Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 21

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 21
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 process of establishing our own commercialization capabilities, we will incur significant additional costs, including to hire and retain qualified personnel to build out our commercialization team and sales force. Recruiting and training such a sales force is expensive and time-consuming and could delay any product launch. We may be unable to build out this commercialization team and sales force in a way that will enable us to successfully commercialize our products and generate revenues. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and other commercialization capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses, and our investment may be lost if we cannot retain or reposition our commercialization personnel.

There can be no assurance that we will be able to successfully develop our in-house sales, commercial distribution and commercialization capabilities or successfully commercialize any product, and as a result, we may not be able to generate product sales revenue.

**Risks Related to Our Financial Position and Need for Additional Capital**

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.

We are a global clinical-stage biopharmaceutical company with a limited operating history and no history of commercializing pharmaceutical products. Our operations to date have been limited to financing and staffing our company, developing our technology and conducting preclinical research and clinical trials for our product candidates. We have not yet demonstrated an ability to successfully obtain marketing approvals for or commercialize our product candidates or manufacture our product candidates on a scale sufficient to supply

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the commercial markets. We may need to invest significant additional capital to establish our in-house commercialization team, sales network and systems, which could strain our financial resources and impact our ability to achieve profitability. We have no products approved for commercial sale and have not generated any revenue from product sales. Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history and/or approved products on the market.

Our limited operating history and the fact that we have yet to commercialize a pharmaceutical product, particularly in light of the rapidly evolving drug research and development industry in which we operate and the changing regulatory and market environments we encounter, may make it difficult to evaluate our prospects for future performance. As a result, any assessment of our future performance or viability is subject to significant uncertainty. We will encounter risks and difficulties