Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 276

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 276
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 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, labor shortage or strike, supply chain disruption, pandemic, accident,
political conflict, hazard, theft, attack or vandalism at our CMOs, or any impacts on our CMOs due to such matters, could significantly
interrupt our R&D capability, and, as applicable, our or a partner’s commercialization efforts. We currently do not have alternative
production plans in place or disaster-recovery facilities available. In case of a disruption, we would have to establish alternative
manufacturing sources. This would require substantial capital on our part, which we may not be able to obtain on commercially acceptable
terms or at all. Additionally, we would likely experience months of manufacturing delays as we build facilities or locate alternative
sup