Clinical Trials and Product Development - Bempikibart (ADX-914) has completed two Phase 2a clinical trials, with topline results announced in December 2024, and further data expected in mid-2026[165][170]. - In the SIGNAL-AA Part A trial, 44 patients were dosed, showing significant hair regrowth compared to placebo, with continued improvement observed during a 12-week follow-up[166]. - The FDA granted Fast Track designation to bempikibart for the treatment of alopecia areata in April 2025, facilitating expedited development and review[171]. - A corporate restructuring in February 2025 focused on advancing bempikibart, resulting in the discontinuation of the Phase 2 renal basket clinical trial of ADX-097[175]. - Legacy Q32 retained full development and commercial rights to bempikibart after terminating the collaboration agreement with Horizon Therapeutics[177]. Financial Performance and Expenses - As of September 30, 2025, the company had cash and cash equivalents of $49.0 million, expected to fund operations into 2027[183]. - The company does not expect to generate revenue from product sales in the foreseeable future, as it has not generated any revenue since inception[186]. - Research and development expenses for Q3 2025 were $3.6 million, a decrease of $10.8 million from $14.3 million in Q3 2024, primarily due to lower clinical costs[204]. - General and administrative expenses for Q3 2025 were $4.0 million, down from $4.5 million in Q3 2024, reflecting reduced personnel-related costs[206]. - Other income for Q3 2025 was $0.2 million, a decrease of $1.0 million from $1.2 million in Q3 2024, mainly due to lower interest income[207]. - Legacy Q32's total operating expenses for Q3 2025 were $7.6 million, down from $18.8 million in Q3 2024, resulting in a loss from operations of $7.6 million[203]. - The company reported a net loss of $27.9 million for the nine months ended September 30, 2025, compared to a net loss of $33.5 million in 2024, an improvement of $5.6 million[208]. - Net cash used in operating activities was $27.4 million for the nine months ended September 30, 2025, compared to $56.3 million in 2024, a reduction of $28.9 million[221]. - The company incurred significant operating losses with an accumulated deficit of $262.7 million as of September 30, 2025[216]. Capital Requirements and Funding - The company anticipates needing to raise additional capital to advance its programs through regulatory approval and potential commercialization[184]. - The company requires substantial additional capital to complete the development of product candidates and build necessary sales, marketing, and distribution infrastructure[230]. - Management expects to seek additional capital through private or public equity or debt financings, which may dilute existing stockholders' ownership[231]. - The company raised $136.0 million in aggregate cash proceeds from the sale of convertible preferred stock and convertible notes since inception[215]. Licensing Agreements and Obligations - The company has a license agreement with Bristol-Myers Squibb, involving an upfront payment of $8 million and potential milestone payments ranging from $32 million to $49 million per indication[237]. - Under the BMS License Agreement, tiered royalties on net sales range from mid-single digit percentages to up to 10% based on cumulative net sales[237]. - The company has a license agreement with the University of Colorado, with potential milestone payments of up to $2.2 million per licensed product and tiered royalty rates in the low single digits[244]. - Legacy Q32 is obligated to pay Horizon up to $75.1 million contingent on regulatory and sales-based milestones, including $5.0 million upon first regulatory approval[189]. Corporate Structure and Changes - The merger with Homology was completed on March 25, 2024, with Legacy Q32 stockholders owning approximately 74.4% of the combined company post-merger[179][180]. - The company incurred approximately $0.9 million in severance and severance-related charges as part of the restructuring plan[175]. - Following Amgen's acquisition of Horizon, the company retained all initial consideration and development funding, regaining full rights to bempikibart[241]. Accounting and Reporting - The company’s critical accounting policies have not materially changed during the three months ended September 30, 2025[247]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[249].

Third Quarter 2025 and Recent Business Highlights Q32 Bio Reports Third Quarter 2025 Financial Results and Provides Corporate Update -- Completed enrollment in Part B of SIGNAL-AA Phase 2a clinical trial and increased trial size to 33 patients based on patient demand; topline data readout expected in mid-2026 -- -- Dosing of patients in Part A open-label extension (OLE) ongoing -- -- Cash and cash equivalents of $49.0 million as of September 30, 2025 expected to provide financial runway into 2027 -- WALTHAM ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Q32 Bio Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-3468 ...

[Second Quarter 2025 and Recent Business Highlights](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Business%20Highlights) Q32 Bio advanced bempikibart development, with SIGNAL-AA trial Part B topline data expected 1H 2026, and received Fast Track designation - Dosing of patients in Part B of the SIGNAL-AA Phase 2a clinical trial is ongoing, with topline data readout on-track for the **first half of 2026**; Part B will evaluate bempikibart in approximately **20 evaluable patients** with severe or very severe AA for **36 weeks**[3](index=3&type=chunk)[4](index=4&type=chunk) - Dosing of patients in Part A OLE of the SIGNAL-AA Phase 2a clinical trial is ongoing, initiated due to continued emergence of bempikibart data suggesting a remittive effect and durable responses[6](index=6&type=chunk) - **Adrien Sipos, M.D., Ph.D.**, an immunologist and seasoned Immunology and Inflammation (I&I) drug developer, was appointed as **Interim Chief Medical Officer**[1](index=1&type=chunk)[6](index=6&type=chunk) - **Fast Track designation (FTD)** was granted to bempikibart for the treatment of AA, designed to facilitate development and expedite review of new drugs for serious diseases with unmet medical needs[6](index=6&type=chunk) [Financial Runway Update](index=1&type=section&id=Financial%20Runway%20Update) Q32 Bio reported **$54.8 million** in cash and cash equivalents as of June 30, 2025, extending its financial runway into 2027, covering key clinical milestones Cash and Cash Equivalents | Metric | Value (as of June 30, 2025) | | :----- | :-------------------------- | | Cash and cash equivalents | $54.8 million | - Q32 Bio believes its cash and cash equivalents are sufficient to fund operations **into 2027**, through the SIGNAL-AA OLE and topline results of the SIGNAL-AA Part B trial[6](index=6&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses significantly decreased in Q2 2025 versus Q2 2024, driven by lower bempikibart development, reduced ADX-097 expenses, and lower personnel and legal costs post-restructuring Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) (in thousands) | | :--------------- | :--------------------- | :--------------------- | :-------------------------- | | Research and development | $5,161 | $13,411 | -$8,250 | | General and administrative | $4,010 | $4,508 | -$498 | | Total operating expenses | $9,171 | $17,919 | -$8,748 | - The decrease in R&D expenses was primarily due to **lower bempikibart development costs** (clinical and manufacturing), **lower direct R&D expenses related to ADX-097**, and **lower personnel-related costs** due to the discontinuation of the ADX-097 Phase 2 clinical trial and restructuring announced in February 2025[6](index=6&type=chunk) - The decrease in G&A expenses was primarily due to **lower personnel-related costs** as a result of **reduced headcount** associated with the restructuring in February 2025, as well as **lower legal costs**[7](index=7&type=chunk) [Net Loss and EPS](index=3&type=section&id=Net%20Loss%20and%20EPS) Q32 Bio reported a net loss of **$9.5 million** or **$0.78 per share** for Q2 2025, a significant improvement from **$17.0 million** or **$1.42 per share** in Q2 2024 Net Loss and EPS (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net loss | $(9.5) million | $(17.0) million | $(7.5) million decrease | | Net loss per share (basic & diluted) | $(0.78) | $(1.42) | $(0.64) decrease | [About Q32 Bio](index=3&type=section&id=About%20Q32%20Bio) [Company Overview and Therapeutic Focus](index=3&type=section&id=Company%20Overview%20and%20Therapeutic%20Focus) Q32 Bio is a clinical-stage biotechnology company developing innovative therapies for autoimmune and inflammatory diseases, especially alopecia areata, with lead candidate bempikibart in a Phase 2 program - Q32 Bio is a **clinical stage biotechnology company** whose science targets **potent regulators of the adaptive immune system** to re-balance immunity, focused on developing innovative therapies for **alopecia areata** and other autoimmune and inflammatory diseases[8](index=8&type=chunk) - **Bempikibart (ADX-914)**, a fully human **anti-IL-7Rα antibody** that re-regulates adaptive immune function, is being advanced for the treatment of alopecia areata in an ongoing **Phase 2 program**[8](index=8&type=chunk) - Approximately **700,000 people** in the United States live with **alopecia areata**, a disease with a life-altering impact and limited current treatment options[8](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section outlines Q32 Bio's forward-looking statements regarding clinical trials, product efficacy, regulatory processes, financial runway, and business plans, all subject to inherent risks and uncertainties - This communication contains **forward-looking statements** regarding Q32 Bio's beliefs, observations, expectations, and assumptions concerning **clinical trials (SIGNAL-AA Part B timing and data)**, **bempikibart's safety, efficacy, and benefits**, **FTD benefits**, **leadership appointments**, and **financial runway into 2027**[10](index=10&type=chunk)[11](index=11&type=chunk) - Forward-looking statements are based on management's current beliefs and assumptions, but are subject to **risks and uncertainties**, including that additional data may not support current beliefs, clinical studies may not be completed as anticipated or yield expected results, FTD may not accelerate processes, and capital resources may be used sooner than expected[12](index=12&type=chunk) [Contacts](index=4&type=section&id=Contacts) [Investor and Media Relations](index=4&type=section&id=Investor%20and%20Media%20Relations) This section provides contact information for investor and media inquiries, directed to Argot Partners - Investor contact: **Brendan Burns**, **Argot Partners**, 212.600.1902, Q32Bio@argotpartners.com[13](index=13&type=chunk) - Media contact: **David Rosen**, **Argot Partners**, 646.461.6387, david.rosen@argotpartners.com[13](index=13&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The Condensed Consolidated Statements of Operations show a net loss of **$9.5 million** for Q2 2025, an improvement from **$17.0 million** in the prior year, due to reduced operating expenses Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $5,161 | $13,411 | $12,286 | $23,252 | | General and administrative | $4,010 | $4,508 | $9,114 | $9,510 | | Total operating expenses | $9,171 | $17,919 | $21,400 | $32,762 | | Loss from operations | $(9,171) | $(17,919) | $(21,400) | $(32,762) | | Net loss | $(9,489) | $(16,978) | $(20,520) | $(15,949) | | Net loss per share—basic | $(0.78) | $(1.42) | $(1.68) | $(2.46) | | Net loss per share—diluted | $(0.78) | $(1.42) | $(1.68) | $(4.44) | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The Condensed Consolidated Balance Sheets show cash and cash equivalents decreased to **$54.8 million** as of June 30, 2025, from **$78.0 million** at December 31, 2024, with total assets decreasing and stockholders' equity shifting to a deficit Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change (in thousands) | | :-------------------- | :------------ | :---------------- | :-------------------- | | Cash and cash equivalents | $54,832 | $77,965 | -$23,133 | | Total assets | $66,117 | $92,332 | -$26,215 | | Stockholders' equity (deficit) | $(12,235) | $5,675 | -$17,9

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Q32 Bio Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-346 ...

Exhibit 99.1 Q32 Bio Reports First Quarter 2025 Financial Results and Provides Corporate Update -- 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 open label extension (OLE) -- -- Fast Track designation (FTD) granted to bempikibart for the treatment of alopecia areata (AA); SIGNAL-AA Part A results presented as a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting -- -- Cash a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-38433 Q32 Bio Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-3468154 (S ...

Exhibit 99.1 • Presented results from SIGNAL-AA Phase 2a Part A clinical trial of bempikibart in alopecia areata (AA) as a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting. The late-breaking presentation highlighted additional results from Part A of the SIGNAL-AA Phase 2a clinical trial of bempikibart, a fully human anti- IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, beyond what was previously reported in ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Q32 Bio Inc. (Exact name of registrant as specified in its charter) ( State or othe ...

Exhibit 99.1 Q32 Bio Reports First Quarter 2024 Financial Results and Provides Corporate Update -- Completed enrollment in bempikibart alopecia areata (AA) Phase 2 clinical trial, with topline results expected in Q4'24; enrollment in bempikibart atopic dermatitis (AD) Phase 2 clinical trial remains on- track, with topline results expected in Q4'24 -- -- ADX-097 continues to advance, with anticipated Phase 2 clinical trial initiations on-track: renal basket in 1H'24 and ANCA-associated vasculitis (AAV) in 1H ...