Aclaris Therapeutics, Inc. (ACRS) 10-Q Quarterly Report May 2022

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 2021 and provided a corporate update.

“2021 was a tremendous year for the progression of our drug development pipeline, and I’m very proud of what our team has accomplished,” said Dr. Neal Walker, President & CEO of Aclaris. “We reported positive data for our Phase 2a trials of zunsemetinib in subjects with moderate to severe rheumatoid arthritis (RA) and ATI-1777 in subjects with moderate to severe atopic dermatitis (AD), and strengthened our balance sheet to continue this momentum in 2022. Moving forward, we are progressing zunsemetinib in three immuno-inflammatory indications, moving ATI-1777 forward in moderate to severe AD, and progressing ATI-2138 in SAD/MAD studies. Our KINect® drug discovery platform continues to be productive and we now have three clinical-stage compounds as well as an early-stage immuno-inflammatory and oncology pipeline. We have the privilege of working toward the goal of helping address the needs of patients with immuno-inflammatory diseases as well as cancer and look forward to progressing our assets to achieve this goal.”

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

●

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:

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

o

ATI-450-RA-202: This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe RA is ongoing.

◾

Aclaris anticipates increasing the size of the patient population from approximately 195 to approximately 240 subjects and expects topline data in 2023.

o

ATI-450-HS-201: This Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice daily) in subjects with moderate to severe HS is ongoing.

◾

Aclaris expects topline data in the first half of 2023.

o

ATI-450-PsA-201: Aclaris plans to progress zunsemetinib (50 mg twice daily) into a Phase 2a trial in subjects with moderate to severe psoriatic arthritis in the first half of 2022.

●

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

Currently being developing as a potential treatment for moderate to severe AD

The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Thursday, February 24, 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 - Cash Flow Highlight
Investing Activities Cash flow related to investing activities was the result of: The change in net cash provided by investing activities for the three months ended March 31, 2022 compared to net cash used in investing activities for the three months ended March 31, 2021 primarily resulted from sales and maturities of marketable securities during the three months ended March 31, 2022 which were used to fund company operations and a reduction of purchases of marketable securities which were higher during the three months ended March 31, 2021 following our January 2021 public offering.

Legal - Other Highlight
Professional and legal fees Professional and legal fees, including accounting, investor relations and corporate communication costs, were lower during the three months ended March 31, 2022 compared to the three months ended March 31, 2021 primarily as a result of lower legal fees partially offset by higher Sarbanes-Oxley and other accounting compliance expenses.
Financial - Expense Highlight
The following table summarizes our research and development expenses by drug candidate or, for unallocated expenses, by type: 27 Zunsemetinib The increase in expenses for zunsemetinib during the three months ended March 31, 2022 compared to the three months ended March 31, 2021 was primarily due to costs associated with clinical development activities for a Phase 2b trial in subjects with rheumatoid arthritis and a Phase 2a trial in subjects with hidradenitis suppurativa which were initiated in December 2021.
Financial - Expense Highlight
The following table summarizes our general and administrative expenses: 28 Personnel and stock-based compensation Personnel and stock-based compensation expenses increased during the three months ended March 31, 2022 compared to the three months ended March 31, 2021 primarily due to an increase in costs associated with higher average headcount and an increase in stock-based compensation expense associated with new equity awards granted in 2022.
Financial - Expense Highlight
Facility and support services Facility and support services, including general office expenses, information technology costs and other expenses, increased during the three months ended March 31, 2022 compared to the three months ended March 31, 2021 primarily due to an increase in overhead expenses including increases in tax and license fees and information technology support costs.
Financial - Expense
In addition, the Sarbanes-Oxley Act...Read more
Financial - Expense
General and administrative expenses also...Read more
Financial - Expense
ATI-1777 The increase in expenses...Read more
Revenue - Product
26 Contract research revenue was...Read more
Other - Other
For example, if the FDA...Read more
Other - Other
Factors that could cause or...Read more
Financial - Shares
At-the-Market Offering In April 2022,...Read more
Revenue - Product
Sales of Common Stock Pursuant...Read more
Other - Other
We have implemented a virtual...Read more
Other - Other
In addition, to the extent...Read more
Other - Other
We may also not be...Read more
Other - Other
Any such changes could have...Read more
Financial - Expense
Clinical development expenses associated with...Read more
Other - Other
Positive trends in favor of...Read more
Financial - Expense
ATI-2138 Expenses for ATI-2138 were...Read more
Financial - Income
Other income (expense), net primarily...Read more
Revenue - Product
Contract research revenue is generally...Read more
M & A - Other
We initially recorded a contingent...Read more
Financial - Expense
ATI-2231 Expenses for ATI-2231 were...Read more
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Since our inception, we have...Read more
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We may not be able...Read more
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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: 0001558370-22-007972
Submitted to the SEC: Tue May 10 2022 7:30:42 AM EST
Accepted by the SEC: Tue May 10 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations

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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

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