WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) reported third-quarter 2025 financial results and outlined continued progress across its expanding immuno-inflammatory pipeline, emphasizing execution in both oral kinase inhibitors and biologic programs.
The company highlighted strong top-line results from its Phase 2a trial of ATI-2138, a dual ITK/JAK3 inhibitor, presented at the 2025 European Academy of Dermatology and Venereology Congress. The data demonstrated clinically meaningful improvements in disease severity for patients with moderate-to-severe atopic dermatitis and further validated ITK as a therapeutic target. Aclaris plans to initiate a Phase 2 trial of ATI-2138 in an additional indication during the first half of 2026.
Aclaris also reaffirmed timelines for bosakitug (ATI-045), an anti-TSLP monoclonal antibody, and ATI-052, an anti-TSLP/IL-4R bispecific antibody. Top-line results from ongoing clinical studies are expected in 2026, with Phase 1b proof-of-concept trials for ATI-052 in asthma and atopic dermatitis scheduled to begin in the first half of the year.
“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. “The strong top line results from our Phase 2a trial of ATI-2138 in atopic dermatitis are emblematic of our execution during the quarter. We have two immune franchise areas in oral kinase inhibitors and biologics which we expect to drive four clinical stage product candidates in 2026.”
In addition to its R&D progress, Aclaris reiterated that it expects to maintain a strong cash runway into the second half of 2028. As of September 30, 2025, the company reported $167.2 million in cash, cash equivalents, and marketable securities, compared with $203.9 million at the end of 2024.
For the third quarter of 2025, Aclaris posted a net loss of $14.6 million, compared to $7.6 million during the same period in 2024. Total revenue for the quarter was $3.3 million, down from $4.3 million a year earlier, reflecting fewer milestone payments from prior licensing agreements. Research and development expenses totaled $13.0 million, driven by manufacturing and clinical development costs for ATI-2138, ATI-045, and ATI-052. General and administrative expenses were $4.9 million, down from $5.7 million in the prior year.
Aclaris plans to provide further updates on its nomlabofusp development program and regulatory milestones in early 2026 as it prepares for additional Phase 2 and Phase 1b trial initiations.
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