Vera Therapeutics(VERA) - 2025 Q2 - Quarterly Results

Business Update and Highlights Vera Therapeutics achieved significant clinical and corporate progress in Q2 2025, including positive ORIGIN 3 trial results for atacicept in IgAN, leading to a planned BLA submission in Q4 2025 and potential 2026 launch Q2 2025 and Recent Business Highlights Vera achieved a major clinical milestone in Q2 2025 with positive 36-week ORIGIN 3 trial data for atacicept in IgAN, showing a 42% UPCR reduction and leading to BLA preparation - 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, targeting a potential commercial launch in 2026[3][5] ORIGIN 3 Trial 36-Week Key Results | Metric | Result vs. Placebo | p-value | | :--- | :--- | :--- | | Primary Endpoint (UPCR Reduction) | 42% reduction | p<0.0001 | | Proteinuria Reduction (from baseline) | 46% reduction | N/A | - The safety profile of atacicept across the ORIGIN program was reported as favorable and comparable to placebo[6] - Initiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and other autoimmune glomerular diseases[5] Anticipated Upcoming Milestones Vera Therapeutics anticipates key milestones in late 2025, including BLA submission for atacicept, full ORIGIN 3 trial results, and initial PIONEER trial results, supported by a new $500 million credit facility - Key upcoming events for late 2025 include: * Submission of a BLA for atacicept in IgAN to the U.S. FDA in Q4 2025 * Presentation of full 36-week results from the pivotal ORIGIN 3 trial in Q4 2025 * Initial results from the PIONEER Phase 2 basket trial expected in Q4 2025[10] - The pivotal ORIGIN 3 study is expected to be completed in 2027[10] - The company secured a new credit facility of up to $500 million, extending its cash runway well beyond the potential commercial launch of atacicept[10] Financial Performance Vera Therapeutics reported a net loss of $76.5 million for Q2 2025 and increased cash usage, yet maintains a strong balance sheet with $556.8 million in cash, expected to fund operations through atacicept's potential U.S. launch Q2 2025 Financial Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $76,500 | $33,700 | | Net Loss per Diluted Share | $1.20 | $0.62 | Six Months Ended June 30 Cash Flow (in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $109,200 | $58,600 | - As of June 30, 2025, the company reported $556.8 million in cash, cash equivalents, and marketable securities[8] Product Pipeline and Corporate Overview Vera Therapeutics is a late-stage clinical biotechnology company focused on immunological diseases, with lead candidate atacicept targeting IgAN and a pipeline including MAU868 and VT-109 About Atacicept Atacicept is an investigational recombinant fusion protein targeting BAFF and APRIL, received FDA Breakthrough Therapy Designation for IgAN, and is positioned as a potential best-in-class therapy - Atacicept is an investigational recombinant fusion protein that binds to cytokines BAFF and APRIL, which promote B-cell survival and autoantibody production associated with certain autoimmune diseases[9] - The drug has received FDA Breakthrough Therapy Designation for the treatment of IgAN, reflecting its potential to demonstrate substantial improvement over available therapies[12] About Vera Therapeutics Vera Therapeutics is a late clinical-stage biotechnology company developing treatments for immunological diseases, with lead product atacicept and a pipeline including MAU868 and VT-109, retaining global rights - Vera's lead product candidate is atacicept, a self-administered subcutaneous injection that blocks both BAFF and APRIL[13] - The company is also developing MAU868, a monoclonal antibody to neutralize BK virus (BKV) infection, which can have severe consequences in settings like kidney transplants[13] Financial Statements The condensed financial statements show a significant increase in operating expenses, leading to a higher net loss for the second quarter and first half of 2025 compared to the prior year Condensed Statements of Operations and Comprehensive Loss Total operating expenses for Q2 2025 increased to $80.1 million, driven by doubled R&D, resulting in a net loss of $76.5 million compared to $33.7 million in Q2 2024 Condensed Statement of Operations (Three Months Ended June 30, in thousands) | | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $58,195 | $29,311 | | General and administrative | $21,946 | $8,032 | | Total operating expenses | $80,141 | $37,343 | | Net loss | $(76,531) | $(33,708) | Condensed Statement of Operations (Six Months Ended June 30, in thousands) | | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $99,473 | $52,511 | | General and administrative | $37,862 | $15,944 | | Total operating expenses | $137,335 | $68,455 | | Net loss | $(128,225) | $(62,091) | Condensed Balance Sheets As of June 30, 2025, total assets decreased to $578.5 million due to reduced cash and marketable securities, while total liabilities increased to $110.3 million, primarily from higher long-term debt Condensed Balance Sheet Highlights (in thousands) | | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and marketable securities | $556,827 | $640,852 | | Total assets | $578,528 | $655,681 | | Liabilities & Equity | | | | Long-term debt | $74,464 | $50,687 | | Total liabilities | $110,251 | $78,526 | | Total stockholders' equity | $468,277 | $577,155 |