Constellation Pharmaceuticals (CNST) 10 Mar 202019 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to the Constellation Pharmaceuticals Fourth Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions]

I would now like to hand the conference to your speaker today, Ron Aldridge, Senior Director of Investor Relations at Constellation. sir. ahead, go Please

Jigar Good discuss and results Constellation's in afternoon performance. Joel. Reeve, and conference CFO. our and to call Participating are this call to fourth our Constellation's afternoon you, CEO; welcome Emma everyone this operational Raythatha, Thank quarter financial

turn X. Please to Slide

factors, our to results are those we certain subject including Before that risks I various may include will and to want today begin, Actual differ to due materially forward-looking important out uncertainties. in point presentation statements, described which the Form section as be well of of This and Report Risk tab our Factors as can most XX-K Exchange at Annual the recent found document Securities Investors website, on at SEC the filed website. with Constellation's Commission.

only call of views update obligation upon the statements these any as relied be no represent and not representing time. as this our as views to statements. subsequent of our time of undertake should We Forward-looking

turn the now, And Jigar. over I'll call to

and our This tell you afternoon Ron we of to progress are we XXXX. the Thank everyone. the for and excited first in about achieve making is quarterly call, expect what I’m about you, remainder good programs, earnings and to our

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highlights to First, with I'd about provide Constellation. some like key you

owned We and BET family CPI-XXXX, which CPI-XXXX of clinical have of and of a which portfolio wholly EZHX. target proteins, featuring programs targets the CPI-XXXX, both

also to to as as the able in potential monotherapy. first-line standard we've either line effects of And the disease patients therapy has a transform CPI-XXXX believe We or signals been second of modifying a in myelofibrosis. combo see potential care

cancer. prostate in CPI-XXXX developing been we've addition, In

this determine X ProSTAR next our We are steps and study Phase now plan fully in to year. later enrolled

engage of at EZHX our which been in EZHX molecule Of a has from source the to different for note, will We opportunity of Constellation. expands the own our innovation inhibitor, CPI-XXXX, way. were inhibition. discovery second-generation programs developed continue designed to this be on believe target all our Moving potential a this to platform,

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about for thinking data XXXX and at on ASCO, as it proof that deck transformational XXXX for what's highlighted year for the Constellation key well fact and XXXX, a ASH. concept presented generated So, by of CPI-XXXX was quite EHA we

presented patients to the a featured potential second improvements, ability Data bone line in fibrosis symptom CPI-XXXX's that increase, benefit we a reduction, and on and of observed as marrow CPI-XXXX's impact setting, provide ASH combo therapy at where improvement, we in spleen both as hemoglobin potential monotherapy. signals

to demonstrated exciting out from cohorts XX line were we also able XX preliminary response TSSXX a rate patients, point. patients. in out XX that data first time our achieve JAK-inhibitor-naive context, that patients at in to the well XX-week We response SVRXX we presented In XX as as of of

also in capped our We off offering public in December. raised by capital XXXX

new adding molecule portfolio a our expanded the clinic. by We into

second-generation is expand As inhibition. potently, This just as EZHX has not to inhibitor. potential EZHX, EZHX to us I well. CPI-XXXX been but durably features mentioned, position molecule with These of designed a opportunities the engage very

to continuing And as company, in organization grow we development parameters forward to the And the we've in lastly, well. organization. capabilities look the our other in particularly expanded

to CPI-XXXX our to a development XXXX begin Phase integrated in on to in We will further first-line we that plan will a study build begin MF. and company. expand pharmaceutical Moving fully With goals, infrastructure we mind, start X organization. a for to our commercial create

meaningful well. generate continue programs to data other for will as We

establish also next expect decision make cancer. to our enable data that the And we CPI-XXXX X go/no-go us for year. anticipate dose for We Phase later recommended in will CPI-XXXX prostate to this cut a

over progress time. identify the candidates clinic novel our into may Finally, to advance we and aim preclinical pipeline that

I'd on Enrollment track. program CPI-XXXX. update remains Please detailed for more like this turn provide on to X. to Slide a

XXXX. of that data preliminary in symptom December we showed JAK-inhibitor-naive response In rates. the about excited spleen are presented ASH patients, We and significant we at

second symptom bone also hemoglobin We not additional cohorts, we saw in improvements. including signals spleen only increases marrow where but fibrosis of in our potential benefits, and line disease also data in presented modifying effects,

plan including as We present Meeting data June data in to European to XX XX data in a second-line on the as JAK-inhibitor-naive XX present Hematology data CPI-XXXX Association to of this plan monotherapy. at Frankfurt to in additional We XX XX-week XX-week as year. well patients, in patients, additional

in that like we expand to our XA, have cohort highlight decided I'd Next, to transfusion-dependent Cohort monotherapy patients.

for Rux. enroll expansion we to patients. XX This up Cohort to transfusion-dependent similar made to that CPI-XXXX patients is now will the added We was in second-line in XA

In in was at achieve least of activity meeting to transfusion the patients transfusion dependent independence. two out conversions specifically based both XX on the a threshold pre-specified cases, expansion our protocol, first

And expanded continued if reflect regarding product X, well. previously JAK-inhibitor-naive patients expansions we recall that These enthusiasm Arm our of as potential you candidate. the our this

addition or over treatment. there the either be no must be to both the markets, scientific debilitating be that also condition and the satisfactory on method seriously pleased the we received new product existing for to Europe. in is for In prevalence treatment must announce designation these drug of emphasis of the or significant demonstrating on also two or diagnosis, We and the designation EU, of criteria, are orphan United States the CPI-XXXX in treatment orphan of must In the benefit disease. life rationale drug prevention threatening in the

our in JAK-inhibitor-naive to year. plan initiate ruxolitinib for a quarter our forward of trial a potential our coming discussions path including randomized third CPI-XXXX refine help look registration global These with CPI-XXXX regulatory Phase clinical XXXX. agencies to patients the CPI-XXXX, plus discussions plans in the will for X We of in

which X well the on is in Phase again, is to for slated XXXX. way begin CPI-XXXX myelofibrosis, trial is the quarter under randomized in third of planning first-line Finally,

We Patients in population, ruxolitinib like be fashion. or MF would our proposed JAK-inhibitor-naive first-line proposed vera. polycythemia I'd a as X, in randomized placebo Slide MF design. from to On plus plus primary studying blinded to progresses CPI-XXXX you essential the the thrombocythemia then ruxolitinib currently or patient that clinical defined either trial or show either

weeks. proposed the the would primary shrinkage We endpoint XX be more of that study XX% spleen in at for or

weeks reduction scores XX% would a at XX endpoint. TSS addition, secondary in In be

We this meetings discuss proposed regulatory will during with authorities. design

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likely Finally, About potential MF there ruxolitinib or some ruxolitinib, for with I'd like of who of their that start them these are many at about patients two-thirds will these of worldwide. CPI-XXXX. We are intermediate believe altogether. some We diagnosed about are opportunity dose stop half point, patients patients to highlight actually estimate XX,XXX and reduce at at high-risk.

ruxolitinib. that addressable patients, many plus data be population start could CPI-XXXX with currently who if starting CPI-XXXX, of would we Based have to-date, ruxolitinib, market that roughly the We are we envision for these that current approved, patient the taking believe on generated Rux. could the

developing the have to we efficacy patients We also the that if to treatable from because and that include around don't perspective, anemia. there safety opportunity of an continues data both hold, exciting start concerns population an to ruxolitinib, believe expand could a that been be

We also aim CPI-XXXX stopped to with monotherapy. treat who ruxolitinib as patients

So, opportunity. with could potentially become care of standard we that expand the CPI-XXXX of new part the overall in mind, believe in MF and

please to Now, Slide turn X.

number HX androgen with gene histone is transcription. franchise. is Cancers found of to signaling discuss like synergy a methyltransferase. in different trimethylate oncogenic including to Let's role EZHX EZHX, and suppress ways utilize KXX, cancer. drivers Its receptor a thereby EZHX have our prostate

tumor with ways like solid combination the such number to properties inhibition, of may and in synthetic drug including believe and as in We that EZHX that CPI-XXXX's be desirable a in there androgen diseases EZHX is lymphoma, are where EZHX in impact patients prostate can tumors, mutated different signaling resistance inhibitors immunity, lethality. also context, cancer. hypersensitive receptor are

we'd like is our that may how engagement, And tumor potently, pursue, some we've patient CPI-XXXX, However, more to EZHX larger durably just over but solid EZHX target designed context this in require populations, much additional inhibitor. we time. as second-generation including comprehensive not

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our AACR with as in who focus of enzalutamide at androgen overcome patients with were in or to like specifically in signals from to a enzalutamide that receptor inhibitors Xb Phase with showed presented the We inhibition. to CPI-XXXX in to activity or previously setting. – treated second-line I'd turning such XXXX signaling abiraterone So, either combination EZHX is CPI-XXXX, study data abiraterone resistance

What rapid trends durability either we rates. response towards had deep saw or patients was Generally bifurcated progression. responses with

X interested time to measures and survival. durability, progression radiographic as progression-free the our in such So, Phase of particularly in are we trial,

enrollment study I is As in that now mentioned, complete.

the Over will signal the cut, and make next CPI-XXXX analyze go/no-go few data a clear forward. data into decision on moving months, to we take will move A a X. be Phase required

XX. Slide to turn Please

to So, molecule the be a believe that moving has inhibitor. potential best-in-class EZHX CPI-XXXX, on to we this

As I of inhibitor EZHX. but to CPI-XXXX mentioned, be also potent, a a durable was designed

potential this generation patient for CPI-XXXX of first come In EZHX months. may us the EZHX the fact, to doesn't populations potential a that molecule biology. that it be into when mind, And biochemical different we could assay, to extract with This accessible in full not expand inhibitors. off with allow that has EZHX in binds believe

are a study. We assessing Phase currently CPI-XXXX X dose in escalation

We Phase our cohorts of expect sometime X establish thereafter. expansion a we to begin second year, Phase to half dose the in the then X will recommended target shortly and

the include are CPI-XXXX development we Some We'll plan further recommended the of of the exploring biomarker-driven around elucidate strategies, determine the X context as assessment mutations as we ARIDXA. such Phase dose. like

turn Slide Please XX. to

summarize like of the milestones in anticipate that to Finally, some I'd XXXX. we rest

important we update at to First, for have an CPI-XXXX EHA. plan

on XX in XX to patients earlier, discussed patients XX-week second-line. we As XX and include data in this will to first-line XX

start to third X year. Phase a with end our by the the quarter of clinical plan trial the further in XXXX, We of update also provide and CPI-XXXX

on for around providing on anticipate We half in X also aim a to provide focused year, an program decision update on the the including next of timeframe. the our CPI-XXXX recommended dose. Phase CPI-XXXX, the mid-year We primarily an in steps establishing second update

runway. results will position and our Emma? cash now, discuss And and Emma financial

Thank you, good everybody. afternoon and Jigar

So, Included of per of for of $X.XX the share or $XX.X our were results or those fourth quarter $X.X per stock-based the we million in $X.XX for of the full-year. loss line fourth with $XX.X million in and had the net XXXX $X.X full-year, quarter in compensation share million expectations. in million a and

and We operations organization fund trial to commercial into year-end to building CPI-XXXX. to these plan CPI-XXXX $XXX.X Phase as to Our of believe the cash, marketable X the needed cash and we of securities start launch Sufficient, resources our were to use fund XXXX. equivalents, half clinical to second million. our

Phase well Phase general X/X CPI-XXXX CPI-XXXX, of we trial the for In funds compounds to clinical pipeline for complete X and operations. discovery as preclinical trial ongoing have support and as and addition, our clinical the sufficient some to

I'll back turn to Jigar. call over that, With the

open please up Emma. to you, line. to like questions. Operator, Thank the We'd line the open

Abrahams you. Instructions] [Operator RBC. with from Brian Our question Thank comes first

Your now open. is line

bar of me, the mentioned that you you Bigger I criteria question Hi guys, ultimate picture, couple study? any thanks XA. Are and wondering, questions endpoints for this this the that unmet expansion KOLs on for will from I taking well? beyond important feedback population? for guess and/or potentially all congrats ARM your there this XXX, expanded see transfusion progress. off on what's whether my from as not accelerated even A or be have I'm data then to refractory starting the of as enable could more the a in follow-up. to arm at And combination the potentially – or look arm Thanks. could be what's approval And latest regulators independent need

question. thanks, Yes, the for Okay. Brian

little are I of it's endpoints novel points think approved patients. reflecting not us the refractory benefits endpoints needed. the in to that fact, post-JAK-inhibitor that maybe about assess to could question really but in the allow dearth to relapsed a missing being that's MF. the that products provide rather patients, fact that novel novel may kind strategies necessarily benefit important And bit to these of mechanisms be these I in And a context really of think the context think just on

spleen specifically, symptoms comings that refractory second-line and or population. have And both in short patient

worse, that early so, a that on of on in that improve, that of stratified know to with standard we assess as fact fact be is be cohorts limitation getting a of a may be in care. its could naturally standard realized we doesn't major therefore a as and endpoint something well patients, result, kind a able and problem to, would And care, that referred our own to as prospectively hard something endpoint, these as for novel of be

expanding question, ask and by the we're that's to with gives goal So, expanding possibility the us to the of of the cohorts. data ability mind, that the really, It these in we exploring really and cohorts. to are kind why generate these

KOLs its and really patient view based own showing Our sufficient, that, with is on discussions simply on any is necessarily and not response needed be with erythroid the own unmet need, an direct kind from our assessments feedback not regulators, like. may of what of that's but

then you And quality combine with the function really in be transfusion the so patient's not in a impact but package. improvement, system and an disease that it's simply combine kind the erythroid independence, symptoms, and heme of hard response true modifying then that the compelling also health of – potential on bone but life, would spleen the including like showing and impacting effects starts improvement with pretty enough, form improvement measures and form to of marrow myelofibrosis, fibrosis you

other said have all becoming myelofibrosis does chance having that that regulators precedent. that, transfusion-dependent we're seem and The context, ourselves more of discussion. just using hematologic giving so transfusions to conversion in interested something not do to Now, in have are really be a

it's I you efficacy about to to might much more to but out Got then, think enable the it. you proposition, you're of That's broadly, market potential you here could sort would an and a very laid early of a about really pricing know flexibility have future think there? potentially existing think revenue to helpful. and Or one therapy? myelofibrosis. from you go kind that show as as Thanks. more value the need sensitivities add-on, as do comparable market me, addressable what you set different of pricing, from in about And described pricing curious, you how thinking obviously I'm standpoint? the Is just opportunity

Yes, you. thank

think us to certainly pricing. be I assessing closely I think right. to we something as program the comment little it's continues that you're early but, pretty a on will develop, for It's

going really how patients on that out. on that drive where kind these could of all impact dependent it's decision, I much ultimately be having to we're and think that shakes

thanks again. Understood,

Thank you.

Our from next Devarakonda Kripa question SunTrust comes Humphrey. with Robinson

open. now is line Your

trial plan taking you congrats so cohort one for a question on you guys. my first-line the of as in to mentioned XXX the and that you've in about expand Hi, well. to presentations, MANIFEST Thank your progress. all patients much Earlier

you're – approval it Assuming that, the that factor this that's a trial there is expanded how that your is you accelerated is a about is with FDA, us potential thinking of X initiation with – also you you if the cohort? to Thank walk your from And would meeting of front-line And the discussions third that in so have for can case, possible, through the the gating in plan of much. agency? quarter? ahead Phase

kind I X pretty last mean, that's before I'll maybe to need start. Yes, assumptions design the overall the for since we're take of one first, yes, trial we straightforward I and the making review think. that Phase the we

and way and mentioned, in that be the something timeframe. parallel begin And we us of X plan been the enable Phase will third in the of QX do under enrolling start X the quarter. patients so we've processing sometime But study that I to this year. the will up And are well to as get in that up that Phase that running of that course over half to first

again, that think around to X with transfusion of we is that gives pursue at think Arm Brian with for that. potential and trying we've this the have to be opportunity for having generate have to going patients is something potentially the to think be sufficient if rates approaching discussion, chance the and XXX we us trial, able a path, like maybe have would discussion, to to XX didn't answer ruxolitinib, north ourselves the similar what be that I I achievable to least basis could upwards to that here what a saw think that we significantly this done – an were regard into gave that we it's response given With dependence accelerated to discussion approval, patients

a been precedent not where There lot for some scenarios path. some that seems there analysis to have be recently, Again, traction. more of

And and so, best ourselves we'll just the put comes take possible. in that as it position

And you. question. I quick Great, thank follow-up a have

any in is anemia. designing way about pivotal your active the population Is expansion? pivotal so talked expand have that the an You representative opportunity, patient they the of there drugs, potential trial, ruxolitinib process you're on in such might especially because the get thought to patients don't

the of actually include no is Yes, I label Rux there these doesn't right. – exclude think patients, –

more So, that know until resist take practice and to just hemoglobin I they think levels they general for where the have so to JAK-inhibitor therapy particularly using a potential of kind it's just is to drop, physicians there try it in patients. anemic while

that have so of fibrosis kind the be on driven we And is, improve that physicians knowing JAK-inhibition, help to driver compartment. progress capitalize from feel that associated myeloid the they to biology something CPI-XXXX that marrow we're bone toward as patients marrow more that Rux, comfortable improved and bone counteract are the is marrow if toxicity that seeing a may on thinking as compartment, that allow the be foundational could that the bone by to might in well effects potential putting further

Great. Thank questions. you my taking so much. I appreciate you

you. Thank

P. question with next from Our comes Rama Anupam Morgan. J.

line now Your is open.

guys, hey on for for Anupam thanks This Matt taking is tonight. question. our Yes,

anemia we've one been of Slide on like to X, we've in be seems but opportunity done, across is potential thinking and But the setting, and which is work big seems back-end, from alluded for potential expand just So, to it treatment XXX is growth on from about it I in pretty the factor front-line the there. and it us, particular various lines going front-end treatment. think the a duration the like there myelofibrosis key in to you the commercial

super So, quantify, much you that the And much. Thanks helpful. able that's be if standard treatment extend your the to to how in be you're care, just to over current might thinking? the that if with by extent wondering line would of so able

Yes.

lot. a So, thanks

to, keep of the which that, points, gotten pathway achieving but perspective. not and result it's I that on sustained to being the kind the of is going the far at discontinuations avoiding improvements It and of more insightful also XXX is back think than also as foundational accustomed a point. are gateway spleen they're itself, just data coming of kind But at a looking that. kind we're very disease we symptoms think precisely that's are a with regulatory what we've to from anemia,

the kind those about we've that's to see driving the about marrow, with fibrosis shown that's data these of of of marrow bone bone bone We hope changes. how started images through that kind supplement to translating additional the we cellularity within into marrow, in past data to And mechanism some around of effects. the that

so also [stating] it's really these anemia, and And hopefully can that information I enough to how and fibrosis we treatment. not think a normalization just to precisely but it's improvement it's, reversal off a lead that patients to driving an that. biology of of last myeloid longer duration have of quantify don't also long And in

several Some of cohorts have been the the years. patients that in second-line now been for we've on treating

of transfusion had these pretty patients Some were and expectancy. short dependent life

but to could that extend these learn pretty And patients. treat so, that's as to comforting quite for we potentially durability it more continue some time,

awesome. Yes,

the to Thanks the updates of guys. the forward in rest year. Looking

Okay. Thanks, Matt.

Thank you.

Maurice question with next from Raycroft Jefferies. comes Our

line open. Your now is

the on questions. and progress Congrats thanks everyone. Hi, for taking my

So, a single study could it the in clarity X XXX discussion to regulators. serve sounds mid-year registrational as the patients whether in you're arm like get going with on Arm

the registrational based a discussed be the will as clarifying, well expansion also on in just meeting? Arm I'm your X path So, second-line in

our to-date endpoints what X, agency's the multiple and design of of kind that is looking of the discussions, X, potential of forward be be those all we there. and for that but Phase that data Yes, as understand on and Arms having. X using buy-in to we'll on design we'll X, randomized of I discussions also we've various and review components I paths the the We'll first mean thinking there's compiled specifically, part the mean, discussions across some guidance additional

it, And if if of some would what about quick a mutation you then just could enrolled options Got XXXX. with consider frequency and that of you I'm ARIDXA okay. the the XXXX? just any with talk you've that follow-up on combo the wondering is, patients and

one mutation actually a the of all-comers. in of escalation portion is in the ARIDXA most all is study so cancer. mutations of XXXX frequently is that frequent Yes, found dose the cancer. our It's

not yet, enrich And haven't skewing so, study ARIDXA we about still while to happen those the kind that and X to learning be surprising we mutation. just it of portion anything patients, enrolled necessarily we're the the in find of described if that some about kind for that, Phase specific specifically wouldn't of but studies patients we've we're

expansion preclinical to for is of X established various high likely us, information ARIDXA would some pursue. very of we've interesting one already the It on we've to other cancer cohorts still of that context in we'll us, deciding recommended provide our mutation expansion identified interest once and cohorts the is that in of course, bladder cohorts be would that be what dose. results with we're more the would we the expansion And on And XXXX. that Phase and

you very Thank much. it. Got

Thank you.

Our next Markets. question comes from Do Kim with BMO Capital

is line open. now Your

Hi, thanks question. for my taking

on to the back go criteria First enrollment I first-line for to wanted XXX, patients. the

have anemia, toward changed less You that outcomes? did characteristics any patients baseline the enrolled allowed beginning on you in the wondering an could they maybe if you the think later are and had those impact differences noticing cohort for whether severe not have and was arm, patients first-line disease, that that I other and

think to Yes, originally started It up anemic ahead population to I to investigators original we were of and from criteria I and some enthusiasm of the was to for the therapy. there only. was After for who label did lot go kind treat patients the traditional what's a the from so JAK-inhibitor baseline, mean, part patients liberalize did of that at Arm we effects, essentially we not open our see think, anemic look I enroll enrollment designed X. criteria of

or that baseline – should respond you there that are, relative we're I about not I would I major we that don't sure should be think hand-pick not So, patients characteristics, differences to any thinking we – better. mean, of I'm to therapy, reflective are physicians the be that and on trial. the clinical who therapy, anything, a are seeking if benefit, have patients are are shown patients going experimental of there choice care out these that seeking rather these survival are but kind standard an mean trying of

likely is makes us kind the but if So, of and more perhaps as them nothing has be kind of We've across look correlative parameters, continue that a responsiveness being with more we'll inclusion response. that's less with range overall, to criteria, at data different driving characteristics, of to more as something seen popped scan anything well and things assess down you baseline that to and sick, out you patients. that for various

I think clear everybody. that increasingly will become to

Great. that the and for measures decision, TTP biomarkers Thanks, Jigar. there clear And a your XXXX, like? you look into will in decision? factor would go/no-go what when make signal hurdle or that What's are other

it's defines [indiscernible] then upstream AR you up safe that Yes. And [indiscernible] is really a metastatic kind all that, and We've of some being of think agents dynamically second-line. would the then the out used them be are in what it got I cancer evolving used the and first-line move area. with to prostate in to end

kind so And evolving all a dynamic that's of landscape.

You and setting. chemo, also studied have in inhibitors PARP various in also being that second-line inhibitors, context checkpoint

be data, kind into well control at well arms of competitors historical benchmarks, decision. of And study, as to that our as make built evolving the so that as data from we'll as own we've looking kind as

for multi-factorial us. of – not type decision it's a it's So

randomized that clear is subsequently Just to patients. but shows, a enzalutamide, also that months as want for in the reflecting then these from first enzalutamide, of significant I the this, think XXXX see started historical instance order two separation progression study is after that we went where looking were three we we published on we to to separation for would clinical time were on with data order a be arm, clear the in we into enzalutamide the

showing for. for also could data forward been path kind so, assess some that have I've over to of of that improvement some to a mentioned think of EZHX assess that want other prostate the And would these shooting latest we're be classes in of published therapies what inhibitor be something the then significant around cancer. I that And we

this you to if Okay, And be with first, don't have think in great. you development will it XXX all reasonable XXXX, that cancer you continue prostate pursue since would experience?

It's possible.

up with I trial here work. extremely think is we rich translational that I deep over including very patients, mean, we'll have the set XXX well data.

really mutations One proud for is that to about learn of that the to we've we're interesting things be follow. made we us about various think investment and the that biomarkers could

hypothetically, we a that so if learnings not take to and And of as in we was intriguing, terms hypothetical. all the XXXX apply clear but very those standpoint, signal a had, those could XXXX

And do anything but like out. ruled so, yet we it decided haven't haven't we to that,

for Thanks my taking thanks. Okay, questions.

Thank you, Do.

Thank you.

Mike from Baird. comes question with next Our Ulz

Your line is now open.

for Hi, guys. Thanks and progress as well. the taking the question congrats all on

Mike. Thanks

can and versus just expectations? Thanks. maybe I'm uptick was patients? just And enrollment ASH curious, current question XXX patients for how just XXX your front-line there about that's you study talk the if tracked in And another Maybe the you in maybe of post MANIFEST here, just particularly the target status any data? of versus your

lot was lot there made the and who post Well, excitement, from of generally, but I and were it excitement ASH, more I a there think there a been of a we think of as aware was even enthusiasm there public, has Yes. enthusiasm lot was data, the more pre-ASH broadly. investigators certainly,

maybe, think, I all I it's say pleased can expectations. enrollment on is our we're really meeting really and that,

And Got follow-up just maybe on then, a XXX. quick it.

Thanks. some other considering? might You talk expansion how can many prostate, mentioned about maybe you you that bladder, are some or considering maybe be potential others potentially So cohorts? you maybe

EZHX expansion to of both that in decisions well the that well as for haven't pursue. are are are the think, move among going kind considered that we're our into inhibitors finalized clinic. cohorts we There things have as EZHX, known indications opportunities been several we And various not on yet which

which we disclose that make to which any to of we'll So, beyond also your CPI-XXXX be that details we've but not and the is, more bets opportunity, a we're best-in-class about utilizing in test strategic contexts, inhibitor, things driven of of infrastructure EZHX by considerations around built really and potential like ready hope largely that, the various cohorts. some quite kind the kind bold really expand

Got it. Thanks again.

you. Thank

from Our with next comes question Frahm Cowen. Marc

Your line now open. is

for Thanks my yes. question. Hi, taking

some more time and on planning at the well, the First, understand you're the expect you've I seen, already that give update enrolling them presented and points just already at the the data I will you've XX-week that to points? just before, been any patients we presumably earlier have like we've of that. like hit see with places EHA, characteristics. the on, patients guess, get XX people that week that EHA to we'll Should as But time already in baseline were of

So, earlier than data? the XX-week

Yes.

I possibility. we've assume shared to past I the reasonable think, that that could a know be it's that Yes, in and

I haven't decided EHA. perspective. data feel exactly that XX be that's We threshold. out We important out there will data importance We And presented regulatory from on a behaving. there. of time kind a crossed important that at certainly would do inform what We point will to kind important know patients if think the like that really based drug yet is its have XX-week XX will think of it get to how there the is be that

think share what's we'll assess to everything of kind different we So, category. that see meaningful, into that with falls and you what's

can be in baseline prior given of even – and would platelet XXXX, the I whose maybe with to safely anemia as populations Okay. was lead and maybe about people at within more questions well. anemia able more changed on baseline to that but trial, that? And then the terms all? wanting benefits dosed combination on show this platelet you're think has the people and have counts Has that counts just enrollment be in seen enthusiasm you would that low on to with to enrolling as

there been again, of patients any baseline a selection hasn't with bias characteristic. any Yes, particular I mean, toward

we've think to certain platelets, stop minimum welcome for enrollment as And for wouldn't criteria patients I long So, qualify as and set example. they we that. enroll

And so specific been trend necessarily there point kind other, the I or one with – to that. wouldn't to way regard of hasn't any any

given at clear – if forward it follow-up on that everything benefits, Phase – still also from one, benefit, XXXX Or with result one proposed the X also this safe if would pivot to great. with I’m Okay, guess, use sorry, setting? would molecule? – last to an you if looks have still the that proposed in had a touched that with recommended XXXX pursue that see ago, intermediate that a point, even you given you have look franchise, then you of benefits EZHX given you move XXXX, then ProSTAR a if XXXX and proposed signal, with but the you maybe XXXX, I minute you And Jigar, dose, with could you

that's data and I I mean, shake if exciting the think to into Phase determination. I that XXXX, move it substantially how to a out]. to on results the see we the depends [having ready so still just think data have just we're what make X wait and along further are

you. Thank alright. Okay,

with question next Instructions] Thank from you. [Operator Silvan Oppenheimer. comes Our Tuerkcan

Your line is now open.

Thanks for quick have and taking question congrats follow-up. quarter. I on and just one the my I a a have

see enrolling data and patients expanded the did additional you where As that have do these sites from are centers or sites? you that front-line cohort, additional add you

question, repeat Sorry, Silvan. can you your

Will EHA the – are expand you will you sites you from front-line if did did And see in these additional at when – add or data number cohort, you just expand we did additional there sites, sites? existing you myelofibrosis new the sites?

rolling site have data we've more beginning activate kind of sites. – I Presumably, been, new you'll sites we've from activation of many new sites been mean of and thing. of that we'll of sites kind haven't the activating continue kind it's see the kind from study is and to of

that’s kind necessarily do. kind molecule of to how that in the to we the linked study, And with so are development more next study, of as of current the expansion, this as aiming well just but we progress the

more site, increasing with were a already of there that, board, kind of on patients of instance from sites coming early already for represented an are The that all will from be definitely active. they proportion we're coming more diverse with not and more sites. So, patients that pretty sites array coming one

regulators? of is I probably second-line terms not still the confused the I'm us exactly Alright, are EU? And the in with between of kind bit for could the you how differences? discussion great. your or I as U.S. the that just little believe Phase and What your and some Is work or on for expectations outcome approval they case what another the X, would front-line? about, what X, What's baseline you trial with share a then, presented think Slide the of similar it And indications, approve you today what of think for X baseline kind like do or accelerate Thanks. is or they second-line?

we've differences with it's, and Phase X of between thing I is that the the be start that outside want should assumption the address question say is confirm the about Europe. kind as we requirements of to I'll for case. certainly that, maybe we'll that mean, but you U.S., first maybe designed the with And U.S. kind we globally. regulators I approval the think so believe that asked meet I'll Yes, to that Okay. meant

a kind development, think know generally from less approvals tends in meaningful. a think, and more there kind endpoints stepping of in that, back as randomized surrogate based So, of likelihood I drug much of you Europe to of kind I on studies be are to achieve

I me mean, to we be asking case so, that if you're expect what well. this as context in expect, we continuing And the

regulatory to U.S. there lately as discussions harmonization and authorities, that, that said Having seems well. kind of around understanding those more between and bit of kind seek a to ex-U.S. we'll have be

they discussions that that are our if if So, mentioned as more but of to arms. bring currently that's pursue, there we about Phase we information for kind and least I based think And is of strategies likely full or to just all there's kind think X there's potential earlier, again, at basis And not be we'll again, hold, approval. of to those up, meant those or up sum the randomized not accelerated on we discuss to whether not. possibilities three have see

So, discussions. those a putting in we're to ourselves just position have

Thanks thanks. my taking for questions. Great,

Silvan. welcome, You're

like the remarks. Jigar over any closing Raythatha you. further time. I'm this any to would at not turn now to back call for I questions showing Thank

an to well forward everybody in support appreciate as call all and company, mid-May. thank just to say to we quarter the been to really look as that's of first on you update provided wanted in us, interest Okay. the our you I providing conference for joining our the call. We

gentlemen, disconnect. now you conference today’s call. Thank may Ladies concludes you participating this and for