Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 129

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part II, Item 8
Chunk 129
---
® 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 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 and follow-up. Trends in the reduction of microbial load were observed
and one patient 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.

 30 

Ultra-High
Concentration NO (UNO) in solid tumors