Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 402

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 402
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 the study or make it unsafe for the patient to participate. The study included 14 white patients with a mean age of 56.8 years. The majority of participants (64.3%) were male.

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VXM01 phase I clinical trial — Tumor response The tumor response was assessed by objective response rate (ORR) according to immunotherapy Response Assessment for Neuro -Oncology(iRANO; 2015). Overall, the tumor response to VXM01 was mixed, with some patients showing signs of stable disease or even tumor shrinkage, while others experienced disease progression. These findings highlight the variability in treatment response and the challenges of managing glioblastoma. The extension study results provide further insights into the potential for long -termdisease control in some patients, but also underscore the need for further research to optimize treatment strategies and identify those most likely to benefit.

| Best Overall Response |     | 106 CFU (N=7) n (%)  |     | 107 CFU (N=6) n (%) |     | Total (N=13) n (%) |
| CR                    |     | 1 (14.3)             |     | —                   |     | 1 (7.1)            |
| PR                    |     | 1 (14.3)             |     | —                   |     | 1 (7.1)            |
| SD                    |     | 5 (71.4)             |     | 5 (83.3)            |     | 10 (76.9)          |
| PD                    |     | —                    |     | 1 (16.7)            |     | 1 (7.1)            |
| ORR (%) [95% CI]      |     | 28.6 [3.7 – 71.0]    |     | 0.0 [0.0 – 45.9]    |     | 15.4 [1.9 – 45.4]  |
| DCRR (%) [95% CI]     |     | 100.0 [59.0 – 100.0] |     | 83.3 [35.9 – 99.6]  |     | 92.3 [64.0 – 99.8] |

Note: A hyphen (-) indicates no events were reported. n = number of patients with an event; N = number of patients; NR =