Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 169

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 169
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 to make and keep books and records that accurately and fairly reflect
the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily
regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally,
in many other countries, the healthcare providers who prescribe pharmaceuticals are employed by their governments, and the purchasers
of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under
the FCPA. Recently the SEC and U.S. Department of Justice have increased their FCPA enforcement activities with respect to biotechnology
and pharmaceutical companies. There is no certainty that all of our employees, agents or contractors, or those of our affiliates, will
comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws
and regulations could result in fines, criminal sanctions against us, our officers or our employees, the closing down of our facilities,
requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs
and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products,
if approved, in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our
ability to attract and retain employees and our business, prospects, operating results and financial condition.

We incur, and will continue to incur, costs and expect significantly
increased costs as a result of operating as a public company, and our management is now required to devote substantial time to new compliance
initiatives.

As a public company listed on the Nasdaq Capital
Market, and particularly if we cease to be a “smaller reporting company,” we are incurring and will continue to incur significant
legal, accounting and other expenses that we did not incur as a private company or as a public company without such specified statuses.
We are subject to the reporting requirements of the Exchange Act, as well as various requirements imposed by the Sarbanes-Oxley Act, rules
subsequently adopted by the SEC and Nasdaq to implement provisions of the Sarbanes-Oxley Act, and the Dodd-Frank Wall Street Reform and
Consumer Protection Act. Stockholder activism, the current political environment and the current high level of government intervention
and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs
and impact the manner