CBAY - Earnings call transcript Q1 2019 | Cymabay Therapeutics Inc

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Operator

Good day, ladies and gentlemen. Welcome to CymaBay’s First Quarter 2019 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. webcast at the www.cymabay.com. being the section also website CymaBay is live Investors on at It

President CymaBay. Now, call host, Vice over would to Finance I like your Mr. to Dan may Menold, you Mr. turn the of begin. at Menold,

Dan Menold

and XXXX operator, I everyone. business financial to results afternoon a issued announcing hope release the and press good we had our chance you, Thank you’ve review first quarter update.

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

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

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

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

Sujal Shah

and us for joining everyone, afternoon thank today. Good you

upon plan first We continued medical beyond. as XXXX in few of year and accomplishments of build inflammatory well to with unmet The the for our liver we of rest months recent progress have to seladelpar this the advance diseases the in needs. positions on multiple high our deliver us development

accelerated and most PBC. We in continue ENHANCE, complete to an pace, study registration year at our important one objectives Phase of is generate to our seladelpar this important for results clinical in global X enrollment

have announce the seladelpar top-line plan. designation end our quarter. study the And early treatment of second before with of were of in Xb to biopsy well completion NASH, Also we of therapy original PBC. breakthrough we of February, expect of for in for of gratified the enrollment are study We granted Liver at regularly clinical FDA we PBC the to open towards month. results this ongoing that also been our driving in label which Congress of half including updated just year, we reporting delighted has medical were announce major X International meetings, second EASL’s the In February, completion Phase patients to seladelpar confirmed Phase our announce at last now ahead stage to for date

X and of inflammation in evaluating in placebo least have UDCA. equity in inadequate an or limit primary AP, less and characterized of are ENHANCE, X.XX patients as liver portion registration $XXX extrahepatic ranging ursodeoxycholic Phase XX-weeks there seladelpar Finally, a with in seladelpar study. PBC, times the intrahepatic the raising bilirubin. enroll proceeds, offering, year-end disease and us through global level in Phase in PSC, first-line a with early no from by is announce top who XXXX. to we of put treatment a which the of data an baseline the of normal evaluating XXXX. upper or placebo-controlled Primary milligrams responders by total fund decrease in after line patients normal endpoint patients in level chronic Beginning had mentioned, XX% would million versus which ducts, with study, a rate net and safety to of AP, an position seladelpar acid, X continue approximately XX-week is and to milligrams year-end X is proof-of-concept period phosphatase currently XXXX efficacy follow-on orphan This XX-week achieving bile PBC, on remain Cholangitis, XX This Sclerosing therapy. patients completed in at cholestatic March, response of or double-blind in enrollment have we with treatment randomized which our or intolerant We The dose completing for study alkaline than a responder are a focused approved by fibrosis the I will and

primary Phase of seladelpar a ENHANCE is study. substantially second interim better by the confirm ongoing study, the in an the study as supporting and data X XX% XX ENHANCE of XX-week an seladelpar resulted XX-weeks markets. endpoint obtain order line milligrams reaching believe has Phase analysis in and profile efficacy treatment approval objective Europe, improved over composite in rate, to with the for to treatment Phase patients In X response de-risked on in to in competitive X, ongoing which is patients of regulatory tolerability the PBC. responder We potential seladelpar’s in the provide other in X Phase Our far been that the the observed U.S., thus ongoing

seladelpar decreases PBC. through and action XX-weeks reflected anti-inflammatory baseline, only at markers important X to also produced seladelpar been Importantly, is in found the sustained regulatory transaminases, from levels seladelpar not has of by in an XX address the authorities. PBC treatment. greater recognized the than effect an also XX% been of have also milligram that which of supporting was aspect Thus in composite endpoint, importance has cholestatic potential but transaminase lowering on The

to that presentations number data FDA the minus granted the unable AP this at treatment quarter, in European the Seladelpar, believe significantly patients clinical minus anti-inflammatory respectively. Agency. PBC. designations decrease by to in April. Dallas an in of absorbed an this alternative at a comparable associate analysis the patient prime was for We corresponding from Marlyn as Dr. of in the Treatment milligram improved oral for in Medical study. cohort that a the the combination Southwestern X decreases be interim International Liver data for Medicines seladelpar professor in patients non-cirrhotic Vienna, a the adult early-stage milligram, Texas to mean PBC significance UDCA. with activity with XX% that the tolerate reflect of were of with of in an these XX of in results both UDCA, study. and and also adults seladelpar a the cohort in Phase treatment group and potential and PBC cirrhotic seladelpar group at monotherapy with During relative In featured was for designations University delivered inadequate XX-weeks, Mayo, in compensated XXXX, or XX in the therapy the with patients Congress seladelpar received our the in presentation response with first UDCA to breakthrough ALT to from In seladelpar XX% five also demonstrated Center designation

decompensation safety seladelpar event. and no with demonstrate a transaminase favorable continues no signal Importantly, to liver safety profile

associated not was treatment with or in seladelpar addition, hepatotoxicity these patients. In drug-induced pruritis

the a study Phase the with The NASH, also in XXX disease in at NASH ALT fat as hepatocellular with MRI-PDFF. primary seladelpar injury assessed we using with enrollment biopsy magnetic placebo-controlled NASH quarter treatment measured study planned treatment to cholesterol schedule. proton duration that placebo endpoint imaging change of density on to Turning be as XX-weeks. fat of early seladelpar will be well important and announced and in weeks resonance double-blind from February patients as confirmed treatment of XX-weeks. This into method on was approximately Xb ahead triglycerides randomized activity completed and content is by or marker milligrams, indicators fraction that of stress or patients Effective XX, XX the in of LDL XX, arms seladelpar or of one enrolled inflammation will hepatic of baseline XX for

using Thereafter, NASH fibrosis the CRN to NASH blinded pathologists will biopsy a by to continue study treatment culminate week-XX and scoring. in examine improvement expert blinded determined as with histological and

XX.X%, the liter respectively, a FX were in NASH, diabetic used of FX average this is per biopsy evaluation will X to Also NAFLD XX% comparable criteria. with of to Score the study. patients of About XX were Activity an and patients levels characteristics and mean find AST ALT significant those features in this recent stratified or X.X content half fibrosis. liver of randomization limit units and permit endpoints liver fat the study of revealed including assess non-cirrhotic histologic and They upper enrolled Importantly, on XX stage Phase patients was of advanced mean of the normal. above which us

evaluate an the represents which in in we cell this NASH to disease setting. this together, believe activity one ideal of Taken population seladelpar

including for Phase that optimized we doses. development, of believe on Importantly, population selection decisions X be to making

baseline study expect of measurement liver at end second several hepatic quarter this resonance elastography have We inflammation at mid stiffness the and built top-line and primary and to expect XX, results additional and would time It’s the of the for that multi-scan report points. additional assess including to highlighting further pathology the to worth into endpoint year liver in liver week results XX sometime many XXXX. on fat magnetic of MRI-PDFF XX assessments by weeks at

multiple imaging the action. mechanism assessments serum are by fibrosis, evaluating seladelpar’s addition, of In and biomarkers supplemented inflammation

we able goal is activity this would that development significantly enable the be NASH informed to If to of de-risk well regarding profile development study NASH. indication. this decision to this Our in fully a believe seladelpar in in successful with seladelpar’s its

financing PSC. of developing disease. Patients which clinical a to intrahepatic degeneration can disease obstructions are is characterized also ducts. of It and development ducts of chronic at bile liver from into with As mentioned cholestatic inflammation end an consequent will progressive bile extrahepatic expand of risk stage to PSC a progressive indication, is cholangiocarcinoma. earlier, a high March liver lead of seladelpar of chronic and use fibrosis be proceeds in the important our new by

inflammatory in XX,XXX the disease unique the it effective set significant bowel a an U.S., treatment diseases is liver accompanied biliary has large tract. to its obstruction Although comorbidity the inflammatory with transplant. being of his characteristics of approximately affecting by degree only related PSC including patients like the is indication PBC orphan own PSC of challenges currently an cholestatic and

study proof-of-concept We seladelpar plans to of ranging FDA our a have had regarding with X positive discussions Phase with the for patients conduct dose PSC.

are study of study We finalizing intent the with details initiate design the XXXX. of second half to currently the the in

finalized. as We further the near are will provide future our details in plans

marketable Turning were plan operating is into current our cash our securities projections, $XXX cash, million expected the on to briefly financials, XX. equivalents fund Based to at current and existing cash XXXX. March our approximately

detailed with the now SEC a release the For press March for XX, the refer our Operator? the ending open our overview I and today. operating to I’d period questions. to month filed three of to to like you call results will XX-Q

Operator

time, question Capital be your Yasmeen with comes Thank with session. first question-and-answer proceed we’ll this Instructions] conducting Roth Please Rahimi you. At a Our question. [Operator Partners. from

Yasmeen Rahimi

progress. on is Hi, continued And question for the the Sujal. you, congrats

with bit little study physicians So current maybe a to you us color who data speaking expectations. are regards the as NASH involved can in you’re in give

investors I guess, the to excited ALT well data are MRI-PDFF AST. and So most as see really as

to And a is physician, of proof-of-concept matters what So to about most reduction what one look then have it ALT/AST, care I when more fat they study MRI-PDFF and improvement? NASH, measured more it what is linked at when by them in is question. speak you do follow-up the they or histological

Sujal Shah

Sure. for Thank you question, the Yasmeen.

just histological as study know really that this biopsy think course, important in to you fact out XX. space an this have paired sure well is evaluate the we’ll improvement is I a this of point at in have Phase I imaging. a And criteria week first bile seladelpar that it’s make opportunity study, the assets And as to to evaluate on X wet markers as and well has at at XX setting noninvasive on set inflammation weeks. of well effects rich also on both beyond of to looking in biomarkers compounds even the acids, markers fibrosis NASH. which of of as study as opportunity The

a is very indicators the weeks, really it with of not respect beyond. study, rich So activity disease but even at early just XX to

the at on XX weeks, pointed importantly, parameters. to of at effects top in opportunity Now importantly liver an as on out as we’ll fat effects at transaminases and you’ve have well line seladelpar as look lipid particular in changes

of just these a me few Pol I’ll ask chime dissect Chuck let to as So and well. in and

had gather we’ve really the field. thought opportunity of wide to First a NASH of in leaders all, an input from range

fact, fact, conducted a those of highly we and Advisory NASH, discussed. believe one In targets was pleiotropic selective Panel really one in had the believe in of that had entire NASH been field this And we given where PPAR-delta most EASL as in today. potentially seladelpar exciting agonist, a setting topics Board being meeting has in of that potent studied the NASH the effects

lipotoxic-driven fatty with XX course just at in one and fat observe particular consequences in think see may seladelpar, PPAR-delta the We liver here And that that acid respect weeks. is in across see and changes parameters a expect with Liver important read We of what early It that XX tissue. insulin improvements component comes at in effect including time hepatic differentiator has be element the will the an each inflammation this resistance metabolic know to seladelpar to these of of fat in not we fibrosis. drives we on but of important week point. this is peripheral oxidation, fact key NASH.

PPAR-delta know bile synthesis. that inhibits also We acid

nature in are at of reduction also So in includes look when and acid which of proinflammatory. hepatoprotective lipotoxic seladelpar, fatty oxidation bile acid, delta agonist the in in cholesterol, not you reductions reductions only lipids, free a it motion

benefit PPAR-delta in a that would reductions given decreases where expression meaningful in seladelpar effects seen of NASH, in in can And in triglycerides. potentially but inflammation, other only these markers. cholesterol, of potential you of have to transaminases. many also I’ll in in not LDL versus you inflammation the as that of a we’ve what we out PBC, of transaminase, in also reductions with by be Kupffer seen of as variety patients different patients as point PBC very fact fat, well although know, a expect setting the will studied hepatic we’ve So the in be robust have in course, dyslipidemia PBC and on anti-inflammatory obese macrophages effects seen cells of in mixed circulating as some course, way we’ve portal

well well of input both early we spectrum, of from of received leaders hepatic as understanding as both, really our key of highlights the in as the across being own the thought fact as changes transaminases So really seladelpar, setting indicators as in fat activity in NASH.

parameters literature as independently, threshold. specific improvement think these associated published above a histology been I of NASH it’s supported has each with in in

fat be So each parameters, at be really, what transaminase at changes key as as looking approach as an we these as think read might early we of we’ll I liver – two weeks. on well XX biopsy

Yasmeen Rahimi

please Thank go you yes, – ahead.

Chuck McWherter

the lipotoxic a of liver the is Yes, histological really hallmark think our the reduction cell positive that there’s it’s general change liver add, it’s fat drive, reduction. of in injury really that accompanying factors Whereas fat to death just regenerative reduction, reduction I calculation. injury, the really response. of reflection only liver thing and I so fat a view is else ongoing fat would and of lipotoxic the transaminase continue Well, the one both

from of seeing of Rohit in and providing we’ve both reduction histological both and change in the different into liver Loomba, that’s those publication, been a feedback that views reduction by So histological example, the are transaminase two the change. terms for fat

Yasmeen Rahimi

past continued Pol, progress enrollments. And question you. for the congrats Thank quick is on you then, on

secret that PBC. we’re show? of you to what are trial. some physician’s or what tell to for struggling you What from your at it getting the Can view We or dataset impressed. just get trials involved? seladelpar least is sauce sort existing the is the of us competitors with So are that And are so incredibly perception exciting want understand physicians’ in started enrolled

Pol Boudes

Are Pol. it’s PBC? NASH or you Yasmeen, referring to

Yasmeen Rahimi

out because year. study PBC To kind have pointed you Phase X target for of the

Pol Boudes

we Phase Yes. chime for so profile collected it’s and factor, the because have particularly the Chuck investigators the in will the very basically mean, for drug where very I well. and and The far important is in. to I good. is that then would XX-week they’re important mean ask I think safety I I mention us data one Sujal data X works in which

because excited something can drug very patient. to offer they’re they know their So the that well. They works

drug So drug it’s benefit profile very risk also really the that cirrhosis is what have the them, the the Phase in so we’re the is not the it’s I key far, we seeing of controlled people with investigators, cirrhosis. to induced of very have cirrhosis is very X for factor also to positive. regard introduce for is And advantages to profile is no trials what be I there’s we placebo positively. speak will impact to a figure on the drug that drug to interested extremely fact when out the – viewed think add

the So the close we data to the with is going thing to the is other Then investigators. mention key I very have what’s think I are actually factor. really on

So we subjective but side, of develop with very a the that’s close more criteria. relationship

Yasmeen Rahimi

team. Thank you

Pol Boudes

Chuck, want to chime Sujal, in? you

Sujal Shah

No, – I think Chuck. that was ahead, go

Chuck McWherter

to great Well, Phase a Pol really terms coordinators the a ground protocol. site making but what’s prior the study, in relationship little bit team. incredible countries, investigators for There’s mobilized access successful logistics think with that really and that in data large sauce, has experience operations the to than and leveraging lot XXX a and as little has with needed is bit to on of patient expanded understand sure front experience in grew is and the implementing This the the more more five study and XX is I relates then continents. to to Pol upon of very just a a especially it’s out X from which It’s investigators modest. available and the the scratch secret being a said,

give to lot credit Pol and his team we think So I of need a to here.

Yasmeen Rahimi

you Thank much, team. so

Operator

Ellie question. question from with Next with your Cantor Merle Fitzgerald. comes proceed Please

Ellie Merle

the Hey congrats guys, on the all and for question taking thanks progress.

the what this reduction the Just on fat reduction, delta. guess in reduction sort the like sort fat Thanks. obviously peripheral expect PPAR would could of mechanisms biology would mass. you you the see PPAR from to on to the of see on incredible context know delta. you particular, of various expect into the delta. mentioned in But versus expect the I and is PPAR what would see between you of I just fat biology the on in To based what PPAR alpha benefits fat between the the in you differences just an elaborate reduction PPAR on data of on reduction for liver with fat alpha focus

Sujal Shah

I’ll you Ellie in, maybe that question. and in thank Yes, for step

alpha think how the type to only in difference I that, be potency needs think we a key remain the of in is of it. not PPAR that of about made part of it its which it’s selling point the really forefront also the,

question with I literature effects and that addition of settling acid in all, to new by then effect drive in substantial fatty in through NASH. fraction delta. the and first obese scientific our two on PPAR delta our think past supplemented respective That’s macrophages that is subsequently there model. NASH the on success And liver in see mouse has the models hepatocyte. PPAR the least at all, your We super in into of of the of state And that. informed alpha in effect content doc liver results diabetic and second to fibrosis in mouse inflammatory injury PPAR are pretty collagen the we Seladelpar a really patient delta, are of in liver a recruited periphery cells that the for from in know hepatocyte in strong by, secondary in reduction the and specifically that in studying the the fight periphery. rationale with was fibrosis role both But of on

here on, that effects Other point but know important in to differentiated development And from out THR oxidation first of delta in peripheral I understand moves potency on I other activity, in as whether agents currently alpha for would restricted to just the to think acid alpha. if in is effect. that and mechanisms the are fat to betas that effect liver. is NASH fatty of respected as I process as reflect on to I accessing which the for delta the are going people all well muscle after Seladelpar liver. of also potential how are as it’s adipose think I mentioned, previously trying mobilization are lipolytic PPAR through has as also responsible

terms that we may PPAR effect accident. of Seladelpar Here believe that maybe alpha. important not And is this expected differentiating. an an additional in have It’s with

Ellie Merle

mentioned might of one share path then sort study one what And versus what PSC any Got just in initial there? very more are study discussion bit be on if regulatory end the the the it. you of PBC, of That’s thoughts just ongoing. any PSC, can SCM, design helpful. even Thanks. that of would as able the curious curious on so quick little you complicated But sort just clinically points thoughts you viewed a and to is be meaningfulness initial as

Pol Boudes

an had here. I a first. couple it can of Yes. jump I Yes, very is here I think question. maybe to important highlight Ellie, in things

and the with is in setting regulatory in a to of where consortium group be a around PSC thought active agency this of much involved endpoint very We’re leaders called the evaluated forum PSC. sponsors, other dialogue

is of cholestatic so for be to, finalize here we’ll the concept study And in be dose effectively setting. It be disease. to important bit this internally, is a will course, of proof Seladelpar this ranging fluid looking a us this but will what of

and that will the a Seladelpar done of we’ve be setting will process in endpoint impact PBC of measure. assessing the our So key

not the pathology of bile there can well. that addition, in as large and terms even PBC greater recognizing that of bile a but well some additional of implication in the degree ducts, just duct of the inflammation course extrahepatic think small disease fibrosis, as patients differ PSC have with of I are elements from

a at inflammation, look wet well we’ll So of as fibrosis, stiffness. way as that noninvasive, NASH, the we’re in doing similar in liver setting biomarkers of

are these give today is are overall not each drugs for us are for seladelpar no there potential improve approved that guide in setting the elements health think only in where this around that some of really I really the improve can to PSC, cholestate setting. liver

so Phase And think opportunity design to we’ve us to it’s we really a as and the very seladelpar we’ll for of a study Phase impacts understand read X significant Xb. and of many as done give in NASH measures patients with PSC the

Ellie Merle

Thank for it. much very you the color. Got

Sujal Shah

Thank you, Ellie.

Operator

Our SVB Sarraf Please next from Pasha with proceed question comes with Leerink. your question.

Mike Kratky

morning. is for This on taking Thanks Good question. Mike my for Pasha.

first XX-week with the obviously So readout the in upcoming just this NASH side things. data, interim getting of this is

So the interim this which full be X how the are study. you versus placing gate Phase mentioned, readout is study, on really importance you going ultimately internally to XX-week entering as much that to

Sujal Shah

then and question, Yes. ask chuck some to off as it I’ll conclusion I There’s things the as perspective with get some chime start for don’t that cover. well Mike. the Thank I’ll well as you in Paul.

I think highlighted it. really you

setting even FDA Phase have NASH X suggests to really guidance you late recognize EMA and we course, of histology. evaluate development need to that stage, Of proper as guidance really do the an and

evaluate histology. a Phase fat primary on the anchored XX-week design without able while to so And endpoint the question, really reduction read Xb is hepatic is of our on ability to our study be

as anchored selecting clinical seladelpar advanced be really be for the driver we selecting combination, driver. and will on all key strategy development doses the as the really It monotherapy will and be development key to look histology. really that potentially So in even

in perhaps with study think to the on us Phase in and forward preparation I success loading provide front beyond strategy some effects the this a fat think able read what setting the NASH. our to advancing potentially be of and move change XX-week Xb ability hepatic about transaminase to through think for on

which and reductions reasons of process, lipotoxic you a particular instigate demonstrate can with can Chuck antiinflammatory you in already highlighted expectation the like proinflammatory has think, that are transaminase. that and way pathophysiology lipid, really I in So can respect benefit, for of seladelpar many by the fibrotic agent an to the strong if remove if

patients I I’ve think as from these have way the all point think… the early indicators anything out? Chuck, is XX-week. we encourage progress that us you Mike XX-week I can think to time left there further

Chuck McWherter

about but you��ve It’s think well, technical it you. covered a that. Sorry thank questions, I yes,

Mike Kratky

question that. for a very a helpful. lot terms Got certainly That’s or enthusiasm you. lot super into you Thanks just follow-up. about And confidence could quick at you’ve of Obviously, in least a much mentioned why, of generate MRI-PDFF going thresholds in the you based early look currently are is, like? might any terms about on, a be interim little readout. My thinking but might a in reductions, of what it of wind on available terms

Sujal Shah

know seladelpar question mentioned, a bile like is the mentioned, primarily of of that as beta this oxidation acid alpha, pathophysiology synthesis. FXR, fatty because key the drive NASH, particular, even think I has we inhibit know we know and we we component that Chuck THR acid setting much PPAR in that tougher I and PPAR delta pleiotropic like in a as here. That’s we effect,

well the externally. know we we that as in do course, this Of as liver

that Kupffer fact as cells liver and delta macrophages. circulating in as is well the PPAR expressed the think, I

a suggestion supports We’ve a also as we be direct cells totality seladelpar, think stellate think I may with more it’s the seeing acid expressed right for to to as activities all of real NASH. in on all this and seen different that the in at targets that again, you’ve picture transaminases, various delta mouse fact of for this in hypothesis really anti-fibrotic form effect. course a collectively consider us to antiinflammatory benefit around look the agent here important these seen of of direct these bile we other see versus And of given hepatic models effects what success. I fat reduction, is

of you parameters impacts I respect to still or improvements can think and histology. with in successful changes biology these in histology all across have varying see

So open we’ve an got to keep mind.

being I many unique think across, in benefits studied other parameters. of seladelpar different the Again, early of these target. on the given what the targets I impacts see here study of to think a in is given across we this NASH variety may the

Mike Kratky

Appreciate and Excellent. it. very helpful That’s again. thanks

Operator

Our from Raymond your with Seedhouse next proceed with question. question comes Steve James. Please

Steve Seedhouse

afternoon. quick presentations the questions EASL. data you. on good Very Yes. recent A Thank at couple

First one, you seladelpar you the look worked combo liraglutide steps talk quite ASKX It had like some maybe well. data any just preclinical Can and there? with combining mechanisms. next about GLP-X

something study is just would contemplate purchasing you clinical just available GLP-X? So a that commercially running by

Sujal Shah

Yes, Steve. thanks the question for

the treating to bit that that our one forms think give the single I learned will be believe is perspective, there others clinical some it glucose done with strategy on very of to field clinical like development compelling about thinking target been we a to combine a And course, GLP-X believers exciting. regulation Chuck loss. think ask their But that little of And various agent. where I’m seladelpar data I is should seladelpar. may fact course, going the we targets. ardent effects things think for a that’s around support basis inform fairly what data development From an of Chuck’s just you’ve it of for to the of We work our strategy. clinical some in in that the us compelling NASH be beyond us groups nailed think And potentially strategy. as I prominent a known of were overview potential of there really make to potentially combine weight in think I of way on

study. have biopsy we but this just ultimately week not as XX this in data So

Chuck, look I of combination. will I we thinking in ask inputs, this some Phase those monotherapy the out only should see of that to to as data But of would I’m Xb. not of that about course work frame we be that question? key type strategy is you can maybe the but of well positive this also advance, potentially think context

Chuck McWherter

Sure, happy the thank to Steve and for you question.

And we so of on detail a in our for poster can work the see the those of call, the a from presented listening on available format lot it’s website. you you that

emerge anti-inflammatory was precedence of We on was fairly reduced it, work but fibrosis. anti-fibrotic. for a liraglutide when driven we pathology. patients good first the because and impact with the really for agents NAFLD both resolution score set reductions was improved it recapitulated fact a in Not from a NASH seladelpar or liraglutide. began we study as end the really in by anti-fibrotic of they to, alluded there Steve rationale of showed that of metabolic, The effect exploration in to the much the inflammatory, small been we biopsy saw model of with was had This clinically. with study As on both weight was That a was possibly on variety is activity And confirmed where dosed scientific combination conducting good its ballooning. this weeks But both effect in liraglutide including the liver seladelpar fat, agents have are set part we that loss. a and published NASH alone where lean and seladelpar in differed strong effect XX combining where and of want year either selected maintained at that study. an

you have think So, two to additional and agents seladelpar fibrotic side the if another were benefit. in and really one steps here that of will, on reinforce add the in equation, metabolic the I compliment inflammation you

as on with I well well GLP-X I with coming strong going as very long as what’s about have combination it antagonist, doing the Ozempic think through especially rationale forward, been And oral as a with of rest as I acting well. mention one. there’s to is well, think think with semaglutide receptor

But alluded in other make looking agents of completing X of small really just single combination some just this We evaluate were doing to agent at very wrap along confirm in the for we to seen confirming at have the the activity rationale think potential with in what additional work Phase to up to we’ve positioning us seladelpar combination setting it work Steve, as soon preclinically. of that’s I clinical this kind decisions ongoing combination. the to

Steve Seedhouse

Okay. Thank you for that.

XX treatment and for I the the on XX-week with study seladelpar other The survival. point data about where is transplant-free looked me at was, to predicted wanted you ask

as chronic outcome transplant-free looked that survival correct robust like of suggest weeks even about after treatment? you robust of effect does as that just was XX of sort it treatment. dosing maximal get Is needing XX weeks the benefit of if So – predicted treatment the weeks what XX interpretation

Sujal Shah

Paul, color then if some and off start I’ll you maybe add Steve, Yes. could well. as

largely each and score, XX biomarkers at the levels think those driven those is between looking that time the the XX difference of at I and by partially biomarkers observed of GLOBE we point.

I and those think effects, Phos order anti-inflammatory you in bilirubin, in in those dosing chronically. on to the need Alk in fact and end, need chronic to those effects cholestasis with because levels, you sustain ultimately anti-cholestatic still order sustain respect to to largely those

dosing, guide the really remain reductions and just survival. long you of overall impacts the So would there transplant-free in is of levels over looking be analysis bilirubin if term some the levels give on to at what Pol? those then the Alk Phos those that they

Pol Boudes

No.

making term up good chronic long transplantation. PBC chronic out and the think time is study, I to on This a over the so including point, patient the unique is figure very a and dosing you’re pull long Sujal. clinical events very then dosing period a of impact

Steve Seedhouse

last or adjusted Thanks. for Thanks get closer focused XX% was it was like sets MRI-PDFF that. get The a just MRI-PDFF, last highlighting, few expectation. placebo too reasonable and sense to mentioned is in like think XX%. on liking had a call I a you know, clarifying just investors that you a it reduction the because that been NGM, Obviously, maybe you’ve data pleiotropism XX% do particular question, Okay. I the are was on I based on

here? you for will Street So fat The reduction, the liver look confident two you report are look it the at that and assess efficacy to digits beyond

Sujal Shah

association question. the Obviously, parameter the this think has a is that an Yes, disease. progression good with I a it’s of

of course be seladelpar it’s parameter important different internally as the important, not variety folks only externally the the able of thing So us think then to across as course for parameters. I of evaluate, here of of effects well if course the of to

as that’s the reductions of variety results couple betas, other for fat inhibitors, You MRI-PDFF in THR that of targets and we evaluated. being highlighted are a their agents know other a well ACC as of hepatic as well at be

of not Some exists other targets well. for mentioned as yet the data

in XX% with a at terms to correlated agents patients as with relative fat And seeing there you weeks reduction reduction, to are we think at a see with would really overall around positivity a continue example, fact, other and XX XX% improve, relative There’s on what In you on histology. histology. hepatic we’ve ultimately when so effects think I just particular, of longer with respect I of some certainly seen be as well that patients, these least early encouragement are of improve think dosing, providing about is range, for numbers over could the proportion XX% spectrum.

minuses about as will the studied population. targets So think various in I pluses patient cases. same parameters be our have holistically think the and various in different And entire I case impacts on think being to framework setting many around other the of the

Steve Seedhouse

Thanks so much. Appreciate question. the

Operator

Our next Oppenheimer. question Jay proceed with with comes your from Olson Please question.

Jay Olson

if in to for about PBC agonists. thanks my PPAR-alpha at EASL in in at PPAR-alpha, follow-up have that some I at it was data patients. PBC. versus of PPAR-alpha EASL. did for PPAR-delta taking provide And I’d a you – spoke other to, delta data question. And like on competitive reductions Hi, earlier was PPAR-alpha NASH. relative for the ask was was I thought there that some strengths would not data show, advantage wondering, you about And, where ALT That specifically

Sorry, PPAR-delta agonists, specifically versus PPAR-alpha?

Sujal Shah

is mean milligrams of I while at all. reductions reduce a inflammation that course, we actually phosphatase, bilirubin is agent this there’s I And disease additional an and having even patients has in normalization think actually patients Pol, of color? it in been PBC think key transaminases, physicians – alternatives normal. have preferred the don’t correlated question the Patients we I’ll saw course in is the are and inflammatory want for the start and, any fact an autoimmune baseline I liver upper that add there’s no to question alkaline would this mean can of profile think for in two lower above XX you towards endpoint about as inflammation our registration. study, only do setting. at and limits X and Phase off. of the in think survival elements primary way do in some treatment fact really elements transplant-free

Pol Boudes

I that the the space, transaminases portion PBC Well, that goes disease is just then invade of if want is the from – can digitization to what add liver. goes inflammation of the part you it auto show the lobular the

baseline this can particularly with having that normalize decrease in So transaminases, a that that transaminases parameter. patients in elevated the

translation you clinical important, think that, if I to wanted is implant, of very the of anti-inflammatory seladelpar. is effect and also

course, course, of to important EASL an have safety side at So also equation. with the side then it things, there then there I there PBC of a part one actually fact huge have valuation the presented motivation efficacy in an autoimmune was in you of And transaminases, was it’s [indiscernible] Then means the think might that that in was of lot the a which patients data more that arthritis the was remember on transaminases. was, drug, the that us of the I transaminases of update, was for for patient the patients. that elevation you of but say

taming the part it’s then transaminases inflammation with disease positive of factor. see with and the certain new really you So that

Jay Olson

about I expect for patients to ask also, And of cirrhotic cirrhosis. see would other to if NASH you’ve Great. then with PBC seladelpar wanted patients may PBC for specifically, Thank I recross in is seen you cirrhotic signal, of efficacy seladelpar cirrhosis in And there with causes efficacy outside and you. to the patients? any

Sujal Shah

Jay’s perhaps Pol, you Yes, can maybe question here. address

Pol Boudes

patients. safe was with to see progress you to drug first and and this whether think have I the see here. want you PBC want drug you step-by-step to answer Yes, whether data. the is need in start with And you cirrhosis you to question is What

response growth, save profile the So compensated to did and was which with the patients do than safety EASL cirrhosis we in seems not that data if patients the have, also, we the that where presented really much important. is important at have that it

potentially Now, of information, translate I this can kind think that. you

we as going disease. So, said, cholestatic learn, PSC going we’re is PSC. study we’re to another

are things. the this data for have side of So, that we certainly PBC PSC encouraging in

because question, efficacy an in also to you to we the important that’s you cirrhosis. want study patients NASH, also safety NASH go and Now, with – the if

they the patient that cirrhotic – etiology for cirrhotic data a bit you’re course, cirrhotic this do that is in not So, not patient is this encouraging. type cirrhotic resetting the the also in the and exactly patient is end, liver. place asked patient fibrosis, stop decompensated NASH. of in PBC although In the But remember to the of the important. very the decompensated are PBC information less in the the patients, same exactly cirrhosis, importance same

need accumulate we evaluate. disease data, to for we course, – of other we that So data and want more to also liver continue but that’s important will the have we

Jay Olson

very the helpful. questions. That’s Thanks for taking Great.

Sujal Shah

you, Jay. Thank

Operator

question. with Our Wainwright. comes proceed Arce H.C. Ed from with your Please next question

Ed Arce

wanted for your Sujal. the including my progress thanks Hi, offer taking well question. And to for also designation. breakthrough just recent congratulations all my as

Sujal Shah

Thank you.

Ed Arce

So, I continuingly and what program. be PBC, profile about and evolving wanted that of ask lead seladelpar appears course, to your which expanding to remains of

EASL we’ve significant in your normal numbers study data opportunity showing And actually ALP you normalize. beyond the the how one particular as discussed in previous at first area to PBC the in of of as to limit Child-Pugh know with X.XX that that gives A I affects upper that as well, both that comparable at that you market times look cirrhotic patients patients. well. as of the The non-cirrhotic last – comfort you’ll gives showed early month go well

as the PBC, how approaching – the approach market same population overall that be And discuss perhaps you or with the patient expanding you look the of others ultimate of so at that two could the time. three informing around would sort patient is commercial

Sujal Shah

Thanks Ed. that, the address to happy question. I’m Yes. for

and the well of Hirschfield. with We’re closely in group, Hansen PBC doing global bit Gideon as Bettina a fact as in fair particular study work

phos progression as being work of each focus we’re potential in that understand transplant patients going bilirubin course, to free from our really As historical survival. And And how the benefit disease of better of they’re thresholds these data to treatment prime at despite disease in of related progression a at a better evaluate seladelpar and second the and order of treatment. and on enhanced alk in continue fact patients, and for across remain we line high this may markers impacts risk reducing to do to look and that that UDCA.

the here a data relationship that survival. phos between really think and demonstrates transplant-free alk log there’s I linear initially

number you is will the of identify so lower the able phos, just range you not normal alk the really ability for for closer be what it into course, to the a And patients. part us, to bring has be of can potential significant the disease. benefit to important fact, seladelpar, efficacious, enhance potential you And symptom and with be the tolerated and the even as key patients in a well even normal as of to clinical improve but also into potential on only with mentioned, getting we’re bring it’s range, the looking very of the to for confirm a which

an be end, the important population. ways, I to of be parameters to that, in many think expand to ability considered the for can So, patients will very a overall elements the quality able patient really of be life in assess outcome,

continue the driven is that largely profile this expand both well seladelpar as efficacy of that’s ongoing to by may tolerability allow the population. to as work really the overall patient us So,

Ed Arce

with lot intriguing would of me this with you It clearly other you enhanced it’s then help timelines as you’re move forward forth with little to success related those That’s experiences, is of how PSC, other a points, indication? does that I study. the to now so cholestatic lead relationships, had that than us sites with and mentioned that great. still NASH the inform a to you the PSC just disease your and and question a which like third this the can wondering, bit have seeing around with And helpful. and was fluid, with rapid end all your enrollment closely believe leverage so

Sujal Shah

Sure. Yes.

accelerated in you the timelines some our early in of really plans second PSC each the key these to really forward data be to completed So the of of really the more the drivers here to internally Phase have ability and in prepared in dataset X around of ourselves essence March. things that our able to the setting forward. NASH we’ll activities provide the captured it specifics PBC the can study get with we in be move move recent with internal to respect – as year. But to We’ve study. initiate finalize eventually financing most this half here when of we data the this study quickly

we a recently already developed PVC. have all hepatology to running tremendous key as Additionally, given the the is and team the at Early of who VP members; individuals, setting prior be had a amount Rossi, we PSC in which opportunity us many company Development, Clinical study seladelpar experience really Steve relationships has have of his himself on most of of of front in has we’ve our

in have So, to we’re a move population. that patient quickly. key to need opportunity It’s unmet an going quite really

And with so seladelpar, into really far move PSC. to efficiently respect seen we’ve I think thus to our fuels what ability

finalized coming, And so in they’re some we’ll months really give you again probably updates as the here weeks to here.

Ed Arce

then one help continue at presented around, pruritus you Okay, to last of around being with perhaps question discussions done great. in does groups collaboration just DDW, may the regulators ultimate that with the work And if today work be posters other announced labeling? I how with and PBC, and one to

Sujal Shah

question Yes, start sure. in I some on want color add and Ed’s you end. to Pol, the do can

Pol Boudes

Yes. you Can repeat the question?

Ed Arce

from around going you’re you other at groups PBC pruritus, could data forward? with thinking some wanted informs are you forward how to coming that just how poster in the I DDW if on presenting you and see give are Yes. details more including

Pol Boudes

Yes.

feature we a goes – the show patients. at real So this interesting, pruritus are poster really to And for it’s with seeing DDW of organization. because actually, collaboration patients’ the it’s impulsive

on did the impact for what was to that So, to also patients. try pruritus evaluate the we to is of these to to pruritus way evaluate and measure try best patients

this bad So, have for very to good was feedback exercise. that a it collaboration

also significant of pruritus. in better a to in we is what So, understand terms change try for them

potentially, important information and inform, is So be of it’s about expansion itching pruritus alkaline with important, limited it itch also the that’s lab, also of problem very because that can to question that PBC and this phosphatase very topic could a in patients coming of alkaline having also are important elevated the – aspect, a actually have some not phosphatase. the realize elevation back but the do of seladelpar that to have that you

case. of while is always disease So the severity correlation general is in a there the not and pruritus between the

were So with [indiscernible]. work very be to we happy patient see able to and to

Ed Arce

again. Thanks

Pol Boudes

Ed. you, Thank

Operator

Our next Please Riley. question comes from your question. with B. Mayank with proceed Mamtani

Jeffrey Tan

Hello, This Tan Mayank. taking everyone. Jeffrey in is for question. for dialing Thank you my

realized prior PPAR any First could seladelpar points to delta agonists molecule? comparing you same would in color have fat point not ever report as of any the GlaxoSmithKline been helpful. back any day, to Was generations reference be such but in the reduction MRI-PDFF might the available GWXXXXXX? I modality liver data there

Sujal Shah

Yeah.

patients. I conducted a on compare there six that element. this isn’t small think only really very allows us study, data unfortunately GSK to a really

In fact, only that fat didn’t they were a liver percent in fat X% vastly range. X% elevated liver patients have the to

for I think very important didn’t but out few different in X-weeks, where liver fat. to that those number patients small of me of – see and, patients, did reduction point very elevated in a a So, quite that have profile particular and a they XX% really it’s

of really in potential I about think in the seladelpar overall potency and fact of that in mechanism more compound. GSK fundamentals similar to when seladelpar, the the itself this selectivity we as think meaningful terms it’s parameter, at very

points the of this the seen in key done on reductions Chuck encourage but benefits are liver of acid key driver think meaningful And, that course, endpoint. I with mice, as also albeit in around we’ve where work with this models seeing what as some some on some the we’ve has peripheral mouse really promoting as of us hepatic seladelpar. NASH, particular this in tissue, fatty fat mentioned marries various in call, so real oxidation around And in well well

I comparative fact because in a think those are is population really than GSK patients. the very things looking for and data again, different more I’d limited on with anchor of it

Jeffrey Tan

Great. up I follow have question. And one

pivotal readout data an So how in need you X Do NASH, think some the Phase namely X as are the along watershed for way? would of preparing you readouts two Phase XXXX, sort partner PVC. in readout you histology in the organization guys

Sujal Shah

year the really and of our the data NDA about to That’s team to setting that to question. to take this a I requirement In PBC, of and the here confident have own, very able the of in think setting us only hands really when profile in The a launch further there the forward as being good help ability on you bit execute us of X built Phase in the little for think we’ve of as patients we a seladelpar studies, prepare can development. file PBC internally the the in that the start all inform year setting overall. We us of Phase feel next will way Xb NASH the our PBC. clinical well ability to seladelpar carry not

Here we’ll be pragmatic.

beyond strategies NASH continue development is certainly and the exception in of in thoughtful team we every expand are the clinical Phase setting advancing no a of and setting X think around but capabilities we to always par have NASH, I to really seladelpar development

Jeffrey Tan

congrats my questions, a taking quarter. and on for successful Thanks

Sujal Shah

Jeff. Thank you,

Operator

Humphrey. comes Robinson Nash question proceed your Please next with Our Edward from question. with

Fang-Ke Huang

Thank our Fang-Ke team and the progress questions. taking to this you is congrats for Hey, quarter, for for for Huang the Edward.

exclusion ENHANCE Just inadequate in to be to subject OCA. to for as the you one and any realizing quick basically, program PTST for response are as will the – a criteria study, is Phase study real long OCA can X

point OCA, on percentage who who data percentage it be What data to OCA? the any switch data – helpful. percentage, have have are income enrolment, point but and don’t other intent point Thank patient you what are are maybe whether trial. fill? very enrol And not the – could you. wondering willing but of Just currently point to you and that for X And to maybe on to

Sujal Shah

Fang. Sure,

patients of into inadequate your the come let urso, OCA Phase UDCA, that second-line patients been basis for off the responders So as clarify population treatment. or or need are patients past, of on who otherwise in for me to they acid basis that’s ENHANCE some the course enrolling small the wash have had the have subset. study effectively. treatment OCA that We’ve those in intolerant can very We to X and first ursodeoxycholic

we some We that – vast UDCA likely But U.S. expect majority, yet think believe to fact, I – and that the patients acid. have will particularly cholic have as ENHANCE outside and the see into have still been only to see on come ENHANCE, are in certainly tried not of better a well.

real and give criteria to is bring I So make responders that sure any that enrolment you UDCA either me wanted to specific patients the hard numbers. or clarify to in for But ENHANCE inadequate UDCA. to and are to intolerant

Fang-Ke Huang

you be days must realizing Thank XX I treatment. XX actually [indiscernible] here that. prior Yes. in And the for or to

part. forgot Thank you. mention So yes, I to that

Sujal Shah

Thanks, Fang. for Yes. you Thank the question.

Operator

we the Sujal to closing question-and-answer call back Shah turn gentlemen, the end the I’d time. and session. Ladies comments. for reached like At of this to

Sujal Shah

we the promising this of again of you, joining one operator. our as in data everyone And very soon. including I’d to for the in tremendous forward as patient by Thank again of And you. updates and quarter patients, our this and we NASH. course possible that you today’s and data for PSP the by inflammatory here Thank their to development this pioneering PSC. and these the course busy continuing our in for We made of of NASH. important make the once point call. sure is in course year. a PBC CymaBay And of believe us expand far are and like setting me to start once families And year really thank well We’ve here for about on now seladelpar providing all already of thus of is had are excited first half most to second liver work of look compounds their forward diseases, active seladelpar it’s at out efforts with generosity excited only you think into look work indications, caregivers. to new I

Operator

This today’s concludes conference.

time, disconnect lines and your thank at may we your this for participation. You you

Cymabay Therapeutics (CBAY) 9 May 192019 Q1 Earnings call transcript