Constellation Pharmaceuticals (CNST) 10 May 212021 Q1 Earnings call transcript

Good day, and thank you for standing by, and welcome to the Constellation Pharmaceuticals First Quarter 2021 Earnings Conference Call. [Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Kia Khaleghpour, Vice President of Investor Relations and Communications. Please go ahead.

Thank you, operator. welcome XXXX conference performance. financial and Constellation’s to everyone, quarter first results morning, to call this discuss Good and operational turn X. to Please Slide

including our with to forward-looking begin, today uncertainties. to Actual we Chief I differ to Jigar XXXX. and quarterly out Before materially on may Please financials. Raythatha, our due the Reeve, want Financial certain our our risks other who on Humphrey, including Officer; the morning, will important for XX, Slide update most will the of to Jeff our potential which statements, that joined include discussions those company’s well This as as X. Form company’s Commission, on Exchange Chief described Emma results quarter factors, and Chief are the Executive review uncertainties clinical Dr. Securities and in XX-Q important various turn subject point and we will section recent March in by the filings Medical Risk Officer, report presentation programs, who Factors our factors risks, call Officer, ended are first the you

our also Slide I portion by joined will Patrick Scientific the call turn Dr. turn Q&A will We for Officer, X. Jigar. the of Trojer, Please be call. now the Chief to And to over

company. commercial poised biopharmaceutical Constellation you, integrated transition from to Thank stage development-focused everyone. a to and is good fully Kia, organization a morning,

trial Our enrollment lead asset, pelabresib, underway. a III currently is and Phase in is now global pivotal

of MF and of for patients backbone make the to pelabresib standard transform to the is care goal Our therapy. these

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paradigm believe for Chief our Humphrey, of the I treatment term, over the this pelabresib updates Officer, develop Medical myelofibrosis further share that, our the therapy on turn a call to disease. Jeff programs. clinical can that long potential to the With debilitating with you Over to we shift into with we will backbone

for health Trial in underway have Europe, We’ve of the with we’re board turn investigator sites the trial of received the level the pelabresib. Thank Slide many and in is you, initiated MANIFEST countries, trial, in some and MANIFEST-X Jigar. on ethics Please pleased Phase academic in dosing and of we’ve III centers. authority brought committee U.S. the interest approvals and already X. been to both larger

lockdowns. COVID-XX from however, initiation seen backlogs, have impact staffing sites trial country as have, shortages, COVID-XX We some experienced overall clinical certain and prioritization trial on-site

visibility the more third the update expect online. sites a in quarter further over We provide expect MANIFEST-X next come and we execution as have on more to several to months,

related last most genotoxicity that been study efforts, call, we reports, reports on FDA Regarding date. our including I’m to submitted the without study now to comment have mentioned earnings further from pleased agency say to the recent

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the Phase II study. to Turning

data. Association, We additional our at data MANIFEST XX presented expect EHA, on Hematology from focusing analysis cut September trial or translational be the on based to European

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cytokine baseline mutational assessed cytokine pelabresib analyses. We extensive during baseline, changes and level have treatment, at assessments also level pharmacodynamic

X In present will other addition, posters. we also

splenic of will and anemia seen Arm assess and poster The will present second the X MANIFEST in from by poster response response subgroups Arms X of MANIFEST. from patients the X first

generation time on designed long Moving first and CPI-XXXX exposure XX. residence Slide absence on EZHX of inhibitors ways, program, to of target, potency, number on levels We please EZHX to of our including to induction our metabolism improve turn auto in a time. to maintain over increased

I/II extract enhanced Please our therapeutic turn We improvements, potential and We based patients CPI-XXXX with evidence advanced multiple with the historical Phase Slide of first for hematologic study to I CPI-XXXX generation may molecules, recently of portion last pharmacokinetics completed observed the in to PK As first an to biology. Phase I auto of discussed call, our on of inhibitors. profile comparison the CPI-XXXX XX. these metabolism. generation the solid earnings EZHX date, of pharmacodynamics on no Unlike indicated and by induction tumors. Phase of improvements data

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ASCO oral profile CPI-XXXX established We data manageable. will The PD a Phase milligrams was XXX in safety Additional be our upcoming presentation. line dose dose. in once-daily the expectations of and II as recommended with of presented

additional -- with share at will of details Phase the the you poster from We portion study I the ASCO.

Slide XX. to on Moving

the CPI-XXXX Phase on cohorts for or lymphomas. following II endometrial plan cell mutation, activity open cohorts refractory and first ovarian relapsed known of monotherapy For ARIDXA tumor are relapsed relapsed the the and carcinoma, and of portion evaluating patient. with types, dosed clear we’ve all in carcinoma, we the carcinoma urothelial antitumor enrollment, the of study, relapsed These

are on to patients planning per We enrolling XX cohort. up

therapy As goal monotherapy signaling now cohorts cancer enrolled. malignant who least least line further the on we of known have tumor and part will X of expansion patient activity to metastatic evaluate our who turn castration-resistant I and X call receptor to progressed the over BAPX cohorts prostate and antitumor therapy. of safety add mesothelioma at have the on androgen And development The at of types at progressed with plans, X to plan loss, CPI-XXXX the prior future taxane-based Emma. is inhibitor for of

Thanks, Jeff.

a with Moving of net our expectations. Slide financials on the on loss quarter XX. had line first the in $X.XX $XX.X per We or million in XXXX, of share to

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we we for addition, clinical our compound progress and complete as to operation. Phase funds preclinical of pipeline well and CPI-XXXX, to discovery corporate have as believe the I/II trial general In sufficient fund

our on Moving milestone Slide XXXX. position XX, we’re pleased which we’re with in. for to the corporate shows now Overall,

update clinical year, trial, translational MANIFEST, time with the the clinical of our II share at For of EHA expect and we you to a midyear with the Phase this in remainder by from updates a further update end year. the frame

also of to an potential aim indications on provide the by new update We year. end the

announced For the midyear update the year. II plan of I of by to those expect And an expansion the for now the That that Jeff an by provide provide cohorts we’ve concludes from ASCO. our at from opened Phase this morning. we to as CPI-XXXX, earlier, up prepared cohort, we Phase update the portion study end remarks

please things I’ll back for over operator. you line open the turn questions. the So to Operator, could

Our [Operator Abrahams comes RBC Capital Brian first Markets. Instructions] question with from

what and the the [Technical And what dose your what you’re the recommended you’re Difficulty] guess, of II choice observing XXXX? and with with -- bit efficacy and how into? guided -- the populations you saw going on XXXX. PK/PD you how that biology, more differs observing observed from what a Phase you’re I clinically safety

I the repeat missed of it? first Could question. your you Jigar. half is this Brian,

Yes, absolutely.

the curious portion? clinically the PK/PD, the Just the XXXX. observed you’ve on that wondering how -- little elaborate just how you’re more if then a from is selection choice of with II sort guiding into of to And And for seeing go differ efficacy dose your biology, XXXX and safety you’re and you may populations clinically? what bit what could observing Phase

Yes. Yes.

will presenting color. give the We of but a full be you can little ASCO, bit maybe Jeff data at set

this Humphrey. Jeff Brian, Yes. is

pharmacodynamics guide we did for dramatic I help is XXXX, not and to study know, with PK recommended the seen CPI-XXXX. and with would expression be as response selection I this does dose. consider Phase saw about gene really what Phase you So of our portion, dose II That safety, a certainly

there. find we And chosen have as that safety our we guided However, recommended to upon findings. run said, II don’t typically abstract. to don’t is did we -- information recommended dose Phase dose. of of hard you’ll not lot want selection results II worked Phase on ASCO and unexpected want toxicity a Jigar front-run the ASCO the And poster, We based the

I if add that. just can Maybe to

And EZHX I those to shown change to mind, a induce including think step replicate a changes had with change have, that feel in target in XXXX. And engagement. generation target and ample we’re to able as we embarked level engagement the comprehensive developing really XXXX, engagement of was clinical profile I of with that on preclinically levels difference we the in step we now we that induce with discovering which data vision think can very that inhibitors, target we in XXXX. EZHX type relative of comfortable first we’ve

it. really more the congrats Phase then forward With underway. helpful. could. respect on Got for And getting Look I to that That’s ongoing X me, that presentation. if III to MANIFEST-X maybe study,

initiation, What and -- And given mechanism talk if for on wondering of potential powering expect be an the potentially assumptions or Just TSS. year? there? How were that site latest spleen could the study you the upsizing the next end could be your of of you resizing of about COVID year potential just that headwinds we about should still to on your this study? the early whether disclosure based by thinking maybe

make it to turn powering I’ll over historical MANIFEST me a we data on from saw and rux SIMPLIFY-X. assumptions the the response in of the based But are and of then data Let comments, couple Jigar.

study power later we have and success, best will the the provide and data to additional will on We answers in year. the

you we resizing study. mechanism later again, mentioned, the as the those of think, provide a I there’s year. be for details in would that would And

Cowen and comes question with Company. from Marc next Frahm Our

progress. the on Congrats

safety DLTs quick Just following on Brian’s you follow-up up then I’ll was the one, again questions. And I based what you were? have just observed. recommended the think those mentioned Jeff, pelabresib on dose a were that selected X that progress. on Can say

for ASCO a you thank but see the short No, only really the question, away. we which prefer Yes. is you presentation, that while

CPI-XXXX the Again, profile is coming. be safety manageable will the that selected. So dose for at

our Maybe of preclinical we’ve inhibitors. work what kind just other from seen to or add, on EZHX nothing unexpected from based work

Correct.

you you maybe, then there to definitive a And disclose in the where expect give to is, Or an Okay. be progress? ET Jeff, this and, how on there’s still very plans work guess, do Can data And cohort. really set I that year? be? just going to pelabresib, later just update kind of is expansion it enrollment on much data

Thank Yes. you.

these MANIFEST -- again, we’ll are to is and Arm in providing So update for the X. the that frequent later the amendment on And an be community, will open not it in are patients enrollment year.

for So of the enrollment ET trial now. is open

Yes.

that and towards I patients, think, said of handful that. previously, certainly in hard the possible Marc, data of year, full still wouldn’t be the have we would we’re cohort from past, working later the that a it’s kind in we but

that. view work As kind learn a And frequency Jeff we’ll that noted, as we of to presentation these X were is patients. think, on we have the certainly, looking good patients, of this of cohort about through of things the this I

comes Securities. Kripa question Devarakonda next from Our Truist with

bit in an to about we at EHA at last you you should expect, EHA, And the And follow-up investor do data XXXX. year? presented question little what the talk a on we can especially event more then hosted expect be abstracts? Regarding X like

to addition mesothelioma plan and tumors, trials the ARIDXA in In you solid mutant lymphoma. you in said to also initiate

at your patients early Like too X indications once see you it that Can about know from about agnostic is XA you’re in I these get bit it. you looking Just about total you’re you in? the But are mutant talk ahead patients? or opportunity to thinking little a initiating trials to little tumor talk BAPX the maybe a bit. how ARIDXA, little these a added it’s the proceeding?

you. Thank Yes.

the as reduction of relatedness at in about And really be data of reviewed. is centrally responses in will cytokines, dose a mentioned marrow bone that have inflammatory data around biopsies fibrosis. There’s the That status. that as presented talk well. marrow be regardless reduction bone EHA there cohort mutational data the paired been So of will

really the in treatment. the urothelial are cohorts the ARIDXA those anemia -- that well are comes the the we I endometrial of in size a it to those very patients the BAPX. When tumors mentioned around cohorts mentioned, terms you of some are SEER And about mentioned. is important -- that effect ARIDXA the mesothelioma tumor, interested is solid opportunity, think as database the and very were of patients of uncommon on terms of in are think, roughly in under and the I pelabresib, lymphoma, so U.S. So as mesothelioma in in fairly in presentations pelabresib in X,XXX planned as

but -- We’re with we’ll initial but at be at well, at focus as loss, wild be an but looking looking BAPX. BAPX at BAPX, we’ll on looking type

-- for lymphoma. and mesothelium are focusing you think I on both

are at patients. rate, to there. our XX our X-stage I the response think enrolling observed we’re looking and from there design designed based cohorts on And up as enrollment, plan we’ll development

I couple If couple -- just could of comments. add a a

I the EHA really studies become disease past really I of understanding there think, hand, the these data really the a see And And And that some beyond. have set. some us disease the taking of we’re have and drumbeat of laid mechanisms I of But done, is more will of that are of types that and data synonymous by means. a the that what is we’d at or the some see disease-modifying will be the is data intense the generating of pelabresib what next focus that them mean, -- like what analyses likely out first the team modification. building into of of level. -- been we deepening good to it defining think and we’ve to further Phase for to III start the kind modification that be but on we’ll from kind data X. his year that over ASH in Patrick again, also we with time

-- an of opportunity, little that early of to step in it’s And your that question. questions kind so of drumbeat. is size it’s And around building kind early. in a that’s the XXXX of and kind It then a shifting the -- just good

broad see lot and go. the that ourselves us for really optionality can set you up that taking, plan approach a a where to gives we’re of As from we’ve development

features science the good point. with have We’re a the lead genomic following and -- but a we’ve that following programs well of it’s of commercial should kind of in very been precisely as rationale EZHX total some think this other us at there’s data a early that chosen more significant around presented as to of the We some to opportunity, today. for that define little lot

Our comes Jefferies. next Ho from question with Chen [ph]

be just mutations So, early, across mutations but of follow-up. It percentage on having maybe indications or patients based ARIDXA study? maybe a BAPX your could what

Actually, itself. indication yes, depends it the on

where I loss, there bladder types mesothelioma. they’re think where other about X/X this ARIDX begin tumor them with. of mutations. where certain of patient have particular, patients half smaller we’ve to are past, highly have roughly in mutations, in the to tumors BAPX talked ARIDX populations like prevalent in are but cancer, close There is

In terms than more that targeting, we’re types the have of loss patients mutations. mesothelioma would BAPX of of certain half

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

is I? you’ll prostate timing combine XXX, escalation plan cancer? of have And on to you mesothelioma the XXX care of in First, and when solid with Phase a the initiate of tumors exactly standards dose do and do cohorts what a still

Do. Thanks,

to then of activity very be to some we’re combo we us expect step the have from to would I work with biology care. kind that looking is strong. until to single move And of is with that XXXX, to where like to standard But is activity like it for think gate try studies. we combine agent very into we Where some cohorts see quickly step would of to see quite molecule we single-agent see these it. a to first reasonable the and taken compelling I that generate so ready the think sequence then of combination XXXX

you your second question? And sorry, can repeat

said you’re cancer Yes. prostate initiating cohorts. start? mesothelioma planning When the those will cohorts You on and

Yes.

on ARIDXA the comment our brought I the little view Those activities. cohorts. start exact certainly think than the own we’re time for later we not in were lymphoma things those that -- into planning ready into to a

future. so And update able provide we’ll the an be that in near on certainly to

And MANIFEST-X. it. question a Got on

rate You get that your said enrollment. changes an to is of for impacting addition there you in expectations regain -- opportunity just that that sites? active will for if to the trial. enrollment the is by COVID And had when data speed wanted Or know that

Yes. clinical that are delays are in mentioned, of mode site in and the we resourcing clinical Thanks areas sites I managing the at Most the and it inescapable, activation. we’re trials of in are start-up we’re as trial we experiencing commonly the impact staffing. COVID-XX. and can, of in through question. for that trial COVID included the best mean include is affected site, delays our And site initiation. very limited by and are you disruptions Those site

enthusiasm receiving the on from for we’re pelabresib that from e-mails both the physician participation. However, high patients trial is and for community based

We’re very CRO issue. with to in order closely address our working

We force physicians sites have finding affairs And for new relationships field and sites. with additional medical they’re finding is participation. that strengthening actively a

study So, I at time, provide this later initiating but the we strongly think time. more a at we’re information can

add, I just if it’s okay, just I’ll comment. If

for per se. a early to us little I on think it’s comment enrollment, really

running But really on up. that and comment in up anticipate until seeing up running, sites of we’re has pent-up and Jeff the resolves, and on demand mentioned the we of we’ve sort those that the us picks the for start-up. of specifically site there or rate kind think really patient is seen sites. pandemic it’s think early hope that is really trajectory to our enrollment that been And I kind having enrollment as of then I impact that

previously what messaged update over keep no a provide well. eye it point on of at this And on And an we so overall, we’ll point. this as and coming change close kind the certainly in months have

Securities. comes Our Ren from Benjamin next with JMP question

identify particular? just that. the loss other patients? out remind assays RNA, the diagnostic a there? at might one development sort about a that genes guess, related be works of us does to in the and Jeff, look there of And ARIDXA went as -- the there? of there just plan to a related BAPX something help total standard shutdown in had, how is, foundational rationale doses you you like these in these there? can for you more on are PCR biological XXX-milligram part why, picking Jigar to Is progress. X this presumably of Congrats in BAPX you Is mutation that question is that loss the there profile fit that mutations this these XXX third also or And at? assay and Or Maybe and where Or also ARIDXA in a kind if I XXX looked nuanced you that or

but also who we kind the Patrick So up. of Trojer I’ll have start, line on I’ll to pick ask

that for now, diagnostic I right to premature the need the on the of -- part on answer It’s of assay. of kind question it’s back question. kind think

as cohorts, see of wild determine panels. But kind mutational and included that perform the expansion are think mutations type I we frequently a that. in NGS patients within we are can status these in how the

data we need have that that to we’ll so, kind inform And decision. of the

got On the that kind you can provide Patrick, pick about question what areas? the these -- particular biological if rationale, excited of maybe, and you up

Thanks, question. the Ren, for Yes. sure. Yes,

And and control. termed of scenario control EZHX gene BAPX the EZHX BAPX of resists it’s concept and is restore complex part differentiation than gene in with of program EZHX rather for the complex it case So expression part a rewired. know, would chromatin ARIDXA ARIDXA, where underlying protein apoptosis. proliferation is a take BAPX -- and as complex inhibition the the mutations, from the the promote can promote expression gene And over you hypothesis that remodeling that may PRCX program complex, is creates that gene is of would

other as that just of instance, part said. that Jigar what are Jigar said foundation panels, So panels, NGS of part many the regarding as ARIDXA diagnostic, I’d are mutations add they for

it. Got

checked Okay. -- do One, good you sufficient Terrific. call those confident back time to of think do of on has couple And a go the and yet, box? confirmation had need back sort look or is what wait pretty everything I passed were just studies regarding little And at that like there of Jeff the a comments you feel we the the no -- comments genotoxicity Can that bit been it then regarding more I into has studies? there’s for submitted questions. guess, mentioned additional been color? no still that yet. additional to provide go? a is feel something they’ve suggests Or FDA kind letter some taken you that and that

do take this want one? Patrick, you to

Yes, sure. Yes.

then some there and included common initial positive vitro informed micronucleus have we assays and and that follow-up as And we assay. for out form said X the their genotoxicities X a signal. assay ran. a and ran our studies was sure, the real So our that previously, an we we guidance in had updated signal consent of a that we We investigators, informed FDA. in followed We determined

us with do would that acceptable. gotten be back the to studying, disease we given these asked different. If is regulator would not they of there anything we the So these and findings agency, us. an that the believe they will have to are shared have We preclinical results severity believe issue, the

Kusy with from comes Colleen next Baird. Our question

on progress. all the Congrats

guess, we been can have that of the I any the able enrolled? tumor On what see types patients Phase are the were study, that to And have you cohort? will tumors I XXXX are be expansion the to share -- that able you for portion selective

your at I study. new Phase role also all, It’s congratulations a broad of Baird. Colleen, standard first on pretty

certainly of at of you patient as here are the lots kind it’s enrolled. would or levels. different in that right the interested there’s it’s be possible know, -- also also enrolled. X so a And tumor But for types dose there that Phase we It’s

a so rare certainly pretty And I we would it’s event possible. of in is kind studies, that these Phase see but that

a for recommend for at you’re II helpful. you be secondary hematologic the very dose? the as Phase do same That’s for point, there’s do And going malignancies tumors? Or after, a to expect think this potential solid to Okay. dose you

Phase recommended take safety The the part profile No. and, on the II profile profile. and PD PK of course, doses the in

XXX milligrams recommended carry so previously. Jigar’s patients I therapies. Phase would in refractory that are and echo And comments dosed forward, is relapsed And orally even would once-daily dose just available Phase to the we I lymphoma. all II

So -- Phase as other these the are I patients same not are patients.

Our with from comes Jay Olson Instructions] [Operator question next Oppenheimer.

can expect And an you that build done that about for any you about As label? the pelabresib? pelabresib, data or you you disease IP then the for any patents indication for into work modification commercialization talk continue not filed. evidence about protection the get us how that’s and will you’ve prepare or of to you have that talk remind may And to can additional whether

as our pelabresib. why building don’t if first, call, recently that. company We with -- eventually -- I’ll start? I got early It’s have -- team that Commercial And commercialization. joined be preparing that’s been for Delaney joined be So Officer, and last question the Brendan okay. for the We end still we did start the have we’ve earnings Chief the relatively Brendan of us, commercializing innings who did on will would

working taking are has product that people as steps there. of the with help to a with we appropriate positioning. small the so as group And him stage He well us

as method think patent of a IP significant. terms IP, are also significant treatment we’ve types as of build both various covers managed that portfolio we applications fairly well In to that composition of

of public I think disease mostly that’s And kind I we’ve with think so that of modification, a a making MANIFEST in the that’s in study, in -- of translationally myelofibrosis in kind all terms spent domain. of we we’ve heavy kind taken And of done -- translational biggest work probably this date. in science the -- pelabresib investment to a very kind very approach the deliberate to out

of study to or is so any can And of those mind, that able a part ourselves types certainly marrow the we’ll like findings conducted. of fibrosis set to up like be into the way position ourselves bone in do to And label, as that the goal MANIFEST-X. into include is if leverage learnings with to those help ways certainly to find our us to they

And fibrosis important. the of findings bone the we I in and Yes. the very megakaryocytes and if reduction just precursors that could think in marrow erythroid number both I Jigar, and normalization distribution add. are mean, are

And thinking randomized and might in a that so how Jigar included would promotional future might use. imagine, about pursuing you as might be that be as in be setting we mentioned,

That’s super XXX helpful. on And then is there your any update program?

we I moved mean mean that is that studies. early I just program in days. the certainly into IND-enabling still

the And IND that needed an enable so work that all program. going we’re be to would for through filing

update So now. no on right XXX further

turn back to the in there other I’d remarks. for the Raythatha And are any no Jigar queue. call to closing like questions

joining I just today wanted to thank for Yes. asking and everybody questions. such great

studies. look both really in as We’re as next our patients the as up we excited, it to forward today as on goal nicely well the the dosing XXXX becoming future call, to calls. to in with with as where integrated mentioned to products sets sustainable steps the and pelabresib company And the towards fully a think pipeline terms next really transition marketed we take earlier in well in of really are talking and organization from we

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

now may disconnect. You