Vera Therapeutics Announces Q3 2024 Financials and Business Update

Vera Therapeutics, Inc., a biotechnology firm focused on creating transformative treatments for serious immunological diseases, recently disclosed significant advancements and financial outcomes for the third quarter ending September 30, 2024. The company is actively developing atacicept for patients with immunoglobulin A nephropathy (IgAN) and has reported encouraging results from its clinical trials.

In a notable update, 96-week data from the Phase 2b ORIGIN trial of atacicept in IgAN were presented at the American Society of Nephrology (ASN) Kidney Week 2024. This data, which was simultaneously published in the Journal of the American Society of Nephrology (JASN), showed positive results in stabilizing estimated glomerular filtration rate (eGFR) over a prolonged period, indicating atacicept's potential as a leading disease-modifying treatment.

Additionally, Vera completed the enrollment of the primary endpoint cohort in the pivotal Phase 3 ORIGIN 3 trial for atacicept in IgAN, with topline results expected in the second quarter of 2025. The company also announced the expansion of its atacicept development program to encompass a broader IgAN patient population and other autoimmune kidney diseases, such as membranous nephropathy (MN) and focal segmental glomerulosclerosis (FSGS). This expansion includes the upcoming PIONEER study, set to begin in 2025, which will evaluate atacicept's efficacy in wider IgAN populations and other related conditions.

Vera Therapeutics has successfully raised approximately $345 million through an equity offering, strengthening its financial position ahead of potential regulatory submissions and commercial launches. This influx of funds is expected to support the company through the anticipated approval and U.S. launch of atacicept.

During the third quarter, Vera appointed Matt Skelton as Executive Vice President, Commercial, and held an R&D Day in New York, where they outlined the expanded development plans for atacicept. Present were academic leaders including Drs. Jonathan Barratt, Richard Lafayette, and Brad Rovin, who discussed the potential and future applications of atacicept.

The ORIGIN 3 trial remains on schedule to deliver its topline results by Q2 2025, with a Biologics License Application (BLA) submission to the U.S. FDA planned for later that year. Vera is also preparing to initiate the ORIGIN Extend study in Q4 2024, which will offer participants extended access to atacicept and collect additional long-term safety and efficacy data.

Financially, Vera reported a net loss of $46.6 million for the quarter, compared to a net loss of $20.1 million in the same period the previous year. The company used $95.5 million in net cash for operating activities over the nine months ending September 30, 2024, up from $67.0 million during the same timeframe last year. As of September 30, 2024, Vera had $353.3 million in cash, cash equivalents, and marketable securities, further bolstered by the recent equity offering.

Atacicept is an investigational recombinant fusion protein designed to inhibit the activity of BAFF and APRIL, cytokines that encourage B-cell survival and autoantibody production linked to autoimmune diseases like IgAN and lupus nephritis. The ORIGIN Phase 2b trial demonstrated that atacicept significantly reduced proteinuria and stabilized eGFR compared to placebo over 36 weeks, with an acceptable safety profile. These benefits persisted through 96 weeks, suggesting atacicept's potential role in treating IgAN.

Moreover, atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, highlighting its potential to significantly improve clinical outcomes for patients.

Vera is also developing MAU868, a monoclonal antibody aimed at neutralizing BK virus (BKV) infections, which are a major cause of kidney transplant loss. MAU868 has shown promise in blocking BKV virions from attaching to host cells and is currently under exclusive worldwide development and commercialization by Vera, following a licensing agreement with Amplyx Pharmaceuticals, Inc.

In summary, Vera Therapeutics is making significant strides in developing atacicept for IgAN and other autoimmune kidney diseases, backed by strong clinical data and financial support. The company is poised to continue its progress with upcoming trial results and regulatory submissions in the near future.