Q32 Bio Off-Drug Data Supports Bempikibart Maintenance

The Tip Desk · November 4, 2026 · 4 min read

Cash reached $289.6 million after a $200.0 million July offering as the company prepared a 2027 registration-directed alopecia areata trial.

Q32 Bio Inc. (QTTB), a clinical-stage biotechnology company developing therapies for alopecia areata, presented additional 36-week results and 16-week off-drug findings from Part B of the SIGNAL-AA trial of bempikibart at EADV Congress 2026, data the company said support further development of the antibody as a chronic treatment.

Part B is an open-label Phase 2a study in 33 patients with severe or very severe alopecia areata. Patients received bempikibart for 36 weeks, then a 16-week off-drug follow-up before optional enrollment in an open-label extension. At Week 36, the mean percent reduction in Severity of Alopecia Tool score from baseline was 35.3% in the prespecified modified intent-to-treat analysis. Forty percent of patients achieved a SALT-20 response (80% scalp hair coverage) in that analysis, and 30.3% did so in the intent-to-treat analysis of all enrolled patients.

Those Week 36 topline figures had already been announced in July. The new EADV material added the off-drug period: the company said bempikibart showed durability, including maintenance and deepening of response, through the 16-week off-drug window, supportive of less frequent chronic maintenance dosing after an initial treatment period. Biomarker results and biopsy findings supported the mechanism of action, and the antibody was generally well-tolerated with no new safety signals, the company said.

Chief Executive Officer Jodie Morrison said the data support the potential for less frequent, chronic maintenance dosing and that the company believes bempikibart could become a first-line standard-of-care option in alopecia areata.

The open-label extension remains ongoing, with dosing continuing. Analysis from the 16-week off-drug period and the extension is intended to inform long-term chronic maintenance regimens that could include monthly, bi-monthly or quarterly dosing in future studies. Q32 Bio anticipates Part B extension data in the second half of 2027.

A registration-directed program evaluating bempikibart in patients with severe or very severe alopecia areata is expected to initiate in the first half of 2027, subject to planned regulatory discussions in the fourth quarter of 2026. The same first-half 2027 start had already been stated in the prior quarter’s update. The company also said it is evaluating bempikibart in expanded alopecia areata populations and additional immunology and inflammation indications.

In September 2026 the company appointed José Trevejo, M.D., Ph.D., as Chief Medical Officer and Ellie Hershberger, Pharm.D., as Chief Development Officer, and added senior leaders in clinical operations, clinical strategy, medical affairs and regulatory affairs. A half-life-extended anti-IL-7Rα candidate, ADX-914-XL, continues in preclinical development.

Cash and cash equivalents were $289.6 million as of September 30, 2026, up from $106.3 million as of June 30, 2026, after a public offering of common stock and pre-funded warrants that raised approximately $200.0 million in gross proceeds in July. The company said that cash is expected to fund operations through topline Phase 3 results from the planned registration-directed program. Venture debt was zero at September 30, versus $9.7 million at year-end 2025.

Research and development expenses were $5.1 million for the three months ended September 30, 2026, versus $3.6 million a year earlier, which the company attributed primarily to higher bempikibart clinical and manufacturing costs and ADX-914-XL preclinical work. General and administrative expenses were $5.5 million, versus $4.0 million, attributed primarily to higher stock-based compensation and other employee-related costs.

Net loss was $8.9 million, or $0.26 basic and diluted a share, for the three months ended September 30, 2026, compared with $7.4 million, or $0.60 a share, a year earlier. Weighted-average common shares were 34.0 million, versus 12.2 million. Other income, net was $1.7 million, versus $0.2 million.

Morrison said the company is well positioned to advance into a registration-directed program in severe or very severe alopecia areata in the first half of 2027 following planned regulatory discussions this quarter, as well as in other autoimmune and inflammatory indications.