Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 308

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 308
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 of this proxy statement/prospectus.

Risks Related to the Company Business and Operations

The following risk factors reference the risks and uncertainties
relating to the business and operations of OSR, which, following the closing of the Business Combination, are the business and operations
of the Company. References in this section to “we,” “us,” and “our” refer to OSR prior to the closing
of the Business Combination and to the Company after closing.

37

The Company’s limited operating history, the early stage
of its development programs and the inherent uncertainties and risks involved in pharmaceutical product development may make it difficult
for it to execute on its business model.

We are a global drug development company with a limited operating history
upon which you can evaluate our business and prospects. Our operations to date have been limited to organizing and staffing our company,
business planning, raising capital, acquiring our portfolio companies, establishing our intellectual property portfolio and performing
research and development in support of our product candidates. We have no pharmaceutical product candidates approved for commercial sale
and our product candidates have not generated any revenue. Our approach to the discovery and development of product candidates from early
stage to drug launch is unproven, and we do not know whether we will be able to develop any products of commercial value. Except for a
few clinical stage candidates in our portfolio, most of our other candidates are in the preclinical stages of development and will require
additional preclinical studies and future clinical development as well as regulatory review and approval, which may not be granted. Since
we are still in preclinical and clinical development, we would need to receive regulatory approvals, gain access to sufficient commercial
manufacturing capacity and implement marketing efforts before we could begin generating revenue from product sales or arrange for a third
party to do so on our behalf.

The Company will likely incur significant operating losses for
the foreseeable future and may never achieve or maintain profitability.

We have never generated any operating profits and incurred operating
losses of KRW 784.7 million and KRW 14.8 billion for years ending 2022 and 2023, respectively, and operating
loss of KRW 15.9 billion for the year ending December 31, 2024. We have an accumulated deficit of KRW 28.18 billion as
of December 31, 2024. We are likely to continue to incur operating losses in the future. While our RMC subsidiary generated revenues of
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