CNCE - Earnings call transcript Q3 2018 | Concert Pharmaceuticals Inc

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Operator

Good morning, ladies and gentlemen, and welcome to the Concert Pharmaceuticals Third Quarter 2018 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Justine Koenigsberg.

You may go ahead.

Justine Koenigsberg

Julie. you, Thank welcome Update. and Pharmaceuticals Quarter Third Good to Investor XXXX morning, Concert

Our was release financial morning, our concertpharma.com. press announcing release results on website electronic of available and copy issued our also press is our at an this earlier

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

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

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

Roger Tung

you, Thank morning. and Justine, good

ongoing We committed with of In treatment data developing we to market. During dose-ranging to We're our for the significantly clinic. focused patients of highly our report weeks, this candidate remain a we're progress in alopecia on an severe we alopecia address CTP-XXX to first-in-class will the developing forefront unmet pleased as coming trial. efficacy lead drug an made a advancing need pipeline from and third oral CTP-XXX the for at major promising CTP-XXX, in areata, in the the clinical areata. product, the we've advancing quarter, development moderate treatment with

have for CTP-XXX program clinical to great Our momentum. continues

trial. an and, supported the assessed quarter, data BID third cohort addition the of safety XX-week full the cohort the of to importantly, X-milligram XX-milligram BID committee a data monitoring During independent

important higher-dose future in in began As our amended enrolling our in a for and, we the relationship previously trials. XX-milligram cohort. dose-response that informed dose best of defining the the with plans, evaluation We CTP-XXX protocol the September, the result, for is consistent selection enabling dose believe patients announced for

active As mechanism X- the dose data cohorts the pharmacologically range. top we later of compound, in X-milligram profile trial CTP-XXX and unblind the line cohort mechanistic on suited from treatment the double-blinded Phase areata. CTP-XXX this progresses, we be within and the data our report will well Based and The this and final that is potentially understanding will alopecia the believe of very of month. results pharmacokinetic for this IIa

mechanism We as has or combined with its that has alopecia efficacy inhibitors. relative for demonstrated Specifically, principle JAK JAK X/X its what may been believe for of proof offer efficacy. selectivity subtype of see JAK patients advantages to demonstrated areata properties, the other -- safety CTP-XXX, pharmacokinetic important we

have our a we confident final defend brought held and by Before In brief X, be make of is remain decision that XXXX, We will January a to render patent comment arguments let PTAB patent. we on the Incyte ability on validity to April that against the our oral front. in XX, XXXX. other turn highlights legal expected the to IPR me proceeding in the covering pipeline, the CTP-XXX, our

we believe development. its we addition, aggressively to to In and advancing have continue ways protect CTP-XXX multiple intend

form very addition as about the a which excited that a In XXX D-serine, acid neurotransmitter for is receptor. an our enthusiasm also co-agonist of NMDA endogenous deuterated CTP-XXX. to is acts at amino CTP-XXX, we're

healthy provide Concert's I in also applied has crossover D-serine. CTP-XXX We volunteers which with be these medication. applying Key quarter. toxicity, to patients. horizon, benefit this of therapeutic has our third here to hope species. In we chemistry of Phase both our in progress. for alopecia of enhance readouts call forward on of and CTP-XXX innovative CTP-XXX Toxicology taking far will what ask hypofunction doses building the above more Marc to are We Phase single by results ascending not limited program pipeline to create include address to look an Unlike in support our D-serine move when I properties The financial will enthusiastic multiple medicines intend Phase candidates, development and and to and program proprietary comparison, chemistry a NMDA towards moving The previously, D-serine have believed potential Despite a the the pathophysiology therapeutic urea we about we finding deuterium updated example into review These standard-of-care evaluate with summary, and D-serine, individuals CTP-XXX. of Meeting. first-in-class cause will abnormal CTP-XXX supported clinical properties. schizophrenia creatinine intend single shown been at the safety American poster potential, you III-enabling preclinical dosed This clinic is concerns, programs efficacy since with Annual schizophrenia. which renal innovative schizophrenia. I'd its potential initiate to the levels It represents than is our to dose-ranging cause presented described another studies before to contribute unmet in like D-serine antipsychotic of which by receptor year-end that's next as of has to which the for we've adjunctive to clinical how particular, the Phase therapeutic to questions. safety medicine provided Oral in observed the and designed the a to I'm been our of The As technology to II we did profile potential administration toxic. shown been overly an week XXX for schizophrenia, needs D-serine published CTP-XXX preclinical with I as is in the be keeping by trial both where D-serine, Phase pause of to improve known doses We're is nephrotoxicity upon XXXX. have areata CTP-XXX quarter findings open program to in higher will many the treatment analyst on those CTP-XXX at serum D-serine. we're College potential of the similar studies. was nitrogen, even about CTP-XXX or levels even of deuterium of create opportunity for remarkable excited of blood significant exposure differentiated testing

Marc Becker

Thank you, Roger.

September the September XXXX, associated General XXXX. XXXX, the CTP-XXX $X.X press In the As financial were development and primarily $X.X were quarter and results, the were and the period development research development expenses found for expenses in of million our in million of million XXXX ended today's for please XXXX, to million. compared quarter third an in $XX release. ended administrative with I reference million to review third compared quarter same increase period, tables $X.X for XX, the the Research expenses and XX, $X.X of quarter CTP-XXX.

per XXXX close asset Our primarily net loss net Vertex. driven the agreement million $XX.X $XXX.X share million with net of to share of $X.XX by XX, for per or compared was income quarter with purchase the the or $X.XX related income CTP-XXX XXXX. The was revenue September a ended

equivalents third the cash ended and Finally, with cash, investments. million quarter of $XXX.X in we XXXX

time our that our programs be at XXXX value plan. cash current an to position exciting development fund closer Concert drivers anticipate key and continue for We're company We to will operating sufficient advance milestone to our as under events. other the into

the to Phase both to and the have registration. Vertex with anticipated for our collaboration milestone on line MDA. Alzheimer's meaningful CTP-XXX upside to under projecting initiation addition The with milestone Avanir and under to I the and them trials top complete for III of filings, CTP-XXX, million in include with support In U.S. agreement a AVP-XXX data a the agitation Avanir, collaboration financial to next acceptance generate payment the potential of Avanir to progressing Concert our The acceptance regulatory for of XXXX $X Phase which are our is our use Concert. deal to relate

receive first also of happy advance in alopecia we key under any commercial starting concludes to milestones for questions. readout we're pipeline to CTP-XXX With to backdrop, November. address with that and We remarks, prepared collaboration. our would our well positioned our stand This that areata be

Operator

[Operator Instructions].

from comes Stifel. Walsh from of question line first Your Adam the

Neil Carnahan

Neil we can when us XX-milligram on then update an progress readout? and of Adam. offer the that can for on enrollment the give on is you expect Can you maybe This any color

James Cassella

This is Jim.

at in, are So that that going you in is won't reference, in. as it the have of end weeks the until we starts get we at complete. and -- the and things months. complete. know, cohorts tell the ticking, able we up that cohort the enrollment specifics But And we X-milligram the the report we've you started enrollment for is intention all comes be XX-milligram the to we once September, the -- we'll XX dosing. the enrollment And once about of as X- will clock how just out X the of and know enrolled the is X, period, that really, when of give then data of end be our wrapping we enrollment But study we'll

Operator

Yang next Securities. Your line from of from Mizuho Difei the comes question

Difei Yang

couple a Just here.

trial, trials? a we before talk the the cetera? et regulatory do mg X pathway you dose little have you the to trials, how on wait could out? it CTP-XXX, readout Is on into you X works until about see First, need registrational And bit XX do moving

Roger Tung

thanks necessary feel provide meeting. for an question. II studies the move that the regulatory meet ranging until will end-of-Phase to pathway said Well, forward. with that, Yes. Having very that's hopeful know truly FDA won't ongoing the We dose in the we we

it that a XX-milligram assess to be then of efficacy, safety this forward. the we that enable path on directly And the really first with of meaningful into think group and X-milligram afterwards. studies the X- will available to necessary quality, of to both when dose to the that, so we But approach intend is moving cohorts, course, our all discussion FDA would pivotal if and and cohort, month, intent have will information sufficient later is us And possibly agency is regarding be data, from completed. the which

plan Phase way current really, is do the in single that studies, rather study. Our logistical running III more running X of studies toward very a aspects large than to

Difei Yang

if IP there I to protection very correctly. conference than on different heard made process level, the high the and asset. clarify IPR the to the additional call, a ways? that us in give could little you ways what about more earlier can are talked And yes, you color. believe just protect CTP-XXX, maybe Okay. use if And comment you the the other -- correct you are I On you wanted if bit

Roger Tung

of use believe approved. also that have have various with And filed drug we regulatory course, But that, prevail the of Sure. of we'll of the we we composition exclusivity that the will and covering have likelihood additional once Well, where beyond course, been know we, -- CTP-XXX. challenge. the IPR is patents ongoing have of have we aspects we

Operator

question next from the of Konstantinos Securities. Aprilakis JMP from comes line Your

Konstantinos Aprilakis

So first, selection a and strategy you forward us for can you biomarkers on what intent got depending I've the CTP-XXX, tracking you're ongoing pursuing in studies learned a whether Phase on And pivotal you're quick IIa maybe one study going XXX. into what there? remind on

Roger Tung

question. the for thanks Well, Sure.

having are be if it looking the biomarkers patients mechanism. be responsive using majority approach selection as mechanism the And being suggests may without really So JAK data as develop a ruxolitinib would we more the not diagnostic. to see for that that compound companion straightforward stalking case, strategy. at the that X/X to a horse we The of

our that's intent. not So

We're biopsies of do what mechanistically selection it the We detail And in understanding taking the number the purposes of a future. fine some this rather intent will -- using what hope than level biomarkers. is for mainly not be again, study. to retrospective blood-borne in happening of the at is following the analysis with scalp of

Konstantinos Aprilakis

great. Okay,

I, so comparison And you're D-serine. to the a crossover Phase XXX for including

So taking expect D-serine of what nephrotoxicity steps studying? so, see if are to you're to you protect would doses the it? you And against

Roger Tung

not. moderate extensively in humans. D-serine in doses has would fairly been used We

we're a that dose been in using frank single toxicity. We, reports using, careful haven't and going course, dose. any be to be only terms So of there of we're the of will

feel of do concern as see a -- don't we the in reduction toxicity approach. So terms that with in taking CTP-XXX. occurrence likely there's seeing of that quite a We differences with renal market

comfortable further escalation course, feel more study So the we, of about compound. of and that much

Operator

Instructions]. [Operator

the line comes from Gould Our from question UBS. of next Carter

Carter Gould

couple me. a ones of Just for clarifying

look that to the data expectation the if before So to mg the still be the you'll is I FDA? favor? for meeting just even guess be clear, XX with the in your move doesn't Roger, studies warrants it, clear, And other I there, just, if then, you'll guess, go to wait piece to again, IPR data on registrational

Roger Tung

The answer question, the of yes. those is for to both Carter. Thanks

in ongoing its we'll the include are analysis placebo in study, patients with included XX-milligram So final arm. the who

have until really set arm the or full study the data study. So of of we XX-milligram the don't a the completion XX-milligram

really So we will have we completion until with of complete to indicated, but FDA that only also as dataset the that prevail to compound. have respect potential IPR, that a believe we the all to in protect wouldn't not have take arms. to I we other And we

yes, our move intent is forward So outcome. the of to regardless

Operator

Your next line of question the Janney. comes Esther from from Hong

Esther Hong

schizophrenia were is the treatment has Would follow-up, question positive symptoms? symptoms? and discuss and cognitive symptoms example, what So for a for CTP-XXX negative compared paradigm and and be you landscape Vraylar the demonstrated for patient when Can CTP-XXX for first schizophrenia. cognitive for first and treated symptoms negative improvement therapies approved on if as risperidone. for My then negative approved? is to would Vraylar. competitive be And potential treating later

Roger Tung

the Sure. for Esther. Thanks question,

So that just want specifically symptoms. I for for CTP-XXX overall schizophrenia, approval to to be is towards of negative directed make treatment not our adjunctive initial going clear

well of We are aware positive has shown in symptoms schizophrenia as D-serine negative and both cognitive as patients. that the amelioration

as total intent the then stable would medication scores. and versus to who XXX take And baseline an so existing look be placebo patients to patents' add at and therapy adjunctive have on

are are looked of at the to schizophrenia. a different a go of negative I being for In exhaustive but list, don't mechanisms number that landscape in symptom there terms in studies want through symptoms, negative overall certainly

that detail, Our understanding, some -- in optimal. get those way having at is studies difficult to have well-controlled looked that are to and is this in fairly to conduct a

not at as separate program approach indicated, a looking that the the of as indication. the intent negative right we consider But would adjunctive on at the in we're that will be The So now, looking towards take later first utilizing development to I therapy. of symptoms as compound.

Operator

Justine showing no call would time. am the this turn further I Koenigsberg. questions to like over at I to now back

Justine Koenigsberg

concludes you, you. and there. the Thank participating at morning. month, to Jefferies And you conferences and This Later our in see everyone, thank this Stifel we'll call. hope you. this be for listening Thank

Operator

today's concludes a participation, this you Thank have gentlemen, for and Ladies conference. day. wonderful your and

You may now disconnect.

Concert Pharmaceuticals (CNCE) 1 Nov 182018 Q3 Earnings call transcript