Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 587

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 587
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 our on-going clinical, nonclinical and preclinical programs. If CROs do not
successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality
or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements
or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain certification or regulatory
approval for or successfully commercialize our approved product or product candidates. CROs may also generate higher costs than anticipated.
As a consequence, our results of operations and the commercial prospects for our approved product or product candidates would be harmed,
our costs could increase and our ability to generate revenue could be delayed.

Switching or adding additional
CROs involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO
commences work. As a result, delays may occur, which could materially impact our ability to meet our desired clinical development timelines.
Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or
delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and
prospects.

56

We rely on third parties to manufacture
our NO generator and delivery system. Our business could be harmed if those third parties fail to provide us with sufficient quantities
of our needed supplies, or fail to do so at acceptable quality levels or prices. 

We do not currently have the infrastructure
or capability internally to manufacture the components of our NO generator and delivery system, and we lack the resources and the capability
to manufacture our approved product or any of our product candidates on a clinical or commercial scale. We rely on third parties for such
supplies. There are a limited number of manufacturers who have the ability to produce our delivery system, and there may be a need to
identify alternate manufacturers to prevent a possible disruption of our clinical trials. Any significant delay or discontinuity in the
supply of these components could considerably delay commercialization of our approved product, completion of our clinical trials, product
testing and potential certification or regulatory approval of our product candidates, which could harm our business and results of operations.

We and our collaborators and contract manufacturers
are subject to significant regulation with respect to manufacturing our approved product or product candidates. The manufacturing facilities
on which we rely may not continue to meet