ATI-052 / Biosion, Aclaris - LARVOL DELTA

Biologics: Antibody Franchise (GlobeNewswire) - "Top Line Results Expected in Early 2026 from Phase 1a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Portion of Ongoing Phase 1a/1b Program of Investigational Bispecific Anti-TSLP/IL-4R Antibody ATI-052...Following completion of the Phase 1a SAD/MAD portion, the Company expects to initiate these Phase 1b POC studies in the first half of 2026, with top line results expected in the second half of 2026."

New P1 trial • P1 data • Asthma • Atopic Dermatitis • Immunology

Second Quarter 2025 and Year-to-Date 2025 (Aclaris Press Release) - "Research and development (R&D) expenses were $11.4 million and $23.0 million for the quarter and six months ended June 30, 2025, respectively, compared to $8.8 million and $18.6 million for the corresponding prior year periods. The increases were primarily driven by product candidate manufacturing costs, preclinical development activities, and clinical development expenses associated with the Phase 2 trial in AD for bosakitug and the Phase 1a/1b program for ATI-052. For the six-month comparison period, clinical development expenses associated with the Phase 2a trial in AD for ATI-2138 also contributed to the increase."

Commercial • Alopecia • Atopic Dermatitis

Aclaris Therapeutics Initiates Phase 1a/1b Program for its Novel Bispecific Antibody ATI-052 (GlobeNewswire) - "Aclaris Therapeutics...announced that it has initiated a placebo-controlled Phase 1a/1b program for ATI-052, the Company’s potential best-in-class investigational bispecific anti-TSLP/IL-4R antibody. The program will consist of a Phase 1a single and multiple ascending dose (SAD/MAD) portion in healthy volunteers, followed by an expected Phase 1b proof of concept portion....'We expect to complete the Phase 1a SAD/MAD portion by year-end 2025 and provide top line results in early 2026, followed by the top line results from the Phase 1b portion in the second half of 2026.'"

P1 data • Trial status • Immunology

Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody (GlobeNewswire) - "Aclaris Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody....The randomized, blinded, placebo-controlled, Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept portion in an undisclosed indication. The Company expects to initiate the trial in the second quarter of 2025."

IND • New P1 trial • Immunology

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Confirmed Expectation of Phase 2 Data in the First Half of 2025 for Bosakitug in Chinese Patients with Certain Pulmonary Disorders:..Data from trials in severe asthma and CRSwNP expected in first half of 2025 to inform internal development programs. Initiated Clinical Trial Activities for a Phase 2b Trial of Bosakitug in Atopic Dermatitis (AD); Enrollment Expected to Begin in the First Half of 2025...Confirmed Expectation of Top Line Results in the First Half of 2025 for Phase 2a Trial in AD of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor...Announced Plan to File an Investigational New Drug (IND) Application for ATI-052 in the First Quarter of 2025..."

IND • New P2b trial • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Pulmonary Disease • Ulcerative Colitis

Biosion Announces Exclusive, Global License Agreement with Aclaris Therapeutics on two potential First-in-Class and Best-in-Class Immunology Assets (PRNewswire) - "Biosion, Inc...today announced that it has entered into an exclusive license agreement with Aclaris Therapeutics...for worldwide rights (excluding Greater China) to BSI-045B, a potential First-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R. Under the terms of the agreement, Biosion shall receive over $40 million cash payment as upfront license fee and reimbursement for certain development costs & drug product materials. Biosion shall also receive 19.9% shares of common stock of Aclaris Therapeutics. Additional regulatory and sales milestone payments exceed $900M with tiered low-to-mid single digit royalty based upon a percentage of annual net sales."

Licensing / partnership • Asthma • Atopic Dermatitis • Immunology