FATE - Earnings call transcript Q1 2021

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Operator

Good day, ladies and gentlemen and welcome to the Fate Therapeutics First Quarter 2021 Financial Results Conference Call. This call is being webcast live on the Investors section of Fate Therapeutics website at fatetherapeutics.com. [Operator Instructions] I will now turn the call over to Scott Wolchko, President and CEO of Fate Therapeutics. Scott, you may begin.

Scott Wolchko

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

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

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

Dr. Wayne will IPS-derived to for interim our for franchises, Bob our clinical including Clinical Chief clinical plans disease off-the-shelf and Senior each today’s Officer. in NK on Dulac, in our B President leukemia Development acute plans our Research Chu, highlight of our and myeloid cell malignancies. Chief our share Valamehr, and progress and me Officer; Today, Financial programs Joining we call data development; Ed Vice of cell are

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goal NK was Medicine and field ex these Translational Director Deputy now transplant. cell the Drs. with we excess studies NK clinical to Vice many and Sarah the Miller in therapy early studies of cell conducting the and XX% NK NK while of responses therapy rates cells using Dr. However, and significant limited Minnesota in donor academic patients cell to Therapeutics. are IPS-derived interest studies, and Center, comparable the challenges the with refractory of Masonic at Miller response patients Miller, of Professor back our University clinical University investigator rates Medicine, bridging cytokine Fate believe cytokine-activated to have of of a XX%, Cooley. Senior recently including therapies, were donor of Cooley And single-center off-the-shelf by in vivo run of time have activated in leading blood advancement vivo AML emerging peripheral shown has Cancer of NK of ex significant Cooley, dates at to Drs. at investigator-initiated relapsed In toxicities cell therapy. to reported, is Minnesota President, approved treat conversation who In therapy syndrome XXXX, including Jeff with Dr. been respects, release cytokine XX%. in

and For resembles donor patient. administered receive like process. from a current Patients donors specifically NK manufactured of example, the paradigm hospitalized, are lymphodepleting cell chemotherapy are to intense NK cells are that for therapy and the transplant matched

first monotherapy Phase cohorts study X per effectively which progression. XXX numbers enrolled while without patient with for AML. and to and outpatient cells, the cells of potential to dose are And a in the X programs XX demand Phase and to The billion remains high contrast, cell disease of many second cells of study numbers at setting, dose. per excess million IPS-derived escalation XX manufacturer, is of of million is off-the-shelf ongoing a FTXXX efficiently patients risk cohort administration such per of cohort treat dose are the And as million dose. has cells as dose and dose, and available the The cells of of ongoing products, in on NK FTXXX have first administered large of are in be XXX often to with the enrollment dose cells necessitates million patients dose. weeks In third untreated monotherapy of patient NK is large matching several in therefore FTXXX enrollment our and complex oftentimes the very FTXXX Additionally, per required achieve with responses. production for

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also daratumumab effectiveness impairs targets cells the myeloma which CDXX fratricide, it cell cell effectively induces death, While significantly expressed and on of induces NK ADCC.

will cell is Collectively, addition, and function. therapeutic patients preclinical a FTXXX daratumumab function the at commence Enrollment suggest myeloma, potential XXX therapeutic activity cells of In cell observations benefit impaired NK per of NK maintaining million further with of often in in numbers reducing and dose. with daratumumab. multiple clinical combination potential

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to dose Additionally, and single following therapeutic the treatment protocol maximize multi-dose includes infusion. the regimens days index assessment both during first the of XX

initial the our of during As range are An in treat And potential about NK making update, I our in therapeutic are solid cells which are anti-tumor shown cancer to mechanism antibody patients ADCC, quarterly is last free a exploiting off-the-shelf of tumors. kill pleased improve candidates. has cells and with a NK strategy and multiplexed-engineered which us product progression building enthusiastic potent tumors. we of with particular bind we to to interest survival is mentioned of which we cells progress recognize, coated wide been by solid the pipeline

X on anti-PDLX the in third shedding expanding To currently activity pleased initiate half this cohort monoclonal And FTXXX that we PDLX therapy. weekly of for Phase cells, optimized of avelumab, month, end, regimens, in X enrolling investigation EGFR, trastuzumab the including impaired, to of including in the the cell in depleted ADCC target X I this expect antibody days of FTXXX tumor FDA clinical which are with in of patients our FDA targeted consisting allowed augment X combination FTXXX with are often of capacity strategy. tumors. we solid of today number can each the receive significantly those of patient’s once cycles, of product clinical treatment combination many is monoclonal the independent in functional cycle to our Under XXXX. tumors. Last application announce of the intend array an off-the-shelf compromise associated inhibitor and dose of HERX patients allowed eligible antibodies with for competent marks that with initiate the platform. checkpoint FTXXX enrollment treatment to IPSC study However, second we targeted protocol, PDLX. ADCC the therapeutic FTXXX that infusions monoclonal am We for potency solid NK to a cetuximab, significant in HERX investigation by up our IND are are This X NK and or each currently the of limitations to avelumab. through XXth administration of of EGFR-targeted antibodies, CDXX believe an lymphoconditioning, antigens, IND patient and the ADCC an with combining clinical We outpatient therapy. can approved

study a ProTmune. would the patients, of thank like take moment in I and who investigators Finally, the PROTECT participated to and sincerely caregivers

allogeneic our meet resources stop efforts endpoint study all quarter first we cell call We intend and its with to disappointed further disease stem of prevention of share of community to curative results. to versus the will potential attention study full cancer focused our patients. announce transplant immunotherapies, are assist broader like the are clinical Ed pipeline for the to following our results host transplant turn graft primary their that acute of off-the-shelf of the the While the to PROTECT to continuing we investigators highlight I PROTECT on ProTmune. not deep in IPS-derived development our of financial would over now and allogeneic transplant and to improve did

Ed Dulac

you, Thank Scott.

expenses The our to expenses and an first compared with Turning for quarter share and Janssen year. year. for headcount an million XXXX million General compared administrative employee compensation, is in quarter of $X.X financial and with attributable same headcount XXXX is current were Research recorded value last the operating based the to primarily $XX based ONO stock, three same same on last benefit for milestone milestone and subsequent first be for for T owed achieved to share compensation our expenses IPSC for our to Revenue IPSC with to revenue Memorial to in net total was $XX.X million have in and XXXX In the payments and for contingent may associated the expenses Kettering. The $XX.X milestone from were non-operating trading $XX clinical fair R&D quarter of including product and $XX.X of expenses. clinical collaboration the amounts milestone the $XX.X million derived Total was $XX.X $XX an expenses of compared the million, the increase G&A are to with cell first compensation. first per aggregate our million the quarter, from employee payments trial In million, $X.X the derived results, payments of of or the quarter million These were increase a up non-cash currently to cell to $X.X share. the been expenses the was derived year. MSK, of collaboration million candidate, up to ranging based MSK. in with increase period including we last primarily a period first owed million CAR T event, to paid in XXXX common no under values CAR development Pharmaceutical. associated $XXX compensation, increase share costs. certain in in in based our Sloan non-cash attributable period quarter compensation, company’s

We value in currently basis, liability million will a stock, this a and our we the be whereby aggregate common fair re-measure non-operating income or we will recorded common in changes million $XX completed issued of valued offering quarterly public the In a expense. earnings as X.X in shares. at on January,

stock, outstanding certain now the call million conditions. shares lieu In investments. stock the under stock of quarter $XXX issued XX to questions. million cash preferred with common up The proceeds convertible X.X was which of like is million outstanding I first convertible equivalents would net into from cash, of to pre-funded was million. common of were warrants. each The we approximately addition, XXX,XXX any open ended of in company shares $XXX and financing the XXXX Common five and shares, stock

Operator

Instructions] from Robyn Truist have first [Operator from Securities. we And question our do

Robyn Karnauskas

question Thanks the and for It’s so Robyn my taking much call. Karnauskas. on

your give week, data you patient How be sort updated with treated AML. about we updated of you Maybe many see, call, that lot do how FTXXX. us the strategy think and of some talked many that baseline. FTXXX And you patients and how you about will in how color with? a will coming, doses we is talked on you on the this then So next – have

do of And picture, And how the do set big we sort Thanks. you for? this digest how expectations data?

Scott Wolchko

Sure.

a event So comprehensive from we now. mean, I Robyn, will have fairly

Thursday. next its think I

now, from comprehensive have days event. will we a fairly eight So

historically has been with treatment cell We done AML. will walk through respect in NK to what

preclinical will of for We a FTXXX instance then the some will significant Wayne that history we walking to detail provide And have have on the patients results seen spend through FTXXX. the time including treated. with that comparing amount we of FTXXX,

you You see will will basis. on detail patient-by-patient see patients a on – a patient

the on see and each will we detail And every providing So, for baseline patient. you characteristics. plan

You will see relapsed refractory. or whether that is patient

will recent therapy. You most see

with You And each will each will patient. with see patient. see activity associated and then and importantly, and that for every instance obviously risk you anti-leukemic associated every responses profile

in tremendous it to – basis. And be of amount on There about be patient-by-patient will there detail. will expect will we that So, very a in include transparent be a total…

Robyn Karnauskas

solid you that’s And more with forward I mean excited I there, strategy for clarity big that? in about am tumors, going the one

Scott Wolchko

cytotoxicity responses. addition solid doing though, for absolutely, Ultimately, antibodies we what What tumors, myeloma, in a in CDXX as are of doing important mean instance utilizing or in compartment or NK that is stepping That’s part designed evidence are one. And cellular And step ADCC is think whether Herceptin, Erbitux, think to monoclonal can for we are know, by there in with there. moving of synergize play instance, augment multiple of not which as We stone. are we that cells think dependent we set solid on is in of increasing optimized is that to FTXXX a ADCC, really we investment we antibody-dependent think initiate actually we in And fairly our functionality. ADCC. are cell that based a suggest in avelumab think their clearly FTXXX, coming we by our for you we compromised. obviously, are of being that where antibodies tumors. there substantially to with Strategy with monoclonal instance patients tumors, monoclonal conviction a cells solid in others. on exists plenty now that engineered be tumors the today checked wave mechanism broad solid NK started within that I NK And across obviously, of essentially improved would to action it into the lymphoma, CAR are that role antibody,

recently are We year, IND while CARs engineering we building of MICA/B thing of the solid same We stress second off emerging addition, in instance, in where for will be in engineered half have into targeting core against the product first will a we engineering FTXXX we solid in BXHX a product tumors. that for Janssen backbone, a our strategy. exact the presented the data cell a CAR the candidates have NK doing this expect tumors, FTXXX And against collaboration the CAR ligands. tumor backbone as first IND, under actually solid be

Robyn Karnauskas

how guys. Again, about you you have I so to much. down. I thank focus all many products Alright. me am it. mind writing have you appreciate But different on. Thanks, them blown

Scott Wolchko

Sure.

Operator

have do next Piper Tenthoff question from from we Sandler. And our Ted

Ted Tenthoff

the Do Hi approaches this event guys. different bit, going I on cell little datasets. Thanks do that have kinds so little of appreciating there much more be cancers color sort you. more you an at? Thank the kinds of with a these where in tumor is envision certain and combinations? Do MICA/B, for we your us With played thinking taking ultimately give be want ultimate later expect out? therapeutic solid will better that that ultimately playing how bit product like different types this you of may on see you the year, follow-up question. are the all side, a to different

Scott Wolchko

engineered a be strategy I us think early in NK may that breaking have actually for tumors are amenable it’s to I with certain to there therapy mean since therapy. definitive cell tumors I generally, solid cell an think solid do more we are ground. multiplexed new Sure.

are in recognition T the cells talked have resistance NK to there or tumors that cells. of system, various instance, escape mechanisms utilize immune solid it’s that whether the We for past of

T expressers class more of of recognize mechanisms the Because can to there MHC works the are And instance, tumors. And exact type the resistance these X. attack. is an MHC in class MHC no loss That’s that an of the down or often cells for Again, presentation recognize. NK cells, cell tumor tumor high cells cell cells that regulation times where is X. through to actually can X, of antigen longer down-regulate that ligands. NK that stress One of those down-regulate significant the recognize class for cues fact of

their shedding a clearly role is or going antibody. of tumors. is think, there But And used stress early with antibodies also really in addition, is and with biology So, in I MICA/B one combination solid ligands. ligands product of on monoclonal in it’s NK be fundamental overcome are and mean, with of particular that of area cells. we interested to successfully, that candidate, for mechanism I part in think monoclonal stress And molecular ligands the to I exists respect are to dependent. and solid often stress action tumor that CAR down-regulation even designed key ADCC, since NK resistance cell

excited and respect so array tumors. with really solid to monoclonal antibody And combine being therapy instance, FTXXX, we of are a against able with broad to that for

Ted Tenthoff

more to excited the am you. I year. and Excellent. data up events Thank coming this

Operator

from do we our Alethia Cantor. next from have Young And question

Alethia Young

sure. question my or to question, looking for on kind a after just maybe single it’s congrats and next week forward guess dose that progress Thanks just guys. taking philosophical the a I understanding how to wanted that for all Hey, and important of practical I durability of and a the can about…? perception a bit a this it is or datasets kind data other little then just kind also, as target well. versus that’s that of talk of about you PDX, better PDLX set am And curious upcoming like having I a and

Scott Wolchko

avelumab. tumors. the up-regulated on we to in exploration avelumab, was itself. obviously obviously solid with Sure. antibodies and respect are question. We I I place early it start of the will last right But start. to mean is we doesn’t monoclonal with started the It mean, with PDLX started combination because with tumor

and it could doses, opposed mean, of at With combination means tumor on begin differences to provided exploring to a and NK expressed instance, that target are doses. again, PDX. treatment with for as one are treatment schedules, cell tease might experimenting least respect we dose, between something So we is with that’s out to that exist target regimens, by I to a we six the whether a schedules this which the durability to thought up the whether that’s in avelumab, different

answer too I think know to the that early to question. it’s

hit when system to ability, of deep of we through there again, reason two, going cell needs window, is function, that’s that there that the for our you or the I the first weeks, a is for it of that be therapy weeks, may respect going tumor anti-tumor changes things a lots data be window believe a where especially is properties, way first multi maybe administer weeks, to today its hard. that cell to to is two a say, period cancers, emerging, aggressive really weeks. durable tumor aggressively you that six because whether is durable belief four think, believe But I maybe And also that of killing to kill would that’s a is attack lead that deep I patient, with fundamentally, the think would first kill. there time, need best drive two six the to four And responses. we where into that the period dosing. the that And profoundly time

likely within belief strategy strategy. targeting a dose that do the is most And to finally, the strategy say best believe activity, administered change cells really be to going we maximize similar And would and because strategy. to patient, our is to effective I multi be is going that, patients so the the multi a that to

Alethia Young

helpful. That’s Thanks. Okay.

Operator

from And from Yigal we question next do Nochomovitz have Citi. our

Yigal Nochomovitz

the much Hi. Thank very question. you for taking

that to are correlated for therapies and of therapies IDH inhibitors overall more you survival CR recent based remarks of AML FLTX approved and measure Following obviously your on some mentioned the alluded with as narrow on improved such approved prepared – targeted AML, CRH. the were being

opposed nuance? in So cell as you specific targeted with CR should on discussions is I have as the wondering, just had be focus was therapies therapies, the to respect the and case any the to reason FDA on ORR any this with there CRH for

Scott Wolchko

this at FDA any discussions not Now, point. the had we have with

We the have platelets. ELN versus requires to And to an what believe can interesting require full We actually respect recovery gold a is Wayne standard. are XXXX we than it in criteria of updated jump be an neutrophils, maybe think higher ELN. or is can We CRI discussion. the using with believe criteria, We of does CRH CRH recovery CRI XXXX either full either. CRI. not CRH. under using bar

XXXX actually you to And we may criteria, know, believe a don’t ELN that. the higher bar want Wayne, comment CRH. under CRI is I on than So

Wayne Chu

responses comment, the on objectively, one think, mean, yes, mean our are we I XXXX I just based assessing certainly criteria. I ELN So

indicators the of Phase only because study, think we responses with to very as in like – are I the of X that, confer on approvals, are some specific clinical we And the CRH in early important some to early CR that and was of not as composite path endpoints where the We recent Phase early X example, fast CR it’s escalation, of registration. benefit. based activity We CRH. at of dose we to inhibitors aware look the might are as for IDH part holding approval emphasize are

response will CRH. further and apply some our just of little set of enough certainly, at then would opportunity allow the this bit of response as about the as So, particular caution committing relationships, get matures, But data other get understanding we to the us between and more we patients, refine a I a relationships to when survival game. data, early durability even these stage criteria some criteria and like we

Yigal Nochomovitz

you very could is on can remind XXX, much. question. XX XXX and you also cells, you expected and myeloma one other commented the three-fold lower had in million to for Thank you dose why if XXX whereas dose But cells, explain in just the XXX Okay. its us, at the for past. starting Maybe this I is what million going for just XXX? starting have be

Scott Wolchko

Yes. read other and too into it I much experience. just time wouldn’t than

derived you at CDXX, we therapy, was that If the the time with go FTXXX an very experiences IPS experience. FTXXX, back, about clinical are little engineered with obviously, initial talking

start and at XX And started cells dose. we per to so proposed million

build therapies, more As our we derived when with gotten with submitted cell including we we and FTXXX. up doses as have have much NK IPS so quite time, honestly of are gotten profile experience the as what safety seeing protocol well advanced FTXXX, our we at and comfortable higher clinical over for

years, million a with we do XXX history, have per safety at the with opted going dose. all given our start cells X dose comfortable was platform to Now, we FDA back higher And the that.

Yigal Nochomovitz

Great. Thank you.

Scott Wolchko

Sure.

Operator

And Yee question Jefferies. Michael from we do have next our from

Michael Yee

expectations back We on to Scott. progress. questions. had the AML. on Hi, was two One going Congrats

rate week some that data limitations have I right seen. that cure bar the about for have fact about previously guess how some as next programs. you well. XXX to XX% to has that been literature, to various XX% the In those of you the with You and will talked said XXX context think into for have Is put

So So question Durability also is that and be maybe you question a comments Thank CRs. summer, AML. we important. maybe the there lymphoma us have that contrast I is in prior the be is around and help X XX% And similar two two question ASH CRs, those is compare you. one would Can how the is had seems XX% you think and programs on laid And durable durability? expectations data so T at just out. just make CAR but versus durability is important with some you around to a given CRs, durability? expectations understand to only that know

Scott Wolchko

Sure.

FTXXX a the I I experience of I natural in that derived obviously, for of think rates. starting have with to studies mentioned going to therapy. cell have XX% I NK yes, XX% – to donor with is or be I lot think AML, these center cell historical – compare, And in NK FTXXX therapy, response there instance, think sort So, comparison. the interest trying with derived academic do to understand desire single donor as XX% shown do in

significant I on derived paradigm I that cell there of have pursuing. NK existed them. therapy are versus differences that with have touched some donor the And think we are

the the right different. regimen significantly about talked have lymphoconditioning just top is off We

We have a for lighter significant patients has therapy donor-derived conditioning. We like give – we such deliver the transplant been hospitalized. product paradigm that outpatient. are Historically, cell NK lymphodepletion the

comparison, to That So think said, bar therapy the to NK I potentially the differences. determine I XX% focused see do – is actually I not not comparison cell we am I XX% reason there donor understand or do I whether the derived with right that’s is product. the is think because on natural have a

on about, past that made rate the where or the the approvals call X has back Going the the unmet in comments to mid-XX. given response AML my somewhere high-teens between some approvals there it, have years, I need, let’s been X been multiple recent in and

I gosh, the at so XX% am And XX%, on I looking therapy, it to I of in a cell about we think into at registration that can response focus in be am the when context have Yes. I do that looking am a donor-derived the that rate advanced study. that’s – of in of NK context actually AML. thinking not bar product And how I actually

product, is will better with we’ll look pre-clinically FTXXX about obviously, it is pretty see have it. have upfront been I asked, and We respect share a data people FTXXX the to FTXXX. When pre-clinically. just

clinic with yes, a are win, With bit to FTXXX. to share that races, data it that XXX head to out of And initially. XXX in provided and XX to much be will that. head XX interesting be or encouraged There is in lymphoma, more ASCO always we to them to whether XX little data. respect raise update we robust a in plays respect not, have you at will ASCO times out of see the If different going

I The of think question. the a is a is response, durability question. I think durability fair fair think I

a think that is assess. still I early bit to

even for – top period not short of are through still time. level speaking we not advanced and relatively study at are patients a We are even dose the the yet our only on

durability a will clear by ASH very think plus of rituximab. of view I have FTXXX we

Michael Yee

Great. you. Thank

Operator

And we Peter Barclays. next Lawson do have from question our from

Peter Lawson

so Scott. Thanks much detail. all for the Hey,

Just for guess to that around to in are a umber? response going CRI bar of response or XX% is AML, rate I response that rate the more question at just back the ORR Mike’s you CRH rate on or or AML focused XX%

Scott Wolchko

extends patients mLFS of over patients of described have is CR composite XX There released statistically survival achieved in a out to was It’s mLFS XXXX not, survival I between comparison relapsed using CRI, very a non-responders, months. a venetoclax the that just referred ELN clear CR there was CR, I made CRI reference is and of a that benefit that published number actually versus the where and is refractory those that versus I interesting groups, paper CRi clear that did criteria data the AML the benefit, two significant that mLFS.

Peter Lawson

CRi more am versus it. I just high I Got high content guess be, gauge… CRH, Would a with to you trying

Scott Wolchko

have two is where ELN not agree in criteria. are of the XXXX CRi. It’s on on the viable. There Both existed part products them response is been CRH. CR CR there CRH achieved of criteria based have originally different where are are approved of criterias. that forward paths very There XXXX. I also part paths forward approvals been

Peter Lawson

to appealing other you. or… that to Thank – using just around through you other really methods the bone deplete not your Cy/Flu Good. marrow comment ways then And are of thinking

Scott Wolchko

Yes, yes.

question that’s what question, around with is, Cy/Flu of a Cy/Flu open is lot speculation cell is, where what of to don’t is a down comes philosophical Cy/Flu? there any effect. purpose question a a I has this think It an on think therapy. the multi-factorial. purpose the magic scientific to think, think has but question. therapy, I biological There probably Cy/Flu of and Cy/Flu is to cell delivered I and I be

One instance, within result biological effects of those as of the significantly for patients is, cytokines increasing a Cy/Flu.

support we at ultimate in we Cy/Flu reasons why the for instance, are so look into we are ways, think we ourselves. and is cytokines of cell the as important significantly can for very think therapy is where paradigm think exploring it’s that And do in reduce about one what forward looking and patients, interested I actually I engineering and

Peter Lawson

so Great. it. Much much. you Thank appreciate

Scott Wolchko

Sure. Sure.

Operator

And from America. Bank we of question do have Tazeen from Ahmad our next

Scott Wolchko

you mute? are Tahseen, on

Tazeen Ahmad

Sorry, hear now? can me you

Scott Wolchko

Yes. can. I

Tazeen Ahmad

Excellent.

that. about Sorry

Scott Wolchko

No problem.

Tazeen Ahmad

Thanks for taking questions. my

bit For and drill in to an XXX, little I as pursuit XXX the into indication. wanted just of a DLBCL

many They Therapeutics. received across had second then ADC obviously, the are the NK space more all to a cells about paradigm? MorphoSys so of doses NK last been just has get And of are the wanted Thanks. how different see Can drugs there how cells of number Genetics that is from thoughts the opportunity your what and your could recently, you where you what’s fitting to for receive? in most the question a general, potentially with highest has patient the and from strategy view but into doses number Over year, DLBCL you re-dosing treatment overall to you Seattle approved obviously companies pursuing, patient potentially mechanisms, far? I us in your program have remind any in

Scott Wolchko

Sure.

tackle last question I first. the will So

we and was gave month, assessment. lymphoconditioning. lymphoconditioning, therapy X by X, X. outpatient this off X and of to safety have days doses and most – and number Day sort we Day X, actually we And of then to administered that X, have on reason We followed – the experiment FTXXX. XX a started of actually we maximum a for And without actually Day of ran was patient first is Day doses that this the patient the where we XX doses re-dosed X the FTXXX, FTXXX with So, weeks we next with goes the did back

that any emerge, see the to be of building patient would in level And doses cell at would initially a at. and not some a one multi-dosing to did patient would other could product not you assess profound were form, candidates with about have We or tolerate form there up administer it rejection we be whether up that to there XX And not looking essentially the X allo setup instance, cell? been a that as reactivity outpatient think not mechanisms dosed immune of to arise. was our that was CRS FTXXX. FTXXX. over early so And days for things experiment you would and would seen for unmatched of could we Would patient following has essentially that light because doses. a that seen lymphoconditioning was FTXXX X that that entire be, of very That with with instance, the that we date. to have

T-cell am our line started NK cells to we a – clearly, single that given where that and we have what as sort combined that DLBCL and We response there dose excited of we where safely think think generally additionally, we single But position lines a really failed to they rituximab. does that have X if within opportunity to re-dose a cycle. respect tolerability rates great either relapsed really period. go about setting we opportunity speaking, and continue rituximab in doses cells, we think With out whether are mean, FTXXX, early I effectively landscape, in XX-day if CAR demonstrated the a patients can show of confident cell and rituximab, dose T it with of is about have sort in to third about over terrific think or like candidate we we where lymphoma fit certainly of have with we repeat to the re-dose the there is we really ability up have there or lots line FTXXX. ability we think compared our synergize, Now, then a discussed, differentiated where opportunity does they have for And with patients think seeing safety with engagers or given therapies, it to seen are we product to have really we are FTXXX, being profile FTXXX with a very instance, actually FTXXX. I B rituximab here. can I you failed are feel multiple

Tazeen Ahmad

you. thank Okay,

Scott Wolchko

Sure.

Operator

from have next we question from Michael Schmidt Guggenheim. our do And

Kelsey Goodwin

is This taking for question. for Hey, on our Michael. Thanks guys. Kelsey

now other of guess number then quickly for be in that I Phase First, update approved and just launch provide done treating maybe are guess guess, implemented? possibly protocol And X insight could case I I XXX file where that before maybe you an can you chance trial is the could there kind amendment the how patient? single fact is dose? and point what into the can needs patients? study this In And into provide we gotten in has that for more read than it. you patients that proportion that of any XXX some be on you maybe second you. there start the you words, at the to-date there secondly, you or to stand still could Thank or That’s

Scott Wolchko

Sure.

First question first.

It’s of by to with protocol protocol it IRB June. the we submitted. can call the let’s and the believe So amendment, approved respect active, amendment, be end

opportunity are FDA We on comment the to giving protocol. that an

the multiple IRBs. to think position schedule treatment to multi-dose by that June we taking with a we a are of FTXXX. respect begin protocol We end implement maybe in to to And

get and time think file of on past one that we reasons have this year have than to disclosed patient one the administering did to clearly last to to that taken we with of we and more some experience is clearly amendment second the I FTXXX I at ASH wanted dose in alluded go that the of a cycle.

of patients that patients receiving question. and lots in cycles first with had lymphoma FTXXX. have That your I yes, have with been of retreated We experience have other FTXXX was there now think multiple been

quickly manufacturing Your with we and XXX, two actually that runs release. XXX. second we released in recently additional will to upon question treat with shortly completed those a will believe we just FTXXX And be runs have manufacturing position respect patients be with to

treat will be weeks, with we the a I to yes, weeks call to patients months we’ll XXX. next in in it think – next or And position so,

Kelsey Goodwin

Okay, perfect, Scott. Thanks so much.

Scott Wolchko

Sure.

Operator

from SVB. our And from next we you. Thank Daina do question have Graybosch

Daina Graybosch

trials a for with response after starting your wonder away get or cohorts, patients the Meaning to you of cohort and on durability for the guess which test most second do to have given I many many that best it you a likely you opportunity is membrane that have ability the the on on in first FTXXX the ILXX the question Two on thanks won’t response? you said follow-up give impact one PR? is why CAR in a many, Cy/Flu them of reduce think One going you dependence complexity of transplant have then – could are Cy/Flu, question. And the on I wonder moving I doesn’t from cytokine? me. Hi, is it think ground

Scott Wolchko

Yes.

are first, along question – in your response. think are a I last last durability don’t we if study. So is – time on respect know just to we along I far perfect think example with enough test I far lymphoma with FTXXX to don’t of

We But over escalation durability great believe to seen. answer to and certainly to an study not really think of entire in I are targeting durability informative it XXX, to respect dose study the the clear a show with dual continue FTXXX judge be is FTXXX improvement remains I way is that will but question of antigen response. the given response. above to

is that candidate, seeing XXX, benchmark product but believe product think I I FTXXX we best-in-class of think FTXXX durability do respect But sort super that best-in-class with I first is the with excited with with administered candidate. assessed we to that and do being a are what rituximab not, a IL-X, response and XXX using with XXX FTXXX in is XXX? XXX can given is. keep plus Cy/Flu be starting respect is mind, With where absolutely. are but to why

degree may, though Cy/Flu we of reduce a some even likely so different XXX. we support cytokine for with instance, significantly will to move And of for conditioning, administer still form or

Daina Graybosch

Got it.

will that depletion deplete administer? the that what’s increases not guess the cytokines, all suck but the I think you all those just idea, that’s them your the it up IL-X on cells So, opinion don’t I removes you IL-X, that other

Scott Wolchko

Yes. No.

needs So, that’s done. why to be experiment the

things do I a transferred field in is the well adoptively think better one of think that it’s is while the I may cells. provides a fair question, for that as Cy/Flu because it for competition

fight think will need interesting there. fight, support And it own that because cytokine observation FTXXX, maybe so I with there be doesn’t its FTXXX, because it to has an Obviously, with competition building. that

Operator

question our Mizuho. Mara next Goldstein have from do from we And

Mara Goldstein

CAR Hey, on T emerge Pfizer a issue, targeting course, have XXX potential studies Thanks taking announced and reported a pause its – a on I of had BCMA question. multiple reported are neuropathy Great. for think X incidences, just believe, bi-specific Grade few in we Amgen’s have seen I FTXXX AMG and the this. myeloma, peripheral we as

therapies. was in setting multiple that understand likely am been treated as with you this respect were I to for your myeloma milestone have prior I neurotoxic XXX, curious R&D to the it can neuropathy would clinical payment thoughts And tied patients So, But anticipate with any work? what for work? ask just I if then peripheral to that that was achievement just or of also specific to on J&J any

Scott Wolchko

on that just this quarter to milestone last So, contributed is did the any trigger revenue. with not question J&J revenue. J&J We that

recognizing upfront. under the So, sort were allocation J&J The does the collaboration. typical of the contributors work from J&J revenue fully fund as as upfront all of the well of

So, FTXXX get for we but With comment the that history thing I gets right the daratumumab the Wayne revenue. work will on daratumumab respect experience has do [indiscernible], say as off the mean, is on Wayne and let with with let I will obviously FTXXX we I and paid combination one that. respect that. mean, I that myeloma, bat, in obviously a recognized with to well-established comment I’ll initial to

Wayne Chu

in different effector will we clinical CAR following some some question. with guess, think I that cell, one even have cell been It’s daratumumab cell with combined different what’s to T i.e., the that’s whether therapies a the more peripheral myeloma T. mean, bi-specifics T directed have the a hope is or safety based XXX a good been that the study observed may and more not to need we with than neuropathy these we a that’s And like address plus I experiment obviously of hypothesis profile an therapies, No. of one I really conduct. NK cell,

Mara Goldstein

case no But is prior in peripheral on Right. those neuropathy are patients based exclusion criteria there treated.

Okay. Alright, thank you.

Wayne Chu

Yes.

Operator

from from our Do question next Kim do have we BMO. And

Unidentified Analyst

Hi, the this our on questions guess taking for a progress. for and James part it’s Thanks on is I Do. two question. congrats

with engager NK cell cell you that lymphoma, iNK in preloaded is CAR using Thanks. FTXXX? merit NK a regimen And with there you doing how your in engager any cells? MD Anderson like an combined the iNK versus do think data Given using view Hodgkin’s cells combo something do

Scott Wolchko

will CDXX to combination of receptor leverage I strategy. been with our And that FDA strategy think our I today variety well-established continue to our in modalities. be has approved a think

I with I the able ADCC off-the-shelf believe and are therapy monoclonal fact also or is an malignancies belief and People in being we are of delivered a you both FTXXX combined I exciting that’s pursuing. can cell patient early has used have different or better think systems promote personally in strategy ADCC tumors, solid if is leverage what or what target. will, hematologic think think productized synergize that with is FTXXX with and NK engineering CDXX off-the-shelf, around to to in an more and that antibody opportunity that often it’s cell idea agents reach. and the they to or

belief. For a of construction combinations, cryopreservations much essentially manufacturing instance, and through strategy paradigm. patient an a a product products better manufacturing requires a antigen is patient that than personal us by That’s

Unidentified Analyst

was update Great, again thanks. Thanks next incredibly looking helpful. That week. forward and to the

Operator

And we Nick next do from our have question Fargo. Abbott from Wells

Nick Abbott

like on couple outpatient but I you then questions. lymphoconditioning of missed sort the you’ve forward. see of don’t questions, if Hi, good afternoon personally but to are mentioned times. know I Dan Scott, going a and call, missed this call, be regimen my you the I taking And thanks few of light a the for would will beginning

regimen, rates regimens? conditioning you regimen firstly has So, Grade reported what the compare standard related tox in been then have And can of Thanks. lymphoconditioning X/X follow-up. versus for and tox a I a

Scott Wolchko

fingertips. those I my or head don’t the have honestly off Yes. figures of top I

the lymphoconditioning to will think less be to toxicity it’s want conditioning have and experience for that do I I and not one better I a where better think say that needs and the would have recognize associated be cranking the up this therapies conditioning. with And I will those, therefore So and does lighter it. that just have therapies I the therapies would will that of toxicity go but to provide focused we opposed field very is generally think regimens things as the on patients recognize field on. we to And are

Nick Abbott

And thanks. then… Great,

Scott Wolchko

if of, you hospital to the maximize the risk don’t or are it’s in that’s if going no benefit. putting hematologic line instance, infection reach significantly happen. them malignancies you or for conditioning not solid – to whether patients, there you tumors, to is for way early instance, want go want it’s therapy, increasing the mean, I or and to patient think just I way

Nick Abbott

of listed trial XXX, or you a bit little you Great. And talk the and about inotuzumab can BXHX? then de-risking genesis so for a XXX trial and XXX of XXX with or the why is this

Scott Wolchko

– talking Sorry ovarian you referring to you are study? – the about the are

Nick Abbott

trial, the yes. Yes, Minnesota

Scott Wolchko

Yes, Okay. okay.

as aware a monotherapy. be you, monotherapy. from FTXXX trial wasn’t it was be are but FTXXX transition to I as public a starting yes, okay, fair, we with to to I with the suspect So, honest FTXXX will

combine begin with a BXHX with likely will We progress to locally engager.

However, in as developing product a is a candidate engineered you with we BXHX. fact know, are that

Nick Abbott

lot. a Thanks Okay.

Scott Wolchko

Sure.

Operator

And Burns H.C. have our do last from Robert from we Wainwright. question

Unidentified Analyst

cancer? expect Thanks. their daratumumab? in arms, we also is very the you This Rob. the focused of questions. lung on you you anti-PDXs if [indiscernible] please And are of can me still Hey, non-small-cell datasets patients just but on past, one are or provided excuse evaluating I FTXXX, avelumab in couple still combination have tumor you as everyone. One on the is FTXXX one last quick the just a have clinicaltrials.gov, have and on are like arm for who in guidance types further potential

Scott Wolchko

Yes.

be second sometime third update question in will probably the likely this your in year, a quarter. last half So, we tumor of the providing solid

tumor as CAR solid MICA as tumor as targeted. to, just avelumab are solid with for what broader is FTXXX providing at We and an we with our J&J discussed strategy tumors be product, respect will it will which under well BXHX FTXXX, that also first MICB. collaboration, the in we We seeing instance, time to solid update discuss with J&J in relates combination time the

we the this update fulsome in provide efforts. fairly will of tumor year, a second on half So solid our

your was question? first what Sorry,

Unidentified Analyst

have So, on the... clinicaltrials.gov you also

Scott Wolchko

now and on focused daratumumab. on Yes, is sorry. regimens with Yes, combination different with are that today are we are focused They the the regimen combining daratumumab. very we

Unidentified Analyst

you. Thank Okay, great.

Scott Wolchko

Sure.

Operator

this are I more that am time. And at showing there questions no

Scott Wolchko

Perfect. observations Thank forward next today. you everyone for initial providing update clinical and your look week. FTXXX time on with to full our a FTXXX We

Operator

today’s and you, concludes conference. ladies gentlemen. Thank This

may disconnect. now You

Fate Therapeutics (FATE) 6 May 212021 Q1 Earnings call transcript