Company: XAIR
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021561
Chunk: 68

Company: Beyond Air, Inc.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 1
Chunk 68
---
 contemplates the recovery of the Company’s assets and the satisfaction of liabilities
in the normal course of business.

Our
future capital needs and the adequacy of our available funds will depend on many factors, including, but not necessarily limited to,
the cost and time necessary for the development, preclinical studies, clinical trials and certification or regulatory approval of our
other medical devices, indications as well as the commercial success of our approved product and any product candidates that receive
marketing approval by the FDA. We will be required to raise additional funds through sale of equity or debt securities or through strategic
collaborations and/or licensing agreements in order to fund operations until we are able to generate enough product or royalty revenues,
if any. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could have a material
adverse effect on our strategic objectives, results of operations and financial condition.

Our
ability to continue to operate beyond the second fiscal quarter of 2027 will be largely dependent upon the successful commercial launch
of LungFit® PH, as well as obtaining partners in other parts of the world, and raising additional funds to finance our
activities until we are generating cash flow from operations. Further, there are no assurances that we will be successful in obtaining
an adequate level of financing for the development and commercialization of our other product candidates.

There
are numerous risks and uncertainties associated with the development of our NO delivery system and we are unable to estimate the amounts
of increased capital outlays and operating expenses associated with the completion of the research and development of our product candidates.

33

Our
future capital requirements will depend on many factors, including:

    ●
    the
    progress and costs of our preclinical studies, clinical trials and other research and development activities;
  
    ●
    the
    costs of commercializing the LungFit® system;
  
    ●
    the
    scope, prioritization and number of our clinical trials and other research and development programs;
  
    ●
    the
    costs and timing of obtaining certification or regulatory approval for our product candidates;
  
    ●
    the
    costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
  
    ●
    the
    costs of, and timing for, strengthening our manufacturing agreements for production of sufficient clinical quantities of our product
    candidates;
  
    ●
    the
    potential costs of contracting with third parties to provide marketing and distribution services for us