Company: IXHL
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001213900-25-110299
Chunk: 52

Company: Incannex Healthcare Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 8
Chunk 52
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SA clinical trial investigating
IHL-42X in patients with OSA.

We generally expect research and development costs to increase as we
progress our candidates through clinical trials. Although research and development activities are central to our business model, the successful
development of our drug candidates is highly uncertain. There are numerous factors associated with the successful development of our drug
candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this
time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development
programs. Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages
of clinical development, primarily due to the increased size and duration of later stage clinical trials. As a result, we expect our research
and development expenses will increase substantially in connection with our ongoing and planned clinical and preclinical development activities
in the near term and in the future to the extent our development activities are successful. At this time, we cannot accurately estimate
or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of our
drug candidates. Our research and development expenses have varied, and our future research and development expenses may vary, significantly
based on a wide variety of factors such as:

    ●
    the number and scope, rate of progress, expense and
    results of our clinical trials and preclinical studies, including any modifications to clinical development plans based on feedback
    that we may receive from regulatory authorities;

    ●
    per patient trial costs;

    ●
    the number of trials required for approval;

    ●
    the number of sites included in the trials;

18

    ●
    the countries in which the trials are conducted;

    ●
    the length of time required to enroll eligible patients;

    ●
    the number of patients that participate in the trials;

    ●
    the number of doses that patients receive;

    ●
    the drop-out or discontinuation rates of
    patients;

    ●
    the potential additional safety monitoring requested
    by regulatory agencies;

    ●
    the duration of patient participation in the trials
    and follow-up;

    ●
    the cost and timing of manufacturing of our drug candidates;

    ●
    the costs, if any, of obtaining third-party drugs for
    use in our combination trials;

    ●
    the extent of changes in government regulation and