Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 54

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 1
Chunk 54
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 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. In November,
at the annual meeting of the Society for Immunotherapy of Cancer (“SITC”), we presented new in vivo combination data that
support the potential of our novel UNO therapy to treat various types of solid tumors in combination with immune checkpoint inhibitor
(“ICI”) therapies, including anti-PD-1. The data presented at SITC appears to indicate that UNO in combination with anti-PD-1
treatment may lead to higher tumor regression rates and prolonged survival. On December 13, 2022, we announced the publication of preclinical
data in the peer-reviewed journal Cancer Cell International (CCI), which showed that our proprietary tumor ablation technology utilizing
UNO induced a potent innate and adaptive immune response that prevented metastases and resulted in a statistically significant survival
benefit.

In
April 2023, Beyond Cancer presented additional preclinical data for UNO therapy in solid tumors during the AACR 2023 annual meeting.
Data showed a statistically significant survival benefit for repeat dosing of UNO compared to anti-mCTLA-4 as monotherapy and repeat
doses of UNO prolonged survival in combination with anti-PD-1 compared to gNO alone. With regard to tumor volume, statistically significant
reductions were observed with repeat dosing of UNO versus anti-mPD-1