Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 55

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 1
Chunk 55
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 as a monotherapy and in combination with anti-CTLA-4 versus anti-CTLA-4
alone. Additionally, the data shows that short exposures between 10 seconds to one minute of tumor cells to UNO at increasing concentrations
of 25,000 ppm to 100,000 ppm NO significantly upregulate mPD-L1 expression in a dose and time-dependent manner. Also, in vivo experiments
exhibited a statistically significant day 1 increase in M1 macrophages, decrease in Tregs, and reduction in tumor cell viability was
directionally maintained through day 5. We believe that together with the known ability of NO to activate and recruit the immune system,
the data presented at this year’s AACR annual meeting appears to indicate that repeat dosing of UNO is feasible and may be effective
even in difficult-to-treat, non-immunogenic tumor types.

In
October 2023, Beyond Cancer presented positive pre-clinical data at the EORTC International Conference on Molecular Targets and Cancer
Therapeutics, demonstrating a statistically significant survival benefit in mice treated with UNO plus anti-PD1 versus anti-PD1 alone.
This was a pooled analysis of multiple studies done with 50,000 or 100,000 ppm NO for a single administration of 5 or 10 minutes. Additionally,
Beyond Cancer’s second manuscript was published in the Cells Journal in an article titled “Intratumoral Administration
of High-Concentration Nitric Oxide and Anti-mPD-1 Treatment Improves Tumor Regression Rates and Survival in CT26 Tumor-Bearing Mice.”

27

In
late December 2023, the Company’s safety review committee completed its review of the first 6 human subjects treated with UNO and
reported that there were no dose limiting toxicities at the 25,000 ppm NO concentration and the study may progress to the next concentration
of 50,000 ppm NO.

In
June 2024 at the American Society of Clinical Oncology (ASCO), the Company presented single agent treatment in relapsed or refractory
unresectable, primary or metastatic cutaneous and subcutaneous malignancies at UNO doses of 25,000 and 50,000 parts per million. The
immune biomarker data at Day 21, following a single 5-minute dose of UNO 50,000 ppm, demonstrated increases in dendritic cells, cytotoxic
T-cells, central memory T-cells and a favorable