Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 72

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 72
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 regulatory approvals for our current and future product candidates;

●attract and retain experienced management and advisory teams;

●add operational, financial and management information systems
and personnel, including personnel to support clinical, pre-clinical manufacturing and planned future commercialization efforts
and operations;

●achieve market acceptance of product candidates in the medical
community and with third-party payors and consumers; and

●maintain, expand and protect our intellectual property portfolio.

If we cannot successfully execute any one of the foregoing, our business
may not succeed and the price of our common shares and warrants may be negatively impacted.

If one or more of our product candidates encounters safety or efficacy
problems, development delays, regulatory issues or other problems, our development plans and business could be significantly harmed. Before
we can generate any revenue from sales of any of our product candidates, we must undergo additional preclinical and clinical development,
regulatory review and approval in one or more jurisdictions. In addition, if one or more of our product candidates are approved, we must
ensure access to sufficient commercial manufacturing capacity and conduct significant marketing efforts in connection with any commercial
launch. These efforts will require substantial investment, and we may not have the financial resources to continue development of our
product candidates.

Drug development is a highly speculative business requiring substantial
investments that may not ever generate operating cash flow.

Investment in drug development is highly speculative because it entails
substantial upfront capital and operating expenditures and significant risk that any potential product candidate will fail to demonstrate
adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. In addition, as a business
with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown
factors and risks frequently experienced by early-stage drug development companies in rapidly evolving fields.

Our product candidates will require substantial development time — including
extensive clinical, and in many cases pre-clinical, research and development — and resources before we would
be able to apply for or receive applicable regulatory approvals and begin generating revenue from product sales. Because of the numerous
risks and uncertainties associated with drug development, we are unable to predict precisely the timing or amount of increased expenses,
or when we will be able to generate any meaningful revenue or achieve or maintain profitability, if ever.

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If we obtain regulatory approval for any of our product candidates,
we still may never achieve profitability.

If we do successfully obtain regulatory approval to market