Gamida Cell (GMDAQ) 15 Nov 212021 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's Conference Call for Third Quarter 2021 Financial Results. My name is Henry and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request.

Now I would now like to introduce your host for today's conference, Mr. Officer. Business Chief Hamermesh, Josh Sir, please ahead. go Joshua Thank you, Henry, everyone. morning, good and Hamermesh call, will for which on to during Welcome today's we of and our quarter the review provide financial third results the XXXX. company update an this our results summarizing which available and press at website company, financial on the we our a across www.gamidacell.com. Earlier morning, is release issued progress

Shai Michele Quality Here prepared Lankry, Chief Chief Ronit Simantov Officer; Adams, Chief with Executive and and Officer me on Financial join following Regulatory Officer Medical Chief our the Korfin, Officer; additionally, call Commercial our our Operating today session Q&A Officer; Officer are Julian Uppal, for Chief Chief remarks. Jas will and

the forward-looking potentially reported and candidates, anticipated During commercial the trials initiation omidubicel timing cash future about omidubicel product of our plans, for from planning regarding our of activities progress our used to submission including to and of filings, this therapeutic runway. may commercialization curative expectations and projected be of the the the the for of potential our or call, and make clinical expectations operating FDA, data efforts, statements including cash we and regulatory BLA and in of life-saving respect

to endeavor developments a and human effective product around as and of inherent for thereof, and today not progress technical Risk as other time commercializing and XX-F may the expansion from well results operations, annual the the considerations candidates These I'd on product our of And views may that as to of future, report that result of business differ described most we factors, clinical forward-looking the Form information, otherwise. over Our turn and as today, as actual including recent scientific, only a impact scope, SEC represent to filings we a clinical, and safe new you and what and in from update of our due and now the whether time. with we the building statements materially therapeutics Factors number project section make like to them the such important or the are our in our impact of we cost of caution of COVID-XX the regulatory Julian. those those in trials call in process events on that developing use future

cell patients. and advance continue for Thank to quarter we everyone this joining This as of Gamida you, thanks for our us to morning. was cancer an therapies Cell to potentially curative mission Josh, bringing important

at are are cell that multiple inflection the in disorders. research offer two serious programs the clinical with patients cell am crucial NAM our see I potential enabled hematologic of point for We clinical programs; a therapy field is blood therapy, starting for stage malignancies of we the benefit with proud development where Gamida and Cell at this and forefront that omidubicel advanced to GDA-XXX.

multiple -- also developments major about recently NAM-enabled international and cell generically data quarter. pipeline and NK excited meetings constructs expanded are we medical this our pipeline major therapy modified cell sharing on We of our new at

positive robust an the be stem phase update benefit to phase to batches at clinical three Cell requested facility We in that analysis had efficacy, the potential the Gamida therapy transplant. sites of for for the strong produced first owned program demonstrating a pre-BLA to FDA the provide an start cell which designation analytical that therapy results, a of today's at need omidubicel hematopoietic on is body generated with a breakthrough evidence, manufacturing Cell's Let during and important bone comparability the three demonstrate marrow wholly lead transplant. data Omidubicel me of in FDA has manufacturing which the to by Israel recently revised supported Gamida study. patients meeting were call commercial approved omidubicel, our cell including

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our platform NK dependent produced cellular sponsored have promise and NK -- research our NK high in have technology for and therapy. to very edge we GDA-XXX that defense of direct a the conducted which lead immunity both for NAM-enabled it NK NAM patients. obviate functionality, that leverages remarkable cytotoxicity be killing are diffused lymphoma seen body's and innate a front the responses pipeline, the donor the antibody cell to follicular durable has tremendous in product treating B-cell lymphoma. cell where GDA-XXX truly is their at our and results being emerging extremely of field study, immune cells most or exciting is in of cryopreserved ADCC. cells candidate properties the expansion cell cutting large in shelf matching, in providing NK Moving at can the to investigator forefront cancer. phase the requirement line one have pipeline proprietary properties to enhance The tumor for the of off privileged cells first advanced NK

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this mission. important Our NAM-enabled hold my or turn tumors and field. for conclude look both that, Office. for it's And our to patients want remarks to solid NK our important our expressing Their the call tremendous I very and employees us product Ronit we advancing candidates we by forward my to promise and brought are have hematologic driving continued to dedication Simantov introductory focus I work today. in gratitude forward cancers hard and their work our on Medical will over with determination to where Chief

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presented line. or mechanism function The genes metabolites and of move next insights NAM also as are analyze we SU the action These cell to and abilities NK compared therapies NAM important ABCC, of interactions biological the we that artificial is held development from be the much we key looking that very in-vivo coming and used into data presentations were to give which increased phase NK NK of as to cells illustrated cell We of us enabled the without which to expansion, into network relevant with cells. XXth Meeting, differential also expanding expanded data clinical have associated NK cell where NAM with the to enabled will the forward ASH December enhanced XXth. We're up anti-tumor NAM. GDAXXX of pipe GDA-XXX at enabled data the cytotoxicity, in homing the and express NK

and healthcare in For well on with as utilization. have an with long-term omidubicel as hospital one on presentation immune omidubicel, we poster one presentations, two and data oral patient treated will follow resource reconstitution

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sustained hematopoietic care with had a intensive analysis Taking term immune Additionally, associated consultant and patients with clinical together, recovery the of function with and omidubicel hospitalization, visits, an treated XX In durations of of unit over time, shorter of procedures patients significantly treated omidubicel transfusions. hematologic outcomes rapid omidubicel. and marrow long recovery. bone with data further showed lasting strong evidence patients more period these year benefit provide malignancies

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investigators preparing Regarding with on study patients of multi activities and with program initiation the with ongoing. lymphoma, leaders for non-Hodgkin sensor colleagues GDA-XXX, in team the are and clinical operational thought meetings my our in

our to are continue patients among now patients Michelle? turn high is in after Operating study GDA-XXX. experts our active enroll over there a with more who enthusiastic beginning omidubicel. about Chief Investigators need Korfin, for Chief about and previous from have and disease the We to to Officer lymphoma I'll opportunity commercial call hear unmet Officer, this treating will with patients Commercial talk who Michele that treatment.

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

XX, compared As million XX of XXXX, year. was last of $XXX.X September position of million December cash $XXX.X as to our total

updated program, of updating year. of increase guidance. the expenses $X.X activities. cash capabilities million mainly we was we and due this expenditures that expenses quarter million $XX.X million manufacturing scientific our commercial to $XX.X talent. forward, actively the period As were to in readiness timing our progress Commercial compared going the the The BLA to omidubicel same was used total the financial activities, far million financial previous compared for for The increase cash for bordering the can previous XXXX. quarter run the commercial with reassessing for last submission same advancements mainly the financial are will I in to the our year GDA-XXX period $X omidubicel guidance development and to due be as expected rate Research and and omidubicel readiness attributed share were and including and

year. non-cash loss providing period to FDA for able forward loss forward are for same of for General recent revaluation to the we resulting I period income were the year. due to the income feedback, With $X.X $X.X the that, The XXXX. over $X.X following update last expenses the $X.X million on as Going million million are and increase million convertible expenses. the in will readiness of Julian. to to we compared of so. our same was the reassessing the in same hiring million primarily back quarter expenditures. interest position our administrative call rents turn compared for expenses for due mainly was offset quarter XXXX, financial $XX.X from of was commercial note support and Net do last to third increase Finance compared net million was The by key $XX.X the as professional management guidance soon look net business. We an period to quarter the to a to

our team to time half the of be Shai. BLA blood and cures our 'XX, that approval. are range and so to opportunity launched potentially cancer unique submission at hematologic for ready fulfill develop I'm omidubicel, need. proud to the of prepare our that in to in a for very approaches continue promise towards is can patients continue broad to enabled of therapies leverage mission Thanks, to first to working We're a deliver NA malignancies with platform the curative a part patients be we working disorders. cell of important we to towards across excited With

the potential a the issues their and GDA-XXX GAM initiate about are for cell to We are working with resolve clinical study. and FDA sponsored

are our genetically we updates. NK excited by further forward and cell providing look Lastly, modified to products

open for the will operator? up call we Now, questions,

comes [Operator Tenthoff of first instructions] Ted from question Your Piper Sandler.

line's now Your open.

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you. bringing and the that able deliver Great. be And supply to Thank would you ultimately both would ultimately manufacturing kind GDA-XXX. then Israel house, facility omidubicel to so from be with sense everything much get respect to a and much. Israeli just in and what Thanks

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Julian. you, good Thank Ted. Yeah. morning, And

So, in a yes, and of facility it approach. indicated, built art the as is Julian the modular we Israeli state

additional to ability cores as add the have needed. we So

capacity addressing the we of omidubicel because add have that we to And the facility standpoint and be have we'll we vision do NK feel demand, the that with the modular the platform. from and ability the both course. for So built confident

manufacturing. as technology NK BLA finalizing to GDA-XXX. first we're then for the the the the is with and research getting from closely The process facility commercial in team our Israel, for initiate also in requirements we've initially very for omidubicel ready manufacturing working the production our omidubicel transfer R&D team to discussed, facility of our commercial So platform readiness facility

NK both omidubicel the vision platform. the and the on was was that So for facility

Jonathan comes question from next of Your Miller Evercore.

line now open, Your is

to on then congrats progress. clear a Right? to guys. odd IND dosing. the And issue the and hold would the patient Thanks still dosing, that so me FDA It much prior hold seems

few some hold you think I some the that interactions process maybe clarity is that weeks on? that on they the in them you you what status ago would So had the day, of color since could IND thought, official quick the recall give Maybe wanted. at get And what came you on you've like to thought give analysis R&D to be the a this said relatively moment.

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you, Thank Julian.

we call The product will to lab address donor progress FDA that's confident are that the been will also resolving So made identified has eligibility. comment the FDA's for concerns. help regarding new we letter able drug qualified that been just already now and to been the soon, request progress assays FDA's per given be have its we

So can perhaps clinical share you there's been also very had. good progress a update Ronit, -- been

the the initiate so yes, to move of the the forward protocol terms needed work the we site to update operational with In are with activities continuing clinical and officially. site to clinical

that then site lifted, just So move patient to hold we the enrollment. and once is forward IMD can initiation

a from changes of at just have this pieces. view, protocol the other operational with we're making So we're that no clinical proceeding point, and we point

you line, modalities? other the that the can extrapolate we on abstract the also on we HEOR can And and Ronit, what since and question comment have you to

absolutely. Yeah,

HEOR analyses. we So, doing are

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at our those and analyzed And that's be and could Ash. study be quantified presented all direct what data so from

same the of we information additional in able sources at Now that of CIBMTR the to. meetings will at context to HEOR a you omidubicel. from when other doing at date benefit update and databases Those analyses are be will additional time, presented the broader we're HEOR later about using potentially look

maybe turn to final it Michelle question Your

HEOR to Julian? regards In

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comes from next of Your Butler Securities. question JMP Jason

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part AI with learning. the take me first Let

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for Thank Julian, And cell. for the Good light and lot my going delay question. update. you on Julian thanks taking team. for GAM morning, in certainly a the omidubicel of

how certainly you far you're your Thank you portfolio, waiting affect comment omidubicel these reassessment but are, far comments as be just you. through and any you and XXX. as Just are developments planning, as with approach of, What could as overall you of mentioned inputs would spend think, how curious planning allocate totality, do if certainly resources thinking What at? to larger appreciated. for the are your Yeah. around either the looking the on and portfolio GDA-XXX to your

and of conduct track and with readdress the get foremost, future first comments to back submissions the we trials. Obviously have our FDA on and

of strong development to able you way And pre It in all lo can position. expenses not yet consider course, burdensome for capital it's OOU a we for we're further know, our dedicated still the managed. enablement back us still in, programs very going as a X are in cash we GDA in, determine a and of process X to this said, to a the it's As those. and to be it's be not have first know, in, be you X stage preclinical allocation need easily of responsible reassessing and prosecute we But the that of and still and the, cell we, towards foremost, timelines our

about think Maybe value just helpful. as for omidubicel. capturing one you last you. That's Thank one,

regions. update on far could those you if provide as or regulatory advancements curious is as thinking an in again, or, where partnerships Just us or, your Thanks

some glad, this to studied we turn for it provide over have actually I'm let me ex-US to and Michelle territories insights. question, because the

very Yeah, you much. no, thank

in of parts and a very Asia Western Europe commercial specifically omidubicel So encouraging in Japan. acts opportunity as

cord Japan do improve You am for the all graft know, a of in see transplant. omidubicel across particular, their outcomes an opportunity to about we blood third see you as utilizing patients sources for although

Japanese very cord for omidubicel, data when saw were very, So encouraged. head-to-head they the physicians versus

and move Japan, Europe our what's had allowing outside the we the and takeaway Chief and and in dialogue And of to have how the jazz of appropriate team our we I omidubicel with her think now there. But EMA opportunity us. with is forward is team patients to good we probably very just encouraging already. Josh to access key Business do the, opportunity patients Western have continue see around as closely way to Hammerman both partner in for access Officer get on others So an the terms

understand on advance patients approvals. continuing look of following regulatory allowing the eventually those plans we that forward So us to to to forward, outside the regulatory around omidubicel path access we

a adult little issues addressed. is us would for a that a always sites But be would file Europe just conducted population. those I three phase bridging international without we are all as laws have with I since Michelle, we think ability to to trickier the do Japan Europe that that And, are have in study. in in additional the unique Japan technical studies to and because bit there study add of an the can required

Your next Gandhi question & from Nishant Needham of Company. comes

now is Your open. line

presented showed compared Hi, SETI. with questions. you good morning. NA Thank CD potential the for The GDA at data X to NK for cultivation this X taking have there's related standard in decrease to a results question XX X expression I cells. X be our X GDA a issue a the that X? Was

Ronit to and let it well. then as me Yeah, turn begin over

CD Ronit, add? CD in see we to per proposing in variability. overcome we quite expression, decrease XX XX of to anything high terms are have variability high doses is but this the mitigate this address still CD donor of the of very you to modest First cells donor do to all, to and levels XX, kilo at in

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instructions] [Operator comes Mark question Breidenbach Next of Oppenheimer. from

Your line's now open.

for guys. thanks good And update. Hey, morning the

of submission? we we'll type VLA where separate FDA one meeting. submit Just to the me the do Dola data reasonably just a filing. a provide another you scheduled meeting without, a you, kind Thanks. with before, the with then and assume it the quick a to regard that situation can you without the from before is need Or and have Can analysis B be

ask, think our perspective that. to And very about we me sorry, talk let a on have approach. Jas Yeah, filing good I

you, Thank Julian.

discuss meeting the to thereafter. So yes, and type B analytical have data requested we a comparability

us FDA just IND for to have We type an are VLA guided meeting not than a submit meeting B anticipating B the an a we to pre additional to that type amendment need outcome. equivalent particular rather that

further I I'm like would question. No sorry, Julian to call turn the to back Adams.

a is Gamida to us really on who Cell. today. joined thank time for pivotal the want everyone I It call

I I the They're hard and are dedicated hardworking extremely issues, and addressable in for whole working express Over their FDA Cell had attend nature doubt. we Gamida is and and We have the very that, gratitude technical to beyond think family enough very dedication. team and that. to to can't no

beneficial want knowledge hope for and in have families you also your will I who prove that participated their this benefit donated extremely and forward. And I have patients to going the thank really our to medical thank the medical studies all morning. community clinical our and to Additionally, of attention

This Thank joining. concludes conference. for everyone today's you