Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 405

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 405
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0239 (paired t -test). Additionally, there was a decrease in regulatory T -cells(Treg), which are immune cells that suppress immune responses. The median number of Treg cells dropped from 32 cells/mm² in the primary tumor to 12 cells/mm² in the recurrent tumor. This resulted in a higher CD8:Treg ratio, which has been associated with better clinical outcomes in other studies. VXM01 phase I clinical trial — Safety result In this trial, there were no notable differences observed between the two dose groups (10 6CFU and 10 7CFU). All patients experienced at least one treatment -emergentadverse event (TEAE), but most were mild or moderate in severity and considered unrelated to VXM01. The most common TEAEs were consistent with the underlying disease or progression of disease, and included aphasia, hemiparesis, fatigue, headache, and lymphopenia. No treatment -limitingtoxicities (TLTs) were observed. Four TEAEs (flatulence, dizziness, fatigue, and nausea) were considered related to VXM01, but all were mild and resolved without intervention. All serious adverse events (SAEs) and deaths were attributed to the underlying disease or disease progression.

| Adverse after prime and boosting doses |     | 106 CFU (N=7) n (%) E |     | 107 CFU (N=6) n (%) E |
| Drug related TEAEs                     |     | 1 (14.3) 2            |     | 2 (33.3) 2            |
| Drug related SAEs                      |     | —                     |     | —                     |
| Drug related Treatment-Emergent SAEs   |     | —                     |     | —                     |
| TLTs Related to VXM01                  |     | —                     |     | —                     |
| Treatment Discontinuations Due to AEs  |     | —                     |     | —                     |
| Study Discontinuations Due to AEs      |     | —                     |     | —                     |

Note: A hyphen (-) indicates no events were reported. E = number of events; n = number of patients with an event; N = number of patients. Percentages are based on the number of patients. CFU: colony forming units. VXM01 phase I/II clinical trial — Patient selection criteria Patients were selected by a third party clinical trial provider, each