Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 48

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 48
---
 findings of DDA, xanthopsia, and other visual changes were monitored and determined to be reversible. In addition, there were no clinically significant findings related to vital signs, physical exams, or electrocardiograms. There were no deaths nor serious adverse events reported and no adverse events that required discontinuation of Tinlarebant.

The 24-month safety results of the Phase 2 study showed that ocular adverse events that were considered related to Tinlarebant were reported in 12 of 13 subjects (or 92.3%). The most common ocular treatment-related adverse events included xanthopsia/chromatopsia (8 of 13 subjects, or 61.5%) and delayed dark adaptation (7 of 13 subjects, or 53.8%). No deaths nor serious or severe adverse events were reported. In addition, there were no clinically significant findings related to vital signs, physical exams, or electrocardiograms.

<div align='center'>S-32</div>

TABLE OF CONTENTS

| Treatment-Related Adverse Events | ​ | ​ | Severity |   |      |   | ​ | ​ | Frequency(#Subjects) |   |      |   | ​ |
| Xanthopsia/Chromatopsia          | ​ | ​ | ​        | ​ | Mild | ​ | ​ | ​ | ​                    | ​ | 8/13 | ​ | ​ |
| Delayed Dark Adaptation (DDA)    | ​ | ​ | ​        | ​ | Mild | ​ | ​ | ​ | ​                    | ​ | 7/13 | ​ | ​ |
| Delayed light adaptation         | ​ | ​ | ​        | ​ | Mild | ​ | ​ | ​ | ​                    | ​ | 1/13 | ​ | ​ |
| Night vision impairment          | ​ | ​ | ​        | ​ | Mild | ​ | ​ | ​ | ​                    | ​ | 1/13 | ​ | ​ |
| Visual impairment                | ​ | ​ | ​        | ​ | Mild | ​ | ​ | ​ | ​                    | ​ | 1/13 | ​ | ​ |
| Blepharospasm                    | ​ | ​ | ​        | ​ | Mild | ​ | ​ | ​ | ​                    | ​ | 1/13 | ​ | ​ |
| Headache                         | ​ | ​ | ​        | ​ | Mild | ​ | ​ | ​ | ​                    | ​