Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 271

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 271
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 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-675A We may again encounter delays in enrolling, or be unable to enroll, a sufficient
number of individuals to complete any of our clinical trials, and even once enrolled we may again be unable to retain a sufficient number
of participants to complete any of our trials. Subject enrollment and retention in clinical trials depends on many factors, including:

●the
                                            eligibility criteria defined in the protocol;

●the
                                            size of the patient population required for analysis of the trial’s primary endpoints;

●the
                                            nature of the trial protocol;

●the
                                            proximity of potential subjects to clinical sites;

●the
                                            existing body of safety and efficacy data with respect to the drug candidate;

●side effects or adverse events caused