SNDX - Earnings call transcript Q1 2019 | Syndax Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon ladies and gentlemen and welcome to Syndax’s First Quarter 2019 Financial Results Conference Call. [Operator Instructions] I would now like to turn the call over to your host, Ms. Melissa Forst with Argot Partners. Please go ahead.

Melissa Forst

Thank you, Operator. to Quarter you Call. XXXX you for us thank First Syndax's Financial and those joining of today Welcome, Results Conference

by us us Michael be; prepared Morrison, for Shea, you call session Chief Operating a and this will Officer; be And Rick call Joining Briggs also Peter Chief for is Officer. Dr. been being This on forward-looking so accompanied Dr. question-and-answer turn deck Meyers, joining company's Officer Chief Medical X. the remarks and posted slide Chief today��s President Scientific Dr. Ordentlich, Metzger, will Officer; on has Michael Financial and to on that website, Chief Officer. Slide to Executive statements the afternoon I'd please ask the

to am turn well indicated of available quarterly company's to Chief company's forward-looking materially as begin, of most be you Private www.syndax.com Act those during And historical XX-Q website, I Syndex. Officer Morrison, XXXX. I A Reform statements be made those are SEC. that, of following Dr. of like meaning today, call only. replay as the section reports to will on call. Form factors, report the various are call call pleased result Executive over considered Briggs this with the we May the discussed Litigation statements the recent of to statements the of filed may any the with on views other the would in including as this Any Risk represent Actual within X, XXXX, that differ as that company's of not Securities Factors a from by the statements remind forward-looking results these Before

Briggs Morrison

summary call much very you our everyone on Melissa a webcast. corporate us X provides joining today's on you the Slide and high of to and current level Thank for priorities. thank

opportunities. resources focus through exciting two we continue on progress incredibly year, this to you our As

Syndax, are and survival anticipating of the the the we cancer EXXXX, Safety again transformative scheduled hormone negative consistent Data overall receptor entinostat believe but assumption. receptor I is our in cancer; be This would Phase our first X be second readout in trial our trial launch blockbuster would subsequent corresponding of breast carries product. informed for positive analysis first and base a We encouraging for first has our of completed recently continue landmark cancer its patients. Committee a our opportunity positive will that is The breast emphasize positive as want to entinostat hormone with their case that and result importantly in filing quarter receptor-positive us shareholders HERX The a positive of trial hormone planned. potential. most NDA EXXXX and Monitoring interim breast and result

our turn at this upcoming Young moment now Roisin XXXX to the Dr. here like for ECOG-ACRIN will attention everyone to Connolly past take a Investigator fourth to behalf of We quarter on the Friday. also Award analysis. winning Syndax I'd congratulate

appreciate we successful know, Roisin lead EXXXX that the As investigator and the EXXXX done all a make to you may is work for she's endeavor.

leukemia clinical Second, program track targeted initiation this treatment acute menin agent SNDX-XXXX, for on best-in-class an rapid for our mixed first of potential broad our file we of IND remained quarter and lineage the by to in followed leukemia. the

we with important represents will the believe of another investigate that molecule about potential see more acute value becoming opportunity. company. XXXX we learn to continue leukemia, the indications this XXXX for We our driver second of blockbuster a in breadth we As

plus either entinostat Phase on in exemestane randomized trial the cancer. clearly a patients exemestane positive X design overall the survival. XXX The of now entinostat, Now of focus has let is detail. me Slide in trial of breast versus this HERX summarizes trial and review these more receptor to little hormone our negative plus opportunities placebo X,

quarter every achieving trial continue positive conclude conducted study before, is events of interim are I analyses final months trial as second six needed regulatory the would interim receptor for analysis and allow in in each Safety analysis survival approval planned. cancer us and based a protocol upon the futility or is futility file informed improvement each we've outcome passed the the that a upon that formal significant overall Data everyone evaluates to number upon positive recently the therapy overall Monitoring statistically survival. at the the trial as a the based analysis that with As at FDA. breakthrough formal analysis to our noted went the approximately we process Committee special The OS assessment us like interim any possibility on possibility and terms breast the the analysis remind interim metastatic designation futile that through hormone interim, a through both as well based to of

November positive when survival but possibly event therapy be responding are in stopped trial believe therapies, of of of being are final increasingly a has CDKX/X will this occur, we need in events. positive. potential stopped after futility will the a for most So will not know X conducted analysis breast who cancer there's we be blockbuster agent will patient the pleased done, a that the a based and confident final could therapy opportunity. the inhibitor. modeling the CDKX/X market has know receptor are we've trial XXX agents, to We analysis remain XXXth be hormone Ibrance, notably as Slide representing used trial we that for effective this CDKX/X entinostat-exemestane occur XXXX. for May first-line regimen unmet to The be HERX year preferred clear negative that We upon the for don't emphasizes there the once in or the that

could highly that's the post-CDKX/X inhibitor a the go to with substantial therapy hormone after excited relevant entinostat other XX,XXX rearrangements. our patients Slide quite and and first-line regimen. result that XXXX. is the on received shows and between to that receive EXXXX proteins receive course of current This similarity estimate therefore between Our entering a medicines filing failing is genetically-targeted who We're be CDKX/X in population. the agent the XX% upcoming eligible prior that trial, menin of for in have and X of patients dataset each have will therapy estimated also about IND patient fusion year patients are a to have of XX% attacked population program chromosomal our who an will we

of specifically fusion IND fusion is to translocation, I evidence a from in such recurring there to of then, path. XXXX populations gleevec process. that oncology the medicines leukemic filed that known in resulting targeted that medicines translocations, that of patient the the a a and the rearrangement been program and status treatment of the specific these designed on chromosome, program the so-called chromosomal EMLX-ALK the fusion were Being leads soon the X/X led led an to therapy chromosomal large based and On is attack that of chromosomal this Once Slide drive a to example a a define cancer be fusions, be protein, other is which against rearrangement NTRK regulatory BCR-ABL have thereafter. to begin enabled of demonstrate effects patients program. including provide X, specific these that there Phase specific example was precisely result program. BCR-ABL of first emphasize our proteins Phase cell. able strong final development and of inhibitors. driving want developments medicines was our Philadelphia In with is and fusions development clinical chromosomal clinical fusions. examples fusion clinical protein which we details to protein The RET to in rapid The results the this many that track able we'll understanding summarize our upon to the IND the quarter, to later X/X approved, Since

with I is disease based with that to IDHX However, clinical Leukemias. mutations. leukemia that by Again, NPMX our path the that showed Leukemias And to rapid goal children was we with adults ASH followed straightforward to enroll preclinical development say the upon data compelling in which fusions at a promising December, emphasize this and enroll intend mut well. adults presented MMLr can very also we we or path past similar see has XXXX that NTRK that activity for XXXX to want with taken as patients for MMLr

observe value for We expect agent unlocking the Syndax. should molecule that quite path, activity and single could clinical we in early clinical it's again near-term the significant that development possible activity have

value leukemia, continue driver. in As we learn we XXXX of about and an see the potential additional more important acute this molecule becoming to

evaluated program we multiple me our a this program, our ENCORE set entinostat but patients, of investors strong Let with who's PD-X program will I important briefly of with progressed entinostat other pathway conclusion combination the benefit trial combined to exploring prior AACR, types this after We've presented which to antagonists. PD-X decease ENCORE entinostat remind recently a settings. X as clinical up in is in summarizes clinical a also We biomarker, signal-seeking with with that blood was different is in We've turn not identified benefit environment data chemotherapy in look tumor patients cancer an KEYTRUDA predict indicate peripheral today strongly antagonists. work. immunologic X clinical signal believe at immunologic findings monocytes patients. the in the effect could quite also biomarkers in for entinostat predict we immunologic ENCORE of in class benefit. is results our that that tumors. clinical see shows both in inflamed and is non-small that a has when different that appears Slide The the characteristics. consisting variable with O beneficial Slide tumors evident lung population now

this seen we've whose a has feedback patients a positive patients deliver both clinical who potential combined alternative received meaningful clinically durable after currently like the in to strong to and PD-X and therapeutic the with KEYTRUDA recognize inhibitor when inhibitor. is investigators, benefit We're area combination melanoma, encouraged a on lack addition, especially options. are of In by from progressed with CTLA-X we've us entinostat benefit who and disease experts

trials. our the advance the will we entinostat-PD-X positive programs to one registration OS we determine more or on discussed following last As whether quarterly results, availability EXXXX call, into combination of

best-in-class stem the reducing and potential Chronic manifestations We XX that development last receptor. of opportunity Let host believe an our the hematopoietic in monoclonal host anti-CSF-XR disease Slide frequent and a donor a versus year. preventing the look cells SNDX-XXXX, this antibody me in now depletion disease result CSF-X contribute data graft pathway to year. initiated to and chronic the CSF-X In in the preclinical donor of of forward we second of disease to many of versus attractive chronic targeting complication fibrosis represents blockage versus graft graft trial initiation turn versus of in models, fourth disease. host is testing turn symptom. in can the advanced and of efficacy cell transplantation, We the wherein macrophages, of quarter with immune host disease antibodies chronic half the initial graft sharing thereby derived

summarizes acquire many Finally both how that ability the SNDX-XXXX we and expand Slide strategically we to the completed that have pipeline. prove to XX transactions have programs our an Menin-MMLr

Our a and extensive identify agreements. closing gives established to and experience us have team in quality, differentiated of allow development our advantage relationships assets, clinical management that us team board competitive the

I'd this strength call We in and discuss this Operating efforts continue to consider President Metzger, to of area, Michael? now our like we core a turn to the Michael over to recent our Chief financing. capability to and Officer significant company. be our expend

Michael Metzger

Briggs. Thank you,

million financing completed XX This financing $XX.X accomplishes three new and As for important we for equity summarized raising the an sets capital. on important in success XX Syndax. to March over on goals XX, us Slide next up months XX,

our remarks, in extends receptor and his proof metastatic program the First, operate us to hormone runway, program. of enabling milestones cash Rick beyond in detail for breast concept XXXX entinostat positive well as will critical the and financing cancer

raise price set limit up creative financing And premium of stock market our a the opportunity appreciates. at shareholders. existing through amount time offering shareholders quartile the opportunity the us at premium capital of to list this warrant the when This investors as our undervalued. structured serve we our as add additional to the the gave top we structure and dilution significant stock to is a structure significant Second, significant believe third, to to our to

results. we Rick? Rick for over build how to the new are financial are We our thoughtful are we to about and now quite with shareholder who aligned review to have building value. base shareholders, call I our our long-term will delighted turn vision

Rick Shea

Thank included Results so our these in our XXXX press to Michael. them are I won't remarks. you, the of year in operations the and repeat release, comparison prior QX for period

financial XX-Q, file in Form available week. to Additional this report we on details our later intend be will which quarterly

Turning was offset a $X.X million. of the XX.X The cash million to Slide by $XX.X was in from $XX.X shares XX, from burn change in and XXXX we net ended for QX $XX.X The the net outstanding. first with proceeds than our proceeds increase cash quarter net operating offering, of of more and $XX.X of million of cash ATM. million million million

I'd ahead, the for full guidance XXXX. financial of QX to for like Looking provide updated year and both

non-cash and stock million second expect R&D quarter $XX to of the For to $X.X million, $X expense. approximately to operating expenses we be $XX including million million compensation $XX XXXX, be of to total million expenses

unchanged. year XXXX, full is our For guidance

of million expenses are to expenses include R&D million. of expenses million. $X expense income to offset for to is $XX expected million expect compensation $XX and burn XXXX $XX cash $XX to by for total million non-cash so million to interest our of expected $XX of $X and be approximately million XXXX operating net $XX Operating stock We million,

prioritized So spending targeted EXXXX the operate this inhibitor. our early our for to will us our programs, with menin of company to proof milestones key for cash, allow concept along results achieve and specifically reduced OS current for

the Now, I'd turn back like to to Briggs. call over

Briggs Morrison

Syndax Rick. a significant be with summary and like our result our Thanks for shareholder clear a EXXXX company I'd OS create close very much, value. would to We call believe transformative in priorities. that positive of

year, later prospects our Although the MLLr the this potential menin could readout are end for for mid-XXXX. occur inhibitor. a final for in by of OS we also We're readout EXXXX prepared XXXX, excited the final about very

in and that the we for quite remain expect AACR. activity believe our again, the lung pause value and cancer I/O in activity, observe as We path, prudent melanoma, it development results unlocking that EXXXX. at our near-term the possible recently presented in time could Syndax. non-small of we spending early to clinical molecule development cell have was such could excited Nonetheless, it's we further receive about significant clinical until data We single-agent positive

year. dose disease on remain versus efficacy we II track later solid in XXXX, initial end and For having a of tumors, select in to recommended quarter host Phase this anticipate in graft the chronic

our Finally, into for technologies additional molecules we or continue to bring look to portfolio.

delivering We pillar this on have strategy, is our I a of believe proven a track our record of of strength this core and company.

sites the like most As patients, collaborators always, and I'd to our like thank for with trial With team here at the call open the our program. questions. Syndax, investigators to I'd involved and clinical importantly that,

Operator

from first [Operator question of Bert BTIG. the Instructions] from Hazlett line comes Our

is open. line Your

Bert Hazlett

that, of differentiation AACR two, Thanks was maybe the some on for taking and syndrome can to differentiation program? There an target with that was expect maybe the or considered first Menin-MMLr question. you see at discussions if have program. was with regard And syndrome to Menin so, have? I that on unrecognized with that therapies. AML many therapies, seen many on an phenomenon be those the of under early AE the for you program Would recognized with the

Briggs Morrison

Bert? question, second your What's

Bert Hazlett

Second there question regarding translate activity ability Is melanoma? entinostat. is in the lung an that biomarker cancer cell you've of selected the for biomarker non-small to

Briggs Morrison

Okay.

then So Peter second I'll the over take first to I'll Ordentlich take to one. one, turn the

cells look what the leukemic at before think treat the to turn inhibitor, the die. we happening they involved leukemogenesis so we MLLr when off believed we is genes if in of So the with differentiate are do syndrome, differentiation again, biology expression you of and cells

that to Peter, upon any differentiation of end its to others. kind And rely about I IDH melanoma. Whether would applicability I we you turn we the and monocytes I'm saw So the, efficacy, I'll is much think you accepted surrogate evidence sure, the inhibitors Peter with complete not so see your is it of regulatory if question wouldn't point think to that the for second responses. of over syndrome just rather and some shock want us, around question comment if Bert’s

Peter Ordentlich

monocytes hi. of in prediction cohort. melanoma yes, is terms we see cohort lung do The as in we in baseline Yes, response, short the the in trends similar answer the

Bert Hazlett

would follow-up, based that And continue enrich biomarker a just way these you some – to melanoma? if on programs, if as you to choose in expect you in

Briggs Morrison

is take Briggs, Bert, this I’ll that.

we yet, we've mean, better So durability characterize the that potential that we biomarkers. characterize the or further, I and don't mature using letting of of so a were that decision think that I made obviously was the could part reason the melanoma we data could other bit monocytes both,

a don't but with But program. too So of consideration, those that forward probably about it's details programs, the either is whether of certainly much to go until one to would a we say what consideration. decide exactly something that it have is be we've

Bert Hazlett

Thank Okay. you.

Operator

from of Baird. next comes Kumar from the line Our R.W. Madhu question

Your line is open.

Madhu Kumar

for guys, taking thanks Hi my question.

therapy, while off when So first as plus to of what come and that it on so, in go on continue patients if the had that progression can entinostat entinostat therapy of protocol, XXX, standard in ENCORE on on who the protocol care. entinostat post-progression. patients at case? appears a to kind arm is exemestane drug the we allows are progressed stayed one to of were control patients the back looking fraction And who looking maintenance arm therapy through Is

Briggs Morrison

your about Madhu question So XXX. was ENCORE

Madhu Kumar

Yes.

Briggs Morrison

don’t that know, to question? Peter, you I answer do know the

Peter Ordentlich

it, the I time entinostat All who patients progression. the on don't progression. at – disease on nobody came of off continued after was

Madhu Kumar

reconcile you other in exemestane of do that how for example, the of about when you kind kind And trials? it’s clinical clinical other in the that versus XXX And placebo do about other arm’s the exemestane the and ENCORE to performance of monotherapy ENCORE then – think relative trials? performance arm, and entinostat exemestane arm how think great. you BOLERO-X guys arms terms of placebo Okay, XXX in

Briggs Morrison

Yes. take Peter, want too? that do you one to

Peter Ordentlich

that that think got thank read data and using – if central BOLERO-X assessed on arm good the and Sure, were thought magnitude. It's of had remember data between a about bit wasn't the control control investigator can’t quite and was that differences the different the or for what not you. too a we other off, read we out that But assessed few out what the BOLERO-X, arm far we’ve as the trials terms and I question exemestane. our our I It now. quite in exemestane right a

not So that. the fact, if to spoke we recall the by at on the And much in non-steroidal based on we very actively time concerned prior investigators XXX, fact progressing in their enrolling inhibitor. aromatase you patients were were

So tended to inhibitor aromatase dose their to the resistant activity. thought was more be that perhaps

So have really much outcome. underperforming where investigators sort comment recent had at populations the had the can’t that just median may what concern that of very was – surprised bit. least at not overall, But trials a that really shifted exemestane significantly. patient were out a we time more arm, I read there the at the for on control as ours wasn't

Madhu Kumar

I If in. can more in great. squeeze one Okay,

the of showing kind guys is So they of IND clinical the of biomarker think interaction? filing the PD trial innovation pretty that kind or What thinking Menin-MMLr formed. well about Menin-MMLr for you now so inhibitor, is do best plan

Briggs Morrison

Yes.

much said diligently we're So think on the Madhu, I PD as we've assays, of working question. answered I Bert’s sort two those, don’t about

that see responses. is I clinical get to candid, excited most would think complete the thing be us to

Madhu Kumar

taking for Thanks great. questions. my Okay,

Operator

from Our the Cowen. line next Chris Shibutani question of comes from

is line open. Your

Chris Shibutani

you as XXXX, With potentially are least one of think the clinic going clinic about context. for you're into obviously compounds think compounds helpful one help to the is there several taking? that or much. you. is Can at how be or very you us the its I differentiating molecules well. the It’d think of it Thank and go approach either Thank that the should about in themselves we that’s

Briggs Morrison

Chris. a Yes, lot thanks

early probably molecule differentiation, they’re to I So to that at, would think broader publicly, the much to said assume think early that it's target an both approved. think their believe available, we I much from what out ours be agents. don't because say know MLLr, program exactly put IND the their similar this But two, they mutants, their between we're I program, the hard able – exactly forward. it is point at they what the at tell as looking does. I what – referring that think great they're know differentiation from point for We same publicly time molecule populations from And differentiation in focused to NPMX between you're some in And people I they I their studying taking Cour’s population. had would too on do But molecule. which be they is say about say can molecule active all-comer have would hits that a the it's to – figuring to little said I a what's ones to little too search also the maybe be it’s, we two the too

relevant So now good they more question. probably and efficacy data that have a when six little a bit, months also maybe from have is we

Chris Shibutani

like Great. you. other that you be in mid-XXXX read confident money your also from for And on you event the Can It if about done your you did plan on smart EXXXX the talk that once noticed the the about perhaps how feel until business [indiscernible]. to event development does a need front. financing behalf. in out did, board Thank understand for the to to be you get-off then considerations recent mid-XXXX, helpful I brought because certainly about that you on to instance not current would that feel search continuing talk we some

Rick Shea

it’s Chris, Yes, Shea. Rick

further, anything at prospectively. provided for slightly we in give cash that us of end year's a time worth the in which XXXX, the guidance more than with would should range without XXXX burn $XX Given cash low-to-mid million that we doing cash

to But QX certainly, we to still pretty probably we'll result be shape the at to attention time and that in pay of EXXXX cash. have should to frame a something given it'll be close have good time. XXXX, a So amount have of reasonable

Chris Shibutani

you. guys Thank update, [indiscernible]. to you getting Look Great. you. forward when an Thank

Rick Shea

Thanks Chris.

Operator

Marai next from line Christopher Our Instinet. of the from Nomura comes question

Your line open. is

Christopher Marai

question. just Hey, wondering And compound. good assuming what first plans – afternoon. delineate you've from the for with entinostat, Thanks us and point success, the could I’m some points, for this made to taking commercialization the then you on question to with And on if would Maybe May. respect geographies, progress was future to around of partnering for in then continue be to potentially you secondly, would respect commercialization? open one plans thought the your to some that processes commercialization? us assets? different walk be then the you. Can And Thank there through of you I follow-up if I

Briggs Morrison

question. let Chris, let So that Michael me take Metzger

Michael Metzger

Yes. Hey, Chris.

of pretty in So do U.S. well. the in for probably that commercial opportunity large have we've think of aspirations optimize the has global with the partners of been in terms commercialization, U.S. Pharma I in a outside terms our with time about discussions but own launch the to which And partnership we the as the or had extend potential launch. reach over a open our drug we've drug to our doesn't potentially on aspirations, either own fact

force what opportunities, we data think – So to And I build undertaken have work are at we emerge. is we we're our been And opportunities that not to of think as internally have sales globally. a are I in regionally eagerly has waiting partners yet. partner or the either not to for multiple so mean, terms we of far, have we'll as – time

in field that's done. company would bit we've – hire that our waits so likes typically something not force, longer burn. Syndax a Clearly, little it's to small think not I a forecast

you done everybody prepared have data work comes expect. We would pre-commercialization well take And point. step that we'll think we're at to in, some on when and I the the update front next that as

Briggs Morrison

geography? on comment to want You

Michael Metzger

Yes.

as also the some so they of of And rest U.S., and we would of all partnership potentially in the in then certainly and take geographies as China are help in geographies and marketing the a or including U.S. interested of launching so, open the part Japan outside but meaningfully in Korea the are the interested we and I U.S. where comment said, and most us be have now, part open about I globally geographies, sales and – other in to well. partners think represented we being there and would the terms

So how options have to we out. some flex depending make on we

Christopher Marai

Michael. Thanks,

down respect obviously success menin to different could aspirations could the to road, obviously that, indications. Just with if maybe have have salesforce? be your mean, own further advantageous, you on you it elaborate I with

we about that? his So about that? how How's Syndax should be thinking thinking

Michael Metzger

Yes, I it's know a great question.

we're enough breast I indication. companies our small XXX have in in think indication. well this through reps breast its numbers do have if in have cancer in grown breast on reps launched or process, cancer round portfolio it's have Companies so, of and fortunate big a cancer, own, launched to up that can XXX roughly

there, and are specialists all not there so is inhibitor, overlap that's centers like there a for So oncologists unattainable some certain would that we and company would small Syndax, leukemia, but they're some – who on. the academic menin obviously we focused and focus on

that's headcount need cover and to marketing and sales a probably smaller in terms a space. So of leukemia the

bag. it promote outcome and drugs if one would doable certainly a So we in to had both be great

something – we'll actively Certainly that the about we're to. yes, so thinking when time we aspire And be comes.

Christopher Marai

and to of then to Got it. just data then rate Thank on maybe you you clinic rolling. roughly get me could in might that that menin, how once with include and much. sounds things next in very correct, like response see patients And the looking the you. Thank that's remind data we about clinical the a follow-up a first you for data respect we're update if other it few many questions, set

Michael Metzger

Yes.

program the and we X know is So or Phase exactly IND looks that, on Chris, accepted Phase just comment what X let until me like. the

off in, giving just things about I can we very many think patients like on that. – when really we'd too how rather and say hold much much

what IND accepted once program. exactly know we'll more terms in the the our and So of is FDA say agreed to that about is much we clinical

Christopher Marai

Got it. Thank you so much.

Operator

Our next of from question David Stanley. the comes Morgan Lebowitz line from

is Your open. line

Ishmael Asante

some more give the and our is menin for consider? should versus you be the logical this expect Ishmael hear XXXX, for would just to more specifically David. Thanks. the for Thank combination combinations monotherapy guidance question. for considering Hi, on on the to taking which IND you the opportunities strategies when we inhibitor, Piggybacking mechanism on can

Peter Ordentlich

Sure.

position a in probably So that filed the to I detail I variety There's be sense the program to think, obviously the think different the combination would program and we'll what IND exploring. line. the further and be could convey able initial a down what much about IND we'll little after really on the I is until about that and more of monotherapy is we're be But accepted in in is think just don't combinations make thinking say more monotherapy.

Ishmael Asante

Thanks for the data second the efficacy XXXX, the Okay. Thank the data what should from of X for the you And us to we type half. expect for of in color. remind see Can you. Phase separately study? presented

Peter Ordentlich

Sure.

So have up again, trial just said specifically we've we'll a to set clarify, dose scientific of as a I GVHD. don't trial is presentation data. that The know patients with escalation in

tool getting comment we're we versus sort you use of patients efficacy. be a disease So efficacy using can what on graft and numbers both of the combination small accepted host it's assessing safety Michael, efficacy. and the of There'll for chronic or

Michael Meyers

used tool Yes, assess it's standard a to GVHD.

patients with all at instrument. responses, GVHD based not or response, consensus on systematic based for and basic any associated its anticancer specifically the it's tumor it's type So on multi-organ

Ishmael Asante

Okay. thank you. Great,

Operator

open. Harshita B. Our comes from from next of line your the FBR, Riley Polishetty question line is

Harshita Polishetty

everyone. Hey, good afternoon

with have you've NPMX you indicated patients who MLLr failed to me, that your therapies. regard and Just one inhibitor menin leukemias, are targeting mutant from question and initial

first-line for have mean, some provide color well. challenge AML is with treated obviously mentioned patients could you induction I you they these the what previously hoping are that essentially was the additional initial therapy patients. but is that for or respond I don't ALL, option these I on So think

additional response info any So the and of would for subsets on like duration in response what rates looks patient helpful. Thank first-line you. be these

Briggs Morrison

Yes. much thanks your so Harshita, question. Hi for

know are to with generally standard and patients of their patients chromosomal The physicians just patients from I’d analyses mutant So practicing today. all are conventional clarify, therapy who and both their sequencing. are treated these will from so MLLr NPMX

have a have are just details therapy as a therapies. would we And rate treating anticipate, we'll part And anticipate newly The have of with most for being that any would patients high is these that standard And so have go ALL approved, and tested standard main both the diagnosed remission diseases. but patient again, challenges bit they once little induction and target IND AML. we we or patients will they in therapy. moving course, would agents there so one a of the failed relapse again, of into more who new receive

think have to able we'll and they onto approved. failed once IND regimens what I had exactly So say about previously be the trials, come our patients more that before is

Harshita Polishetty

you Briggs, Thank that's Great. helpful.

Operator

Our Instructions] [Operator the Citi. of from Beatty next from line question comes Joel

Your line is open.

Joel Beatty

Hi. my Thanks questions. taking for

entinostat, breast XXXX Phase the last the final discuss, protocol the The is could there is analysis? for that on first definitely analysis, the QX trial cancer analysis, that X or is the in one will could potential it makes what be you it go a that past

Briggs Morrison

Right.

analysis final are protocol XXX what specifies there the the events. is for way when the So trial is Joel, the

is would say it where could could driven final that's spring of end think event year occur when an or year. next our this the in we analysis. upon the it Based the we be be as modeling So the at early analysis of XXXth event of

analyzed, specify of will events. not – a the it's protocol the that the specifies So time doesn't trial it number be

of events XXX the question it how accrue. a takes just it's for to long So

Joel Beatty

so what another further spent Then far futility and Thanks. and question overall also the the trial, Thanks. it. for analyses remains set the could survival you discuss remaining alpha been the analysis. Got of on then bar that's

Michael Metzger

Yes, the statistics trial they think in don't that specifically the that describe futility. that think, rules of I went trial. around and there's so the publication the the into overall design publication a describes don't But I

rules public sure point the that's is the have people hypothesize of I'm I in rules described domain, trial. that the can in below to use But trial. as been this So evidence the achieve hazard you not XX% estimate, that public that ever for ratio that the formal not considering that going some imagine don't domain a some people use the you're think positive point any at all standard

So think second your I part of I – the your forgot question.

Joel Beatty

so and and you the what think part the also spent have answered alpha futility far on remains? then I

Michael Metzger

know all the events, you interim but how overall each analyses ever exactly to we've alpha if you I modest amount doesn't of to spent that the of very add have interim to much. final spent go XXX up don't analysis, through at those is So the described all relatively for go a and alpha much it's spent. of

Joel Beatty

you. it, thank Got Right.

Operator

Dr. this no turn now I back Morrison. will We at the have further time. to question call

Briggs Morrison

for feel Chicago have you the many you along way, questions again, We your everybody I meet to of month. thank questions. we'll if of all other up joining please you this us. call. later for assume you contact with thank the any Well, in And free Great.

Operator

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

now disconnect. may You

Syndax Pharmaceuticals (SNDX) 6 May 192019 Q1 Earnings call transcript