UNITED STATES SECURITIES AND EXCHANGE COMMISSION Vera Therapeutics, Inc. WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40407 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorp ...

Exhibit 99.1 Third Quarter 2025 and Recent Business Highlights • Atacicept IgA nephropathy (IgAN) ORIGIN 3 trial primary endpoint results selected as a featured late-breaking oral presentation during opening plenary session of American Society of Nephrology (ASN) Kidney Week 2025 • Biologics License Application (BLA) submission through the Accelerated Approval Program for atacicept for the treatment of IgAN to U.S. FDA expected in Q4; potential U.S. commercial launch of atacicept in 2026 • Actively enrollin ...

Core Insights - Vera Therapeutics is focused on developing transformative treatments for serious immunological diseases, with a significant emphasis on IgA nephropathy (IgAN) [1][14] - The company is preparing to submit a Biologics License Application (BLA) for atacicept to the FDA, supported by data from the ORIGIN 3 trial, which is a pivotal study for the treatment of IgAN [2][6] Business Highlights - For Q3 2025, Vera Therapeutics reported a net loss of $80.3 million, compared to a net loss of $46.6 million in Q3 2024, indicating a significant increase in losses year-over-year [5][18] - The company had $497.4 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund ongoing clinical trials [6][20] - Operating expenses for Q3 2025 totaled $83.9 million, up from $49.8 million in Q3 2024, driven by increased research and development costs [18] Upcoming Milestones - The primary endpoint results from the ORIGIN Phase 3 trial of atacicept will be presented at the ASN Kidney Week on November 6, 2025 [7] - The BLA submission for atacicept is expected in Q4 2025, with a potential U.S. commercial launch in 2026 [6][7] - Initial results from the PIONEER trial are anticipated in Q4 2025, with two-year data from the ORIGIN 3 trial expected in 2027 [7][12] Financial Overview - The net cash used in operating activities for the nine months ended September 30, 2025, was $171.1 million, compared to $95.5 million for the same period in 2024 [5] - The company reported a comprehensive loss of $79.9 million for Q3 2025, compared to $45.1 million in Q3 2024 [18] - The weighted-average shares used in computing net loss per share increased to approximately 63.8 million in Q3 2025 from 54.9 million in Q3 2024 [18]

Company Overview - Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [11] - The company's lead product candidate is atacicept, a fusion protein designed to block BAFF and APRIL, which are involved in B-cell activation and autoantibody production [11] Clinical Trials and Data - The ORIGIN Phase 3 clinical trial of atacicept for IgA nephropathy (IgAN) met its primary endpoint with a statistically significant reduction in proteinuria at week 36 [7] - The ORIGIN Phase 2b clinical trial also met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of eGFR compared to placebo [6] - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating potential substantial improvement over existing therapies [8] Expert Involvement - The investor call will feature Jonathan Barratt, MD, PhD, FRCP, and Richard Lafayette, MD, FACP, both of whom are prominent figures in renal medicine and have extensive experience in IgAN research [2][3][4] Future Developments - The ORIGIN Extend study allows participants to access atacicept until its potential commercial availability, while also gathering long-term safety and efficacy data [10] - Vera Therapeutics is exploring atacicept's efficacy in additional conditions, including anti-PLA2R positive primary membranous nephropathy and focal segmental glomerulosclerosis [10]

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] - A specific company is highlighted as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI technologies [3][7] Investment Landscape - Wall Street is investing hundreds of billions into AI, but there is a pressing concern regarding the energy supply needed to sustain this growth [2] - AI data centers consume energy equivalent to that of small cities, leading to a strain on global power grids and rising electricity prices [2][3] - The company in focus is positioned to capitalize on the surge in demand for electricity driven by AI advancements [3][6] Company Profile - The company is described as a "toll booth" operator in the AI energy boom, benefiting from the increasing need for energy infrastructure [4][5] - It is involved in the U.S. LNG exportation sector, which is expected to grow significantly under the current administration's energy policies [7] - The company is noted for its capability in executing large-scale engineering, procurement, and construction projects across various energy sectors, including nuclear energy [7][8] Financial Position - The company is completely debt-free and has a substantial cash reserve, amounting to nearly one-third of its market capitalization [8] - It is trading at a low valuation of less than 7 times earnings, making it an attractive investment opportunity compared to other energy and utility firms [10][11] Market Trends - The ongoing AI infrastructure supercycle, combined with the onshoring boom and a surge in U.S. LNG exports, positions the company favorably in the market [14] - The influx of talent into the AI sector is expected to drive continuous innovation and advancements, further solidifying the importance of energy infrastructure [12][13]

Core Insights - Vera Therapeutics, Inc. announced that data from the ORIGIN Phase 3 clinical trial of atacicept for IgA nephropathy will be presented at the ASN Kidney Week 2025 [1] - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating its potential for significant improvement over existing therapies [6] Clinical Trial Details - The ORIGIN Phase 3 trial achieved its primary endpoint with a statistically significant reduction in proteinuria at week 36 [5] - The ORIGIN Phase 2b trial demonstrated significant proteinuria reductions and stabilization of eGFR compared to placebo [4] - The ORIGIN Extend study allows participants to access atacicept until commercial availability, capturing long-term safety and efficacy data [7] Atacicept Overview - Atacicept is a recombinant fusion protein targeting B-cell survival and autoantibody production, relevant for IgAN and other autoimmune diseases [3] - The drug is administered as a subcutaneous injection once weekly [8] Company Background - Vera Therapeutics focuses on developing treatments for serious immunological diseases, with atacicept as its lead candidate [8] - The company holds exclusive rights to atacicept, VT-109, and MAU868, targeting various B-cell mediated diseases and BK virus infections [8]

Group 1 - Mergers and acquisitions (M&A) activity has increased significantly in 2025, with a 29% rise in deal value year-over-year and an 8% increase in the number of deals [3][4] - Electronic Arts is set to be taken private in the largest leveraged buyout ever, resulting in a stock price increase of over 20% in two days following the announcement [1] - Goldman Sachs predicts a further 15% growth in the number of M&A deals in 2026, driven by improving economic conditions and CEO confidence [4] Group 2 - A basket of potential M&A candidates has outperformed the S&P 1500 by seven percentage points since early September [2] - Goldman Sachs has identified six stocks with a 30% to 50% chance of being acquired in the next 12 months, highlighting their potential as M&A targets [3][4] - The identified stocks include companies from the health care sector, such as Insmed, Madrigal Pharmaceuticals, Krystal Biotech, Mineralys Therapeutics, and Vera Therapeutics, with varying market capitalizations and year-to-date total returns [5][6][7][8][9]

Core Insights - Goldman Sachs has identified six stocks with a high probability of being acquisition targets in the next year, with chances ranging from 30% to 50% [3][8] - The total dollar value of M&A deals has increased by 29% year-over-year, with deal volumes projected to rise by 8% in 2025 and an additional 15% increase expected in 2026 [2][4] Stock Highlights - **Insmed (NASDAQ:INSM)**: Health care sector, 102.50% year-to-date growth, 92nd percentile for Momentum [3] - **Madrigal Pharmaceuticals (NASDAQ:MDGL)**: Health care sector, 41.21% year-to-date growth, momentum rating of 89.62% [3] - **Krystal Biotech (NASDAQ:KRYS)**: Health care sector, 12.94% year-to-date growth, value score of 27.40% [3] - **Mineralys Therapeutics (NASDAQ:MNTA)**: Health care sector, 221.22% year-to-date growth, 97th percentile for momentum [3] - **TripAdvisor (NASDAQ:TRIP)**: Travel sector, 13.74% year-to-date growth, momentum rating of 68.47% [3] - **Vera Therapeutics (NASDAQ:VERA)**: Health care sector, 31.52% year-to-date decline, stronger short and medium-term price trend [3] Market Performance - The identified stocks have outperformed the S&P 1500 by seven percentage points since the start of September, coinciding with increased M&A activity [4] - The M&A landscape has been active in 2025, highlighted by Electronic Arts' $55 billion all-cash acquisition, which has positively impacted the stock prices of potential M&A targets [5]

Company Overview - Vera Therapeutics is a public biotech company based in San Francisco, founded by Marshall Fordyce, who serves as the CEO [4]. - The company has been operational for about 4 years and has made significant progress with its lead product candidate, atacicept, which is an immune modulator targeting B-cell-driven diseases [4]. Product Development - Vera Therapeutics recently completed a Phase III trial for atacicept, specifically addressing IgA Nephropathy, a major unmet medical need [4]. - The company plans to file for a Biologics License Application (BLA) in the fourth quarter of this year, with expectations to be on the market by mid-next year [4]. Market Potential - The management team believes that the kidney community is on the brink of a new era in managing patients with IgA Nephropathy and other related conditions [5].

Summary of Vera Therapeutics Conference Call Company Overview - **Company**: Vera Therapeutics (VERA) - **Industry**: Biotechnology, specifically focused on autoimmune kidney diseases - **Lead Product**: Atacicept, an immune modulator for B cell driven diseases, particularly IgA nephropathy Key Points and Arguments 1. **Product Development and Market Entry** - Vera Therapeutics plans to file for a Biologics License Application (BLA) in Q4 2025, with expectations to be on the market by mid-2026 [3][4][44] 2. **Unmet Medical Need** - There are approximately 160,000 patients in the U.S. with biopsy-proven IgA nephropathy, with at least half at high risk of disease progression [8][12] - Diagnosis is often delayed until around age 35, leading to urgent treatment needs as patients may require dialysis before age 50 if untreated [9][12] 3. **Clinical Trial Data** - Phase III trial showed a 46% reduction in proteinuria in the active group, significantly exceeding the FDA's 30% threshold for approval [22] - The GFR (glomerular filtration rate) data from the Phase II and interim Phase III trials indicate a potential to prevent the need for dialysis or transplant [25][27] 4. **Mechanism of Action** - Atacicept targets B cells, reducing the formation of immune complexes that lead to kidney inflammation and damage [16][17] - The drug is designed for self-administration via a low-volume auto-injector, enhancing patient convenience [43][57] 5. **Commercialization Strategy** - The company has been actively engaging with the nephrology community and has established a sales leadership team to prepare for the U.S. launch [50][51] - Early feedback indicates strong awareness and understanding of Atacicept among nephrologists [51] 6. **Regulatory Outlook** - The company is optimistic about receiving priority review from the FDA, based on the quality of their data and collaborative discussions with the agency [44][49] 7. **Pipeline and Future Studies** - Vera is exploring additional indications beyond IgA nephropathy, including membranous nephropathy and other autoimmune kidney diseases [59][60] - A study for monthly dosing of Atacicept is ongoing, with updates expected once the optimal dose is identified [55] Additional Important Information - **Patient Engagement** - Vera has been actively involved with patient advocacy groups, such as the IGAN Foundation, to better understand patient needs and improve treatment outcomes [53][54] - **Long-term Vision** - The company aims to transform the management of autoimmune kidney diseases and is focused on building a strong pipeline for future therapies [64] - **Acquisition** - Vera announced the acquisition of VT-109, a novel fusion protein, which is expected to complement their existing product offerings [56] This summary encapsulates the critical insights from the conference call, highlighting Vera Therapeutics' strategic direction, clinical advancements, and market potential in the biotechnology sector focused on kidney diseases.