CNCE - Earnings call transcript Q3 2019 | Concert Pharmaceuticals Inc

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Third Quarter Update Call. [Operator Instructions] As a reminder, this conference call maybe recorded. I would now like to turn the conference over to Ms.

Justine Koenigsberg, Senior Vice President of Corporate Communications and Investor Relations. ahead. go please Ma’am,

Justine Koenigsberg

morning update. to Good quarter Pharmaceuticals’ XXXX investor and you. Concert welcome third Thank

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

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

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

turn now would I that, like Roger. With call to over to the

Roger Tung

In been to in this our and results strong for have and for Justine we accomplished schizophrenia. XXXX, adjunctive you, CTP-XXX treatment candidates, proprietary generated progress important areata results very moderate-to-severe actively at of for good with and clinical Thank alopecia these CTP-XXX both pleased for enthusiasm with chronic address potential year, important the shown pipeline unmet and we’re diseases. with medical and morning. their presenting We’ve candidates’ of our scientific both meetings programs needs both

for new results In CTP-XXX, efficacy X a For a the last will have the benchmark Jim recap EADV presented month. clinical Phase treatment we believe alopecia moment, the in set at of areata. results

be for promising efficacy trials. two identified of assessment With with in and CTP-XXX which we future our both Phase have results, of X tolerability suitable profiles, may doses

a higher XXXX. we to magnitude advance into faster some X see The program and Phase CTP-XXX dose, greater including and is expect also nicely, testing progressing We in advantages of effect. onset of

and increasing fully these we two-dose once-daily reminder, our As data regimen are of are with These an of X year. twice-daily next the Both evaluating CTP-XXX. to helpful very characteristics end helping regimens and be a studies us patient meeting these we of dosing. enrolled, as define versus in dose doses conducting Phase meet will FDA database also studies of

reminder, a Circuit Federal a Court appeal we CTP-XXX the the our of decision notice patents. on of As filed patentability with PTAB’s challenging composition-of-matter

are pending to preparation. In by in application a other an and addition, for Phase results including we this have to X actively protection say that’s XXXX. hope in CTP-XXX, supported pursuing more impressive more several topic on IP applications We

about that a to positive new we is in a schizophrenia, which, CTP-XXX, results action non-deuterated form drug to deuterated CTP-XXX scientifically have a by D-serine, which D-serine, to treat turning of concerns. is of candidate mechanism with continues are our a offers supported of of medical is because substantial potentially, that activity Now by well-supported schizophrenia excited D-serine The is however, the limited it patients need. disease toxicity unmet clinical renal prospect

of We has much X non-deuterated product profile with D-serine. potential our the into will later that year CTP-XXX for a this XXX than confidence move safer Phase that

top from Avanir to In Concert drug in addition AVP-XXX, Phase results in the back proprietary reported to XXXX. our compound licensed is which September, Avanir candidates, a second trial for X line

of to number Avanir in evaluating is data indications. are not first not of agreement the activities from costs set neuropsychiatric AVP-XXX note to full trials meet and the the key of and best development our under all and note Otsuka studies there that explore important license have disappointed we were While that AVP-XXX of responsibility Avanir the and were that did our analyze its will and secondary – it’s indication, X forward. a for I they the multiple specific path that stated trial structure endpoints, its secondary parent, agreement, Avanir. primary will the ongoing with

Let me optimism Concert’s by conclude emphasizing for pipeline. our

data developed compounds, Mark significant and near-term multiple to year have Concert. ask clinical we results and and discuss create strong long-term we review pause like possibilities our progress, Jim quarter we’ve our the I the to will our proprietary call then to with open here would third this to before With value for financial questions.

Jim Cassella

Roger. you, Thank

phases last We a treating and news have continue Congress to and have alopecia to alopecia to proprietary CTP-XXX, both across opportunity dermatology session had Beginning platform schizophrenia we late-breaking Europe CTP-XXX the made well-positioned this International were of month. for for progress areata who provided clinical to excellent on the present development with their areata the CTP-XXX year, are showcase during the the into meeting clinicians, in programs to medical both program advancing our data in front U.S. community next the delighted development. at great and our EADV specialize The and X Phase we our

Let results me trial CTP-XXX. briefly the the review top dose-ranging Phase with from X line

to least the X in analysis was XX-milligram defined demonstrated a Phase responders X trial with of of for significance primary relative clear twice-daily at results is twice-daily baseline. endpoint in primary compares placebo as a statistical each the doses. proportion reduction very XX% the dose-related X-milligram dose met response, the both endpoint SALT their and score active between achieving compared and CTP-XXX The at XX. and the reminder, Phase responder a A the patient groups As week

placebo respectively. refer to as discussion, response response. patients in twice-daily development. cohort from placebo groups will which For XX-milligram statistically cohort XX% X- the and from not patients significant cohorts, XX. carry-forward the dose The later-stage X-milligram of XX-milligram into the the of X-milligram ease X-milligram week XX-milligram at was rate, a and be X-milligram a twice-daily XX% and dose and were will not responders showed improvement of XX% XX-milligram cohorts, The in had cohort and X% each significant the I twice-daily

from group SALT least and was XX% achieving with that Let with levels XX-milligram at change. was different placebo, a improvement improvement further XX% XX-milligram of The note at at in the significantly response the XX% XX% beyond me observed SALT. a cohort also least improvement XX% SALT the in cohort achieving

group For find the statistical XX, the XX% placebo threshold, XX-milligram separation a at only dose significant the also from dose starting for not we week we X-milligram from see a but cohort. separation

higher XX-milligram the with X-milligram dose. provide threshold, additional the dose response over to appears So an benefit this

cold, well-tolerated cohorts events in experiencing The percent the the the between Phase and adverse much response event XX-milligram dose-related SALT, Improvement they headache, of with The Patient a as alopecia receiving was treatment hair favorable and saying dose In we patients common serious a adverse either trial. entered XX-milligram nasopharyngitis adverse very One most infection events asked X group. nearly were the show to compared to patients that generally and completed after across analysis was was loss cellulitis Scale reported who placebo and addition very cohort, XX-milligram, common when X-milligram XX or and CTP-XXX of of from Data similar sense respiratory the XX% reported tract improved patient the interruption, after acne. secondary for study. improved Global their to or was much groups trial. reata in resumed their curve, using also alopecia the brief dosing endpoint. patients treatment upper in rate improvement weeks their was of treated Impression of a for

data best-in-class areata. treatment product date, for the CTP-XXX profile generated potentially have on alopecia we and to that as has we compelling a believe Based a

treatment no highly encouraged tolerability its Phase We for path for are by forward offering efficacy a into moving and XX-milligram product twice-daily patients X-milligram today. option the towards data it FDA-approved and this and alopecia X with a We further community Phase to suffers look options new advancing areata, with doses. the that candidate treatment X on

turning results has that developing non-deuterated an D-serine. of the D-serine deuterium CTP-XXX, program. much product give that profile us confidence non-deuterated the demonstrated multiple form non-clinical in Now, than our compared modification are adjunctive has we X deuterated as advantages for for our that of treatment schizophrenia, Phase to potential a CTP-XXX a to D-serine safer initially

significantly CTP-XXX In variability been in the to doses X our reported Phase brain The evaluated we tested, in profile, inter-subject which X multiple in range improved safety D-serine. CTP-XXX trial dramatically for dose dose has favorable compared single well-tolerated pharmacokinetics a with show rats assessments be exposure to CTP-XXX with lower addition included D-serine. a trial, to much than saw clinical In displayed was Phase the renal and testing. that safety ascending over higher

blood well Copenhagen. poster community in The of markers the kidney very Importantly, urine any enthusiasm non-clinical of The was key data, impairment. high and and new presentation broad CTP-XXX schizophrenia. X European psychiatry did not was indicate from consistent signs at there treat received, mechanism to a for clinical trial is Phase with early Conference September a our Neuropsychopharmacology in College function of renal for presented

grams medication. change antipsychotic used schizophrenia endpoint total randomize explore of will commonly a a to treatment will together, CTP-XXX. and The the once-daily for X be primary our safety versus who their studies. existing data intend suggest XXX we over PANSS a CTP-XXX dose to our XX-week efficacy and that be to study approximately period. be trial We in X stable able Phase a evaluate The are placebo Taken rating range X X X, trial evaluating therapeutic on will the sufficient of patients, robust Phase score, scale

XXXX. We year-end to by expect have data

McLean of for ahead, serves very week to Psychiatric and Molecular his opportunity in discuss has Coyle happy next mechanism will Laboratory is currently At a psychiatry including is Neuroscience with at forward lab the professor next webcast neurobiology neuropsychiatric an schizophrenia. who have event serious Dr. and of for be hosting event, hope webcast and CTP-XXX, schizophrenia. including with for at Looking psychiatry informative to Coyle’s work the of the and Coyle, and we are more an Director We of look understanding us. on Joe Dr. to Coyle been the a influential discussion Harvard join the Dr. further He as NMDA and treatments, will utility field thought School Dr. opportunity illness Hospital. focused of esteemed in D-serine leader Medical is that for the effective schizophrenia. you mental week’s very developing the

and now here financial ask pause to the results. me Let Marc review

Marc Becker

Jim. you, Thank

the XXXX review results, ongoing of in clinical in an including of support as expenses I the of our quarter the increase found and quarter relates to third million to development development clinical trials CTP-XXX, reference $XX were quarter of As in primarily expenses million multiple please and financial CTP-XXX release. with to compared The financial press Research development. clinical tables the as the XXXX, million. associated in today’s increased increase expenses of ongoing third well $XX.X manufacturing $X.X development research third

reminder, a resources are financial these our proprietary candidates. dedicated As to

the AVP-XXX, collaborators. development programs, For responsibility of our are our partnered including costs all

to attributable XXXX administrative The and of primarily third the decrease to and $X.X decreases in were $X.X employee-related legal period quarter compared million in XXXX. expenses General expenses. for for million $X.X of the million same is

net XXXX. in $X.XX per net third XXXX for was the million of third loss or per $XX.X Our loss the to quarter of share of million a quarter compared or $X.XX share $XX.X

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

approximately of Phase $XX next net We the fund year Under expect the million, through million in is Vertex the to quarter. our received we burn advancement our to operating from into first XXXX. is including cash $XX in company cash position plan, CTP-XXX the sufficient year, for our believe X proceeds development which current planned be of escrow

remarks, questions. answer prepared be any happy concludes and our to we This would

Operator

from [Operator Stifel. Instructions] comes Your Walsh first of Adam question

is line now Your open.

Edwin Zhang

for Edwin taking This on Adam. for the Thanks Zhang questions. is

Our is first question pipeline. on

emerging are the from a what next potential XXX, and your program pipeline? have follow-up. And clinical XXX I Beyond

Roger Tung

is very thanks for Well, This the Roger. question. Yes. much

think ongoing expansion certainly exciting come have potentially forward. and most But have we entities that are assets that is the neuropsychiatric neurotransmitter. communicated conduct effort compounds. additional effective as So we use existing potentially by multiple in that compounds believe by could to previously, for XXX, we’ve of pipeline right we our particular, there In of that that treated for preclinical at an indications number a now are pipeline clinical looking indications

Edwin Zhang

you legal to Officer. any issues? you. Okay. milestone remind shift new appointment, us Thank can is coming And We the on know Related new the there months? strategic Legal IP the Chief named this you current a have in also,

Roger Tung

terms Well, in milestones. of legal

vigorously As dispute I discussed, may aware, filed, to going you a the we PTAB forward. challenge be ruling intend to have that as and

oversee our In the and as that’s we of our give to forward strength legal a strengthen Chief Officer, us whole the team new to appointment as terms function to endeavors. Legal in legal move a really executive of

Edwin Zhang

you. thank Okay,

Operator

you. Thank

question of next Your Mizuho. comes Difei Yang from

is line Your now open.

Alex Lim

for Alex taking Difei. you for Thank This is the on questions.

to for one the assuming BID shows first or test us could So and you both remind then similar just went CTP-XXX, both safety? that the QD Phase efficacy on into do you dosing considerations expect one, And X, QD dosing? testing the trial and regimens

Roger Tung

thanks the Yes, question, Alex. for

a with terms is So never of understand in regimen the regimen best or assess compound to And better pharmacodynamic if disease. a relationship treating this CTP-XXX, its as we’ve are context and our otherwise in compound dose that’s simplify hope and to there really the dose areata. pharmacokinetic, discover opportunities indicated, is the primarily, studied the how administer of been mechanism to to for to alopecia the

the In to addition number be benefit Phase are decreasing been the to who who exposed of it in that, the patients study. the compound increasing have going has of to patients the burden on and X

spoken doses what until assessing XX and going twice-daily We we terms the the regimen expect won’t do to XX for appropriate that. FDA. with to be We may – we the we’ve XX-milligram see able studies. dose do question Phase and X in are depending what of X-milligram into be are So forward really both we with currently X, course, that the Phase and upon of studies, think answer

with note XX-milligram I’ll as However, doses. than results, X-milligram also with we’ve dose the response seen the some we particularly better have stated, at higher the that,

is be we’ll actively talking about agency. the with something and assessing that So this we’re

Alex Lim

XXX great. on symptoms? measuring the remind Okay, switching the and to XXX and negative Phase positive positive And And for outcomes us maybe you to rationale symptoms? just expect then trial efficacy have X design, on both do then the

Jim Cassella

is this hi Yes, Jim.

does ways on is we positive support functioning. both that cognitive us as well yes, D-serine negative many and the in So symptoms improvement tells special it so as in and – literature that very

So for encompasses is endpoint, score, which PANSS our at of those rationale looking total the the primary all domains.

covers looking negative at So be and as score, a total we’ll which our primary of endpoint, sort general positive, psychopathology.

So endpoint. primary that’s our

as able the those For can go be the symptoms symptoms improved positive forward. negative subtypes negative to we of as domains we that and pull we as literature symptoms does move functioning. out well as will positive looking analysis at us cognitive But symptoms, secondary and tell

a gauge looking at So overall domains symptomatology. way as to of the looking really the we’re the well as in patient trial improvement as the at their X Phase effects individual on really

Alex Lim

on you quick one, if a PANSS the And would positive could may, score? last improvement Okay, the great. there one meaningful just I symptoms anything what in share the clinically – versus be negative

Jim Cassella

for in powered looking total Again, the change we are score PANSS. at the

will a X-point in trial the the designed meaningful. have least to placebo and X-point overall And total is believe score. improvement to versus powering powering the So how a over so show that designed clinically that’s total we placebo is at we’ve be difference the at the to score, also look

Alex Lim

Okay, you Thank great. much. very

Operator

from next Your Hong Instructions] Janney. question of [Operator comes Esther

now is open. line Your

Esther Hong

taking Hi, my thanks for question.

non-deuterated did some information on studies additional So, on been studies, Any Can of those any non-deuterated background D-serine? And CTP-XXX, provide investigator-sponsored have there if studies so the of sort endpoints? how on background score? Thanks. those at primary outcome, the D-serine. they PANSS – you use looked

Jim Cassella

And score There time. answer the the been do actually, around PANSS. are specifically a have And D-serine we’re long they looked been of PANSS. that dozen a And in movement those have the special NMDA about and People D-serine negative subscales, Sure, in a the question hypofunction movement reported, back details, symptoms studies positive you the at commonly positive doing. results positive. the clinic, it’s history, studies of been they and do great an and the been XX has question over To of the probably on absolutely, has hypothesis movement interest at the the the have the on a see total is think have cases a some the long good when of have It’s symptoms. And your where the can symptoms in on portion years, Esther. use question. there because looked negative Thanks this hallmark at used. total goes specifically D-serine look a I see hypothesis, you literature. area for like for

look have I are trial, designing some those and drug in very that looked results positive patients, also all a of been we on ones the results they’ve and been at we clozapine inclusion varieties the at ones we showing can at our the or different looked There some haven’t at clinical positive been benefit. been that that also of but exclusion studies the shown at or that like the that think, have previously positive drug the looked of and criteria. and glean studies well, to we differences from looked learn studies, for they’ve there’s have what where between those negative papers see we’ve educational our from us at published been in-patients well, and looked top whether as have studies in

with that these at basically, pull talked Phase Roger? we really to those been involved forward best the program D-serine have for KOLs benefit. be long to So with – time. and our our X optimally with have we’ve really the looked a looking for X And designed Phase studies, out and designed We’ve

Roger Tung

Yes.

other shown Jim. level. A them D-serine studies that the in CTP-XXX, which mixed about inform of studies thanks, is comments more So a results and general the how one at couple lower-dose conducted were clinical they have with of

per that were per or So to those uniformly appear dose doses, the higher at roughly X per as kilogram at at was the day. be you XX-milligram conducted look patient that level positive. And grams studies

the use. doses relationship to are of the that has to So the we of think things terms going PK/PD led that’s in that us about one thinking about

in D-serine. As than substantially in brain we with exposure the CTP-XXX Jim do higher preclinical our see in a we noted, models

the are study, the readout grams us in that – give single a properties per as low X it out prior in stated we variability treatment going to so day clinically level to to covers to in the contrast PK for relevant what’s discussions dose which things of that high good And did expect one been of that’s range XXX And has of doses. And per on the that’s has we very Phase doses we pointed ascending that person finally, D-serine, for in have X work going adequately both in up the a schizophrenia. adjunctive has XXX dose in in that and remarkably we inter-person of assessing our study, is variability it reported multiple that assessments. the been

all those to profile the as, favorable well think safety I a points hope that we of renal XXX. obtain So as course, improved of for to

Esther Hong

Okay. until any just follow-up, speak a little And thoughts for potential you the you with a schizophrenia wait symptoms data Phase opportunities X or XXX? then that? Thanks. then expansion from the can associated in bit on study about Will

Roger Tung

we’ve evidence a a as indications native CTP-XXX as in neurotransmitter, certainly version schizophrenia human indicated – there’s deuterium-modified of Well, a altered, is neuropsychiatric of number others of previously, a endogenous which alterations it’s and is of that there’s think for other disease is – schizophrenia, its in if states. indicator in We we in neuropsychiatric that’s to well. movement certainly this potential see a positive disease. be a And going overlap lot

actively We the move X the any but study, we to in something to we’re readout haven’t going that’s Phase of to additional as indications made forward yet whether decisions that assessing. are prior

indications, we’re identify at this multiple not for but disease As specific XXX, there time. the treatment may with a far as ready susceptible to there which states, is one some indication are be specific

Esther Hong

Thank you.

Operator

you. Thank

Your last Garner LifeSci question comes of from Robin Capital.

open. now is line Your

Robin Garner

my I’d of structure lower that elaborate for Could questions be questions. like on variability? aspect leading inter-person its ask a to you you thank might on to you what taking and morning Good further CTP-XXX. few

Roger Tung

We for up-taking the know that is Thanks because passively not is It are and D-serine amino This really went both has membranes compound is itself. question. all transport. CTP-XXX don’t metabolism the active fairly acid of this a complex. pass-through Robin. variables by what Hi, and the

levels high we or the interesting there essentially us active transport very XXX, its periphery CNS. periphery which of linear, up absorption. into to as from is that aspect extremely high So and levels is move to dose an gut to into It the with periphery the absorption see of both the the we continued absorption from is

great we brain transporters. it levels see for like the So as noted, substrate I seems periphery. a much higher the also relative And to

in multiple of terms we being of So the by degrade probably down terms really that I can’t that effects, of of of well terms the now. you is all would specifics, that guess recognized in know it’s transporter its the degradation to it’s the pharmacokinetics, compound. able in specific and system a nail But by slower give the overall endogenous but contribution we right mechanisms

Robin Garner

D-serine, endpoint? what’s time given on range studies within we’ve you seen Okay, any or primary point the have that thoughts And of do share of a – thank also, can appropriate for you. you the kind already

Jim Cassella

Yes.

best the you see the we to on of at look gives opportunity us extent So to from out of things We it to symptoms, durability weeks. the gives things look studies early like negative looking effect their can few to the at that the the a we full you grow establishment we’re clearly, that at if we’re as those well. opportunity data, us little and have And ranged around really weeks. decided a a the in effect. see of bit as as duration think X effects course. – that, And the weeks XX treatment believe When XX-week

that talking a literature combination of lot looking of we’ve the in So and on by think optimized this I a at weeks experts XX space. to the

Robin Garner

Thank you. great. That’s my questions all Okay for today.

Operator

would no the questions. you. now I to At I Ms. to like further showing Thank back this time, conference am turn

Justine Koenigsberg.

Justine Koenigsberg

there. London everyone joining that Please Thanks. morning. concludes many Jefferies like both and call. month, Stifel This to later hope this would participating Thank the us. joining for you and we of for at We certainly to you today’s be will note Conferences thank see this us

Concert Pharmaceuticals (CNCE) 10 Nov 192019 Q3 Earnings call transcript