Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 581

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 581
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 require the enrollment of large numbers of patients, and suitable
patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up
depends on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the
discomforts and risks associated with, the treatments received by enrolled subjects, the availability of appropriate clinical trial investigators,
support staff, and proximity of patients to clinical sites and able to comply with the eligibility and exclusion criteria for participation
in the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial
protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our products
or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts.

We depend on our collaborators
and on medical institutions and CROs to conduct our clinical trials in compliance with Good Clinical Practice (“GCP”) requirements.
To the extent our collaborators or the CROs fail to enroll participants for our clinical trials, fail to conduct the study to GCP standards
or are delayed for a significant time in the execution of trials, including achieving full enrollment, we may be affected by increased
costs, program delays or both. In addition, clinical trials that are conducted in countries outside the United States may subject us to
further delays and expenses as a result of increased shipment costs, additional regulatory requirements and the engagement of non-U.S.
CROs, as well as expose us to risks associated with clinical investigators who are unknown to the FDA, and different standards of diagnosis,
screening and medical care.

Development of sufficient and
appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop such protocols to support
clearance and approval. Further, the FDA may require us to submit data on a greater number of patients than we originally anticipated
and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical trials. Delays
in patient enrollment or failure of patients to continue to participate in a clinical trial may cause an increase in costs and delays
in the approval and attempted commercialization of our products or result in the failure of the clinical trial. In addition, despite considerable
time and expense invested in our clinical trials, the FDA may not consider our data adequate to demonstrate safety and efficacy. Such
increased costs and delays or failures could adversely