Company: OSRH
Filing Date: 2025-06-23
Form Type: 424B3
Source: 0001213900-25-056351
Chunk: 14

Company: OSR Holdings, Inc.
Filing Date: 2025-06-23
Form: 424B3
Chunk 14
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 anticipates that its first oral cancer vaccine candidate beyond VXM01 could enter clinical trials within the next 3-5 years, with potential regulatory approval in the next 7-9 years. Information about the clinical trials in connection with VXM01 is set forth under Item 1 of our Current Report on Form 10-K filed with the SEC on April 22, 2025, and incorporated herein by reference. Darnatein Corporate Overview Darnatein is developing design-augmented (DA) biologics for age-related and other degenerative diseases, such as osteoarthritis and spine and joint disorders. Darnatein’s lead DA biologics are intended to be injected directly into pathological tissues to promote regeneration of target tissues such as bone or cartilage cells. Leveraging these innovative DA biologics to regenerate bone and cartilage has the potential to restore functionality and reduce pain across several degenerative conditions.

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Darnatein has identified and advanced two therapeutic
candidates, DRT-102, a clinical-stage asset for spinal fusion, and DRT-101, a pre-clinical stage asset for osteoarthritis.
A small exploratory, clinical trial of 15 patients with DRT-102 indicated potential efficacy compared to a placebo, with no serious
adverse events reported. Safety and efficacy evaluation will be determined following review of all safety data by relevant regulatory
agencies. Larger clinical trials will be required to provide more extensive and accurate data on the safety and effectiveness of DRT102.
A pre-clinical (non-human) trial of DRT-101 demonstrated cartilage regeneration and joint healing in animals, with no serious
adverse events reported. Based on these preliminary results, Darnatein intends to continue the development and testing of DRT-101 and,
when additional resources are available, DRT-102. Darnatein has not previously advanced any therapeutic candidates into late-stage clinical
trials nor received regulatory and marketing approvals for any commercial sales of its products.

Opportunity

Age-related degeneration, such as osteoarthritis
and spine disorders, is a naturally occurring process that may be accelerated due to chronic and cumulative impact over time. Limited
therapeutic options exist and only offer limited and temporary symptomatic relief with no cure currently available.

Beyond therapeutic options, invasive surgical
procedures may be available for spine and joint disorders but are not readily accessible and may not be a curative, pain-free,