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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-K Annual report for the fiscal year ending Thursday, December 31, 2020

Aclaris Therapeutics, Inc.

CIK: 1557746 Ticker: ACRS

Exhibit 99.1

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides a Corporate Update

 

Positive Preliminary Topline Data for ATI-450, an Investigational Oral MK2 Inhibitor, in Moderate to Severe Rheumatoid Arthritis Announced in January 2021

ATI-450 Data Support New Oral Approach for the Potential Treatment of Immuno-inflammatory Diseases, such as Rheumatoid Arthritis

  

Public Offering of $103.5M in January 2021 Strengthens Balance Sheet

WAYNE, Pa., February 25, 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 fourth quarter and full year of 2020 and provided a corporate update.

“As we reflect on 2020, we are proud of how we have progressed our immuno-inflammatory development programs,” said Dr. Neal Walker, President & CEO of Aclaris. “We are very excited about the platform potential of ATI-450, an oral MK2 inhibitor which we have shown to inhibit TNFα, IL1β, and IL6. Given its novel mechanism, there are several immuno-inflammatory indications that ATI-450 may potentially address. We are also excited about the potential of our pipeline which is internally generated from KINect®, our proprietary drug discovery platform, for various immuno-inflammatory indications. We look forward to building on this momentum in 2021.”

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.

ATI-450, an investigational oral small molecule MK2 inhibitor compound:
oATI-450-RA-201: A Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
Positive preliminary topline data announced in January 2021. In this trial, ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and improvement of ACR20/50/70 responses over 12 weeks. This clinical activity was further supported by pharmacodynamic analyses showing a marked and durable inhibition of TNFα, IL1β, IL6, and IL8 in ex vivo stimulated samples as well as an endogenous inflammation biomarker analysis which also demonstrated a marked and sustained inhibition of median concentrations of hsCRP, TNFα, IL6, IL8, and MIP1β in the treatment arm over the 12 week period.
ATI-450 was generally well tolerated. The most common adverse events (AE) (each reported in 2 subjects) were urinary tract infection (UTI), elevated lipids and ventricular extrasystoles, all of which were determined to be unrelated to treatment except for one UTI. There was one non-treatment-related serious adverse event (COVID-19) reported in

The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Thursday, February 25, 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-K Annual 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-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations And Comprehensive Loss
Consolidated Statements Of Operations And Comprehensive Loss (Parenthetical)
Consolidated Statements Of Stockholders' Equity
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)
Discontinued Operations - Assets And Liabilities (Details)
Discontinued Operations - Cash Flow (Details)
Discontinued Operations - Loss (Details)
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 (Tables)
Income Taxes - Deferred Assets And Liabilities, Cfds (Details)
Income Taxes - Rate Reconciliation (Details)
Income Taxes - Valuation Allowance And Unrecognized Tax Benefits (Details)
Intangible Assets
Intangible Assets (Details)
Intangible Assets (Tables)
Intangible Assets - Future Amortization Expenses (Details)
Leases
Leases (Details)
Leases (Tables)
Leases - Finance Leases (Details)
Leases - Future Maturities Of Lease Liabilities (Details)
Leases - Lease Costs (Details)
Leases - Supplemental Information Related To Operating And Finance Leases (Details)
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)
Restructuring Charges
Restructuring Charges (Details)
Retirement Savings Plan
Retirement Savings Plan (Details)
Rhofade
Rhofade (Tables)
Rhofade - Amount Paid For Assets Acquired (Details)
Rhofade - Summary Of Fair Value Assets Acquired (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)
Stockholders' Equity - Other Offerings (Details)
Subsequent Events
Subsequent Events (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Details)
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies - Goodwill (Details)
Summary Of Significant Accounting Policies - Intangible Assets (Details)
Summary Of Significant Accounting Policies - Property And Equipment (Details)
Summary Of Significant Accounting Policies - Recent Pronouncements (Details)
Summary Of Significant Accounting Policies - Segments (Details)
Summary Of Significant Accounting Policies - Stock-Based Compensation And Concentration Of Credit Risk And Of Significant Suppliers (Details)
Ticker: ACRS
CIK: 1557746
Form Type: 10-K Annual Report
Accession Number: 0001558370-21-001717
Submitted to the SEC: Thu Feb 25 2021 7:33:05 AM EST
Accepted by the SEC: Thu Feb 25 2021
Period: Thursday, December 31, 2020
Industry: Pharmaceutical Preparations

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