Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Q1 2022 Earnings Conference Call May 10, 2022 8:30 AM ET

Company Participants

Warren Huff – Chief Executive Officer

Manmeet Soni – President

Colin Meyer – Chief Innovation Officer

Seemi Khan – Chief Medical officer

Dawn Bir – Chief Commercial Officer

Conference Call Participants

Yigal Nochomovitz – Citigroup

Madhu Kumar – Goldman Sachs

Joseph Schwartz – SVB Leerink

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. These non-GAAP financial measures are reconciled with comparable GAAP financial measures in Reata's earnings release and presentation from today, which again can be found on Reata's website.

Today's statements are not guarantees of future outcomes. Please also note that any comments made on today's call apply only as of today, May 10, 2022, and may no longer be accurate at the time of any webcast replay or transcript reading. Following the prepared remarks, we will open the call up for questions. We ask that you please limit yourself to one question and one follow-up so that we can accommodate as many questions as possible. We are joined today by Warren Huff, Reata’s Chief Executive Officer; Manmeet Soni, President; Colin Meyer, Chief Innovation Officer; and Seemi Khan, Chief Medical officer; and Dawn Bir; Chief Commercial Officer.

At this time, I would like to turn the call over to Warren Huff.

Warren Huff

Good morning everyone. We thank you for joining us today for our quarterly update. I'll start on Slide 4. As you all know, we're developing omaveloxolone, or omav, a small molecule activator of Nrf2 for the treatment of patients with Friedreich's ataxia, or FA. We've made significant progress with the program over the last few months. Following the positive results from the MOXIe Part 2 study, we had multiple interactions with the FDA to determine whether there was a path to submission and review of our new drug application, or NDA. This was highlighted by completion of a pre-NDA meeting with the division in the third quarter of 2021. Following the meeting, we applied for and were granted Fast Track Designation for the program, highlighting the potential of Omav to address the serious unmet need for treatment options for patients with this devastating disease.