Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 127

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part II, Item 8
Chunk 127
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 showed no difference compared to control for all efficacy endpoints, while 150 ppm NO showed
statistical significance when compared to control.

 29 

Additionally,
long-term safety data for high concentration inhaled NO in bronchiolitis was presented at the Pediatric Academic Societies Meeting 2022
(PAS 22), which was held in Denver, Colorado from April 21, 2022 through April 25, 2022. 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 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.

Current
estimates place the number of people with NT