Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 508

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 508
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 neurological conditions. If our clinical trials for our product candidates
are successful, we expect to seek certification or marketing approval from the FDA and other worldwide authorities and notified regulatory
bodies.

Our Clinical Results to Date

We have conducted several clinical
trials to assess our 150-250 ppm NO inhalation-treatment in various indications. These trials include:

    Date
    Study
    Indication
    Primary
    Results
  
    2011
    Pilot Safety (n=10)
    All comers 
    Safety
    No SAEs
  
    2013 – 2014
    Proof of Concept (“POC”) double blind randomized (n=43)
    Bronchiolitis (due to any virus)
    Safety & Efficacy
    No SAEs; 24 hour reduction in hospital length of stay
  
    2013 – 2014 
    Pilot open label (n=9)
    Cystic Fibrosis (CF)
    Safety & Efficacy
    No SAEs; Lowered bacterial load
  
    2016
    Compassionate use investigator sponsored research (“ISR”) (n=2)
    NTM abscessus (CF)
    Safety & Efficacy
    No SAEs; clinical & surrogate endpoints improved
  
    2017
    Compassionate use National Institute of Health, U.S. (n=1)
    NTM abscessus (CF)
    Safety & Efficacy
    No SAEs; Improvements in clinical endpoints
  
    2017
    Pilot open label (n=9)
    NTM abscessus
    Safety & Efficacy
    No SAEs; clinical & surrogate endpoints improved
  
    2017-2018
    Pilot; double blind randomized (n=68)
    Bronchiolitis (due to any virus)
    Safety & Efficacy
    No SAEs; 27 hour reduction in hospital length of stay
  
    2018
    Compassionate use ISR (n=1)
    NTM abscessus (CF)
    Safety
    No SAEs at 250 ppm NO dose
  
    2019-2020
    Pilot; double blind randomized (n=87) 
    Bronchiolitis (due to any virus)
    Safety & Efficacy
    No SAEs; 150 ppm treatment showed statistically significant improvements in primary and key secondary endpoints compared to both 85