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Exhibit 99.1
Aclaris Therapeutics Reports Second Quarter 2021 Financial Results and Provides a Corporate Update
| ● | Public Offering with Net Proceeds of $134.9 Million in June Strengthens Balance Sheet and Extends Cash Runway Through the End of 2024 | | |
| ● | Positive Preliminary Topline Data for Phase 2a Trial of ATI-1777 in Moderate to Severe Atopic Dermatitis Announced in June | | |
| ● | Advancing ATI-450 with Planned Initiation of Phase 2b Trial for Moderate to Severe Rheumatoid Arthritis in Fourth Quarter of 2021 | |
WAYNE, Pa., August 5, 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 second quarter of 2021 and provided a corporate update.
“We’re very pleased with the preliminary topline data from our Phase 2a trial of our “soft” topical JAK1/3 inhibitor, ATI-1777, that we announced during the quarter,” said Dr. Neal Walker, President & CEO of Aclaris. “Our recent clinical trial successes with ATI-450 and ATI-1777 demonstrate the value and productivity of our proprietary KINect® drug discovery platform. With our financing in June, we are well positioned to advance our clinical trial programs for ATI-450 and ATI-1777 and develop compounds from our early stage pipeline.”
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.
● | MK2 Inhibitor Assets |
o | ATI-450, an investigational oral small molecule MK2 inhibitor compound: |
◾ | Aclaris plans to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the fourth quarter of 2021. |
◾ | Aclaris also plans to progress ATI-450 into Phase 2 trials in hidradenitis suppurativa and psoriatic arthritis. |
◾ | In pre-clinical studies, positive effects on MK2 inhibition have been observed for breast cancer metastasis and cancer-associated bone loss. |
o | ATI-2231, an investigational oral MK2 inhibitor compound: |
◾ | Second MK2 inhibitor generated from Aclaris’ proprietary KINect® drug discovery platform and designed to have a long half-life. |
◾ | Currently being explored as a potential treatment for metastatic breast cancer and pancreatic cancer as well as use in preventing bone loss in this patient population. |
◾ | IND-enabling studies are underway. |
● | “Soft” JAK Inhibitor Asset |
o | ATI-1777, an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor compound: |
◾ | ATI-1777-AD-201: A Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to evaluate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in 50 subjects with moderate to severe atopic dermatitis |
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Facility and support services, including general office expenses, information technology costs and other expenses, decreased during the three and six months ended June 30, 2021 compared to the three and six months ended June 30, 2020 primarily due to lower information technology costs resulting from lower headcount.
ATI-1777 The decrease in expenses for ATI-1777 during the three months ended June 30, 2021 compared to the three months ended June 30, 2020 was primarily due to lower costs associated with a Phase 2a clinical trial in subjects with moderate to severe atopic dermatitis as well as other development costs.
Other research and development expenses, which primarily include expenses for our legacy dermatology assets and medical affairs activities, were lower during the three and six months ended June 30, 2021 compared to June 30, 2020 due to a decrease in costs for our legacy dermatology assets following the decision to discontinue investment in those programs.
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 Restricted stock unit employee tax withholdings (3,038) Finance lease payments (92) Proceeds from exercise of employee stock options and the issuance of stock 1,459 Net cash provided by financing activities 236,621 10,821 Cash provided by financing activities increased for the six months ended June 30, 2021 compared to June 30, 2020 primarily due to our January 2021 and June 2021 public offerings.
28 The following table summarizes our research and development expenses by drug candidate or, for unallocated expenses, by type: ATI-450 The increase in expenses for ATI-450 during the three months ended June 30, 2021 compared to the three months ended June 30, 2020 was primarily due to additional costs associated with multiple clinical trials, including preparation activities for a Phase 2b trial in subjects with moderate to severe rheumatoid arthritis.
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ATI-2138 Expenses for ATI-2138 were...Read more
30 Since our inception, we...Read more
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29 Personnel and stock-based compensation...Read more
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Financial Statements, Disclosures and Schedules
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Aclaris Therapeutics, Inc. provided additional information to their SEC Filing as exhibits
Ticker: ACRS
CIK: 1557746
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-21-010389
Submitted to the SEC: Thu Aug 05 2021 7:31:25 AM EST
Accepted by the SEC: Thu Aug 05 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations