Aclaris Therapeutics, Inc. (ACRS) 10-K Annual Report March 2016

Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage specialty pharmaceutical company, today announced financial results for the fourth quarter and year ended December 31, 2015 and provided an update on its clinical development programs.

“It has been an exciting time for Aclaris since our IPO in October of last year as we have made significant progress with the advancement of our development pipeline. With our lead drug candidate, A-101, in the clinic for two indications (seborrheic keratosis and common warts), we look forward to seeing the results which we anticipate later this year. We also continue to expand our pipeline by adding novel compounds to our clinical program such as our JAK (Janus Kinase) inhibitor compounds for the treatment of alopecia areata and other dermatological conditions. We continue to build a commercial infrastructure and have now assembled a senior management team with over 120 combined years of directly relevant experience in dermatology,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.

Business Highlights and Recent Developments

Initiated Phase 3 Clinical Trials of A-101 for the Treatment of Seborrheic Keratosis. Earlier this year, the company initiated two Phase 3 clinical trials to evaluate A-101 Topical Solution for the treatment of seborrheic keratosis (SK). The two Phase 3 clinical trials will evaluate the safety and efficacy of A-101 Topical Solution compared with a vehicle solution (placebo). Approximately 800 subjects will be randomized in these multi-center, double-blinded, vehicle-controlled clinical trials, which are being conducted at 34 investigational centers within the United States.

Added to the Russell 2000® and Russell 3000® Indexes as part of Russell Investments' annual reconstitution effective as of December 21, 2015.

Appointed Brett Fair as Senior Vice President of Commercial Operations. In December 2015, Mr. Fair joined Aclaris, bringing more than 18 years of pharmaceutical commercialization and business development experience.

Initiated Phase 2 Clinical Trial of A-101 for Treatment of Common Warts. In December 2015, the company initiated a Phase 2 clinical trial to evaluate A-101 Topical Solution for the treatment of common warts (verruca vulgaris). This double-blinded, randomized Phase 2 trial, to be conducted at six sites in the United States, will evaluate the safety, tolerability and dose-response of two concentrations of A-101 compared with a vehicle control. Aclaris intends to enroll approximately 108 subjects in this clinical trial.

The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Wednesday, March 23, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Aclaris Therapeutics, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: ACRS
CIK: 1557746
Form Type: 10-K Annual Report
Accession Number: 0001558370-16-004311
Submitted to the SEC: Wed Mar 23 2016 5:01:37 PM EST
Accepted by the SEC: Wed Mar 23 2016
Period: Thursday, December 31, 2015
Industry: Pharmaceutical Preparations

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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-K Annual report for the fiscal year ending Thursday, December 31, 2015

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