CNCE - Earnings call transcript Q2 2022 | Concert Pharmaceuticals Inc

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Operator

Good day, and thank you for standing by. Welcome to Concert Pharmaceuticals Second Quarter 2021 Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Justine Koenigsberg, Senior Vice President, Corporate Communications and Investor Relations.

You may begin.

Justine Koenigsberg

in to include Second recently a III for welcome Update, XXXX reported and results will which discussion CTP-XXX morning, Concert Quarter Pharmaceuticals Investor Phase Good areata. alopecia of our presentation, website. top the the available corporate found data Details which of of be our line can section in are our slide IR in

will Chief CEO; Becker, Chief Officer, Financial Joining me remarks the prepared Chief Marc with join and are Roger Cassella, Nancy Q&A. and Stuart, Operating for this morning Tung, Officer; Jim President and team Officer. Development

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

Roger Tung

Justine, and today's everyone, for thank joining update. us for you, you, Thank

this related earlier of second high top impressive III treatment led similarly study, areata. reported key the extremely line and to produced in THRIVE-AAX efficacy of from level We're rapid alopecia week, observed underscoring pleased line several During alopecia the confirming our the in our released with that moderate-to-severe the results CTP-XXX data by positive we program top developments CTP-XXX Phase quarter, areata, outstanding THRIVE-AAX study.

we're application to and review FDA, the and is with nonclinical planned half filing to a is team data, consolidate fully further drug XXXX. Our our of at the first for which new pace clinical advancing and moving

that alopecia population to a before patients opportunity unmet with CTP-XXX be that will an see We me areata. address of for large, well we market underserved positioned us. envision the important describe Let need

XX patient positive primary believe With potential. subset years on included daily XX% positive determine THRIVE-AA old, a represents amount the score registration need to measure now companies with while hundreds of hair of opportunity to CTP-XXX profile patients sizable than A to the believe approximately extent a tool, score U.S. a severity to to blockbuster XXX which seen assessments, less score, from the SALT In of highly to strong endpoint ranges has of total X we consistent patients results THRIVE-AAX first of product lack XXX. statistical significant which the III at higher have the of having potentially placebo both loss, treatments a daily thousands scalp. on were satisfaction the groups of clinical we areata. to disease. endpoints there patient dose The THRIVE-AA top hair a And develop studies, multiple moderate-to-severe Based one line up we've to market we XX trial. from coverage SALT after of placebo no and with the corresponds for secondary alopecia to SALT, that the in Given scalp and loss. has results evaluating achieving competitive in placebo. to a X groups the III to Phase X.X an levels million XX groundbreaking twice profile. Canada to that contribute We we or is for the less of study, randomized, key corresponds CTP-XXX, the p-value hand, twice absolute week the to percentage current Both of placebo is XX clinically and the we consistent one Both met CTP-XXX and it hair These treatment regions what or as meaningful double-blinded, result. and clinical date treatment, believe included weeks scalp see the as that X equal hair by multicenter studies compared demonstrated we of closer of XX of and primary for trials and the X safety in doses met of alopecia XXX trials the X.XXXX. or treatment we're efficacy the the Each XX X SALT assessing and III hope from The scalp aged adults, milligrams both U.S., in at will scalp total greater saw X of data milligrams THRIVE-AAX with of early dose were in their both endpoint our weeks. in CTP-XXX, best-in-class secondary twice than in conducted confirmatory had statistically difference study statistically be treatment XX-milligram scalp Phase daily of hair to compared compared placebo-controlled, step with regrowth Europe. who weeks. the both hair have for significance were patients. XX providing versus all both Phase X-milligram of a also XX trials endpoints doses. weeks Similarly, are significantly THRIVE-AAX, key score

XX-milligram significance endpoint the groups had p-value dose X- of this The placebo. statistical we of CTP-XXX placebo study scalp in As for X.XXXX. at the groups dose regrowth week, weeks less earlier and met for both THRIVE-AAX relative a primary versus and twice-daily treatment XX both the to than difference hair announced

condition. well a believe patient statistically treatment significant we attaining indication. believe SALT be weeks CTP-XXX. highly that continue safety and is misunderstood proud of a areata satisfaction alopecia areata and we Additionally, we of placebo Many for patients secondary well the to continue not results to alopecia with And for in Treatment tolerated to great on better to for we XX inconsequential that lives. with the or that moderate-to-severe the early grow causes CTP-XXX effect both disease rapid cusp change in key are it. of We're hope that be part continues from and ability of for for differences live their disease as a effective serious CTP-XXX treatments THRIVE-AAX be as at consequences, impacting THRIVE-AAX, potential pleased statistically of the with and again best-in-class become their and prime see onset truly doses alopecia our lives. adults to placebo autoimmune it's generally in alopecia the Based regard And cosmetic broadly to suited XX trials as relative dosing. its with starting Concert their to to the to areata we both an was into severe available, showed and many profile impacted the people, With community, with is demonstrating treatment proposed recognized of on end areata. negatively just has significant to points, awareness

and me pause our the of Let financial an to discussion Marc, here turn who results. provide will overview

Marc Becker

you, Thank Roger.

our of quarter million financial As Research in of and results, reference tables XXXX. quarter quarter I million to please during were the compared found financial the today's second development the $XX.X $XX.X during XXXX XXXX second review second expenses press release.

the expenses the were American We million general The during open-label continue until to reminder, studies the study during North extension $X.X extension the expected and as to a and compared costs second is with continue approval. a clinical associated administrative in to decrease of for administrative primarily CTP-XXX, stock-based to have expenses XXXX of million $X.X quarter decreased compensation. second XXXX. and noncash quarter General relates

the cash investments. proceeds in includes to in our was of of we stockholders million to applicable This per for We of will the period gross X common XXXX. loss $XXX.X the through XXXX financing. and runway of exercise received to of follow-on and XXXX stockholders in million. partial XXXX. common XXXX ended warrant that Capital shoe. with received million XXXX RA BVF compared before received equivalents exercise through proceeds the and portion quarter $XX.X included The share the June share per in The quarter income $X.X underwriting cash into a the expenses, with full of for $XX.X the proceeds million equity issued expect the follow-on net the exercise applicable or November of by a $XX discounts the Together, the which gross quarter net offering these totaled totaled second second offering second connection of same our of equity or extend $X.XX through $XX.X Our operating million $X.XX combination million transactions and warrants cash, green a

areata two additional behind have market optimistic issued we that connection all CTP-XXX. financing. potential us, CTP-XXX, around an of half future XXXX, lives the with November XXXX about III to address a is We'd to remaining Alopecia we to millions be are a outstanding receive have positive of the our and exercise to the for the questions. opportunity With the these Phase $XX look million We large and in the warrants submission We affects in the happy readouts underserved we in prepared planned forward that NDA concludes With patients. first this patients of positive remarks. of ability our make our impact world. upon major any

Operator

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

Your line now open. is

Jason Butler

the you're interactions? First, also a including give product? the bit plans and between now advancing to color can to little I be needs work on to regulatory done that you commercialize for maybe submitting your then just ask more how NDA And

James Cassella

is Thanks the first for Jim. part. this Jason, the answer I'll question.

things We'll III positive have reports data behind progressing. trials us. finalizing have in. So We Obviously, top be for THRIVE-AAX, both out our Phase THRIVE-AAX. line just THRIVE-AAX. to data of clinical both coming we study are It's our for more the great reported

a study, and Phase from as being wrap II have over labeling out know, THRIVE-AAX have purposes, on a planned. or as to part for filing. we've as and data be we'll are some those rolled continuing the up Phase are study is studies front, II NDA you and report we they're other completed, extension well studies that of track supportive the world. And to I as open-label conducting the to subjects support are mostly Also able the the as clinical These THRIVE-AAX, on been in conducted subjects. in Phase durability the We

over. be Our the II NDA that and intent Phase in subjects rolled database is that have to have a Phase safety comprised to large will of report III the our

there. number Our in large patients goal of is have to a

in NDA time of enroll more cut they as and to provide drug, continue those gain in subjects well. we those as on a data there we'll So have and the

things, So to things clinical all nicely and first the the year. are of on track next of on really half we're very in side progressing file

Nancy Stuart

I'll question. commercial Nancy. your answer it's Jason,

advocacy to ensure to planning work, evidence medical adopter And ensure launch. are actively patient activities mapping, a We the early few. commercial the laying to doing access, we're like just these market groundwork readiness, the and payer name communications, things and patient successful prefer to appropriate understanding include journey, KOL

Jason Butler

that and Great. -- like, -- one that Can follow-up quick terms extension study, Jim. And in just of for retention transfer we what's just -- patients then been enrolled have in what's the earlier and for the THRIVE-AAX the several the you really been just would have been high but patient in Obviously, a rate enrollment persistence like? from rate AAX, or there months?

James Cassella

Yes.

Jason, question. So a it's great

very we you had enrollment have As rate. high note,

of greater for example, did subjects has XX% For than ongoing study roll a with been over, to were over. had who roll eligible THRIVE-AAX, THRIVE-AAX, The we've while. the

a patients over on a And large high. have rate, for that we number X obviously, of been for patients of as count on retention have the We but you patients on been have I number had years. over drug for for exact it's years an number two large very for drug year. backwards, don't been a and we've have

the this in it's sorry, the in. motivation showing -- roll the have would don't the because now that trial daily very, say changes to as but high something trial clearly is stay in exact changes of And it -- the I'm I very number it So and numbers. subjects is we I patients the number

Operator

Lee our comes next question Joon And Truist. from from

Your line is now open.

Leszek Sulewski

This is Congrats June. Les for on the data. on

treatment-related the nitpick, in SAE each was look but start nature data trial? not one of I'll was of maybe to the possibly there. what that through the kind to and Just

James Cassella

effects had in a was Sure, There fever were investigator we were the prudent was did investigator number Yes, to THRIVE-AAX, the related could possible possibly with extenuating associated of immunity. circumstances on THRIVE-AAX, had dose reported the SAEs That who we and with subject In had call individual JAK but not SAE. the the determined that X, did it that subject we inhibitors trial. Les. be have of this possibly possibly pneumonia somebody flu because and of But possibly meningitis. we thought Of those related X BID some to group. in each related. related Most X-milligram and this had treatment. the related and thought their possible there, have of who individual an be to so SAEs a in X was study judgment

think So those SAEs. are X related are possibly those the I well, had the cases -- we where

said, were there that related I trial determined were As in to to study not other be SAEs each treatment.

Leszek Sulewski

is at think absolute less, SALT XX AAX? the you Got achieving helpful. was of separation why then comment XX-milligram it. or your when you THRIVE-AAX versus at dose That can was placebo the dose higher versus -- study looking And higher in on score

James Cassella

think there's I of points couple difference a between those.

There few clearly of each it's are within the range other. apart. think I a points

These we studies. have for the data BID. findings the that X- the consistent and XX-milligram important level with we of X-milligram dose between a that have dose show findings the as XX-milligram with think both is high very the efficacy both I about the thing

these have at think highest the numbers out I there reported been literature. the to be are that looking

So of range definitely they're I each think within other.

I is very think good THRIVE-AAX confirmatory study. a

major I efficacy. they think So X as do I other support wouldn't findings a a difference that level say the dose, high for XX-milligram between of the but each there's

Roger Tung

also through frame. note continuing time trajectory the is that XX-, XX-week upwards I'll XX-, move of response Well, to the

point efficacy XX-week As significant to Jim to beyond extent. time that continues the previously has reported rise a

endpoint. what XXX a patient be we efficacy to of little of continues particular point. estimated be at that kinetic that clearly is the by think you where I So that is think is of phenomenon than at may that a XX-week bit group just greater looking But

Leszek Sulewski

is heading into what strategy then And NDA the it. dose your Got for selection filing?

James Cassella

Yes.

from X not another plan was and because out investigate ruled trial, has dose beginning as both that and doses, in dose-ranging group Phase the the effective determined were Our to been the II X-milligram that our we XX-milligram dose we effective. those

along best patients dose having X to doses the based patients on a has all the to for KOLs with conversations physicians in been strategy for Our available the program early and provide lot flexibility of thought that who choose for would subject.

plan Our to doses. both file is

believe We for for conversation the to a as efficacy benefit a be. both the that recommended data we both than generally a is is lot dose will X. but higher one will has results starting then of than have clearly the X. the It high shows that make good do with but what dose determination good and performing That XX-milligram the and group shown to consistently FDA, patients, be better

will So obviously, our those recommendation would be to start with the conversations. XX, but have we

Our plan is both. to file

Leszek Sulewski

Okay.

may. Just last I one, if

mention NDA extension to going filing. you're did you open-label You with will Street with that as -- prior share to submission? the study along Was that well to with something present the

James Cassella

Yes.

extension over focusing Les, Phase have the So, I open-label and obviously, on III mean, rolling been been program patients into the study. we've

We be more will extension a to of future analysis open-label meeting. need to is do plan the and presenting formal data at some our those data,

Operator

from question Jefferies. comes Raycroft Maury Our next from

open. now is line Your

Kevin Strang

Congrats Maury. for on on again data. Kevin is This the great

are even for to thinking ex X line time there? look IIIs are U.S. derisking what U.S.? what partnering ask the how about wanted in hand, some Phase or the you like scenarios with And Just could

Roger Tung

the question, Kevin. Thanks for

We are, with pleased very now. have in fact, us that data to

As we is commercialize intent in said our ourselves the before, to U.S.

We've forward position first indicated, that's out a ourselves. the is is doing partnering to III a continuing think that released. partnership, make to good that to as interest safe us but data necessary ruled asset development business now been as So I our the say to don't it's to sense. in is work And second intent move would as the ex concerned, specifics, We discuss far that accrete U.S. move Phase Nancy never there's commercialize. U.S. but has in we're

Kevin Strang

forward. on And just a going Great. then Okay. follow-up IP

So are filing could lay you likely into out you just think launch? think you scenarios scenarios are what as possible and move what and you

Roger Tung

patent, method CTP-XXX. to respect confirmation be with on continuing matter to there the valid of composition be which our listable the an will it continue strong that dosing know, believe had the of continue There's valid. for another which approval to which why is we potential will we is Orange you Book of of extension own and as Well, -- use patents, patent of from valid, are our PTAB validity XXXX, we're that on should work and year, possibly to valid to be and of we patent, and out which reasons

So that's along. playing out as go we

Operator

Koenigsberg I am I over to remarks. turn And Justine no the for showing would further questions. back like call to closing

Justine Koenigsberg

this This us for call. If Thank Justin. Thank you questions, out. you. don't there reach Thank are you, today's to please any hesitate concludes joining morning. follow-up

Operator

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

disconnect. now may You

Concert Pharmaceuticals (CNCE) 6 Aug 222022 Q2 Earnings call transcript