Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 410

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 410
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 Darnatein is developing design -augmented(DA) biologics for age -relatedand 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. Darnatein has identified and advanced two therapeutic candidates, DRT -102, a clinical -stageasset for spinal fusion, and DRT -101, a pre -clinicalstage asset for osteoarthritis. A small exploratory, clinical trial of 15 patients with DRT -102indicated potential efficacy compared to a placebo, with no serious adverse events reported. Full safety and efficacy evaluation will be determined following further 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 -101demonstrated 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 -101and, when additional resources are available, DRT -102. Darnatein has not previously advanced any therapeutic candidates into late -stageclinical trials nor received regulatory and marketing approvals for any commercial sales of its products. Opportunity Age -relateddegeneration, 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, long -termsolution. Additionally, neither symptomatic therapies nor invasive and costly surgical procedures address the underlying cause of chronic and age -relateddegenerative diseases. Darnatein’s novel Design Augmented (DA) approach has the potential to overcome these limitations of spine and joint disorders and osteoarthritis with a regenerative therapy to overcome degeneration in bone and cartilage. Design-Augmented Biologics Program In recent years, scientists have studied the role of bone morphogenetic proteins (BMPs) in healing bone