Q32 Bio Inc.(QTTB) - 2025 Q2 - Quarterly Results

Corporate Update and Business Highlights Q32 Bio advanced bempikibart development for alopecia areata with ongoing Phase 2a dosing, a new interim CMO, and FDA Fast Track designation Clinical Program Updates Bempikibart's SIGNAL-AA Phase 2a trial continues patient dosing in Part B and OLE, with Part B topline data expected in H1 2026 - Dosing of patients in Part B of the SIGNAL-AA Phase 2a clinical trial is ongoing, with topline data readout on track for the first half of 2026[1][3] - The Part B trial will evaluate bempikibart in approximately 20 patients with severe AA over a 36-week dosing period, with efficacy measured by changes in SALT scores[3] - Patient dosing is also ongoing in the Part A open-label extension (OLE), initiated due to emerging data suggesting durable responses and strong patient demand for continued treatment[6] Corporate Developments Q32 Bio appointed Dr. Adrien Sipos as Interim CMO and secured FDA Fast Track designation for bempikibart in alopecia areata - Appointed Adrien Sipos, M.D., Ph.D., a seasoned Immunology and Inflammation (I&I) drug developer, as Interim Chief Medical Officer[1][2][6] - Bempikibart received FDA Fast Track designation, potentially allowing more frequent FDA interactions, rolling review, and eligibility for Accelerated Approval and Priority Review[6] Financial Results Q32 Bio reported a reduced net loss of $9.5 million in Q2 2025, driven by lower R&D, with $54.8 million cash extending its runway to 2027 Financial Performance Summary Q32 Bio's cash and equivalents totaled $54.8 million, funding operations into 2027, with reduced R&D and G&A expenses narrowing net loss to $9.5 million - Cash and cash equivalents were $54.8 million as of June 30, 2025, expected to fund operations into 2027 through key clinical milestones for bempikibart[1][6] Expense Summary (in millions USD) | Expense Category | Q2 2025 (USD) | Q2 2024 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | R&D Expenses | $5.2M | $13.4M | -$8.2M | | G&A Expenses | $4.0M | $4.5M | -$0.5M | - The decrease in R&D expenses was primarily due to lower costs for bempikibart development and the discontinuation of the ADX-097 Phase 2 trial, while G&A decreased mainly due to lower personnel and legal costs following restructuring[6][7] Net Loss Summary (in millions USD, except per share) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $9.5M | $17.0M | | Net Loss Per Share (basic & diluted) | $0.78 | $1.42 | Condensed Consolidated Statements of Operations Total operating expenses decreased to $9.2 million in Q2 2025 from $17.9 million in Q2 2024, resulting in a reduced net loss of $9.5 million Condensed Consolidated Statements of Operations (in thousands USD, except per share amounts) | (in thousands, except per share amounts) | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | | Research and development | $5,161 | $13,411 | | General and administrative | $4,010 | $4,508 | | Total operating expenses | $9,171 | $17,919 | | Loss from operations | ($9,171) | ($17,919) | | Net loss | ($9,489) | ($16,978) | | Net loss per share—basic & diluted | ($0.78) | ($1.42) | Condensed Consolidated Balance Sheets As of June 30, 2025, total assets were $66.1 million, down from $92.3 million in 2024, with total liabilities at $78.4 million and a stockholders' deficit of $12.2 million Condensed Consolidated Balance Sheets (in thousands USD) | (in thousands) | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $54,832 | $77,965 | | Total assets | $66,117 | $92,332 | | Liabilities and Stockholders' Equity (Deficit) | | | | Total Liabilities | $78,352 | $86,657 | | Stockholders' equity (deficit) | ($12,235) | $5,675 | | Total liabilities and stockholders' equity (deficit) | $66,117 | $92,332 |