Aclaris Therapeutics, Inc. · NASDAQ:ACRS

Aclaris Therapeutics — Technical Presentation (June 2021)

16 slides from Aclaris Therapeutics's technical presentation, Jun 8, 2021

  1. Slide 1: ATI-1777-AD-201 Preliminary Topline Data

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0589 06/21) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) ATI-1777-AD-201 (Investigational Compound) Preliminary Topline

  2. Slide 2: Forward-looking statements

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defin

  3. Slide 3: Atopic Dermatitis Opportunity

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Atopic dermatitis (AD) is a chronic, pruritic inflammatory skin condition • The U.S. prevalence of AD is reported to be 11.3–12.7% in children and

  4. Slide 4: Soft Design: Multiple Metabolic Sites to Limit Systemic Exposure

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Soft Design: Multiple Metabolic Sites to Limit Systemic Exposure 4 Topically applied formulation of ATI-1777 Slow transdermal absorption Skin Blood

  5. Slide 5: ATI-1777-AD-201: Trial Design

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) ATI-1777-AD-201: Trial Design Eligibility • Adults with AD Diagnosis • Moderate or Severe (IGA 3 or 4) w/ 6 mo. history • 3-20% total AD BSA excl.

  6. Slide 6: Subject Disposition

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Subject Disposition 6 Discontinued Reasons Completed (PP) Allocated Randomized Enrolled N=97 N=50 ATI-1777 N=23 N= 21 (91%) Vehicle N=25 N=18 (72%)

  7. Slide 7: Demographics & Baseline Characteristics (FAS)

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Demographics & Baseline Characteristics (FAS) 7 ATI-1777 N=23 Vehicle N=25 Age Mean (SD) 43.1 (13.99) 41.4 (14.31) Sex Male N(%) 7 (30.4) 5 (20.0)

  8. Slide 8: Primary Efficacy Endpoint: % Change in mEASI – LOCF (FAS)

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Primary Efficacy Endpoint: % Change in mEASI – LOCF (FAS) 8 A sensitivity analysis conducted adding baseline EASI for 012-0016 and 013-0005 and usi

  9. Slide 9: Secondary Efficacy Endpoint: mEASI at Day 28 (FAS)

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Secondary Efficacy Endpoint: mEASI 50 at Day 28 (FAS) 9 Data on file Percent mEASI50 Response (95% CI)

  10. Slide 10: Secondary Efficacy Endpoint: IGA score of 0 or 1 with ≥2 Point Improvement at Day 28

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Secondary Efficacy Endpoint: IGA score of 0 or 1 with ≥2 Point Improvement at Day 28 (FAS) 10 Data on file

  11. Slide 11: Secondary Efficacy Endpoint: Change in BSA (FAS)

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Secondary Efficacy Endpoint: Change in BSA (FAS) 11 Data on file Change in BSA – LOCF (95% CI)

  12. Slide 12: Secondary Efficacy Endpoint: Peak Pruritus-NRS (FAS)

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Secondary Efficacy Endpoint: Peak Pruritus-NRS (FAS) 12 Data on file Change in PP - NRS – LOCF (95% CI)

  13. Slide 13: Plasma Levels of ATI-1777 Following Topical Application

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Plasma Levels of ATI-1777 Following Topical Application 13 • All concentrations < ½ IC50 (IC50 = 36 ng/mL for JAK1/3) • >86% of samples tested foll

  14. Slide 14: Summary of AEs (FAS)

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) Summary of AEs (FAS) 14 ATI-1777 N=23 Subjects (%) events Vehicle N=25 Subjects (%) events Total N=48 Subjects (%) events Subjects with at least on

  15. Slide 15: Adverse Events: Subjects with at Least One Event (FAS)

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) • No Serious Adverse Events • No subjects in ATI-1777 group W/D due to AE • 3 subjects in vehicle group W/D for COVID-19, SARS-CoV-2, & Application

  16. Slide 16: Conclusions

    © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) © Copyright 2021 Aclaris Therapeutics, Inc. All rights reserved (PP--US-0602 06/21) • Positive Proof of Concept First in Human Study ✓Moderate to Severe Atopic Dermatitis • Traditionally the domain of systemic therapy ✓Rapid and co

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