Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 13

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 13
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 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).

8

●Tumor samples: availability of tumor tissue for
analysis.

●Sex: men were eligible. Women had to be post-menopausal or
surgically sterile due to a lack of