Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 354

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 354
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 drop out of these clinical trials or fail to return for post-treatment follow-up at
a higher rate than we anticipate;

●our third-party contractors may fail to comply with regulatory
requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from a clinical trial protocol
or drop out of a trial, which may require that we add new clinical trial sites or investigators;

●we may need to address any safety concerns that arise during
the course of a clinical trial;

●we may experience delays and interruptions to our manufacturing
supply chain, or we could suffer delays in reaching, or we may fail to reach, agreement on acceptable terms with third-party service
providers on whom we rely;

●the cost of clinical trials of our product candidates may be
greater than we anticipate;

●logistical issues relating to any future clinical trials we
may conduct;

●we may elect to, or regulators, IRBs, Data and Safety Monitoring
Boards, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons,
including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

●we may not have the financial resources available to begin and
complete the planned trials, or the cost of clinical trials of any product candidates may be greater than we anticipate;

●the supply or quality of our product candidates or other
materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate to initiate or complete a
given clinical trial; and

●the FDA or other comparable foreign regulatory authorities
may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us
to initiate a clinical trial.

We could also encounter delays if a clinical trial is suspended or
terminated by us, by the IRBs or ethics committees of the institutions in which such clinical trials are being conducted, or by the FDA
or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure
to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols, inspection of the clinical trial
operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety
issues or adverse side effects, failure to demonstrate a benefit from the product candidates, changes in governmental regulations or administrative
actions or lack of adequate funding to continue the clinical trial.

Moreover,