Aura Biosciences(AURA) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section covers unaudited financial statements, management's discussion, market risk, and internal controls Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements for Aura Biosciences, Inc. for the quarterly period ended June 30, 2025, reflecting increased cash from financing and widening net losses Condensed Consolidated Balance Sheets The balance sheet as of June 30, 2025, shows total assets of $204.4 million, driven by a rise in cash to $107.4 million from a follow-on offering, with total liabilities slightly decreasing and stockholders' equity increasing Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $107,367 | $31,693 | | Total Assets | $204,397 | $182,503 | | Total Liabilities | $29,768 | $30,533 | | Total Stockholders' Equity | $174,629 | $151,970 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, the company reported a net loss of $27.0 million, primarily due to higher research and development expenses, with the six-month net loss widening to $54.5 million Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $22,882 | $16,879 | $46,225 | $33,932 | | General and administrative | $5,731 | $5,883 | $11,423 | $11,145 | | Total operating loss | $(28,613) | $(22,762) | $(57,648) | $(45,077) | | Net loss | $(27,019) | $(20,337) | $(54,502) | $(40,043) | | Net loss per share | $(0.47) | $(0.41) | $(1.01) | $(0.81) | Condensed Consolidated Statements of Stockholders' Equity Total stockholders' equity increased to $174.6 million by June 30, 2025, primarily driven by $46.5 million in net proceeds from a follow-on offering, partially offset by a $54.5 million net loss - The company completed a follow-on offering, issuing 11,735,565 shares of common stock and various warrants, resulting in net proceeds of approximately $69.9 million after costs[17][44] Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2025, net cash used in operating activities was $44.1 million, while investing activities provided $49.8 million and financing activities provided $70.0 million, leading to a net cash increase of $75.7 million Six-Month Cash Flow Summary (in thousands) | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(44,129) | $(40,580) | | Net cash provided by investing activities | $49,790 | $29,237 | | Net cash provided by financing activities | $70,025 | $336 | | Net increase (decrease) in cash | $75,686 | $(11,007) | Notes to Unaudited Condensed Consolidated Financial Statements The notes detail the company's focus on its lead candidate, bel-sar, its reliance on capital raises, the May 2025 follow-on offering, and management's assertion of sufficient funding for the next 12 months - Aura Biosciences is a clinical-stage biotechnology company focused on developing its lead candidate, bel-sar, a Virus-Like Drug Conjugate (VDC), for the treatment of solid tumors, with an initial focus on ocular and urologic oncology[23] - In May 2025, the company completed a follow-on offering, receiving approximately $69.9 million in net proceeds after deducting underwriting discounts and commissions[26][44] - The company expects its cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance of these financial statements[27] - As of June 30, 2025, there was $16.7 million of unrecognized compensation expense related to stock options and $19.5 million related to unvested restricted stock units, expected to be recognized over weighted-average periods of 2.89 and 3.07 years, respectively[57][58] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial performance and operational progress, highlighting increased R&D expenses for the bel-sar Phase 3 trial, a $54.5 million net loss, and $177.3 million in cash and marketable securities expected to fund operations into the first half of 2027 - The company's lead candidate, bel-sar, is in an ongoing global Phase 3 CoMpass trial for the first-line treatment of early choroidal melanoma, with enrollment potentially completing as early as the end of 2025[93] - Bel-sar is also being developed for other indications, including a Phase 2 trial for metastases to the choroid and a Phase 1b/2 trial for non-muscle invasive bladder cancer (NMIBC)[95][98] Comparison of Operating Results (Six Months Ended June 30, in thousands) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $46,225 | $33,932 | $12,293 | | General and administrative | $11,423 | $11,145 | $278 | | Total operating expenses | $57,648 | $45,077 | $12,571 | | Net loss | $(54,502) | $(40,043) | $(14,459) | - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of $177.3 million, which management believes will fund operations into the first half of 2027[105][129] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company, as a smaller reporting entity, is not required to provide quantitative and qualitative disclosures regarding market risk - As a smaller reporting company, Aura Biosciences is not required to provide quantitative and qualitative disclosures about market risk[143] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[145] - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[146] PART II. OTHER INFORMATION This section outlines legal proceedings, risk factors, equity sales, and other required disclosures Item 1. Legal Proceedings As of June 30, 2025, the company is not involved in any legal proceedings that would reasonably be expected to have a material adverse effect on its business - As of June 30, 2025, the company is not involved in any material legal proceedings[148] Item 1A. Risk Factors This section provides a comprehensive overview of material risks, including a history of significant net losses, heavy dependence on its sole product candidate bel-sar, the need for substantial additional capital, and complexities in regulatory approval and commercialization - The company has incurred significant net losses since inception, with an accumulated deficit of $428.7 million as of June 30, 2025, and anticipates continued losses for the foreseeable future[150] - The company's business is heavily dependent on the successful development, regulatory approval, and commercialization of its only product candidate, bel-sar[164] - Substantial additional capital will be required to finance operations. The company's existing cash is expected to fund operations into the first half of 2027, but it will not be sufficient to fund bel-sar through regulatory approval[154][155] - The company relies on third parties, such as CROs and CDMOs, to conduct clinical trials and manufacture bel-sar, which increases risks related to performance, compliance, and supply chain disruptions[219][223] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities occurred during the reporting period - There were no unregistered sales of equity securities during the quarter[364] Item 3. Defaults Upon Senior Securities This item is not applicable to the company - Not applicable[367] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[368] Item 5. Other Information The company discloses that no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[369] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, warrant forms, compensation policies, and required certifications - The report includes a list of filed exhibits, such as corporate governance documents, warrant forms, and required CEO/CFO certifications[370]