Belite Bio, Inc (NASDAQ: BLTE)

Belite Bio, a clinical-stage biopharmaceutical company, is dedicated to developing novel therapeutics targeting retinal degenerative eye diseases. The company operates under the ticker symbol BLTE on the Nasdaq Capital Market and is renowned for its groundbreaking work in the ophthalmology sector. Belite Bio's main business activities include advancing novel therapeutics to address significant unmet medical needs in the eye disease space. With a focus on retinal degenerative diseases, the company's operations span various stages of development, from preclinical research to clinical trials.

Belite Bio generates revenue primarily through licensing agreements and collaborations with other companies, as well as through the sale of its products. The company's customer base includes major pharmaceutical companies, research institutions, and government agencies. Belite Bio's competitive edge lies in its robust product pipeline, led by Tinlarebant, an orally administered, once-a-day tablet intended for the treatment of atrophic age-related macular degeneration (AMD) and autosomal recessive Stargardt disease type 1 (STGD1). This drug works by reducing the amount of retinol entering the visual cycle and preserving the health of the retina, making it a promising candidate for addressing these debilitating eye conditions.

In the STGD1 landscape, Belite Bio is well-positioned, as Tinlarebant is the only orally administered treatment in Phase 3 development. STGD1 is a rare, inherited juvenile form of macular degeneration affecting approximately 1 in 10,000 people worldwide. The disease is caused by a mutation in the ABCA4 gene, leading to the accelerated formation and accumulation of toxic vitamin A by-products, causing retinal cell death and permanent vision loss. Belite Bio's goal is to slow STGD1 progression and preserve vision through Tinlarebant.

In addition to STGD1, Belite Bio is exploring Tinlarebant's potential in treating geographic atrophy (GA) associated with dry AMD. GA is a leading cause of vision loss in older adults, with no FDA-approved treatments available. Belite Bio's Phase 3 clinical trial, "DRAGON," evaluates Tinlarebant's safety and efficacy in adolescent STGD1 patients.

Belite Bio's management team and ophthalmology clinical advisory board have deep experience and capabilities in multiple therapeutic areas and novel drug development. The company's technology platform is designed to target at-risk patients across the United States and worldwide, who lack access to necessary treatment in the macular degeneration space.