Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Investor Presentation (July 2016)
19 slides from Aclaris Therapeutics's investor presentation, July 2016
Slide 1: Company Overview
Company Overview Dr. Neal Walker President and CEO July 2016 © Copyright 2016 Aclaris Therapeutics. All rights reserved. A-1 1
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements, including statements regarding the treatment and market opportunity for SK, common warts, alopecia areata, androgenetic alopecia, vitiligo, and the future operations of Aclaris. These statements involve substantial known and unknown r
Slide 3: The Aclaris Opportunity
The Aclaris Opportunity MANAGEMENT TEAM ATTRACTIVE DRUG DEVELOPMENT EXPERTISE IN DERMATOLOGY PIPELINE DERMATOLOGY MARKETS • Founded and sold several A-101: Proprietary formulation • Time and capital efficient companies of high concentration H2O2 • Seborrheic Keratosis • Highly concentrated • Directl
Slide 4: Our Drug Candidates
Our Drug Candidates Exclusive, Worldwide Right to Commercialize A-101, A-102, ATI-50001 and ATI-50002 RESEARCH PRE-CLINICAL PHASE I PHASE II PHASE III A-101* Seborrheic Keratosis (topical) ** Common Warts (topical) *** ATI-50001 Alopecia Areata (oral) ATI-50002 Alopecia Areata (topical) Also develop
Slide 5: Seborrheic Keratosis (SK) Background
Seborrheic Keratosis (SK) Background • SK is one of most common diagnoses made by dermatologists − >83 million people with the disease in the U.S. − 18.5 million patient visits to dermatologists − 8.3 million procedures to remove SKs annually − $1.2 billion - historic costs of treatments for SK • Pa
Slide 6: Potential to Be First FDA-approved Drug for SK
Potential to Be First FDA-approved Drug for SK UNTREATED TREATED A-101 is appealing concept for SK treatment • Topical, non-invasive • Minimal discomfort; no need for anesthesia • Reduced risk of pigmentary changes and scarring • Ability to treat larger numbers of lesions • Ability to hand off to an
Slide 7: Summary of Completed Phase 2 Trials for SK
Summary of Completed Phase 2 Trials for SK SK Lesion Trial Date Completed Trial Design Trial Outcome Area Single center, intra-subject Four lesions treated Efficacy: 32.4% clear; 67.7% clear SEBK-201 or near clear with 40% A-101 concentrations: (n=35) Trunk (Back) June 2014 concentration 25.
Slide 8: A-101 Phase 2 Trunk/Extremities Study: PLA Responder Analysis
A-101 Phase 2 Trunk/Extremities Study: PLA Responder Analysis Percentage of Subjects Achieving Percentage of Subjects Achieving Total Clearance Total Clearance or Near Clearance 70.0% 60.0% 50.0% 20.0% 40.0% * 15.0% * 30.0% * * 58.9% 10.0% * * 19.6% * 42.4% 20.0% 14.3% 16.1% * 32.6% 5.0% 10.0% 23.7%
Slide 9: A-101 Phase 2 Face Study: PLA Responder Analysis
A-101 Phase 2 Face Study: PLA Responder Analysis Percentage of Subjects With Target Lesion Percentage of Subjects With Target Lesion Clear Clear or Near-Clear 70.0% 70.0% 60.0% 60.0% 50.0% 50.0% 40.0% 40.0% * 67.6% 30.0% * 60.0% 30.0% * 61.5% * * 46.0% * 45.9% 20.0% 20.0% * * 33.3% 28.0% 10.0% * 24.
Slide 10: Grading of SKs using PLA Scale in Clinical Trials
Grading of SKs using PLA Scale in Clinical Trials Pre-Treatment with A-101 Post-Treatment with A-101 Subject: Subject:04-52 04-92 Subject: 04-52 Visit: Visit:22 Visit:Subj 8 04-92 Date: Date:Visit: 8 Date: 17Jul2014 07Jul2014 Lesion: 1 23Oct2014 30Oct2014 Date: Lesion: 3 Lesion: Lesion: 3 1 H2O2%:40
Slide 11: A-101 Next Steps: Phase 3 Overview
A-101 Next Steps: Phase 3 Overview • A-101 40.0% is being used for Phase 3 clinical testing • Initiated Phase 3 program – January 2016 • Pivotal trials (SEBK-301/302): Two identical Phase 3 trials − 4 lesions treated in total with at least one on face and one on trunk or extremities − 400 subjects e
Slide 12: A-101 Commercialization Strategy
A-101 Commercialization Strategy • Cash pay, minimally invasive procedure Buy and Bill Model • Lower cost relative to other aesthetic treatments (Botox®, Fillers, Laser treatments) Concentrated • 5,000 dermatologists in US, accounting for over 70% of procedures performed Prescriber Base • Concentrat
Slide 13: ATI-50001/ATI-50002 Candidates for Alopecia Areata
ATI-50001/ATI-50002 Candidates for Alopecia Areata July 2016 13
Slide 14: Alopecia Areata (AA) Background
Alopecia Areata (AA) Background • AA is an autoimmune condition, characterized by patchy, non- scarring hair loss on the scalp and body • Large unmet need: >6.6 million people in the U.S. have had or will develop AA at some point in their lives − 2/3 of affected individuals ≤30 years old at disease
Slide 15: ATI-50001/ATI-50002: JAK Inhibitors in Alopecia Areata
ATI-50001/ATI-50002: JAK Inhibitors in Alopecia Areata • Lead asset: Selective JAK 1/3 inhibitor from Rigel − Exclusive, worldwide license and development collaboration − Oral and topical rights • Known mechanism of action and biological response in humans • Promoted hair regrowth in mouse model of
Slide 16: Recent Business Development Transactions
Recent Business Development Transactions • Vixen (Columbia University IP) and Key Organics/JAKPharm • Broadens our IP estate • Methods of use covering JAK inhibitors for the treatment of: • Alopecia Areata • Androgenetic alopecia (female and male pattern hair loss) • Additional hair loss disorders •
Slide 17: Indication expansion
Indication expansion • Androgenic alopecia (male and female pattern hair loss) • AGA is the most common cause of hair loss and is experienced by 70% of men and 40% of women at some point in their lives • In 2012, 35 million men and 21 million women suffered hair loss Male with AGA • Topical JAK inhi
Slide 18: Near-Term Milestones
Near-Term Milestones 2016 2017 Milestone Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 A-101 SK Phase 3 Trial Initiated Submit NDA A-101 Common Warts Phase 2 Trial Underway ATI-50001/ATI-50002 Alopecia Areata Submit IND Commence Clinical Trial July 2016 18
Slide 19: Thank You
THANK YOU www.aclaristx.com 19 © Copyright 2016 Aclaris Therapeutics. All rights reserved.
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