Q32 Bio Inc.(QTTB) - 2025 Q1 - Quarterly Results

Corporate Update and Business Highlights This section details Q32 Bio's progress with its lead candidate bempikibart, including clinical trial advancements and positive Phase 2a results Bempikibart Program Advancements Q32 Bio advanced its bempikibart program for alopecia areata, dosing the first patient in Phase 2a Part B and receiving FDA Fast Track designation - The first patient has been dosed in Part B of the SIGNAL-AA Phase 2a clinical trial, with topline data expected in the first half of 2026[1][4] - Bempikibart received Fast Track designation (FTD) from the FDA for the treatment of alopecia areata, a status intended to facilitate development and expedite the review of drugs for serious conditions[1][3] - The first patient was dosed in the open-label extension (OLE) for eligible patients who completed Part A of the SIGNAL-AA trial, allowing for longer-term follow-up[1][4] SIGNAL-AA Phase 2a Part A Trial Results Part A of the SIGNAL-AA Phase 2a trial showed clinically meaningful activity and a deepening response post-treatment, with bempikibart demonstrating safety and tolerability - In the SIGNAL-AA Part A trial, bempikibart showed clinically meaningful activity at week 24, with responses continuing to improve after dosing ceased, through the week 36 follow-up period[4] - Among 12 patients who responded during the trial, all maintained their response or showed further hair growth post-treatment, with seven showing additional hair growth by SALT assessment[4] - Across clinical trials, bempikibart was observed to be safe and well-tolerated, with no grade 3 or higher related adverse events or related viral infections reported[5] Financial Results This section provides an overview of Q32 Bio's first quarter 2025 financial performance, including net loss, cash position, and key financial statements First Quarter 2025 Financial Summary Q32 Bio reported a net loss of $11.0 million for Q1 2025, with $65.5 million in cash expected to fund operations into the second half of 2026 - Cash and cash equivalents were $65.5 million as of March 31, 2025, which is expected to provide financial runway into the second half of 2026[1][8] Q1 2025 vs. Q1 2024 Financial Highlights (in millions) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and Development Expenses | $7.1 | $9.8 | | General and Administrative Expenses | $5.1 | $5.0 | | Net Income (Loss) | $(11.0) | $1.0 | | Net Income (Loss) Per Share (Basic) | $(0.90) | $1.03 | Condensed Consolidated Statements of Operations Q32 Bio reported a net loss of $11.0 million for Q1 2025, a shift from a $1.0 million net income in Q1 2024, primarily due to a non-recurring gain in the prior year Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2025 | 2024 | | Total operating expenses | $12,228 | $14,843 | | Loss from operations | $(12,228) | $(14,843) | | Change in fair value of convertible notes | — | $15,890 | | Net income (loss) | $(11,031) | $1,029 | | Net income (loss) per share—basic | $(0.90) | $1.03 | Condensed Consolidated Balance Sheets As of March 31, 2025, Q32 Bio's total assets decreased to $79.1 million, primarily due to reduced cash, resulting in a stockholders' deficit of $4.0 million Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $65,483 | $77,965 | | Total assets | $79,071 | $92,332 | | Liabilities and stockholders' equity (deficit) | | | | Total liabilities | $83,085 | $86,657 | | Stockholders' equity (deficit) | $(4,014) | $5,675 | | Total liabilities and stockholders' equity (deficit) | $79,071 | $92,332 | Company Information and Forward-Looking Statements This section provides an overview of Q32 Bio's focus on autoimmune and inflammatory diseases and outlines the forward-looking nature of the report's statements About Q32 Bio Q32 Bio is a clinical-stage biotechnology company developing therapies for autoimmune and inflammatory diseases, with bempikibart as its lead candidate for alopecia areata - Q32 Bio is a clinical-stage biotechnology company developing therapies for alopecia areata and other autoimmune and inflammatory diseases[7] - The company's lead candidate is bempikibart (ADX-914), an anti-IL-7Rα antibody being advanced for the treatment of alopecia areata[7] Forward-Looking Statements This report includes forward-looking statements regarding bempikibart's clinical development and financial projections, which are subject to inherent risks and uncertainties - The report contains forward-looking statements regarding the plan and timing of the SIGNAL-AA Phase 2a clinical trial, the potential benefits of bempikibart, and the sufficiency of cash to fund operations into the second half of 2026[10] - Key risks include the possibility that future data may not support current expectations, clinical studies may be delayed or not yield anticipated results, and capital may be used sooner than expected[11]