Aclaris Therapeutics, Inc. · NASDAQ:ACRS
Aclaris Therapeutics — Investor Presentation (September 2016)
27 slides from Aclaris Therapeutics's investor presentation, Sep 13, 2016
Slide 1: Company Overview
© Copyright 2016 Aclaris Therapeutics. All rights reserved. A-1 Company Overview 1 Dr. Neal Walker President and CEO September 2016
Slide 2: 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 risks, uncer
Slide 3: The Aclaris Opportunity
The Aclaris Opportunity 3 Time and capital efficient Highly concentrated prescriber base Large unmet market segments with no FDA-approved drugs Growing market for cash pay aesthetic and medical dermatology products A-101: Proprietary formulation of high concentration H2O2 Seborrheic Keratosis Phase
Slide 4: Our Drug Candidates
Our Drug Candidates Exclusive, Worldwide Right to Commercialize A-101, A-102, ATI-50001, ATI-50002, and ATI-50003. 4 Seborrheic Keratosis (topical) A-101* RESEARCH PRE-CLINICAL PHASE I PHASE II PHASE III Common Warts (topical) ATI-50001 Alopecia Areata (oral) ATI-50002 Alopecia Areata (topical,oral)
Slide 5: Seborrheic Keratosis (SK) Background
3 Months Post Cryosurgery Before Treatment 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 Patients
Slide 6: A-101 is appealing concept for SK treatment
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 ancillary staff Background Developed a proprietary formulation of 40.0% H2O2
Slide 7: Summary of Completed Phase Trials for SK
Summary of Completed Phase 2 Trials for SK Trial SK Lesion Area Date Completed Trial Design Trial Outcome SEBK-201 (n=35) Phase 2 Trunk (Back) June 2014 Single center, intra-subject Four lesions treated A-101 concentrations: 25.0%, 32.5%, 40.0% 1 or 2 applications Duration: 78 days Efficacy: 32.4% c
Slide 8: A-101 Phase Trunk/Extremities Study: PLA Responder Analysis
A-101 Phase 2 Trunk/Extremities Study: PLA Responder Analysis * 8 September 2016
Slide 9: A-101 Phase Face Study: PLA Responder Analysis
A-101 Phase 2 Face Study: PLA Responder Analysis Percentage of Subjects With Target Lesion Clear Percentage of Subjects With Target Lesion Clear or Near-Clear * * * P-value<0.001 9 * P-value<0.001 September 2016 0.0% 3.0% 28.0% 46.0% 24.0% 60.0% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% Day 22
Slide 10: Grading of SKs using PLA Scale in Clinical Trials
Grading of SKs using PLA Scale in Clinical Trials Subject: 04-52 Visit: 8 Date: 23Oct2014 Lesion: 3 H2O2%: 40.0 PLA: 1 Subject: 04-52 Visit: 2 Date: 07Jul2014 Lesion: 3 H2O2%: 40.0 PLA: 3 Subject: 04-52 Visit: 2 Date: 07Jul2014 Lesion: 4 H2O2%: 40.0 PLA: 3 Subj 04-92 Visit: 8 Date: 30Oct2014 Lesion:
Slide 11: 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 Primary endpoint: Proportion of subjects with clear on PLA
Slide 12: A-101 Commercialization Strategy
12 A-101 Commercialization Strategy September 2016 Cash pay, minimally invasive procedure Lower cost relative to other aesthetic treatments (Botox®, Fillers, Laser treatments) Buy and Bill Model 5,000 dermatologists in US, accounting for over 70% of procedures performed Concentrated call point allow
Slide 13: A-101 Candidate for Common Warts
A-101 CANDIDATE FOR COMMON WARTS September 2016 13
Slide 14: Existing Patient Base Offers Significant Market Potential
September 2016 14 Existing Patient Base Offers Significant Market Potential 1 IMS National Disease and Therapeutic Index 2016. 2 Bruggnik et al, Natural Course of Cutaneous Warts Among Primary Schoolchildren: A Prospective Cohort Study 2013, Annals of Family Medicine;11:5,2013;437-441. 3 Lipke M., A
Slide 15: Summary of A-101 Phase 2 Wart Clinical Trial Results
Trial Common Wart Area Topline Data Trial Objective and Design Trial Outcome WART–201 (n=98) Phase 2 Trunk and Extremities August 2016 Multicenter, parallel group One wart treated A-101 concentrations: 40%, 45% compared to vehicle 8 applications Duration: 56 days Efficacy: Statistically significant
Slide 16: Statistical and Clinical Significance Achieved on Primary Endpoint with A-101 45%
Both Statistical and Clinical Significance Achieved on Primary Endpoint with A-101 45% Concentration MEAN CHANGE FROM BASELINE IN THE PWA SCORE AT VISIT 10 Baseline Day 7Day 14 Day 21 Day 28 Day 35 Day 42 Day 49 Day 56 * p < 0.05 ** p < 0.01 0 -0.2 -0.4 -0.6 -0.8 -1 -1.2
Slide 17: Statistical Significance Achieved on Secondary Endpoints in Clearance of Common Warts
September 2016 17 Statistical Significance Achieved on Secondary Endpoints in Clearance of Common Warts with A-101 45% Concentration Responder Analysis PROPORTION OF SUBJECTS ACHIEVING WART CLEARANCE AT VISIT 10 P- value = 0.02 PROPORTION OF SUBJECTS ACHIEVING CLEAR OR BARELY EVIDENT ON PWA AT VISIT
Slide 18: Patient Treated with A-101 45% Concentration in study WART-201
Patient Treated with A-101 45% Concentration in study WART-201 Subject: 04-52 Visit: 2 Date: 07Jul2014 Lesion: 3 H2O2%: 40.0 PLA: 3 Pre-Treatment with A-101 Post-Treatment with A-101 18 Visit 2 (PLA 3) Visit 10 (PLA 0) September 2016
Slide 19: Skin Reactions Similar to Vehicle at Visit 10; Favorable Safety Profile
Skin Reactions Similar to Vehicle at Visit 10; Favorable Safety Profile No Reaction Mild Moderate September 2016 19 Vesicles/Bullae 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% A-101 Solution 40% A-101 Solution 45% A-101 Solution Vehicle A-101 Solution 40% A-101 Solution 45% A-101 Solution Vehicle A-
Slide 20: A-101 45% Concentration Considered for Further Development for Common Warts
September 2016 20 Based on Results, A-101 45% Concentration Considered for Further Development as Treatment for Common Warts Statistical Significance Achieved both statistical and clinical significance on the primary endpoint Achieved statistical significance in complete clearance of the warts Safet
Slide 21: ATI-50001/ATI-50002 Candidates for Alopecia Areata
ATI-50001/ATI-50002 Candidates for Alopecia Areata 21
Slide 22: 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 onset 25-50% of patients have persisten
Slide 23: 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 AA Drug Candidates: ATI-50001 for oral administration in Alopecia
Slide 24: 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 Next generation JAK inhibitors Covalently bound highly
Slide 25: Additional Potential Indications
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 lives1 In 2012, 35 million men and 21 million women suffered hair loss2 Topical JAK inhibitor Vitiligo Vitiligo impacts 1% to 2%
Slide 26: Milestones
Milestone 2016 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 A-101 SK Phase 3 Trials Initiated Phase 3 Data Submit NDA Submit MAA A-101 Common Warts Phase 2 Data ATI-50001/ATI-50002 Alopecia Areata Submit IND Commence POC trial September 2016 26 Milestones
Slide 27: Thank You
© Copyright 2016 Aclaris Therapeutics. All rights reserved. THANK YOU www.aclaristx.com 27
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