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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 plans for a public offering of $75 million in common stock, subject to market conditions. The company will offer up to an additional 15% of shares through a 30-day underwriter option. Jefferies LLC, SVB Leerink LLC, and Piper Sandler & Co. are leading the offering, with a registration statement already filed and effective as of May 20, 2021. The offering aims to generate funds for Aclaris' drug development pipeline targeting immuno-inflammatory diseases. However, there's no assurance of completion or specifics regarding the offering.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced positive preliminary results from its Phase 2a trial of ATI-1777, a topical JAK inhibitor for moderate to severe atopic dermatitis. The trial showed a statistically significant reduction in the modified Eczema Area and Severity Index (mEASI) score by 74.4% in the ATI-1777 group compared to 41.4% in the control. The drug was generally well tolerated with no serious adverse events. Aclaris plans to advance ATI-1777 to Phase 2b development following these findings. Management will discuss the results in a conference call today at 8 AM ET.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced that Dr. Neal Walker, President and CEO, will present at the Jefferies Virtual Healthcare Conference on June 1, 2021, at 1:00 p.m. ET. This presentation will provide an overview of the company's efforts in developing innovative drug candidates for immuno-inflammatory diseases. Aclaris' management will also be available for virtual one-on-one meetings throughout June 1st. The presentation can be viewed live on Aclaris' website, and the archive will be accessible for 30 days.
Aclaris Therapeutics (NASDAQ: ACRS) reported Q1 2021 results with a net loss of $28.8 million, up from $15.6 million in Q1 2020. Total revenue increased to $1.8 million from $1.4 million. The company holds $142.7 million in cash and equivalents, sufficient to fund operations through 2023. Aclaris is advancing its drug pipeline with a Phase 2b trial for ATI-450 in rheumatoid arthritis and two additional trials for hidradenitis suppurativa and psoriatic arthritis. Results from the Phase 2a trial of ATI-1777 for atopic dermatitis are expected in Q2 2021.
Aclaris Therapeutics (NASDAQ: ACRS) has completed enrollment in its Phase 2a clinical trial of ATI-1777, a topical JAK 1/3 inhibitor for treating moderate to severe atopic dermatitis. The trial, which is randomized and double-blind, aims to assess the drug's efficacy and safety. Results are anticipated by mid-2021. This milestone follows positive preliminary results from another trial of ATI-450 for rheumatoid arthritis. Aclaris continues to develop treatments targeting immuno-inflammatory diseases and aims to demonstrate ATI-1777's potential while minimizing systemic exposure.
Aclaris Therapeutics (NASDAQ: ACRS) announced promising preliminary topline data for ATI-450, an oral MK2 inhibitor, from its Phase 2a trial in moderate to severe rheumatoid arthritis. This investigational drug showed significant clinical activity with sustained reductions in DAS28-CRP scores and enhanced inflammatory biomarker suppression over 12 weeks. For Q4 2020, Aclaris reported a net loss of $13.2 million, a decrease from $18.6 million in Q4 2019, along with total revenues of $1.6 million. Following a public offering in January 2021, Aclaris secured $103.5 million to strengthen its balance sheet.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced that Dr. Neal Walker, President and CEO, will present at two upcoming virtual investor conferences. The presentations include the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, at 7:00 a.m. ET, and the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 10:00 a.m. ET. Management will also be available for virtual one-on-one meetings on both days. Webcasts of the presentations can be accessed on Aclaris' website and will be archived for 30 days.
Aclaris Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the 10th Annual SVB Leerink Global Healthcare Conference on February 25, 2021. Management will engage in a virtual fireside chat at 8:00 a.m. ET and will be available for one-on-one meetings throughout the day. Investors can access a live audio webcast of the chat on the company's website, which will be archived for 30 days. Aclaris focuses on developing innovative drug candidates for immuno-inflammatory diseases, leveraging a strong R&D pipeline.
Aclaris Therapeutics (Nasdaq:ACRS) has priced its underwritten public offering of 5,483,714 shares at $17.50 each, targeting gross proceeds of approximately $96 million. The offering includes a 30-day option for underwriters to purchase an additional 822,557 shares. Expected to close on or about January 22, 2021, this capital raise, facilitated by Cantor Fitzgerald & Co. and William Blair & Company, aims to support Aclaris' ongoing clinical-stage development in immuno-inflammatory diseases.
Aclaris Therapeutics (Nasdaq: ACRS) announced its intention to conduct an underwritten public offering of its common stock, subject to market conditions. The offering will include a 30-day option for underwriters to purchase an additional 15% of the shares. Cantor Fitzgerald & Co. and William Blair & Company are joint book-running managers for the offering. A shelf registration statement for these shares was filed with and declared effective by the SEC. The offering will be made via a prospectus supplement and will not constitute an offer without proper registration.
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