Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 514

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 514
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 study breaks new ground in the development of NO therapy
by showing the potential for the Company’s at-home generator-based system to be used safely and consistently by this patient population
in a real-world setting.

17

VCAP and BRO Clinical Development

In 2014, we completed a double
blind, randomized Pilot study for infants with bronchiolitis (n=43) for which the data were published in the Pediatric Pulmonology Journal
in 2017. The study was performed at Soroka University Medical Center in Israel. Forty-three infants between the ages of two to 12 months
diagnosed with bronchiolitis were randomly assigned to either the treatment group or the control group. The treatment group comprised
21 subjects who received intermittent (30 minutes, five times a day) inhalation of 160 ppm NO formulation, in addition to supportive O2
treatment for up to five days. The control group, 22 subjects, received ongoing inhalation of the supportive O2 treatment.
Primary endpoints included determination of the MetHb levels, adverse events associated with the inhaled NO formulation and proportion
of subjects who prematurely discontinued the study. Baseline clinical score, indicating disease severity at screening, was similar between
treatment groups (~8). Results were encouraging, with similar overall incidence of AEs between the treatment groups. Out of 43 patients,
39 (~90%) completed the study per protocol (“PP”), with similar percentages (90%) for both the control and the treatment groups,
individually. Only one subject from the treatment group discontinued treatment due to an adverse event, namely – repeated MetHb
levels above 5%. Adverse events were reported by 23 (53.5%) subjects overall, with ten (47.6%) subjects in the NO group reporting a total
of 22 AEs, and 13 (59.1%) subjects in the control group reporting a total of 22 AEs. SAEs were reported by four (19.0%) subjects in the
NO group and four (18.2%) in the standard treatment group. There were no treatment-related SAEs in the NO treatment group.

In the NO group, six (28.6%) subjects
had any MetHb measurement >5% during the study treatment period, and three of these subjects had more than one MetHb >5%. The maximum
MetHb level was 5.6% in one subject in the NO group. There was no cumulative effect of