SNDX - Earnings call transcript Q2 2018 | Syndax Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Syndax second quarter 2018 conference call. At this time, all participants are in a listen-only mode.

Following management's prepared remarks, we will have a question-and-answer session and instructions will be given at that time. [Operator Instructions]. It is now my pleasure to turn the conference over to Melissa Forst with Argot Partners. ahead. go Please

Melissa Forst

and Welcome to joining operator. Chief are this Officer, you those an with the quarter Officer. to for joining with Chief on Melissa is Michael Thank Chief our Partners. you uptake the ask us company's Financial Argot on and and call Chief deck for Briggs a results the Dr. turn Executive you is This And please the being financial second Syndax's us review this to webcast progress results. Ordentlich, Shay, session today a line of the slide Morrison, I'm website, slide Metzger, that a Forst Rick afternoon you, me of thank and so call operating statements discuss and company's Also afternoon provide by the Scientific forward-looking to on Officer. Peter Operating has I'd on accompanied to two. question-and-answer been and President Officer posted and

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

Briggs Morrison

mission on quarter and Thank the to as and you Melissa, second very This webcast. much, people strategy cancer a our progress realize live three us primary longer support with I of share in than ever during Slide thank everyone which to and future afternoon, our – highlights provides investment we've of the made summary we continue corporate for Syndax. for today's on better in before. the execute call a joining to will

milestones clinical our cancer antagonist. review provides Slide and upcoming that milestones ENCORE trial for program, on strategy of will received breakthrough I'll with FDA last the the the III upcoming on May to therapy which exciting in positive I four I'll plans call, PFS, this our discuss commentary program we're well breast or lead entinostat hormone entinostat the During clinical progress a for our development entinostat call we combines as some trial our our survival, the from for which designation communicated SNDX-XXXX, readout Phase anti-CSF-XR a from back of making as related XXXX. with progression-free provide the antibody. PD-X the summary receptor both review

lot company. our see, time transformative potentially data reading the we of period, a a over As you can out have for definitive next clinical

our the will It negative breast Phase now trial HERX Slide update me slide of give trial. turn the positive, also entinostat receptor summarizes key the milestones. summarize endpoints an and in the to design Let you trial and five on hormone III cancer. upcoming of five

XX% these enrollment anticipate we file we four completion six Safety enrolled this results the of the of As analysis. the completing final trial. two by interim completed ECOG ECOG-ACRIN And final learn be of communicated of data We completion an be released enrollment. of are enrollment. progression-free overall regarding communication to is quarter the No of the the will analysis of what if analysis of Monitoring Data many this last the of by from survival held next Once have of the year, months poised confidentially receiving until NDA we ECOG-ACRIN. in final communicated is as about previously, and the of months statistician now analyses at Safety are end fourth within Committee. survival enrollment received the Data and sometime in achieved, will this the will about quarter. study questions The July time first PFS we to and Monitoring end trial And exactly Committee positive, the the the analysis the

So, not the Syndax the any receive trial simply communicate will is analysis to clarify, data met line positive, if met, interim indicate an the results when If next will be was top meeting. not communicate data PFS medical at will and Syndax the presented analysis full significantly PFS analysis and appropriate will be is that conducted. will PFS statistically not and from OS

communicate enrollment. not completion will of We

all show that and We will significant Syndax. will the interim both analysis. would to therapy many PFS is the year. I'd trial based it's a November. that six will a people thank finishing any communicate I'd of could interim will Phase made be at EXXXX breast the results potentially who is potential updated breakthrough trial end cancer led overall women In The for overall for for have be always trial full therapy for analysis results survival must top with like survival presented released of Safety of like confident Should but to would what benefit, the reality. statistically Committee to as overall moment we the you of FDA of to simply extremely analyses data a trial remind medical months, any say and be communicate III again result also line that Completing and examine be an gratifying, survival appropriate survival designation. this every truly riveting in generally data a scenario, next next ECOG clinical at the remain this trial overall is Monitoring hormone and Phase the the scheduled November take Data meeting. thrilling. to I a breakthrough which time We it's Syndax. II upon strong in outcome May

agents, at to women the and the importantly, potential in Our our at research her clinical community. responding a there's cancer. many Slide breast to the therapy CDKX, with increasingly at has the We Ibrance, preferred most HERX for thank the emphasizes most of landmark a here patient this know medical results sites Syndax, negative therapies want CDKX, a the six notably ECOG to but stopped trial took colleagues for are look CDKX, be investment of X I Perhaps, who and HR clinical the understand desire who colleagues to involved positive, families entinostat/exemestane regimen as after will effective a to be the We in forward that clear sharing used what therapies, hundreds agent X part and trial. in being first-line their X trial. inhibitor. the

on receive to receive relatively be is patients go and first-line of large Our prior current CDKX, XX% and after estimate X and a will failing who could, highly data set therefore, therapy is with entinostat. XX,XXX received hormone eligible the population that relevant entering This EXXXX have somewhere between inhibitor have we population. therapy will this thus trial, to in of to an XX a patients estimated in patients potentially

turn ENCORE seven, program, entinostat now combination we're me antagonist, PD-X trial antibodies. with clinical which in PDL-X Let slide testing pathway to summarizes or either in which PD-X our antibodies

cancer, in PD-X is entinostat different to have now positive which hormone stable yield of antagonist colorectal combination patients broad combination six exploring are results. ovarian lung exciting effort a identify as receptor – is biomarkers types cancer, cohort science in This with experience program We previously cancer communicated, an extensive an negative starting breast cell that clinical will triple predict designed cancer. benefit program breast is trial that, by preliminary therapy, melanoma, non-small we from that cancer, supported microsatellite [ph] clinical and a to our tumor could

clinical encouraged we seeing We by this are results extremely across program. the trial are

our competitive each on type, in will our upon generate clinical an complete to need, based prioritize to the we cohorts trials investment. half in enrollment XXX, of and first both ENCORE ability in return we which tumor two registration unmet landscape during XXX ENCORE medical three to report having to indications completed this of enrollment of we've XXX. the As initial and the advance attractive year, trials our that I'm as completed pleased well as

entinostat patients the Lung treated with year, the and combination As I of where the we is first three have we ASCO this out of summary months. data At for presented XXX. lot in coming cohorts There benefit. program eight a Slide a this reading XX will their with will cancer a classical were of of are pembrolizumab previously, ENCORE prior utility in this for progressed on we who blood in noted brief presentation of the non-small clinical who from data definitive a that to had full Conference presentation also lung be oral antagonist. an peripheral patients the on That on September this updated year Cancer at provide enrolled XX on the patients cell data cohort. of on PD-X World derive monocytes enrich

at high we classical PFS patients a XX% brief a presented As baseline. response in data in saw approximately rate the XX% the a with at ASCO, median X.X reminder, we blood month overall and monocytes of peripheral

any PD-X have cohort year. indication this year, classical the who have registration Coming antagonist. end communicate this anticipate in of with a XX We we quarter. Updated anticipated agent who progressed on be development benefit by and of clinical who for and this we in will a enrich treated the ASCO, progressed their we monocytes the communicated, ASCO were seen is derive utility the presented antagonist. provides a peripheral decision in PD-X CTLA-X on Also plans for who and a our combination this level in And patients of to fourth have year. on by have for both combination we efficacy of prior on patients of patients or metastatic this had XX that entinostat entinostat we CTLA-X blood PD-X previously pembrolizumab seen also of expect the the entinostat making data and and a cohort as of both antagonist out our the pembrolizumab data not at end the with first to plans melanoma patients the examining from a a in full

data combination for this patients a cancer, year we another of unmet on microsatellite stable ASCO who colorectal area were clear treated at pembrolizumab Finally, XX with of and metastatic entinostat also presented medical need. their

randomized, XXX and ENCORE II complete whether decision emphasize are of for that inform either half physicians the to these Syndax anticipate a ENCORE the with Phase provide cohort total enroll XXX expressed end this of utility XXXX. XXX, patients from breast trials. program we're now making patients these that in Slide trial important nine clinical cancer. to of in evidence of XXXX. by report could trials both indications. pleased that I XX and could pleased first and summarizes the Positive of the entinostat and conducting design expect of populations. the and are of We additional who trials registration anticipate our in first has by half breadth this we I'm and ENCORE blinded, a excitement enrollment these XXX in want the triple directly placebo-controlled negative trials of trials ovarian potential that from transformational in clinical to enrollment our results both very topline Again, and trials in have the to of on cancer will both these completed robust prove been results quarter

best-in-class clinical ascending in to We healthy trial study this previously year, SNDX-XXXX of provide We underway. with had to our an of and program our study potential turn In the our with combination January is were CSF-X now cancer on is Phase we multiple XX and IMFINZI, the volunteer receptor. slide data combination announce that SITC midyear. to Let the that update XXXX in indicated therapy we patients ongoing. now around the I monoclonal XXXX at SNDX-XXXX, targeting me development antibody presented November pleased collaboration very for now and AstraZeneca of dose

patients complication XX chronic anti-CSF-XR of trial. a development of this Given frequent clinical target, of SNDX-XXXX macrophage which the outline fibrosis contributes I the graft-versus-host This blockade to modest this first study the cell of a if unlock the as shown from significant year for least, of on Menin-MLLr other activity pro-inflammatory CSF-X, trial symptom. It's of extremely want on for CSF-XR is estimated remain attractive positive first well trial data graft-versus-host in of treatment half which for IND anticipated results found AACR, safety to stem manifestation slide we're We of we per the to Menin-MLLr PDX models for and axis trial advanced disease. an the SNDX-XXXX. PDX our that mutant agent of anticipated initiation development molecule this spans that opportunity broad aspects chronic of disease, we value specific Testing graft-versus-host single that Last, developing and the NPMX transportation. slide. against time and which is described indications we program our Today, completion the summary certainly and antibodies believe graft-versus-host disease those inhibitor. I IND-enabling donor donor-derived XX,XXX models disease, for a of of efficacy range to we this disease. pro-fibrotic disease could upwards chronic provides and syndication. graft-versus-host this on brief both genetically-defined an as in studies initiation macrophages, website. reducing successful of for to anti-CSF-XR disease preventing of be start is of Exciting demonstrating efficacy are MLLr leukemias to test can and year. This to that the of our suffer pending filed XXXX. hematopoietic at our the have on IND we testing data many on an that summarize pro-inflammatory, program, an of potentially well and announcing working to inhibitor that single need, with globally and demonstrated at and not investment on these represents believe, positive, SNDX-XXXX of chronic chosen a significant SNDX-XXXX XX, but for chronic straightforward presented disease a a presentations clinical the agent rationale see emphasize depletion provides in as the the separate many our and rapid path models, The was competitors Phase unmet we've preclinical development year's our has file activity. who have thereby Slide track Based

rearrangement. possible the could value It's course, activity that significant who have target very patients again clinical of an We will, MLLr for path, Syndax. unlocking in development we quite clinical observe early

tuned it the really, I'll this And So, stay program. on that, update. with financial turn for over to Rick

Richard Shea

you, Thank Briggs.

Turning net June to to $X.XX share slide or for the months ended $XX.X reported million $XX.X of XX, per for quarter. to XX, or per prior-year XXXX, $X.XX attributable Syndax loss stockholders share million the three a compared common

entinostat increased $X.X development the for in million the XXX offset research ENCORE program by of increases increased G&A second of also due increased activities entinostat EXXXX. for increased quarter due compensation entinostat activities prior-year. for and was completion the quarter and The increased million increased for to SNDX-XXXX, pharmacology to primarily $X.X Second Employee Menin increased million expenses. from partly totaled for pre-commercialization due expenses for clinical $XX.X headcount. legal prior-year. cost and and patent-related The compared increased XXXX trials to increase expenses lower $X.X the to the were development million primarily costs activities manufacturing to program for CMC program,

stock not warrants. the a exchange This X BVF of agreement in-the-money held Value stock and As the shares was of but million XX.X stock outstanding including an X under options an million XX.X shares, million of shares. by basis, of a signed sale million In Fund, common shares June BVF, June for XX,XXX for outstanding fully outstanding, diluted common shares common end to XX, million stock method. at million share XXXX, X X at from warrants company June shares the issued million with using exchanged On shares million there from the common the were which by Biotechnology we warrants treasury common of XXXX, and XX.X XX.X XX, purchase had exchange BVF QX. a reduction

earnings are compute per in shares calculating company's the the of to of share. share, the per purposes used average weighted net number the warrants loss For included

XXX,XXX reach Subsequent financing of ATM of to the $X.X impact the XXXX, to going of So, the calculation milestones. is million. development key with pursuant sold EPS to the enabling for at quarter X, the million, believe forward. company cash through balance XX, stock development $XX.X warrants fund has third August will net with which our June months, XX we Syndax in of second not to quarter ended common of sufficient shares facility, proceeds least us

our Additional file in this financial intend XX-Q available week. details to will which we be

ahead, per numbers third operating compensation Total to call million for for from quarter net for the $XX burn to offset quarter to million over XXXX. $X.X we third $X.X proceeds $XX the be I'll be Briggs. the and quarter. The are the million million facility. total by expect the turn now million will be approximately back Looking non-cash QX full-year include expected million $XX costs ATM XXXX of million to in sales R&D expenses And million cash stock expense XXXX. in operating to the expenses for those million $XX to $XX and $XX to million stock using of $XX $XX

Briggs Morrison

Rick. lot, a Thanks Great.

So, several slide we milestones looking ahead, upcoming anticipate summarized key on XX.

in program ovarian cancer. cancer, breast well in this colorectal cell non-small next well investment negative definitive receptor Phase PFS as triple we of As data as cancer in year, decisions readouts November the six hormone anticipate ENCORE in of results our survival on readout negative III coming in The data cancer, from the I've the analysis as trial melanoma, breast from and cancer overall our and HERX indications EXXXX as clinical the noted, months. positive, lung

it's be thrilling earlier, an said I time absolutely at As to Syndax.

it's Phase a matter next months think at busy trial five few unprecedented will so period. company Syndax. and for Phase data a months. have such almost here much our III coming extremely of to us over an of I a be over size for short out trials II It

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

Operator

[Operator you. Instructions]. Thank

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

line Your is open.

Chris Shibutani

this operating updates. expenditure the well operating of the sense where you very R&D. we first expense us and year, for from this push represent into Can and a half following we now for should Rick, as or about out in that you're for also of reduced about data Great, the the into or of Appreciate next levels you some year? much. does think have thank Maybe borrowing sort delay balance as talking that XXXX you're guidance of readouts perhaps how XXXX give

Richard Shea

Yeah. the Chris. Thanks question, for

we we would mature, XXXX XXX that Our of would evaluate study. a sometime unlikely ENCORE which be earlier in it's year-end. Since the commencing that of indication, weren't one those follow-on least we data follow-on it program. we're And second at but be and to clinical studies that letting felt prior guidance anticipated study be half our we to continuing starting starting that to sure we'll one exactly

XXXX. any of pushing costs out that's So, those into

Chris Shibutani

new Great. And news. the then,

you area well antibodies has it vulnerable function When looking As edema, think included about at sort chronic is the make of that related be the dosing preclinical about comment the what tumors to – work perhaps as far relatively speaking, setting as things related pipeline you environment in would might broadly work particularly patients issues. AEs, cancer graft-versus-host? pre-IND off-target Can you it we CSF-XR orthopedic that either the about, development, or in of such as learned way to efficient the probably in amenable mentioned that to from complicated have of periorbital liver CSF-XR, that or to test approach on-target as they graft-versus-host. at perhaps your in some benign explore had an that issue you think looking

Briggs Morrison

Thanks, question. Chris. Medical Officer, our take Chief I'll Michael Meyers, have that

Michael Meyers

Chris, great question.

achieved an edema and considered issue seen allow more we've see the the to abnormalities until frequent would lower liver may at tumors. believe we that dosing. that would be significantly specifically is function efficacy treat us what to what need periorbital to the don't So, to GVHD than solid be be And doses become indication higher,

Chris Shibutani

you. Great, back thank queue. get I'll the into

Operator

Thank you.

from Aprilakis Konstantinos JMP Our of next question Securities. comes

Your is line open.

Konstantinos Aprilakis

my afternoon. to follow-up taking questions. I Chris', thanks And for A if may. Good

pursue on inform potential landscape this thoughts your the of did your that how So, in competitive a to sort and GVHD as decision indication.

in was do of number fitting got late-stage XXXX potentially Where see Imbruvica assets clinical in? you trials. recently development, You've approved. active

Briggs Morrison

Metzger have question. I'll take Mike that So,

Michael Metzger

Thanks, Konstantinos.

So, really good question.

a of chronic GVHD. I think lot second, opportunity, line there's third in

approved of after line. BTK, I think as has Imbruvica you're the the second line first, the agent use been first probably in aware steroid

sort Other of line So, other approved. that necessarily only in tested, really being been patient second the are agents small distinguished Nothing third has but one used. than that's the inhibitor. numbers. They've itself BTK or the

Naturally, think been I profile are achieve you developed. the distinguishes potentially you an distinguishes agents safety profile, hasn't a to and advantageous. a what a us that's that's profile that but being bar competitive safety have So, seen efficacy insignificant, show can tolerability if other is or that with

shot second I at line. a third think you good market and share have in

Konstantinos Aprilakis

just deprioritizing of an add-on oncology indications? This to you're just sake clarification, And is for not that? the the

Michael Metzger

correct. actually That's

have durvalumab. know, combo you as we So, on the work with going

the in far talk the ahead. said because do, prepared to too other things want start my competitive of about we'll as remarks, think rather about than I nature, that we to As I are they

data is we about. not cell in with single have thought safety to we in It's antibody. other this get from therapy way would any tumors deprioritizing really, or other think, and potentially that or things work efficacy agent solid fast-to-market So, a in way do good combination we

Konstantinos Aprilakis

thanks guys. much, Got it. very

Operator

you. Thank

question from Nomura Instinet. Marai next Christopher of comes Our

open. line Your is

Christopher Marai

taking progress. the Hey, the on thanks congrats for question. And

skins an sort Just or old thinking endpoint look a follow-up. on of more drug of opportunity look was aspect it skin Lungs, of specific CSF-XR, the quick at how have this at to the obviously, And development GVHD you manifestations, a traditional Another tend is one more that some to chronic and of get Do just and be look at that forward? and approach taking you I to the in macrophages then perhaps about manifestations? a because read in will do – maybe wondering then is one we of specifically? the GVHD? efficacy on I them, of disease

Briggs Morrison

So, I'll Michael let that Meyers take one.

Michael Meyers

Chris, we at GVHD pan So, scoring will the be to system symptom specific looking determine improvement. chronic

skin. We looking, biologic will be also such as areas for specifically obviously, accessible in correlatives

we'll So, of I without looking able looking to we we be PD is benefit the being benefit. at benefit, should think at PD clinical clinical doses key be be relationship – that pharmacodynamic determine at achieve something can correlatives which toxicity see that between to evidence and biologic the multiple clearly is also expect that and that significant a will we

Christopher Marai

And collaboration it. you driving an suppose, how focus. of diseases remind this AZ and Got indications the asset forward? look I perhaps your us with develop with maybe Is to with be, asset, collaboration respect have to to more do just eyes this at, speaking, and go you then, an Obviously, the do look or broadly? in to your opportunity you to oncology other generally oncology this autoimmune rarer currently going it or

I it. Thank and would try understand And to So, love that's that. you.

Michael Metzger

Michael. Yeah, question. Chris. I'll It's take the

obviously, global have think with I'll signed from that so and UCB. terms rights And of that we've we, clinical a you AZ, I it's our partnership it's So, remind with non-exclusive. collaboration in AZ

with in whether develop we're so AZ idea oncology compound preclude which into to plan the indications that to we that the reasons in oncology this and remarks. in chosen it's going doing with outlined from and and Briggs or non-oncology, others. any with a indication But here carefully does we've for we us his what potentially think other I do not addition it is indication, AZ means, can

that ideas We place hopefully have in and future. some in put the we'll things

tie fortunately one we flexibility, but cancer, in I So, the multiple in us avails type to us think of us that combination down antagonist doesn't particular place indications. allows in to develop option PD-X to do as partnership great that and have us put we gives

Briggs Morrison

are Yeah. it opportunities add add in Chris, not attractive the I to we should thing, would drug detract provide [indiscernible] we're that decide maybe in I in other developing oncology, from doesn't, we the only it. indications guess, from doing non-oncologic what but is those a way, precluded

Christopher Marai

Very helpful. Thanks. Thank you.

Operator

you. Thank

Our Hazlett of BTIG. next question comes from Robert

Your open. line is

Robert Hazlett

thank taking you Yes, for the question.

level pulling your as the of non-small biomarker you're one or to cell confidence there approach with a Regarding effort, actually could is your well? way and and indications sense has of and maybe data get cancer the another. – lung I'd that's evolving The describe across confidence XXX love you how matured

Briggs Morrison

Lung. presentation there'll updated I As an at be said, World the

end I think it's in Toronto of September.

data Looking with at the be presented it's we ASCO. generally consistent think that's what going to presented I there,

in way. So, it a seems to be maturing consistent

anything ASCO. think from I don't we data So, has changed presented confidence when our at

Robert Hazlett

pathway using studies, results enrolled? an ability for Perfect. And accelerated Is the and then, secondly, are fully of those positive? could you remind us about an Thanks. assuming XXX XXX now they're they that there

Briggs Morrison

very potentially We'd don't That's and then shows and a rather data we have wait what see answer know I'd the say question. that. the good to discussions.

it. neither one which yet imagine, of studying you antibodies in indication As the for we're approved the is can partner

the of two agents. have case you'd unapproved So, having

– entinostat – trials comparator the that clearly would evidence agent. positive if You have are to the adds

could a regulators, to registration be subsequent So, conversation tend we there I it path a a with but trial. to think think more of as

Robert Hazlett

you. Okay, terrific. Thank

Operator

Thank you.

comes Riley from FBR. next B. Madhu of Our Kumar

open. Your line is

Unidentified Analyst

is [indiscernible] Madhu. in This Two you. questions. thank sitting for Well, quick

can please second, walk in First, through at then, involved, And for rate more disease? the little mechanistic graft-versus-host has has you the previous been or any and it continued of CFS-XR the pace? chronic recruitment there preclinical EXXXX a rationale for change in inhibition

Briggs Morrison

about Michael Peter question Ordentlich have take talk – Myers the on Michael the So, I'll enrollment then – let preclinical I'll and the rationale.

Michael Meyers

therefore increased and three about past prior the will relative over the months, are this to XX% period, complete three six was that we what to actually, month enrollment enrollment rate quarter. we by XXXX confident the enrollment for very has So, in

Briggs Morrison

you few comments want Peter, And, to make preclinical CSF-XR. for a rationale on the

Peter Ordentlich

the are donor-derived Yeah, their lung disease disease, GVHD. shown fibrotic macrophage involvement both looked were one and into of that sites. macrophage those sure. at used of in determine chronic involvement, effects well as the role for those of skin sort donor-derived generation preclinical to models dependent Basically, of as of infiltration graft-versus-host in proliferation and it was experiments, both and CSF-X And growth those the

inhibition And in prevention both in the very models. of blocking was disease chronic so, both those antibody symptoms graft-versus-host CSF-XR of a of the and effective

really our So, data the main the with based that's ahead we clinical trial preclinical that on. moving

Unidentified Analyst

you much. All very right. Thank

Operator

Thank you.

Our Stanley. Lebowitz David of Morgan question next from comes

Your line is open.

David Lebowitz

us of trial, taking what might question. is of what type coming Hello. type And up? give expected given analysis considered be PFS a Could population? just of control you you receptor there my similarly, for then, the OS would positive another in hormone that for Thank be refresher the

Briggs Morrison

the assumptions I'll Right. and let the design Meyers Michael summarize were. what characteristics

Michael Meyers

Yeah.

were improvement, for hazard that three-month between treatment population. we and control be the clinically a minimal which ratio We looking arm or trend significance would meaningful three-month two be in benefit the the a to PFS ratio equated the between hazard a ratio considered patient with hazard survival about this of a statistical specific X.XX, for The would to – to two-month arm, specifically ratio improvement. about about a believe equate increase to be which in So, overall to required maximal somewhere hazard of X.XX. would

David Lebowitz

also? assumptions And for similar? be Would of what type OS, they

Michael Meyers

bit for OS. assumptions a The more assumptions the than for were actually PFS aggressive

approximately of for a significance. about about of to X.XX for a arm. the equates treatment months X.X being ratio improvement was ratio ratio the months for from survival XX we're OS And required hazard to trying control statistical to overall that arm five-month in a that XX about for hazard So, the achieve with hazard

David Lebowitz

for you Thank that.

Michael Meyers

of overall in as the XXX in recall, And months. actually was eight excess the study you delta survival

David Lebowitz

for biomarker analyses run melanoma, question, when the ENCORE the placing the just is be you you And, could are decision one more And made underway? where expect us XXX on Thank that. you'd your year, through for I that this focus? currently go later guess,

Briggs Morrison

Right.

go sort on at the that So, looking maybe, and then portfolio of you're through Peter, things of the classical comment you full maybe can monocyte?

Peter Ordentlich

Yeah.

based our the subsets regulating hypothesis specifically, cell we're cohort, on cell populations. the immune looking certain at of various For myeloid entinostat melanoma

for well inform actually tumor gene RNA action in And the up biopsies by mutation to burden patients majority and XX through Merck well a around fairly of non-responders, and whole-exome seq all treatment as NanoString think available responders paired, of as have expression large sequencing. I number, We that PDL-X as on mechanism us data both as pretreatment. conducted expression

think both I to be look blood in of couple tumor-specific non-responders months. over as well of the responders, position next a So, at as nice really we'll biomarkers terms in based,

Briggs Morrison

And just on monocytes? classical a the comment

Peter Ordentlich

rate. melanoma indicated, cancer for presented classical the ASCO the cohorts, in we are a and data was the saw same the we And both that or matures as also appear on and trend think, relative for over sort response the whether quite of see to rates from response lung to can we we we the But both lung. benefit presented, how trends perspective, So, to significant. that not for waiting terms at I clinical benefit melanoma, trend the comment as in for across strong the response a the to And lung melanoma quite PFS be monocyte we full cohort. of cohort before transfer rate clinical also

have far quite for lung at We're so also melanoma. benefit the yet clinical matching not high least, the we monocytes. And the sure

David Lebowitz

question. for Thank much you taking my so

Operator

the gentlemen, today's like this Morrison back closing Ladies and you. turn remarks. any Thank question-and-answer would call to I for to session. Dr. concludes

Briggs Morrison

the everybody communications and next look you're cool well period. you're call. I Great. Thanks hydrated all for staying We very if Coast. to forward the joining hope the East further over on much

Operator

program concludes conference. This thank day. Ladies may today's now have and you gentlemen, a great in Everyone, you participating and disconnect. for today's

Syndax Pharmaceuticals (SNDX) 7 Aug 182018 Q2 Earnings call transcript