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About Aclaris Therapeutics Inc.
Aclaris Therapeutics Inc. (NASDAQ: ACRS) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for immuno-inflammatory diseases and dermatological conditions. With a mission to address significant unmet medical needs, Aclaris leverages its expertise in protein kinase regulation to develop a robust pipeline of novel drug candidates. The company operates in two primary segments: therapeutics, focusing on drug discovery and development, and contract research, offering laboratory services that generate a majority of its revenue.
Therapeutic Focus and Pipeline
Aclaris’ therapeutic portfolio targets immuno-inflammatory diseases and dermatological conditions where current treatment options are inadequate. Its pipeline includes small and large molecule candidates, such as:
- Zunsemetinib: An oral MK2 inhibitor for immuno-inflammatory conditions.
- ATI-2138: A dual ITK/JAK3 inhibitor aimed at T cell-mediated autoimmune diseases, including atopic dermatitis.
- ATI-1777: A topical treatment for inflammatory skin conditions.
- BSI-045B: An anti-TSLP monoclonal antibody with potential applications in atopic dermatitis and respiratory diseases.
- BSI-502: A bispecific antibody targeting TSLP and IL4R pathways, enhancing its versatility in addressing chronic inflammatory conditions.
These candidates reflect Aclaris’ commitment to addressing gaps in treatment by focusing on mechanisms such as cytokine signaling and immune cell modulation.
Research & Development Capabilities
Aclaris’ R&D engine is a cornerstone of its strategy, exploring innovative approaches to protein kinase regulation. This expertise enables the company to develop differentiated therapies that target complex biological pathways. Notably, its proprietary technologies support the discovery and optimization of both small molecules and biologics, positioning Aclaris to compete in diverse therapeutic areas.
Strategic Partnerships and Market Position
To bolster its pipeline and financial flexibility, Aclaris has pursued strategic partnerships and licensing agreements. Recent collaborations include licensing rights to BSI-045B and BSI-502, which complement its existing portfolio and expand its reach into respiratory and autoimmune diseases. Additionally, Aclaris’ agreement with Eli Lilly for OLUMIANT® royalties demonstrates its ability to monetize assets while maintaining focus on internal programs.
Competitive Landscape
Aclaris operates in a competitive biopharmaceutical market, facing challenges from established players and emerging startups. Its dual focus on dermatology and immunology, combined with a diversified pipeline, sets it apart. By addressing high-value indications and leveraging its expertise in kinase regulation, Aclaris aims to carve out a significant niche in the biopharma space.
Commitment to Innovation and Patient Needs
With a patient-centric approach, Aclaris is committed to delivering therapies that improve quality of life for individuals with chronic and underserved conditions. Its focus on both medical and aesthetic dermatology, alongside immuno-inflammatory diseases, underscores its versatility and dedication to addressing diverse healthcare needs.
Conclusion
Aclaris Therapeutics Inc. stands as a dynamic player in the biopharmaceutical industry, driven by innovation and a commitment to addressing unmet medical needs. Through its strategic initiatives, robust R&D capabilities, and diversified pipeline, the company is well-positioned to make significant contributions to the fields of dermatology and immunology.
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.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced promising topline results from a 12-week, Phase 2a trial of ATI-450, an investigational oral MK2 inhibitor, for rheumatoid arthritis. The study showed durable clinical activity, with a significant 2.0 reduction in DAS28-CRP scores and 40% of treatment subjects achieving low disease activity by week 12. ATI-450 was generally well tolerated, with no serious adverse events reported. The company plans to advance ATI-450 to Phase 2b trials and publish full data analysis in a scientific journal.
Aclaris Therapeutics (ACRS) announced the establishment of a new Scientific Advisory Board comprising leading experts in immuno-inflammatory diseases. The board includes Drs. Stanley Cohen, Marco Colonna, James Krueger, and Michael Weinblatt, who bring extensive experience in rheumatology and immunology. Additionally, Aclaris expects preliminary topline data from the ATI-450-RA-201 Phase 2a trial for rheumatoid arthritis in January 2021. This development aims to enhance Aclaris’ R&D efforts in addressing unmet medical needs in immuno-inflammatory conditions.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced its participation in a virtual fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on December 2, 2020, at 7:30 a.m. ET. Management will also be available for one-on-one virtual meetings on December 1 and 2. Investors can access a live audio webcast of the event through the company's website, with an archived version available for 30 days. Aclaris is focused on developing novel drug candidates for immuno-inflammatory diseases, supported by a robust R&D platform.
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