Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Investor Presentation (June 2025)
31 slides from Aclaris Therapeutics's investor presentation, Jun 30, 2025
Slide 1: Corporate Overview June 2025
Corporate Overview June 2025 EMPOWERING PATIENTS THROUGH THERAPEUTIC INNOVATION
Slide 2: Disclaimer and Cautionary Note Regarding Forward-Looking Statements
2 Disclaimer and Cautionary Note Regarding Forward -Looking Statements 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 b
Slide 3: Aclaris Therapeutics: Opportunities for Significant Growth
3 Strong balance sheet expected to fund operations through the first half of 2028 Current cash runway expected to fully fund preclinical and clinical development plans Potential opportunities for additional non-dilutive financing and development partners Bosakitug (ATI-045): Uniquely potent monoclon
Slide 4: Broad Immunology Development Pipeline
4 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PARTNER Bosakitug (ATI-045) TSLP mAb Subcutaneous Atopic Dermatitis (moderate-to-severe) Severe Asthma CTTQ (China)* Chronic Rhinosinusitis with Nasal Polyps CTTQ (China)* COPD CTTQ (China)* ATI-2138 ITK/JAK3 Inhibitor Oral Atopic Dermatitis (moderate-to-severe)
Slide 5: Executing on Rich Clinical Catalyst Calendar
5 Executing on Rich Clinical Catalyst Calendar 2025 ATI-052 IND Clearance by FDA Bosakitug (ATI-045) Initiation of Phase 2 Trial in Atopic Dermatitis ATI-052 Initiation of Phase 1a/1b Program ATI-2138 Atopic Dermatitis Phase 2a Top Line Data July 2025 ATI-052 Completion of dosing in Phase 1a SAD/MAD
Slide 6: Bosakitug (ATI-045) Anti-TSLP Monoclonal Antibody Program
6 Bosakitug (ATI -045) Anti -TSLP Monoclonal Antibody Program Differentiated Investigational Drug Candidate with Best-In-Class Potential
Slide 7: TSLP Overview
7 TSLP Overview • Bosakitug is a humanized monoclonal antibody targeting thymic stromal lymphopoietin (TSLP) • TSLP - Pleiotropic and broad activity – Master regulator of type 2 (Th2) immune responses at the barrier surfaces of skin and the respiratory/ gastrointestinal tract – Drives eosinophilic a
Slide 8: Bosakitug Key Properties
8 Bosakitug Key Properties • Very high affinity to TSLP • Extremely low dissociation rate from TSLP*, leading to long residence time and enhanced neutralization activity • Very high potency • Unique binding characteristics to TSLP • ~23-day half-life that can potentially support an extended dosing i
Slide 9: Dissociation Kinetics and Residence Time
9 Dissociation Kinetics and Residence Time Residence Time (hours) Dissociation of TSLP from mAbs (TR-FRET) 416 402 14.3 8.11 22.1 3.59 20.7 ATI-052 ATI-045 Tezepelumab** Solrikitug/MK-8226** GSK-5784283 V2 (hu179-33)* GSK-5784283 V1 (hu3-13)* UPB-101 Bosakitug and ATI-052 demonstrate very slow disso
Slide 10: Bosakitug Has Greater Potency Than Other TSLP/TSLPR Antibodies
10 Bosakitug Has Greater Potency Than Other TSLP/TSLPR Antibodies TSLP Stimulated CCL17 Production from hPBMC Bosakitug is the most potent of the TSLP/TSLPR antibodies evaluated in blocking CCL17 production ATI-052 retains much of the potency for TSLP functional blockade compared with the parent bos
Slide 11: Clinical Translation: Phase 2a POC Monotherapy
11 Clinical Translation: Phase 2a (US -Based) POC Monotherapy Enrolled: 22 subjects (17 completed treatment) at 7 US-based sites Eligibility: Diagnosis of AD (present for at least 6 months); EASI ≥12; IGA ≥3; total AD BSA ≥10% Baseline Characteristics: Mean EASI of 17.6, Mean PP-NRS of 6.5; majority
Slide 12: Bosakitug Exposure and Efficacy Time Profile
12 Bosakitug Exposure and Efficacy Time Profile Demonstrated Sustained Clinical Response After the Last Dose • 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 dose supports the possi
Slide 13: Bosakitug Demonstrated Improvement in Efficacy Measures
13 Bosakitug Demonstrated Improvement in Efficacy Measures (Week 26, N=17) EASI 75 % @ Week 26 EASI 90 % @ Week 26 EASI 100 % @ Week 26 IGA 0/1 @ Week 26 94% 65% 24% 88% Data on file % of Patients Achieving Clinical Endpoint Time (Week) 0 10 20 30 40 50 60 70 80 90 100 0 4 8 12 16 20 24 28 32 36 EAS
Slide 14: Comparison to Dupilumab Mono, Combo, and Tezepelumab Combo Studies
14 Comparison to Dupilumab Mono, Combo, and Tezepelumab Combo Studies** 1. N Engl J Med. 2016 Dec 15;375(24):2335-2348. [SOLO1:NCT02277743; SOLO2:NCT02277769]; 2. 16-week study; 3. J Am Acad Dermatol. 2019 Apr;80(4):1013-1021. [NCT02525094]; 4. Lancet. 2017 Jun 10;389(10086):2287-2303. [NCT02260986]
Slide 15: Global Phase 2 Monotherapy Trial Underway
15 Global Phase 2 Monotherapy Trial Underway PRIMARY OBJECTIVE (WEEK 24) • To evaluate the efficacy of bosakitug compared to placebo, as measured by the change in Eczema Area and Severity Index (EASI) score in patients with moderate-to-severe AD SECONDARY OBJECTIVES (WEEK 24) • To evaluate the treat
Slide 16: Next Steps with Bosakitug
16 Next Steps with Bosakitug • Competitively positioned as potential best-in-class TSLP mAb. Preclinical and clinical data generated to date reinforce the enhanced potency of bosakitug and support further development in dermatological conditions • Two-arm placebo-controlled Phase 2 trial of bosakitu
Slide 17: ATI-052: Anti-TSLP x IL-4R Bispecific Antibody Program
17 ATI-052: Anti -TSLP x IL-4R Bispecific Antibody Program Highly Potent and Bioactive Investigational Drug Candidate
Slide 18: ATI-052: Key Asset Highlights
18 ATI-052: Key Asset Highlights • Potential best-in-class bispecific anti-TSLP/IL-4R mAb – Bispecific utilizing same antibody binding regions of ATI-045 combined with IL-4R, inhibiting TSLP upstream and immune cells downstream of the Th2 cascade – Retains dissociation kinetics, residence time, and
Slide 19: ATI-052 Demonstrates Greater Potency than Tezepelumab and Dupilumab Combination
19 ATI-052 Demonstrates Greater Potency than the Combination of Tezepelumab and Dupilumab on CCL17 Release • ATI-052 is 3-5x more potent than the combination of Tezepelumab + Dupilumab Effect on CCL17 Release Induced by 0.1 ng/mL IL4 plus 0.1 ng/mL TSLP Ab Concentration (nM) 140 120 100 80 60 40 20
Slide 20: Placebo Controlled Phase 1a/1b Program Underway
20 Placebo Controlled Phase 1a/1b Program Underway PRIMARY OBJECTIVE • To evaluate the safety and tolerability of ATI-052 SECONDARY OBJECTIVES • To evaluate the pharmacokinetics (PK) of ATI-052 • To evaluate the immunogenicity of ATI-052 EXPLORATORY OBJECTIVES • To evaluate the activity of ATI-052 i
Slide 21: Next Steps with ATI-052
21 Next Steps with ATI -052 • IND cleared by US Food and Drug Administration (April 2025) • Phase 1a/1b program underway – Dosing in Phase 1a SAD/MAD portion expected to be complete by year-end 2025 followed by top line results in early 2026 – Top line results from expected Phase 1b POC portion anti
Slide 22: ATI-2138: A First-Generation Novel ITK/JAK3 Inhibitor
22 ATI-2138: A First-Generation Novel ITK/JAK3 Inhibitor for T Cell -Mediated Diseases Potent and Selective Investigational Drug Candidate with Strong Tolerability Profile
Slide 23: ATI-2138: Oral Covalent ITK & JAK3 Inhibitor for Autoimmune Disease
23 ATI-2138: Oral Small Molecule Covalent IL -2-Inducible Tyrosine Kinase (ITK) & JAK3 Inhibitor for Autoimmune Disease • Investigational oral compound which interrupts T cell receptor (TCR) signaling by inhibiting ITK and JAK3 signaling of common γ chain cytokines in lymphocytes (including IL-2 & I
Slide 24: ATI-2138: Fast Follower and Best-in-Class Potential vs Ritlecitinib
24 ATI-2138: Fast Follower and Best-in-Class Potential vs Ritlecitinib • 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 inhibiting JAK3 dependent IL-2 induced IFNγ production in hum
Slide 25: ATI-2138 and CPI-818 (Soquelitinib) Potency Comparison
25 ATI-2138 and CPI-818 (Soquelitinib ) Potency Comparison • ATI-2138 is 15-38x more potent than CPI-818 in inhibiting the ITK enzyme activity • ATI-2138 is significantly more potent than CPI-818 in blocking the Th2 derived cytokines, IL4, IL-5 and IL-13 (~100x) 0 0.01 0.1 1 3 10 0 200 400 600 800 C
Slide 26: ATI-2138 Phase 2a Trial Design in Atopic Dermatitis
26 ATI-2138 Phase 2a Trial Design in Atopic Dermatitis Single Arm Open -Label Trial: Complete; Awaiting PD Results Screening ~30 days Follow-up 2 weeks ATI-2138 (10mg BID) Treatment Period: 12 Weeks Week 12 Efficacy endpoint analysis 14 enrolled patients Moderate-to-Severe Atopic Dermatitis PRIMARY
Slide 27: Next Steps with ATI-2138
27 Next Steps with ATI -2138 • Single arm Phase 2a open-label trial of ATI-2138 complete – Tolerability and efficacy results received – Awaiting PD results from external vendor; top line results expected in July 2025 • Potential future target indications under consideration include alopecia areata a
Slide 28: Next-Generation Selective ITK Inhibitor
28 Next-Generation Selective ITK Inhibitor
Slide 29: Selective ITK Inhibition Impacts Th2 Mediated Disease
29 Selective ITK Inhibition Impacts Th2 Mediated Disease • ITK has a nonredundant role in the differentiation and activation of TH2 and TH17 cells • Blockade of TH2 function inhibits production of IL-4 & IL-13, two cytokines with demonstrated importance in atopic & allergic diseases Adapted from J S
Slide 30: Company Summary
30 Company Summary * Without giving effect to additional business development transactions or financing activities. Proven track record of R&D, business development and scientific leadership in immuno-inflammatory diseases Proprietary discovery engine enables targeted design of novel drug candidates
Slide 31: June 2025 Corporate Overview
June 2025 Corporate Overview EMPOWERING PATIENTS THROUGH THERAPEUTIC INNOVATION
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