Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 285

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 285
---
 authorize pending applications
                                            or supplements to authorized applications we filed or suspension or revocation of marketing
                                            authorizations;

●requirements
                                            to conduct post-marketing studies or clinical trials;

●restrictions
                                            on coverage by third-party payors;

●fines,
                                            restitution or disgorgement of profits or revenues;

●suspension
                                            or withdrawal of marketing approvals;

●product
                                            seizure or detention, or refusal to permit the import or export of the product; and

●injunctions
                                            or the imposition of civil or criminal penalties.

The
FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could
prevent, limit or delay marketing authorization of a product. We cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt
to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance,
we may lose any marketing authorization that we may have obtained and we may not achieve or sustain profitability.

54

Non-compliance
with European Union requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties.
Similarly, failure to comply with the European Union requirements regarding the protection of personal information can also lead to significant
penalties and sanctions.

Future
potential sales of our drug candidates may suffer if they are not accepted in the marketplace by physicians, patients and the medical
community.

There
is a risk that our drug candidates may not gain market acceptance among physicians, patients and the medical community, even if they
are approved by the regulatory authorities. The degree of market acceptance of any of our approved drug candidates will depend on a variety
of factors, including:

●timing
                                            of market introduction, number and clinical profile of competitive products;

●our
                                            ability to provide acceptable evidence of safety and efficacy and our ability to secure the
                                            support of key clinicians and physicians for our drug candidates;

●cost-effectiveness
                                            compared to existing and new treatments;

●availability
                                            of coverage, reimbursement and adequate payment from health maintenance organizations and
                                            other third-party payers;

●prevalence
                                            and severity of adverse side effects; and

●other
                                            advantages over other treatment methods.

As
controlled substances, the products may generate public controversy. Physicians, patients, payers or the medical community may be unwilling
to accept,