WAYNE, PA — Aclaris Therapeutics Inc. (Nasdaq: ACRS) reported its financial results for the fourth quarter and full year of 2025 and provided updates on several clinical-stage drug development programs, the company announced.
The company said interim Phase 1a trial results for ATI-052, an investigational antibody designed to target TSLP and IL-4Rα pathways, showed favorable safety and tolerability in single and multiple ascending dose studies.
Complete top-line results from the Phase 1a trial are expected in the second quarter of 2026, according to the company.
Aclaris also said Phase 1b proof-of-concept trials of ATI-052 in patients with atopic dermatitis and asthma are underway, with top-line results anticipated in the second half of 2026.
The company said planning is underway for a Phase 2b program evaluating ATI-052 in asthma and atopic dermatitis.
Aclaris also confirmed that top-line results are expected in the second half of 2026 from an ongoing Phase 2 trial evaluating bosakitug, an investigational anti-TSLP monoclonal antibody, in patients with moderate to severe atopic dermatitis.
The company said it plans to submit an Investigational New Drug application in the second half of 2026 for ATI-9494, an oral inhibitor targeting interleukin-2–inducible T-cell kinase.
Aclaris also reported preclinical data for ATI-2138, an investigational inhibitor of ITK and JAK3.
In a murine model of severe alopecia areata, the compound produced mean hair regrowth of 93% after six weeks compared with 78% for the same dose of ritlecitinib, according to the company.
Mice receiving a control treatment showed no hair regrowth, the company said.
Financially, Aclaris reported a net loss of $19.8 million for the fourth quarter of 2025 compared with a net loss of $96.6 million in the same quarter of 2024.
Total revenue for the quarter was $1.3 million compared with $9.2 million a year earlier.
Research and development expenses increased to $16.6 million in the quarter from $9.0 million in the prior-year period.
The company said the increase was driven by manufacturing and development costs for bosakitug and ATI-052 as well as preclinical development for ATI-9494.
General and administrative expenses rose to $5.6 million from $5.0 million in the same quarter a year earlier.
For the full year ended December 31, 2025, Aclaris reported a net loss of $64.9 million compared with a net loss of $132.1 million in 2024.
Total revenue for the year was $7.8 million compared with $18.7 million in the prior year.
Research and development expenses for the year increased to $52.6 million from $33.6 million in 2024.
General and administrative expenses totaled $22.0 million for the year compared with $22.2 million the previous year.
As of December 31, 2025, the company reported cash, cash equivalents and marketable securities totaling $151.4 million compared with $203.9 million at the end of 2024.
Aclaris said its available cash and investments are expected to fund operations into the second half of 2028.
Chief Executive Officer Neal Walker said recent clinical developments have advanced the company’s research programs.
“2026 started with derisking events for two of our key programs, ITK and ATI-052,” Walker said.
He added that the company expects multiple clinical and research milestones during 2026 as trials progress across its pipeline.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.