Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 11

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 11
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 dose-finding study in elderly healthy adults to determine the appropriate dose for subjects with similar age and body mass index as GA patients. This study was an open-label, parallel, single-dose, clinical trial designed to evaluate the PK and PD of Tinlarebant in healthy subjects aged between 50 to 85 years of age. Through this study, the optimal dose for subjects with similar age and body mass index as GA patients has been determined.

Based on data from the of the foregoing Phase 1b dose-finding study, we have also initiated a Phase 3 clinical trial named “PHOENIX” in GA patients. This study, which is a global, multi-center, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of Tinlarebant in patients with GA associated with dry AMD, has completed patient enrollment as of the date of this prospectus supplement with a total of 530 subjects.

In addition to the Phase 3 “DRAGON” clinical trial in adolescent STGD1 patients and the Phase 3 “PHOENIX” clinical trial in GA patients, we are conducting a clinical trial of Tinlarebant in adolescent STGD1 patients aged 12 to 20 years old in Japan, the United States and the United Kingdom (“DRAGON II”). The DRAGON II study is a combination of a Phase 1b open-label study to evaluate the PK and PD of Tinlarebant in adolescent Japanese STGD1 subjects and a 24-month, Phase 2/3, multi-center, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of Tinlarebant. We have completed the Phase 1b portion of DRAGON II and have dosed the first patient in

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the Phase 2/3 portion of the trial, which has a target enrollment of approximately 60 subjects, including approximately 10 Japanese subjects. The data from Japanese subjects is intended to facilitate future NDA applications in Japan.

#### LBS-009
LBS-009 is an anti-RBP4 oral therapy targeting liver disease, including NAFLD, NASH, and T2D. NAFLD occurs when an excess accumulation of fat damages the liver. Based on the data published by the Population Division of United Nations, it is estimated that approximately 1.8 billion adult patients suffer from NAFLD worldwide. Over time