Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 120

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 120
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 or termination of, our clinical
trials will delay the submission of an NDA/BLA or other similar applications to the FDA or other relevant comparable non-U.S. regulatory
authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate product revenues. Even if
our clinical trials are completed as planned, we cannot be certain that their results will support our claims for differentiation or
the effectiveness or safety of our product candidates. The FDA has substantial discretion in the review and approval process and may
disagree that our data support the differentiated claims we propose. In addition, only a small percentage of product candidates under
development result in the submission of an NDA/BLA or other similar application to the FDA and other comparable non-U.S. regulatory
authorities and even fewer are approved for commercialization.

62

Interim, top-line or preliminary data from our clinical
trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification
procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or top-line data
from our clinical trials, which is based on a preliminary analysis of then-available top-line data, and the results and related
findings and conclusions are subject to change following a full analysis of all data related to the particular trial. We also make assumptions,
estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully
and carefully evaluate all data. As a result, the preliminary and top-line results that we report may differ from future results
of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully
evaluated. Top-line data also remain subject to audit and verification procedures that may result in the final data being materially
different from the top-line data we previously published. As a result, preliminary and top-line data should be viewed
with caution until the final data are available. From time to time, we may also disclose interim data from our clinical trials. Interim
data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change
as patient enrollment continues and more patient data become available. Adverse differences between preliminary, top-line or
inter