA anticipate of to as identifying the ALLO-XXX of clinical first In nearly the planned, XXXX. lymphoma addition should where XX% demonstrated this a as T the reporting two-year has with ALLO-XXX. data to non-Hodgkin induce meeting the potential of a to in of study also consideration at This potential dose part patients of the autologous in in half initial to from therapy response proceeds an an the remission trial at If follow-on. treated

over I to the would quick UCARTXX also update provide a on like Before to both call I and turn ALLO-XXX. Eric,

support advancing Servier, continue pediatric partner adult the our in UCARTXX We and ALL. to

from supply trials and on X We put with ASH reported continue on CALM studies begin update to pleased last a they PALL the analysis in their Servier, last project at are year. now work Based XXXX. through Phase issues will and our

a BCMA targets this FDA the to on inclined I later which myeloma, X year. study clinical Eric. of patients the and with an refractory over initiate now ALLO-XXX, loss a the will call remain treatment for IND Finally, to to submit we multiple relapsed for pass track to Phase to

Eric Schmidt

quarter we Thank you, and press overview David. release year-end The today financial of results. our provides fourth an issued

We additional which XX-K, details providing filed in will be with the will be SEC. our

and Following our buildout clinical further the financial equity strong and advance mentioned well-capitalized David manufacturing programs offerings development of position our earlier are call. XXXX, to the in we’re a support on

XX, of Allogene and compensation XXXX, million. research As $XXX.X non-cash quarter, cash cash, totaling In $X.X our which were fourth of expense. investments stock-based equivalents and includes million the had $XX.X expenses December million, development

year were The stock-based million $XX.X includes $X.X of and related fourth $XXX.X total non-cash to research XXXX, million the expense. includes non-cash full-year million, for General of Pfizer. quarter $X.X asset million the expense $XXX.X includes compensation for the stock-based from acquisition XXXX, research the million were of administrative which and expenses which expense. compensation development expenses development For and

For the includes stock-based million non-cash expense. XXXX, expenses $XX.X $XX G&A which full-year were of million, compensation

expense stock-based $X.XX Our compensation share, million, fourth $XX.X of quarter $X.X for or net loss including per the of non-cash was million. XXXX

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

now financial Turning guidance to for XXXX.

loss turn share Allogene’s full-year $XX from estimated stock-based our that calculation excludes outstanding XX At to million our net remain million. any would to beginning while XXXX conditions. share of we excluded have exclude million. XXXX, to expense questions. will of to from the With business call now please financials, approximately that those note [outstanding] shares you to vesting calculation that of be number activities. operator, like expect our GAAP million subject GAAP be million over $XXX the between is And $XX that We the million I of loss per and includes per will This those impact compensation potential losses for XXX.X shares an development non-cash $XXX and modeling

Operator

first [Operator Instructions] Salveen question Our comes from Sachs. Goldman Richter with

Salveen Richter

Two ongoing? sites enrollment and of how T just you Thank Good me, given changes taking could with questions. my processes that including sites from just trials this from are secondly CAR versus us number of how in in the morning. to NHL UCARTXX? And is ALLO-XXX Thanks trial, are you competitive for the remind the manufacturing you. these then many

David Chang

both Chang of questions. those Good two morning, questions. – the let and take take for David actually me let Salveen. is me Thanks This those

identical In really ALLO-XXX process. ALLO-XXX, construct terms to know UCARTXX, the manufacturing has what you the we as communicated, nearly of molecular of changed previously have is is

to if I on the the stepwise goes raw assays also general, then whole how products. materials, going take manufacturing you between, entire supply and includes the what So, have and consider. laboratory manufacturing have And manufacturing that the during through that It’s The about, and when this that there assays matter the a the different few taking [indiscernible] sidetrack tests finally reagents into is chain release in are manufacturing just bacteria's, that you into what’s cells any process. all to care you has have lastly, you and the a to and of, for includes a not produced and intermediate doing happens viral that. go that in in things understand many one you there the just process material, then to all cell issue cell can know the aspects manufacturing around

as made consistent, a result that those yield additional each and to previously as based we we we would will manufacturing. big we continue can what and XXX improved we robust is said, on patients area but I currently the So, more up and in volumes is as we really run, this to have production of the have that that manufacturing that each incrementally about manufacturing consider we process end change, have we haven't go to shed and done believe from already estimate introduce improvement up large

So, the a that the involve will X activation. study manner. a site second controlled is of in in Phase question, This patients midst

sales some of per As will and the as we we approximately on million patients X exploration, we XX is do Phase embark the have study. dose as lymphodepletion the optimize trying dose to starting Phase well before said, X the

that between we the sites site expect and interactions investigating the X, so has our will with of positive. range somewhere been We extremely will number need to far, X

any involved involving fine. of be I patients will as will expect today. just in terms because the we with we haven't we therapy once patients, actually little identifying but we and up say patience open bit We study see a of of

Salveen Richter

Thank you, David.

Operator

Our next Amin question Jefferies. from Biren with comes

Biren Amin

for initiate clear me guys. XXX David, questions. my on you need guess taking before Hi, ALLO-XXX, that the Thanks study? to you I do let just IND get start

David Chang

for that short Biren, of XXX the good care is, question. ALLO-XXX The the study of, morning. answer been part will using – long another in Thanks has is, as everything we and be a short answer and taken yes; lymphodepletion. answer

So, or not will for seen very lymphodepletion. learned responses. In seen have we as may we only received patients to as who And is the latest of ALLO-XXX AlloCAR expansion, not is for who response, UCARTXX Flu/Cy anti-CDXX on based consistently much have you own the we than is, cells of require robust or plus had antibody those both cell expansion Flu/Cy T our conventional received what know the set more patients this at but cell it’s as a update Flu/Cy we antibody. expand presented well ASH who small XXXX, the study that anti-CDXX patients, proprietary whereas

Biren Amin

study, as CALM study cyclophosphamide basis. UCARTXX of the Okay. daily to you And are are using, as fludarabine but the the ALL that a there then I and dose the a I is regimen David cyclophosphamide for regimen I I I study that adult using design think a on change, lower for think same using CALM, and lymphodepletion think at compare look you ALPHA the

I think XXX. ALPHA think, used XXX CALM is I verses, using

kilogram the change? that think days? how behind So, XX daily and the to three understand I think for we of using then alemtuzumab I dose per milligrams should CALM are rationale about where used you milligram kind what And X

David Chang

that modifications placing are with minor are the lymphodepletion. [indiscernible] on study you Great details design. introducing our are the There that to we question. Impressed

from dose point, the learned minor antibody alemtuzumab. dose the down introduced Some based changes of of not cyclophosphamide make also bringing adjustments we bringing of the some based we is this notably on these anti-CDXX will the anti-CDXX using antibody. on have have the what own pharmacokinetic we And we to enough modelling. down others proprietary be in ALLO-XXX of at and just believe our in to information and correct, being and the And study, this

sort are these we of doing and learn as we so, lymphodepletion and as is And this kind a sort little be will bit that of X to do to outcomes well really X other of need a these of expansion in cell can adjust explorations our and study. dose certainly as the Phase planned we as is cell to efficacy-related we some Phase optimized what lymphodepletion,

Biren Amin

on then rectify color And X XXXX, you can start what get think the on guess trials I would need question, UCARTXX mentioned just Phase maybe I Okay. now a process manufacturing this last for back what provide and Servier to the track? to you on –

David Chang

manufacturing, and provide is a input well development as partnered into both programs. program. with work I advise – we some Yes, Servier their mean to try it as and closely

the defer kind to of comment, anything things I up earlier and would but a it done really lot is of in different details in be It question do Servier major, to talked things work. manufacturing. Salveen’s to of little to these add to really has that Some one needs not response it to the

you improve time. For those example, an to assay start the and you actually have assay, to can validate things if you before develop take the all do then it, use got assay

into be work move a X. I program right that to think and they XXXX in feel now I confident of Phase UCARTXX lot ongoing is the will able

Biren Amin

you. Thank Great.

Operator

Kasimov JPMorgan. Cory from with comes question next Our

Cory Kasimov

guys. Thanks morning my for good questions. taking Hi,

Just a them. of couple

that. And First, a this manufacturing the to have of Phase of regards at you is more to in kind us just I needs trials with mean, you there for point that update I X/X terms place? can are do you follow-up XXX, produced? manufacturing still enough where or take doses after for product then have

David Chang

Okay.

Cory. So, good morning

I’ve terms point will of to each trade-up upwards said, manufacturing at material of enough we as In batch patients. ALLO-XXX, manufacture XXX this additional produce to continue of upwards batches, but can

terms complete planning to So, we have patients, X but the in definitely, enough other material also of Phase things. do of XX we are study

is production currently ongoing. additional So,

Cory Kasimov

question be with hospital what four utilizing Okay. fusion to expect do post And then my antibody? other regimen you stay patients the typical a is, anti-CDXX cell

David Chang

Great question.

We ALLO-XXX non-hodgkin have patients. lymphoma not studied in

the factors that in, In things patients including hospitalization, terms in. of there the different disease and are is many that conditions

neutropenic pretty which and, dosing reasons require are into can know also, needs sample even the there is our that the patient really Sometimes can one collections come cause be, the trying hospitalization patients we lymphodepletion, to of in frequently. the which outside they Phase hospital result And are in are you to that to optimize chemotherapy X if the lymphodepletion.

have on the what others long terms lymphoma hospitalization So, days need based be we of based X to the could X protocol will hospitalization between anywhere on XX seen determined how the days. X stay our Phase require as part days estimate in and a of And in Phase of exactly the they few will experience. will in be non-Hodgkin's to hospital

Cory Kasimov

information. Appreciate Okay. the you. Thank

Operator

from next comes & question Company. Phil Cowen with Our Nadeau

Phil Nadeau

morning. my Good taking for Thanks questions.

dose trial, the on the dose, that one [indiscernible], said that starting XX six], arrive two levels the that in think your CALM? either the to XX in doses the one that how XX×XX the you are between, First were versus dose do calm tested is or tested the what’s to on six you in XX×XX for rationale to assist so [X×XX somewhat in very dose I Servier the starting study of

Eric Schmidt

the is said, that dose. Phase out experience some come ALLO-XXX to study up – even have X a indication reasonable go trying from were testing tested. of we I’ve dose a efficacy then we with as been UCARTXX the because in chance the progressively And are and in that higher not has coming with So, starting we to this previously an

we Phase optimal where see be during the study. the on what So, the think will we will that Phase dose the Phase for I depend decide X, X X

Phil Nadeau

That per used the CALM using how backed think second, Got said, you makes cell then off given bit, anti-CDXX then XX you more times question doses response days, be a mg of why and And I talk to X can off on you did you the important the to day per in three on compare sense. anti-CDXX little how you those expansion, bit to Biren’s dose milligrams back it seems and kilogram a then dose the a two for dose are bit? decide it. on

David Chang

in trying lot It of the do we information And on X stay has pharmacokinetics well really short of a as based CART as running modelling thing sell different the available be the pharmacokinetic can was considerable T is it X another Phase in you because a the study of those anti-CDXX at I throughout went through to really as done the was proven lymphodepletion, optimize do that the CDXX when completed study time. where program regimen, in that doses. study test lymphodepletion to end we with some which right started modelling. period have we antibody, a about I in mean, the to the study to on experience, Phase able same the we a relatively be preclinical and well early that once the spent to We my to the the study. some explore were previous different, as time allowed

Phil Nadeau

the Okay. And, conversion. curious I on guess, I'm

for versus used in anti-CDXX to XX get they about protocol was kg on an CALM? going half average Are what the So, adult. your

David Chang

let’s half. maybe be, less than see. will slightly That Roughly,

it’s correct. is your estimate about, So,

Phil Nadeau

those mentioned but in any XXXX patients you virtually are the be to would great. question are patients And in enroll able do complete a is now just XXXX, during the in to X helpful. CALM in going That's Phase PALM [indiscernible] expect trials start they now, Servier, Okay, more they then X in trial patients XXXX? the or or follow-up to on last next enroll Phase

Eric Schmidt

Yes. active to in studies Right by of are improvement that patients [pans currently now, how mean being the the board of are I see out]. we in need enrolling additional patients. on sort And terms not enrolling comment the investigated of XXXX, some

Phil Nadeau

it. Got

questions Okay. progress. the on taking and Thanks my for congrats

Eric Schmidt

you. Thank

Operator

Our comes with Mark next Breidenbach question Oppenheimer? from

Mark Breidenbach

thanks good have for of my and answered been morning questions. this at point. them Hi, Most taking

Just lymphodepletion one regimen. on the more

concentrations in to the patients assume able possibility your being You first doses fixed being we the but can lymphodepletion, or are side? alter used for or mentioned the in that reagents the listed of some doses of the of that were modulate XX that

David Chang

Thanks that the now in important part very the of shared design X know for Mark. slide question. has is earnings detailed study, Phase call. Christine that as you right as this

where have know and I few the result, In of give part expansion much adjustment lymphodepletion and what antibody – the I lasting. anti-CDXX to during X know make further mean nature be would that roughly you on lymphodepletion tension is Phase shown coming without and ability ALLO-XXX as deeper people lymphodepletion. seen can as you quickly. the is all study will if is say, is and of And, seemed And the that around of to And call, with don’t make augment changes a of our to the X but the have the able those I really to even be also any People the just they years is really to know, this is more were some you the our cell considering lymphodepletion based an terms get to in. beauty us is the a expansion. we that autologous be therapy. of especially opportunity amazed some and can need our impressed very lymphodepletion repeatedly not protocols. lymphodepletion from we mean, of dismissive also, ago, you there you needed. cell additional dispute to about get assess we sort When Allogenic is Phase that, safety doing that and lymphodepletion will I’m

the So, allow cells length expand of and time. desired persist seems for to that certainly T to AlloCAR

the So, will expect will progress XXXX. the Phase transcript, we of certainly, prepared be as And said we on X study. updating keep you they available in that we in

Mark Breidenbach

only otherwise, might altogether? get preclinical say And there is be lymphodepletion with any exclude you you Cy/Flu would or able away CDXX a evidence suggesting to regimen eventually that and

David Chang

you Well, question. the that are probably, ever question. asked first have great This to one is, I think

Let’s exclude not tuned. and possibility say that I stay would let’s

be looking just some in give study, those will XXX to We ongoing way to the [indiscernible] a in will study us to of not AlloCAR look lymphodepletion our as study, opportunity the T another planned but at XXX many of the studies optimizing elements therapy. planned

Mark Breidenbach

Okay. Thanks question. for taking the

David Chang

you. Thank Alright.

Operator

back now This to concludes comments. over the the turn Q&A like management for any to additional call session. I would

David Chang

we without have next time months now so have Operator, possible. them the would updating XXXX look disconnect. Well, been and all what group with certainly such made I time date a pleased continued and success I’ve your of to short-period we thank milestones, support. you who thank our We're to of would especially amazed over far we as for have advance up you And and small you progress today. make may coming employees all like Allogene. the over and for do about planned thank done been your very the the can you we achieved forward had we people not

Operator

you all the Ladies disconnect and your and conference. have This day. today's gentlemen, thank does in program, wonderful you participation for conclude a may

Allogene Therapeutics (ALLO) 9 Mar 192018 Q4 Earnings call transcript