Every 8-K that Q32 Bio Inc. (QTTB) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow QTTB and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full QTTB filings page.
Q32 Bio Inc. (symbol: QTTB) is the issuer of record for a Form 8-K filing submitted to the SEC. Q32 Bio Inc. reported additional results from Part B of its SIGNAL-AA Phase 2a trial of bempikibart in severe or very severe alopecia areata. In the 33-patient study, the company described clinically meaningful efficacy on primary and key secondary endpoints at Week 36, with responses maintained and deepened during the 16-week off-drug follow-up.
Q32 Bio described the safety profile as generally well tolerated, with no new safety signals and no serious or Grade 3-or-higher adverse events related to treatment. Injection-site reactions were the most common treatment-emergent adverse event (36.3%); their incidence was 4% across Part B dose administrations. The company plans to advance bempikibart into a registration-directed program in the first half of 2027, subject to planned regulatory discussions in the second half of 2026, and anticipates Part B open-label extension data in the second half of 2027.
Q32 Bio Inc. (QTTB) reported senior leadership changes, appointing José Trevejo, M.D., Ph.D. as Chief Medical Officer and Ellie Hershberger, Pharm.D. as Chief Development Officer. Both bring extensive late-stage clinical and regulatory experience in dermatology, rare diseases, infectious disease and biologics development.
The company describes itself as a clinical-stage biotechnology business developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases, led by its anti-IL-7Rα antibody bempikibart (ADX-914), now in a Phase 2 alopecia areata program. Q32 Bio states plans to advance bempikibart into a registration-directed program for severe or very severe alopecia areata in the first half of 2027 and to explore additional alopecia areata populations and other autoimmune indications, while emphasizing that these are forward-looking statements subject to clinical, regulatory and financing risks.
Q32 Bio Inc. reported second-quarter 2026 results and progress in its alopecia areata program. In Part B of the Phase 2a SIGNAL-AA trial, bempikibart achieved a 35.3% mean reduction in Severity of Alopecia Tool score in the modified intent-to-treat set; 40.0% of patients reached a SALT-20 response at Week 36 in that set and 30.3% in the full intent-to-treat population, with a generally well-tolerated safety profile. Enrollment and dosing continue in the open-label extension, and a registration-directed program in severe and very severe alopecia areata is planned for the first half of 2027, subject to regulatory discussions in late 2026.
Cash and cash equivalents were $106.3 million as of June 30, 2026, and a July 2026 public offering raised approximately $200.0 million in gross proceeds, which together are expected to fund operations through topline Phase 3 results for the planned registration-directed program. For the quarter, research and development expenses were $4.3 million, general and administrative expenses $4.9 million, and net loss $8.9 million, or $0.44 per share.
Q32 Bio Inc. entered an underwriting agreement for a public offering of equity securities. The company is issuing 6,027,399 shares of common stock at $18.25 per share and pre-funded warrants to purchase up to 4,931,506 shares of common stock at $18.2499 per warrant, with a $0.0001 exercise price per share. Underwriters also have a 30-day option to buy up to 1,643,835 additional shares.
The company expects net proceeds of about $187.6 million, or $215.8 million if the underwriters fully exercise the option, and plans to use them for working capital, including research, clinical development, and commercialization efforts such as advancing bempikibart into future clinical trials. Pre-funded warrants are immediately exercisable, subject to an Ownership Limit of 4.99% or 9.99%, adjustable up to 19.99% with 61 days’ notice, and will not be listed on an exchange.
Q32 Bio Inc. reported 36-week topline results from Part B of its SIGNAL-AA Phase 2a trial of bempikibart (ADX-914) in severe and very severe alopecia areata. In the modified intent-to-treat population of 25 patients, the mean Severity of Alopecia Tool (SALT) score was reduced by 35.3%, with a 37.8% reduction in severe patients and 27.4% in very severe patients.
Clinically meaningful responses were observed, with 40.0% of the mITT population and 30.3% of the full ITT population (33 patients) achieving SALT-20 at Week 36. Example cases showed patients reaching SALT-10 or SALT-0 and maintaining or deepening responses during 12–16 weeks off drug and into an open-label extension.
The company stated that bempikibart demonstrated a generally well-tolerated safety profile, with no Grade 3 or higher adverse events and low, mild injection site reaction rates among 33 treated patients. Pharmacokinetic data indicated steady state concentrations were achieved about 10 weeks earlier than in Part A, with negligible anti-drug antibodies. Q32 Bio plans to use the SIGNAL-AA data to engage the FDA on a registration-directed program targeting initiation in the first half of 2027.
Q32 Bio Inc. reported 36-week topline results from Part B of its SIGNAL-AA Phase 2a trial of bempikibart in severe and very severe alopecia areata. In 33 treated patients, the prespecified modified intent-to-treat analysis showed a 35.3% mean reduction in SALT score from baseline, with 40.0% of patients achieving a SALT-20 response at Week 36 in the mITT set and 30.3% in the ITT set of all enrolled patients.
Bempikibart was observed to have a generally well-tolerated safety profile, with no treatment-related serious adverse events or Grade 3 or higher events and mild injection site reactions in 36.3% of patients, corresponding to a 4% incidence across all dose administrations. Pharmacokinetic, pharmacodynamic and anti-drug antibody data were favorable, with the loading regimen achieving steady-state about 10 weeks earlier than in Part A and negligible ADA formation.
The Part A open-label extension in eight patients also supported longer-term tolerability and suggested durable or further hair growth for those maintaining hair at entry, reinforcing the importance of maintenance dosing. The company plans to advance bempikibart into a registration-directed program in the first half of 2027 and recently repaid the remaining approximately $6.8 million outstanding under its loan agreement with Silicon Valley Bank, which has now been terminated.
Q32 Bio Inc. reported the results of its 2026 Annual Meeting of Stockholders. Stockholders representing 11,833,800 common shares out of 15,629,463 entitled shares, or 75.71% of outstanding shares as of April 15, 2026, were present in person or by proxy.
All three Class II director nominees – Kathleen LaPorte, Jodie Morrison, and Arthur Tzianabos, Ph.D. – were elected to three-year terms ending at the 2029 annual meeting. Stockholders also ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
In addition, stockholders approved, on a non-binding, advisory basis, the compensation of the company’s named executive officers. The report was signed on behalf of the company by Chief Executive Officer Jodie Morrison.
Q32 Bio Inc. entered a securities purchase agreement with institutional and accredited investors for a private placement of 6,725,000 common shares and pre-funded warrants to purchase 150,000 shares. The shares are priced at $8.00 each and the warrants at $7.9999 with a nominal $0.0001 exercise price.
The pre-funded warrants are immediately exercisable and subject to a 9.99% beneficial ownership cap, adjustable up to 19.99% with 61 days’ notice. Q32 Bio expects aggregate gross proceeds of approximately $55 million, to be used with existing cash to advance clinical trials for bempikibart and for working capital and general corporate purposes. Closing is expected on May 28, 2026, and the company has agreed to file a resale registration statement for the shares and warrant shares.
Q32 Bio Inc. reported a smaller net loss for the quarter ended March 31, 2026 while advancing its lead alopecia areata program. Net loss was $7.6 million, or $0.54 per share, compared with $11.0 million, or $0.90 per share, a year earlier, driven by lower research and development and general and administrative expenses.
Cash and cash equivalents were $50.8 million as of March 31, 2026. Together with a completed $10.5 million registered direct offering, $14.2 million from the ATM program and guaranteed near-term milestone payments, the company expects its financial runway to extend into the first half of 2028. Q32 Bio expects 36-week topline data from the Part B Phase 2a SIGNAL-AA trial of bempikibart in mid-2026 and has begun dosing patients in an open-label extension.
Q32 Bio Inc. entered a new phase of its at-the-market stock offering program by filing an additional prospectus supplement that covers up to $75,000,000 of common stock to be sold through Cantor Fitzgerald & Co. under an existing Controlled Equity Sales Agreement.
The company previously sold $14,200,000 of common stock under an earlier prospectus supplement, which is now fully used and terminated. Future sales of the additional shares, if any, will be made under Q32 Bio’s effective Form S-3 shelf registration statement.
Q32 Bio Inc. entered into a Controlled Equity Sales Agreement with Cantor Fitzgerald & Co. to establish an at-the-market stock offering program. Under this agreement, Q32 Bio may sell shares of its common stock from time to time, with an aggregate offering price of up to $14,200,000.
The shares will be issued under an effective Form S-3 shelf registration and a related prospectus supplement. Q32 Bio will control key sale parameters and is not obligated to sell any shares. Cantor Fitzgerald will act as sales agent on a commercially reasonable efforts basis and receive a 3.0% cash commission on gross proceeds.
Q32 Bio Inc. reported a sharp turnaround to profitability for the quarter and year ended December 31, 2025, driven by collaboration revenue and an asset sale. Quarterly collaboration arrangement revenue was $53.7 million, supporting net income of $57.7 million, or $4.60 basic earnings per share, versus a net loss in the prior-year quarter.
For full-year 2025, Q32 Bio generated net income of $29.8 million, or $2.42 basic earnings per share, compared with a $47.7 million net loss in 2024. The swing was primarily due to non-cash collaboration revenue recognized under the amended Amgen agreement and the gain on sale of ADX‑097 to Akebia Therapeutics.
Cash and cash equivalents were $48.3 million as of December 31, 2025. Combined with gross proceeds from a $10.5 million registered direct offering completed in February 2026 and guaranteed near-term milestone payments from the ADX‑097 sale, the company expects funding to last into the fourth quarter of 2027.
Operationally, Q32 Bio completed enrollment in Part B of its SIGNAL‑AA Phase 2a trial of bempikibart in severe alopecia areata, expanding to 33 patients, with a 36‑week topline data readout anticipated in mid‑2026. An open-label extension from Part A remains ongoing to assess longer-term outcomes.
Q32 Bio Inc. entered into a definitive agreement for a registered direct offering raising approximately $10.5 million in gross proceeds. The company will sell 1,666,679 shares of common stock at $3.90 per share and issue pre-funded warrants to purchase up to 1,025,654 shares at $3.8999 per warrant, with a nominal exercise price of $0.0001 per share. The pre-funded warrants are immediately exercisable but subject to a 9.99% beneficial ownership cap. Q32 Bio plans to use the net proceeds, along with existing cash and securities, for working capital, including research, clinical development and commercialization efforts, and to advance its alopecia areata candidate bempikibart into future clinical trials.
Q32 Bio Inc. reported that it announced its financial results for the quarter ended September 30, 2025 and provided a corporate update. The company furnished a press release as Exhibit 99.1 to an Item 2.02 current report.
The information in the report, including Exhibit 99.1, is being furnished and is not deemed filed for purposes of Section 18 of the Exchange Act, nor incorporated by reference unless specifically stated. Q32 Bio’s common stock trades on the Nasdaq Global Market under the symbol QTTB.
Q32 Bio Inc. (QTTB) announced it has completed enrollment in Part B of its SIGNAL-AA Phase 2a clinical trial evaluating bempikibart for alopecia areata. The company disclosed the update via a press release titled “Q32 Bio Announces Completion of Enrollment in Part B of SIGNAL-AA Phase 2a Clinical Trial of Bempikibart for Alopecia Areata,” furnished as Exhibit 99.1.
Q32 Bio (NASDAQ:QTTB) announced the resignation of Chief Medical Officer Jason Campagna, M.D., Ph.D., effective July 9, 2025. The company has appointed Adrien Sipos, M.D., Ph.D. as Interim Chief Medical Officer, effective the same date. This Form 8-K filing discloses the leadership transition in the company's medical division.