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FATE Fate Therapeutics

Participants
Scott Wolchko President and CEO
Dr. Dan Shoemaker Chief Scientific Officer
Ted Tenthoff Piper Jaffary
Kripa Devarakonda Citi
Yanan Zhu Wells Fargo
Biren Amin Jefferies
Matt Biegler Oppenheimer
Reni Benjamin Raymond James
Call transcript
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Operator

Welcome to the Fate Therapeutics Fourth Quarter 2018 Financial Results Conference Call. At this time, all participants are in listen-only mode. This call is being webcast live on the Investors & Media section of Fate's website at fatetherapeutics.com.

As a reminder, today's call is being recorded. I would now like to introduce Scott Wolchko, President and CEO of Fate Therapeutics.

Scott Wolchko

you. Thank thanks XXXX us financial and Therapeutics the for quarter fourth results everyone afternoon for joining Fate Good call. Shortly after X:XX p.m. we be Investors Eastern results, Releases. our today, issued release Press press Time with website which under can Media found & the on section of a these

was on website our addition, the Media of our XXXX Investors Financial for thereafter, Information. and ended December the & In shortly year can under XX-K XX, Form filed be found section

forward-looking are law, Therapeutics reflect Fate to only underlying as as SEC not to they forward-looking Factors which disclaims that that change. on or cause by forward-looking statements of Company's filed in except required speak I of the statements would like to the events call filings provisions included everyone XX, reliance Undue in earnings actual from those any for in Private the Litigation Reform the Harbor historical and made, these form Please disclaimer on after statements. management to ended materially Before circumstances of are Safe was facts as statements Risk the results close we XX-K market update facts, Securities for risks today remind SEC may statements of and Act begin, of our XXXX, the These with the responses as be this can forward-looking statements differ by as such year date the made future these forward-looking XXXX. placed circumstances. the Except the the release issued Company's to involve should obligation on under forward-looking questions today. see well press December information, statements, statements statement that and conference uncertainties

discoveries and molecules small the Ding cellular quality Senior for in induced that renew focused of and Whitehead greatly Institute also Dr. has into Prize Jaenisch, reprogram of discovered Dan our a Development I pluripotent by ago founding was are the of Chief joined Professor Kyoto fibroblasts self cell Fate XX of in Dr. joined generation at Officer. the the matures XXXX. the using be Sheng and types Biomedical and that came and differentiate groundbreaking on a adult University, team Bob Research its Nobel Joining in the stem Valamehr, September Fate Shinya This the form Dan cells. body, of Therapeutics Ding, be by since member Shoemaker, the the cells. become Officer. stem February pluripotent Since demonstrating enhance pioneering therapeutic efficiency joined founding with of years and Fate Dr. over over ago four Chief platform at scientific product at Dr. that in to intent. Yamanaka Two Dr. formerly Company iPSC field. on reprogrammed I or of also cells; founding Biology with and currently XXXX. demonstrated proprietary Research; in beginning, Investigator can to the are Scripps of me our Scientific of XXXX. The January joined stem building awarded his the years discovery mouse Fate MIT a Therapeutics made at mouse nine Therapeutics the like Dan the certain XXXX to Gladstone could genes embryonic potential our XXXX. call cells, induced Jaenisch iPSC to cell today all on vitro pluripotent and stem cells in Institute Dr. Institute Dr. Bob founders, in human induced heels Therapeutics publication Rudolf reprogramming

and nuclease reprogramming collaborations we built that cellular development iPS-derived applied And lines are delivered iPSCs modify various scale scientists genome selection. significant technologies iPSCs. produced effective clonal on-demand uniformly footprint-free We use Jeffrey clonal engineering and of cell to by portfolio Kettering, of Dr. at Our and products; We iPSC single products and led applications. mediated University that methods treat for Minnesota the manner isolated genomic renewable Dan patients. and We Kaufman led of Miller, characterized T-cell patents industry-leading a an non- cell-based is master over Memorial foresaw In developed to the nuclease by XXX maintain formerly immunotherapies. and Fate cell is development to engineered, for stability. cell formed lines, products. vision source iPSC the master on product cost produce by create a using property iPSC of potential for Michel issued bold in lines of types iPS-derived XXXX, universal patent of of characterized, iPSC with cancer embarked XXX platform a in pending the deriving body. Sadelain the more doctors use with master to and of intellectual extensively for various NK off-the-shelf Through the Sloan supported we our Today, as

many therapy built that autologous pipeline cancer. cell immunotherapy treatment the rapidly are therapy believe hope with iPSC fundamental and outcomes. differentiated delivering the patient for and a limit of highly deep cancer of cell of have allogeneic our of transformational the change We that T-cell We cell challenges off-the-shelf platform confounding product in NK overcomes

long from to first XXXX, product first-ever patient February commitment with significant resulted decade iPSC field In a the now Our countless in in the research iPS-derived along U.S. treated of has the cell milestone. contributions FTXXX. others with way was in an the

therapeutic tumors. progression checkpoint either in line. failed universal development is cell-based door cell products. centers the atezolizumab and cancer Center beginning, to designed combination thought We XX from new the GMP FTXXX inhibitor and campaign. therapy UCSD and infusion a manufactured therapy assess candidates the in Despite and The mechanism with dose doses dosing rates in iPSC impressive failure a critical a as Anderson for single MD Center. and multiple for to of off-the-shelf off-the-shelf relapse now the The to presentation. do that preparation patients. study is compelling derived believe was trial the solid a Cancer cryopreserved investigation patients up pembrolizumab biological to therapy. in FTXXX, respond infusion-ready checkpoint novel as of majority bags reached immunotherapy Each FTXXX multiple or FTXXX safety relapse. of inhibitors, for clonal in In a FTXXX and strategy have clinical common of patients clinical Moores doses advanced master antigen is monotherapy landmark at patients observed cell that hundreds in NK bag, over inhibitor respond sites, are genes and FTXXX many of a with an checkpoint new for being conducted on or era confirmed One rationale. with shipped disease responders or were of mutations the is certain [ph] FTXXX disease not is response tumor as two-arm to associated with is in the were to opening We nivolumab, combining Cancer have of efficacy clinical for a a treatment have cell these of study cycles including of of available patients

the can mutations. multiple FTXXX loss FTXXX patients In it of to non-responsive potential Importantly, anti-tumor these promote displayed that non-responders activity advance in of mechanisms has functional mutations loss-of-function which rescue inhibitor checkpoint in treatment. studies, preclinical identified therapy. be with We may has are by believe to

demonstrated or FTXXX, and and multiple candidate this expressed a conferences high-affinity express XXXX, the for platform. targeted universal iPSC and from submitted off-the-shelf These cell have FC tumor carefully recognize, the our adaptive the application therapy, key of FTXXX for at trial outcomes. of and variant host clinical the and PK/PD anti-tumor receptor, being patients over addition the XXXX. micro to of engineered clinical hematologic is being of immune include in dependent product in trial potent MK And an the by of data doses antibody immune measured. MK January FDA coded CDXX mediates XXXV the on to derived mechanism well A FTXXX cell IPS-derived clinical numerous candidate clinical administered solid cell we of with as product from seller including studies We naturally readouts scientific malignancies in infiltration the has cells universal IND In initial cell two product of cells a changes as is cytokine cells. FTXXX, FDA CDXX to the targeting including cycles. biomarker clinical where an line tumor accrediting to In this emerging therapy U.S. multiple first non-cleavable also emerges look system variances dosing as cell clonal a one the environment expression. There with and FTXXX including being cytotoxicity find antibodies Numerous are cancer which response, the MK first studies is second that data ADCC. tumors biomarker CDXX. receptor. changes those antibody immune a with iPSC are gene treatment master are high-affinity the share throughout approved kill an tumor that in levels profile improved

have about are XXXV, XX% humans outcomes. of only clinical for However homologous improved

binding high has XX% about affinity novel by contain variant CDXX to Fc for augment XXXV. been antibodies. its receptor are The to tumor only targeted FTXXX homozygous of However, the expressed to XXXV humans modified

Our with allowed of improve with human authorized patients investigation CDXX that to In have FTXXX therapy, is treatment therapeutic patient XXXX, of clinical our the outcomes the IND CDXX. engagement FDA patients delivering monoclonal high-affinity to to application antibody February and undergoing low-affinity FTXXX FTXXX. XX% us objective begin by including inherently

to in FTXXX elotuzumab of the engineered trial upcoming treatment be myeloma. present with clinical To doses dosing as investigation, is antibody multiple relapsed/refractory with AACR three in FTXXX hematologic combination XX assess with to treatment new for hematologic in preclinical to for in annual expect multiple meeting, for we label, cycles iPS-derived therapy malignancies. The across first-ever clinical trial a cell the of rituximab multiple is in is of monoclonal with At our to in knowledge, FTXXX in lymphoma; the subjects cleared up open of efficacy monotherapy arms, safety combination with with repeat subjects therapy of and malignancies. and FTXXX the over dose worldwide. patients trial clinical an clinical intended of patients AML; expected treatment Our combination data the

enrollment We FTXXX study expect the mid-XXXX. for to open patient in

expressing iPSC FTXXX malignancies. universal first FTXXX, proprietary to universal CDXX rapid. product addition our built have off-the-shelf submissions. innovation of a Company's are designed that been XXXX and applying to and NK is T-cell pipeline which off-the-shelf FTXXX time to CAR cell and our product candidate, toward NK IND product platform candidates robust has moving the In we is And cell target

are FTXXX groups to differentiated receptor more advancing durable fronts for multiple using studies, functional Fc and CAR CDXX antibodies. into is our dual to responses and the expressing has elements multiple approach potential high-affinity therapeutic mitigate unique potential antigen a combination T-cells with believe and on escape. generation better approaches in tumor While spectrum CDXX allogeneic both and is target believe just CDXX has to first approaches. We with of second dual drive targeted a targeted incorporates the antigen these broad FTXXX three human autologous non-cleavable and highly targeted, we targeting CAR a deeper FTXXX

assay. shown that cytotoxicity of negative combination eliminated co-culture and rituximab we cells with a in in have CDXX completely proof concept, tumor positive cellular CDXX As FTXXX

enhance incorporates a FTXXX independent support. novel of fusion to Additionally, receptor systemic IL-XX persistence, cytokine

NK construct shown biology. that and used construct iPS-derived preclinical cells xenograft CAR growth is the cancer with therapy. studies tumor Dan to our ovarian containing designed CAR significantly CAR inhibit a iPS-derived for collaborator prolong commonly novel cell also NK Finally, and Kaufman T-cell specifically survival compared using as In itself markedly has cells model, NK

upcoming for the are scheduled annual meeting. AACR preclinical present data to We new FTXXX at

clonal we colnal a CAR, line off-the-shelf of the annual therapy allogeneic heterogeneous value engineering expect leukemia. populations regulate At T-cells mouse paradigm from each that collaboration application At submit comparable efficacy source a peripheral upcoming where Sloan blood in alpha with by contrast, in sourced, and the efficacy. off-the-shelf site-specific I'm resulting of one is FTXXX a to the pleased completely locus, repeatedly we expanded of the challenges characterized to T-cell primary constant will expression the targeting producing first data on to our late-breaking IND creation product CAR cell that acute patient for receptor to batch to and to CAR donor populations. unique used for master be cell for tumor engineered that master showcase that ability of both platform safety into batch to lymphoblastic FTXXX. led is upcoming cells meeting, the which control to from In lines, engineered, by in the integration investigation cell and and is renewable We revolutionary eliminate mass highlight significant ASH, derived an vivo can This mid-XXXX for of in sourcing a that characterize FTXXX with CXX includes to advantages less that run, company's TCR in of which the to the and meeting, with expression iPSC novel production products. We that with enhanced are can manufacturing compared announce AACR demonstrating T-cells of featured engineered T-cell cell also annual single prevent CAR renewable the CAR in of at clonal engineer, Sadelain, T-cell most in as product significant engineering affect limit batch Kettering, homogeneous as and safety of Michel clones Dr. abstract. batch applying is cell overcomes powerful GvHD. clinical donor iPSC and new FTXX therapy to select and cell intended cell variability the Memorial receptor T-cell single selection iPSC FDA to XXX AACR a our progression model approaches CAR rely that and candidate donor-derived be believe large intend to

initial for cell clinical Phase cell All In our [ph] therapy FATE-NKXXX iPS-derived therapies. VOYAGE and to failed tumors. continue for studies and from or ProTmune. enrolled be execution of ovarian clinical I three XXXX, FT-NKXXX progressive X to our moved clinical treatment the across managed FATE-NKXXX product advanced of ongoing effectively data recurrent November clinical three disease, candidates cancer; trials, programs into had pleased approved AML; DIMENSION presented escalation, the be for XX with relapse/refractory subjects for by APOLLO patient having subjects development, As and clinical solid -- we very data allogeneic dose encouraging which

in one-month cutoff, Anti-tumor in As at Last no treated of on Houston, were DIMENSION the no of transplantation toxicities X yet but syndrome, had of the activity was an data the the an an October time XX, limiting and therapy patients with FATE-NKXXX-related a we of presented and data additional were update release neurotoxicity meetings dose month, cellular at from October of XX reached events cutoff. X been reported XXXX cytokine FATE-NKXXX. reported, that GvHD dose or follow-up observed had not XXXX subjects single

infusion been months. had four to was plus non-responsive ate a January as infusion achieved achieved Reemerging and with was subsequently size. of reduction ongoing lesion to response. of a reduction size treated target lesion demonstrate FATE-NKXXX. treated XX% in was X.X data a And treated having [ph] renal with single additional for stage XXXX-XXXX as additional disease of in nivo melanoma, As cutoff, suggestive of FATE-NKXXX This a with with over with reduction an cell second of continued carcinoma patient target FATE-NKXXX, value, with patient ocular second uptake well a standardized and disease stable patient control single ongoing both in disease XX% pembro infusion

well-tolerated by profile and differentiated that We displayed data. T-cell an therapy. initial are encouraged from FATE-NKXXX appears safety these clinical was initial

FATE-NKXXX clinical dose as a of showed In addition, monotherapy. single activity evidence

establish and in an XXXX. open with study ovarian investigator arms in the centers for in Masonic well-tolerated DIMENSION tumors initiation. prepping enrollment a for the The provide X VOYAGE continued for time, and At look therapeutic and recurrent additional multi-dose trastuzumab APOLLO in Center. are with each strategy. centers at we of proof-of-concept at DIMENSION is study to establishing in FATE-NKXXX precedent these in the or FATE-NKXXX showed from advanced study patients, cetuximab, the to this Cancer open currently combination was X X for cancer, study, AML as second initiated Importantly, and enrollment Minnesota, study we learnings combination solid an for In of gain X persistence for an University update a dose of

In ProTmune, ASH, the data Phase study next X from ProTmune. generation allogeneic XXXX stage PROTECT presented to December Turning follow-up for malignancies our of our year cell we one graft cell hematologic at of with hematopoietic undergoing hematopoietic patients transplant.

SAEs and study XX, for of XXX outcomes moderate long-term transplant Since survival a reported ProTmune-related patients allogeneic As follow-up transplant alive XXXX cancer and leukemia-free; alive, are and only one-year with data no from hematologic XXX and with and of clinical survival CIBMTR severe relapse disease-free November to significant on were patients by relapse critical At there failure malignancies centers investigators, unrelated were that of subjects a time year events from is without and In disease. by performed a chronic contemporary in following GvHD. X or no moderate free donor relapse. alive at of remained intent, survival no conventional assessment over without without with subjects is one that patients graft-versus-host graft-versus-host are and events cutoff graft transplant median matched comparison, disease about X leukemia and disease-free only and disease. two leukemia of days, free curative and X X suggest X X life-threatening are X,XXX XX%, of data severe

see of bind the continue ongoing enrollment randomized stage momentum Phase strong in and We subject PROTECT. double to in X

available complete the with and XXXX. endpoints in mid-XXXX data in enrollment expect primary We secondary to on

of in for our headquarters off-the-shelf iPSC which [ph] Finally, to product for the each into and is clinical expansion design support San expanded iC GMP central comprised XXXX, mass that like two of for setup cell of highlight ipharm iPSC use and master a [ph] The to corporate modular The product multiple iPS-derived Diego candidates would expansion. is January for suite suites of build-out candidates. parallel. modular initiated manufacture lines I of feeds we in of in-house our supply product in differentiation, customized production

initiate supply with of thousands product our doses cell candidates initial year. We per fall expect to capacity of in off-the-shelf XXXX clinical of to in-house produce manufacture for the iPS-derived

for associated an share per Pharmaceutical and period for Therapeutics the $XX.X common for year. $XX to for our of growth XX, to December compared Juno advancement research $X.X quarterly XXXX. operating and adjusted expenses financial of in period of the as compensation $XXX,XXX, share-based in of million from payments including our million increase quarter employee preclinical G&A the the Company's primarily development the call for convertible and the period for $X.XX million Revenue year. compensation attributable approximately with stock-based expenses fourth adjusting common million I last associated that, Company's million was total stock And results year. expenses with Common expense R&D of short-term including compensation compared X.X expenses was employee professional under was fourth of of preferred The fourth the to Fate million to $XX.X to of questions. $X.X with product of were million increase XXXX. quarter common fourth $XX.X last Therapeutics. net compensation of quarter million after in last $X.X is cash, and of Ono in development quarter XX.X share was $X.XX the cash derived $XXX $X were XXXX, operating $X.X and expenses pipeline equivalents of into any Turning compensation, attributable or the Total and of expenses of same or net pipeline. Research incurred compared for up fourth of X a the the for to convertible XXXX. fourth to million were stock the to quarter non-cash a million loss was cash ended investments end the million our certain in expenses loss XXXX and which was primarily an The for per clinical of same and same to Company's quarter XXXX, XXXX the fourth Revenue each were headcount conditions. would XXXX million shares, collaborations were for from $X.X outstanding At increase increase million $XX.X our support quarter Juno fees. the open the million. the compared quarter like share-based G&A outstanding shares fourth to shares for product the with stock

Operator

[Operator Tenthoff Jaffary. first Instructions] from you. Piper Our with question Thank Ted comes

Your open. now line is

Ted Tenthoff

me you okay? Great. Thank Can you. hear

Scott Wolchko

Yes.

Ted Tenthoff

Great.

been progress. firstly, mean, have love guys I the testament lesson timeframe who I made and you So, that's that is the a this to really you've and upfront. see to history amazing over with, progress the working

dosing cell on was double I I congratulations first the upfront run check. So, of housekeeping of Juno. May XXXX. Are on you and still for quick just recognizing amortization? partnership patient One trial. think with then that it one to I supposed cancer. therapy know to of to have through iPSC-derived the the with you want that any

So, To just secondly, there does work dosing a I respect a dose the but of sequence? of How of still X? to sort And [indiscernible] period the the with wait dosing then, time, dose that patient, with what the is yet, of that is Phase through kind see study, Thanks. in patient? to certain any next want there. in had

Scott Wolchko

Sure.

obviously are and fees is recognized upfront, and recognized term upfront, the which -- estimated term So, being and there's performed. in or will generally being four of an is recognition, years, both be baseline paid collaboration, and the the being housekeeping upfront of There over amortize to the both on revenue research in also essentially cases as collaboration fees. the research and was We collaborations, the Ono. this we're development apply to

the in amortization fourth plus two as collaboration, the we the first recognize research to will of well $XXX,XXX associated respect with of quarter quarter the ‘XX, collaboration with over as in upfront, the the of So revenue $XXX,XXX pieces a end Juno was million does years. XXXX. four quarter. There The a recognized be similar Ono’s $X way. Juno in that about over will pattern $XX May upfront so be collaboration in will million, of payments, recognized development revenue, and

us In about million is in funding. addition, paying year research $X Ono a

And that as recognized be performed. so, will

Ted Tenthoff

you. Thank

Scott Wolchko

of Sure. quarter-to-quarter. in to dosing yes, trial, the much and two the the monotherapy should it inhibitor in a of arms first With patients arm. study, sequence arm; we there's monotherapy With so, dose able respect to The too obviously a escalation period. we treat not FTXXX schedule. goes there's at are of There -- in a dose respect the vary the are And to essentially arm first level. first checkpoint the on following the patients are

patient first dose safe, a and if patient be on cohort. third let’s you can to two safety treated day treated next later. beginning weeks There's can can and one; on assessment occurs it that The be XX, proceed then, call a day and the second

Ted Tenthoff

very, That's helpful. very

forward data Looking time. of the at getting throughout some that to AACR the Thanks for and year.

Scott Wolchko

Thanks.

Operator

Karnauskas next comes Citi. with Robyn from Our question

is open. now line Your

Kripa Devarakonda

this taking for for This is much so on Kripa Robyn. you Thank question. guys. Hey,

you to trials. simultaneously? further products And to over was I you build in about expect many So, facility, Scott, switch expand manufacture I this when questions. have to do couple make wondering you expect initially. different also, that your and you for could made facility I how GMP a of the you thousands out products grow the you mentioned, as out it manufacturing just of know, can how

Scott Wolchko

Sorry. was the What last question.

Kripa Devarakonda

in of said start you for product You that When would to trials to XXXX. the making clinical you do expect fall over product? your switch

GMP start think using the trials? product actually that do you clinical in you in can your you facility when So, your make

Scott Wolchko

Sure.

go So, backwards. let's

product that. in the just in to we we manufacture to our facility, this year clear clinical studies, be to So, this very that plan year about plan use

able So, are at FTXXX, objective certainly manufactured partners with for be Fate our to is and have do lined manufacturing think we with we We FTXXX Therapeutics up manufacturing launch within obviously this That FTXXX. patients an that product year. treat will well reach.

clinical With strong Minnesota, and products a We been of study. we products with at relationship the they've MCT manufacturing respect very University batches to at how simultaneously. for least can initial successful have manufacture and of many

lines As potentially using we I to to mentioned, is the stagger this for And in product do we way to customized can cell universal three cell products. setup likely very parallel. very master manufacture four products create

Kripa Devarakonda

Great, sneak more thank if NKXXX question one your may in about And you. program. I

two program you that have to strategy changed or in iPSC-based way? having your products thinking IND, towards Now FATE-NKXXX cleared any has the

Scott Wolchko

-- studies we're the NKXXX three enrolling mean, I are all open, patients. No. all studies -- are the

have studies well said we before of that that therapy. important stand tremendous and we solid conditioning respect They We monoclonal amount NK continue studies. hematologic as learning those both regimens, well to in with a biology firm as run. malignancies antibody and will doses to multiple We're as cell are with as tumors combination

XXX, developing So, every said, We absolutely to is for think XXX three enrollment NK with learning That one almost are iPS-derived candidates. I we committed suspect single that look enrollment I patient the studies. to for or be NKXXX tremendous study an would that amount. product if at FATE-NKXXX we're footprint you a in in remain cell whether that eligible it’d XXX, of the those clinical respect of the products, products qualify

FTXXX, up, include -- not study does multiple we FTXXX can you multiple clinical while not In to cycles yet open is monotherapy picked fact, enrollment, give for where arm doses AML probably over the patients. as a

Kripa Devarakonda

Thank you. us cash talked but I’m any already housekeeping Have you can about you if it, And I apologize runway, -- given question. color? one some quick you’ve sorry, provide

Scott Wolchko

over $XXX slightly cash. million We’re in

we're about million As basis on I cash went quarter. $XX through, a a burning

sufficient have we into XXXX. cash believe well I so, And

Operator

of Jim Wells from Birchenough comes question next Fargo. And

open. now is line Your

Yanan Zhu

This in for Jim. is Yanan

to the first FATE-NKXXX iPSC-derived think are be a the comparable the that product might is FTXXX So, reason as question And how and superior? NK there cell is therapeutics?

Scott Wolchko

FATE-NKXXX is a in clonal that of donor-derived tremendous a limitation donor-derived like And to from all like is with donor-derived manufacturing. Without batch-to-batch denigrating from cell all approach cell product. amount donor-to-donor allogeneic products approach. question. Sure. that is take therapy is I’m exists a NKXXX, happy with a way, any that challenged therapy. And products heterogeneity NKXXX iPS-derived

other clone You single a single clone well race as that and against select products. can donor-derived clones, literally as

be can that product to patients. given homogeneous potent incredibly an with in up wind doses multiple You

So, with statement, is way, donor-derived I in an cell therapy a believe is any do general this off-the-shelf comparable approach. just not

Yanan Zhu

on follow-up question T-cell another So, program. the have then a and NK on I for the program

-- FTXXX, will study the have for rituxan there for mentioned So, you initial example. combo with

So, rituxan just combo alone? the of curious effect differentiate to how the versus

Scott Wolchko

rituxan. that qualify have to they To will enrollment in have failed had for arm,

Yanan Zhu

same ahead clearance expect IND And the would you more FDA of addressed FTXXX product, the it so, the Thanks. the T to with be the iPSC-derived FTXXX, you T-cell of or rapid as iPSC-derived looking for of product? for do first is CAR supportive think IND the issue did take considered time will

Scott Wolchko

Yes.

or And an NK creation think, I interactions part of similar. based that I the exactly our of with understanding protocol, get the on and go which clones, it from that piece fundamentally the tell that platform about line the significant master time part whether I late good iPSC of of days FDA to in filed qualifying period and just process piece products an master a to it's then question. itself. and master July the differentiation having the XX to a belief or say, interactions ultimately are FTXXX of a T-cell, a it's took familiarizing we with cell cell are cleared of FDA, banks you of the NK the creating same. XX when of The the master differentiating is XXXX, banks, XXXX first of you a selecting would been nature November would almost even reprogramming to is there a banks, the of cell that cell big obviously we've cleared, product candidate. our cell, T-cell a was the our cell of creating

tremendous to are we're then with work clear lot our T-cells. respect I do benefit we have off-the-shelf will NK with T-cell there NK and with leverage creating IND cells look products been that amounts an doing to And first that of able to So, master the a and following off-the-shelf on product. from we've in platform cells iPS that learnings file the to I we think creating IND and first respect as cell think of

iPS-derived, of CAR in lot we've a historically lot of are pioneering think learnings, in product. from already and done a benefit and this I first we the significantly the So, there T-cell work synergies case that

Operator

Thank Amin you. with Jefferies Biren from the from question Jefferies. comes with next And expression

open. Your line is

Biren Amin

you're Thanks cells, my XXX dosing guys. XXX it taking in program, XXX to up seems whereas XXX dosing questions. to Hi, million Yes. the you’re Scott, the trial, Hey, for cells. up on million

So, that rationale higher XXX? what's for the dose drives the level

Scott Wolchko

to X as three with cleared, protocol the dose cohort, FTXXX. that up IND we the in we FTXXX, Yes. go submitted that put we two put dose dose IND then a to to for first therapy FTXXX. dose first dose to we We in we started include And it design. getting we FTXXX, these mind, restricted included two on study cohort higher with can cell we initially amend quite the levels. a higher FTXXX very FDA. It's based to the Keep frankly necessarily and IND it will the was took with X I traditional levels, the matches we when put we IND with by when When with front a conservative to likely up third and cohorts, When intended application that a put the approach we FTXXX, dose level feedback not iPS-derived FDA. be like advance certainly through in, in suspect the with of FTXXX in

Biren Amin

rationale similar short IL-X scientific I in XXX lympho administering you're the cells? on XXX then, And And think program, what's the course after administering with programs? with IL-X short requirement depletion. Is these the course also there

Scott Wolchko

Sure.

space support studies IL-X. been been have literature confounding. been the important with given instance where There's clinical cytokine NK studies be There specifically and So, in the cells support, NK for support been given certainly bit where a obviously, cells cytokine have experience other have is cytokine can IL-X. and and without

And is support. respect there in of provide so I for are rationale compelling -- patients, cell obviously that's one transfer the is clinic think the cytokine enough, with any necessarily support there way as releases been can cytokines that firmly know, the other or body you yet you Interestingly as of don't therapy. in established condition adopted there to

And three regimens the NKXXX one with across are NKXXX, instance, learnings studies. three that have respect being to so, the different just we used of getting we're conditioning for

and they looking, at for instance, how cells. are simply conditioning we So, support the cytokines through released that carefully are NK

enate the immunity, interested FTXXX are to One cells. adaptive administering data bridging of we respect bit that is that specific do with and seeing the on to and things could with both T a respect sensitive potentially that we’re we're based IL-X, regulatory what to

Biren Amin

guess, and CAR today? compare this I to program X-XBB on have pre-clinically, or and potency then, it does how you persistence And Okay. compared on CDXX XXX

Scott Wolchko

Yes.

cell CAR that we've that and in comparing cell head-to-head NK of in process we doing respect the to NK with CAR versus land T-cell. are So, done

Biren Amin

then, last Okay. question, a XXX. maybe the on just And

a this CDX program. think is I driven T-cell

impact So, its do that of CDX that you believe, devoid would long-term T-cells efficacy? given

Scott Wolchko

in seen have suggestion of any not models. including that, preclinical vivo We

Operator

you. Thank

next with Capital question Do Markets. BMO from comes Our Kim

is line now Your open.

Unidentified Analyst

Hi, being I background and that and This in was to first filling had able that, to prior follow-on dosed. little portion? of if the the if [ph] on to you're bit treat I could the a Is a first a had patient to And proceeding prior in monotherapy wanted portion about patient's a therapies into wondering to need prior of number initiation is how with a you you clarity cutoff study. combination just give you're dosed? there the patients terms on Neil FTXXX Do. then, of any guys. us give see type was And to thinking for as the question about they that more I cancer

Scott Wolchko

Certainly.

there I FTXXX this are patient not I'm With going respect combination time. a how with respect profiles at mentioned data that disclose transition any So, three patients at to to the arm, into a to safety and first; there's the -- XX-day assessment. the in monotherapy simultaneously; delay can a arm there's second second The goes and level. a there's dose patient theoretically and third first patient, between go XX-day we

As safety arms independently. and assessment soon are arm, both as the you open the clear monotherapy operate XX-day in

arm the XX of the So, days. combination by absent trails, DLT start

Unidentified Analyst

question. That's other helpful. Great. quick one you. And Thank then,

to first I the And are using FTXXX. dosed same patient when you you be are had you FTXXX? you clinical sites as expect for the think mentioned then follow-on, for as a

Scott Wolchko

disclose that We do yet. not

Unidentified Analyst

Okay. you it. very much. Thank appreciate I

Scott Wolchko

Sure.

Operator

you. Thank

Our Dana SVB comes Leerink. next [ph] from question Grayboss

Your line now open. is

Unidentified Analyst

question. couple them. A for of Hello. Thank the you

on trial for first FTXXX. design FTXXX the The and

FTXXX, how if out? I whether resistance select can you their type have collect on see data, wonder coming that collecting when some for cuts to And initial start of of hypotheses mentioned the you data and that FTXXX, patients anti-PD-X. based for in we’ll You you're and to data you'll biomarker some on an a biomarker

Scott Wolchko

yes. The is, answer

those the FTXXX that not, enough We important. it's Cooley. to these collecting for probably clear, loss is in think We analyses in that but data go. a developing -- can NK and Fate cancer absolutely necessarily biomarker studies. the mutations We’re herself of be from be Minnesota. reaching to all know, studies actually analyses really that the function She prides years collecting of from cell-based start, arms best recently are the similar years We're certainly in get to running -- of we therapeutics respect part from experience of we tremendous was be immunotherapy in cells on We’ll and cancer working you She NK the the information has of assessments cells with in very data get patient University the it doing to and biomarker assessments that we and the and done fortunate studies. be go that analyses. has, with share hire Sarah the she as types -- conduct will

of and to So, analyses. types committed we're ramping absolutely these

Unidentified Analyst

you. Thank Great.

you clone cell that and some Now, have do can have maybe or point you a clone and very theoretical line? line master and indefinitely new switch FTXX, use master clone, to and for you pick at new a FTXXX a question. When

Scott Wolchko

one line experience from fourth them example. FDA, line for master have about in can, for in a instance, We fact, particular and what And FTXXX is for FTXXX third, are take our we reason a and of We But, do. not functionality, think if That conversations line a for different use qualified -- the these a we to use master that type an master to case. did becomes any advantages more creating think master you've adding use far, cell already iPS more create cell indefinitely. of a in do our intent the So and unique line bank. second, is one indefinitely. with a master as that as potentially don't to using for excited cell a we of We that basis attractive, edits, we that very about approach product. cell cell especially as can't

Unidentified Analyst

IL-X any generation question, next have less Thank the of… cytokines of last cytokines the using instead for IL-XX toxicity, the of you. your or either One considered Very helpful. support, you

Scott Wolchko

conditioning we with we've certainly a is thinking that are looked a continue with initially certainly and I want approach. have this Yes. one first about mean, a this. thing at I mean, look this platform. tocombine we -- obviously is combined at agents is to of And we profile. This use well-established and regimens the kind that

but look there's start. place potential so, absolutely not some we think to there, And it's I

Operator

you. Thank

Matt Our question from Oppenheimer. Biegler next with comes

Your now open. line is

Matt Biegler

milestones. the Thanks for congrats in and on me some sneak questions letting

wanted is recognize, critical into is responses? more do still theoretical But, I follow-up you I any blood? very evidence seen And from you about that that this expanding expansion So, have a to data cell And ask objective emerging peripheral NK believe achieving is some of NKXXX early. NKXXX. the to translational is, maybe

Scott Wolchko

Yes.

for looking we're in we're -- mean, expansion, not at NK I this wouldn't seeing say So, land. you're and to we probably cell aggressive instance, T-cell seen, I like have accustomed

cells, persistence for have profile to drug-like excited things is we of cell So, essentially different -- our looked therapy. than very than at of we're expansion. trying that a is potentially different the is certainly achieve NK But which which about one

and period in extended believe -- with combination period and of then what with actually giving to to with over single accomplish to we as doses are body dose best perspective, it giving going being the So, of I sort time. multiple opposed single time. for itself, letting be on by a dose that way in is exposed when we of, essentially whatever an the of that agents therapy, that going other cell able pursuing strategy in we where to interested agents other therapeutic doses including think from create a are instance, over multiple is is following

give drive exposed in and believe going an dose later. give to months but by of cells you creating for a what's of We more on and in a time healthy the is period the X month responses. it has later, coming to a be essentially to the influenced that expand cell, is certainly potential X and or intend durable autologous and certainly has So, a time, to deeper over instance, prime way body of potential a wave a with one you to profile be going months better persist, later, PK/PD --

Dr. Dan Shoemaker

and Matt, X add, longer In the cases a similar was than one dose doses, study, second the to Dan. received X thing the and persistence in that some profile, XXX patients the is first And this bit the dose. little

multi-dose So, that with and bodes start FTXXX as that well for was format FTXXX. a with dosing our encouraging experience patients first we

Matt Biegler

And maybe the a FTXXX. for question strategy quick on

some maybe had meeting, in some Tandem few was lymphomas, there or activity So, Dr. crew remissions presented NK help at of you I'm less it TCT heavily you this And data at trial? upcoming kind a the guys guess way, any updated wondering and complete in hone weeks data from for just pretreated the and it's as in called ago. you follicular look if Miller's indications I but DLBCL They notable myeloma. can

Scott Wolchko

that by believers mean, data in I we're encouraged certainly interesting. I ADCC. We're think, it's because big

I approach significant that a high think, there's some think, versus donor-derived therapy, have differences in back fundamentally pretty even approach, versus the donor-derived CDXX. I to off-the-shelf of cell therapy a NK of if question FTXXX earlier cell again, might expression an NK

CDXX. about, a high-affinity As XX% of talked patients of variant only we have

on single low -- a every a had high-affinity for the aware not wasn't segregated a high variant. versus I that they the database, look bring data donor but FTXXX, whether patient, at I'm So, closely, whether we with didn't the instance, can to. Obviously, experience I

particular, CDXX cleave can CDXX receptor, activating in the addition, an while in challenges CDXX, therapy In donor-derived body does one the cleave of engagement. with and upon cell and

we've FTXXX, only is mutation the receptor non- cleavable. a not with receptor high-affinity whereby is variants have the a we so And but locked on. Essentially,

And biology, so, FTXXX. with you if will, to a synthetic therefore, is respect this

that our believe through enhanced MKXXX with the cell the recapitulated but to cell therapies, in certainly, So, going engineered build of just what's learning scanning we that we're on there industry will that continue and donor-derived have be fundamentally from are cannot therapies. We're products transfer including functionality respect experience, own building therapy. cell out that, including fundamentally to will adoptive

Matt Biegler

to to Great, you. thanks. new on Dr. And her congrats Congrats role. Cooley

Scott Wolchko

Thanks.

Operator

James. Thank Reni with you. [Operator Instructions] Raymond Our next from Benjamin question comes

is now line open. Your

Reni Benjamin

signed Hey. development you can in the the and Thanks occurring new the for on congratulations clinic? when the questions -- kind little and when you licensing and taking regarding see be progress. about a bit you that Scott, agreement that just how BCMA talk you the targets of might

Scott Wolchko

Sure.

this with we a lot target. in agreement think, done to developed signed as of the group Germany has I that a novel in domains and BCMA over be has work developing binding

their-- of that other instance, done of work bind In BCMA, for domains. they to compared binding some in comparing ways fact, have they lot a the

seen And so, very we from them. that had data were we the by intrigued

developing we BCMA data binding a potential would not like that are with We potentially to program our with through But, success yet. able it we CAR already look given be to We're in assessment, analysis combining for hit that at we two CDXX combining, to those I of targets at preclinical hands. stages including We're earlier but and with with certainly FTXXX. could once. very are receptor is that interested say a program accelerate, this a of are we're we assessing the doing FTXXX, that instance is in, domains

Reni Benjamin

guys And approach, at you NK or BCMA other favor constructs cell players the you are of are do given evaluating both? T-cells, there maybe more are that looking

Scott Wolchko

I said are other knowledge, therapy belief there. I've maybe circles, both. cells of before, part evaluating only as but curative in certain obviously definitely that given our There's is allogeneic are the to graft. think are We're out a T-cells our given. NK this given transplant cells

T-cells and play and very likely role a role pretty and cancer. And foundational so cells complementary synergistic we attacking think, in a NK

we T-cell the manner. and bring think of our our company positioned, from NK-cell off-the-shelf that clearly so, we part together perspective, objective only can and an are where And we're therapy in

Reni Benjamin

for little any one then, pretty And how experience bit it. master bank? you equivalent? one these much from Got about sources, master all look they final with of cells And a me. iPSC cells the source talk you for had are the have your cell Can or just different

Scott Wolchko

sort they're no kind source I'm how created different donors cells, and Now, necessarily. donors that various from they're of reprogramming get have I to definitely which of source equivalent sort yes, and means of back trade donors We donors. an -- how wouldn't into absolutely the good two the cells by originally fundamentals, history to any we stuff. cells going we from all equal. about But, say, and select entire of efficiently we are not not And secrets we assess

that I the there how with to goes so, of you mean, And right your creating do knowledge yes, donor so there trade line. respect select a into master is secrets lot and

Operator

And I’d any I'm no questions time. remarks. showing you. Thank over like turn Wolchko in at further closing the this the Scott to queue call for back the

Scott Wolchko

likely. Great. to speaking we participating today's AACR in very in Thank with much everyone of couple you most next for call. forward weeks, you you at And look see

So, care. take

Operator

your Ladies participation Everyone may you disconnect. does great for and program a conference. and concludes gentlemen, This thank today's in day. all your have you