Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 116

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 116
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 particular;
or

●varying interpretations of data by the FDA and similar foreign
regulatory agencies.

We do not have complete control over many of these factors, including
certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and
our manufacturing, marketing, distribution and sales efforts or that of any future collaborator.

60

We may incur additional costs or experience delays in completing,
or ultimately be unable to complete, the development of any of our product candidates, which may adversely impact our results of operations
and financial condition.

We may experience delays in initiating or completing clinical trials.
Clinical trials can be delayed or terminated for a variety of reasons, including:

●regulators or institutional review boards (“IRB”)
or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective
trial site;

●the FDA or other comparable regulatory authorities may disagree
with our clinical trial design, including with respect to dosing levels administered in our planned clinical trials, which may delay
or prevent us from initiating our clinical trials with our originally intended trial design;

●we may experience delays in reaching, or fail to reach, agreement
on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, which can be subject to extensive
negotiation and may vary significantly among different CROs and trial sites;

●The number of participants required for clinical trials of any
product candidates may be larger than we anticipate or participants may 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