Aclaris Therapeutics, Inc. · NASDAQ:ACRS

Aclaris Therapeutics — Technical Presentation (November 2023)

15 slides from Aclaris Therapeutics's technical presentation, Nov 13, 2023

  1. Slide 1: Zunsemetinib (ATI-450) Phase 2b Rheumatoid Arthritis Trial Top-line Results

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Zunsemetinib (ATI-450) Phase 2b Rheumatoid Arthritis Trial Top-line Results November 13, 2023 EMPOWERING PATIENTS THROUGH KINOME INNOVATION

  2. Slide 2: Cautionary Note Regarding Forward-Looking Statements

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Cautionary Note Regarding Forward-Looking Statements 2 Any statements contained in this presentation that do not describe historical facts may constitute forward-looki

  3. Slide 3: Trial Design

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Trial Design 3 Screening Period Up to 28 days Treatment Period 12 weeks Follow-up Period 30 days ATI 450 (20 mg BID) + MTX n=84 ATI 450 (50 mg BID) + MTX n=83 Placebo

  4. Slide 4: Patient Disposition: Treatment Arms Nearly Equal at Randomization with Higher Discontinuation in Active Arms

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Patient Disposition: Treatment Arms Were Nearly Equal At Randomization with Higher Discontinuation Rate in Active Arms 4 Screened: 428 Randomized: 251 Placebo 84 ATI-4

  5. Slide 5: Demographics: Arms Were Generally Balanced and Similar to Comparable Studies

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Demographics: Arms Were Generally Balanced and Similar to Comparable Studies 5 Parameter Placebo BID (N=84) ATI-450 20 mg BID (N=83) ATI-450 50 mg BID (N=84) Age (mean

  6. Slide 6: Baseline Disease Characteristics Were Generally Balanced Across Treatment Arms

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Baseline Disease Characteristics Were Generally Balanced Across Treatment Arms and Generally Similar to Comparable Studies 6 Parameter Placebo BID (N=84) ATI-450 20 mg

  7. Slide 7: High Discontinuation Rate at 50 mg Mainly Due to Adverse Events and Withdrawal of Consent

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) High Discontinuation Rate with ATI-450 at the 50 mg Dose was Mainly Due to Adverse Events and Withdrawal of Consent 7 Reason Placebo N = 84 ATI-450 20 mg N = 83 ATI-45

  8. Slide 8: Primary and Key Secondary Efficacy Endpoints at Week 12 Failed to Differentiate from Placebo

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Primary and Key Secondary Efficacy Endpoints at Week 12 Failed to Differentiate from Placebo -10 0 10 20 30 40 50 60 70 Placebo ATI-450 20mg ATI-450 50mg ACR 20 % at W

  9. Slide 9: Overall Summary of Adverse Events

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Overall Summary of Adverse Events (AE): More Treatment Emergent Adverse Events (TEAE) and Discontinuations Due to AEs with Increasing Dose Most TEAEs were Mild or Mode

  10. Slide 10: TEAEs Occurring in Patients in 50 mg Arm by Preferred Term

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) TEAEs Occurring in ≥ 2 Patients in 50 mg arm by Preferred Term Most common TEAEs on 50 mg are Nausea, Nasopharyngitis, CK increased, and Diarrhea 10 Preferred Term Pla

  11. Slide 11: ATI-450 Plasma Concentrations

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) ATI-450 Plasma Concentrations 11 Mean ATI-450 Plasma Concentration 50 mg BID (ng/mL) Co-Med Day 1 2h postdose Day 7/8 predose Day 7/8 2h postdose Day 84/85 predose Day

  12. Slide 12: Preliminary Exploratory Pharmacodynamic Analysis

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Preliminary Exploratory Pharmacodynamic Analysis 12 TNFa • Data calculated as percent Day 1 pre-dose by subject. Healthy donor levels expressed as percent of RA patien

  13. Slide 13: Summary of Results and Conclusions

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) • Efficacy: ATI-450 20 mg BID and 50 mg BID did not differentiate from placebo in ACR20 and other measures o Efficacy of ATI-450 20 mg BID, 50 mg BID and placebo were

  14. Slide 14: Phase 2b Trial of ATI-1777 in Atopic Dermatitis Results Expected Around Year End 2023

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Phase 2b Trial of ATI-1777 in Atopic Dermatitis Results Expected Around Year End 2023 14 Primary endpoint: % change from baseline to week 4 in EASI Secondaries include

  15. Slide 15: Drug Development Pipeline Fueled by the KINect Platform Discovery Engine

    © Copyright 2023 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Drug Development Pipeline Fueled by the KINect® Platform Discovery Engine 15 * This is an investigator-initiated Phase 1a trial in patients with advanced solid tumor m

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