Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 102

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part II, Item 8
Chunk 102
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 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.

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 refractory Mycobacterium avium complex
(“MAC”). Current guideline-based approaches to treat NTM lung disease involve multi-drug regimens of antibiotics that may
cause severe, long lasting side effects, and treatment can be longer than 18 months. Median survival for NTM MAC patients