GMDA - Earnings call transcript Q3 2020

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Operator

Welcome to Gamida Cell's conference call for the third quarter 2020 results. My name is Shannon, 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. Josh Hamermesh, Chief Business Officer. ahead. go Please

Joshua Hamermesh

quarter and results during Shannon, at the everyone. to which release on the Welcome and we available this Thank a is progress issued we good across will www.gamidacell.com. call, press third for results which our our on website XXXX. provide today's Earlier review morning, financial you, summarizing financial morning, of and an our company company, update the

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

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

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

to to I'd Julian. turn like over call Now the

Julian Adams

the to diseases. rare cancers Cell, we with patients us joining everyone provide cell Gamida cures Josh. and are therapies At Thank for developing to you, And hematologic morning. for thanks committed serious potential to with blood this

the graft hematologic with have of engineered programs, to the transplant, our to bring both which Phase both our therapy, engraftment, tumors. commercial of cell. were months, we'll which the clinical the results study Duba hospitalizations. Oma strong positive platelet few all malignancies summarize omidubicel plans we randomized for to related infections These report global first NK review Today, very thrilled secondary year. our in met has in setting. and GDA-XXX, could we strengthen FDA-approved Starting for this patients both and in over and the source bone be potentially data potential reported killer endpoint III cell or build to around We omidubicel, In endpoints progress programs past and marrow a to continued omidubicel and natural with solid October, confidence earlier make upon primary X the omidubicel potential progress our

clinical to the by report additional of the the details year. expect We study from end

on XXXX. We a of in us omidubicel also launch BLA rolling which basis initiating anticipate potential the a quarter, for fourth positions for the half second the in submission

We bring to with are following launch making patients good also other omidubicel potential progress key activities required approval. to FDA

expansion the potential the product led hematologic cell malignancies. care cell cell-based of NK tremendous of our GDA-XXX, Our offer therapies also NK generation for platform candidate. transforming to

with the power GDA-XXX, address in harnesses our Data cytotoxicity, potential which I the Phase vivo are of cellular improves We uniquely offering of similar an with complete NK and profile. homing antibody-dependent in to cells. ADCC, that limitations goal a in to from off-the-shelf ongoing our as novel expansion of pioneering responses to signs of study the cell be the early rates approach response lymphoma. multiple potentially cell patients With safety a more is efficacy, therapy GDA-XXX with demonstrated pleased striking have technology, favorable known advanced develop our to CAR-Ts allogeneic lymphoma,while

ASH at updated month. our Ronit abstracts ASH or detail. Hematology Meeting Annual presenting be We will will next American for review the month next data in Society greater

our will for I/II plan be to study a lymphoma. patients which trial, multi-centered with We Phase are advanced in next continuing

a formulation on enable our of formulation GDA-XXX scale-up GMP IND to developed submission this cryopreserved are have working and of We in XXXX.

hope serve basis the are to is approval a registrational accelerated pathway. trial if this compelling, as an for Our study the could data

sciences appointment advance potential programs clinical and As Senior bring prepare we the our of Verastem, roles further within Ariad at key of to launch the we make continuing year, strong Steve organization team. the experience, next in years a Information the Today, role for of XX to brings Infinity, OSI. Technologies. announced Steve who and life Vice President capabilities and new industry, hires primarily our we're Jamieson enhance IT including

Additionally, Market securing as nearly organizations, XX patient in Vice this commercial patient for Kite instrumental market at including support relevance, Celgene years access experience of and has Of was Cell Roche. in Manghani leadership and joined week, a President, Senior particular in and served Gamida a Rocio at Pharma role Rocio Access. She YESCARTA. access

look forward a challenges as to toward year. look are we and pandemic. my launch as Cell contributions global this Gamida navigate remarks welcome We the the excited to potential acknowledging year to their and by Rocio Steve of next I team want we a conclude to omidubicel introductory through

in to health employees facilities, travel safety regular implementing our and laboratories COVID employees working and committed of while the business for and work from policies, our site. our home advance shift bans, and on are continue We to testing work manufacturing

both our timelines milestones anticipated and watch omidubicel very unchanged. carefully. We for Today, are our GDA-XXX to continue

launch end of the basis -- to second XXXX We second continue rolling to a BLA which in for expect for half the the a sets by us approval on of up the XXXX. submission year, the sorry, half omidubicel of initiate and in potential

and study to Ronit? to for am to are are turn now over bring very Chief Phase the Simantov, update of submit of patients, hard call further multicenter lymphoma proud enable our to and on in doing next omidubicel GDA-XXX. and I work year. IND by provide our employees. dedication Medical our to I/II effort impressed an work the the we Ronit I'll Officer, the a am to I GDA-XXX We in planning cures

Ronit Simantov

good the in omidubicel review and highlight GDA-XXX This non-Hodgkins describing patients recently morning, patients aplastic I'll with programs and severe Julian, our for of you data morning, published study in clinical everyone. anemia with lymphoma. abstract and ASH our Thank from

Julian primary have met study global malignancies As that and this endpoints. patients XXX endpoint the III reported with Phase omidubicel hematologic our of all noted, year, we in X secondary

transplant, healthy omidubicel days comparative engraftment new the group, improvement was p-value to We especially demonstrated XX study are proud COVID-XX. for prespecified appreciate in versus make the to Last field tolerated. well-executed help primary randomized the received and we And working I'll randomized was who that to are all stem In what secondary a with omidubicel announced showed to blood and patients us became milestone cells. trial. to bone truly briefly days how cell working neutrophil we've the statistically far. omidubicel group. a time key engraftment, analysis, generally that patients than in endpoints recovery well we The of highlight neutrophil this less from was In of X significant cord signifying May, the through transplant. randomized established month, quickly comparator we rigorous of the collaborators patients forward, reported while among XX move our that so began standard its compared met marrow the endpoint, study transplant The announced support median community in time X.XXX. the patients intent-to-treat the to the study

transplant. all platelet or endpoints following hospital day fungal first or number incidents days the grade alive the XXX days engraftment patients immune reducing bacterial by valued and by secondary infections, clinically hospitalizations the and were the are X of out recovery, Specifically, in Rapid physicians, infections family. and outcomes, invasive XX, shortening their grade and X of meaningful of engraftment

in cell in was omidubicel and be highlights old, for with Dr. treatment donor. the initial median rapid omidubicel look peer-reviewed and respectively. being beyond who December reinforce cell study, Phase The from post-presentation platelet acute presented sustained independent. adult the patients this Phase cohort XX myeloablative study second at successfully life-threatening of in ongoing, data underwent years published of consisting on unable of of transfusion believe omidubicel graft option and a data, observational at recovery has in X early still the make year. who We patients the end more included from abstract last Institute conditioning, graft. reported X National are and patients and anemia, remained are stem aplastic omidubicel The feasible tolerated Our and month. omidubicel cohort belief evidence marrow evaluating I/II week and X these for patient blood disorder. patients a a plus a stand-alone X omidubicel of Initial the less could frail option will ongoing, follow-up patients at that patients these to with There patients suitable a Overall, transplant by to reduced-intensity in diseases previously X X. omidubicel or used does GVHD, XX and of cohort III a at donors data a virtual analyses forward to non-malignant well Dr. still more is a and data was in have to omidubicel haploidentical graft. engraftment data rare an further present led reduced-intensity with forum lends months, of cell an stem days, the to which cohort received regimen. from With conditioning evaluate support evaluate neutrophil, Childs no as of we at coupled that cohort elderly important data match with a We data study, omidubicel recently severe showed broadly had hematologic a which engraftment. patients led our X. be initiated Richard hope our days withstand to improved The to and or regimen showed presentation Health. We others generally sustained XX then or This ASH our of median the X bone next Childs for Saturday, in is investigator-sponsored chronic of patients ASH occurring XX be the which potential not presented data the any using potential could survival a malignancies, than

that cancer. have In are for to tremendous killer our advancing addition held promise immune Natural treating innate cells NK cells we GDA-XXX. are program, omidubicel,

However, the to several preserving cells including has functionality. the field expand and developmental culture NK their while faced ability challenges,

concept. this of The as data of provide well designed monoclonal challenge, Phase multiple safety Minnesota. the as non-Hodgkin lymphoma and doses of myeloma, which relapsed in is recommended patients I Phase study impressive presentation, XX submitted addresses conducted in by a for increasing GDA-XXX lymphoma technology The being to from Our cutoff with to combination with in proof accepted is as refractory Veronika of ASH, determine Bachanova dose. data XX with myeloma. The clinical antibody and X study oral patients patients or July the multiple at with our assess includes or XX University abstract Dr. to non-Hodgkin patients the II of the XXXX, was

note of had XX% B-cell lines, a with with prior lymphoma, GVHD, X who toxicities, GDA-XXX stage First, it's and lymphoma treated lymphoma. X of and range with were generally on Patients with lines important X rituximab. I'll to observed. with with importantly, patients neurotoxicity diffuse focus had that median disease. lymphoma, was no and follicular included dose-limiting of a and advanced mantle non-Hodgkin tolerated X the X X large no patients patients to XX no cell patient therapy, Histologies GDA-XXX well with

partial which responses to X out were evaluate patient begin potentially GDA-XXX patients there to in underwent our is population, chemotherapy, note, multiple patients, for to the doses this response were an in with evaluated. company-sponsored to we and XX requirement that Median X complete abstract for our was see population, months overall to XX patients. Given and exclude X.X duration plan This X this of response without to these were these lymphodepleting response, see contributed encouraged among all responses expected at clinical rate reported XX%. of activity months. which we and retreatment doses XX to Also responses year. study, likely in next thrilled The of deepening of lymphodepletion of supports finding

to I Shai global of their as month, as already commitment will our our from the enrolled additional presentation over turn ASH, advancing this evaluable in and expect time oral during that, patients proud patients to of both since at well were just to additional the a few the submission. I'm from to follow-up abstract call the look And ASH I longer-term we at pandemic. to Next clinical data With programs results. and reported who forward for data include in studies review team weeks. sharing very our

Shai Lankry

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

preparation, third expenses the XXXX, and and were $X.X was mainly to XXXX. the of The the million compared travel in XX, to cash The $X.X same as same Net omidubicel net, the million GDA-XXX last mainly $XX.X the $XX.X XXXX a December to $X.X increase had compared the expenses. compared due General loss the quarter $X.X increase omidubicel $XX.X driven was loss reduced to to in total readiness The warrants million period the related for income, and the million attributed company's year. compared primarily Finance XX, resulting initiation As period same expenses quarter in the year. by net from for for noncash commercial decrease was readiness to of of the million advances of $XX.X for BLA of period mainly for the revaluation of in to for and of were were million due in same study. $X.X by Research $XX.X shareholders. XXXX. $X.X of to decrease period million million clinical in for quarter increase compared million September owned same was income we quarter the last period The cash expanded activities. to was compared in million million the access XXXX. administrative Commercial quarter to $X.X activities was equivalents development XXXX. million expenses

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

Julian Adams

Shai. Thanks,

With transition and are our year. have with hard of committed initiate hope own With We our momentum opportunities a approval finish year present patients Phase for for cures compelling submission malignancies for GDA-XXX, initiate potential blood transformational expect and and of ahead. be omidubicel, to lymphoma we U.S. and are clinical which could Gamida trial to as about III the Phase to registrational our carry in a the hematologic are which we we to the and excited finding into to we omidubicel if a data to our year study, consistent data very the we by ongoing rolling with disorders, BLA I Cell prepare working launch our XXXX, data end to the in are We strong and study. expect the

Now for Operator? we questions. call the will open

Operator

Instructions]. [Operator

with comes Evercore. question Miller Jonathan first Our from

Jonathan Miller

I'd they progress. blood looks of It cord those trial not sources. standard clearly was sort -- blood obviously intriguing superior to Well, to and the against start all on the congrats very had love cord omidubicel. . And with other

you in do So commercial that combo docs GDA-XXX, you're are broadly broader are your a mostly you I payors, the with initial replacing in I especially there structuring space of trials? outside very have versus you immediately cord obviously, be start set in expect but and in the And targeting? other omidubicel's just modalities cord? NHL? with planning to transplant Or malignancy how potentially just myeloma? be a data you on Do how in Is as sign they guess follicular other potential the ASH And How of way update hemo that better to of next expect characterized sources different blood, in not agent? NHL. replacing know activity Do the any then mAb well? interesting, and abstract you to looks on that conversations there hope meaningful approaching

Julian Adams

Ronit Michele, How comment marketplace. and then, do And your view first other So launch omidubicel cover to ask could with our modalities? you to introduction compared part the the of omidubicel potential of data on let question. activities transplant the me with physicians

Ronit Simantov

how Thanks, Julian, omidubicel. to are physicians and I will start reacting with

neutrophil for after to no is graft to what generally rapid get out improved source. an superior have So engraftment to attractive transplant room, have lower It's the opportunity other matter infections a an isolation a outcome patients have of and incidence of to complications, outcomes. and

are from endpoints endpoints. speak very supported the that other the level And physicians relevant secondary clinically of with we by to the engraftment impressed we're that the so seeing,

source potentially in another for a omidubicel have from patients attractive donor So an source. is matched don't that graft we suitably believe who

Julian Adams

Michele?

Michele Korfin

Thank for Thank the you. you Thank Excellent. question. you, Ronit.

So clinical based be Physicians to omidubicel, a and match the with of our time related our patient. was cord by and on for With identification have for the clinical I'll candidate. the in provide reiterate very manufacturing does efficacy, return ability from access physician. payors the an experience what omidubicel Ronit donor, have of safety the the omidubicel. weeks If has the date there the to is the encouraged discussions not profile to for across said potential of been trial, to patient until X omidubicel them

efficacy, So have physicians. from received feedback those logistics, safety the very encouraging three and aspects,

modalities from an So there a omidubicel current opportunity is standpoint. for graft all treatment source

add joining Now to indicated, us in personnel Julian to commercial Manghani to week. including exceptional this we're our regards team, as begin launch, very to Rocio excited,

in of in team up potential a launch XXXX. So of we're half expectation building the the second

is assuring to and focused experience on center transplant the be going omidubicel patient. of the absolutely a for launch positive Our

for on. the clinical prepare profile appropriate been to payors. to So will very the they hence, understand to launch. by encouraged the we're educate we continue initial tenants the make but Educating in centers, that so payor We've sure that feedback, key omidubicel patients. we recognize transplant the important be have working the on four Preparing we

Third chain group established appropriate support. is of to also any initiate identity help then support reimbursement is manufacturing that the additional decision, And provide to is at the key time having around fourth but that assure treatment of that, or patient readiness. the to area

progress areas. excited of all four So are those by we our in

the thank question. you for So

Julian Adams

other so And for Ronit to ask related monoclonal Tracey I'll ask experience the antibodies. to the again combination me clinical to GDA-XXX, about potential talk on comment far. with And then let a

Ronit Simantov

Thanks.

GDA-XXX, terms we've we're So aggressive of histologies far data in impressed so both indolent and in histologies. in that lymphoma the observed very with

that what will the opportunity so And we with methodology different to foresee is histologies, obviously, study appropriate next our evaluating separately. GDA-XXX include evaluate them the in for

And can say We study. our next so I include think of that's the will that it both. about what design

antibody myeloma, level antibody. In see we there terms lymphoma. It could explore the may of or a And that responses opportunities to we using different a myeloma potentially of different just tracing. alternative be attributed either the didn't methodology, in observed be to

Tracey Lodie

what particular, combo around that do Thank will we you, multiple your in and with data, think we're not myeloma, question is to given I reiterate the believe, non-Hodgkin's see And very so the lymphoma. yes, Ronit. antibody, we research that we In excited elotuzumab, about optimal. particular

antibodies will our to be trial And more engineered program research a year. will think working which so in be allow actually different this we that us not next of modify cells, genetically the But are combine NK part will myeloma. potent on multiple with we to

of excited cells we NK of our that, addition continue activity the with about to platform. and NAM-expanded the be In cells to safety NK

we in And present conference we work have will year. will do tumors a be well, combinations and that future. sometime at that solid at programs antibodies ongoing So hopefully, as next with looking research the with

So question. thank for the you

Operator

Ted from comes question Tenthoff Piper next with Sandler. Our

Edward Tenthoff

a you for approval. company exciting that you and wanted really I that seek to to have the on. get wanted I going sense think Again, confirm guys designation a lot breakthrough would time for accelerated

a seeing been [indiscernible] [indiscernible]? require have you do And the pandemic. We of this anticipate would

Julian Adams

So you your for I'll Thank take that, question. Ted.

is not an a approval, all our breakthrough designation. will we review. with anticipate -- of and is be Phase which, we X-month you as pivotal don't we But But advisory and this significance. secondary therapy met primary have to a priority And just committee we need we've full So we're seeking seeking do for know, because accelerated points, reiterate, both endpoints, III a review do study, approval. end the statistical

Operator

JMP Our Securities. next Jason with from question comes Butler

Jason Butler

Congrats progress. all on the

First one, omidubicel.

sense aplastic of how through the here on through And the Just the what in a in market population just extent the to obviously, for can patient process it's today give then but the of size rare work just submit dynamics, the change and be and XXX, that what us options indication, anemia can that? a update done the terms to the any you are omidubicel you can patient needs And you're manufacturing U.S.? walk of IND? to us

Julian Adams

Ronit, could anemia? you discuss aplastic

Ronit Simantov

Absolutely.

tend young. to mediated low transfusions be disease got be blood have treated to So where the marrow red and but patients Patients aplastic it's can with And attacks in cells very only and because distribution, bone cure is anemia anemia to are very dangerous. other the the bone the with bleeding aplastic are infection, time and platelets, severe transplant. They susceptible immune aplastic complications. therapy, that for system of severe are most counts support It's a immunologically anemia with of young immunosuppressive patients bimodal most their and marrow. the

a For really patients but on subsist don't really marrow no there opportunity than for no supportive here other match, is have therapy there's transplant. a And bone who cure. they

And who in omidubicel particularly sector. Particularly So were study results important is offering important in a the the way rejection. published a a just potential the what immune with marrows have of engraftment. are because because there's transplants of is system with anemia match. The have easily of graft tend in and for aplastic don't difficulty a patients in patients higher rate the don't this take got aplastic cure that supporting bone severe anemia patients the to ASH

a of fact single unit positive is actually very, omidubicel very And engraftment sustained a the so support that a sign. rapid and

disease, just is that U.S. not the aplastic for a the may numbers currently. rare a in anemia exist Severe can are omidubicel and patients offer patients in for them what XXXs. for potential measured the cure of So these

Julian Adams

talk Thank our manufacturing? you. progress in about can GDA-XXX the Tracey, you

Tracey Lodie

Sure. question. And thank you, Jason, for the

clinical remind Ronit results I'll just product Minnesota. our with that collaborator that fresh the So with were summarized in just a you

at we've making in So a tremendous formulation. progress omidubicel, cryopreserved made

is intent to have an our off-the-shelf So product. next cryopreserved year

just GMP this We we clinical matter manufacturing conditions. we're actually the Gamida under of it's manufacturing this have trial trial that that some And for have final product capabilities next But flexibility we a Allo formulation external year. the And to now, next to for the having looking manufacture Cell. also year. at for for and at remain for on track off-the-shelf

Operator

comes question next Renza Gregory RBC Markets. Capital Our with from

Gregory Renza

Congrats on the progress.

Just to for factors there margin? BLA gating What Are perhaps as build you're components some path you And waiting filing. critical this? of a any just do each earlier on questioning for to the see that the progress or module around still half of take terms light in data each long understand in how trying potential? to will Once or or I'm the perhaps in second of information? for total just for XXXX timing. your start expectation that, that launch of goals the you

Julian Adams

Yes.

cover me the sort let So cadence of filing. of the

And X-month the that Our we filing the the will CMC the beginning Module within that's nonclinical followed is module. And year be -- by frame, lastly, the time of X, clinical the module, ready, early will filing a module BLA. anticipate with manufacturing full next and that particular complete section module.

Gregory Renza

on on opportunity process? protection questions Very an omidubicel. could if take the of then, to you wanted provide respect see certainly to this product you view And your I helpful. but the you. property spoken just of there Julian, intellectual with Got just to we've just some get about the have the color and before,

Julian Adams

happy be I'd to. Greg,

that XXXX. longest in XX consumed orphan the have we manufacturing where have inventory. personalized Europe. the public And drug exclusivity because And in but because omidubicel no is omidubicel trade number in years and secrets many by finally, expiry, patents, domain. patient, patent we XX a a we is we But there's recipient are BLA of Our our status, not for have have years expiry's importantly, U.S. out patent to a quite the

really it's to So a possible biosimilar. not make

for And very, so us. we the that is period strong feel exclusivity very

Operator

Our Bernardino next question comes with H.C. Vernon Wainwright. from

Vernon Bernardino

progress to And as was far guess the provide begun? on supply in just Phase October the also remind And you if on, omidubicel unit on could key that of blood need of Be the you supply? smooth us with blood be seems far any the of supply the again as III and as very A strong wondering results. therapies The and pandemic expansion to cord the Congrats any I me far the of as units? on then the any announcement donation be to commercialization our I to units. as Match effects Can done effects for once supply core you comment as of done the if -- would effect, what of have what pandemic there's has a process collaboration the

Julian Adams

turn to I'll about by Michele talk me begin discussing over the and to pandemic, it commercial So then supply. let

actually ship it no because would made happen, are units cord it to volunteers As involved. blood easier it there

donate willing were infusion in So and Match. based go not to and comment hospital the with we all on settings. with the still units delay come dampened pandemic could reticent shipping to you the agreement their -- routine, Michele, a that And are for and The And because, a supply experienced the has they by cryopreserved pandemic. donor, certainly locate to Be And donors the was with a adult to bone maybe never that's healthy unrelated center marrow. matched to commercial donor, on be to one donate an of to since and have sort obviously, case blood they cord

Michele Korfin

And question. the thank Vernon, for Absolutely. you,

with our to The Be Match. excited continue So we're partnership very

and the that we're potential Phase we approval. said study, of the them I Be center important for what A had part transplant So back III centers partnership is to relationship earlier. an transplant FDA and to upon Coming important The launch for have experience partnership patients. a for an with had commercialization with established extend very positive the very, Match. our assuring The excited

transplant Match the beyond for donor able already partnership, for matched partnered us with being related The it related center of Be continue continuation graft looking our to donors. provides by are they that a partnership a the source when So has. They the or

it to approval. partnership. very streamlining We think to that terms do potential So the FDA be with omidubicel be using transplant excited the will associated continue we're of logistics able a upon that centers beneficial in for

Operator

comes Needham question Blum Next Gil from & Company. with

Gil Blum

study initially? Gil is bit you My a for expectations regarding Chad. are, planned question at is of on clinical discuss that's the least Could for little next your GDA-XXX This year. what kind of

Julian Adams

key will The cryopreserved will ask Ronit study. histologies, to I/II of it going feature let be study. patients. be Phase enroll and about And It next be, obviously, off-the-shelf of to talk different as year's me a trial cohorts we're product, within multicenter how designed will different a

Ronit Simantov

and Julian, thanks. Thanks,

yes, think you I I So much pretty think this. captured --

So different what it enroll much best we separate study features that to as order the efficacy of cryopreservation did are histologies. of in the because cohorts will the to be in and in will allow sites, patients is a understand with us multicenter the will omidubicel. ship that histology them analyze And product different we main those to lymphoma different

the -- terms in think expectations that's those I strokes study. of are for the that broad

Gil Blum

to on furthermore, use considering of GDA-XXX, of the therapy, care? And in standard multiple cellular context could the ability especially All doses you right. put

Julian Adams

Ronit?

Ronit Simantov

Sure.

study I/II patients X interest So was of Phase X second in of cells of there using conducting at reasons. the in dose for the been GDA-XXX in study, we've that a Minnesota, in

responses were able the wanted patients without to cells we was after deepening prior in explore First, administration. that to lymphodepleting deepen perhaps, chemotherapy doses able dose. of were X lymphodepleting to And additional the administering But patients if patients. that more tolerated there And we see had possibility or of importantly consolidate who would we it to second second, wanted administering dose It additional were with lymphoma. evidence we in see response without objective of chemotherapy. and fine, administer to

in that, for opportunity administer explore doses, so to And we that we think interesting studies. multiple with that's us, further an will and

Julian Adams

sort pertinent of think that ideal. biology One we're certainly we with that's for the think the That's of what adaptive evidence there's lymphoma of GDA-XXX. -- That's that our is response. development clinical in of immune NK combination the And that. is think our is to that eliciting tenets an we rituximab -- in we cells that NK of are approach cells

Gil Blum

on That one One last makes sense. omidubicel.

press You a have release beta guys match. about did

about Match are be Going, The guys cord with sources it forward blood? have sufficient? at look other think going market relationship as do I to thinking Or expands, was and to Be your will the you you of

Julian Adams

Michele?

Michele Korfin

Thank you, Gil, for the question.

of extensive So now with for as They with. are centers. also Match. Be transplant very that We They a have partnership in network about terms The but utilizing not the I core prior, much amongst mentioned would for very, blood we're don't a there a very be partner, us, supply foresee only very the banks. challenge excited the

terms the at see in in from supply point Be don't this a concern time, of Match. So we The

Julian Adams

year States. I might babies are million there born add X to every in that, the exuberantly, United

we So long is an inexhaustible patients. serve think that, supply as to omidubicel ultimately, this as continues

Operator

Instructions]. [Operator

is Mark with question Breidenbach next Oppenheimer. Our from

Mark Breidenbach

FDA reached to regarding kind alignment an on omidubicel. to analytical questions the with have Two FDA this if of that the would CMC I'm the is that review? you've especially curious of just package, contents given the a product of With first its respect filing, BLA the

Julian Adams

So we're enjoy and designation, they're details one commenting often therefore, on those of FDA. -- would not say breakthrough the I we speak very collaborative. meetings that do discussions recently. in this including discussions. and regular the had cooperatively. But with FDA very We're the and We've We multiple the therapy year,

Mark Breidenbach

I'm stay a your important in just And wondering reporting Phase upcoming defined of you III other will rate? if And you treatment-related think graft to threshold the trial, below data varieties? Okay. there's be to relative that it's presentation from TRM mortality

Julian Adams

would care you comment? Ronit, to So,

Ronit Simantov

to comment that. on Happy

to of associated Phase in mortality XX rest was in important I/II. transplanters and secondary the patients. Phase data, data in share we efficacy the lower mortality endpoints and neutrophil treatment-related the Certainly, the very of to engraftment patients the rapid present those the the rest And the data and when we So for single-arm with safety study. of will our study, issue treatment-related I/II is

Mark Breidenbach

specific -- stay Okay. But do thresholds important that think no it's below? you to

Ronit Simantov

what other I that that benefit, the would we've associated with much clinical are give our we've some then consistent seen. data of study, relatively think as if we observed observe endpoints clinical engraftment previous in us with rapid that that is confidence

Operator

over call questions no back closing showing further time. to for the I'd this currently turn Adams we're to And like at Julian remarks.

Julian Adams

call. for Thank joining on and us you, thank you, today's Shannon, everyone,

to weeks. the We additional forward the and looking meeting program in coming ASH virtual sharing to are updates Shannon?

Operator

That concludes call. today's

disconnect. may now You

Gamida Cell (GMDAQ) 11 Nov 202020 Q3 Earnings call transcript