Vera Therapeutics Updates Business and Reports Q2 2024 Financials

Vera Therapeutics, Inc., a biotechnology company in the late stages of clinical development, has provided an update on its business activities and financial performance for the second quarter ending June 30, 2024. The company has made notable strides in advancing its lead product candidate, atacicept, aimed at treating serious immunological diseases, particularly IgA Nephropathy (IgAN).

A key highlight for Vera Therapeutics was receiving the FDA's Breakthrough Therapy Designation for atacicept in treating IgAN. This designation underscores the FDA's recognition of atacicept's potential to significantly improve treatment outcomes for patients with this condition. The designation was supported by data from the Phase 2b ORIGIN study, which were presented at the 61st European Renal Association Congress (ERA24). The study demonstrated that atacicept stabilized kidney function over 72 weeks and led to rapid reductions in hematuria, generating significant enthusiasm within the medical community.

Marshall Fordyce, M.D., the Founder and CEO of Vera Therapeutics, expressed optimism about atacicept's future, highlighting the upcoming presentation of the 96-week clinical data from the Phase 2b ORIGIN trial slated for the fourth quarter of 2024. Additionally, the company is on track to complete patient enrollment in the pivotal Phase 3 ORIGIN 3 trial by the third quarter of 2024, with topline data expected by the second quarter of 2025. These milestones are crucial as they will support the company's submission for regulatory approval, potentially making atacicept one of the first B-cell modulators approved for IgAN.

In the second quarter, Vera Therapeutics also saw significant organizational growth with the appointments of David L. Johnson as Chief Operating Officer and Amit Sharma, M.D. as Executive Vice President of Medical Affairs and Clinical Research. Furthermore, Christy J. Oliger joined the Board of Directors as an independent director, bringing additional expertise to the company's leadership team.

Financially, Vera Therapeutics reported a net loss of $33.7 million for the quarter, equating to a net loss of $0.62 per diluted share, compared to a net loss of $20.2 million, or $0.46 per diluted share, for the same period in the previous year. During the first half of 2024, the company used $58.6 million in net cash for operating activities, a significant increase from $44.1 million used in the same period last year. As of June 30, 2024, Vera Therapeutics had $384.4 million in cash, cash equivalents, and marketable securities, which the company believes will be sufficient to fund its operations through the approval and US commercial launch of atacicept, if approved.

Vera Therapeutics is committed to advancing treatments for serious immunological diseases, aiming to change the standard of care for patients. Its lead product candidate, atacicept, is a fusion protein that inhibits B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which are involved in the production of autoantibodies that contribute to autoimmune diseases like IgAN and lupus nephritis. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize the BK virus (BKV), a significant threat in kidney transplant settings. The company holds all global developmental and commercial rights to both atacicept and MAU868.

Overall, Vera Therapeutics is making significant progress in its clinical and organizational development, positioning itself to potentially bring transformative treatments to patients with serious immunological diseases.