Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 788

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 788
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    delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of our product candidates for use in clinical trials or the inability to do any of the foregoing.

Any inability to successfully
complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue. We may
also be required to conduct additional safety, efficacy and comparability studies before we will be allowed to start clinical trials.
Clinical trial delays could also shorten any periods during which our products have patent protection and may allow our competitors to
bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm
our business and results of operations.

Our product candidates may cause undesirable
side effects or have other properties that could delay or prevent their certification or regulatory approval, limit the commercial profile
of an approved label or result in significant negative consequences following marketing approval, if any.

Undesirable side effects caused
by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more
restrictive marketing label or the delay or denial of certification or regulatory approval by the FDA or other comparable foreign regulatory
authorities. There is currently limited data regarding possible side effects for an antimicrobial dosage of NO treatments, such as our
product candidates. Potential side effects of NO treatments may include high MetHb, NO2 toxicity, nose bleeding and low blood
pressure. Results of our studies may identify unacceptable severity and prevalence of these or other side effects. In such an event, our
studies could be suspended or terminated, and the FDA or comparable foreign regulatory authorities or notified bodies could order us to
cease further development of or deny certification or approval of our product candidates for any or all targeted indications.

55

NO-related side effects could
affect patient recruitment, the ability of enrolled patients to complete the study or result in potential product liability claims.

Additionally, if our product candidates
receive certification or marketing approval, and we or others later identify undesirable side effects caused by such products, a number
of potentially significant negative consequences could result, including but not limited to:

    ●
    regulatory authorities and notified bodies may withdraw certification or approvals of such product;

    ●
    regulatory authorities may require additional warnings on the label;

    ●
    we could be sued and held liable for harm caused to patients; and

    ●
    our reputation may suffer.

Any of these events could prevent
us from achieving or