Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 272

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 272
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 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. Delays or failures in planned enrollment or retention of clinical trial subjects may again result
in increased costs or program delays, which could have a harmful effect on our ability to develop a drug candidate or could render further
development impossible.

The
ongoing and future clinical trials of our drug candidates may not show sufficient safety and efficacy to obtain requisite regulatory
approvals for commercial sale.

We
currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. Failure can occur at
any stage of clinical development. Clinical trials may produce negative or inconclusive results, and we or any future collaborators may
decide, or regulators may require us, to conduct additional clinical trials or nonclinical