Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 322

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 322
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 development
plans or expand them. If we are unable to raise capital when needed or on acceptable terms, we may be forced to delay, reduce or eliminate
one or more of our research and drug development programs or future commercialization efforts.

Based on our current operating plan, and in part due to the cancellation
of our previously anticipated PIPE Investment, following the closing of our Business Combination there still remains some doubt as to
our ability to fund our operating expenses and capital expenditure going forward, and, as noted by our auditor, our ability to survive
as a going concern. A more detailed discussion of this agreement is included in Part II, Item 7, “Management’s Discussion
and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources.” Despite the fact that
we appear to have obtained alternative financing under our ELOC Agreement, our actual capital requirements may also vary significantly
from what we expect, and we will in any event require additional capital in order to complete clinical development of any of our current
programs. Our monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time
and necessary activities associated with the development of our product candidates are highly uncertain, we are unable to estimate the
actual funds we will require for development, marketing and commercialization activities. Our future funding requirements, both near and
long-term, will depend on many factors, including, but not limited to:

●the initiation, progress, timing, costs and results of preclinical
studies and clinical trials for our product candidates, including whether and when to advance our diverse portfolio of product candidates;

●the clinical development plans we establish for these product
candidates;

●the timelines of our clinical trials and the overall costs to
finish the clinical trials;

●the number and characteristics of product candidates that we
develop;

●the outcome, timing and cost of meeting regulatory requirements
established by the FDA, European Medicines Agency and other comparable foreign regulatory authorities;

●the cost of filing, prosecuting, defending and enforcing our
patent claims and other intellectual property rights;

44

●the cost of defending intellectual property disputes, including
patent infringement actions brought by third parties against us or our product candidates;

●the extent to which we enter into additional collaboration agreements
with regard to product discovery or acquire or in-license products or technologies;

●the effect of competing technological and market developments;

●the cost and timing of completion of commercial-scale outsourced
manufacturing activities; and

●the