Company: IXHL
Filing Date: 2025-02-14
Form Type: 10-Q
Source: 0001213900-25-013783
Chunk: 35

Company: Incannex Healthcare Inc.
Filing Date: 2025-02-14
Form: 10-Q
Item: Part I, Item 1
Chunk 35
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 activities.

Our R&D expenses include:

    ●
    external costs associated with services provided by contract research organizations, contract manufacturers, consultants and other third parties to conduct and support our clinical trials and preclinical studies; and

    ●
    internal costs, including R&D personnel-related expenses such as salaries, and benefits, as well as allocated facilities costs and dues and subscriptions.

We expense research and development costs as incurred.

Research and development expenses decreased by
$1.2 million for the three months ended December 31, 2024 compared to the three months ended December 31, 2023. 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.

Research and development expenses decreased by
$1.1 million for the six months ended December 31, 2024 compared to the six months ended December 31, 2023. 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 R&D 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