Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 104

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part II, Item 8
Chunk 104
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 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.

26

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

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 human clinical trial, expansion of preclinical programs for combination studies, hiring of additional Beyond Cancer team
members, and optimization of the delivery system, as well as for general corporate purposes.

Beyond
Cancer will benefit from Beyond Air’s NO expertise, IP portfolio, preclinical