Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 162

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 2
Chunk 162
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 the Cystic Fibrosis Foundation (“CFF”)
to fund this clinical trial and advance the clinical development of inhaled NO to treat NTM pulmonary disease. The trial enrolled both
cystic fibrosis (“CF”) and non-CF patients infected with MAC, M. abscessus or any strain of NTM. The clinical trial
consisted of a run-in period followed by two treatment phases. The run-in period provided a baseline for the efficacy endpoints. The
first treatment phase took place over a two-week period and began in the hospital setting where patients were titrated from 150 ppm NO
up to 250 ppm NO over several days. During this phase patients received NO for 40 minutes, four times per day while Methemoglobin (“MetHb”)
levels were monitored. Patients were also trained to use LungFit® GO and subsequently discharged to complete the remaining
portion of the two-week treatment period at their home at the highest tolerated NO concentration. For the second treatment phase, a 10-week
maintenance phase, the administration was twice daily. The clinical trial evaluated safety, quality of life, physical function, and bacterial
load among other parameters.

At
the American Thoracic Society International Conference 2022 (ATS 2022), which was held in San Francisco from May 13, 2022 through May
18, 2022, we presented positive interim data from the ongoing clinical trial. At the time of data cutoff on April 4, 2022, a total of
15 patients were enrolled in the pilot clinical trial. The mean age of patients was 62.1 years (range: 22 – 82 years) with the
majority female (80%), a distribution consistent with real-world NTM disease. All 15 patients were successfully titrated to 250 ppm NO
in the hospital setting, and no patients required dose reductions during the subsequent at-home portion of the clinical trial. Patients
were followed up for 12 weeks after the 12-week treatment period was completed.

After
completion of the clinical trial, we presented positive results at the American College of Chest Physicians (“CHEST”) annual
meeting, held from October 16, 2022 through October 19, 2022, further supporting development of intermittent high dose NO for the treatment
of NTM. The clinical trial demonstrated that high dose NO treatment was well-tolerated in both the home and hospital settings. During
the 10-week at-home treatment period of the clinical