Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 512

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 512
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 related
to NO reported.

Additionally in 2017, we completed
a single-arm, open-label Pilot trial in nine patients with M. abcessus lung disease, who were refractory to standard-of-care (“SOC”).
The patients were treated with inhaled NO at a concentration of 160 ppm for 30 minutes, in addition to treatment with SOC. Our inhaled
NO treatment was administered intermittently five times per day over a 14-day period, followed by a seven-day period with three treatments
per day. The primary endpoint of safety, as measured by NO-related SAEs, over the 21-day treatment period was met with no SAEs reported.
Secondary endpoints of a 6MW test FEV1, Quality of Life and M. abscessus load in sputum all trended positively. 6MW showed an increase
of >40 meters at the end of treatment at day 21 versus baseline and an increase of >25 meters on day 81 (60 days after the cessation
of therapy). The mean percentage change in FEV1 at day 21 and day 51 (30 days after the cessation of treatment) was > 3.5% with FEV1
returning to baseline at day 81 (60 days after the cessation of therapy). At day 81 (60 days after the cessation of therapy) bacterial
load was 65% lower than baseline. 1 of 9 patients saw culture conversion. This study was published in the Journal of Cystic Fibrosis in
2019.

16

In 2018, an additional CF patient
infected with M. abscessus was treated over a 4-week period with 76 of 84 treatments at 250 ppm NO in Israel at Soroka Medical
Center. The patient saw improvements in 6MW, FEV1 and most Quality-of-Life measures. The bacteria were not eradicated. Importantly, there
were no SAE’s reported and all treatments were completed without incident.

In December 2020 we began a 12-week,
multi-center, open-label clinical trial in Australia intended to enroll approximately 20 adult patients with chronic refractory NTM lung
disease. We received a grant of up to $2.2 million from the CFF to fund this study and advance the clinical development of inhaled NO
to treat NTM pulmonary disease. The trial enrolled both CF and non-CF patients infected with MAC, M. abscessus or any strain