Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 131

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 131
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 event that our clinical trials produce undesirable side effects, our trials could
be suspended or terminated and the FDA, EMA or MHRA or comparable international regulatory authorities could order us to cease further
development of or deny approval of our drug candidates for any or all targeted indications. In addition to this, any drug-candidate-related
side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product
liability claims.

Clinical
trials by their nature utilize a sample of the potential patient population. With a limited number of patients, rare and severe side
effects of our drug candidates may only be uncovered with a significantly larger number of patients exposed to the drug candidate. If
our drug candidates receive marketing approval, and we or others identify undesirable side effects caused by these drug candidates (or
any other similar products) after this approval, a number of potentially significant negative consequences could result, including:

●regulatory
                                            authorities may withdraw or limit their approval of our drug candidates;

●regulatory
                                            authorities may require the addition of labeling statements, specific warnings or a contraindication;

●we
                                            may be required to create a medication guide outlining the risks of such side effects for
                                            distribution to patients, or we may be required to implement a REMS in the United States
                                            or a comparable risk mitigation plan in other jurisdictions to ensure that the benefits of
                                            the drug candidate outweigh the risks;

●we
                                            may be required to change the way the drug candidates are distributed or administered, or
                                            change the labeling of the drug candidates;

●we
                                            may be subject to regulatory investigations and government enforcement actions;

●the
                                            FDA or a comparable international regulatory authority may require us to conduct additional
                                            clinical trials or costly post-marketing testing and surveillance to monitor the safety and
                                            efficacy of the drug candidate;

●we
                                            may decide to recall or withdraw drug candidates from the marketplace after they are approved;

●we
                                            could be sued and held liable for injury caused to individuals exposed to or taking our drug
                                            candidates; and

●our
                                            reputation may suffer.

In
addition, adverse side effects caused by any drugs that may be similar in nature to our drug candidates could delay or prevent regulatory
approval of our drug candidates, limit the commercial profile of an approved label for our drug candidates, or result in significant
negative consequences for our drug candidates following and assuming marketing authorization.

If a drug candidate is approved, any of these events