Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 302

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 302
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used. There has been a history of negative
media coverage regarding cannabinoid psychedelic substances, including compounds in many of our drug candidates, which may affect the
public’s perception of our drug candidates. In addition, compounds in most of our drug candidates may elicit intense psychological
experiences, and this could deter patients from choosing this course of treatment, if our drug candidates were approved. Our business
could be adversely affected if we were subject to negative publicity or if any of our drug candidates, if approved, or any similar drug
candidates distributed by other companies prove to be, or are asserted to be, harmful to patients. Because of our dependence upon consumer
perception, any adverse publicity associated with illness or other adverse effects resulting from patients’ use or misuse of any
of our drug candidates, if approved or any similar products distributed by other companies could have a material adverse impact on our
business, prospects, financial condition and results of operations.

Future adverse events in research into depression
and other mental health disorders, such as substance use disorder and anxiety, on which we focus our research efforts, or the pharmaceutical
industry more generally, could also result in greater governmental regulation, stricter labeling requirements and potential regulatory
delays in the testing or approvals of our drug candidates. Any increased scrutiny could delay or increase the costs of obtaining regulatory
approval for our drug candidates or any future drug candidates.

The production and sale of our drug
candidates may be considered illegal or may otherwise be restricted due to the use of controlled substances, which may have consequences
for the legality of investments from international jurisdictions.

Our drug candidates contain
controlled substances, including psychedelic substances, which are subject to strict legal requirements in certain jurisdictions where
we will produce and intend to sell our products, if approved. Certain jurisdictions may not allow the use or production of the substances
included in our drug candidates, nor provide any possibilities for an exemption or regulatory approval that could allow for the lawful
use or production of such substances. In addition, these jurisdictions may prohibit any form of contributing to the production or use
of these drug candidates and may also directly or indirectly prohibit the receipt of any benefits following from the production and sale
of these substances. Under circumstances, this may have consequences for the legality of the purchase of our shares or receipt of dividends
in or from international jurisdictions.

If certain international
authorities consider it illegal to invest in our company, this will negatively affect the possibility to commercialize and generate revenue
in the country of interest. Any investigations of authorities against international