Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 43

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 43
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oid toxins.

<div align='center'>S-28</div>

TABLE OF CONTENTS

#### Clinical Development for STGD1
In September 2025, we completed the last subject visit in the Phase 3 clinical trial of Tinlarebant named “DRAGON” in adolescent STGD1 patients from the United States, the United Kingdom, Germany, Netherlands, France, Belgium, Switzerland, China, Hong Kong, Taiwan, and Australia. Previously, we completed two Phase 1 clinical trials of Tinlarebant in healthy adult subjects in mid-2020, a Phase 1b clinical trials of Tinlarebant in adolescent STGD1 subjects in late 2021, and a Phase 2 clinical trial of Tinlarebant in adolescent STGD1 subjects in late 2023. In addition, to facilitate future NDA applications in Japan, we have completed the Phase 1b PK/PD portion and are conducting a Phase 2/3 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”).

Phase 3 Clinical Trial in STGD1

Based on data from the Phase 1b/2 study, we initiated a Phase 3 clinical trial named “DRAGON” in adolescent STGD1 patients. This trial, which is a multi-center, randomized, double-masked, placebo-controlled study to evaluate the safety and efficacy of Tinlarebant in the treatment of adolescent STGD1 patients, has commenced in the U.S., the United Kingdom, Germany, Netherlands, France, Belgium, Switzerland, China, Hong Kong, Taiwan, and Australia and has completed enrollment of 104 subjects. On February 26, 2025, the DSMB conducted a pre-specified interim analysis of the DRAGON trial which included an adaptive sample size re-estimation that would determine the need for an increase in sample size in order to enhance power. The interim analysis was performed after all subjects completed the one-year assessment. Following the interim analysis, the DSMB recommended the trial proceed without any modifications, which indicates that a sample size increase is not warranted. In addition, the DSMB recommended to submit the data for further regulatory review for drug approval. According to the DSMB, Tinlarebant is well-tolerated and the safety profile remains consistent with previously observed data and the mechanism of action for Tinlarebant. In addition