Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 115

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 115
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experienced by early-stage companies in rapidly evolving fields. Consequently, we have no meaningful history of drug development
operations experience upon which to evaluate our drug development business, and predictions about its future success or viability may
not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing therapeutic
products.

Our product candidates will, of necessity, be subjected to pre-clinical and
clinical trials prior to commercialization. Delays in those trials, or if the results of the trials raise regulatory issues, may adversely
impact our results of operations and financial condition.

We may experience setbacks that could delay or prevent regulatory approval
of, or our ability to commercialize, our product candidates, including:

●timely completion of our preclinical studies and clinical trials;

●negative or inconclusive results from our preclinical studies
or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct
additional preclinical testing or clinical trials or abandon a program;

●the prevalence, duration and severity of potential product-related side
effects experienced by participants receiving our product candidates in our clinical trials or by individuals using drugs or therapeutics
similar to our product candidates;

●delays in submitting Investigational New Drug (“IND”)
or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial,
or a suspension or termination of a clinical trial once commenced;

●conditions imposed by the FDA or comparable foreign authorities
regarding the scope or design of our clinical trials;

●delays in enrolling participants in clinical trials;

●high drop-out rates of participants from clinical trials;

●inadequate supply or quality of product candidates or other
materials necessary for the conduct of our clinical trials;

●greater than anticipated clinical trial costs;

●inability to compete with other therapies;

●poor efficacy of our product candidates during clinical trials;

●unfavorable FDA or other regulatory agency inspection and review
of a clinical trial site;

●failure of our third-party contractors or investigators
to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;

●delays related to the impact of recessions, man-made and/or
natural disasters, pandemics, and/or any other such events;

●delays and changes in regulatory requirements, policy and guidelines,
including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in