Company: BLTE
Filing Date: 2025-01-27
Form Type: F-3ASR
Source: 0001104659-25-006317
Chunk: 7

Company: BELITE BIO, INC
Filing Date: 2025-01-27
Form: F-3ASR
Chunk 7
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, which shares strong pathophysiologic similarities with GA. In clinical trials, Tinlarebant has demonstrated a target specificity and potency that we believe could be clinically meaningful for STGD1 and GA patients.

As of mid-2020, we have completed one Phase 1 single ascending dose, or SAD, study in 40 healthy adult subjects in the U.S., one Phase 1 SAD study in 39 healthy adult subjects and one Phase 1 multiple ascending dose, or MAD, study in 32 healthy adult subjects in Australia. These studies involved 111 healthy adult subjects in total and evaluated the safety, toxicity, pharmacokinetics, or PK, and pharmacodynamics, or PD, of Tinlarebant.

Following completion of the Phase 1 studies, an open-label, dose-finding Phase 1b/2 clinical trial in adolescent STGD1 subjects was initiated in Australia and Taiwan. The study design included two portions: the Phase 1b portion was a 1-month dose finding study which enrolled 11 adolescent STGD1 subjects; the Phase 2 portion was a 24 month extension of the Phase 1b portion in which the 11 STGD1 subjects completing in Phase 1b 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

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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