Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Q2 2020 Earnings Conference Call - Final Transcript
Aug 10, 2020 • 08:30 am ET
Hello and welcome to the Reata Pharmaceuticals' Second Quarter Financial Results and Update Development Programs Call. My name is Sheryl and I will be your operator for today's call. [Operator Instructions]
Before we begin, I'd like to go over a few housekeeping rules. An audio recording of today's webcast will be available shortly after the call today on Reata's website at reatapharma.com in the Investor section. Before the Company proceeds with its remarks, please note the forward-looking statement disclosure of the Company's press release. The Company will make 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. Today's statements are not guarantees of the future outcomes.
Please also note that any comments made on today's call speak only as of today, August 10, 2020, and may no longer be accurate at the time of any webcast replay or transcript rereading. Following the prepared remarks, we will open the call up for questions. We ask that you please limit yourself to one question so that we can accommodate as many questions as possible.
Please now welcome Mr. Vineet Jindal, Vice President of Strategy. You may begin.
Thank you. Good morning and welcome to Reata management's call to discuss our financial results for the second quarter of 2020 and to provide a review of our development programs. This morning, we issued a press release with a summary of these results and the press release can be found on the Investors section of our website at reatapharma.com.
I'm joined today by our Chief Executive Officer, Warren Huff; our Chief Operating Officer and Chief Financial Officer, Manmeet Soni; and Chief Research and Development Officer, Colin Meyer.
Before I turn the call over to Warren, I'd like to remind our callers that we're limiting questions to one per caller please, during the Q&A.
Warren, I'll now turn it over to you.
Thanks, Vineet. Good morning, everyone. And thank you for joining us on our quarterly call. On today's call, I'll provide an update on a regulatory path for a lead products bardoxolone and omaveloxolone. Colin will summarize the status of our ongoing clinical programs and Manmeet will review the Company's financials. I'll begin with an update on the status of a regulatory interactions with the FDA, with respect to the potential approval of bardoxolone for the treatment of patients with Alport syndrome on slide 5.
So following the announcement of year one data from the Phase III CARDINAL study in November of 2019, we've been engaged with the FDA to discuss the year one efficacy and safety results. We've had a Type C meeting where the FDA expressed concern with basing an NDA for accelerated approval on the year one data alone and recommended that we consider submitting the NDA with the year two data. We believe that their recommendation was based in part on their assumption that there would not be much delay in NDA submission by waiting for