Syros Pharmaceuticals (SYRS) 31 Oct 242024 Q3 Earnings call transcript

Good morning, and welcome to the Syros Pharmaceuticals Third Quarter 2024 Financial Results Conference Call. [Operator Instructions] Note that this call is being webcast live on the Investors and Media section of Syros' website at www.syros.com. Please be advised that today's call is being recorded.

At this time, I would like to turn the call over to Karen Hunady, Director of Investor Relations and Corporate Communications at Syros. Please go ahead.

you. Thank issued announcing we XXXX third press results. financial a morning, our release quarter This is the available section release full The on website www.syros.com. of Investors at Syros' Media &

Chee, with We the Medical Officer; our David prepared our Haas, Chief Chief Jason Financial remarks Roth, will our Executive call by Chief begin and Dr. Officer; Conley Officer.

then Chief with also Q&A. is the call Development us available open and here call be questions. for the will Officer, We Kristin our will today Stephens, on for

forth to like make filed implied would section materially everyone report including year other that in call I include on future. a this we begin, we in expressed quarterly report we Factors Actual in SEC by we differ XX-Q annual remind the and morning, make statements other statements our and as that the the that factors our earlier results Risk Form XX-K result on will or we Before forward-looking from of those that could conference may filed of this filings any with uncertainties the events the various forward-looking any statements. or Form risks, those on set

views statements. be of date. our forward-looking only represent and should disclaim today any not specifically We Any statements as of forward-looking or update relied any revise our representing as subsequent upon as views any obligation to

like now I'd to turn Chee. the that, Conley? to With over call Conley

the newly standard joining recent of MDS deliver thank and and our for patients overexpression, for weeks, a to advance higher-risk RARA population. believe everyone, us. to and as the continue represents mission gene morning, Good tamibarotene which care with you frontline Karen. XX% diagnosed you, the we new we third Throughout of Thank quarter higher-risk approximately in treatment of develop

be one mid-November. transformative are milestone will and we data our in are company. III in work from for trial SELECT-MDS-X the as pivotal times Syros at we is readout This a our These ongoing nearing expect Phase exciting our significant

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compromising paradigm with Patients option are and new potential safety tolerability. control. and physicians a better enhance patients treatment disease induce believe has that to durable We and and without provide clinical well-tolerated convenient options a treatment response current seeking the can tamibarotene can the therapeutic outcomes and alter that

higher-risk is X,XXX for diagnosed the total market patients opportunity XXXX, tamibarotene. $XXX market higher-risk over overexpression for the significant tamibarotene opportunity be we in commercial approximately year, billion. the U.S. for U.S. therapeutics a the With will be patients RARA MDS million. with believe will the U.S. each for approximately in By there $X.X opportunity MDS in And

tamibarotene to in awaiting to working our is our U.S. our higher-risk MDS treatment Once thousands approved, first quickly and launch with the for our the filing data, of RARA patients approach we tamibarotene As NDA deliver efforts. are options. diligently move through to commercial to pivotal overexpression own we to prepare goal better

the looking our coming really weeks. in data to announcing are We forward

in to review David? our With upcoming that, program detail. it turn I'll greater milestones MDS over and David to

Thank you, Conley.

SELECT-MDS-X MDS care trial. progress for the new advancing higher-risk standard oral we've from by patients a of encouraged overexpression, tamibarotene, RAR-alpha are upcoming We and look our data RARA to with as agonist forward in selective the potential made the

the in complete tamibarotene the data, evaluating azacitidine. is the supporting efficacy based response to global, a initial The primary secondary will global are full with placebo randomized, which, enrolled to serve survival, accelerated or and together placebo-controlled approval of durability U.S. The on a enrollment of the and very and for trial patients, trial's for XXX trial well. key continues endpoint azacitidine the As that XXX basis continue of happy as overall double-blind, to had is reminder, report to the sites we can analysis or endpoint to potentially approval over XXX SELECT-MDS-X enroll patients CR, combination go compared up

in of correlation peripheral The and important as with due as its is blood CR endpoint an to primary well overall efficacy counts. clinically survival meaningful endpoint improvements

successful, need. benefits reinforce confidence unmet achieving with a clinical potential compelling, SELECT-MDS-X are in associated our to if CR the together, and significant Taken address our trial, the of

The XXXX who prespecified primary trials endpoint. have with quarter in previous profile years advancements therapeutic MDS. these a in support observed doublet our These waited along data for excited the new using for futility their in tamibarotene SELECT-MDS-X azacitidine tolerability analysis passed the of first the patients conviction of trial plus strategy higher-risk We're in a based condition. on for favorable

by not how successful that that to by asked the planning and profile. you well-tolerated be generally medical mid-November? primary investors believe results positive result the safety are prescribers. one its a only a with A will in hits pivotal is often outcome you're would that share community trial offers trial one met of with us endpoint, excite what but for? We kind that enthusiasm Or we interpret are should hoping We

over They the higher-risk in expert for can for strong likely conversations it additional to treatments physicians, of MDS the particular, and rapidly that that endpoint meaningful be that been become tamibarotene we over standard we've given efficacy, time could need had existing be usage. of a care. limited exciting on decade. due long beyond a these believe achieves therapies in drive a with well-tolerated targeted result our ever a and Based prospect clinically have periods this therapies agent the recent held new event approved and population. considerations, in in was for first highlighted challenges emphasized in our use with HMAs trial frontline primary In successful June In medical would no

pivotal patients. very as are are these we potentially step to November they to report drug closer this imagine, data us bringing can to move to transformative expected in one excited you As

to to financial the turn Jason, Chief Jason? call review over Officer, to like now third Financial results. would I quarter our our

Thank you, David.

$XX.X turning third related count million expenses. third financial quarter of contract Pfizer. R&D reduction a Now recognize R&D million primarily compared revenue manufacturing results. in XXXX, the decrease of compared due expenses consulting, of the the $X.X in termination We to with were The in million XXXX. XXXX, decrease recognizing reflects external $XX.X XXXX. reduction as any quarter and third of the as revenue quarter agreement third the quarter to to to of quarter The last didn't and in year's of our in head Syros' collaboration was in third

of tamibarotene. R&D are principally on the focused Our now advancement expenditures

facilities net $X.X the a of expenses. loss loss XXXX. count principally in $X.XX XXXX decrease expenses, $X.X a of quarter or as and share reduction of same G&A million We reported to per $XX.X head a due million XXXX, compared expenses net consulting quarter third to the period quarter million million for per share in for the $X.X in was $X.XX compared of or in to the third and were XXXX. The of third related

were We requirements our into XXXX. anticipated XXXX, to capital of million June Cash September will as and our third expenditure expenses XX, XXXX. compared be current cash operating and of believe equivalents fund million, the position with $XX.X XX, of as quarter as cash $XX sufficient

I operator call will With questions. for over that, the turn to the

First, will Instructions] [Operator Sandler. Ted from at Tenthoff we hear Piper

on controls And the this. want taking right you maybe you to what the then you reemphasize us through terms sense coming both in they most around appreciate walk data could MDS? here. also and I the how I recent for kind give question, how us could what back of interpret results show in historical in for just excited should aza clinical experience? label up And we the a the corner AML higher-risk of can

David. I'm happy question. answer your is Ted. to This

to and data, as hundreds complete have in the XX% aza-label the trial. rate recently, benchmark to the in reported same. an a control had rate trial for there's in in variation trials, control More more been a trial. of use randomized rate So recent Obviously, trials I CR low been trials meta believe of one the up CR has from with respect we've arm regulatory of And at has And There of aza with have a analyses XX%. standard the that some looked the accepted control is the a range. the remission to seen XX%.

CR we're So to the is comfortable anticipate. the could high mid- one likely very rate to that teens going of type something be in

the months, as for response if you control of paper, pivotal had of short. that a seminal the aza that is about to duration literature, of response the package duration look the CR part Oncology reported Also, the the for PR, the for the not that outcomes population compared the months instance, included publications, X.X label, in aza rather on also Lancet of data just the was but the believe time CR. I of X plus of paper arm MDS is a at higher-risk some arm

response aza X-month X is in Now X to typically the onset long. anywhere could to for or It X keep mind to time range. the of relatively be in

some the longer still response therapy will of part because for may half benefit. to several because your months take year last of be thereafter the and the duration somewhat it it can So will may and better achieve have continue patients

in performance control. the So of the for aza the those types are expectations

Now one I'm could question please and didn't just note second what was, down to you part answer if happy as well. I sorry, of I'm -- your your that

really terms can can? of how helpful. to MDS, data was part the we infer that's -- looking And even in we just if No, that at from then AML second of sort

Yes.

we've mid-XX% was with can to and apoptotic and in leverage we high rate So of we look, AML CR high venetoclax. seen a itself that have venetoclax aza, The that the similarly and tamibarotene if rates experiment when diagnosed with unfit experiment in and AML. the an tami was idea very newly range aza mechanism rates has we've see really that the combined CR/CRi

could seeing even Phase envelope X, on up a we the all randomized that. whether can we to better? do And we push set combining by So II

of we are study that could out achieve. one outcome essentially on that maxed demonstrated The what

having of don't not aza. the different view as that experiment. part testing any trial that doublet The is tami of we MDS a totally MDS So a and trial. value towards of is Venetoclax experiment. outcome predictive the It's the

a And really outcome. relationship the the venetoclax outcome, AML between see we don't and so

tami-based quickly. And into we had that saw tami out arm that we regimen been that durations patients control the their a set, ven/aza arm, responses. And responses some encouraging nature. adding of see who restore which to lost And high report, been I aza, to and time who response response, rescue said, occurred for ven their initially remission. also to in AML who context patient point, the about still relative even nice to of had year months that have believe activity did our things of them at responses having That on complete continue X at had included in regained the while about we regimen the control data then back another the continuing of responses just X enabled

we really that important those data. very So are feel

which And comment say about with safety. result, has is important, to the last I'll do that trial

conditions these are cytopenias that's its from comorbidities make elderly, So as of The tami-based to even of the we saw don't illness, it's it complicated patients absence points where a have well at high-risk that's added really the we use and and perspective, very and support a have and And of complications. tolerability should like outcome them challenging. their because it to that a that and the you generally important aza for a important is backdrop in containing administered, give tami main medical regimen myelosuppression in challenging regimen our from know, venetoclax. no is convenient. regimens, the appropriateness evidence of just beginning generally tolerated, other often our it, patients regimen problem in their And are really easily often population MDS, the additive of myelosuppression they believe because data the suffering

about a our to MDS looking with and weeks, few So you. we're to sharing very all experiment really outcomes told, just forward those fruition in excited coming we're

Next will be Nadeau Cowen. question from Phil TD at

said, Ted forward looking what data. the reiterate times, us to exciting Let really

and give able what be first be will CR sense and on rate can some that to So much you to have presumably you anything able I also release, how durability that but put guess safety, question of is that you'll else disclose, data you release? press in data us might

thanks for So again that question.

want just for doesn't again, remind I who's So background just much everybody. just to context, anyone that and to have listening repeat, as

a it's -- is global, placebo trial randomized, plus this placebo-controlled plus So tami versus trial aza. aza of

rate, CR rate. endpoint remission Our the complete primary is the

of those evaluation arms. targeting our report enrolled CR of And first We're we're in endpoint the enroll. primary going the this survival. across -- patients. evaluated pivotal of to planning XXX rate XXX continues to the of in future is mid-November, the endpoint be So a a outcome secondary to overall key total survival But to study support X

So not overall our survival time line will have one the is in I of we thing top will say mid-November. at

you So secondary about that our endpoints you an in results. understand for we anticipate to expect CR have hearing important should because progress. still to not But that's that other experiment are do

include about the of may overall improvement. around responses time like to have occurs, to like obviously just you're other and complete have response, as the how may well So the PR the complete CR data rate, we addition duration response response, it suggesting, which quickly we in will information heme

with solid hearing it's in I a and equally higher that going elderly understanding as together, patients you're is tamibarotene for are we're think that very appreciate. focused well. be we to have safety safety And how often mentioned as efficacy. this I my importantly, everyone important. in again, important and think to to going with these data taken critically I prior But share. going to of on is These, MDS. response, about population, this overexpression forward look gene I very And you know And comorbidities. have to is to think is to in And RARA working risk patients critical other

with again, So sharing looking you. looking -- all forward it to

the this very And you to in FDA do endpoint of the terms helpful. primary second order other to filing? do That's need then of are data Are in be file? the question, filing, completed you there what that prior And the secondarily, new getting need a things release with post to would pre-NDA have also filing? FDA to have that to to meeting

Yes.

have the completed So corroborated obviously, has will that all thoroughly been we data of pulling and validated. in

through possible be perfect. There's we're information, review get that So to do, there And when sure that I that know are assume regulatory other need to all the routine nothing about hear everything it's we toward make unusual end. you you can working hard then is just go and We've made is straightforward down. and that is objective. what quickly as order, hard great and possible And towards as good buttoned progress say working that efficient as in we'll in -- I the as and to as can so submission possible. interactions.

We to forward look the day.

at be Next question Citizens. Jason Butler will from JMP

over commercial about me Let the getting my just for months tamibarotene maybe release about we'll talk to excited you're do results, work very doing add see of that the but they're the data if in ready you comments commercial the positive, launch following and of MDS? Can -- soon.

question. the for Jason, Thanks, here. Yes. It's Conley Yes.

going the patients. can for working detailed it broad preparing we have plan we get access team to to and we forward last so and been very year launch, a has that the drug to have our for [indiscernible] Our or ensure

conducting I that already of to accelerating would We've been a comes several say work I would activity, well. data, lot lot And prior say, we Post will it data. as a in of buckets. be

sort RARA First, biology effect that of ensuring and market around of education awareness overexpression. and the there's

build we'll commercial looking and size to and We field the are how that our infrastructure at opportunity. our support force continuing up to

readily obviously, milestones that, And are hit the ensuring at ensure also brand as that we that diagnostic have manufacturing, physicians. patients to then well so being and our and launch lastly, available plan there for and drugs that's is

Markets. Next Brookline question at Capital Leah be from will Cann

questions. X So

some from results? burner, The question the second at in a XXXX. thoughts it's that back become my of but past, or any the is been know any for plans if something sort -- on presentation more meeting of AML medical the on show recent plan to future? the I of from how on there's the could detail is the to data relevant there tamibarotene, first And

one. which -- meeting, after of SOHO we present I'm I'll AML outcome Leah. -- first shortly the the the happened And from not the data aware disclosure. complete maybe our Thanks, the at take data did

to available, may have that I we're had that happy a at think haven't questions if yet. should any you address So be and that chance to you about look

those I data, have apologies. do

for second to problem. no over one Yes, that about turn Okay. Conley. I'll And the one then XXXX,

Yes, I the can XXXX jump is asset believe in potential, on high one. with and that Yes, CDKX. we a be tremendous best-in-class could

all that has to tremendous that. and of prosecute potential, with larger across think potential asset, company to this pharma better this this it's fully do of the the tumors there's suited I hands resources in a multiple

business we development continue asset. for for so to opportunities look And that

At this will Chee. over I registered. Thank you. back the have call other to questions turn no we time, Conley Mr.

you, of exciting for a waiting of very and joining, Okay. us potentially you, Syros. for for and support continuing Thank patients everyone, better thousands operator, here thank for treatment time It's option. for MDS and the a higher-risk

you. As out questions any always, you team a further and great if to have please Halloween. reach Thank the have

Thank and call at your for for your we does again, And lines. ask today. time, attending. indeed you. this gentlemen, do that you you Ladies please this conference conclude thank Once disconnect