Q32 Bio Inc. · NASDAQ:QTTB
Q32 Bio — American Academy of Dermatology Late Breaker Session 2025
16 slides from Q32 Bio's conference presentation, Mar 8, 2025
Slide 1: Initial Results From The SIGNAL-AA Study: Phase 2a Trial of Bempikibart in Alopecia Areata
Initial Results From The SIGNAL-AA Study: Randomized Placebo Controlled Phase 2a Trial of a Bempikibart, Novel IL-7/TSLP Bifunctional Receptor Antagonist in Patients with Severe or Very Severe Alopecia Areata Dr. Brett King M.D., Ph.D. American Academy of Dermatology Late Breaker Session March 8, 20
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation has been prepared by Q32 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 contai
Slide 3: Alopecia Areata Has Life-Altering Impact and Current Treatment Options Are Limited
Alopecia Areata Has Life-Altering Impact and Current Treatment Options Are Limited 700K people living with AA in the U.S. 1 Often manifesting before age 50 Up to 40% become chronic, including complete loss of Olumiant approved in 2022, Litfulo approved scalp and/or body hair in 2023, Leqselvi approv
Slide 4: Bempikibart: Bifunctional IL-7Rα Antagonist Antibody That Blocks IL-7 and TSLP Signaling
Bempikibart: Bifunctional IL-7Rα Antagonist Antibody That Blocks IL-7 and TSLP Signaling IL-7 receptor TSLP receptor Provides novel mechanism Central regulator of dendritic for rebalancing Teff/mem cell differentiation, and Treg function Th2 cytokine production Favorable PK and Receptor Occupancy ob
Slide 5: SIGNAL-AA First-in-Patient Observations of Durable Response Supported by Broad Literature
SIGNAL-AA First-in-Patient Observations of Durable Response Supported by Broad Literature Describing IL-7 Mechanistic Modulation of Teff/mem cells 5
Slide 6: Phase 2a Part A: POC Study in Patients with Alopecia Areata
SIGNAL-AA Phase 2a "Part A": POC Study in Patients with Alopecia Areata Study Design Part A Design Elements • First study in AA patients • Key Inclusion/Exclusion Criteria • Severe/Very Severe Alopecia Bempikibart (n=33) Areata (SALT 50-100) Randomization 200 mg Q2W • No other forms of Alopecia Effi
Slide 7: Part A: Demographics
SIGNAL-AA Part A: Demographics Characteristics Per Protocol Population (PP) Modified Intent To Treat Population (mITT) Bempikibart 200 mg Placebo Bempikibart 200 mg Placebo Total (N=27) Total (N=41) (N=23) (N=4) (N=33) (N=81) Age (years), Mean (SD) 47.7 (11.3) 59.8 (11.9) 49.5 (12.0) 48.8 (10.2) 46.
Slide 8: Part A SALT Data Through Week 36 Showed Continued Benefit Over Time
SIGNAL-AA: Part A SALT Data Through Week 36 Showed Continued Benefit Over Time Supporting Potential for Durable Effect Following Dosing Cessation SALT Percentage Change Over Time SALT Percentage Change Over Time (SIGNAL AA, PP 1 2 3) (SIGNAL AA, mITT 1 2 3) Placebo Placebo (N=4) Last Dose (N=8) 10 L
Slide 9: Bempikibart Demonstrated Improvement on SALT Reduction at Week 24, Continued Effects Through Week 36
Bempikibart Demonstrated Impressive Improvement on SALT Reduction at Week 24 Shows Continued Effects After Dosing Cessation through Week 36 Patients with baseline SALT 50-100, PP1 Week 24 Week 262 Week 363 Plasma PK > Threshold Plasma PK > Threshold Plasma PK < Threshold N=23 Dosing N=21 N=194 Mean
Slide 10: Case Study - Severe AA with 4.5 Year Episode: Response through Week 42
SIGNAL-AA Case Study - Severe AA with 4.5 Year Episode: Response through Week 42 Supports Potential for Durable Hair Regrowth with Bempikibart Treatment Baseline Week 24 Week 36 Week 42 52-year-old female Duration of episode: 4.5 years Baseline SALT: 56 (Severe) SALT (Week 24): 10.5 SALT (
Slide 11: Examples of Continued Response 7 Months Post Dosing Cessation
SIGNAL-AA Examples of Continued Response 7 Months Post Dosing Cessation: Supports Potential for Remittive Effect with Bempikibart Treatment Baseline Week 24 Week 36 Week 57 Case 1 61-year-old female Duration of Episode: 3.1 years 7 months post Baseline SALT: 98.2 (Very Severe) last dose with n
Slide 12: Potential for Durable Responses Supported by Longer-Term Follow-Up
Potential for Bempikibart to Induce Durable Responses Supported by Longer-Term Follow-Up • A patient contacted sponsor with post-study hair growth requesting expanded access • Sponsor contacted all site investigators regarding patient follow-up • Of patients who responded that completed the treatmen
Slide 13: Overall Summary of Treatment Emergent Adverse Events Through Week 36
SIGNAL AA: Overall Summary of Treatment Emergent Adverse Events Through Week 36 Bempikibart1 Placebo (N = 33) (N = 8) n (%) [# Events] n (%) [# Events] Participants with at least 1 TEAE 23 (70%) [108] 3 (38%) [9] Participants with at least 1 TEAE by greatest reported relationship with study treatmen
Slide 14: Phase 2a: Part A and Part B Study Designs
SIGNAL-AA Phase 2a: Part A and Part B Study Designs Part A Week 24 DesignPart Elements Primary Endpoint A Percent change from baseline in SALT score at Week 24 Week 36 Part B Randomization Bempikibart (n=33) • Key Inclusion/Exclusion Criteria Screening Open-Label Extension 3:1 200 mg Q2W (24-weeks)
Slide 15: Summary: Maturing SIGNAL-AA Data Supports Potentially Differentiated Profile in Alopecia Areata
Summary: Maturing SIGNAL-AA Data Supports Potentially Differentiated Profile in Alopecia Areata • Hair regrowth with durable response supports potential for transformative paradigm; extensive MOA literature supports potential long-term durability of effect post-dosing cessation • Response to bempiki
Slide 16: Thank you to all the clinical trial investigators and patients in the SIGNAL-AA trial
Thank you to all the clinical trial investigators and patients in the SIGNAL-AA trial Thank you to the American Academy of Dermatology for the opportunity to share these data today
Q32 Bio — American Academy of Dermatology Late Breaker Session 2025 on 6ix