Q32 Bio Announces Q1 2024 Financial Results and Corporate Update

Q32 Bio Inc., a clinical-stage biotech company specializing in biologic therapeutics to restore immune balance, has reported its financial results and recent corporate updates for the quarter ending March 31, 2024. The company achieved significant milestones in its ongoing clinical trials and corporate restructuring.

The first quarter of 2024 marked a pivotal period for Q32 Bio, highlighted by its transition to a public company and substantial progress in its pipeline programs. Chief Executive Officer Jodie Morrison emphasized the strides made in the company's Phase 2 clinical trials for bempikibart, targeting alopecia areata (AA) and atopic dermatitis (AD). Enrollment for the AA trial is complete, and topline results are expected in the fourth quarter of 2024. The AA trial involves approximately 40 patients with severe AA, treated with either bempikibart or a placebo, with the primary endpoint being the mean percent change in the Severity of Alopecia Tool (SALT) score after 24 weeks. Patients will continue to be monitored for an additional 12 weeks post-treatment.

Similarly, the Phase 2 trial for AD remains on track, with topline results also anticipated in the fourth quarter of 2024. This trial includes about 100 patients and consists of two parts. Part A, which has been completed, evaluated safety and pharmacokinetics to inform dose selection for Part B. In Part B, patients are randomly assigned to receive either bempikibart or a placebo over 12 weeks, with the primary endpoint being the mean percent change in the Eczema Area and Severity Index (EASI) score from baseline to week 14. Follow-up will continue for an additional 12 weeks post-treatment.

In addition, Q32 Bio is advancing ADX-097, its leading complement inhibitor candidate, designed to offer tissue-targeted regulation without long-term systemic effects. The company plans to initiate a Phase 2 renal basket trial in the first half of 2024 and a Phase 2 trial for ANCA-associated vasculitis (AAV) in the first half of 2025. Topline results for both trials are expected in the second half of 2025, with initial renal basket data projected by the end of 2024.

The company also highlighted the recent appointment of Lee Kalowski as President and Chief Financial Officer. Kalowski brings over two decades of biopharmaceutical experience, focusing on strategic planning, capital raising, and financial operations. Additionally, the board of directors has been strengthened with the inclusion of industry veterans Mary Thistle and Arthur Tzianabos, Ph.D.

In March 2024, Q32 Bio completed a reverse merger with Homology Medicines, Inc., along with a concurrent private placement of $42 million. Following this merger, Q32 Bio began trading on the Nasdaq Global Market under the ticker "QTTB." As of March 31, 2024, the company's cash, cash equivalents, and short-term investments totaled $135.3 million, expected to fund operations through mid-2026.

The financial performance for the first quarter of 2024 showed research and development expenses of $9.8 million, up from $7.9 million in the same period the previous year, primarily due to increased clinical trial and manufacturing costs. General and administrative expenses also rose to $5.0 million from $2.4 million, mainly due to costs associated with the reverse merger.

Net income for the quarter was $1.0 million, compared to a net loss of $6.8 million in the first quarter of 2023. This turnaround was largely due to a $15.9 million gain on the conversion of convertible notes upon closing the reverse merger.

Q32 Bio continues to focus on developing treatments that address immune dysregulation in autoimmune and inflammatory diseases. Its lead programs, targeting the IL-7/TSLP receptor pathways and complement system, aim to help patients regain control of their immune health. The company's strategic plans and recent financial and clinical milestones position it well as it advances its pipeline and expands its operations.