UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-38433 (Exact name of Registrant as specified in its Charter) Delaware 47-3468154 Q32 Bio Inc. (S ...

Exhibit 99.1 Q32 Bio Reports Fourth Quarter 2024 Financial Results and Provides Corporate Update -- Presented bempikibart SIGNAL-AA Phase 2a Part A alopecia areata (AA) data demonstrating encouraging clinical activity and highlighting the potential to be a differentiated treatment as a late- breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting -- -- Advancing bempikibart in patients with AA, with SIGNAL-AA open-label extension (OLE) and SIGNAL-AA Part B on track to dos ...

Core Insights - Q32 Bio presented encouraging clinical data for bempikibart in treating alopecia areata (AA) at the 2025 American Academy of Dermatology Annual Meeting, indicating its potential as a differentiated treatment option [1][2][6] - The company is on track to initiate the SIGNAL-AA open-label extension and Part B of the Phase 2a clinical trial in the first half of 2025, with topline data expected in the first half of 2026 [1][6] - As of December 31, 2024, Q32 Bio reported cash and cash equivalents of $78.0 million, which is expected to fund operations into the second half of 2026 [1][4] Clinical Development - Bempikibart, a fully human anti-IL-7Rα antibody, demonstrated clinically meaningful activity in a difficult-to-treat patient population with severe AA, showing continued effects after treatment cessation [6][7] - In the Phase 2a Part A trial, patients exhibited a deepening response in Severity of Alopecia Tool (SALT) scores, with all 12 patients who responded maintaining or achieving further hair growth during the follow-up period [6] - The upcoming SIGNAL-AA Part B trial will involve approximately 20 evaluable patients, with dosing regimens including an initial loading dose of 200mg weekly for four weeks, followed by a maintenance dose every other week [6] Financial Performance - For the quarter ended December 31, 2024, Q32 Bio reported a net loss of $14.2 million, a significant reduction from a net loss of $27.1 million in the same quarter of 2023 [4][12] - Research and development expenses increased to $10.5 million from $8.3 million year-over-year, primarily due to higher clinical trial and manufacturing costs [4][12] - General and administrative expenses rose to $4.0 million from $2.8 million, attributed to increased stock-based compensation and public company-related costs [4][12]

Core Insights - Bempikibart shows promising results in reducing SALT scores in patients with severe alopecia areata, indicating potential for long-term efficacy and safety [1][3][4] Clinical Trial Results - In the Phase 2a clinical trial, bempikibart demonstrated a mean reduction in SALT score of 16% at week 24 compared to a 2% reduction in the placebo group, with a p-value of 0.045 [5][6] - At week 36, patients treated with bempikibart exhibited a mean SALT score reduction of 20%, with a 28% reduction observed in patients with severe disease [7][12] - The trial included 41 patients, with a primary endpoint focused on the mean relative percent change in SALT score at 24 weeks [4] Safety and Tolerability - Bempikibart was well-tolerated, with no Grade 3 or higher adverse events reported, and no related viral infections in the treatment group [8][9] Mechanism of Action - Bempikibart acts as a potent inhibitor of IL-7 and TSLP, leading to significant reductions in Th2 biomarkers and modulation of T-cells [9][10] Future Development Plans - Q32 Bio plans to initiate an open-label extension study in the first half of 2025, along with the SIGNAL-AA Part B trial, which will include a loading dosing regimen [2][14][15] - Topline data from SIGNAL-AA Part B is expected in the first half of 2026, supporting advancement into pivotal trials [2][15]

Core Insights - Q32 Bio Inc. announced the presentation of Phase 2a Part A results of bempikibart for alopecia areata at the 2025 AAD Annual Meeting, highlighting its potential in treating severe cases of the disease [1][2] Group 1: Clinical Trial Details - The SIGNAL-AA Phase 2a clinical trial is a randomized, placebo-controlled study evaluating bempikibart, a fully human anti-IL-7Rα antibody [1][4] - The oral presentation will take place on March 8, 2025, from 10:36 a.m. to 10:48 a.m. ET at Chapin Theater, Level II [2] Group 2: Company Overview - Q32 Bio is a clinical stage biotechnology company focused on developing biologic therapeutics aimed at restoring immune homeostasis in autoimmune and inflammatory diseases [3][4] - Bempikibart is being evaluated for its ability to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling pathways, which are implicated in various autoimmune diseases [4]

Core Insights - Q32 Bio Inc. is a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis [1][2] - The company will participate in two investor conferences in March 2025, providing opportunities for engagement with investors [1] Company Overview - Q32 Bio targets potent regulators of the adaptive immune system to address autoimmune and inflammatory diseases [2] - The company is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody, currently in a Phase 2 program for the treatment of autoimmune diseases [3] Upcoming Events - Q32 Bio will present at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, at 11:50 a.m. E.T. in Boston, MA [1] - The company will also participate in the Leerink Partners Global Healthcare Conference on March 11, 2025, with a fireside chat at 11:20 a.m. E.T. in Miami Beach, FL [1] - Webcasts of the presentations will be available on the company's website, with archived replays for 90 days [1]

Core Viewpoint - Q32 Bio is restructuring to focus on the clinical development of bempikibart for alopecia areata, discontinuing the renal basket trial for ADX-097 to conserve resources and extend cash runway to the second half of 2026 [1][2][3] Bempikibart Development Program - Bempikibart has shown encouraging clinical activity in the SIGNAL-AA Phase 2a trial, with significant improvements in the Severity of Alopecia Tool (SALT) score and a notable response rate (SALT-20) through week 36, with continued responses observed up to week 55 [3][4] - The company plans to initiate an open-label extension (OLE) for eligible patients from Part A and begin dosing in Part B of the SIGNAL-AA trial in the first half of 2025, with topline data expected in the first half of 2026 [2][4][6] ADX-097 and Complement Inhibitor Platform - ADX-097 is a Phase 2 tissue-targeted complement inhibitor with potential applications across various conditions, including renal and autoimmune diseases, but its development is being deprioritized in favor of bempikibart [1][7][8] - The restructuring includes evaluating strategic options for the complement inhibitor platform, which includes ADX-097 and other early-stage assets [1][2] Financial Outlook - The company's cash runway is expected to extend into the second half of 2026 due to cost-saving measures, including personnel reductions [1][2]

Company Overview - Q32 Bio Inc. is a clinical stage biotechnology company focused on developing biologic therapeutics aimed at restoring immune homeostasis in autoimmune and inflammatory diseases [3][4] - The company is developing therapies that target potent regulators of both innate and adaptive immune systems [3] Key Programs - Q32 Bio's lead program, bempikibart (ADX-914), is a fully human anti-IL-7Rα antibody currently in a Phase 2 program, designed to re-regulate adaptive immune function for treating autoimmune diseases [4] - The company is also evaluating ADX-097, a program for innate immunity, in a Phase 2 program, which utilizes a novel platform for tissue-targeted regulation of the complement system [4] Upcoming Events - Management will participate in a virtual presentation at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 4:00 p.m. E.T. [1] - A webcast of the presentation will be available on Q32 Bio's website, with archived replays accessible for 90 days post-event [2]

Core Viewpoint - Q32 Bio (QTTB) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in a company's earnings picture, which is crucial for near-term stock price movements [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Business Outlook for Q32 Bio - The upgrade indicates an improvement in Q32 Bio's underlying business, suggesting that investors may respond positively by pushing the stock price higher [5]. - The Zacks Consensus Estimate for Q32 Bio has increased by 14.1% over the past three months, with expected earnings of -$5.50 per share for the fiscal year ending December 2024, reflecting an 83.2% year-over-year change [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - Q32 Bio's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Viewpoint - Q32 Bio's shares plummeted nearly 77% following mixed results from two Phase IIa studies for its drug bempikibart, leading to a decision to focus on alopecia areata while discontinuing eczema development [1][2][3] Group 1: Study Results - The alopecia areata study showed a 16% mean reduction in the Severity of Alopecia Tool (SALT) score for patients treated with bempikibart, compared to a 2% reduction in the placebo group [5] - In the eczema study, 76% of placebo recipients showed improvement versus 74% in the bempikibart group, indicating a lack of efficacy for the drug in this indication [7][8] - Management plans to enroll around 20 additional patients for a Part B expansion of the alopecia areata study due to unforeseen participant dropouts [6] Group 2: Stock Performance - Following the announcement, Q32 Bio's stock hit an all-time low of $5.80, reflecting investor concerns about the drug's efficacy [3] - Year-to-date, Q32 Bio's shares have declined by 45.6%, contrasting with an 8.7% decline in the industry [3]