Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 573

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 573
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 those additional approvals for the modifications or additional
indications in a timely manner, or at all. Obtaining new approvals can be a time-consuming process, and delays in obtaining required future
approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future
growth.

For those products sold in the
EEA, we must notify our EU notified body if significant changes are made to the products or if there are substantial changes to our quality
assurance systems affecting those products. Obtaining certification can be a time-consuming process, and delays in obtaining required
future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn
would harm our future growth.

Clinical development involves a lengthy and
expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.

Clinical testing is expensive
and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial
process. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of
later-stage clinical trials. Product candidates that have shown promising results in early-stage clinical trials may still suffer significant
setbacks in subsequent advanced clinical trials. There is a high failure rate for product candidates proceeding through clinical trials,
and product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed
satisfactorily through preclinical studies and initial clinical trials. A number of companies in the medical device and biopharmaceutical
industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding
promising results in earlier studies. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses.
We do not know whether any pivotal clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient
to obtain certification or regulatory approval to market our product candidates. Nor do we know whether the FDA will permit us to proceed
directly to pivotal trials without performing pilot trials in the U.S. using the same delivery system that we will seek approval by the
agency.

Legislative or regulatory reforms may make it
more difficult and costly for us to obtain certification, regulatory clearance or approval of any future products and to manufacture,
market and distribute our products after certification, clearance or approval is obtained.

From time to time, legislation
is drafted and introduced in