Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 353

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 353
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 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 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