Core Insights - Vera Therapeutics has appointed James R. Meyers to its Board of Directors, bringing over three decades of biopharmaceutical commercial leadership experience [1][2] - The company is preparing to launch atacicept, a dual BAFF/APRIL inhibitor, aimed at transforming the treatment of IgA nephropathy and other autoimmune diseases [2][3] - Meyers' expertise in commercial operations and market access is expected to support the anticipated launch and growth of atacicept [2][3] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [3] - The lead product candidate, atacicept, is a fusion protein administered as a subcutaneous injection that targets BAFF and APRIL, which are involved in the production of autoantibodies [3] - The company also holds an exclusive license for VT-109, a next-generation fusion protein, and is developing MAU868, a monoclonal antibody for BK virus infection in kidney transplant recipients [3] Leadership Background - James R. Meyers previously served as Executive Vice President at Gilead Sciences, where he was instrumental in launching successful products in HIV and HCV, contributing to Gilead's revenue of over $28 billion in 2024 [2][3] - Meyers has held various leadership roles in the biopharmaceutical industry, including positions at AstraZeneca and IntraBio Ltd [2]

Core Insights - Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [3] - The company will present at the TD Cowen Immunology & Inflammation Summit on November 13, 2025, and participate in one-on-one investor meetings [1][2] Company Overview - Vera Therapeutics' mission is to advance treatments targeting the source of disease to change the standard of care for patients [3] - The lead product candidate, atacicept, is a fusion protein administered at home as a subcutaneous injection, designed to block BAFF and APRIL, which are involved in autoimmune diseases like IgAN and lupus nephritis [3] - The company is also evaluating atacicept for additional diseases where reducing autoantibodies may be clinically meaningful [3] - Vera Therapeutics holds an exclusive license for VT-109, a next-generation fusion protein targeting BAFF and APRIL, with potential across various B-cell-mediated diseases [3] - Additionally, the company is developing MAU868, a monoclonal antibody aimed at neutralizing BK virus infections, particularly in kidney transplant recipients [3] - Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868 [3]

Summary of Vera Therapeutics Investor Call - November 06, 2025 Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Focus**: Development of atacicept, a dual-BAFF APRIL inhibitor for autoimmune diseases, particularly IgA nephropathy Key Industry Insights - **IgA Nephropathy**: Most common primary glomerular disease globally, with an estimated incidence of 2.5 cases per 100,000 individuals [9] - **Patient Demographics**: Average age of patients with IgA nephropathy is around 35 years, with a significant risk of rapid kidney function decline leading to end-stage kidney disease (ESKD) before age 50 [6][7] - **Mortality Rate**: Mortality over five years from ESKD is comparable to cancer [8] Core Findings from ORIGIN Phase III Trial - **Atacicept Efficacy**: - Achieved a 46% reduction in proteinuria at 36 weeks compared to a 7% reduction in placebo [17] - 68% reduction in galactose-deficient IgA1 levels [18] - 80% resolution of hematuria in patients with blood in urine at baseline [18] - **Safety Profile**: Adverse events were balanced between atacicept and placebo groups, with no significant hypogammaglobulinemia reported [19][47] Financial Position - **Cash Position**: Pro forma cash of $497 million with access to an additional $425 million in non-dilutive capital [5] - **Share Count**: 63.9 million shares outstanding [5] Market Opportunity - **Patient Population**: Approximately 160,000 patients in the U.S. with 90,000 addressable in the phase III population [23] - **Commercial Strategy**: Sales leadership team in place, with plans to build out the sales force ahead of anticipated approval [22] Pipeline and Future Directions - **Expansion Plans**: Ongoing trials (EXTEND and PIONEER) to explore additional indications in autoimmune kidney diseases [5][27] - **Long-term Vision**: Potential to impact other autoimmune diseases beyond kidney medicine [29] Competitive Landscape - **Market Positioning**: Atacicept is viewed favorably among nephrologists, with strong preference indicated in market research [24] - **Pricing Strategy**: Anticipated premium pricing due to innovative profile and strong clinical data [25] Additional Insights - **Combination Therapy**: Discussion on the potential for atacicept to be used in combination with existing therapies like ACE inhibitors and SGLT2 inhibitors [34][36] - **Quality of Life**: Importance of stabilizing kidney function to improve patient mental health and quality of life [46] Conclusion - Vera Therapeutics is positioned for a significant impact in the treatment of IgA nephropathy with atacicept, supported by strong clinical data and a robust financial position, while also exploring broader applications in autoimmune diseases. The company is gearing up for a potential commercial launch in mid-2026, with a focus on capturing a meaningful share of the market.

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 - 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]

Core Insights - Vera Therapeutics, Inc. granted inducement awards to eight new employees, including non-qualified stock options for 99,000 shares and restricted stock units (RSUs) for 48,200 shares under the 2024 Inducement Plan [1][2] Group 1: Inducement Awards - The stock options have an exercise price of $20.45, which is the closing trading price on August 4, 2025 [2] - Stock options will vest over four years, with 25% vesting on the first anniversary and the remaining shares vesting monthly over the next 36 months [2] - RSUs will also vest over four years, with 25% vesting on each anniversary of August 20, 2025 [2] Group 2: Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on treatments for serious immunological diseases [3] - The lead product candidate, atacicept, is designed to block BAFF and APRIL, which are involved in autoimmune diseases like immunoglobulin A nephropathy and lupus nephritis [3] - Vera is also developing MAU868, a monoclonal antibody targeting BK virus infections, and holds global rights to atacicept and MAU868 [3]

Core Viewpoint - Vera Therapeutics reported a widening net loss of $76.5 million for Q2 2025, significantly exceeding analyst expectations, while also achieving revenue of $76.5 million, indicating increased spending as the company approaches regulatory filing for its lead drug candidate [1][5][6]. Financial Performance - The GAAP net loss increased by approximately 127% year-over-year, from $33.7 million in Q2 2024 to $76.5 million in Q2 2025 [2][5]. - The loss per share (GAAP) was $1.20, a significant increase from $0.62 in Q2 2024, reflecting a rapid rise in spending [6]. - Research and development expenses nearly doubled to $58.2 million from $29.3 million in Q2 2024, driven by costs associated with late-stage clinical trials and preparations for commercialization [2][6]. Business Overview - Vera Therapeutics is focused on developing therapies for serious immunological diseases, particularly Immunoglobulin A Nephropathy (IgAN), with its lead drug candidate, atacicept, designed to modify the disease course [3][9]. - The company is preparing for a pivotal Phase 3 ORIGIN trial outcome, which is crucial for a future submission to the FDA for accelerated approval [4][9]. Clinical Developments - Positive results from the ORIGIN Phase 3 trial showed a 46% reduction in proteinuria at 36 weeks, with a favorable safety profile for atacicept, reinforcing plans for a Biologics License Application (BLA) submission in Q4 2025 [7][9]. - Vera has initiated the PIONEER study to test atacicept in other kidney diseases, indicating ambitions to expand the drug's impact and revenue potential [8][12]. Strategic Initiatives - The company is building a specialized commercial team with nephrology expertise to facilitate the transition from clinical success to market adoption [10]. - Vera secured a new credit facility of up to $500 million, alongside $556.8 million in cash and equivalents, to support operations through the anticipated approval and launch of atacicept [11]. Future Outlook - Management emphasized near-term milestones, including the planned BLA submission for atacicept and expected initial results from the PIONEER trial later in the year [13][14]. - The company does not currently pay a dividend, focusing resources on advancing its clinical and commercial strategies [14].

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]

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]