Q32 Bio Inc.(US:QTTB)2025-08-06 11:08PART I—FINANCIAL INFORMATION Financial Statements (Unaudited) The unaudited statements show a clinical-stage company with no revenue, a net loss of $20.5 million, and the financial impact of a recent merger Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $54,832 | $77,965 | | Total assets | $66,117 | $92,332 | | Total liabilities | $78,352 | $86,657 | | Total stockholders' equity (deficit) | $(12,235) | $5,675 | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $12,286 | $23,252 | | General and administrative | $9,114 | $9,510 | | Loss from operations | $(21,400) | $(32,762) | | Net loss | $(20,520) | $(15,949) | | Net loss per share—basic | $(1.68) | $(2.46) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Account | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,133) | $(36,765) | | Net cash provided by investing activities | $0 | $9,985 | | Net cash provided by financing activities | $0 | $93,824 | | Net (decrease) increase in cash | $(23,133) | $67,044 | - The company completed a reverse recapitalization merger with Homology Medicines, Inc. on March 25, 2024, which included a $42.0 million Pre-Closing Financing323334 - As of June 30, 2025, the company had $54.8 million in cash and cash equivalents and an accumulated deficit of $255.3 million, with management believing cash is sufficient for at least one year39 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses its strategic focus on bempikibart, the financial impact of its recent merger, and its current liquidity position and future capital needs - The company is advancing bempikibart for Alopecia Areata (AA) after completing a Phase 2a trial, with topline data expected in H1 2026 and an FDA Fast Track designation162166167 - A strategic restructuring in February 2025 discontinued the ADX-097 trial to focus on bempikibart, resulting in severance-related charges of approximately $0.9 million171 Comparison of Results of Operations (in thousands) | Period | Research & Development Expense | General & Administrative Expense | Net Loss | | :--- | :--- | :--- | :--- | | Three Months Ended June 30, 2025 | $5,161 | $4,010 | $(9,489) | | Three Months Ended June 30, 2024 | $13,411 | $4,508 | $(16,978) | | Six Months Ended June 30, 2025 | $12,286 | $9,114 | $(20,520) | | Six Months Ended June 30, 2024 | $23,252 | $9,510 | $(15,949) | - The decrease in R&D expenses was primarily due to lower clinical and manufacturing costs for the bempikibart program and the discontinuation of the ADX-097 trial199205 - The company's $54.8 million in cash and cash equivalents is expected to fund operations into 2027, but substantial additional capital will be needed for future development180213 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the company is not required to provide disclosures about market risk - As a smaller reporting company, Q32 Bio Inc. is not required to provide quantitative and qualitative disclosures about market risk246 Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Management evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and concluded they were effective248 - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025249 PART II—OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings - As of the report date, the company is not involved in any material legal proceedings251 Risk Factors The company faces significant risks including a history of losses, capital requirements, dependence on its lead product, and regulatory challenges - The company has a history of significant losses ($20.5 million for H1 2025), has no products for sale, and may never achieve profitability253254 - Substantial additional capital is required to finance future operations beyond the current cash runway projected into 2027258259 - The company is substantially dependent on the success of its most advanced product candidate, bempikibart, whose clinical trials may not be successful272 - The company's ability to protect its patents is uncertain and it relies on key licenses from third parties like Bristol-Myers Squibb298306 - The company relies on third parties for manufacturing and clinical trials, including foreign CDMOs like WuXi Biologics which could be impacted by the BIOSECURE Act395406410 - The company received a Nasdaq non-compliance notice on May 19, 2025, for failing to meet the minimum stockholders' equity requirement, which could result in delisting467 Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the covered period - The company reports no unregistered sales of equity securities for the period covered by the report483 Defaults Upon Senior Securities The company reports no defaults upon senior securities during the period - The company reports no defaults upon senior securities484 Mine Safety Disclosures This item is not applicable as the company is not engaged in mining operations - Mine safety disclosures are not applicable to the company's operations485 Other Information No Rule 10b5-1 trading plans were adopted, modified, or terminated by officers or directors during the quarter - No officers or directors adopted, modified, or terminated any Rule 10b5-1 trading plans during the quarter ended June 30, 2025486 Exhibits This section lists exhibits filed with the Form 10-Q, including merger agreements and officer certifications - The report includes a list of filed exhibits, such as the Merger Agreement, corporate governance documents, and Sarbanes-Oxley Act certifications488