Core Insights - Vera Therapeutics has appointed Matt Skelton as Chief Commercial Officer to lead the commercial launch of atacicept for IgA nephropathy [1][2] - Atacicept is a promising investigational treatment that targets B-cell activation and has shown significant clinical efficacy in trials [3][4][6] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [10] - The company's lead product candidate, atacicept, is designed to block B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which are involved in autoimmune diseases [10] Leadership Appointment - Matt Skelton brings extensive experience in global commercialization, having previously scaled Seagen's commercial organization from one product to four approved products [2][10] - His leadership is expected to be critical in transitioning Vera Therapeutics into a commercial-stage company [2] Atacicept Clinical Program - The ORIGIN Phase 2b clinical trial of atacicept met its primary and key secondary endpoints, showing significant reductions in proteinuria and stabilization of eGFR [4] - The ongoing ORIGIN 3 Phase 3 trial has also met its primary endpoint with a statistically significant reduction in proteinuria at week 36 [5] Regulatory Status - Atacicept has received Breakthrough Therapy Designation from the FDA for IgA nephropathy, indicating its potential to significantly improve treatment outcomes [6] - The Biologics License Application (BLA) for atacicept has received Priority Review designation, with a target action date set for July 7, 2026 [7] Future Studies - The ORIGIN Extend study allows participants to access atacicept until its commercial availability and collects long-term safety and efficacy data [8] - Atacicept is also being evaluated in other autoimmune kidney diseases, expanding its potential therapeutic applications [8][10]

Summary of Vera Therapeutics FY Conference Call Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Founded**: 2016 in San Francisco - **Lead Product**: Atacicept, a first-in-class dual BAFF/APRIL inhibitor - **Financial Position**: Pro forma cash of $779 million with 71.3 million shares outstanding [4][5] Industry Context - **Primary Indication**: IgA nephropathy (IgAN), the most common primary glomerular disease worldwide, with an incidence of 2.5 per 100,000 people [6] - **Market Size**: Estimated 160,000 diagnosed IgAN patients in the U.S., with half in the highest-risk category [14] - **Competitive Landscape**: Five new drugs approved for IgAN in the past five years, indicating a growing market with premium pricing [16] Key Product Insights - **Atacicept Mechanism**: Targets BAFF and APRIL to modulate B-cell function, potentially avoiding immune suppression challenges [3][5] - **Clinical Trials**: - Phase III trial met primary endpoint with a 42% placebo-adjusted reduction in proteinuria at 36 weeks [11] - Secondary endpoints showed consistent results with phase II data [11] - Ongoing trials include PIONEER, studying Atacicept in moderate and low-risk patients [15] Regulatory and Commercialization Plans - **BLA Submission**: Submitted to the U.S. FDA with priority review status; PDUFA date set for July 7, 2026 [3][18] - **Commercial Launch**: Expected in July 2026, with a focus on educating nephrologists about Atacicept [13][21] - **Sales Force**: Hiring 82 sales representatives to target over half of the 11,000 nephrologists in the U.S. [23] Clinical Efficacy and Safety - **Efficacy Measures**: Aims to stabilize eGFR, reduce proteinuria, and resolve kidney inflammation [9][12] - **Safety Profile**: Atacicept showed a low rate of serious adverse events (0.5%) and was well tolerated [12] Future Opportunities - **Expansion Potential**: Atacicept has therapeutic potential in other autoimmune diseases, with an estimated addressable market of 1.2 million patients in the U.S. [17][18] - **Pipeline Development**: Ongoing studies for additional indications and formulations, including a monthly dosing option [29][31] Conclusion - **Transformative Year Ahead**: Vera Therapeutics is positioned for significant growth in 2026 with the anticipated launch of Atacicept and ongoing clinical trials [18][34]

BRISBANE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera Therapeutics”), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced that the Company’s management team will present at the 44th Annual J.P. Morgan Healthcare Conference, which is taking place in San Francisco, CA from January 12-15, 2026. The management team will also participate in one-on-one investor m ...

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].