Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 105

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part II, Item 8
Chunk 105
---
 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 year 2022 was a time of significant progress for Beyond Cancer. On August 23, 2022, we announced that the first
patient was treated in a first-in-human Phase 1 clinical trial to assess the safety and immune biomarkers of UNO therapy.