- Earnings call transcript Q3 2022

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Operator

Good day, and welcome to the Q3 2022 Syros Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]. today's being that advised be conference recorded. is Please turn over to would now speaker conference to like I your the Ms. Karen and Hunady, Investor Communications Relations. Director of Corporate Please ahead. go

Karen Hunady

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

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

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

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

Nancy Simonian

everyone thank Karen. you you, morning, Good us joining today. Thank for and

these transactions oversubscribed In targeted quarter also development the Together necessary netted clinical close to late the in with merger million, providing supporting of announced and September, Technologies our for hematology the third launch $XXX we Pipe our The us TYME while concurrent initial transformative Syros. readiness. cash was investing programs, financing. our of continue approximately stage

always believe additional an of closer with Our ultimately foundational portfolio are to cancer. vision into living important With we to capital, has been to a build delivering this we achieving company. people step commercial medicines goal this Syros and to our

Now we data Phase I'll announced ongoing morning the lead-in turn initial SY-XXXX. the evaluating portion of trial from this safety our to X

potentially treating achieving shortly and exposure most continue well yet partial or in of tolerated provide combination same difficult-to-treat inform evidence As to with remission. a will pancreatic these the X XXXX single therapeutic strategic from both best approach combination David by is one a said we've agent will the gemcitabine. evaluated for data XXXX's with trial the a by safety a disease data patients for always course We've patient of the reached single relationship cancer further and pancreatic own tumor other clinical profile dose priorities of single difficult-to-treat plan escalation review as achieving emerging malignancies important given the At time, further that the our program. combination context dose CDKX the this in a agent development doublet cancer agent Phase as as inhibition maximum this response stable in with We're emerging types. several activity one that and and and devastating and confirmed both observed we've encouraged as in

types. tumor cancer an opportunity the update we that opportunities best time difficult-to-treat who providing, solid done We pancreatic to this in tumors, to maximize the is end, as be and while has partner forward we While at strong the in we To believe combination in regimens of there resources appropriate believe will a rationale to escalate. to well hands as in plan as look the continue both as advance cancer a dose explore XXXX pancreatic the well partnership to we in additional other future.

are to continue support excited evaluating in in mutant arm, intrinsic BRAF patients atezolizumab ongoing XXXX in with we colorectal Importantly, to Roche's cancer Phase I/Ib their with combination trial.

Turning to portfolio. our hematology

RAR-alpha of who to and overexpression. know, our positive you the selective be for are of MDS care RARA new approximately is potential XX% to has As XX% tamibarotene standard AML oral potent patients, agonist, a offer of gene which and

SELECT-AML-X newly higher-risk evaluating currently in Phase are unfit two Phase in patients; III patients. in and in trial tamibarotene AML trials MDS diagnosed clinical III trial We SELECT-MDS-X,a pivotal

SELECT-AML-X As week, Meeting last we Annual sharing the be portion will data announced in trial safety-leading in the at of ASH release December. we early a the initial from press

from the meaningfully presentation request the forward alone for patients excited We trial, outcomes existing for trials, MDS AML together by with standard trial augment for initiated a We now overexpression. XX. updated with the prior with activity our on encouraged We are in look our We ASH the supports AML initial any from from data II and presenting with SELECT-AML-X which based reported in study clinical and which patients. And and December care and anti-AML highly has outcomes questions azacitidine SELECT-AML-X the clinical at we venetoclax until on potential the belief data data Select-MDS-X improve you onset both improve and with from agents save overexpression, RARA date. this newly observed to MDS the that both rapid higher-risk to a our that tamibarotene on combination trial to showed trial, to tamibarotene hypomethylating in potential with rate patients with CR/CRi and of are SELECT-AML-X diagnosed previously by data of data Phase II Phase RARA tamibarotene high action. early the and

of the to data XXXX XXXX SELECT-AML-X portion XXXX. the randomized SELECT-MDS-X or Phase pivotal with from in Looking or early in II initiate we continue to trial, ahead, and expect the trial, XXXX data expected late

progress the patients, frontline of are confirmation of trial with our or in form acute dose ongoing promyelocytic good and of In addition, making or novel treatment APL. leukemia our SY-XXXX ATO oral arsenic trioxide we for

and track to identify advance to as of expect planned on call, in in based on And XXXX, feedback EMA, announced be and we both the we from into our single III XQ second to our next will the approval United to initiate support which a we year. on trial, the trial believe are use we FDA to half the dose of able States the Europe. both optimal We Phase registration

will mission excellence, to new over us to catalysts the of we our difference standard clinical of which potential each each and are of our candidates medicines to work in execute and redefine our ongoing enable And towards across grateful patients to would and of these for new forward our by in with We making bring the we lives. that care like product a confident with our for are upcoming studies. We David. profound David? continuing of investors, to forward patients' our excited turn difficult-to-treat the the tumors. ability existing call believe to of look now support I

David Roth

data potent I Earlier oral selective with as this the is patients combination portion cancer. Thank will XXXX, which SY-XXXX. of focus safety inhibitor we on ongoing discussion initial safety chemotherapy, from relapsed/refractory announced morning, I you, evaluating data clinical our and my CDKX trial our lead-in highly activity Phase well pancreatic in Today, as in early of Nancy. with

a difficult-to-treat the provided Today, combination most the cancer, Orphan in one Designation therapeutic second-line develop our the is progression-free patients, the tumors treatment the In have of single-agent pancreatic also advanced intervention. for approximately patients. offers otherwise of underscoring of ongoing urgency cancer we Pancreatic Onivyde malignancies. from from to September, for X-FU/leucovorin, We is solid and of Drug devastating US data for eluded updated three the portion FDA approved XXXX median trial XXXX tumor for only which agent with in survival pancreatic months. whose received cancer pancreatic

doses with patients, in FOLFIRINOX. gemcitabine treatment tolerability, as assessing combination or or in study and pancreatic rate enrolled a reminder, XXXX XXXX progressed first Phase and with being to combination with I in receive the in evaluating first well who nab-paclitaxel as survival. trial The combination As efficacy the measures, control such and agents. is progression-free chemotherapy relapse approved of at our disease cancer XXXX relapse following safety either as in are gemcitabine in Patients with second is combination

As earlier, we the we're data by Nancy mentioned encouraged shared today.

of with First, in both on and as safety XXXX, a characterizing the and tolerability chemotherapy. agent single combination

across cutoff, gemcitabine with agent, administered safety profile milligrams, DLT XXXX nab-paclitaxel. were common gemcitabine the single tested. we've DLTs or seven-day evaluated evaluated in one be and with the XX We are grade, and administered on treated five not patient milligrams at with being XXXX in maintained highest report, combination level. XXXX, XXXX milligrams in regimen. in and four yet when observed observed up one to with all the reached at the enhanced when nab-paclitaxel. in seven-day been majority generally of fatigue, to that a level. XXXX a seven-day on, XXXX date, highest profile in safety result arms This and milligrams Grade regimen strategy study, MTD or adverse the included related with not to off October evaluated doses three any XX Across diarrhea And off identified. nausea, event to with reported appetite, XX administered combination To of in ongoing development gemcitabine as new decreased the XX DLTs, experiencing only up to was to up regimen with with was doses platelet promising dose DLT consistent from the further as XXXX I now trial, adverse very No both underscores off levels, grade were count, single-agent resulted intermittent five our The with chemotherapy, events did nab-paclitaxel. allowed low importance were careful dose has a monotherapy adverse describe the seven-day the in all dose of dose, dosing gemcitabine, at been tolerability will of The single-agent the and of most with has cohort no patients decreased reversible, in four-milligram five-milligram seven-day signals the that advances seven-day in The XX-milligram agent the combination that of our an with combination of of patients low in our with of XXXX for which now. four regimen, supporting on dose optimization tolerability where and when at events an in chemotherapy pleased as single safe gemcitabine ranging gemcitabine the

Turning now to activity. clinical

patients patients including cancer notably achieved patient had not stable overall to of dose partial of data patients were for with a or X-milligram cohort single-agent two one impressive CA doublet XX gemcitabine experienced of or with a response baseline XX-milligram reduction. the PR evaluable, and four XX.XXX October is marker cancer an FOLFIRINOX. Both of confirmed XX%. In an pancreatic Three colorectal As XX% XXX tumor treatment the rate was one dose patients pancreatic control also a response disease per XXXX with with responsive evaluating cut, a patient in per and with of experienced patient treated cohort stable from in evaluable to three in XX% disease treated of XX% at cancer. the XX-X enrolled XXXX milliliter reduction level response which patients four the response evaluable and considering units this tumor pancreatic of prior cancer, frontline the level, the or of XX% the units SY-XXXX milliliter, of at disease four-milligram combination with one

gemcitabine and continue combination and higher to in patients, achieved milligrams dose level. gemcitabine responsive in our support of XX XX than one patients, us The relationship. the dose to stable an two at XXXX a PDAC Importantly, that nab-paclitaxel of and to as disease. the doses the emerging and achieved dose characterize with doublet, the evaluable on exposure cohort of to the patients confirmed average milligrams XXXX to triplet data dose response X-milligram these the exposure resources exposure Nancy index. to In who therapeutic patient response other our parallel, to opportunities from devote activity demonstrated enhance to single leveraging emerging agent mentioned we evaluating higher cohort, a at relative in programs. of data escalation cohorts will hematology plan XX-milligram partnership we level treated doublet earlier, better the as relationship hopes combination to In explore Based PR, allowing late-stage from advance patients single-agent and to clinical the XXXX

at As Nancy potential alluded to look treatment frontline and of to across call advancing SY-XXXX the progress ASH to our as to now December therapies quarter third presenting MDS, care of with AML to would SELECT-AML-X review our hematology Jason? our I standard details tamibarotene and in there. we making data initial tremendous financial earlier, for over sharing turn you we're Jason like additional and the We where portfolio to forward APL. are results.

Jason Haas

David. you, Thank

operate our approximately Life These secured planned past Technologies, we Track of Concurrently, investment Finance through transactions In expenses Syros closed Healthcare with net amendment oversubscribed Capital, announced $XXX to Adage, raised and through shareholders operating our life We financing, previously $XXX senior Invus, loan PIPE continue new We pipeline as equivalents, Pioneering, Oxford runway. and we closed was by Bain with with expected Capital capital its will approximately including and Samsara, and September, the Investments. cash from million. financial which position and our we Sciences, quarter in such our and TYME believe Flagship facility our ended cash led a Deep PIPE we into requirements significantly Cowen acquired Avidity strength. existing with readout fund extended sciences-focused of Bridge which which The Partners, pivotal be million merger the XXXX, million. funds together third SELECT-MDS-X. data cash we to year to TYME, assets approximately sufficient $XX a for our included expenditure cash Ally

financial consisting to quarter XXXX, recognized and our collaboration results. the $XXX,XXX turning our third third collaboration with $X.X revenue the million $X.X quarter of in in We of from with from million Incyte. Now GBT

$X.XX with were quarter of decrease was third of recruiting allocated paid of primarily severance were recognized in PIPE liabilities fees. the our increase and XXXX. This preclinical XXXX R&D million an quarter to in XXXX. employee-related warrants million million expenses expenses to our GBT of G&A quarter million classified quarter for to were in the $XX former XXXX, third expenses to TYME a employees. financing, decrease in $XX.X in $XX.X of revenue XXXX. the was to share third for XXXX the net programs. attributable a the third which an relate This loss for We Transaction-related in expenses expenses primarily same million quarter reported costs third in $XX.X million share of a third compared of external $X.X $X.X of per under third compared are we to the to These quarter to million with the the increase and quarter net or and the principally associated $X.X million period compared $X.X loss XXXX. attributable of For for or collaboration $X.XX Incyte. increase per

million close the approximately which XX of shares as Finally, we following with and the split, we well the September, XX:X the ended reverse common merger transactions, that, PIPE to to stock. as stock quarter in and XX.X questions. warrants. of for implemented the common pre-funded turn I the This pre-funded of $X.X warrants With million stock call million shares operator stock includes over and will purchase common

Operator

Thank you. the first Tenthoff Our of will [Operator Instructions] with line Sandler. come Please, from go question ahead. Piper Edward

Edward Tenthoff

you Hi, more can looking us guys. -- if just to there? of see all on give expectation expect Thanks. for Really -- a what data kind and forward the should the of we wanted what little Thanks to much the update congrats at of bit hematology of to so progress. an

David Roth

Thanks Ted.

we'll take more around able has about you presenting give and the the we're upcoming very ASH further forward at show. in Right dig that So time. context planning to at be updated and questions now, and to meeting, to data a excited to color looking presentation that lot about when presentation what we're we're the

Edward Tenthoff

the I to And said happen? could Great. Phase initiate portion. expectations in think as When X are release, you that Thanks. press the

Nancy Simonian

phase question Hey, think think was your around -- I portion. the I randomized Ted, the cut but out, you

So we're –

Edward Tenthoff

Yes. Thank you.

Nancy Simonian

yes, of on the steps ASH is Our provide plan with to an provide update the at -- kind to trial. next

Edward Tenthoff

Great.

you to Orleans. forward Looking in New seeing

Nancy Simonian

Ted. Thanks, Great.

Operator

will from line Philip next Our Thank question come the you. Cowen. of go Nadeau with [Operator ahead. Please, Instructions]

Philip Nadeau

the of ladies Good progress. Congratulations couple start. on on morning, gentlemen. XXXX questions A and to

you MTD? hope the disease do or sense in control hit us an both this some to give once that that rate you of response to background you confidence over population and define monotherapy therapeutic give in XXXX. better mentioned index what You combination hope Can efficacy rate you the to see arms you there's

David Roth

Sure. question. Thanks, that for Phil,

XXXX So gather as plus relatively we've very doublet low that XXXX in XX% the plus gemcitabine you just patients of the an aggregate stable disease with we've have shared with can already we which plus CR disease. PR disease eight four excited generated doses having with control, We've about mind that about up we're is you. demonstrated data at you, control of the rate which out

very particular, combination that's feel population early type of stage. we line for with therapies So this benchmarks because clearly pancreatic is in other at in with that exciting In this cancer.

below make I referring other went what the it reason have from was the we we an had the to increase because durable I with over as Now show would comment marker dramatic single doublet, response, in milligrams standard was more XXXXX that plus of a in phenomenon recessed clearly, a that's blood. confirmed the saw with of a demonstrated you the at our And four milligrams partial will able very XXXX who relationship, dosed that significant. we're a to to the the down us And mean even proportional the CAXX-X, gemcitabine similar get drug give in tumor where to emerging XXXX. of XXXX where we we of circulating emerging really are doses that, agent to the exposure in is, when levels drug drug data believe that increase patient more dose gives us response reduction exposure. exciting, with

haven't reason that, and maximum think to cancer. could meaningful hope impact any we for of the can which dose notion any patients us with the respect that, regimens gives even a yet, to the clinical be push we the pancreatic provide with seen Schedule activity we at with more the Seven-On/Seven-Off So, tolerated dose may better further, really

I in So question. But quite compelling. that we of answers find your the hope data sort aggregate

Philip Nadeau

on be the maybe no then, your us X discussions who That conversely would signs question And on your of ideal partner? the continue? does start trial help. would kind give you of Phase And then partnership, a can some mind, in that a on the one sense partnership while if own, you

Nancy Simonian

Okay.

be I at So opportunities going of looking a partnership XXXX. strategic mean to variety we're for

opportunity you've excited emerging, As opportunity. big we're activity response I seeing, of tolerability, that, very relationship. think in a exposure clinical the we combination heard, CDKX broad as selective really the about an from a tumors, of including in inhibition the David, range we're that And think

about about speak resources excited for we leading trial. further are focus beyond opportunity to our but the escalate, of this on the to in forward. value to sort we're plans to We while take safety portion in interest our moving So that's of the for the we've program think maximizing the targeted the the of to no hematology now, drugs dose best time, portfolio. partnering continue At point folks going right

Philip Nadeau

Was to remind I us according to the what safety about on or randomized had lead-in achieved? to SELECT-AML-X. moving forward discuss was there permit design, And the that the Can you more safety you the for specific the profile very to to want know then, data plans last question. That's portion? a hurdle don't helpful. be portion, the for

Nancy Simonian

schedule you a -- safety have the clinical But forward comfortable the the have mid-XX% similar general, we're to make activity and at the in moving in range. sort in obviously, as portion. of of well. and with And you're population rates kind randomized lead-in designed think, composite is that that looking dose to ASA the as a into of some patient Vene Tami also, low I sure doublets you know of CR ASA a

about to have of moving looking look we're So discussing we the the as into excited next than we at data initial also about that trial ASH. something clearly that it forward for the opportunity to higher we we're have phase the think and and

Philip Nadeau

very taking helpful. questions. That's Thanks for my

Operator

with will Oppenheimer. come of And Shu line Please from that go the Alexander ahead.

Unidentified Analyst

on a questions. Hi. few This of Alex I Mark, have behalf is calling Oppenheimer. at just

nine off was with XXXX plus past combinations CDKX triplet? what continuing nab-paclitaxel plus the so the testing behind logic the your First gemcitabine noticed the like we for with program, not or like with gem – six

David Roth

Thanks for that Sure. Alex question.

think single are general agent the arm very to to arms, to When nab And just to up data maximum across again in the the – five the agent, has to That's up And that about then can agent. we tolerated focus not maximum you seeing XX tolerated yet the doublet our contribution gem straightforward And do research dosing. of define activity demonstrated we're a I on because add really on of gemcitabine. where gem the two dosed to single very important the of you, Obviously, together triplet. development we've we're interpret milligrams single clearly up you to all to four XXXX drug critical very backbone I ceiling So doublet of we a the remind it's clearly want understand the excited the it's in the paclitaxel dose. and in in to dose. it priority. a for define that helps in

steps. garnered we to also said, That interest define it's with will outcomes that because next the on have interpret of to basis those doublet of doublet the So the feel the that the priority important for it's triplet. our help

the to interest be step future should the the moving focus at for going So forward. the They'll haven't just in two. said, triplet some we're the really those retain in point immediate but we enables triplet doublet the think move on And we program explicitly foundational to not whole next forward.

Unidentified Analyst

next My couple of no Thank that's fascinating. you. questions. No,

have I your So program. about question AML a

what of the due decision? mind four treatment that factors you add just elaborating physician contributing abstract the this to we decision. on kind So to responders we to one and of like discontinued Do noticed retroact

Nancy Simonian

Yes.

the looking of As at ASH and earlier, time. data details discuss at we we're presenting to data of said forward we'll that kind

Unidentified Analyst

Okay. No Thanks worries. team.

Nancy Simonian

Yes.

Operator

Thank over I'm turn remarks. now to Simonian like to time. call questions the Nancy this further no in the for you. closing showing at I queue would back any

Nancy Simonian

for and and continued out us operator support and for reach XXXX an today everyone soon. of with period to you your of you Have you, The a thank updating joining Syros. further exciting any be look remainder Thank questions. we again Please forward will great day.

Operator

This concludes today's participating. conference for call. Thank you

You may now disconnect.

Syros Pharmaceuticals (SYRS) 14 Nov 222022 Q3 Earnings call transcript