Company: VERA
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029969
Chunk: 177

Company: Vera Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 177
---
 records in clinical and commercial development who have led or been involved in the approvals of more than 15 medicines from leading companies, including Gilead Sciences and Amgen. We leverage our team’s know-how with additional outsourced resources and enable focused clinical development of our product candidates with the goal of improving patients’ lives.

These principles have guided us to the successful in-licensing of atacicept from Ares, VT-109 from Stanford University, and obtaining the rights to MAU868 from Pfizer, in each case with worldwide rights for development and commercialization. We take a gated-capital raise approach and scale product candidate investment and exposure in close step with key development milestones to ensure high return on development costs. 

The near- and long-term objectives to achieve our goal include:

•Complete global development of atacicept in IgAN. We reported positive 96-week results from the open label extension of the ORIGIN Phase 2b clinical trial in October 2024. We completed enrollment for the primary endpoint cohort of our global pivotal Phase 3 clinical trial in September 2024 and full enrollment is projected in Q2 2025. We anticipate primary endpoint results in the second quarter of 2025. If positive, we expect to submit a biologics license application (BLA) for atacicept in IgAN to the FDA in the second half of 2025. We have also committed to providing access to atacicept for all global ORIGIN participants until atacicept is available in their region through the ORIGIN EXTEND study. The PIONEER study will evaluate atacicept in an expanded IgAN population beyond the ORIGIN program. We anticipate clinical results from the ORIGIN EXTEND and PIONEER studies in 2025 and 2026.

•Build and scale organizational capabilities to support commercialization of atacicept. Under the leadership of our experienced management team, we are building a specialized commercial organization with deep launch experience in 

3

nephrology, B cell, and autoimmune therapeutics, to launch atacicept in the United States and other key markets, if approved. During 2024, we hired a Chief Commercial Officer and Executive Vice President, Commercial, to lead this organization.

•Explore additional disease areas where atacicept holds significant therapeutic promise. By targeting BAFF and APRIL, atacicept’s ability to reduce disease-causing autoantibodies may provide clinical benefit. We intend to explore additional immun