WAYNE, PA — Aclaris Therapeutics, Inc. (Nasdaq: ACRS) outlined plans for multiple mid- and late-stage clinical milestones this year as the biotechnology company advances experimental treatments for asthma, atopic dermatitis and other immuno-inflammatory diseases.
The company expects topline data in the second half of 2026 from two Phase 1b proof-of-concept studies evaluating ATI-052, an investigational bispecific antibody being tested in asthma and atopic dermatitis patients.
Aclaris also plans to begin a Phase 2b asthma program for ATI-052 in the fourth quarter after reporting positive Phase 1a results that demonstrated extended drug activity and dosing intervals of up to three months.
The company reported completed enrollment in a Phase 2 study evaluating bosakitug, an anti-TSLP monoclonal antibody, in 109 patients with atopic dermatitis. Topline data from that trial is expected in the fourth quarter.
In its oral inhibitor portfolio, Aclaris plans to launch a Phase 2b basket study for ATI-2138 targeting multiple forms of lichen planus, a chronic inflammatory skin disorder for which no approved therapies currently exist.
The first portion of the study is expected to begin in the second half of 2026, with additional expansion planned afterward into lichen planopilaris, a subtype associated with permanent hair loss.
The company also confirmed plans to file an investigational new drug application in the second half of 2026 for ATI-9494, a preclinical inhibitor targeting inducible T-cell kinase.
Chief Executive Officer Dr. Neal Walker pointed to recent ATI-052 data as supporting the company’s broader immunology strategy.
“Most recently, the positive results from our Phase 1a SAD/MAD trial of our bispecific antibody ATI-052 confirmed its potential as having a best-in-class PK/PD profile with an extended dosing schedule of up to every three months,” Walker said in a statement.
Cash, cash equivalents and marketable securities totaled $190.8 million as of March 31, compared with $151.4 million at the end of 2025.
In March, Aclaris sold 18.4 million shares of common stock, generating gross proceeds of approximately $59.8 million through agreements with Leerink Partners and Cantor Fitzgerald.
The company expects existing liquidity to fund operations through the end of 2028.
Net loss widened to $19.8 million in the first quarter from $15.1 million a year earlier.
Research and development expenses increased to $15.7 million from $11.6 million, driven largely by clinical development work involving ATI-052 and manufacturing costs tied to ATI-9494.
General and administrative expenses rose to $6.7 million from $6.1 million, reflecting higher professional, legal and personnel costs.
Revenue increased to $2 million from $1.5 million, primarily due to higher royalty payments under licensing agreements with Eli Lilly and Company (NYSE: LLY) and Sun Pharmaceutical Industries Limited.
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