Syros Pharmaceuticals (SYRS) 10 May 232023 Q1 Earnings call transcript

Good morning, and welcome to Syros Pharmaceuticals' First Quarter 2023 Financial Results Conference Call. [Operator Instructions]. 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.

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

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

Chee, Officer, our Christian Development Officer; Chief also will open Chief Officer; call be We Scientific our and then Commercial the available Stevens, call our and the on for Conley Eric are for Olson, Chief questions. will Dr. Q&A.

and representing XX-Q filings statements. our any begin, on like that factors, of events implied XX-K should section including or result our forward-looking the statements of will obligation I and include relied in that Before forward-looking the other only from results everyone we of with we call Risk in our statements quarterly subsequent other Factors views make specifically as as the by any not morning this SEC various We Actual represent and make report statements. materially would or or any that Form we the upon disclaim expressed a statements and forward-looking conference report as those as any Any could we remind our forward-looking may filed uncertainties this views of revise today on future. any be forth Form risks, on date. set differ update to those annual to

the call I over would to turn now like to Nancy.

hematologic strong execution goal of AML Today, with move delivering and we our XXXX be us progress you thank and focus closer to of across the on Good will standards in malignancies. is clinical Thank you and morning, everyone, APL. programs we you, off new for treatment a MDS, to as joining frontline sharing today. start care of our for Karen.

SELECT-MDS-X this quarter our response SELECT-MDS-X enrollment of trial, in about announce XXX fourth track complete to progress trial and we and on the continued on our the of to complete year enrollment from remain XXXX. in the third quarter of are We data pivotal excited in patients

We protocol an survival the SELECT-MDS-X as as based convert trial in remains on a design. secondary XXX complete endpoint. survival endpoint key key a include approval the the primary to to overall an trial one on to accelerated recently The using a CR for trial endpoint, have overall including OS, patients. if the potential secondary we based warranted, amended full of efficient approval response By

impact Importantly, SELECT-MDS-X. pivotal the additional timing this does amended on provide our shortly. amendment not the of CR David from protocol details data will

the efforts Turning from last II AML, the portion to of we Phase lead-in, randomized in promising safety quarter. our data following trial initiated the

in year expect the trial from to by data continue XXXX. in this followed quarter data this of initial additional We fourth

an also remain of the as on in a study registration on in half We on track confirmation was to this the dose update steps XXXX provide second year. pathway next the APL of

months setting, XX need lay our and to through goal upcoming each and to market significant of the AML We ultimate positioned of in on effective, well address represent we convenient targeted commercial populations opportunities over own the which will in States. efforts patient to in turn these which lead in cards and MDS, each the our groundwork our catalysts therapies frontline APL multiple delivering better and believe upcoming milestones are over together, United for Taken options. to closer programs the we well-tolerated move XX progress of

more detailed ongoing update With to clinical that, over I'd David like David? our programs. to turn to call a the on provide

MDS patients and with I the evaluating tamibarotene the represents azacitidine III Phase diagnosed higher-risk overexpression, SELECT-MDS-X RARA patients we which trial, protocol Today, Nancy. amended combination with focus higher-risk on MDS. which the of of you, Thank approximately is will in believe for XX% newly

tamibarotene placebo trial a a placebo-controlled double-blind azacitidine plus is versus study plus reminder, azacitidine. the As evaluating

while As as a primary approval. Nancy use mentioned, endpoint, as we complete to recently amended the potential continuing the study overall endpoint include for protocol response secondary key to survival

our secondary key same Recent FDA's remain primary endpoint an use study. also of confirm receives could the response a need said, That rate separate and allow either study. data the feedback study efficacy addition or SELECT-MDS-X in complete continues benefit approval if as for of primary complete with survival the response as of supporting accelerated future, our clinical in to endpoint to tamibarotene CR overall appropriate approval, endpoint the avoiding the potentially full for support confirmatory approval a rate full to durability in accelerated will on support

therapeutics. by us XXX to support and same identical patients the The consistency advantages over FDA eligibility at trial, guidance on offers primary secondary since they in analyses use confirmatory This the to same if patient CR with approach all trial full endpoint endpoint. is approval a This conversion support controlled support and the and a to accelerated support protocol to of also of enrolled randomized draft support criteria. are many the with to approval potential to needed, one-trial include consistent of ensures a subsequent single same trial the the separate recently the the enrolled the oncology primary allowing also population approval, instigators issued confirmatory accelerated consideration clinical sites that

increased confirmatory underway It also to are delivery well regulatory them provides our our for the we with FDA primary data provide endpoint of data when the evaluating with that confidence assurances decision-making.

one-trial clinical potentially the and limiting efficient confirmatory for data of more this delivery In speeding trial-related expenses. way addition and costs advantages confirm to a being additional to design has benefit, a

newly XXX the primary secondary higher-risk amended will endpoint. a of study patients, the diagnosed power enroll key the protocol, SELECT-MDS-X the total XXX for Under supporting initial endpoint to MDS including patients

or and full report then in the of the accelerated that year either using will XXXX. CR we pivotal initial continue third in expect XXX quarter enrollment this support CR data mentioned, Nancy we to the necessary endpoint a quarter of as and Importantly, approval complete patients to fourth of

higher-risk to for tamibarotene the options Fast we population, critical XXXX, underscores including review this for treatment further January the treatment group designation patient available As by that been need FDA designation quarter, us therapies. discussed of and MDS. last provides advantages, new for the in several a lines with underserved time priority This Track has granted

existing standard months been HMAs the since only Again, XX% beyond response offer a XX.X approved survival therapies of and hypomethylating a no have XXXX. of care median more agents rate and complete

with Like portion represents medical a study diagnosed RARA our need. the initial announced with previously diagnosed not patients respond unfit ultimately majority to a the X.X MDS, significant those very study patients of with to upfront AML, that the had a have only We've treatment tamibarotene poor unfit higher-risk and These rates with months. newly relapse. Of of responses prognosis of AML Turning unmet initiated median AML. approximately patients with survival randomized overexpression. do of X/X overall in in ven/aza, we AML

with XX% to underscore year patients existing ven/aza, leading outcomes we approximately with of no in relative historical in combination an to the the improved standard data triplet care of of potential ven/aza safety RARA myelosuppression. These are AML who the As including combination data of the of toxicity tamibarotene to of increased overexpression. and with deliver positive rates onset demonstrated evidence of for and last SELECT-AML-X, announced of XX% tamibarotene portion a rate action late rapid CR/CRI

X:X the portion safety the randomized unfit trial combination with tamibarotene compared designed overexpression reminder, and in patients RARA ven/aza of composite rate of the the a with primary rate diagnosed approximately randomized -- as efficacy to XX CR As AML with or in is CR/CRI evaluate ven/aza the to endpoint. newly a

We data fourth on additional XXXX. remain in continue track this report to with to initial year quarter in expected data the of

for believe with arsenic or to regimen intravenous evaluated We novel involving in frontline acute and up by ATO, year. has patients to all significant while study the timing leukemia. on which to oral increasing creates XXXX the X ongoing form burden of Lastly, registration-enabling for over further providing XXXX, providing is a confirmation hours the an XXXX update an being treatment is evaluation standard ATO nearly dose in trioxide, regimen study in burden promyelocytic I'll that of treatment each this treatment The the planned a infusions, and to for cost reduced a describe an treatment path and We for forward of turn second to a X access our offer dose care development utilization. oral the to XXX current also patients, year heath of reducing half potential effective, study look confirmation APL. in currently

With that, I Jason? like our review the first Jason quarter to to call to results. turn financial over would

Thank you, David.

Pfizer. XXXX, our XXXX, revenue Syros Pfizer the under consisting collaboration We in under collaboration turning to recognized $X the with recognized consisting million our collaboration $X.X of under quarter in our with quarter financial $X.X of $XXX,XXX quarter of in first recognized million revenue our and results. of Incyte. million first entirely of revenue first recognized with revenue in Now

advancement Based operating first continue This drug programs XXXX. primarily relating XXXX $XX.X our to increase million partners. to collaboration expenses was in were expenses R&D stage of reimbursed future company's late-stage discovery of as the our we the our compared quarter R&D clinical current to to for quarter of will first million on $XX.X programs. be plans, our by due the that the expect

increase for quarter to of supporting to relates were million the quarter of late-stage expenses compared The the G&A in the our first $X.X clinical million XXXX. first XXXX programs. of as advancement $X.X

per in first a $XX.X or of or $X.XX a period share million net $X.XX XXXX. share $XX.X reported quarter per for We loss the for same loss net to of the million compared

to will and on of cash compared expenditure fund securities trial. XXXX. SELECT-MDS-X our equivalents which Phase cash and marketable data million with beyond $XXX XX, anticipated the data trial and sufficient March from position operating the SELECT-AML-X million expenses believe as randomized XX, into current the is We from be portion capital our $XXX Cash, III were of as December XXXX, XXXX, initial requirements

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

[Operator Instructions].

Cowen. question first is from from Your Nadeau TD Phil

Congrats on the continued progress.

the powering to to seems quite a enroll of like people you'd be in you're curious additionally It addition willing there's on OS the that the going the SELECT-MDS. endpoint trial. I'm OS few endpoint. if to the on First, disclose

you likely So will powering curious just disclosed it exactly be. seems powered. what the like be it's well I'm if to

will the thanks for Phil, answer that. question. David

Yes. Thanks, Phil.

to the between assumptions the a X CR arms. X to based endpoint power on overall respect primary study remains secondary And difference that to the on a just So arms, as previously rate. powering remind the the the everyone, response demonstrate over and enough XXX to endpoint, between difference detect survival rates we've XX% XX% with focused is power provides complete assumption study in a patients key median powered in are a shared the

the in prepared the And and what in control arm, for testing terms the of if increment the so, XX.X remarks, for assumption assumption referenced arm? the that months the is the is you

Yes.

specifically and so are the So a that, statistical -- we high single you're for azacitidine the the teens. assumptions haven't true in data the MDS actual tried higher-risk agent as those are. in stated correct But what

assumption. I So that's think reasonable a

interim Perfect. analyses And the then along way? are there

there the obviously, interim stated could are be is secondary as analysis out the analysis, the endpoint, the So that to completed key reported -- haven't interim when but is subsequently. CR along analysis primary secondary initial analysis final we the an study and for the way the interpreted

And really early. the available? when appreciate could this. on it's survival on overall Great. question estimates data then that last be I Any

available. when haven't we guided yes, be data that would So yet to

As endpoint. survival an you know, is event-driven

future. to going that's key But the have the which be approved, delivering So and to is project data will we're hopefully that's right CR the upon the pivotal now, which on rate. in the drug we're anticipate we certainly we data, that focused something

track year. by fully quarter And XXXX. just data available to remind patients primary of needed CR And analysis the on we to XXX end have third for the in remain this for expect enrolling the everybody, we that of the

are that. we're the excited. survival key really about will which on based come things And secondary greatly obviously, these So the after endpoint

would you Great. last about if discussions redesign? will have the And those when discussions you -- And question then about expect FDA trial you to recent from discussions? hold FDA had not, preliminary XXXX, us. -- On

the the that So question the registrational second about Phase study. we've answer the dose sought. approval also point, best III it been and that think guiding information confirmation of share half by that for to I'll and year, saying that we'll be the interactions, our reserve cetera, details on in we'll at will be regulatory around this for moving to continue say update I into et will And provide of And all around the which the we trial for update. that an plans trial, things

from Ed is one Tenthoff from The Piper next Sandler.

Great.

I think morning. Phil had his this

really So are the just about to to us and only ask data, what really expectations to remind plan Phase And what II would thing your SELECT-AML. respect love things? is with go/no-go the

going I'm David to Ed. Thanks, address that. ask to

Right.

again, to when data to study, not lead-in end toxicity of of coming last SELECT-AML-X the onto the shared the sure We make year, for increased adding ven/aza. just tolerability of the on reported we the progress So great drug. from We tamibarotene see backbone demonstrated up everyone at safety the is the do speed, study.

And really we're So move that in of randomized the into about excited that the we us portion that. enabled trial the to first quarter. initiated

pleased an everyone that study. Reminding the rate. that were see primary CR/CRI We endpoint XX% to also is for

year. the that enrolling ven/aza And randomized X doublet, versus It's expect quarter have ven/aza. of update trial. in this to on a the tami it's currently we So the arms, versus fourth triplet an

Jason next question from is Securities. from JMP Your Butler

the just follow-up data And AML the you patients set? come do be ultimately the on have the ultimately, I question kind of us data based final a of Can guess, cut will a I think based year? is, on get first of Or later go-no guess on maturity this of study. a you sense give number I data? this it to you we'll of decision some the can

Yes.

in data So -- specifically well update of of the we as guided on just this as haven't and maturity. of on prior our be and numbers patients part the one, year up the would the of to at that to follow end the also question terms well

randomized the quarter. first initiating the we in reported portion So

So give data end to this potential the you much as sense can for might sure of be the toward that a the how year.

And in This compared the RARA And specifically, be a our be data triplet. II. collected haven't Phase prospectively on of criteria, bar of go/no-go very specifically ven will what again, performance for the would next positive trial. the is, moving registrational then patients we again, aza guided phase to into triggering investment, the the it randomized first a plus to

again, but totality we'll very to in excited about specifically. the of order more So we're to really that, that answer see data have the question

next The Oppenheimer. Mark from is Instructions]. [Operator from question Breidenbach

from couple a me. Just

approved on I the accelerated full on influence be still endpoint could you that hoping approval tamibarotene on would in prepared a just versus could I in point. there's possibility based gating maybe factors it that be fully CR approval. an First, think expand be alone what remarks, the could a was that MDS, end accelerated heard would or approved I the that

ASCO noticed at then a give testing And a drug. second just had quick XXXX. at expect or question. I what -- new up still just ASCO ASCO going update you and couple presentations at trial of enrolled or from status Maybe data these this wondering, to being SY-XXXX. include clinical a I'm around coming for us are poster to

Mark, the Right, that take and question, take I'll David have I'll one. first XXXX

Sure.

support or remission. context evaluation, either also the accelerated recently of to could will that the primary obviously, always, even with appropriate the And So endpoint the is full of that FDA totality the really duration in complete approval, more reiterated the their us inform the an as regulatory data decision-making. the the rate of efficacy response has approval

that So the CR package with to studies clinical what's favor meaningful really surrogate it's CR a what evaluation. overall the sway depending clinical But a give specifics multiple is our to pretty There's pendulum that clear have on approval full them of excellent data correlated surrogated -- going around the survival. approval an in the provides for remains benefit. versus

data. on the going really that so of And I our to totality it's think depend

for confirmatory exists that accelerated And got everyone, for the might to approval acknowledgment if there a remind meant really, a be has always we trial, approval. just accelerated that need an potential the the that

and known FDA great the our one This to to that countries the how really includes enrollment, footprint approval. the along about sponsor that increasing they're committed been decisions. need progress we've they global by with the when that making we've reassurance delivering do So the with might coupled all that XXX now actively provides expansion as over the award enrolling them to a XX to make trial confirmatory data encouraged likes really thinking that sites, to understand and awareness of is in really a their

that both it in ongoing one potentially if study progress take it was thought and to of was sensible we the objectives use that So very to advantage fulfill needed.

anyway. Of course, approval, a certainly, then required. if it's just But it's and thing to do full an it that important wasn't do continue we'll to

do you yes, then X that on question we abstracts and posters Mark, or have, the at XXXX on ASCO have XXXX.

a we for program. actively that reminder, looking for as Just a partner are

a we supportive And because of be populations. fulvestrant in PDAC our and best-in-class instead further presentations, kind very the are program for as patient where putting development think CDKX difficult-to-treat great cancer other focusing of the this the being these in looking are we experience know, these data to this and think in they're show on ourselves schedule, But see dose We you in -- for potential will presenting activity agent. be X one more this into and clinical think on data compelling really with a partnership. breast we very we combination, a have I inhibitor our I capital and of not we'll

remarks. hand at back no further time. are to now will questions this I There for the you. Thank call closing Nancy

and you, you, support continued reach and Please and have any great joining a operator, with Syros. Thank to us for questions, out thank us at day. everyone, your today for further

you gentlemen, has and ended. conference now the you. all Thank Thank Ladies for joining.

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