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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly report for the period ending Sunday, March 31, 2019

Aclaris Therapeutics, Inc.

CIK: 1557746 Ticker: ACRS

Exhibit 99.1

Aclaris Therapeutics Reports First Quarter 2019 Financial Results and Provides Update on Clinical and Commercial Developments

 

 

 

 

 

  

Submitted IND for ATI-450, an oral MK2 inhibitor

 

 

  

RHOFADE net sales of $3.7 million for the first quarter of 2019

 

 

  

Management to Host Conference Call at 5:00 PM ET today

 

 

Wayne, PA – May 8, 2019 (GLOBE NEWSWIRE) – 

Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced its financial results for the first quarter of 2019, and provided an update on its clinical development and commercial programs.

 

Highlights:

·

Aclaris submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-450, an oral MK2 inhibitor, for the treatment of rheumatoid arthritis (RA) in April 2019.  It would be Aclaris’ first internally-developed novel compound to enter the clinical phase of development and its first inflammatory indication adjacent to dermatology. Aclaris expects to begin a Phase 1 clinical trial of ATI-450, an investigational compound, in the second half of 2019.

·

In April 2019, Aclaris completed enrollment of more than 1,000 patients across two Phase 3 pivotal clinical trials (THWART-1 and THWART-2) investigating A-101 45% Topical Solution, an investigational drug, for the treatment of common warts, and expects to complete enrollment of Aclaris’ open-label safety extension trial (WART-303) evaluating the long-term safety of A-101 45% Topical Solution during the second quarter of 2019.

·

During the first quarter of 2019, total net revenues were $5.0 million, which included net sales of RHOFADE® (oxymetazoline hydrochloride) cream, 1% of $3.7 million, building on the positive momentum from December 2018.

·

In April 2019, the United States Patent and Trademark Office issued U.S. Patent No. 10,265,258 covering methods of treating alopecia areata (AA) using ruxolitinib or isotopic forms of ruxolitinib.  The claims in this issued patent cover the use of an effective amount of isotopic forms of ruxolitinib, such as deuterated ruxolitinib, to treat AA. This patent is exclusively licensed to Aclaris.  This represents the continued expansion of the IP estate with numerous claims directed against ruxolitinib, baricitinib, tofacitinib and decernotinib.


The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Wednesday, May 8, 2019 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
Accrued Expenses
Accrued Expenses (Details)
Accrued Expenses (Tables)
Agreements Related To Intellectual Property
Agreements Related To Intellectual Property (Details)
Debt
Debt (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 - Rate Reconciliation (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 Cost (Details)
Leases - Supplemental Information Related To Operating And Finance Leases (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)
Stockholders' Equity - Other Offerings (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Details)
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Goodwill (Details)
Summary Of Significant Accounting Policies - Product Sales (Details)
Summary Of Significant Accounting Policies - Recent Pronouncements (Details)
Summary Of Significant Accounting Policies - Risk (Details)

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: 0001558370-19-004494
Submitted to the SEC: Wed May 08 2019 1:01:37 PM EST
Accepted by the SEC: Wed May 08 2019
Period: Sunday, March 31, 2019
Industry: Pharmaceutical Preparations

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