SYRS - Earnings call transcript Q2 2022 | Syros Pharmaceuticals, Inc.

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Operator

Good morning, and welcome to Syros Pharmaceuticals Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in listen-only mode. This call is being webcast live on the Investor Relations 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 Courtney Solberg, Manager of Corporate Communications and Investor Relations at Syros.

Courtney Solberg

you. Thank issued and announcing a we XXXX second press results financial broader a morning, our release quarter This business update. available at is of release in and Investors The Media Syros' website www.syros.com. the section prepared We'll begin by remarks the Dr. with call Simonian, Dr. Chief Officer, Nancy our Executive Officer, Chief Financial Jason Haas, David Officer. Medical our Roth, and our Chief

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

any our like the to we statements. I revise disclaim implied representing of our annual we could forward-looking should I or statements and only subsequent and of particular, highly Technologies to including forward-looking of strategic may statements and as Any be will those conference with our are pandemic call represent which predicted to including continues third materially section any differ forth other include forward-looking depend would Before not SEC begin, operations remind the relied a views make our any which on planned to on to by would everyone Nancy. on expressed as this that results specifically TYME be developments, update XX-Q statements we as morning call concurrent upon report from uncertain like risks, and any turn the now any the date. rely Form those We future. that report which call to with private forward-looking in statements of on over uncertainties to statements and In our as with this parties impact this other related Risk we and extent future the factors the COVID-XX placement. made cannot those various and to filings obligation make that we confidence. Actual or in views of today quarterly Factors on our merger on or will filed the Form events set result XX-K

Nancy Simonian

and Syros Thank strength. joining late-stage important building with a enters that In thank a company you morning, medicines care made the you, to of of half this of progress in with Courtney. patients of months, the past today. Syros into for towards we've have a new deliver small-molecule Good us everyone position cancer. the second potential standards year for portfolio

XX data pivotal in our our the study of promising SY-XXXX, are of Phase and and expected SELECT-AML-X which are the cancer. supports over progressing next confirmation to This the is initiate and pancreatic clinical the advancement toward XXXX to SY-XXXX readouts have Phase which X Our well months. data data we dose Today, the are includes trial of pleased of XXXX. report leading portion multiple from second data programs Phase track half preliminary we our trial from safety of from trial, in on X to X trial SELECT-MDS-X

a one cash data to Technologies half second our in investment our these to expect through our previously XXXX. SELECT-MDS-X $XXX we loan secure pivotal TYME Additionally, a along XXXX, from expected beyond of with extend July, will we into as approximately Oxford, trial. runway the year announced amendment Phase anticipate Together, ongoing X merger close least with we transactions the agreement the concurrent at which in of with and to expected announced million are both pipe

the call shareholders our will over progress recent I have forward the ahead. we strategic programs. months collaboration value We and We and our preclinical team process. to our will our are incredibly turn grateful now look to review TYME investors clinical their their throughout years and to and support across for made existing who in as as the for the new company maximizing well the to combined patients, David, for

David Roth

our Nancy. trioxide confirmation ATO. promising form We're XXXX, dose you, of oral pleased Thank to report novel or from our preliminary today arsenic of trial data ongoing

measurements to first or As and fasted the data XXXX support are The events for on ATO, No XXXX a administered XXXX of IV crossover XXXX data PK continues reminder, data study, respect, achieved of that study our the Cmax IV signals preliminary is study, Based sets toxicity a Safety states been when directly dose ATO. to X as of to to each in this severe a our no is has a profile. have IV new with administration. directly to with identified this Syros AUC dose favorable XX-milligram and And based at comparing in have QT X.XX prolongation, safety kilogram, well on received the in milligrams been single study, patients acute tolerability fed per were approved been which the this dose. exposures In cardiac ongoing ATO. liver reported in selection. in full goal approved taken this the with and and have IV the particular Phase promyelocytic dose study XXXX as to associated or comparable ATO. important with at and provides IV from dose Cmax that after the of compare AUC adverse ATO leukemia trial, APL PK

study of at identify approximately to advance assessment Additionally, first our XXXX of is with dose and patients XXXX care study expect which of Furthermore, preliminary to of into replace bioavailability of system. We're quantitative health across treated patients for the has context to this bioavailability XXXX the XX%, patients intra-patient XX crossover study. Phase the in planned optimal oral expected high oral to XXXX our milligrams, that care multiple to standard for the is showed the the incredibly PK ATO consistent identify can second provides potential data exposures enroll encouraged be will trial, XX which a is dose, that XXXX. by in of be those includes achieve we to the burdensome IV continuing continue able original Orsenix, from we for to milligrams both with conducted or and This APL, which Phase X of the confidence, in IV planned half trial. dose initiate confirmation further the X the that treatment those which

informs approval XXXX Additionally, together in from received registration on the plan decision the EMA for feedback feedback both pivotal from in with the can single move the US XXXX, Medicines trial July, we forward development of Agency or with FDA, European a to support which EU. the our prior and that

track RAR SELECT-MDS-I our treatment tamibarotene, agonist, to potential patients, with to and for diagnosed open the who and we RARA-positive and opened tamibarotene neurology set new in the additional pivotal trial early MDS in a expect unfit and data is have XXXX expect report sites or has globally alpha higher-risk late XXXX. The to We to potent months on Turning AML. newly XX sites, over paradigm currently selective ahead. overexpress

that implications term. our well we issued June, we estimate a over as EMA positive enrollment positive, data the opportunity MDS as XXX long Also has that RARA ongoing we from in and approximately on now patients, based announced which study, the believe for positive centralized Importantly incentives disclosed as of XX-year August, in both criteria, we patients of opinion in Medicines market XX% MDS. of assistance the a authorization. qualify EMA's product development on drug designation and access fees, reduced phase to and after designation market marketing regulatory the financial EMA orphan that during our from to orphan meet for including exclusivity, application approval for the tamibarotene, treatment protocol period the product for at are

the care tamibarotene, potential No and and existing provide and drug favorable in MDS therapies need advancements targeted and February has As represent in We novel treatment a in of patient lagged higher-risk a reminder, of strong convenient designation which effective, believe tolerable milestone demonstrated development. Hypomethylating by drug or agents be behind blood MDS approved efficacy tamibarotene to in been HMAs, the therapy remain a options. are orphan for HMAs who agencies year. MDS. first Despite limited tolerability outside an patients, of largely a has successful standard the broadly, These cancer MDS has has was of this more granted decade. have the in over mechanism in important FDA population for efficacy. decisions new in

you the a Phase we're in of one About AML. do unfit AML II diagnosed evaluating newly care with also and not of SELECT-AML As a-third the patients, tamibarotene and patients standard trial know, majority relapse. azacitidine to in unfit RARA-positive respond venetoclax

that the providing early and AML, study the for at triplet RARA lead-in look the to safety venetoclax an the data translational enrich to to respond response from time regimen to regimen more care in with rates biomarker patients half this as for the data The RARA-positive and We and evaluating will SELECT-AML-X efficacy well as safety of in and tamibarotene, second assessments provide of whom tamibarotene Our trial the clinical likely azacitidine on suboptimal. forward patients, safety, believe based an our data may is of be and look standard to the of triplet with of support the of objective understanding and activity portion potential clinical year. we response.

initiate XXXX from RARA additional to patients, in or Additionally, randomized in positive randomized the we portion XXXX. the data of XX expected approximately portion plan with the trial

forward about the determine also with I in combination Phase the cancer to being inhibitor we is intrinsic data, CDKX XXXX, on the portfolio, our with X-FU ongoing patients trial in the this of now track standard investigational chemotherapy of additional approximately safety Roche's patients. pancreatic I'll and combination the Phase lead-in The for later atezolizumab Based PD-LX by actively of in encouraged course an to XXXX with a momentum approved I/Ib XXXX. remains portion pancreatic potent BRAF Currently, the of patients. with data year. trial care will mutant ONIVYDE for the clinical three of we more to Finally, combination oral turn ongoing I cancer. our is potential selective the activity as is cancer best second-line survival progression-free months. arm in Phase We're look for colorectal these to coming months highly agent inhibitor. of XXXX our across only each and We're sharing further offers pleased in continued trial in clinical in development XXXX safety relapsed/refractory change of therapies evaluating on average enrolling from data, report very and that leucovorin, which evaluated learn

SY-XXXXX, and DNA instability, turn control caused leading demonstrated selected Preclinical AACR cell-cycle presented to CDKXX nominated and at July, next models. our that I'll in April engine. oral preclinical potent In in inhibition decreased selective as tumor candidate. genomic to and apoptosis repair growth discovery and development CDKXX data Next, gene we our dysregulation our inhibitor inhibition

with regression tumor combination small and of induced selective agent a leadership and inhibitor with demonstrated inhibitors. cancer. derived ovarian intimate of in small lurbinectedin cell olaparib nomination model to cancer, and model as activity selective lung well Additionally, model, our as lung in PARP inhibition CDKXX the gene a as testament patient single in breast resistant a This cell Syros' control xenograft is discovery CDK a in

As XXXXX, in and well we for also XX exploring July, WRM partnerships programs. CDK as for we're our announced as

each With We advance our capital to our robustly term. the call are financial potential assets, which this the confident focus on our we to programs the to patients near approach Jason deliver review results. I'll clinical the will to our greatest discovery as over benefit turn us have to allow that, in of

Jason Haas

David. Thank you,

XXXX entering in position. be to strong second the excited of half are a We financial

Technologies, July, approximately we $XX million. agreed its As in Nancy including with to net assets TYME, a and TYME definitive where mentioned announced cash merger agreement acquire have we of pipeline

shareholders Flagship, existing was agreed announced Healthcare We sciences pipe Adage, investors also and million new Bain, The Avidity, Track, in Cowen fund life Invus, Deep Bridge, and Ally company. investment pipe and also included as $XXX existing by invest and Syros Investments. our financing which a a to combined new focused Samsara, through led such

expect pipes approval shareholders of and customary at of We other the in year TYME close the this half Syros closing subject merger to the and second concurrently the conditions. with

senior milestones our the extend Oxford certain to interest-only way March subject amendment conditions, an will loan September XXXX upon Finance, and March XXXX facility to XXXX. announced with of period to certain to also from secured we July, the all in payment the Finally, which achievement

our commercial past and readout year a than more also trial is which XXXX, sufficient $XXX of Following our we the and million us data into capital cash from these a requirements SELECT-MDS-X transactions, the pivotal close expenses operations build support to expect launch allow be and have will planned capital this approximately to of balance out fund operating believe to expected to temperate. we of our our expenditure

to of I'll million Now, and GBT collaboration consisting our of in recognized with quarter from our from $XXX,XXX turn our revenues quarter the XXXX We $X.X second collaboration $X.X million in Incyte. financial results. with second

to $X.X with quarter second XXXX. recognized were to million in XX.X% XXXX, expenses million the GBT and primarily in due of programs the were continued was due preclinical G&A costs This compared under For and expenses. XXXX. of second $XX.X for of quarter total XXXX Incyte. quarter associated and second in of the revenue we the a R&D the million increase our primarily expenses This of our employee-related expenses. as million for collaborations $X.X to second quarter second XXXX was increase quarter to $X.X with compared clinical advancement the employee-related of

or compared million in to $X.XX in the to XXXX. will the second share a for over net questions. operator net $XX.X loss With for call period per of same now that, turn reported the the per loss or quarter of $XX.X Finally, a share million we I $X.XX

Operator

[Operator Cowen go question Nadeau Company. Instructions] ahead. comes The from & Phil first of Please

Phil Nadeau

on Congrats for progress morning. questions. couple A could. Good on the XXXX we of if and taking follow-ups our thanks

specifically First then is you relatively any I but patients? or any GI the tolerability profile mentioned toxicity? it there across such XXXX, second associated dosing And is intra-patient oral know exposures as to was in AEs the there variability with consistent good, are

David Roth

David. It's Bill. Thanks

And So, in reported our it's actually very can really been think we say an about is parameter a the help move had XXXX. that is events. select really to go-forward no I I good we that we to variability. to our need to-date events haven't data totality the generate reports that dose. I start specifically. adverse Variability to any of that's X of by going events we've But that on important to with set haven't order seeing and what that to respect adverse and going what we're we're encouraged real question of we're With in half dose adverse to confident we've forward Phase have the to trial serious a mentioned the had second -- inform

reason issues So, very moment have at encouraging. effects. form But for observe encouraging the ATL. things tolerability we are looking oral no us to more and profile seems to of the potential expect very future opportunity with side Obviously, there's any

Phil Nadeau

very the remains That's sell are of the you the light to far data you've what study? still good In be optimized that through parameters to helpful. for? of seen continuation thus What trying

David Roth

Yeah.

I so So X.XX is think at I think milligrams per that all the thing is we should IV appreciate that again, main dosed ATO of a dose kilogram.

interims of on gone form to dosing there's really it's influence we the based so with the the measuring this understand We've the dose. And the we're flat initiating understand So characteristics feel we whether patients. for of XX-milligram is on any weight-based in patients algorithm that those and trial exposures adjusted. characteristics exposures important a the

way. look to because has obvious dose Now is the their by IV an way normalize to one chosen it at the

rates that of good exposure. have whether to a influences that parameter sense as the is range enrolled on the depending a of we'll So patients,

feel So coming not see between good the us model the patient to insight into same we But trial going in relationship patients into we develop are of weight. determine can weight, the case. the obviously a dose to just exposure breadth that's going be are that the get with about not adequate who that. if if an need to we're and everyone Obviously, the helps getting of lot body comes to who

to out different right our just types in the of that's go to the appropriate be assure think treated. with model exposure range set main data robustness may the that who or looking the is at we're of I patients the thing now of So really build and

Phil Nadeau

makes Okay. sense. I see. of That lot a

Second SELECT-AML. question on

measures And earlier this mentioned of You will year we'll year. during at you've from in I get mentioned, think we the end clinical measures or response Are rates. to going be half activity? of activity response second the of SELECT-AML get remarks, it the rates the perhaps prepared

David Roth

Yeah.

safety, Obviously, is of triplet main thing where portion pro randomized lead-in trial treated the newly AML. our to looking a But we're of what at all being doublet the trial demonstrate. that's need you of actively diagnosed the the and benzene look testing benzene compare calling that a for we'll Tamibarotene that's So opening to right? So safety to [ph]. we're we these patients the that unfit are in

So we're thereafter. so on going aspects to times all being two, months three after the have are responses bone one, and done marrow and and usual

you'll right? that to primary activity endpoint it's rate. think reasonable And measures, is are in usual I addition So our the those the to all So expect see CR/CRI safety.

that be we'll response the who at the so forth. for so looking determining have obviously, and we'll to on looking patients and and speed So be

Phil Nadeau

Thanks questions Got on it. That for and taking is congrats very progress. helpful. the our again

David Roth

much. you Thank so

Nancy Simonian

Phil. Thanks,

Operator

Butler The Securities. next Jason go ahead. of JMP comes question Please from

Jason Butler

taking Hi. just just do plan And in additional well? to remind and Phase dose the on questions. study secondly, guess to profile confirming Phase more dose before can a A PK as the the us of you the couple the is you Thanks but could advance lower dose initiating the X you Thanks. explore for trial? need into XXXX. then I work potentially or X, the one to confirm after

David Roth

Yeah.

So haven't patients be specific to a may into is going dose the recommend treat still finalized weight that may That's establish would why X, we're with we're be or going It to a we we the dose. that the adjusted dose moving ongoing. trial to determination. it Phase

you to if of we're happen really obvious things trial And that relate about think be that the that the to terms going forward? to comments initiation need leaning start-up. any the in between other that's other are where other trial have done and going of now Nancy, activities obviously things I I the think And So right now.

Nancy Simonian

going was the finalizing the start there's dose add I manufacturing then are the And for of Phase all material the III protocol. that, Jason No, just Yes. selecting to obviously the course, to the to necessary now kind start the of on-track that on and of the to needed we're Phase II under those Phase all with -- things we're that right III. very feel working confident activities

Jason Butler

then the Great. pipeline just programs. earlier-stage And on

You advanced a us I but just of, or timelines to just the progress a Obviously, give discussions of are? earlier level is those how discussions. can't there looking how discussions are? sense Can you priority give partnership you into understand sense those said what here, you're active

Nancy Simonian

Yes.

all on our very very we de first discovery potent in control important inhibitor just bullish great gene remain the nomination terms selective what excited of So, candidate I'd it's these say I to targets. and novo a can that, testament of regulatory do of our scientists engine inhibitors CDKXX think is,

robustly As you programs of think kind we in interest know clinical that it's seek the develop those that as best to now late-stage have early capital we we're our to of that on adequate these focusing programs. pipeline, we partnerships ensure

So, discovery of we'll apprised we have or the oncology more partnerships. keep we into programs that. to on discussions of But feel ongoing being one confident and you going on, terms able in enter

Jason Butler

question. Okay. the Great. taking for Thanks

Operator

Mark The of [Operator Please Oppenheimer. next question Breidenbach comes Instructions] from go ahead.

Mark Breidenbach

Good morning, thanks question. my guys and taking for

quick Just a me. few ones for

to of in Thanks we of for plans later indications can randomized of collaboration? quickly, mean Pfizer the what's the what the final to safety of you SY-XX, XX. on your feedback of is, for trial And the Pfizer as GBT that with soon cause the SELECT-AML-X lead-in and the terms that change study? to design question pivotal your very developing hemoglobin question. your does does acquisition Is kind timing initiation like feedback year, any or would that by substantially Another kick-off something First that for fetal influence looking you points? size EMA inducers? end portion the regard to for we pending continue getting for see taking one me. Are as this expect one data? want the Did

David Roth

Sure.

Okay.

was related feedback on EMA XXXX. first the question So, to the

benchmarks we dialogue feedback and in corroborating that. solid proposed our can move upon with Administration to had important and the which giving and Food endpoints and So, really Drug we was foundation on assess us with those forward very our various endpoints a received fruitful strategy. already like it And approach things from a

So, the structure we that and size. approach that strategy had strategy a vetted to to received We general study and take that good also design EMA was there for alignment solid. took terms of we for in our

come approvals to notion one with from the we an US that in so Europe. now seek we opportunity And boldened back global meeting protocol have to that and use both an the

for very So that's exciting plan. really feedback and our positive very strong go-forward

to this randomized the plan the AML year. the year, later obviously, forward coming And target is portion. this of in half current data trial, on obviously, second our With safety of the out lead we're to move with report

And the to As that, specific an portion I'll on give then let opening we'll to GBT, one was the we you the and update that take the of closer related get Nancy last randomized timing one. of trial.

Nancy Simonian

the ways neglected our that thinking we overall a that with acquisition. which about are of, which sickle potential we and GBT, with treat, sickle we cure so which sort exciting kind it with disease cell of collaboration so really excited Pfizer and we're it's obviously, disease to patients really the for for ongoing very GBT in have field And inducers remain -- of, Well, I all fetal that me been long about about medicine. to oral functional disease that hemoglobin the great news there's to incredibly the give we excited think for has can to molecule think small real acquisition. an And is pending interest opportunity a suggests I to yesterday improve develop, think cell a is

disease have actually we'll for right think we it In cell as where sickle we're better overall what more relationship. positive but our doing terms that's a it's discussions learn we it as going really news with to relates now from about doesn't the a our idea collaboration, of impact GDT, but community. But

Mark Breidenbach

All right. Thanks again. so much congrats and

Operator

to closing I remarks. to questions, Nancy are the conference Simonian there like that back further over would no Seeing for turn

Nancy Simonian

and out support you everyone company. today, for have as We build leading you your to a into Thank you. reach again if forward Syros you to our continued soon we thank Syros. Please joining look and of operator and us further updating any questions. advance portfolio for work you, Thank biopharmaceutical

Operator

The you conference presentation. for attending Thank concluded. has today's now

now disconnect. may You

Syros Pharmaceuticals (SYRS) 9 Aug 222022 Q2 Earnings call transcript