Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 47

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 47
---
 of this study and we have obtained 24-month treatment data for a total of 12 subjects as of the date of this prospectus supplement. The final 24-month data of the Phase 2 trial continues to demonstrate Tinlarebant’s safety profile and show a sustained reduced DDAF lesion growth compared to natural history data from adolescent STGD1 patients who participated in a 24-month natural history study known as ‘ProgStar.’ Retinal imaging showed that 5 of 12 subjects remained free of atrophic retinal lesions (referred to as definitely decreased autofluorescence or DDAF) after 24 months of Tinlarebant treatment. In the 7 subjects showing DDAF lesion growth, the growth rate was significantly reduced when compared to historical control data obtained from ProgStar participants. Visual acuity was stabilized in majority of subjects during the study with a mean loss of five letters following 24 months of treatment (a loss of <10 letters is not considered clinically significant). It is notable that a comparison of the 24-month DDAF lesion growth between Tinlarebant-treated subjects and ProgStar participants possessing similar baseline characteristics (aged ≤18 years) showed a sustained lower DDAF lesion growth in Tinlarebant-treated subjects over the 24-month treatment period (p<0.001).

<div align='center'>S-31</div>

TABLE OF CONTENTS

Note:

*

Only 50 patients from ProgStar Cohort (aged ≤18) were included in the analysis due to one subject having ungradable screening FAF data

(1)

Strauss RW, Ho A, Muñoz B, et al. ProgStar Report No. 1. Ophthalmology. 2016;123(4):817-28.

(2)

Strauss RW, Muñoz B, Ho A, et al. ProgStar Report No. 9. JAMA Ophthalmol. 2017; 135(11):1232-1241.

Phase 1b/2 Safety Results

Adverse events reported during the Phase 1b study were consistent with Tinlarebant’s mechanism of action and included delayed dark adaptation (DDA) and transient chromatopsia in 7 of 11 subjects (or 63.6%), which were all graded as mild. It is notable that the majority of DDA cases required confirmation by laboratory measure (dark adaptometry) as many subjects were asymptomatic. The