Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 40

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 40
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 Initially, with a smaller sample size of 15 patients,
the p-value is 0.132, indicating no statistically significant difference between the two groups. However, as the sample size increases
to 23 patients, the p-value drops to 0.039, suggesting a statistically significant difference favoring the test group.

With a moderate sample size of 30 patients, the p-value further
decreases to 0.026, indicating stronger statistical evidence of the difference in success rates between the control and test groups.
Finally, in the largest sample size of 60 patients, the p-value reaches 0.002, demonstrating a statistically significant difference.
Throughout the analysis, the test group outperformed the control group in success rates.

Development plans for DRT-101 and DRT-102

Based on preliminary tests of DRT-101 and DRT-102, Darnatein intends
to expand the potential application of DRT-101 to other cartilage regeneration targets, including spinal cartilage in the treatment
of lower back pain. Darnatein may, depending upon securing additional financial resources and other opportunities requiring investment,
expand the potential application of DRT-102 to other bone regeneration targets, including non-fusion bone fracture in the treatment
of deformed bone tissue. Darnatein’s strategy generally involves the following key steps:

1. Identify novel drug
candidate for cartilage- and bone-degenerative disorders: Darnatein will leverage its expert knowledge and experience in tissue regenerative
medicine to identify new cartilage- and bone-degenerative disorders that can be targeted by Darnatein’s DRT-101 and DRT-102 platforms.

2. Conduct preclinical
studies with the FDA’s good laboratory practice (“GLP”) regulations: Before testing any drug or biological product candidate
in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally
involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to
assess the potential for adverse events and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies
is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. Darnatein will first perform
preclinical studies to evaluate