Earnings call transcript Q2 2023

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Operator

Good day, everyone, and welcome to the Syndax Second Quarter 2023 Earnings 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. Please go ahead.

Sharon Klahre

Thank you, Operator. all second us operating quarter you review for results. thank Syndax's of XXXX and for today joining a Welcome, financial and an Michael Metzger, I'm afternoon Executive Officer; progress with and Chief discuss update provide and are Sharon Company's on results me financial Dr. the Klahre, to this Goldan, Gallagher, Neil Keith and Officer. of Head Financial President and R&D; Chief joining Dr. us session question-and-answer are on Also the the call today for Scientific Officer; and Chief Ordentlich, Peter Dr. Anjali Business Ganguli, Officer. Chief

of accompanied is on a slide Company's has that posted page by deck the been Investors This the website. call

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

XXXX. any of in we made not from materially like Before various discussed be meaning the Reform result I'd to by Actual begin, indicated considered Factors those those of Private are this remind forward-looking statements important are results you that may as on the as that be within the including Risk Company's a the on statements our the in section today, on the SEC. views Litigation this its Any only. of record replay statements call as differ available www.syndax.com call with statements factors, these to during Securities this historical August may of of XX-Q, most website, other be will forward-looking represent A of a Quarterly will Report reports following filed XXXX, the X, -- Form call well recent Company's as available completion. Act

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

Michael Metzger

you Thank all joining you, for Sharon, and the thank webcast.

time Syndax. for is transformational a This

biopharmaceutical us becoming and which executing potentially excellent priorities, making milestones on a company all path best-in-class two put progress products. are a We with to corporate commercial stage our of on

positive strategy a We started full AGAVE-XXX continued data AGAVE-XXX at axatilimab second reported future our chronic to dataset meeting. on the quarter and in of recently presenting look position quarter, third the deliver to a great in medical forward graft-versus-host the Throughout pivotal disease. we having off we development

revumenib leukemia X, to our Further, the expect we to add this the acute in Slide reporting believe which trials proposition meaningfully on its see profile. can of of are year-end, to data and value from revumenib forward by could support of from quarter. of later several population trial KMTXA you As its we data best-in-class looking have we AUGMENT-XXX

we filings as will launch revumenib Once a from in have data both both submit axatilimab with and to by XXXX. hand, pivotal if company and the cap unique year-end very approved potential in drugs opportunity regulatory position smid two Syndax a be in

$XXX not to of million and development amount business have June our of on trials as we expand also core but pursue out indications launches our planned beyond enables and This us and We selectively are registration cash in funded the equivalents laid with X, XX. cash well opportunities. only Slide funds commercial

strategy. oncology stage value opportunity We future and our continue conveyed a long-term add to previously new compounds need have differentiated but any with to transaction targeted corporate earlier bar our create consummating align high to as our we is be to substantial pipeline, evaluate to would as for

X Slide our to to dive turn revumenib selective menin inhibitor. now Let's into highly

in patients mutant trial is leukemia AUGMENT-XXX with revumenib acute pivotal ongoing. NPMX Our rearranged KMTXA evaluating or relapsed/refractory

basis by which AUGMENT-XXX regulatory -- to for year-end. quarter expect pivotal rearranged the leukemia filing to continue from in serve patients in could from as year, this KMTXA data of U.S. acute We report a third the the trial the

Patients relapse. one safety. ALL, maintenance of risk response, KMTXA engraftment, these patients, primary month a CR/CRH The trials with an of patients following that and continue is of important designed patient survival CR/CRH AUGMENT-XXX have could X revumenib is older. was The who for which These given opportunity undergo NPMX the secondary enrolling transfusion, populations portion mutant successful KMTXA that -- or Each pivotal transplant endpoints at including include patients they single as rearranged of percentage populations durability Phase of enroll AML. endpoint AML, high rearranged are option distinct independently. these trial independence, these arm be of three the with age treatment and achieving to overall with that each

is As Phase compelling have in to for the reminder, we two patients X remain years, revumenib's treatment response profile. nearly tolerability and and safety a experience, on had in due which possible

single relapsed/refractory AML acute acute from subsequent in NDA a reached ALL agreement we filing with leukemia with December received and the cohorts XXXX, conversations treat FDA, an all data adult we into rearrangement. at leukemia to As a patients therapy rearranged whereby of will previously In covering breakthrough aimed designation a the reported indication subset KMTXA generated KMTXA pediatric we and patients. pool KMTXA

We the in by population expect quarter relapsed/refractory adult pediatric this patients an of to and end NDA provide KMTXA data file to and for this top-line XXXX.

and goal release will all safety so endpoints meeting. interest. for preserving while enough secondary that data likely include of efficacy medical for profile data will drug the stakeholders at Our enough primary of the provide details top-line with top-line the The along understand presentation on the still future be disclosure a to endpoint

to we expect of by this relapsed/refractory patients mutant cohort continue of year-end. Separately, enroll and NPMX completion AML enrollment

field, first-in-class published revumenib landscape X highlighted compelling on a and Nature competitive the in a experience treatment. experts As be revumenib's X, profile not we in with but look to demonstrated believe also March in engage clinical the best-in-class only at we and as Slide Phase robust the in physicians

and at MRD demonstrated median the a XX% with outcomes received data was the NPMX CR/CRH As a in Experts of a point transplant. that negative X associated in rate the four marrow RPXD who patients AUGMENT-XXX median the among duration in field with achieving of patients a of reminder, X.X to the both XX% therapies, months. prior MRD subsets is response of rate Phase KMTXA CR/CRH the bone also negativity curative of since potential high improved

and this patients option in went of to thus revumenib on the of While the several pivotal therapy maintenance portion these setting designed included Phase the trial at AUGMENT-XXX compassionate for X transplantation, re-treatment we use treating in request of physicians. trial the wasn't receive the following the

backbone believe and acute X. revumenib safety has could with combinations for that therapies. Based We rearrangement clinical Slide with Turning KMTXA refractory post-transplant of NPMX profile, expanded patients and beyond the leukemias. efficacy into setting become relapsed our the including compelling maintenance to on settings strategy mutant revumenib's and treatment earlier and approved

generation acute trials leading benefits of addition the that and various is working seen evidence accelerate are clinical NPMX KMTXA with with of groups settings revumenib clinical In leukemias. to to conducting, we Syndax investigators the and further across cooperative of

Enrollment BEAT-AML Revumenib is to and you. trial. to being for minute unfit as by XXXX. the receive is and patients chemotherapy a these to the Phase the part expect with and to treat VENCLEXTA Starting Lymphoma potential ongoing are Leukemia combined with take me on our Society. we continue induction year-end Let from safety trial highlight X diagnosed azacitidine for at AML data with newly of the umbrella who collaboration RPXD a

The safety of AUGMENT-XXX with acute for the chemotherapies or is in salvage designed trial refractory relapsed patients revumenib to leukemias. assess with standard combination

MD hypomethylating relapsed/refractory revumenib combination We SAVE in expect year-end safety with to by XXXX. initial of from oral an oral leukemia INQOVI regimen, provide being trial Dr. an an all Cancer Anderson is RPXD acute -- update on The led the of agent Center. and VENCLEXTA all and trial interesting potential Issa data trial at the by and

by Australasian treatment. designed part MRD as and It Group. explore monotherapy trial disease enrolling INTERCEPT following of the patients maintenance trial is of master positive the the Leukemia clinical initial the AML Lymphoma revumenib to in have patients And activity with as led is who

plus trial maintenance three a patients initiate intensive to plan combination by monotherapy. standard also XXXX. of we acute This newly finally, for in trial will with revumenib's diagnosed care of And as revumenib option with known with an seven leukemia in include year-end chemotherapy

to XX,XXX to and is patients. we X significant more committed we currently leukemia or NPMX KMTXA There acute the potential area even settings. to encouraging Including of together leukemias, clinical unmet to an therapies address targeting XX% no are these across up Turning a . of bringing upwards population Slide are need the expansion patients opportunities, to approved represents NPMX see acute This patients. of that FDA various benefits and KMTXA AML

are metastatic are as would we tumors in tumors. treatment we as trial In the to through the enrolling cancer. colorectal clinical in this acute preclinical a signs interaction supporting also patient market X the and in of disease addition end, proof population. solid signal trial compelling menin-MLLX difficult concept To leukemia, seeking a that beta-catenin Phase or The proceeding driven escalation stable promising we in phase is on revumenib of exploring of view dose the based responses in role opportunity use

We X trial an update Phase progress the of expect to year-end XXXX. before on provide the

of recap pivotal ask, Neil? provide reported Neil, axatilimab. to brief I data will now our for recently a

Neil Gallagher

you, Thank Michael.

pivotal on Last beginning results receptor therapies. positive at tolerability CSF-X the for you efficacy, from that recap trial a joined targeting progressed safety, and two chronic the antibody monoclonal shared X. on disease of axatilimab week, after of I to as provide now prior in least GVHD active recent expect patients the XXX Moving we whose with axatilimab global I'll data call. the many Slide evaluating us had AGAVE-XXX brief

cycle All three one on well disease XXXX dose on cohorts stratified or and treated GVHD. as baseline Patients using ibrutinib, endpoint seven ruxolitinib of NIH then based criteria the belumosudil prior the response rate to consensus were exposure day overall chronic primary at for of progression. by AGAVE-XXX met as severity,

objective our X response months X the play were intermediate every recovery cycle codes, maintaining dose milligrams and The dose kilogram kilogram The dose to selected maintaining the regimen role rate kilogram of per per range milligram endpoint in and axatilimab. six potentially weeks. the or were in two were per in end of lower milligrams treatment physiological treatment. three of kilogram as macrophage Because events primary investigating that was or These thereby chosen X.XX population, milligrams these adverse to for four the FDA X.X every kilogram seven of received one who was Phase the to time by robust trial of AGAVE-XXX consultation trial every one observed The explored a randomized different trial, by an X patients minimizing of weeks was an essential with but patients two weeks. day milligrams X.X responses X.X per per in represent homeostasis, each allow efficacy. macrophages

healthy proportional patients from volunteers. This on six option regimen. per doses a is X dose the in After switch the months trial Phase trial, previous at milligram all to at X.X per by X monthly kilogram data and PK/PD to once milligrams kilogram supported axatilimab a

primary Slide Turning response weeks, of trial to rather met overall was the pivotal trial. X. to reemphasize AGAVE-XXX The our of cohorts success the in rate overall the All excitement response around the endpoint I want three two rate. at patients treated every patients per treated every milligrams per milligrams and treated at four in in kilogram patients XX% XX% X X every XX% in kilogram X.X weeks. per milligram at weeks, two kilogram

greater While the given response that kilogram be not milligrams support belief doses yet rates, tolerability weeks as key these for and dose macrophage a exposure at analyzed well particularly recovery level. response two every relationships, between may improved as provide we opportunity doses to have data higher per our lower X.X

mentioned, responded lead response X.X well all. who trials. As rate data at symptom XX%. responses at one a seven discontinuation, common the adverse were the by was kilogram symptom modified prior patients cycle cut reduction still with with by most I were accompanied in on-target durable Moreover, by The the the level, of responding observed per reached dose rate of year. time median responses the axatilimab Axatilimab response scale. was not were burden effects a were XX% just duration milligram of were events that yet low the in one the with to observed consistent of and tolerated the as measured at day

were like heavily despite and patients of Slide was were study included advanced who the in that This the pretreated. It robust patients therapy. of approved that cross comparison and patients targeted prior very On ROCKstar is chronic these XX, highlight included similar more than received trial notable I'd efficacy that that more heavily AGAVE-XXX to fact advanced in of observed pivotal the shows of agents. pivotal a lines slide patients trial with a with more GVHD two or Rezurock population trials pretreated

could were trial more a number diagnosis, greater the if Patients there Jakafi. populations patient prior point points see, since Rezurock the which time trial results AGAVE-XXX bring believe a of had trial. median We axatilimab As therapy, these impressive patients including in and GVHD, to and the received the that the chronic the received AGAVE-XXX important can underscore between differences differentiation, of to of AGAVE-XXX value patients how ROCKstar are approved. that axatilimab significant more lines trial and had severe in you longer meaningful

back to the turn now Michael. call I'll

Michael Metzger

Thank you, Neil.

approximately patients unfortunately opportunity no beyond suffer disease XX due with XX% for second advanced We that progression, addressed the patients. GVHD, from chronic XX,XXX that population axatilimab. line estimate response treatment chronic or whom Slide aren't are disease cures details fully inadequate market There this current for GVHD require manifestations of of U.S. treatments. to

Following variety given though additional treated patients agent of may initial the with therapies. patients of experience cycled approved the the treatment of depend corticosteroids manifestations several be through address specific order used may they're may on a how therapies, which with with in a are the Essentially, physician's disease.

derived with for unique and key provide a moving prevent value to effective intervention there used in to underserved approved the only in concerns a launches is Rezurock commercial in speak the as treatment axatilimab offer of action no partner commercial unmet the chronic occurs. build this that that GVHD, suppress also adults mechanism action. proliferation to may could may could in of in differentiated, and terms axatilimab as translates believe Not the standard macrophage provide settings it comprehensive earlier of GVHD. large disease supports to Jakafi but are the and of advantage it We practice of treatment interactions overlapping to Axatilimab's ideal an currently currently before to as more this significant ex-U.S. organ and in GVHD a successful The pediatrics, chronic additional changing damage potentially mechanisms for monocyte both the therapies being for of opportunity. activation than need Axatilimab's the theoretic population. care of therapies. opportunity drug-drug of ability chronic markets Combinations expand well also and axatilimab combination control differentiator, earlier paradigm

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

Keith Goldan

Thank you, Michael.

XX, Let the quarter me for ended minutes XXXX. a financial take results June to few discuss our

quarter Turning our to of of to these in the year's the for and included our results in so are won't second them comparison quarter Slide operations XX, the remarks. release, I prior XXXX press repeat the

last our filed to on quarter are Form share per that quarter or like today which of and period for by in compared XXXX I loss $XX.X driven financial $X.XX loss second increase to employee-related Additional details $X.XX or was per loss available the within difference out net professional a second net expenses was share in R&D. report, earlier XX-Q. our point an was million largely comparable million for in our net the fees year. This and SG&A would both $XX.X

We second and and million and short equivalent XX.X pre-funded outstanding. with the warrants $XXX.X in and shares investments, quarter cash million ended long-term

the potential the appropriately the is our build into allows sheet balance provide to maximize XXXX, and pipeline. Our second quarter runway to us expected of which invest to value to of development pursue opportunities pipeline business

it in Importantly, organization commercial allow us stage will transition also a into XXXX. to

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

development million to third $XX to million this expect to million operating expenses $XX year, and $XX total the and be of GAAP to we research $XX expenses million. quarter For be

development continues compensation For approximately research $XXX million the of million expect to is to $XXX which and expense. be to full-year XXXX, total $XXX expenses operating million million stock of be inclusive to company million, to non-cash expenses $XX the and $XXX

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

Michael Metzger

Keith. Yes. Thank you,

what Before near-term, we highly we questions, presented to our on today. delivering quality opening to for I'd pipeline. readouts focused briefly remain the up like data summarize In

from the quarter. the this in pivotal are trial AUGMENT-XXX forward our looking next reporting KMTXA readout We to data population later

the drug in both potential candidates make have to setting U.S. which for XXXX potential We build will our share. by as care impact the data lead market patient filings for registrational a considerable of two on year-end expect basis significant pivotal serve and each

to encouraging capture to In lead our the addition, initial beyond value we in by even current into we so, In continue our bring to more of to patients indications. aim opportunities candidates expanding explore the doing ways need. benefits of the registration clinical maximum pipeline

coming been critical momentum with generating the and this in positive for horizon. months the milestones to has value we an continue It exciting Syndax year-to-date expect on

execute allow vision remain I that commercial that company. stage we on the and to to expertise goals our us a will resources on long-term have to successfully biopharmaceutical the and confident transition strategic

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

And with to call that, the Operator? I'd open for questions. like

Operator

[Operator Instructions].

TD today Phil comes ahead. question Please first Nadeau The go Cowen. from with

Phil Nadeau

questions afternoon. and progress. Good Thanks for us. couple A our taking congrats the on from

in upcoming response Is to lower the XX% order interval KMTXA disclosed has First the statistical cohort positive? in be that to that the technically or you on for a excluded the requirements below of rate cohort. be to there the be confidence pivotal for bound positive? the Have data data

Michael Metzger

for Thanks, the Yes. question. Phil first

nor not We lower rate. the have the target bound disclosed

haven't about. we So the statistics talked

is I XX% has our but that have that specific regulatory precedent XX% bar, the is for given and us, little lower end and AML guidance of the been XX%, the course between than bit guidance space people what's open done of target of on and lower And think guidance haven't people CR/CRH I the what about we an somewhere asked the obviously and has the is better approved in trial. of think sort we bound of what generally, which that a been look the have what question. at in

Phil Nadeau

are the a next repeated that? KMTXA do we use shouldn't think to is in likely why pivotal that the question year. be NPMX? NPMX Do data second there you investors population a in And on what will in is KMTXA a most show I be what think to assumption shown going proxy that for study, fair Great. the as reason Is you

Michael Metzger

Thanks for point same the I the think similar. looked estimate Phil. X data XX% was question, that was Yes. experience RPXD. the Phase at very The Look, the our

some that So would to rationale us. sense make

be I sure, so they to And think that would same. it's the think reasonable roughly

Phil Nadeau

says to end from us, the receive XXXX. by Great. there going that And BEAT-AML? release you is results the venue the about then plan question is press at of X the recommended in safety it you on a dose Phase the to Syndax will from last BEAT-AML, learn Do when which initial investors data disclose specific it, receive or

Michael Metzger

for have and BEAT-AML with close a group. we trial, question. that Thanks Phil, Yes. is the obviously so that trial group cooperative collaboration

look We will related for to committed haven't to a the to before we and will have that end some have expectation information safety the venue the we way what be that but at. appropriately will done communicate and we of RPXD the year, that

Operator

The ahead. Rama with comes go next JPMorgan. Anupam Please from question

Anupam Rama

so updates. thanks guys, much and and the two Maybe congrats look forward question upcoming on from to progress the for Hey the me. taking quick ones

the on levers sort your market here as opening and analysis the insights thinking key Michael, the could in much. the year think Thanks what year, in some later that you can of underappreciated profile of following-up on about what data, is then, you kind you're additional market? maybe axatilimab? AGAVE-XXX about presenting So of do terms us And missing provide the later the this of axatilimab? so full of emerging what potential update of on Street we are think comments remind the

Michael Metzger

Anupam. Thanks, Great.

the I'll and question So maybe cover update related to AGAVE-XXX please. full ask first Neil maybe trial the to that, the

Neil Gallagher

Michael, and Thanks, thanks for question. the Sure.

organ instance, affected. added for disease response not by have rates we that disclose, So graft by

therapy, instance, the there We we concerning given haven't think rate, although anything prior in signed we that by extent disclosed prior response rates yet. of there -- that that we response in therapy high disclosed we haven't don't haven't would overall -- for that be that think the

we mentioned, perform as as plan, analysis haven't I our exposure the yet. And response

in be We future. expect all a the to that meeting of do at able to

whatever -- be that that use could data we discussion to on have community, and their the hand of will in so. and top that, obviously to partner So dispose prescribing we of with

Michael Metzger

that. question and I'll second market to presented Anjali ask thus was And what to maybe be related we potential far. Right. may relative maybe market to the missing And what Anupam the address

Anjali Ganguli

Okay. Anupam. Michael. Thanks, Thanks,

and at I XX,XXX estimate the least prepared current said have population about the axatilimab. GVHD advance patients Michael the with living for his them the to we've we will As a is in in today. that said U.S. think what and and And trial for in setting chronic believe line remarks, XX% to expect AGAVE-XXX label there's of we a was We enrolled third beyond.

top-line a patients exposure. seen And Rezurock with is GVHD and what to very over refractory in showed real current we that chronic in mimics of week prior I the think treatment had population ibrutinib release world patients is and which prior paradigm these XX% had last XX% effective axatilimab the XX% and in rux,

multiple So time at diagnosis X.X product extremely was drug especially tolerable, low of despite of and discontinuations. GVHD the enrolling a rate dose since mg/kg with severe the a very population therapies, with chronic very extensive

from for we we but important about this The deliver and macrophages axatilimab for AGAVE treating talked treatment The GVHD. patients. pathways a exact dataset what cytokines on be tool about effects as meaningful disease option profile as and and for fulsome its excited that about are to gives differentiated durable, as more to targeting us monocytes patients differentiation provide just signaling is know a and to axatilimab, Neil for modifying axatilimab potential versus have eager confidence are mechanism know and physicians based their seen very the refractory will provide an and likely

to profiles And brings on know value we'll to working promise can that even but trial effect over and disease modifying there's axatilimab combinability to extend and we these deliver enables be a patients. we patients. safer that said, time, be to its today, Michael its and generating going as antibody that And significant think data earlier

Michael Metzger

Anupam? else, Anything

Anupam Rama

for questions. taking our much so Thanks

Michael Metzger

Yes. Thank you.

Operator

Please Nochomovitz from question next Citi. comes with ahead. The go Yigal

Ashiq Mubarack

if the by Mubarack duration on like questions. median top-line CR/CRH Ashiq we'll a cohort Thanks response? type is for data this a upcoming of sounds be include Yigal. of but for my taking will curious the It get a for data, I'm get at will release the the team, importantly, Thanks. and KMTXA more we'll breakdown more Hi look leukemia and release top-line

Michael Metzger

Yes. Thanks the question. for

I look, goal to be here the information I of provide in think So stakeholders our can the There profile understand physicians said drug. is top-line. in as such really included top-line will information in meaningful that the the and remarks, provide, my that is not

I we and and think think this see, be will And I are provide possible primary as but the endpoint in of attuned being are it's set provided, duration to say hard part we'll point to that that, much hope people to be the pretty what to as release. likely your that looking but age -- know what to we're beyond at top-line.

Ashiq Mubarack

your just in Thanks. I'm sort we Okay. for drove year of of OpEx maybe sort operating quarter. should rest I second like you full-year spend is if the about lower the thinking were the of particular end understand. seem Maybe question. that the the and spent for I'm and less guiding of than wondering just be how should if on assuming anything one guidance we be range. unchanged. you does It curious given

Michael Metzger

Keith ask the Thanks to that. question. I'll address Yes. for

Keith Goldan

Yes.

regarding not Yigal. Yigal second So -- quarter I'm the sorry,

that timing primarily spoke that second -- on some spending the it the to there's quarter, issue. CMC call timely in manufacturing press remarks release lower Regarding was the Q in and

us how a the in in commented spend in Q was under of come expense guidance. led lower the to that So the to which part we quarter, second R&D contributor in

come full-year guidance With to full-year, I did the OpEx for just not further make beyond for look and yes, that. -- under, quarter in we respect comments but reaffirming to that appreciate and on question the your to in, R&D us going the would

Operator

Canino question ahead. Stifel. Brad with Please comes next The from go

Brad Canino

afternoon. Good

data you've gather after the think and to top-line talked post-transplant your about revenue information. time release And take to important this transplant be that remarks, after it's As the durability will number those in going restarts quarter. I

the rates your the interim, learned those the you've So how that get therapies? in have restarted world setting, of you. diligence long real in they of on what and stay specifically in the done in that setting, inhibitors, you Thank relapsed/refractory terms about as patients proportion of and IDH FLTX the in post-transplant

Michael Metzger

Yes. Brad thanks for the question.

ask Let on that comment Anjali that, to me question.

Anjali Ganguli

Thanks Sure. Yes. Brad.

IDH between had the So relapsed/refractory the weren't rates, I I many back patients. nor difference the think and neither -- that's to meaningful go, inhibitors had in patients inhibitors actually where opportunity transplant so benefit so prolonged the treatment FLTX the revumenib the setting, would on profile that go extend differentiated And duration molecule think our bringing very for to opportunity really and a these and is therapy. there

Brad Canino

just on question clarification. And maybe Okay. another

safety given you a the safety? focus does imply should data? mean For receive mean of that it's the the that BEAT-AML to and believe triplet, X Phase be when or will that you say imply data on you not RPXD, it drug activity Or does

Michael Metzger

it's for Thanks I think the Yes. Brad, latter. question. the

the to pretty focus obviously X RRXD, what always dose we X think through to is right? were So is to we We're Phase on I on that experience this before -- dose is goal Phase an the inform get escalation, trying so get end we're escalation consistent a saying trial, in the and hope in of year. trying the to and safety.

Brad Canino

Yes.

results MRD I negativity. X triplets, conversations investor Okay. FLTX XX% have of rates like IDH CRs where plus that reference those But and Phase the were high do several

And other triplet are try comps your stage? we would at I for to suggest think from to data? think about So want as this what we know precedent to caveats you about right the these those you, compare

Anjali Ganguli

Yes.

tricky and effective onto see beyond. adding an meaningful going it's you're population with I above I patient already you're a to -- think to Brad, be small when really mean, therapy differences

is in of So obviously a plays waiting benefit handful out a going to whether patients, exactly what the it where we're think enhancements see. triplet, but there's are I we the be to from think

Michael Metzger

Yes.

a think they're lot add patients, or on are to just to line to -- what not I to but these we of saying, again late think caution early Anjali I they're need Anjali patients everyone sorry, them. was

side. So much we're assume on efficacy not to the too going

I think but an how efficacy, obviously and this see can we'll if on that's intent meaningful. again drugs RPXD more the we're is get to combine -- is we

Operator

question Guggenheim. ahead. Michael with Please comes from go next Schmidt The

Michael Schmidt

guys, Hey same thanks lines. along questions. follow-ups the had for taking a I my few

So -- KMTXA cohort, that percentage subsequent And in cohort pivotal the of patients in terms the and receiving about just pivotal maintenance study. DOR to of the transplant Phase your the thinking AUGMENT-XXX in study. I'm in in similar the in X is

Michael Metzger

question, for Michael. the Right. Thanks

Phase X, part just post-transplant. reminder, was we of have on not the So drug so a the in didn't That back protocol. going patients

one the X, measuring changes AUGMENT obviously, between back therapy a the Phase the for and able is of account on relapsed. were that we until of go duration trial Phase duration therapy, fact on patients post-engraftment, patients it of meaning that you Phase go, major goes in portion is treatment have to So change. really X the -- X measure how patients will you're that when major And stay so long

So it's whether -- to not And they that's or really measure that go transplant. the includes measure.

continue therapy. time censored on they're So one the of of transplant, at it's if as they're they not line

revumenib. and on retreated some be transplanted continue track get be patients there'll And therapy will who stay and obviously as There'll and patients transplant and patients well. and get on there'll get progress. receive get then revumenib those don't transplant and and who retreated who be with So don't get then with treatment then

the the all fact and enabled in Phase patients they're go that some maintenance. as treatment say by experiences back treated be able of those different X, be on would I to there'll So

Michael Schmidt

they with in efficacy Thanks. different efficacy the FLTX is other some given Understood. KMTXA question, than subset then bar, mutations the the hurdle it. the -- overlap subset regarding the is for available? And my are relapsed/refractory Got question and in are IDH AML treatments in hurdle the mNPMX regulatory

Michael Metzger

Thanks the question, Yes. for Michael.

course, -- the there for that hurdle KMTXA to approved are really think get patients, or specifically for line with that either likely would they of comment this our drugs be their the at the refractory stage fourth I there view that, of fifth is disease; I once approval make setting. no rate similar. NPMX to are relapsed/refractory in is

same the cohorts of each individual in number of Now we trial, have the again, them. provided patients haven't of they statistics but our the are do

in So set our that you statistics give should are same the up understanding some way. that

thing. regulatory think construction maybe is of something do precedent And So from our again, trials AML well. as you can in I one the

Michael Schmidt

then guess, of safety you that advance end of early I And into view BEAT-AML you what or study? on would you as of constellation would for order acceptable Is see this in or data, of upper rate the acceptable? that of data lastly, example, Super. a there the safety events registration frequency Okay. the next as particular what adverse profile in type to so what's if view year some later safety this thrombocytopenia,

Michael Metzger

Yes. Thanks that last for question.

totality say to So stage the tolerability the this this disclosed at and sort and actually is going priority at have one I important how a data combine. just really will particular be be understand looking would we've of not side really, before we looking obviously anything, these We're safety for we data before effect. of the to and any drugs

nicely. combine in think our we drugs should the mind think I

that looks so have time overall present profile see And like we'll at what data. to the the we the

Operator

next Lawson question Please comes ahead. The Barclays. with Peter go from

Peter Lawson

so Great. Thanks much.

GVHD starts we side and dataset you expect between of kind there's what things, event. Rezurock. if of should on when around focused emerging we it's kind that there, differentiation around of of that's follow-up of the again the if just the And kind should full if ASH be the an to Just kind dataset

Michael Metzger

you, for Yes. the Yes. Thanks question. Thank Peter.

presented what So is did target. say be tend we we of dataset without exact our exact is to before year haven't at, giving meetings, the end meeting away the not that what -- because we but disclosed likely

I that'll And about additional information be. and so think of question follow-up where to maybe I'll that's on ask an And differentiation. then Neil the indicator probably

Neil Gallagher

yet Well, the that I that to data get medical we be for we -- included. would at already pointed question. we across will when Thanks for anticipate fact disease haven't the presenting that meeting, I And those responses organ to disclosed classes. a Yes. instance would affected data

that population those Just heavily to during prepared agents. prior in presentation, pivotal AGAVE-XXX the the remarks patients recap, included and study more and pretreated heavily was with more in as we and than included to the severe the studies really alluded was approved the

of six mg/kg And information result rate insight only medical particularly you expect be relevant as that but So partner of a could that as data X.X include I discontinuation, disclosed said the adverse number effort and data at and terms points, the of every of that therapies, I to of can disclosure to all community reiterate would data events. the with patient. to of from weekly safety on disease also we've the helpful discontinued time patients you but as mentioned, we'll a prior think QX I've low I all in the more the extensive won't I meeting. our we're diagnosis And make point already the severity, particularly

Peter Lawson

should And on to side is when I you. approval the that and kind guess before we the expect XXXX, story, see Thank in a after of filing Great. AML? potential then for of in the or that kind NPMX of data just KMTXA

Michael Metzger

question, Thanks Yes. Peter. for the

NPMX, So -- guidance our we XXXX. is

part question? this point. at terms I'm that narrowed the in sorry, haven't And your of of -- second We what

Peter Lawson

kind after comes or of down filing whether the that, KMTXA. If it of trying potential it actually, to narrow before

Michael Metzger

course. Right, of

So yes, we one close But -- looks KMTXA would get course, say it's actually drug timing to that's that the a answer for then like. we'll because filed what of see relatively to proximity. in it's have I difficult and to have

Peter Lawson

Okay.

that the Sorry. And in proximity be that, close that, of around approval in would KMTXA.

Michael Metzger

understanding, of apart. the don't will our far be best be sometime yes, XXXX. To there'll both in We -- it'll think happen too

Peter Lawson

back queue. Brilliant. into the Thanks get I'll Thank much. so you.

Michael Metzger

Thanks, Peter.

Operator

from ahead. The next Riley Securities. question Patel go comes B. Please with Kalpit

William Wood

you Hi, for Thank our questions. taking this William Wood on is Kalpit. for

strategically, label? Just alignment will or advantage axatilimab on think the one it's for and one doses GVHD, Quick expect on dose to regimens should from just filed follow-up be dose us. what for for for or file an there when do multiple on actually best dosing is your we you

Michael Metzger

William. you, Thank

Let me ask Neil to please your comment questions. on both that on of

Neil Gallagher

agreement the across let well, me by I saying three So to we're the doses. start currently analyses obviously, as conducting just I risk benefit all and assess mentioned, as additional --

which at two We or be we've efficacy excellent. to doses profile would we discussed milligram the on is milligrams agency. file X that one of or seen you've X.X can't with the in because observed and that X.X As comment are would safety whether we're mg/kg pretty dose has file dose we the The similar.

to but dose. think the I to as -- our that that's be the the subject that be regulatory optimal and will objective But us dose, FDA. leading efforts insight discussion file as would insight the potential be recommended between between recommended would dose the well, actually

William Wood

Thank you I color. have. That's for all that

Michael Metzger

there going was ask, your just was I question? of Yes. second part a to

William Wood

Mike. it. it. No. appreciate That's you, I Thank

Michael Metzger

thank Well, Okay. you.

Neil Gallagher

you. Thank

Operator

from BTIG. ahead. Justin Zelin go question comes with Please Next

Justin Zelin

of taking Hi, the just a just the thanks duration for here. congrats one, the questions question Maybe on on about and AUGMENT-XXX earlier response. progress Michael's clarification just

going that correct? So data, on not we gone inclusive of when correct? see assume Is who patients that received whether not. be they've transplant, by out broken that's should It's have that is we transplant to or

Michael Metzger

transplant. patients the have for mean, It's early per and that a to gone but say patient the on how say se. that include I patients that to at thanks looking Justin question. data would experience overall probably will present who we will that I little the we're

those duration, so the we calcul would would if as calculation I And we're in expect -- patients that that reporting include well.

be this in little -- remark, are in a -- mean patients speculating. duration if trial, assessment. said we'll that be I the be breaking haven't I'm just bit including included saying naturally the maybe we I out. that in what would will then exactly haven't those I'm I So just they

Justin Zelin

Got it.

setting, to you talked the the in I'm sense or seven it's too here And to if INTERCEPT market. that. combination you've study say see naturally, about plus me. Okay. when three from early setting just data That either the maintenance might curious study large the is the or makes maintenance if

Michael Metzger

Yes.

beginning around a how time, say three to this little probably think that will is -- things trial, little to a we running end the going before trial early. up to And say had cooperative little the get of the year. and group I would think said a try in for detail bit year INTERCEPT We'll and that. a it have we're in is is of put early we a just progressing And early ongoing. to XX the little take in are so which finer I plus just XXXX, seven more

Justin Zelin

data. That makes sense also on me. And very positive to congrats the axatilimab

if on formulation there you for or could that when might you subcutaneous curious if being comment Just formulation studies. any clinical have we see ready the updates

Michael Metzger

nicely. SubQ for Thanks follow-up. the is The progressing Yes.

bring that I both the Insight are and to in tandem forward and Syndax think are progressing. working

take we tuned doses option potential file bring we here, a put the that we nice little or it's a yes, alongside as could We haven't bit forward. Again, around stay get a timeline just yet. dose closer we think that but that

Justin Zelin

Great. to forward taking questions. Well, Congrats my thanks data. for looking I'm the once again.

Michael Metzger

it. appreciate Really Justin. you, Thank

Operator

Farmer The next George Please go ahead. with question comes Scotiabank. from

Unidentified Analyst

Hi, George Chloe good afternoon. It’s Farmer. on for [ph]

Just two from us.

The first on AML.

reasoning you're the be what to you in approval Insight. behind contribution And NPMX question of do So think giving other? both competitors AML in just your Can and/or about far, come an with to you dominating and you on the comments versus assuming effort that. confidence your your like to more so about higher share data of as will I'd data know along to commercial on ones And set AML your speak positioned level well. the KMTXAr axatilimab and the is penetrating market the second

Michael Metzger

questions. for the so Great. much Thank you

KMTXA we AML first and So and think first this and us indication And market of apparent the well. what's to ALL I best-in-class. least, at be will think approved to -- first be believe first I first in we'll patients. extends that menin to we'll And think as many the there look, for think NPMX all, to space and approved I that inhibitor drug is we I be will

best-in-class profile. the market we think have I and a first reach we'll believe

thus execution So presented vantage get confident lead front Phase that X sets the we really this to done in far. presented top a fact I at align data we in and And I robust feel ASH from be nicely very can the see would we our of that field. based point, us very data set the think that really and it contender up us on

how there that's of that's so out And today, we as otherwise, really data a revumenib. we there's -- of that lot suggest would So feel. not

of participate, or quarter with be have arrangement an our commercial the that participate making with and to that two. option up commercialization With we will of up is that's to an set the election axatilimab Insight the our we axatilimab, And in effort. next we over XX% can

it's -- there relatively pretty talked we about, that us because are very soon, coming have drugs a election. call And interesting two commercially to at similar make setup we time. point. same So we'll market it's It's overlapping the as an for much

could on drugs. calling be detailed be will with that physicians both So

opportunity, commercial we So it's advantage our for very size, look of. meaningful a would small it take which provides a company to

with an that So next and done was but it make this few provide does we'll the election us quarters, in purpose transaction with doing to Insight. again, that's in advantage it an

Unidentified Analyst

the Got follow-up you. what And some there key into are are account? it. decisions? drivers the quick just some a the you'll of Thank of factors these that So behind what take

Michael Metzger

consider key did are What to would Why hear I us? commercial for drivers -- correctly? for the your launch question

Unidentified Analyst

Yes.

decision. factors take of So key making before election the you'll that account some into

Michael Metzger

no for the a there's that. profit It's difference the for think down economics for it I Thanks Well, XX:XX Yes. us. comes to in U.S. in us split

So provide we contributing or commercialization we the regardless whether reps of not. to of cost are

a us is for have efficient on that and sales be reps setup both an -- calling in As the products will products. physicians we both for same I mentioned, it

So there's overlap there.

certainly, of our how meaningful That, It's so not revumenib we as is we kind and have ensure as indeed be our the think. that It So that, about. reps of complicated wanted we we're in the for straightforward. effort commercial one well. is and which to deploy that can will that was that what for us as efficiency case thinking would pretty probably and

it So leave I'll just there.

Operator

now session. will remarks. for over any does question-and-answer Michael to back Metzger call today's I conclude the This additional turn

Michael Metzger

data of the talk about look questions today evening. many thank today. look very Well, the August you much. for we We thanks and the in conferences disclosure, for and in you September to great seeing the operator, you, all a at into which upcoming future. revumenib forward forward Thank to near Great. and Have

Operator

This Thank participation. your for does program. conclude you today's

any may time. at disconnect You

Syndax Pharmaceuticals (SNDX) 3 Aug 232023 Q2 Earnings call transcript