RETA - Earnings call transcript Q1 2019 | Reata Pharmaceuticals Inc

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Operator

Good day, ladies and gentlemen, and welcome to the Reata Pharmaceuticals First Quarter Financial Results and Update on Development Programs. All participants will be in a listen-only mode during the presentation. [Operator Instructions] An audio recording of the webcast will be available shortly after the call today on Reata’s website at reatapharma.com in the investor section.

Before the company proceeds with its remarks, please note the forward-looking statements disclosure on the company's press release. The company will be making forward-looking statements on today's call. that noted results filings. in factors expectations, differ many those including the are could to cause from There company's SEC statements of guarantees are Today’s future outcomes. not only made also may and replay be time today's Please or any the longer today, comments at any that call XX, note no speak of as accurate XXXX, transcript of May on webcast, reading.

would Vinny host we up Strategy. may for Vice Instructions] I Following for of call questions. your introduce conference, the the now will prepared Vinny, to open begin. Jindal, remarks, President today's like [Operator you

Vinny Jindal

Thanks Chief release can Medical Nova release development I’m our reatapharma.com. our Huff; today welcome call press section a Investors results, found Colin call these I'll the over Officer, with provide [ph]. website first Hello Warren. Reata discuss of press Meyer; Officer, and our review be programs. everyone. summary of CEO, of This to to at Good to our the and a to our and now turn by morning Financial morning, quarter Warren Chief Jason we the our results financial a Wilson. joined management’s on and issued

Warren Huff

call. you our significant Good pipeline. and Vinny. everyone, in our our to year made advancing over joining we’ve call development progress like thank morning, for us quarterly today Thanks, by the I’d begin for reviewing the last

arterial the lead CTD-PAH. NrfX catalyst The in in caused CARDINAL or and omaveloxolone of MOXie we’re we’re these results disease of MOXie this There results and for treatments are registrational have approved expect in The As of for currently associated first activators. tissue know, enrolment and positioned studies in report ataxia disease the therapies of patients. you no XXXX, if and our of currently deadly three topline we Friedreich’s study most syndrome. are of pulmonary connective the year. Chronic Bardoxolone Bardoxolone hypertension conducting study Alport completed In positive these by half FDA Kidney diseases either second approved the we of study for studies both to from both to CARDINAL

produced autosomal kidney Phase-X kidney, study rare polycystic X PHOENIX our focal IgA additional including type chronic disease, forms glomerulosclerosis nephropathy, Additionally, proof-of-concept CKD. data positive dominant of and diabetic and we recently in four segmental

On called the basis FALCON. the this of month a study of Bardoxolone data launching ADPKD, in registration we're

We significant were patients syndrome. eGFR These were kidney with to standard-of-care study, patients the Phase-X the studied benefit Alport or CARDINAL declining of results delay bardoxolone retained term Bardoxolone and from also eGFR in treatment, safely prior on program, therapy we the with long demonstrating retained improvement and actively following of other development filtration observed glomerulo in Bardoxolone weeks reported suggests failure of XX-weeks drug of term a prevent patients three with treatment improvements may entry that eGFR Alport a long in eGFR pursue in Starting rate portion estimated forms the and of PHOENIX. after plan that our we in our syndrome withdrawal. or CKD rare with four to that in significant the XXXX benefit experienced treated into

full after has placebo and the corrected of The a support years treatment significant initiated eGFR may statistically enrolled one with of eGFR support accelerated study. we fully the of a of provided two that may approval. results, the Phase-X On portion approval year guidance benefit treatment CARDINAL Phase-X basis and written FDA retained the retained benefit after us

We’ve combined, which line from year, first trial the the announced as well PHOENIX cohorts XXX quarter from data patients of we data portion a nephropathy, line IgA with of of In top top data FSGS in available be CARDINAL expect included of the total this year. summary Phase-X to the CKD FSGS XX. eGFR half by as each this Across baseline from cohort patients cohorts We second cohort all of all PHOENIX from enrolled ADPKD in the the from increased the XX% of XXX ml results meeting minute with week XX treated improvement X its PHOENIX, in four diabetes. reported for an by weeks positive XX, type mean per at eGFR. and at an increase or of X.X patients eGFR caused week primary endpoint demonstrated

one mediated entering PHOENIX, for decreased patients XX% ADPKD ml significant experienced the eGFR not in through urinary minute There effect Bardoxolone one studies and a were function all four no treated on year whose was change of an significantly evidence glomerular actively kidney year XX a three at providing Bardoxolone’s eGFR an washout. optimized mean of with weeks In the an improvements in and average standard-of-care. most least of with despite with and per at these increase increase change patients kidney benefit that retained observed In increase from duration, in of baseline. is one in there function versus treatment pressure. protein trials the X.X pressure strong XX-week was the in significant baseline of week cohort study correlated Bardoxolone Importantly, was eGFR change declining prior after in on patients year blood eGFR

improvements eGFR PKD may term translate CKD eGFR of XX-week the observed suggests these other result, in improvements with forms observed that patients the in to long a As patients.

investigators approximately States, fibrosis international The same the now patients In of and which XXX a by clinical placebo many improvements common, is and X in study and disease; controlled, distinct study study CKD for sites the the we January, enroll Australia. strongly observed patients mitochondrial light this forms randomized, thesis that FALCON, plans sites. in function pathway will impairment Bardoxolone addresses chronic that final of that Phase function. seven a our of this, footprint a is of in announced We kidney across leverage similar ongoing driven finding kidney inflammation, and double-blind of significant and Alport United to across in CARDINAL of our progression supports that will of have Europe, syndrome

guidance all in As are retained and anticipate syndrome, retained for corrected we The data half FDA We could submission for placebo two one studies for in provided from first one second CARDINAL placebo data in will trial the eGFR the syndrome this year pharmacology year approval and has that preparation FALCON year has written could data FDA we Alport clinical data the NDA conducted toxicology patient accelerated support eGFR commercial indicated the and studies enrolling and that Since approval month. active support patients ADPKD. event required FALCON the the corrected launch line CARDINAL Alport full positive. the the this study top have and in Phase-X submission. of are trial year, in in preclinical NDA that later we've

We and commercial for significant in awareness sales our initiated chain We are making Alport in campaigns investments operations place, we've and first our marketing syndrome. supply readiness. leadership and put disease

results week Friedreich’s or our now improvement dose, mFARS the a Turning we're scores baseline FA. Part XX, to significance scores the first P placebo study ranging in line approved therapy we mFARS available at observed to be our neuromuscular for pivotal the Based this and second treatment on trial modified of dose value the in NrfX omaveloxolone the in ongoing of In the fully significant second program, of study MOXIe and generation of pivotal part the at improvement rating for patients that The omaveloxolone, scores disease a expect X, design we corrected Ataxia of optimal scale of optimistic is the statistically potential MOXIe, data versus the of X.X X MOXIe, Friedreich’s MOXIe one studying this activator Ataxia or half we from has top to Part with which with FA. the enrolled become approach year. and in are

PAH, and the for catalyst with pivotal in with with CATALYST fourth design bardoxolone of X year Based In the study with therapy the trial, the has only form specifically CTD-PAH. CTD-PAH. survival prognosis observed the comparison these become a patients Our first the CTD-PAH have bardoxolone of patients with we optimistic therapies of XX%. and rate to is results phase patients dilator LARIAT [ph] approximately have that idiopathic five our despite trials, of approved potential on are worse the in patients generally treatment trial patients Baso a to

We call over be the now line available quarter. Jason to to data XXXX. of expect in provide summary turn top I'll the of a first for to half the financials our

Jason Wilson

development Higher expenses both for Warren. And net expenses million noted an primarily XXXX. net clinical year. for driven for loss to $X.XX total Thanks million same $XX.X in income the as million was financial million. ended and the of by compares manufacturing to an of expand company activities. $XX.X.million R&D activities The $XX.X expenses increase for research in for accounted incurred an with and development for year development share, morning $X.X quarter the per increase the driven we period research in reported the increase of accounting This XXXX personal quarter compared we March for for $XX.X or last expenses results or and million decrease per our revenue. as first and loss $X.XX quarter Net period is XX, expenses a to $XX.X period by The due in the total of earlier, the expenses same and three of months were prior this share when

to from related contract end of and know, recorded a a through revenue of execution As guidance agreements primarily in to in milestone number This milestone first a period license to a therefore of due to XXXX. due in ago. entered KHK. has that XXXX. the uptick of in performance XXXX of partial been was the did collaboration quarter-over-quarter recognition now first the period not in revenue primarily from across revenue years the the recognition contract of portion $XX was the milestones time you is allocated revenue the obligation quarter from million to occur quarter But The to related into the decrease full in revenue large likely XXXX, and of date sharp change

to measure were XXXX found the reconciliation the March compensation based A total million XXXX. $XX.X period attached $XX.X Our stock ended for same depreciation of be release we cash million operating this expenses for press excluding based months as this and a XX, filed morning. total measure expense to ended expense the in expenses, to non-GAAP non-GAAP define can three expenses, compared

With We advance product administrative to future candidates trials, clinical and our expect and expenses cash research validation March continue we expect which and ongoing equivalents, both and candidate development our and that, of readouts registration for had purposes, I'll million $XXX.X product over manufacturing through will cash to our increase for plan future increase product cash call in XXXX scale trials. through for the as to XX, registrational we data Warren. At the portfolio, our back turn and commercialization personnel, based three candidates. operating ongoing fund clinical our our we in expand operations

Warren Huff

programs pipeline advancing our of for for syndrome, and that Reata, mission registrational of improvements meaningful four of in approach therapies. At clinical promising molecules. with mechanisms pivotal along Jason. therapeutics ADPKD, We for current with produced novel effective into a opportunities bar high looking phase studies X studies. expansion severe series Phase Alport X is with to develop we CTD-PAH studies This no Thanks, and of orphan for has our additional a proof-of-concept battery set Friedreich's in a ataxia key provide parameters, diseases programs conduct action

our milestones pivotal Reata the including XX expect achieve later data major CTD FALCON in strong to an positioned Over trial from studies reporting the from year, to pivotal the XXXX. I'll of the pivotal in soon to for ongoing We in underserved the groundbreaking now first orphan commercialize in in one portfolio forward top activities, month, turn prepared course in progress. and line line our ataxia months, second over you the questions. operator next launch years. call half therapies our initiating is for of ADPKD -PAH or enrollment we or preparation With look remarks, our pivotal this coming of this top updating syndrome data Friedreich's the registrational sheet, trial our and reporting concludes see That and in more a Alport to of a half diseases balance commercial well programs,

Operator

first Instructions] Yigal comes from [Operator Citigroup. question Nochomovitz from Our

Yigal Nochomovitz

bit earlier you a three of spend conveying it talk Yes, I to hi to meeting that you. question. and appreciated nephrologists your giving week appreciate and both at worth from you feedback little message us the that community? you CKD clinically what data needs perhaps specifically of talk more Colin, good the wondering you if could that the I’m for highlighting to or think morning. Thank nephrologists. better pre-clinically were understand after Thank we're were gave points the time the just a taking this some

Colin Meyer

Yigal. Sure

numerous by I development working to that was meeting of role. the remodeling of the in CKD CKD key the companies were Global So is function that the of fibrosis, think, the and plays function well KOLs of in talks inflammation heads interest what's community loss global is drives There mitochondrial the demonstrating role attended for and probably quite space. inflammation evident. actually a kidney becoming and And

And so there about probably mine five before were this. talks

how And I for reduced wasn't broad can utility. so, when suppress spoke role X it of inflammation had it mitochondrial very and surprising, the fibrosis about function, [Indiscernible] and

those I think had pre-clinically interest think aspects following were us. of to not are who been main I there two that

This inflammation many is therapies. very pressure, which CKD. pressure. or in that on affects constricted affects forms There the and glomerular that is acutely many an clear it's by hyperfiltration bad by many our do is volume kidney not drugs of pressure And of an which addressed in because of One effect increase is is forms mechanism is the and many available which are in function. present drug drug affect now increases that our of the course

showing think them actually and it so of no And that drug pressure protects I it was of pressure, the affects and the just and evidence volume, data affect does interest. presenting our there's

CKD the presented activity our different literature, other preclinicaly was many that on we the interesting of drug and and preclinical basically now was think where data actually I in of broad element reduces data six data examples to different and forms forms this there's fibrosis have I there's so the additional that CKD. across

inflammation a with to Matthias actually presented forms I group was of included disregulated were different mine. a IgA pathways a nephropathy group big his that and and study across runs demonstrated think those were talks University few different clinically, people that by nine hypertensive eGFR. loss Michigan including biopsy the of of CKD, interest nine Alport with large at across syndrome, what those He FSGS and CKD was of diabetic CKD, pathways metabolic associated data forms before Kretzler,

So and endpoint and it's use clinically, across as was well appreciated hub well years. different forms obviously drug that function about value to even that point patients as the trial physicians of that associated that Many biomarkers. the to events ago. interest endpoints most of of actually our And was lab a newly was connects many interact BEACON clinical so validated CKD. them, people central not striking that is end-to-end though in five The for published there's the track been effect what We've that CKD. seen think that our had think is was the new notably, durable from for kidney with reduce lot to up our I years I active data. people data then showing to It's two inflammatory and reduction published

and share three now. And aware CARDINAL syndrome so-called specifically previously that's far trial most we're ongoing And significant NKF, trials deputy trial Foundation Kidney a that approval. of estimated group, National benefit increase the the this and from actually quite efficient in director is group Alport who Thompson, FALCON other from these give endpoints Willis have about ADPKD routine in who think we've FDA demonstrated obviously Kerry the more there. spoke people working FDA to weren't we we've about Dr. a participated working endpoints much our endpoint now that launching that few led I a so companies Aliza us new path conducted. EMA and that she And FDA withdrawal the ours, for in and and after joint that

and pretty all-in-all, a had I And lot positive of presentation, so it think was compelling feedback. I

Yigal Nochomovitz

great. Okay, Thank you.

translation part can data. Just one translate? the that data will level Obviously you've very that the you Alport, how suggest XX-week is just that, up that XX-week nicely the modified XX-week regarding shown XX-week FARS data, from you bardoxolone would you. that see but quick believe with the X Thank evidence translation omaveloxolone the for of follow and how MOXIe that -- that you you've for to the what data, I shown for wondered the

Colin Meyer

into trial seen So XX X BEACON XX. syndrome phase week we've in and eGFR We've also it obviously seen our BEAM from Alport to translation week trials.

seen suppresses really restores and the NF-κB different, setting duration haven't been is activity molecule where still the we a function. clinically mitochondrial has So longer same, with NrfX The obviously pharmacology induces slightly but lost [ph] treatment. is

Yigal Nochomovitz

you. Thank Great.

Operator

Our line next the Walsh question of from from Adam comes Stifel.

Adam Walsh

morning, my questions. Thanks Good guys. for taking

on of Colin, action point action. on mechanism physicians curious, So of of degree there's just debate a street mechanism up I'm the follow obviously at specifically and from the about around Yigal’s this some question. been feedback first acceptance the the

or I then of of Thank feedback, for lot work think, data check the to how just some community from in there that? prove or clinicians ongoing microscopy studies So, box at clinical out of correctly the some see so, kind recall at that laser I me, And that us the around action. accepting you. prove you I tell meeting? further, your the you think to this point mechanism Is are may mechanism studies can also, you're then when broadly trial? and If have a still debate going

Colin Meyer

Sure.

of think only debate who I people there's -- So, our are in of unaware data. our

willing the was defined investigators speaking know think think any so the in drug debate no there's result filtration in questions. you And I evidence and in interactions hyper many CKD at everyone And I of in cause pressure, through we've I increase specifically I mentioned that function of that you preclinical we've evidence. had listen before, an or think of part major filtration. the an KOLs adequately in increase our data of all And as with would actually the was even are kidney does all what or who to either clinical addressed to know and as lines there's conference. and that think to I Hyper

that There's glomerular through And I clear there's there's unaware and blood [Indiscernible] arterial I [ph] by that. do there's that effect does not so this no doesn't to actually many drug relative way that hyper way only parameter no walk ways evidence which [ph] are And there's which and non-nephrologist transmitting quite drug to only drug The of do is do caused, the published when effect to top International, volume be that. pressure XXXX is think specific systemic the [Indiscernible] our I the other the simply the journals. it's preclinically that not does that does in data, we this And have people surface the it’s drug cause kidney it. Kidney called increasing and area was mechanisms, includes the AFL other two kidney affect filtration. the then that. of And can dilation and actually evidence, and or to eGFR think in one

question a unwilling I it with I'm pretty described are data published coupled the the several compelling who models that the listen bardoxolone filtration, think that our those ones of only function or that are data. aware And models still actually that really and now all that fibrosis. that people question and there's to really of nephrologists aware reduce and almost several preserve provide answering hyper picture, and to once kidney models to I fact across in published when clinical [ph] papers So few Yigal’s data protect, omaveloxolone data a there's

probes once I what the is as that again preclinical last think artificial you really remaining of measured. much living there's debate is that many is CKD kidney laser directly And any any informed were picture the allow And far work and different. I we the techniques can microscopy And at to think sophisticated, what the mentioned, without those discussed set of the meeting have yes, these imaging questions address into really so, animals X that and very them. to I picture one clinical manipulation, and about not be visualize experiments physiological as parameters that mechanism, sticking investigators in

think, that medical be that will meeting. at be hopefully definitive we quite and we will And to work that so, a future presented hope

Adam Walsh

know back Hey, going granularity may kind whether more you do thanks. any quarter of That's timing any more beyond Thanks. half MOXIe study the it's the great. on And which have and come the be results or and CARDINAL and to here, indication the first year, of just third fourth this one quarter? you

Colin Meyer

enrolled line we don't. but say top really No, expect more we and can't second than we half that. We've that, really to guided both in fully are the studies data have and that

Adam Walsh

Thank you. Fair enough.

Operator

question of comes Swartz the of from next SVP Leerink. Our Joseph line

Joseph Schwartz

Great. Thanks very much.

number So there some that with of bias new some upside suggest to kidney that out are diseases. patients there be studies the could rare

about patients community can could to protocols how So on I you be little of CKD? you to benefit find the treatment different diagnostic the in and forms was wondering who if expect the a talk are do where bit most able [ph] for evolving Botox from

Colin Meyer

Sure.

with of kidney few the function past ask think Alport the would And hearing that and most are and loss, that if they years actually with and blood boys been syndrome, in the also affected. to them them speak those so ask urine young typically it's a the you appreciated comment it only patient, mothers and I has in boy, you average impairment to nephrologists describe about

are population. Community And and minutes a to Alport It's boys. that reaching has about mentioned many maybe of Syndrome risk suggested so, the patients. of It meaningful Syndrome including journal stage also syndrome Syndrome membrane so the I International XX,XXX new, of And of other communities May hereditary is syndrome a Fairly a between there of published patients two together our It primarily U.S. comprises excellent global very few autosomal those recommended the Alport last Those recently it has meaningful as lifetimes. comprise for experts thin the disease. a few patterns similar in was which Alport published have dominant ago, is in known the diagnosis in mothers basement that a guidelines come in that of end XX,XXX the a International Alport also patients Foundation XX% phenotypes. Kidney set Alport appears year. previously same to

so now many And One we're and now, Alport the educate to community the about of them are telltale syndrome. sign in phenotype obviously been better who forms working of efforts is on the the identified, nephrology right have classic patients are many right blood urine. broad

And the types that cause urine. of in so, conditions not kidney many blood can the

the There Alport related And not, plus CKD. of trained they patients patients. the Society it. telltale have dots, so years young the ago the treatment sign have [ph] were and CKD, urine, sometimes weren't people identify don't member well who boys of forms, patients nephrologists the family had as about because it American that to Journal as published hard for the a are XX of in of Nephrology, the It's a they're identified took ago other is group was hearing CKD, the loss and is but none they years a blood four there and truthfully now in XX, member hematuria in syndrome was those study if the XX% XXX and family known

that provides I identify us mentioned urine. the actually road in map because many blood conditions patients, caused clear not And for these to so a

Joseph Schwartz

the patients able campaigns and of your then to at drug talk been the many that question. into you juncture individual leading And, I able you patients Okay. identify have you awareness know, disease receive market you Interesting, approved. and kind reach can't Alport. how about next until this ultimately to and so can materials it's after But in approved, drug, far? are could are my

Warren Huff

point. haven't we specific So identify we haven't patients initiated this campaign -- at that to

and community We many of educate Colin the at already transplant But have risk classic simply with classic a this boys particular, mothers yes, the about dialysis in That being are that campaign begun lifetimes. high phenotype. the needing mentioned. during findings to a awareness is or of their know has also phenotype a you the disease of the there that data

Joseph Schwartz

my for Thanks taking questions. Interesting. Okay.

Operator

from of Maury from Raycroft comes question line next Jefferies. Our the

Maury Raycroft

Hi, everyone. Good morning.

question the Alport. just First on is for submission FDA

file Alport results? so on prepared based topline it do Just I you provided positive, the already, assume syndrome you're are can your remarks, the writing think quickly how report you data you up after

Colin Meyer

actively support so are month Friedreich’s for we approval for well they we’re Maury, to that expeditiously interact going able had quickly have NDA. more that many regulators. positive provide to and we with long yes, timing positive, not regulators have once point, we're that the to to we're the interactions guidance process, the and syndrome assuming and At filed those this hopefully and to ataxia Alport working provide as so data want guidance make we'll on sure initial with as data and the on NDAs and

Warren Huff

But add I'll of aware very of no with that deadly that, a groups therapy. both these we're disease have approved just patients

doing can everything be we'll So programs move to we the expeditiously.

Maury Raycroft

those has you studies. trials, on X Alport Got much dose if [Indiscernible]? in in occurred has can it, of into remind wondering for if CARDINAL have syndrome. I’m any impact those the okay. And if PHOENIX reduction you X reduction just was reducing allowed then for phase both X and Phase for how phase perspective And the dose

Colin Meyer

specific the but Phase max XX% of of doses, dose. So the the context typically the thirds as as we in comment I on trials pivotal can see data, X two far patients can't or tolerate ongoing their that

And so high. this helps titration compliance the sometimes is too definitely scheme dose goal but

compliance. And clear may with they dose. reason in have be conducted, in this be that not some or the that across When we've it's obviously higher smaller trials pivotal for helps at the prior trials may we patients size so, a that often given exposure we look would that hope our

dose difference so in dose end And of response. there does not range, the appear at be a the higher to

Maury Raycroft

if and warehoused the wondering enrollment. if Phase Okay, how Phase into just ADPKD so just last the into those over of great. and to from linked some many X? the go And I'm question X Phase are on the is patients can you of roll X patients

Colin Meyer

weeks, from with we So patients who've participate to those sites only no we patients that only in XX in but data not the exposed been to PKD. and do allow our eight U.S. eight drugs patients, enrolled future in was trials, in

many investigators is a have there's enrollment. enthusiasm these much rare to we’ll Obviously, approved U.S. a competitive We're of only for XX of enrollment standard haven't targeting provided there about large globally. specific so the on But first and in diagnosed in relatively but of the We amount to the allows the this sites is are not quick yet care. that's of already disease drug our approximately hoping patients a and a enroll and set patients large we U.S. larger PKD single trial. patients agent since and a be is XXX,XXX

Maury Raycroft

it. Got

you very for much Thank my question. Okay. taking

Operator

question next Our Ladenburg. from Kaplan Matt from comes

Unidentified Analyst

Thank for question. the I a Maria Matt. for you have This of questions. is couple taking

The they the out program, And different But year its now Catalyst it's for… probably program, a almost XXXX for is away. are – speak to one CKD I would salesforce team about that and was rolled that half for first if wondering a still that commercialization. you [Indiscernible] in and early you first need

Colin Meyer

Yes.

Friedreich's actually other the sales for So from for connective well two force tissue the pulmonary yes addressing. pulmonary the have We disease dedicated arterial obviously drug applications and PAH of physician we Alport expecting separate is would as for other for different forces the the ataxia sales dedicated the a and [ph] forms that diseases force were as very associated, target specifically we're syndrome that group CKD. we would for of rare the anticipate separate

Unidentified Analyst

CKD pivotal to the of other trial And you moving regarding your Okay, pursue studies, forward intention then form rare besides ADPKD PHOENIX commercially. announced to great. and the

for by which Type high include there percentage. from you very XXX that patients think patients of diabetes showed why XX% obviously study? were run was or study and in a for in also, this patient you enrolled patients a who a XX% baseline there Thanks. eGFR, of results, – or common or an their So PHOENIX X Japanese not you in CKD said is improvement theme will the would they population reason did But the an common partner in respond? didn't the caused I And show a improvement,

Colin Meyer

maybe starting last your question. So with

drugs most and we comparable patients. remarkable we the have So have Yes how increase which don't PHOENIX is showed in in an XXX eGFR think efficacy. XX% striking

of well are majority there exposure there noted of of to eGFR happened the with others, increase. why didn't know. diabetics they normal. just very particular who as the eGFR there or change for if were showed subset lack XX, know don't CKD and that it's And and there's to few as reason those As so have far cohort, an is patients some is We and low, generally be patients, XX% some And unable is no about X as, respond. is response. enrolled a if so accounts that type the really near in they to hard who We

Japanese our CKD. Japan KHK partner, conducting X both correct, is You're Type and a diabetic X in of trial Type

we be bardoxolone that have we and active I we seven point said, excited actively what We broadly this is about at thoughtful as of Warren CKD. are to think, shown in obviously next. do distinct has forms

can rare we to CKD, are we make sure so would the trials. for then forms additional now FALCON that on later we'd similar launching approach. so additional that these available And And resources We're trials, programs. of and likely pivotal this anticipate we when month, three are be executing execute all a our need trial

as very design Alport trial for And similar our syndrome. for FALCON so is you heard, have the

so And the we time the just opportunities. is make We appropriate process the resources to additional sure this that need allocate right at scalable. for

Unidentified Analyst

you for taking questions. the thank Okay,

Operator

comes next from Brian line the Our question from Instructions] Skorney of [Operator Baird

Brian Skorney

good guys. for question. Hey, morning taking the Thanks

decision, timeframe you price? for FALCON you in would price we similar seem for and like getting at up looking data have can it upright, initial match two think wondering of look here, you populations, can your top it polycystic at it there timelines get kidney Just how do does patient to just does all different a price when or affect at extrapolated to do kind bardoxolone. determine the when Thanks. pricing be line that Alports price to an I'm you expect the think four you approval looks set for be that and might all disease or

Colin Meyer

as approval about we probably the how PKD. enrollment and guidance as specific and close timing, of that or syndrome so far time, So NDA approach to haven't have for submission, obviously we the be for potential timelines community. But obviously it's for we period reasonably thoughtful obviously Alport nephrology for provided within

would independent, relevant As prices are we far syndrome. as we probably think figure they pricing, what out Alport for

Jason Wilson

to you the obviously provide in the the or informed both transplant. And are lost both be the by to half of the these patients that to function of the and the actively is each just years. to that designed designed know trials. for Yes, going studies dialysis pricing have drugs reduce of as you could results have of course I'd clinical say just I'd are Most whether disease kidney -- entering know about cases, studies treat been risk information patients I modifying on are that the these is prior their think declining studies. a go

And progressing hoping kidney significantly demonstrate data to to have, hoping the so end that stage drugs reducing risk disease. we're will of that we're can the their

will priced be obviously are. so on And drug those results what based the

Brian Skorney

Great. Thanks.

Operator

our session Ladies you. for answer question Thank gentlemen, and conclude this does and today.

this the Website available after the you have As a Reata’s wonderful Thank call a and reminder, an today's audio may will for on at concludes in call, This recording section. day. Everyone disconnect. reatapharma.com be conference conference. participating all Investor of shortly you your in

Reata Pharmaceuticals (RETA) 9 May 192019 Q1 Earnings call transcript