Q32 Bio Announces Q3 2024 Financial Results and Corporate Update

Q32 Bio Inc., a biotechnology firm specializing in the development of biological therapeutics to restore immune balance, announced its financial results for the quarter ending September 30, 2024, along with recent corporate updates. The company made significant progress in its clinical trials and corporate activities.

Q32 Bio is advancing two Phase 2 clinical trials of bempikibart for atopic dermatitis (AD) and alopecia areata (AA). Both trials are on schedule, with topline results expected in December 2024. Bempikibart is an anti-IL-7Rα antibody designed to regulate adaptive immune function by inhibiting IL-7 and TSLP signaling, which contributes to inflammation in autoimmune disorders. The trial for AD, named SIGNAL-AD, is a two-part, randomized, double-blind, placebo-controlled study. Part A, aimed at evaluating safety and enabling dose selection, has been completed, though the data remains blinded. Part B is focused on assessing the efficacy and safety of bempikibart compared to a placebo. In this phase, patients were split evenly between the bempikibart and placebo groups for 12 weeks of treatment. The primary outcome measure is the change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score. A total of 121 patients were enrolled, surpassing the initial target due to high demand.

For AA, the SIGNAL-AA Phase 2 trial is also a randomized, double-blind, placebo-controlled study. Patients with severe AA were randomized in a 3:1 ratio to receive either bempikibart or a placebo for 24 weeks. The primary endpoint is the change from baseline on the Severity of Alopecia Tool (SALT) score at week 24. Patients will be monitored for an additional 12 weeks after treatment.

In addition to these trials, Q32 Bio is conducting a Phase 2 basket trial of ADX-097 for complement-mediated renal diseases. The trial is evaluating the safety, pharmacodynamics, pharmacokinetics, and clinical activity of ADX-097 in patients with IgA Nephropathy (IgAN), Lupus Nephritis (LN), or C3 Glomerulopathy (C3G). Initial open-label data is anticipated in the first half of 2025, with topline results expected in the second half of 2025. Q32 Bio also plans a Phase 2 trial of ADX-097 in ANCA-Associated Vasculitis (AAV) to begin in the first half of 2025, with results expected in the second half of the year.

Positive results from the Phase 1 trial of ADX-097 were presented at ASN Kidney Week 2024. The first-in-human trial in healthy volunteers demonstrated a favorable safety profile and promising pharmacokinetic and pharmacodynamic properties, supporting the planned doses for Phase 2 trials.

Financially, Q32 Bio reported cash and cash equivalents of $89.1 million as of September 30, 2024, which is expected to fund operations through four Phase 2 clinical milestones into mid-2026. Research and development expenses for the three months ended September 30, 2024, were $14.3 million, up from $7.5 million in the same period in 2023. This increase was primarily due to higher clinical trial and manufacturing costs for the Phase 2 trials of bempikibart and included a $4.0 million milestone payment to Bristol-Myers Squibb. General and administrative expenses rose to $4.5 million from $2.2 million, mainly due to increased stock-based compensation, consulting, and public company-related costs. The net loss for the quarter was $17.6 million, or $1.46 per share, compared to a net loss of $14.0 million, or $40.52 per share, for the same period in 2023.

Q32 Bio is committed to developing therapeutics that target key regulators of the immune system to treat autoimmune and inflammatory diseases. The company's lead programs focus on the IL-7/TSLP receptor pathways and the complement system, aiming to help patients regain control of their lives.