SNDX - Earnings call transcript Q1 2024 | Syndax Pharmaceuticals, Inc.

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Operator

Good day, everyone, and welcome to the Syndax First Quarter 2024 Earnings Conference Call. Today's call is being recorded. At this time, I'd 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 First Quarter 2024 Financial and Operating Results. Officer; and the this financial company's Michael Chief Klahre an to results Sharon Metzger, on update progress Executive am with afternoon me provide are I Dr. and discuss of Neil Gallagher, and Goldan, Financial Chief Steve Chief Commercial Keith R&D; Officer. President Officer; Closter, Head and joining the for call Also the Dr. are session us on today question-and-answer Peter Scientific Dr. and Officer; Ordentlich, Chief Anjali Ganguli, Chief Business Officer.

deck the This calls page posted of company's on been the company that by the has a website. slide Investors

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

like you various section including be Reform historical of that I'd risk within made to Form materially reports in with may the the the call not important in XX-Q discussed Securities statements other Act meaning begin, are during filed from quarterly Actual SEC. results are differ indicated we Before result Litigation the remind XXXX. factors, the Private as the these those forward-looking those any report factor of that by most statements to company's recent considered as as on well of statements a

forward-looking completion. views company's today, www.syndax.com, only. its X, XXXX on this as replay be website, our statements of may May A the call following of will Any represent available

Officer over With to pleased the to Chief Executive that, I turn of Michael am call Syndax. Metzger,

Michael Metzger

that we we keen Sharon, Commercial as benefiting on place of to years Closter as winning his prepare commercial you, excellent to March is call. brings you leading the on good successful the in to experience in thank and insights and by for He product us prior Thank teams framework Chief Steve establishing and building from are commercialization. Steve welcoming includes morning, arrival, which launches. joined over the his call already joining to like for Syndax, and was everyone, begin today. I'd Officer. Steve XX us

we corporate the progress our on against strategy. significant executing In quarter, made

for the priority can X, this see both we Slide securing several from significant BLA including NDA filing. the filing you review and the quarter FDA axatilimab milestones As revumenib on achieved

AUGMENT We of also which expanding trial, completed serve We quarter supplemental enrollment NDA us bringing in initial the of filing XXXX. fourth of step year, from look as to half for the forward data the one AML the in opportunity this trial revumenib. market could basis for XXX pivotal cohort to the reporting the NPMX in closer first a

acute data for us versus set we KMTXA for graft accomplishments in in for expect U.S. eventful full of trial combination NPMX revumenib revumenib in axatilimab, as data as combination disease. initiation up well that and X KMTXA host These pivotal will with frontline of trials XXXX readout, an in regulatory leukemia and approvals, X include additional chronic NPMX venetoclax a frontline initiation pivotal combination for the NPM

NPMX drugs potential target a and best-in-class Syndax as to and in broadens patients. prepared quickly potential has rapidly are possible. our quarter ability with ensure or X,XXX profile biotech indication approvals, as on to patients Notably, working approach successfully during preparations will at near-term As in on setting cusp details time additional the any a we later provide need in to an significant or to the revumenib is we differentiated to expansion X This with unique SMID-cap relapsed refractory in call. all population in the approvals. the a year in the expected for market leukemia. fully relapsed opportunity are patient launch we acute their launch first our as it a Steve that up second revumenib as refractory has the third opportunity meaningfully of launch that extends Xst reach

for years significant Multiple assets, for and that drive are these trials come. both long-term can exists refractory indication to ongoing franchises opportunities initial the beyond value relapse or for

are in funded with significant million expect capital through well we XX XXXX. will provide as We March of cash that $XXX

commercial trials, our sheet pursue balance core supports and select launches current opportunities. our clinical only indications but business also to not development registration Our and planned expand allows beyond us

ask Neil? pipeline. I'll provide Neil overview an of to now the

Neil Gallagher

the of Real-Time leukemia. XXXX. NDA And target of being reviewed date PDUFA and KMTXA Michael. the is revumenib which review In first approval for date to you, a a of priority granted of historically inhibitor has treatment filing KMTXR pediatric more process selective provides September the time. efficient Thank the or acute relapsed and Oncology men quarter, highly review filing XXth this is or the Review, led for earlier was by The our FDA adult refractory rearranged under

on is cell where responses to high acute patients, trial free from a pivotal single-agent slip percentage enabling revumenib based on and The the X, lowest transplant many induced KMTXR blast leukemia pretreated them of heavily curative undergo outlined AUGMENT-XXX of thereby to submission the of AUGMENT-XXX refractory potentially data Slide to relapsed this to patients the We've NPMX continue quarter of March XX from of monotherapy completed fourth revumenib following enrollment the final in year. and also expect trial in cohort population the report in this pivotal results adult AML pivotal transplant. and

or have moment review The consistency mutations enthusiasm on presentations generated Phase inhibition in NPMX data reported of an ] KMTXA the refractory us we've NPMX the both population. important our supports NPMX. or refractory across the a I treatment in to conviction highlighted and receive confidence relapsed that for could Slide NPMX this building and pivotal rearrangement results and settings Phase revumenib patients [ be for data men frontline I revumenib our for that the underlines the with AML by AML. and take X I'll that the relapsed Multiple

transplants. of patients the I KMTXAR patients prior to or of response MRD proceed complete high overall CR and cell many And the having have responders NPMX venetoclax of XX% This Phase to population, partial revumenib is and In Consistent importantly, percentage transplant, achieved of responses and an enabled XX% failed achieved therapy a negative. despite remission recovery. part also with AUGMENT-XXX, were patients NPMX CRCRH the pathological prior the with with stem all durable. been XX%,

refractory relapsed no QT or AML. experienced grade patients events. It's X been in no Phase form revumenib and adverse revumenib syndrome that prolongation No X with patients were the NPMX worth due tolerated noting backbone We or X acute there leukemias. patients In of grade treatment has I, NPMX the KMTXAR treatment-related believe and than that patients greater both differentiation events. discontinued will to for well with

the extends initial frontline beyond or and Our including the post-transplant clinical with and refractory approved strategy combinations populations settings, maintenance into relapsed therapies.

Slide effectively data including of continuum from Phase combination and with listed of fit in including and multiple Investigators ongoing trials, several with standards of trials Hematology unfit have X. of presented patients, AML, across that AML the are the in on revumenib's to the care We BEAT December different during I SAVE care. AUGMENT-XXX safely standards combination and American ability Conference the combine Society demonstrating settings

first updated from another with In this as later chemotherapy, X+X. also we care the quarter, provide data I to trials Phase combination trial known year. these expect We initiated standard of intensive

we're Beyond opportunity the solid the leukemia, to tumors. to expand investigating acute

phase we signal-seeking proof-of-concept update cancer progress clinical the colorectal this quarter. Our to dose and I the later Phase of on trial the expect trial of escalation metastatic is an provide in ongoing,

first review of of PDUFA host at XX% disease for with of therapy on date rate systemic the graft the based pivotal after led lines or was to XXXX. responders Also treatment response AGAVE-XXX CSF-XR in at Turning the August X failure year. chronic in submission priority filing of FDA data of overall X. trial or with GVHD antibody by Slide with single-agent versus XX% the least of the for quarter, granted axatilimab response is XX, on prior X an BLA axatilimab a for from The axatilimab treatment chronic to still

the combination the a care It fibrotic the or for the mineral fibrosis are [indiscernible] lineage agent approved first idiopathic with bone fibrosis enrolling Importantly, a to investigational [indiscernible] diseases from and of chronic inflammation disease-associated axatilimab where where through into GVHD. macrophages. [ the currently setting excited has mechanism including action ] is Phase macrophage We're chronic to in opportunity a differentiated II axatilimab target trial. of that expand clinical inhibition and place currently other standards we monocyte frontline therapies of about GVHD

axatilimab's the revumenib, impressive fibrosis-dominant The for the key potential consistency Hematology/Oncology AUGMENT-XXX investigators in clinical axatilimab LCs Society mentioned European across respective highlighting the the of the the working from supports team in additional data investigators Marrow earlier, the awareness the data plenary of session and Pediatric pediatric groups. has in a presented that Also activity the increase from as at compelling of April, Congress, presented been is data of hard ahead of point In Transplantation differentiation. and American approvals. AGAVE-XXX I to which, further organs, Blood AUGMENT-XXX of April, AGAVE-XXX Society

to axatilimab and we way, clinical We publication detailing prescribing the have of community. of forward ambitious that revumenib the benefits more plan an look to and

our turn and now to for the over I'll Steve? opportunity. planned preparation call commercial to about launches the Steve market talk

Steven Closter

Thank you, time to launching and an Syndax, X we're Neil. looking at meaningfully is year. forward to This agents first-in-class be differentiated this and exciting

to be earlier, health the quarter full progress of we've patients, professionals revumenib ready in both medicines care the launch made far to market these the we'll and prepare As axatilimab in Michael to realize this potential ourselves third so and for indicated and company. significant the year for

areas X. key Slide are Our highlighted on focus

health relationships infrastructure to external as provider care with an and well uptake and the strategy space on the purpose-built focused pre-commercialization business Our payer developing has to efficient, in launch. effective prioritize at the accelerate important as stakeholders support

support been awareness, launch. mechanism access as patient ensuring education For place time and activities services well the around of centered have revumenib, at as are in prelaunch market disease disease our of

understanding leadership and on with in health some on organization customer-facing most and workflows accounts, market, state team has care care The our helped has define important largest profiling The the providers. health health valuable This us outreach time providers, actively field us the journey with have influential and and the is at gain another academic which awareness conversations decision-makers focus and relationships centers to identifying disease strategy. team the insights allowed in has been patient building the for country. care

We will segments of and campaign approach well This follow-on of launch. acute improving as the as leukemia, expand launched like across effort NPMX focused the a we a around role rearrangements inhibition on nonbranded as key [indiscernible] including knowledge last potential year, mutant KMTXA understanding AML. indications

in team product an relationships Hematology/Oncology of of experienced in and proven a a an customer-facing primarily years field We highly group per professionals success. with very health average sales average obviously and multidisciplinary patients. is X The a XX with supporting talented representative. play with launches care experience recruited past will This of team and existing experienced role

approval or With timely conduct builds to over decisions market and regard on of formulary and upon been educating access payers FDA relapsed commercial reviews refractory prepare acute evidence-based burden the to ultimately, them time. to has approval, our Medicare access, team potential leukemia while and

acute and and the the acute to I'm doubt We sharing excited future. that date and for than leukemia due formulary expect product in be little have the recognize about of more since prior anticipated to quickly, are market as could review by to with been and important covering disease to while data. revumenib to progress supported covered critical. approval. of look benefit more urgency the managers provide and in KMTXAR product or efforts a that AUGMENT-XXX XX% need morbidity for and significant refractory high and pharmacy the KMTXAR all acute plans inclusion. We've the reimbursement XXXX, revumenib reach mortality benefit will relapsed to our meeting payers and forward telling the leukemia, unmet information absolutely revumenib's plans nature the us ongoing making our they that Payers This patients sharing lives treat about is relevant

the acute this pricing no patients represent a Turning is estimate incidence addressable such now million market KMTXAR across acute to Slide of there of $XXX frontline X therapies of competitively clinical all leukemia the therapies a months of acute data and population. are alone NPMX We median relapsed XX% X,XXX [indiscernible] approximately targeted treatments. targeted or other represents KMTXAR AML the U.S. therapy to AML, leukemia and for majority treated duration leukemias in the believe of inhibitors. up patients, in and annual X. KMTXAR believe The refractory to population total supports we standard We and about or the IDH as are refractory to approximately FDA-approved

monotherapy more to an continuing early and with following then indicate to eagerness eligible revumenib extend we've revumenib spoken bring patient's transplant responses engraftment. prescribe journey Physicians during treatment patients to by transplant with an

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

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

are There cycled being Turning progression, suffer current XX% additional this through patients manifestations aren't now wholly advanced inadequate Approximately Patients from to the and disease disease Slide for corticosteroids physician's with are addressed. initially chronic population. treatments. no therapies the U.S. on second disease GVHD patient that require based addressed XX. manifestations treatment chronic of then XX,XXX whom to of line or experience a with due beyond response of cures variety treated GVHD,

agents importantly, the these gained in GVHD. chronic Rezurock and Jakafi successful the both need speed unmet really launches The by which to adoption of speak commercial and

advances, that impressive physicians fibrosis leads and also looking a with address are better still agent of that inadequately are onset and ultimately damage. response. a such despite of We disease action know organ for these that treated to drug have the the Further, fast an is they excited to can recent durability underlying

$X points carve market. to within GVHD opportunity should a estimated out commercial chronic sizable axatilimab of enable U.S. key These refractory the differentiation billion

our As the for the and leader GVHD Incyte in space. is partner you know, really axatilimab,

a exercised As highly to commercial axatilimab benefit universe. United we there of and the products and option in overlapping last of Incyte promoting simultaneously year, as to XX% to provide we prescriber targeted X co-commercialize believe physician a States is efforts the their with considerable

go-to-market We're working our fully develop more axatilimab closely Incyte sharing to align insight before with for and details. additional strategy to plan with

imperatives for revumenib. However, as we expect to just follow we've a outlined strategic similar of set

Now call over the I'll our to Keith results. turn to review financial

Keith Goldan

Steve. you, Thank

Turning to Slide XX.

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

the importantly, Our allows value a year. of financial commercial pipeline appropriately us our strength organization this to into stage and to transition invest maximize to

Turning embraced in million of year resource and Keeping of of in comprised a $XX.X guidance first to we've $XX.X for and selling, mind administrative the general of the second the and expense that million, expenses provide to I'd disciplined income allocation, development Operating XXXX. financial full statement. always were quarter research and million like to expense. $XX.X quarter approach

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

$XXX For guidance. million expect the $XXX the million. to $XXX XXXX, expenses no year there is be development million full operating to and and to change research existing to $XXX to be The company total expenses million to continues

provide example recognize intended guidance. an margin to any revenue accounting that launch, Slide of inclusive illustrative not axatilimab for minute lay year noncash ] And an out the of compensation is Note expenses other stock includes take XXXX to operating and to million want of for sales how for we range plan for preparing full for for the estimated [ I XX $XX is expense. axatilimab. guidance to or a

partnership with the XX-XX of economics is the our U.S. Incyte split Commercially, in a

sales commercial We net revenues of will report of XX% of earned and cost expenses.

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

XX% axatilimab, for item as collaboration in be net commercial of a expenses slide, a loss share laws. period of example operating would line post commercial net there's included where loss as separate share a of in designated bottom on the During our the the

various included R&D and is income part we ex responsible royalty Development development or are on and expenses statement recorded the in Incyte to future XX% are expenses of U.S., as milestones partnership will the shared Outside for share in to our entitled is as XXX% sales. expense. receive on commercial our that milestone from U.S. and statement. of the the owed U.S. revenue plus and We have income XX-XX us also U.S. be regulatory milestones regulatory Incyte of

turn over call let me now Michael. that, back With to the

Michael Metzger

Thank Keith. you,

prepare XXXX market. as we you've determination is launch resources and products, to the confident to a expertise, As and heard I'm year X products have Syndax we during historic call, the these be to to for that up shaping bring first-in-class

As are options on excited are a patients evolve organization, in need. commercial and important bringing an we truly to organization, into we to these treatment laser-focused

On the Slide coming you XX, we lay progress our out upcoming forward in for and our year, milestones the I of key on look the updating balance all months. to

appreciation and like Syndax with collaborators and our improving on our are my so we your work with lives trial mission would express team, delivering patients, of clinical our patients cancer. the to to sincere and the involved dedication, sites getting importantly, programs. I most to ever investigators always, the Through close As of

to to like thank also us vision that, for our committed I'd in support open building to questions. and call investors Syndax. who share in continue With our Operator? long-term like I'd the

Operator

[Operator Peter Instructions] question first Lawson from Our at is Barclays.

Peter Lawson

question first be initial just get the as for of additional is to NCCN revumenib. will around approval guidelines indications important how Just

Michael Metzger

ask to of Peter, thanks Maybe the for the Neil on the question. I'll importance guidelines. comment

Neil Gallagher

Yes. Thanks, Peter.

know, and anticipating you that be quarter, KMTXA-rearranged acute first and in approval, approval as the leukemia for third first children. we're come for the revumenib that the in So adults will will

to the the data the fact, I in in from included the pivotal that, that have cohort the the anticipate that of end And -- will sufficient year. we fact NPMX by approval indication the addition remarks that be be we guidelines. referenced we've So -- should actually prepared to also will during guided in reporting

least at start the So plan, to publication presentation have in us regarding mean, could the suffice along committee with to approval, at inclusion conversations the I Congress Medical of guidelines. a to NCCN prior we that a position say data with

once new important at once but they a the twice meets disease-specific ad-hoc, a aware, the As data committees year, year, ultimately committee become least available. you're meet

we're information And So to when of want to clearly, all prescribers we possible sure committee make well the as best is data. made the considering we as that. our to available that publish

Peter Lawson

And of CRC should this think detail number of about if expansion then expectations could still tumors, kind data kind the when around kind the of to conference of and patients. medical that the we data the just you as expect see XQ we solid [indiscernible] of that's the

Michael Metzger

Thanks, the follow-up. Peter. for Thanks

to solid disclosed work remarks, So is And plus. line of there. area as related prepared the colorectal tumors continuing we to and we've metastatic was in our in third question cancer are cancer. and colorectal mentioned This plans the

and are case. I to -- disclose we a that we our had information, are in these Phase So everyone We had that the there conducting planned remains on be to progress update trial. quarter, said and second the some

Let a trial. this remind dose me escalation everyone, is

So patients months, disease this this to prolonged for population, of X range of is roughly is what XX looking category. the disease to XX% patient the around perhaps essentially And again, call revumenib that in XX to pretreated. activity looking X patients with we're in in looking it, see heavily stable -- for stable

So sort impactful. we that think, of that's be, the would signal

do that and of course, in doesn't don't nature. standard stable well disease very yield prolonged setting patients care certainly Of of this

we'll obviously So update the to in second when we're so ready do quarter.

Operator

Anupam Our at JPMorgan. next is question from Rama

Anupam Rama

quick for one a Maybe Steven.

really these for for Just And axatilimab, being Syndax actually and you revumenib products? the your assessment to also wondering, you Steven. joined what of is the were before opportunities one then attracted second you and

and are Slide the you'd of for broadly some X highlight? specific to in of anything KMTXA these for You but levers success mentioned that revumenib very more launches, both what

Unknown Executive

Yes. the I'll both. answer question. Thanks for

is, probably And career. it's I the course a come really of of my over been careful First pretty I've things combination why here? did

is this think years. my organization XX in I fourth

And different at is pretty X in I opportunities factors. So the look bar high. all

great AXA that. and amplified. I the products with that be and that knew market been that I've of and and And And reviewed engage to only KOLs, as products that have of provides both products, need, have unmet clinical lots a actually amount REV The data I as data really coming think in. seen that's I've research attributes. first address is differentiated needs great

and Michael, a second the tier, sort wanting right, all was in have think who the great about team exactly I commercial what even with, is I place that to leadership strong that and well. entire people that's ELT as think be and supportive [ companies we really work the great with are leaders, thing Board in here. was ], top very walking the I

for here, for and thing plan third success, have the willingness is that and invest And me the we really too. to

I'm have my I I'm in excited exceeded and X. say more I'd started, before So expectations it now in, think, even been was than coming Week I

for be we're a around in question of will second success place. There's all and as organization, lot The is that commercial a building on revumenib. out really levers

Michael I and ready think as QX. mentioned mentioned in be Neil remarks, his will in

All those things processes. infrastructure done. will be So

really, first a from view immediately. that the are We is fragile. strategic the know about think things patients is population the point of X but will limited. them focused That right? that grow I think of of that, finding is are need over we I very opportunity time, They treatment on Patients critical.

got focus there. we've So

that thing multiple sorry, the engage advanced think second address out I -- stakeholders that patients, you care with deliver it, we delivery. that footprint landscape just care name we'll reimbursement, providers, practice pharmacy a there and nurses, directly nervous health customer-facing pathology, is have physicians, dynamic. the of to There's

important for treatment. data, is that. mentioned They're need but will point looking third really looking NCCN access payers be Neil guidelines, which to are patients the other who published And access. for

in against really payers a we which and And space their So we've of the been we to formulary for with built some making that addition, directly know expedite in support the effort calls review. is needs program need. deployed time, meet to payer an patients,

a So thanks good that was Hopefully, for answer. the question.

Operator

from Brad question at next Our Stifel. Canino is

Bradley Canino

gain the evaluate confidence the both time-to-event the the plan year, also updates uncontrolled for combos order move emphasis how and to does later clinical from data durability from will Relating and endpoints combo trial want this be remission by frontline to endpoints CR year-end. to in the the company of the NPMX randomized towards ask, pivotal OS pivotal. and plan from the the for I [indiscernible] trial to in initiated pivotal monotherapy This to

Michael Metzger

to that. for question. Neil going it I'm address to thanks to over Brad, turn the

Neil Gallagher

Yes. that Thank we on, initiating the to mean the this in [indiscernible] -- you combination question. scenario, by the other reported the for of studies study specific one I the all Specific Phase III the last words, updating end And year the aware, anticipate study. AML data year this we the as the group is data of those and reported the you're around course during meeting BEAT year. ASH -- of

data community. not company the to investigators, actually only the investigators BEAT are broader not but Those exciting, but the to the also AML and just

people highly the So Phase ] enthusiastic associating are [ III study.

Just to higher remind including compared you, exceeded the much, to have much AML terms the in [indiscernible]. response date CR observed in controls rates study molecular in of and rates, the that including historical the to BEAT MRD-negative were observed CR/CRH in was BEAT AML the [indiscernible], particular, CR,

the to not it population. it's as that providing the be doesn't in backbone patient data -- So target well toxicity is combinable, adding to the observation efficacy including revumenib the therapy as highly appear adding emergent -- being incremental

of with from, observations trial, a for is the SAVE bolstered population and with in combination -- as a trial relapsed/refractory AUGMENT-XXX in oral revumenib the a the combination which study, setting combination well with refractory chemotherapy. combination our as a by that's venetoclax instance, is also And -- in decitabine

trial. revumenib body is III evidence the standard Phase population is with for is toxicity not the the combinable adding backbone of the in of that target So care

the to trial II/III fit the is backbone data therapy. evidence Phase the For population NAV providing also the notable diagnosed efficacy AML that and in adding revumenib

on conversations more the but comment prior trial, we to the typically we having those, don't the to study design be So and as we we with later presenting authorities obviously, look around health year. details in initiation will forward

Operator

question next Our from Phil Nadeau TB is at Cohen.

Philip Nadeau

from side. A progress. on Congrats few my

doses trials the validating of are combo in the the II doses Phase terms II in First, trial. phase combo the in

morning's validate release some notes been press doses. this that expanded to the have trials Phase So II of the

is disclose Just those going the dose curious combinations this monotherapy to in whether revumenib you'd of at being point? used full whether be

Michael Metzger

Yes, go ahead.

Neil Gallagher

the Yes. Thanks for question.

the everyone, studies question studies X remind to referenced the answer the that discussion. under in to are just I So just the previous

that of strong the XXX all that milligrams what studies the XXX with in all dose repeat the of those presumptive would and [indiscernible] monotherapy were combination in XXX not those milligrams I In included are. of -- investigated. label. X X is milligrams. revumenib trials, So doses X there be will in those were

been at time all So the last full the around event X ASH by revumenib in at dose talked trials has we about given them December.

and X the both dose-limiting expanded all toxicity doses trials in are X, both point doses cleared at all time. this for being windows been in In have

-- care. we haven't backbone doses. is is standards that in X RPXD, our observation general, with full when that is anticipation to we about So combinable continuing talk dose monotherapy revumenib we're date at But to the characterize revumenib of

Philip Nadeau

the axatilimab. explicitly in the necessary AdCom And That is doesn't very helpful. comment drugs. based remind you're be for or then FDA would milestone advisory like anticipating accurate? It say question, And you acceptance for either letters just not seem revumenib second presented. the on both the tables Is review that that an you can that us

Michael Metzger

question. the for thanks Phil, Yes,

relative neither correspondence but I nor explicitly regulatory comment on that. think we we agency that from haven't in like stated require revumenib our order things to is axatilimab AdCom, will expectation an the

So will AdCom. an expectation but is our that that need neither --

Philip Nadeau

us. from question last then And Perfect.

the assumed is patients. of You in you proportion what X-month Can duration to that for transplant use us KMTXA remind going expected X-month of figure? referenced median patients

Michael Metzger

question. roughly Phil, thanks transplant. X/X path, for the of It's sorry, right? go that that about patients the of I'm

Philip Nadeau

transplant So to what get who is you relapsed/refractory line go the in in assumption? X/X of patients

Anjali Ganguli

Yes.

Phil, it's Sorry, Anjali.

population. were about basically X/X be transplant. I been size did of the an trial saying that seem not on there's responded, of to X to respond. equal Of seem went think There the what is groups half X/X patients based of all that patients that we've patients

population entire So to go of X/X overall, the transplant.

Operator

at question Michael Guggenheim. next Our is from Schmidt

Michael Schmidt

will launch in later $X this billion trajectory, axatilimab setting, early now should NPMX in And one to year. the as think where the then perhaps off-label should the the the relapsed/refractory subsequent wondering have about think expectations opportunity on how data could what at, to proxies approval? we in Are you for sort had just help on I any your accelerate the day for this early they launch we closing that good subset? to year the potential of $X.X PDUFA And are about on. we use next year, that billion later look there launch example? just Obviously, obviously

Michael Metzger

Michael, Yes, on thank the to questions. Anjali comment going you for to I'm the ask launch.

Anjali Ganguli

No. Michael. Thanks, Yes.

excited We opportunity. about are really this

what it's situation. unique think has revumenib a very I [indiscernible]

another X got you across dose the adults you an patient pediatrics. and support that to know, development said, in generated AML anticipating we as ALL in through We've NDA we'll and we're first important exact for indications data And -- best clinical time, in the record their As have care by filing approval year, years. in of for the care population disease data third quarter same this patient the where patients. can physicians treated very providers health options set choose and a of health

and as to that, about the then data generated, use recommended top combination fit think all it of talked treatment that we've drug this they on to allow and we've think multiple -- them we also So plans into their about ways best.

a can So seen bring to the have next to that I in have addresses we nothing. XX there's be what's months, aspects that don't all how I launch significant analog coming have generating these time. but very going think we had think of a utilize that it perfect to they curve we're care unique patients [indiscernible] real of in very

you'll as focused launch sure a in Steve that there. out all that is how aware excited think to we've lot make very the last education support really we're been the of revumenib. really and place ASH I patient data everybody a and strong is drug, much we're support And to X is recall have of been about, generating to and utilization talked allow shows that more I And there's think the the have already meetings on doing

Michael Schmidt

just under Medicare? us percentage about the of AML you of Can sort sort year. how programs what is you pricing follow-up. of Maybe early just drug as think market the a again remind we think free this in And later launch population, for the about do Medicare expectations any

Michael Metzger

Yes.

comment those Michael. I'm to -- going Let questions. thanks, me ask to Steve ask on

Steven Closter

over time, for guidelines on the launch age honestly launch for KMTXA the process. versus That's Yes. meanwhile, I providers, to formulary It KMTXAR the for now And will payer fluent commercial based question. will very coverage expect medical mean health the different be through it's the a space their are happen and right, data. published acceptance are X of staff in We'll months typically more on a patient. at the other is NPMX. helpful care patient of good where they're to the takes that happen. how to NCCN But exception for X get just

will but bit payers KMTXAR, is to patient to be for for which less going due a Medicare it's the older, change. NPMX population, important little

months, has information even So to been all our been We've over pipe year, it's exchange. X the That's and a delivering grow last pre-approval really exchanges. plans. approach really information the

unique with So said, a criticality got interactions recognize it's Anjali we've say need a launch patient followed of some as care. very year. with the unmet good the within payers. I They had launch you've by And where think another a launch

whole so So for the both payer same space. got build time coverage we're time. at takes preparing the we've It to

remarks, of prepared XX% advance that my we approval. as in of will country, gets in it as is cover in I lives talk to And think which good covered this payers

success. prepared for we're So

Michael Schmidt

for a Okay. that from potential year? there question filing just as we milestones housekeeping are Great. think and you our the that, then incorporate models should any maybe do And Incyte this axatilimab about approval,

Michael Meyers

Michael. Yes. Thank you, Keith?

Keith Goldan

in Qs Incyte. not -- $XXX million. milestones agreement and and Michael. in do and Yes, Total as milestones the do Total disclosed commercial with have for the we Ks, $XXX We development past milestones were only milestones, but do and under Q as regulatory development us disclosed from regulatory commercial million. we've

do us. total million So of a $XXX

You come as such events those approval. can major to expect regulatory to

amounts. a expectation, that's haven't to more we reasonable specific the think but been as I

Operator

Nochomovitz question is Citigroup. Yigal from Our of next

Yigal Nochomovitz

pathway is regulator the follow break may our or you -- path, even NPMX options those NDA, given really or here that necessary? on Just are not

Michael Metzger

Yigal, thank you your for question.

You broke it. I I think a up but bit, little captured

you So therapy we've KMTXA. had designation as for know, breakthrough

molecule your opportunity For and potentially NPMX, to been and strong. the package submission therapy most for probably we indication. get engagement has breakthrough the I have very think the around the first important KMTXA And

We priority review as have a well.

the us. don't but with on But point we're, a we say, agency, well in way think the generally BTD the our we've to for regulatory we'll to same what's strategy, at by say to come already. some access leverage we'll but comment I for future NPMX, what of open the look opportunity -- I'd submit advantaged points pretty is

program look have I in data the that. And that we'll obviously hope, future have the this in it's on later we beyond then We'll approved a a So think drug year. submission, not-too-distant to get XXXX.

So sNDA process. that will be an through

an that I'd in may of in pathway some through all, the ourselves say, avail it's So hand things have the some or already it, we future. designations of expedited call we the

Yigal Nochomovitz

revumenib be and a that both the for around broadly revumenib patients and whether set. with the you frontline the commercial of refractory or Okay. in more there, setting, setting they're and assumptions of potential when that your assumption that be chance there's start the then refractory And part in in that in of with patients perhaps even think are frontline trial build retreatment you the to the for to those received frontline AML, going you're the with making in once combo think frontline the When then in you relapsed be the pivotal build relapsed in the in care a the terms it the venetoclax. in revumenib wouldn't initiating treated including good about revumenib fact a commendation spectrum about a [indiscernible] given or

Michael Metzger

Yigal. Thanks, Yes.

want Neil, to I least frontline see you're way I to today, be going setting, vantage likely it the with in treated that think menin in it's point, [indiscernible] with treated the do the less treated think you inhibitor. relapsed/refractory -- we make our comment? a -- think you're the with setting you're assumption once our I that once from another And is again

Neil Gallagher

KMTXA that longer I relapsed bit canister in expecting they a could, a shouldn't because it agree point, for Michael's general, treated category. been we that with with later there fall think and agree But time can foot positive had think patients that I I sort be I -- Yes, NPMX long term, of re-exposed. or might I general, is think situations a in positive nuanced -- little to foresee Michael's instance, where be around I lot patients of

Yigal Nochomovitz

for on terms the in And lines enrollment IPF Do any of have trial AXA. just one data? time in you

Michael Metzger

not No, point. this at Yigal. Thanks,

nicely. enrolling, sites enrolling are patients, we as know, and going you we started think recently I and up bringing it's

have we'll for next year? milestones, to of as get in maybe both enrollment as say so as we further And well data terms more into year, into the

Operator

question Patel B. next is Securities. Riley Our Kalpit from at

Kalpit Patel

to median comment that and consolidation? that relapse/refractory treatment that that a study. higher in of you as I'm receive frontline after in X would duration setting induction proportion the the eligible understand be on Can of you revumenib maintenance what be might to estimate months expect treatment trying specific than patients you

Michael Metzger

the question. But for Yes. thanks

should be in engraft think all patients for I who all and correctly, going have to a your patients usually interpret transplant, well. that that's think for if an I had question there's necessarily that, terms of engraftment would I purposes, if that first remind relapsed/refractory getting need if successful eligible you're intents physicians would setting, be be eligible. for But think all us stable They step and And I of no maintenance. the you period. eligible think and maintenance reason in patients there's be I the --

that's, discussed basis. that's So our on think, ongoing with physicians been I an I and assumption think

setting, to for and able transplant to in the frontline I patients you put could and well would back that think ] get through how assumptions to therapy. get out [ them treat very earlier the when population maintenance FIT successfully if on were play them you the long-term and differ

treat better do think -- to they earlier, on stay patients stay expectation I and longer. on they they is the

over And that front assumptions to little work that on time, We that don't understand generating that good change on time estimate relapsed/refractory. so we'll should a have how better. we're the a compared yet. Obviously, the line maintenance of bit in the data. But

Operator

is Jason Bank of next Our of Zemansky question America. from

Unknown Analyst

progress. Congratulations on the

plans Regarding you do there's outreach. a community-based How focused quite on treatment, commercialization to imagine bolus but academic expect? do the expect and initially excitement I the But what straight-line least awareness adopters revumenib right bit of descriptor and as you come quite rapid community. isn't across to your of patient a already non expect between maybe goes more board do of initial at maybe division sort and latent quickly more for patient bump more have far uptake? the large education or and prescribers numbers given an in to as dynamics you the

Michael Metzger

going for turn to over Jason, it questions. question. address your the to thank you I'm Steve to

Steven Closter

mean I question. a the for there's thanks of lot Jason, excitement.

bit quite medical [indiscernible] has boards done KOLs, the the market with predating met research, me there. company, a research, think I of coming to company the has out advisory been and team

I've Sloan lack demand lot a there's recently at in with that's of, of say, because and out options. treatment and KOL. meeting to yesterday So there was what York actually Cornell of New

literally it they're the So for ready hits wait the drug, until cannot market.

there I or a will product. They quick inhibitor. centers, So ready academic this whether fairly think certainly, the Jason, uptake. [indiscernible] high already Awareness be is for are it's

of of see I they little lot a think it initially. going a community, patients downstream the is may to bit just take time. of in not Part it's

be to to it's So there. up us

station of not We'll we'll as nonpersonal that reach we percent have in to XX-plus be places frequently. program commercial standpoint, the will a that promotional a So from have opportunity. team, going a cover adequately sized may that's folks at

patients lot just board. you'll a is think across a in I uptake treated. ready be So the to of office And it see quick the

So We it's EAP, certain patients, the just cannot leads high. there's to right? for number, bolus I going one have too of to to patients. second is I question, a the in and -- think but withholding place. your be not give that's point, is an number of No much your treatment criticality a It's eligible

we'll EAP, the extra then just months over on initially be there'll assumptions little and launch. from available a expect out And uptick burn beginning after our that of say, that, use will based we'll typical a the So patients.

Unknown Analyst

in on I it. Phase metastatic Makes just colorectal quick Got your And maybe a sense. cancer. follow-up then

opportunity? potential you signal, investing I significantly about of I maybe you this a solid a is expansion specific that confident stabilization menin's there but in know, In just know hypothetical mentioned terms tumors go for no in don't feel you're make disease I curious, role terms is decision, that looking would of no, or in driving important, [ ] potential was biomarker

Michael Metzger

it to Neil thanks to I'm for on CRC. follow-up the Jason, to over going turn address.

Neil Gallagher

thanks. Yes,

I the just safety is this So in part of conducted mean, primarily the the -- has reiterate a study been that Michael's of study. part point, safety the I date, to

addition will on future at responses, get data. in safety this to looking the responses. We're I we we biomarker in And where the future development a mean, as to be primarily looking at looking could solely anticipation also but also a decision is that's We're are taking at that clinical clinical make point our in a space, consideration. We study. into

specifically more in that. haven't But the necessarily for pursuing I instance, expect point be [indiscernible] wouldn't but update second some on, into we'll at, are take around said future, consideration. as I correlative at We we're And much the data we said, our in too provide looking details in quarter studies. will what assured data correlative data. we rest that correlative

Operator

Instructions] Our at Zelin next Justin from question is BTIG. [Operator

Justin Zelin

Welcome to Steve.

of talk looking So overlap how who treat for to here? to products. of could ahead and ask large both build to sales of X launches I promotion this graft wanted year, you disease versus you're both a force of chronic providers the host And leukemia

Michael Metzger

let Maybe Sure. take Steve that I'll question.

Unknown Executive

question, the appreciate Justin. Yes. I

to of will I In be the sales of the team. exact think prepared address really we're provide color customer a But it can that inside not team and size, terms needs.

that system it's delivery it's experience. great care whether anybody providers health goal, Our within the customer a

of health So to the providers and sure to care treatment in organizations supporting their needs link to all prepared meeting different of we're make aspects patients. up we're

So I think coverage. I used the term XX% plus

So that. cover doubt we'll There's no the about opportunity.

the In obviously with overlap point. treatment of transplant. There's provide of third of overlap. right, GVHD high now same with it's overlap XX% audience or there's audience. along that treatment between on centers, calling of a terms our the leverage we're AML right Incyte REV, mean the of And we'll call Rev Axa of whether probably likely, We'll treatment effort. and I

really the will opportunity opportunities. both So cover in we'll market leverage footprint, we our and

Operator

Sachs. from question is next Our at Shibutani Chris Goldman

Chris Shibutani

A have asked. lot of been questions on focus already the

can there, second in I guidance in step-up to a your full question studies, if a as to have R&D. combination considerable Keith. just primarily The a ties your if looks to year a bigger of little reach on attributed is it we'll the operating it give bit terms question, half. perhaps the So us to guidance, spend ask sense picture, Is near-term that longer-term

company are is secondly, to capital think focused a impatient building very tremendous as appetite? out Anjali, and and thought business development? your What could What now on What's is investors of But X to on in you then launch portfolio the this you've figure done amount trying you I And there? work your know, try priorities, out what allocation further come next. are seeing products.

Michael Metzger

first Good longer Chris. term. the you Maybe, on questions. take want Great. Keith, the one to do

Keith Goldan

sure. Yes,

did Chris, $XX million So step up ]. We $XX words. necessarily to your use wouldn't is quarter [ second to total I million. to close million that expenses agree $XX XQ it's operating a guidance for in big The range the

we'd just So to that be on million-ish. stay trajectory, if $XXX were we

half the the accrue. to back So that's And think of Phase combination certainly, to with in the that anticipate pivotal launch trial expenses combo X+X continues R&D Banesa first-line year. some would the in to back REV IPF I ramps there going certainly yes, [ as of as I we the increase think, our year. half of as some ready REV, to with is III the get we add ] And

building also But organization. forget, don't a we're out commercial

on commented as some individuals SG&A the earlier customers facing -- growth G&A that expect Steve force. we sales well for side, would for on field the support there So all the force, those for the that as

Michael Metzger

Chris, business terms development, of question, to Anjali. start turn it on your and second I'll over maybe in And

and look, in-license model differentiated time, with business pursuing has which we've profiles. to same is some So for been molecules quite new develop think and the been strategy our I

be to I high think about molecules strategy so in-licensing how our we've bar we having been X approval, nearing with and quite and us fortunate is success to these allocate gets it and to capital. new regard are the great always upon that incumbent thoughtful have opportunities with

the pipeline them doing that that. pipeline, important, interested the And do in we backfilling we think the is quite additional are of molecules, and so bringing part earlier into

what make our we're comment on we if don't remain I about doing. disciplined Anjali, And know so but you activities, want quite a to

Anjali Ganguli

Yes. sources opportunities market actively a lot there's lot for looking some share, well, it variety in very new you time the No, Michael. said diligence look news hopefully, a and exciting a spending I of definitely engaged of and have We're to at. we'll but on to think across

Operator

next at George Our Scotiabank. is from question Farmer

George Farmer

too call something on other of the that like well competitor yours as in the has morning. A been greater menin hasn't and There you're therapies talked much their about inhibitor inhibitors that detail? about combining targeted like. about Is that this conversation with thinking FLTX

Michael Meyers

question. George. Thanks for the

is on of the of is let else Obviously, on strategy population relapsed/refractory in Neil terms perhaps option combinations, pillars therapies. targeted ongoing, another I'll going the ], the we earlier unfit Covey patients and [ Banesa being ] patients if in in interesting in and our will, So you maybe then have trial what as for with well. comment is [ the and

about drug's So it the ability already to ] the just in relapsed/refractory think in terms FIT combos we've chemotherapy, side that of be and with combination of combined in equation on spending. then then the with demonstrated [ chemotherapy

comment the open to We'll some there's also which about us. that. on if want extremely we on so updates this And talked year, data combos those. far good. But options Neil, have Ben think know data of on I looks as have to I don't We'll you additional

Neil Gallagher

sure. Yes,

conducting investigated. mid combination very revumenib which will [ trials, technically in will strategy. with So Michael's NPMX or in ongoing, to or mutations storm FLT gilteritinib -- be our pivotal program core the initiated are be -- FLTX investigated for in instance, we really challenging. or either -- is with have planned the in ] It's and population both patients point, frontline which we invested To not either

what haven't with our we'll then initiate that but dose will -- that which Phase obviously, we overall it's is said XXXX. by X+X, to we initiate Phase were revealed course, in strategy. to year-end strategy to plan we FIT ranging Of the in II is, that addition What III position not to during core a our combination initiate us

patients that, and study. large a very anticipate that's will be that complicated dual-mutation can You in not because

population a pursuing potentially registration as to that in evidence generate to prefer strategy. we opposed So

Operator

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

Michael Metzger

you, and of the all you Conference to Thank in tuning and a look Bank all investor in operator, thank events, And great May We in with your day. that, America today. questions. at you you wish forward for planned conference including the our seeing Appreciate Goldman June. Sachs you we

Operator

joining. has you now Thank meeting The concluded. for

may now disconnect. You

Syndax Pharmaceuticals (SNDX) 8 May 242024 Q1 Earnings call transcript