Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 513

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 513
---
 of
NTM. The study 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 begun 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 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 study was evaluating safety, quality of life, physical function, and bacterial load among
other parameters. The mean age of subjects was 62.1 years (range: 22 – 82 years) with the majority female (80%), a distribution
consistent with real-world NTM disease. All 15 subjects 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 study. Patients were followed up for 12 weeks after the 12-week
treatment period was completed.

The Company presented positive
results at the 2022 CHEST annual meeting, further supporting development of intermittent high dose NO for the treatment of NTM. The study
demonstrated that high dose NO treatment was safe and well-tolerated in both the home and hospital settings. During the 10-week at-home
treatment period of the study, 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 and follow-up. Trends in the reduction of microbial load were observed and one subject achieved culture conversion
with three consecutive negative sputum samples. We anticipate commencing a pivotal clinical trial in calendar year 2026 following discussions
with the FDA.

Our program in COPD is in the
preclinical stage and will move forward subject to obtaining additional financing.

In addition to further supporting
development of intermittent high dose NO for the treatment of NTM, we believe this