SYRS - Earnings call transcript Q2 2024 | Syros Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Syros Pharmaceuticals Second Quarter 2024 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 the day 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

you. Thank issued announcing we XXXX second 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. Officer; Haas, David prepared our Chief Chief Jason Chief remarks Roth, will our Executive call by our begin and Dr. Officer; Conley Financial

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

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

should to only call subsequent views represent statements. the would not statements today or any disclaim update representing revise turn We Any forward-looking now Conley? to over be forward-looking any I as as specifically as of upon our date. views relied like any and our Conley. of obligation to

Conley Chee

Throughout of respectively. patients preparation patients is higher-risk laid and upcoming the a treatment care our develop tamibarotene readouts hematologic of RARA fourth us morning. the malignancies. overexpression new half of for Karen, this in MDS gene At Syros, in Thanks, quarters, data and for third you, to AML we've foundation for solid the in our mission everyone, and thank with joining for frontline first with standards XXXX,

NDA we filing diligently approach first our prepare to and working As we're launch. for these readouts,

pleased positioned to advancing thousands launch deliver patients progress of are higher-risk MDS approval, need upon that our in readiness of commercialization am the in tamibarotene we plans. So with to continued I and care. activities our better

we we following we've positioned in our bringing well to concentrated patients As on to through And the track efforts approval. hematology own successful need. opportunity execute plan tamibarotene in points mentioned, to medicines are record commercial the call our given and to deliver previously in patients in new team's U.S. this

closely frontline unmet Both AML believe We to significant. treat. higher-risk opportunity and related X tamibarotene of and provide diseases. differentiated challenging new in opportunity these the remains with to profound a there patients meaningful therapies a significant alter approach unfit in and potential development, are tamibarotene current our the market and There treatment diseases potentially This options. for biologically to is late-stage targeted need paradigm for benefit few very MDS in are need creates

of for currently whose of genomically as a in of tamibarotene AML of are XX% defined higher-risk MDS characterized RARA represents subsets Syros of the RARA and is significant overexpression the and we believe disease patients evaluating is the This XX% overexpression. AML portion population by patient approximately positive gene. MDS patients

in to additional believe Phase address of mid-QX MDS Phase options We to need. AML III a tamibarotene September as significant for data substantial indications potential a half pivotal market to look for better We year with of opportunities, by the and which both patients. work provides these forward unmet exciting we represent II deliver an data second

to over review call With and to upcoming in David me turn our the milestones our programs more detail. let that, David?

David Roth

Thank you, Conley.

time standard high, as Across of selective AML higher-risk to oral tolerability to demonstrated multiple profile. rates, tamibarotene a a new very response of We advancement the RAR and patients. date, potential trials rapid MDS by has are agonist encouraged for our care favorable tamibarotene, alpha complete and response

We used myelosuppression. we even and believe that azacitidine know novel, of hematologists other the easy to and the approach to ability no are We is with targeted, MDS to treatment biologically combine venetoclax therapies oncologists we exactly and differentiated looking for offers with offer to administer with can and convenient like competitive hypomethylating this tamibarotene in patients, and that agents additional differentiation its have and benefits medicines targeted believe what due AML as tamibarotene.

an and double-blind, efficacy ongoing our patients with can in response in placebo-controlled data diagnosed First, potentially with which SELECT-MDS-X tamibarotene of trial of are overexpression. tamibarotene evaluating combination study basis the placebo with the evaluating I'll to compared MDS, RARA trial SELECT-MDS-X accelerated a newly global, azacitidine as trial's primary higher-risk complete enrolled first Phase full together XXX patients, start randomized, durability serve we supporting the MDS in III in for azacitidine. The or approval. approval and endpoint is which, is

Hematologic CR hematologic in efficacy often is low included such is with with improvement, with survival. blood benefit fatigue. as expected is MDS an which criteria because improvement due associated CR endpoint and important resolve counts is patients clinically low peripheral associated Therefore, association bleeding counts. symptoms clinical to the to and infections, also overall endpoint have its meaningful MDS

of clinically secondary potential in Taken continue the patients our including clinical achieving and together, SELECT-MDS-X compelling benefits support short- the enrolling trial, and endpoint key the associated confidence a long-term overall reinforce our are to to clinical with plan of CR our survival.

safe and patients highlighted higher-risk endpoints measure They patients. long-term using benefit discussions, we in the survival. for the of need overall In noted CR webinar care discuss importance that the experts development patients physicians, opportunity they hosted and significant treating in to event X newly all the standard correlated field for transform experience medical agents, SELECT-MDS-X RARA diagnosed MDS In the of of and emphasized with provide distinguished overexpression. these and also to therapies to these accelerate as for new better a the with to tamibarotene the higher-risk for with the novel MDS and outcomes June, approval

first data MDS higher-risk are look and pivotal we later We clinical this from the in observations AML. seen to SELECT-MDS-X date patients which have on year, will build we forward both to in the reporting optimistic XXX CR

to is evaluating turn with II unfit Now AML in tamibarotene our let's newly diagnosed RARA SELECT-AML-X trial, overexpression. patients Phase which

reminder, in this of X:X. As of the triplet with evaluate in regimen venetoclax randomized and azacitidine study combination approximately tamibarotene of safety the compared to venetoclax efficacy is objective alone XX the and patients a and azacitidine to

rate and included analysis, The In arm CR to in alone. X rate treated a response of combination cycle patients initial XX% by with response end of data December as a patients XX% with XX% patients with patients, of arm. the venetoclax and CR/CRi XX and which rapid the in were treated rate showed our to venetoclax compared reported the azacitidine and last with evaluable. the triplet a data responding XX% triplet rate XXX% was a on all doublet of year, the CR/CRi compared CR in we prespecified The whom XX time in azacitidine tamibarotene,

with safety tolerated or Consistent no observations, signals were identified. toxicities ven/aza new was well tamibarotene with additive prior combination and in

the was of tamibarotene's triplet combination there in the Importantly, which of to no standard evidence with potential increased doublet, care. in arm underscores further myelosuppression compared

are sharing additional the this forward expected SOHO from overexpression, analysis the report with RARA at of SELECT-AML-X data with Annual September than in The a data Meeting. XXXX unfit to and tolerability activity we to data update AML more prespecified look and XX to you. excited include clinical patients We're

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

Jason Haas

Thank you, David.

last of second revenue XXXX our recognize million Pfizer. $X.X to as recognizing second of termination did year's revenue collaboration turning the We second quarter Now Syros' results. compared quarter 'XX. quarter agreement to decrease of of financial reflects not in The the with in

related expenses The in decrease the second million as compared reduction was XXXX of external consulting, expenses. reduction headcount XXXX. in manufacturing in R&D of were quarter and primarily the due $XX $XX.X quarter in R&D to million a contract the second to and

and consulting on R&D the G&A expenses, decrease the expenses. expenditures principally focused quarter headcount in in related the facilities XXXX. XXXX second to of of a due of are tamibarotene. million as Our $X.X to $X.X million reduction in and was advancement second were compared quarter The expenses primarily now

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

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

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

Operator

Phil Instructions] first from from is [Operator Nadeau Cowen. Our TD question

Philip Nadeau

from A few us.

a see think the XX go/no-go in you on make data do sufficient? AML? study pivotal decision you'd Will want in in be in tami September when advancing patients you in First, position from we patients the to all full AML, to would see into Or a trial? a be XX

David Roth

your It's Phil. here Thanks, David answering question.

who listening up. are make are to just sure, caught all So

Oncology from on the planning of place update trial. SOHO September. prespecified ongoing are in on at We analysis that's providing upcoming Hematologic an a Annual the SELECT-AML-X data That Society the our take in XXXX Meeting of will

that available slightly XX-patient analysis at total XX to And larger analysis since will is contributing include who point, to, intended prespecified the milestone cut the enrollment of a point. continued at have the patients are patients beyond this least likely number

In data. to and terms I see of -- knowing we go/no we go plan, think really the timing need the sharing the what for the

understand show the better then for be it's the next We across the to what haven't comparative out. us to us them analyzed going and they are steps X and what results to communicate very for plan, important arms,

appreciate bit with that, to I it's answer can. as provide you premature soon updates your as question. me will, directly we So we hope for a and as always, you

Philip Nadeau

type to else delta And could a what to move decided -- us see on of you sense the arms want that's anything decision? pivotal, what important or to would give between of you your to in some

David Roth

last rate XXX% showed CR/CRi at included as the you we a of high CRs. presented a Well, rate, which know, year that end of data very

of arm think and a of the XX% XX% I it control were CR. CRs those that to CR/CRi compared with XX% rate was

very of response. complete obviously, response CR/CRi well the -- were we magnitude excited So the about as the as the complete

of their arms those in way quality and which between to responses be interpret duration understanding remissions, contribute of in will those results. also X terms difference about the going those to something the the we The all of important is

in are provide have the them, you'll understand they So again, better September. we'll how for at to what we We'll share point help in time. able and that interpreting data be and we're and them context interpret what have the

Philip Nadeau

second, then And helpful. That's on MDS. Perfect.

plans the there in overseas? for marketing the about to us remind to on you Can Is Europe? clear very your been commercialization would You've And Europe? what path path U.S. drug here the commercialization be in a

Conley Chee

Yes. it's as The believe efficient more focused, U.S. that building In us will market we you and very to much an the fragmented. know, infrastructure commercialize continue in to Europe, is allow U.S.

is to And so to license or the partner find that. idea against in a execute Europe

Philip Nadeau

last then question And Perfect. us. for

that Just rate, Was been expenses we expenses. have on quarters the were down down? in like cost-cutting timing Or that be that looks cost-cutting expect this quarter. it to of run this expenses past? -- future some expenses Jason, minor the new taken initiatives some to more initiatives have the there financials. similar is should the And

Jason Haas

down focused all Phil, the year to as kind prepare I've commercial this and AML and resources to mean really the have later starting expenses data we and year. on reprioritization data mentioned been once we then Yes. did point, launch of data are last MDS a for coming our this late I getting before, of at have because

rate fair for on at say to this at it's reasons we're years We're think of where pretty in expenses to past. run point. a on new expenses I being we So relative judicious were obvious kind

Operator

will Our Ed second Piper coming be question Sandler. Tenthoff from

Edward Tenthoff

a just And the Really achieve maybe see is needed on Phase -- us what weeks SELECT-MDS. the question give to III you is ] [ power this of enjoyed My a reminder do trial? us you that. couple what out. Remind delta the can for

David Roth

is Ed. David, This again. Thanks,

XX% difficult little powering based the powering for modeled over our rates rate what you to difference what CR to the primary remind in your arms. assumptions is the show but X CR you were and I and question, think powered -- endpoint We've the a SELECT-MDS-X, the to is X:X on If Phase III. hear, a the was it asking study The the was randomization. across to

this middle patients patients. quarter year. of the we that we're of power numbers We XXX the achieve is the fourth of the first And primary that the need approximately accomplished back enrollment pivotal quarter, by to in anticipating about readout and having

really excited that. we're So about

The assumptions And between around into took is arm. significant we've the we performance those was consideration. how for for the there arms assumed the what difference standard would control perform, aza

haven't not there's goes but assumptions. that the the numerical overall durability final that We the in only and of mind publicly But safety. into other CR, includes response, of things the the disclosed lots keep the secondary readout, which endpoints

I have that success at much able So interpret the great as as remain able being think you'll share as we we we'll to line, of trial's the our to be anticipate time and in ultimate we top context hopeful. can

Edward Tenthoff

Great.

Looking forward SELECT-MDS the data in to the of quarter. middle in the fourth

David Roth

correct. That's

Operator

question from [ Citizens next coming ]. Our will Butler JPM Jason be from

Unknown Analyst

follow-up data? for on on one Citizen's duration from Roy Jason have at What going SELECT-AML-X, for Quick It's SOHO. update that of JMP. the you're to

David Roth

capture least least enrolled to reporting study will at patients. prespecified a XX% be planned XX excuse analysis the of analysis. So targeted prespecified -- XX me, We the on at that

would be a was the likely report the XX. larger subsequent than ongoing forward analysis time data we the enrollment at at So having number trigger gathering. the will to for There prespecified because to slightly XX look least of there date

of the September time all are these in of that be terms were in on parts the study, details presentation. length these will forthcoming And patients the of

from obviously, have in a will we earlier opportunity the were who much the the patients year, study enrolled but time. recently -- at part reporting the So be who are those will back provided as update we was be had the followed that can of in to relative as more to initial larger

Unknown Analyst

on SELECT-MDS-X. couple And then a Great. Okay.

or just target have you for target forum update a status patients survival You XQ? presenting analysis? for CR in And give results us method the an can enrollment pivotal for a the

David Roth

the corporate sort. trial from middle the So be results of we'll in fashion would of placebo-controlled by blinded sharing ordinary some top be communication randomized line obviously, a learning the fourth as as it about that the we'll quarter, the and be,

sharing, time, We haven't specified certainly we you but around information additional much any nature at the of that or provide as presentations with data can. we'll

trying seeing, and I to point. excitement secondary good progress the total are obviously, XXX toward the continued has patients And continued enrollment the target will making for the what the say for endpoint study we delivering we're since and say analysis. we of end great interest in achieved enroll, the program is I'm to and survival primary

of completion or information enrollment we timing haven't of provided on that yet specific analysis. said, That the that more the of the timing

know, As it's an endpoint-driven you analysis.

to specific And analysis, at we come so obviously going later a than in point time yet. it's the but CR haven't more been

Operator

Cann Our coming next Leah Instructions] Capital Brookline [Operator question be Markets. from will from

Leah Rush Cann

I'm for and us is question My you can David. give hoping around framework MDS. some clarity

we appropriate characterize those high-risk the endpoints present them? difference how for patients, about can and them treating are you patients the think patients versus in as So studying the and what low-risk

David Roth

Leah. Sure, question. that for Thanks

defines lower think could into the what higher divided you is, of risk categories disease lower-risk the is risk. Really prognosis. the So of is patients, X patients and

more serious evolve time have into a a life-threatening they horizon longer disease. they until much So

closer So in point time. the higher that to risk patients are

the we get the Prognostic was what defined Scoring Details that general, Greenberg to risks in look specifically. that by you out certainly want are So if Blood. International by can published more you IPSS-R, revised which System and information are, those and and to the

In will symptoms are a anemia. cytopenia that related general, And with. that's the patient patients the present of those prominent to low-risk

fatigued and anemia, do and dysplasia. they their diagnose to and often being looks marrow but unusual blood and they'll they come doctor of weak the they complaining So have a

largely red And the cell blood then and directed are treatments aimed improvement. at

increases, associated some just more have more is the with disease, disease specifically. you when AML. and would hemoglobin on, looking be of So like endpoints Later concentration high-risk the

in they're very similar are As diseases you on those respect. a continuum, know, that and X

other impacted And of relate platelets. to the bone that counts and the marrow levels the in increased there, problems so blood cells blasts are like white

as may those So be well with anemia they patients have may like as AML bleeding, associated having or difficulties symptoms. infections

is response particular why And the largely rate, are complete that endpoint. focused which the so therapies on around the endpoints we chose there

a overall it with development correlated provides early for know, drug. efficacy As important you a read closely survival. very of MDS CR drug on endpoint is because It's the the an

very of improvement Hematologic a definition. is the endpoint important aspect

So improve claim you the the as platelets, when the reduced. white long then CR in you as count, count red you a blasts have can have been

also survival. are an a symptoms to would why of one which -- resolution of CR patients benefits infections, that bleeding a associated, expect fatigue. the benefits So have, And with long-term that's lot short-term these attaining a and and there's that

a its in the decision. of why supportive making that's And use regulators are regulatory

So hope can and that symptoms fix them. can get about and when excited patients talk we their to I to I And as I probably your helps the how very answer a question. have tell, disease chance you

we're to So have more in you happy any if future. take the

Leah Rush Cann

infer their And the here that, patients is trying helpful. down. just make on with high-risk blast that I what Most disease, from track I'm to you're right sure would get count to

addressing with and very be you'd but sets than these blood a lineages, you distinct mechanistically, Am really hemoglobin it potentially of So other the patients. different I a where would patient, for some primarily very you're supporting, low-risk disease paradigm right? would differently X treatment be

David Roth

have I going time. largely with leukemia, have symptoms. the at the be of But the increasing the to to a patient with think blood why are disease cells a problems the red some you the treating and that red may They're cell ameliorate anemia. without a the low-risk development you before to promote problematic of ones a not There's therapies of that that's count. associated fair it mass clone you're leading are There's going causing but it. view low that to the similarities are reasons way always delaying what

Operator

like call closing further to are over for no comments. turn Conley Mr. Chee I'd final the questions time. There at now to this

Conley Chee

today to if second forward to and questions, looking year. the joining out operator, for great very continued thank all your We're And and day. us. reach questions. Thanks, a the again us free please thanks, And feel for great all have half of any Great. everyone, Have you for a support. exciting you to

Operator

participating ask conference concludes for gentlemen, that your and We for today. and Ladies please call this thank you your you disconnect lines.

You good one. all a have

Syros Pharmaceuticals (SYRS) 31 Jul 242024 Q2 Earnings call transcript