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FATE Fate Therapeutics

Participants
Scott Wolchko President and Chief Executive Officer
Alethia Young Cantor
Kelsey Goodwin Guggenheim
Ted Tenthoff Piper Jaffray
Matthew Biegler Oppenheimer
Biren Amin Jefferies
Mara Goldstein Mizuho
Nick Abbott Wells Fargo
Daina Graybosch SVB Leerink
Call transcript
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Operator

Welcome to the Fate Therapeutics Second Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. This call is being webcast live on the Investors & Media section of Fate's Web site 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 afternoon. Good for quarter everyone for Fate the And financial joining results second XXXX call. Therapeutics thanks us Shortly after X p.m. the section Eastern Time Press which on results, release Releases. with & today, we issued can a be site our Web of press these Investors under Media found

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

except this for I'd statements under like to are of that Securities Reform provisions facts, and remind Before the forward-looking Harbor of we the Litigation statements everyone Act made responses begin, historical to conference statements management XXXX. by of Safe Private questions the on call

the results statements. from in company's the These Form as close statements involve the see risks Please was the earnings our after and disclaimer in actual XXXX, the XX, as differ of filed such company's press today, included those to that with risk uncertainties SEC on market forward-looking forward-looking XX-Q ended factors June cause today. filings, that in well quarter statement the issued the for release materially can SEC

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

and the a safety of cell product derived paradigm technology. a Dr. an treatment February XXXX, in Fate of to a stem clinical tolerability is first first is or Joining from a of class trial patient therapy. an ever derived is the multi-dose the study Dan evaluate induced our iPS In United trial and in cell It or investigate a The cells novel today's the Officer. brand-new Therapeutics cell treatment me Shoemaker, of cell States it multiple, on is the iPSC to iPS derived pluripotent the products call landmark in Chief therapy is initiated first Scientific field clinical to administered cycles.

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cost-effective master a renewable uniform contrast, and source in lines products produced in which for at can manner to well be delivered mass significant In and cell are on demand scale are composition, clonal defined be cell can patients. manufacturing iPSC

believe clinical therapies T-cell and multi-cycle Most patients We the therapies to benefit potential has the CAR therapeutic therapy. are treatments source products often FTXXX cell the conveyed treatment a too ever we multi-dose, In patient short of derived single administrating trial, feasibility first are the cell investigating emerging cell field the on including schedule. to this iPS be of class of administration revolutionize lived. donor and can

that including and action. field established immunotherapy, to of cell-based the have such therapeutic dosing. be cycle paradigm demand, the can at products uniquely of per with in multi exists treatment more synergistic optimize multi-dose, multi-dose, complementary treatment to cancer cell we products. multi-cycle such on cell dose, opportunity cost continuous with exposure agents derived over a convey iPS believe potential And cryo-preserved responses delivered weeks paradigm provide Since has may patients repeat months and In the mass produced durable and a therapeutic mechanisms low for combination

to The weekly trial FTXXX therapy to as on doses inhibitor tumors Patients a additional initial label once failed in as therapy. trial designed once activity of combination patients in monotherapy of who approved clinically of checkpoint second an FTXXX whose FTXXX with escalating who progressed patients doses. safety tumors for advanced a three a treatment therapies. of and and assess of treatment The is or respond weekly first three have the following open solid all X dose the Phase clinical are are stable failed inhibitor study checkpoint treatment cycle clinical following to response eligible cycle is the receive

a the arm. level and All of at doses FTXXX that in no an the with In eligible outpatient first May the received serious cells Cell XXX cells three in three Gene per of treatment once tolerated XXXX, of treated Society we dose setting were toxicities the FTXXX Therapy, per and FTXXX-related dose. monotherapy each which million patients in second studies FTXXX weekly cycle treatment the events. limiting patients multi-dose XXX receive well cycle, three announced at first with of dose no All three at were American first was to dose million patients adverse

million have FTXXX patients six the with combination related serious FTXXX level monotherapy with immune first of I dose three and arm am limiting each with received no per FTXXX six treated additional cycle. these treated additional and studies patients In these pleased the in three receive per toxicities adverse FTXXX in six to FTXXX, additional at All of second additional first setting dose of a of to patients with treated dose announce well an level outpatient were eligible in weekly once were patients, no of now at of XXX cycle. million the dose that patients was with in dose six patients events. All treatment second cells we cells the checkpoint studies XXX multi-dose three doses FTXXX treatment the tolerated inhibitor. arm each these were

receiving have investigators reported events patients serious no FTXXX-related adverse by dose limiting been in no To-date toxicities and FTXXX.

the schedule. observations is brand-new of FTXXX these a We FTXXX derived a class treatment encouraged multi-cycle is on given first products administered that initial iPS being multi-dose, cell in and safety are very by

products for patient's dose or changes by the FTXXX cells potential of T iPS of of integral clinical cytokine administered this T immunogenicity activation levels patient's derived conducting as This our the including measuring K cell immune the cells, and patient's the we are the of cells demonstrate robust FTXXX T part cycle, course CDX cells of patient's mediated the the further B program. treatment development To and over including assessment and evaluating immunological an assessment profile a regulatory profiling cells. potential on cells includes anti-cell durability in

provide FTXXX of including the study activity XXXX. immunological the and update efficacy data expect an safety, on in to We second half

is FTXXX platform. first for receptor. is our I pleased initiating engineered in to the Fc express iPSC candidate universal world CDXX clonal hnCDXX our a to am that clinical non-cleavable of a and K or second derived be proprietary off investigation now the and the clinical product are product product it targeted shelf high-affinity from a cleared iPSC derived candidate announce novel from to engineered FTXXX, cell also clonal investigation emerging cell line product iPSC we our master line master from

against vial bag cell FTXXX was for single the and We engineered bank and including master identity, CGMP post-thaw tested and The of cryo-preserved from iPSC doses testing viability clinical campaign. initiation. a cryo-preserved release functional production completed with activity. GMP hundreds ready Starting single FTXXX clonal product have of final were a an product infusion a product in was cryo-preserved cell specifications stringent purity, in manufactured of

safety are refractory which concurrently million, following second and trial trial label additional FTXXX. dose. refractory activity for enroll escalating directed Both will assess doses cell with in clinical lymphoma. once cycle FTXXX the is is stable myeloid across dose study clinical acute arms as of Phase weekly eligible X CDXX dose a an of of XX and B three therapy receive The and is as per for clinically three million treatment are treatment cells relapsed a a planned three levels monoclonal designed monotherapy treatment to the million the treatment antibody XXX leukemia open of who of to FTXXX the XXX of being cycle once doses. study investigated The combination first relapsed of Patients weekly the

CDXX dose a single include at cells initial patient XX per of million will combination escalation enrollment Specific dose. with an therapy, to antibody monoclonal directed

patient currently working are We We believe to FTXXX. the initiate is United enrollment. five there support compelling with clinical precedent to States clinical benefit sites in of therapeutic the

we believe are of assess Additionally, there we benchmarks the which and against can safety FTXXX. well-established efficacy clinical

been AML, cells or release NK derived associated relapsed cell refractory graft-versus-host patients derived of not Notably therapy. In hundreds of treated syndrome with cytokine with NK been have the donor have disease. donor setting

remission in be rates from particularly Additionally, marrow reported studies. have having leukemic cell NK been blast direct complete bone the mediated to to been XX% killing susceptible shown with to in ranging investigator-initiated XX%

to the first perform biopsies to activity. treatment in following bone treatment the post FTXXX FTXXX third insights cycle marrow gain into of additional plan We that dose

Additionally, anti-tumor CDXX potent coated which bind the approved antibody studies mechanism targeting cells by monoclonal dependent ADCC, a antibody of therapy recognized, kill of demonstrated numerous importance have tumor cytotoxicity clinical cellular FDA cancer or NK expressing antibody and cells.

high-affinity binding variant surface have significantly FTXXX have monoclonal XXXV, XXXV, only from all which antibodies shown for tumor-targeted XX% to which with studies antibody hnCDXX CDXX patients the present Fc for expect ADCC. following the CDXX is of augment because improved levels outcomes expression Consequently, a incorporates also in receptor, homozygous therapy. variant that active to novel high-affinity about FTXXX we Clinical patients of treatment enhanced maintains clinical of

complete of monoclonal overall approximately for relapsed As of approximately antibody directed with rates lymphoma, enhanced CDXX X% patients and a agent rates demonstrated XX%. refractory response ADCC and therapies have benchmark response single B-cell

including second and XXXX. on provide patients of We the the update activity expect an efficacy in safety, immunological data first the from study FTXXX half to

The leukemia the immunotherapies with tumor generation to experience those therapy. a limitation respond. patient response clinical Clinical that CAR both and antigen patients single that are of specifically have targeted toward of next in moving are clearly CDXX cancer and And patients of T cells for initially lymphoma associated all we even not case wave cells myeloma cell-based engage that derived designed development first respond T in and against CAR antigens. demonstrated of multiple against BCMA remains significant durability

than incorporating Among target antigen to due the tumor To antigen more cells. limitation, mitigate mechanisms the the reduce one are risk to and relapse antigen cancer simultaneously immunotherapies of is escape. loss regulation of this from generation next identified target relapse disease or earliest of strategies down

the engagement shelf last off and days, CAR new we company's am FTXXX candidate NK universal within first to emerging to for master [validity] our a line iPSC the Drug receptor drug clonal monoclonal antigens application [ph]. potent CAR investigational engineered of with CDXX, product three from submitted Administration tumor proprietary pleased for and and the a IL-XX that with from an candidate associated I modalities, additional combination therapy is novel proliferative capacity the XX derived fusion NK a product antibody functional a third improved announce U.S. is iPSC FTXXX, Food and the cell functional in unique product distinct receptor platform. for targeting cell hnCDXX

additional B-cell naturally cancer recognizing locus to and expresses the activating malignancies. potential D significantly believe receptors to disrupt a cancer other killing CAR allogeneic immunotherapy has to be We FTXXX NKG to as XX And landscape. such best-in-class cells. Moreover, T alpha the function and immune cell-based FTXXX of in convey treatment that for cell innate the

treatment to by showed multiple reported candidate. designed cell antigens and derived to in CAR multiple Anderson, safety the potential been CAR CAR FTXXX and cord doses XX-day clinical Furthermore, NK shelf engage a cells approved over administered has profile. which tumor universal XX It blood cells the substantially malignancies data it be comparable off T product investigators currently NK MD response with to to XX multiple specifically supportive cell patients with delivered therapies have rates from B-cell clinical XX of improved is is cycles. associated a

of a as cell The leukemia. submitted with monotherapy in lymphocytic to monoclonal FDA was as FTXXX lymphomas CDXX refractory the clinical centers. relapsed investigate for several to clinical leading antibody with combination therapy advanced chronic and treatment protocol a CAR the and B-cell investigators FTXXX at consultation for directed medical developed T intend We

FTXXX administer treatment multi-cycle to cycle. a using plan conclusion initial each response assessments We at schedule and to multi-dose, the conduct of treatment

our Kettering of under the therapy and the Dr. of cancer cell with development cell we franchise, T to development T by in CAR clinical NK assert IPS derived our Michelle cell exclusive position the immunotherapy derived Sloan continue leadership collaboration Memorial off our research Alongside shelf Sadelain. iPS led

the targeting expression cell off cell the shelf into a receptor of a derived FTXXX discovered having construct including receptor first Our candidate the and and clonal cell FTXXX T incorporates of T car CAR locus. design novel Dr. a universal engineered by master cell Sadelain. complete elimination T for iPSC products CDXX T of from product CAR insertion line best-in-class alpha Xxx use components attributes We CAR believe is

initiated We Memorial transfer drug protocols manufacturing production support in GMP Sloan application compliant technology initiation an for have to Kettering our differentiation of the submission. team now pilot new investigational of of at

We iPS an renewed collaboration derived for candidates company's Dr. additional of the three also development the years. product with research for and have exclusive T cell Sadelain

having to Additionally, therapy to out. is I Genomic Engineering knocked a cell life-threatening of note off CAR T-cell encoded Cells elimination The iPSCs and endogenous to CAR a of derived Office gene ensure T construct company occur a patent track the am XXXXXXXX critical iPS therapy. disease, pleased the Pluripotent when Number locus Patent recently endogenous Patent U.S. alpha in disease that can of covers U.S. complete entitled patient's granted T-cells gene the an of the foundational Trademark shelf donor attack compositions CAR TCR healthy a into to prevention that tissue. allogeneic graft-versus-host the and TCR the

Importantly, not to is associated limited locus encoded into antigen. the tumor TRAC specific the CAR construct a

over clinical regulatory Finally, our advanced quality have development. as iPSC which thank into at has significantly teams Therapeutics, platform months product Fate and the I past want manufacturing proprietary XX expanded to the

of In to clinical XXXX IND, anticipate cell GMP shelf remains product their the role on-time the fall of candidates. manufacturing schedule supply derived in-house on of in of launch our production in GMP of our the our the addition FTXXX off for and initiation facility we instrumental iPS submission in-house

Turning common $XX.X $X.XX or for share share last financial period common Fate million a of ended net XXXX, second or compared the year. a net of $X.XX million to as quarter for our same results, incurred June loss XX, the $XX.X to Therapeutics per per loss

from $X quarter with the compared collaboration primarily for of Revenue Pharmaceutical. ONO Revenue million was the XXXX XXXX. for was $X.X second derived second of the to million quarter company's

of development associated million period the share-based the for of to and with with collaboration increase our $XX.X XXXX the associated under headcount advancement and pipeline, $XX.X the last growth in in to research RD for development company's including associated activities and expenses expenses was of with primarily product million compensation company's Research compensation an quarter expenses manufacture employee the candidates attributable support clinical the the second the were conduct increase our of to compared with Pharmaceutical. year. The expenses our product ONO in same

year. $X.X G&A expenses for for the period second quarter of XXXX an were $X.X including our the primarily million compared last compensation, million in compensation. employee was G&A share-based to in increase to increase The expenses same attributable

shares preferred which into convertible common five of million. $XXX each of was of were net expense convertible Our quarter shares short-term was of compensation shares of cash under for $X.X and the certain total approximately the second million operating conditions. quarter At expenses XXXX, X.X investments stock-based non-cash million and of were second Common the stock stock end $XX.X million is XXXX, million. XX.X equivalents outstanding cash, outstanding of stock

And call I'd open questions. up to with the that, any to like

Operator

[Operator come Instructions] Please go Cantor. will ahead. Young Alethia The question from first with

Alethia Young

learnings, what Thanks for are think be FTXXX? data the to lot we but and FTXXX there taking efficacy quarter. talk key Hey, throughout my any How talked think Thanks. core the and on guys. a is that learnings also there? I any as more and about about guys all about seen I want head far wanted about expectation bit about mean in we as safety you to could should for immunologic into question just you progress talk as congrats XXX. a readout just little the

Scott Wolchko

the with respect questions, versus slightly in FTXXX expectations the with we answer on-engineered because salvage an have and I'll FTXXX clinical So, at with solid obviously, respect advanced with product least respect initial first NK studying candidate, tumors at are FTXXX setting. we to the to in cell readouts. different is it's to FTXXX patients

this of the at receiving immunological the looking With to enrollment. respect and safety primarily are looking at We FTXXX early study cells. the the at response of patient stage patient

first And looking engineered. with candidate as it's With engineered patient So, at now, has an to experience respect FTXXX; and really we're product where safety. actually engineered believe there NK we FTXXX, high-affinity cell non-cleavable FTXXX been clinical we're It's for FTXXX and obviously clinical importantly, strong the receptor. setting into CDXX in engagement. taking particular really been a a an proof-of-concept is CDXX

been As received donor I clinical been discussed there's NK in there's obviously, the have cell AML have that responses been seen. and of patients hundreds who setting, derived

Additionally, with the CDXX cell of there's killing. NK of underscore importance to monoclonal and antibody of all mediated kinds engagement the therapy role clinical data

would I iPS given through doses an are safety cell so, dose multiple say and in these multiple at and primarily to patients with escalation respect looking study therapy few r with And XXX being over cycles. first the proof-of-principle derived

FTXXX, clinic is cell now clinical were strong engineered the with to initially precedent the therapy into we're we respect pursuing. With that moving indications with an where there

Alethia Young

to do do there's And maybe product? a of need you ask higher may different dose see follow-up, any in a you or can you think that the that XXX, use kind potential efficacy, I think

Scott Wolchko

I setting opportunity with therapy the FTXXX. think certainly AML see in in monoclonal combination the antibody of absolutely and with efficacy there's setting to the of

Alethia Young

Thank you. Great.

Operator

The Please go with next ahead. from Nochomovitz is Yigal Citigroup. question

Unidentified Analyst

combination -- the FTXXX for you Thanks Wondering on [indiscernible] taking AE comment could for further question. our is overall This on monotherapy profile Yigal. Hi. Thanks. if the the arms. comment and on

Scott Wolchko

Sure.

monotherapy the the been The in related at includes total mentioned limiting arm. modest. level treated Checkpoint toxicities million not in at been FTXXX as as million FTXXX have quite in in have I AE no arm the have treated SAE instance That think as XXX dose combination with to-date dose profiles to with both inhibitor. XXX level that observed patients well we've that the monotherapy as as a combination patients for that there's been been well dose

Unidentified Analyst

the Okay. treatment from Thank the the FTXXX you. trial a cycle And patients Have to in consented yet? follow-up us. second

Scott Wolchko

Yes.

patients the receive in clinically of protocol are of flight. both and second arms the the clinical that several first we treatment cycle end eligible part are patients As a to stable treatment cycle at are in have that

first If treatment no progressed three well in the XXX you SAEs. no with the through all and recall first the cells monotherapy level patients in second DLTs as dose cycle as at million arm the

Unidentified Analyst

of savings And Thanks. Great. be us. more Thanks. the one Okay. cost manufactured? on doses from one you which last Could the you for quantitative FTXXX,

Scott Wolchko

say manufacturing runs have we manufacturing have for I success cost our ensure million of drive our these and we to XXX runs, opposed yielded have clinical campaigns also are manufacturing Sure. doses I in for $X early publicly is doses campaign. conducting per scale. FTXXX FTXXX clinical this than per that would true of as about campaign. less to both said And

again, So to not than necessarily roughly, for success for scale, product less per we've driving been $XXXX able dose. for produce

Unidentified Analyst

much very you Okay. Thank

Operator

The is Please from next go Schmidt Michael question Guggenheim. ahead. with

Kelsey Goodwin

Hi. for for This on questions. Thanks taking Two Michael. is Kelsey Goodwin our us. from

in how maximizing about towards the quality strategy how auto guess and I maybe are kind maybe maybe therapies? [ph] and of that of kind and longer with thinking you versus has and your evolved cell you. the trials And of us more remind assurance the in burden control that terms Can facility. clinical you ONO halo associated collaboration of you're just the Thank new manufacturing capacity then, separately, specifically First, partnership now term? [RPSE]

Scott Wolchko

think company's have or to partnerships, cell-based we of not terrific to immunotherapies. cancer approach as With the respect it's We quite has to to strategy to approaches a shelf derived unrivaled even our partnership respect with I immunotherapies. respect patient think backbone the mean the development compared donor Sure. changed. frankly, off with cancer we really

the that stand immunotherapy I I I company cancer I that. will mean and publicly said we building cell-based by are think leading have

for in are I that developing in engagement think developing -- part candidates, leaders are looking novel where in in-partnering or and and we help developing is, product strategies. companies with discovering

in technologies think think we're So, backbone; respect iPS we perform the developing instance, to being. a best the with have cell best for cell how we therapies those human we

to our we that bring larger cell can to which therapies and against. contribute we looking novel partner companies targets for can direct are with However, pharmaceutical that

idea developing we experts doing capacity have are are we or there there and And companies the to pharmaceutical so, are CAR actually in binding therapies contribute our of that that domains, are are target, to the can where which They out monoclonal they partnerships product incorporate antibody very antigens driving discovering into the candidates. forward. interested in types new

to we to at our launching to-date GMP to manufacturing We validation the the opportunity With differentiation runs, anywhere XXXX Final we respect we final product we've we done on think the parallel that capacity the believe facility. of to do the month. have process to done multiple the manufacturing produce pilot of work we compliance we protocols facility. and and getting and based compliance in capabilities, candidates respect and per that between looking are certainly process the doses have XXX have with

Kelsey Goodwin

Okay. Thank you. Great.

Scott Wolchko

Sure.

Operator

is Ted go question next Jaffray. The from ahead. Please Tenthoff with Piper

Ted Tenthoff

industry. Great. the Thanks. I entire to dose XXXX per up little a shocked I'm real the wake that think number, a that's call still

excited see if I'm before any update I come guess that it's going of and I and So, the just facility. thinking. to the visit kind in see again ask to new is your there asked and question

about and sophisticated level, treatment these As cell being a commercialized products more products think become At paradigm. how should iteration. ultimately we there's the into high the ultimately cell and fitting

change [indiscernible] of profiles a really different in think I diseases? far in there's different may huge real products wondering with I'm these the years. ramification how Thanks. But, so fit

Scott Wolchko

what FTXXX. have an an with approach on-engineered started single We've started might we a with some built mean in into I where conservative XXX. consider overly candidate we modality Sure. product

gives cells you iPS pieces pipeline cell different to candidate, the from probably into using multiple aware engineering engineer using the our are third in certainly of functional FTXXX and as capability as unique modalities you we believe backbone. product iPS However, an

will FTXXX different candidate a is We've into talked pieces functionality product have which, of functionality a product into engineered again, engineered it. obviously now about of that four three pieces has it. FTXXX, as candidate different

and things to that to And innovating our platform the involve drive innovation. aggressive proof-of-concept of fairly it's do of are itself is, cognizant very deep how cancer the lends we we I first-generation engineered product a a responses. we're FTXXX. that and think our to forward And delivery of immunotherapies We that candidates pushing one I But, have the in rapid so, with certainly clinical does like safety think like cell-based candidates highly durable product order believe important future FTXXX, in show way.

that very I we two to candidates you into our now, aggressive will number our be studies, how see iPSC we're And have first are the in of us product incorporating clinical edits start in think evolving backbone. we our pipeline including that

Ted Tenthoff

Very safety what of is That's in but there cool. really [indiscernible], was is to the characteristics limit each line? that's number appreciative there Is start to going for knock And time, I to the many to cell engineered obviously, in, knock you improve accuracy of the update. probably could limit be and a how over rate a FTXXX. out an

Scott Wolchko

Yes.

looking certainly testing of the we're under limits a today sort an and ONO mean collaboration at and we quite frankly that level. are think things, our within backbone research we're iPSC of five one I doing at actively where today those I edits six

reprogramming tested the start can it think argument for of you three can edits starting And create to sake with right? essentially can if into about Cell candidate Cell zero Master or Master for have make have and more new be that can frankly, now, scratch, start And editing ground the new edits that it a and you may be and the two approach Master of two you and then it, incorporated Cell want and back validated. to qualified with going and unique three in may into actually beginning already incorporate quite I from be so, bank an Bank take which the one or already instead Bank that of Master a may instance Bank and existing Cell Bank product it an you edits can things that is bank. from iPSC three

functionality. that really back to off and you also iPS new cell introduce restart that six massive Banks and incorporate of one the not then been just benefits and go can to is the we beginning the there to have frankly Cell if exciting Master with quite the master edits, a only of process And ability already but four, So, features starting build will associated edited line. with clonal and is five,

the on has made and You functionality edits can characterize top essentially the already validate that can then of build that. already made, are you and bank

Ted Tenthoff

Great you so Scott. Very much cool. update. Thank

Scott Wolchko

Sure.

Operator

The question next ahead. Biegler from Matthew Oppenheimer. with is Please go

Matthew Biegler

Hey questions. for on guys. progress. Thanks Congrats the my taking

So, questions two had I on dose.

explore multi-dose regimen, upper lower which than seen First different for Still just therapies. higher NK you is of doses be XXX, And a wondering, respectively. my there's NK heard and trials. using. wouldn't think limits I mention in is reason obviously and bit what other why a and the you these product from blood that MD you'd those on That's to if XXX cell question. the And dose I'm first exploring cord in than XXX is the quite we've derived second FTXXX trials one what are adaptive on FTXXX, Anderson I want cell a

rationale So that? Thanks. just behind curious of the

Scott Wolchko

Yes. Sure.

absolute is that, Anderson extends if investigators quite has with University only not a our a in And interested a things Minnesota they're a paradigm. as ultimately, been different data of single think in driven past that including a therapy instance that have the both as on for extend of think the will cells And in over one of they're collaborators administering schedule seen are creating excited that to dosing I'll days but you for questions delivered. MD some a And in frankly my of we've in your one in work NK things limited terms I because limitation single potentially number will maximum we that past of the at response and cell require are I potentially months. about we the answering dose. been of what we're derived PK/PD that think of touch that's a of just that well the and donor the it's can the that dose essentially done weeks dose couple profile in

multiple may thinking from We bit have this but have least may the as being we're our the far, at ability we're again, so perspective, to about I think dose. a someone know -- that push we ability really to conservative you do on put believe we the ability give we have we we dose, forth know doses.

certainly they've not monotherapy. have fair also most scale and cells say have been been we would to to derived dose. the engineered So, a potential donor given I be NK as

really the give FTXXX of that has with multiple a FTXXX with donor is therefore, when cell in more And now doses may lower that combination we're paradigm and therapy. over other be much appropriate be agents. more especially not strategy multiple setting. in doses with may given multiple much appropriate pursuing been that's part doses cycles explored in Clearly for to And derived

Obviously, doing it's we're at, and have the potential we look dose to something that we escalation dose. push will

Operator

from will go Amin question The next Biren Please come with Jefferies. ahead.

Biren Amin

Hi, and for background Scott. taking noise. the questions Thanks for apologies my

should longer want sample platform would the a on terms for solid we if XXX as XXX you term. a tumors? And of move this derisking plans at get from to your go/no-go I decision. safety? So, forward Would your look Or certain we in just perspectives in when get so,

Scott Wolchko

derisking do that have patients enrich this potentially So, event would of a which a safety. a lead efficacy. populations, study, of there as it we look I potential subset in the said, terms subset for to of I at in could to is That think

I towards us I and not yet in least of cells expect in I patients subset are has failed am Checkpoint a NK such The our subset no there would patients although expression at that to tumor the is instance begin of Class today, for future. drive particular here, inhibitor interesting low to near that way MHC to think enriching where interested that the X. has reason failure mutated there very the is is We in proof-of-concept that that for of preclinically

is certain recognized mechanism the Those no tumors about significantly inhibitor class of The regulated. down in resistance of to is in types or T that X fail presentation. That occurs will not antigen Checkpoint whereby of by there XX% MHC therapy. patients be XX% mutations tumor cells is,

However, and preclinically. NK potentially tumors that those have folks types killed be can by cells recognized of shown exquisitely and

And I future and of patients exploring of so, suspect I that particular enrich the patients and patients with subset further looking FTXXX, of we FTXXX. subset in begin for that am interested will very near in subset at with to

and experience proving the inhibitor multi-dose, basket both a Initially the arm safety arm monotherapy is towards big the treatment paradigm. and therapy in study FTXXX or where driving the we're multi-cycle Checkpoint

Biren Amin

response, just for there assay enroll you a is with your MHC follow-up regulation? So, diagnostic down that X a patients on can

Scott Wolchko

Yes.

to expression with absolutely actually being levels. done actually can the inhibitors should a in administered whether in Checkpoint It's investigators patients. MHC respect You those X certain inhibitors determine tumors be class biopsy to by to space advance Checkpoint not or

Biren Amin

just then, in evaluate I in alemtuzumab it. Got to question XXX, with on combination a previously multiple myeloma. planned And think company the

that this still So on plan cohort? enroll to

Scott Wolchko

product our that and for we portfolio the the we -- No. is focusing enroll We of way frankly to efficient most reasons decided directing candidates not cohort. think the the that of in product and And is quite and candidates efficacious. one that on thought a resources

candidate the FTXXX FTXXX. a IND has cell a the as myeloma the example, you months. called file in candidate product -- actually know call express is a developing space. derived let's out six next are that we of FTXXX likely coming iPS for an in product So, we've been CDXX. an knocked will to on for FTXXX the NK cells designed particular line, master in ability we

for can combination And myeloma we the Daratumumab think in space. so, with given therefore, synergistically be FTXXX and

entire space So, chance an best candidates standpoint and efficient attacking efficacy how success we product candidate from and into of the has about myeloma product most indications to pipeline thinking where our in at we in our looked think the that analyzing with to development be target about how thinking FTXXX.

Biren Amin

Great. Thank you.

Scott Wolchko

Sure.

Operator

question next from is Mizuho. The Please with Mara go Goldstein ahead.

Mara Goldstein

Thank Great. you.

Just or or a there MHC. regulation in of aware types either be first specific tumors that systems a for follow-up prevalence tumor in down that the tissues on specific should of? Is we organ

Scott Wolchko

Checkpoint instance to we for and cancer Checkpoint at of inhibitor coming out yes, of has that in Sure. can probably But, so when melanoma. I cancer data offline the and that's can XX% that. Anywhere some patients failed send at look inhibitor the of space, lung between XX% you look you [BX for lump for down MHC lung that the XX% patients when particular instance expression melanoma [ph] those settings significant they've Class X. two at patients and they've looked instance about papers therapy that levels Class and of their looked And mutations] particular at in tumors. have for mutations fail MHC X those of and lung regulation

Mara Goldstein

should of ask you've have of terms that think so I about failures of who Checkpoint patients in FTXXX, trial, we sort the been in far enrolled if And failures? in percent -- that Checkpoint Okay. just on how could the

Scott Wolchko

Yes.

was the the all we've treatment call, patients far first no and we patients the DLT in clear cleared So, arm flight those level. the enrolled -- cycle with and second at were combination on are I those dose million patients if XXX inhibitor in cycle. patients no patients not three Checkpoint treatment enrolled And treated received SAE and the in three have

Mara Goldstein

relates question, if engineered. the is And could and off to protocol FTXXX programs? two safety aware as which between be in Are which I there Okay. between is ask other FTXXX just it to obviously one any non-engineered differences differences

Scott Wolchko

generally mean one is malignancy with in the no, indications, advanced safety, hematologic I in I one for mean and very looking different that there those a terms obviously, is candidates we product of safety But, are solid similar. is profile are setting. tumors

Mara Goldstein

Thank I Okay. All much. right. so it. appreciate

Scott Wolchko

Sure. Sure.

Operator

Jim The Birchenough Fargo. Wells is Please next question ahead. from with go

NickAbbott

you well, team and -- a paradigm Jim quarter. for your breakthrough breakthrough is to This congratulations breakthrough was this on outstanding Scott Nick afternoon. not It's this a afternoon. sure. for on Good therapy,

on similar cycles. So, experience on have it cell Can reported to repeat is what comment you XXX, dosing, you now you for repeat NKXXX? expansion, of have the

Scott Wolchko

seeing made -- mean very like we're at absolutely. Yes, into Sure. that I profile I us the in the sort a gets looking immunological about comment closely of this patients.

So, once those administered, tracking at the assessment just our we're this not directly patient's patient. is response but the the will of of looking deep do to the are delivered FTXXX to for and FTXXX I going product we this -- it's the mean And product very are obviously respect we with to cells cells. that

at we are being multiple for there's And assessment, across cells delivered. cytokine mechanisms for that instance whether so, of looking the different instance that raised looking anti-cell immunogenicity at at levels, looking against are

a the one obviously on NK very days T-cell. cells when of derived so, for the the to cell see X focused to for NK turnover of what T-cell. given sort vivo typically about of NK cell cell. than We in a And is expect that than cell different shorter dose different T-cell. in that's T-cell, a And has and NK what endogenous much expand NK are an cells do. It's cell last normally things you would rapidly behavior instance vivo very expect of NK with durability NK necessarily what than life historically a we not like would respect a half donor is not you The of in the a would

of about seven for be half one is giving on-engineered it for NK we and the in X an by So, would are multi life we days of their being natural separated expect reasons to cells that turnover instance the cell doses about days. NK because

dose every X therefore, days. we're So, a giving

are universal we're I really we at intend is looking the this giving cell to interested a is be we mean course product. of -- though in that what one of things

to we the patient's response are first we the cancer to the dose dose what to in paradigm durable dose this a think be going of is responses. essentially believe so, instance idea And space promote sixth the at multi-cycle of versus able for third those cell-based deep Really important respect to drive we the looking immunotherapy be to the cells. -- to treatment versus durability being super with multi-dose,

just limited. The paradigm significantly we think single administration is

of give CAR sake you if dose the even a cell it's argument. single If persisting for a T

the cells later, when out than cell is XX that persisting of If day XX, substantially the XX, you give different that dose administered and days functionality functionality to you patient the patient. on from go fish X the the

to And X so, deep doses. patient's to you paradigm we in response tolerated is safe responses. where prove experiences clinical paradigm preferred drive just demonstrate out cell those as day at from giving And the that not are and that a do the fact we believe but looking is well perspective multiple a ultimately paradigm to essentially to want going durable

NickAbbott

Okay. Thank you.

So, than expansion you've that for the actually had first NKXXX, the reported greater dose dose. second

So, do that have that are cells? NKXXX data iPSC similarly cells repeat your you I you for dosing the to NK behaving in-house guess tells now

Scott Wolchko

the second our should of that analysis we're now I'll right doing expect you a feature our in half XXXX. a cells. immunological activity essentially of what the of of will significant and mean of I lot be What its part call presentations

NickAbbott

or continue as then, that And going goes, you as close Okay. to far studies? to a drawing NKXXX those you're

Scott Wolchko

Yes.

we that I've XXXX. this respect NKXXX Class of how low we get FTXXX to read think we've to NKXXX likely FTXXX. NKXXX, learning the particular those population of in going that good ovarian respect for said a look continue and studies think, to to the and playground to of talked solid patients towards best study, We expression MHC X the wind that by those and levels In about forward. the patient think on I setting I down enrollment potentially the target with with move and proxy good tumors before, the AML will to will end keep

NickAbbott

you regimens. you depletion can't a lympho-depletion update one, a for some related to competitive different you you. makes just recall intense then, you That I the give varies quickly doing on pass you whether are and reported between deaths. And whether these as repeated between NKXXX us than it had with also more given the studying Can lympho-depletion sense. Sure. just once? tumors are just lympho-depletion Thank intend lympho-depletion discipline Scott, last cycles different And but

Scott Wolchko

Sure.

FTXXX. I'll start with So,

patients We're mean, So, with FTXXX. just really depleting with and language. or lympho FTXXX, any precise I I'll not FTXXX my be

give the than dose what Cy/Flu essentially are giving to a conditioning patient. outpatient lympho-deplete a normally relatively Cy/Flu low We conditioning regimen regimen. of regimen, is consists would conditioning It but an and it's you of

well FTXXX tumor setting, with NKXXX in we to as FTXXX. three as actually setting the In of we and FTXXX conditioning setting lympho the are the and lympho that regimens used the lympho-deplete. using we're the we and similar the ones In conditioning NKXXX, AML advanced we with used had setting, fact regimens, did in different solid ovarian conditioning

So, paradigm be can is we given setting. paradigm an conditioning pursuing outpatient or in that a safely are

NickAbbott

And multiple get that you can times?

Scott Wolchko

at giving of on treatment We're actually cycle. planning the a only that beginning

NickAbbott

you Okay. very Thank much.

Scott Wolchko

Sure.

Operator

is go Please Graybosch Leerink. question with final The from SVB Daina ahead.

Daina Graybosch

and two Scott. questions Thank to Hi. got them Thanks separately. have ask I you. I

wonder If first the they with at halogenic and cells the And the what a more NK KIR killing of you AML. in you necessary for FTXXX The that cells concluded are patients action? through talk or percentage ligands to used KIR their efficacy. lot occur several specifically investigator-initiated if of mismatch is lack cell for to for haplo-identical, the expect you ligands. NK process authors can to I NK do of typically looking was that their cells mentioned your times mismatch KIR phenotype trials the in and educated

Scott Wolchko

Yes.

I you. actually So, would done under with been it's in in this is of work importance a a lot great its doing investigating and our mean and Karl been we're question. KIR And of the collaboration work with there's the mismatch role Malmberg killing. lot a that's agree of area I

assumption. concluded Some investigators think been challenge would I important by that is mismatch that outcomes. KIR done investigators to There's work have much respect just as with patient that

to we're mismatch looking Karl collaborators something Malmberg with to looking to drive respect patient importance at is that with at their respect is KIR one responses. response. ligands and ability probably It's our esteemed in this KIR the most of certainly of and one So, the investigators

to at we basis something clinical studies. it it's part our research potentially certainly incorporate and a go of so, as our forward are on And looking into

Daina Graybosch

your And you the the KIR of ligands cells? profile, do cells, the have on phenotype

Scott Wolchko

No. We don't.

Daina Graybosch

up of how question you if and I think your Sierra, Versant, forward, cell We've Okay. seen pluripotent was wonder platform the coming announcements can of on I NC competitors? induced Takeda. of recent Thank to a which you. out speak And a with companies then sort step different Century to Bayer these Therapeutics, stem compares second track. other

Scott Wolchko

and try kind. I'll be

platforms. My are still can't honesty, for just in Therapeutics, third to to all an technology, very of aware therapy. development of not their it's early I'm what to filed IND I So, approach detail Fate our all. cell obviously, their I we've in their platforms speak at mean, and iPS iPS cell understanding in much compared platforms their derived

cell tell will to therapy. expect to I there you be I multiple different generally iPS derived approaches

very of a of essentially our features of the be cell clonality We that single Bank. one -- essentially to respect a will from Cell fundamentally of competition that to preclinical Bank, clones create important. is down think believe essentially analysis engineering with other against clone racing Master instance for each selecting I single the and platform your getting which that differentiating you level Cell Master

instance create clones. when XXX, compare of XX, XXX, selected been Cell starting XXX we Bank, clones a for Master XX, populations we mean I commonly that already XX from have

And create systematically step those clones so, that And down in to clones your essentially your where intended that advantaged. Cell that as clone are against further think for actually we each product. you we and is life then, production Bank get to what to a you because super serve the step clones take we basis cycle Bank a to smaller and tell Master throughout you each race we race of set your use Master can that of want Cell against is critical out absolutely other I entire that other figuring

resources, critical. technology experience, I human property clone will that all become goes hurdle in know-how pioneering that this that regulatory advancing we're technology. given selecting absolutely believe And intellectual into a is so, single cell the And actually do iPS

Daina Graybosch

much. you Thank Great. very Awesome.

Operator

comments? closing And at this time, are any there

Scott Wolchko

to derived giving iPS today's Thank attending for speaking on [indiscernible] more future you everyone you you and cell forward the Thank with near franchises. our in and you. call. updates shortly Look

Operator

call. Ladies for participating you and in gentlemen, conference today's thank

disconnect. You may now