Aclaris Therapeutics, Inc. (ACRS) 10-Q Quarterly Report August 2023

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 second quarter of 2023 and provided a corporate update.

“During the second quarter of this year, we continued to make positive strides across our clinical development pipeline, most notably through the completion of enrollment in our Phase 2b trial of zunsemetinib in patients with rheumatoid arthritis, which positions that trial to be our next Phase 2 data read-out,” stated Doug Manion, M.D., Chief Executive Officer of Aclaris. “The next several quarters are lining up well with data read-outs for each of our clinical stage development therapeutics, all created by our KINect® drug discovery platform.”

Research and Development Highlights:

●

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:

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

o

Rheumatoid Arthritis (ATI-450-RA-202): This Phase 2b placebo-controlled 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) completed enrollment in June 2023. Aclaris continues to expect topline data in the fourth quarter of 2023.

o

Psoriatic Arthritis (ATI-450-PsA-201): This Phase 2a placebo-controlled 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 continues to expect topline data in the first half of 2024.

●

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

Currently being developed as a potential treatment for mild to severe atopic dermatitis (AD)

o

Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b vehicle-controlled trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with mild to severe AD is ongoing. Aclaris continues to expect topline data in the second half of 2023.

The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Monday, August 7, 2023 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 and six months ended June 30, 2023 compared to the three and six months ended June 30, 2022 was primarily due to lower costs associated with drug candidate manufacturing and other preclinical development activities.

Other - Other Highlight
Upon execution of the agreement, we received $17.6 million, a portion of which represented payments for regulatory and commercial milestones that were deemed to have been achieved as of the execution of the license agreement.
Financial - Expense Highlight
General and administrative expenses also include facility-related costs, patent filing and prosecution costs, professional fees for legal, auditing and tax services, investor relations costs, business development costs, insurance costs, travel expenses and bad debt expense.
Revenue - Product Highlight
26 Contract research Contract research revenue was $0.9 million and $1.2 million for the three months ended June 30, 2023 and 2022, respectively, and was comprised of fees earned from the provision of laboratory services.
Revenue - Geography Highlight
For example, macroeconomic events, including rising inflation, the U.S. Federal Reserve raising interest rates, the closure of financial institutions and the Russia-Ukraine war, have led to economic uncertainty globally.
Financial - Shares
23 Upon execution of the...Read more
Financial - Expense
In addition, the Sarbanes-Oxley Act...Read more
Financial - Expense
Research and Development The following...Read more
Financial - Expense
28 ATI-2231 The decrease in...Read more
Revenue - Product
Contract research revenue was $1.8...Read more
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The sources and uses of...Read more
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Professional and legal fees Professional...Read more
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For example, if the FDA...Read more
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This increase was partially offset...Read more
Other - Other
Factors that could cause or...Read more
Financial - Expense
General and Administrative The following...Read more
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In addition, to the extent...Read more
Financial - Shares
In April 2022, we sold...Read more
Other - Other
We may also not be...Read more
Financial - Expense
ATI-2138 The increase in expenses...Read more
Other - Other
Any such changes could have...Read more
M & A - Other
33 Agreement and Plan of...Read more
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Revaluation of Contingent Consideration The...Read more
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Contract research revenue is generally...Read more
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We initially recorded a contingent...Read more
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Since our inception, we have...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 3.2: Articles Of Incorporation

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: 0001558370-23-013491
Submitted to the SEC: Mon Aug 07 2023 7:30:46 AM EST
Accepted by the SEC: Mon Aug 07 2023
Period: Friday, June 30, 2023
Industry: Pharmaceutical Preparations

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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly Report for the period ending Friday, June 30, 2023

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