Earnings call transcript Q4 2022

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Operator

Good day, everyone, and welcome to the Syndax Fourth Quarter 2022 Conference Call. Today's call is being recorded.

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 the review of Syndax's fourth quarter and full year 2022 financial and operating results. Officer; with Company's afternoon financial progress Michael Chief and update provide results Klahre, Metzger, the on and Executive Sharon me to this an are: I'm Dr. to discuss of Briggs Morrison, Officer. and Goldan, Chief R&D; President Financial Keith Head and the us for today on Dr. question-and-answer Also are call joining session Peter Officer; Scientific Ordentlich, Chief Dr. Officer. Chief Anjali Business Ganguli,

statements This call the slide now page the of a to Investor We turn has can X. that is deck accompanied on our forward-looking Company's by on been Slide website. posted

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

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

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

Michael Metzger

Thank today. joining you you, Sharon, to webcast and you on the thank all of

of put delivering need. Syndax. areas patients which to stage biopharmaceutical turning of commercial great made We products progress becoming two high for firmly growth Slide unmet goals, a best-in-class to working path execution all of Now X. our integrated strong XXXX of was on year company medical in and fully towards long-term the a us

a data relapsed/refractory therapy patients enrolling progress, variety Society to Hematology additional pivotal that the of further clinical AUGMENT-XXX regimens. Revumenib, in in best-in-class I two with Revumenib's combinations trials robust leukemia trials with test Phase announced acute Further, designed made designation breakthrough On rearranged Phase presented I and American including in Annual sessions supported XXXX initiated standard-of-care the Meeting. Revumenib oral updated we patients of for profile at we KMTXA settings, significant

in progress we I/II For set made Journal enrollment Oncology program chronic partner, Clinical in the and data with development trial, of axatilimab completed our in published axatilimab, initial expanding pivotal the the graft-versus-host Phase collaboration the disease Incyte. AGAVE-XXX

are have help collaborator as axatilimab successfully to We fortunate Incyte a to strong development. us advance

into our we million in Additionally, us XXXX, balance is follow-on commercial with half allowing of business of value to runway bolstered XXXX pipeline, the appropriately cash two $XXX.X to pursue extend prepare December, in potential for offering, development maximize the a sheet now our expected potential U.S. opportunities. our second to invest and launches

registration longer incredibly XXXX realize unending us to year and a to which treatments. both live and the for and drug that forward marked that ever patients candidates, this an and better by critical significant the filings be on year with pivotal determination execute commitment I'm the is focus, our along readouts determination for people we first with XB to and resources we confident to in our before. year, which of has best-in-class goals, are expertise future than will potentially expect Our have propelled cancer and Syndax,

Starting in leukemia acute Phase II X, summary patients pivotal trial our our a or selective rearranged Slide KMTXA of is current our Revumenib well. progressing mutant priorities. provide to NPMX Turning with we highly inhibitor, relapsed/refractory high-level corporate Revumenib, Menin AUGMENT-XXX with evaluating

with rearrangement registration the basis for sufficient filing I on happy to more data completed call. provide quarter a will top the We of of report of third enrollment later by year-end This track to we a patients support have number filing, are and to we KMTXA are that line report would a in AUGMENT-XXX on provide the in trial the from NDA details XXXX. an data XXXX.

In with in Revumenib medicines in of earlier to of lines to trial, care we therapy combination the and leukemia. testing of addition standard acute trials ongoing treat have AUGMENT-XXX these forms

this potential to important therapy. committed the of are We unlocking full

in goal expect top readouts patients, that several chemo in dose first to with initial have cancer. relapsed/refractory and from metastatic escalation newly solid in These concept include trial phase combination data acute trial from tumor for of XXXX Revumenib. AML data data in of additional line mind, proof the the Revumenib the line from patients BAML With cooperative in combination top we venetoclax/azacytidine, initial of data safety diagnosed AUGMENT-XXX leukemia trial in colorectal

report trial, against evaluating our top to We BLA line or a patients cGVHD, versus the to submit axatilumab disease host CSF-XR. on by XXXX. pivotal mid-XXXX to Phase track filing graft in the and end with in Moving of data antibody from remain plan axatilimab, AGAVE-XXX II chronic

be value anticipate a in the as well axatilimab of additional combination trial first later we of fibrosis, as and a in off the half year maximize that axatilimab of pulmonary To we to axatilimab Incyte in anticipate this Phase the expect in in IPF, initiating kicking including program, XXXX, frontline cGVHD we trials XXXX. idiopathic II that or ruxolitinib of

to bar in-license with any our is our current continue We pipeline complement would oncology we bring differentiated compounds to high-value potential could so believe fit to evaluate as earlier-stage in compound assets that our strategy. have quite for new to assets. we that doing but targeted need sufficient believe long-term corporate and become early-stage We opportunities high capital in

X, the Slide to revumenib further provide program. I'll turn details and on now Let's

ALL, percentage The patients overall are of AML. secondary independence, response, patient you endpoint including the of pivotal pivotal KMTXA CR/CRh Phase independently. safety. is II designed portion rearranged primary with single-arm and trials endpoints, transfusion As a of of durability populations three each AML patient as rearranged with These distinct recall, enroll CR/CRh is trial achieving survival mutant NPMX KMTXA AUGMENT-XXX populations that and

presenting the lymphoid acute acute we the and treatment all acute approved The KMTXA be for leukemias. address whether breadth to as pediatric for if or up to all KMTXA relapsed/refractory unmet received the the of designation XX% or leukemia, underscores of acute for Therapy or In first Revumenib accounting December, needs for with of BTD medical leukemia, to BTD Breakthrough in Revumenib adults myeloid patients rearranged drug phenotype. of receipt potential

of on breakthrough designation the acute KMTXA Based conversations both regulators, and generated will indication investigators. cohorts relapsed/refractory our the a Thanks into at AML to support to from with therapy pool ALL-KMTXAr single and with filing the the data an rearrangement. treat enthusiastic ongoing we all aimed broad leukemia our patients a NDA

a enable strategy. this trial patients the in KMTXA Phase We of number portion have already enrolled AUGMENT-XXX to filing with sufficient of the rearrangements II

quarter population the treatment end for adult to relapsed/refractory an third patients in top NDA the by expect KMTXAr share and We file from line XXXX. data leukemia of in acute this pediatric of the and

for AML well, expect we these to patients continue report and Briggs? there are where on Annual patients enrollment the you half second I investigators the at Briggs in was ASH trials for will presented Revumenib excitement relapsed/refractory to we of mutant Slide take completion Phase Separately, updated These enroll significant Meeting enrolling by through of X. in December, and NPMX data XXXX. that

Dr. Briggs Morrison

so All much, Michael. right. Thank you

AUGMENT-XXX two attained from as in Ghayas for Of portion, a in last Anderson in the Center Annual updated the MD Phase the XX% the Meeting results CR/CRh. I from Phase of Dr. oral of Issa ASH So efficacy XX you presentations. the trial Cancer portion I at the year, patients December presented of many know evaluable

patient negativity high of a X.X patients recommended transplant. duration rate is dose, very months. at both Phase as population was potentially and at in median population patient which impressive bone XX%. And to the notably, treated II CR/CRh, achieving MRD this the patients CR/CRh to in There this response CR/CRh NPMX KMTXAR advanced was meaningful proceed was in at curative among subsets enables patients it XX% same The marrow of in very

who And patients with treated a data therapy year maintenance also then or additionally, on in a XX for a capacitate compelling response patients remained cell treatment on reported in transplant use Revumenib the non-myeloablative remission who boost, of cell of over setting Revumenib We as following cell stem whom data three stem cutoff. two stem transplant the receive on went to achieved were and transplant.

design As setting. well Revumenib in continues and a Revumenib pivotal been maintenance potential tolerated, discontinuations can role Revumenib the the have marrow in on bone reminder, restarted that be data transplant, there patients post-transplant to adverse due the of no feature be on events. to the trial, after provides treatment-related

we only development look the treatment. continued support compelling landscape, Revumenib's across clinical but first-in-class, profile believe not the we data best-in-class as As to position it a and

back I'll now turn to it over Michael.

Michael Metzger

Briggs. Thanks, Great.

Turning X. to Slide

development have with earlier clinical observed profile clinical use our its seeks in Revumenib, setting therapies. Given into beyond the to approved plan combination with relapsed/refractory settings expand we and and compelling safety

our highlight of trials across landscape. Here treatment ongoing the we full Revumenib

trial. umbrella the with Starting Ib Phase AML

inhibitor rearrangement venetoclax/azacytidine with in expect Leukemia safety included XXXX. is of part Lymphoma NPMX the and the our to who As for assess which Enrollment the data be an diagnosed we is or menin chemotherapy. combined mutation trial, initial treat induction with AML are as this available as in and Revumenib ongoing, Revumenib from with safety to well initial is Society, KMTXA unfit efficacy. being newly be collaboration trial first patients to will

a Longer term, trial, serve we expect filing. regulatory which Phase trial as basis AML could could the II/III the lead future results for -- to that positive

mutant We with acute relapsed/refractory Revumenib trial or to patients standard enrolling NPMX combination the AUGMENT-XXX assess currently chemotherapies are rearranged for also in salvage patients leukemias. in designed with KMTXA

data available trial this initial have to expect also XXXX. from in We

disease This trial was recently in clonal is pre-emptive target novel Master as patients the Group. focused Clinical as and by trial approach on to part evolution This trial. And INTERCEPT in treating investigating their Lymphoma The initiated finally, it therapy AML. INTERCEPT relapse Trial creative Leukaemia Australasian the is therapies of led early to early and as course a

included treatment, menin to designed risk who of following at patients group have the Revumenib, is explore in very a as activity to MRD-positive high the relapse. monotherapy disease initial inhibitor of be AML of with first patients It

the care planning year. the in combination fit in standard in frontline intensive treat initiate that used also in this second are chemotherapy, to We to with We half patients process study of of a plan of the setting. trial

unlocking and full setting by in for beyond to our the treatment need. moving acute more on potential in even and meaningful is shareholders value it X, patients importantly, detailed As relapsed/refractory agents Slide with of has Revumenib the other combination potential in leukemia earlier both approved the for add

leukemia largest forms upwards population, patients and These of addressed to AML expansion various be acute mutant the With see the acute therapies. knowledge, across XX% new edits. potential of up which, to represent two will to NPMX address by opportunities, leukemia of overall of targeted KMTXA these our subpopulation together XX,XXX to we AML the be

backbone of role data report and leukemia continuum I we menin-MLLX currently leukemias. as signal-seeking for explore targeting We the clinical tumors the are supporting that KMTXA NPMX-mutant patients signs therapies expect Phase treatment could enrollment, looking become for anticipate no Revumenib data preclinical acute compelling the interaction FDA-approved in are NPMX Revumenib choice the also There and A in of to by KMTXAr proof-of-concept open line or a on acute solid colorectal based trial and driven to year-end tumors. XXXX. in is cancer top we with

dose-ranging two met AGAVE-XXX trial at and years whose therapies. therapy turn antibody of Slide the has as patients population. receptor X evaluating practice-changing have The least patients potential Let criteria. enrollment in provides axatilimab progressed of monoclonal our after with axatilimab, pivotal this effective has entry in age targeting best-in-class completed to the an two me overview disease underserved CSF-X serve has prior XXX now trial of potentially to overall that intervention cGVHD. the We're an

groups, axatilimab, every once Patients were The two once NIH to investigating primary include scale. of every XXXX given the duration or weeks either -- response response using a criteria once life is every randomized and treatment overall three weeks. the endpoints every or of consensus distinct cGVHD, one endpoint secondary assessments leases and for given four each using validated while quality of modified dose of rate

report top in the line AGAVE-XXX trial We from to continue data to expect mid-XXXX.

the cGVHD, part filing our leading collaboration us, of in regulatory later For Incyte of terms which occur the will XXXX. the be we in agreement, will expect

was the trial rapid is overall that having the a axatilimab Oncology these refractory patients data at would -- and the GVHD at Phase the and pretreated response This in thought recognize to showed the to received These be was in which details axatilimab's have treatment benefit over published a the data The XX, in response from on Phase been December. multiple were I/II well time of the leaders Journal The clinical and presented heavily ability XXXX treatment Clinical prior therapies. time was in subsequently to meaningful benefit ASH responses will in response patients. four portion the provide that profile XX% who rate overall median XX% II results the chronic clinical of Annual in six rate was among was months. Slide median Meeting weeks. trial,

improvements Importantly, clinical cGVHD involved by all responses the symptom reduction in were and cGVHD a systems. in burden accompanied organ

more most common responders of use CSF-XR Axatilimab than on-target Additionally, of the favorable population the consistent of their safety steroids. with inhibition. with reduced this effects in profile demonstrated adverse half a refractory events

Slide begin play and date the Sanofi's profile opportunity cGVHD the important Jakafi with axatilimab expanding opportunity a collaboration clinical XX,XXX from cGVHD, Incyte both revenues unmet meaningful and important broad and given the into are believe trial the expect The in for cGVHD. an role with we We it potential commercial combination encouraging, today. data to that frontline in U.S. has commercial combination with in monotherapy a we to XX Phase safety an XXXX. Thus, in are opportunity Incyte's patients about newly successful the high treatment suffering generated highlights the enthusiastic axatilimab. commercial medicines. program I early speak to and posting cGVHD to in diagnosed complementary with in with cGVHD combination need of represents later cGVHD launches patients with suggests both axatilamab the and medical in approximately begin of ruxolitinib, Incyte, the as commercial [resr] to in and

a could set once mechanism Axatilimab differentiated has to of action approved. these a potentially of benefits products from and patients offer unique

a monocyte into are key lineage to cGVHD, axatilimab the about where Beyond role. opportunity diseases plays we macrophage excited the expand fibrotic

the treatment If setting with cGVHD initiate a to along II the IPF. in robust approval meaningfully. basis to the ex we of envision markets, well U.S. expect to this as trial the the IPF trial, the trial, of frontline combinations growing could Phase XXXX. in for first for in Phase expand successful, additional Through half believe We one III opportunity FDA we opportunity as form

financial call to results. to Keith I our review over will now the turn

Keith Goldan

Thank you, Michael.

to Let for fourth me XXXX. minutes full few and results take year the our financial discuss a quarter

for of our Turning to to the fourth operations XXXX Slide year's XX. The are included our prior quarter the in comparison press results of and release. the quarter

will these remarks. I them in repeat not So

filed our quarter and are was afternoon year Additional available Form fourth financial details in full XX-K. report, this earlier on which

a of $X.XX $X.XX per is last to in which period the attributed point like million payment loss fourth same of share compared December out net of to This million for our the primarily the gain I'd that Incyte $XX.X per upfront net $XX.X for related recognition year. or the quarter or to was axatilimab from difference to the collaboration, into we XXXX. entered share

For year largely for share $X.XX or million a the the compared Again, or Incyte. $XXX.X is to of the million difference XXXX, full in $XX.X our loss last gain net share of upfront year. was net same due XXXX per from the to $X.XX period payment per December

from of quarter prefunded fourth securities, the $XXX ended $XXX.X proceeds of outstanding. marketable and We million completed net in million December the warrants XXXX cash, XX.X in follow-on with shares our and equivalents including million and offering

expected second a both Our aggressive us well in to business decide the half provide selectively Revumenib axatilimab XXXX and flexibility and engage to we early-stage is plans development our current and as should covers as into the programs runway for of provides development. pre-commercialization cash

for I'd financial guidance and year like to full of ahead, XXXX. Looking the first provide quarter

research and $XX to expect to we be total quarter first be XXXX, and million the to to $XX million $XX $XX of million. million For development expenses expenses operating

Company $XXX million, stock approximately $XXX be the XXXX, to total between to operating compensation expenses $XX research For expense. million million $XXX expenses to of year million and of development million including expects noncash full $XXX the be and to

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

Michael Metzger

candidates, of which it Keith. potentially call, lead the With you, Syndax in during you've registration best-in-class in and two our as and and execution, exceptional aims XXXX drug readouts first what heard was of only the treatments. year an And growth beginning Thank near for but represents filings pivotal of trial two the future. potential XXXX accomplish are both to

need. at fully unmet company, multiple Syndax populations significant a serving is integrated high medical of into beginning the a patient of transition biopharmaceutical

potential Syndax's indications, In offer potential. for beyond initial long-term growth franchise opportunities programs addition, both registration to adding broad their the

out I'm goals place plan and on We team milestones and XXXX, execute and have set confident ambitious them. for the that have right in that to we I've

a strong sheet Further, position we are in that with a on balance financial us to deliver allows near-term milestones. key

And want programs. with collaborators thank involved As and sites of support always, our future than continue is our deep us a to most cancer who in who us the before. vision to I'd long-term to realizing on I you Syndax. of and express better trial to execute appreciation people building to investors our committed importantly, which the all clinical in team, also a longer with in It patients investigators Syndax help ever live like share our mission and and,

turn And with for and operator the open I'll it that, the back questions. to call over

Operator

And question Instructions] take we'll from Goldman our Sachs. [Operator Madhu Kumar with first

Omari Baruti

on is This Madhu. for Omari

now is, filing first the from two to AML what consider looking the -- you for And of rearranged are KMTXA question ALL second, our So FDA Revu? cohort first combo see different does and then studies purposes?

Michael Metzger

Omari, the FDA, question, Yes, Yes. I purposes answer question. is for one heard, think answer the to cohort the the the I the FDA as is does first far for for consider you the which yes. KMTXA? as And the filing thank

them sorry, second so We the the you will That's [indiscernible] that, patients And repeat I'm it, combining of out please? second together. hear half cut AML you plan. on be the cohorts, the Can it. and both couldn't and filing question, ALL I

Omari Baruti

Sure.

the are Revu? two looking combo see different question, what you from to So at second studies

Michael Metzger

the said correct? you what we're studies. think cut Once out see I looking from that again, Is it two -- to

Omari Baruti

for Revu. the From combination Right. studies two

Michael Metzger

you. Got

is have the combination addition in with other studies, trials have have later designing frontline which studies the combination multiple setting. beta to with which in and on, ven/aza we we'll the data combo, we trials AUGMENT-XXX, chemo the we'll in year. And we expect ongoing. frontline going So There's be AML, that

I achieve. guidance think to necessarily we what haven't on set we're looking out

of at hopefully these And the recommended the II would we're those I of studies, end a to looking we'll of trials, are be early and first course, think where objective that I efficacy Phase which early by be dose. establish think to year. achieve and main going trying this safety

Operator

Nadeau next Our Phil from Company. and with question comes Cowen

Philip Nadeau

progress. on Congrats

population. KMTXA the on follow-up a First,

well, commingled guess, CR/CRh So for trial, I will it's will myeloid analyzed cohort. the be any ALL the in, combined lymphocytic there AML now a Will be Or disease? XXX readout patients from etiology? and both sounds of it regardless be like the stratification the underlying for versus

Michael Metzger

let Thanks I'll the question, answer Yes. for that maybe And question. Briggs Phil.

Dr. Briggs Morrison

Yes.

So and breakthrough -- KMTXA Omari's back -- designation the first that the of when it that support ALL, recall the is adults disease, beads. or Phil, or accept presents agency the question, AML AML kids. there that whether as therapy announced presented may data did that one the part was you a combination and leukemia rearranged we for And we adults of ALL was to and

break out did looking that it we for support integrated further at the altogether? that the break to agency -- will it is analysis and be we So out, but we'll population designation,

Philip Nadeau

it. Got

to patient that I to Okay. -- them. numbers terms going of being study? of already one -- what recruited the patients not And and were in you've combining cohort equivalent roll of patients the actually not combined, know Is you to number in just number is thought you've said because in required Or we they're the necessarily, cohort really worth equivalent XA patients? of the being XB

Michael Metzger

Yes, for Phil, follow-up. the thanks

in well, on patients specific haven't -- we're we're we think guide not to going planning combined really I a the cohorts. guided, of number to

how not in the are this on that on in we're specifically filing -- We quarter. what the we're that a the it's feel guiding to course, feedback. patients constitute But of by patients the think number year. strategy analysis. aligned I have many that sufficient We'll is end said the sufficient pooled in -- point, based data, [indiscernible] that of at of a have number we're a to will both we've a third

Philip Nadeau

it. Got

based of In enrollment could half the there NPMX on enrollment or for -- be -- in suggest sorry, mid-'XX year, prior NPMX a data Is and question guidance the revumenib completion that pivotal then the 'XX, first of And second data patients? that your data some question last assessment? one on a the same KMTXA before on Okay. maybe is there half the seems Axa. completion fair reason between the in Or longer why population. interval to

Michael Metzger

I think the same rules apply.

we follow the said as the have We're months. exactly patients we'll think being I NPMX six to for enrolled. second in when specific half, we not

bit have rules that's we'll will a going and I conservative in KMTXA six the think FDA project but line I'm all little for as be the that apply be top -- it's to same not we So data to -- yet following when them XXXX, months. the population that

Philip Nadeau

And additional wait then on the IPF last axatilimab. us you question for willing on is details Or have until will the any to Would we trial be Great. provide now? II to Phase underway?

Michael Metzger

and we'll and for we're Thanks trial get Phil. design trial started, Yes. once that to We're details on more the excited share question, the probably obviously underway. the

probably say. think I old that's to

Operator

from next question with Our Anupam JPMorgan. Rama comes

Priyanka Grover

This on Anupam for is Priyanka Rama.

question breakdown? Between quick from cohorts, clarity a or KMTXA on two any enrollment could you provide the color Just us.

Michael Metzger

the question. Yes. you Thank for

line to that, give in we third guidance the two we can said specific that were going data to the and that cohorts. top sufficient provide the guiding number have from As we're contributed patients on we'll What quarter. either complete many the a how we're previously, not of I -- is analysis,

there's now. So I a with be that think for satisfied lot to

I think that's the guidance, specifically.

Operator

comes with from Citi. Yigal Nochomovitz question next Our

Ashiq Mubarack

is Mubarack Yigal. This Ashiq on

the FDA the you time NPMX. on NPMX you number spoken specifically clarity on have Just on NPMX? need of guidance? hit patients to you to enroll Have line with your Do

Michael Metzger

not the enroll. only we'll cohorts. months -- them into is XX patients, on out course, design, started we've We this go of that the aligned but have, fair KMTXA, to only thanks agency as look for with over since NPMX a laid had previously the we NPMX three several we cohorts. disclosed XX our program. the and not we each spoken that statistics the number of patients patients about had our amount And we've question. the Yes, of interaction all And with had the

yes, new patients to use. guided It's the nothing we number So that still same really there. of had

Ashiq Mubarack

able where patient number? you XX you Are of provide any to are Okay. in the on clarity terms fitting

Michael Metzger

-- follow-up. yes, Only for that we've thanks half the to we've that guided year. of second Only the the

Sometime in you'll that]. the year, second we'll figure that to half be we've whereabouts the exactly with to able able and of out when there we are enrolled XX from be announce to like presenting [count

Ashiq Mubarack

Okay. Got it. on maybe more And one axatilimab.

For be you with the starting maybe color in about we such later combinability? which axatilimab the or how quarter, Is you're frontline trial potential ruxolitinib, of as the can any combo combined share this example. on for liver for maybe enzymes, maybe of overlapping there thinking with pneumonia toxicities should terms ability ruxolitinib,

Michael Metzger

they'll I if first Thanks have be later I'll guidance toxicities. overlapping the off. trial out, the this we're breaks, And kicking I Incyte's quarter particular, that question, to address could is for maybe combination And all a forward the think address I didn't in Maybe but is, the looking trial -- Briggs just and this we the trial Ashiq. target? specify you think year, it's overlapping the point think to

Dr. Briggs Morrison

combine that least axatilimab Yes. of us each of Incyte part combinations going Look, to we you of that, that. was at the would the on of trial, if keen But of toxicities that I get characterize think with interest they we look the to of agents. because is that into is initial at can course, wanting purpose agent, would of be both monotherapy they phase doses look full But the well. partner like and quite quite the optimistic

Operator

with Stifel. from comes Brad question next Our Canino

Brad Canino

can This AUGMENT-XXX. on It I get Brad. sound of is doesn't out you more like

maybe you're I'll we data ask the that expect the I for about SIP the the of this Revu [clinical year? framework] of Should inhibitor disclosure the multiple strength. Phase So from status around doing doses

Michael Metzger

the for Brad, question. thanks

of filing, that we've As pointed trial data think, your disclose supportive particular would is that our and these -- supportive I this a question, potential to supportive trials filing don't when out piece trial. ongoing. think for these from necessarily work are or are we is you, in I guided Revumenib

be -- don't we pieces there we I may in will particular comes that time thanks line for out might think related disclose disclose that there's But filing when ultimate there this, -- data. to related the But any be particular study. to of question. I the data think we certain when

Brad Canino

one clinical there it's for Does then SIP? any And what exciting maybe of Revu to get can Or component, strong then physicians ven/aza in practice for Or that, is set XXX dose the part because dosing? used escalation schedule some the there? continuous taking data it is schedule used discuss for the Revu combo? now? being the on combo And in I that use the year. mg it require then? shortened that's AML often expectations Is safety you on Okay. the a for Beat the all to dose this guess data can

Michael Metzger

I'll very Briggs Maybe Brad, of address question. Yes, let both good those.

Dr. Briggs Morrison

Yes.

the the the So was standard if a there on needed, But labeled revimenib. then everybody to regimen. there Veneza-labeled with to a escalation starting the strong inhibitor. are Obviously, is request interruptions, protocol-specified but is is component dose And regimen. dose start

Operator

Lawson Peter from comes with question Barclays. Next

Peter Lawson

how just got any is guess I update And enrollment around just a then NPMX, proceeding there? I've question axatilimab. around on

Michael Metzger

Peter. Thanks, is It's for Thanks NPMX well. going well the as is going enrollment KMTXA well. question.

certainly with the us really the that So have to at saw ASH, both there's would related data I really have it's -- say since they enthusiasm that meeting. engaged and I great think they're investigators

is going well. NPMX enrollment so And

complete relates this think follow-up. our the I to of second a half to had in and -- year. ability there's So that you enrollment And then

Peter Lawson

How your with Kind ultimately agent revenues? with single gauge agent launch. a look about peak that whether just how Yes, own combination regimen? is at that Rezurock and do just of think this we Sanofi's around or you should axatilamab, think potential And you launches?

Michael Metzger

questions, the Peter. for Thanks

I my look, you has I Rezurock $XXX drug -- And think So, impressive sales is million the far action, and impressive. in access sales, remarks, mechanism think we heard yes, in to we It's in is here first has relapsed/refractory different in year think setting. well. host a patients chronic in results versus of done our $XXX graft to the -- trials. thus clinical This upwards of its disease million opportunity

there patients think of therapies, through over to cycle these multiple they therapies. -- their I course different they tend the tend treatment to journey, get

opportunity, is meaningful Jakafi third our up experience share. the think, so line, in And pick and/or the what to Rezurock ability we

potentially. -- Ultimately, the combinations. drug well monotherapy itself action and this is opportunity not extends -- is for here of own of its just into but combination beyond -- But Jakafi. our opportunity Rezurock monotherapy has the overlapping as with that's potential ultimately, mechanism

that's And that's expand the frontline think in so Rezurock the could really steroids, reason the -- beyond reduce the which drug even to the as pointed first relapsed/refractory it in being I of of why in has potentially shown use year. out, this so and combine able Briggs about what excited setting use we're the

harder, sales If little potentially you $XXX to very $XXX million, a million year be a that's first to think about opportunity. to showing that large

just disease. that's Again, in relapsed/refractory third-line-plus

really in Peter? think, get treatment And think to so your the there something well earlier I patients journey, to for our combination I drug. was and pretends the in question, their opportunity go And else

Operator

B. with Securities. our And Kalpit Riley Patel comes question next from

Kalpit Patel

Yes.

well. the You cohort mentioned NPMX enrollment going that the is for

trials versus So Is these differences the the a Just understand trying I'm when gap started cohort. KMTXAr timing function just just of that the enrolling? there. curious about to

Michael Metzger

quickly do our the to strategy KMTXA -- have KMTXA. may with the BTD both -- enthusiasm physician with Look, I enrollment of more Thanks, for Good question. slightly think and and the cohorts, are I NPMX ability our combine filing as Yes. do for to kind pleased advantage move sort ability to something has and to we KMTXA. more said, Kalpit. its for with that of

that's of think it. part So I

The NPMX may with competition KMTXA, a probably And patients part in for drawing is that it patients our little there's other of competitors. less various be more studies.

do will we well. that I well quickly I think market that to competing for we're So and think can bring approved here. there we NPMX getting we some as us NPMX, get behind here, contributing some factors as that data are KMTXA as But feel advantage hopefully doing quite factors and as ultimately, greatly with with

Kalpit Patel

Has dosing studies. the the one commenced question then Beat maybe for study. Okay. combo the AML And on

just I year. think this you stated expecting that safety we're

just wondering those if So things I yet. started was

Michael Metzger

Kalpit. question, the for you Thank Yes.

So have yes, studies the combination initiated.

the trial as is So is also well both so as enrolling that there AUGMENT-XXX has again, the patients Beat AML they combination the chemo enrolling that -- start. been patients,

Operator

comes question with BTIG. Hazlett from next our And Bert

Bert Hazlett

for Just Just that regulatory the just indication a me. Is how strategy you're as Revumenib just Could you a publication one strategy? thinking you -- Or regulatory that post-transplant? frame about could there or listing you what about consideration from thinking remind are a two or or companion perspective? an there?

Michael Metzger

please? Bert, want that Sure. Briggs, from question do you to take

Dr. Briggs Morrison

Yes.

trials, Bert, pivotal on if go the Revumenib. -- to Revumenib to can on So indication don't go be they pivotal to we go in describe Best-case the allow have after conducted. trial, ongoing that we in work patients label they trial back we to response a back their a able might anticipate the in label That for transplant, the is, was scenario that. how

up us be regarding trial publications. out the So maintenance. for but does I a It mostly a won't handling there pivotal in we're road, down potentially that the think community through claim maintenance information be set way the it the will trial formal into gotten

Bert Hazlett

you've recently. Okay. which is That's co-promote your corporate And to a are thinking helpful. just in then and you decision? particular option that needs executed back How from there, a about believe perspective, gears of there Commercial Head I on relatively have timing a shifting that be hired axatilimab, a part? you And to

Michael Metzger

Thanks for the question. question. Good

correct. You're

proximity with include axatilimab. Incyte in on a That to option made co-promotion agreement Our does is filing. election

months have something end to that the closer understand of get before a time as is the we'll said to the it kind we bit that we we'll closer filing, coming Obviously, year. point. people let little have and a in So as better of

have actively top So filing just described timing, in another we I of and would both as two that it. say programs we about we're thinking you of really on that, terms that then are know, approval. for as today, one

are so some the And synergy we how the being opportunities, not doctors of products. called in that are on these commercial and same, the while may promote -- terms have

what sense the and that and with thinking the thought option co-promotion Revumenib very about nice whether that synergy potentially between for axatilimab, makes be we there us. So could some so actively do we're

Bert Hazlett

thoughts like but And on infrastructure, maybe things any sales sizing, know I that? Okay. force early,

Michael Metzger

commercial meaning I longer a conversation. effort, are a this It's is populations. not say that that we Sure. focused would -- patient large these very

number by physicians. of covered reasonably are focused a they importantly, More

field those we're time the the of We'll launch the be engaged we bringing force so XX XX in is to organization both ready refine some for it to reps. that physicians the cover Company somewhere to in leadership to order in give order these to to looks start XX in for are products. like And XX actively but of in what -- estimates color and more to building,

Operator

Beatty question next from with Our Baird. comes Joel

Joel Beatty

cohort a anticipate just on pool AML one the KMTXA there label? be Do breakdown just pooled also cohort. First you be and label? for the efficacy Or of on presented the ALL the on will the could that

Michael Metzger

Yes, question. great Joel,

that they'll I we'll patients to a strategy The asked another be think pooling that was sort or number that the alluded was of question presenting of part for -- be of is and earlier. total analyzed.

the have of we'll that I all look the is on the part package. think done that essentially, will of analysis, agency think subsets, of But pooled that, be patient. the a primary a -- will breakdown analysis be course, and the I our will and at

Joel Beatty

looks R&D be like a you a the because that on course over we'll ramp of selling? anticipate that priorities And Okay. accounts will part increase XXXX, then it question any of up

Keith Goldan

that Yes, Joel, one. I'll this Keith. is take

out his towards So Michael XXXX laid a go initiatives the in increase in that lot the of comments. will

full pretty full work recognize We focused cetera. all potential, needed again, to, to for the upon have realize Michael of programs line potential, obviously. are combos, expand you relapsed/refractory, But development heard current in going the the maintenance the looking et therapy, a Revumenib expansive program forward, front pivotal

a to formulation of to have anticipation expenses formulation year-end XXXX, CMC/tickoff a but ready solid in an filing as liquid only for tablet and market, Remember, will in in do well. not manufactured. we'll we that increase a our Additionally, be launch be be batches also there by to bringing registration get

the the majority of So increase. that's

Operator

time. Michael further Metzger remarks. this no questions at any have for we appears or additional It I'll to turn the closing program back

Michael Metzger

few seeing you forward operator. Barclays you, Thank weeks look Conferences in Cowen and Thank of all. next March. you the the Great. Healthcare to many in at We

I you you. all that, with wish Thank night. And good

Operator

you today's you and participation your disconnect may for time. conclude Thank at program. does any This

Syndax Pharmaceuticals (SNDX) 28 Feb 232022 Q4 Earnings call transcript