Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 355

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 355
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 principal investigators for our clinical trials may serve
as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain
circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The
FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has
created a conflict of interest or otherwise affected interpretation of the study. The FDA or comparable foreign regulatory authority
may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial
itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable
foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product
candidates.

Our product development costs will increase if we experience additional
delays in preclinical or clinical testing or in obtaining marketing approvals. We do not know whether any of our clinical trials will
begin as planned, will need to be restructured or will be completed on schedule, or at all. If we do not achieve our product development
goals in the time frames we announce and expect, the approval and commercialization of our product candidates may be delayed or prevented
entirely. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize
our product candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully
commercialize our product candidates and harming our business and results of operations. Any delays in our clinical development programs
may harm our business, financial condition and results of operations significantly.

61

Clinical trials and pre-clinical studies are very expensive, time-consuming,
and difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not
be able to conduct or complete clinical trials or pre-clinical studies on the expected timelines, if at all.

Clinical trials and pre-clinical studies are very expensive,
time-consuming and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The FDA,
an IRB or other regulatory authorities may not agree with the proposed analysis plans or trial design for the clinical trials of our product
candidates, and during any such review, may identify unexpected efficacy or safety concerns, which may delay