Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 497

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 497
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 NO showed statistical significance when compared to control.

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.

9

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

NTM lung infection is a rare and
serious pulmonary disease associated with increased morbidity and mortality. Patients with NTM lung disease may experience a multitude
of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum and fatigue. Patients with NTM lung
disease, specifically Mycobacterium abscessus (M. abscessus) representing 20% to 25% of all NTM and other forms of NTM that
are refractory to antibiotic therapy, frequently require lengthy and repeated hospital stays to manage their condition. There are
no treatments specifically indicated for the treatment of M. Abscessus lung disease in North America, Europe or Japan.

There are approximately 50,000
to 90,000 people with NTM infections in the U.S. In Asia, the number of patients suffering from NTM surpasses what is seen in the U.S.
There is one inhaled antibiotic approved for the treatment of refr