Item 7.01.Regulation FD Disclosure.
On November 9, 2020, the Company issued a press release reporting the results of the Company’s baseline-controlled study, or crossover study, of omaveloxolone in patients with Friedreich’s ataxia. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference.
On November 9, 2020, the Company issued a press release reporting year two top-line data from the Company’s Phase 3 trial (CARDINAL) of bardoxolone methyl in patients with chronic kidney disease caused by Alport syndrome. A copy of the press release is attached as Exhibit 99.2 and incorporated herein by reference.
The Company plans to discuss these results on its previously announced conference call on November 9, 2020, at 8:00 a.m. EDT. Information about how to access the conference call is in the press release attached as Exhibit 99.1. The presentation slides that are to be used in connection with the conference call are attached as Exhibit 99.3 and incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information set forth under Item 7.01 and in Exhibits 99.1, 99.2, and 99.3, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth in such filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K and oral statements made with respect to information contained in this report may contain certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, our plans to submit regulatory filings, and our ability to obtain and retain regulatory approval of our product candidates. You can identify forward-looking statements because they contain words such as “believes,” “will,” “may,” “aims,” “plans,” “model,” and “expects.” Forward-looking statements are based on the Company’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the timing, costs, conduct, and outcome of our clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; (ii) the timing and likelihood of regulatory filings and approvals for our product candidates; (iii) whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; (iv) the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the market opportunities for our product candidates; and (v) other factors set forth in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K, under the caption “Risk Factors.” The forward-looking statements speak only as of the date made and, other than as required by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.