AlloVir(ALVR) - 2023 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (unaudited) This section presents the unaudited condensed consolidated financial statements for Q1 2023, detailing a net loss of $41.2 million and total assets of $244.0 million Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Items | March 31, 2023 (in thousands USD) | December 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $115,698 | $106,092 | | Short-term investments | $86,872 | $127,703 | | Total current assets | $212,275 | $243,052 | | Total assets | $244,044 | $277,079 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $24,959 | $24,338 | | Total liabilities | $50,512 | $52,560 | | Total stockholders' equity | $193,532 | $224,519 | | Total liabilities and stockholders' equity | $244,044 | $277,079 | Condensed Consolidated Statements of Operations and Comprehensive Loss Statement of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | Research and development | $30,718 | $29,067 | | General and administrative | $12,513 | $14,126 | | Loss from operations | $(43,231) | $(43,193) | | Interest income | $1,325 | $148 | | Net loss | $(41,183) | $(43,863) | | Net loss per share — basic and diluted | $(0.44) | $(0.69) | Condensed Consolidated Statements of Changes in Stockholders' Equity - Total stockholders' equity decreased from $224.5 million at December 31, 2022, to $193.5 million at March 31, 2023, primarily driven by the net loss of $41.2 million, partially offset by $10.0 million in stock-based compensation[33] Condensed Consolidated Statements of Cash Flows Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(32,118) | $(46,476) | | Net cash provided by (used in) investing activities | $41,724 | $(54,979) | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $9,606 | $(101,455) | | Cash, cash equivalents, and restricted cash at end of period | $116,550 | $101,058 | Notes to Condensed Consolidated Financial Statements - AlloVir is a late clinical-stage cell therapy company, with its lead product, posoleucel, in three ongoing Phase 3 trials expected to report data in 2024, following positive Phase 2 results in February 2023[38] - The company believes its $202.6 million in cash, cash equivalents, and short-term investments as of March 31, 2023, are sufficient to fund planned operations for at least twelve months, addressing going concern considerations[40][44] - The adoption of ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326), on January 1, 2023, did not materially impact the condensed consolidated financial statements[52] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition and operational results, reporting a net loss of $41.2 million for Q1 2023, with $202.6 million in cash sufficient for twelve months of operations - The company's lead product, posoleucel, is in three ongoing Phase 3 registrational trials with data readouts expected in 2024, following positive Phase 2 results for BK viremia in kidney transplant patients in February 2023[89] Comparison of Operating Expenses (in thousands USD) | Expense Category | Three Months Ended March 31, 2023 (in thousands USD) | Three Months Ended March 31, 2022 (in thousands USD) | Change (in thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | $30,718 | $29,067 | $1,651 | | General and administrative | $12,513 | $14,126 | $(1,613) | | Total operating expenses | $43,231 | $43,193 | $38 | - As of March 31, 2023, the company held $202.6 million in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations and capital expenditures for at least the next twelve months[94][115] - Net cash used in operating activities decreased to $32.1 million in Q1 2023 from $46.5 million in Q1 2022, primarily due to the timing of changes in net operating assets and liabilities[123][124] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the company is not required to provide disclosures for this item - As a smaller reporting company, AlloVir is not required to disclose quantitative and qualitative information about market risk[134] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - The company's management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2023[136] - No material changes in the company's internal control over financial reporting occurred during the quarter[137] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings - As of the reporting date, the company is not a party to any material arbitration or legal proceedings[141] Item 1A. Risk Factors This section outlines key risks, including dependence on posoleucel's success, high development costs, need for additional funding, and intense competition - The company's business is highly dependent on its lead product candidate, posoleucel, and its ability to complete clinical testing and obtain regulatory approval[7][179] - As a late clinical-stage entity, the company has incurred net losses since inception, with an accumulated deficit of $507.0 million as of March 31, 2023, and anticipates significant future losses[7][216] - Substantial additional funding is required, and an inability to raise capital could force delays, reductions, or elimination of development programs or commercialization efforts[8][220] - The company faces substantial competition from other pharmaceutical and biotechnology companies, which could significantly impact its commercial opportunities if competitors develop more successful products[10][163] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities during the quarter[280] Item 3. Defaults Upon Senior Securities The company reports no defaults upon senior securities - There were no defaults upon senior securities[280] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable[280] Item 5. Other Information The company reports no other information for this period - There is no other information to report[280] Item 6. Exhibits This section lists exhibits filed with Form 10-Q, including Sarbanes-Oxley certifications and Inline XBRL data files - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[285] - The report incorporates various Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation) for financial data tagging[281][282][283]