Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 401

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 401
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) 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 of whom met the following criteria: • Diagnosis:confirmed glioblastoma (WHO Grade IV) located above the tentorium cerebelli in the brain. • Disease progression:evidence of tumor growth after receiving standard treatment with radiation and temozolomide chemotherapy. • Prior treatment:completion of radiotherapy at least 3 months before entering the trial. • Resectable tumors (subset of patients):eligible for a repeat surgery to remove the tumor, with the surgery able to be delayed for 30 days. • General health:good bone marrow, liver, and kidney function; able to undergo MRI scans; no active serious infections; and a Karnofsky performance status of 70 or higher (meaning they could mostly care for themselves). • Tumor samples:availability of tumor tissue for analysis. • Sex:men were eligible. Women had to be post -menopausalor surgically sterile due to a lack of safety data on the vaccine’s potential impact on reproduction. With these criteria, the trial recruited 25 patients with non -resectabletumors and 3 with