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 ...

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 ...

"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 ...

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 ...

Core Insights - Vera Therapeutics announced positive results from its Phase 2b ORIGIN trial of atacicept for immunoglobulin A nephropathy (IgAN), demonstrating stabilized kidney function and rapid improvements in hematuria over 72 weeks [1][2][4] 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 [19] Clinical Trial Results - The Phase 2b ORIGIN trial showed that participants receiving atacicept for 72 weeks had stable estimated glomerular filtration rate (eGFR) and significant reductions in Gd-IgA1, hematuria, and urine protein to creatinine ratio (UPCR) [2][12] - Atacicept treatment resulted in hematuria resolution in 80% of participants compared to 5% in the placebo group, with significant improvements observed as early as 4 weeks after treatment initiation [4][12] - The trial met its primary and key secondary endpoints, indicating statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR compared to placebo [12] Upcoming Milestones - The company plans to present full 96-week data from the Phase 2b ORIGIN trial in the fourth quarter of 2024 and expects to complete enrollment for the pivotal Phase 3 ORIGIN 3 trial by the third quarter of 2024 [14][20] Safety Profile - The cumulative safety profile of atacicept was comparable to the randomized period, with a retention rate of 91% through 72 weeks, supporting its potential for long-term disease modification in IgAN [2][12] Disease Background - IgAN, also known as Berger's disease, is a serious autoimmune disease of the kidney that can lead to end-stage kidney disease in up to 50% of patients, highlighting the high unmet medical need for effective treatments [17]

[Summary of Risks Associated with Our Business](index=2&type=section&id=SUMMARY%20OF%20RISKS%20ASSOCIATED%20WITH%20OUR%20BUSINESS) The company faces material risks due to its clinical-stage status, lack of approved products, and history of net losses - The company identifies several material risks associated with its business, highlighting its clinical-stage nature with no approved products and a history of net losses[9](index=9&type=chunk) - Key operational and strategic risks include: - Substantial dependence on the clinical success and regulatory approval of its lead product candidates, atacicept and MAU868[9](index=9&type=chunk) - The need for substantial additional capital to finance operations, without which development programs may be delayed or eliminated[9](index=9&type=chunk) - Reliance on third parties for clinical trials and manufacturing, where failure to perform could significantly harm the business[10](index=10&type=chunk) - Dependence on license agreements with Ares and Novartis; a breach could lead to the loss of rights to develop atacicept or MAU868[10](index=10&type=chunk) - Significant competition from other companies that may discover, develop, or commercialize products more successfully[9](index=9&type=chunk) [PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20%28Unaudited%29) Unaudited Q1 2024 condensed financial statements show increased cash and marketable securities from a public offering, with continued net losses from R&D activities [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, total assets significantly increased to **$419.4 million** from **$175.5 million** at year-end 2023, driven by an equity offering, with stockholders' equity growing to **$353.5 million** Condensed Balance Sheet Highlights (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $69,105 | $45,681 | | Marketable securities | $334,559 | $115,035 | | Total assets | $419,356 | $175,546 | | **Liabilities & Equity** | | | | Total liabilities | $65,814 | $73,861 | | Total stockholders' equity | $353,542 | $101,685 | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2024, the company reported a net loss of **$28.4 million**, a slight improvement from the **$30.1 million** net loss in the same period of 2023, primarily due to higher interest income offsetting a small decrease in total operating expenses, with net loss per share improving to **$0.56** from **$0.80** year-over-year Statement of Operations Summary (in thousands, except per share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $23,200 | $25,108 | | General and administrative | $7,912 | $6,150 | | **Loss from operations** | **($31,112)** | **($31,258)** | | Interest income | $4,186 | $1,623 | | Interest expense | ($1,906) | ($874) | | **Net loss** | **($28,383)** | **($30,069)** | | Net loss per share | ($0.56) | ($0.80) | [Condensed Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased substantially from **$101.7 million** at December 31, 2023, to **$353.5 million** at March 31, 2024, primarily driven by **$269.6 million** in net proceeds from a follow-on offering - A follow-on offering in Q1 2024 resulted in the issuance of 9,274,194 shares of common stock, generating net proceeds of **$269.6 million** ($269,592 thousand)[18](index=18&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For Q1 2024, net cash used in operating activities was **$33.8 million**, investing activities used **$219.3 million**, and financing activities provided **$276.5 million**, primarily from a stock offering, resulting in a net increase in cash and cash equivalents of **$23.4 million** Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($33,830) | ($26,292) | | Net cash (used in) provided by investing activities | ($219,286) | $12,234 | | Net cash provided by financing activities | $276,540 | $107,984 | - The company received **$287.5 million** in gross proceeds from its follow-on offering in Q1 2024, which after offering costs of **$17.9 million**, provided significant financing[21](index=21&type=chunk) [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's financial position and accounting policies, including its liquidity status with **$403.7 million** in cash, a **$50 million** loan agreement, the February 2024 follow-on offering that raised approximately **$269.6 million** net, and significant future milestone payment obligations for atacicept and MAU868 - As of March 31, 2024, the company had cash, cash equivalents, and marketable securities of **$403.7 million**; management believes this is sufficient to fund operations for at least 12 months from the financial statement issuance date[25](index=25&type=chunk)[26](index=26&type=chunk) - In February 2024, the company completed a follow-on public offering, selling 9,274,194 shares of Class A common stock at **$31.00 per share**[60](index=60&type=chunk) - The company has an outstanding loan of **$50.0 million** under its agreement with Oxford Finance, with interest-only payments until December 2026 and maturity in December 2027[53](index=53&type=chunk)[54](index=54&type=chunk)[56](index=56&type=chunk) - The company is obligated to pay Ares up to **$176.5 million** in regulatory milestones and up to **$515.0 million** in commercial milestones for atacicept; for MAU868, it owes up to **$7.0 million** to Amplyx and **$62.0 million** to Novartis in future milestones[76](index=76&type=chunk)[83](index=83&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on advancing its lead product candidate, atacicept, for IgAN following positive Phase 2b results, noting a decrease in R&D expenses offset by increased clinical trial and personnel costs, and a significantly bolstered liquidity from a **$269.6 million** net proceed from a February 2024 follow-on offering [Overview](index=27&type=section&id=Overview_MD%26A) Vera Therapeutics, a late clinical-stage biotech company, focuses on developing treatments for serious immunological diseases, with its lead candidate, atacicept, in a pivotal Phase 3 trial for IgAN, while delaying other programs to prioritize this trial, and has incurred significant losses since inception - The company's lead product candidate, atacicept, is being evaluated in a pivotal Phase 3 clinical trial for IgAN, which was initiated in the second quarter of 2023[97](index=97&type=chunk) - To prioritize the IgAN program, the company delayed enrollment in the pivotal Phase 3 trial for lupus nephritis (LN) and commitment of resources to the MAU868 program in January 2023[97](index=97&type=chunk)[158](index=158&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations_MD%26A) For Q1 2024, R&D expenses decreased by **$1.9 million** (8%) to **$23.2 million** due to reduced contract drug manufacturing, offset by higher clinical trial and personnel costs, while general and administrative expenses increased by **$1.8 million** (29%) to **$7.9 million**, resulting in a net loss of **$28.4 million** Research and Development Expenses Breakdown (in thousands) | Expense Category | Q1 2024 | Q1 2023 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Contract drug manufacturing | $7,748 | $15,494 | ($7,746) | (50%) | | Clinical trial expenses | $6,780 | $4,736 | $2,044 | 43% | | Consulting and professional services | $2,195 | $642 | $1,553 | 242% | | Compensation and related benefits | $5,967 | $3,999 | $1,968 | 49% | | **Total R&D Expenses** | **$23,200** | **$25,108** | **($1,908)** | **(8%)** | - General and administrative expenses increased by **$1.8 million** (29%) in Q1 2024 compared to Q1 2023, primarily due to a **$1.2 million** increase in payroll and related expenses from increased headcount and a **$0.9 million** increase in professional services fees[118](index=118&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources_MD%26A) The company's liquidity was significantly strengthened in Q1 2024, with cash, cash equivalents, and marketable securities totaling **$403.7 million** as of March 31, 2024, primarily due to **$269.6 million** net proceeds from a February 2024 public offering, ensuring sufficient funds for at least the next 12 months, alongside a **$50.0 million** loan agreement - As of March 31, 2024, the company had **$403.7 million** in cash, cash equivalents and marketable securities[101](index=101&type=chunk)[124](index=124&type=chunk) - In February 2024, a follow-on public offering generated net proceeds of approximately **$269.6 million**[121](index=121&type=chunk) - The company has a loan agreement with Oxford Finance with an outstanding principal of **$50.0 million** as of March 31, 2024; the loan matures in December 2027, with interest-only payments required until December 2026[134](index=134&type=chunk)[135](index=135&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that this item is not required, indicating it is likely a smaller reporting company and/or emerging growth company exempt from this disclosure - Disclosure for this item is not required[146](index=146&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that as of March 31, 2024, the company's disclosure controls and procedures were effective[148](index=148&type=chunk) - No changes in internal control over financial reporting were identified during the quarter ended March 31, 2024, that have materially affected or are likely to materially affect internal controls[149](index=149&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[151](index=151&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company outlines extensive risks to its business, categorized into financial, clinical development, regulatory, commercial, intellectual property, and operational areas, including dependence on atacicept, need for funding, uncertain clinical trials, competition, reliance on third parties, and licensed IP - Financial Risks: The company requires substantial additional capital, has a history of net losses, and may be unable to achieve profitability; its loan agreement also places restrictions on its financial flexibility[155](index=155&type=chunk)[160](index=160&type=chunk)[166](index=166&type=chunk) - Clinical and Development Risks: The business is substantially dependent on the success of atacicept and MAU868; clinical development is a lengthy, expensive, and uncertain process, with risks of trial delays, enrollment difficulties, and unfavorable outcomes[169](index=169&type=chunk)[171](index=171&type=chunk)[179](index=179&type=chunk) - Intellectual Property Risks: The company's success depends on protecting its IP and its license agreements with Ares and Novartis; a breach could result in the loss of development rights for atacicept or MAU868[309](index=309&type=chunk)[318](index=318&type=chunk) - Third-Party Reliance Risks: The company relies on third-party CROs to conduct clinical trials and on third-party manufacturers for drug supply; failure by these parties to perform could delay or prevent development and commercialization[383](index=383&type=chunk)[390](index=390&type=chunk) - Regulatory and Commercialization Risks: The company faces a lengthy and unpredictable regulatory approval process, significant competition, and challenges in achieving market acceptance and favorable reimbursement for its products if approved[206](index=206&type=chunk)[199](index=199&type=chunk)[241](index=241&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=130&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section notes that the company's loan agreement with Oxford restricts its ability to declare and pay dividends without prior written consent - The terms of the Loan Agreement with Oxford restrict the company's ability to declare and pay dividends without prior consent[457](index=457&type=chunk) [Defaults Upon Senior Securities](index=130&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - Not applicable[458](index=458&type=chunk) [Mine Safety Disclosures](index=130&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - Not applicable[459](index=459&type=chunk) [Other Information](index=130&type=section&id=Item%205.%20Other%20Information) The company disclosed that its former Chief Medical Officer, Celia Lin, M.D., terminated her Rule 10b5-1 trading arrangement on January 19, 2024 Director and Officer Trading Arrangements | Name | Position | Action | Date | Plan Type | | :--- | :--- | :--- | :--- | :--- | | Celia Lin, M.D. | Chief Medical Officer (former) | Termination | Jan 19, 2024 | Rule 10b5-1 | [Exhibits](index=133&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including organizational documents, material contracts such as employment offer letters, and certifications by the CEO and CFO - Filed exhibits include offer letters for new executives Robert Brenner, M.D., and William Turner, and certifications required by the Sarbanes-Oxley Act[462](index=462&type=chunk)