Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 329

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 329
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 commercialize products or technology similar or identical to ours, and our ability
to successfully commercialize any drug candidates we may develop, and our technology may be adversely affected.

Our success depends in large part on our ability
to obtain and maintain patent protection in the United States and other countries with respect to our proprietary drug candidates and
other technologies we may develop. We seek to protect our proprietary position by in-licensing intellectual property and filing patent
applications in the United States and abroad relating to our drug candidates and other technologies that are important to our business.
Given that the development of our technology and drug candidates is at an early stage, our intellectual property portfolio directed to
certain aspects of our technology and drug candidates is also at an early stage. We have filed or intend to file patent applications
on core aspects of our technology and drug candidates; however, there can be no assurance that any such patent applications will issue
as granted patents. Furthermore, in some cases, we only have filed provisional patent applications on certain aspects of our technology
and drug candidates, and none of these provisional patent applications is eligible to become an issued patent until, among other things,
we file a non-provisional patent application within 12 months of the filing date of the applicable provisional patent application. Any
failure to file a non-provisional patent application within this timeline could cause us to lose the ability to obtain patent protection
for the inventions disclosed in the associated provisional patent applications. Furthermore, in some cases, we may not be able to obtain
issued claims covering compositions relating to our drug candidates, as well as other technologies that are important to our business,
and instead may need to rely on filing patent applications with claims covering a method of use and/or method of manufacture for protection
of such drug candidates and other technologies. There can be no assurance that any such patent applications will issue as granted patents,
and even if they do issue, such patent claims may be insufficient to prevent third parties, such as our competitors, from utilizing our
technology. Any failure to obtain or maintain patent protection with respect to our and drug candidates could have a material adverse
effect on our business, financial condition, results of operations, and prospects.

Price controls may be imposed in non-U.S. markets, which may
negatively affect our future profitability.

In some countries, particularly EU member states,
Japan, Australia and Canada, the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations
with governmental authorities can take considerable time after receipt of marketing