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Organization and Nature of Business
6 Months Ended
Jun. 30, 2019
Organization and Nature of Business  
Organization and Nature of Business

1. Organization and Nature of Business

 

Overview

 

Aclaris Therapeutics, Inc. was incorporated under the laws of the State of Delaware in 2012.  In July 2015, Aclaris Therapeutics International Limited (“ATIL”) was established under the laws of the United Kingdom as a wholly-owned subsidiary of Aclaris Therapeutics, Inc.  In March 2016, Vixen Pharmaceuticals, Inc. (“Vixen”) became a wholly-owned subsidiary of Aclaris Therapeutics, Inc., and in September 2018, Vixen was dissolved.  In August 2017, Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.) (“Confluence”) was acquired by Aclaris Therapeutics, Inc. and became a wholly-owned subsidiary thereof.  Aclaris Therapeutics, Inc., ATIL, Vixen and Confluence are referred to collectively as the “Company.”  The Company is a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases. The Company currently has two commercial products and a diverse pipeline of drug candidates.    RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”) was approved by the U.S. Food and Drug Administration (“FDA”) in January 2017 for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults.  The Company’s other commercial product, ESKATA (hydrogen peroxide) topical solution, 40% (w/w) (“ESKATA”), is a proprietary formulation of high-concentration hydrogen peroxide which was approved by the FDA in December 2017 as an office-based prescription treatment for raised seborrheic keratosis (“SK”), a common non-malignant skin tumor. The Company launched ESKATA in the United States in May 2018.  In August 2019, the Company voluntarily discontinued the commercialization of ESKATA in the United States. The Company continues to maintain the New Drug Application (“NDA”) for ESKATA in the United States. The Company is currently seeking a strategic partner to commercialize ESKATA, both in the United States and worldwide (excluding Canada).

 

Liquidity

 

The Company’s condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. At June 30, 2019, the Company had cash, cash equivalents and marketable securities of $115,517 and an accumulated deficit of $379,614.  Since inception, the Company has incurred net losses and negative cash flows from its operations.  Prior to the acquisition of Confluence in August 2017, the Company had never generated any revenue.  There can be no assurance that profitable operations will ever be achieved, and, if achieved, will be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing of the Company’s drug candidates, and commercialization of the Company’s marketed product(s) will require significant additional financing.  The future viability of the Company is dependent on its ability to generate cash from operating activities or to raise additional capital to finance its operations.  The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.