HilleVax(HLVX) - 2025 Q1 - Quarterly Report

PART I FINANCIAL INFORMATION Financial Statements (Unaudited) The company reported a net loss of $6.1 million for Q1 2025, a significant reduction from $46.8 million in Q1 2024, driven by lower operating expenses after program discontinuation Condensed Consolidated Balance Sheets Total assets decreased to $178.8 million as of March 31, 2025, from $192.7 million, primarily due to reduced cash and cash equivalents, while liabilities also decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $47,485 | $154,467 | | Marketable securities | $112,054 | $16,965 | | Total current assets | $165,709 | $178,347 | | Total assets | $178,821 | $192,690 | | Liabilities & Equity | | | | Total current liabilities | $6,545 | $16,455 | | Total liabilities | $27,908 | $38,204 | | Total stockholders' equity | $150,913 | $154,486 | Condensed Consolidated Statements of Operations and Comprehensive Loss Net loss significantly improved to $6.1 million in Q1 2025 from $46.8 million in Q1 2024, primarily due to reduced R&D expenses and no in-process R&D costs Statement of Operations Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $1,983 | $25,978 | | In-process research and development | $0 | $15,325 | | General and administrative | $5,621 | $8,494 | | Total operating expenses | $7,604 | $49,797 | | Loss from operations | ($7,604) | ($49,797) | | Net loss | ($6,061) | ($46,829) | | Net loss per share, basic and diluted | ($0.12) | ($0.97) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $12.7 million in Q1 2025, with $94.3 million used in investing activities, leading to a $107.0 million net decrease in cash Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,718) | ($33,002) | | Net cash used in investing activities | ($94,264) | ($57,662) | | Net cash provided by financing activities | $0 | $15,062 | | Net decrease in cash, cash equivalents and restricted cash | ($106,982) | ($75,602) | | Cash, cash equivalents and restricted cash—end of period | $49,116 | $142,707 | Notes to Condensed Consolidated Financial Statements Notes detail accounting policies, the discontinuation of the HIL-214 program, the $15.0 million Kangh license agreement, debt repayment, and management's liquidity assessment - The company is a biopharmaceutical firm focused on vaccines, exploring strategic alternatives after discontinuing its HIL-214 infant program[19][108] - Management believes current working capital is sufficient to fund operations for at least the next twelve months from the financial statement issuance date[21] - In January 2024, the company entered an exclusive license agreement with Kangh for HIL-216, making an upfront payment of $15.0 million expensed as in-process R&D[81][82][83] - On July 19, 2024, the company fully repaid its $26.2 million outstanding loan with Hercules Capital, terminating the agreement[92] - Following HIL-214 infant development discontinuation, the company implemented a workforce reduction completed in January 2025 and terminated related vendor contracts[108][109][113] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the discontinuation of HIL-214 development due to trial results, significant reduction in Q1 2025 operating expenses, and a strong liquidity position of $159.5 million - The Phase 2b NEST-IN1 trial for HIL-214 in infants did not meet its primary efficacy endpoint, leading to discontinuation of development and exploration of strategic alternatives[116] - As of March 31, 2025, the company held $159.5 million in cash, cash equivalents, and marketable securities, deemed sufficient for at least the next 12 months[118][139][149] - In July 2024, the company fully repaid its term loan facility with Hercules, terminating the agreement[146] Results of Operations Total operating expenses drastically decreased to $7.6 million in Q1 2025 from $49.8 million in Q1 2024, driven by reduced R&D and general and administrative costs Comparison of Operations (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $1,983 | $25,978 | $(23,995) | | In-process research and development | $0 | $15,325 | $(15,325) | | General and administrative | $5,621 | $8,494 | $(2,873) | | Total operating expenses | $7,604 | $49,797 | $(42,193) | | Net loss | $(6,061) | $(46,829) | $40,768 | - The $24.0 million decrease in R&D expenses was primarily due to a $12.9 million reduction from HIL-214 discontinuation and $8.0 million in lower personnel costs[135] Liquidity and Capital Resources The company's capital sources include equity and debt, with $159.5 million in cash and equivalents as of March 31, 2025, deemed sufficient for the next 12 months Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,718) | $(33,002) | | Net cash used in investing activities | $(94,264) | $(57,662) | | Net cash provided by financing activities | $0 | $15,062 | - Net cash used in operating activities decreased to $12.7 million in Q1 2025 from $33.0 million in Q1 2024, primarily due to a smaller net loss[153][154] - Net cash used in investing activities increased to $94.3 million in Q1 2025, driven by $111.3 million in purchases of marketable securities[155] Quantitative and Qualitative Disclosures About Market Risk This section is omitted as the company qualifies as a smaller reporting company - The company has omitted this section as it is not applicable to a smaller reporting company[166] Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the reporting period end[167] - No material changes occurred in internal control over financial reporting during the quarter[168] PART II OTHER INFORMATION Legal Proceedings The company is not currently subject to any material legal proceedings - As of the filing date, the company is not a party to any material legal proceedings[170] Risk Factors No material changes have occurred to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes have occurred to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[171] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or issuer repurchases during the period - There were no unregistered sales of equity securities or issuer repurchases of equity securities[174][175] Other Information No officers or directors adopted or terminated Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements during Q1 2025 - No officers or directors adopted or terminated any Rule 10b5-1 trading plans during the three months ended March 31, 2025[178] Exhibits The report includes various exhibits, such as the Non-Employee Director Compensation Program, CEO and CFO certifications, and Inline XBRL documents - Filed exhibits include the Non-Employee Director Compensation Program (10.1), CEO and CFO certifications (31.1, 31.2, 32.1, 32.2), and XBRL data files[179]