Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 500

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 500
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, 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 benefits 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 blood 21 days following gNO treatment. In addition, at the same time point, a marked reduction in the number
of myeloid-derived suppressor cells was observed in the spleen. Results from the in vitro study showed that exposure of six different
cancer cell lines – including human ovarian and pancreatic and mouse lung, melanoma, colon, and breast – to UNO ranging from
10,000 ppm to 100,000 ppm for up to 10 minutes resulted in a dose-dependent cytotoxic response. The higher concentration doses of gNO
led to near-instant cell death, while the lower concentration doses required a longer exposure period to elicit cell death. Cell viability
was assessed using two assays: XTT and clonogenic assay. After one minute of exposure to 25,000 ppm gNO, less than 10% viability was observed
in all cell lines.

The second half of calendar