Please wait while we load the requested 10-Q report or click the link below:
https://last10k.com/sec-filings/report/1557746/000155837022016738/acrs-20220930x10q.htm
November 2023
November 2023
September 2023
August 2023
June 2023
June 2023
June 2023
May 2023
April 2023
March 2023
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:
● | Zunsemetinib, an investigational oral small molecule MK2 inhibitor: |
Currently being developed as a potential treatment for immuno-inflammatory diseases
o | Hidradenitis 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. |
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. Aclaris expects topline data in the second half of 2023. |
Please wait while we load the requested 10-Q report or click the link below:
https://last10k.com/sec-filings/report/1557746/000155837022016738/acrs-20220930x10q.htm
Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Aclaris Therapeutics, Inc..
Aclaris Therapeutics, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:
Rating
Learn More![]()
33 Investing Activities Cash flow related to investing activities was the result of: Net cash provided by investing activities for the nine months ended September 30, 2022 compared to net cash used in investing activities for the nine months ended September 30, 2021 primarily resulted from higher sales and maturities of marketable securities during the nine months ended September 30, 2022, which were used to fund our operations, and a reduction of purchases of marketable securities, which were higher during the nine months ended September 30, 2021 following our January 2021 and June 2021 public offerings.
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.
Personnel and stock-based compensation Personnel and stock-based compensation expenses increased in the aggregate during the three and nine months ended September 30, 2022 compared to the three and nine months ended September 30, 2021 primarily due to an increase in costs associated with higher average headcount.
Research and Development 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, 2022 compared to the three and nine months ended September 30, 2021 was primarily due to costs associated with clinical development activities for a Phase 2b trial in subjects with rheumatoid arthritis, which initiated in December 2021, a Phase 2a trial in subjects with hidradenitis suppurativa, which initiated in December 2021, a Phase 2a trial in subjects with psoriatic arthritis, which initiated in June 2022, and several ancillary clinical trials.
Facility and support services Facility and support services, including general office expenses, information technology costs and other expenses, increased during the three and nine months ended September 30, 2022 compared to the three and nine months ended September 30, 2021 primarily due to an increase in overhead expenses, including increases in tax and license fees and information technology support costs.
Contract research Contract research revenue...Read more
In addition, the Sarbanes-Oxley Act...Read more
Financing Activities Cash flow related...Read more
Additionally, the inclusion of estimated...Read more
Additionally, the inclusion of estimated...Read more
ATI-1777 The increase in expenses...Read more
28 Contract research revenue was...Read more
For example, if the FDA...Read more
Factors that could cause or...Read more
Sale of Common Stock under...Read more
30 Professional and legal fees...Read more
In addition, to the extent...Read more
General and Administrative The following...Read more
During the three months ended...Read more
Other income (expense), net primarily...Read more
We may also not be...Read more
Any such changes could have...Read more
We recorded increases during the...Read more
We recorded increases during the...Read more
ATI-2138 demonstrated linear pharmacokinetic data...Read more
Agreement and Plan of Merger...Read more
Positive trends in favor of...Read more
We have implemented a hybrid...Read more
Contract research revenue is generally...Read more
The decrease in the fair...Read more
We initially recorded a contingent...Read more
Since our inception, we have...Read more
We may not be able...Read more
Our primary uses of capital...Read more
We also had $186.4 million...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
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