CNCE - Earnings call transcript Q1 2021 | Concert Pharmaceuticals Inc

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

Operator

Good day, and thank you for standing by. Welcome to the Concert Pharmaceuticals First Quarter 2021 Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speakers' presentation there will be a question-and-answer session. [Operator Instructions] I'd now like to hand the conference over to your speaker today, Justine Koenigsberg. ahead. go Please

Justine Koenigsberg

welcome update. and Pharmaceuticals' quarter first Good to investor XXXX morning, Concert

Our so you Roger be right will our key prepared today comments Marc then brief first will the Q&A Becker, quarter of highlights; and CEO will into portion we the the our call. walk Tung, CFO, provide CTP-XXX through the jump can financials.

the Cassella, the then our Chief and of Jim Stuart, Q&A joined for Operating Officer Nancy our by be Development We will Chief call. portion Officer;

As with call. Any are only reminder, SEC. would include that recent that, our statements to risks forward-looking in a and assume filed today's description most of to now as to discussion today's forward-looking A to these and uncertainties any projected. the results of no XX-Q about will on found With plans speak expectations, update risks, differ made prospects. our we call those obligation date, be over materially today's may and turn subject future cause Roger. I actual These like from statements statements to can statements forward-looking the

Roger Tung

with development. pleased that be best-in-class which may We're it treatment program, advancing We're filing overall data advancing NDA Thank and competitive And far. believe the as areata you, program the in efficacy anticipate safety with happy date seen to Phase has planned. Justine. we've currently alopecia to early X through the CTP-XXX is shown progress thus the We're committed XXXX. CTP-XXX and very in continue to for CTP-XXX our profile of based the on

data initiate patients to expected projected. study trial next alopecia and with to will design. X track enroll year. are similar our THRIVE-AAX, on X as XXX second The in Phase is this moderate-to-severe areata The approximately THRIVE-AAX quarter are Phase We

present that CTP-XXX reminder, extension long-term Xnd in or recently treatment most number show a ongoing our extension XX X. regrowth medical an JAK data to beyond open-label from update results, presented study which been Summit Drug on weeks. improves a on hair robust have the Inhibitors meetings study our Development clinical the plan during As of including maintains We July long-term

in primary twice looking endpoint study, XX X XX in daily significant analysis at our our efficacy SALT is trials, we statistically the Phase Phase which cohorts the X-milligram differences CTP-XXX for placebo Additionally, XX-milligram and X at weeks. saw the from

take treatment first in There is important by FDA medical XX% the conditions. condition industry epidemiological of of or many Specifically, to XX% becoming are have emotional, or SALT disease of XX. with exert treated of recognized patients meaningful. SALT of than achieved of that patients less disease score than of important proud approved notice absolute XX% is in the other absolute twice XX-milligrams of XX. areata increasingly currently daily and advancing an equal an These less CTP-XXX an on In anxiety autoimmune recent interest psychological cohort, clinically results one and with the results achieved X-milligram X.X efficacy million this to with XX% and alopecia score equal trials, those A presented findings to of represent we treat alopecia enormous was widely greater. impact need assessment indicates most or between including areata is in an CTP-XXX. developed alopecia patients of patients data with scalp suffering Concert for the of It's of associated responsive depression hair from loss patients the comorbid that U.S. approved areata. the and the any to-date an to and robust or being our compound no treatment we're that upwards significant, believe Based XXX,XXX

XXXX. early a with to NDA in continue forward its development We push to goal our file

that continue to For to long advancing to treatment. major Patients will patients and time in be developing future, a our an for meaningful with waited expect force something the to a have the believe effective in a field. We're we invest alopecia immediate intend we areata CTP-XXX. be resources clinically

pause Marc. turn and the Let call here, me to over

Marc Becker

Thank you, Roger.

As our to reference XXXX. XXXX, related quarter CTP-XXX in ongoing The clinical release. results, 'XX during million first Phase period increase found in the were the $XX to was primarily and today's financial program. the I tables review financial the press X quarter first XXXX Research million expenses development same during of THRIVE-AA please QX $XX.X compared

trial increase expenses $X.X and is 'XX, R&D million non-cash compensation. The expect this $X.X external General the 'XX attributable XXXX. for service period were QX as million expenses We increase month. to during higher same our and to for stock-based expenses X administrative professional CTP-XXX Phase QX to second initiate we in compared

XXXX. for per of Our loss million net compared 'XX net was loss QX in $XX.X period million or same $X.XX $XX.X a $X.XX to per share the share during or

cash, first in be This cash to equivalents, XXXX. the prepared and Under the address to XXXX we plan, our cash, investments with of questions. operating company and our cash current concludes expect happy $XXX.X ended we any and through we Finally, quarter million fund our would equivalents investments. remarks,

Operator

[Operator Raycroft comes first Maury Jefferies. question Instructions] Our with from

is line now Your open.

Maury Raycroft

is internationally? specifics particularly any on First if going you and X more it's wanted how how the going site that XXX topic on one with I just and first on to U.S. is activation in recruitment just Phase the COVID, is provide can ask for

Jim Cassella

Maury. Jim. Sure. is Hi, This

question. great So,

well. is We trial The are doing ongoing. very

sites very we are We on Canadian site. have brought and U.S. well the European our all and doing

learned their that year under these a now great experienced think running team I on COVID, we conditions. have had So is given the we last we a lot, experience trials

are study according plan. quarter. reminder, to as second to And just a Phase So are going think kicking I our we as be this off in things going planned X

Maury Raycroft

Got And just… it.

Roger Tung

This dropped sorry, call. is apologize, I Roger, the off I

Maury Raycroft

as follow-up, was what specifics started second as is you going mention guys the I'm Jim get Yes, comments enrolling just for activating just can X the sites any internationally. Phase patients X and you there that enrollment If there wondering guess first first strategy I that? for more how And that the on your for question is and one. on Phase is

Jim Cassella

a it's look, things we there space selected, nicely. progressing are very now. out very Yes, John, have our sites right And competitive

We have label our we because study activities on enrollment placebo-controlled that though an ongoing open-label have data will has and where our recruitment in we people active the good into study, they know also even very, that open trials to useful treatment. extension are that go which flip extension we have drives been very able patients

our facilitate really I we've our designs of to enrollment program trial in So optimized think the all program. into

we to going be any simultaneously, trials these believe is running issue. So don't

Maury Raycroft

to and question XX over strategy next runway a cash wanted ask months. the about also And financing to XX

potentially Just you milestone how wondering talk payments partners your a from like trial impact going scenarios could delay forward? could guys or decisions if about

Roger Tung

can you that? Marc, take

Marc Becker

Sure. Yes, thanks, Maury.

we've So Phase have kick capital X doubt look we now. so about bring second to we'll and We're off, are X, to a in got is a Phase There in need. late-stage company no capital.

do at always dilutive year of we and and this cash so non-dilutive end assessing we're the And have opportunities.

out We also ATM have an there.

as So we we're exploring those all speak. options

Maury Raycroft

the as the NDA And being and DDI support. normal that of last Xs part just are studies packaging quick the Phase conducted labeling alongside question on

comment can you wondering with Just the on those? if progress

Jim Cassella

Maury. Sure, Jim again.

those moving the in studies team things development be studies are there, to team those NDA, support will early going very clinical are that yes, are and our nicely. nicely a we very So progressing great have

number that NDA those a support we on will completed the We those to by track time have of have we're will and the all file.

Operator

next question comes from JMP Butler with Our Jason Securities.

Your open. line is now

Jason Butler

taking for the questions. thanks Hi,

Can trial, about Phase the quick about just the differences were X similar. and on then an you're a one, sites of that, second studies? in I talk start. us one And potentially the overlap First any enrollment just trial said you designs? the you remind can know you Roger between two they also, meaningful to

Roger Tung

the and Well, Thanks kick I'll very Jason. for much to over start Jim. questions, then it

same the for endpoints the So will two studies. the be

smaller have robust Europe The will also we enough patients - will you database, a it exposed to want further. and be safety quite more because the second more for who we'll And have been produce study. what there CTP-XXX do will in be sites will be be second comment to will to Jim believe one

Jim Cassella

meet have that I right. Yes, will criteria. that's enrollment mean basically we our picked centers

have the are in other study. of cases In we capable more one participating in centers high that just have responsible we enrolling centers So for cases, than some study. one

our So selecting I of being of geared run both centers that really is to think efficiently. process able towards part studies

taking to As we X run Roger opportunities the Phase second some trial. for said, centers are European more

this of on going is you at Europe in know, As time. a not lot there

there So there. of patients fresh lot is a

Jason Butler

me, us you And can review on XXX patent. helpful. update just second the then the question any Great, PTAB from of give

what then post a there mid-May I possible. think in that? was And you've still steps for be last a Thanks. said following is that quarter review the next that grant potential would

Roger Tung

petition petition and that. XXX is against there PTAB initial Sure, Insight forth had we responded and to back patent. so PGR it, been the additional have on filed that currently their They has reviewing filed the

should middle month. We the of review they this on whether decision a expect not PGR around that or initiate to have

that that So our that think Insight initiate We be strong it that if petition they really any initiation that even if so instituted. calendar by not we challenges. not do expectation and hope will our for conducted why But be survive of the will a is we is will the is, believe that review, the patent good is completed to argument decide valid, time. of that year it have arguments within it that's

Operator

question comes Berenberg. Hong from with Esther Our next

Your now line open. is

Esther Hong

me. from questions Two

separately any First results clinical Thanks. for the development in And other can areas? then therapeutic second CTP-XXX speak pipeline additional or on, you in treatments about can alopecia opportunities, competitor preclinical about you for speak areata. regarding

Roger Tung

on first to Esther, welcome follow-up crack wants Hi a that. take - Jim and so that his at if thoughts I'll

available SALT we've feel they while. currently earlier the clinical XXX's on with at that X But seen baricitinib robust entities, data and they indicates statistically are most that at data is X-milligram CTP-XXX, the X across actually both Phase for dose multiple Phase I those believe might ritlecitinib. a responses X-milligram have the associated that based more any we with there than are think have Lilly So data the The studies only has XX has year, and release results which significant been score. that strength. had for And the that baricitinib. data on that this month the baricitinib by at in we been this them released are recent data be The development

XX% the and response at the THRIVE-AAX XX specifically they those seeing in Lilly really weeks. what is XX% both between So and THRIVE-AAX level and weeks. contrast, the our And are between responses at indicated and X-milligram measured level. that XX% at been XX at are XX% In SALT response XX studies have X-milligram

respect to. earlier daily at doses, So it's saw XX-milligram and and responses significantly twice timeframe X-milligram and XX% we XX% our

leave So at just I'll it that.

are For awaiting Phase from we ritlecitinib, study. their X/X the readout

And have there appropriate an comparison so, don't we late-stage yet.

Esther Hong

additional just then beyond CTP-XXX And disorder? pipeline autoimmune opportunities of

Roger Tung

Right, additional with of to is expected so CTP-XXX active profile states beyond you a activity JAK alopecia disease [TIP] clearly areata, noted. and X/X as be of in X

focused really efforts of our alopecia areata. have on We the to-date treatment

this have at So share state disease time. to additional we don't information

bit We us have time. which indications here competitive not would spent for at a if talk short present indications, our a and forward, we're going reasons, XXX interest to for the go looking to of those be identified really about quite at of as time we list but follow-on very high of

Operator

[Operator Instructions] Securities. from with comes Difei Mizuho Yang Our question next

Your line is now open.

Difei Yang

versus of question JAK general, potential around space. differentiation Do safety think in a comment about could bit even wondering this these inhibitors how effect? between you think on among a class compounds recent general on a versus JAK the if in - in you the the in about developments safety the you CTP-XXX Just

Roger Tung

Hi Difei, question. thanks the for

now and it's individual one be as some inhibitors that JAK effects class small or with both dates have molecule differences to think are see trying that all, those inhibitors respect that think JAKs would differ compounds PDUFA the is information the to over over individual as related appear across that individual and that that inhibition information. of the now first be in clear assess the understand clarified effects We JAK to that data either class And to-date be approved are clearly get continue they We great to effects it been differences there respect future. that as different off FDA with in classes it's credit be additional of are that JAK's their our may expect numerous with half JAK I addressed indications inhibitors aspects. pushed and to assessed associated have the well and and specifics think there can target FDA larger time with clear couple there, year assesses of will relative we've terms there that effects so of a the to are a molecule-to-molecule. inhibitors utility that be and there course the seen a of with So in to JAKs from or becomes of multiple also course back, similarities used compounds are The relative probably will population. compounds, the will around FDA in its next, better

Our view be states efficacy compounds and that and FDA. where assessed this is will of case-by-case will addressed situation safety be a largely disease by in profiles individual the

instance, alopecia states for is mechanisms rheumatoid other of some One inflammatory of that the some or not of effective areata of are in is alopecia of the areata, are states facts they other of disease in action disease arthritis. treatment as

that And fairly aware inhibitors in limited. of greatest modalities. so, compounds be alopecia future that the for alopecia of will choices have be treatment JAK the efficacy areata I'm areata of effective foreseeable in will other the versus to-date shown the

And inhibitors. itself, of able And we've compound so, our skew the at before overall course it's been and discussed quite NDA as exposure we'll long-term benefit favorably will to with profile developing that expectation to of risk with that of database the to submission. with very respect for use the happy safety profile be substantial of safety the CTP-XXX the JAK FDA time we've XXX to provide a our are

Operator

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

Justine Koenigsberg

progress. you, We'd look this we joining us for Juan. to to keeping Thank like our everyone updated thank morning and forward on everybody

please of page upcoming website. conferences, the within our visit This Thank Investor events you. call. our For today's list concludes section the investor of

Operator

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

disconnect. You may now

Concert Pharmaceuticals (CNCE) 4 May 212021 Q1 Earnings call transcript