Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 515

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 515
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 MetHb exposure during the study. The MetHb levels
in this study were defined to <5% as a safety measure, though previous findings have shown that higher levels (6.4%) are non-toxic
in children. Secondary and exploratory analyses were performed, and results show positive impact of the treatment regime. In a subgroup
of subjects that stayed at the hospital at least 24 hours (LOS >24 hours), a statistically significant treatment benefit of NO versus
standard treatment was demonstrated. Mean results for subjects with LOS > 24 hours show that LOS was shortened by approximately 34%
in the NO group compared to the standard treatment group, with a one-day difference between the groups (PP, N=24). Time to normal oxygenation
(SaO2 of 92%) was shortened by approximately 44% (27.75 hours) in the NO group compared to the standard treatment group (PP, N=24). An
80% improvement in time to clinical score (indicating improvement in disease severity) and time to normal oxygenation (92%) was observed
in favor of the NO group (PP, N=24).

In 2018 we completed a second
pilot study in bronchiolitis in 6 centers in Israel. The data were published in Nature in 2020. The prospective, randomized, double blind,
controlled pilot study enrolled 67 patients, aged 0-12 months, who were hospitalized due to bronchiolitis. The patients received either
SOC (typically oxygen and hydration) or SOC plus inhaled NO at a concentration of 160 ppm for 30 minutes 5 times per day for up to 5 days.
The primary endpoint of hospital LOS was met with a 26.7-hour reduction in hospital length of stay demonstrated (p=0.04). Secondary endpoints
of time required to achieve a clinical score of 5 or less on the modified Tal score and time required to achieve SaO2 of 92%
or greater showed improvement versus the SOC. There were no issues with NO2 or MetHb and no SAEs were recorded.

In 2020 we completed a third pilot
study in bronchiolitis in 8 centers in Israel and presented the data at 2020 CHEST annual meeting. The prospective, randomized, double
blind, controlled pilot study enrolled 89 patients (ITT n=87), aged 0-12 months, who were hospitalized due to bronchiolitis. The patients
were