FATE Fate Therapeutics

Scott Wolchko President & Chief Executive Officer
Wayne Chu Senior Vice President, Clinical Development
Ted Tenthoff Piper Sandler
Robyn Karnauskas SunTrust Robinson
Jim Birchenough Wells Fargo
Alethia Young Cantor
Daina Graybosch SVB Leerink
David Nierengarten Wedbush Securities
Biren Amin Jefferies
Mara Goldstein Mizuho
Ben Burnett Stifel
Michael Schmidt Guggenheim
Peter Lawson Barclays
Call transcript
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Welcome to the Fate Therapeutics' First Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. This call is being webcast live on the Investors and Media section of Fate's website at

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 first 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 and the on section of a these

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

to that on except I the statements would the statements. Securities like involve differ Litigation those call everyone historical Safe in These management Private to Before are that statements we facts, for statements of risks remind statements XXXX. and Harbor the begin, Reform and of Act responses results could this forward-looking by materially such provisions made from forward-looking of to under uncertainties questions actual conference cause

release market March the SEC see forward-looking our earnings that statement disclaimer on included ended filings for in well Form filed with as was company's XXXX today. the as in XX-Q the the issued press risk company's SEC today quarter Please XX, after the factors the the closed

future obligation which should update underlying may they placed be reliance forward-looking only events to statements as required and circumstances. information on Except reflect date or Therapeutics change. Undue of any as these these Fate the are statements disclaims facts not as statements made speak circumstances forward-looking law, to by forward-looking

Vice President Valamehr, Shoemaker Chu Senior Dr. Chief Clinical and Chief Joining Development. Development Wayne today's me Scientific Officer; Dr. on our Dr. Bob are our call Dan our of Officer;

the several recently key we on discuss transformative months, on achieved with comment during we of impact will pandemic highlight past the milestones into collaboration our and the Janssen. the entered business, I COVID-XX Today,

our to and day-to-day impacted unprecedented lives The have with to compelled our confront significantly daily we operations change been pandemic these has global COVID-XX times.

and the of and to continuing extended taken operate families employees protect community, the our our measures their to We health business. while numerous safety have

potential manufactured pandemic operations. that with inventoried clinical after we Shortly to patients. stocked our JPMorgan we sites implementing products our our Conference, our and administration the began confirm lines to clinical and preparedness for enable locations master and clinical iPSC products were changes a redundant in to reassessed off-the-shelf our We

We personnel with planned and also our in-house suppliers the our materials manufacturing support policy accelerate We work-from-home to of the campaigns. essential conducting implemented worked manufacturing key those laboratory of restricted activities. to on-site a GMP and to conduct sourcing

to the We care worked monitoring, closely investigators promote with continued remote activation safety site of data and study and participants, and our sites implemented patient clinical trial preserved integrity. and

our have us of control believe we established have capabilities resilience that to The of will with commitment, resolve weeks. objectives. through GMP resourcefulness, allow operational and and including challenging these advance full us business our We manufacture carried operate employees

We have enrollment clinical of new trial the site been patient by disrupted the and been cadence slowed. COVID-XX has as initiation though

our some clinical clinical to we programs timelines for development across data and our committed these introduced enrollment projected with trials. our to have disruptions respect While remain plans readouts uncertainty and

which Nevertheless, momentum to we all programs business patients. have enroll our maintained of have significant clinical three across continued

immediately For doses our infusion-ready tested in cryopreserved been manufactured released each we of in have and inventory studies. and hundreds programs, clinical our which have are stored for of available use

an clinical product. United We is advanced solid in IPS-derived study States trial FTXXX enrollment with of with completed successfully the we inhibitor the trial therapy milestone cell in dose is FTXXX the a our program significant checkpoint With have I the tumors. clinical treated dose of level at cell I the to believe combination XXX-million FTXXX our now escalation respect FTXXX three patients Phase in stage ever as clinical this Phase and first in

cell a is up to it treatment the cycles. over once-weekly Additionally, one FTXXX clinical consisting evaluate of outpatient two of of a treatment three followed ever course, doses lympho-conditioning novel multi-dose by therapy XX-day trials of to first

I'm of no pleased or neurotoxicity, toxicities, ≥X in consistent clinical FTXXX to report study, adverse cytokine that stage by the incidence reported release serious dose patients. with Grade were dose-limiting and there X no Phase FTXXX-related the three our disease adverse of no observations these prior in events graft-versus-host events syndrome, escalation investigators

up Class dose to in study recognition X the three X patients FTXXX cell partial sites Enrollment with Phase exhibit cancer in of the cancers NK non-small with clinical making these inhibitor lung therapy resistance patients expression killing. or proceeding susceptible loss highly to of expansion where at MHC stage to is XX% cell checkpoint of complete and

to three inhibitor once-weekly treat support dose to XX-day administering dose XX XXX-million at in outpatient stage, along the over expect up the doses with checkpoint on patients up expansion two to cytokine per in the progressed. and We FTXXX failed cycles the cells or IL-X patient with of setting which

therapy our cell IPS-derived the to product the clinical and from iPSC FTXXX first the program undergo is platform emerging in investigation. world second engineered

continue dose combination AML the lymphoma. in monotherapy with conduct of escalation We stage and Phase as for clinical rituximab X to a for trial the B-cell FTXXX advanced

sites successfully total active of have sites additional for We three with currently additional on are and a sites two remote two working we activated activation.

advanced relapsed tumors. clinical or monoclonal anti-PD-LX least scope FTXXX combination We PD-X component January, of and with who evaluate refractory an PD-LX, therapy. in initially of in following our IND advanced one avelumab, second enabling to anti-PD-LX clinical the a solid patients In and FDA FTXXX ADCC intend at tumors therapies checkpoint in inhibitor expanded with investigation solid line successfully immune we to range antibody have our tumors. broad are with combination FTXXX the to across of solid addition, allowed EGFR for application In program HERX-targeted

enrollment with in combination in the We expect patient months. first coming avelumab

escalation advanced X our and the patient for FTXXX stage FTXXX trial With respect lymphocytic dose to malignancies of program, treated the first Phase leukemia. in clinical B-cell the chronic we

uniquely evaluated multiple tumor-associated with engineered components active potential. designed ever be immunotherapy excited We about on cellular cancerous anti-tumor is FTXXX target milestone. expressed the best-in-class for three are to is particularly to and antigens B cells patients this clinical first in

potent non-cleavable In and such that One currently addition sites a FTXXX NK expresses antigen also transactivation CDXX. to of cells CDX for Fc CAR cells additional are and IL-XX high enabling additional remote and as support. novel promotes activation. FTXXX antigens CDXX without is currently CDXX proliferation survival affinity receptor targeting cytokine receptor three our site cytokine T associated multiple tumor novel fusion, of and a on complex the proprietary we CDXX, targeting need working with a systemic expresses active

is days to relapse stealth treatment remission rituximab or lymphoma. of enroll therapy. second with The to hematopoietic combination high-risk FTXXX. Sponsored from FDA trial XX the within have patients Minnesota, study prior clinical In new Cancer this the expected FTXXX addition, of I'm Center, for transplant. by dose application relapse we that clinical University following potential of achieve program up patients Phase allowed based of to three our non-Hodgkin IND Up of complete to in administered on for announce to will Masonic considered the for investigators a is pleased expanded undergoing be early in relapse assess also XX FTXXX partial FTXXX months XX or the successfully scope transplant prevent levels clinical on intended as failure to autologous of X the to

product advance features innovation to our pipeline including We and and development. on candidates additional also build into engineered of next-generation rapidly continue of ability excited NK to rate IPS-derived candidates engineered functionality, be preclinical about cell add our clinical product our

our and FTXXX I'm therapy. the pleased to derived is receptor announce of for first in cell clonal multiple line the expression edited application an a anti-CDXX side. myeloma. mitigate that antibody-mediated to recently for We FDA anti-CDXX antibody with IND therapy monoclonal CRISPR-edited, to submitted engineered investigate FTXXX treatment iPSC iPS-derived intend hnCDXX FTXXX, we of and have IL-XX fusion fracture CDXX elimination to for with clinically the from combination

clonal as serve FTXXX In we the clinical as cellular addition building candidates. iPS-derived a FTXXX product future the to engineered NK line master candidate, cell for for a may backbone iPSC foundational of believe

this of iPS-derived for Meeting, from will Therapy FTXXX at off-the-shelf an starting FTXXX, iPSC of NK Society Virtual material. master the existing engineered line iPSC week's program Cell as and candidate, American CAR-BCMA, using example, engineered product line creation our a master Gene Annual cell we highlight the For

ASGCT, product our recently stress have engineered data announced line iPSC proteins we forms initial the for existing also CAR-MICA/B pan-tumor from targeting candidate associated where preclinical program. the FTXXX Similarly program, at present master been will developed using

ultimately path Sadelain off-the-shelf formed cancer. curing in with collaboration cells many five to and to Kettering, developing journey the As led cancer a NK about foundational this cell may cells T years mission our both Sloan types cell out in you critical of a CAR-T know ago we iPS-derived therapy. role in XXXX on as cell-based of when by Dr. delivery Michel play Memorial guide We to both patients, included our iPS-derived set immunotherapy bring

the field and learnings we've TRAC the expression innovate CAR CAR iPS-derived functionality and creation expression, risk. mitigation cell engineered to cell T the emerging master for continued the eliminate the a of We locus and the our line disease into cytotoxic clonal of and with CAR-T inserted followed pioneered programs. state-of-the-art regulate CAR-T iPSC to optimize years, in to features Over a activity include cell graft-versus-host science clinical autologous from receptor

models cell cells T the protocol occurring We alpha-beta we in primary product our against therapy. founder collaboration raised match preclinical of of counterparts. most the their closely refined with And goal under CAR-T that the CAR-T naturally CAR-T differentiation iPS-derived potent our cell stringent making cells our with candidates

elimination application we CAR submit locus line expression. from I'm master XXX edited track a for to CDXX a TCR off-the-shelf quarter remain in second into cell is IND novel of announce FDA first FTXXX the to derived world's TRAC pleased therapy. our the inserted CAR-T to on engineered for with the iPS-derived that and FTXXX, the targeting clonal iPSC

We bring in FTXXX the patient XXXX. first to to continue to strive

best-in-class Janssen's bring to deliver iPS-derived us. iPSC to invest in to value scientific I make together is increases about immunotherapies brings with and comments deep industry-leading significantly partnership product a our collaboration domain cell-based expertise to The manufacturing transformative The in iPSC ability newly operations, innovation, leadership collaboration build for patients shareholders. it I'd commercial-scale Finally, our believe Janssen. oncology cancer in and like platform. formed our few And

is and Our cell develop commercialize products. mutual NK iPS-derived to and research, off-the-shelf objective novel CAR-T CAR

malignancies The to of constructs. treat we collaboration collaboration includes cancers and four domains specific and by candidates. hematologic and that The is being tumor limited a the associated the CAR is CAR-T Note four collaboration With include both to collaboration are it antigens. are antigen that not Janssen the of contributed seeking construction targeted-based number for deep CAR to and is solid proprietary respect tumors. and the to scope, binding antigen a this to directed to both to cell are targets directed candidates up NK

targets. antigen we the fact, Under preclinical will In specific can innovation, innovate together, conduct CAR candidate. NK next-generation develop for collaboration those and against to and cell conduct collaboration and iPS-derived and development, IND-enabling continue collaboration, candidates activities we each four CAR-T drive

entirely by that for Importantly, preclinical the funding the all activities will IND-enabling receive under perform full Janssen. are And development we these activities all and collaboration. funded innovation, we

an of of collaboration development candidate. right option. clinical have and an exercise Upon commercialization submission to sufficient for obtain license, IND, for activities Janssen And the the the will exclusive completion allow an the exclusive to of

will Janssen worldwide we collaboration development be Janssen's cost, responsible manufacture, And clinical will solely be the for of primarily and for the at responsible commercialization. candidate.

right to losses attainment development profits certain of share clinical United candidate subject we concept, elect and sharing And proof have collaboration to each in States, the costs. co-commercialize. the the upon in Janssen's in of equally For to

like that or are pipeline. or our collaboration, collaboration currently current I'd product include product under under development candidates, that any part preclinical to candidates not us, clinical Janssen otherwise of do by the emphasize, the

product our owned will deep pipeline exploit of to We wholly continue candidates. innovate independently and

an With an was respect received of form million million economics, $XX to the upfront the equity cash at and collaboration share. $XX in $XX per of in investment was April payment $XXX we which million

$XXX collaboration For we development, antigen And receive for for of to up milestone to are achievement the eligible upon target, the regulatory each of additional million up first candidate. $XXX candidate. specified first the collaboration payments and million to milestones sales

in are third in -- payments, proprietary for and up milestone second first million candidates. additional payments eligible in targets, the up to fourth For to $XXX And collaboration antigen each each of each collaboration of to million we receive $XXX candidate. the for milestone

and to In are up up upon targets each upon milestones. development and assuming across to billion, milestones four payments one of eligible collaboration antigen of the the total, candidate, of of receive achievement billion, achievement $X.X we commercial the $X.X only to regulatory

subject the the In United profits equally States, milestone collaboration elect we to in co-commercialize benefit particular are event the candidate, payments these to reduction. of a in losses with and the sharing

commercialized addition, of on products to are up receive double-digit by In we are eligible collaboration sales Janssen. that royalties mid-teens, to ranging net the

key collaboration's I With highlight would value, strategic respect to several the points.

partnered commercialization with in First, teams clinical one we entire scientific expertise. oncology strongest with one, outstanding of have the industry, the development and

We identified and collaboration using building proprietary binding products. Janssen, highly will creating optimized differentiated be opportunity to the candidates domains, by develop

dollars substantial the features to committed the And we will and significant and for has our next-generation and Janssen development functionality, research to the to annual work Second, of development for collaboration's processes support be research including drive commercial-scale innovation, GMP manufacturing and payments scaling of receiving operations. plan.

across pipeline. our rights Furthermore, to opportunity product industry-leading iPSC the to our our an retained And we for platform. use iPSC collaboration Importantly, product innovation leverage this for expand product platform. us represents

existing not encumbered in pipeline, our have any We whatsoever. way product

equal rights opt of interest, U.S. with economic and For in and the profits each in losses collaboration co-commercialization significant candidate, share we the to retained to

would products. of the I that responsibility highlight retained collaboration we manufacture Lastly, for

collaboration provide COVID-XX we're joint a And manufacturing and pandemic. a Janssen committee, for can support thank facing activities, like are to cell team. during oncology all I uncertain challenges, advice Janssen times. new in world-class scaling manufacturing we this the the operation. would building These have and our where formed Under therapy

Janssen appreciative trust that at effort in finalizing I'm their the of was collaboration partnership. dedicated really and and the team placed Janssen this team. to commitment has midst to pandemic this Janssen significant the the our sincerely for in grateful unwavering And that the in time and

ourselves collaboration to off-the-shelf novel Therapeutics medicines cell I'm life-changing really cancer immunotherapies NK begin dedicate build together transformative as excited and to Fate CAR-T to CAR and bring and patients. we this lead

same Turning company's cell compared Pharmaceutical. million Ono the with Revenue first was the last was $X.X Revenue CAR-T the period of derived in to IPS-derived to our quarter year. financial current results. for from the million quarter XXXX $X.X collaboration for

product attributable compared $XX.X first of our expenses compensation compensation of share-based same for lease development under candidates, an million collaboration R&D the Research including and million and new with last XXXX to and expenses for associated development clinical the and our for headquarters. of quarter Ono the corporate the facility with was the our period in to year. increase expenses employee in increase conduct activities including were $XX.X The primarily manufacture our research

The the compensation attributable primarily increase expenses and and General and XXXX million first our million compensation last period quarter increase expenses were in for employee administrative $X.X same the G&A accounting in of an for in $X.X share-based compared legal was year. to including to fees.

million, first expenses of the April cash Total $X.X of excludes of with received compensation investments cash, $XXX million of operating in company Janssen for collaboration. ended quarter and The the with the quarter million of XXXX non-cash which first million. $XX.X equivalents connection $XXX net were expense in share-based XXXX

and into in stock certain X.X million preferred each stock outstanding issuance X.X with collaboration. outstanding was stock common of is outstanding Common in shares under April the XX was conditions. shares excludes Janssen convertible convertible the which million shares million of Common connection stock of shares, five

have of demonstrated these and our and our employees we to unwavering I'm to to and T-Cell act during ability challenges passion. and commitment are NK patients remained bring to changing cells IPS-derived our unprecedented cancer proud times our experiencing I want for significant and pipeline swiftly immunotherapies thank of The instability. to times. engineered pandemic commitment in lives has our shaken us their resiliency. many global all that first-time

your members And up I like questions. sincerely hope Thank all to call and and open of staying family that you now to I'd safe. the well are you.


Sandler. of Ted from comes first Your with question Piper the Tenthoff Instructions] [Operator line

Ted Tenthoff

see applicability Trying Really update development to really we Great. year. more currently. the think on to there next little want see a pipeline, Thanks. likely would other sort into on advance just out clinic XXX. get guys. exciting. the XXX for where Congrats a Thank the of to get vis-à-vis for most bit that and excited one the and color But sometime in you, products sense do data you it's the of across all get

Scott Wolchko

Wayne from Francisco. – Sure. Wayne to take San answer Ted? question want do currently that in located you that is

Wayne Chu


think some So product clinic. activity. on to intriguing FTXXX, have and we excited raises FTXXX possibilities very based also expect fact about development that in I a very yes, what the the given And we should see know we it entering we're also questions where

from clinical appropriate think our that each most are as I that perspective indications I And we data for finding the risk-benefit a development clinical challenge gain profile of the studies. products Phase is in the of

by will that most within answer and more to these be the that terms see the and And largely fully B-cell so in which in develop dictated what products. lymphomas because tolerability question we will of importantly indications are then think and I your efficacy appropriate more define what leukemia safety to

Ted Tenthoff

Great. very Thank you much.


Your of Karnauskas line the next with question SunTrust comes Robyn from Robinson.

Robyn Karnauskas

Thanks ones. guys. Hi, Two question. taking for my

time first of I gotten Just just data trial sort the of all happened, skip how can sense COVID of what in XXX or the know were So visits? where have enrollment? when give want as when and you might And just point so patients sense you any were disrupted? that don't many flowing XXX FTXXX of you trials through frame define were to a of there us were getting impacted, have we any like

secondly, that future are does you. How on them? you about would the from -- then doing have deal. deals? on the thinking And anything congratulations prevent this And Thank deal you agreement

Scott Wolchko

I'll those do in Sure. order. reverse

the Janssen antigen from are mutually that on deals, the four in future doing us we than nothing prevents with exclusive there's So targets. Janssen deal other

on working antigen with be specific we're Janssen four those to So targets, exclusively targets. four named clear, which those are

every pursue potentially and you targets obviously, cancer more you there of emerging immunotherapy, the of think space So and each could that day. if countless are

opportunity our as and our platform. think continuing we partnerships yes, have do the pipeline we to to leverage so about absolutely to And build continue

are I engineered this multiplexed exciting that one of I candidates. pipeline we our platform are our that things for instance, product the mentioned, call think we and to is continuing on where evolve creating

FTXXX that product. already as three the now a has We new engineered backbone with as starting instance, For starting product to create that essentially functionality cell pieces can material. use in of that candidates

So I as think exciting instance solid think things solutions. very think, we as take tumors really partners edited attractive the to example, it's that engineered to is think about think we think where and our multiplexed ability is I candidates going product of for highly highly to potentially and engineered platform, one how do an and our about develop attack is I

XXX-million With respect finishing debate where when can, were you to in -- successfully I in -- were there my missed escalation the dose not And dose. with we hit. we trials the were dose dose cell to were sorry, visits on million completing of expansion midst the at dose we sort in the midst the of, But any per agree completed. escalation in FTXXX, respect or which we to stage, knowledge cells XXX COVID

results about I all excited had the safety going continue tolerability including And and obviously, patients so out second received talked the call, into six to super where doses. cycle strong see on the really we're

it's escalation program. FTXXX just first and I late dose were early. so in way October, to in mean, in early the I respect FTXXX through With dose working we our think escalation, treated the patients we

Robyn Karnauskas

Got it.

Wayne Chu

coming there as we our were at COVID-XX trial. the that became on Phase I Scott such add I active in when trials patients level would situation also to were the rules of restrict midst in to the just institutional dose of escalation mentioned, all that

the in that so have to we've are the been constant on communication ensure been guidelines very being And who with appropriately. investigators trials closely monitored monitoring, patients are institutional and very

with the clinic. and their lab the patients where part, physical actively things to most to and like clinic COVID-XX to cases of cognizant in into come of the that. monitoring to and adhering come impact respect still have exams COVID-XX still unable to we even schedules the to patients clinical to with the continuing contingencies But the sites of ensure have to of worked are draws point for remote situation And despite possibility monitoring are other


Wells Fargo. of Your line Birchenough from next question Jim comes with the

Jim Birchenough

Congrats Hi, a lot the progress, all guys. cover. on to

ship guess different I for other be So couple able as how about that been be number platform versus of patient could how you you just those compare to open talk mentioned you allows your doses sites? cell to to to you one, reopen you're opportunistic And all dosing? therapies. sites opportunistic able maybe as questions. Have sites

Scott Wolchko


the one like product cell more we that IPS think unique with much for monoclonal have. of I advantages to off-the-shelf the antibody closer platform, ability Obviously, truly to an you therapy. -- an a it's have have paradigm

So manufacturer yes, we cryopreserved. already have doses of are that hundreds absolutely

those doses the to We are doses distributor. Certainly housed have redundancies respect some are housed. with at where our of

We have a distributor.

with have Other stocked sites absolutely -- we doses. our but clinical

site. And to so outpatient paradigm treat doses have promoting And patients. being also on sites stored our we're able clinical obviously, for an

we much emerge of doing come we I to and much, traditional situation than face we out accelerate pandemic, or potentially you in for patient it donor we're as were where batch might really cells every this So out where do therapy unique we batch if a cell-based think COVID-XX were run. from requiring and fashion try can in quicker manufacturing sourcing otherwise a

Jim Birchenough

just maybe Scott Janssen up congrats then on the deal. deal, and on following that And

or Just is that there they example ADC. seen same bispecific we've other or as do, the instances, they target? is or your CAR-T protect therapy targets by that the antibodies that the Is get cell make for from the very provision And a individual an iPSC-derived Janssen where it's anything that pursuing where and the leader a priority? ADCs in to naked if quickly there in bispecific is against an there followed prevents then antibodies selected, anything some collaboration? For

Scott Wolchko

be this There's that collaboration have clinically product which in already it The actually validated. might be they a domain creating or of binding CAR a nothing protect or to out a where cell are we NK in bispecific that necessarily CAR-T already using the may late-stage collaboration. may reverse against in true preclinical

Jim Birchenough

deal. Scott one on the final one Just

access the on cell internally use FTXXX of kind they master make You that mentioned bank? to the have with Could that working accelerate you're Do though overlap to at development Fate. assets? of there's partner of they the anything no

Scott Wolchko

to don't it. So clear building the certainly, binding we to handing And it. – They the But have clear, to constructs. access we domains. be CAR Janssen be they us can is use are

we FTXXX backbone? think I headed using that's in were the distinct a you're under see that as product direction arise first-generation Yes, so candidates collaboration a And the possibility. might,

Jim Birchenough

Well, Great. on question. thanks taking for Congrats progress. all the

Scott Wolchko

you. Thank


Your from Cantor. with Alethia next question comes Young

Alethia Young

Hey, guys. or about some Thanks clinical taking my them. the for sites. how potential noticed of additional question thinking One, just on you I Congrats kind you're about I maybe too. curious was progress. trial sites like expanding referenced

So that play? deal it and doing like of secret guess, a a capability? natural is will big it add? interest you it look I'm I lot how interesting just seems Janssen long then do that you you the at was just strategy really the also I there wonder, that what when manufacturing And you much have? piece really think sure the people of that you an And Is one synergy term? what's Thanks. the is move a sauce? with Or Like, collaboration, a think is guys. value like

Scott Wolchko

say, yeah, to going in respect adding sites, mean, clinical Sure. be I clinical to would we're aggressive sites. with I

amount tremendous obviously or those excellence respect centers a to have away which product. Anderson, can Sloan that's one available for opportunities unique delivering centers instance an product that a MD of pioneered I move at have There's competition excellence therapy. potentially with having that the Memorial from CAR-T a is and therapy like we of outpatient the of we Kettering obviously having think of off-the-shelf cell

to we I the we the of potentially given our product broaden think number have candidate. sites of the go that clinical opportunity off-the-shelf to nature

of mean, the think others – I also in our we platform. to see in pipeline see we that hope this there's and that product I collaboration, multiple in our think points respect – With see I Janssen there's we and platform value

we I the just of believe do folks to what sort with I differentiating in in batch this we three, cell and alluded I have do think forward address to very do as next it functionality was of cell And the two, at five that's response notion batch solid that challenging think the I tumors, Jim one five years a level. move we features order edits really to multiplexed population into will four, to embedded engineered therapies. three, think of by

instance use And engineer a single provides advantages to with four, three, as you so think about that just being material single for powerful as able some fashion I forward. cell in going really, starting a five a characterize and cell cell really a think edits renewable therapy

I collapse think into really event. onetime able what of features to engineering being one of distinguishing literally the the that's all a we do

Alethia Young

Great. very Thank much, you

Scott Wolchko



Yigal comes from next question Nochomovitz Your Citi. with

Unidentified Analyst

on Thanks Carly question. is This Yigal. Hi. for for much very taking our

then First your question strategy in you this we and for the data you dose ongoing give in see program? FTXXX longer-term the the context had kind what was of where next the sense trial. a Can just from escalation you us for the as for update are of key learnings

Scott Wolchko

in still Yeah to program. pandemic hit. when FTXXX? we're continuing COVID dose obviously For add FTXXX, for sites the early the to escalation, FTXXX We're

IPS-derived look I it at is FTXXX it, engineered if you cell think therapy. first the

multiple use because to targets. The really hit think is powerful, can antigen novel CDXX receptor, and we it we

And interesting monoclonal using, in case Rituxan, of instance, that FTXXX glimpse I think, therapy is antibody for to first to going combination with so this getting us. be in really

I'd also the of of historical use a a say donor-derived FTXXX that monotherapy setting And the there's the for AML. to cells NK with setting. respect AML is precedent as lot in

NK be interesting respect being activity and of potentially able powerful like to FTXXX cells antileukemic could or in think setting the time the therapeutic candidate and is really in so the instance, given product I exists to, benchmark setting. FTXXX AML, really And a with a AML over for precedent that

Unidentified Analyst

building questions and the potential kind just an on a That's future with opportunities, you about to then you developing product talk partner lines And candidate of once associated the helpful. Got desired around it. the deal with of prior process and Janssen partnering comes can some time a iPSC-derived the target?

Scott Wolchko


the I developing expert a latest and or this to and is not domains bit. on Fate binding optimizing today targets -- and It those developing necessarily I've said little Therapeutics in -- think depends domains it access cancer targets. binding an before, greatest and depends identifying

what really collaboration. as does depend it So, example, to be day contributing an might at on the one partner the

the domain some a antigen level Janssen, least of targets, about, case at of Janssen validated the in about. up that excited at So is some we've binding showing talked they're with

built for an for domain were backbone, And XX binding potentially the it dropped and so, to IND -- construct instance in someone, have FTXXX hand instance, CAR we we candidate validated into and could able a us if construct months. a

that Let's incumbent frame. in a CAR having around just product. pick could contributing which on domain depend a we confidence really XX -- that's months NK or validated as build a a cell But reasonable partner CAR-T a time binding

Unidentified Analyst

really helpful. the Thanks for question. that’s Great, taking

Scott Wolchko



Your next with Daina SVB question Graybosch Leerink. comes from

Daina Graybosch

A the Thanks Hi. for questions. couple.

one half. XXX The when see could you clinical maybe for primarily some might thought we'd if understand but in help you had data think FTXXX, also initially we which and XXX just is first second us see data ProTmune, I

Scott Wolchko


respect So, to a -- I'll sort of with take time. them one at

think ProTmune. say, study enrolled announced we start we I of XXXX. the to ProTmune, with So with in actually I November we With fully ProTmune, ProTmune I'll -- want

through we're of There's sets And four at looking with set, so a GVHD. incidents cumulative associated grade ProTmune has two it. day-XXX where two key data data

fully progressed through our end have And so day-XXX that point. patients obviously

key And transplant secondary outcome. this secondary of the And cell then the key point really captures totality point. stem end there's hematopoietic the end

commonly chronic end a referred survival, so point And to as of so and that's moderate-to-severe, relapse day-XXX GRFS. point GVHD, instance, that's it's readout. And a composite for an end

XXX the stay will blinded day throughout currently study blinded will is assessment XXX. of and blinded day both and be The

until not will So think first math XXXX, when will if of about you day XXX, correctly. that we did I have data hit half all if like we the ProTmune likely

the to to will to respect FTXXX, IPS-derived go patient-by-patient with we not do data FTXXX, With not respect going we're so programs, FTXXX, that.

wait dose essentially of through until We type will then informative an we provide have group patients and that data. of escalation

initiation respect Obviously, enrollment, we some new COVID think and we delays the new site to of because there's have patient be been delayed, and going patient to enrolment, pandemic. with

transparency will we enrollment data. we clinical the disclosure provide for the And the so and as dates more approach

Daina Graybosch

end. then whole Awesome, second my on completely and question the on different -- the

is you whether Celyad that. what mentioned learned you you speak clinic? target, I mic that And new it's it program, CAR-T. to program think can AB NK a to this from close as maybe into CAR how or I For yours take pan-tumor and CAR-T wonder you've don't the the if

Scott Wolchko

because at high level, about this to ASGCT. this disclose I'll at touch Sure. a we're

ASGCT, both at to will CAR T see and in MICB respect data, So MICA with both you cells NK cells.

you'll So CAR both, MICA to it some in MICB. see initial data relates as

cells. its looked respect The With types of NKGXD receptor -- of like a at sort shed. targets I of can to other say, obviously on we've a NKGXD, with given MICB, it's would and programs, a MICA NK commonly key activating ability, lot

familiar one And is very mechanisms I that features all of differentiating think, that so associated is program, is we're that significant of I think T of escape. this one the cell with

in especially also that tumor, of now of cell is the more very more think shedding NK escape potentially one potentially prominent and there's stress of I on exists. emerging tumor prominent tumor tumors. data this mechanism cells ligands escape solid And a mechanisms the is

with intrigued about and with overcome escape. this it And X can that's really and because we'll into of alpha NK we shedding in domain think were program, cell we MICA the this respect MICB specifically what program the to get ligand, targeting we the

Daina Graybosch

That’s very Thank you. helpful.

Scott Wolchko



Nierengarten with from comes Securities. David question next Wedbush Our

David Nierengarten

was you if relapses the at Hi. thinking one Thanks that patients some points, just generally disposition a I setting provide transplants. program. autologous on goal thinking XXX of I been any wondering, NK prevent has quite were This taking study on the -- in how had or more a in And just to for could Thanks. just quick you transplant end or about for the time question. about XXX Minnesota? detail

Scott Wolchko

Sure. you that? take to Wayne, do want

Wayne Chu


medical transplant aggressive of cell an still remains mentioned, for patients lymphoma stem the in you as setting with autologous prevention unmet relapse need. So

so specific And with a study, to respect to the few out. point I think things

selected risk biologic the First, population with defined well immunochemotherapy. high both patients their initial disease, are are characteristics that as as of to by response patient known that's

salvage receive So eligible patients things R-CHOP. on cell like stem And who've followed had transplant. population then immunochemotherapy by relatively poor this. to for and the responses That's come

part poor, these get even they situation, are outcomes because, for short relatively in And to survival. are the and was survival patients, with event-free progression-free able the picked this relatively so population large when survival transplant to

post study among see which results of and whether cell setting stem the are study. in or is addition purpose autologous to points of not event-free FTXXX progression-free the the the survival, important survival of prolonged And so transplant end this this in

David Nierengarten

quick -- factors? for they is because get XX or risk response Or And, quickly a patients, mean, I response complete these didn't frequency number we XX maybe right see next divergence in in partial to they Or, patients completely -- stratify basically, outcomes patients a to with the experience see months? are six sorry, that, the right XXX? they're they number what's didn't or -- follow-up, the so when -- could treated by of with a a potential relapse the you how

Wayne Chu


think and also in one end the points post-transplant I tolerability the But worth primary also of setting. of FTXXX that of the the it's is remembering safety questions. to good study So, understand

the so to safety it's but the part admittedly And characterize in is and patients a number, small XX really large tolerability.

how set if And first evidence we standard of number with that to then expanding not of clinical is of consider better it -- tolerability patients, more would really to are a than robustly there's expand activity, allow us any get depends current on definitely the of patients the determine the the to of patients care. outcomes or in number that whether order compelling

you're than survival to similarly, progression-free that achieve even initial transplant, think, in for patients, measured is, get is about I survival event-free outcomes And, in less immunochemotherapy, who particularly patients year a they than when don't regard response deep a with a year. less these and talking

to a opportunities a in study then expand are So you event-free patients and the the survival get precise to having these that there read proportion fair on excess treat find of that. study if will of you more that, be on

David Nierengarten

Got it. you. Thank


Amin with Jefferies. Our next Biren from comes question

Biren Amin

Yes. Hi, guys. Thanks for taking my on questions. Maybe FTXXX.

you announced And You've with talk can you patients dosed into many patient cell the expand lung did three to checkpoints. about million doses talk In in type? you patients in setting? of maybe cells particular, non-small Can you've that how the guess, about tumor terms I which combination of the that received? background have just led any cell XXX with you patients cancer, with

Scott Wolchko


Scott. this So, is

the in second assume phase three the that cycle. three receive of study last some of were we treated. the at should six All patients patients dose patients least all had of were received some And patients the these eligible escalation you the So the to doses.

it of basket So, the at to and safety or not enrich look dose. the the study a non-small combination, whether hypothesis hypothesis initially the really study look as X did certainly know dose Phase in was We at the checkpoint inhibitor initial study cancer lung tolerability be of monotherapy phase. the for allcomers cell you patients escalation

tumors. inhibitor checkpoint Class for the with that's regulation attacking is we and cell if taking X, where to advantage very to lung bet respect in We of well you literature With biological based MHC NK those a we're respect think have there and instance down is in where unique there non-small informed to out body a significant -- that there's with and lead cells mutations on types it is a this will. to out which expansion, the of respect cancer literature think might

we necessarily practiced dose in space data as today checkpoint the to been in cell able non-small but driven on not we've say would to it's the clinical what inhibitor glean based observed going lung cell with KOLs after I around the checkpoint by in more that including So cancer talking is escalation, inhibitor. non-small cancer hypothesis lung

Biren Amin

CDX cell maybe Can As IL-X baseline patients non-small are enrolling type cancer well will certain have? as additional lung you patients the for just with that? what be color Scott on you or provide required PD-LX support TMB of cancer counts? And study, to

Scott Wolchko


pretreatment we we not are today are selecting on prospectively we X Class doing tumor are so necessarily And level, not -- MHC biopsy.

pretreatment have a that. So must that biopsy is mandatory to get

we will enroll we Class as patients. levels expression X classify to able be And absolutely MHC so

We information. will that have

will that so And helpful us. to be

IL-X adding a properly With sub-therapeutic a that's think IL-X, give of because with we we it's be dose their cells -- ability. activate order best the respect important FTXXX. but to support each NK to giving in we will essentially dose dose to the about And a sub-therapeutic we're excited of activate --

Biren Amin

Okay. you. Great. Thank

Scott Wolchko



next with Goldstein Your question Mara from comes Mizuho.

Mara Goldstein

you hear me? Can Hi.

Scott Wolchko


Mara Goldstein

Thank you.

MICB, and to They're So respect B. the I with wanted ask One MICA MICA questions. stress to sorry only two not ligand.

is if ligands losses -- process. -- just would to are the I'm tumors be what sort relative normal sort wondering of able to that quantify the stress and So to of from affected you're and necessarily compared in broader what group if the there this if of

of can point then right BCMA, about CAR the can field with least going yours just at versus just And so the what us from I'm perspective. on And that us curious I'm where a sort to preclinical -- differentiation wondering, that perspective where -- now. a you're you from show between where is that

Scott Wolchko

days well, presented I'd you With the is FTXXX CAR think Sure. poster to Thursday I respect question to of about hold BCMA, be ask or sort for as week. going two your of this Wednesday at because ASGCT to on

attack multiple -- see differentiating again ability antigens will and features of this to believers of includes of And we are the which at the so you same some in FTXXX, big time. sort the

but BCMA. not unique example do multi an just an one will product targeting, the able for it's the to the antigen just off-the-shelf, CAR combination And candidate think we that of advantages with not mAb with we that's as anti-CDXX in so be instance,

about excited we're so And that.

With And early that I stress cells. NK have ligands. tumor with ligands. respect of because an reasons, by of it's obviously we're of can stress that of the It's cells there about can be agree stress excited activating totally to these cells array NK a interact is sort receptors MICB, NK multiple types one cells are mean, those interact MICA ligands can expressed with that

as on happy certain tumors you if send tumors papers say I'm MICB ligand some on MICA look to expressed you would as at ligand. the certain I predominantly a solid is solid this and stress

that And after. subject mentioned for it's shedding go And It to think absolutely so a is significant which we is as very one is target I we think a And target to it tumors though. that's smart the recognition. solid recognition these mechanisms challenges they as and very as well emerging are of the setting NK-cell of is in tumors have crafty. T-cell to escape that

escape about. overcome tumor, ligands where mechanisms we're can solid the and stress these in excited a these is engage solid tumor way, something super access targeting so the you And

Mara Goldstein

All Appreciate Thanks. it. right.


question next with from Stifel. comes The of Ben line the Burnett

Ben Burnett

I just I'm can role first, Good talk responsible if does what for program. follow-up study inventories talk relates then exactly so a to curious much COVID-XX? can as XXX states just guess, about the the afternoon. much. question. Thanks it so impact the to for company-sponsored you researchers XXX you'd And Thanks as this quick you here? my just for how Specifically, taking that be that trials? are

Scott Wolchko


significant on have your So first. hand to to I second with not on drain inventory the your – a we our FTXXX. question it's respect mean respect I inventory part of with

fact FTXXX we've we done run manufacturing, doses four that hundreds and You one of are in that assume available. than have more should

University With we be how did this support we Minnesota initiate to – team FTXXX know if respect The supply the not about all at came here. we'd us, the to actually of willing did approached to a infectious discussions to disease UMN-sponsored wanted study.

years. been the terrific has Minnesota Fate Therapeutics Obviously a of for of University partner

we the if to can more try to them. to supply that. fight agree do product happy in happy arsenal tool another were we to so than And to we're provide And COVID-XX and

fight to disease. rationale some there for is NK-cells, think infectious strong using actually potentially I obviously

forth of was is the folks us University of appealing to the at clinical reinforce the idea of multiple give this things disease team again think able one to University that putting to at of design being looked the continuing doses. infectious that was the we patients – as I Minnesota the

it's week. multiple cells, all cells the may clinical goes million goes in our starts at patients course the from XXX because And a translation the that intra-patient programs over million study a actually million cells, interesting dose of to XXX XX on learnings oncology a receiving to in are us study week. escalation for doses actually actually So perspective very us benefit a

XXX quickly day cells. all million day So million there's of million four go XXX to from one, day XX seven very where you administration the cells way to

– on of translation time. able able an clinical level relatively is to a we high a will from be interesting short in read we'll period so be very to dose get what perspective And a

Ben Burnett

guess And great I to candidates. too? I of the maintaining table just there a your on maybe is Okay. scenario had. I wanted about just discussions be guess follow-up appetite, clinical collaboration context. sort could for we've the your That's quick of where current That's Janssen they specifically a great. that ownership to ask

Scott Wolchko

mean not is to possibility. going I'm rule I I out. mean anything a Yes. anything

of CAR-T that think instance both going for $XXX specifically to there if just think we after think targets we with been are the we with let's very think we as have in obviously pick XXX the respect an as do cell well BCMA to off-the-shelf paradigm. a world think BCMA, disruptive market has CDXX if you that approach derisked. of million, largely And you well the these I and CDXX as as

as own. those And so again the opportunities pursue today and look change as we we after on go world at it and look today to but can more prepared at our we're than

Ben Burnett

That’s Thanks Okay. so much. fantastic.

Scott Wolchko



from Oppenheimer. with comes question next Your Matthew Biegler

Unidentified Analyst

[ph] Thanks question. is the taking for Matt. for This on Kalpit

XXX, T for is going program just the prevention who be patients? planning therapies? it investigators CAR to relapse the for chemo-treated prior prior to Or received patients are First include

Scott Wolchko

It's likely only. chemo most prior

relapse. patients eligible are of instance transplant have line for these will they hematopoietic autologous are therapy, stem only so and high-risk And are at to for cell failed have for one

quickly. received have in rate but and relapse think qualified patients have deemed only are relapse for at these relapse. high high-risk line, may for on for one So I they of they instance transplant touched The it. high-risk Wayne And is do

will patients these likely not received most so -- therapy. And have cell will CAR-T have

Unidentified Analyst

solid planning avelumab, you Okay. And restrict the based tumors, are PDL-X patient with to levels? enrollment combo XXX switching expression for on to then specifically

Scott Wolchko

studies certainly, of in something of as understanding drive first it know in aspect safety we're part tolerability But our dose pretreatment dollars demonstrate in and a We is the translation of not initially investing to believers going amount a of combination biopsies it. with that I significant And yes, clinical getting escalation. to of -- probably will we're part that FTXXX in clinical and avelumab. big do and these the

escalation, and informative, necessarily of that. not So all that going we're to super is dose to the helpful in kind restrict but information

Unidentified Analyst

All you right. very Thank much. Okay.

Scott Wolchko



with Michael is Guggenheim. Next Schmidt up

Michael Schmidt

of optimizing data were also the Phase Hey, program. CDXX the filing the I programs second the ASCO at on X talked see about CAR-T or early on donor-derived persistence preconditioning in example here was guys. -- coming about. Thanks the such how from just where study and hand think the quarter, IND the up. wondering one the with as some other read-through we But than or like about you for taking my at that you how program looking -- maybe allogeneic coming early questions. it's FTXXX, this Obviously, in window CAR-T up other some things I programs earlier for had think one

Scott Wolchko


-- for other out super it's in instance comes interested think cell mean, the I seeing I I'm donor-derived of what CAR-T programs.

to going fascinating think the I first to at it's -- look at a and clinical get really understand data. be this

at that I things from learn the total also mean, think enough therapy I cell think I firsthand a in certainly programs different read-through in can difficult. IPS-derived therapy. say I studies. think me Therapeutics, we as I donor-derived heard you've the the and don't diversity Fate is this we those where cell from there's think past bit believe is comes experience there's a same

then There's exists of of engineering. lot between donors. with a exists a respect to heterogeneity still there's heterogeneity lot And that

that strategies at the do for interesting instance engineering same And it and some donors the don't But time, even view I approaches. can exist I direct very there a so variances learnings. given as think between and be read-through

in it leave but that, a interested think from I at first really at the So other look I'd are I folks. data the mean, getting we

that the of in able a the doses. to of we multiple are like things give one think idea believer being that, is we of I

doses being potential that PK/PD has the to is that window by to think I drive important creating through some the think in I respect because strategy. right multi-dosing able multiple persistence essentially a give to

Michael Schmidt

think And into avoid persistence but to I about do how and maybe that rejection. that, maybe a goes window of host-versus-graft guess philosophically you

there's in I study? preconditioning how you tested -- preconditioning, being less And longer or I think what's you knockout X none by do guess all. a competitors, stand? Phase are things you that preconditioning, do more will BXM how your this few approach different philosophically at -- where

Scott Wolchko


be learned. to a there's think lot I

community you may to to not -- be cells But as have light into immune we demonstrated true and doses went I'm lympho-conditioning as north And an program are mind, light the a period we cells, same some FTXXX not give we over example. jump can or you think with suggesting could emerge. six generally without cell-mediated the conclusions B-cell XX-day very study a I T that up learn. in successfully that thing to the keep T another necessarily lympho-conditioning, NK that rejection seeing that

from without So FTXXX, the emerges I mind, the I've period what have the significant think in for over cell-mediated to quite a multiple minus minus keep lympho-conditioning give FTXXX we honestly look dose then gave XX-day doses see fact I'm a three day rejection T four you and program and in And immune XX patients and data programs. given we that can treated single optimistic what follow data. next seeing seen days. day on

the So field. I lot to think there's learn a in

back -- I think there's need ultimately you data there's window different But think I use first this. key. and I having about CAR-T to let's days autologous go do a to really of effect the at the field type what to relates it as a during baseline; and avenues think to XX to XX be least appears emerging cell there's profound antitumor as that I think

profound first that appears XX-day activity. a of and antitumor durable I really sort be drive window think window So to to important

strategy enough, I'm is period. dose give necessarily during not suggesting to interestingly the XX-day Now, that one best

with XX-day to to that doses in multiple you best drive may want come I the during period responses. think

Michael Schmidt

thought for Appreciate Thanks Okay. it. Great. the Scott.

Scott Wolchko

you two think as persisting exist to cell day the XX create necessarily you day And we're have patient That doesn't as mean like zero. it mean, three up has the don't just you killing learning that a that at can I weeks one even one. at killing thing weeks; a did that. day same that they I potential have in at potential right, body I'd cells about and for the XX-day and did window on same a can the add a cell. lympho-deplete could It follow lot

it right think I the for just goes activity. beyond window antitumor so, And well creating

You have to doses multiple and cells potent to think going cells. to potent give of you're have I have


line Peter with comes And our question the of from Lawson last Barclays.

Peter Lawson

for Scott. the questions. Thanks, Thanks taking

think fastest? So do lot about and and you've what get of just the options a you itself the as got starting think construct indication around there's to and trials we started could kind of trial a pivotal you platform of

Scott Wolchko

into. that I is think positioned to candidate quickly is FTXXX a product get

Now we CDXX in derisked tumor-associated to I think, can a of have strategy think that we highly have is being potentially have multiple we going off-the-shelf We a target. to at. multiple candidate being show sort able show product efficacy. safety to potentially right do and in look is But we antigens. give it after it differentiated doses a and

So, target's I very I look derisked differentiated product in a at FTXXX we think as the that setting. and have

we're responses. call different with engineered With to about FTXXX, to go lot. think durable solid -- this probably talked associated product tumors; elements multiple have I've But this going a drive learning after ultimately I to I truly a that multiple you're think on

that and going, they're at think, multiplexed deeper I and we as where we're cell into assuming deeper therapies. edited go we're products so look forward And likely registration when take most studies, we

Peter Lawson

of What mean excellence? -- your comment in Great. areas those outside then move of these Thank are sites using areas around I just the outpatient you're trial outside setting. you can excellence you. your an that idea And on percentage of

Scott Wolchko

I mean, we started initially there.

are Anderson. consider Memorial and sort think of MD excellence remotely with a what on but publicly outside so, of that of the Sloan we top getting our I not some of the working like surprisingly, of -- initially activated now some center sites Kettering we're mean, you an are available are clinical would or excellence, these at I folks And started of trial centers

Moores not Center For the instance, of research, across which with at a Diego but isn't work suggesting Cancer I'm San sort is street. hot we UCSD bed cancer right of

for MD more So than certainly Anderson. that's instance community-based

Peter Lawson

adds? when And I then that should non-small effects the about in And any out the cell we potentially how cancer, PD-LX can guess IL-X on we see Great. lung Thank data? FTXXX, think expansion or you. then teasing

Scott Wolchko


I we're uncommon. think That's IL-X, of with to respect doses subtherapeutic not IL-X. certainly giving

therapy programs If of what gives you other IL-X. subtherapeutic TIL in doses think about like we've TIL seen therapy,

exact patients respect I checkpoint to they therapy the I failed mean just the contribution on. think have the given inhibitor inhibitor PD-LX progressed checkpoint these progressed with failed that inhibitor, or that and were or

the gosh alone able rates a But of relative to tease like patient checkpoint That is giving certainly a is said -- demonstrated we'll what look inhibitor be have checkpoint failed inhibitor people you patients resensitize I I therapy. think out checkpoint there response inhibitor. do to that can in have what think again, some already

Peter Lawson

Thanks Great. for so much. Thanks the questions. taking


am turn to to time. I the this Wolchko. back at now like questions Mr. no I showing would further conference Scott

Scott Wolchko

in to near you today's forward call. We for Thank you. Thank you future. the talking in everyone participating Be look well. to


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

now disconnect. may You