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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly Report for the period ending Friday, September 30, 2022

Aclaris Therapeutics, Inc.

CIK: 1557746 Ticker: ACRS

Exhibit 99.1

Aclaris Therapeutics Reports Third Quarter 2022 Financial Results and Provides a Corporate Update

- Completed Enrollment in Phase 2a Trial of Zunsemetinib in Hidradenitis Suppurativa; Topline Data Expected in Mid-first Half of 2023

- Announced Patent License Agreement with Lilly for the Treatment of Alopecia Areata with Proceeds of $17.6 million

- Successfully Completed ATI-2138 Phase 1 SAD (single ascending dose) Trial in November; Selected Ulcerative Colitis as First Clinical Development Target

WAYNE, Pa., Nov. 08, 2022 (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 2022 and provided a corporate update.

“The third quarter of this year marked another period of important milestone achievement - the successful completion of enrollment in the Phase 2a trial of zunsemetinib in hidradenitis suppurativa,” said Dr. Neal Walker, Chief Executive Officer of Aclaris. “We also recently successfully completed the Phase 1 SAD trial for ATI-2138. We are very pleased with the results from the Phase 1 SAD trial which we believe support us proceeding to a multiple ascending dose (MAD) trial. Additionally, we have selected ulcerative colitis as the first target indication for ATI-2138 given the compelling pre-clinical profile and high medical need that persists for this debilitating disease.

Research and Development Highlights:

Clinical Programs

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:

Currently being developed as a potential treatment for immuno-inflammatory diseases

oRheumatoid Arthritis (ATI-450-RA-202): This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing. Aclaris expects topline data in the second half of 2023.

oHidradenitis Suppurativa (ATI-450-HS-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) over 12 weeks in subjects with moderate to severe hidradenitis suppurativa (HS) has completed enrollment with 95 patients randomized and is ongoing. Aclaris expects topline data in mid-first half of 2023.

oPsoriatic Arthritis (ATI-450-PsA-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis (PsA) is ongoing. Aclaris expects topline data in the second half of 2023.


The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Tuesday, November 8, 2022 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 (Tables)
Discontinued Operations - Assets And Liabilities (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 (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)
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 And Atm Facility (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: 0001558370-22-016738
Submitted to the SEC: Tue Nov 08 2022 7:30:38 AM EST
Accepted by the SEC: Tue Nov 08 2022
Period: Friday, September 30, 2022
Industry: Pharmaceutical Preparations

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