Q32 Bio reports Q1 FY26 results, $65.5mln cash, Fast Track designation for bempikibart.

• Q32 Bio reports financial results for Q1 2025 • Cash and cash equivalents: $65.5 million • Expected to provide financial runway into 2H'26 • First patient dosed in SIGNAL-AA Phase 2a Part B • Topline data readout on-track for 1H'26 • First patient dosed in SIGNAL-AA Part A OLE • Fast Track designation granted for bempikibart in AA • SIGNAL-AA Part A results presented at AAD Annual Meeting

WALTHAM, Mass., May 8, 2025 — Q32 Bio Inc. (Nasdaq: QTTB) today reported its financial results for the first quarter of 2025, highlighting significant progress in its clinical trials and financial stability. The company reported cash and cash equivalents of $65.5 million as of March 31, 2025, which is expected to provide financial runway into the second half of 2026 [3].

Key highlights from the report include the dosing of the first patient in SIGNAL-AA Phase 2a Part B and the initiation of the Part A open-label extension (OLE). Additionally, the company received Fast Track designation (FTD) for its experimental treatment for alopecia areata, bempikibart (ADX-914) [3].

The SIGNAL-AA Phase 2a Part B trial, which is an open-label clinical trial evaluating bempikibart, is designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling pathways. The trial will dose approximately 20 evaluable patients with severe or very severe alopecia areata (AA) with bempikibart for 36 weeks, with follow-up out to 52 weeks. Topline data from this trial is expected to be read out in the first half of 2026 [3].

The company also initiated the Part A OLE of the SIGNAL-AA Phase 2a trial, which will enable longer-term follow-up of patients who completed Part A. Patient enrollment and dosing are ongoing [3].

The Fast Track designation granted by the FDA recognizes the seriousness of AA and the significant current unmet medical need while underscoring bempikibart's potential as a novel, differentiated therapy. The FDA designation allows for more frequent meetings with the agency, eligibility for priority review, and the possibility of accelerated approval, subject to clinical results [1].

Q32 Bio expects to report topline results from the SIGNAL-AA Phase 2a Part B trial in the first half of 2026. The company's recent progress in its clinical trials and financial stability position it well for continued development and potential regulatory approval of bempikibart.

References:
[1] https://stocktwits.com/news-articles/markets/equity/q32-bio-fda-fast-track-alopecia-retail-interest/chLHCHSRbin
[2] https://www.investing.com/analysis/palantir-earnings-1-bullish-signal-and-1-area-of-concern-200660277
[3] https://www.prnewswire.com/news-releases/q32-bio-reports-first-quarter-2025-financial-results-and-provides-corporate-update-302449312.html