SYRS - Earnings call transcript Q1 2024 | Syros Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Syros Pharmaceuticals First Quarter 2024 Financial Results Conference Call. [Operator Instructions] This call is being webcast live on the Investors & 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.

Karen Hunady

Thank you. This morning, we issued a press release announcing our first quarter 2024 financial results. available at Investors www.syros.com. is of Media release website Syros' full on & the section The

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

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

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

Conley Chee

Syros. for an thank XXXX year Thanks, for marks everyone, you, morning. this and Karen, joining important

we tamibarotene, for potential development our programs new focused standard acutely treatment and continue hematologic the pre-commercial of frontline across are care malignancies. We as a activities, of execution advance to clinical on

AML. encouraged very unfit higher-risk We our and progress in by of MDS programs are recent

without the to our utility This the by program. futility forward as overexpression. was modification. our a anticipated, data that important data with reporting azacitidine in was result by pivotal an recommended III we designed independent look year. Also tamibarotene pass to we as granted step milestone reviewed will for treatment SELECT-MDS-X newly response. of of complete They unfit committee. data prespecified a David shortly, endpoint continue discuss And is combination RARA analysis our the while of was The study and primary passed And recently monitoring analysis. to interim in to evaluate this a April, AML Track reminder, this Fast our that that with As trial blinded FDA for the meaningful Phase venetoclax interim Designation diagnosed the remain for is mid-QX

Track by And of mid-QX. important therapy to to demonstrated Designation therapeutic provide data this As serious a medical is with option compounds the II azacitidine the AML believe with granted from that described to you the MDS from initial which the treat Fast conditions and patients data year. know, for tamibarotene confidence to including FDA to data trials readouts SELECT-AML-X, for granted treatment as of third RARA for reflects quarter not I combination higher-risk Track new for and which trial before, the second Phase This additional in SELECT-AML-X year. designation the III reinforce the the potential need progress this that are only designation received address at that nonclinical Fast for AML in a RARA overexpression. Together, and speaks overexpression. needs. We forward pivotal potential MDS the data that for tamibarotene look of SELECT-MDS-X and continues safe with efficacious our mentioned intended FDA to reported of or to Designation our our last is I expected unmet We from to end in that Previously, data strength this Phase tamibarotene. we we ahead, clinical our expected the

I'm also details of move following to deliver We our advancing in turn filing. With launch a sharing David? we these by and over now to our David closer readiness approach the preparations we really review progress it tamibarotene to As forward in pleased more I'll approval. our detail. activities, programs readouts, that, patients as FDA potential to look milestones we to upcoming so U.S. in our can effectively launch

David Roth

through Thank you, Conley. progress with late-stage development. excited tamibarotene continued in We're the advancing

pivotal and March, prespecified the interim recently an of support report recommended it the As SELECT-MDS-X modification. conducted of are to X analysis, who monitoring complete XXX data Conley trial by this enrollment of patients the the blinded Syros on highly as continue necessary at independent the data futility we track completed by response data the remained that we in of without looked primary that by analysis, year. And was middle which mentioned, remains trial, completed the and we to rate passed. quarter CR arms to we encouraged announced CR endpoint across Analysis data the committee, fourth

This we're analysis concerning meaningful pivotal registration a in in a were the milestone, cannot trial passing particularly is granted. In taken higher-risk futility noted. no signals addition, be safety a for MDS study,

provide futility become interim safety. and efficacy have half underscores reasons the evaluation for Over compounds several or the the to in patients, look analysis on failed and/or analyses years, has outcome narrower we potential to enrolled higher-risk competitive this landscape forward data to pivotal tamibarotene of and encouraging past the analyses based primary patients year. to for needed of narrower profound primary This benefit related later of an MDS as our

targeted well higher-risk a the profile, placebo-controlled to simple and tamibarotene important higher-risk a be a comorbidities care underlying studies the which preclude can efficacy our treatment which of improve is generally of and have identified we date, versus provide well double-blind intensive survival We're medical event excited June The diagnosed hypomethylating present biologically ongoing opportunity agents RARA with new trial to with webcast overexpression. the azacitidine azacitidine of and experts discuss patients over disease and reminder, using higher-risk higher-risk rate current disease MDS specialists in approach patients patients with provides evaluating XX.X of and program, the newly for standard provides MDS decade, to for To design well-tolerated and and treatment with ongoing approved MDS complete RARA joining elderly perspective with placebo have in MDS tamibarotene test. To overall tamibarotene discuss a the on pivotal will patients care opportunity of the just demonstrated and in hosting who additional overexpression a to limited randomized who tamibarotene. in particularly the MDS is combination these topics. a a have the be newly a higher-risk commonly median months. No beyond response treatment existing therapies for safety XX higher-risk with in MDS our readily trial blood SELECT-MDS-X been diagnosed XX% III As SELECT-MDS-X as on MDS, are that options. and as of biology on landscape Syros Phase trial

to AML. Now turning

and for the overexpression for tamibarotene with decision continue RARA detected azacitidine combination AML were trial advance to as II patients, RARA the therapy we tremendous for test. This to clinical SELECT-AML-X tolerate FDA the Fast grant In with of a overexpression. diagnosed venetoclax Designation Phase intensive We the randomized many reflects safe for by newly AML designation and are in an pleased Track whom need effective tamibarotene of April, treatment unfit patients patients in gene unable AML FDA-approved treatment. to announce unfit to in with

data especially potential are with the continued tamibarotene review additive CR/CRi in care the of which for RARA that Overall, in initial bolstered of also compared were demonstrated the interim treatment standard overexpression. encouraged with with of We was the AML FDA to safety support this based given analysis that data to tamibarotene CR on rates triplet in combination designation a of we in encouraging of patients by data results randomized SELECT-AML-X standard portion from toxicity. an prespecified frontline the care. These included saw the no the that and study, the

results. by of first analysis turn Officer, of of quarter from the patients QX the randomized the Chief year now this data trial data to confidence in the our Jason, readout our standard of results also in portion to over from and pivotal to the in in look AML, is Phase MDS XX quarter like of a care of We to year. I in financial we would middle data uniquely and review in prespecified combination tolerability evaluation the the tamibarotene positioned on our in of improve date, believe with forward increase ongoing Based AML and SELECT-MDS-X SELECT-AML-X higher-risk III third to to these Financial the azacitidine Jason? higher-risk from over upon call MDS. the reporting and believe activity tamibarotene we this clinical trial

Jason Haas

David. you, Thank

the consulting, reduction were to was the The not the of contract quarter a R&D turn of million Pfizer $X year. as R&D decrease quarter and in of last We results. for reflects $XX.X $XX.X recognize reduction revenue first quarter this first collaboration our external we'll the manufacturing decrease expenses in quarter million late and XXXX. expenses. Now to for first termination compared related financial in headcount quarter the million did to primarily XXXX. first The Syros' of agreement any due with compared XXXX to

quarter On as and share reduction equivalents of $X.X same we focused as principally the to a as loan XX, the with per were tamibarotene. G&A March net our for million or million first the million $X.XX expenditures same agreement share were interest-only Oxford. to facilities quarter on late or per in to compared first due million XXXX the November provide related more XXXX. Cash, million with primarily of financial loss on in December upon the last X, are to to a period We us The XX, now reported marketable flexibility May headcount of extensions compared will with further was $XXX.X with milestones. to for $X.X XXXX. million amend net by period and of loss The cash XXXX, X, decrease agreed a $X.XX November $X.X R&D year. securities expenses. $XX.X compared $XXX.X expenses, extending consulting Our September from X, certain of advancement the in XXXX, the XXXX, quarter of as XXXX in as achievement X, amendment and expenses

increase available of us to certain the us of will an upon amendment $XX with million Oxford's amount the additional discretion. $XX to available million, term the addition, becoming $XXX tranches from totaling available loans million milestones X million and allow to achievement at $XX In becoming

SELECT-AML-X With period into third the XXXX, our quarter operating to we will amendment, our current expenses our trial. With Phase additional extends be of expenditure I the data and SELECT-MDS-X fund the cash for III sufficient interest-only operator portion November requirements position will beyond anticipated the the turn to trial that, which the the to XXXX, questions. pivotal data capital Oxford believe of over from randomized and call from

Operator

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

Philip Nadeau

progress. from the us. Congrats on Two

First, on in the analysis interim SELECT-MDS-X.

think analysis? to give And And could update involved QX you'll go, do in correct? come? think analysis on primary information the I ultimately that of decision patients enough the question, you futility AML, decision could the second you have If that development not, at looked XX% any no-go bar endpoint. make in in then when for who AML? the a pivotal statistical information will post that be Is on said you us additional the

David Roth

appreciate It's Phil. here. the questions. Thanks, David We

analysis futility The going did a an time analysis. contributing final primary correctly. analysis independent interim XX% prespecified to triggered committee. blinded monitoring data a the the based fashion in be reviewed a patients by was hear study. data on who the sufficient on -- So futility are The you And when to were had the interim of analysis was

We to the They complete looked X arms. across at remain the that information. response rates blinded

we information what no So those about have showed. results specifically

told And also continue we passed. trial of However, safety no new should there were concern that were or we that and without that the signals we told anything we modification. were any

course, that. we were of about very excited So

to and -- forward such reporting to achieve the requisite -- it's bars shared important it's one that of think on endpoint passed the of achieve. I now home an in milestone and that statistical middle we year. specifically the very haven't to final important to data fourth just the point an to the can on it's by take had we be look that primary this quarter that encouraging We details the

prespecified that's analysis your to AML anticipating on study point, in That question, another of will least reporting this at So be including then exciting. And that regard based at third quarter. the out with we're patients. from XX the

realize I And analysis half to have be project important outcomes. that without hard So go, that seen could would the to the be been be update would we're And an actual will trial when we you at the no data, the future. think having will it the that's provide hasn't least of going in that yet. go. have thing we kind It's where with a to seen sharing

Operator

[Operator are the giving for turn further will time. I Conley There this Instructions] Chee no questions call at closing to remarks.

Conley Chee

operator, Please a you and joining reach for team everyone, today have Syros. your further day. great Thanks, of thanks, questions. the us continued if support Great. for Have out to and

Operator

and thank gentlemen, participating. Ladies for you

may now disconnect. You

Syros Pharmaceuticals (SYRS) 14 May 242024 Q1 Earnings call transcript