Company: IXHL
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001213900-25-043682
Chunk: 64

Company: Incannex Healthcare Inc.
Filing Date: 2025-05-15
Form: 10-Q
Item: Part I, Item 2
Chunk 64
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 in the United States, where an expedited regulatory pathway may be available. The primary R&D expense
for the period was the Phase 2/3 RePOSA clinical trial investigating IHL-42X in patients with OSA.

Research and development expenses decreased by
$1.5 million for the nine months ended March 31, 2025 compared to the nine months ended March 31, 2024. The decrease was primarily due
to the completion of the IHL-42X safety and pharmacokinetics clinical trial and the pausing of patient recruitment in the Australian Phase
2 clinical trial for IHL-675A in rheumatoid arthritis. This decision was made to reallocate resources for the IHL-675A program and focus
on expanding research efforts in the United States, where an expedited regulatory pathway may be available. The primary R&D expense
for the period was the Phase 2/3 RePOSA clinical trial investigating IHL-42X in patients with OSA.

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