Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 510

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 510
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(“FEV1”) and other lung function parameters, serum nitrites/nitrates, prothrombin, pro-inflammatory cytokine and chemokine
levels did not differ between baseline and day 5, while MetHb increased during the study period by an average of 0.9%, as expected. These
data suggest that inhalation of 160 ppm NO for 30 minutes, five times a day, for five consecutive days is well tolerated in healthy individuals.

In 2014, we completed a pilot
open label, multi-center study in nine CF patients (≥10 years old). Patients received intermittent (30 minutes, three times a day)
inhalation of 160 ppm NO formulation, five days a week, over a two-week period. The study was performed in two centers, Soroka Medical
Center and Schneider Children’s Medical Center of Israel. The primary endpoints of the study were to determine the MetHb percentage,
adverse events associated with inhaled NO and the percentage of subjects who prematurely discontinued the study due to adverse events
(“AEs”) and/or SAEs, or for any other reason. AEs were reported by five (55.5%) subjects. There were no SAEs related to NO
therapy, no treatment-related withdrawals due to AEs, and no deaths. AEs considered by the investigator as possibly or probably related
to treatment were reported for two (22.2%) subjects. There were no AEs of MetHb elevation >5% or NO 2 elevation >5 ppm
(study safety threshold of MetHb and NO2, respectively). In total, seven cases of hemoptysis were reported in two subjects
and all events were mild in severity. There was no cumulative effect of MetHb exposure during the study. The maximum MetHb level reported
was 4.6%. Several secondary efficacy analyses were conducted in this study, and though the study was not powered for efficacy, results
show various positive effects of the treatment regime. Bacterial and fungal sputum load analysis results were highly variable, though
marked reductions of Methicillin-sensitive Staphylococcus aureus (“MSSA”), Achromabacter, P. aeruginosa, and Aspergillus
were seen in several subjects. These results suggest non-specific targeting of bacteria and fungi that commonly manifest in CF patients.
In subjects with systemic inflammation (CRP >5 mg/mL) at baseline, CR