Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 275

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 275
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/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 regulation and quotas due to the current status of certain ingredients
as Schedule I controlled substances pursuant to the CSA and applicable DEA regulations. If either we or our CMOs fail to comply with
any of these requirements, we may be subject to regulatory enforcement action, including the seizure of drug candidates and shutting
down of production.

We or our third-party manufacturers may also encounter
shortages in the raw materials or APIs necessary to produce our drug candidates in the quantities needed for our clinical trials or, if
our drug candidates are approved, in sufficient quantities for commercialization or to meet an increase in demand, as a result of demands
from competing businesses, quota restrictions, capacity constraints or delays or disruptions in the market for