Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 269

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 269
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 jurisdiction.
In some cases, the price that we intend to charge for drug candidates is also subject to approval. If we fail to comply with the regulatory
requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability
to realize the full target market potential of our drug candidates will be harmed.

Clinical
drug development involves a lengthy and expensive process with uncertain outcomes. The results of earlier preclinical studies or trials
may not be predictive of the results of later clinical trials. Clinical trials are difficult to design and implement, and any of our
clinical trials could produce unsuccessful results or fail at any stage in the process.

Clinical
trials conducted on humans are expensive and can take many years to complete, and outcomes are inherently uncertain. Failure can occur
at any time during the process. Additionally, any positive results of preclinical studies and early clinical trials of a drug candidate
may not be predictive of the results of later stage clinical trials, such that drug candidates may reach later stages of clinical trials
and fail to show the desired safety and efficacy traits despite having shown indications of those traits in preclinical studies and early-stage
clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials
due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier phases of the trials. Therefore, the
results of any ongoing or future clinical trials we conduct may not be successful.

Our
ongoing or planned clinical trials may also again be delayed, suspended or prematurely terminated because costs are greater than we anticipate
or for a variety of other reasons, such as:

●delay
                                            or failure in reaching agreement with the FDA or a comparable international regulatory authority
                                            on a trial design that we are able to execute;

●delay
                                            or failure in obtaining authorization to commence a trial, including approval from the appropriate
                                            IRB to conduct testing of a candidate on human subjects, or inability to comply with conditions
                                            imposed by a regulatory authority regarding the scope or design of a clinical trial;

●delay
                                            in reaching, or failure to reach, agreement on acceptable terms with prospective CROs, and
                                            clinical trial sites, the terms of which can be subject to extensive negotiation and may
                                            vary significantly among different CROs and trial sites;

46

●inability,
                                            delay or failure in identifying and maintaining a sufficient number of trial sites, many
                                            of which may already be engaged in other clinical programs;

●delay
                                            or failure