Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 10

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 10
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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. On February 26, 2025, an independent Data and Safety Monitoring Board (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 when 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 May 2025, the FDA has granted Breakthrough Therapy Designation for Tinlarebant for 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. See “Recent Developments” below for more information.

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