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., Aug. 05, 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
  • 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.
  • 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
  • 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 (AD).  The trial consisted of a 4-week treatment period and a 2-week follow-up period during which no treatment was given.
      • As announced in June 2021, the trial achieved its primary endpoint, the percent change from baseline in the modified Eczema Area and Severity Index (mEASI) score at week 4, with a high degree of statistical significance (p