Cymabay Therapeutics (CBAY) 12 Mar 202019 Q4 Earnings call transcript

Company Profile

Participants

Dan Menold	Vice President, Finance
Sujal Shah	President and Chief Executive Officer
Charles McWherter	Senior Vice President and Chief Scientific Officer
Yasmeen Rahimi	ROTH Capital Partners
Eliana Merle	Cantor Fitzgerald
Steve Seedhouse	Raymond James
Jay Olson	Oppenheimer & Co Inc.
Ed Arce	H.C. Wainwright & Co.
Ben Porter	Stifel Nicolaus
Joel Beatty	Citigroup

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to CymaBay's Fourth Quarter and Full-Year 2019 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode.

Following the formal remarks, we will open the call to 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.

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

Dan Menold

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

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

Scientific Joining and Dr. Officer, me Chief Officer. Shah, Executive on the Sujal call McWherter, today Chief are Chuck

milestones, assessment will call our upcoming We an clinical position financial a update for the strategic of review of before provide on open and pathways programs, we Q&A.

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

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

no assumes statements, as future update result or obligation supplement whether by information, except any events of forward-looking new as otherwise, to a or required company law. The applicable

set statements. factors for to in the directed CymaBay's SEC, anticipated quarterly in cause forth in Participants reports well the today's with materially risk could statements the differ are set factors as those actual forth and cautionary to press forward-looking the from release, as that filed results annual

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

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

Sujal Shah

two in and announced to in by joining histologic potential initiatives of study seladelpar seladelpar afternoon. the parallel IIb findings unexpected the us. development an for on alternatives identified – NASH have we Since you of of Good been investigation an strategic Phase the for the focused study thank of decision we last November, the halt evaluation And pathologist company.

these with development. let November's the decision leading Before events I halt seladelpar up briefly review activities, me progress through step to our to

double-blind, In IIb biopsy seladelpar, placebo-controlled, dose-ranging XXXX, with which a confirmed initiated XXX enrolled of NASH. patients we study randomized, Phase

was efficacy at liver and evaluation the of in and comparing liver fat at secondary outcome improvement and assessed baseline from content measures XX primary key XX fibrosis, by change baseline histological weeks in taken NASH biopsies The weeks. as included

AST, fat, meaningful June In of liver liver but reported phosphatase in GT XX weeks. at gamma clinically ALT, alkaline reductions reductions XXXX, we and inflammation markers minimal in and including injury, robust and

patients their by in conclude and treatment the sometime the assessment in completed for year. the their patients review XX As study majority finishing of plan weeks for XX of weeks the blinded pathologist the November, February them began XX week liver treatment the remaining biopsy who study those been of this were had to biopsies, had last of of

histological pathology. the batch of NASH read subset with slides, a identified overlaid an they they As on unexpected of pattern of first findings patients

markers characterized as predominantly as pathologist These by interface these without duct Despite were identified us bile an GT, including in CRP. NASH study, enrolled injury. sensitivity treatment, which of they unexpected the alkaline of findings, ALT, patients to of weeks with unexpected described bilirubin, had and throughout high or and hepatitis the as which findings, levels those pathology, or observations, liver gamma direct having improving bilirubin, histologic phosphatase, stable injury XX total either biochemical and the included inflammation AST,

be there progressing or as markers allergic reflected signals immune of associated of no parameters. platelets that such in other injury, liver by liver with the addition, symptoms changes or there can were reaction in or in were coagulation eosinophils In as clinical nor disease, changes

AEs were liver of or occurrences these related patients. liver for of No decompensation observed any

prior our on based unanticipated with were pre-clinical clinical findings experience and these seladelpar. Importantly,

After to of forefront made in-depth seladelpar the decision development of pathologists with mind, in was of our liver these and consulting findings. the at an committing hepatologists halt review to safety and patient all with expert indications, while

with our FDA a clinical and the subsequently agreed placing seladelpar this further while on decision, to provided input plans hold development situation. formally The investigate on

investigation the intended study to three confirm identified Or by pathologists. includes of and activities findings the understand subsequently significance our

injury. of collection demographics, broad markers is elevated history, of first drug-induced biochemical data, set medications concomitant a The comprehensive and in and patient medical a review liver typically including

of second of and liver by world review end several both a The baseline renowned is blinded, treatment pathologists. independent biopsies

are the consensus hepatology we determination which finally, And all review of clinical of will looking of provide in in the experts second pathology and meeting convene to independent the review role during findings. formal the these information panel middle seladelpar third that an to gathered a is quarter,

will follow-up findings the be with steps essential us to to the the and requisite dialogue These nature FDA. of have for understand and significance the

the end future of potential discuss After to seladelpar. quarter the second with completing we meet our plans investigation, the before try plan FDA to to for

Let to updates. with provide Chuck? me Chuck ask some you further

Charles McWherter

Thank you, Sujal.

liver review XX last for our November been decisions biopsies the has review a on Our study completed were all patients XXX pathologist. by end-of-treatment end-of-treatment read Since of biopsies. with based first then, the

associated were or drug-induced including allergic either Across reactions, stable. subjects autoimmune histological with or the improved of findings, standard unexpected liver these laboratory usually and all with without markers injury,

alkaline unexpected AST, encompasses whether including of Again, phosphatase This gamma GT, independent liver findings. bilirubin. total all there and ALT, not or tests, were

liver-related of patients Further events. any medical pattern unexpected or symptoms, display findings adverse findings with clinical not did

corresponding from XX.X% groups respectively. were were and XX X.X, in XX.X, patients The XX.X, minus week percent XX, ALT respectively. and there minus and the XX at liver in evaluable at plus XX XX milligrams minus placebo; XX, baseline tests XX, weeks, reductions The XX XX seladelpar

minus minus seladelpar. XX, AST, reductions at relative minus minus XX, milligrams XX.X% week were XX and X.X, for XX Similarly, XX.X, placebo, and XX for

decreases minus corresponding minus groups gamma XX.X X.X, GT Finally, for in these respectively, minus minus XX% and XX, were

bilirubin resemble phosphatase the The total the I results parameters and as effects XX week at week at XX well an we as reported in last June. mentioned, alkaline

we analyze changes today, any And study to the also have biomarkers. histology additional our see to by treatment yet have identified on might explain that pathologist. We begun

histological having stage us The worsening are either, the group responders to two in fibrosis endpoints, by or NASH Phase of resolution that or the in each share as one, endpoints III of defined allows treatment zero of namely NASH. those endpoints a secondary two, lobular of fibrosis score study. used a key no now one of ballooning no completion score stage; one the proportion worshiping the have improvement inflammation by important more with and most been with zero or the end-of-treatment The in of review

in XX the seladelpar with entry and XX, in the and seladelpar XX, XX, four treatment. end XXX subjects biopsies you paired Out into XX milligrams of groups treatment I'll XXX were X there to of XX, XX patients X X at XX X of enrolled respectively. biopsies The remind that of placebo randomized to were study, groups number and XX ratio. patients milligrams with and XX to the placebo, in paired and study

were XX%, and XX endpoints XX, meeting in improvement in responders respectively. for patients stage at XX.X%, NASH X%, seladelpar XX.X% both were XX.X% or in The the XX.X% with with in X, groups were milligrams fibrosis and rates of least groups. worsening percentages XX, milligrams corresponding no XX resolution X.X%, XX.X% more The of fibrosis no NASH the seladelpar a and for XX.X, XX XX The one worsening XX%. and percent with placebo, XX placebo, and

We features pathology of The of accepted our our an biomarker scoring include blinded in a believe will in study. the as at reviews this population Ishak and scoring review population, analysis completion parallel detailed end-of-treatment. present pathology histology provide ongoing of the in HAI Modified of independent quantitatively with framework, biopsies to and patient characterize both known the baseline system, patient additional the will independent liver picture

entire features patient and central for for hepatitis, the we in baseline at clinical believe and development. allow review to expert existing panel second scoring seladelpar to regarding not of dialogue quarter, with which the severity NASH Among end-of-treatment will informed for look quantified properly the pathology. will outcome includes we in scoring picture these our convening be of forward and framework FDA presence population is the which interface The the

Now, to me back it let Sujal. turn

Sujal Shah

Thank to to we all FDA. on have only on have regulators, you, it behalf not we is our of including Based been discussed its process through Chuck. of learned that our see believe what analysis this obligation patients, an we The investigative but elements have completion shareholders. date, prudent, stakeholders, with our the to and

presented addition Phase this few seladelpar's that, with I'll our years, have in tolerability remind in in over medical shared safety and at PVC from past highlighting have meetings today seladelpar to patient its major the patients we efficacy, in NASH, population. you the II data we you

including potentially the a a a activities, development based In we or clinical parallel asset of have alternatives strategic evaluation comprehensive additional all value, FDA. investigative on to a of acquisitions sale, maximize with discussions to on focused shareholder our been liquidation, seladelpar continuing merger,

investigation, committed remain seladelpar. order is to believe forward prudent in clarity evaluation we potential for to decisions on gain once expeditiously While the we make the completing this path we

all stage. doors this open we potential In words, are at keeping other

Since focused have series our announcement conserve last on to cost measures cutting a been and minimize we November, also capital. of expenses

and you I'll of overview our Dan? financials. with quarter to and Dan an over review turn to XXXX action full-year provide it fourth

Dan Menold

Thank you, Sujal.

and order program decision operating seladelpar program the to associated restructuring management and in during on implemented the quarter Following burn. containment our to cost cash the hold, expenses a place fourth reduce

procurement future reduced our services. scaled Specifically, by for many we existing down and scaled goods hiring, back than contracts workforce and plans, canceled XX% our of froze significantly more or

recorded fourth stock with manufacturing costs, charge severance As expense includes employees, a result of of these of the actions, contract $X.X which restructuring million of quarter, of based $X.X during associated of million with million non-cash charges certain and terminated a $X.X termination million employee certain the acceleration agreements. $X.X associated stock the of options compensation we

remainder in paid $X.X restructuring expected be total the paid of over charges, million $X.X and We out course the are million Of be XXXX. in QX settled these to cash. million in expected $X.X of fiscal is the to charges out

of financial and results. of I will briefly our full-year now elements a to QX review turn other

was R&D million December and $XX.X and of expense Research the for $XX.X same million compared $XX.X development expense $XX.X for and million the This X XX, to respectively. in months million and XXXX. XX ended periods XXXX

million in XXXX. respectively. development expense for million months and million $XX.X the Prior development halt This same and research R&D compared for $XX.X seladelpar in and million expense XXXX, was $XX.X XXXX the and in X of the XX, December to ended $XX.X periods to November to XX decision

Development the than Phase in and November II quarter clinical Prior of ended months clinical III halt higher XXXX PSC related activities fourth PVC seladelpar XXXX, to XXXX expanding generally studies. in clinical decision to trial due to research NDA enabling our and Phase expense in trial was the to our development XX trial, and other

XXXX XX, and December and $X.X $XX.X for General ended to in was the for XX administrative the $X.X X and compared $XX.X million respectively, million XXXX. expense million periods and months million, same

Prior higher decision in labor months expanding and XX to quarter administrative development XXXX costs to expense in XXXX of to activities. the halt necessary as our than seladelpar, the a higher expenses other of development result and ended fourth support was G&A

for XX share loss $XX.X respectively. and million This was loss $X.XX for net ended million ended to XX, compares our million net December $XX.X share and XXXX. XXXX share $X.XX per diluted $XXX.X XX, and Overall, or or XX diluted December X and of share, the or $X.XX $XX.X the per $X.XX diluted per per million or months X months diluted

to year for including restructuring earlier. as in periods prior and The in loss discussed the quarter our increases full-year fourth operating net due expenses, our the compared XXXX was charges, primarily increase to

and with Finally, in impact outlook the of the burn. those to like XXXX, and cash our you activities I'd expenses our our position, expected operating on cash activities current share planned for

XX, XXXX, at had $XXX.X cash, equivalents At hand compared and investments short-term XX, million we XXXX. December $XXX.X to cash December on in million

of seen As management a strategic observations intends focus NASH completing and in options. investigation to concluding noted patients earlier, its in review on of XXXX, clinical the

and In addition, study ongoing activities. work monitoring complete to management clinical will closeout

site visits recovering These early clinical with monitoring and monitoring patients data and product, observation, investigator and efforts, patients, analyzing accumulated activities reviewing, NASH including conducting on involve a number reporting investigational key caring visits closeout with and drug histologic termination to date. for trial of quality performing

of estimate Consistent $XX our amounts to provided the first burn continue half our cash recent between previously in letter million will be for our with to and overall $XX million XXXX. shareholders, we

previously be we will total, $XX the and and used study expect monitoring this activities Of fund clinical patient investigation million to between closeout, $XX million seladelpar mentioned.

Let to final call me Sujal? back remarks. the now turn for Sujal

Sujal Shah

path to and Thank time. this reasonable you, engaged has I been forward Dan. believe I sensible most we we hope update in helpful. the reiterate this want at are that

learned be on potential investigation provide ongoing clarity situation year believe the to forward. path the There we half our is still in much and in first of will this that

seladelpar continue ensuring are what to of findings, know The clinical strategic evaluate is about given action, our that parallel, also, we best assessing we course alternatives. in while to thoroughly

While in the soon to to commit too our the is strategic unprepared value. event be emerges way it any option, maximize in as shareholder caught will best certainly we to view, specific not this

Before remind corporate that has for everyone today's opening the of I'd on activities up provide financial call to call like and and full-year quarter results. our fourth been the our to questions, updates purpose

biopsies we detail involving ensure be share can way, this order discussed have we is In to beyond blinded patient not the influenced any what investigation we reviews far thus in ongoing limited in will activity today. independent what of on with

Operator?

Operator

[Operator you. Thank Instructions].

of Rahimi Partners. Yasmeen Our ROTH Capital first comes question from

Yasmeen Rahimi

additional Sujal. Hi, Chuck. the color. for Thank Hi, you

for questions you. quick two Just

give is, give placebo initially reading biopsy the the beginning these regards at us you the placebo and baseline of bit of atypical samples if end the Did are between and time. give just at a The can pathologist reread lesions at you that, are to Or a can't the basically a treatment us exactly of have walk arm more through treatment? color seladelpar, between Can the treatment, able you numbers in end is little one second sample first us at where how read? you the to and the score?

of kind us. how occurs that could of the very you. just be helpful for logistics So, Thank all

Sujal Shah

and details Chuck jump ask to highlight you I I anything thank missed. can these question, Yasmeen. of in with certainly Yeah, that some the for

I time, You're amount At absolutely biopsies some to respect interpretation experience earlier, pathologists an think I point share is by as in details NASH mentioned world-renowned these some assessment as with in of with of to of incidence will all unexpected findings of we confirm correct. significance have end-of-treatment. the as well-known and and to these independent tremendous key as get the part for baseline well end-of-treatment the to at the us blinded findings. through both of several a ultimately But

So, it's important until take the We think of of we that through particularly we the review and for us panel yet to that the integrity won't to share just it incredibly get maintain ultimately we to agency. element investigation. them investigation, the as

pathologist NASH both read, and a – With end-of-treatment we do respect to the the screening a in same biopsy pathologists NASH had all had biopsy read experienced that reading, single and pathologist biopsy. and the – well-known we second

the At is, key pathologists That point this in this pathologists by those point time. in treatment independent end at time, biopsies. conducted we've not activity had of baseline specific particular, the reread any in being of either several or

Yasmeen Rahimi

only many and Are Thank pathologists. this the you with you, handful sample? to certain there comfortable part of a are helpful. pathologists for That's at how are us the I'm very well-known total color. rereading of share Sujal, consortium of looking

Sujal Shah

several have completed. we Again, that actually Yeah. once mention folks this we'll is

prefer we course share do results analysis, their independent the of which to of I we maintaining do. so interest in the we'd review, will their think, again, of as

the as and prepared with interpretation have this think, clinical to, taking goal the second study same and of of in of before review effectively expert the QX. the along the have agency is any our conclusions of experts pathologists ultimately room investigation the middle review in I mentioned the and end plan with a the that the to of to pathologists results in our remarks, conduct quarter, back in some sometime the interpretation these with I meeting completed and panel fact, results

us review. So, through I individuals independent their really we'll those think to that, let But, again, just for get it's do Yasmeen. important

Yasmeen Rahimi

this. digging deeper into luck you. the of as Thank you guys best are And

Sujal Shah

Thank you.

Operator

Our next from Cantor Eli of comes Fitzgerald. Merle question

Eliana Merle

so for Thanks through the taking you from of us questions. in the sort guess could of terms investigation, guys. independent the range I much Hey, sort outcomes of scenarios? range this walk of of

sort what I with looking this, discuss that potential then, discussing to maybe be prior in if the terms about indications FDA so you be the findings of or it's different seen to meet far each And role shape and could you guess, this you're you in and different steps you've potentially this in of how at impact next what mentioned indication? says guess future how do seladelpar, I and would plan for it. the that

incredibly guess, you're terms just digging into this then, And I in obviously deep – data. of

of Just, uncovered I guess, dig what around profile? have Thanks. maybe you as into have events so comfort more you safety these sort safety far might you given that the

Charles McWherter

Chuck. is Eli. Thanks, This Yeah.

be hepatopathologists, I review by liver hear regulatory participation length. as disease injury, that to vital think will with the expert We posed experts or clinical arm's to independent, but have a theme length a think we will It'll that had been well whatever There'll regulatory we've company to drug-induced itself completely questions as be in who've decisions. panel the panel. with be you're association But then the includes sense, in way liver hepatology who panel completely agency help only But the the and the that the inform think. be this a give not individuals study. any going arm's that been NASH, here, there well, determined including it's as experts and approaching can developing recurrent minutes. probably There'll we're is you individuals I experts other involved the in really since not study. seladelpar cholestatic just

that, to speak light think the So, that in want options. I of really don't to of range I

possible. everything is think I

development, concerns If as hand, that'll for consensus other make the be causality determination they that for of well. could their consider that'll agency recommendation. have be risk hepatotoxicity to be it's We that do the that if based feel with on appropriate shared and upon they the seladelpar contemplated the view their if panel, a

rigorous, that's this to review the for the for required kind really seladelpar independent forward. to comfortable happens that and agency level move be that very science-based a think if is strong of We would what taking decision make

light, really might that to on out. In I I want how comment don't this play any specifics think about

that in take those so be made available, when are the I results that best it's, appropriate investigators, we course, done. thoroughness, where in them. for created to I that what invested can commitment responsibility feel, the think the call, of hold value for comfort the shareholders is importantly, think that's patients, study, the I that to you well, people ultimately be And will the we our on this integrity, regulators the because as is could for who've the think and, quality, just

Sujal Shah

Eli, just I'll of you bit of confidence. add, And, as a question asked maybe our around a level

of have November, at the additional are think in study, effects collected, expressed when histology collected as signal in it typically we've it making have that we end that on see that of collected seen in sure continue injury, I population you baseline. that at a biomarkers of markers, the liver our Chuck we fact but as this still additional back and not endpoints a fulsome as not really of well. to We're patient just drug-induced investigation. the host biomarkers but discussed those be guides reported we But been understanding today, biochemical shared us any not today midst also well. to just we've across specific We treatment, yet elevated

benefits today. reported seladelpar I the of the endpoints hypothesized what around histology to we anti-inflammatory translated think have we some of

alkaline that So, of weeks at effects XX seen seladelpar phosphatase patients. worsening we resolution the And histology improvements at on liver of without AST, for benefits these NASH again, GT in we've portion key I with in decreases a think have to NASH, least robust worsening into fibrosis without XX maintained gamma see, fibrosis, of of through and translating been weeks. ALT, respect and enzymes,

we we picture time. that the a of really integrity at on investigation its to focuses complete making in the this of independence it's complete same in continue and learn that maintain So, that what investigation and sure entirety

Eliana Merle

much Thanks for the color. so

Operator

comes question Raymond of Our Steve Seedhouse from James. next

Steve Seedhouse

community. the end-of-treatment Thank to for the you. for assessment. those commend look share results into with the and data Thanks. Thank from the want to just you guys reporting continuing I histology you

with it endpoints, response NASH as and signal liver is had liver thought obviously NASH to enzyme the correlated remarkable you I that and changes see the which mentioned, fibrosis correlated was a dose resolution fat. after with just inversely all,

I'll I the the for investigation. to had doing patients one how And try it patients interface few just first are that the correlates compromise hopefully clinical the questions. So, had subsequent ones there been that is keep problems the to blinded to any wouldn't finding? hepatitis? a Have these or ongoing

Sujal Shah

Yeah.

thanks question. reported. To there haven't for complications further date, So, any been the

have place plans Of had particular remain biopsy last investigators and recommendation the repeat those do after finding protocol in for the with drug. a six a months follow would to continue engaged and subjects we to for course, in patients. we We dose of that a have occur who

process that news I anything good say. is date, no It's to so, still And ongoing. report have don't progress. to in remains would now. But, I news,

Steve Seedhouse

something you. yet have is molecule remove that i.e. on the thank but from an to PPAR-delta i.e. looks efficacy? could do Okay, by if be the specific, pharmacology to related you mechanism opinion the improving what molecule, retaining finding And specific, or you

Sujal Shah

what think I is the of just happen. whole to out independent did figure the review point

the was caused. about So, until the step what want go we cause I think understand don't to to what I next was

answer So, mouse this. multiple models, I'm of like in our an preclinical any obese findings will defer seeing I that. work to all going hadn't just to we mention NASH in that

yet mechanism still the not, of itself So, is mind my linked. anyway, in

independent additional any then the completed or recommendations us is the panel follow-up. that So, comments appropriate until have for on we'll an review to think will just wait make I be and to to

Steve Seedhouse

could the exclude this possibility one causing that's the Okay. be next that that a study, from is interaction I'll investigation? phrase the a you little of design drug-drug able this be signal? one are concluded differently? could possibility Or this Given bit Maybe to the that

Sujal Shah

we've these concomitant findings fact, remarks we like if with you factors medication, think the any yet related to to conditions, in I to look back treatment. time of at unexpected as patients underlying at Well, made point end of of at some history, in pattern, medical see go other we've things this

picture around in we much shed significance where today more independent a the potential most is where review this again, scoring are unexpected review will light of but that also independent end that not any to respect depth include any fact position of system. specific around systems So, the these at treatment, typical findings, these a scoring used given are this in are provide with specifically findings will the part that causality, NASH

untoward. Chuck that to think or in sees But us or degree of Modified investigation as a our framework So, with of if the involved unusual has studied here in in-depth the to different not methodology the respect a several different one population. such HAI, in Ishak are respect called with things features Activity that pathologist information other that and pathologist is which we're including typically you I will study using Histology components Index, to give number the as something mentioned, amount than are hepatocellular scored necroses, out quantified, tremendous and hepatitis, additional quantified, that interface NASH will,

Steve Seedhouse

would finding, is Okay, this like, obviously, one I maybe uncover you Last thank for is, observe that. that find – will me. to believe the hard investigation this it it but a you. NASH-specific

PVC of lot a patients treated with obviously drug. this You've

post ever quantify in of you assessed can PVC how remind that, you seladelpar if the you patients so, those just can during many have And biopsies? So, biopsies us, in treatment? development

Sujal Shah

Yeah, I question. the sure. Maybe answer can

It's into subsequent in point, point at extension, biopsy the to In histology study, disease. part The practice part would perhaps to intention change any baseline we Phase III medical the that, PVC. not in if the second opportunity biopsy. did a see patients past, enhanced example, time our of is opportunity there's time fact, to for necessary, the histology. clinical in not overall long-term have study discussed any biopsy diagnose patients to have of So, enrolled been studies, or would take It's a volunteer in we on have benefit some that offer as three-year not either. to as that, we in a

really development. not within part part our clinical it's of been not of So, medical of the It's PVC. setting practice

have have since you physicians patients call, these don't for baseline to had biopsies patients. November's have elected of We approximately dozen for provide However, to with update an which taken. treating we biopsies all

our However, that we by in the based they described and/or PVC. not to We've those anyone's appears assessments that those atypical. respect within do with PVC that study know as identified physicians populations with pathologists centers, to histology anything being yet on consistent seen us

Steve Seedhouse

helpful. very for the guys taking questions. Okay, you Thank

Sujal Shah

Sure. Thank you. Steve.

Operator

next comes question Olson Our Jay from Oppenheimer. of

Jay Olson

Hi. there for biological a And it hepatitis? correlated a the seladelpar even finding with for taking to events? role Thanks if this possible potentially that any or it any it explanation, seem Is that is causal liver be is questions. support would interface hypothetical, of were harmless since adverse injuries didn't

Sujal Shah

and well this characterize to is comparison really independent one seeking se. point, And a would very at way, would as both the along any that the relationship interface the say, have would to I this I'm treatment aware particular, baseline. point, I as PPAR-delta in on that, say not per placebo we're again, to compared things lines, at in of entire again, expectation that understand population agonists a of study seladelpar, in to

elevated didn't drug-induced We've really line interface before. almost it this. think injury I have more with expect often or drugs like AST. liver Typically, have some We that the ALT that. So, that correlate is autoimmune Drug-induced been have that's is. DILI include They advanced typically seen features clinical hepatitis bottom and associated liver necrosis. would associated always never with disease

also bilirubin, elevated clinical Sometimes symptoms. but

there's discolored pain. flank or see urine, would to if jaundice, expect rash, component, drug And you often would maybe an often see, allergic You for eosinophilia. a example,

a of picture, expertise and aspects and histopathology staging done in reasons system range picture for is were laboratory why the features a broad with also pathology we've characteristics, study the this seladelpar with all clinical and those of the none so, the for out. and graded one found but only the we investigation And initiated picture, key, experience not this thorough the of along in that's this of bringing think, using we've such sorting

Jay Olson

about if trial talk to And results the support another these agree results seladelpar Phase these could thank a were a If for clinical or hold NASH? conduct maybe support pivotal Okay, could IIb study that. do think you on in remove Phase FDA to the to you need you do IIb you'd pivotal study think then, trial. development, would if you

Sujal Shah

a That's question, good Jay.

seladelpar, have in we us it's look required. are results will the histology statistics actually look translated These think if agents you what think have ALT, across what both to in that press quite the premature and fact, again, at what have are to are benefits preliminary, alk in in are as gamma studied I to for well speculate else would in at otherwise so included we this just AST believe across NASH see, I be release. XX the bit quite think say, translated. see expected a changes we improvements we GT population, we date, in other to meaningful. our But to of really fact, seladelpar been pleased liver as have to not appear that be and on enzymes that would in weeks when benefits we anti-inflammatory of I phos, at the

be. about in to would about occurred think unsure again, what's the is really path I for primary opportunity focus But, our and the about forward to forward learn potential have I'm think So, here what indication. more seladelpar paths any next

most was indication course, advanced PVC. our Of

with simply say, we're that to a to is date, we've efficacy. what priority. with pleased So, respect But I'd seen

this at are steps future think point unknown. I

Jay Olson

very great. Okay, Thank much. you

Operator

of question Co. Our Wainwright & H.C. Ed Arce next from comes

Ed Arce

detail And taking and analysis Thanks for Chuck been today. the questions. extra for that very Sujal. thanks provided helpful. my It's you've and Hi, all

major of I So, sort questions. have two

of to effort First is, clinical clearly, to you've seladelpar. of detail all date some findings really and the delineate taken

the immunological no of signs than or There's improving how biochemical there's dozen signs no or or more all potential You've are markers mentioned platelets factors, or so liver-related DILI, coagulation stable. of AEs. signals no

key that so, signal, then, possible around meaningless And caused and a all are that that, somehow determinants A, here on of the happen of one kind June, or light And by B, that, is findings from we've not panel or follow-up. think findings guess, of this histological it or first May of were findings have the – I is, I in in I atypical is would a seladelpar. one it but is, real, question bit call the of the determinants the actually a really either, the that danced false

Sujal Shah

Ed. really million a I I what question the we believe it's think dollar asked yes, it's the investigation Look, answer. is question, you've Yeah, and think, to good geared

of if something be as treatment. the think to likely latter, there move seladelpar the scenarios it in I fact, forward out most of there's you at potentially, path it opposed to identified, a caused wasn't if would end not being that, by two

beyond us framework patient think more both give we're at again, baseline and using will in is typically a population framework a the understanding histology And in biopsies to the that what is, much of assess even fact, I that goes NASH review end-of-treatment baseline. that clear done

the the company. on So, we're fulsome, key priority through incredibly the panel making focused all within fashion, review to way is, review sure happens executing a a agency fact, the in the in committee that and independent

Ed Arce

Okay, great. Thank you.

of of had depending, pending. panel's part course, top here outcome the you noted, results Most of line of Second still to you have sort parallel from on have this, the And, the are study. related patients obviously, as biopsies. these preliminary statistics work, the this

terms of mg anything all that it's least have fairly sig. across in being So, seems in we acceptable to endpoints up the in three end clear it perhaps But me stat these of sig, to at surrogate NASH. dose, stat XX don't likely

final have positive the not been gotten find you with the results and the panel with final finding statistics? you what I you've see And cause this with the here next final the so, drug would forward once once of preliminarily, determination steps going that you've given are given data this, could may direct efficacy the this gotten from that determination? fairly seladelpar how guess

Sujal Shah

for had strong PVC hand. think then data, a go in I always we in there's Phase think that, there's the out population. fact I'll medical Ed, II on independent setting the in we NASH, data, within pending in perspective. unmet to panel with getting and an agree ultimately but dialogue of say, where clinical other need simply with study. we're just of we advanced, furthest you, to need we the unmet and With review to we've clear efficacy clear the come with data again, indications, the in a from our here, be the argue We of felt we that in PVC of also focused that'll in in set independent with respect NASH through interpretation strategy review this also And seladelpar, around review of here. if is the the the fact, to listing encouraging really engaging results this most back in are know agency the not hold ability meeting respect I the

various NASH, I to felt respect combination. that treatment studying alternatives we've would think involve to develop agents in with strategies always

supportive I data be think these potentially of that. could

want don't put the so to the cart to I speak. before horse, But

I to engage want path the is get pending the us and, of to the for the investigation the agency minimize on focus the I in through key the element don't maintain results, think dialogue. ahead us to investigation. further

Ed Arce

just there Clearly, I moment take here that here. so regardless diligence done work signs thorough you've far to to on a and of congratulate great. outcome. some are your want Okay, the encouraging you the And

Sujal Shah

We appreciate for support. the it. Thanks you, Ed. Thank

Operator

from question of next Our comes Derek Stifel. Archila

Ben Porter

taking my Thanks, great. Derek. Thanks This call. for guys. Ben is on Hey, for

missed I but in second XXX you the a was for give patients? of the biopsy if did done out XXX reason Sorry why only Thanks. this,

Charles McWherter

XX% IIb would end-of-treatment Phase It's Yeah, I a had That's of biopsy. paired or study. an the subjects had study, number, We pretty biopsy is about thanks. for who say, range This to common Chuck. a usual. a XX% XX-week

to Some terminations early typical was of related lost follow-up. or for to reasons this

a again, to terminate study did, second in And don't we early. Sometimes, the patients want biopsy. have November,

that another patients interested going they And impact so, that just were decided through. then not that also in was

XX% I So, a number. perspective, is in good my pretty think, XX%,

really doesn't that think from I raise flags any our red perspective.

Ben Porter

for guys. thanks info, the Okay, it. Appreciate

Sujal Shah

you Thank

Operator

Joel of Citi. Our from next question Beatty comes

Joel Beatty

the thanks taking Hi, questions. for

shows Could done for for that is The what remaining potential you the the that in any are change? release Is there needs what's to table statistics numbers be first to to on that the analysis. final compared share shown press data there shown? pending one a the analysis final

Charles McWherter

very just clinical being true good Yeah, question, processes. to the abundance Joel. practice and an the thanks for caution It's of about

So, locked. yet the database is not

the the good to need all control, quality cleaning, typical the clinical study final things a in of types that process towards we're of move report. So, us

that's to understood to and recognized, then according can the once done And to so, be have we that analysis didn't modify statistical all pre-specified want plan. And later.

are results preliminary. The

would The possible if be be significant. really I change interpretation always anything that would all. it shouldn't wouldn't overall could it's consider it there some adjustment, that – anything wouldn't be any So, think changed, you at but

Joel Beatty

FDA collected data Great, is, how PVC. was that thanks. And one and going close I'm support you if the Where's lift amount Could clinical what you Could where other trial? of on trial data agrees doing per the trial point guess could it us question support? you patient? to I data get Could support where the to that remind that another a to at? hold, approval? it completion

Charles McWherter

And great sentiment question. Yeah, to the what we agree alluding with you're there.

data significant range it's reduction but months, from sites. and – in months that a that had markers, bilirubin looking the the in numbers X historically even was than the many be and across that at nine We alkaline treatment months, I'll XXX very through six as and through see a normal little the we endpoint by phosphatase difference be XX% be X would full that XX XX a between just set of than between at it could you used we in had while in months, least through regulatory studies trial and in by enrolled. that a baseline phosphatase a enrollment fact completely treatment significant would trial, there's usually what more decision. And at XX months. registration of believe more particular, consideration itself cholestatic with unlikely very subjects for of study so So, countries, composite below X.XX primary alkaline is you In study that part support a remind

Again, endpoint was secondary normalization phosphatase. another of alkaline key

would And six-month that then, importantly, months, Looking at improvement in be pruritus, think was six endpoint. a that, and informative. at I very

placebo so, set data would think And controlled that. a just we very speak would we that full really to have

our of in experience And we're very just accordingly, extended. which was II clean, that the up, we've the study, So, A we measures XX-month with a that coupled our question, to the used could out we study. that answer back I collect to registration go there, your open is were in terms wrap to out, data, clinical be enormously get we that a would label Phase can into be, event report make study a which clinical PVC and round clinical think, of study, large close also it to the taking we with that valuable. lot data sure

with far efficacy, – than a years of with years of and have treatment some tolerability, patients of two We past patients treatment. so lot of at past more safety. of least XX good patients Even appearance in terms three results the

Joel Beatty

Thank Great. you.

Sujal Shah

you. Thank

Operator

of from comes Mamtani Riley Our FBR. next question B. Mayank

Unidentified Participant

on question. is got I've taking for Thanks [ph] Mayank. Wei This ones. quick several Hi. my for

let you will and you The will do a study. on if ever the us NASH analysis? dosage be Could first [indiscernible] know was what Pro‐CX level seladelpar

Sujal Shah

you part that? you Can your question first of the mention repeat Can sorry. I'm again?

Unidentified Participant

study. level dosage what were Just the in

Charles McWherter

and milligrams. in we seladelpar NASH three studied So, study, different XX, doses the XX of XX

again, more important reviewing, independent time, findings, this and pathologists specific both related at question it's in those to to is disclose not with we several as If patients end-of-treatment think details we again, baseline unexpected biopsies. your point have

the And their that the share so, to to review, influence not we'll of independent investigation. subsequent completion

Unidentified Participant

how Thank you you. any analysis? to the also, And that? Are Pro-CX going analysis about do on

Charles McWherter

I rich very and including and imaging, had corrected-TX. think study non-invasive MRE the of extensive assessments, a set

shared some have data, biomarker FibroScan have be some point. fibrosis including Those do data. We markers. We at other some will

to publish But study, until results. we're of like entirety be to make them disclosure the external that think ready eventually studies, our like medical plan the and for up. would results review, wrapped to conference, get yet all the we our I the of not a everything bring

Unidentified Participant

NASH let a baseline then, treatment? know remain as us any Phase could period such treatment, the if you on treatments, background excluding washout II the allowed And lipid Or the et to thanks. if study GLP cetera? and lowering had there patients was Great,

Charles McWherter

GLP-X. on weren't they So,

of for have many terms making would, diabetes, subjects obviously, could as these during appropriate types adjustments of kinds they per of And limited those comorbidities, different what they of including protocol. kinds were study. all were conditions. But, allowed they allowed be underlying And though, in their not therapies So, things. GLP-Xs this hypercholesterolemia, be the

Unidentified Participant

Okay. the PVC more maybe for status on Is the PVC a timeline this meeting? of there June for set? be Could give on available color And will you study. my any last data follow-up be May the or III would question investigator us that Phase

Sujal Shah

It's a question. good

previously announced completed. and needed December. And be don't We So, for the as Chuck the that cleaning is database those data. review. particular that we that last integrity maintain The mentioned, to as believe in is timelines again, want study, data we of we've to panel terminated lock and yet the

community, the in would overall successful regardless it we think seladelpar the It some time. data share I share forward think, point helpful I to be near at in but us path in update should with would be, not finding our PVC. to for certainly something be the for in intention, just medical to a respect useful to

Unidentified Participant

Okay, great. Thank you.

Sujal Shah

you. Thank

Operator

like to This concludes Mr. the Shah back remarks. session. for closing question-and-answer to turn would over the conference I

Sujal Shah

on today. again, call the you once everyone, us Thank for joining

providing we're expeditiously further all these of of you. across each We're streams. incredibly work efforts, Thank we progresses. diligently patients, regulators updates we've noted, And and to the and our mindful work in as including of forward working parallel stakeholders our As look shareholders.

Operator

This concludes call. conference today's

have you Thank lines. your participating pleasant day. disconnect for a may You and

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