Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Investor Presentation (May 2025)
33 slides from Aclaris Therapeutics's investor presentation, May 8, 2025
Slide 1: Corporate Overview May 2025
Corporate Overview May 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 Potential
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: 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: Rich Clinical Catalyst Calendar
5 Rich Clinical Catalyst Calendar 2025 ATI-052 IND Clearance by FDA Bosakitug Initiation of Phase 2 in Atopic Dermatitis Second Quarter 2025 ATI-052 Initiation of Phase 1a/1b Trial Second Quarter 2025 ATI-2138 Atopic Dermatitis Ph. 2 Top Line Data June 2025 2026 ATI-045 Atopic Dermatitis Ph. 2 Top L
Slide 6: Bosakitug (ATI-045) Anti-TSLP Monoclonal Antibody Program
6 Bosakitug (ATI -045) Anti -TSLP Monoclonal Antibody Program Investigational Drug Candidate
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 (ATI-045) Unique Differentiation
8 Bosakitug (ATI -045) Unique Differentiation Best-in-Class Potential
Slide 9: Bosakitug Key Properties
9 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 10: Dissociation Kinetics and Residence Time
10 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 diss
Slide 11: Bosakitug Has Greater Potency Than Other TSLP/TSLPR Antibodies
11 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 The bifunctional antibody, ATI-052, retains much of the potency for TSLP functional blockade
Slide 12: Bosakitug Competitively Positioned as Potential Best-in-Class TSLP mAb
12 Bosakitug Competitively Positioned as Potential Best-in-Class TSLP mAb • Strong differentiation vs. tezepelumab and other clinical stage anti-TSLP mAbs – Slower dissociation rate – Very high residence time – Greater potency • Unique binding characteristics • Opportunity for extended dosing • Clin
Slide 13: Bosakitug (ATI-045) Atopic Dermatitis Program
13 Bosakitug (ATI -045) Atopic Dermatitis Program Potential First-in-Class TSLP mAb for AD
Slide 14: Clinical Translation: Bosakitug Phase 2a POC Monotherapy
14 Clinical Translation: Bosakitug Phase 2a (US-Based) POC Monotherapy PRIMARY OBJECTIVES • To evaluate the efficacy, safety and tolerability of bosakitug as monotherapy in subjects with moderate to severe AD SECONDARY OBJECTIVES • To evaluate the pharmacokinetics, immunogenicity and pharmacodynamic
Slide 15: Bosakitug Exposure and Efficacy Time Profile
15 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 16: Bosakitug Demonstrated Improvement in Efficacy Measures
16 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 17: Comparison to Dupilumab Mono, Combo, and Tezepelumab Combo Studies
17 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 18: Next Steps with Bosakitug
18 Next Steps with Bosakitug • Preclinical and clinical data generated to date reinforce the enhanced potency of bosakitug and support further development in dermatological conditions • Aclaris intends to initiate a two-arm placebo-controlled Phase 2 trial of bosakitug in atopic dermatitis (AD) in t
Slide 19: ATI-052: Anti-TSLP x IL-4R Bispecific Antibody Program
19 ATI-052: Anti -TSLP x IL-4R Bispecific Antibody Program Investigational Drug Candidate
Slide 20: ATI-052: Key Asset Highlights
20 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 – Anti-TSLP mAb component has Fc engineered to bind m
Slide 21: ATI-052 Demonstrates Greater Potency than Tezepelumab and Dupilumab Combination
21 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 22: Next Steps with ATI-052
22 Next Steps with ATI -052 • IND cleared by US Food and Drug Administration (April 2025) • Phase 1a/1b trial expected to start in 2Q25 – Single and multiple ascending doses of ATI-052 – Followed by a proof-of-concept portion in an undisclosed indication
Slide 23: ATI-2138: A First-Generation Novel ITK/JAK3 Inhibitor
23 ATI-2138: A First-Generation Novel ITK/JAK3 Inhibitor for T Cell -Mediated Diseases Investigational Drug Candidate
Slide 24: ATI-2138: Oral Covalent ITK & JAK3 Inhibitor for Autoimmune Disease
24 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 25: ATI-2138: Fast Follower and Best-in-Class Potential vs Ritlecitinib
25 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 26: ATI-2138 and CPI-818 (Soquelitinib) Potency Comparison
26 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 27: Rationale for Dual Inhibition of ITK and JAK3
27 Rationale for Dual Inhibition of ITK and JAK3 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 – Dupilumab (anti-IL4Ra) and tralokinumab (anti-IL-13) are efficacious in AD • Topical
Slide 28: Phase 2a Trial Design of ATI-2138 in Atopic Dermatitis
28 Phase 2a Trial Design of ATI-2138 in Atopic Dermatitis Eligibility Treatment Endpoints Dosing Complete in Single Arm Open -Label Trial • Open-label design • Total 12 weeks treatment • 10mg BID dosing • Safety, PK • PD: RNA analysis, proteomics, IHC to analyze specific pathway inhibition • EASI-50
Slide 29: Next Steps with ATI-2138
29 Next Steps with ATI -2138 Alopecia Areata IBD Vitiligo Atopic Dermatitis Dosing Complete in Ph2a cGvHD Genital Psoriasis Acute Inflamm atory Psoriasis Asthma RA Crohn’s Disease Ulcerative Colitis Psoriatic Arthritis Atopic Dermatitis Palmoplant ar Pustulosis Alopecia Areata Peripheral T cell Lymp
Slide 30: Next-Generation Selective ITK Inhibitor
30 Next-Generation Selective ITK Inhibitor
Slide 31: Selective ITK Inhibition Impacts Th2 Mediated Disease
31 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 • Goal of next g
Slide 32: Company Summary
32 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 33: May 2025 Corporate Overview
May 2025 Corporate Overview EMPOWERING PATIENTS THROUGH THERAPEUTIC INNOVATION
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