Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 186

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 186
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 Although we will likely
seek patent term extensions in the U.S. and in one or more international jurisdictions where available, we cannot provide any assurances
that any such patent term extensions will be granted and, if so, for how long. As a result, we may not be able to maintain exclusivity
for our drug candidates for an extended period after regulatory approval, if any, which would negatively impact our business, financial
condition, results of operations and prospects. If we do not have sufficient patent term or regulatory exclusivity to protect our drug
candidates, our business and results of operations will be adversely affected.

If we are unable to obtain and maintain patent protection for
any drug candidates, our competitors could develop and 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