Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 129

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 129
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A 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 by our drug candidates;

●our
                                            ability to recruit clinical trial investigators with the appropriate competencies and experience;

●clinicians’
                                            and patients’ perceptions as to the potential advantages of the drug candidate being
                                            studied in relation to other available therapies;

●competing
                                            clinical trials being conducted by other companies or institutions;

●the
                                            risk that participants enrolled in clinical trials will drop out of the trials before completion;

●the
                                            occurrence of epidemics or pandemics and other similar events; and

●the
                                            operational efficiency of trial sites, including sufficient staffing.

In addition, the U.S. Congress recently amended
the FDCA to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug or biologic to support marketing
authorization, to design and submit a diversity action plan for such clinical trial. The action plan must describe appropriate diversity
goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. We or our licensing partners
must submit a diversity action plan to the FDA by the time a Phase 3 trial, or pivotal study, protocol is submitted to the agency for
review, unless we or our licensing partners are able to obtain a waiver for some or all of the requirements for a diversity action plan.
Initiation of such trials may be delayed if the FDA objects to a proposed diversity action plans for any future Phase 3 trial of our drug
candidates, and we or our licensing partners may experience difficulties recruiting a diverse population of patients in attempting to
fulfill the requirements of any approved diversity action plan.

Furthermore,
any negative results we may report in clinical trials may make it difficult or impossible to recruit and retain subjects in other clinical
trials of that same drug candidate