Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 15

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 15
---
 a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates.

•

The manufacture of biopharmaceutical products is a complex process which requires significant expertise and capital investment, and if we encounter problems in our collaboration with third parties for the manufacture for clinical or commercial scale or in the manufacture of our future products, our business could suffer.

•

We have limited experience in launching and marketing product candidates and are in the process of building an in-house commercialization team and we may not be able to effectively build and manage a sales network with the necessary technical expertise and supporting distribution capabilities to successfully commercialize our product candidates;

•

We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.

•

Inadequate funding for and other disruptions at the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, affect the review and process of regulatory submissions, prevent new products from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business;

•

Current and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain;

•

Our future success depends on our ability to attract, retain and motivate senior management and qualified employees;

<div align='center'>S-8</div>

TABLE OF CONTENTS

•

We will rely on third parties to manufacture clinical and commercial supplies of Tinlarebant and other product candidates and future products;

•

As a result of our principal shareholder, Lin Bioscience International Ltd.’s significant share ownership position in us, it is able to influence corporate matters and a conflict of interest may arise between our principal shareholder and us. In addition, a change of control in Lin Bioscience International Ltd., may result in a change of control of the Company or of its Board of Directors or its management, which may have a material adverse effect on our business, financial condition and results of operations; and

•

We will no longer qualify as an “emerging growth company” as of December 31, 2025 and, as a result, we will no longer be able to avail ourselves of certain reduced reporting requirements applicable to emerging growth companies.

#### Change in Emerging Growth Company Status
As of June 30,