Company: BLTE
Filing Date: 2025-12-02
Form Type: 424B5
Source: 0001104659-25-117702
Chunk: 19

Company: BELITE BIO, INC
Filing Date: 2025-12-02
Form: 424B5
Chunk 19
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 preclinical studies or manufacturing validation studies and submit that data before it will reconsider our applications. Depending on the extent of these or any other required trials or studies, approval of any NDA or application that we submit may be delayed by several years, or may require us to expend more resources than we have available. It is also possible that additional trials or studies, if performed and completed, may not be considered sufficient by the FDA, the TGA, the NMPA, the EMA or other comparable regulatory authority to approve our NDAs.

Any delay in obtaining, or an inability to obtain, marketing approvals would prevent us from commercializing our product candidates, generating revenues and achieving and sustaining profitability. If any of these outcomes occur, we may be forced to abandon our development efforts for our product candidates, which could significantly harm our business.

Although we announced the top-line results of the Phase 3 DRAGON in December 2025 and we expect to file an NDA, the foregoing risks regarding marketing approvals remain applicable to Tinlarebant. There can be no assurance that we will obtain marketing approval for Tinlarebant in a timely manner, or at all, and any delay or failure to obtain such approval could significantly harm our business and prospects.

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 currently do not have cGMP manufacturing capabilities and we are entirely dependent on third-party contractors, including contract manufacturing organizations, or CMOs, to manufacture our product candidates for our clinical trials, and we expect to rely on third-party CMOs for the production of commercial quantities of our products in accordance with cGMP regulations upon obtaining regulatory and marketing approvals. The manufacture of biopharmaceutical products is a complex process, in part due to strict regulatory requirements. If we are unable to identify and maintain collaboration with third-party CMOs, or fail to do so in a timely manner, this may lead to significant delays in the clinical supply of our product candidates as well as the commercial manufacturing of our products once regulatory and marketing approvals have been obtained. In turn, this could delay our clinical trials, negatively impact our ability to ultimately obtain regulatory approval and materially harm any future commercialization plans. For more information about risks related to reliance on third-party CMOs, please see “Risk Factors—We will rely