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 participate in the TD Cowen 45th Annual Health Care Conference from March 3 – 5, 2025, including a fireside chat and one-on-one investor meetings [1][2] Company Overview - Vera's mission is to advance treatments targeting the source of immunological diseases to change the standard of care for patients [3] - The lead product candidate, atacicept, is a fusion protein administered subcutaneously once weekly, designed to block B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are involved in autoimmune diseases like IgAN and lupus nephritis [3] - Vera is also developing MAU868, a monoclonal antibody aimed at neutralizing BK virus infections, particularly in kidney transplant settings [3] - The company retains all global developmental and commercial rights to both atacicept and MAU868, and has an exclusive license agreement with Stanford University for a next-generation fusion protein, VT-109, targeting BAFF and APRIL [3]

Core Insights - Vera Therapeutics is advancing its investigational therapy atacicept for autoimmune diseases, particularly IgA nephropathy, with significant upcoming milestones including the announcement of primary endpoint results from the ORIGIN Phase 3 study in Q2 2025 and plans for a Biologics License Application (BLA) submission in the second half of 2025 [2][6][11] Business Highlights - For the fiscal year 2024, Vera reported a net loss of $152.1 million, or $2.75 per diluted share, compared to a net loss of $96.0 million, or $2.25 per diluted share, in 2023 [5][16] - Operating expenses for 2024 totaled $167.2 million, with research and development expenses at $126.2 million and general and administrative expenses at $41.0 million [16] - The company ended 2024 with $640.9 million in cash, cash equivalents, and marketable securities, which is expected to support operations through potential approval and commercial launch of atacicept [8][17] Upcoming Milestones - The primary endpoint result from the atacicept pivotal Phase 3 ORIGIN trial in IgA nephropathy is expected to be announced in Q2 2025, with a BLA submission planned for the second half of 2025 [6][10] - The ORIGIN Extend study has been initiated to provide participants with extended access to atacicept and gather longer-term safety and efficacy data [7] - A new QM dose-finding study is set to begin in 2025, and the PIONEER trial will evaluate atacicept in expanded IgA nephropathy populations [6][10] Financial Overview - Net cash used in operating activities for 2024 was $134.7 million, an increase from $92.2 million in the previous year [8] - The company completed two equity financings in 2024, raising approximately $593.2 million in net proceeds to strengthen its balance sheet [7] - As of December 31, 2024, total assets were reported at $655.7 million, with total liabilities at $78.5 million, resulting in stockholders' equity of $577.2 million [17]

Financial Performance - Vera Therapeutics reported a net loss of $152.1 million for the year ended December 31, 2024, compared to a net loss of $96.0 million in 2023, representing a 58.8% increase in losses[8] - Operating expenses for 2024 totaled $167.2 million, up from $102.0 million in 2023, indicating a 63.9% increase year-over-year[18] - As of December 31, 2024, the total stockholders' equity increased to $577.2 million from $101.7 million in 2023, reflecting a significant growth in equity[20] Cash and Funding - The company had $640.9 million in cash, cash equivalents, and marketable securities as of December 31, 2024, sufficient to fund operations through potential approval and U.S. commercial launch of atacicept[9] - Vera completed two equity financings in 2024, raising approximately $593.2 million in net proceeds to bolster its balance sheet ahead of regulatory submission and commercial launch[11] Clinical Development - Vera is on track to announce the primary endpoint result from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy in Q2 2025, with a Biologics License Application submission planned for the second half of 2025[5] - The company received FDA Breakthrough Therapy Designation for atacicept in IgAN, reflecting its potential to significantly improve treatment outcomes[6] - The Phase 2b ORIGIN clinical trial of atacicept demonstrated statistically significant proteinuria reductions and stabilization of eGFR over 96 weeks[12] - Vera announced an expanded development pipeline for atacicept across multiple autoimmune kidney diseases, including PMN, FSGS, and MCD, beginning in 2025[6] - The company plans to initiate the PIONEER trial in 2025 to evaluate atacicept in expanded IgAN populations and other related conditions[11]

Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [2] - The company's mission is to advance treatments targeting the source of immunological diseases to change the standard of care for patients [2] - Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to autoimmune diseases like IgAN and lupus nephritis [2] - The company is also developing MAU868, a monoclonal antibody designed to neutralize BK virus (BKV) infection, particularly in kidney transplant settings [2] - Vera retains all global developmental and commercial rights to atacicept and MAU868 [2] Strategic Development - Vera announced an exclusive license agreement with Stanford University for VT-109, a novel next-generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across B cell mediated diseases [1] - This agreement is part of Vera's lifecycle management strategy to expand and extend its leadership position in B cell modulation [4] - The company plans to leverage its research, translational medicine, clinical development, and commercial expertise to advance VT-109 [4] - The agreement enables Vera to develop and market VT-109 in return for undisclosed upfront and milestone payments [4] Leadership Perspective - Marshall Fordyce, MD, Founder and CEO of Vera Therapeutics, emphasized the potential of VT-109 to transform the treatment of patients with B cell mediated diseases [4] - The transaction reflects Vera's commitment to improving outcomes for patients with severe autoimmune diseases [4]

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 targeting the source of immunological diseases to change the standard of care for patients [3] Product Pipeline - 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) infections, particularly in kidney transplant settings [3] - Vera retains all global developmental and commercial rights to both atacicept and MAU868 [3] Upcoming Events - The management team will present at the 43rd Annual J.P. Morgan Healthcare Conference from January 12 to 16, 2025, and will participate in one-on-one investor meetings [1] - The presentation is scheduled for January 13, 2025, at 4:30 PM PST, with a webcast available for viewing [2]

Core Viewpoint - Vera Therapeutics, Inc. (VERA) has seen a 12.6% increase in share price over the past four weeks, closing at $48.09, with a potential upside of 27.3% based on Wall Street analysts' mean price target of $61.20 [1] Price Targets and Estimates - The mean estimate consists of 10 short-term price targets with a standard deviation of $23.03, indicating variability among analysts; the lowest estimate suggests a 48% decline to $25, while the highest predicts a 122.5% increase to $107 [2] - Analysts' price targets can be misleading, as empirical research shows they rarely indicate actual stock price movements [5] - A low standard deviation in price targets suggests a high degree of agreement among analysts regarding the stock's price direction, serving as a starting point for further research [7] Earnings Estimates - Analysts have shown increasing optimism about VERA's earnings prospects, with a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has risen by 0.7% over the past month, with one estimate increasing and no negative revisions [10] - VERA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating potential upside [11]

BRISBANE, Calif., Nov. 08, 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 Company’s management team will present and participate in one-on-one meetings at upcoming investor conferences. Investor Conference Details: Guggenheim Securities Healthcare Innovation ConferenceFormat: Fireside Chat and 1x1sWebcast ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 2024 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 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-2744449 (State or other ju ...

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]