Homology(FIXX) - 2025 Q2 - Quarterly Results

Second Quarter 2025 and Recent Business Highlights Q32 Bio advanced bempikibart development, with SIGNAL-AA trial Part B topline data expected 1H 2026, and received Fast Track designation - 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; Part B will evaluate bempikibart in approximately 20 evaluable patients with severe or very severe AA for 36 weeks[3][4] - Dosing of patients in Part A OLE of the SIGNAL-AA Phase 2a clinical trial is ongoing, initiated due to continued emergence of bempikibart data suggesting a remittive effect and durable responses[6] - Adrien Sipos, M.D., Ph.D., an immunologist and seasoned Immunology and Inflammation (I&I) drug developer, was appointed as Interim Chief Medical Officer[1][6] - Fast Track designation (FTD) was granted to bempikibart for the treatment of AA, designed to facilitate development and expedite review of new drugs for serious diseases with unmet medical needs[6] Financial Runway Update Q32 Bio reported $54.8 million in cash and cash equivalents as of June 30, 2025, extending its financial runway into 2027, covering key clinical milestones Cash and Cash Equivalents | Metric | Value (as of June 30, 2025) | | :----- | :-------------------------- | | Cash and cash equivalents | $54.8 million | - Q32 Bio believes its cash and cash equivalents are sufficient to fund operations into 2027, through the SIGNAL-AA OLE and topline results of the SIGNAL-AA Part B trial[6] Financial Results Operating Expenses Operating expenses significantly decreased in Q2 2025 versus Q2 2024, driven by lower bempikibart development, reduced ADX-097 expenses, and lower personnel and legal costs post-restructuring Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) (in thousands) | | :--------------- | :--------------------- | :--------------------- | :-------------------------- | | Research and development | $5,161 | $13,411 | -$8,250 | | General and administrative | $4,010 | $4,508 | -$498 | | Total operating expenses | $9,171 | $17,919 | -$8,748 | - The decrease in R&D expenses was primarily due to lower bempikibart development costs (clinical and manufacturing), lower direct R&D expenses related to ADX-097, and lower personnel-related costs due to the discontinuation of the ADX-097 Phase 2 clinical trial and restructuring announced in February 2025[6] - The decrease in G&A expenses was primarily due to lower personnel-related costs as a result of reduced headcount associated with the restructuring in February 2025, as well as lower legal costs[7] Net Loss and EPS Q32 Bio reported a net loss of $9.5 million or $0.78 per share for Q2 2025, a significant improvement from $17.0 million or $1.42 per share in Q2 2024 Net Loss and EPS (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net loss | $(9.5) million | $(17.0) million | $(7.5) million decrease | | Net loss per share (basic & diluted) | $(0.78) | $(1.42) | $(0.64) decrease | About Q32 Bio Company Overview and Therapeutic Focus Q32 Bio is a clinical-stage biotechnology company developing innovative therapies for autoimmune and inflammatory diseases, especially alopecia areata, with lead candidate bempikibart in a Phase 2 program - Q32 Bio is a clinical stage biotechnology company whose science targets potent regulators of the adaptive immune system to re-balance immunity, focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases[8] - Bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function, is being advanced for the treatment of alopecia areata in an ongoing Phase 2 program[8] - Approximately 700,000 people in the United States live with alopecia areata, a disease with a life-altering impact and limited current treatment options[8] Forward-Looking Statements Disclaimer and Risk Factors This section outlines Q32 Bio's forward-looking statements regarding clinical trials, product efficacy, regulatory processes, financial runway, and business plans, all subject to inherent risks and uncertainties - This communication contains forward-looking statements regarding Q32 Bio's beliefs, observations, expectations, and assumptions concerning clinical trials (SIGNAL-AA Part B timing and data), bempikibart's safety, efficacy, and benefits, FTD benefits, leadership appointments, and financial runway into 2027[10][11] - Forward-looking statements are based on management's current beliefs and assumptions, but are subject to risks and uncertainties, including that additional data may not support current beliefs, clinical studies may not be completed as anticipated or yield expected results, FTD may not accelerate processes, and capital resources may be used sooner than expected[12] Contacts Investor and Media Relations This section provides contact information for investor and media inquiries, directed to Argot Partners - Investor contact: Brendan Burns, Argot Partners, 212.600.1902, Q32Bio@argotpartners.com[13] - Media contact: David Rosen, Argot Partners, 646.461.6387, david.rosen@argotpartners.com[13] Condensed Consolidated Financial Statements Condensed Consolidated Statements of Operations The Condensed Consolidated Statements of Operations show a net loss of $9.5 million for Q2 2025, an improvement from $17.0 million in the prior year, due to reduced operating expenses Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $5,161 | $13,411 | $12,286 | $23,252 | | General and administrative | $4,010 | $4,508 | $9,114 | $9,510 | | Total operating expenses | $9,171 | $17,919 | $21,400 | $32,762 | | Loss from operations | $(9,171) | $(17,919) | $(21,400) | $(32,762) | | Net loss | $(9,489) | $(16,978) | $(20,520) | $(15,949) | | Net loss per share—basic | $(0.78) | $(1.42) | $(1.68) | $(2.46) | | Net loss per share—diluted | $(0.78) | $(1.42) | $(1.68) | $(4.44) | Condensed Consolidated Balance Sheets The Condensed Consolidated Balance Sheets show cash and cash equivalents decreased to $54.8 million as of June 30, 2025, from $78.0 million at December 31, 2024, with total assets decreasing and stockholders' equity shifting to a deficit Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change (in thousands) | | :-------------------- | :------------ | :---------------- | :-------------------- | | Cash and cash equivalents | $54,832 | $77,965 | -$23,133 | | Total assets | $66,117 | $92,332 | -$26,215 | | Stockholders' equity (deficit) | $(12,235) | $5,675 | -$17,9