Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 132

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 132
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could prevent us from achieving or maintaining market acceptance of the affected drug candidates and could substantially increase the
costs of commercializing our drug candidates, and significantly impact our or a partner’s ability to successfully commercialize
drug candidates and generate revenues.

Topline,
interim or preliminary data from our trials may not be representative of final results.

From time to time, we have published and may again
publish or report topline, interim or preliminary data from our clinical trials. Topline, interim or preliminary data from clinical trials
that we may conduct may not be indicative of the final results of the trial and are subject to the risk that one or more of the clinical
outcomes may materially change as patient enrollment continues and/or more patient data become available. Topline, interim or preliminary
data also remain subject to audit and verification procedures that may result in the final data being materially different from the interim
or preliminary data. As a result, topline, interim or preliminary data should be viewed with caution until the final data are available.

49

Because
we rely on third-party manufacturing and supply partners, our supply of R&D, preclinical and clinical development materials may become
limited or interrupted or may not be of satisfactory quantity or quality. If we are able to commercialize any of our drug candidates,
our third-party manufacturers may be unable to scale or fail to comply with their supply obligations to us.

We do not currently have the ability to manufacture
our drug candidates without the use of third parties. We rely, and expect to continue to rely, on third-party supply and manufacturing
partners, such as Procaps and Ardena, to manufacture and supply the materials for our R&D and preclinical and clinical trial supplies,
including those needed for our lead drug candidates. This reliance on third-party manufacturers may expose us to more risk than if we
were to manufacture our drug candidates ourselves. We do not control the manufacturing processes of our CMOs, and we are dependent on
these CMOs for the production of our drug candidates in accordance with cGMP, DEA and other relevant applicable regulations.

In
complying with the manufacturing regulations of the FDA, DEA and other comparable international regulatory authorities, we and our third-party
manufacturers must spend significant time, money and effort in the areas of design and development, testing, production, record-keeping
and quality control to assure that the drug candidates meet applicable specifications and other regulatory requirements. As previously
discussed, our drug candidates are also subject to more stringent