Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 516

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 516
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 randomized 1:1:1 to receive either SOC (typically oxygen and hydration) or SOC plus inhaled NO at 85 ppm or SOC plus inhaled NO at
150 ppm for 40 minutes 4 times per day for up to 5 days. There were no SAEs related to NO therapy. Efficacy results are shown in the table
below.

    150 ppm vs. 85 ppm 
Hazard Ratio (p-value)
     
    150 ppm vs. SST 
Hazard Ratio (p-value)
  
    Fit for Discharge
     
    2.11 (0.041)
     
    2.32 (0.049)
  
    Hospital Length of Stay (LOS)
     
    2.01 (0.046)
     
    2.28 (0.043)
  
    Oxygen Saturation of > 92%
     
    2.15 (0.056)
     
    2.62 (0.039)

We plan to seek certification
or regulatory approval for our remaining current product candidates and, if approved, we expect they will be marketed as medical devices.

If we reach the commercialization
stage for any of our remaining product candidates, we expect that we will collaborate with companies outside the U.S. for all indications.
We are still determining whether to attempt to collaborate for any indication in the U.S. We are commercializing LungFit®
PH in the U.S. ourselves and expect to partner with third parties to commercialize LungFit® PH outside the U.S.

18

Our PreClinical Results to Date for LungFit®

We have completed 4 separate toxicology
studies in animals.

    ● 
    Rats: 30 days of intermittent treatments with LungFit® at 400 ppm NO showed no observations (differences) between control rats and treated rats on observation during the treatment period prior to sacrifice and no observations on histopathology 

    ● 
    Rats: 12 weeks of intermittent treatments with LungFit® at 250 ppm NO showed no observations (differences) between control rats and treated rats on observation during the treatment period prior to sacrifice and no observations on histopathology 

    ● 
    Dogs: 12 weeks of intermittent treatments with LungFit® at 250 ppm NO showed no observations (differences) between control dogs and treated dogs on observation during the treatment period prior to sacrifice and no observations on histopathology

    ● 
    Rats: Gen