SNDX - Earnings call transcript Q2 2024 | Syndax Pharmaceuticals, Inc.

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Operator

Good day, everyone, and welcome to the Syndax Second Quarter 2024 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

Thank you, operator. Welcome, and thank you, all, for joining us today for a review of Syndax's second quarter 2024 financial and operating results. Dr. with company's afternoon results progress Metzger, Executive and update provide are: Klahre, Chief the on and Officer; Sharon me to this an Michael I'm discuss financial Steve Neil Closter, Goldan, Gallagher, Financial Officer. Head President of Chief Chief Officer; and and Commercial Keith R&D; us joining are call on for the the Also session question-and-answer today Dr. Officer; Scientific and Chief Ordentlich, Peter Dr. Anjali deck of posted been Investor page that the Business website. on call accompanied is Officer. This Chief has Ganguli, by slide company's a the

X. to our forward-looking You can Slide on now turn statements

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

Michael Metzger

shortly, Syndax data and upcoming exciting for joining the Starting with becoming with approvals X today. year us Slide FDA of commercial we have several Sharon. you, for the stage June, Hematology support is and strategic afternoon, pleased company of Good a This you the milestones Thank revumenib first-in-class a European stand AUGMENT-XXX anticipated with cusp to very thank clinical everyone, combination X. axatilimab, on as updated diseases from high In need. second for unmet the BEAT quarter report and that the trial presented priorities. AML revumenib I'm at we Association achieved positive treatments that data had we were additional our review in medical in with axatilimab set and latest that potential GVHD. all continues in that standard previous will data symptoms, fibrosis pivotal agents. At presented evaluating AGAVE-XXX Neil organs refractory enhance current shared, the noted which care clinician data, patient in skin. this of activity, These of had in supported graft-versus-host positive that such to revumenib's joints from responses to reported improvements we organ-specific dominant organ shows the pain breath, patients chronic data Reinforcing as also Congress. response reported and or disease swallowing, EHA shortness or in trial support changes by sclerotic clinical we EHA,

XXXX, information a NDA to to extension time full PDUFA December X-month additional acute a recently approval anticipate track coming of Looking As refractory XXXX, to antibody this for revumenib, September ahead, anticipated FDA revumenib to for for action we patients inhibitor FDA leukemia, year of our soon. With response for of with the of conduct August review request. XXXX, revumenib PDUFA the have year their from patients FDA GVHD, XX, allow insight axatilimab our standard supplemental a provided XX a we the partner [ we in are axatilimab, fourth this announced with on XX, our and menin December earlier of we XX, historic extended chronic being by quarter action date we a or anti-CSFX for date with in with have date KMTXA-rearranged launching the ]. week, With relapsed PDUFA reviewed and action

continuing soon We to the these with review X information confident that look as launch we the have and closely under their to provided approval or the are the for forward engage they FDA color program Real-Time to and anticipated Review benefit complete to preparation continues to to Later call, our ] as brings Steve anticipated approval. stand ready revumenib additional provide as support we we will demonstrate on RTOR, the with meaningful some patients. Importantly, receive strength launches. we Oncology revumenib in [ the

meaningful revumenib approaching have XXXX. the also quarter, NDA of as half readout which other the such in a relapsed/refractory for as fourth several in AML top pivotal data could the basis anticipated the milestones We filing in first serve NPMX line of supplemental

in and expect and make results their support months. Positive of trials expand a that of in advancing care planned use revumenib Additionally, thereby medicines to with progress in to underway these of axatilimab significantly. future our treatment could patient's standard clinical earlier the initiate we the or are agents combination further coming utilities

in expect will a June we position XXXX. through $XXX in that million are strong of provide with XXth financial as We capital sufficient cash

Our pipeline. to and some current beyond data of only launches recent not supports balance sets review our our business Neil and first expand early indications clinical presentations and pursue commercial Neil? but also to registration ask us development opportunities. I'll trials, sheet now to planned our up stage

Neil Gallagher

Thanks, Michael.

Turning to in X Slide revumenib.

a robust will the ] or strategy combination ] use refractory revumenib [ maintenance that frontline post-transplant initial [ clinical and the relapsed support the care in relapsed indication ] revumenib trials [ ] potentially leukemia NPMX [ standards The use refractory in with in rearranged of [ with acute of support extends have of We treatment ]. the beyond with underway mutant across development paradigm. KMTXA in or that revumenib development plan

] no diagnosed and the BEAT Lymphoma presented EHA response or that ] [ next negative. the slides, with X updated NPMX azacitidine briefly the trial data of data the trials in the recently patients, and On therefore in cutoff disease at EHA combination presented mutant ] May with updated I delisted, [ of in with of XXXX, venetoclax the XX% rearranged and Slide KMTXA were of MRD from with and patients AML CRC we X, patients evaluable Xst BEAT from with ] XX revumenib ven/aza newly X This at the of On or AML. or Society and combination composite efficacy AUGMENT-XXX. will the we Leukemia XX% data sets AML [ complete review [ and collaborators June, residual

The As in X every investigated, this or each administered far, all are are order the being with historical reported XXX consistent has for were is and currently hours. ven/aza ven/aza revumenib of [ milligrams limiting carried trial, doses combination reported. Of the dose identify DLT associated EHA milligrams note, events trials profile window being tolerated Phase ] and combination The safety controls. the what to revumenib last toxicity for both of the on [ development. been the conducted XX with and from dose are expanded combination of consistent data at is with adverse in rates so cohorts III XXX well study observed year ] in previously the

the ven/aza the [ addition revumenib does alone. example, modest of doublet not associated ] with exacerbate For appear to to depression the

investigators development. Additionally, dose strategy suggests the the ] the that revumenib adjusting the data may venetoclax [ AML of for be maintaining while BEAT that computed methodological future the doze for

communicated, year-end. we've with scripted trial newly previously we diagnosed patients pivotal initiate intend a by to As the in combination

mutant rearranged population to combination to NUPXX of or the X. in data predominantly cytarabine refractory with from presented pediatric [ relapsed fludarabine in with or ] updated Turning we also AML. KMTXA-rearranged NPMX, FLA or At and revumenib AUGMENT-XXX a trial Slide EHA,

were [ with patients Furthermore, XXX patients prior data FLA of median received CRC As pretreated milligrams. Patients XXX certain ] rate XX% entry milligram negative of the of or FLA-containing patients of [ trial in XX% the XXXX, with of lines transplant CRC. XX%. revumenib January had among prior remission ], heavily regimen or X included cutoff XX of XXth of at responders composite a therapy, to of complete or achieved patients proceeded The they permission. MRD once XX% of

support to the of just tolerability care updated relapsed [indiscernible]. ven/aza profile diagnose different refractory not standards of does that These combining with care for the EHA revumenib appear data further the sets as discussed alter regimen. well standard of As revumenib provide in with -- presented as or newly X triplet, we the further

X. of NPMX pediatric the trial pivotal Slide refractory relapsed also completed AML we cohort adults the and XX In the in March, mutant to enrollment or XX enrollment of patients. AUGMENT-XXX with Turning

We are leukemia our track patients. -- on acute

We patients a XX see rates with results are AUGMENT-XXX, remission of all quarter. On X or portion XX% of in what an transplant portfolio on therapy recovery. the this well the has track negative. a and slide, mutant despite XX% to -- And CR KMTXA tolerated remission NPMX cell Phase CRC that partial response NPMX fourth from from patients enabled achieved the prior KMTXA-rearranged [indiscernible] revumenib proceed Notably, report durable the with response the that in indicate data patients showed the to in venetoclax complete population. transplant. These many mutant were which revumenib hematological you with MRD consistent patients can achieved with having data safety is that with to the with also a is with reported overall been consistent population, previously also patients in in of patients

hand like robust preparations engagement medical I support generation. driving to highly Steve, on upcoming over the launches. of a affairs made Before quick team that We've built to the overview the scientific we've organization provide X side to a medical the evidence Slide of deep and I'd and is anticipated experienced

X our and the Nature, from to and papers awareness participation journals of in publication EHA have conference top-tier underway seen you've from an plan agents. and data as As various ambitious well ASH as our such we increase as compelling

revumenib for as we top KMTXA. the continue revumenib potential it's presentation. We will note, that NPMX information feasible of prescribing the as once include prepare data approval to plan guideline soon we Of anticipate publications submissions are in mutant well and AML NCCN inclusion to as to available, support the as publish peer-review guideline and congress following also for line

Additionally, tremendous centers field. of made science a excellence positions major medical across of They've the a liaisons scientific we driving in country. team the seasoned progress exchange, which have

patient the over groups. With built economics increase team the to we plans portfolio, a our value our opportunities. also and launch continue evidence real-world I'll Steve? on now engagement to it about of Steve market turn commercial with supporting We health that, advocacy focused talk and to and

Steven Closter

everyone and joining a pleasure about really as serving position to to It's care Neil, Syndax you health talk leading thanks patients commercial be and providers. you, to it. making Thank extensive today. to We for preparations the us really with stage we're appreciate organization a

execute prepared front well exciting opportunities us. of to are the We in on

Turning to Slide in X. revumenib preparations

hit upon trained field and involved in soon team we the us is sales space the and their and in simply anticipated anticipated revumenib This in We've with care. This track hired the understanding [ running needs we now pre-existing the strong launch, to success. ready and ] needs as relationships demonstrated goal let will can as extensive Our ground FDA. oncology record is approval are treatment experience different from pre-launch receive hematology, we the robust with a journey patient the a for and stakeholders begin right approval. meet team so filing the of accounts meeting of rapidly patient preparation a

in years the that centers those customer-facing needs of KMTXAr we XXX on Our more team in with plan treatment. patients. XX primarily we of an average product call relevant believe X receive patients an With individuals, meet of an or believe roughly XX X/X X,XXX relapsed/refractory and to potential We we XX our effectively the more of of has should footprint and physicians approximately efficient concentrated plan, opportunity, reach effort. than and community-based of accounts average enabling force of we academic hematology, oncology With a launches reach centers representing field XX% range the centers with of can to each. the experience, and

options, is that data these identification indicate our Now that engagement appropriately develop mining require capabilities in there appropriate identify rapid patients. done very of capabilities based developed patients another where important on targeted launch high-risk will tools for to we've preparation Because to the are are help initiate treatment us patients thing need. the we've advanced physician

approval, plan, with built team exchange team and Together XX% new information with covering we've our the to continues on respect provides. Part all and to we'll expedite to with commercial recognize payers XX plans products. B lives track We experience payers, pre-approval payer within formulary working facilitate extensive review ] when to prior to with trade of believe access, unmet market more X access the and their approval. Payers covered and [ us decisions months revumenib them that appreciate make medical field their of to with other we're reach the need Now anticipated to tell that work with possible. partners than an will work the both they team, accomplished affairs and the value

new and [ patients the exception pharmacies launch recognized given pharmacies leading a patients of that after prepared to support needs, approval. specialty oncology also Importantly, ability medicines. Through support we've expect a level medical support and very program for best-in-class oncology dedicated from we're help patients patient on you the to channel provide to plans will launch navigate what are ] access distributors, their quickly urgent access right providers to with a to have and par that network we partnered of and will providers specialty specialty the ready process product through to leading receive provide who see product company. well We're patient we at with,

transplant estimate We to or patients. [ approximately Turning IDH to FLTX months, the prescribe the continuing of with patients market eligible acute median population We for and targeted approved eagerness to KMTXAr revumenib an duration market ] majority engraftment. or represent such therapies $XXX are pricing these opportunity leukemia, X to XX% leukemia an inhibitors. Physicians of revumenib no in relapsed approximately leukemia or patients, believe AML, U.S. during Slide and and X,XXX other therapy all following incidence refractory X,XXX The acute we've about treatment the relapsed bring supports of of in about monotherapy more journey disease. alone FDA There X totable targeted in represents clinical by treated a KMTXAr AML ] opportunity. patients early spoken transplant across the responses indicate annual experiencing competitively data acute to with then NPMX million this to up therapies believe of refractory extend as population. the a [ of KMTXAr addressable we with patients

first brand. success physicians will revumenib long-term our with early advantage We treating gain be of vitally that and expect mover for the experience patients will the our important

in share to the market first likely NPMX extend that the market data to KMTXAr, as such AML. significant estimate other meaningful Our pivotal X deliver especially indications, will meaningfully X,XXX beyond segments billion in be we We of is in distinct [ U.S. in and population opportunity X,XXX and ] leukemias, combined the acute refractory setting accessible $X relapsed or to NPMX KMTXAr market addressable approaches equal a an patients the as that

seen and advisory patients. the revumenib delivering various experience commitment to an had more, meetings for the building health in During absolute clinicians, I I've and that with I've care tremendous business a to and look creating participate boards field chance best-in-class to for that on excitement forward from to, momentum our support to providers

EHA points. Paved raise the the carry anticipate AGAVE-XXX is that with with way we Incyte the detailed launch, in continuing X for commercialization be at GVHD successful site established long-standing that distinct team the Moving own to effort, recently the axatilimab Incyte of led highly Congress. through we their of overlapping benefit from and trial, sales of outcomes we'll drive with XXXX by payers XX% will observed on call will products the Slide the building field the XX. experience our The and axatilimab Jakafi. We'll anticipated awareness engagement and targets which to a deep axatilimab leveraging and provide pathway compelling market they've relationship force work, the that

XX. are an for at We time, are majority progresses. disease opportunity. control after any XX,XXX Turning Slide there for our which our indication for lines treatment be previous and of and therapies cycle the one X,XXX chronic approximately progressing target represents refractory are approximately estimate as symptom to through attractive of first there better GVHD patients treatment, on X whom to believe lines their patients would population later of treatment initial We

to remain in the the grow, billion line patients months nearly sales the at line $X.X assumes market will on total between a the third of based and $XXX on they're addressable profile third for and billion, priced is million. We assuming since and chronic therapy $X agents axatilimab is estimate which its for drug indication, B Part reimbursement. approved and XX to that net Rezurock For X for treatment that continue instance, in launch to other years with at product over premium GVHD, U.S. a annualizing

such setting, third anti-inflammatory the diseases earlier which we to settings IPF, represents in chronic for as opportunity. I'll Keith to line review GVHD believe financial line other our is study and to it's now relevant, the a we axatilimab call Beyond over turn results. mechanism and anti-fibrotic plan large where

Keith Goldan

Steve. you, thank And

Slide to XX. Turning

the As of long-term cash investments to our $XXX provide balance on earlier, we runway June and sheet and million Michael mentioned through equivalents XXXX. short in expected XX, as

Our financial of strength commercialization allows of and realize us to to invest the appropriately continue fund anticipated pipeline. to X value drugs our the

$XX.X expense. million in $XX.X million included research the general second to the statement. administrative income and development expenses of and and of $XX.X were Operating expense Turning million and selling, quarter

year guidance financial quarter provide me for XXXX. the third full and Let

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

is and year to the research to expenses to expense full for development I for product. to and that includes be milestones and to guidance that review stock or full for $XXX expenses ] the revenue margin there $XXX launch to expense guidance. to sales and recognize operating and research any range how year that we to example of between provide is any potential provides be partner total development guidance, existing note expenses XXXX, intended includes Slide $XX of briefly an the the noncash $XXX any will our and the no other approvals. Ahead [ illustrative expects drug owed For of XX of partners axatilimab, million want guidance of upcoming axatilimab of on million. Please company change accounting not compensation the estimated for million million an operating $XXX million

expenses. We will of product and profit minus as revenue the XX% commercial net defined commercial of sales cost record the

P&L top be profit net the slide, our commercial collaboration net revenue. profit our this XX% as for recognized axatilimab, example is there in where of of will period the a share on During as

net would line the expenses loss be ]. axatilimab, where commercial recorded a as separate in [ commercial the The regulatory we share operating XX% a of as will net item statement. a of included collaboration Incyte bottom received various that the on there milestones a designated loss called global and milestone is as for example During income milestone loss revenue share period from revenue of our slide, on from the be in commercial our

for is development Outside including included and [ of R&D a we development As to expenses, were partnership, research the over U.S., under States, reminder, entitled regulatory the sales. With Incyte responsible our share with our to me statement income is Michael. milestones XXX% of our expenses on shared double-digit expenses in let and in part receive ex-U.S. call regulatory as United that, back expense. CMC turn the the XX% of and and XX%-XX% ] and the are royalty a

Michael Metzger

Keith. Thank you,

approval heard we progress have us you first the are and As prepared during and FDA months period anticipated our the over transformational tremendous ahead launch past few made of for of well call, the X medicines. our with

the for have impact we continue the the our fuel drive Slide built clinical and to path excited believe recap of we With our value. to a of ahead you about are we the momentum we anticipated can opportunity revumenib see potential patients. On milestones major XX, will a have designed strategy make and robust development we that and and full upcoming our momentum axatilimab, to explore

to and importantly, to want to always, the families, inspire in continue work support and patients all thank call for and to our lives trial I I our participated our of trials hard gratitude long-term cancer. our that, in work also partners ways who who to operator. I'd vision investigators of Syndax. With have team the thank for share to to committed like with the questions, building express investors want our I Most and would commitment open their dedication As mission. us like improve sites and with and to new Syndax tenacity to my patients, the their finding our

Operator

[Operator Instructions] first question Our comes JPMorgan. from Anupam from Rama

Malcolm Kuno

will force? now Can revumenib what scope remind the of potential of actually is efforts approval? ahead This for the and ongoing you then Kuno the of And Anupam. medical sort field from axatilimab and us of you education have size Malcolm

Michael Metzger

Malcolm. question, the for Thanks

over it to turn Steve to address it. me Let

Steven Closter

Malcolm, for thanks, Yes, question. the

think I wide In terms XX roughly like XX, of in the opening the was sorry to for comments range. size,

I it's have treatment given haven't We've formulary. got it's We exact and a adequate that journey staff got an overlapping pathology But field number. physicians and cover to treatment the centers They've and for lab complex nursing patients. mean teams. in audience.

I got cover, to So teams We'll I the XX% different said we've opportunity. that. cover of customer-facing think

in place. The field So is it's team activating.

say organization, for I other what an question now think are to things. do the I'd was education field right really around and your trying we're we as X doing.

KMTXAr, We them given of accounts, they that to they how profiling patients, I for they're do that how business, understand journey. any treatment on, want how institution see the mentioned like is we call complex One on those learn [ ton a nursing There's how treated. drug, they for clinicians, highlighted how get us to role for understanding from the deliver to for of to staff. patients how touch ]

So that priority I accounts this -- than in XX% we more them I the are at the them multiple we've and also think been of I We've been them. X,XXX it some of I to of of made about point, probably calls. that half XXX mentioned to call accounts. mentioned, we've already that

that's patients in launch, order on we drug So profiling we're need know that to accounts, to it. the at the time goal is and get know and of thing that's everything and doing, to, treat one

piece. is standpoint. here Second a of education for menin the bit is of disease little the There lift inhibition from mechanism piece a

] So about really effort at least something ] [ raise got that of our from non that Clearly, talking [ the the that's raising else also a We've going standpoint are personal awareness to be the is awareness. are a teams only delivering. mechanism, commercial we're one out. to but field not drug,

the by we tied be get should to time launch. level awareness the So

raising So gets the awareness, pull we'll drug it in shape to approved great be profiling, once through. between

Operator

Goldman Chris comes from question from next Sachs. Our Shibutani

Unknown Analyst

[indiscernible] Kevin Chris. on is This for

for to half. the studies talk the about Just in second combination wanted revumenib

And recommended rate safe will the are pivotal update be? And have trial? Phase what that dose about you'd data the also establishing respect with you then forward into are AML how where I BEAT year? steps You said be a to II you the bookend believe trial? talk that going Could the start you there? And many then those what could trial, doses of from potentially, updates. limiting to end to for can the then trial an bring in by you just there's highlight

Michael Metzger

maybe So I'll address Kevin, that.

the BEAT -- for AML So there. trial I'll AML BEAT the start trial,

As you presented know, recommended we're Phase both tremendous We've looking II progress a EHA, dose. data had for of doses. at we those the made on

in the -- process X We be II making of soon to least of dose, at filling out choice weeks. out some have we're Phase the those that expected the the between working going which a X next through and be at we'll doses filling recommended number just is point doses, over the patients,

So we're the trial, pivotal very good year, ultimately, we this end believe, shape, of start to by in trial. a

] MD relapsed/refractory for updates Anderson. the is so trial additional that tuned This at sorry, cobi [ -- Combination Dr. -- this last presented [ ] safe as year Guise's in again, get on We through And we revumenib. is presented -- the patients. ven EHA stay data we and at ASH. year. In plus trial, at of

exciting the time. But expect additional latter of data. But say course, half And So not updated of it that be to be was told that you the at do in we at us will this exactly follow-up. this presentations year. patients, some is more there to we're liberty where investigators as know, there

that well. we're anticipating eagerly So as

Operator

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

Unknown Analyst

for brief have X I ones. [indiscernible] is Phil. This

see X the your later you of [ revumenib the believe second that for [ launch? and is, was even is, there's been treatment to doing, centers or setting, though ] any commercial could the perhaps like ongoing relative [ now trial were? And work of revu what benefit late if prep all Like in do target the estimates one in that for or time delay INTERCEPT updates there can maybe first lot the prep you then It trial? maintenance that a see can or work too there, has between and I longer came any internal from are question that The ], I a use the see you benefit you've that sort ax within ] been we trial while. -- learnings the monotherapy in to any when the to wondering accelerate data launches?

Michael Metzger

the question. for Thanks

commercial I'll you the Neil that then asked, your will and to question. ask First, address address Steve question trial

Neil Gallagher

think the were trial. you asking INTERCEPT I about

at the is INTERCEPT trial progressing I'll it you're we a present as for we third-party trial understanding you is ongoing that exact disclosure some meeting And data. the our has planning are it well. aware, recruitment The that. firm, that been control future, will expect an So first right, of therefore time. going is well, your But relatively well for is also on we investigators Steve over don't data that, question, have [ a medical the in but to With pass ]. actually don't

Steven Closter

Yes.

reiterate, really the extra particularly overlap of first was the sort the X compounds. of time, question to the just So benefiting

an they speaking So never terms wish I -- in where less experience, time think just of more speaking, in from approval. someone of been the advance period, and there's a or really launch had time they pre-launch

the think time. more they always, wish they is I had answer

in [ we So I've state anticipated. The that otherwise described more We'll obviously than activity and to work time all put we will revumenib doing. disease disease have profiling have enable we're ] before mechanisms would and ] of the awareness us [ the of the if over there's be -- all be takes accounts most to use that And chance approval. it there we will at of get them, I multiple mentioned, a good them, not good however to we'll times. us the and X,XXX long

mean both axatilimab. centers, to What axatilimab revumenib tremendous and academic cover we'll transplant of leverage we all there's opportunities. but I we're able [ you'd under is XXX by covering support that essentially So that made, there time. And be we'll overlap have that number to think be the shared I -- the centers treatment I right community don't is for I ] X,XXX I covering the revumenib, point of by GVHD, chronic think opportunity. covered them -- for all we'll with think the that in that all now off

in So hopefully so some connectivity particularly as accounts ] of as to those, treatment. those and lot move our potentially and with we're a rev, [ There's advantages patients on we're continued between profiling early there's actually hema well. essentially, transplant and go transplanters,

always drugs strategically, to it's trying The both do we've we're organization. as aligned call -- to highly an call same So the that are point seen point. what

really product ] we'll, make for can given market. the leverage accomplish I comes we said, like so, have use So to we both, and now, time and [

Operator

from comes the question next Our of line from Barclays. Peter Lawson

Unknown Analyst

Peter ] Barclays. on is for from Alex This [

quick clarification me AML separate question from this ] then year? later for see Phase -- X data Just initial see I we a Do BEAT [ we can combination from And is, in data see do on plus XXXX? we X your study. study a the this more

Michael Metzger

AML, for mentioned think BEAT is this that not we had our trial. obviously So I

information have the could collaborating closely there. could going in was We the the -- so come we are a perfect pretty comprehensive of don't at of be when it the done at meetings. with that But update. sponsor. it have possible don't this It's one second yet was knowledge But EHA, half We update be last updated. that's year to medical

going X the stay [ we're yet given on initial then putting the we as X ] data guidance that initiated, we've So tuned be for when haven't that. And plus to that. Phase for I to together

likely in XXXX. tuned. XXXX. expect we So wouldn't I would in That's come have that to stay it

Unknown Analyst

I? you Or to what have of may And risk enroll in sort being follow-up. patients are a patients of just types quick the Phase enrolled initially? adverse here if Do I

Michael Metzger

trial. don't about that I actually of exact type think we've Yes. patients in we're enrolling the the talked

that think X -- they're patients diagnosed X in ] combination. I with plus just [ newly

Operator

from of the the question Canino next Brad comes CFL. line Our from

Bradley Canino

This is Brad.

it around clear of some review. think revumenib good to be the up I would sequence

of lot ramping the a and vocal presumed [ about the that had visibility line, collaboration FDA RTOR and get needed with revised think of at you really us PDUFA. plus that this it, good or what before the to either that across I closed you're you commercial about ] well

help bit what you happened can of So understand a here? us

Michael Metzger

on agency. The under and RFIs NDA. under that RTOR since latest information of information, RFIs X I'd say last quite is they news been unfortunate receipt going us Friday in then, actually on amendment. this catch would -- been an came in that's up and Once process requests a that, last of we've I supplement earlier Look, many -- the they receiving week information -- X-month That's year more information they the to were for to received resulted clock major were to And in were Friday were in X submitted that extend back is to we from this sense think a as I where we when able with agency. out. require few from of late the we that going think of ongoing them the you delay. know a last -- a the the the since bit going our spend let time

believe, within we that we the that right, So the of reviewed months you're many -- the closely provided, could over The been have them. working PDUFA. information was with were and agency collaborative and with we have been very time quite actually

And them. us, were [ following. that they a bit That's we We the confident extend That's quite to decision. their the were surprised the so up that that, process was that did. we clock, ] agency little were but for would

said, not So they the didn't It in were at we review, -- new and they review, they so not information the was -- as us It is it asked late requested the provided cycle. of it, not of new look, and information that for that we to we learned in sort we was is unfortunate did something and ask had this this information this it This was is I for of without event. -- was it. The clinical they but it our review of about part when it but wanted prepared that information our only we ask NDA. that NDA. provided late-cycle have for previously through time mid-cycle of submission that. and gone did they that We for, the the

the confident first So agency, we only through quite everything with were we submitted been in we that but what had feeling half. in not

the drug approved they've the are of as the we very that's date. extended on that events, December and So -- will this confident timeline those sequence the get feel

think good a very in, before FDA. we're So position to the drug launch I the

Bradley Canino

because are where asymmetry for I that, at us a on there's of follow to information. potential think a heightened just of maybe And situation many now looking

looking to You've cut able and assurance can data been prior what got we at haven't remains give data the guess, you FDA potentially consistent is we that I that overall profile vet. that that from the know reliable? revumenib publicly

Michael Metzger

is assured specifics be -- an us what's -- not that late-cycle review, RFI risk-benefit of ] going consistent what manufacturing of asked This say review, program at in and -- profile can they as AdCom that can required the This looked get for. that well. for we being our REMS they've a into the I clinical and no not Look, package completely learn that at to of the and we [ but changes It's the [ ongoing mind I and product, anyone's that for us be or the ] in the there's is did is information don't I approval. information information supportive no think will all.

And even for agency package for, basically it's the more what as they feel actually of information. so, worked supplemental and on. a asked previously asked robust It's we had than

change the all like get on that feel or we're it at approved only risk-benefit, not with that's we reason, it'll but so profile as approved, drug So the the to for having will doesn't do proposed. why the that and anything timeline get confident

get So detailed that's as I could as I pretty briefly. think

Operator

of Guggenheim. the Michael Schmidt next line question The from comes from

Michael Schmidt

just follow-up. Maybe a quick

extended date now with wondering So given obviously, time just September until the for giving RTOR of half PDUFA extended for is ahead approval under And what the on review, a potential the the revumenib your FDA, opinion? end still and NDA, an in on date? to the is your that follow-up. of PDUFA had come view still table, unrelated Is that then an I

Michael Metzger

RTOR for X actually weeks under the extended and RTOR, with seen products, unprecedented couple a approved extended approved or got being We've about timeframe -- got not extensions. Rezurock either extended got one their PDUFA. that of It's earlier their than

RTOR course, it the they that if the It's under before, approved hard not very extended of review, Many Most meaning to that to PDUFA same -- date. they're to that's we've and for on distance, be the case products very extended go get will will but removed seen extended get us. date around from or priority expect hard judge be products on we or do the of know itself. it's thing. We can't or whether approved. very -- their So time

or will or the expectation that on on before have So date that -- they is it our around come specified.

Michael Schmidt

unrelated in that we relative KMTXAr, to of to just for then, follow-up, duration related relative the subset And a assumption the how good modeling about this in dynamics NPMX later that, patients upcoming about of thinking And NPMX should the transplant KMTXAr? sort data -- market registration In to Perhaps year. therapy subset? think what's for

Michael Metzger

datasets. across think the Thanks has for along NPMX, KMTXA Look, the measures that in with we've between trial question. the the seen that data the been the consistency NPMX our I I what similar very view all seen to we've all Phase looks and

also considerably cohort And patients I that be although perhaps the mean, versus the good a includes of seen little a proportion KMTXA, so, also So transplanted. in to get those we've what NPMX tend in seen we've transplant. patients older,

It treated to to thinking more to they've a preclude same an cleared enough way, way tumor the a of physician urgency there get the transplant. transplant take their patients them they're in to patients are and who the from while be that So KMTXA by healthy have may doesn't physicians, versus NPMX.

that and seen have dynamic that -- with KMTXA. as has with well seen NPMX we've as again, So we

of to view this but patient then even patients population. and slightly potentially is to model, on go happen your of though even we be model is So in assumptions, our would them and the post-transplant, percentage transplant they a that terms of back on drug similarly modeling course own very who older go

So of KMTXA. that's Phase we've pivotal and on the our I to for our from knowledge think trial the information now that I best based seen in

Operator

Our Kelly the next question of Jefferies. from line comes from Shi

Unknown Analyst

[ Hi, Clara for is ] this Kelly. on

for likely would [ possibly pivotal Committee the ] in Inclusion? the that readout with [ that your KMTXA, change upon now be step this going you So payers what approval will that ] NPMX update ] be maybe had conversation data as And also, how will with in forward NCCN one like Guideline to and have well? [ discussion

Michael Metzger

approval. but longer it's NPMX the here other mind will data question. have proximity of in now seems be on the our trial of the for in to no our cadence another, pivotal to Look, Thanks around. ahead KMTXA They'll way events be think I close our we one that

we proceed be to So that will can. NPMX. KMTXA, drug guideline first, having as published NPMX for with the as quickly can inclusion potential our in data data once priority approved And we get is

of there'll then on approval. sort affect at some the same we fact ahead in an could that's indication be that but another is the move the to So [ cadence urgency ] [ drug order be which SMDA of process through here. And and quickly have to guidelines ] time, moving included NPMX, through the in market a in

So over approved, the to ad on about to included moving other get publications drug new in there thought basis, guidelines leaders with the only conversations related who Maybe but an it will and will, be not turn if quite talk a hoc I'll guidelines. to questions. also bit of work through getting activity Steve to drugs you

Steven Closter

Yes.

my talked NPMX? expensive. payers Part I think in XX% is been X which both managed comments on cover So, part We'll in I the about with ]. care is B our have lives opening commercial payers, what impact talked of that payers [ and activity to of has

of data they $XX,XXX public a to point the what slight believe the with the payers. Payers what's seen those we'll set and $XX,XXX roughly recognize premium is this want point to They like the price payers, to like think see KMTXAr, want between we revumenib, they've be published. they They this in KMTXAr. in a unmet see need we'll domain. month, I agents. given NPMX. entree case in and in recognize where at Clearly, the to connection It's That's NCCN to obvious guidelines see They price. guidelines. the

fantastic days We've distributors some I products products specialty they ] when launch upfront the think when this. portal service hurdles patients a They'll to and not and a got do formularies. of pharmacy yet always through obstacles like partners are needed patient with want and [ usher early payers on to barriers, and patients. which produce

preferred as understand our as as we So institutions. partners treaters as medical process [ well pharmacy the well ] and exception

So the right get be with set we're challenge, but able do some prepared it. and and able on patients we we'll we'll price, think to either there, to be drugs get way to we'll

Operator

Next question comes Citi. from from Yigal Nochomovitz

Ashiq Mubarack

Yigal. on axatilimab. I for just Mubarack one wanted ask is This to Ashiq on

of is you up ] the process? sort which you label could there Sounds wanted everything track color ] is with of soon. review? mid-cycle to value reached in [ maybe on PDUFA, pretty would are Was Anything confirm anything is share sort things of ELA that on to negotiations? any the with very where helpful. if the be track just coming like know on Have [ I ELA

Michael Metzger

Thanks question. for the

review, as So comment you the any on part process. negotiations is of we agency specific remember. during discussions don't under priority the our or with It

in whether approved around the are changes August. process expect do encountered are which As will not discussion, the or confident the we very and will of but we drug we are to be feeling the said around its be be PDUFA the in well. that label point on we that view. I along, approved date, approved it's review won't we've comment We specifically going timeline. drug Nothing that end of is

Ashiq Mubarack

Should a sort commercial commercial coming place some with there think we a of waiting of be that's So one might synergy immediately then. sort follow-up well? there after to take that to of maybe for a up? a potential as on is Maybe launch bit maybe little the approval launch lag that reason there's revumenib? expect a Or

Michael Metzger

quarter. follow-up, launch fourth is thanks in the expected said We Ashiq. no, the for the that So

ready launch the that's our to drug get We're that, when do partner guidance. to and we'll So our ready. it's with working

Operator

B. Riley. from next a Patel Our of question comes line Kalpit from

Kalpit Patel

learned I filing maybe of 'XX could and there Is revumenib. a there first you that And for Is says help here the 'XX. a regulatory I reason timeline KMTXAr from anything for the first have then NPMX that quarter half one sort Maybe that? filing the for know and that? be beneficial that streamline follow-up.

Michael Metzger

crack Neil Let me to a to over maybe take turn at that. it

Neil Gallagher

Yes. Thanks for question. the

is question yes. So straightforward answer the to your

that lot And, about a important we've of it's and NDA So to distinction process. the the think SNDA. between the draw I course, the learned

in subsequent ] the of supplementary done, more do is heavy application much So [ lifting any application the a and NDA, we straightforward. lot -- is

question I excited quarter, looking There be as was So the missed? to you will possible. fourth questions, all be data a there filing was and can submitting we're I getting and obviously of or as forward that data Did NPMX sure we during expeditiously the or something probably I those your missed. address

Kalpit Patel

for Yes. It's instead of filing for -- 'XX quarter just first the that just cohort? it's first NPMX half 'XX

Neil Gallagher

Yes.

], We haven't guidance been here pass specific -- I'll I'll our put pretty you [ that actually to at ], can sure that back with it hard [ be we it. that working be Michael. will

Michael Metzger

second question? your Kal,

Kalpit Patel

Yes.

Was there then is the the here. any -- FDA to related NPMX sent the of set update? part of data I was guess, second by FDA, the was question sort for new So requested information -- the that cohort was and that this

Michael Metzger

been hasn't focus not even even KMTXA data actually with That's on -- the And No, we're we're working Kal. trial. just But FDA. would what through the now the NPMX I submission.

done hasn't it of been All yet.

So it, when available fourth is is that we'll trial will or the the publish be quarter. data in and when that available,

KMTXA. -- with on So you to should agency the the information we're that focused relates

Operator

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

Justin Zelin

cycle of your under a approved a accelerated approval review Should could expect to approval like approval be where clarify scenario the the I'd to end confidence traditional here, could revumenib Michael, continue an on or we in the by the basis? year. regarding there revumenib be

Michael Metzger

a assume way than should this to you that think be is going don't other full approved approval. any second I other for in

process. have the targeted through therapies precedent of drugs All in AML the in as the been approved that same -- gotten have monotherapy exact

approval so, that's that we the pathway and with would pursuing And is never accelerated -- the there not we're here. no agency that's been pathway, discussed

have is have just the high filing process assume what to what of at in all doesn't and not likely this at change And for that, months. at would we're would a delay change It we're I we X that So confidence of all. that approval. terms

Operator

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

Cameron Bozdog

This for on the on progress. Jason. is Cameron Bozdog Congrats

comment to uptake, of potential axatilimab, at hearing prescribers you largely academic near-term I from the at versus So analysis and driven to about internal been the when mean, RTOR ahead [ your you've centered think ] you can what you centers on least community administration? looking initially, prescribers? especially by blocks, maybe launch be expect do market transplant

Michael Metzger

going Steve to question. the to it over for turn address I'm Thanks it. to

Steven Closter

lot small off it's in of a a high science saying, pretty experts I'd [ field there's and of transplantation. ] and the start audience

may centers. it's the earlier, XXX. XX% standpoint, a I from have treatment So provided numbers of center I under -- think It's the

So by all driven it that. was

to of in academic drivers, this. the who's think centers the going I community, drive the are part all it's, versus biggest

part, there'll For awareness ] that. launch, [ in center, the XXX be the at the half outside of most some even And there's see certainly that the probably within XX patients country.

audience the So community. in, call it's the it of wouldn't it's to is -- tight I say one it's but smallest smallest. And a physician

and market disease. opportunity, there's lot treatment unmet It's dissatisfaction want a a to GVHD ] They There's agents. insidious current business more. more They of speaking need think population. I here. really of [ in lot need the a

not there's but early a of I'd this. uptake like say some and -- are patients for it'll number probably a waiting. of be It's huge group So waiting patients that something number,

and the well ], ready patients. and be shortly market's will it'll there by received be and ready bolus too [ but I So of will form think some be physicians

Operator

the question final from our from Farmer of comes Scotiabank. line And George

Unknown Analyst

Chloe [ Zhang for George. ] is This

from So X us.

information of that you Michael, ODAC said [ are did you your question the now was package you how be the based you revumenib, [ to So confident subject BD proof the not [ months? And review necessary. additional FDA ] So ] and be that second ODAC ] the for that next believe in case? its X Do initial prompted data so on thing is, extension remark. still submitted you the will mentioned

assets I'm you eyeing ]?. any areas So curious BD just [ mind, those types what deals interest, of in ] types of of you're of [ had examples

vital for you time? ] do if tell the [ over it And could even Incyte evolving target. or you the the are at relationship those in that maybe context moment, a us us to put of kind and So how see

Michael Metzger

question. Thanks for the

required. agency one ODAC, in augments occasion of only this. and first, clearly high that the think be more our referenced will that data an of supportive submitted, submitted. of that us we is confidence not So I only very on The in we've terms than as I degree earlier, and package minds has approval told The ODAC

risk So there's is, really doesn't we seem of -- and on in there we've that our minds be know. to based an agency, from there what any the ODAC heard

speculate feel therapy [ in we early-stage well And we this at how which and at But then to it's we acquiring the and of BD they're don't essentially publicly. hard development continue on mechanisms of relates conclude to we feel which or on adding that. And an when licensing on until looking about is do the backfilling in quite focused discussions terms and grow is doing oncology, -- to [ the usually oncology. We them deals, our confident I and or ] Syndax we interesting very which in we So -- bring the to or pipeline. do in question specifically ], potential. molecules what do about molecules about these after going done about we them in transactions good at part, of targeted to said business the quite past speak But the pipeline as talk and we've in new the work are continue stage, any this what actively and space that add closed. forward pipeline status point, bring we're

time all what accommodate have projects we take and and an to earlier for -- with we so on our of late-stage the we axatilimab be looking interesting in the type whatever projects. the we -- revumenib. So things on we're but not feel it complexion -- going do this can variety, pipeline seems Earlier will like of other at of are a type for

that one engaged and strategy balanced we in. a actively it's are So

Unknown Analyst

Incyte future? to seeing, respect partnership thoughts that see the the evolving been how in you any on we With have with

Michael Metzger

announced about, when that good in They've Our Earlier utilization partnership We with back we're keen to talked Steve of IPF. Incyte been we're a conceived that. and treatment variety course and the launch that, we to outlined one. indications. of certainly get it partners approved for axatilimab as launched, product and pursuing XXXX good we've And us. is the in expand a in GVHD,

way And expand -- believe So and it these partnership Incyte is we and we that's in well. to quite in this -- gone it it's continue continue that will so the start. global are envisioned a flexibility with to

happy we're that. So very with

Operator

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

Michael Metzger

you for wish our tuning We forward you so have We to the Thank seeing we that, investor with in made and [ the you the company. a we planned all upcoming to all. the Thank ] discuss appreciate day. in conference you BTIG including exciting milestones good August. ahead you today And progress at events, look much.

Syndax Pharmaceuticals (SNDX) 1 Aug 242024 Q2 Earnings call transcript