Aclaris Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

- Positive Results from Phase 2a Trial of ITK/JAK3 Inhibitor ATI-2138 Presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Further Validating ITK as Therapeutic Target; Initiation of Phase 2 Trial in an Additional Indication Expected in the First Half of 2026 -

- Timelines Reiterated for Top Line Clinical Results from Ongoing Trials of Investigational Anti-TSLP Monoclonal Antibody Bosakitug (ATI-045) and Anti-TSLP/IL-4R Bispecific Antibody ATI-052 -

- Initiation of Phase 1b Proof-of-Concept Trials of ATI-052 in Asthma and Atopic Dermatitis (AD) Expected in the First Half of 2026 -

- Strong Cash Runway Expected to Fund Operations into the Second Half of 2028 -

WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2025 and provided a corporate update.

“Aclaris is advancing a diversified pipeline of product candidates designed to overcome the limitations of existing therapies for certain immuno-inflammatory disorders, and the third quarter was a period of continued execution in that regard,” said Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “The strong top line results from our Phase 2a trial of ATI-2138 in atopic dermatitis are emblematic of our execution during the quarter. As we described during our October R&D Day, our progress is tangible and significant. We have two immune franchise areas in oral kinase inhibitors and biologics which we expect to drive four clinical stage product candidates in 2026, addressing validated and therapeutically relevant immune targets. We have an expected cash runway that provides nearly three years of capital with opportunities to expand it further without dilution and look forward to a rich calendar of anticipated clinical milestones and data events throughout 2026 and 2027.”

Third Quarter 2025 Highlights and Recent Updates

Pipeline:

Oral Inhibitors: ITK Franchise

• Announced Anticipated Phase 2 Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3, in an Additional Indication: Aclaris expects to further assess ATI-2138 in additional unaddressed chronic, inflammatory, immune-mediated disorders, such as Lichen planus, scarring alopecias, and alopecia areata. The Company intends to initiate a Phase 2 trial in the first half of 2026.
• Achieved Primary and Key Secondary Endpoints in Phase 2a Trial of ATI-2138: Positive top line results from this open-label, single arm trial further confirmed the favorable tolerability profile of ATI-2138, demonstrated clinically meaningful improvements from baseline in assessments of disease severity in patients with moderate-to-severe atopic dermatitis receiving low doses of ATI-2138, and validated ITK as a therapeutic target. (press release here)
• Additional Results on Robust Clinical Activity and Reductions in Fibrosis and Systemic Inflammation from ATI-2138 Phase 2a Trial Provided in Oral Presentation During the 2025 European Academy of Dermatology and Venereology (EADV) Congress: Additional results included week 4 decreases (n=9) of 77% in Eczema Area and Severity Index (EASI) score (p