Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 44

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 44
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, visual acuity was stabilized in the majority of subjects, with mean change from baseline of less than three letters under both standard and low luminance, throughout the two-year study. In May 2025, the FDA granted Breakthrough Therapy Designation for Tinlarebant in the treatment of STGD1. As of the date of this prospectus supplement, China’s NMPA has agreed to accept a New Drug Application with priority review for Tinlarebant in the treatment of Stargardt disease based on the interim analysis results of the DRAGON trial. Additionally, the United Kingdom’s MHRA has agreed to accept a Conditional Marketing Authorization application for Tinlarebant in the treatment of Stargardt disease based on the interim analysis results of DRAGON trial.

In September 2025, we completed the last subject visit in the Phase 3 DRAGON trial. In December 2025, we announced the top-line results of the Phase 3 DRAGON trial. The primary endpoint in the DRAGON trial was the difference in annualized aggregate lesion growth rates (detected as definitely decreased autofluorescence, DDAF) between the Tinlarebant and placebo groups over the 2-year treatment period. Lesion growth rates were analyzed using a mixed model for repeated measures (MMRM) and a pre-specified unstructured covariance matrix. As shown in the table below, there was a progressive separation of the lesion growth trajectories throughout the treatment period in which the Tinlarebant group showed reduced lesion growth at every measured timepoint compared to placebo.

<div align='center'>S-29</div>

TABLE OF CONTENTS

Statistical analysis revealed a 35.7% reduction in the annualized lesion growth rate in the Tinlarebant group compared to placebo. This treatment effect was determined to be highly statistically significant (p=0.0033) signifying achievement of the primary endpoint. A post-hoc analysis performed using MMRM with the autoregressive covariance matrix produced a consistent result showing Tinlarebant group had a 35.4% reduction in lesion size (p <0.0001). Additionally, Tinlarebant achieved a reduction in RBP4 levels by a mean of approximately 80% relative to baseline. Mean RBP4 levels returned to 84% of baseline one to three months following drug cessation, and recovery of RBP4 concentration correlated well with the decreased Tinlarebant exposure.

Tinlare