BLTE

Belite Bio, Inc is a clinical-stage biotechnology company developing novel therapies for underserved ophthalmic diseases affecting the retina. Headquartered in Cranbury, New Jersey, with research operations in China, Belite Bio is pioneering treatments for retinal degenerative diseases including Stargardt disease and dry age-related macular degeneration (AMD). The company's lead programs target the visual cycle, a biochemical pathway in the retina critical for vision, where dysfunction leads to toxic byproduct accumulation and photoreceptor cell death in various inherited and age-related retinal diseases. Belite Bio's lead candidate is LBS-008 (tinlarebant), an orally administered small molecule visual cycle modulator being developed for Stargardt disease, the most common inherited retinal dystrophy causing progressive vision loss in children and young adults. LBS-008 is designed to slow the accumulation of toxic vitamin A byproducts that cause retinal damage in Stargardt disease. The company has completed Phase 2 clinical trials showing encouraging safety and efficacy signals and is advancing toward pivotal Phase 3 studies. Belite is also developing LBS-008 for geographic atrophy, an advanced form of dry AMD affecting millions of elderly patients globally. The company addresses significant unmet needs in retinal degenerative diseases where treatment options are limited or nonexistent. Stargardt disease has no approved therapies, while geographic atrophy represents a large and underserved market with recent drug approvals providing validation for slowing disease progression. Belite Bio's oral small molecule approach offers potential advantages in convenience, manufacturing, and distribution compared to intravitreal injections required for many retinal therapies. The company has secured orphan drug designations and other regulatory incentives. Success depends on demonstrating efficacy and safety in pivotal trials, securing regulatory approvals, establishing commercial partnerships, and ultimately delivering therapies that preserve vision for patients with devastating retinal diseases. Belite continues advancing its clinical programs while managing development timelines and capital resources efficiently.