BRISBANE, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. ("Vera"), a late clinicalstage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced the pricing of an underwritten public offering of 7,142,858 shares of its Class A common stock at a price to the public of $42.00 per share. The gross proceeds to Vera from the offering, before deducting underwriting discounts and commissions and esti ...

Summary of Vera Therapeutics Virtual Investor Event Company Overview - **Company**: Vera Therapeutics - **Lead Product**: Atacicept, a dual B cell modulator in Phase 3 for IgA nephropathy (IgAN) with potential applications in various autoimmune diseases [4][5][6] Industry Context - **Disease Focus**: IgA nephropathy (IgAN), an immune complex-mediated kidney disease leading to inflammation and kidney failure, particularly in young adults [10][29] - **Market Opportunity**: Estimated prevalence of IgAN in the US is around 160,000 patients, with potential to expand treatment to over 200,000 patients with autoimmune kidney diseases [8][5] Key Clinical Data - **Phase 2b Study Results**: Long-term data from the Origin Phase 2b study presented at the American Society of Nephrology's Kidney Week [2][10] - **Efficacy**: Atacicept demonstrated a significant reduction in immune complexes, proteinuria, and stabilization of kidney function (GFR) over 96 weeks [4][19][25] - **GFR Stabilization**: Annualized loss of kidney function was 0.6 mL/min/year, compared to an average of 6 mL/min/year in placebo-treated populations [20][21] - **Safety Profile**: Atacicept was well tolerated with over 90% retention rate in the open-label extension phase [24][50] Regulatory and Commercial Strategy - **FDA Designation**: Atacicept received breakthrough designation from the FDA, with plans for a BLA submission in the second half of 2025 and a projected commercial launch in 2026 [5][30] - **Intellectual Property**: Anticipated biologics exclusivity protection through 2038 in the US, with strategies to extend the lifecycle of Atacicept [6][8] Competitive Landscape - **Comparison with Other Treatments**: Atacicept's mechanism targets the production of pathogenic IgA, contrasting with traditional treatments like steroids and complement inhibitors that do not address the root cause of IgAN [40][59] - **Patient-Centric Approach**: Atacicept allows for at-home self-administration, enhancing patient compliance and quality of life compared to in-clinic treatments [33][65] Future Directions - **Expansion of Clinical Trials**: Initiation of two new studies (Origin Extend and PIONEER) to explore Atacicept's efficacy in broader populations and additional autoimmune diseases [30][72] - **Long-term Monitoring**: Ongoing assessment of safety, particularly regarding infection risks and potential hypogammaglobulinemia associated with long-term B cell modulation [90][91] Financial Position - **Cash Reserves**: Vera Therapeutics reported a strong financial position with approximately $3.38 billion in cash [8] Conclusion - **Transformative Potential**: Atacicept represents a significant advancement in the treatment of IgAN and potentially other autoimmune diseases, with promising clinical data supporting its efficacy and safety [26][25]

Clinical Trial Updates - Long-term results from the ORIGIN Phase 2b clinical trial of atacicept for IgAN treatment will be presented at ASN Kidney Week 2024, alongside two informational posters detailing the ORIGIN Phase 3 and ORIGIN Extend trials [1] - The ORIGIN Phase 2b trial met its primary and key secondary endpoints, showing statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR compared to placebo through 36 weeks [6] - Atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR through 72 weeks, reflecting a profile consistent with the general population without IgAN [6] Upcoming Events - An in-person and virtual R&D Day will be held in New York on October 2, 2024, featuring discussions on expanded atacicept R&D activities with key opinion leaders and the company's management team [3] - The ASN Kidney Week 2024 presentations include a late-breaking oral presentation on the ORIGIN Phase 2b study and two informational posters on the ORIGIN Phase 3 and ORIGIN Extend trials [1][2] Product and Pipeline Overview - Atacicept is a fusion protein that blocks BAFF and APRIL, targeting B cells and plasma cells to reduce autoantibodies in autoimmune diseases like IgAN and lupus nephritis [4][5] - The product has received FDA Breakthrough Therapy Designation for IgAN, reflecting its potential to demonstrate substantial improvement over available therapies [7] - Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize BK virus infection, particularly in kidney transplant settings [4] Company Background - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [4] - The company retains global developmental and commercial rights to atacicept and MAU868 [4]

Received FDA Breakthrough Therapy Designation for atacicept in IgA Nephropathy (IgAN) Presented data from Phase 2b ORIGIN study at ERA24 Congress showing atacicept stabilized kidney function through 72 weeks and led to rapid reductions in hematuria Topline 96-week data from Phase 2b ORIGIN study expected in Q4 2024 On track to complete enrollment in pivotal Phase 3 ORIGIN 3 trial for primary endpoint in Q3 2024; topline data expected in Q2 2025 BRISBANE, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Vera Therap ...

"We are delighted to welcome Christy to our Board during this important period in Vera's history. Her extensive experience and counsel will be a valuable resource for the executive team as we advance the development of atacicept for the treatment of IgAN and begin planning for atacicept's potential commercial launch," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. Ms. Oliger currently serves on multiple public company boards, including Karyopharm Therapeutics, Replimune Group, and LAVA T ...

Forward-looking Statements Statements contained in this press release regarding matters, events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera's plans to commercially launch atacicept and Vera's product candidates, strategy, and regulatory matters. Because such statements are subject to risks and uncertainties, actual res ...

About Vera Each stock option granted on June 4, 2024 has an exercise price per share equal to $39.47 per share, Vera's closing trading price on June 4, 2024. Each stock option will vest over four years, with 25% of the underlying shares vesting on the first anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee's continued service relationship with Vera through the applicable vesting dates. Each ...

BRISBANE, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. The designation reflects the FDA's determination that, based on an assessment of data from the Phase 2b ORIGI ...

BRISBANE, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN. The designation reflects the FDA's determination that, based on an assessment of data from the Phase 2b ORIGI ...

BRISBANE, Calif., May 25, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced data presentations from its Phase 2b ORIGIN trial of atacicept in immunoglobulin A nephropathy (IgAN), showing that atacicept stabilized kidney function through 72 weeks and led to rapid improvements in hematuria. These data were presented at ...