Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 16

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 16
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 The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster
or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity
plans, which could have a material adverse effect on our business.

Changes in U.S. federal policy
that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business.
The United States has recently imposed blanket 10% tariffs on virtually all imports to the U.S. and significantly higher so-called reciprocal
tariffs applicable to imports from many countries. On April 9, 2025, the U.S. announced a temporary pause on its reciprocal tariffs applicable
to many countries, while increasing the tariffs applicable to imports from China. The Trump administration has threatened to continue
to broadly impose tariffs, including 50% tariffs on countries in the EU, which could lead to corresponding punitive actions by the countries
with which the U.S. trades. Historically, tariffs have led to increased trade and political tensions, between not only the United States
and China, but also between the United States and other countries in the international community. In response to tariffs, other countries
have implemented retaliatory tariffs on U.S. goods. Political tensions as a result of trade policies could reduce trade volume, investment,
technological exchange and other economic activities between major international economies, resulting in a material adverse effect on
global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions,
including U.S. trade policies, could have a material adverse effect on our financial condition or results of operations.

Future U.S. legislative and
regulatory proposals may materially impact the ability of the FDA and other regulatory agencies to operate as they have historically operated.
In early 2025, the U.S. government began terminating federal agency employees, including at the FDA. The impact of mass layoffs at the
agency and other governmental offices with which we interact is unclear at this time. However, it is expected that with the reductions
in force that have already occurred in 2025, the FDA may experience difficulties in meeting its marketing application review goals or
to continue to be available for timely interactions with medical product developers. We cannot be sure whether additional legislative
changes or executive orders will be enacted, or whether any of the FDA’s regulations, guidances or interpretations will be changed,
or what the impact of such changes on the agency and its scientific review