Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 52

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 1
Chunk 52
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”) 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), 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 2022 American College of Chest Physicians (“CHEST”)
annual meeting, 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 trial, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%). There were
no SAEs related to treatment discontinuations reported over the 12-week treatment or 12-week follow up periods. Key efficacy endpoints
showed strong results with improvement seen in the majority of quality-of-life domains. Respiratory function and physical function were
maintained during treatment