Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 182

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 182
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 orders also restrict the use and dissemination outside of the United States, or the sharing with certain non -U.S. nationals, of information products classified for national security purposes, as well as certain products, technology and technical data relating to those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit our growth potential and increase our development costs. The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions. Risks Related to the Development of New OSR Holdings’ Product Candidates The following risk factors reference the risks and uncertainties relating to the development of product candidates by OSR Holdings, which, following the closing of the Business Combination, will be the development of product candidates by New OSR Holdings. References in this section to “we,” “us,” and “our” refer to OSR Holdings prior to the closing of the Business Combination and to New OSR Holdings after closing. Our business includes subsidiaries that are developing oral immunotherapies for the treatment of cancer and design-augmented biologics. These companies have a limited operating history, and their programs are in early stages of development. This may make it difficult to evaluate our prospects and likelihood of success. Our business includes subsidiaries that are (i) developing oral immunotherapies for the treatment of cancer, and (ii) developing design -augmentedbiologics for age -relatedand other degenerative diseases. Each of these subsidiaries is an early -stagecompany with a limited operating history, has no pharmaceutical products approved for commercial sale and has not generated any revenue from sales of its products. Our approach to the discovery and development of any therapeutic product candidates is unproven, and we do not know whether we will be able to 97 develop any products of commercial value. These product candidates will require substantial additional development and clinical research time and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales. We do not yet have substantial experience progressing therapeutic product candidates through clinical trials. We may be unable to demonstrate safety and efficacy in clinical trials, obtain regulatory approval, manufacture at a commercial scale, or arrange for a