Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 569

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 569
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our product candidates will require compliance with complex procedures because concordance between two centers of the FDA (CDRH and CDER)
is necessary for approval of this combination product. A change in the FDA’s prior determination that CDRH would lead the review
of a marketing application for our product candidates would adversely impact our development timeline and significantly raise our costs
to complete clinical development and obtain regulatory approvals.

The success of our business may also depend
upon our ability to identify, license or discover additional product candidates.

Although a substantial amount
of our effort will focus on the continued clinical testing, potential certification, regulatory approval and commercialization of LungFit®
PH and our existing product candidates, the success of our business may also depend upon our ability to identify, license or discover
additional product candidates. Our research programs or licensing efforts may fail to yield additional product candidates for clinical
development for a number of reasons, including but not limited to the following:

    ●
    our research or business development methodology or search criteria and process may be unsuccessful in identifying potential product candidates;

    ●
    we may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates;

    ●
    our product candidates may not succeed in preclinical or clinical testing;

    ●
    our potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the product candidates unmarketable or unlikely to receive certification or marketing approval;

    ●
    competitors may develop alternatives that render our product candidates obsolete or less attractive;

    ●
    product candidates we develop may be covered by third parties’ patents or other exclusive rights;

    ●
    the market for a product candidate may change during our program so that such a product may become unreasonable to continue to develop;

    ●
    a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and

    ●
    a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors.

If any of these events occur,
we may be forced to abandon our development efforts for a program or programs, or we may not be able to identify, license or discover
additional product candidates, which would have a material adverse effect on our business and could potentially cause us to cease operations.
Research programs to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts
and resources on potential programs or product candidates that ultimately prove to be unsuccessful.