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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly report for the period ending Friday, March 31, 2017

Aclaris Therapeutics, Inc.

CIK: 1557746 Ticker: ACRS

Exhibit 99.1

Aclaris New Logo

 

Aclaris Therapeutics Reports First Quarter 2017 Financial Results 

Management to Host Conference Call at 4:30 PM ET today

 

 

Malvern, PA – May 9, 2017 (GLOBE NEWSWIRE) –

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

“The start of 2017 has been a busy one for Aclaris and we are pleased the momentum from last year has continued into the first quarter of this year,” commented Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “Our New Drug Application (NDA) for A-101 40% Topical Solution (A-101 40%) for the treatment of seborrheic keratosis (SK) was accepted for review by the U.S. Food and Drug Administration (FDA). We continue to advance our pipeline and broaden our intellectual property estate as we focus our efforts on developing innovative treatments for patients.”

 

Clinical Pipeline Update

·

A-101 40% Topical Solution

o

The NDA for A-101 40% for the topical treatment of SK has been accepted by the FDA for review.

o

The NDA contains data from three Phase 3 trials that included more than 1,000 patients.

o

Plan to submit a marketing authorization application (MAA) for A-101 40% for the treatment of SK in the European Union in the second half of 2017.

 

·

A-101 45% Topical Solution

o

Plan to initiate two Phase 2 clinical trials of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts in mid-2017.

·

JAK Inhibitor

o

Recently completed a Phase 1 clinical trial of ATI-50001, an investigational oral Janus Kinase (JAK) 1/3 inhibitor. This Phase 1 cross-over trial was conducted in 12 healthy volunteers at one investigational center in the United States to assess safety, bioavailability, and pharmacodynamics.

o

In the Phase 1 trial, treatment with ATI-50001 capsules was well tolerated. No clinically significant laboratory abnormalities were observed. These data are consistent with results from an earlier Phase 1 clinical trial in 44 healthy volunteers conducted by Rigel Pharmaceuticals in which the study drug was well tolerated at all doses.

§

Plan to initiate a Phase 2 dose ranging trial with ATI-50001 for the oral treatment of alopecia totalis and alopecia universalis in the second half of 2017.

o

In addition, Aclaris also plans to develop an investigational topical JAK 1/3 inhibitor, known as ATI-50002, for the treatment of AA and vitiligo.

§

Plan to submit an Investigational New Drug application (IND) for ATI-50002 for the topical treatment of patchy AA in mid-2017.

1

 


The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Tuesday, May 9, 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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Inside this 10-Q Quarterly Report

Document And Entity Information
Consolidated Balance Sheets (parenthetical)
Consolidated Statement Of Stockholders' Equity
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations And Comprehensive Loss
Consolidated Statements Of Operations And Comprehensive Loss (parenthetical)
Consoliidated Balance Sheets
Accrued Expenses
Accrued Expenses (details)
Accrued Expenses (tables)
Agreements Related To Intellectual Property
Agreements Related To Intellectual Property (details)
Commitments And Contingencies
Commitments And Contingencies (details)
Commitments And Contingencies (tables)
Fair Value Of Financial Assets And Liabilities
Fair Value Of Financial Assets And Liabilities (detail)
Fair Value Of Financial Assets And Liabilities (tables)
Fair Value Of Financial Assets And Liabilities - By Type (details)
Income Taxes
Income Taxes (details)
Net Loss Per Share
Net Loss Per Share (details)
Net Loss Per Share (tables)
Net Loss Per Share - Anti-dilution (details)
Organization And Nature Of Business
Organization And Nature Of Business (details)
Organization And Nature Of Business - Ipo, Stock Split, Liquidity (details)
Property And Equipment, Net
Property And Equipment, Net (details)
Property And Equipment, Net (tables)
Related Party Transactions
Related Party Transactions (details)
Related Party Transactions (tables)
Stock-based Awards
Stock-based Awards (details)
Stock-based Awards (tables)
Stock-based Awards - Compensation (details)
Stock-based Awards - Option Activity (details)
Stock-based Awards - Rsus (details)
Stockholders' Equity
Stockholders' Equity (details)
Subsequent Events
Subsequent Events (details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (details)
Summary Of Significant Accounting Policies (policies)

Material Contracts, Statements, Certifications & more

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

Ticker: ACRS
CIK: 1557746
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-17-004000
Submitted to the SEC: Tue May 09 2017 4:31:17 PM EST
Accepted by the SEC: Tue May 09 2017
Period: Friday, March 31, 2017
Industry: Pharmaceutical Preparations

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