GMDA - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell’s Conference Call for the Full Year Financial 2020 Results. My name is Brandi, and I’ll be your operator for today’s call. Please be advised that this call is being recorded at Gamida Cell’s request.

Now, I would like to introduce your host for today’s conference, Mr. Officer. Business Chief Hamermesh, Josh Please go ahead.

Josh Hamermesh

financial and Thank our is this today’s the morning, website everyone. full financial our to our we which issued release and morning, during you, Company of which summarizing Earlier review on results Brandi, Company, call, update we Welcome an progress available the the press good on will XXXX. for www.gamida-cell.com. results a at and year provide across

Chief our remarks. Financial Lodie, Here Chief Ronit today of our call Executive with also call Adams, and Chief Officer; and our our Chief Julian Lankry, Chief on are portion Officer, Officer. the following on Officer; Medical Tracey me Scientific Commercial Officer; and Simantov, for are hand Q&A Korfin, prepared Chief Operating Shai Officer Michele the

strategies, During product may we and potential including clinical our forward-looking the our and about candidates, of and operational projected plans, statements therapeutic this call, objectives, and operating commercial expenses and development cash our runway. future expectations make plans

results other makes actual of to future, what including otherwise. we factors, These events as the important in materially caution may future Gamida that and of considerations from the due described of number XX-F today, in our Form a Risk update you not the information, forward-looking Factors SEC a our the and with result project section filings Cell new or that to whether today from differ views time Our time. in them we represent of statements only as we may

the turn call to to over like I’d Julian. Now,

Julian Adams

patients therapy of care At for at everyone an of opportunity this patients potentially to thanks our across therapy. innate are us with as first Gamida therapies harnessing review XXXX become Phase The omidubicel time blood both and ready primary made plans who setting, pending review. standard white Starting to trial important neutrophil the launched in versus the but time omidubicel needed In commercial cells it engraftment, donor. our malignancies, progress made could we’ll developing which our X FDA completed XXXX, natural This create including global and us in approval. is X poised Josh. forefront demonstrating have omidubicel This And for around omidubicel, for with summarize marrow to for proprietary important provides bone to cell patients our Phase progress cell lead suitable clinical we year GDA-XXX, omidubicel by and that primary or significant entire and transplantation. we transplantation. was hematologic to we an advances upon of Cell, approved bring medicines marrow not a NAM pivotal data pipeline, to a was expansion commercializing evaluated NK Today, the secondary endpoints, with patients reported for took platform bone morning. Thank to to diseases. has randomized study you, standards the cell the curative transplant, the be Cell match following cell redefine the recover program, its study. including life-threatening blood Gamida joining cord FDA or a technology. with endpoint programs did And benefit killer for FDA an

omidubicel have commercial very manufacturing Following a B requirements. with clear of we our Type understanding now December FDA, meeting the

by requirements XXXX full needs. are supply submit end to fulfill commercial BLA meet the and the these to We track on of the

patient patient a prepare a a and the As a U.S., of access malignancies support the approximately for and potential their XXX focus over of on individual step transplant program Gamida support hematologic annually transplant to plan for become center organization, with positive we With in eligible including process. every capabilities, are to creation to each experience. XX,XXX establishing commercial we of centers commercial omidubicel transplant caregivers Assist and continue key to launch the and advance and designed patients at Cell we

we been for opportunity omidubicel from indicating physicians by feedback I’ve research, encouraged In safety addition, and efficacy payers conducted and the market to have and extensive the improve outcomes.

for Following FDA market have do appropriate an the match. currently cell be supports all has able opportunity not that cell for omidubicel a match patients approval, will the to of are also stem transplant, Omidubicel patients an increase an donor. who important in need to related find research to not therapy allogeneic who access access

first killer includes progress the the hold to cell-based preserving functionality. treating significant Moving are NK of promise in ability Natural GDA-XXX, in tremendous product immune pleased our NK report challenge field to that expand for innate while to cancer. their culture for cells cells our rest the candidate. also A pipeline, we’re cells

a X technology safety monoclonal study, the assess direct multiple non-Hodgkin data cytotoxicity very Our cellular in which antibody to as study of being ongoing tolerated antibody-dependent killing patients in this designed NAM well challenge early demonstrated based addresses Phase known our potentially was multiple X advanced from striking of improves myeloma. responses, with in GDA-XXX combination efficacy The and lymphoma. while and their lymphoma, with potential has has signs in demonstrated proof-of-concept tumor with Phase GDA-XXX or our durable impressive ADCC. complete

significantly cell cryopreserved vision GDA-XXX, function a we and off-the-shelf launch favorable by past my we position year. proceeds omidubicel provide year further the omidubicel and the as cures NK potential product tumors. allogeneic details and patients. want we mid-XXXX. responses candidates by of a team $XXX acknowledging gene both Chief past the developed with therapy a hematologic enhanced the have provide of resilience to solid Based edited clinical approximately over million profile. These and durable in approval now navigated financial raising by now we support bring of platform to impressive the through formulation challenges our malignancies expansion deep in support on to our develop NAM the on of of leveraging COVID-XX both Officer, omidubicel to programs pipeline the cell generated strengthened our are to a with and safety multicenter work sufficient have for introductory and the data We I Simantov, and through GDA-XXX. pandemic support to as and capital Ronit? I’ll both Ronit will Medical product turn to call development the Gamida by Cell the conclude dedication remarks the Furthermore,

Ronit Simantov

in These highlight report study pleased time time the October, there randomized, X everyone. setting that for meeting well study, reported outcomes, Bone the be pre-specified intent-to-treat of weeks presidential In GDA-XXX. at of XXXX, well secondary May ago. in well we X was basis. the presentation next morning, were XX omidubicel. baseline and endpoint with omidubicel outcomes a engraftment. transplant. Julian, primary the omidubicel as of designed blood. on review demonstrated encore data annual need study and allogeneic engraftment, neutrophil The endpoints I’ll Demographics and our were supported population And engraftment programs a the the and were the you, met the positive throughout three morning, clinical arm, XXXX characteristics standard Phase presented and Clinical at an on an trial analysis. patients hematologic will Thank marrow In study and and met of TCT week. primary disease patients meeting and diverse exploratory conducted European neutrophil both Marrow rigorously balanced superior reflected for This with few session good its start all to infections platelet malignancies to peer Phase we were we study bone hospitalizations. cord analyzed additional Transplant as the presented XXX first also in the reviewed XX endpoints, a I’ll with endpoint

and infections also fewer spent first after than the to serious less bacterial, days Specifically, omidubicel comparative in significantly Patients viral the transplant. patients XXX hospital fungal randomized had time in group.

acute And tolerated. versus in chronic in was blood two modalities, to was graft omidubicel has Importantly, transplanted which statistically and the patients both similar generally than in the other cord arms. of be shown incidence disease, been lower in host with particular, well

we for and relapse for randomized detect of the non-relapse transplant-related overall randomized or was mortality was omidubicel difference endpoints, to patients including study the to XX% analyses, not or While patients which mortality, results and designed comparator, survival, XX% in I our to want reported a omidubicel. XX% XXXX The strengthen control. for we the to presented the potential data thank clinical study. in XX% continued in patients and of was participated the to omidubicel and in arm our which that investigators, confidence in caregivers these

for as forward. We move their are grateful the we field support

patients in and generally study haploidentical anticipate also that cell conditioning presented standalone hematologic the led graft. eight diseases X/X XX the on submitting investigating five three occurred patients from engraftment. platelet life-threatening treat omidubicel we severe omidubicel following With respectively. were disorder, year. seven Society a malignancies for a this the XX sustained aplastic and transfusion. XX fourth with rapid of potential a BLA omidubicel National cells, median with recent that patients plus in Dr. omidubicel and engraftment was of patients, omidubicel We quarter the early being by beyond Neutrophil Childs these had currently at At rare with of data to the investigator stem dependent underwent no eight total showed in patients Phase follow-up received believe months, intensity who days, to of as well-tolerated at of data the Richard With are has stem and and who omidubicel reduced blood data Institutes Hematology of transplant transplantation longer an and led in The and Conference, we of with Health. days recovery median sponsored American hand, a anemia,

high still We cord by blood who conventional are This at failure data transplant. patients study in for risk is with these graft encouraged ongoing. are

mentioned, first therapy, addition NK Julian cell advancing are in As omidubicel, our GDA-XXX. we to

data lymphoma, the median also responses B-cell had rate overall promising activity complete were clinical heavily in a pre-treated at no GvHD with large observed for of patients demonstrated histologies. lines three were in were observed. is lymphoma with with safety a Phase in the is assess antibody impressive of patients non-Hodgkin our with study, lymphoma dose multiple proof-of-concept relapse patients was myeloma. or we limiting We being monoclonal generally XX study the at Bachanova the XX partial complete of GDA-XXX the patients XX%. Responses from with impressed University These GDA-XXX of rate doses all toxicity, conducted response The designed no chemotherapy. have with and had a We and X response XX% with lymphoma. patients follicular prior with and or which to XX and X patients non-Hodgkin Dr. an safety Of diffuse in patients by response combination refractory with At with disease, Veronika myeloma. Minnesota. and XX ASH, no very well-tolerated of of neurotoxicity presented with XX evaluated importantly, in

a therapy cryopreserved Shai cell to call potential over financial advancing developing submitting with this review I’m of will We’re be multi-dose patients GDA-XXX the as the the our off-the-shelf allow proud in This our IND second results. turn global to and conduct now pandemic. the in of lymphoma. to a us half their year. I’ll our study formulation and will multicenter, during clinical study dedication very team of our to to explore

Shai Lankry

everyone. good I Thank full financial results of morning, summarize Today, you, year our the for XXXX. Ronit, will and

as As cash equivalents of $XX.X million, XX, XXXX. million and December total we compared XX, of XXXX, of cash had December to $XXX.X

December were able and during public million enhance with our of capital mentioned, gross our from proceeds significantly we $XXX position XXXX, offerings. Julian in total May raising As to

grant organization. million, program, we clinical announced within to and $XX.X February as for Phase expenses addition addition, approval year to to due to Israeli finance by net million commercial income, way last million, The administrative headcount a includes compared GDA-XXX were royalty-bearing expenses. of to net, Finance of expenses $X.X and $XX.X Capital omidubicel which were financing General million The expenses, due well million million $XX.X trials, of our for expenses increased related Those year. were BLA of with launch the the to million $X.X warrants insurance, in team. Authority increase readiness Research the activities concluding increase non-cash Management. XXXX. resulting net, compared R&D compensation compared for million last The was services cash of and In in compared as run of was non-cash to increase activities, for development the offset XXXX for travel, year. $XX.X our XXXX. including loss to XXXX, The primarily and to in extend million in the Commercial from the legal advancing $XX was million by a expenses liability. compared million professional X leadership expenses, mainly expected $X.X and Net increase additional our $X.X year our revaluation clinical mainly the $XX.X $XX.X Innovation mid-XXXX. potential shareholders, by the revaluation attributed decrease loss beyond attributed Highbridge a transactions financing $XX.X to to in XXXX. in $XX.X owned were million expenses, million, XXXX, year, were omidubicel mainly was

Julian. will or to ongoing activities that the this will excludes development into half used funding expect operational This for $XXX support activities cash current runway business year. current operating undertaken. may of that turn cash million. any be our from I $XXX our our cash based our plans and We activities We range million on back position anticipate year may guidance second call be the is that over next operating ongoing additional to total received that will With

Julian Adams

Thanks, Shai.

dedicated could disorders. patients for with omidubicel, expect GDA-XXX, and to our data hematologic about blood initiate excited this time opportunities are are the quarter lymphoma being of which submit we committed X the are Gamida the launch-ready And Cell trial, compelling transition and ahead. to we registrational if approval. With BLA to at year are in fourth clinical data of With very in to finding the Phase sponsored a we’re the with consistent planning malignancies cures We the into results. have and study,

a to expect you Gamida And year. XXXX on So, progress be transformational updating you Cell. forward our can as see, the look for we throughout year we to

open Now, questions. we the will call Brandi? for

Operator

question Tenthoff with first of from [Operator Sandler. Piper Your the Instructions] comes line Ted

Ted Tenthoff

Great. us Thank Julian, preparing BLA done the omidubicel? and for you walk prepare Thank congrats but to the as submission, on through of respect what’s with build-up very much, in just concurrently progress. all terms you commercial also being maybe sort you. both for can you of

Julian Adams

Okay.

is me And Let submission. the of CMC BLA quarter, The modules necessary the the ready. module module be lastly, begin submission. for be be the are for will near-term. the module BLA non-clinical clinical by fourth in will the that will which with being completed completed prepared and all complete And

to about our turn to preparations. me it talk over Let Michele commercial

Michele Korfin

In Excellent. Thank key there’s you, commercial, Julian. to Ted. And good three really on. morning, we’re aspects regards focused been

outstanding a cell with remarks. Manghani, leading therapy; is was first Account Shai and in Management, the brought The leaders and team, in hematology on of and prepared leaders, We alluded other our Linda in commercial this to experience Rocio on already recently some Stamler, established Access they to great his couple and joined Market brought lead Marketing leaders.

opportunity So, a very will support that was great execute key transplant And to cell strategy on matched very stem exciting the the approval area need allogeneic part. do a next clear omidubicel commercial done approval, the have appropriate the needs leadership have option who an on team place. market upon FDA we It’s are upon finalize what great very important really FDA The in fact donor. be be in patients access insights of who we a have market strategy. that omidubicel, therapy who to now for third to that terms to related not that’s an and for

and the So, remarks. is around we’ve to making Cell commercial is manufacturing experience for we making patients have in transplant his finally, educate sure educate readiness. encompassing sure launch plans Gamida making sure focused payers, we Julian the sure system the alluded on through transplant and this prepared strong that support to got our for aspects, centers, the doing we’re that making leading we thought we’re third Assist, the Really everything key our that underway. four positive a readiness all centers,

our nicely in Kiryat moving very along new Gat. We’re facility and Israel with

their We’re partnering readiness with also the Lonza for for BLA.

FDA So, we’re omidubicel approval. to looking upon forward introduce opportunity very to the much to patients

Operator

Your of line ISI. next with comes question Jonathan Evercore the from Miller

Jonathan Miller

hire the folks you’ve prep. GDA-XXX. How ramp as spend plan? about for that a throughout a I’ll XQ, do to you’ve up got need achieve guys. commercial taking I your on I’d got a big love in ask team some commercial Then now. to Thanks how and question. will ramping secondly, And Hi, place follow you year sales question. Obviously, bit understand time you about to my strategy you the think in little just BLA

of of maintain to that product do How a One these cells later adding is about profile healthy factors expansion balancing, NK cell NAM. pipeline, you’re biological interesting and editing product there? additional maintain the profiling think naturalistic you now, a But is if -- gene introducing additional engineering the about in this with in functionality, while the that products. introducing you’re

Julian Adams

Michele, you, the I address NK And thank And the So address questions. please first will question. Jonathan.

Michele Korfin

Yes, Good absolutely. morning. Thank you, Jonathan.

to will for The us and regards standpoint is in personnel the ramp-up be good is field a and launch spending. key the also this very the in So, success. the obviously, efficient personnel our lead through news to personnel, from of

at look with centers U.S. centers you XXX the clinical know then, XX so centers, had about trials. And these XX% in the also many centers. We certainly during know that the accredited centers least transplant team with quite direct FACT transplants let’s so. the when up the her the and at roughly know So, And There’s in transplant we make Ronit U.S. start target, experience well. of XX of we more

efficient and terms targeted launch field force. very a anticipate we So, in of

main terms obviously will with In personnel fall groups. numbers, categories supporting actual field into of so three our

account be side, The first team. will the management on the commercial

focused launches because that’s the would payers be Manghani relatively Rocio XX that looking space the on effectively relatively at to cell patient footprint and the look therapy you’re also benchmarks that led U.S., individuals small probably We’ll you a are launch have positive needed therapy If U.S. consolidated. private also to in personnel other the by of XX have experience. payer at

initiatives then, the group both there. Ronit’s affairs liaisons payers. medical and centers XX And the science supporting that So, are who colleagues personnel transplant have probably an we’ll educational led about are medical outstanding the by with

So, again, standpoint. therapy, forward. we based will very have it a a you. clear to And from turn headcount efficient spending be a and going Julian, cell it on our path experience I’ll launch back

Julian Adams

the cells. to NK Turning

So, about combination NK solid therapy let non-engineered consider for tumors. is And with the we engineering to product cell rituximab as a Tracey GDA-XXX for in talk particularly our candidate me expanded our cells, plans invite lymphoma. addressing first

Tracey Lodie

Jonathan. NK our on And the ourselves up of Julian question, we’re expanding that as NK receptor Julian. for we potential and first important nicotinamide. such well you, And are said, with to lymphoid still, regard our cells very And cells maintain surface, to your the for causes Thank receptors T-malignancies which part, home cell Sure. thanks to we into unique as as have this, believe with because ADCC. organs, and CDXXL, CDXX as uniquely in

with co-stimulatory receptors effort So, what research expand just as the NAM, these additional the we that maintain the receptors, upon will those to active we suppresses potentially the editing efforts by this persistent cells off we editing and but of negative in make see negative allow to think engineered properties ourselves to make and survive further more products. in microenvironment tumor microenvironment function this will will cells and and some year enhance tumor lab

to back I’ll it So, turn Julian.

Julian Adams

Jonathan? Have your we adequately answered question,

Jonathan Miller

that... to I develops now, how look those for that behave. exactly And program seeing forward I indeed, think Well, and how

Julian Adams

Yes.

named yet. specific haven’t We targets

Tracey’s appropriate time we’re the in right But, ongoing very encouraged under what at now supervision. so will is future. about we’re do the seeing. And an the We research

Operator

of next JMP question the your Butler from line Securities. And comes Jason

Roy Buchanan

for for taking It’s on questions. Jason. Roy Hi. our Thanks

for treated from prepared guys missed many if can XXX? different the remarks. And week next I access? meeting the in that Then, you But, can had if on patients follow-up can the Sorry TCT been anything EBMT just how omidubicel, expanded have these in the meeting? I disclose Thanks. wondering a then, we that’s expect at

Julian Adams

this is Ronit, for you.

Ronit Simantov

Thanks.

we’re TI a So, being will also European investigators, in be be on opportunity with the forum. later There in the panel that European it’s Q&A session live will that session EBMT high-profile session, the [indiscernible] same excited session. in highlighted data who be the respect the meeting, day. Presidential And the the presented to in a participating will which at

of with themselves, terms panel added the Dr. discussion. In of data nuance same course, remarks TCT and basically in data but the that the some Sanz, it’s his meeting, presented at his set were from

the the open been of terms In on opening haven’t U.S. six updating It’s sites, to study future, this variety the in and of at sites ongoing been is from updates haven’t on investigators point. progress hope a of and an provide we across we patients detail their giving access, some there’s expanded basis. enthusiasm we or The those at number the to outcomes. patients patients. In do But, the about enroll

Roy Buchanan

I’m FDA remains been to that sign the then then going or gating prior full IND And formal, And on filing, to work? here XXX, what has cryopreserved for the how filing? formulation for the this Thanks. IND does off the on formulation that finalized,

Julian Adams

you Tracey, that, please? address would

Tracey Lodie

Sure. Thank you, Julian.

scale. lab. In their terms for in IND, just The finalizing the of has for finalized a and what’s left it before GDA-XXX -- formulation it’s a we of section CMC now is cryo cryo matter scale clinical and really been It’s we’re file with to facility, formulation. in the just a stability of we’re manufacturing, matter And enough before which IND. FDA. active our It’s for the clinical in batches file presumably, discussions yes, of that Israel, be our able GMP for will at now

the protocol them. that’s and our upon the cryopreserved will and the formulation shelf with off both final product be discussed agreed So, of

Operator

Your comes Markets. the line next from Capital RBC question Renza Gregory with of

Gregory Renza

end the the will of the wanted my module for confirm, I you all thanks that clinical just Hey to to and progress, year. well the mentioned on module that Julian be submitted team. Julian, in and Congratulations as shortly, just the manufacturing question. completed, as regards taking believe by --

maybe omidubicel all to now curious their not the with comfort of see set patient level Michele. color there from the just or there? the I’m is a patients data critical just quantify terms in curious great the that curious, of this what and preparation afford rolling the you launch far timeline has BLA as And start as way omidubicel just to year, And of the of hear disclosing just you -- maybe just for the that end the is are the for preparations, number Where right? ultimately? from that does of question skeptical can and analytical final XXXX gaps like FDA and then, get XQ are there likely but the that vision you realizing most extended for would if extensions, getting or comparability to if very what that Thank the Just Michele. characterize in areas that necessary much.

Julian Adams

Yes.

both just and So, We a high talk at start to module Ronit clinical they’re you Ronit, very have let looking do CMC me the of anything to terms as from our clinical analytical a manufacturing the FDA clear December. have compatibility, level about understanding very CMC sites. we turn with of compatibility for to more had in commercial conversation it well and in requirements. And detailed as add? what

Ronit Simantov

Yes.

We for the that shared I we’ve our them told or of and a with five adequate commercial on with to at will results believe terms are in shared the that about three those sites. sufficient FDA them support to be production data -- plans submitting establishing facilities. we clinical data our results think, clinical patients new high-level

terms landed So, in of that’s the where production. new we

Julian Adams

to the Michele, part question second you. the And of

Michele Korfin

both a addressed They absolutely, And Yes, interestingly, the and are question. way. you. was two-part actually in same there thank

to overcome So, able were with down able one So, additional was where have the were for really we us extra and there address now them? few commercial readiness we key allowed to It concerns the hiring. to and what do came challenges gaps, identified what around how months would proactively. to was time three areas, that potential them any be we potential ability

the some too. mentioned, challenges also commercial and I and launch. to would have be addressing been the able with our side individuals commercial specific experience, that on proactively take opportunity readiness then the actual manufacturing both been great we’ve to operation hire commercial for focus as on The commercial two we areas around able to So, on just side

for very FDA but Kiryat readiness at not supply, readiness, in FDA nice approval. for progress just commercial overall of only also we’re very, our for manufacturing BLA, in upon commercial requirements So, terms facility making the Gat, the

around along moving the readiness, that affairs approval So, to area some additional in partnership time team. this is needs transplant And second upon of that’s the potential nicely with And commercial centers then, gave Ronit’s of understand plan. us the to omidubicel. medical

also to of understand focus also and sure and the health Ronit’s the opportunity they We really proposition team education commercial side. on clinical the the the of payers, of omidubicel, omidubicel need have value unmet to that economic terms and great in data with the the making understand partner both from

commercial about manufacturing progress launch excited on we’re the the So, both and side for readiness.

So, Julian, it I’ll turn back to you.

Julian Adams

we And, your follow-up hopefully Any adequately answered on your further question. Yes. end?

Gregory Renza

I color. That’s great. appreciate Thank you very much. the

Julian Adams

you. Thank

Operator

Mark comes Breidenbach Your next Oppenheimer. question line of the with from

Mark Breidenbach

rate of you is little come questions. Hey color for was guys. Thanks have the sort Julian, for a BLA regarding us already in on more that module And have taking application the limiting yet? to if the the give This why you the FDA wondering I CMC could reached BLA is the agreement up. an step criteria with filing? related But some of the others

Julian Adams

product, just it’s uncommon supplying CMC any the limiting there’s a usually commercial mean, particular not I is cell the adequate therapy, rate different marketplace. step more for but lot where in be Yes. that criteria in attention for to and

when this Kite, you your Michele, can as you experience probably at reflect were is So, launching unusual. on not YESCARTA.

Michele Korfin

Julian. Thank you,

from So, at FDA we very meeting. clear the December received B Type feedback

supply for we our Phase a facility, we just terms commercial point and at to to to And of requirements knew on omidubicel were this Lonza is module, surprise manufactured We focus transitioning one Kiryat us. going Gat. X recall different to a we wasn’t be CMC needed the we the for facility. to Lonza, In also Netherlands knew --

compared are the what what on Phase FDA for now needed with December the commercial is to compatibility discussed the the as requirements us in that So, facilities we’re had X. and focused

So, analytical some data the compatibilities, work. clinical these discussed, validation are that methods we of the

on that that. Lonza, at at Kiryat our had and on already some Gat Netherlands this point the of facility out mapped begun work All is time. track of

now also colleagues too. So, takeaway for very opportunity in research readiness partnership us our this commercial also along manufacturing December, nicely gives BLA, to for standpoint big the we’re to clear with from the only FDA our in supply the is clinical colleagues and and was but moving not the assure a readiness assure

Mark Breidenbach

super That’s quick follow-up a Okay. GDA-XXX. And on helpful. just

your to are data you I’m present that seen donors study. sponsored that any either plan cryopreservation or of for the two filling there plans have demonstrating GDA-XXX key essays types to mouse that you you’re versus equivalence that this fresh wondering and in Given between some product differences of later the the academic versions we’ve if Thanks. using in fact year. cell use vitro these preclinical, in trial,

Julian Adams

for your as well. that turn Tracey, question. I’ll Thanks to you over

Tracey Lodie

Yes, you. sure. Yes. Thank

IND donor with out, you the reminder, as will cryopreserved for and It’s clinical same from was product. filing, As be source completely a still Minnesota off-the-shelf a from the study apheresis But GDA-XXX collaboration normal that now done donor. point was a our with material. just from related

present haplo expanded of do, but this at which is do will quite protocol, year So, and And a compatibility this to those the the the ASH, that our presenting majority NAM And the further of as in mechanistic fresh show completely harvest to the cells and to research likely over function conference, cryopreserved, work formulation, NK this cryopreserved at studies Israel. be our have end at the data obviously in sites another new work NK expanded of work we some that donors both after the between present this plans filing we manufacturing we both towards of extensive maybe and understanding work done this conference. present maybe whereas some and will so IND the allo. that NAM the at the is We frozen with both ongoing can of on were continue and the phenotype lab in we that well. both saw and phenotype pre-clinically maintain the we that with time, have cells,

Operator

of Gil with Your next question Needham comes from the Company. Blum line &

Gil Blum

and for taking questions. everyone, thank Hello, you our

outcome saw study, any study. of maybe direction? with a on one. thoughts post So, overall quick you have the or in an pivotal approval that We just do survival a Any the in plans conducting something trend

Julian Adams

that overall me indeed, overall remind invite survival. Ronit follow-up further survival. our let saw were on to comment for of for we trend we I would not So powered strong patients. And you

Ronit Simantov

Gil. Absolutely,

thank So, you.

on well the following we which basically in X all on enroll in for study is who over of approval, study, we single yet terms are follow-up patients a registry follow-up have Phase for time, and clear type will patients, who have are as information omidubicel. the study the of at But, do CIBMTR. real transplanted expanded our that the this the U.S. access don’t additional arm in by So, plans our in in in Post patients will patients additional followed world. patients as point of any

So, there an in that leverage setting. post the may be marketing opportunity to

Gil Blum

question. another of kind maybe And Excellent.

engineered So, allows a for hematopoietic of stem hematopoietic Any the we benefits of now, cells. cells. It purposes? expansion you’re this see lot using different therapy NAM thoughts at the for looking about platform. gene And stem

there. large really is this believe I So,

Julian Adams

good expansion report of But us. keeps doing entertain mechanism And quite a very lot expansion we And the we cell the lost at on laboratory platform be exploring to understand on again, platform we board. giving, how preclinical can to and avenues other of work think And a specificity types. is with the point. and across this action the greater this It’s universal time. this stay of are is setting. applied in have a because different are gift nothing as number of this we think that we tuned a that be And will not

Operator

further to are to back call any Julian at like for over I’d There closing questions remarks. And turn time. no now this the

Julian Adams

forward engagements you Thank today’s look exciting and with we all. an Thank XXXX for us future you. to on you joining and call, everyone

Operator

today’s concludes call. conference This

You disconnect. now may

Gamida Cell (GMDAQ) 9 Mar 212020 Q4 Earnings call transcript