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Organization and Nature of Business
9 Months Ended
Sep. 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 diseases. The Company currently has one commercial product and a diverse pipeline of drug candidates, including one late-stage investigational drug candidate.  In October 2019, the Company sold the worldwide rights to one of its commercial products, RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”), which includes the assignment of certain licenses for related intellectual property assets (see Note 19).    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 U.S. Food and Drug Administration (“FDA”) as an office-based prescription treatment for raised seborrheic keratosis (“SK”), a common non-malignant skin tumor. In August 2019, the Company voluntarily discontinued the commercialization of ESKATA in the United States and withdrew the marketing authorizations it had previously received for the product in all countries outside of 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 worldwide.

 

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 September 30, 2019, the Company had cash, cash equivalents and marketable securities of $91,428 and an accumulated deficit of $434,933.   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, research and development activities, including preclinical and clinical testing of the Company’s drug candidates will require significant additional financing.  The future viability of the Company is dependent on its ability to successfully develop its drug candidates and generate revenue from identifying and consummating transactions with potential third-party partners to further develop, obtain marketing approval for and/or commercialize its development assets 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.