RETA - Earnings call transcript Q1 2021 | Reata Pharmaceuticals Inc

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Reata Pharmaceuticals’ First Quarter 2021 Financial Results and Update on Development Programs Conference Call. An audio recording of today’s webcast will be available shortly after the call today on Reata’s website at reatapharma.com in the Investors section.

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

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

Financial by Executive Development turn and Chief Officer, We today Reata’s Chief are At and Executive Commercial Officer, Chief Officer, Dawn Officer, joined Officer time, Reata. to Chief Warren like of Warren Bir. I Meyer; would to Huff, Research Chief Manmeet Huff; Colin this the Soni; Chief and over call Operating

Warren Huff

you joining today. Good morning, for us everyone thank and

updates We with have a number that we this morning. you excited share to are of

will X. start on We Slide

subject, we our timeline course, our key during commercial The Drug will meeting also on Alport the a of it line XXXX. for months, and We’ve for we and of advised meeting States, under PDUFA the discuss the application is review had the drug application. for to this of year. actively us bardoxolone in our With the review an caused it disease the for team will by are focus with date the FDA. approval The chronic decision been are filing preparing with and by hold recent FDA Committee our for kidney U.S. United patients pleased continuing several planning for to syndrome. Advisory the standard FDA be XX, application February bardoxolone assigned application that accept the NDA, launch Food new review treatment off, a to last of time of to preparations for First the our Administration’s clarity the

Our and include and the patient processes in place marketing, core in U.S. distribution. support These are market organization, commercial for leadership team and launch access, building is of infrastructure the the sales, already bardoxolone systems necessary we

We Bir, are pleased to call Chief the have from this about to Officer, our us look on later call. commercial hearing preparations our Commercial forward launch Dawn her join and more in

Next slide.

bardoxolone kidney with in call completing study by Beyond significant the the of and enrolled to disease. for of XX polycystic the X, patients made acceptance in enrollment FALCON our for we we autosomal continue our syndrome, our dominant Since year. last our over patients end of anticipate have in bardoxolone progress filing we’ve March earnings NDA Alport FALCON of on

detail readiness Dawn will and that turn to omav’s would preparations. commercial steps call supports provide from in therapy previously the At ataxia, the data analyses pipeline. in the analyses. FDA our we to occur with neurology Friedreich’s that our to MOXIe delayed-start Regarding the study which for program recently omav trial, development as then we positive over request program. will plan I present pivotal like that in our from on FA the to discuss believe Colin, a scheduled to meeting, disease-modifying introduction, we pivotal is ongoing a Type the baseline recent With potential FA who The updates for granted C delayed-start our controlled this meeting, results more next quarter. discuss reported and

and Finally, our financial Manmeet will review an update. operational provide results

Colin Meyer

cause with that is of kidney development promote kidney patients rapid low hypertensive such progress risk of in faster Xx will high risk to programs. due syndrome by The common which severe rapid form patients pediatric with syndrome a XXX% tract. severe congenital ADPKD. rates our in Thanks, caused common failure. failure and Warren. Alport The Unlike actual of shown which is of syndrome to X, the generally other syndrome of then forms and urinary is Slide CKD, review of provide Alport collagen lifetime patients have of I progression on kidney progress slowly this kidney the a which failure of inflammation, kidney of most patients. of rate our in slide. in progression syndrome than Xx progress of and of as CAKUT, rapidly will the Starting on more syndrome than failure Xx abnormalities overview forms children, Alport have Alport very kidney hereditary by level and a loss function. is the progresses mutations high of patients as fibrosis approximately caused to CKD, of the very of diabetic, progression more CKD, forms observed rate syndrome, other most Alport Alport more Alport Adult with pediatric program, in is

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Next slide.

inflammation modulating mediators have is reversible can the and inflammation GFR in CKD. discussed of chronic chronically the all persists loss anti-inflammatory of As also these feature In and which stimuli loss which complete is NrfX, as dynamically forms reduces effects, kidney and key effects CKD, single-nephron the a ultimately, nephrons. many with persistently present, and Proinflammatory activating long reversibly time, CKD, targeted syndrome. Kf. of function we periods structural and suppressed irreversible does it by chronic Proinflammatory of or of CKD, a protective of fibrosis dynamic Alport for tissue including to Alport contributor Over The glomerular inflammation filtration quarter’s effects, it kidney is bardoxolone last irreversible it single-nephron factor effects. surface of area over result transcription regulate progressive primary processes is with remodeling GFR in in is including individual syndrome. time, by pathways. primary When of on forms call, associated CKD, almost drives including two profibrotic numerous function forms a

slide. Next

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Next slide.

were not Adverse discontinued occurred safety no and similar summary, database first mitigated end retention. adverse we patients. new believe reversible been our of Fewer against average, Our with did within patients XX with safety who were weeks, Alport have was signals ongoing extension discontinuation X,XXX that and generally XX. demonstrating has to and treatment. profile. an and In pathophysiology that CKD acceptable adverse now syndrome these that life-threatening. safety were over patients, the received, for the serious bardoxolone study, We data demonstrated data on comprehensive bardoxolone-treated weeks patients underlying when X-year kidney demonstrate kidney of experience in safety benefit bardoxolone XX development mild-to-moderate, the syndrome, No an identified treatment identified events program findings of in risk and patients, safety syndrome. By of a any bardoxolone treatment the profile targets placebo-treated study. development on the of our these are Alport not syndrome fluid programs consistent the observed events patients support for the findings. in had other were Alport Overall, data discuss I clinical of will risk positive acceptable efficacy our Alport our Slide function

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completed with appropriate have volunteers this a study in SAD to will initiate turn no in scale. pain. using acceptable diabetic an pain and now the our in have on achieving with standardized to be MAD commercial placebo-controlled to Bir, discontinuations we neuropathic a SAEs, signals, to and our peripheral Commercial of Chief a In of or X quarter safety while study planning Phase XXXX, the X provide study fourth readiness the patients Dawn pharmacology will studies quarter margins. Phase clinical call I support drug an safety of second the profile bardoxolone. healthy launch year We studies safety This Officer, demonstrated of dose-ranging update over randomized, are

Dawn Bir

everyone. Thank syndrome, bardoxolone launch will first treatment of It’s you, kidney Colin. no deadly the therapy. as I XX. exciting with disease an commercialization very approved start prepares our and Reata potential Alport on the a rare time Good for Slide morning, for and of

timeline our is February acceptance the clear. our of NDA XXXX, filing date of With PDUFA and of XX,

launch and support reports hired have function. readiness their have QX each to leadership commercial and to direct XXXX We ensure taken by commercial steps conservative

to environment adoption market favorable a education efforts the support preparing disease designed actively been to also through create launch. at have We bardoxolone

Our of to platforms. awareness campaign to ago, education urgency through and objective launched treat is nephrologists therapy digital, launch recognize accurate year broadcast website, campaign Alport diagnosis access the social, is disease distribution over provide and patient the Alport payer disease is and reaches to also and us and highlight to priority. a Patient severity, to related facilitating availability and the The syndrome. identify approval. has print on at and landscape key payer reimbursement a approval. product research pricing a team support at access understand education The payer program needs help as Ongoing access to educational syndrome, designed critical market at

this also pediatric diagnosed can that there and adult patients syndrome where diagnosis right list States, planning launch X,XXX near-term nephrologists them presence, and planning. the to approximately reaching have and and launch them efforts Alport for for in have Through Alport majority on are a treating significant audience Alport by their refined to with allowing Currently Alport the data. slide. by indicates target treated opportunity United we represents the physicians their treating us diagnosed patients the today. These Claims commercial Next of located being patients and who’s data and Reata. is broad a nephrologists. claims XX,XXX further We’ve also are believe been volume in patients approximately Knowing patients launch nephrologists their through by influencers. expertise our This today key there management important treating be the projected identified market are diagnosed patients with practice. data, ICD-XX syndrome. peers syndrome recognized in the are of syndrome

introduction awareness and therapeutic disease. programs of a testing specific the increase genetic help the option to recognition efforts, may of Alport education syndrome and for disease Continued

now Shire strong to a experience operations leadership distribution to network years including packaging for pharmacy key all the is drug commercial launch leverage customer sales, place, our controlled XX, market and hub. at XXX assembled hired including QX, launch has has with BioMarin. prepared product fundamentals with advance seasoned will platform and tightly marketing, targeting finalized combined teams we Pharmacyclics, We’ve our Turning designed, a to support Alexion, team access. and in commercial been specialty complete. companies, and Commercial commercial Genentech, functions, patient Each Slide front-end commercial that and strategy. of successful grow In biotech product we are the a planning

Alport This events launch and accelerates, coverage They data key with reimbursement months, top directors upon coming will market place and As national be of regional pharmacy take several pivotal preparation of seek charged with in payers access our will disease. approval. the the syndrome and CARDINAL burden team about including directors. will of deployment share bardoxolone educating

cost Additionally, therapy. support adherence a we to our programs will will finalize reimbursement of onboard, patient first prepare our we small train gain momentum, and deploy specialists. force, access Branded and design services patient and sales development patient to will bolster out-of-pocket of launch and focused team nephrology to

financials call strong the forward a moving Manmeet very quickly for to turn the summary now are quarter. from foundation. I We will of a to over provide our

Manmeet Soni

Thanks, morning, first our operational Warren, for will our to the summary issued earlier Colin quarter of Please for and good press a our our X cash readiness. results today and position, everyone. I release refer be our Dawn covering QX and financial financial results topics: of XXXX.

our cash with on Slide Let XX. me start balance

As March a cash with approximately in through we sheet we solid balance balance end, million operations $XXX.X to In and our cash guidance, mid-XXXX. fund with our equivalents. expect maintained our current cash keeping of

for R&D $XX.X compared increased in compared to expenses, $XX.X the to million completed the and related the million offset for were quarter $XX.X NDA the year first G&A clinical expenses were our net spend. activities, of expenses regulatory preclinical to expenses XXXX. studies million expenses to with a Lower million to expenses quarter of quarter for manufacturing $XX.X and Moving spend primarily prior first for our due quarter R&D XXXX. were decrease by for submission. the G&A consistent were

same $X.XX $XX.X diluted both million million $XX.X basis loss for $X.XX and or net and to a basic share share was both loss compared first of the year. net or as per on prior the diluted GAAP on quarter Our basic for basis per XXXX of period of the

primarily loss basic non-GAAP same both both to $X.XX $XX.X and as on per share compared million for loss of year discussed was $XX.X first of on period net recognized the in net for first expenses and diluted XXXX of million a $XX.X driven R&D The of to Act $X.XX in diluted the CARES tax net a a the earlier. of is per non-GAAP million we by recognition prior. the and that a loss benefits non-GAAP increase related share or basis GAAP basic decrease offset the in quarter by or Our basis totaling XXXX quarter

Moving to our million Slide for on non-GAAP the were measures compared prior. of XX, $XX.X million first expenses for R&D quarter to as year non-GAAP XXXX the $XX.X the same period of

G&A quarter and Our the the expenses pipeline as million for of quarter commercial non-GAAP readiness period expenses to multiple were potential To million the first XXXX non-GAAP summarize, compared key were our $XX prior. activities. regulatory the and during the with reflecting programs, million of for launch of first $XX.X same of $XX.X our XXXX year operating

Next slide.

operations are launch From product We investigational to early current to and Reata’s and an commercial next our approval. strong planned adequate standpoint, the of ensure XXXX and necessary the manufacturing planned making pending XXXX meet investments and review FDA of potential and and year, is demands. successful inventories commercial bardoxolone product

development, We in and key to ensure registration engaged availability across activities are bardoxolone approval the CMC beyond. and post program commercial actively validation

and syndrome. for disease invest the team and in We Alport community expand our awareness to continue education affairs medical to in increase nephrology

With to platform beyond. over call several infrastructure and next long-term the goal becoming support and program, years product support multiple capabilities Alport a launches Beyond our additional building Warren. that, the indications I of over our providing syndrome new that a back to commercial global are the will turn we entity, and

Warren Huff

Manmeet. you, Thank

across As our presentation today programs. we’re significant making set broadening our progress indicates of

a of our pending FDA focused We bardoxolone syndrome. next FDA review a Meeting Turning preparing Advisory Alport FDA commercial our NDA for approval. launch continuing regulatory to working have Slide XX, Committee with their the on milestone for fulfilled we year, remain major an in preparations during for in now

Additionally, our the authorization Union on remain file this MAA year. of quarter in European track we to in fourth the marketing for

partner year. Kyowa Additionally, planned of for bardoxolone caused the submission Kirin, CKD New the middle our syndrome treatment by to we’re by Drug looking the for Japan Alport Japan, of Application in this in forward

remain following next would questions. forward you omav our to remarks. prepared That program concludes we And will now Type Finally, look for everyone over the meeting to thank in call FA, on year. turn C for I to we advancing who and updating the this to our dialed later in. this dedicated the operator like steps

Operator

[Operator first of question Please ahead. Instructions] for Citigroup. go is Nochomovitz Yigal The

Yigal Nochomovitz

good on for Hi, the Alport Warren syndrome. NDA and And team, question. taking acceptance morning. Congrats the for thanks

So you the remarks actively the you’ve AdCom the mentioned, months. in been that prepared several Warren, preparing past over for

discuss you Committee the issues? be to to Alport, the will expect and you. issues could key be you what the you you are by So believe these Advisory raised preparing clinical regarding how bardoxolone Thank program in address

Warren Huff

have gotten outside the good I as think mentioned. review of Yes. help key Yigal. and, a for the the we’ve first-class that. Sure, in that program many leaders opinion as advisers of review as – course, Yes, that Thanks the by been, data I outside mentioned, active and and I with well preparation

around inhibitors. agents directly design in of the those key – of blood are improvements in we action. have pressure the was the It medications is of the the We observed CKD and mechanism SGLTX processes. program, effect been that basically approved anticipate off-treatment, see have the just the GFR analysis. mechanism a key a think frequently. are different Obviously, secondary not clinical issues issues novel It entity of very feature that treats inflammatory nice that been the than new molecular a our I a program. space, known Bardoxolone with has like previously the

review explored I at kind those be will think will of that and the process in AdCom. issues the be the key that issues

Yigal Nochomovitz

on thoughts you lack Okay. any the any Do of quick And standard of to priority for Got the review, opted approved given it. have just and syndrome Alport? follow-up. Alport one treat the why therapies FDA severity not

Warren Huff

molecular answer. It’s Again, the entity. that new it unlike mechanism. It’s has a same the bardoxolone approved. it’s that think I Well, agents novel a been is other have

the presents PDUFA And review. time of other themselves recently. also to wanted plenty just they review note I’d that issues dates have programs so it I review deferred to that think novel give two in on they

Yigal Nochomovitz

it. you. Thank Got

Operator

The is Please Gould of ahead. Barclays. go next Carter from question

Carter Gould

congrats how about a Could Or on from the level you you guess delivered wait that discuss FDA back acceptance. at you. Thank coming Good as that? going that coming meeting? call the something high think of Type meeting of sort to morning, and we omav are And anticipate to XQ that intra-quarter? out feedback sort scenarios just C I until range meeting, the potential of the can you to communicating be for have it? of

Warren Huff

that? like Colin, address would you to

Colin Meyer

Sure.

that evidence last we’ve since of year requested persuasiveness has to provided before so NDA. an willing accept they FDA guidance are And additional

we’ve try with so our will to provide to their program. collaboratively And additional we view influence hope on the that analyses working division been development

we’re so them and with we the we will will the in development be And us, the be will release steps guidance And we with it’s that second this on prepared quarter. to provide the to what clear need have findings quarter, next of the when meeting program. to –

Operator

with go The Maury next question is Jefferies. ahead. Please from Raycroft

Maury Raycroft

be data? a on progress, have Friedreich’s EMA’s Good questions. taking path views to just morning. if could I of question. the Ataxia follow-up any additional that in guess, and checking the Hi, there pivotal? forward clarity thanks EU my on the – for your everyone. Friedreich’s Congrats Ataxia you And I is the second on on just independent

Colin Meyer

the the in we and program. EMA, development incorporate that seeking the We’re process will from guidance of into

of require on they at additional no so may us. what have we this And point, comments

Maury Raycroft

Got it.

And for diabetic Kirin data expected study then X F’XX. Japan, – aren’t first until the Okay. in CKD in Phase

Or augment submit request there the blinded from of is possibility either any studies review? data blinded review? their from to help checking ADPKD those Reata FALCON Just that the FDA data with potentially study if or to study could potentially from some to for Alport

Colin Meyer

Yes.

as would request and they ongoing those Maury, studies So unlikely overseen monitoring data view that trials those we by it two safety board. are by highly ongoing, data that, any way, independent from the an are

Alport with dataset And XXX have Alport been include It of treat doesn’t bardoxolone bardoxolone, for have a so exposed filing with we it placebo-treated patients our other that syndrome. the to of X,XXX hundreds NDA approximately patients. who just who syndrome, people includes

in a rare disease. of syndrome very the such dataset is half for adverse actually as seen the very bardoxolone. bardoxolone FDA, then event past and in were in XXXX of enrolled relative any that or over Alport We we what this trials. placebo. have characterized. were in syndrome a And in profiles group cut our I’ve safety events for And serious believe There prior so to adverse no call, Alport similar signals discussed, that for in the calls, exposed profile a it’s to in in very the trial view, was trial in frequency XXX couple to program, we’ve since well large the XXX people trial observed retention The especially fluid

been them, is submitted. that of have the reviewed we most detailed in this all well NDA action, we for publications of from peer clearly, so And to data events specific we’ve just very And described. the our point safety is believe we characterize mechanism perspective, very interest that we’ve the pharmacology. is seen. And able that last one well that underlying describe of the adverse And

is And so very that it’s safety our profile view well characterized. the

Maury Raycroft

perspective. all It’s questions. helpful for taking Great. my Thanks

Operator

The go next of Annabel ahead. Please Stifel. is question from Samimy

Nick Rubino

Rubino, Annabel. is on everyone. morning for Good This Nick

for as our well congratulations taking questions. and thanks Our

in demonstrate of filtration? forced using increases? there rather eGFR eGFR can get to think along increases area at expect almost comfortable the to damage? I we with What due front the topic them as AdCom. well you’re be the else the than you FDA glomerular increases the And that to to to factors surface and center everyone Can you other are hyperfiltration provide with demonstrate that lack of are

Colin Meyer

Yes.

obviously, as the we’ve of novel I over bardoxolone. characterize many calls years, over on literally we, past to decade So profile a the spent talked about few

one of the Professor And single-nephron in the which shown living with constricted is He a working it’s in world, including And has he Kashihara pressure so is surface an preclinical imaging in GFR bardoxolone increasing – animals, in the studies, that the due we’ve of using Japan. area, increase in labs GFR forms a conducted to many CKD. the in an increase sophisticated due increase to President of top perspective, in and without techniques of the Society from few Japanese increases filtration kidney, is Nephrology.

been those so And data publicly. presented have

bardoxolone models peer protective. that demonstrated analogs that support findings. are We these We’ve in hyperfiltration of and have other specifically manuscripts reviewed other

is thoroughly characterized what there specific about our the relevant animal actually no perspective, so And And models. from is action mechanism doing. of drug controversy we’ve in the

syndrome that people. prove if you action for that, that, is independent the for bardoxolone in ADPKD. as for can never same as clinically, them it’s think allow they us is their to the trial of endpoint, mechanism a both served for basis FDA harmful, X-year of mechanism, mechanism the design in important since endpoint or beneficial approval to the would I gave why ADPKD. for well And design required note of that tolvaptan if acknowledges Recall, Alport have as view, the determine that’s trial they a this off-treatment and

at rules and And the years that amlodipine, years known that transit AASK peaked harm, with are channel a National small lost GFR disease-modifying one after acute assess X are the done the so placebo, GFR the beneficial. there a in a a Kidney was and in persisting versus in of of that FDA appropriately that changes type ongoing withdraw either times that. with sustained resulted profile have in is X on-treatment validates have it where they X working view to an of calcium only increase and versus or on way in that placebo twice hyperfiltration which effect activity Alport in increase GFR, the group blocker specific settings Foundation’s EMA, The study is increases the to any the drug and And for a extension which decreases called in view and is for drug, FDA’s both we trial, very not month out but syndrome of study. demonstrated recall

And We large of profile for purpose very again, observed the years. so this And the X address endpoint is different. once increases question. very to sustained the was off-treatment

once literally to up. both clinically, well Yes, And this clinically. is we described. this question, mechanistically hyperfiltration think may But and think again, years spend address I have come we so

Nick Rubino

time awesome data the that are follow-up, X-year in to the Thank a And review. be discuss of going FDA my with from you terms the you. of to was much able how that EAGLE AdCom? the Great, by actually kind of of leads into

Colin Meyer

X have that’s trial So EAGLE Phase through the years, publicly and from X patients. disclosed we data, obviously,

trial. are but We the Phase EAGLE still have the followed X, also many from Phase patients who being trial, X in

used data All we the of NDA cut the but the for that the NDA had, data were itself. included in

access data CARDINAL we beyond but that has data. publicly, it as the it data. disclose provides so And primary support matures, will we think those to all additional And FDA

Nick Rubino

you Great. much. Thank very

Operator

of Skorney ahead. Please go is question Brian next Your from Baird.

Brian Skorney

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

there to during First in bardoxolone the I of on will I’m is the one partnership FDA information data of have course your bardoxolone, review AYAME? as not Obviously, submit a actually, the with privileges you just part But be Kirin, of if just sure the would safety partnership to the FDA wondering of able if of that. the for what are, sharing to am access that? lot and any

Warren Huff

I arrangement, access is under but the trial it completed, blinded is when mean, have study. to No. an we data will the the ongoing

the the use to able of Alport being syndrome current during anticipate data that wouldn’t review NDA. we So

Brian Skorney

petition meeting sponsor. know leadership meetings was FDA. outside hold if I the And Type just with drug you currently wondering know of applications the FARA with going around has know C to that out I it. examples groups senior FARA meeting do new there? And know Got on I to a has you for advocacy FDA. be omav, where in the who’s attendance if then other the

Warren Huff

what know meeting. We you or C attendance the And activities are with requests, will respect FARA’s actually their privy who attend to but We we’re in the don’t not be with until you never know meeting. of at FDA. really to No. aware make the actually interactions Type actually

Brian Skorney

you. Great, thank

Operator

ahead. go Charles of Duncan is The from next question Cantor Fitzgerald. Please

Charles Duncan

on that Also, presentation. I for of question and I’m think ready guess pivotal the certainly, for seems Colin an there progress another kind quick clearly, study, of congrats Good NDA I you omav program. the AdCom outlined for you moving a morning Friedreich’s is or But Warren program possibility team, if study I wondering everyone. had acceptance. to on pivotal anticipate on a what another be XX. indication in or that another forward? candidate, – moving would do to to pointed Ataxia in the potential a different on see neurology could the next you going or steps Slide

Warren Huff

No.

positive we but committed disappointment that’s pursuing that prepared and or in omav execute do It think we Ataxia. pivotal yet hand. NDA we have feel and a relatively an have could the the for already a be And done able to that, do that it have a Despite may the have we we be have clearly positive in the FA result. been Friedreich’s since I will low-risk we’re we not well very to submit add we if to to to study, there one it. in efficient fact been with and a study approval way to study, patients are for enthusiasm will have done like repeat very a high study pivotal one largest of we another with

broad business have So, we set pharmacology finish in Colin we very that to of but applicable first. a is neurodegenerative earlier, believe to much the outlined FA diseases, as

Charles Duncan

of treat us being bardoxolone patients those demonstrates sense then see MERLIN strategy, you or that patients that shown clinical and total question regarding did think ADPKD in addressable I you it a another suggests will percentage able for take it’s included me And I total market, study, to probability amount activity question the Colin of but one to have regarding that That when Dawn the that in the give or patients can if or Yes. percent you total high about syndrome? Alport of progression? offline with the could have perhaps

Colin Meyer

or are only? you MERLIN population Charles, ADPKD specifically So to the referring patient

Charles Duncan

those of up? of patients you kind those could both, are if have ADPKD going split probability for or progression, high it’s you them but MERLIN, also who Well, to group

Colin Meyer

Alport think the is the now, number So, population. and we than PKD have larger just but the estimates syndrome right much we don’t obviously

progression. kidney, think kidney I that there typically approach treat is inhibitors pressure other ACE and what’s approaches ARBs. disease trials has been different the agents recently that the affects systemic within promotes that’s that several SGLTX namely They inhibitors underlying complement cardiovascular and that our conducted than affect the with about

out progressive to using that disease so all have kidney rapidly still intrinsic those targeting and despite MERLIN the disease therapies. trial, are available patients the and We identify that trying disease cardiovascular exclude have

are it’s but opportunity, we that to not think comment right willing so And broad. on now I

Charles Duncan

to target able provide certainly being to profile a not product ultimately that progression? this kidney may delay see you a be, if But disease-modifying

Colin Meyer

Alport are Yes, into ties is syndrome progressive. at as for Alport who I been and And risk syndrome. for it’s thesis lost patients our bit this a discussed and here that extremely think rapidly little I

Alport average. it’s okay, And so failures still syndrome X to But people patients, I future. mean, have on it’s presented it seems X far see think to, the I slides more I Alport off plot. the progresses years you figure kidney syndrome, minutes the first the but for in few few faster, a and

just And disorder so or we not their are that some in kidney the at are targeting patients and likely to near-term. inherited lifetime, but for in failure, like acquired who risk progression have

Warren Huff

Yes. for the near-term relatively And not just the in but near-term, in patients. young

Charles Duncan

Thanks taking question. Excellent. for the

Manmeet Soni

where the right concept, we etiologies, rapid that’s for CKD. the in think whole of on whole risk concentrating only I the of And right, that’s concept multiple are MERLIN, those progression

Charles Duncan

Manmeet. the Appreciate color,

Manmeet Soni

you. Thank

Operator

Schwartz next SVB Leerink. Joseph [Operator of is ahead. question Please from Instructions] The go

Joseph Schwartz

FDA a heading omav. actually into them soon. very to both ask of I was of important wishes for hoping on and meetings best and bard couple thanks Hi,

with things on many the taken that life be granted in First the sponsors for past. to FDA be taking issue bard, seem seems making difficult by for to lately

nowadays? confident seems bardoxolone followed any page new this markets to division with required bring on have and that it increasingly are the the that you a how be TE, reviewing So, are their like you drugs market will to – to you same guidance because

Colin Meyer

us serves dating so agency syndrome, in They with design the with Alport with the to have transparent basis discussions for They that approval executed. which Joe, which trial. gave for had we’ve the the we pre-IND that for FALCON XXXX. our a the meeting we trial, Alport mentioned I our previously, think for gave I been same same us as back endpoint as the design syndrome tolvaptan. And it’s

what told And executed it. so perspective, we’ve believe us there they to discrepancies the design what don’t they statistical executed. any plan. what between do we do. perspective, and a have From analysis We’ve our told We defined us analysis from to is is an

transparent the analyze the FDA we way we the course, filed data. Of being with have it with that

I So can And done to I that from it’s trial the think other. and conduct all to we distinct the analyze transparently think FDA. do and data provide that we’ve

I that us. So the you that don’t recent to issues – I think alluding that think may be to don’t are relevant

Joseph Schwartz

I mean, refined that helpful. Okay, STAT work. plan yes. be Thanks. recall that a That’s to you I good proactive seemed

So will help. hopefully, that

Type upcoming already the for was And what’s establish the omav? expected omav. I on much have what meeting the former your required analyses that purpose C curious just versus if of now be Now delayed-start is discussing of will on how next you focus pivotal the latter is trial for the to required?

Warren Huff

delayed-start going if disease-modifying view believe are We’re will agrees they in data and and activity of what’s program to discuss them development that a the where would And generated interpretation because position so important overall we demonstrate we’ve it’s set analyses. differently. FDA put that the new the data that the

it hopeful date. It’s successful once it’s will not And upon delayed-start will that are analyses. the again, the of data occurs. data once a And all outcome But have just program again, of provide so development we and guidance about about once review we we that meeting. generated to about the overall

Joseph Schwartz

my taking Great. for That’s questions. Thanks helpful.

Warren Huff

You are welcome.

Operator

gentlemen, participation today’s and thanks you. showing Thank this I’m Ladies conference. on in the queue And no at your further questions time. for

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

now may You disconnect.

Reata Pharmaceuticals (RETA) 9 May 212021 Q1 Earnings call transcript