CNCE - Earnings call transcript Q1 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. Welcome to the Concert Pharmaceuticals First Quarter 2020 Financial Results Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. [Operator Instructions]

to host like call, today's now Ms. would introduce for your conference I

moment. Koenigsberg, Justine one

Justine Koenigsberg

and morning investor XXXX Concert update. Good to welcome Pharmaceuticals’ first quarter

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

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

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

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

Roger Tung

Thank you, Justine.

positive throughout months During positions and the in and important quarter year creation Concert past have ahead. XXXX, developments milestones value from that clinical in achieved we

proprietary team two to late-stage testing year. worked both of potential diligently be advance clinical next our have in has to which Our the programs,

beyond friends as so how our to citizens, Americans, our global world. neighbors, in much not impossible COVID-XX pandemic It's and look considered and impacted family business the has

have positively First, to we're forward COVID-XX. development and as impacting life proud vaccines companies stepped the to and be mission medicines, that part salute of takes an industry develop its that for we therapeutics the

have trials other companies clinical to have and broad pandemic acknowledge impact also that on will We the indications. conducting

COVID-XX. ongoing runs of situation our the have in the an course development throughout close in planned COVID-XX and provide we'll its to are clinical update as candidates which the time. other and We've remarks subject we territories or operations. of advisors in U.S. Today's reassessment is monitoring real clinical KOL sites been clinical two with and in status In our touch light our on today, update

cover me let First, CTP-XXX.

are patients treatment and the for need for bring product XXX We effective safety addressing profile, are and highly we to this an areata advance alopecia profile favorable to meet it for continuing on focused a believe set to a we for the in be ranging generated new The we clinical trial areata. what Phase dose treatment as quickly X to efficacy as benchmark our alopecia possible. of data in CTP-XXX

profile. CTP-XXX JAK Among have possible developed provided potential the for we is the quarter results CTP-XXX fourth inhibitors most Based have year. results, alopecia to these a it to-date to treatment in clinical X appears the trial. robust very to this the of with areata a disease, favorable on the be in early any this feel of track being reported controlled efficacy in an market trial entrant on initiate product for to We Phase remain

study when patients, added start antipsychotic we the project schizophrenia, year-end. for great for to positive negative the enrollment Phase candidate dose to our cognitive CTP-XXX, improve CTP-XXX a completing that to ranging symptoms to turning The schizophrenia to now COVID-XX got has including symptoms X primary enrolling but treatments. off a on due Now function, potential and believe we existing remain and in

describe support will to trial. completion sites working of our we how Jim are activities trials status with the and clinical this of

programs. with over As have the to both the point this stated reach us earlier, exciting our accomplishments of I Company's past year clinical enabled proprietary

are in our programs, we of our and we're times with the focused on the facing challenging aware communities Although, well we're future.

immediate diseases, for view, unchanged. two of our a our important In drug belief areata candidates of potential the With the people alopecia millions is result affect of clinical support have disruptions do of as them programs arisen the the in of and which integrity value longer-term that to to schizophrenia, keep working unprecedented we're spite and term, a advancing our everything possible Covid-XX. more in

at like overview pause questions. to provide we provide and CTP-XXX X our of detailed presentation financial results to the clinical look status to of Jim planned our to the to before a open will programs Then call current and an Marc turn I'd our here the discuss Phase trial.

Jim Cassella

Thanks, Roger.

further put me like Let with about other Phase clinical discussion control has ongoing spread. is trials, to by clinical study. start COVID-XX place impacted This our clinical study CTP-XXX and and some our that, its X many been policies in

read Here's out this we hold on up all COVID-XX conduct track clinical and across and to virus X in study recruitment complete to enroll were where on to-date, year, the the until policies a are activities we the patients time of programs significant Phase related put and country.

related With the guidelines all have or our visits state for study patients enrolled the sites already to study. the complete federal to COVID-XX, overshadowing within and the person to in study restrictions continued in of work remotely

the expect new However, as year might or activities temporary in the slowed screening have patients Phase study you for screening X of we enrollment enrollment this enrollment the of and by suspended expect, the at patients, disruption our of centers. With temporarily end. complete been

a Looking affects very we we disease CTP-XXX, drug of patients. millions at have bigger compelling a picture potential that with the major for candidate believe with treating schizophrenia,

comprehensively are that amplifying greater benefits patients. with treat these schizophrenia we agents effects We of CTP-XXX, hopeful current can by the the to and extending or antipsychotic more provide

of far. a programs minutes for a this make few we we've to an to data CTP-XXX, and CTP-XXX thus generated clinical alopecia planned like few in turn overview comments on I'd provide program areata the Phase to our As spend morning the X

As CTP-XXX a reminder, as treatment for a to severe areata. developing moderate alopecia we're

program. We very prospect of are excited about this this

placebo. X be completed last or X of meeting twice met with CTP-XXX XX-milligrams CTP-XXX primary efficacy daily end milligrams In of X year, raising conduct either Phase X our twice X doses randomized support or control are that of to placebo trial was patients dose Phase will on blind receive with to their of to trials FDA, endpoint. treated our daily in our NDA, randomized adults Based patients in Phase double two we planning X that discussions

severity to Tool, showed patients relative of of differences using XX of Severity endpoint SALT. relative More placebo, significant or change specifically, at percentage the baseline a in Alopecia the the from achieving or greater XX% weeks primary statistically

also more at as With our several data. response stringent backdrop, of Phase generated look program. all me at key We that SALT aspects X the threshold planned highlight closely significance let we more saw

patients the of Given doses areata and Europe. in clinicians approval adult patients the effects U.S., X, will real at both trial randomize our intent We use. severe to observed in XXX world doses options moderate with to intend both XX dosing X have study per sites alopecia and and Canada about ultimately so doses in with to and twice is milligram daily Phase seek the that these milligram

XX measure be Phase loss, a less absolute of scalp means patients has weeks the primary who SALT re-grown hair of least SALT X score is that The presence. outcome the XX for such that they an Since patient score programs of achieved hair scalp SALT following XX or treatment. XX% a will sufficient measure hair at percent of have

superior terms SALT data of receiving Phase score daily statistically patients X or or of from analysis less. were either twice of of patients the the our Our that showed dose achieving study placebo CTP-XXX SALT milligrams a in XX to XX X milligrams

years excited pivotal this here several for is advance moving to candidate about the drug to very worked have CTP-XXX testing. We and team

effective We we ultimately and believe in for and deliver understanding are Phase offer well-equipped alopecia solid a X to alopecia CTP-XXX's have and a safe areata. of patients in treatment areata activity

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

Marc Becker

you, Thank Jim.

As please release. first quarter results, tables our financial of I financial in review found XXXX the reference today's press

in related during and the research $XX.X expenses for million expenses X ranging and million relates CTP-XXX. QX dose XXXX, during completion development development same the $X.X were $XX XXXX, to in compared and primarily Research The study of the a of decrease to decrease pharmaceutical million. period Phase development

from the expect R&D expenses we to CTP-XXX moved we as CTP-XXX X quarter fourth develop testing this we into that XXXX, advance of to increase the in continue and Phase As year. prepare will

expenses $X.X legal administrative for during to in million is QX primarily were 'XX, $X.X the and attributable in The decreases million expenses. compared period to decrease XXXX. same General

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

equivalents of of cash, and end XXXX stock with proceeds Finally, loans a approximately $XX offering follow-on the net with cash common the pre-funded At $XXX.X completed with investments. first we we of quarter million. and ended January, million in

cash As all makes of of milestones are COVID-XX, a expect our fund as result, the for of under our into company. optimistic we us see our for a to we significant Company XXXX. year business the result ongoing to the second half current XXXX operating execution we plan, our challenges, continue a the facing which Despite as as

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

Operator

Jefferies. with question from first comes Raycroft Our Instructions] [Operator Maury

Unidentified Analyst

for Hi, Maury. this is [ph] on Swapnil

is to go? X. Phase XXX for So couple there it just and is gating trial are are regarding you of Or any all this to good factors One questions. clear XQ, a In start?

Roger Tung

that? you take Jim, could

Jim Cassella

Sure. Hi. Good Yes. morning.

had the So, we great FDA. a meeting with

We X be running. have one clearly up our time, the going getting in this logistics clarity on getting point the to in COVID-XX At the is protocol. trial is trial it of the going. Phase of influences and

in plans see greater start as trial be that. in difficulties QX, we'll the able but don't to So our very make doing we we any around expect to firm clarity the pandemic,

Unidentified Analyst

question Okay, that's on one and XXX. helpful

drug give And can bit you data X data to expectations of for tell forward about what that the little your into pivotal you trial? readout? like us a would Phase move confidence So, kind

Roger Tung

again. Jim

Jim Cassella

Yes, sure.

So, all as country. we mentioned has affected the the ongoing across trials COVID-XX earlier, clinical

by now is in readout will so to be our than that occur enrollment able year, more we'll complete likely data Our XXXX. and guidance end

done We out help have operational, pandemic. we we've could during the have sites as really -- as much our been to them

sites So, enrollment. can slowed on as some slow some were sites to had down imagine, really, you and

enrollment are at be then to completion end anticipating think, up able this a I and to So, we'll wrap year, of trial. of we the

this plan the do the we of before, trial FDA. results would Phase the X meeting and Phase end X as of on dose meeting. starting think, we trial with positive with trial FDA the after we we We for to a having Phase anticipate, need ranging the with think will I talked only is here, It's Phase discussions X X. we at

Operator

question from next Lee with Our Joon Robinson. comes SunTrust

Joon Lee

sites When know, compare any from clinics less. breakdown may may cannot that is, FDA? difficult approval academic the definitely in versus or approval requirements laxity academic to expect with the initial requirements? clinics, fourth And pandemic, reason proceed this foresee once for quarter? your be you you some if recoup from to study of hearing And what stringent X we're lot Do could you more maybe post can Phase you given be the will conditional with COVID-XX less the where a asking private private outpatient perhaps impact for if

Jim Cassella

go am Roger. sorry, I Joon. Hi, ahead,

Roger Tung

go No, Jim. on

Jim Cassella

Joon. Hi,

the in think I world. So, things we're shape the in start QX status to current good in given of

trial X shape worse be COVID-XX, Phase Canada this we as into the think look in are with anticipation good the in we Europe. again in from QX. U.S., part Our And things forward I will later planning is run to a perspective start of and get year, unless

virus, really good again, in again So, is think shape. downward unless trend are with I there a we the

COVID. what's the now, in terms with FDA trials with I we going COVID providing terms beyond much developed but current happen think fully get right going in out now, expectations, guidances it ongoing I don't to as of this that program. terms know of have period are once flexibility and a what's on regulatory has right crunch we guidance in as put of for can

We have a data. lot of

relationship we that to We are trials continuing the need NDA in approval. to to do track

So, and open bit a up be plan here execute a plan things we more. that as have little to we will able good

we've Phase have number program. We a of X the Phase obviously our that of for with X. working been We number will sites be sites expanding for

and selecting We able going and really sites very start now this that's we in where emphasis preparing to are to that, the I Phase be that are will this is feeling study, do of the right confident abroad our X. sites for are both think here be

Roger Tung

Joon, regulatory pathway expect I approval a would not guide to change though. the in you

this course our that, flow-through a the I think will is registration. normal expectation our be of

Joon Lee

question. more And Great. if I could one Great. ask

want discussed correctly. we this to chat, sure make fireside the on I As just understand

XX% Phase look understand completed to had X% fair XX% the that in study at SALT BID the baseline compared placebo. milligram the X XX that milligram have a If score to less was SALT assuming of BID X least outcome? the score XXX the XX in than and XXX% you in way would've Is and at at of you the baseline,

Jim Cassella

the in it is just I'm Phase X the than framing this less way endpoint XX. because

Roger Tung

don't I'm have Yes, sorry, the I graph.

So, go so Jim. yes, on

Jim Cassella

Yes.

XX an was So average the Joon, X, take. our average about in our give baseline Phase or score

Roger Tung

Yes.

Jim Cassella

You're right.

coming data loss have you is, lots hair tool fair we at the the cut the the amount a look assessment us SALT that's So, that to think into different of way trial. of ways. which allows And this I in could

look you data have change from previously XX% that of based baseline, have milligram group the terms the folks, of the when had, So, on percent who we or shown baseline. have XX% at XX change greater from did we've in

looking We we That at absolute score did a XX, had to were So, to that. going the able virtual SALT were be going course like at at XX we of AAD presenting data that look significance to an the now SALT and meeting. say that, be meeting. at meeting is we

to on trial you'll able analysis at from we So, X data data. will the new be able conduct XX be Phase we study the to our based we'll But SALT AAD, -- using analysis we powered Phase so that able those to were see present our our X specifically.

for based that think, quite know achieving on presented doesn't point. so really And about the presented that, will we meeting. data powering what be the this ADD the at is trial those far, end but the show we So, data you I

Joon Lee

presentation? for that the been date Has set

Jim Cassella

yet, virtual meeting. not have they announced It AAD been set has but that has a the will

Joon Lee

Thanks.

Jim Cassella

we selected the for breaker were late session. And

Joon Lee

you. Well, Great. it. looking Thank to forward

Operator

next from Our question Stifel. from comes Adam Walsh

Unidentified Analyst

dosing have Hi. to for CTP-XXX, Phase have X you this plan regimen [indiscernible] the Are you is from BID the And for in in Adam. the What the understand file? taking This year? patients switching dosing I I QX? a to that a extension is while is extension data then study use any this there study follow-up. Thanks questions.

Jim Cassella

This is Jim.

other were ongoing. X subjects extension into eligible term BID the X milligram that milligram or been have long the This were So, trial milligram study it now have rolled extension rollover our we Phase extension the either BID cohort we an dosing over and to from a patients the do It's is the XX study. well running studies into XX as as onto regimen.

two there in So, doses are study. that

Unidentified Analyst

Do this year? we expect data any readouts

Jim Cassella

talking that discussed haven't be to study. study. about We when long data a is going we're term from It

to of would not we if we it's would So, when would haven't that showing you, start of fair say data, I releasing think anticipate data we that but or decided that this any year. any we

Unidentified Analyst

We PTAB help the new do us second question understand any Can on PTAB. deposition patent my the Okay, timeline is here? you. spec XXX Thank at from you of judge? don't panel

Jim Cassella

unprecedented back we can't provide I'm much remands This very with Yes, you say PTAB. having on as sorry going that. that as guidance to is situation you to understand these an

they'll We we any to relatively expect to guidance. try specific act on that it give probably no have basis soon, but

Operator

Our Liisa next question JMP with from securities. Bayko comes

Unidentified Analyst

Neil guys, Liisa. on Hi, for

virtually, their sure say, to reason differently safe in any lots second of will it 'XX setting? the specialties, other is think terms be data be is CTP-XXX, the able to likely clinical trial dermatologists, think For of job I half not then good or psychiatrists, more we question, can of first And the do news the yet? to that, say, to

Roger Tung

Jim.

Jim Cassella

Yes.

that using our dermatologists well we're equipped the So, are we're for and I doing that psychiatrists right work that do studies to now. think

work some has sorry. centers activities. all had what terms the they're I really needed needed, that that repeat of with virus we're question? the overall first the sites their and mostly we've maintain and right which the Could to you very to of I'm had the to trial, think and we're We've things they make see the to they able think I what they're in they experienced, maintain sure psychiatry logistics in part to able well had things, trial really terms now. is but think XXX, running of I active really been impact

Unidentified Analyst

say XXXX, or the half Just not can sure first yet? timeline we

Jim Cassella

Yes.

expectation. on I So the track enrollment completed think first reasonable half to is if of think by the have year, I we're end the a

think a I first I impact of half end complete we the virus. the by if is think on depends enrollment it year, still the expectation. But can the of reasonable the

Operator

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

Esther Hong

morning. Good Hi.

the powering this schizophrenia, Does other potential trials? developments Thanks. there on for and CTP-XXX then data that follow-up any CTP-XXX around any any the for cases impact remanded? similarly in missing maybe the on visits So been COVID-XX because alopecia, for And is assumptions? pandemic have of

Jim Cassella

Hi.

say So, of of integrity say trial, remote fair continue I I'll flexibility doing logistics we've get the XXX. done everything done needed possible we around guidances It and allow actual it's me everything but talk about FDA. maintaining Look, and that, to to to think we'd of I within the also into all details guidance what can't with the let possibly to could integrity scope just the for did the And we by do. the the of trial that, the trial maintain issued the assessments.

Esther Hong

Okay.

Roger Tung

to of those respect the with been really Arthrex adjudication there to Yes, any not remands the further for as of or has secondary PTAB, studies action as trials. we're aware, far under remand adjudication read the terms in and

So, really the just right we're while things a about assess study, job group feeling our good the really very conditions. keeping relative tremendous the it's initial concerns. conduct think And, we're kind to emphasize challenging future, to difficult a want really Jim's under that, forward to I is regarding mode. now trial of moving done in where the I of wait-and-see CTP-XXX of has

it is continuing So, to forward. move

patients new quite We forward are in move to-date, if I think trajectory the will study continuing had that things and to enroll well. move that they

Operator

Mizuho question Yang next Our from Securities. comes from Difei

Difei Yang

and Good question. for thanks Hi. my morning taking

and symptom this from on expect the correct side well? we on effects quick of negative a as D-serine is versus versus the based data cognitive assumption one, that symptoms perhaps should positive available the greater clinical So, a just in a schizophrenia,

Roger Tung

Jim?

Jim Cassella

Yes. Hi, Difei.

very and There's positive shown in functioning. been very the on also symptoms. literature cognitive shown negative a some on the on nice symptoms think cases a has nice I effect effect

I approach captures is reinforced think score, which PANSS that to has the things. look all really three here, at our those which of total

the be discussed designed, at questions in are to able will cognitive and to functioning. go and those effects positive at be that symptoms related we course, PANSS the to are the past, Of specifically, items look way that those and we'll as are by that the we've able on look negative or in there symptoms also related

you're literature a I effect the favorable the symptoms. right there's assessment very been of So, is on negative think that

of one its domains very and we to mechanism I total It's think we're well. as hallmarks impact things individual of we interested in that's all the the of will ability of one the because in. domains, why also score, D-Serine nature that those that to D-Serine. of the look really that's be those able But symptom but looked much at

Difei Yang

Then a forward you, or There X so year move is IP Thank settlement subject changing maybe a Jim. the either a discussions, cetera. et a onto the from court there's decision say, competitors, with let's month-ish.

you do pipeline So, outcome there the the patent, whatever through any on for products is for the think the XXX Concert? of rest read

Jim Cassella

that really them. situation different and I think with a of products the surrounding each facts case-by-case patents each of the is

As a a a strong think variety different basis pharmaceutical has singular that, a toxicologically. that's patents is that had where in a of since And use well better of for aware the ever as Deuterium-modified you not competition that on on the non-deuterated tox competition case compound. in literature. compound We're provides that compound as it not observation, to toxicological CTP-XXX, a been case aware we conditions respect of strongly the What there's methods we're in properties positive to characteristics, unexpected of particularly we're are very compositions. relying a potentially renal with pursuing was, known relative has been

we kind patent, was to the of note the situation XXX of the a respect also that light litigation that, was around I to that XXX. respect issuance the have very And of with XXX do patent. in So, subsequent which XXX with legal it's different ongoing knowing than should there

on So, that and importance is independent specific pharmaceutical subsequent an impact it, XXX compositions, patent litigation. we protection that methods CTP-XXX, the of provides use of think really patents reduces important protects that dosages the a of which

Operator

turn to not to I'm And time. call questions like at this back further I'd the over showing any Justine.

Justine Koenigsberg

thank to candidates on look and you provide forward to everyone to as joining for Kevin. Thanks, We'd us this like morning continue they our pipeline updates progress.

For section please website. summary our events, the IR of of visit upcoming a

call. you. concludes This Thank today's

Operator

and Ladies today's gentlemen, concludes that presentation.

and may You day. wonderful a disconnect now have

Concert Pharmaceuticals (CNCE) 30 Apr 202020 Q1 Earnings call transcript