Clinical Trial Results - The SIGNAL-AA Phase 2a trial studied bempikibart in patients with severe or very severe Alopecia Areata [1] - The study included patients with SALT scores between 50 and 100 [15] - At Week 24, patients with baseline SALT 50-100 showed a mean SALT score change of 163% with bempikibart treatment [20] - In patients with baseline SALT 50-95, the mean SALT score change at Week 24 was 245% with bempikibart [20] - Some patients experienced continued response even 7 months post last dose [23, 24] Safety and Tolerability - In the bempikibart group, 70% of participants experienced at least one treatment-emergent adverse event (TEAE) [27] - In the placebo group, 38% of participants experienced at least one TEAE [27] - No Grade 3 or higher related adverse events were reported in the bempikibart group [27] Study Design and Demographics - The study randomized patients in a 3:1 ratio to bempikibart (n=33) or placebo (n=81) [15] - The mean baseline SALT score in the bempikibart group was 749, while in the placebo group it was 819 [16]

Core Insights - Q32 Bio Inc. has appointed Dr. Adrien Sipos as Interim Chief Medical Officer, succeeding Dr. Jason Campagna, who is leaving the company [1][2] - Dr. Sipos brings over 25 years of experience in clinical development and medical affairs, particularly in Immunology and Inflammation [1][2] - The company is advancing its Phase 2a clinical trial for bempikibart, a treatment for alopecia areata, with topline results expected in the first half of next year [2][3] Company Overview - Q32 Bio is a clinical stage biotechnology company focused on developing therapies for alopecia areata and other autoimmune and inflammatory diseases [3] - Approximately 700,000 individuals in the U.S. are affected by alopecia areata, which significantly impacts their lives and has limited treatment options [3] - Bempikibart (ADX-914) is a fully human anti-IL-7Rα antibody that aims to re-regulate adaptive immune function and is currently in a Phase 2 program [3] Leadership Background - Dr. Sipos previously served as President and Chief Medical Officer at PRAXICO Inc., advising biopharmaceutical companies on clinical development [2] - She has held significant roles at Biogen, Sanofi Genzyme, and Eli Lilly, focusing on immunology and clinical development [2] - Dr. Sipos holds a Ph.D. in Clinical Immunology and an M.D. specializing in clinical immunology and endocrine care [2]

-- First patient dosed in SIGNAL-AA Phase 2a Part B; topline data readout on-track for 1H'26 ---- First patient dosed in SIGNAL-AA Part A open-label extension (OLE) ---- Fast Track designation (FTD) granted to bempikibart for the treatment of alopecia areata (AA); SIGNAL-AA Part A results presented as a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting ---- Cash and cash equivalents of $65.5 million as of March 31, 2025 expected to provide financial runway into ...

-- 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 ...

-- 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 - 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]