Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 496

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 496
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 in the second half of calendar 2023 in the United States and has made the decision to pause this
study pending future funding.

Bronchiolitis (BRO)

Bronchiolitis is the leading cause
of hospital admission in children less than 1 year of age. The incidence is estimated to be 150 million new cases a year worldwide, with
2-3% (over 3 million) of them severe enough to require hospitalization. Worldwide, 95% of all cases occur in developing countries. In
the U.S., there are approximately 120,000 annual bronchiolitis hospitalizations and approximately 3.2 million annual child hospitalizations
globally. Currently, there is no approved treatment for bronchiolitis. The treatment for acute viral lung infections that cause bronchiolitis
in infants is largely supportive care and is based primarily on prolonged hospitalization during which the infant receives a constant
flow of oxygen to treat hypoxemia, a reduced concentration of oxygen in the blood. In addition, systemic steroids and inhalation with
bronchodilators are sometimes utilized until recovery, but we believe that these treatments do not successfully reduce hospital LOS. We
believe the U.S. market potential for bronchiolitis to be greater than $500 million and worldwide market potential to be greater than
$1.2 billion.

The pivotal clinical trial for
bronchiolitis was originally set to be performed in the winter of 2020/21 but was delayed due to the COVID-19 pandemic. We have completed
three 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