Aurinia Announces Positive AURORA Phase 3 Trial Results Demonstrating Voclosporin Superiority Over Standard of Care in Lupus Nephritis

- Voclosporin achieved statistically superior Renal Response rate (p < 0.001) and comparable safety profile versus standard of care - - Statistically significant results demonstrated in all pre-specified hierarchical secondary endpoints - - Aurinia plans to file an NDA submission to the FDA during the first half of 2020 - - Company to host conference call to discuss results at 8:30 a.m. ET on Thursday, December 5, 2019 - VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) and low-dose corticosteroids, in the treatment of lupus nephritis (“LN”). “This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death.” This global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001). Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin, which included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (“UPCR”) ≤ 0.5, and time to 50% reduction in UPCR. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior MMF use) favoring voclosporin. Measure Result Odds Ratio [95% CI] p-value Primary Endpoint Renal Response at 52 weeks Voclosporin 40.8% Control 22.5% 2.65 [1.64, 4.27] p < 0.001 Secondary Endpoints Renal Response at 24 weeks Voclosporin 32.4% Control 19.7% 2.23 [1.34, 3.72] p = 0.002 Partial Renal Response at 24 weeks Voclosporin 70.4% Control 50.0% 2.43 [1.56, 3.79] p < 0.001 Partial Renal Response at 52 weeks Voclosporin 69.8% Control 51.7% 2.26 [1.45, 3.51] p < 0.001 Time to UPCR ≤ 0.5 Voclosporin faster than Control 2.02 [1.51, 2.70] Hazard Ratio p < 0.001 Time to 50% reduction in UPCR Voclosporin faster than Control 2.05 [1.62, 2.60] Hazard Ratio p < 0.001

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