Earnings call transcript Q4 2022

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Operator

Good day ladies and gentlemen and welcome to CymaBay’s Fourth Quarter and Full-Year 2022 Financial Results and Business Update Conference Call. [Operator Instructions] Following the formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the company’s request. It is also being webcast live on the Investors section at the CymaBay website at www.cymabay.com.

And now, I would like to turn the call over to Mr. at Counsel General Quinlan, CymaBay. Paul Thank you Mr. Quinlan. proceed. Please

Paul Quinlan

full-year you you have and release issued quarter afternoon updates. and review good that hope we and fourth our I everyone. announcing financial had press results business Thank the operator, XXXX a to chance

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

Stuart, are Menold, Joining Research Chief and & today Chief Chief Officer; Officer; Dan Sujal Lewis and Commercial me Finance. on the Chuck Executive VP, Development Scientific Shah, call McWherter, of Officer; President

the open will for we Q&A. remarks, prepared our call Following

Before manufacturing anticipated Q&A and we to regulatory statements cash repayment plans, like performance, remind forward-looking everyone this conference release or that Private during and plans, begin, as defined I’d schedules, funding to under future statements approvals, Litigation XXXX. timelines call, session commercialization expected of and Reform the events Act clinical made including are CymaBay’s prospects, planning data the for Securities dates, business including runway and relating

statements new statements in to differ materially as Although CymaBay subject to could and and update believes forecast forward-looking results uncertainties and actual forward-looking to that on reflected no risks the a are factors. from obligation as of the such supplement assumptions, outcomes, or any result applicable impact assumes or otherwise, events law. many CymaBay information, of reasonable except are due by expectations future those based whether required

as written of any or This conference without prohibited press anticipated the those CymaBay’s are of rebroadcast as statements quarterly cause directed today’s statements. is with that reports forth risk release, annual call filed factors forward-looking SEC CymaBay could materially well expressly actual Participants factors property results to from cautionary differ forth consent and the the to is CymaBay. the recording the in and for set in set in the

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

Sujal Shah

seladelpar you in and primary our and and in creating afternoon Phase readiness X Good Paul. today. In or manufacturing for go for progress its PBC. we significant thank our program our market finished commercial biliary parallel, XXXX cholangitis establishing infrastructure to for with us plans. you, patients pre-launch joining Thank were We also with

through potential science on linked in improve Importantly, long-term its biomarkers action and transplant-free effects our to disease, understand seladelpar's symptoms, of delivered presentations treatment foundational publications on the for and to literature improvement commitment in we confirming on survival. after the serum

we by raise needs on million valuation. end balance seladelpar rights months of By results January, in planned expected the of sheet by We laurels blocks Japan with XX had We at operating XXXX fast licensing our upfront meet third line Phase XXXX didn't cash X $XXX XXXX. our those RESPONSE providing favorable top accomplishments. strengthened to came in the out a capital beyond of a with our significant quarter followed closely significant rest cash, to over the

In of stage short, product. XXXX if placing we've execute our us first NDA to the on approval of an successful, by to the And submission. objectives transform doorstep on set company our the potentially

advancements substantial all be financial and clinical to Our with key to seladelpar patients the seladelpar in business development value position to and necessary for creation support growth around our remarks patients, organizational updates today will of on centered program focus prepared stakeholders. for bring focused company's PBC, of

most conducted ever are global core our the and clinical robust of programs development for trials, active two that clinical of part of activities, with PBC. patient one the At RESPONSE our ASSURE

and AASLD progress today start DDW, ask EASL, the overview Officer the call I'll activities. presentations President with and clinical on our the latest over and at year, Research Scientific year Development last Chief including Chuck accomplishments of to our and McWherter, an past of development made

our growth progress, patients clinical critical necessary lives clinical seladelpar by to organizational PBC. defined program the year with at effort improving transition and of infrastructure of aimed importantly to was commercial a the the past addition to In enable

to filing; Kaken key with that cash today growth business efforts development balance partnership catalysts our positioning to I second with NDA of and enable beyond our in a will sheet and in runway Japan; about half us this speak led the quality CMC, priorities year. regulatory,

this outline during of will call XXXX continue before ask end fourth Finance, of will taking Commercial Lewis quarter the XXXX to provide Officer our and I Chief Stuart, planning today's in and progress our that VP Menold, Dan with an our will overview also financials pre-commercial in critical kicked-off We'll questions. full-year who through year. Chuck?

Chuck McWherter

clinical data to Thank patients marked meetings. our made safety. efficacy by accomplishments made well-designed you, progress to with multiple development to tremendous The three important in We at seladelpar commitment and we through its medical PBC, reflects and understand in presentations studies XXXX Sujal. bring program our strides made key

of We payer, all regulatory, medical, and cholestasis, the of most our importantly, the injury, markers to believe including that patient underpinnings mechanistic understanding confidence liver the the stakeholders, investor observed gain communities. and on in improvements date pruritus is to studies and vital inflammation,

imperative In addition, oversight We medical on in streamlined our development XXXX. in and affairs. out our simultaneously Filling seasoned in decision enable biometrics, function goals capabilities, and talent and our recruited and seladelpar and making. while of R&D quality, we clinical was operations, to executing organized the development, R&D manufacturing, meeting an regulatory

and the site the study RESPONSE, the drag research globe, registration across As CymaBay variants mid-study aggressive mounted The on about X recruitment hit team personnel a investigator global White-Glove execution conducting of interactions our face-to-face the on seladelpar in the an significant Phase meetings. PBC. effort of ground road sites, from Omicron clinical focused with we visits created with for XX

commitment recruitment ursodeoxycholic eligibility X:X XXXX, our meeting investigators. the end our that hands-on we patients By or demonstrated seladelpar communication with for or the of inadequate provided XX were worldwide two-way response to intolerance to XXX visibly daily enrolled an milligrams July of criteria to patients network acid, believe of randomized solutions study oral We the placebo.

study this data in from line of the top report third to this year. quarter expect We

open-label extension these prior the studies daily. across also we our over XXX and XXXX, In that includes today once from ongoing progress taking response from studies expect patients our two we to plan and made program, study significant clinical anywhere years Inclusive apply advancing we unique ASSURE X seladelpar will to XXX have majority experiences, PBC patient of years by of which on experience of between the regulatory approval. development over time X for had to entire seladelpar have

participate We of with a significant believe providing their at elected that that meetings major to it, seladelpar. prior encouragement with significant regarding along in studies in another patients prior ASSURE three presence is medical of a significant aspect experience majority to had proportion us We sites from XXXX.

an Diego plenary Presidential we’ve impact of survival Week in had on Disease on the the predicted San after oral At presentation last annual May treatment. Digestive in session the years seladelpar held two of

received that distinction of We conference also poster awards. had two posters

obeticholic One with safety with response with presented prior cirrhosis experience of in other the and and of patients fibrates. pooled analysis and compensated examine patients the a on biochemical seladelpar acid effect

result held of Professor At anti-cholestatic part, through synthesis its the California described explains FGFXX This an Schnabl Diego. bile London delta in was EASL Bernd our from suppress studies least oral in effect. at meeting to acts by June, The PPAR last one conference University acid in upregulation the collaborator, in of presentation by hepatocytes. main our seladelpar highlights San established He

established that as of bile Ocaliva. seladelpar via FXR suppression than research Importantly, his pathway of is agonists, an acid different such synthesis that entirely

reported pooled fibrotic this thyroid than in And a detailed in an meeting to hormone at Additional without compensated beta mouse where with Both patients greater reverse analysis mechanistic of FXR disease. safety agonist and a liver comparable and seladelpar’s a established agonist. injury provide fibrosis efficacy for development investigation, are FX in models, for cirrhosis. ability to either it of which was active found presentations receptor in

PBC. Liver American Held year by in had Liver in November Traditionally, of of DC, clinical Meeting two of results new seladelpar flagship is meeting Disease. for Association us for Washington the presentations we hosted the in last

pooled The from first of a lipids a and studies X on ENHANZE poster was in post-hoc open-label Phase seladelpar Phase reporting PBC. X the analysis

PBC with patients. XX% had The PBC for PBC X and how milligrams seladelpar cholesterol affected X total Dyslipidemia levels, were with XXX were LDL understanding daily lipids we in in in lipids analyzed and cholesterol interested XX feature in a and receiving treatment X, these is months. patients X, Changes with normal of elevated PBC patients at levels. or were above placebo, with so of oral by milligram being treatment XX% dyslipidemia seladelpar common majority

seladelpar is a on for treatment were Seladelpar significant cholesterol in were Metabolic dependent not. profile patients therapy, decreases this dose the the and in those is for risk milligrams similar encouraging a seen and versus common total resulted those in who background thus far of aspect. to population compared characteristic of this XX these And these in lipid XX% approximately were LDL effects changes seladelpar placebo. Interestingly, taking cholesterol.

clinical chain oxidation, reduced and including in Metabolome mono the team ENHANZE dicarboxylates in serum carnitine, inflammatory decreases completing of broad acids, X,XXX diacylglycerol, acid analysis changes by an Serum fatty beta XXX in carnitines of Sphingomyelins. study. second dose the long Seladelpar increase of and indicated describing of to found research analysis reductions acyl metabolites. mediators, in made markers Ceramides and fatty survey was A months significant was dependent mitochondrial by increase and of lipid peroxisomal three presentation serum patients and unbiased eicosanoids, This the the and of found treatment CymaBay levels

reductions line dose seladelpar’s intolerant in impact seladelpar in clinical on PBC were serum seladelpar as to the first of to peer-reviewed population, with mediators. X as results the PBC target ursodeoxycholic published. study add-on XXXX, known Measured as to mitochondrial Phase evidence patients ranging XX-week monotherapy function, therapy In in acid our or two provide the receiving of well of patients publications from these important adult UDCA inflammatory as of results

studied Author serum of of on X.XXx or patients And describes liter. milligrams patients were present published XX% a the enrolled upper phosphatase of these Cirrhosis increased Bowlus XX% patients the had with normal response baseline. units if needed XXX Hepatology Seladelpar XXX of alkaline X, liter. was units and The excess be Professor up response. X, XX to could average to limit with the at first for per doses in or minimum Lead paper XX-weeks, improve Chris and the pruritus level treatment in milligrams Journal at which XX of after per was in treatment

XX%. pruritus of was were cohorts normalization in There XX, in milligram response serious discontinued rates related due biochemical and and and X ALP XX% events. the visual were X scale four patients the and XX events rates randomized cohorts. and these treatment to analog milligrams adverse milligrams XX% XX% patients ALP no also week bilirubin decreased initially composite adverse XX At and milligram respectively. in were The to

with patients XX last and fatigue pruritus, A the seen year reported study treatment. on cohorts this in in in moderate treatment X pruritus in symptoms improvement through XX% and severe reporting paper seladelpar sleep, to print companion one-year XX% patients in was liver of of appeared In the respectively. and patient pruritus, international effects milligram of and of milligram substantial

those was patients of reported XX% reporting Improvement total scale results itch using questionnaire. the patients one-year, the in worsened and and the improvement one in XX% substantially the at XX cohort disturbance sleep sleep year baseline outnumbered who score XD related and by disturbance milligram PBC-XX X in itch with sleep the After milligram fatigue similar questionnaires. domain XD of itch PBC-XX in itch the those cohort with

XX the of symptoms and CX in Improvements Phase had for of in were in X and have reported liver the cohort patients controlled reductions bile which patient up in generally ENHANZE treated we acids. study, confirmed Seladelpar placebo in significant months the publication. precursor bile at the serum biochemistry milligram acid XX% in submitted XX% to reductions now serum cohort X three XX% milligram and

we opinion advocacy scientific medical as recognize team to engagement PBC broaden Sujal? and leaders, our our healthcare want effort groups. with providers I increased key Finally, other affairs to our exchange and

Sujal Shah

to supporting of to goal Chuck development vital future strides number I'll important progress Chuck. PBC, patients with that seladelpar success. are of to progress bring you, with great made in walk areas that clinical highlighted. along Thank We the our our a overall through

help can outside development the business on Europe focused patients in beyond who geographies ongoing where potential our U.S. will studies have to First, required. bring clinical our particularly evaluating around seladelpar us and the additional world, development be been activities partners

announce a is Japan recognized in Japan. PBC on to Kaken thrilled medical were industry to company pharmaceutical and of Kaken quality of life focus with in we January, commercialize strong history seladelpar for improving scientific a patients with pharmaceutical partnership patients. and develop for and innovation a with in our leader the In clear

payments $XX.X and for to million $XXX.X net an exchange exchange billion] totaling commercialize, license In the potential up develop, of rates effective [ph] of [ph] in exclusive PBC, achievement seladelpar in and sales at and milestones for the Japan certain receive to to royalties. regulatory market milestone approximately payment will CymaBay [XX-plus percent] upfront for million current received [JPYXX addition

who development, approval, better Japan. for second-line partner for responsible be approved found a commercialization and PBC and potential will significantly regulatory the this treatments advance. We shares are our of currently our are see Japan. PBC values seladelpar for Kaken life work and and in have quality in of no improve passion seladelpar care with for to could There patients of excited to not

program activities quality to related and functions crucial clinical Key as progresses. CMC, development regulatory all are our

successful gaining have safety clinical of are for prepared to at And the efficacy supply we we in approval. be confirm regulatory ongoing studies. approval teams been should our and ensuring file Our regulatory that to should we quickly seladelpar profile seladelpar

overall our on-track success program the remain to as progresses. These and to efforts our objectives us vital accomplish for are

has important planning. pre-commercial very Another work stream been

call to Stuart, area. Commercial this I'll to Lewis our key Chief outline initiatives now the hand in Lewis? Officer

Lewis Stuart

Sujal. our within assessing focus region prioritized you, was Thank to on and geographies. global research while XXXX, foundational market seladelpar’s analysis market commercial conducting In opportunity

market all stakeholders, across while research key profile. seladelpar's global evaluations PBC current providers treatment and also product perceptions of versus both patients, healthcare PBC examining target secondary Our primary included including

It we in each proposition, landscape U.S., as Europe, for a the the Japan means was for optimal conduct reimbursement coverage geography. market equally important and access pathways value regional strategies, and that defining research

U.S. a based where we findings, As summary PBC you our insights September, I a highlighting may from in Analyst recall research. our of held shared Day,

have core mentioned As our our call, patients, last access to in and during development these patient insights of of goal widespread seladelpar. upon with payers from achieving healthcare global earnings aided imperatives providers, the I strategic the approval

essential In developed driven laser share innovation. our utilizing by CymaBay’s be like today we model stakeholders, the QX these plans. would a commercial themes touch PBC high will some market go by of and supported I that is from global And to its XXXX, focus initial on rigor vision, to engagement and a scientific strategy.

support pursuit but improved Our potential patients. this to coupled demonstrate enriched the of with health partnership with healthcare an outcomes, is professionals their life, of PBC quality to

burden. seladelpar, the success the of ideal PBC and begins achieving for alleviation vision of greater in the with potential patients a along this goals science Our treatment portion of experiencing its resetting with with for normalization, symptom biochemical

journey. opportunity, stage Our confidence an results market PBC new expand goals patient's could in seladelpar's clinical a Phase research previous significantly paradigm. future shows Furthermore, PBC that second-line for becoming these of each the while optimal from treatment our changing X of overall improving the us study treatment ENHANCE solution promise gives

You ALP both rates recall responses in moderate other safety demonstrating these, improvements in ALT, observed higher efficacy measures and patients. biochemical and we ENHANCE compensated that pruritus for well as severe significant in and non-cirrhotic cirrhotic normalization and will as to

to and theme seladelpar's compliance. second access maximizing A success patient be will

indicates in seladelpar consistent recent years, research payers analysis similar coverage. Other our of that in seladelpar's acid. landscape improved profile of experiencing access not coverage confidence if for market reflecting U.S. Our reveals over target obeticholic product preference OCA

Moreover, the many eligible enhancements the out Medicare patients drug provide tremendous in including of announced for pocket relief of elimination recent could in cases co-pays. monthly cost, coverage

a of development overall model high-touch as each patient's to their be service support designed access well will as to treatment Our experience. seladelpar,

engaged announcement expertise local will actively example prioritized strategic by endeavor discussions our including Kaken go-to-market in plans and seladelpar markets, of The is in for theme this are partnering other of value regions. the with of through third leveraging U.S. A in ex-U.S. Europe. in be Japan to we our maximize collaboration partnerships an recent

fourth to financials the the full-year for turn and Dan? over to now XXXX. our me quarter Dan summarize call Let

Dan Menold

Thank you, Lewis.

during the ASSURE on team our the enrollment and executing on have enrolled patient resources the phase focused highlighted, the treatment As XXXX, of response we study. study fully others continuing of

activities also to other late regulatory seladelpar necessary complete continue advance We PBC. our and in required of stage to development clinical

to where plan And seladelpar finally, potential progress well we in of as for we further launch PBC. continue made and in commercial affairs medical manufacturing, in and future prepare as

as further our equity XX, with of December a From finished $XX.X the a of with equivalents, payment cash year investments upfront from in following strong We financial million perspective, we January Kaken public of completion collaboration offering. and a XXXX. receipt $XXX.X balance position totaling cash, million a XXXX $XX.X the and the our enhanced cash sheet million

investments our together the Overall, of in cash plan third and to we XXXX. believe will received payment our be proceeds with and that operating on-hand year-end upfront the through Kaken equity quarter January offering XXXX sufficient fund

in respectively. and expenses a million XXXX December were to fourth our expenses lower NDA now development July will the RESPONSE the and development in due primarily operating turn of X XXXX the quarter XXXX, and enrollment for Research million to other spending than phase in studies. XXXX $XX.X the $XX.X I and review Phase Research were the of clinical quarter completion enabling results. and ended ended quarters December full-year lower trial of and XXXX

expenses Research $X.X higher these for $XX.X ended a the due $XX.X in XXXX million respectively. were added rose and million million, December and $XX.X were as which to we costs, and our by in was research external and personnel XXXX studies development million expenses development and Overall, internal XXXX years and in other CROs, development slight CMOs, clinical stage in internal increase to costs This costs offset support in vendors. decline our partially preclinical to related study PBC. a late to clinical

to lower during these of $XX.X spending external completion to million, of and development other RESPONSE the XXXX. in decreased enrollment clinical Specifically, the million studies due costs by primarily trial $X.X

expect PBC, the overall stage expenses in we development future. research to progress in late development to and increase As continue of our seladelpar we

$X.X ended the December years quarters XXXX respectively, $XX.X to These respectively. briefly and and XXXX for $XX million December and and of review were now XXXX ended general million a expenses. for million and were XXXX $X.X the million costs Turning and administrative

administrative expenses ended General corporate periods and XXXX the the in growth. higher of to personnel than support additional to were the due XXXX, corresponding and primarily our year December in quarter hiring

XXXX net the was loss years for ended for expense an than net $X.XX and general million primarily and increase expenses, interest respectively. research $X.XX $XX.X respectively XXXX, an to financing in share the and and for and or development million our development as December our increase loss and loss Overall, and share was million and XXXX per $X.XX agreement. administrative quarters December ended well full-year or XXXX XXXX per the $XXX to $XX and million XXXX due as related $XX.X Net $X.XX and was in net higher Abingworth

our expenses Overall, as we in future operating expect for continue execute our to development seladelpar and we increase the to PBC. plans

now me back hand the Let Sujal. call to

Sujal Shah

not more We Thank CymaBay. ahead about be could year the you, excited us at Dan. of

with more accomplishments, on While we are being as our much proud in to innovator PBC. of of laser maintain a an the improving of we have patients ahead us, our lives we focus recent do and leader

We key regulatory and program here X have at affairs and a in initiatives and Phase submit cycle begin assembled to committed team medical approvals, our bring also CymaBay but life pre-commercial completion management. to talented to planning for

PBC in in continue appreciated. seladelpar’s believe there benefits invest also to to that to and fully understanding be We potential effects is its yet have more

well-equipped to since in advocacy Having come. worked an innovator in with years we believe are patient healthcare groups XXXX, to providers we for disease this and be PBC

our We at all as stakeholders, patients. their CymaBay importantly are we transformational grateful for of a for year approach partnership most ahead

take Operator? questions. happy to now We're

Operator

Rahimi Instructions] Piper our with Please Thank you, And of line Sandler. question first proceed. the comes [Operator Yasmeen sir. from

Yasmeen Rahimi

to Good looking and on and for forward questions the great all congrats you. we're afternoon progress, data. team, Few the really

with is forward the feedback how as than rather [ph] the [Xx normalization PBC getting entire One X] community [indiscernible] X, is have speak alkaline of we the upper PBC limit. moving we towards been

does that goal? market X. substantially moving So, is to maybe with market love updated question the towards terms – percentage they're that, increase you the would of will what ask that's bucket that sort have And then of, forward I So, are going size? guidance research the in because some say if on color physician be know, or what obviously the of how written to your you community

the be that we're is, certain recognized really dose cons third the you, reduced but and and RESPONSE, getting could weigh provided I'm we have then Sujal, context interests strategic after is, maybe a that high expedite maybe them. high And was M&A the queue. data? that Chuck you been how and versus continue or nuances? put service enrollment, the question to regards one in through X a ensure you success, and that some heterogeneity taking is, for before Glove question, do the to helped that into in for jump and for really how Bucket the pros will of measures success, thank And I'll further Sorry back long the of

Sujal Shah

Thank the Yes. questions. you for

of me course start-off add to and Chuck well. Let I'll ask as

to with has associated and was a patients a disease disease that's question associated progression free with particularly liver of with and of first been alkaline Your been of improving normalization transplant around respect treating phosphatase, survival. and which to reduction enzyme biochemistries progression particularly the reducing

In normalization of and providers in where terms anywhere date, to from field the enrolled there's treatment of our had many the conversations agents prior clinical I healthcare seladelpar of as XX% X XX% of years of thought we've years actually leaders experienced as like X alkaline question the no that patients between studies to in phosphatase. globally, discussions, our our in seen studies potential particularly yes, with and we've think

a data would able treatment There's no bring biochemistry. It's question proportion to to not the [ph] historical a think have about on that absence really really the do fact normalization. been actually alternatives to know levels only you respect into PBC of phosphatase good them patients tell not but sets something to to The bring push you been as treating transplant potential you when with that now well, of I to databases, in point but of among in focus free normal there's increased patients [HCPs] survival benefit group, that an alkaline have gathered many lower, the others range. bring global study when normal you that

we I from at which appreciation potential over the is community there's payers appreciation greater and time, think seladelpar the association healthcare think in of a think large. providers. we has. much is So, from that this And And one one greater this advantages

add? to Chuck, anything

Chuck McWherter

No, I pretty a summary, that's Sujal. think good

Sujal Shah

So, M&A. I pros of – the around the question the yes, second part think cons and it, your then other of part was around

of me functional bring experience let drug be We're CymaBay and First, talents building the to patients this all clear. have to really to ourselves.

are disease path relationships resources, really better what is execute believe in with we seladelpar can allow of committed talked We of bring to not the creating but we the this path even to forward able we investors upon the some the prepared the forward, We're in as to in firmly internal about beyond ourselves seladelpar that patients certainly may objective PBC remarks. the committed think have greatest on accomplish understanding this to just as balance effects know the key today. And providers, we and healthcare many to as to being we benefit we sheet and that to something this value. path as believe us significant

potential to it interest, or That's responsibility how of we think not recognizing company. of calculus. that When absolutely do operating obviously, either about the our fiduciary always we ignore the pertains are partnership strategic M&A a benefits part have we

partnership, least at will say terms I In this. of

additional is in an will Japan to forward. firmly accelerate in partnership area Japan. bring is patients activities PBC one in there's in which potentially to now believed Kaken required the seladelpar we which The path it clinical with This

ability today, and well the overall the register that on Europe as have have that to we response our with in potentially seladelpar we think today, in program have study we the the the we own. balance U.S. and sheet With

get this near think can objectives the here evaluate we'll the on partnerships, that alternatives closely very data. over we outside present us where particularly we'll thereafter. may And And time, to we're to continue term position U.S. we execute as those in themselves but about to

Chuck McWherter

visits or the to it's And for members we impact question, held, made. Asia the but We to even relationship. we get North saw enrollment, to terms of Yas, sent meetings. East, team the the that Yes. we outcome about The across investigator your in Europe, that of outreach Middle also site America, the that, benefit to the Yas, about just

terms what probability qualitative experience this think – real really, It's in And is I get think I to high the feedback may think able increasing It's sense we're quality of you this, physicians we what time clinical going to be the at have. a of getting data. in translate do into? that

cleaning there's being locking if need be there's things We directly to them them if to us, database, in findings discussed, drag have responsive, that having importantly, to out. the and efficient to Not the be ability having relationship and responding the letting process. reach-out being

with mind different that's in really think the from in my having implications study. many I so sites contacts clinical our

I think for important. a really rare disease, this is

Yasmeen Rahimi

Thank you great much color. all so the for

Operator

your Steven question next the James. comes with proceed question. Raymond of And from the with line Seedhouse Please

Steven Seedhouse

pruritus of where really some for the of drug, addition on Thanks Difficulty] to course question. the Great. secondary taking you could from [ph] market competitors seems potentially. It us endpoint, there is including other differentiate that [Technical in to seladelpar the effects primary

questions So, into I I them. drill down sort those had a about of just couple and wanted of to,

quality the the disturbance. sleep first So, and measures like is of just fatigue on life

Do have on you you'll ALT and any And on in quantitatively those? improvement system, PBC-XX question endpoints? function secondary these show same the then scoring expectations demonstrating for is basically measuring look So, liver as AST, RESPONSE? you test this are to something for benefit

Sujal Shah

you questions, you Chuck, Thank commentary? to want give Steve. the for some Maybe Yes.

Chuck McWherter

Yes.

good observation, a Appreciate it's very I Steve. So, that. think

RESPONSE, we show may know Liver disturbance open may study, International in enhanced in fatigue, that to But well well. question. in an that you As and then diary. your paper those as as measures you which the you And that as the as and domain, using – electronic answer an diary driven on PBC-XX assessment was label the in study was Liver that's did sleep know International the was improvements in from those also sleep paper, from [indiscernible] we’re our which – we're measures measuring now paper, as well our as a in

So, frequent that at data we'll intervals. collect

see what we They're to they'll they I And pattern. something the seladelpar I are if that be to impact powered, and wait be do just expect consistent to not see. but statistically see a see to we’ll We'll secondary have can interested think that endpoints. very

Sujal Shah

only with understand overall, as respect from study. PBC The focused other continuing thing very even RESPONSE, the patients Steve even the Phase beyond to is, add in to program we these a in that we're broad top X I'd line perspective data to effects in approach

course enzymes, this liver particular, potential So, and how PBC-XX looking on measuring pruritus, on seladelpar is. including the effect think even in of mechanism of anti-inflammatory of the understanding for ALT fatigue disturbance and at support collecting and sleep effects a seladelpar I

are be which treatments to just you. dig invest from we in other but as These to for are differentiating development potentially patients all significant very with in because currently and PBC, not treatments well. continue that existing agree features, we do areas may These from with continue resources

And so, continue us see these in particular. in to going to areas invest you're

done for done additional we've publish to as developing started we first historically. seladelpar we XXXX this And as would eventually with anything work, patients and have really meetings since learned through PBC, that we we when at medical look share

Steven Seedhouse

pack to to important ask endpoint just pruritus be and that is there. about you how may obviously the yourself as from I well, separate the great. That's able want given guys

the of you the proportion for to you the So, NRS first, on baseline just criteria? expect if specifically greater study share can equal how patients I'm based X than qualify in – on to or it's curious like analysis the

curious, X, measurement then day the point. to around if month grace every to where curious of weekly the measuring? Thanks. a X-month I'm a logistically X month get outcome or I measured that is And be period then, And is this believe some let of from how X trying or average at weekly terms know of that's that the steady just is this average is sort month at and time to you handicap Just in analysis? here to X there start state patients works,

Chuck McWherter

Yes. Thanks the for question.

enter As we’ve intervals now, in the life The know, Steve, you of quite patients diary a daily. quality other experience NRS this. measuring bit have their of at certain and measures has electronic

And I the can ENHANZE the continue collected the the as So, compliance every taken that answer very period. over and an X in the months, throughout they that's daily defined is high. was say day. least is the at study, to run-in baseline first average Then NRS

recall entering like the about XX day. And last hours good the very was what in period are past their itch their data. is, patients So, the in

daily And X and instrument, last we the that of ENHANZE of used average same is that So, course, analysis X was all at X data kind other the point the will collected the the along that time of confirms is and is device. the month days. which then they gives a in methodology results supportive, collected this months the have the highly way, through really the end. And the the we same validity of electronic confirm that study same – sensitivity the

Sujal Shah

we’ve secondary this greater seen of NRS of or is This patients age north XXX and endpoint. XXX ENHANZE X And thing study the to that Steve pre-specified only to measure – an XX% in patients approximately randomized in about patients other X baseline. our at population then to have severe moderate X historically is, add about of label there the open our in Phase study,

expect a as similar in this to We well. study proportion see

Steven Seedhouse

so Appreciate Awesome. much, Thanks guys. it.

Sujal Shah

you. Thank

Operator

the line Please Kristen Fitzgerald. with Cantor question. comes of next the question Kluska proceed with from And your

Kristen Kluska

Thanks Hi, good questions. taking my afternoon. for

So, normal debates earlier of But eye XX-year Q&A. touched starting was So, meeting is other the anniversary second conference first, this its the the or on on in that before? listed which the that just one on therapy the having you're line a listed X one global close now at of the then study to your very group debates caught program focused you in whether or therapy having is was thoughts next our successful? data PBC ALP, event I now? that And might And might month. months saw you're you getting closer what another be anything should given are to else physicians be, if especially be this conducted wondering on that at I around

Chuck McWherter

will question. Yes. yes, Thank Kristen, meeting. very Many us excited. you in we're be all to It's for going a the be of great attendance.

UDCA a others. patients I should there somewhat one-year of thinking some than you think patients, it year that when maybe point for time of be and the terms little some was where longer takes arbitrary this bit for has been treated, In try well a historically at

the PBC challenged no has in around at global have is diagnosis, this. wait, that reason is a a to wait limit particular, of been Increasingly, know level I for normal, that's and research study of been Xx even if lot that right not And full-year. that you at examined that there least work-out there's upper group there's said at a

And manuscript a was so, prepared. was there I that know that

drug benefit of that should been if line the especially be know it's but published the therapies taken versus consideration. for don't for yet, really some a the risk, it like, shows second into I

The second question? your part of

Kristen Kluska

keenly conference that else there Is on? anything event you're or at the focused

Chuck McWherter

Yes.

think see – who from thought committees. guideline So, a to sit discussion these the going of on many lot you're I of leaders which are

risk So, hear influence So, to to alkaline a lot expect when and normalization as a should different treatment measured? started? say already how I is And about risk consideration. is phosphatase key you’ve going guidelines that be mentioned is what considerations we think

and discussed. means but other range, are Higher in being the it. quite levels of at normal There the strata risk that increasingly that bilirubin which are often risk higher are bilirubin, end

[X.Xx normal carrying same levels, between below limit greater a [ph] as normal, the into low their alkaline where upper X.Xx with or put upper seems is so situation subjects. So, be for normal to that at patients along limit they phosphatase progression that Xx] is healthy recognized risk can it be can risk as and

normal you're There and where looking desire normal score recommending to think these at be that I the really strong leaders I guidelines. and was And opportunity the therapeutics treatment going with see going. from a phosphatase meet alkaline globe is excitement adjust paper understand all to to us, field a the the think for the levels, is group just levels the pharmacology alimentary goal. in and should

paper this. So, this supporting been that's second the that’s published is important

Sujal Shah

other only evidence. real around at think data of year, in world the discussion of meeting but XX-year is, the The our global, and thing lot increasingly panels for course this anniversary of interactions I'd add, throughout just Kristen at this a and world I advisory not the generating real

impacts of this so, to and seladelpar for in symptom addition specific And burden, another patients. about on life, is disease thinking burden quality area

real about the world potentially world also real and if registration generate towards as we're data the have We're commercialization evidence and we committed to program. thinking progresses successful to seladelpar in opportunities

expect to this have others. are So, I and discussion around meeting these at also topics continued that think we

Kristen Kluska

you terms on in Thank X, drugs? now over with passed in and the you having And of that the milestone an for of Thank update X of you excuse XXX have that. patients number metric, patients X do in years have again. ASSURE, me,

Sujal Shah

this. say I'll

it first set had previously that back seladelpar. up, brought as ASSURE know You was patients on been

north then study. prior at the had that earlier for on think I XX X from on been been studies, years from points even were a least our which treatment and time of that that drug of potentially our XXX patients for had clinical year eligible at various prior least ENHANZE

So, bit it's stopped for those of then some and patients the discontinuous restarted program. as a had we

periods as And combine think we a and so as those there's mentioned, for of a two year time years, number had the different started particularly ASSURE, by of experience even with certainly you I Chuck over good patients two patients.

rolling now over course of from patients We have RESPONSE.

of approved and believe was even in obeticholic that response. be patients it expect and point provided will So, we've to specifically acid, the effectively in as when and there as that of would file simply at many treatment, two-years as we were only greater well the than There even numbers we are to to register other going patients that exposures successful think not you time be second-line to numbers. beyond today, patient totality, number even one-year seladelpar, are when will of acid one-year the those look have to treatment would about of but obeticholic those I registered. tell the of well, time numbers the we that

Kristen Kluska

again. Great. Thank you

Sujal Shah

Thank you.

Operator

LifeSci line from Patrick your question next of the proceed with with Capital. Dolezal question. And the Please comes

Unidentified Analyst

is [ph] This for on Patrick. [Sebastian]

Just a couple from us.

relates seladelpar pretty has to positive signal. a pruritus, it shown clear As

curious of on modulate and any pruritus in to Just have evolving PBC if seladelpar’s thoughts [indiscernible]. you specific the etiology ability

seen at autotaxin, IL-XX, bile have data and others? or on but we've acids, Specifically, CX looked you

Chuck McWherter

you a Yes. question. that It's question. great Thank for

the a have lot of mechanism understanding interest terms of by effects. the We

a in mentioned, specific who pruritus bile intensity see pruritus. had There As baseline correlations a also acids. reductions we those you've patients with acids, did in between as well bile reduction as was and correlation

the is disease view with of that bile on levels the both connected Our at and impact those. acid inflammation inflammatory moment is cholestatic

might – The what [indiscernible] have understand very currently coming identified, been in be and the effects, seladelpar where but anti-pruritic the se we're the what not might effects [indiscernible] treatment per active from. specifically trying to are as

Unidentified Analyst

follow-up. one And just Great.

fulfill real you through looks so potential full-approval the the going Thanks any like it post-marketing and to data competitive us Ocaliva? to implications post-marketing So, is side, for just Could to submitting of on its be study a much. Intercept FDA requirements. world walk

Sujal Shah

appreciate the Yes. question. I

statements. our is So, on their expectation same the just public based

early. course, committed that didn't X terminated outcome their benefit. Of Phase we study show know cobalt was It

what regulators generated obviously looking us some It's hard speculate evidence. at has data will to Intercept really determine. However, real the world for

endpoints to as tied with the PBC. outcomes of know – phosphatase, if is approval, at namely to one is and there being somewhat cholestasis, for your biomarker to specific you would if themselves, basis think thing, think normalization the around full regulators from bilirubin say, and being assessment an I question, improvements of for support I a alkaline that, the validated of I patients

on to but fundamentally the response. surrogate we're that to using things that endpoint improvements that the seladelpar, we based what then continue continue your tied it are These a support for supports question, obviously outcomes. be what explore potential might of in think in we would to so, And the to think for seladelpar was approval, as we also of see I be if we essence I commit reason strong with see to, to full a there have think some I

Chuck McWherter

still The there's happen, no think significant only really that, a it the what there's not were in to be, to it's need this thing I unmet likelihood add that I that of would clear but if doubt would population.

First levels acid, lower about to but those phosphatase, the half get don't of of patients time. on of all, alkaline obeticholic

patients have getting And of and would a that believe so, benefit to wouldn't subpopulation. that be part you outcome

those least They're cirrhosis, Obviously, at in using and with hypertension. of compensated evidence safety issues itch. And to visibility of it in currently respect patients the with there's label. the of with contraindicated there's the portal question the then a

we So, that potential a who there those would need solution to be and think needs. for needs be significant would still be that addressed have seladelpar patients

Operator

Arce of And Ed the Wainwright. the next your proceed H.C. from with with Please question line question. comes

Ed Arce

Great. Thanks for questions deal Kaken. with the my recent on for taking me. Three congrats and

over market Wondering Lewis. for probably to and commentary comments relief? about Ocaliva. provide obviously particular research you've go discussion your that profile market particular, there wondering in I'm around all you I if made in more First, pre-launch they symptomatic a prefer some in recently infrastructure seladelpar's done your can patients show the appreciate plan. some you

is competitive soon. obviously, X Phase data expected with secondly, then PPAR compound And

allow Given lastly, [indiscernible] your the data, especially key compound? you view on clinical prepared data, reviewed is versus to so here, be the I example, patient question how the – desire do this my secondary And how are of us much. in positive? unencumbered factors PPAR that if for of key endpoints then balance through quite you shown remarks, to clinical totality strongly still overall Thanks in early, differentiation, the capture recent access the the terms is, of full you would thoughts all broad how pricing, terms your that but with acknowledge the of in talk profile of the value, just need to for

Sujal Shah

and on continue the if early Appreciate you the potentially work as And we'll are maybe we the and with we to have seladelpar question perspective response register. look we've to I'll today research a profile work. work we the of first may market Lewis that product It's on through readout add respect if that will, successful of have target of believe confirmation, continues that some from done, can the questions, and Ed. here start-off very

at look obeticholic acid. versus we seladelpar When specifically

here point you me it's First, but to doesn't I described to I important from from that out cross think data, come comparisons. for head-to-head study anything

believe beyond. to normal and what for ability of the is the bilirubin X to populations we looking months caveat, with alkaline upper X.XXx we're at patient similar a months what are far So, limit seen proportion as or to whether below that greater normal bring important patients goal we've seladelpar or pertains XX of phosphatase thus it in

favorable of we've you then a some actually experiencing very greater about We from ursodeoxycholic which to That's think also with treatment are already. on that And that pruritus proportion itch. as see potentially to differentiator of patients symptom significant a a therefore shown effects has but quality acid, with for talked we mentioned, patients. just actually reducing obeticholic effects even first-line respect be, could never life quite reduce bit not normalization, burden potential improving acid, generally which from and been

safety. And then about finally, overall thinking just

to evaluate differentiator. as potential disease, safety. that of do have to but non-cirrhotic and patients continue for the development well beyond, program we good is also as Now, It's patients, compensated to our necessary us safety to through continue across a potential population cirrhotic

agent and is this of put so, for of we've preference the highlighted seladelpar market have that gaining successful development registration. potential that really like through of we And an research the if this some think overall again profile payers some done when we're in about front even HCPs,

there's differentiation seladelpar areas we of efficacy, as well positions think think as I number a quite well. that potentially of tolerability, safety So,

Lewis Stuart

to it's but to comments preference able to I know see a more really I respect But their you think the I would value access And gaining see really really and think supportive and we importantly, going Sujal’s got think really really be product done the very payers proposition. of be good insights co-pays importantly, par more at process around patient is I we that to I more obeticholic would are to, they to current acid. medicine. that, how the this least certainly much for them be pricing at think and pricing clear obeticholic being seladelpar the target think to the only market with I we've add very, the describe some see thing research the with to of acid, profile to would see they response really

see And as seladelpar's less have medicine. headwinds a we'll commercial profile, product more both with in that head the access patients gain and eligible into provides to XXXX really importantly, on to XXXX, the great Medicare the I to opportunity certainly we for combining side think what

Sujal Shah

relative study for of A Ed, to currently. Elafibranor, I think around as then, a with And in which things couple here. X you well Phase asked also differentiation, PBC, question is a to highlight patients

our screened we've would our robust, be as register XXX exposures. over look program the thousand in a unique would north As about to patients being already we quite our talked to time have studies, patient expectation seladelpar of by potentially clinical

quite confident the of we're date. in profile So, seladelpar to

that of the response described. the PPAR to date, to a that things is based mixed seen I've a already look Elafibranor to patients all proportion alpha confirm we've profile We significant study of really in on for in trial. XX that that dose at milligram Phase X Phase treatment. in they're XX Phase enrolled delta X their studying patients to XX-weeks X patients the a XX out PBC,

data set So, for we've date. a generated to very relatively what versus seladelpar limited

but seen for What there's differentiate its its we least potentially set a that anti-pruritic is seladelpar safety. effects, anti-inflammatory certainly phosphatase at to differentiate lowering, we've on effects, as on potential comparable think potentially data even as in well alkaline

I the very think those small things of study sort based conclusion date. to hard three to Elafibranor with conducted generate Phase any, on a X

that mixed PPAR order versus X look to better as make alpha may seladelpar PPAR have very certainly of the in agonist, advantages a delta those. that significant we of delta selective Genfit's mechanism Phase to study We'll potent comparison to believe well is carry elafibranor. a situated a uniquely their But

Ed Arce

That's Great. Thank helpful. very you much. so

Operator

Oppenheimer. line of question. your Olson question with proceed next from Please the the And Jay comes with

Jay Olson

describe you then Japan the terms and other also on opportunity Kaken lastly, plans Hi, if have in you Kaken. Japan? please the any you then thanks Congrats the question. market used reimbursement Thank for partnerships dynamics? talk taking please you. to seladelpar of do And patient besides Can And identify an about search ex-U.S. in partner? to criteria deal as with ideal the could you pursue numbers for the

Sujal Shah

it Thanks about for Japan end thinking in to patient then And other the question your opportunity and questions it back first going Lewis geographic turn there. how talk Jay. with the come to about opportunities. specifically we're and potential then I'll to of I'm numbers licensing part second start and with

in First search terms criteria, number looking all, things. of a we're of of our for

patient experience with obviously partner a of having care the focused this on advancing in specific a characteristics for being and geographies, in in to enthusiasm for life heels our of the First patients care quality for of on that all, talking all case Japan, really Again, of, we've seladelpar today, been about in of accelerate potential the partner PBC. specific really commercializing in shares around and patients. history

these think is shares there a alternatives, a found seladelpar. a represents. in that opportunity. we enthusiasm Japan, partner the things I better some do I mentioned, opportunity Kaken Kaken have for country are couldn't in of that core as line this again which we there for second our here And believes clearly that are we as And believe no significant treatment

Obviously right important So, in of experience may think right with patient we us. the And aligned a is making seladelpar. as the partner are the like differentiation that of potential partner then to benefits other we one. patients enthusiasm the with critically have things that's about and offer course, geographies well. sure right The economic seladelpar how access

then put allow to is to tie some things the redistribute those part of globally into and this In non-dilutive can case, economics important we to that how key of consideration. continue It's us capital forth other program the that capital. quite the the

a box would checked I areas. have of number number diligence, of excited So, a some we conducted of are you parties parties to tell the that that these on

looked it end, really the And we've in Kaken that to best-in-class areas pertains for. was of the the as all

in this that, In market the particular, in invest. is overall is terms I Japan, an think area to continuing opportunity of Kaken

as work Japan. establish think to to continue that opportunity to market And for in appropriate itself them they very some how really may to think do I our here. continue partner I will be present able

speak again, specifically I Certainly, And more the ex-U.S. can strategies. prevalence Lewis back come perhaps. about and other think numbers then I'll just to talk overall

Lewis Stuart

Sujal. Thanks,

XX,XXX Japan. there about in So PBC patients to are XX,XXX

the for actually medicine. get of an One to about have is, drug better And have as designated much patients, at Japan the they unique access the a of PBC it's to very really irrespective creates and have income allowing to full ability disease. patients approach opportunity that things throated the an for co-pays intractable

just anticipate to doing would on opportunity, patients I be would [indiscernible] know deal great be done but of that be some work there work. a needs somewhere still is between of And this. to Kaken going that second-line We

Sujal Shah

to bring it's then asked how other U.S. about to globally. And finally, And bring we objective patients I about to always think seladelpar been the our seladelpar We're committed geographies. to patients Jay, in know you obviously

the we continue RESPONSE And outside to today, urgency. allow explore resources that to think the We balance we're really in inside will company, I'd not U.S. an sheet, and the simply Europe. U.S. a the in you believe is the us given both tell those given opportunities study in register I

We dialogue, but of about we'll continue data, partners. about we the think on get as those other other to economics level and of side the partner to think with things and most potential right global really the opportunity seladelpar have likely for right maximize

Jay Olson

Okay, that. to great. forward Thank you. Look

Sujal Shah

you. Thank

Operator

proceed next of with with the question And Julian line from question. Harrison Please your comes the BTIG.

Julian Harrison

taking Hi. late. minutes questions. I And apologies, a my you Thank got few on for

second-line discussed. a as significant to you try is become a possibly options patients be But others factor how could this treatment PBC available? to on motivating pruritus not So, hopefully, I'm for comment specifically wondering already if you expect when other

space development anything [front I'm wouldn’t seladelpar primary then the is there's in been in that and pursuing [ph] of [ph] And for Thanks. indication? [sclerosis if but have] formally before more clearly [ph] curious cholangitis] PBC center] additional now, that [you

Sujal Shah

questions, think We Thanks the pruritus Julian. is important. critically for

for potentially reflective of XX% the amount patients. reflective clinical experience of the a in life broader had quite XX% studies, and least will it's we in many which patients to literature trials front population, groups in of again a at on of moderate severe all, our as we've work done significant their significant course have quality and of the of a is our First quite suggests spending patient of itch. disease patients of in time direct of amount pruritus think with The impact advocacy as

different of goes itch affecting away than affecting patients the be that work, Cholestatic their to it public. with never scratching. to ability dermatologic itch itch It's is even as in their ability type really quite describe

for to elements having simply this some very itch are on life broader there beyond So, a but significant patients. overall quality being impact plaguing, of

intention critical markers potential itch disease, again ties clearly progression. is of disease, drug markers to ability have a stay And and potentially so, treatment for we cholestatic having disease is like to to with key the also It factor. of seladelpar to we elements to compliance. reduce The reduce on patients think the are potential the significant inflammatory think related that

better reduce pruritus, long-term you potentially on overall drug when compliance that could have significant a that it suggests can potentially can a also liver And health have patients. impact for

things are potential key going these is we together differentiator the seladelpar. pruritus at tied and element be So, to a think it, all fundamental of for

Chuck McWherter

only hinges on diseases that the and add other thing Yes, in I the activation ways in successful many rare would of really is patients. marketing

symptom. a to And patients an studies in in with our label, that ends up be be the and treatment be so confirmed ability to the ability get them if available this that the to to able, opportunity activated, to communicate deal to aware directly have there to finally, could

important of our part to be I think strategy. marketing it's going

Sujal Shah

towards I see in about for a potential actions a significant other the seladelpar PSC. and reducing inflammation, we've NASH indication PSC. well. could think second certainly saw think on in and Based the we to be pruritus have just areas on that with seladelpar bit of about on specifically bit of terms we we've there part a effects these you its past for as well on an geared very development fibrosis quite thought effects addition talked of which talked in cholestasis known about opportunity mechanism patients, the Julian, That's we your mechanism a then, was question, And and therapeutic in what mentioned

with And some today PBC. term on near we PSC, more to in as be very and very create have think a and we're but to as in discussions clearly internally to study if at focused objective we're term pertains it endpoints focused. progress we near detail point continuing continue we'll value leaders, thought to there forward to design, Today, I share have

Julian Harrison

Okay, great. Thanks.

Operator

with Smith next with comes Thomas line question. Securities. the proceed of from the Please question your SVB And

Unidentified Analyst

is for on Mike Thanks for Hi, questions. everyone. This our taking Tom.

provide back you about talk can standpoint what think to order On you from steps seladelpar will clinical how of it] to in separately, that data Kaken be development plan happen? market of And as on deal, secondary XQ? of numerical [to some the the a get you needed the there? do write values specifically the then could initial And in [ph] for Thanks. endpoints and part quickly to

Chuck McWherter

Well, thanks Kaken, process respect is We for start. We're sub tech The to formed ongoing. teams. a off good transfer those execution to we're collaborating. questions. With very

Japan, And terms then we efficacy establish In Kaken's of known study course, say, using a in clinical I in responsibility. typically, what study X because global overall patients. subjects. typically bridge Japanese exposure you'll is development plan, Japanese will the the it's to that an have it's in Phase to of

bit [we’re] are engaged a terms as really the currently of execution good the as to early little Things us, really as off it's I've timing, mentioned, sub for joint these well steering with In a teams. start. just [ph], I encouraged. committee, think But we're

steps. We're We They're information, have through They're strong of with next specific the [ph]. lots to potential onto them questions. the comb] fine asking team enable large really very they're going a this. They've put data about [tooth relationships. with asking able really

set all pharmaceutical drug together consideration. disease to the our of of advantage of us very with their and really and leaves take of knowledge to development and regulatory the that we that the work just a knowledge partner circumstances landscape, a It wants the found the Japanese encouraging

So, I think it's going well.

we'll perhaps forward, clarity in move the greater position not those we timelines, on but share right now. get we're a As to

Sujal Shah

second expectations. the know I then data was question top And line around

expectation effect share at key share is two safety to intention of well two the in have itch phosphatase severe top will summary endpoint But line certainly itch the at that as primary well. key readout, the normalization, both as patients the in is it baseline, the more overall study. on an Our alkaline with our obviously and point to data as the that endpoints secondary endpoints moderate to secondary

Unidentified Analyst

very Got Thanks much. it.

Operator

Please Riley. from Mayank is question the with line next our B. And Mamtani question. with of your proceed

Unidentified Analyst

couple Mayank. Hey, for team. taking [indiscernible], Thanks them. a is This of asking for questions

how little your thinking on think us see knowing of you design peers? full I [indiscernible] from approval your about perspective study but more give of one we your but both and start-off, might touched thoughts to could a this you're is a timeline by a bit Just around briefly, outcome that

Chuck McWherter

Yes. question. Happy to that take

know for an likely post might H based you have outcomes. engaged of accelerated We've reasonably and that commitment quite use. Of predict some been the we outcome various study even approval in approval to time back enhanced days the course, as through seeking we're a surrogate we are pathway document that to upon thinking approval in Subpart approaches

alignment to adjusted outcome We've their study generally of clinical that We've document gained study. the yet quite shared had We've ready we'll not of We've with terms interactions to got conducting FDA. feedback. We've We're in documents. on need extensive a what set to share but how for from learning expect all number us it's would considerations, we’ll – be we of you'll going as patients, to duration, look a like, yet we study think number we take. around get long the be going of close what specifics it's that. design,

Unidentified Analyst

if how thinking requirements? then you're things And for get talk about, you're to the things readout. CMO closer Okay, the we great. you. as maybe Thank I And planned guess, thinking about could Sujal, as you side from just the session like post-marketing of

Sujal Shah

last in internal Yes, of point has I year, as leadership role the Scientific things have facto question. any function. we believe de research internally, few Chief into ever we it's team in respect XXXX. it expanded and clinical since end clinical expert executive With to the President Chuck, development really PBC of from our to a been we out. launched pertains Officer our in our our both Look, great to think Obviously, important don't a gaps to

been his so, for inside a company. obviously cornerstone and us HCPs have think with really globe I and knowledge the across a And us, the PBC and relationship depth of for foundation

a on risk the the as heels any we as as potential potential third built team We've look have believe would in get biometrics. operations, don't them success seladelpar to of development, we of development A line individuals affairs, just team program operations, have really top the in clinical register that and medical we execution data execute well. great quarter clinical tell you, leads – in assembled, to in to also below and I even

risk. team in is an to So, the and exists broadly, very They that functions. I fundamentally, over gaps. Obviously, the to up just we important for think team here find time, complements don't to individual but now tremendous function down us We've a see including don't I'll CMO today. any have continue any team that you, across got tell develop the organization our the goal

as about potentially next serve think this transformation the us company of we can iteration really commercial. And the from stage development in to

Unidentified Analyst

to forward data the That's helpful. quarter. in and questions our third Thanks for Excellent. taking the looking really

Sujal Shah

Absolutely. Thank you.

Operator

to no the time closing this I'd at any Shah turn comments. back floor further for are like There questions to and over Sujal

Sujal Shah

you for thank once us today. all again Well, joining

an providers, and we It's and the readout activities to seladelpar third top year ahead approach and of patient key others in will to continue at play look that be As healthcare accelerate. along to you. quarter, we RESPONSE data all with exciting line you advocates, with busy patients, meetings way. and forward the presence going will and in sharing updates to our medical getting role Thank these many a

Operator

today's conference. concludes This

a at and your your this great lines time. disconnect may Thank have for day. you participation You

Cymabay Therapeutics (CBAY) 16 Mar 232022 Q4 Earnings call transcript