Belite Bio (BLTE) Company presentation summary

Executive leadership and expertise

• Leadership team includes experienced executives with backgrounds in biotech, ophthalmology, and capital markets.

• CEO has overseen over 10 new drug developments across multiple therapeutic areas.

• CMO has 25+ years in retinal diseases and led major studies in Stargardt disease.

• CSO has led clinical development for first-in-class ophthalmic drugs and introduced key disease models.

• CFO has managed over $32 billion in transactions and brings strong financial expertise.

Pipeline and market opportunity

• Tinlarebant is an oral treatment targeting Stargardt disease (STGD1) and geographic atrophy (GA), both with significant unmet needs.

• NDA for STGD1 accepted by FDA with Priority Review; PDUFA date set for February 12, 2027.

• No FDA-approved treatments exist for STGD1 or orally administered treatments for GA.

• Tinlarebant holds multiple regulatory designations, including Breakthrough Therapy and Orphan Drug status.

• Patent protection extends until at least 2040.

Mechanism of action and disease rationale

• Tinlarebant reduces retinol delivery to the eye by binding RBP4, aiming to slow toxic byproduct formation in the visual cycle.

• Targets bisretinoid-mediated toxicity, a root cause of retinal degeneration in STGD1 and GA.

• Similar pathology in STGD1 and GA supports broad applicability.