CARA - Earnings call transcript Q4 2018

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Operator

Good afternoon, and welcome to Cara Therapeutics' Fourth Quarter and Full-Year 2018 Financial Results Conference Call. All participants are now in listen-only mode. There will be a question-and-answer session at the end. 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. proceed. Please

Jane Urheim

The is Therapeutics' Stern XXXX today Fourth and Conference this welcome Relations, Financial and Urheim available Update Cara became on to Quarter Call. at can Jane be afternoon, X our Investor with and Results just found Good after release website p.m. www.caratherapeutics.com. news and Full-Year

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

turn expected matters Securities made Before are on we Mohindru, the be Officer CEO; ongoing call remind the me facts Securities include: Cara today's candidates; with and over in Dr. its the and subsequently therapeutic timing and cash Dr. forward-looking in Form the risks clinical Derek and our not Commission, expected Examples Annual that begin, Company’s XX-K Therapeutics’ milestones clinical now the Chalmers, our reach. planned Act implied statements regarding are you or Exchange to and the from fully that section results historical addressable of those are the expected and filings on our such by Officer. Risks potentially statements results to to XXXX. and of future product XX, and Dr. expressed with this multiple on meaning Factors” product December call Securities statements including such these for year are markets Because Cara of indications; Litigation let are XXXX statements our filed and completion size our by candidates; of CRXXX documents of I'll for the Strategy subject a may Financial of Mani call ended statements forward-looking trials; trials; Exchange announcement more Report to concerning described and for or Chalmers. Chief of of design actual the within uncertainties, regulatory differ the materially Reform the Chief development “Risk the that Commission. Private and Participating forward-looking the the President option furnished other are pruritus statements. potential timing the of

Derek Chalmers

a afternoon, XXXX Good the of candidate our certainly of joining significant a Jane. offering. for advancement for KORSUVA Vifor drug agreement of across signing clinical us licensing a at where the you, of on strategic an the unmet pruritus range Fresenius a need. and call everybody, Cara, thanks with is follow-on populations was $XX Thank important million achievement us here completion of today. and including significant successful lead year The

Injection for disease this trial So KORSUVA with Phase this well year. has year the certainly year, the we initiation from half second this chronic pivotal the III designated of data had remain to of groundwork year our clinical be for Phase the CKD-aP expanded our hemodialysis associated corporate III progress of a program company. will pruritus or In what laid transformative we XXXX, two and believe kidney in ahead KALM-X for in of January of from we In as the and completed second enrollment on and the readout topline this track we we this topline KALM-X KALM-X as trials, announced in of trial KALM-X. data quarter patients

second topline III-V in Oral patients the CKD half Our stage XXXX. of data ongoing is predialysis here of moderate-to-severe Phase II expected trial enrolling with with KORSUVA pruritus

proof-of-concept dermatitis quarter this II in Oral middle a Phase moderate-to-severe the initiate I pruritus of KORSUVA of second initiating pharmacokinetic and year. we lastly, atopic of safety or in Phase to following in disease CLD-aP plan completion Oral the with pruritus then also We anticipate of And with multidose patients trial. around trial a our KORSUVA recent the liver chronic Phase trial patients associated II

patient are we well positioned KORSUVA program XXXX. as on across overall, progress our for patients multiple lead HD Oral in execute well program as Phase pivotal CKD-aP our populations to in III So

So like profile cells. fibers. on as we potential sensory I'll dermal chronic conditions. novel action KORSUVA of and the dual on some first its the liver call anti-inflammatory you broad an today, traditional its initiating stimulation I'd action receptor on chemical release due mediated to cells regardless as our clinical and to a of receptors side [indiscernible] programs, course, on provide anti-pruritic kappa its by dermal effects range affords agonist KORSUVA’s opioid that's that the or which The agent specific disease nerve-sensitizing And peripheral diminishing of of remind believe briefly on and function effect underlies KORSUVA effect dermatological structure. well kappa is kappa mechanism these dysfunction. more epidermal peripherally-acting action of receptors to first-in-class KORSUVA's across KORSUVA each pharmacological designed is, sensory a afferents of certain neuronal immune detail whether of we the act anti-pruritic of kidney of selective chronic as on to or immune opioid molecules without blocks of highly action of believe disease, sort pathophysiology, but

like in I'd with of to start Injection updates on So program hemodialysis patients lead CKD-aP. with our KORSUVA

the sample for calculating enrolling the ongoing size the an its IDMC, not assessment we and efficacy to targeted on program As rule KALM-X we global this further analysis the adjust maintain between study, to of the efficacy recommendation of power the power, did three the pre-specified announced trial, indicates in the enrollment consistent that power desired recently both a a trial XX% completion trial, in study. conditional extension an after assumptions the currently the III used Data and the groups, IDMC’s KALM-X KALM-X brief Injection review of conditional are power the achievement outcome this when completed patients of reminder, the was or XX-week began this Based population Phase analysis, to of treatment late-stage Independent We And and pre-specified the period. observed size on open-label Committee safety of and the KORSUVA for trial. patient includes patient the full KALM-X both approximately results and studies, XX-week first and The interim Monitoring U.S. a we the a statistical sample XXXX of difference clinical this KALM-X. clarify detect at results decision III the made based trial. planned Phase interim IA recommendation conducted with the of the formula number given regarding on

quarter. and recommendation, data the topline to track completed Following enrollment approximately we're we from IDMC XXX on in trial readout in KALM-X second patients the of this

pivotal the a period interim completed pre-specified after and again also of approximately analysis with look is KALM-X, XX% of Our designed to assessment forward trial patients this providing result similarly KALM-X we to a second of the of investigate in expected at topline KORSUVA which Injection micrograms half the versus data, of KALM-X the per of second designed to ahead KALM-X placebo. kilo efficacy XXXX. X.X is Both are dose and treatment

Numeric times score of You scheduled or improvement with will treatment the as Scale recall XX-week baseline efficacy itching daily NRS. per three a intensity weekly as sessions week-XX respect mean period. at to point patients least endpoint from primary standard week over Rating after the a a The dialysis achieving on of three a administered measured worst at proportion

self-assessment trial. in implied we X-D scales, IIb itch, the using the of and measure itch-related which completed Secondary Skindex-XX endpoints quality aspects trials Phase the in our of validated life

include than patients improvement weekly itching Additional of and the point secondary XX-hour scores worst the week-XX. four from achieving endpoints of the proportion a mean baseline daily greater at

II XXX that extension level. We study, these patients. open-label To-date, have XX-week have past months treatments Phase and and track closed for been goal there treatments. pivotal and developing currently a topline patients KORSUVA in program the toward of study one-year completed our remain Injection ongoing have observed first-in-class designed moderate-to-severe Injection hemodialysis III new hemodialysis year, KORSUVA with a reported exposure which for Phase safety XXX through patients recently trial in the an no of evaluate safety is patients third KALM-X about of the The trials Injection and With Independent FDA-approved up signals Monitoring with evaluation, study. KALM-X been this and this based therapeutic KORSUVA suffering Safety from both enrollment a XX% the as consistent on data pruritus, approximately safety expected on to full of of from in no patients data Board six breakthrough, in Data tolerability in are to now we

estimated advancing were generic the there focused moderate-to-severe We generic U.S. is X.X being also on script from patients with of care III-V million on in with patients suffering Based pruritus-related Oral corticosteroids current CKD KORSUVA antihistamines. Stage that standard predominantly numbers and remained pruritus approximately for predialysis CKD-aP.

to This months on our daily. of which randomized the who with KORSUVA In multi-center mg to KORSUVA, completed U.S. impairment, providing we with Phase Phase trial, dose CKD-aP in evaluate both evaluating X.X second and designed enrollment equivalent X.X is the arm. in trial. endpoints allows level currently doses strengths tablet of an expect for From coming kilo we were non-dialysis half effects it Phase assessment this enrollment expansion treatment Injection those tablet, with is you approximately are I on administered XX% interim patients, in data a year. X trial and double-blind mg moderate-to-severe trial in significant trial HD II renal KORSUVA these Oral assessment dose power the exposure look of Oral We tablet patients. the track which that the currently achieves of a II three enroll XXX per a unblinded at our interim study patient placebo-controlled patients. Oral weeks have tablet an update safety KORSUVA, patients completed secondary efficacy to ultimately XX up provided in the once providing an topline determined that is we statistically patients and Oral ongoing CKD XXX trial of to of primary This per for XX of with There milligram the to achieved forward trial in XX-week and and levels Phase and microgram KORSUVA X.XX this IIb those

data, patients trial Lastly, we quarter liver KORSUVA, chronic Phase dose-proportional I forward in strengths Oral multiple disease initiate additional may a trials chronic KORSUVA Based pruritic second parameters disease. this signals of move benefit unexpected trial both with associated-pruritus were recently from presently pruritus Oral The the tolerated that on year. populations as with II completed in a of associated safety and this are We've reported. with and KORSUVA to liver to Phase dermatitis. at planning no II patient was generally atopic initiate we Oral well in expect tablet Phase we pharmacokinetic with

year this and expect atopic to look details updating dermatitis proof-of-concept also the a around II trial forward middle have initiate to We we and on this Phase underway. KORSUVA of Oral when patients of you we of it the trial

with expanded have to overall, look readout call year to providing coming expected turn trials a our now Mani? an forward very updates I'll that, for and programs with pipeline So we results. development will additional us significant pruritic multiple we of here Mani, populations and in progress to these late-stage financial who months. ongoing discuss all the of across And the over ahead

Mani Mohindru

Derek. you, Thank

reminder, full results full-year market the can issued today a press and for XXXX As the our in after be fourth financial the release found quarter closed.

or basic of XXXX, for net share we share, reported or ended per of loss per loss and diluted a $XX full-year basic the $XX.X $X.XX a XXXX. and million, million, December to XX, diluted net compared For $X.XX

as quarter the of Revenues million diluted $XXX,XXX share a December basic license for Kissei of XXXX XXXX in year also we versus sale share and in For per XXXX XXXX. $XX.X as related compared $XX,XXX were ended million or diluted compared XX, for a agreement loss the in XXXX. reported sub-license Pharma. clinical in fee XXXX to and connection of compound $XX,XXX $X.XX a from Revenues $X.XX revenues in with in primarily net our Maruishi fourth of sub-license revenue basic in Vifor million $XX.X to $XXX,XXX Fresenius to partner agreement loss Revenues our to compared related of or compound Maruishi to to per clinical same $XX.X received with Pharmaceuticals included from of net were its XXXX. the quarter with XXXX,

million related related increase collaboration We quarter expenses. expenses revenues Vifor the we during $X.X the December $XX.X not as For in Research $XX.X ended any million for primarily compensation XXXX did payroll stock in the of of XXXX. and XX, recognized quarter million as year fourth fourth of Fresenius due XXXX, the clinical agreement. trial costs and higher the recognize XXXX. increase The development XXXX expenses were compared revenue were well to R&D in to as in to

$XX.X costs. in in in increase reported higher due million and to compared G&A and R&D related G&A period same of fourth rent for and $XX.X trial income compared million XXXX, period. quarter, expenses by period period $XXX,XXX stock primarily income $XX.X was quarter partially again $X.X higher XXXX for year. was and in XXXX, XXXX fourth Other in million compared the $X.X XXXX, of the cost. expenses $X in in $XX.X payroll XXXX. increased to compared increase The consultant million in due million related the was in to as $X.X million to fourth personnel same expenses in million XXXX, related investments expenses, the of same million XXXX, clinical prior of $X compared of The this expense of mainly of were million and the due to the offset to quarter Other XXXX. we full-year For of General of to compensation administrative during decreased the XXXX. to balance

December The $XX.X an the which million options. from to from primarily of of in million investment company’s at of upfront compared of net proceeds related agreement $XX of million Vifor of end $XX included July, cash of to totaled license Fresenius, and proceeds premium exercise the million in at increase the $XX million with XXXX. stock equity and XX, payment $XX.X $XXX.X resulted proceeds XXXX, cash, from As offering cash follow-on million our equivalents the

to financial operating to collaborations. expectations, XXXX XX, current costs of capital taking our under expenses any into call now cash Turning fund for Q&A. XXXX timing to plans the the back existing projected guidance. Based and requirements the turn I’ll we cash, as expect operator clinical without of that and our on account our development equivalence will December potential our expenditure sufficient into milestones be

Operator

question from Howerton Chris [Operator Jefferies. from is Instructions] And first our

open. now is line Your

Christopher Howerton

congrats and the the all thanks Well, and Great. taking for on progress, the question. quarter

contextualize be I you that my been. helping have I but helpful described other the earlier think, the potential Derek, the main this the was know outcomes would I it interim just year. that what from to at that side analysis analysis, the kind might process, question maybe of performed better understand is, powering have least

you to alternative us that? triggered they that size. increase you outcomes could sample – been? would could you What didn’t help So the understand have say let's the needed have say And what maybe

Derek Chalmers

of that. Yes, Chris. standard in that sure. Hi, a so Thanks. Thanks up type for Yes, that was really for set analysis. way

study. So what the see sample to statistical their desired in to in power as calculate the the to difference size two IDMC the relation between advice by was required sample that size. a we a And graded possible groups maintain ask to

the sample to than possibility IDMC analysis correct groups. size required to see to of the were our full possibility a groups increase terms made was level difference the was And there or for or us maintain our fashion. size was the size power in in maintain unblinded of sample two XXX, that odds specific based runs is was a an maximum which a And desired a tells we two to between high to it IIb there study, advice effect sample again or the And size the y, that size evidently the to a not to in observed this ratio on Phase IDMC. that that assumptions to of between the what received a and power power, remember, maintain maintained. was which course So increase up difference was sample as which less x, was to to increase the

analysis So maintain a their maintaining and to threshold power their really of is a difference. statistical modeling what

Christopher Howerton

Okay.

you sufficient So essentially effect powering they powering the observed the meet assumptions a initial when that or enable to trial? had you designed

Derek Chalmers

Correct.

Christopher Howerton

Okay.

Derek Chalmers

set level. we'd threshold level conservative obviously or high And a that at

Christopher Howerton

Great.

pharmacokinetics of and data Okay. there And was chronic I present described any in are Phase there then the unexpected, plans the to for you I kind that know full more disease way? a liver the nothing those safety trial,

Derek Chalmers

data initiate and a actually maintain chronic to fashion exposure you're dose again would hemodialysis that Phase disease an some efficacious we present we've going the the some the population. wanted in data going II is overall similar that in PK kidney we're see to summary Phase where essentially I, exposure when to match There we trial, overall to used patient

going initiate you're to data fashion Phase So see summary in that II. we when the

Christopher Howerton

just maybe may. Okay. if I sense. last That one And makes then question,

terms any population I us going, and with target you trial, that mentioned The atopic patient that? think one. more For you can is we'll see planning trial about in preview give the but dermatitis of to information that up actually you're some what

Derek Chalmers

we to the moderate-to-severe. pathophysiology. within the to be look and both of of both Yes, obviously there at in inclusion the those And breadths will related are population mild-to-moderate at be terms pruritus going populations. looking patient We'll criteria moderate-to-severe

Christopher Howerton

Okay, thanks I questions all congrats Well, hop queue. appreciate the for and and in right. back I'll taking it. again the

Derek Chalmers

Chris. Thanks,

Operator

you. Thank

Gerberry from next Bank Our from is Jason of America. question

Your is line now open.

Jason Gerberry

I my for a pathway III talk wasn't for III-V trial CKD of about evening. in the in weren't size framing about effect – indication. that good little for the postoperative the you what think XXX. Have Hey, maybe taking secondly, I for bit just Thanks some potentially group? And PONV meaningful – first there – on I more you about then how you we clinically can is a of KORSUVA can Oral think about group, talk just when you a Phase kind sounds FDA regarding It like just the there interactions? exactly, question discussions guess know had was sure applications any questions. just recent

Derek Chalmers

safety our to the To exposures post-op if clarity the would path label change in Yes, get to both thanks program regulatory we'll particular on existing we and on there the relation regulatory initiate into certainly from that provide. and agency to as more some have fit on on when is the there next those we already and that's possible will we Jason. detail that exposures the something first PONV, aim of And trial PONV gauge path.

measuring CKD mean oral, those baseline significance. worst we statistical looking differences scores. usual the in itching meaningful NRS already don't On terms clinically be terms simply related main established This on don't where in the CKD-aP at sizes, will of differences. to up and and obviously There that size those from and hemodialysis patients. at we pre-specify with KORSUVA changes set really observed with scales is we is in But pre-specify we've populations, That's sizes. and to differences. We of related sample you're effects based modeled model we effect getting the on on

Jason Gerberry

Got you. Thank it.

Derek Chalmers

Jason. Thanks,

Operator

you. Thank

Our next from question Piper Amsellem is from David Jaffray.

now Your line is open.

David Amsellem

Thanks.

a questions year. atopic to this the had planning initiate later I you're about couple So that study of derm

to the and – on or not So And itch, – be four to wants? is doses at analysis conditions going atopic differ derm just point responder may other have the for a dermatologic other worst that in FDA help us understand, you're the are and or three the analysis then responder measure outcome responder secondly Thanks. given anti-pruritic, point how color four in programs? a be least the dosing a at doses evaluating on your may something that that what CKD seems analysis, program, CLD and the on the point that primary looking expectations from any

Derek Chalmers

of endpoint for as And and David. the each these question before patient in appropriate a Yes. of that's Thanks, populations. this we've know, terms you great discussed

relation population So in the was that we analysis reached in based on for empirical a on collaboration something breakthrough look And associated we really hemodialysis the pruritus endpoint the FDA. application. with to was

a we their those clinically that around correlating data worst from and meaningful Phase would and life was particular number derived that's patients. the significant NRS with underway. would and scores taken bumped up that for III And clinically what scores we X scale somewhere change meaningful from the an of to of patients that's we derived trial that change where quality in what be that see a impression in on we ended and we the itch X.X patient and empirically So differences be

are the analysis but reduction, dermatological that looking clinical a this based There within within psoriatic has dogma. populations You population been point a at dogma performed a correct. four meaningfulness, on an really was for only nevertheless

mean population in as level of well plan change into our AD baseline. that KORSUVA from indeed reduction moving So at to Oral the look as as

in four we're the move discussion will to when CKD And FDA point, the still the associated continuing population. we with we at the point dermatological which looking again have So be three empirically we for with population. derived

David Amsellem

AD then color dosing, any the on for And study? dosing

Derek Chalmers

We'll AD very we of guide we that's the a trial, when day with course healthy have unlike initiate likely population, renal that with be population function. to twice to dosing generally a Yes. the CKD because healthy

population, trial BID to and So that's a in the guide we'll start when likely to be regimen dosing the there. we that dose

David Amsellem

Thanks, Derek. Okay.

Derek Chalmers

Thanks, David.

Operator

you. Thank

Our Duncan Fitzgerald. is Cantor from next Charles question from

Your line now is open.

Charles Duncan

kind of us question quick KALM-X, and criteria good you a that guys. compare also you the out Hi of same and coming on blinded enrolled patients very analysis the look my congrats year in or a exactly basis Thanks one is KALM-X. being for to in like a the up. had Can interim KALM-X on does KALM-X? how when tell different, Couple taking looks It interesting questions, pretty you of progress. nicely, laid

Derek Chalmers

because can't a basis give of sort Charles, look one, the blinded one I to last any at. the Yes. ask no to data answer me on will

difference have they and we look is the a see just that KALM-X. is which groups blinded. conservative statistical at we the XX-week to I treatment And going that the talked in terms when of about the two But setup KALM-X IDMC power, of look we We're in is trial. level be with analysis. the the to of of complete going the between same as routinely. for So conditional same same remain the don't a exactly as Again, as assessment, design maintain to at look The power unblinded Chris to XX% patients interim period. that pre-specified

performed treatment going it's the the the XX% So completing same patients be at period. to XX-week It's designed way. of

Charles Duncan

helpful. Okay, that's

basis. let new How data – don't an about they unblinded blinded or on So unblinded? an you

Derek Chalmers

to that's about Well, Charles. yes, end horrible trial, get Yes, it, there. at life the out I the a of see. It’s

Charles Duncan

great. Okay,

So also call I'll KALM-X, what know don't you KALM, the on extension it. study, call XX-week it I

And continue of gotten months terms patients look on infused then regimen mentioned have qualitative the certain in they XX call concomitant are six number at means how I through other, is and doing getting the guess You modes of any that how of those on and drug they patients dialysis. that And are in months. or it – doing time? over

Derek Chalmers

other trial, same no as that best you're measurements than drug There's are exactly then patients to commercially. be safety. exactly used Yes. in in those particular trials is Phase correct, Charles, we our same But the other for manner dosed that going manner III the and use

three because sessions. to excreted, the the anti-pruritic that's next just activity. get you times two the this remind depo renally a exposure And So level post-dialysis, week for drugs which we post-dialysis maintains days

Board one-year the had there that best Data Independent trial was we've one week a and exactly So up completed within no to we regular XXX said all. that times we three today up same unexpected And I'd and on XX% quarter six-month group and and What through patients approximately one-year. mark is, manner safety at dosed of about just through those are are the in they Safety signals for mark. have that are as analysis the Monitoring

Charles Duncan

couple non-KORSUVA and a or through And looked the KORSUVA chemical Okay. last there's IP last The on it's a, quick just into can help That's because the of extend not that then since of new to I a IP? years helpful. other a IP couple this. whether then been other ones, when us it molecules around call you fence picket on understand may

Derek Chalmers

Yes.

about U.S. course, a not but patents, presume matter I without asking there's dozen no should runs including patents to of about there patents. issued U.S. patent worldwide, XXXX and filed that composition we So extension. what you're of so is – dozen is issued

five to the So that years XXXX. goes with

Beyond is one. that, normal our strategy patent the

related some we run on. where that mid-XXXXs molecule. be also the have formulation working obviously that used beyond We And using in patents have those we're patents fact, then and around would into the

of, So around I feel there is number the sequences. fences like a

anyone terms difficult unlike break, is organics much that's of Charles. in In manipulating likelihood small chemistry of where to terms the more rings sequence with those of patents, around heterocyclic possible more these breaking peptide much

sequences So we've that's and tetropeptide as kappa affinity think we that have know, the we receptors. those actually of – a the ago you our specifically tested number to course years relation and for claim And secured empirically primary patents. most of area high of entire this on the

can specifically difficult we quite patent, very So tetropeptide entire sequence terms to in and break that we of controlled kappa sequences well have the so receptors. think a that interact with opioid

Charles Duncan

hear versus And last question if David's relative mechanisms? mechanism that antagonist. the antagonist in but opioid related to of activity mechanism. MKX to the – on on fair MKX merits I perspective two derm terms you've to perspective wondering I'm of [indiscernible], derm. question atopic pruritus your kappa agonists a atopic with on going back love There's have associated you with know of amount

Derek Chalmers

Yes. opportunity. Well, big a it's

in everybody there's certainly and a think it's need room for that I patient unmet population. significant

And endogenous view, is control system opioid locally for severe mechanism used important think physiology in when us most that my it – antagonist the far the of of and the pruritus. animal and very comes drug a is pruritus a a the industry uses injection one to as is mechanism fairly we've indication of models produce view potent by Our agonism how with the know, and for couple and to development this important is in therapeutics. now done that GPCR as and the animals, agrees years of a I the human kappa which you an system is I've

is which driving that in amplifying, we're And have more situation. to much system antagonize it's especially I so think we a nice, always and that difficult

main we're so far So of proven we be systems tapped into and one that's correct. think driving to the

across regardless associated from effect disease models, and clinical of the drug liver data kidney both chronic at all and mechanism in and our Japanese efficacy we mechanism seeing we the know chronic pruritus. with certainly animal we're As disease that look data some other

anti-pruritic broad applicability, but So far that to be would empirically. we're test the the data going

months answer this. stay to So going all of and for about we're have the tuned to XX

Charles Duncan

Reminder Okay, very agonist pharmacology Thanks one-on-one statements. helpful. questions. my of good, with taking for

Derek Chalmers

Thanks, Charles.

Operator

Thank you.

is Samimy question from next from Our Annabel Stifel.

now open. is line Your

Annabel Samimy

taking Thanks question. for Hi. my

go then for the to want might adverse back watch effects CLD any the population. have Just to any to population complexity of their in particular you disease, given event Are side that there out this particular expect trial? regard do dose to at the to the And have we similar any you're Thanks. the of already in with should problems? size you what sense CKD? of looking proportionality, And something

Derek Chalmers

of one chemical is advantage a of on enzymes or have any Hi, you we remember have stimulator metabolism with Yes, of the interaction the Annabel. any we substrate Thank class test or as having of inhibitor. every performed CYP course, this don't and this either so possible you. any liver don't

So specific but predict. have of rightly We'd you as point a with issues out, patient there's population, we lot comorbidities there. didn't in

what exclusively as between know the to function twice that data. we this significant KORSUVA ensure a to going I renal fact have So some urine. we've that the strengths of and be diminishment and to level we efficacious excreted excretion patients CKD us some saw as and liver going the do via give empirically be, we're said to wanted dosing we not attain you that could are is the that to levels of almost XXX and a is going exposure were CKD day. going to was Oral inhibition that knew on match Despite earlier, select going is that was, the our we we done there. tablets to And that We're it based difference

was to the And so we that establish and make that wanted sure case.

we don't which to is in see trial, different likely seen going the to we're other in be very similar we’re So The that - CKD the population, dosages that And using V tablet that start particular safety good, we that anything a range to can in III announce when strengths dosaging. patients. being we populations. to again once-a-day we'll there use we've twice-a-day the in there, than be deference looks dose Stage going just

Annabel Samimy

much kidney larger, us CKD on is CLD Stage Is And mentioned CLD, it you is - about you give has sized sense Just Okay. smaller? there? X.X the opportunity can V just chronic so III similarly a disease. that in

Derek Chalmers

at with fashion, rather epidemiological liver. That's a and are stays the using with codes a various numbers we associated moderate-to-severe script that Various ICD-X liver across question. pruritus. the good numbers in looked also Yes. that at conditions similar looking in disease Again, than

similar all addressable those terms patient all around situations we somewhat and is Biliary U.S. also the up it course, a nash look the liver then add known, has we at course, atopic, know Of scripts those and a course, hep-B in And up, pruritus. of to of all population. some magnitude of looks in that's of the of can couple conditions, this when from infections which there, we Cholangitis look with add get somewhere million been data, as viral opportunity that's that and so pretty CKD a then And in potential population those predialysis of disease recent patients, but to some year. best Primary And the when a severe like of cirrhosis there significant you patients. opportunity. different you associated hep-C, When medications at when some

Annabel Samimy

a pruritic we're the Is treat it's difficult Great. itchings program help I then while pruritic that atopic disease on other a can anything dermatitis topic, mean, that you shortcomings, there your from any better to might condition. with Okay. or – elusive are apply you learn or failures to are that a And trial any can from – there been outcome? from perspective, there trial

Derek Chalmers

the and use to of that all of pruritus contrast effect had dermatological those those most really KORSUVA uses shown selective there of tested great at kappa select a or in of reality agonism. sort But acting models. the certainly Yes, through been been of Annabel, of peripherally in the end certainly we and in been day, mechanisms another, Everything and has terms of hasn't I used industry other in think models are we in today less population. partial some the that one that's

in yet as and patients hasn't feel population test be careful an select appropriate patient coming that we we'll into how though trial. that we So there been

within we effect at populations. mechanism, the patient empirically, data the population. beneficial to that think this seems have optimistic that's something preclinically we a but across work on peripheral other that mechanistically both to kappa have fact has can that We're that So based we I look it and all patient generated

Annabel Samimy

Great. Perfect. Thank you.

Derek Chalmers

Thanks, Annabel.

Operator

from Thank is you. Arlinda And from next Canaccord. question [Operator Lee our Instructions]

now is open. line Your

Arlinda Lee

my filed remind how will curious are And requirements more you the of Hi Thanks. have some could then guys. or for that clarity on Thanks priority what pain, by taking patients to now? you the about need exposure Can for I'm you many filing? you right statistics will duration high file? talked You also And and extension? mentioned us question. some you And what you've a getting the for that on time? the then guys I'm have is on open-label provide wondering regulatory postoperative additional how – time you

Derek Chalmers

the on last for question. question so – thanks the Yes,

on we've On required the effort last terms the regulatory our there as we that's we've is really a some one, And fund position on have path, there pretty think to The exposures. priority come pruritus here we're in in relation the our I for so main effort help safety focusing clarity you done to and with where clarity said, PONV to some work the as and in far to package, get effort. consistently, labeling PONV endpoints partner is know, then appropriate any much that of in an side. stronger be we'd and look of for

for designed question, are in we've the the for application. that's first guidelines And Injection how relation KORSUVA on to exposures programs. that's our and program that X,XXX So strategy ICH the

to the possible levels XXXX, get ongoing to that making fastest in that So the those exposure extensions have trials as mentioned NDA. get those on I to both path the you sure call study XX-week so extension we add are exposure know with safety looking Phase and up and we we've exposures started been can IIIs beyond to

we program explore As normal our we whole with exposures. first a our counting path, we safety with on pivotal with certainly you is U.S.-based such is guidelines, breakthrough can FDA. to exposures the is compound ICH the designated possibility FDA. a not KALM-X file know, with but which explore But will we've X,XXX that have once accommodate it’s that something less We're a we'll data designed is there compound certainly something

Arlinda Lee

Thanks. great. Okay,

Derek Chalmers

Thanks.

Operator

Thank you.

Carr is Needham. from question Alan from next Our

now is line open. Your

Alan Carr

thanks for taking Hi, questions. the

NDA, Just feasible to non-clinical year KALM-X? after it one. of on you to and follow-up stand? completing KALM-X work those the file comment MAA needed last where And items with for by on both also NDA, do Thanks. Is the this are the then for end all can you

Derek Chalmers

need non-clinical work complete, basically preclinical the everything finished. All Non-clinical the sense, take one last senses is right, almost we were me Alan, let in first.

safety file as And as looking so studies of course quickly completion what to two our both is then our afterwards. complete point and and we're working out, can studies on of then on those of now extension as we're and you – KALM-X KALM-X we pivotal

a we later to guide more advanced more little we on we our if and able like is we This this our little to KALM-X know later this can fairly, a be we from and So KALM-X will something readouts study. year. have safety this year, with where guide accurately XX-week you are we've once

Alan Carr

Is How the end of that a that work? with else? FDA meeting Phase of after formal it something sort first What would would III your Phase or be – that III?

Derek Chalmers

Yes.

breakthrough request a So we frequently. meetings fairly can first thing with designation

later another with FDA. pre-NDA So the we little we'll use meeting and meeting reserve interact for a probably to our standard

Alan Carr

then any how of in Korea they're progressing terms collaborations updates Okay. your of And one, last with – on in or any in Japan development?

Derek Chalmers

is the outcomes sub-license, data. the certainly see relation we with The they're both commercialized we'll in Chong CKD and in in know in as advanced has patients global those Kissei to or Dang you and III. progressing. to are of hemodialysis Korean us areas Both well Phase Pharma Maruishi working Kun participation program report that and when

Alan Carr

Great. Thanks for taking the questions.

Derek Chalmers

Thanks, Alan.

Operator

Thank you.

Esther Janney. from from Our Hong next question is

open. is line now Your

Esther Hong

Hi. questions. taking my Thanks for

agreement patients, over on have your owner KORSUVA would that partnership you've the a so clinics? owners had the the look? Vifor one first the with IV a in allow commercially my to that, largest they we also discussions dialysis how the the Fresenius hemodialysis And U.S. so you the Fresenius, specific other would of of Could largest of they in Vifor one got would imagine So partnerships you DaVita, to Fresenius DaVita. then with be significant in partner is center U.S., certain with regions? Thanks. KORSUVA in in Would be clinics? IV it beyond majority to How rollout terms

Derek Chalmers

rights deal Japan point, Vifor the on South have Esther. so we territories the Thanks, some really – have in Yes. with and obviously European not in so we region, Fresenius the is last have in Asia Korea. the To agreement ex-U.S., focused license Pacific they

population XX% Fresenius clinics, patient co-promotion Within that's the in the we U.S., in have agreement about a specifically U.S. and the of

are do so. vast preview Cara’s So market within free to guess majority, I the and will solely that we so solely population are in and and XX% remain do to we planning

any to arrangement, So the other no agreements set any up. that's We So and dialysis of was relation us providers your and set co-promotion Fresenius and What the U.S. other type and the license with with how interact difference we question of can up these can in in providers. Fresenius? way restricts dialysis

Esther Hong

that DaVita is Do discussions or you with an option? expect to have

Derek Chalmers

we as our do plans. advanced We commercial

some dialysis only – be to. providers will the DaVita, talking of We be other independent but not will major

Esther Hong

great. you. Thank Okay,

Derek Chalmers

Thanks, Esther.

Operator

closing the over for to no back Thank you. I questions. Chalmers to remarks. showing At this time, Derek further would call I'm turn like

Derek Chalmers

and Great, the thank our who to the team call. you. all in And like our participating programs, trials. I'd to supporting participate our for and thank and you their today's Cara various of investigators, to for study importantly, continued commitment work continue most everybody in clinical thank patients hard

So to thank very and everybody we soon. Thank you much. you updating very look forward very, you

Operator

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

day. disconnect. great now Have a may You

Cara Therapeutics (CARA) 12 Mar 192018 Q4 Earnings call transcript