Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 49

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 1
Chunk 49
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haled NO treated patients. Patients with unstable
oxygen saturation during hospitalization, 66.7% of the inhaled NO treatment group, reached stable saturation of ≥93% during hospital
stay as compared to 26.7% in the SST group.

Following
completion of the clinical trial and the 180-day follow-up period, incremental data were provided in a poster presentation at IDWeek
2022. In addition to the positive clinical results provided at ECCMID 2022, the poster showed a larger decline in c-reactive protein
(“CRP”) from baseline for patients treated with NO + SST compared to the control group. Analysis of the data provides compelling
evidence that high concentration NO delivery with the LungFit® PRO generator and delivery system can be a powerful tool against any
type of pneumonia, especially COVID-19. The Company commenced a clinical trial in the second half of calendar 2023 in the United States
and 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