Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 783

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 783
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 obligations to us in a timely manner, or at all;

    ●
    we might have to suspend or terminate clinical trials for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;

    ●
    we may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB and/or regulatory authorities for re-examination;

    ●
    regulators, IRBs, or other parties may require or recommend that we or our investigators suspend or terminate clinical research for various reasons, including safety signals or noncompliance with regulatory requirements;

    ●
    the cost of clinical trials may be greater than we anticipate;

    ●
    clinical sites may not adhere to the clinical protocol or may drop out of a clinical trial;

    ●
    we may be unable to recruit a sufficient number of clinical trial sites;

    ●
    regulators, IRBs, or other reviewing bodies may fail to approve or subsequently find fault with our manufacturing processes or facilities of third-party manufacturers with which we enter into agreement for clinical and commercial supplies, the supply of devices or other materials necessary to conduct clinical trials may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply;

    ●
    approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner rendering our clinical data insufficient for certification or approval;

    ●
    our current or future products may have undesirable side effects or other unexpected characteristics; and

    ●
    impacts of regional or global public health crises, such as the COVID-19 pandemic, could adversely affect any clinical trials we are conducting or plan to conduct, including delays or difficulties in enrolling or onboarding patients, initiating clinical sites, or obtaining the requisite certification or regulatory approvals, interruption of key clinical trial activities, or supply chain disruptions that delay or make it more difficult or costly to obtain the supplies and materials we need for clinical trials.

52

Any of these occurrences may significantly
harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement
or completion of clinical trials may also ultimately lead to the denial of certification or regulatory approval of our product candidates.

Clinical trials must be conducted
in accordance with the laws and regulations of the FDA and other comparable foreign regulatory authorities’ legal requirements,
regulations or guidelines, and are subject to oversight by these governmental authorities and IRBs at the medical