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Aclaris Therapeutics, Inc. (NASDAQ: ACRS) is a leading clinical-stage biopharmaceutical company specializing in the development of innovative therapies for immuno-inflammatory diseases. Founded by dermatologists, Aclaris leverages its extensive expertise in dermatologic treatments to address significant unmet needs in both medical and aesthetic dermatology.
Aclaris operates primarily through two segments: therapeutics and contract research. The therapeutics segment focuses on identifying and developing novel therapies to treat immuno-inflammatory diseases. Key drug candidates in this segment include Zunsemetinib, an oral MK2 inhibitor, ATI-2138, an ITJ inhibitor, and ATI-1777, a topical JAK 1/3 inhibitor. The contract research segment generates revenue by offering laboratory services, which constitute a significant portion of the company’s revenue.
Recent milestones for Aclaris include the progression of ATI-2138 into Phase 2a proof-of-concept trials for T cell-mediated autoimmune diseases and the completion of enrollment for the ATI-1777 Phase 2b trial in atopic dermatitis. Preliminary data from these trials have shown promising results, paving the way for further clinical development. Aclaris has also announced partnerships with institutions like Washington University to explore additional therapeutic applications for its drug candidates.
Financially, Aclaris maintains a robust liquidity position. As of the end of 2023, the company holds approximately $181.9 million in cash, cash equivalents, and marketable securities, ensuring the capability to fund operations through 2025. Revenue generation is primarily driven by contract research services and strategic licensing agreements, such as the recent deal with Sun Pharmaceutical Industries, Inc., which grants exclusive rights under certain patents for the use of deuruxolitinib in treating alopecia areata and androgenetic alopecia.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced its participation in the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 30, 2023, at 1:00 PM ET. Members of the management team will engage in a fireside chat, which can be accessed via the 'Events' page on Aclaris' website. The webcast will be archived for at least 30 days. Aclaris focuses on developing novel drug candidates for patients with immuno-inflammatory diseases and boasts a multi-stage portfolio powered by a strong R&D engine, addressing significant treatment gaps in this area.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced preliminary topline results from its Phase 2a study evaluating zunsemetinib for treating moderate to severe hidradenitis suppurativa (HS). The study, involving 95 patients across 19 sites, did not meet its primary endpoint of reduced inflammatory nodule/abscess count compared to placebo. Secondary efficacy endpoints were also unmet. Although zunsemetinib's safety profile was consistent with prior studies, notable treatment-emergent adverse events included dizziness (16.7%) and diarrhea (12.5%). Aclaris remains optimistic about zunsemetinib's mechanism of action and is looking forward to upcoming data from its Phase 2b rheumatoid arthritis study.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) reported its financial results for Q4 and the full year of 2022, highlighting a net loss of $27.6 million for Q4, up from $22.8 million in Q4 2021. Total revenue rose to $7.8 million in Q4, driven by $6.7 million in licensing revenue. For the full year, Aclaris recorded a net loss of $86.9 million, an improvement from $90.9 million in 2021. Revenue increased to $29.8 million, mainly due to licensing agreements, including $17.6 million from Eli Lilly. The company has $229.8 million in cash and equivalents, expected to fund operations through 2025. Upcoming milestones include topline data from clinical trials for zunsemetinib in hidradenitis suppurativa in March 2023.
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