Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Files An 8-K Other EventsItem 8.01.Other Events.
On November 3, 2017, Reata Pharmaceuticals, Inc. (the “Company”) issued a press release announcing primary 12-week data from the Phase 2 portion of the CARDINAL trial studying bardoxolone methyl for the treatment of chronic kidney disease caused by Alport Syndrome. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference. The complete data are being presented by Geoffrey A. Block, M.D., CCRI, director of clinical research at Denver Nephrology, on November 3, 2017, at 10 a.m. CT at the American Society of Nephrology Kidney Week 2017 Annual meeting. The results from the Phase 2 portion of the CARDINAL trial are attached as Exhibit 99.2 and incorporated herein by reference.
The Company plans to hold a conference call on November 6, 2017, at 8:30 a.m. ET to review the results of CARDINAL and discuss the Company’s PHOENIX program for studying bardoxolone methyl in other rare forms of chronic kidney disease. Management’s presentation will be accessible via webcast and via teleconference as set forth in the attached press release.
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 forward looking information within the meaning of the Private Securities Litigation Reform Act of 1995. You may identify forward-looking statements by the use of words such as “believe,” “expect,” “plan,” “intend,” “anticipate,” “estimate,” “predict,” “potential,” “may,” “should,” “will” or other words or expressions of similar meaning, although not all forward-looking statements contain such terms. These forward-looking statements include, but are not limited to, statements about the CARDINAL trial and the PHOENIX PROGRAM.
Forward-looking statements are subject to risks and uncertainties, both known and unknown, that could cause actual results to differ materially from those expressed or implied in forward-looking statements. Such risks and uncertainties include, but are not limited to: our expectations regarding the timing, costs, conduct, and outcome of our clinical trials, including statements regarding the timing of the initiation and availability of data from such trials; the timing and likelihood of regulatory filings and approvals for our product candidates; our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the potential market opportunities for commercializing our product candidates; our expectations related to the use of our available cash; estimates of our expenses, future revenue, capital requirements, and our needs for additional financing; our ability to develop, acquire, and advance product candidates into, and successfully complete, clinical trials; the initiation, timing, progress, and results of future preclinical studies and clinical trials, and our research and development programs; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates; our ability to maintain and establish collaborations or obtain additional funding; our ability to maintain and establish relationships with third parties, such as contract research organizations, suppliers, and distributors; our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; our ability to establish and maintain arrangements for manufacture of our product candidates; the impact of governmental laws and regulations; developments and projections relating to our competitors and our industry; and other risks and uncertainties included in our most recent report on Form 10-K and subsequent reports on Forms 10-Q and 8-K available on the Investor & News section of www.reatapharma.com. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made, are not guarantees of future performance or results, and are subject to risks, uncertainties, and assumptions that are difficult to predict or quantify.The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as may be required by law.
Item 8.01.Financial Statements and Exhibits.
(d)Exhibits
REATA PHARMACEUTICALS INC ExhibitEX-99.1 2 reta-ex991_11.htm EX-99.1_PR_P2DATA_CARDINAL reta-ex991_11.htm Exhibit 99.1 Reata announces PRIMARY results from the phase 2 cardinal study of bardoxolone in alport syndrome at the American Society of Nephrology Kidney Week 2017 Annual Meeting met Primary endpoint of change in egfr at 12 weeks (p<0.000000001) 73% of patients had improvement in stage of CKD bardoxolone was well tolerated without any safety concerns Conference Call with management scheduled Monday,…To view the full exhibit click here
About Reata Pharmaceuticals, Inc. (NASDAQ:RETA)
Reata Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on identifying, developing and commercializing product candidates that modulate the activity of regulatory proteins involved in the biology of mitochondrial function, oxidative stress, and inflammation to address the unmet medical needs of patients with a range of serious or life-threatening diseases. The Company’s lead product candidates include bardoxolone methyl, which is being studied in Phase III trial for the treatment of pulmonary arterial hypertension (PAH), associated with connective tissue disease (CTD-PAH), as well as a Phase II trial for the treatment of pulmonary hypertension due to interstitial lung disease (PH-ILD), and PAH, each of which are subsets of pulmonary hypertension (PH), Omaveloxolone, which is in Phase II clinical development for the treatment of multiple diseases, including Friedreich’s ataxia, mitochondrial myopathies and metastatic melanoma.
