Aclaris Therapeutics, Inc. · NASDAQ:ACRS

Aclaris Therapeutics — Investor Presentation (June 2019)

38 slides from Aclaris Therapeutics's investor presentation, Jun 5, 2019

1. 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 June 2019 EMPOWERING PATIENTS THROUGH REVELATIONARY SCIENCE

2. 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 Securit

3. Slide 3: Leadership and Corporate Strategy

   © 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 bi

4. 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

5. 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, Acla

6. 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

7. 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 erythema (PFE) is the most common sign or sym

8. Slide 8: RHOFADE Exclusivity and Patents

   © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved • Three-year CI market exclusivity until January 18, 2020 • Five Orange Book Patents • USP No. 7,812,049 (Exp 5/2/28 with 1562 days PTA) • Method of treating erythema resul

9. Slide 9: ESKATA

   © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved 9 ESKATA • Moved to second position in the detail schedule • Sales team focused on top ESKATA accounts based on productivity in each territory, with the objective of increa

10. Slide 10: A-101 45% Topical Solution Phase 3 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 (Investigational Drug Candidate) - Phase 3 for the Treatment of Common Warts 10

11. Slide 11: Common Warts - Patient/Physician Surveys

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved 11 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 Verruc

12. Slide 12: 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 •

13. Slide 13: 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

14. Slide 14: 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.

15. Slide 15: WART-203: Subjects with All Treated 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.

16. Slide 16: Inflammation and Immunology Platform

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Inflammation and Immunology Platform 16

17. Slide 17: 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

18. Slide 18: The Kinase Opportunity: Rational Targeted Drug Discovery

    © 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 l

19. Slide 19: ATI-501 and ATI-502 Selective JAK 1/3 Inhibitors

    © 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 •

20. Slide 20: 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 I

21. Slide 21: ATI-502 - Topical Proof of Concept

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved ATI-502 – Topical Proof of Concept Baseline Follow up 33/M 23/F 45/F (334 Days on Drug) (353 Days on Drug) (385 Days on Drug with a 47 day gap) • Of the 8 patients who rece

22. Slide 22: 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 MM 1,2 treated by Primary Care Physicians (6.7 avg. visits)1 treated by Dermatologi

23. Slide 23: 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

24. Slide 24: 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. 24

25. Slide 25: 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 inhibi

26. Slide 26: Androgenetic Alopecia (AGA)

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved Androgenetic Alopecia (AGA) 26

27. Slide 27: 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

28. Slide 28: AGA - New Mechanism of Action Postulated

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved • Tissue-resident immune cells with potent sensing and effector functions are well- placed to fundamentally aid tissue homeostasis via crosstalk with stem cells. • A dermis

29. Slide 29: JAK Intellectual Property Estate

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved • US & Global JAK IP estate consisting of >150 patents/applications (issued and/or pending) • Exclusive license with Rigel Pharmaceuticals for ATI-501 & ATI-502 (COM) in de

30. Slide 30: ATI-450 (MK2 Inhibitor)

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved ATI-450 (MK2 Inhibitor) (Investigational Drug Candidate) 30

31. Slide 31: ATI-450 Development Plan and Mechanism

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved • IND for treatment of RA allowed in May 2019 • Plan to initiate a Single Ascending Dose / Multiple Ascending Dose Phase 1 trial in approximately 80 patients in the second

32. Slide 32: 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 TNFα, IL1β, IL6 Psoriasis / psoriatic arthritis Neuroinflammation Inflammatory bowel disease Rheumatoid arthritis / Juveni

33. Slide 33: ATI-450 Inhibits 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

34. Slide 34: 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 st

35. Slide 35: 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

36. Slide 36: 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 $137 million as of March 31, 2019 Commitment to Patients Focus on “white-space” or underserved diseases wher

37. Slide 37: 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 D

38. Slide 38: Thank You

    © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved © Copyright 2019 Aclaris Therapeutics, Inc. All rights reserved THANK YOU

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