Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 13

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 13
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point compared to placebo.

<div align='center'>S-6</div>

TABLE OF CONTENTS

Statistical analysis revealed a 35.7% reduction in the annualized lesion growth rate in the Tinlarebant group compared to placebo. This treatment effect was determined to be highly statistically significant (p=0.0033) signifying achievement of the primary endpoint. A post-hoc analysis performed using MMRM with the autoregressive covariance matrix produced a consistent result showing Tinlarebant group had a 35.4% reduction in lesion size (p <0.0001).

Tinlarebant (5 mg orally, daily) was well tolerated in adolescent STGD1 patients. No drug or trial discontinuation due to non-ocular adverse events. There were 4 drug discontinuations that were related to the treatment. Xanthopsia and delayed dark adaptation are the most common drug related ocular adverse events. The majority of xanthopsia, delayed dark adaptation, and night vision impairment were mild, and most resolved during the trial. Headaches were the most commonly reported treatment-related non-ocular adverse event.

#### Organizational Structure
The following diagram illustrates our corporate structure as of the date of this prospectus supplement:

#### Summary of Risk Factors
An investment in the ADSs is subject to a number of risks that if realized could materially affect our business, financial condition, results of operations, cash flows and access to liquidity. Investors should carefully consider all of the information in this prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein and therein before making an investment in the ADSs. The following list summarizes some, but not all, of these risks. Please read the information in the section entitled “ Risk Factors ” in this prospectus supplement and in our most recent Annual Report on Form 20-F for a more thorough description of these and other risks.

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Our business is highly dependent on the success of our lead product candidate, Tinlarebant (a/k/a LBS-008). If we are unable to develop, obtain marketing approval for or successfully commercialize Tinlarebant, either alone or through a collaboration, or if we experience significant delays in doing so, our business could be harmed;

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All of our product candidates are in clinical or preclinical development. If we are unable to complete clinical development and obtain regulatory approval to ultimately commercialize our product candidates, or if we experience significant delays in doing so, our business, financial condition,