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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 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.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a biopharmaceutical company, will participate in a fireside chat during the Virtual SVB Securities Global Biopharma Conference on February 14, 2023, at 9:20 AM ET. The event can be accessed via a webcast on the company’s website, where it will be archived for 30 days. Aclaris focuses on developing innovative drug candidates for immuno-inflammatory diseases, aiming to meet the needs of patients with limited treatment options. The company features a strong R&D pipeline exploring protein kinase regulation.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) provided a positive corporate outlook for 2023, highlighting key clinical milestones for their lead programs, zunsemetinib and ATI-1777. The company plans to release topline data for several trials, including rheumatoid arthritis and atopic dermatitis, in mid to late 2023. Aclaris is also progressing ATI-2138 for T cell-mediated diseases and ATI-2231 for oncology. An upcoming presentation at the J.P. Morgan Healthcare Conference on January 11 will further discuss the company’s developments. Aclaris aims to address unmet needs in immuno-inflammatory diseases.
Aclaris Therapeutics (NASDAQ: ACRS) and Pediatrix Therapeutics have announced a license agreement allowing Pediatrix to develop, manufacture, and commercialize ATI-1777, a soft Janus kinase (JAK) 1/3 inhibitor, for atopic dermatitis in Greater China. Aclaris will receive a $5 million upfront payment and could earn up to $91 million in milestone payments, alongside tiered royalties on net sales. This partnership aims to address the unmet medical needs for patients in the region, enhancing the global potential of Aclaris’ drug development efforts.
Aclaris Therapeutics has announced significant leadership changes effective January 1, 2023. Dr. Neal Walker will transition to Chair of the Board, while Dr. Douglas Manion is appointed CEO, succeeding Walker. Kevin Balthaser takes over as CFO following Frank Ruffo's retirement, and Matthew Rothman is appointed General Counsel. These transitions reflect Aclaris' strategic evolution in developing novel drug candidates for immuno-inflammatory diseases, emphasizing a leadership team with substantial pharmaceutical experience.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced participation in two healthcare investor conferences in November 2022. On November 16, at 5:00 PM GMT/12:00 PM EST, Dr. Neal Walker, CEO, will engage in a fireside chat at the Jefferies London Healthcare Conference.
Additionally, on November 29 at 9:30 AM EST, he will participate in another fireside chat at the 34th Annual Piper Sandler Healthcare Conference in New York. Webcasts for both events will be available on Aclaris' website and archived for 30 days.
Aclaris Therapeutics (NASDAQ: ACRS) announced significant developments in its drug pipeline, completing enrollment in the Phase 2a trial of zunsemetinib for hidradenitis suppurativa, with topline data expected in mid-2023. Additionally, the company reported a patent license agreement with Lilly, generating $17.6 million in revenue. Financially, Aclaris reported a net loss of $20.0 million for Q3 2022, an improvement from $21.1 million in Q3 2021, yet R&D expenses rose to $23.7 million due to ongoing clinical trials. The company’s cash reserves stand at $248.1 million, projected to fund operations through 2025.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced the appointment of Robert A. Doody Jr. as Vice President of Investor Relations on September 27, 2022. CEO Neal Walker expressed enthusiasm about strengthening the team with experienced industry veterans. Doody brings nearly 20 years of experience in biotechnology and has previously held investor relations positions at Provention Bio, Idera Pharmaceuticals, and ViroPharma. His expertise is expected to enhance Aclaris' engagement with investors as the company develops novel drug candidates for immuno-inflammatory diseases.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced that Dr. Neal Walker, CEO, will present a company overview at the H.C. Wainwright 24th Annual Global Investment Conference. The virtual presentation will be accessible on-demand starting September 12, 2022, at 7:00 a.m. ET. Management will be available for virtual 1x1 meetings throughout the day. A webcast of the presentation will be available on Aclaris' website for at least 30 days. Aclaris focuses on developing innovative drug candidates for patients with immuno-inflammatory diseases.
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