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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, a clinical-stage biopharmaceutical company (NASDAQ: ACRS), announced that Dr. Neal Walker, its President and CEO, will join a fireside chat at the SVB Leerink Virtual 11th Annual Global Healthcare Conference on February 16, 2022, at 9:20 a.m. ET. Aclaris management will also be available for virtual one-on-one meetings that day. The fireside chat webcast can be accessed via the company's website and will be archived for 30 days. Aclaris focuses on developing novel treatments for immuno-inflammatory diseases, backed by a strong R&D pipeline.
Aclaris Therapeutics has appointed James Loerop as Chief Business Officer, effective January 31, 2022. Loerop brings over two decades of experience in business development, most recently serving as Executive Vice President at Anika Therapeutics. His expertise is expected to enhance Aclaris' global business development strategy for its drug pipeline targeting immuno-inflammatory diseases. Additionally, John Schindler, Ph.D., has been named Senior Director of Discovery Research, focusing on early-stage targets.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has announced updates on its clinical programs and R&D operations as of January 11, 2022. Two Phase 2 studies of Zunsemetinib for rheumatoid arthritis (RA) and hidradenitis suppurativa (HS) are underway, aiming to evaluate efficacy and optimal dosing. Additionally, the company has initiated a first-in-human Phase 1 trial of ATI-2138, targeting T-cell mediated autoimmune diseases. Notably, Aclaris has strengthened its R&D team and is planning to fill key leadership positions following the departure of Chief Medical Officer David Gordon.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company, announced participation by Dr. Neal Walker, its President and CEO, in a fireside chat at the H.C. Wainwright BioConnect Virtual Conference. The event will be available starting January 10, 2022, at 7:00 a.m. ET, and interested parties can access the webcast through the "Events" page on Aclaris' website. The company is focused on developing innovative drug candidates for immuno-inflammatory diseases, addressing significant unmet medical needs.
Aclaris Therapeutics (NASDAQ: ACRS) announced the publication of preclinical research on zunsemetinib in pancreatic cancer in the journal Science Translational Medicine on December 1, 2021. This study, conducted in collaboration with Washington University School of Medicine, identifies the MK2/HSP27 axis as a key survival mechanism for pancreatic cancer cells under chemotherapy stress. Results showed that zunsemetinib significantly increased mouse survival when combined with FOLFIRINOX therapy. Aclaris is considering advancing this research into clinical trials for pancreatic cancer treatment.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced that the FDA has allowed its Investigational New Drug (IND) application for ATI-2138, an oral ITK/TXK/JAK3 inhibitor aimed at treating psoriasis. The company is set to provide more details on this and other drug candidates during a virtual R&D Day on December 7, 2021. Topics will include ATI-450 and ATI-2231, both MK2 inhibitors, and an Oral Gut-restricted Discovery Program. Participation in this event can be accessed via conference call or webcast from Aclaris’ website.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced participation in two upcoming investor conferences. Dr. Neal Walker, President and CEO, will engage in a virtual fireside chat at the Jefferies London Healthcare Conference on November 18, 2021, at 3:00 a.m. ET. Additionally, he will participate in the Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22, 2021, at 10:00 a.m. ET. Virtual one-on-one meetings will also be available. Live webcasts can be accessed via Aclaris’ website, and recordings will be archived for 30 days.
Aclaris Therapeutics (NASDAQ: ACRS) reported a net loss of $21.1 million for Q3 2021, compared to $10.7 million in Q3 2020, with total revenue of $1.7 million, up from $1.4 million year-over-year. R&D expenses surged to $14.0 million, influenced by efforts to advance zunsemetinib, an investigational drug for rheumatoid arthritis. The company holds $243.6 million in cash and equivalents, projected to sustain operations through 2024. Additionally, an investigational new drug application for ATI-2138 was submitted, marking potential expansion in immuno-inflammatory treatments.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced a Settlement Hearing set for November 30, 2021, regarding the Consolidated Derivative Action in the U.S. District Court for the Southern District of New York. Judge Lewis J. Liman granted preliminary approval for the settlement on August 18, 2021, which includes corporate governance reforms and attorneys' fees paid by Aclaris' insurer. Stockholders can object to the Proposed Settlement until November 16, 2021. Final approval from the Court is not assured.
Aclaris Therapeutics, a clinical-stage biopharmaceutical company listed on NASDAQ under the symbol ACRS, announced their participation in two upcoming investor conferences. Dr. Neal Walker, President and CEO, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, and at the 2021 Cantor Virtual Global Healthcare Conference on September 27, 2021. Both events will include opportunities for virtual one-on-one meetings. Webcasts of the presentations will be available on the Aclaris website for 30 days.