Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly report for the period ending Friday, June 30, 2017

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Aclaris Therapeutics, Inc.
Ticker: ACRS CIK: 1557746

Aclaris Therapeutics Reports Second Quarter 2017 Financial Results

Management to Host Conference Call at 8:30 AM ET today

Malvern, PA – August 8, 2017 (GLOBE NEWSWIRE) –

Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a dermatologist-led biopharmaceutical company, today announced financial results for the second quarter of 2017 and provided an update on its clinical development programs.

“The second quarter of 2017 has been a busy one for Aclaris and today we are pleased to announce we have acquired Confluence Life Sciences,” commented Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “This acquisition is an important step in Aclaris becoming a fully integrated biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology.”

Clinical Pipeline Update

A-101 40% Topical Solution

Earlier this month, submitted a Marketing Authorization Application (MAA) for A-101 40% Topical Solution (A-101 40%) for the treatment of seborrheic keratosis (SK) with the Medicines Product Agency (MPA) in Sweden. The MPA will act as the reference member state in this decentralized procedure for review of the MAA for potential marketing approval throughout Europe. If approved, A-101 40% would be available to be commercialized in 16 countries in the European Union.

A-101 45% Topical Solution

In June, initiated two Phase 2 clinical trials of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts. The Phase 2b clinical trials are designed to evaluate the safety, tolerability and dose frequency of A-101 45% compared with its vehicle (placebo). Approximately 240 patients are expected to be randomized in the two double-blinded trials, which are being conducted at 30 investigational centers within the United States.

JAK Inhibitors

Continue plans to initiate a Phase 2 dose ranging trial of ATI-50001, an oral Janus kinase (JAK) inhibitor, for the treatment of alopecia totalis and alopecia universalis in the second half of 2017.

Earlier this month, submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for another JAK inhibitor, ATI-50002, for the treatment of patchy alopecia areata (AA). Following FDA clearance of the IND, Aclaris expects to initiate two Phase 2 clinical trials of ATI-50002, a topical Janus Kinase (JAK) 1/3 inhibitor in the second half of 2017. These trials will be conducted at multiple investigational centers across the United States.

Continue plans to initiate a Phase 2 trial of ATI-50002 for the topical treatment of vitiligo in the second half of 2017.

Continue to develop another series of topical JAK inhibitors for the treatment of androgenetic alopecia (AGA).

The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Tuesday, August 8, 2017 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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