Reata Pharmaceuticals, Inc.

Good morning, everyone. We thank you for joining us today for our quarterly update. As you know, our new drug application for bardoxalon for the treatment of patients with chronic kidney disease caused by Alport syndrome is currently under review by the FDA. Alport syndrome is a severe, rare genetic form of chronic kidney disease with no therapies specifically approved for these patients. The FDA scheduled an advisory committee meeting for our NDA on December the 8th and we've been actively preparing for the Advisory Committee meeting. Colin will expand more on this later in the call. The PDUPA date for the NDA is February 25th, 2022. In addition to our regulatory activities, we're actively preparing for commercial launch of Bardoxalon, subject, of course, to FDA approval. Additionally, we recently announced that we submitted a marketing authorization application to the European Medicines Agency for the treatment of patients with CKD caused by Alport syndrome. Finally, we recently reported that we completed our pre-NDA meeting with the FDA for our development program for OMAV for the treatment of patients with Friedreich's ataxia. FA is a severe inherited degenerative neuromuscular disorder with no approved therapies. We're in the process of completing the NDA and plan to submit it during the first quarter of 2022. I'll now turn the call over to Colin, who'll provide an update on our preparation for the FDA's upcoming advisory committee meeting for Bredoxilone, a clinical update for Bredoxilone in rare forms of CKD, and a regulatory update on our program with OMAP for patients with FA. Next, Don will outline preparations for commercial launch, and finally, Manmeet will provide an update on our financials and operations.

Thanks, Warren. And good morning, everyone. Starting on slide five, as Warren mentioned, we have been actively preparing for the advisory committee meeting for Bardoxalone, which is scheduled for December 8th, and I'll provide more information about our preparations. We are pleased to report that we recently submitted our marketing authorization application to the EMA and look forward to working with the EMA towards securing approval for Bardoxalone for the treatment of patients with CKD caused by Alport syndrome in Europe. We are also happy to report that the MDA submitted in Japan by Keiwa Kirin, our strategic collaborator, is currently under review. We are also working with Keiwa Kirin to assist them in the regulatory process with the PMDA. Turning to slide six, we continue to actively prepare for the upcoming ADCOM, and we have submitted our briefing book for the meeting to the FDA. Over the past few months, we have been working with external key opinion leaders in multiple disciplines to join us for the ATCOM meeting. Additionally, we have already conducted several mock meetings and question and answer sessions with former panelists and regulators to prepare for potential questions and discussion topics. We continue to refine our analyses to ensure we'll be prepared for an active discussion with the committee on the efficacy and safety profile of baroxone for patients with CKD caused by Alport syndrome. Next slide. Moving to our program in autosomal dominant polycystic kidney disease, the most common hereditary form of CKD, we are continuing to conduct our phase three Falcon trial. We are currently enrolling patients across approximately 100 sites globally. Last quarter, we announced that we had received feedback from the FDA regarding our ADPKD program following a type B meeting. The primary endpoint of the study is the off-treatment EGFR change from baseline versus placebo at week 104. We will be analyzing the primary endpoint using only data at week 104, irrespective of time off treatment. Patients who discontinued treatment early will have shortened treatment exposure and a longer off-treatment duration, which is expected to dilute the treatment effect. We are increasing the sample size from 550 to 700 patients to account for the dilution and treatment effect from discontinued patients. More than 450 patients are currently enrolled in the study, and we now expect to complete enrollment by the middle of 2022. Finally, on slide nine, as Ward mentioned, we recently reported that we completed our pre-NDA meeting for development program for omaviloxelone for the treatment of patients with Friedreich's ataxia. The purpose of the pre-NDA meeting was to discuss the content of RIADA's planned NDA submission. Based on the results of the pre-NDA meeting, we are not planning to conduct a second pre-approval clinical study prior to the NDA submission. In response to our questions about the contents of the filing and because of the seriousness of the indication, the FDA exercised its discretion, subject to review, to permit us to submit results of certain clinical pharmacology and nonclinical studies after approval. We will continue to finalize the NDA package for submission during the first quarter of 2022. With that, I would now like to turn the call over to Dawn to provide an update on our commercial preparations.

Thank you, Colin. Good morning, everyone. I'll continue on slide 11. This is both an exciting time and a unique time as Riyadh now has two potential product launches in sight. As we look ahead to 2022 and a PDUFA date of February 25th, we are actively preparing for the launch of Vardoxelone for the treatment of CKD caused by Alport syndrome. and inherited and rapidly progressing kidney disease with no approved therapy. Following the positive news of our pre-NDA meeting, we are also reinitiating launch readiness efforts for omaviloxelone. If approved, omaviloxelone will be the only FDA-approved treatment for Friedreich's ataxia, a rare and life-shortening neuromuscular disease impacting children and young adults. Our commercial infrastructure is in place, including our core leadership team. a team of experienced biotech professionals representing marketing, market access, commercial operations, and sales. We've hired, trained, and deployed Riatta's first payer field team with an initial focus on Alport Syndrome. Their primary responsibility is to facilitate coverage of our products to label following approval with the top U.S. commercial payers, Medicare, and state Medicaid programs. Recent pricing and value research confirmed our previous studies reflecting that both payers and physicians see high unmet need in Alport syndrome and placed high value on a specific treatment option when presented the Bardoxilone product profile. We've identified highly influential thought leaders who shape the treatment landscape of CKD, rare kidney diseases, and Alport syndrome. We are now leveraging their insights through final market research and preparing engagement plans that support commercial launch pull-through. Customer targeting and segmentation is complete. This was used to determine our appropriate nephrology sales force size and territory alignment. On November 1st, our team of nephrology region business directors joined RIADA. Their first task is to build our sales organization, identifying experienced kidney and rare disease sales professionals to join our team early next year. Now with Friedrich's ataxia back in focus, we're advancing similar commercial work to prepare us for the launch of omaviloxelone in neurology. For both therapeutic areas, disease awareness efforts will continue through approval and launch, highlighting the significant unmet need, the urgency to treat, and the severity of these life-threatening diseases. I will now turn the call over to Manmeet to provide a summary of our financials and operations for the quarter.