SYRS - Earnings call transcript Q4 2021 | Syros Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning and welcome to Syros Pharmaceuticals Fourth Quarter and Full Year 2021 Financial Results Conference Call. At this time all participants are in listen-only mode. This call is being webcast live on the Investors & Media section of Syros’ website at www.syros.com. Please be advised that today's conference 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 XXXX with anticipated financial and accomplishments. we and fourth future press recent year full results, a morning, our release quarter milestones This along with of on & This the is at www.syros.com. available Media release section Syros' website Investors

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

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

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

Nancy Simonian

with recent thank and year today Syros, at you fourth a full everyone review our of morning tamibarotene and expansion in X and SY-XXXX risk Good Phase Courtney. RARA-positive XXXX quarter towards driven to The dose expertise, and patients. us pivotal These for you patients. study Thank updates. joining a in combination fully with becoming with A profound was in results a patients finally the SY-XXXX RARA-positive advancement and financial and AML. by with for higher integrated commitment, the our we portfolios, year across initiations to hematology inhibitor first clinical cohort, Syros. biopharmaceutical pipeline patients, SELECT-MDS-X in of including Last pancreatic with tamibarotene for SELECT-AML-X and our cohort trials our X cancer our the of one study study patients and three CDK targeted an expansion highlight difference pivotal trial, capabilities chemotherapy confirmation initiated potential company team a year, Phase make of MDS. diversified of APL

data BRAF-mutant are Syros advanced evaluate and escalation inhibitor. reported September, in preclinical well and Additionally, the oral results, the rationale as to well pancreatic opportunities; we XXXX, Based clinical dose exciting malignancies. selective phase our three we CFO as data, appointed forward to with highly success. And Jason as hematologic Haas on anticipated readouts in looking October now potent Conley next commercial up new support as Commercial work as to two been continued for cancer, laying from an colorectal planning of year Chief and Syros spearheading distinct our our of X progress trial three the XXXX, Phase CDKX mechanistic data a we XXXX has September, To our named cancer in promising as Officer our team hard appointed efforts. us clinical is key Chee our growth members. set across the who financing at been has in first we groundwork portfolio. In leadership to

phase safety will to we in two trial tamibarotene SELECT-AML-X cohort report into APL XXXX data development of unlock expansion each confirmation from may the these cancer. the of clinical And dose leading moving second pancreatic activity our midyear. XXXX the plan programs be important Then safety inform this trial of and of our data and half strategy from insights potential sharing of the results portions we of forward. PK year, First, our in in of the

meeting engine, as agents. and and e-poster has term our as our cancer the small we an in decision next would second goal potent and of molecules presenting inhibitor DNA the programs I This review over April gene multiple selected to in forward David discovery which David? like as turn activity, oncology our development our gene to year. preclinical program, systems. other half program will in looking a of expect long single well in are CDKXX driver to AACR who our on-going key target WRN to to vivo our this vitro reflect shows that our nominate our regulatory support in control at the discover that tumor programs. as we productivity of call selective and develop to CDKXX highly in anti Additionally, now clinical the CDKXX, potent, oral from effect models, combination damaging with do enhanced well These data candidate agent

David Roth

Thank clinical will we’re you, I pipeline our readouts stage important and review the year. this discuss Today, Nancy. anticipating upcoming

for look patients trial pivotal or regulatory option. higher us forward NDA to successful, filing and will diagnosed up XXXX and We and expect XXXX these XXXX. well-tolerated our is in next to rich If for data RARA-positive I'm report milestones lot has either to as have MDS with late progressing two to newly clinical risk the to in the set early the the risk years. well, excited catalysts SELECT-MDS-X have trial a potential effective tamibarotene patients higher we potential treatment MDS is a offer that

is therapeutics approximately the diagnosed for the U.S. XX,XXX new in approved unmet decade. and no mechanism been this action, approximately could high indication MDS have promising risk higher medical drug for of of clinical a We over newly MDS who standard-of-care Tamibarotene, tolerability there XX% agents, patients higher these hypomethylating for from a EU in the Aside annually. risk and need with are estimated activity, a change patients believe RARA-positive. an favorable novel profile oral The

providing is In of market that a addition development to the received progress are benefits, we seven in we in the drug we from for year MDS important are February, period milestone representing making, approved. exclusivity drug the including designation an pleased the orphan if and of certain tamibarotene FDA,

for companion diagnostic to their AML often approval, cancers. physicians optimal determine test. turned for targeted will following our agreement the RARA-positive Since benefit who responsible agreement, and in to tests readily March patients MDS higher using the a a the we QIAGEN of integrate as diagnostic the risk MDS. to maintaining launch, the to are QIAGEN RARA ahead therapy approvals commercial for regulatory master and We may diagnostic for treat test commercialize entered anticipate hematology targeted they to RARA and develop higher that blood Under will MDS look testing for risk both using RARA-positive standard-of-care companion we As Tamibarotene. potential routine MDS, the treatment collaboration subsequently our companion potential and proprietary be into for also physicians diagnostic identify a with biomarker familiar with obtaining evaluation terms patients commercial of from

Turning to efforts our AML. in

in year, and there in each patients is populations for and patients evaluating data patients U.S. to substantial with newly and as EU potential Tamibarotene, AML. We whom to Phase more that the unfit targeted AML. and for tamibarotene diagnosed the We about the are RARA Our representing on-going for SELECT-AML-X standard-of-care there's a study tamibarotene of AML ven/aza in likely X clinical approximately to enrich XX,XXX market suboptimal. combination be diagnosed the for XX% opportunity with in of RARA-positive, newly RARA-positive one largest the may our believe unfit in estimate AML biomarker are translational unfit respond support which

from of second in safety leading year. Nancy mentioned clinical SELECT-AML-X we're this data on report the track As the previously, cohort trial activity of half the to

the approximately diagnosed which regimen tamibarotene a endpoint alone, unfit response composite the will evaluate newly XX to primary the to be is will AML RARA-positive this of plus patients. As our then into triplet ven/aza cohort complete successful, If of portion and trial, reminder, compared enroll ven/aza rate. we randomized advance a will expected

as well to reducing The and on-going patient trioxide by effect APL. trial. to In the Type the replace path of the evaluate XXXX addition, received of goal ATO we from We the we're dose for clearer upon dose patients. could and costs optimal from ATO also the arsenic burden, we promyelocytic limiting with developing of the in or mid-year. to increasing acute designed health utilization. XXXX development dose tolerability confirmation access From believe leukaemia, significantly confirmation identifying the care the feedback X ATO, APL. the trial form IV Cmax or APL a for C frontline as food an of XXXX XXXX in for for data as novel a potential FDA have standard-of-care oral report is treatment is AUC with using Phase November, meeting the IV plan has We and which form XXXX pharmacokinetics trial improve and

In the survival each at the years event response for rate molecular historic ATO. primary approval primary XXXX with in the to free data as its patients support complete meeting, for case, the this for two accelerated clinical full generated Importantly, compared treated rate endpoint be endpoint will agency as with approval. reaffirmed using and IV data at

outcomes the patients with us initiate arm. assist with the the two tolerability safety to X expect Pivotal IV in expected enroll in or XXX We to and X one approximately XXXX. overall randomized arm comparisons study Phase plan study in XXXX of quarter IV receive Phase data XXXX to of ATO, to in We the to make ATO year, the the first next to assessing allowing

Now turning a low for AEs. X achieved We a and discontinuation predominantly In September, with data Phase we XXXX potent select to rate generally tumors. which dose grade selective schedule tolerated highly with proof-of-mechanism inhibitor. promising and of low dose AEs announced to and oral study identified due solid well CDKX our escalation treatment patients in was our from and XXXX,

tumor pancreatic single population, as preclinical in the on well patients In marker relapsed Importantly, this we as supportive fourth cancer for patients pancreatic saw the clinical refractory well the combination tumor enrolled. disease, initiated reductions. we refractory expansion quarter highest cancer. as activity level cohort evaluating in with data regressions Based stable our of these vivo agent data, with refractory XXXX we relapsed observed highly in in we as chemotherapy patient XXXX

day year. responsible with XXXX trial, X/Xb their line Roche PDLX which will off with FOLFIRINOX biologically Roche updates. and a with We're seven of investigation in the active We second with of clinical with cancer. approximately supplying Roche their immunotherapy. Roche a dose an who clinical the of first from treated communicating we this inhibitor enrolling arm or first this In be enroll using also agreement treatment expect XXXX the first year, the have relapse. XXXX MTD is with regimen, begin sponsoring first a XX colorectal be patients Starting the of August to gemcitabine to seven safety leading data Phase inhibitor, progressed strategy with an of portion are second of in the on-going CDKX to atezolizumab. below will cohort half BRAF-mutant will to approved in gemcitabine XXXX XXXX with the combination in pursuing combination patients evaluate day INTRINSIC this following agents. the combination expects subsequent entered nab-Paclitaxel, we We patients combination or on data the trial and the in Since of XXXX report with in of combination XXXX for in half second the doses in trial plan activity mark

we vivo as In we population, a and malignancies, high of in and a a relapsed activity malignancies plan of cancers, which mechanistic initiate XXXX cell pursue clinical support CDKX hematologic and identify plan and demonstrated across XXXX data, inhibition on dose preclinical level the robust January, Finally, activity. single a activity. to this range XXXX preclinical in of rationale assess showed lines including in blood to studies, refractory tolerated trial of we CDKX to diverse based inhibitors, potential hematologic agent announced and maximum across for hematologic

strategy, and and addition, vitro. data confidence our forward second In inhibitor These X to trial give BTK with a seen in venetoclax half in synergy development look the we've of Phase a us this in clinical year. with we initiating

programs data the and are valuable by We and our clinical review to Jason dosing. year call over across incredibly this to to three results. financial looking that, provide insights reporting With clinical quarter safety, tolerability forward of progress activity, I'll and fourth our turn year to into with encouraged from full potential recent portfolio our all are the

Jason Haas

David. you, Thank

and have expenses first of with and We $XXX planned our now ended believe of the million $XXX.X XXXX. the full GBT quarter financial operating we cash, capital compared sufficient XXXX. with equivalents Turning collaboration cash in fund million into needs We XXXX million to on our fourth XXXX at with recognized securities our XXXX to plans, Based fourth quarter in of from $X.X revenue quarter and Incyte. our end in current capital and the year results. we marketable

$XX.X XXXX, year full the For we recognized in revenue. million

were million quarter and year year our year XXXX. programs, fourth for year million million compared full the continued expenses to million collaborations our the XXXX, recognize the million For for preclinical related XXXX. advancement $XX and $XX $X.X quarter R&D XXXX G&A The employee ended in a we GBT full in $X.X and increase under the of XXXX, with of and full $XX primarily the and of expenses. fourth December due as the the associated $XXX XXXX $XX.X expenses respectively. for XXXX were fourth total of full and million the to XX, costs XXXX, the quarter the million $XX.X year of in was for for clinical and Incyte quarter fourth million increase and

$XX.X for million For XXXX, full the the and quarter were expenses $X.X million for year. our fourth G&A

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

that, per questions. full net XXXX loss year to per $XX.X million, $X.XX turn of year full the XXXX. a share for million, $X.XX or the $XX loss for net to the call I'll With Our share, the was for or over compared operator

Operator

line first with of comes question the Piper from Our Instructions] [Operator Ted Sandler. Tenthoff

Ted Tenthoff

thank hopefully my progress really that's recognized. of we're question data this is markets very necessarily think much for currently know, for a in. of and is year I And thresholds Great, a should you steps, and be be a going being My data the taking do question what mentioned. that what worth determine first are that has get lot and don't and without I you that Fisher might lot But you. for tamibarotene SELECT and we for I the expect of looking Thank to of the to [ph]. sense with next to just from sort kind

Nancy Simonian

hear Hey, David. that Ted, I'm great you. going to to turn from over to

David Roth

Thanks question for Ted. the

for, important to and that with be forward. the clinical response looking we’re which in Venetoclax the we things we'll combine patient be are the is referring move assure looking reporting them safety can population X, benchmarks And of have activity. plus drugs clinical tamibarotene compositive safety we looking and use XX% to lead And of tamibarotene we well, sharing of study, from approximate our the will data, forward same parameter all one SELECT-AML-X be the safety to particular, AML an the at to plus well a where rate. in Phase saw complete we'll came in we three But and what obviously, in as So the process the for aza an activity, as combination, azacitidine. trial as triplet respect we're to

a that, Venetoclax for justify be So the starting certainly That into looking that adding we'll north are, be responses regimen. of place. would to

Ted Tenthoff

response of don't that? there rates question exactly that's the you is sort opportunity as ven/aza guess and are opportunity looking the I I And think compares go. patients also how to seeing I at positive to want and current that for where are you of have sort because where is, Well, you well guess respond an

David Roth

Yes, clearly really drug. population The ultimately of well do have It's we response. in tolerated patients who a I an this don't therapy. with population benefited majority improvements response well, think available multiple regimen not great their tamibarotene think the We achieve generally on we patients lose for the and needs significantly opportunity about administered an has Venetoclax orally third really of reasons. know initial who

regimen So, these will to deliver we are patients. hopeful that value our

Now to patients show we study meeting, very to we [Indiscernible] ASH entered additional the prior data the majority unmet yet who had who or to the where are for were that translational these refractoriness therapy Venetoclax, at had that to that excited this, of be consistent with refractoriness shared this things associated holds the positive features to need. are known address potential our

investigators the great about up. who see so and are are enthusiasm the very We signing And we're from program. excited who the patients participating,

So, this We're get share going half of second how very is information to to upcoming about the going be into you'll look performing. year is exciting insights and that, year.

Ted Tenthoff

on helpful. get, to any is And last much largely in Or just already it or if X then Thank the sizing you question, help Will very That's with X? terms comes really that will this questions. powering help that of one may, Phase that I response? of set? the pretty the When much data you all the for Phase topic.

David Roth

you're the talking if ammo… X in about So Phase

Ted Tenthoff

Yes, yes…

David Roth

haven't we seen…. So

Ted Tenthoff

help this you year, SELECT Will it? Phase you. size AML? …that design Thank the X or later will it

David Roth

the X. available to spoken This about this will haven't next presenting And is the we beyond plan specifically data yet randomized us the we year. So of this study. be Phase end a toward that's

Phase it not, going to told, information inform interesting that it's is for about. to think to the all So right specific whether learn I now, me future be or X forecast should but a bit information early design

Ted Tenthoff

guys Great, thank you for time. the

Nancy Simonian

Ted. you, Thank

Operator

& Company. Cowen from next Our comes with question Nadeau Phil

Phil Nadeau

One the to thanks SELECT trial. morning, as for Good Ted's questions taking on AML up well. follow our

you're worried could event you're at there that already to? that adverse look team going overlapping adverse exacerbate have? pay than that particular Are that me specific toxicities potentially the their to are there any profile, ven/aza events could be you As attention to

Nancy Simonian

to it your going over for I'm to thanks turn question. Phil David.

David Roth

Yes.

So tamibarotene by we profile and I of not Venetoclax. or increased myelosuppression, exaggeration are the We've specifically, associated have cytopenias -- not the have with of that very commonly been of seen noted any that, previously azacitidine and have safety general aza. described that and toxicities we use

any And ven/aza we we that, when there'll that. really toxicities anticipate so regimen the, be from that add tamibarotene don't exaggerated

we don't, be Of we course, to clinical expect case. that's our of part really that But experiment. don't the

Phil Nadeau

Great, on And XXXX. second, that's helpful. then

the as well finding you're including those of that effect. study kind food specific characteristics PK AUC order of as to there parameters. that of dose XXXX Cmax a mentioned pharmacokinetics You see, no going need advance for and the in this data, to there's hurdles simply correct or is Are where specific to you any

need know to You forward? to simply move what dose

David Roth

a so question that's now. Yes, good

Just drug exposures. we already the characterized that to with have already good into insight that important fact the this we and we we context, in study provide dose have X Phase a was [Indiscernible] acquired there you believe the the

So are is that arsenic technical drug doing China most right the we in success a single substance, important an trioxide, go methodology the had in consistent. that same blood to is Phase comparison Phase can be assure will forward of been direct will this do assured work. right what we're now, oral else the that taking measures into clinical shows in to the dose there's arsenic should proof-of-concept dataset, the dose. generated And with already of this used Everything X IV, The is -- we're X. to here way dose right with confirm to contemporaneously thing the that a forward we testing that

this piece a high just so being last is confidence for The dose confidence equation that will is right program. of have the to the selected. have we be And that us successful

And largely when by respect so I'll And information point is, we acquire want decided cured and forward population is reviewed but the we solid this the this patient drug, make to this footing. available we're, to we go is prove last ourselves, just we therapy. that currently the to on

this doing is good with of experience burden we all as on our we we to trial. program and about proof safety all collective welfare So feel of us sure go their approach. things our But And, really, I the into into to we're and this this right think protect assure make will the succeed.

Phil Nadeau

curve you're I'm to guess be must comparing IV, When the I'd an if different. shape of PK the wrong. oral me Correct an

equivalence? two sense So Cmax administration? Can it the Is what the you parameter different of, compatibility at curve, us very of is under is routes the area some an you key you're when to give matter? determine of showing how looking

David Roth

about blood. infusion. metabolism is administered largely correct an mean, Cmax at of over area end actually the reflects influenced and immediately the under And, curve intravenously occurs the I the you're from drug, Yes, which that. the removal by clearly the exposure time, the

more be And So be vary will the slowly. specifics to oral is exposure going the of those a with parameters may overtime critical. but which absorbed bit

are And our keep so in of daily pick patients induction, going IV both characterized Cmax to months be the over treated judgment this and best represents for drug of exposure. drug in a mind They're the months, using two AUC, other the consolidation comparable XX for these every months eight and prolonged we're month. nearly and periods that dose And daily for given a time.

And over going so, make exposure difference. a the intuitive that sort clinical to time makes sense is it of overall

Phil Nadeau

from question last on XXXX. then And Great. us

the are that focused malignancy out on cell more specifically you there. still let lymphoma, as broader Or investigate? the let the that's you In which malignancies, been perhaps data one for called thinking? with and to target has down XXXX. mentioned the hematologic hematologic population exactly know your You past one narrow populations amenable just you you particularly being of now malignancy hematologic are treatment mantle the Is group you

David Roth

pancreatic mantle tumors many ESMO at you which we that highest in the really cancer, saw solid data pancreatic advanced exciting I'll still rates cell remind the in saying we is me a of response lymphoma ways. in priority cancer. and let So where start in by shared

cycle of where of mantle in and we occurs. CDKX very larger lymphoma. rates the important know And response who RB in pathway high mechanism very abnormalities. has cyclin dysregulation inhibitor plays action cell cell important into that saw places also the And D in role patients that We is had

That So opportunity malignancies, mechanistic to a we also broader vulnerabilities we range a said, just mantle much breadth connection generated we the other that cell. than specific evaluated see cell. as see that we've a of of hematologic mantle very and suggests data sensitivities strong across

So as on in types, we CDKX we including a by dug cancers, foray would the go. that the be of explore served initial of, this heme data first we well then inhibitor, tumor way, the let where in to variety we thought first a mantle cell, and determine

So we the done capitalize to we're on we've generating, a information program. is and what this broad we've taking been really nice all initiate approach

Phil Nadeau

very Perfect. my is questions. Thanks taking helpful. That for

David Roth

welcome. You're

Operator

Our JMP comes Jason next at Butler question from Securities.

Unidentified Analyst

[ph] Fred for Jason. our questions. it’s Hi, taking Thanks for

a about that but ball response a crystal and for the times wondering read. quick about like median I It here in Apologies newly efficacy the month the half. in was diagnosed study ATL couple ones seems complete guess. yes, for for month we're a an the pivotal XXXX Just earlier a potential

and Just maybe a might look had one out be there wondering XXXX on if potential molecular CR for to CDKXX. quick read earlier at prior then the

Nancy Simonian

question. Thanks Phase to the X, FDA to I'm the based on in feedback. address maybe ask for your going timing David

David Roth

trioxide. the data in so November, on to their, agency historical for this which in are the we relies had had pathway, keep And Yes, they did with IV, arsenic this, under RB set they productive interest their meet a developing meeting. pre-existing we compared reaffirmed the the And in benchmarks. seeing very mind,

end benchmark So molecular cycle. CR, was at for consolidation the the third it of the assessed approval

event for two years accelerated the at would could be CR. serve So timing full for probably they've that we the would potential molecular our approval CR as molecular that said a And utilize survival that for the with free approval. also

So they of be all endpoints proceed. to we to got guidance would be versus the the they really with respect assessed benchmarks how would measured, think determine how to and we when we the need

the guidance clear any drug make very It crystal we're you from really decision. to excited forward. help in have So when development them having clear better regulatory doesn't about agencies a a path regulatory get

Unidentified Analyst

a CDKXX. great. much. on Okay, quick just very Thank you And one

data second plan the candidate that's half. clinical the gating the to the candidate? And So using you guess ACR going to that remains I announce Thanks. is be clinical what same declare just in at to

Nancy Simonian

to going have question. that I’m address Hey, Eric

Eric Olson

think the we'll we molecule I for of say data we're it's AACR. at one safe profile question. be our likely Thanks Yes. be Yes, a that we AACR at the CKXX that name on And our show the that to of second to the the development going presenting year to in is highlighting to candidate be program. and similar half

Unidentified Analyst

Okay, thank you.

Operator

with Our comes International. Jallah Zegbeh Roth next from question

Zegbeh Jallah

Morning, thanks for taking my question.

ask just regarding I a I think wanted one to quick XXXX.

You're already cancer. in pancreatic

do So just wondering already in then tumors? versus expect data. how escalate liquid to quickly solid can team use you some you've tumor same since as the malignancies that the And seen of you dose perhaps of that kind the dose in

Nancy Simonian

that answer David I’ll like He's question. – have

David Roth

Zegbeh. Thanks

dose a knowledge cancers. with advanced tumor in And to So the heme we've malignancies. about are going to the we we solid lot as move forward that in XXXX in how learned patients leverage

we'll will combining be dose safety that, with those the with be So we'll tolerated be maximum optimized initiating the our plan to gemcitabine or standard-of-care in plus the in the nab-paclitaxel combination and for then the program for, around regimen the partners. for MTD, levels that just using we've move heme gemcitabine and approved the forward

that'll I think think So move an is this design. And efficient quite that going swiftly. be to we

Nancy Simonian

know Zegbeh, you the heme also study? for to about the I think want how dosing we using were indeed,

Zegbeh Jallah

Thank Exactly. you.

Nancy Simonian

heme in study. we're The Yes. the starting dosing,

David Roth

you Yes. I Oh, forgive misheard me. have I'm must sorry.

we'll biologically haven't heme be guidance the area of study, we're to, heme specifics also starting So of But provided dose. we study, regards on at in to detailed the the going the really that around the with trial design. active

have the tickle effects with PD a actually know the where for our over So biomarker drug POLRXA time. the we and we we pathway really incorporated can nice

that knowledge well. be to leveraging as we're So going

if so And what at question around. we're quite that's time the starting you're I sorry, beginning didn't asking. your I'm first not the answer correctly

Zegbeh Jallah

look out will dose. there's No And that if CDKX, bit not perhaps your know, forward the at at be David. needing the And with I to trying for and guess just the looking that could to last to figure last are you if to to anything then figure CDKXX the just right or trying program, is you curiosity combined wanted to safe also you've whether then helpful. last, it here malignancies the pre-clinically is out heme the ACR. doses, worries very more your we're that about data could suggest be seen

Nancy Simonian

have David the answer question. I'll and second first Zegbeh, the Hey Eric

David Roth

heme I and malignancies so the with doses, tumors, again, to be the going to active MTD to of biologically just was like as out of in mentioning, we starting Hi terms dose. going and solid more close are clearly the we're and

prepared to in that achieve effects are therapeutic while modulate maintaining to We maximum dose safety. patients these

that's some there going be So to is on. exploration going

we stage expect dose can commonly of agent But is patients as so complex combinations, define that right heme And move we then in or and setting single clearly either in don't trial clinical to drug pretty with experiment. malignancies. be done. that utilization So the in a as the the we're obviously to a context, forward

for study, ourselves our future guess, collecting and up for appropriately I it set the Eric? we're CDKXX data analyzing So to success. Then

Eric Olson

is regulating been CDKXX that on role there. our in question really response. plays the of our Yes, the thanks focus really around damage for for based combinations Certainly, CDKXX the have DNA thinking

DNA involved agents, tumors in So, dependency we're work, such a of DNA impact a [ph] our PARP BRAF CDKX genetically or a other that defined hasn't tumors inhibitors. like as in that's repair, that repair where damaging combination about whether or other not in agents directly agents is there's been with DNA damage where thinking pathways our other primary like damaging kind CDKXX combination cells so on that's susceptibility agents, focus. really inhibitor But DNA

So combination. focus that's our been in really the

Zegbeh Jallah

Eric. Thanks,

Nancy Simonian

Thanks Zegbeh.

Operator

Alliance question [Operator comes Matthew next Global Cross with Our from Instructions] Partners.

Matthew Cross

in and from you Hi all, curious questions with good was taking terms QIAGEN a called start of of morning, first, looking because AML. the also on lot around that quick thanks arrangement had patients companion at a the couple Wanted you're in obviously, being in of congrats given for positive out off MDS around particular, confirmatory that diagnostic, me. to

want APL, separate of curious, something within the you're good those if if really even of then pursuing there, going of the can for confirmatory data with or or the curious X. commercialization own of it's was you But you results you of of kind Phase the into great partnership discuss XXXX. need just of necessary, sure need rationale your was And of be was you're quarter’s curious So that the a couple agency kind you that's do X timing I for dose as confirmation gap or making the sake, in the but strategy the confident just to the said, on with couple secondly, Just of make moving confirmatory and Phase agency team. in there? that kind X? limiting steps the talk review sure to Thanks. that quarters kind the and give those study curious gap coverage David That between Does confirmatory indication to kind timelines. the explain understand before initial the into the development data for expanded was Phase if that we of

Nancy Simonian

to I'm Matt. QIAGEN. the going Kristin? Kristin Stephens Thanks, question on take first the have

Kristin Stephens

for the thanks question. Yes,

trial that FDA, on And we input the use CDRH centralized for under the IDE X operated developed requirements. clinical that study. of using So a was AML assay division from our and original had was assay been have Phase

all tamibarotene, foundation development is and used for a assay our commercial serves this as the of the so it that's CDX. same the And studies been across of with

can So our beyond while imagine further QIAGEN, we haven't will provided agreement lead. that where detail with you

Matthew Cross

Very appreciate okay. helpful, Great, it.

Nancy Simonian

to. want David And you then on XXXX,

David Roth

requires transpiring. getting the that activating But, time that, over we've the reporting effort, specifically think details that X that we current data X. didn't explained haven't from the And the plan. midyear. initiating we're our I PK XXXX. between be think some guided trial what to global the Phase was Phase and It we're there to on-going safety of This, -- is the of on in quarter to challenge trial. any, first period any and particular, I initiating going So collecting the that and done That's we're data

Nancy Simonian

the that then a swiftly that Phase just things Yes, to need the we that moving to initiate we say can, the necessary dose, three includes as large X, there's these material, global study. which we're things all as obviously multiple activate and

ready go. we'll can this to the that I the things where related sort in best of nice is And mean, think all we to So those having really, work timing we is where thing know we from for because And of get ready exactly gotten those do. actually feedback the things, all kind to know we've now to need agency. that advance the we we the trial that

that's quickly to a we when this way great very So us going initiate to give launch it.

Matthew Cross

Understood.

just on to pretty clear of an data, you anything confirm wanted confirmation said the sounds internal moving that plan need the and guess, pivotal and that the that way again, that we long just wouldn't time. into it's I more didn't mean with really to was dose. by I any like of that to it run just study, that that Now based a FDA imply in they're

Nancy Simonian

Yes.

Matthew Cross

guys. Yes, for that Okay. Thanks it. Appreciate covers the it, answers. all

Operator

Simonian today's remarks. the I'd to turn question-and-answer like session. for That back to Nancy closing call concludes

Nancy Simonian

support you, on providing reach appreciate integrated us for everyone We becoming and your you a have look us Thank and wonderful to progress additional to thank if continue and further continued we to fully have a Please to out company. as you operator joining questions updates our biopharmaceutical advance any today. day. forward

Operator

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

You disconnect. may now

Courtney Solberg	Manager, Corporate Communications and Investor Relations
Nancy Simonian	Chief Executive Officer
Jason Haas	Chief Financial Officer
David Roth	Chief Medical Officer
Kristin Stephens	Chief Development Office
Eric Olson	Chief Scientific Officer
Conley Chee	Chief Commercial Officer
Ted Tenthoff	Piper Sandler
Phil Nadeau	Cowen & Company
Zegbeh Jallah	Roth International
Matthew Cross	Alliance Global Partners

Syros Pharmaceuticals (SYRS) 15 Mar 222021 Q4 Earnings call transcript