-- SIGNAL-AA Part B topline data readout on-track for 1H'26 -- WALTHAM, Mass., April 16, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio" or the "Company"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases, today announced that the Company has dosed the first patients in both the Part A open-label extension (OLE) and Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients ...

Q32 Bio (QTTB) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changing earnings picture is ...

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 ...

-- 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 dose patients in 1H'25; SIGNAL-AA Part B topline data on-track for 1H'26 -- -- Cash and cash equivale ...

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]