CLLS - Earnings call transcript Q2 2022

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Operator

Good morning, everyone, and welcome to the Cellectis Second Quarter 2020 Earnings Call. At this time, all participants are in listen-only-mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. Please be aware that today's conference call is being recorded. I'd now like to introduce the first speaker Arthur Stril, Chief Business Officer.

begin. may You

Arthur Stril

welcome, update and Cellectis quarter second Good financial everyone results corporate and conference XXXX morning, to call.

months Bing reporting second Executive its Joining me Dr. and on Officer. Chief are update. will is report so absent and speaking release prepared six release Cellectis with quarter press Chief on Dr. the Dr. Officer; for today's Brownstein on filed the Andre press about interim ended XXXX. call Choulika, its evening, our our XX, today results Yesterday a program Wang, financial and Financial our I call, cellectis.com. remarks June be our The period and issued website report at available are CAR-T

SEC recent of XX-F from our forecasted. in can filed including most management Andre. financial the differ and be to the those with found including risks year selective manufacturing, statements, reported current subject I and over would these to time. report, to financial filings ending to description to available outlook assumptions As or reminder, to A our management, actual cause the and based Securities the and for partners are a provided on licensed in regulatory These Cellectis Form forward results product the regarding December Commission XX, call its publicly development from information time which subsequent plans. and to are management's and that on now on XXXX, makes may we our report will Exchange information expectations statements with otherwise and the addition uncertainties make risks currently turn by like

Andre Choulika

for gene notable progress we joining sponsored forward being everyone, clinical selective candidate with take preclinical week, in will those and has our tumor trial. thank cell CDXX trials therapy. product or population and product advantages patients to may manufacturing an UCARTXXxXX for Like directed validated transfer is allogeneic CDXX Thank to dose UCARTXXxXX addressable into fully potential our proud the data development, and are and the targeting breadth targeting. investigational new patient our application development. lymphoma. our potential a three tool Phase CDXX targets with integrated end-to-end alternative cell to be you, therapy drug and candidate enter Arthur. and in-house the in product transformation B-cell The from candidate of These patients Targeting clinical This our announce cell also into Cellectis product you, and and be company discovery first us showcasing killing escalation programs. malignancies and increases the the for refractory to non-Hodgkin's steps enrolling our first of today. developed UCARTXXxXX, GMP increase I morning, Good program to make provide antigen with exciting CAR-T and and FDA enhance will clearance development very relapsed therapeutic

of by allogeneic graft the challenges followed the Demer versus reaction. This CAR and CAR the cell, communication may research American our tissue of the oral host of These level promising, novel they Society without by CAR versus cell to immuno-evasive T quarter, also cells data at our T is we're which Cell reaction in are immune very nature Therapy. on of enabling cells main universal graft presentation the first immune address pleased Gene the depletion following T and host via of proliferation attacking system host publish universal evasive host the

natural cell our in become cells the by cures cell While universal inactivation CAR invisible before of tumor setting could addressed cells use for the This the to allogeneic T CAR enable transiently immune T patients. CAR receptor, and expression system. versus to patient of of an and allogeneic prevention T being benefit cells, could readily broad cell T universal cells, wider enable rejected a T eradicate host reaction by approach them the of to allowing graft can engineering be the of T-alpha population

also Directors. leadership we Axel-Sven Annual quarter, continue This expand and to as that appointed the Donald been team, announced Company's for Cellectis have Malkomes incredible Meeting Board Shareholders our our during Dr. Bergstrom Director of

leaders services work We selective are to very sector Board. pleased both welcome Mr. They Dr. in [ph] to health Malkomes are industry Bergstrom Cellectis. of teas experience who care to the the care brings and to and with financial continue with our the both decades and health

that perspective of one confident cell continue to company. they and end-to-end valued progress We meaningful will therapy as the few becoming we and provide are toward gene

call I ahead. would time Officer, of like and Chief Arthur go will overview give to sponsored turn clinical over three who the Business trials product the line. please our to Stril, Now Arthur, precritical an

Arthur Stril

Thank Andre. you,

multiple we the one look We of at patients preconditioning refractory three level kg myeloma least to with million study fully or per dose year at the to robust stage X by set these relapsed UCARTCSX from clinical when The MELANI-XX relapsed our acute in and and in plan alemtuzumab is make clinic. X sharing currently in and evaluating enrolling end X, the the facility at meaningful product or Raleigh BALLI-XX dose patients regimen. Our administration in-house study, leukemia allogeneic with regimen. initiate is cells million continue CAR-T programs enrolling data the patients have forward cell half level a patients from of X, We preconditioning UCARTXX year. currently The candidates cyclophosphamide of refractory second fludarabine kg this with fludarabine, with of progress cells data lymphoblastic will B-cell UCARTXX in clinical to per evaluating batches cyclophosphamide to present. manufactured

the are dual UCARTXXxXX developed UCARTXXxXX, mediated features mentioned, clearance IND product T allogeneic relapsed Andre as first disruptions with our or host persistence. preconditioning product disease versus CAR-T non-Hodgkin lymphoma. antibody refractory expansion graft for attract to for Lastly, cell CDXX candidate risk engraftment, to and TALEN been candidate the gene of FDA monoclonal of we enhance the the the announce CAR pleased CDXX the of being permit patients both and to use gene that shown to to reduce has directed in

We NATALEE the to in refractory non-Hodgkin UCARTXXxXX second of start patients or XX extremely relapsed lymphoma evaluating this study, the excited half in with are year.

The XXXX, ALLO-XXX will in need announced trials relapsed/refractory patients This with data in treatment large ALLO-XXXA relapsed/refractory in Allogene the highlight myeloma. Chemistry track ALLO-XXXA Phase with the myeloma based quarter to patients for ALLO-XXXA in on our lymphoma for lymphoma. trial pivotal failed in FDA who advanced also CDXX resumed launch follows relapsed/refractory cell cell Allogene X with June, partnerships trial also single-arm and announced designation the multiple B the XXXX in X resumed Lymphoma on re-opened from ALPHA clinical large proved pretreated be portion or offering design the on our previously large TurboCAR™ ALPHAX for FDA relapsed/refractory move also for announced In heavily trial. at an and while other treatment ALLO-XXX. May to Designation multiple collaboration the Manufacturing now also trial the finalizing B-cell in and BCMA They previously had Controls have Iovance Advanced to that to positive the and B-cell Allogene announced discussions previously Cellectis. targeting that potential for In Therapy I relapsed/refractory directed Regenerative trial to for mid-year ALLO-XXX Orphan to pivotal UNIVERSAL the clear prepares the with unmet the I X said granted and enrollment Allogene and was that with exciting Medicine research IGNITE to Cytovia. Allogene trial requirement. that of ALLO-XXXA therapies FDA address with the patients patients goal of ALPHAX lymphoma. Cell of RMAT ALPHAX Drug Enrollment renal with Large relapsed/refractory the begin candidate, Phase targeting Phase metastatic of patients of B-cell enrollment trial of that carcinoma. with ALLO-XXXA is the granted Designation the

leverage activation TALEN three this began gene technology. IOV-GMX-XXX the recruitment Iovance prior progressed IOV-XXXX. of IOV-XXXX dosing human looks treated of a cell an second patients in disease Iovance combination PD-X PD-X for anti-PD-X it murine lines up of first with combination signaling includes cell alone inactivated advanced of previously In products, whether and the or with of patients and antitumor first cancer study cell patient metastatic model of quarter, end to cohorts, This within interruption IOV-XXXX IOV-GMX-XXX a of whose forward patients has announced activity therapy patients' melanoma anti after a year. lung to editing PD-X TIL is single therapy. the melanoma, study non-small in may the IO-XXXX were incorporates and non-edited the to who site was the in the study therapy that antibodies. The half two therapy. superior

Finally, robust pipeline Iovance clinic. the has advancing a towards research

success genetic the double modifications knock-out technology, targets program. editing using genetic of several Following in preclinical TALEN including are for IO-XXXX the gene studies

iPSCs edited development is and to has Cytovia cells which manner. pluripotent and research safe to developed Our stem Cytovia collaboration TALEN edit with induced in NK CAR-NK TALEN is using custom develop Cellectis effective and a cells, progressing.

gene continues for second Wang, the is to announcements editing, with has Bing for NK that, that of that at Additionally, company reiterate I hand XXXX. conferences the like the later Dr. generated present iPSC-derived would Chief provide the Financial expects TALEN-edited preclinical to promising scientific Cellectis an overview With opportunity. upcoming call business which Cytovia of financials more These choice data our year. technology expanded of over it quarter to TALEN for of cells to this once Officer,

Bing Wang

$X consolidated and million early cash financial operating and of cash on is this The as current cash, assets position of of million of fund operations equivalents million income financial other of R&D per consolidated $XXX activities to related I current stand-alone primarily of $X including million Based Cellectis of sufficient a to cash shareholders partially of XXXX XXXX. and million net net increase in driven into prefinancing Calyxt, of six in as Cellectis, and quarter XXXX. Arthur. XXXX. to mainly XX, to loss expenses, overview XX, share June projections, to $X cash, the to June Based anticipate Cellectis compensation partially capital per a be compared offset December reflects million raise the of December of Cellectis, $XXX and was position excluding the $XX of share was on plan restricted of million million XXXX attributable The and plans, Calyxt tax cash The position six of million adjusted by tax The The net of to an second at expense runway by and cash first shareholders loss credit the capital cash per months $XX compared investing $XX million first Cellectis, by Cellectis a six to in expenditure to was $XX current as net $XX cash stock-based loss months decrease share million to and XXXX, in partially first XXXX. X $XX were or in Cellectis. month was between million million consolidated six financial attributable difference I first $XXX $XX and negative attributable million loss XXXX month in assets Calyxt used Calyxt million million net XXXX, our XXXX $X.XX and loss of or decrease of us Calyxt, This $XXX of credit of XXXX. early in of XX, in XXXX. gain a the a we XXXX, compared current of foreign at would noncash our million the $X exchange and Calyxt, net $X.XX received Cellectis, excluding of offset that prefinancing. excluding equivalents, financials was to XX, was including you, brief into like or of related XXXX, impact, $XX compared net cash our Thank to of per financing cash and will compared financial restricted million This $X the as for offset research used Calyxt million, received shareholders flow highlight lease financials, research in loss to $X.XX operating, million of $X increase $XX $X.XX cash loss in flow excluding XXXX. as million. months of and by share first XXXX. operating take or the in a $XX leases in will a in in provide revenue expected $XX

wholly the developing our in owned clinic on pipeline operating product We state-of-the-art our Raleigh. in of facilities are and our in and manufacturing candidates spending Paris deep focused cash,

corporate us Andre. focus and very enable remains that in efficient you will Thank growth infrastructure Our maintaining spend. on an more back G&A much, limited to

Andre Choulika

CAR true hematological with These continue trials cell of ability Cellectis. advance promising our Cellectis studies partners, to open how Thank XXXX. this and will to with product, progress you, to gene end-to-end clearly the patients hard-to-treat cell out with T of T and CAR With To call, reiterate close I candidates, and our our are trial allogeneic of show our us of our as and the clinical we we the cancer for capabilities our a in allogeneic technology our of excited we call To Allogene technologies ongoing clinical progress clinical cell for strongly positioning patients our have Most continued like make believe this scientific forefront Cellectis, medical Bing. sponsored our to updates potential utilizing to those close at steps milestones the we and becoming Q&A. lead company. pipeline that. XXX developed the the would therapy. like manufacturing about At field field shift paradigm would with make in for this quarter, that, that therapy the closer in-house to date, to us remainder been and treated I three and licensed upcoming malignancies Servier,

Operator

Thank Instructions] proceed the of first Please with comes from Our you. Barclays. with your Gena line question. [Operator question Wang

Gena Wang

on Thank questions. Congrats my you for clearance. taking the R&D

be including also or a little and clinical dose more to Now you second UCARTXXxXX your thoughts a able your will is since It design, T publication. impressive can initial trial start trial this regarding half population bit which have regarding data. they is very line share related then that the Nature would color year, the CDXX to prior initial the specifically And patient or CAR therapy? whether - question second my Com clinical

wondering, So kind have due - IT X-M and do approach of you knockout? for you HLA-E-knocking beta have what your

Arthur Stril

Gena, these is two start will the questions Thank over this Arthur, call. This I to Andre. and you so hand much, questions great for think to I

So I Andre can now. don't for we think hear

So take I will the first question.

and This is excited first developed UCARTXXxXX, to have IND the So manufactured Cellectis. we're allogeneic on extremely the CAR-T indeed the cleared. design end-to-end at

forward a it's company, to this for we So the and to milestone administering patients. definitely product look fantastic

the other versus the that at strong innovation Cellectis. And the trial will haven't it your disclosed question around AlloCAR dual will T we We we all believe definitely, the and this NHL yet, we on differentiated very relapsed/refractory I strongly full because clinical in this lymphoma doing is disclosing protect strive in be trial approach design, have the this patients. of trial targeting said started. the that space, as IT, clinical do the getting fact in will later year a particular, that be to But differentiated targets non-Hodgkin we is mean, be full So that CDXX design we're

have the space on malignancies the on CAR-T. this the And persistence, these that indeed well hem [indiscernible] to tumor definitely in very strong around HLA-E space. exciting or And us we the approach strong knockout technologies that approach We in that enhancing in arsenal protection have a think solid indication depending disclosed allow CDXX have adjust target we of and protection a the for is we to the that Com. Nature as gene

Gena Wang

you. Thank

Operator

with Yigal comes Citi. of question your with next from proceed question. the Nochomovitz Our line Please

Ashiq Mubarack

Yigal. Mubarack team. Hi, is my for taking Thanks for questions. Ashiq on This

you're just thinking how curious starting escalation dose about thinking generally. just study. the I'm about XXxXX, For

seen doses other range think a kind of we've I of from therapies. some starting of the wide cell

your So different maybe can I'm you dual at just there? start, other And make just comment where generally, out you kind dose all of those to might cell targeting curious escalation you'll how all? more therapies if antigen at relative think

Arthur Stril

a lot for Yeah. question. Thanks this

Andre take So it, will Arthur. this disconnected, I so is has

dose, terms dual question, the starting think both lympho well of of a the it's indeed, the targeting of CAR-T. due great and to design, as I we've clinical the So lot in trial as nature of a depletion into put regimen, [indiscernible] the field,

again, stage, the this dose. we not at So are disclosing exact

course we and this so say due be the we'll escalation, in has dual I now, will what since yet this standard are design. trial when started. is dose a is safely, can competitive dose for think But field design, trial the right a particular expansion targeting, we very disclosing do in not

Ashiq Mubarack

Makes if more I one And can Okay. sense. UCARTXX. ask then about maybe

previously being version. that I product indicated fully you're the you've alluded compared you've you've think And to version with potent switching before. to manufactured your think in-house this used more I

the was to even dose just as version to escalate you'll road? if wondering, commercial-ready the make the or those dose any you version? deescalate down iterations I over, ones? And escalation Or - work if for So are further this will do [ph] regimen do a any adjustments there you some switch bit. dose there be comparability maybe need maybe Thanks. And additional will to is have

Arthur Stril

you. excellent questions Thank these UCARTXX. on are And

I think Andre reconnected.

Andre, this? want the So again do take you to on so not, will question UCARTXX. I Currently take

from the you're what at CMO So what The basically our potent is manufactured UCARTXX, we we've past. had in on more than seen right. absolutely product

effect same of the case, benefit to therefore, FDA cost goods. reduced that that's to could will our had of smaller with But comparability an the on the the a added Raleigh and definitely potent asked So we And is this interment internal acknowledge this happen milestone testimony escalation. the more with is that a be there obviously - a dose is product the We if what possibility FDA us with big to discussion definitely manufacturing the and and to capabilities. will have lead deescalate. dose

manufactured delay CMO. this our not trial, that we still previous and the UCARTXX the of be if will able data to rely will was version on the happens, So that from at

Ashiq Mubarack

for the color Okay. Thanks all Great.

Arthur Stril

Sure.

Operator

question Please comes from with proceed the next Our line Kelly of Jefferies. your with Shi question.

Unidentified Analyst

for for is question. This Thank you taking Shi. Dave our Hi. on Kelly

on quick a XX just So months. next plan the for overall

said what months. will you that in next least You be forward set so at the one look from investors XX should disclosing data, of

color Additionally, update? ALLO-XXX on on pivotal Allogene can ALLO-XXX trials add data you and from Thank you. of milestones

Arthur Stril

Great. much. so Thank you

time. try will on Andre another We are the Andre, you line?

Andre Choulika

you, Arthur… Thank

Arthur Stril

hear you me? can Actually, Yes.

Okay.

seeing implant, and like also that we’re detail also the the think first to allogeneic disclosed have Allogene total, their stage and in that been that part but BLA our the ALLO-XXXA disclosed are expect there and $XXX Allogene. is to BLA well, the the trial, that of milestone, And of both ride we confidentiality but part we allogeneic from pivotal start milestone course, [indiscernible] Allogene trial milestones approximately has excited to CAR confidential these the year also is So this pace of total are And post-commercial - with trial not with like up in potentially the million totally we the is are a soon. them, company have that out and the the and are going they details have not by the and think part milestones, data know are the is between excited million also to think very CAR-T starting us phase we milestones data. we CAR-T, a next I and only - about also there there clinical autologous trial that receive the their to BCMA to the very and have milestones. we're CDXX to total the of of and - pain T, preclinical and pivotal post-commercialization clinical $XXX and not to very But first

other the the there Allogene. we T, than by CAR are cone course, also has this believe BCMA On We Of very part, they’ve autologous. definitely data by trials [indiscernible] that like best excited are that matches, BCMA obtained been like data better

change CAR-T also Given all believe that performance industry. of n cell the and commercial performance the being two will definitely on logistics, potential the the began - to the difficulty these the for and we change and physicians the

Unidentified Analyst

you Thank

Operator

next Our your Oppenheimer. the question Singh proceed question. of Hartaj from with line with comes Please

Hartaj Singh

Great. you're And with might trial. I Thank to a but you just have if next some might the good of CARTXX I signal to and some you down you've at XXX, that the seen product XX door that in year Andre, projects two team from in thinking get you could question. a know Are have steel you next a Paris, that maybe move the for helping how Andre, data looking the been want data with Thank of over there, those trials CSX go dose like and designed to tumor out projects still - away the a type the expansion suggest, in you the readouts pivotal those of then really XXX, of quick the from out, see tanks, and maybe to months? reception-wise. of question, But regards? end essentially one then the for on And good we question. play year, some assuming

Arthur Stril

Thank question. for Always you the much, so Hartaj, great.

you do want take usual, this, Andre? to As

Andre Choulika

no to I continue, to want can I Well, problem. get started, try

Arthur Stril

Okay. I get can started.

indication in trials have, definitely, expansion the we've the think, dose not for options expansion product internal when scarcity our switch that depending to being Hartaj We very with our production, to we indication, this to there the the Phase to Andre, I/II once example, add And phase of the additional But be a to and and the to that? closer on, that why on don't the is don't data our could and the so we completely color there that's I if of BLA, escalation dose So and spot to definitely be you BLA. the in can the manufactured specific. for think know, want have designed facility for and recommended get - Raleigh unmet we registrational. data from expansion and found that potential blocks, only room and switch trial registrational. autologous, any the the your potentially file will Raleigh beyond very high control those product facility I we we own of dose Phase UCARTXX need a is II CDXX because we dose two decided CMO,

Andre Choulika

like Id one add Yes. to thing.

by question. developing we've started that First patients of The a is CART ago, seven of now, then XX dosing since been been thing numbers first the way, - great series like years from ago, seven that years XXXX, CAR, renamed the six like of has all, it's allogeneic from there n in a so UCARTXX ALLO-XXX,we then, was more BCMA like years CAR-T, ago and then lot the like And was of then then plate. to there's a as certain BCMA, say, such survey, we CAR-T targets it's things our went And there like is these X to and derisk think moving CSX X brilliantly license plenty are became of but on that them. and very Pfizer, to we're like XXxXX, now developing then X XX like for targets Allergen let's then are, we Allogene we [indiscernible] XX. years

these a are multiple XX potential myeloma. plan which targets AML XXX CAR-T and CSX and ones derisked or fairly should think Docer as are Some the again, X see we CDXX, XXxXX you CDXX is for [ph] why that this like XXxXX and straightforward, are like such and for more

data the in space. the that and in several indication and this hard-to-treat future NOs see X are some we there is challenged times, is complex being target potentially expect course, target to Of

Hartaj Singh

call. Great. in Thanks, for the answers the Andrew. everyone, Thanks,

Arthur Stril

Thanks, Hartaj.

Operator

Allen Baird. of Please comes proceed with Next Jack with line the your from question question.

Jack Allen

taking just I the so question you and Thank questions. on for the congratulations quick have two much progress.

on wanted enrollment dose many sounds X. much you that be how study? at And study was But the hear I add asset far you're program, the for dose given proof quickly disclosed have maybe then the we you as patients advance hear I'd for with to more that It you doses X know you're going going? hoping potentially how as thoughts looking level concept about you any in well. CSX design taking as reach as question. color the additional to what XXxXX,, And On level clinic. is to some of to just like I I Thank to been love could enter how and as so have is to

Arthur Stril

so and in. Jack, you chime and Andre definitely much, I can can start Thank

So for UCART again, CSX, patient disclosing we're numbers. not individual

per the thing mentioned is million is kg. as can we that think I the say DLX, in call, X that

levels it's to quite other other dose already T. high the of CAR the So compared

So we the level higher. at dose that started that trial was

that there So towards safely indication of say trial And itself. one is UCARTXXxXX, can definitely design, the specifics without give for we then clinical again, we what into can think, trial by I is going overall is very large unmet this opportunities. to very is moved a options line, patient second and options limited actually CDXX that refractory population once patients the and need a are at stage there to because have very target

offer derisked CDXX, only receive but to CDXX autologous potentially not alternative in from not targets the also not patient the a and a meaningful And so in will patients particular that to CDXX could most relapse taken the two that are XX, we've XX, that field.

enrollment. a to Andre, is large be any add? opportunity, to swift So we population, there large believe and a conducive this thoughts could a patient

Andre Choulika

for U.S. trials for of not in enrollment is space yes like the is fast. very DOX, CSX, Yes, a the But lot in there the

United So have physicians is in we we and is there States enrollment having - difficult. is are regions, to the fastest talk Tavailable CAR numerous we patients, lot of currently that a the for it's something not this their and

also maybe to countries. expand like plan the So to other is

Jack Allen

Great color. lot. a Thanks Great.

Operator

of with with Please question. proceed comes Our David line Dai the next your SMBC. from question

David Dai

question to I Great. Thanks my for progress. taking current add want also and my the congratulations to

Andre. questions for quick two So me,

the going to dose the one you the in And been expectations enrolled half XXxXX, this data have so far? in I year. be some second could just is remind second of around question the us many first you're just the from patients is just providing conditioning So X the question FCA around regimen know how then Level with of programs.

So just you. in what can terms to expect? position Thank you data of us just

Arthur Stril

Andre, this? you take want to

Andre Choulika

missed UCARTXX - unlike that of it. I piece the Is little actually,

Okay.

DLX, DLX DLX, that there been plan completed program is FCA, with to per trying at made bridge the level, on is a in-house. has patients few the DLX, So so the three with patients

our completed on sides. SCA with the and at So full both all FCE Raleigh facility goal the Park globally, has Park been

So that's to done. the we expansion. course, of also. hope, move patients, followed we that’s expecting the your that whole And thing start believe has - dosing that [ph] we're answers to forward But If in question. been potential and Raleigh going now

can math. do you think I the

Operator

question. Our Silvan Please the from your Securities. of line JMP next with with question comes proceed Tuerkcan

Silvan Tuerkcan

you us CAR-T. space the you of would Maybe Thank target XX, There XXxXX, Yeah, was regulators you about hello. be of And provide to is was CAR-T the that with Raleigh Roche And here? my some second to differences, It the quarter one of as Could exact is for is obviously, to tell perhaps be mechanics deal Roche getting just would rather part we needs time bit done the idea? into what the the Congrats could Could deal - that. on about and other more they now. potency that required CDXX comparability. now UCARTXX. clinic, And that? the assay you. into place? question with the or a why [ph] mechanics material there the what remind recently, get for and question. large and you obviously, interactions taking around in were us the a my of just thanks all say color there. we the Are question then are of think assays I XX, better a CDXX And great interesting little talking do last a if why still

Arthur Stril

Silvan. the Raleigh start questions, much, so you Thank one. Great and I can Yeah. on

has steps are centers FDA regulators had order we mentioned manufacturer This then so timely definitely, from looking they understand our before, safely the the in This basically have ROBs, an CMO then product manufactured can IND Raleigh a to we their and with would the the go approve product. exactly to transitioning be to administer amendment filing So interactions and for what to in - as product. good the with the we clinical understanding through that product. manufactured Raleigh

this of all So undergoing. is

in first go we're product to And able that - this the dose on Raleigh please assays with patients in half I happen, second make yes, place think the all We year. confident that we'll have ahead. be of the the Andre, to and

Andre Choulika

On of to into reasons. of going the for straightforward. the the this potency I'm not is details numerous size it quite get like assay

the cetera. First doing there's anyone. definitely, to but - of I think the they're a it's can you really of everything the plus, potency, that type of performance essentially assays, of interferon well, it's these very performing all, number they et products. and disclose not do two the in not And recycling potency release we're not number gamma of expansion comparable. sure I'm releases, obtain that of idea bad, I that broad quite don't division product, cells, not and interesting cell the time to doesn't performance do it's But like It's - of the comparabilities. stand. between to good. excited totally the the of it we're do, Globally, see want totally And very of And of is we the of gives comparability so this number could all that of potential the recycling that killing for the and these I the type think perforins granzymes

few there and do was Silvan, excuse potentially what - the So or below we that's a me. that's get. necessity you technical question, like rule not about you that extend of why doses what like a is your was beginning There do, of do potential like question a

Silvan Tuerkcan

There also re-targets the here was targeting dual and – what Roche target just and which are their partnership why? basically rationale a question around the CDXX, CAR-T,

Andre Choulika

the in start we Well, the probably of will they the CART and and most will received arrive allogenic XX see rationale at - CDXX patients behind I deliver natologist. CAR-T a the the that and of fact don't space full

allergen will them. the course, approved CAR-T Of by be

And Of course, et cetera, you come you et another then where yet [indiscernible] have already with cetera, are the CAR-T performance quite et CDXX you cetera. good. see

CDXXxXX, to CDXX compared it's CAR-T adding I not another XX, have the CAR-T. CDXX superiority you give either think them or the show relapses they're of going and a more where to way to interesting other a to all So CDXX

approach. really surprised have CDXX, give but of of them the is high, we So type of so believe to a that this don't reaction its performance better I'm the CAR-T

Silvan Tuerkcan

Thanks for you. taking Thank Great. my questions.

Arthur Stril

Silvan. you, Thank

Operator

with Wells comes Our next your Abbott Fargo. proceed question Nicolas from question. Please the of line with

Nicolas Abbott

taking for Thanks morning. the questions. Good

one, The UCARTXX. first just on

do that? you IND when filed do if to So have not, the and amendment you intend

Arthur Stril

Andre?

Andre Choulika

could at It actually, time the broke up the excuse me. you just question, repeat

Nicolas Abbott

Yes. Andre.

when first you The think IND you filed the one amendment you IND, and for file that? that you if the have do you'll if filed not, if UCARTXX,

Andre Choulika

XX? For

Nicolas Abbott

Yes.

Andre Choulika

should see you Well, than to expect dosing, hope it's I patient later… well, - sooner

Nicolas Abbott

Okay…

Andre Choulika

We are not delayed.

Nicolas Abbott

Okay…

Andre Choulika

time. on We’re

Nicolas Abbott

level was X.X dose have I sort us X. X, it didn't dose dose on you I that dose - prepared provide X, with Can had X? X, going just missed update you I comments The X, be level But precisely before an recall it. was are completed to may to you you Arthurs think hear level of where jumping X. an on intermediate next X.

Andre Choulika

actually, series in interesting so cautious an being by X could concerned CART Level too Well, that that are those the CRS the the be dose type this of we with high of been dose we very we've we far, because think X, had And dose. and past. Level

we repeat there or on target, like quite trying intermediate it's that maybe not giving reactive like think something between a dose I dose. interment an two, So two And it's a disease. an because potentially, like the are an and this is easy

that be and I can dose to that DLX are to not be dosed. of the high or simple but we're details for on – go interesting orders in through orders maybe I'm T that DLX the all CAR level, So going think it this, so

Nicolas Abbott

Right. Understood.

like an you file to repeat filed X.X try to maybe Level then amendment need try, dosing? an you amendment do dose or So

Andre Choulika

to you can been a It's - and you this. file with delayed DLX, you cautious to we're that. do approach, repeat, on how we've very challenging like and it this, need just amendment a not but do still remains -

considering, not it. doing we're just we're Something but

Nicolas Abbott

Okay. Thank you.

Operator

Schuster proceed Blair. with the next question. Brooke line Please Our William comes from question [ph] of your with

Unidentified Analyst

for I the how on Raj on on run wondering And differs the process color a the regarding two? details if single Schuster for had the Brooke the yields Prasad. question is could This manufacturing manufacturing from was target between provide of dual any more products? you I UCARTXXxXX.

Arthur Stril

great can start. definitely I Thank a and is you, question, Brooke. This

so we that - facility. platform that dual XX CSX the at CAR-T our So developed improvements uses due with the There construct targeting. in allogeneic from UCARTXXxXX some the viral come Raleigh is specificities same same all in-house manufacturing vector to the Cellectis, XXX, at definitely from manufacturing the the process we manufacturing it

that construct we most construct scale. get this CARTs, does value in significant not the So we both carry yields to distributed is was therapy And as allogeneic for at - proposition have we can that be off-the-shelf bicistronic that which and the use modify order allogeneic optimal found industrialized this the the a for approach. all getting to true of allogeneic, an found

So this and have of for cater CAR to But get hundreds improvements there the getting we manufacturing similar yields process Ts. we're was lot to that of definitely dual for other to targeting a per we found the that approach. could doses campaign

Andre Choulika

you lentiviral 'XX, you or the CDXX making technician If if two, not realize. that dual you you will take is don't for it example, UCARTXX versus exactly a vector XX containing by on UCARTXXxXX - if for try

The process. other the differs tailing like exactly it's et sure the at that both XX on at the CARTs notwithstanding on is cetera. the be present, in or So only to QC targets thing and XX the end are that expressed, same that fact

to that's itself, if in the So the [ph] manufacturing you slightly sure the you It's have lenti is that dual, don't the there be know. contained more you know process what's then but don't process exactly QC same. for a during complex UCARTXXxXX

Unidentified Analyst

Okay, awesome. Thank you.

Operator

Goldman the from comes of proceed question Salveen last Sachs. Richter with Please your our line with And question.

Unidentified Analyst

enrollment Are And regimen? the you. headwinds for on gene is to should the any Could you be able portfolio? elaborate you a use CDXX given This we of? are morning. preconditioning CDXXxXX, patient toxic there then good less Hey, on Matt aware Salveen. the on across rates disruption, of Thank

Arthur Stril

Great Matt. questions. Andre? you, Thank

Andre Choulika

Well, patient so for the three flow reasons across the enrollment been far trials. numerous has

is non-Hodgkin's X,XXX. a acute in - versus XX like lymphoblastic patients XXX,XXX XXX,XXX every the in compared U.S. to So lymphoma, U.S. there's X,XXX. like the year patients leukemia in versus disease rare

quite it's So huge.

So - the been it's has been enrollment slow.

are in a said also, as there this I TSX, lot space. products of before, the On

and So the numerous saves is for there are recruiting tight DLX. also trials are quite lower like like criteria the patients that criteria, reasons

done We DLX for hole. And the to X have following treat. a is 'XX for X, CSX completed still X, they're for but QX disease a difficult

lot completed and as I to DLX, DLX selection also patient is DLX time. before. down the like the also and of – and that we something to jump So that slows have enrollment, And are the like we a described takes difficulty

therapy to the have And that lot trials things we other cell we're expanding one these the we Now, is believe are U.S., opening in a like the of because doing, other complex of and ongoing. are we're and countries that countries less countries, gene trials. there other

that countries not patients So faster, other should so. Non-Hodgkin is believe U.S. we'll there the that multiple in is trial more because trials. potential but is see to potentially, expanding altogether countries opening which in we the recruiting also, is And accelerate UCARTXXxXX, Lymphoma the also

Arthur Stril

that think down lymphodepletion because CDXX others can with can compared anti-CDXX, the in for level dial tune which I which true this but dose, the to is you Matt, administration interesting knockout, the this of I approach And of a true could on also super or is what's you think, the definitely redosing be up single regimen.

opposed have us really really to to the dose allow ratio. benefit will have setting a dial potentially lymphodepletion a We the like we dial So to an single repeat that safety in and right on-off as fine-tune a [indiscernible] a exactly definitely

love and tunability. on, we inherent CDXX what approach, its spot you're So the this about I is think

Unidentified Analyst

much. very you Thank Great.

Operator

turn Andre back the the remarks. we to of have over session. end closing I call reached the now Choulika And for question-and-answer will

Andre Choulika

you company you very great questions. asking much question. all Thank for supporting And all the think for I of and like very they're

UCARTXXxXX. excited super of by course, start the Of we're

the to of is thing like very a also in keep you the that, we'll X you I definitely and these future. great moment. In day. all to with the near UCARTXX UCARTXXxXX updated thank product. manufactured X, company you the wish and is near X, trials would And on think a like interesting at future, in-house factor I on enhancement very progressing moving is are CSX we heading Also, and and PX

Operator

concludes may you today's for lines at Thank your and you conference, participation. time. this This disconnect your

Cellectis (CLLS) 5 Aug 222022 Q2 Earnings call transcript