Gamida Cell (GMDAQ) 11 Aug 212021 Q2 Earnings call transcript

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

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

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

Chief our Officer be Here Financial Ronit today Officer; call Executive with prepared Adams, Michele Operating Officer; will a Chief Julian Chief and on our following and remarks. Officer; Medical also me session Officer. There Chief Simantov are Commercial Q&A Shai Korfin, Lankry, Chief

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

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

Thank us for you, productive Josh, thanks This quarter Cell. this was for joining Gamida and to a everyone morning.

first stem execute for allogeneic to need cancer omidubicel of continue in We on stem plan launch the cell to patients therapy, a our cell transplant.

based addition, accelerated natural And with new follicular NAM preliminary enabled to excited we therapy expansion very plans on cell enabled cell killer lymphoma large pipeline program blood and modified candidates cancers. cells -- cell omidubicel, cell therapies. NK are I'll patients advanced a our with into are in work, our targeting cancers start turning curative stem enabled life-saving the NAM a forefront with In promising NK NAM B-cell genetically for are our we develop GDA-XXX we committed of for or who need have product the are of most potentially treatment of a about transplant. diffuse at with unique NK to our lymphoma. patients studies, Patients and our X

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continue execute of XXXX, action this as to agency company a to year, of subject BLA Omidubicel FDA has therapy the an in we a Michele the transplants. end quarter. stem first in toward prepare the omidubicel commercial in pre-BLA fourth becoming potential our submission with plan be on for the will meeting the the readiness to launch for cell call. by to We provide on for update cell approved later our

requirement potential next-generation the defense innate tremendous properties, to providing antibodies We privileged immunotherapy. matching. that cells HLA Moving have obviate cells pipeline. our best-in-class in NK NK first-line immune which NK believe immunity. as of for hold a also They

we healthy allogeneic any produce off-the-shelf natural apheresis can an technology killer patients. NAM proprietary provide cancer that apply adult to Given for treatment a cell cryopreserved which donor our and unit, from expand

enabled expression the or combination with allows NAM ADCC. CDXX, several NK including important Our enhanced receptor to cell surface cells cytotoxicity for tumors target antibody-dependent of markers, cellular display through RIII Fc-gamma the antibodies, which high antibodies monoclonal

for leads adaptive enhanced tumor results durable killing and in clinical increases which specific antibodies Importantly, ADCC, in The for supporting combination retention and secretion in treatment cytotoxicity also NAM in cells. tissues. in both parallel cells for to cell therapeutic responses. increased efficient cytokines these immune GDA-XXX and increased of expression, L GDA-XXX's selected antibodies activation homing of The of selected were malignancies. NK potency more both host CDXXL killing vivo, in inflammatory lymphoid with NAM of combination increases with Furthermore, with an vivo of vitro activities

potential studies diffuse level the advancing clinical next patients remarkable as B-cell for lymphomas. We large NK GDA-XXX, demonstrated with the development, second of cells our a follicular in which has in candidate and to treatment power are with results preliminary

to Ronit genetically on the to detail more we variants exciting our proprietary to on NAM and cells batches technologies. submit quarter of we track employees CRISPR/CasX through turn R&D I/II power shortly. forward with of this biology modified believe call to this update more proud of my Today, over to continued to team include I our great in further thanking progress IND -- will work. bringing cryopreserved therapies our study this the We And their to by the GDA-XXX combined vision the providing an GMP dedication a will Phase that, with want we mission holds therapies completed made technology end NK and Ronit. for really expanding and year. formulation new of give the And look and introductory now our expansion, multicentered the to announced at the this further patients. both our Day the to and I technology, conclude are our have our support I later using of curative hard remarks the that year. NK development of and reach CAR expertise promise NK with that with I'm extremely of has are growth an by a for in pipeline our detailed

expansion, research key very to we've malignancies targets this the genetic NK on researchers academic of these in detail data cells involve intended NAM important persistence newly will technology both patients. encouraging we leverage pipeline against improving which cells, represents I'm [indiscernible] excited GDA-XXX and Cell We're Julian. more morning. conducting with that based against and for and we've confident on in the programs and new NK announced with progress lymphoma. direct for our These been at patients pipeline clinical modifications provide you, Thank announced potential to our for expansion and here NK the to solid therapies enhancing hematologic collaboration targeting with development Gamida This tumors. cancer cytotoxicity demonstrated in

activity are believe enhanced antitumor with in IL-XX. protein SHX candidates Knockout NK coupled CISH the insertion CISH effects. multiple equipped dilution threshold. and IL-XX persistence containing preclinical designed product cells membrane-bound in NK is inducible tumor cytokines CISH across of In has or cytokine enhanced we've and improved CISH of GDA-XXX, interleukin-XX pro-inflammatory demonstrated the membrane-bound lowering regulator activation cell. sensitivity We potency IL-XX include potential CRISPR/CasX target to by or and types. with IL-XX increases concomitant elevation membrane-bound for that NK with a a NK new IL-XX cells studies, of using and Our signaling the of cytotoxic

of which a tumor we is engineered to the undisclosed survival today, development solid target an announced Additionally, in genetically designed GDA-XXX, enhance cell NK towards microenvironment.

we GDA-XXX application range GDA-XXX, solid broad believe has tumors. potential that with of a across As

widely and cytotoxicity were designed candidate to in pipeline NK gastric cells is used multiple These enhance potential trastuzumab. our receptor pipeline optimizing target out tumors an enhanced HERX, humanized allogeneic to strong biological and target over single with the or antibody expressing such NK engineered intracellular GDA-XXX, in development and to constructs preclinical variable CAR targeting. cancer, to is fourth in as has CAR studies, are chimeric myeloma. focused a to cell, The domain. of is increase several our lung, on cancers. candidate enhance showing chain myeloma in in multiple the antigen that target The NK further validated of established a potency. monoclonal NK a is against ovarian, The was rationale the myeloma. based GDA-XXX, of fragment designed This homing candidate is on CAR And selected CAR the GDA-XXX primarily signaling CDXX immunotherapeutic is There augmentation which bladder for third breast NK HERX-positive development activity solid tumors.

launch side To to to editing increased CDXX protein turn research forefront studies. to myeloma our cell with represents cells omidubicel. at Chief on advance overcome of by is of to our in Officer, in we Operating treatment of CAR CAR Korfin, approach promising However, anti enhance this therapy. NK and of ACD the positive will CRISPR/CasX CDXX Commercial we and barrier development preclinical I'll believe CDXX have expansion genome expression the talk NK the powerful cells more We targeting CDXX killing the a proud expression this new be NK NK a this which for technology. disrupt targeting and about refractory call of readiness combine are to Michele to designed we demonstrated CDXX, cells, Officer to very applied our We now that during cancers, Chief NK Michel? are over NK. XX who the anticipated cells,

Today, good everyone. our launch our morning, will I and on and review activities. Ronit, commercial you, manufacturing readiness progress Thank

we need stem cell advance breakthrough omidubicel our in therapy, continue to As for an of transplant. patients allogeneic

support and XXXX. a working to fourth year, the omidubicel of in are and activities towards we are for mentioned, launch submission Julian BLA planning quarter potential As in our U.S. underway launch manufacturing this

This quarter, owned Israel both in facilities the make Cell activities manufacturing preparing Lonza. manufacturing at continued at both we for readiness. important CMC commercial and progressed qualification Gamida to our facility progress

made We have validation, significant analytical method analytical manufacturing. comparability and clinical advancements in

track BLA CMC submission. the qualification on We to finalize for are requirements the

U.S. there that Melnikov deep our and experience Operations. broad a addition, Vice provide President, Global year manufacturing significant hiring opportunity very the expertise readiness. We Vladimir's with XX,XXX malignancies are commercial over transplant. are as believe able we Unfortunately, who hematologic and approximately patients make our of consider a with Senior omidubicel. and about key to is excited patients In marrow advance per there In alone, it Vladimir we to as transplant variety Manufacturing XX,XXX for only bone are reasons. a

and International Research strategy the be a reach research for with summarized on market patients We research Center to in commercial and can research opportunity need. launch in CIBMTR well-informed omidubicel has have enabled market key X us our transplanters. collaboration done assess for categories. independent unmet Based Marrow to insights, develop or the the and these to Transplant fully extensive Blood This firms

improving donors. clinical and access stringent important eligible for is is patients can patients omidubicel. that for One has area sources who criteria addressed unmet This compared from outcomes-based tend also for graft First to with it are have by time who transplant a matching omidubicel related match. for patients, match is suitable sources for especially And the a on cannot current donor. of challenging more particularly descent those specific donor advantage of that finding be non-Caucasian needs unrelated match or find a as less increasing to

could trial, timely to for in In U.S. of high-risk omidubicel believe relapse. omidubicel this omidubicel risk strategy. source at of that several causing fact, a III patients patients suitable for are of launch the we levels for anxiety will approval, enrolled need or cell stem therapy transplant are need and patients FDA high strong who uncertainty in XX% an need graft marrow a approved, population. transplant and of the for important an otherwise source focused search suitable graft and illustrating donor option would attractive be who matched believe If a we bone the a option Phase important in over on we patient months, a non-Caucasian, provide undergo the patients for were in for developing a will great a take Upon allogeneic also in

hired our the team augment a commercial capabilities experienced of have in very the and U.S. leadership to we continue Specifically, team.

value to payers omidubicel has have of continue encouraging. we active feedback with and physicians the Additionally, and highly proposition on dialogue been

the of to progress, Specifically, decrease the a payers other are graft as time compared to faster undergoing a assist U.S., in which omidubicel. sources. patients, be to transplant important development patients teams neutrophil less literature of This transplant. journey an and the engraftment, preparation hospitalizations Gamida of will throughout by decreased each published potential In for for encouraged in patient's Cell for potential the to other for continues support no is with caregivers omidubicel source program disease graft-versus-host like approval infections, and

support the supporting on team management transplant include omidubicel. the Cell We have patients team caregivers that will the at of leadership throughout Assist Gamida be their The team case and the experienced will that of with Assist cell patients, and will journey focused on focused have number the an ensuring Cell each Assist will hired access process. providing key hospital Gamida to roles. step team a patient Gamida be

of roles most patient a is FDA's that will identity, of Assist the start our process. the will Gamida the important Cell entire the follow of requirements. chain with is identifier identity One which compliance patient through unique chain

bone clinical matters most, payers patients will committed transplant and positive potential omidubicel, successful to and transplant, the we in travel and what summary, and verifications for as experience Cell we hospitals access so a physicians, marrow addition, excited be on by to encouraged journey logic omidubicel In patient the In first and we provide patients. outcomes. support their assistance be the cell feedback the patients is benefit for from focus are they to are supporting the clinical Gamida could centers able or needs. to of with such and FDA-approved by data therapy to

for now call our XXXX, financial our a turn product assuring remain center and review preparations focus results. track with call to on to progressing We transplant will launch over Shai Shai? and on patient are a I launch in positive -- experience. the

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

by broadening and quarter same the million was $X.X leadership XX, with talent. of as offset $XX million among XXXX, NK quarter advancements things period omidubicel did of income an was compared year. to cash expenses including development December June of scientific for $XX.X XXXX. in same progress we year. increase loss for was compared total same year. in year. activities, to mainly omidubicel administrative position The compared period $X.X the a due million for million the The this million capabilities for commercial management expenses key activities the to compared increase primarily emerging second was of due readiness same for for increase attributed the compared GDA-XXX $X.X XXXX. $XXX.X in growth. As from note financing and net our interest warrants, higher million million to to $X includes, mainly for and million the the expenses million business the $X.X was XXst Commercial $XX.X to other XXXX experienced loss of to noncash last $X.X revaluation pipeline, million compared same our and of hiring which quarter resulting convertible quarter of million quarter the increase $X.X mainly the the period net the of commercial year. in to to from million Net Finance commercial will period expense the $XXX.X in support finance as million of were to due our $XX.X net was were team. last were The last the Share manufacturing period to expenses income The readiness Research earlier well last for position as

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

Shai. Thanks,

vision Our has hematologic patients, are disorders. curious the opportunities many excited And always for and been that ahead. define malignancies blood we

success data, lymphoma at ready to fourth to share committed create year. foundation and planning platform, data clinical on sponsored its Cell GDA-XXX we to will BLA this of before We XXXX. in this of launched the mechanism and compelling The in meetings publications heels year. XXXX the medical of in being year, accomplishments for data With Our we time we momentum more omidubicel, on are at NAM major a approval. of are the and initiate build in expect study and extraordinary the Gamida submit action peer-reviewed quarter data with to in of the clinical plan mature end a our the translational

about year. expansion progress look we more report excited NK announced you pipeline as our to today have we're Lastly, and updating this later to forward

your Now Krystal, we open questions. the for operator. will call

Instructions]. [Operator

Your from Piper first Ted the Sandler. of question from line Tenthoff comes

go Chance. the Ted just caller. next give We'll maybe let's to Krystal, another

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

the in question the manufacturing what ramp clinical both be do on anticipated specifics current we is of and pipeline. the Congrats time programs. those launch? these potential you side, this the cash time to side current Then getting of a anticipate IND these I'm the come of And team OMI Couple being talk you Secondly, to pipeline anticipate of big XXX programs, before on the things us approval? subsequent as to you more line any bit states, new you've on curve. of other And for a fill for programs is target you curious about line talking Are the OMI, contemplated all about the to have what across pipeline, maybe the the going the commercial the of that especially needing? ramp maybe market able anticipate announced. the Can just asset? runway about spending that supply is volume an initiation up? How what the of little BLA timing enormous the that mentioned from of but clarity

to commercial and question. expansion ask capacity let you respond to the Michele, the me

Absolutely.

So question timing. team in regards to your field omidubicel about and

look the So or space, approximately XX when the medical managers that therapy also We science approximately to XX make commercial centers centers is at XX range XX% focused you the team. in T personnel if look at benchmarks for and in fall transplant do the companies liaisons transplant on that XX% up specifically, in account cell their you are under U.S., that the the U.S., approximately Ronit's account know to for XX transplant. of the would core XX

do ranges on thorough, but very be we efficient field. could lower have in and actually of a the feel the footprint end we So those

So we're looking on the that mentioned. lower end of those I've ranges

the lower of science the managers to liaisons XX, commercial the end the cap range. that and So medical XX the to closer closer

was Vice have ramp-up, President hired so side, for on In terms management. of we and commercial account our Stamler, both marketing Linda the who

-- account account in the in excellent team manager of affairs up the leader hiring and management side. made bringing team the Ronit side leaders in the marketing medical is both So the her Linda already, have And and progress and strong place also. have on process we in now of timing the mapping

some team field So place. of the is the and also in hiring leadership already

has team ready in question the designed to facility the commercialization. designed not outstanding regards for manufacturing our but progress, in the When qualification for for was only a made ready as footprint. on was In Israel, really the the BLA, that's commercial modular getting getting facility. at with So requirements commercial manufacturing, Israel, also facility

our to data ability have forward upon going in at the this seeing Gat. in additional Israel encouraging we're our come facility potential Kiryat approval, modules forecast as FDA add for in So we

launch we also, know that additional facility we looks confident already very only not feel the readiness or like but long-term have for place modules. needs, for we commercial adding additional the what So for in cores

see Ronit So what on then me you stop any to I question. questions turn if just for the have there, and let and said, NK could John, I

was How And are. the what there? launches about response. -- a you any we're opportunity Do update that color market? while the different the talking BD U.S.? about No, on is talking fabulous opportunities ex guess and for to the on what I updated any commercial you we're have EU

Yes.

other So talk and EU the mentioned me markets. also market, about I let

other stem in Europe we undertaken including by and encouraged assessments Europe therapies cell have certainly need both throughout the sources, We're areas Asia. So patients other There's parts including cell other the great for the and the commercial world, for in of opportunities. also certain graft transplant Asia. world, allogeneic potential in

be launching we're omidubicel we clinical U.S., So was head-to-head to and as a we're and to The potential a could certainly in in feel very plans on strategy and do comparator. launch the it, designed focused study Asia. our in Europe execution currently our assessing very confident in path what

we the Europe. applicability in that certain parts So of recognize world, study specifically the in of do

And want general just I'll with I'm NK cash in comment the the position timing? as just do XXX, you pipeline Ronit, further on cover regard our to well. XXX. saying to

Yes, absolutely.

of So of I've year will providing those now. what And specific will this midst programs program. But not of an vivo an is the more later and Day that we we advance detail give to of that as R&D including color have prepare the outlined, timing IND We're and say in we and evidence about aspects detail studies studies. we the each the about the can preclinical right all opportunity I information, in that through in vitro IND. in are for the build

sharing more later. detail look So we to forward

for to cell of clear to including be cryopreservation repurpose raise all pipeline. see prosecute It's CRISPR/CasX additional with to will and our we've CAR I couple But able of so the an as ridges lot technologies technologies and programs. pipeline able in knowledge, our But enhance been a that these capital quickly. need our Obviously, this embarrassment expansion. we that currently, to to

So forward with to to I R&D share the seeing have in certainly you Day. what look us

Your next from Piper line question Ted from of Sandler. the comes Tenthoff

also if contemplating just you're that to my prepared all remarks Congrats donors? cells but on other be And I'm listening answer. some contemplating wondering, court? the all cell NK at of your progress. processed question umbilical favor could are wondering the are I'm you evaluating types and from from too,

you thank Ted, question. for Yes. your

the the NAM we've technology some very with In just with a obviously, good other types gamma the expanding and really attention able to has been broad NK said, been of applicability, is in cell paid fact, this preclude to it a to being had able we've is question expand T-cells, bandwidth dendritic And luck we've expand therapeutic cells, prioritization very, of potential. the doesn't That field NK lot us cell program. field. in from delta

Great. That's really exciting.

to forward clinic? and the the XXX also BLA into getting Looking

Thanks, Ted.

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

the congrats taking Thanks on for and questions progress. the

EAP an give or on omidubicel. programs. could First And the expanded any from we second the question And see submission one, you pre-BLA just on the the if then this wondering data for us BLA program meeting the will NK before year? update access

you new programs? manufacturing cryopreserved You your speak products how in clinical development? XXX. facilities? leveraging those the start the into cryopreservation you with the will integrate they for to Can plans experience Julian Or manufacturing your be for just mentioned Will your from of maybe the

EAP, then the let Ronit I'll answer the about your first So NK and to to talk question turn question. me

Absolutely.

is Lonza, program that for our as our we're -- has So and been we've to Kiryat study using method to enrolled the our order a manufacturing access that. as Gat for commercial do been and it Netherlands and and do facilities expanded currently in as able in programs, cohorts serving clinical expanded for patients both running, bridging the access open

in some or When results those publication to our those happy with that for academic and ready collaborators. that We will those all be data we study. collaboration feel And from we presentation. from mature share have

that data as submitted about meetings excited other to study potential medical the very on we also end sharing of well. are in and will our be we the available those that been hope and data Phase data So make by other further year III have

Okay.

me off-the-shelf let We cryopreserved only Jason, the forward. going program. And products intend respond use NK to about

going is both pipeline playbook then so can them, forward. manufacture and and will cells apheresis and we be our the manipulate genetically that that units So designed them cryopreserve from our

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

for This is Yinglu on Greg.

EAP. First, was follow-up for manufacturing clinical line time how expectation data that for and should collection site think the on how align I maybe a Israel? we does the for the your with wondering And think selection the pre-BLA fourth pipeline. NK one the for And about in meeting in you a and submission programs? X comparability in the quarter? multiple then across and another How you have now on that the program execution do about

the EAP? So you on again comment Ronit, would

Absolutely.

with have the investigators about sites us incredibly patients. worked before we for enrolling EAP open U.S. and So with the who in have enthusiastic are X

that we in Kiryat using the will treat facility in our have treat as we in slot to we so do them. continue patients coming And manufacturing, patients advance And forward submitting and the as to for advance towards months. the able BLA we program the Gat been to

all regards be And process the selection with data-driven. to the will NK,

the models We have looking using of number make models created to cell We're targets. sophisticated very but these a mouse programs best other unmet will and product of for will we need go selections who developing. careful product market this as commercial assessments as augment the also very, various PDX -- And informed to models that development. interesting at well are will colleagues, be assessments lines, our by for eventually

congrats the Great. on Thank you. progress. And

Bernardino of line from the from Wainwright. H. comes question next Vernon C. Your

filing its omidubicel some look regarding I to forward insight Very with progress wondering research the further and provide new and the programs. for excited your could you conducted. progress if the you this later market year was on

that the market various your research has has a whether groups the market pandemic these effect changes had researches ability cases. a particularly targeting But the on what the prompted if component surges also wondering included of was I opportunities? any strategy the Specifically, as conduct procedures, transplantation you identified in during regarding and that COVID to procedures

activities. answer Michele, let to on research invite me the market you

And of that So encouraged by we types research. research. conducted of number is different the a consistency very of the market what we're

latest research product this that profile. and study. research with study the before with the round data we III what completed had It Prior was U.S., set it data a from been XXX was clinical to targeted was we or all conducted. as in market actual of would Phase So transplanters the refer was in the over the

to, encouraged number feedback a or Now on we clinical spoke reduction and interventions transplant the also in infections. we're secondary endpoint, endpoints. the time getting were data due care the of by the were physician around reduction actual resource factors, for in They specifically hospital endpoints health the by utilization, the and of Payers to that very recognize importance and less reduction primary clinical we exploratory also data. encouraged

the So very takeaway be research encouraging. to continues from the

to So it inform not changed has the give better What our strategy. is our has and help done actually it in confidence more encouragement opportunity. and strategy us

very with we for told the during could was it a were X comes the has to we difficult very possible this more was to donor out in patients donors even X we challenging not we patients. you with place pandemic traditional begin to it with certainly hope research just very, in Unrelated to patient. that the that donor stable is -- been donors align for months you to pandemic. is the know take patients. align COVID Vernon, because times, that And around being say What patient. see can sometimes the had that very Now, COVID we during difficult and to was the question And align the get

being our omidubicel cord blood the bank, material the that banks. of starting benefits cord blood with that One of is

still Phase was we for to appropriately our center. that cord were manufacturing During have blood cells them NAM III the our to able the access proprietary return expand that study, required the and technology

a as that from bring out sources. as into we market have So graft setting came something don’t that the omidubicel that given donor a you see was benefit other research to during with hospital

perfect. That's

see you any questions. So and Vernon, let if stop me have there

the No, That's looking that's was perfect. I exactly insight for.

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

towards the geared the of NK kind all programs. me, for few a Just

products? and you of Phase give study I. specifics a for finalized. the that that signaling and plan the domains new see that to Phase of type to barriers with little they that color GDA-XXX, How and Ronit that now you any has putting Can the in this pursuing protocol tested you us type used use be key First, if activate side IT describe approaches. are to I'm both to doses And constructs? just of these the I/II similar HERX the NK will -- given the sort this finally, on the point was CAR can Are NK wondering differences between IL-XX, sites respect been then And CAR maybe you of the of any same? membrane-bound in I also construct being CDXX many interest thing. in And competing are some constructs developers other could to hoping of GDA-XXX

GDA-XXX So Ronit, I/II? would Phase comment on you the

Sure.

as it I/II, at GDA-XXX the Phase limited we'll I a Phase I. appropriate a States, in a Phase the So of conducting number in sites United to be terms of first

using product the We with our tested we experience based are on that the University of using doses Minnesota.

operational number we We'll the on study the the of transferring to have experience. are And are. be in Phase sites patients by over that the There's of not similar dosing for experience using and be underway. be number we'll in getting year. sites, sites. potential in this II the tested After safety of the excitement that in used Phase of which study study the there are I that terms all announced we've To Is and activities the So and as up investigators the investigators be will complete lined the Phase will larger II. conduct later the but the the I, now a happening to enthusiasm evaluate based executional and share of initiating number of we for preparation cells, activities can yet terms number nor right Phase

of IND are to open on of study, and follow-up and the study design, file cleared the questions. patients And the your details more we'll once we some other provide number

Absolutely.

designated the rest the With a more at silent into and assured pipeline, planned on signaling intracellular we've detail lot later details confident I'm both this that pathways. are Knockout operate the quite manipulations appropriate to year, for to you today. submissions. Day the to that and an Mark, the we we'll intellectual present there? underway, And property genetic the all -- R&D go staying regard for that have the CAR But filed we're of with the are

Yes.

So well? the covers IL-XX here, as that that, and assume I member-bound

Yes.

Thank you. right. All

the really in the best at really just are looked the head-to-head lab. number and constructs doing a We've of best picking and comparisons different of

Instructions]. [Operator

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

of guys target? NDAs number there. We've oncology the cutting Between development, INDs are of lot at target NAM, like your I with and antibodies of age wondering going of expansions, is on get most This extremely a lot is You've HERX be got and a then maybe to see. on one molecules or in thoughts could at may which and but the if really technologies well-balanced small over the exciting busy ground, was are pipeline. ways covered I in sounds any an pipeline thrown just it. and certainly you it other

there's you what think some think might bring I exciting target And where particular in see too HER But in solid would the targeted need? the wondering is, failures Just you the tumor you this? that. see place way targeting you particular therapies. you mean, where unmet by very you develop to need a advantages to think presumably if specifically in noncellular

effective, has to used part strategy much It's be antibody. as in our engineering of an think CAR monoclonal not Herceptin, And if effective more make Obviously, it to the that excellent effective the with potential than that's we solid be is the to to able HERX the tumors. be combining CARs question.

very solid As microenvironment. have tumors you know, a immunosuppressive

barriers. so And lot are a there of

gastric data so what And as really HERX-positive lesser-known mentioned remarks in still prepared are some I was one the that are solid cancers of cancers. the no But has reported that days. in not any but there or in particular, is it's Perjeta. And and lot cancer efficacy, far, a think tumors with about early great of a number well served Herceptin by

So are refractory, could trial thinking to be models basket obviously, patients various a that program develop the tumor that allowing will to trial. lot the that enter we're the clinical a about and offer we

continue. at are question no further There time. this Julian, Mr. please

remains for on now. joining just for we updating thank Bye us today's forward to it call. to you me And look everyone Well, in future. for the

participating. this concludes call. gentlemen, Thank for and today's Ladies you conference

You disconnect. may now