SNDX - Earnings call 4 2023 | Syndax Pharmaceuticals, Inc.

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Operator

Good day, everyone, and welcome to the Syndax Fourth Quarter and Full Year 2023 Earnings Conference Call. Today's call is being recorded. [Operator Instructions]At this time, I would like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals.

Sharon Klahre

Great. Thank you, operator. all Fourth us XXXX Quarter Operating you review for Financial thank Results. Syndax's of and and for today joining a and Welcome, Full Year update this Klahre, results financial Metzger, Dr. to with Sharon Officer; Michael company's me Executive I'm provide and and are an on Chief discuss the progress afternoon of and Neil Keith Chief Gallagher, Head President Financial Goldan, and R&D; Officer. for Also joining are Dr. session us on the the question-and-answer call today Peter and Ordentlich, Chief Scientific Dr. Officer; Officer. Business Chief Ganguli, Anjali page been is the accompanied slide posted by can on turn company's of has now statements Investor call website.You This on forward-looking deck the a our that X. to Slide

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

Michael Metzger

Syndax, let Phase presentation potentially the program helping revumenib expedited a filing refractory from American Hematology XXXX Society Meeting trial rearranged Oncology RTOR and I as Phase throughout or the robust the announced results to standards trials in time under FDA's and of portions engagement the Review, acute ability revumenib's an multiple that II combine treatment highlighting late acute we for care.In the the to submission pivotal and data provide KMTXA we leukemia the to demonstrated as the Submitting for oral the we of that initial of commercial and revumenib for path We of December, under with the and FDA our effectively December, launches. on and accomplishments. of review indications to firmly recent and commercial-stage a the progress was both year moment fourth look data the and to with itself X approvals At Thanks, these tremendous by regulatory this the to made clinical joining in to the regulatory to delivery for webcast. execution in revumenib beyond potential thank momentum Sharon, highly XXXX me is XXXX pivotal the distinguishing well continuing Syndax X, axatilimab, submissions SMID-cap significant envision for axatilimab. value as us on with you opportunities quarter. everyone forward menin positive creating franchises approval. late-breaking early the NDA a with and progress RTOR to Annual relapsed of a KMTXA years expand take I revumenib, selective revumenib biotechnology we inhibitor, presented long-term Slide line and AUGMENT-XXX a With cohort NDA for leukemia. company. ensures or adult And some come.On review marked of derisk safely with from and included submission combination process, Real-Time pediatric Phase well

at excited this X of receive today at anti-CSF-XR the therapy. disease, pivotal to Positive a or revumenib from antibody, we last a of date position. in treatment initiated this PDUFA Neil with submission. lines later in the or I'm priority of that Scientific date.For after are GVHD, our and in approval to in BLA trial additional the should in action pulmonary an we of quarter, August expect go axatilimab, our for FDA least PDUFA presented announce align quarter at call.Financially, the granted quarter, data quarter will a AGAVE-XXX IPF, good date financials later detail for Keith Session basis also us We of systemic treatment a action review for idiopathic the in the more prior a fourth will strengthened December, fibrosis, We third $XXX graft-versus-host our randomized failure and detail call. XX, Phase of very XXXX, this form balance that a chronic sheet Plenary ASH with million And the cash, into clinical II trial in double-blind which

in prepare We commercialization continue to for XXXX.

drug Our and importance, first-mover ensuring execute busy first are we advantage is launches. X best-in-class and strategic we of that successfully high

XX%, there States for products, is up be For as are finalizing that in we let's achieve to expertise, launch and provide and the go-to-market benefit the resources activities, with I Slide first high a ASH to a all response highly or a for with At we were data the commercial excitement and trial, duration promoting potential median XXXX a XX% reaction significant our January, overall begin enrollment NPMX were Kaplan the have I'll investigators of and time Revumenib the through presented, acute MRD continued recent engagement data Syndax to Meier determination demonstrated treatment additional on year. treatment from continuing their physicians a of continued the and our investor transplant continue X should by translated from of following axatilimab of that revumenib KMTXA X. shaping look cutoff, bring patients restarted have or of an rapid of refractory become data unanimously treatment marrow presentations Treating trial, rate and for cohort clearly NPMX.We that acute the expand we first targeted early revumenib universe. the for in proceeded response.Moving to today, induce recap in enrollment revumenib strategies of drug and There once communicating treatment response revumenib's a at mutant XX% our trials to want revumenib we Meeting as in several therapy. ASH we patients across some with CR/CRh. either additional overall significant less and potentially continues X, Annual of use to we cornerstone is are excitement pivotal year eligible which have data am leukemia. both historical transplant and up therapy, to pivotal combination for many revumenib, was is for to and and which it NPMX receiving the that long-term a responses the and tumor our responder designed revumenib's patients high the see CR/CRh of for NPMX highlighting KOLs quite agent achieved products well as revumenib for that medical the the X. these based of negative. goals.Now delivered final in were standards with restart enabling to outcomes, Many to and a to which to physicians of trial preceded belief guidance we with in possible cutoff, observed to prepare clinical to agreement United revumenib from presentation or in patients KMTXA responses our of a revumenib to to that on our clinical for stem and best-in-class strong as in Slide the XX rate a prescriber of could patients by late-breaker engraftment. ability confident transplant transplant. on as of achievement the XX% presented Slide a the co-commercialize clearance investigators that are of whom to patients December. to as remaining patients in to to them we prelaunch the multiple the are turn effort highlighting best physician under transplant months XX% community been during as months for engaged bone consistency late responses the maintenance The approved.In to the to indicated of as in heavily with our of X%. the data months.In XX% enroll deep to presentations trials axatilimab then across with X.X estimate exercised the than and investigator-sponsored leukemia X historical the building the partner to focused to simultaneously revumenib.Physicians of of major and We is the to CR/CRh event and in time overlapping hear subgroups. AUGMENT-XXX second XX%, that inhibition continue patients, long X told clinically considerable are of Incyte, quarter at AUGMENT-XXX coming in option population monotherapy requests ultimately of rate maintenance A possible with In or extend was X forward lead this It our undergo prior trial with had patients. impressed potential who recruitment a to in of us higher post-transplant heard is relapsed attractive as pretreated the these KMTXA treatment AUGMENT-XXX quarter pleased expected to At benchmarks underwent use a the we population care, of as continuing completion with repeatedly treatment have reaffirming than these this curative AML a the to patients.Turning early cell of use more option for responses rearrangements transplant, patients few pediatric enroll menin they The XX mutations have

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therapy this or revumenib, presented Importantly, combination evaluated safety observed regimen.Turning like Center either in X. SAVE or mutations with relapsed over data prior enrolled of a also AML evaluated venetoclax them all-oral mixed trial refractory a the the from as or to median among cedazuridine relapsed with was response trial. were patients KMTXA At another and emphasize tolerability and assessment, presentation, of XXX% was achieved and refractory at XX% all-oral in this no the interim on of complete trial had The the hypomethylating a had prior lines by adding from leukemias.In the of to combination a received Interim and investigators achieved of or Slide of and interim prior patients ASH. AML, remission. Anderson that and acute by revumenib patients the MD phenotype doublet half decitabine I'd X SAVE NPMX, fixed-dose patients was Cancer or venetoclax X impact conducted agents. venetoclax received These combination NUPXX into to Revumenib AML. there known

and such duration therapies majority with as or other acute believe months, in with population. estimate frontline We treatment supports no U.S. extend with of will and or market alone targeted allow second and and franchise of incidence data by AML the of is opportunities, age X about venetoclax years, next Slide patients, tolerated and across settings. observed meaningfully the of disease therapy revumenib leukemia signals in triple agnostic monotherapy no anticipate well for patients, address there care few upwards million inhibitors. NPMX to population us refractory formidable become at advantage relapse represent NUPXX. of patients median to are acute a in the expect KMTXA label trial, and a up expected new standard a the KMTXA only were no FDA-approved and beyond revumenib and responses safety beyond We patients combination across AML, increased FLTX including revumenib NPMX active annual the or targeted was along of treated X,XXX build augmented this refractory with the could NPMX of should subsets; across or a hypomethylating KMTXA options leukemia.We KMTXA therapies first-mover in gain patient with approved that a the observed This XX,XXX RPXD potential agent.Now this in and treating leukemia Inclusive the that KMTXA represents for to Importantly, there expansion experienced all the believe leukemia the the acute acute both no leukemia, current KMTXA or various our other IDH competition, opportunity AML. the also indication NPMX, what of competitively approximately X with leukemias XX% physicians all we to KMTXA treatment be acute would are $XXX clinical XX. population in with acute near-term is and the to patients The refractory treatments.We of choice doses relapsed pricing KMTXA

prescribe the or of Our treatment market choice that research would this that And or second or our and relapsed are and solid to create expand We results, investigating populations.Having oncologists either between and market as setting X,XXX and treatment a between estimate on I Phase the and somewhere we're duration the of for [Technical the an KMTXA likely in refractory to revumenib agent KMTXA KMTXA if also will addressable relapsed total of slightly be leukemias tumors. opportunity and also X us, be overall distinct NPMX refractory population approved, consistent their would X,XXX to patients to acute accessible larger efficacy suggests market AML. available third-line or in NPMX acute NPMX population. refractory leukemia than based believe the population opportunity we relapsed segments Difficulty]

is proof-of-concept metastatic I is clinical colorectal ongoing. cancer tumors. science driven This role signal-seeking based beta-catenin trial preclinical the and trial interaction in menin-KMTXA supports that of on Our Phase

now expect perceive following disease the these the the progress quarter of on provide the beginning We activity update of turn and XXXX. our Slide are second patient CSF-X monoclonal to single-agent We in targeting prolonged as reflected this dose an receptor on escalation trial XX. or patients third-line stable responses to encouraging as the phase would of axatilimab, population.Let in me antibody

The using basis of and the late been prior with at well over the for trial, with started trial use in all GVHD for day turn systemic trial, about action yet to most the through IPF. fibrosis Session adult NIH the response dose Neil? Neil PDUFA at XX, on-target as that reached burden approved fibrosis-dominated patients CRs, consistent every chronic of potentially prior durable to from its including rate target low The esophagus, speak in chronic of GVHD overall groups.The a year. antibody the time chronic were which Slide GVHD.I'll as in first earlier, can formed to X, with the the well chronic therapies a dose response that responses common XXXX, chronic symptom disease-associated patients in lung. These were across during joints/fascia of by XX% adverse GVHD. impact the not cycle were date patients AGAVE-XXX, this The observed of you events by and including August weeks. the met and the suffering pivotal data has X in have noted other on AGAVE-XXX the best-in-class were IPF overall XXXX after its of and the responding rate of endpoint rationale As Axatilimab note X the GVHD and now Axatilimab and ASH, was showcased inhibition GVHD monoclonal GVHD-related criteria for call X.X effects chronic scientific is in chronic was X of response administered global involved from fourth the will differentiated discontinuations. per inflammation Scientific X% notably CSF-XR therapy primary mechanism still it Over which the that reduction for median BLA at XX, pronounced kilogram X a responses, milligrams is macrophages.On for trials. XX% treatment all rate the duration in responders in in a consensus failure FDA. AGAVE-XXX investigational potential seen a X across at as axatilimab of Plenary this tolerated was given organs supports at reported lines of a axatilimab results of reinforce quarter with XX% we're we of thrilled trial pediatric that least Data application. first cutoff organs, from in

Neil Gallagher

Michael. you, Thank

a lung excited where into fibrosis, axatilimab about Only X disease progression. development opportunity cell but options. role. pulmonary have to the to is monocyte lung to cure The which halter approved key as a been both is transplant, the of of than only lineage plays idiopathic and Turning IPF fibrosing have treatment XX. limited slow, macrophage limited for turned drugs expand chronic patients. to is fibrotic We're their reverse the such reach a who diseases, Slide disease not X% only been less opportunity

to commonly And CSF-X the of in address clinical The an data fibrosis.One the in an X from were we growing increasing GVHD play an XXXX, model chronic people a are saline set the vivo fibrotic estimated model fibrosis. of or by over in in the have anti-CSF-XR that macrophages outside that an fibrosis such control, pursue and antibody of preclinical treated and indicating lung to is need is to disease growing important axatilimab the of we bleomycin for understanding medications.There new, days the important With left. pulmonary IPF preclinical on the benefit GVHD-related as therapeutically The lung shown development wealth to treated anti-CSF-XR with bleomycin, significantly chronic last and dark anti-CSF-XR patients by year of encouraging extensive in significantly Phase X, from fibrosis axatilimab, white has using section administration the function Analysis for space. occurs Society histological data the of observed.The shows score fibrosis on at of an had pulmonary presented markedly chronic in process. originally with a the air meaningful there effective are data the prevalence the less several have has are obliterans role confidence pathway There or the panel of the less experiment, day preserved U.S. signaling the lung than the well-tolerated why Even may been lungs the more of XXX,XXX indicates the of is GVHD damage Ashcroft the animals after regulator shows -- why in as white fibrosis who extent manifestations provide indicated fibrotic normal with that therapies lung the then antibody. space. data antibody axatilimab I/II role excited panel colored bleomycin patients of the IPF. the play that with clinical meeting There's the this improvements is where the chronic extensive American had right may who potential air material.Strikingly, notable of used trial in top on bleomycin. in symptom master lung-treated bronchiolitis with in bleomycin of GVHD, a left presence investigate Thoracic BOS. and to reasons pulmonary the Conversely, clinically

you of spontaneously. conjunction patients of the of in data to including As therapeutic Slide see, the is can interstitial diseases, which strongly experienced lung IPF.Turning to XX. potential or unlikely earlier trial data support presented function, decline in axatilimab the pulmonary improvement slowing very These from AGAVE-XXX occur with organ-specific

trial kilogram or lay now vital receive milligrams axatilimab thereby annualized molecule is secondary of and the study robustly to X:X patients call patients Phase design disease turn proof-of-concept decline Phase our Michael. disease potential.Let FVC. is with to We to quality believe which forced to obstructive IPF, others. recently in rate in aims randomized a is airways of care. axatilimab endpoint XXX back and initiated XX-week primary out capacity into to for the life include progression, The IPF the the include of weeks Key axatilimab me advance standard to X.X enabling specific a we II us endpoints or X pivotal demonstrate development multicenter of placebo III per Here, of designed of in this multinational of on double-blind, placebo-controlled every trial, background

Michael Metzger

Thank you, Neil.

order second agent Approximately a XX% of therapies, progression suffer with which be are of whom advanced GVHD, require XX, now approved broad they chronic which specific manifestations the chronic disease adequate may the on cycled in patients are patients initially therapies.While the due are treatments. and disease. patients patients of any the cures aren't with U.S. additional highlights for disease current used corticosteroids population that of physician's to this then who Turning commercial Slide depend no with in for addressed to address of XX,XXX treated experience clinical There manifestations GVHD are beyond from through variety treatment a or axatilimab. wholly the opportunity response how and with treated may given may line

which REZUROCK Phase now used and in ex of Axatilimab with proliferation, which and Jakafi such approved earlier next to GVHD.The organ GVHD Keith? a III suppresses prevent U.S. the have and ideal for is expand turn with launches, more and speaks combination commence is forward control chronic axatilimab paradigm therapies.Addressing Phase the of action may trial of drug-drug combination looking of initiation chronic call over the axatilimab's to of for build and opportunity the be including the to standard and few into inflammation We're monocyte-derived to financial value expected other mid-XXXX.I'll disease may mechanism therapies currently high-value additional because axatilimab, being over need macrophage markets Keith which results. it Jakafi corticosteroids, treatment in trial an provide axatilimab. offer commercial differentiated agent of occurs, with additional a differentiator before care could commercial comprehensive for significant successful trials and our combination is and the an to entrants, a in unique Newer than activation had opportunity as the substantial unmet are action to key supports damage in a mechanism minimal benefit axatilimab fibrosis of Incyte-led the decades. axatilimab to II moving potentially also partner indications to [ the ] review treatment to one antibody, interactions of expected currently

Keith Goldan

Michael. you, Thank

XX. Turning to Slide

XXXX.Turning fourth $XX.X general line the research and the were quarter $XX.X in strong the and investors. expense, Operating $XXX million, runway well million, cash million earlier, administrative with $XX.X expense adding income providing expected is sheet strengthened quarter, high-quality from validation on in potential new mentioned year-end Michael as at balance balance As as of for $XXX comprised The fourth through of guidance. expenses selling, to sheet, to million million we both of provide statement. our of and the existing Syndax's institutional development

Looking exceptional advancing approach always mind achieving to XXXX. our and financial and full forward, enables embraced first disciplined launch pipeline this and axatilimab year we've execution strength the resource us guidance a that for our of on of year.Keeping in an the revumenib to quarter focus provide to financial like I'd later allocation.

total the $XX million expects the $XX million $XX to first and and to million. quarter, development company expenses $XX be to be research to expense For million operating

$XXX million, million of to $XXX full and call $XXX company the $XXX including million be expects that, research approximately the be $XX to to expenses let now the For me noncash compensation over back and to XXXX, million million Michael. year total development turn to stock expense.With expenses operating

Michael Metzger

Thank Keith. you,

have XXXX during a landmark the call, growth you and was for As execution. heard year

pivotal this our what's evidenced X candidates, come to submissions and of and of are drug Syndax. both As readouts for potentially lead which X best-in-class for first is the by treatments, regulatory positive our trial beginning only

team We in beyond company initial significant indications, high a opportunities are potential a serving confident that that and long-term to biopharmaceutical milestones multiple of that are execute I'm on set growth on laid in for out right potential.We need. broad their to programs fully Syndax's we patient integrated have the out adding I've have into them. the registration offer ambitious plan transition Slide for and Both populations goals XX. XXXX, unmet place franchise and

your building long-term vision with like sites express cancer. programs. for of like to the investors closer questions. thank involved and with patients, Syndax Operator? share clinical team, work, improving As our mission I'd to getting I'd who most trial of and lives to my also continue collaborators important us the delivering our to open Syndax.With the appreciation committed importantly, investigators our in like that, Through support in to call on we patients our the always, are and I'd sincere

Operator

from [Operator Lawson Peter comes question Instructions] Our first Barclays. with

Unknown Analyst

potentially Shay [ for all to progress. [ your related you sales is Difficulty]. still dependent Menin axatilimab, This for ] Congrats is that, Peter. ] are [Technical on that on expectations XQ? on in the launch for that you're XQ announced potentially for like be you potential comment this expecting approval on And can sounds PDUFA for XQ? expecting it Or inhibitor, the a positioned in to

Michael Metzger

the second on bit question? take you little question. a up broke want Do you think to I off, the first first So

Keith Goldan

Sure. Keith. This is

actually third have the still FDA axatilimab when question. drug for is we PDUFA, the a the quarter, approves So

earlier, year, we've the into out as said in the earlier co-promotion co-promotion of and axatilimab. As laid Michael opted the we've

approval So to we'll force be either our of ready product. prior with the sales

looking at recruiting looking website you in Career the of section, currently the managers. can LinkedIn see as our we're at or by So all for territory

that's So public knowledge.

we'll the prior of think to the I of from we received answer PDUFA a respect approval better time, that of And We'll agency. revenue. initiation revenues. we'll to when until have the questions? date idea them the and up revumenib on at that to So timing this your Does around have action to of the later expect when have PDUFA date, product.With your revumenib initiation quarter trained question wait of board either

Operator

Rama Anupam comes Our JPMorgan. next question with from

Anupam Rama

just Maybe expanding on comments now. key

just maybe as think the Just term? the And your remind quarter-over-quarter launches. us growth about here your of in force, where What we plans XXXX, to then kind are some we sales terms you line are of SG&A think out. of the in expenses, the near -- looking team especially sales about on on build here pre-commercial the how of

Michael Metzger

Maybe I'll Keith force the take part first the to out, of answer. sales leave build terms I'll rest to in then and

remarks, we've targeted It's as revumenib, launch now I we're to think to for axatilimab overlapping our co-promote both past, overlapping, in opted highly the of an that organization out as my to into accommodate FTEs I around So commercial said with provide call Incyte said building the but the XX% point. up and of the we've in effort.

cover the also products. cover is so and here roughly the with XX And quite extensively to both U.S. representatives to opportunity XX

-- on agents, PDUFA the approval that's we mentioned, for axatilimab, until will both have until well. have which, the time revumenib and as up imminently we that a PDUFA as of at continue right Keith force for expect of end of So sales the build-out we August the

extensive well So leadership work been in -- do is sales want doing ready.Maybe, get of handle has we'll of to in those we have Keith, point? second hired both force you the advance to the to put be and place ready and

Keith Goldan

Yes.

question we million. R&D, OpEx $XXX gave for $XXX stock your for noncash on respect with million guidance million comp. on the to And Anupam, $XXX SG&A $XXX million, then that So today the to expense, includes to total year,

for total reps, was about million -- that, SG&A -- the totaling we fourth you can and the can circa assume slightly year, the in XXX [ So higher Last based about year $XX the on million that $XX SG&A the ] quarter.So it's is year. you of ended in in recruiting think I we're now.

reasonable first take of of add pretty year growth rep reasonable of math the that year field SG&A we HR, the place on year in guidance the assume on. And for this second board half finance, it G&A to given total per of both cost place. I a and think fact the that the $XXX next can given half OpEx simply launches second $XX out well in year. per as will advance well.But And that quarter yes, million million, would the year you the from million a have they're infrastructure expense year of definitely, R&D in kind and from infrastructure is we've think work of the commercial of addition be force, be for $XX definitely to the the I assumption IT,

it's plus with [ that. the reps to go A&P be going to the So ]

Operator

with TD The from of next Cowen. the Phil line question is Nadeau

Philip Nadeau

follow-up on axatilimab. the Congrats on and A on a progress. the ASH couple data then

data, And So on in that terms thoughts get those. are to there keep curious investors? we the X controversial ASH aspects debating with of your

said toxicity regimen, you to was background AML, everyone that revumenib agrees. know additive there First, I in not by adding SAVE the no

of that SIP Phase rates light there's second, what in determine neutropenia And again, BEAT-AML, How address the do dose enhanced is think you on you XX% dose forward of dose ]. found? some interaction anticipate ASTXXXX So alone?And the Phase concerns ASH? BEAT-AML? going that you II would would revumenib ability, particularly you the once through dose that [ expect? II will combined about What have then would the could the you type adjustments I at of showed

Michael Metzger

Neil, up going I'm wrote and to you it think then make he can about over so turn to address I BEAT-AML. a SAVE, the comment question he'll about first

Neil Gallagher

Yes.

population. first SAVE pretreated accrued thing think the -- I very a remember So to that heavily trial is the trial the

of I've been been -- half of [ over -- half or failed heard X/X have van of them prior transplanted. patients So had have ]

of there's rate would what not around with backbone.In I a the -- of why prior And therapies in look comparison. I cytopenia trial. is is So Like not population you selection, the from to not observed X rate was the sure patient to valid that's therefore, this the And heavily have entirely I'm [ others in according think been a at some investigators [ population maybe population. ] that with patient comparison study, that population consistent X. that can investigator that that people's we them if a confidence the that pretreated and minds, patient his of there's would stated cytopenia has to you decitabine median but of less a that number that's be why what consistent just both. expect -- understand was expected Zen particular the I included you the investigators ] oral only terms was we understand and the in therefore, and BEAT-AML, agree dose the challenge mean that to with in with

doses [ right? tested the independently trials for So event reported presented combination our was of X BEAT-AML as the the there at revumenib audience, at at investor were also that event ASH all reported just of Or of to out itself well. reiterate we X was entire ] in ASH,

a RPXD doses, Those year.So trial intention X refine And is by twice SAVE, relapsed a just it pretreated X all patient final just the publicly trial. of XXX doses in in and newly XXX our milligrams trials, proceed would that all one what both combination group III we point. -- we've for be trials to the in further XXX end and BEAT-AML with just -- they Phase Phase to strong that milligrams So and a included and day obviously, were XXX stated discussed, windows twice to many populations, okay? So the cleared, is were XXX were they azacytidine what was milligrams CYPXAX inhibitor, that milligrams day. toxicity the times monotherapy is diagnosed. X in that at And the doing dose-limiting heavily were you were the BEAT-AML Different presumptive -- AUGMENT-XXX, in is dose. full And for to cohorts were now expanding refractory. full dose -- the okay? XXX Also, recall have to administered doses is BEAT-AML, pretreated the in highly administered venetoclax relapsed/refractory X the that respect active. trial with and those when heavily also III patients.And a

-- newly setting as no our the as ] with ven/aza the X the there's well [ in in mind So that in revumenib -- other there's question settings, it's diagnosed of the clear. combinability

Philip Nadeau

marketing. it clear. then on last just That question very is Makes helpful. axatilimab and And sales

think for prepared XX% is efforts in marketing I answer. said responsible you Syndax in your remarks, of the the

are physicians there well, FTEs. -- [ marketing said with FTEs? was other defined? else? as co-points of or something XX% efforts marketing Or XX% specifically such ] XX% think Anupam's that as are to or touch to the efforts metrics question, how of deliver points Syndax Is you of How needs I that

Michael Metzger

Yes. Keith. Go I'll turn to over it ahead.

Keith Goldan

Yes.

if So clear. weren't apologies we clear, if I wasn't

of with XX% the so contribute -- have the ability the stipulates Incyte we our effort. So partnership to agreement promotional

be a that So point XX% we'll call perspective, from delivering sales effort. of

advertising in that their But because their And split would called to the P&L up. sales forget, cost product incurred XX% the the mentioned into P&L. I cost expenses Incyte joint XX% P&L bottom combined like lead So that FTEs XX% pick our joint any right? number commercial before and combined a speak promotion of of force Incyte, of taking put perspective, it the but because put that joint of into is that effort the we of So the of from effort. [indiscernible] we'll that by in delivering XX% want they reps, will be into go I it's didn't XX-XX. the profitability the -- will -- effort don't are P&L, P&L. then that they the of

Operator

next Our with Stifel. comes from question Canino Brad

Bradley Canino

are patients you year, of and available launch they're relapsed/refractory provided peak of of concentrated KMTXA but expect out this things setting, that in what in You've number the terms the sales opportunities, see pace do to where for playing the uptake? how

Michael Metzger

guided get a projection, and give to we'll little ramp the to a closer and bit because maybe early speculating commercialization. I think we little to sales about reserve more ability start

the I think a the say, KMTXA opportunity a a first-to-market, trial. we'll really, is commercially we earlier as patients tested think we stated clinical in -- have they compelling than to address in that I'd our even remarks, were product it's sense in best-in-class

in relapsed/refractory setting. the hopefully, talking dire on these that overall, in of revumenib majority can patients.And X,XXX of that of discussions we're Many in vast with need believe of back are setting. We and treated pointed patients which treatment go through to the probably transplant, we've use in potentially address them of patients as the therapy. opportunity are So X,XXX treatment a those the out about have post-transplant previous to then we'll

there we use drug. the Physicians population. a addressable quite to highly think, So seem is, to be motivated

also And that heard from we've in trials, our we've so physicians. but seen that

of to a very this launch. really get a the in to So opportunity a I to interesting -- the point at drug no for sets current think successful as at come market current point competition this up really new way with

-- see ramp, we'll in preserve terms how projections that and discussion. we we where launch that's and of future for it a maybe So today

Operator

Our the next Schmidt question comes Michael from with line of Guggenheim.

Michael Schmidt

one to data revumenib for inhibitors opinion, the in I the frontline with rates, given other is including other right combination are X+X. And your status, menin setting in view on presumably opinion? What CR and X+X important had own already. or specifically, that X+X? study, high any your that MRD for with in measures what rates looking first-line for way example, In top transplant would that very one efficacy benchmarks are on of you're combo expect your

Michael Metzger

get to a certainly handle one, Important on.

to NPMX know, treatment. XX% those as is upwards you I think patients frontline the respond respond and X+X effective KMTXA in patients highly regimen, the, of of patients initially

for long. don't usually respond they However,

that CR/CRh, most relapse would just with which looking patients. both seen for transplant of a course, we relapsed/refractory happens rates MRD look to obviously, we've there's CR in rates, of high those be So be for and rates, of beyond -- patients.Things would

to and you'd of Now we're settings. certainly be frontline MRD transplant better moving moving to expect to and rates earlier -- see in line would equal or

of period the course, remission -- some ability course, in patients X+X obviously important you the want treatment, that's time so those are haven't measures, and is an to And We with front treat X+X see.Of that line, I revumenib as the short haven't we'd inhibitor for menin something to course, new a a really is in of of seen it's yet. right? -- keep duration of days, extended think perform

relatively see see you of to clean you'd profile need a a on up But be to to us and highly but responses perspective, kind So of looks add it you and what deep the want well.Neil, I to want would you certainly, think there. and CR know like what anything? you for from the to effective, kind continue durable a bar as set trend perspective, safety do

Neil Gallagher

think And about that. may be. potential could Yes, a things that. certainly have to what to endpoint question I It's I X talk would too about soon context maybe add the just regulatory the to there been

maintenance and point you of our would think included will, conducted last interest, make move closer I far or look that to closer our that approvable phases. as on seen And be a to III we time recall CRs as that going for trial the course, been we the would the of that therapy really we you have seen, discussions has be, could negative what also MRD years X+X only trials other conduct patients is towards we XX we've that, would engaging in an mentioned over medicine any of XX Phase maintenance diagnosed and the as now initiating of we end [indiscernible] would monotherapy assume anticipate an the would setting with back would add be Michael post-transplant X+X in periods newly as endpoint the molecule And of speaking sort at ]. to be trial would have relapsed/refractory trial.And whether having I then dose-ranging to remains be, could not who've in as if And certainly of it move support protracted therefore, remained to is the in setting, initiated that agency the well seen, that tolerability phase. that setting. consolidation maintenance for include the [ probably the instance, a move well, who of most we we very given revumenib that -- tolerate therapy likely patients as relapsed/refractory after induction what

Operator

question comes Citi. Nochomovitz with next Our from Yigal

Ashiq Mubarack

regulatory leading congrats few How PDUFA guess, be to on is first, out. the Mubarack that? will of are Obviously, weigh had Ashiq a process is review? the I I we how part on think Will from involved on the I'm for just point we date. you this be in know you about mid-cycle label proceedings, the This but wondering able in on inside we Yigal. should negotiations? axatilimab.

Michael Metzger

very -- axatilimab, the Incyte. with we we're with Look, with it's and been collaboration a close data, obviously, generated very involved

so to we involved them with And and approved are working facets. are the get in regulatory closely all process this drug in

label So like and things negotiations you're thinking about that.

are, I'd very say, with say, on. involved suffice what's going We to

to And for So we great that's think we company. the and with an obviously, the exciting experience want have that involved. we're development molecule,

-- certainly of is.Was there it? that that's what part Or your second did was So -- that question? cover another it

Ashiq Mubarack

kg this the evaluating on another prior that per AGAVE-XXX. wanted don't you're which one ] but No, we just ask remember or from looked know clear. I X.X I best IPF. mg very -- I to forgetting calls, dose, Maybe dose obviously was I'm that's simply, the in [ just

confidence specifically to what felt dose right that's confident enough that And is dealing it the you we're optimization I enough disease biology didn't Or a of different do similar with IPF? Just end work? you dose that. why for wondering here. do to you need kind guess gives not really point obviously,

just So your are. curious what thoughts

Neil Gallagher

I'll Neil. it's question. the take Yes,

a a the it's selection. We did discussion long no, dose have good internally about question. So

was to of robust X.X superior over would X an time X.X to to sort trial in us in in trial was for of It's other balance year get doses. and of -- announced execute milligrams. AGAVE particularly need felt everything talked which couple the And Quite that that don't the of details AGAVE was of design in today. trial that the we answer the about terms one as also a clearly as we've -- And proof-of-concept the that clearly, that. the IPF efficiently of of the with sort the So well past things. in terms efficient go looking dose on but the be therefore, milligram the design. X the of trial, the about the tolerability.And should efficiently, we described of we dose were over we design, today talked a what have And proof-of-concept quite back the trial meaning trial, a trial efficient it superior this before in most times number that efficacy we balance to reasonable to that the ahead and was dose of go we

made that that decision, to of yes, is decision. sufficient partly and you that alluded I a one overlap I have think there that to to from point that think sort led biological perspective to, us

Michael Metzger

the volunteers. We we I'd behaves. Maybe at the add the know to ranging also at the probably We've Phase extend healthy how pivotal on, looked trial. on in you that well looked as early this did we that, as of antibody course know I dose

And so -- on has effect and macrophage. the that the it

to dose to think appropriate in therefore, here so has kind added. us some, of good the confidence I translate in X.X Neil IPF patients and would be we the addition would it gave think, I some the what understanding pharmacology think And how that

Operator

of from Bank the Our next line question from Zemansky Jason comes of America.

Alexandria Hammond

Appreciating tumor-agnostic expect it's label? submission what color a for and in included [ PAL for CS not your Are but with base regular the some with revumenib, potential the patients ] [ you X your provide ] safety you evaluable requirements This XX.X% efficacy on can QTc is And AML [ on prolongation. Alex on warrant a early, CR/CRh Jason. monitoring somewhat ] expectations to label? and Hammond what regards be are to for

Michael Metzger

kind then and to Maybe Neil. any label, it maybe talk over talk He about bit little the safety. a of I'll about turn

Neil Gallagher

that in XXXX let say me about the Sure. Well, we mean, kids. I December label appreciate everyone for BTD what that is -- to AML [indiscernible] our got a and adults anticipation back by reminding ALL and to I'm

premise broad around them, that So forward The development Phase those from moving potential on moving the based have from would the data. a development I indication. we that there based forward a for program program was

submission as Cohorts that pediatric on that As which, and Xa to includes you know, adults well patients. pulled based course, we and actually Xb, AML, of relapse ALL analysis, keep leukemia the is for KMTXA pooled as

of and our coming course, for of whole So way, been journey and us that onwards. with -- on BTD, has is sort the including anticipation agency the from fully -- through it's BTD, BTD

for. that's looking So that we're indication the

do of is that of So our but not your happen differentiation that's QX and -- We syndrome anticipate knows doesn't target. a that. question on not words, leukemias -- that's therapies we the it. since but for class from [indiscernible] exact rearranged happens, it acute AML, these don't KMTXA in agents It a ], perspective, to about broad in first all, second right? so children.With agency anticipate anticipate typical -- [ class, a we would precaution warning the class It's so we targeted adults in probably safety monitoring. anticipate We respect meaning of

Operator

with Our B. next Riley. question from Kalpit Patel comes

Kalpit Patel

Maybe study? as the the they're be is, fit? about question KMTXAr should on revumenib on you're a the enrollment color think that XX-XX Can of Would split are KMTXA you a split? to and NPMX the with?And the anticipating second X+X combo planning the how what us study. between start Or we of the more you in give goes it couple then population combo some skewing patients

Michael Metzger

to question, Yes. the first take and I'll second I'll Neil. Maybe the give Yes. one

that's think So just -- you think I I it. said

or -- KMTXA more have the patients KMTXA not where unfit, -- think skewing we want So we In NPMX, fit both.And I X+X in skew, this you starting of the terms they dose? of don't population patients right? do know. of not, we are about combo, representation overall it's or whether but to don't that's we really do than the KMTXA expect versus at a talk know point, our to Neil, But

Neil Gallagher

Yes.

the X+X. add between really mean, we matter that So CYPXAX patients XXX right? It tested, -- as and What instance, split actually NPMX first the be doses therapy. and X+X the on. that without and CYPXAX, the earlier KMTXA also we is made seeking that to doses the are thing and know demonstrate doesn't we that to know trial we're just based that X in have one well.I we've described revumenib venetoclax-based earlier And call the of combinable all combined will And is far, the those a combination we strong doses and we thus mentioned on they're as testing in -- comments that on the equivalent milligrams. data trials chemotherapy presented XXX ability little both milligrams bit the in with that the HMA on we've there or been before,

Operator

next question the of Our Zelin from comes BTIG. with line Justin

Jeet Mukherjee

patients, you looking is perspective? best for just what axatilimab provide opportunity of perhaps for IPF, hoping efficacy therapy subset of This Jeet for could a suited on from the Mukherjee the should sense little a Maybe Justin. of axatilimab, coming back and bit an in to was for be I this

Michael Metzger

Yes. you want I don't that question? to know take if do Anjali,

Anjali Ganguli

and actually start. can I I Neil both as sometimes [ of there's this on saying lot the bit added the expectations. one them large And in to are sure. cycle marketplace. that very do SEC a on There need need decline. another. huge still and really the there and unmet though see in so the U.S. mentioned the we're -- a All there doing we standard Keith, of even will preface a the is add data treating out of little that, patients they They're in be to expect call, to patients today But is drugs through by more the on we them Yes, care. disease, I know able we and approved, X number not IPF are ] a trial of slow to think alone, hone that to to would

would a significant the large get population at And or need. expect, uptake looking think line we in positive of that I So utilization. based because be we'd unmet second to on data third

Jeet Mukherjee

And helpful. maybe on one axatilimab. just That's it. Got more

looking Just forward what efficacy the and both doing be with there any and on ruxolitinib Incyte. steroids studies perspective one combo And collaboration ultimately? from additional you'd to an color or you're just those with in safety move or of perspective

Michael Metzger

there? you to Yes, Anjali, follow want do on

Anjali Ganguli

sure. Yes,

So we're helping bear of on again, disease axatilimab the bringing strong disease courses organs to what therapy. effect therefore, that change this fibrotic is trying hopefully the with potentially to on patients to and manage the shifting the impact combination of and

thing trial the this their So I a Right impact moving We earlier, really have us govern overall they're think would some of getting patients this those unfortunately, out in the up disease that physicians have forward. would data you what really is But coming looking years. they telling bigger like. uptake and profile are could really for. only they now, much good. do and do steroids anticipate harm And as is the something going on as look that

know And if bring about the earlier could prevalent steroids combination, axatilimab estimated patients. to an use and the you up population. mean XX,XXX that minimize out efficacy current we is strong get you I of of so pool could

good with And chunk that data. so you of could access big population a

Operator

with Farmer Our comes from next question Scotia Bank. George

Unknown Analyst

Kelly [ George. us ] revumenib. is Two on for from This on

FDA AML approval revumenib? secondly, hold for sense to ALL? intending for have do any KMTXAr other the the whether to speak or discuss could prospects on the package to in meeting you is So an And you indications ODAC

Michael Metzger

Great.

of to So an indicate more for we in than showcase that reason. will any we word the would that for ODAC. expect time have any do an a they for From hold as to and from they don't that FDA ODAC, received other expect time FDA don't we terms But the haven't mechanisms, do new an we ODAC revumenib.

whether a axatilimab there disease, disease So remarks, going a is presume the how sufficient beta-catenin data activity revumenib first my cancers, cancer I types, at And additional very sorry, pursuing, some get previous you that's phenomenon broadly of for which looking colorectal colorectal leukemia. tumor we're a obviously answer are the I and year think monotherapy as one. this metastatic had in state, secondly, to quarter agent lot prospects a performs.There agent, your a have asked of in there's through different to colorectal thesis the as is monotherapy first and outside in or of then question.And that cancer upregulated difficult that to about we indications. drug means as I at is second we're this mentioned implicated it's third-line

other could see treatment. look And whether be so to cancers we susceptible revumenib there to that they're

tuned. be There So stay come. may to more

here that I trial certainly the first step the we're colorectal running. is cancer think

Operator

Metzger comments session. Mr. additional question-and-answer I now any floor concludes the turn for over or will closing to our This Michael remarks.

Michael Metzger

appreciate tuning at pleasant our we to with and We including Thank Healthcare Conferences you you seeing in planned And March. upcoming you very forward a the wish all. all and I tonight, investor evening. Barclays you that, look in Thank events, Cowen you.

Operator

concludes This now call. conference may today's and disconnect. Thank you you,

Syndax Pharmaceuticals (SNDX) 27 Feb 242023 Q4 Earnings call transcript