Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 17

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 17
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. No treatment-related SAEs
were recorded for the 106 CFU/mL and 107 CFU/mL resectable groups. No VXM01- or avelumab-related SAEs
or treatment-emergent SAEs 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-related AEs (irAEs). These immune-related AEs included hypothyroidism, autoimmune thyroiditis, fatigue, and the aforementioned
rheumatoid arthritis. As with other reported events, these immune-related AEs 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 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.

Intellectual Property

Vaximm actively maintains 8 patent families relating to Vaximm’s
portfolio of assets, in the United States and in other major markets as described shown in the tables below of specific patents within