Q32 Bio Inc.

Q32 Bio Inc. is a clinical-stage biotechnology company focused on developing new biologic treatments to restore healthy immune balance in patients with alopecia areata (AA) and other autoimmune and inflammatory diseases caused by immune dysfunction. The company's most advanced product candidate is Bempikibart (ADX-914), a fully human anti-interleukin-7 receptor alpha (IL-7Rα) antagonist monoclonal antibody. Bempikibart is designed to re-regulate adaptive immune function by blocking signaling from interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP). Q32 Bio Inc. has completed two Phase 2a clinical trials for bempikibart: SIGNAL-AA Part A for AA, and SIGNAL-AD for atopic dermatitis (AD). In December 2024, the company announced topline results from both trials and its plan to advance bempikibart for AA treatment. In April 2025, dosing began for the first patients in both the Part A open-label extension and Part B of the SIGNAL-AA Phase 2a clinical trial. By October 2025, enrollment was completed in SIGNAL-AA Part B, with 33 patients enrolled, and dosing is ongoing. The company expects to report 36-week topline data from SIGNAL-AA Part B in mid-2026. In SIGNAL-AA Part A, 44 patients with severe and very severe AA were enrolled and received 200mg subcutaneous (SC) bempikibart every two weeks for 24 weeks, followed by a 12-week observation period. At the 24-week endpoint, treated patients showed more hair regrowth compared to placebo, with evidence of durable responses. Average hair regrowth continued to improve from week 24 to week 36, even after patients stopped therapy.