Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Investor Presentation (April 2019)
35 slides from Aclaris Therapeutics's investor presentation, Apr 4, 2019
Slide 1: Company Overview
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Company Overview Dr. Neal Walker President and CEO April 2019 EMPOWERING PATIENTS THROUGH REVELATIONARY SCIENCE
Slide 2: Cautionary Note Regarding Forward-Looking Statements
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved 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 Securiti
Slide 3: Corporate Strategy: Building a Fully-Integrated Biopharmaceutical Company
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved LEADERSHIP • Physician-founded • Key leadership with track record of executing across multiple development and commercial stage companies • Kinome experts - chemists and bio
Slide 4: Pipeline
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Pipeline Program Indication(s) Preclinical Phase 1 Phase 2 Phase 3 A-101(45%) Topical Common Warts ATI-502 JAK1/JAK3 Inhibitor Topical Alopecia Areata Vitiligo Androgenetic
Slide 5: Conditions with Significant Treatment Gaps
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Conditions with Significant Treatment Gaps *Includes all types of SKs 1Bickers et al. The Burden of Skin Disease. J Am Acad Dermatology. 2006;55:490-500.2Data on file, Aclar
Slide 6: Commercial Portfolio
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved COMMERCIAL PORTFOLIO RHOFADE® (oxymetazoline HCl) cream, 1% ESKATA® (hydrogen peroxide) topical solution, 40% (w/w) 6
Slide 7: RHOFADE Cream
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved RHOFADE Cream • National Rosacea Society estimates more than 16 million Americans are affected by rosacea1 • Persistent facial redness is the most common sign or symptom of
Slide 8: ESKATA
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved 8 ESKATA • Moved to second position in the detail schedule • Sales team focused on top 10 ESKATA accounts based on productivity in each territory, with the objective of incr
Slide 9: A-101 (hydrogen peroxide) 45% Topical Solution for Common Warts
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved A-101 (hydrogen peroxide) 45% Topical Solution Phase 3 Candidate For Common Warts 9
Slide 10: Common Warts - Patient/Physician Surveys
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved 10 Common Warts - Patient/Physician Surveys People with Common Warts in the US 1Data on file, Aclaris Therapeutics, Inc. 2Nguyen et al. Laser Treatment of Nongenital Verruca
Slide 11: Common Warts: Treatment Paradigm
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Conservative Treatments Aggressive Treatments OTC: • Freezing products • Salicylic Acid Rx Topicals: • Imiquimod • Retinoids Cryosurgery In-office Destruction: • Excision •
Slide 12: Summary of WART-203 Phase 2 Trial Results
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Primary Endpoint: • Mean change from baseline in the Physician’s Wart Assessment (PWA)™ score on target wart at day 56 (visit 10) using an analysis of covariance. Secondary
Slide 13: WART-203: Percentage of All Treated Warts Clear
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved 0.0% 2.1% 7.4%* 12.2%** 16.1%** 22.2%*** 25.3%*** 30.2%*** 35.0% 34.3% 39.2% 0.7% 0.7% 1.4% 2.1% 2.9% 5.7% 8.5% 9.2% 11.2% 13.7% 17.2% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0
Slide 14: WART-203: Proportion of Subjects with All Warts Clear
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved 0.0% 1.3% 2.5% 6.4%* 6.3% 11.7%* 15.4%** 19.0%*** 24.0% 28.0% 33.3% 0.0% 0.0% 0.0% 0.0% 1.3% 2.6% 2.6% 2.6% 4.0% 6.8% 7.9% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0
Slide 15: Inflammation and Immunology Platform
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Inflammation and Immunology Platform 15
Slide 16: KINect Platform – Developing Better Kinase Drug Candidates
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved KINect™ Platform – Developing Better Kinase Drug Candidates Rapidly & Efficiently Proprietary Portfolio • Project 1 • Project 2 • Project 3 Strategic Partner(s) • Project 1
Slide 17: Creating New Medicines Targeting Previously Inaccessible Parts of the Kinome
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Creating New Medicines Targeting Previously Inaccessible Parts of the Kinome Kinase Drugs Represented $240B in Aggregate Global Sales from 2011-20151 Proprietary chemical li
Slide 18: ATI-501 and ATI-502 – Selective JAK 1/3 Inhibitor
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved ATI-501 (oral) and ATI-502 (topical) – Selective JAK 1/3 inhibitor Additional topical JAK inhibitors in development • Known MOA and observed biological response in humans •
Slide 19: Mechanism of JAK Inhibitors in Alopecia Areata
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Divito & Kupper, Nature Medicine 20, 989–990 (2014). Mechanism of JAK Inhibitors in Alopecia Areata Christiano Laboratory, Columbia University HF of an AA patient Control In
Slide 20: ATI-502 Topical Proof of Concept
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved ATI-502-AUATB-201 – Topical Proof of Concept Baseline Follow up 33/M 23/F 45/F (250 Days on Drug) (268 Days on Drug) (250 Days on Drug with a 47 day gap) *Hair regrowth cont
Slide 21: Alopecia Areata - Patient/Physician Surveys
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Alopecia Areata - Patient/Physician Surveys Patients with Alopecia Areata in the US 5 –7 M1,2 treated by Primary Care Physicians (6.7 avg. visits)1 treated by Dermatologists
Slide 22: Spectrum of Hair Loss
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Spectrum of Hair Loss 24% 43%34% 51% 100% • 25-52% of patients have persistent patchy AA1 • 14-25% of patients progress to alopecia totalis or universalis1 1MacDonald, et al
Slide 23: Current Treatment Paradigm
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Current treatment paradigm https://www.naaf.org/alopecia-areata/alopecia-areata-treatments. Last accessed March 30, 2019. 23
Slide 24: Alopecia Areata: Potential Treatment Paradigms
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Topical Treatments Systemic Treatments Oral JAK inhibitor Adult / Pediatric Patchy AA Adult AT/AU patients Alopecia Areata: Potential Treatment Paradigms Topical JAK inhibit
Slide 25: Androgenetic Alopecia (AGA)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Androgenetic Alopecia (AGA) 25
Slide 26: Androgenetic Alopecia: Male/Female Pattern Hair Loss
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved • AGA is a genetic disorder and the most common cause of hair loss1 • Experienced by 70% of men and 40% of women at some point in their lives1; affects ~50 million men and ~
Slide 27: ATI-450 (MK2 Inhibitor)
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved ATI-450 (MK2 Inhibitor) 27
Slide 28: MK2 Pathway Inhibitor ATI-450
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved • Pharmacologically unique MOA • MK2 pathway inhibitors target the production and activity of key inflammatory cytokines including TNFα, IL-1α, IL-1β and IL-6 • ATI-450 inhi
Slide 29: MK2-driven cytokines are central to many diseases
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved MK2-driven cytokines are central to many diseases 29 TNFα, IL1β, IL6 Psoriasis / psoriatic arthritis Neuroinflammation Inflammatory bowel disease Rheumatoid arthritis / Juve
Slide 30: ATI-450 Inhibits Expression of Key Inflammatory Cytokines
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved INFLAMMATION ATI-450 does NOT block the activation of anti-inflammatory pathways (e.g., IL-10) thereby preserving this homeostatic dampening of the immune response p38α MK2
Slide 31: Mouse LPS-Induced TNFa Production
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Mouse LPS-Induced TNFa Production ATI-450 demonstrated durable response (no tachyphylaxis) • Conventional p38 (CDD-111) and MK2PI (ATI- 450) administered to mice in feed sta
Slide 32: In vivo Results of MK2 Pathway Inhibitor ATI-450
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved In vivo Results of MK2 Pathway Inhibitor ATI-450 Normal Vehicle 450 (5 mpk) Joint Protection in Rat Arthritis Model1 Cytokine Modulation in Orphan Autoinflammatory Disease (
Slide 33: Fully Integrated Biopharmaceutical Company
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Fully Integrated Biopharmaceutical Company Strong Cash Position $168 million as of December 31, 2018 Commitment to Patients Focus on “white-space” or underserved diseases wh
Slide 34: Milestones 2019-2020
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Milestone 2019 2020 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 A-101 45% Common Warts Phase 3 Data Submit NDA ATI-501/ATI-502 (Oral/Topical JAK Inhibitor) ATI-501 - Phase 2 AT/AU Dose Range Da
Slide 35: Thank You
© Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved THANK YOU
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