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Nature of the Business
3 Months Ended
Mar. 31, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of the Business

1. Nature of the Business

Organization

Q32 Bio Inc. (“Q32” or the “Company”) is a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (“AA”) and other autoimmune and inflammatory diseases. The Company is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function, for the treatment of AA in an ongoing Phase 2 program.

Registered Direct Offering

On February 17, 2026, the Company entered into a definitive agreement for the issuance and sale of 1,666,679 shares of common stock and pre-funded warrants to purchase up to 1,025,654 shares of common stock at an offering price of $3.90 per share of common stock, which was the closing price per share of the Company’s common stock on Nasdaq on February 13, 2026, and $3.8999 per pre-funded warrant, which represents the price per share for the common stock less the $0.0001 per share exercise price for each pre-funded warrant. The issuance of the shares was completed on February 19, 2026. The Company received net proceeds of $10.4 million pursuant to the registered direct offering (see Note 3 for more details surrounding the accounting for the pre-funded warrants).

The securities referenced above were offered pursuant to a shelf registration statement on Form S-3 (333-286491) that was filed with the SEC on April 11, 2025, and was declared effective by the SEC on April 21, 2025.

Entry into ATM Offering Program

On March 27, 2026, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Sales Agent”), with respect to an at-the-market (“ATM”) offering program pursuant to which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share (the “Shares”), through the Sales Agent. The Shares to be offered and sold under the Sales Agreement, if any, will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-286491), which was filed with the Securities and Exchange Commission (“SEC”) on April 11, 2025 and declared effective by the SEC on April 21, 2025. The Company filed a prospectus supplement with the SEC on March 27, 2026, pursuant to which the Company may offer and sell Shares having an aggregate offering price of up to $14.2 million pursuant to the Sales Agreement. There were no shares of common stock sold pursuant to the ATM during the three months ended March 31, 2026. On March 31, 2026, there remained $14.2 million of common stock available for sale under the ATM. Subsequent to March 31, 2026, the Company sold 2,326,952 shares of common stock and received net proceeds of $13.8 million pursuant to the ATM, and the Company also filed an additional prospectus supplement with the SEC on April 24, 2026, pursuant to which the Company may offer and sell additional Shares having an aggregate offering price of up to $75 million pursuant to the Sales Agreement.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, obtaining regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including preclinical and clinical testing, and will need to obtain regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. Since its inception, the Company’s operations have been focused on organizing and staffing, business planning, raising capital, establishing the Company’s intellectual property portfolio and performing research and development of its product candidates, programs and platform. The Company has primarily funded its operations with proceeds from the sale of convertible preferred stock, convertible notes, venture

debt, the Company’s reverse merger (the “Merger”) with Homology Medicines, Inc. (“Homology”) and accompanying Pre-Closing Financing and its former collaboration arrangement with Horizon.

Liquidity and Going Concern

In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued.

As of March 31, 2026, the Company had an accumulated deficit of $212.6 million and cash and cash equivalents of $50.8 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operating expenditures and capital expenditure requirements necessary to advance its research efforts and clinical trials for at least one year from the date of issuance of these unaudited condensed consolidated financial statements.

The Company has incurred recurring operating losses since its inception. During the three months ended March 31, 2026, the Company incurred a net loss of $7.6 million. The Company expects its operating losses and negative operating cash flows to continue into the foreseeable future. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurance that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all.