Aclaris Therapeutics, Inc. · NASDAQ:ACRS

Aclaris Therapeutics — Investor Presentation (November 2024)

35 slides from Aclaris Therapeutics's investor presentation, Nov 18, 2024

  1. Slide 1: Corporate Overview November 2024

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved Confidential © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved Corporate Overview November 2024

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

    © Copyright 2024 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: Executive Summary

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) • In-licensing two biologics from Biosion • BSI-045B – anti-TSLP mAb (Phase 2) • BSI-502 – anti-TSLP/IL4R BsAb (IND enabling tox) • Broad Immunology-Focused Developmen

  4. Slide 4: Biotechnology Company Focused on Immuno-inflammatory Diseases

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Biotechnology Company Focused on Immuno-inflammatory Diseases with Large and Small Molecule Therapeutics Pipeline + Platform + People Innovative Pipeline (investigatio

  5. Slide 5: Experienced Leadership Team

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Experienced Leadership Team • 25+ years life sciences experience • Successful serial entrepreneur; founder and leader of several life science companies including Aclar

  6. Slide 6: Broad Immunology Development Pipeline

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Program Indication(s) Preclinical Phase 1 Phase 2 Phase 3 BSI-045B TSLP mAb Subcutaneous Atopic Dermatitis (moderate-to-severe) ATI-2138 ITK/JAK3 Inhibitor Oral Atopic

  7. Slide 7: BSI-045B: Anti-TSLP Monoclonal Antibody Program

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Confidential BSI-045B: Anti-TSLP Monoclonal Antibody Program (Investigational Drug Candidate) 7

  8. Slide 8: BSI-045B Overview

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) • BSI-045B is a humanized monoclonal antibody targeting thymic stromal lymphopoietin (TSLP) • TSLP - master regulator of type 2 (Th2) immune responses at the barrier s

  9. Slide 9: BSI-045B Key Properties: 60x More Potent than Tezepelumab

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) BSI-045B Key Properties 60x More Potent than Tezepelumab • Very high affinity to TSLP • Extremely low dissociation rate from TSLP*, leading to long residence time and

  10. Slide 10: Dissociation Kinetics of TSLP Binding to anti-TSLP mAb

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Dissociation Kinetics of TSLP Binding to anti-TSLP mAb using TR-FRET Dissociation of TSLP from mAbs Residence Time on TSLP (n=3) • BSI-045B and BSI-502 demonstrate ver

  11. Slide 11: BSI-045B Has Greater Potency Than Other TSLP/TSLPR Antibodies

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) BSI-045B Has Greater Potency Than Other TSLP/TSLPR Antibodies 11 TSLP Stimulated CCL17 Production from hPBMC (0.1ng/ml TSLP) • BSI-045B is the most potent of the TSLP/

  12. Slide 12: BSI-045B Phase 2a POC Monotherapy Study Summary

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Clinical Translation: BSI-045B Phase 2a (US-Based) POC Monotherapy Study Summary 12 Screening/ Washout 300 mg QW 12 Week Follow-up 300 mg Q2W Primary Objectives • To e

  13. Slide 13: BSI-045B Exposure and Efficacy Time Profile

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) • A time lag in efficacy response relative to exposure was observed both while the drug was onboard and after the last dose • EASI-75 sustained response after the last

  14. Slide 14: BSI-045B Improvement in Efficacy Measures (Week 26)

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) BSI-045B Demonstrated Improvement in Efficacy Measures (Week 26, N=17) 14 EASI 75 % @ Week 26 EASI 90 % @ Week 26 EASI 100 % @ Week 26 IGA 0/1 @ Week 26 94% 65% 24% 88

  15. Slide 15: BSI-045B Safety and Immunogenicity Profile

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Safety • A total of 13 (59.1%) participants had TEAEs, and 3 (13.6%) had treatment-related TEAEs o Among 13 participants with TEAEs, 2 participants had grade 2 TEAEs (

  16. Slide 16: Comparison to Dupilumab and Tezepelumab Studies

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Comparison to Dupilumab Mono, Combo, and Tezepelumab Combo Studies** Percent Change from Baseline EASI Score 16 Percent Change From Baseline EASI Score 1,2 1,2 2,3 2,3

  17. Slide 17: Unmet Medical Needs in Atopic Dermatitis Treatment

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Significant Unmet Medical Needs Exist For Current Atopic Dermatitis Treatment BSI-045B Has Best-in-class Potential Compared to Currently Approved Agents 17 Unmet Medic

  18. Slide 18: BSI-045B Summary

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) BSI-045B Summary • BSI-045B exhibits high affinity, slow dissociation and long residence time - results in very high potency • BSI-045B’s high potency and long half-li

  19. Slide 19: BSI-502: Anti-TSLP x IL4R Bispecific Antibody Program

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Confidential BSI-502: Anti-TSLP x IL4R Bispecific Antibody Program (Investigational Drug Candidate) 19

  20. Slide 20: BSI-502 Key Asset Highlights

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) BSI-502 – Key Asset Highlights • Exhibits high binding affinity to and dual blockade of both TSLP and IL4R • Anti-TSLP mAb component has Fc engineered to bind more tig

  21. Slide 21: BSI-502 Greater Cellular Bioactivity than Tezepelumab plus Dupilumab

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) BSI-502 Exhibits Greater Cellular Bioactivity than the Combination of Tezepelumab and Dupilumab on CCL17 Release 1 0 - 3 1 0 - 2 1 0 - 1 1 0 0 1 0 1 1 0 2 1 0 3 0 .0 0

  22. Slide 22: Bispecific Approach: Blocking Both IL4R and TSLP

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Bispecific Approach: Blocking both IL4R and TSLP Could Drive Enhanced Efficacy Tezepelumab and Dupilumab Efficacy in COPD Placebo (N=471) DUPI(N=468) Placebo (N=465) D

  23. Slide 23: BSI-045B and BSI-502 Summary

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) BSI-045B and BSI-502 Summary *Superior characteristics (potency, affinity, bioavailability, and bioactivity) in comparison to tezepelumab based on internal data **Data

  24. Slide 24: ATI-2138: A First-Generation Novel ITK/JAK3 Inhibitor

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Confidential ATI-2138: A First-Generation Novel ITK/JAK3 Inhibitor for T Cell-Mediated Diseases (Investigational Drug Candidate) 24

  25. Slide 25: ATI-2138: Oral Covalent ITK & JAK3 Inhibitor

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) ATI-2138: Oral Small Molecule Covalent IL-2-Inducible Tyrosine Kinase (ITK) & JAK3 Inhibitor for Autoimmune Disease 25 1. Data on file. • ATI-2138 is an investigationa

  26. Slide 26: ATI-2138: Fast Follower and Best-in-Class Potential vs Ritlecitinib

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) • Ritlecitinib approved in Alopecia Areata • ATI-2138 is 44.4x more potent than ritlecitinib for inhibiting αCD3 induced IFNγ production (ITK) and 5.4x more potent for

  27. Slide 27: ATI-2138 and CPI-818 (Soquelitinib) Potency Comparison

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) ATI-2138 and CPI-818 (Soquelitinib) Potency Comparison 27 0 0.01 0.1 1 3 10 0 200 400 600 800 CPI-818_IL13 CPI-818 [uM] % untreated control 0 0.01 0.1 1 0 50 100 150 A

  28. Slide 28: ATI-2138 Pharmacokinetic Analysis from MAD Study

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) 28 ATI-2138 Pharmacokinetic Analysis from MAD Study Exhibited Linear PK and Targeted Exposure • Day 15 plasma concentration curves demonstrated linear PK for ATI-2138

  29. Slide 29: ATI-2138 MAD Exploratory Pharmacodynamics Dose Response

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) ATI-2138 MAD Exploratory Pharmacodynamics Dose Response Data (BID Cohorts) • Pharmacodynamic biomarkers - Ex-vivo stimulation of whole blood taken from subjects before

  30. Slide 30: Rationale for Dual Inhibition of ITK and JAK3

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) • ITK Inhibition Atopic dermatitis (AD) is a Th2 cell driven disease and ITK inhibition blocks Th2 cell differentiation/activation and production of IL-4 and IL-13 •

  31. Slide 31: Phase 2a Trial Design of ATI-2138 in Atopic Dermatitis

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Phase 2a Trial Design of ATI-2138 in Atopic Dermatitis Dosing underway 31 • Open label design • Total 12 weeks treatment • 10mg BID dosing • Safety, PK • PD: RNA analy

  32. Slide 32: ATI-2138 Summary

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) ATI-2138 Summary: Combined IL-2-Inducible Tyrosine Kinase (ITK) & JAK3 Inhibitor for Autoimmune Disease 32 The unique pharmacological profile of ATI-2138 provides oppo

  33. Slide 33: Next Generation Selective ITK Inhibitor

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Confidential Next Generation Selective ITK Inhibitor 33

  34. Slide 34: Selective ITK Inhibition Impacts Th2 Mediated Disease

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) 34 Selective ITK Inhibition Impacts Th2 Mediated Disease ITK Skews T Helper Cell Differentiation Towards Th2 and Th17 Phenotypes • ITK has a nonredundant role in the d

  35. Slide 35: Company Summary

    © Copyright 2024 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2020 Aclaris Therapeutics, Inc. All rights reserved (XX) Company Summary Proven track record of R&D, business development and scientific leadership in immuno-inflammatory diseases Proprietary discovery engine enables targete

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