Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 126

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 126
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 failure or delay in obtaining regulatory approval in one jurisdiction
may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a
drug candidate, similar international regulatory authorities must also approve the manufacturing, marketing and promotion of the drug
candidate in those countries. Approval and licensure procedures vary among jurisdictions and can involve requirements and administrative
review periods different from, and greater than, those in the United States, including additional nonclinical studies or clinical trials
as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions
outside the United States, a drug candidate must be approved for reimbursement before it can be approved for sale in that 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