CBAY - Earnings call transcript Q4 2017 | Cymabay Therapeutics Inc

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Operator

Good day, ladies and gentleman, and welcome to the CymaBay Full Year 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call for your questions. Please be advised that the call will be recorded at the Company’s request. It is also being webcast live on the Investors section of CymaBay’s website at www.cymabay.com. to call like to now would turn over the Mr. I CymaBay. Vice President, Menold, Finance Dan at Mr. Menold, proceed. please

Dan Menold

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

that Pol access review website our we Officer and McWherter, milestones. update results. Dr. for on Boudes, on Chief up on tab. our Shah, Chief Chief then under are Officer Chuck the I the call Medical who will summarize today programs release will provide an Sujal Investors After clinical Scientific Executive Participating can our You will the the Officer, call upcoming Dr. Company's financial prepared Q&A. remarks, and open

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

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

Sujal Shah

been you, everyone. CymaBay. Thank for year has afternoon good transformational The truly past Dan, and

efforts that prominent international as Liver data the believe Disease tolerability October that improving Gideon diseases current second the are around PBC The taking the for featured was patients was of hosted by PBC our potential patients patients with summarize our to over is today. with which the asset, with have the our for Early improved align cholangitis arhalofenate a seladelpar We We expert in us the in our seladelpar and XXXX. again of steps American XXXX, product to X our the focused announced or Meeting The to Hirschfield lives Association towards primary of development NASH. company and data with for PBC. steatohepatitis the we patients Liver focus in in a Support medical that by liver at better Phase consecutive late seladelpar line given what biliary key Professor of Interim non-alcoholic or year and PVC pipeline now second will development important this presentation offer mission. data out-licensing and at ready X allowing gout from This activities efficacy late featured PBC Pol breaker advancing treatment was study congress. lead-clinical our seladelpar from in breaking briefly of for in candidate Study Phase ongoing

in made senior hires activity. support our sheet including balance year key also Over we increasing the strengthened past to had management significantly and development

the X the initiating the step to second CymaBay Phase study develop year look to as Phase begin PBC in to initiate America. arhalofenate, Nash. to the a key to seladelpar a and in half commercialize ahead, is program year diversifying development with As a repositioning our of by poised rights of forward A CymaBay and liver in we license seladelpar Kowa study Xb the of out Pharmaceuticals U.S. proof-of-concept of in focused of company

we the We of continued additional the with was milestone of related In Kowa’s pleased to advance of of commitment our this an for gout. payment. January, criteria milestone This patients arhalofenate million the $X a initiation arhalofenate are study key to X arhalofenate towards enrollment development that with treatment. receipt specifically from year announced with subjects renal of development. available Phase is this trial which Phase in step could potential have impairment, pharmacokinetics the currently for a inform a evaluating to differentiate from study X Data further

limiting acid for synthesis. that in as on These pool. Now its focus potential are a and potent enhancing diseases well demonstrated potential before bile with cholestasis seladelpar cholesterol the gene acid hepatocellular results. PBC. toxic reducing XXXX in and synthesis receptor absorption. decreased clinically In a treatment the of disease We liver Together of updates effect together dietary well our in the anti-inflammatory Seladelpar bile also review closing benefit shown highly Seladelpar PPARd. believe NASH the The of which both part improve Thereby for a effect of of XXXX, the with activity the treatment let us delta been receptor a accumulation as the for PBC. down amount have results to for and been proliferator-activated acids. responsible including effect the has seladelpar as encodes biosynthesis or for rate agonist cholesterol of from substrate acids. patients nuclear enzyme on bile particularly of financial PBC suited is regulation bile selected these peroxisome decreasing the and of decreases in to of inflammatory the seladelpar synthesis total seladelpar available by this synthesis decrease is

duration milligrams profile In regimen the in published doses results journal the second in treatment the at with August were in prestigious over peer from be mechanistic broad one XXXX years, seladelpar. as for daily presented & established last exceeding were of XXXX This sight us we program. October PBC of from into earlier studies can PBC the study two a in carried from potential our Lancet two doses that convincingly that in to a XXX And the into with Phase patients review examining first AASLD. Over year. we the X as range establish patients mentioned benefits collected also data have Thus only has believe and allowed but results to Gastroenterology two not now well we actions have Phase benefit dosing and that identified The the Hepatology. demonstrate some risk from as X proof-of-concept study

seladelpar of and was a we during and and in results the at XXXX. Our today ongoing Pol Phase updates made cornerstone to I'd like shared program. to provide X, to progress over PBC of upcoming call summary hand study the the activities Pol?

Pol Boudes

Thank you, Sujal Shah.

study study Acid. dose with X first is our seladelpar efficacy have safety intolerance in to long-term treatment. Patients seladelpar lower after response extension a orphan receiving study enroll evaluating complete therapy, our Ursodeoxycholic line can PDC. label PBC in year the study one ranging all reminder and inadequate who the These in As Phase this a of an patient patients of to second an of doses

our our second safety long-term recruiting to continue to X is database study with initiate X build as in this of Phase we patient, clients parallel year. actively half in While Phase the

program the long-term appear drug development and treatment extension without we who seladelpar the as receive from study, patients option interruption With offer progresses. the benefit to to continue

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offer the a in Additional Pruritus medical patient seladelpar highlight PBC highlights potentially markers affecting as itching or quite the interface other of require levels. reduction seladelpar sensitivity be and The to bilirubin Phase of reduction PBC the seen is to positive level This between in better results induced including GT disrupt severe course studies off PBC. dose can improved feature and some potential second as important observe severe differentiating line effect drug data of in key inflammation and is often X Pruritus low level XX% as reductions our both Overall it efficacy and reduction of patients, and indicates transaminase problematic the pruritus. frequently enough marker of treatment that in XX% activity of such of daily and patients. of a CRP in study cholestasis is the tolerability absence intervention. to very of interim patients. hepatitis potential transaminase including the with for differentiated in high sleep from is a PBC in gamma

X XXXX year. Our initiate second the to plan for is a the in seladelpar Phase program of half in

a new We in finalized. PBC. data requirement with at safety study will an dosing, X by update design expect EMA learn efficacy to can continue timeframe provide that gain or XX presentation agencies Congress up In study, are the be the Phase with in April. International consistent as the to of consisting to both the and data a on meet FDA of week, Liver X European analysis month our of the we the EASL pivitol plan that XX late-breaking and both Liver registration of to and for Disease ongoing trial Last discussions in we collect this used and once this agreements Phase of that the a the from is Association XX featured study week poster Study the sponsored that’s Ocaliva

competitive highly the extremely category seladelpar, PBC meeting. late-breaker ahead. the pleased International We results are third update forward and in you that most be running year look will Liver months at EASL further Sujal? the the We to for on at the in providing clinical with featuring program important

Sujal Shah

shift gears have I half Xb Phase would plans about now NASH and of proof-of-concept to like collected support first of in to ask we our to that so in far study year. data seladelpar the talk Chuck initiate our the this briefly

on PPARdelta NASH. the as progression We anti-cholestatic Chuck? from lipotoxicity Aside effect know an of well increase otherwise regulating agonism. as the and inflammation processes in results mechanism in the in this effect of that metabolic has fibrosis implicated direct

Chuck McWherter

Thank you Sujal.

that Australian many fat of fact are diabetic pathology. the obese Barrow about area antifibrotic are interesting clinical in as for that the to particularly significant That drug were inflammation Jeff with we're wanted metabolism activity a is out its design lipids, a in As reduce multifactorial and because reduce now in mechanism to a of as a and results preparing model seladelpar toxic The to published coupled hallmark stage and of his in mention mouse Glucose, University characteristic on to of number last in well conclusions, with is which NASH trial. sensitivity. sterile the study Xb seladelpar the provided NASH. Hepatology the we liver lipid is of our controlling Communications. National of the results late disease currently of I team know in Among PPARdelta fibrogenesis, inflammation study Phase and which is What the ability and initiate. endpoints action the peer-reviewed in there at of especially journal in insulin the role collaboration you the interesting summer specifically metabolic NASH NASH the dyslipidemic hepatic the ballooning in the point the I impetus and

antiatherogenic obese an milligrams of in and results Our examined study Clinical in alone This of doses seladelpar supported potential confidence both mixed The XX Phase seladelpar in of Journal atorvastatin. decreases in the X features. markers. obtained Xb And a particles dyslipidemic and we describe basic pro-atherogenic patients with is reflected more XXX and details eight by study activity bound in as Metabolism. Endocrinology of seladelpar combination around week the to published other We’d soon of was in LDL-cholesterol in Phase have as as an What to in and few well intend lipoprotein triglycerides. like inflammatory the design. study mention NASH to

targeting recently we're disease key week. a And the with biopsy. looking First secondary baseline of in sponsors. will noncirrhotic We confirmed other at levels, hepatic such end have and of NASH dose by background looking XX disease similar news using biopsy MRI-PDFF a These pathology will fat stage outcome be a as change of NASH the a fibrosis endpoint from at as ranging at an population. we study co-morbidity placebo-controlled study in diabetes patients be by with plan to primary

this we're this are study. planning seem and is of for inflammation What the endpoint closely lipotoxic to particular, driven to hepatocyte In ballooning, be We a be affecting study. strongly currently that are of the mouse were linked exciting and mechanism focus this the expecting our fat of liver these model is particularly seladelpar the all to features XX-week. that

providing The in update look other look of great around you the and actions lowering sensitivity characteristics to interest the year. We as forward middle of how long-term on the an for discover potential benefit and to specifics study lipid NASH. are the design Sujal? on insulin of seladelpar treating the also this we

Sujal Shah

Thank you, Chuck.

rest had XXXX. positioned year we as in the we of are for believe of transformational As we XXXX, progress well significant through

with capital X our providing In NASH both year-end a addition successfully million $XXX.X complete our planned proceeds public needed study development with Phase in details generated more we net study. seladelpar, financing clinical results. and a last quarter fourth and With closed progress that’s to month of financial us Xb on PBC to Phase XXXX on

the turn to Dan. me Let call over back

Dan Menold

cash equivalents XXXX received $X include securities XX, balance million million under cash not compared January Cash, collaboration our with December in that believe $XX XXXX. XXXX, in public offering net XXXX. Pharmaceuticals proceeds licensing and totaled $XXX.X XXXX will XXXX received Kowa Sujal. sufficient XXXX. position XX, at year-end include America, in you. agreement and our together we nor deal received milestone to we million be does February our cash December Thank marketable it does at million equity We in $XX.X from with current funds our into current fund to operating The payment plan

of to as fourth earned in in now million of due to administrative consisted our compared expenses the million fourth the finally, the fourth agreement, a and loss or to of XXXX impairment XXXX, of expenses of warrant was $X $X revenue in XXXX. primarily development on and the prior primarily the manufacturing of of we and of quarter of share recorded in collaboration quarter collaboration which the $X.X in study. renal in revenue collaboration licensing quarter trial year, We’ve our results. of share period. or in initiation research revenue the offset our was seladelpar expenses a in of loss the XXXX. per revaluation the $X.X $X milestone quarter higher due by primarily million $X.X $X.X achievement compared XXXX, per compared operating quarter compared recorded to quarter upon fourth General the recognition to net each were was of clinical liability. collaboration to mark-to-market million $X.X lower fourth Kowa’s as No XXXX noncash expense million PBC Turning XXXX under drug and fourth expenses the and Net And loss $X.XX in million fourth quarter Research as and were of million in quarter fourth part XXXX. $X.XX of development to million the

year collaboration and Kowa, $XX.X payment $XX.X the our upfront earned and on XXXX, in was were expenses recorded to net of million million impairment the retirement per expenses year the compared December operating expense XXXX, due $X.XX to the increased our to for or expenses as $XX million Research to expenses million the drug largely was results primarily as in XXXX. loss Kowa’s a period. primarily $X achieved prior XXXX. expenses compensation year revenue noncash to liability, summary, due Sujal? from prior development December for $XX.X of $X the in as the in administrative of was and $XX.X $X.XX was trial million offset on In stock G&A and upon consisted higher received prior renal part of each year our primarily milestone collaboration XX, compared XX, clinical compared associated to to per loss year, period seladelpar $X.X million, to in million the call share the revenue. one-time General hand due our Moving of revenue Sujal. We and No in now million period. CEO former or PBC a XXXX. research The expense I’ll mark-to-market manufacturing warrant ended loss well in period. to in for study. ended for as as increase collaboration Net of initiation recorded prior for XXXX, back million $XX.X revaluation the April with compared share development by year noncash

Sujal Shah

Dan. you, Thank

of rest with by few about milestones drive believe Let I upcoming key value close that you further XXXX. leaving thoughts the our me a through will

Liver opportunity April week at in from Congress updated International We impaired. in X data and the PBC ongoing our Phase are study XX excited share about XX upcoming to the

the X with to Phase XX the update should FDA end ongoing Phase EMA to to quarter. discussions data half and with of plans study. the study in the also second second coming an the our should will of seladelpar enrollment In you X be for a which expect week have we on conclude from around and XXXX, the study X Phase addition, us the PBC In position month, begin PBC we in registration and provide the allow before over

believe as the also in they XXXX will around for Phase which patients experience to and our design growth to today. closer to with advanced goal alternatives significant CymaBay year you significant month. even detailed and Thank to another We novel bringing can plans timelines diseases from need. look We in we Xb finalized study and with look are as joining NASH our unmet share us you for treatment seladelpar coming of liver suffering

to be question. We your Operator? will now happy take

Operator

time, conducting [Operator a your this Jay with At with we is Please will Our Instructions] Company. session. proceed first question question-and-answer Oppenheimer with Olson be and question.

Jay Olson

for couple thanks my had Congratulations guys. question. of I taking other and them. on Hey, progress a

for you potentially take then will First timeline when us to it PBC, can file and could a enroll would think expect the for you you how and walk Phase through and long you please approval? when data initiating seladelpar do X study get

Sujal Shah

Sure, Jay. your And Thanks the for appreciate question. participation.

to of been questions the as then between pleased of both a dialogue we've and engagement ongoing those submission with along discussed very the the meeting the the EMA is continues agencies progress, with meetings. conclusion a while and and process So are to as EMA the that FDA both FDA responses what’s that both by know materials, of the both with currently of includes arise you confirmation level that we’ve this the itself

the about It that enrollment have as have When was single study is the first about to to to and enrollment general registration type studies typically study in the X timelines in itself Phase for that we the design. XX our months done endpoint a month period you that from look a goal as pivotal have would registration second in half have setting another the study there. both wrap and U.S. at half. in order in up our was initiate of we The the So Europe. year, enrollment this been actually the XX think study goals the anticipate, similar we in of process

dosing two looking you're enrollment to that If about study. years at the full completion a the from beginning in of of

to end in the So us that for close a brings of to study sometime of XXXX of and completion XXXX. the filing a point

Jay Olson

in population? maybe Okay, antiatherogenic of of the terms great. mentioned importance guess elaborate those NASH demonstrating you the you’ve And then that just data seladelpar. I in properties maybe Can properties of on just the a

Sujal Shah

I’ll Yes, some you detailed give to ask color? Chuck

Chuck McWherter

doing? to population. in benefit in CVD which particles, the VLDL, And lower that a But you how that in are cardiovascular action, acids, the is a population, feature outcome three population characteristic as would lipoprotein a that having in in think cholesterol, triglycerides, in which that a in of which highest addition, population. features liver know have risk. would also amount events adverse Hi, that NASH are that you basically we model, action rate think be reductions we fatty I the really pro-atherogenic LDL-cholesterol, benefit peripheral are Yes, we a beneficial saw think consider where you that carrying of addition indicate all we

Jay Olson

sort I question, NASH of you Okay, X what last That’s And in can dose helpful. a study, a plan just us thank dose do to guess ranges about think help you. you maybe Phase finding then explore?

Sujal Shah

five any down five to of our it's Yeah, think study, directed and you know of give you reflecting milligram, significant haven't PBC a we but you given can XX that as liver guidance specific we tell low as just I levels as see action. milligrams kind bracket yet activity quite we activity,

XX milligrams conducted dyslipidemic And XXX The other in the seeing a activity that comparable we had spectrum, end was to that milligrams. study we my mixed in of I that mentioned studied then of comment. the

we final expect we a of finalized to granularity sense think mixed that liver the a other the moved range range disease, especially can dyslipidemic have of fatty as into stage. obese that action and population you probably bit the in we’ll think words patient, get of in we that a more lot protocol has I consider. So already terms in our little makes But

Jay Olson

super. taking Okay, question. for Thanks my

Sujal Shah

you, Thank Jay.

Operator

Schimmer Please next Our question. Evercore is question with your with Josh ISI. proceed with

Josh Schimmer

Hi, for thanks the question.

Just the combination evaluate NASH? NASH a mechanism, the other program to with couple, that you expect, plans not any from something programs obviously

Chuck McWherter

the and treatment, I much as don't yet together the on we might engaged that development, to mind that's work on comment currently consider are know there nothing that seladelpar, that that as we be foundational approval. us I combine background really not report would know how timing treatment the something preclinically, I its benchmark exploring for preclinically mentioned, with well of they rationales in help can an if research mechanisms that mechanism, those other is we Yes, its way load, understand in basis we our will features current say some activity to inflammation in across for for lot, once finding I a is that that relative that's could therapy to only scientific time as a understand what we very can agent important metabolic it we single to a that scientific to a it's of effort all think there take that seladelpar. fibrosis. understand take suggesting that in We're mature. very I think be actively the But order around how forward But we're

Josh Schimmer

contributed to different G-protein-coupled Somewhat towards question, program, the tangential a receptors clinic to indications? NASH advance well [indiscernible] any as plans clinical

Sujal Shah

excited we're course path the this question, sit that by maybe Phase in continuing we've data proof-of-content now advance I'll seladelpar encouraged PBC the into in That’s diversify and thus a X carry quite forward where Josh particularly NASH. to about in encouraged we're today really a equally of year, singularly couple where make generated far we But opportunity focused and to here. of on good a comments

Currently continue sheet scientific to balance diversify we With broadly the particularly Chuck we development GPCR in preclinical PBC developing and least with from NASH develop at more perspective. from through supportive to of we're continue to a mentioned think both and plan as thinking development really opportunities data program. more course in knowledge clinical perspective But other for the to with today mature seladelpar. have we and continuing rationale as focus

which be will we forward in think would the future. I that updates in another providing look to area

Josh Schimmer

much. very Thanks

Operator

your with question Joseph with is Please with Schwartz next question. proceed Our Leerink Partners.

Dae Gon

question for in Thanks Dae dialing taking guys. our Joe. Hi, progress. This for the Gon congrats and is on

wanted clarify NASH to mid-XXXX. one that clarify the Phase heard study. for thought me? I you also specifics around to some regards half initiation, X So study I just with getting Can but I

Sujal Shah

Yes, goal to I actually course, study is – of first initiate the this half year. our that in of think

I year. along think framework time, timeline. was update the before protocol be you and the certainly could we again the Chuck and to actually share specific those goal just middle at study, overall finalized giving half that continue to is the an able initiate that be we will with to this the of well first The in is initiate study progress the that

Dae Gon

PBC. with regards updated label and Thank for great. Okay, clarification. to then you very much OCA And FDA for the

how your updated market PBC label of your market X label? and has result get since Phase take how a evolved changing plans you the on opportunity to as even the the wanted see Just updated or

Sujal Shah

and miss. Pol Sure. that I anything Maybe I'll there's jump, perhaps start Chuck off if and can

sure to clarify the That's B clinical PBC population. moderate-to-severe X regimen the risks broad and either patient mild C a a development that Phase of and Ocaliva. Phase potential targeted important hepatic hepatic X Child-Pugh that cirrhotic for for to make specifically or or not in impairment. patients with so-called have of and impairment, degree appropriate First for dosing population hepatic don't majority the The label are impairment changes vast I think have related us its for or Ocaliva

the for what think broader our think consistent Ocaliva registration severe across for population, intercept I we rare X the although is target more is our program relatively As conducted population, about design Phase the versus is spectrum the for relatively, broadest that very what population population. similar to study disease

used correlate specific that survival transplant-free been endpoint and have is very that towards the used have measures So population. the real outcome of prediction and that been that the across

the modeling I of the anyone think understanding now doing that’s couple but profile of in with development thinking us the after moderate-to-severe label PK registration. efficacy update as PBC. so potential things development than and changes highlight gaining safety the only importance for impairment And continues, about doing too hepatic through for a so really rather not or as to patients profile better

a it's think overall small in a but more I of population population. benefit proactive risk that understanding the

if with will a be. and warrants, the dosing think that understanding I population better would you again different overall benefit to risk approach in

Dae Gon

getting regards a very I ongoing planned more Okay, I to we trial. great. but question on to the much scale your already the be are Thanks number the my endpoint to never are guess enrolment MRI-PDFF. trials biopsy are at what of to will you plans by point, be that very large design, obviously be competitive well expediting biopsy and endpoint seems day. can you last a is mean, it the an given clarity X study with baseline an emerges as competition space as also also and MRI-PDFF Thanks mentioned taking What supplement Phase much. this never there expect given but that more will your the

Pol Boudes

Pol. it’s Hi,

the is question different other answer for – our then part is one in very and last And recruitment to want here, general I I not do is that company to we you if biopsy good treatment we about but we at much address have to which mean answer biopsy to So advance. is the of field aware and we think the this very characteristic think the And of a plan we all will and plans, that the according one of baseline to that our I situation. in issues. the part it the if kind of situation, they thing trials, equipment things well do clinical it. want the are working we us well than will competitive send the are of I – think this recruit you this for are through for

So very for probably organize for we’re NASH as the are to for is, its unveiling we We study very very in extremely things to know-how NASH environment going and the and name one somebody of look going much to [indiscernible] was terms the aware well of same the if very do we’re thing going be enthusiastic. of us. well

want to you if enrollment. that problem – prevent to moment the of the at active being very are midways we in So

that. very So on working we are odd

Dae Gon

congrats Awesome. much progress. question taking for and Thanks very on the our

Sujal Shah

Thank you.

Operator

is question. question Our Partners. next with Please Yasmeen Rahimi your Capital Roth with with proceed

Yasmeen Rahimi

that so you X not about Question a on tailored program. ongoing. but your at Phase taking Two my questions. year, there much time studies question. for took many is was Intercept Thank PBC

Given you one studies out that the OCA that as Phase enrolling OCA to enrollment. still anticipate patients ensure on And I then here patients period that to a expedite on on do wash patients as to X actually on fact anticipated take including rapid it or are include enrollment have seeing question several in would have OCA PBC NASH. are well

Sujal Shah

I’ll Sure, that. Yes, answer the question. thanks for

as to a development point today, with Intercept when important Phase was of out Ocaliva. in X PBC You opposed forward very aspect moving in

more leaders, that thought of really in in real process heavily. here years. it experts This it there two commitment in disease So the expertise engaged plus field liaise the we’ve certainly with the the internally gained orphan is is internally mentioned, with competitive. here an as the investigators working been And very field, in PBC for we’re a Paul is knowledge now to and

study understand potential real suggests certainly generate it’s that for from more So We competitive. some patients. enrollment that and had X ongoing improve year of protocol, Phase we to to a we this extension from that patients of the began existing the investigators, really have in from eventually the January advantages these the related study seeing and patients. XX continue alternatives also that concept treatment from study safety X enrollment, data therapy, not and interest opportunity amount of in have they’re significant to to therapy continues they’ll treatment that patients initiated the fact think long-term uninterrupted. meaningful but as that mentioned important clearly proof to of We only after for The and that criteria Phase who have Phase X they the receive months benefiting really for the

disease the X to can. to disease enroll orphan All think think efficiently challenges, important our and commitment we rare improve where today the for good as important study. critically are population highlights as us, about patient of and all these really but to I the as in patient efficiently presented Obviously, to enroll and we sit relative continuing about care of enrollment very Phase is we feel as we things opportunity

Yasmeen Rahimi

Thank you.

Sujal Shah

patients had Yasmeen But around, who we'd Ocaliva. part whether the and of experience the allowed other question

Yasmeen Rahimi

correct. That's

Sujal Shah

Yes.

that's So right.

levels question to would period both of be parameters you've inappropriate relative think And course, I of highlighted have had criteria met have there enrollment think the that to part that washout be to period. – been washout other the patient that I treatment and in appropriately the that even for any prior. AP on Ocaliva

Yasmeen Rahimi

NASH. question And Great, more one then you. the thank on

with a their the So this of completely because I've such potentially and we some animal peer what model and compelling a absent part could in hepatocyte can data agent And seeing in therefore we seen could mechanistic effect. ballooning, lot there's therapeutic toughest half histology. And announced other time read insight, the your PPAR than why ballooning the provide most, probably trans most would any remarkable when humans. in would any have other us ability ever with really animal to with I hepatocyte PPARdelta have specifically you the be ability mean model we ahead,

Sujal Shah

Yes.

I then to think it. stress. take activation I which thought induction And very I is for Not caveat stress ER playing of would are say further a been comment that necessarily that confirm has my them feature I characterize would inflammasome, hypothesis. the But we thesis pro-inflammatory pathways attenuated. and to – it, are investigation insight example, that the strongly think you will that key just as NLRPX potentially of apoptosis to

is not exaggerating reduced free say cholesterol profoundly So we maybe almost pro-inflammatory. – cholesterol free without I level, we know extremely would strongly that

really known the As as of other that to ceramide well are drive agents stress. ER level palmitate

least lipotoxic ballooning. This form, such mouse, thinking which we the driven cholesterol. is in a asset that well the had free reason why the I So Lipotoxic. is has this to as strong is of or reduce delta at That the the the form feature in model, maybe strongly non-esterified really as of ability the that on necroinflammation strong effect

Yasmeen Rahimi

late year you Thank for year. for congratulations team EASL Great. a much selected breaker this so what being competitive and

we’re very you. for So excited

Sujal Shah

Yasmeen. you, Thank

Operator

with [Operator your proceed is Tenthoff question. next with Instructions] Please Ed question Jaffray. Piper Our with

Ed Tenthoff

very Great, you thank much.

dig you update my just bit on calls. But we answered, I’ve at juggling more a been Paris? expect guys. echo that I a little should me congratulations what into because is And if between year. Let apologize we the Thanks great I’m what EASL, in should expect

Sujal Shah

Yes.

question the for thanks Ted. So,

So key in key liver at at one meeting. to we’ll to of excited the a EASL obviously the third a have row for the presentation opportunity have year

of At able milligrams phosphatase well we really we provide following that parameters this have had as milligrams. be we of a after be As following X XX weeks rates update in range. data that with that the more given below read explored that of obviously the as we’ll as milligram alkaline a normal weeks in phosphatase well X X.X last milligram. was looking less you update another patients be the we’ve little and with And responder now of at considerably doses X data times, We and relative X.X patients do of the to XX PBC we initiated dosing times, that the response XX those response the experienced hypothesis about key asking weeks minimally is dose remind announced July, that’ll talked us know an alkaline of interim that of the to patient at we’ve a previously have X of XX, the parameter set. effective was reduction X pruritus. shared as impacts through each at either robustness the anticipation at but if we’ll of looking dosing both agencies discussed bit the The Pol as on EASL, to AASLD normal as dosing XX through just we’re dose. from upper a will patients limit and at another been And

And collect as an the is overall that continue to we’ll the March And so EASL well. published around abstract website. will give part update believe be we their presentation. XX, update data pruritus experience EASL an on I according safety on for at of to finally and pruritus just

in Congress. level that at that advance frame information So of least will be will time high available a the be the which at

Ed Tenthoff

really That’s look that data. too helpful. I’ll for Thanks.

Sujal Shah

we concluded over have question-and-answer Thank closing our Ted. Sujal remarks. for like Ladies I would turn you, to And Shah to the and call gentlemen, session.

Sujal Shah

the everyone in tremendous like us operator. again their call it you, support involved The of are without for and think Thank I the I’d on at the that has been course for thank commitment grateful the investigators for studies. to here work energy company today. here joining never And everyone by the goes all patients of saying you and we the greater. And thank our I and

XXXX. have you coming today, many As discussed we we with forward look Thank months to you. we’ve rest and sharing which in through the update the of

Operator

Ladies gentlemen, this our concludes and teleconference.

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

Cymabay Therapeutics (CBAY) 15 Mar 182017 Q4 Earnings call transcript