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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly Report for the period ending Thursday, September 30, 2021

Aclaris Therapeutics, Inc.

CIK: 1557746 Ticker: ACRS

Exhibit 99.1

Aclaris Therapeutics Reports Third Quarter 2021 Financial Results and Provides a Corporate Update

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Investigational New Drug Application for ATI-2138 for the Treatment of Psoriasis Submitted in October 2021

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Planning to Initiate Phase 2b Trial of Zunsemetinib (ATI-450) in Moderate to Severe Rheumatoid Arthritis in the Fourth Quarter of 2021

WAYNE, Pa., Nov. 02, 2021 (GLOBE NEWSWIRE) --

Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2021 and provided a corporate update.

“This quarter we are pleased to announce the submission of an investigational new drug application for ATI-2138, our investigational oral ITK/TXK/JAK3 inhibitor, the third novel clinical candidate generated by our proprietary KINect® drug discovery platform,” said Dr. Neal Walker, President & CEO of Aclaris. “If allowed, we plan to progress ATI-2138 into a Phase 1 trial. We also continue to make progress toward initiating a Phase 2b trial of zunsemetinib (ATI-450) in moderate to severe rheumatoid arthritis and Phase 2 trials of zunsemetinib in psoriatic arthritis and moderate to severe hidradenitis suppurativa, as well as our Phase 2b trial of ATI-1777 in moderate to severe atopic dermatitis.”

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

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Clinical Programs

MK2 Inhibitor Asset

o

Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor compound:

Zunsemetinib has been adopted as the nonproprietary name for ATI-450.

Aclaris plans to progress zunsemetinib into a Phase 2b trial in moderate to severe rheumatoid arthritis in the fourth quarter of 2021.

Aclaris also plans to progress zunsemetinib into Phase 2 trials in psoriatic arthritis and moderate to severe hidradenitis suppurativa.

In pre-clinical studies, positive effects on MK2 inhibition have been observed for breast cancer metastasis and cancer-associated bone loss.

“Soft” JAK Inhibitor Asset

o

ATI-1777, an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor compound:

Aclaris plans to progress ATI-1777 into a Phase 2b trial in moderate to severe atopic dermatitis in the first half of 2022. In this trial, Aclaris plans to explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777.

·

Preclinical Programs

o

ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:

Currently being developed as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease.


The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Tuesday, November 2, 2021 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 Aclaris Therapeutics, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Operations And Comprehensive Loss
Condensed Consolidated Statements Of Operations And Comprehensive Loss (Parenthetical)
Condensed Consolidated Statements Of Stockholders' Equity
Condensed Consolidated Statements Of Stockholders' Equity (Parenthetical)
Accrued Expenses
Accrued Expenses (Details)
Accrued Expenses (Tables)
Agreements Related To Intellectual Property
Agreements Related To Intellectual Property (Details)
Debt
Debt (Details)
Discontinued Operations
Discontinued Operations (Details)
Discontinued Operations (Tables)
Fair Value Of Financial Assets And Liabilities
Fair Value Of Financial Assets And Liabilities (Details)
Fair Value Of Financial Assets And Liabilities (Tables)
Fair Value Of Financial Assets And Liabilities - By Type (Details)
Income Taxes
Income Taxes (Details)
Intangible Assets
Intangible Assets (Details)
Intangible Assets (Tables)
Intangible Assets - Future Amortization Expenses (Details)
Leases
Leases (Details)
Leases (Tables)
Legal Proceedings
Legal Proceedings (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)
Property And Equipment, Net
Property And Equipment, Net (Details)
Property And Equipment, Net (Tables)
Related Party Transactions
Related Party Transactions (Details)
Segment Information
Segment Information (Details)
Segment Information (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 Event
Subsequent Event (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: 0001558370-21-013989
Submitted to the SEC: Tue Nov 02 2021 7:32:04 AM EST
Accepted by the SEC: Tue Nov 02 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations

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