Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 357

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 357
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to develop our product candidates, or could render further development impossible.

The results of our clinical trials may not support our proposed
claims for our product candidates, or regulatory approvals on a timely basis or at all, and the results of earlier studies and trials
may not be predictive of future trial results.

The results of pre-clinical studies and early clinical trials
of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages
of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical and
initial clinical trials. In addition, results from clinical trials or pre-clinical studies may require further evaluation,
delaying the next stage of development or submission of an NDA/BLA or similar application. A future failure of a clinical trial to meet
its pre-specified endpoints would likely cause us to abandon our product candidates. Any delay in, 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