Company: XAIR
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021561
Chunk: 53

Company: Beyond Air, Inc.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 1
Chunk 53
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 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 having discussions with the FDA in calendar 2026 to identify a path forward.

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

27

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 oncology team, and regulatory progress, and will
pay Beyond Air a single-digit royalty on all future revenues. Beyond Cancer is being led by a seasoned leadership team with experience
in emerging healthcare companies and clinical oncology.

UNO
has shown anticancer properties in preclinical trials by eliciting an immune response from the host. We have released preclinical data
at several medical/scientific conferences showing the promise of delivering NO directly to tumors at concentrations of 20,000 ppm –
200,000 ppm. Results showed that local tumor ablation with NO conveyed anti-tumor immunity to the host. In April 2022, we presented in
vivo and in vitro preclinical data at the American Association for Cancer Research (“AACR”) 2022 annual meeting.
The in vivo study assessed the mode of action following a single 5-minute gaseous NO (“gNO”) treatment which provided
data showing an effect on the primary tumor 14 days post-treatment. These data showed that intratumoral injections of concentrations
of gNO at 20,000 and 50,000 ppm led to increased recruitment of T cells, B cells, macrophages, and dendrocytes to the primary tumor.
An elevated number of T cells and B cells were also detected in the spleen and