Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 133

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 133
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 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 the raw materials or APIs,
including shortages caused by the purchase of such raw materials or APIs by our competitors or others. The failure by us or our third-party
manufacturers to obtain the raw materials or APIs necessary to manufacture sufficient quantities of our drug candidates would likely delay
and significantly harm our clinical trials and related R&D efforts.

Our
third-party manufacturers are subject to inspection and approval by regulatory authorities, including before we can commence the manufacture
and sale of any of our drug candidates, and thereafter are subject to ongoing inspection from time to time. Our third-party manufacturers
may not be able to comply with cGMP regulations or similar regulatory requirements in or outside of the United States. Our failure, or
the failure of our third-party manufacturers, to comply with applicable regulations could result in regulatory actions, such as the issuance
of notices of inspectional observations, warning letters or sanctions being imposed on us, including clinical holds, fines, injunctions,
civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of drug candidates or commercial
products (if any), operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of
our drug candidates. If any of our third-party suppliers fails to comply with cGMP or other applicable manufacturing regulations, our
ability to develop and, as applicable, commercialize our drug candidates could suffer significant interruptions.

If
our candidates are approved, we would likely need to rapidly scale our manufacturing capabilities, including any capability we may have
through our CMOs. If our CMOs fail to scale as needed, our commercialization efforts, or the commercialization efforts of any partner
we may have, would likely be impaired.

Any
disruption effecting our CMOs, such as a fire, natural disaster,