Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 301

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 301
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 (“UPLs”), on drugs sold in their respective jurisdictions. There are several pending federal lawsuits challenging the
authority of states to impose UPLs, however.

Outside of the United States, particularly in the
European Union, the coverage status and pricing of prescription pharmaceuticals and biologics is subject to governmental control. In these
countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a
product. Furthermore, the requirements may differ across the EU Member States. To obtain coverage and reimbursement or pricing approval
in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our drug candidate to other
available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory
levels, our business could be harmed. Also, at a national level, actions have been taken to enact transparency and anti-gift laws (similar
to the U.S. Physician Payments Sunshine Act) regarding payments between pharmaceutical companies and healthcare professionals.

Our drug candidates contain cannabinoid and psychedelic substances,
the use of which may generate public controversy. Adverse publicity or public perception regarding our current or future drug candidates
may negatively influence the success of these therapies.

Our drug candidates contain cannabinoid and psychedelic
substances that may generate public controversy. Political and social pressures and adverse publicity could lead to delays in approval
of, and increased expenses for our current drug candidates and any future drug candidates we may develop. Opponents of these compounds
may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative
publicity in an effort to persuade the medical community to reject these products, if approved. Adverse publicity from misuse may adversely
affect the commercial success or market penetration achievable by our drug candidates. Anti-cannabinoid and anti-psychedelic protests
have historically occurred and may occur in the future and generate media coverage. Political pressures and adverse publicity could lead
to delays in, and increased expenses for, and limit or restrict the introduction and marketing of, our drug candidates or any future drug
candidates.

If our drug candidates or any future drug candidates
are approved for commercial sale, we will be highly dependent upon consumer perceptions of the safety and quality of our drug candidates.
We may face limited adoption if third-party therapy sites, therapists or patients are unwilling to try such a novel treatment given that
some of our drug candidates are from substances that might be controversial, overlooked or under