Core Insights - Q32 Bio Inc. is a clinical-stage biotech company focused on developing Bempikibart, a treatment candidate for alopecia areata (AA) [1] - Bempikibart is currently in Phase 2a of the SIGNAL-AA trial and has shown positive data from previous studies [1] Company Overview - Q32 Bio Inc. specializes in biotechnology with a focus on innovative treatments for dermatological conditions [1] - The company is advancing its lead candidate, Bempikibart, through clinical trials to address unmet medical needs in alopecia areata [1]

1 Building The Future of Immune Therapeutics Company Overview March 2026 Forward Looking Statements This presentation has been prepared byQ32 Bio Inc. ("we", "us," "our," "Q32" or the "Company") and is made for informational purposes only. The information set forth herein does not purport to be complete or contain all of the information you may desire. Statements contained herein are made as of the date of this presentation unless stated otherwise, and this presentation shall not under any circumstances cre ...

Core Viewpoint - Q32 Bio reported a significant turnaround in financial performance for Q4 2025, achieving a net income of $57.7 million, driven by collaboration revenue and the sale of ADX-097, while focusing on advancing bempikibart for alopecia areata [1][2]. Financial Results - Net income for Q4 2025 was $57.7 million, translating to $4.60 per basic share and $4.58 per diluted share, compared to a net loss of $14.2 million in Q4 2024 [2][3]. - For the full year 2025, net income was $29.8 million, or $2.42 per share, compared to a net loss of $47.7 million in 2024 [2][3]. - General and administrative expenses were $4.5 million for Q4 2025, up from $4.0 million in Q4 2024, while full-year expenses decreased to $17.7 million from $18.0 million [2]. - Research and development expenses significantly decreased to $3.3 million for Q4 2025 from $10.5 million in Q4 2024, and for the full year, they dropped to $19.2 million from $48.1 million [2]. Corporate Updates - Q32 Bio completed a $10.5 million registered direct offering in February 2026, issuing 1,666,679 shares at $3.90 each [1][2]. - The company sold the Phase 2 complement inhibitor ADX-097 to Akebia Therapeutics for $12 million upfront, with potential total payments of up to $592 million based on future milestones [1][2]. - Enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial was completed, increasing the trial size to 33 patients, with topline data expected in mid-2026 [1][2]. Clinical Development - Bempikibart, a fully human anti-IL-7R antibody, is being evaluated in the SIGNAL-AA Phase 2a clinical trial for alopecia areata, with promising pharmacokinetic data suggesting earlier responsiveness [1][2]. - The trial aims to assess efficacy based on changes in Severity of Alopecia Tool (SALT) scores, with follow-up extending to 52 weeks [1][2].

Summary of Q32 Bio FY Conference Call Company Overview - **Company**: Q32 Bio (NasdaqGM:QTTB) - **Focus**: Development of bempikibart, a fully human antibody targeting alopecia areata and other diseases Key Points and Arguments Product Development - **Lead Asset**: Bempikibart is the primary focus, currently in development for alopecia areata, with proof of concept already established [2][3] - **Mechanism of Action**: Bempikibart binds to the IL-7 alpha receptor, blocking Th2 and Th1 cytokine signaling, which may provide broad therapeutic benefits across various diseases [2] - **Market Potential**: The alopecia areata market is expected to reach $2.6 billion by 2030, with a significant unmet need for biologics in this space [3] Clinical Trials - **SIGNAL-AA Study**: - Part A completed with positive results, leading to an open-label extension due to high patient demand [4] - Part B has enrolled 33 patients, with top-line data expected by mid-year 2026 [4][17] - The study design includes a 36-week dosing period and a focus on patient safety and response durability [9][10] Efficacy and Safety - **Part A Results**: Showed a statistically significant drop in SALT percentage, indicating meaningful hair growth responses [5][6] - **Durability of Response**: Continued hair growth observed even after treatment cessation, suggesting potential advantages over JAK inhibitors [6][7] - **Safety Profile**: Bempikibart's safety profile is favorable compared to JAKs, positioning it as a safer alternative for chronic use [8][12] Market Dynamics - **Current Treatment Landscape**: JAK inhibitors are the only approved treatments for alopecia areata, but their market penetration remains limited [25][26] - **Commercial Opportunity**: Bempikibart is expected to penetrate the market significantly and expand it, similar to trends seen with biologics in other conditions [25][26] Future Directions - **Phase III Plans**: Efficacy signals from Part B will inform the design of Phase III studies, with a target for SALT 20 responses in the mid-20s percentage range [61][62] - **Potential Indications**: While alopecia areata remains the primary focus, there are opportunities for bempikibart in other inflammatory diseases such as ulcerative colitis and celiac disease [61][62] Financials and Strategic Moves - **Partnership with Akebia**: Q32 Bio sold ADX-097 to Akebia for $12 million upfront, with potential total milestones of up to $592 million, allowing the company to focus on bempikibart [65][66] Conclusion - **Upcoming Milestones**: Anticipation for mid-year 2026 top-line results from the SIGNAL-AA study, which are expected to be significant for the company's future [68] This summary encapsulates the key points discussed during the conference call, highlighting Q32 Bio's strategic focus on bempikibart, its clinical development progress, market potential, and future directions.

Core Insights - Q32 Bio has completed enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial, increasing the trial size to 33 patients due to high patient demand, with topline data expected in mid-2026 [1][5][2] - The company reported cash and cash equivalents of $49.0 million as of September 30, 2025, which is anticipated to fund operations into 2027 [1][4][11] - The third quarter of 2025 showed a significant reduction in research and development expenses, totaling $3.6 million compared to $14.3 million in the same quarter of 2024 [4][6][11] Clinical Development - The SIGNAL-AA Phase 2a clinical trial is evaluating bempikibart, a fully human anti-IL-7R antibody, in patients with severe alopecia areata (AA) [5][7] - The trial includes a loading regimen of 200mg bempikibart weekly for four doses, followed by a maintenance dose every other week for a total of 36 weeks [5] - Preliminary pharmacokinetic data indicates that steady state drug concentration is achieved at least nine weeks earlier in Part B compared to Part A, suggesting potential for earlier clinical responsiveness [5][2] Financial Performance - Q32 Bio reported a net loss of $7.4 million for the quarter ended September 30, 2025, a decrease from a net loss of $17.6 million in the same quarter of 2024 [11][13] - General and administrative expenses decreased to $4.0 million from $4.5 million year-over-year, primarily due to lower personnel-related costs [11][4] - Total operating expenses for the third quarter of 2025 were $7.6 million, down from $18.8 million in the same period of 2024 [11][4] Market Context - Approximately 700,000 individuals in the United States are affected by alopecia areata, highlighting a significant market need for effective treatments [7] - Q32 Bio aims to provide a differentiated therapeutic option for AA patients, addressing the demand for safer and more durable treatment alternatives [2][5]

Core Insights - AbbVie announced positive topline results from the Phase 3 UP-AA clinical program for upadacitinib (RINVOQ) in treating severe alopecia areata, showing significant hair regrowth in patients [1][4][34] Study Results - In Study 1, 45.2% of patients on 15 mg and 55.0% on 30 mg of upadacitinib achieved 80% or more scalp hair coverage at week 24, compared to only 1.5% in the placebo group (p<0.001) [1][4] - Additionally, 35.2% and 45.8% of patients on 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage at week 24, compared to 0.7% in the placebo group (p<0.001) [2][4] - Key secondary endpoints were also met, including improvements in eyebrows and eyelashes, and complete scalp hair coverage (SALT=0) [2][4] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with treatment-emergent serious adverse events occurring in 1.9% and 1.8% of patients in the 15 mg and 30 mg groups, respectively, compared to 0.7% in the placebo group [2][4] - Common treatment-emergent adverse events included upper respiratory tract infections, acne, and increased blood creatine phosphokinase levels [2][4] Clinical Trial Design - The UP-AA clinical trial included two pivotal studies (Study 1 and Study 2) with a total of 1,399 participants aged 12 to 64 across 248 sites globally [5][34] - The studies were randomized, placebo-controlled, and double-blind, evaluating the efficacy and safety of upadacitinib over a total duration of 52 weeks [5][34]

Core Insights - AbbVie announced positive topline results from the Phase 3 UP-AA clinical program for upadacitinib (RINVOQ®) in treating severe alopecia areata, showing significant efficacy in hair regrowth [1][3][4] Efficacy Results - In Study 2, 44.6% of patients on 15 mg and 54.3% on 30 mg of upadacitinib achieved 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 3.4% in the placebo group (p<0.001) [1][3] - Additionally, 36.0% and 47.1% of patients reached 90% or more scalp hair coverage (SALT ≤ 10) with the respective doses, against 1.4% in the placebo group (p<0.001) [1][3] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with serious adverse events occurring in 1.4% and 2.8% of patients in the 15 mg and 30 mg groups, respectively, and none in the placebo group [1][3] - Common treatment-emergent adverse events included acne, nasopharyngitis, and upper respiratory tract infections, with serious infections reported infrequently [1][3] Study Design - The UP-AA clinical program consists of two pivotal studies (Study 1 and Study 2) with a total of 1,399 participants aged 12 to 64 across 248 sites globally [4][3] - Participants were randomized to receive either upadacitinib or placebo for 24 weeks, followed by an additional 28 weeks for those originally on upadacitinib [4] Future Outlook - Results from the parallel Study 1 are expected in the third quarter of 2025, which will further inform the efficacy and safety of upadacitinib in alopecia areata [3][4]

Core Insights - Q32 Bio Inc. has initiated dosing for the first patients in both Part A open-label extension and Part B of the SIGNAL-AA Phase 2a clinical trial for bempikibart, targeting alopecia areata [1][2] - The company reports encouraging clinical activity from Part A, with significant improvements in SALT scores and sustained responses observed in patients up to 55 weeks post-treatment [2][3] - Part B of the trial will involve approximately 20 patients over 36 weeks, with topline data expected in the first half of 2026 [3] Company Overview - Q32 Bio is a clinical stage biotechnology company focused on innovative therapies for alopecia areata and other autoimmune diseases, with an estimated 700,000 individuals affected in the U.S. [4] - The company is advancing bempikibart, a fully human anti-IL-7Rα antibody, which aims to re-regulate adaptive immune function [4] Clinical Trial Details - Part A of the SIGNAL-AA trial was a randomized, double-blind, placebo-controlled study that demonstrated significant clinical activity in patients with severe alopecia areata [2][3] - Part B will evaluate the efficacy of bempikibart based on mean percentage change in SALT scores and the proportion of subjects achieving specific SALT improvements [3]