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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]

Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Enrollment and Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - Participants are randomized to receive either atacicept 150 mg or placebo via self-administered weekly subcutaneous injections for a 104-week double-blind period, followed by a 52-week open-label extension [2] Efficacy and Safety Data - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, with a key secondary endpoint assessing kidney function via estimated glomerular filtration rate (eGFR) over 104 weeks [3] - The Phase 2b ORIGIN trial demonstrated significant reductions in proteinuria and stabilization of eGFR, supporting the efficacy of atacicept [6] Future Plans and Market Position - The company plans to submit a BLA for atacicept in the second half of 2025, with a potential commercial launch in 2026 [2][8] - Vera Therapeutics retains all global developmental and commercial rights to atacicept and is also developing MAU868, a monoclonal antibody targeting BK virus [9]

Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [9] - Atacicept is a recombinant fusion protein that targets B-cell activating factors, aiming to reduce autoantibody production associated with autoimmune diseases like IgAN and lupus nephritis [5][9] - The company is also developing MAU868, a monoclonal antibody for BK virus infections, and holds an exclusive license for a next-generation fusion protein targeting BAFF and APRIL [9] Clinical Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, while the key secondary endpoint assesses kidney function via estimated glomerular filtration rate (eGFR) through 104 weeks [3] - The ORIGIN Phase 2b trial previously demonstrated significant reductions in proteinuria and stabilization of kidney function, reinforcing the potential of atacicept as a best-in-class therapy for IgAN [6]

Financial Position - As of December 31, 2024, the company had $640.9 million in cash, cash equivalents, and marketable securities, expected to fund operations for at least the next 12 months[270]. - The company incurred net losses of $152.1 million and $96.0 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $461.3 million as of December 31, 2024[273]. - The company will require substantial additional capital to finance ongoing operations and may need to seek funding through various means, which could dilute stockholders[272]. - The company has federal and state net operating loss (NOL) carryforwards of $175.4 million and $37.5 million, respectively, which will begin expiring in 2032 and 2036 if not utilized[410]. - The company has $165.2 million of federal NOL carryforwards that do not expire, providing some tax relief potential[410]. - The company expects to incur significant additional losses for the foreseeable future, indicating a lack of profitability[410]. Research and Development - The company plans to continue research and development of atacicept, MAU868, and VT-109, which are in clinical and pre-clinical stages, requiring significant capital investment[281]. - The company has completed a limited number of clinical trials for its lead product candidate, atacicept, and has no products approved for commercial sale[267]. - The company’s future success is heavily dependent on timely completion of clinical trials and obtaining regulatory approvals for its product candidates[282]. - The company is seeking orphan drug designation for atacicept for the treatment of IgAN, which is defined as a patient population of fewer than 200,000 in the United States[336]. - The company received orphan medicinal product designation for atacicept in the EU in October 2024, which provides a 10-year period of market exclusivity for the approved therapeutic indication[338]. - MAU868 has received Fast Track designation from the FDA for the prevention of BK viremia in renal transplant and hematopoietic stem cell transplant, but this may not expedite the development or approval process[340]. - The company may seek accelerated approval for atacicept based on positive Phase 3 trial results, which could allow for a faster path to commercialization[342]. Regulatory and Compliance Risks - The company faces challenges in obtaining regulatory approval, as the approval process is lengthy and unpredictable, potentially harming its business and financial condition[318]. - Regulatory authorities may require additional trials or studies based on varying interpretations of clinical data, potentially delaying or preventing product approvals[291]. - The company is subject to potential penalties and sanctions if it fails to comply with regulatory requirements, which could inhibit its ability to commercialize products and generate revenue[333]. - The FDA's policies may change, which could limit or delay regulatory approvals for the company's product candidates[334]. - The company may face significant post-marketing regulatory requirements and ongoing oversight if any product candidate receives approval, which could include burdensome studies and compliance measures[332]. - The company is exploring the use of accelerated approval pathways, but failure to obtain such approval could extend the time to commercialization and increase development costs[343]. Market and Competitive Landscape - The biotechnology industry is highly competitive, with significant players including multinational pharmaceutical companies and specialized biotechnology firms, which may hinder the company's ability to develop and commercialize its products effectively[312]. - The commercial viability of product candidates could be significantly reduced if competitors bring products to market before the company[297]. - Competitors may obtain regulatory approval more rapidly and have established distribution channels, which could limit the company's market position[314]. - The company intends to seek marketing approval for atacicept, MAU868, and VT-109 in the U.S., EU, and other jurisdictions, but will be subject to varying pricing regulations and reimbursement practices[349]. - Coverage and adequate reimbursement from third-party payors are essential for the commercialization of product candidates, and insufficient reimbursement could hinder market success[350]. - The U.S. healthcare industry is increasingly focused on cost containment, which may lead to limited coverage and reimbursement for new products[352]. Clinical Trial Challenges - Clinical trial failures may arise from various factors, including trial design flaws and patient enrollment criteria, potentially harming the company's business and financial condition[285]. - Delays in clinical trials are common and can result from regulatory disagreements, protocol changes, and participant enrollment issues, which may increase costs and jeopardize product sales[292]. - The company may face challenges in enrolling sufficient participants for clinical trials due to competition and difficulties in identifying patients, which could lead to significant delays[298]. - The company has ongoing clinical trials for its product candidates, including atacicept, MAU868, and VT-109, but adverse events or side effects could significantly impact trial success and market acceptance[324]. - The company may face difficulties in recruiting participants for clinical trials if significant adverse events are observed, which could lead to trial suspension[327]. Intellectual Property Risks - The company’s ability to protect its intellectual property is crucial for its commercial success, with potential risks of patent invalidation or infringement[415]. - The company’s patent applications may not result in patents being issued, and existing patents may be challenged or invalidated, impacting its competitive advantage[434]. - The company faces significant risks related to intellectual property rights, which may not adequately protect its competitive advantage[441]. - The competitive landscape for acquiring third-party intellectual property rights is challenging, with established companies having advantages[453]. - Unfavorable outcomes in patent litigation could lead to significant liability and loss of patent protection, affecting market competitiveness[455]. Operational and Management Challenges - The company has never commercialized a product candidate before and currently lacks the necessary expertise, personnel, and resources for successful commercialization[402]. - Attracting and retaining skilled personnel is critical, with significant competition in the biotechnology field impacting the company's ability to execute its business plan[396]. - The company may face challenges in managing growth and responsibilities associated with being a public company[405]. - The company relies on independent organizations and consultants for key services, raising concerns about the availability and quality of these services[406]. - The company must establish sales and marketing capabilities or partner with third parties to successfully commercialize its product candidates[400]. Legal and Regulatory Compliance - Non-compliance with healthcare laws and regulations may expose the company to significant penalties, including civil, criminal, and administrative penalties, and reputational harm[373]. - The company is subject to evolving U.S. and foreign laws regarding data privacy, with potential for significant adverse business consequences if compliance is not maintained[378]. - Numerous U.S. states have enacted comprehensive privacy laws, increasing compliance costs and potential liabilities for the company[379]. - The company must comply with stringent data privacy laws, which could lead to regulatory investigations and significant fines if not adhered to[374]. - Changes in regulations could require additional clinical trials, manufacturing method changes, or product recalls, impacting commercial value[365].

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]