Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 770

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 770
---
 certification or regulatory approval;

    ●
    require that we suspend or terminate any ongoing clinical trials;

    ●
    refuse to approve pending applications or supplements to applications filed by us;

    ●
    suspend or impose restrictions on operations, including costly new manufacturing requirements;

    ●
    seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall; or

    ●
    exclude us from providing our products to those participating in government health care programs, such as Medicare and Medicaid, and refuse to allow us to enter into supply contracts, including government contracts.

44

The occurrence of any of the foregoing
events or penalties may force us to expend significant amounts of time and money and may significantly inhibit our ability to bring to
market or continue to market our products and generate revenue. Similar regulations apply in foreign jurisdictions.

Risks Related to the Discovery and Development
of Our Product Candidates

We are heavily dependent on the success of our
product candidates, which are in various stages of clinical development. We cannot give any assurance that any of our product candidates
will receive certification or regulatory approval, which is necessary before they can be commercialized.

To date,
we have invested substantially all of our efforts and financial resources to design and develop our product candidates, including conducting
clinical trials and providing general and administrative support for these operations. Our future success is dependent on our ability
to successfully develop, obtain regulatory certification or approval for, and then successfully commercialize one or more product candidates.

Several
of our product candidates are in the early stages of development and will require additional clinical development (and in some cases additional
preclinical development), management of nonclinical, clinical and manufacturing activities, certification or regulatory approval, obtaining
adequate manufacturing supply, building of a commercial organization and significant marketing efforts before we generate any revenue
from product sales. To date, we have conducted 3 pilot clinical trials involving 198 patients with bronchiolitis (mainly caused by RSV)
and a pilot clinical trial in nine patients with CF. In addition, Rambam healthcare campus in Israel conducted a compassionate treatment
for two patients with CF who suffer from NTM infections (specifically M. abscessus). Additionally, two pilot clinical trials were completed
in 2022, one in viral pneumonia and one in NTM lung infection. Both of these studies were using our LungFit® system (PRO and GO, respectively).
Although the results of these trials demonstrated improvements in various endpoints and clinical outcomes