CNCE - Earnings call transcript Q2 2020 | Concert Pharmaceuticals Inc

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

Operator

Ladies and gentlemen, thank you for standing by, and welcome to Concert Pharmaceuticals' Second Quarter 2020 Financial Results Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker today Justine Koenigsberg, Senior Vice President, Corporate Communications and Investor Relations. Thank you. Please go ahead, ma'am.

Justine Koenigsberg

Thank you. to second welcome update. XXXX and morning Concert quarter Pharmaceuticals' investor Good

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

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

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

Roger Tung

Thank to for you, our Justine. Good today. across we've clinical important report I'm both programs. you progress us joining made morning and thank pleased

I'd review however, personnel. of safety each place, our facilities at staged the turbulent to and of the our that advancing COVID-XX a us reopened in while and ways. have patients many affected ensuring operational the the sites, had, the trials, R&D our of highlights to safety communities participating make the integrity maintaining we clinical clinical At company relating our to and our controls live-based for the in our our and and key staff priorities environment. trials. systems in manner appropriate has in few programs, goals our Concert, current top of I to support a Before comments like are our employees, We

is remotely will and For the future, there to the jobs when to of so for do broader can continue the a be we in not pressing office. do team, many our us need foreseeable Concert

existing and planned contact with to in be our clinical continue We close sites.

basis, to and practices, Our Maintaining regulatory successfully running. enabled nimble align ongoing and industry a relating local to up studies rules ongoing our trials has with guidance, site-by-site ordinances. us approach our keep best practices a on and responsive

for For trial, implementing priority. disruption the Keeping and top strategies early and our and approaches through team CTP-XXX Phase safety minimize developing is to the I rapidly commend schizophrenia spring X summer. our

Our current study by complete CTP-XXX of continues trend to indicate year-end. the enrollment

Our alopecia continue the clinical to in first extend of CTP-XXX CTP-XXX to for accomplishments half XXXX areata. beyond and position advance program us

Designation ongoing on more progress. development Therapy There market. where Therapy improvement therapies. to and for to for potential has company look with our is one continued disease with our X review forward areata. no XXX interactions therapy works increased Breakthrough breakthrough the care are efficient color with you and updated to FDA that and be granted to tremendous were granted sponsors end-of-Phase existing We're trial Breakthrough for at aimed facilitate successful design, there FDA development CTP-XXX of and of CTP-XXX by the them. therapies XXX for the evolution Jim look development drug keeping treatments that pleased a first Concert. and we treating a a preliminary meeting the Designation adult now the CTP-XXX areata patient with turn FDA-approved the is to offer over are life-threatening to to expedite timely or for investigational and our applied Breakthrough for Following this medicines advancements clinical streamline potential patients development intended the designation serious substantial We earlier year, and advice, a front. for late-stage alopecia the and of as currently alopecia forward may review. moderate-to-severe evidence providing I'll to to FDA discussion Both on team provide dedicated

Jim Cassella

Roger. Thanks,

X first focus company discussed the of we development CTP-XXX in team, to as our as trial clinical mode fourth this major previously, we well execution start full are As in overall. with our This a of the year. Phase is quarter

patients planning along we've seven two or schedule roll As adults are either of met percentage the randomized receive endpoint baseline into of Phase of using opportunity conduct patients to a two moderate-to-severe Patients recruitment. in trial discussed, to Tool with X areata trial, placebo will randomized, randomization one change XX% we primary a support with of term study, milligram in are achieving placebo. long XX the in all only where greater This open label our CTP-XXX or twice-daily, the active a one NDA. treatment, assigned for trials or Phase our X ranging chance of completed X treated placebo-controlled milligram patients double-blind, in alopecia In weeks Severity ongoing are over that our or schedule, SALT. at on to patients extension gives efficacy major incentives from with to dose being XX relative CTP-XXX to of the be Alopecia doses

of Dermatology's significance March. We recently clinical in-person more these meeting after results the with both placebo or dose also compared groups stringent to canceled response Virtual in those less. data, who thresholds the of We a Academy SALT SALT-generated Meeting at achieved connection saw for patients XX was including released American score using statistical in

achieving results XX% At say achieved our their available than are These also in of versus a score less website. less and were cohort placebo, in milligram respectively. am of Achieving statistically to X study results highlighted of that less the and The of areata on Phase or on diligently or Concert or an twice-daily publication. physicians. program. patients slides SALT patients X.XX and been alopecia significant news P-value in less will or upcoming indicates which of cohort results meaningful greater a percentage X presence to than of Based X is scalp less. significant Our the fourth XX, testing our patients importance XX the Phase begin with XX% has a treating hair, SALT score X.XXX these milligram XX X late-breaking the XX% are quarter in patients the efficacy clinically a XX pleased the primary team week to endpoint I the year. Phase the our XX SALT measure, and be be both this of shown of for of twice-daily by from working

alopecia investigators among a sites offer Phase new and the Briefly CTP-XXX. on been tremendous. patients forward We goal to for Additionally, treatment meaningful through has the to enthusiasm with and the program moving look study X areata. option

have strong pleased Virtual opportunity of Phase we showcase the into Meeting to to the program program the May. the provided a American are had late to Society II. presented advance foundation data We in The at Clinical Psychopharmacology

D-serine produced For that drug to the at scientific important we we the X.Xx like pharmaceutical exposure schizophrenia. the areas ASCP, session first to Also, Phase time area wrap results a relative CTP-XXX presented at pipeline Zoom audience. during CTP-XXX to approximately a findings well-attended an frontal brain nonclinical higher of meeting, showing in I released cortex, our

for grams reminder, favorable to a tolerability safety, profile. X demonstrated days, a As of pharmacokinetic X CTP-XXX given consecutive and up

program of XX the urine and has dosing. signs trial. in blood renal about for in Importantly, confidence it's ongoing I in suited function of so trial, any impairment CTP-XXX Phase not and long efficacy very markers our once-daily of did an indicate advance half-life us well as key giving dose-ranging kidney attractively hours the we humans,

appropriate our With the CTP-XXX believe found dose the fully potential to range to D-serine its X grams increased in is rats, in of X, exposure CTP-XXX trial. we increased brand exposure X and PK Phase of compared II and the in benefit once-daily assess humans, administered of

trial is and it As to be expect enrolled mentioned, by we Roger for in fully Phase enrollment the year-end. ongoing, CTP-XXX II

the of screening to is an treatment XX weeks reminder, a initial with incoming As eligibility patients. duration assure period extended

trial clinical We trial. to the patients detection days are working slowed during continue and the study enrollment we of for while and progress COVID-XX of closely pandemic, site. see early And on with the staff peak each

the III in completion excited CTP-XXX Phase in about year-end. moving Let expected me extremely enrollment Phase of reiterate how trial into testing the are QX we pivotal and CTP-XXX by II

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

Marc Becker

Thank you, Jim.

in XXXX. expenses to QX The to other On during development were was CTP-XXX was expenses. a offset CTP-XXX, in primarily the and increase by on spending increased certain quarter development found XXXX, of R&D related Revenue our Phase recognition and licensing basis, for second of $XX.X of 'XX XXXX quarter million please review same expiration II during our the million related savings financial I release. the the tables was of noncash As options the $X.X XXXX to reference XXXX the second results, due quarter Research press today's to Celgene. CTP-XXX the deferred period to financial under with $XX.X expenses. development year-to-date related platform compared revenue second arrangement million

through in XXXX. savings to compared is fees for and schizophrenia for QX move expect decreases we alopecia attributable 'XX CTP-XXX XXXX, $X.X will on increase and advance Phase legal fourth 'XX to further QX that million employee expenses General CTP-XXX to during into million quarter the provided and period same develop areata prepared as were of As $X for year-to-date The expenses the basis. III continue a testing costs in in year. this and fees R&D administrative to we we lower decrease professional

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

the we'd prepared we to the Concert a we to concludes development and call investments. questions. expect continues fund that current advance assets to half $XXX.X Finally, happy looking second cash of in we becoming late-stage ended our its and operating equivalents cash, be and our have XXXX. Under to forward continue two commercial This are remarks XXXX company. the to wholly with drug the our blockbuster owned potential open quarter million second plan, cash each into company of to

Operator

And Securities. from Joon Lee Instructions] our question [Operator comes Truist with first

open. Your line is

Joon Lee

progress. thanks congrats for taking question my and on the all Hi,

we've recently investors you some that and Breakthrough cosmetic. for is the Designation is got So mostly of perspec's alopecia AA that from Therapy gotten areata

areata? designations into have of a So dialog what And follow-up. sort went for getting I XXX you. Thank breakthrough alopecia

Roger Tung

has, considered disease. now, FDA some alopecia time So, to be serious areata for a

they several of attendees As of was on have were a FDA more XXth the, a it was some time. effects patients how patient-focused development that I that had Designation, of the meeting, is very only safety areata. Fast-Track attended think, which for to which a held individuals meeting, have serious believe, And it. alopecia clear, we who reminder, the years I number also held. there diseases record-breaking ever at serious And ago, reserved initiatives And the was drug disease for all who

very that who at and little question more of disease. trajectory serious life cosmetic really the change individuals be who this are effects alopecia is the disease. And think So point, a individuals many I have the than the they FDA, areata, the course that in to consider there of sense have it

Joon Lee

you you And follow-up study second have the the And fourth confirmatory so Would on full the when so, study? the do anticipate in quarter. that a second is, need you confirmatory starting approval? study question for starting disclosed if

Roger Tung

will we individuals, of and ICH to that to logistically it's assume will easier get two drug, the to who significant exposed which through study. We patients rather We have of have require than number one. a were studies second need number

that Our year. next will expectation the start second is study

Joon Lee

linear scale XX% Great. of loss? is And And more was [indiscernible] what or score then the XX and less question reported the SALT one, you is so response? you. score Number SALT Thank or secondly, XX% final percent placebo share achieving the less. with my that,

Roger Tung

Jim, that, please? is. It could answer you But,

Jim Cassella

raters the -- the SALT XX% and score a amount is so yes SALT scalp. XX the by placebo of an So, trained hair response, of under the the assessment loss had the on for we for response placebo

trained of detect amount mean, with scalp. pretty it's So, I on hair hand the but, that the raters yes, much hand extent the goes loss linear changes, these in to it can the

Joon Lee

Great, so thank you much.

Roger Tung

Joon. Thanks,

Operator

Thank our Raycroft next And Jefferies. you. comes from with Maury question

open. is line Your

Kevin Strang

for Hi, this Maury. is Kevin here

the responder I ask your twice-daily you on in a analysis. of score wanted that primary than looking on to planning is endpoint XX ask more XX, non-responder? Are X. less that milligram SALT just Just running patients versus -- the responder Phase XX% study exploring characteristics had that makes -- for the wanted a these baseline so of achieved for a patients? you about mentioned differences you to which What

Roger Tung

Jim?

Jim Cassella

a great It's question.

program, we into think responder non-responder the of on go that or studies. doing and there what many so purposes makes I registration plan things of kinds for a our are don't those

understand our right is the really However, make now the that regrowth. hair between drug focuses to recovery sure of the we and relationship

individuals the get areata. know JAK registration We that on inhibitors on these plan characteristics in this coming will at will baseline that. the we be similar down and that -- focusing like road doing moment. we studies as be don't more program, understanding we'll have the be and So of But for of think we this I these alopecia studies

Kevin Strang

Great.

Roger Tung

Kevin, I'll also...

Kevin Strang

Yeah.

Roger Tung

Roger. This seen complete even very responses to they not extensive, been loss although, also more had that I'll had hair add is we've to-date, relative have have formal as good patients who from have that loss who patients says hair studies. a of Jim of limited

Kevin Strang

And then PTAB you. other the case. tell if any delays thank potential Is patent with Great, a anything us pandemic, is etc? you question there pending due just there further quick on to surrounding can that

Roger Tung

I patent we since specifically to tracking, subsequent of and the the Court the should session fall. the we a the that XXX may coverage expect result pending the as as compound But we not their XXXX is for lot analysis a until we a just is from it's patent, of believe question, hear -- -- of case, Well, say. they from year. reminder, which know the in that exclusivity issuance your Sure. important Responding that whether something to regardless, through of late so the hear to which next a us that drug, company this the patent case we're a the not independent less Supreme to have end it's do do or provides assessing while

Kevin Strang

That's helpful. you. Thank

Roger Tung

Kevin. Thanks,

Operator

Yang question comes Thank Difei with you. And our Mizuho. next from

Your line open. is

Difei Yang

thanks and good question. morning taking my for Hi,

CTP-XXX, gating factor the Phase to X? start regards with what's to here, second review a the Just

Roger Tung

answer the question. want to for you Thanks do that? Jim,

Jim Cassella

Sure. these study on first are focusing we Difei, large as we so are and studies, getting the started mentioned.

in also be So will the major getting a study effort second Phase III underway.

likely is that study. and on we're first sites will of will we sizes than new using be the running, getting logistical which our different Some so up be that for really focusing

of little We ways, So bit studies trial we these first. in and the that some get it's both logistics up months X coordination and within running. of that second a could started to get anticipate of

Difei Yang

on CTP-XXX, IP but continue the Then on situation.

So you these the alopecia, do indications? you with in patents to In protect go additional the pharmaceutical patents. expect if -XXX case, beyond composition

Jim Cassella

our use -XXX patent, and other in but cover Phase successful We -- the the areata, Difei. II CTP-XXX, only the patent that those. the we in apply Thanks, for not alopecia the used it will covers study extent doses to covers and uses of also regimens to method it we that those

a that stated process additional As what that reminder, say, I is applications, are filed. or before of filed we should we have we patents we have in being have or that

expect substantial uses. alopecia [indiscernible] of areata we coverage So and XXX there for to be

Operator

Ladies back now questions time. to any to and Koenigsberg would gentlemen, further Justine I any conference like remarks. showing I'm further this at turn the for not

Justine Koenigsberg

of month, you. at Thank at to you us to like we'll We'd conferences everyone this concludes many Cantor call. for hope you. and note, morning. with joining these events. the next today's participating Thank be This virtually thank Please of opportunity and meet have Wainwright the to we one

Operator

gentlemen, for call. participation. conference you your today's this concludes Ladies Thank and

a You disconnect. have Everyone, good may now day.

Concert Pharmaceuticals (CNCE) 9 Aug 202020 Q2 Earnings call transcript