Vera Therapeutics' TRUTAKNA meets all endpoints in Phase 3 ORIGIN trial for IgA nephropathy

Vera Therapeutics updated its corporate presentation to include the final efficacy analysis of the ORIGIN 3 trial. The updated presentation is furnished as Exhibit 99.2.

The annualized eGFR slope through 104 weeks showed a 5.0 mL/min/1.73m2/year treatment effect favoring TRUTAKNA, also with p<0.0001. This supports the durability of the treatment effect over two years.

The company announced that its drug TRUTAKNA met all prespecified endpoints in the final efficacy analysis of the ORIGIN 3 trial. This is the confirmatory trial supporting the drug's accelerated approval, and the results are intended to support a supplemental BLA for full approval.

At 52 weeks, TRUTAKNA patients showed essentially no decline in kidney function (mean eGFR change of -0.1 mL/min/1.73m2) versus a -5.7 decline for placebo, a treatment difference of 5.6 mL/min/1.73m2. The annualized eGFR slope through 104 weeks was -0.6 for TRUTAKNA versus -5.6 for placebo, a difference of 5.0 mL/min/1.73m2/year. These results align with the KDIGO treatment goal of reducing kidney function decline to the physiologic rate.

The company reported strong early commercial traction for TRUTAKNA, with over 350 patient start forms generated in the first ten weeks since launch. Management also noted that paid claims are being seen and initial payer policies are favorable.

Vera Therapeutics plans to submit a supplemental Biologics License Application to the FDA in the fourth quarter of 2026 seeking full approval for TRUTAKNA based on the ORIGIN 3 final efficacy results. The company stated it looks forward to potential full approval in 2027.

The corporate presentation discloses final Phase 3 ORIGIN efficacy results for TRUTAKNA (atacicept) in IgA nephropathy. The composite kidney disease progression endpoint showed a hazard ratio of 0.24 (95% CI 0.12, 0.48; p<0.0001), corresponding to a 76% risk reduction through 104 weeks. This is a highly material efficacy disclosure supporting the company's planned supplemental Biologics License Application (sBLA) for full approval.

The presentation discloses that TRUTAKNA stabilized eGFR compared to placebo through 104 weeks. The placebo-adjusted difference in mean eGFR change from baseline was 5.6 mL/min/1.73m² at 52 weeks, and the placebo-adjusted difference in annualized eGFR slope through 104 weeks was 5.0 mL/min/1.73m² per year. These results support the potential for comprehensive disease modification in IgA nephropathy.

The presentation states that Phase 3 final analysis results support an sBLA submission in Q4 2026. The company previously announced alignment with the FDA on a revised, earlier ORIGIN 3 eGFR analysis plan, with eGFR results expected in Q3 2026 and potential full approval in 2027. This timeline is a key regulatory catalyst for the company.

The presentation discloses that TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo. Serious adverse events occurred in 7% of TRUTAKNA patients versus 15% of placebo patients, and adverse events leading to drug discontinuation occurred in 2% versus 10%. No deaths occurred in the TRUTAKNA group.

The presentation discloses the company's financial position as of June 30, 2026, with approximately $499 million in cash, cash equivalents, and marketable securities. Additionally, $425 million in non-dilutive capital is available through the Oxford Facility, subject to satisfaction of certain conditions. This provides context on the company's runway to support the planned sBLA submission and potential launch.