Financial Data and Key Metrics Changes - The company announced positive phase three results for Atacicept in the autoimmune kidney condition IgA nephropathy, with a 46% reduction in proteinuria from baseline, compared to a 7% reduction in the placebo group, resulting in a 42% adjusted effect [7][10][11] - The company plans to file its Biologics License Application (BLA) in the fourth quarter of this year, with a potential commercial launch in mid-2026 [8][9] Business Line Data and Key Metrics Changes - Atacicept is the only program in phase two and phase three studied as a home self-administered dose, with plans to deliver an auto-injector at potential commercial launch [5][6] - The company has two-year GFR data from phase two trials, showing that patients preserved kidney function while on Atacicept [6][8] Market Data and Key Metrics Changes - In the US, there are approximately 160,000 patients with biopsy-proven IgA nephropathy, with about 80,000 meeting the criteria for high risk of disease progression, representing a potential $10 billion market [10][11] - The company is well-positioned to capture a substantial portion of this market with strong phase three data [11] Company Strategy and Development Direction - The company aims to shift the treatment of autoimmune diseases from immune suppression to immune modulation, preserving safety while providing efficacy [4] - The company is expanding its research into other autoimmune kidney diseases and plans to conduct a basket trial for various IgA-mediated diseases [56][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving priority review from the FDA due to the breakthrough designation already in hand [41][42] - The company is well-resourced with $590 million in cash and an expanded credit facility of up to $500 million, providing a total of $1 billion for commercialization and pipeline growth [62] Other Important Information - The company has been actively engaging with the nephrology community to raise awareness of Atacicept and its potential impact on treatment [40] - The management highlighted the importance of GFR as a key metric in discussions with payers, emphasizing the drug's potential to avoid costly dialysis [51] Q&A Session Summary Question: How representative is the trial population of typical IgA nephropathy patients? - The trial population was similar to the global burden of IgA nephropathy, with a mean age of about 39-40 years and significant proteinuria levels [13][14][15] Question: How does the use of concomitant therapies affect the trial results? - The use of concomitant therapies like SGLT2 inhibitors did not impact the primary endpoint of proteinuria reduction, indicating a high-risk population still in need of new treatments [17][18][19] Question: What are the key differences between the company's data and competitor data? - The company emphasized the importance of efficacy, safety, and patient convenience, noting that Atacicept is the only self-administered drug in its category [25][27] Question: What is the status of the PIONEER study? - The PIONEER study is exploring a broader range of patients with IgA-mediated diseases, aiming to provide insights across multiple populations [56][58] Question: How is the company preparing for commercialization? - The company has been preparing for commercialization for several years, with a focus on building a strong sales force and engaging with payers [42][44]

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]

Group 1 - Vera Therapeutics, Inc. experienced a share price increase of over 65% during pre-market trading following the release of ORIGIN Phase 3 trial data [1] - Participants treated with atacicept for immunoglobulin A nephropathy (IgAN) showed a 46% reduction in proteinuria from baseline, with a statistically significant 42% reduction compared to placebo at week 36 (p<0.0001) [1][2] - The safety profile of atacicept was favorable and comparable to that of the placebo [2] Group 2 - Vera plans to present the trial results to the FDA soon and will submit full results to the American Society of Nephrology Kidney Week [3] - The company is targeting a potential commercial launch of atacicept in 2026 [3] - The ongoing trial will continue to evaluate kidney function changes over two years, with completion expected in 2027 [4]

Summary of Vera Therapeutics (VERA) Conference Call Company Overview - **Company**: Vera Therapeutics (VERA) - **Focus**: Development of Atacucept for the treatment of IgA nephropathy (IgAN) and other autoimmune diseases - **Financial Position**: Pro forma cash of $590 million with 63.7 million shares outstanding [6][5][4] Key Industry and Company Insights Clinical Trial Results - **ORIGIN Phase III Trial**: Positive top-line results announced for Atacucept, showing a 46% reduction in urine protein-to-creatinine ratio (UPCR) at week 36, with a 42% reduction after placebo adjustment [20][5] - **Safety Profile**: Atacucept demonstrated a favorable safety profile with only one serious adverse event in the treatment group compared to 11 in the placebo group [21][22] - **Patient Demographics**: Average age of participants was around 40 years, with significant baseline kidney function loss (approximately 40%) [18][19] Market Opportunity - **Addressable Patient Population**: Approximately 90,000 patients in the U.S. with IgAN are immediately addressable [30] - **Expansion Plans**: Vera aims to expand Atacucept's application to moderate and lower-risk patients and other autoimmune kidney diseases [30][41] Commercial Strategy - **Commercial Team Development**: A strong commercial leadership team has been established, focusing on building a competitive share of voice in the nephrology market [29][30] - **Market Research Insights**: Awareness of Atacucept among nephrologists is high, with positive feedback on its dual BAF and APRIL inhibition mechanism [32][34] Future Directions - **Regulatory Pathway**: Plans to submit a Biologics License Application (BLA) to the FDA in Q4 of this year [25][43] - **PIONEER Trial**: Ongoing trial to assess Atacucept in additional cohorts, including adolescents and post-transplant patients [41][42] Additional Important Points - **Patient Impact**: IgAN patients face a high risk of end-stage kidney disease (ESKD), with mortality rates comparable to cancer over five years [7][8] - **Long-term Vision**: Vera aims to transform the treatment landscape for autoimmune diseases, moving beyond IgAN to other conditions driven by autoantibodies [40][41] - **Injection Site Reactions**: Approximately 24% of patients experienced injection site reactions, mostly mild, with no severe cases reported [90] Conclusion Vera Therapeutics is positioned strongly in the autoimmune disease treatment landscape, particularly with Atacucept for IgAN. The positive trial results, robust safety profile, and strategic commercial plans indicate significant potential for market capture and patient impact in the coming years.

Core Insights - Vera Therapeutics announced that the ORIGIN Phase 3 trial of atacicept for immunoglobulin A nephropathy (IgAN) met its primary endpoint, demonstrating significant efficacy in reducing proteinuria [1][7]. Efficacy Results - Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, measured by the 24-hour urine protein-to-creatinine ratio (UPCR), and a 42% reduction compared to placebo at week 36 (p<0.0001) [2][7]. - Other prespecified endpoints showed results consistent with or better than those observed in the ORIGIN Phase 2b trial [2][7]. Safety Profile - The safety profile of atacicept was favorable and comparable to that of the placebo [2][7]. Regulatory Plans - Vera plans to share these results with the FDA and intends to submit a Biologics License Application (BLA) for atacicept in IgAN in the fourth quarter of 2025, potentially allowing for US approval and commercial launch in 2026 [4][7]. Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study involving 431 adults with IgAN, with participants receiving either atacicept 150 mg or placebo [5][7]. - The trial continues to evaluate changes in kidney function over two years, with completion expected in 2027 [5][7]. Company Vision - Vera Therapeutics aims to advance the standard of care in IgAN and other autoimmune kidney diseases, aspiring to evolve kidney medicine practices [4][12].

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(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q Commission File Number: 001-40407 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporat ...

Financial Performance - Vera Therapeutics reported a net loss of $51.7 million for Q1 2025, compared to a net loss of $28.4 million in Q1 2024, representing an increase of 82% year-over-year[9]. - Operating expenses for Q1 2025 totaled $57.2 million, up from $31.1 million in Q1 2024, indicating an increase of 83% year-over-year[19]. - The weighted-average shares used in computing net loss per share increased to approximately 63.7 million in Q1 2025 from 51.0 million in Q1 2024[19]. - Vera's accumulated deficit reached $512.9 million as of March 31, 2025, compared to $461.3 million at the end of 2024[21]. Cash Position - The company had $589.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which is expected to fund operations through the potential approval and U.S. commercial launch of atacicept[10]. Clinical Development - Vera is on track to announce primary endpoint results from the pivotal ORIGIN 3 trial in Q2 2025, with plans for a Biologics License Application (BLA) submission for atacicept in Q4 2025[5][6]. - The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, showing statistically significant proteinuria reductions[12]. - Vera has expanded the atacicept development program to include additional autoimmune kidney diseases such as primary membranous nephropathy (PMN) and focal segmental glomerulosclerosis (FSGS)[7]. - The company completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in IgAN[7]. Product Development - Vera acquired exclusive development and commercialization rights to VT-109, a novel fusion protein targeting BAFF and APRIL, with potential applications across B cell mediated diseases[7].

Core Insights - Vera Therapeutics is approaching a significant milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, which may lead to a Biologics License Application (BLA) submission to the FDA in the second half of 2025, potentially allowing for approval and commercial launch in 2026 [2][4][8] - The company reported a net loss of $51.7 million for Q1 2025, an increase from a net loss of $28.4 million in Q1 2024, with net cash used in operating activities rising to $54.4 million from $33.8 million year-over-year [4][5][15] - As of March 31, 2025, Vera had $589.8 million in cash, cash equivalents, and marketable securities, which is deemed sufficient to fund operations through the potential approval and U.S. commercial launch of atacicept [5][17] Business Highlights - The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of eGFR compared to placebo [7] - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating its potential to significantly improve treatment outcomes compared to existing therapies [10] - Vera is expanding the atacicept development program to include additional autoimmune kidney diseases such as primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) [8][11] Financial Results - For Q1 2025, total operating expenses were $57.2 million, up from $31.1 million in Q1 2024, with research and development expenses increasing to $41.3 million from $23.2 million [15] - The net loss per share for Q1 2025 was $0.81, compared to $0.56 for the same period in 2024 [15] - The company’s total assets as of March 31, 2025, were $610.2 million, down from $655.7 million at the end of 2024, with total liabilities at $75.2 million [17][18]