Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 79

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 79
---
 were enrolled.

Two additional adolescent STGD1 subjects were also enrolled, giving a total of 13 adolescent STGD1 subjects for the Phase 2 portion. Genotyping data showed that all 13 subjects harbored severe biallelic mutations which would predict pathogenicity. The PD data from the Phase 1b portion revealed that during repeated daily dosing, Tinlarebant produces a sustained mean RBP4 reduction of >70%, relative to baseline. A total of 12 subjects completed the Phase 2 portion of the study (1 subject was lost to follow

<div align='center'>3</div>

TABLE OF CONTENTS

up at Month 12). The 24-month data continued to support Tinlarebant’s safety profile and showed no growth of atrophic retinal lesions (referred to as definitely decreased autofluorescence or DDAF) in 5 of 12 subjects. In the 7 subjects showing DDAF lesion growth, the growth rate was significantly reduced when compared to historical control data obtained from adolescent STGD1 patients who participated in a 24-month natural history study known as ‘ProgStar’. Based on data from the Phase 1b/2 study, a Phase 3 clinical trial named “DRAGON” in adolescent STGD1 patients was initiated. This study, which is a global, multi-center, randomized, double masked, placebo-controlled study designed to evaluate the safety and efficacy of Tinlarebant in the treatment of adolescent STGD1 patients, has completed enrollment of 104 subjects. Interim analysis of the Phase 3 DRAGON trial is anticipated to be conducted by the Data and Safety Monitoring Board (DSMB) in early 2025.

To support the clinical development of Tinlarebant in GA, in addition to the foregoing Phase 1 and 1b/2 studies described above, we have also completed a Phase 1b 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. A dose that produces the desired PD effect against RBP4 was identified.

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