Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 499

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 499
---
 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 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, pending funding, 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.

10

Ultra-High Concentration NO (UNO) in solid tumors
through majority-owned affiliate Beyond Cancer.

In the fourth calendar quarter
of 2021, Beyond Cancer, our majority-owned affiliate, raised $30.0 million in a private placement of common shares. The investors purchased
a 20% equity ownership in Beyond Cancer, while Beyond Air maintained 80% equity ownership. The funding is being used to accelerate ongoing
preclinical work, including the completion of IND-enabling studies, completion of a Phase 1 clinical trial