Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 358

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 358
---
 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
interim data and final data could significantly harm our business prospects.

We may not be able to file INDs or IND amendments or comparable
applications to commence clinical trials on the timelines we expect, and even if we are able to, the FDA or other regulatory authorities
may not permit us to proceed.

We may not be able to file Investigational New Drug (“IND”)
applications or other comparable applications for our product candidates on the timelines we expect. For example, we or our third party
collaborators may experience manufacturing delays or other delays with IND-enabling studies or FDA or other regulatory authorities
may require additional preclinical studies that we did not anticipate. Moreover, we cannot be sure that submission of an IND or other
comparable application will result in the FDA or other regulatory authorities allowing clinical trials to begin, or that, once begun,
issues will not arise that result in a decision by us, by institutional review boards or independent ethics committees, or by the FDA
or other regulatory authorities to suspend or terminate clinical trials, including as a result of a clinical hold. Additionally, even
if FDA or other regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or comparable
application, we cannot guarantee that they will not change their requirements or expectations in the future. These considerations also
apply to new clinical trials we may submit as amendments to existing INDs or to a new IND or other comparable application. Any failure
to file INDs or other comparable applications on the timelines we expect