GMDA - Earnings call transcript Q1 2019

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Operator

Good morning everyone. Welcome to today's call during which we will provide an update on the company and review our financial results for the First Quarter of 2019. With me here today are Julian Adams, Chief Executive Officer, Ronit Simantov, Chief Medical Officer, Shai Lankry, Chief Financial Officer and Tom Klima, Chief Commercial Officer.

Following our remarks we will open up the call for Q&A.

We also issued a press release this morning summarizing our financial results and progress across the company, which is available on our website at www.gamida-cell.com.

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

XXF SEC to considerations our Our results that statements time of new Form described and we on annual whether need risk as you to section submit of due in statements events, SEC views update materially of on important future our report information, we project may from the time. with with of actual looking future, number otherwise. the them what forward we a we factors, registration February the caution from an that filings differ other as today may the a These result only filed including or the today, to factors represent not XX, in

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

Julian Adams

Jaron. our Thank and to leveraging to At are we And the curative technology new hematologic nanotechnology therapies with Gamida serious and potentially malignancies disorders. Cell to this time cell for join or bring us taking cell patients morning. you, blood expansion proprietary to everyone thanks

most to development NiCord enhance Our advanced bone is designed transplantation. candidate X and the of is product in Phase marrow life-saving benefits

investigational cell which immunotherapy, an killer is X natural NAM-NK, developing development. Phase also are We in

NAM-expanded recently announced omidubicel cells. changes investigational this Names highlight we First, our name Council name to States for proprietary for as The selected I Adopted two want today or USAN the our programs. United

milestone progress clinical non-proprietary omidubicel. omidubicel as patients. toward NAM development to and Going marks forward, will refer our The selection we of to bringing highlights a and a NiCord

key company in of for also A high NAM-NK reflects patients multi-product future this risk plans hematologic enrollment in X our to changed designation study year omidubicel malignancies. to Phase allows the development finishing us standardize build candidates. for priority is a GDA-XXX, and designations our We this with

top the We in data or biologics end first second complete launch submitting expected U.S. of the XXXX. the the with half to data line in enrollment and leading the year, potential XXXX expect the omidubicel to FDA If we in by license application half in are positive, for BLA anticipate of approval this XXXX.

We our a the will streamline filing file enables work a Europe. to use document marketing in required to common for application technical for regulatory authorization for us omidubicel MAA which

of the joined of ever the Cell required in and right Cell just year a launch knowledge Tom We company's products the the needed therapies have first of Earlier the Officer. and including industry pharmaceutical at transplantation. He started Tom global brings oncology. XX six launch. nearly as up has product the infrastructure class establishing ramping Chief field in support successful joined Klima oncology hematology omidubicel patients. significant in for in to to activities with time to bring Commercial Gamida begin first this novel Tom team, led services therapy, Gamida the experience cell years the

Stephen and be the for we Tomasello who field cell of forms our operational Directors. of earliest financial transplantation the to Cline and Wills and expertise marrow Shawn omidubicel. pleased members, of of the the one development Board key two Bone nominated are is therapy, bring revolutionizing to forefront also We commercial, Bboard at of

cancer approach cellular system the cells as immune is witnessing next generation of innate through the or harnessing new of also in medicines, natural a garnering NK killer cells are immunotherapy. emergence interest We the

X/X GDA-XXX are our earlier the in multiple year, to cryopreserved complete formulation of Phase responses encouraged this evaluation in of year. We clinical generated by patients manufacturing we next by up scaling a data enable with multi-dose non-Hodgkin early investigative are study lymphoma in our GDA-XXX. Emboldened Phase of study the X sponsored reported a the multi-center, process

potential combine with improve significant the now established solid are efforts editing we with The because Editas the and to research antibodies. tumors, malignancies have could this potency NK to excited to opportunity cells about to effectiveness call to allows medicine hematologic and Ronit our modification. persistence allows in effective the the Simantov. increase a turn we NK two with addition NK whether their This through agreement a of developing NK broad to over I agreement our more further evaluate gene is program companies genetic to cells. even us our year, support We in cells. will the range of explore Earlier

our Chief to detail. Officer Our review more Medical clinical in studies

Ronit Simantov

U.S. Julian. morning Administration omidubicel the the and share transplant to call first joining Omidubicel program. both an update breakthrough everyone bone I'm to the and therapy Drug and on marrow to product today in from the Thanks, and designation the U.S. Good GDA-XXX orphan receive Europe. also is drug designation received Food the pleased has

estimated to have is more eligible matched donor. While for patients It a a not reasons, of find that of the transplant marrow including XX% potential. inability bone number do curious transplant receive than a

Additionally, of a Journal durable and in to X Phase for with bone of standard the to of to evaluated days spent cohort and recovery the recovery hospital strong transplant resulted for but have clinical have and The omidubicel our of of that time study omidubicel host patients of not neutrophil hematologic safety rapid to patient limitations suitable these a needed profile omidubicel shortened neutrophils the transplanted as match have cell, who XX nearly patients versus did umbilical trial critical risk study recovery data treatment safety who and the to omidubicel omidubicel X/X high received activity omidubicel in that bone The the was Oncology. demonstrated infection blood. with disease. a address rapid This Phase median also received marrow malignancies Our We and in donor. published X/X transplants observed engraftment patients robust XX% complications recently provided marrow study Clinical improve XXX observant The potential such clinical graft from received reconstitution in compared and has who factor the platelets. risk risks, other believe cord was The including of the outcomes immune key neutrophil patients by approximately in patients. Furthermore, cohort. and our Phase who basis omidubicel world transplant. patients in compared of activity standard real in for fewer a had

the an forward marrow blood registration have efforts safer complete to making to at X Phase Importantly, truly of additional accessible by difficult to end of and the and pleased with our we transplants engagement endpoint criteria bone transplant and study. participation sites the ongoing keeping thought XX as investigators year. this enrollment patients We're to randomized bone and appreciate gratifying level and expected marrow would we centers to It's to enroll. consistent with have previous more in and trial of we this enthusiasm derisk been community the seek from with the is study. enrollment important Positive transplant cancers. work the data open patients approximately step of completing threatening study as The with the backing study X toward we the be towards the historically investigators of Phase by life as trial

reduced and blood severe, an In sponsored marrow receive investigator a Last the evaluated threatening a and initial the patients enrolled to a showed addition X cohort in study, all TCP stem a or a recorded with bone approximately February, graft. conditioning rare intensity next The hematopoietic anemia, cellular a Phase initiate plus underwent Phase meeting. to will following The of transplantation first standalone omidubicel patients as X/X that a step classic transplant second life graft we the successfully who omidubicel data ongoing cohort and is in regimen. at disorder. patients of omidubicel three consisting study XX data is being therapy cell

begin patients expect GDA-XXX, immunotherapy. could to omidubicel the intensity feasible soon, enrollment I'll or and cohort investigational omidubicel to a to broadly treat development patients a cell disorders conditioning more using a full an addition more blood others for treatment now into option which to unable evaluation second withstand this failed make We future program, supports omidubicel to our NK of conditioning elderly turn regimen. in with for study non-malignant reduced potential regimen this

to functional cells of have as While possible recognized cells a numbers a culture. been cancers, various key sufficient approach treating breakthrough NK and been generating has limitation

Among that GDA-XXX were in of We combination and patients well GDA-XXX with encouraging heavily of reported the in focus patients thrilled our antibody a multiple limitation. in with activity, non-Hodgkins six to overcome we responses tolerated of complete or disease. non-Hodgkins in of was NAM this of with achieved initial intention were or valuable subsequently elotuzumab advanced with the lymphoma lymphoma, lymphoma, response non-Hodgkins received myeloma. with We generally and evaluate The transplant or rituximab received and pleased patients one patients myeloma. see safety disease. study with partial combination data three bone to Two curing primary combination to XX patients a for patients we in are to first was a the using the refractory response. TCP the these complete see with -- who an technology Phase At study X meeting, multiple the pre-treated who their marrow GDA-XXX and our from the with relapse

X complete expectations safety a very in our reported dose patient patient with response a with population terms Phase and disease. also a finding study the myeloma. in exceeded This multiple of We clinical observed have in advanced

to of the We study data expect from half additional second be in the XXXX. presented

forward As a of anticipate Julian non-Hodgkin move Phase development with year. plans multicenter next multi-dose compel us in clinical study we clinical X/X patients lymphoma with mentioned, to our GDA-XXX these data and initiating

the patients potential life complete oncologist, GDA-XXX threatening responses prognosis. are cure I'm very with elicit who with As excited a to hematologist in patients and about facing omidubicel to a

to to to results. our intensely move turn executing as is Our team bring next patient. focused on review to financial the these of a generation we therapies over forward will now clinical programs the seek to Shai cell call I plans

Shai Lankry

Good Thank everyone. you, Ronit. morning,

made to advancements quarter this XXXX. and first the far financial for on build from of read year. this course I you the with we are of pleased progress the summarize so results and If year continue will Julian our Ronit's over now we the I have

the establishing non-cash same headquarters were million increase and in million related X.X million and to for $XX.X to expenses for expenses. $XX.X As compared to the the due rent expenses the compared million was XXXX XXXX, compared primarily increase total million the U.S. XX quarter million December Finance to as expenses securities Research net of XX, $X.X non-cash for equivalents cash sale available of resulting in other had XX.X first Development million, was were $X.X the and Israel March of in was in period first period and Ireland XXXX. quarter period the loss services, X.X for due million, were last mainly compared cash, a advance million same of we and XXXX. administrative the year. from to Difference from of million The and in quarter to and activities $X.X year. last expenses increase period expenses General to and $X.X related million XXXX. in professional X.X for to to for the Net GDA-XXX Innovation net loss Authority. was million, same to same received $X.X increase compared programs. to mainly of clinical [indiscernible] X.X revaluation the quarter first for This the grants omidubicel the cash related

activities to current million to anticipate million continue XXXX $XX anticipated expenditure clinical cash our reflecting to ongoing advance operating programs. We $XX for range used to in from

guidance our in omidubicel for data of readout Phase which call This through our We the [indiscernible] need turn X our development the study expected activities. funding total to will current the With or is cash cash additional capital XXXX. support will that with excludes runway Julian current first based of operation of on half expect I the any is business position and clinical back

Julian Adams

GDA-XXX, by to that year, of enable could bring our X side patients. omidubicel. is cell cell regulatory With our study to an this in therapy. many bone FDA aspiration Phase Thanks, CAR-T and to the the Europe. currently for in time associated approved therapy the effects is aspiration for time We of important commonly patient enrollment and subsequently is filings the develop end with in to look marrow Shai. Omidubicel, completing off-shelf forward exciting reporting therapy without the first data an This and our transplantation cell U.S. cryopreserved therapy

next We clinical enable manufacturing activities year. are to planning and of study working multicenter This multi-dose of including GDA-XXX on cryopreserved the our study several will Phase initiation X/X a products.

these moving programs place have We and team committed progress forward throughout strong year. look on provide the in to update a an to forward our

open Now for call questions. we the will

Operator

Instructions]. [Operator

Markets. go from is ahead. of Our Renza first response Please RBC Gregory Capital

Gregory Renza

start I pivotal. with just to want omidubicel the

some mentioned good online. coming You've enrollment centers

your historical heard I just you're good to on, traction XX what comments think challenges perhaps good get your I doing and barriers to enrollments with those get overcome certainly centers, want in mention to of uptake. actually

Ronit Simantov

Randomized enroll and bone few transplantation difficult. trials, with to them, marrow in it's years difficult struggled been also have quite a There for enrollment. past have the [indiscernible] general are and been in

of helpful our aware and transplanters recognize the move think we're we're working transplant interaction investigators important engage and and forward as PI to actually So staff. that. have community is gone to the out a the with and that. complete. is it's one really and and and study that know sites emphasize that they on closely this their I with we that doing to with this They the And going very What do engagement one field is said with

anticipate do timelines the we patient in enrollment we that completing the So stated

Gregory Renza

many how up about would you And expect centers to to? get

Ronit Simantov

We're to end the the XX X open looking another study. of centers by to

Gregory Renza

among centers, team across the fact more settings? Great, of I'm I how in thoughts standardization broadly, the practices Julian and the solving the absence logistical market thanks. centers, general, to medical and fitting in may, one And cord variability just that see you your NiCord among that more blood of there, perhaps just schematic in on Thanks. for if for just curious maybe those perhaps research

Julian Adams

our the will a there be actually FDA replace and from of this will transplantation. the be ever transplantation establish controlled sites. that manufactured will cord study a care think, approval, marrow is if I product this positive, field will standardized, bone quality approved come with Hopefully, it's manufacturing question, the of blood also and it first new product we will a FDA standard in Well,

conditioned, for we've allowed really transplant the way that patients [indiscernible] affect that allowing our standardized management from of move patients the to trial. transplant or a think and I the design site field graph are So doesn't This site does forward. vary does for of the in

Operator

you. Thank

go is Needham Company. Your from & of Messer Chad response ahead. next Please

Unidentified Analyst

This [ph] Chad. is for Galon

the potential festive this maybe Thank is you're a of bit and little you then question study I looking to early a about but is GDA-XXX next So a starting know about little discuss could patients bit only considering you. year, this kind do strategy? study what a market

Julian Adams

begin. Let me

would So anticipating enable a a multi-dose that we're multicentered, approach. which product cryopreserved

designed ad we haven't make study yet the We final really and board. comment will likely an have

So that. let will I Ronit on expand

Ronit Simantov

know, focus our treat. Yes, study, population as patient you and expand with I we we will appropriate find the think patients first on will lymphoma to non-Hodgkins

study opening with will you order get specifically. for news on investigators We'll more more study. to We that design to as closer the engage in up we that have

Julian Adams

think to I we've importantly, study. us this that's signal for seen enough that a strong compels planning start

responses patient exciting in population, for cell a complete witnessing is the file very time But therapies, able heavily sign. in this a lead As me you know, there's to before IND. being long pretreated

Operator

you. Thank

response Markets. of go Luchini Capital Please Matthew is ahead. from Your BMO next

Unidentified Analyst

for This on is Matthew. Stephen

that So a for previously, it omidubicel was maybe partner expansion. reported for looking ex-US

there's steps that now for forward at in could for still that number an of a preparation option confirm partner? been the of looking omidubicel commercialization being that's potential any you and looked So

Julian Adams

optimize high level. partnering. business, includes which let So a at We're to constantly our comment looking me

readiness, of study secure that middle to prior unlikely commercial do I'd and Europe. a a both the data, file to on in and such it's like the we quite to Tom, we're comment ask since time, would intend because but this at However, U.S. Phase to partnership X in our we

Thomas Klima

U.S. time, we're in file and time same MAA all simultaneous partnership by as launch the for going out planning to options Obviously, not the this BLA said, about rule be also time. the so we're obviously Julian the certainly in at ourselves which could the launch as we're but to same at and a Europe planning to potential evaluating

will either be planning alone. for we to simultaneously if and launch So we're option go ready

Julian Adams

amplify makes of attractive just the It the if only licensure And filing that. just more secure we Europe. it on and adds It any to partner. do for I value in would the program

be better. a partnership anything alone the so ruling economics that we will we it more out we may in we're do, Europe, out. should turn downstream So the the it want to seek and not go

Operator

[Operator Instructions].

Oppenheimer. from go Your Breidenbach next response ahead. of is Please Mark

Unidentified Analyst

This later in terms is this the Matt or patients it's [ph] GDA-XXX prior treated the early, you some update on provide additional for of to I able us Mark. know of from with but to the are dataset? extended extent follow up year, ideas

Ronit Simantov

end who've provide have on the to up at will enrolled patients on intend the and update follow been and certainly do extended We we of reported year in the an already the can't we will that the to comment do that be number we that enroll patients continue up study. included on exact in study. but in say the can We patients follow the of

Unidentified Analyst

maybe then GDA-XXX. another and Okay, follow up on

this you wondering escalation looking were decision cells that derived capabilities played the you're now cryopreservation alternative the have blood dose, you of limits but we're that a reach and cord I from whether whether wondering at a if to related you're for manufacturing such also the third sources role as future? may know the we follow and NK starting as then up, into So upper considering you're are to stop in

Julian Adams

has you two let of a So, me that XXX scaled our which up manufacturing us been remind current period in billion cells manufacture to weeks. to allows process XX

the highest dose. So protocol our to designed that be

the product allow to are the do we to working multi-dose NTV study. NTV cryopreserved will dose preparing third a us or and As the this we consider as a

number sufficient of haven't schedule it'll we're potent to but NK allow the yet, schedule us a giving cells. designed where We explore

repeat I this Forgive your of last question me it? -- was you that part could there

Unidentified Analyst

derived just as considering Yes, whether sources alternative cord wondering you're was such NK? I

Julian Adams

is [ph] pleased all We cord cells. normal from very NK the that achieved don't apheresis need we're with to access believe we healthy donors. blood No,

the throughout Minnesota. a very We that the and using been in robust process study year have we've

Operator

There to are further over Julian no turn questions Adams to you. Thank would time. like at the call I this back

Julian Adams

Thank today. joining on everyone the us for call you

bring therapies We are to as cell progress. advanced forward limited options. continuing to providing our treatment updates to to hard work look programs additional with We patients

Gamida Cell (GMDAQ) 12 May 192019 Q1 Earnings call transcript