CNCE - Earnings call transcript Q3 2021 | Concert Pharmaceuticals Inc

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Operator

Good morning, and welcome to Concert Pharmaceuticals Third Quarter 2021 Investor Update.

Joining me this morning with prepared remarks are Roger Tung, our CEO; and Marc Becker, our CFO.

Our prepared comments today will be brief so we can jump right into the Q&A portion of the call.

We will then be joined by Nancy Stuart, our Chief Operating Officer; and Jim Cassella, our Chief Development Officer.

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

Roger Tung

nearly team pivotal was all continues programs help important enroll our all XXXX undertaking last Justin. path, time trial execution to the of THRIVE-AAX you, manage successive to lines. about a I'm milestone patients advance dealing with is we more with This the in the has in each been to been projected our alopecia of has CTP-XXX large this bring that for sites, new trial our job XX commercialization. Thank trial the areata. outstanding agent line pandemic. all announced XXX enrolled. to involving With CTP-XXX Along doing fully that proud of this month to team than an international our this

FDA enrollment early pivotal of our the remain we track XXXX. file past our NDA with trial, to CTP-XXX Looking on first in

in line top second continue to expected the results trials Phase half X year. from We expect of The expected the the results AAX second are THRIVE results both in next XXXX. are AAX THRIVE quarter and

with compiled well the has field, Based results be we've JAK potential XXX XXX, data other best-in-class top therapies, to potential we to on compounds inflammatory responsive action on line in of the so outside me of autoimmune with the Let currently Unlike data date for has to continue to date to CTP-XXX's landscape. that developed for with in releases developed inhibition. XXX. We're diseases areata poorly back believe a perspective some excited the as approved being we've mechanisms just as therapeutic proven the very compound. about step alopecia far other

the American quarter, we the opportunity summit. JAK had XXX findings North extension to open-label the development past second present ongoing drug During study, from our inhibitors

As XXX for year least this dosed half. and presentation had been a over patients summarized, with XXX at a

high a to in to study. participate extension the have patients continue eligible elected percentage Importantly, of

on we in CTP-XXX continues with show study. who findings the well those areata on CTP-XXX patients adverse we execution up, in with score soon we as presented were focused The steadfast As advantaged we pivotal believe competitively we be and studies. bring the reported the SALT treatment patients sum of majority remain generally study to consistent Phase to clinical the to regrowth hope of alopecia our all, our data areata and alopecia CTP-XXX vast alopecia treating possible. the next areata. have or assessing Above for events To improved program track X as readouts in tolerated maintained hair checking for into with continued that year,

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

Marc Becker

Thank you, Roger.

$XX.X higher The million was $X.X increase please the our found same were ongoing QX financial press release. to program. and for XXXX. expense in compared million in X during I primarily service CTP-XXX compared was the General administrative QX development based stock and the external attributable were to related Phase to quarter 'XX tables The $XX.X and primarily $X.X As non-cash Research 'XX third professional clinical expenses reference the during today's to 'XX in period million same compensation. results, the million quarter increase of XXXX. review third during XXXX period expenses financial

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

and we say of licensing financing with sale agreement cash and and warrants, Capital XXXX ended components, with million preferred Avanir. quarter three happy third an equivalents, portion future existing million. BVF financing of we the consists with RA $XXX.X cash to This whereby in we last a the and stock, royalties our I'm completed potential $XX additional week a AVP-XXX raised common of While under of very

We will upon full warrants have additional the the in exercise to the potential an of $XXX.X receive issued with connection million agreement.

As will This XXXX. to drug anticipated X exercised, our to key quarter of funded expect CTP-XXX, and the the us for If the mentioned focus. beyond in plan, financial Phase be warrants operating pipeline into under all company fully to cash a which result, strength of allow continue the submission of new we we advancing current fund our expect equivalents Roger added XXXX. application our CTP-XXX fourth expected our early as the cash is are program,

clinical As Roger several the year two Concert to for call, at start us. for milestones the the mentioned CTP-XXX has of trials. alopecia setting achieved stage be key XXXX important an is in areata advancing late stage for

ongoing readouts our a next of our treatment be would happy we us to The hope and any optimistic as prepared We best-in-class the opportunity the remarks potential This studies makes bring execution both to program expect market. CTP-XXX from year. have for to we data future, address questions. clinical to concludes

Operator

Our [Operator from comes Instructions] Securities. from question Jason first JMP Butler

open. Your line is now

Jason Butler

first the guess CTP-XXX. on one I

U.S. development for beyond just you're on thinking further how financing. if that Thanks. what the development including And the are or curious curious of congrats XXX We're with changed XXX? drug? it's Just even recent on the about the plans then ex pipeline

Roger Tung

question, much for Mr. the is Hi, thanks very Roger. this

scattered sites well as time the do have include do work Canada. develop that that waiting clinical we're X the, development something specific to the trial are of focus is sense registration really in this U.S. ex on first. as not ex in we that So Europe on, on studies going Phase throughout for the in plans trial at or U.S. or registration have We that's U.S.

well through pipeline indications XXX in As far we for be is and XXX ex compounds. we expansion as additional as are additional development interested XXX additional for to continue for both concerned, as

are on X foremost for we and say and Phase studies since subsequently. first currently have remains Areata we'll it into more Alopecia focus Our

Operator

Thank from question next Truist you. with Securities. Lee] And our comes [Joon

open. now is line Your

Unidentified Analyst

morning. a broaden is could financing. enhance AA for And your clinical or Alopecia scale. and on any opportunity a good just taking and the your to provide I you severity from any for were the call compared June what the into Les and on additional SALT ongoing how practice? and there the expect implemented its SALT And and to involvement and scale Areata thanks market regarding disease I does questions be Yes, Also, impact you lastly, in Can for for approach this few on this more could the do this findings have new trials the your development a congratulations scores on again, color filing? replacement NDA potentially have participation that new follow-up? be

Jim Cassella

this Hi, is Jim.

is forward. So areata to as really This severity Care by to was important entire you start sure this scores is consideration far make wanted step when taken it. as that initiated Well’s, that scale think an go, alopecia into assigning we the who the that

referred So terms of in the included, included, on based and so on the on body and past, it’s loss universalis hair been the of scalp, universalis the complete totalis baldness to your the hair on body. alopecia mostly scalp amount

being. and notion that there really the that the trying And new highlight industry severity. importance areata paper in driven at I to think alopecia when affects other of KOL both, it whole the factors was look with - involvement the includes you're to was

And scalp So your But there the the not to takes hair loss, measurement whether this assess like won't, things be it there's about will amount replace to a emotional into or but account, this or loss. other address more other you psychological that burdens SALT No, on amount of take will hair amount or it tool question include their allows will loss, it's this and is going like of SALT? scale that. psychological also account and factors new impact factors, whether other factors, not flexible the into are come because that but of into whether play. to

yes. that's on scale So that

Unidentified Analyst

expansion XXX to that. Xnd labeling this box take what Very any is helpful, JAK potential of premature second thank CTP time? or breakthrough see Do you. for discuss the warnings Inhibitors? you see at for is your on you Thank then part, it to FDA’s And

Jim Cassella

FDA the in knowledge the a division. on base inhibitors, building especially JAK think dermatology is I

with indications. So therapeutic the effects out come that labeling they've in I think arthritis, that clearly with terms rheumatoid of

the submitted as dermatology atopic the they're division, far I approval for read still on As been no determinations on have think, drugs there's that those yet. and dermatitis,

are early point. know there's to be So things I where in But be it exactly labeling might at expect in I think, the little this of we kind space some going space. going think to a some too may

approved alopecia alopecia treatment especially for the think that to I consider, there no our areata in is important is areata. drug point for

are is and in treatment. patho-physiology, the other very it's very there other lot for inhibition areata. there's dermatitis, important or are drugs therapeutic no seems in existing important of arthritis it's a a JAK outside is that these the or treatment, class atopic very JAK a So indications. And unlike rheumatoid class. effective alopecia mechanism especially really, be for indications, to a JAK involved approved effective it where

makes really of treatment very areata? JAK And really alopecia important different. here it is alopecia areata, for So to I stay think and

Unidentified Analyst

question. If progress formulation? I belief provide modified Thank Can more you. may, the one on update you a maybe

Roger Tung

Sure, us. it's an ongoing project for

terms we of for don't work really to available publicly are information is say point project fair time, at progress. think in us we have continuing. anything in it's I and but have, report important an that it making this to And we

Operator

you. Thank

Maury Our from with next question comes Jefferies. Raycroft

is Your line open.

Maury Raycroft

KOL’s questions talk patient any from X in compares the kind X? from based to enrolling higher of of of Phase congrats on the can my one you some your morning, the population I are patients. specifics if good and guess, Phase FDA. prior X and about updates just And Hi, demand it’s the and Phase for there your commentary follow-up maybe you on from degree thanks enthusiasm can taking for to program the questions provide of

James McCabe

Maury Yes is Jim thanks, again. hey, this

enthusiasm very have inhibition I So just previously, areata. for mentioned a important for a mechanism JAK Yes, of think we I alopecia program. as our lot is

sites with KOL’s X all and many, many working our Roger as mentioned, are program. Phase of We for the

I in X in done, of program. well, a Phase clinical recruiting the really for constrained think any for have trial, COVID We very type environment

trial. We of looking lot have in the patients a into to enthusiastic get

very I very, So well. that's all think gone

a data the hear our we on think results. enthusiasm, is we that that believe Phase set based X of lot very I strong So

criteria. our X same trials, the have data safety as NDA. entry numbers very make we bring were kind of the our to we really sure a submit population have We to Phase up similar The to Phase Xs to have sufficient expanded

hair scalp coming type course, X. which Phase SALT the the of have the for did tool we for Phase into same assessing score, And as entry criteria using trial loss. the We of X we're is

a we studies, But the used in for for a our now our good were using calculations results. you to able XX the X. up SALT able we're three program Phase which we were And Phase calculate, know, for Now we end for X, Phase of we X point. Phase numeric different on so X have to our power X again, our trial, ran remember, score, achievement calculation we Phase our Phase based X power basis forming the

X patient population between come we in same Phase same the X population. Phase it the a patient drug the and have we for program X very the have and So studies. understanding of we the confident Phase population for good that what our base And is into does

Maury Raycroft

anything is X the and Phase study say at point dose point? adjustments at including And blinded. safety status But the general this this can you of balancing down about

James McCabe

the that can actually XXX I patients in tell study of released double-blind THRIVE-AAX that enrolled What is that studies. these we our enrollment the we've information are controlled placebo Obviously our you finished study.

We groups have and the BID placebo. X mg the XX mg compared to BID dose

we're greater We the placebo, turned as recruitment we've percentage open extension rolling very had be a rolling reminder, positive patients we today to label than treatment proportion good high a into very out But a X, findings over. in randomizing active are we tool. Phase a also And over to on of our which study. had also subjects have has based to randomizing

were data X Phase safety generating, We patients, long-term that for a - that of the with mentioned open Roger to I that half a started that of presented, continued data at we of lot the in patients do conference. earlier highlight in number very study, our in first think we this that year, study we the April extension we XXX been we've So trial. time presented at JAK XXXX as and a fair a label at drug have did conference that the over on year have

So on the think, consistent NDA. in progress database X. safety And label in continuing saw we have our generating ends safety compared I what Phase think the profile a I open to the up being for we

Maury Raycroft

a if wanted And maybe are royalties tied just had Concert? Avanir you the the to question by financing, are rest wholly just $XXX of royalties way, last additional those or rest any of from the recent me, your to million check owned in

Marc Becker

this Marc. royalties those The concert. owned is by Maury rest are of wholly

the the only $XXX into for million, exercised? remaining have not warrants million where the factored the still we fully So the is and royalty, the $XXX in case are that's

Operator

with Thank question Berenberg. next you. Hong our from And comes Esther

Your is open. line

Elaine Kim

in XXXX. This in negative trials I what's ask just HX of Esther. that is for AVP-XXX completion Alzheimer's know Kim and symptoms the it's is agitation currently to Elaine I of want schizophrenia expecting status trial several including

some Thank other know Just wanted any updates are color? added if to you. there

Roger Tung

for it’s This as we'll there this you very agitation in is much question. Phase or projected any X There studies scheduled X Alzheimer's really time, out half year further to that read thanks XXXX. is information latter - study. Phase next the read is of negative note, out study we that be the also At have other out are symptoms two reading the X are Roger, Phase a study, the and to don't which

they to relations. continues compound. prominently heavily the And invest in investor Avanir their So, in very highlighted

further So that available. have we it's publicly about, are beyond but something what's they excited no information

Operator

comes [Operator Lim Instructions] question Alex And next with our from Mizuho.

open. is line Your

Alex Lim

taking for Thanks question. the

prioritize due entities? molecular indications future about pipeline for or Just would prioritize CTP-XXX new you new thinking opportunities

Roger Tung

compound is well. it's this it development the our registration and and amount a in involved have of forward have investment the great - indication And at It's high question, think moving I additional with of made XXX, to actively we given Roger. we're interests in something stage Hi, registration. towards compounds. the earlier also look that feeling we've an enthusiasm it, as of in But to likelihood we for

me other. for to it's So over hard the rank one

I excited think about both. we're

Operator

Thank I'd to time, back conference And any comments. hand for questions. Justin this at the you. showing I'm the up to like Koenigsberg, for closing over

Justine Koenigsberg

our look everyone you. joining thank updates Thank to this We'd and morning on progress. to to provide us forward continuing for like we

at Thank As This questions, a reminder, Conference. any week the will we are don't reach of out. Jeffrey's concludes London be today's follow-up to participating there if please next call. you. course And hesitate

Operator

for disconnect concludes a call. you. This participation, have conference your now Thank wonderful today's you Thank you everyone may day.

Concert Pharmaceuticals (CNCE) 9 Nov 212021 Q3 Earnings call transcript