Company: OSRH
Filing Date: 2025-06-10
Form Type: S-1/A
Source: 0001213900-25-053114
Chunk: 14

Company: OSR Holdings, Inc.
Filing Date: 2025-06-10
Form: S-1/A
Chunk 14
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 to permit the public to make comments. These Advisory Committees include a Patient Representative that provides input from the patient perspective. The estimated timeframe for this process is as follows:

| ● | Antigen discovery and vaccine formulation: 1-2 years |

| ● | Preclinical studies: 1-2 years |

| ● | IND filing and review: 1 month |

| ● | Phase 1/2 clinical trials: 2-3 years |

| ● | Phase 3 clinical trials: 2-3 years |

| ● | Regulatory approval (including NDA review): 1 year |

Based on this timeline, Vaximm 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.

6 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