CARA - Earnings call transcript Q3 2017

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Operator

Good afternoon and welcome to Cara Therapeutics’ Third Quarter 2017 Financial Results Conference Call. All participants are now in listen-only mode. [Operator Instructions] Please be advised that this call is being recorded at Cara’s request. I would now like to turn the call over to the Cara team. Please proceed.

Michael Schaffzin

morning. Good Schaffzin quarter Relations update XXXX Michael Cara welcome conference Stern third Therapeutics financial with is and Investor to call. This results and and just release update news with third financial The our became X:XX after results available p.m. quarter corporate our today at www.caratherapeutics.com. website and found be can on

on You call to of listen of section also live webcast Investors may replay the and a today’s the website.

statements timing meaning clinical be FDA regulatory in remind of are potential clinical of of trials, of FDA design the for are on trials, the and milestones markets development and today’s pruritus to CRXXX candidates, statements multiple our regarding that for matters our the that timing not with concerning announcement Before Reform addressable of product size facts include XXXX. made option the therapeutic within Private indications, planned programs, potentially a future and I by and Act our our call expected candidates and and President Participating Mani Chalmers. we call Examples ongoing reach. development this and statements forward-looking results Dr. over timing the the the are statements will the begin, for future the Officer. now product Dr. Securities Dr. Litigation turn Chalmers, Chief of to you expected Cara that let forward-looking cash our Financial historical call me Mohindru, Derek our on our with CEO the are the of regarding the expected regulatory filings completion interactions of these

Derek Chalmers

on will CRXXX. peripheral expected upcoming programs for the us milestones. the the call highly was you, to as some summarize being thanks good us color Okay, trials productive development here more on for afternoon, we we Cara a Michael across significant continue everybody lead kappa then and through overall and progress, This at provide make walk that progress and agonist, thank quarter for afternoon today. our This with

trial and in associated made first trial FDA, quarter, Phase have Phase with shortly. of established the initiate support patients. are X the the an key completion End-of-Phase We our of plan in X treatment progress a as our including of moderate-to-severe in Overall, new FDA and this our X pruritus are associated kidney pleased particularly design pruritus program that CRXXX summarize XXXX kidney we before the the patients to consultation, currently pruritus there to by chronic program with with of hemodialysis for application pivotal is I meeting we no the the which now unmet need of This approved chronic drug efficacy CRXXX treatment general in will elements of the and end for and for course disease of have therapies the said disease, of we I.V. U.S. U.S. I.V. hemodialysis for the the

CKD that X moderate-to-severe patients Phase Stage plans pruritus. In stage kidney to planned XXXX. patients dose pleased X X for X trial oral recently our move CKD of Stage and CKD in oral to X pruritus use selection support CRXXX X diagnosed suffering treatment patients. chronic addition, general forward estimated to with earlier area, with CKD moderate-to-severe the X are in of XX% Current in pruritus from from in the inform the Phase associated this non-hemodialysis to patients those an trial X Stage of we in to which trial placebo-controlled CRXXX CDC are approximately the of of will QX in into associated CRXXX design of XX% to expand initiate plan disease Data indicate of very we CKD patients, to estimates

oral patients pruritus. X of encouraging I.V. with patients large has CRXXX with with potential hemodialysis stage to-date the a we earlier benefit meaningful to believe in proportion CRXXX the clinical observed Phase have bring CKD to we efficacy data, the moderate-to-severe Given pruritus,

pruritus are symptomatic targeting and quarter to treating nerve CRXXX see drug inhibition CRXXX later believe population associated second Phase enable relief initiation of the medical to to anti-inflammatory pruritus disease we a pruritic on CRXXX a we disease of conditions. is CKD has oral and X effects chronic In action an trial peripheral clinical liver addition chronic development the associated with that range to for pruritus, the that pruritus of year for for In this file plan based the this we IND dermal of potential treat combined liver across mechanism as we that associated regard, by end. this

returning moderate-to-severe our hemodialysis CKD of of timing two our conduct details CKD and AP. Phase to me year, patients. Based with CRXXX discussions on of placebo-controlled treatment program program FDA X and the and on the pruritus trials for the plan you lead let QX our we of I.V. elements for moderate-to-severe greater AP this provide CRXXX I.V. Now, X to Phase for planned some

in versus The first initiate and be dose planned the for X.X will randomized placebo-controlled trials numeric change at double-blind a second primary scheduled week placebo from a over trial end per half efficacy by the or I.V. scale. after administered year on to international average Both week as daily the is endpoint of the times rating XXXX three CRXXX in will treatment of trials pivotal evaluate scale dialysis planned sessions XX-week itch per first a trial to NRS micrograms U.S. measured the of intensity kilo XXXX. XX baseline worst The that period. is

Xb And coming with dose self-assessment per and of and life in XDH primary of as we CRXXX secondly employed to you in these using in And all endpoints. trials American Phase at of Xb continues is remember, aspects measure dose year, of New to X.X Phase This and of and I.V. employed and scales. part prior those Phase the microgram completed ongoing both scales both patients. progress is these on scales CRXXX X I.V. endpoint data regimen completed patients, a these the our trial. and trial itch previous of that completed we dosing design, primary per tools Secondary as Skindex-XX completed X the Xb endpoints trials dose, our this long-term trial reduction updating study HD initiated for are X Phase look pivotal trial the kilo quality Meeting of a each the program we Phase we patients X of presenting the in HD that Orleans. same successful this secondary from Also Phase Phase Nephrology’s the X.X trial life are QX validated microgram the previously for enroll one will the Overall, who much CRXXX met in a forward quality safety this of aside, quarters. you Society week over Annual safety the XX-week at of in an kilo

and Moving where XXXX. Phase expect away CLIN-XXXX and on enrollment we to from year trial, pain to by end complete pruritus our our adaptive postoperative early acute X program ongoing or

using X.X dosed in in three then post XX-hour undergoing per scale post-surgery. is through and on As of surgery hours the arm a reminder, various along up versus dose pre-specified is the curve, X second XXX area period measurement kilo The rating AUC pain intensity based in again CRXXX this time numeric Patients endpoint XX primary doses and hours at abdominal surgery. I.V. the collected XX patients the at over postoperative X, change trial microgram under the are testing receive a X surgeries. prior or to recovery placebo hour with a to XX and score points subsequent efficacy

postoperative assessment well being use of addition, post-surgical the pain. evaluated vomiting nausea endpoint of secondary global In as medication the rescue is patient and and also as as

updating said for in post-surgical these this in from you unmet we an in management look coming many and area we forward as of times on So, timing the months. trial pain need calls, readout remains the high setting the to

of within that Phase late-breaking with Additionally, week trial and and oral pain Diego. in as San next program, the Xb American College be from meeting osteoarthritis Rheumatology presenting our patients upcoming completed will occurs CRXXX’s the the of poster we in data

Mohindru So with Mani? will the for to financial summary, I call Mani on our that results. pass

Mani Mohindru

Thank you, Derek.

also financial closed. release issued the market after can our in reminder, the found our results today for press a third quarter As be

and expenses of in net loss a decrease period stock of was quarter for we per third The a XXXX, expense offset G&A the $X.XX XXXX. of the to clinical third to XXXX including million, of $XXX,XXX interest trial third the same the expenses XXXX. $X.X compensation $X.X the expense General primarily mainly reported third of R&D for professional or cost slight in revenue XXXX $XXX,XXX $X.XX third to option were quarter expense related of quarter $XX.X including same $XXX,XXX The option share period. XXXX $XXX,XXX compensation costs in of basic or compared of quarter or million balance personnel-related was to in XXXX compared for compared per the option compared loss third certain of stock million stock-based $XX.X net of and option third same administrative period expense million, the including quarter net We For XXXX stock-based expenses million of to income of stock no in diluted share are and including XXXX. on approximately to income $XXX,XXX diluted reported R&D the quarter million, a period to in due in higher and $X.X quarter increases in were decrease in of average $XX $X.X third XXXX our the of and direct XXXX the Other due by in costs. in basic fees. investments expenses in partly in personnel-related quarter dividend portfolio and increases increase XXXX. of stock million, of higher in

in marketable were September increase cash, the of to million cash, cash which and the operations million and securities million received of compared of December year-to-date. follow-on from exercise net $XX.X $XX.X from April The $X.X resulted $XXX XXXX. was at offset and options, marketable partially end As million proceeds of cash offering securities used XXXX, in from the primarily the by of XXXX equivalents XX, company’s in cash $XX.X equivalents million stock stock

disclosures. Our versus prior unchanged our financial guidance remains

and cash projected expenditure without We into expect fund continue clinical plans operating capital giving potential milestone cash, to requirements and marketable XXXX equivalents under existing expenses, any and existing payments effect development our trials including ongoing our collaborations. our to to securities

the to Q&A. the I operator back call Now, for will turn

Operator

Charles [Operator Thank from Our Duncan first Instructions] with comes you. Jaffray. Piper question

open. Your now line is

Sarah Weber

Hi, guys. Thanks Sarah for for taking my Charles. on questions. It’s

Just questions. two quick

design, can around the provide you Phase size and single trials? the these to us First then sites with X.X you of number you just remind and dose the can for forward micrograms on decided move color X why any of

Derek Chalmers

Yes. Hi, Sarah.

will you secondary being those questions, will the on those of the You the we Essentially of doses lowest. recall to ran in Phase Xb terms endpoints. three equivalent and our were primary X.X recall trial, of first in response all doses

forward made sense X.X. of was for it the the for us to move with dose moving minimal that So, forward the with rationale effect

latter terms going particular are Phase in the sites we the for that be trial, U.S. question, we X trial. to the recruit up In U.S. current of stock would that XX trial is the looking first the approximately to for

Sarah Weber

many Great. patients? And how

Derek Chalmers

more Based that current to per we to patients like initiate approximately size analysis, trial. Yes. we X Phase that on are precisely but actually that group, statistical looks going sample XXX get when

Sarah Weber

realize envision And any so X or should these we you about of liver then curious and disease in for now Phase efficiencies pruritus, meeting I’m just Thanks. separate Phase program? X development can associated great. and one just the follow-up, a the think clinical of you each plan as do non-hemodialysis here Okay,

Derek Chalmers

some most in and a patients relation to efficiencies to CKD question. later likely That’s patients also hemodialysis great are patients. of patients certainly and be some going We stage envisage those

We on our programs. oral are going to look

It’s efficiencies So exposures exposures. in in to different completely a in dataset be going a are to de chronic Phase see liver. to require X there we going going of there. novo That’s separate terms

Sarah Weber

you. Thank Great.

Derek Chalmers

Sarah. Thanks,

Operator

from with question Annabel Samimy comes Stifel. next Our

open. now is line Your

Annabel Samimy

for thanks question. Hi, my taking

interval talk looking to am can powering and on you the are you arm of about size the yet, this of about trial confidence and at size in a are trial back in sure I are placebo but the if Just terms at? looking XXX in you per us difference talk the terms for to position or you what not the exactly

Derek Chalmers

of start data dosages. that, that in three on can’t our across to Obviously, Annabel. Phase analysis And power will into at going X is see I go we have terms all I the great when seen size you based accurate Yes, in you the sample are detail trial. more leave our that numbers it the

Annabel Samimy

compromised Okay. to like or is for in And healthy initiating population that in renally X in as far as to that be you going be the CKD is going oral, volunteers are specifically? Phase that the the patients

Derek Chalmers

Stage and No, patients that’s to patients compromise X stage X going to pre-dialysis. be renally the are X

Annabel Samimy

Okay.

that’s the that already Phase I guess So, you am doing you the a X. oral in guess formulation as are dose you you opposed Phase I in have curious just why Phase wouldn’t given why start in finding dose, an X are Phase X X? had into I

Derek Chalmers

great It’s the And you, there a the CRXXX excluded renal. question. for slippage been molecule, a to in PK entirely terms in is has just here the remind case for of our

various renal precisely And so PK it’s stages the we for these designed very important of function.

condition that same give the of precise in each numbers forward patients to have the of take which we we we to renal are function. and then and exposures be match then can HD efficacy course for stages of sure So, the to confident us those dose picking correct make exposure compromised want we

Annabel Samimy

I pursue when you IV change great. can Are data oral? trial on to this but potentially trial question development about out next pain, are or in initially dose just Okay, the waiting the I data ask came the And you how might before in further for the when thinking you oral about haven’t to pursue that in talked noticed if oral? the to you continue really readout I any modify CRXXX the pursue the in the you know could pain, a program you

Derek Chalmers

those see with some I get those, we different we know the two for are aspects looking but those of at OA like I really the Yes, people are linked. link as to drug CRXXX. anti-inflammatory really we effect think data

afternoon, would do to we said of a data our I out Academy forward as the minute a continue move of partner believe could ideally Rheumatology with to consult with that as be like that there, we are also KOLs. And with analyze indicate the we we signal going be do original and the of in the there that help So with from as hemodialysis aspect X patient are We group. currently, are finishing dug off really we is X that and idea as could you that think the CKD near-term particular partner moving forward post-op start the within into this cost call next American at could I us for the focused and At our presenting the program. board, Phase Phase week on to particularly, that. of you program exploring appreciate

aspects are we that and trial. considering would OA board with partner help come a expenditure ideally So, on see next on still the for like the to

Annabel Samimy

thanks. it, Okay, great. Got

Derek Chalmers

Thanks, Annabel.

Operator

comes Our from with next question Canaccord. Arlinda Lee

open. now is line Your

Arlinda Lee

Thanks guys. really question. questions. taking Hi, for had my two I clarification

Phase population Phase formulations oral to the and you X X are that on Phase going they starting the a So, be separate that are X, the for correct? is

Derek Chalmers

Yes.

not are in to who patients moderate-to-severe So, X the are CKD Stage X necessarily patients. for Phase X pruritic

The an within are X population function also who moderate-to-severe to identifies will Stage that entry that that defined renal patients. in those X CKD those X have range Phase pruritus. patients by criteria So, have

Arlinda Lee

able you exposure And number the number to great. Okay, patients appropriate to Phase or if the of formulation XXX does of and have to each be that for U.S. patients then and appropriate the ex-U.S. get IV X the you the – for file?

Derek Chalmers

equation. for months. part Yes, X,XXX program, we the exposures X and with to the appropriate planning guidance at that’s year level minute, the that At there with exposure standard are X

to certainly are of us number. total get part that plan So, to those the

Arlinda Lee

great. Okay

Derek Chalmers

Arlinda. Thanks,

Arlinda Lee

of the the different impact two ex-U.S. the care differences The last trials? you that versus U.S. in any that question expect outcomes is, Thanks. standard might is in there

Derek Chalmers

so. don’t We think

certainly international a possibly and you to other, are Canada, our planning include we populations we are We type Western looking have at component European trial, Australia. if like, possibly there,

So, is standard that of pretty across care uniform.

Arlinda Lee

great. Thanks very much. Okay,

Derek Chalmers

Arlinda. Thanks,

Operator

Thank you.

from Our from comes Janney. next question Ken Trbovich

Your line open. is now

Ken Trbovich

sites the we seems timing anything whether have enrolling I I am from the there centers done know standpoint you you previously? a been had have they studies Is trial with running. studies these it like it that Derek, got certainly hear have studies about Thanks. the to visibility have and you once differs on to have results excellent are of to the curious regard and starting guys that in or relates involved the from up as either you XX of that prior done nature kind

Derek Chalmers

Yes.

Some – hi, the are of thanks them questions. Ken, for

used Some increase size as of about across them trial the remember, have trials, previous been sites is our involved number obviously novo a active XX large but for the last lot of a in this U.S. de trial. in you

are of a de we on bringing is there lot sites no So, board.

in very recruit some reasons Julia a We and of meeting, I old she of is don’t efficiently and trial, have new that and trial. the of careful new sites sites particular PIs been looking from can road so the site new this selection today, for last the one for our have the on lot sites

Ken Trbovich

am time to as coming is of a a sense get what a too data to but before study unreasonable trying reasonable us next the for the on, am look the than got bunch it just sites, new is I that we to reason of in and maybe year look last at to be early horizon a much of have the that of last sort year, difference, enroll started of this there just I I these the to if a expect of year? X-month for Is you it’s know there middle more expectation? aggressive I rapid back of completed same double got centers from it been end study, sort and for historically have part But at was any the

Derek Chalmers

number say efficiencies Ken. within as terms heterogeneous know, of with the I the patients the you sites on the of in are in they trial. very understand very really Yes, of issue clinical their the terms these both The question,

as very it’s difficult trial enrollment So, until predict to the get we to underway rates.

for guide I X sites as Phase that how will guide we year then to once sites we doubled are prefer to to are rates X approximately particular trial versus as you see get across and whole have the early kicked we next So, Xb. the can Phase recruitment off for endpoints the of the use correct to we going we that range we would this we trial, see Phase and but the

Ken Trbovich

if studies, at question a it and process? these at you types And it when for role does market from service it help, does thought begin Okay. comes the the then of hurt, of sort does looking last just all to in major these providers guys the you standpoint background dialysis as commercial provide a it

Derek Chalmers

Yes.

would in think those I and clinical both that in of so involved work here impossible run recruitment. it we with trial the or of the groups, terms Fresenius U.S. we be with exposure that DaVita its to either in canon maximum get

Ken Trbovich

you. Thank terrific. Okay,

Derek Chalmers

Ken. Thanks,

Operator

comes with last Our Brisebois from question Francois Laidlaw.

is Your now line open.

Francois Brisebois

Thanks for taking the question.

a quick of here. ones Just couple

pain for CRXXX, quarter, the still in maybe of ‘XX? expecting data first be kind on the side ‘XX So a enrollment more first fourth first it is or we quarter I.V. half quarter should of

Derek Chalmers

the months Yes, happened had Thank for a you in the we’ve hurricanes sites the major Florida. some of hi that’s Francois. Southern yes, lost U.S. you we’ve the and way last both know couple call. at Texas in of And and as unfortunately couple so

we which we but why get recruitment data you bit may report for going quickly out we then that we in can and slip into So trial, slowing are can’t ‘XX, there recruit year. up as particular enrolled think as to quickly a bit a is our hasn’t as next of little been fully as little

Francois Brisebois

link pain. And heard oral much and see, Okay, then I here mentioned lastly, I for not is between you IV great. there

and of still KOLs whether knee any is of that that idea it thought misunderstood the the leaders of might OA other? you versus at is [indiscernible] in the there happen data, looked had not the the it’s pain, like would why As have difference kind working and any one hip or kind

Derek Chalmers

and a question something across great consistently obviously with that’s No, us KOLs.

between in in cartilage previously last target of knees that know the has response has paradoxically tend and from we’ve response as been two been and a one the the been kappa in as there conversation than heterogeneity degenerate and terms we’ve difference the hips before the joints said cartilage. think the that of hasn’t it’s for explanation on call the rheumatologists seen the you right that between joints agonist faster I NSAIDs to is not to

again possible between So that’s duration and as joints patient use faster to continue Xb populations trial. is disease the Phase that population as of knee we these something And in that that explanation do than target looking hip. two one in we lose analyze we we’re

explanation So that to difference the the has joints. as one two possible between

Francois Brisebois

you. Okay. it That’s from me. great. That’s Very helpful. Thank

Derek Chalmers

Thanks, Francois.

Operator

question another Ken from have Trbovich Janney. with We

line now open. is Your

Ken Trbovich

didn’t I Hi, so Mani, off you want to let easy.

little know maybe the ask So I’d significant explain sequential pretty talk year-over-year, I jump? I like don’t G&A in figured if you but about to mind sequential the you seems bit increase the a

Mani Mohindru

Yes.

was one-time Cara to there that and of So, at $XXX,XXX being and a over related related like approximately stock related CFO, is of option who decade. after that retired expense a prior for the expense is departure

is one-time forward. going that that we a don’t anticipate So expense

Derek Chalmers

Yes don’t I but [Indiscernible] know a have in and Ken, still read to that a time there. it, it’s you

Ken Trbovich

read the in to between call. it the hard call, release Yes, of the press the XX the release in minutes Okay.

you. Thank appreciate I the color. So

Derek Chalmers

Ken. Yes. Thanks,

Mani Mohindru

Thanks.

Operator

at I team the any am the to call questions back Cara would any I time. over this turn not remarks. further showing further now from to like

Derek Chalmers

I look to to with you like their patients our who the very thank call. team would of Okay, Thank thank and progress you to families support our for various also importantly for and and participating time, like in the forward participate updating And today’s everybody soon. Cara I work would investigators also thank you we trials. the our continue everybody. programs. hard their thank to and call. you that, conclude I at support continued And this our And to most

Operator

your today’s Ladies participation. and again you once program. concludes for this Thank gentlemen,

You may all great disconnect. now Everyone, have day. a

Cara Therapeutics (CARA) 2 Nov 172017 Q3 Earnings call transcript