Vera Therapeutics Advances Clinical Trials and Financials Amid Progress Toward Commercial Launch

Vera Therapeutics reported Q2 earnings with a net loss of $76.5 million, up from $33.7 million last year. Despite the loss, the company's financial outlook remains strong with $556.8 million in cash and a new $500 million credit facility. Vera highlighted progress in its clinical trials, including a 46% reduction in proteinuria in its ORIGIN 3 trial and plans to submit a Biologics License Application for its lead product candidate, atacicept, in Q4 2025.

Vera Therapeutics, Inc. (Nasdaq: VERA) reported its financial results for the second quarter ended June 30, 2025, with a net loss of $76.5 million, an increase from the $33.7 million loss reported in the same period last year [1]. Despite the loss, the company's financial position remains robust, with $556.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025. Vera has also secured a new credit facility of up to $500 million from Oxford Finance LLC, extending its cash runway well beyond the potential commercial launch of atacicept [1].

The company highlighted significant progress in its clinical trials, including the ORIGIN 3 trial, which reported a 46% reduction in proteinuria from baseline for participants treated with atacicept, as measured by 24-hour urine protein-to-creatinine ratio (UPCR). The trial also achieved its primary endpoint, with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p0.0001) [1]. These results, along with the favorable safety profile of atacicept, position Vera to submit a Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the fourth quarter of 2025, with an expected commercial launch in 2026 [1].

Vera also initiated the PIONEER trial to evaluate atacicept in expanded IgAN populations, including anti-PLA2R positive primary membranous nephropathy (pMN), anti-nephrin positive focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) patients [1]. The company anticipates presenting full primary endpoint results from the ORIGIN 3 trial at a medical congress in the fourth quarter of 2025 and expects initial results from the PIONEER Phase 2 basket trial in the same period [1].

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for patients with serious immunological diseases. The company's lead product candidate, atacicept, is an investigational recombinant fusion protein that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA Nephropathy (IgAN) and lupus nephritis [1]. Vera believes atacicept is positioned for best-in-class potential and has received FDA Breakthrough Therapy Designation for the treatment of IgAN [1].

References
[1] https://www.biospace.com/press-releases/vera-therapeutics-provides-business-update-and-reports-second-quarter-2025-financial-results