CNCE - Earnings call transcript Q2 2021 | Concert Pharmaceuticals Inc

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Justine Koenigsberg

Good morning and welcome to Concert Pharmaceuticals Second Quarter 2021 Investor Update. Like last quarter, our prepared comments today will be brief, so we can jump right into the Q&A portion of the call. Roger Tung, our CEO will provide the CTP-543 key highlights and then Marc Becker, our CFO will walk you through the second quarter financials.

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

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

Roger Tung

promising clinical we data development study and This Justine. execute to you, We open-label continued presented our past areata. from quarter, additional CTP-XXX long-term of of we the balance Thank for strengthened alopecia pivotal sheet. on CTP-XXX our

Importantly, we THRIVE-AAX, remain the in file for second on XXXX. quarter, part second trial our our CTP-XXX the In track of NDA Phase to initiated we III early CTP-XXX.

a Between THRIVE-AAX and has are expect III a NDA. to for As studies with studies, X,XXX one extension we Phase receiving this other similar the treatment enroll THRIVE-AA alopecia a to trial. will longer completed more database, than moderate-to-severe trials number patients trials significant our to individuals study support safety the long-term a two These year sizable design us of areata. and with than ongoing provide reminder, including

to treatment of progress engage be to CTP-XXX the areata. We continue a for community in about advocate with alopecia the vocal treatment and needed the

Currently, extension last at patients For XXX for open-label Xnd years. had at study findings with Development over CTP-XXX the dosed month, ongoing the Summit. we Inhibitors from X.X example, opportunity to have the present least CTP-XXX JAK been Drug

generally Phase studies. study. patients in study in Treatment with adverse participate high continue the of continues well extension II to the events with the eligible reported a consistent to CTP-XXX elected tolerated those percentage Importantly, to be have with in

a patients our were maintained be Importantly SALT the the treatment areata and vast priority remains the improved or majority for for business. continued top the assessing potential areata in study. to alopecia has best-in-class alopecia of hair CTP-XXX who in scores regrowth

on to the expeditiously deep FDA-approved focused by THRIVE-AA was important in notice proud is the to pathway CTP-XXX. advancing program enormous team and Phase planning industry areata for There treatment III we're of need an NDA. and clinical an executing first of Our regulatory one the that Concert into take is the this alopecia is for for disease

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

Marc Becker

you, Thank Roger.

million financial in expenses to we review compared asset capital ongoing As in quarter Phase today's $XX.X were bring XXXX monetization the XXXX milestones XXXX during during balance and I XXXX. to primarily advance of III quarter $XX 'XX the General non-dilutive our release. QX expenses III million and program. and XXXX XXXX. service compensation. same sheet period to the to were our increase administrative outstanding for results, tables the was to of compared its CTP-XXX the noncash and our CTP-XXX clinical was Revenue Phase under development The second $XX.X $X.X $X.X in for sale press program. the in financial the Vertex. second reference of please were second million quarter happy Research was this due We strengthen additional as to continue to million through stock-based 'XX same period primarily to higher external attributable increase QX 'XX The during million QX expenses related professional found

would This during to remarks our XXXX. we the in current operating be million Under cash $XX share and per questions. prepared concludes was quarter address to cash to share happy in compared the plan, Our per cash expect period cash equivalents we our second and into fund XXXX. same We million net ended the second the of XXXX million equivalents. $X.XX and company $X.XX 'XX of net any our income for or QX or with of a quarter $X.X $XXX.X loss

Operator

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

Your now open. line is

RoyBuchanan

It's Jason. for questions. taking our Roy in for Thanks

Just a characterize results you fine. patients the blinded. they're just like in going trials have with you two and enrollment couple just And what their announced. wondered Any It are sounds one can of trial? were Phase drug from then, I share on results any comments is recent the if the THRIVE-AA, investigators ritlecitinib The that their or seeing trials. to the feedback recently One Pfizer on questions. that Xb/X from the Thanks.

Roger Tung

in afterwards. Jim, Thanks that start you I may could question. for on the and off chime

Jim Cassella

Sure. Yes.

the the trials So know, are ongoing. -- you as

can't we details enrollment we our continue next the on progress of with really dates for trials for trial year and as in the the THRIVE-AAX both and But nicely we comments are THRIVE-AAX. with second regarding make completion anything So to track early -- half expected on trial. any the projected

As far go -- ahead, as Roger. the

Roger Tung

No. Go on.

Jim Cassella

Okay.

I the think any to data speak wasn't release of press ritlecitinib. really there in for

it's trial. that to So hard what really seeing determine in they're

Roger Tung

that. for you Thank Yes.

Roy Buchanan

Fair you. enough. Thank

Operator

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

Your open. line is now

Farzin Haque

for Thank taking for on Maury. everyone. our morning is Good you Farzin This question.

study? Phase Xs. the is are you to the any thinking the given on two in follow-up Since enthusiasm to Just the potentially enrollment focus innovations of there, accelerate

Roger Tung

Jim?

Jim Cassella

I mean, yes.

things we going program. THRIVE do So all to the the we've need in that implemented enrollment to keep

towards we we the out both studies time completion that I have our been line. think patients we're think really have are all we I pulling stops trials from very both dates beginning So make the sure on projected. enrolled tracking to we as And that in

Farzin Haque

Great. Okay. taking you Thank question. for

Jim Cassella

Sure.

Roger Tung

Thank you.

Operator

from question [Operator Instructions] And our Difei next from Yang Mizuho. comes

now line Your open. is

Alex Lim

taking question. Alex This for Difei. morning. Hi. Thanks Good the is for on

help data then if just experience So other XXX showed we do how other know to hematology safety CTP-XXX, inhibitors JAK the what contextualize inhibitors? you from you of safety JAK time. long-term overall and see parameters, stable over to some you standpoint a from with data from was around hematology parameters relative recently profile where presented this could you relative I wondering

Jim Cassella

inhibitors Great Alex. profile. because known Thanks a know question JAK we Sure. pharmacology that have

et side continue are parameters all monitor been I we look the we've very as JAK to we we longer-term at the stable the is platelets, conference seeing that hematology and think that what what neutrophils, dosing. in things reported cetera, in recently key of

I I to there continuing look controlled very from coming reported, JAK us be at, to have is for out inhibitor important a trials. be longest think finding believe data because but the this we term for to also

So responses we the seeing that fact hematology a now data and out all to I be continuous think as very subjects we sign for go be product over this in our submission good is I of it's put we'll studies to we're stability able of as dosing in that -- there. year these our going important package, think very have long-term in long-term this

expected important thing is seeing a inconsistent I time. the But period the of for have the think I not to data as is for long stability think inhibition. profile parameters So we're we JAK dose that that these continue of we what shows with was good

Roger Tung

patients. Hi. of the the respect periods just is I know areata state to This in is alopecia of course, on substantial pharmacology underlying their said. But trials. studied the really JAK add associated effects inhibition, This states has are to and in and time want of that, Roger. that disease we patients. patients really with inhibitors Jim clinical disease been adverse in with that of therapeutically agree I everything for JAK effects with both other

that have in as pleased data areata with far patients So patient indicated, versus and alopecia we believe and see the safety terms longest very we so efficacy what CTP-XXX Jim population, is what in we reported in of have are studied profile. term

Operator

thank you. and Hey,

back As I turn like now call Koenigsberg remarks. further to no I'm closing showing questions, for would Justine the to

Justine Koenigsberg

investor you we keep forward updated on the section We'd morning, In you. like to please continuing conferences, progress. Events this to Investors to of for call. the website. and This today's thank upcoming everyone page look of for our the visit meantime joining concludes list us our Thank within a

Operator

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

disconnect. now may You

Concert Pharmaceuticals (CNCE) 8 Aug 212021 Q2 Earnings call transcript