Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 787

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 787
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 be conducted as planned or completed on schedule, if at
all. Our clinical trials involve infants, children, and adults and, before we are permitted to enroll them in clinical trials, we must
demonstrate that although the research may pose a risk to the subjects, there is a prospect of direct benefit to each patient. We must
do so to the satisfaction of each research site’s IRB. If we fail to adequately demonstrate this to the satisfaction of the relevant
IRB, it will decline to approve the research, which could have significant adverse consequences for us.

54

A failure of one or more clinical
trials can occur at any stage of testing, and our future clinical trials may not be successful. Events that may prevent successful or
timely completion of clinical development include but are not limited to:

    ●
    inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation of human clinical trials;

    ●
    delays in reaching a consensus with regulatory authorities on study design;

    ●
    delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

    ●
    delays in obtaining required IRB approval at each clinical trial site;

    ●
    imposition of a clinical hold by regulatory authorities, after review of an IDE application or equivalent application, or an inspection of our clinical trial operations or study sites;

    ●
    delays in recruiting suitable patients to participate in our clinical trials;

    ●
    difficulty collaborating with patient groups and investigators;

    ●
    failure by our CROs, other third parties or us to adhere to clinical trial requirements;

    ●
    failure to perform in accordance with the FDA’s GCP requirements, or applicable regulatory guidelines in other foreign countries;

    ●
    delays in having patients complete participation in a study or return for post-treatment follow-up;

    ●
    occurrence of serious adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

    ●
    changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

    ●
    the cost of clinical trials of our product candidates being greater than we anticipate;

    ●
    clinical trials of our product candidates producing negative or inconclusive results, which may result in us deciding, or regulators requiring us, to conduct additional clinical trials or abandon product development programs; and