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

Core Insights - Vera Therapeutics is approaching a significant milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, which may lead to a Biologics License Application (BLA) submission to the FDA in the second half of 2025, potentially allowing for approval and commercial launch in 2026 [2][4][8] - The company reported a net loss of $51.7 million for Q1 2025, an increase from a net loss of $28.4 million in Q1 2024, with net cash used in operating activities rising to $54.4 million from $33.8 million year-over-year [4][5][15] - As of March 31, 2025, Vera had $589.8 million in cash, cash equivalents, and marketable securities, which is deemed sufficient to fund operations through the potential approval and U.S. commercial launch of atacicept [5][17] Business Highlights - The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of eGFR compared to placebo [7] - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating its potential to significantly improve treatment outcomes compared to existing therapies [10] - Vera is expanding the atacicept development program to include additional autoimmune kidney diseases such as primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) [8][11] Financial Results - For Q1 2025, total operating expenses were $57.2 million, up from $31.1 million in Q1 2024, with research and development expenses increasing to $41.3 million from $23.2 million [15] - The net loss per share for Q1 2025 was $0.81, compared to $0.56 for the same period in 2024 [15] - The company’s total assets as of March 31, 2025, were $610.2 million, down from $655.7 million at the end of 2024, with total liabilities at $75.2 million [17][18]