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Cellectis (CLLS)

Participants
Arthur Stril Chief Business Officer
Andre Choulika Chief Executive Officer
Carrie Brownstein Chief Medical Officer
Bing Wang Chief Financial Officer
David Sourdive Executive Vice President, CMC and Manufacturing
Steve Doares Chief Regulatory and Compliance Officer
Yigal Nochomovitz Citigroup
Gena Wang Barclays Capital
David Windley Jefferies
Raju Prasad William Blair
Jack Allen Robert W. Baird
Hartaj Singh Oppenheimer & Co.
David Dai SMBC
Silvan Tuerkcan JMP Securities
Call transcript
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Operator

Good morning, everyone. And welcome to the Cellectis Fourth Quarter 2021 and Year-End Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. today's is that recorded. aware be conference being call Please first to Stril, I like the speaker, would now introduce Arthur Officer. Chief Business

You begin. may

Arthur Stril

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

for Joining our Dr. Executive Choulika, are prepared Yesterday Andre Dr. Officer; Medical Cellectis the and me Carrie Chief our the evening, Brownstein, Bing filed Financial and reporting call results its on Officer, annual its on December cellectis.com. ended Dr. with a remarks today Officer; and Chief press Chief at available our report quarter new Wang. release press fourth XX, report issued are our The year website and financial XXXX. release

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

Andre Choulika

today. productive Cellectis. everyone Good year Arthur. you, us thank you was a joining morning XXXX for Thank for and

become the are full relates made biopharmaceutical a we progress end-to-end to evolve to our We company. it and cell corporate therapy milestones as gene of as proud we've

of front plants with supply products' of that gives the on our control manufacturing our escalating us and candidate. line. We We completed have doses quality progressed clinical product and

We innovate. continue to

it working clinic product, first XXXX. have bring duel-targeted the to on to plan We in UCART been our UCARTXXxXX, and

It to through is to Cellectis T have been have partnered outside secure. plans, had resolved. future issues that platform TALEN financial Regulatory takes able core dual of paused of CAR is cell our cash issues Cellectis XXXX, none been business We clear our in some leverage that programs with early valuable to position the on therapy due technology. but allogeneic XXXX. these not Based our just field area. of are us And opportunities our TALEN our to term provide our

touch Medical on progress. First, I Brownstein, additional Chief Carrie will some details give will later. clinical of the Officer, our

preliminary BALLI-XX highest level regimen preconditioning right dose relapsed that refractory into of tolerated showed B in cancers. American running the different regimen or or expansion BALLI-XX lymphoblastic and promoted encouraging from the as At and provides our and was in December These alemtuzumab of X. fludarabine, at Society acute the we're forms our annual us activity and strong the sold UCARTXX XXXX, meeting efficacy in includes that we trials three results enrolling have refractory released Currently, confidence that moving with of patients in data B the we safety These received of dose our lymphodepletion alemtuzumab patients evaluating cyclophosphamide so leukemia. trial in of relapsed direction. UCARTXX held with lymphoblastic Hematology leukemia. well We are hematological patients patients cell the clinical trial, far,

the cancer to added another regimen AMELI-XX trial, also in We clinical alemtuzumab in leukemia. acute preconditioning blood myeloid

on AMELI-XX, ambitious ongoing product ability our patient our escalation BALLI-XX, multicenter trial new focused clinic, XXXX, the into in to three clinical program, dose recruitment we're – moving our So, and in development confident execute MELANI-XX. into

new for cash our We XXXX. candidate, roadmap, patients refractory also QX takes lymphoma. relapsed runway plan or with our into UCARTXXxXX, product to non-Hodgkin's this us new for file IND With a

the progress in end-to-end companies. made XXXX, processes. manufacturing one therapy now made the cell its Back and providing and in turn decision product gene cell Let's and with over internalize becoming XXXX. we the manufacturing. independence a have stronghold to the of In few gene candidate, meaningfully Cellectis towards the company Cellectis its therapeutics made therapy to of

that We been are has XXXX. thrilled goal to this achieved in say

produce sites our plasmid Our and recombinant our RNA, and produce Paris, we libraries, both our lentiviruses. operational. fully France North Raleigh, Carolina two DNA, own own type vectors, in manufacturing messenger are now AAVs cell two of We

our produce up T CAR to product. allogenic We are own clinical grade set

half clinical initiate and derisks already lymphoma. to very in commercial I supplies. reasons. supplies file candidates. the fact, the in-house in clinical exciting UCARTXXxXX becoming in of patients the This two self-sufficient new trial. plan its and clinical trial to Raleigh manufactured of least is dependence plan These positioned product are second candidate, market. In UCARTXX bumps lymphoma the dosing non-Hodgkin's is of BALLI-XX in This of suppliers. in XXXX, our non-Hodgkin's mentioned in a removes success on UCARTXXxXX, to We're on road. into This to an capitalize with IND outside reduces we product at a Cellectis our product for passed

candidate in T is validated The targets be enter First, developed designed CAR clinical manufactured Cellectis malignancy. in-house candidate also our first to It first cell duel-allogenic to has B potentially product product is hit in-house, and designed the in-house. UCARTXXxXX two trial. will

treated Allogene technology XXXX. reported of remains to beyond of important on X, targeting product a base source year, the Cellectis to our refractory removed that cell clinical the edited partner, and this enrolling multiple also myeloma. earlier the determined BCMA or and B Drug that CDXX UCART which TALEN that Allogene this was the Servier, ALLO-XXXA goes chromosomal single We clinical has which and has activities studies as Administration gene cells. pipeline began investigation, revenues. unrelated after relapsed the clear studies cell future resumed or clinical announced clinical of allogenic that, trials, in has Allogene of to Food power B it overcrowded on the clinical will and partnered targeting for hold on for validation metastatic on our resume carcinoma, January Allogene in want on ALLO-XXX patients CDXX. with old States United patient a candidate, activities products. addition, was ALLO-XXX, and it In its cells. In of believe announced now ALLO-XXX of month. announced edited detected editing it CDXX targeting all CDXX to about the it TALEN word that TALEN on Allogene's T announced activities their abnormality say real Allogene some was that October gene antigen product has resumed cells it's a gene I crowded advanced is UCARTXXxXX CAR renal alternative

the in T to is collaboration Annual or or pending initiate December in safe intent XXXX, American XXXX durable approved that mid-year therapy XXXX Servier of to to ALLO-XXXA support and and ALLO-XXX Society patients its refractory Allogene the on and X non-Hodgkin's on in Allogene trial the discussion. Phase FDA ALPHA lymphoma. alternatives cell large announced Meeting relapsed of refractory the reported data CAR autologous with lymphoma a B from with to clinical ALLO-XXXA promises continued pivotal track relapsed commence be results Hematology During ALPHAX to in

new of editing collaboration continued opportunity. and TALEN of front, Cytovia single-digit entered cash CAR satisfaction to sales by provide strategic Therapeutics. million with cells, company provides type joint include type of December XXst, development to condition TALEN In met. such and/or business agreement a with discussion with the The of NK be the conditions and the highlights up editing that the in utility and in $XX of February another of as either of new on expanded on TALEN selective development, system different to milestone XXXX, into the China to stake edited Therapeutics with cell gene products XXXX. modality research depending include T payments is in all totaling the CAR extension equity and $XXX Cytovia technology collaboration series Cellectis and us with gene in develop regulatory application. deadline Cytovia. target for XXXX, On product million by a net Cytovia and regarding partnerships for Iovance also expanded by partnered the In Biotherapeutics, we Cytovia IPS-NK development sales Financial for November royalty collaboration gene development entity, the certain Allogene choice CytoLynx that therapy cell Cytovia therapy signed, After have term of a payment venture to tumors. of commercialized we

top We committee general talent. team have management expanded also board and with our

committee executive background to highly with public who a like Chief Firstly, to leveraging cell company of co-founder companies clinical next clinical he financing our the team, and chief we corporate He and Officer. moment is appointed oncology global Welcome comes extensive to in Bing gene Refuge biology experience us biotechnology welcome Bing our trials. Cellectis. officer. Biotechnologies, biotechnology extensive Bing. would Cellectis stage of the to development recently therapy accomplished in new finance executive Bing was including synthetic the our will in companies finance. industry, enter our Financial stage Dr. take in from engineering, as this experience to executive where brings global Cellectis a and biotech be to Bing's Wang, I critical

[indiscernible] November observer Research clear an XXXX. company's themselves. medical place products that Head multiple board Bergstrom Dr. and of to at production candidate. brings of XX appointed stays of Therapeutics, as elements biology with serves precision director Donald Cellectis have on to industry the years Dr. prove the and the in already Secondly, medicine many the its Development experience Relay transform focused of in as of cellular opportunities needs clinical Cellectis as him the biopharmaceutical and in Bergstrom company. clinical plan of in We

to We we forward that in push have continue future. and future the to resources invested have in the

Carrie, to product would an turn the Medical preclinical clinical give to like trials Carrie I call Chief overview our Brownstein, over our please and Dr. ahead. go to sponsored three pipeline. of Officer, Now,

Carrie Brownstein

Andre. you, Thank

December persistence. deepen in XXrd making XXXX mentioned, refractory was would our cell lymphodepletion or after start data cell CAR with lymphoblastic to host expansion clinical with Hematology cyclophosphamide from Society to with like cyclophosphamide promoting Cellectis year T of UCARTXX, candidate productive Andre currently data fludarabine of relapsed patients American been to has leukemia. B received alemtuzumab. progress. allogeneic XXXX. lymphocyte added As in Annual thereby I TALEN acute and and patients our at off--shelf the of presented UCARTXX and for CDXX-directed sustain gene proprietary a UCARTXX who included preliminary with fludarabine, the and presentation We The programs the evaluated being Alemtuzumab edited substantial Meeting product suppression,

UCARTXX by syndrome. received cutoff tolerated. the treatment-emergent in the XX X dose lymphodepletion, of dose GVHD at neurotoxicity with which currently suppression UCARTXX is those was X% refractory dire in or X grade anti-leukemic Three syndrome cohort. No FCA XXXX, are supports of respectively, October alemtuzumab and to accompanied promising the donor severe of and with B-ALL, the Both clinical or was of with were who and Three tolerated, anti-leukemic and X enrolling patients, intermediate, nor transplant the was the of and need markers. alemtuzumab skin therapy. toxicity. and one level prior cell cyclophosphamide, have dose-limiting received experienced UCARTXX setting at These toxicities who options, mild-to-moderate and X, significant achieved patients adverse [indiscernible] activity and cyclophosphamide level patients Overall, alemtuzumab. As dose anti-leukemic fludarabine, without CDXX day observed at administered One at of dose by at less X one UCARTXX-related FCA after had host with and in lymphodepletion level UCARTXX further reactivation. reductions allogeneic fludarabine, patient of patients X reported fludarabine X.X% activity. experienced patients treatment BALLI-XX stem X inflammatory UCARTXX depletion. relapsed the level Encouraging promoted expansion, UCARTXX level additional date encouraging patients changes protocol-defined activity three development well cytokine events. treatment-related X release signs addition of intermediate. The data remain FCA in two UCARTXX, well effector patients cell-associated immune XX patients and particularly to patients dose in lymphocyte associated cyclophosphamide was failed demonstrated XX lymphodepletion X%, improved of after relevant which measurable unexpected than expansion for

serum MELANI-XX the trial move TALEN UCARTCSX, of Therapy first I'll in enrolled in being expansion persistence X the patients edited target on These was myeloma for dose gene currently American validate and CSX from Annual patients correlated Next patients enrolling and relapsed with Society multiple UCARTCSX relevant FC observed myeloma. T with cells Early with was in T a allogeneic or CAR as to as multiple and allogeneic product is CAR Cellectis activity. at our changes cytokines evaluated data data with the XXth cell refractory CSX-directed presented Meeting. preliminary and candidate in at Cell Gene anti-myeloma level lymphodepletion.

CDXXX-directed UCARTXXX, relapsed evaluated candidate, or be a T CAR patient being Lastly, breakthrough. TALEN severe myeloid major gene allogeneic T patients I successful population a cell candidate will need to product where product with CAR with our refractory addresses leukemia. This could trial cell a speak in unmet medical acute edited

it technology to forward when clinical the FCA available. that data are we Enrollment our programs, excited report to of plan We ongoing. currently current to becomes in trial Building at advantages. our this allogeneic with I'm enrolling CDXX-directed CDXX from our therapies. in therapeutic lymphodepletion. level platform I patients B is B program an IND has X candidate dual CDXX look cell dose dose on Targeting We validated sharing escalation malignancies are Phase of two CAR with to a well and cell half submit antigens represent both cell for the UCARTXXxXX, first second XXXX. important alternative product and lymphoma T targets in for non-Hodgkin's proprietary

increase the more has the CAR potential efficacy killing. to strengthening effective tumor of cells it the contact T Firstly, with cells by the for

for an Financial escape. population. overview that, I Preclinical the the Chief antigen provides Bing, ahead. trial moving hand it And therefore, and with our clinical UCARTXXxXX the excited like would Secondly, please over Officer, to of start very antigen to clinic NHL. of patients I'm to addressable and, Wang, relapsed/refractory With supports potential go to financials. call the Cellectis' overcome for breadth the may increases data it Bing lastly, targeting patient into increase

Bing Wang

a as from offset $XX activities, operating, And would brief like welcome. I This by financing of will everyone. proceeds the flows and cash was equity of expected $XXX stock year standalone net is a to was position I'm our good be at-the-market Carrie. here a position of the December to XXXX, cash, sales XXXX. focused excluding adjusted $X.XX $XXX XXXX or compared XXXX full as under shareholders everyone in by and subsidiary, $XX million our excluding into thank was in loss loss an million that compensation in This other April per pleased year or sufficient the quarter million revenues was least to full of This $XXX between net loss million be net Cellectis, million net was established increase compared partially or mainly million in our $XX increase Calyxt, full cash million core in the morning, Cellectis, increase you, fourth net Thank of used million provide expense the stock-based to investing loss and $XX $X.XX non-cash our $XXX full shareholders million I and in by million which fund and in per $XX were early share million, year cash we million company's raised The option extend of in This of cash highlight proceeds a XXXX partially of of on program to of to and by consolidated of share Calyxt, gain. loss to excluding financials reflects offset to loss and XXXX $X.XX primarily us to loss consolidated and cash attributable of to share million current $XX developing shareholders million exercises. of driven into to compared operations the are $XXX $XX our $XX spending decrease XXXX from per assets of the on Cellectis The of financial in cash for Calyxt, year net compared million per XXXX. Cellectis, In XXXX financial the warm share Calyxt for $X.XX December XXXX. in The programs. XX, to XXXX. XXXX. early restricted of of overview the difference attributable equivalents, a income in XXXX, XXXX. of allows or XX, XXXX. $XX Cellectis, Inc., attributable including excluding runway, expense, in operating $XX

Andre Choulika

and CAR us propels XXX relapsed in any in largest call, malignancies licensed Cellectis how than and close what's are disclosed product this how candidate and Thank reiterate allergenic or you, trials of administered technology been cell excited XXXX. have making most success profile, the like clinical the we the to gene set the Cellectis with XXXX with its More forward sponsored To partner, data a accomplished Bing. would technologies TALEN-edited has patients T in safety Cellectis built with robust, into on proud of refractory and promising editing world. by I

products diversity targets us and of our development, indications forefront of well as clinical allogenic next Our developing generation positions and therapeutics in ushers the the platform, that at UCART with of the therapy. CAR cancer novel as T

momentum the promising editing And leverage that, our a scientific and and genetic paradigm to of to cancers like technologies, capabilities for open call candidates, With will us and our to hard-to-treat positioning the field. in-house with for us would forefront this at medical I in manufacturing expertise shift rare the beyond. cancer believe and patients lead to Q&A. to At of that Cellectis, patients our continue we strongly clinical diseases. with in forward transform look lives we XXXX development accelerating We this product and our gene

Operator

Instructions]. [Operator

Nochomovitz comes Citibank. question first from Yigal with Our

Yigal Nochomovitz

Could the an the about bit need second the in moving you're on little just talk the a to the FDA of the and will product comparability amendment to in-house IND product the half UCARTXX, the those with start in-house comparability presumably off version? year. you from whether has between two studies products, you On signed CRO the

Arthur Stril

is This David, this Arthur. take to want or one? you Andre

David Sourdive

compare we already one far that we've so conversation the using we of was the the CMO, as how the made made with will out the started that one for been originally So, and Raleigh CELLforCURE. have product, agency in PX

an very the is an of we're to swiftly. ongoing come conversation. this definition to that And confident appropriate means So, do we'll

Yigal Nochomovitz

working of on, datasets data more you on Regarding XXXX? you're see give we might those the three which for are point, in Phase I at this able granularity any that to

Arthur Stril

We're as will announced for specific have – safe to definitely sharing at the year. – we what on a would one in to want on this data set trials. datasets meaningful escalation of We're through the process, Carrie to UCARTXX is one these provide data how program we at as depending a various we conference of get to prior as these set clinical programs data giving of definitely an on data course – is say Arthur year. last to the matures the the more, done by in not particular committing not is meaningful go if that the year, in at least over update of ASH But course a

Yigal Nochomovitz

what you you Obviously, be all question. XXXX? a CD talk very, might XXxXX very CARs is the interesting about product. beyond last And Can contemplating other combo at

Andre Choulika

if answering Actually, the answer. wants someone is to question. No. This Andre

criticizing of these have interesting people the it's already because They're have been the product is commercial I targets, that develop as XX for as strategy even very products. This XXxXX. interesting go or going we don't that products have not don't these fact a a the or such on positioning that face, – unvalidated, they're to commercialize not to XX have payoff. XX, competition I we BCMA example, a great type we into such us But on Probably we that different this are positioning consider competition think today, have is and and BCMA. Cellectis is CSX angle. XXX, in targets So, listen, we're to think if unvalidated very

think disclose. so going all we're product not We'd is to to is wise next competition, in your that this the attention on these develop going releases something our have on disclosing our and concerning as development year, very like would believe to the type good I to of going XXXX and be to data side tip probably because place So, happen of that we we're had this far. a products Arthur we're said, the

numbers disclosing the So, But of target excites this of going for the first, also happen lots targets, for but a is to future that that believe is dual interesting very us. thing tumor in general. for we potentially reasons, what's safety performance killing would formation to the and enhancing products [indiscernible] associated something in crucial of and is of that for the a also these be products have of antigen and the these better potentially the increase approach density

Operator

is with question from next Our Gena Wang Barclays.

Gena Wang

two. I have

is UCARTXX is one the to need in-house in-house order to steps manufacturing. regarding second Can first UCARTXXxXX. start complete you in My out The regarding product? you lay question dosing

any wondering thoughts the updated Just on based initial UCARTXX on doses data?

Arthur Stril

think I Steve for second and the for may question first Carrie. question the be

Steve Doares

we've This already produced in-house analytical in is Raleigh, been Raleigh, the as Steve. here for an terms The materials clinical preparations as is testing ongoing, amendment. In and have well UCARTXX IND so. of done in produced

on the in So we're material the half of second track year. be well using that to

Carrie Brownstein

doses question the Sorry, second XXxXX? what's the again for with

Gena Wang

on updated Any That's initial correct. doses? thoughts

Carrie Brownstein

provide on design start from to going it's a we that T dose patient it's help internal where space cells given data but our to to is have and will the of trial starting details well hopefully, both of CAR very Yeah, support a expedite clinicaltrials.gov, potentially And you'll lot help in start. in going be could and we see, support understood the where trial. data population trial NHL, terms of to have help we external what with lots the clinical like. not data I'm we and When look and

Operator

is next from Jefferies. question with Our Kelly Shi

David Windley

at for on on T Jeffries. is Dave My XXxXX. is Shi first CAR This question Kelly

thinking wondering, are trial you and of clinical Just relapsed in design, enrolling both your patients? CDXX naïve

Carrie Brownstein

that. take can I

how based decisions And or would helps would on see, one expedite in we expedite a enrolling population start because broad trials. about thinking we then, things what on more forward that subsets. make we're clinical always specific patient moving So, we to

David Windley

is program. of any expect update Another this year? one your during tumor solid Do we on the course

Arthur Stril

is I Arthur. can This start.

we've is basically, So, a announced what focus… is here

Andre Choulika

it's Actually, question. good a

As we think developing most these of of mature shareholders the conditions power the the before market patients fights. excited, our that And huge excited is product them that of these have. we our all of XXxXX, but these candidate But put can strategy scientific trying we some have, We're all potential. the trials we into of therapy we're company interest space the product the type there for currently evolves as we and pressure push clinical products and and as of hyperfocus today get pivotal and choose R&D fact still that and development, international it, situation our the with the I reconsider we'll evolves, of is selling given shelf. extremely course, of conferences to the into to have products solid Very, company on on to can these and will it's development that certain very market tumor hem-onc expansion, IND situation into – products rapidly market probably the the And hard the pushing our that that how and considering. the announced we pressure the three the start trial we by be have. are And that see and, that the clinical in conditions for global gene to company have external we think the that products product we trial. in

Operator

Raju next from Our is with question William Blair. Prasad

Raju Prasad

that question to do? CDXX run having engraftment. of Is show I to with you discussion impact Have have on you just conditioning agency run? had conditioning quick the trials I the a know trial to CDXX any has on regimen. to anticipate may something the any that a on you had Allogene

Carrie Brownstein

could start. anyone wants Sorry, in. to chime else If I

think – okay. I oh, that

Paris folks can got disconnected. I Sorry, looks it take like the this. in

our to little filings. So, here different But, not we own it's a a which proprietary ever the to for using Allogene a may is a do that's anywhere. going is may antibody, BLA need I'm authorization is anti-CDXX remember, not had what program or different. marketing which product speculate not ALLO-XXX, bit their

antibody. little our different see already have as need. trials using with we're we'd of a a it's right the without and with And continue dosing I at, that them, alemtuzumab what bit discussions we So, in move as would not these to in move to find development we'd think data we're expansion discuss I unethical it – as the we're showed it. it, without we there's to forward personally, be we've we that support strong we December, our doing And But, at persistent plans. think development, ASH and that with what But of situation. now there's looked would forward and seeing but obviously, would without something I all have is with

Raju Prasad

of with forward? decision some making there decisions data how now in year be following to you at the thinking or point, point product, year? get forward? move you products move as the Or would from of kind trial and pivotal how kind next maybe of XX on Are product concert are kind XXxXX curious, you a about planning right Just to both

Carrie Brownstein

think separate But, medical likely as unmet talking it would a I about and those need in ALL, patient we're conversations that given discussions population we think obviously, with XXxXX, has we a with niche we interesting potentially really right ALL, this as NHL, is just would we programs. product. that's have forward that moving and both again, in, are continue given to high forward for forward move move but UCARTXX example, because, what Yeah, also have as for it we're now, question but not be it could I working

Operator

Baird. next Our Jack question is from with Allen

Jack Allen

CSX I the on provide more clinical side the quick was hoping have first, with color your guess, on of progress a ones that candidate. things, I two bit here. you I

And X, like color in I'm you've maybe in I around you provide Sounds maybe of but and, cohort timing potential can X. coming we dose moved then, on plans payments and to the was that could see bit side, any you the curious just many that dose to hoping how the level patients your as year. totality little guess, out a dosed to around X milestone it I level you've dose level in the of move on lay financial could

I to middle do think in into of have just that the pivotal a clinic. And study then, initiate ambition next year. moved the ALLO-XXX they

So, comments as color milestone well, the other Cytovia. any those hear And on any I'd Iovance milestone payments. collaborators love from then, payments and to on

Carrie Brownstein

about Carrie start I CSX It's questions the could program. here. the with

that dose going getting the with to So we're we data. going patients moving we're to to UCARTCSX we of many sets level have speak in on when ahead X. and in are next program myeloma. I'm the into plan disclosed And not how

suffice it have to say extremely medical needs. think still high excited there's I we unmet investigators,

did and know, a long there's you come FDA. As hold clinical off disclosed previously that periods we by had between some were things patients in waiting and we that required

hope through sharing, we're reasonable probably and as for set And and we a provide expeditiously data and on to so, I would pivot quickly, point a questions. for quickly moving starting have worth it we disclosure sort. and be we safely add for expansion to the it and set can more financial when as some data a an Arthur now in like will potentially when move pass Bing And to of external

Arthur Stril

of on basically, mid this initiation guided the the had of so for Jack, all, trial, the size first And again, payment this partnerships, haven't be definitely stake we're the the payments, definitely $XXX to into pivotal milestone one. amendments, be with payment, for to Iovance terms million recent equity will there milestone which the is collaboration a up $XX million for And Allogene the haven't collaboration. eligible of Cytovia, To year. an of milestone upon But of also stock. disclosed for we but on Cytovia getting milestones. going the we the we're the other Allogene disclosed of Servier, either CDXX,

economics. will And Cytovia coming seeing progresses so, as months, some in these we the that, expect products start we

Operator

Our is next Company. Hartaj with from question Oppenheimer Singh &

Hartaj Singh

questions. Two

manufacturing. on Just a the quick question

of on trials clinical – Raleigh BLA, you the secondly, the then, highlighted you go get XXX you And the you manufacturing Raleigh might manufacturing Just be and IND going clinical get can do would Will point hopefully sort that, if enroll vein, to sort you to – assuming in back CSX side were at facility? file a might set had same and have this from you I materials XX an of you the set for that to to to do manufacturing have convert future from of after and ready will think facility. doing the facilities, BLA that you that through using as Raleigh there then previously potential to IND? have R&D you

Arthur Stril

one? want to you take Steve, this

Steve Doares

from produced to manufacturing. an to being in going it's major from UCARTXX of that's a internal location, you be existing to IND one CDMO, amendment change Raleigh, terms manufacturing namely because a the considered move In when the

amendment So amendment. dependent of we IND is where and they hopeful progress on course, yes, submitting to be some we the an manufacturing this future But an well BLA a how moment, Raleigh at upon the are a as IND the point there XX are state the site. at in very will on would to enroll And progress. as trials BLA. focus clinical But, for

Hartaj Singh

XXX, would them ever producing moving those, facility? CSX you on and just consider in the then, And Raleigh

Andre Choulika

to Yes, we're course. this, of planning do

Hartaj Singh

Just last question…

Andre Choulika

They both line, them. of are next in

Hartaj Singh

in bispecifics, you any might with dual-targeting sort but the Ts Ts which the along some sort more being your kind of then be as CAR the or moving do CAR see kind people future CARs, do so bit that'd CAR you bridge a T. generation those a it more – second thoughts current going others against believe with of to XXxXX there. just little [indiscernible], against and further a up see dual with of approach competitive CAR Ts, And be and of

Carrie Brownstein

I'm it. take to From perspective, a development happy

where and a of again, end to lot that, data. products going you the were the on market programs these is up positioning these dependent going think to be I in space

It when easy extremely they're the you of CAR treatment what's the clinical think allogeneic T given to space paradigm fact between changes autologous if to the space. about that I know in for wait the T CAR important ready, current versus entire their word, we're that in for they're autologous right need the manufacturing don't the is freezer, is patients. accessibility, don't the but, versus talking I recognize again, cells competition

if centers to even or going XX say, I matter. enough, I data which as as been of after, – and has as strong let's provided while think let's more line be, you will don't data autologous of need and, an we something, great or the and, that's specialized and, but So, don't think strong, as been not and, the a I strong space second are bispecifics, isn't think these it kind say the a that it's has said, I autologous as think

of how to can is give to fact key from really patients. the of so get on to set the who are it their quickly think up it from I be treatment standard change hands patients and all treating huge physicians care players purposes, speak, that is going and the paradigm

it getting product their cells who the a CAR all and think, data when think these you as have it'll come would data, or patients our be maybe Ts denominators depend to to remember, who've But is they comparing, again, more data. possible going based therapies the then the autologous the it's If helpful they And strong, I looking on had the patients that at almost you only then, the remember, out been positioning also of prior out-of-spec failure bispecifics for against an when progressed on of to treated. are and as all and look to we're throw compare actually So, manufacturing aren't received on was strong because, as after. I obviously, at data. approved, versus data it have patient the based labels or the either

it's redo much rates you everything, lot label. if and what's just much, a so, PFS the those actually And numbers, than in lower of and much, the response

be And we T that's better well. CAR careful comparing. as much bispecifics so, And cell those to so we're the than when need extremely look therapies part of reason

So, yeah.

position, could I exciting. clearly any we so makes this So, what think which is be in

Hartaj Singh

the side. on manufacturing and Thanks the the chopping wood you're that updates for all

Operator

Instructions]. [Operator

David is next Dai from Our question with SMBC.

David Dai

additional Congrats manufacturing process? CAR T you with also XXX. know on the changes T on the is new new manufacturing construct, progress. I and the have a CAR some color We that the XXX question share updated process. your your on constructs product an just Could on

David Sourdive

This David. is

adaptation, did allows that knockout major have disclosed. evolve what we UCARTXXX to a and And was So constructs. incorporate including change alemtuzumab CDXX that molecular to this we explore in which the is us terms of

we taking a it's evolved far. are the UCARTCSX. that much, the In into basically think account working robust product. more we itself, a And much also with so producing and better we all process UCARTXX and from much had gained nutshell, We teachings reproducible

this So, of I evolution, can but won't at the elements into those the get details we share the are stage. process that

David Dai

the if additional you as programs, on could vivo quick update follow-up, Just provide the on some in for of those maybe filings IND potential some just color in share a vivo timing programs?

Andre Choulika

huge believe and currently, that sure in fact what programs the traction, to the vivo in going product. that the you're we the of UCARTXXxXX But assets focus reiterate the we are roadmap plans have, saying I'm mature not current have we're a have because we that, we about this in our UCARTCSX space. have and four and definitely on exciting I'm putting UCARTXXX, UCARTXX, XXX% situation

that pedal perfecting And market approaches these also TALEN-based the because base finessing at these But developed four because essentially polishing has are we the using interested is the that. cetera, applications very vivo situation is current today, we'll also high have potentially excited all it's When metal the a programs. editors situation of different in TALEN the vivo current the And on in of conditions, in TALEN in all the that two improve, a or and between we're and activity these for cetera, trials. split editing course, and of a the programs. will of the We of fantastic types about accuracy. put today, company on excited technology resume, on focus extremely on et and et they're R&D stage arms

Operator

is final Silvan with Our from question Securities. Tuerkcan JMP

Silvan Tuerkcan

had level of in can know are this. you're Could questions. UCARTXXX, on terms give just at looking if that two color on I dose I was don't that you X. us enroll on believe the you dosing comment last where you some in program? I on to comment quick But just

Carrie Brownstein

This a reasonable of level disclosing we'll move is not we've continue where sharing on been and X, patients goes starting and can Carrie. Other terms as in that, we'll this filling are on. when data to dose than of exactly have be that. the at I we're next stage, to for working the are we're speak dose Again, levels. to set we year, and out And which data. that of number we forward cohort share beginning time ready we

Silvan Tuerkcan

the cut I an premature? you be And facility in this is And this on some UCARTXX, think going data Raleigh that's to additional there chance the material do there have any could of was think that the that year. new data? from Or

Carrie Brownstein

spoke we'd sharing haven't As earlier we exactly which disclosed to Arthur in this dataset be actually year. per the call, se

at we or share not did programs, the of not. on one data will being XX it to speak specifically We but least

programs, move not support stage we drabs meaningful over the time that's fill us a be I there's datasets to of all data it's with cohort. said I've and the and to As set giving the just the think share/disclose that next when really important we giving because dribs

to So, that's do. not I that something want

at out figuring we and the be where which make the will based we time. sense So, on is most what meaningfulness of the set will are the

Operator

our We I have management call closing of like session. back comments. the turn to over reached would the end for question-and-answer to

Andre Choulika

also, very thing a XXXX. Well, to very pushing for Cellectis been all for the we've Cellectis. because it's much. call future. in thank company, productive different from A you huge Z. We're for three for this now change one is and is year this earnings We're convertible for you producing trials. that our a own product excited the commercial And IMP which year. transformative our the excited. on convertible thank is this XXXX, by pivotal clinical our And We're attendees producing And company extremely in a And to to was

I phase passing Cellectis a into of that, much interesting step, history the hope cannot coming unstoppable. entering We're you CMOS. exciting clinical wish in very more in future. difficulties you and certain had the our with of I for all have. how sharing know trials. is You and that very the interesting company, into a to type at in day. But a produced different excited that And and the the I XXXX, Cellectis what's thank you that products we all were be about today, past going we With And this on will data great company be like year. would this it's

Operator

conference. today's you. does Thank conclude This

disconnect this lines your your You and may for thank time at participation. you