Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Technical Presentation (October 2026)
34 slides from Aclaris Therapeutics's technical presentation, Oct 27, 2026
Slide 1: ATI-052 Phase 1b Primary Analysis Results: Atopic Dermatitis and Asthma
EMPOWERING PATIENTS THROUGH THERAPEUTIC INNOVATION October 27, 2026 ATI-052 Phase 1b Primary Analysis Results Atopic Dermatitis and Asthma
Slide 2: Forward-looking statements
2 Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “int
Slide 3: ATI-052: Potential Best-in-Class Bispecific mAb
3 4x More potent than dupilumab + tezepelumab combined $19B+1 In annual sales across the mechanisms it targets ATI-052: Potential Best-in-Class Bispecific mAb Phase 1b POC Results Validate Preclinical Potency Differentiation OVERVIEW: PROOF-OF-CONCEPT RESULTS 400+ hours Up to 116x longer residence t
Slide 4: Two Validated Mechanisms: A More Complete Approach to Inflammatory Disease
4 OVERVIEW: MECHANISM OF ACTION Two Validated Mechanisms A More Complete Approach to Inflammatory Disease ATI-052 Pathways Simultaneous control of upstream disease initiation and downstream Type 2 effector pathways ATI-052 IgG1 anti-TSLP / anti-IL-4Rα bispecific antibody Molecular architecture • Biv
Slide 5: Individual Components of ATI-052 are Both Important Targets
Individual Components of ATI-052 are Both Important ATI-052 Targets The Two Most Broadly Validated Nodes In Type 2 Disease: TSLP and IL-4Rα Approval Status by Indication/Mechanism TSLP IL-4Rα IL-13 EoE ✓ ✓ ✕ Asthma ✓ ✓ ✕ COPD ✕ ✓ ✕ CRSwNP ✓ ✓ ✕ AD ✓ ✓ Validated 3/5 5/5 1/5 ✓ Approved ✕ Not approved
Slide 6: Lebrikizumab: Baseline Severity Impacts Response Rates
Lebrikizumab: Absolute EASI Response (%) at Week 16 0 20 40 60 80 63.5 46.1 EASI ≤7 56.5 40.0 EASI ≤5 41.7 30.8 EASI ≤3 24.2 16.6 EASI ≤1 Moderate (IGA3) Severe (IGA4) Baseline Severity Impacts Response Rates PHASE 1b POC TRIAL I SIGNIFICANCE OF BASELINE SEVERITY IN AD % of patients Difficulty in Tr
Slide 7: Positive Phase 1b Primary Analysis Results: AD
ATI-052 Positive Phase 1b Primary Analysis Results: AD Strong POC in Severe AD (78% vIGA4); Efficacy Signals Support Advancement to Phase 2 CLINICAL RESULTS OVERVIEW: AD Favorable safety profile with no conjunctivitis observed ATI-052 has the potential to set a new efficacy ceiling in AD and other T
Slide 8: Positive Phase 1b Primary Analysis Results: Asthma
ATI-052 Positive Phase 1b Primary Analysis Results: Asthma Strong POC in Mild-to-Moderate Asthma; Rapid Response Supports Advancement to Phase 2 CLINICAL RESULTS OVERVIEW: ASTHMA Measure (D15) ATI-052 Single Dose (480mg) Placebo PBO-Adj. Change % Reduction in FeNO 59% 15% 44% 200 mL 0 mL 200 mL Incr
Slide 9: ATI-052 POC in Atopic Dermatitis (AD)
ATI-052 POC in Atopic Dermatitis (AD) Data cutoff date: August 20, 2026
Slide 10: Phase 1b POC Trial in Severe Atopic Dermatitis
10 Screening/ Washout Randomization 3:1 Active to Placebo Primary Endpoint Safety and tolerability Phase 1b POC Trial in Severe Atopic Dermatitis 14 AD Patients Placebo Q1wk (five doses) ATI-052 Q1wk (five doses, 480 mg) 12-week follow-up Day 57 (Week 8) Primary analysis Other Endpoints AD clinical
Slide 11: Baseline Demographics and Disease Severity
Baseline Demographics and Disease Severity 11 PHASE 1b POC TRIAL I ATI-052 IN AD: BASELINE CHARACTERISTICS Increased Percentage of African American and vIGA 4 Provides a More Severe / Difficult-to-Treat Patient Population1 SOURCE: 1. Sanyal RD, Guttman-Yassky E, et al. Ann Allergy Asthma Immunol. 20
Slide 12: ATI-052 Was Well Tolerated, With a Favorable Safety Profile
ATI-052 Was Well Tolerated, With a Favorable Safety Profile 12 Safety Summary ATI-052 N=11 (%) Placebo N=3 (%) Patients reporting ≥1 TEAE 6 (54.5) 2 (66.7) Patients reporting ≥1 serious TEAE 0 0 Patients reporting ≥1 Grade 3 or 4 TEAE 0 0 Patients who discontinued due to TEAE 0 0 Patients reporting
Slide 13: ATI-052 Demonstrated Robust EASI Improvement
-80% -60% -40% -20% 0% Baseline Week 4 Week 5 Week 6 Week 8 Week 10 ATI-052 Placebo ATI-052 Demonstrated Robust EASI Improvement Enrolled a Challenging Population to Treat: 78% Baseline vIGA4 Mean % Change in Baseline EASI Over Time Mean % Change in Baseline EASI Week 10 -62% -82% -56% -15% -90% -70
Slide 14: Early Efficacy Signal In Severe Disease Supports Phase 2b
Early Efficacy Signal In Severe Disease Supports Advancement to Phase 2b 45% 38% 33% 36% 0 10 20 30 40 50 ATI-052 Dupilumab Zumilokibart Lebrikizumab % Severe (vIGA 4) Subjects at Baseline 78% PHASE 1b POC TRIAL I ATI-052 IN AD: EASI 14 % Severe (vIGA 4) Subjects at Baseline 49% % Severe (vIGA 4) Su
Slide 15: ATI-052 Demonstrated Robust EASI-50 Response
15 ATI-052 Demonstrated Robust EASI-50 Response 100% 71% 42% ATI-052 (vIGA 3) ATI-052 (vIGA 4) Dupilumab SOURCE: Dupilumab: SOLO 1/2, 300 mg q2w pooled, approx. (Thaçi D, Simpson EL, et al. J Dermatol Sci. 2019;94(2):266–275). PHASE 1b POC TRIAL I ATI-052 IN AD: EASI Overall = 78% Pbo-adj. EASI-50 R
Slide 16: Rapid, Deep and Durable Reductions in Itch
-50 -40 -30 -20 -10 0 10 20 Baseline Week 1 Week 2 Week 4 Week 5 Week 6 Week 8 Week 10 Week 16 % change from baseline ATI-052 Placebo PHASE 1b POC TRIAL I ATI-052 IN AD: PP-NRS Rapid, Deep and Durable Reductions in Itch Observed Itch Relief Emerged Week One and Continued to Deepen Through Week 10 16
Slide 17: ATI-052 Showed Clinically Meaningful Improvements in Itch
PHASE 1b POC TRIAL I ATI-052 IN AD: PP-NRS 17 SOURCE: Dupilumab: PP-NRS4 - SOLO 1/2, 300 mg q2w pooled, approx. (Thaçi D, Simpson EL, et al. J Dermatol Sci. 2019;94(2):266–275.). Zumilokibart: APEX Part B mid dose (Apogee, APEX Part B 16-week data presentation, May 27, 2026). Lebrikizumab: ADvocate1
Slide 18: Photographic Examples of Clinical Activity
Photographic Examples of Clinical Activity 18 PHASE 1b POC TRIAL I ATI-052 IN AD: SKIN CLEARANCE Baseline Week 8 ATI-052 Load-in doses only Subject #1 vIGA 3 at Baseline Subject #2 vIGA 4 at Baseline
Slide 19: Potential Best-in-Class Pharmacodynamic Profile
Potential Best-in-Class Pharmacodynamic Profile TSLP + IL-4Rα | Evidence of Potential Additivity/Synergy Between Targets Broad Pathway Modulation Marked downregulation of inflammatory mediators pertinent to AD observed Pathways modulated Th1 Th2 Th17/Th22 Fibrosis Itch Normalization of Skin Proteome
Slide 20: ATI-052 Normalized Skin Proteome
PHASE 1b POC TRIAL I ATI-052 IN AD: PD AND TAPE STRIPS ATI-052 Normalized Skin Proteome ATI-052 Activity in Lesional Skin | Potential for Disease Modification KEY RESULTS 95% overall improvement in LS vs. NL proteome observed by Week 8 66% overall improvement in LS vs. NL skin with dupilumab by Week
Slide 21: Broad and Deep Biomarker Reductions
ATI-052 Demonstrated Broad and Deep Biomarker Reductions Median % Change from Baseline, Week 8 −76 −45 −43 −4 −16 -100 -75 -50 -25 0 25 50 75 CCL17 IL-5 Eosinophils (Week 12) NOTE: Sample sizes vary by endpoint and visit. GSVA: patients completing Week 8. ** p≤0.01, *** p≤0.001; + p<0.1. Navy asteri
Slide 22: ATI-052 POC in Asthma
ATI-052 POC in Asthma Data cutoff date: September 24, 2026
Slide 23: Phase 1b POC Trial in Asthma
23 Placebo (single dose) ATI-052 (single dose, 480 mg) Screening/ Washout Six-week follow-up Randomization 3:1 Active to Placebo Primary analysis through Day 29 Primary Endpoint Safety and tolerability Phase 1b POC Trial in Asthma 16 Patients Key Clinical Efficacy Assessment: FEV1, AX Other endpoint
Slide 24: Baseline Demographics and Asthma Severity
24 Characteristic ATI-052 (N=12) Placebo (N=4) Age, mean (SD), y 44.4 (12.6) 39.8 (17.6) Female, n (%) 3 (25.0) 3 (75.0) Weight, mean (SD), kg 86.0 (12.8) 75.8 (23.2) Duration of asthma from diagnosis, mean (SD), y 23.6 (12.0) 22 (20.8) FeNO, mean (SD), ppb 72.3 (33.3) 97.3 (62.5) Blood eosinophil c
Slide 25: Strong Tolerability Profile Observed with ATI-052
Strong Tolerability Profile Observed with ATI-052 Favorable Safety Profile 25 Safety Summary ATI-052 (N=12) Placebo (N=4) Patients reporting ≥1 TEAE, n (%) 6 (50) 1 (25) Patients reporting ≥1 serious TEAE, n (%) 0 0 Patients reporting ≥1 Grade 3 or 4 TEAE, n (%) 0 0 Patients who discontinued due to
Slide 26: Rapid FeNO Suppression Observed from Single Dose
Rapid FeNO Suppression Observed from Single Dose of ATI-052 Maximum FeNO Reduction of 59% and 45ppb Validate Potency of ATI-052 26 -59% -70% -60% -50% -40% -30% -20% -10% 0% Day 0 Day 8 Day 15 Day 29 % change from baseline ATI-052 Placebo -50 -45 -40 -30 -20 -10 0 Day 0 Day 8 Day 15 Day 29 Absolute
Slide 27: Single Dose Demonstrated Deep Reduction in FeNO
-59% -31% -36% -80% -70% -60% -50% -40% -30% -20% -10% 0% ATI-052 (Day 15) Anti-TSLP / IL-4Rα Dupilumab (Week 2) Anti-IL-4Rα Tezepelumab (Week 4) Anti-TSLP Single Dose of ATI-052 Demonstrated Deep Reduction in FeNO PHASE 1b POC TRIAL I ATI-052 IN ASTHMA: FeNO Maximum Mean FeNO % Reduction, Through W
Slide 28: Similar Results in T2-Low and T2-High Sub-Populations
Similar Results Observed in Both T2-Low and T2-High Sub-Populations PHASE 1b POC TRIAL I ATI-052 IN ASTHMA: FeNO & FEV1 28 NOTE: All subgroup analyses were conducted post hoc. T2-Low = <300 Eosinophils at baseline; T2-High = ≥300 eosinophils at baseline; PPB = parts per billion. 58% of ATI-052 Subje
Slide 29: FEV1 Improvement Aligned with FeNO Suppression
-200 mL -100 mL +0 mL +100 mL +200 mL Baseline Day 8 Day 15 Day 29 Mean pre-BD FEV1 change from baseline (mL) ATI-052 Placebo FEV1 Improvement Over Time FEV1 Improvement at Day 15 in Subjects with FEV1 <80% at Baseline +350 mL -140 mL -200 mL -100 mL +0 mL +100 mL +200 mL +300 mL +400 mL ATI-052 (FE
Slide 30: ATI-052 Improved FEV1 at Day 15
PHASE 1b POC TRIAL I ATI-052 IN ASTHMA: FEV1 SOURCE: Tezepelumab: approx. (Menzies-Gow et al., N Engl J Med. 2021;384:1800-1809). Dupilumab: approx.(Castro et al. N Engl J Med. 2018;378:2486-2496). NOTE: All subgroup analyses were conducted post hoc. FEV1 <80% at BL = pre-BD FEV1 value of < 80% at b
Slide 31: Rapid Small Airway Disease Improvement (AX)
-28 -2 -35 -30 -25 -20 -15 -10 -5 0 ATI-052 (480mg) Dupilumab (600mg Loading; Week 4) Placebo-adjusted change from baseline in pre-BD AX at Day 15 (cmH O·L 2 −1 ) 31 PHASE 1b POC TRIAL I ATI-052 IN ASTHMA: AX ATI-052 Demonstrated Rapid Small Airway Disease (SAD) Improvement AX (Area Under Reactance
Slide 32: ATI-052: Key Learnings and Next Steps
Key Learnings Additivity/synergy potential demonstrated across preclinical, clinical, and PD measures Breadth and depth of response: • Clinical and PD evidence of activity against all 3 inflammatory endotypes in severe AD • Both FENO & FEV1 improvements in T2 high & T2 low asthma patients Strong evi
Slide 33: Continued Clinical Momentum Through 2027
Continued Clinical Momentum Through 2027 Bosakitug (ATI-045) Anti-TSLP monoclonal antibody Phase 2 top line results in AD: 4Q 2026 ATI-052 Anti-TSLP / Anti-IL4Rα bispecific antibody Phase 2b program: Eosinophilic Esophagitis Atopic Dermatitis Asthma Modzatinib (ATI-2138) ITK/JAK3 Inhibitor Lichen pl
Slide 34: ATI-052 Phase 1b Primary Analysis Results: Atopic Dermatitis and Asthma
EMPOWERING PATIENTS THROUGH THERAPEUTIC INNOVATION October 27, 2026 ATI-052 Phase 1b Primary Analysis Results Atopic Dermatitis and Asthma
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