CBAY - Earnings call transcript Q2 2019 | Cymabay Therapeutics Inc

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Operator

Greetings, and welcome to the CymaBay's Therapeutics second Quarter 2019 Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Dan Menold, Vice President of Finance for CymaBay Therapeutics. Please go ahead, sir.

Daniel Menold

good and operator, you, afternoon, everyone. Thank that press release hope results business you've quarter had the view and to chance update. we financial a XXXX I issued second announcing

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

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

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

the and that upon are in believes many uncertainties and reasonable company materially the factors. due impact actual of to forward-looking based subject outcomes assumptions, the expectations and results from those could statements risks are forecasts reflected Although differ to such

as those from SEC factors materially that for the factors are release required set actual annual the or applicable no with company to events forth update any as forward-looking otherwise, in as The well differ risk press directed to future as statement the to a cautionary forward-looking set result and forth except information, obligation whether could statement today's Participants filed of in CymaBay's reports assumes quarterly anticipated law. results the new or statements. supplement cause by in

of or the rebroadcast property of the without and CymaBay. is consent prohibited expressly call recording the written conference is This CymaBay,

to to call over time, turn I'd Sujal. like At this the

Sujal Shah

countries driving half is patients or than thank registration forward at and us. XX Good in seladelpar across study III active more made you of and with progress sites. significant for currently first cholangitis, XXX PBC. primary joining afternoon, year, ENHANCE a X ENHANCE Phase we continents study everyone, global have this in the In and biliary

mid-XXXX. and track to seladelpar complete We XX-week currently are submission soon in targeting the results an this is year study period. line of treatment for completing the PBC the after And enrollment end by with top expected NDA on

The advancement energy significant of next and has and towards for the market the seladelpar of injected stage planning company. seladelpar the

pleased that be For as joining reason, us Dorling announced this Commercial I Janet Officer. couldn't week have more that earlier to Chief is

to experience over build to commercial executing and Beyond our to most in develop high-priority of clinical effort. is strategy a on important ideally is XX sales cogent years out and commercial plan, this Bringing suited implementation. for to commercial Janet our marketing goal a team CymaBay,

built Achaogen, product. Commercial Chief she company's launched the a Officer As first organization and at approved commercial

to advance PBC Genentech appreciate VP and at the life expect periodically us you for have forward Product leader. as sales to it for meet and and I plans as will there included the our Strategy cycle of her Roche, franchise U.S. to acumen, outstanding roles goal about of and course, for depth for for VP she works Importantly, to seladelpar our skills and and learn patients. leadership to her more many breast-cancer we Global with bringing be marketing going Janet opportunities

patients. given II anti-cholestatic, pattern study The PBC Phase the remarks a has demonstrated of has focus quite to have open-label that and effect protected XX paddled weeks our on is Seladelpar of date of my intentional, anti-inflammatory XXX results opening in treatment. consistently significant through reported enrolled

for has worsening only with derived exhibiting treatment. responder bilirubin, from the only causing the second-line the the seen without done also pruritus for endpoint or combine enthusiasm robust seladelpar rate is that signs composite but but total it Acklin approved phosphatase Our not and because as so

and ENHANCE pruritus may have improve to outcome seladelpar treatment be suggested profile, in PBC. using an that be preferred which us will was for as second-line the Furthermore, the seladelpar to II, in diary. for to observed potential patients with a Phase monitored potential is This electronic secondary positioned key the

the XXX now over confidence has long-term further experience patients the in in profile rollover extensions by seladelpar have into elected patients XXX significant and to bolstered safety of that two Phase a number II years. build continues out been study been safety in The our treated to for have as tolerability Our extension. safety of eligible a where we experience have

core be data robust in advance to Phase a subsequently, our XX-week X present results line data. will II expect publish Phase the the early goal in study to of of XXXX, is about top completing, III ENHANCE this results. set that the the provide year As from will we study of And

bile uniquely reduce directly the PSC liver NASH. inflammation like its indirectly of lipotoxic and the including in bioacid actions PBC cholangitis, potential injury, and I believe or those Phase macrophages, We PPAR in several seladelpar's Delta cells for with setting beyond of cooper sclerosing circulating PSC. I liver setting of steatohepatitis, on for is extends agonism other will in and seladelpar. PDC. by the described would in call of through seladelpar remind inflammation the suited and shortly precholesterol II program to one decreasing One, or NASH. to that Aand acids and Primary both lipids, effects active key through the development two and drivers nonalcoholic

stage fibrosis disease. inflammation liver X enrolled XXX reflecting baseline events dose announced our Let of high our advanced me line patients fibrosis This enzymes, now NASH liver from part top In their turn study data to study biopsy-confirmed interim of IIb early we ongoing X as Phase XX-week XX% NASH, with program. seladelpar. and over recapping ongoing ranging with or June, having in recent

blinded be we a reported in and and remains study in pathology, linever explored with pattern total noninvasive the with imaging. fibrosis. as fat striking reminder, liver to showing XX-week NASH a to minimal liver As line associated end-of-study top but XX-week biopsy pathology to reductions evaluate results enzymes known with The content of damage changes

a Seladelpar an represent resulted clinically and potential comment understanding pathology histological key improvement Seladelpar Alamein translate will with enzyme liver in interest in meaningful generated robust into liver of does the in markers weeks and ordered XX in inflammation improvement effects the is associated also our markets sister has at seen weeks. treatment and injury, including at reductions considerable ALT. XX

FLINT XX% was in pattern encouraging including Patients in of phosphatase improvements elevated It for receiving a histological AST, the decrease GGT see from for units ALT in into per milligrams association withreduction decreases GGT other in histological reduction mean over seladelpar of Obeticholic also seen have NASH alkaline it recently seladelpar XX, treatment achieve to published Data units of ALT histology. with patients. enzymes of with other found and that and doses ALT in XX context, liver us versus per To liter reduction consistent of published an XX or liter, an improvement XX acid respectively, units and XX, studies supported XX put improvements at were per milligrams. XX an a reductions liter of placebo-treated X in response. correlated of to the XX greater the analysis the NASH responses in in results study a

the inflammatory supporting and results key decreases LDL-cholesterol marker, favorable HSCRP, triglycerides as risk a included decreases weeks cardiovascular Other in at in as well profile. XX

to severity Seladelpar through drug. events related adverse milligrams adverse of deemed in majority safe be XX neither treatment were which weeks. was amortization after of deem up to be to emergent week The unrelated had well-tolerated X through events were drug. appeared XX to moderate to and mild serious that There study doses and to at XX, study occurred

liver total in this While and evidence second mechanism reduction we're at we markers of population PBC forward seladelpar's to We disappointed inflammatory weeks, that addition to liver by what establishing damage surprised with not disease. and in seladelpar a about logical in believe a liver a our benefiting known action. fat is encouraging serious to see look XX of of meaningful reductions NASH, supported

underlying is As portion PSC. inflammation primary of we and we II sclerosing mechanistic regulatory interactions of initiating or and my of final update, share to clinical seladelpar's medium- development fiber in by characterized inflammatory are fibrosis to pathology leading concluded XX,XXX the orphan seladelpar FDA patients activity destructions inside area PSC. turn fibrosis ductal disease PBC. the study cholestasis, PSC excitement high which with in cholangitis also bile and developing therapies. cholestatic no disease in diffused is ongoing large-sized for approved cholangiocarcinoma. this inflammation to are chronic had Phase to and the development the a bile need is rare high seladelpar We of liver, approximately the of by underpinning share at with clinical a disease Commander successful ducts is outside Patients cholestasis, U.S. and disease that in unmet as in some and cirrhosis. cholestatic our and announced a as effects it let me initiate predominantly that of disease. division there recently patients fibrosis advanced PSD an is duct, the risk and affecting with liver manifested

disease. more is heterogeneous generally a it Although

weeks. approximately sites underway, this will quarter. XXX dose XX alkaline will II milligrams Activities enroll at globally. and change X to patients to placebo baseline the study be ranging randomization. The well daily X versus X at The studied will study XX X patients will are [ph] screening with for expect X, phosphatase of relative at once XX outcome XX efficacy we to and in Phase to doses Seladelpar be that in be begin primary placebo-controlled the randomized

inflammation FibroScan, RI with exploratory measures, of biomarkers MRCP will and and evaluations, including endpoints imaging include serum fibrosis. secondary other including and Key contrast

seladelpar status global My the disease, well of registration the and goal in has been PBC. today for summarize to inflammatory path potential for down liver

team execute and to population. a proof-of-concept yet implement we're building improvement yet readout market PSC, we in the on second launch in offers and orphan extend begun with mechanism damage study await XXXX. well We've histological seladelpar's commercial And that potential have success. for patient believe franchise quarter continued with of NASH into liver and We now, disease embarking another to the to plans develop in fits cholestatic underserved our of our in signals out another

our at briefly plan and XX. June $XXX.X is XXXX. Based our cash into Turning fund to current operating the million cash existing equivalents cash, marketable we're expected on securities, projections, financial, current our to

and results the our the a filed overview months detailed refer release ending to SEC operating X XX-Q the X with for our June to today. press I you XX, will of period For and

the I'd for now like to questions. up Operator? call open

Operator

[Operator Instructions].

Cantor question first Merle today is Eliana coming Fitzgerald. Our from with

Eliana Merle

of tightly such as linked reductions not on, we to know that PBC. will I outcomes is as of long-term key class I give outcomes? metrics, color And study? on you're thoughts us bit lot a a exploratory of that more the just just your and but you Can what are PSC know you secondary mentioned predictive little at metrics long-term these PSC looking which be guess and out

And the Just there? curious regulators post well? thoughts terms of And as [indiscernible] what of your speaking thoughts in with maybe then thinks? these thinking your they're

Sujal Shah

question, Thank fact, perhaps I Yes. missed. PBC that start to for is, Pol disease. cholestatic and anything off ask add the PSC Ellie. you in like may I'll have a

phosphatase important experience, long-term. So the indicator at understanding overall of cholestasis that actually benefit alkaline very measure to part key expect of level we it least and patient's overall be is the of patient's a a and for

that PBC. there setting early in particularly, correct in fibrosis you stage as is, well inflammation absolutely of a You're degree fact, typically PSC, greater of see, as often the in

impact understanding what secondary we're both better host imaging is fibrosis as overall inflammation seladelpar of and of as with including the health. well get of wet so to biomarkers the to on a liver And do of looking markets,

space Now study. -- XX-month this this assessment to is in XX-week a

is yet So And providing an fibrosis. as potential described endpoint the of largely may outside while firmly fundamentally, that histology amount on to in to tremendous recognizing in both correlate endpoint the learn longer-term PSC biopsy impact these indication as inflammation think a where we'll are and regulatory these to some biopsy on overall fact hasn't us agency from we well uncommon, liver PBC all health. secondary there's date, of similar overall markers

Operator

Yasmeen Roth Partners. Rahimi next from Capital is The coming question from

Yasmeen Rahimi

for you. of So a questions couple

start PBC. with let's So off

ensure you built can second a what you have And ENHANCE about that of tell sort for on then bit NASH. pricing into seladelpar? me of type is high orphan more So little question PROs the

reasons is know placebo you then there I line, had I that, specifically that top around time nuances to have ran that we've some go a share And you quick learned with follow-up. probably higher-than-expected? So back like any to would why response to the

Pol Boudes

Yes, me, Pol. is this

PRO for So first the we'll the take part question of for ENHANCE.

hypothesis, using as we're using the now using our we of association our but effect And is main potentially and -- actually know, PRO to is done hypothesis do by scale seladelpar So beneficial going pruritus. a and internal only system which see the priritus, reporting that and not that to you we an electronic the confirm treat NRS pruritus the is we we not are patients. are between

way which PROs, using other PBC interesting specifically we because scale is PBC, know as XX you focusing the with in the an for what are has there's is this on one fatigue, really for For is main called it's [indiscernible] symptoms scale, PBC patients. and is it's which really which for the scale, lot been specific developed really of the of PRO, that pruritus a PBC is in -- which

a to key I pf are XG something for pruritus. IRS. the We But scales, on pruritus called going is would outcome PRO that's for study. but XG mentioned be is have using that's this we sales, signal pruritus, And pruritus be main going other to which

Charles McWherter

try placebo to our remain to fact, content. liver We're to weeks. we're because in the degree blinded a broaden continuing and all the the will We're study. in The to understanding Chuck. is effect, on This way still blinded hampered the study view fat Yes. XX

limited pretty the So much top group averages. line to

or be characteristics which of believe to factor things examine We like we a the were example, biomarkers to markers we population additional effects to interpretation weight psychological put look little on pathology, a lipolysis, to synthesis, on number allow an other focus will very for challenging until conducting NASH point, patient is association, acid specific key baseline fatty if at inflammation, and assessments oxidation, bile factors, of some there associated this level us with with at get see it's that but of acid it. is down also able data, will other loss

Yasmeen Rahimi

have Meeting [indiscernible] upcoming an us Can you guys EASL. into quick you Boston? into glimpse in should the and at Liver AASLD we give late seeing done be And amazing job what in getting a

Sujal Shah

the now taken continue we've advanced you've we'll a past think into this fall prior meetings, presence as AASLD our have to medical at I as years PBC. first from steps Yasmeen, few as over seen and Yes, us seladelpar we've as meetings. we've And key at NASH, including had

populations. we about to mechanism, bit various learn continue chemical We and a structure patient benefits we're in the think seeing seladelpar, quite how

as obviously advancing, Not PBC. So Phase continue all continue are setting successful from share too or shy what without making specificity until ultimately And in experience much community I'll to of overly to believe we externally our we it with filing. fundamentally, an the these well we that medical the to to understand continue but sure longer-term impact learned to details How we're NDA with as efforts far the see focused will we we're away But any ultimately, if determined around being able focus on thus III, patients be here seladelpar particularly, are through until if people of largely internally successful. specific. in seladelpar. we've just

we've activities holding getting to think been our crucial own really forward patients. to seladelpar it see of course, boards, clinical the to meetings, own but hands you'll of that active just So continue fundamental and very are investigator we our activities advisory our the move way from broaden, continue in experience about not ultimately at

Operator

next And coming from is Raymond Seedhouse the James. from Steven question

Steven Seedhouse

team talk you a out can had and commercial deliverables X based just on beginning to just almost NDA timelines? for submission Commercial Given and be that away term the Chief Officer PBC, near a the still priorities team current are would for about you years build given

Sujal Shah

Steve. commercial team through a effort Thanks to core strategy. for really to think here the an the is question, This overall build intentional just

that also treatment on patients. recently issues understanding second-line in data commercial overall understanding about causing worsening in and half has in the lead. the only know for the Janet the pruritus small the of based approved that be III on how really market, terms some a we'll been And only clearly adequate impact benefit tolerability as has Phase provides we will or needs, population So in a very patient here understanding front just team the deliberate

way thinking population and opportunities so for we with overall Janet activities not patients the that we believe nuances we doing of and the the filing the expanding to of the think is we'll best about that better approach effort strategy NDA as part patients and So part in we ultimately for of terms we seladelpar as benefit. the first just be will positioned but understanding as that seladelpar, hands continue ultimately in market what invest approach just get we're patient through to can and PBC in the longer-term that lead many launch will of that

effort very just on a medical Now specific focused got outside of and even we've commercial, affairs.

several we've that well are some as liver PBC quite affairs well medical really sells and have directors. field individuals know areas fact, been in also. these active of that space have They as made quite for In been individuals now the former time. These hepatology well. that key quite in the MS now hires are And -- space field

the great additional the well. recently up have team area some feel that we So built of members that about efforts in [ph] metaforas our joined

Steven Seedhouse

going has curious III as use of in more patients Okay. you has in type to second are Or the ENHANCE, patients over slowly Phase its you And study Are agent higher enrolling? of the and are those just has the at the enrollment the evolution speaking course impediment back to terms seen enrolling proceeded? OCA-experienced been that that OCA in of churn -- to it you've commercial line all? continues if I'm uptick. of PBC,

Sujal Shah

Sure.

I treatment. wouldn't seen cases been that impediment. the do and tolerate OCA able they're are make or on see say not tolerate to decision, able that have any many So we to patients not we've

think, tremendous an of of need patient. absolutely I alternatives treatment seeing continued the for we're Ocaliva of for underpinning strong correct. what the Part additional launch think with, I you're is

continue seladelpar efficacy have is And for think the a -- patients we And to our issues, as enroll to so both potential tolerability. in I deliver, of was a from despite population perspective, what in its continued well need, better which that earlier strong a very we continue believe very patients we our tolerability strong what as saw launch. as what I and see we that improved fact quarter to ENHANCE, has today everything

X, community very fortunately the strength for on has been to heels And of the enroll the is set as data study. we that our over been past that II pre-specified fueling our so largely data we medical ability with that presented years Phase us, Phase seladelpar, that's in III of continue the in strong ENHANCE X overall this timelines initiated to

I in So remarks in seeing now see our the opening Phase eligible treatment out And to of the seladelpar XXX to we today, long-term of continue mentioned that two roll extension, we to fact, are some XXX longer-term. strong study that we XXX of into stand patients those support. see the in II years. to many patients effectively elect are

overall, and of we to the in continue I ENHANCE, sales uptick fueling to see increase. largely to So it's scripts our where ability environment our overall and what fit Ocaliva think an enroll even continue experience for

Operator

next Our is Wainwright H.C. with Arce Ed question from coming Company. today &

Antonio Arce

couple of Just have a here. really me, been some questions asked, but from couple a

is guess little see some something that the PSC the venture fibrosis a of PSC First, obviously is that disease. in with regard to higher ulcerative there bit to earlier associated probably inflammation colitis. do IBD with has similarity I you mainly but would And course with strongly POC, with in

the externality, wondering of design trial? that sort impacts all? you Or you how the Just thought the of at about controlling all how think about that way if

Charles McWherter

Ed. a I'll Yes. This Chuck, at is take run Thanks, it.

to your So second. back I design I'll a in come question think

just PSC well. to PSC of I IBD kind co-morbidity of of with as about IBD and think the -- do patients have speak to XX% the

make I does the assuming bacterial think complex is I understood. incompletely IBD. and the But the on liver underlying sense there's component disease that pressure often a that think cholangitis is from it of current

run the PSC recurring pattern, infective diseases, kind connection between is described and common of underlying risk of the autoimmune likely of a two one inflammation, the the pattern well. Steve He obviously, Early incompletely to able common where as the VP recruit feature which So the before. MGM as is is We our came fortunate were of PSC characteristics the from because CymaBay study he'd diseases was Rossi a to Clinical Development. of us

exist being us complexity of to therapy able had have informed IBD, need to is kind uncommon of population population story PSC mentioned, population the also at those The the with to us you've and been been want IBD, population face that the at just that study the led any particular have the Will In lot to balance this to to for of desire in in that to we study probably end study makes by as being clean I have versus converts. of not think will to really able a enroll about who but endpoints. And the back measurable enroll a able of value IBD, the background the able because be day, develop effect expertise do able really patients case, a of that that's you just position. of so to practicality therapy sense experience to experience simple and that. a rate. a be the be design the on

less there involved time had these there the that will. to their clear represents like specification in study if about a colonoscopy protocol patients, stably really the investigators them that controlled. assessment use think you and But is need to you and don't of evaluate clear, the of managing very IBD assessment is be is the position, having baseline experienced I baseline So an in ahead then tools in terms episodes, they very

position well relative be specific industry. it's So informed that IBD to going and upon experience, to I challenges any Steve's we think there's don't think based

Antonio Arce

Great. Okay.

are -- for know question, on as a end yet. was that think know but the point one of how call. PSC on study any pivotal in I or absence particular registrational a the perhaps the if On composite I this, on endpoint But around some what would And terms guess, a endpoints, with in or and this there other about likely there's to last of maybe PSC? upon most I we of sort other the further touched work PSC, for going definitive updates in

Pol Boudes

Add, this is Pol.

is ongoing endpoint discussion III I is this Phase appropriate think the what program. for

part I outcome. when the a look the of people favoring I to And fibrosis, of biopsy bit tissue think PBC, easier this composite is some And of the you PSC for component as us really compared a evaluation at are in to it's part is have biopsy, little the think that actually. to evaluate that example.

I good a the good the thing which answer. also I The So between discussion and academia, a of for would FDA, there sponsors the liver authorities mention is kind discussion. have definitive don't very the this is program, vehicle so European is

when we'll will be So see established. it

some disease. to also outcome makes kind think it's of sense I composite a it rare because have

at concept you I when really is go us, size things moment sample it makes Well also the in III, a for So of important Phase think, what probably proof for easier is terms little of calculations. PSC. bit the in

are of proof-of-concept the kind in anti-cholestatic already effect have We of PBC. the optimistic because we

to an evolution. we'll see it's going interesting -- So be

Sujal Shah

add other guess think there comment that about to only PSC. I be I to a seems the that evolution would is

of in some what's in analogy sense to NASH. kind You an say could happening

think to PSC. about So cirrhotic noncirrhotic and

kinds endpoints. themselves And to so of those subpopulations lend different may

have you to the noncirrhotic, If you're progress to cirrhosis. potential

markers liver like towards be be But perhaps noninvasive whether which would are accepting that invasive an services an measures, blocking having something stiffness, measure suspected biochemical maybe it or or clinically noninvasive it'd something clear some a measure be that. like those a biopsy or very market along evolution lines. So test, it whether measure like and

what different but that interesting looking really we're some So endpoints subpopulations two I end that up might think those like. of in approaches terms represent somewhat understanding the

Antonio Arce

Well helpful. diseases for Great. from to rare a think a comment. always even going biopsy for bottleneck the helpful. Thanks is that's I would be is obviously moving away

Operator

next is Humphrey. SunTrust from Our June Robinson coming question from Lee

June Lee

liver [indiscernible] [indiscernible] that liver appears lack a reason motivation-related Phase a have to to the in might of the we've pivotal thought the IIb. were I specialists, they on press had lack you thereof have and study? if bit Both to placebo couple group. reported your on the reduction the Phase II we placebo a on hear data. controversy our contributed phase incorporated highly the recent It any of of thoughts maybe the actually the And run or follow-ups. reduction Love a the And both fat that? around learning positive in of expected have plans in clinic, And

Sujal Shah

Yes, at level June, can we it's Again, have that, it far we've be have the may think we possibility, group until ultimately great as a determine to placebo. for was observation. a I seen been I what what mentioned, to weeks. Chuck with don't for placebo think that XX particularly, data, seen will dismiss challenging so us patient relative

at on designs, think inform understand considerations XX study opportunity and we the truly completion of As study the the broken our for get seladelpar. seladelpar weeks of part for it pertains about And as learn will we impact around an have to of thinking in of each the forward III, Phase the to how example. the going histology course, everything we that to

types be the certainly that will of through. think To we bring things

I what conversations But see have improvement health we would with we and to on enthusiasm broad overall first want would liver a also in reduction. torpedoes Absolutely not see tremendous the certainly otherwise fat an a your to think point, as disappointed weeks. somewhat what amount with we group at of and we XX respect saw of surprising in is total histology. a manifest ultimately an related improvements improvement do in and see you of to see that indicative to

we've GGT, ELT the of consistency, both see and their so business a enthusiasm a most as for liver sensitive The the key these being far significant enzymes, are really what the to manicured, we've And of things latter weeks. amount with the marker I seen continue order that of so seen, vision XX stress. which the very we to encouraging think dose the that at oxidative well respect drugs as

define to in saying how we clinical completion will development study forward. the continue we'll going and remain help on focused ultimately early point seeing in So about very think that

June Lee

me correct (sic) and I'm an programs, cTX getting between still you your of correlation that? at what XX please on cTX I'm quantify on there at weeks. able mentioning method And speed And and histopathology? called I to noninvasive baseline share wrong anything but as Great. inflammation kind using recall up if Are you to you

Sujal Shah

CTX, multiscan. patients and And this better of implemented MRI perimeters one in that's of that be each coming technology get seeing from try biomarkers Perspectum multi-pair additional liver the II idea at the to a of of from weeks. yes, the a for what Phase Chuck far metric XX call mentioned, study. that as thus is number to ultimately we're will assessing We've

So to you in We across a as seeing continue inflammation everything as what pathology thus we far the it we at ultimately including these still overall perimeters, a imaging. and of to records think it fact, -- some be can year somewhat it multiple can is and picture noninvasive see only measure of other look informative what of exploratory, biomarkers, we're cTX. through it quantitative mentioned is, noninvasive

June Lee

dialogue entire meet Or Will FDA? on complete lastly, for with will what plans And III started data the are with or leading XX-week you to Okay. with Phase the prior wait SBA have before for you them of you already with to the the you II end your study study? hand? Phase the the

Sujal Shah

No.

we for the full I think we forms We'll Phase basis histology the and histology wait get have regulatory out set the III. data the II. to of the until again from the in Phase given for endpoints plan ultimately, end we do We'll go agency study second year. for histology and next have data quarter the the meet with Phase expect of that before IIb

Operator

Instructions]. [Operator

coming Our from B. from next Mamtani Riley. question is Mayank

Mayank Mamtani

progress. on Congrats the

mistaken, not PSC. asked any If on of is, reason September. workshop is now there have guidance there learning a document back And standpoint the is in I'm I that number trials. a only that Just from from we other a regulatory

in on on more think you is of have understanding And that also mentioned more end forms then is advanced my and the that I in progression, others driver disease. the of PSC Gilead cholestasis a it. worked a

in built the what you talk -- screening could you about comment maybe of maybe So study? on really the patients

Sujal Shah

forum I'll liver and way Pol been efforts and specifically ask I'll forum. of PSC, a to the that's outside Mayank, by on ongoing answer focused comment of patient and specific PSC Sure, part Yes. the first centered called forum population. the the on There've

Pol All with the towards clinical and group at thought alike. As year. it's regulatory thinking mused individuals the in The once endpoints it respect least the and from includes as dialogue industry PSC. about twice designs ongoing in agency effort. an or leaders study as working been of mentioned, well setting

it That works guidance type the organization released in fact that of that's hasn't does been PSC, through. typically group specific but the been the clearly, will group yet continue. the by the and ultimately think a call, On

that develop So population are we expect enrolling? thesis and continues the question you to and cholestasis around PSC part point really at we the to can understand here. second a Mayank, repeat the about of and with think been, to continue will see the involved it how dialogue have to in time as something the will group would be but be and in some respect

Mayank Mamtani

cholestasis disease heterogenous my Yes. Sure. advanced the drivers. is have underlying population forms but just a it's died on that Obviously, we as the understand the more understanding bit,

you are Just that? know versus Or advanced? planning of standpoint, on maybe I you less from enrolling PSC enzymes? Is are advanced measure patient other biopsy you it And selection don't like a how measures liver thinking? forms more maybe

Pol Boudes

It's Pol.

you that. terms are different ways of approach in So can there advanced disease,

to complete me creates population really patients. non-Cirrhotic the The be study of to I you want if will criteria. roses. severity -- the it and first have degree evolution we're going different announce in exclusion or think a kinds cirrhosis to Because inclusion, is

it's way we're really One thing. is controlled that's in company patients. the fibrosis patient's general, it also of factors. mentioned nice liver, We do a that a get evaluate while potential in look which are for the who basically IBD, new offered scan, studies, one would tool, Chuck the they in terms the that are to call at the previous [indiscernible] way have doesn't that's and to to going associated get relatively and called in also on that study BML seem IPD, are patients which also but and So cirrhosis. based

to So the nice goal. control way speed

requesting what are In level. to to a bit IP of from terms in be is city-based AP is we different done little PBC at recruit on AP What we've will not the should levels, baseline. of the so patient the that in evolution cholestasis, we're to going buy

AP a PBC by last the period. is points, similar limit the will the than which have screening they the activity be that European. should we pretty during And of is So level the

also So which we you PBC that's what cholestatic are to enroll disease so we twice also than bit convenient when start because also. doing high way to exclude be this little patient is a the in upper the are basically patients different level normal, population bilirubin of who were a in will up limit above too

Sujal Shah

and would very add thing only of with The for diagnostic client contemporary and studies other geography. as this the common the staging I it patient's is

in they dominant stable of imaging to also an different make that they to disease structure. a legacy like small but available use are of structure at dramatic imaging the biliary is tree one well, characteristics sources focus and a there also type available to look PSC used have characteristics on you possibility that, terms for of extrahepatic. commonly cholangiocarcinoma and one the dilation thing, for And sure that and of because versus and the few reduce -- segmental and to also have So to appropriate look

the for and from think in and approach I So population. focused noncirrhotic I think in course have we're also input Steve, this is contemporary of selection Ad there available best and patients Board, -- the most of modern on getting information, appropriate we KOLs

Mayank Mamtani

these screening relative bilirubin baseline the that, for higher If to squeeze and criteria these know levels or you a outflows are are trials? a I can PVC band, have -- lower and follow-up to it's I

Pol Boudes

to the general viability can patients have have look compared level clinical in specifically PSC It's trial PBCs, to not you at to make in in if studies. to the phosphatase Pol, studies phosphatase. of sometimes higher But alkaline I involve in the alkaline a PSC more they also and study statement related to tends tend

see I what more or but the So that a bit thing. same this patient we're in expect be to than on expect get higher going comment PBC. in would be We going cannot really levels suppose we is it's what to the going less market to

Mayank Mamtani

on are and on your there on sending Great. penetration caliber earlier inner that maybe in the with patient the strong piggybacking And mean, and conversation Janet are a then is disease? any today just and on and -- the board, diagnosis streams there any In work results words, the previous, an are requirements earlier inference I rates we other sign population? that to make improving

Sujal Shah

observation, Mayank. good a it's Yes,

Part little the time this spend are symptomatic there of are let's and are fully we'll understanding course say are Of population. of that undiagnosed not better times population But bit symptomatic. at many identified. yet

bit spend the firmly efforts population of believe in treatment and PBC growing. the and to we'll fundamentally. additional undiagnosed think raises continue do to helps fair time. part we observation. patient one that's good fundamentally a It's having In I So that will patients. that increase a for awareness the But is of that need opportunity see of why

Operator

We comments. or session. over reached floor the further to back any turn the I'd closing end of our for to like question-and-answer management

Sujal Shah

company data a get news disproportionally when with upon I'd Kevin. today external on focused few that I often single as lost is a important think we the single point event. attention touched to or like just you, Thank close points that

thus for alternatives in for same these to discuss we're same need we've to III and both First, a believe in the best doses what treatment same is and significant today. mirror improved point. same far treatment believe as deliver we II, patients positioned continue seen efficacy seladelparis tolerability should duration the Phase the population PBC there We across studying with the for seladelpar patients, our of where we've over Phase improved

Janet will to has and work been to effort the addition program. the this continues solidify decided the strategy to that focus to patients seladelpar the maximizes patients, and PBC, team, of to of be caregivers advancement begin central all delivering Our with and supporting on and commercial with their a senior

this a And settings year. weeks anti-inflammatory and liver anti-cholestatic Getting the forward it's finally, market Second, therapeutic parameters, generally fibrosis. with next look multiple given excitement and disease. today. NASH including only markers on with again effect include liver about X learn has medical could seladelpar tremendous once striking about the histology effective key of far, and to in and effects patients article inflammation treatment, that What cardiovascular a we we on seladelpar IIb We continue regulatory Phase our study along the with amount we second enzymes of that over target whether in a given exist designed well in a treat to and seladelpar the treatment to the candidate from and of as meaningful XX-week is biopsy of week was quarter the moving for thus risk we've outside field, access working met the the tolerated. effects the to the faced is more and alternatives far ways seen most endpoints, profile clinically but effects do PBC, others in to the consistent across we've market and of XX sport XX multiple approved PSC. observed NASH forward has the with resolution of seen data quarter us seladelpar injury, no leaders, this of improved a we study

We will.

activities the the the end remarks joining. further again on Thanks we in look for highlighted providing execute in discussed to here opening we've forward today the and to we updates continue As that future.

Operator

Thank today's disconnect you. day. and thank we lines have today. you your does conclude wonderful a this your participation time, for That We teleconference. at

Cymabay Therapeutics (CBAY) 7 Aug 192019 Q2 Earnings call transcript