Gamida Cell (GMDAQ) 11 Aug 192019 Q2 Earnings call transcript

Welcome to today's call during which we will provide an update on the company and review our financial results for the Second 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 and Tracey Lodie, Chief Scientific Officer.

Following our remarks we will open 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.

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

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

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

we for hematologic diseases Thank cancers everyone to cell taking you, serious us time patients and Thanks transforming rare of development the for therapies. to the treatment focused with are on Gamida blood landscape this generation next Jaron. Cell to join morning. At

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success. Sanofi Syros Hematology, Tracey Centre Tracey Boston and been appointed immunology worked skills team a for and at Israel and future ensure Oncology. leadership Beth a Last has obtained we at advancing to Medical month, Lodie, As as and Chief Department our Officer. postdoctoral and abilities instrumental She have through transplant School, required programs of and that at Medical have strengthened in advanced, fellowship Genzyme several the of has BlueRock, pathology area Deaconess we regulatory in our development completed has the company the in University further autoimmunity. PhD in approval Scientific we previously the the

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with of half Minnesota University a reported in Patient myeloma. to response additional the and is the of also We patient enrollment second be a multiple we data in in complete at expect this ongoing study presented XXXX.

facing life anticipate with to with To non-Hodgkins who As move our compel therapies pregnancies. have GDA-XXX both Phase treatment lymphoma cell Julian options us plans clinical study a with clinical these we are patients important GDA-XXX, two initiating next and multi-dose multicenter we with made X/X our omidubicel year. wrap of advances patients mentioned in to to potential updates, provide important clinical development up forward the threatening data and

have to review financial important you our turn Shai over and updated to results. clinical progress. to We call will milestones With that, keeping the I our forward look ahead I on

Thank you, Ronit. everyone. morning Good

and I advancements on As you This the progress year. to made our XXXX. heard results this with will this Ronit quarter so we financial we of are review continued have of course the and pleased the are far from over Julian morning, year, build for second the

release half in our first filings. can our press in find year You results SEC and the the the for of

as non-cash securities due this our expenses General available due of cash, second million. XXXX and Innovation million XX, December second and last an income XXXX quarter from as a Development was in second Finance million compared XXXX was services grants million quarter expenses in XXXX. The company. higher for increase GDA-XXX same the following were $XX.X in As compared increase the to XXXX. the a was compared to to were and increase a we offered grand June U.S. net in of cash the of the $X.X by being non-cash $XX.X a compared of the had period non-cash expenses of by Net administrative million. to million, were of XXXX which income the period $XX.X same same related devaluation compared in in a million cash The for primarily quarter the advancement second Israel public related for quarter Innovation of professional the of $XX.X million, of to XXXX. headquarters devaluation XXth due given of total in $X.X traded hiring June in to expenses Authority. XXXX the position mainly Israel net but to in recent XXXX. net to both finance proceeds Authority million were as $X.X million second $XX.X were R&D due loss the income year for resulting liability. were second XX, gross well expenses the of million the expenses the from with $X increase from to $X aggregate period $X.X omidubicel cash increase XXXX, offset was the year period establishing excludes quarter and $X.X in of publicly and associated [indiscernible] of and for quarter offering and Research sale million The net the to equivalents to same

to from expect $XX range to ongoing use to clinical company's continue cash We for operating anticipated to $XX XXXX in million advance expenditures the reflecting million programs. activities

plans on With that our to will funding updating of the our runway cash into our XXXX. that call our support recent excludes activities. This operational turn development over the runway expected activities financing now based quarter are Julian. will cash business position operating current or current cash guidance total the any ongoing fourth additional guidance I and We and is following back

opportunity FDA important first Cell. the bring for This year for Gamida Shai. have transplantation an approved the With to bone patients. omidubicel marrow executional Thanks, cell is to therapy we

out. with We a GDA-XXX are Phase to of year. non-Hodgkins a of generation enable study advancing forward the NK GDA-XXX activities multicenter X our activities to forefront next immunotherapy. enable readiness working read we're study while a at next several as With key moving We're advance lymphoma working cells to in hard launch data on

in forward year. the advance a to We progress in throughout and providing place team to updates our have programs these on look committed strong

will for call we Now open questions. Operator? the

[Operator Instructions].

Your first Gregory line of RBC question Capital the Markets. Renza, comes from

Your line is open.

on please program, activities wanted on omidubicel you your have of remarks. some touched that the in trial may just clinical the Just to prepared with touch just start the around and

facilities with but U.S. about facility, there Thanks. serving to just Just agreement Lonza on mentioned your the specific little European one, view certainly the regions and you looking with going stand could manufacturing on number expectations also at of a supply Israeli of and then the deeper the you you that -- specific the those you you're just a how the the serve little where seeing touched bit regions?

years, relationship for Netherlands site. and We've would terms Lonza's about had we modern the looked a have plants looked we as a facility. commercial with various single very a and XX in trial We're launch, Lonza situated ongoing not towards now an supply we needed for suited we and as as We had of a and clinical our uninterrupted fruitful supply potential and there's needs, supplier. in brand that and well-heeled the us have new very both well that satisfied throughout plant

board for redundancy. an for agreed we've and the business So continuity and internally with

also all built our building control are patients. Israel, where we will chain our own have to and redundancy better We serve facility in have into supply

[indiscernible] the you process where types will stand and a Great. of of that, but the could word how building what then planning, that just out plan proposition readout. value this engaging you of beyond And with provided if you pivotal have the you with with just the information on them as the that to and so play proceed already the trial concept beyond

ask this spearheading is effort. will comment Tom, since our Commercial I Officer he Chief to

right payers key in the of the in United engaging process of are We the all States. with middle the

calls I and study patients on I've in that for commercial expect design think characteristics study. enrolled the be previous this mentioned predominantly of payer given omidubicel the mix the to previously we

working what X payers will closely Phase been look the we've educate So to or on looks like like. data

see the secure Phase is will best working like pretty reimbursement study very for path have clear will reimbursement. that looks way, getting that along data the the looks and education straightforward. to and for a X/X Phase them ultimately feedback been So with the around It require path It's to what like we omidubicel. in [indiscernible] X they partnership but we're positive need what

queue. that's me I'll to in the And just or hop And just more question one and regards for GDA-XXX XXX back in rather.

trial and with What effort how the a Thank would the and for cryopreservation, taken larger need to Just like? underway for formulation cryo with year. the much. and next curious the as of you at expanding what where are timeline look look course, stand be factor very you gating a you steps

that Yes, we to let cryopreserved shelf, so comment on me the to that necessary a cryopreservation. if multi-centers. have off be want It's will product engage

of one manufactured do being as in we current study. fresh and have for but that's multicentered Our fine cells GDA-XXX to is a Minnesota course, center ambition

to it's the So It but that's And on scientific. of work have experience omidubicel. lock is needed and pre-IND progress lab, With including the closer as next say launch artful year. number as turn provide one. which successfully it in as do learned the GMP process, all very IND. easy down I I'll expect the going years eventually, the years we final is cryopreservation, and and to and with color is into sometime we have we format our to well would in this to timing get the to we very this really the we how based to not later do filing year. a aim the to do need what's well more toxicology, activities cryopreserve, just we done, that will that trial

Your line Needham & next Messer Company. of the question comes Chad of from

Your line open. is

single calling the look dose you're dosing little Was it only Just trial that ongoing what more is going is GDA-XXX, a a multi-dose, to multi-dose you're trial. on if like? and

couple bonus correct. it days, Yes a essentially is is infusion current dose. but that’s over giving a The it essentially as split trial a of

regimen it we four of used have the and cryopreserve up about condition have dose [indiscernible] dose-rangings to dose or is we we some schedule give on formulation which to that the patients do clear in patient. is some with depletion based a that weeks, and these the finding couple per doses So ability do what intensify to could three

So that's something we're in exploring. interested

what and are into term long to your plans solid Great, go potentially tumors?

very due on doing data, at of and in pretty the expression product as we cell antibodies we those it GDA-XXX speak, a we're on GDA-XXX. that that So high as meetings. cells, fit with we our have to we're NK available quickly looking of at We're make we emboldened will lines, CD-XX scientific various the data serving have very combination

wondering Okay. data trial Phase so Aplastic just thoughts from one this X, that. very or stuff, quick mean, would the real Very and Early phase your that fileable? is a on that Anemia, days. just a I patient exciting safety on all XX of is maybe second small indication potentially have the this you

looking omidubicel. right. You're is with single and treated Aplastic single patients a being this Anemia unit is disease cohort rare dose at

second started label is cohort potentially at it's forward single most to efficient on you results we've is forward enroll today, going arm our our that patients, think something plan rare certainly we see those once to to a a path mentioned, regulators with do results that and we path and pact do open that and we the And towards. know discuss we would look carefully study, a look diseases of find As plan number a for to is that's with we once approval. the

next of from Your question comes the of Briedenbach Oppenheimer. Mark line

Your open. line is

just half mortality more related on include of first 'XX? bit I our This taking engraftment extended you the for or include it's and omidubicel premature packaging data but top data guide for the a guys expect other Matt of treatment are up to follow Should on we Mark. you can or the how might thinking Julian, also questions. Thanks is in know outcome? line

I as is think to line said provide the related we our endpoint. which primary top goal is data to

fair. Okay, that's

There for required these extensive up follow patients. is more

year. the occur lock final the database in So data and will later

BLA the well. as preparing are we As

to since etcetera? then year? lymphoma? patients later you remind could has also expect nature treated I protocol to if of should the that wondering set been us Okay, the for clarity. got update mean, additional on data, also more we're we follow if And TCT this enrollment And really the amended you trial GDA-XXX expectations it. up, Thanks for restrict can non-Hodgkins the

longer So enough want about the sponsoring lymphoma the moving forward data Minnesota and they this both additional is study follow at point to in we've expect is already in this patients provide presented up at who lymphoma. and additional at well from with confident and the seen we complete incremental study patient have some of finding were University site and study But a and this as already to be myeloma accrued the to dose TCT. study do non-Hodgkins safety patients that we as

In addition, continued study. we the enroll myeloma us moving the the but of really multiple seen in cohort cohort study the the next far cohort will continue in to have out, we originally or as set we've to forward data that terms the lymphoma has so complete

[Operator Instructions].

Your comes next line & from [indiscernible] question of the of Company. Needham

open. is line Your

formulation frozen Just this study. one the this batch about a multiple a will or there'll will GDA-XXX the next single for study? considering be Will be for from batches

will it derived get [indiscernible] an patient. each from GDA-XXX be sorry. Currently a will donor, multiple patient batches,

just facilities your All on in additional any Israel. tax developing question there Are in right. a facility the And a of bit for Israel? benefits

We zone in tax favorable in of happen considerations. yes, one and that be was the a to Israel

this to Julian back Adams. further showing I'm at to would like time. no questions now the turn conference I

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

updates patients options. treatment During to to look bring hard advance providing our the we to have as the throughout year. therapies seek with quarter pipeline cell We worked advanced limited we additional to very forward