Vera Therapeutics(VERA)

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Vera Therapeutics Presents 72-week eGFR Stabilization and Rapid Hematuria Improvement in Phase 2b ORIGIN Study of Atacicept in IgAN at the 61st European Renal Association Congress
globenewswire.com· 2024-05-25 13:40
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]
Vera Therapeutics(VERA) - 2024 Q1 - Quarterly Report
2024-05-09 21:40
[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)
Vera Therapeutics(VERA) - 2024 Q1 - Quarterly Results
2024-05-09 11:30
Exhibit 99.1 Vera Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results BRISBANE, Calif., May 9, 2024 – 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 reported its business highlights and financial results for the first quarter ended March 31, 2024. "This quarter, we shared results from our Phase 2b clinical trial th ...
Vera Therapeutics(VERA) - 2023 Q4 - Annual Report
2024-03-27 00:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 jurisdiction ...
Vera Therapeutics(VERA) - 2023 Q4 - Annual Results
2024-03-20 11:30
Clinical Trial Progress - Presented positive 72-week data from the Phase 2b ORIGIN clinical trial, showing no loss of kidney function over the duration of treatment[3] - Phase 3 ORIGIN 3 clinical trial of atacicept for IgAN is on track, with topline data expected in the first half of 2025[3][12] - The Phase 2b ORIGIN trial of atacicept in IgAN showed statistically significant reductions in proteinuria and stabilized eGFR at weeks 24, 36, and 72[14] Financial Performance - Reported a net loss of $96.0 million for the year ended December 31, 2023, compared to a net loss of $89.1 million in the previous year[10] - Net cash used in operating activities was $92.2 million for the year ended December 31, 2023, compared to $67.6 million in the previous year[10] - Research and development expenses increased to $78.2 million in 2023 from $69.0 million in 2022[6] Financing and Cash Position - Completed $287.5 million financing, extending the company's cash runway through potential approval and commercial launch[3] - Reported $160.7 million in cash, cash equivalents, and marketable securities as of December 31, 2023[11] - Completed an upsized public offering of Class A common stock with gross proceeds of approximately $287.5 million in February 2024[12] Product Pipeline - MAU868, a potential first-in-class monoclonal antibody, has the potential to neutralize BK virus infection, with no approved treatments currently available[15]
Vera Therapeutics(VERA) - 2023 Q3 - Quarterly Report
2023-11-09 21:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number: 001-40407 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) 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, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Delaware 81-2744449 (State or other ju ...
Vera Therapeutics(VERA) - 2023 Q2 - Quarterly Report
2023-08-10 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 jurisdiction of incorporation or organization) 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 June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) ...
Vera Therapeutics (VERA) Investor Presentation - Slideshow
2023-05-16 14:53
1. One patient with COVID-19 was hospitalized and recovered. 28 © 2023 VERA THERAPEUTICS, INC. Ability to leverage ORIGIN worldwide sites ORIGIN Subgroup Analyses Inform Phase 3 Design to Maximize Competitive Positioning 2020 2023 2024 2025 Phase 2b Trial Ongoing Results Corporate Presentation © 2023 VERA THERAPEUTICS, INC. This material has been made available to you with the consent of Vera Therapeutics, Inc. ("we", "us", "our", or the "Company"). Statements in this presentation that are not statements of ...
Vera Therapeutics(VERA) - 2023 Q1 - Quarterly Report
2023-05-11 20:40
Summary of Risks Associated with Our Business [Summary of Risks Associated with Our Business](index=2&type=section&id=SUMMARY%20OF%20RISKS%20ASSOCIATED%20WITH%20OUR%20BUSINESS) The company identifies material risks centered on its clinical-stage nature, including no approved products, dependence on two candidates, and the need for substantial capital - The company has **not completed any clinical trials** for its lead product candidate, atacicept, and has no products approved for commercial sale[8](index=8&type=chunk) - Vera will require **substantial additional capital** for its operations, and failure to raise capital may force the company to delay, reduce, or eliminate its programs[8](index=8&type=chunk) - The business is **substantially dependent on the success** of its clinical-stage product candidates, atacicept and MAU868[9](index=9&type=chunk) - The company has incurred **net losses since inception** and expects this trend to continue for the foreseeable future[9](index=9&type=chunk) - Losing development rights to atacicept or MAU868 by **breaching license agreements** with Ares Trading S.A. or Novartis is a key risk[9](index=9&type=chunk) PART I. FINANCIAL INFORMATION [Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) The company's financial statements show increased cash from a public offering, rising R&D costs, and continued net losses [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Total assets and stockholders' equity grew significantly due to a follow-on offering, while total liabilities decreased slightly Condensed Balance Sheet Highlights (in thousands) | | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $137,385 | $43,459 | | Total current assets | $204,449 | $125,698 | | Total assets | $209,604 | $131,435 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $23,529 | $25,600 | | Total liabilities | $51,895 | $54,527 | | Total stockholders' equity | $157,709 | $76,908 | | Total liabilities and stockholders' equity | $209,604 | $131,435 | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net loss widened in Q1 2023 compared to Q1 2022, driven by a significant increase in operating expenses Condensed Statement of Operations (in thousands) | | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Research and development | $25,108 | $12,549 | | General and administrative | $6,150 | $4,472 | | **Total operating expenses** | **$31,258** | **$17,021** | | Loss from operations | $(31,258) | $(17,021) | | **Net loss** | **$(30,069)** | **$(17,085)** | | Net loss per share, basic and diluted | $(0.80) | $(0.71) | [Condensed Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased substantially, primarily due to net proceeds from a follow-on common stock offering - The company raised approximately **$107.7 million in net proceeds** from an underwritten follow-on offering during the three months ended March 31, 2023[17](index=17&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash flows show significant cash provided by financing activities from a stock offering, offsetting cash used in operations Condensed Statement of Cash Flows (in thousands) | | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(26,292) | $(8,981) | | Net cash provided by (used in) investing activities | $12,234 | $(39,455) | | Net cash provided by financing activities | $107,984 | $80,268 | | **Net increase in cash, cash equivalents and restricted cash** | **$93,926** | **$31,832** | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's liquidity, confirming sufficient cash for the next 12 months, and significant future milestone obligations - In February 2023, the company completed a follow-on public offering, receiving **net proceeds of approximately $107.7 million**[24](index=24&type=chunk) - As of March 31, 2023, the company had an **accumulated deficit of $243.2 million** but believes its cash is sufficient to fund operations for at least the next 12 months[25](index=25&type=chunk)[26](index=26&type=chunk) - As of March 31, 2023, the company had **$25.0 million in outstanding borrowings** under its Loan Facility with Oxford[89](index=89&type=chunk)[90](index=90&type=chunk) - Under the Ares Agreement for atacicept, the company is obligated to pay up to **$176.5 million in regulatory milestones** and up to **$515.0 million in commercial milestones**[114](index=114&type=chunk) - For MAU868, the company is obligated to make future milestone payments of up to **$7.0 million to Amplyx** and **$62.0 million to Novartis**[122](index=122&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategic focus on the atacicept IgAN trial, rising operating expenses, and sufficient liquidity until early 2026 - The company is prioritizing the advancement of atacicept in IgAN into a pivotal Phase 3 trial while delaying enrollment and resource commitment to other programs[132](index=132&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2023 | Q1 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $25,108 | $12,549 | $12,559 | 100% | | General and administrative | $6,150 | $4,472 | $1,678 | 38% | - The increase in R&D expenses was primarily due to **contract drug manufacturing for atacicept** and higher compensation costs from increased headcount[152](index=152&type=chunk) - The company believes its **$197.2 million in cash**, equivalents, and marketable securities will be sufficient to fund operations **until early 2026**[168](index=168&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its short-term investments, which is not considered material - The company's primary market risk is **interest rate sensitivity** on its cash, cash equivalents, and short-term marketable securities, which is not expected to have a material impact[189](index=189&type=chunk) - Inflation is acknowledged as a factor that increases costs but is not believed to have had a significant impact on the results for the periods presented[190](index=190&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of the end of the quarter - The CEO and CFO concluded that as of March 31, 2023, the company's **disclosure controls and procedures were effective**[192](index=192&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, these controls[193](index=193&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company reports it is not currently a party to any material legal proceedings - As of the report date, the company is **not a party to any material legal proceedings**[195](index=195&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company details significant risks related to its finances, clinical development, regulation, intellectual property, and third-party reliance - The company has **no products approved for sale**, has incurred net losses since inception, and will require substantial additional capital to finance operations[197](index=197&type=chunk)[199](index=199&type=chunk)[204](index=204&type=chunk) - The business is **heavily dependent on the success** of its two clinical-stage product candidates, atacicept and MAU868[212](index=212&type=chunk) - The company faces **significant competition** from multinational pharmaceutical companies and specialized biotech firms with greater resources[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk) - The company's success depends on protecting its intellectual property and **not breaching its license agreements** with Ares or Novartis[338](index=338&type=chunk)[347](index=347&type=chunk) - The company **relies on third parties for manufacturing and to conduct clinical trials**, increasing risks related to supply, cost, and compliance[414](index=414&type=chunk)[421](index=421&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company's loan agreement with Oxford restricts its ability to declare and pay dividends without prior written consent - The company's Loan Agreement with Oxford **restricts its ability to pay dividends** without prior written consent[489](index=489&type=chunk) [Defaults Upon Senior Securities](index=83&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - Not applicable[490](index=490&type=chunk) [Mine Safety Disclosures](index=83&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - Not applicable[491](index=491&type=chunk) [Other Information](index=83&type=section&id=Item%205.%20Other%20Information) The company reports that there is no other information to disclose for this item - None[492](index=492&type=chunk) [Exhibits](index=84&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents and required officer certifications - Lists exhibits filed with the report, including corporate governance documents and officer certifications (302 and 906)[494](index=494&type=chunk)
Vera Therapeutics(VERA) - 2022 Q4 - Annual Report
2023-03-28 20:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 ...