IBIO · iBio, Inc.

iBio, Inc. has achieved a critical milestone by securing Clinical Trial Notification acknowledgement from Australia’s Therapeutic Goods Administration (TGA) and ethics approval from a Human Research Ethics Committee, clearing the path for its first-in-human Phase 1 clinical trial of IBIO-600. This randomized, double-blind, placebo-controlled, single ascending dose study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in overweight and obese adults, with first dosing targeted for Q2 2026. IBIO-600, a potentially best-in-class long-acting monoclonal antibody targeting myostatin and GDF11, aims to preserve lean muscle mass and improve body composition, addressing muscle loss associated with GLP-1 therapies in obesity treatment. Preclinical data in non-human primates showed sustained activity, extended half-life of 40-52 days, and dose-dependent lean mass increases up to 5.1% alongside fat mass reductions. This rapid progression to clinic just two years post-program initiation underscores the efficiency of iBio's AI-integrated discovery platform. Simultaneously, the announcement fulfills conditions for the previously issued Series G Warrants from the August 19, 2025 offering, setting their expiration 30 trading days later on May 12, 2026. With 27,945,000 Series G Warrants outstanding as of the filing date, full exercise would result in issuance of 27,945,000 common shares plus accompanying Series H Warrants for another 27,945,000 shares (or pre-funded warrants). This dual development advances iBio toward clinical-stage status while introducing potential dilution risk for shareholders upon warrant exercises.