CBAY - Earnings call transcript Q2 2018 | Cymabay Therapeutics Inc

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Operator

Good day, ladies and gentlemen and welcome to the CymaBay's Second Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the Company's request. It is also being webcast live on the Investors Section of the CymaBay website at www.cymabay.com.

to call like to would I turn over the Mr. Now, at Vice President Menold, CymaBay. of Dan Finance Mr. Menold, please proceed.

Dan Menold

second results Thank Earlier a our today, operator, we XXXX you, and issued press good release business update. and afternoon, everyone. quarter financial announcing

website that tab. our the Investors You can on under access release

programs Joining me an Scientific Chief clinical Sujal up before position Officer. will provide today call on milestones Shah, Dr. our Officer, and McWherter, Executive on Q&A. Dr. review Chief Boudes, Chuck the update we financial call Pol the Medical are upcoming Chief and Officer and They open for

Before to the under clinical forward-looking statements made Q&A Litigation statements Private I XXXX. events future we including to plans during are Securities relating prospects, begin, including expected CymaBay's would remind everyone the Reform plans defined session call, as Act performance, like this of conference business that or

no subject the consent to turn expressly would any a Reports results prohibited with CymaBay the well this from time, risk actual to is reasonable set and factors forecasts based materially the I the Participants anticipated of outcomes filed recording rebroadcast CymaBay's for the could as statements new and and that to statements Although or believes factors. impact the press due except events information, Company This as those assumes are call by forth result are forward-looking risks expectations reflected of release, forward-looking from assumptions, those statements. actual Annual differ the such At materially to today's in differ and obligation as call upon to Company and set is in of forth to over the results in The CymaBay. factors forward-looking could without any future update or of Sujal. to required as otherwise are statements the whether written Quarterly directed many law. like in cause supplement a SEC cautionary uncertainties that or property

Sujal Shah

call Thank focus that near-term to keep the the catalyst of everyone opening clinical including of brief and good de-risking first, the we in remarks driver questions. before to I'll quarter second today. upcoming you, on we things and significant review take us progress we made and my all I'll on key activities a remain Dan, afternoon, recent you joining were or growth Primary Cholangitis in of central PBC. three of further Biliary with seladelpar

study dialog or study of regulatory of advancement informing initiation finally X seladelpar and diversification a Second, Phase Phase in design IIb of the with pivotal patients NonAlcoholic PBC development with SteatoHepatitis our NASH.

First, last April. that treatment these current X in anti-inflammatory establish used We and safety in be Congress provide over highlighted and Paris that and doses activities as presentation our for in Phase second results exhibit patients from favorable tolerability quarter of data the a International Liver XX with the hosted in XXXX EASL late PBC first by II a the our from ongoing believe with advantage PBC. recap breaking could study line Phase at of call. potential would seladelpar seladelpar in XX-week were anti-cholestatic

Investor achievement significant at in study, the period orphan of over into a we completed short over our time Day patients such and enter with As disease we announced enrolment Analyst a PBC. as in relatively XXX June, an

of year from of fourth ongoing one XX patients an in the In results of treatment. long-term extension seladelpar remain that completing expanded all very a are the from we XX plan on of to treatment encouraged II treatment study, this including elected Phase set first to those We patient completing quarter, weeks provide study.

provide of We it a the planned to X in of measured. benefit important primary conclusion continues believe the the Phase information study regulatory submissions an timepoint endpoint will seladelpar is make As contribution to represents at a X duration and as reminder, Phase is about risk which the treatment regulatory development. key this key weeks study XX at

in The and US in to study of interactions second for Europe, planned a finalize PBC. area focus design X our in agencies with centered Phase on was the of QX our seladelpar regulatory

will the line second currently PBC. would profile target Ocaliva treatment that better improved support of We treatment PBC a a the in label for only demonstrating than and efficacy approved second tolerability line

therapies engagement for have we We FDA the need for of pleased the PBC. EMA's level reflects that patients been and with with believe improved

milligrams and a limit or upper placebo-controlled the AP XXX to two During approximately times patients or be least a randomized Ocaliva, we proceed X.XX double-blind an level Day, with receive of rate study below highlighted in with our be either our placebo plans of will study AP X Investor which a one normal numerical either Analyst in responder changes XX% Phase normal potential months the to will X in to pivotal met with rating NRS. dose same the designed have pruritus six at primary that pivotal and endpoint. primary XX XX The XX for patients those milligrams normalization of used increase and regiments of dose after responder will yet secondary achieving be patient Key milligrams endpoint measured total to the seladelpar as not from rate or the the reduction endpoint scale of bilirubin baseline at specifically a is the phosphatase alkaline weeks. a by

are the remain actively on this We global start of on initiation year. track second this half in working study and to activities

NASH. patients in we to with is enroll ranging biopsy liver intended in initiated made XXX approximately patients at concept placebo-controlled PBC, the Phase investigational to of double-blind US This NASH a in a May proving we've addition that Finally, study is study of dose Xb proof we in centers. that randomized with progress announced study seladelpar

XX%. from to XX, NAS primary NASH XX-milligram versus a XX are above NASH equal from fat X. patients outcome or non-cirrhotic fraction Among efficacy activity placebo. taken to fat NASH taken samples score Seladelpar once of the at and of method change be The as and doses evaluation resonance fat secondary fibrosis the and weeks MRI-PDFF. measures will to will stage content and biopsy We accessed the liver at magnetic imaging or A histological as fibrosis in be proton and efficacy evaluated enrolling liver with XX content or comparing of baseline superior at by X equal liver liver improvement or a by density X XX baseline measured is using the daily weeks.

treatment MRI-PDFF include fibrosis. inflammation markers as XX XX assessments and and weeks of as non-invasive reflects planned Additional latest well innovative liver of the at use the imagine that measurements and bio-chemical

Dr. investigator for world-renowned Research. coordinating this expect. Medical closely are Harrison, collaborating and a Stephen study Clinical We with of NASH Director Pinnacle The

timelines the is we Although future. and study near be by encouraged the very far it additional are in for expect still to provide early, very thus our to guidance on able experience

of X and As NASH. we other both continue NASH. for strong development PBC end well, of includes half Xb At NASH which in the in in study continue operating the of as and operational to Phase progress sheet key we as million PBC seladelpar we funding study our in in investment progressing and PBC objective this current second balance support second equivalents well had enter With additional a year, the our programs Phase evaluate our and XXXX, plan areas pivotal pipeline. short-term are of and cash believe in $XXX to our quarter, with we pleased the and extremely cash, into

these additional of and seladelpar been to would questions. areas pipeline for to-date the look establish programs other unmet seeking focused Operator? ongoing and activities rationale. medical formalized. as with more opportunities us in are planned Our development identify various Thank scientific again evaluating understanding indication. need The to joining having you today. have future We thought potential of clinical We take in on effort leaders forward and for be and happy the discussion your an about now to for

Operator

of Our ahead. Thank from question you. Instructions] Rahimi [Operator Capital Please ROTH comes go first Partners. Yasmeen

Yasmeen Rahimi

Hi progress. and maybe the some versus Question versus Phase trial X is goes to the XX? Pol. continued same measure open upcoming months to Phase provide Can X, elaborate insight label also pruritus the of did measured X what Phase why you us decide team. And is different? how on in on your what is pruritusin you six on Congrats

Pol Boudes

Hi, thanks for the question.

we X the study is the extension visual the we have evaluation have instruments are we analog and compared half the are the we beginning PH the using score. to the study. The as alterable having of the first evaluation So, same that difference classical scales now not the from much of

bit that little do on are goes that X you that which a Now a to going to one to and much VAS is the and ten are correlated going an we a to to the which use scale The process. VAS scale for with different have is electronic is the you we're we're from level pick numerical from with Phase study, XXX VAS. going where something basically use very

the of XX. And think the was months Phase program. six last your versus So question of in that's X the difference terms - with part I

do want measure But XX. to We month you for also the analysis, to are fibrosis. months analysis six at the are going primary if going is be to going the we data

Sujal Shah

well and And literature, NRS extremely you the correlated are if over Yasmeen, I published VAS XX%. can also the look that into add

frequency done of that's rating it's numerical both of the So, of for ourselves in a of work verbal XXX the Phase to of a and all XX a of PRO zero study. measure X is bit make from between system zero around scale to the methodology certainly patients in to that We've listening the visual difference a scale around incorporated the the design terms and fair feedback assessment.

Yasmeen Rahimi

you, Thank Sujal.

Analyst advanced thinking trials like around us bit defining how exact you population color mentioned patient and I Can with follow-up, regards maybe some you little give during a another study Day may timeline of on your that? the with are patient PBC one look color As would that on ask the you size disease. to about

Sujal Shah

guidance a this for us be at give around would the think I how Yes, study to designed. stage specific bit it's premature

more what from for clinical talked key study. specifically and this proper in trials our in with thus experiences think truly in severe studied patient purpose is is The more intent the the for different here the importance approach there exposure, very that from an and both from that population X Phase recognizing is have different really, an about is been in population we And a dosing population well. population and clinical severe an Ocaliva far that is predecessors a in this I and broader understanding taking much understanding of PBC Phase our understanding there benefit our very population. in really is regimen this X importance difference in safety recognizing perspective there

seladelpar. to perspective us order truly in necessary a population the from the advanced the overall in label very do high-level for to to careful idea is information and something So, give measured the inform

studying we in agency the this population with as discussions and those discussions to detail give remain look some So, further ongoing will progress.

Yasmeen Rahimi

team. you, Thank

Sujal Shah

Yasmeen. Thanks

Operator

Our Please next question comes from Jaffray. Tyler go ahead. Van Piper of Buren

Tyler Van Buren

Good afternoon. Thanks for questions. taking the

results So, XX we're of weeks. clearly XX in AP and positive in seen reduction

give us are So, translate may could that data your Phase updated to and you hoping respect success? rate ultimate the thoughts you it just with to X see responder what and study XX on how to and week

Sujal Shah

group start XX in. around I'll can alkaline the Without least weeks in Even baseline maybe very we AP study. dataset. through you we responder or dose decreases approximately EASL seladelpar had the you don't whether in the be effect you liter where a between XX question of We're as the weeks perhaps if through in potential for range encouraged think the we and can't as at seeing compared in head that jump rate AP at see X But the team far at of Ocaliva in and higher the XX and has Sure, at the about have that improved per XX% just milligram greater phosphatase least there anti-cholestatic than were Phase at milligrams appears week the a to XXX head from and are dataset the look saw rest thus timepoint the reductions units to and with transaminase presented of which by efficacy we X to enrolled XX% XX been seladelpar baseline we fundamentally is patients it progressing, what X demonstrating where coming data. mentioned XX%. XX%

you able continues There AP weeks. want through see So, level and a typically the What we be anti-inflammatory what response reduction of encouraged AP continue sustained expectations and that activity that as XX and vast the have should that we to we of XX weeks isn't to overall the seladelpar also for AP to support between XX to and of is we increases be seen important and able continues patient I typically we observe what the continues as decline, actually to same in the XX. want us of XX the of by that necessary very XX% as seen that XX XX, What response experiencing setting see It be as see be is and setting sustained weeks. weeks. between is have XX more in in mention With response of see to to we through to many normalization that is of patients data XX% sustained. level course from saw profile to safety well. every the level to

key another observation the So, XX-week in will that data. be

Tyler Van Buren

in the program. some in do differentiated and X by seen four enrolling on reduction liver of what enrolling finally the severe I side to some Yes, with opposed the think patients? you seladelpar just compounds more stage clinically in mild So you fibrosis three obviously levels thoughts relevant? what your of programs to Phase question. as curious of think Why with other is is do through mechanism one fat are I NASH there. which of we've then to the get with MRI, might be more stage the terms guess general guess, And patients more and three that one respect

Chuck McWherter

my I'll well. is and respond want as This that on add to Pol to Okay. may McWherter Chuck to try to comments

hepatic First of fat expect. to reasonable the level of all, reduction what

could se has leaders interesting It's It's potential and Madrigal because or in the fatty XX% you NGM-XXX thoughts reduce. XX%, perpetuate instigate leading and want to this our then now in around more XX% of that view inflammation right not fat. even been than hepatic levels by somewhat of reduction that's both hear champion the rated necessarily that a the It's seladelpar we in more acid what fibrosis. still coming think think field. them and inflammation I other that to I less per offer. fat be may to But lower to echoed fat and lipotoxic have

its be by stands to as seladelpar PPARd peripheral in via is peripheral its out particular to about as period as On [indiscernible] ability we source track cells a shuttling phases where as which on it NASH tissue to and during oxidation therapy the in effect. fat max saw is liver a fibrosis well tracking effects XX%. in So, in fatty reducing well foundational in cooper well due in believe both acid as reduction direct anti-inflammatory we of in fibrosis as

think XX-week at result in day, primary which fat. the out But to the read the So, kind stack end we the find was importantly fat I have results, we'll a seladelpar hepatic a really that of study population up we'll recap, to and I we're measurement. our this in will to of interim - think first hepatic where histology just biopsy link help out in base

in practicality. In population we that FX to true it's enroll for the terms FX of

but on widen bit, a sponsors NASH. well FX study well. going our that do FX those expect lens the and over we and patients of as FX think Typically, I You FX are to half this and the in that non-cirrhotic for we have focus little

in on we pathology, advanced our to on anti-inflammatory don't get know is So, the metabolic more we Pol would study cage And on I into you day effects features I that want where that good fat and on of well. comment? a would we expect and results translate think see as will anyway. end the in pace a the at to able NASH focus this the fibrosis be read

Tyler Van Buren

that if and specifically lifo-toxic measure see to able clinical there mentioned with any be you is that fat correlation outcomes? you improved Will

Chuck McWherter

just can terrific as benign able in Yes, Not in We that and saw extensive palmitate do would hepatic which fatty mono-infatuated do well sample to in chain we been actually pretty is glycerol be fat strong we various hepatology which of as well. fatty that lines if acids triglyceride, could of acids you panel saturated well and communications published in we We've as reductions. but it. liver. total did where arguably as mice a lipidomic actually

we we reason the modulating pathway strong would So, have we answer livers. short the same a we that upon But to think expect have will the suspect in human I fundamental are is that based no. that effect

Pol Boudes

And Tyler the or of one the lot of PPAR a of potent Chuck talked about we which and components metabolic a delta mechanism the the question differentiation you agonist asked seladelpar some encouraged around by. as are selective

the that in agents in to is also Another today but the studied not differentiator relative of peripheral effect liver, has some seladelpar only being tissue.

about you [indiscernible] and effectively and Madrigal muscle. from that d of which agonist seladelpar elafibranor periphery mixed the directed receptor liver also if PPAR beta particular action seladelpar hormone the ends as the is think post in So, expressed more the comes liver in XX% and in of the up has fats direct, liver thyroid or in a/d, the PPAR

understanding as very and enthusiastic do course. one without feature in the that know acid robust Chuck LBL XX known really it's these we're has synthesis inhibition only as from of that inhibiting of our that and increases on impact about have on seladelpar key fatty around not that differentiation that FTS outlined, we acid we the bile effects FXR the acid is impacts PBC fact the of bile promoting of this oxidation has better experience the effects and mechanism So, of the well synthesis a

exploring excited some lift that delta really we're study. we the in space key around So, there to the are differentiation that elements here of

Tyler Van Buren

so much. you Thank

Pol Boudes

you. Thank

Operator

Thank you.

ahead. go H.C. Arce question next Our Please comes Ed from of Wainwright.

Unidentified Analyst

Matt is for on this afternoon Good Hi. Ed.

This September of a XQ PBC trial set for being Given event? for the more the a XXXX. currently likely timing seladelpar

Sujal Shah

would get towards initiation. we with be is as you update study which activities to you to have this all what internally on over that global With a all closer tell we be going the to bit initiated. geared little here I can excited of XXX precision getting centers been that of a

well the as an update internally make the and continues give So, move to progress commences. we'll here sure and very study

Unidentified Analyst

Great. Xb is given so study How clinical tracking Thanks. far current competition? especially the the And POC rate the in Phase enrolment for then or recently all initiated NASH.

Sujal Shah

first any do enrolling design Harrison, study NGM that outlined similar enrolment as early look off days Stephen principal the investigator really make Madrigal. XX-month with we're size don't the continuing comments to been seasoned in We've NASH, at to Things experience us really about has our that similar we're for helped We the But study he's typically on very between study is and principal at in timeline to worked in study. enrolment. our as us elevate of It's this enrolment benchmarking that in that timelines that The and attention specific an very to are studies. conducting Madrigal what conducted well this patients. for investigator XX having today. we centers given are progress both has

at center. couldn't be of pleased level the from more we So, engagement

that is selected Phase my have at program. the top think really as from of correct, study Every Xb well. this the You space. involved, our our emphasis the in at But every for perspective through the study enrolling list competitive involved center other are this seladelpar for patients the move absolutely as very I study a we is course centers studies been on of

be of we're provide months very course feel more precision in that we So, able and more around to timeline. come to no and encouraged the

Unidentified Analyst

Appreciate again on congrats progress. it and the

Sujal Shah

you, Matt. Thank

Operator

comes question next Please Our Olson go ahead. Jay Oppenheimer. of from

Jay Olson

the study endpoint you as was sufficient for for was efficacy both the if I Thanks pruritus significant and show on PBC improvement I and Hi placebo. And power which product tolerability. profile a my about differentiated guys. have in a curious to seladelpar wondering you versus target if secondary described taking being questions.

Pol Boudes

Hi Jay, it Pol.

think of answer in confident program powered simple trial is X appropriately on on outcome. yes. I the the with for think our experience are the is previous we Phase we right the that the trial are seeing and Based I size based what the

Jay Olson

to data Phase biopsy you Then similar were PBC for a long-term be was I Okay. a there was some PBC that. if in long-term fibrosis. for study. you patient Thank in wondering going or X biopsy extension collecting And showing for then you Ocaliva data reduction patient to perhaps

Chuck McWherter

Yes, very I think Ocaliva the represented data interesting. was that

the So, we going to kind introduce of are to same try things.

PBC is the you you away practice place practice the are a As medical But good think doing And depending patient. know is the I going valuable in idea. working. from very also biopsy on it's

much said, to as three have we're take So, the And possible. going because this to of years expansion study going also get after it's as top but phase partly to be sample the you try to as of treatment. you

Jay Olson

Thanks Great. Okay. for question. the taking

Sujal Shah

Jay. you, Thank

Operator

pause are line of more question time, Raymond And to closing would comes James. floor one at Steven your we ahead. back I turn Please time questions next over from go no like Our Seedhouse time. this will Steve open. further at for to is this momentarily. just There comments. the Shah Sujal

Sujal Shah

Thank you.

today study As our through in on concept we the enroll, X that know of to Phase Phase study second focus study in our proof this look pivotal of all rest year as and execution half year the NASH. and PBC Xb efficient you in of our the initiate the remains of

growth providing have by ideas our for begin and updates and in we a and dedication these be hard the the in addition, being more the look involved for here not you put exploring to future future as in call. position put again on company to forth opportunities program. worked mature. the by very pleased to Thank effort forward I patients ourselves In at in today's everyone could next investigators

Operator

teleconference. This concludes today's

Thank You may your you this time. at disconnect for participation. your line

Cymabay Therapeutics (CBAY) 9 Aug 182018 Q2 Earnings call transcript