Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 782

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 782
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. In addition, preclinical and clinical
data are often susceptible to various interpretations and analyses, and many companies that have believed their products performed satisfactorily
in preclinical studies and earlier clinical trials have nonetheless failed to replicate results in later clinical trials. Products in
later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through nonclinical studies
and earlier clinical trials. Failure can occur at any stage of clinical testing. Our clinical trials may produce negative or inconclusive
results, and we may decide, or regulators may require us, to conduct additional clinical and non-clinical testing in addition to those
we have planned.

51

The initiation and completion
of our clinical trials may be prevented, delayed, or halted for numerous reasons. We may experience delays in our ongoing clinical trials
for a number of reasons, which could adversely affect the costs, timing or successful completion of our clinical trials, including related
to the following:

    ●
    we may be required to submit an IDE application to the FDA, which must become effective prior to commencing certain human clinical trials of medical devices, and the FDA may reject our IDE application and notify us that we may not begin clinical trials;

    ●
    regulators and other comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials;

    ●
    regulators and/or an IRB, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site;

    ●
    we may not reach agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

    ●
    clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

    ●
    the number of subjects or patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate;

    ●
    our third-party contractors, including those manufacturing products or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual