RETA - Earnings call transcript Q1 2022 | Reata Pharmaceuticals Inc

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Operator

Thank you for standing by and welcome to Reata Pharmaceuticals First Quarter 2022 Financial Results and Update on Development Programs Conference Call. An audio recording of today's webcast will be available shortly after the call in the Investors section of Reata's website at reatapharma.com.

Before the company proceeds with its remarks, please note that forward-looking statements disclosure in the company's press release. There are many factors that could cause results to differ from expectations, including those noted in the company’s SEC filings. On today's conference call non-GAAP financial measures will be used to help investors understand the business performance. website. are release comparable which and be on measures in financial again financial found earnings Reata's presentation Reata's non-GAAP reconciled GAAP with measures can These from today, outcomes. Today's statements guarantees are of not future note webcast as today, longer replay reading. only be or also call may the at XXXX, of that on transcript May made Please today's comments time apply accurate and XX, no any of any

the to call you Following question up questions. the will prepared so that yourself remarks, We accommodate questions follow-up please one open limit can as one we and ask we as for that many possible.

joined Officer. Meyer, Reata’s Chief Chief At would like this are Dawn the Chief Executive Colin and by Officer; and President; Khan, time, over Seemi I Soni, We Huff. Warren turn to Warren Innovation Medical to today Commercial Officer; call Chief Huff, officer; Manmeet Bir;

Warren Huff

joining thank update. everyone. We I'll Good on you Slide start quarterly morning today X. for for our us

small developing or As of FA. you ataxia, months. the we're significant the know, We've Friedreich's NrfX program all omav, made omaveloxolone, last progress molecule of with few the for with activator treatment patients over a or

quarter was the Following study, we with meeting the This NDA. Part completion the XXXX. a MOXIe determine by and of of FDA third of to path division X pre-NDA to with drug results whether interactions multiple positive application, or submission had from in there review a new the our was the highlighted

with year. initiated for our rolling of this for for of in unmet to NDA, disease. serious the patients program, first Following address for quarter completed applied potential options the provided submission which Track were this Designation devastating for Track meeting, of we Omav with treatment we us Fast need the Fast and eligibility and highlighting the granted Designation the

recently Additionally, omav. granted designation to disease rare FDA pediatric the

granted, this patients priority on this the reviews plan date, If Fee year. could quarter in severity action User PDUFA Our to our request a Prescription the if next disease treatments of approved Omav for working a of NDA in be the patients with lack Drug We're the first the based we FA, includes the in with this Act approves the review or FA. for NDA for and date, position year. while FDA it fourth launch with And to of treatment drug year. FDA early of result our

plan committee continuing We've in filing we're the to application an complete procedures and that required for authorization on a the fourth to the submissions are secured plan Finally, Europe. XXXX. regulatory as to quarter to in we pediatric Omav a with marketing the Medicines pediatric investigation submit agreement of in our Agency condition European MAA

Next slide.

priority ongoing our are we our have the a ensure our in clear on on rare regulatory been division to Regarding FALCON forms so aligned programs has the we with completed in division. and design protocol a the meeting issues a that discuss of submitted raised recently FALCON. FDA to the we're with Alport on to the proposed our NDA Syndrome, for Type forward X important Based Phase to program. during the our that CKD, for work the review that for trial amendment design ensure trial trial, first aligned amendment We've protocol of path that we A to

be slope eGFR which meeting, provided a over claim guidance with in the week discontinuation kidney it and eGFR from slows time is change the treatment that data would ADPKD function was support analysis the drug reasonable acute bard's that effect address at on our division patients also available The in at important weeks of addition that resolved. to baseline During effect endpoint, to should the division of eGFR exploratory planned question. the stated the that suggests endpoint pharmacodynamic that primary XXX, after to the proposed be largely stated bard it because will eight that accrues loss on XXX, week primary an demonstrate

that FDA additional FALCON, Importantly, be will They With emphasized alignment the confirmed do statistically results stated the our of and support important, amendment that FALCON to registration Khan ADPKD the and we'll syndrome steps on later be our next that with ADPKD. is about information significant. not Bard Alport call. protocol continue program. agency provide A of our to the it but program need to for also also our meeting the after trial and if on completion work Type will analysis the the could Seemi positive, confirm

that patients with on an the of fact last FA Finally, kidney trial of Omav and our time I'd RTA updates that and clinical with with The large than I'd now program turn on decline progress patients Dawn kidney then If discuss XXX. in will provide this to disease. in Japan, onset complete the to to CKD endpoint Bir year. Colin bard do patients the program the progression to our primary remind enrolled over to could in in patients results kidney treated delay observed in our diabetic it preparation patients Seemi for failure. commercial positive, trial X,XXX AYAME this III to over Khan, to who trial sponsoring clinical with Kyowa further in is Kirin, in to AYAME Kyowa ADPKD a provide Stage and our the then omav. study you who with end-stage program our of greater provide is Phase visit activities with are with disease. in the eGFR update second like With X in like Meyer, or in eGFR expects IV Kirin call or evidence half that, improvements our equal XX% collaborator strategic diabetic trial, bard

financial Soni Manmeet our quarter. results for Lastly, review will the

Colin Meyer

is is of NrfX. caused Thank by epigenetic neurodegeneration. associated It FA and disorder. Slide progressive lead X, you, to impairs Warren. which suppression Starting effects frataxin, and production neuromuscular a and silencing with relentlessly with impaired These energy of mitochondrial function is debilitating

and As for FA the the treatments. MOXIe, and developing dependent to altogether. inherited the in no with attempts Despite X,XXX FA is has disease ultimately with these there for been then diagnosed. their mid-thirties. and approximately ataxia, numerous prior in survival they currently wheelchairs, to adults children successful form approved lose FA walkers affects is an independence and X,XXX are patients therapies of median progresses, patients recessive none which become The approximately U.S. patients on

and slide, to due are conduct two factors. challenging clinical Next trials to FA major

FA participate to there a willing who of able in and patients, are First, limited are trials. number clinical

only there who that to significant a functional U.S. the trials in patients, X,XXX time At a have a endpoint study. natural effect one we all number are Currently diagnosed to MOXIe. study. Part available are patients support small research to enrolled for relatively MOXIe trial who the X, clinical volunteered FA As participating the a at design of future There I natural U.S. date history on approval. in participating demonstrate the are approximately could specialty X,XXX are just are in largest similar centers, completed is approximately seven with of the interventional the and of patients mentioned, and MOXIe for history only trials patients

the X about we and enrolled trial. sixth and Part available Part of them screened one most patients X, MOXIe into For of

are progression X, Moving second the trials in reason rate to FA. due slow challenging FA that clinical of is the to Slide

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no safety the Importantly, new in been signals extension MOXIe have trial. identified

slide. Next

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are assessments, which mFARS’ an missing. in-office some visit So required

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Seemi Khan

Thank you, update provide XXX development an on starting on and slide. will CKD next Colin. our progress I on programs RTA the

leading the of genes all cysts men the affects is of to and dominant We estimated the U.S. and ethnic of patients in both by an in or two leading formation ADPKD groups, safety with X kidney inheritable other the PKD failure polycystic our the hereditary XXX,XXX progressive PKD and trial. cause is and and diagnosed rare are kidney genetic ADPKD multicenter, randomized of racial a of in international autosomal form patients population disease, the CKD of evaluating Phase and organs. and efficacy blind one kidney control double defect with ADPKD bardoxolone in caused a fluid filled FALCON, placebo in women

the protocol. in our with meeting made on met during a discussion Type recently the A with Based FDA agreement is and we development the the FDA to program protocol earlier, ADPKD amendment. the key the mentioned an overall meeting, to proposed discuss changes Warren As

XXX, could after also week primary As on patients suggests by to pediatric is endpoint meeting is planned resolved at baseline of XX from trial. registration division than support the if to that the that age acute EGFR positive, currently plan since pharmacodynamics is effects minutes, from enroll be confirmed of to of trial should that XXX time. treatment preliminary that plan More agreed that eight week are bardoxolone patients which based of patients reasonable, weeks we with in the XXX stated it XXX with available the the discontinuation XX are the our years, The bardoxolone largely eGFR ADPKD. division FDA the patients enrolled change on proposed drug per data FALCON comments, pleased the in

RTA daily DPNP. molecular Moving another HSPXX. XXX effects or activity a in dose molecular to models, administered and peripheral and sensitivity selective facilitates of nerve demonstrated highly thermal that to existing survival models terminal I chaperone of modulator many Slide function. is mechanical our a nerve that program diabetic rodent XXX RTA small XXX in mitochondrial improved multiple RTA cell has neuropathic affects molecule increases response In transcription of preclinical stress HSPXX rescued pain stability are conductance in observed and diabetic mitochondrial function. and XX. folding will RTA XXX and of potent that C dependent, RTA neuropathy. the proteins. dependent. promotes function, is chaperone HSPXX orally and and restore XXX discuss HSPXX These velocity we once reversible

an to that, X pain on safety now the activities. placebo Phase the would update fourth of first trial completed we to we Phase evaluate pharmacokinetic or commercial like turn I initiated were study. demonstrated these studies, profile of with in Phase healthy efficacy including of interaction In in quarter double study peripheral pharmacology completion control preparation have to that safety drug-drug XXXX. of the adverse additional There no Phase a RTA With Dawn study a RTA to was discontinuation acceptable XXX plan in the profile with diabetic to XXX call our signals. an that blind of X We events patients neuropathic volunteers favorable. randomized with studies, The clinical provide RTA and XXXX, in Fall in drug over quarter X XXX. serious initiate no safety a X

Dawn Bir

attention morning, is team's Good everyone. focused you, Seemi. readiness. continue commercial on launch Thank on full The I'll Slide Omav XX.

patients market, treating potential of for market therapy for also the priority we their preparation is know development key launch. are and and intimately the launch placed a HCP our is the Friedreich's education. QX, completed understanding first first prepare and is We've treating In we adoption Our and drivers today, diagnostic underway. mindset, Reata's ataxia physicians locating market, knowing landscape community, also current to them the the assessment as landscape our desires through to important responsibility journey patient disease strategy of on

XX, dialogue Our in patient commercial educational hired severity drive operations importance two years disease materials including March our connect educate about patient a need payers team. engagement as in ataxia of efforts the underscore initiated and web-based step of FA, social ago HCP community. FA process. measure goal support to platforms disease link leadership diagnosis campaign. treatment. Continuing and Slide resources, and over about disease We've of with QX, finalized to advancing through launched mFARS The this on Payer tools, FACT Friedreich’s of and for HCP that In the progression. our regulatory the we patient is diagnostic the of was launch to severity earlier education the HCPs to is the

Our patient continues materials the trade development and QX, messaging specialty including work partners our and in is branded services. pharmacy design model limited and selected network and complete underway plan. and of launch a is front Much including tactical access distribution launch end

team poised Manmeet. call is launch. process our and to now sizing a launch Salesforce alignments successful ensures for the finalized. conditional received approval The over internal readiness cross launch. preparation will name alignment for turn and brand and be department I'll Our territory

Manmeet Soni

morning, good Dawn, and Thank everyone. you,

with start cash our on me XX. Let balance Slide

we maintained As a solid approximately of and cash million $XXX sheet March balance with equivalents. cash XX, in

our With ability will focus balance call. will our enable cash cash through the strategic strong of in balance, to later which priorities, Warren the us have cover the operations Our to our fund on XXXX. efforts we end key

Moving expenses. to

steps operating taken have We to expenses. control our

the a to the and This commercial non-GAAP presenting the XXXX G&A spending million in United were in for European to fourth all of $XX the related region. primarily Alport Our for of compared of to quarter significant reduction as quarter expenses reduction $XX.X XX%. launch XXXX. G&A related million expenses the States of is first cause for preparation syndrome activities the We're

the of anticipated and call, the launch As of on focus restructuring commercials commercial the for the adjust size our XXXX XXXX. Omav sales preparation for we on adjusted mentioned a we did the delay launch and early team XX earnings in January, the February bard team in appropriately in early to to

expenses and for certain $XX.X first the to fourth as manufacturing the primarily XXXX, This the in were XXXX X% representing to million million related compared related quarter R&D a reduction expenses of $XX.X to non-GAAP compared timing quarter quarter of the of for Our R&D expenses. of reduction R&D is last approximately. as activities

approximately. Our non-GAAP $XX.X for operating XX% million reduction expenses the as a $XX.X of for of the representing to first million of compared quarter XXXX quarter were fourth XXXX,

filing for call in have the of for On year. the will MAA actively and launch that, FA Europe. With I we the the anticipated commercial FA front, sight we building in commercial team anticipated European early Warren. in next operations to are on working With launch our also for commercial infrastructure drug supply initiated over Omav for preparation the back turn

Warren Huff

program, good In closing, be be next in preparations year. commercial this our FDA And severe this the the our a in of for you, to filing including preparation available Omav to position early launch and the NDA we're working progress approved, our made Thank first MAA on submission If Manmeet. later it Omav we've year. actively drug disease. will anticipated for to

the Manmeet for XXXX. sheet, remainder priorities our As balance be key of four we'll on with strong focusing mentioned

of review is working FDA FA. the number the NDA our and for working for Omav Omav with our patients the Of on towards with priority one course, of of treatment securing approval

pediatric priority agency agreement investigation MAA the our secure of last Secondly, European during made the with the on is months to XXXX. progress quarter an Omav for our to in the to submit few fourth second plan, medicines

DPNP continue with fourth FDA, finally, A the to Alport And syndrome with prepared for is dialed following of X continue a to and and initiate who meeting enrollment for priority the our operator the with thank work That we'd Phase the is I'll now our XXX find patients during of a the to turn in our XXXX. Thirdly, to to the path like everyone for in study the forward Falcon study over Type fourth the remarks, concludes program. the quarter completion call focus questions. with FDA RTA to

Operator

comes Instructions] go Citigroup. Thank ahead. you. Yigal, please question first today Yigal Our from from Nochomovitz [Operator

Your line open. is now

Yigal Nochomovitz

Hi, been lately Colin, start could Colin, appreciated so I'm the that on Omav. Manmeet much again Warren start are because on taking analysis. into getting team. analysis digging question. this as delayed Thank if and for I've delayed and people a wondering comments revisit you the you questions just of the and lot I

So I Omav. the Omav what two switched on exactly to effect in up the which bump-up looks placebo, and in Part good. the a switched me it mFARS from for trial very, it to very which a emerging see for in And makes drug so happening convergence plateau sense perfect Omav the to the the is, placebo then of patients showed placebo saw effect patients obviously, placebo very from off-treatment, week my and of is understand Omav. a patients the the Omav transient treatment drop made to a want then started drug on X And rise. for patients in placebo of MOXIe Then shot patients, sense XX the you started you in to nice you switched very there's week was to all have from which, see early that to the that the whereas effect, X, you and continued again to see cohorts, way you to from mind, sense placebo and extension, and effect a the then you what

help me just delta cohorts. to you're preservation the between arguing want understand that, bit to show because could that a two a you rather see you than if a separation of So little

So I'm just a as – the what I'm bit little argument is. confused still to

So clarify, could Thank help you you. if please.

Colin Meyer

Sure.

on disease start have – well effect the of a study off-treatment to before one is point affects disease, separation groups, treatment be time again, part could blue drug and between drug And correct, you referring who later. expect if the a not been differentiation so the an a year as basically symptomatic a captured And you're of that would Omav. a by X. once treatment has important patients longer would period that effect MOXIe an underlying Slide benefit Part that was And start have the or to we underlying for the shaded that a actually region saw who is the on-treatment of patients the patients the which that treatment XX, between of if that receiving course as on on patients show

the extension And so, see to of the in you phase separation trial. want

lines I'll one extension. had the is And the the because different so, half simply a it be And there the can't first think reference patients points. drawing and prepared issue some points but And in in represents on analyzing on right, really missing analysis, remarks, figure completers left, done that that at state the mentioned far in it on is through interpreting first year I my different the with as people on and I data have the in the the time. call, primarily

first completed years. so they've you progression, same patients XX on so X.X right, set the Omav the the for And blue of a at patients looking those line, at minimal patients, if had look

treated have out And parallel. who extension the much separated. are roughly about point, that similar received look randomized see as patients, And on XX time to see that that are curves of were once Omav. Omav I they of they progression week And And with subset, expect. are initially they you course, the until flattened worsen exception a that And to can you'd you And and again, trajectory so, they patients the that's worsen. if then points can Omav. you than at, they initially mentioned, who X less placebo,

is that and complete overlap modifying. to And because received that so placebo for disease don't profile see. for want that drug the patients, the you want that would to a catch-up who suggest year, not and the was convergence see is you What

uses slopes. next the missing is the all from all overcomes patients. this And Slide the it especially in bottom the on available on It the data so because left present to phase. XX issue data, of is annualized the extension reason And table data

mFARS per data. is to points include obviously rate a best you X.XX And to if simply to analyze or out, were year, And data the so X.XX that all if the plot that's way – low which same two well points. how when overall And are those as match X.XX behave the comparisons, we They cohort were of have, FA-COMS which cohort. patients progression they worsened versus placebos. age the the then as

And it? your does question, so I think addresses that

Yigal Nochomovitz

Yes. appreciate just Thank And quick No, then that's you. that. I helpful. follow-up. one

in – a and barking, curious if dog sorry, might It to quite Obviously, Fast list. Pediatric, quite of Phase set list? that that something in long of significant success III, just the Thanks. breakthrough on of FDA would on unmet part mean, Friedreich's consideration I ataxia ever something I'm breakthrough also ever to. the Track, accolades FDA so Rare nice is the Orphan need. give that's only Drug gotten, be that seem is be want one from a you've So would you're shown a companies clearly would serious the

Colin Meyer

and program. to reason breakthrough late And breakthrough. access in allow apply that an review to on the easy to the our us We to too. one Designation division – reasons late the of was the basically is don't game the rolling the purpose primary a important really development game conduct allow it's in And for for have is Fast for for of to very was that And submission. a truthfully, breakthrough Track

communication because was in us. with close think helpful And so those FDA, to the all and for breakthrough that already are not reasons we I

Yigal Nochomovitz

you. Thank you. Got Okay.

Operator

Thank you.

Colin Meyer

eligible. We be do with you though agree should it

Yigal Nochomovitz

Thank you. it. Got

Operator

next you. today go Madhu, question please from The Thank Madhu ahead. Goldman comes from Kumar Sachs.

open. now is line Your

Madhu Kumar

for our Yes. questions. Thanks taking

delayed MOXIe updates analysis on extension from commentary question. that you kind the process? data additional see you up expect trial? to following the would review to open-label kind the want provide to related more I expect from of through the at granularly, Do of extension of updates more open-label guess start kind to So FDA Yigal's the

Warren Huff

showing NDA. was data submitted The This the we're data that Yes. the Warren Huff. is here that with is

data, data want to so it continuing they know if additional if the that and said patients they they see they're want to are and course, know. let they'll accruing basically Of is that over time. see us additional agency the We've additional data there the let

Madhu Kumar

Gap] a process? they think acceptance the of of for be those time amendments? kind should kind Like that of piece, kind major Would towards line [Audio they at we regulatory requests? filing? Would the did suggest about review of of disclose how that a in terms

Colin Meyer

Okay. This is Colin.

as of a obligated that provide. submission on safety. update And update, our the so And and we're NDA part review process, which safety XXX-day focus is to we of have

them Warren more we that we let as so, know that of part have update, safety efficacy updated And data said, that on falls the XXX-day is but side.

to determine division And the so, they efficacy if it's really want see data. to up additional to review

And or so, upon additional just may their know, efficacy it for ask depends not we They data. may and that don't view.

Warren Huff

will by the timing That driven be just the their Right. of NDA. of review

Madhu Kumar

question like Okay. or the last light open-label of One I kind statistical Great. are one Neurology They has obviously of questions MOXIe extension? in any the MOXIe process all terms of have of mean has you far analysis? on think guess review of analysis there for One? about kind viewed like in -- statistical performed kind so about viewed, been I there Have the is, how Neurology of any kind

Colin Meyer

we data is of have primary specifics did interactions reason with some including prospectively we we're this prespecified meet highlight to them. aware any So disclose But had of defined sponsors on and back the presentation, other Slide with forth may analysis. to of in the they've obviously XX, had we recent that one show cannot and the

that relatively some the Omav. obviously, to extension, a significant at data a of despite handle the sections then XX. of discontinuation mFARS, amount And again, have imputation, X% overall, missing low we've COVID, once all missing had and you all due week populations analysis We rate. no data, remains X% matter value low P how And favor I highlighted

directly without that that has program. division so the issues our And other some less your raised sponsors I'll with this note appears question, answering to of relevant

Madhu Kumar

so Great. you Thank everybody. much

Operator

Thank Annabel, from ahead. Samimy you. The please Annabel next question go Stifel. from comes today

open. now line Your is

Unidentified Analyst

on given This for to file and investors is limited around our but division Stacey taking for calling all controversies Thanks question. that programs cores. reversal now, allowed CNS the skittish are in FDA about clearly then over FDA's Omav, [indiscernible] right reversing data, for were I Annabel. guess

will were – sufficient from So missing FDA's aside fact indications? in in outcome see be then the different patients you also they that in programs we'll And evidence what patient handling the provide whether from XX comfortable with conjunction are the And the you gets delayed different start that unpredictability? data? Omav a how the these will

Warren Huff

is start. you One. program the with program from Okay. quite that in Omav by Well, programs CNS that Every And in mentioned this the with is division unique. recently ataxia is and Friedreich's were I'll Warren different Huff reviewed our patients Neuro other been

develop itself, struck effects. So of couple there's neuromuscular in the than it's Number worse years at things average very the the close mFARS or in end their no leaders on group just FDA they're key age had also They Pass seen and diseases of much been worst of the endpoint. opinion to one, rate with distinctions. a the Friedreich's a study, key point. suggested life-shortening it. patient of and ataxia XX other one advice of There the the disease is argue – disease. young, cooperation terms approved the input has disease it's progression and the I FDA the on old. good which provides data would a that their of and therapy XX followed that these There's set patient for the data development by on patients. on group XXs, longitudinal meaningful

We set, we Colin explained, FDA very And different, the say primary the I'd they that reviewed. so has endpoint. for endpoint. the mFARS indicated cleanly approvable just an writing also from hit times other basic data that our those think, endpoint as just some I believe in straightforward. of multiple is is reasons, it's things

that. believe there's over so, we controversy real don't And

We same is the different. should just the that will FDA want say on data think to I'd again, program that, that the hope So Colin, and every way. support on address the do it balance start? see you question the delayed approval support

Colin Meyer

Sure.

And so data. to analysis allow delayed further the a FDA us requested extension start to interrogate

of is data analysis every FDA delayed publicly week has we've Obviously, is point the in less NDA, primary FDA. extension their of our again, for from left. extension. pieces which so on And on figure the limitation disclosed longest, I lower some been missing provided there be The is set think of two the than we've expected. was why the much what start points. showing there of and so the analysis start and And help Once what the rate Slide is XX, but start. delayed completers the that the data there patients the that delayed one on patients in progression on XX, analysis that's is you're we right you referencing would the full think and performed us, conducted so mentioned And that And a the time much we've analysis on the additional all drug who've XX I data. is than

in data all is the extension. other The

progression, it's the across and approximately mFARS than rate extension Xx entire compute much. I point, as to XX assessments set data so, who their there is so of XXX mFARS from And all benchmarks use we half formal a MOXIe the when mentioned of that analysis X the patients the Part And were when X. patients, our during that's the same less primary presentation, and rate in show

gives we the that and briefed And us NDA. comfort that heavily so in

so think the the data. to missing to tackle COVID, due data that I way the for allows robust best a of more this is And much characterization

Unidentified Analyst

much. so you Thank

Operator

question today Jefferies. from from ahead. Maury, next The you. please go Raycroft Thank comes Maury

Your line open. now is

Unidentified Analyst

question. elaborate portion Thank question you the see in Maury. Part for on like large the taking also extension not had delayed Farzin on start analysis. placebo X? you the patients a you I on is do MOXIe This see the the improvement Can our why in

Colin Meyer

in improvement an is there extension. So the

make be the trial. should of to the baseline point reference the think I the at first beginning that is point not

XX, point. you're Slide the So it should time XX if week be to referring

only X two the they year. And received the progressed years, on Omav data that progression can some is is missing so on over again, right, one on over the And And before they which that And over not is progressed time, then the a limitation you point. patients left much a next half the one again, there data. those side. once same and patients points see on left there's the once

the not it's same So patients over time.

long it's Slide progression rate to if low improvement the again And there so, weeks, showed see slight can week you that's once well But you're on the XX figure a of we a improvement, within time, is in rate to the referring as figure on as extension period in as each that the data, first the the of table the the on see And not very XX progression. over different left, of XX XX, is right. the left, on the other. and a from annualized seen slow

Unidentified Analyst

an from And process, do the it. analog rely AdCom for data any Omav is from reviews the the since review will any of completely then will you way, or Got bard, bardoxolone discussions on in think FDA become independent?

Warren Huff

in that unclear. most CNS obviously perspective, induces from It's the design, syndrome dose, similar separation and penetration entity, MOXIe time. of cardiac Omav risk is output bardoxolone where And trial with in no – related the safety are different a with a to PD period that treatment the a from any mechanism and over distinct properties, patients. background different increase off And FA evidence cardiomyopathy, issues of has not PK chemical perspective there's been those furthermore has of to it that different action despite NrfX while relevant MOXIe. issues a highlight

slightly actually MOXIe there serial And We imbalances findings. X, no there on lastly And this down are were no blood common so echos population. It's because SAEs, ECGs back Part are findings. conducted there serial and Omav. elevation patient in no Then no are in of finding we arrhythmias conducted adverse events, pressure. with

FDA to we look data not bardoxolone. all the so much there appear to does relevance. when could But review And potentially be

Unidentified Analyst

you. it. you. Got Thank Thank

Operator

The question today next Charlie ahead. Moore Charlie, from you. Baird. from please go comes Thank [ph]

Your line open. is now

Unidentified Analyst

would – the data indication pertains that considering it Alports discuss as you've Skorney. AYAME Charlie for spoken would as patients. I about the you Thanks is about Thank a and This the will be guys. to taking FDA be be Brian And study, the Hi bardoxolone Japanese with what for to that you. needed question. if from on and acceptable different how in as Alport. for specifically if in ask well resubmission wanted just it's in

Warren Huff

Sure. that take This I'll is Warren question. Huff.

that in priority mentioned was FALCON our patients study remarks, I the agency alignment ongoing with the had our make to in, we As in sure first ADPKD. with

I on A submitted we Type minutes We so We requested get detailed we FALCON that the that issues meeting. amendment reach to Alport syndrome, and addressed positive interaction, And received the alignment recently did on to were that key of A a alignment them changes if the to to the Type be is protocol resolution protocol available support allow then the move that approval. completed we They were And with effects. the one endpoint And acceptable that we primary would a AdCom modifications did in NDA them. the made would it felt changes. week mentioned, based that course there we of the accommodate as and other XXX. the had on with data raised indicated

in example, ADPKD. my integrity to from analysis the the said, well, I most the standpoint an thing For ability went was preserves approval and of trial important in went as this plans, with the forward move that that

meeting to requested the division yet discuss haven't forward from syndrome. a path in We Alport the

view. after PKD. those we With our respect As obviously the will the to We interactions we just for and and doing have trial that be just completed I AYAME interactions the is report of will them. said, this results

We large its of risk with shown the the stage end be design such events have long-term predictive your been of is AYAME the haven't that trial or to reviewed with of implications But disease. yet. a very study trial endpoints the because FDA kidney

think The are improvements been with in types that estimated addition bardoxolone. data multiple will always the that has important to an across do be central question the on I the data bardoxolone observed consistently failure? in and dialysis Will a they're based kidney CKD. AYAME hard those number, translate into the duration a the trial, large Just risk events. size on have to going reduction the of of of GFR

failure. that multiple the thresholds set risk well they up endpoints XX% addition, are I to were XX%and of that predict XX%, In EGFR of decline, believe kidney validated

think diabetic same same specific the it's that because not though improvements mechanism of is single disease, in the even you in observe study, based form I to a action, GFR, any CKD. Japanese of So on kidney it

I also add, will of disease have long-term failure. I'd the data think it in at also persuasive in regulatory effects on risk bard, nephrology the was that it's the will patients BEACON kidney study, that and community of be treated that of being very trial. agencies the population safety convincing diabetic treatment with in risk provide since the additional kidney their are

also will of of provide additional it so And long-term safety an large body information on bardoxolone. use

Unidentified Analyst

Great. Thank for you so answer. much the

Warren Huff

Sure.

Operator

Leerink. question please Joseph, you. today Schwartz Joseph from Thank comes go The SVB ahead. next from

line Your open. now is

Joseph Schwartz

very for It bardoxolone things think for a that prepared yet regulatory you've major seems And well good could a some received of All and of [ph] bardoxolone surprises. the next said lot I feedback. right. there a said some Thanks lot really much. and steps same stage, like pretty you at similar be were

in anything doing Thank of you if So avoid order you any this of been we've is particularly think out during been the of agency, you're call. that the that of negative here I or different particularly different and was to there's wondering [ph] decisions you. hope coming anything if as surprises of have trend major on this fundamentally and kind all the even division

Warren Huff

Friedreich’s Yes. Thanks the of for Alport Joe. Omav This our ataxia in there key of address think differences, syndrome obviously is Warren, program several versus are in I I'll Yes, regulatory that. bardoxolone. profile

and to the neurologic The high controversial. presence suppressed mitochondrial say not ataxia respiration between is because relationship that the that function. target function They target. in ATP understood was the done and The production function research and showing the studies be the key mechanism FA is neurologic the understood. the to a which in severely would frataxin to key had mitochondrial just be community. respiration, disease the There's Friedreich’s I by is research that our correlation between well of identified, really is a body silencing us we genetic First, target known action through NrfX whole was clinical in It's activate well well is – approached believed is disease. this done of molecular mechanism impaired tools mitochondrial patients. NrfX

number an group like patient and not It's move exam. relevance I'd Colin, it's want are their that Yes. and like a over understood add the that patients has and that? researchers do endpoint, endpoint, relentless is of then well the arms in is of it's neurologic a characterized. the endpoint really because stand, laboratory out clinical it's overall, the either That across of hands. to of well measure a neurologic and to been you just clinical the progression, time. board, a Number FDA essentially a two, the kind of nature their And just is great work add have the rate the of of studies the of But then said either. right. depending controversial, one., the and upon reverse just GFR target clinical that primary got ability data where walk, doesn't So the intermediate direct in Friedreich’s disease It you've extrapolate not controversial that done the or the to the endpoint endpoint, – is fact have and the function It's clearly things to to view endpoint, And function. measures not it's patient's measuring totality data. clinical ataxia the

Colin Meyer

Yes.

few those a there So are I well. points as are and two others think excellent

endpoints beyond So the the Omav not of profile mechanism is clinical and the controversial.

and bardoxolone all clinical be And controversial. in drug profile as with know with with that's controversial kidney what similar no increases a been progression is the is And finding There's recovering that obviously Omav. such function some bardoxolone proteinuria. would I controversial Whereas then are function with of expected has think other increasing that so efficacious. slowing we there's elements

bardoxolone nephrologists the is would no belief vocal a utility obviously say hasn't that KOL ago We I it I minority that spoke that important while approved at thought in controversy no no have Whereas is on is have clearly those was there legacy that there used. similar And available bardoxolone. another drug some are that community there lastly, agents. about Another for there there impact syndrome was least BEACON the then been Alport had minutes ARBs in should any FA, that not though some even safety therapies a progression. is from that aspect one with a are that. demonstrated, And be the that and inhibitors the few finding to And drugs Omav, treatment believe with have is there finding. just don't effect, there trial. ACE

However, community. we're FA unaware controversy of any such the within

As the and well less data it's validated. U.S. clinical we I consistent our the several think are I why And the in mentioned is and because FA, at in controversy in included call, the mechanism study time the all the our there's reason interruptable, KOLs is globally.

reasons there's this than think many program why I bardoxolone. is different So

Joseph Schwartz

you. luck. Good Thank

Operator

from question Nochomovitz Thank you. Please from Citi. ahead. The next is question Yigal a go follow-up

line Your is open.

Yigal Nochomovitz

in cavus have I raised of Colin, the to pes breadth Hi very I question. Warren just thank and with the some to you you mean, well for significant, both the is cavus the a cavus. not patients are another Thanks. obviously much plan P follow-up. the here pes and look to What's for respect enrolled, XX value plan non pes was label label? as at you focus cavus broad although your planning Slide for the apply the the on again, non-pes

Warren Huff

on cavus. focus that label a includes would and we Yes, with patients without pes

think pes as regarding well cavus population. an important there's our I differentiation

basis were to ranging on Part that post cavus placebo severe noted small show controlled patients we that a treatment study from that Xwhich pes recall hoc effect. a less so was had And a MOXIe dose likely

with this could an a with would pes so And that think we treatment that's ability effect neurological abnormality obviously the foot. interfere that Omav. non is in case, have arch if patients And skeletal, cavus to detect high

the X, Part MOXIe this cavus. severe And patients prospectively pes it for population. cavus so defined with we really And was push pes

so patients. population, pes likely where any up not if light XX the estimate and randomized we a foot mentioned, did for their underneath the effect. included basically and And patients not that and we cavus used the see test is flashlight could high but arch the cavus pes in population in which a And saw was arch Furthermore, in the Omav we patients. you so show pes high, to study some improvements population, XX patients x-rays in cavus, define cavus cavus from but all favored expect many had of we point But was and those sections flashlight, as of it's a our understanding pes I We with are patients. all set, would pes them that significant manifestation you're reality, all who treatment There took as in right. significance non-pes mFARS. the of severe analysis the cavus, show of from we full significance stood in

So that as includes as bull upper bar, coordination. which and limb well swallowing is speaking

And factors any by foot. sections high are or their so that's arch those unaffected in –

that reasons include the a and those with obviously part broad discussions all of think be get label for so pes cavus. that patients should And will drug And we them. our with

Yigal Nochomovitz

lot. Okay. That Thanks a makes Thanks. sense.

Operator

questions in participation call. Again, on today's the queue. our you. no showing conference thanks And for Thank I'm further

Thank reminder, the after Reata’s will investor website@rietofarmer.com available call very section. for on participation. of shortly recording much an a the call be audio As in you your the

disconnect. now may You

Reata Pharmaceuticals (RETA) 10 May 222022 Q1 Earnings call transcript