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Vera Therapeutics (NasdaqGM:VERA) Update / Briefing Transcript
2025-11-06 22:30
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.
Vera Therapeutics (NasdaqGM:VERA) Earnings Call Presentation
2025-11-06 21:30
Atacicept Clinical Development & Regulatory Milestones - Vera Therapeutics anticipates a US market launch of atacicept for IgAN in 2026, pending FDA approval[8, 9] - Phase 3 ORIGIN trial of atacicept achieved its primary endpoint, demonstrating a statistically significant 42% reduction in proteinuria (UPCR) compared to placebo at week 36 (p<00001)[43] - In the ORIGIN 3 trial, atacicept showed a 67% reduction in Gd-IgA1 and an 81% resolution of hematuria compared to placebo[48] - Vera Therapeutics plans to submit a BLA for atacicept in Q4 2025[8] Financial Position - As of September 30, 2025, Vera Therapeutics has approximately $497 million in cash, cash equivalents, and marketable securities[11] - Vera Therapeutics has an additional $425 million in non-dilutive capital available through the Oxford Facility[12] IgAN Market & Atacicept Potential - Vera Therapeutics estimates the US IgAN prevalence to be approximately 004% of the US population, or about 160,000 patients[59] - Nephrologists ranked atacicept as the most desired IgAN pipeline agent, with 30% considering it the most desired and 73% ranking it in the top 3[62] Pipeline Expansion - Vera Therapeutics is conducting a Phase 2 PIONEER trial to evaluate atacicept in expanded IgAN populations and anti-PLA2R & anti-nephrin podocytopathies[81]
Vera Therapeutics Announces Positive ORIGIN Phase 3 Data for Atacicept in IgA Nephropathy Presented at ASN Kidney Week 2025 and Published in the New England Journal of Medicine
Globenewswire· 2025-11-06 14:51
Core Insights - Vera Therapeutics announced positive data from the ORIGIN Phase 3 trial of atacicept for IgA nephropathy, presented at ASN Kidney Week 2025 and published in NEJM [1][2] Efficacy Results - Participants treated with atacicept showed a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo at week 36, with statistical significance (p<0.0001) [2][7] - Secondary endpoints also improved, with Gd-IgA1 reduced by 68% and hematuria resolved in 81% of participants with baseline hematuria [2] Safety Profile - The safety profile of atacicept was favorable and comparable to placebo, with fewer serious adverse events reported (1 event in atacicept group vs. 11 in placebo group) [3][11] - No deaths occurred in either treatment group, indicating a strong safety record [3] Clinical Significance - ORIGIN 3 is the first Phase 3 trial of a B-cell modulator in IgAN to demonstrate clinical improvements in key disease markers [4] - The consistent benefits across various subgroups suggest that atacicept may modify the disease course by targeting underlying pathophysiology [4] Regulatory and Commercial Plans - Vera Therapeutics plans to submit a Biologics License Application (BLA) to the FDA for atacicept in IgAN, with potential approval and commercial launch expected in 2026 [5][7] - The ORIGIN 3 trial continues to evaluate long-term kidney function changes over two years, with results expected in 2027 [6][7] Company Overview - Vera Therapeutics is focused on developing treatments for serious immunological diseases, with atacicept as its lead product candidate targeting B-cell activity to reduce autoantibodies [14] - The company is also exploring atacicept's potential in other autoimmune kidney diseases and holds an exclusive license for a next-generation fusion protein targeting BAFF and APRIL [14]
Vera Therapeutics(VERA) - 2025 Q3 - Quarterly Report
2025-11-05 21:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Vera Therapeutics, Inc. 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, 2025 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 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorp ...
Vera Therapeutics(VERA) - 2025 Q3 - Quarterly Results
2025-11-05 13:00
Exhibit 99.1 Third Quarter 2025 and Recent Business Highlights • Atacicept IgA nephropathy (IgAN) ORIGIN 3 trial primary endpoint results selected as a featured late-breaking oral presentation during opening plenary session of American Society of Nephrology (ASN) Kidney Week 2025 • Biologics License Application (BLA) submission through the Accelerated Approval Program for atacicept for the treatment of IgAN to U.S. FDA expected in Q4; potential U.S. commercial launch of atacicept in 2026 • Actively enrollin ...
Vera Therapeutics Provides Business Update and Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-05 12:29
Core Insights - Vera Therapeutics is focused on developing transformative treatments for serious immunological diseases, with a significant emphasis on IgA nephropathy (IgAN) [1][14] - The company is preparing to submit a Biologics License Application (BLA) for atacicept to the FDA, supported by data from the ORIGIN 3 trial, which is a pivotal study for the treatment of IgAN [2][6] Business Highlights - For Q3 2025, Vera Therapeutics reported a net loss of $80.3 million, compared to a net loss of $46.6 million in Q3 2024, indicating a significant increase in losses year-over-year [5][18] - The company had $497.4 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund ongoing clinical trials [6][20] - Operating expenses for Q3 2025 totaled $83.9 million, up from $49.8 million in Q3 2024, driven by increased research and development costs [18] Upcoming Milestones - The primary endpoint results from the ORIGIN Phase 3 trial of atacicept will be presented at the ASN Kidney Week on November 6, 2025 [7] - The BLA submission for atacicept is expected in Q4 2025, with a potential U.S. commercial launch in 2026 [6][7] - Initial results from the PIONEER trial are anticipated in Q4 2025, with two-year data from the ORIGIN 3 trial expected in 2027 [7][12] Financial Overview - The net cash used in operating activities for the nine months ended September 30, 2025, was $171.1 million, compared to $95.5 million for the same period in 2024 [5] - The company reported a comprehensive loss of $79.9 million for Q3 2025, compared to $45.1 million in Q3 2024 [18] - The weighted-average shares used in computing net loss per share increased to approximately 63.8 million in Q3 2025 from 54.9 million in Q3 2024 [18]
Vera Therapeutics to Host an Investor Call and Webcast to Provide an ORIGIN 3 Update on November 6, 2025 at 4:30 pm ET
Globenewswire· 2025-10-22 12:00
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]
BofA Initiates Coverage of Vera Therapeutics (VERA) With a Buy Rating
Insider Monkey· 2025-10-21 03:08
Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] - A specific company is highlighted as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI technologies [3][7] Investment Landscape - Wall Street is investing hundreds of billions into AI, but there is a pressing concern regarding the energy supply needed to sustain this growth [2] - AI data centers consume energy equivalent to that of small cities, leading to a strain on global power grids and rising electricity prices [2][3] - The company in focus is positioned to capitalize on the surge in demand for electricity driven by AI advancements [3][6] Company Profile - The company is described as a "toll booth" operator in the AI energy boom, benefiting from the increasing need for energy infrastructure [4][5] - It is involved in the U.S. LNG exportation sector, which is expected to grow significantly under the current administration's energy policies [7] - The company is noted for its capability in executing large-scale engineering, procurement, and construction projects across various energy sectors, including nuclear energy [7][8] Financial Position - The company is completely debt-free and has a substantial cash reserve, amounting to nearly one-third of its market capitalization [8] - It is trading at a low valuation of less than 7 times earnings, making it an attractive investment opportunity compared to other energy and utility firms [10][11] Market Trends - The ongoing AI infrastructure supercycle, combined with the onshoring boom and a surge in U.S. LNG exports, positions the company favorably in the market [14] - The influx of talent into the AI sector is expected to drive continuous innovation and advancements, further solidifying the importance of energy infrastructure [12][13]
Vera Therapeutics Announces ORIGIN 3 Late-Breaking Abstract Selected as Featured Oral Presentation at Opening Plenary Session of ASN Kidney Week 2025
Globenewswire· 2025-10-17 13:12
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]
Stocks of possible M&A targets have been crushing the market. Goldman says these 6 are the most likely to get bought.
Yahoo Finance· 2025-09-30 17:15
Group 1 - Mergers and acquisitions (M&A) activity has increased significantly in 2025, with a 29% rise in deal value year-over-year and an 8% increase in the number of deals [3][4] - Electronic Arts is set to be taken private in the largest leveraged buyout ever, resulting in a stock price increase of over 20% in two days following the announcement [1] - Goldman Sachs predicts a further 15% growth in the number of M&A deals in 2026, driven by improving economic conditions and CEO confidence [4] Group 2 - A basket of potential M&A candidates has outperformed the S&P 1500 by seven percentage points since early September [2] - Goldman Sachs has identified six stocks with a 30% to 50% chance of being acquired in the next 12 months, highlighting their potential as M&A targets [3][4] - The identified stocks include companies from the health care sector, such as Insmed, Madrigal Pharmaceuticals, Krystal Biotech, Mineralys Therapeutics, and Vera Therapeutics, with varying market capitalizations and year-to-date total returns [5][6][7][8][9]