EPZM - Earnings call transcript Q3 2017

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Operator

Good afternoon. And welcome to Epizyme's Third Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only-mode. There will be a question-and-answer session after the prepared remarks. Please be advised that this call is being recorded at Epizyme's request. to Investor call Relations. like Allaire to now THRUST with would turn over the Monique I

You begin. may

Monique Allaire

[Technical Difficulty] The We our third available quarter issued the website a press and on recent release at outlining epizyme.com. company Center updates. Investor press is results release of detailing Epizyme's

Joining the Business Chief Officer. Rob call Bazemore, and Executive Officer; Graf, me Peter and Ho, Suzan on Dr. Chief are Chief Medical Officer;

statements XX-Q risks related which in publicly update During of uncertainties. to the our undertake as Form our current representing to those this use of in and call, differ the represent plans, to we described section no as obligation expectations relied statements views this any of various including may future. are results upon Epizyme’s forward-looking views as We subject date to important and will November. Actual should filed and in due factors, any These Factor call Epizyme’s materially not Risk factors, statements. forward-looking including be

me to turn Rob. the Let call over now

Rob Bazemore

and afternoon month anniversary everyone, This for us. Epizyme's joining marked today nearly a you, good company. as Thank thank you Monique XXth

our have Over the our stage both and into significant of the as hematological a for organization. patients of and solid the value need. our we put which breadth discovery patients a important has transformational a medicines pioneered last bringing physicians, lines treatments have promise providing tazemetostat of potential epigenetic agent, very executed new culminating early we deliver closer late to to in the number of of strong in and and achieved and Throughout on candidate medicines, to With combination malignancies given program us in the tumors. late treatments and monotherapy product to position shareholders. we XXXX for milestone we vision on the a each important the epigenetic initiatives move development realizing decade, to were that year, built,

We tazemetostat, XXXX. a NDA of line submission for targeted have our for to treatment first the sarcoma for of side epithelioid

our to this has launch encouraging solid collaboration quarter, We’ve with We with engagement We program programs Oncology. XXXX. with our tumors the in our to of across efforts submission like NHL as and on pediatric our made of following regulatory patients our cohorts in NHL adult multiple expected track Enrollment around mutation are in accelerated U.S. and begin begun the tumors necessary tazemetostat the indications. advancements the our INIX-negative anticipated for NDA EZHX mesothelioma. support with establishing lymphoma activities potential in patients program later

development $XXX we next into through on vision. many our the follow-on way pipeline, third XXXX at made XXXX. the which identify after have progress We key targets supports we achieving are program million the strong financially to our recent our extended run and which of least With in quarter and financing, our a our operations way milestones are GXa, well

call. a have number on share to of today’s We updates

diffuse Let me follicular our discussing large and B-cell programs lymphoma begin by in lymphoma.

experience by encouraged has well very tazemetostat ICML update observed presentation, as favorable data which the activity the in with advance FL the June program our among NHL since safety, with we to clinical continued consistent well data Our as mutations, the patients and was EZHX are durability entire program. the particularly across

in and with an the FL enrolled pleased approximately XX% the study our EZHX prevalence with are with ongoing overall of center We DLBCL literature see patients align Phase that mutations. to mutations patients also II germinal EZHX having of

more NHL. study report happy update, as completing the are new important focus is site screening this our progress to patients our to we’ve Oncology enroll of they Since last U.S. already to number us for with two the recruitment an ahead, open which for Collaboration in helping markets to EZHX mutations with Since, path on more such look contributed one increase made cohorts we in are enrollment represent quickly. study. the patients collaboration As has in that may cohorts, EZHX enrolling of fastest tazemetostat our and fully our mutations.

are specific guidance enrollment providing to-date. encourage the screening the September a are put as have that we by we our screening we months with result August While on and numbers, being of that we’ve initiative seen highest place, increased in

presentation, We year. and both to NHL study company. We meeting for are present then ASH the number awareness before meaningful be full will a this and among momentum in ICML our have since seen enthusiasm an community continue. events plan we Phase from increase XXXX, in to also physician of an the there II expect update this our data anticipated important

to new registration for plan present tazemetostat path multiple fully data leaders panel we fast U.S. tazemetostat and engagements to NHL investigators our the with FDA will track XX our to with gene the have multiple hold discuss to program. interactions to tazemetostat designation, in define from and thought We NHL. Leveraging intent further

with the interaction fastest year. discussions to We where registration role tazemetostat’s to discussing interactions the represent generated later ourselves mechanisms believe interaction initial been key particularly aspects This overarching most review best compelling quarter. provide we from tazemetostat for the strategy To on use first from The we’ve anticipate novel for the data an next We to could in and program. this formally of the this trail for data. our current being FL position action, in of FDA early success the NHL. path to FL includes schedule update initiative has putting able plan market our into context to potential the

program XXXX, the filing with update and refine we’ll and strategy, and from FDA mature As as the our engaging throughout appropriate. continue NHL evolve we data this

program, our to monotherapy addition In advancing multiple in DLBCL. studies we’re combination

frontline evaluate investigate studies in activity as combination wild-type and to settings. and to and both designed are across studies combination the both a Our treatment safety replaced, Alcomer with of EZHX and refractory targeted chemotherapeutic anti-tumor settings. patients, agents, These agent, in are tazemetostat both a and range

for combination initial in various to is data with regiments, in goal XXXX. tazemetostat establish Our proof-of-concept

also anticipate lymphoma beginning combination next in We follicular a year. study

FL to the and We’re was our strategy. design study approach registration market evaluating both a overall our that support

So, we plan the with initiating. study’s design discuss to FDA the before

that continue bring patients and program tremendous FL believe potential the to today. holds by with We progress both in made highly DLBCL, where it are and to to tazemetostat the treating encouraged is

Let me ask tumor some our from update solid program. Peter, to review Peter?

Peter Ho

Thanks, Rob.

INIX-negative Let’s with our progress begin in the programs. and adult pediatric

INIX. this is for our and potential enrollment will in As NDA reminder, patient we our driven support epithelioid solid adult we completed multiple tazemetostat a of of July, believe loss the study cohort submission by XX that tumors In sarcoma cancer. registration in assessing

separate in our II XX additional pre post study a patient, paired opened recently up to to Phase and ES enroll tumor we cohort addition, biopsies. In undergo an who’ll treatment

data as translational other cohorts not In other cohort in exploring important will in share enrollment a monitoring in well pleased tumor studies, updated objective rhabdoid assessments their tumor for complete the by data futility surpassed these that tumors. study XXXX. with of have Although this Based we registration these responsiveness and data in that we’re cohorts representing intended effect other will of committee, this of INIX-negative tazemetostat to findings, as be assessment on immune purposes, ES, will generate on independent in observed both based treatment cohorts the our with plan populations. from the on our responses

the encouraging the warn carcinoma, involves forward cohorts assess a aggressive with continue activity, not these tazemetostat we’ve in more the the of forward cohort we’ve seen INIX-negative activity new including monotherapy rare potential enroll This patients, seen of sarcoma in seeing seen cohort recently a chordoma, enrolled confirmed to closely progress. and as in tissue with soft medullary with order chordoma, for tumors, early In to number new follow the evaluate that other in patients on renal tazemetostat this we’ve fully moving of activity cohort to bone look Based cohort will patients. how INIX-negative disease. up added sufficient objective responses, the around While XX a this to in we’ve we We’ll a patients to spine. to data these and sarcoma. patients

completed INIX-negative adult dose in with very the we’re progress study, we study. made study, through of and had pleased pediatric expansion. now dose portion In to addition we the the are In August, announced advancing that our our escalation

results chordoma sarcoma, at twice during in in XXX epithelioid us children. atypical our trial cancers. Targets tazemetostat’s Chi, or lead first our Meeting, adult investigator, with we devastating these with the doses and Dr. presentation dose study far, I oral an in ATRT presented consistent milligram and are Susan objective meter Molecular give escalation recently, patients Phase teratoid Thus above solid children at experience per These responses tumor daily. confidence with potential the rhabdoid data Just square pediatric observed from our in tumor

selected October Society CTOS sarcoma the originally data type. presented Targets sarcoma sarcoma adult tumor the presentation in for as a June pediatric at plenary the CTOS significant unmet the or in this meeting ASCO Additionally, of need Xth. been Molecular Oncology Meeting Tissue and year, epithelioid the epithelioid and have November selected at on in given have annual Connective

also We cancer selected tumor findings. we presentations meetings, for patients are the is very honored that promising expectancy difficult mesothelioma at the us share opportunity to solid oral out a have the is finish advanced treat both these To were program, data for giving Mesothelioma life study. and our to these poor.

follow study, as fully report evidenced investigators and has orphan will pleased completed exceeded order achieved and activity, designation was remain we having the to rapid first study by at a rate that In for on endpoint, announced weeks to months presentation XX% XXXX. which of drug we projected treatment XX we patients study many found for in in In are of mesothelioma. our patients the primary its planning and the assess our patients new data clinical both durability timelines. enrolled enrollment continue the the study. that have quarter our last September FDA We and tazemetostat We granted that control with for disease are options the ahead eager are patients to these XX

the And agencies highly how a the the treatment in seeing potential new by we forward disease. look this to progresses. of encouraged are We to tazemetostat become for study recognition aggressive

the back Let call over me now Rob. to pass

Rob Bazemore

Thanks, Peter.

As our led proprietary our next to we has to drug XXXX, bring corporate introduce forward progress in to have been significant the talked has programs clinic epigenetic we’ve in by platform one made development. discovery and and candidate about goals of The pipeline. breakthroughs development new into the three

and dangerous rather field treatments crisis Current disease cell disorder. discovery target, against of of HMT modifying the program is cell inhibitors, focused effects a oncology. efficacy sickle than known original quality our HMTs Sickle the We and and the blood serious during cancers to These link published disorders for shown a the the as group scientific of blood research caused diseases. our symptoms. our and a disease increasing and led has disease, oral with various at treating an will presentation is histone that target of modify platform blood follow associated literature, to we a to shape most disorders methyltransferases the on the HMT which abnormalities important cell in share sickle this complications, treatment This cell other initiated and In have know that inherited hemoglobin diseases. stroke. a that abnormalities third-party the new feel has has of research the flow, disease the cells between in program the The on blockages next the underlying to program novel including episodic us application on excited red the efforts science urgent the hemoglobin. treatments GXa of GXa toxicities Based utilizing of in into pain, GXa and shown that a is the of been disease clinic, high and anemia need will or level tazemetostat ASH. for am fetal like or have reactivation demonstrating and vaso-occlusive for an chronic data for sickle of body. present limited GXa. other extreme development While just an challenging the I cause range inhibition commonly in inherited includes find clear blood disease,

GXa which Our a preclinical ASH. We when confirm hemoglobin, direct look that inhibition the fetal of between with GXa forward relevant our a link inhibition to to approach. totality sharing of believe more the clinical results and lead details combined us data is potentially at reactivation of

our pipeline, in across position. In addition to progress the made business a is our strong very

to Susan provide Susan? ask me our review financial brief a Let of strength.

Susan Graf

issued details press Thanks, of be Rob. our The in can results found release the this morning. we

few points. a highlight just me let So

year productive for been As XXXX have a Epizyme. you has heard very

we As important in ahead value create and many regulatory strength achieve will advance our future the for look company. and our we clinical have to continue that milestones to financial the the pipeline

do raised have follow-on research our in This priorities. capital focused $XX.X we with discipline third modestly completed Toxicology clinic. spend Particularly quarter capital includes We reflected NDA quarter strong third and to and offering, $XXX.X strategic net continued we this along not from is runway September. cash. the in financial trials, expect and preclinical XXXX. least our grow heading of $XXX.X potential of in the our cash any as with position million Importantly a XXXX. to third This in of at $X.X runway development in of and GLP account of to towards the The associated the other executing our our additional million oversubscribed operating initiate ended effect G&A to first non-dilutive extends very expense on security. operate prepare take against does the marketable sources cash additional work a GXa initiate for million financing million into and into by milestones our R&D expense or We XXXX. covenant move program this Notably, existing our cash, for submission quarter into equivalent proceeds with

Epizyme's about for it particularly future, funding we of shareholders. strong maintaining and As balance creating relates the sheet to think a our value as

the to We to launch. disciplined focused successful our investments, approach scaling a are taking up the on critical insure to items company

in this the tazemetostat which candidates the and our XXXX part of of approach the just to close pipeline into delivering I'll Rob, a support Rob described. widely We to call back first advancement by plan the take efforts to to investment invest continue structured to three will of now earlier new our out. as have long-term clinic

Rob Bazemore

of commercial set XXXX our prepare significant and our to potential made been given early transition Thanks, the the mind transformation year is Ho launched in and of stage for has that his the of been Epizyme Susan. stage leave be first end passion company’s R&D. has product. a It's to the our with Peter towards has that for XXXX tremendous a year Epizyme progress a begin at year always we as company decision

identify of organization XXXX, Peter instrumental will continue and tazemetostat Peter the strategy our Since year the as to his Epizyme and our successor. building Importantly, where lead throughout the clinical bringing joining been remainder in support regulatory clinical program the in it we efforts strong has to is today.

be for We transition not the team serve through all and like our provides is Peter’s R&D phase he done we organization, entire underway Expanding Peter search evaluation. launch. preparing in efforts, would for I of all development is are incredibly of our thank strategy and we of NDA Interim grateful for Medical ability securing clinical the process without of through which submission capacity transition. has our our are exceptionally already that continue who approval. The record first on organization’s On development for to seasoned commercial remain help the the us objective. can to with the consulting the for next many The completely approaching clinical in the planned and tazemetostat trails confident year. to executing for We're an its highly next this for of I late-stage the a executing tazemetostat. would to This guide a as all Officer Epizyme. leader the Chief company ability in experience new to strong ongoing candidate treatments add in executive extensive senior attract opportunity to to drug team strength confident with development a and a track driving clinical our new behalf of

market. leadership tumors, to and clinic treated We maintaining change have efforts. new advancing lives. way regulatory the believe patents’ Thank team with these have tazemetostat a track we improve including positioned of joining open to bringing in We to new We a commercial call the strong many questions. three the to for deep through an to stand are capital severe our achieve us development opportunity We’d you record and solid place to into support now NHL and candidates like today. and a vision launching potential diseases well epigenetic executive and XXXX, in the for expertise treatments the

Operator

first is [Operator you. question Instructions] Geoff with from And our Porges Thank line the of Leerink.

Your line is open.

Geoff Porges

for are you've things very Congratulations much going and taking us all Thanks I the Peter. for thanks question over the well. help years hope the given

on questions quite program, few a of an terms In important lymphoma driver.

what could there then XXXX filing? regulatory you've timeline there have follow-up be committed of in you And on in a perhaps is a to given the expecting a worth potential opportunity have strategy clarify question patients expect So there. you subset And what data, and filing to to XX or you'll lymphoma what particular you're for XXXX? that combination mesothelioma, Thanks.

Rob Bazemore

Geoff. Thank question, that I'll around regulatory in to the data meeting next the later combination quarter. answer ask approach that the And the plan we fourth the question including address have with I'll first year. Peter you for we scheduled to your FDA have the

Peter Ho

we of results Yes, to that forward. have you we work in your in that my we something which hear Thank to words that wonderful think benefit patients really been The ones move combination DLBCL in is on trials sure. ongoing will in from pleasure of for has kind expect are drug lot a as to it bring XXXX. the terms tazemetostat, I a Geoff;

therapy. the the regimen this as elderly plus the DLBCL the that tazemetostat R-CHOP risk in first started used is And one we've So patients being high frontline to of where R-CHOP review is is just combination study.

into and in with study the of full trial in Xb/X to the where dose very Phase been so being formal progressing that And definitely we dose portion. being the data of dose it tazemetostat from we phase this before a share through combination portion is and are II are have well able R-CHOP. on study first to escalated is that anticipate this moves Now phase escalation parts two the

have results prednisolone II our Phase tazemetostat been year. as we patients, has progressing should share the an have and that very monotherapy nicely DLBCL that for the well to steroid Beyond next with combination where is of cohort added we also study, to accrual

collaborators is ongoing that at being The with that combination because atezolizumab. that is And in our operationalized is DLBCL And study study is Genentech. third by the commitments data make a more accrual again, is operationalizing very the But is of presentation. little know study firm a in study well. the that Genentech that difficult a going terms to to that along we that is

are And those for studies the three looking we're data. that existing in DLBCL so

Geoff Porges

Perfect, helpful. mesothelioma? then that's And very

Peter Ho

so absolutely in in Okay, on study. that parts setting. monotherapy treated mentioned yes quickly as excited mesothelioma, quickly -- tazemetostat line two is second the how very patient patients XX it very accrued. been you has monotherapy in by sets of being And we've The study the

we matures look to as know as we the summer be we've do accrual XXXX and the those well. data following completed in as So in data you time. it representing are And

this didn't of study started from an any have Phase we exploratory study, the as case tumors. we many for Now X mesothelioma other our clinical the unlike experience

of move enthusiasm a But at we agent as with well. the that we best as of what to in so this of patients terms be single to a mesothelioma. patients having potentially saw we'll as give certainly us share therapeutic type from targeted to trial, our And direction investigators monotherapy, looking for study or forward type what whether how

Geoff Porges

much. very thanks Great,

Rob Bazemore

begin define the now large quarter, the on We of path begin are guidance that our follicular data for know by schedule represents full, And evaluating lymphoma is and it fourth program interaction define diffuse the since to and exclusively that non-Hodgkin B-cell But has is ongoing, call excited strategy, since of still are this the lymphoma. evolution we And a with all patients follicular on potentially is the in lymphoma we’re encouraged mutant continue focus interaction path lymphoma. update the seen we’ll to been the we first we’re fastest in most and scheduled. in both the first we’re EZHX the patients to so believe We with This important tazemetostat enroll as that regulatory large study you market to of including first where that follicular terms still the and path, this lymphoma in is we’ve then that this interaction would was far. presented responses to Geoff, excited registration to cohorts thought we to lymphoma. the in so NHL cohorts.

first focus interaction follicular this will exclusively So lymphoma. on

Geoff Porges

thanks. Great,

the follow-up, EZHX a just we data you clarify particularly as enrollment? for see the to to expanded population will when could you add get Just the

Rob Bazemore

a be mutant -- able Jeff, obviously present sure meeting. to it’s would also able be we of We’ve continue want the be would But at to And the cohorts. follow for to in data this XXXX. priority to to is defined our the meeting which understand benefits. to it EZHX enroll Yes, to to able data intent better present able medical not those we that be to be be medical important durability that

recall, data a these we the have both we’d you presented very of when those were As many data still therapy. in patients full to when of two summer, update. present early things, like this And we

will that XXXX. be in So,

Geoff Porges

much. very thanks Okay,

Operator

next our And of the with from Augustine Carmen line is you. Thank question Jefferies.

Your line is open.

Carmen Augustine

the thanks there, taking question. Hi for

might FDA DLBCL? the to present detail we comment able lymphoma, back follow-up only wanted to expect update go strategy you the update So, confirm expect to so, early first And follicular and could update see will on then? FL? you of regulatory when to be as forum in, a just that talk level the be you what to XXXX the on about kind what if Second, on, Thanks. to of

Rob Bazemore

Carmen. Thanks for the question

first on the the since follicular provide interaction be that to XXXX be interactions plan we So, will having. we’re on that of that the regulatory the focus in think first lymphoma, early yes, I update will

who easy who large diffuse cohort, mutation, terms EZHX know, FDA continuing the response. EZHX mutations, is. benefit sense follicular evolve enroll. DLBCL, with clear and what or of number We the in In engage the overall to saw like will DLBCL that real the compelling in patients estimate we have the population, have of mutations. EZHX as to feel where the patients XX% lymphoma We’d like timing better a of have B-cell patient rate you a with with on Unlike the response continue this very we we’re to lymphoma, when is of in reengaging

goal bring strategy Our can. to of sure ourselves likelihood and we of tazemetostat as with to the market for being quickly the make that to able here DLBCL we is success ensure highest patients with both FL as

Operator

your Carmen? that answer Does question,

Carmen Augustine

does. it Yes, Thanks.

Operator

Thank of the you. Eckler our And is RBC with next from question line Markets. Matthew Capital

line is Your open.

Matthew Eckler

Great, guys the thanks question. for taking

any So, theme file? here, sticking are able are you data update separately, meet of to meeting of guess around all with provide And time your lymphoma you the FDA? particularly needed the I then for around follicular many patients you may at worth assumptions by patients number with FDA how have to the what

Rob Bazemore

interactions. them how really yet. generally you Matt, they meeting provide the require We the may want initial for on as FDA to I ongoing registration, with question. bar, what regulatory that would the not we’ve had the thank specific for many Yeah, patients considering wouldn’t don’t on details set speculate

Matthew Eckler

to more a Okay, cash flush run this does guidance, maybe got you assumptions an then into that? need out turning what your specifically additional study? NHL And it. Understood. just current the go little bit if include And any assumptions to could around maybe

Susan Graf

Matt, Hi Susan. it’s

in it combo a combination Genentech, includes assumptions which runway with And study, terms initiation patients start we’ll lungs initiate It into XQ by It for [technical other will non-small on year. the have of enrolling of our going which lymphoma key in which includes study clinical difficulty]. In studies cancer, some we of It we’ve into approval sarcoma that. the cell that also follicular new our have already the that in that activities, with at include NDA. of includes collaboration accelerated guided ‘XX, least atezolizumab assumption an does of this new also end on path terms XXXX. a epithelioid we’ll with confirmatory go for current

Operator

please gentlemen and Ladies standby.

Susan Graf

us? understand Carmen us, folks I us. hear can on hear you line hear can the can you that

Operator

may you And presenters continue.

Susan Graf

Brilliant, thank you Carmen, back. welcome

please? in So who is queue

Operator

question. may restart with Eckler, you your Matthew

Susan Graf

Thank you. not Did you are hear sure. the we answer,

Matthew Eckler

I of part. saw heard first little the I -- very

Susan Graf

were guided collaboration we’re also study, lung Genentech as Those of start will cell we’ll this enrolling in which guidance. way conducting study, study did start the of confirmatory the communicated as patients XXXX, sarcoma would the studies It that which the well we included for in have our cancer assumption an accelerated updated non-small the ‘XX to included combo the combo a new with Okay, new studies in atezolizumab guidance initiate plus that with we and When program to financing follicular again. expected only path the year. and be the on we by least recent be that epithelioid at new have XQ in indication. end tazemetostat included the we run approval also a lymphoma

Matthew Eckler

Okay, got you. it. thank Understood,

Operator

our question the And from with King you. JMP is next Thank Mike Securities. of line

Your line is open.

Mike King

better well, we presented. you and we your Good about could Peter wondering of But weekend. the that got speak to might enough Peter window you about guys kind that taking as sarcoma, was afternoon other in PKPD of you you like got feel for brain therapeutic groups of And doing, are need through you brain get MTD are penetration. won’t many searching dose think you to an do this Maybe great epithelioid talked know the results for? I see how you to more for question thanks based the guys, I to on that go work past Peter MT, have looking some you’re talk am get you penetrants Philadelphia that some you you just the if before it you while

Peter Ho

also Targets Thanks to see Meeting. the you great very and at much Mike Molecular

rhabdoid pediatric sarcoma So -- X tumors. are it negative of epithelioid which related Phase tumors of tumors of tumors negative that for higher that is to a a INIX primary it’s to the question proportion not a limited unlike much children brain in ATRT. territory INIX And typical trial, solely case the our group course the adults is

we And as that so exposure systemic targeting a you that greater penetrants. for get it higher mentioned reason to is CNS are

Now several we're expansion dose levels gone we the phase. and have through dose now in

that not in escalate in per selected will further, To square the certainly we That evaluate we milligram higher -- having have we And does we of but group are that know do to that much we escalation that phase don't from X indeed a in hope X learn we that in on blood well much whether larger So provide the than systemic a children case, expansion than barrier. brain in behind children X,XXX where penetrants. hope effect greater having -- as to we adults. tumors will exposure dose. and fair that to be be CNS we is anticipate meter going cohorts pediatric the patients to dose result this really recommendation are than had exposure cohort our the

Mike King

from for for indication? Okay, pediatric regulatory on to color disorder taze do I what to think avenue a this additional rare thanks for a that. just strategy you in application filing realistic And consider also down? the ask might wanted And you At that's standpoint. point go

Peter Ho

been possibility with great into looking we point a as that colleagues for And have our Mike. here, us. regulatory That's

that that are exploring still we’re looking hard about. tuned, that we something and certainly at stay So, thinking is

Mike King

the indicative response to the more I some what regarding might that formal And your ASH shift can markers that I are gene or abstracts you in I you had be comment Okay. of could or the and don’t interesting just Rob out of provocative today if panels outcome. gene about signatures know mentioned remarks.

Rob Bazemore

Right Mike.

this a we present to will dataset updated patients showed that we summer ASH. more we there panel intent When panel update XX XX that ICML more all presentation the complete be to that before an at had have of included. showed gene is first summer patients the the be actual at analysis. had with we outcome intent on patients But think this data about this analysis. the we in done is further to I involved able And

data in a we'll analysis final that tuned, presentation stay So the December. on do before

Mike King

And fair program. you the mentioned then GXa pipeline, Okay, enough. on finally your just

also approaches just of doing, late cell gene something that blood a tremendous will just commitment has whether at radar. a ask a you. CARMX thought a of And I'm in point a et to commitment and is at of positive has that standpoint corporate I resources wanted corporate anticipate moving from things program view you from one So Thank you just of between target had wondering attracted a cetera. And global wondering if what potential forward? of mentioned kind that that of like the your is point therapy IRR? generate resources past, still has that amount is sickle

Rob Bazemore

why and to inhibitor to can that maybe this resources committing then answer were we is molecule to program the this disease they at our an ask opportunity So GXa a comment standpoint like on feel the I'll this important and the Peter of for comment from point. Suzan

Peter Ho

Sure, thanks Rob.

one hard terms it of in mining this in we HMT to came GXa from worked know from as all you on the at applying take the to the and having group how been we've the and for extensive for we Mike about discovery other is but of very this the as GXa not in platform one only space. sickle that's HMT looking targets, So efficiencies HMT cell. cancer ability years And case the learnings targets. having do discovery of And to

monogenic fetal very is leveraging be reactivation sickle GXa of been obviously So by thing we're quite published the to cell right really to that science that different being a therapy even are would approaches an very, for underserved. is a the which which expression, apply a and really able small that I being sickle linked for now. that And epigenetic very we're for is hemoglobin time has gene taken long with great mean known others, approach really disease. approach traditional where than recently patients striking a disease, the to molecules which we've cell was now

Susan Graf

plan. the around our And part in we Mike investing new as our resource we XXXX long-term that three as know development commitment of you via this, vision into deliver have our to terms are of candidates

disciplined costly, to impact to evaluate become are the progress does investment as those we what a of the we program course taking and continue approach candidates this program. will more are and We the of

Mike King

GXa just you an would Peter I the program program? Alright, assume those oral for be details. thank additional

Peter Ho

oral haven’t pharmacodynamic to speaking of effect to we pinometostat candidate to be tazemetostat and dosing inhibitor will the a but have best is is be declared had details oral precise to the an more and Mike agents spoken certainly deliver respectively was it the having to think in an we we of that ASH, and molecule at IV both that our that’s that way certainly and certainly we Well, HMT and the philosophy.

Mike King

my for Thanks guys. great. question Okay, again taking

Operator

question the next Thank SunTrust from is of Lawson you. Peter line Robinson. our And with

Your line is open.

Unidentified Analyst

wondering is from other X Lawson. adult futility moving of in hurdles Max Peter it can for the the the same the in cleared patients? this first just is Phase where stage the XX study, was Hi X the futility out if the tumor you INIX-negative response in hurdle as clarify I the

Peter Ho

So, aggressive INIX-negative at hurdle say, it to with diseases not but we be really can mean, respect adults details all are here, by into gone for cohorts the existing range in very very, to well diseases. futility of the served haven’t and I these each suffice to therapies

set accordingly to cohorts those So, second to the we stage. and in we’re to that seeing enrolling obviously that we want full for not the to that other complete cleared activity study. first the stage two, again to read insufficient and wouldn’t But enrollment be just it sure make that bar rhabdoid out tumor looking the now the and will we’ve the INIX-negative such

Unidentified Analyst

any in half? have might when on it’s can to guidance color or which do going XXXX, half see any I you updated about give we conference be us medical or that second but And know first you

Peter Ho

working meeting for time. put the complete it’s now appropriate the us think but little meeting enrollment, at are since and I we early to it certainly we will a out Yes,

Unidentified Analyst

Thank you.

Operator

next And Robyn with question is line Citigroup. from you. of Thank Karnauskas our

line open. Your is

Unidentified Analyst

on for Robyn. this is [ph] taking Harrison Greg Hi Thank for question. my you

more could Thanks. what Just or should the commercial further we restructuring be wondering changes expect guys as are this there expect big is can just company, a transition kind a you to we of any of picture continue change? become what question around that

Rob Bazemore

good planned so expect the as changes wouldn’t have we the executive evolve And I So, needs, stages companies of other on transitions their based think level, leadership year have I and for our for expanded for leaders been opportunity step-up this they been to roles provided have on significant had company. different any an that and the do and teams. company what through the those and good individuals they take have

on those. clinic we performing the delivery the GXa that ASH. lot side then program first you If the to be into how at look program was of intent at talk more a the molecules to we’ll bring is are able And of the three new research our about

process September. commercialization. bring tremendous And it Moving as who done job products to using as financing financing amount explained Peter executive And late tremendous company think the as then record going seasoned has a partnering organization and approval sense well to through this under Susan back of in tremendous terms forward the financing Susan stage opportunity gives amount markets. of in brining has track us a transition as that in as of most recent capital well we we a the made about of a experience, an a clinical how including executed both just clinical

anticipate like we asset organization, in next to the that that organization, I commercialization of going we tazemetostat changes an manufacturing the part medical Those year. say the functions So, marketing be depth are the would for kinds to scale year we of as of next supply. up certain that affair anticipate are would adding that the changes commercial

Unidentified Analyst

you. thank Great,

Operator

is with Thank Porges you. line Leerink. question the next our Geoff from And of

open. Your line is

Geoff Porges

you taking seeing is the the mix on the far -- of I are chordoma based can path see tell? And to obviously want Thanks what a little follow-up study? patient question. you out Thanks. as about then the we might what talk little for as bit bit incidence just the more development be signal that

Peter Ho

this Geoff Peter. is Yes,

there range chordomas all which of not on termed clarify, differentiated majority are INIX-negative are broader are a to the be differentiated chordomas, that of they chordoma and deep we're to this the poorly to patients. focused just group tend and once that So is of chordomas or

in the study and very we've So, well up now. study pediatric activity following seen adult as we're some in the that interesting

as So a rare really as a course epithelioid similar sarcoma. it of we look path sarcoma, is which at

data population things, want a of commonality eventual may days existing with in there shares terms I early again to in one group so molecular getting certainly the of It’s be therapies in clinical focused to in terms but sarcoma generally laws. and additional epithelioid by similar can path sensitivity a don't patients their do very that EZHX of overstate and that registration an see And to identified well like of defect this acquisition. INIX this are who

Geoff Porges

Thanks, Peter. Okay.

Operator

Q&A Ladies final Bazemore back Rob and section our for concludes remark. the for to would Thank call I like you. this to his today. gentlemen turn

Rob Bazemore

the year important the days we’ve Thank joining a XXXX today, a you. in talking NDA. XXXX look readout, again been we has and data significant delivered us milestones. Epizyme on of again Thank be for forward transformational begging you where for first will numerous our pivotal the more for and submission to of trails year number with year and ahead. new weeks

Operator

disconnect. call, in And day. This for may conference. the ladies wonderful concludes a and participating all Have today’s and gentlemen, thank you you

Epizyme (EPZM) 1 Nov 172017 Q3 Earnings call transcript