Aclaris Therapeutics, Inc. (ACRS) 10-Q Quarterly Report Tue Nov 02 2021

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

Clinical Programs

MK2 Inhibitor Asset

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

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

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 - Expense Highlight
ATI-1777 The decrease in expenses for ATI-1777 during the three months ended September 30, 2021 compared to the three months ended September 30, 2020 was primarily due to lower costs associated with a Phase 2a clinical trial in subjects with moderate to severe atopic dermatitis, which concluded in the second quarter 2021.

Financial - Expense Highlight
Other research and development expenses, which primarily include expenses for our legacy dermatology assets and medical affairs activities, were lower during the nine months ended September 30, 2021 compared to September 30, 2020 due to a decrease in costs for our legacy dermatology assets following the decision to discontinue investment in those programs.
Financial - Expense Highlight
Financing Activities Financing activities use of cash was the result of: Proceeds from issuance of common stock in connection with public offerings, net of issuance costs 238,200 Proceeds from debt financing (including warrants), net of issuance costs 10,913 Repayment of debt (11,483) Restricted stock unit employee tax withholdings (3,122) Finance lease payments (128) Deferred issuance costs (242) Proceeds from exercise of employee stock options and the issuance of stock 1,459 Net cash provided by financing activities 225,054 10,543 Cash provided by financing activities increased for the nine months ended September 30, 2021 compared to September 30, 2020 primarily due to our January 2021 and June 2021 public offerings.
Financial - Expense Highlight
The following table summarizes our research and development expenses by drug candidate or, for unallocated expenses, by type: Zunsemetinib The increase in expenses for zunsemetinib during the three and nine months ended September 30, 2021 compared to the three and nine months ended September 30, 2020 was primarily due to costs associated with drug product manufacturing and clinical development activities for a Phase 2b trial in subjects with moderate to severe rheumatoid arthritis and a Phase 2 trial in subjects with moderate to severe hidradenitis suppurativa.
Financial - Expense Highlight
In addition, the Sarbanes-Oxley Act of 2002, as well as rules adopted by the SEC and the Nasdaq Stock Market LLC, requires public companies to implement specified corporate governance practices that could increase our compliance costs.
Revenue - Product
Additionally, the inclusion of estimated...Read more
Financial - Expense
The following table summarizes our...Read more
Financial - Expense
General and administrative expenses also...Read more
Financial - Shares
Equity Purchase Agreement with Lincoln...Read more
Revenue - Product
Contract research revenue was $1.4...Read more
Revenue - Product
27 Contract research revenue was...Read more
Other - Other
For example, if the FDA...Read more
Other - Other
Factors that could cause or...Read more
Other - Other
We have implemented a virtual...Read more
Other - Other
In addition, to the extent...Read more
Revenue - Product
The increase in revaluation of...Read more
Revenue - Product
The increase in revaluation of...Read more
Financial - Expense
Other expense, net primarily consists...Read more
Financial - Shares
Upon execution of the Purchase...Read more
Other - Other
We may also not be...Read more
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The change in accounts payable...Read more
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Any such changes could have...Read more
Financial - Expense
Other expense, net increased during...Read more
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29 Professional and legal fees...Read more
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The commitment shares were valued...Read more
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Positive trends in favor of...Read more
Revenue - Product
Contract research revenue is generally...Read more
M & A - Other
We initially recorded a contingent...Read more
Financial - Expense
ATI-2138 Expenses for ATI-2138 were...Read more
Financial - Expense
28 ATI-2231 Expenses for ATI-2231...Read more
Financial - Cash Flow
30 Since our inception, we...Read more
Revenue - Product
We may not be able...Read more
Other - Other
The $0.1 million increase was...Read more
Other - Other
The $0.2 million increase was...Read more
Other - Other
The increase was partially offset...Read more
Financial - Expense
Other general and administrative expenses...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

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

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

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

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