Vera Therapeutics, Inc. (NASDAQ: VERA) has reported its financial results for the fourth quarter and full year ended December 31, 2024. The company's net loss for the year ended December 31, 2024, was $152.1 million, or a net loss per diluted share of $2.75, compared to a net loss of $96.0 million, or a net loss per diluted share of $2.25, for the year ended December 31, 2023.
During the year ended December 31, 2024, net cash used in operating activities was $134.7 million, compared to $92.2 million for the same period last year.
As of December 31, 2024, Vera reported $640.9 million in cash, cash equivalents, and marketable securities, which the company believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept.
Vera Therapeutics also provided a business update, highlighting several milestones, including the receipt of FDA breakthrough therapy designation for atacicept in IgA nephropathy (IgAN), the presentation of positive data showing eGFR stabilization over 96 weeks in the origin phase 2b clinical trial of atacicept in IgAN, and the initiation of the origin extend study.
Furthermore, the company announced the acquisition of exclusive rights for a novel, next-generation fusion protein targeting BAFF and APRIL, known as VT-109, and the completion of two equity financings in 2024, totaling approximately $593.2 million in net proceeds.
Vera Therapeutics also outlined major upcoming milestones, including updates from the ongoing pivotal origin 3 trial, the plan to submit a BLA to the U.S. FDA in the second half of 2025 for atacicept in IgAN for accelerated approval, assuming supportive data, and the initiation of the pioneer trial in 2025 to evaluate atacicept in expanded IgAN populations and anti-PLA2R positive PMN and anti-nephrin positive FSGS and MCD.
About Atacicept: Atacicept is an investigational recombinant fusion protein designed to target B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis.
The phase 2b origin clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Atacicept has received FDA breakthrough therapy designation for the treatment of IgAN.
Vera Therapeutics aims to advance treatments that target the source of immunological diseases to change the standard of care for patients. The company's lead product candidate, atacicept, is a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. The market has reacted to these announcements by moving the company's shares 4.3% to a price of $28.27. Check out the company's full 8-K submission here.
