Vera Therapeutics(VERA)
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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 ...
Vera Therapeutics (VERA) Investor Presentation - Slideshow
2023-03-10 12:30
Sean Grant, MBA Chief Financial Officer | --- | --- | --- | --- | --- | |-------|----------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------|-------------------------------------------------| | | Joanne Curley, PhD Chief Development Officer | Lauren Frenz, MBA Chief Business Officer | | Joe Young, CPA, MBA Chief Accounting Officer | | | • >20 years drug dev, former VP project | • 15 years industry expe ...
Vera Therapeutics (VERA) Investor Presentation - Slideshow
2023-01-11 18:46
Forward Looking Statements This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. | --- | --- | |------------------------|--------------------------------| | | | | | | | Corporate Presentation | | | | | | C | | | January 2023 | | | | | | | | | ...
Vera Therapeutics (VERA) Investor Presentation - Slideshow
2022-09-16 22:08
therapeutics | --- | --- | --- | --- | --- | |------------------------|--------------------------------|-------|-------|-------| | | | | | | | Corporate Presentation | | | | | | September 2022 | C | | | | | | | | | | | | | | | | | | | | | | | | C | | | | | | © 2022 VERA THERAPEUTICS, INC. | | | | Forward Looking Statements Disclaimer 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 sta ...
Vera Therapeutics (VERA) Investor Presentation - Slideshow
2022-08-11 17:54
therapeutics | --- | --- | --- | --- | --- | |------------------------|--------------------------------|-------|-------|-------| | | | | | | | Corporate Presentation | | | | | | | C | | | | | August 2022 | | | | | | | | | | | | | | | | | | | C | | | | | | © 2022 VERA THERAPEUTICS, INC. | | | | Forward Looking Statements Disclaimer 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 statem ...
Vera Therapeutics(VERA) - 2022 Q2 - Quarterly Report
2022-08-10 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 June 30, 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 or other jurisdi ...