Earnings call transcript Q4 2022

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Operator

Good morning, and welcome to Syros Pharmaceuticals Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. 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.

Karen Hunady

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

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

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

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

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

Nancy Simonian

malignancies. year in and of treatment everyone Syros pursuit morning, hematologic XXXX for meaningful standards deliver our joining a you advances new the Good care thank Karen. you, Thank frontline we for to made towards of today. marked for which important us

commercial are patients' quality own synergies with address business attractive we markets AML believe maintaining APL is well-tolerated need diseases in that through plan MDS, clinical treatment in outcomes, MDS, in our for late-stage of more efforts are we which and AML programs the to and Today, APL, on that options still while and improve US. convenient our that three We significant there focused life.

year December, portion we into past data quarter. II our programs. in enabling In safety the lead-in of randomized the the reached Phase us move of our heme study positive announced the Over study this we SELECT-AML-X milestones portion important from to

study In data if believe August, efficient are go-to-market which dose data additional could confirmation we promising we SY-XXXX, supportive, enable from of our preliminary an announced strategy.

progressing continued enrollment recent and across trial. SELECT-MDS-X the we've momentum ongoing We in sites. pivotal global months, activations And our seen site in

the patient in were And January, to for treatment higher-risk Designation receive we underscoring critical new MDS, population. Fast for for this FDA for options delighted Track need the tamibarotene of treatment

that December Blood term our I to December, also another pleased scheduled end year with extended XXXX. announce in collaboration we Global the to am Therapeutics in for now with

financing the we addition, the and In million which approximately XXXX quarter our of $XXX runway of with in cash our second close September sheet extended secured our we capital. in strengthened balance into successful XXXX

our also Importantly, portion our pre-commercial trial Phase requirements trial, past to begin SELECT-AML-X III important we while data the randomized believe the of bringing to SELECT-MDS-X market. proceeds are these activities the therapies data cash from sufficient and allowing in to in investing from us fund

look prepare Together, these catalysts. and as for accomplishments foundation, upcoming provide we a tremendous ahead multiple

SELECT-AML-X a in registration second third the in the Specifically, XXXX. randomized the share on in in XXXX pivotal of in trial, of Phase pathway and of update share additional we to steps We quarter in to data data from SELECT-MDS-X expect initial XXXX of XXXX. on and and enrollment the fourth by III an the study announce dose confirmation of complete portion XXXX, data quarter followed the APL, next quarter And the trial, half XXXX. fourth the of

David, call detailed programs. on update our the turn to to like now ongoing David? provide clinical more would over I to a

David Roth

the through update on an and XX walk Nancy. anticipate, the months. provide over you, Today, we Thank clinical pipeline upcoming I'll readouts our next stage

I'll First, in tamibarotene MDS. begin with

Designation tamibarotene, treatment people pleased Track delivery As grant to are us of standard Fast recent care Nancy a by the we with expedite to new of FDA's disease. tamibarotene, of for the as living the this higher-risk for the opportunity decision progressive to potentially mentioned, MDS, allowing

to As existing we've and approval HMAs response of nonclinical discussed or of approved, before new a have treatment since diagnosed drugs need. MDS new hypomethylating of care today, XX.X patients, Fast median for address data, help grants a been Designation have available agents, The no significant clinical XX% limited demonstrate newly the therapies survival XXXX. beyond And complete options. only medical higher-risk FDA months. unmet The rate potential to standard Track which offer speed the a

frequent supporting including discussions, candidates design III reiterated decision-making the that well with more FDA support interactions Therapeutic as approval as with has complete review if and our by data an of Track durability In for clinical its as regulatory eligible may on the recent data. using Phase agency, remission. Designation, priority supported along be appropriate received rate, endpoint for accelerated for response Fast

We are sites. continue in now recruiting our of. SELECT-MDS-X at frontline to aware trial, only trial, actively the We encouraged by physician higher-risk enthusiasm over the XX and open have in are XX see activated steady MDS pivotal in we sites registration-enabling progress clinical countries, that we

quarter pivotal this enrollment the to sharing continue the and CR We in XXXX. forward complete expect to fourth year, in of third of data quarter look to

is survival turning rate has of age and AML a XX.X patients, chemotherapy, unfit our Now XX% overall median eligible Azacitidine condition. months. study AML ven/aza, intensive for Today, not approximately to Venetoclax the for of an who a which underlying their of half with CR shown AML to are or medical in standard due or unfit or of the patients tamibarotene, care

safety patients median newly a ven/aza relapse. very of only showed the from combination respond do months. in diagnosed a December, these showed not X.X frontline overexpression, increased portion with announced includes unfit positive The in tamibarotene At ven/aza, approximately have with patients study. one-third of of triplet and population. of this of evidence with AML historical lead-in patients all prognosis nearly approved survival our Unfortunately, when onset and SELECT-AML-X relative RARA combination relapse, This rates doses The with XX% tamibarotene aza, overall we poor data rapid data in action. CR/CRi ASH they ven/aza data rates doublet to that the no demonstrated of ven rate toxicity, combination of of and an in of with to also myelosuppression. And

the portion in XX with in So combination of XXXX. look to of into additional evaluate we SELECT-AML-X randomized unfit composite of of data initiated based the primary study, on RARA CR the to year. of the safety is data, compared designed this tamibarotene, X:X approximately first XXXX we ven/aza, randomized these rate to overexpression randomized point. We portion AML newly ven/aza in the efficacy the with from diagnosed The trial and portion randomized the in which quarter fourth initial the announcing and end forward patients of quarter data trial who the as are in with moved

of turn EU frontline with X,XXX IV to novel ATO currently APL is being or our arsenic in US oral XXXX, the I and dose annually. APL. oral people an study of trioxide of form evaluated for standard are Approximately care ATO, confirmation combined ongoing treatment diagnosed Lastly, the will current in the with ATRA. And which is

a two patient, to While burdensome to effective XXX IV for over nearly hours ATO infusions involving each the four year. up is treatment for very

both ATO is an reduce oral reducing therapy We all believe while healthcare XXXX exactly We effective an this allows a significantly quality increasing costs also life. patients utilization. oral that could regimen access for burden could better offering provide treatment of and and believe this and

confirmation the in progress We're making study. good dose

update As both Based We may Nancy be August, pathway registration share to we second we these next opportunity confirmation Cmax this on announced half exposures and to AUC. in to and our ATO mentioned approval. study potential with efficient on steps there high emerging more trial the of on XX% of data, on explore dose registration pathway initial data demonstrating bioavailability the year. from approximately plan IV an believe based an a oral to comparable in the

and advancing our dramatically patients. programs hematology the pipeline. We're through programs, to all with development, three care to excellent lives the of late-stage we progress of make to each potential become standard In continue improve across

this look additional to We forward updates providing upcoming year and have and next, catalysts soon. multiple

like call fourth over our the and review Jason Jason? turn results. would quarter to to to financial I full now year XXXX

Jason Haas

Thank you, David.

fourth to and year turn results. I'll quarter our financial full Now XXXX

As our December Nancy extended past Therapeutics, collaboration mentioned, we agreement Global this with for year. Blood another

at As a of agreement the extended made that start upfront period us the to the of in payment we result, XXXX. GBT the amortization

the to required negative one-time the $XXX,XXX a we the us GBT cumulative in true quarter. of collaboration from revenue up revenues to This quarter. catch-up recognized Therefore, in make fourth recognized fourth adjustment the

have we continue in past. will recognize to we from XXXX, revenue the as GBT the For

collaboration For under million year, of the with $X.X GBT revenue, our million and Incyte. recognized we in our full consisting $XX.X collaboration million $XX.X with under

XXXX quarter XXXX, of million year the Incyte. For $X.X and our total GBT a million collaboration from revenue and of fourth with respectively, $XX.X of we full and recognized

$XX.X for expenses employee-related full quarter fourth associated million costs advancement increases year for XXXX full the the of the XXXX the expenses. $XXX.X of of were with clinical programs year XXXX. primarily quarter full million and compared for for as million R&D $XX.X the million were in and year to fourth $XX.X fourth and quarter of and increased Both due our the to the continued XXXX

the the preclinical that million the expect as and $XX compared R&D for were expenses, discovery current million million $XX.X stage and XXXX quarter fourth be our by programs, of to operating the on our to $X.X full XXXX reimbursed year drug XXXX partners. Based our $X.X relating of year quarter our we in XXXX. will full future G&A expenses and fourth for for million collaboration plans,

allocated accounted consisted TYME past acquisition expenses former with that severance following issued as TYME, the $X.X XXXX. of million warrants closed of paid in to for for year, which PIPE incurred to the financing Transaction-related were of cost connection September employees in liabilities this and primarily our

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

$XXX.X of ended $XX.XX compared million and million securities for equivalents Syros share, Cash, of in the with same net For year $X.XX to XXst compared as the cash XXXX, a loss of $XXX.X at net December marketable of period December or XXXX. end XXXX. were as full or a $XX.X the million per XXXX XX share $XX.X million loss reported per

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

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

Operator

now TV from Philip ahead. the Please comes Your question and begin gentlemen, from Thank you. question-and-answer go we Nadeau first [ph]. Ladies will Instructions] [Operator session. Bandra

Philip Nadeau

on how first, bit us, Hi. data in the many Good from talk that the morning. that Thanks A taking quality a my questions. you Approximately you more release much think little how at able patients can willing from with, you'll for be in about disclose? time. endpoints follow-up what do be to data SELECT-AML-X couple QX, to you'll of

Nancy Simonian

Phil, that. take to ask to I'm going David

David Roth

Phil. you, Thank Sure.

we've enrollment just of reported of the anticipate randomized trial out portion reporting randomized the as initiated data the So study. we've we and the into of portion coming

be We would that haven't yet specified the total number patients of available.

balanced mind in be will two of randomization one-to-one the Keep into arms. each it

going patients to So context very good insights expression, provide interpret of doublet to with important as combination the it's over in data. be we have how look the performance versus RARA to who to getting forward the into us the triplet to

and we'll is available how and to usual rates information report understand working. response triplet available as any the help on And continue other to the safety durability

So update. is forward important look we to an presentation data all I should think that

Philip Nadeau

designs registration on maybe of could could That's second discussions you what the some think you you helpful. have approval after a efficiencies with efficient type path XXXX FDA? possible with of share more you then, And realize to us do

David Roth

no. is, So -- answer the just so

We options. haven't yet disclosed specific alternative design

to me give into I think But comment fair that. mean, for I for that. some it's premature you to me on it's insights So do

to IV and As of demonstrated regulatory arsenic. historical we coming important relative data we the we agencies vetted out initially designed that encouraging which with which with had global data really Orsenix the study exposures

in versus oral the And ever we first are test really patients directly the to IV.

the provide appropriate to PK hone a so And collected in data evaluation to exposures and that on properly support dosing. could really the

AUC last has year later and data what It's that all emerging dose encouraging strategy. That's that and shared outcomes really earlier ways have really confirmation is new supports development been based on that as both previously of that And a about. supports to this about how bioavailability last we streamline we the year thinking study. high Cmax

is the data. we're patients all to delivering guess, bringing as And I or possible. about And could streamlining this forward shorter that's mean quickly what times fewer as

forward second you giving specifically have that without things. you of you'll So think, thinking insights in we're more year. about look how update And I half into the great the to could details

Philip Nadeau

questions. helpful. Thanks our That’s for again taking

Karen Hunady

Phil. Thanks,

Operator

Thank you.

Breidenbach go comes Mark Your ahead. next question from from Please Oppenheimer.

Mark Breidenbach

Hey. Good questions. taking Thanks for morning. our

of Just for me as couple ones a quick well.

can all, just And you housekeeping the analyses could SELECT-MDS-X remind wondering, in question futility second year? is now. has stabilized top-line us now quarter then between count into see I'm and just of third built share protocol if the if First next for there that any data of Jason. we the

I in think or with settled it's is the taking the of around kind TYME? around to Thanks that much following for there number XX.X the questions. million Is XX-K. it fluctuate expected merger

Nancy Simonian

Hey, Mark, I'll take the first one.

not guided any expectations futility, analysis. for futility to on So have the we

pivotal in XXXX. CR I focus third So of really think the be on quarter data the the should

Mark Breidenbach

Okay.

Jason Haas

Jason. it's Mark, And

we ought count have stable. relatively share remains basic million and XX.X shares to outstanding that the On

X.X also million We have prefunded warrants.

I share total XX.X count outstanding. our of a way is million the about think shares would So

of investors round and numbers. shares XX.X into ought shares to the those who prefunded, we'll number remain but the took common in at aggregate the warrants between So constant the to extent different some the distribution common million convert relatively have prefunded of a warrants just

Mark Breidenbach

Understood.

That’s helpful. Thank super you. Okay.

Karen Hunady

Thanks, Mark.

Operator

Jason [Operator ahead. Securities. go comes you. Your Instructions] from Thank next question from Butler JMP Please

Jason Butler

for Hi. Thanks also. Two me questions. for taking

about us path, can Just have plans year? we -- would this with an get score? patients you And monocytic FDA support talk the not stratifying remind you before XXXX have potential on with that had expression interactions you SELECT-AML, then the to you're what you if if later already update can interact expedited just for or FDA for Thanks. [ph], by

Nancy Simonian

related And So to XXXX. David was take I'll have the just question first. to the clarify second

Jason Butler

Yes.

Nancy Simonian

Yes. any? Okay. David you had

David Roth

So AML, with by... you're what the respect asking is the about trial stratified to AML

Nancy Simonian

on based phenotype. based any -- the selection selecting monocytic Whether on

David Roth

No. Yes.

the II report We The we the at we we going all test Obviously, saw to for positive. not. six ASH recall rate, you the we for diagnosed XX% we're and that very the be at consistent was newly going time us are data patients of at to provided encouraging. be that's that RARA using and the of really presentation same -- design CR/CRi score activity. Phase they we've we have used are unfit So with criteria important original overexpression that collecting along. looking evaluated evaluable who correlation. And that the understand which five had an monocytic were from may the patients had who clinical were did And of to expression four

analysis positivity XX% prior was for the which again that's rate So spot on II. the Phase from

we to So you of across an consistency giving data year. later reason look update this forward to have and trials predict the

that we us the asking -- communicate specifically. that with that I second XXXX what you development ordinary And our we it's But year you're trial, will the forward in think discussing to the think I discuss the to we've regarding then little to the globally half make part of with if give respect steps. plans regulatory our interactions for we premature of path. on look be a sure regulators in do more on clarity the haven't we're had We our to next disclosed right of course

Jason Butler

Thank you. Okay.

Operator

Thank you. questions this further There no time. are at

may You proceed.

Nancy Simonian

Please Have reach Thank of your and us Thank out us a everyone look and further day. for productive continued today. you, forward you with to Syros. operator. joining ahead any an thank you year support exciting We to questions. for great

Syros Pharmaceuticals (SYRS) 2 Mar 232022 Q4 Earnings call transcript