Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 745

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 745
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’s business before investing in the Company’s securities.

Numerous factors, including the incurring of
significant losses, are relevant to our financial success and any or all such factors could have a disproportionate impact on our bottom
line.

Our ability to implement our business
strategy is subject to numerous risks that you should be aware of before making an investment decision. These are not the only risks we
face. These risks include, among others, that:

    ●
    we are a medical device and biopharmaceutical company with only one FDA/CE-approved product and a limited operating history on which to assess our business, have incurred significant losses since our inception and incurred a net cash used in operating activities for the year ended March 31, 2025 of approximately $38.2 million. As of March 31, 2025, we have an accumulated deficit of approximately $286.3 million and we anticipate losses declining in fiscal 2026 and 2027.

    ●
    we are unable to predict the extent of future losses or when we will become profitable based on the sale of any product, if at all. Even if we succeed in scaling the commercialization of our approved product and succeed in developing and commercializing our product candidates, we may never generate revenue to sustain profitability;

    ●
    we have only one FDA/CE-approved product, and we expect that we will need to raise additional funding before we can expect to become profitable from sales of our products;

    ●
    we are heavily dependent upon the success of our approved product and product candidates (which are in various stages of clinical development), and we cannot provide any assurance that the FDA or comparable foreign regulatory authorities will allow us to conduct further clinical trials;

    ●
    we are in the process of further developing our proprietary NO delivery system, and unexpected delays will adversely impact the timing of our U.S.-based clinical trials and approvals;

    ●
    we might be unable to develop product candidates that will achieve commercial success in a timely and cost-effective manner, or ever;

    ●
    our competitors may develop or commercialize products faster or more successfully than us;

    ●
    because some of the target patient populations of our approved product or product candidates are small, we must be able to successfully identify patients and achieve a significant market share to maintain profitability and growth;

    ●
    we rely on third parties to help conduct our preclinical studies, clinical trials and commercial scale manufacturing;

    ●
    if we are unable to obtain and maintain