Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 409

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 409
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 SAEs included brain edema, epilepsy, stroke,

248

hyponatremia, gait disturbance, and pulmonary embolism, which are commonly reported symptoms in patients with brain tumors or severe illnesses as their disease progresses and were not attributable to VXM01 administration. A safety evaluation will be determined following review of all safety data by relevant regulatory agencies. All patients (n=28; 100%) experienced multiple AEs, but no treatment -limitingtoxicities (TLT) related to VXM01 or avelumab, or infusion -relatedadverse events (AEs) were recorded for any group. No treatment -relatedSAEs were recorded for the 10 6CFU/mL and 10 7CFU/mL resectable groups. No VXM01- or avelumab -relatedSAEs or treatment -emergentSAEs were recorded for any group. One patient discontinued study treatment due to rheumatoid arthritis which occurred after the first 5 weeks of treatment. This adverse event was assessed as unrelated to VXM01 administration and occurred independently of the patient's underlying condition, thus it was not reported as TLT. Four patients experienced a total of 5 (five) immune -relatedAEs (irAEs). These immune -relatedAEs included hypothyroidism, autoimmune thyroiditis, fatigue, and the aforementioned rheumatoid arthritis. As with other reported events, these immune -relatedAEs were assessed and determined to be unrelated to VXM01 administration.

| Adverse Event Category                |     | 106 CFU/mL (N=3) n (%) E |     | 107 CFU/mL (N=25) n (%) E |
| Drug related SAEs                     |     | —                        |     | —                         |
| Drug related Treatment-Emergent SAEs  |     | —                        |     | —                         |
| TLT Related to VXM01                  |     | —                        |     | —                         |
| TLT Related to avelumab               |     | —                        |     | —                         |
| Infusion-related Adverse Events       |     | —                        |     | —                         |
| Immune-related Adverse Events         |     | —                        |     | 4 (16.0) 5                |
| Treatment Discontinuations Due to AEs |     | —                        |     | 1 (4.0) 1                 |
| Study Discontinuations