Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 402

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 402
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 determined by blood and urine tests); able to undergo MRI scans; no active infection at the time of vaccination; Karnofsky performance status greater than 70; and adequate blood counts. • No recent clinical trials:no participation in another clinical trial within 30 days before screening. • No specific infections:negative test results for Hepatitis B, Hepatitis C, and HIV. • No interfering conditions:no other medical or social conditions that might interfere with 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 (%)