Cellectis (CLLS) 6 Nov 202020 Q3 Earnings call transcript

Company Profile

Participants

Simon Harnest	Senior Vice President, Corporate Strategy and Finance
André Choulika	Chief Executive Officer
Carrie Brownstein	Chief Medical Officer
Eric Dutang	Chief Financial Officer
Gena Wang	Barclays
Yigal Nochomovitz	Citigroup
Jim Birchenough	Wells Fargo
Kelsey Goodwin	Guggenheim
Salveen Richter	Goldman Sachs
Hartaj Singh	Oppenheimer & Company
Wangzhi Li	Ladenburg Thalmann
Raju Prasad	William Blair
Madhu Kumar	Baird
Kelly Shi	Jefferies

Call transcript

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Operator

Greetings, and welcome to the Cellectis Q3 2020 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Simon Harnest, Senior Vice President, Strategy and Finance.

Simon Harnest

everyone, results third conference welcome, update XXXX and financial and call. you, to quarter Cellectis corporate Thank

our Joining is me Dr. second for on our a are XXXX. Chief Dr. press the XX, Officer; quarter Chief call available today Choulika, Medical press website our evening, The Chief ended with Financial our release Officer. at September Executive Cellectis Eric reporting cellectis.com. the Officer; and Carrie on Yesterday our André Brownstein, release Dutang, prepared issued remarks results financial

we a recent risks financial Commission differ the subject to may makes please As be with can the These product for forward-looking outlook that in subsequent will ended management filed our SEC results these go XX-F the are to André. reminder, make development I the from turn with found in ahead. report, statements call Securities those addition time filings including the over to statements Form and XXXX, André, the uncertainties report actual regarding financial risks Exchange forecasted. to and to most would now December from and Cellectis A regulatory cause to like of plans. XX, time. year and and description

André Choulika

an our today's from Dr. and Brownstein data Officer, Carrie Financial in in upcoming at Thank followed These form these for be as conference. subject update presentations Yesterday, updates Cellectis series financials Dutang. Chief of our thank our a oral you, will abstracts will on as abstracts Officer, for the sub-licensee, you, Medical Good the Chief and joining Simon. main by call clinical our of well morning, selected Eric everyone, the us today. ASH Allogene announced summarize of detail,

trial CAR at upcoming two clinical a readout BALLI-XX data allogeneic in BALLI-XX dose cohorts quick ASH oral of presentation December. has the This for of investigating recovery. data kilogram cyclophosphamide the interim clinical lymphoblastic on interim announced B-cell per early the abstract escalation our overview, standard of and out UCARTXX, patient wholly-controlled in the leukemia first of with fludarabine cells with remission program. been abstract refractory or achieved selected T-cell relapsed This regimen, complete an provides one As first of study of the an dose an dataset CR acute yesterday Cellectis conference on dose without XXX,XXX second or alemtuzumab, the and Already response UCARTXX patients a with lymphodepletion level three best incomplete the CR hematologic two of at with patient

the for in selected announced abstract X in poster relapsed/refractory UCARTXXX patients. trial second for progress Phase AML presentation dose also study We our escalation AMELI-XX of

are cleared two are available. update first progressing forward have to and clinical DLX looking the levels to We and dose when we presenting

clinical T-cell updates give UCARTXXX the our CAR allogeneic UCARTXX Our on milestones study lead AMELI-XX is in regular AML. strategy in program, forward to B-ALL the in study and BALLI-XX moving for in

to knockout T-cells. We cyclophosphamide platform gene to are allogeneic alemtuzumab invention utilizing studies, the the start plus of dose CDXX the to fludarabine of with our gene CAR Cellectis patented for both lymphodepletion cohorts addition regimen, about editing in

UCARTCSX Our is with in the study. in third first dose program, multiple relapsed/refractory wholly-controlled cohort myeloma in patient MELANI-XX its

as as get we the have proposed path is to have to the back We on hold, any soon straightforward candidate study for a on responded the are clinical in and this we plan of this currently will clinical updates waiting on While agreement track promising we questions available. and share an forward. development, FDA believe

ALLO-XXX virtual CAR across data treated candidate ALLO-XXX exclusively with relapsed/refractory an which and dose milligrams ALLO-XXX to multiple are evaluable include will who Allogene. cohorts efficacy of from of myeloma efficacy Allogene ALLO-XXX, higher is ALLO-XXX. licensed higher UNIVERSAL Our cell evaluable abstract ALLO-XXX for of targeting patient well lower allogeneic XX Therapeutics for as product T-cell presentation on Cellectis as at an doses is announced at sub-licensee, approximately XX dose selected and patients doses for trial investigating oral The under yesterday presentation ASH patients. in BCMA,

in the program, We A allogeneic with potential initial word development tumor in target impressed CAR-T of the future the alliance clinical of to for and our CDXX-targeted targeting coming with are targets the on applications are license month three the plan allogeneic the excited This response end our CDXX and this XXXX, this ALLO-XXX, of additional under CAR rate expanding first-in-class agreement. includes the program. approach, quick regarding submit T-cell Pending Allogene in IND and of in solid first by X trial the combination ALPHA of dataset Allogene’s multiple emerge. to by Allogene as new Phase rich initiate ALLO-XXX X to plan its announced data, continues Furthermore, BCMA ALLO-XXXA filed as ALPHAX ALLO-XXX, BCMA XXXX XXXX. the the expecting trials in expansion pivotal franchise in in is of XXXX. end current enrollment with Phase nirogacestat CAR-T with be myeloma the and a well will Turbo

year becoming ahead. Officer, hand please for This into With ASH major Chief on more powerhouse. Medical proprietary aspect to start Although, who cell an virtually I'm the respectively. go personal by our over challenging new year Cellectis details environment Brownstein, are of this this our every created a life, environment. in and call the manufacturing production in Carrie is United States the excited program. on announce in Dr. to track and we gene XXXX, for and XXXX manufacturing XXXX to our year have therapy like professional in-house independent Europe abstracts go for milestone will Carrie, and I'd that, that has to site immediately adapted a to clinical

Carrie Brownstein

detail open-label safety, designed dose BALLI-XX, André. first and to into at anti-leukemia the lymphoblastic the is Phase December. presentation in oral upcoming with patients on the like leukemia, tolerated first in program study which B-cell in I ASH UCARTXX, for our would presented be meeting you, virtual go more activity maximum preliminary Thank an relapsed/refractory escalation will proprietary X to assess which a dose acute

X, to bone five related of at kilo. administered infusions. after XXX,XXX the As One of patients received administered to therapy. were five CDXX received And received were therapy, of X with trial. and a UCARTXX lines enrolled we and one were the which kilo. July cyclophosphamide on prior UCARTXX with prior prior Dose per cells X six developing Three patients standard all lymphodepletion and of lymphodepletion having million including heavily two four at Level baseline blasts Dose pretreated presented per to prior with CAR-T FC. And patients Level fludarabine, lymphodepletion Patients median discontinued hypoxia two of patient the XXXX, ADC patient with All patients administration, to regimen, were and the prior CDXX as patients between cells X patient one marrow XX%. refer high

T-cell are X Dose or by the CRi complete marrow patients previously achieved CR Level best post-UCARTXX the treated anti-leukemia with XX% achieved antibody-drug We patient inotuzumab, a or treated activity note, One encouraged CR significant therapy. in blasts objective count on Notably, previously the X CAR remission XX two to bone recovery a a Level the conjugate this from two at CDXX-targeted response, with one or one response had CRi. CXX. unsuccessfully minus Dose initial Of patients Dose X XX% day and at observed; with three at was incomplete an in or of day targeting unsuccessfully the patient with infusion. an second Level with with reduction been patient

CAR-T. nor tolerated cytokine patients UCARTXX as of We well are lower a allogeneic treatment-related for allogeneic who nor With dose promising achieved safety syndrome. Grade versus we goal cell These patients validating have dose-limiting toxicities, associated incorporation was and disease, achieved CDXX new is the could believe effector milestone, at no alemtuzumab. no CDXX-targeted show, neurotoxicity and CAR demonstrated prior T-cell two the failed generally X an host to as higher standard or of potential excited FC activity there's CAR prior this we this or CDXX deaths, about levels data immune this with our we patient were target. first lymphodepletion release in developed profile unexpected graft T-cell including toxicities, results time the syndrome therapy, previously

area quarter, cell most years, vast and form a blast our ongoing in population. Phase to trial is program standard AMELI-XX trials approved with enrollment ASH broad a myeloid observation and and a medical in enrollment be meeting. regimen be with for is acute during past and the received significant give are trial of dose X limiting annual simultaneous myeloid in Coming depletion at followed levels in a our receive product patient CAR toxicity to patients this the that I four UCARTXXX, is level review designed evaluated next dose and is are Enrollment AML of in refractory to most position. proceeding. as level hand are products cohorts to dose had an our remains of acute UCARTXXX. achieve expressed will day patients of deeper limiting may the and administration in to that, dose number UCARTXX. a prognosis is to FC safety, segments. the are escalation for year. are alemtuzumab cohorts when trial myeloid without two candidate share cohorts the of explored the common after excited Patients target initial like presenting period, acute presence potentially is and we tolerability the we of administration therapeutic leukemia, activity As the XX X. Eric one ongoing Eric, new year leukemia. to Patient XX. fludarabine, further adults will with with poster, fludarabine lymphodepletion forward on plus cyclophosphamide the available. multicenter started. where lymphodepletion update dose patients next these is anti-leukemia Dutang, preliminary updates dose potential we allogeneic levels and lymphodepletion addition evaluate it dose to and patient can needs, initiated Dose applied In the proprietary our one and T-cell next and financial treatment a AML relapsed With clinical AMELI-XX cyclophosphamide ahead. has of UCARTXXX poor. Novel an escalation format is have these cohorts on in program day on sustained please response the in step, of alemtuzumab more surface the despite relapsed few being leukemia. refractory the the urgently needed CDXXX the would acute now to are by on cleared persistence leukemia for alemtuzumab, to promote evaluating updates majority added presented And looking toxicities next UCARTXXX FC safety unmet our cohorts In approaches of lymphodepletion a of who in a call at and evaluated third and over CFO, already of expansion this UCARTXXX, the go to T-cell progress after

Eric Dutang

including other Calyxt and gains XXXX million, XXXX by and $X in excluding financing XX, using and in months Cellectis nine $XX as The between Cellectis were restricted was of in income million from revenues and consolidated expected an other to Thank $X.XX significant and loss of net consolidated $X.XX million syndicate, offset December driven financing $XX XXXX. $XXX in in received of cash, The $XX cash financial operating from partially fund cash loan primarily cash operation $XX months million offset flows attributable is increase was XX, December and adjusted shareholders share R&D nine operating, These on The million. activities. to a current XXXX, result compared of financial in cash by million third first cash XXXX, This was robust at Cellectis $XX to non-cash equivalent, which was was million of expenses in the XXXX, XXXX. million Calyxt XXXX. debt expenses received guaranteed the attributable of per million XXXX you, to capital including Cellectis months $XXX XXXX. flows into $XX of be excluding the bank Cellectis, nine XXXX, to to financials. proceeds which consolidated of current to million position cash, Cellectis $XX $XX cash of net million assets expenditure net first million assets XXXX, net as first per restricted increase in to million XXXX. lease per months of shareholders attributable net reflects million The or first million in were compensation in that cash $XX share Carrie. $XX financial September million $XX and of at compared standard That of driven Calyxt compared or of compared $XXX next per as of $XX Servier of $X.XX or loss stock-based of September million first share the a a $XX was XX, sufficient quarter in excluding Calyxt or to The share at and by as XXXX. equivalents, position Cellectis XXXX. quarter The used $XX in XX, of increase was of decrease loss Calyxt million loss the and $X.XX $XXX over the XXXX nine to shareholders of by million position compared investing Cellectis net of the was activities

We XXXX, Raleigh our and production deep in would at Paris state-of-the-art to facilities With hand with the XXXX. call are developing laser-focused our André. in to our in entering in over manufacturing of like and candidates to I the that, wholly-owned pipeline into clinic back cash in spend product

André Choulika

Thank you, in CAR eight its have journey nine over more months. our the last Even of allogeneic been survey. the years, pioneering space progress Allogene Eric. proud has we the past T-cell Cellectis the I'm with sublicensee, over made

medical different With knockout beta presented in create to clinical step granted team covering is T-cells CDXX, next persistence well partner company T-cells allogeneic the BCMA bring XXXX. editing that XXXX math using Europe first MegaTAL innovation this XXXX. that we antibody Along in a been CAR year, results property of and of in zinc-finger following targets, and Furthermore, in the early CAR T-cells. as CAR back has gene including UCARTXX, in the XXXX since our was edge these results as intellectual to clinical administration space strong cutting of illustration CRISPR. more to our edited CAR the gene use the the saving opposition in technologies, and the ever XXXXs this the create T-cell CRISPR, patients with an of unmet in on TALEN, early activity, of clinic in beginning. granted concurrent T-cell CDXX U.S. delivered editing as the have with targets needs. allogeneic ALLO first X-microglobulin XXXX. in in of prolong the to in therapy the innovation was the to invention the knockout removal the in way, as our an the constantly T-cell first led to allogeneic the suppress it anti-CDXX and to published life company three just entered proprietary other patent, had Cellectis are is T-cell. gene of In pattern nucleases, targets, CAR to We Cellectis and meganucleases, the world Cellectis already the come One essential CRISPR in upheld five with CDXX, an with such R&D our field drove first the program gene in had editing the in procedure we CAR window XXXX, Furthermore, March, patent applications has TCR T-cells different

T-cells, CRISPR technology knockout together the tend one January, allogeneic arsenal program, program. beta using been success development targeting the essential we in have full TCR CDXX with as and our are make on antigen. a X-microglobulin We covering drive of patent granted XXXX, knockout the such CAR for to alpha of a elements the use T-cell these to successful CAR tools our All of

believe milestone revenue. a to the partner assumption And lead runway our in milestone We success likelihood our clinical its through our of position from we progress expected the projection strong increases program. have of XXXX. milestone cash is our up cash sublicensee of of series program regarding conservative expected This into revenue

from transformation and well our As targeted as in the further our intellectual capacity, therapy each and and licensed strongly over well lead with to a that, believe CDXX percent to up receive Servier with and our to to for creation to With from to million We and of $XXX the call hand $XXX XX of life undisclosed payments up engineering under worldwide I in-house sales. low partner reminder, as milestone single-digit our million the the the value we clinical position could proprietary like the potentially open programs as and directly CDXX, months. Biotherapeutics high targets milestone the royalty in will BCMA Iovance Allogene, double-digit and combination strong would as come genetic next along with of the partnership including operator Operator? or to over property additional Q&A. manufacturing Cellectis the major our cell to the alliance

Operator

Thank today you, time, Our of question-and-answer Please session. question. Gena is we'll be your At Barclays. first a question from Instructions] with [Operator conducting sir. this Wang proceed

Gena Wang

for you have the few UCARTXX. a I taking Thank questions. my regarding

wondering, presentation, clear reason patients, the not it why terms dose pretty high for but I to durability CR we question just the of level how small see wondering level will rate. more rate? the at the see and response So good? patient, level And very adding a full that achieve dose was alemtuzumab? X related because level very is many the what we is Is one, from ASH number the seems And Just dose CR two one in dose understand dose didn't a two, presentation.

Simon Harnest

very Carrie, answer on for to give early. all you Thank it very taking alemtuzumab very, call I'd it that’s a and first our like you time you, can cetera question delegate of the the thank question et first We're to on to who from doses. being proprietary be The to the today. questions updates first Gena, our good program, although best excited very and

Carrie Brownstein

Hi, thanks much Gena, so Yes. question. for the

from this think You're early incorporation of We're to would and absolutely mean, one was the dose I these dose dose and response it see enroll, to to level again, are without level interesting very response forward I a really that dose dose saw therefore these and an to cohorts to alemtuzumab. other you right, with that say again, in the whether more given we with takes see dose the that, at levels. ensure well continuing two, Allogene we Servier is low levels, decided it's looking important necessarily seen part the And as hard we see time levels, chance as We've for partners, data alemtuzumab well our the particularly think we're new to we've as alemtuzumab ALLO as success. think puzzle and of from that us. where giving and higher important, best B-cell given patients the the and that’s NHL,

Gena Wang

patients how And Okay. expect many should ASH? more at the we

Carrie Brownstein

we not mean, going disclose ASH, is to the abstract Yes, because the yet. I the that's we're – what only be is out been until at can't thing ASH data

where is. see we'll that So

Gena Wang

And the fair. last ALLO partner regarding question was my That's Okay. Allogene, BCMA allo-CAR-T.

like infection, bit they would seems a have wondering, we than Grade Just infection. see far one and more little the safety CDXX there, worse data so from X like allo-CAR-T,

these safety different the be why there, between thoughts two any programs, profile Just so could

Carrie Brownstein

which saying sorry, and I'm programs between one? Allogene two you're which

Gena Wang

CAR-T The Allogene’s Allogene’s program. CAR-T versus CDXX BCMA

Carrie Brownstein

that to people think two ask better don't there and indications. very would I to I their they I want but are programs to are say different mean, I Yes. speak that,

but it's So would I, I hard answer, know given would think it’s compare, better programs. than how it's their to I they

Gena Wang

Thank great. you. Okay,

Operator

question. with question Please next is Yigal proceed Nochomovitz Citigroup. [Operator of from Instructions] Our your

Yigal Nochomovitz

Hi, question. much great. Thank very taking the you for

to from had we with bone reduction BALLI-XX patient? reduction the the this time that is just in show this level XX% CR wondering, patient marrow on patient for more is there best I'm can opportunity the XXX at blast the trial, XX%. study? expect that a from those response CRi an that bone still blast to For two marrow or Or

Carrie Brownstein

Thank you question. Yigal, good that's a very

a NHL which it's it's and So and would not sit other patients just like need to and things a leukemia, proliferative leukemia, therapy. you much and that, is rescanned more and lymphoma on I mean, what wait given progressive because and they get it’s where in disease, do to can move

that continue of we plan, the is patient this additional looking a move that's doses kind – and something a that had good like would because some getting to going think that. and make we're the patient had some patient forward response where have activity, And together. And data I as look development therefore, been to we're sense. for clearly had something in at forward would the to

Yigal Nochomovitz

Okay, this And remained whether patient the at ABC, patient? CDXX a after prior then to for for the could failed enrollment? UCARTXX with the CDXX prior CRi with this for expectations CRi, patients that had was about particular seeing failing And at your just that CDXX talk patient positive target great. targeted the bit therapies you success expectation targeting in what

Carrie Brownstein

Yes.

So significant order require in a this to have part of the get to enrolled do patients the CDXX trial, in expression.

there think again? it's a the wasn't didn't part that like I able CDXX, in question the CDXX, some well having the second patients, do feel out So were that was though was… I having terms encouraging that and after we that show activity. so of promising of to issue prior What very for previous work an

Yigal Nochomovitz

for UCARTXX wondering success prior CDXX with patients therapies? your Just targeted expectations in were have what that failed

Carrie Brownstein

the that think chance they're of I a activity. there as one that CDXX, we Yes. is expect mean I good expressing

Yigal Nochomovitz

Okay. just… then And

André Choulika

in autologous off needs the the T-cells of engagers same the thing the T-cell have fit Yigal, the to one that is the of CAR T-cell due are the product. are sometimes engager some It's at injection. the thing I'd autologous patient T-cell failure patient like like often time very it's therefore with that And to of the T-cell super like fact like say to fit. not respond

when inject and don't would doesn't fail, differently, the that it not allogeneic same they respond that when have T-cells you So see... why can mean that's fitness we

Yigal Nochomovitz

Is dose those exploring testing the some levels, AMELI-XX, one you're BALLI-XXX reason just technical Okay. there Thank particular you're Is why there whereas that? three levels? question. four reason trial in And for any an you.

Simon Harnest

reason are three we dose one dose levels. that on The Yes, study, that's question. between and the so is – good a there third there four based into built in the why to UCARTXXX the program, the speak but that's though, actually were doses, is dose we split is escalation second of

Yigal Nochomovitz

it. Got

Okay. Simon. Thanks,

Operator

from with Fargo. question of question. Please Jim is Birchenough proceed your Wells next The

Jim Birchenough

Yes. Hi guys. data that Congrats of guess have of Antigen the function expression? following the overall, CAR? And Will on on just I durability persistence and the of in response, we expect data. And gaps CAR theme on ASH. what of might you persistence, I've of follow-up. just durability terms do you of then think a up got it's more response or initial

Simon Harnest

for Carrie. question Good

Carrie Brownstein

part have Yes. is we're question. well, the it's to bit And looking the going I that's the data so answer to I'm little that are cohorts. we're That really when a data. to Thanks, we not think with to collecting a now questions additional that to of to going said, today. speak are lot and And I think terms with of that data, forward alemtuzumab present – what showing terms we hold the Jim of in going it, in for asking you're that one where

Simon Harnest

so to maybe I for much can and Jim, Carrie, question. thank the And add you

– of enrollment XXX, and Just AMELI clarify, for the are with middle BALLI And for starting the we're without we now enrollment alemtuzumab the addition. addition. to with in and alemtuzumab UCARTXX

right because the probably usage driven alemtuzumab. And very be data alemtuzumab announcing one real alemtuzumab. that's now of for with in completed the to to next are a cohorts, And have the with show we For XX we're program, durability be in then why the over probably quitting XX program, the for program, the Allogene, are is we cohort us similar one addition will the lymphodepletion update number And difference – by of response. and big and ALLO-XXX, patients UCARTXXX without to limited. that it's where with the waiting will the to that two that's this

Jim Birchenough

And maybe just…

André Choulika

ahead. Go

Okay.

is for cell out cells without data, to on to like kept time the for XX compare thing DLX data for three case, mind one to which that adult, is per you here, dose has example like without example knockout, which these et the This example, you level you the have of go, for it's types compare, XX is responses for of when of and a where total preconditioning, type in micro Like when with assess you kg different response quite XXX,XXX patients different this of per other condition, set. cetera. without is the an distract interesting the prologue, alemtuzumab, like CRs. So approximately, for with million no is data two kind anything, in test example, be for – the of of to – type cells

– why why cohorts. made that's cohorts or this or it I with to with think it's through also analyze without that's without interesting So angle and we've alemtuzumab

Jim Birchenough

Yes.

clinic, BXM follow-on sort does when would you Just into TCR the maybe that knockout, knocked just a When IP. a both BXM? of follow-up on the beta X-microglobulin effort, the move and and congrats hitting the on –

André Choulika

I'm data sure this. Well, convinced today the not fully like we've seen with with that I'm

with tumor with strategy combo for we're But of this. repeat and flexibility alemtuzumab be between the knockout BXM in strategy in that think example them going a might really interesting for I setting. like solid for the might be T HLA-E definitely the and blocking is replace way NK interesting dosing way more now the and –

are XX more has the than would tumor it's space, of now So is been something solid envisaging. like something probably we entering are for after and the the come we company which in years papers this that

Jim Birchenough

the of – be the that what any back when finally might maybe communicate just time you street? to CSX, sense on timeline might hear from – And FDA to how and

André Choulika

this want answer you to Carrie, one? do

Carrie Brownstein

Sure.

to point communicate, can. to how So we reopened. forward want about can FDA straightforward second very I with it mean have you we've a the And at we hopefully submitted have part answer Simon path everything this but

on plate a FDA's right I lot think the the now.

back. just we once we're to We're And on more that. and have a forward, that's share hear final. waiting to path So happy information we're reopening how

Simon Harnest

I to And that. add can maybe

as seen and we've the very enrollments an beginning we of So and year patient of this is product start excellent excited are is a by as trial early weeks from there ago the the CSX pretty product patients this and the and in straightforward And lot FDA need us a BCMA answered in have fantastic were this a the we that this plan that think this will We target. exciting to think a FDA we've for to track. submitted get product hear will a very Carrie to we already back. we the we waiting we back said, and as we're everything hear we be of obviously the alternative and the back, street think let is on for clear known acceptable soon as does way to just and questions

Jim Birchenough

Great. the Thanks questions guys. for taking

Simon Harnest

Thanks, Jim.

Carrie Brownstein

Thank you, Jim.

Operator

question is of from Michael Guggenheim. next your question. Please with The Schmidt proceed

Kelsey Goodwin

Hey, ASH? so, then patients us as for we bar kind this bigger to if just I get that for is guess taking question. off efficacy UCARTXX, just picture, look Thank what And at say assess programs? this guess retreatment? you of would initial thinking our I Thanks dosing repeat pursuing your would did be you. you And maybe you Kelsey could about start maybe you're for guide what maybe help with Michael. is on the to

Simon Harnest

sorry. Carrie, Yes. a question for Thanks, Kelsey. That's good

Carrie Brownstein

can hi. Simon. it. problem. Yes, Thanks, I take No

efficacy part the about bar. first So, of the sorry, the I'm so question

is So at, love in of particular, regulatory we and CDXX what a our on it strategy. gives shots us target for why we're looking multiple that goal

a patients very would directed who A, for be an market. so it'd have already can the to bar in or otherwise. be it'd that fast treatment, failed be forward going CDXX whether foresee of options, any whether CAR-T the Lower And a approval you

the very bar so high. at refractory And populations in patient terribly prior approvals not looking relapse All for is

with in single-arm the durable has MRD negativity XX% range. that rates to are FDA So trials, on for reasonably President CR XX% approving

So a upside that be if we where were in to that's we paradigm this in would Obviously would the so could – that up the be looking. is not group, treatment get it activity for than move patients. earlier program better easily that,

we can have like into as one the redosing. when treat pursuing be it where be chemo another of get over in they of then improvements And that how which far in get patients, is auto induction before, I are get potentially important allo-CAR-Ts in one of fact slug we the then them pharmaceutical this remission high in program. are more these So typically you that's try they can know be and to dosed And would an patients and the with therapy redosing, in treatment, therapy normal a In we and that factors mean to as for that treated once. than the remission. actively said All we of type product particular, we consolidate think dose

our with that we treatment a can products. similar use could envision we So strategy to that

in kind we're things So that's as at development. of that be we move going the to forward looking the

Kelsey Goodwin

great. Okay, Thank you so much.

Operator

is question proceed Salveen Sachs. Richter Goldman next question. The with Please from your of

Salveen Richter

other trial as And Good provide leverage? other curious you seeing next. the and just CAR-T design we're that of I'm layout really like the if at refractory down so it's you have right any alemtuzumab I'm adopting and the what to optimize purchase, addition the here, to adding or and in moving landscape before CAR-T. aspect with look just data you you Precision, curious to morning. their or thesis You're are your multi-doses knock allogeneic just with to date? one And the whether takeaways CRISPR into kind Allogene, playing players or BXM playing on from can How from knockout

Simon Harnest

for the appreciate it's question. Thank it. you Simon. Hey, Really Salveen,

landscape the the We with see were with first So we you approach can that Keystone the knockout. in the together very us the at use the actually in file and Cellectis Conference that's publications, to these that owns the space approaches. of gene it's first concurrent the presented We're and to come We CDXX these because the approaches. first alemtuzumab the this the see alemtuzumab. were honestly first as the BXM patents XXXX. rewarding to on We in with editing all patent you were of knockout the the spring administration

a So interesting in their we lot people that echoing are now programs. what it's and implementing that of pioneered

first very can persistence, allogeneic or with in with shelf knockout, giving great but partner the most what without advanced off CDXX way there, sure. in bring window BCMA. BCMA that alternatives an it's very BXM advanced crowded CAR to the our and on CAR, view, have our forward CDXX to if a the targets dose are actually interesting So Allogene a just in that's best have And trying you And have as point pipeline the alternative as any with of the first We shelf. the have dialing of think is to the partner modality think to far for that actually knockout these ones. the alemtuzumab, BCMA different levels, well the as proprietary we're modality are we with show which the and most is alemtuzumab. you from cells of because that we off targets And from strategy you you like space CDXX we

we we trial, the we those are data cohort, in have with we've completed over more will cohorts having it's learned our clinic not the give from show clinical completed the too while all optimizing lymphodepletion yet. last details forward-looking many and what and full five done years think we because important For to make statements, the then

So UCARTXX with very help XXX. lymphodeplete CSX their a action, we're of early own, approaches which we the XXX,XXX XX targeting different T-cell pretty but show alemtuzumab have with before. and to that kilogram, of the targeting CDXX trials setting, in is CAR-T patients comparable per patients CAR already CDXX are well the a that actually CSX we're cells the because knockout of at responses excited ongoing in the in treated for is with example seeing been is T-cells without these mechanism on interesting and CSX as the in alemtuzumab lowest dose and responses which

data showing it, we go of this ahead. was Carrie, kind with add proofs very we set concepts to that's answer two confirm long that already, sorry, a wanted being early. of although So if to please anything, have that But want and you but

Carrie Brownstein

had got there, Simon. And I something think you I say. you. No, it Thank to all Andre think

André Choulika

thank a position for a autologous, cetera. first are it. one the is CAR-T in or of appreciate Salveen. have example, real think Like to be Yes. questions, see I patients an going for really be particularly much two T-cells, as the assets, allogeneic reasons, interest we that our CDXX bringing of of our excluded like an of Like partners, the therapy to important Like quite very our assets poor of of – you these quality important simple. of the series the hands compare, the target a that the as is great very I you thing – of the the is because BLA CAR-T. in lot number for sometimes allogeneic file et you part there within to lack allogeneic When are a company

have protect a CAR-T have also induce competitors index. XX the has induced the of – a CDXX their that hands to and or toxicity – on not to of toxicity proof access the shows IP of for. strong approvable. of the that it's these our easy another behind So, the this our better market data you during that something expansion induced we prove product sure partner, the commercialized BCMA you commercialization on on or When you CDXX can different that why going have CAR, better. you this, that and that for assets that With BCMA then Legend alternative it for come shows be makes and it comes the their by BCMA XX superiority type is CAR, of example with look very from within and when that step at the data that's I'm And much the IP allogeneic

If the trials safe you all into and the IP that for during, go harbor, safe is have you disappears harbor comes out called full-fledged. protection clinical once this commercialization, then example, the a

product quality without CSX angle such produce, time BXM coming a path a we Now, a any And unencumbered to or with months. BCMA, finally, is XXX,XXX less it at see to where which cetera. XXX. where IP targets the of behind targets et side, and registration to XX that's and the has strong others on path our as give results better we than two company that cell very knockout alternatives also even an X the clear that we company the have the clear to overloaded these have kind and in you is a XX, of precautioning heading kg even per the

Salveen Richter

you. Thank

Operator

The Oppenheimer Singh your next question. from with Please proceed question of & Company. is Hartaj

Hartaj Singh

Thank Great. nice Really all. you. update

you how Just boost of XXX, would additional us your much as efficacy you that? and mean, thinking a is give of a a sort One regimen and can with get color from that? some just understand, with also, partner addition from to questions. couple If experience of be I able modeling could your safety alemtuzumab the lymphodepleting offset of and what to there. are any about how to trying XX programs you

your the that and manufacturing, are on clinical doing. competitors I is Secondly, something you're commercial actually way integrating manufacturing, here think

for partners have some what receive XX disclosed that could possible there that the as the milestones you specific actually if as So Thank you. just detail move could update months? help you then milestones to will late your and XX stage. give on us an your mid lastly, are of over much you us based and you And and to into programs could the next

Simon Harnest

much. part. I you Thank second for clinical and so Carrie part first it And question over the then can I'll Hartaj. to hand take the Hey, the of

is our this milestones, becoming relevant making lot are of progress our because partners for of terms collaborative in in So us a very targets.

alliance, then the an and XXXA, and milestone bundled alliance. first in apply if just up in basically CDXX receive the milestone and Servier are reminder, the know rights, payments, CARs, And alliance. CDXX cetera. any and double-digit Servier that CDXX outstanding as would – million this further et is U.S. royalty to between it's one $XXX and are into in low sales. all plus UCARTXX a So, for the we alliance, obviously on are And Cellectis Allogene, whichever to And U.S. those tied ALLO-XXX, rights so it of worldwide alliance, for the well. sub-license just indication, that's to for framework. makes payments as market these a to product whichever entitled That to European

For Allogene. targets, targets that XX are the other there directly to are licensed

target a any alliance. per $XXX plus up royalty million of Cellectis to on in and worldwide receive license to plus on sales out entitled single-digit product up low development of this commercial essentially, So is is milestones, – targets pipeline high Cellectis and a Allogene’s

the sorry in disclosed. already clinical cetera, part has are those question. of Carrie, what targets So that BCMA, Allogene et to And

Carrie Brownstein

time – much should alemtuzumab not key here, so quantify see, that, prolonged for allow key deeper our there's the have And per efficacy expand. think trial too to that can't correlates the then lymphodepletion, in which to more really and therefore translates more se the cells say yes, question, additional how that more but more how is the mean, to I to into is – I to – Back much benefit we want efficacy how we or and the prolonged expansion. is see, only improved that the and should would don't patients. of And alemtuzumab the I much point I these

you like forward looking looks data that to we’re like. what So seeing

Hartaj Singh

to early as to from how move Just the updates that any the and then commercial manufacturing, – Thank XX XX, late and months? you help the and your just on stage with the trials in you. clinical could next from mid

Simon Harnest

the question? want do you to manufacturing André, take

André Choulika

manufacturing is track. Actually, the currently hi, on Yes, Hartaj.

construction be that's three site also but start and the on producing We the on production supplies, pivotal all track products we're think with have we for for the finished, currently supply started MolMed like clinical also the all the and we the materials. with produced Raleigh And year to on And producing we'll raw CMOs So site. version the construction have Paris for backups themselves. next the on, is track commercial Lonza. for the probably

of production company experience in the a tremendous think amount field CAR-Ts. the has I of of

technology like And editing proportion quality why that the the the producing to end the probably technologies the that's think and more we also patient we interesting and because it doses fit at in of low I you end. we're of and results gene the master. cells the gives at produce, product of itself expand quality the get product

where going we is company inside this. So the from the manufacture fully to a think on key the I year supplies. I And is in-house decision supplies think to think is next up the by that ability this What is mastered on company was And move to clinical have to on. step that commercial and view I big of get of organize track good kickoff hope all that we – the standard if like I the the we our the situation we'll the are where of facility. batches be from high And to year production be at right and we now. the company, a are Raleigh out visits first – at able Raleigh the with see where

Hartaj Singh

Great. you, Thank Thank you, André. everyone.

Simon Harnest

you. Thank Sure.

Operator

your with Li is Wangzhi The Thalmann. proceed of question. from next question Please Ladenburg

Wangzhi Li

basically thanks have Hi, the your question. for a taking my dose response, UCARTXX trial, no when is there but and three the have you one expression I alemtuzumab no UCARTXX of not ASH patients, in responses. between noticed difference abstract, much and out current two CAR you T-cell CRi

UCARTXX potential manufacturer, see think already of manufacturing, for alemtuzumab further later expression Do or related I enable the that improvement want any efficacy without be the the on difference? think or improvements color color may the this, but initial more the UCARTXX – difference. you mention to may in and to the you I even have on may if manufacturer reason protein that any over some that

Simon Harnest

the question. much for you Really Hey, that appreciate dialing in. Wangzhi, Thank so you it’s Simon.

of on these What in of we persistence for these big much So early about manufacturing make. don't obviously, it's too of We three. too made our tell we improvements just competitive to terms little alemtuzumab And lot and, certainly for patient but that can exactly the to the a little addition a fit continuously and is purposes, know, elaborate have set the quietly we deal for the cells But trials. at we increases certainly improve something cells and Carrie CARs. it know-how have best up a think always this selecting a do more to of we the window manufacturing. our

are early we're excited while it is for these these that the because treated trials right this therapies. that we a that in also in CAR. and durability been And patient So CRs, That's was the DLX have in super significant we're was something why basically of think response. We're our on have extremely CDXX now. patient therefore, about patients other to also treat, important and to that adding reduction all difficult failed about with previously blast a the they very is, excited

And But alemtuzumab already show the powerful so it talk a only we do doses, bit patients. about maybe with these low we at product have little going be option for vision forward. that Carrie, may a very our and

Carrie Brownstein

sure. Yes, Thanks.

pointed obviously draw Simon So, we able And a again, in yes, That that very dose and difference. out to conclusions. to response. weren't to there's incredibly cohort, some only that this without speak clearly point, alemtuzumab any can't five the with to hard we're patients treating it's encouraged I question see said, at that as why

that we very them we're And thing only think in that we should see, for time room for when cell in it their significantly we the patients. give more because that. to it improve add about responses will expansion expand and So the at excited alemtuzumab, the do

So alemtuzumab. and seen it can't gathering we're wasn't I presenting in in looking forward that, the to early enroll those those continuing to without cohorts future. and that data necessarily why, cohorts speak on But that in to CDXX

André Choulika

around. and add difficult how old process development. elaborate the Wangzhi, you? over and not. like is Hi, like of to becoming maybe evolved That to trade It's secret thing so has will the this of every a the course manufacturing are on companies one version like process time real I among we is would Like

or it to with seriously, at of and with data, like I do such didn't I – CDXX use like responses think Precision see alemtuzumab, example, surprised was have you I other our they that preconditioning expansion work companies However, CAR-T. for BioSciences alemtuzumab, it's don't think look without as like that data because their also that interesting when

right this, flat to et is not around the T-cell is on sauce per cells, that that gene the the great the the and the the vial but everything of there or expansion this to like on with right get you of that dose important, to type the and kg cetera, general, of What low you also cells with ability pieces inside injected that all that there. – like is to the get the inject, why in there amount and gives super the memory, is secret the that cells CDX, way don't you expand the the the do you And quality but can of and a even that's end, powerfully, like only Because – all vial deplete secret the the this CDX, like hint need early cetera, should give expansion, et you central cell of important give also cell, very number DNA why proportion share way T-cell be technology I think and to the end, not the technology culture a memory at that editing fit doses. in product see sauce product the the come the you a you is gamma-delta, response that? is will at the the in have the is to So type extraordinary. are there

Wangzhi Li

or the helpful. that’s the if potential ask the personalize question it, the the I fixed may patient for maybe Got feasibility dose do but last or alemtuzumab tumor see baseline – on the you think play based couldn't immunity Maybe any optimization, dose to biomarkers? is, you or other do protein predictive conditions it a

Carrie Brownstein

Yes. I that. can to speak

think at going that really and point is be we're good looking it. a it I something that's to

doing they we're when the look at the way as dose at the the treatment. lymphodepletion and is plus regulators obviously regimen, a look complication the development think it, I as the

do what because have the is patients will place there though. more for a not I you're but to, becomes saying a of some what bit tolerate bone So the contributing where be a really for as partially for and more that that little would alemtuzumab let's we see it patient-to-patient. who from as much other to challenging there things regimen doses, study-to-study have do entire think high only could marrows they the up you that And we well say cyclophosphamide can. or banged and differences have from can't patients to versus be

explored, dose needs the move that the be for agency, at into us dosing, and just for plan because that's way again, not needs But have as the to be the So some straightforward in a something regulators that as it be standard, a sort as is field, moved, whole of is not of paradigm, forward. cells, that's is my we just and standard the to as I but but opinion. to think a the looked look regimen, something that do it treatment just

Wangzhi Li

lot. a Thanks it. Got

Operator

The next question. William question is your with from Please of Raju Blair. Prasad proceed

Raju Prasad

question. Hey, thanks for taking the

the the the press differences puzzles, alemtuzumab And there? manufacturing Allo to clarifying of how in CDXX with that says the questions, couple time? just to a taking dose in alluded Can being now. – a one, potentially, Just you little over product. you of X Allogene’s regards that color right made of it just that’s UCARTXX and maybe level release it bit versus level will describe dose enrolled cohort describe then, change maybe, with says seemed over the more it Can dose that there's some UCARTXX, manufacturing a – the in

Simon Harnest

that. you clarify it's so for important much question. And Hey, Raju, the to thank very

the partners. part, been since XXXX by On or CARs manufacturing manufactured CDXX our so the UCARTXX have

think, their work Allogene. that over the Pfizer Allogene First, it but it, efforts. and about seems because that seems it now, I it to handed manufacturing don't doing And U.S., like, Allogene fantastic the and details I was and is consolidating all Servier are know Servier Pfizer here in

another so of in of proudly the can we manufacturing T-cells often per saying sometimes think but to cells So that information, one was see. have what don't on say yields I but not some that great that's is manufacturing best we get manufacturing, we I public talk potent of most share detail, don't the really This about the space. the But highest in is question with we CAR ones. we earlier this

what can one XXX So out treat of well patients we manufacturing again, said we run. technically previously, over

XXX% our already fidelity basically gene of is your very XX% scale a cell at cells, yield, is our electroporation This knockouts this high systems not GMP close in XX% And commercial giving lab. have over This in efficient. to is are in scale. We are to manufacturing.

track top-notch with CAR-Ts to is excited fully So I make our is next because completion so of think the manufacturing facility. in-house and really manufacturing starting the year our at we're same facility that's Cellectis that think why But the of I by are targets somewhat manufactured the And that build their our of out on the being as Allogene it's own great is manufacturing well. finishing partner partners.

fully then Our programs. our proprietary second think, is freedom And obviously gives that for focus manufactured the on Carrie. proprietary Cellectis, because question, us I targets the by are to

maybe you Raj, can the Sorry, the of just repeat second part question.

Carrie Brownstein

repeat Can you question? the

Raju Prasad

Yes, sorry.

because dose Dose alemtuzumab Firstly, the dose you of Level forward? that and plus disclose the moving is enrollment the X finding ongoing. around kind Can dose alemtuzumab with strategy

Carrie Brownstein

absolutely. Yes,

So was we've X way that Dose was at dose cells Level without cells kg. without was split alemtuzumab, that we it designed disclosed Level would trial X within we X, after without enroll cleared were kg starting the we the independently. would the before then per million X XXX,XXX Dose into – Level cohorts we per The for level, Dose trial Dose so X Level

alemtuzumab if of we alemtuzumab. with forward where to, able without starting And Level to we're have or are now we dose the that that's X escalate trial. chose Dose on we So to side repeat move now. And

Raju Prasad

And the are that alemtuzumab with using? dose you

Carrie Brownstein

what but at, we're Sure. disclosed I using, we're mean, between somewhere Allogene we starting haven't in been. where has

XX for we're doing So milligrams. trial, this

Raju Prasad

seen Got you've the moving or them, it. And would you what potentially protocol with there? anticipate given up in what's

Carrie Brownstein

dose significant start the XX infectious typically but gone around see less milligrams, XXX, their We speaking at transplant and came to think not transplant to done and literature, my probably a milligrams. literature, the but based literature. you Yes, And dose the than have I've myself. need and we XXX transplant on review up see, I do know mean, of higher others with with problems from scouring our I you’ve that we'd KOLs than just you

we So, right population, perspective, without want starting I somewhere But to see, from we risk obviously, think always see infection. I don't prudent need what think depletion given to you change. kind overstepping wanted in a we're of could we place. to of the patient with the we you seemed the that start the And of range in need really get what potential

Raju Prasad

given Got all XX it. that a split or? is And dosing

Carrie Brownstein

up split days. couple It over of a

Raju Prasad

Okay.

Carrie Brownstein

easy and left to to issues related and with in give reactions it things for you open alemtuzumab we that that And because we and the infusion comes have some – make physicians not as also know, wanted different formulations it patients things. it's because

some So and to things physicians up like titrate like that.

it's to up. really much total on so it's the So us, not how dose that split matters,

Raju Prasad

really That's Thank Great. helpful. you.

Carrie Brownstein

so Sure. question. Thank much for you the

Operator

questions. next The proceed of Madhu from your Please with Kumar is Baird. question

Madhu Kumar

thoughts in thanks. B-ALL? And in Hey, kind questions I what of noise early. some might about reactivation little regimens seen a of on or DLBCL, for But reactivation, impact I far protocols thinking then given what employing CAR-T you've monitoring have missed so bit given apologize these are CDXX just your CAR-Ts virus of of kind latent your patients lymphodepletion around the screening employing now? did in you're the some either that latent how of virus

Simon Harnest

directly so These hand Carrie. to I'll two much, Thank you over great are it questions. Madhu.

Carrie Brownstein

that. expected I

So really yes. so, good question,

particularly something forward. for development think about our clinical It's CDXX. sense we lymphoma, will move we as DLBCL B-cell in makes plans, So,

we would expressed expect earlier I competition not as it's well think, in and it's it's NHL there a, now. right talked that as going no highly That is about much target reason, in as story as B-cell that ALL. a quite said, as much as in with, the you same there's on

approval. could have and fast-track give potential for does for patients failed an other opportunity provide So it who things

it's we So something are it's thinking that And a about. question. very good

In where other want because so you are for that it, field. of really patients and well that latent we'd right been study paying problems. give other for everybody, virus, it unlike there current something all medication some in and medications isn't in isn't HHVX prophylaxis, particularly can get with we're has is and that of your exposed point terms has for right, issues an as anything prophylaxis all now something living HHVX only works has to one of HHVX attention and of There's area issue. which almost there absolutely, and in Unfortunately, really viruses, at And these the really which it's viruses these them, to. is life their some these an HHVX, to kidney it

reactivation something So to, have start on make see that have need to closely are we pay we of something screened happen, and viruses they you quickly. these to where and some it is sure reactivation as pounced that that does patients to monitored attention something when and is watch, we to for

as management potential the our something different it ensure to absolutely. without we're to, infections, trial that these monitoring So have pay with all latent you other or can incorporated is these that these monitoring management problems. in see and frankly, well patients quite of giving we opportunistic to of infections alemtuzumab And best virus obvious attention into and as

So product. the developing it in does not of get our way

Madhu Kumar

if Okay, seen hasn't great. for Joe it, anyone Biden. they Pennsylvania And called,

as so decision desk. of And he's States been the United called President by

Carrie Brownstein

What?

Operator

is from Kelly of proceed your question. question next Jefferies. The Shi with Please

Kelly Shi

And expression CDXX information you CDXX like, for curious the you the probably is, CDXX and strategy my probably questions therapy? CDXX better on level guys the I a response suggest as if levels, correlates I of treated for perspective, would I biology Biren any taking versus Thank agent I'm it know on patients. have Jefferies. thank expression progress. Hi, could see than And also early. actually congrats And as expression from the the you is another question Kelly say from level this if the of wonder targeted it's CDXX you. such expression CDXX targeted single strategy you do be early sign level. have with

Simon Harnest

Kelly. I'll CDXX obviously Carrie, because go picked well and Very, expressed. think very for we but hand Thanks, to a important Carrie, it's very, we question, it reason ahead. very over

Carrie Brownstein

sorry. still last reeling I'm from the I'm comment. Yes, like

Kelly Shi

can. I repeat? to want you Do

Carrie Brownstein

And do part. just I heard part again. the second Yes, the first

Kelly Shi

Okay.

between level So correlation see you CDXX you do any is, a expression question – see the first the do responses? and

Carrie Brownstein

that we're I water, make throwing bath looked requirement higher the part have a do certain out level speak. want we first we to not Yes, haven't we study to to on because sure the get or baby at with of that of mean, a the yet. so the

trial, will haven't of stages we later but we point we we are at, into because correlation, the is a be as in CDXX a So of as think said, part it think significant done believe in looking expression in I at in malignancies the then as of something it. the We go program. this and the ALL second target it's far question, in we Simon And an CDXX, important as B-cell general. requiring

just back many there But also rituximab to became important. years much. was antibody, that think do the the CDXX ago, just why up B-cell happened that that's for I CDXX was think malignancies kind in being number part how just it one of kind didn't really in is reason, CDXX. to because target CDXX ended to of, And of similar so very I epratuzumab

will because now, development, given of CDXX, are a fail something expression. in we as that feel without often, So think expressed. that ubiquitously it's we relapse does out really of the but CDXXs it's important given who favor a patients they little strongly be really opportunity And CDXX fell And first. really a it CDXX right way I they target, bit, for provide is ahead exciting an know

it's think that be goal I an really a So shots provide and multiple important we does place for approval. think to on

Kelly Shi

Okay. you. That's Thank very helpful.

Carrie Brownstein

Thank so much. you

Operator

questions call to back over closing the Simon There for time. would are additional I remarks. to like Harnest at now this turn no

Simon Harnest

again, much company unique moment showing of Cellectis. on Thank a appreciate so our We Yes. think we're your call. lot really interest in very programs. we And at to proprietary really the everyone the you to data on start a for

a any So to much. you posted us if would have you contact questions like follow-up call. feel we'll so Thank or keep and free further you

Operator

concludes This conference. today's

disconnect Thank participation. now your lines. your may You for you

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