Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 128

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 128
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time schedules and deadlines, and a future CRO’s or CMO’s failure to perform those obligations could subject any of our clinical
trials to delays or failure.

Further,
we may also again encounter delays if a clinical trial is suspended or terminated by us, by any IRB or ethics committee, or by the FDA,
EMA, MHRA, or other regulatory authority. A suspension or termination may occur due to a number of factors, including failure to conduct
the clinical trial in accordance with regulatory requirements, inspection of the clinical trial operations or trial site by the FDA,
EMA, MHRA or other regulatory authorities, exposing participants to health risks caused by unforeseen safety issues or adverse side effects,
development of previously unseen safety issues, failure to demonstrate a benefit from using a drug candidate or changes in governmental
regulations or administrative actions. We cannot predict with any certainty the schedule for commencement or completion of any currently
ongoing, planned or future clinical trials.

Many
of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial
of marketing approval for our drug candidates.

If
we experience additional delays in the commencement or completion of, or suspension or termination of, any clinical trial for our drug
candidates, the commercial prospects of the drug candidate could be harmed, and our ability to generate product revenues from the drug
candidate may be delayed or eliminated. In addition, any additional delays in completing our clinical trials will increase our costs,
slow down our drug candidate development and approval process and jeopardize regulatory approval of our drug candidates and our ability
to commence sales and generate revenues. The occurrence of any of these events could harm our business, financial condition, results
of operations and prospects.

47

We
have in the past and may in the future find it difficult to enroll patients in our clinical trials and patients could discontinue their
participation in our clinical trials, which could delay or prevent our current and any future clinical trials of our drug candidates
and make those trials more expensive to undertake.

The
timely completion of clinical trials in accordance with their protocols depends on, among other things, our ability to enroll a sufficient
number of research participants who remain in the trial until its conclusion. Our Phase 2 clinical trial in Australia to assess the safety
and efficacy of IHL-675A was terminated prior to completion due to challenges with patient recruitment. Insufficient data was collected
to make any conclusions on safety or efficacy of IHL-675