Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 509

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 509
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 ppm and control
  
    2020-2022
    Pilot; randomized, controlled (n=35)
    VCAP (due to any virus, including COVID-19)
    Safety & Efficacy
    No SAEs related to treatment; 150 ppm NO showed statistically significant improvement in duration of oxygen use 
  
    2020-2022
    Pilot open label (n=15)
    NTM (all strains)
    Safety & Efficacy
    All patients titrated to 250 ppm NO with no treatment related discontinuations during 11+ weeks of self-administration at home; Improvements in QoL
  
    2021-2022
    Pilot; randomized, controlled (n=101)
    Bronchiolitis Long Term Follow-up
    Safety
    Favorable long term safety profile based on re-hospitalization rate

15

Cystic Fibrosis and NTM Clinical Development

In 2011, a prospective, open label,
controlled, single-center pilot safety study was conducted on ten healthy adults between 20 and 62 years of age. The data were published
in the Journal of Cystic Fibrosis in 2012. Subjects received 160 ppm NO for 30 minutes, five times a day, for five consecutive days via
direct inhalation to the lungs using a prototype delivery system. The primary objective of the study was to determine the effect of inhaled
160 ppm NO on pulmonary function tests and characterize the relationship between high-concentration NO administration and MetHb –
a form of hemoglobin that is a biproduct of NO and hemoglobin that cannot bind oxygen – and establish a MetHb safety threshold level
to assess adverse events associated with the treatment. Secondary objectives of the study were to assess the changes in cytokine levels.
Multiple safety markers were continuously monitored including: NO levels, NO2 (a biproduct of NO and O2 that can
be toxic at high concentrations), FiO2, as well as MetHb and oxygen saturation (“SaO2”). Vital signs,
lung function, blood chemistry (including nitrite/nitrates), hematology, prothrombin time, inflammatory cytokine/chemokines levels and
endothelial activation (angiopoietin ratio) were also closely monitored. All individuals tolerated the NO formulation treatment courses
well. No SAEs occurred. The maximum amount of air one can forcefully exhale in one second, known as forced expiratory volume