Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 583

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 583
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 our clinical
trials if we encounter difficulties in enrollment.

Some of the conditions for which
we plan to evaluate our current product candidates are for rare diseases. For example, we estimate that 15,000 patients suffer from refractory
NTM lung infection in the U.S. Accordingly, there is a limited patient pool from which to draw for clinical trials. Further, the eligibility
criteria of our clinical trials will further limit the pool of available study participants as we will require that patients have specific
characteristics that we can measure or to assure their disease is either severe enough or not too advanced to include them in a study.

Additionally, the process of finding
patients may prove costly. We also may not be able to identify, recruit and enroll a sufficient number of patients to complete our clinical
trials because of the perceived risks and benefits of the product candidate under study, particularly the toxicity of NO in certain doses,
the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective
patients and the patient referral practices of physicians. If patients are unwilling to participate in our studies for any reason, the
timeline for recruiting patients, conducting studies and obtaining certification or regulatory approval of potential products will be
delayed.

If we experience delays in the
completion or termination of any clinical trial of our product candidates, the commercial prospects of our product candidates will be
harmed, and our ability to generate product revenue from any of these product candidates could be delayed or prevented. In addition, any
delays in completing our clinical trials will increase our costs, slow down our product candidate development and certification or approval
process and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may harm our business, financial
condition and prospects significantly. 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.

We may encounter substantial delays in our clinical
trials, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

Before obtaining certification
or marketing approval from regulatory authorities and notified bodies for the sale of our product candidates, we must conduct extensive
clinical trials to demonstrate the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time-consuming
and uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at
all. Our