[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) 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](index=1&type=section&id=Q2%202025%20and%20Recent%20Business%20Highlights) 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](index=3&type=chunk)[5](index=5&type=chunk) 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](index=6&type=chunk) - Initiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and other autoimmune glomerular diseases[5](index=5&type=chunk) [Anticipated Upcoming Milestones](index=2&type=section&id=Anticipated%20Upcoming%20Milestones) 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](index=10&type=chunk) - The pivotal ORIGIN 3 study is expected to be completed in **2027**[10](index=10&type=chunk) - 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](index=10&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) 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](index=8&type=chunk) [Product Pipeline and Corporate Overview](index=2&type=section&id=Product%20Pipeline%20and%20Corporate%20Overview) 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](index=2&type=section&id=About%20Atacicept) 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](index=9&type=chunk) - The drug has received FDA Breakthrough Therapy Designation for the treatment of IgAN, reflecting its potential to demonstrate substantial improvement over available therapies[12](index=12&type=chunk) [About Vera Therapeutics](index=3&type=section&id=About%20Vera%20Therapeutics) 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](index=13&type=chunk) - 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](index=13&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) 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](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=6&type=section&id=Condensed%20Balance%20Sheets) 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** |

Core Insights - Vera Therapeutics reported significant clinical results from the ORIGIN 3 trial for atacicept, showing potential as a first dual BAFF/APRIL inhibitor for IgA Nephropathy (IgAN) [2][6] - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA for accelerated approval in Q4 2025, with a potential commercial launch in 2026 [2][6] Business Highlights - The ORIGIN 3 trial demonstrated a 46% reduction in proteinuria for atacicept-treated participants, achieving a statistically significant 42% reduction compared to placebo [7] - The safety profile of atacicept appears favorable and comparable to placebo, with full enrollment in the ORIGIN 3 trial completed [7] - Vera initiated the PIONEER trial to evaluate atacicept in a broader IgAN patient cohort and other autoimmune glomerular diseases [6][7] Financial Results - For Q2 2025, Vera reported a net loss of $76.5 million, compared to a net loss of $33.7 million in Q2 2024, with a net loss per diluted share of $1.20 [5] - Net cash used in operating activities for the first half of 2025 was $109.2 million, up from $58.6 million in the same period last year [5] - As of June 30, 2025, Vera had $556.8 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through potential approval and commercial launch of atacicept [8] Anticipated Upcoming Milestones - BLA submission for atacicept expected in Q4 2025, with full primary endpoint results from the ORIGIN 3 trial to be presented at a medical congress in the same quarter [6][7] - Initial results from the PIONEER Phase 2 basket trial are also expected in Q4 2025, with the ORIGIN 3 study completion anticipated in 2027 [6][7]

Efficacy Results - Atacicept demonstrated long-term stabilization of eGFR (estimated glomerular filtration rate) in IgAN patients over 96 weeks[31] - Atacicept treatment resulted in a sustained 66% reduction in Gd-IgA1 levels[20] - There was a notable 52% reduction in proteinuria (UPCR) with atacicept treatment over the 96-week study period[20] - Atacicept led to a 75% resolution of hematuria in treated participants[20] - The annualized eGFR slope with atacicept was -0.6 mL/min/1.73 m2 per year, comparable to the general population without kidney disease[20] Safety Profile - Atacicept was generally well-tolerated over 96 weeks, with an adverse event profile consistent with the initial 36-week randomized period[27] - During the double-blind phase, 73% of participants in the atacicept group experienced treatment-emergent adverse events (TEAEs)[27] - In the open-label extension (OLE) phase, 77% of participants experienced TEAEs[27] - Serious TEAEs were reported in 2% of participants during the double-blind phase and 11% during the OLE phase[27] - Discontinuation due to TEAEs occurred in 1% of participants during the double-blind phase and 2% during the OLE phase[27]

Industry Overview - The biopharmaceuticals industry presents both exciting opportunities and significant risks for investors, with leading growth stocks often emerging from this sector due to substantial rallies following positive trial results or government drug approvals [1][2] - Many biopharma firms face constant threats of collapse due to insufficient revenue, making breakthrough developments critical for their survival [2] Investment Strategies - Investors can balance their risk tolerance by relying on Wall Street analysts who specialize in the healthcare sector, potentially identifying high-potential investments before they gain mainstream recognition [3] Company Highlights: Kymera Therapeutics - Kymera Therapeutics Inc. focuses on developing small-molecule therapeutics to selectively degrade disease-causing proteins, with positive Phase 1 trial results for its flagship drug KT-621, aimed at treating moderate to severe atopic dermatitis [4][6] - The stock forecast for Kymera indicates a 12-month price target of $59.82, representing a 25.65% upside from the current price of $47.61, with 17 out of 18 analysts rating it as a Buy [5][7] - Kymera benefits from a robust pipeline and a partnership with AI-powered biopharma developer Sanofi, along with substantial cash reserves expected to sustain operations through 2028 [7] Company Highlights: Vera Therapeutics - Vera Therapeutics Inc. specializes in treatments for immunological diseases, with its leading candidate atacicept recently completing a positive Phase 3 trial for IgAN, positioning the company for potential FDA approval and a commercial launch by 2026 [9][10] - The stock forecast for Vera suggests a 12-month price target of $65.00, indicating a 193.45% upside from the current price of $22.15, with 9 out of 10 analysts rating it as a Buy [10][12] Company Highlights: Rapport Therapeutics - Rapport Therapeutics Inc. develops medicines for neurological and psychiatric disorders, with its candidate RAP-219 showing positive trial data for refractory focal epilepsy and plans for trials in bipolar mania [13][14] - The stock forecast for Rapport indicates a 12-month price target of $32.67, representing a 191.41% upside from the current price of $11.21, with all four analysts rating it as a Buy [14][15]

Financial Data and Key Metrics Changes - The company announced positive phase three results for Atacicept in the autoimmune kidney condition IgA nephropathy, with a 46% reduction in proteinuria from baseline, compared to a 7% reduction in the placebo group, resulting in a 42% adjusted effect [7][10][11] - The company plans to file its Biologics License Application (BLA) in the fourth quarter of this year, with a potential commercial launch in mid-2026 [8][9] Business Line Data and Key Metrics Changes - Atacicept is the only program in phase two and phase three studied as a home self-administered dose, with plans to deliver an auto-injector at potential commercial launch [5][6] - The company has two-year GFR data from phase two trials, showing that patients preserved kidney function while on Atacicept [6][8] Market Data and Key Metrics Changes - In the US, there are approximately 160,000 patients with biopsy-proven IgA nephropathy, with about 80,000 meeting the criteria for high risk of disease progression, representing a potential $10 billion market [10][11] - The company is well-positioned to capture a substantial portion of this market with strong phase three data [11] Company Strategy and Development Direction - The company aims to shift the treatment of autoimmune diseases from immune suppression to immune modulation, preserving safety while providing efficacy [4] - The company is expanding its research into other autoimmune kidney diseases and plans to conduct a basket trial for various IgA-mediated diseases [56][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving priority review from the FDA due to the breakthrough designation already in hand [41][42] - The company is well-resourced with $590 million in cash and an expanded credit facility of up to $500 million, providing a total of $1 billion for commercialization and pipeline growth [62] Other Important Information - The company has been actively engaging with the nephrology community to raise awareness of Atacicept and its potential impact on treatment [40] - The management highlighted the importance of GFR as a key metric in discussions with payers, emphasizing the drug's potential to avoid costly dialysis [51] Q&A Session Summary Question: How representative is the trial population of typical IgA nephropathy patients? - The trial population was similar to the global burden of IgA nephropathy, with a mean age of about 39-40 years and significant proteinuria levels [13][14][15] Question: How does the use of concomitant therapies affect the trial results? - The use of concomitant therapies like SGLT2 inhibitors did not impact the primary endpoint of proteinuria reduction, indicating a high-risk population still in need of new treatments [17][18][19] Question: What are the key differences between the company's data and competitor data? - The company emphasized the importance of efficacy, safety, and patient convenience, noting that Atacicept is the only self-administered drug in its category [25][27] Question: What is the status of the PIONEER study? - The PIONEER study is exploring a broader range of patients with IgA-mediated diseases, aiming to provide insights across multiple populations [56][58] Question: How is the company preparing for commercialization? - The company has been preparing for commercialization for several years, with a focus on building a strong sales force and engaging with payers [42][44]

Company Overview - Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [3] - The company's mission is to advance treatments that target the source of immunological diseases to change the standard of care for patients [3] Product Candidates - Vera's lead product candidate is atacicept, a fusion protein administered as a subcutaneous injection once weekly, which blocks B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL) [3] - Atacicept is aimed at treating autoimmune diseases such as IgAN (Berger's disease) and lupus nephritis by reducing autoantibodies [3] - The company is also developing MAU868, a monoclonal antibody designed to neutralize BK virus (BKV) infection, which can have severe consequences in settings like kidney transplants [3] Licensing and Partnerships - Vera retains all global developmental and commercial rights to both atacicept and MAU868 [3] - The company holds an exclusive license agreement with Stanford University for a next-generation fusion protein targeting BAFF and APRIL, known as VT-109, which has wide therapeutic potential across B cell mediated diseases [3] Upcoming Events - The management team will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference from June 9 – 11, 2025 [1] - The fireside chat is scheduled for June 11, 2025, at 3:15 PM EDT, with a webcast available for 90 days [2]

Core Viewpoint - Vera Therapeutics has secured a new credit facility of up to $500 million to support its growth and development of treatments for serious immunological diseases, particularly focusing on the pivotal atacicept program for IgA nephropathy [1][2][3] Group 1: Credit Facility Details - The new credit facility replaces an existing $50 million facility and includes an initial funding of $75 million expected on June 4, 2025 [1] - The refinancing reduces interest expenses significantly, lowering the borrowing cost by 320 basis points, with a new interest rate of 1-month SOFR plus 4.95%, subject to a SOFR floor of 3.75% [5] - The facility provides an additional $450 million of discretionary incremental capacity available in five tranches, allowing Vera to draw funds based on specific milestones and approvals [5] Group 2: Strategic Implications - The new credit facility enhances Vera's financial flexibility, allowing for an extended interest-only period of up to 42 months and no principal payments required in 2026 [5] - The refinancing is expected to improve Vera's ability to manage its capital structure efficiently and support the commercial launch of atacicept [2][5] - Vera aims to submit a Biologics License Application (BLA) to the FDA in Q4 2025, with potential approval and commercial launch of atacicept in 2026 [2][3] Group 3: Company Overview - Vera Therapeutics is focused on developing transformative treatments for serious immunological diseases, with its lead product candidate being atacicept, which targets B-cell Activating Factor (BAFF) and APRIL [4] - The company holds an exclusive license agreement with Stanford University for a next-generation fusion protein, VT-109, aimed at treating B cell-mediated diseases [4][6] - Vera is also developing MAU868, a monoclonal antibody designed to neutralize BK virus infections, which can have severe consequences in kidney transplant settings [4][6]

Group 1 - Vera Therapeutics, Inc. experienced a share price increase of over 65% during pre-market trading following the release of ORIGIN Phase 3 trial data [1] - Participants treated with atacicept for immunoglobulin A nephropathy (IgAN) showed a 46% reduction in proteinuria from baseline, with a statistically significant 42% reduction compared to placebo at week 36 (p<0.0001) [1][2] - The safety profile of atacicept was favorable and comparable to that of the placebo [2] Group 2 - Vera plans to present the trial results to the FDA soon and will submit full results to the American Society of Nephrology Kidney Week [3] - The company is targeting a potential commercial launch of atacicept in 2026 [3] - The ongoing trial will continue to evaluate kidney function changes over two years, with completion expected in 2027 [4]

Summary of Vera Therapeutics (VERA) Conference Call Company Overview - **Company**: Vera Therapeutics (VERA) - **Focus**: Development of Atacucept for the treatment of IgA nephropathy (IgAN) and other autoimmune diseases - **Financial Position**: Pro forma cash of $590 million with 63.7 million shares outstanding [6][5][4] Key Industry and Company Insights Clinical Trial Results - **ORIGIN Phase III Trial**: Positive top-line results announced for Atacucept, showing a 46% reduction in urine protein-to-creatinine ratio (UPCR) at week 36, with a 42% reduction after placebo adjustment [20][5] - **Safety Profile**: Atacucept demonstrated a favorable safety profile with only one serious adverse event in the treatment group compared to 11 in the placebo group [21][22] - **Patient Demographics**: Average age of participants was around 40 years, with significant baseline kidney function loss (approximately 40%) [18][19] Market Opportunity - **Addressable Patient Population**: Approximately 90,000 patients in the U.S. with IgAN are immediately addressable [30] - **Expansion Plans**: Vera aims to expand Atacucept's application to moderate and lower-risk patients and other autoimmune kidney diseases [30][41] Commercial Strategy - **Commercial Team Development**: A strong commercial leadership team has been established, focusing on building a competitive share of voice in the nephrology market [29][30] - **Market Research Insights**: Awareness of Atacucept among nephrologists is high, with positive feedback on its dual BAF and APRIL inhibition mechanism [32][34] Future Directions - **Regulatory Pathway**: Plans to submit a Biologics License Application (BLA) to the FDA in Q4 of this year [25][43] - **PIONEER Trial**: Ongoing trial to assess Atacucept in additional cohorts, including adolescents and post-transplant patients [41][42] Additional Important Points - **Patient Impact**: IgAN patients face a high risk of end-stage kidney disease (ESKD), with mortality rates comparable to cancer over five years [7][8] - **Long-term Vision**: Vera aims to transform the treatment landscape for autoimmune diseases, moving beyond IgAN to other conditions driven by autoantibodies [40][41] - **Injection Site Reactions**: Approximately 24% of patients experienced injection site reactions, mostly mild, with no severe cases reported [90] Conclusion Vera Therapeutics is positioned strongly in the autoimmune disease treatment landscape, particularly with Atacucept for IgAN. The positive trial results, robust safety profile, and strategic commercial plans indicate significant potential for market capture and patient impact in the coming years.

Core Insights - Vera Therapeutics announced that the ORIGIN Phase 3 trial of atacicept for immunoglobulin A nephropathy (IgAN) met its primary endpoint, demonstrating significant efficacy in reducing proteinuria [1][7]. Efficacy Results - Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, measured by the 24-hour urine protein-to-creatinine ratio (UPCR), and a 42% reduction compared to placebo at week 36 (p<0.0001) [2][7]. - Other prespecified endpoints showed results consistent with or better than those observed in the ORIGIN Phase 2b trial [2][7]. Safety Profile - The safety profile of atacicept was favorable and comparable to that of the placebo [2][7]. Regulatory Plans - Vera plans to share these results with the FDA and intends to submit a Biologics License Application (BLA) for atacicept in IgAN in the fourth quarter of 2025, potentially allowing for US approval and commercial launch in 2026 [4][7]. Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study involving 431 adults with IgAN, with participants receiving either atacicept 150 mg or placebo [5][7]. - The trial continues to evaluate changes in kidney function over two years, with completion expected in 2027 [5][7]. Company Vision - Vera Therapeutics aims to advance the standard of care in IgAN and other autoimmune kidney diseases, aspiring to evolve kidney medicine practices [4][12].