Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 125

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part II, Item 8
Chunk 125
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primary endpoint), oxygen saturation and ICU admission, among others, were assessed.

We
presented results from the pilot clinical trial at the 32nd European Congress of Clinical Microbiology & Infectious Diseases
(ECCMID 2022), which took place from April 23, 2022 through April 26, 2022 as a hybrid event both onsite in Lisbon, Portugal and online.
At the time of the data cut off, the trial enrolled a total of 40 patients hospitalized for VCAP (SARS-CoV-2, n=39; other viruses n=1).
The intent-to-treat population included 35 patients with 16 patients in the inhaled NO group and 19 patients in the control group. The
primary COVID-19 treatments used during the clinical trial were Remdesivir (>30%) and Dexamethasone (>65%). Safety data from the
clinical trial show that inhaled NO treatment was well tolerated overall with no treatment related adverse events as assessed by the
investigators. There were two serious adverse events (“SAEs”) reported in the group receiving inhaled NO along with SST,
which were determined to be related to underlying conditions and unrelated to clinical trial drug/device. From an efficacy perspective,
results show a trend of shortening length of stay (“LOS”) by a factor 1.8 in favor of inhaled NO treatment. Duration of oxygen
support, measured in-hospital and at home, was significantly shorter (p=0.0339) for inhaled NO treated patients. Patients with unstable
oxygen saturation during hospitalization, 66.7% of the inhaled NO treatment group, reached stable saturation of ≥93% during hospital
stay as compared to 26.7% in the SST group.

Following
completion of the clinical trial and the 180-day follow-up period, incremental data were provided in a poster presentation at IDWeek
2022 held from October 19, 2022, through October 23, 2022 in Washington, D.C. In addition to the positive clinical results provided at
ECCMID 2022, the poster showed a larger decline in c-reactive protein (“CRP”) from baseline for patients treated with NO
+ SST compared to the control group. Analysis of the data provides compelling evidence that high concentration NO delivery with the LungFit®
PRO generator and delivery system can be a powerful tool against any type of pneumonia, especially COVID-19. The Company commenced a
clinical trial in