Aclaris Therapeutics, Inc. (ACRS) 10-Q Quarterly Report May 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 first quarter of 2023 and provided a corporate update.

“The first quarter of 2023 represented another period of continued progress advancing our clinical stage development programs toward important data milestones,” stated Doug Manion, M.D., Chief Executive Officer of Aclaris. “As we continue to move toward data catalysts for zunsemetinib in rheumatoid arthritis and psoriatic arthritis as well as ATI-1777 in atopic dermatitis, we also are making positive progress towards bringing our next potentially broadly applicable candidate, ATI-2138, into its first proof of concept trial in ulcerative colitis.”

Continued Dr. Manion, “Regarding our proof-of-concept trial of zunsemetinib in hidradenitis suppurativa, which we reported in March, while we did not see positive efficacy results in this particularly challenging disease, we were able to strengthen our safety database and demonstrate mechanistically that our potentially first-in-class MK2 inhibitor performed as expected.”

Research and Development Highlights:

Clinical Development Programs:

●

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 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. Based on the continued positive enrollment momentum, Aclaris is narrowing its timing guidance for topline data to the fourth quarter of 2023.

o

Psoriatic 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. Based on a slower than anticipated study start up in Europe, the trial enrollment has taken longer than expected. Based on current enrollment trends and momentum, particularly in Poland, Aclaris now expects topline data in the first half of 2024, rather than year end 2023.

●

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

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

The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Monday, May 8, 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 - 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, 2023 compared to the three months ended March 31, 2022 primarily resulted from higher sales and maturities of marketable securities during the three months ended March 31, 2023, which were used to fund our operations, partially offset from higher purchases of marketable securities during the three months ended March 31, 2023.

Legal - Other Highlight
Professional and legal fees Professional and legal fees, including accounting, investor relations and corporate communication costs, increased during the three months ended March 31, 2023 compared to the three months ended March 31, 2022 primarily as a result of an increase in patent expenses.
Other - Other Highlight
Upon execution of the agreement, we received $17.6 million from Lilly, 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 and travel expenses.
Revenue - Product Highlight
Contract research Contract research revenue was $0.9 million and $1.2 million for the three months ended March 31, 2023 and 2022, respectively, and was comprised of fees earned from the provision of laboratory services.
Financial - Cash Flow
The sources and uses of...Read more
Revenue - Geography
For example, macroeconomic events, including...Read more
Financial - Shares
Upon execution of the agreement,...Read more
Financial - Expense
In addition, the Sarbanes-Oxley Act...Read more
Financial - Expense
26 Research and Development The...Read more
Financial - Expense
ATI-2231 The decrease in expenses...Read more
Financial - Expense
ATI-1777 The increase in expenses...Read more
Other - Other
For example, if the FDA...Read more
Other - Other
Factors that could cause or...Read more
Financial - Expense
Facility and support services Facility...Read more
Other - Other
In addition, to the extent...Read more
Financial - Expense
General and Administrative The following...Read more
Other - Other
We may also not be...Read more
Financial - Expense
Licensing Licensing expenses increased during...Read more
Financial - Expense
ATI-2138 The increase in expenses...Read more
Other - Other
Any such changes could have...Read more
M & A - Other
Agreement and Plan of Merger...Read more
Revenue - Product
Contract research revenue is generally...Read more
M & A - Other
We initially recorded a contingent...Read more
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A portion of consideration received...Read more
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Since our inception, we have...Read more
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Revenue - Product
Other Other revenue was $30...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 10.4: Material Contract

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: 0001558370-23-008382
Submitted to the SEC: Mon May 08 2023 7:30:48 AM EST
Accepted by the SEC: Mon May 08 2023
Period: Friday, March 31, 2023
Industry: Pharmaceutical Preparations

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Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-Q Quarterly Report for the period ending Friday, March 31, 2023

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