SYRS - Earnings call 3 2023 | Syros Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Syros Pharmaceuticals Third 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. Please go ahead.

Karen Hunady

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

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

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

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

Nancy Simonian

announced built the joining call am as morning, of planned company next as we've thank my of Conley appointment incredibly you my last us. we Chee retirement over Syros. of Thank you, years. last everyone, In CEO, as proud the and October, the Karen. and Today's Good the CEO Syros' marks XX for CEO. I

made make tremendous leadership toward a culture. mission progress patient-focused a on of that science team our profound can translating for a of have patients breakthrough medicines experienced collaborative foundation We difference strong and into new the

forward look my Syros' Directors. Board as on the and team to partnering I supporting continue with service and of I Conley Syros

our this Syros a singular a Following company is strategic earlier prioritization fall, with focus.

are devoting We agonist to RAR-alpha of treatment selected for of potent advancement our hematologic the frontline resources our tamibarotene, the malignancies. and oral

As on profile commercialization. the for rapid differentiated is development overexpression. Tamibarotene I RARA Conley demonstrated have has detail and taken of with that path has high a It become has will patients targeted care opportunity late-stage response AML and multiple discovery the a am profile. complete in a morning, Syros response higher-risk scientific trials. David XXXX biologically rates, we this standard tamibarotene believe MDS favorable to and unfit to incredibly tolerability proud across to a a to time from to clinical the agent

II in first and are company, a study As from next the to Phase in of portion initial this our to we early randomized MDS data reported that transformation be with plan study from pivotal in data December. year our AML we important present higher-risk approaching

therapies. Officer, organization prepare and leadership at Syros. to leadership member over a Conley? Conley over next during would some of stage and month, our am we our transition Chief provide targeted valuable to this call to that, to confident Conley effective team Conley, of during a our turn will natural a expert the been remarks. transition commercial X time and time I informing this Commercial effective commercial As leader company, aspects our building and business. Having has With it maturation brief Conley he over like worked impactful is all to for Business be our for is for into launching years, who oncology an last I with an the in

Conley Chee

in exciting in its on to the Thank all behalf build you, tamibarotene, like our launch lead better colleagues, and tamibarotene thank need into my of to plan work years our all Nancy years I thousands joined Syros options. Since on new here AML on your phase in Based our and X my for and of Syros a the deliver commercialization. team honored leadership. to I colleagues I'm you, ago, partners for NDA we've road map role as MDS and incredibly the CEO would ultimately building established. I'm great to to filing Nancy. development to Nancy, have closely to execute alongside and next and foundation for prepare first of patients that made strides of

With restructuring, focus our streamlined our also tamibarotene on operations program. the recent now we've to

We infrastructure. are prepare execute to on clinical development the and for an commercial continue for filing plan our to developing NDA

pivotal the increasingly insufficient. for recent the are we are robust As with and diseases notoriously difficult are standard are SELECT-MDS-X significant. of approach frontline December building submit data for patients we the late-stage the therapies that in the treat. The frontline portion to believe is have shrunk months, AML year, We initial of in market tamibarotene focused unfit that early options next overexpression. RARA data and development and randomized number in SELECT-AML-X MDS Both existing higher-risk care commercial of a business from in as can readout tamibarotene on

patients unfit XX% important that which targeted for MDS are could who first-of-its-kind that are approximately Given we and are With a manageable. standard patients these and tolerable to become frail, are of overexpression. elderly of RARA for positive new have of AML therapy, higher-risk advancing tamibarotene, and regimens often is care treatment XX% it

XX,XXX a before, annually people tamibarotene. unfit XX,XXX in Altogether, diagnosed diagnosed people U.S. noted this MDS, approximately are nearly with with AML Europe. we substantial are for higher-risk opportunity As and market the creates

I'll the efforts as are to leading to provide for our As to important on these the potentially potential efforts this our engage it activities. If positioned patients over move forward commercial in to this programs beginning closer that, patients. With States benefit to tamibarotene now to turn to critical milestones opportunity. look work through own more we David? team to plan upcoming and pre-commercial approved, in detail. realize we we're to to tamibarotene execute to in the to and market, delivering I United review we deliver through profound David tamibarotene well

David Roth

Thank you, Conley.

We tamibarotene are very by in pleased the progress through MDS. AML development in higher-risk clinical continued and advancing both

in We are on SELECT-AML-X track December. approximately from XX in to share randomized data initial patients early

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

expect this set In at expect potential we our of inform of patients, of therapy. this initial adding least will cycles tamibarotene We standard have the benefit clinical will the completed initial understanding X to care. data most of ven/aza, of

which, unmet existing overall decade. approximately improve ven/aza, of like agents AML the hypomethylating azacitidine, strategy over data Given well to need. evaluate and SELECT-AML-X study, comparison plus shown patients additive for high on safety trial AML meaningfully XX% has the with RARA we with response a of population. we ven/aza of the simple randomized we last first patients, tamibarotene of this months. the patients HMAs, this XX.X benefits a particularly our SELECT-AML-X the with continue patients a initial a that and of very also December, all represents ven/aza XX alone. In complete tamibarotene tolerability. We novel our suited study and benefits frail of of in showed treated informed nearly RARA RARA poor elderly support care of been overall to alone, test efficacy less the patients enrollment of X/X profile of quarter median that a standard XX% data area on initial current provides overexpression as positioned treatment randomized with compared compared assessment the of rate approved myelosuppression can an care care in the of triplet forward AML tamibarotene potential of the this in CR sharing unfit data blood doublet. Today, direct survival months. of a with year, of median standard composite is upon believe median of and and early generally patients from do of and overexpression, with treatment with and, be initially therapies inform to unique on RARA complete which the standard to Based year. historical for as to this response will data XX% with treated care triplet doublet course, focus is parallel, started understanding survival beyond ven/aza to few overexpression data to the randomized shared is limited time with no care and No Unfortunately, portion with well-tolerated rate MDS, ven/aza, venetoclax than standard rate month. In using not with and randomized response we'll response This well a relapse. Post opportunity data or to a higher-risk the months. with a complete the first a the tolerability be the rates prognosis will respond of provide survival our our new The biologically patients readily just from respond all set regimen uniquely targeted to which have in who for of have treated additional approach. We our a Data rapid identified AML, approach composite overexpression next too triplet assay. Tamibarotene experiencing composite direct to with look to a lead-in tami, of an safety a well only of ven/aza who with favorable of unfit improve a late compelling the provides AML, the generally of patients relapse, previously believe portion will

to enroll SELECT-MDS-X azacitidine. trial We patients the plus III ongoing Phase evaluating continue tamibarotene in

project primary to of and initial enrollment approval support data pivotal necessary now end point. the approach secondary can As primary overall endpoint CR on is for endpoint the of key complete XXX enrollment trends a report the very a patients in and by the mid-QX endpoint CR first a enrollment XXX we of to excited continued response of enrollment of with trial as complete XXXX now as using expect approximately the based reminder, included the precisely the in plan more XXXX. to completion the patients initial survival patients. We're We to XXX rate quarter

standard we've seen clinical higher-risk Given these to MDS between defined to well-understood AML can similarities tamibarotene significant the subsets patient biologic data populations relationship across that the believe the provide genomically and that supportive we potentially and financial the identifiable and date, results. benefit of MDS Jason, review readily establish new people patient would quarter overexpression. I AML to our turn Officer, and RARA establishes and to the for Financial with over third of care now call Chief populations Jason? to like our a

Jason Haas

Thank you, David.

Now in in our revenue collaboration the results. million the revenue with to the of our and under recognized XXXX. XXXX $X.X million our of quarter third quarter in disease We as revenue cell of revenue financial $X.X quarter Pfizer quarter collaboration in in quarter to Syros third the $XXX,XXX recognized with million turning of ended consisting Incyte. R&D for in third of $XX.X sickle former in with XXXX, entirely third third million under were expenses Pfizer recognized our that October. recognized recognized consisting collaboration under $XX.X $X.X million compared of XXXX,

tamibarotene. compared quarter third on of principally advancement now in XXXX Our XXXX. million to the are $X.X for R&D of of the were focused as G&A million expenditures $X.X the expenses quarter third

and third charges equipment XXXX, as outplacement compensation laboratory is the of as severance, related held were of sale. were comprised and for restructuring classified the asset costs post-employment these costs million for million benefits, well impairment to stock-based services $X assets Restructuring $X.X of quarter that $XXX,XXX of as

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

XX, September $XXX cash million of compared as XXXX. on XX, were June with Cash, equivalents securities $XXX and marketable as million XXXX,

SELECT-MDS-X expenditure be fund data cash which believe trial is position and to our the beyond sufficient portion continue the from We capital randomized anticipated XXXX, Phase additional to data of expenses current will the operating requirements into III SELECT-AML-X trial. and from our

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

Operator

Piper from from Ted Tenthoff Instructions] [Operator the first Your line question Sandler. of comes

Edward Tenthoff

of of major sort since how by just So work occurred with how her best. I studies thanks landscape to asking you. and and the currently, Nancy all the whether with great job really any just not all and is the I to and think thank hard SELECT much, in you or And there's going changes that enjoyed start I've I you're both for know wish company. a designed AML so you want the also say have I about changing, want and working MDS Nancy, But can't to the much do

Nancy Simonian

Thank landscape you, going SELECT studies. the and over Ted. to pleasure changed been talk bit and your a and we team. AML with a honor to the to MDS working It's David about also I'm designed question little turn since how real the has you

David Roth

Yes.

thanks that Ted. question, So for

significant the have with It's really there to very some treat. saying, is So disease a let need I challenging for MDS. fact not hasn't think changed. that -- by What a start changed unmet remains patients higher-risk just me things

development, majority of maintain this have there Phase and successful And the that's or several patients been ] think, on [ of for the evolution made that. of elderly time we tami that this development what that tamibarotene. reflect advance What life continue has easy trials available quality course, to had that that's put a is years which of preferably, that are us even our and changed, many it need really to in development III into continues drugs watched we've So of and we've and I been not helps administer haven't orally motivates frail various to to however, have over day. or an therapy well-tolerated

We think pack. the sort the issues others from need us at concern do a more of sort these have But wish we we of that mechanism, And have patients that and look we it's success. our of rest separate distinct.

program that we deliver have So our that's and remain why hopeful will so today. reasons we're to ultimately, excited

Nancy Simonian

AML? Talking about

David Roth

it AML AML, of specifically, sort I sorry, didn't the holds answer I in -- just same So think true. but for

that we can it while for targeted. We effective, of be in and do for makes care venetoclax, now It includes an appreciate of properties for with which, more evolution patients unfit, who have, think, I are all bit patient been the which of been standard population use the highly developed venetoclax in AML. primarily a associated a myelosuppression challenging was has that it azacitidine and

still feel upon is ven/aza the Obviously, even so improve we we're with a that And opportunity standard. performance in have that to context, improve to where we tamibarotene program there a there. on adding into the venetoclax backdrop hope of

still I patients to ven/aza patients responding with think there ultimately respond not relapse. significant initially will who or unmet need remains X/X of

for our large the focused still drugs be it's immuno-oncology new helping So a great we think can I much patients. being that there. There's be there's There's place clinic. in still efforts addressed that development really days. to think range And of entered into a it's on but a focus are drugs, on early

Nancy Simonian

Ted, Maybe malignancies the unmet of on of to little that to beginning about overall high medical remarkable potential about we to based survival I a where with has so over year. we're think mean do the be need said, really is part the treatment it's continuing why to And point, And attempts despite just David these years. lot continued standard And inflection just opportunity of changed over see tamibarotene. in change ven/aza, MDS, are is a a I that, think a of to that's in there years. that pretty these excited as spaces. not it's AML sort such in but hematologic add just the one X.X frontline a care, median the thing,

Operator

from next of Instructions] line [Operator TD Phil question Nadeau the Cowen. from Your comes

Philip Nadeau

add congratulations us questions couple us. let on coming Nancy, A and very First, your our from tenure retirement, of deserved. well

First, on SELECT-AML.

bit just additive you control efficacy. what what I give specifically, terms arms think talk you tami seeing population. ven/aza? think data that, between the will the you a more numbers. It and rate you the small XX% on said in recent in some give Can are remarks, a for confidence prepared idea the would data of of in would CR/CRI be this to about that combination. that initial us And the efficacy the for delta a CR/CRI generate RARA-positive population What's general you the patient I might of expected would arm have the relatively adding said most

David Roth

Phil. Thanks, I'll one. Okay. take that

ven/aza have are evaluation So just AML. ven/aza. undergoing the RARA all tamibarotene patients remind patients all we're randomized overexpression. very positive trial, being in first They prospective for again clinical everyone used with combination who's this listening, And represents of compared in the a RARA-positive unfit to for

your So update be our unknown. gives data ven/aza of what And in into initial we this insights about the that. performance RARA-positive is question patients know about us first will that

that very are it's excited XX you reporting on patients, can to We approximately look we forward reminding randomized X:X.

we're equal randomized expect relatively can across you have the a portion. into population, So that specifically on those who split enrolled patients focused and

started this group giving here in quarter enrollment update. So is reminding we who the are first in you, a fourth you this quarter the and

rates. focused largely we're on So response the

We tolerability. on of our CR/CRI primary report are And endpoint, the the the course, rate. CR which focused is rate, we'll on composite

response about As that. we're our to The about in II you prior that this trial, XX% the triplet Phase the aza XX%. from north population ven/aza is response is tami looking mentioned, is response for so of a

randomized we portion. And specifically very had smaller we're supported excited the about. [ of case, to data stated north vast tolerability the that. rate, exactly ] last be haven't patients which of the said, year, number prior safety that how our That lead-in majority in We of far need CR/CRI from XX%

disclosure. you is the hopeful December as So move we're what early the as sort for we just into it date that of sense a to of gives

Philip Nadeau

just enrollment 'XX. That's like SELECT-MDS. sounds now very And one It completions on question then helpful. QX

I Were complete? guidance can to the as that is when think it's definitive 'XX. year-end had enrollment to that? [ there you in a is Or simply it reason there for guidance any Is give accurate going been now and past completion, challenges? unforeseen ] any near more

David Roth

Yes.

rates the activated data that And project line, us trial very all think ways the sites active predictions. a We number latter that are is terms I in of time kinds the sites of our on our to when the how are robust lead closer case. initiates enrollment the with to accuracy of do and over of as best and the they to trial. the more to come to you delivery closer get of the finish based

there's at the confident the So XXX be year. we previously at And just different the I we that first endpoint we in enrollment now little than that of tunnel, we're light time. was what patient the completing can end very, thought feeling primary project for a the think of very quarter it should to the just it's update said, appropriate delivered that this since that

Operator

at further are turn time. Simonian it closing remarks. And for would there no questions I back to Nancy to this Dr. like

Nancy Simonian

tamibarotene look I'm the about chapter as potential the and to Syros' the Board. forward continuing next commercialization thank and excited I up opportunity we of the the service my operator, everyone, a Syros lead grateful to and and proud lives start you, am us of to past on for path achievements joining together, to member the Thank deeply of you, I XX years. for today. patients. I over the transform for am made

the and you. importantly, makes to and thanks Thank analysts Syros for for truly your to difference and years. our patients. entire It team the express a investors I Finally, you, support over want my

Operator

today's participating. call. Thank gentlemen, And you, conference and concludes Thank this for you ladies presenters.

disconnect. may now You

Syros Pharmaceuticals (SYRS) 14 Nov 232023 Q3 Earnings call transcript