Vera Therapeutics, Inc. has reported its business highlights and financial results for the second quarter ended June 30, 2025. The company is on track to submit a biologics license application (BLA) for accelerated approval of Atacicept to the U.S. FDA in Q4 2025, with a potential commercial launch in 2026. The company also announced positive primary endpoint results from the ongoing origin phase 3 trial and initiated the pioneer trial to investigate Atacicept in a broader IgA Nephropathy (IgAN) patient cohort and multiple autoimmune glomerular diseases.
In the second quarter of 2025, Vera reported a net loss of $76.5 million, or a net loss per diluted share of $1.20, compared to a net loss of $33.7 million, or a net loss per diluted share of $0.62, for the same period in 2024. During the six months ended June 30, 2025, net cash used in operating activities was $109.2 million, compared to $58.6 million for the same period last year. As of June 30, 2025, Vera reported $556.8 million in cash, cash equivalents, and marketable securities, combined with its undrawn debt facility, which the company believes to be sufficient to fund operations through potential approval and U.S. commercial launch of Atacicept and beyond.
Atacicept, the company's lead product candidate, is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor. Atacicept has shown promising results in the treatment of IgAN, with a 46% reduction from baseline in proteinuria for participants treated with Atacicept, as measured by 24-hour urine protein-to-creatinine ratio (UPCR). The safety profile of Atacicept across the origin program appears favorable and comparable to placebo.
The company's financial positioning has been strengthened with a new credit facility of up to $500 million of term loans with existing partner Oxford Finance LLC, extending the company’s cash runway well beyond potential commercial launch of Atacicept.
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. In addition to Atacicept, the company is also developing Mau868, a monoclonal antibody designed to neutralize infection with BK virus, and holds an exclusive license agreement with Stanford University for a novel, next-generation fusion protein targeting baff and april, known as Vt-109, with wide therapeutic potential across the spectrum of B cell-mediated diseases. Following these announcements, the company's shares moved -2.39%, and are now trading at a price of $20.45. Check out the company's full 8-K submission here.
