Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 780

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 780
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2002 No 618,
as amended) (“UK MDR”) was amended to extend the acceptance of CE marked medical devices on the Great Britain market up to
June 30, 2030.

50

We are working on NTM lung infection which is
very rare.

NTM lung infection is a very rare
disease and only a small number of people suffer from this condition. As a result of these small numbers, we may not be able to complete
the study related to NTM or, even if approved, the device for that indication may never be profitable.

We are working on bronchiolitis that usually
is caused by the RSV virus and any related trials we conduct are dependent on a number of factors outside of our control, which may lead
to varied trial results and possibly delays in our plans.

RSV is a seasonal virus (only
in the winter). For any RSV related clinical trial that we pursue, we are heavily dependent on the occurrence and the severity of this
virus. Treating for RSV is highly reliant on the weather conditions in winter. The weather in the winter is not predictable. For example,
if the winter is warm or short, or the RSV infection was not severe enough when we conducted our trial, or the length of stay in the hospital
at the year that trial was conducted was different from previous seasons, then we might miss the optimal trial season or the results can
be significantly different between two seasons or between different countries or even between different sites. Due to these factors, it
may take us longer than anticipated to obtain data from RSV related trials.

Our subsidiaries are exploring novel therapeutic
processes with NO and once they put forth product candidates, those product candidates are likely to be classified as pharmaceutical drugs
by the FDA; pharmaceutical regulation is more stringent than the standards to which our current approved product is subject, and as such,
as our subsidiaries’ research and results expand, the Company’s regulatory and related costs will increase, which may affect
our financial results, in particular, to the extent that these therapies remain investigative and do not lead to the outcomes anticipated.

We expect the novel nature of
our subsidiaries’ product candidates to create challenges in obtaining regulatory approval, and we anticipate that they may likely
be classified as drug product candidates based on the therapeutic processes being created. The FDA has limited experience with the commercial
development of NO-related drug therapies for cancer and autism, respectively. Accordingly, the regulatory approval pathway for such future
product candidates may