Q32 BIO INC Stock Price, News & Analysis

Q32 Bio (Nasdaq: QTTB) reported third-quarter 2025 results and clinical updates on bempikibart in alopecia areata (AA). The company completed enrollment in Part B of the SIGNAL-AA Phase 2a trial and increased the cohort to 33 patients, with topline data expected in mid-2026. Part B uses a 200 mg loading regimen then 200 mg every-other-week for 36 weeks; follow-up extends to 52 weeks. Preliminary PK shows steady state reached ≥9 weeks earlier versus Part A. Part A open-label extension dosing is ongoing. Cash and cash equivalents were $49.0 million as of September 30, 2025, expected to fund operations into 2027.

Q32 Bio (NASDAQ: QTTB) completed enrollment in Part B of its SIGNAL-AA Phase 2a trial of bempikibart for severe or very severe alopecia areata on Oct 21, 2025. Total enrollment reached 33 patients, exceeding an initial ~20-patient target due to patient demand. Part B uses a 200mg loading regimen (weekly x4) then 200mg every-other-week to 36 weeks, with follow-up to 52 weeks.

Early-enrolling patients show emerging clinical activity; preliminary PK indicates steady state is achieved about 9 weeks earlier versus Part A. Topline data are expected in mid-2026.

Q32 Bio (Nasdaq: QTTB), a clinical stage biotech company developing therapies for alopecia areata and other autoimmune and inflammatory diseases, will participate in the 2025 Wells Fargo Healthcare Conference. The company's management will engage in a fireside chat on September 4th at 3:45 p.m. E.T.

Investors can access the presentation through a webcast on Q32 Bio's website, with replays available for 90 days after the event.

Q32 Bio (NASDAQ: QTTB) has reported its Q2 2025 financial results and provided corporate updates. The company continues to advance its bempikibart development program for alopecia areata (AA), with patient dosing ongoing in both Part A open-label extension (OLE) and Part B of the SIGNAL-AA Phase 2a clinical trial. The company has appointed Dr. Adrien Sipos as Interim Chief Medical Officer and received Fast Track designation for bempikibart.

Q32 Bio reported cash and cash equivalents of $54.8 million as of June 30, 2025, extending their runway into 2027. The company's R&D expenses decreased to $5.2 million from $13.4 million year-over-year, while G&A expenses reduced to $4.0 million. Net loss improved to $9.5 million ($0.78 per share) compared to $17.0 million in Q2 2024.

Q32 Bio (NASDAQ:QTTB) has appointed Dr. Adrien Sipos as Interim Chief Medical Officer, succeeding Dr. Jason Campagna. Dr. Sipos, an immunologist with over 25 years of experience in clinical development and medical affairs, joins at a crucial time as the company advances its SIGNAL-AA Phase 2a clinical trial of bempikibart for alopecia areata.

Dr. Sipos previously served as President and CMO at PRAXICO Inc. and held leadership positions at Biogen, Sanofi Genzyme, and Eli Lilly. The company expects topline results from the Part B portion of the SIGNAL-AA trial in the first half of 2026. Bempikibart, their lead candidate, is a human anti-IL-7Rα antibody targeting IL-7 and TSLP signaling for autoimmune and inflammatory diseases.

Q32 Bio (NASDAQ: QTTB) reported its Q1 2025 financial results and provided key updates on bempikibart, its treatment for alopecia areata (AA). The company achieved several milestones, including Fast Track designation from the FDA and dosing the first patients in both Part B of the SIGNAL-AA Phase 2a trial and the Part A open-label extension. The company presented promising results at the AAD Annual Meeting, showing continued efficacy after treatment cessation.

Financial highlights include $65.5 million in cash as of March 31, 2025, providing runway into 2H'26. Q1 2025 saw reduced R&D expenses of $7.1 million (down from $9.8 million in Q1 2024), while G&A expenses remained stable at $5.1 million. The company reported a net loss of $11.0 million ($0.90 per share) compared to net income of $1.0 million in Q1 2024.

Q32 Bio has received FDA Fast Track designation for its drug bempikibart (ADX-914) to treat alopecia areata. Bempikibart, a human anti-IL-7Rα antibody that blocks IL-7 and TSLP signaling, is currently in Phase 2 trials through the SIGNAL-AA clinical program.

The Fast Track status acknowledges both the serious nature of alopecia areata and the significant unmet medical needs in this field. This designation follows promising clinical activity in Part A of the SIGNAL-AA trial, with dosing now initiated in both Part A's open-label extension and Part B.

The Fast Track process aims to speed up drug development and review, potentially offering benefits like more frequent FDA communications, rolling review opportunities, and possible eligibility for Accelerated Approval and Priority Review, helping bring crucial treatments to patients faster.

Q32 Bio (QTTB) has announced significant progress in its SIGNAL-AA Phase 2a clinical trial for bempikibart in alopecia areata (AA) treatment. The company has dosed first patients in both Part A open-label extension (OLE) and Part B of the trial.

Part A results showed encouraging clinical activity with improvement in SALT scores and SALT-20 responses through week 36. Notable continued responses were observed in multiple patients through week 55, approximately seven months post-last dose, suggesting potential remittive effects and durability of response.

Part B will evaluate approximately 20 severe or very severe AA patients over 36 weeks, with follow-up to 52 weeks. The treatment protocol includes a 200mg weekly loading regimen for four weeks, followed by 200mg every-other-week maintenance doses over 32 weeks. Topline data from Part B is expected in the first half of 2026.

Q32 Bio (QTTB) has reported its Q4 2024 financial results and provided corporate updates. The company presented encouraging Phase 2a Part A data for bempikibart in treating alopecia areata (AA) at the 2025 AAD Annual Meeting. The drug demonstrated meaningful clinical activity at week 24 with continued effects after dosing cessation, showing potential as a differentiated AA treatment.

Key financial metrics include cash and equivalents of $78.0 million as of December 31, 2024, providing runway into 2H'26. Q4 2024 saw R&D expenses of $10.5 million (up from $8.3M YoY) and G&A expenses of $4.0 million (up from $2.8M YoY). Net loss was $14.2 million ($1.16 per share).

The company is advancing two key initiatives: the SIGNAL-AA open-label extension and SIGNAL-AA Part B, both scheduled to dose patients in 1H'25, with Part B topline data expected in 1H'26.