Vera Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results

Core Insights - Vera Therapeutics reported significant clinical results from the ORIGIN 3 trial for atacicept, showing potential as a first dual BAFF/APRIL inhibitor for IgA Nephropathy (IgAN) [2][6] - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA for accelerated approval in Q4 2025, with a potential commercial launch in 2026 [2][6] Business Highlights - The ORIGIN 3 trial demonstrated a 46% reduction in proteinuria for atacicept-treated participants, achieving a statistically significant 42% reduction compared to placebo [7] - The safety profile of atacicept appears favorable and comparable to placebo, with full enrollment in the ORIGIN 3 trial completed [7] - Vera initiated the PIONEER trial to evaluate atacicept in a broader IgAN patient cohort and other autoimmune glomerular diseases [6][7] Financial Results - For Q2 2025, Vera reported a net loss of $76.5 million, compared to a net loss of $33.7 million in Q2 2024, with a net loss per diluted share of $1.20 [5] - Net cash used in operating activities for the first half of 2025 was $109.2 million, up from $58.6 million in the same period last year [5] - As of June 30, 2025, Vera had $556.8 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through potential approval and commercial launch of atacicept [8] Anticipated Upcoming Milestones - BLA submission for atacicept expected in Q4 2025, with full primary endpoint results from the ORIGIN 3 trial to be presented at a medical congress in the same quarter [6][7] - Initial results from the PIONEER Phase 2 basket trial are also expected in Q4 2025, with the ORIGIN 3 study completion anticipated in 2027 [6][7]