Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 578

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 578
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 approval may not be obtained. Beyond
Cancer’s research data has shown that UNO has anticancer properties and elicits an immune response from the host. Beyond Cancer
utilizes an intratumoral UNO technology as a gas delivery of NO at high concentrations to tumors to induce an immune response. Gas based
intratumoral therapies for the treatment of cancer are considered novel and new medical science. Beyond Cancer’s efforts are currently
also focused on utilizing UNO in combination with Keytruda, a PD-1 inhibitor or other PD-1 or PDL-1 inhibitors as a treatment for cancers.
To date, no such gas-based therapy has been approved for commercialization by the FDA or other regulatory agencies. As a result, the processes
and requirements imposed by relevant regulatory authorities in multiple jurisdictions for these future pharmaceutical product candidates
may cause delays and additional costs in obtaining approvals for marketing authorization. Likewise, pharmaceutical regulation as opposed
to medical device regulation, requires different clearance standards than those the Company is currently subject to, in order to conduct
business. As a result, once our subsidiaries go through initial preclinical research and expand into clinical trials, they are likely
to face additional cost burdens in order to get a product candidate to market.

Clinical trials are necessary to support our
future product submissions to the FDA and such trials involve regulatory complexity, are lengthy, iterative and involve working with third
parties, including CROs and patients for enrollment. These and other factors may affect our ability to complete clinical trials and may
lead to delays or failures that would affect our business and financial prospects.

Initiating and completing clinical
trials necessary to support any future PMAs, and additional safety and efficacy data beyond that typically required for a 510(k) clearance,
for our possible future product candidates, will be time-consuming and expensive and the outcome uncertain. Moreover, the results of early
clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable
results in later clinical trials. The results of preclinical studies and clinical trials of our products and product candidates conducted
to date and ongoing or future studies and trials of our current, planned or future products may not be predictive of the results of later
clinical trials, and interim results of a clinical trial do not necessarily predict final results. Our interpretation of data and results
from our clinical trials do not ensure that we will achieve similar results in future clinical trials. In addition, preclinical and clinical
data are often susceptible to various