Company: BLTE
Filing Date: 2025-10-22
Form Type: F-3ASR
Source: 0001104659-25-101403
Chunk: 10

Company: BELITE BIO, INC
Filing Date: 2025-10-22
Form: F-3ASR
Chunk 10
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 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. On September 12, 2025, we completed the Phase 3 DRAGON trial and expect top-line results in the fourth quarter of 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. 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 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.