Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 754

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 754
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 on
our own, we will be unable to generate sufficient product revenue to sustain our business. We may be competing with companies that currently
have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing
and sales functions, we may be unable to compete successfully against these more established companies.

The commercial success of LungFit®
PH and any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payors
and others in the medical community.

Even with approval from the FDA
and potential future certification or approvals from comparable foreign regulatory authorities, the commercial success of LungFit®
PH and our product candidates will depend in part on the medical community, patients and third-party payors accepting LungFit®
PH and our product candidates as medically useful, cost-effective and safe. Any product that we bring to the market may not gain market
acceptance by physicians, patients, third-party payors and others in the medical community. The degree of market acceptance of LungFit®
PH and any of our product candidates that become approved for commercial sale will depend, in part, on a number of factors, including:

    ●
    the safety and efficacy of the product(s) as demonstrated in clinical trials and potential advantages over competing treatments;

    ●
    the prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling;

    ●
    the clinical indications for which certification or approval is granted;

    ●
    
    relative convenience and ease of administration;

    ●
    familiarity of group purchasing organizations with our products;

    ●
    the cost of treatment, particularly in relation to competing treatments;

    ●
    the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

    ●
    the strength of marketing and distribution support and timing of market introduction of competitive products;

    ●
    publicity concerning our products or competing products and treatments; and

    ●
    sufficient third-party insurance coverage and reimbursement.

36

Even if a potential product displays
a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be fully
known until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of the product candidates
may require significant resources and may never be successful. If the LungFit® PH or our product candidates are approved
for commercialization but fail to