Company: XAIR
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021561
Chunk: 50

Company: Beyond Air, Inc.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 1
Chunk 50
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 successful pilot studies for bronchiolitis. A further analysis of the three previously reported pilot
studies was presented at the ATS International Conference 2021. Analysis across the studies (n=198 infants, mean age 3.9 months) showed
that 150 ppm – 160 ppm NO administered intermittently was generally safe and well tolerated with adverse event rates similar among
treatment groups with no reported treatment-related serious adverse events. The short course of treatments with intermittent high concentration
inhaled NO was effective in shortening hospital LOS and accelerating time to fit for discharge – a composite endpoint of clinical
signs and symptoms to indicate readiness to be evaluated for hospital discharge. This treatment was also effective in accelerating time
to stable oxygen saturation – measured as SpO2 ≥ 92% in room air. Additionally, NO at a dose of 85 ppm NO showed no difference
compared to control for all efficacy endpoints, while 150 ppm NO showed statistical significance when compared to control.

26

Additionally,
long-term safety data for high concentration inhaled NO in bronchiolitis was presented at the Pediatric Academic Societies Meeting 2022
(PAS 22). A total of 101 infants from the three prior pilot studies for bronchiolitis (n=198) participated in the long-term follow-up
clinical trial. Clinical trial endpoints for the long-term safety clinical trial included percentage of patients re-hospitalized for
bronchiolitis related reasons, such reasons included wheezing episodes, pneumonia, and asthma and the percentage of patients re-hospitalized
for any reason. Data from the clinical trial showed the re-hospitalization rate per 100 Patient Exposure Years (PEY) due to bronchiolitis
related reasons trended favorably for the inhaled NO group. In addition, the long-term patient re-hospitalization rate for any reason
was similar between inhaled NO and control groups. As such, the clinical trial concluded that the treatment of hospitalized infants with
acute bronchiolitis by intermittent high dose inhaled NO shows a favorable long-term safety profile.

We
believe that the entirety of data at 150 ppm – 160 ppm NO in both adult and infant patient populations supports further development
of LungFit® PRO in a pivotal clinical trial for patients hospitalized with VCAP or bronchiolitis.

LungFit®
GO for the treatment of Nontuberculous mycobacteria (NTM)

NTM
lung infection is a rare and serious pulmonary disease