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Reata Pharmaceuticals Inc (RETA) SEC Filing 10-Q Quarterly report for the period ending Saturday, June 30, 2018

Reata Pharmaceuticals Inc

CIK: 1358762 Ticker: RETA

Exhibit 99.1

 

 

REATA PHARMACEUTICALS, INC. ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND AN UPDATE ON DEVELOPMENT PROGRAMS

IRVING, Texas—August 8, 2018

—Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today provided an update on the Company's product development programs and announced financial results for the second quarter ended June 30, 2018.

Product Development Updates

Bardoxolone Methyl in Rare Forms of Chronic Kidney Disease

In July, we reported positive one-year results for the Phase 2 portion of CARDINAL, a study of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) due to Alport syndrome, and positive final results for the Phase 2 autosomal dominant polycystic kidney disease (ADPKD) cohort of PHOENIX.  In the Phase 2 portion of CARDINAL, bardoxolone produced a statistically significant improvement in estimated glomerular filtration rate (eGFR) of 10.4 mL/min/1.73 m2 (p<0.0001) after 48 weeks of treatment and 4.1 mL/min/1.73 m2 (p<0.05) at Week 52 after withdrawal of active drug for four weeks (the retained eGFR benefit).  Reata collected historical eGFR data for 22 out of the 25 Phase 2 study patients.  The historical eGFR data demonstrate that the Phase 2 study patients’ kidney function was declining at an average annual rate of 4.2 mL/min/1.73 m2 for three years prior to study entry.  The demonstration of a retained eGFR benefit in patients with Alport syndrome suggests that bardoxolone may delay or prevent kidney failure in these patients and that the Phase 3 portion of CARDINAL is conservatively powered with respect to the key secondary endpoint of retained eGFR benefit.  Enrollment in the Phase 3 portion of CARDINAL is proceeding as planned, and top-line data is expected to be available in the second half of 2019.

In May 2018, the European Commission granted Orphan Drug designation for bardoxolone for the treatment of Alport syndrome.  Bardoxolone previously received Orphan Drug designation for the treatment of Alport syndrome from the FDA.

In the Phase 2 ADPKD cohort of PHOENIX, bardoxolone produced a statistically and clinically significant, time-dependent increase in eGFR of 9.3 mL/min/1.73 m2 (p<0.0001) at Week 12, which was the primary endpoint of the study.  Reata collected historical eGFR data for 29 of the 31 Phase 2 study patients. The historical eGFR data demonstrate that these patients’ kidney function was declining at an average annual rate of 4.8 mL/min/1.73 m2 for three years prior to study entry.  In other forms of CKD, changes in eGFR at Week 12 produced by bardoxolone significantly correlated with eGFR change after one year of treatment, which suggests that long-term eGFR improvements and retained eGFR benefit observed in other forms of CKD may translate to patients with ADPKD.  Reata is currently developing plans to advance the ADPKD program into a pivotal Phase 3 trial.

Enrollment in the IgA nephropathy and type 1 diabetic CKD (T1D CKD) cohorts of PHOENIX was completed in the second quarter, and we expect full primary endpoint data from these cohorts to be available during the third quarter of

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The following information was filed by Reata Pharmaceuticals Inc (RETA) on Wednesday, August 8, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Ticker: RETA
CIK: 1358762
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-18-020473
Submitted to the SEC: Wed Aug 08 2018 4:11:49 PM EST
Accepted by the SEC: Wed Aug 08 2018
Period: Saturday, June 30, 2018
Industry: Pharmaceutical Preparations

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